louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04550208: Biomechanical Analysis of Different Landing Manoevres
Official title: Biomechanical Analysis of Different Landing Manoevres in Volleyball and Basketball Players
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Landing Biomechanics
Keywords: landing
biomechanics
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 16
Sex: MALE
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy volleyball and basketball players

Brief summary: In this study, three-dimensional biomechanics , by means of lower limb joint angles and moments (opto-electronic system with synchronised force plate), of different landing manoevres will be compared in a population of basketball and volleyball players.

Detailed description: In this study, three-dimensional biomechanics , by means of lower limb joint angles and moments (opto-electronic system with synchronised force plate), of different landing manoevres will be compared in a population of basketball and volleyball players. General as well as more sport-specific jumps will be performed in this study.

Eligibility criteria: Inclusion Criteria:

* volleyball and basketball players
* male

Exclusion Criteria:

* history or surgery of the lower extremities
* history of fractures of the lower extremities

Primary outcomes:
measure: External knee joint moments
timeFrame: comparison between 2 different test moments separated by one week
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Camilla De Bleecker
state: East Flanders
Study officials:
References:
Clinical trial NCT01211808: Effect of Diltiazem on Pharmacokinetics of BMS-914392
Official title: Effect of Diltiazem on the Pharmacokinetics of BMS-914392 and on Heart Rate After Single-dose Administration of BMS-914392 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atrial Fibrillation
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: PRA Health Sciences
First posted: 2010-09-30
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to assess the effects of diltiazem on the pharmacokinetics of single-dose BMS-914392 in healthy subjects.

Detailed description: Protocol designed to evaluate the potential for a drug-drug interaction

Eligibility criteria: Inclusion Criteria:

* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
* Women of childbearing potential (WOCBP) and men must be using an acceptable method of contraception to avoid pregnancy

Exclusion Criteria:

* Current or recent (within 3 months of study drug administration) gastrointestinal disease
* Current or history of neurological diseases or psychiatric disorders and cardiovascular diseases

Primary outcomes:
measure: Pharmacokinetics of single dose of BMS-914393 derived from serial measurements of BMS-914392 plasma concentrations
timeFrame: Pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72, and 96 hours after dosing of BMS-914392 alone or in combination with diltiazem
Secondary outcomes:
measure: The effect of multiple doses of BMS-914392 on PR, QRS, RR, and QTc intervals derived from serial electrocardiograms (ECGs)
timeFrame: Pre-dose and 0.5 Hr, 1 Hr, 1.5 Hr, 2 Hr, 3 Hr, 4 Hr , 6 Hr, 8 Hr, 12 Hr, 24 Hr after dosing of BMS-914392 alone or in combination with diltiazem
measure: Number of subjects with adverse events as a measure of safety and tolerability of BMS-914392
timeFrame: Daily
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: Pra International
state: Kansas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT05744908: Pentosan Polysulfate Treatment's Effectiveness
Official title: Retrospective Evaluation of the Effectiveness of Oral Pentosan Polysulfate Treatment in the Improvement of Chronic Interstitial Cystitis Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Interstitial Cystitis
Lead sponsor: Hisar Intercontinental Hospital
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: two models: with and without Hunner's ulcer
Primary purpose: TREATMENT

Brief summary: To examine the relationship between symptoms and quality of life before and after oral pentosan polysulfate (PPS) treatment in cases diagnosed with interstitial cystitis/painful bladder syndrome (IC/BPS).

Detailed description: Demographic characteristics, medical history, clinical conditions, and laboratory and cystoscopic data of patients who applied to our clinic between January 2018 and December 2021 and were diagnosed with IC/BPS were retrospectively analyzed. Adult male and female patients with IC/BPS who received 300 mg/day PPS at least six months ago with complaints of pain, urge, frequency, and nocturia not associated with urinary tract infection were included in the study. In addition, pre- and post-treatment symptoms, ICSI scores, quality of life (scored between 1-4), and satisfaction were compared.

Eligibility criteria: Inclusion Criteria:

* Chronic interstitial cystitis
* Bladder Pain Syndrome

Exclusion Criteria:

* Acute cystitis
* Bladder cancer
* Chronic prostatitis
* Bladder stone
* Stress incontinence

Primary outcomes:
measure: bladder wall thickness
timeFrame: Three months
measure: improvement of lower urinary tract symptoms
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Basri Cakiroglu
city: Istanbul
country: Turkey
facility: Hisar Intercontinental Hospital
Study officials:
References:
Clinical trial NCT01135823: Symptom Assessment With Patient Surveys
Official title: Symptom Assessment With Patient Surveys
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinomas
Squamous Cell Carcinoma
Adenocarcinoma
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2010-06-03
Enrollment: 100
Sex: ALL
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: These patients will be pediatric oncology patients who have received chemotherapy within the prior four weeks and being seen in the oncology clinic for an out-patient visit.

Brief summary: The primary purpose of the proposed research is to explore methods of obtaining symptom assessments from pediatric oncology patients and/or their caregivers in hopes of improving the accuracy and thoroughness of these reports. Additionally the researchers hope to simply staff efforts in obtaining detailed medical histories from pediatric oncology patients.


Eligibility criteria: Inclusion Criteria:

* Approximately 150 patients ages 0-18 years (75 for each group-intervention and control) will be enrolled.
* These patients will be pediatric oncology patients who have received chemotherapy within the prior four weeks and being seen in the oncology clinic for an out-patient visit.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Christina Baggott NP RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01785823: Fentanyl Background Infusion for Acute Postoperative Pain
Official title: The Efficacy of the Time-scheduled Decremental Continuous Infusion of Fentanyl for Postoperative Patient-controlled Analgesia After Total Intravenous Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia Disorder
Keywords: analgesia
fentanyl
total intravenous anesthesia
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2013-02-07
Enrollment: 99
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We investigated the efficacy and the safety of the pharmacokinetic model-based patient-controlled analgesia (PCA) regimens of fentanyl for postoperative analgesia after total intravenous anesthesia (TIVA).

Detailed description: Infusions of fentanyl (2 ml/hr of diluent was equivalent with 0.5 μg/kg/hr of fentanyl) were maintained at the fixed-rate of 2 ml/hr until the postoperative 24 hr, or at the decremental rates of 6.0 ml/hr or 8.0 ml/hr during 1 hr, 4.0 ml/hr during 1\~3 hr and 2.0 ml/hr during 3\~24 hr, postoperatively.

Eligibility criteria: Inclusion Criteria:

* patients who had undergone patient-controlled analgesia (PCA) after hysterectomy

Exclusion Criteria:

* neurologic disorders
* psychiatric disorders
* renal or hepatic disorders

Primary outcomes:
measure: visual analogue scores (VAS)
timeFrame: until post-operative 24 hrs
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University School of Medicine
state: Gyeongki-do
Study officials:
affiliation: Ajou University
name: Jong Yeop Kim, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01109823: Pharmacokinetic Evaluation of Fluoroquinolone Antibiotics Administered Intravenously in Intensive Care Patients With Normal Renal Function and With Renal Hyperfiltration
Official title: Pharmacokinetic Evaluation of Fluoroquinolone Antibiotics Administered Intravenously in Intensive Care Patients With Normal Renal Function and With Renal Hyperfiltration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infection
Keywords: Patients hospitalized at Intensive Care Unit treated with levofloxacin IV
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2010-04-23
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: At the intensive care unit (ICU) fluoroquinolone antibiotics, like levofloxacin, are frequently used for the treatment of infections.

Adequate blood levels are required for a good efficacy of the antibiotic. Due to the fact that levofloxacin is almost completely eliminated renally, the blood levels for this antibiotic are strongly influenced by the renal function. Therefore, this study aims to evaluate the pharmacokinetics of levofloxacin in patients with hyperfiltration, in comparison with critically ill patients with normal renal function.


Eligibility criteria: Inclusion Criteria:

* Patients hospitalized at the Department Intensive Care Unit who are being treated with levofloxacin I.V. (500mg, twice daily) for an infection.

Exclusion Criteria:

* Younger than 18 years
* No informed consent
* No arterial catheter
* Hematocrit ≤ 21
* Pregnancy and lactation
* Creatinine clearance \< 80 ml/min

Primary outcomes:
measure: to evaluate the pharmacokinetics of levofloxacin in patients with hyperfiltration, in comparison with critically ill patients with normal renal function.
timeFrame: 12 hours after start antibiotic treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Ghent
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Ghent
name: Jan Van Bocxlaer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01653223: Myocardial Protection Effect of Simvastatin Undergoing Cardiac Surgery
Official title: A Study of Simvastatin on Myocardial Protection and Cardiac Function Undergoing Cardiac Surgery With Cardiopulmonary Bypass
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Congenital Heart Disease
Heart Valve Disease
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2012-07-30
Enrollment: 369
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Statins have been used to low cholesterol to prevent and treat coronary artery diseases. It was also reported that statins could protect endothelial function and cardiac function during coronary artery bypass graft. The investigators recent found simvastatin reduced myocardial injury during noncoronary artery cardiac surgery in single medical center. The investigators further investigate that whether simvastatin can protect myocardium during noncoronary artery cardiac surgery with cardiopulmonary bypass and improve cardiac function with long term use postoperatively in two medical centers.


Eligibility criteria: Inclusion Criteria:

* More than 18-year-old,
* Congenital heart disease(not complex),
* Isolated heart valve disease,

Exclusion Criteria:

* Coronary artery disease
* Allergy for statins
* Poor liver function,Hepatitis
* Gestation women and Breast-feeding women

Primary outcomes:
measure: troponin
timeFrame: within the first 7 days after surgery
measure: ejection fraction
timeFrame: within two years
Secondary outcomes:
measure: long term survival
timeFrame: within two years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: The Frist Affiliated Hospital, Sun Yat-sen University
name: Jing-song Ou, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01888523: Stress Management for Cancer Survivors
Official title: Stress Management for Cancer Survivors Using a Technologically Adapted Psychosocial Intervention: A Randomized Trial Determining the Effect of Expressive Writing on Psychoneuroimmunology Based Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Survivors
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2013-06-27
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Determine the efficacy of a brief and inexpensive psychosocial intervention, (called expressive writing) in improving health outcomes for cancer survivors.

Detailed description: This study aims to evaluate a computer-based stress-management therapy called expressive writing. This involves logging in to an online survey and writing in the survey about your thoughts and feelings about your cancer or to type in your everyday experiences. This requires 20-30 minutes of writing a day for 4 consecutive days. You will also provide saliva samples.

Eligibility criteria: Inclusion Criteria:

* have completed their cancer radiation treatment (intent to cure),
* are cancer free, i.e. do not have currently have a diagnosis of primary/secondary cancer or any recurrence/relapse of cancer,
* are in the re-entry phase of cancer survivorship, i.e. 2-12 months post-treatment completion,
* have access to a computer and internet in a private setting, e.g. at home,
* are fluent in English,
* are able to provide informed consent.

Exclusion Criteria:

* patients scheduled to undergo any type of cancer treatment (intent to cure/palliative) in the future (e.g. surgery after completing radiation),
* patients on any kind of corticosteroid medication (e.g. long-term prednisone therapy),
* patients having any condition that affects function of the adrenal glands (e.g. adrenal hyperplasia),
* patients with limited ability to produce saliva, e.g. patients that received radiation (or surgery) on the face region or on salivary glands; or patient's suffering from dry mouth (e.g. Sjögren's syndrome),
* patient's suffering from inflammation of the oral cavity (e.g. gingivitis).

Primary outcomes:
measure: salivary cortisol levels
timeFrame: Up to 6 weeks
Secondary outcomes:
measure: salivary α-amylase and C-Reactive Protein (CRP)
timeFrame: Up to 6 weeks
measure: self-reported psychometric measures
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University/Massey Cancer Center
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Richard Brown, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03088423: HCC Response Assessment by MRI After SBRT
Official title: Tumor Response Assessment by MRI Following Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Hepatocellular
Keywords: MRI
Stereotactic body radiation therapy
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
First posted: 2017-03-23
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients records were extracted from the electronic health record system of Institut de Cancérologie de Lorraine

Brief summary: The aim of this work was to describe SBRT different presentations, to study predictive factors for tumor responses following treatment, and to compare tumor response assessments according to the Response Evaluation Criteria


Eligibility criteria: * Inclusion Criteria: the standard criteria for treating HCC patients with SBRT : an Eastern Cooperative Oncology Group (ECOG) score of 2, inoperable tumors (e.g. the patient being unfit for surgery, or tumor-related contraindications), and a maximum tumor diameter of 6 cm. The HCC diagnosis could be histological or based on the radiological criteria of the American Association for the Study of Liver Diseases (AASLD)
* Exclusion Criteria:no follow-up by MR imaging

Primary outcomes:
measure: tumor response assessments
timeFrame: Within the 24 months after SBRT
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02043223: Stopping Postpartum Vitamin A Supplementation: Missing Concealed Benefit
Official title: Stopping Postpartum Vitamin A Supplementation: Are we Missing Concealed Benefit?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Vitamin A Deficiency
Keywords: Vitamin A
Breast milk
Postpartum vitamin A supplementation
Infant vaccine response
Lead sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
Sponsor class: OTHER
Collaborators: name: Peter Bergman, MD, PhD
name: Karolinska University Hospital
First posted: 2014-01-23
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 32
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the effect of post-partum maternal vitamin A supplementation on breast milk bioactive compounds and immune status, growth and morbidity of children in the first four months of life.

Detailed description: The effect will be assessed by the milk and blood.

Eligibility criteria: Inclusion Criteria:

* Pregnant women \>-18 years of age with low-risk obstetric

Exclusion Criteria:

* Pregnant women expecting a multiple birth
* Take vitamin A supplements during postpartum apart from study intervention
* Premature birth
* Newborn babies with birth defects and / or other serious diseases

Primary outcomes:
measure: Breast milk immune regulators
timeFrame: Four months
Secondary outcomes:
measure: Infant T helper cell immune responses
timeFrame: Four months
measure: Infant innate immune responses
timeFrame: Four months
measure: Infant vaccines (Hepatitis B, Tetanus and Oral polio) specific antibody responses
timeFrame: Four months
measure: Relative abundance of infant gut microbial community and gut inflammatory markers
timeFrame: Four months
Other outcomes:
measure: Infant vitamin A status
timeFrame: Four months
measure: Infant growth
timeFrame: Four months
measure: Infant morbidity
timeFrame: Four months
measure: Mother vitamin A status
timeFrame: Four months
Locations:
city: Dhaka
country: Bangladesh
facility: International Centre for Diarrhoeal Disease Research, Bangladesh
Study officials:
affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Shaikh M Ahmad, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ahmad SM, Hossain MI, Bergman P, Kabir Y, Raqib R. The effect of postpartum vitamin A supplementation on breast milk immune regulators and infant immune functions: study protocol of a randomized, controlled trial. Trials. 2015 Mar 31;16:129. doi: 10.1186/s13063-015-0654-9.
Clinical trial NCT06454123: Feasibility of a Digital Therapeutic for Adults With Binge Eating and Obesity
Official title: A Feasibility Study of a Digital Therapeutic for Adults With Recurrent Binge Eating and Obesity
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Binge Eating
Obesity
Lead sponsor: Oui Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-06-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to test the feasibility of a digital therapeutic to address comorbid binge eating and obesity in adults.

Detailed description: This single-arm, open-label clinical trial will test the feasibility, usability, acceptability, and preliminary efficacy of a digital therapeutic in reducing binge eating and weight in 30 adults with comorbid recurrent binge eating and obesity.

Eligibility criteria: Inclusion Criteria:

1. English speaking male or female patients, 18-70 years
2. Patients with recurrent binge eating (≥12 episodes in 3 months) and obesity (BMI ≥30)
3. Understand written and spoken English
4. Own an iPhone with iOS 11 or higher, or Android with OS 8.1 or higher
5. Willing and able to complete enrollment procedures
6. Able to understand the nature of the study and provide written informed consent

Exclusion Criteria:

1. Patients with active psychosis
2. Patients who are acutely intoxicated at the time of enrollment
3. Currently enrolled in other treatment studies for the symptoms and behaviors targeted
4. Patients who are cognitively impaired
5. Patients who, in the judgment of the investigator, would have an unfavorable risk/benefit profile with respect to the digital therapeutic

Primary outcomes:
measure: System Usability Sale (SUS)
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: