louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01488435: Efficacy and Tolerance of a Follow-On Formula Fed to Children From 36-48 Months of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Infection
Diarrheal Disease
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Children's Medical Center
name: Shanghai, China
First posted: 2011-12-08
Enrollment: 310
Sex: ALL
Minimum age (years): 36
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose is to determine if the consumption of study product has an effect on acute respiratory infections and/or diarrheal disease.


Eligibility criteria: Inclusion Criteria:

* Child 36-48 months of age
* Child is currently attending a daycare and has attended for 6 months or less
* Has consumed cow's milk or a cow's milk-based beverage during the 48 hours prior to randomization
* Signed informed consent

Exclusion Criteria:

* Child who received any food product or supplement containing probiotics or prebiotics in the 15 days prior to randomization
* Child with allergy to gluten or serious concurrent illness that will interfere in the general management of the child
* Child with diarrhea or acute respiratory infection during the 48 hours prior to randomization
* Child's z-score of weight for height \< -3 according to World Health Organization criteria

Primary outcomes:
measure: Acute respiratory infections and diarrheal disease
timeFrame: 28 weeks
Secondary outcomes:
measure: Allergic manifestations
timeFrame: 28 weeks
measure: Systemic antibiotic use
timeFrame: 28 weeks
measure: Duration of acute respiratory infection and diarrheal disease
timeFrame: 28 weeks
measure: Changes in stool patterns
timeFrame: Baseline and 28 weeks
measure: Fecal immune markers
timeFrame: Baseline and 28 weeks
measure: Serum Ferritin status
timeFrame: Baseline and 28 weeks
measure: Incidence of stool parasites
timeFrame: Baseline and 28 weeks
measure: Growth
timeFrame: 28 weeks
measure: Adverse events
timeFrame: 28 weeks
measure: Acceptance of study product
timeFrame: 28 weeks
measure: Serum immune markers
timeFrame: Baseline and 28 weeks
measure: Serum zinc status
timeFrame: Baseline and 28 weeks
Other outcomes:
Locations:
city: Jinhua
country: China
facility: Shi-ji-xing Child Care Center, Jin Dong District
state: Zhejiang
Study officials:
affiliation: Professor of Development and Behavioral Pediatrics, Shanghai Children Medical Center
name: Xingming Jin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li F, Jin X, Liu B, Zhuang W, Scalabrin D. Follow-up formula consumption in 3- to 4-year-olds and respiratory infections: an RCT. Pediatrics. 2014 Jun;133(6):e1533-40. doi: 10.1542/peds.2013-3598. Epub 2014 May 19.
Clinical trial NCT06687863: Effects of Exercise Training and Genetic Factors in Hypertensive Patients with Obstructive Sleep Apnea Sleep
Official title: Effects of Exercise Training on Neurovascular Control, Endothelial Function, Cognitive Functioning and Genetic Factors in Hypertensive Patients with Obstructive Sleep Apnea Sleep
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Exercise Training
Genetic Polymorphism
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2024-11-14
Enrollment: 72
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective is to investigate the effects of exercise training in hypertensive individuals with obstructive sleep apnea (OSA) in neurovascular control taking into account genetic factors. Seventy-two hypertensive patients with OSA \>15 events/hour of sleep revealed by nocturnal polysomnography will be randomized into a control or physical training group. All will be evaluated for the T786 genotypes of the eNOS gene gene. The study will investigate the effect of the exercise program on vascular control in different alleles of the T786 genotypes of the eNOS gene.

Detailed description: Experimental Design. All participants underwent overnight polysomnography study. The apnea-hypopnea index (AHI) will be calculated by total number of respiratory events (apneas and hypopneas) per hour of sleep. Obstructive sleep apnea will be defined as a cessation of respiratory airflow for 10 seconds with thoracoabdominal effort, which was detected by Piezo respiratory effort sensor. Individuals with \>70% of obstructive events were defined as individuals with OSA.

Muscle blood flow will be evaluated by pletismography tecnique.

Heart rate and blood pressure. Heart rate (HR) was beat-by-beat continuously measured during the test obtained in a computer-recorded electrocardiographic tracing. Blood pressure (BP) was monitored noninvasively from an automatic leg blood pressure cuff (nondominant leg) using automated oscillometric device. The systolic, diastolic and mean blood pressures will be registered.

Cardiopulmonary Exercise Test. Maximal exercise capacity was determined by means of a maximal progressive cardiopulmonary exercise test Peak VO2 will be defined as the maximum attained VO2 at the end of the exercise period in which the subject could no longer maintain the walk velocity.

Eligibility criteria: Inclusion Criteria:

* sedentary,
* Hipertensive patients

Exclusion Criteria:

* Severe cardiovascular, respiratory, renal or severe neuropsychiatric disease

Primary outcomes:
measure: Genetic polymorphism and obstructive sleep apnea
timeFrame: 4 months of exercise training
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Linda Massako Ueno Pardi
Study officials:
affiliation: USP
name: Linda M Ueno-Pardi, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02570763: Combining Non-Invasive Brain Stimulation With Cognitive Behavioral Intervention in Substance Use Disorder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Active tDCS
Sham tDCS
Keywords: neurostimulation
comorbidity
tDCS
CBT
anxiety
alcohol
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2015-10-07
Enrollment: 0
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 current study aims to examine the safety and feasibility of utilizing tDCS to enhance affect-laden episodic memory consolidation among adults with co-occurring alcohol use and anxiety disorders who have recently undergone detoxification as a step toward the translational clinical application of this approach.


Eligibility criteria: Inclusion Criteria:

* DSM IV diagnosis of panic disorder (with or without agoraphobia), generalized anxiety disorder, or social anxiety disorder within the past 30 days
* DSM IV diagnosis of alcohol dependence within the last 30 days
* inpatient treatment at Lodging Plus primarily for alcohol (vs. other drug) dependence
* alcohol use in the 30 days preceding the study
* willingness to provide informed consent
* minimum of a sixth grade English reading level (deemed necessary to complete study materials); as determined by their being able to read and understand the consent form.
* Living within reasonable driving distance (1 hour or less) of the Twin Cities to allow for in-person follow-up interviews

Exclusion Criteria:

* lifetime history of psychosis or mania by history.
* cognitive (e.g., dementia) or physical impairment (e.g., blindness) that interferes with study participation report or as judged by PI/study physician.
* Current suicide risk as deemed by the PI and study physician to be serious and ongoing
* any medical condition or treatment with neurological sequelae (e.g., stroke, tumor, loss of consciousness of more than 30 minutes, HIV, seizures)
* history of ECT
* document loss of consciousness (LOC) for longer than 30 minutes or LOC with neurological sequelae
* pregnancy
* Although seizures are not a known risk of tDCS intervention (Fregni et al., 2006; Nitsche et al., 2008), anyone with a history or a risk for seizures will be excluded from the study
* anyone with metal objects implanted in their head or neck
* anyone taking stimulant medications for any reason as we wish to avoid two sorces of neurostimulation

Primary outcomes:
measure: Therapy Content Memory Assessment
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01550263: Psychological Distress and Outcomes in Hip Preservation Patients
Official title: Pre-Operative Psychological Distress and Post-Operative Outcomes in Hip Preservation Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychological Distress
Keywords: Hip Preservation
Hip Arthroscopy
Hip Pain
Psychological distress
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2012-03-09
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients are selected by Dr. Aoki

Brief summary: This is an investigatory study to determine whether high levels of pre-operative psychological distress predict worse outcomes after hip preservation. This is a low risk study and does not alter the treatment or course of care for patients undergoing this procedure

Detailed description: The correlation between increasing psychological distress and worsening surgical outcomes has been extensively documented in patients undergoing spine surgery. However, we have no reason to believe that patients with hip pathology are uniquely exempt from the influence of psychosocial factors. To our knowledge, no study has been done to evaluate the effect of pre-operative psychological distress on outcomes after hip preservation surgery. We therefore propose to use the DRAM to measure pre-operative distress in patients undergoing open or arthroscopic hip preservation surgery and to compare these pre-operative distress scores with post-operative outcomes. We hope the information we gain will allow clinicians to comprehensively evaluate the patient with hip pain and to make more informed choices about operative treatment.

Eligibility criteria: Inclusion Criteria:

1. Primary presenting complaint of hip pain
2. Hip arthroscopy, surgical dislocation and debridement, and/or periacetabular osteotomy performed by Dr. Aoki or Dr. Peters for hip pathology diagnosed by history, clinical examination and/or imaging

Exclusion Criteria:

1. Unable to complete the DRAM questionnaire
2. Patients who do not undergo surgery

Primary outcomes:
measure: Distress and Risk Assessment Method (DRAM) questionaire
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Orthopaedic Center
state: Utah
Study officials:
affiliation: Orthopaedic Center
name: Stephen K Aoki, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05356663: Comparative Effects of Hold Relax Technique and Mulligan Mobilization in Post Operative Knee Joint
Official title: Comparative Effects of Hold Relax Technique and Mulligan Mobilization on Pain, ROM and Function in Post Operative Knee Joint: A Randomised Controlled Trail
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Operative Pain
Keywords: mulligan mobilization with movement
post-operative knee joint
hold relax technique
knee stiffness
range of motion
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the comparative effects of hold relax technique and mulligan mobilization on pain, ROM and function in post operative knee joint.

Detailed description: Stiffness or restricted ROM of the knee joint is a term used commonly to describe any traumatic condition occurring within or around the knee joint. It can result from direct and indirect below and is experienced as pain with activity, local tenderness to palpation, and decreased ability to tolerate tension, which results in decreased movement and functional strength. Post-traumatic knee stiffness and loss of range of motion is a common complication of injuries to the knee area. Immobilization of human knees for several weeks or more can result in stiffness and loss of range of motion in the joints. After knee arthroplasties, cruciate ligament repairs and trauma may lead to contracture of muscles and knee instability. Limitations of joint movements both flexion and extension suggests intraarticular pathology.

Eligibility criteria: Inclusion Criteria:

* Both male and female of age 20 to 40 years

  * Knee pain 3 or more on VAS
  * Patients with grade 3 or more than 3 power of knee muscle
  * Subjects with post traumatic stiffness of knee joint having a minimum of 70 degree of knee flexion

Exclusion Criteria:

* Hypermobile and unstable joint

  * Soft tissue injuries
  * Joint infection and loosening
  * Other complication of post fracture/ TK

Primary outcomes:
measure: Numeric Pain Rating scale
timeFrame: 3 months
measure: Goniometer for Range of motion
timeFrame: 3 months
measure: Time up and go test for functional ability
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jhang
country: Pakistan
facility: Govt. Hospital DHQ
state: Punjab
Study officials:
affiliation: Riphah International University
name: Nosheen Manzoor, MS-OMPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05802563: Machine Learning Enabled Time Series Analysis in Medicine
Official title: Pattern Recognition in Heart Rate Variability Using Fitness Trackers in Cardiovascular Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Heart Failure, Systolic
Keywords: cardiovascular disease
Artificial intelligence
machine learning
Lead sponsor: HagaZiekenhuis
Sponsor class: OTHER
Collaborators: name: Delft University of Technology
First posted: 2023-04-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All included participants will receive an electrocardiogram.

Brief summary: The goal of this observational cohort study is to investigate the potential of fitness trackers in combination with machine learning algorithms to identify cardiovascular disease specific patterns.

Two hundred participants will be enrolled:

1. 50 with heart failure
2. 50 with atrial fibrillation
3. 100 (healthy) individuals without the former two conditions

All participants are given a Fitbit device and monitored for three months. Researchers will compare differences in heart rate variability patterns between the groups and devise a machine learning algorithm to detect these patterns automatically.


Eligibility criteria: Inclusion Criteria:

* systolic heart failure (LVEF \< 35%)
* Atrial fibrillation without heart failure
* Individuals without cardiovascular disease

Exclusion Criteria:

* \> 85 years old
* Recent pulmonary venous antrum isolation procedure (\<1 year)
* (end stage) kidney failure
* (end stage) liver failure
* Study participants with known systemic active inflammatory disease
* Study participants with impaired mental state
* Inability to use a fitness tracker or mobile phone
* Impaired cognition and inability to understand the study protocol

Primary outcomes:
measure: Cardiovascular disease detection with an AI algorithm
timeFrame: Three months
Secondary outcomes:
measure: Detection of absence of cardiovascular disease
timeFrame: Three months
Other outcomes:
Locations:
city: Den Haag
country: Netherlands
facility: HagaZiekenhuis
state: Zuid-Holland
Study officials:
References:
Clinical trial NCT03801135: Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate Anticoagulation
Official title: A Prospective Interventional Study to Investigate Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate Anticoagulation With or Without Coagulation Factors Replacement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Humoral Rejection
Guillain-Barre Syndrome
Miller Fisher Syndrome
CIDP
Good Pasture Syndrome
Hyperviscosity Syndrome
Keywords: Fibrinogen concentrate
Fresh frozen plasma
ROTEM
Fibrinogen
Overall coagulation potential
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Plasma exchange procedures remove procoagulant and anticoagulant factors. Every procedure increases the risk of bleeding and repeated procedures increase the risk of bleeding mostly because lower fibrinogen levels. The aim of study is to define coagulation status of patient after plasmapheresis with different laboratory tests and to investigate the possibility of fibrinogen concentrate replacement for the correction of induced coagulation disorder.


Eligibility criteria: Inclusion Criteria:

* Every patient who will need repeated plasmapheresis treatment in UKC Ljubljana

Exclusion Criteria:

* pregnancy
* coagulation disorders
* Hypertriglyceridemia-induced acute pancreatitis
* hepatic disorders

Primary outcomes:
measure: Effect of plasmapheresis replacement fluid type on fibrinogen level
timeFrame: Right after every plasmapheresis session, during the whole plasmapheresis treatment (usually about 2 weeks)]
Secondary outcomes:
measure: Effect on coagulation tests after plasmapheresis - ROTEM EXTEM
timeFrame: Right after every plasmapheresis session, during the whole plasmapheresis treatment (usually about 2 weeks)]
measure: Effect on coagulation tests after plasmapheresis - ROTEM FIBTEM
timeFrame: Right after every plasmapheresis session, during the whole plasmapheresis treatment (usually about 2 weeks)]
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
state: Gorenjska
Study officials:
References:
Clinical trial NCT01393886: LGCP (Laparoscopic Greater Curvature Plication)
Official title: A Prospective, Open-label Study to Evaluate the Safety and Efficacy of Laparoscopic Greater Curvature Plication (LGCP) in the Treatment of Obese Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Obesity
Keywords: Obesity Surgery
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2011-07-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to find out the safety and efficacy of Laparoscopic Greater Curvature Plication (LGCP) procedure. This study procedure is an alternative restrictive weight loss surgery that has the potential to reduce the complications associated with gastric banding and sleeve gastrectomy by creating a small sized stomach without the use of an implant and without cutting stomach.

Detailed description: STUDY OBJECTIVES: To demonstrate the safety and efficacy of Laparoscopic Greater Curvature Plication (LGCP)

DESIGN: Prospective, open-label, and single center

Eligibility criteria: Inclusion Criteria:

* Subject is at least 18 years of age at the time of enrollment into the study;
* Have a BMI of at least 30;
* Subject is willing to give consent and comply with protocol evaluation and treatment schedules;
* Subject agrees to refrain from any type of weight-loss drug (prescription or OCT) or elective procedure that affect body weight for the duration of the trial; and
* HbA1C\<11%

Exclusion Criteria:

* History of previous malabsorptive bariatric procedures;
* Women of childbearing potential who are pregnant or lactating at the time of screening or at the time of surgery;
* Any condition which precludes compliance with the study;
* History or presence of pre-existing autoimmune connective tissue disease; and
* Use of prescription or over the counter weight reduction medications or supplements within 30 days of the screening visit or the duration of study participation.

This study is a local study (NY, within 50 miles). This study is not a sponsored trial. Therefore, the procedure is not free.

Primary outcomes:
measure: Weight Loss
timeFrame: 12 months
Secondary outcomes:
measure: Morbidity rates
timeFrame: 12 months
measure: Mortality rates
timeFrame: 12 month
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
Study officials:
affiliation: NYU SOM
name: Fielding George, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU SOM
name: Christine Fielding, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU SOM
name: Marina Kurian, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ramos A, Galvao Neto M, Galvao M, Evangelista LF, Campos JM, Ferraz A. Laparoscopic greater curvature plication: initial results of an alternative restrictive bariatric procedure. Obes Surg. 2010 Jul;20(7):913-8. doi: 10.1007/s11695-010-0132-0.
Clinical trial NCT06034886: Expanded Access Protocol of Troriluzole in Patients With Spinocerebellar Ataxia (SCA)
Official title: Intermediate-Size Patient Population Expanded Access Protocol of Troriluzole in Patients With Spinocerebellar Ataxia (SCA)
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: SCA
Spinocerebellar Ataxias
Lead sponsor: Biohaven Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2023-09-13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this expanded access protocol is to provide access to the investigational drug troriluzole in patients with spinocerebellar ataxia (SCA).

Detailed description: This is an Intermediate-Size Patient Population Expanded Access Protocol designed to provide treatment use of troriluzole to patients with spinocerebellar ataxia (SCA) who are considered to be eligible in the clinical judgement of the Investigator/treating physician. The population includes both troriluzole naive patients and patients participating in previous clinical trials with troriluzole (BHV4157-201 and BHV4157-206) who have a confirmed diagnosis of spinocerebellar ataxia.

Eligibility criteria: Key Inclusion Criteria:

* Patient has a confirmed diagnosis of Spinocerebellar Ataxia (SCA), defined as either clinical evidence supporting diagnosis OR confirmed genotypic diagnosis.
* Adequate hepatic function.

Key Exclusion Criteria:

* Patient is known to have acute or chronic liver disease that is clinically significant in the judgement of the Physician.
* Patient has a history of a clinically significant medical condition that would interfere with the patients ability to comply with the expanded access protocol or would place the patient at increased risk.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: