linjc16/ctgov huggingface dataset:
Low-dose Rituximab Regimens in Chinese Adult Patients With Immune Thrombocytopenia

Study Overview
=================
Brief Summary
-----------------
A comparative study with rituximab (100 mg weekly for 4 weeks and 375mg/m2 for once) shows low dose rituximab may be a useful alternative therapy in patients with ITP.The aim of this study is to compare the efficacy and tolerability of two different regimens of low doses rituximab for the treatment of adult patients with ITP.

Detailed Description
-----------------
Hundreds of Patients without infection (age 18 to 60 years old) developed Chronic ITP. All patients will be enrolled in this study and will be randomly assigned to receive 100 mg rituximab weekly for 4 weeks (group A) or a single dose of 375 mg/m2 rituximab (group B). After treatment all patients will be followed for two years. During observation platelet count and B lymphocyte will be detected every month.

Official Title
-----------------
Prospective Multi-center Randomized Controlled Low-dose Rituximab Regimens in Chinese Adult Patients With Immune Thrombocytopenia

Conditions
-----------------
Immune Thrombocytopenic Purpura

Intervention / Treatment
-----------------
* Drug: Rituximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult chronic ITP, age 18 to 60 Exclusion Criteria: pregnant woman with ITP; liver disease and kidney disease; allergy to rituximab

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Experimental: Rituximab A group<br>375mg/m2 for once | Drug: Rituximab<br> <br> * Other names: Trade names Rituxan and MabThera;|
| Active Comparator: Rituximab B group<br>100mg/week for four weeks | Drug: Rituximab<br> <br> * Other names: Trade names Rituxan and MabThera;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the platelet count between two groups given different doses of Rituximab. |  | Patients will be followed for 6 months after Rituximab treatment. |
Metal-on-metal Hip Replacement MRI Study

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to determine the rate of symptomatic and asymptomatic nonmalignant, noninfective soft tissue mass presence (referred to in the literature as pseudotumour, ALVAL, ARMD, cysts or lesions) in primary metal on metal hip replacement patients. The primary objective of the study is to determine the prevalence of masses in unbiased Metal on Metal (MoM) samples drawn from one study centre. The subjects receiving the Metal on Metal devices will be observed at two specific time points. Secondary objectives are to evaluate whether the occurrence of masses is related to any of several potential factors including patient and implant characteristics and time since the implant procedure took place.

Official Title
-----------------
The Rate of Symptomatic and Asymptomatic Non-malignant, Non-infective Soft Tissue Masses in Primary Metal on Metal Hip Replacement.

Conditions
-----------------
Hip Athroplasty Using M2a Magnum

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Patients implanted with the M2a Magnum who were evaluated via MRI and metal ion analysis between 2012 and 2013. Exclusion Criteria: If the primary device was implanted for less than 36 months (in the case of patients already revised) or has been in place for less than 36 months (in the case of patients with the device still in place). If the patient is contraindicated for any of the diagnostic tests. If the patient fails to consent to participating in the 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 |
| --- | --- | --- |
| MRI Scoring change in soft tissue mass size | MRI Score - monitor number and size of soft tissue lesions | 36 months after primary device implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic assessment | Assess acetabular cup inclincation and version | 36 months after primary device implantation | 
| Oxford Hip Score | Oxford Hip Score, score range 0 (worst) to 48 (best) | 36 months after primary device implantation | 
| UCLA Activity Score | UCLA activity scale, range: 1 defined as no physical activity, dependent on others to 10 defined as regular participation in impact sports. | 36 months after primary device implantation | 
| EQ-5D | EQ-5D Index score; Patient Reported Outcome | 36 months after primary device implantation | 
| Metal Ion Levels | Chromium and Cobalt metal ion levels in blood | 36 months after primary device implantation |
Tumor Monitoring Using Thermography During Radiation Therapy

Study Overview
=================
Brief Summary
-----------------
This research aims to investigate the correlation between tumor temperature difference and biological factors, such as size, metabolism, treatment response, and tumor aggressiveness. In addition, normal tissue response to adjuvant radiation therapy in treated organs following surgery, will be evaluated.

Detailed Description
-----------------
During radiation session, the investigators would evaluate the changes that will be detected by thermal imaging and correlate them with visible side effects as well as with known tumor biology factors and skin-tumor distance.

Official Title
-----------------
Tumor Monitoring Using Thermography During Radiation Therapy

Conditions
-----------------
Malignancy

Intervention / Treatment
-----------------
* Other: Thermography imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: signed informed consent will undergo radiation therapy for palliation or curative intent due to cancer, biopsy proven Exclusion Criteria: not eligible to sign informed 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients undergoing radiation<br>In this study, patients undergoing radiation treatment will undergo thermography imaging during radiation treatment course. Patients will be evaluated with thermography imaging every 5 fraction of radiation, starting prior to the first radiation treatment, periodically, until the end of radiation therapy (a period of several weeks). | Other: Thermography imaging<br>* Thermography imaging of the treated - irradiated body area.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of IR : Infra-Red radiation emitted at wavelengths 0.8-1nm | Mathematical analysis of the thermic image | Before the first fraction of radiation and every 5 fraction until the end of radiation therapy, approximately 4-5 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dermal side effects during radiation therapy using CTCAE v4.0 | Clinical assesment of the side effects by physician. | Before the first fraction of radiation and every 5 fraction until the end of radiation therapy, approximately 4-5 weeks. | 
| US/CT scans | The tumor size will be measures to evaluate the efficacy of the radiation treatment. | The tumor size in cubic cm will be mesured prior to first fraction of radiation, and 2 weeks following the end of radiation session. Time for final evaluation: approximately 6-7 weeks. |
Endolumenal Gastric Pouch and Gastrojejunal Anastomosis Reduction

Study Overview
=================
Brief Summary
-----------------
Registry is designed to evaluate use of endolumenal tissue anchors for soft tissue approximation to repair a dilated gastric pouch and gastrojejunal anastomosis in post-Roux-En-Y gastric bypass patients presenting with weight regain. Registry will also assess tissue anchor durability.

Official Title
-----------------
Endolumenal Gastric Pouch and Gastrojejunal Anastomosis Reduction

Conditions
-----------------
Dilated Gastric Tissue

Intervention / Treatment
-----------------
* Device: endolumenal tissue approximation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is > 18 years of age and < 65 years of age Patient is > 2 yrs post-Roux-en-Y bypass surgery Patient initially achieved > 50% EWL after Roux-en-Y bypass surgery Patient is a reasonable risk to undergo general anesthesia Patient is able to provide written informed consent Exclusion Criteria: Patient has an esophageal stricture or other anatomy/condition that would preclude the use and passage of the endolumenal instruments Physician determines another causal factor for weight regain other than stoma or pouch dilation Patient is non-mobile or has significant impairment of mobility that will limit compliance with post-op exercise

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 64 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: endolumenal tissue approximation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Observational Study to Evaluate Safety of Levemir® in Type 1 and Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Asia. The aim of this observational study is to evaluate the incidence of adverse events while using Levemir® under normal clinical practice conditions.

Official Title
-----------------
Observational, Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin detemir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 or type 2 diabetes mellitus Exclusion Criteria: Subjects who are unlikely to comply with the protocol Subjects who are currently being treated with Levemir® Subjects who previously were enrolled into the study Subjects with hypersensitivity to Levemir® or any of its excipients
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br> | Drug: insulin detemir<br>* For study drug, start dose and frequency of administration to be prescribed by the physician as a result of normal clinical evaluation<br>* Other names: Levemir®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of serious adverse drug reactions (SADRs) |  | during treatment | 
| Major hypoglycaemic events |  | during treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of serious adverse events |  | during treatment | 
| Number of all adverse events |  | during treatment | 
| Number of all hypoglycaemic events |  | the last 4 weeks of treatment | 
| Weight changes |  | after 12 weeks | 
| HbA1c |  | after 12 weeks and 26 weeks of treatment | 
| Variability in fasting blood glucose (FBG) and average plasma glucose level |  | after 12 weeks |
The Incidence and Risk Factors of Side Effects During the Initial Phase of Rifater Therapy - a Prospective Study

Study Overview
=================
Brief Summary
-----------------
Tuberculosis remains one of the largest health problems in the world today. Multidrug therapy is necessary to cure tuberculosis patients and to prevent the selection of drug-resistant mutants, however, which may increase the incidence of side effects during the course of treatment. These side effects may be mild as well as fatal. A severe side effect against one of the anti-TB drugs, which influences drug compliance, may lead to the discontinuation of that drug. At the same time, the risk of treatment failure and relapse are higher. Therefore monitoring the rate of anti-TB drugs induced adverse effects and the related risk factors is crucial. Awareness of the risk groups may decrease the incidence of serious drug-related side effects and medical cost. The fixed-dose combinations (FDCs) of tablets against tuberculosis is now being recommended by WHO, which simplify the prescription of drugs and prevent the development of drug resistance. However, the FDC regimen is not consistent with the dosages that are usually given, the higher risk of drug toxicity and adverse reactions should be considered. To our knowledge, there was no report to assess the adverse effects of FDC anti-TB drugs in Taiwan. The aim of the present study is to investigate the current incidence of side effects and the risk factors related to FDC drugs for side effects during the initial phase of therapy.

Conditions
-----------------
Tuberculosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed pulmonary TB and extrapulmonary TB patients No previous anti-TB drugs treatment Age more than 18years old Exclusion Criteria: Expected life < 6months Baseline AST and ALT > 3 fold upper limit of normal (ULN) or total bilirubin>2mg/dl Age less than 18years old

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 |
| --- | --- | --- |
Standardized Application of High Frequency Oscillatory Ventilation in the Acute Respiratory Distress Syndrome (ARDS)

Study Overview
=================
Brief Summary
-----------------
The Acute Respiratory Distress Syndrome (ARDS) is a clinical syndrome of progressive dyspnea and refractory hypoxemia caused by various reasons. Although in recent years a variety of supportive care measures have significant progress, but the mortality rate of patients with ARDS is still as high as 35-40%. Mechanical ventilation is one of the main treatments with ARDS, which is widely used in clinical. The rational mechanical ventilation strategy can improve the oxygenation of patients with ARDS and reduce lung injury. Patients with ARDS usually have alveolar epithelial and pulmonary capillary endothelial injury, and the lesion has heterogeneity. The protective mechanical ventilation strategies chosen by patients with ARDS in clinical practice are gradually being accepted and applied. The High-frequency oscillatory ventilation (HFOV) is a ventilation way with high respiratory rate and low tidal volume. Compared with conventional mechanical ventilation, HFOV may be able to more effectively improve oxygenation and reduce ventilator-associated lung injury. HFOV and protective ventilation strategy in ARDS is consistent with an important position in the treatment of ARDS, but not been widely adopted in clinical practice and is still only as a salvage treatment. Therefore, this study intends to use HFOV treatment with conventional mechanical ventilation by matching the cases in patients with ARDS. By comparing the influences of the patient's condition and mortality with HFOV, the clinical efficacy, safety, and health economics effectiveness of HFOV are further investigated and adaption time and parameter settings of HFOV are explored, which provide better treatment options for patients with ARDS and improve their prognosis.

Conditions
-----------------
Acute Respiratory Distress Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age> 18 years; lung protective ventilation (tidal volume 4-6ml/kg), airway plateau pressure is still higher than 30cmH2O, or the failure of conventional mechanical ventilation pneumothorax, bronchopleural fistula in patients with ARDS; of ARDS diagnosis in line with the 2012 Berlin ARDS diagnostic criteria. be able to sign informed consent. Exclusion Criteria: severe pulmonary hemorrhage; severe intracranial high pressure; large airway stenosis and airway obstruction.

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
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safety, Clinical efficacy, of HFOV treatment, of patients
Cryoballoon Atrial Fibrillation Ablation Registry

Study Overview
=================
Brief Summary
-----------------
This is a prospective registry of atrial fibrillation cryoablation in the Russian Federation. This study is observational, prospective, multicenter, open-label

Detailed Description
-----------------
The purpose of this Registry is to describe characteristics of patients undergoing cryoballoon ablation, diversity of cryoablation techniques among different centers; to evaluate efficacy and safety of the procedure in the centers with different levels of experience.

Official Title
-----------------
Prospective Registry of Atrial Fibrillation Cryoballoon Ablation in the Russian Federation

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The indications for catheter ablation of atrial fibrillation Signed informed consent to participate in the Register Patients undergoing cryoballoon ablation Exclusion Criteria: Left atrial thrombosis
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 |
| --- | --- | --- |
| Freedom from arrhythmia: Number of participants with no evidence of atrial achyarrhythmia longer than 30 s, as detected by regular ECG monitoring | ECG monitoring will be performed in accordance with sites' routine practices (Holter monitoring every 3 months, implantable loop recorder, cardiac rhythm management device interrogation, other regular ECG screening) | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events that are related to treatment (i.e. cardiac tamponade, periprocedural stroke, pulmonary vein stenosis, esophageal damage, etc) |  | 1 Year | 
| Number of participants with adverse events that are related to underlying disease (cardiovascular events not related to atrial fibrillation cryoablation) |  | 1 Year | 
| Atrial fibrillation procedure characteristics: Mean total ablation procedure time in minutes, mean fluoroscopy time in minutes (during the ablation procedure) | Data will be collected using a web-based system of electronic case report forms | Above parameters will be assessed only during the procedure of cryoablation | 
| Number of participants with antiarrhythmic drug treatment at 12 months |  | 1 Year |
Impact of Art Therapy on Anxiety Identified During Hospitalizations Among Children With Cystic Fibrosis Aged 8 to 13

Study Overview
=================
Brief Summary
-----------------
Currently the management of cystic fibrosis (CF) patients is mainly based on symptomatic treatments. The arrival of children in day hospital, every 2 to 3 months, is for many of them and those around them, stressful, rarely expressed, but noticeable by the care team. In line with the recommendations of the High Authority of Health, the multidisciplinary team of Resources and Skills Centre for Cystic Fibrosis (CRCM) Pediatric of Nantes University Hospital offers a therapeutic education program tailored to the needs of children with cystic fibrosis and their families . The aim is to support children and parents in the acquisition of self-care skills (knowledge and skills) and coping skills, such as managing stress and emotions . Our goal is to demonstrate that art therapy, mobilizing coping skills of the child, facilitates its expressive capabilities and reduces anxiety.

Official Title
-----------------
Impact of Art Therapy on Anxiety Identified During the Quarterly Update of Hospitalizations Among Children With Cystic Fibrosis Aged 8 to 13 - Pilot Study

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Other: Non interventional Study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with CF aged 8 to 13 years as part of their monitoring at CRCM children of Nantes University Hospital Parents and children willing to participate in research Non inclusion Criteria: Emergency consultation Planned move

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 13 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Non interventional Study|Parents and children will be informed at the inclusion visit (V0) that is a normal consultation under the care of the child. The children included will be followed for 18 months with a maximum of 6 months without meeting art therapy sessions and 12 months with art therapy. The art therapy sessions will be scheduled during the usual consultations conducted as part of the care of children. At each visit, clinical, paraclinical and external factors of anxiety will be collected and anxiety of parents and children will be measured using specific questionnaires.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the overall score of children's anxiety after 4 visits including art therapy sessions compared to basal mean level of the first two visits without art therapy. |  | Up to 18 months |