louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02724332: Adjuvant Anti-Recurrence Treatment With Rapamycin on Early-stage HCC
Official title: A Randomized Controlled Study on the Effect of Adjuvant Anti-recurrence Treatment With Rapamycin on Early-stage HCC With Overexpression of ASPH After Radical Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatocellular Carcinoma
Rapamycin
Keywords: Aspartate beta hydroxylase
transcatheter arterial chemoembolization
Lead sponsor: Eastern Hepatobiliary Surgery Hospital
Sponsor class: OTHER
First posted: 2016-03-31
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the clinical effect of rapamycin combined with TACE on early-stage HCC with overexpression of ASPH after radical surgery using randomized controlled study and provide a new anti-recurrence treatment for HCC patients after operation.


Eligibility criteria: Inclusion Criteria:

1. Via clinical diagnosis and confirm it is primary liver cancer
2. Pathological evidence of HCC
3. Estimate tumor can gain treatment of curing operation
4. No evidence for extrahepatic metestasis
5. liver function ：Child-Pugh A/B
6. BCLC stage：0/1；TNM stage：Ⅰ

Exclusion Criteria:

1. reject to attend；
2. impossible to come to our hospital for physical examination regularly.
3. cancer epitome、seed focus、lymph node or distant metastasis
4. Blood clotting function hindrance; 5, Patients with other diseases which may affect the treatment mentioned.

Primary outcomes:
measure: Overall Survival
timeFrame: 3 years
Secondary outcomes:
measure: Time to recurrence
timeFrame: 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eastern hepatobilliary surgery hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT01189032: Late Phase II Confirmatory Study of DE-089 Ophthalmic Solution in Patients With Dry Eye
Official title: Dose-Response Study of DE-089 Ophthalmic Solution in Patients With Dry Eye -Late Phase II Confirmatory Study-
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye
Lead sponsor: Santen Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2010-08-26
Enrollment: 320
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT

Brief summary: Dose response related to efficacy and safety of DE-089 ophthalmic solution are examined in patients with dry eye, using a multicenter, randomized, double-blind, parallel group comparison study, and the optimal concentration is determined.


Eligibility criteria: Inclusion Criteria:

* Those who show:

  * Keratoconjunctival disorder confirmed with vital dye staining
  * Abnormal Schirmer score results

Exclusion Criteria:

* Eye disease that needs therapy other than that for dry eye
* Those who need to wear contact lenses during the clinical study

Primary outcomes:
measure: Mean Change in Fluorescein Staining Score From Baseline
timeFrame: Baseline and 4-week (discontinued(LOCF))
Secondary outcomes:
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Santen study sites
Study officials:
References:
Clinical trial NCT00537732: Omeprazole and Reflux Disease - Improvement of Clinical Outcome by Genotype-adjusted Dosing
Official title: Omeprazole and Reflux Disease - Improvement of Clinical Outcome by Genotype-adjusted Dosing
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Gastroesophageal Reflux
Keywords: gastro-oesophageal reflux disease
Lead sponsor: Robert Bosch Gesellschaft für Medizinische Forschung mbH
Sponsor class: OTHER
First posted: 2007-10-01
Enrollment: 68
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with gastroesophageal reflux disease (GERD) are either treated for 4 weeks with a standard dose (20mg) of omeprazole, a drug of first choice, or by an individualized dosing (20 or 60mg/day) according how fast the patient can metabolize (eliminate) the drug. The individual elimination capacity is genetically controlled and therefore all patients will be genotyped prior to therapy.


Eligibility criteria: Inclusion Criteria:

* Patients with GERD grade A and B (mild to moderate severe disease) diagnosed by routine endoscopy will be recruited in different clinical and ambulant centres of gastroenterology; written informed consent is obligatory
* Range of Age: 20-70
* BMI: 20-30

Exclusion Criteria:

* Patients who are allergic to proton-pump inhibitors or show incompatibility
* Patients who have lactase deficiency
* Patients who have severe chronic disease
* Patients who participated in another study during the last three months
* Patients who are pregnant

Primary outcomes:
measure: endoscopic healing rate in patients with GERD after 4 weeks of individualised dosing of omeprazole (according to metabolic capacity of the patient)
timeFrame: 4 weeks
Secondary outcomes:
measure: clinical healing rate in patients with GERD after 4 weeks of individualised dosing of omeprazole
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology
state: Baden-Württemberg
Study officials:
affiliation: Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology
name: Matthias Schwab, Prof, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Klotz U, Schwab M, Treiber G. CYP2C19 polymorphism and proton pump inhibitors. Basic Clin Pharmacol Toxicol. 2004 Jul;95(1):2-8. doi: 10.1111/j.1600-0773.2004.pto950102.x.
Clinical trial NCT03807232: Predictive Factors, Demographics and Mortality for ARDS in Burn Patients
Official title: Predictive Factors, Demographics and Mortality for ARDS in Burn Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ARDS, Human
Burns
Lung Diseases
Keywords: ARDS, Human
Burns
Lung Diseases
Risk Factors
Retrospective Studies
Decision Support Techniques
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2019-01-16
Enrollment: 400
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients treated at the Burns Intensive Care Unit (BICU) of the University Hospital Zurich (USZ) between January 2004 and December 2009

Brief summary: This retrospective study characterizes the clinical course and identifies four independent predictors of Acute Respiratory Distress Syndrome (ARDS) after burn injury (post-burn ARDS; pbARDS). In addition, a clinically useful prognostic score for pbARDS is introduced (ARDS burn score), which was derived from these independent predictors. The newly developed score may be helpful for the development of specific treatment strategies.

Detailed description: Rationale:

Acute Respiratory Distress Syndrome (ARDS) after burn injury (post-burn ARDS; pbARDS) is a severe complication associated with a mortality of up to 44%. To date, only few studies have been published on the clinical course and predictive factors of pbARDS.

Objectives:

To characterize the clinical course of pbARDS, to identify relevant predictors, including the development of a prognostic score, and to examine outcome parameters such as mortality and hospitalization days.

Methods:

A retrospective analysis of 400 patients admitted to the Burns Intensive Care Unit of the University Hospital Zurich from 2004 to 2009 was performed. Multivariate logistic regression was used to determine independent risk factors for pbARDS. A prognostic score was developed, which was tested with leave-one-out-cross-validation and Receiver Operating Characteristic (ROC) curves.

Eligibility criteria: Inclusion Criteria:

all patients treated at the Burns Intensive Care Unit (BICU) of the University Hospital Zurich (USZ) between January 2004 and December 2009.

Exclusion Criteria:

Exclusions were made because of incomplete or unavailable data, re-hospitalization due to complications of previous burns, and the initial decision not to resuscitate due to unfavorable prognosis.

Primary outcomes:
measure: Incidence of post-burn ARDS
timeFrame: 6 years
measure: Clinical course of post-burn-ARDS
timeFrame: 6 years
measure: predictors of post-burn ARDS
timeFrame: 6 years
Secondary outcomes:
measure: to examine outcome parameter mortality
timeFrame: 6 years
measure: to examine outcome parameter hospital stay
timeFrame: 6 years
Other outcomes:
Locations:
Study officials:
affiliation: Universitätsspital Zürich
name: Pietro Giovanoli, Prof. Dr. med.
role: STUDY_CHAIR
References:
Clinical trial NCT06548932: A Study to Evaluate the Safety, Tolerance, PK and PD Parameters of GZR33 and GZR101 in Healthy Male Adult Subjects
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerance, PK and PD Parameters of Single Dose Escalation of GZR33 and Single Administration of GZR101 in Healthy Male Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Gan and Lee Pharmaceuticals, USA
Sponsor class: INDUSTRY
First posted: 2024-08-12
Enrollment: 52
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo-controlled, single dose phase I clinical study. It is divided into two parts: part A , a single ascending dose assessment of GZR33, and partB, a single dose evaluation of GZR101.


Eligibility criteria: Inclusion Criteria:

* 1. Voluntarily participated in the study and signed the informed consent form (ICF);
* 2. Chinese healthy male adult subjects, aged 18-45 years old (both inclusive) at the time of signing the ICF;
* 3.Body mass index \[BMI= weight (kg)/height (m) 2\] at screening between 19.0 and 24.0 kg/m2, inclusive, a body weight ≥50 kg；

Exclusion Criteria:

* 1. Abnormalities assessed by the investigator to be clinically significant while screening: vital signs, physical examination, laboratory examination, anterior and lateral chest X-ray and 12-lead ECG;
* 2. Known severe allergy (such as allergy to more than 3 allergens, allergic asthma affecting the lower respiratory tract, and allergy requiring glucocorticoid treatment) or known history of allergy to the drug ingredients used in this study;
* 3. Participants who have smoked more than 5 cigarettes per day within 3 months before screening, smoked within 48 h before using the investigational drug, or impossibly stopped using any tobacco products during the test;
* 4.History of drug abuse or drug abuse before screening, or positive results in alcohol testing and urine drug screening (morphine, methamphetamine, methadone, phencycldine piperidine, tetrahydrocannabinol acid, cocaine) while screening;
* 5. Human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or treponema pallidum antibody positive.

Primary outcomes:
measure: Incidence of adverse events (AE)
timeFrame: From Predose to Day14 after a single dose
Secondary outcomes:
measure: GIRmax
timeFrame: From 0 hours to 24 hours after a single dose
measure: AUCGZR33,0-24 h
timeFrame: From Predose to Day8 after a single dose
measure: AUCIAsp，0-12 h
timeFrame: From 0 hours to 12 hours after a single dose
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Study Site 01
Study officials:
affiliation: Gan & Lee Pharmaceuticals.
name: Clinical Transparency
role: STUDY_DIRECTOR
References:
Clinical trial NCT03646032: Sexually Active Adolescent Focused Education
Official title: An mHealth Education Intervention for Encouraging STI Testing Uptake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Risk Behaviors
Keywords: Mobile dating simulation game
Sexual education
HIV
STI
Consent
Lead sponsor: Benten Technologies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Alabama at Birmingham
name: Medstar Health Research Institute
First posted: 2018-08-24
Enrollment: 178
Sex: ALL
Minimum age (years): 15
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: SAAFE will be pilot tested in 2 geographically distinct areas (Washington, DC and Deep South) with 100 participants from each site to 1) primarily assess the efficacy of improved self-efficacy, knowledge about HIV/STIs and perception of sexual risks by AAAs, and (2) secondarily detect intention to be tested for STIs and to change sexual risk behavior (i.e., use a condom).

Detailed description: A total of 200 African American adolescents (AAA) males and females will be recruited from Washington, DC (n=100) and Birmingham, Alabama (n=100). At both data collection sites, participants will be randomly assigned to one of two groups during the pilot. The two groups are:

1. Intervention group (n=100) - will consist of 50 AAA males / 50 AAA females randomly selected participants who will receive a download of the SAAFE game and play for at least 30 minutes and as long as an hour, if desired.
2. Control group (n=100) - will consist of 50 AAA males / 50 AAA females randomly selected participants. This group will receive dating sim game (called Choices). They will also receive pamphlets that provide information on the testing location and care if they have HIV/STI.

Eligibility criteria: Inclusion Criteria:

* African American female or male
* Between 15-21 years of age

Exclusion Criteria:

* Pregnant women
* The first 6 weeks post-partum
* Adolescents younger than 15

Primary outcomes:
measure: Knowledge about HIV/STIs
timeFrame: 1 month
Secondary outcomes:
measure: Perception of sexual risks
timeFrame: 1 month
measure: Intention to be tested for STIs
timeFrame: 1 month
measure: Intention to use a condom
timeFrame: 1 month
measure: Consent
timeFrame: 1 month
measure: System Usability and Acceptability Metrics
timeFrame: 1 month
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
city: Washington
country: United States
facility: Medstar Washington Hospital Center
state: District of Columbia
Study officials:
affiliation: Benten Technologies, Inc.
name: Tony Ma, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01750632: Subcapsular Orchiectomy in Men With Klinefelter Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Klinefelter Syndrome
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Aarhus University Hospital
First posted: 2012-12-17
Enrollment: 14
Sex: MALE
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Men with Klinefelter syndrome undergo unilateral subcapsular ochiectomy, and the removed testicular tissue is examined for presence of sperm and cryopreserved in small pieces for fertility treatment and scientific purposes. Prior to operation blood samples are frozen in a biobank.


Eligibility criteria: Inclusion Criteria:

* Klinefelter
* 15-40 years of age

Exclusion Criteria:

* inability to understand the study

Primary outcomes:
measure: Presence of testicular sperm
timeFrame: Between 1 and 6 months
Secondary outcomes:
measure: Clinical pregnancy rate after ICSI with retrieved testicular sperm
timeFrame: participants will be followed for the duration of fertility treatment, an expected average of 6 months
Other outcomes:
measure: Predictive value of FSH and other hormones for the presence of testicular sperm
timeFrame: Between 1 and 6 months
Locations:
city: Odense
country: Denmark
facility: Fertility Clinic, Odense University Hospital
Study officials:
References:
citation: Fedder J, Gravholt CH, Kristensen SG, Marcussen N, Engvad B, Milton AM, Andersen CY. Testicular Sperm Sampling by Subcapsular Orchiectomy in Klinefelter Patients: A New Simplified Treatment Approach. Urology. 2015 Oct;86(4):744-50. doi: 10.1016/j.urology.2015.06.044. Epub 2015 Aug 4.
Clinical trial NCT05251532: The Efficacy of Distortion Banding on Outcome Measures in Children With Cerebral Palsy
Official title: The Efficacy of Distortion Taping on Balance, Performance, Gait, Spasticity and Quality of Life in Ankle Varus Deformity in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy, Spastic
Keywords: Cerebral palsy
Kinesio taping
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2022-02-22
Enrollment: 32
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised Controlled Trial
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare the conventional rehabilitation program and the distortion taping applied with Kinesio Tex tape in addition to conventional rehabilitation in children with hemiplegic or monoplegic cerebral palsy with ankle varus deformity.

Detailed description: Conventional rehabilitation practices will be applied to the control group. In addition to Kinesio Tex tape distortion taping, conventional rehabilitation will be applied to the intervention group. It is aimed to evaluate the patients' balance, quality of life, performance test, spasticity level and gait quality.

Eligibility criteria: Inclusion Criteria:

* Children with cerebral palsy aged 4-12 years with unilateral involvement who are hemiplegic or monoplegic
* Cases with Gross Motor Function Classification (GMFCS) level 1 or 2
* Understanding simple commands and signing the consent form

Exclusion Criteria:

* Presence of equinus deformity
* Situations that may prevent assessments or communication
* Lack of cooperation during work
* Presence of surgery that may affect assessments, such as joint freezing
* Presence of botulinum toxin administration in the last 6 months
* Development of an allergic reaction on the skin to the tape

Primary outcomes:
measure: TUG
timeFrame: Change from Baseline TUG at 3 days
measure: SLS
timeFrame: Change from Baseline SLS at 3 days
measure: Modified Ashworth Scale (MAS)
timeFrame: Change from Baseline MAS at 3 days
measure: WGS
timeFrame: Change from Baseline WGS at 3 days
measure: CHQ
timeFrame: Change from Baseline CHQ at 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Muğla
country: Turkey
facility: Fethiye Private Son Atılım Special Education and Rehabilitation Center
state: Fethiye
Study officials:
affiliation: Muğla Sıtkı Koçman University
name: Ahmet İmerci, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ege University
name: İsmet Tümtürk, BSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01124032: A Double Blind Crossover Study on the Effect of Methylphenidate on Decision-making Ability of Adults With ADHD Compared to Healthy Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ADHD
Lead sponsor: Shalvata Mental Health Center
Sponsor class: OTHER
Collaborators: name: Technion, Israel Institute of Technology
First posted: 2010-05-14
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study assesses the effect of Ritalin on working memory,attention,and decision-making measures in adults with ADHD and compares it to its effect on healthy adults, in a double-blind crossover design.We hypothesize that Ritalin will result in better performance in all measures,and that the improvement will be greater in the ADHD group.


Eligibility criteria: Inclusion Criteria:

* adults in the age of 21-50

Exclusion Criteria:

1. People diagnosed with a clinical disorder other than ADD/ADHD that may impair their performance in the tasks used in the study.
2. People for whom there is a contra-indication for consuming Ritalin.
3. Pregnant women and nursing women;

Primary outcomes:
measure: TOVA score
timeFrame: assessed twice, separated by 1-2 weeks.
measure: IGT score
timeFrame: assessed twice, separated by 1-2 weeks
measure: FPGT score
timeFrame: assessed twice, separated by 1-2 weeks
measure: SWM score
timeFrame: assessed twice, separated by 1-2- weeks
measure: digit span score
timeFrame: assessed twice, separated by 1-2- weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hod Hasharon
country: Israel
facility: Shalvata Mental Health center
Study officials:
References:
citation: Agay N, Yechiam E, Carmel Z, Levkovitz Y. Non-specific effects of methylphenidate (Ritalin) on cognitive ability and decision-making of ADHD and healthy adults. Psychopharmacology (Berl). 2010 Jul;210(4):511-9. doi: 10.1007/s00213-010-1853-4. Epub 2010 Apr 28.
Clinical trial NCT00388232: Prevalence of COPD: First Epidemiological Data From a Large Region of Turkey
Official title: Inonu University, The Department of Pulmonary Medicine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD Prevalance
Keywords: COPD
prevalence
smoke
biomass
occupational
Malatya
Turkey
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2006-10-16
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Time perspective: OTHER

Brief summary: The study was designed to obtain some baseline data on COPD in Malatya region of Turkey.

Detailed description: Sixty clusters from urban and rural regions were randomly selected. Ten and seven consecutive houses were included in the study from each urban and rural cluster respectively. A validated questionnaire on epidemiology of COPD was completed for each household over 18 by a pulmonary physician. Each subject performed the standard spirometric measurement and early bronchodilation testing.

Eligibility criteria: Inclusion Criteria:

* All households over 18 were included in the study

Exclusion Criteria:

* Age \<18 years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Inonu University Department of Pulmonary Medicine
name: Hakan Gunen, Associate Professor
role: STUDY_CHAIR
References: