louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00749268: AbsorbaTack Evaluation of Postoperative Pain Following Laparoscopic Hernia Repair
Official title: Evaluation of Postoperative Pain Following Laparoscopic Hernia Repair: A Prospective, Randomized Comparison to Evaluate the Incidence of Post-operative Pain Associated With Absorbable Fixation (AbsorbaTack) vs Conventional Fixation (ProTack) Following Laparoscopic Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hernia, Inguinal
Hernia, Ventral
Keywords: hernia
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2008-09-09
Enrollment: 216
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: The objective of this study is to assess pain that occurs following hernia repair that is related to mesh fixation. The study is designed to see if there is any difference in pain after surgery between absorbable and permanent methods of mesh fixation in inguinal and ventral hernia repair.


Eligibility criteria: Inclusion Criteria:

* Ability and willingness to provide written informed consent and comply with the schedule of protocol assessments
* Age \> 18 years
* Subjects undergoing laparoscopic hernia repair with Parietex or Parietex Composite reinforcements depending on indication and fixation of reinforcements with helical tackers (ProTack, Covidien) or absorbable tacks (AbsorbaTack, Covidien) in accordance with recommendations for use

Exclusion Criteria:

* Pregnancy
* Patients considered to have greater than reasonable surgical risk associated with general anesthesia and laparoscopic hernia repair
* Known active infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics or oral antibiotics within 30 days prior to screening
* History of alcohol or drug abuse within 6 months prior to screening
* History of chronic pain condition requiring more than 30 days of medical management
* Use of an additional nonresorbable means of fixation (inguinal)
* Patients considered not able to comply with the protocol and follow up schedule
* ASA grade of 4 or above

Primary outcomes:
measure: Postoperative Pain
timeFrame: Discharge, Month 1, Month 6, Month 12
measure: Safety for Laparoscopic Hernia Repair as Measured by Number of Patients Experiencing Device Related Events
timeFrame: One year
Secondary outcomes:
measure: Quality of Life
timeFrame: Pre-op, Month 1, Month 6, 1 year
measure: Hernia Recurrence
timeFrame: Discharge, 1 Month, 6 Month, 1 year
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals at Case Medical Center
state: Ohio
city: Greenville
country: United States
facility: Greenville Hospital System
state: South Carolina
Study officials:
affiliation: Case Medical Center, University Hospitals of Cleveland, Cleveland, OH, USA
name: M Rosen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05030168: Effects of Low Protein Diet Supplemented With Ketoanalogues on Preservation of Kidney Function in Incremental Dialysis
Official title: The Effects of Low Protein Diet Supplemented With Ketoanalogues on Preservation of Residual Kidney Function Among Patients Undergoing Incremental Dialysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Kidney Function
Hemodialysis
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2021-09-01
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: The investigators hypothesized that combination of incremental hemodialysis and ketoanologues will better preserve residual kidney function and maintenance of nutritional status among the incident ESRD patients during the early initiation of chronic dialysis. This hypothesis has been a new concept of chronic hemodialysis initiation for End stage renal disease (ESRD) patients

Detailed description: The investigators plan to conduct the first randomized Phase IIA clinical trial to investigate the efficacy of incremental hemodialysis and moderately low protein diet combined with ketoanologues supplementation on preservation of residual kidney function, inflammatory status and nutritional parameters among incident chronic dialysis patients

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years at screening
* Stable CKD stage 5 not yet on dialysis with residual kidney function 5-10 ml/min/1.73m2 by CKD-EPI equation
* Urine output ≥ 800 ml/day
* Willing to participate in the study and can provide inform consent

Exclusion Criteria:

* Rapid glomerular filtration rate (GFR) progression defined as a decline of eGFR \>10 ml/min/1.73m2 by CKD-EPI equation in the prior 6 months before enrollment
* Presence of wasting diseases, cancer cachexia, tuberculosis, AIDS wasting syndrome
* Other active infection/inflammation determined by CRP \>10 mg/L
* Severe gastrointestinal problem: persistent nausea/vomiting, dysphagia, chronic diarrhea, severe malabsorption
* Conditions at baseline requiring withdrawal from the study including severe protein energy wasting by SGA and MIS score, prior kidney transplantation with immunosuppressive agents or other serious medical conditions.
* Pregnancy
* Uncontrolled hypercalcemia (persistent serum Ca ≥10.5 mg/dl)
* BMI ≥ 35 kg/m2
* Hypersensitivity to the active substances or to any of the excipients of Ketosteril
* Disturbed amino acid metabolism

Primary outcomes:
measure: residual renal function
timeFrame: 12 months
Secondary outcomes:
measure: visceral protein
timeFrame: 12 months
measure: structural protein
timeFrame: 12 months
measure: muscle function
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03825068: Erector Spinae Plane Block in Minimal Invasive Cardiac Surgery
Official title: Erector Spinae Plane Block in Minimal Invasive Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Studying the effect of erector spinae plane block in patients undergoing minimal invasive cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* elective valve replacement

Exclusion Criteria:

* chroic renal failure
* chronic liver failure

Primary outcomes:
measure: VAS
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References:
Clinical trial NCT00910468: Robot-Assisted Laparoscopic Myomectomy Is an Improvement Over Laparotomy in Patients With a Limited Number of Fibroids
Official title: Robot-Assisted Laparoscopic Myomectomy Is an Improvement Over Laparotomy in Patients With a Limited Number of Fibroids
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibroid Uterus
Lead sponsor: Ascher-Walsh, Charles, M.D.
Sponsor class: INDIV
First posted: 2009-05-29
Enrollment: 150
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with fibroid uterus desiring surgical management

Brief summary: This is a retrospective, case-control study of 75 patients having undergone a robotic-assisted laparoscopic myomectomy were compared to patients having undergone myomectomy via laparotomy. Both groups had 3 or fewer fibroids confirmed by pre-operative MRI or on final pathology report. Charts were reviewed for surgical and post-operative variables


Eligibility criteria: Inclusion Criteria:

* uterus less than or equal to 20 weeks in size by office exam and no greater than three intramural fibroids on pre-operative MRI.

Exclusion Criteria:

* significant medical problems limiting their ability to undergo a prolonged laparoscopic procedure and could not have had previous uterine surgery.

Primary outcomes:
measure: Post-operative variables, including estimated blood loss, length of stay, days to a regular diet and febrile morbidity
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount SInai School of Medicine
state: New York
Study officials:
affiliation: Mt Sinai School of Medicine, Dept Obstetrics and Gynecology
name: Charles Ascher-Walsh, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05559268: Effects of Denosumab on Bone Microarchitecture After Total Knee Arthroplasty
Official title: Single Dose Subcutaneous Injections of Denosumab for Patients Underwent Cemented Total Knee Arthroplasty. A Randomized Controlled Study on the Effects on Bone Microarchitecture, Skeletal Muscle, Cartilage and Synovium
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2022-09-29
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates single dose of Denosumab in decreasing systemic and periprosthetic bone resorption after Total Knee Arthroplasty compared to placebo in 60 patients (30 placebo and 30 Denosumab) within 2 months after surgery. This study also evaluates the anti-RANKL effect of single dose of Denosumab in serum, skeletal muscle, synovium, fat, and cartilage.


Eligibility criteria: Inclusion Criteria:

Patients with Bilateral Knee Osteoarthritis treated with Staged Bilateral Total Knee Arthroplasty, with an Interval of 8 weeks

Exclusion Criteria:

Patients allergies to Denosumab Patients with previous Osteoporosis treatment Patients with renal failure Patients with previous Bisphosphonate treatment for more than 5 years Patients failed to finish contralateral Total Knee Arthroplasty at 8 weeks

Primary outcomes:
measure: Bone Microarchitecture
timeFrame: 8 weeks
measure: Bone turnover markers
timeFrame: 8 weeks
Secondary outcomes:
measure: intermuscular and intramuscular adipose
timeFrame: 8 weeks
measure: Mankin Histological-Histochemical Grading of Cartilage
timeFrame: 8 weeks
measure: Histopathological grading of synovium
timeFrame: 8 weeks
Other outcomes:
measure: Certain protein expression in bone, muscle, synovium and cartilage
timeFrame: 8 weeks
Locations:
Study officials:
References:
Clinical trial NCT00035568: A Research Study to Assess the Mechanism By Which Glucovance, Metformin, and Glyburide Work To Control Glucose Levels In Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Keywords: Type 2 Diabetes Mellitus
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2002-05-06
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical research study is to support earlier observations that Glucovance controls glucose levels after a mean, and improves overall glucose control better than metformin or glyburide therapy alone in adults with type 2 diabetes.


Eligibility criteria: Adults 20-75 with a diagnosis of type 2 diabetes mellitus who are not adequately controlled with diet and exercise, and have an HbA1c greater than 6.7%

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Local Institution
state: Arkansas
city: Los Angeles
country: United States
facility: Local Institution
state: California
city: Chicago
country: United States
facility: Local Institution
state: Illinois
city: Indianapolis
country: United States
facility: Local Institution
state: Indiana
city: Brooklyn
country: United States
facility: Local Institution
state: New York
city: Rochester
country: United States
facility: Local Institution
state: New York
city: Pittsburgh
country: United States
facility: Local Institution
state: Pennsylvania
city: Dallas
country: United States
facility: Local Institution
state: Texas
city: San Antonio
country: United States
facility: Local Institution
state: Texas
Study officials:
References:
citation: Gnesin F, Thuesen ACB, Kahler LKA, Madsbad S, Hemmingsen B. Metformin monotherapy for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Jun 5;6(6):CD012906. doi: 10.1002/14651858.CD012906.pub2.
Clinical trial NCT00871468: Plating Clavicle Fractures
Official title: Does Anterior-Inferior Clavicle Plating Have a Lower Rate of Soft Tissue Irritation Compared to Superior Plating? A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Clavicle Fracture, Non Union/Malunion
Lead sponsor: United States Army Institute of Surgical Research
Sponsor class: FED
Collaborators: name: William Beaumont Army Medical Center
First posted: 2009-03-30
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The anterior-inferior clavicle plate position will have a lower rate of soft tissue irritation that limits activity and/or requires hardware removal compared to superior plate position.

Detailed description: Compare the rates of soft-tissue irritation with two different methods of plating for clavicle fractures. Patients will be randomized to anterior-inferior or superior plating. Validated shoulder scoring systems will be used to assess outcome. Specific follow-up questions will address the patient's ability to wear his/her uniform, body armor, ruck sack, and other shoulder-borne equipment over the surgical site.

Eligibility criteria: Inclusion Criteria:

* Active duty, Reservists, National Guard service members
* completely displaced shaft fracture of the clavicle (no cortical contact between the main proximal and distal fragments)
* a fracture involving the middle third of the clavicle (a fracture amenable to plate fixation with a minimum of three screws in each proximal and distal fragment)
* chronic nonunion and malunion fractures
* no medical contraindications to general anesthesia
* provided informed consent.

Exclusion Criteria:

* an age of less than eighteen years or greater than sixty five years
* a fracture in the proximal or distal third of the clavicle not amenable to plating
* a pathological fracture
* an associated head injury (a Glasgow Coma Scale score of \<15 at 21 days after injury)
* an inability to comply with followup
* a medical contraindication to surgery and/or anesthesia (such as heart disease, renal failure, or active chemotherapy)
* a lack of consent.

Primary outcomes:
measure: Less irritation with anterior-inferior plating and less need for hardware removal.
timeFrame: 2 years
Secondary outcomes:
measure: DASH (Disability of Arm, Shoulder and Hand) and constant scores
timeFrame: 2 years
Other outcomes:
Locations:
city: El Paso
country: United States
facility: William Beaumont Army Medical Center
state: Texas
city: Fort Sam Houston
country: United States
facility: US Army Institute of Surgical Research
state: Texas
Study officials:
References:
Clinical trial NCT03957668: Efficacy and Safety of PEG 3350 for Treatment of Chronic Constipation
Official title: Efficacy and Safety of PEG 3350 for Treatment of Chronic Constipation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Constipation - Functional
Keywords: PEG 3350
Constipation
Lead sponsor: Fakultas Kedokteran Universitas Indonesia
Sponsor class: OTHER
Collaborators: name: PT Meiji Indonesia
First posted: 2019-05-21
Enrollment: 184
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: The aim of this study is to determine the efficacy and safety of PEG 3350 (polyethylene glycol 3350) for short-term treatment of chronic constipation in adults.


Eligibility criteria: Inclusion Criteria:

1. Males and females aged ≥ 18 years.
2. Body Mass Index (BMI) ≥ 18.5
3. Organic bowel disease will be ruled out by Fecal Immunochemical Test (FIT) and/or colonoscopy.
4. Must have ≤ 2 bowel movements during a 7-day qualification period.
5. In otherwise good health as judged by a physical examination and laboratory testing.
6. Not taking medications known to affect bowel function in one week before study.
7. Willing to participate in the study by signing the informed consent.

Exclusion Criteria:

1. Hypersensitive to the study medication.
2. obstructive ileus.
3. Irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD)

Primary outcomes:
measure: Change of number of bowel movements at 1 week
timeFrame: 7 days
measure: Change of number of bowel movements at 2 weeks
timeFrame: 14 days
Secondary outcomes:
measure: Symptom scores at 1 week
timeFrame: 7 days
measure: Symptom scores at 2 weeks
timeFrame: 14 days
measure: Overall rating of effectiveness at 1 week
timeFrame: 7 days
measure: Overall rating of effectiveness at 2 weeks
timeFrame: 14 days
Other outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: 7 days, 14 days
measure: Number of participants with serious adverse events (SAEs)
timeFrame: 7 days, 14 days
Locations:
city: Jakarta
country: Indonesia
facility: Puskesmas Kelurahan Petamburan
state: DKI Jakarta
city: Jakarta
country: Indonesia
facility: RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)
state: DKI Jakarta
city: Jakarta
country: Indonesia
facility: Puskesmas Kelurahan Paseban
state: DKI Jakarta
Study officials:
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Murdani Abdulah
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02410668: The Effects of Flaxseed Supplement on Weight and Biochemical Factors in Overweight and Obese Subject
Official title: The Effects of Flaxseed Supplement on Weight, Lipid Profile and Inflammatory Factors in Overweight and Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Overweight and Obesity
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2015-04-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the effects of Flaxseed supplement on weight, lipid profile and inflammatory factors in subjects with over weight and obesity, 50 patients will be randomly allocated to receive placebo or 30 grams milled Flaxseed for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. At the first and the end of the intervention, weight, waist and hip circumference, lipid profile and some inflammatory markers will be assessed and compared between groups.


Eligibility criteria: Inclusion Criteria:

* Age of 18 to 70 years
* Body Mass Index (BMI) between 25-40

Exclusion Criteria:

* diabetes mellitus
* cardiovascular diseases and cancers
* major systemic diseases
* gastrointestinal problems
* liver and renal failure
* history of allergy or high consumption of nuts, flaxseed, or sesame seeds
* weight loss within the past 6 mo of \>5% of body weight or current adherence to a weight-reduction diet
* pregnancy, lactation

Primary outcomes:
measure: weight
timeFrame: 12 weeks
measure: waist and hip circumference
timeFrame: 12 weeks
Secondary outcomes:
measure: lipid profile
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Yari Z, Rahimlou M, Poustchi H, Hekmatdoost A. Flaxseed supplementation improves anthropometric measurements, metabolic, and inflammatory biomarkers in overweight and obese adults. Int J Vitam Nutr Res. 2022 Jul;92(3-4):161-168. doi: 10.1024/0300-9831/a000565. Epub 2019 Mar 7.
Clinical trial NCT02336568: The Effect of 21-Days Intranasal Oxytocin on Patients With Post Traumatic Stress Disorder (PTSD)
Official title: The Effect of 21-Days Intranasal Oxytocin on Clinical Symptoms and Social Function in Patients With Post Traumatic Stress Disorder (PTSD), a Randomized Controled Trail
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: PTSD
Keywords: PTSD, Oxytocin
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2015-01-13
Enrollment: 40
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: Oxytocin (OT) - a neurohormone and neuromodulator which is mainly synthesized in the hypothalamus - is a mediator stress regulation and improves social bonding. Recently, several theoretical studies suggested that PTSD patients have abnormal functioning of the OT system. According to these theories, dysfunction in the oxytocin system may modulate the interpersonal impairment that characterizes PTSD, and therefore intranasal OT may potentially relieve these symptoms. In two current studies that were conducted in Rambam health care we found that a single dose of intranasal OT reduces anxiety and irritability symptoms, and enhances emotional empathy and compassion, in patients with PTSD. The main goal of this study is to examine the effects of 21-days intranasal Oxytocin on clinical symptoms and social function in these patients.

Detailed description: This study will examine the effect is of 21-days intranasal Oxytocin on clinical symptoms and social function in these patients, in a double blind (treatment/placebo) study design.

Eligibility criteria: Inclusion Criteria:

* PTSD patients (DSM-IV criteria)
* Ability to provide written informed consent

Exclusion Criteria:

* Suicidality
* Psychosis
* Borderline Personality
* Arrhythmia
* Cardiac disease (arrythmia, heart failure)
* Hyponatremia
* Hypertension
* Severe renal insufficiency
* Liver cirrhosis
* Lactating or pregnant women, or undergoing fertility treatment

Primary outcomes:
measure: Semi-structured interviews (CAPS)and self-report questionnaires that examine the symptoms of the disorder and related symptoms (social function and aggressive behavior)
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: