louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05081791: Exercise Therapy for Patients with Muscle Dystrophies
Official title: Effects of Exercise Therapy on Functional Capacity, Muscle Strength and Patient-reported Outcomes in Patients with Muscle Dystrophies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscular Dystrophies
Keywords: exercise therapy
muscle strength
exercise tolerance
muscular dystrophies
Lead sponsor: Universitat Pompeu Fabra
Sponsor class: OTHER
Collaborators: name: Hospital Clinic of Barcelona
First posted: 2021-10-18
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Muscular Dystrophies (MD) are a heterogeneous group of diseases characterised by muscle wasting that lead to progressive loss of function. Although exercise training has been traditionally neglected to these patients due to concerns regarding muscle damage, research has shown that exercise therapy is safe and tolerable in this population and can lead to potential gains in endurance and muscle strength, as well as other patient-reported outcomes such as health-related quality of life.Therefore, in this study, the investigators aim to examine the feasibility, tolerability and safety as well as the effects of a 12-week, exercise-training program in patients with MD on functional capacity, muscle strength, and health-related quality of life.


Eligibility criteria: Inclusion Criteria:

* Clinical or Genetically diagnosis of Muscular Dystrophy including Limb-Girdle type I and type II, Myotonic Dystrophy type I and type II and facioscapulohumeral dystrophy.
* Age \> 18 years old
* Ability to walk independently for 10 or more metres

Exclusion Criteria:

* Inability to understand or read Spanish/Catalan.
* Patients engaging in a similar exercise-based program in the past 12 months
* Patients with severe cognitive, neurological or musculoskeletal impairment unable to participate in the exercise program
* Unstable respiratory, cardiovascular or metabolic disease

Primary outcomes:
measure: Timed Up and Go
timeFrame: 1 week post-intervention
Secondary outcomes:
measure: Short Physical Performance Battery
timeFrame: 1 week post-intervention
measure: Upper Body Muscle Strength
timeFrame: 1 week post-intervention
measure: Lower Body Muscle Strength
timeFrame: 1 week post-intervention
measure: Handgrip Strength
timeFrame: 1 week post-intervention
measure: Health-Related Quality of Life
timeFrame: 1 week post-intervention
measure: Body Weight
timeFrame: 1 week post-intervention
measure: Body Mass Index
timeFrame: 1 week post-intervention
measure: Percentage of fat-free mass
timeFrame: 1 week post-intervention
measure: Percentage of fat mass
timeFrame: 1 week post-intervention
measure: Fatigue
timeFrame: 1 week post-intervention
measure: Respiratory Muscle Strength
timeFrame: 1 week post-intervention
measure: Physical Activity Levels
timeFrame: 1 week post-intervention
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
Study officials:
References:
Clinical trial NCT01820091: Phase 1 Study of Fusilev® to Prevent or Reduce Mucositis in Patients With Non-Small Cell Lung Cancer Receiving Folotyn®
Official title: An Open Label, Multicenter, Dose Finding, Single Arm, Phase 1 Study of Fusilev® (Levoleucovorin) to Prevent or Reduce Mucositis in Patients With Relapsed or Refractory Non-Small Cell Lung Cancer Receiving Folotyn® (Pralatrexate)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Acrotech Biopharma Inc.
Sponsor class: INDUSTRY
First posted: 2013-03-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To determine the optimal dose and schedule of Fusilev to prevent or reduce Folotyn-related Grade 3 or higher oral mucositis in patients with Non-Small Cell Lung Cancer.

Detailed description: This is an open-label, uncontrolled, nonrandomized, multicenter, dose-finding, single-arm, Phase 1 study primarily to determine the optimal dose and schedule of Fusilev to prevent or reduce Folotyn-related Grade 3 or higher oral mucositis.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Relapsed or Refractory Non Small Cell Lung Cancer (NSCLC) after at least one line of therapy
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Histologically or cytologically confirmed Stage III B/IV NSCLC
* Adequate hematological, hepatic, and renal function
* Available during the first 8 weeks of the study treatment period to visit the clinic for oral Mucositis assessments on scheduled days

Exclusion Criteria:

* Active concurrent malignancy. If there is a history of prior malignancies other than those exceptions listed above, the patient must be disease-free for at least 5 years
* Congestive heart failure
* Uncontrolled hypertension
* Known human immunodeficiency virus (HIV)-positive diagnosis
* Previous exposure to Pralatrexate
* Pregnant or breast-feeding women
* Major surgery within 14 days of enrollment
* Active uncontrolled infection, underlying medical condition, or other serious illness that would impair the ability of the patient to receive protocol treatment
* Symptomatic central nervous system (CNS) metastases or lesions for which treatment is required. Patients who received prophylactic CNS treatment are eligible

Primary outcomes:
measure: Optimal dose and Schedule of Fusilev to prevent or reduce Oral Mucositis
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: Impact of Fusilev on the number of Folotyn-related dose modifications secondary to oral mucositis
timeFrame: Up to 8 weeks
measure: Impact of Fusilev on the frequency of Oral Mucositis
timeFrame: Up to 8 weeks
measure: Impact of Fusilev on use of Analgesics for Oral Mucositis
timeFrame: Up to 8 weeks
measure: Impact of Fusilev on number of Folotyn doses delivered
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02069691: The Cycling Exercise With Virtual Reality Visual Stimulation for Rehabilitation in CVA Patients
Official title: Institutional Review Board of Chung Shan Medical University Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke,
rehabilitation,
leg cycling,
feedback,
virtual reality
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2014-02-24
Enrollment: 13
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Background: Hemiplegia is one of the main reasons why stroke survivors lose their walking and balancing ability. Many studies point out that cycling is an effective means for lower limb rehabilitation. However, during training, the unaffected limb may compensate for the affected one resulting in suboptimal rehabilitation. To address this issue, the investigators developed the virtual reality-cycling training system (VRCTS) which can acquire force and speed signals in real-time through a cycling module. The system then analyzes the acquired data and uses a 3D VR rehabilitation program to help patients to train their affected side. The aim of the study was to develop the VRCTS, verify its function and test system function on both normal subjects and stroke patients.

Methods: In this system, the investigators designed a cycling device that is embedded with load cell and encoder sensors to detect cycling force and angle in real-time. A Cycling Graph User Interface Control and Data Recode System (Cycling CR System) was applied for signal analysis and feedback control. The investigators designed a 3D interactive VR rehabilitation program that can guide and train the users through visual feedback. Each user performed a pre-test to examine determine condition, left-right balance and other parameters, which allows the system to be customized.


Eligibility criteria: Inclusion Criteria:

* single stroke with unilateral hemiplegia (Brunnstrom stage III);
* hypertonia in the affected leg, modified Ashworth scale (MAS) grade ≦ 2;
* no significant perceptual, cognitive, or sensory deficits;
* no history of osteoarthritis, severe cardiopulmonary disease, or vascular disease in lower limbs
* lack of a fixed contracture in the affected lower limb

Primary outcomes:
measure: pedal force of affected leg
timeFrame: up to 24 weeks
Secondary outcomes:
measure: asymmetrical ratio index
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
Study officials:
References:
Clinical trial NCT00456729: Malabsorption as a Cause of Iron Treatment Failure in Infants
Official title: Malabsorption as a Cause of Iron Treatment Failure in Infants - A Clinical Observational Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency
Malabsorption
Keywords: Iron deficiency
Malabsorption
Giardiasis
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2007-04-05
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Infants should receive prophylacatic iron supplementation since age 4 months till one year. Patients suffering from malabsorption, mainly Giardia infestation may develop iron deficiency resistent to further iron treatment. The purpose of this study is to assess the incidence of malabsorption in those infants and to examine the results of empiric treatment with metronidazole.


Eligibility criteria: Inclusion Criteria:

* All infants referred to the Pediatric Hematology Unit because lack of response to iron treatment.

Exclusion Criteria:

* Patients diagnosed with specific malabsorption causes like Celiac or Cystic Fibrosis.

Primary outcomes:
measure: Hgb level
Secondary outcomes:
measure: Iron level
measure: Ferritin Level
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center
Study officials:
affiliation: Pediatric Hematology Unit, Ha'Emek Medical Center
name: Ariel Koren, MD
role: STUDY_DIRECTOR
affiliation: Pediatric Hematology Unit - Ha'Emek Medical Center
name: Carina Levin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pediatric Dpt B - Ha'Emek Medical Center
name: Tania Hanchis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01812629: Nutritional Management of Children With Chronic Diarrhea
Official title: Clinical Management of Children With Chronic Diarrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth and Tolerance Infant Study
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2013-03-18
Enrollment: 19
Sex: ALL
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study objective is to assess the growth, tolerance and efficacy of a complete amino acid-based medical food in children with chronic diarrhea.


Eligibility criteria: Inclusion Criteria:

* Less than or equal to 9 months of age at enrollment
* Candidates for an elemental formula
* Chronic diarrhea and diagnosis of one of the following conditions: short-bowel syndrome, eosinophilic gastroenteritis, food allergy, inflammatory bowel disease, pancreatic disease, protein maldigestion, HIV-advanced disease or other underlying GI disease with chronic diarrhea controlled by a semi-elemental or elemental formula
* Parents agree to feed infant with experimental formula for least 50% of total calories during study period

Exclusion Criteria:

- Any non-approved concomitant study

Primary outcomes:
measure: Physician determined target outcome
timeFrame: Study Day (SD)1-84
Secondary outcomes:
measure: Dietary Assessment
timeFrame: Study day (SD) 2-4, 5-7, 25-27 and 81-83
measure: Gastro-Intestinal Tolerance
timeFrame: Study Day (SD) 2-4, 5-7, 25-27, 81-83
measure: Stool characteristics
timeFrame: Study Day (SD) 2-4, 5-7, 25-27 and 81-83
measure: Blood Chemistry
timeFrame: Study Day (SD) 1 and 84
measure: Anthropometrics
timeFrame: Study Day (SD) 1, 28 and 84
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Abbott Nutrition
name: Marlene Borschel, PhD, RD
role: STUDY_CHAIR
References:
citation: Borschel MW, Antonson DL, Murray ND, Oliva-Hemker M, Mattis LE, Kerzner B, Tolia V, Baggs G. Two single group, prospective, baseline-controlled feeding studies in infants and children with chronic diarrhea fed a hypoallergenic free amino acid-based formula. BMC Pediatr. 2014 May 29;14:136. doi: 10.1186/1471-2431-14-136.
Clinical trial NCT03554629: A Comparison of Capnography Sampling Lines
Official title: A Comparison of Capnography Sampling Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Capnography
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2018-06-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study evaluates the performance of eight (8) cleared capnography carbon dioxide (CO2) sampling filterlines during patient simulated scripted activities when connected to a Medtronic (MDT) dual parameter monitor.

Detailed description: The eight (8) Capnography CO2 Sampling Filterlines (CCSF) have different designs for obtaining a gas sample for CO2 measurement and also for delivering supplemental oxygen (O2).

In this study awake, healthy volunteers will evaluate the 8 CCSF (Capnography CO2 Sampling Filterline) to determine their performance variability in providing a representative exhaled CO2 sample for measurement on the Capnostream 35 dual parameter monitor during scripted activities of closed mouth/open mouth breathing during both high and low respiration rate with supplemental oxygen delivery at 5lpm.

Eligibility criteria: Inclusion Criteria:

1. Non-hospitalized adults ≥ 18 years old.
2. Willing and able to give informed consent.

Exclusion Criteria:

1. Lack of an informed consent.
2. Subjects not able to accommodate the proper application of the cannula.
3. Subject not willing or able to comply fully with the study procedures.
4. Subjects with sensitivity to nasal cannula in both nares.
5. Subject with skin allergies to medical adhesives.
6. Subjects with runny nose the day of the study participation.
7. Subject, who in the opinion of the Principal Investigator, should not be enrolled.

Primary outcomes:
measure: Capnography Measured CO2 Waveform Data as a Function of CO2 Cannula Sampling Filterline (CCSF) Stratified by Activity
timeFrame: Three hours
Secondary outcomes:
measure: Average Number of Alarms as a Function of Each Capnography CO2 Cannula Sampling Filterline (CCSF) Stratified by Activity With an Actual Respiration Rate of 24
timeFrame: Three hours
measure: Average Number of Alarms as a Function of Each Capnography CO2 Cannula Sampling Filterline (CCSF) Stratified by Activity With an Actual Respiration Rate of 6
timeFrame: Three hours
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Clinimark LLC
state: Colorado
Study officials:
affiliation: Clinimark, LLC
name: Thomas A Miner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03039829: Safety of Different Forms of Creatine
Official title: Short-Term Safety and Dose Effects of Different Forms of Creatine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutritional Supplements
Lead sponsor: Texas A&M University
Sponsor class: OTHER
Collaborators: name: Nutrabolt
First posted: 2017-02-01
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will aim to determine whether ingesting creatine nitrate (CrN) at higher doses will differentially affect hemodynamic variables compared to a placebo.

Detailed description: This study will examine the short-term (7 day) characteristics of ingesting creatine nitrate (CrN) compared to placebo on Chem-15 blood safety, heart rate, blood pressure, heart rate and blood pressure reactivity and self-reported side effects.

Eligibility criteria: Inclusion Criteria:

* Apparently healthy
* At least 6 months immediate prior history of resistance training including bench press and leg press or squat

Exclusion Criteria:

* A history of treatment for metabolic disease (i.e., diabetes), hypertension, hypotension, thyroid disease, arrhythmias and/or cardiovascular disease
* Use of prescription medication (birth control is allowed)
* Pregnant or nursing or plan to become pregnant during the next month
* Creatine or nitrate use in the last eight weeks
* History of smoking
* History of drinking (i.e., 12 drinks per week or more)
* Use of nonsteroidal anti-inflammatory drugs (NSAIDs) including ibuprofen (Advil, Motrin, Nuprin, etc.), indomethacin (Indocin), naproxen (Aleve, Anaprox, Naprelan, Naprosyn), piroxicam (Feldene)

Primary outcomes:
measure: Measuring the blood pressure response to creatine nitrate ingestion
timeFrame: 7 days
measure: Measuring the heart rate response to creatine nitrate ingestion
timeFrame: 7 days
Secondary outcomes:
measure: Measuring a blood chemistry panel 15 response to creatine nitrate ingestion
timeFrame: 7 days
measure: Measuring the one Repetition Maximum (1 RM) muscle strength response to creatine nitrate ingestion
timeFrame: 7 days
measure: Measuring the repetitions to failure muscle endurance response to creatine nitrate ingestion
timeFrame: 7 days
measure: Measuring self-reported side effects of creatine nitrate ingestion
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
affiliation: Texas A&M University
name: Richard B Kreider, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06820229: Adjunctive Methods In Treatment Of Odontogenic Keratocyst
Official title: 5-Fluorouracil Cream Versus Modified Carnoy's Solution As Adjunctive Methods In Treatment Of Odontogenic Keratocyst
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Keratocysts of the Jaw
Keywords: Odontogenic keratocyst
topical 5-fluorouracil
modified carnoy's solution
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare both clinically and radiographically the effect of using 5- fluorouracil cream (5-FU) versus modified carnoy's solution (MCS) as adjunctive methods in treatment of odontogenic keratocyst (OKC).

Patients and methods :This is an interventional, comparative study that was carried on 20 patients with mandibular odontogenic keratocyst and were divided randomly into two equal groups, Group I: included 10 patients in whom OKCs were treated with enucleation and peripheral ostectomy followed by application of 5-FU cream. Group II: included 10 patients in whom OKCs were treated with enucleation and peripheral ostectomy followed by application of MCS. All patients were followed up for 9 months postoperatively.


Eligibility criteria: Inclusion Criteria:

* patients with biopsy proved odontogenic keratocyst

Exclusion Criteria:

* relevant systemic diseases which might affect healing process.

Primary outcomes:
measure: degree of pain pain
timeFrame: 6 month
measure: swelling
timeFrame: 6 month
Secondary outcomes:
measure: Quantitative computed tomography (CT)
timeFrame: 12 month
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: Gharbia
Study officials:
affiliation: Tanta University
name: Mohamed K Allam, Ass prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00599729: Measurement of Gait Spatio-Temporal Characteristics in Knee Osteoarthritis Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knee Osteoarthritis
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-01-24
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with knee osteoarthritis evaluated by an orthopedic surgeon. patient will be recruted from the outpatient clinic at "asaf Harofe" medical center, Zrifin, Israel and APOS medical center, Herzlya, Israel

Brief summary: The purpose of the study is to evaluate the gait spatio-temporal parameters of patients with degenerative changes in the knee joint and to relate them with 2 questionares (WOMAC and SF-36).


Eligibility criteria: Inclusion Criteria:

* Symptomatic knee OA for at least 6 months
* Fulfilled American College of Rheumatology clinical criteria for OA of the knee
* Radiographically assessed OA of the knee graded 1-4 according to the Kellgren \& Lawrence scale

Exclusion Criteria:

* Acute septic arthritis
* Patients with an increased tendency to fall
* Lack of physical or mental ability to perform or comply with the treatment procedure
* Diabetes mellitus
* History of pathological osteoporotic fracture

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Herzliya
country: Israel
facility: APOS Medical Center
city: Zrifin
country: Israel
facility: "Asaf Harofeh" Medical center
Study officials:
affiliation: "asaf Harofe" Medical Center, Zrifin, Israel
name: Nahum Halperin, Prof (MD)
role: STUDY_CHAIR
References:
citation: Elbaz A, Mor A, Segal O, Agar G, Halperin N, Haim A, Debbi E, Segal G, Debi R. Can single limb support objectively assess the functional severity of knee osteoarthritis? Knee. 2012 Jan;19(1):32-5. doi: 10.1016/j.knee.2010.12.004. Epub 2011 Jan 26.
citation: Debi R, Mor A, Segal O, Segal G, Debbi E, Agar G, Halperin N, Haim A, Elbaz A. Differences in gait patterns, pain, function and quality of life between males and females with knee osteoarthritis: a clinical trial. BMC Musculoskelet Disord. 2009 Oct 13;10:127. doi: 10.1186/1471-2474-10-127.