louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00789074: Use of Varenicline for 4-weeks Prior to Quitting
Official title: Effects of an Extended Period of Varenicline Use Prior to Quitting Smoking on Post-quitting Urges to Smoke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tobacco Dependence
Smoking Cessation
Keywords: Smoking cessation
Tobacco dependence
Varenicline
Preloading
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
First posted: 2008-11-11
Enrollment: 101
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: Varenicline (Champix) is a relatively new medicine that is effective in helping people to quit smoking. It is normally started 1-week before stopping smoking and used for up to 12-24 weeks. We are trying to find out if using varenicline for an extended time (4-weeks) before stopping smoking is better than the standard 1-week of use prior to stopping.

The study will recruit 100 smokers who want to stop. They will be randomly allocated to receive varenicline(4-weeks) or placebo (3-weeks followed by 1-week of active treatment as indicated by standard prescribing practice), followed by a 12-week open label treatment period where all participants will receive varenicline.


Eligibility criteria: Inclusion Criteria:

* Smokers seeking treatment
* Aged 18 and over
* Consenting to take part in the trial

Exclusion Criteria:

* Pregnant or breastfeeding
* End-stage renal disease
* Used varenicline in the past 6 months
* Unable to fill in questionnaires in English
* Current psychiatric illness
* Current serious illness including uncontrolled hypertension and recent cardiac event
* Sensitivity to varenicline currently enrolled in other research projects.

Primary outcomes:
measure: Rating of Urges to Smoke 24 Hours and One Week After the Target Quit Date Assessed by Mood and Physical Symptoms Scale
timeFrame: 24 hours and 7 days after quit date (week 4)
Secondary outcomes:
measure: Change in Pre-quit End-expired Carbon Monoxide Reading (CO)
timeFrame: Baseline - week 8
measure: Change in Pre-quit Cotinine Levels
timeFrame: Weeks 1-4 (the first 4-weeks after first medication dose)
measure: Change in Pre-quit Ratings of Cigarette Satisfaction
timeFrame: Baseline - week 4
measure: Change in Pre-quit Cigarette Consumption
timeFrame: Baseline - week 4
measure: Change in MPSS Scores of Urges to Smoke and Cigarette Withdrawal Symptoms Throughout the First Four Weeks of Abstinence
timeFrame: Week 4 - 8
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Tobacco Dependence Research and Treatment Unit
Study officials:
affiliation: Queen Mary University of London
name: Al-Rehan A A Dhanji, MB BS BSc MRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hajek P, McRobbie HJ, Myers KE, Stapleton J, Dhanji AR. Use of varenicline for 4 weeks before quitting smoking: decrease in ad lib smoking and increase in smoking cessation rates. Arch Intern Med. 2011 Apr 25;171(8):770-7. doi: 10.1001/archinternmed.2011.138.
Clinical trial NCT02577874: A Comparison of European and Chinese Blood Sugar Responses
Official title: A Comparison of European and Chinese Blood Sugar Responses
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes
Lead sponsor: Small Changes
Sponsor class: OTHER
Collaborators: name: Sheffield Hallam University
First posted: 2015-10-16
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Health adults, male and female between the ages of 19 and 59

Brief summary: This study is designed to compare the responses to an oral glucose challenge between people of European and Chinese heritage (essential participants in the European arm must have tow European parents and likewise for the Chinese participants).

Detailed description: 100 participants (50 European and 50 Chinese) will attend a lab after an overnight fast and have a capillary finger-prick blood test to assess fasted blood glucose levels and then consume a 50 gram glucose solution. Blood test will be repeated at 15, 30, 45, 60, 90 and 120 minutes post consumption of the glucose solution. This test will be repeated on a spate occasion at least a week later than the first test. Participants will only take part in the experiment after singing informed consent and agreeing to take part in the study and after a medical screening questionnaire assessing that they are non-diabetic or haemophiliac or have blood born infections.

Eligibility criteria: Inclusion Criteria:

* European ethnicity
* Chinese ethnicity
* age 19-59 years

Exclusion Criteria:

* diabetics
* serious blood born infection
* haemophilia

Primary outcomes:
measure: Blood sugar response measured by 7 finger prick blood samples
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Hallam Univeristy Food and Nutrition laboratory
state: South Yorkshire
Study officials:
References:
Clinical trial NCT06980974: Acceptance and Commitment Therapy for Chemsex
Official title: Quasi-Randomized Controlled Trial of Acceptance and Commitment Therapy for Chemsex
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chemsex
Keywords: chemsex
ACT
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2025-05-20
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Quasi-randomized control trial of acceptance and commitment therapy (ACT) for chemsex.

Detailed description: Intervention will entail a prescreening, intake session, 16 therapy sessions, and a six-month follow-up. Each session will be 45-55 minutes long. Participants in ACT-for-chemsex will be compared to participants in a treatment as usual condition.

Eligibility criteria: Inclusion Criteria:

* Male
* age 18-65
* access to internet capable smart device
* documentation of Alabama residence
* access to a private area to attend tele ACT-for-chemsex sessions
* self-reported chemsex within six-months of intake
* English fluency.

Exclusion Criteria:

* Psychotic disorder
* bipolar disorder
* eating disorder
* major neurocognitive disorder diagnosis
* self-harm or suicide attempt within 12 months of screener
* suicide plan/intention at time of screening
* ongoing treatment for a complex medical comorbidity (e.g., in patient cancer treatment)
* current enrollment in an individual ACT-based psychotherapy intervention.

Primary outcomes:
measure: Chemsex frequency
timeFrame: Baseline, 16 week post-treatment, six month follow-up
Secondary outcomes:
measure: Modified NIDA ASSIST
timeFrame: Baseline, 16 week post-treatment, six month follow-up
measure: Sexual Health History
timeFrame: Baseline
measure: Center for epidemiologic studies depression scale
timeFrame: Baseline, 16 week post-treatment, six month follow-up, every two weeks.
measure: generalized anxiety disorder-7
timeFrame: Baseline, 16 week post-treatment, six month follow-up, every two weeks
measure: Experiential Avoidance Rating Scale
timeFrame: Baseline, 16 week post-treatment, six month follow-up
measure: PSY Flex
timeFrame: Through study completion, an average of one a week"
measure: Patient Checklist-5
timeFrame: Baseline, 16 week post-treatment, six month follow-up
measure: Quality of Life Scale
timeFrame: Baseline, 16 week post-treatment, six month follow-up
measure: Multidimensional Psychological Flexibility Inventory
timeFrame: Baseline, 16 week post-treatment, six month follow-up
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References:
Clinical trial NCT03779074: Comparing the Efficacy of Hybrid, High-dose Dual and Bismuth Quadruple Therapies
Official title: Efficacies of Hybrid, High-dose Dual and Bismuth Quadruple Therapies for the First-line Anti-H Pylori Treatment and Tetracycline-levofloxacin Quadruple Therapy for the Second-line Anti-H Pylori Treatment - a Multicentre Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori
Eradication rate
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 918
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Both hybrid and high-dose dual therapies developed by the scholars from Taiwan can achieve a high eradication rate for clarithromycin-resistant strains, and have a great potential to replace bismuth quadruple therapy in the treatment of H. pylori infection.

Detailed description: Bismuth quadruple therapy has been recommended as a choice of the first-line treatment for H. pylori infection in several important international consensuses. However, it is associated with a high frequency of adverse events. Both hybrid and high-dose dual therapies developed by the scholars from Taiwan can achieve a high eradication rate for clarithromycin-resistant strains, and have a great potential to replace bismuth quadruple therapy in the treatment of H. pylori infection. In the second-line treatment, tetracycline-levofloxacin quadruple therapy developed by our study group can achieve a higher eradication rate than levofloxacin triple therapy for salvage treatment of hybrid therapy. However, whether the new therapy can be a promising rescue treatment for bismuth quadruple or high-dose dual therapy remains unanswered.

Eligibility criteria: Inclusion Criteria:

* Consecutive H pylori-infected outpatients, at least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis

Exclusion Criteria:

* previous H pylori-eradication therapy
* ingestion of antibiotics or bismuth within the prior 4 weeks
* patients with allergic history to the medications used
* patients with previous gastric surgery
* the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)
* pregnant women

Primary outcomes:
measure: Number of Participants in Which H. Pylori Was Eradicated
timeFrame: sixth week after the end of anti- H. pylori therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
Study officials:
affiliation: Kaohsiung Veterans General Hospital.
name: Ping-I Hsu, Bachelor
role: STUDY_CHAIR
References:
Clinical trial NCT00504673: Comparison of Insulin Detemir Versus Insulin NPH on Weight Change in Overweight and Obese With Type 2 Diabetes
Official title: Comparison of the Effect of Insulin Detemir Versus Insulin NPH Both With Insulin Aspart on Weight Change in Overweight and Obese Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2007-07-20
Enrollment: 277
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: This trial is conducted in Europe. The purpose of the trial is to investigate the effect of insulin detemir on weight change in overweight and obese patients with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* HbA1c: 7.5-11.0%
* BMI: 25-40 kg/m2

Exclusion Criteria:

* Treatment with any OAD (Oral Antidiabetic Drugs) except metformin

Primary outcomes:
measure: Body weight loss
timeFrame: after 26 weeks of treatment
Secondary outcomes:
measure: HbA1c
measure: Incidence of hypoglycaemia
Other outcomes:
Locations:
city: La Coruña
country: Spain
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.
citation: Fajardo Montanana C, Hernandez Herrero C, Rivas Fernandez M. Less weight gain and hypoglycaemia with once-daily insulin detemir than NPH insulin in intensification of insulin therapy in overweight Type 2 diabetes patients: the PREDICTIVE BMI clinical trial. Diabet Med. 2008 Aug;25(8):916-23. doi: 10.1111/j.1464-5491.2008.02483.x.
Clinical trial NCT00751673: TESS Shoulder Arthroplasty Data Collection
Official title: A Prospective, Multicentre Study Evaluating the Clinical Performance of the T.E.S.S Anatomic and Reverse Shoulder Prostheses
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Arthritis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
Collaborators: name: Biomet France SARL
First posted: 2008-09-12
Enrollment: 600
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: Consecutive series of patients received TESS prostheses

Brief summary: This observational study intends to collect efficacy and safety data on TESS shoulder system

Detailed description: The T.E.S.S.® shoulder system has been developed to provide a complete solution for all the indications for Shoulder Arthroplasty, Arthritis, Rotator Cuff Arthropathy, Proximal Humeral Fracture, minimising bone resection and restoring the natural anatomy of the patient.

Eligibility criteria: Inclusion Criteria:

* A pre-operative level of pain and function the same as for conventional joint replacement
* A likelihood of obtaining relief of pain and improved function
* Full skeletal maturity
* Ability to follow instructions
* Good general health for age
* Willing to return for follow-up evaluations

Exclusion Criteria:

* Glenohumeral joint infection, osteomyelitis
* Neuro-muscular complications
* Inability to co-operate with and complete the study

Primary outcomes:
measure: Change in Constant Murley Score
timeFrame: 6 months, 1 year, 2 year, 3 year, 4 year, 5 year, 7 year and 10 year
measure: Change in Oxford Score
timeFrame: 6 months, 1 year, 2 year, 3 year, 4 year, 5 year, 7 year and 10 year
Secondary outcomes:
measure: Complications
timeFrame: Any time
measure: Patient Satisfaction
timeFrame: 6 months, 1 year, 2 year, 3 year, 4 year, 5 year, 7 year and 10 year
Other outcomes:
Locations:
city: Schilde
country: Belgium
facility: De Dreef Van Zonnebos 13
city: Annecy
country: France
facility: Clinique Générale
city: Berck
country: France
facility: Institut Calot
city: Bruges
country: France
facility: Polyclinique Jean Villar
city: Chambery
country: France
facility: Clinique St Joseph
city: Dax
country: France
facility: Centre Hospitalier Général
city: Maxeville
country: France
facility: Clinique Chirurgicale Orthopédique A.D.R.
city: Montpellier
country: France
facility: Clinique St Jean
city: Paris
country: France
facility: IRCOS
city: Pessac
country: France
facility: Clinique St Martin
city: Saint Herblain
country: France
facility: Polyclinique de l'Atlantique
city: St Etienne
country: France
facility: Clinique Mutualiste
city: St Laurent du Var
country: France
facility: Institut A. Tzanck
Study officials:
affiliation: Clinique Mutualiste (Saint Etienne)
name: Laurent BEGUIN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01042873: The Hemodynamic Response to Prolonged Dobutamine Infusion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Healthy
Heart Failure
Keywords: Desensitization
beta adrenergic receptors
Healthy subjects
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2010-01-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: A decrease in the response of beta 1 adrenergic receptors to agonists (desensitization) is thought to play a major role in the pathogenesis of diseases such as congestive heart failure. However, currently, there is no in vivo model that will enable us to measure desensitization of the hemodynamic responses to beta 1 adrenergic receptors in vivo.

Our hypothesis is that constant 3 hours intravenous infusion of the selective beta1 adrenergic receptor agonist dobutamine will result in gradual decline in hemodynamic responses to dobutamine over time.


Eligibility criteria: Inclusion Criteria:

* healthy subjects

Exclusion Criteria:

* consumption of any medications during the 2 weeks prior to the study
* history of chest pain or tachycardia

Primary outcomes:
measure: Heart rate
timeFrame: 3 hours
Secondary outcomes:
measure: Systolic blood pressure
timeFrame: 3 hours
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah University Hospital
Study officials:
References:
citation: Bruck H, Leineweber K, Temme T, Weber M, Heusch G, Philipp T, Brodde OE. The Arg389Gly beta1-adrenoceptor polymorphism and catecholamine effects on plasma-renin activity. J Am Coll Cardiol. 2005 Dec 6;46(11):2111-5. doi: 10.1016/j.jacc.2005.08.041. Epub 2005 Nov 4.
Clinical trial NCT03096873: Combined Resistance and Aerobic Exercise Training on Obesity in Adolescent Girls
Official title: Effectiveness of Combined Resistance and Aerobic Exercise Training on Obesity in Adolescent Girls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Pusan National University
Sponsor class: OTHER
Collaborators: name: Dong-Eui University
First posted: 2017-03-30
Enrollment: 40
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of the study was to observe therapeutic effects of combined resistance and aerobic exercise training (CRAE) on hyperinsulemia in obese adolescent girls. Forty obese adolescent girls (14±1 years) participated in this study. The participants were randomly separated into two groups; no-exercise group (n=20) and exercise group (n=20). The exercise group performed 12 weeks of CRAE.


Eligibility criteria: Inclusion Criteria:

* Obese with Hyperinsulinemia
* Obese with Abdominal obesity

Exclusion Criteria:

* Hypertension
* Pregnancy
* Chronic diseases
* Weight loss diet within the last 6 months

Primary outcomes:
measure: Height in Meters
timeFrame: 12 weeks
measure: Weight in Kilograms
timeFrame: 12 weeks
measure: BMI in Weight (Kilograms)/Height (Meters)^2
timeFrame: 12 weeks
measure: Body Fat in Percents
timeFrame: 12 weeks
measure: Lean Body Mass in Percents
timeFrame: 12 weeks
measure: Waist Circumference in Centimeters
timeFrame: 12 weeks
measure: Glucose Levels in Millimole Per Liter
timeFrame: 12 weeks
measure: Insulin Levels in Micro Unit Per Milliliter
timeFrame: 12 weeks
measure: Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
timeFrame: 12 weeks
measure: Leptin Levels in Nano Grams Per Milliliter
timeFrame: 12 weeks
measure: Adiponectin Levels in Micro Grams Per Milliliter
timeFrame: 12 weeks
Secondary outcomes:
measure: Volume of Maximal Oxygen Consumption (VO2max)
timeFrame: 12 weeks
measure: Arterial Stiffness
timeFrame: 12 weeks
measure: Systolic Blood Pressure
timeFrame: 12 weeks
measure: Diastolic Blood Pressure
timeFrame: 12 weeks
measure: Maximal Heart Rate
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01305473: A Retrospective Study With Prospective Follow-Up of Laparoscopic Ventral Hernia Repair Utilizing the Bard Sepramesh IP Composite
Official title: A Single Arm, Single-Center, Retrospective Study With Prospective Follow-Up of Laparoscopic Ventral Hernia Repair Utilizing the Bard Sepramesh IP Composite
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hernia
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2011-02-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have been treated with Sepramesh at least 12 months before starting in this study.

Brief summary: This study will enroll subjects who underwent a laparoscopic ventral hernia repair utilizing Sepramesh at least 12 months before starting in this study.

The consented subjects' medical records will be reviewed for evidence of any risk factors of hernia recurrence, procedure time, complications and any documented recurrences. The subjects will be asked to undergo a physical exam to rule out any recurrences that were not documented in the medical records.


Eligibility criteria: Inclusion Criteria:

* Have undergone a laparoscopic ventral repair utilizing Sepramesh at least 12 months before starting in this study.
* Have signed an Informed Consent Form (ICF).

Exclusion Criteria:

* Underwent implantation of Sepramesh for any reason other than ventral hernia repair.

Primary outcomes:
measure: Hernia Recurrence Rate of Hernias Post Repair With Sepramesh.
timeFrame: 12 months or greater (average follow-up time of 3 years; range 13-65 months)
Secondary outcomes:
measure: Complications in Subjects With Hernias Repaired With Sepramesh.
timeFrame: 12 months or greater (average follow-up time of 3 years; range 13-65 months)
measure: Procedural Time for Sepramesh Placement.
timeFrame: Day 0
measure: Recovery Time Associated With Hernias Repaired With Sepramesh.
timeFrame: 12 months or greater (average follow-up time of 3 years; range 13-65 months)
Other outcomes:
Locations:
city: Centerville
country: United States
facility: Cornerstone Medical Center
state: Ohio
Study officials:
affiliation: Providence Medical Group and Cornerstone Medical Center
name: Andrew L Archer, MD
role: PRINCIPAL_INVESTIGATOR
References: