louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00041743: Treatment of Binge Eating Disorder
Official title: Treatment of Binge Eating Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Binge Eating Disorder
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2002-07-17
Enrollment: 200
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: This is a study examining the use of different degrees of therapist involvement in the treatment of Binge Eating Disorder. The study will examine both which approaches work best for decreasing symptoms and which are most cost-effective.


Eligibility criteria: * Binge Eating Disorder
* Age 18-65, Male or Female
* Not Currently receiving psychotherapy
* Not currently in Formal weight loss treatment
* No current unstable medical problems
* No history of Bipolar illness or Schizophrenia
* Overweight or Obese (body mass index 25-45)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: Universtiy of Minnesota
name: Scott J Crow, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pacanowski CR, Mason TB, Crosby RD, Mitchell JE, Crow SJ, Wonderlich SA, Peterson CB. Weight Change over the Course of Binge Eating Disorder Treatment: Relationship to Binge Episodes and Psychological Factors. Obesity (Silver Spring). 2018 May;26(5):838-844. doi: 10.1002/oby.22149. Epub 2018 Mar 13.
citation: Pisetsky EM, Durkin NE, Crosby RD, Berg KC, Mitchell JE, Crow SJ, Wonderlich SA, Peterson CB. Examination of early group dynamics and treatment outcome in a randomized controlled trial of group cognitive behavior therapy for binge eating disorder. Behav Res Ther. 2015 Oct;73:74-8. doi: 10.1016/j.brat.2015.07.013. Epub 2015 Jul 31.
citation: Peterson CB, Mitchell JE, Crow SJ, Crosby RD, Wonderlich SA. The efficacy of self-help group treatment and therapist-led group treatment for binge eating disorder. Am J Psychiatry. 2009 Dec;166(12):1347-54. doi: 10.1176/appi.ajp.2009.09030345. Epub 2009 Nov 2.
Clinical trial NCT02995343: Evaluation of the Ovarian Reserve in Patients Who Hypogastric Arteries and or Uterine Arteries Had Been Ligated
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ovarian Reserve
Hypogastric Artery Ligation
Uterine Artery Ligation
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2016-12-16
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Patients who hypogastric arteries and/or uterine arteries had been ligated will be evaluated in terms of ovarian reserve markers such as anti-mullerian hormone levels, ovarian volumes, antral follicule count, follicule stimuli hormone and estrogen levels. Investigators will search their archives for finding suitable patients for study. Investigators will especially notice being at least 6 month time of interval between surgery and evaluation time. Ultrasound examination and taking blood sample will be performed on 2nd or 3th day of menstrual cycle. These results will be compared with normal postpartum women's results. It will be evaluated that there is or not any effect of the hypogastric arteries and/or uterine arteries on ovarian reserve


Eligibility criteria: Inclusion Criteria:

* Patients had been ligated hypogastric and/or uterine arteries
* Patients are in 6 month period after surgery
* Without performed hysterectomy
* No older than 40 years old
* No history about endocrinopathy which have an effect upon ovarian reserve

Exclusion Criteria:

* Patients had been made other gynecologic surgery such as fallopian tube ligation and hysterectomy etc.
* Patients are older than 40 years old
* Patients use drugs which have an effect upon ovarian reserve
* Patients have diseases which have an effect upon ovarian reserve such as some endocrinopathy, malign diseases which require radiotherapy and chemotherapy etc.

Primary outcomes:
measure: Anti-mullerian hormone levels will be evaluated
timeFrame: 6 months after surgery and delivery
measure: Antral Follicule Count will be evaluated
timeFrame: 6 months after surgery and delivery
measure: Ovarian volume will be evaluated
timeFrame: 6 months after surgery and delivery
measure: Follicule Stimuli Hormone levels will be evaluated
timeFrame: 6 months after surgery and delivery
measure: Estrogen levels will be evaluated
timeFrame: 6 months after surgery and delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ege University, Medicine Faculty, Department of Obstetrics and Gynecology
Study officials:
References:
Clinical trial NCT06591143: Evaluation Of Periodontal Health After Treatment With Hall Technique Versus Atraumatic Restorative Treatment in The Management of Carious Primary Molars
Official title: Evaluation Of Periodontal Health After Treatment With Hall Technique Compared to Atraumatic Restorative Treatment in The Management of Carious Primary Molars: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Decayed Primary Molars
Keywords: Decayed primary molars ART Hall technique
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 46
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial seeks to evaluate the periodontal health of two modalities Hall Technique (by placing a stainless steel crown without caries removal, local anaesthesia won't be needed) \&amp; ART (by removing caries by sharp excavator and restoring the tooth with glass ionomer, local anaesthesia won't be needed either) to achieve better treatment for caries with pain-free procedures in developing countries that have high caries index and low income.


Eligibility criteria: Inclusion Criteria:

* Age: From 4 to 6 years.
* Caries in primary molars within enamel/dentin with vital pulp.
* Healthy children.
* Cooperative children.

Exclusion Criteria:

* Presence of signs and symptoms of necrosis.
* Root caries.
* History of Spontaneous pain.

Primary outcomes:
measure: Periodontal health
timeFrame: initial, 3 months, 6 months, 12 months
Secondary outcomes:
measure: Gingival index
timeFrame: Initial, 3 months, 6 months, 12 months
measure: Postoperative pain and discomfort
timeFrame: Immediately postoperative
measure: Child behaviour
timeFrame: Intraoperative
measure: Child anxiety
timeFrame: Intraoperative
measure: Canine overbite
timeFrame: Initial, 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
Study officials:
References:
Clinical trial NCT05595343: Learning Curves in Laparoscopic Distal Pancreatectomy: A Different Experience for Each Generation
Official title: Learning Curves in Laparoscopic Distal Pancreatectomy: A Different Experience for Each Generation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Lead sponsor: Fondazione Poliambulanza Istituto Ospedaliero
Sponsor class: OTHER
Collaborators: name: Amsterdam UMC, location VUmc
First posted: 2022-10-26
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data of all consecutive patients who underwent elective LDP by 'pioneering' surgeons and early adopting surgeons in the period 1997-2019 were collected from a retrospective database of centers participating in the European Consortium on Minimally Invasive Pancreatic Surgery (E-MIPS) or International Consortium on Minimally Invasive Pancreatic Surgery (I-MIPS).

Brief summary: This study compared the learning curves and outcome of Laparoscopic Distal Pancreatectomy between 'pioneers' and early adopters in terms of feasibility and proficiency using short term outcomes.

Detailed description: Learning curves of laparoscopic distal pancreatectomy (LDP) are mostly based on 'pioneering' surgeons who acquired sufficient proficiency largely through self-teaching. No learning curves have been investigated for early adopting surgeons who performed surgery in later stages of the IDEAL framework and build on the experience of the 'pioneering' surgeons. This study compared the learning curves and outcome of LDP between 'pioneers' and early adopters in terms of feasibility and proficiency using short term outcomes over a period from 1997-2019.

Eligibility criteria: Inclusion Criteria:

* The collected data included the name of the surgeon so inclusion criteria for participating surgeons could be determined. Surgeons who were experienced with a minimum of 40 LDPs in total with at least 10 LDPs per year and who performed their LDPs in the same institution (i.e. no outside institutions) were included.

Exclusion Criteria:

* None

Primary outcomes:
measure: Feasibility learning curve
timeFrame: 1997-2019
measure: Proficiency learning curve
timeFrame: 1997-2019
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01063543: Pharmacokinetics of Fondaparinux in Patients With Major Orthopedic Surgery
Official title: Population Pharmacokinetics of Fondaparinux Administered at Prophylactic Doses After Major Orthopedic Surgery in Everyday Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orthopedic Surgery
Keywords: fondaparinux
orthopedic surgery
patients with major orthopedic surgery
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2010-02-05
Enrollment: 997
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with major orthopedic surgery who need prophylactic doses of fondaprinux

Brief summary: Fondaparinux is a synthetic antithrombotic agent with specific anti-factor Xa activity. A population pharmacokinetic model of fondaparinux, based on data obtained in patients included in phase II/III trials, has been described. However, the validity of this model in everyday practice needed to be confirmed. This study was a multicenter, prospective cohort study in consecutive orthopedic patients treated with 2.5 mg of fondaparinux. Anti-Xa activities were recorded in 809 patients. Population parameters and inter-individual variability were estimated using NONMEM VI software. A two-compartment model with first-order absorption best described fondaparinux pharmacokinetics. Covariates partly explaining inter-individual variability were body weight, age and creatinine clearance estimated by the simplified Modification of Diet in Renal Disease formula. A body weight less than 50 kg and moderate renal failure increased drug exposure. These results suggest that fondaparinux pharmacokinetics need to be confirmed in patient populations not fully assessed in phase II/III studies


Eligibility criteria: Inclusion Criteria:

* patient who need leg major orthopedic surgery
* age \> 18 years
* patient who need prophylactic doses of fondaparinux

Exclusion Criteria:

* contra-indication to fondaparinux
* renal insufficiency

Primary outcomes:
measure: To determine an anti-Xa activity value which is predicted of a haemorrhage risk
timeFrame: day 9
Secondary outcomes:
Other outcomes:
Locations:
city: Annonay
country: France
facility: CHARRET Françoise
city: Caen
country: France
facility: PEGOIX Michel
city: Paris
country: France
facility: ROSENCHER Nadia
city: Pierre Bénite
country: France
facility: PETIT Pierre-Yves
city: Reims
country: France
facility: BARRE Jeanne
city: Rouen
country: France
facility: MAITRE Anne-Marie
city: Saint-etienne
country: France
facility: BAYLOT Denis
city: Saint-etienne
country: France
facility: ZUFFEREY Paul
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Patrick MISMETTI, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01582243: Safety and Efficacy of Vildagliptin Plus Metformin (SPC) Treatment in Type 2 Diabetes Mellitus Patients
Official title: A Prospective, Open-label, Interventional Study to Assess the HbA1c Change an 24-hr Glucose Fluctuation After Vildagliptin Plus Metformain (SPC) Treatment in Metformin Monotherapy Uncontrolled Type 2 Diabetes Mellitus Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, type 2
vildagliptin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-04-20
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess the efficacy of vildagliptin plus metformin (SPC) treatment in type 2 diabetes mellitus patients uncontrolled by metformin monotherapy after 24 weeks treatment


Eligibility criteria: Inclusion criteria

1. Outpatients who were 20 years of age and older with diagnosis of T2DM.
2. Patients who had been treated with stable dose of metformin (≥1000 mg/day) monotherapy at least 4 weeks prior to Visit 1 and had failed to achieve the glucose control goal. The glucose control goal was defined as HbA1c ≤ 6.5%.
3. Male or female with child-bearing potential agreed to use an effective method of contraception approved by the investigator during the study.
4. Understood the nature of the study, and had signed informed consent form.

Exclusion criteria

1. Patients with contraindications mentioned in the Summary of Product Characteristics for vildagliptin or metformin.
2. Patients with renal dysfunction defined as creatinine clearance \< 60 ml/min at Visit 1.
3. Patients with history of hepatic impairment, including but not limited to those with pretreatment AST or ALT \> 3 ULN at Visit 1.
4. Female patients who needed to lactate during the study.

Primary outcomes:
measure: Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
timeFrame: Baseline, week 12
measure: Mean Change From Baseline in Fasting Plasma Glucose(FPG) at Week 12 and 24
timeFrame: Baseline, week 12, week 24
measure: Mean Change From Baseline in Postprandial Plasma Glucose(PPG) at Week 12 and 24
timeFrame: Baseline, week, week 24
measure: Mean Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) Detected by Continuous Glucose Monitoring System (CGMS) After 24-week
timeFrame: Baseline, week 24
measure: The Percentage of Patients Achieving the Two Glycemic Goals After 12- and 24-week Treatment
timeFrame: week 12, week 24
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT01993238: Evaluation of Procedural Analgesia for Liposonix Treatment
Official title: An Evaluation of Procedural Analgesia for Out-Patient Liposonix Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Contouring
Lead sponsor: Valeant Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-11-25
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objectives of this study are to evaluate the safety and effectiveness of procedural analgesia for improvements in tolerability of treatment with the Liposonix System.


Eligibility criteria: Inclusion Criteria:

* Subject is an adult female or male, 18 to 65 years of age.
* Subject must weigh more than 120 pounds.
* Subject must have a Body Mass Index of ≤ 30 kg/m2.
* Subject must have thickness of skin + subcutaneous adipose tissue in the anticipated treatment area of ≥ 2.3 cm.
* Subject must be able to read, write, speak, and understand English.

Exclusion Criteria:

* Female subject who is pregnant, is suspected to be pregnant, or is lactating
* Subjects diagnosed with coagulation disorders or are receiving anticoagulant therapy or medications or dietary supplements which impede coagulation or platelet aggregation
* Subject has diabetes or cardiovascular disease
* Subject has had any aesthetic procedure to the region to be treated within past 6 months
* Subject has systemic skin disease or skin disease in the area to be treated
* Subject has any abnormality of the skin or soft tissues of the abdominal wall in the area to be treated
* Subject has had previous open or laparoscopic surgery in the anticipated treatment area
* Subjects is on prescription or over the counter weight reduction medication or programs, or had weight reduction procedures
* Subject has skin or superficial tissue that does not lie flat on its own when the subject is in the supine position
* Subjects undergoing chronic steroid or immunosuppressive therapy
* Subjects who have cardiac pacemakers or any implantable electrical device
* Subjects who have metal implants of any type in the area to be treated
* History of cancer
* Subjects who have sensory loss or dysesthesia in the area to be treated
* Subjects taking chronic benzodiazepines or opiates
* Subjects with a history of severe nausea/vomiting with opioid analgesics
* Subjects with sleep apnea
* Subjects with known allergies or sensitivities to study drugs
* Subjects with liver disease
* Subjects with renal failure

Primary outcomes:
measure: Pain Score for Overall Treatment
timeFrame: Baseline
Secondary outcomes:
measure: Safety Assessment
timeFrame: Baseline, 1 day, 1 week
measure: Pain Scores Reported at 1-day Post-Treatment
timeFrame: 1 day
Other outcomes:
Locations:
city: Hayward
country: United States
facility: Solta Medical Aesthetic Center
state: California
Study officials:
name: Ronald Wheeland, MD
role: PRINCIPAL_INVESTIGATOR
name: Reid Rubsamen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01504438: Prospective Randomized Evaluation of a Two and Three Piece Total Ankle Replacement
Official title: Prospective Randomized Evaluation Of A Two And Three Piece Total Ankle Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Osteoarthritis
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2012-01-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized study to prospectively compare and evaluate the functional outcome and patient satisfaction of total ankle replacements for tibio-talar osteoarthritis using either the STAR or Salto-Talaris prothesis.


Eligibility criteria: Inclusion Criteria:

* Adult patients (age \> 18 years) who will benefit from a total ankle replacement, as determined by Drs. Nunley, DeOrio, or Easley, with the aid of the physical exam and routine radiography treated at Duke University Medical Center and who have no medical conditions that would represent contraindications to surgery or anesthesia will be asked to participate in this study.

Exclusion Criteria:

* The only excluded patients will be those who do not choose to participate in this study, have a weight greater than 250lbs, or do not meet the minimum age of 18 years.

Primary outcomes:
measure: Pain Following a Total Ankle Replacement as Measured by the Visual Analog Scale (VAS) for Pain
timeFrame: Baseline, 6 months, 1 year, 2 years, 3 years
measure: Functional Health Following a Total Ankle Replacement Using the 36-Item Short Form Health Survey (SF-36).
timeFrame: Baseline, 6 months, 1 year, 2 years, 3 years
measure: Physical Limitations Following a Total Ankle Replacement as Measured by the Short Musculoskeletal Function Assessment (SMFA) Questionnaire.
timeFrame: Baseline, 6 months, 1 year, 2 years, 3 years
measure: Pain and Function Following a Total Ankle Replacement as Measured by the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Rating System
timeFrame: Baseline, 6 months, 1 year, 2 years, 3 years
measure: To Measure a Change in One's Daily Activity Following a Total Ankle Replacement Using the Foot and Ankle Disability Index (FADI) at Multiple Time Points.
timeFrame: Baseline, 6 months, 1 year, 2 years, 3 years
Secondary outcomes:
measure: Three Dimensional Kinematic and Kinetic Assessment During Level Walking Across Time Following Total Ankle Replacement.
timeFrame: Baseline, 6 months, 1 year, 2 years, 3 years
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Medical Plaza Page Road
state: North Carolina
Study officials:
affiliation: Duke University
name: James A Nunley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02224638: Wound Management for Sacral Pressure Ulcers With Necrotic Tissue
Official title: Evaluation of Wound Management for Sacral Pressure Ulcers With Necrotic Tissue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pressure Ulcers
Keywords: skin ulcers
Lead sponsor: Medline Industries
Sponsor class: INDUSTRY
First posted: 2014-08-25
Enrollment: 21
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single-center, randomized open-label study with multiple application treatment of necrotic sacral or buttocks pressure ulcers with either TheraHoney HD or SkinTegrity Hydrogel.
Primary purpose: TREATMENT

Brief summary: Evaluation of a wound care debridement product and a moisturizer on sacral pressure ulcer wounds

Detailed description: Pressure ulcers on the sacral area will be applied with either a wound debridement product or a wound moisturizer product plus a gentle wound dressing to manage wound closure over a 2-3 week period of treatment.

Eligibility criteria: Inclusion Criteria:

* Male or female subjects of any age
* Sacral wounds with necrotic tissue

Exclusion Criteria:

* 3rd degree burns
* know hypersensitivity to products

Primary outcomes:
measure: Percentage of Wounds Healed
timeFrame: 3 weeks
Secondary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Swedish Covenant Hospital
state: Illinois
city: Chicago
country: United States
facility: Harmony Residential Facility
state: Illinois
Study officials:
affiliation: Swedish Covenant Hospital
name: Nancy Chaiken, RN
role: PRINCIPAL_INVESTIGATOR
References: