linjc16/ctgov huggingface dataset:
A Study of Viracept in HIV-Positive Women

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if it is safe and effective to give Viracept plus stavudine (d4T) plus lamivudine (3TC) to HIV-positive women with a CD4 count <= 400 cells/mm3. This study also examines how the body handles Viracept when given with d4T and 3TC.

Official Title
-----------------
A Phase II, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Viracept in Combination With Antiretroviral Therapy in HIV Positive Women With <= 1 Month of Prior Treatment With d4T and/or 3TC

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

Intervention / Treatment
-----------------
* Drug: Nelfinavir mesylate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: HIV infection. CD4 T cell count <= 400 cells/mm3. Exclusion Criteria Prior Medication: Excluded: Prior therapy or less than 1 month of therapy with d4T and/or 3TC. Prior protease inhibitor therapy.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nelfinavir mesylate|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, Drug Therapy, Combination, Stavudine, HIV Protease Inhibitors, Lamivudine, Nelfinavir, Anti-HIV Agents
Infection After Free Fibula Flap Reconstruction of the Mandible: a Retrospective Cohort Study

Study Overview
=================
Brief Summary
-----------------
Mandibular osteitis after flap reconstruction is rare but is a serious infection with significant sequelae. The aim of this study is to describe this type of infection

Official Title
-----------------
Infection After Free Fibula Flap Reconstruction of the Mandible: a Retrospective Cohort Study

Conditions
-----------------
Bone and Joint Infection

Intervention / Treatment
-----------------
* Other: failure of reconstruction of the mandibule by free fibula flap


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients having had infection after a free bony flap reconstruction of the mandibule treated as an osteomyelitis at the CRIOAc between 2014 and 2020 Exclusion Criteria: non-bony flap

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| description of infection of free fibula flap reconstruction<br> | Other: failure of reconstruction of the mandibule by free fibula flap<br>* description of failure of reconstruction of the mandibule by free fibula flap:delay, type of bacteria involved in the failure, treatment, outcome<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of failure after free fibula flap reconstruction of the mandible | description of failure after free fibula flap reconstruction of | Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of bacteria involved in failure after free fibula flap reconstruction of the mandible | epidemiology of bacteria which causes the failure | when bacteria had growth up on culture; usually 2-3 weeks after the sample extracted on the surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mandibular, flap
Collection of Blood for Multiple Collaborative Studies

Study Overview
=================
Brief Summary
-----------------
This study seeks to confidentially collect blood from HIV-positive individuals and HIV-negative controls to provide basic scientists with specimens for collaborative studies.

Detailed Description
-----------------
HIV positive patients are currently the focus of multiple collaborative research studies, both at UCSF and other institutions. The aims of these research projects include improving the understanding of etiology, immunology, epidemiology and treatment of HIV. There are numerous requests from basic scientists at UCSF for collaborative studies on specimens, especially for blood, saliva and urine samples. Specimens may be used to test such things as virus characteristics, genotyping and/or phenotyping resistance, plasma drug concentrations, immune function or evidence of complications of HIV disease. The samples may also be tested for genetic factors that may be related to the course of HIV disease

Official Title
-----------------
Collection and Preservation of Blood and Serum Specimens From HIV Positive or HIV Negative Patients for Multiple Collaborative Studies

Conditions
-----------------
HIV

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-1 antibody negative with similar characteristics to HIV-1 positive cohort HIV-positive subjects naive to antiretroviral therapy HIV-positive subjects stable on or off antiretroviral therapy for a minimum of 6 months Good venous access Able to provide informed consent Exclusion Criteria: Hemoglobin < 9g/dl Hematocrit < 27% Active treatment for cancer Hospitalization or IV antibiotic use within the last 4 months Immunosuppressive therapy within the last 4 months

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV Positive<br>HIV-1 positive subjects | |
| HIV negative subjects<br>HIV-1 seronegative control group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma HIV RNA level | Viral load | Ongoing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Observational, Pathogenesis, Immunology, Virology, Control, Healthy control, Men who have sex with men
Effectiveness Chronic Kidney Disease & Therapeutic Exercise

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effectiveness and safety of the therapeutic exercise effects in patients with chronic kidney disease. An randomized clinical trial is carried out. A total sample of 70 patients with chronic kidney disease is recruited and divided into a therapeutic exercise group and a control group. The kidney function (creatinine clearance as main outcome) is measured at baseline and 1 month after treatment start.

Official Title
-----------------
Effectiveness and Safety of the Therapeutic Exercise in Patients With Chronic Kidney Disease

Conditions
-----------------
Kidney Diseases, Exercise

Intervention / Treatment
-----------------
* Other: Therapeutic Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with chronic kidney disease Exclusion Criteria: Cognitive impairment and non signed consent inform form

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapeutic exercise<br> | Other: Therapeutic Exercise<br>* 30 minutes per day of therapeutic exercise<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kidney function | Creatinine clearance | Change from Baseline creatinine clearance at 1 month |
Safety of a New Security Device in Patients With Implanted Cardiac Electronic Devices

Study Overview
=================
Brief Summary
-----------------
Patients with implantable cardiac electronic devices will be exposed to a new safety device and evaluated for potential electromagnetic interference.

Detailed Description
-----------------
Patients with implanted pacemakers or defibrillators will undergo a screening procedure with an innovative security device. Evaluation will be made with respect to the occurrence of interference.

Official Title
-----------------
Safety of a New Security Device in Patients With Implanted Cardiac Electronic Devices

Conditions
-----------------
Electromagnetic Interference

Intervention / Treatment
-----------------
* Other: Security screening procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: implantable pacemaker or defibrillator in situ Exclusion Criteria: malfunction of implantable pacemaker or defibrillator low battery voltage of implanted cardiac electronic device

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
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective cohort study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Exposition to safety screening<br>One armed study with exposition to a new safety device (model QPS100) using radiofrequency technology | Other: Security screening procedure<br>* Screening procedure with security device (model QPS 100)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electromagnetic interference | Occurrence of electromagnetic interference | 10 minutes |
The Air Test: A New Simple, Non-invasive Method to Diagnose Anesthesia-induced Atelectasis

Study Overview
=================
Brief Summary
-----------------
Anesthesia-induced atelectasis persist in the postoperative period but are not usually diagnosed because imaging techniques are required. The aim of the study is to determine whether the value of SpO2≤96 while breathing room air (0.21 FiO2) for 5 min, maneuver that we defined as the Air Test, was able to diagnose atelectasis in the postoperative period after a general anesthesia.

Official Title
-----------------
Estudio de validación de la pulsioximetría Como método diagnóstico no Invasivo de Atelectasia Pulmonar y de la Efectividad de la Maniobra de Capacidad Vital Para la reversión de la Atelectasia Durante el Postoperatorio

Conditions
-----------------
Patients With ASA Status I-III Scheduled for Elective Surgery

Intervention / Treatment
-----------------
* Procedure: Air Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-III Scheduled for elective surgery Exclusion Criteria: age of <18 years pregnant women previous lung resection local-regional anesthesia cardio-thoracic anesthesia preoperative room air SpO2 less than 97%

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 |
| --- |
|Procedure: Air Test|The Air Test simply consisted in breathing room air for 5 min on arrival into the postoperative anesthesia care unit while measuring peripheral oxygen saturation by Pulse oximetry|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of postoperative atelectasis meassured by SpO2 levels and confirmed by computed tomography. | After arrival to the post-surgery unit, patients received supplemental oxygen through a venturi mask with flow adjusted to approximate a FiO2 of 0.5 during the first 30 minutes. The SpO2 measure was made removing the oxygen mask and leaving the patients to breath room air for at least for 5 minutes. | 35 minutes post-surgery |
Pharmacokinetic-pharmacodynamic Assessment of Seresis® in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
Study to determine the antioxidant potency of Seresis® in the serum of healthy volunteers and the optimal time for blood sampling

Official Title
-----------------
Pharmacokinetic-pharmacodynamic Assessment of Seresis® o.d.: an Open, Uncontrolled, Non-randomised Intraindividual Pilot-study

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

Intervention / Treatment
-----------------
* Drug: Seresis®
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subjects to be enrolled are healthy volunteers, defined as follows: Healthy men or women between 18 and 30 years old Non-smokers Fit for work Having given informed consent and signed the form Exclusion Criteria: Any serious disorder that might interfere with his/her participation in this study and the evaluation of the safety of the test drug (e.g. renal insufficiency, hepatic dysfunction, cardiovascular disease, hypervitaminosis A, psychic disorder etc.). Treatment with other drug that might interfere with the evaluation of the safety of the test drug Known hypersensitivity to any of the ingredients of the study drug Pregnancy, lactation, women of childbearing potential who do not use an established contraceptive Drug and alcohol abuse Participation in another trial Known abnormal values of the laboratory tests (if detected after enrolment, subjects will continue the treatment provided there are not medical objections) Specific dietary requirements that do not allow the volunteers to meet the dietary guidelines set out for this study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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

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: Seresis® + Placebo<br>2 capsules Seresis® o.d. for 5 days 2 capsules Placebo o.d. the day before treatment with Seresis® | Drug: Seresis®<br> <br> Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in total antioxidant activity of Seresis® | determined by chemoluminescence | Baseline, Day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in total antioxidant activity of Seresis® | determined by chemoluminescence | Day 2, day 6 | 
| Assessment of tolerability on a 4-point scale |  | Day 14 | 
| Number of patients with abnormal changes in laboratory parameters |  | up to day 14 | 
| Number of patients with adverse events |  | up to day 14 |
A Multi-Center, Observational Registry of Subjects With Secondary Hyperparathyroidism (HPT) and Chronic Kidney Disease (CKD)

Study Overview
=================
Brief Summary
-----------------
Objectives include description of current practices; assessment over time of K/DOQI goals, clinical outcomes, health resource utilization(HRU) and patient reported outcomes (PRO) and the impact of Sensipar® on these parameters

Official Title
-----------------
A Multi-Center, Observational Registry of Subjects With Secondary Hyperparathyroidism (HPT) and Chronic Kidney Disease (CKD)

Conditions
-----------------
Nephrology

Intervention / Treatment
-----------------
* Drug: Sensipar®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 3 month history of Stage 4 or Stage 5 CKD A PTH value within 3 months of enrollment If relevant, completion of Sensipar® study prior to enrolling in Registry Exclusion Criteria: Females who are pregnant or breast feeding

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 |
| --- |
|Drug: Sensipar®|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
-----------------
Chronic Kidney Disease, CKD,, Secondary Hyperparathyroidism, HPT
Retrospective Evaluation of ASIPP Guidelines Implementation

Study Overview
=================
Brief Summary
-----------------
To demonstrate clinically significant improvements in the patients treated following ASIPP guidelines compared to the patients who were treated prior to the establishment of ASIPP guidelines.

Detailed Description
-----------------
We have performed one study in the past showing that the implementation of guidelines improved outcomes by reducing the number of procedures and also the cost. However,, no large scale study has been performed thus far.

Official Title
-----------------
Evaluation of the Effectiveness of Implementation of American Society of Interventional Pain Physician Guidelines for Interventional Techniques: A Retrospective Evaluation

Conditions
-----------------
Guideline Implementation

Intervention / Treatment
-----------------
* Procedure: American Society of Interventional Pain Physician Guidelines


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Evaluate all patients undergoing the following interventional techniques during 1999 and 2000 compared to patients undergoing interventional techniques during 2004 and 2005 Cervical facet joint nerve blocks Thoracic facet joint nerve blocks Lumbar facet joint nerve blocks Lumbar interlaminar epidural steroid injections Cervical interlaminar epidural steroid injections Exclusion Criteria: Non-availability of appropriate data
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: American Society of Interventional Pain Physician Guidelines|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
-----------------
ASIPP, Guidelines
Real-World Evaluation Screening Study and Registry of Dyskinesia in Patients Taking Antipsychotic Agents

Study Overview
=================
Brief Summary
-----------------
Prospective study to quantify the prevalence of possible tardive dyskinesia (TD) in outpatient psychiatry practices in the United States (US), as well as to describe the associated disease burden in a cohort of patients with one or more psychiatric disorders and a cumulative lifetime exposure to antipsychotic medication of three months or more.

Official Title
-----------------
Real-World Evaluation Screening Study and Registry of Dyskinesia in Patients Taking Antipsychotic Agents

Conditions
-----------------
Tardive Dyskinesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has a cumulative lifetime exposure to antipsychotic medication of three months or more Patient has a clinician confirmed diagnosis of one or more psychiatric disorder(s), as defined in the DSM-5 Patient has a usual care clinic visit scheduled during the study recruitment window (i.e. a pre-defined 2-week period) Patient is able to read and understand English Patient is willing and able to comply with the study requirements Exclusion Criteria: Patient is unable to provide informed consent.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Patients without visible signs of involuntary movements (possible TD) at time of clinician assessment | |
| Cohort 2<br>Patients with visible signs of involuntary movements (possible TD) at the time of clinician assessment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Customized clinician-reported outcomes | Clinician evaluation of patient burden due to tardive dyskinesia symptoms | 12 months | 
| EuroQOL 5 Dimensions EQ-5D-5L) | General, single index measure for describing and valuing health-related quality of life. | 12 months | 
| Customized caregiver-reported outcomes: | Caregiver evaluation of perceived burden of symptoms on patients as well as the impact on the caregiver | 12 months | 
| Sheehan Disability Scale (SDS) | Assessment of functional impairment and disability | 12 months |