louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00205205: Peer Mentoring for Persons With Spinal Cord Injury (SCI)
Official title: Peer Mentoring for Persons With Spinal Cord Injury: Program Satisfaction and Outcome for Mentor/Mentee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A peer mentoring program for persons with SCI was developed. Individuals who experienced SCI in the past and have adapted well functionally were asked to serve as mentors for individuals with newly-acquired SCI. These individuals undergo volunteer and peer mentoring training prior to mentoring activities. They are a subset of the study participants. We are tracking their satisfaction with life, positive and negative affect, life adjustment, depression, and social support over time. We hypothesize that measures of adjustment will become more positive as involvement as a mentor increases. The second subset of study participants are the individuals with newly-acquired SCI. They complete a baseline assessment of the measures listed above and then at 6 months, one year, and two years after match with a mentor. We also collect information about the quantity and quality of the mentoring sessions from both the mentor and mentee. We hypothesize that the mentee's adjustment will be positively influenced by the number and quality of the mentoring sessions. Due to the relatively small number of SCI per year in our program, we opted to offer the mentoring program to all individuals with newly acquired SCI, thus there is no control group.


Eligibility criteria: Inclusion Criteria:

* experienced a SCI

Exclusion Criteria:

* no severe traumatic brain injury
* no severe psychiatric disturbance

Primary outcomes:
measure: satisfaction with life, positive and negative affect, life adjustment, depression, and social support
Secondary outcomes:
measure: is the mentee's adjustment positively influenced by the number and quality of the mentoring sessions
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Jack Sherman
role: PRINCIPAL_INVESTIGATOR
References:
citation: Veith, E.M., Sherman, J.E., Pellino, T.A. Yasui, T.Y. (2006). Qualitative analysis of the peer-mentoring relationship among individuals with spinal cord injury, Rehabilitation Psychology, 51, 289-298.
Clinical trial NCT04466605: Effect of Tele-Yoga Therapy on Patients With Chronic Musculoskeletal Pain During Covid-19 Lockdown
Official title: Effect of Tele-Yoga Therapy on Patients With Chronic Musculoskeletal Pain During Covid-19 Lockdown: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Musculoskeletal Pain
Keywords: Tele-Yoga Therapy
Chronic musculoskeletal pain
Randomized controlled trial
Lead sponsor: Aarogyam UK
Sponsor class: OTHER
Collaborators: name: NMP Medical Research Institute
name: Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University
First posted: 2020-07-10
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Covid-19 outbreak and lockdown measures raised significant concerns over clinical management of chronic pain patients around the world. Patients with chronic musculoskeletal pain (CMSP) are at high risk of physical disability, psychological distress, and poor quality of life. Analgesic medications were main management during lockdown, but opioid-related concerns have prompted to find immediate alternatives.

Present study was undertaken to determine whether patients randomized to tele-yoga therapy would experience less pain, disability and improved global health, adherence and satisfaction, compared with patients assigned to usual care.


Eligibility criteria: Inclusion Criteria:

* Patients having pain that was musculoskeletal, defined as regional (joints, limbs, back, neck) or more generalized (fibromyalgia or chronic widespread pain);
* Persistent pain ( ≥3 months) despite trying conventional treatment.
* Access to virtual platform with internet.
* Ready to give informed consent

Exclusion Criteria:

* Schizophrenia,
* Psychiatric disorder
* Cognitive impairment
* Suicidal ideation
* Current illicit drug use
* Terminal illness

Primary outcomes:
measure: Severity of pain
timeFrame: From baseline to 6-week post intervention
measure: Interference of pain
timeFrame: From baseline to 6-week post intervention
Secondary outcomes:
measure: Global rating of change in pain
timeFrame: From baseline to 6-week post interventiona
measure: Intervention specific satisfaction
timeFrame: From baseline to 6-week post interventiona
Other outcomes:
Locations:
city: Jaipur
country: India
facility: NMP Medical Research Institute
state: Rajasthan
Study officials:
affiliation: NMP Medical Research Institute, India
name: Naveen Meghwal
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarogyam UK
name: Neha Sharma
role: STUDY_DIRECTOR
affiliation: Aarogyam UK
name: Bhavna Pandya
role: STUDY_CHAIR
affiliation: Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University
name: Abhimanyu Kumar
role: STUDY_CHAIR
References:
Clinical trial NCT00954005: Study With Rituximab-Gemcitabine/Oxaliplatin in Relapsed Indolent Lymphoma
Official title: Multicentric Phase I/II Study for the Efficacy of a Combination of Rituximab, Gemcitabine and Oxaliplatin in Relapsed/Refractory Indolent Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Indolent Lymphoma
Keywords: relapsed indolent lymphoma
gemcitabine
oxaliplatin
rituximab
Lead sponsor: German Low Grade Lymphoma Study Group
Sponsor class: OTHER
First posted: 2009-08-06
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the phase I part is to determine the tolerability, the initial safety profile and maximum tolerated dose of oxaliplatin in combination with gemcitabine for indolent lymphoma. In the phase II part the investigators want to estimate the activity of gemcitabine and oxaliplatin in combination with rituximab for patients with relapsed/refractory indolent lymphoma.


Eligibility criteria: Inclusion Criteria:

* Need for therapy in patients with relapsed/refractory patients
* Histological proven diagnosis of an indolent B-cell lymphoma according to the World Health Organization (WHO) classification belonging to one of the following entities:

  * follicular lymphoma
  * mantle cell lymphoma
  * lymphoplasmacytic lymphoma
  * nodal or splenic marginal zone lymphoma
  * measurable disease
  * lymphoma specific therapy in the last four weeks
  * WHO performance grade 0, 1 or 2

Exclusion Criteria

* Patients suitable for high dose therapy
* Transformation in high grade lymphoma
* Leukocytes \< 1,5/nl or platelets \< 100/nl (except due to lymphoma)

Primary outcomes:
measure: Overall Remission Rate
timeFrame: end of therapy
Secondary outcomes:
measure: Progression Free Survival
timeFrame: 5 years
measure: Median Overall Survival
timeFrame: 5 years
measure: Toxicity
timeFrame: 5 years
Other outcomes:
Locations:
city: Ludwigshafen
country: Germany
facility: Klinikum Ludwigshafen
Study officials:
affiliation: German Low Grade Lymphoma Study Group
name: Martin Hoffmann, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06046898: Surface Mechanomyography Using a Parasternal Patch to Measure and Detect Respiratory Drive and Effort
Official title: Performance of Surface Mechanomyography Using a Parasternal Patch to Measure and Detect Respiratory Drive and Effort in Healthy Volunteers - PATCH-MMG
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Failure
Keywords: Acute respiratory failure
Surface mechanomyography
Respiratory effort
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2023-09-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: CROSSOVER
Intervention model description: Esophageal pressure, electrical activity of the diaphram (Eadi) and sMMG will be recorded in 10 healthy subjects in spontaneous ventilation (SV) and non-invasive ventilation with or without resistance.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Surface mechanomyography (sMMG) has been proposed as a tool to study muscle mechanical activity. sMMG is a noninvasive technique using specific transducers to record muscle surface oscillations due to mechanical activity of the motor units . It could be of major interest for the detection of respiratory efforts in patients with respiratory failure. This study aims at assessing the performances of sMMG to measure and detect respiratory drive and effort in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* healthy volunteer
* Age \> 18 and \< 60
* Informed consent
* Fasting
* Subjects covered by or having the rights to medical care assurance

Exclusion Criteria:

* Obesity (BMI \> 30 kg.m-2)
* Respiratory disease
* Cardiovascular disease
* Contraindication to the insertion of a nasogastric tube
* Incapacity to consent
* Pregnancy, breastfeeding
* Bad understanding of the French language,
* Other protected person according to articles L1121.7 and L1121.8 of the French Public Health Act.

Primary outcomes:
measure: Accuracy of sMMG to detect respiratory effort
timeFrame: 5 minutes after the beginning of recording
Secondary outcomes:
measure: Comparison between sMMG-time (MMG-TP) and PTPes-Pes Peak
timeFrame: 5 minutes after the beginning of recording
measure: Comparison between sMMG slope & Eadi parameters
timeFrame: 5 minutes after the beginning of recording
measure: Comparison between sMMG slope & slope Peso
timeFrame: 5 minutes after the beginning of recording
measure: Delay between neural time measured by sMMG and neural time measured by Eadi
timeFrame: 5 minutes after the beginning of recording
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital
Study officials:
References:
Clinical trial NCT01047098: Effects of Taking Prenatal Vitamin-mineral Supplements During Lactation on Iron Status and Markers of Oxidation
Official title: Effects of Taking Prenatal Vitamin-mineral Supplements During Lactation on Iron Status and Markers of Oxidation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Overload
Oxidative Stress
Iron-deficiency Anemia
Keywords: Lactation
Breastfeeding
Iron
Oxidative stress
Iron status and oxidative stress during lactation
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2010-01-12
Enrollment: 114
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Most breastfeeding women are told by their health care provider to continue taking prenatal vitamins after they give birth. A woman's requirement for iron while breastfeeding is low, yet prenatal vitamins contain a large amount of iron. The purpose of this study is to see if breastfeeding women are getting too much iron when taking prenatal vitamins.

Detailed description: Even though iron requirements are much lower for lactating women than for pregnant or non-pregnant, non-lactating women, and iron stores during lactation are often high due to release of iron from the additional maternal erythrocytes produced during pregnancy, iron supplements are often taken by lactating women in the U.S. Many studies have shown that higher iron status is associated with higher risk of certain chronic diseases (e.g. cancer and cardiovascular diseases). The overall goal of this proposed study is to understand the potential for oxidative stress due to iron supplementation, and possible mechanisms for these effects, and to identify safe and efficacious ways to ensure adequate iron status during lactation. The specific aims are:

1. To compare markers of lipid oxidation (urinary isoprostane) and DNA damage (urinary 8-OHdG (urinary 8-hydroxy-2'-deoxyguanosine)) among 3 treatment groups: (iron given between meals (27 mg daily, in a multivitamin-mineral supplement), iron given with meals (27 mg daily, in a multivitamin-mineral supplement) and multivitamin-mineral supplement with no iron, given between meals) at the beginning and end of 3 months of treatment in 114 lactating women.
2. To compare hemoglobin and iron status (ferritin, transferrin saturation, and hepcidin) before and after treatment among the three treatment groups described above.

Eligibility criteria: Inclusion Criteria:

* Women less than 4 weeks postpartum
* 18 years of age or older
* Took prenatal vitamins for at least 3 months during pregnancy
* Successfully initiated breastfeeding

Exclusion Criteria:

* Anemic (Hgb \< 110 g/L)

Primary outcomes:
measure: Oxidative stress
timeFrame: 3 month
measure: Iron status
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
Study officials:
affiliation: Professor
name: Kathryn G Dewey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03411798: Sequential Application of Yisaipu® and DMARDs in Treating Mild-to-Moderate AS
Official title: Sequential Application of Yisaipu® and Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Treating Mild-to-Moderate Ankylosing Spondylitis: the Mid-term Follow-up Result
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ankylosing Spondylitis
Keywords: ankylosing spondylitis(AS)
TNFi
Yisaipu®
Disease modifying anti-rheumatic drugs (DMARDs)
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2018-01-26
Enrollment: 76
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Intervention model description: Yisaipu® was introduced only during the active state and was switched to DMARDs, methotrexate(MTX), sulfasalazine(SSZ) and hydroxychloroquine(HCQ), after disease remission (ESR \& CRP reduce to normal and BASDAI\<4) maintenance.
Primary purpose: TREATMENT

Brief summary: The drug regimes in treating ankylosing spondylitis(AS) have limitations. The tumor necrosis factor inhibitors(TNFi) was effective but expensive. Disease modifying anti-rheumatic drugs (DMARDs) were cheap but insufficient. This study proposed a sequential usage of TNFi, the Yisaipu®, and DMARDs, and aims to evaluate the mid-term therapeutic effect of this new scheme in treating the mild-to-moderate AS.


Eligibility criteria: Inclusion Criteria:

* 1.Clinical diagnosis of Ankylosing Spondylitis(AS) based on modified New York diagnostic criteria for AS (1984) 2.At the mild-to-moderate stage of AS disease 3.At the active phase of AS disease

Exclusion Criteria:

* 1.Active tuberculosis, hepatitis, tumors, infection diseases or combine with other rheumaimmune systemic diseases or osteoarthritis diseases 2.Pregnant or breastfeeding women

Primary outcomes:
measure: ASAS 20
timeFrame: 3 months after
measure: ASAS 20
timeFrame: 6 months after
measure: ASAS 20
timeFrame: 12 months after
measure: ASAS 40
timeFrame: 3 months after
measure: ASAS 40
timeFrame: 6 months after
measure: ASAS 40
timeFrame: 12 months after
Secondary outcomes:
measure: BASDAI
timeFrame: baseline,3 months after,6 months after,12 months after
measure: BASFI
timeFrame: baseline,3 months after,6 months after,12 months after
measure: Patient Global Assessment
timeFrame: baseline,3 months after,6 months after,12 months after
measure: CRP
timeFrame: baseline,3 months after,6 months after,12 months after
measure: ESR
timeFrame: baseline,3 months after,6 months after,12 months after
measure: SQOL-AS
timeFrame: baseline,3 months after,6 months after,12 months after
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT00436098: Pediatric Exercise With Congenital Heart Defects (Kinderturnen Mit Angeborenem Herzfehler)
Official title: Pediatric Exercise With Congenital Heart Defects (Kinderturnen Mit Angeborenem Herzfehler)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Defects, Congenital
Keywords: congenital heart disease
exercise training
motorpedagogical exercise
children
CHD: hemodynamically not significant defects
CHD: acyanotic defects after repair
CHD: cyanotic defects after repair
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
Collaborators: name: Lehrstuhl für Präventive und Rehabilitative Sportmedizin der TU Muenchen
name: Kuratorium für Prävention und Rehabilitation an der TU Muenchen
First posted: 2007-02-16
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Children with congenital heart defects have shown to develop motor coordinative deficiencies. In this study we want to show that a motor pedagogic physical training can improve the coordinative capabilities of children aged 4-6 years.

Detailed description: The study will be performed with a randomized crossover design. After the first assessment of coordinative capabilities children were randomized into two groups. One starts with exercised training for three months. After midterm assessment of the capabilities they will pause for another 3 months and reassessed. The second group will start without training for the first three months. After midterm assessment they will train for three months and have their final assessment.

Eligibility criteria: Inclusion Criteria:

* without significant residuals hemodynamically not significant
* without significant residuals after repair
* age 4-6 incl.

Exclusion Criteria:

* gradient at coarctation site \> 20 mmHg
* gradient RVOT, PV, LVOT, or AoV \> 30 mmHg
* right-left shunt (rest or exercise)
* left-right shunt with dilatation or failure of ana cardiac chamber
* pulmonary hypertension
* heart failure, necessitating therapy
* (suspected) myocarditis or cardiomyopathy
* significant arrhythmia
* ion channel defects, other arrhythmic diseases
* Fontan-like circulation
* repair by atrial switch
* oral anticoagulation
* other medical problems curtailing exercise capacity

Primary outcomes:
measure: Activity: triaxial accelerometry
timeFrame: 3 months
Secondary outcomes:
measure: coordinative test: MOT 4-6
timeFrame: 3 months
measure: coordinative test: LOS KF 18
timeFrame: 3 months
measure: Quality of life: Kiddy-KINDL
timeFrame: 3 months
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Deutsches Herzzentrum Muenchen
city: Munich
country: Germany
facility: Kuratorium für Prävention und Rehabilitation der TU München
Study officials:
affiliation: Deutsches Herzzentrum München
name: Alfred Hager, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02742298: Pompe Disease QMUS and EIM
Official title: Electrical Impedance Myography and Muscle Ultrasound: Longitudinal Measures in Pompe Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pompe Disease
Keywords: Neuromuscular Ultrasound
Electrical Impedance Myography
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Genzyme, a Sanofi Company
First posted: 2016-04-19
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Study Objectives:

1. Determine the correlation between quantitative muscle ultrasound (QMUS), electrical impedance myography (EIM) and currently accepted measures of physical function.
2. Determine the reliability of EIM measures performed in the home through use of a hand held device.
3. Determine if QMUS and EIM can detect pre-clinical changes in Pompe disease.


Eligibility criteria: Inclusion Criteria:

* Genetically confirmed diagnosis of Pompe disease.

Exclusion Criteria:

* Age \<18 years
* Inability to provide informed consent.

Primary outcomes:
measure: Percent change in muscle ultrasound echointensity as compared to baseline
timeFrame: Baseline, 1-2 years
measure: Percent change in muscle electrical impedance myography as compared to baseline
timeFrame: Baseline, 1-2 years
Secondary outcomes:
measure: Inter-rater reliability of muscle ultrasound and electrical impedance myography measures
timeFrame: 1-2 years
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Lisa D Hobson-Webb, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04633798: Evaluation of the Efficacy of Intense Pulse Light Combined With Lipiflow in the Treatment of Meibomian Gland Dysfunction
Official title: Evaluation of the Efficacy of Intense Pulse Light Combined With Lipiflow in the Treatment of Meibomian Gland Dysfunction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Meibomian Gland Dysfunction
Lead sponsor: Aier School of Ophthalmology, Central South University
Sponsor class: OTHER
First posted: 2020-11-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effect of IPL combined with lipiflow and IPL combined with meibomian gland massage in treating meibomian gland dysfunction of different degrees ,focusing on effective rate, lasting time and changes of meibomian gland function and morphology.

Detailed description: To divide all participants into two groups, group one treated with IPL combined with Lipiflow and group two treated with IPL combined with meibomian gland massage.The following parameters were recorded after treatment: the effective rate, lasting time and changes of meibomian gland function and morphology.All parameters were compared between the two groups.

Eligibility criteria: Inclusion Criteria:

* patients with meibomian gland dysfunction
* patients with ocular discomfort
* skin type:FitzpatricⅠ-Ⅳ

Exclusion Criteria:

* patients with acute ocular inflammation
* eye surgery history in the last 12 months
* patients who have received IPL or Lipiflow in the last 12 months
* patients who wear contact lens in last one month

Primary outcomes:
measure: ocular surface disease index(OSDI)
timeFrame: 6 months
measure: meibomian gland expressibility score and meibum quality score
timeFrame: 6 months
measure: meibomian gland dropout score
timeFrame: 6 months
measure: Breakup time
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai aier eys hospital
name: Yan Chen, doctor
role: PRINCIPAL_INVESTIGATOR
References: