louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06539156: Prescribing Appropriateness of Thrombo-prophylaxis in Intensive Care Unit of Tertiary Hospital
Official title: Pattern of Prescribing Anticoagulants As DVT Prophylaxis in Intensive Care Unit of Tertiary Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: DVT
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: Egyptian Chinese University
name: Teachers Hospital
First posted: 2024-08-06
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patient records admitted to the ICU with medical or surgical causes treated with anticoagulants for DVT prophylaxis will be collected Patients already on anticoagulant therapy, had history of previous DVT, had End-stage liver disease, admitted with hemorrhage/bleeding or not prescribed DVT prophylaxis will be excluded.

Brief summary: Hospitalized patients are at high risk of venous thromboembolism (VTE), and the appropriate use of thromboprophylaxis can significantly reduce the incidence of VTE in high-risk patients. We investigated the pattern of VTE prophylaxis administration among elderly medical patients and assessed its appropriateness based on the American College of Chest Physicians (ACCP) recommendations. Methods A cross-sectional single-center study will be conducted between July 2024 and December 2024, including hospitalized (\> 48 h), (≥ 60 years), medical and surgical patients, and excluding patients receiving anticoagulant for other reason, having contraindication to thromboprophylaxis, or had VTE diagnosed within 48 h. The Padua and caprine prediction scores will be used to determine the patients' risk for VTE, and thromboprophylaxis use will be assessed against the ACCP recommendations.


Eligibility criteria: Inclusion Criteria:

Patient records

* admitted to the ICU with
* medical or surgical causes
* recieved anticoagulants for DVT prophylaxis

Exclusion Criteria:

* Patients already on anticoagulant therapy,
* had history of previous DVT,
* had End-stage liver disease,
* admitted with hemorrhage/bleeding
* not prescribed DVT prophylaxis

Primary outcomes:
measure: Padua score for medical patients
timeFrame: within 24 hours of ICU admission
measure: Caprini score for surgical patients
timeFrame: within 24 hours of ICU admission
Secondary outcomes:
measure: Bleeding risk assessment
timeFrame: within 24 hours of ICU admission
measure: Direct Anticoagulant cost
timeFrame: within 24 hours of ICU admission till ICU discharge(at least 48 hours)
measure: Adverse drug reaction cost
timeFrame: within 24 hours of ICU admission till ICU discharge (at least 48 hours)
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Teachers Hospital
Study officials:
References:
Clinical trial NCT00002456: Graft-Versus-Host Disease Prevention in Treating Patients Who Are Undergoing Bone Marrow Transplantation
Official title: Postgrafting Methotrexate and Cyclosporine for the Prevention of Graft-Versus-Host Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Graft Versus Host Disease
Leukemia
Lymphoma
Keywords: recurrent childhood acute lymphoblastic leukemia
childhood non-Hodgkin lymphoma
recurrent childhood lymphoblastic lymphoma
recurrent childhood acute myeloid leukemia
recurrent adult acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
relapsing chronic myelogenous leukemia
refractory chronic lymphocytic leukemia
recurrent adult non-Hodgkin lymphoma
graft versus host disease
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
First posted: 2004-04-26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: SUPPORTIVE_CARE

Brief summary: RATIONALE: Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. Sometimes the transplanted cells can make an immune response against normal tissues. Methotrexate and cyclosporine may prevent this from happening.

PURPOSE: Phase III trial to study the effectiveness of treatment with methotrexate and cyclosporine after bone marrow transplantation to provide protection against acute graft-versus-host disease.

Detailed description: OBJECTIVES: I. Determine the efficacy of a combination of methotrexate and cyclosporine, administered after grafting, to prevent the development of acute graft versus host disease (GVHD) in patients undergoing allogeneic bone marrow transplantation.

OUTLINE: Patients receive methotrexate IV on days 1,3,6, and 11. Patients also receive cyclosporine IV twice a day until the patient is eating, then it is administered orally twice a day. Cyclosporine begins on day -1 and continues until day 180. The dose is reduced beginning on day 50.

PROJECTED ACCRUAL: Accrual will continue until further notice.

Eligibility criteria: DISEASE CHARACTERISTICS: Ongoing bone marrow transplantation from HLA-matched siblings or HLA non-identical family members or unrelated donor

PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Life expectancy: Not severely limited by disease other than leukemia Hematopoietic: Not specified Hepatic: No severe hepatic disease Renal: No history of hemorrhagic cystitis No renal disease Cardiovascular No symptomatic cardiac disease Other: No contraindication to the use of cyclosporine or methotrexate

PRIOR CONCURRENT THERAPY: No concurrent experimental treatment on other GVHD prophylaxis studies

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Rainer F. Storb, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00004756: Study of Individualized Instruction Versus Pamphlet in Systemic Lupus Erythematosus
Official title: Randomized Study of Individualized Instruction Versus Pamphlet in Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Lupus Erythematosus
Keywords: arthritis & connective tissue diseases
disease-related problem/condition
educational needs
immunologic disorders and infectious disorders
rare disease
systemic lupus erythematosus
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Virginia Commonwealth University
First posted: 2000-02-25
Enrollment: 150
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: ECT

Brief summary: OBJECTIVES:

I. Evaluate an educational program that has been pretested for cultural appropriateness and literacy requirements in patients with systemic lupus erythematosus (SLE).

II. Assess the impact of this educational program on patients with SLE, with an emphasis on recognizing cardinal symptoms, coping with fatigue, regulating medications, and communicating with the physician.

Detailed description: PROTOCOL OUTLINE:

Patients are randomly assigned to 1 of 2 groups.

One group participates in an educational program administered and coordinated by a health educator. The program includes 1 or 2 educational sessions emphasizing practical advice, each lasting approximately 1.5 hours; social support from a patient-identified management partner; and behavioral reinforcement from health center staff, the patient partner, and written and audio materials.

The control group receives patient educational materials consistent with usual care (pamphlets).

Patients are followed at 6, 12, 24, and 36 months.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

Confirmed systemic lupus erythematosus (SLE) using American College of Rheumatology criteria

Recruitment from the Medical College of Virginia SLE registry

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Virginia Commonwealth University
name: W. Neal Roberts
role: STUDY_CHAIR
References:
Clinical trial NCT01020656: Anticoagulant and Antiplatelet Agents in Patients Undergoing Vitreoretinal Surgery
Official title: Maintenance of Anticoagulant and Antiplatelet Agents for Patients Undergoing Vitreoretinal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Detachment
Keywords: anticoagulant agents
antiplatelet agents
vitreoretinal surgery
Patients suffered from retinal detachment
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2009-11-25
Enrollment: 206
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: We analyzed the chart of 239 eyes (206 patients) which underwent posterior segment surgery with peribulbar anesthesia.

Brief summary: Purpose: To establish the prevalence of anticoagulant, aspirin, and clopidogrel use in patients undergoing vitreoretinal surgery, and to compare the outcome of peribulbar anesthesia between users and non-users.


Eligibility criteria: Inclusion Criteria:

* Take or no anticoagulant treatment before surgery,
* Vitreoretinal surgery

Exclusion Criteria:none

* No surgery
* Anesthetic complication

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Ophthalmology Unit CHU Dijon
state: Burgundy
Study officials:
References:
Clinical trial NCT00317356: A Dose-finding Study of OPC-6535 in Patients With Active Ulcerative Colitis
Official title: A Dose-finding Study of OPC-6535 in Patients With Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Colitis, Ulcerative
Keywords: OPC-6535
ulcerative colitis
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2006-04-24
Enrollment: 43
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: The purpose of this study is to examine the safety and efficacy of OPC-6535 (tetomilast) and to determine its optimal dose by once-daily oral administration at 0, 12.5, 25, or 50 mg for 8 weeks in combination with a fixed oral dose of 5-aminosalicylic acid (5-ASA) in patients with active ulcerative colitis.


Eligibility criteria: Inclusion Criteria:

* Patients with active ulcerative colitis
* Patients who have been receiving an oral 5-ASA formulation at a fixed regimen and at a fixed dose
* Either inpatient or outpatient

Exclusion Criteria:

* Patients who have a history of intestinal resection (other than appendiceal resection)
* Patients who have a complication of malignant tumor
* Female patients who are pregnant, lactating, or possibly pregnant, or who wish to become pregnant during the study period

Primary outcomes:
measure: Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100) After 8 Weeks of Study Drug Administration
timeFrame: Weeks 4 and 8
Secondary outcomes:
measure: Remission Rate (Number of Subjects Showing Remission/Number of Subjects Evaluated x 100) After 4 and 8 Weeks of Study Drug Administration
timeFrame: Weeks 4 and 8
measure: Mean Change From the Baseline in Total DAI Score After 4 and 8 Weeks of Study Drug Administration
timeFrame: Baseline, Weeks 4 and 8
measure: Mean Change From the Baseline in DAI Subscores After 4 and 8 Weeks of Study Drug Administration
timeFrame: Baseline, Weeks 4 and 8
measure: Mean Change From the Baseline in Total Clinical Activity Index (CAI) Score After 2, 4, and 8 Weeks of Study Drug Administration
timeFrame: Baseline, Weeks 2, 4 and 8
measure: Mean Change From the Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score After 8 Weeks of Study Drug Administration
timeFrame: Baseline and Week 8
measure: Mean Change From the Baseline in IBDQ Subscale Scores After 8 Weeks of Study Drug Administration
timeFrame: Baseline and Week 8
measure: Clinical Improvement Rate After 4 Weeks of Study Drug Administration
timeFrame: Week 4
Other outcomes:
Locations:
city: Chubu Region
country: Japan
city: Chugoku Region
country: Japan
city: Hokkaido region
country: Japan
city: Kanto Region
country: Japan
city: Kinki Region
country: Japan
city: Kyushu Region
country: Japan
city: Shikoku Region
country: Japan
city: Touhoku Region
country: Japan
Study officials:
affiliation: Division of New Product Evaluation and Development
name: Katsuhisa Saito
role: STUDY_DIRECTOR
References:
Clinical trial NCT05202756: Examining Feasibility, Acceptability, and Sustainability of a Novel Personalized Smartphone Intervention for Suicide - Randomized Trial
Official title: Examining Feasibility, Acceptability, and Sustainability of a Novel Personalized Smartphone Intervention for Suicide
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicide and Self-harm
Suicide
Suicide, Attempted
Suicidal Ideation
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Brown University
First posted: 2022-01-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of the present study is leverage existing infrastructure to develop novel technological features for a novel personalized smartphone intervention system, called the Mobile Application to Prevent Suicide (MAPS), and to establish feasibility, acceptability, safety, and estimate key parameters for primary outcomes (i.e., suicidal ideation and behavior; re-hospitalization), and target mechanisms.


Eligibility criteria: Inclusion Criteria:

* Presence of suicidal ideation and/or suicidal behavior in the past month
* Between the ages of 18 and 70
* Able to read, write, and understand English well enough to complete study procedures
* Owns a smartphone

Exclusion Criteria:

* Current psychotic or manic symptoms severe enough to interfere with completion of study procedures

Primary outcomes:
measure: Patient Satisfaction
timeFrame: 1 month
measure: Acceptability of Research (Recruitment)
timeFrame: Baseline
measure: Acceptability of Research (Dropout)
timeFrame: 6 months
measure: Acceptability of Research Procedures
timeFrame: 1 month
measure: Acceptability of MAPS Intervention
timeFrame: 1 month
measure: Satisfaction with MAPS Intervention
timeFrame: 4 weeks
measure: Ecological Momentary Assessment (EMA) Adherence
timeFrame: 4 weeks
measure: Suicidal Ideation and Behavior
timeFrame: 6 months
measure: Rehospitalization
timeFrame: 6 months
measure: Emergency Department Visits
timeFrame: 6 months
Secondary outcomes:
measure: Use of MAPS Intervention-delivered Coping Strategies (target mechanism)
timeFrame: 4 weeks
measure: Reduction of Negative Affect (target mechanism)
timeFrame: 4 weeks
measure: Self-Efficacy (target mechanism)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
References:
Clinical trial NCT06519656: Efficacy of Mazdutide for Treating PCOS
Official title: A Clinical Efficacy Study of Mazdutide in the Treatment of Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn the efficacy of Mazdutide in treating obese female adults diagnosed with polycystic ovary syndrome (PCOS). The main question it aims to answer is: Does Mazdutide lower the free androgen index (FAI) in obese female adults with PCOS? Participants will take Mazdutide once every week for 24 weeks and visit the clinic once every 4 weeks for checkups and tests.


Eligibility criteria: Inclusion Criteria:

* BMI≥28kg/M2
* No plan for pregnancy in the coming 8 months after enrollment
* Patients should meet at least two of the three criteria according to the 2023 international evidence-based guideline for PCOS :

  1. Irregular cycles and ovulatory dysfunction: \< 21 or \> 35 days or \< 8 cycles per year; \> 90 days for any one cycle
  2. Polycystic ovaries: ≥20 follicles in at least one of two ovaries (diameter\<10mm), confirmed by ultrasound
  3. Biochemical hyperandrogenism: total testosterone\>1.67 nmol/L or clinical hyperandrogenism: modified Ferriman Gallwey score (mFG)\>4

Exclusion Criteria:

* Previous history of acute or chronic pancreatitis or pancreatic injury
* Previous history or family history of medullary thyroid cancer, multiple endocrine neoplasia type 2a or 2b
* Severe hypertriglyceridemia (TG\>5mmol/L)
* Type 1 or type 2 diabetes mellitus
* Other endocrine diseases that can cause secondary PCOS, including but not limited to: 21 hydroxylase deficiency, prolactinoma, hypothyroidism, Cushing's syndrome, etc
* Pregnancy or breast-feeding
* Patients with other serious diseases affecting heart, liver, kidney, or other major organs
* Patients with any type of cancer

Primary outcomes:
measure: Free Androgen Index (FAI)
timeFrame: 24 weeks
Secondary outcomes:
measure: Times of regular menses
timeFrame: 24 weeks
measure: Number of immature follicles
timeFrame: 24 weeks
measure: Bilateral ovary volume
timeFrame: 24 weeks
measure: Serum anti-Mullerian hormone (AMH)
timeFrame: 24 weeks
measure: HOMA insulin resistance index (HOMA-IR)
timeFrame: 24 weeks
measure: HbA1c
timeFrame: 24 weeks
measure: body mass index (BMI)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
Study officials:
affiliation: Fudan University
name: XI DONG, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00901056: Extracorporeal Shock Wave Therapy for the Treatment of Erectile Dysfunction
Official title: Feasibility Study to Investigate the Effect of Low Intensity Shockwaves on Patients With Erectile Dysfunction Resulted From Vascular Origin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Erectile Dysfunction
Keywords: ED
Erectile Dysfunction
Erectile dysfunction treated with PDE-5 inhibitors
Lead sponsor: Medispec
Sponsor class: INDUSTRY
Collaborators: name: Rambam Health Care Campus
First posted: 2009-05-13
Enrollment: 20
Sex: MALE
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: Low intensity shockwaves have been proven in animal studies to induce local growth of new blood vessels from existing ones.

The hypothesis of this study is that shockwave therapy could improve the symptoms of patients with erectile dysfunction resulted from a vascular origin and respond to PDE-5 inhibitors.

Detailed description: Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered to the penile tissue. Shockwaves are created by a special generator and are focused using a specially designed shockwave applicator apparatus. The shockwaves are delivered trough the applicator covering the corpora cavernosa of the penis.

Eligibility criteria: Inclusion Criteria:

* ED of more than 6 months
* At least 50% unsuccessful to attempt sexual intercourse for 4 times at 4 different days
* Positive response to PDE-5 inhibitors
* IIEF-5 domain score of 12-20 denoting mild to severe ED
* Non-Neurological pathology
* Stable heterosexual relationship for more than 3 months

Exclusion Criteria:

* NPT - normal/flat
* Prior prostatectomy surgery
* Any cause of ED other than vascular related
* Any unstable medical, psychiatric, spinal cord injury, penile anatomical abnormalities
* Clinically significant chronic hematological disease
* Cardiovascular conditions that prevent sexual activity
* History of heart attack, stroke or life-threatening arrhythmia within the prior 6 months.
* Cancer within the past 5 years.
* Anti-androgens, oral or injectable androgens
* Use of any treatment for ED within 7 days of screening including oral medications, vacuum devices, constrictive devices, injections or urethral suppositories

Primary outcomes:
measure: IIEF score
timeFrame: 3 months
Secondary outcomes:
measure: Rigid Score (RS)
timeFrame: 3 months
measure: Quality of Erection Questionnaire (QEQ)
timeFrame: 3 months
measure: Self-Esteem And Relationship Questionnaire (SEAR)
timeFrame: 3 months
measure: Erectile Dysfunction Inventory of Treatment Satisfaction (EDIT)
timeFrame: 3 months
measure: Side Effects
timeFrame: 3 months
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
affiliation: Rambam Health Care Campus
name: Yoram Vardi, Professor
role: PRINCIPAL_INVESTIGATOR
References: