linjc16/ctgov huggingface dataset:
An Open, Randomized Pilot Study to Evaluate the Use of Basiliximab With an Optimized Cyclosporine Dosing on Renal Function in de Novo Liver Transplantation.

Study Overview
=================
Brief Summary
-----------------
The objectives of the study are:To compare the renal function of a quadruple immunosuppressive regimen (including basiliximab in combination with an optimized cyclosporine dose during the first weeks post-transplantation, mycophenolate mofetil and corticosteroids) versus a standard triple therapy regimen (including cyclosporine standard dose, mycophenolate mofetil and corticosteroids)

Official Title
-----------------
An Open, Randomized Pilot Study to Evaluate the Use of Basiliximab With an Optimized Cyclosporine Dosing on Renal Function in de Novo Liver Transplantation.

Conditions
-----------------
Liver Transplantation

Intervention / Treatment
-----------------
* Drug: Basiliximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria First cadaveric liver transplant ABO identical or compatible graft Exclusion Criteria Multiple organ transplant renal impairment defined as glomerular filtration rate (GFR) < 30 ml/min Fulminant liver failure Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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: Basiliximab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function (i.e. glomerular filtration rate) at 12 months post-transplantation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and severity of rejection episodes before 6 and 12 months post-transplantation |  |  | 
| Frequency of death, graft loss or retransplantation before 6 and 12 months post-transplantation |  |  | 
| Adverse events |  |  | 
| Duration of initial hospitalization and number or hospital re-admissions. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Basiliximab, transplantation, liver, renal function
Posterior Narrow Diameter Implants in Hyperglycemic and Normo-glycemic Patients

Study Overview
=================
Brief Summary
-----------------
The aim of the present study was to compare the initial healing and long term performance of narrow diameter implants in patients with uncontrolled Diabetes mellitus type 2 (T2DM) and healthy individuals.

Official Title
-----------------
Evaluation of Posterior Narrow Diameter Implants in Hyperglycemic and Normo-glycemic Patients

Conditions
-----------------
Diabetes Mellitus, Type 2, Implant Complication

Intervention / Treatment
-----------------
* Procedure: Implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients with one or more missing teeth posterior to the canine either in the maxilla or mandible and associated with diminished alveolar ridge dimensions were included in the study Exclusion Criteria: immobility of diabetic patients periodontal surgery and/or antibiotic therapy within the last 6 months prior to baseline pregnancy and lactation period Full Mouth Plaque Score (FMPS) > 25% untreated periodontitis smoking > 10 cigarettes/day insufficient crestal volume making an augmentation procedure necessary previously performed ridge augmentation procedure for a staged implant placement permanent medication potentially affecting blood perfusion rate and bone metabolism

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Control<br>Patients with HbA1c around 6,0 | Procedure: Implantation<br>* Patients received narrow diameter implants in posterior mandible or maxilla<br>|
| T2DM<br>Patients with HbA1c above 6,5 | Procedure: Implantation<br>* Patients received narrow diameter implants in posterior mandible or maxilla<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No difference |  | 3 months |
Comparability DE vs CD-CHO1

Study Overview
=================
Brief Summary
-----------------
Study to Compare the Pharmacokinetics of CD-CHO1 Process BMS-188667 to DE Process BMS-188667 in Healthy Subjects

Official Title
-----------------
Study to Compare the Pharmacokinetics of CD-CHO1 Process BMS-188667 to DE Process BMS188667 in Healthy Subjects

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: Abatacept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed consent form Healthy subjects as determined by good health as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs and clinical laboratory determinations. Body weight for all subjects will be <- 100 kg. body Mass Index (BMI) of 18-30 kg/m2 inclusive; BMI = weight (kg)/[height (m)]2 Men and women (not nursing, not prgnant), who are at least 18 years of age. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study for at least 4 weeks before and for up to 10 weeks after the infusion of BMS-188667 in such a manner that the risk of pregnancy is minimized. Exclusion Criteria: WOCBP and males who are unwilling or unable to use an acceptable method to avoid pregnancy for up to 10 weeks after he infusion of BMS-1886678. WOCBP must also be using an acceptable method of contraception for at least 1 month before dosing. Women who are pregnant ore breast-feeding. Women with positive pregnanacy tes on enrollment or prior to study drug administration. History or current evidence of any signiicant acute or chroinic medical illness

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Abatacept|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To test pharmacokinetics |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To test Safety and immunogenicity |  |  |
Effect of Cemented Implantation in Shoulder Replacement on Blood Pressure

Study Overview
=================
Brief Summary
-----------------
To clarify the downward trend of blood pressure affected by bone cement implantation during shoulder replacement operations.

Detailed Description
-----------------
A total of 350 cases of proximal humeral fracture are planned to be recruited and receive semi-shoulder replacement in Department of Orthopedics and Trauma，Peking University People's Hospital．The blood pressure data are collected from patients' anesthesia records. Both the systolic and diastolic blood pressure are recorded at four time spots during operation: the time before using of bone cement (time period A), 0-5 min after using cement (time period B), 5-10 min after using cement (time period C) and 10-15min after using cement (time period D). The data of blood pressure are collected according to anesthesia records．

Official Title
-----------------
A Multi-center Study on Effect of Cemented Implantation in Shoulder Replacement on Blood Pressure

Conditions
-----------------
Blood Pressure

Intervention / Treatment
-----------------
* Procedure: cemented shoulder replacement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: •patients with three or four part of proximal humeral fracture receiving cemented shoulder replacement Exclusion Criteria: pathologic fracture severe hypertension or hypotension

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cemented shoulder replacement patients<br>A total of 350 cases of proximal humeral fracture receiving cemented shoulder replacement in Department of Orthopedics and Trauma | Procedure: cemented shoulder replacement<br>* proximal humeral fracture receiving hemi-shoulder replacement with cement when inserting the stem<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Systolic Blood Pressure | the systolic blood pressure after insert the cemented stem | Change from Baseline Systolic Blood Pressure at 15 mins | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Diastolic Blood Pressure | the diastolic blood pressure after insert the cemented stem | Change from Baseline Diastolic Blood Pressure at 15 mins | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood Pressure, shoulder replacement, proximal humeral fracture
Phase I Orally Administered 14C-AZD2171 in Patients With Solid Metastatic Tumors

Study Overview
=================
Brief Summary
-----------------
Open, non-randomised, radiolabelled, single centre study with a total of six patients with solid metastatic tumors to determine the rates and routes of elimination of 14C-AZD2171 and its metabolites.

Official Title
-----------------
A Phase 1, Open Label, Non-Randomised, Single Centre Pharmacokinetic and Mass Balance Study of Orally Administered 14-C-AZD2171 in Patients With Solid Metastatic Tumours

Conditions
-----------------
Advanced Solid Metastatic Tumor

Intervention / Treatment
-----------------
* Drug: AZD2171


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically confirmed metastatic tumor which is refractory to standard therapies life expectancy is 12 weeks or longer WHO performance status is 0-12 Exclusion Criteria: radiotherapy and chemotherapy within 4 weeks before the start of the study treatment patients with a history of poorly controlled hypertension history or evidence of any medical condition that might affect gastrointestinal function patients that have participated in a radiolabelled study in the last 5 years

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AZD2171|oral 14C|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective is to determine the rates & routes of excretion of 14C radiolabelled AZD2171 in patients by assessment of concentrations of total 14C radioactivity and AZD2171 in plasma & concentrations of total radioactivity in urine&faeces |  | assessed at time intervals post dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
phase I, AZD2171, solid tumor, metastatic tumor
Observational Study to Evaluate the Safety of NovoMix® 30 FlexPen®

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Africa. The aim of this observational study is to evaluate the incidence of adverse events while using NovoMix® 30 FlexPen® under normal clinical practice conditions.

Official Title
-----------------
An Observational Study Evaluating the Safety and Efficacy of the Treatment With Biphasic Insulin Aspart (NovoMix® 30 FlexPen®) in the Treatment of Type 2 Diabetics After Failing on Basal/ Intermediate Mono or Combination Therapy

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

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart 30


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes having failed on basal insulin with or without OAD HbA1c greater than 7.0% Exclusion Criteria: Subjects being unlikely to comply with protocol requirements Subjects who previously enrolled in this study Subjects with hypersensitivity to biphasic insulin aspart or any of the excipients Women who are pregnant, breast feeding and women in child bearing capacity who are not using reliable contraceptive method
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: biphasic insulin aspart 30<br>* Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation<br>* Other names: NovoMix® 30;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of major hypoglycaemic events reported as serious adverse drug reactions |  | during 26 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of serious adverse drug reactions |  | during 26 weeks of treatment | 
| Number of serious adverse events |  | during 26 weeks of treatment | 
| Number of all major (daytime and nocturnal) hypoglycaemic events |  | during 26 weeks of treatment | 
| Number of all minor (daytime and nocturnal) hypoglycaemic events |  | during 26 weeks of treatment | 
| Weight (BMI) change from baseline |  | At the end of the study | 
| HbA1c change from baseline |  | At the end of the study | 
| Percentage of patients reaching the target of HbA1c of less than or equal to 7.0% |  | At the end of the study | 
| Average (mean) fasting plasma glucose level |  | At the end of the study | 
| Average post-breakfast (90-120 mins), post-lunch (90-120 mins), post-dinner (90-120 mins) plasma glucose level |  | At the end of the study |
Impact of Weight Loss Induced by Bariatric Surgery or Nutritional Management on Sexual Function in Men With Severe Obesity

Study Overview
=================
Brief Summary
-----------------
Study of the impact of weight loss induced by surgery (interventional group) or optimal nutritional management (control group) on sexual function in men with severe obesity

Official Title
-----------------
Comparing the Impact of Weight Loss Induced by Bariatric Surgery or Through a Standard Nutritional Management on Sexual Function and Sperm Quality in Men With Severe Obesity - Multicenter, Prospective

Conditions
-----------------
Obesity, Bariatric Surgery Candidate

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe obesity with BMI> 25 kg / m2 Exclusion Criteria: Patient having undergone sterilization

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bariatric surgery<br> | |
| standard nutritional management<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of sexual function assessed by International Index for Erectile Dysfunction (IIED) | This questionnaire consists of 15 questions addressing the following topics: erectile function, orgasmic function, sexual desire, satisfaction of the sexual relation, satisfaction of the relationship in general. Each question is scored from 0 to 5. All responses are scored between 0 and 75. Sexual function is considered normal if the IIED score is greater than 25 | at 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with normal sexual function (IIED> 25) with and without surgery. |  | ay 1 year | 
| Change the spermatic parameters before and after weight loss in both groups |  | at 1 year and 2 years | 
| Change the serum profile of sex hormones before and after weight loss in both groups a |  | at 1 year | 
| Correlate the spermatic profile to the different nutritional deficiencies high lighted after the bariatric surgery |  | at 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fertility, bariatric surgery
Flupenthixol Decanoate in Methamphetamine Smoking - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of flupenthixol decanoate for treatment of methamphetamine dependence. Also, study will compare flupenthixol with desipramine in blocking methamphetamine self-administration.

Official Title
-----------------
Flupenthixol Decanoate in Methamphetamine Smoking

Conditions
-----------------
Substance-Related Disorders

Intervention / Treatment
-----------------
* Drug: Flupenthixol


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Flupenthixol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Methamphetamine use |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
methamphetamine dependence
Balanced Salt Solution VS. Normal Saline Solution in Septic Shock

Study Overview
=================
Brief Summary
-----------------
The Purpose of this study is to determine the impact of balanced salt solution versus chloride rich solution on clinical outcomes in paediatric severe sepsis or septic shock

Detailed Description
-----------------
The surviving sepsis campaign guideline recommended the isotonic crystalloids as the first choice of initial fluid resuscitation. The isotonic crystalloids are including chloride-rich solution (eg.NSS) and balanced salt solution. Retrospective study showed normal saline can induced hyperchloremic metabolic acidosis and acute kidney injury. However, no randomized controlled trial compare efficacy between the balanced salt solution and chloride rich solution.

Official Title
-----------------
Balanced Salt Solution Versus Normal Saline Solution During Initial Resuscitation in Severe Sepsis or Septic Shock Children: A Randomized Controlled Trial

Conditions
-----------------
Shock, Septic, Sepsis

Intervention / Treatment
-----------------
* Drug: Ringer acetate
* Drug: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children younger than 18 year old who has severe sepsis or septic shock inform consent Exclusion Criteria: children who had shock from other aetiologies end stage disease or severe congenital anomaly refuse to inform consent

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum 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: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ringer Acetate<br>Ringer acetate 10-20 ml/kg IV bolus when patient need fluid bolus | Drug: Ringer acetate<br>* Ringer acetate 10-20 ml/kg IV bolus in 15-30 min,repeat bolus as needed by patient status<br>|
| Active Comparator: Normal saline<br>NSS 10-20 ml/kg IV bolus when patient need fluid bolus | Drug: Normal saline<br>* NSS 10-20 ml/kg IV bolus in 15-30 min,repeat bolus as needed by patient status<br>* Other names: NSS;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of hyperchloremic metabolic acidosis |  | 48 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28 day and 90 day mortality rate |  | 28 days and 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Severe sepsis, Balanced Salt Solution, Normal Saline