linjc16/ctgov huggingface dataset:
Safety and Preliminary Efficacy Study of MTS-01 for the Prevention of Alopecia Induced by WHole Brain Radiotherapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if MTS-01 is effective in preventing radiotherapy-induced hair loss in patients receiving whole brain radiotherapy

Detailed Description
-----------------
Hair loss (alopecia) occurs commonly as a result of external beam radiotherapy to the brain, and contributes to the social isolation and distress of patients with cancer. MTS-01 is a topical gel formulation that can be applied to the scalp during delivery of radiotherapy

Official Title
-----------------
A Phase II, Double-Blind Placebo-Controlled, Parallel Group Study of the Safety and Preliminary Efficacy of MTS-01, for the Prevention of Alopecia Induced by Whole Brain Radiotherapy

Conditions
-----------------
Alopecia

Intervention / Treatment
-----------------
* Drug: MTS-01
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: is >/= 18 years of age Has metastatic cancer to the brain for which palliative or prophylactic whole brain radiotherapy is recommended. A histological diagnosis of cancer will be required, however, a biopsy of the brain metastases will not be required Can understand and sign the IRB/IEC approved informed consent, can communicate with the Investigator, and can understand with the requirements of the protocol has signed the HIPAA authorization 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo group | Drug: Placebo<br>* Placebo gel in 100 ml tube, two 100 ml tubes prior to each radiation treatment<br>|
| Active Comparator: 2<br>Control Group | Drug: MTS-01<br>* MTS-01 7% gel in 100 ml tubes, two 100 ml tubes prior to each radiation treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator assessment of hair loss using a 10 point scale |  | up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A time to event analysis of the hair loss |  | up to 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radiotherapy, induced
A Comparison of Two Protocol for Maxillary Molar Intrusion Buccal Miniscrew and TPA Versus Vertical Holding Appliance

Study Overview
=================
Brief Summary
-----------------
this study is to compare the dental and skeletal changes caused by the intrusion of maxillary first molars buccal miniscrew and TPA versus vertical holding appliance using lateral cephalometry.

Official Title
-----------------
A Comparison of Two Protocol for Maxillary Molar Intrusion Buccal Miniscrew and TPA Versus Vertical Holding Appliance Randomized Controlled Trial

Conditions
-----------------
Dental Intrusion, Mandibular Rotation, ANB , SNA, SNB, Openbite Teeth &#X7C; Teeth and Gum &#X7C; Dental

Intervention / Treatment
-----------------
* Biological: buccal miniscrew and TPA
* Biological: vertical holding appliance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suffering class I or II with AOB. AOB ranged between 3-7 mm assessed from cephalometry. Patients with excess in posterior dentoalveolar height according to Burrstone . Patients with good oral hygiene and general health. Patients with no previous orthodontic treatment. Good quality of lateral cephalometry. Exclusion Criteria: Skeletal open bite previous orthodontic treatment

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 20 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Buccal miniscrews with TPA<br>active comparator double center | Biological: buccal miniscrew and TPA<br>* intrusion of molars<br>|
| Active Comparator: vertical holding appliance<br>active comparator double center | Biological: vertical holding appliance<br>* intrusion of molars<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of dental | rate of maxillary molar intrusion by cephalometry | Post-intervention at 6 months | 
| amount of skeletal changes | amount of vertical overlap by cephalometry | Post-intervention at 6 months | 
| amount of skeletal changes | amount of mandibular rotation by cephalometry | Post-intervention at 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TPA, Miniscrew, intrusion, vertical holding appliance, cephalometry
Electronically Connected Health Coaching in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Patients with Type 2 Diabetes randomly allocated to the intervention arm (health coaching + smartphone-based health promotion software) will have significantly better Hemoglobin A1c levels at 6 months post-intervention than patients with Type 2 Diabetes allocated to the control arm (health coaching alone).

Detailed Description
-----------------
Inclusion criteria: all participating patients have been diagnosed with Type 2 Diabetes, are between 25 and 70 years of age, have a regular primary care physician, and have HbA1c levels > or = to 7.3. Exclusion criteria: Axis I and II psychiatric disorders. Primary outcome: HBA1c at 6 months follow up. Secondary outcome: Centre for Epidemiological Studies Depression Scale

Official Title
-----------------
Electronically Connected Health Coaching in Improving Type 2 Diabetes Self Management - Phase III Trial

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

Intervention / Treatment
-----------------
* Behavioral: Lifestyle counseling with smartphone
* Behavioral: Lifestyle counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Type 2 Diabetes Fluency in English and/or Spanish Exclusion Criteria: > 75 years of age

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Experimental: Lifestyle counseling with smartphones<br>Lifestyle counseling assisted by smartphones | Behavioral: Lifestyle counseling with smartphone<br>* Lifestyle counseling with health promoting smartphone software<br>|
| Active Comparator: Lifestyle counseling<br>Lifestyle counseling | Behavioral: Lifestyle counseling<br>* Lifestyle counseling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c | Finger prick A1c test or lab test | 6 months follow up from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Center for Epidemiological Studies Depression Scale | Self report measure of psychological distress | 6 months follow up from baseline assessment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes
Metabolomic Analysis of Exhaled Breath Condensate in Asthmatics

Study Overview
=================
Brief Summary
-----------------
Asthma is a chronic inflammatory airway disease. Significant heterogeneity exists in the clinical manifestations and treatment responses in these patients. Metabolomics is a large-scale approach to monitoring as many as possible of the compounds involved in cellular processes in a single assay to derive metabolic profiles. Compared with genomics or proteomics, metabolomics reflects changes in phenotype and therefore function. Up to now, few studies have evaluated the role of metabolomic analysis in the diagnosis and prognostic evaluation of airway disorders. Collection of exhaled breath condensate (EBC) is a newly developed, noninvasive method that may allow clinicians and researchers to assess biochemical profiles in the alveolar lining fluid. This study will apply metabolomics to examine the biomarkers in the EBCs, serum and urine specimens in adult asthmatics.

Detailed Description
-----------------
The aims of this study are: 1. Metabolomic profiling of the exhaled breath condensate (EBC), serum and urine specimens in adult asthmatics; 2. Correlation between metabolomic profiles of these specimens with the severity and control of asthma; 3. Comparing metabolomic profiles in asthmatics with different phenotypes and endotypes; 4.Comparing metabolomic profiles obtained from asthmatics during stable and acute exacerbation periods; 5. Comparing metabolomic profiles in asthmatics before and after inhaled corticosteroid therapy.

Official Title
-----------------
Metabolomic Analysis of Exhaled Breath Condensate, Plasma and Urine Specimens in Adult Asthmatics

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20-90 years Diagnosis of asthma based on the GINA guideline Exclusion Criteria: Patient with cancer Patient with long-term ventilator use

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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 |
| --- | --- |
| asthma<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
-----------------
Asthma, metabolomics, exhaled breath condensate
Functional Plasticity of Human IL-17-producing CD8+ T Cells

Study Overview
=================
Brief Summary
-----------------
Human Tc17 cells (IL-17-producing CD8+ T cells) have been found to contribute to different kinds of human inflammatory and malignant diseases. Previous studies indicate that Tc17 cells can convert to Tc1 cells (IFN-γ-producing CD8+ T cells) in tumor bearing mice to exert anti-tumor effect. Base on these results in murine models, human Tc17 may have potential in developing cancer immunotherapy. However, there is limited evidence to reveal the characteristics and functional plasticity of human Tc17 cells. In this proposal, we aim to optimize the differentiation of Tc17 cells and then investigate whether the reprograming of Tc17 to Tc1 cells can promote the anti-tumor cytotoxicity. Preliminarily, we isolated CD8+ T cells from the peripheral blood mononuclear cells of healthy donors to induce Tc17 differentiation. Human CD8+ T cells were stimulated with anti-CD3/anti-CD28 antibodies, TGF-β, IL-1β, IL-6, IL-23, IL-2, anti-IFN-γ, and anti-IL-4 antibodies. After 10 days in culture, there were 4% of IL-17A+IFN-γ- and 7% of IL-17A+IFN-γ+ CD8+ T cells. However, IFN-γ+ CD8+ T cells still represented high percentage, although it's significantly lower than that in Tc1 cells. Our preliminary study demonstrated that Tc17 cells expressed lower levels of cytotoxic molecules than Tc1 cells. We will further test if the expressions of cytotoxic molecules, including perforin and granzyme B, and EOMES will be enhanced by various cytokines. Ultimately, we will evaluate the functional plasticity of Tc17 cells under various cytokine stimulation. Collectively, success of this project will establish more insight for human Tc17 cells and provide the information for future developing human CD8+ T cell-mediate immunotherapy.

Official Title
-----------------
Functional Plasticity of Human IL-17-producing CD8+ T Cells

Conditions
-----------------
IL-17+ CD8 T Cells in Cancer Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cancer patients Exclusion Criteria: pregnancy

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional plasticity of IL-17+ CD8 T cells | To skew human IL-17+ CD8 T cells and add specific cytokines to convert IL-17 CD8 T cells to IFN-gamma CD8 T cells | culture cells for 16 days |
Metabolic Effects of Acute Cortisol Withdrawal in Adrenal Failure

Study Overview
=================
Brief Summary
-----------------
Effects of adrenal steroids is generelly drawn from studies of hypercortisolism. The effects of physiological cortisol substitution and withdrawal is studied and related to the clinical syndrome of adrenal insufficiency.

Official Title
-----------------
Effects of Cortisol on Carbohydrate, Lipid, and Protein Metabolism; Studies of Acute Cortisol Withdrawal in Adrenocortical Failure.

Conditions
-----------------
Addison Syndrome

Intervention / Treatment
-----------------
* Drug: hydrocortisone substitution therapy versus withdrawal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female adrenal failure Age 18-50 Written informed content Exclusion Criteria: Diabetes mellitus Cancer Thromboembolic events Pregnancy and lactation Heart disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: hydrocortisone substitution therapy versus withdrawal|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin sensitivity |  |  | 
| local protein turnover |  |  | 
| whole body protein turnover |  |  | 
| glucose metabolism |  |  | 
| serum metabolites |  |  | 
| serum hormone levels |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cortisol, adrenal insufficiency, glucose metabolism, protein metabolism, lipid metabolism, insulin sensitivity.
The Clinical and Subjective Performance of Three Different MPDS With Silicon Hydrogel Lenses

Study Overview
=================
Brief Summary
-----------------
The purpose of the clinical investigation is to assess the clinical and subjective performance of three novel multipurpose disinfecting solutions (MPDS) in daily wear with two silicone hydrogel contact lenses (Lotrafilcon B and Comfilcon A).

Official Title
-----------------
The Evaluation of the Clinical and Subjective Performance of Three Different Contact Lens Care Solutions With Silicon Hydrogel Lenses

Conditions
-----------------
Adverse Reaction to Contact Lens Solution

Intervention / Treatment
-----------------
* Device: Contact lens care solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age above 18 experienced contact lens user good health (self-reported) Exclusion Criteria: eye disease or eye operations pregnancy medication that can affect sight

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MPDS1<br>Contact lens care solution | Device: Contact lens care solution<br>* Comparison of clinical and subjective performation of the contact lens care solutions used with two types of contact lenses<br>|
| Active Comparator: MPDS2<br>Contact lens care solution | Device: Contact lens care solution<br>* Comparison of clinical and subjective performation of the contact lens care solutions used with two types of contact lenses<br>|
| Active Comparator: MPDS3<br>Contact lens care solution | Device: Contact lens care solution<br>* Comparison of clinical and subjective performation of the contact lens care solutions used with two types of contact lenses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical performance | TBUT, conjunctival and limbal hyperemia, corneal vascularization, epithelial and stromal oedema, corneal infiltrates, endothelial regularity, corneal staining and papillar conjunctivitis | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective performance | E.g. Comfort | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contact lens, Care solution, MPDS, comfort
Hormonal Contraception in Healthy Young Men (P42306)(COMPLETED)(P06057)

Study Overview
=================
Brief Summary
-----------------
Male volunteers receive a new hormonal contraceptive consisting of an implant releasing a hormone and hormone injections in order to investigate the suppressive effect on sperm production and reversibility of sperm production after end of treatment.

Official Title
-----------------
A Phase II -b, Placebo-Controlled Trial Investigating the Efficacy, Safety and Pharmacokinetics of a Subcutaneous Etonogestrel Implant Combined With i.m. Testosterone Undecanoate for Male Contraception

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Drug: etonogestrel with testosterone undecanoate
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male Mentally and physically healthy BMI between 18 and 32 kg/m^2 Two pre-treatment semen samples > 20 million/ml with normal morphology and motility Exclusion Criteria: History or presence of psychiatric disease, liver disease, renal disease, diabetes, cardiovascular disease, any malignancy, prostatic disease, or genitourinary infection PSA > 2.5 ng/ml Use of drugs known to interfere with pharmacokinetics of steroids Use of lipid-lowering drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>etonogestrel with testosterone undecanoate | Drug: etonogestrel with testosterone undecanoate<br>* 42 or 44 weeks with etonogestrel implant and testosterone undecanoate injections every 10 to 12 weeks<br>|
| Placebo Comparator: Arm 2<br>Placebo | Drug: Placebo<br>* 42 or 44 weeks with placebo implant and placebo injections<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of men who had a sperm concentration of 1 million/ml or less at week 16. |  | Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Semen Parameters |  | At several timepoints during treatment | 
| Reversibility of Suppression |  | Post-Treatment | 
| Hormones |  | At several timepoints | 
| Pharmacokinetics |  | At several timepoints | 
| Safety |  | At several timepoints |