louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00699790: Proof of Confidence Study of CCR2 Antagonist (BMS-741672) in Insulin Resistance
Official title: A 12-Week Randomized, Double-Blinded Study to Evaluate the Effects of Daily Oral Doses of BMS-741672 in Drug-Naive Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Keywords: Diabetes
NOS
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2008-06-18
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether a CCR2 antagonist (BMS-741672) improves glucose homeostasis in drug-naive type 2 diabetic patients


Eligibility criteria: Inclusion Criteria:

* Drug-naive Type 2 diabetics with a screening HbA1c of ≥ 7.5% and ≤ 10%
* Screening FPG ≥ 140 mg/dL and ≤ 220 mg/dL
* BMI ≤ 40 kg/m2

Exclusion Criteria:

* Active tuberculosis
* Symptoms of poorly controlled diabetes
* History of diabetic ketoacidosis
* Significant cardiovascular history or gastrointestinal disorders
* History of unstable or rapidly progressing renal disease
* Active liver disease and/or significant abnormal liver function
* Abnormal chest x-ray at screening indicative of tuberculosis or other infection

Primary outcomes:
measure: Change in HbA1c
timeFrame: after 12 weeks of treatment
Secondary outcomes:
measure: Other glycemic, atherosclerosis, lipid and mechanism-based biomarkers will be measured
timeFrame: throughout the 12 weeks of treatment
Other outcomes:
Locations:
city: Dzerzhnsky
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Nizhny Novgorod
country: Russian Federation
facility: Local Institution
city: Saint Petersburg
country: Russian Federation
facility: Local Institution
city: Saint Petersburg
country: Russian Federation
facility: Local Institution
city: Saint-Petersburg
country: Russian Federation
facility: Local Institution
city: Saint-Petersburg
country: Russian Federation
facility: Local Institution
city: Tyumen
country: Russian Federation
facility: Local Institution
city: Voronezh
country: Russian Federation
facility: Local Institution
city: Yaroslavl
country: Russian Federation
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT01033903: Optimal Treatment of Miscarriage
Official title: Which is the Optimal Treatment for Miscarriage With a Gestational ac in the Uterus and Which Factors Can Predict if the Treatment Will be Successful?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abortion, Spontaneous
Keywords: Abortion, Spontaneous
Randomized Controlled Trial
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2009-12-17
Enrollment: 190
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of the study is to determine if there is a difference in the number of women with a complete miscarriage after 10 days between expectant management versus treatment with 800 micrograms of misoprostol intravaginally in women with an an incomplete miscarriage before 14 weeks and a gestational sac retained in the uterus.


Eligibility criteria: Inclusion Criteria:

* nonviable intrauterine pregnancy with retained gestational sac in the uterus
* the embryo if visible 5 to 35 mm without a heart beat
* vaginal bleeding
* circulatory stable
* hemoglobin at least 80 g/L

Exclusion Criteria:

* contraindications against misoprostol

Primary outcomes:
measure: complete miscarriage
timeFrame: 10 days
Secondary outcomes:
measure: complete miscarriage
timeFrame: 17 days, 24 days, 31 days
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Region Skane, Kvinnokliniken, University Hopsital MAS
Study officials:
References:
citation: Fernlund A, Jokubkiene L, Sladkevicius P, Valentin L. Misoprostol treatment vs expectant management in women with early non-viable pregnancy and vaginal bleeding: a pragmatic randomized controlled trial. Ultrasound Obstet Gynecol. 2018 Jan;51(1):24-32. doi: 10.1002/uog.18940. Epub 2017 Dec 5.
Clinical trial NCT04342403: Patient Reported Outcome Instruments in Sarcoidosis
Official title: Clinical Studies Network Research Trial: Development of an On-Line Sarcoidosis Assessment Platform (OSAP) to Validate Sarcoidosis Phenotypes and Monitor Disease Burden Longitudinally
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sarcoidosis
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Foundation for Sarcoidosis Research
name: Albany Medical College
First posted: 2020-04-13
Enrollment: 350
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: Patients followed at sarcoidosis clinics across United States

Brief summary: Evaluate change of quality of life of sarcoiodosis patients over a six months using various quality of life instruments including a monthly smart phone app.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of sarcoidosis by established criteria.
* Patient has completed pulmonary function tests (spirometry) as per standard of care at the enrollment visit.
* Ability to understand and read English at least at a 7th grade level.
* Have access to a computer, iPad, smart phone, or another electronic device that will support the on-line sarcoidosis assessment platform.
* The subject is willing to wear a daily activity and sleep tracker wristband (Fitbit ™ wristband) for 6 months.

Exclusion Criteria:

• Life expectancy of \< 1 year.

Primary outcomes:
measure: KSQ
timeFrame: 6 months
Secondary outcomes:
measure: SAT
timeFrame: 6 Months
measure: Visual Analog Scale (VAS)
timeFrame: 6 Months
measure: Forced Vital Capacity (FVC)
timeFrame: 6 months
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
References:
citation: Judson MA, Yucel R, Preston S, Chen ES, Culver DA, Hamzeh N, Lower EE, Sweiss NJ, Valeyre D, Veltkamp M, Victorson DE, Beaumont JL, Singh N, Shivas T, Vancavage R, Baughman RP. The association of baseline sarcoidosis measurements with 6-month outcomes that are of interest to patients: Results from the On-line Sarcoidosis Assessment Platform Study (OSAP). Respir Med. 2022 May;196:106819. doi: 10.1016/j.rmed.2022.106819. Epub 2022 Mar 18.
Clinical trial NCT00594503: Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Traumatic Brain Injury
Official title: Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Residual Neurological, Cognitive, Emotional, Behavioral Effects From Traumatic Brain Injury
Keywords: traumatic brain injury
Lead sponsor: Louisiana State University Health Sciences Center in New Orleans
Sponsor class: OTHER
Collaborators: name: Harch Hyperbaric Research Foundation
First posted: 2008-01-15
Enrollment: 45
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hypothesis: That SPECT brain imaging tracks and is consistent with clinical improvements in patients receiving hyperbaric oxygen therapy (HBOT) for chronic traumatic brain injury.

Detailed description: The study is a retrospective chart review of patients with chronic neurological, emotional, social, and cognitive deficits from mild, moderate, or severe traumatic brain injury who underwent SPECT brain imaging as part of their evaluation and treatment with hyperbaric oxygen therapy in my practice over the last two decades. The purpose of the study is to see if the functional imaging is consistent with the clinical and cognitive testing.

Eligibility criteria: Inclusion Criteria:

* Adults or children with traumatic brain injury at least one year old

Exclusion Criteria:

* None

Primary outcomes:
measure: SPECT brain imaging
timeFrame: After completion of HBOT
Secondary outcomes:
measure: Clinical history and physical exam
timeFrame: After completion of HBOT
measure: Cognitive testing
timeFrame: After the final HBOT
Other outcomes:
Locations:
city: Marrero
country: United States
facility: Family Physicians Center
state: Louisiana
Study officials:
affiliation: LSU School of Medicine, New Orleans
name: Paul G Harch, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01143103: Comparison Between Respiratory Therapy With Cough Assist Technique and Usual Respiratory Therapy in Intensive Care Patients Suffering of Neurologic Disorder
Official title: Comparison Between Respiratory Physiotherapy With Cough Assist Technique and Usual Respiratory Care in Intensive Care Patients Suffering of Neurologic Disorder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Neurologic Disorder
Keywords: Respiratory therapy in neurologic disorder
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2010-06-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The present study aims to compare the efficiency of respiratory therapy with cough assist and the efficiency of usual respiratory therapy in intensive care patients suffering of neurologic disorder and cough ineffectiveness. The investigators hypothesis is that cough assist is more efficient than usual respiratory care in this group of patients.


Eligibility criteria: Inclusion Criteria:

* Peak flow \< 270 ml if the patient has one of the following diagnostic: post neurosurgery status, cerebral trauma, tetraparesia or tetraplegia

Exclusion Criteria:

* Death expected in the following 24h
* Bulbar dysfunction if extubated
* pneumothorax
* intracerebral mass effect
* elevated intracranial pressure

Primary outcomes:
measure: Duration of stay in intensive care unit
measure: Number of additional unplanned respiratory therapy treatment
Secondary outcomes:
measure: Duration of stay in the hospital
measure: Pulmonary infection
measure: Oxygenation parameters before and after respiratory therapy
measure: Intracranial pressure elevation during respiratory therapy if an intracerebral pressure monitoring is available
measure: Need of reintubation in the 48h following successful intubation
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University hospital of Geneva
Study officials:
affiliation: University Hospital, Geneva
name: Didier Tassaux
role: STUDY_DIRECTOR
affiliation: University Hospital, Geneva
name: Lise Piquilloud
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00567203: A Study Of Adjunctive Treatment Of Cognitive Deficits In Schizophrenia
Official title: A Phase 1B Inpatient, Randomized, Double-Blind, Placebo-Controlled, Crossover Study Of The Safety And Efficacy Of Two Fixed Doses Of PF-3463275 In Adjunctive Treatment Of Cognitive Deficits In Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-12-04
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the safety, tolerability, and efficacy of two dose regimens of PF-3463275 compared with placebo added to ongoing atypical antipsychotic therapy for cognitive deficits in subjects with chronic symptoms of schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of schizophrenia
* In stable treatment with risperidone, olanzapine, quetiapine, ziprasidone, aripiprazole, or paliperidone for at least 2 months
* Stable symptoms of schizophrenia for at least 3 months.

Exclusion Criteria:

* Subjects with a psychiatric disorder other than schizophrenia
* Substance dependence or abuse
* Women who have child bearing potential.

Primary outcomes:
measure: Change from baseline in the CNS Vital Signs Cognition Battery composite score
timeFrame: 6 days
measure: Safety Endpoints: tolerability, laboratory tests, vital signs, and ECG's.
timeFrame: 38 days
measure: Pharmacokinetics of PF-3463275
timeFrame: 6 days
Secondary outcomes:
measure: Positive and Negative Syndrome Scale (PANSS)
timeFrame: 6 days
measure: Change from baseline in the CNS Vital Signs Cognition Battery domain scores
timeFrame: 6 days
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Pfizer Investigational Site
state: California
city: Willingboro
country: United States
facility: Pfizer Investigational Site
state: New Jersey
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02179203: Changes in Doppler Signals From the Lung Due to Cardiac Resynchronization in Heart Failure Patients
Official title: Lung Doppler Signals Changes in Response to Cardiac Resynchronization in Heart Failure Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Change in LDS Signals Due to Cardiac Synchronization Therapy
Lead sponsor: Echosense Ltd.
Sponsor class: INDUSTRY
First posted: 2014-07-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with indication for cardiac snchronization therapy

Brief summary: Study Purpose and Rationale The purpose of this study is to evaluate the lung Doppler signals changes during cardiac resynchronization procedure. As the LDS represent the various mechanical events of cardiac origin it is assumed that they may reflect the relative timing between contraction of the ventricles and atria and thus serve for effective synchronization of these activities.

Aim of the study:

The aim of the study is to assess whether the changes in Lung Doppler Signal (LDS) waves' characteristics will mimic the changes in echocardiographic parameters designed to assess diastolic inflow and systolic flow in patients undergoing Echo-based CRT optimization.


Eligibility criteria: Inclusion Criteria:

* Male and female patients 18 years or older, who met the indications for cardiac synchronization therapy (CRT) per the ACCF/AHA guidelines, underwent successful system implant for more than 3 months, and were referred to the CRT non-responder clinic at the Ohio State University for CRT- Echo optimization due to absence of clinical improvement in functional class or ejection fraction after the implant per the judgment of the referring physician.

Exclusion Criteria:

1. Chronic atrial fibrillation or new cardiac arrhythmias detected at the time of the visit that are known to affect the response to CRT (Atrial fibrillation, supraventricular tachycardia, ventricular tachycardia, or frequent premature ventricular contractions).
2. CRT device malfunction
3. Inadequate CRT programming that has contributed to lack of response to CRT
4. Coronary sinus lead anatomical or electrical malfunctions at the time of the visit
5. Acute systemic illness that can explain their lack of functional improvement (i.e., anemia, severe electrolyte imbalance, pneumothorax, pericardial effusion, pneumonia)
6. Inability to sign informed consent

Primary outcomes:
measure: Change in Doppler signals before and after CRT
timeFrame: During procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University 473 West 12th Ave.
state: Ohio
Study officials:
affiliation: Ohio State University
name: Hyesha Hasan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05760703: Evaluate the Safety and Efficacy of STSG-0002 Injection in Patients With Chronic Hepatitis B
Official title: Phase Ib/II: Multicenter, Open, Dose-escalation Evaluation of the Safety and Efficacy of STSG-0002 Injection in Patients With Chronic Hepatitis B Treated With Oral Antiviral Therapy(Long-term Follow-up)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Hepatitis b
Lead sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Beijing Sanuo Jiayi Biotechnology Co. LTD
First posted: 2023-03-08
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This trial is a multi-center, open, single-dose, dose-increasing trial，to evaluate the safety and efficacy of STSG-0002 injection in patients with chronic hepatitis B treated with oral antiviral therapy(Long-term follow-up).


Eligibility criteria: Inclusion Criteria:

* Patients with chronic HBV；
* Receiving anti-HB viral therapy；
* 10 IU/ml≤HBsAg≤3000 IU/ml.

Exclusion Criteria:

* Patients co-infected with hepatitis C virus, HIV, HAV, HDV, HEV;
* Liver cirrhosis;
* Hepatocellular carcinoma;
* Autoimmune liver disease;
* Clinical hepatic decompensation;
* Fibroscan\>12 kPa;
* a. hemoglobin\<110g/L（female）\<120 g/L（male），platelet\<ULN，white blood cell\<2.5×109/L；b. bilirubin\>1.5 ×ULN，ALT\>2 × ULN，serum albumin\<35 g/L；c. INR\>1.5；d. serum creatinine \>1.5×ULN.

Primary outcomes:
measure: Number of subjects of adverse events
timeFrame: Baseline to Day 180
measure: Number of subjects With Significant Abnormal Physical Examination
timeFrame: Baseline to Day 180
measure: Number of subjects of Significant Abnormal Vital Signs Findings
timeFrame: Baseline to Day 180
measure: Number of Participants With Significant Abnormal Laboratory Values
timeFrame: Baseline to Day 180
measure: Number of subjects With Significant Abnormal Electrocardiography (ECG) Findings
timeFrame: Baseline to Day 180
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Youan Hospital,Capital Medical
state: Beijing
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical
state: Chongqing
Study officials:
affiliation: Peking University First Hospital
name: Guiqiang Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05625503: Dilution of Verapamil During Intraarterial Administration
Official title: Does Dilution of Verapamil With Normal Saline or Blood Reduce Discomfort Felt During Intraarterial Administration?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Vasospasm;Peripheral
Burning
Pain
Keywords: cardiac catheterization
intra-arterial calcium channel blockers
radial artery spasm
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2022-11-23
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will be a randomized, single-blind, prospective trial designed to evaluate the efficacy and safety of intra-arterial (IA) Verapamil diluted with normal saline compared to undiluted IA Nicardipine during transradial access (TRA) for percutaneous coronary angiography. Patients who are 18 years or older and undergoing non-emergent percutaneous coronary angiography via TRA will be included. Patients who are non-English speaking, pregnant, or intubated will be excluded. Patients will be randomized to one of the two following groups:

1. Group 1 will receive IA Verapamil 5 mg (2mL) diluted with 8 mL of normal saline
2. Group 2 will receive IA Nicardipine 400 mcg (undiluted, 8 mL)

The investigators will document the patient's level of discomfort on the Visual Analogue Scale 30 seconds before and after administration of IA Verapamil/Nicardipine. The investigators will also document the presence of radial artery spasms.


Eligibility criteria: Inclusion Criteria

* English Speaking patients who are age 18 or older
* Patient must be able to provide own consent and communicate with staff
* Patient's undergoing transradial access (TRA) for the left heart catheterization (LHC)

Exclusion Criteria

* Intubated or sedated patients
* Agitated patients requiring moderate sedation prior to TRA
* Patient's undergoing femoral access for the LHC
* Non-English speaking patients
* Contraindications to Verapamil or Nicardipine: including allergies to these medications, hypotension (mean arterial pressure \<65), Bradycardia (heart rate\<40)
* Emergent cardiac catheterization
* Inability to obtain radial artery access
* Conversion to radial artery access from another access site

Primary outcomes:
measure: Radial Artery Spasm
timeFrame: approximately 30 minutes
measure: Pain Prior to Intra-arterial Calcium Channel Blocker Administration
timeFrame: 30 seconds prior to administration
measure: Pain After Intra-arterial Calcium Channel Blocker Administration
timeFrame: 30 seconds post administration
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois Hospital
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Khalil Ibrahim, MD
role: PRINCIPAL_INVESTIGATOR
References: