linjc16/ctgov huggingface dataset:
Safety and Efficacy of the Effect of Isosorbide Mononitrate in Reducing Pain During Levonorgestrel-releasing Intrauterine Device Insertion

Study Overview
=================
Brief Summary
-----------------
the aim of the study is to evaluate the safety and efficacy of isosorbide mononitrate vaginal administration in reducing pain during LNG-IUD insertion in adolescents and young women

Official Title
-----------------
Safety and Efficacy of the Effect of Isosorbide Mononitrate in Reducing Pain During Levonorgestrel-releasing Intrauterine Device Insertion in Adolescents and Young Women

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Drug: Isosorbide Mononitrate 40 MG
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adolescents and young women requesting LNG-IUD insertion Exclusion Criteria: heavy vaginal bleeding,pregnancy, contraindications to IUD insertion, allergy or contraindication to isosorbide mononitrate, uterine anomaly

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 25 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Isosorbide Mononitrate<br>one tablet of Isosorbide Mononitrate (40 mg) vaginally 3 hours prior to LNG-IUD insertion | Drug: Isosorbide Mononitrate 40 MG<br>* one tablet of Isosorbide Mononitrate (40 mg) vaginally 3 hours prior to LNG- IUD insertion<br>|
| Placebo Comparator: placebo<br>one tablet of placebo vaginally 3 hours prior to LNG- IUD insertion | Drug: Placebo<br>* one tablet of placebo vaginally 3 hours prior to LNG-IUD insertion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain during IUD insertion | intensity of patient-perceived pain at time of IUD insertion, using a visual analog scale. The VAS scale is graded from 0 to 10 on a 10 cm horizontal straight line, where 'zero' corresponds to no pain at all, and '10' to the worst possible pain imaginable. | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of IUD insertion | duration of IUD insertion from speculum in to speculum out in minutes | 5 minutes |
Neurobiological, Neuropsychological,Linguistic and Gestural Processes and Phenomena in Individuals With Alexithymia

Study Overview
=================
Brief Summary
-----------------
The syndrome of extremely restricted emotional competence, alexithymia, was originally conceptualized in psychoanalytic research and is now empirically and experimentally studied in clinical psychology and psychological medicine within the context of emotion regulation using neuroscientific techniques. Alexithymia refers to an individual's inability or impaired ability to name or express feelings and to distinguish them from the physical consequences of an acute or chronic stress reaction. Modern brain-body-interface research suggests that alexithymia represents a complex deficiency in cognitive processing and emotional regulatory processes. The neurobiological basis is assumed to be a preconscious, automatic and involuntary information transfer to the amygdalae of acquired representations of emotional contents stored in ventromedial prefrontal cortical areas. Alexithymia is not just emotional coldness, i.e. a limited emotionality, but essentially the detachment of feelings from language. In alexithymia the link between affective phenomena and language, understood as media-supported sign practices, is insufficient or even absent. The purpose of our observational study is to better understand the neurobiological and neuropsychological as well as linguistic and gestural processes and determinants of this phenomenon

Official Title
-----------------
Understanding Alexithymia

Conditions
-----------------
Alexithymia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: scoring high on the TAS-20 Exclusion Criteria: personal history of a mental disorder currently mentally ill

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
alexithymia
Safety, Feasibility, and Tolerability of Sulforaphane in Children With Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
This purpose of this study is to investigate potential new therapeutics in pediatric chronic kidney disease (CKD). The specific aims are to identify safe dosing and tolerability of sulforaphane (SFN) supplementation in children with moderate and advanced CKD. Secondary objectives will include preliminary exploration of changes in oxidative and inflammatory biomarkers in response to SFN supplementation in this population.

Official Title
-----------------
Safety, Feasibility, and Tolerability of Sulforaphane in Children With CKD

Conditions
-----------------
Pediatric Kidney Disease

Intervention / Treatment
-----------------
* Drug: Sulforaphane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of chronic of kidney disease have eGFR 20-59 mL/min/1.73m2 at the time of enrollment parents must be able to provide consent Exclusion Criteria: weight <30 kg cancer or HIV diagnosis history of solid organ transplantation (including kidney transplant) structural heart disease currently pregnant or plan to become pregnant life expectancy is less than one year Patients will also be excluded if they are currently taking anticoagulants, immunosuppression, or chemotherapeutics

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 17 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 |
| --- | --- |
| Active Comparator: Group 1<br>30-50 lbs; 1 tablet (30mg/d) 50-70 lbs; 2 tablets (60mg/d) 70-90 lbs; 3 tablets (90mg/d) >90 lbs; 4 tablets (120 mg/d) | Drug: Sulforaphane<br>* Dosing study one to four 30 mg/d tablets depending on weight<br>|
| Active Comparator: Group 2<br>30-50 lbs; 1 tablet (30mg/d) 50-70 lbs; 1 tablet (30mg/d) 70-90 lbs; 2 tablets (60mg/d) >90 lbs; 2 tablets (60 mg/d) | Drug: Sulforaphane<br>* Dosing study one to four 30 mg/d tablets depending on weight<br>|
| Active Comparator: Group 3<br>30-50 lbs; 1 tablet (30mg/d) 50-70 lbs; 1 tablet (30mg/d) 70-90 lbs; 1 tablet (30mg/d) >90 lbs; 1 tablet (30 mg/d) | Drug: Sulforaphane<br>* Dosing study one to four 30 mg/d tablets depending on weight<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean half life of drug in blood |  | 8 hours | 
| mean maximum concentration of drug in blood |  | 8 hours | 
| mean area under the curve of drug concentration in blood |  | 8 hours |
A Study Of Adjunctive Treatment Of Cognitive Deficits In Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the safety, tolerability, and efficacy of two dose regimens of PF-3463275 compared with placebo added to ongoing atypical antipsychotic therapy for cognitive deficits in subjects with chronic symptoms of schizophrenia.

Official Title
-----------------
A Phase 1B Inpatient, Randomized, Double-Blind, Placebo-Controlled, Crossover Study Of The Safety And Efficacy Of Two Fixed Doses Of PF-3463275 In Adjunctive Treatment Of Cognitive Deficits In Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: PF-3463275
* Drug: PF-3463275
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of schizophrenia In stable treatment with risperidone, olanzapine, quetiapine, ziprasidone, aripiprazole, or paliperidone for at least 2 months Stable symptoms of schizophrenia for at least 3 months. Exclusion Criteria: Subjects with a psychiatric disorder other than schizophrenia Substance dependence or abuse Women who have child bearing potential.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: PF-3463275<br>* PF-3463275 10mg<br>|
| Experimental: 2<br> | Drug: PF-3463275<br>* PF-3463275 25mg<br>|
| Placebo Comparator: 3<br> | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the CNS Vital Signs Cognition Battery composite score |  | 6 days | 
| Safety Endpoints: tolerability, laboratory tests, vital signs, and ECG's. |  | 38 days | 
| Pharmacokinetics of PF-3463275 |  | 6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive and Negative Syndrome Scale (PANSS) |  | 6 days | 
| Change from baseline in the CNS Vital Signs Cognition Battery domain scores |  | 6 days |
Assess the Immunogenicity of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine

Study Overview
=================
Brief Summary
-----------------
Evaluate the immune response of GSK Biologicals' 10-valent pneumococcal conjugate vaccine one month after completion of a 3-dose primary vaccination course administered at 2, 3, 4 months of age

Detailed Description
-----------------
Test groups: 2 groups (60 subjects/group). 10Pn-PD-DiT group receiving GSK Biologicals' 10-valent pneumococcal conjugate vaccine + DTPa-HBV-IPV/Hib; Control group receiving Prevenar + DTPa-HBV-IPV/Hib

Official Title
-----------------
Phase IIIa Randomized, Controlled Study to Assess the Immunogenicity of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine, When Administered as a 3-dose Primary Immunization Course Before 6 Months of Age

Conditions
-----------------
Infections, Streptococcal, Streptococcus Pneumoniae Vaccines

Intervention / Treatment
-----------------
* Biological: Pneumococcal (vaccine)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Male or female between, and including, 8 and 16 weeks (56-118 days) of age at the time of the first vaccination, free of obvious health problems and with written informed consent obtained from the parent/guardian of the subject. Exclusion criteria: Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. Planned administration/ administration of a licensed vaccine not foreseen by the study protocol during the period starting from one month before the first dose of vaccine(s) and during the entire study period.

Ages Eligible for Study
-----------------
Minimum Age: 8 Weeks
Maximum Age: 16 Weeks

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Pneumococcal (vaccine)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1 month post-dose 3: Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations >= 0.20 µg/mL |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1 month post dose 3: For all vaccine pneumococcal serotypes: Opsono titres |  |  | 
| Antibody (Ab) concns >= 0.05 µg/mL |  |  | 
| Ab concns to protein D and seropositivity (S+) status |  |  | 
| S+/seroprotection status to antigens in DTPa-HBV-IPV/Hib vaccine |  |  | 
| After each vaccination, occurrence of: solicited local, general symptoms within 4 days |  |  | 
| Unsolicited adverse events within 31 days, SAEs (whole study period) |  |  |
A Study of ABT-751 in Patients With Renal Cell Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine if ABT-751 will decrease tumors, and determine how long the tumor shrinkage can be maintained in patients with renal cell cancer. Patients will receive ABT-751 by mouth daily for 21 days. Patients will be off drug for 7 days before starting the next cycle of drug.

Official Title
-----------------
A Phase 2 Study of ABT-751 in Subjects With Refractory Colorectal Carcinoma

Conditions
-----------------
Renal Cell Cancer

Intervention / Treatment
-----------------
* Drug: ABT-751


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Renal Cell Carcinoma. Recurrent tumor. At least 6 weeks post-nephrectomy. Able to tolerate normal activities of daily living. Adequate bone marrow, kidney, and liver function. Exclusion Criteria Pregnant or breast feeding. Anti-tumor therapy within 4 weeks of the start of ABT-751 administration. CNS metastasis.

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: ABT-751|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate in subjects with RCC |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Tumor Progression (TTP) |  | 1 year | 
| Survival |  | 2 years | 
| Toxicities associated with treatment administration |  | 1 year |
Study to Compare CAUTI Rates Following ERASE CAUTI Tray Non-Silver vs Silver Coated Foley Catheters

Study Overview
=================
Brief Summary
-----------------
The Foley catheter is one component in a catheter insertion procedure that could contribute to a catheter associated urinary tract infection (CAUTI). Improvement in the catheter insertion procedures using the ERASE CAUTI Tray system may help to lower these infection rates.

Official Title
-----------------
A Clinical Study to Compare the CAUTI Rates Following ERASE CAUTI Tray Non-Silver Coated Foley Catheters Verse Silver Coated Foley Catheters

Conditions
-----------------
Surgery, Intensive Care Units

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age Received Either silver coated Foley catheter or ERASE CAUTI non-silver coated catheter Exclusion Criteria: UTI present upon current hospital admission Burn patients, transplant patients, or immune-compromised patients.

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 |
| --- | --- |
| Silver Coated Catheters<br>Subjects that had previously received silver coated Foley catheters. | |
| ERASE CAUTI Non-Silver Coated Catheters<br>Subjects that received non-silver catheters from an ERASE CAUTI tray. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Urinary tract infection rates | Infection rate/1000 catheter days. | 3-9 months based on size of ICU and catheter usage | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Catheter use | Number of days catheters used. | Catheter days | 
| Infection Costs | Catheter related charges for infections | Duration of infection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Foley, Catheters, CAUTI, ERASE CAUTI
Registry to Evaluate Efficacy of Xience/Promus Versus Cypher in Reducing Late Loss After Stenting

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the safety and long-term effectiveness of coronary stenting with the everolimus-eluting stent (EES) and to determine clinical device and procedural success during commercial use of EES in the real world. The investigators will compare EES (Xience/Promus, prospective arm) with sirolimus-eluting stent (SES, Cypher, retrospective arm).

Official Title
-----------------
EXCELLENT (Efficacy of Xience/Promus Versus Cypher in rEducing Late Loss After stENTing) Registry

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: Xience/Promus
* Device: Cypher


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient agrees to participate in this study by signing the informed consent form. Alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form. Exclusion Criteria: There are no exclusion criteria for this registry.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Xience/Promus<br>Active prospective registration of patients receiving everolimus eluting stent | Device: Xience/Promus<br>* Active prospective registration of patients receiving everolimus-eluting stent<br>* Other names: EES;|
| Cypher<br>Retrospective historical controls that received sirolimus-eluting stent | Device: Cypher<br>* Retrospective historical controls that received sirolimus-eluting stent<br>* Other names: SES;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac Events (composite of cardiac death, non-fatal MI, target lesion revascularization) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-stent & In-segment Late Loss |  | 9 months | 
| Stent Thrombosis |  | 1 year | 
| Target Vessel Failure (composite of cardiac death, MI, and TVR) |  | 12 months | 
| Any death, cardiac death, MI, TLR, TVR |  | 1 year | 
| Composite rate of cardiac death and any MI |  | 1 year | 
| Composite rate of all death and any MI |  | 1 year | 
| Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization |  | 1 year | 
| Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy |  | 1 year | 
| Clinical device and procedural success |  | During the health care facility stay | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Everolimus, Sirolimus, Drug eluting stent
Full-Leg vs Below-Knee Elastic Stockings for Prevention of the Post-Thrombotic Syndrome

Study Overview
=================
Brief Summary
-----------------
Prospective controlled randomized clinical trial. Consecutive patients with acute proximal deep vein thrombosis of the lower extremities, with or without contemporary manifestations of pulmonary embolism, are randomized to receive either a below-knee or a full-leg graduated compression (30-40 mm Hg at the ankle) elastic stocking for prevention of the post-thrombotic syndrome (PTS). All patients are followed up to three years to assess the development of the PTS, defined according to a validated clinical score (the Villalta scale). The rate of PTS is compared between the two study groups. In addition, there is an assessment of patients' compliance and tolerability of the two different devices.

Conditions
-----------------
Deep Vein Thrombosis

Intervention / Treatment
-----------------
* Device: Elastic stockings


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First episode of proximal deep vein thrombosis, as shown by compression ultrasound Exclusion Criteria: Previous ipsilateral deep vein thrombosis Preexisting chronic venous insufficiency Bilateral deep vein thrombosis Life expectancy lower than 1 year Severe arteriopathy of the lower limbs Known allergy to elastic stockings Lack of written informed consensus
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Elastic stockings|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
-----------------
Deep vein thrombosis of the lower extremities