louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05536180: Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the PTCA NC Catheters Family
Official title: Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the PTCA NC Catheters Family
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Stenosis
Lead sponsor: Arthesys
Sponsor class: INDUSTRY
First posted: 2022-09-10
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing PTCA procedure

Brief summary: The purpose of this post market study is to collect clinical data of the Arthesys PTCA NC catheters family during angioplasty intervention of coronary vessels or coronary bypass graft stenosis to support MDR submission.


Eligibility criteria: Inclusion Criteria:

Patients will be included as per Instructions for Use (IFU), Hospital standard of care and Good Clinical Practice (GCP):

* Patient with a Percutaneous intervention to a native coronary or coronary bypass graft indication
* Patient \>18 years
* Patient who understands the trial requirements and the treatment procedures and provides written informed consent

Exclusion Criteria:

Patients will be excluded as per IFU, Hospital standard of care and GCP. Patients will not be included if they are under judicial protection, guardianship or curatorship or if they are deprived of their liberty by judicial or administrative decision.

Primary outcomes:
measure: Efficacy endpoint
timeFrame: up to end of procedure
measure: Safety endpoint
timeFrame: up to end of procedure
Secondary outcomes:
measure: Performance - Pre-dilatation
timeFrame: up to end of procedure
measure: Performance - post-dilatation
timeFrame: up to end of procedure
Other outcomes:
Locations:
city: La Rochelle
country: France
facility: Hopital Saint Louis
Study officials:
References:
Clinical trial NCT05241080: Stress Among Final Year BAMS Students in Relation With Covid Lockdown Through CSSQ-a Cross Sectional Survey
Official title: Covid -19 Related Stress Among Final Year BAMS Students During Lock Down Days in Kerala-A Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid Related Psychological Stress
Keywords: Stress,covid,lock down days
Lead sponsor: Amrita Vishwa Vidyapeetham
Sponsor class: OTHER
Collaborators: name: Amrita Viswa Vidyapeetham
First posted: 2022-02-15
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All final year students Of BAMS studying inside Kerala.

Brief summary: We were randomly selected the ayurveda colleges in Kerala.Selected final year BAMS students as participants.we have also selected a group of 5 members for data colle tion.we have selected a validated Covid stress questionnaire and circulated through what's app and Gmail.we were received responses from each college with .we analyzed and interpreted data.

Detailed description: We were randomly selected the ayurveda colleges in Kerala.Selected final year BAMS students as participants.we have also selected a group of 5 members for data colle tion.we have selected a validated Covid stress questionnaire and circulated through what's app and Gmail.we were received responses from each college with .we analyzed and interpreted data.

Eligibility criteria: Inclusion Criteria 1.final year BAMS 2.irrespective of gender

-

Exclusion Criteria:

* age group other than 20-22 yrs

Primary outcomes:
measure: Likert scale
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kollam
country: India
facility: Dr Preeti
state: Kerala
Study officials:
affiliation: Amrita Viswa Vidyapeetham
name: Dr.preethi Mohan, BAMS MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Amrita Vishwa Vidyapeetham
name: Delvin T Robin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02457780: Stress Management Program for World Trade Center (WTC) Responders
Official title: Mind-Body Treatment for WTC Responders With Comorbid PTSD and Respiratory Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Signs and Symptoms, Respiratory
Keywords: PTSD
Trauma
World Trade Center
Respiratory
Mind-Body
Lead sponsor: Stony Brook University
Sponsor class: OTHER
Collaborators: name: National Institute for Occupational Safety and Health (NIOSH/CDC)
First posted: 2015-05-29
Enrollment: 157
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: Many responders to the World Trade Center (WTC) disaster continue to experience significant mental and physical health problems. Two of the most common health problems, post-traumatic stress disorder (PTSD) symptoms and respiratory illness, often occur together. Mental health conditions, such as PTSD, make physical illnesses worse and interfere with treatment. The primary goal of this study is to test a mind-body treatment designed to reduce both PTSD and respiratory symptoms.

Detailed description: Mind-body interventions including relaxation training and other coping skills are effective for patients with both mental and physical health problems. A leading mind-body treatment is the Relaxation Response Resiliency Program (3RP) developed at Harvard. This treatment has been shown to reduce both mental and physical health symptoms.

The objective of this study is to adapt the 3RP to WTC responders and test its ability to reduce both PTSD and respiratory symptoms. This treatment will be compared to a Health Enhancement Program that addresses negative health behaviors. The investigators will randomly assign 175 patients with ongoing WTC-related PTSD and respiratory illness to the 3RP or Health Enhancement Program and will assess outcomes immediately after the treatment and at 3 and 6 month follow-ups.

Eligibility criteria: Inclusion Criteria:

* PCL score equal to or greater than 35
* 2 or more lower respiratory symptoms

Exclusion Criteria:

* Regular elicitation of the relaxation response
* History of psychosis
* Current unmanaged bipolar disorder
* History of suicide attempt --OR-- current ideation with plan or intent

Primary outcomes:
measure: Self-report WTC-related PTSD Symptoms
timeFrame: Change from baseline in WTC-related PTSD symptoms at 6-months
measure: Clinician Rated WTC-related PTSD Symptoms
timeFrame: Change from baseline in WTC-related PTSD symptoms at 6-months
Secondary outcomes:
measure: Lower Respiratory Symptoms
timeFrame: Change from baseline in lower respiratory symptoms at 6-months
measure: Pulmonary Functioning
timeFrame: Change from baseline in pulmonary functioning at 6-months
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University, Putnam Hall
state: New York
Study officials:
affiliation: Stony Brook University Department of Psychiatry
name: Adam Gonzalez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00572780: Can CT Enteroclysis Predict the Outcome of Crohn's Disease
Official title: Can CT Enteroclysis Predict the Response to Therapy and Outcome in Patient With Crohn's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Keywords: Crohn's Disease
CT Enteroclysis
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2007-12-13
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Crohn's disease patients that have had a CT Enteroclysis as part of their clinical evaluation for symptomatic Crohn's disease will be eligible. Subjects who were later diagnosied with bowel malignancy and subjects with a period of follow-up of less than 1 year(without surgery) will be excluded.

Brief summary: Specific CT Enteroclysis findings with or without other clinical and laboratory variables, can identify Crohn's disease patients who will response to medical therapy versus those who will either fail and require surgery or have uncontrolled disease.


Eligibility criteria: Inclusion Criteria:

* Crohn's disease with CT Enteroclysis during symptomatic treatment

Exclusion Criteria:

* Crohn's disease subjects who have had a follow-up less than 1 year, without surgery
* Crohn's disease subjects that were later diagnosed with a bowel malignancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Michael V. Chiorean, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06704880: CONSTRAINT-INDUCED MOVEMENT THERAPY VERSUS CROSS EDUCATION IN CHILDREN WITH CEREBRAL PALSY
Official title: Lower Limb Constraint-induced Movement Training Versus Strength Training of the Non-hemiplegic Lower Limb on Motor Performance in Children With Hemiplegic Cerebral Palsy: A Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hemiplegic Cerebral Palsy
Lead sponsor: Imam Abdulrahman Bin Faisal University
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial aims to Compare the effectiveness of lower limb CIMT and the Strength Training of the Non-Hemiplegic lower limb on motor performance in hemiplegic children with CP.

Participants will:

diagnosed with hemiplegic cerebral palsy treated with CIMT or Strength training (cross-education) for a non-hemiplegic limb for 8 weeks.

3 sessions per week. Measurements will be taken at baseline and then at the end of the 8 weeks.

Detailed description: Method:

32 children with hemiplegic CP will be equally and randomly allocated to two groups (group A and B). group A will receive lower limb CIMT for the non- hemiplegic limb using whole leg orthosis and Group B will receive strengthen training for the non-hemiplegic lower limb. Both groups will receive routine physical therapy for the hemiplegic lower limb. Both groups will receive 60 minutes training session for 3 sessions per week for 8 consecutive weeks. Assessment will be at baseline then at the end of trial.

Eligibility criteria: Inclusion Criteria:

1. Children with hemiplegic cerebral palsy aged age between 4 and 10.
2. (GMFCS) levels I, II and III.
3. Able to follow therapist instructions during training session.

Exclusion Criteria:

1. Lack of patient's cooperation.
2. Difficulty wearing constraint method due to severe joint deformation or/and contracture.
3. Patients were treated with botulinum toxin during the last 3 months.
4. Seizure disorder not fully controlled by medication.

Primary outcomes:
measure: gait speed
timeFrame: at base line then at the end of the 8 weeks
measure: cadence gait spatiotemporal parameter
timeFrame: at base line then at the end of the 8 weeks
measure: step length
timeFrame: at base line then at the end of the 8 weeks
measure: stride length
timeFrame: at base line then at the end of the 8 weeks
Secondary outcomes:
measure: Pediatric balance scale
timeFrame: at base line then at the end of the 8 weeks
measure: 6 Minute walk test (6MWT)
timeFrame: at base line then at the end of the 8 weeks
measure: Modified Ashworth scale
timeFrame: at base line then at the end of the 8 weeks
measure: Handheld dynamometer
timeFrame: at base line then at the end of the 8 weeks
Other outcomes:
Locations:
city: Dammam
country: Saudi Arabia
facility: Imam Abdulrahmn Alfaisal University
Study officials:
References:
Clinical trial NCT06552780: High Intensity Laser Versus Ischemic Compression on Myofascial Trigger Points in the Upper Trapezius
Official title: High Intensity Laser Versus Ischemic Compression on Myofascial Trigger Points in the Upper Trapezius
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Neck Pain
Keywords: "myofascial pain syndrome" "trigger points" "high intensity laser " "ischemic compression"
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-08-14
Enrollment: 63
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Treatment
Primary purpose: TREATMENT

Brief summary: TO Investigate the effect of high intensity laser versus ischemic compression on myofascial trigger points on neck pain, cervical range of motion,pressure pain thershold and cervical disability and to show that the more effectivness therapy will provide significant clinical value

Detailed description: Randomized controlled Trial , participants will be assigned into three groups (study group A ,study group B and study group c ) Subject selection will be 63 subjects , 21 subjects in each group with trigger points in the upper trapezius.

Groups

Eligibility criteria: Inclusion Criteria:

* The age of patients range from 20 to 50 years .
* patient Body mass index starting from 19 to 25 kg\\m.
* presence of myofascial trigger points in the shortened upper trapezius muscle evaluated .

Exclusion Criteria:

* patients with fibromyalgia syndrome.
* cancer or tumor or any type diagnosed .
* patients with disc herniation or spinal canal stenosis.
* pregnancy -
* patients diagnosed with epilepsy.

Primary outcomes:
measure: cervical range of motion (CROM)
timeFrame: 30 seconds
Secondary outcomes:
measure: cervical pain
timeFrame: one minute
Other outcomes:
measure: pressure pain threshold (PPT)
timeFrame: 10 seconds
Locations:
city: Giza
country: Egypt
facility: Faculty of physical therapy
Study officials:
affiliation: RAGIAA M KAMEL , PROF DR
name: RAGIAA KAMEL, PROFFESOR DR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05806580: Secondary Infusion of Relma-cel Injection for Relapsed or Refractory B-cell Lymphoma
Official title: A Single-arm Prospective Study of Secondary Infusion of Relmacabtagene Autoleucel Injection for Relapsed or Refractory B-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Relapsed or Refractory B-cell Lymphoma
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2023-04-10
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To observe the efficacy and safety of a second infusion of relma-cel injection in patients with relapsed or refractory B-cell lymphoma.

Detailed description: This study aims to collect efficacy and safety data from adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) who receive a second infusion of relma-cel injection after initial treatment with relma-cel. The study will not include any form of grouping, and subgroup analysis will be conducted based on the actual data collected.

Eligibility criteria: Inclusion Criteria:

* Patients have signed an Informed Consent Form (ICF).
* Adults diagnosed with relapsed or refractory B-cell lymphoma who have completed initial treatment with Relma-cel.
* Patients must have undergone at least one disease assessment post-initial Relma-cel treatment, and the investigator decides to administer a second treatment (including PR/PD/SD) based on clinical practice.
* Before the second infusion, confirm that the prepared dose of relma-cel is sufficient (recommended 80-150 x 10\^6 CAR-T cells), with specific dosage determined by the investigator based on patient condition and dose availability.
* Confirm the presence of CD19+ residual tumor tissue, if clinically permissible.
* Measure plasma for the absence of anti-drug antibodies (ADA) to relma-cel before the second treatment.
* Toxicity related to lymphodepleting chemotherapy (fludarabine and cyclophosphamide), except for hair loss, must have resolved to ≤ Grade 1 or returned to baseline levels before retreatment.
* Patients must not have experienced severe adverse reactions during the first treatment, or any adverse reactions must have resolved to baseline levels from the first treatment.

Exclusion Criteria:

* Patients with hypersensitivity to active ingredients or any excipients (e.g., dimethyl sulfoxide, compound electrolyte injection, human albumin).
* Patients with uncontrolled systemic fungal, bacterial, viral, or other infections

Primary outcomes:
measure: Objective Response Rate
timeFrame: 3 months post CAR-T infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: NO.197， Ruijin Er Road
state: Shanghai
Study officials:
References:
Clinical trial NCT05638880: Clinical Study to Evaluate the Possible Efficacy and Safety of Levocetirizine in Patients With Diabetic Kidney Disease
Official title: Clinical Study to Evaluate the Possible Efficacy and Safety of Levocetirizine in Patients With Diabetic Kidney Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Diabetic Nephropathies
Lead sponsor: Tanta University
Sponsor class: OTHER
Collaborators: name: Tanta University
First posted: 2022-12-06
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The prevalence of diabetes mellitus is increasing worldwide, and its complications are one of the leading causes of mortality from non-communicable diseases. Due to the high prevalence of diabetes and because 30-40% of diabetic patients \[both type 1 (T1DM) and type 2 (T2DM) diabetes mellitus\] develop kidney dysfunction, diabetic nephropathy (DN) is the main cause of end-stage renal disease worldwide. The renin-angiotensin-aldosterone system (RAAS), endothelin, and urotensin II are vasoactive hormones that have been extensively studied as other mediators although their relation to diabetic nephropathy is still speculative.


Eligibility criteria: Inclusion Criteria:

* Age between 40 and 65.
* Both genders will be included.
* Type II diabetes mellitus confirmed by Glycosylated Hemoglobin A₁C.
* Diagnosis of diabetic nephropathy, which will be defined as persistent albuminuria with urinary albumin creatinine ratio (UACR) range \[30-300 mg /gm\], confirmed on at least two occasions 3-6 months apart, with or without decline in glomerular filtration rate at screening and receiving angiotensin receptor blockers (ARBs) and sodium-glucose cotransporter 2 (SGLT2) inhibitors therapy.
* Hemoglobin A₁C ranges from 6.5% to 10% with regular use of insulin and or/oral hypoglycemic drugs.

Exclusion Criteria:

* Other types of diabetes mellitus
* Uncontrolled hypertension (Blood pressure ≥ 180/110).
* Urinary tract infection.
* Severe anemia (Hemoglobin ˂10).
* Critically ill patient.
* Past operation, past history of trauma, heavy exercise.
* Severe renal failure (e GFR ˂ 30ml/min/1.73 m2).
* Systemic inflammatory and autoimmune diseases.
* Malignancy.
* Pregnancy and lactating women.
* Other causes of chronic kidney disease.

Primary outcomes:
measure: Reduction of albuminuria
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
Study officials:
References:
Clinical trial NCT06542380: TAVI PACER: A Two-step Risk Score for Prediction of Permanent Pacemaker Implantation After TAVI.
Official title: TAVI PACER: A Two-step Risk Score for Prediction of Permanent Pacemaker Implantation After TAVI.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pacemaker
TAVI
Risk Score
Keywords: Transcatheter aortic valve replacement
Aortic stenosis
Pacemaker implantation
Risk Score
Electrocardiogram
Risk Stratification
Lead sponsor: German Heart Institute
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 1000
Sex: ALL
Minimum age (years): 51
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Given the retrospective nature of the study, all patients who had undergone TAVI at the DHZC were included, with the exception of those meeting the exclusion criteria mentioned above. Consequently, the study population is primarily comprised of individuals aged 75 years and above, with a balanced gender distribution.

Following current guidelines, every patient undergoing TAVI received an initial assessment by a multidisciplinary heart team.

Brief summary: The need for permanent pacemaker implantation (PPMI) remains one of the most frequent complications after transcatheter aortic valve implantation (TAVI). This study aimed to develop a novel, two-step risk score to predict PPMI probability after TAVI and to implement it into a user-friendly website. Our risk score addresses the gap in existing data on current prosthesis generations and provides a new and clinically motivated approach to calculating the risk for PPMI.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing TAVI at Deutsches Herzzentrum der Charité between January 2019 and December 2020

Exclusion Criteria:

* previous device implantation
* valve-in-valve procedure
* patients who had received an ALLEGRATM valve (NVT AG, Morges, Switzerland), a LOTUS EdgeTM valve (Boston, Scientific, Natick, Massachusetts), or a CENTERATM valve (Edwards Lifesciences, Irvine, California)

Primary outcomes:
measure: Pacemaker Implantation
timeFrame: 30 days after TAVI
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin-Mitte
country: Germany
facility: Deutsches Herzzentrum der Charité
state: Berlin
Study officials:
affiliation: German Heart Institute
name: Henryk Dreger, Professor
role: PRINCIPAL_INVESTIGATOR
References: