linjc16/ctgov huggingface dataset:
Nutritional Status of Cerebral Palsy Patients in Turkey

Study Overview
=================
Brief Summary
-----------------
This is a single visit, non-interventional, cross sectional study about risk factors, etiology, nutritional status and feeding methods in CP patients.

Official Title
-----------------
A Prospective, Cross Sectional Study to Evaluate the Etiology and Nutritional Status of Cerebral Palsy Patients in Turkey

Conditions
-----------------
Nutritional Status

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is greater than/equal to 12 months and less than 19 years of age. Subject is diagnosed with cerebral palsy (CP) by a physician. Exclusion Criteria: Subject presents with genopathies, cardiopathies, hypothyroidism or any pathology not related to CP. Subject is diagnosed with CP of postnatal origin. Subject has other concomitant diagnoses.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 19 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 |
| --- | --- | --- |
| prevalence of malnutrition | physician assessment | at enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| etiology of CP | physician assessment/medical record | at enrollment | 
| correlation between type of CP and nutritional status |  | at enrollment |
Long Term Outcome Women Who Undergone Mid-urethral Sling Surgery

Study Overview
=================
Brief Summary
-----------------
The patients who underwent mid-urethral sling surgery for stress urinary incontinence will evaluate. The aim of our study is to assess long term surgical outcomes and post operative clinical findings include physical examinations, quality of life questionnaires, ultrasonographic measurements.

Detailed Description
-----------------
Patients who underwent mid-urethral sling surgery in Ankara University Obstetrics and Gynecology Department since 2007 will be included. Primary outcome measure is to describe factors effecting long term success in mid-urethral sling surgery.

Official Title
-----------------
Long Term Outcome Women Who Undergone Mid-urethral Sling Surgery Using Urogynecologic Ultrasonographic and Urodynamic Evaluation

Conditions
-----------------
Stress Urinary Incontinence

Intervention / Treatment
-----------------
* Procedure: mid urethral sling surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing surgery in Ankara University Obstetrics and Gynecology Department since 2007 Patients come to follow up Exclusion Criteria: inability in verbal and written communication impairment in cognitive functions
Sexes Eligible for Study
-----------------
Female

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: mid urethral sling surgery|patients with clinically and/or urodynamically proven stress urinary incontinence underwent mid urethral sling surgery under general anesthesia.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective cure rates | Objective cure is negative cough stress test. | 1-11 years | 
| Subjective cure rates | Subjective cure is evaluated with PGI-I instrument. Patients who give 'much better' or 'better' response to the PGI question are considered subjectively cured. | 1-11 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tape localization | Length of urethra, length of mesh, distance between urethra and mesh, distance between mesh and bladder neck will be measured. The correlation between these parameters and surgical success will be evaluated | 1-11 years | 
| Quality of life(QoL) after surgery | Impact of surgery on quality of life will be evaluated by QoL questionnaire | 1-11 years | 
| Patient satisfaction | Patient satisfaction will be assessed using a 10-points Visual Analogue Scale (VAS) that ranged from ''complete achievement of my goal'' (10 points) to ''no achievement of my goal'' (0 points). Patient Global Impression of Improvement (PGI-I) and VAS scale correlation will be evaluated. | 1-11 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trans-Obturator Tape, Tension-Free Vaginal Tape, Mid-Urethral Sling surgeries, Stress Urinary Incontinence
Comprehensive Digital Archive of Cancer Imaging-Radiation Oncology( CHAVI-RO )

Study Overview
=================
Brief Summary
-----------------
In this pilot project Investigators propose to create annotated image data bank of patients suffering from cancer. The system will provide India's first comprehensive platform to upload annotated images with associated medical and demographic information of a patient. It will support flexible query from the users with appropriate choice from a set of attributes and design of various query filters using a GUI. Over the proposed period of 18 months, images and records related to radiation oncology including pretreatment images of at least 500 patients would be annotated and archived in the data bank. The imaging modalities to be covered are X-RAY mammograms, SPECT, CT, CBCT, MR, PET-CT, Ultrasound, digital histopathology, etc. In this phase, this study will include data sets of five types of cancers namely, breast, head and neck, brain, cervix and lung cancer. Investigator propose to demonstrate the application of this data set in cancer research. Investigator will work on serial PET-CT based radiomics of breast and cervix cancer patients to extract appropriate features and correlate them with clinico-pathological variants.

Official Title
-----------------
Comprehensive Digital Archive of Cancer Imaging-Radiation Oncology( CHAVI-RO )

Conditions
-----------------
All Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Patients undergoing radiotherapy planned with volumetric imaging. - Exclusion Criteria: Informed Consent not given
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Main Cohort<br>All patients are undergoing radiotherapy in Tata Medical Center | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with complete data safe. | Count of patients with complete radiological, pathological and demographic information in the CHAVI RO database. | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Artificial Intelligence, Medical Physics, Big Data, Radiation Oncology, Carcinoma, Radiomics, Image Processing, Radiology, Molecular Biology, Data Analytics Center
A Trial on Ultrasound-assisted Spinal Anaesthesia

Study Overview
=================
Brief Summary
-----------------
A randomised controlled trial comparing the use of pre-procedural ultrasound scanning with manual palpation to identify landmarks for performance of spinal anaesthesia.

Official Title
-----------------
A Randomised Controlled Trial on Ultrasound-assisted Spinal Anaesthesia

Conditions
-----------------
Spinal Anaesthesia, Ultrasound

Intervention / Treatment
-----------------
* Procedure: Ultrasound scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I to III undergoing surgery amenable to spinal anaesthesia Exclusion Criteria: Patient refusal contraindications to regional anaesthesia known allergy to local anaesthetics bleeding diathesis inability to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound-assisted<br>Pre-procedural ultrasound scan performed | Procedure: Ultrasound scan<br>* Pre-procedural ultrasound scan was performed<br>|
| No Intervention: Manual Palpation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success Rate of First-attempt of Spinal Anaesthesia |  | During procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Taken to Perform Spinal Anaesthesia |  | During procedure |
Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CTP-543 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
Single- and multiple-ascending dose study of CTP-543 in healthy volunteers.

Detailed Description
-----------------
This two-part study will assess, in healthy volunteers, under fasted conditions, and in a sequential manner, the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single- and multiple-ascending doses of CTP-543.

Official Title
-----------------
A Two-Part Single Center, Randomized, Sequential, Single and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CTP-543 in Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: CTP-543
* Drug: Placebo for CTP-543


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult males and females between 18 and 50 years of age, inclusive Body weight ≥ 50 kg and BMI within the range of 18 to 30 kg/m2, inclusive Exclusion Criteria: History of clinically significant central nervous system (eg, seizures), cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal (GI) conditions PR interval > 220 msec or QRS duration > 120 msec or QTcF interval > 450 msec obtained at screening visit or prior to the first dose of study drug History of herpes zoster Hemoglobin, white blood cell, or platelet levels below the lower reference limit at screening or prior to the first dose of study drug Liver function tests greater than the upper limit of normal Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody Urinalysis positive for protein or glucose A positive screen for alcohol, drugs of abuse, or tobacco use Donation of blood, plasma or other blood products prior to screening A positive tuberculosis test

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CTP-543 Single Dose<br>Single oral dose | Drug: CTP-543<br> <br> Drug: Placebo for CTP-543<br> <br> |
| Experimental: CTP-543 Multiple Dose<br>Multiple oral dose for 7 consecutive days | Drug: CTP-543<br> <br> Drug: Placebo for CTP-543<br> <br> |

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 and Tolerability |  | 24 hours | 
| Measurement of CTP-543 exposure in plasma under fasted conditions |  | 24 hours |
Lifestyle Guidance Methods in NAFLD

Study Overview
=================
Brief Summary
-----------------
To determine the efficiency of lifestyle modification (due to a dietitian or digital application) compared to standard of care.

Official Title
-----------------
The Investigation of Different Guidance Methods to Facilitate Lifestyle Changes in Patients With NAFLD

Conditions
-----------------
Non-Alcoholic Fatty Liver Disease

Intervention / Treatment
-----------------
* Behavioral: Coach
* Behavioral: App
* Other: Standard of care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NAFLD based in FibroScan measurements Exclusion Criteria: excessive alcohol use other causes of liver disease secondary causes of liver steatosis
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 |
| --- | --- |
| Other: Standard of care<br> | Other: Standard of care<br>* Patients will receive standardized lifestyle advice by their specialist<br>|
| Experimental: Lifestyle coach<br> | Behavioral: Coach<br>* Coaching to a healthy lifestyle<br>|
| Experimental: App<br> | Behavioral: App<br>* The app will coach people to a healthy lifestyle<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A change in liver fat | As measured by the controlled attenuation parameter in the intervention arms as compared to standard of care | 1 year |
Metformin in Pregnant PCOS Women

Study Overview
=================
Brief Summary
-----------------
To investigate the effect of metformin on pregnancy complications and pregnancy outcome in the II. and III. trimester of pregnancy in women with polycystic ovary syndrome.

Official Title
-----------------
Metformin Treatment of Pregnant Women With Polycystic Ovary Syndrome (PCOS)

Conditions
-----------------
Polycystic Ovary Syndrome

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-45 years, PCOS diagnosis according to Rotterdam criteria single, viable, ultrasound verified fetus if metformin was used at conception and early pregnancy, at least 7 days of wash out Exclusion Criteria: known liver disease or ALAT > 90 nmol/L known renal disease or creatinine > 110 micromol/L diabetes mellitus alcohol or drug abuse peroral steroid treatment cimetidine, anticoagulant or erythromycin treatment at time of inclusion not suitable for other reasons

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metformin<br>Metformin 1000mg x 2 daily | Drug: Metformin<br>* Metformin 1000 mg x 2 per day. Orally. From inclusion (before gestational week 12) to delivery. Verbal and written diet and lifestyle advices at inclusion to the study<br>* Other names: metformin from Weifa 500 mg / tablet;|
| Placebo Comparator: placebo<br>Placebo x 2 daily | Drug: Placebo<br>* Placebo, 2 tablets x 2 daily.Orally. From inclusion (that is before gestational week 12) to delivery. Verbal and written diet and lifestyle advices at inclusion to the study<br>* Other names: Placebo from Weifa;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational diabetes |  | up to delivery | 
| incidence of metabolic syndrome and neurophysiologic parameters in offspring |  | Within 18 years | 
| Preterm delivery |  | up to delivery | 
| pre-eclampsia |  | up to delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| emesis and hyperemesis |  | up to delivery | 
| Breastfeeding |  | One year post partum | 
| weight change |  | up to delivery | 
| blood pressure change |  | up to delivery | 
| Incident of instrumental deliveries |  | at delivery | 
| Hormone levels in mother and offspring |  | up to delivery | 
| Snoring and sleep quality |  | up to delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCOS, metformin, pregnancy, preeclampsia, diabetes, preterm delivery
Miltefosine Plus IL Pentamidine for Bolivian CL

Study Overview
=================
Brief Summary
-----------------
Bolivian cutaneous leishmaniasis due to Leishmania braziliensis was treated with the combination of miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5).

Detailed Description
-----------------
Bolivian cutaneous leishmaniasis due to Leishmania braziliensis was treated with the combination of miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5). Efficacy and tolerance parameters were assessed. Efficacy was assessed at 1, 3, and 6 months post therapy. Tolerance was assessed on each day therapy was administered.

Official Title
-----------------
Miltefosine Combined With Intralesional Pentamidine for Leishmania Braziliensis Cutaneous Leishmaniasis in Bolivia

Conditions
-----------------
Leishmaniasis, Cutaneous

Intervention / Treatment
-----------------
* Drug: miltefosine plus intralesional pentamidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: one ulcerative lesion ≤ 900 mm2 in total area, ≥ 12 years, parasitologically diagnosed by visualization of amastigotes or culture of promastigotes from lesion material, no antileishmanial therapy in the last 3 months, no mucosal lesions, no history of significant concomitant diseases including immunosuppression. Exclusion Criteria:

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
Intervention Model: Single Group Assignment
Interventional Model Description: Bolivian cutaneous leishmaniasis due to Leishmania braziliensis was treated with the combination of miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5). | Drug: miltefosine plus intralesional pentamidine<br>* miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lesion size | area of lesion | 6 months post therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse effects at site | pain, erythema, edema | days 1, 3, 5 of therapy | 
| systemic adverse effects | gastrointestinal side effects | days 1 to 28 of therapy |
Microscopic Images for the Development of a Rapid Vaginitis Diagnostic Device

Study Overview
=================
Brief Summary
-----------------
The study goal is to create an archive of microscopy images of various vulvovaginal inflammation conditions

Detailed Description
-----------------
During the study, the investigators are planning to make a secondary use of vaginal discharge samples that are primarily taken for routine wet mount microscopic diagnostics in a vulvovaginal clinic at the Women's health center, Ramat-Eshkol, Jerusalem. In order to create an anonymous archive of digital microscopy images, before each swab is disposed of, the investigator will dilute the collected discharge on the swab with 0.5ml Saline into an Eppendorf tube. The diluted discharge will then be applied onto the GynTools LTD VagX tray that is then scanned by a tabletop scanner. At this point the VagX tray will be washed with water, soap and both the swab and tube will be disposed of. No of participating patients: 1000 Patients age: 18 years and above. Only from patients capable of signing an informed consent.

Official Title
-----------------
Archive of Vaginal Swabs Microscopic Images for the Development of a Rapid Vaginitis Diagnostic Device

Conditions
-----------------
Vaginitis

Intervention / Treatment
-----------------
* Other: Vaginal swabs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Vulvovaginal complaints Exclusion Criteria: Younger than 18y or cannot sign an informed consent form

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: Vaginal swabs|The protocol includes the secondary use of vaginal swabs that are primarily used for routine diagnostic assessment in a vulvovaginal clinic|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Creation of microscopy image archive | Collecting 1000 images | 1 year |