louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03680950: Efficacy Test of Real-Time Upper Gastrointestinal Monitoring System
Official title: Efficacy Test of Real-Time Upper Gastrointestinal Monitoring System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Gastrointestinal Bleeding
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2018-09-21
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A monitoring system was developed for detecting upper gastrointestinal (UGI) rebleeding. This system consists of (1) a tiny endoscopy, (2) a wearable device, and (3) a software. The endoscopy is inserted to UGI tract via nasal cavity and then stayed there for 3 days. The wearable device is set to regularly receive the pictures from the endoscopy and sent to the software, which is able to automatically analyze whether the rebleeding occurs. This study aims to test the feasibility and efficacy of the monitoring system.


Eligibility criteria: Inclusion Criteria:

* "Rockall" score ≧3

Exclusion Criteria:

* Pregnant woman;
* Behavioral disorder;
* Major cognitive-perceptual deficit;
* The person who has a nasogastric (NG) tube;
* Other deficits or disorders that are not suitable for NG insertion;
* Participants who need to take MRI scan.

Primary outcomes:
measure: Time to detection of upper gastrointestinal rebleeding between the upper gastrointestinal monitoring system vs. the current monitoring index.
timeFrame: 3 days
Secondary outcomes:
measure: The accuracy of upper gastrointestinal rebleeding detection between the upper gastrointestinal monitoring system vs. the current monitoring index.
timeFrame: 3 days
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
References:
Clinical trial NCT05078450: Mood Lifters Online for Graduate Students and Young Professionals
Official title: Mood Lifters Online
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety Disorders
Mood Disorders
Mental Illness
Stress
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2021-10-14
Enrollment: 362
Sex: ALL
Minimum age (years): 22
Maximum age (years): 32
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Mood Lifters is a revolutionary mental wellness program that teaches scientifically validated strategies in a supportive group setting. This study will test two new versions of the program designed specifically for graduate students and young professionals.

Participants will need to attend 12 hour long virtual weekly meetings on Zoom that focus on helpful mental health strategies and skills. Participants will be encourage to practice what the participants learn at home in order to improve their mood or mental wellness. Additionally, participants will complete a series of measures (approx. 1-1.5 hours) prior to, at the end of the program, 1 month after the program and 6 months after the program.


Eligibility criteria: Inclusion Criteria:

* Participants ages 22-32 (must identify as either a graduate student or a young professional)

Exclusion Criteria:

* Active suicidality, mania, or psychosis

Primary outcomes:
measure: Patient Health Questionnaire - 9
timeFrame: through study completion, an average of 1 year
measure: Generalized Anxiety Disorder - 7
timeFrame: through study completion, an average of 1 year
measure: Perceived Stress Scale
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References:
citation: Garg T, Votta CM, Prakash N, Deldin PJ. An investigation into the effectiveness of Mood Lifters in the context of trauma exposure. Psychol Serv. 2024 Aug;21(3):518-528. doi: 10.1037/ser0000789. Epub 2023 Aug 24.
citation: Pokowitz EL, Prakash N, Planaj D, Oprandi S, Deldin PJ. Mood Lifters for Graduate Students and Young Adults: A Mixed-Methods Investigation into Mechanisms of Change in Online Group Therapy. Behav Sci (Basel). 2024 Mar 20;14(3):252. doi: 10.3390/bs14030252.
citation: Prakash N, Votta CM, Deldin PJ. Treatment for graduate students: Blunting the emotional toll of postgraduate education. J Consult Clin Psychol. 2023 Dec;91(12):708-716. doi: 10.1037/ccp0000844. Epub 2023 Sep 21.
Clinical trial NCT00209950: A Prospective Open-Label Extension Study of Gaboxadol in Primary Insomnia
Official title: A Prospective Open-Label Extension Study (to Study 99784) of Gaboxadol in Primary Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Insomnia
Keywords: Primary insomnia
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and tolerability of gaboxadol in primary insomnia

Detailed description: To evaluate long-term safety of gaboxadol in healthy adults.

Eligibility criteria: Inclusion Criteria:

* patients with a diagnosis of primary insomnia

Primary outcomes:
measure: Safety
measure: Tolerability
Secondary outcomes:
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: Non-US study, principal location:
Study officials:
affiliation: H. Lundbeck A/S
name: Please contact: Annelies van der Hammen Legters
role: STUDY_DIRECTOR
References:
Clinical trial NCT03530150: Pirfenidone and Its Role in Burn Wound Healing
Official title: Pirfenidone and Its Efficacy in Wound Re-Epithelization in Patients With Second-Degree Burns: A Proof-of-Concept Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Second-degree Burn
Keywords: Burns
Partial-thickness burn wounds
Re-epithelization
Second-Degree Wound
Pirfenidone
Wound Healing
Lead sponsor: Universidad Autonoma de Nuevo Leon
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Burn patients will be divided to receive either 600 mg of pirfenidone or usual care
Primary purpose: TREATMENT

Brief summary: Burn patients which skin has been lost a rapid growth of the skin is a foremost in their treatment. Due to the injury, burn patients undergo a systemic inflammation that helps the skin heal faster. However, several studies have shown that this inflammation increases the levels of several inflammatory molecules that impairs skin growing, which further delays the recovery of burn patients. As such, by inhibiting these inflammatory molecules with the administration of a medication called pirfenidone burn patients might present faster rates of skin growth and recovery. Thus, patients suffering from a burn injury will be recruited at the emergency department of the Hospital University in Monterrey Mexico. Afterward, patients will be randomized to either receive pirfenidone 600 mg orally once per day or usual care consisting of covering the wound with hydrocolloid dressings. To assess the amount of newly growth skin investigators will take a small piece of the skin to further evaluate it through a microscope.


Eligibility criteria: Inclusion Criteria:

* Patients with second-degree burns from any etiology with less than 24 hours of evolution.

Exclusion Criteria:

* Patients \<18 years old
* Patients allergic to pirfenidone
* Pregnant patients
* Patients with renal or hepatic failure
* Patients who are not able to take the medication orally
* Conditions or drugs that alter wound healing (i.e. any kind of diabetes, lupus, having a history of using steroids, rheumatoid arthritis)

Primary outcomes:
measure: Epidermal re-epithelization
timeFrame: Day 7
Secondary outcomes:
measure: Presence of Fibrosis
timeFrame: Day 0 and 7
measure: Basal Membrane Integrity
timeFrame: Day 0 and 7
measure: Presence of Collagen Fibers
timeFrame: Day 0 and 7
measure: Clinical Evaluations of Wound's Re-Epithelization
timeFrame: Day 7
Other outcomes:
Locations:
Study officials:
affiliation: Universidad Autonoma de Nuevo Leon
name: Gabriel A Mecott-Rivera, MMS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02203955: Study of Sc-FOS for Pouchitis Prevention
Official title: Prevention of Pouchitis With Short-Chain Fructooligosaccharide Therapy, A Double-Blind, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pouchitis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2014-07-30
Enrollment: 13
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: PREVENTION

Brief summary: The main objective is to compare prebiotic therapy with placebo for the prevention of pouchitis after closure of diverting ileostomy in patients with an ileal pouch anal anastomosis. This study will also characterize the effects of prebiotics on the fecal microbiota and fecal microbial metabolites and correlate these effects with the primary outcome of development of pouchitis.


Eligibility criteria: Inclusion criteria:

1. Age 18-65 years.
2. History of ulcerative colitis
3. Ileostomy closure after IPAA
4. Ability to give appropriate consent

Exclusion Criteria:

1. Crohn's disease.
2. Perianal disease (including abscess, fissure, or stricture)
3. Pregnancy
4. Lactation
5. Concurrent treatment for IBD or pouchitis

Primary outcomes:
measure: Mean Change in Pouchitis Disease Activity Index (PDAI) at One Year
timeFrame: baseline, 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Laura Raffals, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04680455: Strength Training for Men Living With Obesity
Official title: Potential Benefits of Strength Training for Men Living With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Physical Activity
Men
Strength Training
Lead sponsor: University of New Brunswick
Sponsor class: OTHER
First posted: 2020-12-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: PREVENTION

Brief summary: Emerging evidence suggests that alternative obesity management strategies need to address barriers to engaging with regular physical activity to adopt healthier lifestyles. It is hypothesized that more men living with obesity who are exposed to an online home-based circuit strength training for 12 weeks will be more physically active, 34 weeks after the intervention compared with people who are not exposed to the program.

Detailed description: Sixty men (age ≥ 18 years; body fat % ≥ 25) were randomly assigned to the intervention group (N=30) or the control condition (N=30) for 12 weeks. The intervention group did the online delivered circuit training, three sessions in a week. Adherence to the weekly physical activity guidelines was evaluated 46 weeks after being enrolled in the program using a heart rate tracker and an exercise log. Most variables (anthropometrics, body composition, resting heart rate, blood pressure, lipids profile, glucose) were measured at baseline and after 12, 24, and 46 weeks. Aerobic fitness and comfort with technology were measured at baseline. Perceived benefits/barriers of participation in exercise were captured at baseline and 12 weeks.

More participants in the intervention group adhered to the physical activity guidelines compared to the control group at 46 weeks (intervention 36.8% vs control 5.3%; p=0.021). However, the intervention group did not improve their health outcomes after 12, 24, and 46 weeks. Fewer barriers were reported after 12-week for the intervention group (p=0.02).

Eligibility criteria: Inclusion Criteria:

* men
* Body fat% of 25% or more
* Not reaching physical activity guidelines (150 min of moderate to vigorous intensity of aerobic exercises + two sessions of resistance training)
* being able to do weight training

Exclusion Criteria:

- Taking medications that can cause to change in heart rate

Primary outcomes:
measure: Physical activity Level
timeFrame: 48 weeks
Secondary outcomes:
measure: Cardiorespiratory fitness
timeFrame: Baseline
measure: BMI
timeFrame: 46 weeks
measure: Waist circumference
timeFrame: 46 weeks
measure: Body fat percentage
timeFrame: 46 weeks
measure: Muscle mass
timeFrame: 46 weeks
measure: Metabolic profile
timeFrame: 46 weeks
Other outcomes:
Locations:
city: Fredericton
country: Canada
facility: University of New Brunswick
state: New Brunswick
Study officials:
References:
Clinical trial NCT02977650: EUS-FNA for Patients Taking Anticoagulants Without Heparin Bridge
Official title: EUS-FNA for Patients Taking Anticoagulants Without Heparin Bridge
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endoscopic Ultrasonography-guided Fine Needle Aspiration
Lead sponsor: Hokkaido Pancreatobiliary Endoscopic Intervention Study Group
Sponsor class: NETWORK
First posted: 2016-11-30
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients taking anticoagulants who underwent EUS-FNA

Brief summary: To evaluate the feasibility of EUS-FNA for patients taking anticoagulants without heparin bridge.


Eligibility criteria: Inclusion Criteria:

* Taking anticoagulants
* Written informed consent

Exclusion Criteria:

* Platelets count less than 50000/μl
* PT-INR more than 2.6
* ASA more than 3
* Severe bleeding tendency

Primary outcomes:
measure: The rate of bleeding adverse events
timeFrame: Within 2 weeks
Secondary outcomes:
measure: The rate of thromboembolic events
timeFrame: Within 2 weeks
measure: The rate of other adverse events
timeFrame: Within 2 weeks
Other outcomes:
Locations:
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
Study officials:
References:
Clinical trial NCT00887250: A Study to Investigate the Antihypertensive Efficacy of MK0954
Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Clinical Study to Evaluate the Antihypertensive Efficacy and Safety of Losartan (MK954, DuP753) in Patients With Mild to
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-04-23
Enrollment: 366
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: After a 4 week placebo period, patients were randomized to Placebo or Losartan 50 mg arms, after 6 weeks non-responders were up titrated to 100 mg losartan for the remaining 6 weeks. This study evaluated if losartan is more effective than placebo in lowering sitting diastolic blood pressure and is well tolerated in patients with mild to moderate hypertension.


Eligibility criteria: Inclusion Criteria:

* Patient has been diagnosed with mild to moderate hypertension (SDBP 95-115 mm Hg)
* Patient has no medical problems or treatments that might effect their blood pressure

Exclusion Criteria:

* Pregnant or lactating females
* Patient has secondary hypertension or malignant hypertension
* Sitting systolic blood pressure \> 210 mm Hg
* History of stroke
* History of myocardial infarction with in past year
* Current or prior history of heart failure
* Known hypersensitivity to losartan
* Prior exposure to losartan
* Patients known to be HIV positive
* Patient is abusing or has abused alcohol or other drugs within the past 4 years

Primary outcomes:
measure: Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12
timeFrame: At baseline and at 12 weeks (24 hours post dose)
Secondary outcomes:
measure: Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 6
timeFrame: 24 hours post dose at Week 6
measure: Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 12
timeFrame: 24 hours post dose at Week 12
measure: Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 6
timeFrame: At baseline and at 6 weeks (24 hours post dose)
measure: Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 6
timeFrame: At baseline and at 6 weeks (24 hours post dose)
measure: Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12
timeFrame: At baseline and at 12 weeks (6 hours post dose)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05673850: Association Between HER2 Status and pCR Rate in ER-positive Breast Cancer Receiving Neoadjuvant Endocrine or Chemotherapy
Official title: Association Between HER2 Status and pCR Rate in ER-positive Breast Cancer Receiving Neoadjuvant Endocrine or Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2023-01-06
Enrollment: 518
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this retrospective cohort study, we sourced data from the electronic database of Peking university cancer hospital to identify patients diagnosed with invasive breast cancer and who received surgery from 2015 to 2021. Patients were excluded by the fol-lowing criteria: (1) patients who were ER-negative; (2) patients who were HER2 posi-tive defined as IHC3+ or IHC2+/fluorescence in situ hybridization (FISH)-positive; (3) patients who were HER2 (IHC2+) but did not evaluate by further FISH;(4) patients who did not receive neoadjuvant therapy; (5) patients who received concurrent neo-adjuvant endocrine and chemotherapy. Patients who remained were further divided into two groups: those receiving neoadjuvant endocrine therapy (the NET group) and those receiving neoadjuvant chemotherapy (the NCT group).

Brief summary: In estrogen receptor (ER)-positive breast cancer (BC), human epidermal growth factor receptor-2 (HER2)-low ones are reported to have distinct clinical and molecular features from those with HER2-zero or HER2-positive status. However, the association between HER2-low status with response to endocrine therapy is largely unknown. In this study, we included 518 ER-positive BC patients who received either neoadjuvant endocrine therapy (NET) or neoadjuvant chemotherapy (NCT). The pathologic complete response rate (pCR) of HER2-low and HER2-zero tumors re-sponding to neoadjuvant therapies were compared. The difference in disease-free survival (DFS) and overall survival (OS) between the two groups was also analyzed. The pCR (defined as ypT0/isNx) in HER2-low BCs and in HER2-zero BCs for NET cohort and NCT cohort were compared.


Eligibility criteria: Inclusion Criteria:

patients diagnosed with invasive breast cancer and who received surgery from 2015 to 2021

Exclusion Criteria:

none

Primary outcomes:
measure: pathologic complete response rate (pCR)
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Haidian
country: China
facility: Peking University Cancer Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT02118350: Effect of Mat Pilates Training on Blood Pressure of Hypertensive Individuals
Official title: Effect of Mat Pilates Training on Blood Pressure of Hypertensive Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2014-04-21
Enrollment: 44
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aimed to evaluate the chronic effects of Mat Pilates Training on blood pressure, heart rate, double product and psychobiological factors in hypertensive medicated women and acute effects of Mat Pilates Exercise on blood pressure of such individuals.


Eligibility criteria: Inclusion Criteria:

* Hypertensives women
* Age 30 to 59 years
* Nonactive
* Make use of antihypertensive medication

Exclusion Criteria:

* Orthopedic problems or other problem that prevented the exercises
* Change in drug treatment during protocol
* Absence in more than 25% of the exercise sessions

Primary outcomes:
measure: Blood pressure
timeFrame: 16 weeks
Secondary outcomes:
measure: Heart Rate
timeFrame: 16 weeks
measure: Anxiety
timeFrame: 16 weeks.
measure: Stress
timeFrame: 16 weeks
measure: Depression
timeFrame: 16 weeks
measure: Sleep quality
timeFrame: 16 weeks
measure: Perception of Sleep
timeFrame: 16 weeks
measure: Sleepiness
timeFrame: 16 weeks
measure: Quality of Life
timeFrame: 16 weeks
measure: Flexibility
timeFrame: 16 weeks
measure: Strength
timeFrame: 16 weeks
measure: Body weight
timeFrame: 16 weeks
measure: Height
timeFrame: 16 weeks
measure: Waist circumference
timeFrame: 16 weeks
measure: Hip circumference
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Santos
country: Brazil
facility: Federal University of Sao Paulo
state: SP
Study officials:
References: