louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02215668: The Effect of Physical Exercise in Reducing Pain in Women Undergoing Mammography
Official title: Impact of Physical Exercise, Aimed at Reducing Pain in Women Who Underwent Mammography.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Side Effects
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2014-08-13
Enrollment: 198
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Mammography is a systematic way in the main programs of screening for breast cancer in women over 40 or 50 years old, according to screening programs, but most research has shown a frequency of discomfort and pain during the examination mammography. This study is a randomized controlled trial, whose intervention will be a sequence of exercises body warming and muscle stretching, performed systematic manner and supervised by a physical educator. It is expected to find in this study a possible impact of physical exercise in reducing pain after mammography examination.

Detailed description: This research aims to evaluate the relationship of pre-mammography guided physical activity and pain after the examination, evaluating the impact of the intervention in a group of patients undergoing upper limb exercise (SLE), compared to another group women not subject exposure (MNE), and another group with lower limb exercise (LLE). This study is a randomized controlled trial, whose intervention will be a sequence of exercises body warming and muscle stretching, performed systematic manner and supervised by a physical educator. It is expected to find in this study a possible impact of physical exercise in reducing pain after mammography examination. The results will be checked by study association between the level of physical activity, body mass index, breast density and reducing the pain effect between groups for comparison of means and variances of values of the visual analogue scale (VAS).

Eligibility criteria: Inclusion Criteria:

* Women: 20 to 69 years old

Exclusion Criteria:

* Cardiovascular disease
* Mental diseases
* Pulmonary diseases
* Steroids use

Primary outcomes:
measure: Decreased pain after mammography.
timeFrame: Decrease in pain after performing mammography, checked10 minutes after the procedure e, measured by visual analog scale.
Secondary outcomes:
Other outcomes:
Locations:
city: Barretos
country: Brazil
facility: Hospital do Cancer de Barretos
state: Sao Paulo
Study officials:
affiliation: Ribeirao Preto Medical School - USP
name: Altacilio A Nunes, MD; Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06109168: Correlation of SpO2/FIO2 Ratio With PaO2/FIO2 Ratio in ARDS Patients in the ICU of H. Adam Malik Hospital
Official title: Correlation of SpO2/FIO2 Ration With PaO2/FIO2 Ratio in Acute Respiratory Distress Syndrome (ARDS) Patients in the ICU of H. Adam Malik Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ards
Lead sponsor: RS H Adam Malik
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intubated patients in ICU

Brief summary: This study to apprehend the relation of SpO2/FiO2 to PaO2/FiO2 in ARDS patients.

Detailed description: Acute Respiratory Distress Syndrome (ARDS) is a life-threatening condition that requires immediate treatment. The measurement of the PaO2/FiO2 (P/F) ratio is the main choice for assessing the severity of ARDS with an invasive method that requires arterial blood gas (ABG) analysis. This study was conducted to determine the relationship between the SpO2/FiO2 ratio and the PaO2/FiO2 ratio in ARDS patients at HAM General Hospital. This observational study used a cross-sectional research method with the total sample of 29 intubated ICU patients diagnosed with ARDS. Patients with congestive heart failure, anemia, and systolic blood pressure \<90 mmHg were excluded from the study. The results of this study showed a positive correlation between the PaO2/FiO2 and SpO2/FiO2 ratios with a correlation coefficient of 0.955 and a p-value of 0.001. There was a relationship between the S/F ratio and the P/F ratio in assessing the severity of ARDS with a p-value of \<0.05. This study shows that the SpO2/FiO2 (S/F) ratio has a good correlation with the PaO2/FiO2 (P/F) ratio in patients with ARDS, so it can be used as a predictor of ARDS and can be beneficial in clinical practice. It should be noted that the SpO2/FiO2 ratio has several factors that can affect its accuracy, so careful assessment is needed.

Eligibility criteria: Inclusion Criteria:

* ARDS patient
* intubarted patient

Exclusion Criteria:

* Cardiac congenital disorder

Primary outcomes:
measure: Correlation of SpO2/FIO2 Ratio with PaO2/FIO2 Ratio in Acute Respiratory Distress Syndrome (ARDS) Patiens in the ICU of H. Adam Malik Hospital
timeFrame: June - August 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Medan
country: Indonesia
facility: RSUP H. ADam Malik
state: SUmatera UTara
Study officials:
References:
Clinical trial NCT01839968: Ex-Vivo Reversion of Platelet Inhibition Induced by Prasugrel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acquired Platelet Disorder
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2013-04-25
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute coronary syndrome who received a loading dose of prasugrel within 6 and 24h.

Brief summary: The purpose of this ex-vivo study is to estimate the optimal platelet quantity necessary to reverse the antiplatelet effects of prasugrel.


Eligibility criteria: Inclusion Criteria:

* Acute coronary syndrome
* Prasugrel loading dose 6-24h before inclusion

Exclusion Criteria:

* Clopidogrel loading dose
* GPIIbIIIa use within 10 days before inclusion
* Known congenital thrombopathy and/or congenital coagulation defect

Primary outcomes:
measure: Platelet reactivity assessed by light transmittance aggregometry (LTA) after ex-vivo normal platelet addition
timeFrame: within the first 6-24 hours after antiplatelet drug loading dose
Secondary outcomes:
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Hospital of Geneva
state: GE
Study officials:
References:
Clinical trial NCT00666068: Effects of Corticotropin Releasing Hormone (CRH) on the Sleep in Patients With Hypopituitarism
Official title: Effects of CRH on the Sleep in Patients With Hypopituitarism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypopituitarism
Keywords: Patients with hypopituitarism
Lead sponsor: Max-Planck-Institute of Psychiatry
Sponsor class: OTHER
First posted: 2008-04-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: In contrast to healthy subjects, patients with hypopituitarism do not exhibit endocrine responses when hormones are injected. This is at least true for those with a complete insufficiency of the anterior pituitary. For example, administration of corticotropin releasing hormone (CRH) is not followed by an increase of ACTH and cortisol. Therefore, "pure" hormone effects can be investigated.

It is well established that hormones of the hypothalamic-pituitary-adrenal axis are involved in sleep regulation. In rodents, CRH decreased slow wave sleep (SWS). In humans, CRH was reported to increase wakefulness and to decrease SWS and REM sleep. Primary objective was therefore to study the effect of CRH on patients with hypopituitarism.

To date, there is no information on sleep of patients with hypopituitarism. Secondary objective is therefore to compare sleep of patients with hypopituitarism with sleep of age-matched healthy controls.


Eligibility criteria: Patients with hypopituitarism

Inclusion Criteria:

* Age 18-75 years
* Complete insufficiency of the anterior pituitary
* Stable hormone substitution for at least 3 months

Exclusion Criteria:

* Hormone excess in the past
* Sleep disorder, e.g. sleep apnea syndrome

Healthy controls

Inclusion Criteria:

* Age 18-75 years

Exclusion Criteria:

* Any medication during 6 week prior to study entry
* Shift work

Primary outcomes:
measure: Sleep-EEG variables, conventionally and quantitatively analyzed
timeFrame: within the first month
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Max Planck Institute of Psychiatry
Study officials:
References:
Clinical trial NCT00097968: Safety/Efficacy of Everolimus and Neoral® in Adult Cardiac Transplant Patients With Established Allograft Vasculopathy
Official title: An Open-Label, Single Arm, Pilot Study of the Renal Safety of Everolimus in Addition to Neoral® in Cardiac Transplant Recipients With Established Allograft Vasculopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Graft Rejection
Keywords: transplant, heart, adult, everolimus
allograft rejection
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2004-12-02
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Everolimus is an immunosuppressive drug that is being studied for preventing acute rejection that can happen after heart transplantation.

It is usually used in combination with other immunosuppressive drugs such as cyclosporine. The purpose of this study is to evaluate the change in kidney function after beginning everolimus, while determining the most effective Neoral® (cyclosporine) dose to take with everolimus, in adult cardiac transplant patients who have had their transplanted heart for at least 1 year and who have cardiac allograft vasculopathy.


Eligibility criteria: Inclusion Criteria:

* Male or female adult with an established cardiac allograft vasculopathy defined as any new luminal irregularity on coronary angiography.
* Patient must be on statins at study entry.
* Patient who is more than 12 months post-transplant.

Exclusion Criteria:

* Patient with a serum creatinine value \>2.0 mg/dL.
* Patient with a biopsy-proven acute rejection episode (\>= ISHLT 3A) within 6 months prior to study entry.
* Patient who had received any investigational drug within 4 weeks prior to study entry.

Primary outcomes:
measure: Change in renal function at 6 assessed by comparing serum creatinine levels at 6 months to baseline values.
Secondary outcomes:
measure: Major Adverse Cardiac Events at 3 and 6 months.
measure: Patient survival at 3 and 6 months.
measure: Treated acute rejection at 3 and 6 months.
measure: Admission to the hospital at 3 and 6 months.
measure: Premature study treatment discontinuation at 3 and 6 months.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Minneapolis
country: United States
facility: University of Minnesota, Fairfield University Hospital
state: Minnesota
city: New York
country: United States
facility: Columbia Presbyterian Medical Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Nashville
country: United States
facility: Midstate Cardiology
state: Tennessee
Study officials:
affiliation: Novartis Pharmaceuticals
name: Richard Dorent, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03559868: Inhibition of Sterile Inflammation by Digoxin
Official title: Inhibition of Sterile Inflammation by Digoxin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Inflammatory Response
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2018-06-18
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To investigate the effect of digoxin on pyruvate kinase isoform 2 (PKM2) binding to pro-inflammatory loci and innate immune inflammatory responses in the peripheral blood in healthy subjects.

Detailed description: To investigate the effect of orally administered digoxin on innate immune inflammatory responses in the peripheral blood of healthy subjects. We hypothesize the reduction in innate immune inflammatory responses will be expected in the peripheral blood with the effect of oral digoxin.

To investigation how human peripheral blood immune cells change their inflammatory responses after exposure to digoxin in vitro.

Eligibility criteria: Inclusion Criteria

1. Age \>18 y ≤ 70 years
2. subjects with normal serum creatinine, normal EKG and currently not taking any medication.

Exclusion criteria

1. Autoimmune liver disease (ANA \> 1/320)
2. Chronic viral hepatitis
3. Hepatocellular carcinoma
4. Complete portal vein thrombosis
5. Extrahepatic terminal disease
6. Pregnancy
7. Treatment with prednisolone or pentoxifyllin for more than 3 days prior to inclusion/start date
8. Active alcohol abuse (\>50 g/day for men and \>40 g/day for women) in the last 3 months
9. AST \> ALT and total bilirubin \> 3 mg/dl in the past 3 months
10. Liver biopsy and/or clinical picture consistent with alcoholic hepatitis
11. Lack of signed informed consent.
12. Known hypersensitivity to digoxin or other forms of digitalis, ventricular fibrillation.
13. Any significant medical conditions, any electrolyte abnormalities, over the counter medications, natural products and prescription drugs.

Primary outcomes:
measure: Lower Levels of Spontaneous Reactive Oxygen Species (ROS) Production
timeFrame: after starting digoxin
measure: Lower Levels of Spontaneous Reactive Oxygen Species (ROS) Production
timeFrame: 1 week after starting digoxin
measure: Lower Levels of Spontaneous Reactive Oxygen Species (ROS) Production
timeFrame: 2 weeks after starting digoxin
measure: Lower Levels of Spontaneous Reactive Oxygen Species (ROS) Production
timeFrame: 3 weeks after starting digoxin
Secondary outcomes:
measure: Investigation of How Human Peripheral Blood Immune Cells Change Their Inflammatory Responses After Exposure to Digoxin in Vitro
timeFrame: 6 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Centre of Clinical Investigation
state: Connecticut
Study officials:
affiliation: Yale University
name: Wajahat Mehal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04207268: Growing Healthy Hearts: A Pilot Randomized Control Trial to Test Gardening as an Intervention to Improve Health
Official title: Growing Healthy Hearts: A Pilot Randomized Control Trial to Test Gardening as an Intervention to Improve Dietary Intake of Fruits and Vegetables and Cardiovascular Disease Risk
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Cardiovascular disease
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2019-12-20
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the effect of group-based nutrition advice plus gardening (intervention) versus group-based nutrition advice alone on dietary intake of fruits and vegetables, physical activity, and lifetime risk for cardiovascular disease (CVD).

Detailed description: Study participants will be randomly assigned to attend group sessions related to gardening with nutrition advice or nutrition advice alone. The main goal of the intervention will be to encourage participants to increase their intake of fruits and vegetables.

Eligibility criteria: Inclusion Criteria:

1. Are at least 20 years old
2. Have transportation and are willing to travel to the Hershey Community Garden
3. Have any two health conditions or risk factors for CVD. These include, but are not limited to:

   1. Any history of cardiovascular disease
   2. Any family history of premature cardiovascular disease
   3. Any history of stroke
   4. High cholesterol
   5. High blood pressure
   6. Overweight/obesity (BMI \>=25)
   7. Diabetes
   8. Current or past Tobacco use

Exclusion Criteria:

1. Currently tends a vegetable garden
2. Moving out of the area in the next 4 months
3. Non-English speaking
4. Pregnant women
5. Participation in a past gardening study
6. Medical conditions or medications that limit ability to freely increase dietary intake of fruits and vegetables (e.g., kidney failure, dialysis)
7. A medical condition that precludes safe pursuit of gardening, i.e., recent heart conditions (e.g., heart failure, stroke, heart attack), recent or pending surgery, severe orthopedic conditions, pending hip/knee replacement, paralysis, dementia, blindness, unstable angina or uncontrolled arrhythmias, or uncontrolled asthma or allergies.
8. History of difficulty obtaining blood samples or fear of needles

Primary outcomes:
measure: Plasma Carotenoids
timeFrame: 4 months
measure: Self-reported dietary intake
timeFrame: 4 months
Secondary outcomes:
measure: Cardiovascular disease risk score
timeFrame: 4 months
measure: Physical activity
timeFrame: 4 months
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State College of Medicine
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine
name: Susan Veldheer, DEd, RD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00777868: A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-108 in Patients With Onychomycosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Onychomycosis
Lead sponsor: Dow Pharmaceutical Sciences
Sponsor class: INDUSTRY
First posted: 2008-10-22
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and effectiveness of two concentrations of IDP-108 in treating patients with onychomycosis


Eligibility criteria: Inclusion Criteria:

* Presence of onychomycosis of the target toenail
* A positive fungal culture from the target toenail

Exclusion Criteria:

* Any disease or condition that might cause nail abnormalities or may interfere with clinical evaluations
* Presence of tinea pedis (athletes foot)
* Female subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study

Primary outcomes:
measure: Change from baseline in area of infected nail
timeFrame: 9 months
Secondary outcomes:
measure: Change from baseline in mycological results
timeFrame: 9 months
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Clinical Research Institute
state: Federal District
city: Mexico City
country: Mexico
facility: Hospital Central Militar
state: Federal District
city: México City
country: Mexico
facility: Hospital General de México
state: Federal District
city: Guadalajara
country: Mexico
facility: Instituto Dermatólogico de Jalisco "Dr. Jose Barba Rubio"
state: Jalisco
city: Zapopan
country: Mexico
facility: Hospital Dr. Ángel Leaño
state: Jalisco
city: Monterrey
country: Mexico
facility: MIRC/OCA Hospital
state: Nuevo León
city: Monterrey
country: Mexico
facility: Centro de Dermatología de Monterrey
state: Nuevo León
city: Monterrey
country: Mexico
facility: Hospital Universitario "José E. González"
state: Nuevo León
city: Chihuahua
country: Mexico
facility: Unidad de Investigación en Salud
city: San Luis Potosí
country: Mexico
facility: Hospital Ignacio Morones Prieto SLP
Study officials:
References:
citation: Tschen EH, Bucko AD, Oizumi N, Kawabata H, Olin JT, Pillai R. Efinaconazole solution in the treatment of toenail onychomycosis: a phase 2, multicenter, randomized, double-blind study. J Drugs Dermatol. 2013 Feb;12(2):186-92.
Clinical trial NCT00719368: Neurophysiological Characterization of Postherniotomy Pain
Official title: Quantitative Sensory Testing in Persistent Postherniotomy Pain Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Pain
Postherniotomy Pain
Neuropathic Pain
Keywords: Groin hernia
pain
chronic
quantitative sensory testing
Persistent postoperative pain
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2008-07-21
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: persistent posthenriotomy patients

Brief summary: Sensory function is different in persistent postherniotomy pain patients than in operated controls, suggesting this to be a neuropathic pain syndrome. By performing quantitative sensory testing, the specific changes in pain patients will be revealed, thereby aiding in designing future treatment trials. MRI scans of the groin regions in pain patients and control patients will be evaluated by senior MRI specialists assessing potential pathology to the region (Mesh, inflammation, edema, funicle etc.) Assessors will be blinded to clinical status, and surgery.


Eligibility criteria: Inclusion Criteria:

* Male patients \>18 yrs
* Inguinal herniotomy \>1 yr previously
* No sign of hernia recurrence
* Unilateral chronic groin pain lasting more than 3 months
* Moderate/severe pain related impairment of everyday activities.

Exclusion Criteria:

* Other causes of persistent pain in groin region (hip, other surgical procedures)

Primary outcomes:
measure: Sensory function
timeFrame: actual
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Danish Pain Research Centre
city: Copenhagen
country: Denmark
facility: Section for Surgical Pathophysiology
Study officials:
affiliation: Rigshospitalet, Copenhagen University, Denmark
name: Eske K Aasvang, M.D.
role: STUDY_DIRECTOR
affiliation: Rigshospitalet, Copenhagen University, Denmark
name: Henrik Kehlet, M.D., Ph. D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aasvang EK, Brandsborg B, Christensen B, Jensen TS, Kehlet H. Neurophysiological characterization of postherniotomy pain. Pain. 2008 Jul;137(1):173-181. doi: 10.1016/j.pain.2007.09.026. Epub 2007 Oct 31.
citation: Aasvang E, Kehlet H. Chronic postoperative pain: the case of inguinal herniorrhaphy. Br J Anaesth. 2005 Jul;95(1):69-76. doi: 10.1093/bja/aei019. Epub 2004 Nov 5. No abstract available.