linjc16/ctgov huggingface dataset:
Vaginal and Rectal Clostridial Carriage Among Women of Reproductive Age in the United States

Study Overview
=================
Brief Summary
-----------------
This primary goals of this study are to: estimate the prevalence of Clostridium sordellii and Clostridium perfringens carriage in the rectum and/or vagina among women of reproductive age; estimate duration of carriage of the two clostridium species; and estimate the incidence of carriage at 2 weeks after a negative test.

Detailed Description
-----------------
Since 2000, clostridial pelvic infections have claimed the lives of at least 17 young, previously healthy women. The majority of infections detected by molecular methods were among women testing positive for Clostridium sordellii only; in 5 cases, deaths were due to Clostridium perfringens only; and in 3 cases, the women were positive for both. These deaths occurred among both non-pregnant and recently pregnant women. Clostridium has been isolated from the vagina in 4-18% of normal, health non-pregnant women, with Clostridium perfringens the most common isolate. Most studies do not differentiate the small percentage of other clostridia present in the vaginal microenvironment. The vaginal carriage rate for Clostridium sordellii remains unknown, but is probably very low, less than 1%. The correlates of clostridial carriage are unknown, and data on the etiology and lethality of clostridial infection among women of reproductive age are insufficient to guide possible courses of safe and effective prevention. In women infected with strains of Clostridium perfringens and Clostridium sordellii that produce the lethal toxin, it is not clear whether there is an effective treatment.

Official Title
-----------------
Vaginal and Rectal Clostridial Carriage Among Women of Reproductive Age in the United States

Conditions
-----------------
Clostridium Sordellii, Clostridium Perfringens

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing and able to provide informed consent Between ages 18 and 45 Exclusion Criteria: -Seeking emergency or oncological care

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of C sordellii or C perfringens carriage in the rectum/vagina |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of carriage of C sordellii or C perfringens |  | 2 years | 
| Incidence of C. sordelli or C. perfringens carriage at 2 weeks after a negative test |  | 2 years |
Extramedullary Acute Myeloid Leukemia (eAML): Retrospective Single Center Cohort Study, Clinicopathological, Molecular Analysis and Survival Outcomes

Study Overview
=================
Brief Summary
-----------------
Patients with extramedullary leukemia were identified over 10 years (January 2003 to September 2019). Clinicopathological,genetic-molecular features were identified and survival outcomes were studied and analyzed.

Detailed Description
-----------------
We retrospectively collected patients demographics ,including clinicopathological and genetic-molecular parameters in patients with extramedullary leukemia between January 2003 till September 2019 from King Hussein cancer center(KHCC) electronic medical records. All potential prognostic factors were identified and compared with worldwide data published previously. Treatment and survival outcomes were studies and analyzed. Primary endpoint : Overall survival (OS). Secondary endpoint : Progression Free Survival (PFS). incidence of extramedullary leukemia.

Official Title
-----------------
Extramedullary Acute Myeloid Leukemia (eAML): Retrospective Single Center Cohort Study, Clinicopathological, Molecular Analysis and Survival Outcomes

Conditions
-----------------
Acute Myeloid Leukemia

Intervention / Treatment
-----------------
* Other: retrospective data analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult subjects aged ≥18 year and up to 75 years Male and females. Initially diagnosed and treated with extramedullary leukemia at KHCC and followed till last encounter. Patients, who underwent an allogeneic stem cell transplant. Period January 2003-September 2019 Exclusion Criteria: Pediatric patients <18 year of age Patients, who lost their follow up within study period.

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 with extramedullary leukemia(eAML) with myeloid neoplasms<br> | Other: retrospective data analysis<br>* chart review, analysis and reporting outcomes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS), | To calculate the median and estimated 4-year overall survival | 4 year, year 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival | To calculate the median and estimated 4-year PFS | 4 year, year 4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AML, leukemia,, myeloid sarcoma, extramedullary disease
Post Covid Syndrome: Clinical Pattern and Functional Assessment

Study Overview
=================
Brief Summary
-----------------
Aim(s) of the Research : Identify post covid symptoms prevalance of post covid syndrome among survivours

Detailed Description
-----------------
There is currently very limited information on the nature and prevalence of post-COVID-19 symptoms after hospital discharge. On 11th March 2020, corona virus disease 2019 (COVID-19) was declared a global pandemic by the World Health Organisation (WHO). Egypt has been one of the worst affected countries with over 101,500 confirmed cases and more than 5,696 confirmed deaths at the time of writing (17/9 2020) .1 COVID-19 is caused by the corona virus SARSCoV-2 and presents with a wide spectrum of clinical symptoms. Wu et al reported that 81% of people with COVID-19 in China presented with mild symptoms; 14% presented with symptoms of severe respiratory dysfunction; and 5% developed a critical illness with respiratory failure, septic shock, and multiple organ dysfunction or failure.2 The medium and long-term problems experienced by survivors of COVID-19 after discharge from hospital are currently unknown, but there is some emerging evidence. An Italian study followed-up 143 individuals 7 weeks post-discharge and found 53% reporting fatigue, 43% breathlessness and 27% joint pain.3 Post-discharge symptoms may also be predicted from the previous coronavirus outbreaks of Severe Acute Respiratory Syndrome (SARS) in 2002 and Middle East Respiratory Syndrome (MERS) in 2012. A meta-analysis of 28 follow-up studies found that one quarter of hospitalised survivors of SARS and MERS had reduced lung function and exercise capacity at six months post-discharge.4 At one year, post-traumatic stress disorder (PTSD), depression and anxiety, and reduced quality of life were observed Specific data concerning the rehabilitation needs of this group is therefore urgently required.

Official Title
-----------------
Post Covid Syndrome: Clinical Pattern and Functional Assessment

Conditions
-----------------
Covid19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients diagnosed as covid 19 with chest ct and/or nasopharyngeal swab for covid 19 age 18 years old and above post covid syndrome after 6 weeks Exclusion Criteria: 1-below age of 18 2 -not confirmed cases 3. symptoms less than 6 weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify post covid symptoms | by interview questionnaire | after 4 weeks of diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalance of post covid syndrome among survivours | by interview questionnaire | after 4 weeks of diagnosis |
Transversus Abdominus Plane Catheters for Open Inguinal Hernia Repair

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate pain control of continuous transversus abdominis plane (TAP) blocks placed for open inguinal hernia repair. The investigators hypothesize that there will be improved pain control when compared with sham blocks.

Detailed Description
-----------------
This study is a randomized, controlled trial designed to determine whether continuous transversus abdominis plane (TAP) block versus sham block has a substantial impact on pain following open inguinal hernia repair. Our primary outcome is to determine whether there will be a difference in opioid consumption within the first two days following surgery. Secondary outcomes will include: pain scores and activity assessment score.

Official Title
-----------------
Continuous Transversus Abdominus Plane Block for Open Inguinal Hernia Repair

Conditions
-----------------
Post-Operative Pain

Intervention / Treatment
-----------------
* Procedure: Transversus Abdominis Plane Block
* Procedure: Sham Block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unilateral open inguinal hernia repair ASA physical status I-III >18 years old Consent to participate in the study Exclusion Criteria: Refusal to participate in the study <18 years old Chronic opioid use Localized infection Pregnancy or lactating Pre-existing coagulopathy or active anticoagulant use Allergy to ultrasound gel or local anesthetics

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Block Group<br>Continuous Transversus Abdominis Plane Catheter | Procedure: Transversus Abdominis Plane Block<br>* Continuous Nerve Block<br>|
| Sham Comparator: Sham Group<br>Continuous Sham Catheter | Procedure: Sham Block<br>* Continuous Sham Catheter<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Consumption (Intravenous Morphine Equivalents) | Total Opioid Consumption | 48 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain (Numeric Rating) | NRS Pain Scale | 30 Days | 
| Activity Assessment Score | Composite Score | 30 Days |
Study Investigating the Efficacy and Safety of a Contraceptive Patch for 13 Cycles

Study Overview
=================
Brief Summary
-----------------
This study is examining a birth control patch for 13 cycles (1 year).

Official Title
-----------------
Multicenter, Open-label, Uncontrolled Study to Investigate the Efficacy and Safety of the Transdermal Contraceptive Patch Containing 0.55 mg Ethinyl Estradiol and 2.1 mg Gestodene in a 21-day Regimen for 13 Cycles in 1650 Healthy Female Subjects

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

Intervention / Treatment
-----------------
* Drug: Gestodene/EE Patch (BAY86-5016)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Requiring contraception Normal cervical smear Maximum age for smokers is 35 History of regular cyclic menstrual periods Exclusion Criteria: Pregnancy or lactation Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic) Use of other contraceptive methods than study medication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Gestodene/EE Patch (BAY86-5016)<br>* 55 mg ethinyl estradiol & 2.1 mg gestodene, 21 days for 13 cycles<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of pregnancy (yes/no) while on treatment |  | 13 treatment cycles each consisting of 28 days and follow-up period of 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital signs |  | 13 treatment cycles each consisting of 28 days | 
| Physical and gynecological examinations |  | 13 treatment cycles each consisting of 28 days | 
| Laboratory assessments |  | 13 treatment cycles each consisting of 28 days | 
| Adverse events (AE monitoring) |  | 13 treatment cycles each consisting of 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnancy prevention, Female contraception, Patch
Coping Skills for Alcohol Use

Study Overview
=================
Brief Summary
-----------------
A total of 120 young adults who drink to cope with negative affect will be randomized to a 4-week, web-based intervention with interactive modules on cognitive-behavioral skills (n=60) or an assessment only control (n=60). Participants will complete 4 weekly assessments and a 1- and 3-month follow-up.

Official Title
-----------------
Development of an Interactive, Web-based Drinking to Cope Intervention and Tools to Assess Coping Skill Utilization

Conditions
-----------------
Alcohol Drinking, Coping Skills

Intervention / Treatment
-----------------
* Behavioral: Drinking to Cope CBT skills


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Eligibility criteria at recruitment include: 1)18-25 years old; 2) Currently live in the state of WA, 3) Have a valid email address and phone number, 4) Drank alcohol at least once in the past month, 5) report at least 1 alcohol-related problem in the past month, 6) report using alcohol to cope with distress via negative reinforcement (i.e., to provide relief or reduction of stress or depressed mood) in the past month Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>A total of 60 young adults will be randomized to the 4-week, web-based drinking to cope intervention. | Behavioral: Drinking to Cope CBT skills<br>* Young adults who drink to cope with negative affect will receive 8 web-based modules with cognitive behavioral skills<br>|
| No Intervention: Assessment Control<br>A total of 60 young adults will be randomized to the assessment only control condition. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcohol Use | Peak number of drinks | past month | 
| Alcohol Use | Typical weekly drinking | past month | 
| Alcohol Use | Heavy Episodic Drinking | past month | 
| Alcohol Negative Consequences | Alcohol Negative Consequences | Past Month | 
| Alcohol Coping | Alcohol Coping Motives | Past Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive Symptoms | depressive symptoms | Past month |
CYP4A11 and CYP4F2 Gene Variants as Makers of Cardiovascular Adverse Events of Non-steroidal Anti-inflammatory Drugs

Study Overview
=================
Brief Summary
-----------------
Randomized, double-blinded, cross-over and placebo controlled clinical trial to evaluate the association between genetic polymorphism of CYP4F2 with cardiovascular adverse effects of non-steroidal anti-inflammatory drugs (NSAIDs). Two groups were included according the CYP4F2 V433M genetic polymorphism (control - MM, N=7 vs. VV or VM variants, N=13). According the sample size planned, a mean difference of total body water delta between groups (control vs. polymorphic) of at least allow 10% could be observed.

Official Title
-----------------
Evaluation of CYP4A11 and CYP4F2 Gene Variants as Makers in Edema and Elevated Blood Pressure Occurrence After Nonsteroidal Anti-inflammatory (NSAID) Use

Conditions
-----------------
Drug-Related Side Effects and Adverse Reactions

Intervention / Treatment
-----------------
* Drug: Diclofenac
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers 18-65 years-old - Exclusion Criteria: Use of drugs and without clinical history of adverse effects of NSAIDS -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diclofenac<br> | Drug: Diclofenac<br>* 50 mg po, b.i.d for 6 days<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Placebo po, b.i.d. for 6 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Edema | Presence of edema, measured by the estimative of total body water (deuterium oxide dilution technique). The measurements will be done in the end of 6 days of use of placebo and diclofenac, and the delta between diclofenac and placebo will be used as endpoint | after 6 days of diclofenac and placebo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure | Variation (delta) of 24h diastolic blood pressure between placebo and diclofenac phases, measured by ambulatory blood pressure monitoring (ABPM) | after 6 days of diclofenac and placebo |
Pathophysiology of Inflammation After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the dynamics of inflammatory parameters in presence or absence of infectious complications after cytoreductive surgery with hyperthermic intraperitoneal chemotherapy.

Detailed Description
-----------------
Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy is the treatment of choice in patients with primary or secondary peritoneal surface malignancies. However the survival benefit is achieved at the cost of increased morbidity and mortality due to an extensive surgery and intraoperative chemo-therapy. Among complications infectious complications are the most common. The early diagnosis of a potential fatal infection is therefore crucial to ensure a good outcome in patients.

Official Title
-----------------
Pathophysiology of Inflammation After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

Conditions
-----------------
Peritoneal Cancer

Intervention / Treatment
-----------------
* Procedure: CRS and HIPEC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive adult patients (more than 18 years) subjected to CRS and HIPEC due to peritoneal malignancy. Written informed consent by the participant after information about the research project Exclusion Criteria: No primary or secondary peritoneal surface malignancy No CRS and HIPEC Pregnancy Younger than 18 years

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 |
| --- | --- |
| CRS and HIPEC<br>Patients subjected to cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) due to primary or secondary peritoneal malignancy | Procedure: CRS and HIPEC<br>* During CRS, all visible peritoneal tumors are removed. Consequently micrometastasis are removed with hyperthermic intraperitoneal chemotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C reactive protein (CRP) mg/l, receiver operating characteristic (ROC) |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
peritoneal surface malignancies, cytoreductive surgery, hyperthermic intraperitoneal chemotherapy