louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01049750: Prevalence and Risk Factors of Erectile Dysfunction in Type 2 Diabetic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetic Patients
Erectile Dysfunction
Keywords: type 2 diabetes mellitus
male
erectile dysfunction
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2010-01-14
Enrollment: 220
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: males with type 2 diabetes mellitus

Brief summary: The investigators evaluated 250 male, type 2 diabetic patients, aged 18-80 years. They will undergo IIEF (International Index of Erectile Function), SAS of Zung (self-rating anxiety state)and SDS of Zung (self-rating depression scale)questionnaires. The investigators will evaluate anthropometric and biochemical parameters, dysautonomic function index, IMT (Intima Media Thickness) index, and fundus oculi examen. Furthermore, the investigators will perform MNSI (Michigan Neuropathy Screening Instrument) and NDS (Neuropathy Disability Score)questionnaires.


Eligibility criteria: Inclusion Criteria:

* type 2 diabetes mellitus

Exclusion Criteria:

* type 1 diabetes mellitus
* \< 18 years old
* anatomic abnormalities of the penis
* patients taking erectile dysfunction therapy at the moment of the enrollment

Primary outcomes:
measure: Prevalence of erectile dysfunction
timeFrame: Baseline (time 0); 3 months; 6 months
measure: Description of erectile disfunction markers
timeFrame: Baseline (time 0); 3 months; 6 months
measure: Evaluation of diabetic neuropathy in patients with erectile dysfunction
timeFrame: Baseline (time 0); 3 months; 6 months
Secondary outcomes:
measure: Metalloproteinases 2 and 9
timeFrame: Baseline (time 0); 3 months; 6 months
measure: Insulin-sensitivity index (HOMA index)
timeFrame: Baseline (time 0); 3 months; 6 months
measure: Glycemic control
timeFrame: Baseline (time 0); 3 months; 6 months
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo
Study officials:
affiliation: University of Pavia - Fondazione IRCCS Policlinico San Matteo - Pavia
name: Giuseppe Derosa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Derosa G, Tinelli C, D'Angelo A, Ferrara G, Bonaventura A, Bianchi L, Romano D, Fogari E, Maffioli P. Glyco-metabolic profile among type 2 diabetic patients with erectile dysfunction. Endocr J. 2012;59(7):611-9. doi: 10.1507/endocrj.ej12-0117. Epub 2012 May 26.
citation: Derosa G, Romano D, Tinelli C, D'Angelo A, Maffioli P. Prevalence and associations of erectile dysfunction in a sample of Italian males with type 2 diabetes. Diabetes Res Clin Pract. 2015 May;108(2):329-35. doi: 10.1016/j.diabres.2015.01.037. Epub 2015 Feb 7.
Clinical trial NCT05252650: Postoperative Pain Management in Cerebral Palsy - Comparative Observational Study"
Official title: Postoperative Pain Management in Pediatric Patients With Cerebral Palsy - Comparative Observational Study"
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain, Postoperative
Lead sponsor: Biruni University
Sponsor class: OTHER
First posted: 2022-02-23
Enrollment: 130
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 130 patients aged 3-15 years with a diagnosis of cerebral palsy, category 2 according to the Classification of the American Society of Anesthesiology (ASA 2), who underwent soft tissue release for knee or ankle flexion contracture of the lower extremity with palliative or reconstructive hip interventions

Brief summary: In this study, our aim is to examine orthopedic interventions, anesthesia method, postoperative pain level and management applied to patients with CP in biruni university hospital.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with cerebral palsy between the ages of 3-15,
* Category 2 according to the Classification of the American Society of Anesthesiology (ASA 2),
* patients undergoing soft tissue release for knee or ankle flexion contracture of the lower extremity with palliative or reconstructive hip interventions

Exclusion Criteria:

* Any child with CP younger than 3 years old and older than 15 years has undergone
* procedures without a specific diagnosis of CP,
* the need for bone surgery,
* requiring both hip, knee and ankle surgery in the same session,
* with autonomic neuropathy,
* Patients with a history of anticholinergic and vasoactive drug use or allergy to amide type local anesthetics

Primary outcomes:
measure: pain score
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Ilke Kupeli
Study officials:
References:
citation: Kim SH, Chun DH, Chang CH, Kim TW, Kim YM, Shin YS. Effect of caudal block on sevoflurane requirement for lower limb surgery in children with cerebral palsy. Paediatr Anaesth. 2011 Apr;21(4):394-8. doi: 10.1111/j.1460-9592.2011.03530.x. Epub 2011 Feb 8.
citation: Ozkan D, Gonen E, Akkaya T, Bakir M. Popliteal block for lower limb surgery in children with cerebral palsy: effect on sevoflurane consumption and postoperative pain (a randomized, double-blinded, controlled trial). J Anesth. 2017 Jun;31(3):358-364. doi: 10.1007/s00540-017-2318-2. Epub 2017 Feb 14.
citation: Evreinov, V. V., & Zhirova, T. A. (2020). Regional anesthetic techniques for hip surgery in children with cerebral palsy. Genij Ortopedii, 26(4), 521-256.
citation: Pedersen LK, Rahbek O, Nikolajsen L, Moller-Madsen B. The revised FLACC score: Reliability and validation for pain assessment in children with cerebral palsy. Scand J Pain. 2015 Oct 1;9(1):57-61. doi: 10.1016/j.sjpain.2015.06.007.
Clinical trial NCT01428050: The Use of a Restrictive Fluid Regimen With Hypertonic Saline for Patients Undergoing Pancreaticoduodenectomy
Official title: Prospective Randomized Controlled Trial on the Use of a Restrictive Fluid Regimen With Hypertonic Saline for Patients Undergoing Pancreaticoduodenectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pancreaticoduodenectomy
Keywords: whipple
hypertonic saline
pancreaticoduodenectomy
fluid restriction
resuscitation strategy
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2011-09-02
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The Whipple operation is a complex surgical procedure involving the removal of the head of the pancreas, bile duct, and a portion of the intestine (duodenum) that is performed for patients who have cancer or some other condition affecting this region of the body. The Whipple operation is associated with a significant complication rate. Previous studies have shown that in a broad range of surgical procedures, using a reduced amount of intravenous fluids along with a special type of fluid called hypertonic saline during and after the procedure can lower complication rates associated with the heart and lungs during recovery from surgery. The purpose of this study is to determine if using a reduced amount of intravenous fluids as well as hypertonic saline (a salt concentrated form of intravenous fluids) during the Whipple operation and in the immediate period after surgery can reduce complications.


Eligibility criteria: Inclusion Criteria:

* Physiologic suitability for major abdominal surgery
* Aged 18 years and older
* Written informed consent
* Ability to understand and comply with study guidelines
* Ability to obtain a central venous line

Exclusion Criteria:

* Metabolic acidosis
* Active Sepsis or Bacteremia
* Chronic renal insufficiency
* Hyponatremia (serum sodium \<130)
* Hypernatremia (serum sodium \>150)
* Pregnancy
* Sickle cell anemia
* Pediatric patients
* BMI\>40

Primary outcomes:
measure: Anastomotic Leak
timeFrame: 30 days
measure: Delayed Gastric Emptying
timeFrame: 30 days
measure: Myocardial Infarction
timeFrame: 30 days
measure: Pneumonia
timeFrame: 30 days
measure: Wound Infection
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Harish Lavu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lavu H, Sell NM, Carter TI, Winter JM, Maguire DP, Gratch DM, Berman RA, Feil MG, Grunwald Z, Leiby BE, Pequignot EC, Rosato EL, Yeo CJ. The HYSLAR trial: a prospective randomized controlled trial of the use of a restrictive fluid regimen with 3% hypertonic saline versus lactated Ringers in patients undergoing pancreaticoduodenectomy. Ann Surg. 2014 Sep;260(3):445-53; discussion 453-5. doi: 10.1097/SLA.0000000000000872.
Clinical trial NCT02687750: Testing of Radiofrequency Coil for Clinical 19F MRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diagnostic Imaging
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2016-02-22
Enrollment: 4
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Testing of a dual tuned proton/fluorine MRI radio frequency coil

Images were collected from plastic fluorine phantoms taped to the upper thigh of health volunteers.

This trial was performed as part of an application for a Health Canada Investigational Device Exemption (Protocol # 226949)


Eligibility criteria: Inclusion Criteria:

* Healthy Volunteer

Exclusion Criteria:

* MRI incompatible patient
* claustrophobia

Primary outcomes:
measure: Verify radio frequency coil imaging functionality on humans
timeFrame: 1 hour of scanning
measure: Measure signal repeatability in different patients
timeFrame: 1 hour of scanning
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03563638: Maternal Serum Pentraxin 3 in Early Pregnancy to Predict Gestational Diabetes Mellitus
Official title: Maternal Serum Pentraxin 3 in Early Pregnancy to Predict Gestational Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Complications Affecting Fetus (Diagnosis)
Lead sponsor: Shanghai First Maternity and Infant Hospital
Sponsor class: OTHER
First posted: 2018-06-20
Enrollment: 824
Sex: FEMALE
Minimum age (years): 27
Maximum age (years): 33
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: chinese women with maternal age ≥ 18 years, singleton pregnancy, primipara, no smoking, confirmed gestation≤20 weeks and spontaneous conception

Brief summary: To investigate the association of maternal serum concentrations of pentraxin 3 in early pregnancy with gestational diabetes mellitus and to explore its potential value in the prediction of GDM.

Detailed description: We recruited all pregnant women for the first checkup in our hospital . Maternal fasting serum PTX3 levels, fasting plasma glucose and fasting insulin and other factors were measured. Oral glucose tolerance test (OGTT) was performed at 24-28 weeks in all participants. According to the occurrence of GDM, subjects were divided into two groups: GDM group and normal glucose tolerance (NGT) group.

Eligibility criteria: Inclusion Criteria:

* Women with maternal age ≥ 18 years, singleton pregnancy, primipara, no smoking, confirmed gestation≤20 weeks and spontaneous conception were invited to participate in the study.

Exclusion Criteria:

* Women were excluded if they had multiple pregnancy, pre-gestational diabetes mellitus (PGDM), hypertensive disorders, preterm delivery, cardiovascular disease, immunological disease, glucocorticoid therapy, or other severe illness. In addition, women who were suffering from fetal abnormalities including chromosomally abnormal fetuses and/or structural defects and fetal growth restriction occurred during pregnancy were also excluded from the study.

Primary outcomes:
measure: Serum PTX3 levels in early pregnancy
timeFrame: 2015.10.01-2015.11.31
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00964938: Multisite Pacing With a Quadripolar Lead
Official title: Multisite Pacing With a Quadripolar Left Heart Lead in Cardiovascular Resynchronization Therapy (CRT) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure
Keywords: Hemodynamic response
Cardiac resynchronization therapy
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2009-08-25
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the effects of multisite left ventricular (LV) biventricular (BiV) pacing on LV hemodynamics in CRT patients. It is hypothesized that the effect of simultaneous BiV pacing utilizing multisite LV pacing on LV hemodynamics will be superior to conventional BiV pacing.


Eligibility criteria: Inclusion Criteria:

* Have a scheduled CRT implantation at the participating clinical study site
* Have NYHA functional class III or IV, ejection fraction less than or equal to 35%, and QRS duration greater than 120ms
* Be undergoing a new St. Jude Medical CRT-D device system (including LV lead) implantation
* Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed perioperative evaluations

Exclusion Criteria:

* Have persistent or permanent atrial fibrillation
* Have an intrinsic heart rate of \<50 beats per minute
* Have a recent myocardial infarction within 40 days prior to enrollment
* Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures
* Have had a recent CVA or TIA within 3 months prior to enrollment
* Have had intravenous inotropic support in the last 30 days
* Have ischemic etiology and are unable to tolerate stress echocardiography

Primary outcomes:
measure: dP/dt max
timeFrame: acute: during implant procedure; 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
Study officials:
affiliation: Montreal Heart
name: B Thibault
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thibault B, Dubuc M, Khairy P, Guerra PG, Macle L, Rivard L, Roy D, Talajic M, Karst E, Ryu K, Paiement P, Farazi TG. Acute haemodynamic comparison of multisite and biventricular pacing with a quadripolar left ventricular lead. Europace. 2013 Jul;15(7):984-91. doi: 10.1093/europace/eus435. Epub 2013 Feb 27.
Clinical trial NCT06384638: Coconut Oil in Treatment of Periodontitis
Official title: Efficacy of Locally Delivered Coconut Oil in Management of Stage II and III Grade B Periodontitis. A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Periodontal Diseases
Keywords: Periodontitis
coconut oil
scaling and debridement
Lead sponsor: Misr University for Science and Technology
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 34
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Virgin Coconut Oil (VCO) is a vegetable oil extracted from coconut fleshcontains unsaturated fatty acids in the form of oleic acid and linoleic acid and flavonoids which function as anti-inflammatory. Periodontitis is an inflammatory disease of the periodontal tissues with a high prevalence worldwide. The main etiology of plaque periodontitis is biofilm containing colonies of pathogenic microorganisms. The aim of the study is to evaluate and compare the effect of scaling and root debridement alone versus the use of topically applied coconut oil as adjunctive to scaling and root debridement in treatment of Stage II and III Grade B periodontitis.


Eligibility criteria: Inclusion Criteria:

* patients age group \>35 years without ant systemic disease
* Willing to take part in the study. Patients with more than 16 natural teeth and have test teeth with both mesial and distal neighboring teeth with periodontitis with clinical attachment loss \>3 mm and radiographic percentage of bone loss/age ranged between 0.25 to 1.
* Patients with no history of allergies to coconut

Exclusion Criteria:

* smokers
* pregnant
* lactating women
* Teeth with both endodontic-periodontal lesion.

Primary outcomes:
measure: clinical parameters
timeFrame: 3 months
measure: clinical parameters
timeFrame: 3 months
Secondary outcomes:
measure: Biological parameters
timeFrame: 3 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of dentistry at MUST
Study officials:
References:
Clinical trial NCT04476238: Inosine Energy Expenditure Study
Official title: Randomized Cross-over Trial to Investigate the Effect of Inosine on Human Energy Expenditure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: Energy expenditure
metabolism
inosine
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Investigators want to test whether the intake of the nucleoside inosine increases the human energy expenditure. Inosine occurs as a metabolic intermediate in the human body and is sometimes taken as a dietary supplement by athletes.

For this purpose, investigators will measure the basal metabolic rate by indirect calorimetry. Study participants will then take inosine dissolved in water or placebo and energy expenditure will be assessed again.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers
* BMI between 18-27 kg/m2
* Age between 18 and 40 years

Exclusion Criteria:

* Chronic concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, diabetes mellitus),
* Known or suspected non-compliance, drug or alcohol abuse,
* Inability to follow the procedures of the study
* Participation in another study with investigational drug within the 30 days preceding and during the present study,
* Previous enrolment into the current study,
* Enrolment of the investigator, his/her family members, employees and other dependent persons,
* Thyroid disorders

Primary outcomes:
measure: resting energy expenditure after Inosine
timeFrame: one hour after oral intake of inosine
Secondary outcomes:
measure: Change in energy expenditure
timeFrame: one hour after oral intake of inosine
measure: Change in Respiratory Quotient
timeFrame: one hour after oral intake of inosine
measure: Serum inosine level
timeFrame: 0 hours, 1 hour, 2 hours
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Department of Endocrinology
state: BS
Study officials:
References:
Clinical trial NCT01968538: Metabolomic Study for Localized Prostate Cancer
Official title: A Pilot Study to Establish a Standardized Protocol for Omic Analysis of Patients With Clinically Localized Prostate Cancer Receiving Radiation Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2013-10-24
Enrollment: 400
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 200 prostate cancer patients vs. 200 healthy men

Brief summary: Prostate cancer is a common disease in men treated using surgery, radiation therapy and/or hormonal therapy. Clinical prognosis relates to stage and grade of disease. Recent advances in omic analysis may offer additional information to the physician about prognosis and radiation response. We propose to establish a protocol to incorporate omic analysis into the evaluation and treatment of patients with prostate cancer.


Eligibility criteria: Inclusion Criteria:

* Males who are older than 18 years old,
* with clinically localized prostate cancer
* are receiving radiation therapy

Exclusion Criteria:

* none

Primary outcomes:
measure: molecular changes in biofluid
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Arlington
country: United States
facility: Georgetown University Hospital
state: Virginia
Study officials:
affiliation: Georgetown University Hospital
name: Sean P Collins, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01057238: Intensive Communication for Chronically Critically Ill
Official title: Intensive Communication for Chronically Critically Ill
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Care
Keywords: mechanical ventilation
critical care
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
First posted: 2010-01-27
Enrollment: 571
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was a trial of a formal system of family meetings to support family decision makers of chronically critically ill patients in the intensive care unit.

Detailed description: Formal family meetings have been recommended as a useful approach to assist in goal setting, facilitate decision making, and reduce use of ineffective resources in the ICU. We implemented an "intensive communication system" to test the effect of regular, structured formal family meetings on patient outcomes among long-stay ICU patients

The design was a pre-post, tandem assignment of patients (n=217) receiving usual care and communication, followed by enrollment of intervention patients (n=354), from 5 ICUs. The "intensive communication system" included: (1) family meeting within 5 days of ICU admission and weekly thereafter; (2) each meeting addressed medical update, values and preferences, goals of care; treatment plan, and milestones for judging effectiveness of treatment.

We measured differences between control and intervention patients in indicators of aggressiveness of care or timing of treatment limitation decisions (ICU mortality, LOS, duration of ventilation, treatment limitation orders, or use of tracheostomy or percutaneous gastrostomy). Difference in outcomes among patients who died or who had treatment limitation orders, comparing control and intervention groups, was also examined.

Eligibility criteria: Inclusion Criteria:

* cognitively impaired mechanical ventilation \>3 days not expected to be discharged before 5 days having a family decision maker

Exclusion Criteria:

* no family member hospice referral

Primary outcomes:
measure: length of stay and depression
timeFrame: ICU admission, Day 5, discharge, and 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hosptials Case Medical center
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Barbara J Daly, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Daly BJ, Douglas SL, O'Toole E, Gordon NH, Hejal R, Peerless J, Rowbottom J, Garland A, Lilly C, Wiencek C, Hickman R. Effectiveness trial of an intensive communication structure for families of long-stay ICU patients. Chest. 2010 Dec;138(6):1340-8. doi: 10.1378/chest.10-0292. Epub 2010 Jun 24.