linjc16/ctgov huggingface dataset:
Prediction of Esophageal and Lung Toxicities After Radiation (Chemo) Therapy

Study Overview
=================
Brief Summary
-----------------
(Chemo)-radiotherapy is the gold standard therapeutic treatment for patients with locally advanced lung cancer non accessible or ineligible for surgery. While some progress occurred regarding progression free survival and overall survival thanks to recent advances (i.e., durvalumab), prediction of pulmonary and esophageal toxicity, remains insufficiently accurate. Current dose-volume histograms (DVH) do not account for spatial dose distribution and strict application of current dose constraints does not prevent toxicity events in some of the treated patients. The goal of this work was to investigate the added predictive value of the radiomics approach applied to dose maps regarding acute and late toxicity in both lungs and the esophagus.

Official Title
-----------------
Prediction of Esophageal and Lung Toxicities After Radiation (Chemo) Therapy for Lung Cancer Management

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients treated by (chemo)-radiotherapy for a primary lung cancer by radiotherapy Exclusion Criteria: Incomplete treatment

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction of Acute Pulmonary Toxicity | The model's performance will be evaluated based on the observed rate of Acute Pulmonary Toxicity using classification metrics (area Under the curve, balanced accuracy). | Up to 6 months | 
| Prediction of Late Pulmonary Toxicity | The model's performance will be evaluated based on the observed rate of Late Pulmonary Toxicity using classification metrics (area Under the curve, balanced accuracy). | Between 6 months and 2 years after radiotherapy | 
| Prediction of Acute Oesophageal Toxicity | The model's performance will be evaluated based on the observed rate of Acute Oesophageal Toxicity using classification metrics (area Under the curve, balanced accuracy). | Up to 6 months | 
| Prediction of Late Oesophageal Toxicity | The model's performance will be evaluated based on the observed rate of Late Oesophageal Toxicity using classification metrics (area Under the curve, balanced accuracy). | Between 6 months and 2 years after radiotherapy |
Iron Deficiency Anaemia in Pregnant Patients Presenting for Antenatal Care

Study Overview
=================
Brief Summary
-----------------
This is a cross-sectional, prospective study of iron deficiency anaemia among pregnant patients presenting for antenatal care at a secondary level institution in the Western Cape, Mowbray Maternity Hospital, over a one-week period.

Official Title
-----------------
A Cross-sectional Prospective Study of the Prevalence of Iron Deficiency Anaemia in Pregnant Patients Presenting for Antenatal Care at a Secondary Level Institution, Mowbray Maternity Hospital

Conditions
-----------------
Iron Deficiency Anemia of Pregnancy

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All women presenting to the antenatal care services at Mowbray Maternity Hospital over the period of study recruitment. ≥ 18 years of age. Screen as anaemic (World Health Organisation <11g/dl) on bedside finger-prick haemoglobin. Who consent to participate. Exclusion Criteria: Patients who refuse to participate, and those under the age of 18 years will be excluded from the study.

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

| Intervention/Treatment |
| --- |
|Other: No intervention|No intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of anaemia among all women presenting for antenatal care at a secondary level institution in the Western Cape, Mowbray Maternity Hospital, during a one-week period. | Proportion | One week |
Facial Type Determination Through Cephalometry, Anthropometry and Facial Analysis

Study Overview
=================
Brief Summary
-----------------
Introduction: Human face with its bony and muscular structures has singular and peculiar characteristics. It may be classified in three types, associated with the variation of shape and craniofacial configuration, both in vertical and horizontal planes, directly affecting dental occlusion, face harmony, orofacial musculature and oral functions. Aim: to correlate cephalometric with anthropometric and facial analysis findings on determining the facial type. Method: 105 leukoderm adults were involved, 34 male and 71 female aging between 20 and 40 years old. Data were collected in December 2006 in an orthodontic clinic located at Belo Horizonte- MG, Brazil. Cephalometric findings to determinate facial types were compared to seven anthropometric facial measurements, three anthropometric facial proportions and three anthropometric facial indices, in addition to facial type identification through clinical facial analysis of photographs.

Official Title
-----------------
Facial Type Determination Through Ricketts Cephalometric Analysis, Anthropometric Measurements, Indices and Proportions and Facial Analysis Performed by Means of Photographs

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: to have Ricketts cephalometric analysis Exclusion Criteria: to have been submitted on orthognathic surgery black or asian people

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Face, Cephalometry, Anthropometry, Photography, Diagnosis, Adult, Morphology, Comparative Study
A Study Of PF-03882845 Absorption In Healthy Volunteers Given Orally As Tablet Versus Suspension Formulations And Effect Of Food On Its Absorption

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to estimate the relative bioavailability and food effect of a PF-03882845 tablet as compared to a suspension formulation used in previous clinical studies.

Official Title
-----------------
A Randomized, Open-Label, Single Dose, Crossover Study To Estimate The Relative Oral Bioavailability And Food Effect Of PF-03882845 In Healthy Adult Volunteers

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: PF-03882845
* Drug: PF-03882845
* Drug: PF-03882845


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and/or female subjects between the ages of 18 and 55 years,Females must be of non-childbearing potential. Body mass index of 17.5 to 30.5 kg/m2. Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures. Exclusion Criteria: Serum potassium >5 mEq/L at screening. Impaired kidney function (estimated GFR <60 mL/min/1.73 m2). History of sensitivity to eplerenone, spironolactone, or related compounds.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Suspension/fasted<br> | Drug: PF-03882845<br>* 25 mg of PF-03882845 suspension (75% SDD) will be given as a single oral dose under fasted condition<br>|
| Experimental: Tablet/fasted<br> | Drug: PF-03882845<br>* 25 mg PF-03882845 Tablet (75% SDD) will be given as a single oral dose under fasted condition<br>|
| Experimental: Tablet/fed<br> | Drug: PF-03882845<br>* 25 mg PF-03882845 Tablet (75% SDD) will be given as a single oral dose under fed condition<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PF-03882845 PK: Cmax, AUCinf, AUClast, Tmax, t1/2, as data permit. | Post dose is measured at 24, 48 and 96 hours after dose. | predose and post each dose (24, 48 and 96 hour timepoints) | 
| Safety: Safety labs, vital signs, ECGs, physical examinations and adverse event monitoring. |  | 45 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Relative bioavailability, food effect, tablet, suspension, single dose, crossover, healthy subjects
Study in Patients With COPD

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine which dose of the investigational drug is the most safe and effective for the treatment of COPD compared to the control drug

Conditions
-----------------
COPD, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Drug: Formoterol Fumarate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of COPD History of cigarette smoking Exclusion Criteria: Clinical diagnosis of asthma Significant pulmonary disease other than COPD Other significant major organ disease(s)

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 70 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Formoterol Fumarate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of lung function |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lung function, as well as vital signs |  |  | 
| Physical Exam results, adverse event reporting, etc |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, Chronic Obstructive Pulmonary Disease, Formoterol Fumarate, Formoterol
Vitamin D Improves Clinical Manifestations in Asthmatic Children

Study Overview
=================
Brief Summary
-----------------
Objectives: Evaluation of the effect of vitamin D supplemental therapy (VDST) on clinical manifestation of bronchial asthma (BA) as judged by The International Study of Asthma and Allergies in Childhood (ISAAC) questionnaire and estimated serum levels of immunoglobulin E (IgE). Patients & Methods: scores of ISAAC questionnaire and blood samples were obtained for estimation of serum IgE and 25-hydroxy VD (25-HVD) at booking time (T1) of 102 BA patients. VDST was provided as 2000 IU daily for 3 and 6 months for patients had moderate and mild HVD, respectively. At the end of 12-m after start of VDST (T2), ISAAC questionnaire and serum levels of 25-HVD and IgE were re-evaluated and the percentage of change was calculated.

Official Title
-----------------
Vitamin D Supplemental Therapy for Asthmatic Children May Improve Clinical Manifestations and Reduce IgE Serum Levels

Conditions
-----------------
Asthma in Children

Intervention / Treatment
-----------------
* Drug: Vit D


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in the age group of 6-14 years, free of exclusion criteria and complaining of chest wheezes were included in the study. Exclusion Criteria: Presence of acute asthmatic attack, current or recurrent chest infection, allergic dermatological disorders, chronic rhino-sinusitis, deviated nasal septum, other nasal or palatal congenital anomalies, history of chronic exposure to allergens, or living in areas characterized by air pollution, being passive smokers since birth, presence of autoimmune disorders, serum 25-HVD >50 nmol/L and presence of clinically evident HVD.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 14 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin Deficiency<br> | Drug: Vit D<br>* Vit D was provided as 2000 IU daily for 3 and 6 months for patients who had mild and moderate HVD, respectively.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Improvement | The effect of vitamin D supplemental therapy on pediatric asthma severity as judged by the score of ISSAC questionnaire. | 3 to 6 months |
Generation of Heparin-induced Thrombocytopenia (HIT)-Antibodies Without Prior Heparin Exposure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the HIT-antibody generation without prior heparin-exposure in patients undergoing orthopedic surgery.

Official Title
-----------------
Generation of HIT-antibodies Without Prior Heparin Exposure Following Orthopedic Surgery (Subgroup Study) (Change of Coagulation Parameters Under Exposition With New Anticoagulants [Title of the Main Study])

Conditions
-----------------
Heparin-Induced Thrombocytopenia, Thrombosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major orthopedic surgery Exclusion Criteria: Heparin exposure Infection

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 |
| --- | --- | --- |
| incidence of HIT-antibodies |  | between day 5 and day 14 after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| thromboembolic events |  | up to 21 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIT
Irritable Bowel Syndrome and Low FODMAP Diet

Study Overview
=================
Brief Summary
-----------------
The patients having a syndrome SII would be more intolerant in the fructose than the healthy subjects and would benefit from a fructose diet but also from the fructans which contain some fructose. The intolerance in the fructose is diagnosed thanks to a respiratory test after absorption of fructose. However, the eviction of the fructose is sometimes recommended to the patients without having realized beforehand the test of intolerance.

Detailed Description
-----------------
The main objective is to evaluate the efficacy of the FODMAPS diet on IBS symptoms and to correlate the results with the respiratory test

Official Title
-----------------
Does Irritable Bowel Syndrome Improved by Low FODMAP Diet ?

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Other: Low FODMAPS diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: older than 18, patients with IBS, patients with no organic disorders, patients informed and agreed to participate Exclusion Criteria: patients with sclerodermia, diabetes, obesity, anorexia, colo-rectal surgery, patients with small intestinal bacterial overgrowth, 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low FODMAPS diet and positive breath testing for fructose<br>Patients with breath testing positive have a low FODMAPS diet. The test will be considered as positive if we observe an increase of more than 20 ppm of H2 and/or CH4 on a sample with regard to the basal concentration | Other: Low FODMAPS diet<br>* FODMPAS low diet in patients with IBS and positive breath test for fructose FODMAPS low diet in patients with IBS and negative breath test for fructose<br>|
| Sham Comparator: negative breath testing for fructose<br>patients with negative breath test have a low FODMAPS diet | Other: Low FODMAPS diet<br>* FODMPAS low diet in patients with IBS and positive breath test for fructose FODMAPS low diet in patients with IBS and negative breath test for fructose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fructose expiration rate (ppm) | Estimate the value of the fructose test to predict the efficiency of a diet excluding the fructose and its by-products on the digestive symptoms of the patients having a Syndrome of the irritable bowel. | Day 15 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fructose test
Meir Medical Center Home Monitoring Clinic Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of the registry is to assess workload of a Home Monitoring based follow up for Biotronik ICD and CRTD patients.

Official Title
-----------------
Meir Medical Center Home Monitoring Clinic Registry

Conditions
-----------------
Patients Implanted With an ICD or CRTD.

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Approved indication for ICD or CRTD Implanted with or replaced with a Biotronik Lumax device Patient willing and able to sign consent form Willing and able to attend clinic visits and follow up schedule Transmission of more than 80% at 3-month follow up Patient older than 18 years Exclusion Criteria: no indication for ICD or CRTD implant Life expectancy shorter than 12 months Pregnancy Participation in other clinical studies

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICD, home monitoring, cardiomessenger, implant
Monosodium Glutamate on Gastric Emptying

Study Overview
=================
Brief Summary
-----------------
Children with a radionuclide gastric emptying test with abnormal results will undergo a second test with the addition of a weight adjusted dose of monosodium glutamate. The purpose of the study is to determine if a single dose of monosodium glutamate can shorten the gastric emptying time.

Detailed Description
-----------------
There is evidence that monosodium glutamate has effects on synapsis at the gastric and duodenum level that results in stimulation of contractility resulting on increase rate of gastric emptying. The purpose of the study is to demonstrate that the administration of a single dose of monosodium glutamate can shorten the gastric emptying time. Patients with a prior study indicating a delay of gastric empting time, will undergo a second test with the addition of a weight adjusted dose of monosodium glutamate. Each patient will serve as her/his own control. Results will be analysed by pair-T test.

Official Title
-----------------
Effect of a Single Dose of Monosodium Glutamate on Delayed Gastric Emptying in Children

Conditions
-----------------
Delayed Gastric Emptying

Intervention / Treatment
-----------------
* Dietary Supplement: Monosodium glutamate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children with delayed gastric emptying not receiving prokinetic medication in the last 72 hours Exclusion Criteria: Prior gastrointestinal surgery, patients with known history of reaction to monosodium glutamate. History of neoplasia, autoimmune or inflammatory bowel disease.

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum Age: 17 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: With monosodium glutamate<br>Results of one time gastric emptying study with a single dose of monosodium glutamate; 1 g for weight greater than 45 kg, 700mg between 35 and 44,900 kg, 600mg between 25 and 34,900, 500mg between 15 and 25 kg and 250mg in less than 15 kg | Dietary Supplement: Monosodium glutamate<br>* A single dose of weight adjusted monosodium glutamate will be added at the time of a repeat radionuclide gastric emptying study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduced gastric emptying time | Percentage of reduction of gastric emptying time when glutamate is administered compared to baseline | During the test (4 hours from intake) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
children, monosodium glutamate, delayed gastric emptying