louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01911559: Effectiveness of Standing Frame on Constipation in Children With Cerebral Palsy
Official title: Effectiveness of Standing Frame on Constipation in Children With Cerebral Palsy: a Single Subject Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Quadriplegia
Diplegia
Constipation
Keywords: Standing-frame
Chronic constipation
Cerebral palsy
Quadriplegia
Severe diplegia
Lead sponsor: University of Modena and Reggio Emilia
Sponsor class: OTHER
Collaborators: name: Azienda Unita' Sanitaria Locale Di Modena
First posted: 2013-07-30
Enrollment: 1
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this study we included children with CP, in the manifestation of severe diplegia or quadriplegia, who do not currently use the standing-frame. The population of interest might be referred to the Unit for severe disability in developmental age or to one of the neuro-psychiatric and rehabilitation Units of the area of Modena and Reggio Emilia, (5.000 km2 of surface and 1.250.000 inhabitants)

Brief summary: Children with Cerebral Palsy and quadriplegia or severe diplegia suffer from highly reduced mobility and consequent constipation. Clinicians frequently recommend standing-frames to exercise the support reaction in this population, sharing the opinion that the upright position may facilitate intestinal transit, although no evidence supports this assumption.

The investigators conducted this single-subject research to determine the effects of the standing-frame on the frequency of evacuation in chronically constipated children with CP and quadriplegia.

Moreover, the investigators studied its effects on the frequency of induction of evacuation, the characteristics of the stool and the pain suffered by the child due to constipation and/or evacuation.


Eligibility criteria: Inclusion criteria were:

* clinical indication for the use of the standing-frame;
* constipation problems as defined by guidelines (Clinical Practice Guideline, 2006);
* whose parents gave the informed consent to let their child to participate in this study.

Exclusion criteria were:

* children who have orthosympathetic reactions to the upright position, skeletal deformities and/or medical conditions that, according to clinical judgment, advise against the use of the standing frame.

Primary outcomes:
measure: bowel evacuation frequency
timeFrame: 14 weeks
Secondary outcomes:
measure: Bowel evacuation inductions frequency
timeFrame: 14 weeks
Other outcomes:
measure: pain related to the bowel evacuation
timeFrame: 14 weeks
measure: distress of the caregiver
timeFrame: 14 weeks
Locations:
city: Carpi
country: Italy
facility: Local Health Institution of Modena
state: Modena
Study officials:
References:
citation: Pin TW. Effectiveness of static weight-bearing exercises in children with cerebral palsy. Pediatr Phys Ther. 2007 Spring;19(1):62-73. doi: 10.1097/PEP.0b013e3180302111.
Clinical trial NCT05581459: Muscle Vibration and Joint Position Sense
Official title: Acute Effects of Muscle Vibration on the Elbow Joint Position Sense in Healthy Young Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vibration; Exposure
Keywords: Muscle vibration
joint position sense
proprioception
elbow
rehabilitation
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 45
Sex: MALE
Minimum age (years): 19
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The present study aimed to investigate and compare the acute effect of local vibration (63 Hz vs 42 Hz frequencies) on the biceps brachii muscles on the elbow joint position sense (JPS) in healthy young men. Forty-five healthy young men aged 19 to 30 years were enrolled in the study. The participants were randomly assigned to receive either 63 Hz (n=15) or 42 Hz (n=15) or sham vibration (control group) (n=15). Participants in the experimental group received five bouts of 1-minute of each vibration exposure localized to the biceps brachii muscle, with a 1-minute rest between the bouts. Active elbow joint position error (in degrees) was selected as an outcome measure to assess elbow JPS. To measure active elbow joint position error, the subject was made to sit on the chair with eyes closed and shoulders in 0 degree of abduction and elbows fully extended. The examiner passively moved the elbow to 90 degrees of flexion (target position) and maintained it for 10 seconds. The subject was requested to memorize the target position. The subject was asked to actively flex the elbow to the target position from the initial starting position (elbow fully extended) and hold it for 5 seconds. Three trials were conducted, with a 30-second rest given between each trial. The target and reproduced angles in each trial were measured using a standard plastic goniometer. The difference between the target and reproduced angles in each trial was calculated to determine active elbow joint position error. Measurements were taken at baseline and immediately after the vibration protocol.


Eligibility criteria: Inclusion Criteria:

* Healthy young men

Exclusion Criteria:

* history of recent upper extremity surgery
* history of sensory deficits in the upper extremity
* recent upper extremity injury
* undergoing any resistance training

Primary outcomes:
measure: Active elbow joint position error
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Saud University
Study officials:
affiliation: King Saud University
name: Masood Khan, M.P.Th
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06668259: Intensive Longitudinal Assessment of Stress and Stress-related Concepts Across a Behavioral Weight Loss Intervention
Official title: Intensive Longitudinal Assessment of Stress and Stress-related Concepts Across a Behavioral Weight Loss Intervention: INSTANT Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Individual Stress and Weight Loss
Keywords: stress
weight loss
EMA
weight gain
cortisol
surveys
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2024-10-31
Enrollment: 100
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: Individuals who are enrolled in a KUMC community-based weight loss program centered in a metropolitan area of a Midwest state will be eligible to participate

Brief summary: Examine the association between variability in individual stress and related concepts with weight loss, physical activity, and sleep across a behavioral weight loss program


Eligibility criteria: Inclusion Criteria:

* Enrolled in a KUMC community-based weight loss program centered in a metropolitan area of a Midwest state. Based on this criteria, we will anticipate participants are greater than 18 years of age, and have obesity
* Must own a smart phone and be willing to download the mobile application to receive text messages

Exclusion Criteria:

* Report a current medical condition or treatment for a medical condition that could affect body weight.
* Current psychological condition that is untreated, hospitalization for a psychological condition within the past 12 months, or not being on a stable dose of treatment for at least 6 months.
* Clinically diagnosed depression.
* Is not fluent in writing or speaking the English language.
* Mobility limitations so they are unable to perform physical activity.
* Family member currently enrolled in the study or has a family member that previously participated in the study.

Primary outcomes:
measure: Weight (kg)
timeFrame: 0 Weeks, 6 Weeks, 12 Weeks, and 26 Weeks
measure: Physical Activity
timeFrame: 0 Weeks, 6 Weeks, 12 Weeks, and 26 Weeks
measure: Sleep
timeFrame: 0 Weeks, 6 Weeks, 12 Weeks, and 26 Weeks
measure: Stress-related Concepts (EMA)
timeFrame: 0 Weeks, 6 Weeks, 12 Weeks, and 26 Weeks
Secondary outcomes:
measure: Cortisol (mg/mL)
timeFrame: 0 Weeks, 6 Weeks, 12 Weeks, and 26 Weeks
Other outcomes:
Locations:
city: Fairway
country: United States
facility: Fairway North
state: Kansas
city: Kansas City
country: United States
facility: Kirmayer Fitness Center
state: Kansas
Study officials:
References:
Clinical trial NCT04377659: Tocilizumab for Prevention of Respiratory Failure in Patients With Severe COVID-19 Infection
Official title: A Phase II Study of IL-6 Receptor Antagonist Tocilizumab to Prevent Respiratory Failure and Death in Patients With Severe COVID-19 Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: COVID-19
Keywords: COVD-19
Tocilizumab
Respiratory infection
20-185
Memorial Sloan Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 9
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: The purpose of this study is to find out whether the study drug tocilizumab is an effective treatment for COVID-19 infection.


Eligibility criteria: Inclusion Criteria:

* Patient or designated proxy willing and able to provide informed consent prior to enrollment in the study.
* COVID-19 PCR positive on nasopharyngeal swab
* Aged \>/= 18 years old
* Patient hospitalized with newly diagnosed documented severe COVID-19 infection: with respiratory rate \>/= 30 breaths/min OR peripheral capillary oxygen saturation (SpO2) \< 93% on room air for nonintubated pts.
* Fever of 38.5 C or suspected respiratory infection
* IL-6 level \>/= 80 pcg/ml
* Cohort #1 - non intubated Cohort #2 - intubated
* Women of childbearing potential must have a negative serum or urine pregnancy test
* Patients receiving ongoing steroid therapy are eligible
* Patients will be allowed to receive concurrent or sequential treatment with remdesivir

Exclusion Criteria:

* Patients with uncontrolled systemic fungal and bacterial infections
* Patients with latent tuberculosis
* Patients with known hypersensitivity to tocilizumab or any component of the formulation
* Concurrent initiation of steroid therapy is not allowed
* Patients with uncrontroled malignant disease, with a life expectancy of 3 months or less

Primary outcomes:
measure: Progression of Respiratory Failure or Death
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Boglarka Gyurkocza, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05415059: LEAFix Adhesion in Healthy Volunteers
Official title: Laryngeal, Endotracheal Airway Fixator (LEAFix): In Vivo Skin Adhesion Verification Protocol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adhesion
Lead sponsor: Liverpool University Hospitals NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2022-06-10
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study compares the adhesiveness of the 3M material to be used in the final design.

Detailed description: The material is taken from a CE marked stoma bag. Strips will be placed on to healthy volunteers on the arm and face for 10 minutes and 24 hours. A force gauge will measure the peel force. This will be compared to previous testing on metal.

Participants will also be assessed and followed up for any adverse skin issues.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Not been in a trial in last 12 weeks
* mild to no skin issues

Exclusion Criteria:

* any significant allergies
* any allergies to skin adhesive
* any medium to severe skin issues

Primary outcomes:
measure: Adhesion after 24 hours
timeFrame: 24 hours
Secondary outcomes:
measure: Skin outcomes
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05147259: A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HR011408 at Two Formulations in Healthy Subject
Official title: A Single Center, Randomized, Double-Blind, Single Ascending Dose, Crossover Designed Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HR011408 at Two Formulations in Healthy Subject
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Diabetes in Adults
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-12-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover Assigned to HR011408(formulation A) or HR011408(formulation B)
Primary purpose: TREATMENT

Brief summary: The objective of the study is to assess the safety, tolerability and pharmacokinetics of HR011408 at two formulations in healthy subject.


Eligibility criteria: Inclusion Criteria:

1. Male or female aged 18-55 years(both inclusive) at the time of signing informed consent
2. Body mass index 18.0-26.0kg/m2(both inclusive)
3. Body weight ≥50.0kg(male),≥45.0kg(female)
4. Fasting serum/plasma glucose \<6.1mmol/L

Exclusion Criteria:

1. Known or suspected of being allergic to any ingredient in the study drug.
2. Participated in any drug or medical device-related clinical trial within 3 months before screening.
3. Subjects addicted to smoking, or non-smoker who smoked within 48 hours before administration
4. Donated blood within 1 month before screening; or donated blood ≥400 mL or had blood loss ≥400 mL during trauma or major surgery within 3 months before screening.
5. Subjects with incompetence or language impairment, who cannot fully understand or participate in the study.

Primary outcomes:
measure: Incidence and severity of adverse events (AEs)
timeFrame: from Day1 to Day15
measure: Area under the concentration-time curve (AUC)
timeFrame: from 0 to 10 hours after dose administration
measure: Maximum observed concentration (Cmax)
timeFrame: from 0 to 10 hours after dose administration
measure: Time to maximum observed concentration (Tmax)
timeFrame: from 0 to 10 hours after dose administration
measure: Elimination half-life (t1/2)
timeFrame: from 0 to 10 hours after dose administration
measure: Time to 50% maximum observed concentration (time to 50% Cmax)
timeFrame: from 0 to 10 hours after dose administration
measure: Onset of appearance
timeFrame: from 0 to 10 hours after dose administration
Secondary outcomes:
measure: Assessment of development of Anti-drug Antibodies (ADAs)
timeFrame: from Day1 to Day15 after dose administration
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02179359: Hematopoietic Stem Cell Transplant for High Risk Hemoglobinopathies
Official title: MT2014-10C: Allogeneic Hematopoietic Stem Cell Transplant for Patients With High Risk Hemoglobinopathies and Other Red Cell Transfusion Dependent Disorders
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sickle Cell Disease
Transfusion Dependent Alpha- or Beta- Thalassemia
Diamond Blackfan Anemia
Paroxysmal Nocturnal Hemoglobinuria
Glanzmann Thrombasthenia
Severe Congenital Neutropenia
Shwachman-Diamond Syndrome
Non-Malignant Hematologic Disorders
Keywords: Stem Cell Transplant
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2014-07-01
Enrollment: 38
Sex: ALL
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study to collect the outcomes of stem cell transplantation for patients with hematologic diseases other than cancer.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Sickle Cell Disease, Thalassemia, Diamond Blackfan Anemia or other non-malignant hematologic disorders for which a stem cell transplant is indicated
* Acceptable stem cell source identified
* Performance status of ≥ 70% (Karnofsky),or ≥ 70 (Lansky play score)
* Creatinine \<2.0 mg/dl for adults or glomerular filtration rate \> 50 ml/min for children
* Bilirubin, Aspartate Aminotransferase, Alkaline phosphatase \<5 times the upper limit of institutional normal
* Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction \> 40%

Exclusion Criteria:

* active, uncontrolled infection
* pregnant or breastfeeding
* HIV positive

Primary outcomes:
measure: incidence of graft failure
timeFrame: 42 days
Secondary outcomes:
measure: overall survival
timeFrame: 6 months, 1 and 2 years
measure: disease free survival
timeFrame: 6 months, 1 and 2 years
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center, Fairview
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Ashish Gupta, MBBS, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04212559: Hemodynamic Effects of Negative Pressure Ventilation in Chronic Obstructive Pulmonary Disease
Official title: Hemodynamic Effects of Negative Pressure Ventilation in Chronic Obstructive Pulmonary Disease Assessed Using Non-Invasive Electrical Cardiometry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Lead sponsor: Fu Jen Catholic University
Sponsor class: OTHER
First posted: 2019-12-27
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD

Brief summary: Negative pressure ventilation (NPV) is a non-invasive ventilation mode which provide better lung expansion. The major complication of NPV is decrease blood pressure and affects the hemodynamics. The effects of NPV on chronic obstructive pulmonary disease (COPD) patients with pulmonary rehabilitation program remains unknown.

Detailed description: Both of NPV or positive pressure ventilation (PPV) has impact of hemodynamics. NPV with cuirass ventilator increases venous return and leads to ventricular filling and increases cardiac output (CO); In contrast to NPV, the effect of PPV in most situations is a decreased venous return and leads to decreased CO. NPV improving ventilation and work of breathing in patients with chronic obstructive pulmonary disease (COPD).

Eligibility criteria: Inclusion Criteria:

* Patients with COPD who received pulmonary rehabilitation program with NPV treatment

Exclusion Criteria:

* Recent exacerbation within 3-months
* Existing of tracheostomy
* Absence of NPV used
* Required of oxygen supplement during NPV
* Diagnosed of neuromuscular disease

Primary outcomes:
measure: CO (cardiac output)
timeFrame: 20 minutes
measure: SV (stroke volume)
timeFrame: 20 minutes
Secondary outcomes:
measure: SpO2
timeFrame: 20 minutes
measure: RR (respiratory rate)
timeFrame: 20 minutes
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Fu Jen Catholic University Hospital, Fu Jen Catholic University
Study officials:
References:
Clinical trial NCT05704959: Does Povidone-Iodine on Nail Affect Pulse Oximeter Reading?
Official title: Does Povidone-Iodine on Nail Affect Pulse Oximeter Reading?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HEALTHY INDIVIDUALS
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2023-01-30
Enrollment: 122
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Povidone iodine is still a commonly used antiseptic in hospitals. Although pulse oximetry measurement is used as an important indicator in hospitals, no study has been found examining the effect of povidone iodine on the nail bed on the pulse oximetry result.

Detailed description: Povidone iodine is still a commonly used antiseptic in hospitals. Although pulse oximetry measurement is used as an important indicator in hospitals, no study has been found examining the effect of povidone iodine on the nail bed on the pulse oximetry result. The aim of this study is to determine the effect of 10% povidone iodine on the nail bed on the oxygen saturation reading in pulse oximetry.

Eligibility criteria: Inclusion Criteria:

* Volunteer person
* Healthy person

Exclusion Criteria:

* Patients in hospital
* People with finger loss

Primary outcomes:
measure: The effect of 10% povidone iodine in the nail bed on the SpO2 reading of the pulse oximeter
timeFrame: during the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Hasan Kalyoncu University
Study officials:
References:
Clinical trial NCT04161859: Use of Nutraceuticals in Clinical Practice
Official title: Observational Study on the Use of the Nutraceutical With Cardio-metabolic Actions in the Patient in Primary and Secondary Prevention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyslipidemias
Diabetes Mellitus, Type 2
Hypertension
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2019-11-13
Enrollment: 387
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetic, or hypertensive or dyslipidemic patients in primary and secondary prevention

Brief summary: The aim of this study will be to evaluate the use of the nutraceutical with cardio-metabolic actions in clinical practice in addition to a Mediterranean diet scheme, normally recommended in the clinic. In particular the study will analyze how much the nutraceutical is prescribed and what are the purposes for which it is used and at what dosages.

Detailed description: The aim of this study will be to evaluate the use of the nutraceutical with cardio-metabolic actions in clinical practice in addition to a Mediterranean diet scheme, normally recommended in the clinic. In particular the study will analyze how much the nutraceutical is prescribed and what are the purposes for which it is used and at what dosages. In particular, attention will be focused on the following substances: berberine (500-1000 mg/day), monacolin (5-10 mg/day), phytosterols (0.9-1.8 g/day), resveratrol (100-500 mg/day), omega-3 (1-3 g/day), alpha lipoic acid (400-800 mg/day), curcumin (400 mg/day), psyllum (3.5 g/day), coenzyme Q10 (100-200 mg/day), inositol (250-600 mg/day), glucomannan (1-4 g/day), chitosan (800-1200 mg/day), guar fiber (10-20 g/day), L-arginine (250 mg/day).

Eligibility criteria: Inclusion Criteria:

Diabetic patients in primary and secondary prevention or Hypertensive patients in primary and secondary prevention or Dyslipidemic patients in primary and secondary prevention

Exclusion Criteria:

Patients with hystory of malignancy, and significant neurological or psychiatric disturbances, including alcohol or drug abuse.

Primary outcomes:
measure: Prevalence of the use of nutraceutical in clinical practice
timeFrame: From 2010 to 2015
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo
state: Lombardy
Study officials:
References: