louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00407667: Transcranial Galvanic Stimulation After Stroke
Official title: Transcranial Direct Current Stimulation (tDCS) of the Lesioned or Non-lesioned Hemisphere Plus Computer-assisted Arm Trainer: a Randomized, Placebo-controlled Double-blind Multi-centre Study in Patients With Severe Arm Paresis Early After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: hemiparesis
rehabilitation
upper limb rehabilitation
arm therapy
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2006-12-05
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Transcranial galvanic stimulation (tDCS) seems to promote motor recovery after stroke by stimulating (anodal) or inhibiting (cathodal) neural circuits in the brain. In the treatment of severe arm paresis after stroke, robot-assisted arm training (AT) proved to be effective, but nevertheless only a few patients could use their affected hand functionally in daily life after robot training. Therefore the present study intends to combine both approaches, tDCS + AT, applied at the same time every day for six weeks. The study has three treatment arms, two groups will receive the tDCS, either anodal of the lesioned or cathodal of the non-lesioned hemisphere. The anodal stimulation is expected to facilitate the activity of the arm motor area of the lesioned side directly, while the cathodal stimulation of the non-lesioned hemisphere is expected to facilitate the lesioned side indirectly by decreasing inhibitory inputs. The third group will receive a sham-stimulation. All patients will work with the AT simultaneously to the tDCS, respectively sham-tDCS.


Eligibility criteria: Inclusion Criteria:

* subacute stroke
* stroke interval 3 to 8 weeks
* severe upper limb paresis
* Fugl-Meyer \< 18

Exclusion Criteria:

* history of epilepsy
* antiepileptic, neuroleptic medication
* metal implants

Primary outcomes:
measure: Fugl-Meyer Upper Limb Motor Score (0-66)
timeFrame: 45 min
Secondary outcomes:
measure: Box&Block Test
timeFrame: 5 min
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité, University Medicine Berlin, Medical Park Berlin
city: Kreischa
country: Germany
facility: Klinik Bavaria
city: Bozen
country: Italy
facility: Villa Melitta
Study officials:
affiliation: Charité -University Medicine Berlin; Medical Park Berlin
name: Stefan Hesse, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00130767: Kinetics of the Finasteride Prostate Induced Apoptosis
Official title: Kinetics of the Finasteride Prostate Induced Apoptosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Benign Prostatic Hyperplasia
Keywords: Prostate
apoptosis
finasteride kinetics
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2005-08-16
Enrollment: 90
Sex: MALE
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the mechanisms involved in the apoptosis induced by a treatment of finasteride on benign prostate hyperplasia (BPH). Five sets of patients who need a surgical procedure because of low tract urinary symptoms are randomly attributed to one of five sets of treatment: 0, 7, 14, 21 or 28 days of finasteride treatment before the day of the procedure. Prostate histological fragments are conditioned for molecular and histologic studies.


Eligibility criteria: Inclusion Criteria:

* Patients with low tract urinary symptoms needing a surgical procedure
* No previous treatment with finasteride
* No androgen deficiency; no prostate cancer suspected.

Primary outcomes:
measure: Date of the maximum apoptosis in the prostate tissues treated by finasteride
Secondary outcomes:
measure: Molecular mechanisms involved in BPH finasteride induced apoptosis
measure: Decrease in the frequency of the hemorrhagic incidents after the surgical procedure in patients with a treatment using finasteride
Other outcomes:
Locations:
city: Pierre Bénite
country: France
facility: Centre hospitalier Lyon Sud
Study officials:
affiliation: Hospices Civils de Lyon
name: Alain RUFFION, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00145067: Osteoporosis Disease Management Demonstration Project (0000-040)
Official title: Three Methods of Delivering Health Care for Secondary Prevention of Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-09-05
Enrollment: 230
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of the study is to evaluate the impact disease management interventions in treatment compliance among post-fracture and osteoporosis patients.


Eligibility criteria: Inclusion Criteria:

* Members of of the Kaiser Permanente Health Plan who have fractured a bone.

Exclusion Criteria:

* Individuals who are not members of the Kaiser Permanente Health Plan.

Primary outcomes:
measure: Treatment persistence
Secondary outcomes:
measure: Patient satisfaction and knowledge
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Waalen J, Bruning AL, Peters MJ, Blau EM. A telephone-based intervention for increasing the use of osteoporosis medication: a randomized controlled trial. Am J Manag Care. 2009 Aug 1;15(8):e60-70.
Clinical trial NCT04584567: OD-doxy-PNV-COVID-19 Old Drug " DOXY " for Prevention of New Virus " COVID-19 "
Official title: Covid-19 Infection Prophylaxis With Low Dose of Doxycycline and Zinc in Health Care Workers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Covid19
Lead sponsor: General Administration of Military Health, Tunisia
Sponsor class: NETWORK
Collaborators: name: Dacima Consulting
First posted: 2020-10-14
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants who meeting study entry criteria will be randomized in a 1:1 blinded comparison of daily low dose DOXY versus oral placebo for 6 weeks.
Primary purpose: PREVENTION

Brief summary: Given the urgency of having guidelines for the management of COVID-19 in the current epidemic context and the lack of specific pharmacological treatment, Military Health recommends the launch of a multicenter, randomized, double-blind, interventional clinical trial.

The aim of this study is to evaluate the efficacy of a combination of two treatments, low-dose doxcycline (100 mg/day) and Zinc (15 mg/day) (dietary supplement) in the primary prevention of COVID-19 infection in health care professionals in Tunisia compared to two control groups.


Eligibility criteria: Inclusion Criteria:

* No self-medication with study drugs or antivirals
* Negative COVID19 diagnosis confirmed by PCR and negative Elisa antibody assay
* No signs of COVID19
* Having given consent for the study

Exclusion Criteria:

Participation in other clinical trials aimed at primary prevention of VIDOC infection19

* Liver failure
* Known allergy to the study product
* Pregnancy or breastfeeding
* Vitamin A and E treatment in progress

Primary outcomes:
measure: decreasing the number of cases infected with covid 19
timeFrame: WEEK 6
Secondary outcomes:
measure: Measurement of the emergence of clincal symptoms of COVID 19
timeFrame: WEEK 6
measure: the seroprevalence of SARS- CoV 2 IgM/IgG positive samples at study entry and study conclusion in all participants receiving DOXY compared to those receiving placebo.
timeFrame: WEEK 6
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Military Hospital of Tunis
state: Montfleury
Study officials:
affiliation: Military hospital
name: Batikh R Riadh, physican
role: STUDY_CHAIR
affiliation: Military hospital
name: Stambouli N nejla, phd
role: STUDY_DIRECTOR
affiliation: Military hospital
name: Gharsallah H Hedi, physican
role: PRINCIPAL_INVESTIGATOR
affiliation: Direction de la Santé militaire
name: Ferjani M Mustapha, physican
role: STUDY_CHAIR
affiliation: Military hospital
name: Ben Moussa M mohamed, physican
role: STUDY_CHAIR
affiliation: Military hospital
name: Youssfi MA Mohamed Al, physican
role: STUDY_CHAIR
References:
Clinical trial NCT04808167: Remote Ischemic Conditioning in HSCT
Official title: Remote Ischemic Conditioning for Protection From Treatment-related Cardiotoxicity in Pediatric and Adolescent Patients Undergoing Hematopoietic Stem Cell Transplantation: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoietic Stem Cell Transplantations
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 17
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This is a feasibility study at a single site, Cincinnati Children's Hospital Medical Center. The hypothesis will be tested using a prospective study design. The purpose of the study is to determine tolerability and safety of remote ischemic conditioning in pediatric and adolescent patients undergoing HSCT, with the goal of a larger trial of efficacy to follow. The secondary purpose is to determine if remote ischemic conditioning will reduce subclinical cardiotoxicity as measured by markers of myocardial injury and stress in patients undergoing HSCT. The study will include multiple blood collections and echocardiograms.


Eligibility criteria: Inclusion Criteria:

1. Pediatric, adolescent, or young adult patients, 10 years of age or above.
2. Able to tolerate upper arm blood pressure inflation.
3. Participating in the BMT Biorepository (2012-1156).

Exclusion Criteria:

1. Systolic blood pressure \>160 mmHg.
2. Previous diagnosis of cardiomyopathy (dilated, hypertrophic, restrictive, myocarditis) or congenital heart disease other than bicuspid aortic valve.
3. Chronic kidney disease as defined as a pre-transplant GFR \<80
4. Central line in both upper extremities.
5. Known peripheral vascular disease or vasculitis.
6. Platelet count less than 30,000.
7. Known clotting disorder or hypercoagulability
8. Non-English speaking patients.

Primary outcomes:
measure: Adverse events
timeFrame: 18-24 months from start of enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Thomas Ryan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03753867: RA Effect on Cell Surface Molecules in Vivo
Official title: Retinoic Acid Effect on Cell Surface Molecules in Vivo
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: HIV Infections
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will follow a group of healthy male participants for about 18 weeks to see the effect of taking Acitretin on their immune cells

Detailed description: Retinoids have been shown in in vitro and ex vivo models to have the ability to reverse latency reactivating the HIV reservoir and the potential for selective eradication of HIV-harbouring cells. We feel that acitretin shows significant potential as a potential adjuvant to current ART regimens, however, there is a lack of data to demonstrate that treatment with acitretin at normal are able to induce molecular and transcription changes consistent with the above activities. In order to provide a scientific basis for retinoid therapy in HIV infection, a Phase I trial of acitretin in human subjects is proposed.

Eligibility criteria: Inclusion Criteria:

1. Male gender
2. Age 18 - 65
3. Able to provide informed consent
4. Willingness to participate in study treatment and follow-up
5. Willingness for serial phlebotomy and storage and future viro-immunological assays

Exclusion Criteria:

1. Female gender
2. Participants with a known hypersensitivity/allergy to the acitretin.
3. Participants who are actively participating in an experimental therapy study or who have received experimental therapy within the last 1 year.
4. Participants who are a poor medical risk because of other systemic diseases or active uncontrolled infections including HIV, Hepatitis B or C, and tuberculosis
5. Participants with impaired glucose tolerance including prediabetes or diabetes mellitus, dyslipidemia, or liver dysfunction
6. Previous or current history of mood disorder, psychosis, or suicidality
7. Participants currently receiving ongoing treatment with methotrexate, tetracyclines, or other retinoids

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: up to 5 months
Secondary outcomes:
measure: Change in α4β7 expression on peripherally circulating CD4 T cells
timeFrame: Serial phlebotomy measured over 5 months
measure: Maximum Plasma Concentration [Cmax]
timeFrame: Trough concentrations measured serially over 2 months of active treatment
measure: Change in RIG-1 expression, p300 expression, mTOR expression
timeFrame: Serial phlebotomy measured over 5 months
measure: Area Under the Curve [AUC]).
timeFrame: Trough concentrations measured serially over 2 months of active treatment
Other outcomes:
Locations:
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Jonathan B Angel, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00921167: A Study to Evaluate the Efficacy of Bevacizumab Plus Irinotecan in Recurrent Gliomas
Official title: A Phase II Study to Evaluate the Efficacy of Bevacizumab Plus Irinotecan in Recurrent Anaplastic Astrocytoma or Recurrent Glioblastoma Multiforme
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glioblastoma
Astrocytoma
Keywords: Glioblastoma
Astrocytoma
Chemotherapy
Lead sponsor: Clinical Research Center for Solid Tumor, Korea
Sponsor class: OTHER
Collaborators: name: Seoul National University Hospital
First posted: 2009-06-16
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the efficacy and safety of bevacizumab plus irinotecan for the patients with recurrent anaplastic astrocytoma or with recurrent glioblastoma multiforme


Eligibility criteria: Inclusion Criteria:

* Histologically diagnosed recurrent anaplastic astrocytoma or recurrent glioblastoma multiforme
* At least 18 years of age
* Performance status of 0 and 1 on the Eastern Cooperative Oncology Group (ECOG) criteria
* One or more measurable disease
* Adequate hematologic (neutrophil count \>= 1500/uL, platelets \>= 100,000/uL), hepatic (transaminase =\< upper normal limit (UNL)x2.5, bilirubin level =\< UNLx1.5, alkaline phosphatase =\< UNLx2.5), and renal (creatinine clearance \>= 30mL/min)
* Expected life time more than at least 2 months
* A patients who signed the informed consent prior to the participation in the study

Exclusion Criteria:

* A pregnant or lactating patient
* A patient of childbearing potential without being tested for pregnancy at baseline or with a positive test. (A premenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential.)
* A man or woman of childbearing potential without the willingness to use a contraceptive measures during the study
* A patient with history of another malignant disease within past 3 years, except curatively treated basal cell carcinoma of the skin, cervical carcinoma in situ, and early gastric cancer
* Medically uncontrolled serious heart, lung, neurological, psychological, or metabolic disease
* Uncontrolled serious infection
* Enrollment in other study within 30 days
* Hemorrhage on baseline radiologic examination
* A patient who refused to sign the informed consent

Primary outcomes:
measure: Progression-free survival
timeFrame: 6 months, 1 year
Secondary outcomes:
measure: Objective response rate
timeFrame: 6 weeks, 12 weeks
measure: Overall survival
timeFrame: 6 months, 1 year
measure: Disease-control rate
timeFrame: 6 weeks, 12 weeks
measure: Adverse event
timeFrame: 3 weeks, 6 weeks, 9 weeks, 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT06882967: Active Thoracic Compromised Distal LANding in TEvar
Official title: Thoracic Endovascular Aortic Repair in Compromised Distal Landing Zones
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thoracic Aortic Aneurysm
Aortic Diseases
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-03-19
Enrollment: 200
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: All consecutive patients with compromised distal landing zone undergoing Thoracic Endovascular Aortic Repair in patients with distal active fixation stent-grafts, distal scallop stent-grafts, distal EndoAnchors, and standard stent-grafts in selected high volume aortic centers will be enrolled retrospectively with a prospective database

Brief summary: Thoracic endovascular aortic repair (TEVAR) has become the mainstay of aortic intervention for descending thoracic aortic pathology. Its durability hinges on achieving adequate seal in the endograft landing zones (LZs), with the distal LZ largely understudied. Only recently are suboptimal distal LZs receiving attention for their role in major complications including stent graft migration, type 1B endoleaks, and distal stent graft-induced new entry tears, all of which can contribute to further aortic degeneration. The thoracic distal LZ. When a short distal LZ was reported, the distal endoleak rate ranged from 3.5% to 33%. This led to reintervention in 19%, along with coverage of the celiac trunk in more than half of short LZ cases.

The objective of this study was to evaluate the outcomes of TEVAR patients with compromised distal landing zone (CDLZs) treated with distal active fixation stent-grafts (DAFs), distal scallop stent-grafts, distal Aptus Heli-FX EndoAnchors, and standard stent-grafts.


Eligibility criteria: Inclusion Criteria:

* Patients with descending thoracic aortic aneurysms (DTAAs) with a maximal aortic diameter \> 55mm or rapid growth (\>10mm / year).
* Patients presenting with at least 2 cognizable features related to an adverse aortic morphology will be considered for inclusion. The following features will be evaluated for the inclusion: distal LZ length ≤25-mm, distal LZ diameter ≥38-mm, LZ conical morphology, distal descending thoracic aorta angulation ≤116° or tortuosity index ≥1.4

Exclusion Criteria:

* Emergency setting, including hemodynamic instability at time of enrollment
* Patients with aortic dissection pathology

Primary outcomes:
measure: Ib Endoleak
timeFrame: Follow-up (at month 3)
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
state: RM
Study officials:
References:
Clinical trial NCT00824967: Non Pharmacological Management of Behavioural Symptoms in Nursing Home
Official title: Not Pharmacologic Treatment Has Illness of Alzheimer and Pathologies Related. Application in Disturbances of Behaviour in EHPAD
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: ALZHEIMER Disease
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2009-01-19
Enrollment: 306
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Background: Behavioural and psychological symptoms of dementia (BPSD) are often reported in institutions for the elderly.

Objective: To evaluate the effectiveness of a staff education intervention to manage BPSD in older people with a diagnosis of dementia.

Detailed description: Background: Behavioural and psychological symptoms of dementia (BPSD) are often reported in institutions for the elderly.

Objective: To evaluate the effectiveness of a staff education intervention to manage BPSD in older people with a diagnosis of dementia.

Methods: The trial was conducted in 16 nursing homes; 306 patients with a diagnosis of dementia and presenting BPSD were selected. Nursing homes were randomly allocated to an intervention group or a control group. An eight-week staff education and training programme was conducted in the nursing homes in the intervention group. The main outcome measures were the Cohen-Mansfield Agitation Inventory (CMAI) and an observation scale score. Assessments were done at baseline (W0), at the end of the 'intervention' period (W8) and 12 weeks after (W20).

Eligibility criteria: Inclusion Criteria:

* Alzheimer disease

Exclusion Criteria:

* Not alzheimer disease

Primary outcomes:
measure: Changes at the behavioural assessment (CMAI, OS, NPI) after 8 weeks of intervention
timeFrame: 8 weeks after intervention
Secondary outcomes:
measure: Changes at the behavioural assessment (CMAI, OS, NPI) 16 weeks after the end of the intervention
timeFrame: 16 weeks after intervention
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice - 4 avenue Reine Victoria
state: Alpes-Maritimes
Study officials:
affiliation: CHU de Nice - CM2R - Hôpital de Cimiez - 4 avenue reine victoria - 06 003 Nice cedex 1
name: Philippe ROBERT, PhD
role: PRINCIPAL_INVESTIGATOR
References: