louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02389595: Selection of a Protective T Cell-based HIV-1/FIV Vaccine
Official title: Selection of a Protective T Cell-based HIV-1/FIV Vaccine Devoid of Viral Enhancing Epitopes
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: HIV
Keywords: HIV
vaccine
T cell
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2015-03-17
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV positive individuals between 18 and 65 years old

Brief summary: The purpose of this research study is to develop a vaccine against Human immunodeficiency virus (HIV), a disease that causes AIDS in people,. The investigator will be looking at viruses similar to HIV in animals. Since these viruses are very similar to HIV, the blood from humans who have been exposed to HIV will be tested to see if the immune system will recognize the HIV and prevent infection.

HIV targets the immune system by attacking certain T cells called CD4+ T cells. There are parts on the AIDS viruses that help the virus infect these cells and other parts that help the immune system prevent viral infection by activating protective T-cells that fight HIV. Different T-cell populations are very important in most vaccines as they act as "effectors" that work as part of the immune system to recognize and fight off HIV infection. When effector T cells are activated by appropriate "protective" part(s) of the virus they either block HIV from reproducing or kill HIV infected cells. By finding these common protective parts of each of these human and animal AIDS viruses, the investigator hopes to make a vaccine that helps the immune system prevent HIV infection by avoiding parts that attack CD4+ T cells and may worsen HIV infection and selecting for parts that stimulate effector T cells that fight HIV infection.

Detailed description: As a participant in this study a blood drawn will performed.

Eligibility criteria: Inclusion Criteria:

* Male and female subjects between 18 and 65 years old who are HIV positive

Exclusion Criteria:

* Persons with other immune diseases that would result in autoimmunity or aberrant immune responses (such as subjects who have undergone chemotherapy within the past year).

Primary outcomes:
measure: T cell proliferation in response to viral epitopes
timeFrame: 120 hours (5 days)
Secondary outcomes:
measure: Cytokine production in response to viral epitopes
timeFrame: 24 hours (1 day)
measure: Cytotoxin production in response to viral epitopes
timeFrame: 8 hours
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: UF Center for AIDS Research Education and Service
state: Florida
Study officials:
affiliation: University of Florida
name: Janet K Yamamoto, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02501395: MRI in Patients With Kennedy Disease
Official title: MRI in Patients With Kennedy Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bulbo-Spinal Atrophy, X-Linked
Kennedy Disease
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2015-07-17
Enrollment: 53
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons in Denmark diagnosed with Kennedy disease is invited to the study.

Gender and age matched controls will be recruited to a control group.

Brief summary: Kennedy disease is an inherited neuromuscular disorder that is characterized by progressive muscle wasting and weakness. It typically starts with muscle spasms and tremors in the arms, followed by muscle weakness and atrophy of muscles in the arms and legs. The facial and bulbar muscles are also involved. However, the muscle involvement pattern has not been investigated systemically in Kennedy disease.

The primary aim of the study is to investigate the muscle involvement in patients with Kennedy disease using MRI. Secondary aims are to examine disease severity and to test MRI as a potential outcome measure for future clinical trials in Kennedy disease.

Approximately 40 patients with Kennedy disease and 20 gender and age matched healthy voluntary controls will be recruited. The study consists of one visit per subject lasting 4-5 hours.


Eligibility criteria: Patients with Kennedy disease:

Inclusion Criteria:

* Confirmed Kennedy disease

Exclusion Criteria:

* All contraindications for undergoing an MRI scan

Healthy controls

Inclusion Criteria:

* Fit age and gender criteria

Exclusion Criteria:

* All contraindications for undergoing an MRI scan

Primary outcomes:
measure: Muscle fat fraction
timeFrame: One MRI scan per subject (exam lasts approximately 60 min.)
Secondary outcomes:
measure: Muscle strength
timeFrame: One muscle strength test per subject (exam lasts approximately 60 min.)
measure: Minimal dataset for data collection in Kennedy disease
timeFrame: Data will be collected once for patients with Kennedy disease (exam lasts approximately 90 min.)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen Neuromuscular Center
Study officials:
affiliation: Copenhagen Neuromuscular Center, Department of Neurology, Rigshospitalet, Copenhagen University
name: Julia R Dahlqvist, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06758895: Cardiac Magnetic Resonance Predictors of Outcome of Rhythm Control in Patients with Atrial Fibrillation/Flutter
Official title: Cardiac Magnetic Resonance Predictors of Outcome of Rhythm Control in Patients with Atrial Fibrillation/Flutter
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Rhythm Monitoring
Keywords: CMR predictors of rhythm control in patient with AFibirilation/flutter
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 90
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: Based on the previously reported antiarrhythmic drug efficacy of 52% in maintaining sinus rhythm:

* For Wilcoxon-Mann-Whitney test for difference in 2 group means: assuming an alpha error probability of 0.05, a study power of 60-70%, and a 1:1 ratio of successful rhythm control vs atrial fibrillation/flutter recurrence, a total sample size of 86-106 would be needed (43-53 for each arm). \[calculated by G\*Power software v.3.1.9.7\]
* To be able to build multivariable logistic regression models including, e.g., 4-5 predictor variables, a reasonable sample size would be 80-100 patients.
* Patient enrollment will continue until the projected sample size is satisfied or until 24 months have lapsed, whichever comes first.

Brief summary: evaluate the impact of various features in CMR on the mid-term/long-term success rate of rhythm control for paroxysmal atrial fibrillation/flutter .

Detailed description: * Atrial fibrillation/flutter are widely prevalent.
* Reported antiarrhythmic drug efficacy to restore \& maintain sinus rhythm is 52% which is far from optimal.
* On the other hand, 5-year arrhythmia-free survival after catheter ablation was previously reported to be 63%.
* Therefore, there is a need for better characterization of the underlying atrial substrate, to improve treatment outcomes in terms of efficacy and safety

Eligibility criteria: Inclusion Criteria:

* Age\>18 years.
* Patients undergoing successful cardioversion (pharmacologic or electric) for atrial fibrillation/flutter, OR symptomatic patients with paroxysmal atrial fibrillation/flutter scheduled for trans-catheter ablation.
* Index cardioversion OR Index ablation procedure.

Exclusion Criteria:

* LA thrombus on TEE or CMR.
* Contraindications to CMR.
* Contraindications to Gd-based contrast.

Primary outcomes:
measure: Recurence in patient with AF or flutter after pharmacological or interventional rythm control
timeFrame: Baseline
Secondary outcomes:
measure: parameters for safe ablation
timeFrame: Baseline
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut Univeristy Heart Hospital
Study officials:
affiliation: Assiut University
name: Salah EL-dein Sayed Ata, Professor of cardiology
role: STUDY_DIRECTOR
References:
citation: 1. Calkins H et al. Circ Arrhythm Electrophysiol. 2009
Clinical trial NCT02979795: Translational Research in Identifying Molecular Mechanisms for Rectal Cancer Metastasis
Official title: Translational Research in Identifying Molecular Mechanisms for Rectal Cancer Metastasis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rectal Cancer
Chemoradiation
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2016-12-02
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Rectal cancer patients in China Medical University Hospital (Age: 20 yrs and older)

Brief summary: Rectal cancer, comprised of 30% of overall colorectal cancer cohort, is one of the leading cancers of Taiwan. In patients with advanced disease, the standard of care is concurrent chemoradiotherapy (CCRT) before surgery. After CCRT, the abscopal effect, a phenomenon that localized radiation not only destroys local tumor but also inhibits the growth of tumor at the remote site, has been observed. This effect is believed to be associated with tumor immune response. In addition, other immune checkpoint molecules, such as Programmed cell death-1(PD-1), Programmed cell death ligand-1 (PD-L1), and Cytotoxic T-Lymphocyte Associated Protein 4 (CTLA-4), have been reported associated with therapeutic outcome. However, after CCRT, more than 50% of patients were still either having persistent disease or developed distant metastasis. To improve therapeutic outcome of patients with rectal cancer, this project, thus, aims at exploring the evolution of factors that may affect the abscopal effect and immune checkpoint functions in tissues and in blood before and after CCRT.

Detailed description: For most patients, preoperative chemoradiotherapy results in clinically tumor regression, but the degree of response varies among patients. There are approximately 40-60% of LARC patients treated with CCRT achieve some degree of pathologic response. However, there is yet an effective method before the commencement of CCRT that can predict how patients will respond to CCRT and can subsequently render better survival. Identify patents who will benefit most from CCRT is crucial not only in lowering treatment-related morbidity and sustaining local control but also to improve survival rate in LARC.

Eligibility criteria: Inclusion Criteria:

* Rectal cancer patients in China Medical University Hospital (Age limit: 20 yrs and older)

Exclusion Criteria:

* Pregnancy, Disabilities

Primary outcomes:
measure: Tumor regression rate
timeFrame: within 8 weeks after completion of chemoradiotherapy
Secondary outcomes:
measure: Disease free survival
timeFrame: 5 year
measure: Overall survival
timeFrame: 5 year
measure: Local recurrence
timeFrame: 5 year
measure: Distant metastasis
timeFrame: 5 year
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University Hospital
name: Kan Sun Clifford Chao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06437795: Effectiveness of Dry Needling Versus Cupping Therapy for Pain in Piriformis Syndrome
Official title: Effectiveness of Dry Needling Versus Cupping Therapy for Pain in Piriformis Syndrome
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Piriformis Syndrome
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-05-31
Enrollment: 80
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: DIAGNOSTIC

Brief summary: This study aims to compare the effectiveness of two popular therapeutic interventions, dry needling and cupping therapy, in alleviating pain associated with Piriformis Syndrome. Piriformis Syndrome is a neuromuscular disorder caused by the compression or irritation of the sciatic nerve by the piriformis muscle, leading to buttock pain and radiating numbness.

Detailed description: The study will recruit participants diagnosed with Piriformis Syndrome and will randomly assign them to receive either dry needling or cupping therapy over a specific period. The primary outcome will be the reduction in pain intensity measured by standardized pain assessment tools. Secondary outcomes will include improvements in functional mobility and quality of life. By analyzing the efficacy and patient-reported outcomes of both therapies, the study aims to provide evidence-based recommendations for clinicians treating Piriformis Syndrome.

Eligibility criteria: Inclusion Criteria:

* Adults aged between 18 to 65 years.
* Diagnosed with piriformis syndrome.
* Experiencing chronic pain for at least 3 months.
* Willingness to comply with the study protocol and attend all therapy sessions.

Exclusion Criteria:

* Recent surgery on the lower back or hip.
* Presence of systemic diseases affecting muscle function (e.g., multiple sclerosis, rheumatoid arthritis).
* Pregnant or breastfeeding women.
* Use of anticoagulant medication or having a bleeding disorder.
* Participating in another clinical trial simultaneously

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 12 Months
measure: Oswestry Disability Index (ODI)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Ghurkee Hospital
state: Punjab
Study officials:
References:
Clinical trial NCT00696995: An Observational Study of Type 2 Diabetes in Patients Starting on NovoMix® 30 Treatment
Official title: An Observational, Prospective Safety Study in Subjects With Type 2 Diabetes Mellitus Starting NovoMix® 30 (Biphasic Insulin Aspart) Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-06-13
Enrollment: 509
Sex: ALL
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with type 2 diabetes.

Brief summary: This study is conducted in Europe. The aim of this observational study is to evaluate the incidence of serious adverse drug reactions when initiating or switching to insulin therapy with NovoMix® 30 in subjects with type 2 diabetes under normal clinical practice conditions


Eligibility criteria: Inclusion Criteria:

* Patients with Type 2 diabetes
* Insulin-naive or previously treated by basal only insulin therapy

Exclusion Criteria:

* Patients who are unlikely to comply with the protocol
* Pregnancy or breastfeeding or intention of becoming pregnant

Primary outcomes:
measure: The number of serious adverse drug reactions, including major hypoglycaemic events
timeFrame: at 26 weeks
Secondary outcomes:
measure: The number of all hypoglycaemic events
timeFrame: at 26 weeks
measure: HbA1c
timeFrame: at 12 weeks and 26 weeks
measure: Fasting plasma glucose at visits
timeFrame: at 12 weeks and 26 weeks
Other outcomes:
Locations:
city: Lahti
country: Finland
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Makela JK, Schmuser C, Askonen K, Saukkonen T. Starting or switching to biphasic insulin aspart 30 (BIAsp 30) in type 2 diabetes: a multicenter, observational, primary care study conducted in Finland. Diabetes Res Clin Pract. 2012 Jan;95(1):10-8. doi: 10.1016/j.diabres.2011.06.006. Epub 2011 Nov 9.
Clinical trial NCT03433495: Adaptation of Melodic Intonation Therapy to Spanish
Official title: Adaptation of Melodic Intonation Therapy to Spanish: a Feasibility and Validation Pilot Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Stroke Aphasia
Keywords: stroke
aphasia
melodic intonation therapy
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2018-02-14
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study was conducted in three phases:

The first phase involved creation of a Spanish adaptation of the Melodic Intonation therapy; the second phase consisted of a pilot non-randomized intervention study to analyse its feasibility for use with 4 Spanish patients with poststroke nonfluent aphasia; the third phase consisted of a pilot randomised, crossover, intervention pilot trial in a different set of patients with poststroke nonfluent aphasia (N=20)


Eligibility criteria: Inclusion Criteria:

Patients diagnosed with nonfluent aphasia due to unilateral stroke in the left hemisphere without neuroimaging evidence of lesions in the right hemisphere who fulfilled the following criteria:

* The time elapsed since the stroke exceeded 6 months.
* Patient had received a standard program of conventional speech therapy after stroke.
* Persistent nonfluent aphasia with the following characteristics:

  * Severely restricted language, which might be limited to meaningless stereotypy; unlike that observed in verbal tasks, the patient might produce some real and relevant words when singing familiar songs.
  * Poor repetition, even for single words.
  * Moderately preserved language comprehension.
  * The nonstereotyped language was produced with a slurring of speech.
  * The total score for the repetition did not exceed the 70th percentile in the Boston Diagnostic Aphasia Examination. The score was obtained from the average score in three areas: repetition of words and repetition of phrases; listening comprehension exceeding the 15th percentile of Boston Diagnostic Aphasia Examination; and from the average score obtained in three areas: word comprehension, commands and complex ideational material.
* The patient was motivated, emotionally stable and had good attention.
* Signed informed consent was provided.

Exclusion Criteria:

* patients with a history of a previous stroke other than the index event or with any clinical condition (e.g., short life expectancy, coexisting disease) or other characteristics that precluded appropriate follow-up in the study
* patients participating in any therapeutic intervention clinical trials evaluating poststroke recovery
* use of psychotropic drugs that interfere with patient evaluation.

Primary outcomes:
measure: Communicative Activity Log questionnaire
timeFrame: 6 weeks after the end of therapy
measure: Boston Diagnostic Aphasia Examination
timeFrame: 6 weeks after the end of therapy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02801695: Evaluation of the Efficacy of Citrulline Supplementation on the Delay of Delivery for Women Hospitalized for Pre-eclampsia (CITRUPE)
Official title: Evaluation of the Efficacy of Citrulline Supplementation on the Delay of Delivery for Women Hospitalized for Pre-eclampsia (CITRUPE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pre-eclampsia
Pregnancy
Keywords: pre-eclampsia
citrulline
pregnancy
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2016-06-16
Enrollment: 116
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pre-eclampsia (PE) complicates 2-8 % of pregnancies and is associated with high maternal and fetal morbidity and mortality. The early clinical manifestations are the occurrence of a maternal blood pressure and proteinuria. Placental dysfunction impairs the nutrient supply to the fetus, and may be the cause of an intrauterine growth retardation (IUGR). This is a disease that causes prematurity and currently the only known cure is delivery of the placenta. Nitrogen monoxide (NO) regulates the placental blood flow. However, pre-eclampsia is directly related to a failure of placental NO production. In this context, several clinical trials have tested the effect of NO donors such as L- arginine. However, supplementation with L -Arginine in a randomized trial in Nantes, has proved to be ineffective in severe vascular IUGR.

Citrulline is a natural aminoacid precursor to arginine and in contrast to L-arginine escapes uptake in the liver and appears directly in the peripheral blood converted by the kidney in arginine, released into the systemic circulation, Citrulline may therefore be more effective in the treatment of pre-eclampsia.

This prospective, randomized, comparative and double-blinded study aims to prolong pregnancy for patients with pre-eclampsia before 36 weeks.


Eligibility criteria: Inclusion Criteria:

* age \>= 18 years old
* pregnant woman
* singleton pregnancy
* woman with pre-eclampsia (\<36 weeks) without indication of forthcoming extraction
* subjects affiliated with an appropriate social security system
* subjects out of context of guardianship
* written signed informed consent form

Exclusion Criteria:

* age \< 18 years old
* isolated hypertension or isolated proteinuria
* severe pre-eclampsia with indication of forthcoming extraction in emergency
* term pregnancy \>= 36 Weeks when diagnosis is done
* multiple pregnancy
* lactose intolerance
* context of guardianship

Primary outcomes:
measure: number of days between the therapeutic initiation and childbirth
timeFrame: childbirth
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: Hôpital Cochin (Maternité Port-Royal)
Study officials:
affiliation: Nantes University Hospital
name: Nobert Winer, Dr
role: PRINCIPAL_INVESTIGATOR
References: