louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01399957: Responsiveness to Dalfampridine-ER Treatment Among Multiple Sclerosis Patients
Official title: Responsiveness to Dalfampridine Treatment Among Multiple Sclerosis Patients Followed at the Mandell MS Center: Characterizing Clinical Predictors of Response and Identifying Additional Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Dalfampridine-ER
Walking speed
Lead sponsor: Mount Sinai Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: Brown University
name: Acorda Therapeutics
First posted: 2011-07-22
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons with MS who have been prescribed ampyra at the Mandell Center for Multiple Sclerosis.

Brief summary: Ampyra (dalfampridine-ER) was approved by the FDA (2010) for improving walking speed in persons with multiple sclerosis. This project seeks to determine if there are other benefits to taking dalfampridine besides an increase in walking speed. This is strictly an observational study and research staff will not be involved in any decisions to stop or start taking the medication.

Detailed description: Subjects will be evaluated before starting medication, throughout a 14week period after starting D-ER as well as at 12 and 18months following the start date of medication regardless of if they stayed on medication or not.

Eligibility criteria: Inclusion Criteria:

* Confirmed clinical diagnosis of MS by McDonald criteria
* Prescribed ampyra (dalfampridine) as part of usual care, but have not yet started taking the medication before baseline visit
* Receive MS care at the Mandell MS center
* Cognitively able to understand directions and complete protocol (score of 22 or greater on the MMSE)
* 18 years of age or older

Exclusion Criteria:

* Already began to take drug prior to baseline research visit
* Not planning to continue care at Mandell Center for at least 14 weeks after initiation of therapy
* Unwilling or unable to complete assessments

Primary outcomes:
measure: Change in 25ft walk time
timeFrame: Baseline (pre drug) and followup at 3.5 weeks, 7 weeks, 10.5 weeks and 14weeks
measure: Change in 6 minute walk distance
timeFrame: Baseline (pre drug) and followup at 3.5 weeks, 7 weeks, 10.5 weeks and 14weeks
Secondary outcomes:
measure: Change of Upper extremity dexterity with 9hole peg test
timeFrame: Baseline (pre drug) and followup at 3.5 weeks, 7 weeks, 10.5 weeks and 14weeks
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Mandell Center for Multiple Sclerosis at the Mount Sinai Rehabilitation Hospital
state: Connecticut
Study officials:
affiliation: Mandell Center for Multiple Sclerosis at Mount Sinai Rehabilitation Hospital
name: Albert Lo, M.D, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Brown University
name: Elizabeth Triche, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04773457: Neutrophil Phenotypic Profiling and Surgical Site Infections in Surgical Patients
Official title: Neutrophil Phenotypic Profiling and Surgical Site Infections in Surgical Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Surgical Site Infection
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 220
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients presenting for elective surgical procedures (open gastrointestinal surgery or spine fusion surgery) at Boston Children's Hospital.

Brief summary: Surgical site infections (SSIs) are one of the major hospital acquired infections and responsible for the most cost among the hospital acquired infections. The objective of this study is to assess the neutrophil functional profiles and their associations with SSIs.


Eligibility criteria: Inclusion Criteria:

* scheduled for an elective open gastrointestinal surgical procedure or spine fusion surgery

Exclusion Criteria:

* On chronic immunosuppressive drugs such as chronic corticosteroid use
* preexisting immunodeficiency diseases

Primary outcomes:
measure: Neutrophil populations
timeFrame: up to 3 days
measure: Neutrophil functional impairment
timeFrame: up to 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hopsital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Koichi Yuki, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01108757: Prevention of Catheter-Associated Urinary Tract Infection in Incontinence and Reconstructive Pelvic Surgery Patients
Official title: Prevention of Catheter-Associated Urinary Tract Infections in Patients Undergoing Incontinence and Reconstructive Pelvic Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Catheter-Associated Urinary Tract Infection
Keywords: catheter
urinary tract infection
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: American Urogynecologic Society
First posted: 2010-04-22
Enrollment: 52
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study will assess the risk of catheter associated urinary tract infection in women undergoing incontinence or reconstructive pelvic surgery. Women will be given an antibiotic or placebo at the time of catheter removal. The investigators hypothesize that prophylactic antibiotics will reduce the rate of infection.


Eligibility criteria: Inclusion Criteria:

* Requires catheterization \>24h hours following incontinence or pelvic reconstructive surgery

Exclusion Criteria:

* Receipt of antibiotics for either prophylaxis or treatment of a known infection during the postoperative hospitalization
* Allergy to sulfonamides or trimethoprim
* Non-English speaking
* Pregnancy
* Breast feeding
* Severe renal impairment (creatinine clearance \<30)
* Patients taking dofetilide, methenamine, procaine, warfarin, procainamide, methotrexate.

Primary outcomes:
measure: Number of Participants With Urinary Tract Infection
timeFrame: 7 days following catheter removal
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Matthew D Barber, MD MHS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03910257: Nutrition Education Module for Preschooler Children
Official title: the Effectiveness of Nutrition Education Module to Knowledge of Preschooler Children in Public Kindergarten at 3 Districts of Riau Province
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children Who Registered on the Selected Public Kindergarten and Agree to Follow the Study Assigned by Their Parents and Teacher
Lead sponsor: SEAMEO Regional Centre for Food and Nutrition
Sponsor class: OTHER
First posted: 2019-04-10
Enrollment: 300
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a quasi-experimental research design with pre-and post-test control group design
Primary purpose: OTHER

Brief summary: This study evaluates the knowledge of preschooler children before and after intervention of nutrition education using nutrition education module for preschooler children. The teachers will be given training regarding the module and deliver it in the class during the intervention.

Detailed description: A nutrition education module for preschooler children had been developed in the previous study. The module consists of 3 topics of nutrition (my meal plate, fruits and vegetables, healthy snacks). Each topic consists of 4 activities engaging children and teachers. A total of 12 activities will be delivered on 4 consecutive school day every week.

The teacher will deliver the nutrition education which trained prior to the study.

Eligibility criteria: Inclusion Criteria:

* children registered in selected public kindergarten
* grade/class B kindergarten
* willing to follow the study

Exclusion Criteria:

-

Primary outcomes:
measure: Changes on nutrition related knowledge before and after intevention
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Pekanbaru
country: Indonesia
facility: TK Negeri Pembina Pekanbaru
state: Riau
Study officials:
References:
Clinical trial NCT05193357: Home-based Intermittent Pneumatic Compression Therapy for Gynecologic Cancer
Official title: Home-based Intermittent Pneumatic Compression Therapy: the Impact in Chronic Leg Lymphedema in Patients Treated for Gynecologic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Cancer
Lymphedema of Leg
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Republic of Korea
First posted: 2022-01-14
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Investigators conducted a prospective study of cancer patients to investigate the efficacy, quality of life, satisfaction, and safety of a home-based intermittent pneumatic compression (IPC) device during the maintenance phase of lower extremity lymphedema. This device has a unique mode designed to mimic the manual lymphatic drainage (MLD) technique and thereby gently facilitate lymphatic draining of proximal extremities.


Eligibility criteria: Inclusion Criteria:

* stage 3 chronic unilateral secondary leg lymphedema
* aged 20-70 years
* underwent 1-2 cycle of treatment of decongestive phase with current inter-limb volume difference of more than 10%
* stable limb-volume change (within 10%) during the preceding 3 months
* capacity for self-maintenance care for lymphedema (multilayer limb bandaging, compression garments, and MLD)

Exclusion Criteria:

* bilateral leg lymphedema
* current cancer metastasis
* ongoing chemotherapy or radiation therapy
* acute inflammation
* venous thrombosis, or chronic venous insufficiency
* systemic etiologies of edema
* congestive heart failure
* patients taking medication that influenced body fluid or electrolytes

Primary outcomes:
measure: Change of Inter-limb volume difference ratio
timeFrame: Baseline, after 1 month (4-week)
Secondary outcomes:
measure: Change of Quality of life (Lymph-ICF-LL)
timeFrame: Baseline, after 1 month (4-week)
measure: Participant satisfaction questionnaire
timeFrame: after 1 month (4-week)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT03067857: Autologous Bone Marrow-Derived Stem Cell Therapy for Motor Neuron Disease
Official title: Autologous Purified Bone-Marrow-Derived Stem Cell Therapy for Motor Neuron Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Primary Lateral Sclerosis
Progressive Muscular Atrophy
Progressive Bulbar Palsies
Lead sponsor: Stem Cells Arabia
Sponsor class: OTHER
First posted: 2017-03-01
Enrollment: 40
Sex: ALL
Minimum age (years): 24
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Herein, the investigators study the safety and efficacy of transplanting purified autologous bone marrow-derived stem cells transplanted via the intrathecal route by interventional radiology and the intravenous route.

Detailed description: A motor neuron disease (MND) is any of several neurological disorders that selectively affect motor neurons, the cells that control voluntary muscles of the body. They include amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS), progressive muscular atrophy (PMA), progressive bulbar palsy (PBP) and pseudobulbar palsy; spinal muscular atrophies are also sometimes included in the group.They are neurodegenerative diseases that cause increasing disability and eventually, death.

In spite of intensive research, motor neuron diseases (MNDs) are still incurable. Some of the key factors in this failure to find a cure have been the lack of human cell-based disease models for molecular analysis and drug screening and the difficulty of obtaining homogeneous populations of specific cell types for clinical applications. Stem cell biology has the potential to transform our understanding of disease processes and to revolutionize our approach to develop novel therapies for MNDs.

In this study, the investigators suggest a protocol for the treatment of MND by transplantation of purified autologous bone marrow-derived stem cells via the intrathecal and intravenous route.

Eligibility criteria: Inclusion Criteria:

* Patients age 24-20 years old
* Patients with the diagnosis of definite Motor Neuron Disease

Exclusion Criteria:

* HIV/HBV/HCV
* Malignancies
* Bleeding
* Pneumonia
* Renal failure
* liver dysfunction
* Severe anemia (hb \< 8)
* Bone Marrow diseases
* Pregnancy and lactation
* Acute medical conditions/infections such as respiratory infections
* ventilatory support

Primary outcomes:
measure: Changes in Functional Rating Scale - via questionnaire
timeFrame: 6 months
Secondary outcomes:
measure: Change in Appel Scale
timeFrame: 4 months
measure: Change in SF-36 (The Short Form (36) Health Survey is a 36 Item)
timeFrame: 4 months
measure: Change in Forced Vital Capacity (FVC)
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02818257: An Investigation Exploring Adhesive Materials and Their Ability to Handle Moisture
Official title: An Investigation Exploring Adhesive Materials and Their Ability to Handle Moisture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2016-06-29
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aim is to investigate the impact that water absorption properties in adhesives has on adhesion.


Eligibility criteria: Inclusion Criteria:

* Have given written informed consent
* Be at least 18 years of age and have full legal capacity
* Have intact skin on the area used in the investigation

Exclusion Criteria:

* Currently receiving or have within the past 2 month received radio- and/or chemotherapy
* Currently receiving or have within the past month received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment.
* Are pregnant or breastfeeding
* Having dermatological problems in the abdominal area (assessed by investigator)
* Participate in other clinical investigations or have previously participated in this investigation

Primary outcomes:
measure: Peel force used to removed adhesive
timeFrame: 60 min
Secondary outcomes:
Other outcomes:
Locations:
city: Humlebæk
country: Denmark
facility: Coloplast
Study officials:
References:
Clinical trial NCT01414257: Methotrexate (Rheumatrex) High Dose Special Investigation (Regulatory Post Marketing Commitment Plan)
Official title: Rheumatrex High Dose Special Investigation (Regulatory Post Marketing Commitment Plan)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis
Rheumatoid
High Dose
Keywords: Rheumatrex
High Dose
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-08-11
Enrollment: 2860
Sex: ALL
Minimum age (years): 17
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who receive the MTX Preparation at the dose higher than 8 mg/week for the treatment of Rheumatoid Arthritis.

Brief summary: This Investigation is to be performed for the purpose of assessing the following information in the long-term post-marketing daily medical practice in the patients who receive REUMATOLEX 2 mg Capsule for the treatment of Rheumatoid Arthritis (RA) at the dose higher than 8 mg/week.

1. Condition of occurrence of ADRs
2. Factors considered to affect safety
3. Verification of efficacy

Detailed description: Implemented as a Special Investigation by Central Registration System

Eligibility criteria: Inclusion Criteria:

* Patients need to be administered Rheumatrex in order to be enrolled in the survey
* Patients who receive the Rheumatrex at the dose higher than 8 mg/week for the treatment of Rheumatoid Arthritis

Exclusion Criteria:

* Patients who have been treated with Rheumatrex at the dose higher than 8 mg/week since the days when the high dose therapy for RA was not approved
* Patients who have been treated MTX other than Rheumatrex administered Rheumatrex

Primary outcomes:
measure: Number of Participants With Treatment-Related Adverse Events
timeFrame: 24 Weeks
measure: Disease Activity Score (DAS28)-4ESR
timeFrame: Baseline and 24 Weeks
measure: Disease Activity Score (DAS28)-4CRP
timeFrame: Baseline and 24 Weeks
measure: Change From Baseline in Disease Activity Score (DAS28)-4ESR
timeFrame: Baseline and 24 Weeks
measure: Change From Baseline in Disease Activity Score (DAS28)-4CRP
timeFrame: Baseline and 24 Weeks
Secondary outcomes:
measure: Number of Participants With Treatment-Related Serious Adverse Events
timeFrame: 24 Weeks
measure: Number of Participants With Treatment Related Pre-specified Important Serious Adverse Events
timeFrame: 24 Weeks
measure: Clinical Efficacy Rate
timeFrame: 24 Weeks
Other outcomes:
Locations:
city: Kitakyushu-shi
country: Japan
facility: University of Occupational and Environmental Health Hospital
state: Fukuoka-ken
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06900257: Fetal Cardiac Functions in Fasting Pregnant Women
Official title: Evaluation of Fetal Cardiac Functions in Fasting Pregnant Women
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Fasting Pregnant Women
Keywords: Fasting
Pregnancy
Fetal echocardiography
Fetal health
Lead sponsor: Sanliurfa Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2025-03-28
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Singleton uncomplicated pregnancies that present for routine antenatal follow-up between 24-34 weeks of gestation.

Brief summary: In this study, we aimed to evaluate fetal cardiac functions after a fasting period of at least 10 days. The purpose of this study was to determine the unexpected effects of fasting on fetal cardiac functions.

Detailed description: Pregnancies at 24-34 weeks of gestation who present to our hospital for routine antenatal follow-up will be evaluated. As the study group, singleton uncomplicated pregnancies with at least 10 days of fasting will be assessed. All ultrasonographic examinations will be conducted within the last 2 hours of the fasting period. The control group will consist of healthy pregnant women who do not fast, with singleton uncomplicated pregnancies between 24-34 weeks, matched for age, parity, and gestational age.

Eligibility criteria: Inclusion Criteria:

* Singleton, uncomplicated pregnancies that have been fasting for at least the last 10 days
* Present for routine antenatal follow-up between 24-34 weeks of gestation

Exclusion Criteria:

* Multiple pregnancy
* Premature rupture of membranes
* Chorioamnionitis
* Placental abruption
* Severe fetal growth restriction
* Congenital fetal anomalies
* Preeclampsia
* Oligohydramnios
* Maternal diabetes -Conditions where fasting is contraindicated for the mother. -

Primary outcomes:
measure: Singleton uncomplicated pregnancies with at least 10 days of fasting.
timeFrame: Fetal echocardiographic findings after at least 10 days of fasting.
Secondary outcomes:
Other outcomes:
Locations:
city: Şanlıurfa
country: Turkey
facility: Sanliurfa Education and Research Hospital
Study officials:
References:
Clinical trial NCT02757157: Comparison of Walking in Water and on Land in People With Chronic Obstructive Pulmonary Disease (COPD)
Official title: Determining the Metabolic Load of Walking in Water Compared to Walking on Land in People With COPD, Who Are Normal Weight and Obese, Compared to Peak Exercise Metabolic Response: a Prospective, Randomised Cross-over Pilot Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Hydrotherapy
Walking
Lead sponsor: European Respiratory Society
Sponsor class: OTHER
Collaborators: name: Center for Integrated Rehabilitation and Organ Failure Horn
First posted: 2016-04-29
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the metabolic load during a single session of moderate intensity walking in water compared to walking on land (over-ground) in people with chronic obstructive pulmonary disease (COPD) who are normal weight and obese, compared with peak exercise metabolic response.

The hypothesis is that the metabolic load of walking at a moderate intensity in water will be greater than walking on land.


Eligibility criteria: Inclusion Criteria:

* diagnosis of COPD (FEV1/FVC \<0.7) in a clinically stable state (no acute exacerbation of COPD within the previous 4 weeks)
* accepting of walking in water
* BMI \>/= 21 kg/m2

Exclusion Criteria:

* long-term oxygen therapy
* contraindications to entering a hydrotherapy pool

Primary outcomes:
measure: Breath-by-breath oxygen consumption (VO2)
timeFrame: Day of assessment during study measurement period (15 minutes)
Secondary outcomes:
measure: Minute ventilation (VE)
timeFrame: Day of assessment during study measurement period (15 minutes)
Other outcomes:
measure: Dyspnoea, measured by the modified Borg 0-10 category ratio scale
timeFrame: Day of assessment during study measurement period (15 minutes)
measure: Exertion, measured by the modified Borg 0-10 category ratio scale
timeFrame: Day of assessment during study measurement period (15 minutes)
measure: Oxygen saturation
timeFrame: Day of assessment during study measurement period (15 minutes)
measure: Heart rate
timeFrame: Day of assessment during study measurement period (15 minutes)
Locations:
city: Horn
country: Netherlands
facility: Centre of intergrated rehabilitation for chronic organ failure
Study officials:
affiliation: Centre of integrated rehabilitation for chronic organ failure
name: Martijn A Spruit, PhD
role: STUDY_DIRECTOR
References: