linjc16/ctgov huggingface dataset:
Study of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Lung Cancer

Study Overview
=================
Brief Summary
-----------------
this study is being done to find out if the combination of carboplatin and gemcitabine will be more effective in the the treatment of advanced lung cancer if bevacizumab, an agent that blocks tumor blood vessel formation, is added the study will measure the time to progression of patients treated with the combination; we hope to show that the addition of bevacizumab improves the time to progression (increases the amount of time before the disease begins to worsen) all patients receive all three drugs; there is no placebo

Detailed Description
-----------------
Patients with advanced (stage IV, and Stage IIIB with effusion) non-small cell lung cancer with non-squamous histology, good performance status, and adequate organ function are eligible. Patients with brain metastases, squamous histology, or hemoptysis are excluded. All patients must give informed consent. Schema gemcitabine 1250 mg/M2 IV day 1,8 carboplatin AUC 5 IV day 1 bevacizumab 15 mg/kg IV day 1 repeated every 21 days for 6 cycles

Official Title
-----------------
Phase II Trial of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Non-Small Cell Lung Cancer

Conditions
-----------------
Non-Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: bevacizumab
* Drug: carboplatin
* Drug: gemcitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically proven non-small cell lung cancer, newly diagnosed or recurrent after previous surgery and/or radiation therapy Stage IV disease or stage IIIB with a malignant pleural effusion measurable or evaluable disease Performance status 0 or 1 (ECOG) adequate renal, hepatic, and bone marrow function adequate recovery from previous surgery or radiotherapy informed consent Exclusion Criteria: brain metastases squamous (epidermoid) histology hemoptysis central airway disease Pancoast tumors previous chemotherapy or biologic therapy for lung cancer prior malignancy within the previous 5 years except non-melanoma skin cancer or cervical CIS pregnant or nursing 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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: bevacizumab|nan|
|Drug: carboplatin|nan|
|Drug: gemcitabine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to progression |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate |  |  | 
| median survival |  |  | 
| one year survival |  |  | 
| two year survival |  |  | 
| toxicity |  |  |
Improving Safety of Antivenom in People Bitten by Snakes

Study Overview
=================
Brief Summary
-----------------
A study to increase the safety of polyvalent antivenom involving 1000 patients in three centres: low dose adrenaline, promethazine, & hydrocortisone (alone and in combination) to prevent acute adverse reactions to antivenom in people bitten by snakes: randomised, double blind, placebo-controlled trial.

Official Title
-----------------
Low Dose Adrenaline, Promethazine, & Hydrocortisone (Alone and in Combination) to Prevent Acute Adverse Reactions to Antivenom in People Bitten by Snakes: Randomised, Double Blind, Placebo-Controlled Trial

Conditions
-----------------
Snake Bites

Intervention / Treatment
-----------------
* Drug: adrenaline, promethazine, hydrocortisone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Above 12 years of age Patients admitted to hospital after snake bite in whom antivenom is indicated Patients who give informed consent Exclusion Criteria: Patients who are pregnant or nursing Patients who are currently taking beta- or alpha-adrenoceptor antagonists, or tricyclic antidepressants Patients in whom adrenaline may be contraindicated (this may include patients with the following: history of ischaemic heart disease, stroke, uncontrolled hypertension, and tachyarrhythmias)

Ages Eligible for Study
-----------------
Minimum Age: 12 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: Factorial Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: adrenaline, promethazine, hydrocortisone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of severe reactions to antivenom in the first 48 hours |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of moderate & severe reactions to antivenom in the first 48 hours |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Controlled trial, Snake bite, Safety, Antivenom
Burden of Disease in Hypophosphatasia (HPP)

Study Overview
=================
Brief Summary
-----------------
Hypophosphatasia (HPP) is a rare, inherited metabolic disease caused by inactivating mutations in the Alkaline Phosphatase (ALPL) gene, coding for the Tissue-nonspecific alkaline phosphatase (TNAP). Penetrance and disease severity is very heterogenous, ranging from stillbirth to adult-onset manifestations. Especially the latter are again characterized by an extremely broad spectrum of symptoms. This scope of variability makes it difficult to attribute individual patients' symptoms to the disease and distinguish them from HPP independent health issues. Especially in adult HPP patients, musculoskeletal problems, including (fragility-) fractures / bone bruise, joint pain, reduced mobility, muscular weakness and pain and reduced muscular endurance appear to reflect the prevailing burden of disease, especially with respect these patients dis-abilities of daily life. To expand current knowledge of the natural history of the disease as well as on disease specific musculoskeletal deficits in HPP, all adult patients with established Diagnosis of HPP known at the Orthopedic Institute, University of Würzburg, will be offered to participate in a single, multimodal assessment of their disease history, current symptoms and disabilities, lab evaluations and clinical and technical analysis of their musculoskeletal status and capabilities. Patients will be invited to a day long visit to the clinic in order to perform the following assessments: A) Epidemiologic / anamnestic information B) Physical examination C) Structured questionnaires D) Laboratory examinations E) Clinical functional testing F) Technical Examinations

Official Title
-----------------
Non-interventional, Prospective, Single-center Investigation With Exploratory Data Analysis to Delineate the Variability and Frequency of Symptoms and Disease Manifestations in Adult HPP Patients

Conditions
-----------------
Hypophosphatasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult males and females (age ≥ 18 years) Established diagnosis of Hypophosphatasia Reduced Serum/Plasma ALP (Alkaline phosphatase)-Activity below age and sex specific reference range of the respective test kit applied (measured at least twice with a minimum 4 week interval) At least one of the items below: Genetically secured ALPL-Mutation Elevated PLP (Pyridoxal 5-Phosphate) (urine or serum), above ULN (Upper level of normal) Symptoms of the disease Signed informed consent Exclusion Criteria: Current / previous treatment with Asfotase alfa Current participation in another clinical study

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 |
| --- | --- | --- |
| Frequencies of main disease symptoms and main disease manifestations |  | 2 years |
CryoSpray Ablation (TM) GI Patient Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to create a patient registry to collect and analyze post-510K approval information on subjects treated endoscopically with the CryoSpray Ablation™ System.

Detailed Description
-----------------
The proposed registry is a prospective, multi-center study of patients that are being currently undergoing CryoSpray Ablation™. It will also be used to catalogue retrospective data from records of patients already treated with the device. A maximum of 40 investigational sites will participate in this study.

Official Title
-----------------
CryoSpray Ablation (TM) GI Patient Registry

Conditions
-----------------
Barrett's Esophagus, Esophageal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The study population consists of patients who are being treated, or were treated, with the CryoSpray Ablation™ System for malignant or pre-malignant conditions of the esophagus, including: Barrett's esophagus with or without dysplasia Squamous dysplasia of the esophagus Esophageal cancer, any stage Exclusion Criteria: Subjects with esophageal lesions whose pathology was not one of the above. Subjects with one of the above conditions who were not treated with the CryoSpray Ablation™ System.

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 |
| --- | --- | --- |
| Primary objectives of the study are to enable analysis of patient outcomes 2 years after final treatment and report on the effectiveness of the device in eradicating, decreasing or downgrading of the lesions. |  | 2 years post treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Barrett's Esophagus, High Grade Dysplasia, Low Grade Dysplasia, Squamous Dysplasia, Esophageal Cancer, CryoSpray Ablation, Cryotherapy, Cryospray
Metabolome Analysis in Patients With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate discriminant metabolites in urine from patients with rheumatoid arthritis (RA) from healthy individuals. Then we determine if the patient's metabolic fingerprint could predict the development or flare-up of RA.

Detailed Description
-----------------
Compare metabolites between RA patients and healthy individuals. Collection urine sample Assessing urine metabolites by 1H NMR spectroscopy Analyzing the relationships between metabolites and clinical variables

Official Title
-----------------
Metabolome Analysis in Patients With Rheumatoid Arthritis

Conditions
-----------------
RheumatoId Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with rheumatoid arthritis meet 2010 American College of Rheumatology/European League against Rheumatism classification criteria. Exclusion Criteria: Comorbid with other autoimmune diseases Confirmed with amyloidosis Chronic kidney disease (estimated GFR < 60 ml/min/1.73m2) Chronic liver disease Thyroid disease Pregnancy Solid tumor/hematologic malignancy within 5 years

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic fingerprint of rheumatoid arthritis | Metabolomic analyses of urine from patients with rheumatoid arthritis, healthy controls and other autoimmune disease | 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlations between specific metabolites and disease activity/severity of RA | Identified metabolites and their clinical significances | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rheumatoid arthritis, Metabolomics, urine
Prevalence Study of Iron Deficiency in Patients With Cancer

Study Overview
=================
Brief Summary
-----------------
Despite its high prevalence, a recent study conducted by Prof. Cacoub (unpublished) on the french national health insurance database showed that iron deficiency was an underdiagnosed and under-treated co-morbidity. In inflammatory situations, especially during cancer, the measurement of the transferrin saturation factor is only performed in about 10% of cases whereas this measure is recommended in inflammatory situations including cancer (French Health High Authority 2011)

Official Title
-----------------
Prevalence Study of Iron Deficiency in Patients With Cancer

Conditions
-----------------
Iron-deficiency

Intervention / Treatment
-----------------
* Diagnostic Test: Iron deficiency testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient, male or female, over the age of 18 Patient in an oncology department (any type of tumor, any type of treatment, initiated or not) Patient affiliated or beneficiary of a social security system Patient with written consent Exclusion Criteria: Protected patient: major under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision Patient hospitalized without consent

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ONCOLOGY<br>Patient with a cancer | Diagnostic Test: Iron deficiency testing<br>* Blood sample for complete iron status<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood iron status | ferritin, haemoglobin, transferrin saturation factor | One day |
Prediction of Falls in Older Inpatients Hospitalized at Angers University Hospital

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to elaborate a new simple clinical tool for the risk of falls among older inpatients.

Detailed Description
-----------------
Falling is a common event within hospitals, with a rate calculated between 2.9-13 per 1,000 bed-days . Falls lead to prolonged length of hospital stays (LHS). The first step of an efficient and cost-effectiveness strategy of fall prevention is the screening of individuals at higher risk of falls. Recently, a brief geriatric assessment (BGA) composed of a few number of items has demonstrated to successfully predict the risk of prolonged LHS (5). We hypothesized that the use of the BGA items would make it possible to predict the occurrence of falls among older inpatients.

Official Title
-----------------
Nurse Screening Tool for Fall Risk : Prediction of Falls in Older Inpatients Hospitalized at Angers University Hospital

Conditions
-----------------
to Elaborate a New Simple Clinical Tool for the Risk of Falls Among Older Inpatients.

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 65 years participants who did not issue opposition to participation in the study Patients hospitalized at the University Hospital of Angers in acute care units participating in study Being affiliated to a social security regime Exclusion Criteria: Opposition to the use of information collected for research purposes. Age < 65 years

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- | --- |
| Clinical characteristics (i.e., Brief geriatric assessment items) |  | recorded at baseline when older adult were admited to acute care units. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of falls |  | assessed between 2 and 21 hospitalization days | 
| Number of falls |  | assessed between 2 and 21 hospitalization days | 
| Severity of falls |  | assessed between 2 and 21 hospitalization days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
assessment; falls; older adults; prediction scale; standardized declaration
Preoperative Noninvasive Hemoglobin Monitoring in Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
The preoperative evaluation including sampling blood in pediatric patients is hard to perform. However, the knowledge of the baseline cell blood count is important to prepare unexpected surgical bleeding etc.. The invasive procedure for blood sampling in small children is often failed and sometimes induces iatrogenic blood loss and parent's complaints. The Pulse Co-oximetry (Masimo) is recently developed device which can provide noninvasive hemoglobin value. However, the accuracy is controversial. There are studies in pediatric patients during surgery and in ICU. However, the comparison for preoperative evaluation is not analysed. Therefore, the investigators want to evaluate the accuracy for preoperative preparation in pediatric patients.

Detailed Description
-----------------
There are not enough data comparing the noninvasive hemoglobin and venous hemoglobin in pediatric patients during preoperative period. The investigators will collect the venous sample and the noninvasive hemoglobin data from masimo within 1 hour. Without any additional medication, the patients will visit preanesthetic room and attach the probe of masimo on index finger. The R 20L or R25L will be used based on their weight. The parameter will be stabilized within 2 minutes and the SpHb and perfusion index will be recorded.

Official Title
-----------------
The Accuracy of the Noninvasive Hemoglobin Monitoring for Preoperative Evaluation for Pediatric Patients

Conditions
-----------------
Surgery

Intervention / Treatment
-----------------
* Other: No treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA class 1,2 Exclusion Criteria: Poor peripheral circulation Infection or trauma on the sensor contact region

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
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 |
| --- | --- |
| single arm study<br>No treatment or intervention will given to the patients | Other: No treatment<br>* Attach adhesive probe on thumb or index finger<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemoglobin | no F/U is needed | once, preoperative visit anesthetic office | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemoglobins, Monitoring, Outpatient, Preoperative Period, Pediatrics
Evaluation of Serum Interleukin-15 and Interleukin-22 Levels in Patients With Non-segmental Vitiligo

Study Overview
=================
Brief Summary
-----------------
Evaluation of Serum Interleukin-15 and Interleukin-22 Levels in Patients with Non-segmental Vitiligo before and after phototherapy

Detailed Description
-----------------
This prospective study will include 30 patients with NSV, attending the Outpatient Clinics of Dermatology at Sohag University Hospitals, as well as 30 normal volunteers as control. This study will be submitted for approval by Research and Ethical committees at Sohag Faculty of Medicine. An informed written consent will be obtained from each subject prior to participation in the study after full explanation of the procedure.

Official Title
-----------------
Evaluation of Serum Interleukin-15 and Interleukin-22 Levels in Patients With Non-segmental Vitiligo

Conditions
-----------------
Vitiligo

Intervention / Treatment
-----------------
* Diagnostic Test: Interleukin-15 and Interleukin-22


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Patients suffering from non segmental vitiligo. Patients not on medical treatment or phototherapy for vitiligo in the last 3 months. Exclusion Criteria: • Patients with systemic or cutaneous inflammatory disorders. Patients on treatment for vitiligo in last 3 months. Pregnant and lactating patients. Patients with history of diabetes. Patients with history of autoimmune diseases.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: non segmental vitiligo<br>serum analysis | Diagnostic Test: Interleukin-15 and Interleukin-22<br>* Serum Interleukin-15 and Interleukin-22 in non segmental vitiligo<br>|
| Active Comparator: normal volunteer<br>serum analysis | Diagnostic Test: Interleukin-15 and Interleukin-22<br>* Serum Interleukin-15 and Interleukin-22 in non segmental vitiligo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Serum Interleukin-15 and Interleukin-22 Levels | 3 ml venous blood will be obtained from participante using commerciall available double antibody sandwich enzyme-linked immunosorbent assay (ELISA) kits to evaluate Serum IL15 level . Serum IL22 level. 3 ml venous blood will be obtained from participante using commerciall available double antibody sandwich enzyme-linked immunosorbent assay (ELISA) kits to evaluate 1. Serum IL15 level . 2. Serum IL22 level. | 3 months |