linjc16/ctgov huggingface dataset:
Long-Term Outcome of Children and Adolescents With Anti-Phospholipid Antibodies

Study Overview
=================
Brief Summary
-----------------
This is a study about why some people have certain types of proteins in their blood, called anti-phospholipid antibodies. The presence of these antibodies and associated complications (e.g. blood clots) are known to change over time. The purpose of this study is to evaluate these changes and improve our ability to determine the long-term outcome of affected individuals.

Detailed Description
-----------------
Aim: Determine the incidence, and time frame, for aquiring aPL in a cohort of aPL-negative pediatric SLE subjects. Determine the incidence, and time frame, for developing a first APS-associated complication among SLE subjects with detectable aPL. Determine the incidence, and time frame, for developing a second APS-associated event among subjects with a history of an APS-associated event. Determine the incidence, and time frame, for developing SLE among subjects with a history of an APS-associated event in the absence of SLE. Identify laboratory and clinical predictors for the events described in aims 1-4.Research Design and Methods: This is a prospective cohort study to determine the risk of developing aPL or APS-related symptoms in a young group of SLE and APS subjects. Patients will be followed over a ten year period and will undergo annual serologic and clinical evaluations to identify disease progression.

Official Title
-----------------
Long-Term Outcome of Children and Adolescents With Anti-Phospholipid Antibodies

Conditions
-----------------
Lupus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: Less than 21 years at baseline exam Diagnosis: patients must meet criteria for one of five diagnostic categories based on classification according to three parameters; aPL positivity, APS criteria, and SLE criteria. The five diagnostic categories are: SLE with no aPL SLE with aPL, but without manifestations of APS SLE-like APS SLE with APS Primary APS. Exclusion Criteria: none

Ages Eligible for Study
-----------------
Maximum Age: 21 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 |
| --- | --- |
| Observation<br>Those with a condition | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate changes and improve ability to determine the long-term outcome of affected individuals |  | Ten years |
Uterotonic Efficacy of Oxytocin 2.5 Versus 10 Units During Caesarean Section at Mulago Hospital

Study Overview
=================
Brief Summary
-----------------
The purpose of the study was to determine whether 2.5 international units of oxytocin gives adequate uterine tone and is safe as compared to 10 international units of oxytocin following caesarean section delivery at Mulago hospital.

Official Title
-----------------
Uterotonic Efficacy of Oxytocin 2.5 Versus 10 Units During Caesarean Section at Mulago Hospital; Adouble Blinded Clinical Trial.

Conditions
-----------------
Adverse Effect of Oxytocic Drugs, Uterine Hemorrhage, Inappropriate Dose of Drug Administered

Intervention / Treatment
-----------------
* Drug: 2.5 units Oxytocin
* Drug: 10 units Oxytocin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I (Healthy patient with no systemic disease) or II ( mild to moderate systemic disease) Age between 18 to 40 years Singleton pregnancies Exclusion Criteria: • Allergy to oxytocin Ruptured uterus Significant obstetric disease (including Pregnancy induced Hypertension, Eclampsia,) Known risk factors for postpartum haemorrhage or uterine atony Inherited or acquired coagulation disorder History of post partum haemorrhage

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2.5 units oxytocin<br>Administration of 2.5 units of oxytocin intravenously after clamping of umbilical cord | Drug: 2.5 units Oxytocin<br>* Administration of 2.5 units of oxytocin after clamping of umbilical cord<br>* Other names: pitocin;|
| Placebo Comparator: 10 units oxytocin<br>Administration of 10 units of oxytocin after clamping of umbilical cord | Drug: 10 units Oxytocin<br>* Administration of 10 units of oxytocin after clamping of umbilical cord<br>* Other names: pitocin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uterine tone adequacy | The primary outcome was the assessment of either adequate or inadequate Uterine tone at various times after administration of initial oxytocin dose | 2 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative blood loss | Blood loss was estimated by measuring the amount in the suction bottles and weighing of the mops. The patients were followed up for any occurrence of postpartum haemorrhage for the next 24 hours after surgery. | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oxytocin, Uterine tone, Mulago Hospital, Dose, Side effects
Two-year Surveillance of Rotavirus Genotypes Causing Acute Diarrhea in Children Younger Than 5 Years Requiring Emergency Room (ER) and Hospital Admission in Chile

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to prospectively determine the rotavirus VP7/VP4 genotypes associated with moderate to severe disease (requiring emergency room (ER) consult or hospitalization) in a large public hospital from Valparaiso and another from Santiago.

Detailed Description
-----------------
Rotavirus is the leading cause of gastroenteritis in children. Our group has developed a surveillance system for acute rotavirus diarrhea in two large hospitals in Chile since 2006. Patients visiting the ER for acute non-bloody diarrhea will be enrolled after an informed consent is signed by parents. A fresh stool sample will be collected to prospectively determine the rotavirus VP7/VP4 genotypes associated with moderate to severe disease (requiring emergency room (ER) consult or hospitalization. Stool samples will be tested for rotavirus by ELISA IDEIA - Rotavirus - OXOID. Rotavirus positive samples will be genotyped as described previously (Iturriza-Gomara et al. J. Clinical Virol 2004). Overall medical visits and hospitalizations, proportion of visits and hospitalizations caused by acute diarrhea, estimated numbers of rotavirus visits and hospitalizations will be calculated for each site. Proportion of rotavirus VP7 and VP4 genotypes will be calculated for three month periods per center. Differences in proportion will be compared by chi square and Fischer's exact test when appropriate.

Official Title
-----------------
Two Year (2009-2010) Surveillance of Rotavirus Genotypes Causing Acute Diarrhea in Children Younger Than 5 Years of Age Requiring Emergency Room and Hospital Admission in Two Large Cities in Chile.

Conditions
-----------------
Acute Diarrheal Disease, Rotavirus Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with acute diarrhea Children younger than 5 years Exclusion Criteria: Illiterate parents Chronic gastrointestinal disease

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 5 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 |
| --- | --- |
| Sotero del Rio<br>Emergency Room and Hospital based surveillance | |
| Van Buren<br>Emergency Room and Hospital based surveillance | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of rotavirus VP7 and VP4 genotypes |  | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of rotavirus positive episodes |  | two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diarrhea, rotavirus, genotype, VP4, VP7
Clinical Efficacy and Safety of Autologous Cultured Keratinocyte Cell on Severe Burn Wood

Study Overview
=================
Brief Summary
-----------------
The efficacy and safety of Autologous cultured keratinocyte cell on severe burn wound.

Official Title
-----------------
Clinical Study for Evaluation of Clinical Efficacy and Safety of Autologous Cultured Keratinocyte Cell on Severe Burn Wood

Conditions
-----------------
Burn Wound

Intervention / Treatment
-----------------
* Drug: Autologous cultured keratinocyte cell


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age : 1 70 years More than 30% TBSA of second degree burn or more than 10% TBSA of third degree burn Must provide signed informed consent prior to participation in any study-related procedures Exclusion Criteria: Have a pyogenic infection Part of the facial cosmetic surgery cost Hypersensitivity reactions in patients with bovine proteins Hypersensitivity reactions in patients with Gentamycin Pregnancy or lactation

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 70 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

| Intervention/Treatment |
| --- |
|Drug: Autologous cultured keratinocyte cell|3x10^7 cell/ vial|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| engraftment assessment |  | 4week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the vancouver burn scar scale |  | 8, 12, 24 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Keratinocyte Cell, severe burn wound
A Prospective Study of a New Immunological Fecal Occult Blood Test

Study Overview
=================
Brief Summary
-----------------
The purpose of the investigators study is to evaluate the diagnostic ability of a new immunological fecal occult blood test in Cuban patients undergoing colonoscopy .

Detailed Description
-----------------
Colorectal cancer is a major cause of cancer deaths in many countries. Therefore, the importance of screening for the early detection of colorectal cancer is evident. Fecal occult blood screening is proving to be an effective tool for detecting premalignant adenomas and colon cancer since the guaiac-based test was introduced in the late 1960s. However, several immunochemical fecal occult blood tests (IFOBTs) have become commercially available and the majority of these have demonstrated equal or superior sensitivities and specificities than the guaiac-based tests. Therefore, IFOBTs are replacing guaiac based tests despite their higher costs.In this study we evaluate the diagnostic accuracy of a new IFOBT and compare with the findings on colonoscopy.

Official Title
-----------------
A Prospective Study of a New Immunological Fecal Occult Blood Test in Patients Referred for Colonoscopy

Conditions
-----------------
Colonoscopy, Occult Blood, Immunologic Tests

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients (men or women) that are >18 years of age referred to colonoscopy. Exclusion Criteria: Visible rectal bleeding Known diagnosis of inflammatory bowel disease Hematuria Menstruation at the time of obtaining a stool specimen Patients taking medication such as non steroids anti inflammatory drugs and anticoagulants

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Colonoscopy indication<br>All outpatients referred to colonoscopy according to inclusion criteria in the specified period time of one year . | |

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
-----------------
Colonoscopy, Occult Blood, Fecal
Study Into Treatment of Hyperplasia of Mammary Glands

Study Overview
=================
Brief Summary
-----------------
Hyperplasia of Mammary Glands is a complex disease, and there is no consensus or guideline for the treatment of this disease. This study was launched to investigate into the problem that which patients should be diagnosed as hyperplasia of mammary glands and which patients should be treated.

Detailed Description
-----------------
Females who meet the inclusion criteria will receive breast ultrasonography, mammography and pathological examinations by core needle biopsy. All participants will receive a follow-up at an 6-month interval for 2 years. During the follow-up period, whether the symptoms relieve will be evaluated.

Official Title
-----------------
Study Into Treatment of Hyperplasia of Mammary Glands

Conditions
-----------------
Hyperplasia

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Reported breast pain or breast lumps. Willing to be kept follow-up. Functions below are maintained in major organs: liver, renal and heart. Written informed consent will be obtained for patients for entering this study. Exclusion Criteria: Typical breast cancer or fibroadenoma. Classification by breast ultrasonography of mammography is beyond Breast Imaging - Reporting And Data System (BI-RADS) 4. Oral contraceptive or hormone replacement therapy. History of breast cancer or other malignancies. History of pituitary gland disease. Potentially pregnant, pregnant, or breast-feeding.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| case group<br>cases who presented as breast pain or breast lumps, and no intervention will be administered. | Other: No intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical manifestations as an substitutive indicator for pathological diagnosis of hyperplasia of mammary glands |  | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical manifestations as an surgical indications for hyperplasia of mammary glands |  | 8 months |
Blood Levels of Ketamine in Patients Using Topical Application of 10% Ketamine Gel for Neuropathic Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to measure how much, if any, ketamine is absorbed into the blood stream after ketamine gel is applied to the skin. The investigators expect that the topical administration will provide pain relief locally, at the site of pain, but not be absorbed into the bloodstream and thus not cause side effects. This research will help assess the safety of this drug by measuring the blood concentrations of the drug. Ketamine is a general anesthetic drug but also has excellent pain relieving qualities. It has been used to relieve chronic pain by administering intravenously, by mouth, or as an injection beneath the skin. When given these ways ketamine can occasionally cause side effects like dizziness, nausea, nightmares, agitation, hallucinations. Recently it has been used topically for patients with neuropathic pain in order to avoid the dizziness and nausea side effects. Neuropathic Pain can be partially caused by the misfiring of small nerve fibers close to the area of pain. By applying it on the skin, it is expected the drug can penetrate the skin and act directly on the small nerve fibers. The advantage is that less drug will get into the blood circulation. Up to now, it has not been carefully studied how much of the drug appears in the circulation after application on the skin.

Official Title
-----------------
Plasma Concentrations of Ketamine and Norketamine in Patients Using Topical Application of 10% Ketamine for Neuropathic Pain.

Conditions
-----------------
Neuropathic Pain.

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with peripheral, focal neuropathic pain such as or complex regional pain syndrome following surgery, bony, soft tissue trauma or nerve trauma, associated with significant allodynia and hyperalgesia who score equal to or greater than 4 in the DN4 questionnaire. Duration of pain more than 3 months. Ability to speak English adequately to consent to and participate in the study Exclusion Criteria: Allergy to ketamine Severe medical illnesses like, e.g. unstable angina, tachyarryhthmias, renal or hepatic failure History of psychosis. Patients who are already on oral ketamine treatment. Patients who are taking HIV Antiretrovirals: (indinavir, nelfinavir, ritonavir saquinavir); Antibiotics: (clairithromycin, itraconazole, ketoconazole, telithromycin,fluconazole, erythromycin); Calcium Channel Blockers (verapamil, diltiazem),Amiodarone, Ciprofloxacin. (These drugs inhibit CYP 3A4 enzyme which metabolises ketamine)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
Health Consequences of the Burden of Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
The Swiss-AF-BURDEN study will be embedded in the follow-up visits of the Swiss-AF cohort study. The research question of the current atrial fibrillation burden will be answered by using 7-day Holter-ECG recordings and continuous implanted loop recorder recording, whereas cardiac MRI examination will give results about cardiac dimensions and function. The 7-day Holter ECG will be repeated after one year. The cMRI will be performed separately or directly after the brain MRI to minimize the additional burden for the patients. Only a subsample of 100 patients will additionally receive ILR for 2 years.

Official Title
-----------------
Health Consequences of the Burden of Atrial Fibrillation - The Swiss-AF-BURDEN Study

Conditions
-----------------
Atrial Fibrillation, Burden

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Swiss-AF study patient Paroxysmal or persistent AF Exclusion Criteria: Permanent AF Swiss-AF patients not willing or able to undergo 7-day Holter monitoring Specifically for cMRI: Pregnant women or women of child-bearing age without a prior negative pregnancy test

Ages Eligible for Study
-----------------
Minimum Age: 45 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 |
| --- | --- | --- |
| AF-burden | The burden of AF is defined as the amount of time (percentage) in AF during rhythm monitoring | Baseline to FU year 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overt and covert stroke |  | Baseline to FU year 2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial Fibrillation, Burden
Laryngomicrosurgery Under NIDP General Anesthesia Supported by THRIVE

Study Overview
=================
Brief Summary
-----------------
Laryngomicrosurgery requires deep paralysis and general anesthesia to finish the procedure. After the procedure, patients need a long time to recover. In the present study, with the support of the transnasal humidified rapid-insufflation ventilatory exchange, laryngomicrosurgery would be finished under nonintubated deep paralysis (NIDP) general anesthesia. In this case series study, the investigators will test the safety and feasibility of such a technique.

Official Title
-----------------
Laryngomicrosurgery Under Nonintubated Deep Paralysis (NIDP) General Anesthesia Supported by Transnasal Humidified Rapid-insufflation Ventilatory Exchange: A Case Series Study

Conditions
-----------------
Vocal Polyp

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective polypectomy of unilateral vocal cord age between 18 to 40 be able to communicate estimated operation time less than 15min ASA I-II Agree to sign written informed consent Exclusion Criteria: pregnancy or breastfeeding women severe gastrointestinal reflex disease neuromuscular disease body mass index(BMI)>30 predictable difficult airway. allergy to medicine would be used in the present study including propofol, remifentanil or sugammadex

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- | --- |
| Success rate of laryngomicrosurgery | complete the surgery within 15min,nonintubated,remove the polyp entirely,recover completely after surgery, no major adverse event | From the day before surgery till 2 days after surgery or before discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total days that participants stay in hospital |  | Through study completion, an average 2 days. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laryngomicrosurgery, Nonintubated deep paralysis, Transnasal Humidified Rapid-insufflation Ventilatory Exchange