louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01131897: Bioavailability Study of Levetiracetam Tablets, 750 mg of Dr. Reddy's Under Fasting Conditions.
Official title: Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Dr. Reddy's Levetiracetam Tablets, 750 mg and Keppra® 750 mg Tablets of UCB Pharma in Healthy Adult Male Volunteers Under Fasting Conditions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioavailability
Crossover
Levetiracetam
Lead sponsor: Dr. Reddy's Laboratories Limited
Sponsor class: INDUSTRY
First posted: 2010-05-27
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the single-dose relative bioavailability study of Levetiracetam Tablets 750 mg with Keppra® 750 mg Tablets under Fasting conditions.

Detailed description: This is an open-label, randomized, single-dose 2-way crossover relative bioavailability study in healthy adult male volunteers under fasting conditions with a washout period of 7 days.

Eligibility criteria: Inclusion Criteria:

* Healthy adult male volunteers, 18 to 55 years of age;
* Weighing at least 60 kg and within 15% of their ideal weights (Table of "Desirable Wights of Adults", Metropolitan Life Insurance Company, 1983);
* Medically healthy subjects with clinically normal laboratory profiles and ECGs as deemed by the principal investigator;
* Voluntarily consent to participate in the study

Exclusion Criteria:

* History or presence of significant cardiovascular, pulmonary, hepatic, renal hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
* In addition, history or presence of:

  1. alcoholism or drug abuse within the past 2 years;
  2. hypersensitivity or idiosyncratic reaction to levetiracetam;
* Subjects who have been on an special diet (for whatever reason) during the 30 days prior to the first dose and throughout the study.
* Subjects who have made a donation (Standard donation amount or more) of blood or blood products (with the exception of plasma as noted below) within 56 days prior to the first dose.
* Subjects who have made a plasma donation within 7 days prior to the first dose.
* Subjects who have participated in another clinical trial within 30 days prior to the first dose.
* Subjects with hemoglobin less than 12.0 g/dL.
* Subjects who have participated in another clinical trial within 30 days prior to the first dose.

Primary outcomes:
measure: Bioavailability based on Cmax and AUC parameters
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Neptune
country: United States
facility: MDS Pharma Services
state: New Jersey
Study officials:
affiliation: MDS Pharma Services
name: Magdy L Shenouda, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01917097: Bradycardia Following Intraoperative Administration of Dexmedetomidine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tonsillectomy
Adenotonsillectomy
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2013-08-06
Enrollment: 921
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients having ENT surgery at Nationwide Children's Hospital.

Brief summary: This is a retrospective chart review to evaluate the postoperative course of all pediatric patients admitted to the hospital following adenotonsillectomy over the past 24 months to evaluate the incidence of bradycardia in children who received dexmedetomidine intraoperatively and identify confounding factors which may be precipitating the bradycardia or potentiating the negative chronotropic effects of dexmedetomidine.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing adenontonsillectomy or tonsillectomy during 2011 and 2012.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Bradycardia
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Joseph D Tobias, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00635297: Percutaneous Vertebroplasty: Prophylactic Treatment of Adjacent Vertebra
Official title: Percutaneous Vertebroplasty.Study of Refracture Rates After Prophylactic Vertebroplasty of Adjacent Vertebrae
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Osteoporosis
Vertebral Fracture
Keywords: osteoporosis
vertebroplasty
prophylactic
vertebrae
fracture
Lead sponsor: Ullevaal University Hospital
Sponsor class: OTHER
First posted: 2008-03-13
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Percutaneous vertebroplasty is a treatment for painful osteoporotic compression fractures. Multiple reports have shown as high as 20 % refracturerates in vertebrae adjacent to those that have been treated with percutaneous vertebroplasty.

The purpose of the study is to determine if prophylactic vertebroplasty of unfractured vertebrae adjacent to the treated fractured vertebrae can reduce the rates of refracture in adjacent vertebrae.


Eligibility criteria: Inclusion Criteria:

* CT and MRI proven non healed painful osteoporotic compression fracture in the thoracic and lumbar spine.

Exclusion Criteria:

* Infection
* High grade spinal stenosis
* Contraindications to MRI
* Dementia

Primary outcomes:
measure: Refracture rate based on MRI and CT after 3 months and one year
timeFrame: 3 months and one year
Secondary outcomes:
measure: Pain relief after the procedure based on VAS
timeFrame: 3 months and one year
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Nevroradiologisk avdeling Ullevål universitetssykehus HF
Study officials:
affiliation: Nevroradiologisk avdeling Ullevål Universitetssykehus HF
name: Per Hj Nakstad, Phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT04146597: Short-term Effects of Active Post-training Slider Neural Mobilization
Official title: Short-term Effects of Active Post-training Slider Neural Mobilization on Hamstring Flexibility in Jiu Jitsu Practitioners: a Quasi-experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adults
Lead sponsor: University of Brasilia
Sponsor class: OTHER
First posted: 2019-10-31
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Jiu Jitsu is a martial art that consists of various techniques that aim to place the opponent in submission. It is essentially a ground fight that requires large movement variety, among which flexibility is a substantial physical aptitude, required to perform specific positions of attack or defence, especially flexibility of the thoracolumbar spine and hamstrings. The literature reports that abnormal posterior lower limb neurodynamics may influence hamstring extensibility and muscle length, and lead to changes in perception of stretch and pain. The objective of the present study is to evaluate the effect of NM, using sliding techniques of the sciatic nerve, immediately after Jiu Jitsu training, on HM flexibility of Jiu Jitsu practitioners. The hypothesis is that NM sliders applied immediately after training would be as effective as an isolated intervention, as demonstrated in soccer players.


Eligibility criteria: Inclusion Criteria:

* Healthy adults of regular practitioners of Jiu Jitsu;
* Aged between 18 and 59 years;
* Both sexes.

Exclusion Criteria:

* Straight Leg Raise (SLR) test \> 75º;
* Hamstrings injury in the previous three months;
* History of any neurological disorder (such as sensory deficits and irradiated pain) or orthopaedics (such as soft tissue or bone injuries) that affected a lower extremity;
* Positive neural tension test (uni or bilateral);
* Fracture in a lower extremity with surgical treatment history in the previous12 months and with conservative treatment in the previous 6 months;
* Herniated lumbar disc diagnosis.

Primary outcomes:
measure: Passive Knee Extension Test (PKE)
timeFrame: 5 week follow up.
measure: Straight leg raise test (SLR):
timeFrame: 5 week follow up.
Secondary outcomes:
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: University of Brasilia
state: Distrito Federal
Study officials:
affiliation: University of Brasilia
name: Wagner Martins
role: PRINCIPAL_INVESTIGATOR
References:
citation: Castellote-Caballero Y, Valenza MC, Martin-Martin L, Cabrera-Martos I, Puentedura EJ, Fernandez-de-Las-Penas C. Effects of a neurodynamic sliding technique on hamstring flexibility in healthy male soccer players. A pilot study. Phys Ther Sport. 2013 Aug;14(3):156-62. doi: 10.1016/j.ptsp.2012.07.004. Epub 2012 Nov 8.
citation: Andreato LV, Lara FJD, Andrade A, Branco BHM. Physical and Physiological Profiles of Brazilian Jiu-Jitsu Athletes: a Systematic Review. Sports Med Open. 2017 Dec;3(1):9. doi: 10.1186/s40798-016-0069-5. Epub 2017 Feb 13.
Clinical trial NCT00134797: Glomerular Filtration Rate (GFR) Reporting on Nephrology Referral Patterns by Internists
Official title: The Effect of MDRD GFR Reporting on Nephrology Referral Patterns by Internists
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Kidney Disease
Keywords: GFR
serum creatinine
Lead sponsor: United States Naval Medical Center, San Diego
Sponsor class: FED
First posted: 2005-08-25
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: The addition of an estimate value of glomerular filtration rate (GFR) per Modification of Diet in Renal Disease \[MDRD\] (LEVEY) equation is being included and reported on all routine chemistry panels in the experimental group. The control group is only having serum creatinine, the current standard of care, reported on routine chemistry panels.

Detailed description: All patients already referred to or being followed by nephrologists were excluded. Inclusion criteria were all patients in the Internal Medicine clinic at NMCSD who were sent to the lab to obtain routine chemistry panels for follow up by their primary care providers. The primary outcome is increased referral to nephrology in accordance with NKF K/DOQI guidelines if GFR values are reported on routine chemistry panels. Key secondary outcomes are Primary Care Provider knowledge of NKF K/DOQI guidelines, specifically when patients with chronic kidney disease need to be referred to a nephrologist for further evaluation.

Eligibility criteria: Inclusion Criteria:

* All patients in the Internal Medicine Clinic at Naval Medical Center, San Diego (NMCSD) who were sent to the lab to obtain follow up by their primary care providers.

Exclusion Criteria:

* All patients referred to or being followed by nephrologists.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
Study officials:
affiliation: United States Naval Medical Center, San Diego
name: Heather J Miller, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02058797: Efficacy of Coherence Therapy for Procrastination
Official title: Efficacy of Coherence Therapy for Procrastination: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Procrastination
Keywords: Procrastination
Coherence Therapy
Cognitive Behavioral Therapy
Repertory Grid Technique
Cognitive Conflicts
Personal Dilemmas
Lead sponsor: University of Barcelona
Sponsor class: OTHER
First posted: 2014-02-10
Enrollment: 31
Sex: ALL
Minimum age (years): 19
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy of Coherence Therapy in treating procrastination. For that, this intervention is compared to Cognitive-Behavioral Therapy which was already proved to be efficacious in treating this problem. The method used is a randomized controlled trial.

Detailed description: Procrastination is a recognized difficulty that entails negative outcomes regarding performance and subjective well-being. In order to find effective treatments for procrastination, the present study wants to test the efficacy of Coherence Therapy, compared with Cognitive Behavioral Therapy. Procrastination, negative emotional states and cognitive structure will be assessed in pre-treatment and post-treatment evaluation. A total of 30 students will be randomly assigned to Coherence Therapy (n=15) or Cognitive Behavioral Therapy (n=15). In both forms of treatment students will receive three weekly sessions and one more session six to seven weeks after the third session. The treatment will be provided by trained psychotherapists. Findings would clarify the effectiveness of Coherence Therapy for the treatment of procrastination and the change of emotional states and cognitive structure of the students after the treatment.

Eligibility criteria: Inclusion Criteria:

* Being a student
* 19-26 years old
* A score above 51 on the General Procrastination Scale

Exclusion Criteria:

* Being currently under a psychological treatment
* Being diagnosed lately with any mental disorder
* Mental retardation
* Substantial visual, hearing or cognitive deficits
* Psychotic symptoms
* Organic brain dysfunction

Primary outcomes:
measure: General Procrastination Scale (Lay, 1986)
timeFrame: Post-treatment assessment (10-12 weeks)
Secondary outcomes:
Other outcomes:
measure: Repertory Grid Technique (Kelly, 1995; adaptation of Feixas & Cornejo, 1996)
timeFrame: Post-treatment assessment (10-12 weeks)
measure: Depression, Anxiety and Stress Scale (Lovibond & Lovibond, 1995)
timeFrame: Post-treatment assessment (10-12 weeks)
Locations:
city: Barcelona
country: Spain
facility: University of Barcelona
state: Catalonia
Study officials:
affiliation: University of Barcelona
name: Guillem Feixas, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03490097: Statins in Chronic Hepatitis C Patients Receiving Sofosbuvir/Daclatasvir Combination
Official title: Benefits of Statins in Chronic Hepatitis C Patients Receiving Sofosbuvir/Daclatasvir Combination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Hepatitis c
Metabolic Syndrome
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-04-06
Enrollment: 100
Sex: MALE
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: The purpose of the study is to determine if statin can affect the clinical outcome of chronic hepatitis C patients receiving Sofosbuvir/Daclatasvir/Ribavirin combination

Detailed description: Aim of the work

To determine the benefits of statin use in CHC patients treated with Sofosbuvir/Daclatasvir/Ribavirin through :

Primary Outcome: Assessment of therapeutic SVR12

Seconadry Outcome

1. assessment of Chronic hepatitis C(CHC) infection risk on development of metabolic syndrome through assessment of lipid profile , fasting glucose test , HgbA1C and C-reactive protein(CRP).

2- Evaluation of CHC related complications such as fibrosis and cirrhosis

Patients will be followed up for the whole study period and will be subjected to assessment of the following:

1. CBC , liver function test , lipid profile and CK every month till the end of therapy.
2. HgA1C and CRP at the end of therapy.
3. HCV-PCR test 3 months after the end of therapy.
4. Fibrosis using (FIB-4) 3 months after the end of therapy.

Eligibility criteria: Inclusion Criteria:

1. Male patients age 18 to 70 years old.
2. Easy to treat group: treatment naïve patients with serum HCV RNA positivity by PCR.
3. Clinically stable condition outpatients.
4. Platelet count ≥ 150,000/mm³.
5. INR ≤ 1.2.
6. Serum albumin ≥ 3.5 g/dl.
7. Total serum bilirubin ≤ 1.2 mg/dl.

Exclusion Criteria:

1. Inadequately controlled diabetes mellitus (HbA1c \> 9%) .
2. Total serum bilirubin \> 3mg/dl.
3. HCV-HIV co infection.
4. HBV-HCV co infection.
5. Any cause for chronic liver disease other than hepatitis C
6. Uncontrolled hypothyroidism.
7. Hepatocellular carcinoma, except 4 weeks after intervention aiming at cure with no evidence of activity by dynamic imaging (CT or MRI).
8. Extra-hepatic malignancy except after two years of disease-free interval.
9. Child's C cirrhotic patients.
10. Creatinine kinase \> 350 u/l

Primary outcomes:
measure: SVR 12
timeFrame: 3 months after end of therapy
Secondary outcomes:
measure: Lipid marker
timeFrame: three months
measure: Glycemic status marker
timeFrame: three months
measure: inflammatory marker
timeFrame: three months
Other outcomes:
measure: CHC related complications
timeFrame: 6 months
Locations:
city: Cairo
country: Egypt
facility: Kobri El koba Armed Forces Hospital
Study officials:
affiliation: Professor of clinical pharmacy , ASU
name: Nagwa Ali Sabri, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02528097: A Comparison of Two Albumin Administration Schedules for Spontaneous Bacterial Peritonitis
Official title: A Randomized Comparison of Two Albumin Administration Schedules for Spontaneous Bacterial Peritonitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Spontaneous Bacterial Peritonitis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2015-08-19
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Spontaneous bacterial peritonitis (SBP) is a common and frequently fatal complication of end-stage liver disease with a mortality of up to 10% primarily due to the development of kidney failure. Current standard practice is to treat this infection with broad spectrum antibiotics and salt-poor albumin administration on day one and three of treatment. In this study the investigators test the hypothesis that the administration of a second dose of albumin at 48 hours only to patients with renal insufficiency is as effective at preventing kidney failure as administering the second dose to all patients at 72 hours. In addition, a kidney function determined approach to albumin dosing may lead to substantial cost and resource saving from decreased albumin use without compromising treatment efficacy.


Eligibility criteria: Inclusion Criteria:

* Age 18 to 75
* Evidence of end stage liver disease / cirrhosis
* Documented SBP (ANC \> 250 or positive ascites culture
* Ability to provide informed consent
* Serum Creatinine \> 1.0 mg/dL and/or Total Bilirubin \> 4.0 mg/dL

Exclusion Criteria:

* Nonportal hypertensive ascites (i.e. malignancy)

Primary outcomes:
measure: Renal Failure
timeFrame: At any point from time 0 through day 3
Secondary outcomes:
measure: All Cause Mortality
timeFrame: At any point from time 0 through day 3
Other outcomes:
measure: Administration of Albumin
timeFrame: Throughout Study (72 hours)
Locations:
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
Study officials:
affiliation: NYU MEDICAL CENTER
name: Samuel Sigal
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04506697: Remote Monitoring of Uroflowmetry
Official title: Study of Remote Monitoring of Urination Dynamics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lower Urinary Tract Symptoms
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
Collaborators: name: Institute for Digital Medicine (WisDM)
First posted: 2020-08-10
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to assess the possibility of using remote monitoring of urination.


Eligibility criteria: Inclusion Criteria:

1. Men over 18 years old.
2. The patient has performed uroflowmetry according to indications in the hospital no later than 7 days before the planned inclusion in the trial.
3. Qmax = or \<15 ml / sec.
4. The patient has a smartphone (with Android 4.0 and higher, iOS 10.0 and higher) with Internet access

Exclusion Criteria:

1. A patient with emergency conditions requiring surgical treatment
2. Intellectual and cognitive abilities of the patient that do not allow him to follow the doctor's instructions and make it difficult to use the smartphone.

Primary outcomes:
measure: Uroflowmetry during 24 hours
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Institute for Urology and Reproductive Health, Sechenov University.
Study officials:
References:
Clinical trial NCT04034797: AmbulaNCE Teletransmited PHOtography for Trauma REgulation
Official title: AmbulaNCE Teletransmited PHOtography for Trauma REgulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trauma
Telemedicine
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2019-07-26
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Physicians in charge of medical regulation within French SAMU have to take difficult decisions regarding patient's orientation (in or out-of hospital care) but suffer from lack of information. Such information usually consist in a simple phone conversation without any visual information. Visual assesment of the situation would be of great help, especially for traumatized patients.

Private Ambulance societies all over territory in charge of SAMU 86 now work with teletransmission devices allowing photography transmission.

The objective of the study is to determine if routine use of teletransmitted photography help SAMU 86's physians for a better orientation of non-severe traumatized patients, especially by avoiding unnecessary transportations to Emergency Departments.


Eligibility criteria: Inclusion Criteria:

* Emergency call at SAMU for trauma issue
* Pre-hospital management by private ambulance equipped with teletransmission device

Exclusion Criteria:

* Severe trauma with need of a pre-hospital emergency medical team
* Traffic accident
* Head trauma associated with anticoagulant therapy or platelet antiagregant therapy
* Pre-hospital management by firefighters

Primary outcomes:
measure: Impact of Photography on patient orientation
timeFrame: 1 - 2 hours
Secondary outcomes:
measure: Undertriage
timeFrame: 10 days
measure: Overtriage
timeFrame: 10 days
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU Poitiers
state: Aquitaine
Study officials:
References:
citation: Magimel-Pelonnier E, Marjanovic N, Couvreur R, Drugeon B, Mimoz O, Guenezan J. Photography tele-transmission by regular ambulance staff for the management of mild traumatic injury: the NiCEPHORE randomised-controlled trial. Scand J Trauma Resusc Emerg Med. 2022 Oct 14;30(1):53. doi: 10.1186/s13049-022-01026-0.