louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03509129: Columbia Moves Physical Activity
Official title: Evaluating Columbia Moves: A Social Network Approach Using a Team Competition and Technology to Increase Physical Activity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Physical Activity
Lead sponsor: University of South Carolina
Sponsor class: OTHER
First posted: 2018-04-26
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of adding a team competition comprised of members of existing social networks to a technology-delivered program for enhancing physical activity among insufficiently active adults.

Detailed description: This 3-month randomized controlled trial is designed to investigate the efficacy and feasibility of a novel, technology-oriented physical activity intervention characterized by existing social networks and a team competition. Participants will be recruited via emails, fliers, and word of mouth. They will be randomized to a technology-mediated physical activity treatment (TECH) or a treatment which receives an identical intervention as TECH plus a study designed team competition for physical activity promotion (TECH+COMP).

Eligibility criteria: Inclusion Criteria:

* Insufficiently active as determined by a one-week, accelerometer-based physical activity measurement
* Body mass index (BMI) between 25 kg/m2 and 55 kg/m2
* Between ages 18 and 65 years
* Access to computer with Internet connection
* Smartphone ownership (Android or iOS)
* Willing to be randomized to either one of the two study groups
* Part of a self-selected team of 3-8 eligible individuals
* Members of the same household cannot be part of separate groups
* Able to walk at least 1/4 mile without stopping

Exclusion Criteria:

* Currently lactating, pregnant, or planning to become pregnant during the length of the study
* Diagnosed with type 1 or type 2 diabetes
* Medical or physical contraindications or limitations for engaging in physical activity
* History of major medical or psychiatric conditions
* Currently participating in a physical activity program

Primary outcomes:
measure: Accelerometer-measured change from Baseline Daily Steps at 3 months and 12 months
timeFrame: 0, 3, and 12 months
Secondary outcomes:
measure: Accelerometer-measured change from Baseline Minutes of Moderate-to-Vigorous Physical Activity at 3 months and 12 months
timeFrame: 0, 3, and 12 months
measure: Change from Baseline in Perceived Social Support for Exercise (Sallis Social Support and Exercise Survey) at 3 and 12 months
timeFrame: 0, 3, and 12 months
Other outcomes:
measure: Participant Satisfaction (Satisfaction Questionnaire)
timeFrame: 4 months
Locations:
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
affiliation: University of South Carolina
name: Courtney Monroe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03299829: A Retrospective Study to Assess the Clinical Efficacy and Safety of Trientine in Wilson's Disease Patients
Official title: A Retrospective Study to Assess the Clinical Efficacy and Safety of Trientine in Wilson's Disease Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trientine Treatment for Wilson's Disease
Keywords: trientine
Wilson's disease
Lead sponsor: Excelsior
Sponsor class: INDUSTRY
First posted: 2017-10-03
Enrollment: 48
Sex: ALL
Minimum age (years): 3
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had the diagnosis of Wilson's disease

Brief summary: This is a retrospective study to assess the clinical efficacy and safety of trientine in Wilson's disease patients

Detailed description: In this retrospective study, the investigators will collect and analyze data from reviewing medical history files of larger and long-term follow-up cohorts with Wilson's disease in Taiwan to assess the efficacy and safety of Trientine in Taiwanese Wilson's Disease patients.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Wilson's disease.
* Male or female patients, aged 3 years to 75 years

Exclusion Criteria:

* Patients with comorbidity which is not related to Wilson's disease.

Primary outcomes:
measure: The improvement in liver function
timeFrame: Up to 1 year
Secondary outcomes:
measure: The improvement in urine copper excretion
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital, Linkou
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chinchang Huange, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04840329: Endocation: Trial of an Endometriosis Education Program
Official title: Endocation: A Randomized Cluster Controlled Trial of an Endometriosis Education Program for Middle and Secondary School Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis
Lead sponsor: BC Women's Hospital & Health Centre
Sponsor class: OTHER
Collaborators: name: BC Support Unit
First posted: 2021-04-12
Enrollment: 67
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Endometriosis is a common condition that affects 10% of females, causing chronic pain and other health concerns. Currently, it takes 8-12 years to be diagnosed with endometriosis, in part because there is low awareness of this condition. This research is designed to test whether providing endometriosis education in schools can help increase early awareness of the condition.


Eligibility criteria: Inclusion Criteria:

* 8-12 grade level class

Exclusion Criteria:

* Instruction offered in a language other than English

Primary outcomes:
measure: Change from baseline in menstrual health and endometriosis knowledge
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Change from baseline in prioritization of menstrual health
timeFrame: Baseline and 4 weeks
measure: Change from baseline in confidence in endometriosis knowledge
timeFrame: Baseline and 4 weeks
measure: Change from baseline in comfort with menstrual health
timeFrame: Baseline and 4 weeks
measure: Acceptability of menstrual health and endometriosis education (quantitative)
timeFrame: Immediately following education in intervention and waitlist control group
measure: Acceptability of menstrual health and endometriosis education (qualitative)
timeFrame: Immediately following education in intervention and waitlist control group
measure: Refusal of participants invited to participate
timeFrame: Baseline
measure: Retention of participants
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Women's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Paul Yong
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00166829: The Effect of Sirolimus on the Pharmacokinetics of Tacrolimus
Official title: The Effect of Sirolimus on the Pharmacokinetics of Tacrolimus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Kidney Transplantation
Keywords: Tacrolimus
Sirolimus
Mycophenolic acid
Immunosuppressive Agents
Immunosuppression
Kidney Transplantation
Transplantation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 40
Sex: ALL
Minimum age (years): 13
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to understand whether the pharmacokinetics of tacrolimus is influenced by the concurrent use of sirolimus.

Detailed description: The controlled clinical trial held in NTUH in 2001 revealed that the bioavailability of tacrolimus when combined with sirolimus is lower than that reported in the literature where tacrolimus was not combined with sirolimus. To determine if the difference was due to the drug interaction between sirolimus and tacrolimus, a controlled clinical trial was proposed.

The purpose of this study is to understand whether the pharmacokinetics of tacrolimus is influenced by the concurrent use of sirolimus.

Eligibility criteria: Inclusion Criteria:

* De novo kidney transplant patients
* Aged 13 - 65 years
* Having aminotransferase concentrations within 2 times the upper limit of normal

Exclusion Criteria:

* Pregnancy
* Tuberculosis
* Hepatitis B or C carrier status
* Human immunodeficiency virus-positive status
* Retransplantation or multi-organ transplantation
* History of rheumatoid arthritis

Primary outcomes:
measure: The influence of sirolimus on the pharmacokinetics of tacrolimus in renal transplant patients
Secondary outcomes:
measure: Compare the outcome of tacrolimus/sirolimus and tacrolimus/mycophenolate in rejection prevention
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Po-Huang Lee, MD, PhD
role: STUDY_CHAIR
References:
citation: Tsai MK, Wu FL, Lai IR, Lee CY, Hu RH, Lee PH. Decreased acute rejection and improved renal allograft survival using sirolimus and low-dose calcineurin inhibitors without induction therapy. Int J Artif Organs. 2009 Jun;32(6):371-80. doi: 10.1177/039139880903200608.
Clinical trial NCT02236429: Vaginal Flora for Treatment of Bacterial Vaginosis
Official title: Vaginal Flora Transplantation for Recurrent Bacterial Vaginosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Recurrent Bacterial Vaginitis
Keywords: bacterial vaginitis
vaginal flora
microbiome
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2014-09-10
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Bacterial vaginosis (BV) is the most common vaginal infection in women. It is caused by a vaginal bacterial imbalance. Treatment with antibiotics is the standard of care but there is a high rate of recurrence. Almost half of women successfully treated suffer a recurrence within three months. Complications include risk factors for premature birth, increased transmission of sexually transmitted diseases and higher risk for carcinoma of cervix. The investigators proposed study is a cost effective treatment based on returning the normal microbial balance to the vagina. The investigators propose to transfer normal vaginal flora from healthy individuals to women with BV and thus restore normal vaginal flora and cure this disorder.


Eligibility criteria: Inclusion Criteria:

* recurrent BV (4 or more incidences in the past year)
* recurrence of BV in less than 2 months of antibiotic treatment or need for prophylactic antibiotic
* 3/4 Amsel criteria and Nugent criteria greater or equal to 7

Exclusion Criteria:

* pregnancy or planned pregnancy during the study period
* other known diseases
* carriers of Hep B and C
* HIV or syphilis positive

Primary outcomes:
measure: relief of bacterial vaginosis
timeFrame: 12 month
Secondary outcomes:
measure: Laboratory parameters
timeFrame: 12 months
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Mediocal Organization
name: Ahinoam Lev-Sagie, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lev-Sagie A, Goldman-Wohl D, Cohen Y, Dori-Bachash M, Leshem A, Mor U, Strahilevitz J, Moses AE, Shapiro H, Yagel S, Elinav E. Vaginal microbiome transplantation in women with intractable bacterial vaginosis. Nat Med. 2019 Oct;25(10):1500-1504. doi: 10.1038/s41591-019-0600-6. Epub 2019 Oct 7.
Clinical trial NCT06148129: Immunohistochemistry Role in Better Prognosis of Endometrial Carcinoma Patients
Official title: Stratification of Endometrial Carcinoma Patients Using Immunohistochemistry for Better Surgical Planning and Prognosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Cancer
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2023-11-28
Enrollment: 96
Sex: FEMALE
Minimum age (years): 36
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The incidence of endometrial cancer (EC) is increasing .Different risk classifications are used to direct the primary and adjuvant therapy. The European Society for Medical Oncology - European Society of Gynaecological Oncology -European Society for Radiotherapy \& Oncology (ESMO-ESGO- ESTRO) could guide the need for lymph node surgery pre-operatively, and also post-operatively to determine adjuvant treatment.

Low-risk patients are managed with surgery alone, while higher-risk group patients undergo more aggressive surgical options. So, it is important to identify new prognostic markers for better stratification of patients to avoid under- or over treatment of EC patients.


Eligibility criteria: Inclusion Criteria:

* aged 36 -72 years;
* Previously diagnosed with endometrial carcinoma;
* Histological Type of the tumor;
* Myometrial Invasion;
* lymph Node Invasion;
* Cervical Invasion;
* Biomarkers expression.

Exclusion Criteria:

* Lack of tumor tissue in tissue block

Primary outcomes:
measure: expression levels of p53/L1CAM/ER/PR
timeFrame: 36 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig university
state: Ash Sharqia Governorate
Study officials:
References:
Clinical trial NCT02690129: Vaginal Progesterone for Treatment of Threatened Miscarriage
Official title: Vaginal Progesterone for Treatment of Threatened Miscarriage; Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Threatened Miscarriage
Keywords: progesterone
threatened abortion
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-02-24
Enrollment: 290
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: The purpose of the study is to assess the efficacy of vaginal micronized progesterone in the treatment of threatened miscarriage. All eligible pregnant women will be randomized to either receive vaginal progesterone or no treatment.Evaluation will be two weeks after intervention, then every 4 weeks up to 28 weeks gestation or termination of pregnancy.


Eligibility criteria: Inclusion Criteria:

1. Pregnant with gestational age less than 24 weeks
2. Presented by bleeding with or without pain
3. Single viable fetus (confirmed by Ultrasound examination)
4. Accepting to have vaginal medication

Exclusion Criteria:

1. Currently under medication for any chronic diseases (DM, thyroid, liver, renal, cardiac and autoimmune disease).
2. Hypersensitivity to progesterone
3. Any documented congenital fetal anomaly in the current pregnancy
4. Women received hormonal treatment in the current pregnancy
5. Patients conceived via ART

Primary outcomes:
measure: Miscarriage rate up to 28 weeks of gestation
timeFrame: Completed 28th week
Secondary outcomes:
measure: Gestational age at delivery or termination of pregnancy
timeFrame: Number of completed weeks at the time of delivery
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine
Study officials:
References:
Clinical trial NCT06750029: How Does Medical Clown Intervention Affect the Length of Hospitalization in Children With Pneumonia
Official title: How Does Medical Clown Intervention Affect the Length of Hospitalization in Children With Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Community-Acquired Pneumonia (CAP)
Keywords: Medical clowns
Community-Acquired Pneumonia (CAP)
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 51
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background and Objectives: Community-acquired pneumonia (CAP) is a leading cause of hospitalization in children. The hospitalization duration depends on factors as child's well-being, vital signs, need for parenteral treatments, and development of complications. Medical clowns (MCs) are known to assist in reducing pain and alleviating anxiety and have been integrated into many aspects of hospital treatment routines. The aim of this study is to evaluate the effect of MC intervention on length of hospitalization in children admitted with CAP.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of pneumonia.
* Ages 2-18 years.

Exclusion Criteria:

* Hemodynamically unstable patients.
* Other systemic comorbidities or chronic respiratory diseases
* Children from families unable to comprehend and sign an informed consent form.

Primary outcomes:
measure: The length of hospitalization in hours
timeFrame: Immediately after the intervention
Secondary outcomes:
measure: Duration of IV treatment
timeFrame: Immediately after the intervention
Other outcomes:
measure: Changes in well-being scores as reported by both the parent and the treating physician.
timeFrame: Immediately after the intervention
measure: Alterations in Heart rate
timeFrame: Immediately after the intervention
measure: Alterations in body temperature
timeFrame: Immediately after the intervention
measure: Alterations in Respiratory rate
timeFrame: Immediately after the intervention
measure: Alterations in oxygen saturation
timeFrame: Immediately after the intervention
measure: Alterations in white blood cell count
timeFrame: Immediately after the intervention
measure: Alterations in absolute neutrophil count
timeFrame: Immediately after the intervention
measure: Alterations in C-reactive protein levels
timeFrame: Immediately after the intervention
Locations:
city: Haifa
country: Israel
facility: Carmel Medical Center
Study officials:
References:
Clinical trial NCT05710029: Cortical Processes During Walking Post-stroke
Official title: Cortical Processes During Walking Post-stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Acute
Walking, Difficulty
Keywords: Walking
Stroke
EEG
Assistance
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post-stroke participants (age 18-80), age-matched adults (age 18-80)

Brief summary: The study aims to use novel mobile imaging techniques with high-density electroencephalography (EEG) to quantify cortical processes synchronized to the biomechanics of walking. Here, the study has two aims - the primary aim is to quantify the cortical processes that contribute to gait dysfunction early post-stroke, and the second aim is to determine how cortical processes are mediated by mechanical assistance during early gait training post-stroke.

Participants will wear an electroencephalography (EEG) cap to measure brain activity and other non-invasive physiological sensors. Participants will be asked to perform different tasks, such as walking at different speeds and walking with different levels of body weight support.

Detailed description: This study will recruit 15 subacute post-stroke individuals and 15 age-matched neurotypical individuals between the age of 18-80 years old.

Eligibility criteria: Inclusion Criteria for post-stroke patients:

* Participants will have a unilateral brain lesion within six months prior to participation in this project;
* Paresis confined to one side;
* Ability to walk for 10 meters continuously;
* Absence of severe cognitive dysfunction as demonstrated by a Mini-Mental score greater than 24;
* Absence of severe concurrent medical problems;
* Ability to provide informed consent.

Exclusion Criteria for age-matched adults:

* Any major neurological, cardiovascular, orthopedic, and psychiatric diagnoses

Primary outcomes:
measure: Brain activity during walking measured by EEG
timeFrame: through study study completion, an average of 2 years
measure: Brain activity during walking measured by EEG
timeFrame: through study study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Chang Liu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Daniel Ferris, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Dorian Rose, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: