louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02562092: The Georgia Latino AIDS/HIV Diagnosis and Linkage in Youth (GLADLY) Project
Official title: The Georgia Latino AIDS/HIV Diagnosis and Linkage in Youth (GLADLY) Project
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: HIV
Keywords: AIDS
Health Promotion
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2015-09-29
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study aims to understand the barriers to receiving HIV testing and retention of care for at risk and HIV positive young adults. This study also seeks to determine the feasibility and acceptability of HIV testing in a non-clinical setting.

Detailed description: This study aims to identify factors that can facilitate or impede the use of non-clinical HIV testing venues as well as identify potential testing sites and assess acceptability of an HIV prevention intervention. In addition, the study will implement a pilot intervention to test the feasibility non-clinical HIV testing and follow up events for HIV positive youth.

Eligibility criteria: Inclusion Criteria:

* Sexually active
* HIV positive or negative
* Latino youth ages 18-24 years
* Residents of the state of Georgia and can understand spoken and written English or Spanish.

Exclusion Criteria:

* Unmet inclusion criteria

Primary outcomes:
measure: Days to Linkage to Care
timeFrame: Post Diagnosis (Up to 3 months)
Secondary outcomes:
measure: Number of medical care visits
timeFrame: Post Diagnosis (Up to one year)
measure: Change in CD4 count
timeFrame: Baseline (Post Diagnosis), One year assessment (Up to one year)
measure: Change in viral load
timeFrame: Baseline (Post Diagnosis), One year assessment (Up to one year)
measure: Rate of venue acceptance
timeFrame: One year assessment (Up to one year)
measure: Rate of study subject acceptance
timeFrame: One year assessment (Up to one year)
measure: Change in HIV stigma scale score
timeFrame: Baseline (Post Diagnosis), One year assessment (Up to one year)
measure: Change in HIV-AIDS stress scale score
timeFrame: Baseline (Post Diagnosis), One year assessment (Up to one year)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
city: Atlanta
country: United States
facility: Ponce De Leon Center
state: Georgia
Study officials:
affiliation: Emory University
name: Andres Camacho-Gonzalez
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06147492: Urinary Retention Following taTME VS laTME Total Mesorectal Excision for Rectal Cancer
Official title: Urinary Retention Following Transanal Versus Laparoscopic Total Mesorectal Excision for Rectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Cancer
Keywords: urinary retention
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-11-27
Enrollment: 526
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: A comprehensive study with prospectively collected data. These patients were assigned to either the taTME group or the laTME group according to the surgery procedure received

Detailed description: Transanal total mesorectal excision has emerged as a potential solution to certain limitations associated with laparoscopic total mesorectal excision in rectal cancer patients. Differences in surgical approaches have raised questions regarding their impact on the risk of postoperative urinary retention, with limited data available from large scale study.

Eligibility criteria: Inclusion Criteria:

* Age range from 18 to 65 years,
* Diagnosed with rectal cancer at clinical tumor node metastasis stages II or III.
* Palpable tumor determined by digital rectal examination or proctoscopy
* The distal border of the tumor located within 12 cm from the anal verge

Exclusion Criteria:

* Patients presenting clear indications of pelvic side wall involvement or distant metastasis
* Uncontrolled hypertension or cardiovascular disease
* Patients with synchronous colon cancer
* History of other malignancies within the past 5 years

Primary outcomes:
measure: urinary retention
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04653792: Role Of Pregabalin To Decrease Postoperative Pain In Microdiscectomy
Official title: Role Of Pregabalin To Decrease Postoperative Pain In Microdiscectomy: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Nerve
Prolapsed Intervertebral Disc
Keywords: Microdiscectomy
Pregabalin
Lead sponsor: Ziauddin University
Sponsor class: OTHER
First posted: 2020-12-04
Enrollment: 84
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effect of pregabalin in reducing the neuropathic pain in postoperative patients who have undergone single level Microdiscectomy for prolapsed intervetebral lumbar disc.

Detailed description: All patients were informed in detailed regarding the risk and complications and given written and informed consent, coming to our clinics were assessed by one of the senior team members of the spine, patient fulfilling the eligibility criteria were selected and included in the study. One week before the surgery the patients who met the eligibility criteria were randomized in a double-blind manner (participant and investigator) in a ratio of 1:1 into Group-A (Pregabalin 7mg, twice daily) or Group-B (Placebo, twice daily). The pain scores were recorded by VAS and Roland Morris score system on preoperative day compared to the scores on the 1st week postoperative follow-up.

Eligibility criteria: Inclusion Criteria:

* All patients with severe CLBP and/or leg pain
* Patients with static or dynamic leg pain
* Patients with leg pain resulting from localized lumbar or lumbosacral segmental instability
* Spinal stenosis at levels L2-S1 or caused by isthmic spondylolisthesis (grade I and II)

Exclusion Criteria:

* Patients with previous lumbar surgery
* Patients allergic to gabapentinoids
* Patients with renal impairments
* Patients who are already on opioids, benzodiazepines, barbiturates, ethanol (alcohol)
* Patient presented with diabetes and other drugs that depress the central nervous system
* Patients who are already on ACE inhibitors as they may enhance the adverse/toxic effect of Pregabalin.

Primary outcomes:
measure: change from preoperative pain score using a 10 point visual analog scale (VAS pain scale) at 1 week post surgery for PID
timeFrame: Preoperative and one week postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dr. Ziauddin University Hospital Clifton Campus
state: Sindh
Study officials:
affiliation: Ziauddin University hospital Karachi
name: Shahzaib Riaz
role: PRINCIPAL_INVESTIGATOR
affiliation: Ziauddin University Hospital Karachi
name: Sohail Rafi, FCPS
role: STUDY_DIRECTOR
References:
Clinical trial NCT00216892: Efficacy and Safety of Calcipotriol Cream and (Calcipotriol + Betamethasone Dipropionate) Ointment in Psoriasis Vulgaris
Official title: Different Treatment Regimens of Calcipotriol Cream and Combination (Calcipotriol/Betamethasone Dipropionate) Ointment in Psoriasis Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis Vulgaris
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 1032
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: Patients with psoriasis vulgaris of the trunk and/or limbs are randomised to treatment with:

1. 4 weeks of ointment containing calcipotriol and betamethasone dipropionate followed by 8 weeks of calcipotriol cream
2. 4 weeks of (calcipotriol plus betamethasone dipropionate) ointment followed by 8 weeks of calcipotriol cream on weekdays/ (calcipotriol plus betamethasone dipropionate) ointment on weekends
3. 4 weeks of (calcipotriol plus betamethasone dipropionate) ointment followed by 8 weeks of vehicle of calcipotriol cream

The objective is to compare the efficacy and safety of the different treatment regimens

Detailed description: A phase IV study of different treatment regimens of calcipotriol 50 mcg/g cream and combination (calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)) ointment following treatment with combination ointment in psoriasis vulgaris

Eligibility criteria: Inclusion Criteria:

* Patients with psoriasis vulgaris of trunk and/or limbs

Exclusion Criteria:

-

Primary outcomes:
measure: Efficacy of regimen (a) versus regimen (c) by % change in PASI at week 12
Secondary outcomes:
measure: Efficacy of regimen (b) versus regimen (c) at week 12, safety of regimen (a) versus (c), safety of regimen (b) versus (c)
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Universitair Ziekenhuis
city: Hamilton
country: Canada
facility: Dermatrials Research Dermatology Centre
state: Ontario
city: Saint Etienne
country: France
facility: Hôpital Nord, Service de Dermatologie
city: Frankfurt
country: Germany
facility: Klinikum der Goethe-Universität, Zentrum für Dermatologie und Venerologie
city: Nijmegen
country: Netherlands
facility: Canisius-Wilhelmina Ziekenhuis
city: Terrassa
country: Spain
facility: Hospital Mutua de Terrassa Dermatology Service
city: Merseyside
country: United Kingdom
facility: Clatterbridge Hospital, Department of Dermatology
Study officials:
affiliation: Clatterbridge Hospital, Department of Dermatology
name: S White, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02100592: Early Verticalization in neuroICU With ERIGO: a Safety and Feasibility Study
Official title: Early Verticalization in neuroICU With ERIGO: a Safety and Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Brain Injury
Keywords: brain injury
coma
intensive care
early rehabilitation
Lead sponsor: Ospedale Generale Di Zona Moriggia-Pelascini
Sponsor class: OTHER
First posted: 2014-04-01
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Severe brain injuries induce alteration of state of consciousness. These functional limitations can be significantly alleviated by treatment neurorehabilitation, particularly if this is established early. It has been shown that treatment of vertical integration in patients in a vegetative state or minimally conscious state can improve the level of supervision and positive influence on rehabilitation. Therefore, there are sufficient indications that anticipate the treatment of vertical integration, since the phase of hospitalization in ICUs, may improve the functional outcome of the patient.

Detailed description: Early verticalization and stepping with the equipment Hocoma Erigo, during monitoring of vital parameters. The device Erigo is already CE marked and, for the purposes of the study, will be used in accordance with the intended use of the same mark (after-market clinical investigation).

Eligibility criteria: Inclusion Criteria:

1. Patient / a severe acquired brain injury occurred 3 to 30 days prior to enrollment
2. Age between 18 and 75 years
3. Glasgow Coma Scale ≤ 8 at entrance in ICUs
4. Adequate respiratory exchange with PaO2/FiO2 ≥ 250
5. Absence of sedation increased

Exclusion Criteria:

1. Major chest trauma with multiple rib fractures and / or pneumothorax
2. Presence of fractures, vascular lesions, skin lesions with loss of substance in the abdomen, pelvis or lower limb
3. Cardiovascular instability despite support with amines
4. Intracranial pressure (ICP)\> 25 mm / Hg
5. Cerebral Perfusion Pressure (PPC) \<60 mm / Hg
6. Severe kidney failure requiring replacement therapy
7. Decompensated liver disease
8. Hematocrit value of ≤ 30%
9. Body weight\> 135 kg or height\> 210 cm
10. Deep vein thrombosis

Primary outcomes:
measure: Adverse events during verticalization
timeFrame: 21 days: from T1 (first session) to T15 (last session)
Secondary outcomes:
measure: Changes of hemodynamic parameters
timeFrame: 21 days: from T1 (first session) to T15 (last session)
Other outcomes:
Locations:
Study officials:
affiliation: Ospedale generale di zona 'Moriggia Pelascini'
name: Giuseppe Frazzitta, MD
role: STUDY_CHAIR
affiliation: Ospedale generale di zona 'Moriggia Pelascini'
name: Roberto Valsecchi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: LDK Hochzirl
name: Leopold Saltuari, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale generale di zona 'Moriggia Pelascini'
name: Luca Sebastianelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02659592: Transplantation of Frozen Thawed Ovarian Tissue High Reproductive Performance
Official title: Transplantation of Frozen Thawed Ovarian Tissue Demonstrates High Reproductive Performance and the Need to Revise Restrictive Criteria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Reproductive Performance Following Ovarian Transplantation
Keywords: fertility preservation
ovarian tissue transplantation
ovarian endocrine function
assisted reproductive technology
pregnancy and live birth
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-01-20
Enrollment: 20
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Design: prospective cohort study. Setting: Tertiary university-affiliated ART and oncology centers. Patients: 20 cancer survivors who underwent ovarian transplantation of frozen-thawed ovarian tissue, with the aim to conceive.

Interventions: Ovarian tissue cryopreservation (OTCP) and transplantation, endocrine monitoring, IVF.

Detailed description: Main Outcomes expected:

Endocrine profile IVF results, pregnancy rates following transplantation of ovarian tissue live-births rates following transplantation of ovarian tissue cancer disease recurrence

Eligibility criteria: Inclusion Criteria: infertile patients who stored ovarian tissue to preserve fertility prior to potentially sterilizing cancer treatments

-

Exclusion Criteria:

* active disease, fertile patients post cancer treatment

Primary outcomes:
measure: menstrual bleeding (yes/no)
timeFrame: up to one year
measure: number of oocytes per IVF cycle
timeFrame: through study completion (up to 11 years following transplantation)
measure: pregnancies
timeFrame: through study completion (up to 11 years following transplantation)
measure: live births
timeFrame: through study completion (up to 11 years following transplantation)
Secondary outcomes:
measure: disease reccurence
timeFrame: through study completion (7 months to 141 months following transplantation)
Other outcomes:
measure: FSH levels (miU/ml)
timeFrame: up to one year
measure: E2 (pmol/ml),
timeFrame: up to one year
measure: number of embryos per IVF cycle
timeFrame: through study completion (up to 11 years following transplantation)
measure: IVF cycles pregnancy rates (%)
timeFrame: through study completion (up to 11 years following transplantation)
Locations:
Study officials:
References:
citation: Meirow D, Ra'anani H, Shapira M, Brenghausen M, Derech Chaim S, Aviel-Ronen S, Amariglio N, Schiff E, Orvieto R, Dor J. Transplantations of frozen-thawed ovarian tissue demonstrate high reproductive performance and the need to revise restrictive criteria. Fertil Steril. 2016 Aug;106(2):467-74. doi: 10.1016/j.fertnstert.2016.04.031. Epub 2016 May 12.
Clinical trial NCT04613544: Assess Safety, Efficacy and Usability of Application for Atrial Fibrillation Vocal Marker
Official title: A Prospective, Open Label, Multi-Center, Pilot Study to Assess Safety, Efficacy and Usability of Application for Atrial Fibrillation Vocal Marker
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Lead sponsor: Cardiokol Ltd
Sponsor class: INDUSTRY
First posted: 2020-11-03
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Atrial Fibrillation Diagnosed

Brief summary: Voice Assist Arrhythmia Monitoring (VAAM) is an application running on smartphones and/or landline phones that performs vocal tests for the monitoring of abnormalities in the heart rhythm.

Detailed description: Following ICF signature and process and eligibility confirmation, subject will have a training session to assure correct application use. The subjects will be asked to pronounce few vowels 3 times a day to be evaluated by the application analysis algorithm at the patient natural environment.

At the same time, a single lead ECG system will be recorded synchronously ECG for reference with the use of dedicated recording device

Eligibility criteria: Inclusion Criteria:

1. Female and male at age of ≥18 years and above.
2. All AF types Or Medical history of Cryptogenic stroke.
3. Ability and willingness to sign an informed consent form

Exclusion Criteria:

1. Subjects with implanted cardiac defibrillators or pacemakers neurostimulators and/or body worn medical devices such as insulin pumps.
2. Subjects diagnosed with any heart arrhythmias other than A-Fib, except for PVC.
3. Patient who underwent cardioversion or ablation in the last year and is in stable sinus rhythm.
4. Women who are pregnant or breastfeeding (women of child-bearing potential must provide a declaration stating that they are not pregnant)
5. Tremor or Parkinson's disease
6. Current hoarseness
7. Barriers for communication and lack of capability to execute the handlings required for this study.
8. Subjects who are currently enrolled in another clinical investigation. Parallel Enrollment to a non-interventional study is permitted.

Primary outcomes:
measure: Safety Assessment
timeFrame: 6 weeks
Secondary outcomes:
measure: Usability
timeFrame: 6 weeks
measure: Effectivness
timeFrame: 6 wweeks
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Petach tikva
country: Israel
facility: Rabin Medical Center
Study officials:
References:
Clinical trial NCT05580744: Augmented-reality Based Mirror Therapy in Stroke Rehabilitation
Official title: Effects of Augmented-reality Based Mirror Therapy on Sensorimotor Function of Upper Extremity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Rehabilitation
Technology
Mirror Movement Therapy
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the proposed study, the investigators assumed that mirror therapy combined with augmented reality technology will provide a better treatment effects than traditional mirror therapy for the patients with unilateral stroke. The aim of the study is to examine the difference in the treatment effects among the combination of task-oriented training with either augmented reality based mirror therapy, mirror therapy or traditional occupational therapy on the upper extremity function and brain activity of the stroke patients.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of stroke with unilateral side involved;
* A score of Mini-mental state examination greater than 24 for proving higher mental function
* Time of onset \> 6 months before treatment begins; and
* Premorbid right-handedness.

Exclusion Criteria:

* Severe vision impairment;
* Major cognitive-perceptual deficit;
* Other brain disease.

Primary outcomes:
measure: Change in the result of Fugl-Meyer assessment (FMA) for motor function of upper extremity test
timeFrame: baseline, 9 weeks and 21 weeks
Secondary outcomes:
measure: Change in the result of Modified Ashworth scale (MAS)
timeFrame: baseline, 9 weeks and 21 weeks
measure: Change in the result of Box and blocks test
timeFrame: baseline, 9 weeks and 21 weeks
measure: Change in the result of Semmes-Weinstein monofilament (SWM) test
timeFrame: baseline, 9 weeks and 21 weeks
measure: Change in the result of Motor Activity Log
timeFrame: baseline, 9 weeks and 21 weeks
Other outcomes:
measure: changes in oxygenated (HbO) and deoxygenated (Hb) hemoglobin concentrations using near infrared spectroscopy (NIRS)
timeFrame: baseline, 9 weeks and 21 weeks
Locations:
city: Tainan
country: Taiwan
facility: National Cheng-Kung University Hospital
Study officials:
References:
Clinical trial NCT01030744: Evaluation of the Gestational Diabetes Self-Management Education Program and Quality Improvement Plan
Official title: Evaluation of the Gestational Diabetes Self-Management Education Program and Quality Improvement Plan
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Gestational Diabetes
Keywords: Gestational Diabetes
Self-Monitoring of Blood Glucose
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2009-12-11
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with gestational diabetes who are referred to and followed in the Vanderbilt Eskind Diabetes Clinic and are participants in the gestational diabetes educational program.

Brief summary: The broad, long-term objectives are to generate and test hypotheses leading to theories that guide improved care of patients with gestational diabetes. The purpose of this chart review study is to evaluate the Vanderbilt Gestational Diabetes Self-Management Education Program and Quality Improvement Plan in optimizing metabolic control and improving health outcomes during pregnancy with gestational diabetes.


Eligibility criteria: Inclusion Criteria:

* Women with gestational diabetes who are referred to and followed in the Vanderbilt Eskind Diabetes Clinic and are participants in the gestational diabetes educational program.

Exclusion Criteria:

* Refusal of consent.

Primary outcomes:
measure: Self-Monitoring of Blood Glucose
timeFrame: chart review quarterly during course of study
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University : Vanderbilt Diabetes Center (VDC)
state: Tennessee
Study officials:
References:
Clinical trial NCT00294944: The Effectiveness of Idazoxan in Treating TRD
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-02-22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Assessing the effectiveness of Idazoxan as a treatment for depressive patients who did not respond to treatment with SSRI


Eligibility criteria: Inclusion Criteria:

* MDD patients
* Did not respond to at least one treatment of 4-6 weeks of SSRI in adequate dose
* In or out patients

Exclusion Criteria:

* Psychotic symptoms

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Chaim Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Joseph Zohar, MD
role: PRINCIPAL_INVESTIGATOR
References: