louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03001583: Clinical Trial Comparing Two Health Education Programs for Obese Patients (HEPO-TRIAL)
Official title: Clinical Trial Comparing Two Health Education Programs for Obese Patients: Groups With Health Education Plus Cooking Program vs. Only Education Without Cooking
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obesity
Keywords: Mediterranean diet
weight loss
type 2 diabetes
education program
cooking
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
First posted: 2016-12-23
Enrollment: 0
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: Clinical trial comparing two health education programs for obese patients in order to achieve a substantial and beneficial weight loss, using mediterranean diet. Patients will be allocated to two groups, one will receive education in diet and lifestyle, and the other one the same plus cooking lessons. The intervention period is for 6 months with monthly visits and phone and email contacts in between. An extension observation period of two years is also planned with 6 months contacts in our clinic, also with phone and email contact available.

Detailed description: Eligibility: obese patients attending our center. Exclusion criteria: previous dietary or anti-obesity drugs treatments, previous bariatric surgery, eating disorders, desire for short-term bariatric surgery, active neoplasia, end stage kidney or liver disease, food allergies or celiac disease.

Sample Size: a total of 260 patients (130 patients in each group) are needed for α=0.05 and 1-ß=0.8, to reach a difference of a 5% in weight loss between both groups, with a maximum of a 30% dropouts.

Intervention: structured health education program of Mediterranean diet and lifestyle changes with cooking lessons in monthly sessions, with the aid of phone and email contacts during an induction phase of 6 months, followed by an extension period of 18 months.

Control: same strategy without the cooking lessons. Primary outcome: weight loss in % Secondary outcomes: reversal in obesity associated comorbidities and quality of life.

Eligibility criteria: Inclusion Criteria:

* Obese patients attending our center

Exclusion Criteria:

* Previous dietary or pharmacologic treatment for obesity, previous bariatric surgery, desired bariatric surgery in the short-term, eating disorders, end-stage kidney or liver disease, active neoplasia, food allergies, celiac disease.

Primary outcomes:
measure: Weight loss
timeFrame: 6 months
Secondary outcomes:
measure: Weight loss
timeFrame: Visits at 12, 18 and 24 months (to complete a total study time period of 24 months)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04843683: StereoTactic Ablative RadioTherapy of Cardiac Arrhythmias (START-CA)
Official title: StereoTactic Ablative RadioTherapy of Cardiac Arrhythmias (START-CA): a Phase II Trial of Non-Invasive Treatment of Medically Refractory Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Arrhythmia
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2021-04-13
Enrollment: 60
Sex: ALL
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: This is a prospective, single-center, phase II trial that will be monitoring the safety and efficacy of using stereotactic ablative radiotherapy (SBRT) to treat patients with a medical condition affecting heart rate and rhythm (refractory arrhythmias) within the University Health Network (Princess Margaret Cancer Centre and Toronto General Hospital). The primary objective will be to prospectively monitor patient cardiac outcomes following SBRT.


Eligibility criteria: Inclusion Criteria:

* Patients with heart rate and rhythm condition (arrhythmia) who have failed standard of care treatment with medication OR at least one prior invasive catheter ablation procedure.
* Patients deemed medically fit to receive stereotactic ablative radiotherapy as determined by their Radiation Oncologist.

Exclusion Criteria:

* Patients who have previously received high dose radiotherapy to the target area and cannot safely receive further treatment OR are unable to receive radiotherapy due to other contraindications.

Primary outcomes:
measure: Change from Baseline in ICD therapies.
timeFrame: Baseline to 18 months follow-up.
measure: Change from Baseline in the number or dose of antiarrhythmic medications.
timeFrame: Baseline to 18 months follow-up.
Secondary outcomes:
measure: Measure patient quality-of-life during the study.
timeFrame: Baseline to 18 months follow-up.
measure: Measure patient quality-of-life during the study.
timeFrame: Baseline to 18 months follow-up.
measure: Measure patient subjective distress following treatment.
timeFrame: Baseline to 6 months follow-up
measure: Overall mortality record.
timeFrame: 6 to 18 months follow-up.
measure: Number of patients with acute and long-term toxicity as assessed by CTCAE v5.0.
timeFrame: 1 month to 18 months follow-up.
measure: Rates of hospital admissions.
timeFrame: Baseline to 18 months follow-up.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Center, University Health Network
state: Ontario
Study officials:
References:
Clinical trial NCT01077583: Performance Evaluation Study for Clearblue Pregnancy Test
Official title: Performance Evaluation Study for Clearblue Pregnancy Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Keywords: Pregnancy test
Wishing to become pregnant
Lead sponsor: SPD Development Company Limited
Sponsor class: INDUSTRY
First posted: 2010-03-01
Enrollment: 800
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Eligibility:

Ages Eligible for study: 18 - 45 years. Gender Eligible for study Female. Healthy Volunteers Yes.

Brief summary: The purpose of this study is to collect urine samples and dating scan information from women who wish to become pregnant. Urine samples will be tested in the laboratory with the Clearblue Pregnancy Test and the results correlated with volunteer information.

Detailed description: Approximately 800 female volunteers wishing to become pregnant will be recruited locally around 5 trial centers within the US.

Daily urine samples and gestational age dating scan information obtained from the study will be used in laboratory tests to assess the accuracy of the Clearblue Pregnancy Test. Product assessment will involve testing of early morning urine samples collected by women during the cycle in which they conceived. Urine samples will be collected pre-conception to the end of the second trimester.

Eligibility criteria: Inclusion Criteria:

* Provide written informed consent to participate in the study and agree to comply with study procedures.
* Has menstrual bleeds.
* Seeking to become pregnant.
* Intend to seek medical care during pregnancy.

Exclusion Criteria:

* Has positive pregnancy test on screening.
* Has received medical treatment for infertility or is participating in an assisted fertility program.
* Known condition to contra-indicate pregnancy.

Primary outcomes:
measure: The agreement of the Clearblue Pregnancy Test result with Duration of Pregnancy.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Radiant Research Inc
state: Georgia
city: Chicago
country: United States
facility: Radiant Research, Inc.
state: Illinois
city: Edina
country: United States
facility: Radiant Research Inc
state: Minnesota
city: Dallas
country: United States
facility: Radiant Research Inc
state: Texas
city: San Antonio
country: United States
facility: Radiant Research Inc
state: Texas
Study officials:
affiliation: Radiant Research
name: Phyllis Marx, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Larsen J, Buchanan P, Johnson S, Godbert S, Zinaman M. Human chorionic gonadotropin as a measure of pregnancy duration. Int J Gynaecol Obstet. 2013 Dec;123(3):189-95. doi: 10.1016/j.ijgo.2013.05.028. Epub 2013 Sep 3.
Clinical trial NCT02904083: Study of the Effectiveness of Specific Training of Health Professionals on Adherence in Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bipolar Disorders
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: Bipolar disorders are common psychiatric disorders characterized by severe and recurrent symptomatic periods (Major Depressive Episode, mania, hypomania) and interictal periods characterized by persistent residual symptoms, impaired functioning and quality of life. In addition, the prognosis of bipolar disorder is aggravated by an increased risk of suicide and a high frequency of somatic comorbidities. Poor adherence is one of the major factors influencing the course of the disorder and one of the causes of ineffective treatments. Considering that between 20 and 60% of patients with bipolar disorder have problems with adherence. Adherence is modulated by a number of socio-demographic, clinical and neuropsychological factors. It is also modulated by the knowledge, beliefs and In addition, studies have shown that the reasons attributed to poor adherence are different depending on whether questioning patients or healthcare professionals. This fault diagnosis, assessment of the causes and "fit" into the reasons associated with poor adherence is an aggravating factor of the problem. However, this factor seems modifiable by better training of professionals. A team from Newcastle University in England has developed a training program for all health professionals to improve the diagnosis and understanding of compliance issues in bipolar patients and provide simple tools to fight against patients with this problem. The investigators assume that this training will improve medication adherence among outpatients by trained professionals.


Eligibility criteria: Inclusion Criteria:

* Suffering from bipolar disorder type 1, type 2 or unspecified according to the DSM IV
* Do not presenting mood episode as defined in DSM IV
* With at least one medication prescribed mood stabilizer goal, whatever its observance

Exclusion Criteria:

* Patients full-time hospitalized at the time of inclusion

Primary outcomes:
measure: Difference of score of Medication Adherence Rating Scale (MARS) before and after the training of the professionals
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Urielle Desalbres
role: STUDY_DIRECTOR
References:
Clinical trial NCT05752383: The Clinical and Hemodynamic Course of Cardiogenic Shocks Hospitalized in Critical Care
Official title: The Clinical and Hemodynamic Course of Cardiogenic Shocks Hospitalized in Critical Care
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiogenic Shock
Keywords: Cardiogenic Shock
vaso-inotropic score
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Patients hospitalized in ICU for cardiogenic shock
* Patient with cardiogenic shock as defined by the FRENSCHOCK2 study criteria

Brief summary: Cardiogenic shock is a frequent reason for hospitalization in critical care units, with high mortality (50%). Several French registries have been created to improve knowledge of the prognostic factors of cardiogenic shock. In recent years, temporary mechanical circulatory support has become more important in cardiogenic shock. The monitoring of catecholamines is also performed with a global score: the vaso-inotropic score. The purpose of our study is to consider using these new data and techniques to create a cohort of cardiogenic shock within our critical care unit.

This observational study is based on clinical, biological, and hemodynamic data recorded during the ICU stay of patients for cardiogenic shock.

The primary endpoint is the relationship between the hemodynamic evolution of cardiogenic shock and in-hospital mortality.


Eligibility criteria: Inclusion Criteria:

* Patients hospitalized in ICU for cardiogenic shock
* Patient with cardiogenic shock as defined by the FRENSCHOCK2 study criteria

Exclusion Criteria:

* Patient with cardiogenic shock in the context of septic shock and hemorrhagic shock

Primary outcomes:
measure: Percentage of in-hospital mortality after cardiogenic shock
timeFrame: 5 years
measure: Vaso-inotropic score after cardiogenic shock
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
Study officials:
References:
Clinical trial NCT04184583: Registry Study on Drug Therapy and Clinical Outcomes in Patients With Acute Coronary Syndrome
Official title: Registry Study on Drug Therapy and Clinical Outcomes in Patients With Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Drug Therapy
Acute Coronary Syndrome
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2019-12-03
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Acute Coronary Syndrome with blood concentration monitoring or genetic testing at the pharmacy department of Beijing Anzhen Hospital from January 1, 2018.Those who fill the inclusion criteria at screening will be invited for the registry study into different groups.

Brief summary: Registry Study on Drug Therapy and Clinical Outcomes in Patients With Acute Coronary Syndrome


Eligibility criteria: Inclusion Criteria:

* Informed consent has been signed.
* Patients diagnosed in our hospital with acute coronary syndrome.
* Age ≥18.
* Life expectancy ≥12 months.

Exclusion Criteria:

* Severe lack of important information such as history of previous medication, history of previous disease, history of surgery.
* Pregnant and lactating women.
* Mental disorders, or inability to communicate effectively with researchers, or failure to comply with research protocols.

Primary outcomes:
measure: main adverse cardiovascular and cerebrovascular events (MACCE)
timeFrame: up to 5 years
Secondary outcomes:
measure: Adverse drug reaction
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT02871583: Effect of Inguinal Hernia Repair on Isokinetic Muscle Strength
Official title: The Evaluation of Trunk Muscle Strength, Quality of Life, and Neuropathic Pain Component After Two Different Inguinal Hernia Repair Techniques; A Prospective Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Lead sponsor: Konya Meram State Hospital
Sponsor class: OTHER
First posted: 2016-08-18
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: The aim of the present prospective controlled study is to compare the trunk muscle strength, quality of life and neuropathic pain component after Lichtenstein and Kugel procedures.

Detailed description: In this study patients underwent inguinal hernia repair will be evaluated for the effect of the surgical procedure on abdominal muscle strength.

Eligibility criteria: Inclusion Criteria:

* Signed written informed consent
* Male gender (for minimizing the certain effect of gender to muscle strength)
* Patients aged 18-65 years' old
* Having no previous surgery
* Patients within six months to postoperative first year
* Ability to speak, read, and write Turkish

Exclusion Criteria:

* Infections or tumors of the spine
* Systemic bone or joint disorders (e.g., rheumatoid arthritis)
* Unstable cardiovascular and pulmonary diseases
* Polyneuropathies and musculoskeletal system diseases
* Presence of a diagnosed severe psychiatric disorder
* Presence of severe pain
* Regular exercise habit
* Recurrent operation for a hernia
* Presence bilateral inguinal hernia on concurrent femoral hernia
* If the calculated Body mass index is lower than 20kg/cm2 or over than 35kg/cm2

Primary outcomes:
measure: isokinetic muscle strength
timeFrame: 6 - 12 months
Secondary outcomes:
measure: quality of life assesment
timeFrame: 6 -12 months
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Konya Training and Research Hospital
Study officials:
References:
Clinical trial NCT03754283: Transfer Accuracy of Indirectly Bonded Orthodontic Braces With Different Transfer Trays
Official title: Transfer Accuracy of Indirectly Bonded Orthodontic Attachments With Vacuum Formed and Silicone Transfer Trays
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion
Keywords: Indirect bonding
Accuracy
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 16
Sex: ALL
Minimum age (years): 15
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1
Primary purpose: TREATMENT

Brief summary: The aim of this study is to comparatively investigate the performances of two different and widely used transfer trays during indirect bonding of the orthodontic braces.

Detailed description: The aim of the study is to compare the accuracy of orthodontic bracket and tube transfer between double layer silicone and double layer vacuum formed trays. The sample included 368 attachments bonded in 16 patients. Each patient received one silicone and one vacuum formed tray which were randomly allocated to provide 8 trays of each type for the upper and lower arches. 3D scan data and local best-fit alignments were used to calculate the translational and rotational movements of the orthodontic attachments. Chi-square and Mann-Whitney U tests were used to compare transfer accuracy and success between the groups.

Eligibility criteria: Inclusion Criteria:

* The presence of indication for both arches to be bonded in the same appointment

Exclusion Criteria:

* Presence of restorations, hypoplasia or decalcification on vestibular tooth surfaces
* Abnormal crown morphology

Primary outcomes:
measure: Transfer accuracy (composite outcome) in milimetres and degrees. Which is measured on computer software.
timeFrame: Day 0 - Day 2
Secondary outcomes:
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Cihan Aydoğan
Study officials:
References:
Clinical trial NCT00197483: Effective Adjunctive Use of Pergolide for Cognitive Impairment and Negative Symptoms in Schizophrenia
Official title: Effective Adjunctive Use of Pergolide With Risperidone for Cognitive Impairment and Negative Symptoms in Schizophrenia
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Schizophrenia
Negative Symptoms
Cognitive Impairments
Keywords: Pergolide
Dopamine D1
Schizophrenia
Cognitive disturbance
Negative symptoms
Lead sponsor: Hamamatsu University
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: Dopamine has been closely associated with prefrontal function. The hypothesis that a lower dopaminergic activity is associated with negative symptoms and cognitive dysfunction observed in the patients of schizophrenia is of a heuristic value in guiding research in this area. This hypothesis led us to test whether pergolide, a D1/D2 agonist, could improve negative symptoms and cognitive impairments prevailing in most patients with schizophrenia. This double-blind placebo controlled study will investigate the remedial effect of pergolide on negative symptoms and cognitive impairments in schizophrenia.


Eligibility criteria: Inclusion Criteria:

Patients

* Were age 18-50 years, met the DSM-IV criteria for schizophrenia
* Were treated with a stable dose of risperidone, raging 2 to 6mg, for more than 8 weeks
* Had a score ≥15 on negative subscale items in Positive and Negative Syndrome Scale (PANSS)
* Had a minimum period of symptom stability, defined as no more than 20% change on consecutive ratings on PANSS for at lease 4 weeks

Exclusion Criteria:

* Had a history of medical condition or drug treatment that may have affected cognitive performance
* Had a history of other psychiatric disorders

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital
state: Shizuoka
Study officials:
affiliation: Hamamatsu University, School of Medicine, Department of Psychiatry and Neurology
name: Norio Mori, Ph.D
role: STUDY_CHAIR
References:
citation: Kimberg DY, D'Esposito M. Cognitive effects of the dopamine receptor agonist pergolide. Neuropsychologia. 2003;41(8):1020-7. doi: 10.1016/s0028-3932(02)00317-2.
citation: Muller U, von Cramon DY, Pollmann S. D1- versus D2-receptor modulation of visuospatial working memory in humans. J Neurosci. 1998 Apr 1;18(7):2720-8. doi: 10.1523/JNEUROSCI.18-07-02720.1998.
citation: Wang M, Vijayraghavan S, Goldman-Rakic PS. Selective D2 receptor actions on the functional circuitry of working memory. Science. 2004 Feb 6;303(5659):853-6. doi: 10.1126/science.1091162.
citation: Goldman-Rakic PS, Castner SA, Svensson TH, Siever LJ, Williams GV. Targeting the dopamine D1 receptor in schizophrenia: insights for cognitive dysfunction. Psychopharmacology (Berl). 2004 Jun;174(1):3-16. doi: 10.1007/s00213-004-1793-y. Epub 2004 Apr 30.