louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00495196: Cardiovascular Responses in Congestive Heart Failure With Cheyne- Stokes Respiration
Official title: Cardiovascular Response to Peripheral Chemoreceptor Stimulation in Congestive Heart Failure With Cheyne- Stokes Respiration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure, Congestive
Cheyne-Stokes Respiration
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2007-07-02
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the trial is to investigate the cardiovascular response to peripheral chemoreceptor stimulation in Congestive Heart Failure with Cheyne- Stokes Respiration


Eligibility criteria: Inclusion Criteria:

* Moderate to severe heart failure (NYHA Class II or above) on optimal medical therapy
* LVEF less than or equal to 45%
* Stable condition as defined as no hospital admission or changes to medical therapy within two weeks prior to enrolment

Exclusion Criteria:

* Patients taking known respiratory stimulants or depressants
* Clinically significant asthma requiring therapy
* Significant parenchymal lung disease
* Primary pulmonary hypertension
* Myocardial infarction within three months prior to enrolment
* Patients with cardiac resynchronisation devices and permanent pacemakers
* Anaemic (haemoglobin \< 12g/dL)

Primary outcomes:
measure: Cardiovascular parameters such as continuous blood pressure and heart rate.
timeFrame: During administration of the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
Study officials:
affiliation: ResMed/The University of New South Wales
name: Rachel A Coxon, BE/MBiomedE
role: STUDY_DIRECTOR
affiliation: ResMed/The University of New South Wales
name: Klaus Schindhelm, PhD
role: STUDY_DIRECTOR
affiliation: Royal Prince Alfred Hospital, Sydney, Australia
name: Jodie Lattimore, PhD
role: STUDY_DIRECTOR
affiliation: Royal Prince Alfred Hospital/The University of Sydney
name: Ian Wilcox, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00036296: Effects of Talampanel on Patients With Advanced Parkinson's Disease
Official title: Effects of Talampanel on Patients With Advanced Parkinson's Disease Who Have Been on Sinemet for More Than 5 Years and Have Dyskinesia (Abnormal Involuntary Movements)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Dyskinesias
Parkinson Disease
Movement Disorders
Keywords: Involuntary Movements
Abnormal Movements
Advanced Parkinson's disease
Levodopa induced dyskinesia
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2002-05-09
Enrollment: 22
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to test the safety and effectiveness of the study drug, Talampanel, when used to treat patients with involuntary movements known as dyskinesias, as a result of treatment to Parkinson's disease.

It is not clear why people with Parkinson's disease develop involuntary movements (dyskinesias) but studies show that blocking receptors in the brain for a chemical called glutamate decreases these movements. Talampanel is a drug which blocks these receptors.


Eligibility criteria: Inclusion Criteria:

* Troublesome on-period dyskinesias as defined by a Unified Parkinson's Disease Rating Scale (UPDRS) dyskinesia sub-score \>25% of Duration of dyskinesia during waking hours and 33 must have moderate disability
* Lang-Fahn dyskinesia rating score more than 2 for at least two of the 5 tasks
* Must have Dyskinesia on average 25% of waking hours/day based on Patient Diaries
* Have been diagnosed with Parkinson's disease \> 5 years at Screening

Exclusion Criteria:

* Previous surgical therapies for PD
* Isolated or predominantly diphasic dyskinesias
* Moderate Dementia
* On disallowed concomitant medications including CYP3A4 inhibitors and inducers, amantadine, etc.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06144996: Development of a Canadian Bronchiectasis and NTM Database
Official title: Development of a Canadian Bronchiectasis and NTM Database
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bronchiectasis
Non-Tuberculous Mycobacterial Pneumonia
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Insmed Incorporated
name: Trudell Medical International
First posted: 2023-11-22
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients over the age of 18 with non-CF Bronchiectasis and/or Nontuberculosis Mycobacteria (NTM).

Brief summary: The investigators aim to develop a comprehensive patient registry of patients with non-CF bronchiectasis and/or Nontuberculosis Mycobacteria (NTM)

Detailed description: The investigators aim to develop a comprehensive patient registry of patients with non-CF bronchiectasis and/or Nontuberculosis Mycobacteria (NTM). This will entail inclusion of adults (age \>18 years) with a diagnosis of these conditions to be entered with complete clinical data and quality of life assessments entered into a patient registry.

Eligibility criteria: Inclusion Criteria:

* Over the age of 18
* Non-CF Bronchiectasis
* Nontuberculosis Mycobacteria (NTM)

Exclusion Criteria:

* Under the age of 18
* CF bronchiectasis

Primary outcomes:
measure: Patient Recruitment and Data analysis for NTM and Bronchiectasis
timeFrame: December 2050
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
References:
Clinical trial NCT02823496: 18349-Human Photoallergy Test
Official title: Human Photoallergy Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-07-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: To evaluate the potential of a test material to produce a photoallergic response.


Eligibility criteria: Inclusion Criteria:

* be male or female between the ages of 18 and 60 inclusive;
* be lightly pigmented (Fitzpatrick Skin Type I, II, III);
* have read and signed the written Informed Consent Form and have completed a Health Insurance Portability and Accountability Act (HIPAA) Authorization Form in conformance with 45CFR Parts 160 and 164;
* be in general good health as determined by the subject's medical history and in the discretion of the investigator;

Exclusion Criteria:

* have a visible sunburn;
* have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses;
* have a known hypersensitivity or allergy against any of the active and non-active ingredients of the investigational products.
* subjects who are employees of the CRO and/or Bayer or is a household member of an employee

Primary outcomes:
measure: Intensity of skin reactions is evaluated by 5 point scale
timeFrame: Up to 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Piscataway
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02378896: Personalized Computerized Inhibitory Control Training for OCD
Official title: Personalized Computerized Inhibitory Control Training for OCD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: Cognitive Behavioral Therapy
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2015-03-04
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effects of a computerized training program coupled with cognitive behavioral therapy (CBT) for OCD.

Detailed description: This study will evaluate the effectiveness of a computerized training program (called Personalized Computerized Inhibitory Training, or PCIT) coupled with cognitive behavioral therapies (CBT) consisting of Exposures and Response Prevention in treating obsessive compulsive disorder (OCD) in patients who previously underwent CBT, but still have residual symptoms.

Eligibility criteria: Inclusion Criteria:

* Principal diagnosis of OCD (assessed by SCID).
* Clinically significant OCD symptoms (Y-BOCS score of at least 16).
* Have a history of completing a trial of at least 1 EX/RP sessions.
* Have access to a computer or laptop.

Exclusion Criteria:

* Individuals with the following disorders will excluded: bipolar, psychosis, current major depressive disorder (assessed by SCID).
* Patients with head injury and loss of consciousness of more than five minutes or a neurological condition affecting the central nervous system.
* Patients taking a psychiatric medication will be asked to maintain a stable dose for 6 weeks prior to study entry.
* Vision or hearing loss (although individuals with vision corrected by glasses or contacts will not be excluded).
* Active suicidality warranting immediate clinical care.

Primary outcomes:
measure: Obsessive-compulsive symptoms measured after 3 weeks of treatment
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiactic Institute
state: New York
Study officials:
affiliation: New York State Psychiactic Institute, Anxiety Disorders Clinic
name: Helen B Simpson, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05975996: Cyclophosphamide Added to Standard Immunosuppressive Therapy With Herombopag as Front-line Therapy in Patients With Severe Aplastic Anemia
Official title: Cyclophosphamide Added to Standard Immunosuppressive Therapy With Herombopag as Front-line Therapy in Patients With Severe Aplastic Anemia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Severe Aplastic Anemia
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 43
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, single-center, single-arm, phase 2 study. This study aims to evaluate the efficacy and safety of Anti-lymphocyte globulin plus herombopag in combination with moderate-dose cyclophosphamide for severe aplastic anemia.


Eligibility criteria: Inclusion Criteria:

* Male or female age ≥ 12 years
* Subject has a diagnosis of naïve severe or very severe aplastic anemia
* ECOG performance status ≤2
* Unwilling or unable to receive allogeneic hematopoietic stem cell transplantation.
* Willing and able to comply with the requirements for this study and written informed consent.

Exclusion Criteria:

* Previously received immunosuppressive therapy \> 4 weeks
* Previously treated with TPO-RA \> 4 weeks
* Have an allergy or intolerance to either herombopag or cyclophosphamide.
* Have an allergy to ALG
* Uncontrolled systemic fungal, bacterial, or viral infection
* Poorly controlled hypertension (≥140/90mmHg) or diabetes (a fasting plasma glucose concentration ≥7.0mmol/L or a random venous plasma glucose concentration ≥11.1mmol/L)
* Abnormal liver or kidney function: ALT or AST \>3 ULN, or serum creatinine (sCr)≥ 2.5 ULN.
* History of radiotherapy and chemotherapy for malignant solid tumors
* Combined with other serious disorders
* Pregnant or breast-feeding patients
* Patients considered to be ineligible for the study by the investigator for reasons other than the above.

Primary outcomes:
measure: Overall response rate
timeFrame: Within 3 months
Secondary outcomes:
measure: Robust response
timeFrame: Within 3 months
measure: All-cause mortality
timeFrame: Within 3 months
measure: Time to achieve robust hematological response
timeFrame: Within 6 months
measure: Incidence of the adverse event
timeFrame: Within 6 months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Regenerative Medicine Center
state: Tianjin
Study officials:
affiliation: Institute of Hematology & Blood Diseases Hospital, China
name: Liwei Fang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03680196: The Effect of Botulinum Toxin Injection at Hip Adductor Muscles in Patients With Spastic Cerebral Palsy, Pilot Study
Official title: The Effect of Botulinum Toxin Injection at Hip Adductor Muscles in Patients With Spastic Cerebral Palsy, Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: hip dislocation
GMFCS level 3,4,5
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-09-21
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In children with cerebral palsy, secondary problems lead to hip dislocation. the purpose of this study is to find out the effects of botulinum toxin A on hip joint dislocation in cerebral palsy patients.

Detailed description: * Design: Prospective study
* Inclusion criteria of patient group: who has a cerebral palsy and GMFCS level 3,4,5
* Intervention: applied medication Botulinum A injection (meditox 200unit)
* Main outcome measures: The investigators will measure for finding evidence by checking the x-ray photograph, hip adductor and muscles pressure test and electromyography(EMG test) test of hip adductor, abductor and spine muscles.

Eligibility criteria: Inclusion Criteria:

* Severe cerebral palsy patients(GMFCS level 3,4,5)
* 2 to 10 years old

Exclusion Criteria:

* Those who disagree with the study.
* other than cerebral palsy.

Primary outcomes:
measure: Change from hip adductor and spin muscles electromyography(EMG) test at a month
timeFrame: once at study, when patient enrolled and every once a month for one year
Secondary outcomes:
measure: Whole spine AP and total Hip AP X-ray photograph
timeFrame: once at study, when patient enrolled and and after six month for one year
measure: hip adductor muscles pressure meter test
timeFrame: once at study, when patient enrolled and every once a month for one year
measure: Likert scale
timeFrame: once at study, when patient enrolled and every once a month for one year
measure: Hip and knee joint Range of motion(ROM) test
timeFrame: once at study, when patient enrolled and every once a month for one year
measure: CPCHILD sacle
timeFrame: once at study, when patient enrolled and every once a month for one year
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jusuk Ryu
role: STUDY_DIRECTOR
References:
Clinical trial NCT02524496: Limited Access Protocol for the Use of Oral Cisapride
Official title: Limited Access, Open-label, Compassionate Use of Cisapride in the Treatment of Gastroparesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroparesis
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2015-08-14
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects of the study were diagonosed with gastroparesis that was not being adequately treated.

Brief summary: Due to the lack of other drugs to treat gastroparesis Janssen and FDA approved the compassionate use of cisapride to treat patients who had no other effective therapy. For this observational study, 3 patients who had already been prescribed cisapride by outside physicians, were followed to determine the effectiveness of cisapride on their gastric emtpying.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of gastroparesis.

Exclusion Criteria:

* No diagnosis of gastroparesis.

Primary outcomes:
measure: Improvement in gastric emptying via self-report
timeFrame: ten years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00725296: Investigation of 9 Consecutive Infusions of Remicade for Psoriatic Arthritis in Austria (Study P04264)
Official title: Remicade Therapy in Psoriatic Arthritis: Investigation of Real Life Regimen in Austria Over 9 Consecutive Infusions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Psoriatic
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Centocor, Inc.
First posted: 2008-07-30
Enrollment: 178
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will receive Remicade induction therapy consisting of 3 infusions in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy will consist of a maximum of 6 infusions given in doses and intervals due to the discretion of physicians.

Brief summary: This is a prospective, open-label, 1-arm, multicenter observational study to determine the dose and time interval of Remicade (Infliximab) infusions in psoriatic arthritis (PsA).

Detailed description: This study population was chosen from a non-probability sample.

Eligibility criteria: Inclusion Criteria:

* Participants with active and progressive psoriatic arthritis who have responded inadequately to disease-modifying anti-rheumatic drugs.

Exclusion Criteria:

* All according to contraindications in the label especially:

  * Participants with tuberculosis or other severe infections such as sepsis, abscesses, and opportunistic infections.
  * Participants with moderate or severe heart failure (NYHA class III/IV).
  * Participants with a history of hypersensitivity to infliximab or to other murine proteins, or to any of the excipients.

Primary outcomes:
measure: Mean Time Interval Between Infusions During Maintenance Therapy
timeFrame: Up to 24 months
measure: Median Time Interval Between Infusions During Maintenance Therapy
timeFrame: Up to 24 months
measure: Average Dose During Induction Therapy and Subsequent Maintenance Therapy
timeFrame: Up to 24 Months
measure: Median Dose During Induction Therapy and Subsequent Maintenance Therapy
timeFrame: Up to 24 Months
measure: Average Overall Dose of All Infusions Per Participant
timeFrame: Up to 24 Months
measure: Median Dose of All Infusions Per Participant
timeFrame: Up to 24 Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01815996: Identify Clinical Conditions That Increase Circulating DNA Levels
Official title: Identify Clinical Conditions That Increase Circulating DNA Levels
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Pulmonary Embolism
Myocardial Infarction
Autoimmune Disease
Keywords: Pregnancy
pulmonary embolism
myocardial infarction
autoimmune disease
healthy controls
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2013-03-21
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Seeking healthy volunteers, pregnant women, patients who recently suffered a heart attach or pulmonary embolism, and patiebts with autoimmune disease. Patients who are health individuals will also be asked to participate.

Brief summary: The investigators are developing a test that is expected to measure the amount of radiation a patient has been exposed to after a nuclear bomb. The investigator will do this by measuring the DNA in the patients blood from cells killed by the radiation.

Many diseases and medical conditions can put DNA in the blood. The investigator needs to know how much DNA in order to better interpret our radiation detection test. Therefore, the investigator is collecting blood from several patients with different diseases or medical conditions and also healthy volunteers to measure their DNA content.

Patients that will be included in this study are pregnant women, patients who have suffered a pulmonary embolism within the past 48 hours, patients who have suffered from myocardial infarction in the past 48 hours, patients with autoimmune diseases and health patients.

Detailed description: The investigator will collect 8 mL (one and one half teaspoons) of blood one time only. The investigator may also collect the patient's past medical history, test results and disease treatment.

Eligibility criteria: Inclusion Criteria:

1. Patients must be adults in one of the following categories:

   * Pregnant
   * Suffered a pulmonary embolism within the past 48 hours
   * Myocardial infarction in the past 48 hours
   * Diagnosed with an autoimmune disease
   * Adults age 18-80
   * Self-declared healthy adults
2. Patients must be willing to undergo a blood draw
3. Patients must provide study-specific informed consent prior to study entry

Exclusion Criteria:

1. Patients not meeting the above inclusion criteria

Primary outcomes:
measure: Different diseases will be analysed for the levels of DNA circulating in the blood
timeFrame: blood will be tested up to 1 year after collection
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Shands Davis Cancer Center
state: Florida
Study officials:
affiliation: University of Florida
name: Paul Okunieff, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00220896: Prevention of Postoperative Delirium With Donepezil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cognitively Normal Elderly Individuals
Keywords: Delirium
Prevention
Donepezil
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Eisai Deutschland
First posted: 2005-09-22
Enrollment: 37
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients undergoing hip or knee joint replacement at the age of 70 years or above who are cognitively unimpaired will receive donepezil or matching placebo before (over 5-7 days), during and after (over 7 days) surgery. The incidence of delirium will be monitored at 3 days, 7 days, and 49 days following surgery. We hypothesize that the incidence of delirium can be lowered from 20 per cent to 10 per cent by the intervention.


Eligibility criteria: Inclusion Criteria:

* Cognitively healthy, elective hip or knee replacement

Exclusion Criteria:

* Ongoing cholinergic treatment, dementia, delirium, acute physical illness

Primary outcomes:
measure: Incidence of delirium
Secondary outcomes:
measure: Cognitive performance
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Deps. of Psychiatry and Anaesthesiology, Tech. Universitaet Munich
Study officials:
affiliation: Dept. of Psychiatry, Technische Universitaet Muenchen
name: Janine Diehl, M. D.
role: PRINCIPAL_INVESTIGATOR
References: