louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02813642: Evaluation of Cardiovascular Risk Factors in Incident Dialysis Patients
Official title: Evaluation of Non Traditional Cardiovascular Risk Factors in Chronic Kidney Disease Patients Starting Dialysis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: chronic kidney disease starting dialysis
cardiovascular risk
bone mineral metabolism markers
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-06-27
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To evaluate the relationships between bone mineral markers levels at dialysis start and vascular calcification progression during a 2 year follow up


Eligibility criteria: Inclusion Criteria:

* Patient who has signed the written consent form
* Patient with chronic renal failure starting dialysis therapy

Exclusion Criteria:

* Pregnancy
* Patient with chronic renal failure not yet on dialysis therapy

Primary outcomes:
measure: Progression of vascular calcifications during a 2 year follow up according to plasma osteoprotegerin level at inclusion
timeFrame: 2 years after inclusion
Secondary outcomes:
measure: Progression of vascular calcifications during a 2 year follow up according to plasma fibroblast growth factor 23 level at inclusion
timeFrame: 2 years after inclusion
measure: Occurence of cardiovascular events during a 2 year follow up
timeFrame: 2 years after inclusion
Other outcomes:
Locations:
city: Castelnau Le Lez
country: France
facility: Centre Hémodialyse du Lez
city: Montpellier
country: France
facility: AIDER
city: Montpellier
country: France
facility: CHU Montpellier, Nephrology department
city: Nimes
country: France
facility: CH Nimes, Nephrology department
city: Perpignan
country: France
facility: CH Perpignan, Nephrology department
Study officials:
affiliation: CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE
name: Jean-Paul Cristol, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00437242: Odiparcil QT Definitive Study
Official title: A Study to Evaluate the Effect of Repeat Oral Doses of Odiparcil on Cardiac Conduction as Assessed by 12-lead Electrocardiogram Compared to Placebo and a Single Oral Dose of Moxifloxacin.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Fibrillation, Atrial
Atrial Fibrillation
Keywords: interval,
atrial fibrillation
QT,
odiparcil,
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-02-19
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is being completed to demonstrate the lack of effect of repeat dosing with Odiparcil on the QTc interval.


Eligibility criteria: Inclusion:

* Healthy volunteers

Exclusion:

* Cardiac abnormalities
* Hepatic or renal insufficiency
* Anti-coagulant medications
* Bleeding history

Primary outcomes:
measure: demonstrate lack of effect of repeat dose on QT interval with ECG measured on Days -1, 5 and 6 at 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 16, 18, 20 and 24 hours
Secondary outcomes:
measure: Pharmacokinetics, CMAX, AUC, TMAX, PK samples taken at 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 16, 18, 20 and 24 hours on days 5 and 6
Other outcomes:
Locations:
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05459142: Telemedicine Medical Abortion Service Using the "No-test" Protocol in Azerbaijan.
Official title: Safety and Acceptability of Telemedicine Medical Abortion Service Using the "No-test" Protocol in Azerbaijan.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Related
Keywords: Telemedicine
Pregnancy
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: Scientific Research Institute of Obstetrics and Gynecology
First posted: 2022-07-14
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who seek early first-trimester abortion at the participating study site and would like to receive telemedicine medical abortion services.

Brief summary: The goal of this study is to pilot and evaluate a telemedicine medical abortion service delivery that allows remote communication between the woman and provider and limits medically unnecessary in-person visits to health or diagnostic centers.

Detailed description: The goal of this study is to pilot and evaluate a telemedicine medical abortion (TMA) service delivery that allows remote communication between the woman and provider and limits medically unnecessary in-person visits to health or diagnostic centers. Providers will provide counseling by phone or video about pregnancy options and give detailed information about the medical abortion process, expected side effects, and where to seek additional care. The provider will then evaluate the woman's eligibility for TMA service by following the no-test protocol and discuss at-home follow-up using a symptom checklist and a high-sensitivity urine pregnancy test. If pre-treatment tests are needed, women will be referred to a nearby diagnostic center and test results will be forwarded to the study provider. Participants will receive medications by mail or courier service or pick them up at the pharmacy or study clinics, take medications as instructed, and complete at-home follow-ups as discussed with the provider.

Eligibility criteria: Inclusion Criteria:

* Is pregnant as determined by a pregnancy test or ultrasound (if obtained prior to contacting the study site)
* Has no contraindications to medical abortion
* Has access to a phone
* Is able to take mifepristone on or before 63 days of gestation

Exclusion Criteria:

* Medically ineligible for medical abortion
* Gestational age above 63 days based on LMP

Primary outcomes:
measure: The incidence rate of adverse events resulting from the remote provision of medical abortion
timeFrame: 6 weeks
Secondary outcomes:
measure: Satisfaction with remote provision of medical abortion
timeFrame: 6-weeks
Other outcomes:
Locations:
city: Baku
country: Azerbaijan
facility: Scientific-Research Institute of Obstetrics and Gynecology
Study officials:
References:
Clinical trial NCT05015842: Effectiveness of Kinesio Tapping for the Treatment of Patients With Acute Low Back Pain: A Randomized Control Trial
Official title: Effectiveness of Kinesio Tapping for the Treatment of Patients With Acute Low Back Pain: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Low back pain, Kinesio tapping, conventional physical therapy, Oswestry disability index
Lead sponsor: NCS University System
Sponsor class: OTHER
First posted: 2021-08-20
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study was to determine the effectiveness of Kinesio Taping (KT) for the treatment of patients with acute low back pain.

In this study a total of 56 patients with acute low back pain were randomly allocated to the experimental group, KT along with conventional Physical therapy (PT), or the control group, conventional PT alone.

Detailed description: The objective of the study was to determine the effectiveness of Kinesio Taping (KT) for the treatment of patients with acute low back pain.

In this study a total of 56 patients with acute low back pain were randomly allocated to the experimental group, KT along with conventional Physical therapy (PT), or the control group, conventional PT alone. 28 Patients received KT in addition to conventional PT while 28 patients received conventional PT alone for two weeks. Oswestry disability index (ODI) and numeric pain rating scale (NPRS) were used for the measurement of outcomes.

Eligibility criteria: Inclusion Criteria:

* Both Genders
* Age between 18 and 60 years
* History of LBP less than

Exclusion Criteria:

* Patients having diagnosed conditions of spondylolisthesis, spondylosis, lumbar stenosis, spinal tumor, lumber fracture, renal disease and trauma were excluded from the study.
* Patients either with chronic LBP (duration more than 3 months) or contraindicated to KT (skin allergy or pre-existing skin lesion or infection) were also excluded.
* Female Pregnant patients were also excluded from the study.

Primary outcomes:
measure: Pain intensity
timeFrame: 2 weeks
Secondary outcomes:
measure: Functional Disability
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: NCS University System, Department of Physical Therapy and Rehabilitation
state: Khyber Pakhtunkhwa
Study officials:
affiliation: Khyber Medical University
name: Dr. Haider Darain, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04549142: Immune Tolerance Dysfunction in Pregnancy Due to Ambient Air Pollution Exposure
Official title: Immune Tolerance Dysfunction in Pregnancy Due to Ambient Air Pollution
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Air Pollution
Pregnancy
Keywords: immune function
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Environmental Health Sciences (NIEHS)
name: Duke University
First posted: 2020-09-16
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women at 18-25 weeks gestation and non-pregnant women

Brief summary: The purpose of this project is to study the effects of air pollution toxicants on pregnant mothers' immune health during and after pregnancy.

Using already collected samples, this study proposes to evaluate changes in immune function in response to air pollution with the use of innovative technologies, to identify the drivers of immune dysfunction and potential modifiable factors, and to determine how these immune findings are associated with pollution exposure and outcomes of disease.


Eligibility criteria: Inclusion Criteria:

* Pregnant women: at 18-25 weeks gestation at time of eligibility screening and baseline visit

Exclusion Criteria:

* Having smoked more than 50 cigarettes during pregnancy
* A history of autoimmune diseases, HIV or cancer

Primary outcomes:
measure: Difference in immune cell subset identity and function in pregnant vs. non pregnant women exposed to high vs. low pollution over time
timeFrame: 3 years
measure: Identify the epigenetic molecular mechanisms driving immune dysfunction in pregnancy vs. no pregnancy with high vs. low PM2.5 exposure over time
timeFrame: 3 years
measure: Map T cell receptor diversity to immune dysfunction in pregnancy vs non pregnancy with high vs. low PM2.5 exposure over time
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Sean N. Parker Center for Allergy & Asthma Research at Stanford University
state: California
Study officials:
affiliation: Stanford, Sean N Parker Center for Allergy and Asthma Center at Stanford
name: R. Sharon Chinthrajah, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04111042: Long-term Outcomes of Colonic Stent as a "Bridge to Surgery" for Malignant Large-bowel Obstruction
Official title: Long-term Outcomes of Colonic Stent as a "Bridge to Surgery" for Malignant Large-bowel Obstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stent Occlusion
Long-term Oncologic Results
Keywords: Malignant colonic obstruction
self-expandable metallic stent
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
Collaborators: name: Xavier Serra-Aracil
name: Anna Pallisera-Lloveras
First posted: 2019-10-01
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: : patient demographics, physiological status according to the American Society of Anesthesiologist (ASA) score, tumor characteristics and localization, type of surgery, surgical team, stoma formation rate, perioperative morbidity and mortality, tumor stage according to the International Union Against Cancer (UICC)-TNM Classification of Malignant Tumors published by the National Comprehensive Cancer Network (7th edition), administration of adjuvant treatment, local and distant disease recurrence based on CT imaging (and histological tissue if possible), disease-free survival and overall survival.

Brief summary: Study of long-term outcomes of colonic stent as a "bridge to surgery" for malignant large-bowel obstruction.

Detailed description: Prospective observational with retrospective analisis study of patients with left-sided malignant colonic obstruction undergoing stenting between April 2006 and April 2018 in Parc Tauli University Hospital. We assessed all patients with intent-to-treat and per protocol analyses in postoperative and long-term follow-up variables.

Eligibility criteria: Inclusion Criteria:

* Patients aged over 18 years diagnosed with complete malignant colonic obstruction confirmed by CT.
* Elective surgery.
* Location in transverse, left or sigmoid colon.
* Patients who signed the informed consent documentation and agreed to undergo the procedure.

Exclusion Criteria:

* Benign pathology and palliative treatment.
* Unresectable lesion (intraoperative), severe ischemia or cecal perforation, fecal or advanced purulent peritonitis, emergency surgery.
* Previous chemotherapy.

Primary outcomes:
measure: long-term outcomes
timeFrame: 2 years
Secondary outcomes:
measure: anastomotic leak
timeFrame: 30 days
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Laura Mora López
state: Barcelona
Study officials:
References:
Clinical trial NCT01857570: Volume CT of the Wrist and Carpus After Trauma
Official title: Volume CT of the Wrist and Carpus After Trauma: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wounds and Injuries
Wrist Injuries
Keywords: Radius fracture
Scaphoid fracture
Tomography, x-ray computed
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2013-05-20
Enrollment: 100
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: All consecutive patients who enter the emergency or radiology department of the Radboud University Nijmegen Medical Centre for suspicion on fractures of the wrist and study are eligible for this study.

Brief summary: The purpose of this study is to evaluate whether standard volume computed tomography (CT) has impact on treatment in patients with suspicion of fractures of the wrist and carpus.


Eligibility criteria: Inclusion Criteria:

* Patients (18 years and older) who are referred to our hospital for conventional radiography of the wrist and carpus
* Recent trauma mechanism (within 3 days before presentation)
* Clinical suspicion of fractures of the wrist and carpus. The carpus includes all carpal bones, but does not include the metacarpal bones.

Exclusion Criteria:

* Patients who were not evaluated by a clinician before imaging was performed.
* Open fractures
* No informed consent or no prospective data collection could be obtained. Informed consent cannot be obtained in case patients do not speak or understand Dutch.
* Patients who cannot be positioned in upright position, immobilized on a spine board or transferred to the intensive care unit and cannot undergo upright CT

Primary outcomes:
measure: Proportion of patients with prospectively documented treatment changes after CT
timeFrame: within same visit (i.e. in one day)
Secondary outcomes:
measure: Diagnostic performance of CT and conventional radiography (CR) for fracture pattern
timeFrame: within the same visit (one day)
Other outcomes:
measure: Radiological feasibility
timeFrame: Within an average of three days after CT
measure: Patient outcome: Pain and disability
timeFrame: one year
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
Study officials:
affiliation: Radboud University Medical Center
name: Mathias Prokop, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center
name: Monique Brink, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02874170: Study of the Function and Muscle Metabolism in Drepanocytose Affected Patient During a Moderate Intensity Exercise
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Drepanocytose
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-08-22
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Drepanocytose disease is the first genetic disease in the world. It results in the synthesis of an abnormal hemoglobin (HbS), which in its deoxygenated form, polymerizes and leads to structural changes of red blood cells (RBC) which then take the shape of a sickle, become more fragile, more rigid and less deformable. The fragility of GR sickle causes their mass destruction, leading to chronic anemia (i.e. low levels of GR in the blood) associated with low tissue oxygenation. More rigid and less deformable, sickle GR tend to hang in the microvessels, leading to vaso-occlusive crises (CVO) particularly painful, can cause the failure of certain organs (spleen, kidneys, brain, lung, heart, liver , bone ...) and to life-threatening patients. Preliminary studies conducted on patients with drepanocytose disease (HbSS) have demonstrated changes of muscle tissue indicating a possible failure in the supply and use of oxygen. To date, the translation of this metabolic remodeling in the muscle work is not known.

This project's main objective is to evaluate muscle function in drepanocytose attempted patients. We hypothesized that muscle remodeling associated with sickle cell disease have a functional impact on strength and muscle metabolism. The main objective is to characterize the maximal voluntary plantar flexor muscles. The criteria for these targets will be based on the comparison between healthy subjects, carriers of the sickle cell trait (HbAS) and sickle cell patients (HbSS) oxygen saturation.

The strictly non-invasive approach proposed in this project will study the functional parameters of the muscle of sickle cell disease and the possible link with the clinical manifestations of the disease, including vaso-occlusive crisis, in which tissue oxygenation and pH plays a major role.


Eligibility criteria: Inclusion Criteria:

* Patient affected by sickel cells and healthy volonteers presenting no contre indication to spectrometry exam.

Exclusion Criteria:

* Patient affected by hemoglobinopathies other than drepanocytose

Primary outcomes:
measure: Percentage of phosphorus 31released during muscle exercise assesses by magnetic resonance spectroscopy
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Urielle DESALBRES
role: STUDY_DIRECTOR
affiliation: Assistance Publique Hôpitaux de Marseille
name: Jean-Pierre MATTEI, Md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02025270: MSCs For Treatment of Azoospermic Patients
Official title: Using of Bone Marrow Derived Mesenchymal Stem Cells For Treatment of Azoospermic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Male Infertility
Keywords: Azoospermia, Spermatogonial Arrest, Maturation Arrest.
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2014-01-01
Enrollment: 100
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study, we performed autologous BMDMSC transplantation to the testis of Azoospermic patients in a trial to enhance and activate the spermatogonial stem cells of the testis and aiming to produce motile sperm.

Detailed description: Bone marrow aspirated and stem cells were isolated, cultured and characterized using flow cytometer. Stem cells prepared according to GMP regulations then injected into rete testis using special syringe. Patients follow up will carried out for a year , three month interval. FSH, testosterone, testicular size as well as sexual potency will assessed every three months.

Eligibility criteria: Inclusion Criteria:

* All Non obstructive Azoospermic Patients.
* Azoospermic Patients due to Administration of Chemo/Radiotherapy.

Exclusion Criteria:

* Patients with Testicular Cancer.
* Patients with Complete Deletion of Chromosome Y AZF (a,b,c) Regions.

Primary outcomes:
measure: All Cases Improvement
timeFrame: One Year (12-Month)
Secondary outcomes:
measure: All Cases Fertility Improvement
timeFrame: One Year (12-Month)
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al Azhar University , School of Medicine
Study officials:
affiliation: Al-Azhar University
name: Taimour M Khalifa, MD Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Al-Azhar University
name: Sayed Bakry, PhD
role: STUDY_DIRECTOR
affiliation: Al-Azhar University
name: Saad Moneer, MSc
role: STUDY_CHAIR
affiliation: Al-Azhar University
name: Ahmed Kadeh, MSc
role: STUDY_CHAIR
References: