linjc16/ctgov huggingface dataset:
Unwanted Penile Engorgement in Pediatric Patients Under Anesthesia.

Study Overview
=================
Brief Summary
-----------------
Penile engorgement during intraoperative period is of rare occurrence however when do happens, leads to difficulty in performing and even cancellation of elective urogenital surgery. The mechanism behind intraoperative penile engorgement is complex and involves various factors. One common myth is that penile engorgement occurs only during spinal anaesthesia and not in general anaesthesia. In this study we intend to report the incidence and management of intraoperative penile engorgement in pediatric patients undergoing urogenital operations under spinal anesthesia with/without sedation over a period of one year. The pathophysiology and role of common contributing factors leading to intraoperative penile engorgement are also discussed.

Official Title
-----------------
Unwanted Penile Engorgement in Pediatric Patients Under Anesthesia: A Prospective Cohort Study to Discuss the Role of Anesthetic Technique and Other Common Contributing Factors.

Conditions
-----------------
Anesthesia; Functional

Intervention / Treatment
-----------------
* Procedure: spinal anaesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologist grade1 & 2 Elective urogenital surgery of expected duration less than one hour Exclusion Criteria: patients with local infection, coagulation abnormalities, expected duration of surgery >1 hour and spinal anomalies. parents of patient not giving consent for spinal anaesthesia.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 12 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: spinal anaesthesia|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative penile engorgement | Incidence of intraoperative penile engorgement under anaesthesia | sixty minutes from start of anaesthesia | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intraoperative penile engorgement, Anaesthesia, Urogenital surgery
Epigenetics of Posttraumatic Stress Disorder and Somatoform Disorders in the Course of Psychotherapy

Study Overview
=================
Brief Summary
-----------------
This reported observational clinical study aims at identifying epigenetic markers in a sample of patients undergoing high dose inpatient psychotherapy suffering from a variety of psychiatric/psychosomatic diseases such as somatoform disorders, posttraumatic stress disorder (PTSD), depression, anxiety disorders and eating disorders. The exact epigenetic markers that will be traced are yet to define. The investigators believe that Epigenetic patterns found in the group of psychiatric patients show differences from healthy controls Different diagnosis show differences in epigenetic patterns as well Epigenetic patterns correlate to the severity of the psychosocial disorder as measured in interviews or psychometric ratings Epigenetic patterns can change under inpatient high dose psychotherapy Changes correlate to clinical psychometric variables.

Conditions
-----------------
Psychiatric Disorder, Somatoform Disorders, PTSD

Intervention / Treatment
-----------------
* Behavioral: psychotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: informed consent given by the patient adulthood to 65 years stabel physical health at least fluent in German language (as it is a group-therapy) Exclusion Criteria: psychiatric disorder such as substance addiction, psychosis, schizophrenia. insufficient understanding of the terms and conditions of the study insufficient emotional stability to fill out the psychometric forms required for the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| in- and out-patient psychotherapy patients<br>All included patients are highly selected in- and outpatients in a department of psychosomatic medicine (Germany) undergoing high dose psychotherapy (e.g. group therapy, creative therapy, cbt and psychodynamic psychotherapy). | Behavioral: psychotherapy<br>* multimodal complex psychotherapy<br>* Other names: all patients in the department are primarily included. There are no parallel groups.;|

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
-----------------
somatoform disorders, PTSD, epigenetics, psychotherapy, psychosomatics
Psychological Impairment Due to Covid-19

Study Overview
=================
Brief Summary
-----------------
Hospital staff and emergency personnel are expected to suffer impaired psychological outcomes during a pandemic in terms of Quality of Life, anxiety, depression or other outcomes. The Covid-19 pandemic is a threat for both somatic and psychological health, therefore the impact of the impairment of this event on psychological parameters has to be assessed.

Detailed Description
-----------------
Hospital staff and emergency personell are confronted with severe and life-threatening situations, therefore this group is considered to be at risk for impaired psychological health. A pandemic such as the Covid-19 endemic is suggested to severely impair the psychological state of this profession, amongst others Quality of life, anxiety, depression and other parameters. Therefore, it is crucial to assess the impact of impairment due to this global threat on the psychological health of health care providers. We therefore designed this study to evaluate baseline psychological characteristics and to re-assess those values in an interval of 60 days.

Official Title
-----------------
Psychological Impairment Due to Covid-19 in Hospital Staff

Conditions
-----------------
Psychological Distress, Quality of Life

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospital staff (doctors and nurses) Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Health care providers/hospital staff<br>The targeted group are doctors and nurses (hospital stuff) of a large university hospital directly confronted with patients with Cov-19 | Other: No intervention<br>* No intervention, just of questionnaire including validated tests<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCL5 Questionnaire | Validated 20-items questionnaire for PTSD | 14 days | 
| BSI - Brief symptom inventory | The Brief Symptom Inventory (BSI) is a 53-item screener for mental health problems with 9 subscales. | 14 days | 
| PHQD | Instrument for psychological diagnostics, able to test the severity of mental disorders and the success of their treatment | 14 days | 
| WHO - QoL BREF | Qol Questionnaire, assessed QoL with respect to the individual's perceptions in the context of culture and value systems. | 14 days | 
| STAXI | The State-Trait Anger Expression Inventory is used to measure the expressions & control of anger | 14 days | 
| AUDIT questionnaire | The AUDIT questionnaire is designed to help in the self assessment of alcohol consumption | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
quality of life, psychological distress
Toffee Full Face and Toffee Nasal Mask Evaluation in Obesity Hypoventilation Syndrome (NZ)

Study Overview
=================
Brief Summary
-----------------
This investigation is to evaluate the performance, comfort and ease of use of the Toffee full face and toffee nasal mask masks amongst Obesity Hypoventilation Syndrome (OHS) patients in an overnight study.

Detailed Description
-----------------
Up to 20 OHS patients who currently use a full face mask or a nasal mask will be recruited. They will be issued a F&P Toffee Full face (if they are existing full face users) or F&P Toffee Nasal (if they are existing nasal users) for an overnight polysomnography.

Official Title
-----------------
Toffee Full Face and Toffee Nasal Mask Evaluation in Obesity Hypoventilation Syndrome (NZ)

Conditions
-----------------
Obesity Hypoventilation Syndrome

Intervention / Treatment
-----------------
* Device: Toffee full face mask/toffee nasal mask


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18+ Diagnosed with OHS by a practicing physician Existing full face mask user or a nasal mask user Prescribed PAP therapy (Bi-Level or CPAP) Exclusion Criteria: Inability to give informed consent Pregnant or think they may be pregnant Anatomical or physiological conditions making PAP therapy inappropriate Patients requiring supplemental oxygen with their PAP device Patients who are in a coma or decreased level of consciousness Existing Toffee full face and Toffee nasal mask users No arterial PCO2 value from their medical records

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: Full face/Nasal masks<br>Toffee Full face/Toffee nasal | Device: Toffee full face mask/toffee nasal mask<br>* Toffee full face mask/toffee nasal mask<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Leak data | Obtained from the participant's device and polysomnography (PSG) | 1 night | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective measurement of Leak | Questionnaire | 1 night | 
| Comfort | Questionnaire | 1 night | 
| Ease of use | Questionnaire | 1 night | 
| Sleep efficiency | Obtained through the PSG | 1 night | 
| Wake after Sleep Onset (WASO) | Obtained through the PSG | 1 night | 
| Arousal Index (AI) | Obtained through the PSG | 1 night |
Impact of the BETACONNECT Auto-injector on BETASERON Therapy Adherence and Patient Satisfaction

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess adherence and persistence to BETASERON therapy in patients who are using the BETACONNECT auto-injector device (BETACONNECT device). The secondary objective of this study is to assess patient-reported satisfaction with the BETACONNECT device.

Official Title
-----------------
Impact of the BETACONNECT Auto-injector on BETASERON Therapy Adherence and Patient Satisfaction

Conditions
-----------------
Multiple Sclerosis, Relapsing-Remitting

Intervention / Treatment
-----------------
* Drug: Interferon beta-1b (Betaseron, BAY86-5046)
* Device: BETACONNECT device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and females greater than or equal to 18 years of age Diagnosis of RRMS according to revised McDonald Criteria (2010) or (CIS) Prescribed BETASERON (note: decision to treat with BETASERON must be made independent of participation in this study) Confirmation of insurance coverage for BETASERON treatment Access to a personal computer to complete online patient satisfaction survey at Week 6 Exclusion Criteria: Currently enrolled in a clinical trial or other observational study for Multiple Sclerosis treatment Documented substance abuse within the previous 6 months prior to study enrollment Any major laboratory value abnormality that the investigator believes would preclude the patient from participating in the study Any medical disorder, condition or history that in the opinion of the investigator would impair the patient's ability to participate in or complete the study Pregnant or nursing

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 |
| --- | --- |
| Interferon beta-1b<br>Patients diagnosed with relapse-remitting multiple sclerosis (RRMS) or clinically isolated syndrome (CIS) who are injecting Betaseron via the Betaconnect device. | Drug: Interferon beta-1b (Betaseron, BAY86-5046)<br>* Applied via the BETACONNECT device. Dose as prescribed by physician.<br>Device: BETACONNECT device<br>* Used to apply Betaseron.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of BETASERON injections as captured by the BETACONNECT device |  | At 6 months | 
| Time (days) between BETASERON injections as captured by BETACONNECT device |  | At 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported satisfaction by a questionnaire |  | At 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adherence, Persistence, Patient satisfaction
Von Willebrand Factor and Protein C Ratio in Graft Function After Liver Transplant

Study Overview
=================
Brief Summary
-----------------
In liver cirrhosis (LC),the activity of von Willebrand factor (vWF)-cleaving enzyme ADAMTS13 is reduced in LC patients and consequent progression of liver injury. Remarkably, it has been reported that a severe vWF/ADAMTS13 imbalance develops during liver transplantation (LT) and persists even after LT. Such changes are thought to contribute to postoperative thrombotic complications, which may lead to early adverse events of thrombotic microangiopathy after living-donor LT (LDLT). We investigated whether vWFPCR could predict EAD or graft failure following LT and compared it with FVIIIPCR, procoagulant, such as vWF and FVIII and anticoagulant, such as PC.

Official Title
-----------------
Von Willebrand Factor and Protein c Ratio-related Thrombogenicity With Systemic Inflammation is Predictive of Graft Dysfunction After Liver Transplantation: Retrospective Cohort Study

Conditions
-----------------
Liver Transplant; Complications

Intervention / Treatment
-----------------
* Procedure: LT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who underwent LT Exclusion Criteria: deceased-donor liver transplant, and insufficient data, ABO-incompatible LT

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 |
| --- | --- |
| Low ratio<br>Liver recipient with low preoperative von Willbrand factor-to-protein C ratio | Procedure: LT<br>* Liver transplantation<br>|
| High ratio<br>Liver recipient with high preoperative von Willbrand factor-to-protein C ratio | Procedure: LT<br>* Liver transplantation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early allograft dysfunction | Immediate liver graft function | within 7 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft failure | re-liver transplantation or death, whichever was first | 90 days | 
| intensive care unit stay | days of intensive care unit stay after liver transplant | until the day of patients moving to general wards, through study completion, an average of 1 year |
Barbershop Talk: HIV Prevention for African American Heterosexual Men

Study Overview
=================
Brief Summary
-----------------
This program utilizes a community-engaged research approach to implementing and evaluating a program that seeks to reduce sexual risk behavior among Black adult heterosexual men. The investigators aims are to assess the impact of this linguistically and culturally tailored HIV prevention program on the sexual risk of heterosexual, African American men aged 18 and older, to assess the intervention's impact on the more proximal social and psychosocial variables that the program is designed to change, and to identify key contextual level factors that may impact the intervention's impact across segments of this priority population.

Official Title
-----------------
Barbershop Talk: HIV Prevention for African American Heterosexual Men

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

Intervention / Treatment
-----------------
* Behavioral: BTWB intervention
* Behavioral: Cancer prevention and screening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unprotected sex in the past three months Identify as Black or African American Exclusion Criteria: Having been in an HIV prevention research study in the last six months Reporting a history in the past five years of injection drug use Reporting a history in the past five years of having sex with other men Reporting an HIV-positive serostatus Inability to understand spoken English.

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

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BTWB intervention<br>Barbershops are assigned to either experimental or active control condition. Men recruited from experimental barbershops receive a single-session group intervention focused on HIV prevention. | Behavioral: BTWB intervention<br>* Men work in groups to complete a intervention that takes approximately two hours to complete.<br>|
| Active Comparator: Cancer prevention and screening<br>Barbershops are assigned to either experimental or control condition. Men recruited from control barbershops receive information on cancer prevention and control. | Behavioral: Cancer prevention and screening<br>* Men are provided health education about cancer screening and prevention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual Behavior | Self-reported sexual behavior is the number of participants that report any unprotected anal and/or vaginal sex in the past ninety days. | Six month follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, prevention, men, African American
Open-label Study of Nelotanserin in Lewy Body Dementia With Visual Hallucinations or REM Sleep Behavior Disorder

Study Overview
=================
Brief Summary
-----------------
This study seeks to evaluate the long-term safety and effectiveness of nelotanserin for the treatment of visual hallucinations (VHs) and Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD) in subjects with Lewy body dementia (LBD).

Detailed Description
-----------------
This is a multi-center open-label, long-term study in LBD subjects with RBD and/or VHs. Eligible subjects who completed a previous nelotanserin VH or RBD study and choose to participate in this open-label study will receive 20, 40, 60, or 80 mg nelotanserin once daily for 24 weeks.

Official Title
-----------------
An Open-label Study of Nelotanserin in Patients With Lewy Body Dementia Who Have Frequent Visual Hallucinations or REM Sleep Behavior Disorder

Conditions
-----------------
Lewy Body Dementia, Dementia With Lewy Bodies, Parkinson's Disease Dementia, Visual Hallucinations, REM Sleep Behavior Disorder

Intervention / Treatment
-----------------
* Drug: Nelotanserin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with LBD who completed a previous nelotanserin VH or RBD study Exclusion Criteria: Subjects with a current serious and/or unstable cardiovascular, respiratory, thyroid, gastrointestinal, renal, hematologic or other medical disorder

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Nelotanserin<br>Once Daily, Oral, at 20, 40, 60, or 80 mg dose | Drug: Nelotanserin<br>* Once Daily, Oral, at 20, 40, 60, or 80 mg dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term safety and tolerability will be evaluated based on incidence of adverse events (AEs) and significant changes in physical examinations, vital signs, ECGs, and clinical laboratory assessments over time during treatment. |  | 24 weeks | 
| Long-term effectiveness will be evaluated based on change in the frequency and severity of visual hallucinations (as recorded by patient's caregiver) and/or REM sleep behaviors (based on a clinical evaluator) over time during treatment. |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lewy body dementia, Dementia with Lewy bodies, Parkinson's disease dementia, Visual hallucinations, REM sleep behavior disorder