louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00950521: Efficacy Study of CD34 Stem Cell in Chronic Stroke Patients
Official title: Phase II Study of Autologous Peripheral Blood CD34 Stem Cell Implantation in Chronic Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stroke
Middle Cerebral Artery Infarction
Keywords: Stroke
Stem Cell
Cell Therapy
CD34 Stem cell
Peripheral blood Stem cell
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2009-07-31
Enrollment: 30
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to determine the efficacy of brain transplants of CD34+ stem cells obtained from peripheral blood of patients in the treatment of chronic stroke patients.

Detailed description: 30 patients are divided into 2 groups, one treatment group and one control group.Treatment group will be implanted with peripheral blood stem cell and receive convention stroke therapy ,and control group only receive convention stroke therapy. We expect that transplantation of the peripheral blood CD34+ cells has the potential of significant benefit to neurological recovery. In a previous phase I clinical trial, we have shown that transplantation of CD34+ cells obtained from the peripheral blood of the chronic stroke patients was safe and beneficial for neurological recovery. We expect this trial can further prove the efficacy of this treatment method.

Eligibility criteria: Inclusion Criteria:

* aged 35-70 chronic stroke adult patient,
* with stroke history of more than 6 months, less than 60 months，
* with stable hemiplegia condition, and
* NIHSS (NIH Stroke Scale) score is between 9-20.

Exclusion Criteria:

* patients aged less than 35 or more than 70,
* hemorrhage stroke or MRI show the occlusion is not in the middle cerebral artery territory，NIHSS is not in the range of 9-20,
* pregnant women,
* impaired liver function, abnormal blood coagulation, AIDS, combine other tumor or special condition.

Primary outcomes:
measure: NIH-stroke scale (NIHSS)
timeFrame: 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months
Secondary outcomes:
measure: European stroke scale (ESS)
timeFrame: 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months
measure: European stroke motor subscale (EMS)
timeFrame: 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months
measure: Barthel index and Mini-Mental State Examination (MMSE)
timeFrame: 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months
measure: Magnetic resonance imaging (MRI) and computed tomography (CT) scans
timeFrame: 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University Hospital
name: Shinn-Zong Lin, MD, DMSci
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mackie AR, Losordo DW. CD34-positive stem cells: in the treatment of heart and vascular disease in human beings. Tex Heart Inst J. 2011;38(5):474-85.
Clinical trial NCT00986921: Mifepristone Versus Laminaria Insertion for Cervical Preparation Prior to Surgical Abortion at 14-16 Weeks
Official title: Mifepristone vs. Laminaria Insertion for Cervical Preparation Prior to Surgical Abortion at 14-16 Weeks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abortion
Keywords: Length of time for procedure to be completed
Need for additional dilation
Subject satisfaction with procedure
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2009-09-30
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Women who are requesting pregnancy termination at 14-16 weeks, who would normally have osmotic dilator insertion the day before their procedure, would be asked if they wanted to participate. Participants would be randomized to two groups: first, dilator insertion as usual, or second, mifepristone taken the day before the procedure.


Eligibility criteria: Inclusion Criteria:

* women aged 18-45 having pregnancy termination at 14-16 weeks

Exclusion Criteria:

* multiple gestation, pre-existing infection, contraindication to osmotic dilators, unable to obtain proper consent

Primary outcomes:
measure: Time for Completion of Procedure
timeFrame: Performance and completion of the abortion procedure takes 10-20 minutes. The length of the procedure is measured. The procedure occurs approximately 24 hours after enrollment.
Secondary outcomes:
measure: Assessment of Ease of Procedure by Operator
timeFrame: It is administered shortly after the primary outcome, which is one day after enrollment. The study is complete at that point.
measure: Moderate or Severe Pain Overnight
timeFrame: Overnight
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston University
name: L B, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Borgatta L, Roncari D, Sonalkar S, Mark A, Hou MY, Finneseth M, Vragovic O. Mifepristone vs. osmotic dilator insertion for cervical preparation prior to surgical abortion at 14-16 weeks: a randomized trial. Contraception. 2012 Nov;86(5):567-71. doi: 10.1016/j.contraception.2012.05.002. Epub 2012 Jun 6.
Clinical trial NCT00680121: High Dose Vitamin B1 to Reduce Abusive Alcohol Use
Official title: The Effectiveness of Benfotiamine in Reducing Abusive Drinking Among Family History Positive and Negative Alcoholics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alcoholism
Keywords: Alcoholism
Benfotiamine
Thiamine
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2008-05-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: B1AS tests the hypothesis that increased vitamin B1 (thiamine) intake can repair brain systems damaged by alcohol and help people with alcohol problems control their alcohol use. A strong, man-made form of thiamine (Benfotiamine) is used to increase blood thiamine to much higher levels than can be achieved using normal vitamin supplements. Drinking patterns are examined over 6 months of continued supplement use. Men and women with a recent history of alcohol problems are eligible to participate.

Detailed description: B1AS is a randomized, double-blind placebo-controlled clinical trial of the effectiveness of Benfotiamine at reducing abusive drinking patterns in individuals with recent alcohol problems. Subjects consume 4 tablets of Benfotiamine (600 mg) or placebo daily for 6 months. Monthly follow-ups track alcohol use and alcohol-related problems over the 6 months. Blood tests are also conducted to determine the frequency of an inherited abnormality in thiamine processing that may be related to the risk of developing alcoholism.

Eligibility criteria: Inclusion Criteria:

* Problem drinking in the last 30 days

Exclusion Criteria:

* Prolonged abstinence
* Serious medical problems

Primary outcomes:
measure: Change in Average Daily Alcohol Consumption
timeFrame: Change from Baseline to 6 Months
Secondary outcomes:
measure: Alcoholism Severity Scale
timeFrame: 6 Months
measure: Barrett Impulsivity Scale: Total Impulsiveness
timeFrame: 6 Months
measure: Symptom Checklist-90 (SCL-90): Global Severity Index
timeFrame: 6 Months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Ann Manzardo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Manzardo AM, Pendleton T, Poje A, Penick EC, Butler MG. Change in psychiatric symptomatology after benfotiamine treatment in males is related to lifetime alcoholism severity. Drug Alcohol Depend. 2015 Jul 1;152:257-63. doi: 10.1016/j.drugalcdep.2015.03.032. Epub 2015 Apr 8.
Clinical trial NCT06968221: Bovine Reinforcement in Stomach, Colorectal and Lung Operation
Official title: A Study on the Safety and Efficacy of Using Cingular Bovine Pericardium Anastomosis Reinforcement Membrane for Tissue Reinforcement and Hemostasis at Anastomotic Sites
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Rectal Cancer Stage III
Lung Cancer Stage III
Lead sponsor: Shanghai Cingularbio Co. Ltd
Sponsor class: INDUSTRY
Collaborators: name: RenJi Hospital
First posted: 2025-05-13
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: with a bioabsorbable staple line reinforcement material compared with standard non-reinforced material
Primary purpose: TREATMENT

Brief summary: The primary purpose of this prospective, randomized multicenter center study is to evaluate and compare the outcomes of stomach,colorectal and lung anastomoses reinforced with a bioabsorbable staple line reinforcement material compared with standard non-reinforced techniques with respect to the incidence of postoperative hemorrage rate, anastomotic leakage, if applicable.

Detailed description: This is a randomized prospective trial that compares the use of Cingular Bioabsorbable Staple Line Reinforcement to standard stapling techniques in tissue resections. The potential exists to utilize staple line reinforcement as a means of lowering the rate of post-operative hemorrage rate, anastomotic leakage.

Eligibility criteria: Inclusion Criteria:

* Subjects who will undergo operation with stapled stomach, colorectal anastomosis with or without reinforcement
* Subjects willing to accept informed consent and willing to attend the follow up

Exclusion Criteria:

* Subjects who have significant intraoperative hypotension or cardiac events.
* Subjects with collagen vascular disease, coagulopathy, significant renal or hepatic dysfunction (creatinine \>1.6 or liver enzymes \> 50% upper limit of normal values).
* Subjects have uncontrolled intra-abdominal infection

Primary outcomes:
measure: Proportion of Subjects Who Experience a hemorrage
timeFrame: 10 min
Secondary outcomes:
measure: Proportion of Subjects Who Experience a Clinical and/or Radiologic Anastomotic Leak
timeFrame: 1-3 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji hospital affiliated to Shanghai jiaotong Uni school of medicine
Study officials:
References:
Clinical trial NCT01272921: The Use of Bupivacaine and Ropivacaine for Sciatic Nerve Block
Official title: A Dose Response Study for Duration of Analgesia Using Bupivacaine and Ropivacaine for Infragluteal Parabiceps Sciatic Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: The Duration of Motor Block May Vary Between 12-36 Hrs
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2011-01-10
Enrollment: 142
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: SUPPORTIVE_CARE

Brief summary: The duration of motor block for infragluteal parabiceps sciatic nerve block following total knee replacement may vary between 12-36 hrs depending on the amount of local anesthetic given.


Eligibility criteria: Inclusion Criteria:

* Adult patients (\>18 years of age) who are undergoing elective total knee arthroplasty will be included in the study.

Exclusion Criteria:

* Exclusion criteria for the study are patient refusal to be included in the study, contraindications to regional anesthesia, history of allergy to amide local anesthetics, the presence of a progressive neurological deficit, the presence of coagulopathy or infection, or pregnancy

Primary outcomes:
measure: Duration of Motor and Sensory Block of the Sciatic With 0.5% Bupivacaine and Ropivacaine After Ultrasound-guided Nerve-stimulator-Assisted Needle Positioning Beneath the CIEL
timeFrame: 3 days
Secondary outcomes:
measure: Cumulative Probabilities for Needle Positioning Above and Below CIEL.
timeFrame: 1 Day
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University, Feingberg School of Medicine
state: Illinois
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: Antoun Nader, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nader A, Kendall MC, De Oliveira GS Jr, Puri L, Tureanu L, Brodskaia A, Asher Y, Parimi V, McCarthy RJ. A dose-ranging study of 0.5% bupivacaine or ropivacaine on the success and duration of the ultrasound-guided, nerve-stimulator-assisted sciatic nerve block: a double-blind, randomized clinical trial. Reg Anesth Pain Med. 2013 Nov-Dec;38(6):492-502. doi: 10.1097/AAP.0b013e3182a4bddf.
Clinical trial NCT02258321: Phase 1 Study of Relative Bioavailability of PPI-668 New Tablet Versus Capsule Formulations
Official title: A Phase 1, Open-Label, Crossover Study to Evaluate the Relative Bioavailability of a New Tablet Formulation Versus the Current Capsule Formulation of PPI-668 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetic Assessments in Healthy Volunteers
Lead sponsor: Presidio Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2014-10-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study will compare the blood levels of PPI-668 resulting from two different formulations - the current capsule and a new tablet, T003.


Eligibility criteria: Inclusion Criteria:

* Have the ability to understand and sign a written informed consent form
* nonsmoker
* body mass index (BMI) of 18.0 to 29.9 kg/m2 (inclusive)
* HIV-1 antibody negative.
* hepatitis B (HBV) surface antigen negative.
* hepatitis C (HCV) antibody negative.

Exclusion Criteria:

* Pregnant or lactating subjects.
* Have any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with subject treatment, assessment, or compliance with the protocol. This would include renal, cardiac, hematologic, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central or peripheral nervous, gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), or immunodeficiency disorders, active infection, or malignancy that is clinically significant or requiring treatment.
* Have participated in an investigational trial involving administration of any investigational compound within 30 days prior to the study dosing.
* Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance.
* Have poor venous access and unable to donate blood.
* Have donated blood within 56 days of study dosing.
* Have donated plasma within 7 days of study dosing.
* Have taken any prescription medications or over-the-counter medications including herbal products within 28 days of commencing study drug dosing with the exception of vitamins and/or acetaminophen and/or ibuprofen and/or contraceptive medications.

Primary outcomes:
measure: PPI-668 area under the curve from time zero to infinity (AUC 0-inf)
timeFrame: days 1-8
measure: PPI-668 maximum observed plasma concentration (Cmax)
timeFrame: Days 1-8
measure: PPI-668 area under the curve from time zero to the last quantifiable concentration (AUC 0-t)
timeFrame: Days 1-8
Secondary outcomes:
measure: assessments of adverse events
timeFrame: days 1-8
measure: assessments of composite of clinical laboratory parameters
timeFrame: days 1-8
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Buffalo Clinical Research Center
state: New York
Study officials:
affiliation: Presidio Pharmaceuticals
name: Nathaniel Brown, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03748121: Yoga/Pranayama for Posttraumatic Stress Disorder
Official title: Pranayama Assisted Psychotherapy in Patients With Post-traumatic Stress Disorder: a Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: Posttraumatic Stress Disorder
Cognitive-Behavioral Therapy
Complementary Therapies
Yoga
Pranayama
Effectiveness
Safety
Randomized Controlled Trial
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2018-11-20
Enrollment: 74
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: This study aims to investigate the effect of a pranayama focused yoga intervention on post-traumatic symptom severity in patients with post-traumatic stress disorder undergoing standard psychotherapy/ trauma-focused cognitive-behavioral therapy (TF-CBT). Therefore, short pranayama sessions of 5-10 minutes will be provided to the patients directly at the begin of each of standard TF-CBT unit, while the control group will get standard TF-CBT alone. It should further be investigated, whether pranayama can enhance the affective tolerance of patients with post-traumatic stress disorder towards the used exposure techniques of TF-CBT.


Eligibility criteria: Inclusion Criteria:

* Diagnosed PTSD according to ICD-10
* PCL-5 Score of at least 33 points
* Undergoing outpatient CBT
* Physical and mental ability to perform Pranayama

Exclusion Criteria:

* Severe comorbid mental or somatic disease that did not allow the patient to perform Pranayama
* Pregnancy
* Regular practice of Yoga or Pilates in the last 12 months

Primary outcomes:
measure: Intensity of posttraumtic symptoms
timeFrame: week 10
Secondary outcomes:
measure: Health-related quality of life
timeFrame: week 10
measure: Ability of social participation
timeFrame: week 10
measure: Anxiety
timeFrame: week 10
measure: Depression
timeFrame: week 10
measure: Distress Tolerance
timeFrame: week 10
measure: Emotion Regulation
timeFrame: week 10
measure: Body Awareness
timeFrame: week 10
measure: Breath Holding Duration
timeFrame: week 10
measure: Acute Emotional Stress
timeFrame: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10
measure: Adverse Events
timeFrame: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10
Other outcomes:
measure: Treatment Expectation
timeFrame: week 0
Locations:
city: Neuss
country: Germany
facility: Dietmar Mitzinger
state: NRW
Study officials:
affiliation: University of Duisburg-Essen
name: Gustav Dobos, Prof. MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00314821: Ropinirole in the Treatment of Bipolar Depression
Official title: A Randomized, Double-blind, Placebo-controlled Study of the Efficacy of Ropinirole in the Treatment of Depression in Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar Disorder
Keywords: bipolar disorder, ropinirole, depression
Lead sponsor: Cambridge Health Alliance
Sponsor class: OTHER
Collaborators: name: Emory University
name: GlaxoSmithKline
First posted: 2006-04-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To demonstrate efficacy and safety of Requip in in treating bipolar depression.

Detailed description: This study is 8 weeks long, with an optional additional 8 weeks. The study is placebo-controlled and patients are randomized to receive either ropinerol or placebo. Changes in depression, anxiety and overall psychiatric symptoms will be monitored during participation.

Eligibility criteria: Inclusion Criteria:

* Meet DSM-IV criteria for bipolar disorder
* Current MADRS score \> 16
* Current MRS-SADS score \< 10
* Prior to participation in this study, each subject must sign an informed consent.
* All patients will be required to also take at least one other mood-stabilizing agent, defined as a standard agent (lithium, valproate, carbamazepine) or a novel anticonvulsant agent (oxcarbazepine, gabapentin, topiramate). If patients are not taking any of these agents on study initiation, they will be required to start one of these agents at study initiation. Study inclusion criteria must be met after at least 2 weeks of treatment with one of these mood-stabilizing agents.

Exclusion Criteria:

* Any serious acute medical illness
* Any clinically serious evidence of suicidality or score of 3 or greater on suicide item on MADRS scale

Primary outcomes:
measure: Primary outcome will be group differences between Requip and placebo in random effects linear regression analysis.
Secondary outcomes:
measure: The secondary outcomes will include predictors of response, such as insight into illness, comorbid anxiety symptoms, prior course of illness, previous treatment history with antidepressants, and other relevant clinical and demographic features.
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Cambridge
country: United States
facility: Cambridge Health Alliance
state: Massachusetts
Study officials:
affiliation: Cambridge Health Alliance
name: Robert T Dunn, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: