louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00633646: Effect of Protein-Restricted Diet on Nitrogen Balance and Residual Renal Function in Peritoneal Dialysis (PD) Patients
Official title: Effect of Protein-Restricted Diet on Nitrogen Balance and Residual Renal Function in PD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Peritoneal Dialysis
Keywords: nitrogen balance
malnutrition
chronic kidney disease
diet
glomerular filtration rate
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2008-03-12
Enrollment: 94
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: Current therapy recommendations suggest a low protein diet to preserve residual renal function (RRF) before the start of dialysis, but a higher protein intake during dialysis to prevent protein-energy wasting (PEW). We conducted a randomized trial to test whether low protein intake also during treatment with peritoneal dialysis (PD) would be safe and associated with a preserved RRF.

Detailed description: Dietary protein is the major source of nitrogen excreted as urea by the kidney, and a decreased protein intake has been associated with a retardation of kidney function loss in non-dialysis chronic kidney disease (CKD) patients. While a low protein diet is recommended to end-stage renal disease (ESRD) patients before the start of dialysis to preserve residual renal function(RRF), current therapy recommendations in dialysis are for a normal protein intake of no less than 1.2 g of protein/kg ideal body weight (IBW)/day to prevent protein-energy wasting (PEW).

We hypothesized that a lower protein intake would be safe and able to slow the loss of RRF also in dialysis patients and conducted two prospective, randomized trials involving a total of 94 peritoneal dialysis (PD) patients to test our hypothesis.

Eligibility criteria: Inclusion Criteria:

* age 18-80 years
* stable peritoneal dialysis since at least 1 month
* with renal function

Exclusion Criteria:

* a high probability (assessed by the recruiting physician) of receiving a kidney transplant within one year
* overt infection within the last month
* poor compliance in previous dietary prescriptions or irregular check-ups
* persistent anorexia, vomiting or diarrhea within the last month
* a CRP of more than 30 mg/dL
* presence of wasting diseases such as cancer or tuberculosis

Primary outcomes:
measure: nitrogen balance,residual renal function and nutritional status
timeFrame: 10 day and 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: RenJi Hospital
name: Yao Qiang, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03407846: Total Laparoscopic Hystrectomy Versus Total Abdominal Hystrectomy
Official title: Total Laparoscopic Hystrectomy Versus Total Abdominal Hystrectomy: the Effect of Learning Curve a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Effect of Learning Curve on Operative Time in TLH and Comparing it to TAH
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 100
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 100 patient will be recruited for hystrectomy for benign cause and TLH will be copared to TAH and effect of learning curve will be assessed by comparing operative time between early and lat patients in TLH group


Eligibility criteria: Inclusion Criteria:

- Age. More than 40 Uterine size less than 14 weeks No contraindications for laparscopic surgery Benign cause for hystrectomy

Exclusion Criteria:

* virgins Malignancy

Primary outcomes:
measure: Operative time
timeFrame: 2 years
Secondary outcomes:
measure: Blood loss, coplications, postoperative pain
timeFrame: 2 years
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university
Study officials:
References:
Clinical trial NCT02967146: Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®) After Axillary Dissection for Breast Cancer
Official title: Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®) After Axillary Dissection for Breast Cancer A Multicenter Double-blinded, Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breastcancer
Surgery: Axillary Dissection
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2016-11-18
Enrollment: 170
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Anti-adhesive effect and Safety of a mixed solid of poloxamer, gelatin and chitosan(Mediclore®) after axillary dissection for breast cancer

Detailed description: A Multicenter Double-blinded, Randomized Study

Eligibility criteria: Inclusion Criteria:

* the patients needed axillary dissection in breast cancer
* Written informed consent
* Patients without clinically significant lab
* the patients who are diagnosed 'positive for metastasis' by sentinel lymph node biopsy

Exclusion Criteria:

* having enrolled another clinical trials within 1 month
* Immunosuppression or autoimmune disease
* Anticoagulant, general steroids within a week from surgery
* Incompatible medications
* Serious diseases (heart failure, renal failure, liver failure, uncontrolled hypertension, diabetes mellitus, coagulation deficiencies)

Primary outcomes:
measure: sum of ROM(range of motion)
timeFrame: 4weeks
Secondary outcomes:
measure: sum of ROM(range of motion)
timeFrame: 24weeks
measure: pain assessment (numeric pain rating scale)
timeFrame: 4weeks, 24weeks
measure: Scoring DASH(Disablities of the arm, shoulder and hand)
timeFrame: 4weeks, 24weeks
Other outcomes:
Locations:
city: Seoul City
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
citation: Choi HJ, Ryu JM, Chae BJ, Kim EK, Min JW, Shin HJ, Nam SJ, Yu J, Lee JE, Lee SK, Kim SW. Effect of Poloxamer-Based Thermo-Sensitive Sol-Gel Agent on Upper Limb Dysfunction after Axillary Lymph Node Dissection: A Double-Blind Randomized Clinical Trial. J Breast Cancer. 2021 Aug;24(4):367-376. doi: 10.4048/jbc.2021.24.e30. Epub 2021 Jun 17.
Clinical trial NCT01257646: Observation of the Gait Cycle in Patients With Hemiplegia in Order to Improve the Triggering of Functional Electrical Stimulation
Official title: Observation of the Gait Cycle in Patients With Hemiplegia in Order to Improve the Triggering of Functional Electrical Stimulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2010-12-10
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study patients are recuted from the patient pool that is either hospitalized or consulting in the department of Neurological Reeducation and Readaptation at the Grau du Roi medical center at the Nîmes University Hospital (Centre Hospitalier Universitaire de Nîmes). Patients are stroke victims with gait problems.

Brief summary: The main objective of this study is the estimation and comparison of the dephasing between the switch heel and the inertial placed on the paretic foot compared to the events of the gait cycle determined by a Gaitrite system (beginning and end of the swing phase) in conditions without stimulation.


Eligibility criteria: Inclusion Criteria:

* patient has had a first ischemic or hemorragic stroke (supratentorial) within the last 6 months for the "recent stroke" group, or more than a year ago for the "old stroke" group
* the patient can walk 10 m without human help, with or without a cane, and a deficit of the foot levator requiring the use of technical assistance to remedy this or involving walking problems
* electrostimulated contraction of the anterior tibialis is possible
* patient has been informed and has signed the consent form

Exclusion Criteria:

* cognitive disorder making participation in the study difficult
* fixed plantar flexion, knee extended below 0°
* patient refuses to sign consent
* patient is not covered by a social security system
* patient is under any kind of guardianship

Primary outcomes:
measure: Timing of heel strike (s)
timeFrame: 10 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Centre Hospitalier Universitaire de Nîmes
state: Gard
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Jérôme Froger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01513746: Eating Disorders in Type 1 Diabetes: Mechanisms of Comorbidity
Official title: Eating Disorders in Type 1 Diabetes: Mechanisms of Comorbidity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Eating Disorder
Keywords: Type 1 Diabetes
Type 1 Diabetes Mellitus
Eating Disorders
Insulin Omission
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2012-01-20
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: UNC and Duke Endocrine Clinics Community of the Durham, Chapel Hill and Raleigh area

Brief summary: The purpose of the study is to investigate how people with type 1 diabetes experience and manage their diabetes, eating, and weight. Summary of the Study: If you choose to participate, you will complete a set of questionnaires and a structured interview. You will then wear a continuous glucose monitor and use your cell phone to answer study questions for a period of 3 days. The questions come in the form of regular phone calls between the hours of 8:00 a.m. and 10:00 p.m. Each call takes only a minute or two to complete. You will also be asked to call in and answer study questions at other times during the day, especially after eating. The study involves a minimum of 2 clinic visits to Duke. Participants who live greater than 1.5 hours from Duke can be approved to take part in the study by phone/Skype. Participants will receive and return study materials through the mail.

Detailed description: Eating disorders (ED) are far more prevalent among individuals with type 1 diabetes (T1D) than the general population. Yet what accounts for the increased prevalence of ED in T1D, and how to effectively treat these patients is unknown. ED in T1D is dangerous. T1D patients with ED not only engage in behaviors common among non-diabetic ED patients (like binge eating), but also might omit insulin to prevent weight gain. The goal of this study is to understand the psychophysiological precipitants to ED behavior among T1D patients.

Eligibility criteria: Inclusion Criteria:

1. Adult (aged 18-65)
2. Diagnosed with type 1 diabetes
3. Clinically significant eating disorder symptoms
4. Currently monitored by a physician

Exclusion:

1. Severe hypoglycemic unawareness
2. Pregnancy
3. Current or history of psychosis or mania
4. Current substance abuse
5. Non-English speaking
6. Significant deficits in intellectual functioning

Primary outcomes:
measure: Blood Glucose Values
timeFrame: 72 Hours
Secondary outcomes:
measure: Ecological Momentary Assessment of Emotional and Behavioral Outcomes
timeFrame: 72 hours
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
affiliation: Site Principal Investigator
name: Rhonda Merwin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01589146: ONE WEEK VERSUS FOUR WEEK HEPARIN PROPHYLAXIS AFTER LAPAROSCOPIC SURGERY FOR COLORECTAL CANCER.
Official title: ONE WEEK VERSUS FOUR WEEK HEPARIN PROPHYLAXIS IN PATIENTS WITH COLORECTAL CANCER UNDERGOING LAPAROSCOPIC SURGERY: INCIDENCE OF VENOUS THROMBOEMBOLISM AND BLEEDING COMPLICATIONS. THE PRO-LAPS STUDY.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: The Primary Study Objective is to Assess the Efficacy and
Safety of Extended 4-week Heparin Prophylaxis Compared to
Prophylaxis Given for 8±2 Days After Planned Laparoscopic
Surgery for Colorectal Cancer.
The Clinical Benefit Will be Evaluated as the Difference in
the Incidence of VTE or VTE-related Death Occurring Within 30 Days
From Surgery in the Two Study Groups.
Keywords: colon-rectal cancer
heparin
prophylaxis
laparoscopy
Lead sponsor: University Of Perugia
Sponsor class: OTHER
First posted: 2012-05-01
Enrollment: 400
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: Overall, only limited evidence exists regarding the clinical benefit of antithrombotic prophylaxis after laparoscopic surgery for cancer. Four studies reported on the incidence of venous thromboembolism (VTE) after laparoscopic surgery for cancer. These studies differ concerning study design, site of cancer, regimens for antithrombotic prophylaxis and reported incidence of VTE.

The aim of this multicenter, randomized study is to assess the clinical benefit of extended (4 weeks) compared to short (one week) heparin prophylaxis after laparoscopic surgery for colorectal cancer.


Eligibility criteria: Inclusion Criteria:

* Consecutive patients who had
* planned laparoscopic surgery for
* colorectal cancer will be included in the study provided no exclusion criteria will be found

Exclusion Criteria:

* age \< 18 years
* surgery for non-cancer disease
* duration of surgery \< 45 min
* other indication for anticoagulant therapy
* known cerebral metastases
* kidney or liver failure
* known hemorrhagic diathesis or high risk for bleeding
* history of intracerebral bleeding or neurosurgery within 6 months, history of heparin induced thrombocytopenia
* pregnancy or lactation
* refusal of informed consent.

Primary outcomes:
measure: symptomatic objectively confirmed VTE, asymptomatic ultrasonography-confirmed DVT or VTE-related death
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Perugia
country: Italy
facility: Internal and Cardiovascular Medicine - University of Perugia
Study officials:
References:
citation: Vedovati MC, Becattini C, Rondelli F, Boncompagni M, Camporese G, Balzarotti R, Mariani E, Flamini O, Pucciarelli S, Donini A, Agnelli G. A randomized study on 1-week versus 4-week prophylaxis for venous thromboembolism after laparoscopic surgery for colorectal cancer. Ann Surg. 2014 Apr;259(4):665-9. doi: 10.1097/SLA.0000000000000340.
Clinical trial NCT00716846: Effects of Statins on the Pharmacokinetics for Midazolam in Healthy Volunteers
Official title: Effects of Three Statins, Simvastatin, Atorvastatin, and Pitavastatin, on the Pharmacokinetics for Midazolam in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Hamamatsu University
Sponsor class: OTHER
First posted: 2008-07-16
Enrollment: 11
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether statins have any influence on cytochrome P450 (CYP) 3A4 enzyme activity using a probe drug midazolam.


Eligibility criteria: Inclusion Criteria:

* Volunteers in good health according to their medical history, a physical examination and standard laboratory tests

Exclusion Criteria:

* Subjects who have been using any continuous medication or herbal supplements.

Primary outcomes:
measure: the pharmacokinetics of oral midazolam
timeFrame: after 14-days treatment with statins
Secondary outcomes:
Other outcomes:
Locations:
city: Hamamatsu
country: Japan
facility: Hamamatsu University School of Medicine
Study officials:
affiliation: Hamamatsu University
name: Hiroshi Watanabe, MD,PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02629146: Analgesic Effects of Midazolam in Human Volunteers
Official title: A Single Center, Prospective, Randomized, Double Blind, Placebo-controlled, Three-way Cross-over Study of the Analgesic Effects of Midazolam Versus Placebo With Fentanyl as an Active Control in Human Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Analgesic Drugs
Antinociceptive Agents
Keywords: Midazolam
Fentanyl
Lead sponsor: Wilhelminenspital Vienna
Sponsor class: OTHER
Collaborators: name: Akron Molecules AG
First posted: 2015-12-14
Enrollment: 24
Sex: ALL
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: This study evaluates analgesic properties of midazolam compared to placebo and fentanyl. Each participant will receive all three drugs (midazolam, fentanyl, placebo) on three different occasions (study visits) and the effect on different pain stimuli will be tested.


Eligibility criteria: Inclusion Criteria:

* male and female volunteers
* 18-40 years old
* healthy
* body mass index between 5th and 85th percentile
* Caucasian
* non smoker or moderate smoker (\<10 cigarettes per day)
* able to understand, write, and read German

Exclusion Criteria:

* acute or chronic pain condition (except for mild day-to-day pain on \<5 days/month)
* previous (up to 5 days preceding the study) or current medications prescription or over-the-counter, especially analgesics
* symptoms of a clinically relevant illness in the 2 weeks before the first study day
* hypertension
* any known psychiatric condition
* abuse of alcoholic beverages, drug abuse
* known positive human immunodeficiency virus status
* any known medical condition which may interact with study medication, study objectives, or compliance of subject with study tasks
* participation in a clinical trial in the 4 weeks preceding the study
* known allergy against Midazolam
* known allergy against Fentanyl
* pregnancy or breast-feeding
* unable or unwilling to give informed consent
* unable or unwilling to follow investigator's instructions
* unable or unwilling to comply with study protocol

Primary outcomes:
measure: Change in pain ratings (0-100) to a suprathreshold heat pain stimulus
timeFrame: 3.5 Minutes after end of infusion
Secondary outcomes:
measure: Change in pain ratings to a suprathreshold electrical pain stimulus
timeFrame: 3.5 Minutes after end of infusion
measure: Increase of pressure pain thresholds (kPa)
timeFrame: Up until 23 Minutes after end of infusion
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Schmerzdiagnostik / Clinical Research Unit
Study officials:
affiliation: Wilhelminenspital Vienna
name: Burkhard Gustorff, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02205346: Urinary Leukotriene E4 Levels in Children With Obstructive Sleep Apnea
Official title: Urinary Leukotriene E4 Levels in Children With Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Keywords: obstructive sleep apnea
Lead sponsor: Eastern Virginia Medical School
Sponsor class: OTHER
Collaborators: name: Medarva
First posted: 2014-07-31
Enrollment: 130
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Otolaryngology practice

Brief summary: Investigate urinary leukotriene E4 levels and determine if there is a correlation with severity of obstructive sleep apnea. The investigators then would like to determine a threshold level which could then be used for confirmation of diagnosis of obstructive sleep apnea (OSA).


Eligibility criteria: Inclusion Criteria:

* children 2-16 years of age
* scheduled for polysomnogram

Exclusion Criteria:

* cardiovascular, neuromuscular, immunologic or craniofacial disorders
* pharmacologic treatment including corticosteroids and leukotriene receptor antagonists in the last month
* subjects who have already received treatment for OSA with an oral appliance, continuous positive airway pressure (CPAP) device
* previously undergone tonsillectomy and/or adenoidectomy

Primary outcomes:
measure: urine leukotriene level
timeFrame: baseline
Secondary outcomes:
measure: correlation between Urine LTE4 and the apnea hypopnea index (AHI)
timeFrame: baseline
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Children's Hospital of the King's Daughters
state: Virginia
Study officials:
affiliation: EVMS
name: Cristina Baldassari, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03257046: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ITI-214 in Parkinson's Disease
Official title: A Randomized, Placebo-Controlled, Double-Blind Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of ITI-214 in Patients With Idiopathic Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Parkinson Disease
Lead sponsor: Intra-Cellular Therapies, Inc.
Sponsor class: INDUSTRY
First posted: 2017-08-22
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multiple rising dose in sequential cohorts of 8 patients randomized in a 6:2 ratio to receive ITI-214 or placebo
Primary purpose: TREATMENT

Brief summary: This is a Phase I/II randomized, double-blind, placebo-controlled, multiple rising dose study in patients with stable idiopathic Parkinson's disease (PD) to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ITI-214.


Eligibility criteria: Major Inclusion Criteria:

* Clinical diagnosis of idiopathic Parkinson's disease (PD)
* Severity of PD assessed by Hoehn and Yahr Staging score of 1 to 3
* Maintenance on stable PD therapy

Major Exclusion Criteria:

* Clinical signs of dementia
* Suicidal ideation or behavior
* Considered medically inappropriate for study participation

Primary outcomes:
measure: Number of patients with reported or observed treatment-related adverse events
timeFrame: 7 days
Secondary outcomes:
measure: Maximum Plasma Concentration (Cmax)
timeFrame: 7 days
measure: Area of the Curve (AUC)
timeFrame: 7 days
measure: Motor and non-motor symptoms as assessed by the MDS-UPDRS
timeFrame: 7 days
Other outcomes:
measure: Exploratory biomarkers
timeFrame: 7 days
Locations:
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Durham
country: United States
facility: Duke Early Phase Research Unit
state: North Carolina
Study officials:
affiliation: Intra-Cellular Therapies, Inc.
name: Kimberly Vanover, PhD
role: STUDY_DIRECTOR
References: