linjc16/ctgov huggingface dataset:
Effects of Earplugs on Sleep and Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
The main goal of this study is to assess whether use of earplugs has any effect on sleep, sleep apnea, and daytime sleepiness in individuals who snore.

Official Title
-----------------
Effects of Earplugs on Sleep and Sleep Apnea

Conditions
-----------------
Sleep Disordered Breathing

Intervention / Treatment
-----------------
* Other: Soft earplugs are worn during sleep study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults, ages 18 or older Scheduled at the University of Michigan Sleep Disorders Center for a diagnostic polysomnogram to evaluate for sleep-disordered breathing Exclusion Criteria: Medical, psychiatric or other conditions that would interfere with interpretation of the results of the sleep studies or the subject's ability to complete the Stanford Sleepiness Scale

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Earplugs<br>Subjects randomized to this arm of the study will wear earplugs during their baseline sleep study (polysomnogram). | Other: Soft earplugs are worn during sleep study<br>* Subjects are asked to wear earplugs when possible for 3-5 nights prior to their baseline sleep study. On the night of their sleep study they are randomized to either wears earplugs or no earplugs groups.<br>* Other names: Howard Leight (Sperian) Max-1/3303361 uncorded earplugs, NRR33, SNR 37dB;|
| No Intervention: Comparison group<br>Subjects randomized to the comparison arm will not wear earplugs during their baseline sleep study. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep measures (rates of apneas and hypopneas, oxygen desaturation, arousals, sleep stages, respiratory cycle-related EEG changes [RCREC]) |  | up to 2 years after the sleep study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective sleepiness measures (Stanford Sleepiness Scale) |  | on awakening after the sleep study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
snoring, sleep disordered breathing, polysomnography, sleep fragmentation
Effect of Daily Infusion Time of Immunotherapy on Overall Survival in NSCLC

Study Overview
=================
Brief Summary
-----------------
This study aims to explore the effect of different infusion times (day or night) on the efficacy of immune checkpoint inhibitors on the basis of real-world efficacy of immunotherapy for advanced squamous/non-squamous non-small cell lung cancer.

Official Title
-----------------
Effect of Daily Infusion Time of Immunotherapy on Overall Survival in Patients With Advanced Non-small Cell Lung Cancer

Conditions
-----------------
Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Procedure: Time of immunotherapy infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with untreated non-small cell lung cancer ECOG score 0-2 Asymptomatic brain metastases Driver gene was negative At least 1 measurable lesion First-line patients received immunological monotherapy or immunological combined chemotherapy Exclusion Criteria: Failure to follow the standard treatment plan during diagnosis and treatment; Lack of clinical diagnosis and treatment information or loss of follow-up; Can't tolerate immunotherapy or ECOG score greater than 2

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: morning group<br>The immunotherapy infusion is after 9:00 a.m | Procedure: Time of immunotherapy infusion<br>* Time of immunotherapy infusion<br>|
| Experimental: afternoon group<br>The immunotherapy infusion is after 15:00 p.m | Procedure: Time of immunotherapy infusion<br>* Time of immunotherapy infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects | 1 year | 
| OS | Defined as the time from the start of treatment to the death of the subject due to any cause. | 1 year |
Alcohol in the Treatment of Obesity

Study Overview
=================
Brief Summary
-----------------
This pilot study looks at the relationship of moderate alcohol consumption on weight loss.

Detailed Description
-----------------
We hypothesize that individuals who consume a moderate amount of alcohol, such as a glass or two of wine daily, will lose more during a weight-reduction program than will those who do not, if equal calories are administered to both groups. The purpose of this pilot study is to look at the relationship of alcohol in weight loss. The current standard in weight loss programs is to eliminate alcohol from the diet. We propose to enroll 50 females enrolled at the Structure House residential diet program in Durham, North Carolina. Half or the subjects will receive 150 calories in the form of white wine, 3.5 ounce with lunch and 3.5 ounces with dinner. The other half of the subjects wil receive their 150 calories in their regular diet. All participants are asked not to consume any additional alcohol. Participants will be weighed daily. The study lasts four weeks.

Official Title
-----------------
Alcohol in the Treatment of Obesity

Conditions
-----------------
Obesity, Weight Loss, Alcohol Drinking

Intervention / Treatment
-----------------
* Other: white wine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >21, female, BMI ≥ 30, no history of substance abuse, prior alcohol use of at least one drink/week; Exclusion: pregnancy, breast feeding, previous history of alcohol abuse, liver disease.

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>This group will receive 3.25 ounces of white wine with lunch and dinner | Other: white wine<br>* 3.25 ounces of white wine twice a day with lunch and dinner<br>|
| No Intervention: 2<br>This group receives the same amount of calories as the experimental group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| An outcome measure for the study is an increase weight loss or no change in the wine group of .05% over the 4 weeks of the study |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants will also be asked to complete a visual satiety scale each day before and after lunch and dinner. |  | 4 weeks |
Study Evaluating Vancomycin-Resistant Enterococci in a Hematology Unit

Study Overview
=================
Brief Summary
-----------------
To determine the impact of the restriction of the third and forth generation cephalosporins on the reduction of intestinal colonization or infection with vancomycin-resistant enterococci (VRE) in a surgical intensive care unit (SICU)

Official Title
-----------------
Effects on the Emergence and Transmission of Vancomycin-Resistant Enterococci After Changes in Antibiotic Use in a Hematology Unit.

Conditions
-----------------
Gram-Positive Bacterial Infections

Intervention / Treatment
-----------------
* Drug: Piperacillin/tazobactam and other β-lactam/β-lactamase


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients admitted to or transferred to the SICU. Eligible patients will be patients of either sex, 18 years of age or older who are admitted or transferred to the SICU. Provide written informed consent Exclusion Criteria: Patients who have hypersensitivity to penicillin, cephalosporins or beta-lactamase inhibitors. Females who are pregnant and breast feeding Any underlying conditions or non-infectious diseases that will be ultimately fatal within 48 hours. Those who have already been participating other clinical study related with antibiotics.

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

| Intervention/Treatment |
| --- |
|Drug: Piperacillin/tazobactam and other β-lactam/β-lactamase|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bacterial Infections
Effects of Two Techniques of Mobilization in the Dorsiflexion on Patients With Chronic Ankle Instability

Study Overview
=================
Brief Summary
-----------------
Restrictions on ankle dorsiflexion are common in subjects with chronic ankle instability (CAI). In fact, this is one factor that can contribute to the recurrence of such injuries. Passive mobilization techniques to improve ankle dorsiflexion are commonly used in physiotherapy treatments. However, no studies have compared manipulative techniques of mobilization techniques in subjects with chronic ankle instability. The aim of this study is to compare the effects of two mobilization techniques on ankle dorsiflexion in patients with chronic ankle instability.

Official Title
-----------------
The Effects of Two Techniques of Mobilization in the Improvement of Dorsiflexion on Chronic Instability Ankles. A Double Blind Randomized Controlled Trial

Conditions
-----------------
Chronic Instability of Joint

Intervention / Treatment
-----------------
* Other: HVLA
* Other: MWM
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with chronic ankle instability Exclusion Criteria: Acute or subacute ankle sprain. Recent lesions in lower extremities.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 40 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HVLA<br>High velocity and low amplitude traction manipulation on the ankle joint | Other: HVLA<br>* High velocity and low amplitude manipulation in traction of subtalar jonit<br>|
| Experimental: MWM<br>Mobilization with movement on ankle joint as Mulligan | Other: MWM<br>* Mobilization with movement as Mulligan for increase dorsiflexion of the ankle in weight bearing<br>|
| Sham Comparator: placebo<br>Contact without therapeutic effect | Other: placebo<br>* Manual contact during a period of time similar of teh other interventions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-intervention ankle dorsiflexion | Ankle dorsiflexion is measured by the weight-bearing lunge method | pre-intervention | 
| Inmediately post-intervention ankle dorsiflexion | Ankle dorsiflexion is measured by the weight-bearing lunge method | inmediately post-intervention | 
| ten minutes post-intervention ankle dorsiflexion | Ankle dorsiflexion is measured by the weight-bearing lunge method | ten minutes post-intervention | 
| 24 hr post-intervention ankle dorsiflexion | Ankle dorsiflexion is measured by the weight-bearing lunge method | 24 hr post-intervention | 
| 48 hr post-intervention ankle dorsiflexion | Ankle dorsiflexion is measured by the weight-bearing lunge method | 48 hr post-intervention |
Non-invasive Brain Stimulation for the Treatment of Psychiatric Disorders

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether transcranial direct current stimulation (tDCS) is effective in the treatment of psychiatric disorders in which available treatments are either ineffective or not tolerated

Detailed Description
-----------------
Depending on the specific psychiatric disorder, inhibitory or stimulating neuromodulation will be applied over the cortical region of interest, found according to the relevant scientific publication on neurophysiology of psychiatric disorders

Official Title
-----------------
Non-invasive Brain Stimulation for the Treatment of Psychiatric Disorders

Conditions
-----------------
Mental Disorders

Intervention / Treatment
-----------------
* Device: transcranial Direct Current Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a psychiatric disorder in which available treatment are either ineffective or not tolerated Exclusion Criteria: implantable active devices

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: transcranial Direct Current Stimulation<br>daily or twice-a-day administration of transcranial Direct Current Stimulation | Device: transcranial Direct Current Stimulation<br>* daily or twice-a-day administration of transcranial Direct Current Stimulation from a minimum of 10 session to a maximum of 20<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Psychiatric rating scales scores at immediate post-treatment and at one-month and at three-month follow-up visits |  | Time points: T0=baseline; T1=immediate post-treatment; T2=one-month follow-up visit; T3=3-months follow-up visit |
A Registry for the Food Allergy Community

Study Overview
=================
Brief Summary
-----------------
The FARE Patient Registry will serve as a prospective, observational food allergy reporting system that stores detailed health and other basic information about patients' real-world experiences with food allergies, to encourage open sharing of de-identified data and participation in clinical trials. The FARE Patient Registry intends to make and support scientific discoveries by enabling the food allergy community to participate directly in research.

Official Title
-----------------
The FARE Patient Registry: A Registry for the Food Allergy Community

Conditions
-----------------
Anaphylaxis, Food Sensitivity, Food Hypersensitivity, Eosinophilic Esophagitis, Food Intolerance, Food Allergy in Infants

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals with diagnosed food allergy Exclusion Criteria: Individuals without food allergy
Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Create a registry to characterize the extent of food allergy, its etiology and other factors that contribute to disease development. |  | 2023 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
food allergy
The Effect Of Core Stability Training In Temporomandibular Disorders

Study Overview
=================
Brief Summary
-----------------
This study is to investigate the effect of Core stability training on pain, function, quality of life, sleep quality, body posture, foot posture, oral habits and kinesiophobia in individuals with temporomandibular disorder. Materials and Methods: The study included 40 people over the age of 18, who were diagnosed with temporomandibular disorder from the dentist.

Official Title
-----------------
The Effect Of Core Stability Training on Pain, Function and Quality of Life in Individuals With Temporomandibular Disorders

Conditions
-----------------
Temporomandibular Disorder

Intervention / Treatment
-----------------
* Other: Core stability training
* Other: Rocabado Exercises


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients aged 18-55, diagnosed with temporomandibular disease by a dentist Exclusion Criteria: Having received another treatment for TMR other than the use of night plate in the last 6 months Having a disease that can cause facial pain such as sinusitis, migraine, tension headache, trigeminal neuralgia Skeletal system fractures

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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
Interventional Model Description: Randomised Controlled Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Core stability Group<br> | Other: Core stability training<br>* Core stability exercises<br>|
| Active Comparator: Control Group<br> | Other: Rocabado Exercises<br>* Exercises for Temporomandibular Disorders<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Posture | New York Posture Scale | 6 weeks | 
| Sleep Quality | Pittsburg Sleep Quality Index | 6 weeks | 
| Kinesiophobia | Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-TMD) | 6 weeks | 
| Oral Habits | Oral Behavior Checklist | 6 weeks | 
| Jaw Function | Jaw Functional Limitation Scale-20 | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Foot Posture | Foot Posture Index-6 | 6 weeks | 
| Graded Pain | Graded Chronic Pain Scale | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
core stability, pain, quality of life, function, temporomandibular disorder
Effect of Adjuvant Therapy by Sorafenib, Oxaliplatin and S-1

Study Overview
=================
Brief Summary
-----------------
The study is designed to investigate the effect of adjuvant therapy by Sorafenib, Oxaliplatin and S-1 to prevent the tumor recurrence for hepatocellular carcinoma after liver transplantation

Official Title
-----------------
Effect of Adjuvant Therapy by Sorafenib, Oxaliplatin and S-1o Prevent the Tumor Recurrence for Hepatocellular Carcinoma After Liver Transplantation: A Randomized Controlled Study

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Drug: Sorafenib
* Drug: S-1
* Drug: Oxaliplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hepatocellular carcinoma after liver transplantation Major organ (heart, lung and brain) function was normal Exclusion Criteria: Any active infectious process The presence of clinically confirmed extrahepatic metastasis Postoperative dysfunction of any organ

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sorafenib<br>Leading 4 cycles: S-1 + Oxaliplatin Q3W + Sorafenib daily Sequential : Sorafenib maintenance | Drug: Sorafenib<br> <br> Drug: S-1<br> <br> Drug: Oxaliplatin<br> <br> |
| Experimental: S-1 and Sorafenib<br>Leading 4 cycles: S-1 + Oxaliplatin Q3W + Sorafenib daily Sequential : 4 cycles of S-1 + Sorafenib maintenance | Drug: Sorafenib<br> <br> Drug: S-1<br> <br> Drug: Oxaliplatin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Recurrence (TTR) | Time to Recurrence | within five years after liver transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | Overall survival | within the five years after liver transplantation |