louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03352050: Mushroom Effects on Satiety and Gut Health Markers
Official title: Mushroom Effects on Satiety and Gut Health Markers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet Modification
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2017-11-24
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The Investigator will compare the effect of mushrooms to ground beef in an intervention study and measure satiety markers and gut health markers

Detailed description: Subjects will consume their habitual diet and the investigators will compare the acute effect of mushroom consumption on satiety and food intake. Additionally, subjects will consume mushrooms for 10 days and the investigators will measure gut health markers, including short chain fatty acids, microbiota, and fecal weight.

Eligibility criteria: Inclusion Criteria:

* Healthy
* Willing to consume mushrooms or ground beef for 10 days

Exclusion Criteria:

* Disease (chronic)
* Smoking,

Primary outcomes:
measure: satiety
timeFrame: Baseline
Secondary outcomes:
measure: Gut health
timeFrame: 10 days
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: Department of Food Science and Nutrition
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Joanne Slavin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04350450: Hydroxychloroquine Treatment of Healthcare Workers With COVID19 Illness at Montefiore
Official title: Hydroxychloroquine Treatment of Healthcare Workers With COVID19 Illness at Montefiore: a Review of Process Feasibility, Safety, and Clinical Outcomes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: COVID
Coronavirus
COVID-19
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Given the high prevalence of COVID19 illness (both SARS-CoV-2 RT-PCR confirmed and highly suspect cases) among healthcare workers (HCW) within the Montefiore Health System (MHS), hydroxychloroquine (HCQ) will be prescribed to healthcare workers who are at the highest risk for severe COVID19 illness.


Eligibility criteria: Inclusion Criteria:

* Symptomatic with COVID illness (either RT-PCR test confirmed or highly suspect clinical symptoms)
* Call into office within the first 7 days of illness
* Have any of the following high risk conditions:

  * Age \>60
  * HTN, CAD, or chronic heart disease
  * Diabetes
  * Chronic kidney disease
  * Chronic lung disease
  * Active or recent chemotherapy for malignancy
  * Organ transplant
  * Taking Immune-suppressing medications
  * HIV with CD4 \<200 cells/mm3
* Experiencing at least one of the following high risk symptoms:

  * Severe cough
  * Fever 100.0F or greater
  * Diarrhea
  * Shortness of Breath
  * Hypoxia

Exclusion Criteria:

• HCW not meeting high-risk criteria or those with a contraindication to HCQ will not be offered HCQ

Primary outcomes:
measure: Time to resolution of symptoms
timeFrame: up to 4 weeks
Secondary outcomes:
measure: Number of days from onset of illness to symptom resolution
timeFrame: up to 4 weeks
measure: Number of days to return to work
timeFrame: up to 4 weeks
measure: Rate of hospital admission in treated and untreated healthcare workers
timeFrame: up to 4 weeks
measure: Adverse effect of HCQ during treatment
timeFrame: up to 5 days
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Priya Nori, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00011050: Effects of Storage on Lactate in Blood Samples
Official title: Effects of Storage on Plasma Lactate Determinations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: Specimen Handling
Blood
Cryopreservation
Lactic Acid
Sodium Fluoride
Oxalates
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-08-31
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: The purpose of this study is to determine whether laboratory storage of samples affects the amount of lactate over 3 years.

Lactate is a natural substance normally present in the body. Lactate levels can go up for many different reasons, including treatment with nucleotide reverse transcriptase inhibitor drugs. This study will help researchers know if stored blood samples can be used to test lactate levels.

Detailed description: Lactic acidosis syndrome is a complication of therapy with nucleoside reverse transcriptase inhibitor (NRTI) drugs. Measurement of lactate levels is important in clinical trials of antiretroviral treatments. The preferred collection method for determining plasma lactate is with NaF/KOx tubes, while a number of ACTG studies have stored blood in ethylenediaminetetraacetic acid (EDTA) tubes. This study will analyze lactate in samples collected and stored in NaF/KOx and EDTA tubes to investigate the reliability of lactate concentrations over time.

Pre- and post-exercise blood samples are drawn from participants into NaF/KOx and EDTA tubes and a portion is tested for lactate levels immediately. The remaining portions are frozen and tested at 1, 3, 6, 12, 18, 24, and 36 months.

Eligibility criteria: Inclusion Criteria

Participants may be eligible for this study if they:

* Are at least 18 years old.
* Have sufficient forearm veins.

Exclusion Criteria

Participants will not be eligible for this study if they:

* Have a physical disability that prevents forearm exercise.
* Have any known medical reason, such as anemia, for not having 82 ml of blood drawn.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF - San Francisco Gen Hosp
state: California
city: Indianapolis
country: United States
facility: Indiana Univ Hosp
state: Indiana
city: Indianapolis
country: United States
facility: Division of Inf Diseases/ Indiana Univ Hosp
state: Indiana
Study officials:
name: Michael Dube
role: STUDY_CHAIR
name: Kathleen Mulligan
role: STUDY_CHAIR
References:
Clinical trial NCT05040750: Correlation Between Cardiac Markers and Severity of COVID-19
Official title: Correlation Between Cardiac Markers and Severity of COVID-19 in Egyptian Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Event
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-09-10
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all moderate to severe COVID 19 patients who were admitted to ICU

Brief summary: By July 9, 2020, the global pandemic of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection had resulted in over 11.8 million confirmed cases and over 545000 deaths. Patients with a history of cardiovascular disease are especially vulnerable and have a bad prognosis. According to the findings, cardiac injury manifested by cardiac biomarker elevation is detected in a significant number of COVID-19 patients and is linked to poor outcomes and mortality. However, it is unclear how effective cardiac biomarkers are in COVID-19 prognosis and how to use these indicators.

Detailed description: The pandemic of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has led to \>11.8 million confirmed cases with \>545000 deaths worldwide by July 9, 2020 Patients with preexisting cardiovascular conditions are particularly at risk and have poor prognosis data suggest that cardiac injury, manifested by cardiac biomarker elevation, is detected in a sizable of COVID-19 patients and is associated with adverse outcomes and increased mortality. However, how useful cardiac biomarkers are in COVID-19 prognosis and how to utilize these markers have not been well defined The study will include all moderate to severe COVID 19 patients admitted to ICU. Both genders within the age group 18-60 years were included. The primary outcome is the relation between cardiac markers and mortality rate in critically ill COVID 19 patients The secondary outcome is the relationship between cardiac and inflammatory and coagulation markers

Eligibility criteria: Inclusion Criteria:

* all moderate to severe COVID 19 patients who were admitted to ICU.
* Both genders
* age group 18-60 years

Exclusion Criteria:

* a refusal to participate in the study,
* pregnant patients,
* patients aged \<18 or \>60. years,
* recent history of acute myocardial infarction (\< 1 month before admission).

Primary outcomes:
measure: relation between cardiac markers and mortality rate in critically ill COVID 19 patients
timeFrame: 4 month
Secondary outcomes:
measure: relation ship between cardiac and inflammatory and coagulation markers
timeFrame: 4 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Ain Shams University
name: Fathy Tash, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01948050: Pilot Study of Transcranial Stimulation (tDCS)to Relieve Neuropathic Pain in Cancer Patients
Official title: Pilot Study on Safety and Efficacy of the Non-invasive Transcranial Stimulation (tDCS) to Relieve Neuropathic Pain in Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Beth Israel Medical Center
Sponsor class: OTHER
First posted: 2013-09-23
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a pilot study designed to collect preliminary data on safety and efficacy of transcranial direct current stimulation (tDCS) to relieve pain in cancer patients who developed neuropathic pain in the affected area after a surgical intervention, radiation therapy, or chemotherapy to treat the disease.

Detailed description: This is a pilot study that aims to determine the effect of repetitive tDCS stimulation, performed on five consecutive days at intensity of 2 mA, on pain and somatosensory abnormalities in patients with neuropathic pain that followed surgical, radiation or chemotherapeutic treatment, and to evaluate safety of tDCS in the same model.

Eligibility criteria: Adult male and female patients with cancer who developed neuropathic pain in the affected area secondary the surgical procedure, chemotherapy or radiation that meet the following Inclusion/Exclusion criteria:

Inclusion Criteria:

Pain on the side of the lesion

* Spontaneous pain with a score for "worst pain in the last 24 hours" \>4 on a numeric scale 0-10
* Must present the following symptoms and signs:

  * Continuous burning, shooting, or lancinating pain.
  * Presence of hyperesthesia
  * Presence of hyperalgesia (to pinprick) and/or allodynia (to light touch)

Exclusion Criteria:

* Uncontrolled hypertension, uncontrolled diabetes, uncontrolled cardiovascular disease
* Pain/painful conditions unrelated to the cancer or related treatment
* Pregnancy
* History of seizures/epilepsy
* Any implanted devices (e.g. a cardio stimulator, etc)
* Active illegal drug/alcohol abuse
* Unable to follow directions or complete tools in English

Primary outcomes:
measure: Pain Intensity
timeFrame: Assessed at baseline and post tDCS stimulation day 5
Secondary outcomes:
Other outcomes:
Locations:
city: New York, USA
country: United States
facility: Beth Isael Medical Center
state: New York
Study officials:
affiliation: Beth Israel Medical Center
name: Helena Knotkova, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05549050: Correlation Between Interdialytic Weight Gain and Cardiovascular Diseases in Children With End-Stage Kidney Disease Undergoing Hemodialysis
Official title: Correlation Between Interdialytic Weight Gain and Cardiovascular Diseases in Children With End-Stage Kidney Disease Undergoing Hemodialysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: End Stage Renal Disease on Dialysis
Keywords: interdialytic weight gain
cardiovascular
chronic kidney disease
hemodialysis
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 75
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: End-stage kidney disease children aged 2-18 years old

Brief summary: This study aimed to discuss the correlation between interdialytic weight gain and cardiovascular diseases in children with end-stage kidney disease undergoing chronic hemodialysis. The cardiovascular parameters used include left ventricular hypertrophy, systolic and diastolic function, carotid intima-media thickness, myocardial circumferential strain, and strain rate.


Eligibility criteria: Inclusion Criteria:

* End-stage kidney disease (chronic kidney disease stage 5)
* Undergo hemodialysis at least twice a week

Exclusion Criteria:

* History of congenital heart disease
* Critically ill patients with unstable hemodynamic status

Primary outcomes:
measure: Correlation between interdialytic weight gain and cardiovascular diseases in children with end-stage kidney disease undergoing hemodialysis
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: Jakarta
Study officials:
affiliation: Department of Child Health, Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital
name: Henny A Puspitasari, dr. Sp.A(K)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03612050: Meaning Centered Psychotherapy for Palliative Care Patients (MCP-PC)
Official title: Development of Meaning Centered Psychotherapy for Palliative Care Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Palliative Care
Keywords: Palliative care
Despair
Spiritual well-being
Lead sponsor: Fordham University
Sponsor class: OTHER
Collaborators: name: Calvary Hospital, Bronx, NY
First posted: 2018-08-02
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: This randomized, controlled trial evaluates the effectiveness of an adaptation of a well-established brief, structured existential psychotherapy (Meaning Centered Psychotherapy) specifically tailored to the needs of palliative care patients (MCP-PC). Terminally ill patients with cancer who have been hospitalized in a palliative care hospital will be randomly assigned to either MCP-PC or enhanced usual care. Patients will complete a very short battery of self-report measures before the 3-session intervention, and again 2 and 4 weeks later to determine whether treatment has bolstered spiritual and psychological well-being and improved quality of life.


Eligibility criteria: Inclusion Criteria:

* Terminal illness with life expectancy of less than 6 months; hospitalized at a palliative care facility in Bronx NY, English speaking

Exclusion Criteria:

* Cognitive impairment or severe psychiatric symptoms that preclude informed consent or participation in treatment.

Primary outcomes:
measure: Spiritual Well Being
timeFrame: Through study completion (approx 6 weeks)
Secondary outcomes:
measure: Hopelessness
timeFrame: Through study completion (approx 6 weeks)
measure: Acceptance of Death
timeFrame: Through study completion (approx 6 weeks)
measure: Health related Quality of life
timeFrame: Through study completion (approx 6 weeks)
measure: Desire for hastened death
timeFrame: Through study completion (approx 6 weeks)
Other outcomes:
Locations:
Study officials:
affiliation: Fordham University
name: Barry Rosenfeld, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rosenfeld B, Saracino R, Tobias K, Masterson M, Pessin H, Applebaum A, Brescia R, Breitbart W. Adapting Meaning-Centered Psychotherapy for the palliative care setting: Results of a pilot study. Palliat Med. 2017 Feb;31(2):140-146. doi: 10.1177/0269216316651570. Epub 2016 Jul 21.
Clinical trial NCT04761250: The Effect of a Multimodal Lifestyle Program on Male Fertility
Official title: Evaluation of the Effect of a Multimodal Lifestyle Program on Semen Quality and DNA Fragmentation in Male Patients Attending Fertility Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility, Male
Keywords: Male infertility
Semen quality
Lifestyle intervention
Lead sponsor: Regionshospitalet Viborg, Skive
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 26
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A non-pharmacological study, which examines the effect of lifestyle intervention on sperm quality among men in fertility treatment.

The primary endpoint is to increase the total amount of motile sperm in male patients undergoing fertility treatment


Eligibility criteria: Inclusion Criteria:

* Men of couples who are about to start 2nd or 3rd fertility treatment
* \> 18 years old
* Sperm concentration between 2-40 mill./ml

Exclusion Criteria:

* Use of testicular sperm

Primary outcomes:
measure: Increase in the total amount of motil sperm in male patients undergoing fertility treatment
timeFrame: 90 days
Secondary outcomes:
measure: Change in DNA fragmentation index (DFI)
timeFrame: 90 days
measure: Changes in parameters for metabolic syndrome
timeFrame: 90 days
measure: Changes in parameters for metabolic syndrome
timeFrame: 90 days
measure: Changes in parameters for metabolic syndrome
timeFrame: 90 days
measure: Change in plasma lipids
timeFrame: 90 days
Other outcomes:
Locations:
city: Skive
country: Denmark
facility: Fertility Clinic Skive, Skive Regional Hospital
Study officials:
References:
Clinical trial NCT03071250: An Analysis of the Outcomes From Protocolized Perioperative Care for Patients Receiving Total Hip or Knee Arthroplasty
Official title: An Analysis of the Outcomes From Protocolized Perioperative Care for Patients Receiving Total Hip or Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Hip Osteoarthritis
Knee Arthritis
Hip Arthritis
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2017-03-06
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects must meet all of the inclusion and exclusion criteria to be enrolled in the study.

All men and women 18 years and older who underwent total hip arthroplasty or total knee arthroplasty surgery at UAMS between 7/01/2015 and 7/01/2016.

Brief summary: The care for patients receiving total hip and knee arthroplasty at the University of Arkansas for Medical Sciences has followed a structured care pathway since July 2015. This system of perioperative care has focused on preoperative assessment of medical co-morbidities and risks to postoperative functional recovery, anesthetic care focused on postoperative nausea and vomiting prevention and optimizing immediate postoperative functional ability, and aggressive postoperative physical therapy.

This is an observational study to look at the outcomes of this program at University of Arkansas for Medical Sciences. Areas of focus will be hospital length of stay, postoperative narcotic consumption, Visual Analog Scale scores, incidence of postoperative nausea and vomiting, and 30-day readmission rates, and health literacy rates.


Eligibility criteria: Inclusion Criteria:

- All men and women 18 years and older who underwent total hip arthroplasty or total knee arthroplasty surgery at UAMS between 7/01/2015 and 7/01/2016.

Exclusion Criteria:

- none

Primary outcomes:
measure: Length of Stay
timeFrame: 7/1/2015 - 7/1/2016
Secondary outcomes:
measure: narcotic consumption
timeFrame: 7/1/2015 - 7/1/2016
measure: Pain scores
timeFrame: 7/1/2015 - 7/1/2016
measure: 30-day readmission
timeFrame: 7/1/2015 - 7/1/2016
measure: infection
timeFrame: 7/1/2015 - 7/1/2016
measure: PONV
timeFrame: 7/1/2015 - 7/1/2016
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for MEdical Sciences
state: Arkansas
Study officials:
References:
Clinical trial NCT03076450: Evaluation of POC Lung Ultrasound Combined With Pressure-volume Curve to Titration Adjust PEEP for ARDS Lung Recruitment
Official title: Clinical Evaluation of Point-of-care Lung Ultrasound Combined With Pressure-volume Curve to Titration Adjust PEEP for ARDS Lung Recruitment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Keywords: Acute respiratory distress syndrome, ARDS
Point-of-care lung ultrasound,POC-LUS
Pressure-volume curve, PVC
Positive end-expiratory pressure, PEEP
Ultrasound re-aeration score, US-RAS
Lead sponsor: Shanghai Pudong New Area Gongli Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Municipal Commission of Health and Family Planning
First posted: 2017-03-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Using lung ultrasound re-aeration score(LUS-RAS) combined with pressure-volume curve(PVC) adjust maintain positive end-expiratory pressure(PEEP) after recruitment maneuver, to achieve real-time adjustment, reduce ventilation-associated lung injury and the purpose of effective lung recruitment.

Detailed description: The traditional method, set PEEP according to PVC in ARDS mechanical ventilation, lacks morphological evaluation. For point-of-care lung ultrasound(POC-LUS) is non-invasive, real-time, visualization, no need transport patients, getting more and more attention in the ARDS treatment. It has been reported that LUS-RAS is a meaningful assessment in recruitment maneuver. This study will combine POC-LUS with PVC in set the initial peep, and then dynamic record LUS-RAS to feedback regulate PEEP. Using the POC-LUS and maximum oxygenation method to assess lung recruitment effect in experimental group and control group prospectively. The ventilator parameters, state of hemodynamic, arterial blood gas(ABG) in each group will be recorded; Statistical methods will be performed in term to understand the correlation.

Eligibility criteria: Inclusion Criteria:

* patient aged 18 years and older
* ARDS patients with invasive mechanical ventilation

Exclusion Criteria:

* Intracranial hypertension
* Pneumothorax and mediastinal emphysema
* Severe hypoxemia (oxygenation index \<100)
* Hemodynamic instability
* Chest deformity or surgical history
* Affect Lung-ultrasound conditions: subcutaneous emphysema, chest wound etc.

Primary outcomes:
measure: Lung Ultrasound re-aeration score, LUS-RAS
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Pudong
country: China
facility: Gongli Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Pudong New Area Gongli Hospital
name: Qiancheng Luo, MM
role: PRINCIPAL_INVESTIGATOR
References: