louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00674570: Veteran Stress and Learning Study
Official title: Effects of Hydrocortisone and D-Cycloserine on Fear Extinction in Veterans With Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stress Disorders, Posttraumatic
Keywords: Stress Disorders, Posttraumatic
Hydrocortisone
Cycloserine
Extinction, Psychological
PTSD
San Francisco
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2008-05-08
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a research study examining the use of two medications, Hydrocortisone and D-Cycloserine, compared to an inactive substance (placebo), on their ability to reduce fear responses and memory of fear in Veterans with symptoms of Posttraumatic Stress Disorder (PTSD). These responses will be tested using a fear learning and memory task administered by computer.


Eligibility criteria: Inclusion Criteria:

* Veterans and civilians with an age range of 18 to 65 years
* Participants must be physically healthy volunteers

Exclusion Criteria:

* Individuals who fall outside the age range
* Individuals with medical conditions that would interfere with participation
* Other criteria

Primary outcomes:
measure: Proportion of Maximum Skin Conductance Response (SCR) in Microsiemens (µS)
timeFrame: 15 minute measurement intervals on Study Days 7, 9, and 16
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center, San Francisco, CA
state: California
Study officials:
affiliation: San Francisco VA Medical Center, San Francisco, CA
name: Sabra S Inslicht, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alexandra Kredlow M, Pineles SL, Inslicht SS, Marin MF, Milad MR, Otto MW, Orr SP. Assessment of skin conductance in African American and Non-African American participants in studies of conditioned fear. Psychophysiology. 2017 Nov;54(11):1741-1754. doi: 10.1111/psyp.12909. Epub 2017 Jul 4.
citation: Inslicht SS, Metzler TJ, Garcia NM, Pineles SL, Milad MR, Orr SP, Marmar CR, Neylan TC. Sex differences in fear conditioning in posttraumatic stress disorder. J Psychiatr Res. 2013 Jan;47(1):64-71. doi: 10.1016/j.jpsychires.2012.08.027. Epub 2012 Oct 26.
citation: Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for universal prevention of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2022 Feb 10;2(2):CD013443. doi: 10.1002/14651858.CD013443.pub2.
Clinical trial NCT00861770: Utilizing Blood Volume Measurements in the Treatment of Heart Failure Patients
Official title: Prospective Protocol for Utilizing Blood Volume Measurements in the Treatment of Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure
Keywords: Congestive Heart Failure
Ultrafiltration
Blood Volume Measurement
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
Collaborators: name: Daxor Corporation
First posted: 2009-03-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This will be a clinical test to determine if using blood volume measurements (BVM) to help guide fluid removal with ultrafiltration in patients hospitalized with decompensated heart failure leads to improved outcomes.

Detailed description: Subjects will be randomized into two groups. In the control group, the treating physician will not see the blood volume measurement results. In the experimental group, the physician will be given the blood volume measurement results. Ultrafiltration is performed based on the results of blood volume measurement in the experimental group followed by repeat blood volume analysis after 30 minutes of the completion of ultrafiltration. Clinical and laboratory assessment as per the standard of care will be used to assess overall fluid status, and blood volume measurement results will be used as the assessment of intravascular fluid. These assessments will be used to determine a goal quantity of fluid to be removed. All subjects will return for a clinical assessment at 30 and 90 days and laboratory data will be drawn at that time to evaluate renal functional indices, electrolytes and blood volume measurements.

Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of heart failure
* \>/= 2 criteria of volume overload

  1. JVD \> 7 cm
  2. Ascites
  3. Lower extremity edema
  4. Sacral Edema
  5. Pleural effusion by clinical or radiologic criteria
* CKD 3 or worse renal function ClCR \< 60 ml/min
* HCT \< 40%
* Serum Albumin \>/= 2.5 gm/dL

Primary outcomes:
measure: To determine if using blood volume measurement to help guide fluid removal with ultrafiltration in patients hospitalized with decompensated heart failure leads to improved outcomes.
timeFrame: 90 days
measure: Change in serum creatinine ≥ 0.5 mg/dL.
timeFrame: 30 and 90 days
measure: Symptomatic hypotension during ultrafiltration.
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care Health Services
state: Delaware
Study officials:
affiliation: Christiana Care Health Services
name: Mitchell Saltzberg, MD, FACC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03442270: Detection Rate of Serrated Adenomas in Screening Colonoscopy
Official title: Detection Rate of Serrated Adenomas in the Screening Colonoscopy Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Patients Undergoing Screening Colonoscopy
Keywords: Serrated Adenoma, Colonoscopy
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
Collaborators: name: TriHealth Hatton Research Institute
First posted: 2018-02-22
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 50 years or older undergoing first-time colonoscopy screening

Brief summary: An observational prospective will be conducted to determine the detection rate of serrated adenoma during screening colonoscopy at our institution. Additionally, the variability of serrated adenoma detection among endoscopists will be evaluated and the characteristics of serrated adenomas will be described.

Detailed description: Colonoscopy screening is a preventative measure for colorectal carcinoma (CRC), a highly malignant and dangerous cancer. Extensive research on the adenoma detection rate has provided national standards and quality metrics to help assess competence of endoscopists. Currently, there are no standards established for serrated adenomas. The proposed study would be conducted at Good Samaritan Hospital (GSH) and TriHealth Surgery Center West. This is an observational study and does not involve any patient interventions. However, because patient healthcare data will be collected for research, informed consent will be obtained shortly before the procedure. The main study objective is to determine the detection rate of serrated adenoma during screening colonoscopy at our institution. Additionally, the variability of serrated adenoma detection among endoscopists will be evaluated and the characteristics of serrated adenomas will be described.

Eligibility criteria: Inclusion Criteria:

* Males and females

Exclusion Criteria:

* First degree relative (patient's parent, sibling or child) diagnosed with colorectal carcinoma at age of 59 or under
* New onset of iron deficiency anemia (within past 3 months)
* Abnormal imaging of colon within past 3 months
* Inadequate visualization reported by endoscopist
* Pregnant women

Primary outcomes:
measure: Serrated Adenoma
timeFrame: March 2018 to October 2018
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
Study officials:
References:
citation: Kim HY, Kim SM, Seo JH, Park EH, Kim N, Lee DH. Age-specific prevalence of serrated lesions and their subtypes by screening colonoscopy: a retrospective study. BMC Gastroenterol. 2014 Apr 28;14:82. doi: 10.1186/1471-230X-14-82.
Clinical trial NCT00400270: Breathing and Relaxation Exercises for Asthma: a Randomised Controlled Trial
Official title: A Physical Therapy Treatment for Adults Diagnosed With Asthma in Primary Care: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Randomised controlled trial
Breathing exercises
Relaxation exercises
Primary care
Lead sponsor: University College London Hospitals
Sponsor class: OTHER
Collaborators: name: Welwyn Hatfield Primary Care Trust
name: University College, London
First posted: 2006-11-16
Enrollment: 56
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: All patients on the GP asthma database in one practice were invited for an asthma physical-therapy assessment, at baseline. Volunteers satisfying the inclusion criteria ie - aged between 16 and 70, able to understand, read and write English, give informed consent, willing to attend the surgery to take part in the trial and with no other serious conditions - were invited to participate in the study. Patients were randomised either to a control group, receiving 2 more assessments at 6 and 12 months, or for comparison to a group receiving 5 physical-therapy treatments of integrated breathing and relaxation exercises (known as the Papworth Method (PM)). The two groups would then be compared at 6 and 12 months.

Hypotheses:

1. The PM of breathing and relaxation training would improve the quality of life for adult patients with asthma in primary care, compared with patients only receiving usual medical care.
2. Anxiety and depression, and symptoms from dysfunctional breathing would reduce compared with the control group.
3. Respiratory function measurements would improve compared with the control group.


Eligibility criteria: Inclusion Criteria:

* doctor diagnosed asthma, volunteers from the practice asthma database
* 16-70 years of age
* able to understand, speak and write English
* willing to give informed consent
* willing and able to attend the surgery for assessments and treatments

Exclusion Criteria:

* serious co-morbid conditions

Primary outcomes:
measure: Health related Quality of Life as measured by the St George's Respiratory Questionnaire
Secondary outcomes:
measure: Anxiety and Depression as measured by the Hospital Anxiety and Depression Scale.
measure: Symptoms from dysfunctional breathing measured by the Nijmegen Questionnaire.
measure: Respiratory measurements as measured by spirometry and capnography.
Other outcomes:
Locations:
city: Welwyn
country: United Kingdom
facility: Bridge Cottage Surgery
state: Hertfordshire
Study officials:
affiliation: Department of Epidemiology and Public Health, University College London
name: Professor Robert West, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03278470: A Single Ascending Dose Clinical Trial to Find the Maximum Tolerable Dose of HL237 in Healthy Male Subject
Official title: A Dose Block-randomized, Double Blinded, Placebo Controlled, Dose-escalation Clinical Trial to Find the Maximum Tolerable Dose After Single Oral Dose of HL237 in Healthy Male Subject
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Lead sponsor: Hanlim Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-09-11
Enrollment: 57
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: HL237 is a new autoimmune therapeutic agent for rheumatoid arthritis, including the basic structure of biguanide in metformin, an existing diabetes drug.

The immune modulating activity of HL237 was demonstrated in animal model. HL237 is a STAT3 inhibitor and STAT3 is well known for an important regulator inhibiting Th17 cells and activating Treg cells.

Therefore, when STAT3 activity is inhibited, it is expected to be able to treat autoimmune diseases such as rheumatoid arthritis.

This is the first clinical trial to be conducted for the development of HL237 and this clinical trial is for determining the maximum oral dose of HL237 and assessing safety, tolerability, and pharmacokinetic characteristics for each dose group.


Eligibility criteria: Inclusion Criteria:

* A healthy adult male aged 20 years or older and 45 years old at the time of the screening test
* Those who weigh more than 55kg but weigh less than ± 20% of ideal body weight
* Proper contraception during the clinical trial period
* After hearing the detailed explanation of the clinical trial, those who decide to participate voluntarily and write agreement

Exclusion Criteria:

* Clinically significant, a person with a history of neurological, psychiatric, malignant, cardiovascular, respiratory, kidney, endocrine, hematologic, digestive or central disease
* a person with a history of gastrointestinal disorders that may affect the absorption of pharmaceuticals for clinical trials (Crohn's disease, ulcers, etc.) or gastrointestinal surgery (except for simple cecal surgery or hernia surgery)
* a person with a history of hypersensitivity or clinically significant hypersensitivity to the clinical trial drug or additives
* a person judged to be inappropriate for the subject by health screening (history of disease, physical examination, vital signs, electrocardiogram, laboratory test, etc.)

Primary outcomes:
measure: Maximum Plasma Concentration [Cmax]
timeFrame: 3days after administration
measure: Area Under the Curve [AUC]
timeFrame: 3days after administration
measure: half life [t1/2]
timeFrame: 3days after administration
Secondary outcomes:
measure: Number of participants with treatment-related adverse events
timeFrame: 14days after administration
Other outcomes:
Locations:
city: Soeul
country: Korea, Republic of
facility: The catholic university of korea seoul ST. mary's hospital
Study officials:
References:
Clinical trial NCT03089970: Using Breath Metabolites to Determine Specific Virus Infection in Asthmatic Patients
Official title: Using Breath Metabolites to Determine Specific Virus Infection in Asthmatic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Upper Respiratory Tract Infections, Asthma, Exhaled Breath
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2017-03-24
Enrollment: 19
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with asthma with or without an acute exacerbation will be recruited

Brief summary: Respiratory virus infections cause a majority of asthma exacerbations in the fall to spring months. Current diagnostic platforms for respiratory viruses have limitations including cost, availability, and invasiveness. The use of noninvasive breath collection to analyze breath metabolites may be used to differentiate virus-infected asthmatics from other causes of acute asthma exacerbations.


Eligibility criteria: Inclusion Criteria:

* Asthma, Age ≥12, Symptoms/signs of an early asthma exacerbation, Ability to provide exhaled breath condensate (EBC) x15 min, Body mass index (BMI) ≥18

Exclusion Criteria:

* Chronic lung diseases other than asthma (e.g., chronic obstructive pulmonary disease \[COPD\], lung cancer, fibrotic lung disease, etc.), Smoking in the past 7 days, Eating or non-clear liquids \<4 hrs prior to EBC collection, Pregnancy

Primary outcomes:
measure: Breath metabolite differences between groups
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis Medical Ceneter
state: California
Study officials:
affiliation: University of California, Davis
name: Michael Schivo, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00725270: Treatment of Schizoaffective Disorder Using Mifepristone
Official title: Treatment of Schizoaffective Disorder Using Mifepristone
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Psychotic Disorders
Depressive Disorder, Major
Depressive Disorder
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Pritzker Family Foundation
First posted: 2008-07-30
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study tests the hypothesis that mifepristone will diminish cognitive distortion and alleviate psychosis in patients with schizoaffective disorder.

Detailed description: You are invited to participate in a research study which evaluates the effectiveness of mifepristone (RU 486) in rapidly reducing the symptoms associated with schizoaffective disorder. Our group believes that the cognitive deficits (a decline in the ability to think clearly) and psychosis (hallucinations or delusions) exhibited in some affective disorders are driven by an excess of stress hormone effects (hypercortisolemia). Often the origin of this hormonal imbalance is unknown. Current treatment for schizoaffective disorder (characterized by mood swings and hallucinations and/or delusions) involves using a combination of antidepressant medication (for mood elevation), mood stabilizing medications (to prevent extreme high and low moods) and antipsychotic medication (for the correction of altered thinking). While these therapies are often effective, they can take several weeks or longer to work. We hope to uncover a quick, effective, safe therapy for the treatment of individuals with your condition.

Eligibility criteria: Inclusion Criteria:The subjects will be 30 inpatients or outpatients with schizoaffective disorder. Exclusion Criteria:Subjects must be between the ages of eighteen and seventy-five without major medical problems.

Primary outcomes:
measure: Change in Positive Psychotic Symptoms Over the Course of Treatment
timeFrame: 8 days
measure: Change in Mood Symptoms
timeFrame: Baseline and Day 9
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Jennifer Keller
role: STUDY_DIRECTOR
References:
citation: Cherian K, Schatzberg AF, Keller J. HPA axis in psychotic major depression and schizophrenia spectrum disorders: Cortisol, clinical symptomatology, and cognition. Schizophr Res. 2019 Nov;213:72-79. doi: 10.1016/j.schres.2019.07.003. Epub 2019 Jul 12.
Clinical trial NCT00873470: Wolff-Parkinson-White Syndrome Anterograde Refractory Period of Accessory Duct
Official title: Long Term Evolution of the Anterograde Refractory Period of Accessory Duct in the Wolff-Parkinson-White Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Wolff-Parkinson-White Syndrome
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2009-04-01
Enrollment: 13
Sex: ALL
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The study consists of the realization of a new esophageal stimulation for patients already stimulated 10 years ago.

The investigators would like to make a long term evaluation of the evolution of anterograde effective refractory period of accessory duct in the WPW syndrome.

This study will be realized by esophageal stimulation.


Eligibility criteria: Inclusion Criteria:

* 21 \< age \< 64 years
* First esophagal stimulation with evaluation of effective anterograde refractory period \> 10 years
* Informed consent signed
* Diagnosis of Wolff-Parkinson-White syndrome
* No procedure of ablation of accessory duct

Exclusion Criteria:

* Ablation of accessory duct
* Patient with contraindication to esophageal stimulation
* Patient with contraindication to effort test

Primary outcomes:
measure: Measurement of effective anterograde refractory period of accessory duct and its evolution for a follow up superior to 10 years
timeFrame: Day 0
Secondary outcomes:
measure: Triggering a supra-ventricular tachycardia during the stimulation.
timeFrame: Day 0
measure: Presence of symptoms linked to WPW syndrome during the interval separating the 2 esophageal stimulation.
timeFrame: Day 0
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes UH
Study officials:
References: