linjc16/ctgov huggingface dataset:
Skin Cancer Oncology Radiation Evidence Registry

Study Overview
=================
Brief Summary
-----------------
To collect and analyze long term safety and efficacy outcomes of patients undergoing radiotherapy for non-melanoma skin cancer. A target of 400 VMAT-treated sites is set which is estimated to be identified in approximately 350 participants. Participants referred for radiotherapy for the management of non-melanoma skin cancer.

Detailed Description
-----------------
The Registry will collect information on key clinical indications and patient reported outcomes to assess the safety and efficacy of VMAT radiotherapy. Data that will be collected includes baseline data of demographic, relevant medical history, photographs, treatment schedule, and treatment outcomes. Data may be collected retrospectively in regard to previous relevant medical history, prior treatments and outcomes as well as prospectively, including treatment schedule and treatment outcomes of radiotherapy treatment. The Registry aims to assess the safety and outcomes of treatment for up to 5 years. This Registry will be the first of its kind in the US and will provide a basis for a number of potential research publications. The Registry will also give insights into treatment delivery and potentially facilitate future improvements in patient care.

Official Title
-----------------
Skin Cancer Oncology Radiation Evidence Registry

Conditions
-----------------
Non-melanoma Skin Cancer

Intervention / Treatment
-----------------
* Behavioral: There is no medical intervention for the purposes of this Registry.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years of age Diagnosed with a treatable non-melanoma skin cancer by referring medical practitioner Eligible to be treated using widefield (>50cm2) VMAT radiotherapy as determined by RO Patient has provided written informed consent. Exclusion Criteria: ♦ Patients who do not consent to their involvement in the Registry.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: There is no medical intervention for the purposes of this Registry.|There is no medical intervention for the purposes of this Registry.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants will have their responses to radiotherapy after treatment of non-melanoma skin cancer measured and reported as number of participants with treatment-related adverse events as assessed by CTCAE v4.0. | To assess participant safety following treatment of non-melanoma skin cancers with radiotherapy. | 5 years |
Impact of Sleep Quality on Respiratory Function and Weaning of Mechanical Ventilation

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the impact of sleep quality on the length of mechanical ventilation weaning, in intensive care unit patients

Conditions
-----------------
Sleep Quality, Weaning of Mechanical Ventilation

Intervention / Treatment
-----------------
* Other: Polysomnography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mechanical ventilation for at least 24 hours before the first weaning test difficult weaning of mechanical ventilation defined as failure to the first weaning test patients aged at least of 18 years Exclusion Criteria: peripheral or central nervous system pathology known psychiatric pathology or agitation clinical worsening before polysomnography (shock with vasopressor drugs, coma with Glasgow scale < 8, PaO2/FiO2 ratio < 150 with respiratory distress signs) pregnant or breastfeeding women patient under legal guardianship or protection patient with no health insurance coverage age < 18 years

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 |
| --- |
|Other: Polysomnography|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the length of weaning patients who have a poor quality of sleep to those who have a good quality sleep. |  | 24 hours |
Safety Study of Melatonin in Stroke Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the effect of Melatonin (in a dosage of 14mg daily) for a better clinical outcome in the period three days post stroke.

Detailed Description
-----------------
Stroke is the third most common cause of stroke. The cascade of event is separated into hyperacute,,acute,sub-acute and chronic. In the acute, sub acute state there are mechanisms of inflammation apoptotic death and effect of free radicals. Melatonin was proved to effect these mechanisms and to have a favourable effect in different diseases. The aim of the study is to prove That the use of Melatonin in a higher dosage may have a anti-destructive effect in stoke.

Official Title
-----------------
A Double Blind, Placebo Controlled Study to Evaluate the Efficacy of Melatonin in Acute Ischemic Stroke.

Conditions
-----------------
Acute Ischemic Stroke

Intervention / Treatment
-----------------
* Drug: Melatonin
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: within 72hours of ischemic stroke age 18-80 both gender ability to sign consent form Exclusion Criteria: intra-cerebral bleeding tumour of brain multiple sclerosis s/p craniotomy known allergy to melatonin

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Active Comparator: Melatonin<br>Melatonin 14mg/daily given over 14 days | Drug: Melatonin<br> <br> |
| Placebo Comparator: sugar pill<br>sugar pill given over 14 days | Drug: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of at least one point on the MRS score |  | 3 months |
Single Ascending Dose Study (SAD) iv Formulation

Study Overview
=================
Brief Summary
-----------------
The purpose is to study the safety of AZD1305, how AZD1305 is tolerated and how the medication is metabolised by the body (how it is taken up into the body, distributed around the body and disappears from the body

Official Title
-----------------
A Single-centre, Single-blind, Randomised, Placebo-controlled, Single-dose Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics After Ascending Intravenous Doses of AZD1305 in Helahty Male Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: AZD1305
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers BIM 19-30 kg/m2 Exclusion Criteria: Potassium outside normal reference values ECG findings outside normal range

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>AZD1305 solution for iv infusion | Drug: AZD1305<br>* Solution for iv infusion , single dose<br>|
| Placebo Comparator: B<br>NaCl solution for iv infusion | Drug: Placebo<br>* NaCl solution for iv infusion, single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events, ECG variables, vital signs, physical examination, laboratory variables, body temperature and weight |  | During the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic variables |  | During all dosing visits | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AZD1305, SAD, safety, pharmcokinetics, Safety and tolerability
Effect of Dutasteride on HIF-1alpha and VEGF in the Prostate

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether dutasteride may influence the expression of angiogenesis factors such as hypoxia inducible factor (HIF)-1alpha and vascular endothelial growth factor (VEGF) in patients with lower urinary tract symptoms/benign prostatic hyperplasia (LUTS/BPH).

Detailed Description
-----------------
A total of 41 patients awaiting transurethral resection of the prostate (TURP) will be divided into two groups (1:1); twenty patients will receive no medication and 21 will receive 0.5 mg dutasteride daily for 2 to 4 weeks until TURP. In both groups, the extent, intensity and intracellular location of hypoxia inducible factor (HIF)-1alpha and vascular endothelial growth factor (VEGF)will be evaluated. Microvessel density will be also compared in the two groups.

Official Title
-----------------
Apoptosis and Expression of Neovascularization-related Factors in Human Prostate Tissue After Administration of Dutasteride

Conditions
-----------------
Benign Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Drug: dutasteride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: informed consent 50 years old or older International Prostate Symptom Score (IPSS) >8 Maximum flow rate (Qmax) <15 ml/s transurethral resection of the prostate (TURP) Exclusion Criteria: urethral catheter urinary tract infection (UTI) liver disease renal disease unexplained hematuria prostate specific antigen (PSA) > 4ng/ml (included if prostate biopsy was negative) interstitial cystitis bladder cancer or prostate cancer pelvic surgery or irradiation

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

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: dutasteride<br>oral, 5mg, once per day, 2 weeks | Drug: dutasteride<br>* 5mg, oral, daily, 2-4 weeks<br>|
| Placebo Comparator: placebo<br>oral, 5mg, once per day, 2 weeks | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIF-1a and VEGF expression | effects of dutasteride on the expression of angiogenesis markers in rat and human prostates | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostate, dutasteride, vascular endothelial growth factor, hypoxia inducible factor
Target Therapies Resistance Molecular Profiling in Patients With Neoplastic Disease

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to define the molecular profile of selected solid tumors. From each participants will be collected biological materials for molecular analysis, including saliva, blood and vital tumor tissue derived form surgical or biopsy procedures. Whereas possible, vital tumor specimens will be inoculated and propagated in immunocompromised NOD/SCID mice to study the genetic correlations between genetic status and response to target drugs.

Official Title
-----------------
Non-interventional Study for the Determination of Molecular Resistance Profiling to Targeted Therapies in Patients With Neoplastic Disease

Conditions
-----------------
Solid Tumors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with at least one of the following selected solid tumors: Colorectal Cancer (primary or with synchronous/metachronous liver metastases) Prostate Cancer Head & Neck Tumors Gastric Cancer Glioblastoma Breast Cancer Hepatocarcinoma Biliary Tract Carcinoma Lung Cancer (primary) Rare Tumors (incidence ≤ 5x10-6) Metastatic Sarcoma Metastatic Melanoma Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| number of patient correctly sampled | number of patients with biological samples idoneous for molecular profiling testing (nucleic acid extraction, protein) over all recruited patients. | through study completion, an average of five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with detected genetic alterations that respond to treatments assigned by physician. |  | through study completion, an average of five years |
Spanish Registry of Mohs Surgery

Study Overview
=================
Brief Summary
-----------------
REGESMOHS (Registro Español de cirugía de Mohs) aims at describing effectiveness of Mohs surgery, and patient, tumor and technique factors related to adverse events and tumor recurrence. REGESMOHS is a prospective cohort, including all patients considered for Mohs surgery in participating centers. All consecutive patients are included. The only exclusion criteria are being under 18-years-old or legally incompetent. Pre-planned follow-up is as required by common clinical practice, but at least once a year for the study period.

Official Title
-----------------
Spanish Registry of Mohs Surgery [Registro Español de Cirugía de Mohs]

Conditions
-----------------
Skin Neoplasms, Carcinoma, Basal Cell, Carcinoma, Squamous Cell, Dermatofibrosarcoma, Melanoma, Histiocytoma, Malignant Fibrous, Neoplasms, Adnexal and Skin Appendage

Intervention / Treatment
-----------------
* Procedure: Mohs surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All consecutive patients considered for Mohs surgery Exclusion Criteria: Under 18 years-old Legally incompetent

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 |
| --- | --- |
| Mohs surgery<br>Patients treated using Mohs surgery. Other exposures considered include patient characteristics, preoperative care and technical variants. | Procedure: Mohs surgery<br>* A surgical technique used primarily in the treatment of skin neoplasms, especially basal cell or squamous cell carcinoma of the skin. This procedure is a microscopically controlled excision of cutaneous tumors either after fixation in vivo or after freezing the tissue. Serial examinations of fresh tissue specimens are most frequently done.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor recurrence |  | 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short term outcomes | Bleeding, infection, abnormal scar, necrosis | 1 month | 
| Use of resources | Need for admission, type of anesthesia, number of surgical steps, participating doctors,time in surgery room. | During surgery | 
| Impairments of body function and structure | presence of: abnormal scar, ectropion, nostril alteration, oral sphincter incompetence,other | 6 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mohs Surgery
The Impact of Platelet Functions on Spontaneous Ductal Closure in Preterm Infants

Study Overview
=================
Brief Summary
-----------------
Although thrombocytopenia has been reported as a risk factor for patent ductus arterioses, there is lack of data on the function of platelets in ductal closure. Information on functions of platelets in ductal closure may change the known model for ductus arterioses and may affect the treatment modalities.

Detailed Description
-----------------
Patent ductus arterioses is a common problem which involves both pulmonary and cardiac outcomes in preterm infants. Although thrombocytopenia has been reported as a risk factor for patent ductus arterioses, there is lack of data on the function of platelets in ductal closure. The investigators aim to investigate the relation between thrombocytopenia and platelet functions in pathogenesis of spontaneous ductal closure. The investigators hypothesize that Information on functions of platelets in ductal closure may change the known model for ductus arterioses and may affect the treatment modalities.

Official Title
-----------------
The Impact of Platelet Count, Platelet Mass Index and Platelet Function Evaluated by Platelet Function Analyzer (PFA-100) on Spontaneous Ductal Closure in Preterm Infants

Conditions
-----------------
Patent Ductus Arterioses

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: gestational age lower than 30 weeks and birth weight lower than 1500 g obtained informed consent Exclusion Criteria: any received medical treatment in first 2 days of life death in first 2 days patients who received any thrombocyte or fresh frozen plasma suspensions any known genetic thrombocyte disorder in the family

Ages Eligible for Study
-----------------
Minimum Age: 2 Days
Maximum Age: 7 Days

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| spontaneous ductal closure | ductal closure confirmed by echocardiography on postnatal 2-3 days | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| need for treatment | any need for medical treatment (ibuprofen or paracetamol) or surgical treatment | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patent ductus arterioses, ductal closure, thrombocyte
A Comparison of Clinical Simulation and Classical Learning for Airway Management in Medical Students

Study Overview
=================
Brief Summary
-----------------
Multiple studies have shown clinical simulation benefits over classical learning method. Research on simulation of airway management has focused on endotracheal intubation training, while research on ventilation via facemask is scant. The investigators compared both learning methods regarding the acquirement of basic skills for airway management by medical students. Students in the clinical simulation group received a 3-hour training on airway management on the first day of their 28-day anesthesia rotation, while classical learning did not. On the last day of rotation, participants were evaluated based on a validated instrument of scores. Primary outcome was airway management scores. Secondary outcomes were rate of success of intubation and incidence of complications.

Official Title
-----------------
Title: A Comparison of Clinical Simulation and Classical Learning for Airway Management in Medical Students: a Randomized Controlled Trial

Conditions
-----------------
Educational Activities

Intervention / Treatment
-----------------
* Other: Clinical Simulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Last year medical students at Universidad de los Andes Over 18 year old Exclusion Criteria: Previous elective anesthesia rotation Motor deficit affecting the upper limbs

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clinical Simulation<br> | Other: Clinical Simulation<br> <br> |
| No Intervention: Classical Learning<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Airway management score |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful intubation rate |  | 28 days | 
| Incidence of complications |  | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Educational Technology, Airway Management, Medical students, Intratracheal intubation