louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04539639: Clinical Study of Jaktinib in the Treatment of Patients With Moderate and Severe Atopic Dermatitis
Official title: A Multi-center,Randomized,Double-blind,Placebo,Parallel-controlled Phase II Clinical Study of Jaktinib Hydrochloride Tablets in the Treatment of Moderate and Severe Atopic Dermatitis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2020-09-07
Enrollment: 166
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 purpose of this study is to evaluate the efficacy and safety of Jaktinib in participants with moderate to severe atopic dermatitis.

Detailed description: The study is divided into two stages, the first stage test (1-12 weeks): the main test; the second stage test (13-24 weeks): the extended test.

The main test：The trial set up 4 treatment groups, including 3 dose exploration groups, Jaktinib 50mg Bid, 75mg Bid, 100mg Bid group and 1 placebo control group.

The extended test：Subjects in the placebo group were randomly assigned to receive Jaktinib 50mg Bid, 75mg Bid, and 100mg Bid treatments at a ratio of 1:1:1 (randomized in a blinded state and completed by IWRS in the background), the main test group (50mg Bid, 75mg Bid, 100mg Bid group) subjects still maintain the original dose after 12 weeks.

Eligibility criteria: Inclusion Criteria:

* Meet the Chinese diagnostic criteria for atopic dermatitis (Zhang's criteria) and be diagnosed as atopic dermatitis.
* Participants must have moderate to severe AD at screening and randomization.
* Participants must have inadequate response to topical medications within 6 months of screening.
* Agree to use emollients daily

Exclusion Criteria:

* Received prior treatment with any oral Janus kinase (JAK) inhibitor less than 4 weeks prior to randomization.
* Have received certain types of vaccinations.
* Participants who do not agree to use adequate contraception during the trial and within 4 weeks after the last dose.
* Any Participants whom the investigator deems inappropriate for participation in this clinical study

Primary outcomes:
measure: Percentage of Participants Achieving at least a 50% Reduction in Eczema Area and Severity Index (EASI 50) from Baseline
timeFrame: At Week 12
Secondary outcomes:
measure: Percentage of Participants Achieving IGA of 0 or 1.
timeFrame: Treatment at 2,4,8,12,16,20,24 weeks
measure: Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 with a ≥2 Point Improvement
timeFrame: Treatment at 2,4,8,12,16,20,24 weeks
Other outcomes:
Locations:
city: Changsha
country: China
facility: The second xiangya hospital of central south university
state: Hunan
Study officials:
affiliation: Central South University
name: Qianjin Lu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02610439: Whole Exome Sequencing in Finding Causative Variants in Germline DNA Samples From Patients With Peripheral Neuropathy Receiving Paclitaxel for Breast Cancer
Official title: Exploratory Next Generation Sequencing to Identify Causative Variants for Taxane-Induced Peripheral Neuropathy From Breast Cancer Study E5103 Germline DNA Samples
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Carcinoma
Neuropathy
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2015-11-20
Enrollment: 575
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with breast cancer enrolled on E5103 with or without peripheral neuropathy.

Brief summary: This research trial studies whole exome sequencing in finding causative variants in germline deoxyribonucleic acid (DNA) samples from patients with peripheral neuropathy receiving chemotherapy for breast cancer. Studying samples of germline DNA in the laboratory from patients with peripheral neuropathy receiving paclitaxel for breast cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to peripheral neuropathy.

Detailed description: PRIMARY OBJECTIVES:

I. To identify, using next generation sequencing, rare variants of large effect size that impact the risk of peripheral neuropathy in patients of African and European descent in the clinical trial ECOG-5103 (E5103).

OUTLINE:

Previously collected germline DNA samples are analyzed via whole exome sequencing.

Eligibility criteria: Inclusion Criteria:

* European American patients with DNA available and designated case or control
* African American patients with DNA available and designated case or control status
* Patients who developed grade 2-4 for African American (AA) and grade 3-4 for European American (EA) peripheral neuropathy during their treatment with paclitaxel and who did not develop peripheral neuropathy following a full course of treatment with paclitaxel

Primary outcomes:
measure: Identification of rare coding variants of large effect that predict the risk of peripheral neuropathy
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Eastern Cooperative Oncology Group
state: Massachusetts
Study officials:
affiliation: Eastern Cooperative Oncology Group
name: Bryan P Schneider
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02059486: Impact Evaluation of the Teen Choice Program
Official title: Impact Evaluation of the Teen Choice Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sexual Behavior
Lead sponsor: Mathematica Policy Research, Inc.
Sponsor class: OTHER
First posted: 2014-02-11
Enrollment: 465
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the impact of the Teen Choice program on reducing the rates of unprotected sex of high risk youth in New York.

Detailed description: This study uses a randomized controlled design to compare the impacts of the Teen Choice Program to the "business-as-usual" school curriculum. The Teen Choice curriculum is designed for adolescents aged 12 to 19 and will be delivered in different formats that range in length from 6 to 12 weeks. Teen Choice will be offered during the regular school day to middle and high school aged youth. This study is being conducted as part of the national Personal Responsibility Education Program evaluation funded by Administration for Children and Families within the U.S. Department of Health and Human Services.

Eligibility criteria: Inclusion Criteria:

* Age 12-19
* Attending one of the participating schools

Exclusion Criteria:

* Juvenile Justice Youth
* School clinician determined trauma histories
* School clinician determined developmental issues

Primary outcomes:
measure: Unprotected sex in the three months prior to the survey
timeFrame: 6-months post random assignment
Secondary outcomes:
measure: Sexual Initiation
timeFrame: 6-months post intervention
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Bronx Community High School
state: New York
city: Brooklyn
country: United States
facility: R.O.A.D.S.
state: New York
city: Dobbs Ferry
country: United States
facility: Clark Academy
state: New York
city: New York
country: United States
facility: Robert H Goddard High School
state: New York
city: Yonkers
country: United States
facility: Biondi School
state: New York
Study officials:
affiliation: Mathematica Policy Research
name: Robert Wood, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00286039: Plasma Citrulline Level in Relation to Absorptive Surface
Official title: Plasma Citrulline Level in Relation to Absorptive Surface
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intestinal Failure
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2006-02-02
Enrollment: 200
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Correlation between determination of citrulline in plasma or dried blood

Reference ranges for healthy children and babies

Longitudinal follow-up of citrulline in preterm babies


Eligibility criteria: Inclusion Criteria:

* 0-18 years
* preterm babies up to 1.500g
* preterm babies over 1.500g

Exclusion Criteria:

* gastro-intestinal problems (except for the preterm babies)
* congenital metabolic disorders
* dysfunction of the liver or kidneys
* congenital defects

Primary outcomes:
measure: Correlation between determination of citrulline in plasma or dried blood
timeFrame: Untill end of study
measure: Reference ranges for healthy children and babies
timeFrame: Until end of study
measure: Longitudinal follow-up of citrulline in preterm babies
timeFrame: Untill end of study
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Eddy Robberecht, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04742439: Individualizing tDCS Dose
Official title: Testing the Effects of Individualized and 4mA tDCS
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: tDCS
Motor Function
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-02-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Transcranial direct current stimulation (tDCS) is a noninvasive method of modulating brain activity and has therapeutic potential in many neurological and psychiatric conditions. However, unlike every current FDA-approved form of brain stimulation, there is no method of individualizing stimulation dose. In this study, a method of individualizing tDCS dose on behavioral outcomes and whether this could help to improve the consistency and magnitude of the stimulation effects will be tested.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers or chronic stroke participants (at least 6 months prior to the study)
* No history of epilepsy
* No metal in the body
* No contraindications for TMS or MRI scanning
* Right handed
* Ability to find motor hotspot and acquire motor evoked potentials

Exclusion Criteria:

* Metal in the body
* History of epilepsy or claustrophobia
* Alcohol or substance abuse or dependence
* Current treatment for any psychiatric conditions (pharmacological or otherwise)
* Pregnant or actively breastfeeding

Primary outcomes:
measure: Change in Motor Evoked Potential Variance
timeFrame: Baseline and post-stimulation (20 minutes apart)
measure: Difference in Motor Evoked Potential Amplitudes from 4mA and 2mA Stimulation
timeFrame: Baseline and post-stimulation (20 minutes apart)
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Mark S George, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03081039: A Study of Cisplatin or Carboplatin With Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Patients With Resected or Ablation Intra-Hepatic Cholangiocarcinoma
Official title: A Phase III, Multicenter, Open-Label, Randomized Study of Cisplatin or Carboplatin With Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Patients With Resected or Ablated Intra-Hepatic Cholangiocarcinoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Intrahepatic Cholangiocarcinoma
Keywords: cholangiocarcinoma
gemcitabine
carboplatin
cisplatin
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2017-03-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized 1:1 to one of two treatment arms.
Primary purpose: TREATMENT

Brief summary: Compare the efficacy of adjuvant chemotherapy with Cisplatin or Carboplatin and Gemcitabine versus Gemcitabine in patients with resected or ablated intra-hepatic cholangiocarcinoma.

Detailed description: Phase III, multicenter, open label, randomized study of Cisplatin or Carboplatin with Gemcitabine versus Gemcitabine alone as adjuvant therapy in patients with resected or ablated intra-hepatic cholangiocarcinoma. Subjects will be randomized in a 1:1 fashion to Cisplatin or Carboplatin with Gemcitabine versus Gemcitabine alone.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age, of any race or sex who are eligible to sign written consent and have undergone prior resection of histological evidence of intrahepatic cholangiocarcinoma
* Hematologic function: ANC ≥ 1.5 x 10 /L, platelets ≥ 75 x 10 /L, and hemoglobin \> 9 g/dL
* Adequate liver function as measured by: total bilirubin ≤ 2.0 mg/dl, AST and ALT ≤ 5 ULN, albumin ≥ 2.5 g/dl
* Adequate renal function as measured by: creatinine ≤ 2.9 mg/dl, \> 50 ml/min calculated by the C-G equation
* Non-pregnant women of child bearing potential and fertile men are required to use effective contraception (negative pregnancy test for women of child-bearing age)
* ECOG status ≤ 1 at screening

Exclusion Criteria:

* Subjects will be eligible for the study if they meet all inclusion criteria

Primary outcomes:
measure: Overall Survival
timeFrame: Every three months for 4 years
Secondary outcomes:
measure: Progression Free Survival
timeFrame: Every three months for 4 years.
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Robert Martin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01977339: Efficacy of Single Injection Femoral Nerve Block With Liposomal Bupivacaine for Total Knee Arthroplasty
Official title: A Randomized, Double-Blinded, Control Trial to Evaluate the Efficacy of Single Injection Femoral Nerve Block With Liposome Bupivacaine for Postsurgical Analgesia in Subjects Undergoing Unilateral Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Total Knee Arthroplasty
Keywords: Femoral Nerve Block
Liposomal Bupivacaine
Lead sponsor: St. Luke's-Roosevelt Hospital Center
Sponsor class: OTHER
First posted: 2013-11-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
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 compare the quality and duration of pain relief after a total knee replacement provided by a single shot of standard bupivacaine versus a single shot of liposomal bupivacaine, at the site of the femoral nerve. It is hypothesized that the liposomal bupivacaine formulation will provide more effective pain relief than standard bupivacaine.


Eligibility criteria: Inclusion Criteria:

1. Male or female, ≥18 years of age
2. Scheduled to undergo primary unilateral TKA under general anesthesia.
3. American Society of Anesthesiology (ASA) Physical Status I-III
4. Able to demonstrate motor function by performing a 20-meter walk, and sensory function by exhibiting sensitivity to cold.
5. Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.

Exclusion Criteria:

1. Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration.
2. Planned concurrent surgical procedure (e.g., bilateral TKA).
3. Body weight \< 50 kg (110 pounds) or a body mass index ≥ 40 kg/m2.
4. Contraindication to any of the pain-control agents planned for postsurgical use (i.e., morphine, hydromorphone, oxycodone, bupivacaine).
5. Previous participation in a liposome bupivacaine study.
6. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
7. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, could interfere with study assessments or compliance.

Primary outcomes:
measure: Opiate consumption
timeFrame: 72 hours
Secondary outcomes:
measure: Post-operative VAS scores
timeFrame: 1 hr, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 48 hrs, 72 hrs
Other outcomes:
measure: Sensory mapping (temperature)
timeFrame: 72 hours
measure: Motor function assessment
timeFrame: 72 hours
Locations:
city: New York
country: United States
facility: St. Luke's-Roosevelt Hospital Center
state: New York
Study officials:
affiliation: St. Luke's-Roosevelt Hospital Center
name: Ali Shariat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05638139: Treatment of Ano-perineal Fistulas Resistant to Surgical Treatment with a Gel and Plug of Wharton's Jelly
Official title: Treatment of Ano-perineal Fistulas Resistant to Surgical Treatment with a Gel and Plug of Wharton's Jelly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anal Fistula
Lead sponsor: TBF Genie Tissulaire
Sponsor class: INDUSTRY
First posted: 2022-12-06
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this open, multicenter pilot trial is to evaluate the tolerance of the combination of a gel and a plug made of Wharton's jelly in the treatment of ano-perineal fistulas resistant to surgical treatment.


Eligibility criteria: Inclusion Criteria:

* Male or female, aged 18 to 65 years.
* Patient with a single anal fistula resistant after at least one surgical treatment. Fistula may be related to Crohn's disease.
* Patient with an upper transsphincteric or lower transsphincteric fistula.
* Patient presenting fistula with or without intersphincteric diverticula.
* Fistula effectively drained with a seton.
* Informed and consenting patient.
* Patient who is a member or a beneficiary of a national health insurance plan.

Exclusion Criteria:

* Pregnant or breastfeeding woman or woman of childbearing age without effective contraception.
* Patients who have had more than one failed obstruction technique.
* Patient with more than one internal orifice.
* Patient with an MRI proven abscess.
* Patient with an uncontrolled infection.
* Patient with a contraindication to anesthesia.
* Person deprived of liberty by a judicial or administrative decision.
* Adult subjected to a legal protection measure or unable to express his / her consent.

Primary outcomes:
measure: Evaluation of intensity of perineal inflammation following treatment
timeFrame: Through study completion (45 days)
measure: Rate of plug expulsion and surgical revision due to complications
timeFrame: Through study completion (45 days)
measure: Type and incidence of adverse events (AE) and serious adverse events (SAE)
timeFrame: Through study completion (45 days)
Secondary outcomes:
measure: Evaluation of surgical technique
timeFrame: Time of investigational products surgical implantation (Day 0)
measure: Plug integration
timeFrame: 30 days, 45 days
measure: Cessation of fistula flow
timeFrame: 45 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Clinique Blomet
city: Talence
country: France
facility: Maison de Santé Protestante de Bordeaux-Bagatelle
Study officials:
References:
Clinical trial NCT05366439: Study of AT-752 in Healthy Subjects in a Dengue Human Challenge Model
Official title: A Phase 1, Double-blind, Randomized, Placebo-controlled Study to Assess the Antiviral Activity and Safety of AT-752 in a Dengue Human Challenge Model
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Dengue
Lead sponsor: Atea Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-09
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the safety and antiviral activity of AT-752 in healthy subjects in a Dengue Human Challenge Model

Detailed description: A Phase 1, double-blind, randomized, placebo-controlled study to assess the antiviral activity and safety of AT-752 in a Dengue Human Challenge Model

Eligibility criteria: Inclusion Criteria:

* Must agree to use protocol-specified methods of contraception
* Negative pregnancy test
* Willing to comply with the study requirements and to provide written informed consent

Exclusion Criteria:

* Pregnant or breastfeeding
* Abuse of drugs
* Other clinically significant medical conditions

Primary outcomes:
measure: Mean quantitative RNAemia (peak and duration and area under the plasma concentration versus time curve [AUC])
timeFrame: Day 2 until 28 days post virus inoculation
Secondary outcomes:
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: Atea Study Site
state: New York
Study officials:
References:
Clinical trial NCT03376022: Attitudes and Knowledge of Oral Health Among Nursing Personnel
Official title: Attitudes and Knowledge of Oral Health Among Nursing Personnel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knowledge, Attitudes, Practice
Attitude
Oral Health
Keywords: Attitudes
Knowledge
Oral Health
Nursing personnel
Lead sponsor: Dalarna County Council, Sweden
Sponsor class: OTHER
First posted: 2017-12-18
Enrollment: 4500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All nursing personnel in nursing home for elderly in the County of Dalarna Sweden.

Brief summary: Oral Health care has been shown to have low priority among nursing personnel, especially among personnel with shorter education.

Detailed description: As the population gets older and keep their natural teeth high up in age, in most cases throughout life, it is of importance to help the older maintain a good oral health when the cognitive functions and physical ability decreases. In 1999, a new dental care system was introduced with the aim to offer elderly with long-term need for extensive care, home visits for oral health assessment and, if necessary, be offered the necessary dental care. The aim was also to offer nursing personnel education and training in dental health and oral care, in order to provide and perform oral care. The effect of the education program has never been evaluated.

Eligibility criteria: Inclusion Criteria:

* Nursing personnel in nursing home for elderly
* Must be able to read and understand Swedish

Exclusion Criteria:

- None

Primary outcomes:
measure: Attitudes to Oral Health and oral care
timeFrame: February 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Falun
country: Sweden
facility: Kristina Edman
state: Dalarna
Study officials:
affiliation: Dalarna Public Dental Health
name: Kristina A Edman, PhD
role: PRINCIPAL_INVESTIGATOR
References: