linjc16/ctgov huggingface dataset:
Efficacy Study Measuring The Impact Of Treatment With Viagra On The Depressive Symptoms Of Men With Erectile Dysfunction

Study Overview
=================
Brief Summary
-----------------
This study will measure the impact of treatment with Viagra on the depressive symptoms and quality of life in men with erectile dysfunction who have untreated depressive symptoms meeting the DSM-IV criteria for dysthymia or depression not otherwise specified (NOS), including minor depressive symptoms but excluding any form of psychotic disorder.

Official Title
-----------------
A Multi-Center, Flexible Dose Study With A Double-Blind, Randomized, Placebo-Controlled Phase Followed By An Open-Label Phase To Evaluate The Impact Of Treatment With Sildenafil Citrate On The Symptoms Of Depression And Quality Of Life (Qol) Of Male Patients With Erectile Dysfunction (ED)

Conditions
-----------------
Impotence, Depression

Intervention / Treatment
-----------------
* Drug: Viagra (Sildenafil citrate)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men above age of majority with ED (SHIM score less than 21) Beck Depression Inventory II score between 14 and 28 Exclusion Criteria: Subjects with symptoms of mania or major depressive disorders as demonstrated by the Mini International Neuropsychiatric Interview (MINI) Subjects who require treatment with antipsychotics, mood stabilizers, antidepressant agents or lithium (concomitant use of benzodiazepines is allowed) or who has required treatment with any of the above medication within the past 3 months

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

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

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: Viagra (Sildenafil citrate)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe the effect of treatment with sildenafil on the depressive symptoms in subjects with ED as measured by the BDI II at the end of the double-blind phase |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure QoL improvement; Describe treatment effect on social motivation & behavior; Describe relationship between depression severity and ED; Describe effectiveness of sildenafil; Describe correlation between the SEX FX and the IIEF; Validate the PREFA |  |  |
Study Comparing the Safety and Efficacy of Piperacillin/Tazobactam to Cefepime in Patients With Hematologic Malignancy or Lymphoma

Study Overview
=================
Brief Summary
-----------------
To compare the safety and efficacy of piperacillin/tazobactam (4 g/500 mg) administered intravenously every 6 hours to cefepime (2 g) administered intravenously every 8 hours for the empiric treatment of neutropenic fever in patients with a hematologic malignancy or lymphoma.

Official Title
-----------------
A Randomized, Open-Label, Multi-Center, Comparative Study of the Efficacy and Safety of Piperacillin/Tazobactam to Cefepime for the Empiric Treatment of Neutropenic Fever in Patients With a Hematologic Malignancy or Lymphoma

Conditions
-----------------
Hematologic Neoplasms

Intervention / Treatment
-----------------
* Drug: Piperacillin/Tazobactam (Tazocin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized male and female patients, 18 years of age or older Patients who have leukemia (acute lymphocytic leukemia [ALL], acute myelogenous leukemia [AML], chronic lymphocytic leukemia [CLL], chronic myelogenous leukemia [CML]), that is newly diagnosed, who have had initial induction, re-induction, or intensification chemotherapy or who have had a bone marrow (allogenic, syngeneic, or autologous) or peripheral blood stem-cell transplant OR Patients with lymphoma, Hodgkin's disease, multiple myeloma, myelodysplastic syndrome or myelodysplasia (refractory anemia [RA], refractory anemia with ringed sideroblasts [RARS], refractory anemia with excess blasts [RAEB], refractory anemia with excess blasts in transformation to leukemia [RAEB-T], or chronic myelomonocytic leukemia [CMML]. Fever, defined as an oral temperature of ≥ 37.9°C /100.2°F, a rectal temperature ≥ 38.4°C /101.4°F, or a tympanic temperature ≥ 38°C /100.4°F Exclusion Criteria: The presence of any clinically acute or chronic disease or condition that, in the opinion of the investigator, may interfere with the patient's ability to safely comply with the conditions of the protocol, or could preclude the evaluation of the patient's response or could make the completion of the therapy unlikely Neutropenia associated with syndromes that are not associated with a high risk of bacterial infection (eg. chronic benign neutropenia or Kostmann's syndrome) Neutropenia due to primary bone marrow failure

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Piperacillin/Tazobactam (Tazocin)|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
-----------------
Hematologic, Neoplasms
Anlotinib Plus PD-1 Antibody in Standard Chemotherapy Failure Advanced NSCLC： the ATHENA Study

Study Overview
=================
Brief Summary
-----------------
This study aims to explore the efficacy and safety of Anlotinib plus PD-1 antibody in Standard Chemotherapy Failure Advanced Non-small Cell Lung Cancer (Athena study）

Detailed Description
-----------------
This study aims to explore the efficacy and safety of Anlotinib plus PD-1 antibody in Standard Chemotherapy Failure Advanced Non-small Cell Lung Cancer. We aim to enrolled 100 patients in this study, the primary endpoint was PFS.

Official Title
-----------------
Anlotinib Plus PD-1 Antibody in Standard Chemotherapy Failure Advanced Non-small Cell Lung Cancer (Athena Study）

Conditions
-----------------
Non-small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18，Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by Histopathology Standard Chemotherapy Failure Treatment Plan is Anlotinib Plus PD-1 Antibody Exclusion Criteria: Patients with contraindication of chemotherapy Pregnant or breast feeding women

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

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

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 |
| --- | --- | --- |
| PFS | Progression free survival time | may 2020- may 2021 (1 year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Objective response rate | may 2020- may 2021 (1 year) | 
| OS | Over survival time | may 2020- may 2021 (1 year) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anlotinib, PD-1 antibody, NSCLC
Diagnostic Modalities for Severe Odontogenic Infections Using Rapid, Target Enriched Multiplex PCR (TEM- PCR) by Diatherix

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the sensitivity and specificity of the Target Enriched Multiplex (TEM) polymerase chain reaction (PCR) platform for the rapid molecular diagnosis and treatment of odontogenic deep space neck infections.

Official Title
-----------------
Diagnostic Modalities for Severe Odontogenic Infections Using Rapid, Target Enriched Multiplex PCR (TEM- PCR)

Conditions
-----------------
Odontogenic Deep Space Neck Infection

Intervention / Treatment
-----------------
* Diagnostic Test: Target Enriched Multiplex PCR (TEM- PCR)
* Diagnostic Test: Microbial culture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in whom there is clinical and radiographic evidence of an odontogenic deep space neck infection. Exclusion Criteria: Patients with gross communication between the abscess and the oral cavity will be excluded.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects with advanced deep space odontogenic infection<br>Subjects will be diagnosed via two methods: 1. Target Enriched Multiplex PCR (TEM- PCR) and 2. Standard microbial culture. | Diagnostic Test: Target Enriched Multiplex PCR (TEM- PCR)<br>* Target Enriched Multiplex PCR (TEM- PCR) assays will be performed and will probe for the typical array of advanced deep space odontogenic infections, as well as MRSA resistance, clindamycin resistance, and the presence of Panton-Valentine leukocidin (PVL) toxin, a toxin produced by some bacteria.<br>Diagnostic Test: Microbial culture<br>* Standard diagnosis by microbial culture.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity as assessed by number of participants who had matching results between TEM-PCR and standard microbial culture |  | Baseline (at the time the sample was obtained from the patient) |
Patient Comfort During Dermatologic Procedures

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to find the effect of holding a patient's hand on anxiety and pain during dermatologic procedures.

Official Title
-----------------
Managing Patient Comfort During Dermatologic Procedures: A Randomized Controlled Trial

Conditions
-----------------
Anxiety, Pain

Intervention / Treatment
-----------------
* Procedure: Hand-holding
* Procedure: Stress Ball


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 and older Undergoing a dermatologic procedure Willing and able to understand and provide informed consent and communicate with the investigator Exclusion Criteria: Subjects who have wound healing problems Subjects who are unable to understand the protocol or to give informed consent Subjects with self-reported mental illness or other psychological conditions, such as psychotic disorders, mood disorders, anxiety disorders, cognitive disorders, depression with psychotic features, dissociative disorders

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hand-holding<br>Subjects will be randomized to be in the handholding, stress ball, or control study arms. The randomization will be 1:1:1. | Procedure: Hand-holding<br>* Subject will have their hand held.<br>|
| Experimental: Stress Ball<br>Subjects will be randomized to be in the handholding, stress ball, or control study arms. The randomization will be 1:1:1. | Procedure: Stress Ball<br>* Subject will be given a stress ball to hold.<br>|
| No Intervention: Nothing<br>Subjects will be randomized to be in the handholding, stress ball, or control study arms. The randomization will be 1:1:1. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | Subjects will complete the 6-item State-Trait Anxiety Inventory (STAI) | immediately after dermatologic procedure | 
| Pain | Subjects will complete a visual analog scale for pain ranging from no pain at all to worst possible pain. | immediately after dermatologic procedure |
Magnetic Prefrontal Stimulation for Studying the Role of the Cortex in High-level Cognition Processes and Reward System

Study Overview
=================
Brief Summary
-----------------
The investigators intend to study the role of the cortex in high- level cognition processes and sensory adaptation, by the use of non-invasive Transcranial Magnetic stimulation and various cognitive tests.

Official Title
-----------------
Magnetic Prefrontal Stimulation for Studying the Role of the Cortex in High-level Cognition Processes and Reward System

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Device: TMS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy men and women, age of 18-60 answered negatively to questions of TMS safety questionnaire signed and declared about their agreement to participate in the study hebrew speaker Exclusion Criteria: self history of significant mental disorder self history or first-degree relatives history of epilepsy

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LT PFC HIGH FREQ TMS<br> | Device: TMS<br>* TRANSCRANIAL MAGNETIC STIMULATION<br>|
| Active Comparator: LT PFC LOW FREQ TMS<br> | Device: TMS<br>* TRANSCRANIAL MAGNETIC STIMULATION<br>|
| Active Comparator: RT PFC HIGH FREQ TMS<br> | Device: TMS<br>* TRANSCRANIAL MAGNETIC STIMULATION<br>|
| Active Comparator: RT PFC LOW FREQ TMS<br> | Device: TMS<br>* TRANSCRANIAL MAGNETIC STIMULATION<br>|
| Sham Comparator: SHAM STIMULATION<br> | Device: TMS<br>* TRANSCRANIAL MAGNETIC STIMULATION<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in scoring of different tests and questionnaires |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of different tests and questionnaires |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
reward, TMS, cognition, Motivation, Perception, Decision making
A Prospective, Multi-center, Randomized, Blinded Study to Evaluate Durasphere FI for the Treatment of Fecal Incontinence

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate a new injectable bulking agent for the treatment of fecal incontinence in adult men and women. This study has been designed to assess the safety, effectiveness and performance of Durasphere in adults suffering from fecal incontinence under monitored clinical conditions. The frequency and severity of fecal incontinence symptoms will be measured using a modified Cleveland Clinic Incontinence Score as the primary criteria by which success is evaluated.

Official Title
-----------------
Phase 2 IDE Study of Durasphere FI in the Treatment of Fecal Incontinence

Conditions
-----------------
Fecal Incontinence

Intervention / Treatment
-----------------
* Device: Durasphere FI
* Device: Sham


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of fecal incontinence; Incontinence episodes over a 14-day period; Eighteen years of age or older; Exclusion Criteria: Abnormalities of the external sphincter greater than 10 mm; Fibrosis of the tissue at the likely injection sites; Has a condition that could lead to significant postoperative complications Rectal varices; Cancer of the rectum or colon, undergoing active treatment; Crohn's disease or ulcerative colitis; Chronic diarrhea unmanageable by drugs and/or diet; Rectal bleeding; Pregnant or within one year postpartum.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Durasphere<br> | Device: Durasphere FI<br>* Durasphere Injection<br>|
| Sham Comparator: Sham<br> | Device: Sham<br>* Sham injection with anesthesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The frequency and severity of fecal incontinence symptoms will be measured using a modified Cleveland Clinic Incontinence Score |  | 6 month | 
| Safety will be demonstrated through an analysis of morbidity and complication rates associated with Durasphere. |  | Throughout study | 
| The proportion of patients maintaining a 25% improvement in Cleveland Clinic Incontinence Score |  | 12 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fecal Incontinence
Dupixent and Narrowband UVB for Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
24 weeks open-label study with dupilumab and narrowband UVB phototherapy three times weekly for 12 weeks followed by 12 weeks of dupilumab monotherapy.

Detailed Description
-----------------
24 weeks open-label study with dupilumab and narrowband UVB phototherapy three times weekly for 12 weeks followed by 12 weeks of dupilumab monotherapy.

Official Title
-----------------
Single Center, Pilot Study to Evaluate the Effectiveness and Safety of Dupilumab in Combination With Narrowband UVB (nUVB) Phototherapy in the Treatment of Moderate-to-Severe Atopic Dermatitis

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Drug: Dupixent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female adult ≥ 18 years of age; Diagnosis of moderate to severe atopic dermatitis as defined at baseline by: EASI score of 16 or greater, IGA score of 3 or greater BSA of 10% or greater, Exclusion Criteria: Subjects with previous exposure to dupilumab. Known or suspected hypersensitivity to dupilumab or any of its excipients. History of photosensitivity.

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: Dupixent and Narrowband UVB<br>Dupixent and Narrowband UVB | Drug: Dupixent<br>* dupilumab 300mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigators Global Assessment Score of score of 0 or 1 | Proportion of subjects achieving an IGA score of 0 or 1 with at least a 2 grade improvement at week 12 | 12 weeks |
A Study to Evaluate THR-317 Treatment for Macular Telangiectasia Type 1 (MacTel 1)

Study Overview
=================
Brief Summary
-----------------
This study is conducted to evaluate the safety of THR-317 when administered intravitreally and to assess the compound's efficacy in reducing central subfield thickness (CST) and improving best-corrected visual acuity (BCVA) in subjects with macular telangiectasia Type 1 (MacTel 1).

Official Title
-----------------
A Phase 2, Open-label, Multi-centre Study to Assess the Efficacy and Safety of Intravitreal THR-317 for the Treatment of Macular Telangiectasia Type 1 (MacTel 1)

Conditions
-----------------
Retinal Telangiectasis, Idiopathic Juxtafoveal Retinal Telangiectasia

Intervention / Treatment
-----------------
* Drug: THR-317 8mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 18 years or older Macular oedema caused by MacTel 1, with CST >300µm on SD-OCT Written informed consent obtained from the subject prior to screening procedures Exclusion Criteria: Type 1 or type 2 Diabetes Mellitus Concurrent disease in the study eye that could require medical or surgical intervention during the study period for up to 30 days after the last study treatment, or could confound interpretation of the results Previous confounding treatments / procedures, or their planned / expected use during the study period for up to 30 days after the last administration of study treatment Any active ocular / intraocular infection or inflammation in either eye Pregnant or lactating female, or female of child-bearing potential not utilising an adequate form of contraception, or male of reproductive potential not utilising contraception

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: THR-317<br> | Drug: THR-317 8mg<br>* 3 intravitreal injections of THR-317 8mg, approximately 1 month apart<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in central subfield thickness (CST), based on spectral domain optical coherence tomography (SD-OCT) |  | At Day 84 (Month 3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in CST, based on SD-OCT, by study visit |  | From baseline to Day 140 | 
| Change from baseline in area of cystoid spaces, based on SD-OCT, by study visit |  | From baseline to Day 140 | 
| Change from baseline in best-corrected visual acuity (BCVA), by study visit |  | From Day 0 to Day 140 | 
| Incidence of systemic and ocular adverse events including serious adverse events |  | From Day 0 to Day 140 |