linjc16/ctgov huggingface dataset:
Aggressive Squamous Cell Carcinoma in Organ Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
To identify risk factors for aggressiveness in Squamous Cell Carcinoma of the skin in organ transplant recipients.

Detailed Description
-----------------
Squamous Cell Carcinomas (SCC) are one of the most common skin cancers. They belong to the epithelial neoplasm of the skin, which manifest a local aggressive growth and have potential for metastasis. Organ transplant recipients have a hundredfold higher incidence of SCC. Unfortunately the primary tumor, regional nodes, metastasis (TNM)-Classification for the prognosis of SCC in this group of patient has not yet been established. Therefore there are no standardised criteria for evaluation of local recurrence or prognosis. The aim of this study is to identify criteria, which permit a risk assessment relating to aggressiveness of SCC.

Official Title
-----------------
Aggressive Squamous Cell Carcinoma in Organ Transplant Recipients

Conditions
-----------------
Squamous Cell Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Organ transplant recipients with: > 9 SCC in total or > 2 SCC per year (in any one year) or any single index SCC that has a very poorly differentiated cell morphology or that behaved aggressively in Terms of local recurrence or local/systemic metastasis Exclusion Criteria: Non organ transplant recipients
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 |
| --- | --- | --- |
| Diameter of Squamous Cell Carcinoma | Location exact size in mm histological classification (well-differentiated, moderately-differentiated, poorly differentiated, spindle cell morphology, desmoplastic, basi-squamous, acantholytic) Invasion rapid growth local recurrence sentinel node sampling Metastasis | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sun exposure history | skin type hair colour eye colour freckles cumulative UV exposure Measurements will be assessed with questionnaire from about 150 participants. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Squamous Cell Carcinoma
Polysomnography and Heart Rate Indexes in Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the diagnostic accuracy of polysomnography indexes for diagnosis of sleep apnea in human subjects obstructive sleep apnea (OSA). This includes evaluation of polysomnography indexes (AHI; AI, arousal index; ODI, oxygen desaturation index) and heart rate variability (HRV) indexes.

Detailed Description
-----------------
This is a cross-sectional study collecting data from patients from the Sleep Institute of Itaperuna, Rio de Janeiro, Brazil. Polysomnography (PSG) monitoring and diagnosis was in accordance with American Society of Sleep Medicine (ASSM) standards. Standard baseline polysomnography is performed using a computerised system. The following extracted signals are measured: 2 electroencephalogram channels (O1-A2, O2-A1, C3-A2, C4-A1), 2 electrooculogram channels, electromyography (EMG, bilateral anterior tibialis), pulse oximetry (arterial oxygen saturation), nasal-oral airflow (thermistors), and electrocardiogram (ECG derivation DII). The polysomnograms are scored according to the criteria of Rechtschaffen and Kales.

Official Title
-----------------
Polysomnography and Heart Rate Indexes in Obstructive Sleep Apnea

Conditions
-----------------
Obstructive Sleep Apnea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of obstructive sleep apnea with an apnea-hypopnea index (AHI) > 5. Exclusion Criteria: Subjects with a history or clinical examination suggestive of neuromuscular disease, hypertension or any surgical treatment were not considered in the study.

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

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

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 |
| --- | --- | --- |
| Polysomnography indexes | Polysomnography indexes and full-length sleep ECG recordings are extracted from polysomnogram measurements. | one night | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obstructive sleep apnea, polysomnography, heart rate variability, mathematical biomarker
Autologous Fat Graft Alleviate Scar Pain

Study Overview
=================
Brief Summary
-----------------
Traumatic wounds inflict small- and large-fiber sensory nerve damage, causing neuropathic pain in scar tissue. Autologous fat grafting has been clinically shown to improve scar quality, but scantly study has explored its effects on pain. The aim of the study was to survey its effect on pain.

Detailed Description
-----------------
Methods: From February 2008 and June 2013, a total of 36 patients received autologous fat grafting in scar areas. Patients who Douleur Neuropathique 4 Questions (scores >4/10) were enrolled this study. The Visual Analogue Scale (VAS), and Neuropathic Pain Symptom Inventory (NPSI) were used to evaluate pain preoperatively and postoperatively after 1 week, 4 weeks, and 24 weeks. The mechanism of trauma, duration of allodynia, fat graft volume, and total follow-up time were recorded.

Official Title
-----------------
Alleviation of Neuropathic Scar Pain With Autologous Fat Graft

Conditions
-----------------
Scar

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: February 2008 and June 2013, patients received autologous fat grafting in scar areas and also had pain over scar area before surgery Exclusion Criteria: patients refused to participate the study

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 75 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 |
| --- | --- |
| scar, Fat Graft, Visual Analogue Scale<br>patients received autologous fat grafting in scar areas | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale (VAS) |  | preoperatively and postoperatively after 1 week, 4 weeks, and 24 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropathic Pain Symptom Inventory (NPSI) |  | preoperatively and postoperatively after 1 week, 4 weeks, and 24 weeks |
Repeat Insult Patch Test of Skin Irritation/Sensitization for Cetaphil Daily Facial Cleanser

Study Overview
=================
Brief Summary
-----------------
Determine if Cetaphil Daily Facial Cleanser is a contact sensitizer or irritant to the skin

Official Title
-----------------
Cetaphil Daily Facial Cleanser: 200 Human Subject Repeat Insult Patch Test Skin Irritation/Sensitization Evaluation

Conditions
-----------------
Skin Irritation

Intervention / Treatment
-----------------
* Other: Cetaphil Daily Facial Cleanser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Not currently under a doctor's care Free of dermatological or systemic disorder which would interfere with the results Free of any acute or chronic disease Will complete a preliminary medical history form and are in general good health Can read, understand, and sign informed consent Exclusion Criteria: Under 18 years old Currently under doctor's care Currently taking any medication History of acute or chronic disease Diagnosed with chronic skin allergies Pregnant or lactating

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cetaphil Daily Facial Cleanser<br>All subjects receive Cetaphil Daily Facial Cleanser | Other: Cetaphil Daily Facial Cleanser<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| area of erythema and edema to test reaction of skin to product | 9 consecutive 24hr exposures for every Monday, Wednesday, and Friday for 3 consecutive weeks will be conducted to test the reaction of the skin to the test product | 3 consecutive weeks |
Intraocular Lens (IOL) Calculation Improvement

Study Overview
=================
Brief Summary
-----------------
Intraocular Lens (IOL) formulas sometimes differ from expected. Using novel measurement methods before and after cataract surgery improved formulas are tried be developed.

Official Title
-----------------
Intraocular Lens (IOL) Formula Calculation Improvement

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Other: biometry calculation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: older 18 clear cornea cataract

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cataract patients<br>cataract patients | Other: biometry calculation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative refraction (Diopters) |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cataract, refraction, iol, calculation, formula
Epidemiological Features and Clinical Course of COVID -19 Infection in Cancer Patients: The Rovid Study

Study Overview
=================
Brief Summary
-----------------
The study aims to retrospectively collect epidemiological and clinical data in patients with solid tumors and SARS Covid2 infections belonging to oncology centers within the Veneto Oncology Network

Detailed Description
-----------------
The aim of this study is to create a Veneto Oncology Network with the aim of collecting clinical and epidemiological data of cancer Patients affected by SAR- Covid-2 infection over a period of 1 year. Descriptive statistical approaches will be used to process the data. The aim is to evaluate the development rate of severe clinical forms of infection in patients with SARS-Cov-2 and the possible association with tumour characteristics and treatment. In addition, the results of serological tests can be compared with the outcome of the diagnostic swabs and the clinical evolution of the infection in order to obtain more information regarding the significance of specific antibody development.

Official Title
-----------------
Epidemiological Features and Clinical Course of SARS-CoV-2 Infection in Cancer Patients Within the Veneto Oncology Network: the ROVID Study

Conditions
-----------------
Solid Tumor, Adult

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be 18 Years and older cancer patients belonging to Veneto 's Oncological Network Patients with SAR COV-2 infection Exclusion Criteria: Patients with no SAR COV2 Infection Volunteers No Cancer Patients

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cancer Patients with SARS-COV-2 infection.<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of SAR-COV2 infection development in association with tumor characteristics. |  | through study completion, an average of 18 months. |
A Study to Validate Cosmetic Outcome Scales Used to Rate Uneven Skin Color and Wrinkling

Study Overview
=================
Brief Summary
-----------------
Skin chronically exposed to the sun may become damaged and then develop wrinkles and/or uneven skin color. The purpose of this research study is to evaluate a newly developed scale (grading tool) that rates wrinkles and uneven skin color. This newly developed scale will be used in future topical drug studies to measure these changes in the skin.

Official Title
-----------------
A Multicenter Study to Validate Cosmetic Outcome Scales Used to Assess Irregular Skin Pigmentation and Wrinkling

Conditions
-----------------
Skin Wrinkling

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age Exclusion Criteria: Have any disease of the skin, condition, or cosmetics around the eyes that may cause difficulty with the skin assessment using the scale to rate wrinkles and uneven skin color

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Uneven skin color, Wrinkles, Wrinkles and uneven skin color in the area around the eyes
Patient Education in NorthTrondelag Hospital Trust

Study Overview
=================
Brief Summary
-----------------
The purpose of this randomised open study is to examine the effect of self-management program for diabetes patients.

Detailed Description
-----------------
The primary aim in this study is HbA1c in addition to secondary aims like quality of life and coping.

Official Title
-----------------
Patient Education in NorthTrondelag Hospital Trust - Interventions, Effects and Patient Experience

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Behavioral: Lifestyle counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with ICPC-2, code T89 - diabetes dependent on insulin and T90 diabetes not dependent on insulin Exclusion Criteria: Diagnosed with ICPC-2, code T89 - diabetes mellitus juvenile and diabetes I Attended self-management program previous 12 months

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Lifestyle counseling | Behavioral: Lifestyle counseling<br>* Self-management group education<br>* Other names: Self-management;|
| No Intervention: 2<br>Usual care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | Baseline, 6, and 12 mds | 
| PAM - Patient activation measure |  | Baseline, 6, and 12 mds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF36 |  | Baseline, 6, and 12 mds | 
| EQ 5D-VAS scale |  | Baseline, 6, and 12 mds | 
| Hunt diabetes |  | Baseline, 6, and 12 mds | 
| WHO-DTSQ |  | Baseline, 6, and 12 mds | 
| Knowledge of diabetes |  | Baseline, 6, and 12 mds | 
| HDL-cholesterol |  | Baseline, 6, and 12 mds | 
| Total cholesterol |  | Baseline, 6, and 12 mds | 
| Creatinin |  | Baseline, 6, and 12 mds | 
| Blood pressure |  | Baseline, 6, and 12 mds | 
| Weight |  | Baseline, 6, and 12 mds | 
| BMI |  | Baseline, 6, and 12 mds | 
| Cost/benefit |  | Baseline, 6, and 12 mds | 
| Triglyceride |  | Baseline, 6, and 12 mds | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patient Education as a Topic, Self-Management Program, Health promotion, Self Efficacy, Quality of life
Efficacy and Safety of Levocetirizine and Fexofenadine in Reducing Symptoms of Seasonal Allergic Rhinitis

Study Overview
=================
Brief Summary
-----------------
No information was yet available over the effect of levocetirizine in children under 12 years. The aim of this double-blind, placebo-controlled study was to assess the efficacy and safety of levocetirizine in children from 6 to 12 years old with perennial allergic rhinitis due to house dust mites.

Official Title
-----------------
Trial to Compare the Efficacy and Safety of Levocetirizine 5 mg od and Fexofenadine 120 mg od in Reducing Symptoms of Seasonal Allergic Rhinitis in Grass Pollen Sensitized Adults

Conditions
-----------------
Rhinitis, Allergic, Seasonal

Intervention / Treatment
-----------------
* Drug: levocetirizine dihydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults 18 to 55 years both inclusive suffering at least 2 years of seasonal allergic rhinitis due to grass pollen positive RAST and/or positive skin prick test comply with study restrictions Exclusion Criteria: known alcohol or drug addiction or abuse known allergy/intolerance to lactose, cellulose, cornstarch presence of nasal anatomical deformities leading to > 50% obstruction ENT infection within 30 days of the study use of disallowed medication ongoing desensitization known cardiac, renal or hepatic dysfunction presenting allergic bronchial asthma use of cimetidine intending to donate blood during the trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: levocetirizine dihydrochloride|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of the mean Major symptom complex score over the last 2 hours of a 24-hour coverage |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline of the mean MSC score over time interval 3 |  |  | 
| the change from baseline of the mean MSC score over time intervals 1 and 4. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Levocetirizine dihydrochloride, Xyzal tablets
PPI Test in GP Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the diagnostic value of two week treatment with Nexium as a confirmatory test for patients with suspected reflux disease.

Official Title
-----------------
The Proton Pump Inhibitor Test in Reflux Disease: a Study Using Nexium in General Practice Patients

Conditions
-----------------
GERD

Intervention / Treatment
-----------------
* Drug: Esomeprazole
* Procedure: Ambulatory 24-hour esophageal pH-monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Symptoms suggestive for gastric acid reflux disease during 2 or more days per week Exclusion Criteria: Treatment with prokinetic or acid secretion inhibitors within 4 weeks prior to inclusion Treatment with a PPI for more than 30 days within the last 3 months prior to inclusion History of proven peptic ulcer disease, unless successfully treated with Helicobacter pylori eradication longer than 1 month before inclusion

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: Esomeprazole|nan|
|Procedure: Ambulatory 24-hour esophageal pH-monitoring|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic test characteristics and the positive and negative predictive value of a 2-week Nexium-based PPI test using symptom analysis of 24-hour esophageal pH monitoring as gold standard. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the optimal duration of a Nexium-based PPI test, and the predictive value of different symptoms for presence of reflux-related symptoms. |  |  | 
| Obtain information on patient satisfaction, the course of reflux symptoms, the consumption of acid suppressing drugs, the disease-related quality of life at a follow up periods of 3 months in patients with a positive and negative PPI test. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nexium, Gastroesophageal reflux disease, Heartburn, Acid-related diseases, Acid reflux disease