linjc16/ctgov huggingface dataset:
Study of Tomotherapy HD in Medulloblastoma

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to improve local control and long-term survival in children with medulloblastoma, reduce the side effects of treatment and improve quality of life.

Detailed Description
-----------------
The technical advantages of Tomotherapy HD in the radiotherapy of children medulloblastoma (advantages in clinical operation and physics) were transformed into clinical advantages, and the possible mechanisms were explored.

Official Title
-----------------
Study of Tomotherapy HD in Medulloblastoma

Conditions
-----------------
Medulloblastoma

Intervention / Treatment
-----------------
* Device: Tomotherapy HD
* Device: 3DCRT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient was diagnosed as myeloblastoma by surgical pathology with definite pathological classification. MRI of the head and spinal cord before and after operation, with definite staging; Radiotherapy was performed within 28 days after surgery. Exclusion Criteria: Previous radiotherapy in the whole brain, whole spinal cord or primary focus; Postoperative radiotherapy for more than 28 days.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum 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 |
| --- | --- |
| Active Comparator: 3DCRT<br>This arm will be planned by 3DCRT to the treatment of the Medulloblastoma | Device: 3DCRT<br>* Patients with Medulloblastoma receiving Three-Dimensional Conformal Radiation Therapy<br>|
| Experimental: Tomotherapy HD，TOMO<br>This arm will be planned by TOMO to the treatment of the Medulloblastoma | Device: Tomotherapy HD<br>* Patients with Medulloblastoma receiving Tomotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QoL(quality of life) | Changes in quality of life were assessed by EORTC QLQ-C30 | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS (progression free survival) | from the first day of therapy to the date of disease progression or death from any cause, whichever was first (according the criterion of RECIST 1.1 ). | 2 years | 
| OS (overall survival) | from the first day of therapy to death or last follow-up | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TOMO irradiation
Efficacy Pilot Study of Triflusal in the Attenuation of Insulin Resistance in Human Obesity

Study Overview
=================
Brief Summary
-----------------
To explore the efficacy of triflusal in the attenuation of insulin resistance in human obesity. Triflusal is a salicylate compound approved in several countries as antithrombotic agent (antiplatelet). The hypothesis is to explore if there is a reduction of obesity-induced insulin resistance by triflusal.

Detailed Description
-----------------
Double-blind, randomized, cross-over (three periods) with two dose levels of triflusal, placebo-controlled. Interventions: treatment periods Triflusal 600 mg/d, 15 days Triflusal 900 mg/d , 15 days placebo, 15 days Washout period: 30 days

Official Title
-----------------
Phase IIa Study of Triflusal in the Attenuation of Insulin Resistance in Men and Woman With Obesity

Conditions
-----------------
Insulin Resistance

Intervention / Treatment
-----------------
* Drug: Triflusal (DCI)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 35 to 60 years old

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 60 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Triflusal (DCI)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase of insulin sensitivity in apparently healthy men and woman evaluate by means of i.v. glucose tolerance test (PTEVGMR). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction antropometric measures associated with insulin resistance and arterial hypertension. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
insulin resistance and inflamation, insulin sensitibity, obesity-induced insuline resistence, obesity-diabetes link, salicylate, insulin resistance in obesity health adults
Effect of Intraperitoneal Nebulisation of Magnesium Sulphate for Analgesia Following Laparoscopic Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
intraperitoneal nebulisation with magnesuim sulphate will reduce post operative pain and analgesic consumption in postoperative period following laparoscopic cholecystectomy.

Detailed Description
-----------------
Sixty patients undergoing laparoscopic cholecystectomy belonging to American Society of Anaesthesiologist (I-II) of age 18-65 yrs will be enrolled.Group one (n=30) will receive 1.5 gm magnesium sulphate diluted in 3ml of normal saline and group 2 (n=30) will receive 5 ml of NS.

Official Title
-----------------
Phase IV Recruiting

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: intraperitoneal nebulisation of magnesium sulphate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-II - Exclusion Criteria: history of -

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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Magnesium sulphate<br>intraperitoneal nebulisation of 1.5 gm of magnesium sulphate with 2 ml of normal saline at the end of surgery before closure | Drug: intraperitoneal nebulisation of magnesium sulphate<br>* intraperitoneal nebulisation of 1.5 gm of magnesium sulphate with 2 ml of normal saline<br>|
| Placebo Comparator: normal saline<br>intraperitoneal nebulisation of 5 ml of normal saline after end of surgery before closure | Drug: intraperitoneal nebulisation of magnesium sulphate<br>* intraperitoneal nebulisation of 1.5 gm of magnesium sulphate with 2 ml of normal saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of analgesic request | time to first analgesic request is taken as duration of effective analgesia number of analgesic request in first 24 hours were also counted | 24 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS score | Visual analogue scale is a linear 10cm scale with 0 corresponding to no pain and 10 to worst pain ever | first complaint of pain, 6 hrs, 12 hrs, 24 hrs | 
| nausea and vomiting |  | 24 hrs | 
| respiratory rate |  | 24 hrs | 
| sedation |  | 24hrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
magnesium sulpahate, postoperative analgesia
Evaluation of the Strip PeriScreen for the Fast Diagnosis of the Spontaneous Infection of the Liquid of Ascites During the Cirrhosis

Study Overview
=================
Brief Summary
-----------------
The forecast of the spontaneous infection of the liquid of ascites (ISLA) at the cirrhotic patient is still burdened by a heavy mortality. The fast diagnosis of the ISLA is thus an essential stake to improve the forecast. Investigators would so like to estimate the interest of the strip PeriScreen for the fast diagnosis of the ISLA at cirrhotic patients . Investigators plan to include 670 patients, what would allow to make out a will at least on ascites 2000 on about twenty centers for duration estimated of 12 months.

Official Title
-----------------
Evaluation of the Strip PeriScreen for the Fast Diagnosis of the Spontaneous Infection of the Liquid of Ascites During the Cirrhosis

Conditions
-----------------
Cirrhosis, Liquid of Ascites, Infection

Intervention / Treatment
-----------------
* Other: strip Peri Screen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female over 18 years Presence of ascites due to cirrhosis Hospitalization for a complication of cirrhosis (ascites first decompensation, gastrointestinal bleeding, encephalopathy, etc ...). or Hospitalization to perform a paracentesis evacuated outpatient Patients on long-term antibiotic primary or secondary prophylaxis the spontaneous bacterial peritonitis and with clinical and/or biological signs that suggest spontaneous infection of ascite. Exclusion Criteria: Patients with ascites urgently admitted to hospital for suspected infection receiving antibiotics for more than 12 hours. chylous ascites, Hemorrhagic Ascites Biliary Ascites (straw) Ascites heterogeneous appearance Ascites not related to portal hypertension (peritoneal carcinomatosis, pancreatic ascites, tuberculosis, etc ...) Patient receiving imipenem IV. Patients on long-term antibiotic primary or secondary prophylaxis the spontaneous bacterial peritonitis without clinical and/or biological signs that suggest spontaneous infection of ascite.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: strip Peri Screen<br> | Other: strip Peri Screen<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| liquid of ascites spontaneous infection | Periscreen strip compared to the cytological analysis | Baseline |
Combination of NHF and Nebulizer on Lung Function in COPD

Study Overview
=================
Brief Summary
-----------------
This study will prove to concept of effectiveness of NHF in combination with a nebulizer on reversibility of lung function in COPD patients.

Detailed Description
-----------------
Patients will inhale on day 1 with a nebulizer and on another day with combination of nebulizer an NHF in a randomised order.

Official Title
-----------------
Effect of Nasal Highflow in Combination With a Nebulizer on Reversibility in Lung Function in Patients With COPD

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Device: Nasal high flow (NHF)
* Device: Nebulizer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stable disease COPD Exclusion Criteria: exacerbation right heart decompensation acute respiratory insufficiency acute disease
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: inhalation with nebulizer<br>inhalation with an nebulizer via mouth | Device: Nebulizer<br>* Inhalation will be done will Nebulizer and via mouth<br>|
| Active Comparator: inhalation with nebulizer and NHF<br>inhalation with combination of nebulizer and nasal high flow (NHF) via nasal cavity | Device: Nasal high flow (NHF)<br>* NHF will be combinated with a nebulizer. Inhalation will be done on nasal cavity.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in forced expiratory volume in 1s (FEV1) | litre | 45 minutes | 
| changes in breath way resistance (Rtot) |  | 45 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NHF, nasal highflow
Effect of 25-OH-vitamin D3 on the Liver Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
The low vitamin D3 levels and malnutrition before liver transplantation showed an increase in the length of stay in ICU and hospital. Although several factors may influence the clinical outcomes of patients with liver transplantation, low vitamin D3 levels showed an independent risk factor. It is necessary to prospectively analyze the effect of vitamin D supplements on clinical outcomes in liver transplant recipients.

Detailed Description
-----------------
Purpose: Vitamin D deficiency is common in patients of chronic liver disease and has been associated with infection and mortality. The aim of this study is to determine whether preoperative vitamin D levels affect clinical outcomes after liver transplantation. Methods : This was a single-center retrospective study. Between June and November 2017, a total of 219 patients underwent liver transplantation. The primary outcome was the relationship between serum 25-OH-vitamin D3 level before liver transplantation and length of stay in the intensive care unit (ICU). Secondary outcomes included the duration of normalization of inflammatory marker, such as white blood cell count (WBC) & C-reactive protein (CRP) after liver transplantation, new infection rates, rejection rates, the length of hospital stay and mortality among vitamin D level.

Official Title
-----------------
The Clinical Effect of Preoperative Level of 25-OH-vitamin D3 on the Liver Transplant Recipients

Conditions
-----------------
Liver Transplant Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients who admitted to intensive care unit (ICU) after liver transplantation were studied Exclusion Criteria: Patients who didn't have preoperative vitamin D level

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 |
| --- | --- |
| 1<br>Liver transplant patients with severe vitamin D deficiency (<10ng/ml) | |
| 2<br>Liver transplant patients with vitamin D insufficiency (10-20ng/ml) | |
| 3<br>Liver transplant patients with normal vitamin D status (>20ng/ml) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital stay after liver transplant | compared with each group | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of normalization of CRP, WBC | compared with each group | 6 months | 
| Length of ICU stay | compared with each group | 6 months | 
| New infection rate | compared with each group | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitamin D, liver transplant, hospital stay
Efficacy of Adhesive Tablets in Treating Oral Ulcers (Aphthous)

Study Overview
=================
Brief Summary
-----------------
Recurrent Aphthous Stomatitis (RAS) of the oral mucosa is a common and painful condition. Despite advances in therapeutic means there is still necessary to find a way to alleviate the local pain and discomfort induced by the mucosal ulceration. The hypothesis was to study the effectiveness and acceptance of a herbal adhesive tablets in the treatment of RAS. Participants in the study will be examined for oral lesions, will be instructed how to apply the oral-tablet, and will be interviewed during the follow-up period up to one week after the application.

Official Title
-----------------
Phase 2 Study of Efficacy of Adhesive Tablets in Treating Oral Ulcers (Aphthous)

Conditions
-----------------
Ulcer, Aphthous

Intervention / Treatment
-----------------
* Drug: Pro-Pe adhesive tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (in healthy individuals): Age above 18 years old. Non-pregnant women. Healthy or controlled chronic diseases. Examination at the Oral Medicine Clinic Inclusion Criteria (in RAS patients): Age above 18 years old. Non-pregnant women. Clinical diagnosis of RAS. Examination at the Oral Medicine Clinic Exclusion Criteria: Oral lesion suspected to be malignant. Ulcerative oral lesion other than RAS. Another experimental oral intervention within the last 24 hours. Pregnant women. Allergy to components of the Pro-pe adhesive tablet

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

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

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: Pro-Pe adhesive tablet|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serial questionnaires within 1 week post treatment to assess patient's perception, patient's pain relief and local adverse events in comparison to his past experience with other local treatments for oral ulcers. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aphthous, oral
Effects on the Personalized Rehabilitation Service in Patients With Cancer

Study Overview
=================
Brief Summary
-----------------
In order to study the effectiveness of personalized healthcare service program for breast cancer rehabilitation, investigators designed this study using mobile phone and clinical intervention(feedback coaching).

Official Title
-----------------
Effects on the Personalized Rehabilitation Service in Patients With Cancer

Conditions
-----------------
Breast Cancer, Lymphedema, Breast Neoplasms, Breast Cancer Female

Intervention / Treatment
-----------------
* Behavioral: Personalized health care service


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Breast cancer patient (age over 18), Cancer stage under 3, Android OS smartphone user Exclusion Criteria: Cancer stage over 4, Patients diagnosed with multiple cancer, Patient who cannot participate rehabilitation exercise program

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Personalized rehabilitation service group<br>Breast cancer patients who use mobile healthcare service application and receive personal feedback from clinician | Behavioral: Personalized health care service<br>* Personalized health care service, such as rehabilitation exercise recommendation, lifestyle activity coaching, health data monitoring<br>|
| No Intervention: Conventional group<br>Breast cancer patients with conventional care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient health ability change | Measuring Health and Disability WHODAS 2.0 | Baseline and after 4 weeks, 8 weeks of lifestyle modification | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lab test result change | Laboratory test (Blood test) | Baseline and after 4 weeks, 8 weeks of lifestyle modification | 
| Patient satisfaction change on mobile service | Patient subjective evaluation by survey on satisfaction | Baseline and after 4 weeks, 8 weeks of lifestyle modification | 
| Patient satisfaction change on healthcare management | Patient subjective evaluation by survey on satisfaction | Baseline and after 4 weeks, 8 weeks of lifestyle modification |