linjc16/ctgov huggingface dataset:
Effects of Antidepressants on Sexual Functioning

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to study the effects of two depression medications on sexual functioning.

Official Title
-----------------
A Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Effects on Sexual Functioning of Extended-Release Bupropion Hydrochloride (300-450mg) and Escitalopram (10-20mg) in Outpatients With Moderate to Severe Major Depression Over an Eight-Week Treatment Period

Conditions
-----------------
Major Depressive Disorder (MDD)

Intervention / Treatment
-----------------
* Drug: Extended-Release Bupropion Hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary diagnosis of Major Depressive Disorder (MDD) with current duration lasting 12 weeks but no greater than 2 years. Subjects must engage in sexual activity that leads to orgasm at least once every two weeks. Subject must have normal orgasmic function and be willing to discuss with investigator. Exclusion Criteria: Subjects that have arousal or orgasm dysfunction. Has previously failed to respond to two adequate trials of antidepressants in past 2 years. Subject has other unstable medical disorders. Subject has a positive urine test for illicit drug use at screening.

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Extended-Release Bupropion Hydrochloride|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with orgasm dysfunction. Change in HAMD-17 total score. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of subjects in remission, HAMD-17. Changes in Sexual Functioning Questionnaire. Percent of responders, HAMD-17 CGI-I and CGI-S. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MDD, depression, sexual dysfunction, orgasm disorder
Role of the Interaction Between Advanced Glycation End Products and Their Receptor RAGE in the Development and the Progression of the Uremic Vasculopathy of Hemodialyzed Patients

Study Overview
=================
Brief Summary
-----------------
Chronic kidney disease (CKD) is associated with an extensive vasculopathy and high cardiovascular mortality as well as an accumulation of uremic toxins. Among the latest, advanced glycation end-products (AGEs) interact with RAGE. Investigators aimed to analyze the role of RAGE in the calcification process of hemodialyzed patients, in a correlative and prospective study. Vascular calcifications will be assessed by Xray and tomodentimetry while accumulation of AGEs will be measured in the serum and in the skin (non invasive). Additionally factors influencing RAGE activation such as genetic polymorphism and level of soluble forms of RAGE will be measured and analyzed.

Official Title
-----------------
Role of the Interaction Between AGEs and Their Receptor RAGE in the Development and the Progression of the Uremic Vasculopathy of Hemodialyzed Patients

Conditions
-----------------
Hemodialyzed Patients

Intervention / Treatment
-----------------
* Other: Vascular calcifications by Xray
* Other: Vascular calcifications by tomodentimetry
* Biological: Blood sample withdrawn


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Renal impairment Hemodialysis for more than 3 months Have agreed to participate in research Affiliated to a social security scheme major Exclusion Criteria: Diabetes , for diabetes induces accelerated formation of advanced glycation end products , which could then be a confounding factor in our study. Protected by law . minors pregnant women Matt or pigmented skin because the skin hyperpigmentation interfere with reading the skin fluorescence giving falsely elevated values . Having an aneurysm of the abdominal aorta known Suffering from a progressive neoplastic disease

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients<br> | Other: Vascular calcifications by Xray<br> <br> Other: Vascular calcifications by tomodentimetry<br> <br> Biological: Blood sample withdrawn<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frammingham Score |  | up to 12 months |
Fixation of Skin Grafts in Patients With Burns: Comparison Between Cyanoacrylate Glue and Skin Staples

Study Overview
=================
Brief Summary
-----------------
Skin graft fixation is essential for the success of its survival. There are several common methods for skin graft fixation including sutures, skin staples and glue. The study objective is to compare between skin graft fixation with staples and glue in burn patients. The study is retrospective. It Includes 44 patients that were hospitalized in the burn unit, Rabin Medical Center, Israel with 2nd and 3rd degree burns, total body surface area 1-50% during 1/2002-5/2003.All patients were operated for debridement and skin grafting. In 29 patients the skin graft was fixated with staples and in 15 with cyanoacrylate glue (histoacryl). The parameters that will be compared are skin graft take, hospitalization length and local infection.

Official Title
-----------------
Fixation of Skin Grafts in Patients With Burns: Comparison Between Cyanoacrylate Glue and Skin Staples

Conditions
-----------------
Grafting, Skin, Burn

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hospitalized patients with 2nd and 3rd degree burns who were operated for debridement and skin grafting burn total body surface area 1-50% Exclusion Criteria: burn total body surface area> 50%

Ages Eligible for Study
-----------------
Minimum Age: 0 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
skin graft, fixation, cyanoacrylate glue, skin staples
Examination of Potassium Levels in Saliva in ESRD Patients

Study Overview
=================
Brief Summary
-----------------
Dialysis patients typically undergo 3 treatments a week every other day with an almost 3 day gap during the weekend. After this gap and before the first dialysis of the week the serum Potassium level is expected to be maximal. Participants will be recruited from the dialysis clinic at Hadassah Ein Kerem Hospital. The research team would personally meet the patients who answer inclusion criteria f and ask whether they wish to participate. Each willing participant will undergo Sialometry and blood will be drawn from the dialysis connections for CBC and Biochemistry to establish a baseline. The study measurements namely Sialometry and collection of Saliva as well as blood test will be taken before the initiation of the dialysis. Blood testing will be done via the laboratories of the Hadassah hospital. Saliva analysis will be done in the research lab of Prof. Doron Aframian.

Official Title
-----------------
Examination of Potassium Levels in Saliva in ESRD Patients

Conditions
-----------------
ESRD

Intervention / Treatment
-----------------
* Procedure: sialometry
* Procedure: blood test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Present a predialysis serum potassium level over 5 mmol/L. Exclusion Criteria: Pregnancy Patients diagnosed with a pathology of the salivary glands such as Sjogren's syndrome, Sialosis, Sialadenitis. Patients who have received previous radiation therapy to the head and neck region

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 |
| --- | --- |
| potassium level in saliva<br>Each willing participant will undergo Sialometry | Procedure: sialometry<br>* potassium evaluation<br>|
| blood test<br>blood will be drawn from the dialysis connections for Biochemistry for potassium level evaluation | Procedure: blood test<br>* potassium evaluation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| potassium level in saliva |  | 7 days | 
| Standard Biochemistry of blood |  | 7 days |
Clinical Study in Treatment of Malignant Ascites of Ovarian Cancer With Intraperitoneal Injection Bevacizumab Combined With Intraperitoneal Hyperthermic Perfusion Chemotherapy

Study Overview
=================
Brief Summary
-----------------
To study the efficacy and safety of intraperitoneal injection bevacizumab combined with intraperitoneal hyperthermic perfusion chemotherapy in treatment of malignant ascites of ovarian cancer. To analyze the clinical significance of the concentration change of vascular endothelial growth factor (VEGF) in ascites in treatment of intraperitoneal injection bevacizumab

Conditions
-----------------
Ovarian Cancer With Malignant Ascites

Intervention / Treatment
-----------------
* Drug: Bevacizumab
* Drug: TC:paclitaxel + carboplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient's awareness and willingness to comply with the study requirements. Histologically confirmed and documented ovarian cancer with malignant ascites. ECOG(Eastern Cooperative Oncology Group, ECOG) PS 0-2. Life expectancy of >3 months. No serious inadequate bone marrow function, liver and renal function or significant cardiovascular disease. Exclusion Criteria: Known hypersensitivity to any of the study drugs or excipients. Any current anti-cancer therapy. No evidence of ascites. Key organ dysfunction. Significant cardiovascular disease (e.g. congestive heart failure (CHF), uncontrolled cardiac arrhythmia, angina, heart valve disease, myocardial infarction and refractory hypertension need to be long time controlled by medicine). Non-healing wound, ulcer or bone fracture. Uncontrolled psychiatric history.

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bevacizumab+TC<br>The treatment group were accepted intraperitoneal injection with bevacizumab (avastin) 300mg after each intraperitoneal hyperthermic perfusion chemotherapy for 6 weeks. | Drug: Bevacizumab<br> <br> Drug: TC:paclitaxel + carboplatin<br> <br> |
| Active Comparator: TC<br>patients were treated with TC chemotherapy (paclitaxel 135mg/m2 ,iv d1+ carboplatin AUC=5, iv d1), 1 time/3 weeks for 6 weeks, and with intraperitoneal hyperthermic perfusion chemotherapy combined with intraperitoneal cisplatin 40mg/m2，1 time/2 weeks for 6 weeks | Drug: TC:paclitaxel + carboplatin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective response rate |  | 24month |
Natera Ovarian Cancer Detection Assay

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to enroll participants who present with an adnexal mass on imaging to develop a non-invasive ovarian cancer assay to distinguish between malignant and benign masses. The study will collect blood, tissue, and health information from these individuals.

Official Title
-----------------
Prospective Collection of Samples for Development of the Natera Ovarian Cancer Detection Assay

Conditions
-----------------
Adnexal Mass

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presenting to clinic with adnexal mass suspicious of ovarian, fallopian tube, or peritoneal cancer on imaging Must be planning surgical resection or biopsy Must be treatment naïve Must be 18 years or older Able to understand and sign a written informed consent document Able to provide 40mL of blood (at least 20mL) for each blood draw Exclusion Criteria: Prior removal of either ovary for any reason Currently pregnant Blood transfusion within 3 months of study enrollment History of bone marrow or organ transplant Prior history and treatment for any malignancy, with exception of previously treated non-melanoma skin cancer. A medical condition that would place subject at risk as a result of the blood donation, including but not limited to bleeding disorders, chronic infectious disease, emphysema or serious anemia

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

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

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 |
| --- | --- | --- |
| Compare ctDNA from benign ovarian masses and confirmed ovarian cancers | Examine ctDNA between benign ovarian masses and confirmed ovarian cancer cases (based on tumor pathology report). The purpose of this outcome is to determine whether cfDNA could be used to develop a non-invasive ovarian cancer assay to distinguish between malignant and benign masses. | Up to 60 months or 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the relationship between quantity of ctDNA and standard prognostic criteria | Examine quantity of ctDNA and standard prognostic criteria such as tumor grade, histology and stage of cancer | Up to 60 months or 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adrexal mass, ovarian cancer, fallopian tube cancer, peritoneal cancer
Post-Marketing Study Of The Safety Of Tygacil (Tigecycline)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect post-marketing information on the safety of Tygacil in Filipino patients.

Detailed Description
-----------------
Three-thousand or 10% of total number of patients given tigecycline will be included in the study

Official Title
-----------------
A Prospective, Observational Study To Monitor Safety In Patients Who Were Administered With Tigecycline (Tygacil) 50 mg By Intravenous Injection (An Observational Study for Safety - Monitored Release)

Conditions
-----------------
Complicated Skin and Skin Structure Infections, Complicated Intra-abdominal Infections

Intervention / Treatment
-----------------
* Drug: Tigecycline (Tygacil)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients from the study center who received or will receive at least one dose of Tygacil according to the approved product indication. Exclusion Criteria: Previously discontinued Tygacil therapy due to significant safety concern.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br> | Drug: Tigecycline (Tygacil)<br>* This is a non-interventional study; patients are administered Tygacil as prescribed by their doctor as per registered indications stated in product label/insert (50 mg by Intravenous Injection).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Spontaneous Adverse Events | Adverse events were based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participant. In addition to the information obtained from these sources, the participant was asked the following nonspecific question: How have you been feeling since your last visit? | 30 days post injection up to 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Observational study, Tigecycline, infection, skin, abdominal
Long Term Results of Amniotic Membrane Transplant in Bullous Keratopathy Patients

Study Overview
=================
Brief Summary
-----------------
A retrospective study including 22 patients who have undergone amniotic membrane transplant in our unit up till 2016. Confocal microscopy and anterior segment optical coherence tomography (ASOCT) were performed to assess the retention of amniotic membrane and to detect any corneal structural changes. Comparison was made with 5 controls who had bullous keratopathy awaiting endothelial keratoplasty.

Detailed Description
-----------------
This retrospective cohort study (CREC Ref No.: CRE-2013.687) was approved by the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee. All patients who had AMT done due to symptomatic bullous keratopathy at the Prince of Wales Hospital and Alice Ho Miu Ling Nethersole Hospital (from 1998 onwards till June 2016) were invited back for confocal microscopy and anterior segment optical coherence tomography (ASOCT) at the clinic by the principal investigator (GS) from October to November 2016.

Official Title
-----------------
Amniotic Membrane Transplant in Symptomatic Bullous Keratopathy Patients: Confocal Microscopy & AS-OCT Long Term Results

Conditions
-----------------
Bullous Keratopathy

Intervention / Treatment
-----------------
* Procedure: Amniotic membrane transplant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who have undergone amniotic membrane transplant in our cluster up till 2016. Patients who have bullous keratopathy on conservative treatment such as lubricants, bandage contact lens Exclusion Criteria: patients who refuse to participate in the study, have passed away or cannot return for the clinical assessment will be excluded.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case(AMT patients)<br>patients who have undergone amniotic membrane transplant in our unit up till 2016. | Procedure: Amniotic membrane transplant<br>* Amniotic membrane graft was transplanted onto the bullous cornea by the inlay technique<br>|
| Control(Patients without AMT)<br>bullous keratopathy patients awaiting endothelial keratoplasty | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amniotic membrane retention | Amniotic membrane retention in the cornea was assessed with confocal microscopy | from date of operation till 2016 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | pain score (from 0-10, scale interval 1, 0 no pain, 10 most painful)reduction after amniotic membrane tranplant | from date of operation till 2016 |
Feeding Bottle Design, Milk Intake and Infant Growth

Study Overview
=================
Brief Summary
-----------------
It is increasingly recognised that rapid growth in infancy may be associated with a greater risk of cardiovascular disease later in life. This trial will investigate whether the use of infant feeding bottles with different designs influences the milk intake and growth of infants. We will compare the growth of bottle-fed infants with that of a breast-fed reference group.

Conditions
-----------------
Healthy Infants

Intervention / Treatment
-----------------
* Device: partial-vacuum milk bottle
* Device: anti-vacuum milk bottle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy term infants birth weight >2.50kg, gestational age >37 weeks Exclusion Criteria: -

Ages Eligible for Study
-----------------
Maximum Age: 7 Days

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: partial-vacuum milk bottle|nan|
|Device: anti-vacuum milk bottle|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |