linjc16/ctgov huggingface dataset:
Long Term Follow up Study of Predictive Markers in GHD and TS Children

Study Overview
=================
Brief Summary
-----------------
Primary objective is to assess the relationship between changes from serum biomarkers observed after 1 month of Saizen® therapy and change in height, weight after up to 5 years of treatment with Growth Hormone in children with Growth Hormone Deficiency (GHD) and Turner Syndrome (TS).

Detailed Description
-----------------
This study is an observational study that will collect data from patients enrolled in a previous study (PREDICT, NCT 00256126). Data such as auxological parameters (height, weight, Tanner stage, bone age will be collected as well as GH treatment use (including dose and adherence to the treatment). Because for some countries the start of this long term follow up study will take place more than one year after subjects have completed the initial study (PREDICT) retrospective data may be collected (if subjects agree) as well as prospective data. When available laboratory parameters such as IGF-1, IGFPB-3, fasting glucose, fasting insulin, TSH and T4 will also be collected. This data will be collected yearly during the normal follow up visits during 5 years.

Official Title
-----------------
Observational Long-term Follow-up of the Phase IV Open-label Trial of Predictive Markers in GHD and TS Pre-pubertal Children Treated With Saizen

Conditions
-----------------
Growth Hormon Deficiency, Turner Syndrome in Pre-pubertal Children

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have completed the PREDICT study (NCT 00256126) Followed up at least 1 year when still under treatment after completion of PREDICT Trial Parent's or guardian's written consent given before any data collection Exclusion Criteria: Use of an investigational drug or participation in another interventional clinical trial since discontinuation of PREDICT trial
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 |
| --- | --- | --- |
| Data such as auxological parameters (height, weight, Tanner stage, bone age) will be collected as well as GH treatment use (including dose and adherence to the treatment). |  | Yearly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| When available laboratory parameters such as IGF-1, IGFPB-3, fasting glucose, fasting insulin, TSH and T4 will also be collected. |  | Yearly | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Growth Hormon Deficiency and, Turner Syndrome in pre-pubertal children, Long term follow-up of predictive markers
Safety and Bioefficacy of Vitamin D2 and Vitamin D3

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the bioavailability of vitamin D2 and D3 as measured by the increase of the specific hydroxy forms in serum (25(OH)D2 and 25(OH)D3, respectively, and by total 25(OH)D.

Detailed Description
-----------------
Study design: Human volunteers will receive supplements containing either vitamin D2 or D3 for a period of 8 weeks. At baseline, after 4 weeks and after 8 weeks, 25(OH)D2, 25(OH)D3 and total 25(OH)D will be measured in serum as the main outcome variables. Additional outcome variables are the Ca concentration in serum, PTH concentration in serum, ambulatory blood pressure and heart rate, and renin expression in peripheral mononuclear cells. Groups/Cohorts Assigned Interventions Placebo group Vitamin D2-group Daily treatment with vitamin d2-supplements (containing 2000 IU per capsule) Vitamin D3-group Daily treatment with vitamin d3-supplements (containing 2000 IU per capsule)

Official Title
-----------------
Safety and Bioefficacy of Vitamin D2 and Vitamin D3: Randomized Trial With Human Volunteers

Conditions
-----------------
Vitamin D Deficiency

Intervention / Treatment
-----------------
* Dietary Supplement: cholecalciferol
* Dietary Supplement: ergocalciferol
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years healthy Exclusion Criteria: supplementation of vitamin d and calcium hypercalcemia hypercalciuria chronical illness (diabetes, kidney diseases, cardiovascular diseases) serum-creatinine above 115 mmol/l pregnancy or breastfeeding women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cholecalciferol<br>Human volunteers receiving cholecalciferol (vitamin D3) for 8 weeks | Dietary Supplement: cholecalciferol<br>* cholecalciferol, 2000 IU per day, 8 weeks<br>* Other names: Cholecalciferol, vitamin D3;|
| Experimental: Ergocalciferol<br>Ergocalciferol 2000 IU per day for 8 weeks | Dietary Supplement: ergocalciferol<br>* vitamin d2, 2000 IU per day for 8 weeks<br>|
| Placebo Comparator: Placebo<br>Placebo for 8 weeks | Dietary Supplement: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of 25-hydroxvitamin D |  | after 4 and 8 weeks of supplementation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
randomized controlled trial, vitamin D, bioavailability
Hormonal Replacement Therapy and Small Artery Function

Study Overview
=================
Brief Summary
-----------------
Endothelial dysfunction in resistance arteries in women after the menopause is important for the development of high blood pressure and cardiovascular disease

Detailed Description
-----------------
We aim to study the effects of different hormone replacement therapies (HRT) on the function and morphology of resistance arteries, and to look for their mechanistic basis. We expect that HRT with estrogens or in combination with MPA may benefit the function of resistance arteries and may preserve the morphological integrity of endothelial cells by regulatory actions on the cytoskeleton.

Official Title
-----------------
Hormonal Replacement Therapy and Small Artery Function

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

Intervention / Treatment
-----------------
* Drug: Femanest
* Drug: gestapuran
* Drug: placebo
* Drug: Femanest plus Gestapuran


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All women had been amenorrheic for at least 1.5 year. Menopausal status was confirmed by a serum concentration of follicular- stimulating hormone (FSH > 34 IU/ml) and estradiol (E2 <50 pmol/l). Exclusion Criteria: Cigarette smokers and women with: Hypertension Diabetes mellitus Clinical manifestations of arteriosclerosis (coronary heart disease, peripheral artery disease, or cerebrovascular disease) Venous thromboembolic disease Liver disorders Unexplained vaginal bleeding; and Personal or family history of breast cancer were excluded.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 60 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: placebo<br>* daily<br>|
| Experimental: 2<br> | Drug: Femanest<br>* 2mg/day<br>|
| Experimental: 3<br> | Drug: gestapuran<br>* 5mg/day<br>|
| Experimental: 4<br> | Drug: Femanest plus Gestapuran<br>* combined daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endothelium-dependent dilatation |  | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pressure-induced tone and vascular morphology |  | 3 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hormone replacement therapy; endothelial function;
Biomarker Study of Pancreatic Neuroendocrine Tumours

Study Overview
=================
Brief Summary
-----------------
The biology of pancreatic neuroendocrine tumors can change during the disease course. This evolution of disease can manifest through increases in tumor proliferation rate, resistance to medical therapy and/or a change in tumor hormone secretion. This study aims to characterize how the biology of pancreatic neuroendocrine tumors change over time, measured by; patient symptoms, biochemistry, contrast enhanced computed tomography, DOTATOC-PET, FDG-PET and core needle biopsy with histopathological analysis (Ki67 index and tumor cell differentiation). Uptake on 68Ga-DOTATOC and 18F-FDG-PET will be correlated directly to tumor cell proliferation rate. Fraction of patients with spatial heterogeneity in DOTATOC as well as FDG uptake as well as metachronous changes in all collected data will be documented. Biomaterial from whole blood and core needle biopsies will be characterized on the molecular level, and those findings will be integrated to the above specified clinical parameters.

Official Title
-----------------
Prospective Longitudinal Observation Trial of Clinical and Molecular Features of Pancreatic Neuroendocrine Tumours

Conditions
-----------------
Pancreatic Neuroendocrine Tumor

Intervention / Treatment
-----------------
* Radiation: 18F-FDG-PET
* Radiation: 68Ga-DOTATOC-PET
* Radiation: Computed tomography
* Other: Core needle biopsy
* Other: Phlebotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years Informed consent Pathology confirmed diagnosis of pancreatic neuroendocrine tumor WHO grade 1-3 or neuroendocrine carcinoma grade 3. Exclusion Criteria: Patient does not consent Pregnancy or no contraceptive in fertile women.

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

| Intervention/Treatment |
| --- |
|Radiation: 18F-FDG-PET|Fludeoxyglucose F18|
|Radiation: 68Ga-DOTATOC-PET|DOTA-tyr3-Octreotide Ga68|
|Radiation: Computed tomography|Computed tomography of thorax and abdomen with 3-phase contrast|
|Other: Core needle biopsy|Core needle biopsy of metastatic lesions|
|Other: Phlebotomy|Phlebotomy from peripheral vein|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protocol adherence | Defined as the proportion of patients where that following investigations are performed: Core needle biopsy, FDG-PET, DOTATOC-PET, research blood samples, pancreatic hormones and hormonal syndromes. | Study inclusion |
A Trial to Evaluate Epothilone D in Patients With Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
Epothilone D represents one of a class of cytotoxic macrolides capable of causing mitotic arrest by stabilizing tubulin polymerization. Since microtubules are essential for mitosis, motility, secretion and proliferation, the observed antitumor effects of epothilones have been attributed to their ability to initiate cell death by inhibiting such processes. Epothilone D has demonstrated in vitro cytotoxic activity in a panel of human cell lines, equipotent to that of paclitaxel. In vivo, Epothilone D has also shown significant antitumor activity in a range of xenograft models, including paclitaxel-resistant xenografts. Epothilone D is more potent than paclitaxel in cell lines that demonstrate multiple drug resistant activity overexpressing p-glycoprotein.

Official Title
-----------------
A Phase 1, Dose Escalation Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Epothilone D in Patients With Advanced Solid Tumors

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Drug: Epothilone D (KOS-862)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of histologically documented, advanced stage, primary or metastatic adult solid tumors that are refractory to standard therapy or for which no curative standard therapy exists. This includes but is not limited to cancers of the breast, ovary, head and neck, esophagus, lung, gastrointestinal tract, and sarcomas. Evidence of radiographically measurable or evaluable disease. Exclusion Criteria: Pre-existing peripheral neuropathy of CTC Grade > 2 due to any cause. Documented hypersensitivity reaction (CTC Grade > 2) to prior paclitaxel or other therapy containing Cremophor.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Epothilone D (KOS-862)|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
-----------------
Epothilone D, tubulin polymerization
Physician-Nurse and Nurse-Nurse Collaboration

Study Overview
=================
Brief Summary
-----------------
This study was carried out to determine the level of collaboration and the factors affecting its between physicians-nurses and nurses-nurses working in different hospitals.

Detailed Description
-----------------
Collaboration is a broad concept with different definitions in the literature. Researches on physician-nurse collaboration and nurse-nurse collaboration has shown that improves the quality of patient care; reduces the medical errors; affects the job satisfaction positively and decreases the intention to quit in the international literature. In the light of this information, the study was planned to determine the level of collaboration and the factors affecting its between physicians-nurses and nurses-nurses working in different hospitals. Research is a cross-sectional study. The study is planned the 500 nurses working in six hospitals in Ordu/Turkey on January 3-12 February 2019. Descriptive questionnaire form, Jefferson Scale of Physician-Nurse Collaboration (JSAPNC) and nurse-nurse collaboration scale will be used in the study.

Official Title
-----------------
Physician-Nurse and Nurse-Nurse Collaboration in Different Hospitals: An Example From Turkey

Conditions
-----------------
Nurse

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: nurse working experiences at least 6 months working full time. Exclusion Criteria working experiences less than 6 months head-nurses
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 |
| --- | --- | --- |
| Descriptive questionnaire form, | Descriptive questionnaire form includes nurse's age, gender, education, clinical experiences and hospital types etc. | 2 minutes | 
| Jefferson Scale of Physician-Nurse Collaboration | The scale includes 15 question about physician and nurse collaboration. | 3 minutes | 
| nurse-nurse collaboration scale | The scale includes 35 question about nurse and nurse collaboration. | 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
physician-nurse collaboration, nurse-nurse collaboration
Nutritional Study in Preterm Infants

Study Overview
=================
Brief Summary
-----------------
An evaluation of a preterm infant formula containing ingredients similar to those found in breastmilk

Official Title
-----------------
Effect of Supplemental Infant Formula on Blood Levels in Preterm Infants

Conditions
-----------------
Preterm Infants

Intervention / Treatment
-----------------
* Other: Preterm infant formulas and discharge formulas
* Other: Preterm infant formula with added soluble lipids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Birthweight 500-1800 g Less than 33 wks gestational age Enteral feeding initiated by 21 days of life Asymmetrical small-for-gestational age (SGA) infants and infants with patent ductus arteriosus (PDA) are eligible to participate Singleton or twin births only Infant is 21 days of age or less at time of randomization Exclusion Criteria: Serious congenital abnormalities that may affect growth and development Grade III or IV intraventricular hemorrhage (IVH) Maternal incapacity History of major surgery Extracorporeal membrane oxygenation (ECMO) Asphyxia Confirmed NEC or positive blood cultures at the time of randomization

Ages Eligible for Study
-----------------
Maximum Age: 21 Days

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infant Formula<br>Preterm infant formulas containing lipid soluble compounds | Other: Preterm infant formula with added soluble lipids<br>* Preterm infant formula to be fed per healthcare provider instructions<br>|
| Active Comparator: Preterm formulas<br>Standard preterm infant formula and discharge formulas | Other: Preterm infant formulas and discharge formulas<br>* Preterm infant formulas to be consumed per health care provider orders<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this study is to compare the serum concentrations of fat soluble compounds in preterm infants fed a regimen of preterm formulas and in human milk fed infants |  | variable | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measures of eye function, ROP, measures of skin lipid soluble compound concentration |  | variable |
Relationship Between Evolution of Resting Energy Expenditure and Tumoral Response to Chemotherapy in Patients Suffering From Pancreas Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether evolution of resting energetic expenditure is a predictive marker of tumoral response for patients suffering from metastatic pancreatic cancer and treated with 1st line of chemotherapy.

Official Title
-----------------
Monocentric, Prospective Study Assessing the Feasibility to Use Resting Energy Expenditure by Indirect Calorimetry as Prognostic Marker of Tumoral Response to 1st Line Chemotherapy in Patients Suffering From Metastatic Pancreatic Cancer

Conditions
-----------------
Metastatic Pancreatic Cancer

Intervention / Treatment
-----------------
* Other: Measure of resting energetic expenditure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pancreatic metastatic cancer Patient older than 18 years Initiation of a first line of chemotherapy by Folfirinox, or Gemcitabine or in combination with Nab-Paclitaxel. At least one measurable target lesion Patient signed consent for Energie-Pancreas study participation Exclusion Criteria: Other concomitant cancer Major general status alteration ( Performance status = 3 or 4 at inclusion) Concomitant diseases explaining an altered general status or having an impact on energetic expenditure (i.e.chronic or severe infection, severe cardiac insufficiency, severe respiratory insufficiency, chronic inflammatory disease, recent surgery (< 1 month), ongoing Healing, hyperthyroidism. Smoker Patient deprived of his liberty, under guardianship, curator. Pregnant patient or breastfeeding Claustrophobic patient

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: energetic expenditure measure<br>To a standard treatment by chemotherapy, energetic expenditure will be measured 5 times during the study. | Other: Measure of resting energetic expenditure<br>* measure of resting energetic expenditure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resting energetic expenditure measurement by indirect calorimetry | Unit measure : calorie per day | 4 months | 

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