louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00194064: Pilot Study Evaluating the Safety and Efficacy of Open-Label Olanzapine
Official title: Pilot Study Evaluating the Safety and Efficacy of Open-Label Olanzapine Monotherapy in Treatment Refractory Bipolar Disorder Mania
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Bipolar Disorder
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2005-09-19
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Inpatient Study Evaluating the Safety and Efficacy of Open-Label Olanzapine Monotherapy in Treatment Refractory Bipolar Mania: This study recruits adult subjects who are diagnosed with Bipolar I Disorder and presently experiencing an episode of mania. Patients must be willing to spend initial 7 days in the hospital to observe response to medication. Patients must be refractory (intolerant or non-responsive) to treatment with lithium and valproate or carbamazepine. Patients receive study-related care at no cost. This study is sponsored by Eli Lilly and Company.


Eligibility criteria: Inclusion Criteria:

* The subject satisfied Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for a primary diagnosis of Bipolar Disorder, most recently manic
* The patient is willing to be hospitalized on an inpatient psychiatric unit for a minimum of seven (7) days.
* Subject has been treated with lithium in the past.
* Subject has been treated with divalproex or carbamazepine in the past.
* Subject has been treated with Haldol or haloperidol in the past.

Exclusion Criteria:

* Subjects lacks the capacity to provide informed consent
* Subject is a serious suicide risk or has medically unstable conditions as judged by the investigators
* Subject has been dependent on a drug (other than nicotine or caffeine) in the last three (3) months.

Primary outcomes:
measure: Young Mania Rating Scale (YMRS)
timeFrame: Change from Baseline to End of Study
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
Study officials:
affiliation: Case Western Reserve University / University Hospitals of Cleveland
name: Joseph R Calabrese, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03107364: Trend in Hospital Lengths of Stay and Readmissions
Official title: Association Between Trend in Length of Stay and Risk of Readmission at Hospital After Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Trend in Hospital Lengths of Stay and Readmissions
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 100000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients operated for colorectal disease or hip fracture

Brief summary: Medical and surgical innovations have allowed to shorter length of hospital stay (LOS). We assume that hospitals with uncontrolled reduction in LOS may expose patients to unsafe care. At the institutional level, a dynamic analysis of LOS evolution over time could clarify the existence of a link with the risk of readmission.


Eligibility criteria: Inclusion Criteria:

* All patients who underwent elective colorectal surgery or urgent surgical procedure for hip fracture in French public and private hospitals from January 2014 to December 2016

Exclusion Criteria:

* Age \< 18 years old
* Death during the index stay

Primary outcomes:
measure: Unplanned hospital readmission with death, intensive care, or reoperation
timeFrame: 30 days
Secondary outcomes:
measure: Unplanned hospital readmission with death, intensive care, or reoperation
timeFrame: 3 months
measure: Unplanned hospital readmission with death, intensive care, or reoperation
timeFrame: 6 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon
Study officials:
affiliation: Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon
name: Antoine DUCLOS, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05504564: Genetic Biomarkers of Child Language Development in Taiwan: an Identification and Validation Study
Official title: Genetic Biomarkers of Child Language Development in Taiwan: an Identification and Validation Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Child Language
Keywords: language development
gene
whole-exome sequencing
body function and body structure
quality of life
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2022-08-17
Enrollment: 300
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Control and experimetn group

Brief summary: A study of the relation between genetic biomarkers and child language development in Taiwan.

Detailed description: The interaction between gene and environment (G×E) can be a very complicated process that influences child development. As a pilot study of child development biomarkers, this study investigates genes related to child language development and language disorder.

Eligibility criteria: Inclusion Criteria:

* Age 2-18 y/o
* Agree to sign informed consent

Exclusion Criteria:

* Central nervous system disease
* Neuromuscular Disorders
* Congenital Abnormality
* Genetic Disease
* Dysesthesia
* Hearing Impairment

Inclusion Criteria of Child with language disorder:

* Patients with Language Disorder
* Age 2-18 y/o
* Agree to sign informed consent
* Exclusion Criteria of Child with language disorder:
* Hearing Impairment

Inclusion Criteria of Adult:

* His or her child participated in this study, and gene abnormality was found.

Primary outcomes:
measure: Scores of cognitive function 1
timeFrame: baseline
measure: Scores of cognitive function (2 y/o to 6 y/o)
timeFrame: baseline
measure: Scores of cognitive function (6 y/o to 16 y/o)
timeFrame: baseline
measure: Scores of cognitive function 3
timeFrame: baseline
measure: Scores of language function 1
timeFrame: baseline
measure: Scores of language function 2
timeFrame: baseline
measure: Scores of general development
timeFrame: baseline
measure: Gene test 1
timeFrame: baseline
measure: Gene test 2
timeFrame: baseline
Secondary outcomes:
measure: Scores of participation(2-5 y/o)
timeFrame: baseline
measure: Scores of participation(>6 y/o
timeFrame: baseline
measure: Scores of activities
timeFrame: baseline
measure: Scores of quality of life
timeFrame: baseline
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memoria Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chia-Ling Chen, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03402464: Icotinib Combined With Dihydroaremisinin (DHA) Therapy in Patients With Advanced NSCLC
Official title: Icotinib Combined With Dihydroaremisinin (DHA) Therapy in Patients With Advanced Gradually Progressed NSCLC After First-line Icotinib: an Open-label, Single-arm, Multicenter Phase II Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: EGFR Positive Non-Small Cell Lung Cancer,Adenocarcinoma
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
Collaborators: name: Betta Pharmaceuticals Co., Ltd.
First posted: 2018-01-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study was to evaluate the safety, PFS and ORR of icotinib/dihydroaremisinin (DHA)-based combination therapy in EGFR-mutated, advanced NSCLC patients who have gradually progressed disease after first-line icotinib treatment.


Eligibility criteria: Inclusion Criteria:

1. Patients confirmed with stage IV lung adenocarcinoma by pathologic histology or cytology who can't accept surgery and radiotherapy
2. Male or female patients aged ≥18 years, life expectancy ≥ 12 weeks
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
4. Sensitive EGFR gene mutation(19/21)
5. Failed with first-line icotinib and have gradually progressed disease More than 6-month duration of first-line icotinib (from the first dosing to the imaging-confirmed progression; and discontinuation of icotinib is less than 14 days) No significantly increased tumor size compared with the final imaging evaluation

Exclusion Criteria:

1. Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease)
2. Female subjects should not be pregnant or breast-feeding
3. Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
4. Previous systemic anti-tumor therapy except for icotinib , including chemotherapy or targeted therapy ( including but not limited to monoclonal or antibodies, small molecule tyrosine kinase inhibitor, etc)
5. Tumor metastasis of the spinal cord, meninges or meningeal neoplasms confirmed by imaging or cerebrospinal fluid examination

Primary outcomes:
measure: Progress Free Survival
timeFrame: 18 months
measure: Objective response rate
timeFrame: 18 months
Secondary outcomes:
measure: Overall Survival
timeFrame: 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Ziping Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03358264: Effect of L-Citrulline Supplementation on Arginase Activity and Vascular Function in Diabetes
Official title: Effect of L-Citrulline Supplementation on Arginase Activity and Vascular Function in Type II Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Vascular dysfunction, L-citrulline, arginase
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2017-11-30
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Arginase has recently been implicated in an array of vascular conditions including atherosclerosis , hypertension and vascular complication of diabetes. In this study we will determine of L-citrulline; a natural amino acid that is known to have inhibitory effects on arginase activity, on vascular function in type 2 diabetic patients.

Detailed description: Vascular dysfunction is a major cause of morbidity and mortality in diabetic patients. The pathological process is characterized by impaired endothelial cell production of the vasodilator and antiplatelet adhesion factor nitric oxide (NO) and/or decreased NO bioavailability. NO is a major regulator of vascular tone and integrity. In endothelial cells, NO is produced by activity of endothelial NO synthase (eNOS) on its substrate L-arginine. Reduced availability of L-arginine to eNOS has been implicated in vascular dysfunction in diabetes and a variety of other disease conditions. Arginase, which metabolizes L-arginine to urea and ornithine, competes directly with NOS for L-arginine. Hence increases in arginase activity can decrease tissue and cellular arginine levels, reducing its availability to eNOS and decreasing No production. During diabetes, elevated levels of arginase can compete with NOS for available arginine thus reducing vascular NO. We have recently shown that arginase activity is elevated in diabetes. In this proposal we implement a method of flow mediate dilation (FMD) to assess vascular function in diabetic patients. We will study the relation of our vascular function findings with arginase activity levels. We propose that arginase activity measurements could be novel marker of vascular dysfunction in diabetes. The effect of the natural amino acid supplements (L-citrulline) on levels of arginase activity in diabetic patients and vascular function will also be studied.

Eligibility criteria: Inclusion Criteria:

Type 2 diabetes Diabetic state: HbA1c\>6

Exclusion Criteria:

-

Primary outcomes:
measure: arginase activity
timeFrame: 1 month
measure: Vascular function
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: The University of Jordan
Study officials:
References:
citation: Shatanawi A, Momani, MS. Plasma arginase activity is elevated in type 2 diabetic patients. Biomedical Research-India 28(9): 4102-4106, 2017
Clinical trial NCT01913964: Acetyl-L-Carnitine Supplementation During HCV Therapy With Pegylated Interferon-α2b Plus Ribavirin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Work Productivity and Activity Impairment in Workers With Chronic C Hepatitis
Fatigue in Workers With Chronic C Hepatitis
Fatigue
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2013-08-01
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the effects of Acetyl-L-Carnitine administration on work productivity, daily activity, and fatigue in subjects with chronic hepatitis C treated with Pegylated-Interferon-α2b and Ribavirin.


Eligibility criteria: Inclusion Criteria:

* workers who were 18 years of age or older
* Workers who were infected by HCV and had a quantifiable serum HCV RNA level (as determined by polimerase chain reaction, COBAS AmpliPrep/COBAS TaqMan - ROCHE)
* Cirrhotic workers with a Child-Pugh score less than 7

Exclusion Criteria:

* workers who had other liver diseases
* cancer
* severe jaundice
* pulmonary and renal chronic diseases,
* prostatic diseases
* autoimmune diseases
* diabetes mellitus
* decompensated cirrhosis
* pregnancy
* cardiopathy
* hemoglobinopathies
* hemocromatosis
* major depression
* severe psychiatric pathological conditions

Primary outcomes:
measure: Work Productivity and Activity Impairment in workers with chronic hepatitis C
timeFrame: 12 months
Secondary outcomes:
measure: Fatigue in workers with chronic hepatitis C
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06928090: Efficacy and Safety of DTG/3TC in Treatment-naïve HIV-1 Infected Patients
Official title: A Retrospective Observational Study of Efficacy and Safety of DTG/3TC(Dolutegravir/Lamivudine) in Treatment-naïve HIV-1 Infected Patients From at Real-life Cohort in Korea
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: HIV
Lead sponsor: Chungnam National University Hospital
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Estimated enrollment: 150-200 subjects.

Brief summary: Non-interventional, retrospective, single arm study of individuals who have initiated a DTG/3TC regimen. Medical chart will be reviewed by the investigators. Naive subjects will be identified by the clinic database as having initiated DTG/3TC.


Eligibility criteria: Inclusion Criteria:

* HIV-1 diagnosis
* Prescribed DTG/3TC alone to manage HIV-1 infection as initial antiretroviral treatment at the study centers

Exclusion Criteria:

* HIV-2 diagnosis
* Previous antiretroviral treatment

Primary outcomes:
measure: Percentage of patients achieving viral suppression
timeFrame: At week 48 after DTG/3TC treatment
Secondary outcomes:
measure: Change in CD4+cell counts
timeFrame: From baseline to week 48
measure: Persistence on DTG/3TC
timeFrame: At 48 weeks
measure: Reasons for Discontinuation
timeFrame: Up to 48 weeks.
measure: Changes in BMI
timeFrame: From baseline to week 48
measure: Changes of lipid profile
timeFrame: From baseline to week 48
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital, 282 Munwha-ro
Study officials:
affiliation: Chungnam National University Hospital
name: Yeon-sook kim
role: STUDY_DIRECTOR
References:
Clinical trial NCT01939990: Safety Study of Nebivolol for COPD Patients
Official title: Nebivolol in Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: High Blood Pressure
Keywords: Chronic Obstructive Pulmonary Disease
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2013-09-11
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to demonstrate the safety and effectiveness of the study drug Nebivolol, in people who suffer with high blood pressure with Chronic Obstructive Pulmonary Disease (COPD).

Detailed description: The study would be a randomized, placebo-controlled trial of 60 hypertensive patients with documented COPD greater than age 40.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of high blood pressure and chronic obstructive pulmonary disease (COPD)

Exclusion Criteria:

* Asthma; Heart failur;
* End stage kidney disease;
* acute myocardial infarction,unstable angina, stroke or TIA within the past year;
* Females who are pregnant, lactating or women of childbearing potential who are not using approved method of contraception.

Primary outcomes:
measure: to assess blood pressure control
timeFrame: baseline to 4 weeks
Secondary outcomes:
measure: to assess pulmonary function tests
timeFrame: baseline to 4 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: George Bakris, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04485390: Impact of the Organization of the First Responders in the Remote Areas on Cardiac Arrest Victim Survival
Official title: Impact of the Organization of the First Responders in the Remote Areas on Cardiac Arrest Victim Survival: an Utstein Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest, Sudden
Keywords: cardiac arrest
cardiopulmonary resuscitation
automated external defibrillator
first responders
Lead sponsor: University Medical Centre Maribor
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In the study will be included all adult cardiac arrest victims in the remote areas.

Brief summary: Emergency medical services (EMS) provide emergency care not only in the urban but also in the remote areas which could be up to 40 minutes from the EMS station. Thus, a cardiac arrest victim in those remote areas has a low likelihood to survive the cardiopulmonary resuscitation. Therefore, we have organized first responders (who are mostly volunteer fire-fighters) in the remote areas and taught them how to perform basic life support (BLS) with use of an automated external defibrillator (AED). In the case of a cardiac arrest the medical dispatcher activates simultaneously the EMS and the first responders, who perform the BLS with the use of an AED before the arrival of EMS.

The aim of the study is to analyze and compare the survival of the cardiac arrest victims in remote areas in the time period when the first responders were not organized yet compared to the time period when the first responders were activated to perform BLS.


Eligibility criteria: Inclusion Criteria:

* cardiac arrest in adult victims

Exclusion Criteria:

* cardiac arrest in pediatric population

Primary outcomes:
measure: Return of spontaneous circulation (ROSC)
timeFrame: 5 years
measure: Survival to hospital discharge
timeFrame: 5 years
measure: Neurological outcome
timeFrame: 5 years
Secondary outcomes:
measure: Survival till hospital admission
timeFrame: 5 years
measure: 30 day survival
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02853890: Management of Obstetrical Pain: " 7 Days Survey of Obstetric Analgesia/Anesthesia in France"
Official title: " 7 Days Survey of Obstetric Analgesia/Anesthesia in France" (EPIDOL)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Birth
Keywords: Birth
obstetric analgesia
obstetric anesthesia
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-08-03
Enrollment: 2500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All woman patients hospitalized for delivery

Brief summary: Obstetric analgesia is a requirement of our times. The different applicable methods vary in effectiveness. The essential part is represented by epidural analgesia which remains one of the most effective methods. It is important to know other methods to respond to all requests. The applications of these methods, patient satisfaction and psychic experience, complications or incidents remain poorly or partially evaluated in France.

The main objective is to describe the different techniques of anesthesia/analgesia actually used in France for the management of pain during vaginal deliveries and cesarean sections on a representative sample of all maternity hospitals at a given time(7 days per maternity hospital, 63 maternity hospitals (levels I,II,III), so about 2500 births).

Secondary objectives will be multiple :

* Describe the results of analgesic methods on the physical pain of patients during labor by a global visual analog scale
* Describe the feeling of pregnant women relative to the different anesthesic and analgesic techniques, by an analysis of the questionnaire responses
* Describe the frequency of adverse events of birth


Eligibility criteria: Inclusion Criteria:

* All patients hospitalized in a maternity hospital for delivery during the 7 days defined for the study will be included

Exclusion Criteria:

* Patients under 18 years old
* Lack of understanding of the French language

Primary outcomes:
measure: Type of analgesia techniques
timeFrame: Day 0
measure: Type of anesthesia techniques
timeFrame: Day 0
Secondary outcomes:
measure: physical pain assessed by using a visual analog scale.
timeFrame: Day 1
measure: Assessment of the feeling of pregnant women about the analgesic and anesthesic techniques by a questionnaire
timeFrame: Day 2
measure: Collect of adverse events
timeFrame: Day 2
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Femme Mère Enfant
Study officials:
affiliation: Hospices Civils de Lyon
name: Dominique Chassard, Pr
role: PRINCIPAL_INVESTIGATOR
References: