louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00596739: A Study of the Pre- and Post-operative Semen Analyses and Reproductive Hormone Levels of Men Undergoing Weight-reduction Surgery
Official title: Weight Loss Surgery and Male Fertility
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Male Infertility
Keywords: Bariatric surgery, weight loss surgery, male infertility, Roux-En-Y, gastric banding
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2008-01-17
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult male subjects between the ages of 18-65 undergoing bariatric surgery

Brief summary: A correlation between obesity and male fertility has been observed in a few clinical studies. Normal weight men appear to have higher sperm concentrations and sperm motility when compared to obese men, suggesting that weight loss might improve sperm function. However, there also are reported cases of severe male factor infertility following weight loss surgery in previously fertile men. The aim of this study is to determine if there are differences in the semen analyses and hormone levels of men obtained before and after undergoing weight loss (bariatric) surgery.

This will direct future research and treatment.

Detailed description: We will recruit 60 subjects for this study. Volunteers will provide pre-operative semen and blood samples prior to undergoing weight-reduction surgery.

Those with normal pre-operative sperm samples will be invited to continue participating in the study by providing subsequent post-operative semen samples and hormonal testing over a two year time period.

It is estimated to take approximately one year to enroll the desired 60 subjects. The study will conclude two years from the last enrollment.

The main analysis will be a comparison of sperm concentrations over time.

Eligibility criteria: Inclusion Criteria:

* Adult male subjects between the ages of 18-65 undergoing bariatric surgery

Exclusion Criteria:

* Subjects with abnormal sperm analysis

Primary outcomes:
measure: Changes in semen analyses and reproductive hormone measurements
timeFrame: 2 years
Secondary outcomes:
measure: Trends in semen analysis & reproductive hormone parameters over the two-year data collection period, Changes in semen analysis & reproductive hormone parameters as a function of BMI
timeFrame: 2 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Samantha F Butts, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00092339: A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-190)(COMPLETED)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study to Evaluate the Effects of Rofecoxib 50 mg and Valdecoxib 40 mg in Patients With Postoperative Dental Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Pain
Keywords: dental surgery
molar removal
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2004-09-27
Enrollment: 125
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following dental surgery.

Detailed description: The duration of treatment is 1 day.

Eligibility criteria: Inclusion Criteria:

* Impaction of a molar tooth requiring removal

Exclusion Criteria:

* Any known allergy to the study drugs

Primary outcomes:
measure: Overall analgesic effect as measured by total pain relief over 12 hours.
Secondary outcomes:
measure: Overall analgesic effect over 8 hrs.
measure: Time to onset of analgesic, peak analgesic and duration of analgesic effects.
measure: Percent of patients using and amount used of supplemental analgesia within 8, 12, and 24 hrs.
measure: Overall safety and tolerability.
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Daniels SE, Desjardins PJ, Bird SR, Smugar SS, Tershakovec AM. Rofecoxib 50 mg and valdecoxib 20 or 40 mg in adults and adolescents with postoperative pain after third molar extraction: results of two randomized, double-blind, placebo-controlled, single-dose studies. Clin Ther. 2006 Jul;28(7):1022-34. doi: 10.1016/j.clinthera.2006.07.005.
Clinical trial NCT03032939: The Effect of Tracheal Intubation on AC and DC Components of a Photoplethysmograph
Official title: The Effect of Tracheal Intubation Induced Autonomic Response on Photoplethysmography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia Intubation Complication
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2017-01-26
Enrollment: 35
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: Elective, healthy surgical patients over 18 yrs of age

Brief summary: Intraoperative stress responses (vasoconstriction and changes in heart rate) and postoperative pain can be monitored using photoplethysmography (PPG). PPG measures changes in tissue volume noninvasively. Therefore it can measure acute changes in arterial diameter (vasoconstriction). PPG signal has two components, AC and DC. Effects of noxious stimuli-induced stress responses (vasoconstriction) have not been studied on the DC component of PPG. The aim of this study was to investigate the effect of a known noxious stimulus (endotracheal intubation) on both the AC and DC components of PPG.


Eligibility criteria: Inclusion Criteria:

* Elective surgery
* General endotracheal anesthesia
* Over 18 years of age
* Healthy

Exclusion Criteria:

* Vascular disease
* Liver or kidney disease
* Overweight

Primary outcomes:
measure: Photoplethysmography
timeFrame: within 60 seconds of intubation
Secondary outcomes:
measure: Pulse rate
timeFrame: within 60 seconds of intubation
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Francisco
name: Pekka O Talke, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Talke P. The Effect of Tracheal Intubation-Induced Autonomic Response on Photoplethysmography. Anesthesiol Res Pract. 2017;2017:7646541. doi: 10.1155/2017/7646541. Epub 2017 Apr 2.
Clinical trial NCT01895439: Safety and Efficacy Study of Autologus Bone Marrow Mesenchymal Stem Cells in Multiple Sclerosis
Official title: Phase II Study: Use of Autologus Mesenchymal Stem Cells in Multiple Sclerosis Patients Who do Not Respond to Conventional Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Multiple Sclerosis
Keywords: Bone marrow derived Mesenchymal Stem Cells
Multiple Sclerosis
Oligodendrocytes
Neuroimmunology
Autoimmune disease
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2013-07-10
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 1. Expanding and priming Bone Marrow (BM)- Mesenchymal Stem Cells (MSCs) to a clinical scale according to Good Laboratory Practice using xenogenic free media instead of the previously used FCS.
2. Assessing the safety of injecting autologous BM-MSCs to Multiple Sclerosis (MS)patients who fail to respond to conventional treatment.
3. Assessing the therapeutic benefits on the participants in the trial as per established methods.


Eligibility criteria: Inclusion Criteria:

* A clinical diagnosis of definite MS according to the revised McDonald Criteria.
* Expanded Disability Status Scale (EDSS) ≤ 6
* Failure of standard medical therapy
* Disease duration of at least three years prior to enrollment.

Exclusion Criteria:

* Pregnant and lactating women
* Previous treatment with immunosuppressive agents in the last 12 months prior to enrollment
* Recent MS relapse in the month prior to enrollment
* Treatment with oral or parenteral steroids for any cause in the month prior to enrollment
* Significant systemic medical disorders including cardiac, renal, hepatic, hematologic, immunologic or endocrine disorders
* Previous treatment with interferons or glatiramer acetate in the 3 months prior to enrollment
* Any contra-indication for magnetic resonance imaging (MRI) or gadolinium contrast.
* Positive serology for HIV, Hepatitis B or Hepatitis C
* Any history of malignancy or exposure to radiation at any time prior to enrollment
* Any contra-indication to lumbar puncture
* Severe cognitive impairment that would interfere with the patient's ability to understand and sign the informed consent.

Primary outcomes:
measure: The number of patients with any relevant side effects observed
timeFrame: 18 months
Secondary outcomes:
measure: Assessing the therapeutic benefits of the injected Autologous Mesenchymal Stem Cells by Magnetic Resonance Imaging (MRI) and ophthalmological tests.
timeFrame: 18 months
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Cell Therapy Center, Jordan University Hospital
Study officials:
affiliation: Cell Therapy Center
name: Abdallah Awidi, MD.
role: STUDY_DIRECTOR
affiliation: Jordan University Hospital
name: Said Dahbour, MD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05960539: Robotic Curriculum for Young Surgeons
Official title: Robotic Curriculum for Young Surgeons
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Robotic Surgery
Keywords: robotic surgery
NASA Task Load Index
training
curriculum
Lead sponsor: Otto-von-Guericke University Magdeburg
Sponsor class: OTHER
First posted: 2023-07-25
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * every surgery for which patients gave their consent to participating in the study
* every surgeon giving consent of collecting data via this study

Brief summary: Robotic training program for unexperienced novice surgeons

Detailed description: The curricular structure of RoCS bases on five modules: multimodular didactics, standardization, training structure, interdisciplinary workplace and evaluation. The aim is to ensure a basic competence of robotic surgcial skills for unexperienced novice surgeons (residents).

Eligibility criteria: Inclusion Criteria:

* robotic procedures

Exclusion Criteria:

* no consent of patients or surgeons

Primary outcomes:
measure: perioperative morbidity
timeFrame: 5 years
measure: patient mortality rate
timeFrame: 5 years
measure: intraoperative workload
timeFrame: 5 years
measure: basic robotic competence
timeFrame: 5 years
Secondary outcomes:
measure: patient characteristics
timeFrame: 5 years
measure: patient laboratory parameters
timeFrame: 5 years
measure: surgical expertise
timeFrame: 5 years
measure: practical resident training
timeFrame: 5 years
measure: robotic bedside assistance
timeFrame: 5 years
Other outcomes:
Locations:
city: Magdeburg
country: Germany
facility: Otto-von-Guericke University Magdeburg
state: Saxony-Anhalt
Study officials:
affiliation: Otto-von-Guericke University of Magdeburg
name: Roland S. Croner, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01601639: Endoscopic Band Ligation Versus Argon Plasma Coagulation for the Treatment of Gastric Antral Vascular Ectasia: a Randomized Clinical Trial
Official title: Endoscopic Band Ligation vs Argon Plasma Coagulation for the Treatment of Gastric Antral Vascular Ectasia: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Antral Vascular Ectasia
Keywords: Gastric Antral Vascular Ectasia
Argon plasma Coagulation
Endoscopic Band Ligation
GAVE
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2012-05-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators goal is to compare the standard argon plasma coagulation (APC) treatment with endoscopic band ligation (EBL) in patients with Gastric Antral Vascular Ectasia.

Detailed description: Gastric antral vascular ectasia (GAVE) is a vascular structural malformation in the stomach that can lead to active or chronic intermittent gastrointestinal bleeding or chronic iron-deficiency anemia.

The current standard endoscopic treatment is with APC. There have been multiple reports and case series in the literature about successful treatment with EBL for GAVE, even in cases where APC was unsuccessful for treatment of GAVE. Our goal is to compare the standard APC treatment with EBL in patients with Gastric Antral Vascular Ectasia.

Eligibility criteria: Inclusion Criteria:

* Consecutive patients with GAVE identified at endoscopic examination, patients may have active GI bleeding, chronic anemia or drop in hemoglobin levels.

Exclusion Criteria:

* Patients with previous endoscopic treatment for GAVE within the last 3 months, patients with GAVE without chronic anemia or active bleeding, patients in whom another possible source of GI bleeding is found

Primary outcomes:
measure: New event of upper gastrointestinal bleeding
timeFrame: one year
Secondary outcomes:
measure: Number of sessions required for GAVE eradication
timeFrame: one year
measure: Total procedure time
timeFrame: one year
measure: Blood transfusion requirements
timeFrame: one year
measure: Iron studies
timeFrame: one year
measure: Ferritin
timeFrame: one year
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
Study officials:
References:
citation: Zepeda-Gomez S, Sultanian R, Teshima C, Sandha G, Van Zanten S, Montano-Loza AJ. Gastric antral vascular ectasia: a prospective study of treatment with endoscopic band ligation. Endoscopy. 2015 Jun;47(6):538-40. doi: 10.1055/s-0034-1391395. Epub 2015 Feb 4.
Clinical trial NCT02767739: Effects of Physical Activity on Cardiovascular Risk and Quality of Life
Official title: A Randomized Community Trial of Physical Activity Intervention in Primary Healthcare to Improve Cardiovascular Risk Factors and Health-Related Quality of Life in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Quality of Life
Lead sponsor: University Rovira i Virgili
Sponsor class: OTHER
First posted: 2016-05-10
Enrollment: 419
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Community intervention trial, randomized, to promote regular PA and social and cultural support activities for 9 months in older-adult primary care users and assess their effects on cardiovascular risk factors and health-related quality of life.

Detailed description: A structured program to promote Physical , according to the recommended guidelines and supervised by healthcare personnel should be deployed to assess their short, medium and long-term effects on CVD risk and Qulity of life. The aim of this study was to evaluate the effectiveness of a program to promote Physical, social and cultural activities for 9 months on cardiovascular risk factors and quality of life among older-adults,

Eligibility criteria: Inclusion Criteria:

\* Adults users of 4 Primary Health Care Centers in Catalunya.

Exclusion Criteria:

* Previous episode of ischemic heart disease (\<6 months).
* Outbreak of arthritis with limited ability to ambulate.
* Lung or heart disease with dyspnea mild-moderate efforts.

Primary outcomes:
measure: Physical activity level
timeFrame: At the begining of the intervention and after 9 months.
measure: Cardiovascular risk.
timeFrame: At the begining of the intervention and after 9 months
measure: Biochemical analysis.
timeFrame: At the begining of the intervention and after 9 months.
measure: Antropometric measurements.
timeFrame: At the begining of the intervention and after 9 months.
measure: Frequency of food consumption
timeFrame: At the begining of the intervention and after 9 months.
measure: Health related quality of life
timeFrame: At the begining of the intervention and after 9 months.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Arija V, Villalobos F, Pedret R, Vinuesa A, Jovani D, Pascual G, Basora J. Physical activity, cardiovascular health, quality of life and blood pressure control in hypertensive subjects: randomized clinical trial. Health Qual Life Outcomes. 2018 Sep 14;16(1):184. doi: 10.1186/s12955-018-1008-6.
citation: Arija V, Villalobos F, Pedret R, Vinuesa A, Timon M, Basora T, Aguas D, Basora J; Pas-a-Pas research group. Effectiveness of a physical activity program on cardiovascular disease risk in adult primary health-care users: the "Pas-a-Pas" community intervention trial. BMC Public Health. 2017 Jun 15;17(1):576. doi: 10.1186/s12889-017-4485-3.
Clinical trial NCT03308539: Prediction of Coronary Artery Disease Severity by Epicardial Adipose Tissue Thickness
Official title: Predictive Value of Epicardial Fat Thickness for Disease Severity in Coronary Artery Disease Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myocardial Infarction
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-10-12
Enrollment: 200
Sex: ALL
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: acute myocardial infarction patiens not previously underwent percutaneous coronary angiography or coronary artery bypass grafting

Brief summary: is to test the hypotheses that epicardial adipose tissue can be a marker of severity of coronary artery disease in myocardial infarction patients

Detailed description: epicardial adipose tissue is defined as the adipose tissue between the visceral pericardium and the outer margin of the myocardium which can be considered an endocrine organ that secretes pro-inflammatory and anti-inflammatory cytokines and chemokines including adiponectin.as investigators know, inflammatory response is an important factor in the coronary atherogenesis. Therefore,epicardial adipose tissue is likely to be connected with the severity of coronary artery disease.Recent studies showed that the thickness of the epicardial adipose tissue in patients with coronary artery disease was greater than that with normal coronary arteries.

epicardial adipose tissue will be assessed using transthoracic echocardiography and cardiac magnetic resonance which allows for an accurate volumetric quantification of epicardial fat.

Eligibility criteria: Inclusion Criteria

1. Normal thoracic shape
2. Sinus rhythm
3. without severe respiratory diseases

Exclusion Criteria:

1. contraindication for cardiac magnetic resonance.
2. Patients who previously underwent coronary artery bypass grafting or percutaneous coronary angiography prior to admission
3. history of chronic kidney disease with glomerular filtration rate \<30 mL/min
4. pericardial and/or pleural effusion.

Primary outcomes:
measure: measurement of epicardial adipose tissue as marker of severity of coronary artery disease in myocardial infarction patients.
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Jacqueline George
state: Single
Study officials:
References:
citation: Desferrioxamine and transfusional iron overload. Lancet. 1978 Mar 4;1(8062):479-80. No abstract available.
Clinical trial NCT00624039: The Effect of Cataract Extraction on the Contractility of Ciliary Muscle
Official title: The Effect of Cataract Extraction on the Contractility of Ciliary Muscle
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Presbyopia
Cataract
Keywords: presbyopia
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2008-02-26
Enrollment: 15
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the changes in the pilocarpine-induced ciliary body movement before and after cataract extraction in order to determine the effect of lens sclerosis on the ciliary muscle contractility.

Detailed description: The functional changes in the ciliary body in presbyopia are not only important in a study of the mechanism for presbyopia but are also a key to various procedures or devices used to restore accommodation. Therefore, it is becoming increasingly important to quantify the in vivo accommodative changes in the aging ciliary muscle with and without a lens. We are going to evaluate the changes in the pilocarpine-induced contractility of the ciliary muscle in eyes with presbyopia before and after cataract extraction using ultrasound biomicroscopy (UBM).UBM will be performed with and without instilling 2 % pilocarpine, as well as before and 2 months after cataract extraction. Images of the ciliary body will be compared visually using Adobe Photoshop 7.0.

Eligibility criteria: Inclusion Criteria:

* Age : same or more than 55 years
* Patients with senile cataract who are going to get cataract surgery

Exclusion Criteria:

* Age : less than 55 years
* Previous ocular disease other than cataract.

Primary outcomes:
measure: ultrasound biomicroscopic findings (ciliary body axial length)
timeFrame: 2 months before and after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Department of Ophthalmology, Samsung Medical Center, Ilwon-dong, Kangnam-gu, Seoul, 135-710, Republic of Korea. E-mail: ckee@skku.edu
name: Changwon Kee, M.D.
role: STUDY_DIRECTOR
References:
citation: Stachs O, Martin H, Kirchhoff A, Stave J, Terwee T, Guthoff R. Monitoring accommodative ciliary muscle function using three-dimensional ultrasound. Graefes Arch Clin Exp Ophthalmol. 2002 Nov;240(11):906-12. doi: 10.1007/s00417-002-0551-2. Epub 2002 Oct 9.