linjc16/ctgov huggingface dataset:
Data on Oral Contraceptives Compliance in Non Stop Regimen

Study Overview
=================
Brief Summary
-----------------
Adherence to the dosing scheme is the principal element of COC efficiency. On the other hand noncompliance seemed to be an inseparable element of any oral treatment. The aim of the study is to evaluate in everyday practice the relation between dosage errors and indicated factors, potentially influencing the compliance with the dosing scheme.

Official Title
-----------------
Observation of Compliance With Dosage in Women Using Oral Contraceptives Designed for the Non Stop Use, (it Means 28 Pills for 28-days Cycle).

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Drug: Qlaira or Yaz (BSP products defined as Combined Oral Contraceptive) and Cerazette or Azalia (competitor's products defined as Progestogen Only Pill)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients at the age of 18-50 requiring contraception, treated with oral contraceptives designed for the scheme 28 pills for 28 days. The decisions would be made at the discretion of the attending physician. Exclusion Criteria: Patients were not valid for analysis if the initial visit was before start of study in the country (retrospective documentation), or if they did not take oral contraceptives designed for the scheme 28 pills for 28 days.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group1<br> | Drug: Qlaira or Yaz (BSP products defined as Combined Oral Contraceptive) and Cerazette or Azalia (competitor's products defined as Progestogen Only Pill)<br>* One tablet per day, orally, 28 tablets per cycle, during three consecutive cycles.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of users showing noncompliant behaviors |  | 3 consecutive cycles (28-days per cycle) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The characteristics of noncompliant behavior. |  | 3 consecutive cycles (28-days per cycle) | 
| The relation between noncompliant behavior and selected factors. |  | 3 consecutive cycles (28-days per cycle) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contraception, Compliance
The Effect of Relaxing Breathing Exercise Applied to Patients Before Bone Marrow Biopsy on Vital Signs, Pain and Anxiety Levels

Study Overview
=================
Brief Summary
-----------------
There is no study in the literature that determined the effect of relaxing breathing exercise applied to patients before the BMB procedure on vital signs, pain and anxiety levels. The aim of this study is to determine the effect of relaxing breathing exercise applied to patients before bone marrow biopsy on vital signs, pain and anxiety levels. hypotheses H1. Relaxing breathing exercise applied to the patients before the bone marrow biopsy procedure reduces the anxiety level of the patients compared to the control group. H2. Relaxing breathing exercise applied to the patients before the bone marrow biopsy procedure reduces the pain level of the patients compared to the control group. H3. Relaxing breathing exercise applied to the patients before the bone marrow biopsy procedure is effective on the respiratory rate of the patients compared to the control group. H4. Relaxing breathing exercise applied to the patients before the bone marrow biopsy procedure is effective on the pulse rate of the patients compared to the control group. H5. Relaxing breathing exercise applied to the patients before the bone marrow biopsy procedure is effective on the blood pressure of the patients compared to the control group.

Official Title
-----------------
The Effect of Relaxing Breathing Exercise Applied to Patients Before Bone Marrow Biopsy on Vital Signs, Pain and Anxiety Levels

Conditions
-----------------
Bone Marrow Cancer

Intervention / Treatment
-----------------
* Behavioral: relaxing breathing exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Being between the ages of 18-65 The fact that a bone marrow biopsy will be performed for the first time Absence of sedative, anxiolytic drug use Absence of a situation that would hinder communication.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breathing Exercise<br> | Behavioral: relaxing breathing exercise<br>* Kumbhaka Pranayama, Sama Vritti Pranayama and box breathing breathing techniques will be applied to the patients.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analouge Scale | After the application, the pain level of the patients is expected to be low. | up to 1 mounth | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bone marrow biopsy, pain, breathing exercise, anxiety
National PROspective Infrastructure for Renal Cell Carcinoma (PRO-RCC)

Study Overview
=================
Brief Summary
-----------------
PRO-RCC is a nationwide long-term cohort for the collection of real-world clinical data, patient reported outcome measures (PROMs) and patient reported experience measures (PREMs) that provides an infrastructure for observational research and (randomized) interventional studies with the TwiCs (Trial within cohorts) design.

Detailed Description
-----------------
PRO-RCC is designed as a multicenter cohort for all Dutch patients with localized RCC or metastatic renal cell carcinoma (mRCC). The clinical data collection is embedded in the framework of the Netherlands Cancer Registry (NCR). Next to the standardly available data on RCC, additional clinical data will be collected. The informed consent for PRO-RCC covers the online collection of PROMs and PREMS, data sharing and data linking with the NCR. PROMS entail Health-Related Quality of Life (HRQoL), symptom monitoring with optional ecological momentary assessment (EMA) of pain and fatigue, and optional return to work- and/or nutrition questionnaires. PREMS entail satisfaction with care. Both PROMS and PREMS are collected through the PROFILES registry and are accessible for the patient and the treating physician. Importantly, participants may also consent to participation in a 'Trial within cohort' studies (TwiC). The TwiC design provides a method to perform (randomized) studies within the registry.

Official Title
-----------------
PROspective Renal Cancer Cohort (PRO-RCC)

Conditions
-----------------
Renal Cancer, Renal Cell Carcinoma, Renal Cell Cancer Metastatic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: newly diagnosed patients with RCC or synchronous metastatic RCC metachronous metastasized RCC age >18 years capable of understanding Dutch language Exclusion Criteria: n/a

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| localized RCC<br>all patients with localized RCC | |
| metastatic RCC<br>all patients with metastatic RCC, synchronous or metachronous | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival | overall survival | 5 years | 
| progression | local or distant recurrence | 5 years | 
| patient reported outcome measures (PROMS) | measured with the EORTC QLQ-C30 questionnaire, every three months in the first year, then yearly up to five years. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported outcomes of adverse events | Measured with the PRO-CTCAE (patient-reported outcomes version of the common terminology criteria for adverse events), weekly during systemic therapy. Symptoms are scored through 0 (absent) to 3 (severe) | 2 years |
Comparison of Two DCCV Algorithms - Rational Versus Maximum Fixed Energy

Study Overview
=================
Brief Summary
-----------------
Direct current cardioversion (DCCV) is a widespread method to restore sinus rhythm in patients with atrial fibrillation. It is a safe and effective method of treating atrial fibrillation. In this study, the investigators want to compare two algorithms. The rational one, with lower initial energy and the second one with the maximum possible shock energy.

Official Title
-----------------
Comparison of Two DCCV Algorithms - Rational Versus Maximum Fixed Energy

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Procedure: Direct current cardioversion (DCCV)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have atrial fibrillation or atrial tachycardia. Patients must be on therapeutic anticoagulation at least three weeks prior to DCCV or undergo esophageal echocardiography to rule out intracardiac thrombus. Patients come on an empty stomach. Patients must be over 18 years of age. Patients must provide verbal and written informed consent to participate in the study. Exclusion Criteria: Omitting oral anticoagulant treatment in the last three weeks. Unclear time of onset of palpitations in acute patients without anticoagulation therapy. A different type of arrhythmia than atrial fibrillation or atrial tachycardia.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rational energy algorithm<br>150 J, 360 J, 360 J biphasic DCCV | Procedure: Direct current cardioversion (DCCV)<br>* DCCV is a safe and effective method of treating atrial fibrillation.<br>|
| Active Comparator: Maximum fixed energy algorithm<br>3x 360 J biphasic DCCV | Procedure: Direct current cardioversion (DCCV)<br>* DCCV is a safe and effective method of treating atrial fibrillation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rhythm after DCCV | sinus rhythm | one minute after DCCV | 
| Incidence of Neurological Adverse Events | neurological complications | two hours after DCCV | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of skin changes | none, skin redness, skin burns | two hours after DCCV | 
| Chest pain | 0-10 scale of pain severity | one day after DCCV | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DCCV, atrial fibrillation
Safety and Efficacy of Bepotastine Besilate Nasal Spray in the Treatment of Seasonal Allergic Rhinitis

Study Overview
=================
Brief Summary
-----------------
This is an efficacy study of bepotastine besilate nasal spray in seasonal allergic rhinitis.

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

Intervention / Treatment
-----------------
* Drug: Bepotastine Besilate Nasal Spray 2% Twice a day
* Drug: Bepotastine Besilate Nasal Spray 3% Twice a day
* Drug: Bepotastine Besilate Nasal Spray 4% Twice a day
* Drug: Placebo Nasal Spray


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female at least 12 years of age with a history of mountain cedar allergy Exclusion Criteria: No active nasal infection or nasal abnormality that would affect subject safety or symptom assessments

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2% Twice a day<br>Bepotastine Besilate Nasal Spray 2% Twice a day | Drug: Bepotastine Besilate Nasal Spray 2% Twice a day<br>* nasal spray<br>|
| Experimental: 3% Twice a day<br>Bepotastine Besilate Nasal Spray 3% Twice a day | Drug: Bepotastine Besilate Nasal Spray 3% Twice a day<br>* nasal spray<br>|
| Experimental: 4% Twice a day<br>Bepotastine Besilate Nasal Spray 4% Twice a day | Drug: Bepotastine Besilate Nasal Spray 4% Twice a day<br>* nasal spray<br>|
| Placebo Comparator: Placebo<br>Placebo nasal spray | Drug: Placebo Nasal Spray<br>* nasal spray<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline (Pre-Dose) in Subject-rated Reflective TNSS | Total nasal symptom score (TNSS) was the summed scores for nasal pruritus [itching], rhinorrhea [runny nose], nasal congestion, and sneezing. Individual nasal symptoms were each rated on a 4-point scale from 0-3 (0=Absent, 1=Mild, 2=Moderate, 3=Severe), with no half-unit assessments. TNSS was the sum score of 4 nasal symptoms with a minimum score of 0 units and a maximum score of 12 units, with higher score corresponding to increased nasal allergy symptoms. Morning and evening scores were averaged. | Baseline, 14 days |
Multi-Site Near Infrared Spectroscopy (NIRS) Monitoring of Children During Tilt Table Testing

Study Overview
=================
Brief Summary
-----------------
PURPOSE OF THE STUDY This study will explore the use of multi-site NIRS monitoring during tilt table testing, combining somatic and cerebral saturations data with hemodynamic data to establish the non-invasive assessment of global cardiac output distribution trends. HYPOTHESIS / SPECIFIC AIMS Study Aims: To evaluate the utility of multi-site NIRS monitoring in the cardiovascular hemodynamic assessment of children and adolescents during tilt table testing by establishing a non-invasive method to predict cardiac output maldistribution with the use of two-site NIRS monitoring in children and adolescents with syncope.

Official Title
-----------------
Use of Multi-site Near Infrared Spectroscopy (NIRS) Monitoring for Hemodynamic Assessment During Tilt Table Testing in Children

Conditions
-----------------
Syncope

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between the ages of 7 and 21 years Referred to the exercise stress lab due to syncope Exclusion Criteria: Under 7 or over 21 years of age Referred to the exercise stress lab for anything other than syncope

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 21 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Children who present to the heart center exercise stress lab for investigation of syncope | |

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
-----------------
Infrared Spectroscopy, Syncope, Tilt Table Testing
Hemochromatosis--Genetic Prevalence and Penetrance

Study Overview
=================
Brief Summary
-----------------
To examine the cost effectiveness of hereditary hemochromatosis (HH) screening in primary care.

Detailed Description
-----------------
BACKGROUND: Hereditary hemochromatosis (HH) is the most common inherited disorder among Caucasians with an estimated frequency as high as 8 per 1000. Affected individuals absorb excessive amounts of dietary iron and develop progressive accumulation of tissue iron stores with consequent organ dysfunction including hepatic cirrhosis, diabetes mellitus, congestive heart failure, arthropathy and impotence. Early diagnosis and institution of phlebotomy treatments will prevent disease manifestations and normalize life expectancy. In 1996, HFE, the gene for HHC was mapped on the short arm of chromosome 6 (6p21.3). HH is therefore a natural target for the development of a routine screening strategy. DESIGN NARRATIVE: The investigators have demonstrated the favorable cost-effectiveness ratio of adopting a screening strategy for HH and have screened 16,031 primary care patients using serum transferrin saturation (TS) levels to confirm the prevalence of undiagnosed HH in this setting and to demonstrate the feasibility of screening. The recent description of HFE gene mutations in individuals with HH has made genetic testing for HH possible and may increase the attractiveness of general screening. However, several important questions about genetic prevalence and penetrance remain to be addressed before such a recommendation can be made. The large screened sample provides a unique opportunity to address several of these important issues. First, they will obtain population-based estimates of the prevalence of HFE gene mutations. Second, they will determine the sensitivity of serum TS testing for detecting these mutations. Third, the comparison of genotype and phenotype will allow them to draw useful inferences about disease penetrance. The results will enable them to propose an optimal screening strategy for HH and to determine the place of genetic testing in the diagnostic algorithm. This strategy may vary depending on age, sex and race. The answers to these questions will enable them to determine with greater confidence the relative effectiveness of a screening strategy for HH and will clarify for primary care practitioners which of their patients should be screened for this disorder. These questions have recently been identified as a priority by the Centers for Disease Control and Prevention and by the National Heart, Lung, and Blood Institute.

Conditions
-----------------
Blood Disease, Hemochromatosis

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- | --- |
Targeted Internal Radiation Therapy in Advanced HCC Patients.

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the 131I-chTNT-1/B treatment effect and safety of individual therapy using randomized controlled study, in order to acquire the evidence of evidence-based medicine and create a new program of targeted internal radiation therapy in advanced HCC patients.

Official Title
-----------------
A Randomized Controlled Prospective Study of Targeted Internal Radiation Therapy in Patients With Advanced Hepatocellular Carcinoma.

Conditions
-----------------
Internal Radiation, Advanced Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Biological: 131I-chTNT-1/B


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Via clinical diagnosis and confirm it is advanced hepatocellular carcinoma mRECIST estimation: necrosis region in HCC Negative iodine allergy test Liver function ：Child-Pugh A/B Exclusion Criteria: reject to attend； impossible to come to our hospital for physical examination regularly. Blood clotting function hindrance; 4, Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction,which may affect the treatment of liver cancer.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: transcatheter arterial chemoembolization<br>Patients will be treated with TACE only. | Biological: 131I-chTNT-1/B<br>* 29.6 MBq/kg,intravenous administration in 1 hour，1-3 course of treatment<br>|
| Experimental: internal radiation group<br>Patients will be treated with TACE combined with internal radiation. | Biological: 131I-chTNT-1/B<br>* 29.6 MBq/kg,intravenous administration in 1 hour，1-3 course of treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Progression |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
131I-chTNT-1/B treatment