louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05064007: Sound and Music for Mild Cognitive Impairment
Official title: The Power of Sound and Music Interventions for Older Adults With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-10-01
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Emerging studies in humans found that 40 Hz sound induces neural gamma oscillation and enhanced cognitive function in older adults with and without Alzheimer's Disease. We will compare a 40 Hz music intervention to both 40 Hz sound and music alone in a clinical cohort of older adults with mild cognitive impairment.


Eligibility criteria: Inclusion Criteria:

1. Community-dwelling
2. amnesia mild cognitive impairment
3. Preserved function
4. No dementia

Exclusion Criteria:

1. known diagnosis of schizophrenia or Parkinson's disease;
2. severe hearing impairment;
3. presence of an acute medical or psychiatric condition which would interfere with the subject's ability to follow the study protocol realistically

Primary outcomes:
measure: Change in Cognitive function
timeFrame: Baseline and immediately after the 4-week intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Nursing
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: JUNXIN LI, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04445207: Experimental Expanded Access Treatment With Convalescent Plasma for the Treatment of Patients With COVID-19
Official title: Experimental Expanded Access Treatment With Convalescent Plasma for the Treatment of Patients With COVID-19
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: COVID
Sars-CoV2
Corona Virus Infection
Keywords: COVID-19
Coronavirus
Sars-CoV2
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2020-06-24
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The purpose of this program is to see if giving convalescent plasma to individuals who test positive for COVID-19 may reduce their symptoms and help minimize complications from the illness.

Detailed description: As individuals are exposed to pathogens, the body's immune system works to create antibodies toward those pathogens. These antibodies can be found in the plasma portion of the blood. This plasma is referred to as "Convalescent plasma" and contains these infection fighting antibodies. Through a blood donation, this convalescent plasma is collected from a recovered person and transfused to a sick patient who is still fighting the same virus. This protocol will make convalescent COVID-19 plasma available to individuals who meet the eligibility criteria described.

Eligibility criteria: Inclusion Criteria:

* At least 12 years of age
* Covid-19 Convalescent Plasma (CCP) treatment is in line with the patient's current goals of care (i.e. recipient cannot be DNI status)
* Laboratory confirmed diagnosis of infection with SARS-CoV-2 that is severe or life threatening OR the individual is judged by the treating provider to be at a high risk of progression to severe or life-threatening disease.
* Severe COVID-19 is defined by one or more of the following:

  1. Dyspnea
  2. Respiratory frequency ≥ 30/min
  3. Blood oxygen saturation ≤ 93%
  4. Partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300
  5. Lung infiltrates \> 50% within 24-48 hours
* Life-threatening COVID-19 is defined as one or more of the following:

  1. Respiratory failure
  2. Septic shock
  3. Multiple organ dysfunction or failure

Exclusion Criteria:

* History of prior life-threatening reactions to transfusion of blood products
* Not receiving other therapies that would preclude plasma transfusion

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Medical School
state: Massachusetts
Study officials:
affiliation: UMASS MEDICAL SCHOOL
name: Jonathan Gerber, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03227107: The Evaluation of NETs, Caspase-1 and Cytokines in ARDS Patients
Official title: IRF-1 Regulate Alveolar Macrophage Pyroptosis in Acute Lung Injury and of Which Will be Possible Mechanism
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ARDS
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2017-07-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with ARDS

Brief summary: 1. enrollment criteria and clinical data collection: follow the principles of medical ethics, the development of inclusion and exclusion criteria, select 90 cases of ARDS patients, in the active treatment at the same time, according to the Berlin standard severity of the disease divided into mild group, moderate Group and severe group, according to the prognosis during hospitalization is divided into survival group and death group. BALF specimens were collected on the day of admission to detect the levels of NETs and alveolar macrophages. The acute and chronic health status scoring system Ⅱ (APACHEⅡ) and Murray acute lung injury score, blood routine, creatinine, urea nitrogen, fasting blood glucose, Item, mean arterial pressure, arterial blood gas analysis, oxygenation index; record the patient's mechanical ventilation time and other data;
2. Pearson linear correlation analysis of BALF in the content of NETs, alveolar macrophage coke death level was a positive correlation between the Spearman rank correlation analysis BALF in the NETs content and alveolar macrophage coke death level, APACHE Ⅱ, Murray score, creatinine, Urea nitrogen, fasting blood glucose and other indicators and ARDS severity was positively correlated;
3. To analyze the prognostic factors of different prognostic factors, to evaluate the content of NETs in BALF, the level of alveolar macrophage coke, APACHEⅡ and Murray scores were analyzed by receiver operator characteristic curve (ROC curve) Short - term survival outcome prognostic value.


Eligibility criteria: Inclusion Criteria:

* ARDS patients diagnosis within 3 days
* Over 18 years old but no more than 75 years old

Exclusion Criteria:

* Severe thoracic open trauma
* Pulmonary embolism
* Severe cardiovascular and cerebrovascular disease
* Endocrine system diseases
* Coagulation dysfunction
* Liver and kidney failure
* Malignant tumors
* Cardiogenic pulmonary edema

Primary outcomes:
measure: neutrophil extracellular traps, caspase-1,cytokines measurement
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya hospital of Central South University
state: Hunan
Study officials:
References:
Clinical trial NCT05433207: Post-Marketing Drug Intensive Monitoring Surveillance of EDIROL in Patients With Postmenopausal Osteoporosis
Official title: EDIROL Drug Intensive Monitoring: Post-Marketing Drug Intensive Monitoring Surveillance of EDIROL in Patients With Postmenopausal Osteoporosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postmenopausal Osteoporosis
Lead sponsor: Chugai Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2022-06-27
Enrollment: 1000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Postmenopausal osteoporosis patients who signed the informed consent form and are expected to receive Edirol during the intensive monitoring period.

Brief summary: This is a post-marketing drug intensive monitoring surveillance with an observational, non-interventional design. The objectives are to compare the incidence of hypercalcemia in patients with and without calcium intake (including dietary supplements, excepting calcium from meals), and to monitor the type, incidence, severity, and relevance of other adverse drug reactions,including urolithiasis.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal osteoporosis patients who signed the informed consent form and are expected to receive Edirol during the intensive monitoring period.

  * Patients with postmenopausal osteoporosis
  * Patients who signed the informed consent form
  * Patients who are expected to receive Edirol during planned enrollment period

Exclusion Criteria:

* Exclude if any of the following:

  * Men
  * No osteoporosis
  * Other osteoporosis (not postmenopausal)
* Started Edirol before ICF signature
* Did not sign ICF

Primary outcomes:
measure: the rates of hypercalcemia and 95% confidence intervals for patients with and without calcium preparation intake
timeFrame: one year from Edirol dosing date
measure: the odds ratios of hypercalcemia and 95% confidence intervals for patients with and without calcium preparation intake
timeFrame: one year from Edirol dosing date
measure: the proportion of each type of adverse drug reactions (including hypercalcemia, urolithiasis, etc.)
timeFrame: through study completion, up to one year
measure: the incidence of adverse drug reactions (including hypercalcemia, urolithiasis, etc.)
timeFrame: through study completion, up to one year
measure: the severity of adverse drug reactions (including hypercalcemia, urolithiasis, etc.)
timeFrame: through study completion, up to one year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Study officials:
affiliation: Peking Union Medical College Hospital
name: Weibo Xia
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04259307: Effect of Intensive Nutritional Support in Subacute Stroke Patient
Official title: Effect of Intensive Nutritional Support on Functional Recovery in Subacute Stroke Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Rehabilitation
Nutrition
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Korean Center for Disease Control and Prevention
First posted: 2020-02-06
Enrollment: 97
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Proper nutritional support during early rehabilitation may be beneficial for functional improvements in gaining functional independence and preventing complications in stroke patients. However, there was no consensus of proper amount of nutritional support in stroke patients. In this study, the investigators aimed to clarigy the effects of the intensive nutritional support during comprehensive rehabilitation during subacute phase to improve function in patients with first-ever strokes.


Eligibility criteria: Inclusion Criteria:

* Acute first-ever stroke patients less than 7 days after onset

  * more than 19 years old at stroke onset ③ stroke confirmed by brain CT or MRI

    * body mass index (BMI) \<25 before the comprehensive rehabilitation ⑤ Mini Nutritional Assessment \< 12 before the comprehensive rehabilitation ⑥ Fugl-Meyer assessment \< 85 at 7 days after stroke onset

Exclusion Criteria:

* Transient ischemic stroke

  * Progressive or unstable stroke

    * Pre-existing and active major neurological disease, e.g., spinal cord injury, Parkinson's disease, et al.

      * Pre-existing and active (e.g., on chronic medication) major psychiatric disease, such as major depression, schizophrenia, bipolar disease or dementia ⑤ Advanced liver, kidney, cardiac, or pulmonary disease, e.g., advanced hepatocellular carcinoma, end-stage renal failure, et al.)

        * A terminal medical diagnosis consistent with survival \< 1 year

          * Diabetes mellitus, Hyperlipidemia, Metabolic syndrome, Heart failure) ⑧ Pregnant or lactating women ⑨ Prohibited from taking medication (Omapone Peri 724mL or Winuf Peri 654mL)

Primary outcomes:
measure: Korean modified Barthel Index (K-MBI) at 6 months after onset
timeFrame: 6 months after onset
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT06517407: Para Versus Trans Rectus Stoma Placement for Prevention of Stoma Related Complications
Official title: Para Rectus Versus Trans Rectus Stoma Placement for Prevention of Stoma Related Complications
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stoma Malfunction
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Lateral para rectal or trans rectal stoma exteriorization.

* Stoma site was incised about 3-5 cm from lateral edge of rectus abdominal muscle at para rectus position, or
* at he lateral edge of the rectus abdominal muscle in trans rectal position

Brief summary: Fecal divertion is a surgical procedure by which stoma is constructed through exteriorization of small intestine or large intestine(loop or end stoma).There are many indications for enterostomies such as malignancy, bleeding per rectum, MVO, Volvulus, iatrogenic colon injury, adhesive bands....... etc.

Many factors concerning the operative technique are considered to influence the incidence of stoma related complications such as stoma prolapse, retraction, stenosis, para stomal herniation, para stomal soiling ,oedema and ileus. Site of stoma creation in relation to rectus abdominis muscle is believed to be one of them.

Detailed description: Fecal divertion is a surgical procedure by which stoma is constructed through exteriorization of small intestine or large intestine(loop or end stoma).There are many indications for enterostomies such as malignancy, bleeding per rectum, MVO, Volvulus, iatrogenic colon injury, adhesive bands.

Many factors concerning the operative technique are considered to influence the incidence of stoma related complications such as stoma prolapse, retraction, stenosis, para stomal herniation, para stomal soiling ,oedema and ileus. Site of stoma creation in relation to rectus abdominis muscle is believed to be one of them.

Eligibility criteria: Inclusion Criteria:

* All patient who recieve abdominal enterostomies either elective or emergencies in surgery department of assuit university hospital

Exclusion Criteria:

1. Patient underwent repair of previous abdominal surgery
2. Patient known to have incisional or ventral abdominal hernia

Primary outcomes:
measure: para stomal herniation
timeFrame: 6 months
Secondary outcomes:
measure: a_wound infection b_post operative ilieus c_oedema of the stoma d_soiling around the stoma e:prolapse f: stenosis g:retraction
timeFrame: 6 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university Hospital
Study officials:
References:
citation: Hardt J, Meerpohl JJ, Metzendorf MI, Kienle P, Post S, Herrle F. Lateral pararectal versus transrectal stoma placement for prevention of parastomal herniation. Cochrane Database Syst Rev. 2019 Apr 24;4(4):CD009487. doi: 10.1002/14651858.CD009487.pub3.
Clinical trial NCT06221007: Long-Term Results of Bone Cement in Stapes Surgery
Official title: Evaluation of Long-Term Results of Bone Cement Application in Stapes Surgery and Factors Effective on Results in Stapes Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Otosclerosis
Keywords: stapedotomy
otosclerosis
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Stapedotomy surgeries performed at Pamukkale University ENT clinic since 2011 will be examined retrospectively.

Brief summary: Considering the long-term results of otosclerosis surgery performed in our clinic, it was observed that in addition to the improvement in air conduction hearing, which indicates conductive hearing, which is the main success of the surgery, there was also an improvement in bone conduction hearing, which indicates sensorineural hearing, in patients using bone cement.

Our study aimed to examine the effect of bone cement use in otosclerosis surgery on long-term hearing thresholds and bone conduction.

Detailed description: A retrospective review was conducted on records of patients who underwent stapes surgery between 2012 and 2020.

Comprehensive records were selected, and patients were summoned for clinic visits for thorough examinations. Evaluation encompassed the average of air and bone conduction at 500, 1000, 2000, and 4000 Hz.

Eligibility criteria: Inclusion Criteria:

* Patients over the age of 18 who underwent stapedotomy with a diagnosis of otosclerosis

Exclusion Criteria:

* Inadequate information in files

Primary outcomes:
measure: Incidence of improvement of conductive hearing loss in patients using bone cement
timeFrame: february'2024-april'2024
Secondary outcomes:
measure: Incidence of decrease in bone conduction hearing threshold in patients using bone cement
timeFrame: february'2024-april'2024
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
affiliation: Pamukkale University
name: Fazıl N Ardıç, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02698007: Safety and Benefits of Using Laryngeal Mask Airway to Keep Airway Potency During Fiber-optic Bronchoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Disease Undergoing Elective Bronchoscopy.
Chronic Obstructive Pulmonary Disease
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2016-03-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Bronchoscopy is a method of diagnosis and treatment of common respiratory diseases and lung recognized for many years.

Since the action takes place in the airways and in light of the use of sedation, when performing, the procedure requires caution to keep potent airway and breathing sufficient enough.

Most of the bronchoscopy done without the aid of equipment for advanced airway protection. During the operation done monitoring hemodynamics: such as blood pressure, pulse and respiratory such as percutaneous oxygen saturation and carbon dioxide.

Laryngeal Mask Airway (LMA) - is a tool that has been shown to be effective in securing of airway respiratory activity during positive-pressure ventilation.

Several studies have shown that the use of LMA is a convenient and safe while performing bronchoscopy for airways and lungs. However, most of the studies were for certain patient groups such as children, immuno-compromised patients.

Or benefits and safety LMA in front of intubation during bronchoscopy.

Our aim to assess the safety and efficacy LMA in not mechanically ventilated patients undergoing flexible elective bronchoscopy .

Another objective, to examine whether there is a special group of patients enjoy the LMA more than others.

Patients will be divided randomly into two groups alternately by order, one patient study group and the next one to control.

Study group : LMA is inserted under sedation and used during the procedure.

Control group - performing bronchoscopy under sedation without LMA.

About 50 people are needed each group.


Eligibility criteria: Inclusion Criteria:

* Above 18 y.o
* Competency to sign informed consent.
* Room air oxygen saturation above 95%
* Stable hemodynamically and respiratory during the start procedure.
* Undergoing elective bronchoscopy.

Exclusion Criteria:

* Pregnant women and special groups will not be included in the study.

Primary outcomes:
measure: pulse oximetry <90%,
timeFrame: during bronchoscopy procedure
measure: Percutaneous Carbon Dioxide >55%,
timeFrame: during bronchoscopy procedure
measure: arrhythmia by ecg monitoring.
timeFrame: during bronchoscopy procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Pulmonary Institute,Rabin Medical Center
Study officials:
References:
Clinical trial NCT00975507: ProQuad™ Versus M-M-R II™ and VARIVAX™ in Healthy Children (V221-009)(COMPLETED)
Official title: A Pilot Study to Compare the Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine and the Concomitant Administration of the Currently Licensed VARIVAX™ and M-M-R II™ in Healthy Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Measles
Mumps
Rubella
Varicella
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-09-11
Enrollment: 480
Sex: ALL
Minimum age (years): 12
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will compare Measles, Mumps, Rubella, and Varicella Vaccine (V221) and concomitant administration of Varivax and M-M-R II vaccines in healthy children.


Eligibility criteria: Inclusion Criteria:

* In good health
* Negative clinical history of varicella, shingles, measles, mumps, and rubella

Exclusion Criteria:

* Previous receipt of measles, mumps, rubella and/or varicella vaccine either alone or in combination
* Any immune impairment or deficiency
* Exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to vaccination
* Vaccination with an inactive vaccine with in the past 14 days
* Vaccination with a live vaccine within the past 30 days
* Immune globulin or any blood product administered in the past 3 months

Primary outcomes:
measure: Number of Participants With Postvaccination Varicella Antibody Titer ≥5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL for Subjects Initially Seronegative (a Titer of <0.6 gpELISA Units/mL) to Varicella at Baseline
timeFrame: 6 weeks Postvaccination
Secondary outcomes:
measure: Number of Participants With Postvaccination Measles ELISA Antibody Titer ≥207.8 mIU/mL
timeFrame: 6 weeks Postvaccination
measure: Number of Participants With Postvaccination Varicella Antibody Titer ≥5 gpELISA Units/mL for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA Units/mL at Baseline
timeFrame: 6 weeks Postvaccination
measure: Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥2.0 Ab Units/mL
timeFrame: 6 weeks Postvaccination
measure: Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL
timeFrame: 6 weeks Postvaccination
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Shinefield H, Black S, Digilio L, Reisinger K, Blatter M, Gress JO, Brown ML, Eves KA, Klopfer SO, Schodel F, Kuter BJ. Evaluation of a quadrivalent measles, mumps, rubella and varicella vaccine in healthy children. Pediatr Infect Dis J. 2005 Aug;24(8):665-9. doi: 10.1097/01.inf.0000172902.25009.a1.