louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05295940: A Study of LY3841136 in Healthy and Overweight Participants
Official title: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3841136 in Healthy and Overweight Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-03-25
Enrollment: 148
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: BASIC_SCIENCE

Brief summary: The main purpose of this study is to evaluate the safety and tolerability of LY3841136 in healthy and overweight participants. Blood tests will be performed to check how much LY3841136 gets into the bloodstream and how long it takes the body to eliminate it. This is a 2-part study and may last up to 14 and 28 weeks for each participant and may include 7 and 19 visits in parts A and B, respectively.


Eligibility criteria: Inclusion Criteria:

* Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential
* Have had a stable weight for the last 3 months
* Have a body mass index (BMI) in the range of 18.5 to 32 kilogram per square meter (kg/m²), both inclusive (in Part A) or a BMI in the range of 27 to 40 kg/m², both inclusive (in Part B)

Exclusion Criteria:

* Are women who are lactating
* Have known allergies to related compounds of LY3841136 or any components of the formulation
* Have a history of significant atopy (severe or multiple allergic manifestations), or clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions
* Have been diagnosed with Type 1 or Type 2 diabetes mellitus
* Have a history of chronic medical conditions involving the heart, liver, or kidneys

Primary outcomes:
measure: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Predose up to 14 weeks (Part A) & 28 weeks (Part B)
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3841136
timeFrame: Predose through week 14 (Part A) & week 28 (Part B)
measure: PK: Maximum Observed Concentration (Cmax) of LY3841136
timeFrame: Predose through week 14 (Part A) & week 28 (Part B)
measure: Pharmacodynamics (PD): Change From Baseline in Body Weight
timeFrame: Predose through week 28
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Fortrea Clinical Research Unit
state: Florida
city: Dallas
country: United States
facility: Fortrea Clinical Research Unit
state: Texas
city: Madison
country: United States
facility: Fortrea Clinical Research Unit
state: Wisconsin
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00531440: This is a 2-year Follow-up Study to Evaluate the Long-term Effects in Patients Who Completed the Study CRAD001A2307.
Official title: A 2 Year Extension to a 1 Year Multicenter, Randomized, Open Label, Parallel Group Study of the Safety, Tolerability and Efficacy of Two Doses (1.5 and 3 mg/Day) of Everolimus (RAD001) With Basiliximab, Corticosteroids and Optimized Administration of Cyclosporine in de Novo Renal Transplant Recipients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Transplantation
Keywords: Renal transplantation, everolimus, Immunosuppressants
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-09-18
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This extension study is designed to provide long-term safety and efficacy data beyond 12 months up to Month 36.


Eligibility criteria: Inclusion Criteria:

* Patients who are receiving study medication at Month 12 (CRAD001A2307) and sign a new Informed Consent to extend the treatment or observation period beyond Month 12.
* Female patients must agree to continue using an approved method of birth control throughout the study and for 3 months following the last dose of study medication.
* Another Informed Consent was required for the extension amendment. This Informed Consent allowed for separate consent to the amendment study itself, and the retrospective collection of biopsies and/or the yearly protocol biopsies.
* Inclusion and exclusion criteria were not changed, except that patients who completed the core study in follow-up became eligible to participate in the amended extension.

Exclusion Criteria:

* Patients who are receiving study medication and do not sign a new Informed Consent to extend the treatment and observation period beyond Month 12 cannot enter the extension.

Primary outcomes:
measure: graft loss, death, biopsy-proven acute rejection,antibody-treated ,biopsy-proven chronic allograft nephropathy,retransplantation/dialysis up to 36m renal function measured by creatinine clearance Cockcroft-Gault)calculated glomerularfiltration rate
Secondary outcomes:
measure: biopsy-proven acute rejection episodes,graft loss, deathor lost to follow-up 6,12,24&3677 Mths both groups.assess the incidence of graft loss, death, biopsy-proven acute rejection, antibody-treated acute rejection, clinically-confirmed acute rejection.
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
Clinical trial NCT05520840: Evaluation of Peripheral Blood Protein Biomarkers for Colorectal Cancer Screening
Official title: Evaluation of Peripheral Blood Protein Biomarkers for Colorectal Cancer Screening
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Keywords: biomarkers
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
Collaborators: name: OncoDiag
name: University Hospital, Caen
First posted: 2022-08-30
Enrollment: 350
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to validate the value of value of peripheral blood protein biomarkers in colorectal cancer screening, and to identify new ones


Eligibility criteria: Inclusion Criteria:

* Patient aged 50 years or older referred for screening colonoscopy after a positive FIT test or for endoscopic resection of a previously identified suspicious colorectal lesion

Exclusion Criteria:

* Very high risk of colorectal cancer: Lynch syndrome, Familial adenomatous polyposis, Peutz-Jeghers syndrome, Familial polyposis associated with a MutYH gene defect
* Other solid cancers or haematological malignancies that are progressive and/or undergoing treatment (apart from basal cell skin carcinoma)
* Contraindication to total colonoscopy

Primary outcomes:
measure: Number of patient with advanced neoplasia at colonoscopy
timeFrame: Day 1
measure: Number of patient with presence of best isolated serum biomarkers selected from different candidates
timeFrame: Day 1
Secondary outcomes:
measure: Number of patient with presence of other isolated serum biomarkers selected from different candidates
timeFrame: Day 1
Other outcomes:
Locations:
city: Bois-Guillaume
country: France
facility: Clinique du Cèdre
city: Caen
country: France
facility: Caen University Hospital
city: Dijon
country: France
facility: Dijon University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Adrien Grancher, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06259240: Prone Plank Exercises for Diastasis Rectus Abdominis in Postpartum Women
Official title: Prone Plank Exercises Versus Electrical Stimulation in Treatment of Diastasis Rectus Abdominis in Postpartum Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Partum Women
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 42
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 this study was to compare between the effects of prone plank exercises versus ES for DRA in postpartum women.

Detailed description: The study conducted on forty-two woman. They had diastasis rectus abdominis12 weeks to 36 months postpartum. They were randomly divided into two equal groups; group A received prone plank exercises while group B recieved electrical stimulation.All patients recieved three sessions per week foe eight weeks.

Eligibility criteria: Inclusion Criteria:

* they had DRA 12 weeks to 36 months postpartum, and were referred to physiotherapy by a gynaecologist, multiparous with the IRD measuring greater than two cm. Age ranged between 20-35 years. Body mass index didn't exceed 30 kg/m2.

Exclusion Criteria:

* they were in ongoing pregnancy, twin pregnancy, premature birth before gestation week 37, and exceeded more than thirty-six months postpartum.

Primary outcomes:
measure: Ultrasound Imaging Device
timeFrame: Eight weeks after the beginning of the intervention
measure: Ultrasound Imaging Device
timeFrame: Eight weeks after the beginning of the intervention
measure: Ultrasound Imaging Device
timeFrame: Eight weeks after the beginning of the intervention
measure: Ultrasound Imaging Device
timeFrame: Eight weeks after the beginning of the intervention
Secondary outcomes:
measure: The measuring tape
timeFrame: Eight weeks after the beginning of the intervention
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Faculty of physical therapy labs at kafr El sheikh University
Study officials:
affiliation: Kafrelsheikh University
name: Fayiz Elshamy, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03252340: Safety of ADSTEM Injection in Patients With Moderate to Severe Subacute and Chronic Atopic Dermatitis
Official title: Observational Study to Evaluate the Safety of ADSTEM Injection in Patients With Moderate to Severe Subacute and Chronic Atopic Dermatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atopic Dermatitis
Lead sponsor: EHL Bio Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-08-17
Enrollment: 11
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who participated in Phase I clinical trials

Brief summary: This study aims to evaluate safety in subjects with over moderately subacute and chronic atopic dermatitis after an intravenous injection of ADSTEM Inj. Since this is an observational study of patients participated in Phase 1 clinical trials, no drug is administered in this study.

Detailed description: Participants will be followed-up for adverse events on each visit. Visits will be on 6, 12, 18, 24, 30, 36, 48, 60months after treatment of ADSTEM Inj.

Time perspective is both retrospective and prospective.

Eligibility criteria: Inclusion Criteria:

* Patients who participated in Phase I clinical trials
* Patients who voluntarily agreed to participate in the study

Exclusion Criteria:

* Patients who can not follow-up from the end of the phase 1 clinical trial to the end of the study

Primary outcomes:
measure: Tumor formation
timeFrame: 60months after treatment of ADSTEM Inj.
Secondary outcomes:
measure: Adverse events
timeFrame: 60months after treatment of ADSTEM Inj.
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
state: Chungcheongnam-do
Study officials:
affiliation: Chungnam National University Hospital
name: Young-joon Seo, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05589740: Culturally Optimized Messages for Latinos
Official title: Wellness With Culturally Optimized Messages for Ethnic-diverse Latinos
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet, Healthy
Diet Habit
Obesity
Blood Pressure
Psychological
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 76
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This project aims to redesign and optimize a deep-structure culturally-tailored healthy eating program and test its effectiveness in improving dietary outcomes, anthropometric, and blood pressure among 75 diverse Latinos, compared to surface-level messages.

Detailed description: This project aims to redesign and optimize a deep-structure culturally-tailored healthy eating program and test its effectiveness in improving dietary outcomes, anthropometric, and blood pressure among 75 diverse Latinos, compared to surface-level messages. The WELCOME study will be based on the RE-AIM framework with improved reach, adoption, implementation, and maintenance strategies. The intervention arm is a deep-structure cultural tailored text messages for distinct Latino heritages (e.g., Caribbean and non-Caribbean) informed by mixed-methods formative research, compared to surface-level healthy eating messages based on the USDA My Plate Spanish version. The program runs for 6 months: 2-months delivery phase + 2-months reinforcement phase + 2-months maintenance phase.

Eligibility criteria: Inclusion Criteria:

* age 25-65 y/o
* self-reported Hispanic/Latino heritage
* able to understand and answer questions in Spanish or English
* living in Massachusetts for the past year and not planning to move in the next year
* having a cellphone with the capacity of receiving and sending text messages and giving consent for the Study to text this number as part of the intervention

Exclusion Criteria:

1. self-reported diagnosis of cancer, diabetes or major stomach or heart condition (e.g.: gastrointestinal cancers, coronary heart disease, previous stroke or heart attack, severe dietary allergies or restrictions)
2. planning to move Massachusetts in the next year
3. currently pregnant
4. institutionalized (i.e.: hospital, prison, etc.).

Primary outcomes:
measure: Changes in diet quality score
timeFrame: Month 4
measure: Change in levels of adipose risk factor
timeFrame: Month 4
measure: Change in levels of blood pressure risk factor
timeFrame: Month 4
measure: Change in dietary habits
timeFrame: Month 4
Secondary outcomes:
measure: Changes in diet satisfaction: diet satisfaction scale
timeFrame: Month 4
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard TH Chan School of Public Health
state: Massachusetts
Study officials:
affiliation: Harvard Chan School of Public Health
name: Josiemer Mattei, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02004340: Transcutaneous Auricular Vagus Nerve Stimulation for Pediatric Epilepsy
Official title: Transcutaneous Auricular Vagus Nerve Stimulation as a Complementary Treatment for Pediatric Epilepsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Epilepsy
Keywords: pediatric epilepsy
transcutaneous vagus nerve stimulation
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Beijing Tiantan Hospital
name: Beijing Children's Hospital
First posted: 2013-12-09
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether transcutaneous auricular vagus nerve stimulation as a complementary therapy is effective in the treatment of pediatric epilepsy.


Eligibility criteria: Inclusion Criteria:

* Diagnosed as epilepsy;
* With age between 2-18 years old;
* The number and dose of the medication was kept constant no less than eight weeks before intervention;
* The patients or their guardians can count the frequency of the seizures and finish the study.

Exclusion Criteria:

* The patient is receiving the VNS therapy;
* Accompanied with progressive central nervous system diseases;
* Have severe heart, liver ,kidney or blood diseases;
* Be pregnant or having the schedule of pregnancy in the study period.

Primary outcomes:
measure: frequency of epileptic seizures
timeFrame: Change from baseline at 8, 16, 24 weeks respectively in frequency of epileptic seizures
Secondary outcomes:
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: participants will be followed for the duration of TVNS intervention, an expected average of 8 weeks"
Other outcomes:
Locations:
city: Beijing
country: China
facility: Wei He
Study officials:
affiliation: Institute of Acupuncture and Moxibustion, CACMS
name: Bing Zhu, Dr.
role: STUDY_DIRECTOR
References:
citation: He W, Wang XY, Zhou L, Li ZM, Jing XH, Lv ZL, Zhao YF, Shi H, Hu L, Su YS, Zhu B. Transcutaneous auricular vagus nerve stimulation for pediatric epilepsy: study protocol for a randomized controlled trial. Trials. 2015 Aug 21;16:371. doi: 10.1186/s13063-015-0906-8.
Clinical trial NCT06524440: Hypertensive Heart Disease in DR Congo
Official title: Comorbidities and the Management of Hypertensive Heart Disease in a Low-Resource Setting: A Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypertensive Heart Disease
Keywords: Comorbidities
Democratic Republic of Congo
Hypertensive heart disease
Management
Lead sponsor: Association of Future African Neurosurgeons, Yaounde, Cameroon
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients 18 year or older diagnosed with hypertensive heart disease at Monkole Mother and Infant Hospital Center from January to December 2019

Brief summary: In this Cross-sectional study, we will analyzed data from a tertiary referral Congolese hospital to find whether or not Congolese patients with hypertensive heart disease have multiple comorbid conditions. Will report on the management and outcomes of the patients.

Detailed description: This will be done by collecting individual data on BMI, dyslipidemia, stroke, diabetes, serum creatinine, HDL, LDL, and urea levels for patients diagnosed with hypertensive heart disease.

Eligibility criteria: Inclusion Criteria:

* Patients is 18 year or older
* Patient is diagnosed with hypertensive heart disease

Exclusion Criteria:

* Patient is not 18 year or older
* Patient is not diagnosed with hypertensive heart disease

Primary outcomes:
measure: High Systolic Blood Pressure
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: Monkole Mother and Infant Hospital Center
Study officials:
affiliation: Faculty of Medicine, Bel Campus University of Technology, Kinshasa, Democratic Republic of Congo
name: Raïssa K Kongue, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02530840: Improving Adherence and Commitment to Treatment in Diabetic Patients
Official title: Impact:Improving Adherence and Commitment to Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Keywords: imbalanced diabetic patients
HbA1c
peers
Lead sponsor: Clalit Health Services
Sponsor class: OTHER
First posted: 2015-08-21
Enrollment: 500
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In the IMPACT project, the investigators want to improve adherence and commitment to treatment.

Detailed description: In this study the investigators use 3 interventions in diabetic patients and one control, to find what is the best intervention to improve adherence to healthy life style and medication therapy. the 3 intervention as followed: 1) meetings and follow-up by the medical team; 2) meetings and follow-up by trained peers; 3) system for sending SMS, operate according to algorithm.

Eligibility criteria: Inclusion Criteria:

1. type 2 diabetes
2. age 30-70
3. Oral medication or insulin
4. According to the HbA1c test result, 0.5% above the target for the patient's personal balance and below the 10%, the most recent, but in any event not more than six months prior to the study patient recruitment
5. BMI\<35
6. Patients speak and read Hebrew
7. owners of a mobile phone that can receive text messages (SMS messages/ notifications) and have the ability to use the application (relevant for the SMS notification arm)

Exclusion Criteria:

1. Active malignant disease
2. creatinine levels above 2
3. Getting medicines that elevate sugar levels as steroids, chemotherapy
4. Three months after Myocardial Infraction (myocardial ischemia), surgical intervention, cardiac event
5. Patients who are planning major surgery
6. Patients who are planning a residential zone change
7. Patients with acute complications of diabetes under active treatment (such as limb amputation)
8. Patients diagnosed with unbalanced mental disorders
9. patients who can not sign the form on their own "informed consent"
10. patients suffering from dementia
11. Patients who are not mobile (dependent on the therapist)

Primary outcomes:
measure: Diabetes Control as Expressed by the Change in HbA1c %
timeFrame: 0, 6, 12 & 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Clalit Health Institute
Study officials:
affiliation: Director of the Department of promoting quality of family medicine
name: Margalit Goldfracht, prof.
role: PRINCIPAL_INVESTIGATOR
References: