louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03428386: Single-Anastomosis Plication Ileal Bypass for Morbid Obesity
Official title: Single-Anastomosis Plication Ileal Bypass in Treatment of Morbid Obesity: a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Morbid Obesity
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2018-02-09
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The present study aims to explore the impact of combining laparoscopic greater curvature plication with a single gastro-ileal anastomosis in the same manner of single anastomosis sleeve ileal bypass on weight loss and postoperative complications. The objective of this combined procedure is to reduce the high intraluminal pressure that results after laparoscopic greater curvature plication owing to reduced intraluminal space which can lead to suture line leakage, vomiting, and gastroesophageal reflux disease. Another objective is to add a malabsorptive element to the restrictive effect of laparoscopic greater curvature plication and to induce early satiety in patients by distention of the distal bowel with nutrients immediately after meals, similar to the way that single anastomosis sleeve ileal bypass works.

Detailed description: The present study aims to explore the impact of combining laparoscopic greater curvature plication with a single gastro-ileal anastomosis in the same manner of single anastomosis sleeve ileal bypass on weight loss and postoperative complications. The objective of this combined procedure is to reduce the high intraluminal pressure that results after laparoscopic greater curvature plication owing to reduced intraluminal space which can lead to suture line leakage, vomiting, and gastroesophageal reflux disease. Another objective is to add a malabsorptive element to the restrictive effect of laparoscopic greater curvature plication and to induce early satiety in patients by distention of the distal bowel with nutrients immediately after meals, similar to the way that single anastomosis sleeve ileal bypass works.

Eligibility criteria: Inclusion Criteria:

* Adult patients of both genders aging between 18 and 60 years with morbid obesity will be included to the study

Exclusion Criteria:

* Patients with secondary obesity due to endocrine disorders
* patient unfit for general anesthesia.
* patients who had not attempted non-surgical weight loss treatment in the past
* patients with psychological conditions that influence his/her perception of the study protocol
* patients with previous surgery for morbid obesity

Primary outcomes:
measure: weight loss
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura university hospital
state: Dakahlia
Study officials:
affiliation: Mansoura University Hospital
name: Sameh H Emile, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00326586: A Phase I Dose-Escalation Study of BMS-641988 in Patients With Castration-Resistant Prostate Cancer
Official title: A Phase I Dose-Escalation Study of BMS-641988 in Patients With Castration-Resistant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-05-17
Enrollment: 54
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a Phase I Dose-Escalation Study of BMS641988 in Patients with Castration-Resistant Prostate Cancer.


Eligibility criteria: Inclusion Criteria:

* Advanced castration-resistant prostate carcinoma with progressive disease
* At least 4 weeks must have elapsed from major surgery
* Patient must be available for follow-up
* Adequate liver and kidney function
* Adequate blood values

Exclusion Criteria:

* Uncontrolled or significant heart disease
* History of seizures
* History of head injury, loss of consciousness, or stroke
* Patients undergoing alcohol withdrawal
* Any concurrent cancer
* A serious uncontrolled medical disorder or active infection
* Inability to swallow tablets

Primary outcomes:
measure: To assess safety and tolerability and to identify a dose for Phase II evaluation
timeFrame: during the dose escalation phase
Secondary outcomes:
measure: To evaluate pharmacokinetics
timeFrame: throughout the study
measure: To describe preliminary evidence of anit-tumor activity
timeFrame: throughout the study
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
state: Maryland
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Madison
country: United States
facility: University Of Wisconsin Hospital And Clinics Laboratory
state: Wisconsin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT05172986: Enhanced Recovery Program After a Robotic-assisted Surgery (RAAC) of Radical Prostatectomy. PROSTA-RAAC
Official title: Enhanced Recovery Program After a Robotic-assisted Surgery (RAAC) of Radical Prostatectomy. PROSTA-RAAC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Quality of Life
Recovery Programm
Keywords: Robotic assisted
Lead sponsor: Elsan
Sponsor class: OTHER
First posted: 2021-12-29
Enrollment: 135
Sex: MALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There are few published data on the benefit of Enhanced recovery program in radical prostatectomy in the management of localized prostate cancer. All the studies available on the subject are retrospective (1-3).

This randomized comparative study is proposed in order to compare in a homogeneous population (place and time) the interest of RAAC specifically in this surgery.

Detailed description: The implementation of RAAC programs in healthcare establishments would improve the quality and safety of patient care (functional development and rapid convalescence of patients and reduction in postoperative morbidity through active prevention of perioperative complications) and optimization of care costs for health establishments and for health insurance (reduction in length of stay and convalescence, reduction in postoperative complications). Its implementation requires a strong involvement of all the teams and a transversal and multidisciplinary coordination, specifically dedicated to one type of intervention. This approach must therefore show its effectiveness by specialty and then by pathology within the same specialty.

There are few published data on the benefit of RAAC in radical prostatectomy in the management of localized prostate cancer. All the studies available on the subject are retrospective (1-3).

This randomized comparative study is proposed in order to compare in a homogeneous population (place and time) the interest of RAAC specifically in this surgery.

Eligibility criteria: Inclusion Criteria:

* Male over 40 and under 75
* Patient scheduled for a robot assisted radical prostatectomy within the center
* Affiliation to a social security scheme or beneficiary of such a scheme
* Patient having signed the free and informed consent

Exclusion Criteria:

* Minor, age ≤ 40 years or ≥ 75 years
* ASA 4 or more
* Severe or poorly balanced associated conditions
* Covid + declared in the previous 3 months
* Refusal to participate in the study
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision

Primary outcomes:
measure: postoperative stay of RAAC-type treatment
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Clinique Saint Augustin
state: Nouvelle Aquitaine
Study officials:
References:
Clinical trial NCT02423486: The Comparison of Efficacy Between Electromagnetic Stimulation Therapy and Electromagnetic Stimulation Therapy With Extracorporeal Biofeedback
Official title: The Comparison of Efficacy Between Electromagnetic Stimulation Therapy and Electromagnetic Stimulation Therapy With Extracorporeal Biofeedback
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Stress Incontinence
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2015-04-22
Enrollment: 66
Sex: FEMALE
Minimum age (years): 20
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 compare the efficacy between Electromagnetic Stimulation therapy and Electromagnetic Stimulation therapy with Extracorporeal Biofeedback in Stress Urinary Incontinence patient.


Eligibility criteria: Inclusion Criteria:

1. Female patient with Stress Urinary Incontinence, over 20
2. Leakage over 2g in stress pad test
3. Capable of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risks and benefits

Exclusion Criteria:

1. Mixed Urinary Incontinence which is dominant in urge urinary incontinence.
2. True incontinence
3. Overflow incontinence
4. Patient who had performed electric stimulation therapy,bladder training within 2 weeks before baseline.
5. Urinary tract infection found In urine test.
6. Patient who had pelvic organ prolapse.
7. Patient who had inserted pacemaker.
8. Pregnant woman, patient who have positive result in urine pregnancy test, patient who have plan pregnancy during study period.
9. Disorder in Neurosystem like stroke, multiple sclerosis, spinal injury, Parkinson's disease .
10. Patient who will participate in other clinical trial during this study.
11. Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion

Primary outcomes:
measure: Rate comparison of complete recovery in stress pad test after 12 weeks of treatment
timeFrame: 12 weeks
Secondary outcomes:
measure: Incontinence Severity VAS at baseline,4weeks,8weeks,12weeks after treatment
timeFrame: 12 weeks
measure: Sandvik questionnaire at baseline,4weeks,8weeks,12weeks after treatment
timeFrame: 12 weeks
measure: Incontinence - Quality of Life questionnaire at baseline,8weeks,12 weeks after treatment
timeFrame: 12 weeks
measure: Benefit,Satisfaction and Willingness to Continue questionnaire at 12 weeks after treatment
timeFrame: 12 weeks
measure: Pelvic floor muscular strength at baseline,4weeks,8weeks,12weeks after treatment
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Kyu-Sung Lee, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00239486: Dose Finding Study of Pramipexole (Sifrol) in Patients With Idiopathic Restless Legs Syndrome (RLS)
Official title: Evaluation of the Effect of Different Doses of Pramipexole on Subjective and Objective Symptoms of Idiopathic Restless Legs Syndrome (RLS).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Restless Legs Syndrome
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2005-10-17
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the efficacy and safety of different doses of pramipexole (Sifrol) on subjective and objective symptoms of idiopathic Restless Legs Syndrome (RLS) and also to determine the optimal dose of pramipexole in patients with RLS by polysomnography and evaluation of clinical improvement.


Eligibility criteria: Inclusion Criteria:

1. Male and female 18-80 years
2. Confident diagnosis of RLS according to International RLS Study Group criteria
3. RLS rating scale for severity score \>15
4. PLM (during time in bed ) index at least 5 per hour
5. Weekly presence of RLS symptoms within last three months
6. Written Informed consent

Exclusion Criteria:

1. Women of childbearing potential, who do not use adequate protection such as barrier protection, intrauterine device, or hormonal (oral or subcutaneous) contraception
2. Postmenopausal women less than 6 months after last menses, surgically sterilised, oophorectomised or hysterectomised less than 3 months after operation and not using adequate protection
3. Women neither using adequate protection nor being postmenopausal and their partner is not sterilised at least 6 months post operation or does not use condom
4. Any women not having negative serum pregnancy test at screening

Primary outcomes:
measure: Reduction in periodic limb movements during time in bed index (PLMI) in the polysomnography (PSG).
timeFrame: 3 weeks
Secondary outcomes:
measure: Secondary outcomes of the study were other PSG-derived endpoints (changes in the RLS symptom rating scale (RLSRS), and patient reported outcomes).
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: NEURO
Study officials:
affiliation: B.I. Finland Ky
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References:
Clinical trial NCT00440986: Clinical Management of Hereditary Hemochromatosis: Phlebotomy vs. Erythrocytoapheresis
Official title: Clinical Management of Hereditary Hemochromatosis: Phlebotomy vs. Erythrocytoapheresis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hereditary Hemochromatosis
Keywords: Clinical Management
Phlebotomy
Eritrocytoapheresis
Lead sponsor: San Filippo Neri General Hospital
Sponsor class: OTHER
First posted: 2007-02-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of study is to determine the best and durable choice of treatment between phlebotomy and eritrocytoapheresis in the medium- and long-term clinical management of HH

Detailed description: Patients affected by Hereditary hemochromatosis need a completeinitial staging of disease, a correct clinical management, a good chance of treatment and long-term follow-up. Clinical manifestations at presentation and during follow-up may consistently vary according to diagnostic criteria, treatment options and follow-up durability, up to the interruption. So, 25 caucasian patients, 16 males and 6 females of age \>18 yrs. have been consecutively diagnosed and randomly included into two arms of treatment, phlebotomy vs. eritrocytoapheresis, evaluating, at baseline and 6-12-18-24-36 months, the clinical status concerning liver, kidney, pancreas, heart, endocrine iron overload and function and final outcome related to therapeutic strategy, including the cost/effectiveness analysis

Eligibility criteria: Inclusion Criteria:

* Patiens newly diagnosed having Hereditary Hemochromatosis

Exclusion Criteria:

* Age \< 18 yrs.
* Not obese (BMI \<30)
* Not consuming alchol beverages,
* Not affected by systemic diseases and known hepatic viruses

Primary outcomes:
measure: To prospectively determine the best choice of tretment in HH
measure: To evaluate the global outcome according to treatment choice
Secondary outcomes:
measure: To evaluate the outcome of specific clinical features according to treatment choice
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Department of Transfusion Medicine-San Filippo Neri General Hospital
Study officials:
affiliation: San Filippo Neri General Hospital
name: Francesco Equitani, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pietrangelo A. Hereditary hemochromatosis--a new look at an old disease. N Engl J Med. 2004 Jun 3;350(23):2383-97. doi: 10.1056/NEJMra031573. No abstract available.
citation: Equitani F, Fernandez-Real JM, Menichella G, Koch M, Calvani M, Nobili V, Mingrone G, Manco M. Bloodletting ameliorates insulin sensitivity and secretion in parallel to reducing liver iron in carriers of HFE gene mutations. Diabetes Care. 2008 Jan;31(1):3-8. doi: 10.2337/dc07-0939. Epub 2007 Oct 24.
Clinical trial NCT00203086: A Study to Evaluate the Long Term Safety and Effectiveness of Novantrone Therapy Followed by Copaxone Treatment for Multiple Sclerosis
Official title: A Multi-Centered, Two Arm, Open Label Extension Study (to Protocol NC-100) to Evaluate the Long-Term Safety and Efficacy of Short-Term Induction Treatment With Mitoxantrone (Novantrone®) Preceding Treatment With Glatiramer Acetate (Copaxone®) vs. Chronic Treatment With Glatiramer Acetate Alone in Relapsing Forms of Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsing Remitting Multiple Sclerosis
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 57
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neurology Clinics

Brief summary: It is thought that treating Multiple Sclerosis with Novantrone for a short period of time prior to treatment with Copaxone may enhance the onset effect of Copaxone.


Eligibility criteria: Inclusion Criteria:

* Participation \& completion of the NC-100 Clinical Trial.
* Able and willing to sign an Informed Consent.

Exclusion Criteria:

none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Teva Neuroscience, Inc.
name: Lillian Pardo, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02028286: A 21 Day Pharmacokinetics Study in Papulopustular Rosacea
Official title: A Phase 1, Open Label, Multiple Center Study to Evaluate the Pharmacokinetics of Once-Daily CLS001 Topical Gel Under Maximal Use Conditions Administered for 21 Days in Subjects With Papulopustular Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Papulopustular Rosacea
Keywords: Rosacea
Lead sponsor: Maruho Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-01-07
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to characterize the pharmacokinetics of once daily topical gel and confirm that steady state conditions are reached under maximal use conditions following 3 weeks of daily applications.


Eligibility criteria: Inclusion Criteria:

* A diagnosis of papulopustular rosacea
* Grade 3 or 4 on the 5-point Investigator Global Assessment scale
* Presence of telangiectasia

Exclusion Criteria:

* steroid rosacea or subtype 3 (phymatous rosacea)
* clinically significant abnormal findings that would interfere with study objective or risk to safety for the subject.
* nodular rosacea (lesions greater than 5mm with more than 2 modules)

Primary outcomes:
measure: Plasma concentrations of CLS001 to determine pharmacokinetic parameters at visit 2, visit 3 and visit 5
timeFrame: 24 days
Secondary outcomes:
measure: incidence of adverse events
timeFrame: 24 days
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Frontage Clinical Services
state: New Jersey
city: Austin
country: United States
facility: Derm Research
state: Texas
Study officials:
References:
Clinical trial NCT06320886: Role of Ultrasonography in Acute Abdomen in Adults in Correlation to Computed Tomography Scan
Official title: Role of Ultrasonography in Acute Abdomen in Adults in Correlation to Computed Tomography Scan
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Abdomen
In Adults
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults presented to the ER of Sohag University Hospital with Acute abdominal pain, both Ultrasonography and Computed tomography are used to diagnose the causes.

Brief summary: The study aims to evaluate the role of Ultrasonography in the diagnosis of the cause of acute abdominal pain in 50 adults presenting in the ER at Sohag University Hospital and compares it to the Computed Tomography scan results of the same patients to discover the superiority of both over the other in the diagnosis of different acute abdomen cases.


Eligibility criteria: Inclusion Criteria:

* Adults presented with Acute abdominal pain.

Exclusion Criteria:

* less than 18 years old patients
* Pregnant women

Primary outcomes:
measure: Comparison between the role of Ultrasonography and Computed Tomography in Acute Abdomen diagnosis
timeFrame: 6-9 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References: