louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00677625: Pediatric Liver Database
Official title: Pediatric Liver Disease and Liver Transplant Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Disease
Liver Transplant
Keywords: Liver
Transplant
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2008-05-14
Enrollment: 401
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: All child subjects will be recruited from the Hepatology Clinic at Children's Hospital of Wisconsin

Brief summary: The purpose of this study is to collect data to examine and characterize the clinical outcomes of pediatric patients diagnosed with any liver disease at Children's Hospital of Wisconsin.

Detailed description: In this study, medical information which is routinely obtained on children with any liver diseases, or children who have had a liver transplant will be entered into a database. No extra tests are done for participating in this study, and no extra visits to the doctor are required. The clinical data collected is then entered into a database and followed longitudinally. The information obtained from this study will help researchers learn more about pediatric liver disease, therefore providing better routine clinical treatment.

Eligibility criteria: Inclusion Criteria:

* Under 18 years of age
* newly diagnosed with a liver disease, currently listed for liver transplant, or who are being considered for liver transplantation and evaluated
* receive a liver transplant prior to their eighteenth birthday

Exclusion Criteria:

* Patients decline participation.
* Patients have no liver diseases.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Grzegorz Telega, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01286025: Comparing the Effect of Video-cases and Text-cases on Medical Students' Learning in Tutorial
Official title: A Randomized Crossover Study to Compare the Critical Thinking of Medical Students When Using Video-based or Written Cases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Education, Medical
Education, Medical, Undergraduate
Problem-based Learning
Problem Solving
Interactive Tutorial
Keywords: medical education
problem-based learning
interactive tutorial
Lead sponsor: Harvard University Faculty of Medicine
Sponsor class: OTHER
First posted: 2011-01-31
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study is designed to examine how the type of learning case affects the thinking of medical students in tutorial

Detailed description: Tutorials at Harvard Medical School use problem-based learning with written cases. Students work in groups under the supervision of a tutor who guides their exploration of the material. As students progress through the curriculum there is an opportunity to advance the complexity of the material they are presented with. Video-based patient case studies have been shown to improve critical thinking ratios in paediatric medical student problem-based learning exercises, and time spent on data exploration, theory building and theory evaluation in postgraduate residency programs. We hypothesize that video provides a stimulus that improves cognitive processing and critical thinking among medical students, as compared to working from the text-based transcript of the same case.

Eligibility criteria: Inclusion Criteria:

* medical student participating in the endocrine and reproductive pathophysiology course at Harvard Medical School

Exclusion Criteria:

* None

Primary outcomes:
measure: Overall ratio of deep to superficial thinking
timeFrame: Four 90-minute tutorial sessions
Secondary outcomes:
measure: Distribution of learning activities
timeFrame: Four 90-min tutorial sessions
measure: Preferences of students for each case modality
timeFrame: 5 weeks
measure: Preferences of tutors for each case modality
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard Medical School
state: Massachusetts
Study officials:
affiliation: Harvard Medical School (HMS and HSDM)
name: Graham T McMahon, MD MMSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02240225: Validation of Chinese SRI Questionnaire
Official title: Validation of Chinese Severe Respiratory Insufficiency （SRI）Questionnaire for COPD Patients With Chronic Hypercapnic Respiratory Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Pulmonary Disease
Hypercapnic Respiratory Failure
Keywords: COPD;SRI;Reliability;validity;
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
Collaborators: name: Southern Medical University, China
name: Second Affiliated Hospital, Sun Yat-Sen University
name: Third Affiliated Hospital, Sun Yat-Sen University
name: Shaoguan People's Hospital
name: Dongguan People's Hospital
name: The center hospital of Wuhan
First posted: 2014-09-15
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult COPD patients with chronic hypercapnic respiratory failure receiving home noninvasive ventilation

Brief summary: Assessment of health-related quality of life in COPD patients with severe chronic respiratory failure requires appropriate and highly specific measurement tools. We attempt to validate the Chinese version of the Severe Respiratory Insufficiency Questionnaire (SRI)


Eligibility criteria: Inclusion Criteria:

1. Adult COPD Patients with chronic hypercapnic respiratory failure established on home noninvasive ventilation for at least 1 month
2. Patients are in a clinically stable state,without any changes of medication during the previous 4 weeks.

Exclusion Criteria:

1. patient's refusal to participate
2. Patients with evidence of acute respiratory failure i.e.patients with worsening of symptoms during the previous 2 weeks, a pH ,7.35, or with signs of respiratory infection

Primary outcomes:
measure: Reliability of Severe Respiratory Insufficiency Questionnaire
timeFrame: 2 weeks
Secondary outcomes:
measure: Construct validity of Severe Respiratory Insufficiency Questionnaire
timeFrame: 2 weeks
measure: Criterion validity of Severe Respiratory Insufficiency Questionnaire
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Institute of Respiratory Disease
state: Guangdong
Study officials:
References:
Clinical trial NCT01726725: Hemifacial Spasm and Desflurane
Official title: Investigating the Etiology of Hemifacial Spasm (HFS): The Role of Desflurane
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemifacial Spasm
Keywords: hemifacial spasm
microvascular decompression surgery
desflurane
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2012-11-15
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with hemifacial spasm who will be undergoing microvascular decompression surgery

Brief summary: Patients are chosen to participate in this study because they will undergo a particular type of brain surgery to treat their hemifacial spasm. This surgery is called microvascular decompression (MVD) and involves the facial nerve. The facial nerve is being compressed by one or more blood vessels and this contact produces the facial twitches. The investigators do not know why a blood vessel that touches the facial nerve produces facial twitches. The investigators are interested in investigating this during your surgery. A total of 25 participants are expected to participate in this study.

Detailed description: "Intra Operative Monitoring" (IOM) is a standard and routine medical practice for patients having MVD surgery. IOM is done to make sure that the hearing and face nerves are not accidentally bumped or damaged during surgery. After anesthetic induction, the neurophysiologist places electrodes for the nerves, on the scalp and muscles. Stimulation and monitoring of muscle twitches are all common, safe and painless medical procedures.

In this study, the investigators would like to measure the nerve and muscle function on the normal side and compare it to nerve and muscle function on the abnormal side during different levels of the anesthetic desflurane. In order to monitor the normal side of the face one additional set of electrodes will be placed in the facial muscles. The investigators will compare responses to three different levels of anesthetic. The technique used will be motor evoked potentials. The effect of the anesthesia on the lateral spread response will also be examined. This response is evident only on the symptomatic side. These observations will take approximately 10 to 15 minutes and will not delay or lengthen the surgery.

Eligibility criteria: Inclusion Criteria:

* patients referred to the neurosurgical service for microvascular decompression surgery for HFS
* males and females 18 to 75 years of age
* otherwise normal neurological exam
* signed informed consent

Exclusion Criteria:

* Botox treatment within the last three months

Primary outcomes:
measure: Measure EMG responses to peripheral nerve stimulation and motor cortex stimulation during changes in desflurane levels
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Manitoba
name: Marshall Wilkinson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06877325: Synergistic Effects of Traditional Chinese Medicine Practices and Pelvic Floor Muscle Training
Official title: Synergistic Effects of Traditional Chinese Medicine Practices and Pelvic Floor Muscle Training on Postpartum Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Stress
Lead sponsor: Guangxi College for Preschool Education
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 108
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was conducted within a randomized controlled trial framework using a double-blind design. Participants were assigned to one of three intervention groups: the Pelvic Floor Muscle Training group (PFMT), the Pelvic Floor Muscle Training combined with the Qigong group (PFMTQG), and the Qigong Practice group (QG). Randomization was performed using a random number table. Professional trainers implemented the intervention programs. Researchers conducted a 12-week intervention study, with training sessions held thrice weekly. During the trial, participants agreed not to engage in other forms of physical exercise.


Eligibility criteria: Inclusion Criteria:

* Aged 20-35 years.
* Within 12 months postpartum.
* Diagnosed with mild to moderate SUI.
* Physically capable of participating in mild to moderate exercise.
* Provided written informed consent.

Exclusion Criteria:

* Severe pelvic floor dysfunction.
* Systemic health conditions that contraindicate physical activity.
* Pregnant at the time of recruitment or planning pregnancy during the study
* Prior structured training in Qigong or PFMT.
* Ongoing physiotherapy for pelvic floor health.
* Participation in other urinary incontinence research.
* Inability to provide informed consent due to cognitive or language barriers.

Primary outcomes:
measure: Incontinence Episode Frequency
timeFrame: Month 3
measure: 1-hour Pad Test
timeFrame: Month 3
Secondary outcomes:
measure: Pelvic Floor Muscle Assessment
timeFrame: Month 3
measure: Incontinence Impact Questionnaire-7
timeFrame: Month 3
measure: Urinary Distress Inventory-6
timeFrame: Month 3
measure: Psychological Well-being Assessment
timeFrame: Month 3
Other outcomes:
Locations:
city: Nanning
country: China
facility: Faculty of Sports Science
state: Guangxi
Study officials:
References:
Clinical trial NCT01390025: Safety Study of Anti-Influenza Virus Monoclonal Antibody to Treat Influenza
Official title: Phase 1 Study of TCN-032 (Human Monoclonal Antibody Directed Against the M2 Protein of Influenza A Virus) in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza, Human
Keywords: Influenza
Monoclonal antibody
Lead sponsor: Theraclone Sciences, Inc.
Sponsor class: INDUSTRY
First posted: 2011-07-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the safety profile in healthy volunteers of a single intravenous administration of TCN-032 as compared with placebo.

Detailed description: Influenza is a highly communicable acute respiratory disease that is considered to be one of the major infectious disease threats to the human population. Annual vaccination is generally effective only against those strains included in the vaccine. Because of the frequent emergence of divergent variants and the periodic emergence of strains with novel hemagglutinin and/or neuraminidase surface proteins that can result in global pandemics, the availability of potent antiviral agents for the prevention and/or treatment of influenza remains an urgent clinical and public health priority.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Normal lab tests

Exclusion Criteria:

* Prior treatment with a monoclonal antibody

Primary outcomes:
measure: Safety assessment - number of participants with adverse events (AE)
timeFrame: 60 days post infusion
Secondary outcomes:
measure: Pharmacokinetic analysis (PK)- Evaluate the single, ascending dose PK of TCN-032
timeFrame: 60 days post infusion
measure: Immunogenicity - detect and measure generation of anti-drug antibodies (ADA)specific for TCN-032
timeFrame: 60 days post infusion
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: SNBL Clinical Pharmacology Center
state: Maryland
Study officials:
affiliation: SNBL
name: Mohamed Al-Ibrahim, MD, FACP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grandea AG 3rd, Olsen OA, Cox TC, Renshaw M, Hammond PW, Chan-Hui PY, Mitcham JL, Cieplak W, Stewart SM, Grantham ML, Pekosz A, Kiso M, Shinya K, Hatta M, Kawaoka Y, Moyle M. Human antibodies reveal a protective epitope that is highly conserved among human and nonhuman influenza A viruses. Proc Natl Acad Sci U S A. 2010 Jul 13;107(28):12658-63. doi: 10.1073/pnas.0911806107. Epub 2010 Jul 1.
Clinical trial NCT00879125: Effect of Gastric Bypass on Patients With Type 2 Diabetes and/or Dyslipidemia
Official title: Effect of Gastric Bypass on Type 2 Diabetes and/or Dyslipidemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Keywords: Gastric by-pass on patients with T2DM
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2009-04-09
Enrollment: 219
Sex: ALL
Minimum age (years): 17
Maximum age (years): 66
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Type 2 diabetes with a BMI over 35kg/m2

Brief summary: This is a retrospective review of patients who have undergone bariatric surgery at VUMC and who have type 2 Diabetes and/or dyslipidemia. The investigators have previously found that gastric bypass significantly improves diabetes 6-12 months after surgery. The investigators are interested in looking at the longer term results after surgery.

Detailed description: Review and record changes in the subject's medication. subjects vitals: weight, blood pressure, and fasting blood values, which include:

* HbA1c
* Fasting blood glucose
* Fasting Insulin
* Lipid Panel ( total cholesterol, LDL, HDL and triglycerides) were obtained.

Eligibility criteria: Inclusion Criteria:

Patients who have had diabetes and/or dyslipidemia prior to gastric by-pass. -

Exclusion Criteria:Patients who have had type 2 diabetes that was diet controlled at time of surgery; and debilitated patients who are unable to come in for a physical exam.

-

Primary outcomes:
measure: glycemic control
timeFrame: one year
Secondary outcomes:
measure: Correction of lipid profiles
timeFrame: one year
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: William O Richards, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01213225: Geriatric Education and Its Effect on Certain Aspects of Hospital Care of the Nursing Home Patients - 12 Month Retrospective Study
Official title: Geriatric Education and Its Effect on Certain Aspects of Hospital Care of the Nursing Home Patients - 12 Month Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frail Elderly
Elderly
Hospitalization
Geriatrics
Keywords: Elderly
Hospitalization
Geriatrics
Mortality
Readmission
Length of Stay
Lead sponsor: Maimonides Medical Center
Sponsor class: OTHER
First posted: 2010-10-01
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 65 years of age and older

Brief summary: Nursing home patients admitted to the hospital poses significant challenge for health care providers. Geriatric teaching pays particular attention to these admissions and related problems. However, it yet to be proven, that geriatric training helps to overcome any of them in better way then non-geriatric education. The study aims to prove that geriatric care provides advantages over non-geriatric training in caring for nursing home patients admitted to the hospital.

Detailed description: Context Nursing home patients admitted to the hospital poses significant challenge for health care providers. Geriatric age, frailty, multiple readmissions, prolonged length of stay, and high mortality are just few attributes of nursing home patients in the hospital. Geriatric teaching pays particular attention to these challenging problems. However, it yet to be proven, that geriatric training helps to overcome any of them in better way then non-geriatric education.

Objective To test the hypothesis that geriatric care provides advantages over non-geriatric training in caring for nursing home patients admitted to the hospital in regards to length of stay, rate of expirations and rate of readmissions. The secondary objective is to compare expirations and readmissions among patients cared for by geriatricians and non-geriatricians.

Design, Setting, and Participants Retrospective cohort study of patients admitted from Metropolitan Jewish Geriatric Nursing Home (MJGNH) to Maimonides Medical Center (MMC) over 12 month period and under the care of geriatricians, non-geriatric internists, and surgeons. Comparison of the three study groups by age, sex, expiration rate, length of hospital stay (LOS) and readmission rate. Comparison of expired patients by age, sex and average LOS. Comparison of readmissions expiration rate, by preservation of continuity of care, by emergency room visits without admission.

Eligibility criteria: Inclusion Criteria:

* all patients admitted to Maimonides Medical Center (MMC) from affiliated Metropolitan Jewish Geriatric Nursing Home (MJGNH)for '12 month period.

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Maimonides Medical Center
name: Sergey I Genkin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01595425: Bioequivalence Study Comparing D961H Sachet and D961H Capsule in Japanese Healthy Male Subjects
Official title: A Phase I, Open-label, Randomized, Single-center, 2-way Crossover Bioequivalence Study Comparing a Pellets Based Sachet Formulation of D961H 20 mg and a Commercial HPMC Capsule of D961H 20 mg After Repeated Oral Administration in Japanese Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioequivalence Study
Keywords: Bioequivalence,
pharmacokinetics,
safety,
esomeprazole,
Japanese,
healthy subject,
homo-EM
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-05-10
Enrollment: 71
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study is to investigate whether D961H sachet 20 mg is bioequivalent to D961H HPMC capsule 20 mg following repeated oral doses, and to evaluate the safety and tolerability of these two formulations in healthy male Japanese subjects.

Detailed description: A Phase I, Open-label, Randomized, Single-center, 2-way Crossover Bioequivalence Study Comparing a Pellets Based Sachet Formulation of D961H 20 mg and a Commercial HPMC Capsule of D961H 20 mg After Repeated Oral Administration in Japanese Healthy Male Subjects

Eligibility criteria: Inclusion Criteria:

1. Provision of signed and dated, written informed consent prior to any study specific procedures
2. Japanese healthy male subjects aged 20 to 45 years of age
3. Body Mass Index 19-27 kg/m2 and body weight 50-85 kg
4. Clinically normal findings
5. Classified as homo-EM(extensive metabolizers) according to the genotype of CYP2C19

Exclusion Criteria:

1. Significant clinical illness
2. Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease
3. Clinical significant condition which could modify the absorption of the investigational product
4. Past or present severe allergic disease, hypersensitivity to food or drugs, or allergic symptoms requiring medical intervention

Primary outcomes:
measure: AUCτ and Cmax,ss of D961H
timeFrame: Day 5
Secondary outcomes:
measure: Profile of pharmacokinetic of D961H in terms of AUC0-t,ss, MRT, tmax,ss, and t1/2.
timeFrame: Day 5
measure: Safety and tolerability of a D961H in terms of clinical laboratory tests, blood pressure, pulse rate and body temperature.
timeFrame: Up to 5 to 7 days after the last dose.
measure: Number of participants with adverse events.
timeFrame: Up to 5 to 7 days after the last dose.
Other outcomes:
Locations:
city: Fukuoka-shi
country: Japan
facility: Research Unit
state: Fukuoka
Study officials:
affiliation: AstraZeneca R&D Japan
name: Masataka Date
role: STUDY_DIRECTOR
affiliation: Hakata Clinic
name: Masanari Shiramoto
role: PRINCIPAL_INVESTIGATOR
References: