louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03232619: CD19-CART Treatment for ALL
Official title: Safety and Efficacy Evaluation of CD19-CART Treatment for Refractory or Recurrent ALL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acute Leukemia
Lead sponsor: Bioray Laboratories
Sponsor class: INDUSTRY
Collaborators: name: Second Xiangya Hospital of Central South University
First posted: 2017-07-28
Enrollment: 4
Sex: ALL
Minimum age (years): 6
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Enrolled patients will receive CD19-CART cell immunotherapy.
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the safety and efficacy of a novel CD19-CART in the treatment of refractory or recurrent ALL.

Detailed description: Chimeric antigen receptor T cell (CART) is a kind of engineered immunotherapy by transferring an artificial antigen binding receptor and also intercellular co-stimulating molecules into T cells. This kind of engineered T cells gains the ability to recognize antigen specific tumor cells and initiate the killing process in a HLA-independent way. CD19 is the specific cellular marker of B lineage acute leukemia (B-ALL), thus CD19-CART will be efficient in treating B lineage ALL. The investigators have constructed two kinds of CD19-CART. One is equipped with a murine CD19 scFv (single-chain variable fragmentt), while the other with a humanized scFv. This study aims to evaluate the safety and efficacy of both murine and humanized CD19-CART in treating refractory or recurrent ALL.

Eligibility criteria: Inclusion Criteria:

1. previously identified as CD19+ ALL.
2. ALL patients not eligible for allogeneic SCT or relapse after allogeneic SCT.
3. Expected survival \>12W.
4. Creatinine \< 2.5 mg/dl.
5. Alanine transaminase (ALT)/Aspartate Aminotransferase (AST) \< 3x normal
6. Bilirubin \<2.0 mg/dl
7. Voluntary informed consent is given.

Exclusion Criteria:

1. Pregnant or lactating women.
2. Uncontrolled active infection.
3. Active hepatitis B or hepatitis C infection.
4. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
5. Previously treatment with any gene therapy products.
6. Any uncontrolled active medical disorder that would preclude participation as outlined.
7. HIV infection.

Primary outcomes:
measure: Radiological assessment
timeFrame: Month1 to Month12
Secondary outcomes:
measure: The safety of CART immunotherapy
timeFrame: Day 1 to Week 4
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Bioray Inc.
state: Shanghai
Study officials:
affiliation: Second Xiangya Hospital of Central South University
name: Yunxiao Xu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00887419: Spinal Cord Stimulator Implant Study
Official title: Pain Coping Skills Training for Spinal Cord Stimulator Implant Candidates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Keywords: chronic back pain
spinal cord stimulator implant
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2009-04-24
Enrollment: 101
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 study is for patients who have been approved by their doctors and insurance companies to receive spinal cord stimulator implants.

The goal of this study is to investigate if pain and disability is improved in patients with an implant in combination with coping skills training. These patients are compared with those with an implant that receive chronic education information and those with an implant that are in the control group and receive no additional training or information.

Detailed description: This study tests the hypotheses that a pain coping skills program in combination with an SCS implant can improve short- and long-term outcomes in self-efficacy for coping with chronic pain, physical disability, psychological distress, and pain intensity.

Participants are patients who have been approved by their doctors and insurance companies to receive the spinal cord stimulator trial. After patients have been approved, they can be enrolled in this study. After completing a baseline evaluation, patients are randomized into (1)six individual pain coping skills training sessions(relaxations techniques, communication skills, goal setting), (2) six individual chronic pain education sessions (discussion approach to etiology and treatment of chronic pain and information on spinal cord stimulator implants, or (3) treatment as usual (no study intervention).

Participants are evaluated prior to or shortly after their surgery, at post treatment, at 6 month follow-up and at 12 month follow-up. All participants continue their routine medical care throughout the study.

Eligibility criteria: Inclusion Criteria

* daily back pain for 6 months or more
* approved by physician and psychologist for implant
* ability to read and write English
* at least 18 years old

Exclusion Criteria:

* pending litigation
* not approved for implant

Primary outcomes:
measure: Improvements in pain, psychological distress, and physical disability
timeFrame: Pre-intervention, post-intervention, 6 month, and 12 month follow-ups
Secondary outcomes:
measure: Patients will learn a repertoire of coping skills which can be applied to other challenges in life.
timeFrame: Pre-intervention, post intervention, 6 month, and 12 month follow-ups
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Laura Porter, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00653419: Bioavailability Study of (Buspar) Buspirone HCl Tablets Under Fasting Conditions
Official title: Comparative, Randomized, Single-Dose, 2-Way Crossover Bioavailability Study of Par and Bristol-Myers Squibb (Buspar) 15 mg Buspirone HCl Tablets in Healthy Adult Males Under Fasting Conditions Following Administration of a 30 mg Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: To Determine Bioequivalence Under Fasting Conditions
Keywords: bioequivalence
buspirone HCl
fasting
Lead sponsor: Par Pharmaceutical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Phoenix International Life Sciences, Inc.
First posted: 2008-04-04
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: To compare the single-dose bioavailability of Par and Bristol-Myers Squibb Buspirone HCl Tablets

Detailed description: To compare the single-dose bioavailability of Par and Bristol-Myers Squibb (Buspar) 15 mg Buspirone HCl Tablets under fasting conditions, following administration of a 30 mg dose

Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers, 18-45 years of age
* Weighing at least 60 kg, who are within 10% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983)
* Physical examination and laboratory tests of hematologic, hepatic and renal functions
* Medically healthy subjects with clinically normal laboratory profiles will be enrolled in the study

Exclusion Criteria:

* History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease
* The presence of alcoholism or drug abuse within the past year
* Hypersensitivity or idiosyncratic reaction to buspirone HCl
* Subjects who have been receiving monoamine oxidase inhibitors
* Subjects who have been on an abnormal diet (for whatever reason) during the 28 days preceding the study
* Subjects who, through completion of the study, would have donated in excess of 500 mL blood in 14 days, or 500-750 mL of blood in 14 days (unless approved by Principal Investigator, 1000 mL blood in 90 days, 1250 mL blood in 120 days, 1500 mL blood in 180 days, 2000 mL blood in 270 days, 2500 mL blood in 1 year
* Subjects who have participated in another clinical trial within 28 days of study start

Primary outcomes:
measure: Rate and extent of absorption
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: St-Laurent
country: Canada
facility: Phoenix International Life Sciences, Inc.
state: Quebec
Study officials:
affiliation: Phoenix International Life Sciences, Inc.
name: Samuel Serfaty, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00497419: Reperfusion Time in ST Segment Elevation Myocardial Infarction (STEMI)
Official title: Evaluation of a Fast Track for Patients With STEMI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Keywords: STEMI
ST elevation myocardial infarction
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2007-07-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Reperfusion delay in STEMI has been shown to be excessive in our community. In order to improve delay a fast track (direct transfer in catheterization laboratory) has been implemented. The present study aims at evaluating the benefits of this procedure.

Detailed description: Reperfusion delay in STEMI has been shown to be excessive in our community. Admission in emergency room and waiting for transfer to catheterization laboratory seems to be the principal source of delay. In order to improve delays a fast track (direct transfer in catheterization laboratory) has been implemented for patients being diagnosed with STEMI by emergency physician out of hospital. The present study aims at evaluating the benefits of this procedure.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of STEMI

Exclusion Criteria:

* On site resuscitated patients

Primary outcomes:
measure: Door to balloon time
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospital, Emergency Service
Study officials:
affiliation: University Hospital, Geneva
name: Olivier Grosgurin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grosgurin O, Plojoux J, Keller PF, Niquille M, N'koulou R, Mach F, Sarasin FP, Rutschmann OT. Prehospital emergency physician activation of interventional cardiology team reduces door-to-balloon time in ST-elevation myocardial infarction. Swiss Med Wkly. 2010 Apr 17;140(15-16):228-32. doi: 10.4414/smw.2010.12927.
Clinical trial NCT02847819: Vocal Cord Movement Assessment Using Airway Ultrasound.
Official title: Pre and Post-operative Evaluation of Vocal Cord Movement in Patients Undergoing Thyroid Surgery by Airway Ultrasound Scanning.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vocal Cord Movement Assessment by Airway Ultrasound
Lead sponsor: Rajiv Gandhi Cancer Institute & Research Center, India
Sponsor class: OTHER
First posted: 2016-07-28
Enrollment: 104
Sex: ALL
Minimum age (years): 17
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing thyroid surgery.

Brief summary: Total of 100 patients are included in this is a prospective observational study to evaluate the role of airway ultrasound (USG) in assessing vocal cord mobility in patients undergoing thyroid surgery. patients will be scanned preoperatively by airway ultrasound which will be compared to post operative ultrasound scans.

Detailed description: All 100 patients between age groups of 15-70 years, will be scanned pre-operatively to see vocal cord mobility as a reference value. A proper acoustic window is mandatory for optimal visualization of laryngeal structures. Visibility of false vocal cords, true vocal cords and arytenoids will be given one point each for one side, maximal score will be 6. According to points the acoustic window scoring for glottis aperture will be graded as fair, when both false vocal cords are visible (score1-2), along with false cord when both arytenoids are visible scored good (score3-4) and if single or both true vocal cords are visible then scored as very good(score5-6). After the surgery the same patient will be scanned again for vocal cord mobility at 4hours of extubation . Any change in mobility will be recorded. If any change will be observed, direct laryngoscopy (DL) will be done to confirm the diagnosis. Any complication in the post-operative period will be recorded.

Eligibility criteria: Inclusion Criteria:

* patients undergoing thyroid surgery between specified age limits.

Exclusion Criteria:

* Retro sternal goiters.

Primary outcomes:
measure: Objective confirmation of vocal cords movement
timeFrame: pre operatively and at 4 hours after extubation
Secondary outcomes:
measure: Comparison of preoperative doppler velocity with post operative doppler velocity.
timeFrame: At 4 hours after extubation.
Other outcomes:
Locations:
city: Delhi
country: India
facility: Rajiv Gandhi Cancer Institute & Research center
state: New Delhi
Study officials:
affiliation: Rajiv Gandhi Cancer Institute & Research Centre, Rohini; New Delhi: India 110085.
name: Mamta Dubey, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dubey M, Mittal AK, Jaipuria J, Arora M, Dewan AK, Pahade A. Functional analysis of vocal folds by transcutaneous laryngeal ultrasonography in patients undergoing thyroidectomy. Acta Anaesthesiol Scand. 2019 Feb;63(2):178-186. doi: 10.1111/aas.13234. Epub 2018 Aug 5.
Clinical trial NCT01293019: Osteopathic Treatment in Adult Patients With Cystic Fibrosis
Official title: Impact of an Osteopathic Manipulative Treatment on Pain of Adult Patients With Cystic Fibrosis - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cystic Fibrosis
Back Pain
Neck Pain
Chest Pain
Keywords: Complementary and alternative medicine
Osteopathic treatment
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Vaincre la Mucoviscidose
First posted: 2011-02-10
Enrollment: 32
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: To study the contribution of osteopathy on the reduction of pain in adult patients with cystic fibrosis

Detailed description: To compare the impact of osteopathic treatment to a placebo of osteopathic treatment and to usual care on pain at 6 months in adult patient with cystic fibrosis localized to chest, cervical, dorsal neck or back.

Eligibility criteria: Inclusion criteria :

* Diagnosis of cystic fibrosis ( positive sweat test and / or presence of 2 disease causing mutations in the CFTR gene
* Age \> 18 years
* Patient with chronic chest , neck or back pain
* Written Informed Consent
* with health insurance

Exclusion criteria :

* regular follow-up by an osteopathic physician in the previous 3 months
* patients awaiting lung transplantation
* history of lung transplantation
* pregnancy
* understanding disorders preventing the patient to apply the study
* participation in another clinical interventional study protocol

Primary outcomes:
measure: Pain score
timeFrame: at 6 months
Secondary outcomes:
measure: quality of life scores
timeFrame: at 6 months
measure: Co-interventions
timeFrame: at 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Cochin Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Dominique Hubert, MD
role: STUDY_CHAIR
References:
citation: Hubert D, Soubeiran L, Gourmelon F, Grenet D, Serreau R, Perrodeau E, Zegarra-Parodi R, Boutron I. Impact of osteopathic treatment on pain in adult patients with cystic fibrosis--a pilot randomized controlled study. PLoS One. 2014 Jul 16;9(7):e102465. doi: 10.1371/journal.pone.0102465. eCollection 2014.
Clinical trial NCT04517019: Randomised Trial Evaluating the Benefit of a Fitness Tracker Based Workout During Radiotherapy
Official title: Randomisierte Studie Zum Nutzen Eines Fitnesstracker Basierten Aktivitätstrainings während Einer Strahlentherapeutischen Behandlung (OnkoFit II Studie)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bronchial Carcinoma
Esophageal Carcinoma
Tumor of the Brain
Head and Neck Cancer
Pancreas Cancer
Sarcoma
Cervix Uteri Cancer
Keywords: Fatigue
Activity tracker
Radiotherapy
Exercise
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2020-08-18
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Evaluation of the impact of an activity tracker based fitness programme on the Qualitiy of Life after oncological therapy.

Detailed description: This monocentric, three-arm, randomized, controlled clinical trial evaluates the effect of an activity tracker based exercise program in cancer patients on the Quality of life after oncological therapy. Quality of Life and the intensity of fatigue will be documented with the FACT-G total score of the FACIT Questionnaire six months after completion of radiotherapy.

Eligibility criteria: Inclusion Criteria:

* Capacity for consent
* Minimum age 18
* Presence of one of the following tumor diseases: Bronchial Carcinoma, Esophageal Carcinoma, Tumor of the Brain, Head and Neck Cancer, Pancreas Cancer, Sarcoma Cervix Uteri Cancer
* ECOG 0-2
* Indication for a radiotherapy or a radiochemotherapy with an intended treatment time of minimum 4 weeks (definitive/adjuvant/neoadjuvant)

Exclusion Criteria:

* Participation in any other interventional study
* Radiotherapy of Breast cancer
* Pregnancy
* Contraindication against physical activity/sport and others
* Severe cardiovascular pre-existing conditions (after myocardial infarction, apoplexy in the last 6 months, congestive heart failure NYHA \> I°)
* preexisting diseases with are relevantly accompanied by a limited mobility in patients (e.g. paraparesis of the lower limbs)
* ECOG Status 3-4
* prior use of activity trackers

Primary outcomes:
measure: Evaluation of the impact of an Activity tracker based Fitness programme on the Qualitiy of Life after oncological Therapy
timeFrame: 6 Months after completion of adjuvant radiotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University Hospital Tübingen
state: Baden-Württemberg
Study officials:
affiliation: University Hospital Tübingen
name: Cihan Gani, MD, PD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hauth F, Gehler B, Niess AM, Fischer K, Toepell A, Heinrich V, Roesel I, Peter A, Renovanz M, Hartkopf A, Stengel A, Zips D, Gani C. An Activity Tracker-Guided Physical Activity Program for Patients Undergoing Radiotherapy: Protocol for a Prospective Phase III Trial (OnkoFit I and II Trials). JMIR Res Protoc. 2021 Sep 22;10(9):e28524. doi: 10.2196/28524.
Clinical trial NCT01716819: Role of the Renin Angiotensin Aldosterone System in the Mechanisms of Transition to Heart Failure in Abdominal Obesity
Official title: Role of the Renin Angiotensin Aldosterone System and Remodeling of the Matrix Cardiac Extra Cellular in the Mechanisms of Transition to Heart Failure in Abdominal Obesity: Prospective Longitudinal Study R2C2 II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Abdominal
Keywords: Heart failure, abdominal obesity, RAAS
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2012-10-30
Enrollment: 101
Sex: ALL
Minimum age (years): 43
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: R2C2 study has shown that abdominal obesity is associated with a cardiac and vascular remodelling in healthy volunteers. This remodelling is correlated with renin-angiotensin aldosterone system (RAAS) activation and/or systemic fibrosis. R2C2 II study is designed to confirm the hypothesis that RAAS is associated with an early remodelling and implicated in the transition to cardiac failure in abdominal obesity.

Detailed description: Follow up of abdominal obesity patients from the R2C2 cohort study.

Eligibility criteria: Inclusion Criteria:

* Being a former member of R2C2 study, abdominal obese group.
* Having signed the informed consent (refusing to participate to the genetic study is not an exclusion criteria).
* being affiliated to health insurance scheme.

Inclusion Criteria of R2C2 study:

* Men and women aged between 40 and 65 year's old
* Caucasian
* Born or living in France for at least 10 years
* Presenting an abdominal obesity defined by a waist circumference \>94 cm in men and ≥ 80 cm in women, associated or not with untreated hypertension or hypertension treated for less than one year
* Having signed the informed consent

Exclusion Criteria:

* Subjects unable to understand the information letter
* Subjects under supervision or guardianship
* pregnant or lactating woman
* A contraindication to perform MRI is not an exclusion criteria.

Primary outcomes:
measure: cardiac extracellular matrix remodelling
timeFrame: 3-7 years
Secondary outcomes:
measure: Cardiac and arterial phenotype
timeFrame: 3-7 years
Other outcomes:
Locations:
city: Vandoeuvre Lès Nancy
country: France
facility: CIC-P - INSERM - Institut Lorrain du Cœur et des vaisseaux
state: Meurthe et Moselle
Study officials:
affiliation: CIC-P - INSERM - Institut Lorrain du Cœur et des vaisseaux Louis Mathieu
name: Patrick ROSSIGNOL
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mandry D, Girerd N, Lamiral Z, Huttin O, Filippetti L, Micard E, Beaumont M, Ncho Mottoh MB, Pace N, Zannad F, Rossignol P, Marie PY. Relationship Between Left Ventricular Ejection Fraction Variation and Systemic Vascular Resistance: A Prospective Cardiovascular Magnetic Resonance Study. Front Cardiovasc Med. 2021 Dec 24;8:803567. doi: 10.3389/fcvm.2021.803567. eCollection 2021.