louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05095883: Correlation Between Body Weight and Foot Progression Angle in Adolescents
Official title: Correlation Between Body Weight and Foot Progression Angle in Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity, Adolescent
Adolescent Development
Lead sponsor: Delta University for Science and Technology
Sponsor class: OTHER
First posted: 2021-10-27
Enrollment: 200
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Two hundred healthy non-athletic children from both sexes will participate in this study.

Brief summary: Obesity is associated with functional decline , altered spatiotemporal gait parameters (e.g. lower gait speed, shorter strides, and increased step width), and a significantly higher metabolic cost of walking compared to people with normal body weight. Obesity also negatively affects balance control.This study will investigate foot progression angle in adolescents related to their weight and category classification based on the CDC (Centers for Disease Control and Prevention) growth charts.


Eligibility criteria: Inclusion Criteria:

* All children have normal stature for age percentile according to CDC chart.
* The sample will include both sex and will be divided in to 4 groups according to the CDC (Centers for Disease Control and Prevention) growth charts.
* All children are normal \&perform all activities of daily living
* They were able to understand and follow verbal commands and instructions included in the testing procedures.

Exclusion criteria:

* All of them could be part of recreational activities in their public schools but no competitive sports. Children who participated in any regular sport activities involving the lower extremities will be excluded.
* None of them had any surgical intervention in the lower extremities.
* None of them had any history of musculoskeletal deformities or neuromuscular disorders.
* They had neither visual, auditory defect.

Primary outcomes:
measure: foot progression angle for healthy group
timeFrame: assessed immediately after the procedure
measure: foot progression angle for overweight group
timeFrame: assessed immediately after the procedure
measure: foot progression angle for obese group
timeFrame: assessed immediately after the procedure
measure: foot progression angle for underweight group
timeFrame: assessed immediately after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AAA
Study officials:
References:
Clinical trial NCT00380783: Safety and Efficacy of AGN 203818 for Pain Associated With Painful Bladder Syndrome/Interstitial Cystitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cystitis, Interstitial
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2006-09-26
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will explore the safety and effectiveness of different doses of AGN 203818 in treating the pain associated with painful bladder syndrome/interstitial cystitis


Eligibility criteria: Inclusion Criteria:

* Diagnosis of painful bladder syndrome/interstitial cystitis
* Moderate or severe bladder pain

Exclusion Criteria:

* Any other uncontrolled disease
* Pregnant or nursing females

Primary outcomes:
measure: Reduction in daily pain scores
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
state: Oklahoma
Study officials:
References:
Clinical trial NCT03535883: The Safety of Thoracentesis, Tunneled Pleural Catheter, and Chest Tubes in Patients Taking Novel Oral Anti-Coagulants
Official title: The Safety of Thoracentesis, Tunneled Pleural Catheter (Pleurx), and Chest Tubes in Patients Taking Novel Oral Anti-Coagulants (NOAC).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pleural Effusion
Thoracic Effusion
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2018-05-24
Enrollment: 590
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with unilateral or bilateral pleural effusions who undergo thoracentesis, chest tube, or pleurx placement.

Brief summary: To assess risks of bleeding in those individuals receiving Novel Oral Anti-Coagulant (NOAC) medications, admitted to the hospital and require thoracentesis, chest tube or tunneled pleural catheter placement.

Detailed description: The research component of this study simply observes and documents the outcomes of these procedures. Patients will undergo an analysis of their pre-procedural hematocrit and this will be compared to their post-procedural (next day) hematocrit.

Eligibility criteria: Inclusion Criteria:

1. Age \> 18 y/o
2. Unilateral or bilateral pleural effusion
3. Ability to provide consent or consent given for the procedure and research study

Exclusion Criteria:

Adults who refuse to provide consent.

Primary outcomes:
measure: Risk of bleeding
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Kyle Bramley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01866683: Yoga Effects on Heart Rate Variability and Electroencephalography
Official title: Effects of Yoga on Heart Rate Variability, Electroencephalography, Quality of Life and Salivary Cortisol of Healthy Adult Subjets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Quality of Life
Keywords: Yoga
Electroencephalography
Heart rate variability
Breathing Exercises
Quality of life
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2013-05-31
Enrollment: 30
Sex: MALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Since yoga breathing exercises are traditionally used to tranquilize the mind, and have a well-known positive effect on the cardiovascular system, it is our hypothesis that a respiratory yoga exercise named bhastrika pranayama may have positive effects on heart rate variability, electroencephalography, quality of life and salivary cortisol (stress hormone).

Detailed description: The effects of yoga interventions on heart rate variability have been previously shown in our laboratory, having its efficacy in improving autonomic heart modulation of hypertensives and elderly subjets proven. However, there is a lack of data addressing the effects of such interventions on EEG patterns of health fit male subjects, as well as there are no study investigating if there is a relationship between heart autonomic modulation changes and EEG patterns. Thus, the aim of this study was to investigate the effects of 1 month respiratory yoga training on heart rate variability, EEG, salivary cortisol and quality of life of health fit male subjets.

Eligibility criteria: Inclusion Criteria:

* Young adults;
* Physically fit (engaged in physical activity at least 2-3 times a week);
* Non athletes;
* Possibility to follow protocol agenda.

Exclusion Criteria:

* Epileptic events in previous 5 years;
* Chronic allergic rhinitis, with airway occlusion;
* Oral bronchodilator usage;
* Beta blocker user;
* Any diagnosed cardiac rhythm alteration at rest;
* Cerebral dysrhythmia;
* Previous training in respiratory yoga exercises.

Primary outcomes:
measure: Changes from baseline electroencephalography measures of brain waves at 1 and 2 months
timeFrame: baseline, one month, two months
Secondary outcomes:
measure: frequency domain heart rate variability
timeFrame: study entry, one month, two months
measure: salivary cortisol
timeFrame: study entry, one month, two months
measure: quality of life
timeFrame: study entry, one month, two months
Other outcomes:
Locations:
city: Natal
country: Brazil
facility: Universidade Federal do Rio Grande do Norte - UFRN
state: Rio Grande do Norte
Study officials:
affiliation: University of São Paulo and Federal University of Rio Grande do Norte
name: Danilo F Santaella, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03136783: New Tumor Models in Three Dimensions and in a Human Skin Environment for Personalized Melanoma Therapy
Official title: New Tumor Models in Three Dimensions and in a Human Skin Environment for Personalized Melanoma Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Melanoma (Skin)
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2017-05-02
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The choice of treatment of patients with metastatic melanoma depends on the status of B-RAF of the tumor: in the absence of mutation, treatment with immunotherapy (currently anti-PD1) is proposed in the first line; When B-RAF is mutated, treatment with targeted therapies is retained: B-RAF and MEK inhibitors are prescribed in combination (vemurafenib + cobimetinib or dabrafenib + trametinib).

Patient response rates for targeted therapies range from 50 to 60%, and the occurrence of sometimes severe side effects is not predictable. There are currently no predictive biomarkers of patients' response to targeted therapy molecules. The in vitro evaluation of the intrinsic sensitivity of the cells of patients to different combinations of targeted therapy molecules would make it possible to propose the best therapeutic combinations. The cutaneous metastases are chosen in the model because of easy access to collect tumor tissue.

The most relevant in vitro models for mimicking cutaneous melanoma metastases are explant cultures and human skin equivalents.


Eligibility criteria: Inclusion Criteria:

* Major Patients,
* patients with melanoma (stage IV) with cutaneous metastases,
* seronegative HIV, HBV, HCV, HTLV1.

Exclusion Criteria:

* Absence of cutaneous metastasis or in transit
* HIV or HBV or HCV or HTLV1 seropositivity
* Patient minor, patient under guardianship or curatorship

Primary outcomes:
measure: Evaluating in vitro the response of tumor cells to different combinations of targeted therapy molecules
timeFrame: 30 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
References:
Clinical trial NCT01298583: Ankle Tracking Training in Stroke
Official title: Ankle Tracking Training in Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stroke
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2011-02-17
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the improvement in ankle control and brain activation in subjects with stroke resulting from two different forms of telerehabilitation: tracking training, emphasizing accurate movements, versus movement training, involving simple movements.

Hypotheses:

1. The Track group will show greater improvement in ankle range of motion compared to the Move group.
2. The Track group will show greater improvement in ankle tracking accuracy and greater changes in fMRI (increase in relative volume of activation for ipsilesional sensorimotor cortex, increase in laterality index, and decrease in blood-oxygen-level-dependent (BOLD) signal intensity index) compared to Move group.
3. The Track group will show greater improvement in tracking accuracy at an untrained joint (knee) compared to the Move group.
4. The Track group will show greater improvement in standing balance.
5. The Track group will show greater improvement in walking speed and ankle dorsiflexion during gait compared to the Move group.


Eligibility criteria: Inclusion Criteria:

1. Single stroke with an ischemic infarct.
2. Between 18 and 85 years of age.
3. Time since stroke onset must be \>6 months.
4. Cannot be receiving any rehabilitation therapy.
5. Impaired ankle dorsiflexion/plantarflexion but at least 10 degrees of active motion.
6. Cognition level must be at least 24 out of 30 on the Mini-Mental Examination 7. Able to ambulate at least 100 feet independently. training.

Exclusion Criteria:

1. Cannot have any neuromuscular disorder other than stroke that impairs ankle motion.
2. Cannot have an executive function score on Stroop Interference Test of \<37.
3. Cannot have a score on the Beck Depression Inventory of \>10.
4. Cannot have ataxia, apraxia, receptive aphasia, hemi-neglect, or severe visual field cut .
5. Cannot be pregnant nor have indwelling metal or medical devices incompatible with fMRI.

Primary outcomes:
measure: ankle range of motion
timeFrame: Measurement at pretest, posttest and followup
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: James Carey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Deng H, Durfee WK, Nuckley DJ, Rheude BS, Severson AE, Skluzacek KM, Spindler KK, Davey CS, Carey JR. Complex versus simple ankle movement training in stroke using telerehabilitation: a randomized controlled trial. Phys Ther. 2012 Feb;92(2):197-209. doi: 10.2522/ptj.20110018. Epub 2011 Nov 17.
Clinical trial NCT04309383: ShuntCheck Performance Characteristics in Asymptomatic Pseudotumor Cerebri Patients
Official title: Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Pseudotumor Cerebri
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pseudotumor Cerebri
Keywords: Pseudotumor Cerebri, Ventriculoperitoneal Shunt
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: NeuroDx Development
First posted: 2020-03-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of asymptomatic PTC research subjects who have a VP shunt with a single ventricular catheter implanted for PTC and are visiting for routine care.

Brief summary: The purpose of the study is to determine if the ShuntCheck test can correctly identify flow or no flow in a ventriculoperitoneal shunt in patients with pseudotumor cerebri.

Detailed description: The purpose of the study is to determine if the ShuntCheck test can correctly identify flow or no flow in a ventriculoperitoneal shunt in patients with pseudotumor cerebri.

Flow may be limited due to slit ventricles

Eligibility criteria: Inclusion Criteria:

* 18 years old or older Adult men or women who possess a VP shunt placed for PTC;
* Capable of providing valid signed informed consent, or has a legal guardian, health care agent, or surrogate decision maker (according to local statutes, and collectively referred to as "surrogates" in this protocol) capable of providing valid, signed informed consent;
* Subjects will be asymptomatic visiting for routine care at 2-4 weeks post op

Exclusion Criteria:

* Presence of multiple shunts, or presence of more than one distal shunt catheter (regardless of function) crossing the clavicle ipsilateral to the shunt with suspected obstruction;
* ShuntCheck test would interfere with standard patient care, or emergency shunt surgery that cannot be delayed is indicated;
* Presence of an interfering open wound or edema over any portion of the VP shunt.

Primary outcomes:
measure: Specificity of ShuntCheck test
timeFrame: 15 minutes
measure: Negative Predictive Value of ShuntCheck test
timeFrame: 15 minutes
Secondary outcomes:
measure: Specificity of performing ShuntCheck test twice
timeFrame: 60 minutes
measure: Negative Predictive Value of performing ShuntCheck test twice
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida Department of Neurological Surgery and Brain Repair
state: Florida
Study officials:
affiliation: University of South Florida
name: Naomi Abel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03668197: Children Peritonitis Ecology at CHU de Rennes - (IIAPEDIA)
Official title: Children Peritonitis Ecology at CHU de Rennes - (IIAPEDIA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peritonitis
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 149
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with Intra-abdominal infection and indication for surgery or radiologically guided drainage

Brief summary: The main objectif is assess the germs (species + antibiograms) implicated in children intra-abdominal infections (community acquired or nosocomial ) at CHU de Rennes.


Eligibility criteria: Inclusion Criteria:

* Children between 0 and 18 years old
* Intra-abdominal infection with and indication for surgery or radiologically guided drainage.
* No opposition from the child or his parents

Exclusion Criteria:

* No microbiological sampling.
* Primitive peritonitis (Spontaneous bacterial peritonitis, peritonitis during peritoneal dialysis)

Primary outcomes:
measure: Blood Culture
timeFrame: 2 weeks after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
References:
Clinical trial NCT00468897: A Study To Demonstrate The Bioequivalence Of Rosiglitazone XR (BRL-049653) 8mgs XR Manufactured At Two Different Sites.
Official title: An Open-Label, Randomized, Two-Period Crossover Study to Demonstrate the Bioequivalence of a Tablet Formulation of Rosiglitazone XR (BRL-049653) 8mg Manufactured at Two Different Sites in Healthy Volunteers in Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Keywords: Alzheimers Disease
healthy volunteers
bioequivalence
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-05-03
Enrollment: 50
Sex: ALL
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 present pharmacokinetic study is designed to compare bioavailability and assess bioequivalence of two Rosiglitazone XR formulations produced at two different sites.Both formulations will be tested in fasting healthy volunteers


Eligibility criteria: Inclusion Criteria:

* Healthy male or female aged 18-55 years.
* BMI between 19 - 30 kg/m2

Exclusion criteria:

* Liver function tests above the upper limit
* Excessive alcohol consumption history
* History of Cigarette smoking
* Positive HIV, Hep B or C test
* Positive pregnancy test
* History of heparin sensitivity
* History of glucose intolerance

Primary outcomes:
measure: PK samples
timeFrame: at Pre-dose,0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32
Secondary outcomes:
measure: Safety and tolerability as measured by adverse events, vital signs clinical laboratory measurements.
timeFrame: Up to 32
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04718597: Repair of Groin Hernias After Abdominal Prostatectomy With Robotic TAPP
Official title: Lichtenstein or Robotic TAPP Repair of Groin Hernias After Abdominal Prostatectomy: a Single Centre Retrospective Comparative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inguinal Hernia
Lead sponsor: Algemeen Ziekenhuis Maria Middelares
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 43
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent robotic assisted or open inguinal hernia repair in the period March 2015 - March 2020 and previously underwent an abdominal prostatectomy.

Brief summary: This retrospective study investigates if robotic assisted groin hernia repair in patients who previously underwent abdominal prostatectomy has an equal or more favorable clinical outcome, compared to open repair in those patients.

Detailed description: In the personal practice of the investigators, there has been a decrease in open groin hernia repair from 17% to 6% since the introduction of robotic assisted surgery. This reflects a change in indication for complex hernias from an open to a minimal invasive approach. One of the typical indications for open approach before adopting the robotic platform were groin hernias after previous abdominal prostatectomy. Since prostatectomy results in scarring of the retropubic area where we need to dissect during MIS groin hernia repair, an open anterior approach is often suggested. With the enhanced view and instrument dexterity of the robotic platform, the investigators have now changed to a minimal invasive approach in these patients.

Therefore, this study will evaluate the clinical outcome after robotic assisted repair of groin hernias in patients who previously underwent an abdominal prostatectomy in comparison to open groin hernia repair.

Eligibility criteria: Inclusion Criteria:

* Adult patients
* Underwent uni-or bilateral groin hernia repair in the period March 2015 - March 2020
* Groin hernia repair via robotic assisted laparoscopy or open surgery
* History of abdominal prostatectomy before the groin hernia repair

Exclusion Criteria:

* Age below 18
* Groin hernia repair via conventional laparoscopy
* Groin hernia repair via open surgery other than Liechtenstein method
* Groin hernia repair without mesh placement

Primary outcomes:
measure: Intra-hospital complications
timeFrame: From admission until hospital discharge, on average 12-24 hours
measure: Operative time and per-operative complications
timeFrame: During the hernia repair procedure
Secondary outcomes:
measure: Early complications at home
timeFrame: Immediately post hospital discharge until 1 month postoperative
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: AZ Maria Middelares
state: Oost-Vlaanderen
Study officials:
affiliation: Algemeen Ziekenhuis Maria Middelares
name: Filip Muysoms, PhD
role: PRINCIPAL_INVESTIGATOR
References: