louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04848246: Effect of Smoking Cessation on Tuberculosis Treatment Outcomes
Official title: Efficacy of Smoking Cessation Interventions on Tuberculosis Treatment Outcomes Among Newly Diagnosed Pulmonary Tuberculosis Patients; a Single Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis, Pulmonary
Keywords: smoking cessation
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 292
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of three groups, two intervention and one control
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was a Randomized Controlled Trial conducted at Ojha Institute of Chest Diseases, Dow University of Health Sciences, Karachi, among pulmonary tuberculosis patients


Eligibility criteria: Inclusion Criteria:

* pulmonary tuberculosis patients of age 18 years or above
* registered under Directly Observed Treatment Short course (DOTS) at Ojha Institute of Chest Diseases
* reported to have smoked 100 plus cigarettes in past and currently smoking cigarettes

Exclusion Criteria:

* Extra pulmonary tuberculosis
* drug resistant tuberculosis
* pregnancy
* positive history of epilepsy

Primary outcomes:
measure: Percentage of patients completing anti-tuberculosis treatment
timeFrame: six months
Secondary outcomes:
measure: Percentage of participants achieving abstinence from smoking
timeFrame: six months
Other outcomes:
measure: Percentage of patients defaulting anti-tuberculosis treatment.
timeFrame: Six Months
Locations:
city: Karachi
country: Pakistan
facility: Dow University of Health Sciences
state: Sindh
Study officials:
affiliation: Dow University of Health Sciences
name: Muhammad Tahir Rizwan Khan, M.Phil.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00185146: Efficacy and Safety of Pactimibe in Patients With Atherosclerosis
Official title: Effect of Pactimibe on the Progression of Atherosclerosis as Measured by 2-D and 3-D Carotid Ultrasound
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atherosclerosis
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 200
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The effect of pactimibe on the reduction of atherosclerosis in the carotid artery will be assessed using carotid ultrasound


Eligibility criteria: Inclusion Criteria:

* Increased cardiovascular risk (i.e. history of myocardial infarction, stroke, diabetes mellitus, left ventricular hypertrophy)
* Intima-media thickness greater than or equal to 0.8 mm as measured by ultrasonography
* Negative pregnancy test for females

Exclusion Criteria:

* Whole blood donation (greater than or equal to 450 ml) during the last three months before study start
* Unstable angina, congestive heart failure or uncontrolled hypertension
* Renal disease including nephrectomy and/or renal transplant
* Hepatic disease or abnormal liver function parameters
* Drug abuse or alcohol addiction

Primary outcomes:
measure: Efficacy of pactimibe versus placebo on the progression of atherosclerosis
Secondary outcomes:
measure: Safety and tolerability of pactimibe versus placebo in patients with atherosclerosis
Other outcomes:
Locations:
city: Munich
country: Germany
Study officials:
affiliation: IMFORM GmbH
name: P U Witte, MD, PhD, FFPM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01036646: User Performance Evaluation of the INRatio® Prothrombin Time (PT) Monitoring System With a New INRatio Test Strip Designed for Low Sample Volume and Heparin Insensitivity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Anticoagulation
Keywords: Patients on stable OAT therapy for at least 3 months.
Lead sponsor: Abbott RDx Cardiometabolic
Sponsor class: OTHER
First posted: 2009-12-21
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from their primary care clinic.

Brief summary: This multi-center study is designed to evaluate the ability of intended lay users (patients on oral anticoagulation therapy, OAT, or their caregivers) to 1) operate the INRatio Prothrombin Time (PT) Monitoring System utilizing the INRatio test strip newly designed for low sample volume and heparin insensitivity, and 2) obtain accurate results for the quantitative determination of International Normalized Ratio (INR) when self-testing using fingerstick capillary blood. Patients will be trained by their healthcare provider using the instructions for use and product labeling provided. The accuracy of the patient INR results will be assessed by comparison to the INR results obtained by the site's trained healthcare professional using the same INRatio system (from a separate fingerstick collected from the same patient at the point-of-care), and with the INR results obtained on venous plasma obtained from the same patient and analyzed at a central laboratory with the Sysmex CA-560 System INR reference method.


Eligibility criteria: Inclusion Criteria:

* Adults (18 years of age or older);
* Ability to read and speak English;
* Subjects on stable oral anticoagulation therapy with warfarin (at least 3 months);
* Target INR interval between 2.0 and 4.5
* Willing and able to provide written informed consent and comply with study procedures;

Exclusion Criteria:

* Hematocrit less than 25 or greater than 55%
* Lupus or antiphospholipid syndrome (APS)
* Already participated in this study
* A current INRatio PT Monitoring System User / Patient Self Tester

Primary outcomes:
measure: Operate the INRatio Prothrombin Time (PT) Monitoring System utilizing the INRatio test strip newly designed for low sample volume and heparin insensitivity.
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda VA Hospital
state: California
city: Sacramento
country: United States
facility: UC Davis Healthcare System
state: California
city: San Diego
country: United States
facility: San Diego Cardiac Center
state: California
city: Aurora
country: United States
facility: Fox Valley Cardiology
state: Illinois
Study officials:
References:
Clinical trial NCT00478569: Adherence to PTH(1-84) Treatment (FP-002-IM)
Official title: Adherence to PTH(1-84) Treatment in Europe. A Non-interventional Cohort Study Collecting Safety Information and Examining Reasons and Predictors for Adherence to PTH(1-84) Treatment in Usual Clinical Settings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clinical Use of PTH(1-84)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2007-05-25
Enrollment: 1179
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Postmenopausal women with osteoporosis and a high risk of fractures prescribed PTH(1-84) in a normal clinical setting.

Brief summary: The primary objective is:

1) to describe adherence (and the main factors influencing adherence) to PTH(1-84) treatment when prescribed in a normal clinical setting.

The secondary objectives are:

1. to describe the demographics and clinical characteristics of the patients that in a normal clinical setting are started on a treatment regimen with PTH(1-84)
2. to describe (using available data) the long term treatment effectiveness during the 24 months following initiation of PTH(1-84) treatment in a normal clinical setting
3. to monitor safety for 24 months following initiation of PTH(1-84) treatment in a patient in a normal clinical setting.


Eligibility criteria: Inclusion Criteria:

* According to the current Summary of Product Characteristics (SmPC)
* PTH(1-84) treatment initiated within one month preceding enrolment
* The patient's written informed consent to direct access and data processing must be obtained.

Exclusion Criteria:

* According to the current SmPC
* The patient cannot participate in a clinical trial with PTH (all other trials allowed).

Primary outcomes:
measure: Number of Participants Who Discontinued Before 6 Months of Treatment
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment
timeFrame: From enrollment to 3, 12, 18, and 24 months
measure: Duration of Treatment
timeFrame: 24 months
measure: Treatment Compliance by Visit
timeFrame: From enrollment to 3, 6, 12, 18, and 24 months
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Nycomed
Study officials:
affiliation: Takeda
name: Medical Director, Clinical Science
role: STUDY_DIRECTOR
References:
Clinical trial NCT04265469: Mobile Application For Educating Diabetics About Foot Care
Official title: The Effect of Mobile Application in Foot Care of Type 2 Diabetes Patients: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot, Mobile Application, Patient Education
Keywords: Diabetic foot, mobile application, patient education
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 130
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: PREVENTION

Brief summary: Purpose: Our aim was to develop a training program on the mobile application and to assess the effect of this training on the participants' knowledge about foot care, their self-efficacy and their behavior levels.

Detailed description: The universe of this randomized controlled study consisted of 130 patients who had presented to a training and research hospital in Istanbul. The data were collected during the period March-September 2017 with an Information Form, the Diabetic Foot Knowledge Scale, Diabetic Foot Care Self-efficacy Scale, Foot Self-care Behavior Scale and a Feedback Form on the Mobile Application Training.

Eligibility criteria: Inclusion Criteria:

* diagnosed as a Type 2 diabetic according to ADA criteria at least six months prior to the study,
* being 18 years of age and over,
* being literate and fluent in Turkish,
* not having an active foot ulcer,
* owning and being able to operate a smart phone,
* not having any communication or mental problems,
* consenting to participating in the research.

Exclusion Criteria:

* Patients with advanced retinopathy and those wishing to withdraw from the research were excluded from the study.

Primary outcomes:
measure: their self-efficacy
timeFrame: change from baseline self efficiancy at week 4.
measure: Diabetes Foot Knowledge
timeFrame: change from baseline Diabetes Foot Knowledge at week 4.
measure: Foot Self-care Behavior
timeFrame: change from baseline Foot Self-care Behavior at week 4.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05243069: Head and Neck Cancer Patient Symptom and Oncologic Outcomes
Official title: Head and Neck Cancer Patient Symptom and Oncologic Outcomes as a Function of Head and Neck Volume Changes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lymphedema of the Head and Neck
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2022-02-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This trial investigates a new approach using a mobile three-dimensional (3D) scanning application for volumetric measurement of the head and neck region in patients with head and neck lymphedema. Lymphedema is the buildup of extra lymph fluid in tissues that causes swelling. Accurate volumetric measurements of swelling are crucial to the diagnosis of lymphedema and to monitoring response to therapy and disease progression over time. A mobile 3D surface scanning application may help doctors measure and analyze swelling in patients with head and neck lymphedema.

Detailed description: PRIMARY OBJECTIVES:

I. To develop a specialized and mobile 3D surface scanning application to assess and monitor head and neck lymphedema.

II. To confirm optimal positioning when volumetrically assessing head and neck lymphedema using 3D technologies as consistent with standard plastic surgery departmental protocol.

III. To quantify and serially track changes in head and neck lymphedema in patients with pathologies and correlate these changes with overall patient well-being and disease progression.

OUTLINE:

Patients undergo 3D scanning of lower head and neck region over 90-120 seconds before surgery and then every 3 months for up to 1 year after surgery.

Eligibility criteria: Inclusion Criteria:

* Patients with pathologies leading to head and neck lymphedema
* Individuals with minimal or no facial hair
* Patients of sound mentation, who are able to execute informed decision-making

Exclusion Criteria:

* Any health conditions or history of non-compliance that affect the study will preclude study participation

Primary outcomes:
measure: Volume of interest between the cutting planes
timeFrame: Up to 24 weeks
measure: Average values of the two repeated scans
timeFrame: Up to 24 weeks
measure: Patient wellbeing/disease progression
timeFrame: Up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Roman Skoracki, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03030469: Electronic Defaults to Reduce Opioid Prescribing in Dentistry Practices
Official title: A Cluster-randomized Trial of Modifying Electronic Health Record Defaults to Reduce the Prescribed Quantity of Opioid Analgesics in Dentistry Practices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Pain
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Albert Einstein College of Medicine
First posted: 2017-01-25
Enrollment: 10000
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 goal of this research is to investigate the impact of changing opioid analgesic prescribing defaults on the quantity of opioids prescribed for acute non-cancer pain in adult dentistry settings. We will change prescribing defaults for select short-acting opioid analgesics including immediate release oxycodone and hydrocodone as well as codeine and tramadol, including their co-formulations with acetaminophen. In a cluster-randomized trial of three Montefiore Medical Center dentistry sites, we will evaluate the impact of this intervention on patient-level outcomes using 18 months of data (6 months pre-intervention and 12 months post-intervention).


Eligibility criteria: Clinical Site Inclusion Criteria:

* Dentistry clinic within Montefiore Medical Center

Patient Inclusion Criteria:

* Received a new opioid analgesic prescription, defined as no opioid analgesic prescription in the preceding 6 months

Exclusion Criteria:

* None

Primary outcomes:
measure: Initial prescription number of pills to dispense
timeFrame: Through study completion (18 months)
Secondary outcomes:
measure: Initial prescription morphine milligram equivalents to dispense
timeFrame: Through study completion (18 months)
measure: Opioid analgesic reorder (y/n)
timeFrame: Within 30 days after the initial prescription
measure: Total opioid analgesic pills to dispense, including re-orders
timeFrame: Within 30 days after the initial prescription
measure: Total morphine milligram equivalents to dispense, including re-orders
timeFrame: Within 30 days after the initial prescription
measure: Outpatient visits
timeFrame: Within 30 days after the index prescription
measure: Emergency department visits
timeFrame: Within 30 days after the initial prescription
measure: Hospitalizations
timeFrame: Within 30 days after the initial prescription
Other outcomes:
Locations:
Study officials:
affiliation: Montefiore Medical Center
name: Marcus Bachhuber, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bachhuber MA, Nash D, Southern WN, Heo M, Berger M, Schepis M, Sugarman OK, Cunningham CO. Reducing Opioid Analgesic Prescribing in Dentistry Through Prescribing Defaults: A Cluster-Randomized Controlled Trial. Pain Med. 2023 Jan 4;24(1):1-10. doi: 10.1093/pm/pnac106.
Clinical trial NCT03499769: Comparison of NOSE and Conventional Methods in Laparoscopic Total Colon Surgery
Official title: Comparison of NOSE and Conventional Methods in Laparoscopic Total Colon Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Incision
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2018-04-17
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Laparoscopic total colectomy (LTC) is an accepted surgical procedure for several colonic pathologies. Additionally, specimen extraction through the natural orifices is an emerging method when combined with the totally laparoscopic procedures. Our observations on natural orifice surgery was promising . In our daily surgical practice, investigators prefer the intracorporeal anastomosis and this study was conducted to compare the specimen extraction sites after LTC. Here investigators aimed to compare the results of conventional and natural orifice specimen extractions (NOSE) after totally LTCs.

Detailed description: compare the patient-selected NOSE method and conventional method in laparoscopic total colon surgery

Eligibility criteria: Inclusion Criteria:

* laparoscopic total colectomy patients

Exclusion Criteria:

* no

Primary outcomes:
measure: Visual Analog Score
timeFrame: 240 days
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Inonu University
Study officials:
affiliation: Inonu Unıversity- general surgery
name: Ersin Gündoğan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00546169: Non-interventional Trial About Treatment of Haemorrhages in Cholecystectomy With TachoSil (TC-027-DE)
Official title: Non-interventional Trial About Treatment of Haemorrhages in Cholecystectomy With TachoSil (TC-027-DE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhage
Keywords: Patients undergoing elective or acute cholecystectomy
Lead sponsor: Nycomed
Sponsor class: INDUSTRY
First posted: 2007-10-18
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: care clinic

Brief summary: * Effectiveness and reliability of TachoSil in cholecystectomy (elective and acute)
* Evaluation of TachoSil in laparoscopic cholecystectomy
* Risk profile of patient under anticoagulant therapy undergoing acute cholecystectomy
* Pharmaco-economic evaluation
* Recording of AE's/SAE's Considering the total number of cholecystectomies in Germany (170.000 cases/y), out of them about 75% laparoscopic and 10.000 conversions totally it seems urgent to record data about usage of TachoSil in such procedures. For the time being TachoSil is applied in about 2% of the gall bladder procedures.

Aim is to evaluate a possible patient and procedure profile where TachoSil is most beneficial.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective or acute cholecystectomy
* The only restrictions of use will be those resulting from the contraindications (see section 4.3 of the Summary of Product Characteristics)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Nycomed
Study officials:
affiliation: Headquaters
name: Nycomed Clinical Trial Operations
role: STUDY_CHAIR
References:
Clinical trial NCT02407769: Late Evening Supplementation With Branched Chain Amino Acids in Liver Transplantation
Official title: Effect of a Late Evening Supplementation With Branched Chain Amino Acids on the Nutritional Status in Patients on the Waiting List for Liver Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Cirrhosis
Keywords: Liver transplantation
Liver cirrhosis
Branched chain amino acids
Late evening supplementation
Nutritional status
Lead sponsor: Universidad de Guanajuato
Sponsor class: OTHER
Collaborators: name: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
First posted: 2015-04-03
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assess the impact in body composition and handgrip strength of the nocturne supplementation by a month with BCAA (Enterex hepatic in patients awaiting liver transplantation)

Detailed description: Clinical trial study was make, data were obtained from people awaiting liver transplantation and with at least a criteria of protein/energy malnutrition (fase angle \< 5.4°, subjective global assessment B or C and/or handgrip strength \< 30 in men and \< 20 in women). The investigators make them body composition assessment (weight, height, body mass index \[BMI\], mean arm circumference \[MAC\], muscle arm area \[MAA\], tricipital skinfold, Dual X ray absorptiometry \[fat mass and fat free mass\]) and handgrip strength at beginning and after 30 days of nocturne supplementation with BCAA and standardized diet (35-40 Kcal, 55% carbohydrates, 25% lipids and 20% proteins).

Eligibility criteria: Inclusion Criteria:

* Patients on waiting list for liver transplantation.
* Diagnosis of undernutrition.

Exclusion Criteria:

* Hepatorrenal syndrome.
* Hepatopulmonar syndrome
* Diabetes
* Overweight

Primary outcomes:
measure: Change in Body Composition
timeFrame: Basal and 30 and 60 days after intervention.
Secondary outcomes:
measure: Change in Mid arm muscle area
timeFrame: Basal and 30 and 60 days after intervention.
measure: Change in Quality of life
timeFrame: Basal and 30 and 60 days after intervention.
measure: Change in Fase angle.
timeFrame: Basal and 30 and 60 days after intervention.
measure: Change in Handgrip strength.
timeFrame: Basal and 30 and 60 days after intervention.
Other outcomes:
Locations:
city: México
country: Mexico
facility: Instituto Nacional de ciencias Médicas y Nutrición Salvador Zubirán
state: DF
Study officials:
affiliation: Universidad de Guanajuato
name: Niko Alain Cruz Sancén
role: PRINCIPAL_INVESTIGATOR
References: