louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01540149: Tel Aviv Sourasky MC Home Monitoring Clinic Registry
Official title: Tel Aviv Sourasky MC Home Monitoring Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Home Monitoring With ICD Patient
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-02-28
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICD or CRTD implanted patient

Brief summary: The purpose of the registry is to assess workload of a Home Monitoring based follow up for Biotronik implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRTD) patients.

Detailed description: EP unit device clinic is a very busy clinic. Every 6 month the patients arrive for device follow up where the device parameters, patient condition and arrhythmic events are being reviewed, and reprogramming of the device (if needed) is done. Average net time of patient's stay in the clinic is between 30-45 minutes.

Patients implanted with the Lumax device family allows for a better automated follow up procedure via remote management (Home Monitoring).

Eligibility criteria: Inclusion Criteria:

* Approved indication for ICD or CRTD.
* Implanted with or replaced with a Biotronik Lumax device.
* Patient is willing and able to sign consent form.
* Willing and able to attend clinic visits and follow up schedule.
* Transmission of more than 80% at 3-month FU.
* Patient older than 18 years.

Exclusion Criteria:

* No indication for ICD or CRTD implant.
* Life expectancy shorter than 12 months.
* Pregnancy.
* Participation in other clinical studies.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Electrophisiology Department
Study officials:
affiliation: Tel Aviv Sourasky MC
name: Aharon Glik, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00669149: Anticoagulant Treatments and Percutaneous Coronary Angioplasty
Official title: Anticoagulant Treatments Evaluation During Percutaneous Coronary Angioplasty in Stable Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: ptca
antiaggregant therapy
anticoagulant therapy
Lead sponsor: Centre Hospitalier de PAU
Sponsor class: OTHER
First posted: 2008-04-29
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether adjunction of intravenous anticoagulant therapy (enoxaparin, HNF, bivalirudin) to antiaggregation with clopidogrel and aspirin improves in-hospital results of percutaneous transluminal coronary angioplasty (ptca) in selected patients.

Detailed description: * Background : We don't know if using IV anticoagulant therapy is necessary for percutaneous coronary angioplasty in stable patients.
* Purpose : to compare efficacy and security of use or not of different anticoagulant treatments during percutaneous coronary angioplasty in patients with double antiaggregant therapy.
* Abstract : In stable patients pretreated with double antiaggregant therapy use of IV anticoagulants has not been yet evaluated during angioplasty. In this prospective randomized trial we want to compare in such patients the efficacy and security of the administration of IV heparin, IV enoxaparin, IV bivalirudin and no use of anticoagulant during coronary angioplasty. We will evaluate in each group ischaemic events (clinic, ECG and biology) and haemorrhagic events (clinic, biology) with a one month follow up.
* Primary outcome: ischaemic events via troponin Ic measurements during 24 hours post procedure.
* Secondary outcomes: haemorrhagic events : clinical and biological evaluation (Hb, Ht, TIMI score)
* Study design : monocentric randomized clinical trial type therapeutic equivalence phase IV.
* Interventions : In patients prepared with therapeutic association (aspirin clopidogrel) comparison between use or no of anticoagulant (IV heparin, IV enoxaparin or IV bivalirudin).
* Number of subjects : 120 per group (total of 480).
* Statistical analysis : multivariate analysis with logistic regression models : each end point (troponin Ic increase, haemoglobin decrease, ...) will be explicated with treatment group and other covariates (sex, age, creatinine, ...).

Eligibility criteria: Inclusion Criteria:

* stable angina pectoris or silent ischaemia

Exclusion Criteria:

* instable angina or ACS (Acute Coronary Syndrome)

Primary outcomes:
measure: ischaemic events via troponin Ic measurements during 24 hours post procedure
timeFrame: 24 hours
Secondary outcomes:
measure: haemorrhagic events : clinical and biological evaluation
timeFrame: 24 hours
Other outcomes:
Locations:
city: PAU
country: France
facility: Centre Hospitalier de Pau
state: Pyrénées-Atlantiques
Study officials:
affiliation: CH de Pau
name: Nicolas DELARCHE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03165149: Effect of a Topical Ketamine on Acute and Chronic Pain, Dose Finding
Official title: Effect of a Topical Ketamine on Acute and Chronic Post-mastectomy Pain, Dose Finding - Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Breast Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-05-24
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to investigate the effect of addition of different doses of Ketamine locally in acute and chronic post-mastectomy pain after breast cancer surgery and on the probability of developing chronic post-mastectomy pain.


Eligibility criteria: Inclusion Criteria:

- American society of heart association class I-II female patients

* aged 18-60 years
* scheduled for modified radical mastectomy with axillary dissection for breast carcinoma

Exclusion Criteria:

* known allergy to the study drugs
* significant cardiac-
* respiratory-
* renal or hepatic disease

Primary outcomes:
measure: the total amount of morphine consumption
timeFrame: 48 hours
Secondary outcomes:
measure: pain intensity
timeFrame: 48 hours
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: South Egypt Cancer Instuite
Study officials:
References:
Clinical trial NCT00520949: Quadruple Therapy for Triple Therapy Resistant Helicobacter Pylori Infection
Official title: Quadruple Therapy Using Esomeprazole, Colloidal Bismuth Subcitrate, Amoxicillin-Clavulanate, and Furazolidone in Patients Who Failed to Eradicate H. Pylori With Triple Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Treatment of Helicobacter Pylori
Keywords: H.pylori
Triple therapy failure
Quadruple therapy
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2007-08-27
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Triple therapy, a combination of proton pump inhibitor with two antibiotics, is the gold standard for anti-Helicobacter pylori treatment. Usual antibiotics are clarithromycin, and either amoxicillin or one of the nitroimidazoles (metronidazole). However, there is an increasing evidence of H. pylori resistance to classical triple therapy. Another reason for this failure being low patient compliance with treatment. A regimen useful in one geographical area may not be effective or practical in another area. The aim of this study was to eradicate H. pylori infection resistant to triple therapy, establish the efficacy and safety of a 14-day therapeutic regimen to eradicate of H. pylori in patients who have failed with the classical triple therapy (omeprazole, clarithromycin and amoxicillin) given for 14 days.


Eligibility criteria: Inclusion Criteria:

* Informed consent given by the patient
* Patients known to have H. pylori infection diagnosed by histopathology, rapid urease test and urea breath test
* Failure to respond to classical triple regime of amoxicillin 1gram, clarithromycin 500mg and omeprazole 20mg twice a day for 10-14 days as documented by repeat urea breath test done one month after eradication therapy

Exclusion Criteria:

* Evidence of any malignancy, gastric outlet syndrome, history of gastric surgery, chronic liver disease, severe chronic renal failure, or any major co-morbidity.
* known or suspected hypersensitivity to the medication used in the study

Primary outcomes:
measure: Eradication of H. pylori infection resistant to triple therapy.
timeFrame: 6 weeks
Secondary outcomes:
measure: Safety of the quadruple therapy
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University Hospital
state: Sindh
Study officials:
affiliation: Aga Khan University
name: Zaigham Abbas, FACG
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abbas Z, Yakoob J, Abid S, Jafri W, Islam M, Azam Z, Hilal I. Furazolidone, co-amoxiclav, colloidal bismuth subcitrate, and esomeprazole for patients who failed to eradicate Helicobacter pylori with triple therapy. Dig Dis Sci. 2009 Sep;54(9):1953-7. doi: 10.1007/s10620-008-0582-6. Epub 2008 Dec 5.
Clinical trial NCT00745849: Efficacy of Esomeprazole for Non-Allergic Rhinitis: A Double-blind, Placebo Controlled Trial
Official title: Efficacy of Esomeprazole for Non-Allergic Rhinitis: A Double-blind, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vasomotor Rhinitis
Keywords: non-allergic rhinitis, laryngopharyngeal reflux
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2008-09-03
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to see if high dose esomeprazole (40mg bid) was effective in treating non-allergic rhinitis


Eligibility criteria: Inclusion Criteria:

* age between 18-80, symptoms of perennial rhinitis, negative epicutaneous skin testing to a panel of common aeroallergens, and ability to speak English

Exclusion Criteria:

* pregnancy or breast-feeding, evidence of positive skin tests to a common aeroallergen, treatment with a proton pump inhibitor within the month prior to enrollment, treatment with any other anti-reflux therapy within the last month on a daily basis or within the last two weeks on an as needed basis, and other gastrointestinal disorders leading to reflux symptoms

Primary outcomes:
measure: Total Nasal Symptom Scores
timeFrame: Last two weeks of each treatment arm
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Clinical Trials Office, Aston Building, UT Southwestern
state: Texas
Study officials:
affiliation: Department of Allergy and Immunology, UT Southwestern
name: David A Khan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04032249: Implications of Self-weighing During Weight Loss Treatment
Official title: Implications of Self-weighing During Weight Loss Treatment: A Pragmatic 6-month Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight and Obesity
Signs and Symptoms
Behavior, Eating
Keywords: Obesity
Self-weighing
Weight loss
Mobile health
Lead sponsor: Universidad de Córdoba
Sponsor class: OTHER
First posted: 2019-07-25
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aims to analyze the effectiveness of introducing behavioral elements in a weight loss program, in this case, comparing the difference between self-weighing versus not doing so.


Eligibility criteria: Inclusion Criteria:

* Having a IMC \>25,
* Being sedentary and
* Have not been submitted to a restrictive diet in the 6 months preceding this study

Exclusion Criteria:

* Suffered from type 2 diabetes or renal conditions
* Being pregnancy or attempt at pregnancy,
* Undergoing antidepressant pharmacological treatment

Primary outcomes:
measure: Changes from baseline BMI
timeFrame: At baseline (0 years) and followed for 2 years
measure: Changes from baseline Fatty mass
timeFrame: At baseline (0 years) and followed for 2 years
measure: Changes from baseline Free-fatty mass
timeFrame: At baseline (0 years) and followed for 2 years
measure: Changes from baseline Muscular Mass
timeFrame: At baseline (0 years) and followed for 2 years
measure: Changes from baseline Corporal Water
timeFrame: At baseline (0 years) and followed for 2 years
measure: Adherence to dietary pattern will be also measured through personal interview
timeFrame: At baseline (0 years) and followed for 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Universidad de Córdoba
Study officials:
References:
citation: Hernandez-Reyes A, Camara-Martos F, Vidal A, Molina-Luque R, Moreno-Rojas R. Effects of Self-Weighing During Weight Loss Treatment: A 6-Month Randomized Controlled Trial. Front Psychol. 2020 Mar 10;11:397. doi: 10.3389/fpsyg.2020.00397. eCollection 2020.
Clinical trial NCT05327049: Evaluation of the Remineralizing Effect of Aloe Vera Versus Diode Laser for Management of Deep Carious Lesions.
Official title: Evaluation of the Remineralizing Effect of Aloe Vera Versus Diode Laser for Management of Deep Carious Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deep Caries
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study will be performed to evaluate:

The remineralizing effect of Aloe Vera versus Diode laser on deep carious dentin after selective caries removal.

Detailed description: This study was conducted on 45 teeth selected from patients according to inclusion and exclusion criteria. They were selected from the dental clinic in faculty of oral and dental medicine for girls, Al-Azhar University. The procedure was explained and written informed consent was obtained from each patient. The possible discomforts, risks, and benefits were fully explained to the patients. Ethical committee approval was obtained.

Protocol of caries removal was Applied Subsequently, the central cariogenic biomasses and superficial part of the necrotic and demineralized dentin was excavated, leaving the leathery dentin layer.

Sample grouping:

The patients were randomly assigned into three main groups according to the material used (15 for each) which were assessed at different time intervals (B1) after three months,(B2) after six months.

A1: cavities will be sealed directly by temporary restorative material (conventional glass ionomer) without any treatment.

A2: cavities will be treated by Diode laser then sealed directly by temporary conventional glass ionomer.

A3: cavities will be treated with Aloe Vera then sealed directly by temporary conventional glass ionomer.

Evaluation of the remineralization effect of Each group will be assessed radiographically immediately at base line (B0), after three months (B1) and six months (B2) to evaluate the dentin remineralization.

Eligibility criteria: Inclusion Criteria:

* Subject must have active deep carious lesion.
* clinical and radiographic examinations of carious lesions.

Exclusion Criteria:

* Teeth with pulpal involvement
* Teeth with abscess
* Teeth with pain or swelling
* Teeth with developmental disorders
* Teeth with adjacent soft tissue lesions
* patients with systemic illness will be excluded

Primary outcomes:
measure: assessment of the remineralizing effect of aloe vera and diode laser on deep caries
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Naşr
country: Egypt
facility: Al-Azhar University
state: Cairo
Study officials:
affiliation: Al-Azhar University
name: Maha Niazy, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04106206: A Safety Study of LY3372689 in Healthy Participants
Official title: Multiple-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of LY3372689
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-09-26
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study is being conducted to determine the safety profile of the study drug after it is given by mouth to healthy participants. Blood tests will be performed to check how much LY3372689 gets into the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive multiple doses of LY3372689 or placebo and will remain in the study for up to eight weeks.


Eligibility criteria: Inclusion Criteria:

* Overtly healthy vasectomized male or a female who cannot get pregnant
* Have a body mass index (BMI) of 18.5 to ≤30 kilograms per square meter (kg/m²)
* Have normal blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study
* Have veins suitable for ease of blood sampling

Exclusion Criteria:

* Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
* Have previously participated or withdrawn from this study
* Smoke more than the equivalent of 10 cigarettes per day and are unwilling to stop smoking for study procedure
* Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate or could interfere with understanding the results of the study

Primary outcomes:
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Observed by the Investigator During Study Drug Administration
timeFrame: Baseline through final follow-up at approximately Day 30
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3372689
timeFrame: Day 1 postdose through Day 15
measure: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3372689
timeFrame: Day 1 postdose through Day 15
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Covance
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05454306: Anser Clavicle Pin for Surgical Management of Midshaft Clavicle Fractures
Official title: The Anser Clavicle Pin for Surgical Management of Midshaft Clavicle Fractures; A U.S. Prospective Case Series
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Clavicle Fracture
Keywords: Clavicle fracture
Clavicle pin
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-07-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goals of this multi-site study are to evaluate the union rate, patient satisfaction, and functional results of the Section 510(K) approved Anser Clavicle Pin in a prospective 50 patient clinical trial in a U.S. population.


Eligibility criteria: Inclusion Criteria:

* Displaced midshaft clavicle fracture Type 2B according to the Robinson Classification
* Skeletally mature
* Surgery performed within 4 weeks after trauma

Exclusion Criteria:

* Not fit for surgery by the anesthesiologist
* Nonunion or previous malunion
* Possible noncompliant patients (eg, alcohol and drug addiction, dementia)
* Additional neurovascular injury
* Pathologic fractures

Primary outcomes:
measure: ASES Score- 2 week
timeFrame: 2 weeks post-operation
measure: ASES Score- 6 week
timeFrame: 6 weeks post-operation
measure: ASES Score- 3 month
timeFrame: 3 months post-operation
measure: ASES Score- 1 year
timeFrame: 1 year post-operation
measure: DASH Score- 2 week
timeFrame: 2 weeks post-operation
measure: DASH Score- 6 week
timeFrame: 6 weeks post-operation
measure: DASH Score- 3 month
timeFrame: 3 months post-operation
measure: DASH Score- 1 year
timeFrame: 1 year post-operation
measure: Radiographic union rate
timeFrame: 1 year post-operation
measure: Clinical union rate
timeFrame: 1 year post-operation
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Jonathan Braman, MD
role: PRINCIPAL_INVESTIGATOR
References: