linjc16/ctgov huggingface dataset:
Safety and Efficacy of ALC in Breast Cancer in Subjects With Fatigue

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the efficacy and safety of ALC in the treatment of non-anemic, breast cancer subjects who develop moderate or severe fatigue during adjuvant radiotherapy.

Detailed Description
-----------------
The objective of this study is to evaluate the efficacy and safety of ALC in the treatment of non-anemic, breast cancer subjects who develop moderate or severe fatigue during adjuvant radiotherapy

Official Title
-----------------
Safety and Efficacy of Oral Acetyl-l-carnitine (ALC) in Non-anemic Potentially Curable Breast Cancer Subjects Undergoing Adjuvant Radiation Therapy Who Have Moderate to Severe Fatigue

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: ALC and Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage 0-III breast cancer in which adjuvant radiation is indicated; Qualifying Brief Fatigue Inventory (BFI) score 6. - Exclusion Criteria: Medication to treat or manage fatigue and pain Use of erythropoietin to control anemia Clinical evidence of hypothyroidism or hyperthyroidism

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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALC<br>I g three times daily | Drug: ALC and Placebo<br>* ALC and Placebo<br>|
| Placebo Comparator: Placebo<br>1 g three times daily | Drug: ALC and Placebo<br>* ALC and Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of BFI as evaluated from Baseline to Final Visit |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Health-Related Quality of Life (HQoL) outcomes using Medical Outcomes Study Short Form Health Status Profile 12 items (MOS-SF 12 |  | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer
Genetic Variants in Nicotinamide Adenine Dinucleotide (NAD) Synthesis Pathway

Study Overview
=================
Brief Summary
-----------------
Researchers are trying to identify versions of genes as well as factors in subjects blood associated with certain types of congenital malformations(CMs). This study will help the researchers to better understand family traits that contribute to CMs.

Official Title
-----------------
Identifying Genetic Variants in Nicotinamide Adenine Dinucleotide (NAD) Synthesis Pathway in Patients With Congenital Malformations

Conditions
-----------------
Vacterl Association, Congenital Malformation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults with confirmed or putative diagnosis of VACTERL association; Families (mother, father, biological offspring) with a history of VACTERL-associated malformations Gravid or non-gravid women with a history of miscarriage and/or offspring with non-VACTERL-associated malformations Willingness to abstain from red meat, meat products, chicken, peanuts, or brewer's yeast (including beer) at least 24 hours prior to blood and urine collection Exclusion Criteria: 1) Parents of non-biological children 3) Children with congenital malformations associated with an identifiable environmental or lifestyle exposure 4) Children with congenital malformations associated with confirmed chromosomal disorders 5) Failure to abstain from red meat, meat products, chicken, peanuts, or brewer's yeast (including beer) at least 24 hours prior to blood and urine collection.

Ages Eligible for Study
-----------------
Minimum Age: 0 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 |
| --- | --- |
| History of VACTERL or congenital malformations<br>1) Adults with VACTERL association; 2) adults with a history of congenital malformations resembling VACTERL association; 3) gravid and non-gravid women with a history of recurrent miscarriage, their surviving offspring, and the biological father of offspring; 4) newly diagnosed VACTERL patients identified by healthcare providers. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic variants | Identification of genetic variants which may be associated with VACTERL association or other congenital malformations. | 2 years | 
| Targeted metabolomics | Identification of changes in metabolic pathways which may provide functional insight into the presence of genetic variants in patients with VACTERL association | 2 years |
Web-based Addiction Treatment: Cultural Adaptation With American Indians

Study Overview
=================
Brief Summary
-----------------
The purpose of the current study is to evaluate the preliminary efficacy of the Therapeutic Education System-Native Version (TES-NAV) (an efficacious web-delivered psychosocial intervention for substance use disorders adapted with American Indians/Alaska Natives [AI/AN]) to determine whether a future large-scale effectiveness trial is warranted. Specifically, a randomized controlled trial among urban AI/AN (N=80) attending outpatient addiction treatment services will be conducted to (1) estimate preliminary effect size of 12 weeks of TES-NAV on substance use disorder outcomes; (2) explore relevant moderators of TES-NAV outcomes; and (3) assess cultural factors that may correspond to variation in outcome.

Official Title
-----------------
Web-based Addiction Treatment: Cultural Adaptation With American Indians

Conditions
-----------------
Substance Use Disorders

Intervention / Treatment
-----------------
* Behavioral: TES-NAV
* Behavioral: TAU


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Identify as American Indian or Alaska Native Recent alcohol or drug use Within first 30 days of current outpatient treatment episode Exclusion Criteria: Planned treatment episode of less than 3 months Insufficient ability to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAU+TES-NAV<br>Standard outpatient addiction treatment plus Therapeutic Education System adapted for AI/AN | Behavioral: TES-NAV<br>* Internet-delivered psychosocial treatment grounded in the community reinforcement approach plus contingency management adapted for AI/AN<br>Behavioral: TAU<br>* Standard outpatient addiction treatment<br>|
| Active Comparator: TAU<br>Standard outpatient addiction treatment | Behavioral: TAU<br>* Standard outpatient addiction treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consecutive weeks of drug/alcohol abstinence | Number of consecutive weeks of abstinence from drugs and alcohol | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Digital therapeutics, Adaptation
Nutritional Status Assessment in the Elderly Suffering From Cancer : a National Cross-UCOG Survey

Study Overview
=================
Brief Summary
-----------------
Protein-energy malnutrition (PEM) is a frequent condition in patients suffering from cancer, especially the elderly. According to some studies, this malnutrition has important consequences in this population, by increasing the risk of treatment toxicities, premature interruption of chemotherapy, mortality and risks of complications. Identifying cases of malnutrition is an objective pursued by the National Nutrition and Health Programme and an important task of the Unités de Coordination en Oncogériatrie. The main goal of this study is to assess the loss of weight over the 6 month-period preceding the cancer treatment, regardless of kind (chemotherapy, targeted therapy, hormone therapy, immunotherapy, radiation therapy, surgery, comfort care), in the elderly suffering from cancer.

Official Title
-----------------
Nutritional Status Assessment in the Elderly Suffering From Cancer (NutriAgeCancer) : a National Cross-UCOG Survey

Conditions
-----------------
Cancer, Malnutrition, Elderly

Intervention / Treatment
-----------------
* Other: Nutritional assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 70 years of age Suffering from cancer Waiting for a treatment decision (whatever it is) Hospitalized in a hospital or come to consult in a hospital during the period of inclusion (2 periods of 6 weeks for two consecutive years) Affiliated to a social security system Exclusion Criteria: Patient unable to receive information regarding the study and/or provide its non objection regarding the use of its data Patient under tutorship or curatorship, deprived of freedom or placed under judicial protection

Ages Eligible for Study
-----------------
Minimum Age: 70 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 |
| --- | --- |
| Transversal<br>Elderly people, who are more than 70 years old, suffering from cancer, waiting for a treatment decision and taken care of in a hospital | Other: Nutritional assessment<br>* Observational<br>|
| Longitudinal<br>Elderly people, who are more than 70 years old, suffering from cancer, waiting for a treatment decision and taken care of in a hospital Forward-looking follow-up of 6 months of a sub-sample during the first year | Other: Nutritional assessment<br>* Observational<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| loss of weight |  | 3 to 6 month-period preceding the cancer treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
malnutrition, cancer, elderly
Refractive Accuracy of 2WIN and Portable Autorefractors

Study Overview
=================
Brief Summary
-----------------
Youth and some adults have photoscreening refractions and hand-held auto refraction before cycloplegia refraction during new and follow up eye examinations. Vector math is applied to each refraction to determine how closely the hand-held dry devices match actual refraction.

Detailed Description
-----------------
A closeness-of-fit algorithm utilizing vector transformations of astigmatism is designed and applied to 50-years of clinical international refractive experience. As a part of new and follow up comprehensive eye examinations, patients and parents consented to confirm the cycloplegic refraction to other portable refractive tools. The ability of photoscreeners 2WIN (Adaptica, Padova italy), PlusoptiX A12 (Nuremberg, Germany) and Retinomax (Righton, Tokyo, Japan) to match actual refraction is assessed utilizing the new algorithm. This algorithm could then be applied to batches of donated spectacles distend by charitable organizations worldwide if portable auto refracting devices are employed.

Official Title
-----------------
The Refractive Accuracy of Photoscreeners 2WIN and PlusoptiX and the Retinomax Auto Refractor

Conditions
-----------------
Refractive Error - Myopia Axial, Astigmatism, Accomodation, Visual Impairment, Hyperopia of Both Eyes

Intervention / Treatment
-----------------
* Device: 2WIN Photoscreener
* Device: Plusoptix A12
* Device: Retinomax


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient undergoing new or follow examination at pediatric eye and adult strabismus clinic Willing to undergo screening refractive device developmental delays included Exclusion Criteria: Intraocular lens in place

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 95 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: 2WIN Photoscreener|non-cycloplegia refraction by Adaptica 2WIN|
|Device: Plusoptix A12|non-cycloplegic refraction by Plusoptix A12 photoscreener|
|Device: Retinomax|non-cycloplegic refraction by Retinomax K+ auto refractor|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Refractive Accuracy | spherical equivalent | 1 day | 
| Refractive Accuracy | Vector transform J0 and J45 astigmatism | 1 day | 
| Refractive Accuracy | Spectacle comparison score (Percent similarity combined sphere-cylinder) | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of age | Spectacle similarity score striated by age relative to patient's ability to accommodate | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
photoscreening, photo refraction, auto refraction, spectacle dispensing
Correlation Between Friedman Classification and the Apnea Hypopnea Index (AIH) in a Population With Obstructive Sleep Apnea Syndrome (OSAS)

Study Overview
=================
Brief Summary
-----------------
Introduction: OSAS is an important disease in the actual medic scene. It is important for correlation with chronic cardiovascular disease that leaves an increase in morbimortality and socioeconomic disability to patients with apnea. Objectives: Determinate the correlation between Friedman Classification and the obstructive sleep apnea syndrome (OSAS) gravity through AHI (Apnea Hypopnea Index) in patients with OSAS for surgical indication and evaluation. Materials and Methods: The investigators evaluated and classified 84 patients, in the scale of Epworth, Friedman and how much the gravity of the SAHOS for the AHI.

Official Title
-----------------
Correlation Between Friedman Classification Ande ApneaHypopnea Index in a Population With OSAS

Conditions
-----------------
Obstructive Sleep Apnea Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Not exhibiting any exclusion criteria Age > 21 years Exclusion Criteria: Nasal tumor BMI > 40 No acceptance of study Nasal poliposis

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

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 |
| --- | --- |
| 1<br>OSAS patients | |
| 2<br>no OSAS Patient | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Friedman Classification |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea-Hypopnea Index |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Friedman Classification, Apnea-Hypopnea Index, Obstructive Sleep Apnea Syndrome
Food Study of Valacyclovir Hydrochloride Tablets 1000 mg to Valtrex® Tablets 1000 mg

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to investigate the bioequivalence of Mylan's valacyclovir hydrochloride 1000 mg tablets to GlaxoSmithKline's Valtrex® 1000 mg tablets following a single, oral 1000 mg (1 x 1000 mg) dose administration under fed conditions.

Official Title
-----------------
Single-Dose Food In Vivo Bioequivalence Study of Valacyclovir Hydrochloride Tablets (1000 mg; Mylan) to Valtrex® Tablets (1000 mg; GlaxoSmithKline) in Healthy Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Valacyclovir Hydrochloride Tablets 1000 mg
* Drug: Valtrex® Tablets 1000 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy, adult subjects, 18 years and older able to swallow medication Exclusion Criteria: institutionalized subjects history of any significant disease use of any prescription or OTC medications within 14 days of start of study received any investigational products within 30 days prior to start of study

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Valacyclovir Hydrochloride Tablets 1000 mg | Drug: Valacyclovir Hydrochloride Tablets 1000 mg<br>* 1000mg, single dose fed<br>|
| Active Comparator: 2<br>Valtrex® Tablets 1000 mg | Drug: Valtrex® Tablets 1000 mg<br>* 1000mg, single dose fed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data. |  | blood collections through 24 hours |
Sleep Apnea in Frail Elderly

Study Overview
=================
Brief Summary
-----------------
Sleep apnea syndrome is common and increases with age. In the elderly, symptoms might be different than in the youngest people, and its consequences might be severe and atypical (falls, functional and cognitive decline). Today, there is no specific tool to detect sleep apnea in the elderly. The goal of this study is to evaluate the accuracy of oximetry for detection of respiratory disturbances in sleep apnea in the hospitalized elderly.

Detailed Description
-----------------
Main goal: to define the more specific and sensitive cut-off of variability index of the oximetry to detect sleep apnea in the hospitalized elderly. Secondary goals: sleep apnea prevalence in the elderly accuracy of other oximetry parameters (saturation line, oximetry desaturation index, autonomic arousals) for detection of respiratory disturbances in sleep apnea in the hospitalized elderly to determine the clinical and biological data associated with sleep apnea in the hospitalized elderly to determine the factors associated with the record failures and its prevalence to study the prevalence of the Periodic Limb Movements of Sleep in the hospitalized elderly Study design: simultaneous records by oximetry and ventilatory polygraphy with tibial EMG in the hospitalized elderly in a geriatric readaptation unit.

Official Title
-----------------
Accuracy of Pulse Oximetry to Detect Sleep Apnea in Frail Hospitalized Patients

Conditions
-----------------
Ageing, Sleep Apnea

Intervention / Treatment
-----------------
* Device: ventilatory polygraphy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 75 ans affiliation to the French health care system Exclusion Criteria: hypoxemia with oxygenotherapy already known and treated sleep apnea syndrome mild to severe dementia (MMSE<18/30) nocturnal neurpsychological disturbances acute organic failure

Ages Eligible for Study
-----------------
Minimum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ventilatory polygraphy<br> | Device: ventilatory polygraphy<br> <br> |

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
-----------------
frail, elderly, hospitalized, sleep apnea, oximetry