louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00005415: Physical Activity Effects on Health Care Utilization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To determine the magnitude of the relationship between physical activity level and subsequent health care utilization over a seven to ten week period in a general population.

Detailed description: BACKGROUND:

In recent years, the benefits of a physically active lifestyle have been well established with respect to chronic health problems such as coronary heart disease, hypertension, obesity and osteoporosis. However, the extent to which physical activity influences health care utilization is less clear. If physical activity levels are inversely associated with utilization patterns, then policies encouraging exercise may produce short-term reduction in health care costs.

DESIGN NARRATIVE:

A multivariate regression analysis was conducted for a representative sample of more than 600 adults who participated in a longitudinal field trial of health risk appraisal instruments. Using the Harvard Alumni Activity Survey as the physical activity measure, the analysis controlled for a variety of predisposing, enabling, and need characteristics that also influenced utilization behavior.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02564185: Prospective, Randomized Study of the Impact of a Education Program for Patients Suffering From Low Back Pain
Official title: Prospective, Randomized Study of the Impact of a Education Program for Patients Suffering From Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2015-09-30
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: According to the WHO, therapeutic education is intended to help patients acquire or maintain the skills they need to optimally manage living with a chronic disease. Low back pain is frequent and therapeutic education could be a promising option.

The purpose of the study is to evaluate the impact of a therapeutic education program for patients suffering from low back pain.


Eligibility criteria: Inclusion Criteria:

* Low back pain
* Treatment with transcutaneous electrical nerve stimulation (TENS)

Exclusion Criteria:

* Contra-indication of TENS
* Patients with mental disorders
* Lack of autonomy or patients living alone at home without help
* Concomitant inclusion in another research on the treatment of pain

Primary outcomes:
measure: Quality of life
timeFrame: 6 months
measure: Quality of life
timeFrame: 6 months
Secondary outcomes:
measure: Pain
timeFrame: 6 months
measure: Neuropathic pain
timeFrame: 6 months
measure: Social impact
timeFrame: 6 months
measure: Evaluation of the program
timeFrame: 6 months
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
References:
Clinical trial NCT06941285: Montreal Cognitive Assessment Index Following MRI Guided Focused Ultrasound Thalamotomy
Official title: Montreal Cognitive Assessment Index Following MRI Guided Focused Ultrasound
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Essential Tremor
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2025-04-23
Enrollment: 142
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that underwent MRI guided focused ultrasound thalamotomy and suffered from Essential tremor.

Brief summary: We assessed Montreal Cognitive Assessment scores before and after MRI guided focused ultrasound thalamotomy for tremor in order to identify if there are changes in cognitive function following treatment.

Detailed description: All patients who underwent MRI guided focused ultrasound thalamotomy underwent cognitive assessment by Montreal Cognitive Assessment. We calculated the scores before and after treatment and compared the results.

Eligibility criteria: Inclusion Criteria:

* Patients that underwent MRI guided focused ultrasound thalamotomy and suffered from Essential tremor.

Exclusion Criteria:

* Patients that did not undergo MRI guided focused ultrasound thalamotomy
* Patinets that did not suffer from Essential tremor.
* Patients that underwent MRI guided focused ultrasound for areas other then a thalamus
* Patients tat underwent bilateral thalamothomy

Primary outcomes:
measure: Montreal Cognitive Assessment
timeFrame: baselin, preprocedure, 6 months and 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rambam Health Care Campus
name: Inna Senderova
role: STUDY_DIRECTOR
References:
Clinical trial NCT01099085: Trial of XP (Capecitabine/CDDP) Simvastatin in Advanced Gastric Cancer Patients
Official title: Placebo-controlled, Double-blinded Phase III Trial of XP (Capecitabine/CDDP) Simvastatin in Advanced Gastric Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Cancer
Keywords: gastric cancer, unresectable/metastatic
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2010-04-06
Enrollment: 207
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: Based on antitumor activity of statin, we designed a phase III study of capecitabine/CDDP chemotherapy plus a low-dose simvastatin that is equivalent to cardiovascular dose in advanced gastric cancer patients.


Eligibility criteria: Inclusion Criteria:

1. histologically or cytologically confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction adenoca (i.e. an adenocarcinoma with \> 50% extension in the stomach)
2. patients must present with stage IV disease not amenable to surgery, radiation or combined modality therapy with curative intent. Patients previously undergoing local treatment (surgery and/or radiation) must have subsequently progressed or recurred
3. measurable or evaluable disease according to RECIST
4. age, 18 years or older
5. ECOG performance status 0 - 2
6. adequate organ function as defined by the following criteria absolute neutrophil count (ANC) ≥ 1,500/ul platelets ≥ 100,000/ul AST/ALT ≤ 2.5 x ULN, ≤ 5.0 x ULN if liver involvement Total serum bilirubin ≤ 3.0 mg/dL
7. signed written informed consent

Exclusion Criteria:

1. severe co-morbid illness and/or active infections
2. pregnant or lactating women
3. active CNS metastases not controllable with radiotherapy or corticosteroids
4. active and uncontrollable bleeding from gastrointestinal tract
5. known history of hypersensitivity to study drugs
6. patients who are already on statin treatment for hyperlipidemia control (if ≥ 1 year interval from the last statin dose, the patient is eligible for study entry)

Primary outcomes:
measure: Progression free survival of XP ± simvastatin
timeFrame: 1-year PFS
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Cancer Center
Study officials:
References:
citation: Kim ST, Kang JH, Lee J, Park SH, Park JO, Park YS, Lim HY, Hwang IG, Lee SC, Park KW, Lee HR, Kang WK. Simvastatin plus capecitabine-cisplatin versus placebo plus capecitabine-cisplatin in patients with previously untreated advanced gastric cancer: a double-blind randomised phase 3 study. Eur J Cancer. 2014 Nov;50(16):2822-30. doi: 10.1016/j.ejca.2014.08.005. Epub 2014 Sep 15.
Clinical trial NCT02674685: Vfend Special Investigation For Prophylaxis
Official title: VFEND SPECIAL INVESTIGATION FOR PROPHYLAXIS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fungal Infection
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2016-02-04
Enrollment: 241
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The subjects who have been treated with voriconazole for prophylaxis of invasive fungal infections in patients undergoing HSCT (Hematopoietic Stem Cell Transplantation)

Brief summary: Examine the safety and effectiveness of Vfend \[voriconazole\] for prophylaxix use under general clinical practices.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing HSCT (Hematopoietic Stem Cell Transplantation).

Exclusion Criteria:

* Patients who have been previously enrolled in this study.

Primary outcomes:
measure: Number of Participants With Adverse Drug Reactions
timeFrame: Maximum 3 years
Secondary outcomes:
measure: Number of Participants With Adverse Drug Reactions Not Expected From the Approved Local Product Document (Unknown Adverse Drug Reactions)
timeFrame: Maximum 3 years
measure: Proportion of Participants With Adverse Drug Reactions by Age
timeFrame: Maximum 3 years
measure: Proportion of Participants With Adverse Drug Reactions by Reason for Use
timeFrame: Maximum 3 years
measure: Proportion of Participants With Adverse Drug Reactions by Long-term Use
timeFrame: Maximum 3 years
measure: Proportion of Participants Who Developed Invasive Fungal Infections (IFI Rate)
timeFrame: Maximum 3 years
measure: Proportion of Participants Who Developed Invasive Fungal Infections (IFI Rate) by Age
timeFrame: Maximum 3 years
measure: Proportion of Participants Who Developed Invasive Fungal Infections (IFI Rate) by Reason for Use
timeFrame: Maximum 3 years
measure: Proportion of Participants With Successful Prophylaxis of Invasive Fungal Infections (Success Rate)
timeFrame: Maximum 3 years
measure: Proportion of Participants With Successful Prophylaxis of Invasive Fungal Infections (Success Rate) by Age
timeFrame: Maximum 3 years
measure: Proportion of Participants With Successful Prophylaxis of Invasive Fungal Infections (Success Rate) by Reason for Use
timeFrame: Maximum 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01396785: Topical Antifungal Treatment for Tinea Pedis
Official title: A Randomized, Multi-Center, Double-Blind, Vehicle-Controlled Study Evaluating the Efficacy and Safety of Product 33525 in Subjects With Tinea Pedis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tinea Pedis
Keywords: Tinea Pedis
Antifungal
Lead sponsor: Medicis Global Service Corporation
Sponsor class: INDUSTRY
First posted: 2011-07-19
Enrollment: 321
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if a topical antifungal cream is safe and effective for the treatment of tinea pedis.


Eligibility criteria: Inclusion Criteria:

* Moderate erythema, moderate scaling, and mild pruritus

Exclusion Criteria:

* Pregnancy and allergies

Primary outcomes:
measure: Proportion of patients achieving complete clearance
timeFrame: Day 42
Secondary outcomes:
measure: Proportion of patients achieving effective treatment
timeFrame: Day 42
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Paramus
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Hershey
country: United States
state: Pennsylvania
city: Austin
country: United States
state: Texas
city: College Station
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Cidra
country: Puerto Rico
Study officials:
affiliation: Medicis Pharmaceutical
name: Ron Staugaard
role: STUDY_DIRECTOR
References:
Clinical trial NCT05359185: Empowering Families Project
Official title: Empowering Families Project: An RCT of the Effects of Relationship Education With and Without Ancillary Economic Services on Family Outcomes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Couples
Relationship, Marital
Relational Problems
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
First posted: 2022-05-03
Enrollment: 666
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This RCT will test the marginal benefit of adding economic-focused services to traditional relationship education (RE) interventions. 344 couples will be randomly assigned to the RE only or RE plus economic-services condition. All couples will be assessed at baseline, 6-weeks, 6-months, and 12-months. This project will examine whether couples in the RE plus condition have better relationship and economic outcomes than couples in the RE only condition.


Eligibility criteria: Inclusion Criteria:

* couples involved in a romantic relationship

Exclusion Criteria:

* current domestic violence or child maltreatment

Primary outcomes:
measure: Change in Relationship satisfaction
timeFrame: From baseline to 6-weeks, 6-months, 12-months
measure: Changes in Positive Communication
timeFrame: From baseline to 6-weeks, 6-months, 12-months
measure: Changes in Negative Communication
timeFrame: From baseline to 6-weeks, 6-months, 12-months
measure: Changes in Income
timeFrame: From baseline to 6-months, 12-months
measure: Changes in Financial Strain
timeFrame: From baseline to 6-months, 12-months
measure: Changes in Financial Capability
timeFrame: From baseline to 6-months, 12-months
Secondary outcomes:
measure: Changes in Support and Affection
timeFrame: From baseline to 6-weeks, 6-months, 12-months
measure: Changes in Wealth
timeFrame: From baseline to 6-months, 12-months
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: The Parenting Center
state: Texas
Study officials:
References:
Clinical trial NCT06812585: The Effect of Metformin As an Adjuvant Therapy on Immunological Parameters in Egyptian Patients with RRMS: a Pilot Study
Official title: The Effect of Metformin As an Adjuvant Therapy on Immunological Parameters in Egyptian Patients with RRMS: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Sclerosis (MS) - Relapsing-remitting
Lead sponsor: German University in Cairo
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This pilot study aims to investigate the tolerability and feasibility of using metformin as an adjuvant treatment for RRMS. Also, it aims to evaluate the preliminary evidence of its efficacy by analyzing outcomes related to immunology, clinical manifestations, and radiological findings.


Eligibility criteria: Inclusion Criteria:

* Individuals between 18 and 50 years of age who met the 2017 McDonald criteria were recruited.
* Patients with RRMS and had an EDSS score below 7.0.
* Participants were required to have been on a stable IFNβ-1a regimen for at least six months before the commencement of the study.

Exclusion Criteria:

* Individuals taking metformin or other diabetes medications, pregnant, and breastfeeding females were excluded.
* Those with congestive heart failure, liver impairment, kidney dysfunction, or chronic respiratory conditions were not eligible to participate.
* Additionally, patients who had undergone corticosteroids before or within 4 weeks of the study's commencement were ineligible for participation.

Primary outcomes:
measure: Change in serum levels of neurofilament light chain in both arms
timeFrame: After 6 months
Secondary outcomes:
measure: Change in serum levels of nuclear factor kappa B in both arms
timeFrame: After 6 months
measure: Degree of remyelination visualized by MRI, it depends on clinician's overview.
timeFrame: After 6 months
measure: Degree of disability assessed by Expanded Disability Status Scale.
timeFrame: After 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Nasser Institute for Research and Treatment
Study officials:
References:
Clinical trial NCT01160185: Meta-analysis of Efficacy of Topotecan
Official title: Meta-analysis of Efficacy of Topotecan and Other Treatments for Recurrent Carcinoma of the Cervix
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Intraepithelial Neoplasia
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-07-12
Enrollment: 1
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The search was designed to identify all clinical data published since the Cancer Care Ontario systematic review in 2006. The Cancer Care Ontario systematic review searched MEDLINE (1966 to February 2006), EMBASE (1980 to February 2006), the Cochrane Library (Cochrane Database of Systematic Reviews (2006 Issue 1), and Cochrane Controlled Trials Register (2006 Issue 1)), the Canadian Medical Association Infobase, and the National Guidelines Clearinghouse. The conference proceedings of the American Society of Clinical Oncology (1995-2005) and the European Society of Medical Oncology (2002-2005) were also searched. The search was conducted on 18 December 2008.

Brief summary: This meta-analysis was conducted to investigate the efficacy of Topotecan and other treatments for recurrent and stage IVB carcinoma of the cervix

Detailed description: Studies included in the meta-analysis were: GOG-0179, GOG-0204 \& GOG-0169

Eligibility criteria: Inclusion Criteria:

* Randomised Clinical Trials or systematic reviews or meta-analyses
* Treatment with topotecan or platinum-based single and combination regimens in female patients of any race with cancer of the cervix recurrent after radiotherapy or stage IVB disease

Exclusion Criteria:

* None

Primary outcomes:
measure: Survival
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00898885: Analysis of the Clinical and Histological Correlation of Oral Graft-Versus-Host-Disease (GVHD)
Official title: Clinical and Histological Evaluation of Chronic Graft-Versus Host Disease (cGVHD) in Oral Mucosa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Graft-Versus-Host Disease
Keywords: oral manifestations
bone marrow transplantation
adverse effects
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2009-05-12
Enrollment: 41
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients underwent bone marrow transplantation with clinical signs of oral Graft-versus-host Disease

Brief summary: Introduction: Graft-versus-host-disease (GVHD) is the major cause of morbidity and mortality in patients submitted to the Bone Marrow Transplantation (BMT). The oral manifestations can be very debilitating and interfere in the results of medical therapy, leading to systemic complications, committing the prognosis and quality of life of the patient.

The early diagnosis can be done through biopsies of oral mucosa with or without apparent injury clinic. The association between the clinical and histopathological tables of GVHD, especially through the use of recent consensus established in these areas, can bring new benefits to physicians.

Objective: This study aims to apply and compare the two classifications histological to GVHD, Horn (1995) and Consensus (2006) in specimens obtained from clinical oral lesions suggestive of GVHD; correlate them with clinical classification according Akpek (2001) and with the survival of the patients.

Detailed description: Methods: For this study we analyzed histological samples of oral mucosa of 10 patients with clinical diagnosis of GVHD, which have areas of epithelium, and salivary gland. The histopathological aspects were observed by the author of this work and his advisor, so blinded by applying the criteria for Horn and the Consensus. We consistency between the two classifications obtained and histological correlation with the clinical classification of GVHD (Akpek, 2001) and the curve of survival.

Eligibility criteria: Inclusion Criteria:

* all patients with clinical signs of oral GVHD that underwent oral biopsy

Exclusion Criteria:

* samples without epithelium or minor salivary glands

Primary outcomes:
measure: The histological classification according Horn showed that in most cases there was presence of GVHD with low degrees of severity; Already classification of the Consensus showed that there were in full presence of GVHD of moderate degree.
timeFrame: during the survey data, and analysis of specimens
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Sao Paulo - Brazil
name: Marina HG Magalhães, DMD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00904085: Post-operative Efficacy and Safety Study
Official title: A Randomized, Double-blind Evaluation of the Analgesic Efficacy and Safety of a Low Dose Oxymorphone Immediate Release in Patients Following Ambulatory Arthroscopic Knee Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post-operative Pain
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-05-19
Enrollment: 122
Sex: ALL
Minimum age (years): 18
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 was to compare the analgesic efficacy of 5 mg oxymorphone IR with placebo in patients with mild to moderate pain following outpatient knee arthroscopy.


Eligibility criteria: Inclusion Criteria:

* Males or females, 18 years of age or older, who have completed outpatient knee arthroscopy
* Have an initial pain intensity score of between 30mm and 70mm on a 100mm Visual Analogue Scale(VAS) and a categorical pain rating scale of none, mild, moderate, or severe,
* Have been informed of the nature of the study and provided written informed consent

Exclusion Criteria:

* Have a positive pregnancy test
* Have received any of the following medications within 24 hours prior to dosing: COX2 inhibitors, Minor Tranquilizers, Muscle relaxants, Antihistamines
* Long-acting oral and parenteral analgesics are prohibited for at least 12 hours prior to receiving study medication.
* Have received any of the following medication within 48 hours prior to dosing: Chronic use of analgesics (opioid or non-opioid including aspirin \[\>325 mg/day\], acetaminophen, and NSAIDs)
* Have received MAOI drugs within 2 weeks prior to dosing
* Not stabilized on the following medications for at least 4 weeks prior to dosing: Tricyclic antidepressant drugs, Serotonin reuptake inhibitors, Amphetamines used for ADHD

Primary outcomes:
measure: Sum of Pain Intensity (SPID) Visual Analog Scale (VAS)
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Endo Pharmaceuticals
name: Sr. Director
role: STUDY_DIRECTOR
References: