linjc16/ctgov huggingface dataset:
The Effect Of Simvastatin On Bone Remodeling In Socket Of Mandibular Teeth

Study Overview
=================
Brief Summary
-----------------
Simvastatin has been reported to promote osteoblastic activity and inhibit osteoclastic activity by enhancing the expression of BMP2. There have been many studies demonstrating the bone-promoting effect of local application various animal models including after application into socket of teeth in a rat. the purpose of the study is to investigate the effect of slow release topical simvastatin in socket of mandibular teeth on bone remodeling in the socket

Detailed Description
-----------------
after extraction of mandibular single root teeth 10 mg of slow release simvastatin would be inserted to the socket. observation will be at 1 week, 4 weeks and 3 months.after 3 months the patients will have dental CT as done routinely in our clinic before placing dental implants and the bone density and height will be measured on this data. during the procedure of inserting a dental implant a trephine will be taken for histology.

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: Simvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: need extraction of single root tooth intend to have prosthetic implant in place of extraction Exclusion Criteria: treated with simvastatin P.O for hypercholesterolemia

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>simvastatin will be inserted to sockets | Drug: Simvastatin<br>* 10 mg simvastatin, slow release in socket of extracted tooth (single application only)<br>|
| No Intervention: control<br>sockets will be left to healing without material in socket | Drug: Simvastatin<br>* 10 mg simvastatin, slow release in socket of extracted tooth (single application only)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone height and density in former socket | measured on CT | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone mineralization | histology from bone in former socket | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
remodeling, simvastatin, alveolar bone, tooth extraction, alveolar bone remodeling
Weekly TP-HDFL in the Treatment of Advanced TCC

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of Weekly TP-HDFL in advanced transitional cell carcinoma in terms of response rate and overall survival.

Detailed Description
-----------------
Transitional cell carcinoma(TCC)of urothelium,including bladder, ureter, and renal pelvis TCCs, was the most lethal urology malignancy in Taiwan. In 1995, approximately 1,300 new cases of TCC was diagnosed in Taiwan and more than 600 patients died of this disease. Advanced TCC is a moderately chemosensitive disease. A combination of methotrexate, vinblastine, and cisplatin with or without doxorubicin (M-VAC or CMV) has been widely used since 1980s. Despite the response rate was as high as 40-70%, the survival of these patients was only slightly increased from a median of 7 to 9 months for those who were treated with supportive care or cisplatin alone to a median of 12 months by cisplatin-based combination chemotherapy. One of the reasons for the poor treatment results is the inevitable treatment-related toxicities related to conventional systemic chemotherapy.

Official Title
-----------------
A Phase II Study of Weekly Paclitaxel, Cisplatin and 24-Hour Infusion of High-Dose 5-Fluorouracil and Leucovorin(Weekly TP-HDFL) in the Treatment of Advanced Transitional Cell Carcinoma(TCC)

Conditions
-----------------
Transitional Cell Carcinoma

Intervention / Treatment
-----------------
* Drug: Paclitaxel, Cisplatin, 5-Fluorouracil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathology proven TCC Recurrent or metastatic TCC Muscle-invasive TCC Measurable disease Age>18 KPS>60﹪ Creatinine clearance>35ml/min, AST/ALT < or = 3.5times upper limits of normal reference values Bilirubin< or = 2.0 mg/dl WBC > or = 4,000/mm3, PLT > or = 100,000/mm3 Written informed consent Exclusion Criteria: Previous systemic chemo is not allowed TG <70mg/dl CNS metastasis Life expectancy less than 3 months

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Paclitaxel, Cisplatin, 5-Fluorouracil<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate |  | 2000 2005 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival ,Safety |  | 2000 2005 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Combination, Chemotherapy,transitional cell carcinoma
Prevalence of Osteosarcopenic Obesity in Older Adults

Study Overview
=================
Brief Summary
-----------------
Osteosarcopenic Obesity (OSO) is a syndrome characterized by the loss of bone and muscle in addition to increase in the fat tissue as a result of aging process. It is the latest point of impairment in the bone,muscle and adipose tissue in older adults. OSO, as the name suggests, is the combination of three syndrome frequently encountered in the elderly: osteopenia/osteoporosis, sarcopenia and obesity. The aims of study are to determine the prevalence of OSO syndrome in community-dwelling adults of Turkey and determine the possible factors regarding risk of falling in this population

Official Title
-----------------
Prevalence of Osteosarcopenic Obesity in Older Community-dwelling Adults in Turkey

Conditions
-----------------
Obesity, Sarcopenia, Osteopenia, Osteoporosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age of 65 or over Being had been examined for all the primary outcome measures (i.e. the results of primary outcomes must be in the patient's file) Exclusion Criteria: Severe cognitive dysfunction not being able to walk independently for 4 m

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- | --- |
| T score | T scores of spine and femur neck examined with Dual X-Ray Absorptiometry. A T score<-2,5 will be classified as osteoporosis while a T score between -1 and -2,5 will be counted as osteopenia | 1 hour | 
| Muscle Strength | Measured by hand held dynamometer. The cut-off scores for man and woman are 27 kg and 16 kg, respectively | 5 minutes | 
| Muscle Mass | Measured by bioimpedance analysis using Tanita TBF300. The cut-off scores for man and woman are 9,2 kg/m2 and 7,4 kg/m2, respectively | 2 minutes | 
| Muscle Performance | Tested by 4 meter walk test. If the gait speed is lower than 0,8 m/s, the test is positive. | 3 minutes | 
| Obesity | The fat percentage and the Body Mass Index measured by bioimpedance analysis using Tanita TBF300 is recorded. For BMI, 30 kg/m2 and over is classified as obesity whereas fat percentage of %35 and %28 (woman and man, respectively) and over was classified as obese. | 2 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comorbidity | Using Charlson Comorbidity Index | 3 minutes | 
| History of falls | A patient's self stated history of falls will be considered as having a history of fall or not. | 1 minutes |
Study Evaluating Sirolimus in Kidney Transplant Recipients in India

Study Overview
=================
Brief Summary
-----------------
To determine the safety of sirolimus tablets in renal allograft recipients in a postmarketing surveillance setting.

Official Title
-----------------
A Post Marketing Surveillance Looking at Safety of Rapamune (Sirolimus) in Indian Population Undergoing de Novo Renal Transplantation.

Conditions
-----------------
Kidney Failure, Graft vs Host Disease

Intervention / Treatment
-----------------
* Drug: Rapamune


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in End Stage Renal Disease who are above 13 years of age and weigh more than 40 kilograms. Patients scheduled to receive a kidney from a cadaveric donor, from a living unrelated donor or from a living related donor. Exclusion Criteria: Evidence of major infections at the time of sirolimus administration Use of any investigational drug or treatment up to 4 weeks prior to enrolling in the study and during the treatment phase. Females who are pregnant, breast feeding or in reproductive age group and not using a medically acceptable form of contraception

Ages Eligible for Study
-----------------
Minimum Age: 13 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: Rapamune|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety evaluation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney, Transplant
Clinical Efficacy of Roxithromycin in Men With Chronic Prostatitis/Chronic Pelvic Pain Syndrome

Study Overview
=================
Brief Summary
-----------------
Roxithromycin is effective in the treatment of intracellular organisms, including chlamydia and mycoplasma, and exhibits anti-inflammatory and immunomodulatory effects on respiratory diseases. To explore the potential therapeutic benefit of roxithromycin in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), this study compared the effect of roxithromycin with ciprofloxacin and aceclofenac.

Detailed Description
-----------------
A total of 75 patients with CP/CPPS were randomized to three groups in open-label: group 1, ciprofloxacin; group 2, aceclofenac; and group 3, roxithromycin. The patients were treated for 4 weeks and were subsequently followed for 12 weeks. Changes from baseline in the total and domain scores of the NIH Chronic Prostatitis Symptom Index (NIH-CPSI) were evaluated.

Conditions
-----------------
Chronic Prostatitis, Chronic Pelvic Pain Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of category IIIa of IIIb chronic prostatitis NIH-CPSI (National Institute of Health Chronic Prostatitis Symptom Index) score ≥ 15 Exclusion Criteria: Urinary tract infection or uropathogen within the past 12 months Serious medical problems NIH consensus exclusion criteria13 (presence of active urethritis, urogenital cancer, urinary tract disease, functionally significant urethral stricture, neurological disease affecting the bladder, etc.) Drug therapy that might affect lower urinary tract functions within the past 3 months
Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
| NIH-CPSI score | Changes from baseline in the total and domain scores of the NIH Chronic Prostatitis Symptom Index (NIH-CPSI) were evaluated. | 12 weeks |
Decrease in Temperature as a Pagtonomic Sign by Scorpion Sting

Study Overview
=================
Brief Summary
-----------------
The scorpion sting is a medical disease, for the signs and symptoms presented; Sometimes patients do not know the animal that causes these symptoms; the bibliography marks the decrease in temperature as a sign to be presented.

Detailed Description
-----------------
The scorpion sting is a medical emergency where 184 patients from the state of Guanajuato were divided into 2 groups according to the type of antivenom administered, the dose of antivenom were at the discretion of the attending physician, Birmex (n = 117) and Alacramyn (n = 67) for the temperature record of the site of sting and other vital signs, this to compare it with the bibliography as a pathognomonic sign.

Official Title
-----------------
Decrease in Temperature by Scorpion Sting: a Pagtonomic Sign

Conditions
-----------------
Scorpion Stings

Intervention / Treatment
-----------------
* Diagnostic Test: Vital signs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scorpion sting All sex 3 - 90 ages Exclusion Criteria: Application of ice at the sting site

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 90 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>Patients who apply anti-scorpion venom serum Birmex at the discretion of the attending physician were given vital signs. | Diagnostic Test: Vital signs<br>* Axillary temperature sampling, at the site of the scorpion sting and the contralateral site with infrared thermometer, and heart rate, respiratory rate and blood pressure on admission, 30 minutes after applying the vial and the medical discharge<br>|
| 2<br>Patients who apply anti-scorpion venom serum Alacramyn at the discretion of the attending physician were given vital signs. | Diagnostic Test: Vital signs<br>* Axillary temperature sampling, at the site of the scorpion sting and the contralateral site with infrared thermometer, and heart rate, respiratory rate and blood pressure on admission, 30 minutes after applying the vial and the medical discharge<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temperature change | Temperature at the sting site, contralateral site and axillary in degrees celcius | 0, 30 and 120 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood preasure | Systolic and diastolic in mmHg | 0, 30 and 120 minutes | 
| Heart rate | Beats per minute | 0, 30 and 120 minutes | 
| Respiratory rate | Breaths per minute | 0, 30 and 120 minutes |
Which Type of Laparoscopic Colectomy, Right or Left, Have Better Postoperative Outcomes for the Patients?

Study Overview
=================
Brief Summary
-----------------
Laparoscopic surgery decreased the morbidity of colorectal surgery. The two most common surgeries for colorectal cancer are right and left colectomy. Objective: To compare perioperative morbidity of the right versus left colectomy for cancer, as well as the quality of laparoscopic oncologic resection of both procedures. Methods: Retrospective analysis of prospectively collected data from patients operated at the University of São Paulo School of Medicine, between 2006 and 2016. Postoperative complications were classified with scale within 30 days after surgery. Grade III or greater was considered serious complication. Quality of oncologic resection was assessed by the average number of lymph nodes harvested and surgical margins.

Detailed Description
-----------------
Laparoscopic surgery decreased the morbidity of colorectal surgery. The two most common surgeries for colorectal cancer are right and left colectomy. This retrospective analysis of prospectively collected data from patients operated at the University of São Paulo School of Medicine, between 2006 and 2016. Postoperative complications were classified by scale within 30 days after surgery. There were 332 patients operated.

Official Title
-----------------
Which Type of Laparoscopic Colectomy, Right or Left, Have Better Postoperative Outcomes for the Patients?

Conditions
-----------------
Colorectal Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who underwent laparoscopic right or left elective colectomy for colon adenocarcinoma. Exclusion Criteria: Patients who underwent total colectomy Resections that included the rectum Exclusive transverse resections Multivisceral resections

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Postoperative complications | Complications | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colectomy, colorectal, laparoscopy
Efficacy of Magnesium and Alpha Lipoic Acid Supplementation in Reducing Premature Uterine Contractions

Study Overview
=================
Brief Summary
-----------------
To evaluate whether a combined supplementation of magnesium and lipoic acid is able to significantly reduce the incidence of uterine contractions and related episodes of hospitalization in pregnant women.

Detailed Description
-----------------
Primary prevention of preterm labor is based on the early identification of risk factors and on appropriate treatments. Although several drugs are currently used, the identification of effective and safe agents able to improve both maternal and fetal health is still warranted. In this study the efficacy a formulation based on magnesium and alpha-lipoic acid has been compared with placebo to evaluate the incidence of reduction of preterm delivery. Three hundred pregnant women at 14-34 weeks of gestation were enrolled and randomly divided to receive a daily single tablet containing magnesium and alpha-lipoic acid supplement or placebo until delivery.

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Dietary Supplement: Magnesium plus alpha-lipoic acid
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 14-34 weeks of gestation Exclusion Criteria: Preexisting diabetes mellitus Systolic blood pressure >140mm Hg Cancer lupus hepatitis HIV/AIDS Diagnosed alcohol or chemical dependency

Ages Eligible for Study
-----------------
Minimum Age: 23 Years
Maximum Age: 41 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Magnesium + Lipoic Acid<br> | Dietary Supplement: Magnesium plus alpha-lipoic acid<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of women with sporadic episodes of preterm uterine contraction |  | From baseline (beginning of the treatment) until delivery | 
| Number of women with frequent and persistent episodes of preterm uterine contractions associated with pain |  | From baseline (beginning of the treatment) until delivery | 
| Number of women needed for hospital admission for threatened preterm labour |  | From baseline (beginning of the treatment) until delivery |
Multi-center Register for the Use of the Cor-Knot® Automated Knotting System in Heart Valve Surgery

Study Overview
=================
Brief Summary
-----------------
The Cor-Knot® device is an automated knotting system for valve sutures and prosthetic rings used for more than a year during valve replacements and annuloplasties in cardiac surgery. It reduces the time spent knotting the threads fixing the prosthesis and thus reduces aortic clamping and extracorporeal circulation times. The originality of the project is based on the absence of national multi-rate data collection on the effectiveness and safety of the Cor-Knot® knotting device.

Official Title
-----------------
Multi-center Register for the Use of the Cor-Knot® Automated Knotting System in Heart Valve Surgery

Conditions
-----------------
Vascular Surgery

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: programmed minimally invasive surgery for: aortic valve replacement mitral valve replacement mitral valve plastic surgery adult patient Exclusion Criteria: emergency surgery

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

| Intervention/Treatment |
| --- |
|Other: Data collection|Data on the effectiveness and safety of the Cor-Knot® knotting device|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of periprosthetic leak around the prosthetic rings as determined during physical examination (rated yes/no ) |  | Day 30 |