linjc16/ctgov huggingface dataset:
A Study To Investigate The Effect Of A Natural Dietary Supplement On Peri-Menopausal Symptoms

Study Overview
=================
Brief Summary
-----------------
This is a randomized, masked, placebo controlled study to assess the effect on a nutritional dietary supplement on menopausal signs and symptoms in perimenopausal women.

Official Title
-----------------
A Randomized Double Blind Placebo-Controlled Study To Investigate The Effect Of A Natural Dietary Supplement On Peri-Menopausal Symptoms

Conditions
-----------------
Menopause

Intervention / Treatment
-----------------
* Dietary Supplement: proprietary formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age group between 45 and 65 at the time of informed consent. Physician diagnosis of menopause. History of substantial hot flashes > 4 episodes /day for last 2 weeks. Being post-menopausal with an intact uterus. Subject has provided signed and dated written informed consent before admission to the study. Exclusion Criteria: Concurrent hot flash therapies (prescription medications including hormone replacement therapies, gabapentin or over the counter supplements), vaginal hormonal products (rings, creams, gels) or transdermal estrogen or estrogen/progestin products for 30 days before screening visit. Women currently or previously on anticoagulants, Vitamin K antagonists like warfarin in the past 3 months, or expected to be on anticoagulants in the near future. Women involved in other clinical studies within the last 30 days. Any women who, in the opinion of the principal investigator, is at poor medical or psychiatric risk for the study.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 Years

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

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment<br>all natural dietary supplement | Dietary Supplement: proprietary formula<br> <br> |
| Other: Treatment + Omega-3s<br>all natural dietary supplement + omega-3s | Dietary Supplement: proprietary formula<br> <br> |
| Placebo Comparator: Placebo<br>vegetable oil | Dietary Supplement: proprietary formula<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hot flashes episodes | Diary | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Work productivity | Questionnaire | 12 weeks | 
| Quality of Life | Questionnaire | 12 weeks |
The Analysis of Hair Count in Healthy Taiwanese Persons by Trichoscope

Study Overview
=================
Brief Summary
-----------------
Horizontal sectioning of scalp biopsy is a better method for evaluating hair disorders than vertical sectioning because it enables the quantitative examination of hair follicles at different stages. Without having the quantitative data of normal scalp hair counts as controls, it is impossible to evaluate scalp biopsies for hair disorders. In recent years, trichoscope is more popular in analysis of hair disease. It is less invasive and simple. The aim of this study is to understand the pros and cons of trichoscpoe.

Official Title
-----------------
The Analysis of Hair Count in Healthy Taiwanese Persons by Trichoscope

Conditions
-----------------
Dermatosis

Intervention / Treatment
-----------------
* Diagnostic Test: photofinder levicam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20-50y/o adults without any scalp disorder Exclusion Criteria: adults with any scalp disorder

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: men's hair count<br> | Diagnostic Test: photofinder levicam<br>* Exam frontal, bilateral Temporal and occipital scalp by photofinder levicam and compare the pros and cons with the data from scalp biopsy.<br>|
| Placebo Comparator: women's hair count<br> | Diagnostic Test: photofinder levicam<br>* Exam frontal, bilateral Temporal and occipital scalp by photofinder levicam and compare the pros and cons with the data from scalp biopsy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average number of hairs | Exam frontal, bilateral Temporal and occipital scalp by photofinder levicam | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average hair shaft thickness | Exam frontal, bilateral Temporal and occipital scalp by photofinder levicam | 1 year | 
| Amount of Single, double and riple follicular unit | Exam frontal, bilateral Temporal and occipital scalp by photofinder levicam | 1year | 
| Amount of Empty hair follicles | Exam frontal, bilateral Temporal and occipital scalp by photofinder levicam | 1 year |
Triglyceride-Glucose Index in Diabetic Nephropathy in Type 2diaberes Mellitus Patients

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to investigate the associations between the TyG index and diabetic nephropathy in patients with type2 DM .

Detailed Description
-----------------
the triglyceride-glucose (TyG) index was proposed as a simple and reliable surrogate marker of IR, and it has been reported to be closely correlated with the HOMA-IR index. The TyG index has the advantage of being applicable in clinical practice since both triglyceride and glucose levels are routinely measured and the cost of these measurements is low.

Official Title
-----------------
Triglyceride-Glucose Index in Diabetic Nephropathy in Type 2diaberes Mellitus Patients

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with type 2 DM Exclusion Criteria: - (1) Individuals with obstructive uropathy, severe heart failure, stroke, liver disease, cancer, autoimmune disease (2) Pregnant woman. (3)End stage renal disease patients on dialysis ( glomerular filtration rate <15 mL/min/1.73 m2) or renal transplantation. (4) Type 1 Diabetic patient. (5) Albuminuria due to non-diabetic renal disease

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 75 Years

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 |
| --- | --- | --- |
| TyG index in type 2diaberes Mellitus | Detecting the association between the TyG index and diabetic nephropathy in type 2 diabetes | Baseline |
Maternal-fetal CD4 Microchimerism in HiV Exposed Newborns After Spontaneous Delivery and Cesarean Section

Study Overview
=================
Brief Summary
-----------------
The aim of this single centre study is to measure maternal CD4+ t-cells in HiV exposed Newborns after spontaneous birth in comparison to cesarean section. This may have an influence on the risk of vertical HiV transmission.

Detailed Description
-----------------
At birth maternal CD4+ t-cells from umbilical cord blood and placenta blood are measured by microchimerism-analysis. After 6 weeks the maternal CD4+ t-cells are measured in the blood of the babies blood. Additionally we look for HiV in maternal CD4+ t-cells.

Official Title
-----------------
Maternal-fetal CD4 Microchimerism in HiV Exposed Newborns After Spontaneous Delivery and Cesarean Section

Conditions
-----------------
Human Immunodeficiency Virus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • HiV exposed Newborns with normal risk of HiV transmission. Exclusion Criteria: HiV exposed Newborns wiht elevated or high risk of HiV transmission. HiV exposed Newborns of mothers not full of age. missing informed consent of at least the mother Outborns Asphyxia Major congenital defects Chromosomal anomalies

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 10 Minutes

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Spontaneous delivery<br>Approximately 15 HiV exposed Newborns with low HiV transmission risk, born via spontaneous delivery. | |
| Cesarean section<br>Approximately 15 HiV exposed Newborns with low HiV transmission risk, born via cesarean section. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal CD4+ t-cells in HiV exposed Newborns | The maternal CD4+ t-cells are measured by microchimersimanalysis | Six weeks after date of birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HiV transmission rate | Measurement of HiV PCR at the age of 6 month after birth | 6 month after birth | 
| Analysis of HiV in maternal CD4+ t-cells | HiV-PCR analysis from maternal CD4+ cells | 2 month after delivery | 
| Measurement of maternal CD8+ t-cells in the Newborn | Measurement of maternal CD8+ t-cells by microchimerismanalysis | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Human Immunodeficiency Virus, Microchimerism, Maternal-Fetal Exchange, Gestation, HiV-vertical transmission
Resurfacing Hemiarthoplasty Versus Conventional Stemmed Arthroplasty

Study Overview
=================
Brief Summary
-----------------
Hypothesis: What is the difference in disease specific quality of life between patients who receive a humeral surface replacement hemiarthroplasty verusu a conventioanl stemmed hemiarthroplasty

Detailed Description
-----------------
The purpose of this multi-centered, randomized, controlled trial will be to determine if patient self-assessed outcomes (Western Ontario Osteoarthritis of Shoulder Score- WOOS) following humeral resurfacing are superior to those following a conventional, modular, stemmed, humeral prosthesis. The first phase of this study will be a one year pilot recruitment period. This is necessary in order to determine both a center by center, and national recruitment rate, and to determine a sample size necessary for a sufficiently powered full randomized trial. If a full randomized trial is not considered feasible following Phase 1, then a prospective cohort study will be completed.

Official Title
-----------------
Resurfacing Hemiarthroplasty Versus Conventional Stemmed Hemiarthroplasty

Conditions
-----------------
Osteoarthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recent humeral resurfacing

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

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

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
Hemiarthroplasty Stemmed Resurfacing Conventional Shoulder
ALDH2 Mutation in Taiwanese Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of ALDH2 mutation in radiation associating dermatitis or mucositis in head and neck cancer patients who accept chemoradiation therapy

Detailed Description
-----------------
One-site audit. The enrolled subject is confirmed by PIs ◦◦Source data is compared to external data sources medical records, either paper or electronic case report forms. NCI CTCAE v5.0 for AE records Patient recruitment according to inclusion criteria: 1. Newly diagnosed locally head and neck squamous cell carcinoma; 2. Apply for primary chemoradiation or adjuvant chemoradiation; 3. Signed informed consent Sample size assessment: 60 subjects will be included in one year for total 120 subjects Missing data to address situations where variables are reported as missing, unavailable, non-reported, uninterpretable, or considered missing because of data inconsistency or out-of-range results Fisher's exact test is for category comparison. Kaplan-Meier analysis is for survival analysis. AE grades will be analyzed according to NCI guideline. Two-side p < 0.05 is suggested significant.

Official Title
-----------------
Correlation Between Radiation Dermatitis/Mucositis and ALDH2 Mutation in Taiwanese Head and Neck Cancer

Conditions
-----------------
Dermatitis, Mucositis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >20, <70 Newly diagnosed head and neck squamous cell carcinoma Tissue proved Signed informed consent Suitable for chemoradiation Exclusion Criteria: Uncontrolled underlying diseases Allergy to chemotherapy Uncontrolled skin diseases or mucosa diseases Previously radiation therapy over head and neck Combined with other cancer currently

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 70 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events assessed by CTCAEv5.0 | The side effects of each participant will be recorded accoiding to CTCAEv5.0 during the whole course of chemoradiation, by indicated physicians regularly | 6 months after the end of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Head and neck cancer, Asian, ALDH2
Phase I/II Study of Monoclonal Factor IX Concentrate for Factor IX Deficiency

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: Assess the safety and long-term efficacy of monoclonal factor IX concentrate in patients with factor IX deficiency.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients receive monoclonal factor IX replacement therapy as inpatients. Patients with a satisfactory response receive further therapy as needed for bleeding for up to 36 months at home.

Conditions
-----------------
Hemophilia B, Factor IX Deficiency

Intervention / Treatment
-----------------
* Drug: monoclonal factor IX replacement therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: Patients with factor IX deficiency.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: monoclonal factor IX replacement therapy|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
-----------------
hematologic disorders, rare disease
Intravitreal Bevacizumab for Age-Related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether intravitreal injection of bevacizumab is effective in the treatment of neovascular age related macular degeneration

Detailed Description
-----------------
The neovascular age related macular degeneration(AMD) is a important cause of legal blindness in adults older than 50 years. Currently the treatment is photodynamic therapy that offer stabilization and limited visual improvement after 2 years of therapy. Bevacizumab has been reported effective used as intravenous injection for AMD. But serious side effects have been reported with the use of this drug in oncologic patients. The intravitreal use has been reported in limited case reports and safety and efficacy should be determined. The purpose of this study is efficacy and safety of 2.5 mg intravitreal of bevacizumab for AMD

Official Title
-----------------
Intravitreal Bevacizumab Therapy for Neovascular Age-Related Macular Degeneration: A Pilot Study

Conditions
-----------------
Age Related Macular Degeneration

Intervention / Treatment
-----------------
* Drug: bevacizumab intravitreal injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >50 age related macular degeneration Exclusion Criteria: moderate to severe cataract glaucoma intraocular surgery diabetes mellitus non controlled hypertension coronary artery disease

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

| Intervention/Treatment |
| --- |
|Drug: bevacizumab intravitreal injection|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of visual acuity at 6 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal thickness at 6 months |  |  | 
| Leakiness in fluorangiography at 6 months |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
macular degeneration, angiogenesis, antibodies
EXPLAIN -FragilE X Registry: An exPlorative Longitudinal Study for chAracterIzation, Treatment Pathways and patieNt-related Outcomes

Study Overview
=================
Brief Summary
-----------------
This prospective observational study (registry) on Fragile X syndrome (FXS) is designed to evaluate characteristics, management and patient and caregiver-related outcomes the quality of life of Families and patients with FXS and to collect epidemiological and health economic data. EXPLAIN will report current and comprehensive data onEpidemiology data on fragile X syndrome Characterisation of the phenotype of FXS patients Description of patient characteristics (demographics, family history, comorbidity, education, working situations, care situations, insurance status) Documentation of therapeutic interventions Recording and assessment of psychosocial parameters (possibly also inclusion of family members, carers) quality of life of the carer and if possible the patient Health economic parameters and consumption of resources

Official Title
-----------------
EXPLAIN - FragilE X Registry: An exPlorative Longitudinal Study for chAracterIzation, Treatment Pathways and patieNt-related Outcomes

Conditions
-----------------
Fragile-X Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with FXS as confirmed by genetic testing Exclusion Criteria: none Other protocol-defined inclusion/exclusion criteria may apply
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| unselected Fragile-X patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient characteristics (demographics, family history, comorbidities, education, working situation, care situation, insurance status) |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epidemiology data on Fragile X Syndrome (FXS) |  | 3 years | 
| Health-economic parameters and consumption of resources |  | 3 years | 
| Therapeutic interventions and their application rationale |  | 3 Years | 
| Psychosocial parameters (poss. also inclusion of family members, caregivers) |  | 3 years | 
| Quality of life of the caregiver and possibly the patient |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fragile-X Syndrome, registry, non-interventional trial, patient-related outcome study, drug utilization, effectiveness, treatment patterns, patient characteristics under real life conditions, quality of life, economics
Optimization of PEEP for Alveolar Recruitment in ARDS

Study Overview
=================
Brief Summary
-----------------
Actual setting of PEEP in ARDS is based on tables linked to FiO2, or respiratory system plateau pressure (e.g EXPRESS Study) or set regarding esophageal pressure mesurement and transpulmonary pressure calculation. Opera study should confirm if a setting approach based on esophageal pressure is helpfull for any ARDS patient in ICU without deleterious side-effect.

Official Title
-----------------
Optimization of PEEP for Alveolar Recruitment in ARDS

Conditions
-----------------
ARDS

Intervention / Treatment
-----------------
* Device: esophageal pressure mesurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ARDS Stades 2 and 3 with invasive ventilation (EXPRESS settings) within 3 to 12 hours Exclusion Criteria: less 18 years, pregnancy, intracardiac shunt, esophageal catheter cons-indicated

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 |
| --- | --- |
| ARDS<br>ARDS patients achieving stades II and III of Berlin 2011 Classification | Device: esophageal pressure mesurement<br>* EXPRESS study ventilatory setting the optimization of PEEP with esophageal pressure mesurement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PaO2/FiO2 ratio |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vd/Vt ratio |  | 24 hours | 

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