linjc16/ctgov huggingface dataset:
The Effect of Roux-en-Y Gastric Bypass on Mitochondrial Function in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Roux-en-Y gastric bypass (RYGB) surgery induces resolution of type 2 diabetes, often within days after surgery and before significant weight loss. The aim of this study is to investigate whether changes in mitochondrial function contributes to the early improvement of type 2 diabetes after RYGB.

Detailed Description
-----------------
Mitochondrial dysfunction has been linked to development of insulin resistance in the muscle and hence to the pathogenesis of type 2 diabetes. Mitochondrial function can be studied non-invasively by 31 Phosphor Magnetic Resonance spectroscopy (31PMRS). In this study we will investigate changes in mitochondrial function using the combination of 31 PMRS and Near Infra-Red Spectroscopy (NIRS) after gastric bypass.

Conditions
-----------------
Type 2 Diabetes, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients eligible for gastric bypass surgery or cholecystectomy Verified type 2 diabetes or normal glucose tolerance by OGTT Exclusion Criteria: Patients unable to fit the dimensions of the MRI-scanner

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| RYGB patients with type 2 diabetes<br>Morbidly obese patients with type 2 diabetes undergoing gastric bypass surgery | |
| RYGB patients without type 2 diabetes<br>Morbidly obese patients with normal glucose tolerance undergoing gastric bypass surgery | |
| Cholecystectomy patients without type 2 diabetes<br>Patients with normal glucose tolerance undergoing laparoscopically cholecystectomy | |

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
-----------------
Type 2 diabetes, Gastric bypass surgery, Obesity, Mitochondrial function
The Effect of Plantar Vibration Stimuli on the Balance of Older Women

Study Overview
=================
Brief Summary
-----------------
The objective of the present study was to identify the effect of direct vibration at a frequency of 100 Hz, applied to the plantar region, on the balance of women aged 60 years or older. The hypothesis is that the place improves body balance.

Official Title
-----------------
The Effect of Plantar Vibration Stimuli on the Balance of Older Women

Conditions
-----------------
Deficit Elderly Women With Body Balance

Intervention / Treatment
-----------------
* Other: vibration stimuli


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women aged 60 or older, static balance deficit verified by the One-Leg Stance test with eyes open (OLSeo) (inability to maintain position for 30 seconds with eyes open, which is associated with the risk of falling17), independent gait without the use of walking aids. Exclusion Criteria: individuals undergoing treatment to improve balance, inability to understand verbal commands, pathologies that affect balance and gait, use of medication that may affect balance, lower limb surgery in the past 12 months or participation in a physical activity program.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vibration stimuli<br> | Other: vibration stimuli<br>* A single physical therapist performed the intervention using a Novafon SK2‡ vibratory stimulation device at a frequency of 100 Hz and sway amplitude of 2 mm. The participants of the experimental group received vibratory stimulation, applied slowly by sliding the head of the device over the entire plantar region for ten minutes for each foot at every session. During the intervention, the participants remained in the supine position on an examination table.<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
-----------------
Postural Balance, Aging, Accidental Falls, Vibration
Dermacyd PH_DETINLYN Tangerine Mix (Lactic Acid) - Safety.

Study Overview
=================
Brief Summary
-----------------
To prove the safety of the gynaecological formulation in normal conditions of use.

Official Title
-----------------
Safety Dermatological Evaluation: Genital Mucous Irritation - Product Tested: Dermacyd PH_DETINLYN Tangerine Mix (Lactic Acid).

Conditions
-----------------
Hygiene

Intervention / Treatment
-----------------
* Drug: Dermacyd PH_DETINLYN Tangerine Mix (Lactic Acid)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Integral skin test in the region; Use of cosmetic product of the same category; Willingness in following the study procedures and to be present in the clinic at the days and scheduled time; Exclusion criteria: Lactation or gestational risk or gestation; Use of Anti-inflammatory, immunosuppression or antihistaminic drugs; Atopic antecedent or allergic to cosmetic product; Active cutaneous disease in the evaluation area; Diseases which cause immunology decrease, such as diabetes and HIV; Endocrinal pathologies; Intense solar exposure 15 days before the evaluation; Treatment until four months before the selection 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: 10 Years
Maximum Age: 20 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Dermacyd PH_DETINLYN Tangerine Mix (Lactic Acid) | Drug: Dermacyd PH_DETINLYN Tangerine Mix (Lactic Acid)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The absence of irritation and the good acceptability will be evaluated using one specific scale which describes the intensity of the reaction. |  | From the treatment start to the end of the study |
7 Year Follow up Analysis on the Speed of Progression of Tooth Wear Using 3D Subtraction

Study Overview
=================
Brief Summary
-----------------
Prospective observational study with 7-year follow up. 55 patients are included with moderate to severe tooth wear, whereby through informed consent the decision was taking to monitor the patients. At the baseline and 1, 3 5, and the 7-year recall digital 3D scans will be made, which will be compared and subtracted.

Detailed Description
-----------------
Prospective observational study with 7-year follow up. 55 patients are included with moderate to severe tooth wear, whereby through informed consent the decision was taking to monitor the patients. At the baseline and the 5-year recall digital 3D scans will be made, which will be compared and subtracted. Per tooth the loss of material is measured in maximum loss in height (µm) and volume (mm3) per year, using best fit alignment and 3D subtraction. The loss of tooth material will be analyzed using descriptive statistics and possible effects of jaw type, tooth type and cusp type will be analyzed using multi level regression models. The use of index teeth will be analyzed.

Official Title
-----------------
The Progression of Tooth Wear and Possible Risk Factors: a 7 Year Follow up

Conditions
-----------------
Tooth Wear, Reflux Acid, Bruxism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Generalized tooth wear A minimum of three posterior teeth (premolars and molars) per quadrant A maximum of one edentulous space in need for treatment, with a maximum span of one tooth-width Exclusion Criteria: ASA 4 Edentulous space has a span exceeding 1 tooth-width, or more than one space Functional problems (mouth opening <5cm, Temporomandibular Dysfunction) Severe periodontitis Strong gag reflex

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Studie A ESO - monitoring<br>Patients that present themselves at the clinic through referral from their dentist with tooth wear, who have no request for help, receive a non-restorative 'counseling & monitoring' strategy , in which appropriate preventive measures are recommended and wear and tear is monitored and recorded by periodically taking intra-oral photographs and 3D scans | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| degree of dental wear in height | µm per year | 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The use of index teeth | ICC correlation between ranking of patients according to whole dentition or index teeth | 7 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Progression of tooth wear
Description of Insulin Resistance in Patients With Chronic Heart Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe insulin resistance in a general chronic heart failure population, in combination with muscle strength, body composition and cardiac function. It is assumed that insulin resistance is increased in CHF patient, and that this is related to decreased muscle strength and decreased lean tissue mass.

Official Title
-----------------
Description of Insulin Resistance and Explanatory Variables in Patients With Chronic Heart Failure

Conditions
-----------------
Chronic Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of chronic heart failure for at least 6 months, clinically stable (not hospitalized) for more than 3 months prior to the onset of the study, Exclusion Criteria: glucose lowering medical therapy
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with chronic heart failure<br>other | |
| Healthy volontiers<br>other | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose tolerance | glucose and insulin concentration measurements in blood during oral glucose tolerance test | day1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c, blood lipids, BNP |  | day 1 | 
| Muscle strength: maximal strength tested on a isokinetic dynamometer |  | Day 1 | 
| Body composition: dual energy x-ray absorptiometry |  | Day 1 | 
| cardiac function: echocardiography, retrospective from hospital files |  | retrospective | 
| Health-related quality of life: MLHFQ and Eq5d |  | Day 1 |
The Prevalence and Risk Factors for Thyroid Dysfunction in Pregnant Women in Taiwan

Study Overview
=================
Brief Summary
-----------------
The investigators' aim is to enroll around 2000 patients from Taipei, Keelung, Linkou, Chiayi and Kaohsiung CGMH. All participants will receive universal thyroid function screening at 1st trimester, and those who was found to have hyperthyroidism or hypothyroidism will be referred to Endocrine department for further treatment. All participants will be followed at outpatient clinic, and their obstetric visit finding will be recorded. The maternal and neonatal outcomes will be analyzed.

Official Title
-----------------
The Prevalence and Risk Factors for Thyroid Dysfunction in Pregnant Women in Taiwan

Conditions
-----------------
Thyroid Disease Pregnancy

Intervention / Treatment
-----------------
* Drug: PTU 50 MG Oral Tablet
* Drug: Levothyroxin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women at first trimester (< 14 weeks of gestational age) Exclusion Criteria: None

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hyperthyroidism<br>Elevated fT4, low TSH | Drug: PTU 50 MG Oral Tablet<br>* to treat if the patient has hyperthyroidism<br>|
| Hypothyroidism<br>Elevated TSH, low fT4 | Drug: Levothyroxin<br>* to treat if the patient has hypothyroidism<br>|
| Euthyroid<br>Normal TSH/fT4 level | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence thyroid dysfunction | Hypothyroidism: defined as serum TSH > 2.5U/mL and decreased fT4*; Hyperthyroidism: defined as fT4 > normal range* and TSH undetectable * Serum free T4 range varies according to trimesters. | 40 weeks |
One Year Outcome of Elderly Patients Admitted to an ICU and Mechanically Ventilated

Study Overview
=================
Brief Summary
-----------------
Elderly patients are increasingly admitted in the Intensive Care Unit. Short-term outcome (e.g. hospital survival) of an ICU stay is improving in this population but little data have been published on long-term outcome. Beyond survival, outcome assessment in the elderly requires to evaluate several aspects of health: mental status, activity of daily living, pain, depression, frailty… referred by geriatrician as comprehensive geriatric assessment' (CGA). The purpose of the SENIOREA study is to evaluate one year outcome of elderly patients mechanically ventilated in the ICU by performing CGA one year after ICU admission. CGA will be performed on the patients' site of living. This prospective multicentric trial will be conducted over 8 medico-surgical ICUs.

Official Title
-----------------
One Year Outcome of Elderly Patients Admitted to an ICU and Mechanically Ventilated

Conditions
-----------------
Elderly Care

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 75 or over Admitted in a participating ICU Requiring mechanical ventilation (invasive or non invasive), initiated before ICU admission or during the 48 first hours after admission. Exclusion Criteria: Non French-speaking person Failure to obtain a consent by persons authorized to do so. Person non-beneficiary of a social security system.

Ages Eligible for Study
-----------------
Minimum Age: 75 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 |
| --- | --- | --- |
| One year outcome | Survival and health status will be assessed using comprehensive geriatric assessment (CGA) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictors of one-year outcome | The secondary assessment criteria as predictors of one year outcome will be researched among: CGA on ICU entry (based on family interview) Vitamin D blood concentration on ICU entry SOFA and SAPSII score on ICU entry Duration of organ dysfunction (ventilator support, renal replacement therapy, vasopressor) ICU length of stay | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Elderly, Intensive care unit, Outcome, Comprehensive geriatric assessment
Non Surgical Treatment of Periimplantitis

Study Overview
=================
Brief Summary
-----------------
20 consecutive adult implant patients, presenting the signs of peri-implant mucositis (probing depth ≥4 mm combined with bleeding and/or pus on probing) or initial peri-implantitis (probing depth ≥4 mm, bleeding and suppuration plus radiographic loss of supporting bone ≤30% compared with the situation after implant placement) will be included. Sites will be treated by ultrasonic debridement of the pocket, performed using a piezoceramic ultrasonic device. For the purpose, a Tip will be connected to the Handpiece Led (5 minutes/pocket) . Then, it will be followed by the subgingival use of erythritol powder applied by the use of Handpiece connected to an airflow unit 2x5 seconds/pocket. At this time the subgingival delivery of metronidazole gel will be provided. After instrumentation, patients will rinse with chlorhexidine 0.20% 3 times/day for 2 weeks. At baseline, 1 month, 3 months and 6 months the following parameters will be evaluated: Probing Pocket depth (PPD), Bleeding on Probing (BoP), Clinical Attachment Level (CAL).

Official Title
-----------------
The Use of Erythritol Powder and Locally Derived Metronidazole for the Non-surgical Treatment of Peri-implant Mucositis and Peri-implantitis.

Conditions
-----------------
Peri-Implantitis and Peri-implant Mucositis

Intervention / Treatment
-----------------
* Procedure: ultrasonic
* Procedure: erythritol
* Drug: metronidazole gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients suffering from peri-implant mucositis or peri-implantitis Exclusion Criteria: Heavy smokers current pregnant history of malignancy long-term steroidal or antibiotic therapy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ultrasonic, erythritol, metronidazole gel<br> | Procedure: ultrasonic<br> <br> Procedure: erythritol<br> <br> Drug: metronidazole gel<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| probing pocket depth change |  | baseline, 6 months | 
| bleeding on probing change |  | baseline, 6 months | 
| clinical attachment level change |  | baseline, 6 months |
Comparison of Skin Prick Testing Results of Local and Imported Pollen Allergen Extracts and Specific IgE

Study Overview
=================
Brief Summary
-----------------
Pollen allergen extracts are prepared locally and checked for efficacy by comparison to imported allergens and specific IgE.

Detailed Description
-----------------
Skin prick test (SPT) and specific IgE (sIgE) are approved for evaluation of allergen sensitization. Local allergen extracts are cheaper and more available but need standardization. Pollen allergen extracts: Bermuda, Johnson and careless weed are locally prepared and compared mean wheal diameter of skin prick test to imported allergens and also to specific IgE.

Official Title
-----------------
Comparison of Skin Prick Testing Results of Local and Imported Pollen Allergen Extracts (Bermuda ,Johnson Grasses and Careless Weed) With Specific IgE Levels.

Conditions
-----------------
Immediate Type Hypersensitivity

Intervention / Treatment
-----------------
* Biological: Pollen sensitization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive skin prick test to Bermuda or Johnson or careless weed Exclusion Criteria: Chronic diseases such as heart disease, liver, renal and severe sepsis Severe allergic symptoms such as anaphylaxis Extensive skin rashes Pregnancy

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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Pollen sensitization|Skin prick test with local and imported Bermuda, Johnson and careless weed allergen extracts at concentration of 10,000, 3,000, 1,000 and 300 AU/mL and measure specific IgE levels|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean wheal diameter of local and imported grass and weed pollens | compare mean wheal diameter of skin prick test of different concentration among local, imported allergen extract and specific IgE levels of Bermuda grass, Johnson grass and careless weed | 18 months | 
| sIgE levels of Bermuda grass,Johnson grass and careless weed | Measure level of sIgE of Bermuda grass,Johnson grass and careless weed and compare to SPT results | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
skin prick test, grass and weed pollens