linjc16/ctgov huggingface dataset:
VARGADO - Vargatef in 2nd-line Therapy of Non-Small Cell Lung Cancer (NSCLC)

Study Overview
=================
Brief Summary
-----------------
This observational study will investigate the efficacy and tolerability of Vargatef (Nintedanib) plus docetaxel in daily routine second-line treatment in patients with locally advanced, metastatic or locally recurrent NSCLC. Treatment with Vargatef in eligible NSCLC patients, for whom the treating physician has decided to initiate treatment with Vargatef in second line according to the local label, will be observed for up to 24 months. Survial follow-up will be done until the end of the study.

Official Title
-----------------
Vargatef in 2nd-line Therapy of Advanced or Metastatic Adenocarcinoma of the Lung

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
-----------------
* Drug: treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: age 18 or older men and women locally advanced, metastastic and/or recurrent NSCLC with adenocarcinoma histology for which vargatef treatment is indicated according to Summary of Product Characteristics (SmPC) after first line chemotherapy. This includes also combinations of immune- and chemotherapy. standard 21-day-cycles docetaxel treatment according to SmPC possible written informed consent Exclusion criteria: contraindications according to the SmPC of Vargatef or Docetaxel more than one chemotherapy for treatment of NSCLC in palliative setting current partcipation in a clinical trial pregnancy breastfeeding

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 |
| --- | --- |
| A<br> | Drug: treatment<br>* Docetaxel plus nintedanib until progression or intolerability<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients alive one year after start of therapy with Vargatef and Docetaxel (1-year survival rate) |  | up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| One year survival rate of patients with first line progression within 9 months after start of first line therapy |  | up to 24 months | 
| Progression-free survival of patients with first line progression within 9 months after start of first line therapy |  | up to 24 months | 
| Median overall survival |  | up to 24 months | 
| Progression-free survival |  | up to 24 months | 
| Tumour control rate (complete response, partial response, stable disease) |  | up to 24 months | 
| Incidence of side effects |  | up to 24 months |
Performance of CAST (Cellular Antigen Stimulation Test) in Patients With Wasp Venom Allergy: Evaluation of Neutralizing IgG Subclasses

Study Overview
=================
Brief Summary
-----------------
To determine which subclass of IgG in the serum of patients undergoing SIT against wasp venom is able to neutralize the allergen, and therefore to prevent a positive CAST

Official Title
-----------------
Performance of CAST (Cellular Antigen Stiumulation Test)in Patients With Wasp Venom Allergy. Evaluation of Neutralizing IgG Subclasses

Conditions
-----------------
Wasp Venom Allergic Patients

Intervention / Treatment
-----------------
* Other: Taking blood samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: male and female patient with allergy to wasp venom grade III and IV according to H.L. Müller 18-75 years planned SIT against wasp venom or finished 5 years SIT against wsp venom (10/10) Exclusion criteria: oral corticosteroids chromogycin ketotifen immunosuppressive drugs within the last 2 years

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Hymenoptera allergic patients before allergen specific immunotherapy | Other: Taking blood samples<br>* No intervention is done. Only blood samples are taken.<br>|
| 2<br>Hymenoptera allergic patients after allergen specific immunotherapy | Other: Taking blood samples<br>* No intervention is done. Only blood samples are taken.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Effect of Systemic Dietary Instruction on Management of Plasma Phosphorus Levels in Peritoneal Dialysis (PD) Patients

Study Overview
=================
Brief Summary
-----------------
Hyperphosphatemia is highly prevalent in PD patients, and it is an independent risk factor for all-cause and cardiovascular mortality in these patients. Effective treatments are limited in suppressing plasma phosphorous. Because of the nearly linear relationship between protein and phosphorus intake, high dietary protein intake (DPI, 1.2-1.3g/kg/d recommended by KDOQI) would load high phosphorus burden in PD patients. It is suggested that hyperphosphatemia is hard to avoid under such a DPI level, even as the patients take sufficient phosphorus blinders and receive high PD dosage. The present study is to investigate whether systemic dietary instruction would show effects on control of hyperphosphatemia in PD patients.

Conditions
-----------------
Hyperphosphatemia

Intervention / Treatment
-----------------
* Other: systemic dietary instruction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable on PD for at least three month Aged from 18 to 75 years old Informed consent approval Exclusion Criteria: Malnutrition (based on SGA results) Infection or inflammation within 1 month Concurrent wasting disease (i.e. cancer, tuberculosis)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: interventional group<br> | Other: systemic dietary instruction<br>* systemic dietary instruction based on continuous quality improvement (CQI) team-oriented approach<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma phosphorus levels |  | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma calcium levels |  | up to one year | 
| Carotid artery intima-media thicknesses |  | up to 1 year | 
| Plasma albumin levels |  | up to 1 year |
Effects of a Telerehabilitation Approach in Children With Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
Patients with cystic fibrosis aged 6-13 will be recruited and randomized into two groups: one will receive telerehabilitation sessions including postural, breathing and high-intensity interval training exercises and one will be subject to routine follow up. Exercise program will be applied three days a week for three months. Children will be assessed by pulmonary function tests, cystic fibrosis quality of life questionnaire, six minute walking test and anxiety and depression scale in children, while caregivers will be assessed by Beck depression scale and situational anxiety inventory.

Official Title
-----------------
The Effect of Telerehabilitation on Quality of Life, Anxiety and Depression Levels in Children With Cystic Fibrosis and Their Caregivers

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Other: Telerehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diagnosed cystic fibrosis Exclusion Criteria: Current pulmonary exacerbation Musculoskeletal problems hinder exercising No internet access Patients and parents do not consent to intervention

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 13 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise group<br>Patients in this group will attend telerehabilitation sessions. | Other: Telerehabilitation<br>* Patients will attend rehabilitation sessions through online programmes for rehabilitation<br>|
| No Intervention: Control group<br>Patients in this arm will be subject to routine follow up. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cystic fibrosis quality of life questtionaire | Cystic fibrosis quality of life questtionaire | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anxiety, depression, cystic fibrosis, caregiver, telerehabilitation
Physical Activity and Cardiovascular Risk in Black Girls

Study Overview
=================
Brief Summary
-----------------
To conduct a longitudinal study investigating the physical activity patterns, the psychosocial predictors of physical activity, and the effects of physical activity changes on blood pressure and body fatness in a cohort of African-American girls, ages 11-17.

Detailed Description
-----------------
BACKGROUND: The study contributed to an underdeveloped area of research. Physical activity is recommended as a nonpharmacological means to modify hypertension and obesity, two cardiovascular risk factors. African-American women have low levels of physical activity and high rates of obesity, hypertension, and mortality from coronary heart disease, diabetes, and hypertensive diseases. In 1992, there was an absence of longitudinal data about the physical activity habits of African-American girls even though a decline in physical activity during adolescence had been reported in other subpopulations. DESIGN NARRATIVE: Within the framework of puberty and maturation, the study: 1) described longitudinal patterns of physical activity; 2) assessed longitudinal changes in physical activity and concomitant changes in blood pressure and body fatness; and 3) determined psychosocial predictors of changes in physical activity. The investigators hypothesized that there would be a monotonic decrease in physical activity and that psychosocial variables would predict changes in physical activity. The study population consisted of 189 sixth grade, mostly African-American, girls in Fort Bend Independent School District, Missouri City, Texas. The girls were measured for four and a half years, ages 11 or 12 at entry of the study. Anthropometry, sexual maturation, blood pressure, physical activity habits and psychosocial predictors were measured twice a year for a total of nine examinations. Data on dietary, smoking and drinking habits were collected annually. Activity patterns, psychosocial predictors and other habits were assessed by interviews and questionnaires. Sexual maturation was assessed by menarche and the Tanner stages. Skinfold and circumference measures determined body fatness and body fat distribution.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Hypertension, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 17 Years

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

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 |
| --- | --- | --- |
Eustachian Tube Testing in a Pressure Chamber -- Validation Study

Study Overview
=================
Brief Summary
-----------------
This study will compare Eustachian tube function (ETF) testing in adults with intact tympanic membranes (TM) using a pressure chamber to that obtained using standard methods requiring a non-intact TM.

Detailed Description
-----------------
The investigators propose to introduce new test methods and protocols to our laboratory for better clinical characterization of Eustachian tube function in ears with intact TM's. These test will be done in a pressure-chamber and will use previously published and newly developed methods. Participation will require a minimum of 5 visits to the ENT Research Center, 1 for myringotomy (putting a small hole in the eardrum) and 4 for ETF testing. Hearing testing will be done at entry and exit; otoscopy (looking at the ears) and tympanometry (a test done with an earplug and varying pressures in the ear canal) are done at every visit.

Official Title
-----------------
Eustachian Tube Testing in a Pressure Chamber -- Validation

Conditions
-----------------
Otitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 years old Normal middle-ear status Exclusion Criteria: Chronic illness including asthma, pulmonary, or cardiac problems Pregnancy >10 dB hearing loss in any of the speech frequencies Past history of sensitivity or allergic reaction to lidocaine or related compounds

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 |
| --- | --- |
| 1<br>Healthy adult volunteers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eustachian tube function testing results |  | up to 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
otitis, Eustachian tube function, Normal middle ear status
Oxandrolone Compared With a Placebo on Growth Rate in Girls With Growth Hormone-Treated Turner's Syndrome

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Turner's syndrome is a disease in which females are missing all or part of one X chromosome and do not produce the hormones estrogen and androgen. Giving growth hormone may help girls with Turner's syndrome attain a more normal height. It is not yet known if growth hormone is more effective with or without oxandrolone for Turner's syndrome. PURPOSE: Randomized phase II trial to study the effectiveness of oxandrolone in girls who have growth hormone-treated Turner's syndrome.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized study. Patients are randomly assigned to recombinant human growth hormone (GH) and oxandrolone versus GH and placebo. GH is administered by daily subcutaneous injection and oxandrolone is given every day by mouth. Treatment continues for 3 years; estrogen is offered after year 2. A study duration of 8 years is anticipated.

Official Title
-----------------
Phase II Randomized Study of Oxandrolone vs Placebo for Growth Hormone-Treated Girls With Turner's Syndrome

Conditions
-----------------
Turner's Syndrome

Intervention / Treatment
-----------------
* Drug: growth hormone
* Drug: oxandrolone


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: Turner's syndrome-compatible karyotype No Y material in peripheral karyotype Bone age no greater than 11 years --Prior/Concurrent Therapy-- No more than 12 months of prior estrogen, androgen, or growth hormone

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 14 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: growth hormone|nan|
|Drug: oxandrolone|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
-----------------
rare disease, Turner's syndrome, genetic diseases and dysmorphic syndromes
Oral Low-molecular Weight Hyaluronic Acid in the Treatment of Atrophic Vaginitis

Study Overview
=================
Brief Summary
-----------------
To evaluate the effectiveness of low molecular weight hyaluronic acid oral tablets for the treatment of atrophic vaginitis.

Conditions
-----------------
Atrophic Vaginitis

Intervention / Treatment
-----------------
* Dietary Supplement: Hyaluronic acid
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 12 months postmenopausal mucosal atrophy and the main bothersome related symptoms, such as itching, burning, and dyspareunia.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyaluronic acid<br>220 mg hyaluronic acid per tablet (two tablets/day for 10 days, and subsequently one tablet/day for three months) | Dietary Supplement: Hyaluronic acid<br> <br> |
| Placebo Comparator: Placebo<br>two tablets/day for 10 days, and subsequently one tablet/day for three months | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrophic vaginal changes | Morphometric analysis of biopsies. | Change from baseline epithelium at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Itching | Scale: absent, mild, moderate, severe. | Change from baseline Itching at 3 months | 
| Assessment of Burning | Scale: absent, mild, moderate, severe. | Change from baseline Burning at 3 months | 
| Assessment of Dyspareunia | Scale: absent, mild, moderate, severe. | Change from baseline Dyspareunia at 3 months |
Changes in Quality of Life Following Surgical Treatment of Benign Non-toxic Goiter

Study Overview
=================
Brief Summary
-----------------
The aim is to investigate the influence of surgical treatment on benign non-toxic goiter on the disease specific quality of life evaluated 6 months after thyroid surgery. All investigations follow already scheduled treatments.

Official Title
-----------------
The Impact of Surgical Treatment of Benign Non-toxic Goiter on Quality of Life

Conditions
-----------------
Goiter

Intervention / Treatment
-----------------
* Procedure: Thyroidectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing hemi- or total thyroidectomy for benign non-toxic goiter with pressure symptoms The patients must be able to understand, read and write Danish Exclusion Criteria: Previous surgery to the neck Diabetes or any neuromuscular disorders Present or previous head and neck malignancy, including malignancy found in the surgical thyroid specimen or suspicion hereof

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Thyroidectomy|Regular thyroidectomy or hemithyroidectomy through Kocher's skin incision|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life following thyroidectomy | Change in goiter symptom score at the Thyroid specific Patient Reported Outcome measure (ThyPRO) following thyroidectomy | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Goiter, Thyroid disease, Struma