linjc16/ctgov huggingface dataset:
Noninvasive Methods to Monitor Graft Survival in Kidney Transplant Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test noninvasive methods to monitor the health and condition of new kidneys in people who have received kidney transplants.

Detailed Description
-----------------
Innovations in kidney transplantation have improved short-term outcomes for transplant patients. However, organ rejection remains as an important threat to the long-term survival of the transplanted organ. If clinicians could better monitor the condition of the organ after transplantation, they may be able to improve the chance of graft survival. Noninvasive ways to monitor the condition of the transplanted organ need to be developed and tested. This observational study will investigate whether certain blood and urine tests are useful in monitoring the health of transplanted kidneys. This trial will involve 14 post-transplant study visits over the course of 2 years. A physical exam, medication history, adverse events assessment, and blood and urine collection will occur at all visits. Kidney biopsies will occur at study entry prior to transplantation and at Month 6, in adult participants only. Protocol biopsies are optional in the pediatric substudy group. Additional visits may be required if organ rejection is suspected.

Official Title
-----------------
Noninvasive Monitoring to Predict Outcome in De Novo Kidney Transplant Recipients

Conditions
-----------------
Kidney Transplantation

Intervention / Treatment
-----------------
* Procedure: Kidney transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Candidate for deceased donor or living donor kidney transplant Negative Crossmatch Parent or guardian willing to provide informed consent, if applicable Exclusion Criteria: Clinically significant liver disease Other illnesses that, in the opinion of the investigator, may interfere with the study Recipient of multiple organ transplants Inability or unwillingness to comply with the study protocol
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Kidney transplantation|Participants in this study will have had a kidney transplant|

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
-----------------
Kidney, Transplant, Rejection, Kidney Disease, Kidney Failure, End Stage Renal Disease
A Prospective, Multi-center Study to Evaluate the Efficacy and Safety of Vitamin D3 B.O.N. Intramuscular Injection in Adults With Vitamin D Deficiency

Study Overview
=================
Brief Summary
-----------------
To compare the efficacy of Vitamin D3 B.O.N. Intramuscular Injection within 12 weeks with that of placebo in adults with Vitamin D Deficiency.

Official Title
-----------------
A Prospective, Multi-centre, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Vitamin D3 B.O.N. Intramuscular Injection in Adults With Vitamin D Deficiency

Conditions
-----------------
Vitamin D Deficiency

Intervention / Treatment
-----------------
* Drug: Vitamin D3 B.O.N. Injection (cholecalciferol 200,000IU)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with vitamin D deficiency Exclusion Criteria: Subjects who experienced a hypersensitivity to the cholecalciferol Subjects with renal impairment Subjects with Hypercalcemia Subjects with Hypercalciuria Subjects with clinically doubted calcium stone Subjects diagnosed with sarcoidosis Subjected diagnosed with pseudo-hypoparathyroidism Subjected with malignancy Subjects with clinically significant cardiovascular or lung impairment Judged by the investigator Subjects with the below laboratory abnormality (Platelet, WBC, Absolute neutrophil count, Albumin, AST or ALT) Subjects who are to take vitamin D supplements during the study period

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Experimental: Vitamin D deficiency<br>Group 1 | Drug: Vitamin D3 B.O.N. Injection (cholecalciferol 200,000IU)<br> <br> Drug: Placebo<br> <br> |
| Experimental: Vitamin D deficiency (Low)<br>Group 2 | Drug: Vitamin D3 B.O.N. Injection (cholecalciferol 200,000IU)<br> <br> Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Efficacy Endpoints (serum 25(OH)D concentration) | serum 25(OH)D concentration | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Efficacy Endpoints (serum 25(OH)D concentration) | serum 25(OH)D concentration | 24 weeks |
Topical Antiperspirant for Hand-Foot Syndrome

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to evaluate the effectiveness of an antiperspirant in preventing or attenuating the severity of palmer-plantar erythrodysesthesia associated with the Food and Drug Administration (FDA)-approved doses of capecitabine. The hypothesis is that cytotoxic compounds in sweat will be prevented from being deposited in the skin and causing chronic toxicity.

Official Title
-----------------
Topical Antiperspirant for Prevention of Palmar-Plantar Erythrodysesthesia (Hand-Foot Syndrome) Associated With Capecitabine

Conditions
-----------------
Palmar-plantar Erythrodysesthesia

Intervention / Treatment
-----------------
* Drug: antiperspirant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has not previously received a regimen that includes 5-fluorouracil > 18 years old No known allergy or intolerance to Ban Unscented Roll-On Antiperspirant Exclusion Criteria: < 18 years of age

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: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>antiperspirant topically to one foot once daily | Drug: antiperspirant<br>* antiperspirant topically once daily to one foot<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction in palm and/or sole pain |  | after each of first four cycles of chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of utility of digital photography in the following palmar-plantar erythrodysesthesia (PPES) |  | after each of first four cycles of chemotherapy |
Safety and Efficacy of Insulin Aspart vs. Regular Human Insulin in Gestational Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in the United States of America (USA). The purpose of this study is to test whether NovoLog (insulin aspart) is a safe and at least as effective alternative to regular human insulin for the control of blood glucose after meals in women who develop diabetes during pregnancy.

Official Title
-----------------
Safety and Efficacy of Insulin Aspart vs. Regular Human Insulin in Basal/Bolus Therapy for Patients With Gestational Diabetes

Conditions
-----------------
Diabetes, Gestational Diabetes

Intervention / Treatment
-----------------
* Drug: human insulin
* Drug: insulin NPH
* Drug: insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects older than 35 years old will be considered Gestational diabetes mellitus

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

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

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

| Intervention/Treatment |
| --- |
|Drug: human insulin|nan|
|Drug: insulin NPH|nan|
|Drug: insulin aspart|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial glycemic control |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c (glycosylated haemoglobin A1c) |  |  | 
| Postprandial endogenous insulin secretory response |  |  | 
| Hypoglycemic episodes |  |  | 
| Adverse events |  |  |
Macular Hole Reopening

Study Overview
=================
Brief Summary
-----------------
The purpose of this investigation was to determine the incidence and the factors that cause a reopening of a macular hole (MH) after a surgical closure.

Detailed Description
-----------------
A reopening of a macular hole (MH) is a well-known complication of successfully closed MHs. Recently, internal limiting membrane (ILM) peeling has become widely used as an adjunctive procedure during MH surgery. The incidence of a reopening of a MH is 0 to 8.6% in eyes in which the ILM was peeled off, and 2 to 16% in which the ILM was not peeled off. Part of the variation in the percentages of reopening was the length of the follow-up period; eyes with longer follow-up periods have higher incidences of reopening.

Official Title
-----------------
Incidence and Factors Related to Macular Hole Reopening

Conditions
-----------------
Vitrectomy

Intervention / Treatment
-----------------
* Procedure: Vitrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who underwent vitrectomy with or without internal limiting membrane (ILM) peeling for an idiopathic full-thickness macular hole Exclusion Criteria: eyes with previous vitreous surgery, cystoid macular edema from any cause, and traumatically-induced MH were excluded.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vitrectomy<br>Patients underwent vitrectomy with or without internal limiting membrane (ILM) peeling for an idiopathic full-thickness macular hole. Simultaneous phacoemulsification with intraocular lens implantation was performed on all phakic patients who were >40-years-of-age. | Procedure: Vitrectomy<br>* Patients underwent vitrectomy with or without internal limiting membrane (ILM) peeling for an idiopathic full-thickness macular holes. Simultaneous phacoemulsification with intraocular lens implantation was performed on all phakic patients who were >40-years-of-age.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A complete clinical examination including BCVA, slit-lamp biomicroscopy with a contact lens, indirect ophthalmoscopy, and fundus photography were performed post surgery. |  | Patients were examined preoperatively and postoperatively on day one, and at two weeks, and one, three, and six months. Thereafter, they were examined every three to six months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitrectomy, macular hole, ILM peeling
Incidence of Tinnitus Amongst Teenagers and Young Adults mp3 Users

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the incidence of tinnitus between mp3 users and non-users, aged between 15 and 30 years old. 100 patients will be recruited in Valença secondary schools. High frequency audiometry and otoacoustic emissions will be performed.Tinnitus patients will complete the Tinnitus Handicap Inventory questionnaire.

Conditions
-----------------
Tinnitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 15 to 30 years old A-n tympanogram Exclusion Criteria: muscular tinnitus vascular tinnitus somatosensorial tinnitus concomitant TMJ disorders external and middle ear diseases professional or recreative exposure to other noise sources other than mp3 players

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 30 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 |
| --- | --- |
| Group 1 - mp3 users<br>Subjects who have been using mp3 players for at least 1 hour per day for at least 1 year | |
| Group 2 - mp3 non-users<br>Subjects who does not listen regularly to mp3 music | |

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
-----------------
tinnitus, mp3 players, noise induced hearing loss, high frequencies audiometry, acoustic otoemissions
Bladder Thermal Distention for Patients With Interstitial Cystitis / Painful Bladder Syndrome

Study Overview
=================
Brief Summary
-----------------
Patients with Interstitial Cystitis / PBS will be treated with bladder thermal distention (BTD).

Detailed Description
-----------------
In this study we will evaluate the efficacy of bladder thermal distention (BTD) in patients with IC/PBS. Patients with previous failed conventional treatment (intravesical DMSO) will be recruited.

Official Title
-----------------
Bladder Thermal Distention for Patients With Interstitial Cystitis / Painful Bladder Syndrome

Conditions
-----------------
Interstitial Cystitis, Painful Bladder Syndrome

Intervention / Treatment
-----------------
* Procedure: Bladder Thermal Distention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -All patients with interstitial cystitis / painful bladder syndrome (IC/PBS) who had previous intravesical treatment with DMSO Exclusion Criteria: Active infection Urethral stricture

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bladder Thermal Distention (BTD)<br>Continuous irrigation of the bladder with warm saline (up to 45 Celsius) using the PelvixTT system | Procedure: Bladder Thermal Distention<br>* Bladder Thermal Distention (BTD) is an approved procedure in Europe and Israel. Continuous irrigation of the bladder with warm saline with the PelvixTT system. The procedure will be performed on an outpatients basis. The procedure lasts 1 hour.<br>* Other names: PelvixTT - Hyperthermia Elmedical LTD, Israel;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| o'leary sant questionnaire | o'leary sant questionnaire is a validated specific tool for evaluation of IC/PBS symptoms | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bladder diary | symptoms like urgency. frequency and functional voided volumes will be monitored | up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bladder hydrodistention, Interstitial cystitis, painful bladder syndrome, hyperthermia
The Incidence of Perioperative Deep Venous Thromboses of the Lower Extremities

Study Overview
=================
Brief Summary
-----------------
The study's hypothesis is that there are some patients who come for surgery who have asymptomatic clots in their lower extremities upon their arrival to the hospital for their surgical admission. We will be performing duplex studies of the subjects' legs before their surgery to determine how often clots are present. We will also perform duplex scans of the legs after the subjects' surgeries to determine what factors (surgical, anesthetic, co-morbidities)are correlated with the development of DVTs.

Official Title
-----------------
The Incidence of Perioperative Deep Venous Thromboses of the Lower Extremities

Conditions
-----------------
Perioperative DVTs

Intervention / Treatment
-----------------
* Procedure: Duplex scan of lower extremities


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18+ and consentable Exclusion Criteria: Anticoagulation therapy or known DVT

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Duplex scan<br>Subjects undergo preoperative and post-operative duplex scanning of the lower extremities | Procedure: Duplex scan of lower extremities<br>* Lower extremities will be duplex scanned pre and post-operatively<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of preoperative DVTs |  | Day of surgery | 
| Incidence of post-operative DVTs |  | Within 48 hours of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors associated with the development of perioperative DVTs |  | Within 180 days of surgery | 
| Distribution and laterality | Level and laterality of clots that develop and association of these with risk factors | Within 180 days of surgery | 
| Risks associated with perioperative DVTs | Association of clinical pulmonary emboli and/or cardiac arrests, cerebral vascular events, or other causes of death or significant morbidities (e.g., post-op pneumonias or other infections)perioperatively with DVTs | Within 180 days of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surgery, Deep Vein Thrombosis, Preoperative
Patterns of Care in Hormone-receptor Positive, Advanced Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to characterize the current patterns of care for patients with hormone-receptor-positive, advanced breast cancer who have failed one prior endocrine therapy in Brazil. To investigate patient-related, disease-related and physician-related characteristics that correlate with the use of either endocrine treatment or chemotherapy in such patients. And to evaluate patients' understanding of the treatment options and their participation in the choice.

Official Title
-----------------
Patterns of Care in Hormone-Receptor Positive, Advanced Breast Cancer in Brazil: A Prospective, Observational Study

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological or cytological diagnosis of breast cancer Postmenopausal status at the time of enrolment, according to the following definitions: History of bilateral oophorectomy at any age Proven hormonal menopause Positive estrogen receptor (ER) and/or progesterone receptor (PR) by immuno Failure of one previous endocrine therapy in the adjuvant or metastatic setting Use of no more than one previous chemotherapy regimen in the neoadjuvant or adjuvant setting Indication to receive chemotherapy or endocrine therapy Exclusion Criteria: Inability to comply with the study protocol Use of more than one previous endocrine therapy, regardless of the setting; -- Previous use of chemotherapy for metastatic disease Use of neoadjuvant endocrine therapy as the only previous type of endocrine therapy Serious medical, surgical or psychiatric comorbidity that, upon investigator's discretion, should preclude participation in the study.

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

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

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 |
| --- | --- | --- |
| To assess the treatment choice by the medical oncologist for each patient. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess determinants of treatment choice |  | 12 months | 
| To assess the duration of treatment with chemotherapy or endocrine therapy |  | 12 months | 
| To evaluate the rate of treatment continuation at 6 months | Assess the profile of adverse events with each treatment modality and assess patient participation and understanding in treatment choice | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer, Hormone Receptor Positive, Advanced Breast Cancer