louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05597787: HIV-Related Stigma Intervention for Malaysian Clinicians
Official title: Implementing Stigma Reduction Tools Via a Popular Teletraining Platform to Reduce Clinician Stigma and Disparities in HIV Testing, Prevention, and Linkage to Care in Malaysia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hiv
Lead sponsor: University of Delaware
Sponsor class: OTHER
Collaborators: name: University of Malaya
First posted: 2022-10-28
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Key populations at risk of HIV (including men who have sex with men, people who inject drugs, transgender women, and female sex workers) are more likely to be infected with HIV but less likely than members of the general population to know of their HIV status, receive HIV prevention counseling, or be linked to HIV care services. Clinician stigma towards these groups remains a potent and persistent driver of these HIV disparities in many places of the world. The investigators propose to incorporate evidence-based stigma reduction tools into a popular teletraining platform for clinicians and pilot test the resulting intervention (Project ECHO® for HIV Prevention and Stigma Reduction) with clinicians in Malaysia, a context wherein clinician stigma and HIV disparities are substantial.


Eligibility criteria: Inclusion Criteria:

* practicing general practitioner or family medicine specialist in Malaysia

Exclusion Criteria:

-

Primary outcomes:
measure: Acceptability of Intervention
timeFrame: Month 9 Assessment
measure: Feasibility of Intervention
timeFrame: Month 9 Assessment
measure: Stigma Reduction: Prejudice
timeFrame: Month 9 Assessment
measure: Stigma Reduction: Stereotypes
timeFrame: Month 9 Assessment
measure: Stigma Reduction: Discrimination
timeFrame: Month 9 Assessment
Secondary outcomes:
measure: HIV Prevention Procedures: HIV Testing
timeFrame: Cumulative over 9 month intervention
measure: HIV Prevention Procedures: PrEP Prescriptions
timeFrame: Cumulative over 9 month intervention
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya
Study officials:
References:
Clinical trial NCT03222687: Tacrolimus in Children With Henoch-Schönlein Purpura Nephritis
Official title: Off-label Use of Tacrolimus in Children With Henoch-Schönlein Purpura Nephritis: Effectiveness and Safety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Henoch-Schönlein Purpura Nephritis
Keywords: tacrolimus, Henoch-Schönlein purpura nephritis, children
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2017-07-19
Enrollment: 25
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Henoch-Schönlein purpura (HSP) is the most common vasculitis in children, with an incidence of approximately 10:100 000 children and a slight male predominance (male-to-female ratio of 1.5:1). Henoch-Schönlein purpura nephritis (HSPN) is the principal cause of morbidity for HSP and 1%-7% of HSPN patients may progress to renal failure or end-stage renal disease.

Immunosuppressive therapy has become the standard treatment in children with HSPN, however the use of these drugs are still mainly in an off-label manner in clinical practice. Tacrolimus, a calcineurin inhibitor, has been recently suggested in the treatment of HSPN in children. However, the evidence-based clinical data are still limited.

Given the potential benefits and unmet need in clinical practice, the purposes of this pilot study were to assess effectiveness and safety of tacrolimus in HSPN children and evaluate the potential impact of CYP3A5.


Eligibility criteria: Inclusion Criteria:

HSPN children Aged less than 18 years; receiving tacrolimus as initial immunosuppressive therapy -

Exclusion Criteria:

Children received other immunosuppressive drug before the trial or other systemic trial drug therapy; Children had a concomitant medical condition, whose participation, in the opinion of the Investigator and/or medical advisor, may create an unacceptable additional risk.

-

Primary outcomes:
measure: Complete remission
timeFrame: within 6 months
measure: Partial remission
timeFrame: within 6 months
measure: nonresponsive
timeFrame: within 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Shandong University
name: Wei Zhao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00999687: Evaluation of the Efficacy and Safety of Indigo Naturalis Oil Extract on Psoriatic Nails
Official title: Evaluation of the Efficacy and Safety of Indigo Naturalis Oil Extract on Psoriatic Nails
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Nail Psoriasis
Keywords: Nail psoriasis
Indigo naturalis
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2009-10-22
Enrollment: 31
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate efficacy and safety of indigo naturalis oil extract in treating nail psoriasis.

Detailed description: Nail psoriasis treatment is notoriously difficult. While indigo naturalis has been demonstrated safe and effective in treating skin psoriasis, its effect on nail psoriasis remains unverified.

Eligibility criteria: Inclusion criteria:

1. adults aged between 20 and 65 years
2. received a diagnosis of nail psoriasis with at least one year history based on clinical assessment by two dermatologists and failure of topical systemic Chinese herbal anti-psoriasis therapy for fingernail psoriasis.
3. Female patients of childbearing age agreed to continue using birth control measures for the duration of the study.

Exclusion criteria:

1. Patients had non-plaque (i.e., pustular, guttate, or erythrodermic) or drug-induced forms of psoriasis, total body surface involvement of more than 60%
2. a history of allergy to indigo naturalis, or with onychomycosis or any fingernail infection.
3. Patients have received systemic therapy within four weeks before enrollment
4. Patients have received phototherapy within three weeks, or topical psoriasis agents within two weeks.
5. Using medications which affect psoriasis during the study and unwillingness to comply with study protocol.

Primary outcomes:
measure: Change From Baseline in Single-Hand Nail Psoriasis Severity Index (NAPSI)and in the Modified Target NAPSI for the Single Most Severely Affected Nail of Each Hand at Week 12.
timeFrame: Baseline and Week 12
measure: Change From Baseline in Single-Hand Nail Psoriasis Severity Index (NAPSI)and in the Modified Target NAPSI for the Single Most Severely Affected Nail of Each Hand at Week 24.
timeFrame: Baseline and Week 24
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Yin-Ku Lin, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04960293: Spherical Gelfoam Versus Tri-acryl Microsphere for Uterine Artery Embolization for Symptomatic Fibroids
Official title: "Comparison of Pain After Uterine Artery Embolization Using Spherical Gelfoam or Tris-acryl Gelatin Microsphere in Patients With Symptomatic Fibroids: A Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Symptomatic Uterine Fibroids
Keywords: Fibroid
Embolization
Pain
Inflammation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2021-07-13
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to compare pain after uterine artery embolization using spherical gelfoam or tris-acryl gelatin microsphere in patients with symptomatic fibroids

Detailed description: Uterine artery embolization(UAE) is a minimally invasive treatment alternative to hysterectomy and myomectomy in symptomatic fibroids. However, post-procedural pain after UAE remains a major problem. The spherical gelfoam and tri-acryl gelatin microsphere are two embolic materials used for UAE. Therefore, the aim of study is to compare pain intensity and inflammation after uterine artery embolization using the two embolic agents with symptomatic fibroids.

Eligibility criteria: Inclusion Criteria:

1. Women with symptomatic fibroids (age: 20 - 60 years old)

Exclusion Criteria:

1. Bradycardia (\<45 bpm)
2. Conduction abnormalities
3. Liver failure
4. renal failure
5. Uncontrolled hypertension
6. High grade obesity (BMI ≥ 30 kg/m2)
7. Drug allergy
8. Illiteracy
9. Pregnancy

Primary outcomes:
measure: Pain score (VAS score)
timeFrame: up to 24 hours after embolization
Secondary outcomes:
measure: C-reactive protein (mg/L)
timeFrame: the day before and 24 hours after embolization
measure: Tumor necrosis rate after embolization
timeFrame: 1 day and 3 months after embolization
measure: Symptom severity questionnaire
timeFrame: before and 3 months after embolization
measure: White blood cell count (/µL)
timeFrame: the day before and 24 hours after embolization
measure: Neutrophil percentage (%)
timeFrame: the day before and 24 hours after embolization
measure: Cumulative fentanyl dose (µg)
timeFrame: within 24 hours after embolization
measure: Use of rescue analgesics (%)
timeFrame: within 24 hours after embolization
measure: Lymphocyte percentage (%)
timeFrame: the day before and 24 hours after embolization
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
Study officials:
affiliation: Department of Radiology, Severance hospital
name: Man-Deuk Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02104193: Simvastatin Effect on Radiation Therapy of Brain Metastases
Official title: The Effect of Simvastatin on the Clinical Outcome of Patients With Brain Metastases Treated With Radiation Therapy: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Brain Metastases
Keywords: brain metastases
simvastatin
radiation therapy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2014-04-04
Enrollment: 50
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: The purpose of the study is to evaluate the effect of simvastatin in combination with radiotherapy on the clinical outcomes of patients with brain metastases.

Detailed description: Despite current advances in therapies, the outcome for patients with brain metastases is fatal. New therapeutic approaches, such as radiosensitizing agents, are needed to provide a significant survival advantage for those patients. Statins have been reported to enhance the efficacy of radiotherapy in addition to a neuroprotective effect. The aim of the study is to evaluate the effect of simvastatin on the efficacy and safety of radiation therapy in patients with brain metastases and on improving patients' quality of life.

Eligibility criteria: Inclusion Criteria:

* Patients with measurable brain metastases
* Age more than 18 years old
* Patients should be planned for radiation therapy

Exclusion Criteria:

* Renal dysfunction (more than 1 upper normal level)
* Hepatic dysfunction (alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>3 times the upper normal level )
* Pregnancy or lactation.
* Known hypersensitivity to simvastatin

Primary outcomes:
measure: a- Response rate
timeFrame: 4 weeks after radiation therapy
Secondary outcomes:
measure: progression free and overall survival
timeFrame: up to 6 months
measure: adverse effects
timeFrame: during the treatment period
Other outcomes:
measure: quality of life
timeFrame: baseline, after radiation therapy, 6 weeks, 18 weeks, 30 weeks
measure: cognitive function assessment using Montreal cognitive assessment test
timeFrame: baseline, after radiation therapy, 6 weeks, 18 weeks, 30 weeks
measure: serum s100 B protein
timeFrame: baseline, after radiation therapy
Locations:
city: Cairo
country: Egypt
facility: Ain Shams university Hospitals
Study officials:
affiliation: Faculty of Pharmacy- Ain Shams university
name: May A Shawki, master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02312193: Evaluation of the Signaling Path of Emiline1-TGFβ in the Myogenic Tone of Resistance Arteries in a Population of Normotensive and Hypertensive Subjects
Official title: Evaluation of the Signaling Path of Emiline1-TGFβ in the Myogenic Tone of Resistance Arteries in a Population of Normotensive and Hypertensive Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: hypertension
myogenic tone
Lead sponsor: Neuromed IRCCS
Sponsor class: OTHER
First posted: 2014-12-09
Enrollment: 95
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects will be selected from patients hospitalized in the Department of Neurosurgery of the IRCCS Mediterranean Neurological Institute Neuromed, according to specific inclusion criteria and undergoing surgery for disc disease. Subjects included in the study will be normotensive and hypertensive patients. Approximately 70 subjects of both genders (35 normotensive, 35 hypertensive) aged between 30 and 70 years old will be included in the study. All the enrolled patients must have an indication for neurosurgical intervention.

Brief summary: Aim of this study is to enhance the knowledge of myogenic tone alterations in hypertensive patients and to better understand the mechanisms controlling the myogenic tone. Evaluations will be performed through ex vivo studies of peripheral arterioles in human adipose tissue from lumbar muscle, isolated from biopsies. This will allow investigators to evaluate the myogenic function in response to progressive blood pressure increases, in order to correlate myogenic function to arterial hypertension and to the molecular mechanisms already identified in the preclinical models.


Eligibility criteria: Inclusion Criteria:

* Males or females between 30 and 70 years of age
* Hypertensive patients: Patients with a previous diagnosis of hypertension
* Normotensive patients: subjects without story of hypertension
* Written informed consent

Exclusion Criteria:

* Severe hypertension (eg, systolic \>180 mm Hg, diastolic \>110 mm Hg)
* Manifested or suspected secondary hypertension (coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, pheochromocytoma)
* History of cardiac complications (previous acute myocardial infarction (AMI), unstabile angina, percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass grafting (CABG), congestive heart failure (NYHA II-IV))
* Diabetes mellitus
* Renal pathologies (creatinine clearance \< 30 ml/min)
* Severe hepatic dysfunction

Primary outcomes:
measure: Myogenic tone measured by micromyographic technique to evaluate small-artery morphology.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pozzilli
country: Italy
facility: IRCCS Neuromed
state: Isernia
Study officials:
References:
Clinical trial NCT02760693: Bipolar Cohort Neunkirchen, Final Statement
Official title: SPICS (Secure Platform for Integrating Clinical Studies) for Recurrent (Bipolar) Affective Disorders for Long Term Follow up Treatment Regiments and Outcome in a Natural Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Keywords: bipolar disorder, naturalistic cohort study,
defined catchment area,long term treatment
Lead sponsor: Österreichische Gesellschaft für Bipolare Erkrankungen
Sponsor class: OTHER
First posted: 2016-05-04
Enrollment: 515
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community of wiener neustadt and neunkirchen

Brief summary: monitoring system and data base for long term follow up of various treatment strategies in a naturalistic setting of recurrent affective disorders (unipolar, bipolar) open study design, prospective \& retrospective

Detailed description: all hospitalized patients of a defined mixed urban and more rural area were consecutively interviewed at admission and entered into the data base. at discharge they gave written informed consent for further tracking and interviews.

Eligibility criteria: Inclusion Criteria:

* bipolar

Exclusion Criteria:

* all other diagnoses

Primary outcomes:
measure: relapses, hospital admissions, number of participants with adverse events as a measure of safety and tolerability
timeFrame: patients from the cohort are contacted once a year (1 to 6 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Wiener Neustadt
country: Austria
facility: BIPOLAR Zentrum Wiener Neustadt
state: Lower Austria
Study officials:
affiliation: Bipolar Zentrum WN
name: Christian A. Simhandl
role: PRINCIPAL_INVESTIGATOR
References:
citation: Simhandl C, Radua J, Konig B, Amann BL. The prevalence and effect of life events in 222 bipolar I and II patients: a prospective, naturalistic 4 year follow-up study. J Affect Disord. 2015 Jan 1;170:166-71. doi: 10.1016/j.jad.2014.08.043. Epub 2014 Sep 6.
citation: Simhandl C, Radua J, Konig B, Amann BL. Prevalence and impact of comorbid alcohol use disorder in bipolar disorder: A prospective follow-up study. Aust N Z J Psychiatry. 2016 Apr;50(4):345-51. doi: 10.1177/0004867415585855. Epub 2015 May 13.
citation: Simhandl C, Konig B, Amann BL. A prospective 4-year naturalistic follow-up of treatment and outcome of 300 bipolar I and II patients. J Clin Psychiatry. 2014 Mar;75(3):254-62; quiz 263. doi: 10.4088/JCP.13m08601.
Clinical trial NCT00826293: The Clinical Efficacy of Belting Stabilization for Shoulder Pain
Official title: The Clinical Efficacy of Belting Stabilization for Shoulder Pain: A Double Blinded Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rotator Cuff Impingement Syndrome
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2009-01-22
Enrollment: 64
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: TREATMENT

Brief summary: Application of a belt for stabilization while exercising accelerate and optimize recovery in patients diagnosed with shoulder impingement syndrome.

Detailed description: Stabilization through belts is commonly used as an adjunct for treatment of musculoskeletal problems. Although this treatment is popular among clinicians, there is a paucity of evidence on its use for shoulder pathology. The objective of this double-blinded longitudinal randomized controlled trial (RCT) is to determine the clinical efficacy of stabilization belting applied to patients receiving rehabilitation treatment for shoulder impingement syndrome. The study population will include patients who have been referred to the physiotherapy department of the Holland Orthopaedic \& Arthritic Centre for conservative treatment. Patients will be randomized into the treatment and control groups. The primary outcome measure is the Quick Disabilities of Arm, Shoulder and Hand (QuickDASH) questionnaire.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of impingement syndrome or post-surgical stiffness with an abnormal scapulothoracic rhythm

Exclusion Criteria:

* Inability to speak or read English
* Evidence of major joint trauma causing fracture
* Infection
* Underlying metabolic or inflammatory disease
* Avascular necrosis
* Frozen shoulder
* Major medical illness
* Psychiatric illness that precluded informed consent

Primary outcomes:
measure: The Primary outcome measure is a subjective measure, the Quick Disability of the Arm, Shoulder and Hand (QuickDASH)
timeFrame: Outcome measures are collected before the initial treatment, at 3 weeks, and at 6 weeks following the initial treatment
Secondary outcomes:
measure: The secondary subjective outcomes include a joint specific measure, the American shoulder and Elbow Surgeons (ASES) score, and the work limitation questionnaire (WLQ-25).
timeFrame: Outcome measures are collected before the initial treatment, at 3 weeks, and at 6 weeks following the initial treatment
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Holland Orthopaedic and Arthritic Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Helen Razmjou, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02941393: Internal Versus External Tocodynamometry and Labor Outcome
Official title: Influence of Measurement Method of Labor Contractions on Labor Outcome and Newborn
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dystocia
Contractions
Keywords: internal tocodynamometry, external tocodynamometry, cesarean section, labor, newborn, vacuum extraction, dystocia
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Central Finland Hospital District
First posted: 2016-10-21
Enrollment: 1500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, parturients will be randomized to either internal or external tocodynamometry contractions' follow up. Investigators recruit primiparous, those who try to have vaginal birth after cesarean section and multiparous, who need oxytocin during labor. Primary endpoint is the number of operative labors in each group. Secondary endpoints are the duration of labor, the use of oxytocin and the condition of the newborn.


Eligibility criteria: Inclusion Criteria:

* gestational age ≥ 37 weeks
* singleton pregnancy
* a fetus in cephalic position
* normal cardiotocograph in the time of randomization
* cervical ripening \< 7 cm
* either 1) primipara, 2) multipara, who needs oxytocin during first stage of labor or 3) parturients with previous cesarean section

Exclusion Criteria:

* parturient with hepatitis or HIV or other significant viral infection
* Acute infections (fever over 37,5, or C-reactive protein over 20) in the time of randomization
* Estimated fetal weight over 4,5 kg
* Suspected fetal abnormality

Primary outcomes:
measure: Number of cesarean sections
timeFrame: through study completion, an average of 6 years
measure: Number of operative vaginal deliveries
timeFrame: through study completion, an average of 6 years
Secondary outcomes:
measure: Duration of labor
timeFrame: From time of first regular contraction to birth
measure: Newborn admission to the pediatric care unit
timeFrame: 3 days after birth
measure: The use of Oxytocin during labor
timeFrame: From beginning of the use of oxytocin to the birth
measure: Apgar scores
timeFrame: 10 min after birth
measure: Ph of umbilical artery
timeFrame: immediately after birth
Other outcomes:
Locations:
city: Jyväskylä
country: Finland
facility: Cetral Finland Central Hospital
state: Central Finland
city: Tampere
country: Finland
facility: Tampere University Hospital
state: Pirkanmaa
Study officials:
affiliation: Central Finland Central Hospital, Tampere University
name: Tuija Hautakangas, MD
role: PRINCIPAL_INVESTIGATOR
References: