louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02410785: Efficacy of Polyglucosamine for Weight Loss
Official title: Efficacy of Polyglucosamine for Weight Loss - in a Randomized, Double-blind, Placebo-controlled Clinical Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: obesity,
body weight,
overweight,
weight loss,
polyglucosamine,
L112
caloric restriction
physical activity
Lead sponsor: Certmedica International GmbH
Sponsor class: INDUSTRY
First posted: 2015-04-08
Enrollment: 115
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The polyglucosamine, specification L112 is a medical device and in this clinical trial used for weight reduction of overweight and obese participants. The rationale for this study is to show that overweight can be reduced by taking 2 times daily 2 tablets with the main meals with the highest fat content.

Detailed description: To have a comparable diet condition, all participants in both groups had to follow the recommendations of the German clinical practice guidelines on the management and prevention of obesity.

One group had to take the polyglucosamine tablets and the other group placebo tablets for at least 24 weeks. It is known, that polyglucosamine is a fat binder acting in a physical-chemical manner, the positive charged fiber is bound to the negative charged dietary fat and this complex in unable to pass the gut wall into the body but is naturally excreted, hence this energy is not available. Therefore, this medical device should show a measurable reduction in body weight.

Eligibility criteria: Inclusion Criteria:

* BMI \> 26 and \< 45
* waist circumference of more than 88 cm for women and greater than 102 for men.

Exclusion Criteria:

* pregnancy or breast-feeding, alcohol abuse, drug abuse or drug addiction, inability to fulfill the criteria of the trial protocol, cancer diseases, malignant tumors, pre-existence of chronic intestinal disease and known hypersensitivity reactions to crustaceans

Primary outcomes:
measure: Number of participants who could reduce their body weight by 5 or more per cent compared to the initial body weight.
timeFrame: 24 weeks
Secondary outcomes:
measure: Change of body weight in kg
timeFrame: 24 weeks
measure: Change of BMI
timeFrame: 24 weeks
measure: Reduction of waist circumference
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Bad Soden-Salmünster
country: Germany
facility: Salztal Klinik GmbH
state: Hessia
city: Rende
country: Italy
facility: MAP Center
state: Cosenza
Study officials:
affiliation: Salztal Klinik GmbH
name: Karina Pokhis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pokhis K, Bitterlich N, Cornelli U, Cassano G. Efficacy of polyglucosamine for weight loss-confirmed in a randomized double-blind, placebo-controlled clinical investigation. BMC Obes. 2015 Jun 10;2:25. doi: 10.1186/s40608-015-0053-5. eCollection 2015.
Clinical trial NCT04228185: Banded Sleeve Gastrectomy Improves Weight Loss Compared to Non-banded Sleeve: Mid-term Results
Official title: Banded Sleeve Gastrectomy Improves Weight Loss Compared to Non-banded Sleeve: Mid-term Results From a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Morbid
Keywords: Sleeve gastrectomy
banded sleeve
obesity surgery
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2020-01-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Weight regain after Laparoscopic Sleeve Gastrectomy (LSG) is nowadays a growing concern. Sleeve dilatation and loss of food restriction is considered the main mechanism. The placement of a silicon ring around the gastric tube seems to give benefits in the short-term.

The Investigators evaluate the efficacy of banded sleeve gastrectomy compared to standard sleeve in the mid-term.

Fifty patients were randomized between LSG and Laparoscopic Banded Sleeve Gastrectomy (LBSG), and they underwent a mean follow-up of 4 years.

Patients' management was exactly the same, apart from the band placement. After surgery differences in weight loss, operative time, complication rate and mortality were analyzed.


Eligibility criteria: Inclusion Criteria:

* Morbid obesity
* Failure of medical treatment
* \>18yrs; \<60 yrs

Exclusion Criteria:

* Previous bariatric or GI surgery
* Psychiatric disease
* Pregnancy
* Contraindication to laparoscopy

Primary outcomes:
measure: weight loss
timeFrame: from surgery to 4 years follow up
Secondary outcomes:
measure: Complications
timeFrame: from surgery to 4 years follow up
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Tor Vergata University Hospital
Study officials:
affiliation: Tor Vergata University Hospital
name: Stefano D'Ugo, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gentileschi P, Bianciardi E, Siragusa L, Tognoni V, Benavoli D, D'Ugo S. Banded Sleeve Gastrectomy Improves Weight Loss Compared to Nonbanded Sleeve: Midterm Results from a Prospective Randomized Study. J Obes. 2020 May 28;2020:9792518. doi: 10.1155/2020/9792518. eCollection 2020.
Clinical trial NCT05896085: Game Based Assessment of Emotion-regulation Skills in College Students
Official title: Game Based Assessment of Emotion-regulation Skills in College Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Assessment
Emotion Regulation
Keywords: online therapeutic game
emotion regulation
college students
mental health
game-based assessment
Lead sponsor: Babes-Bolyai University
Sponsor class: OTHER
Collaborators: name: The Executive Agency for Higher Education, Research, Development and Innovation Funding
First posted: 2023-06-09
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of this study will be to investigate the validity of the in-game performance measurements or scores as indicators of students'ER abilities.


Eligibility criteria: Inclusion Criteria:

* first year student at Babes-Bolyai University
* internet and PC access to complete the scales and game

Exclusion Criteria:

* no internet or PC access

Primary outcomes:
measure: Mental Health
timeFrame: baseline, pre-intervention
measure: Emotion regulation
timeFrame: baseline, pre-intervention
Secondary outcomes:
measure: MAAS
timeFrame: baseline, pre-intervention
measure: Rational and irrational cognition
timeFrame: baseline, pre-intervention
measure: Atention to positive and negative information
timeFrame: baseline, pre-intervention
measure: emotional distress
timeFrame: baseline, pre-intervention
measure: emotional awareness
timeFrame: baseline, pre-intervention
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Babes-Bolyai University
Study officials:
References:
Clinical trial NCT01479985: Computerized Contraceptive Decision Aid
Official title: Randomized Clinical Trial of a Computerized Contraceptive Decision Aid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Decision Making
Satisfaction
Evaluation
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2011-11-28
Enrollment: 253
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to conduct a randomized clinical trial of a web-based contraceptive decision aid compared to routine contraceptive counseling to evaluate the effect of the contraceptive decision aid on the contraceptive method selected by the participant.

The investigators primary hypothesis is that women utilizing a computerized Contraceptive Decision Aid (CDA) will be more likely to choose highly effective contraception than women who undergo standard clinical contraceptive counseling.

Detailed description: Our primary specific aim is to test the CDA by conducting a randomized clinical trial comparing the CDA to routine contraceptive counseling. Our primary outcome of interest will be selection of highly effective contraception including the intrauterine device (IUD), the implant, and injectable contraception compared to all other reversible contraceptive methods.

We will also complete the following secondary specific aims:

1. We will use the validated Decisional Conflict Scale to measure decisional conflict pre- and post-intervention and compare the change in decisional conflict score in women randomized to the CDA to women undergoing routine counseling.
2. We will also evaluate satisfaction with contraceptive counseling and contraceptive continuation and satisfaction at 3 and 6 months.

Eligibility criteria: Inclusion Criteria:

* Ages 18-45 years old
* At risk for unintended pregnancy and seeking reversible contraception at Center of Advanced Medicine or Washington University Resident's Clinic
* Willing and able to complete Contraceptive Decision Making tool
* English speaking

Exclusion Criteria:

* Have had a hysterectomy, bilateral oophorectomy, have undergone female sterilization
* Unable to give informed consent secondary to language barrier or cognitive limitation

Primary outcomes:
measure: Decisional Conflict Scale Score
timeFrame: Pre-Visit and Post-Visit (same day)
Secondary outcomes:
measure: Contraceptive Method Chosen
timeFrame: Post-visit (immediately after visit)
Other outcomes:
Locations:
Study officials:
affiliation: Washington University School of Medicine
name: Tessa E Madden, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01500785: Intracoronary Administration of Levosimendan in Cardiac Surgery Patients
Official title: Intracoronary Administration of Levosimendan in Cardiac Surgery Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Myocardial Stunning
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2011-12-28
Enrollment: 50
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: Incomplete recovery from ischemia causes stunned myocardium. Ischemia may be due to coronary artery disease or aortic cross-clamping during surgery. Stunning leads to myocardial dysfunction. It has been suggested that the mechanism responsible for the contractile depression in stunned myocardium is a decreased sensitivity of the myofibrils to calcium. Levosimendan is a calcium sensitizer, which has been shown to improve the function of stunned myocardium without obvious impairment of diastolic function. Systemic vasodilation and need of vasoconstrictive medication is usually apparent after administration of levosimendan. Colucci et al have demonstrated that with intracoronary administration of milrinone, another inodilator, systemic vasodilation could be excluded. If this is true with levosimendan, it may be possible to improve left ventricular hypo/dyskinesia without afterload reduction by adding levosimendan into cardioplegia solution.

The investigators hypotize that levosimendan, delivered together with cardioplegia, can improve LV dysfunction after opening of aortic cross-clamp in patients undergoing aortic valve and coronary artery bypass operation. Our primary endpoint is a change in cardiac output 15 min after separation from cardiopulmonary bypass compared to the baseline. Secondary endpoints are a change in LV ejection fraction from baseline to 5 min after sternal closure and cTnT/CK-MB on the first postoperative morning.


Eligibility criteria: Inclusion Criteria:

* preoperative LVEF 40% or less
* septal wall thickness more than 11mm
* less than moderate aortic insufficiency
* sinus rhythm before CPB

Exclusion Criteria:

* oesophageal disease
* known allergy to levosimendan or its metabolites or adjuvants.

Primary outcomes:
measure: change in cardiac output
timeFrame: from baseline to 15min after weaning from CPB
Secondary outcomes:
measure: EF
timeFrame: from baseline to 5 min after sternal closure
measure: cTnT/CK-MB on the first postoperative morning.
timeFrame: from baseline to 1st post. op. morning
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Heart Center Co. Tampere university hospital
Study officials:
affiliation: Heart Center Co. Tampere university hospital
name: Panu Virkkala, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01747785: Myocardial Performance at Rest and During Exercise in Heart Failure With Preserved Ejection Fraction
Official title: Myocardial Performance at Rest and During Exercise in Heart Failure With Preserved Ejection Fraction: Speckle Tracking Echocardiography - One Piece of the Puzzle.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Heart Failure
Keywords: Heart failure
HFpEF
Dyspnea
Fatigue
Shortness of Breath
exercise
strain
myocardial deformation
cardiac rehabilitation
cardiac hemodynamics
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-12-12
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: This study is being done to study how well the heart contracts and relaxes during exercise. In addition to traditional measures of heart function, we will use a new computer program that may improve understanding of why people feel shortness of breath or fatigue.

Detailed description: Heart failure with preserved ejection fraction is not well understood, although account for nearly half of all heart failure cases. This study aims to collect data about systolic (contracting portion of a heart beat) and diastolic (relaxing portion of a heart beat) dysfunction at rest and during exercise. Participants with normal cardiac function will serve as a control group and compared to participants who are at risk of heart failure.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older,
* able to exercise on a bicycle

Exclusion Criteria:

* heart arrhythmias,
* severe chronic obstructive pulmonary disease,
* congenital heart abnormalities,
* infiltrative or hypertrophic cardiomyopathy.

Primary outcomes:
measure: Change in mean cardiac reserve as measured by strain rate
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Change in mean cardiac stroke volume
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: La Crosse
country: United States
facility: Mayo Clinic Health System - Franciscan Healthcare
state: Wisconsin
Study officials:
affiliation: Mayo Clinic
name: Hector Villarraga, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04091685: D Tc 99m Dimercaptosuccinic Acid SPECT Versus Planar
Official title: Added Value of Tc99m Dimercaptosuccinic Acid SPECT Versus Planar Imaging in Detection of Renal Cortical Defects
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dimercaptosuccinic Acid SPECT and Planar
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-17
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with history of peylo nephritis ,malrotated kidney ,ectopic kidney with no age limitation

Brief summary: Knowing what will DMSA spect add to the DMSA planar in detection in renal cortical defects


Eligibility criteria: Inclusion Criteria:

* patient with history of peylo nephritis.

Exclusion Criteria:

* pregnant women

Primary outcomes:
measure: Comparison between DMSA spect and planar imaging
timeFrame: Baseline
Secondary outcomes:
measure: Clarify added value of DMSA spect over planar
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04056585: Intermittent Compression Maneuver of Upper Arm to Reduce Axillary Brachial Plexus Block Onset Time
Official title: Intermittent Pneumatic Compression May Reduce Brachial Plexus Block Onset Time
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Forearm Injuries
Hand Injuries
Keywords: brachial plexus block
intermittent pneumatic compression maneuver
Lead sponsor: Catholic Kwandong University
Sponsor class: OTHER
First posted: 2019-08-14
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the addition of intermittent pneumatic compression maneuver to axillary brachial plexus block in forearm and hand surgery. Half of participants will receive axillary brachial plexus block and intermittent pneumatic compression maneuver, while the other half will receive only axillary brachial plexus block.


Eligibility criteria: Inclusion Criteria:

1. adults between ages of 20 and 50
2. patients who are scheduled forearm and hand surgery with axillary brachial plexus block
3. American Society of Anesthesiologists Physical Status classification 1 or 2
4. patients who voluntarily agree to participate in the trial

Exclusion Criteria:

1. patients who are pregnant or lactating
2. patient who does not agree to participate in the study
3. patient with side effects on local anesthetics
4. patient with neurologic deficit of upper arm
5. patients with comorbidities of cardiac, pulmonary, renal, cerebral, and hepatic systems
6. patients with peripheral vascular disease

Primary outcomes:
measure: Time to achieve complete sensory block
timeFrame: 1 hour
Secondary outcomes:
measure: Time to achieve surgical anaesthesia
timeFrame: 1 hour
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: International St. Mary's Hospital
Study officials:
References:
Clinical trial NCT00858585: Genetic Risk of Osteonecrosis of the Jaw (ONJ) in Patients With Metastatic Cancer: Concordance Study
Official title: Genetic Risk of Osteonecrosis of the Jaw (ONJ) in Patients With Metastatic Cancer: Concordance Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Bone metastasis, SNP concordance
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2009-03-10
Enrollment: 149
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: breast cancer patients

Brief summary: This study will examine genes in three different tissues and look for similarities and differences between normal cells and cancer cells. The tissues to be studies come from blood, lymph node and cancer.

Detailed description: Subjects will be given an informed consent to read and sign The medical chart will be reviewed for diagnosis and treatment history Blood (about 4 tablespoons) will be drawn at a clinically available time. The lymph node and breast tumor tissue in the University of Michigan pathology repository will be used for research purposes

Eligibility criteria: Inclusion Criteria:

* Age at least 18 years of age
* Able to read and sign the informed consent
* Able to provide specimens: one blood draw for white blood cells, provide permission to use tissue already collected.

Primary outcomes:
measure: Single nucleotide polymorphisms
timeFrame: time-independent
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Catherine Van Poznak, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00837785: A 24-Hour Pharmacokinetic Determination of BG00012 After Single-Day Oral Administration in Subjects With MS
Official title: A 24-Hour Pharmacokinetic Determination of BG00012 After Single-Day Oral Administration in Subjects With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Relapsing Remitting Multiple Sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2009-02-05
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To establish a pharmacokinetic (PK) profile of BG00012, as measured by its primary metabolite, monomethyl fumarate (MMF), during a 24-hour dosing period in subjects with relapsing-remitting multiple sclerosis (RRMS), with a variety of baseline demographic characteristics.


Eligibility criteria: Inclusion Criteria:

1. Aged 18 to 55 years old, inclusive, at the time of informed consent.
2. Have a confirmed diagnosis of RRMS according to McDonald criteria #1-4.
3. Be ambulatory.

Exclusion Criteria:

1. Primary progressive, secondary progressive, or progressive-relapsing multiple sclerosis (PRMS).
2. History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (other than MS), dermatologic, psychiatric, renal, oncologic, anaphylaxis or other major diseases, as determined by the Investigator.
3. Current enrollment in any other drug, biologic, or device study or treatment with another investigational drug within 6 months or 5 half-lives of the investigational product, whichever time period is longer.
4. Serious infection (e.g., pneumonia, septicemia) within the 2 months prior to Day -1.
5. Pregnant or nursing women.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: To establish a PK profile of MMF during a 24-hour BG00012 dosing period in subjects with RRMS
timeFrame: 24 Hours
Secondary outcomes:
measure: To explore the relationship of differences in baseline demographics and dosing factors in the disposition of BG00012
timeFrame: 24 Hours
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Research Site
Study officials:
References: