louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03436771: Long-term Follow-up Study for Patients Previously Treated With a Juno CAR T-Cell Product
Official title: Long-Term Follow-up Protocol for Subjects Treated With a CAR T-Cell Product on a Juno-Sponsored Clinical Trial
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Non Hodgkin Lymphoma
Multiple Myeloma
Chronic Lymphocytic Leukemia
Diffuse Large B Cell Lymphoma
Mantle Cell Lymphoma
Follicular Lymphoma
Keywords: long-term follow-up
chimeric antigen receptor (CAR) T cells
JCAR017
JCARH125
Lead sponsor: Juno Therapeutics, a Subsidiary of Celgene
Sponsor class: INDUSTRY
First posted: 2018-02-19
Enrollment: 4
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: Patients previously treated with a Juno CAR T-cell product on a Juno-sponsored clinical trial

Brief summary: This study will provide long-term follow-up for patients who have received treatment with a Juno CAR T-cell product in a Juno-sponsored clinical trial. In this study, patients will be followed for up to 15 years after their last dose of Juno CAR T cells for evaluation of delayed adverse events, presence of persisting CAR T-cell vector sequences, presence of replication-competent retrovirus (RCR) or lentivirus (RCL), and survival.


Eligibility criteria: Inclusion Criteria:

* Patients who have received at least one dose of a Juno CAR T-cell product (listed above) in a Juno-sponsored clinical trial
* Patients who have provided informed consent for the long-term follow-up study

Exclusion Criteria:

* None. All patients who have previously received treatment with a Juno CAR T-cell product are eligible for this long-term follow-up study.

Primary outcomes:
measure: Proportion of patients with adverse events
timeFrame: 15 years from last treatment
measure: Proportion of patients with detectable viral vector sequences
timeFrame: 15 years from last treatment
measure: Proportion of patients with detectable RCR or RCL
timeFrame: 15 years from last treatment
Secondary outcomes:
measure: Overall survival
timeFrame: 15 years from last treatment
measure: Progression-free survival
timeFrame: 15 years from last treatment
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Sponsor GmbH
name: Jacob Garcia, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04888871: Comparison of Prevention and Appropiate Obstetric Interventions for Prolonged Second Stage Labor at Term Pregnancies During Vaginal Delivery
Official title: Randomized Control Trial for Comparison of Prevention and Appropiate Obstetric Interventions for Prolonged Second Stage Labor at Term Pregnancies During Vaginal Delivery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obstetric Labor Complications
Vacuum Extraction; Failure, Affecting Fetus or Newborn
Complicated Labour/Delivery Livebirth
Keywords: labor stage, second
Lead sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Sponsor class: OTHER
First posted: 2021-05-17
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Randomized Control Trial for Comparison of Prevention and Appropiate Obstetric Interventions for Prolonged Second Stage Labor at Term Pregnancies During Vaginal Delivery.

Brief summary: Randomized Control Trial for Comparison of Prevention and Appropiate Obstetric Interventions for Prolonged Second Stage Labor at Term Pregnancies During Vaginal Delivery.

Detailed description: This study includes prolonged second stage phase and not prolonged second phase in pregnant women to singletons at the weeks between 37-42. Fetal head level will be at or below the ischial spines in all patients.Patients with fully dilated cervix will be included in the study and the bladder will be emptied completely on the labor table. Patients diagnosed with fetal distress will not be included in the study.Indicated patients will be randomly divided into three groups; one group will be only subjected to a Fundal Pressure (Kristaller Maneuver), second group will only be subjected to Vacuum Extraction and the third group will be subjected to both Fundal Pressure (Kristaller Maneuver) and Vacuum Extraction. Maternal episiotomy needs presence of second and third degree perineal tears, presence of postpartum hemorrhage and need for blood transfusion , cesarean rates and fetal first and fifth minute Apgar score , fetal blood gas parameters, presence of fetal trauma, need for neonatal intensive care will be evaluated among three randomized groups.

Eligibility criteria: Inclusion Criteria:

* term pregnancy weeks between 37-42, singleton, vertex presentations
* prolonged second stage of labor
* Fetal head is minimum at the level of ischial spin
* maternal incompatibility during/after second stage of labor
* complete cervical dilatation

Exclusion Criteria:

* Fetal distress
* Uncomplete cervical dilatation
* twin pregnancies or polycyesia
* Pregnancy weeks lower than 37weeks
* other than vertex presentations
* Fetal Anomalies

Primary outcomes:
measure: maternal morbidity
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Zeynep Kamil Maternity and Childrens Hospital
state: Uskudar
Study officials:
References:
Clinical trial NCT04051671: Effects of Dual-transcranial Direct Current Stimulation During Physical Therapy in Sub-acute Stroke
Official title: Effects of Dual-transcranial Direct Current Stimulation During Physical Therapy in Sub-acute Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: National Research Council of Thailand
First posted: 2019-08-09
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to evaluate the possible effect of using dual-tDCS applied during conventional physical therapy on lower limb function in stroke patients.

Detailed description: Recently dual-tDCS applied before the conventional physical therapy show positive effect of lower limb performance. However to explore the time during which dual-tDCS can be combined with physical therapy to maximize motor performance is required. Results from the present study with be compared with our previous study that used dual-tDCS applied before physical therapy.

Eligibility criteria: Inclusion Criteria:

1. Age range 18-75 years.
2. First ever-ischemic lesion in the territory of middle cerebral artery or anterior cerebral artery. CT scan/MRI result is thus required.
3. Sub acute phase of stroke (less than 6 months)
4. Able to sit-to-stand and stand-to-sit independently
5. Able to walk without physical assistance at least 6 m
6. Free of any neurological antecedent, unstable medical conditions or condition that may increase the risk of stimulation such as epilepsy

Exclusion Criteria:

1. Pre-stroke disability
2. Pregnant
3. Be unable to understand the instruction
4. No clear neurological antecedent history or psychiatric disorder
5. Excessive pain in any joint of the paretic limb (numerical pain rating score \> 7)
6. Presence of intracranial metal implantation, cochlea implant, or cardiac pacemaker
7. Subjects are participating in the other protocol or receiving alternative treatment such as acupuncture

Primary outcomes:
measure: Five-Times-Sit-To-Stand test (FTSST)
timeFrame: 5 minutes
measure: Timed Up & Go test (TUG)
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Salaya
country: Thailand
facility: Faculty ofPhysical Therapy, Mahidol University
state: Nakonpathom
Study officials:
References:
citation: Klomjai W, Aneksan B. A randomized sham-controlled trial on the effects of dual-tDCS "during" physical therapy on lower limb performance in sub-acute stroke and a comparison to the previous study using a "before" stimulation protocol. BMC Sports Sci Med Rehabil. 2022 Apr 15;14(1):68. doi: 10.1186/s13102-022-00463-9.
Clinical trial NCT04816071: Essential Amino Acid Supplementation in Older Adult COVID-19 Patients
Official title: Essential Amino Acid Supplementation in Older Adult COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Covid19
Keywords: Amino acid supplement
Dietary supplement
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2021-03-25
Enrollment: 0
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A 4-week treatment of essential amino acids or placebo to participants with: 1) negative COVID-19 test with exposure, or 2) positive COVID-19 test and no or mild symptoms. The study team will measure change in symptoms. Participants will complete symptom surveys for 4 weeks and once at 8 and 12 weeks as well as pre- and post-assessments.

Detailed description: In people who have been exposed to COVID-19 and have been tested (positive or negative) with no to mild symptoms, the study team will administer a treatment of essential amino acids (EAA). The study team will examine if this treatment compared to placebo will reduce the development, length and the severity of symptoms. Participants will consume the treatment or placebo for 4 weeks, and will complete symptom surveys, as well as pre- and post-assessments. Individuals who receive a COVID vaccination will continue to complete symptom surveys for 1 week and take the essential amino acid supplementation for 2 weeks following a vaccination.

Eligibility criteria: Inclusion Criteria:

* Exposure to COVID-19 in the last 60 days with no symptoms, with a COVID negative test Close contact: within 6 feet of a COVID-19 positive person for more than a few minutes without wearing PPE, or having direct contact with infectious secretions without PPE
* Positive COVID-19 test with or without symptoms

Exclusion Criteria:

* COVID-19 positive hospitalized patient
* Patients who have symptoms of COVID but have not been tested.
* Unable to tolerate oral intake
* In hospice or palliative care
* Unstable medical or psychiatric condition
* Other criteria deemed acceptable by principle investigator

Primary outcomes:
measure: Improvement in symptoms
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Gohar Azhar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05577871: Dexmedetomidine in Off Pump Coronary Artery Bypass Grafting
Official title: Echocardiographic Evaluation of the Effect of Dexmedetomidine Infusion as an Adjuvant to General Anesthesia in Off-pump Coronary Artery Bypass Grafting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 36
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the study will assess the impact of intraoperative dexmedetomidine infusion on myocardial performance by investigating the left ventricular (LV) systolic and diastolic function and right ventricular (RV) fraction area change (which reflect RV systolic function) using two-dimensional trans-esophageal echocardiography (TEE) in patients undergoing elective first-time isolated off-pump coronary artery bypass (OPCAB) grafting. LV Systolic function will be measured by the TEE via the fractional area change, fraction shortening, and ejection fraction.

Detailed description: Off pump coronary revascularization is an old technique performed first in St Petersburg in 1964, Off pump coronary artery surgery has been developed following two different approaches. Minimally invasive direct-access coronary artery bypass (MIDCAB) that consists of anastomosing the left internal mammary artery to the left anterior descending coronary artery through small anterior left thoracotomy, The second approach is multi-vessel grafting without CPB performed through standard median sternotomy. Dexmedetomidine (Dex), a highly selective α2-adrenergic receptor agonist, is widely used for sedation and analgesia in the ICU or as an anesthetic adjuvant.

This study will be a prospective comparative controlled randomized double blinded clinical trial on 36 patients divided into control ,and dexmedetomidine group.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective first-time off-pump isolated coronary artery bypass graft (OPCAB) surgery
* Patients with good ventricular functions.
* Patients with normal levels of cardiac troponin I and myocardial enzymes
* Patients of Body Mass Index (BMI) more than 20 and less than 34.

Exclusion Criteria:

* Severe functional liver or kidney disease.
* Diagnosed HF (NYHA class \>3).
* Arrhythmia or received treatment with anti-arrhythmic drugs.
* Severe bradycardia (HR \< 45 bpm) and AV block.
* Pathologic esophageal lesion (esophageal stricture or varix )
* Pregnancy.

Primary outcomes:
measure: left ventricular ejection fraction
timeFrame: immediatly after sternal closure
measure: left ventricular fractional shorting
timeFrame: immediatly after sternal closure
measure: left ventricular diastolic function
timeFrame: immediatly after sternal closure
Secondary outcomes:
measure: right ventricular systolic function
timeFrame: immediatly after sternal closure
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05406271: Hip Prosthesis Components Position
Official title: Influence of Use of Intraoperative Fluoroscopy on the Hip Prosthesis Components Position
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Arthrosis
Keywords: hip prosthesis
center of rotation
offset
Lead sponsor: Independent Public Healthcare Center in Rypin
Sponsor class: OTHER
First posted: 2022-06-06
Enrollment: 100
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: The purpose of the study is


Eligibility criteria: Inclusion Criteria:

* indication for hip replacement surgery

Exclusion Criteria:

* pregnancy
* abnormal anatomy (hip dysplasia, fracture)
* previous srgery

Primary outcomes:
measure: Prosthesis cup position
timeFrame: Day 1 after surgery
Secondary outcomes:
measure: Prosthesis steam position
timeFrame: Day 1 after surgery
Other outcomes:
Locations:
city: Rypin
country: Poland
facility: District Hospital
state: Kujawsko-pomorskie
Study officials:
References:
Clinical trial NCT00779571: The Female Health Dietary Intervention Study
Official title: Treatment of PCOS (Polycystic Ovary Syndrome)in Morbidly Obese Women - A Randomized Controlled Prospective Dietary Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Morbid Obesity
Keywords: Polycystic Ovary Syndrome
Morbid Obesity
Type 2 DM
Coronary heart disease
Lead sponsor: The Hospital of Vestfold
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
First posted: 2008-10-24
Enrollment: 61
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study has two phases:

1. In phase 1 of the study (8 weeks),the effect of two different low calorie diets on manifestations of PCOS, including risk factors for the metabolic syndrome and cardiovascular risk profile will be compared.
2. In phase 2 the long term effect (next 44 weeks) on sustained weight-loss and the above mentioned parameters will be compared and evaluated.

Detailed description: Weight loss is an important and effective treatment of morbidly obese women with PCOS. Effective weight reduction will improve manifestations of PCOS and risk factors for developing type 2 diabetes and coronary heart diseases. We compare the effect of two isocaloric low calorie diets (LCD), - one powder-based shake-diet and a fiber rich diet on the above mentioned parameters. In addition we want to compare the weight-maintenance effect the next 44 weeks of two different follow-up programs: A usual care- and a lifestyle-program.

Eligibility criteria: Inclusion Criteria:

* Woman (European Caucasian)
* PCOS
* BMI = or \> 35

Exclusion Criteria:

* Cushing syndrome
* Adrenal hyperplasia
* Androgen-producing tumors
* Anovulation caused by hyperprolactinemia
* Pregnancy, breast feeding
* Use of oral contraceptives/hormone treatment/insulin-sensitizing agents

Primary outcomes:
measure: Weight loss
timeFrame: One year
Secondary outcomes:
measure: Improvement of PCOS, diabetes type 2- and coronary heart disease-risk factors
timeFrame: one year
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Kvinneklinikken, Rikshospitalet-Radiumhospitalet HF
Study officials:
affiliation: The Hospital of Vestfold
name: Jøran Hjelmesæth, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo University Hospital
name: Tom Tanbo, MD, PhD
role: STUDY_CHAIR
affiliation: University of Oslo
name: Kirsten B Holven, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo University Hospital
name: Line Kristin Johnson, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Johnson LK, Holven KB, Nordstrand N, Mellembakken JR, Tanbo T, Hjelmesaeth J. Fructose content of low calorie diets: effect on cardiometabolic risk factors in obese women with polycystic ovarian syndrome: a randomized controlled trial. Endocr Connect. 2015 Sep;4(3):144-54. doi: 10.1530/EC-15-0047.
Clinical trial NCT06691971: AeviceMD for Detection of Wheeze in Pediatric and Adult Populations
Official title: A Pilot Study to Assess Aevice Medical Device for Detection of Wheeze in Pediatric and Adult Populations
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Subject Presenting Wheeze
Asthma
Bronchial Disease
Respiratory Tract Diseases
Pediatric Asthma
Chronic Respiratory Disease
Keywords: Wheeze
Auscultation
Wearable Medical Device
Lead sponsor: Aevice Health Pte. Ltd.
Sponsor class: OTHER
Collaborators: name: Montefiore Medical Center
First posted: 2024-11-18
Enrollment: 160
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study will include 160 Subjects (80 Pediatrics and 80 Adult Subjects) who are presenting with wheeze in the emergency department, and outpatient and inpatient settings

Brief summary: Respiratory signs and symptoms consisting of wheeze, cough, and breathlessness are obtained in a manual fashion through history taking and physical examination by the healthcare professional. Auscultation of the lung assesses airflow through the trachea-bronchial tree and is helpful in diagnosing various respiratory disorders. AeviceMD is a wearable device that can acquire and process lung sounds, thus assisting in the detection of abnormal lung sounds. The primary objective of this study is to determine if AeviceMD can detect wheeze of pediatrics and adults as accurately as a physician through auscultation. The secondary objective is to investigate if AeviceMD can be used for remote auscultation of breath sounds.


Eligibility criteria: Inclusion Criteria:

* The subject is willing and/or parents/guardians are able to give informed consent for participation in the study.
* Male or Female, aged ≥ 3 years.
* Diagnosed with acute asthma exacerbation by an ED provider.

Exclusion Criteria:

* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the subjects at risk because of participation in the study, or may influence the result of the study, or the subject's ability to participate in the study.

Primary outcomes:
measure: Wheeze is detected by physician and AeviceMD
timeFrame: 60 Seconds
Secondary outcomes:
measure: Respiratory sounds are detected and identified by onsite physician and offsite (remote) physician
timeFrame: 150 Seconds
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
References:
Clinical trial NCT00186771: Magnetic Stimulation as a Treatment for Auditory Hallucinations in Schizophrenia
Official title: Transcranial Magnetic Stimulation Used to Treat Auditory Hallucinations in Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Transcranial Magnetic Stimulation
Paired Pulse
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Schizophrenia is a chronic, severe, and disabling brain disease. Auditory hallucinations are the most frequent symptoms with an incident of 50% to 70% in patients.

Transcranial Magnetic Stimulation (TMS) can significantly reduce symptoms of schizophrenia. TMS is capable of inducing changes in the electrical activities of the brain in humans.

The purpose of this trial is to study the use of TMS to decrease auditory hallucinations in schizophrenia.

Detailed description: We hypothesize that: True treatment with rTMS will have significant decrease in auditory hallucinations versus sham treatment over the temporoparietal cortex.

FMRI will highlight areas of activation with auditory hallucinations distinct from the area identified by Hoffman's scalp based method.

Cortical inhibition as measured by paired pulse TMS will be increased after true TMS but not sham TMS.

Eligibility criteria: Inclusion Criteria:

* Schizophrenia
* Auditory hallucinations occuring more than 5 times per day
* Adequate (6 weeks) trial of antipsychotic medication
* Including at least 1 atypical antipsychotic medication
* Medication stable for 4 weeks prior to commencement of the study
* Competent to consent

Exclusion Criteria:

* history of seizure disorder in patient or first degree relative
* recent head injury
* Acute suicidality
* Alcohol or substance abuse
* Implanted pacemaker or metal in head or neck
* Pregnancy

Primary outcomes:
measure: Hoffman Auditory Hallucination Scale
timeFrame: weekly
Secondary outcomes:
measure: Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare, rTMS Laboratory, 100 West Fifth Street
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare, rTMS Laboratory, 100 West Fifth Street
state: Ontario
Study officials:
affiliation: St. Joseph's Health Care London
name: Gary Hasey, MD
role: PRINCIPAL_INVESTIGATOR
References: