louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04790981: Effect of Motor Imagery Training on Ataxic Children After Medulloblastoma Resection
Official title: Motor Imagery Training is an Effective Rehabilitation Program in Treatment of Children With Cerebellar Mutism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebellar Ataxia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 50
Sex: ALL
Minimum age (years): 7
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: after resection of medulloblastoma in children they suffer from signs and symptoms of ataxia which impedes their activities of daily living.

purpose: to investigate the effect motor imagery training on balance, severity of ataxia and gait parameters on children after resection of medulloblastoma.

Methods: Fifty children surfing from cerebellar ataxia after medulloblastoma resection were selected from tumors hospital of Cairo University, their age ranged from seven to nine years old, they were randomly assigned into two matched control and study groups. The control groups received the selected physical therapy program while, the study group received motor imaginary training in addition to the selected physical therapy program. Both groups were evaluated by ataxic rating scale, pediatric berg balance scale and kinematic gait analysis by kinovea software.

Detailed description: Motor imagery is an effective method to enhance motor performance applied in rehabilitation programs it did not impose a physical load on patients, was confirmed through clinical evidence from meta-analysis. Motor imagery means thinking in motor task with executing it to activate motor cortical areas as 25% of the brain neurons are mirror neurons and fire by thinking.

Eligibility criteria: Inclusion Criteria:

* The children had signs of ataxia
* loss of balance
* able to understand and execute test instructions
* the children are in the follow up period after medulloblastoma resection.

Exclusion Criteria:

* medically unstable
* visual impairment
* increased intracranial pressure
* any other neuromuscular diseases.

Primary outcomes:
measure: Severity of ataxia
timeFrame: 3 months
measure: Pediatric berg balance scale
timeFrame: 3 months
measure: step length (cm)
timeFrame: 3 months
measure: step width (cm)
timeFrame: 3 months
measure: foot angle (degree)
timeFrame: 3 months
measure: Cadence (steps/min)
timeFrame: 3 months
measure: Gait velocity (cm/sec)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
affiliation: Assistant Professor, Faculty of Physical Therapy, Cairo University
name: Reham Alsakhawi, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00519181: Safety and Efficiency Study of Valproic Acid In HAM/TSP
Official title: Open Label Study of the Clinical and Laboratory Effects of Valproic Acid In HAM/TSP
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: HTLV-I-Associated Myelopathy
Keywords: HTLV
HAM/TSP
VALPROIC ACID
PROVIRAL LOAD
Lead sponsor: University Hospital Pierre Zobda-Quitman
Sponsor class: OTHER
First posted: 2007-08-22
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Reversible acetylation of the histone tails plays an important role in the control of specific gene expression. Mounting evidence has established that histone deacetylase inhibitors such as Valproic Acid (VPA)selectively induce cellular differentiation and apoptosis in variety of cancer cells. In a single-center, one year open-label trial, 19 HAM/TSP patients were treated with oral doses of VPA (20mg/Kg/day). Primary end-points were the therapeutic safety and the effect on HTLV-1 proviral load (a significant and sustained decrease was expected). Secondary end-point was the neurological status before and after one-year treatment.


Eligibility criteria: Inclusion Criteria:

* HAM/TSP patients diagnosed on WHO criteria
* Obtained informed consent.

Exclusion Criteria:

* Patients with hepatic or nephrologic disease
* Valproic Acid allergy
* Pregnancy.

Primary outcomes:
measure: Clinical and laboratory safety of Valproic Acid in HAM/TSP. Effect on HTLV-1 proviral load in peripheral blood mononuclear cells.
timeFrame: one year
Secondary outcomes:
measure: Neurological outcome.
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital Pierre Zobda-Quitman, Fort de France
name: Stephane OLINDO, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lezin A, Gillet N, Olindo S, Signate A, Grandvaux N, Verlaeten O, Belrose G, de Carvalho Bittencourt M, Hiscott J, Asquith B, Burny A, Smadja D, Cesaire R, Willems L. Histone deacetylase mediated transcriptional activation reduces proviral loads in HTLV-1 associated myelopathy/tropical spastic paraparesis patients. Blood. 2007 Nov 15;110(10):3722-8. doi: 10.1182/blood-2007-04-085076. Epub 2007 Aug 23.
Clinical trial NCT06876181: In Vivo Study of Local Tranexamic Acid Concentrations Following Intra-Articular Administration in Total Knee Arthroplasty
Official title: In Vivo Study of Local Tranexamic Acid Concentrations Following Intra-Articular Administration in Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Local Concentration of Tranexamic Acid Following Intra-articular Administration in TKA
Keywords: Tranexamic acid
Intra-articular administration
topical administration
Local concentration
Elimination half-time
Lead sponsor: Valdoltra Orthopedic Hospital
Sponsor class: OTHER
Collaborators: name: University of Ljubljana, Faculty of Medicine
First posted: 2025-03-14
Enrollment: 48
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Participants were recruited from Valdoltra Orthopaedic Hospital between August 2022 and March 2023.

Brief summary: The goal of this observational study is to measure local tranexamic acid (TXA) concentrations following intra-articular administration in patients undergoing total knee arthroplasty. By evaluating its pharmacokinetic profile in the periarticular hematoma, the study will also assess the safety of topically administered TXA considering its cytotoxicity in healthy periarticular tissue. The main questions it aims to answer are:

* How does TXA concentration in periarticular hematoma change over time following intra-articular administration after TKA?
* Do local TXA concentrations after standard intra-articular dose of 2 g exceed the proposed cytotoxic levels, and for how long?

Participants will:

* Receive standard 2 g of TXA intra-articularly at the end of surgery as per the estabished hospital protocol
* Undergo intra-articular hematoma fluid sampling via a drainage catheter at 0.5, 1.5, 3, 6, and 9 hours postoperatively


Eligibility criteria: Inclusion Criteria:

* diagnosis of advanced osteoarthritis of the knee joint

Exclusion Criteria:

* known allergy to TXA
* family history or past spontaneous thromboembolic event
* pathological preoperative blood analysis
* advanced heart failure (NYHA \> 2)
* ischemic heart disease
* epilepsy

Primary outcomes:
measure: Tranexamic acid concentrations in periarticular hematoma at 0.5, 1.5, 3, 6, and 9 hours following a standard intra-articular injection of 2 g of tranexamic acid
timeFrame: From the collection of samples after the total knee arthroplasty procedure to the analysis of hematoma samples within 2-3 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankaran
country: Slovenia
facility: Valdoltra Orthopaedic Hospital
state: Ajdovscina
Study officials:
References:
Clinical trial NCT04707781: Database for Interstitial Lung Disease
Official title: Clinical Database for the Early Recognition of Pulmonary Parenchymal Involvement in Patients with Systemic Diseases Bearing a Risk for Interstitial Lung Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Diseases, Interstitial
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
First posted: 2021-01-13
Enrollment: 412
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients (females and males; above 18 yrs) with a known systemic disease bearing a risk for ILD but without diagnosed ILD and patients (females and males; above 18 yrs) with diagnosed ILD.

Brief summary: The purpose of this study is to establish a clinical database for patients bearing at risk for ILD (Interstitial Lung Disease) and to set up a prospective ILD Screening program for these patients.


Eligibility criteria: Inclusion Criteria:

* Age: ≥ 18 years
* patients with a known systemic disease bearing a risk for ILD
* signed informed consent (for prospective part)

Exclusion Criteria:

* Age \< 18 years
* comorbidities severely limiting life-expectancy (e.g. severe cardiovascular conditions, malignant disease)

Primary outcomes:
measure: DLCO%pred (carbon monoxide diffusing capacity) at time of ILD diagnosis
timeFrame: 5 years
Secondary outcomes:
measure: FVC%pred (Forced vital capacity) at time of ILD diagnosis
timeFrame: 5 years
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz, Department of Internal Medicine, Division of Pulmonology
Study officials:
References:
Clinical trial NCT06669481: Correlation Between Preoperative Images of PPGL and Intraoperative Hemodynamics
Official title: Semiquantitative 131I-MIBG Scintigraphy Predicts Intraoperative Blood Pressure Fluctuation in Patients Undergoing Surgery for Pheochromocytoma and Paraganglioma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pheochromocytoma
Paraganglioma
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 159
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 with suspected PPGLs who received 131I-MIBG scintigraphy and were treated by surgery

Brief summary: This is a retrospective observational cohort study involving patients with suspected PPGLs who underwent 131I-MIBG scanning and surgical treatment between January 2020 and April 2023. The objective is to evaluate the correlation between MIBG imaging score and intraoperative hemodynamic fluctuations.

Detailed description: This is a retrospective observational cohort study involving patients with suspected PPGLs who underwent 131I-MIBG scanning and surgical treatment between January 2020 and April 2023. The objective is to evaluate the correlation between MIBG imaging score and intraoperative hemodynamic fluctuations.

Eligibility criteria: Inclusion Criteria:

* Patients with suspected PPGLs who received 131I-MIBG scintigraphy and were treated by surgery

Exclusion Criteria:

* 1) surgery was performed more than 6 months after 131I-MIBG scintigraphy; 2) tumor located in bladder where radioactive urine would influence assessment of tumor; 3) tumor was not resected as a whole; 4) resected tumor was not PPGLs confirmed by pathology; 5) 131I-MIBG scintigraphy images or intraoperative BP was not available for assessment.

Primary outcomes:
measure: Difference of SBP ARV and MAP ARV in Different Groups
timeFrame: Intraoperative systolic blood pressure (SBP) and diastolic blood pressure (DBP) were recorded automatically in a 5 min interval from the beginning to the end of surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking union medical college hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01091181: The Effect of Hysterotomy Technique on the Rate of Large Defects in the Hysterotomy Scar
Official title: The Effect of Hysterotomy Technique on the Rate of Large Defects in the Hysterotomy Scar
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scars
Keywords: Caesarean
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2010-03-23
Enrollment: 122
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: women aimed for emergency cesarean section were randomized into two groups according to surgery technique of opening the uterus: 1 Group - high level of hysterotomy incision; 2 Group - low level of hysterotomy incision. Opening and closing of abdomen performed in the same manner in both groups
Primary purpose: OTHER

Brief summary: The Effect of Cesarean Operative Technique on the Occurrence of Large Hysterotomy Scar Defects.

Detailed description: Having a Caesarean leads to a scar in the uterus, which does not always heal properly. Defective healing can lead to serious complications in the next pregnancy and delivery. Different surgical techniques can be used for a Caesarean section.

The aim is to compare two surgical techniques (different ways of opening the uterus), to investigate whether one or the other technique leads to fewer defective scars in the uterus. Both these techniques are in use at the clinic. After the operation, patients are cared for in the normal way.

Six months after the Caesarean, patients are examined using vaginal ultrasound. Vaginal ultrasound allows to see if the scar after the Caesarean has healed well, or if there are defects in it.

Eligibility criteria: inclusion criteria:

* ≥ 18 years old
* gestational age ≥ 37 gestational weeks
* cervical dilatation ≥5 cm,
* no previous uterine surgery other than cone biopsy, loop electrosurgical excision procedure, dilatation and curettage, or dilatation and evacuation, undergoing emergency caesarean section.

exclusion criteria:

• need of immediate caesarean section, defined as delivery of the baby within 20 minutes.

Primary outcomes:
measure: large defect
timeFrame: 6 months
Secondary outcomes:
measure: APGAR score
timeFrame: 1 and 5 minute after delivery
measure: blood loss
timeFrame: 1 hour
measure: difficulties at delivery of fetus
timeFrame: 1 hour
measure: postoperative infection
timeFrame: 8 weeks
measure: readmission to the hospital
timeFrame: 8 weeks
measure: miscarriage
timeFrame: up to 8 years
measure: scar pregnancy
timeFrame: up to 8 years
measure: placenta previa/accreta
timeFrame: up to 8 years
measure: uterina rupture/uterine dehiscence
timeFrame: up to 8 years
measure: vaginal delivery after caesarean
timeFrame: up to 8 years
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Skåne University Hospital Malmö
Study officials:
affiliation: Skane University Hospital
name: Olga Vikhareva, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02093481: Effects of Dietary Fibre on Glucose Metabolism and Satiety
Official title: Intrinsic Indigestible Carbohydrates as Means to Modulate Colonic Events, With Specific Focus on Metabolism and Satiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Obesity
Metabolic Syndrome
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2014-03-21
Enrollment: 19
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The experimental model is a semi-acute study where the purpose of the study is to evaluate food factors related to colonially derived regulation of glucose metabolism (and related parameters) and satiety in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Normal fasting blood glucose, BMI 19-25 kg/m2

Exclusion Criteria:

* Gastrointestinal diseases or food allergies e.g. lactose-, gluten intolerance, metabolic disorders e.g. diabetes, tobacco/snuff users. Antibiotic or probiotic usage within two weeks, and during study. Vegetarians.

Primary outcomes:
measure: Blood glucose
timeFrame: Postprandial 0-180 min after breakfast
measure: Insulin
timeFrame: Postprandial 0-180 min after breakfast
measure: Appetite hormones
timeFrame: Postprandial 0-180 min after breakfast
measure: Markers of colonic fermentation and inflammation
timeFrame: Postprandial 0-180 min after breakfast
Secondary outcomes:
measure: Subjective satiety
timeFrame: Postprandial 0-180 min after breakfast
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Applied Nutrition and Food Chemistry, Lund Univeristy
state: SE
Study officials:
affiliation: Lund Univeristy
name: Anne Nilsson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sandberg JC, Bjorck IM, Nilsson AC. Rye-Based Evening Meals Favorably Affected Glucose Regulation and Appetite Variables at the Following Breakfast; A Randomized Controlled Study in Healthy Subjects. PLoS One. 2016 Mar 18;11(3):e0151985. doi: 10.1371/journal.pone.0151985. eCollection 2016.
Clinical trial NCT02695381: Etodolac-lidocaine Patch in Subjects Experiencing Acute Delayed Onset Muscle Soreness
Official title: A Randomized, Double-blind, Multiple-dose, Placebo-controlled Study to Evaluate the Efficacy and Safety of Etodolac-lidocaine Patch Applied Once Daily in Subjects Experiencing Acute Delayed Onset Muscle Soreness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Delayed Onset Muscle Soreness (DOMS)
Lead sponsor: MEDRx USA, Inc.
Sponsor class: INDUSTRY
First posted: 2016-03-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study evaluate the efficacy and safety of Etodolac-lidocaine topical patch applied one time daily when compared with placebo in the treatment of acute Delayed Onset Muscle Soreness (DOMS) of the upper limbs.


Eligibility criteria: Inclusion Criteria:

* Have not engaged in significant upper extremity fitness activities for more than two times per week for ≥ 2 consecutive weeks in the past 6 months prior to screening.
* Subject has a body mass index of between 18 and 30 kg/m2, inclusive.
* Subjects who report a pain with movement score in both arms of at least 5 (based on a 0-10 NRS) secondary to DOMS approximately 24 to 30 hours after each arm was exercised.

Exclusion Criteria:

* Presence of another painful physical condition that, in the opinion of the Investigator, may confound study assessments.
* Use of pain medication (including anti-inflammatory drugs) prior to the Exercise Visit until 72 hours after randomization.
* Use of any corticosteroids (oral, injectable, topical, inhaled) from before the Exercise Visit until randomization. Corticosteroids must be washed out by at least 3 days before the Exercise Visit.
* Chronic or acute renal or hepatic disorder, inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) or a significant coagulation defect.
* History of allergy (cutaneous or systemic), asthma, hypersensitivity to any of the following: etodolac, lidocaine, paracetamol (acetaminophen), acetylsalicylic acid, salicylic acid, other NSAID, other local anesthetic, known intolerance (cutaneous or systemic) to any of the ingredients in the patch.

Primary outcomes:
measure: Sum of the time-weighted differences from baseline in pain intensity with movement (SPIDMove) over 0-24 hours post-T0 (SPIDMove 0-24 hours).
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Lotus Clinical Research
state: California
Study officials:
affiliation: Lotus Clinical Research, LLC
name: Paulette Saddler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04774081: Development of a Novel Method to Measure Insulin Sensitivity in Humans: A Pilot Study
Official title: Development of a Novel Method to Measure Insulin Sensitivity in Humans: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Insulin Sensitivity
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 13
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: Participants will be recruited among those whose insulin sensitivity has been previously measured by a high-dose euglycemic-hyperinsulinemic clamp at Pennington Biomedical during the last 5 years and indicated their wiliness to be re-contacted for future research

Brief summary: This study will determine whether the ratio between 24h C-peptide urinary excretion rate and average 24h circulating glucose represent a good correlate of what is measured by the gold standard, i.e. M (glucose disposal rate) from a euglycemic-hyperinsulinemic clamp


Eligibility criteria: Inclusion Criteria:

* Healthy male or female
* Age 18-65 y
* BMI between 20 kg/m2 and 35 kg/m2 (inclusive)
* Are willing to consume pre-prepared meals
* Have completed a high-dose (≥80 mIU/m2/min) euglycemic-hyperinsulinemic clamp during the last five years at Pennington Biomedical. The data from the previous PBRC clamp will be pulled and used in conjunction with data from this study.
* Willing to have blood and urine stored for future use

Exclusion Criteria:

* Major lifestyle changes since the euglycemic-hyperinsulinemic clamp was performed (i.e. gain/lost weight, stopped smoking, began/stop exercise).
* Unstable weight in the last 3 months \[gain or loss \>10 lb (or 4.5 kg)\]
* Diagnosed with diabetes
* Untreated hypertension and average screening blood pressure \>140/90 mmHg
* Previous bariatric surgery (or other surgeries) for obesity or weight loss
* Chronic use of medications affecting metabolism or sleep\*
* History of neurological disease
* History of cardiovascular disease, or other chronic diseases, that might affect pancreatic or glucose metabolism.
* Pregnant, planning to become pregnant, or breastfeeding
* Adherence to special restrained diets (e.g., low-CHO, low-fat, or vegetarian/vegan diets) over the last 3 months. \*Sporadic use of these medications is fine (however, enrollment will depend on a case-by-case basis). If taking sporadically, participants should not be taking the medication for 1-month prior to the first visit.

Primary outcomes:
measure: Glycemia (Continuous Glucose Monitoring)
timeFrame: 24 hours
measure: Urinary C-peptide
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
measure: M-value at a high-dose (≥80 mIU/m2/min) euglycemic-hyperinsulinemic clamp.
timeFrame: Up to 5 years before the CGM and C-peptide assessment
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
References: