linjc16/ctgov huggingface dataset:
Resilience and Quality of Life in Patients With Gynaecological Carcinomas and Chronic Gynaecological Diseases

Study Overview
=================
Brief Summary
-----------------
The intended pilot project aims at evaluating the feasibility and acceptability of questionnaires about resilience and quality of life in two different patient groups (either with a gynaecological carcinoma ora chronic gynaecological disease). The results provided by this pilot study will build the basis of an upcoming, larger project including these questionnaires and the main objective of assessing resilience. More precisely, the study aims at answering the following questions. How is the overall resilience and quality of life in the target population at one assessment point? Are the instruments used in this pilot feasible for the target population when assessing resilience and quality of life?

Official Title
-----------------
Resilience and Quality of Life in Patients With Gynaecological Carcinomas and Chronic Gynaecological Diseases: A Pilot Study

Conditions
-----------------
Gynecologic Disease, Gynecologic Cancer

Intervention / Treatment
-----------------
* Other: Connor Davidson Resilience Scale (CD-RISC 10)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female, >18 years old, german speaking exclusion criteria: - insufficient study language skills

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| gynecological cancer<br>all patients having a consultation doctor during the recruiting time | Other: Connor Davidson Resilience Scale (CD-RISC 10)<br>* questionnaires about resilience (Connor Davidson Resilience Scale(CD-RISC 10)) and quality of life (EQ-5D-5L)<br>* Other names: EQ-5D-5L;|
| chronic gynecological disease<br>all patients having a consultation doctor during the recruiting time | Other: Connor Davidson Resilience Scale (CD-RISC 10)<br>* questionnaires about resilience (Connor Davidson Resilience Scale(CD-RISC 10)) and quality of life (EQ-5D-5L)<br>* Other names: EQ-5D-5L;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| resilience measured by questionnaire | Total Score of the resilience questions is 0 to 40, 10 subscales from 0 to 4 (summed up for total score), the higher the score the better the resilience | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life measured by questionnaire | Questions about Quality of life: Total score 0-25, 5 subscales 0 to 5 (summed up for total score), the higher the score the lower is Quality of life. | up to 1 year |
Comparison of Metformin, Repaglinide or the Combination of Both in Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to compare the efficacy of metformin and repaglinide used alone or combined administered as initial treatment in subjects with type 2 diabetes in which diet and exercise have failed.

Official Title
-----------------
Multicentre, Randomised, Comparative, Open, Three Armed Parallel Group Study on the Use of Metformin, Repaglinide or the Combination of Both in Type 2 Diabetic Patients After Failure of Dietary Measures

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

Intervention / Treatment
-----------------
* Drug: metformin
* Drug: repaglinide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with type 2 diabetes Treated by diet for at least 3 months Never treated with hypoglycaemic drugs HbA1c (glycaemic haemoglobin A1c) on inclusion time superior to 6.5% Exclusion Criteria: Very symptomatic diabetes Advanced vascular complications Manifest renal failure Manifest hepatic disease Pregnancy, breast feeding or intention to become pregnant or if it is considered that the patient is not using adequate contraceptive measures. Adequate contraceptive measures are considered to be an intrauterine device, oral contraceptives and barrier methods

Ages Eligible for Study
-----------------
Minimum Age: 35 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: Met<br> | Drug: metformin<br>* Adminstered orally during the three main meals for 24 weeks<br>|
| Active Comparator: Rep<br> | Drug: repaglinide<br>* Administered orally before the three main meals for 24 weeks<br>|
| Active Comparator: Met+Rep<br> | Drug: metformin<br>* Adminstered orally during the three main meals for 24 weeks<br>Drug: repaglinide<br>* Administered orally before the three main meals for 24 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of % HbA1c (glycosylated haemoglobin) in blood |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the mean body mass index calculated as weight in kilograms divided by the square of height in metres |  |  | 
| Incidence of clinical and/or biochemistry hypoglycaemia episodes |  |  | 
| Incidence of adverse events |  |  | 
| Presence of laboratory abnormalities in routine blood analyses |  |  | 
| Change of the blood pressure and/or heart rate |  |  | 
| Treatment compliance |  |  |
Genome-wide Study for Disease Susceptibility Gene(s) in Patients With Hand Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
This is a case-control study involving one medical center and one research institute to develop a data-set containing a minimum of 100 osteoarthritis cases, minimum of 100 independent controls of similar gender ratio and a minimum of 100 disease controls (cases with hip and/or knee OA) to associate DNA sequence (allelic) variations in candidate genes with osteoarthritis phenotypes. This study is intended to begin at the Institute of Biomedical Sciences at Academia Sinica (which includes National Genotyping Center (NGC) and National Clinical Core (NCC)), National Taiwan University Hospital.

Official Title
-----------------
Genome-wide Study for Disease Susceptibility Gene(s) in Patients With Hand Osteoarthritis

Conditions
-----------------
Hand Osteoarthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria: Patients with the following diseases will be excluded：Rheumatoid arthritis, Gout arthritis, Psoriatic arthropathy, Hypertrophic osteoarthropathy, Hypermotility syndrome, Hemochromatosis, Post-traumatic OA, Other secondary-form OA and Lupus. The individual is excluded if the hand X-rays show MCP changes compatible with hemochromatosis. The site then is obligated to measure fasting transferrin saturation (FE/TIBC ratio) and if >55%, the individual is excluded. Have more than 3 swollen MCP joints equal to, or greater than KL grade 2. Be unable to give informed consent. One cannot participate in this study if other members of his or her immediate family have already been recruited (Only one person from each family can participate in the study).

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 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 |
| --- | --- |
| Hand osteoarthritis<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hand Osteoarthritis related gene expression assay | The sample was collected from the patient who suffered from osteoarthritis of finger joints, espcially DIP joint. The operation was perfomed due to arthrodesis procedure. So we set the outcome measurement goal for the arthrodesis successful rate. | 4 years |
A Comparison of the ASHC and CDSMP

Study Overview
=================
Brief Summary
-----------------
The arthritis-specific Arthritis Self Help Course (ASHC) and the more generic Chronic Disease Self Management Program (CDSMP) teach generalizable skills for managing arthritis and other chronic diseases. In some locations it may be more feasible to combine efforts and offer the generic course rather than the arthritis-specific program. However anecdotal evidence has questioned whether people with arthritis obtain as much benefit from the more generic course as they do the arthritis-specific course. The primary purpose of this research study is to compare health outcomes among people with arthritis who participate in either ASHC or the CDSMP. The University of Illinois Project is emphasizing recruiting a balance of uran and rural participants. The results of this research will be used to guide Arthritis program recommendations on the use of ASHC and CDSMP to improve the quality of life for people with arthritis.

Official Title
-----------------
A Comparison of the ASHC and CDSMP

Conditions
-----------------
Arthritis

Intervention / Treatment
-----------------
* Behavioral: ASHC and CDSMP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult with self reported arthritis- Exclusion Criteria: -

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

Primary Purpose: Educational/Counseling/Training
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: ASHC and CDSMP|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health status at 6 month follow up |  |  | 
| Health Care utilization at 6 month follow up |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| self management behaviors at 6 month follow up |  |  | 
| self efficacy at 6 month follow up |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
arthritis, self management
Objective Visual Acuity Measurement Using Suppression of the Optokinetic Nystagmus (OKN).

Study Overview
=================
Brief Summary
-----------------
Suppression of the optokinetic nystagmus when a target is perceived can be applied to assess visual acuity objectively. Our aim is to establish prediction intervals for this optokinetic nystagmus suppression test (Speedwheel Test, SW) so that SW acuity may be used to estimate Snellen acuity (FrACT- C and -E) in the clinic in adults and children unable to cooperate in other acuity testing.

Detailed Description
-----------------
In this prospective single center study subjects aged at least 4 years underwent testing of visual acuity with SW, Landolt-C and Tumbling-E symbols (Freiburg acuity test: FrACT-C, FrACT-E). Prediction intervals are to be established for SW compared to FrACT-C or -E and for FrACT- E compared to FrACT-C.

Official Title
-----------------
Clinical Application of Objective Visual Acuity Measurement Using Suppression Method to Inhibit Optokinetic Nystagmus (OKN).

Conditions
-----------------
Visual Acuity

Intervention / Treatment
-----------------
* Diagnostic Test: Visual acuity testing with SW , Landolt-C and Tumbling-E symbols


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: able and willing to perform the test Exclusion Criteria: under 4 years of age unable or unwilling

Ages Eligible for Study
-----------------
Minimum Age: 4 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 |
| --- | --- |
| Human subjects aged 4 and above<br>Human volunteers aged 4 and above. | Diagnostic Test: Visual acuity testing with SW , Landolt-C and Tumbling-E symbols<br>* Establish prediction intervals for acuity tests<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction intervals of Snellen acuity for the SW | Prediction intervals of Snellen acuity for the SW compared to Landolt C and E symbols | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction intervals of Snellen acuity for Landolt C compared to E symbols | Prediction intervals of Snellen acuity for Landolt C compared to E symbols | 12 months |
Endotracheal Tube Intracuff Pressure and Leak

Study Overview
=================
Brief Summary
-----------------
We have devised a simple method to continuously measure the endotracheal tube cuff pressure (CP) using an invasive pressure monitoring setup (IPMS), which is used routinely in the operating room to monitor arterial or central venous pressures. We have previously confirmed both in vitro and in vivo (previous IRB approved protocol), a clinically applicable agreement of the IPMS readings with the values obtained from a standard manometer (gold standard). In the current study, we will prospectively evaluate the relationship between the patient's head position and CP in patients undergoing otolaryngological surgery. A secondary outcome measure is the oxygen or nitrous oxygen concentration in the oropharynx.

Official Title
-----------------
Endotracheal Tube Intracuff Pressure and Leak Around the Cuff During Retractor Placement for Tonsillectomy and/or Adenoidectomy

Conditions
-----------------
Otolaryngological Surgery

Intervention / Treatment
-----------------
* Device: Cuffed ETT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Less than 18 years of age, undergoing otolaryngological surgery with endotracheal intubation. Exclusion Criteria: Patient who is intubated with an uncuffed endotracheal tube. Patients who have a limitation for movement of the neck or concerns of the stability of the cervical spine.

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| Cuffed ETT<br>Pediatric patients intubated with a cuffed endotracheal tube for adenotonsillectomy. | Device: Cuffed ETT<br> <br> * Other names: Kimberly Clark Microcuff ETT;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the Intracuff Pressure | Changes in the intracuff pressure from baseline of cuffed ETT's after positioning of the patient's head and retractor placement. | during time of surgery |
Early Prediction of Hypocalcemia After Thyroidectomy Using Postoperative Second Hour Parathormone

Study Overview
=================
Brief Summary
-----------------
Hypocalcemia is the most frequent complication in thyroid surgeries. Diagnosing this complication earlier will reduce longer hospital stay and will lead to an earlier intervention. The purpose of the study is to evaluate postoperative second hour parathyroid hormone measurement as a predictor for early stage hypocalcemia.

Official Title
-----------------
Early Prediction of Hypocalcemia After Thyroidectomy Using Postoperative Second Hour Parathormone

Conditions
-----------------
Hypocalcemia, Postoperative Parathormone

Intervention / Treatment
-----------------
* Diagnostic Test: parathormone level


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with multinodular goiter, Graves, fine needle aspiartion biopsy with Bethesda 3-4 undergoing total thyroidectomy Exclusion Criteria: pregnant women patients with thyroid cancer or previous neck dissection

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| control-normocalcemia group<br> | Diagnostic Test: parathormone level<br>* From the patients, blood will be taken preoperatively and postoperatively.<br>* Other names: calcium level;|
| hypocalcemia group<br> | Diagnostic Test: parathormone level<br>* From the patients, blood will be taken preoperatively and postoperatively.<br>* Other names: calcium level;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative parathormone level |  | postoperative 2. hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypocalcemia, parathormone, bone density
Improving The Nutritional Status Of The Malnourished Chronic Hemodialysis Patients In The State Of Tennessee

Study Overview
=================
Brief Summary
-----------------
We propose to identify malnourished chronic kidney dialysis patients through a statewide effort and subsequently treat them based on a protocol (provision of oral nutritional supplementation) over a period of six (6) months.

Official Title
-----------------
Improving The Nutritional Status Of The Malnourished Chronic Hemodialysis Patients In The State Of Tennessee

Conditions
-----------------
End Stage Renal Disease

Intervention / Treatment
-----------------
* Dietary Supplement: Nepro nutritional supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: On CHD dialysis for more than 6 months Adequately dialyzed (Kt/V > 1.0) with a biocompatible hemodialysis membrane. Patients with Kt/V > 1.0 but < 1.4 will be evaluated for etiologies of lower than optimal dialysis dose and every effort will be made to increase the Dialysis dose to 1.4 or above. Patients with all access types will be recruited to the study. Suboptimal nutritional status identified by one of the following criteria: Protein catabolic rate less than 1.0 g/kg/d calculated by three-point urea kinetic modeling on at least 2 occasions over the past 3 months Progressive unintentional weight loss more than 2.5% of the initial or ideal body weight and/or patients who are less than 90% of ideal body weight. Biochemical parameters of malnutrition defined by one of the following measurements over the consecutive two months prior to inclusion: Serum albumin less than 4.0 g/dl Serum transferrin concentration less than 250 mg/dl Serum prealbumin concentration less than 32 mg/dl Subjective Global Assessment Score less than 5. Exclusion Criteria: Intolerance to nutritional supplementation (unable to tolerate any of the nutritional supplements available) Refusal to sign a consent form On nutritional supplementation (IDPN or PO) within 2 weeks of the study initiation.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Dietary Supplement: Nepro nutritional supplement<br>* oral nutritional supplement (Nepro); every other day, 3 days per week, for 6 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| increase in serum albumin |  | 6 months |
The Effect of Chlorella on Glycemic Control of Diabetes

Study Overview
=================
Brief Summary
-----------------
Chlorella, a type of unicellular fresh water algae, has been a popular foodstuff in Asia, especially in Taiwan. Recent studies have shown the hypoglycemic effects of Chlorella through increasing glucose uptake in the liver and muscle, lowering serum free fatty acid levels, or activation of PPAR gamma receptor. However, the hypoglycemic effect in diabetic patients have not been studied. In order to clarify the hypoglycemic effects and mechanism of Chlorella in diabetic patients, the investigators conducted a 12-week randomized, double-blind, placebo-control trial on diabetic patients.

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Drug: Chlorella


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-70 years old type 2 diabetes with less than 2 kinds of oral antidiabetes drugs Hba1c: 7.0-9.0 Exclusion Criteria: type 1 diabetes pregnancy acute infectious disease autoimmune disease hemodynamic unstable

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chlorella<br> | Drug: Chlorella<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin concentration during oral glucose tolerance test | All subjects received the first oral glucose tolerance test before intervention(week 0), and the second oral glucose tolerance test on week 12. | 12 weeks |