linjc16/ctgov huggingface dataset:
Effect of Self-administered Exercises on PRMD

Study Overview
=================
Brief Summary
-----------------
Objective: To study the effects of self-administered exercises based on tuina techniques on the pain intensity caused by playing related musculoskeletal disorders (PRMD) of professional orchestra musicians, using numeric visual scale (NVS). Method: The investigators performed a prospective, controlled, single-blinded, randomized study with musicians suffering from PRMD. n= 69 musicians were randomly distributed into the experimental and into the control group. After an individual diagnostic assessment, specific tuina self-administered exercises were developed and taught to the participants. Musicians were instructed (educated) to repeat the exercises every day during 3 weeks. Pain intensity was measured by NVS before the intervention and after the 1st, 3rd, 5th, 10th, 15th and 20th days of self-exercising. The procedure was the same for the control group, however the Tuina exercises were executed in non-acupuncture points

Official Title
-----------------
Effects of Self-administered Exercises Based on Tuina Techniques on Musculoskeletal Disorders of Professional Orchestra Musicians

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Other: Tuina exercises
* Other: Placebo Tuina exercises


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Professional orchestra musician presenting playing related musculoskeletal pain during at least 3 weeks Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercises on real points<br>Self administered exercises were done in real treatment points | Other: Tuina exercises<br> <br> |
| Placebo Comparator: Exercises on false points<br>Self administered exercises were done in false treatment points | Other: Placebo Tuina exercises<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verbal numeric scale |  | At the baseline | 
| Verbal numeric scale |  | After one day | 
| Verbal numeric scale |  | After 3 days | 
| Verbal numeric scale |  | After 5 days | 
| Verbal numeric scale |  | After 10 days | 
| Verbal numeric scale |  | After 15 days | 
| Verbal numeric scale |  | After 20 days |
Pilot Study of the Effects of Erythritol on Endothelial Function in Patients With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The study will determine whether acute and chronic consumption of a beverage containing erythritol will improve endothelial function in patients with type 2 diabetes mellitus.

Official Title
-----------------
Pilot Study of the Effects of Erythritol on Endothelial Function in Patients With Type 2 Diabetes Mellitus

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Dietary Supplement: Erythritol-containing beverage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes mellitus Otherwise healthy Exclusion Criteria: Pregnant BMI>35 kg/m2 Long acting insulin treatment Other major illness, drug abuse Treatment with an investigational drug within 12 weeks Treatment with dietary or vitamin supplements Smoking within 3 months

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erythritol-containing beverage<br> | Dietary Supplement: Erythritol-containing beverage<br>* Orange flavored beverage containing erythritol<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brachial artery flow mediated dilation |  | Change from baseline at 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brachial artery flow-mediated dilation | Reactive hyperemia, carotid femoral pulse wave velocity, fingertip tonometry. | Change from baseline at 2 hours | 
| Reactive hyperemia |  | Change from baseline at 2 hours and 28 days | 
| Carotid femoral pulse wave velocity |  | Change from baseline at 28 days | 
| Fingertip tonometry |  | Change from baseline at 2 hours and 28 days | 
| Urine F2 isoprostanes |  | Change from baseline at 28 days | 
| C-reactive protein |  | Change from baseline at 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endothelium, diabetes mellitus, oxidative stress
Study of Bathing With Chlorhexidine Impregnated Cloths on Nosocomial Infections in the Pediatric Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
The investigators propose to conduct a large clinical study to determine if daily bathing with chlorhexidine impregnated cloths will reduce the incidence of healthcare-associated infections in the Pediatric Intensive Care Unit (PICU).

Official Title
-----------------
Impact of Daily Bathing With Chlorhexidine Impregnated Cloths on Nosocomial Infections in the Pediatric Intensive Care Unit

Conditions
-----------------
Nosocomial Infections

Intervention / Treatment
-----------------
* Drug: 2% Chlorhexidine gluconate cloth


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in pediatric intensive care unit Exclusion Criteria: Patients with a history of an allergic reaction to chlorhexidine Patients less than 2 months of age Patients with severe skin disease or burn Patients with an indwelling epidural catheter or lumbar drain

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 25 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Daily bathing with 2% chlorhexidine gluconate | Drug: 2% Chlorhexidine gluconate cloth<br>* Daily bathing<br>|
| No Intervention: 2<br>Standard bathing with soap and water basin or disposable cloth | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacteremia | incidence of bacteremia comparing those in treatment and control groups | participants were followed for the duration of ICU stay, median stay 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central Line Associated-bloodstream Infection (CLABSI) | Comparing incidence of central line-associated bloodstream infections between treatment and control groups | participants were followed for the duration of ICU stay, median stay 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intensive care unit, Healthcare associated infections (HAI), pediatric
Functional Changes After Upper Blepharoplasty

Study Overview
=================
Brief Summary
-----------------
Upper blepharoplasty is a common eyelid procedure. It associated with visual, cosmetic and functional changes .Investigator will evaluate outcome of this procedure.

Detailed Description
-----------------
baseline and postoperative 1,3,6 and 12 months full ophthalmic examination was done. Procedure is upper blepharoplasty.

Official Title
-----------------
Objective and Subjective Functional Outcomes Following Upper Blepharoplasty

Conditions
-----------------
Eyelid Diseases

Intervention / Treatment
-----------------
* Procedure: upper blepharoplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • upper eyelid Dermatochalasis Exclusion Criteria: Eyelid diseases previous eyelid surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| blepharoplasty<br>Patients will undergo blepharoplasty surgery | Procedure: upper blepharoplasty<br>* excision of excess eyelid skin with or without strip of orbicularis muscle ; with or without upper orbital fat<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual field changes | Post operative visual field changes in form of change in visual field sensitivity decibel (dB)using Humphrey Field Analyzer( HFA) II-i (Carl Zeiss Meditec ,Jena, Germany) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| corneal topographic changes | Postoperative topographic changes of the cornea in form of central keratoconus index using Pentacam HR (Oculus GmbH, Wetzlar, Germany). | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
blepharoplasty, visual field
A Randomized Controlled Trial of a Video Decision Aid in the ICU

Study Overview
=================
Brief Summary
-----------------
Randomized Controlled Trial of a Video Decision Aid in the ICU in surrogates of admitted patients.

Official Title
-----------------
Video Images of Disease for Ethical Outcomes

Conditions
-----------------
Respiratory Failure, Cardiac Event

Intervention / Treatment
-----------------
* Behavioral: video decision aid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Age 65 or older Patient does not have the capacity to make decisions Patient admitted to the ICU with life threatening illness including advanced heart, renal, lung, gastrointestinal and oncologic disease Patient has English speaking representative to make decisions on his/her behalf Patient critically ill and unlikely to survive to hospital discharge Exclusion Criteria: - Patients who are imminently dying and admitted to the ICU are excluded Wards if the state

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: usual care<br> | |
| Experimental: video arm<br>video decision aid intervention | Behavioral: video decision aid<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| preference for goal of care regarding medical interventions (e.g., CPR, intubation, etc.) |  | at baseline admission to the ICU during family meeting up to one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of medical care delivered to patient at time of death or discharge from the ICU |  | at time of death or discharge from the ICU up to one week | 
| anxiety and depression |  | anxiety and depression at follow up phone call at 3 months after ICU death or discharge | 
| satisfaction with ICU experience |  | after 3 months from time of death or discharge from ICU | 
| number of medical interventions during ICU stay |  | during time period in the ICU up to one week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICU
Diagnosing Malfunctioning Hydrocephalic Shunt Valves With a Flow Sensor

Study Overview
=================
Brief Summary
-----------------
The study hypothesis is that a transit-time ultrasonic sensor can help doctors diagnose a malfunctioning shunt valve. The study will simulate an implanted shunt flow monitoring system by placing the flow sensor and a programmable shunt valve into the patient's Extra-Ventricular Drainage line. Flow will be measured as the doctor raises/lowers the drainage bag to simulate the patient sitting up/lying down. The doctor will simulate a malfunctioning shunt by changing the valve's pressure release settings for each cycle of raising/lowering the bag. By monitoring shunt flow during these changes, the doctors hope to develop new ways to diagnose malfunctioning shunt valves when implanted shunt flow monitors become available.

Official Title
-----------------
A Flow Monitor for Pediatric Hydrocephalic Shunts - Study of Flow Sensor With the Shunt Valve

Conditions
-----------------
Hydrocephalus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with Hydrocephalus Newborn through age 20 External Ventriculostomy with an Extra-Ventricular Drainage system installed Exclusion Criteria: Not diagnosed with Hydrocephalus Older than age 20 No External Ventriculostomy with an Extra-Ventricular Drainage system installed

Ages Eligible for Study
-----------------
Maximum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Extraventricular Drainage/Pressure<br>Includes pediatric hydrocephalus patients that are in recovery from shunt explanation. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage System as a function of the shunt valve pressure release setting and drainage bag position. |  | 24 to 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recording of the pressure waveform related to the volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system. |  | 24 to 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hydrocephalus, shunt dysfunction, shunt flow
Patients Who Have Failed First Line Treatment for Locally Advanced and/or Metastatic Cervical Cancer

Study Overview
=================
Brief Summary
-----------------
Primary: To assess the overall response rate of oxaliplatin in patients with bidimensionally measurable disease at baseline. Secondary: To assess the safety and tolerability of oxaliplatin To assess time to progression and overall survival.

Official Title
-----------------
Phase II Study of Oxaliplatin in Combination With 5-fluorouracil (5-FU) and Folinic Acid (FA) in Patients Who Have Failed First-line Treatment for Locally Advanced or Metastatic Cervical Cancer.

Conditions
-----------------
Uterine Neoplasms

Intervention / Treatment
-----------------
* Drug: Oxaliplatin
* Drug: 5-FluoroUracil
* Drug: Folinic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have Locally advanced/metastatic squamous or adenocarcinoma of the cervix Prior therapy with cisplatin allowed First-line treatment may have been surgery,radiotherapy or chemotherapy either as a single agent or multi-modality therapy Must have measurable disease Histologically Proven Carcinoma of the cervix ECOG PS ≤2 No other serious concomitant illness Fully recovered from any prior therapy Lab: ANC >1500 mm³, Platelets > 100000 mm³, Creatinine ≤ 1.5 x Normal value, Bilirubin ≤ 1.5 x Normal value, SGPT (ALT) ≤ 2.5 x Normal value Exclusion Criteria: Known allergy to one of the study drugs Peripheral neuropathy > grade2 The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Oxaliplatin 85 mg/m² over 3 hours at Day 1 and Day 15. 5-FU 2,000 mg/m² over 4 hours at Day 1. Folinic acid 20 mg/m² Bolus at Day 1. | Drug: Oxaliplatin<br>* 85 mg/m²<br>Drug: 5-FluoroUracil<br>* 2,000 mg/m²<br>Drug: Folinic acid<br>* 20 mg/m²<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | Throughout the study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | Throughout the study period | 
| Overall survival |  | Throughout the study period | 
| Adverse events |  | Throughout the study period |
Nutritive Effects of Prebiotics on Early Postnatal Behavioral Measures of Tolerance

Study Overview
=================
Brief Summary
-----------------
The study is intended to measure infant comfort, behavior, and sleep when consuming study formula with prebiotics compared to infants who consume a study formula without the prebiotics.

Official Title
-----------------
Nutritive Effects of Prebiotics on Early Postnatal Behavioral Measures of Tolerance

Conditions
-----------------
Behavioral Measures of Tolerance

Intervention / Treatment
-----------------
* Other: Previously marketed cow's mlik-based infant formula
* Other: Marketed cow's milk-based infant formula with prebiotics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton, 14-35 days of age at baseline Term infant with birth weight of a minimum of 2500 grams Solely formula-fed Signed Informed Consent and Protected Health Information authorization Exclusion Criteria: History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised Feeding difficulties or formula intolerance Maternal history of illicit drug use or psychiatric disease

Ages Eligible for Study
-----------------
Minimum Age: 14 Days
Maximum Age: 35 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Previously marketed cow's milk-based infant formula<br> | Other: Previously marketed cow's mlik-based infant formula<br> <br> |
| Experimental: Marketed cow's milk-based infant formula with prebiotics<br> | Other: Marketed cow's milk-based infant formula with prebiotics<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Measures (Amount of time awake and asleep in a 72 hour period) |  | 14 weeks | 
| Infant State (Infant behavior over a 72 hour period) |  | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achieved Weight | Total weight gain | 14 weeks | 
| Achieved Length | Total length gain | 14 weeks | 
| Achieved Head Circumference | Total head circumference gain | 14 weeks | 
| Formula Intake |  | 14 weeks | 
| Fecal microbiome |  | Baseline and 112 days of age | 
| Medically-confirmed Adverse Events |  | 14 weeks | 
| Salivary Cortisol levels |  | 70 and 120 days of age | 
| Temperament - Infant Behavior Questionnaire |  | Once at 112 days of age | 
| Sleep Characteristics | Amount of waking and sleeping, number of waking and sleep episodes | 14 weeks |
A Pilot Study Using Laser Speckle Imaging of Neonate Cerebral Vasculature

Study Overview
=================
Brief Summary
-----------------
The researcher want to know whether reflections of light can be used to provide real-time pictures of blood vessel formation around infants' heads. This approach is called laser speckle imaging

Detailed Description
-----------------
This study involves imaging of superficial blood vessels in the infant's head. Analysis of reflected light images provides the type of data necessary to see the blood vessels. The researcher want to assess only feasibility of our instrument. If we determine that our instrument has sufficient spatial resolution to image directly large vessels, then we will proceed with plans for a larger study with statistical power.

Official Title
-----------------
Imaging of Neonate Cerebral Vasculature

Conditions
-----------------
Newborn Distress

Intervention / Treatment
-----------------
* Device: Laser Speckle Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: newborn Exclusion Criteria: non-new bron

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 1 Month

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Laser Speckle Imaging<br>Laser Speckle Imaging Infant Head Blood flow | Device: Laser Speckle Imaging<br>* Laser Speckle Imaging Infant Head Blood flow<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonate Cerebral Blood Flow |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
assessment