louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05381662: CD19 Chimeric Antigen Receptors and CD19 Positive Feeder T Cells as a Leukemia Consolidation Treatment
Official title: CD19 Chimeric Antigen Receptors and CD19 Positive Feeder T Cells as a Leukemia Consolidation Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Acute Lymphoblastic Leukemia in Remission
Lead sponsor: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Sponsor class: INDUSTRY
Collaborators: name: The First Affiliated Hospital of Soochow University
First posted: 2022-05-19
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: This is a single center,randomized ,two-cohorts, open-label ,phase 1/2 study to evaluate the efficacy and safety of T cells expressing CD19 chimeric antigen receptors combined with CD19 positive feeder T cells treatment for CD19+ acute lymphoblastic leukemia patients in remission .

Detailed description: Patients were divided into two groups, group 1 and group 2, and each group was enrolled in 5 patients. Group 1 patients did not receive any pretreatment, and group 2 patients received pretreatment with cyclophosphamide and fludarabine prior to reinfusion. Then Patients were given Chimeric Antigen Receptor T-Cell( CAR-T) and CD19-positive T cells.

Eligibility criteria: Inclusion Criteria:

1. Age 18 to 65
2. Voluntary informed consent is given
3. Expected survival ≥12 weeks
4. Relieve CD19+ acute leukemia
5. Organ function: (1)Left ventricular ejection fractions≥ 0.6 by echocardiography (2)ALT ≤3 times of ULN, or bilirubin \<2.0 mg/dl (3)Creatinine \< 2 mg/dl and less than 2.5 × normal for age (4)Prothrombin time and activated partial thromboplastin time \< 2 times of ULN (5)Arterial oxygen saturation\> 92%
6. Karnofsky score ≥ 60 ;
7. No history of combined chemotherapy in the recent 1 month and no immunotherapy in the recent 3 months;

Exclusion Criteria:

1. Uncontrolled active infections
2. Active hepatitis B or hepatitis C infection
3. HIV infection
4. History of myocardio infarction in the past 6 months, or history of severe arrhythmia
5. Congenital immunodeficiency
6. Pregnant or lactating women
7. History or presence of clinically relevant CNS pathology such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
8. Previous treatment with any gene therapy products

Primary outcomes:
measure: Incidence of severe CRS
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The first affiliated hospital of soochow university
state: Jiangsu
city: Suzhou
country: China
facility: The first affiliated hospital of soochow university
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: Depei Wu, Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT00856362: Study Evaluating The Co-Administration Of Moxidectin And Midazolam In Healthy Subjects
Official title: An Open-label, Single-Dose, 4-Period, Sequential Study to Determine the Effect of Moxidectin on CYP3A4 Activity in Healthy Subjects Using Midazolam as a Probe Substrate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Subjects
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2009-03-05
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of single doses of midazolam on the plasma concentration of a single dose of moxidectin in healthy young adult subjects, and to assess the safety of co-administration of moxidectin and midazolam.


Eligibility criteria: Inclusion criteria:

1. Men or women of nonchildbearing potential (WONCBP) aged 18 to 50 years inclusive at screening.

   WONCBP may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for ≥1 year (with follicle-stimulating hormone \[FSH\] ≥38 mIU/mL) and must have a negative pregnancy test result within 48 hours before administration of test article. Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound. Sexually active men must agree to use a medically acceptable form of contraception during the study and continue it for 12 weeks after test article administration.
2. Body mass index in the range of 18 to 30 kg/m2 and body weight ≥50 kg.
3. Healthy as determined by the investigator on the basis of screening evaluations.

Exclusion criteria:

1. Women of childbearing potential.
2. Presence or history of any disorder that may prevent the successful completion of the study.
3. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.

Primary outcomes:
measure: Blood samples will be collected for determination of moxidectin and midazolam plasma concentrations
timeFrame: 4 months
Secondary outcomes:
measure: Safety based on adverse event monitoring, physical examinations, vital sign measurements, 12-lead electrocardiograms (ECGs) and routine lab tests
timeFrame: 4 months
Other outcomes:
Locations:
city: Berlin
country: Germany
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00211562: Adjunctive Supplementation of Antioxidants (Vitamins E + C) Plus Omega-3 Fatty Acids
Official title: Reduction of Body Weight in Olanzapine Treated Schizophrenia Patients by Adjunctive Supplementation of Antioxidants (Vitamins E + C) Plus Omega-3 Fatty Acids
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: weight gain
weight gain supplementation
antioxidants
olanzapine
Lead sponsor: Augusta University
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
name: Medical Service Line ABRC
name: US Department of Veterans Affairs
First posted: 2005-09-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This research study helps to demonstrate that adding vitamins and fats (nutritional supplements) to a diet will help reduce body weight and improve the lipid profile. This will be done by examining the body weight and chemicals in the blood. The chemicals are the result of the brain using the fat that subjects eat in their diet. Some medications may also change the amount of these chemicals in a person's blood.

Detailed description: To demonstrate that supplementation of antioxidants and omega-3 fatty acids will improve clinical outcome including cognitive performance in olanzapine treated patients.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 55
* VA outpatient
* Diagnosis of schizophrenia by DSM-IV criteria
* Active treatment with olanzapine
* Medically healthy

Exclusion Criteria:

* Diagnosis of MR
* MMSE score of \< 26
* Not on a stable dose of olanzapine

Primary outcomes:
measure: PANSS
timeFrame: 2003-2006
measure: BMI
timeFrame: 2003-2006
measure: Blood samples
timeFrame: 2003-2006
Secondary outcomes:
measure: Cognitive assessments
timeFrame: 2003-2006
Other outcomes:
Locations:
city: Augusta
country: United States
facility: VA Medical Center
state: Georgia
Study officials:
affiliation: VA MC/Medical College of Georgia
name: Peter Buckley, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jones B, Basson BR, Walker DJ, Crawford AM, Kinon BJ. Weight change and atypical antipsychotic treatment in patients with schizophrenia. J Clin Psychiatry. 2001;62 Suppl 2:41-4.
Clinical trial NCT06390891: Role of Patient Selection for Pancreatic Resections
Official title: Importance of Patient Characteristics in Identifying and Selecting Patients Suitable for Pancreatic Resection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreas Disease
Keywords: Specialization
Pancreatic Surgery
Resection
Volume-Outcome-Relationship
Lead sponsor: Medizinische Hochschule Brandenburg Theodor Fontane
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 86073
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population encompasses all patients that underwent any pancreatic resection procedure in any German hospital (full survey of the German population).

Brief summary: Pancreatic surgery is complicated and risky, especially for pancreatic cancer. It's been noticed that having these surgeries done at specialized centers can lead to better outcomes and survival rates. However, factors like patient selection and hospital conditions also play an important role. Some studies show that more surgeries done at a hospital might not always mean better results, as the type of patients and procedures can vary. To understand this better, the present study compared outcomes and patient characteristics between high-volume pancreatic centers and others.

Detailed description: The study utilized German nationwide administrative data (diagnosis-related group statistics) spanning from 2010 to 2018. Persons who underwent pancreatic resections during this period were included, with exclusions for certain criteria like underage and type of procedure. Various factors including patient demographics, diagnoses, procedures, and comorbidities were analyzed to assess in-hospital mortality rates. High-volume pancreatic centers (HVPCs) were identified as those performing at least 50 procedures annually. Statistical analyses included comparing crude and adjusted mortality rates and assessing patient characteristics between HVPCs and non-HVPCs. Models were adjusted for multiple variables, and methods like the Cochran-Armitage trend test and mixed models were employed. Additionally, the study investigated how differences in patient characteristics between HVPCs and non-HVPCs affected mortality rates.

Eligibility criteria: Inclusion Criteria:

* partial or total pancreatic resections between 2010 and 2018

Exclusion Criteria:

* childhood (\<18 years)
* subjects with a pancreatic transplantation procedure
* missing information on age or gender

Primary outcomes:
measure: In-hospital mortality
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Head of Surgery at University Hospital Brandenburg an der Havel
name: Rene Mantke, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00153491: Adherence to Lumefantrine-Artemether
Official title: Assessment of Adherence to a 6-Dose Regimen of Coartem for Treatment of Uncomplicated Malaria in Children Under 5 Years in Tanzania
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malaria, Uncomplicated
Keywords: malaria
artemether-lumefantrine
co-artem
Tanzania
adherence
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: Ifakara Health Research and Development Centre
First posted: 2005-09-12
Enrollment: 300
Sex: ALL
Minimum age (years): 0
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: This is a study of how well caregivers of children with malaria adhere to the recommended regimen for lumefantrine-artemether (LA). Children were randomly assigned to either a group receiving directly observed treatment in hospital or to a group treated at home by the routine caregiver (typically, patient's mother). Clinical/parasitologic, hematologic, pharmacologic and qualitative parameters were monitored over a 28-day follow-up period and are used to evaluate drug adherence.


Eligibility criteria: Inclusion criteria:

* age \< 5 years of age.
* axillary temperature \>= 37.5oC
* unmixed infection with P. falciparum of between 1,000 and 250,000 asexual parasites/mm3 as determined by microscopic examination of thick, or thick and thin peripheral blood smears.
* parent/guardian's informed consent and willingness to participate in the study

Exclusion criteria:

* any evidence of severe or complicated malaria that would require hospitalization for treatment.
* reported allergy to any antimalarial drugs, including artemisinin derivatives and sulfa drugs.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mkuranga
country: Tanzania
facility: Mkuranga District Hospital
state: Mkuranga District
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Louise Causer, MBBS, MScPH
role: STUDY_DIRECTOR
affiliation: Ifakara Health Research and Development Centre
name: Salim Abdulla, MD, PhD
role: STUDY_DIRECTOR
affiliation: Centers for Disease Control and Prevention
name: Peter B Bloland, DVM, MPVM
role: PRINCIPAL_INVESTIGATOR
affiliation: Centers for Disease Control and Prevention
name: Stephen P Kachur, MD, MPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT03905291: Pharmacokinetic/Pharmacodynamic Characteristics and Safety/Tolerability of MT921 in Healthy Subjects
Official title: A Randomized, Double-blinded, Placebo-controlled, Single Center, Dose Escalation, Phase I Study to Evaluate the Pharmacokinetic/Pharmacodynamic Characteristics and Safety/Tolerability of MT921 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2019-04-05
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the pharmacokinetic/pharmacodynamic characteristics and safety/tolerability of MT921 in Healthy Subjects


Eligibility criteria: Inclusion Criteria:

* Adults aged between 20 and 65 years

Exclusion Criteria:

* Subject not appropriate for participating in this study according to the investigator's opinion

Primary outcomes:
measure: Maximum Concentration (Cmax) measured by Liquid Chromatography-mass spectrometry (LC/MS)
timeFrame: Up to 24 hours
measure: AUC0-24
timeFrame: Up to 24 hours
measure: Maximum Time (Tmax) measured by Liquid Chromatography-mass spectrometry (LC/MS)
timeFrame: Up to 24 hours
measure: Half-life (t1/2) measured by Liquid Chromatography-mass spectrometry (LC/MS)
timeFrame: Up to 24 hours
Secondary outcomes:
Other outcomes:
measure: Number of participants with adverse events as assessed by MedDRA version 17.0
timeFrame: Up to 21 days
Locations:
city: Seoul
country: Korea, Republic of
facility: Anam Hospital
Study officials:
References:
Clinical trial NCT04218591: A Study on the Effect of Platelet Rich Plasma (PRP) on Osteoarthritis in the Thumb Base
Official title: A Study on the Effect of Platelet Rich Plasma (PRP) on Osteoarthritis in the Thumb Base
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thumb Osteoarthritis
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2020-01-06
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized comparison between Platelet Rich Plasma (PRP) and placebo (Saline) for thumb base.osteoarthritis.


Eligibility criteria: Inclusion Criteria:

* Arthritis in the thumb base.
* Radiological Eaton Littler class 1-3.
* Clinical signs of thumb base osteoarthritis: pain at palpation of the CMC-1 joint and pain during provocation/grinding test.

Exclusion Criteria:

* Rheumatoid arthritis.
* Ongoing infection in the hand or wrist.
* History of gout or pseudo gout.
* Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction).
* Intra-articular injection in the affected joint within 6 months.
* Eaton Littler class 4 (STT joint involved).

Primary outcomes:
measure: Change in patient-rated pain on load
timeFrame: 3 and 6 months after injection.
Secondary outcomes:
measure: Change in Nelson Thumb score
timeFrame: 3 and 6 months after injection.
measure: Change in EQ-5D
timeFrame: 3 and 6 months after injection.
measure: Change in Patient-rated Wrist and Hand Evaluation (PRWHE)
timeFrame: 3 and 6 months after injection.
measure: Change in Disability of the Hand, Arm and Shoulder (DASH) score
timeFrame: 3 and 6 months after injection.
measure: Change in Hospital Anxiety and Depression Score (HADS),
timeFrame: 3 and 6 months after injection.
measure: Change in Pain Catastrophizing Score (PCS).
timeFrame: 3 and 6 months after injection.
measure: Change in thumb range of motion
timeFrame: 3 and 6 months after injection.
measure: Change in thumb strength
timeFrame: 3 and 6 months after injection.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Hand Surgery Södersjukhuset
Study officials:
affiliation: Karolinska Institutet
name: Maria Wilcke, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04676191: Validation of a Contactless Vital Signs Measurement Sensor
Official title: Single- Center Performance Assessment of a Contactless Sensor for Vital Physiological Parameters Measurement at Rest and Detection of Diagnostic Indices in Sleep Compared to Cardiorespiratory Polygraphy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea
Keywords: respiration
sleep
Lead sponsor: Sleepiz AG
Sponsor class: INDUSTRY
First posted: 2020-12-19
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary aim of this study is to validate the performance of Sleepiz One+ for the measurement of vital physiological parameters in adult population, against a laboratory-based polysomnography. Additionally, the investigators will evaluate Sleepiz One+ ability to identify patients with a high risk of suffering from a sleep-related breathing disorder based on apnea-hypopnea index estimation. Participants will undergo measurement with Sleepiz One+ and a polysomnography device while resting in bed for 20 min as well as during sleep for the duration of the following night.


Eligibility criteria: Inclusion Criteria:

* Age \>18years
* Ability and consent to undergo electrophysiological routine assessment
* Informed Consent as documented by signature
* Patients diagnosed or suspected to suffer from sleep apnea or any other sleep related disorder or patients suffering from chronic cardiac, respiratory or neuromuscular disorders
* Ambulatory or stationary patients of Klinik Lengg

Exclusion Criteria:

* Previous enrolment into the current study,
* Enrolment of the investigator, his/her family members, employees and other dependent persons
* Cardiac pacemaker or another implanted electrical device
* Women who are pregnant
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, delirium etc. of the participant

Primary outcomes:
measure: Respiration rate measurement accuracy agreement
timeFrame: 60 seconds
Secondary outcomes:
measure: Binary classification of sleep apnea severity based on the AHI > 15 of Sleepiz One+ compared to results of Domino software and data manually scored by sleep technician
timeFrame: 1 Night
measure: Instantaneous respiration rate agreement between Sleepiz One+ and nasal cannula
timeFrame: 60 seconds
measure: Average respiration rate agreement between Sleepiz One+ and thoracic respiratory effort belt
timeFrame: 1 Night
measure: Average respiration rate agreement between Sleepiz One+ and nasal cannula
timeFrame: 1 Night
measure: Sleep/wake classification agreement between Sleepiz One+ compared to polysomnography (PSG) data manually scored by sleep technician
timeFrame: 60 seconds
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Klinik Lengg AG
Study officials:
affiliation: Klinik Lengg, Zurich
name: Bartosz Bujan, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03212391: WAVE Study- Walking and Aging in VErona Study
Official title: Effect of Diet and Physical Exercise, With or Without Nordic Walking, on Weight Loss, Physical Performance and Cardiovascular Risk Factors in Elderly Overweight and Obese Subjects.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Abdominal Obesity
Metabolic Syndrome
Disability Physical
Sarcopenic Obesity
Hypertension
Overweight and Obesity
Cardiovascular Risk Factor
Lead sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Sponsor class: OTHER
Collaborators: name: Universita di Verona
First posted: 2017-07-11
Enrollment: 64
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Monocentric unblinded two parallel-group randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Monocentric unblinded two parallel-group randomized controlled trial to evaluate the effect of diet with or without Nordic Walking on weight loss, physical performance and cardiovascular risk factors in overweight and obese population

Detailed description: To examine the impact of a 48-week of diet +/- Nordic Walking program on physical performance, muscle function, cardiovascular risk factors and arterial stiffness in community-dwelling overweight and obese elderly men and women.

Eligibility criteria: Inclusion Criteria:

* 60-90 years

  * Males and females

    . BMI \> 27 kg/m2
  * living in Verona (Italy)
  * stable weight in the 3 months
  * not involved in physical exercise programs
  * informed consent sign

Exclusion Criteria:

* cardiovascular disease (unstable angina, recent myocardial infarction, cardiac arrhythmias, heart failure, valvular heart disease, aortic aneurysm, recent intracerebral or subdural hemorrhage, not controlled hypertension)
* musculoskeletal disease (symptomatic discal hernia, symptomatic arthrosis, acute articular, tendon or ligament lesions, hip prothesis).

Primary outcomes:
measure: VO2 max
timeFrame: 12 months
Secondary outcomes:
measure: VO2 max changes
timeFrame: 3, 6, 9 and 12 months
measure: PWV
timeFrame: 3, 6, 9 and 12 months
measure: muscle strength
timeFrame: 3, 6, 9 and 12 months
measure: fat mass
timeFrame: 3, 6, 9 and 12 months
measure: muscle mass
timeFrame: 3, 6, 9 and 12 months
measure: SF 36
timeFrame: 6 and 12 months
measure: GDS
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Verona
country: Italy
facility: AOUI Verona
Study officials:
affiliation: AOUI Verona
name: Mauro Zamboni
role: STUDY_DIRECTOR
References:
citation: Muollo V, Rossi AP, Milanese C, Zamboni M, Rosa R, Schena F, Pellegrini B. Prolonged unsupervised Nordic walking and walking exercise following six months of supervision in adults with overweight and obesity: A randomised clinical trial. Nutr Metab Cardiovasc Dis. 2021 Apr 9;31(4):1247-1256. doi: 10.1016/j.numecd.2020.12.012. Epub 2020 Dec 17.