louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00259103: Recombinant Human Relaxin (rhRlx) in Pregnant Women Scheduled for Induction of Labor
Official title: A Phase II Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Safety, Pharmacokinetics and Efficacy of Intravenous Recombinant Human Relaxin (rhRlx) in Pregnant Women Scheduled for Induction of Labour
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Labor, Induced
Keywords: relaxin
pregnancy
cervical ripening
normal pregnancy at least at 40 weeks of gestation
Lead sponsor: Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
Sponsor class: INDUSTRY
First posted: 2005-11-29
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of rhRlx for cervical ripening, when compared to a placebo.

Detailed description: A multicenter, randomized, double-blind, placebo-controlled, dose escalation study of healthy female subjects at ≥ 40 weeks gestation and who are scheduled for induction. A dose-escalation portion of the study is followed by a randomized, double-blind, placebo-controlled portion of the study. The endpoints include cervical ripening, as well as progression to labor and delivery.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 40 years
* Normal pregnancy
* At least 40 weeks of gestation
* Otherwise healthy

Exclusion Criteria:

* Anemia or hypertension
* Presence of chronic disease
* Endometriosis
* Known fetal anomaly
* Substance abuse
* History of cancer

Primary outcomes:
measure: Cervical ripening
timeFrame: Through 24 hours
Secondary outcomes:
measure: Progression to active labor and delivery
timeFrame: Within 7 Days of Drug Infusion
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk State Medical Academy
city: Saint Petersburg
country: Russian Federation
facility: Evidence CPR
city: Saint Petersburg
country: Russian Federation
facility: D.O. Ott Research Institute of Obstetrics and Gynecology
Study officials:
affiliation: Chief Medical Officer of BAS Medical, Inc.
name: Sam Teichman, MD
role: STUDY_DIRECTOR
References:
citation: Weiss G, Teichman S, Stewart D, Nader D, Wood S, Breining P, Unemori E. Recombinant human relaxin versus placebo for cervical ripening: a double-blind randomised trial in pregnant women scheduled for induction of labour. BMC Pregnancy Childbirth. 2016 Sep 5;16(1):260. doi: 10.1186/s12884-016-1046-1.
Clinical trial NCT01509703: Respiratory Physiology Under High Flow Therapy
Official title: Respiratory Physiology Measurements Under Transnasal High Flow Therapy in Patients With Tracheostoma After Long Term Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Nasal High Flow Therapy
tracheotomy stent
tracheotomy
Lead sponsor: Institut für Pneumologie Hagen Ambrock eV
Sponsor class: INDUSTRY
First posted: 2012-01-13
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to gain knowledge about effects of high flow transnasal insufflation on various breathing parameters like intratracheal pressure conditions, CO2 elimination, breathing frequency and tidal volume.

Detailed description: Ten patients, who are supplied with a tracheostomy stent (placeholder) for reinsertions after long term ventilation will be treated for a short time during the day with the nasal high flow system AIRVO at different flow rates (15, 30, 45L/min) to estimate possible long term implications of high flow treatment.

Respiration is measured by impedance plethysmography with a calibrated belt system (Respitrace, VIASYS). Pressure and end tidal CO2 concentration is measured inside of the placeholder.

The order of the high flow rates (15, 30, 45L/min) is randomized; each flow rate is measured for 15 minutes. A wash out time of ten minutes is planned after each phase. In this time the patient breathes his individual oxygen flow rate with attention to the oxygen saturation, which should not exceed 96%. Transcutaneous PCO2 and SpO2 is monitored with TOSCA during the study.

Eligibility criteria: Inclusion Criteria:

* Patients in a stable weaning phase after long term ventilation
* Patients supplied with tracheostomy stent (placeholder)
* Patients in stable respiratory situation

Exclusion Criteria:

* Incapable of giving consent
* Any other severe or acute physical illness which requires intensive medical care

Primary outcomes:
measure: Intratracheal pressure conditions
timeFrame: 2 hours
Secondary outcomes:
measure: Intratracheal endtidal CO2 concentration
timeFrame: 2 hours
measure: Breathing frequency and tidal volume
timeFrame: 2 hours
Other outcomes:
Locations:
city: Hagen
country: Germany
facility: Helios Klinik Hagen Ambrock
state: NRW
Study officials:
affiliation: Helios Klinik Hagen Ambrock, Germany
name: Georg Nilius, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05526703: Clinical Trial to Evaluate the Efficacy and Safety of D064 and D701 Combination Therapy
Official title: A Randomized, Double-blind, Multi-center, Therapeutic Confirmatory, Phase 3 Trial To Evaluate the Efficacy and Safety of D064 and D701 Combination Therapy in Essential Hypertension Subjects Inadequately Controlled by D064 Monotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Essential Hypertension
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2022-09-02
Enrollment: 108
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical Trial to Evaluate the Efficacy and Safety of D064 and D701 Combination Therapy.


Eligibility criteria: Inclusion Criteria:

1. Subjects who are 19 years old or older.
2. Subjects who have voluntarily decided to participate in this clinical trial and signed ICF.

Exclusion Criteria:

1. Subjects with a history of secondary hypertension or suspected secondary hypertension
2. Subjects who require combination administration of antihypertensive drugs other than clinical trial drugs during the clinical trial participation period
3. Subjects with hypersensitivity or history of clinical trial drugs and similar drugs
4. Subjects who are required to administer a combination of prohibited drugs specified in this plan during the clinical trial participation period
5. Subjects with a history of drug or alcohol abuse or suspected patient within 24 weeks as of the time of screening
6. Subjects who received other clinical trial drugs within 4 weeks of screening visit.
7. Pregnant women, lactating women, or Subjects who do not agree to use appropriate contraception during the clinical trial period and for two weeks after the end of administration of the last clinical trial drug
8. Subjects who are unable to participate in this clinical trial at the discretion of the investigator.

Primary outcomes:
measure: Change from baseline in MSSBP
timeFrame: 8 weeks after drug administrations
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT03789903: Amniotic Fluid Lactate in Perterm Premature Rupture of Membranes
Official title: Amniotic Fluid Lactate in Predicting Latency in Perterm Premature Rupture of Membranes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rupture of Membranes; Premature
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-12-31
Enrollment: 80
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: AF lactate level could help in predicting the duration from ROM till delivery


Eligibility criteria: Inclusion Criteria:

1. women with PPROM
2. GA between 24 to 34 weeks

Exclusion Criteria:

1. chorioamnionitis
2. previous Preterm labor
3. abruptio placentae
4. UTI ,pyelonephritis

Primary outcomes:
measure: latency period
timeFrame: upto 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AinShams university maternity hospital
state: Abbassya
Study officials:
References:
Clinical trial NCT04489303: Virtual Patient Behavioral Response Training for Family Caregivers
Official title: Virtual Patient Behavioral Response Training for Family Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer Disease
Lead sponsor: Photozig, Inc.
Sponsor class: INDUSTRY
First posted: 2020-07-28
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Our study is designed to help caregivers of someone with Alzheimer's Disease and related dementia to understand and deal with the difficult behaviors of a person with dementia.

Detailed description: The goal of this study is to develop and evaluate the Caring Response mobile app, containing a training that builds skills and stimulates practice. The investigators are evaluating different materials, which may encourage caregiver participation, enable user interaction, and promote better assimilation of concepts. The research team is designing the program to help to enhance caregivers' skills to deal with difficult behaviors, reduce distress, and improve quality of life.

Eligibility criteria: Inclusion Criteria:

* Care for an individual with Alzheimer's Disease or other dementia.
* Own a smartphone or tablet and have Internet access.
* Minimum age of 18 years old.
* Spend at least 8 hours/week caring for a person with dementia.

Exclusion Criteria:

* Severe psychological or physical illness.
* Inability to read and follow English instructions.
* High level of depressive symptoms.
* Unwillingness to participate in all aspects of the study.

Primary outcomes:
measure: Revised Memory and Behavior Problems Checklist
timeFrame: 3 months
measure: Center for Epidemiological Studies Depression Scale
timeFrame: 3 months
measure: Perceived Stress Scale
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: Photozig, Inc.
state: California
Study officials:
affiliation: Photozig, Inc.
name: Bruno Kajiyama, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00629603: Polymorphisms of Fibrosis-Relating Genes on Outcome of HCV-Related Chronic Liver Disease
Official title: Polymorphisms of Fibrosis-Relating Genes on Outcome of HCV-Related Chronic Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibrosis
Chronic Liver Disease
Keywords: hepatitis C virus infection
chronic liver disease
fibrosis-related cytokine
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2008-03-06
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Hepatitis C virus (HCV) infection causes different disease spectrum ranging from minimal progressive liver disease to cirrhosis or hepatocellular carcinoma. Evidence indicates that host genetic factor may play a role in determining disease progression. It is known that many cytokine polymorphisms affect disease progressin via increasing hepatic fibrosis that are key factors in progressing liver injury. By combinations of fibrosis-relating gene polymorphisms, this study aims to identify patients with high risk for progressive liver disease. These patients need intensive therapy to decrease morbidity and mortality of chronic HCV-related liver disease.

Detailed description: Determination of the following fibrosis-relating gene polymorphisms in HCV-related chronic liver disease and HCC will be performed: TNF-α , TNF-β, Factor V Leiden, TGF-β1, PDGF-B gene, Angiotensinogen (AT),Angiotensin converting enzyme (ACE), microsomal epoxide hydrolase (mEH) and glutathione-S-transferase (GST).

Eligibility criteria: Inclusion Criteria:

* Patients with anti-HCV positive

Exclusion Criteria:

* Anti-HCV-negative patients

Primary outcomes:
measure: cytokine gene polymorphism on disease severity
timeFrame: years
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
affiliation: Professor of Medicine
name: Jung-Fa Tsai, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02895503: Yoga in Improving Quality of Life in Patients With Non-small Cell Lung Cancer Undergoing Treatment
Official title: The Effect of Yoga and Exercise on the Quality of Life of Patients With Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Non-small Cell Lung Cancer
Recurrent Non-Small Cell Lung Carcinoma
Keywords: Stage IA Non-Small Cell Lung Carcinoma
Stage IB Non-Small Cell Lung Carcinoma
Stage IIA Non-Small Cell Lung Carcinoma
Stage IIB Non-Small Cell Lung Carcinoma
Stage IIIA Non-Small Cell Lung Cancer
Stage IIIB Non-Small Cell Lung Cancer
Stage IV Non-Small Cell Lung Cancer
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research study is to evaluate the effects of yoga (including breathing exercises) on the quality of life in patients, diagnosed and undergoing standard treatments for non-small cell lung cancer.

Detailed description: This clinical trial studies yoga in improving quality of life in patients with non-small cell lung cancer undergoing treatment. Yoga may help improve quality of life and pulmonary functional capacity in patients with non-small cell lung cancer.

Eligibility criteria: Inclusion Criteria:

* Patients with any type of non-small cell lung cancer who are undergoing medical treatment, including surgery, radiation and / or chemotherapy.

Exclusion Criteria:

* Metastasis to the brain, problems during surgery leading to myocardial infarction or hemorrhage, cerebral infarction or hemorrhage, respiratory failure, non-healing surgical wound.

Primary outcomes:
measure: Change of the score of the Trial Outcome Index (TOI)
timeFrame: Baseline to up to 12 weeks
measure: Measures of pulmonary function
timeFrame: Baseline to up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University/Massey Cancer Center
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Mary S Shall, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05830903: Develop a Novel Occupational Training Program for Schizophrenia Patients Based on Virtual Reality Techniques
Official title: Develop a Novel Occupational Training Program for Schizophrenia Patients Based on Virtual Reality Techniques
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Cognitive Impairment
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Establish a novel vocational training program and test its validity in a pilot study.

Detailed description: 40 schizophrenia patients will be recruited to join the virtual reality based vocational training program, the training effect will be compared by interview skills and problem solving before and after the training.

Eligibility criteria: Inclusion Criteria:

* Having a diagnosis of schizophrenia based on the Diagnostic and Statistical Manual of Mental Disorders -5th version
* Aged between 20 and 55 years.
* Motivated to have a job.
* Having a full-scale IQ \> 70 on the Wechsler Adult Intelligence Scale-version IV.
* Having a PANSS positive scale \< 70, indicating a stable condition during the illness course.

Exclusion Criteria:

* Comorbid with other major psychiatric disorders (i.e., bipolar disorders) or neurological diseases.
* Substance abuse within one year.
* Visual impairment and/or hearing impairment that would preclude participation in the VR-based training program.

Primary outcomes:
measure: clinical ratings of schizophrenia symptoms
timeFrame: 8 weeks
measure: vocational skills
timeFrame: 8 weeks
measure: global improvement
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yi Ling Chien
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01410903: Immunoadsorption in Patients With Severe Systemic Sclerosis
Official title: Immunoadsorption in Addition to the Established Therapy in Patients With Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Systemic Scleroderma
Lead sponsor: GWT-TUD GmbH
Sponsor class: OTHER
Collaborators: name: Miltenyi Biomedicine GmbH
First posted: 2011-08-05
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate source data for the survival and the investigation of the preliminary efficacy of immunoadsorption in patients with severe systemic sclerosis.


Eligibility criteria: Inclusion Criteria:

* systemic sclerosis according to the ACE-criteria
* severe pulmonary manifestation with reduced DLCO
* signed informed consent

Exclusion Criteria:

* inadequate peripheral venous access
* participation in another clinical trial
* heart failure
* pronounced allergic diathesis, particularly in case of known hypersensitivity to drugs and/or materials used in the extracorporeal circuit

Primary outcomes:
measure: survival under immunoadsorption
timeFrame: 6 months
Secondary outcomes:
measure: survival under immunoadsorption
timeFrame: 12 months
measure: Number of Serious Adverse Events
timeFrame: 12 months
measure: change in "modified Rodnan Skin Score"
timeFrame: 12 months
measure: change in Diffusing Capacity of the Lung for Carbon Monoxide
timeFrame: 12 months
measure: change in Scleroderma Health Assenssment Questionnaire
timeFrame: 12 months
measure: change of pulmonary arterial pressure
timeFrame: 12 months
measure: reoccurrence of finger ulcers
timeFrame: 12 months
measure: healing of finger ulcers
timeFrame: 12 months
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Universitätsklinikum Dresden
Study officials:
affiliation: Universitätsklinikum Dresden
name: Martin Aringer, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00006503: Prevalence & Progression of Subclinical Atherosclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Cardiovascular Diseases
Coronary Arteriosclerosis
Carotid Artery Diseases
Menopause
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2000-11-17
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To evaluate subclinical atherosclerotic disease in menopausal women.

Detailed description: BACKGROUND:

Decreased ovarian function and premenopausal obesity are likely the primary determinants of early coronary atherosclerosis as measured by calcification on EBCT. Aortic calcification occurs earlier than coronary calcification, may predict coronary calcification, and is expected to be the best marker of risk associated with traditional factors in these younger women. Preliminary data indicate that changes in coronary and aortic calcification can be observed over short periods of time in these women. A period of diminishing estrogen levels is the optimum time to observe changes in endothelial function which likely precede measurable atherosclerosis and thus may be the earliest markers for disease potential. Vascular stiffness, a marker for the biologic aging of the vascular system, is highly correlated with measures of insulin sensitivity which is altered in women at mid-life in conjunction with increases in central adiposity. Racial differences in disease prevalence and the relative importance of certain risk factors are likely.

DESIGN NARRATIVE:

Subclinical atherosclerosis will be evaluated in 728 women (305 African American, 423 Caucasian) enrolled in the Pittsburgh and Chicago sites of the Study of Women's Health Across the Nation (SWAN), a multicenter study characterizing the biological and psychosocial antecedents and sequellae of menopause. The extent to which diminishing ovarian function affects vascular function and accelerates the development of atherosclerosis in the coronary arteries, aorta and carotid arteries will be evaluated. Serial measures of coronary and aortic calcification (by electron beam computed tomography \[EBCT\] ), carotid atherosclerosis, endothelial function and aortic stiffening will be performed two years apart. The prevalence and progression of subclinical atherosclerosis will be evaluated in relation to serial measures of ovarian function, psychosocial and behavioral factors, markers of clotting and inflammation as well as traditional cardiovascular risk factors, all collected in SWAN. The study is conducted jointly by Dr. Lynda Powell (R01HL65581) at Rush-Presbyterian-St. Luke's Medical Center in Chicago and Dr. Kim Tyrrell (R01HL65591) at the University of Pittsburgh.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rush-Presbyterian-St. Lukes Medical Center
name: Lynda Powell
affiliation: University of Pittsburgh
name: Kim Tyrrell
References: