linjc16/ctgov huggingface dataset:
Evaluation of Immediate Preoperative Instillation (IPOI) of Mitomycin C Compared to Early Postoperative Instillation (IPOP) in Non-muscle Invasive Bladder Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of this pilot study is to assess the efficacy and toxicity of immediate pre-operative instillation of mitomycin C compared to the standard early post-operative .

Conditions
-----------------
Non Muscle-invasive Bladder Cancer

Intervention / Treatment
-----------------
* Procedure: IPOI (pre-operative)
* Procedure: IPOP (post-operative)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years, Primary or recurrent bladder tumor with endoscopic papillary aspect, One or two bladder tumors, Cytology before TURB showing no high-grade cells, Patients without tutorship or subordination (ou curatorship), Patients under the general social security system or qualifying through a third party, Informed consent signed by the patient after clear and fair information. Exclusion Criteria: Age < 18 years, Allergy to mitomycin C, Traumatic stenting, Upper tract urothelial cancer, Urethral invasion, History of muscle invasive bladder cancer, Extensive tumor (3 cm or more), Any contraindication to TURB, Simultaneous participation in another clinical research study, Patients not insured by the social security or not qualifying through a third party, Patients with enhanced protection, namely pregnant or lactating women, persons deprived of their liberty by a judicial or administrative decision, people staying in a health or social institution, adults under legal protection, and finally patients in emergency situations, Pregnant or lactating females or women of childbearing potential not willing to use an adequate method of birth control for the duration of the study (i.e. hormonal / mechanical contraceptive : oral, injectable, transdermal, implantable, intrauterine or surgical device: tubal ligation, hysterectomy, total oophorectomy).

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IPOI<br>One arm with pre-operative instillation of mitomycine 1h before TURB (IPOI : Instillation pré-opératoire immédiate), | Procedure: IPOI (pre-operative)<br> <br> |
| Active Comparator: IPOP<br>One arm with early post-operative instillation of mitomycine within 24 hours (IPOP : Instillation Post Opératoire Précoce). | Procedure: IPOP (post-operative)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
low-grade, NMIBC
Infants of Diabetic Mothers: A Cohort Study

Study Overview
=================
Brief Summary
-----------------
Saudi Arabia has been named by the International Diabetes Federation as among the top ten countries with highest prevalence of diabetes. Women are said to have overall prevalence twice that for men. With high birth rate in the country we decided to look at the impact of diabetic pregnancies on their off-springs

Detailed Description
-----------------
Diabetics are followed regularly in diabetic outpatient clinics where dietary and medical management are offered. Diabetic pregnancies are managed by a team consisting of diabetologist, obstetrician, feto-maternal obstetrician and dietician. Management of these pregnancies depends on whether these women have pre-gestational or gestational diabetes. Very few diabetic women have exposure to preconceptual advice. For this reason we opted to find out the outcome of infants of diabetic mothers compared to those mothers who are essentially normal with no associated medical or obstetric disorders. Equally we wanted to see if there are differences in the outcome of infants born to pre-gestational and gestational diabetic mothers.

Official Title
-----------------
Study of Outcome of Infants of Diabetic Mothers in a Tertiary Hospital Set up

Conditions
-----------------
Pregnancy in Diabetes, Fetal Complications

Intervention / Treatment
-----------------
* Other: Prevention of complications in infants of diabetic mothers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:All infants born to diabetic mothers Infants born to mothers with normal pregnancies Exclusion Criteria: Infants born to mothers with other medical disorders before or during pregnancy which may affect the newborn

Ages Eligible for Study
-----------------
Minimum Age: 1 Hour

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Prevention of complications in infants of diabetic mothers|strict glycemic control in diabetic pregnancies|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Congenital malformations | Assess presence of congenital malformations in infants of diabetic mothers | At time of first clinical examination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | To assess the length of hospital stay for infants of diabetic mothers | Until discharge from hospital or death | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NICU
Oxidative Stress and Hemodialysis Access Failure

Study Overview
=================
Brief Summary
-----------------
Complications of hemodialysis access are the most frequent single reason for hospitalization among patients with End Stage Renal Disease (ESRD). Uremia, and particularly uremia in patients with diabetes, is a state of increased oxidative stress. The central hypothesis to be tested by this project is that oxidative stress is a major (and modifiable) trigger for vascular access complications. We hope to slow or reduce rates of stenosis, thrombosis and access complications by giving Vitamin E supplementation to patients being treated by hemodialysis.

Detailed Description
-----------------
Patients continued their usual treatment on hemodialysis three times per week. This was a double-blinded placebo controlled trial. Patients took either Vitamin E 400 IU bid or placebo. An initial evaluation of access patency was performed and baseline blood drawn before starting Vitamin E. Every 3 months there was a followup evaluation with blood drawn for oxidative stress markers, and with a test of vascular access patency. The study was closed to new participants, vitamin E or placebo stopped, and data analysis performed in 2003.

Official Title
-----------------
Study of the Effect of Oral Supplementation With Vitamin E on Circulating Oxidative Markers, Hemodialysis Vascular Access Occlusion, and Clinical Events in Patients With End Stage Renal Failure Treated by Hemodialysis

Conditions
-----------------
End Stage Renal Disease, Hemodialysis

Intervention / Treatment
-----------------
* Drug: Alpha tocopherol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults, end stage renal disease treated by hemodialysis, patent hemodialysis vascular access (graft or fistula) Exclusion Criteria: Temporary catheter dialysis access, inability to be compliant with study medication

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Alpha tocopherol|nan|

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
-----------------
End stage renal disease treated by hemodialysis, Hemodialysis vascular access patency, Vitamin E, oxidative markers, pentosidine, hydroxynonenal, levuglandin
Evaluation of Deployment Capability and Accuracy of an Outside the Scope (OTS), Detachable Catheter System for Ablation of Peripheral Lung Lesions: An Ex-Vivo Human Lung Model Study

Study Overview
=================
Brief Summary
-----------------
A novel OTS detachable probe system carried outside and along the flexible bronchoscope has been developed. Using this novel system, the operator can deploy the probe in the target bronchus and lesion and completely detach the scope from the probe.

Detailed Description
-----------------
Lung ablative therapies have growing interest in the treatment of early-stage primary lung cancer in surgical high-risk patients and as part of multimodal treatment in patients with large lesions or metastatic malignant disease in the lungs. Endobronchial ablative strategies allow deliver y of these therapies through a natural orifice and minimally invasive approach, potentially improving safety and reducing related morbidity. Application and deployment of this system allows the operator to have constant control of the airway, preventing life-threatening hemoptysis and other complications. We hypothesize that this novel detachable OTS system can be successfully deployed in the peripheral parenchymal target with potential clinical applications in the near future.

Official Title
-----------------
Evaluation of Deployment Capability and Accuracy of an Outside the Scope (OTS), Detachable Catheter System for Ablation of Peripheral Lung Lesions: An Ex-Vivo Human Lung Model Study

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Device: Outside the Scope (OTS), Detachable Catheter System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who follow surgery for the removal of diseased lungs before being submitted to a bilateral lung transplant. Exclusion Criteria: None
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: Système de cathéter détachable dehors du scope (DDS)<br> | Device: Outside the Scope (OTS), Detachable Catheter System<br>* Evaluation of Deployment Capability and Accuracy of an Outside the Scope (OTS), Detachable Catheter System for Ablation of Peripheral Lung Lesions: An Ex-Vivo Human Lung Model Study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accuracy of the deployment method | will be measured by bidimensional fluoroscopy images (antero-posterior and latero-lateral). The deployment will be considered successful if the tip of the probe is positioned at a distance less than 5 mm in both axes from the target model and stay stable in place over 5 minutes of ventilation. | Time of procedure |
Controlled Release of Oxycodone 10 mg In Pre-Medication For The Post Operative Analgesia In Elective Laparoscopic Bilateral Inguinal Hernia And Elective Laparoscopic Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
A Prospective Double Blind RCT: Controlled Release Oxycodone 10 mg On a 12 h Dosing Schedule Started With The Premedication ,Placebo Controlled Study,On Post Operative Analgesia Management in Laparoscopic Cholecystectomy and Laparoscopic Bilateral Inguinal Hernia (BIH). CRO is indicated for the management of moderate to severe pain when a continuous,around the clock analgesic is needed for an extended period of time.Its safety and efficacy in the first 12-24 hours post operative has not been established.

Official Title
-----------------
Controlled Release of Oxycodone 10 mg In Pre-Medication For The Post Operative Analgesia In Elective Laparoscopic Bilateral Inguinal Hernia And Elective Laparoscopic Cholecystectomy : Prospective Double Blind, Randomized, Placebo-Controlled Study

Conditions
-----------------
Elective Laproscopic Bilateral Inguinal Hernia, Elective Laproscopic Cholecystectomy

Intervention / Treatment
-----------------
* Drug: Oxycodone 10 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Local ethic committee approval Written informed consent ASA physical status I-III, scheduled for elective laparoscopic cholecystectomy and elective laparoscopic BIH Exclusion Criteria: Difficulty in communication Allergy to oxycodone and/or morphine Allergy to local anesthetic History of alcohol and substance abuse Treated depression Chronic use of opioid or tramadol or NSAIDS Pregnancy Obstructive sleep apnea Anticipated fiber optic intubation Severe hepatic or renal impairment Weight <50 kg or > 100 kg Conversion to laparotomy Patient extubated in PACU. Any prior abdominal surgery

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Oxycodone 10 mg|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 250 mg/5 ml Oral Suspension Fed Conditions

Study Overview
=================
Brief Summary
-----------------
To demonstrate the relative bioequivalence of Cefdinir and Omnicel 250 mg/5 ml fed conditions.

Official Title
-----------------
A Single Center, Open, Randomized, 2-Way, 2-Period, 2-Sequence Crossover Study of the Bioequivalence of 250mg/5 ml Cefdinir (Test Formulation) and Omnicel 250mg/5 ml Powder For Oral Suspension (Reference Formulation) Each Given as a Single Oral Dose to Forty Healthy Male and/or Female Volunteers in the Fed State

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Cefdinir 250 mg/5 ml Suspension (Sandoz, Austria)
* Drug: Omnicef Cefdinir 250 mg/5 ml Suspension (Abbott Laboratories, USA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 56 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Cefdinir 250 mg/5 ml Suspension (Sandoz, Austria) | Drug: Cefdinir 250 mg/5 ml Suspension (Sandoz, Austria)<br> <br> |
| Active Comparator: 2<br>Omnicef Cefdinir 250 mg/5 ml Suspension (Abbott Laboratories, USA) | Drug: Omnicef Cefdinir 250 mg/5 ml Suspension (Abbott Laboratories, USA)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 15 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antibiotic
Fetal Cell Analysis From Maternal Blood

Study Overview
=================
Brief Summary
-----------------
The aim of this clinical study is the evaluation of clinical performance of a cell-based non-invasive test technology for fetal aneuploidies and segmental imbalances detection in a high-risk pregnancies population.

Official Title
-----------------
Validation of a Cell-Based Technology for Non-Invasive-Prenatal-Diagnosis (CB-NIPD) Using Circulating Whole Fetal Cells From Maternal Peripheral Blood.

Conditions
-----------------
Prenatal Screening, Pregnancy Related, Genetic Disease

Intervention / Treatment
-----------------
* Other: Cell-based non-invasive prenatal testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant has a viable singleton or twin pregnancy Women who have already been selected by their treating physician to undergo an invasive fetal diagnostic procedure Participant is at least 18 years old and can provide informed consent Exclusion Criteria: Unable to provide informed consent Prenatal diagnosis of clinical Chorioamnionitis Intake of drugs or exposure to teratogenic agents Infections that carry a risk of vertical transmission Known maternal viral diseases: HIV and HCV, HBV

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

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

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 |
| --- | --- |
| Other: Blood samples from pregnant women<br>Samples of peripheral blood collected from pregnant women undergoing CVS or genetic amniocentesis | Other: Cell-based non-invasive prenatal testing<br>* Blood sampling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fetal chromosomal abnormalities detection in circulating fetal cells, | Evaluation of clinical performance of a cell-based technology for fetal chromosomal abnormalities detection in circulating fetal cells, using maternal blood samples from a population of high-risk pregnancies undergoing clinically indicated fetal diagnostic procedures. | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of suitable fetal cells | Determination, for each participant sample, of the number of intact fetal cells recovered that are suitable for downstream analysis. | 2 year | 
| Fetal sex assessment | Early, non-invasive fetal sex assessment | 2 year |
A Study to Evaluate the Safety and Effectiveness of WF10 Given to Patients With Late-Stage HIV Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if it is safe and effective to give WF10 to adults with late-stage HIV disease. WF10 is suspected to help the immune system fight infection and slow HIV disease progression.

Detailed Description
-----------------
Patients are randomized to 1 of 2 treatment groups to receive 4 IV treatment cycles of either WF10 or control (physiological saline solution). Patients are monitored throughout the study for: a) clinical progression; b) number, duration, and cause of hospitalizations; c) quality of life; and d) density of CD38 antigen on CD8+ T cells. Patients receive treatment for 11 weeks but will continue to be followed for a maximum of 96 weeks. During the follow-up period, patients are evaluated initially at Week 18, then at Weeks 24, 36, and 48. If the study is continued beyond Week 48, follow-up visits are conducted at Weeks 72 and 96.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Pivotal Clinical Study Evaluating the Safety and Efficacy of WF10 (TCDO) Intravenous Solution in the Management of Patients With Late-Stage HIV Disease

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: WF10


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients may be eligible for this study if they: Are HIV-positive. Have a CD4 cell count of less than 50 cells/mm3 within 14 days prior to study entry. Are at least 18 years old. Have received anti-HIV drugs at some time in the past. Agree to practice abstinence or use effective methods of birth control, including the pill, during the study. Exclusion Criteria Patients will not be eligible for this study if they: Are being treated for any form of cancer within 30 days of study entry. Have ever received an HIV vaccine. Have received steroids within 30 days prior to study entry. (Note: Testosterone is allowed.) Have received certain medications, including anti-HIV treatments that are not approved by the FDA. Have participated in another WF10 study. Have an illness or any condition that might exclude them from this study. Are pregnant or breast-feeding. Abuse drugs or medications. Received a blood transfusion within 45 days prior to study entry.

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: WF10|nan|

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
-----------------
Placebos, Infusions, Intravenous, Quality of Life, Anti-HIV Agents, tetrachlorodecaoxide