louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06422559: Accelerated Intermittent Theta Burst Stimulation in Unipolar Versus Bipolar Depression
Official title: Accelerated Intermittent Theta Burst Stimulation in Unipolar Versus Bipolar Depression
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depressive Disorder
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-05-21
Enrollment: 60
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 goal of this interventional study is to learn if accelerated Intermittent Theta Burst Stimulation can improve symptoms of 30 participants with Unipolar depression in higher manner than symptoms of 30 participants with bipolar depression

Detailed description: We will apply stimulatory TMS protocol for participants with Unipolar depression and participants with bipolar depression using MagVenture MagPro R30 stimulator with the Cool-B65 coil

Eligibility criteria: Inclusion Criteria:

* Age:18_65 years
* Sex:male and female
* Patients with Unipolar depression and bipolar depression diagnosis confirmed by SCID according to DSM5
* No pharmacological change in the last 4 weeks before the beginning of the stimulantion cycle
* Pharmacological resistance

Exclusion Criteria:

* Patients complaining of psychosis.Substance Use Disorder.current suicidal ideation.major medical and neurological disorder
* Patients complaining of epilepsy
* pregnancy and breastfeeding
* peacemaker spinal or bladder stimulator
* History of skull surgery and trauma
* presence of metallic foreign body

Primary outcomes:
measure: Comparison of severity of manic symptoms before and after treatment
timeFrame: One year for completion of the study
measure: Comparison of the severity of the patient's illness at the time of assessment relative to the clinician's past experience with patients who have the same diagnosis.
timeFrame: One year for completion of the study
measure: Comparison of severity and impact of insomnia before and after treatment
timeFrame: One year for completion of the study
measure: Comparison of depressive symptoms before and after treatment
timeFrame: One year for completion of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
Study officials:
affiliation: Professor
name: Hala A. El-boraie
role: STUDY_CHAIR
affiliation: Assistant professor
name: Ibrahim H. Rashed
role: STUDY_DIRECTOR
affiliation: Lecturer
name: Hassan M. Sonbol
role: STUDY_DIRECTOR
References:
citation: Chang J, Chu Y, Ren Y, Li C, Wang Y, Chu XP. Maintenance treatment of transcranial magnetic stimulation (TMS) for treatment-resistant depression patients responding to acute TMS treatment. Int J Physiol Pathophysiol Pharmacol. 2020 Oct 15;12(5):128-133. eCollection 2020.
Clinical trial NCT04190459: Quality of Life 10 Years After Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2019-12-09
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Initially the investigators included 65 patients undergoing surgical treatment for morbid obesity \[39 females (60%) and 26 males (40%)\]. Mean age was 42.75 years. Overall, 34 patients underwent LSG (52.3%) and 31 patients underwent LRYGB (47.7%). Mean initial body weight was 146.2 kg, mean BMI before surgery was 50.44 kg/m2.

Brief summary: Importance: Improvement of the QoL after bariatric surgery is an important outcome of the treatment. The investigators believe that assessment of distant QoL results, could provide new insight into effectiveness of most popular bariatric procedures.

Objective: The investigators aim to analyze the bariatric surgery effect on the long term QoL, considering the type of surgery.

Design: A cohort study including patients undergoing bariatric surgery. Setting: One academic referral center. Exposures: Patients undergo Laparoscopic Sleeve Gastrectomy or Laparoscopic Roux-en-Y Gastric Bypass . Surgical technique is standardized and consistent in the whole study group.

Main Outcomes and Measures: The main outcome is the change of QoL after bariatric surgery. It is assessed in three different time points: pre-surgery, first follow up (1 year after surgery) and second follow-up (10 years after surgery). The investigators use two licensed and standardized questionnaires: (Short Form Health Survey) and MA-QoLQII (Moorehead-Ardelt Quality of Life Questionnaire II).


Eligibility criteria: Inclusion Criteria:

* informed consent to participate in the study
* meeting the eligibility criteria for bariatric treatment, either for laparoscopic sleeve gastrectomy (LSG) or laparoscopic Roux-en-Y gastric bypass (LRYGB).

Exclusion Criteria:

* previous bariatric procedures

Primary outcomes:
measure: Quality of life measured as a Short Form Health Survey - 36 score.
timeFrame: 10 years
measure: Quality of life measured as a Moorehead-Ardelt Quality of Life Questionnaire II score.
timeFrame: 10 years
Secondary outcomes:
measure: Weight change
timeFrame: 10 years
Other outcomes:
Locations:
city: Cracovia
country: Poland
facility: 2nd Department of General Surgery, Jagiellonian University Medical College
Study officials:
References:
Clinical trial NCT01153659: A Study to Evaluate the Effect on 24-hour, Intragastric pH of RAB ER 50-mg Capsules Compared With Esomeprazole (Nexium) 40 mg Capsules and Rabeprazole (Aciphex) 20-mg Tablets
Official title: A Randomized, Open-Label, Three-Way Crossover Study to Evaluate the Effect on 24-hour, Intragastric pH Following Daily Oral Dose Administration of RAB ER 50-mg Capsules Compared With Esomeprazole (Nexium) 40-mg Capsules and Rabeprazole (Aciphex) 20-mg Tablets to H. Pylori-Negative Healthy Subjects in a 5-day Treatment Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: rabeprazole
esomeprazole
h. pylori-negative
nocturnal acid breakthrough
intragastric pH, PK/PD
effect on gastric pH in healthy, H. pylori-Negative subjects
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2010-06-30
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This will be a randomized, open-label, single-center, 3-way crossover study in healthy subjects who are confirmed to be Helicobacter pylori (H. pylori)-negative. The study will consist of 3 study periods separated by a washout period of at least 7 days. Subjects will receive study drugs once daily for 5 days. Barring any safety concerns, subjects will be discharged from the study on Day 6 of Period 3 after completion of discharge procedures.


Eligibility criteria: Key inclusion:

* Healthy male and female subjects, including women of child-bearing potential, aged 18 to 55 years, inclusive
* Subjects who are able to tolerate the insertion and placement of a pH probe on 2 occasions per study period (Day -1 and Day 5)

Key Exclusion:

* Subjects who are H. pylori-positive
* Subjects who have a history of any gastrointestinal disorder or surgery likely to influence drug absorption (e.g., history of gastric resection)
* Known hypersensitivity to rabeprazole, esomeprazole, or related compounds or any ingredient in the formulations
* Other standard clinical pharmacology exclusion criteria for healthy volunteers

Primary outcomes:
measure: Percentage of time that intragastric pH remains >4
timeFrame: 24-hr period post-dose on Day 5
Secondary outcomes:
measure: Percentage of day- and night-time periods with intragastric pH >4
timeFrame: Days 1 and 5
measure: Number and duration of nocturnal acid breakthrough (NAB) episodes
timeFrame: Days 1 and 5
measure: Proportion of subjects with nocturnal acid breakthrough (NAB) episodes
timeFrame: Days 1 and 5
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Oklahoma Foundation for Digestive Research
state: Oklahoma
Study officials:
affiliation: Oklahoma Foundation for Digestive Research, 1000 N. Lincoln, Suite 210, Oklahoma City, OK 73104 USA
name: Philip Miner
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06235359: Is Intercostal Tube Enough in Management of Empyema
Official title: Is Intercostal Tube Enough in Management of Empyema
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Empyema
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Is intercostal tube enough in management of empyema ?

Detailed description: Empyema refers to presence of pus in the pleural space -Causes Primary: bacterial Pneumonia (staph aureus, strept pneumonia , H.influenza) , TB

Secondry :

PostTraumati postoperative :open heart , esophageal, mediastinum , lung rupture of lung absess

-pathophysiology and stages During an inflammatory process such as pneumonia, there is an increase in fluid production in the pleural cavity known as the exudate stage. As the disease progresses microorganisms, usually bacteria, can colonize the fluid and generated an empyema. This fluid is characterized by elevated lactate dehydrogenase, proteins, neutrophils, and dead cells. Macroscopically is a thick opaque fluid found in the fibrinopurulent stage. After the resolution of the infection and as a consequence of the inflammation, there is a process of fibrosis that can lead to restriction of the lung parenchyma which is stage of chronic organization

Eligibility criteria: Inclusion Criteria:

* patients admitted to Assuit university Hospital and diagnosed with empyema

Exclusion Criteria:

* Patient diagnosed with Post-operative empyema
* Patient diagnosed with post traumatic empyema
* Patient diagnosed with Bronchopleural fistula
* Patient diagnosed with TB

Primary outcomes:
measure: To find best way to drain the pus in the pleural space
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Ali I, Unruh H. Management of empyema thoracis. Ann Thorac Surg. 1990 Sep;50(3):355-9. doi: 10.1016/0003-4975(90)90474-k.
Clinical trial NCT03647059: Rapid Assessment of Donor Liver Quality
Official title: Real-time Noninvasive Assessment of Donor Liver Quality
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Transplant; Failure, Liver
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2018-08-27
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All donor livers to be used for liver transplantations. Before transplant, the donor liver will be stored in the cold-UW solution in ice water. We just cut a piece of liver simple in the any place of donor liver, usually, we always cut a piece of liver simple from the edge of the donor liver.

Brief summary: Aims：

1. Conduct multi-center, prospective and open research on liver quality assessment and establish LSCM liver quality assessment system
2. Classification of liver quality grades by LSCM for different pathological conditions (steatosis, fibrosis, hepatocyte necrosis, etc.)
3. Compare the specificity and sensitivity of LSCM evaluation results with the results of liver donor quality evaluation and intraoperative pathological biopsy results.
4. LSCM classifies the quality of donor liver and compares the recovery of liver function on the first day after liver transplantation.
5. LSCM grades the quality of donor liver and compares the long-term prognosis


Eligibility criteria: Inclusion Criteria:

* All donor livers to be used for liver transplantations

Exclusion Criteria:

* Exclusion of multiple organ transplantation
* Exclusion of detached transplantation and partial liver transplantation, etc.
* Removal of blood type incompatible patients for transplantation
* Exclusion of poor donor liver quality due to surgical technique (such as hepatic artery embolization) , portal vein thrombosis, etc.)
* Any form of substance abuse, mental illness or any disease that the investigator believes may interfere with the patient's understanding of the research requirements.
* Can not complete routine research follow-up, and other circumstances that the investigator believes are not suitable for the experiment.

Primary outcomes:
measure: LSCM examination results
timeFrame: 1 day
Secondary outcomes:
measure: HE section staining pathological examination
timeFrame: 1 week
Other outcomes:
measure: Clinical examinations
timeFrame: 1 week
Locations:
city: Shanghai
country: China
facility: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
name: Zhong Lin, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06087159: Promoting Mental Health of Teachers and Caregiver Using a Personalized mHealth Toolkit in Uganda
Official title: Promoting Mental Health of Teachers and Caregivers Using a Personalized mHealth Toolkit in Uganda
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health Literacy
Depression, Anxiety
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-10-17
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized controlled trial with 8 schools (4 intervention and 4 wait-list control schools) including 160 caregivers (80 teachers and 80 parents), with the aim of pilot testing the implementation process, feasibility, acceptability, usage patterns, and efficacy of the mHealth Toolkit for Wellness \& Empowering Lives of School Community (mWEL) in Uganda. The mWEL-App is a preventive intervention tool for teachers and parents as a self-help support modality. Caregivers who need support in navigating the toolkit will be supported by P-CHWs. The investigators hypothesize that: 1) relative to the control, caregivers receiving the mWEL will have better efficacy outcomes (mental health literacy, and mental health outcomes); and 2) mWEL implementation will have high acceptability, appropriateness, and feasibility.


Eligibility criteria: Teachers Inclusion Criteria:

* Teaching in recruited schools.
* At least 18 years old.

Parents Inclusion Criteria:

* At least 18 years old.
* Have a child aged 6-14 years.

Exclusion Criteria:

* Evidence of psychopathology or cognitive impairment severe enough to preclude giving consent, or completing the survey instruments or the focus group of the study.
* Parents/Teachers/Caregivers who are not in one of our recruited primary school
* Participants under the age of 18
* Participant who does not speak English and Luganda will not be able to participate

Primary outcomes:
measure: Change in Universal Mental Health Literacy Scale Score
timeFrame: Baseline, Month 5
measure: Change in PHQ-9 Score
timeFrame: Baseline, Month 5
measure: Change in GAD-7 Anxiety Score
timeFrame: Baseline, Month 5
Secondary outcomes:
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Study Site
city: Nakaseke
country: Uganda
facility: Study Site
Study officials:
affiliation: NYU Langone Health
name: Keng-Yen Huang, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03205059: An Evidence-based Approach for Bullying Prevention
Official title: An Evidence-based Approach for Bullying Prevention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bullying
Cyberbullying
Substance Use
Substance Abuse
Lead sponsor: National Health Promotion Associates, Inc.
Sponsor class: INDUSTRY
First posted: 2017-07-02
Enrollment: 3000
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This Phase II SBIR project is designed to address the critical public health problem of bullying and cyberbullying among middle school age youth. The project involves developing and testing bullying and cyberbullying prevention materials, including interactive classroom sessions and corresponding serious games, based on the evidence-based substance abuse prevention approach called Life Skills Training. The product has the potential to fill a gap in the intervention tools currently available to schools that can be widely disseminated throughout the country using existing marketing and dissemination channels and decrease the adverse consequences of bullying and cyberbullying as well as substance abuse.


Eligibility criteria: Inclusion Criteria:

* Middle school aged-youth

Exclusion Criteria:

* Significant cognitive impairment or severe learning disabilities, as screened by field staff at participating sites

Primary outcomes:
measure: Change in bullying/cyberbullying perpetration in the past two years
timeFrame: Post-test (within 2 weeks of completing final session/module of the intervention), 12-month follow-up, 24-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: White Plains
country: United States
facility: National Health Promotion Associates
state: New York
Study officials:
References:
Clinical trial NCT03179059: Resolution of Uncertainty Through Testing
Official title: Resolution of Uncertainty Through Testing: The Impact of Pregnancy Tests on Reproductive and Maternal Health Beliefs and Behaviors in Uganda
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pregnancy Tests
Keywords: Reproductive Health
Family Planning
Randomization Trial
Uganda
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: Mbarara University of Science and Technology
name: Ichuli Consulting Limited
First posted: 2017-06-07
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Given the high rate of delayed adoption of antenatal care (ANC), and high rates of unintended pregnancy and unsafe abortion in Uganda, research on the period of time before confirmation of pregnancy is critical to understand underlying beliefs that guide behaviors ultimately important for maternal and neonatal health (UDHS, 2011; Hussain, 2013).

Home pregnancy tests - which now cost less than 10 cents each - have the potential to facilitate FP uptake and significantly improve reproductive, maternal and child health outcomes in sub-Saharan Africa, including Uganda. These tests are easy to administer, disposable, inexpensive, and have a low false positive rate. Yet, for women living in rural areas in sub-Saharan countries, these tests are typically unavailable outside of health centers or they are prohibitively expensive.

This study will investigate women's underlying beliefs about pregnancy status and examine how providing access to home-based pregnancy tests - thus facilitating earlier resolution of uncertainty of pregnancy status - influences such beliefs and decisions to take up family planning (FP) or seek appropriate pregnancy services.

The results will inform the design of a larger study in the future.


Eligibility criteria: Inclusion Criteria:

* Between the ages of 18-35
* Live in the catchment area

Exclusion Criteria:

- Currently attending school

End Survey if

* Women in menopause
* Women with sterilization
* Women with husband/partner with sterilization
* Women who do not understand what menstrual period is

Primary outcomes:
measure: Binary measures for the family planning take up
timeFrame: At end line survey, half a year after intervention
Secondary outcomes:
measure: Binary measure of purchase of pregnancy test kit by price
timeFrame: At end line survey, half a year after intervention
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Ichuli Institute
Study officials:
References:
Clinical trial NCT00146159: Study Evaluating Mitoxantrone in Multiple Sclerosis
Official title: A Double-Blind, Three-Armed, Randomized Phase-III-Study, to Compare the Efficacy, Tolerability and Safety of Three Doses of Mitoxantrone in the Treatment of Patients With Secondary Progressive Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Secondary Progressive Multiple Sclerosis
Keywords: Multiple Sclerosis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-05
Enrollment: 336
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to show the dose-response relationship of three doses of mitoxantrone with regard to efficacy in patients with secondary progressive multiple sclerosis and to show the safety and tolerability of mitoxantrone in these patients.


Eligibility criteria: Inclusion Criteria:

* Secondary progressive MS in an active stage
* EDSS between 3 and 6

Exclusion Criteria:

* Benign or primary progressive MS
* Patients with cardiac risk factors
* Patients who have already received mitoxantrone

Primary outcomes:
measure: 3 clinical measures combined in a multivariate analysis: confirmed Expanded Disability Status Scale(EDSS)
timeFrame: 3 years
measure: deterioration, change of ambulation index, time to first relapse requiring corticoid treatment
timeFrame: 3 years
Secondary outcomes:
measure: derivations of EDSS and relapses; MRI (baseline, 2 years)
timeFrame: 3 years
Other outcomes:
Locations:
city: Berg
country: Germany
city: Berlin
country: Germany
city: Düsseldorf
country: Germany
city: Düsseldorf
country: Germany
city: Gießen
country: Germany
city: Marburg
country: Germany
city: Wiesbaden
country: Germany
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: