linjc16/ctgov huggingface dataset:
Goal-orientated Therapy of Perioperative Disturbance in Hemostasis in Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Aim of this study is to investigate whether patients preoperatively treated with acetylsalicylic acid and/or clopidogrel have fewer perioperative bleeding and lower amounts of blood substitution when managed by ROTEM (whole blood coagulation analyzer) and MULTIPLATE (thrombocyte function analyzer).

Official Title
-----------------
Goal-orientated Therapy of Perioperative Disturbance in Hemostasis With MULTIPLATE and ROTEM in Cardiac Surgery Patients Under Platelets Inhibitors

Conditions
-----------------
Coronary Artery Bypass Graft Triple Vessel, Blood Coagulation Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: written consent Exclusion Criteria: no written 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 |
| --- | --- |
| Point-of-Care managed<br>This arm includes all patients in which the hemostatic therapy is guided by POC devices e.g. MULTIPLATE (a platelet function analyzer) or ROTEM (thromboelastometry) | |
| Conventional hemostasis lab managed<br>This arm includes all patients in which the hemostatic therapy is guided by conventional hemostasis laboratory data e.g. INR, aPTT, fibrinogen concentration, platelet count but no POC devices e.g. MULTIPLATE (a platelet function analyzer) or ROTEM (thromboelastometry) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative blood loss |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perioperative substitution with erythrocyte concentrates, thrombocyte concentrates or fresh frozen plasma |  | 24 hours and 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hemostasis monitoring, perioperative blood loss
IUI vs. IVF/ICSI in Women Aged 38-42 Years: a Prospective Randomized Controlled Trial.

Study Overview
=================
Brief Summary
-----------------
Prospective randomised controlled trial: 3 IUI cycles versus 1 IVF/ICSI cycle in women aged 38-42 years.

Detailed Description
-----------------
Study design: Prospective randomised controlled trial: 3 IUI cycles versus 1 IVF/ICSI cycle in women aged 38-42 years. . Group 1: 3 consecutive gonadotrophin stimulated IUI cycles (Follitropine Bèta, Puregon, MSD). vs. Group 2: 1 IVF/ ICSI cycle - Recombinant FSH (Follitropine Bèta, Puregon, MSD) - Antagonist protocol.

Official Title
-----------------
IUI vs. IVF/ICSI in Women Aged 38-42 Years: a Prospective Randomized Controlled Trial

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Other: Drug: Follitropine Bèta


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged between 38 and 42 years. Sperm: use of donor sperm or husband sperm reaching WHO criteria 2010. Exclusion Criteria: Tubal infertility (even one tube). Major uterine or ovarian abnormalities Metabolic abnormalities

Ages Eligible for Study
-----------------
Minimum Age: 38 Years
Maximum Age: 42 Years

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IUI group<br>Group 1: Patients undergo a standard treatment with 3 consecutive gonadotrophin stimulated IUI cycles Intervention: treatment choice and drug:(Follitropine Bèta, Puregon, MSD). vs. | Other: Drug: Follitropine Bèta<br> <br> |
| Active Comparator: IVF/ICSI arm<br>Group 2: 1 Patients start immediately with IVF/ICSI instead of IUI. A standard antagonist protocol with treatment with a recombinant FSH (Follitropine Bèta, Puregon, MSD) is used. Intervention: treatment choice and drug: recombinant FSH (Follitropine Bèta, Puregon, | Other: Drug: Follitropine Bèta<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy rate | Study design: Prospective randomised controlled trial: 3 IUI cycles versus 1 IVF/ICSI cycle in women aged 38-42 years. Group 1: 3 consecutive gonadotrophin stimulated IUI cycles (Follitropine Bèta, Puregon, MSD). vs. Group 2: 1 IVF/ ICSI cycle - Recombinant FSH (Follitropine Bèta, Puregon, MSD) - Antagonist protocol. Primary endpoint: Comparison of the cumulative ongoing pregnancy rates after 3 IUI cycles versus 1 IVF/ICSI cycle. | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Age (38-42 years), pregnancy rates, 3 IUI cycles, 1 IVF/ICSI cycle
Real Time Optical Coherence Tomography (OCT) of Human Tissue

Study Overview
=================
Brief Summary
-----------------
This is a single-arm, prospective, study of an optical imaging device on approximately twenty (20) subjects undergoing lumpectomies at one study site. In vivo and ex vivo imaging will be performed on study subjects with results being compared to final pathology.

Detailed Description
-----------------
This study is a single-center, prospective, two-part open label study of an optical imaging device on approximately twenty (20) subjects at one (1) study site. Patients scheduled to undergo a lumpectomy will be recruited by the clinical investigators at the investigational site in accordance with the inclusion and exclusion criteria. The study period per subject is the time it takes to assess the in vivo and ex vivo breast tissue samples using the study device during their lumpectomy. All specimens will be marked with India ink and undergo standard post-operative histology, and digital histology images corresponding to the inked locations will be obtained. The images and the matched digitized post-operative histology images will then be randomized and read by a blinded, independent pathologist. Sensitivity and specificity will be calculated.

Official Title
-----------------
Real Time Optical Coherence Tomography (OCT) of Human Tissue

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Device: Optical Coherence Tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women 18 years of age or older Signed ICF Women who have been histologically diagnosed with invasive ductal carcinoma or invasive lobular carcinoma of the breast prior to surgery Planning breast preservation Patients undergoing lumpectomy (partial mastectomy) procedure Exclusion Criteria: Multicentric disease (histologically diagnosed cancer in two different quadrants of the breast) Neoadjuvant systemic therapy All T4 tumors Previous radiation in the operated breast Prior surgical procedure in the same quadrant Implants in the operated breast Pregnancy Lactation Participating in any other investigational study for either drug or device which can influence collection of valid data under this study

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Optical Coherence Tomography|Optical coherence tomography will be used to image tissue structure on excised and in vivo specimens.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sensitivity and specificity of Optical Coherence Tomography to identify whether or not tumor can be identified ex vivo on breast cancer specimens as compared to post-surgical histology conclusions. |  | One week after surgery |
Neurobiology of Posttraumatic Stress Disorder Dysfunction and Recovery Following Cognitive Processing Therapy

Study Overview
=================
Brief Summary
-----------------
Posttraumatic stress disorder (PTSD) is a significant personal and societal burden. The purpose of this study is to examine genetic, epigenetic, behavioral, and brain activity changes related to PTSD dysfunction and recovery before and after treatment with Cognitive Processing Therapy.

Detailed Description
-----------------
Using functional magnetic resonance imaging approaches, the present research aims to examine the relationship between traumatic experience and the neural mechanisms of various PTSD symptoms, and determine how this relationship changes during PTSD extinction. Also, this proposal aims to better understand how the genetic/epigenetic profile of several genes predicts, and perhaps changes, in response to recovery from PTSD along with its neural correlates. This understanding will help identify individuals who will respond most optimally to a specific empirically based PTSD treatment, Cognitive Processing Therapy, while further connecting genetic biomarkers of risk with neural intermediate phenotypes underlying PTSD symptomatology.This study is observational as the investigator does not assign specific interventions to the participants of the study.

Official Title
-----------------
Neurobiology of Posttraumatic Stress Disorder Dysfunction and Recovery Following Cognitive Processing Therapy

Conditions
-----------------
Posttraumatic Stress Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PTSD diagnosis, as measured by the Clinician Administered PTSD Scale for DSM-5 history of chronic childhood trauma due to relational abuse Ability to understand and sign informed consent Enrollment in CPT program at McLean Hospital Both genders, all ethnic backgrounds, age between 18 and 55 Fluent English speakers Normal or Corrected Vision Exclusion Criteria: History or current schizophrenia spectrum disorder or other psychotic disorders History or current bipolar or other related disorders Alcohol and/or substance use disorder within the past month Metal implants Medical or neurological illness (e.g., seizures, head injury in which they experienced a loss of consciousness) Positive pregnancy test

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Potential Change in Evidence of PTSD symptoms with neuroimaging |  | Within 30 days before and again within 30 days after Cognitive Processing Therapy Treatment. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PTSD, biomarker, Cognitive Processing Therapy
Analysis of a New Biomarker for Prostate Cancer Diagnosis

Study Overview
=================
Brief Summary
-----------------
The aim of our study is to determine if the levels of the HEM substance in seminal plasma are associated with the presence of prostate cancer in transrectal prostate biopsy.

Conditions
-----------------
Patients With Suspected Prostate Cancer

Intervention / Treatment
-----------------
* Other: determine the levels of the HEM substance in seminal plasma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical or laboratory suspected of prostate cancer Exclusion Criteria: Inability to ejaculate

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with suspected prostate cancer<br> | Other: determine the levels of the HEM substance in seminal plasma<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| substance HEM concentration in seminal plasma (mEq/L measured by spectro-photometry |  | 1 hour |
Clinical Safety Trial of Long-Term Intermittent Use of Helioblock® SX Cream

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety potential of Helioblock® SX Cream as a sunscreen product in long term intermittent use conditions among pediatric subjects.. Each subject will be enrolled to participate for six months. The test product should be applied every day that outdoor activities are planned, prior to any significant sun exposure during out-door activities (such as the beach, outdoor sport activities), or whenever the subject needs to be protected against sunburn or other damage due to the sun. A minimum of 14 days test product use and sun exposure is required.

Conditions
-----------------
Sunburn

Intervention / Treatment
-----------------
* Drug: Helioblock® SX Cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects of any race or skin type, 6 months to 12 years of age inclusive, willing to use the test product intermittently for six months during outside activities Exclusion Criteria: Subjects with known sensitivities to any of the study ingredients or subjects with a condition or in a situation, which in the Investigator's opinion, may suggest a significant hazard for the subject, may confound the study results, or interfere with the subject's participation in the study. Subjects who are pregnant or lactating

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 12 Years

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Helioblock® SX Cream|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term safety after 6 months intermittent use in a pediatric population |  | 6 months |
Changes of Oxygen Saturation in Inferior Vena Cava (IVC) in Patients During and After High Risk Abdominal Surgery and Relationship to the Outcome

Study Overview
=================
Brief Summary
-----------------
Tissue hypoxia is one of the most important factors leading to the development of multiorgan failure. Patients presenting for emergent major abdominal surgery might suffer from organ hypoperfusion. Thus, early detection of the imbalance between oxygen supply and demand may improve the outcome. The investigators believe that hypoperfusion of the abdominal organs will cause a decrease of the saturation in the hepatic vein and in the IVC.

Official Title
-----------------
Changes of Oxygen Saturation in Inferior Vena Cava (IVC) in Patients During and After High Risk Abdominal Surgery and Relationship to the Outcome.

Conditions
-----------------
Abdominal Surgery

Intervention / Treatment
-----------------
* Device: Central vein catheterization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All consecutive patients presenting for emergency surgery due to acute abdomen pain Older than 18 years old Not pregnant Exclusion Criteria: Age < 18 Pregnancy Major coagulopathy Permanent pacemaker

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 |
| --- | --- |
| Patients before emergent major abdominal surgery<br> | Device: Central vein catheterization<br>* Blood samplings from IVC catheter<br>|

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
-----------------
central venous oxygen saturation, oxygen transport, physiologic monitoring, tissue oxygenation, Patients before high risk abdominal surgery
Symptomatic Efficacy of Diacerein in Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
Pain is the main symptom of osteoarthritis that motivates medical visits. Diacerhein has already demonstrated its efficacy in knee and/or hip osteoarthritis. This study aims at confirming the efficacy of diacerhein in symptomatic knee osteoarthritis using known and validated criteria and according to the recommendations and guidelines for this kind of study.

Official Title
-----------------
Efficacy Study of Diacerein in the Symptomatic Treatment of Knee Osteoarthritis

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Drug: Diacerein


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Painful primary osteoarthritis (VAS ≥ 40 mm) Radiologically proven (Kellgren & Lawrence grade I to III) Requiring the prescription of a symptomatic treatment of pain Exclusion Criteria: Severe associated diseases Wash-out: AINS, Coxibs, Paracetamol, anti-osteoarthritic treatments, hyaluronic acid, knee tidal lavage Other osteoarticular 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS on pain movement, WOMAC A 1.1 section |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC : total, pain, physical function |  |  | 
| Paracetamol consumption |  |  | 
| Global assessment of the patient |  |  | 
| Responder patients with OMERACT-OARSI criteria |  |  | 
| Tolerance |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, Knee, Diacerein, Painful osteoarthritis, Clinical trial
Impact of Intraduodenal Acetic Acid Infusion on Pancreatic Duct Cannulation During Endoscopic Retrograde Cholangiopancreatography: a Double-blind, Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
Intraduodenal acetic acid can stimulate secretion of water and bicarbonate from pancreatic ductal cells. In this study, acetic acid spraying to duodenal bulb was compared with saline solution for the facilitation of pancreatic duct cannulation in patients.The primary outcome was successful deep pancreatic duct cannulation. The secondary outcomes were the appearance of the major and minor papillary orifice, pancreatic juice flow from the papilla, time to achieve deep pancreatic duct cannulation, and fluoroscopy time for deep pancreatic duct cannulation in the acetic acid group versus saline group.

Conditions
-----------------
Pancreatic Duct Cannulation During Endoscopic Retrograde Choledochopancreatography

Intervention / Treatment
-----------------
* Dietary Supplement: acetic acid
* Dietary Supplement: saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion criteria were(1)those with intact native papilla (2)who underwent endoscopic retrograde choledochopancreatography for pancreatic duct, (3)age≥18 years，≦80years,and (4)agreement to participate in the study. Exclusion Criteria: Exclusion criteria were (1) a previous sphincterotomy, (2) previous attempted or unsuccessful endoscopic retrograde choledochopancreatography with papillary manipulation, (3) indwelling biliary or pancreatic stent(s), (4) active acute pancreatitis, (5) altered/postsurgical anatomy, (6) history of gastroparesis, and (7) endoscopic retrograde choledochopancreatography for sphincter of Oddi (SO) manometry.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: acetic acid<br>spray 50ml acetic acid to duodenal bulb | Dietary Supplement: acetic acid<br> <br> |
| Placebo Comparator: saline<br>spray 50ml saline to duodenal bulb | Dietary Supplement: saline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cannulation time for deep pancreatic duct cannulation |  | 2 days | 
| fluoroscopy time for deep pancreatic duct cannulation |  | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pancreatic juice flow from the major papilla |  | 2 days | 
| appearance of the major papillary orifice |  | 2 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pancreatic duct, ERCP, acetic acid