linjc16/ctgov huggingface dataset:
Prevention Chemotherapy Induced Mucositis by Zinc Sulfate

Study Overview
=================
Brief Summary
-----------------
In this double blinded randomized study we evaluate effect of Zinc sulfate for prevention mucositis due to high dose chemotherapy in the patients undergoing bone marrow transplantation whose received Busulfan and/or Cyclophosphamide. Patients randomized in two groups: intervention and control with balanced block randomization method. Intervention group received Zinc sulfate immediately after start conditioning regimen and continued for two weeks. Control group received placebo at the same manner. Prevalence and severity of mucositis will be compared in two groups.

Official Title
-----------------
Prevention High Dose Chemotherapy Induced Mucositis by Using Zinc Sulfate

Conditions
-----------------
Mucositis, Bone Marrow Transplantation

Intervention / Treatment
-----------------
* Drug: Zinc Sulfate
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient undergoing bone marrow transplantation Signed informed consent Exclusion Criteria: Unable take drug (or placebo) orally
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: Intervention<br>Received Zinc Sulfate | Drug: Zinc Sulfate<br>* Zinc Sulfate: 100 mg of zinc element, per day, bid for two weeks start with chemotherapy<br>|
| Placebo Comparator: Control<br>Control group | Drug: Placebo<br>* Placebo: as the same of intervention group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of Zinc Sulfate on prevention of mucositis in patients undergoing bone marrow transplantation |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Zinc Sulfate concentration |  | 1 year | 
| Evaluation of Zinc Sulfate advance effects |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mucositis, Bone Marrow Transplantation, BMT, HSCT
Association of Non-alcoholic Fatty Liver Disease and Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the association of non-alcoholic fatty liver disease and diabetes mellitus. Patients presenting in our clinic with Diabetes mellitus type 1 or 2 will receive the following examination: Transient Elastography and Controlled Attenuation Parameter using the FibroScan blood examination including biochemical markers The statistically calculated sample size needed is 340 patients.

Official Title
-----------------
Association of Non-alcoholic Fatty Liver Disease and Diabetes Mellitus

Conditions
-----------------
Non-alcoholic Fatty Liver Disease (NAFLD)

Intervention / Treatment
-----------------
* Device: Controlled Attenuation Parameter (CAP), Echosens, Paris, France
* Device: FibroScan, Echosens, Paris, France


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, 18 years and older Written informed consent Diabetes mellitus type 1 or 2 Exclusion Criteria: Patients with mental diseases Pregnancy or lactation Ascites Continued alcohol consumption (> 21 drinks/week for male and > 14 drinks/week for female patients) Chronic liver disease (viral hepatitis, autoimmune hepatitis, PBC, PSC, hemochromatosis, M Wilson) Hepatocellular carcinoma/ Liver metastasis

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

| Intervention/Treatment |
| --- |
|Device: Controlled Attenuation Parameter (CAP), Echosens, Paris, France|nan|
|Device: FibroScan, Echosens, Paris, France|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Steatosis | • Evaluating the presence of liver steatosis in patients with diabetes mellitus using the ultrasound-based method Controlled Attenuation Parameter, which is integrated in the FibroScan machine and can non-invasively quantify liver steatosis (Steatosis fibrosis scores I-III [ Designated as safety issue: No ]; Steatosis scores: 0 = <5% I = 5-33% II = 33-66% III = >66%) | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibrosis | • Evaluation of the prevalence of liver fibrosis using transientelastography (FibroScan) and serological markers in patients with diabetes mellitus (Liver fibrosis scores I-IV (METAVIR) [ Designated as safety issue: No ]; METAVIR fibrosis scores: I = mild fibrosis II = significant fibrosis III = advanced fibrosis IV = cirrhosis) | one day | 
| Steatosis (serum) | • Evaluating the prevalence of liver steatosis using serum steatosis markers in patients with diabetes mellitus | one day |
FCH PET/MRI Parathyroid Localization

Study Overview
=================
Brief Summary
-----------------
A prospective trial comparing the accuracy of [F-18]-FCH PET/MRI to US and 99mTc-MIBI SPECT/CT for pre-operative parathyroid localization in patients with primary hyperparathyroidism

Official Title
-----------------
18F-Fluorocholine PET/MRI for the Localization of Parathyroid Adenomas

Conditions
-----------------
18F-fluorocholine, Positron-Emission Tomography, Hyperparathyroidism, Primary

Intervention / Treatment
-----------------
* Diagnostic Test: [F-18]-FCH PET/MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Biochemically proven primary hyperparathyroidism Indication for parathyroidectomy as per institutional guidelines Exclusion Criteria: Contraindication for MRI as per current institutional guidelines. Contraindication for Gadolinium injection as per current institutional guidelines. Renal failure Inability to lie supine for at least 45 minutes. Any participant who is pregnant or breastfeeding. Participants receiving erythropoietin (i.e. for hemochromatosis; might lead to false negative results due to stimulation of bone marrow metabolism) Familial HPT syndromes Participant currently being treated with any cytotoxic chemotherapy

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 |
| --- | --- |
| Experimental: [F18]-FCH PET/MRI<br>Patients with primary hyperparathyroidism planned for parathyroidectomy | Diagnostic Test: [F-18]-FCH PET/MRI<br>* Subjects will undergo the [F-18]-FCH PET/MRI within three months prior to scheduled parathyroidectomy.<br>* Other names: Fluorine-18 fluorocholine PET/MRI;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of [F-18]-FCH PET/MRI in localization of diseased parathyroid gland | Value of [F-18]-FCH PET/MRI next to Ultrasound of the Neck and 99mTc-MIBI SPECT/CT in determining which of the four parathyroid glands Reference standards: Intra-operative location of the hyper functioning gland by inspection and post-operative pathological confirmation. Determination of biochemical cure per usual standard of care: intraoperative PTH and calcium and PTH postoperatively. | 1 month postoperatively |
The Effects of Preoperative and Postoperative Oral Nutritional Supplements in Malnourished Post-gastrectomy Patients

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the effect of a perioperative nutrition strategy using oral nutritional supplements (ONS) on postoperative complications and improvement in body weight in malnourished patients who underwent gastrectomy.

Official Title
-----------------
A Prospective Randomized Controlled Trial Evaluating the Effects of Preoperative and Postoperative Oral Nutritional Supplements (ONS) in Malnourished Post-gastrectomy Patients

Conditions
-----------------
Malnourished, Stomach Neoplasms, Gastrointestinal Stromal Tumors

Intervention / Treatment
-----------------
* Dietary Supplement: Ensure powder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 20 years Patients who undergo distal, total, proximal, or pylorus-preserving gastrectomy Patients who are assessed as moderate or severe malnourished according to PG-SGA or patients with BMI lower than 18.5 kg/m2 Patients who can take oral meals Patients who agree on the informed consent Exclusion Criteria: Emergent operation Patients who received preoperative chemotherapy or radiation therapy within 6 months Pregnant patients Patients who cannot consume the Ensure powder Patients who enrolled another clinical trials

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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 |
| --- | --- |
| Active Comparator: Ensure powder<br>Oral Nutritional Supplements with carbohydrate, lipid, protein, vitamin and minerals | Dietary Supplement: Ensure powder<br>* Ensure powder(500kcal) per day for 7 weeks<br>* Other names: Ensure powder (Abbott);|
| No Intervention: Standard care<br>Standard care without oral nutritional supplements | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complication rate |  | 7weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight |  | 7weeks | 
| Body composition indices |  | 7weeks | 
| Length of hospital stay |  | 7weeks | 
| Quality of life |  | 7weeks | 
| Postoperative 30-day mortality |  | 7weeks | 
| Biochemical assessment of nutritional status |  | 7weeks | 
| Readmission rate |  | 7weeks | 
| Patient compliance of oral nutritional supplements |  | 7weeks |
Oral Cancer Screening and Education in Hong Kong

Study Overview
=================
Brief Summary
-----------------
This study will be conducted to obtain data on oral cancer risk factors to generate machine learning models with good predictive accuracy for stratifying individuals with high-oral cancer risk and delineating high-risk and low-risk oral lesions. Likewise, this study will seek to provide oral cancer-related health education and training on oral-self-examination for beneficiaries

Official Title
-----------------
THE HONG KONG ORAL CANCER EDUCATION AND SCREENING (HOCES) PROGRAM: REFINING DISEASE PREVENTION, RISK STRATIFICATION AND EARLY DETECTION

Conditions
-----------------
Oral Cancer, Oral Leukoplakia, Oral Submucous Fibrosis, Proliferative Verrucous Leukoplakia, Oral Erythroplakia, Erosive Lichen Planus

Intervention / Treatment
-----------------
* Other: No intervention utilised


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy individuals satisfying age and residential area criteria with no previous history of oral cancer. Individuals with a history of other cancers will be included in the study provided they have been in remission for more than three years. Exclusion Criteria: Participants with reduced mouth opening (irrespective of the cause) to permit proper administration of VOE or photosensitive epilepsy will be excluded. Likewise, those who decline the provision of written consent or participation in any part of the study.

Ages Eligible for Study
-----------------
Minimum Age: 45 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 |
| --- | --- |
| Tobacco use and/or alcohol consumption<br> | Other: No intervention utilised<br>* No intervention utilised<br>|
| No tobacco use and/or alcohol consumption<br> | Other: No intervention utilised<br>* No intervention utilised<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of machine learning algorithms for predicting high-risk persons | Predictive accuracy of the ML classifiers for forecasting individuals with or likely to develop high-risk lesions within 24 months of first screening encounter based on demographic and lifestyle information. | 24 months | 
| Accuracy of machine learning algorithms for discriminating high-risk and low-risk lesions | Predictive accuracy of ML classifiers for classifying high-risk and low-risk lesions based on demographic and lifestyle risk factors, oral high-risk HPV status, and salivary DNA hypermethylation levels. | 24 months |
Measure Exposure Of Tanezumab In Healthy Volunteers When Administering The Drug Subcutaneously

Study Overview
=================
Brief Summary
-----------------
The hypothesis of this study is that subcutaneous administration of tanezumab results in lower drug exposure compared to intravenous administration of tanezumab.

Official Title
-----------------
Pharmacokinetics And Safety Of A Single Dose Subcutaneous Or Intravenous Administration Of Tanezumab In Healthy Volunteers: An Open-Label, Non-Randomized Phase 1 Study

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Biological: tanezumab
* Biological: tanezumab
* Biological: tanezumab
* Biological: tanezumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Generally healthy BMI of 18-30 kg/m2 more than 50 kg bodyweight. Exclusion Criteria: Pregnant exposure to biologic type drugs within the last 3 months history of allergic or anaphylactic reaction to a biologic drug use of tobacco- or nicotine containing products that is more than what is in 5 cigarettes per day excessive alcohol use.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 10 mg IV<br> | Biological: tanezumab<br>* Drug solution given intravenously only once at dose of 10 mg<br>|
| Active Comparator: 5 mg SC<br> | Biological: tanezumab<br>* Drug solution given subcutaneously only once at dose of 5 mg.<br>|
| Active Comparator: 10 mg SC<br> | Biological: tanezumab<br>* Drug solution given subcutaneously only once at dose of 10 mg.<br>|
| Active Comparator: 19 mg SC<br> | Biological: tanezumab<br>* Drug solution given subcutaneously only once at dose of 19 mg.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subcutaneous bioavailability |  | 16 weeks | 
| Injection site reactions |  | 16 weeks | 
| Immunogenicity |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nerve growth factor levels |  | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacokinetics tanezumab subcutaneous bioavailability intravenous Japanese subjects
Gum Chewing After Gynecologic Laparoscopy

Study Overview
=================
Brief Summary
-----------------
Gum chewing has been reported to stimulate bowel motility after open surgery, such as cesarean section and other abdominal surgeries. In general, after laparoscopic surgery problems with reduced bowel motility are not as common as after open surgery. In this study the investigators test the hypothesis that gum chewing is enhancing rapid return of bowel motility after gynecologic laparoscopic surgery. Further the investigators study patient satisfaction and potential side effects of postoperative gum chewing.

Official Title
-----------------
Does Gum Chewing After Gynecologic Laparoscopy Stimulate Earlier Return of Bowel Motility?

Conditions
-----------------
Postoperative Care

Intervention / Treatment
-----------------
* Behavioral: gum chewing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all gynecologic laparoscopic surgery normal level of CA 125 postmenopausal Exclusion Criteria: loose teeth chronic obstipation laparotomy operations longer then 3 h

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: chewing gum<br> | Behavioral: gum chewing<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to return to active bowel movements | First active bowel movement is defined as time from operation until first passage of flatus. Time until first defecation will also be measured. | participants will be followed for the duration of hospital stay | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient satisfaction with postoperative gum chewing | Satisfaction will be measured with a visual analog scale (1 participant would never chew gum postoperatively again - 10 participant would always like to chew gum postoperatively) | participants will be followed for the duration of the hospital stay | 
| Number of participants with adverse events | All problems that are linked to postoperative gum chewing will be recorded (e.g. vomiting, aspiration,...) | participants will be followed for the duration of hospital stay |
The Utility of PSADv (PSA Density Velocity) While on Dutasteride for Predicting Prostate Cancer Incidence and Grade and Stage

Study Overview
=================
Brief Summary
-----------------
This is a review of previously published data from a large prostate cancer prevention study known as REDUCE. It is the investigators intention to review whether prostate specific antigen (PSA) velocity (change over time) will predict the presence of prostate cancer and its grade and stage (severity).

Detailed Description
-----------------
This is a review of previously published data from a large prostate cancer prevention study known as REDUCE that utilized a 5 ARI, dutasteride. It is the investigators intention to review whether PSA velocity (change over time) will predict the presence of prostate cancer and its grade and stage (severity) by two year biopsy. The investigator will review and compare data to a previously published study of similar design with finasteride.

Official Title
-----------------
Retrospective Review of Reduce Data to Determine the Utility of PSADv While on Dutasteride for Predicting Prostate Cancer Incidence and Grade and Stage

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men, 50-74 years old with elevated PSA (>=4) along with negative entry biopsy of the prostate who had a subsequent biopsy by 24 months. Exclusion Criteria: Any positive biopsy of the prostate indicative of cancer upon entry

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 74 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PSA Density, Prostate Cancer, Prostate Biopsy, PSA
Observational Study About the Use of Fibrinogen in Adult Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Multicenter prospective observational study, involving all adult patients who underwent cardiac surgery with extracorporeal circulation

Official Title
-----------------
FibCard Study: Observational Study About the Use of Fibrinogen in Adult Cardiac Surgery

Conditions
-----------------
Cardiac Surgery, Extracorporeal Circulation, Fibrinogen

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient over the age of 18 that underwent a cardiac surgery with extracorporeal circulation. Patient who agreed to participate in the study. Exclusion Criteria: Patient under the age of 18.

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The international recommendations published by ESA in 2016 | Review the concordance between the presence / absence of indication (according to the international recommendations published by ESA in 2016) and the prescription / non-prescription of fibrinogen concentrates | 13 Months |