louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00998361: Hematopoietic Stem Cell Transplantation From Human Leukocyte Antigen (HLA) Compatible Donor in Ewing Sarcomas and Soft Tissues Sarcomas
Official title: Hematopoietic Stem Cell Transplantation From HLA Compatible Donor in Ewing Sarcomas and Soft Tissues Sarcomas
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ewing
Soft Tissue Sarcoma
Keywords: Sarcoma
allogeneic
Hemopoietic stem cell transplant
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
Collaborators: name: S. Anna Hospital
First posted: 2009-10-20
Enrollment: 140
Sex: ALL
Minimum age (years): 1
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a perspective multicentric study for the treatment of patients aged equal or less than 60 years and submitted to an allogeneic hematopoietic stem cell transplantation from an HLA compatible related or unrelated donor because affected by resistent or refractory or relapsed after autologous stem cell transplantation Ewing Sarcoma or Soft tissues sarcoma who did not benefit from conventional therapy.


Eligibility criteria: Inclusion Criteria:

* Age 0-60 years.
* Performance status according to Karnofsky score \> 70%
* Normal liver function
* Normal renal function
* Normal cardiac function
* Informed consent
* Availability of an HLA compatible Donor

Exclusion Criteria:

* Absence of at least one of the inclusion criteria

Primary outcomes:
measure: Progression Free Survival (PFS) a 12 months from the enrollment higher than 30% for the patients submitted to allogeneic stem cell transplantation in front of the patients who received conventional chemotherapy.
timeFrame: 12 months from the enrollement
Secondary outcomes:
measure: Transplant related mortality
timeFrame: 12 months after the enrollement of the first patients
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Pediatric Oncology and Hematology Department, S. Orsola-Malpighi Hospital
Study officials:
affiliation: S. Orsola-Malpighi Hospital
name: Arcangelo Prete, MD, PhD, PI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00890461: Reconstruction of 12-Lead Electrogram From Intracardiac Signals From Defibrillators During or After Implantation
Official title: Reconstruction of 12-Lead Electrogram From Intracardiac Signals From Defibrillators During or After Implantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ICD
Keywords: ECG
ICD
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2009-04-29
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects will be identified by their cardiologist who is also an investigator on this study at the time they are evaluated for an ICD implantation. Once it has been determined during the course of the patient's regular clinical care that he or she requires an ICD, they will be approached for enrollment into the study by the physician investigator and the clinical research coordinator.

Brief summary: The purpose of this study is to reconstruct a 12-lead electrocardiogram (ECG) from intracardiac (IC) electrograms (EGM) obtained from defibrillator devices (ICD). The purpose of such a reconstruction is to allow the use of IC EGM for diagnosis of clinical conditions for which ECG have historically been used, and to test the feasibility of a reconstruction technique for the standard 12-lead or extended electrocardiogram from electrical potentials obtained from inside a patient.

Detailed description: Reconstructing a 12-lead surface ECG from intracardiac EGM vectors of patients implanted with defibrillators can be of great value. It allows implantable devices that have thus far been used exclusively for arrhythmia detection and treatment, to be used for diagnostic purposes in similar ways as the ECG. The advantage of the reconstruction process is that it provides real-time continuous monitoring, which can be used for multiple purposes, including but not limited to:

1. Ischemia detection
2. Myocardial Infarction detection
3. Electrolyte abnormalities detection
4. Assessment of effect of medications
5. Improved rhythm discrimination

Eligibility criteria: Inclusion Criteria:

1. Subjects must be at least 18 years of age.
2. Subjects must be referred for ICD implantation or already have an ICD implanted..
3. Subjects must be willing to sign informed consent.

Exclusion Criteria:

1. Subject is unable or unwilling to sign informed consent.
2. Subject is pacemaker dependent.
3. Subject is pregnant as indicated by standard clinical procedures prior to implant.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Presbyterian
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Shadyside
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Samir F Saba, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05943561: Biomarkers in Concussion
Official title: Biomarkers in Concussion
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Concussion, Mild
Concussion, Intermediate
Concussion, Severe
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 100
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Athletes with or without concussion.

Brief summary: This will be an observational study measuring serum Neurofilament Light Chain concentrations and associated symptoms, with a control branch, and a post-concussion branch.


Eligibility criteria: Inclusion Criteria:

Over 12 years of age Athletes participating on a sports team willing to participate; undergo blood draws either weekly or every two weeks, depending on arm of study.

Exclusion criteria:

Existing active neurodegenerative disorder (ie severe TBI) Active peripheral nerve disorder (ie diabetic neuropathy)

Primary outcomes:
measure: Normalization of NfL levels
timeFrame: 12 weeks
Secondary outcomes:
measure: Resolution of concussion symptoms
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Medstar Health Research Institute
name: Nicholas Streicher
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02133261: BDx 7 Day ECG Patch: Electrode Adhesion Clinical Study
Official title: BDx 7 Day ECG Patch: Electrode Adhesion Clinical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Patients
ECG Monitoring
Lead sponsor: Bardy Diagnostics, Inc.
Sponsor class: INDUSTRY
First posted: 2014-05-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cardiac patients followed at the study site's location

Brief summary: The purpose of this research study is to learn if a new 7 day patch ECG recording monitor can serve the same purpose as standard monitoring systems. The new 7day patch is significantly smaller and lighter than previous ECG recorders.

Detailed description: The primary purpose of this research is to evaluate ECG signal quality of the BDx 7 day ECG Patch heart monitor after 7 full days of wear, establishing that the device is safe and effective to wear for up to 7 days.

Eligibility criteria: Inclusion Criteria:

* cardiac patient volunteers (5 male and 5 female)

Exclusion Criteria:

* skin rash or infection over the sternum
* Sternal incision within 3 months from the date of enrollment

Primary outcomes:
measure: adhesive performance/durability
timeFrame: 7 days
Secondary outcomes:
measure: human factors
timeFrame: 7 days
Other outcomes:
Locations:
city: Enumclaw
country: United States
facility: EvergreenHealth
state: Washington
Study officials:
affiliation: EvergreenHealth
name: Gene Trobaugh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06944561: Improved Diagnostics for Paediatric Tuberculosis
Official title: Improved Diagnostics for Paediatric Tuberculosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
Keywords: paediatric
Tuberculosis
Lead sponsor: St George's, University of London
Sponsor class: OTHER
First posted: 2025-04-25
Enrollment: 16
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Improved diagnostics for paediatric Tuberculosis

Detailed description: Research Question: To test the feasibility of TiKa system to reliably detect Mycobacterium tuberculosis in faeces of paediatric patients with Tuberculosis Study Design: Non-randomised diagnostic proof of concept feasibility study Study Participants: Patients with or suspected to have Tuberculosis

Eligibility criteria: Inclusion Criteria:

* Any patient under the age of 21 years with the following diagnosis for whom informed consent can be obtained will be offered to be included in the trial.

  * Latent tuberculosis
  * Culture confirmed Tuberculosis
  * Clinically suspected Tuberculosis

Exclusion Criteria:

* Any patient over 21
* Any child or adult/guardian unable to give informed consent
* Any persons under detention will not be included.
* Any patient who is unable to give a sample.

Primary outcomes:
measure: To quantitate the speed of new culture method (TiKa) and compare its efficacy with conventional systems in detecting Mycobacterium tuberculosis in the faeces of paediatric patients with tuberculosis.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: CIU Office, St George's NHS Healthcare Trust
Study officials:
References:
Clinical trial NCT06913361: Effects of Gongs Mobilization vs Reverse Distraction Technique in Diabetic Patients With Adhesive Capsulitis
Official title: Effects of Gongs Mobilization vs Reverse Distraction Technique in Diabetic Patients With Adhesive Capsulitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Adhesive Capsulitis
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Adhesive capsulitis (AC) represents a renowned musculoskeletal condition which has been clinically classified as frozen shoulder (FS). Adhesive capsulitis occurs 3-5% of the time in the general population, but in diabetics, the frequency can reach 20%. This study is being conducted to determine the effects of gongs mobilization vs reverse distraction technique in diabetic patients with adhesive capsulitis. This study will be a randomized control trial and data will be collected from Haq Orthopedic Hospital. Sample size is 20 calculated by using G power and adding 20 % attrition.

Detailed description: Non-Probability convenient sampling will be used. Participants meeting the inclusion and exclusion criteria will be divided into two groups.10 subjects in group A will be treated Gongs mobilization and group B will be treated with Reverse distraction technique. Conventional therapy will be given to both groups as base line treatment. Both groups have 4 sessions per week for 4 weeks. All participants will be evaluated before and after the treatment using Numeric Pain Rating scale (NPRS), Shoulder pain and Disability Index (SPADI) and goniometer.

Eligibility criteria: Inclusion Criteria:

* Both males and females.
* Diagnosed case of Unilateral Adhesive Capsulitis.
* Age group of 40-60 years.
* Stage 2 and 3 of Adhesive Capsulitis.
* Diabetes Mellitus Type II.
* Patients with decreased ROM (less than or equal to 120 degrees), pain, and mild to moderate levels of type II diabetics (below or equal to 200 mg/dL).
* No history of shoulder surgeries to the affected shoulder.

Exclusion Criteria:

* Systemic arthritic conditions of the shoulder (Rheumatoid arthritis, osteoporosis or malignancies in the shoulder region) .
* Disorders of the Cervical spine .
* Corticosteroids injections in the affected Shoulder in preceding 6 weeks.
* Skin lesions or bruises around the Shoulder.
* Shoulder injuries such as Rotator cuff tear.
* Fracture in and around the shoulder joint.

Primary outcomes:
measure: NUMERIC PAIN RATING SCALE (NPRS)
timeFrame: 12 Months
measure: SHOULDER PAIN AND DISABILITY INDEX
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Haq Orthopaedic hospital, Sanda road
state: Punjab
Study officials:
References:
Clinical trial NCT01819961: Parenteral Fish Oil in Major Laparoscopic Abdominal Surgery
Official title: Randomized Clinical Trial of Omega-3 Fatty Acid-supplemented Parenteral Nutrition Versus Standard Parenteral Nutrition in Patients Undergoing Major Laparoscopic Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Gastric Tumor
Pancreatic Tumor
Liver Tumor
Lead sponsor: Sir Run Run Shaw Hospital
Sponsor class: OTHER
First posted: 2013-03-28
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess the effect of postoperative parenteral fish oil on clinical outcome and immune function after major laparoscopic abdominal surgery.

Detailed description: Postoperative patients are randomized by a sealed envelope to receive either a 50:50 (vol/vol) mixture of an oil rich in medium-chain fatty acids and soybean oil (termed MCT/LCT) or a mixture of MCT/LCT and fish oil Omegaven for 7 days. Full blood count, biochemistry and coagulation are routinely assessed. Fresh blood samples are centrifuged into plasma, red blood cells and lymphocytes then stored at -80°C pending analysis.

The primary endpoint was numbers of infective complications.Secondary endpoints were other clinical outcomes, length of hospital stay, and in-hospital mortality, along with plasma immunological markers.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing an elective major laparoscopic abdominal surgery and required at least 5 days of parenteral nutrition

Exclusion Criteria:

* Metabolic disease
* Chronic kidney or liver failure
* Shock
* Contraindications for lipid administration
* PN during the 15 days before hospitalisation

Primary outcomes:
measure: infective complications
timeFrame: within the first 30 days after surgery
Secondary outcomes:
measure: length of hospital stay
timeFrame: average of 2 weeks
measure: plasma immunological markers
timeFrame: from 1 day before surgery to 7 days after surgery
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hosptial
state: Zhejiang
Study officials:
affiliation: Sir Run Run Shaw Hospital
name: Yiping Mou, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00532961: Ocular Tolerance and Intraocular Pressure (IOP) Effects of Zylet Versus Tobradex
Official title: A Randomized, Double-masked, Parallel Comparison of Ocular Tolerance and IOP Effects of Zylet vs TobraDex Administered Four Times Daily for Four Weeks in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Inflammation
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2007-09-21
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase IV, randomized, double-masked, parallel-group clinical trial comparing the ocular tolerability and steroid-induced intraocular pressure (IOP) effects of Zylet wth that of TobraDex in healthy volunteers, when either product was administered QID (at approximately 4-hour intervals) for 28 days.


Eligibility criteria: Inclusion Criteria:

* in good general health based on investigator judgment
* able and willing to follow instructions, provide informed consent, make the required study visits, and use an electronic patient diary during the study
* possessing a best corrected visual acuity of at least 20/40 in each eye
* for females, using reliable contraception and a negative urine pregnancy test prior to study entry

Exclusion Criteria:

* contact lenses worn within 30 days prior to enrollment or during study period
* known hypersensitivity to study medication or any component
* presence of significant ocular or systemic disease that might interfere with the interpretation of the results
* a need for administration of chronic topical ocular or systemic medications of any kind during the study.
* participation in an opthalmic drug or device research study within 30 days prior to entry

Primary outcomes:
measure: Ocular comfort/tolerability
timeFrame: Day 1, 3, 8, 15, 22 and 29
measure: Intraocular pressure measurements
timeFrame: Day 1, 3, 8,15, 22 and 29
Secondary outcomes:
measure: Assessment of safety
timeFrame: Througout 28-day study
Other outcomes:
Locations:
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Timothy L Comstock, DO
role: STUDY_DIRECTOR
References:
citation: Bartlett JD, Holland EJ, Usner DW, Paterno MR, Comstock TL. Tolerability of loteprednol/tobramycin versus dexamethasone/tobramycin in healthy volunteers: results of a 4-week, randomized, double-masked, parallel-group study. Curr Med Res Opin. 2008 Aug;24(8):2219-27. doi: 10.1185/03007990802231981. Epub 2008 Jun 23.
Clinical trial NCT04614961: Database Concerning Patients Consulting the Obesity Clinic
Official title: Database Concerning Patients Consulting the Obesity Clinic of University Hospitals Leuven
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Overweight and Obesity
Bariatric Surgery
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 999999
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with overweight, obesity or after bariatric surgery

Brief summary: A registry of individuals that visit the Obesity Clinic of the University Hospitals of Leuven will be established. The objective of this registry is to improve the knowledge about obesity, the treatment of obesity and its outcomes.

Detailed description: A registry/database is constructed with data of the individuals that visit the Obesity Clinic of the University Hospitals of Leuven. Data will be obtained from the screening visits and all follow-up visits in terms of sociodemographics, treatment and treatment outcomes, disease impact, biochemistry, questionnaires, QoL, ...

Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Age 18 years or older
* Subjects with overweight, obesity or after bariatric surgery

Primary outcomes:
measure: Routine treatment data (sociodemographics, treatment and treatment outcome, disease impact, biochemistry, questionnaires, ...)
timeFrame: up to 100 years
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Obesity Clinic University Hospitals Leuven
Study officials:
References:
Clinical trial NCT01864083: FACBC PET and PEM as a Staging Tool and Indicator of Therapeutic Response in Breast Cancer Patients
Official title: FACBC PET and PEM as a Staging Tool and Indicator of Therapeutic Response in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Keywords: FACBC PET/PEM
MR
11-177
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2013-05-29
Enrollment: 30
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study has been designed to help us determine if FACBC PET or PEM can accurately evaluate how far the breast cancer has spread in the breast. Also, to help determine if FACBC PET or PEM can accurately measure your response to chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Women presenting for evaluation at MSKCC with biopsy proven primary IDC or ILC
* No prior therapy for IDC or ILC
* Clinical need for local disease staging with breast MR (Group A only)
* Clinical need for neoadjuvant chemotherapy (Group B only)
* Patients must provide written informed consent

Exclusion Criteria:

* Age \<21 years
* Men
* Pregnancy or lactation
* Patients who have already started treatment for the current malignancy
* Patients who cannot undergo PET scanning (i.e. because of weight limits)
* Patients who are known to have contraindication for MRI (e.g. metal implants)
* Patients may only participate in group #1 or group #2, but not both

Primary outcomes:
measure: assess the diagnostic accuracy
timeFrame: 2 years
measure: ability of FACBC PET and PEM to determine therapeutic response to neoadjuvant chemotherapy
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Gary Ulaner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ulaner GA, Goldman DA, Corben A, Lyashchenko SK, Gonen M, Lewis JS, Dickler M. Prospective Clinical Trial of 18F-Fluciclovine PET/CT for Determining the Response to Neoadjuvant Therapy in Invasive Ductal and Invasive Lobular Breast Cancers. J Nucl Med. 2017 Jul;58(7):1037-1042. doi: 10.2967/jnumed.116.183335. Epub 2016 Nov 17.