linjc16/ctgov huggingface dataset:
Effects of Hydrocortisone on Social Cognition and Memory

Study Overview
=================
Brief Summary
-----------------
The effects of hydrocortisone on cognition will be investigated.

Detailed Description
-----------------
80 healthy young individuals (40 females and 40 male) will be recruited an randomized to either placebo or 10 mg hydrocortisone before testing. Tasks will on emotion recognition, memory and cognitive flexibilty will be conducted.

Official Title
-----------------
Effekte Von Hydrocortison Auf Soziale Kognition Und Gedächtnis Unter Berücksichtigung Von Geschlechtereffekten

Conditions
-----------------
Individuality

Intervention / Treatment
-----------------
* Other: Hydrocortisone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 - 30 medication free Exclusion Criteria: any medication severe ilness

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydrocortisone<br>10 mg hydrocortisone | Other: Hydrocortisone<br>* Effects of hydrocortisone compared to placebo on cognition<br>|
| Placebo Comparator: Placebo<br>1 pill Placebo | Other: Hydrocortisone<br>* Effects of hydrocortisone compared to placebo on cognition<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| social cognition | computer based test: Multifaceted Empaty test | 25 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| memory | autobiographic memory test (AMT) | 25 min | 
| cognitive flexibilty | computer based test: task switch | 10 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
effects of cortisol on cognition
Endoscopic Ultrasound (EUS) Guided Fine Needle Aspiration (FNA) EUS-FNA of Solid Pancreatic Mass Lesions Using a Novel Corkscrew Technique: a Pilot Study

Study Overview
=================
Brief Summary
-----------------
This research is being done to investigate if a new technique to biopsy the pancreas will lead to a larger amount tissue material that can be analyzed. Investigators have called the technique the corkscrew technique and believe it will allow obtaining a larger biopsy sample during the endoscopic ultrasound examination. The corkscrew technique uses a clockwise rotational movement to drive the needle into the pancreatic mass (like a wine bottle opener twists and buries itself into a cork). It is believed that this will lead to a better biopsy sample than the usual way and therefore result in a higher chance of a diagnosis.

Official Title
-----------------
EUS-guided Fine Needle Tissue Acquisition of Solid Pancreatic Mass Lesions Using a Novel Corkscrew Technique: a Pilot Study

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

Intervention / Treatment
-----------------
* Procedure: EUS-FNA with Corkscrew technique
* Device: Expect 19 G Flex needle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In-patients and out-patients between the age of 18 and 90 years with solid pancreatic masses presenting for EUS-Fine Needle Aspiration (FNTA) Exclusion Criteria: Uncorrectable coagulopathy (INR > 1.5) Uncorrectable thrombocytopenia (platelet < 50,000) Uncooperative patients Pregnant women (women of childbearing age will undergo urine pregnancy testing, which is routine for all endoscopic procedures) Refusal to consent form Prior negative FNTA In situ metallic biliary stents Predominantly cystic lesions Inaccessible lesions to EUS

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pancreatic mass<br>Patients with pancreatic mass presenting for EUS-FNA | Procedure: EUS-FNA with Corkscrew technique<br> <br> Device: Expect 19 G Flex needle<br> <br> * Other names: Expect 19G Flex needle; Boston scientific;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events as a Measure of Safety |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Yield of the FNA Using Corkscrew Technique | Diagnostic yield was defined as the proportion of masses in which the amount of FNA-obtained cellular material was enough for the histopathologist to make the pathological diagnosis. | 30 days |
Purified Rabies Vaccine for Human Use (Chick-embryo Cell)

Study Overview
=================
Brief Summary
-----------------
Evaluate the immunogenicity and safety of rabies vaccine given in a post-exposure prophylaxis regimen to healthy children and adults aged 10-60 years.

Official Title
-----------------
Evaluate the Immunogenicity and Safety of Rabies Vaccine Given in a Post-exposure Prophylaxis Regimen to Healthy Children and Adults Aged 10-60 Years.

Conditions
-----------------
Rabies Post-exposure Prophylaxis

Intervention / Treatment
-----------------
* Biological: rabies vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male and female healthy subjects aged 10-60 years old Exclusion Criteria: history of rabies immunization previous exposure to a suspect rabid animal within the last 12 months any significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the past 7 days treatment with corticosteroids, immunosuppressive or anti-malaria drugs during the two month period before enrollment known/suspected immunodeficiency, or autoimmune disease, or any immunologic disorder known hypersensitivity to neomycin, tetracycline, amphotericin-B, or any other vaccine component

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 60 Years

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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br> | Biological: rabies vaccine<br>* Administration of PCECV according to ESSEN regimen<br>|
| Active Comparator: Group 2<br> | Biological: rabies vaccine<br>* Administration of PCECV according to ESSEN regimen<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum bactericidal activity |  | measured at day 14 and day 45 after first vaccination dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| solicited local and systemic reactions |  | within 6 days following vaccination and adverse events thought the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rabies, vaccine, post-exposure prophylaxis
Letrozole in Metastatic Breast Cancer in Combination With Chemotherapy

Study Overview
=================
Brief Summary
-----------------
Therapeutic interventions for patients with metastatic breast cancer are aimed at prolonging survival and improving the quality of life. The objective of this trial is to assess if an initial chemotherapy followed by an endocrine therapy leads to a longer disease-free interval as compared to chemotherapy alone.

Official Title
-----------------
A Study of Letrozole in the Treatment of Metastatic Breast Cancer in Combination With Chemotherapy

Conditions
-----------------
Metastatic Breast Cancer

Intervention / Treatment
-----------------
* Drug: Letrozole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Histologically proven metastatic breast cancer Measurable disease, patients with bone only disease are not eligible Age ≥ 65 years Performance status ≤ 2 (World Health Organization) Estimated life expectancy under therapy of at least 3 months Estrogen-/progesterone-receptor status positive or unknown Signed informed consent Exclusion criteria Prior chemo- or hormone therapy for metastatic breast cancer; prior therapy with aromatase inhibitors in the adjuvant setting Disease-free interval after adjuvant therapy < 1 year Clinical signs of central nervous system metastases Renal, bone marrow, or liver insufficiency Severe coronary heart disease, cardiac insufficiency or other severe concomitant internal diseases Pulmonary fibrosis/alveolitis Additional protocol-defined inclusion/exclusion criteria may apply.

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

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

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: Letrozole|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (complete remission, partial remission,no change, progressive disease) by clinical palpation and radiologic imaging every 3 months until disease progression |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression and safety and toxicity during treatment |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metastatic breast cancer, Aromatase inhibitor, Letrozole
Effect of Vitamin D Treatment in Primary Hyperparathyroidism

Study Overview
=================
Brief Summary
-----------------
The primary aim of the study is to assess whether 6-months of vitamin D supplements can decrease PTH compared with placebo treatment in primary hyperparathyroidism.

Detailed Description
-----------------
The study investigates effects and safety of six months of vitamin D supplementation before and after surgery in primary hyperparathyroidism. Effects are assessed as changes in calcium homeostasis, bone metabolism, quality of life, and muscle strength and function.

Official Title
-----------------
Effect of Vitamin D Treatment in Primary Hyperparathyroidism

Conditions
-----------------
Vitamin D Deficiency, Primary Hyperparathyroidism, Hypercalcemia

Intervention / Treatment
-----------------
* Drug: Cholecalciferol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: P-Ca-ion > 1,30 mmol/l P-PTH > 5 pmol/l P-OH25-vitamin D < 80 nmol/l Exclusion Criteria: P-creatinin > 120 mumol/l usage of Etalpha, Mimpara Cancer Sarcoidosis malabsorption pancreatitis alcohol abuse pregnancy

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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D group<br>Cholecalciferol 1400 IU, 2 tablets once daily in 52 weeks | Drug: Cholecalciferol<br>* 2800 IE daily in 52 weeks<br>* Other names: vitamin D;|
| Placebo Comparator: Placebo group<br>Placebo, two tablets daily in 52 weeks. | Drug: Cholecalciferol<br>* 2800 IE daily in 52 weeks<br>* Other names: vitamin D;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in Preoperative P-PTH | Decrease in plasma PTH after 25 weeks of preoperative vitamin D treatment compared with the plasebo Group. | 25 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved Muscular Function |  | One Year | 
| Reduced Postoperative Hypocalcemia |  | Postoperative week | 
| Increase in Quality of Life |  | One year | 
| Increased Bone Mineral Density |  | One year | 
| Increase in Trabecular and Cortical vBMD Measured by QCT and pQCT of Hip, Spine and Forearm |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin D, Primary hyperparathyroidism, hypercalcemia
Mountain Hiking & Environmental Influences

Study Overview
=================
Brief Summary
-----------------
In a randomized crossover design, approximately 50 healthy participants will be randomly exposed to outdoor mountain hiking (approximately 6 hours each) in two different areas: an anthropogenically influenced area and in a widely pristine area.

Official Title
-----------------
Effects of Mountain Hiking on Physiological and Psychological Health Parameters With Special Focus on the Influence of the Environment

Conditions
-----------------
Healthy Participants

Intervention / Treatment
-----------------
* Behavioral: Mountain hiking


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: voluntary participation Exclusion Criteria: pregnancy breastfeeding chronic or acute diseases (already existing or diagnosed during the study) unable to be physically active assessed by the Physical Activity Readiness Questionnaire

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Widely pristine area<br>Outdoor mountain hiking (approximately 6 hours, 8km, 800 altitude meters, estimated speed: 4km/h [uphill], 5.2km/h [downhill]) in a widely pristine area with moderate intensity (Rating of perceived exertion:   11-15). | Behavioral: Mountain hiking<br>* Compare arm description<br>* Other names: Walking;|
| Active Comparator: Anthropogenically influenced area<br>Outdoor mountain hiking (approximately 6 hours, 8km, 800 altitude meters, estimated speed: 4km/h [uphill], 5.2km/h [downhill]) in an anthropogenically influenced area with moderate intensity (Rating of perceived exertion:   11-15). All characteristics of the hiking (duration, time, difference in altitude, ...) are planned to be comparable to the experimental condition except the area. | Behavioral: Mountain hiking<br>* Compare arm description<br>* Other names: Walking;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Cortisol (Saliva Sampling) at 6 hours | Physiological response | 6 hours | 
| Change from baseline subscales of mood survey scale at 6 hours | Psychological response | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline blood pressure at 6 hours |  | 6 hours | 
| Change from baseline lung function at 6 hours |  | 6 hours | 
| Change from baseline respiratory gas analysis at 6 hours |  | 6 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
affective responses, stress-related parameters, green exercise
Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion in Nigeria

Study Overview
=================
Brief Summary
-----------------
Women diagnosed with incomplete abortion in this health facility will be randomized to receive one of the following regimens: 400 mcg sublingual misoprostol in one dose or standard surgical treatment (MVA). The investigators hypothesize that treatment of incomplete abortion with misoprostol using 400 mcg administered sublingually will be as effective as surgical evacuation.

Official Title
-----------------
Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion

Conditions
-----------------
Incomplete Abortion

Intervention / Treatment
-----------------
* Drug: Misoprostol
* Procedure: surgery Manual vacuum aspiration (MVA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: no contraindications to misoprostol uterine size was not larger than 12 weeks there were no signs of severe infection haemodynamically stable in general good health willing to provide contact information Exclusion Criteria: an IUD in place ectopic pregnancy aged below 18 years and had no accompanying adult to provide informed consent

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

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

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 |
| --- | --- |
| Active Comparator: Misoprostol<br>400 mcg of sublingual misoprostol in one dose | Drug: Misoprostol<br>* single dose of 400 mcg misoprostol administered sublingually<br>|
| Active Comparator: Manual vacuum aspiration (MVA)<br>Standard surgical treatment (MVA) | Procedure: surgery Manual vacuum aspiration (MVA)<br>* standard surgical treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete abortion without recourse to surgical intervention |  | follow up visit 7 days after initial treatment |
Characterization of Local and Systemic Bone Markers in Diabetes Patients With Charcot Osteoarthropathy

Study Overview
=================
Brief Summary
-----------------
The study is designed to investigate biomarkers related to bone turnover in diabetics with charcot foot. This is done by measuring local blood samples in the feet, and systemically in a vene and an artery. Measurements are done before and after cooling the feet in icewater to lower the bloodflow. Patients will be compared with healthy diabetic controls.

Conditions
-----------------
Arthropathy, Neurogenic, Diabetes Complications, Diabetes Mellitus

Intervention / Treatment
-----------------
* Procedure: Blood sample measurements


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes mellitus type 1 or 2 Charcot foot diagnosed with x-ray, scintigraphy or clinical review by a specialist Exclusion Criteria: Osteoporosis Anti-osteoporotic treatment Lower extremity amputation Lower extremity infection
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetics with Charcot foot<br> | Procedure: Blood sample measurements<br>* Blood samples are drawn in the feet and arms (a/v) before and after cooling the feet with ice water<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RANKL |  | 10 min between measurements | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| osteocalcin |  | 10 min between measurements | 
| CTX-I |  | 10 min between measurements | 
| sRAGE |  | 10 min between measurements | 
| P1NP |  | 10 min between measurements |
TD-1792 in Gram-positive Complicated Skin and Skin Structure Infection

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether TD-1792 is safe and effective when used to treat complicated skin and skin structure infections caused by Gram-positive bacteria.

Detailed Description
-----------------
TD-1792 is compared to vancomycin for the treatment of cSSSI.

Official Title
-----------------
A Phase 2, Randomized, Double Blind, Study of Intravenous TD 1792 Versus Vancomycin for Treatment of Complicated Gram Positive Skin and Skin Structure Infections

Conditions
-----------------
Staphylococcal Skin Infection

Intervention / Treatment
-----------------
* Drug: TD-1792
* Drug: Vancomycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: major abscess requiring surgical incision and drainage,infected burn, deep/extensive cellulitis, infected ulcer, wound infections requires at least 7 days of intravenous antibiotic treatment Exclusion Criteria: more than 24 hours of antibiotic therapy moderate or severe liver disease severely neutropenic baseline QTc > 500 msec, congenital long QT syndrome, uncompensated heart failure, uncorrected abnormal K+ or Mg++ blood levels or severe left ventricular hypertrophy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TD-1792<br> | Drug: TD-1792<br>* TD-1792 2 mg/kg/day IV<br>|
| Active Comparator: Vancomycin<br> | Drug: Vancomycin<br>* Vancomycin 1 Gm IV q 12 hrs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response |  | 7 to 14 days after last antibiotic dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cSSSI, Staph, MRSA