louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04044222: A Study to Evaluate the Efficacy and Safety of a Sintilimab Plus ICE Regimen Versus ICE Regimen in Classic Hodgkin's Lymphoma Patients (cHL) Who Have Failed First-line Standard Chemotherapy
Official title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of a Sintilimab Plus ICE Regimen Versus a Placebo Plus ICE Regimen in Classic Hodgkin's Lymphoma Patients With First-line Standard Chemotherapy Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Classic Hodgkin's Lymphoma
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2019-08-05
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This phase III trial studies the side effects of sintilimab to see how well it works when given together with ifosfamide, carboplatin, and etoposide in treating patients with classic Hodgkin lymphoma that does not respond to first-line standard chemotherapy.

Detailed description: randomized, double-blind, two arms , multicenter

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent
2. Histopathologically confirmed cHL
3. Failed first-line standard combination chemotherapy
4. One measurable lesion (Lugano 2014)
5. Eastern Cooperative Oncology Group (ECOG) of 0-1
6. Male or female aged ≥18 years
7. Patients must have adequate organ and bone marrow function

Exclusion Criteria:

1. Patients must not have known central nervous system (CNS) involvement
2. Patients must not have had prior exposure to any immune checkpoint inhibitors including anti-PD-L1 agents, anti-PD-L2 agents, or anti-CTLA-4 monoclonal antibodies
3. Patients may not simultaneously participate in another interventional clinical study
4. Patients may not receive any other investigational agents within 4 weeks of study registration
5. Patients may not receive any other form of immunosuppressive therapy within 4 weeks prior to the first dose of study drug
6. Patients may not receive live attenuated vaccines within 4 weeks prior to the first dose of study drug (or plan to receive live attenuated vaccines during the study period)
7. Patients with known immunodeficiency are ineligible
8. Patients with known active TB (Bacillus tuberculosis) are ineligible
9. Patients must not have had prior allogeneic stem cell transplantation or allogeneic organ transplantation
10. Patients must not be pregnant or breastfeeding

Primary outcomes:
measure: PFS
timeFrame: 44months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
Study officials:
References:
Clinical trial NCT00310622: Assessment of HyperQ Signal for Detecting Ischemia During Dobutamine Stress ECG
Official title: An Assessment of the HyperQ Signal for Detecting Ischemia During Dobutamine Stress Echocardiography (DSE)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Myocardial Ischemia
Keywords: HyperQ
Ischemia
dobutamine
Lead sponsor: BSP Biological Signal Processing Ltd.
Sponsor class: INDUSTRY
First posted: 2006-04-04
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to verify the ability of the HyperQ signal to detect Dobutamine induced Ischemia. The gold standard for ischemia will be the results of Angiography if performed, or Echocardiographic imaging, which was performed during the test.

Detailed description: Subjects referred for Dobutamine Stress Echocardiography who will sign an Informed consent form will go through the test. High resolution ECG from 12 leads will be recorded using BSP's HyperQ system before, during and following the Echo testing. This wil be done without interfering or affecting any aspect of the normal procedure. Standard Protocol will be used with standard test termination indications.

The Diagnostic stage will include analysis of the hyperQ signal, aiming to classify results as ischemic or non-ischemic.

The HyperQ data will be compared to DSE results which will be used as the "gold standard" for this study unless Angiography results are obtained.

An additional comparison evaluation will be performed to assess the advantage of the HyperQ results on the ST-changes results obtained from conventional ECG.In addition all recruited subjects will be followed for up to 12 months.During this period a phone call will be performed every 3 months to evaluate cardiac status, hospitalization and especially Angiography procedures.

Eligibility criteria: Inclusion Criteria:

* Subject referred to dobutamine stress Echocardiography
* Subject signed informed consent

Exclusion Criteria:

* Subjects with implantable Pacemakers or Defibrillators
* Subjects with Wolff-Parkinson-White Syndrome

Primary outcomes:
measure: HyperQ Signal recorded during the DES Test
Secondary outcomes:
measure: DES Outcome/ Angiography
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Cardiology Department, Shaarey Zedek Hospital
Study officials:
affiliation: Shaarey Zedek Hospital, Jerusalem, Israel
name: David Rosenmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00738322: To Study Safety, Tolerability and Pharmacokinetics of AZD1305 in Healthy Male Japanese Subjects
Official title: A Single-Centre, Single-Blind, Randomised, Placebo-Controlled, Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics After Single Ascending Intravenous Doses of AZD1305 in Healthy Male Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: AZD1305
safety
pharmacokinetics
single ascending doses
Japanese
male
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-08-20
Enrollment: 36
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose is to study the safety of AZD1305, how AZD1305 is tolerated and how the medication is metabolised by the body ( how it is taken up into the body, distributed around the body and disappears from the body) in healthy Japanese males.


Eligibility criteria: Inclusion Criteria:

* A body mass index (BMI=weight/height2) of 19 to 27 kg/m2
* Japanese males

Exclusion Criteria:

* ECG findings outside normal reference ranges.
* Potassium outside normal reference ranges.

Primary outcomes:
measure: Safety by assessment of adverse events, ECG variables, BP, pulse rate, physical examination, laboratory variables, body temperature and body weight
timeFrame: During the study
Secondary outcomes:
measure: Pharmacokinetic variables
timeFrame: During the dosing visits
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D, Mölndal, Sweden
name: Helen Lunde, MD
role: STUDY_DIRECTOR
affiliation: Kyushu Clinical Pharmacology Research Clinic, Fukuoka, Japan
name: Kyoko Matsuguma, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01917422: Clinical Specimens Testing Program of Dengue Antigen Detection Reagents
Official title: Clinical Specimens Testing Program of Dengue Antigen Detection Reagents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dengue Fever
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2013-08-06
Enrollment: 195
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The samples are obtained from the Kaohsiung Medical University Chung-Ho Memorial Hospital in Kaohsiung, Taiwan.

Brief summary: Dengue virus serological reagent, included antigen and antiserum, is a serum test for identification of serum antibodies to dengue virus.

Detailed description: The developed assay helps to diagnose diseases caused by this virus and to provide information on disease epidemiology. This virus is mainly transmitted by mosquito bites to people and will make flu-like symptoms, including fever, fatigue, cough and headache, which can cause severe hemorrhagic dengue.

Eligibility criteria: Inclusion Criteria:A total of 95 cases and 100 controls (suspected cases(\>50 %) and normal subjects) are expected to enroll.

1. Case group: adults having a medical visit or admission due to dengue / dengue hemorrhagic fever / dengue shock syndrome, and medical care of by (defined by CDC). Any of the following positive test results for the case of 100 adults.

   1. clinical specimens (blood) isolated and identified dengue virus.
   2. clinical specimens positive for molecular detection of nucleic acids.
   3. serological antigen (referring to non-structural proteins of dengue virus non-structural protein 1, NS1) testing positive (based on the test of Bio-Rad DENGUE NS1 Ag STRIP).
   4. paired serum (restored period and acute phase), the dengue virus specific immunoglobulin M or immunoglobulin G antibodies or negative or ≧ 4 times increase.
2. Suspected cases: adults having medical visits or admissions due to infectious disease, but their NS1 (based on the test of Bio-Rad DENGUE NS1 Ag STRIP), immunoglobulin G,immunoglobulin M, real time-Polymerase chain reaction testing were negative.
3. Control group: adults without having medical visits or admissions due to Fever. - Exclusion Criteria:non-adult case -

Primary outcomes:
measure: Clinical specimens testing program of dengue antigen detection reagents
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Kaoshiung
country: Taiwan
facility: Kaoshing Medical University Chung-Ho Memorial Hospital
Study officials:
References:
Clinical trial NCT00000322: Tyrosine for Methamphetamine Dependence - 1
Official title: Tyrosine for Methamphetamine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Amphetamine-Related Disorders
Keywords: amphetamine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 1999-09-21
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate efficacy of tyrosine as a treatment for methamphetamine dependence in an outpatient treatment setting providing group psychosocial interventions. Examine effect of tyrosine on abstinence, retention in treatment, and craving."

Detailed description: Evaluate efficacy of tyrosine as a treatment for methamphetamine dependence in an outpatient treatment setting providing group psychosocial interventions. Examine effect of tyrosine on abstinence, retention in treatment and craving.

Eligibility criteria: Inclusion Criteria:

18-65 years of age. Able to provide informed consent. Desire to reduce/eliminate methamphetamine use. Used within the past two weeks. Meet DSM criteria for methamphetamine dependence.

Exclusion Criteria:

No dependence (within the past 12 months) for other durgs except nicotine. No history or family history of tyrosine intolerance.

Primary outcomes:
measure: Craving
measure: Drug use
measure: Retention
measure: Functioning
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Haight Ashbury Free Clinics
state: California
Study officials:
affiliation: Haight Ashbury Free Clinics
name: Gantt Galloway, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01172522: Topical Treatment of Under Eye Dark Circles and Swelling
Official title: A Pilot Randomized Double Blind Study to Assess the Safety and Efficacy of 1% Ibuprofen/ 1%Fexofenadine Topical Cream for the Treatment of Dark Circles Under the Eyes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Edema
Keywords: Under eye dark circles
Under eye puffiness
Lead sponsor: The Connecticut Sinus Center, PC
Sponsor class: OTHER
Collaborators: name: TKL Research, Inc.
First posted: 2010-07-29
Enrollment: 30
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: This study examines topical treatment of under eye circles and swelling.

Detailed description: This study examines topical treatment of under eyes dark circles and under eye swelling.

Eligibility criteria: Inclusion Criteria:

* Under eye dark circles and swelling

Exclusion Criteria:

* Under age 18
* Allergy to tested medicines

Primary outcomes:
measure: Number of Participants Who Showed Improvement in Under Eye Swelling and Dark Circles Relative to Baseline Per Intervention
timeFrame: Baseline, weekly, and end of study +7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Paramus
country: United States
facility: TKL Research
state: New Jersey
Study officials:
affiliation: The Connecticut Sinus Center, PC
name: Edward M Lane, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03025048: A Holistic Dietary Intervention for Persons With Spinal Cord Injury
Official title: PILOT: A Holistic Dietary Intervention for Persons With Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injuries
Lead sponsor: Sunnaas Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2017-01-19
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients With long-standing spinal cord injury (\> 2 years after injury)

Brief summary: People with spinal cord injury are at increased risk for overweight and obesity, type 2 diabetes, cardiovascular disease and decreased quality of life compared With able bodied.

This pilot aims to assess the impact of a nutrition intervention that combines several methods to help people change their lifestyle.

The pilot project combines individual interviews and personal lifestyle goals (diet) with group classes for people with long-standing spinal cord injury.

In addition to nutrition theory and practical exercises for diet-planning, motivational interviewing and mindfullness are incorporated into the course. The course is interdisciplinary, but is led primarily by a dietitian. Data is collected before the course starts and right after the 9-week course ends. The measurements involves self-perceived quality of life, food diary, weight, waist circumference and body composition (measured by BIA and DXA).


Eligibility criteria: Inclusion Criteria:

* \>18 years
* Long-standing Spinal Cord Injury (\> 2 years after injury)
* Motivated for lifestyle change

Primary outcomes:
measure: Body composition
timeFrame: Short-term: 9 weeks
Secondary outcomes:
measure: Diet behaviour
timeFrame: Short-term: 9 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01926548: to Evaluate the Pharmacokinetics(Cmax, Auc) of CJ Imatinib Mesylate Tablet 200mg x 1 Compared With Gleevec Film-coated Tablet 100mg x 2 in Healthy Male Volunteers
Official title: Open-label, Randomized, Single-dose, 2-way Crossover Study to Evaluate the Pharmacokinetics(Cmax, Auc) of CJ Imatinib Mesylate Tablet 200mg x 1 Compared With Gleevec Film-coated Tablet 100mg x 2 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Pharmacokinetics
Safety
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2013-08-21
Enrollment: 28
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study is designed to evaluate the pharmacokinetics of CJ Imatinib mesylate tablet 1 x 200mg compared with Gleevec film-coated tablet 2 x 100mg in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Male volunteers in the age between 20 and 55 years old
* Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data
* Body Mass Index (BMI) in the range of 18.5 to 27 kg/m2
* Available for the entire study period
* Willing to adhere to protocol requirements and sign a informed consent form

Exclusion Criteria:

* History of clinically significant hepatic, renal, neurology, psychiatric, pulmonary, endocrine, hematologic, cardiovascular disease
* Clinically significant vital sign

  * SBP(Systolic Blood Pressure) ≤ 90 mmHg or SBP ≥ 140 mmHg
  * DBP(Diastolic Blood Pressure) ≤ 60 mmHg or DBP ≥ 100 mmHg
* History of surgery except or gastrointestinal disease which might significantly change absorption of medicines
* History of clinically significant allergies, including imatinib
* Clinical laboratory test values are outside the accepted normal range

  * AST(ASpartate Transaminase), ALT(ALanine Transaminase)( \> 1.5 times to normal range
  * Estimated GFR(Glomerular Filtration Rate) \< 80 mL/min
* History of caffeine, alcohol, smoking abuse

  * caffeine \> 4 cups/day
  * grapefruit juice \> 4 cups/day
  * smoking \> 20 cigarettes/day
  * alcohol \> 140g/week
* Participated in a previous clinical trial within 3 months prior to dosing
* Donated blood within 60 days prior to dosing
* Use of prescription only medicine and oriental medicine within the 14 days before dosing or use of non-prescription medicine within the 10 days before dosing
* Subjects considered as unsuitable based on medical judgement by investigators

Primary outcomes:
measure: maximum concentration, Area under the concentration-time curve from zero to infinity
timeFrame: Blood sampling up to 72hs post dose(16 times).
Secondary outcomes:
measure: Time to peak concentration, t1/2, Area under the concentration-time curve from zero to infinity
timeFrame: Blood sampling up to 72hs post dose(16 times).
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT00140348: Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine
Official title: A Phase I/II Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine in Patients With Metastatic Hormone-Refractory Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Keywords: Prostate
Cancer
Advanced Prostate Cancer
Metastatic
Hormone-refractory
GVAX
Vaccine
Allogeneic cells
Lead sponsor: Cell Genesys
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate clinical and laboratory safety in patients receiving 4 different doses of GVAX® Prostate Cancer Vaccine in order to determine a maximum tolerated dose.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of adenocarcinoma of the prostate
* Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy
* Detectable metastases
* ECOG performance status of 0 or 1

Exclusion Criteria:

* Transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer
* Significant cancer related pain
* Prior gene therapy, chemotherapy, or immunotherapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Laguna Woods
country: United States
facility: South Orange County Medical Research Center
state: California
city: San Francisco
country: United States
facility: UCSF
state: California
city: Tarzana
country: United States
facility: West Coast Clinical Research
state: California
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Urbana
country: United States
facility: Carle Cancer Center
state: Illinois
city: Fort Wayne
country: United States
facility: Northeast Indiana Research
state: Indiana
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
city: Philadelphia
country: United States
facility: Fox Chase cancer Center
state: Pennsylvania
city: San Antonio
country: United States
facility: Urology San Antonio
state: Texas
city: Seattle
country: United States
facility: Virginia Mason Med. Crt.
state: Washington
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
Study officials:
References:
Clinical trial NCT00685048: Brief Therapies for Problem Gambling Substance Abusers
Official title: Brief Therapies for Problem Gambling Substance Abusers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gambling
Keywords: Gambling
Brief Therapies
Substance Abuse
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2008-05-28
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This project evaluates the efficacy of brief interventions for individuals seeking treatment for substance use disorders who also have gambling problems. In total, 220 problem gambling substance abusers will be randomized to one of three conditions: (a) a control condition consisting of 10 minutes of psychoeducation about gambling, (b) 10 minutes of brief advice about problem gambling and how to reduce it, or (c) four session of motivational and cognitive-behavioral therapy. Gambling, substance use and psychosocial problems will be assessed using standardized instruments at pre-treatment, month 2, 5, 8, 12, 16, 20 and 24-month follow-up evaluations.


Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* current (past-year) DSM-IV criteria for alcohol, cocaine, opioid or marijuana abuse or dependence
* score \>3 on the past-two month SOGS
* report an average of \>2 gambling days per month for the past 2 months; (e) spent an average of \>$50/month on gambling in the past 2 months
* English speaking
* sign informed consent.

Exclusion Criteria:

* have uncontrolled major psychiatric disorders other than substance use that require inpatient hospitalization (e.g., active bipolar disorder, psychosis, suicidality)
* desire specific gambling treatment or are currently receiving treatment for gambling
* have severe cognitive impairment
* read below 5th grade level
* plan to relocate \>100 miles or are likely to be incarcerated

Primary outcomes:
measure: dollars and days gambled per month
timeFrame: baseline and each follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
Study officials:
affiliation: UConn Health Center
name: Nancy M Petry, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: