linjc16/ctgov huggingface dataset:
Immune Response to Influenza Vaccination

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the immune response to a routine influenza vaccination. Influenza vaccination is given as part of routine standard of care in these individuals and is not part of the study protocol. The study will evaluate for a change in response to common antigens over time after influenza vaccination to determine if changes are related to the development of chronic rejection after solid-organ transplantation. We hypothesize that the influenza vaccine contributes to the alloreactivity of T cells verses common HLA types in the donor pool.

Official Title
-----------------
Immune Response to Influenza Vaccination

Conditions
-----------------
Solid Organ Transplantation, Chronic Kidney Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Transplant recipients (lung or kidney) 18 years or older, more than 3 months after transplantation Transplant candidates (kidney) 18 years or older, to recieve influenza vaccination Healthy volunteers to receive influenza vaccination Exclusion Criteria: Under 18 years of age Pregnant Medical contraindication for vaccine Transplant recipients receiving acute rejection therapy within one month Healthy volunteers with autoimmune disease or medications to mediate immune function Receipt of live, attenuated influenza vaccine, instead of injectable vaccine

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?
-----------------
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
-----------------
Lung Transplantation, Kidney Transplnatation, Chroinic Kidney Disease, Influenza
Measurement of Individual Level of Abortion Stigma Study

Study Overview
=================
Brief Summary
-----------------
This study is a randomized controlled trial designed to measure abortion stigma related to the Pennsylvania Abortion Control Act. Women seeking abortion will be randomized to receive the validated Individual Level Abortion Stigma Scale either before or after consent via the Pennsylvania Abortion Control Act language. The primary outcome will be the stigma scores in the two groups.

Official Title
-----------------
Measurement of Individual-Level Abortion Stigma Resulting From Pennsylvania State-Mandated Abortion Consent Language: A Pilot Randomized Controlled Trial

Conditions
-----------------
Abortion Stigma

Intervention / Treatment
-----------------
* Other: Pennsylvania State Abortion Consent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women ≥18 years old Seeking induced abortion for any indication Gestation ≤ 24 weeks Plan for procedural or state consent at current visit Willing and able to consent in English Exclusion Criteria: Have previously been consented in the current pregnancy using the Pennsylvania Abortion Control Act consent language Have previously had an abortion

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

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Participant completes a survey measuring abortion stigma prior to receiving the mandatory Pennsylvania State consent for their abortion. | |
| Experimental: Investigational<br>Participant completes a survey measuring abortion stigma after receiving the mandatory Pennsylvania State consent for their abortion. | Other: Pennsylvania State Abortion Consent<br>* Measuring the level of stigma felt pre- or post-exposure to the abortion consent language.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individual level stigma scores |  | Stigma store is collected during one 30-minute study visit, either directly prior or directly following the patient being consented using the PA Abortion Control Act language |
The Clinical Evaluation of Two Different Film Thicknesses of Clear Overlay Retainer.

Study Overview
=================
Brief Summary
-----------------
The aims of this study were to compare health related quality of life, comforts degrees，retention effectiveness, and failure rates as well as survival times between two clear overlay retainers with different thicknesses, thus to provide basis information regarding appropriate selections of the thickness of clear overlay retainers.

Conditions
-----------------
Retention

Intervention / Treatment
-----------------
* Device: retainer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients after active orthodontic treatment; Must be healthy without systemic and oral diseases; The central incisors, canines and first molars of both upper and lower arches must be existed; Agreed to the trial and signed informed consent forms, either by themselves, or their parents. Exclusion Criteria: Oral habits such as bruxism and clenching, Do not accept this type of retainers

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: retainer: 0.75-mm-thick film<br> | Device: retainer<br>* 24 h wearing whether 0.75-mm-thick or 1.00-mm-thick film retainer<br>|
| Experimental: retainer: 1.00-mm-thick film<br> | Device: retainer<br>* 24 h wearing whether 0.75-mm-thick or 1.00-mm-thick film retainer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival times via recording to the patients' re-visit |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-36 scale for Quality of life |  | one month | 
| Comfort degrees assessed through Visual Analog Score |  | one month | 
| Retention effectiveness assessed according to 3D models |  | one year |
The Effects of Surgery for Painful External Snapping Hip

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the pain-relieving effects of surgery for painful external snapping hip.

Conditions
-----------------
Hip Pain

Intervention / Treatment
-----------------
* Procedure: Surgery for external snapping hip


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing surgery for painful external snapping hip 18 years or older Exclusion Criteria: Inability to comply with the protocol (e.g. due to dementia)

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 |
| --- | --- |
| Surgery for external snapping hip<br> | Procedure: Surgery for external snapping hip<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported pain | Do you still have the same pain as before surgery? Response categories: yes; no | 1-6 years after surgery |
Expression of Steroid Receptors in Endometrium

Study Overview
=================
Brief Summary
-----------------
Expression of steroid receptors in endometrium during ovarian stimulation.

Detailed Description
-----------------
The purpose of this study is to examine in stimulated cycles a) whether there is a difference in expression of steroid receptors in stroma and glands of endometrium between different days during the follicular phase b)whether there are secretory changes detected by endometrium histology before ovulation c)whether there is an association between expression of steroid receptors in endometrium and exposure to oestradiol and progesterone during the follicular phase.

Official Title
-----------------
Expression of Steroid Receptors in Endometrium During the Early Follicular Phase in Stimulated Cycles

Conditions
-----------------
Endometrium

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treatment by IUI, BMI:18-29KGR/M2, No previous ovarian surgery, Normal hysterosalpingography, Estradiol < 80pg/ml and progesterone < 1.6ng/ml on day 2 of the cycle Exclusion Criteria: Endometriosis, Severe male factor

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 39 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Steroid receptors expression in endometrium during early follicular phase |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In which day:day o+2, day 0+4 or day HCG |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Steroid receptors, Endometrium, IVF, Follicular phase
Recurrent Urinary Tract Infections and the Microbiome

Study Overview
=================
Brief Summary
-----------------
The primary objective is to determine if polymerase chain reaction (PCR) (UTIP™) is more sensitive in identifying urinary tract infections (UTI's) than standard urine cultures.

Official Title
-----------------
Is PCR Amplification More Sensitive Than Urine Cultures in Diagnosing Urinary Tract Infections in Patients With Recurrent Bladder Infections?

Conditions
-----------------
Recurrent Urinary Tract Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 y/o-90 y/o Able to consent Female Group A only: Recurrent UTI (2 UTIs in 6 months) Group B only: No history of recurrent UTIs Exclusion Criteria: Pregnant Pelvic radiation Urinary retention (>200 ml residual) Greater than Stage 2 prolapse Renal calculi Immunosuppressed Neurologic disorder with significant bladder impairment No current UTI via dip stick

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Female participants with recurrent urinary tract infections (RUTI).<br>Patients with RUTIs (Group A) will provide two urine samples. One urine sample is a clean catch and the other is a catheterized specimen. Both will be sent for analysis. A perineal swab will also be collect and analyzed for each patient. | |
| Female control patients without RUTIs<br>Patients without RUTIs (Group B) will provide two urine samples. One urine sample is a clean catch and the other is a catheterized specimen. Both will be sent for analysis. A perineal swab will also be collect and analyzed for each patient. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of uropathogens | The proportion of uropathogens found on PCR versus urine culture from urine samples. | Day 1 | 
| Proportion of patients negative for repeat testing | The proportion of negative patient on repeat testing of urine samples. | Up to 4 weeks |
The Effect of In-vitro Myoinositol Supplementation of Human Sperm on the Outcome of Cryopreservation

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the effect of in-vitro myoinositol supplementation of human sperm on the outcome of cryopreservation.

Detailed Description
-----------------
Sperm cryopreservation is considered the most valuable and used way to preserve male reproductive function. Unfortunately, osmotic effects of freezing and thawing during the cryopreservation process negatively affect sperm morphology and motility . Myoinositol is the most biologically important form of inositol in nature. In male reproductive system, myoinositol appears to regulate sperm motility, capacitation and acrosomal reaction. The objective of this study is to evaluate the effect of in-vitro myoinositol supplementation of human sperm on the outcome of cryopreservation.

Official Title
-----------------
The Effect of In-vitro Myoinositol Supplementation of Human Sperm on the Outcome of Cryopreservation

Conditions
-----------------
Myoinositol, Cryopreservation, Human, Sperm

Intervention / Treatment
-----------------
* Biological: Myoinositol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infertile men with normal or abnormal semen analysis Exclusion Criteria: Azoospermic samples

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Normal S.A group<br>Infertile men with normal semen analysis. each sample is divided into 2 identical aliquots: one aliquot (Myo aliquot) is supplied with myoinositol, The other aliquot is left as it is (control aliquot). | Biological: Myoinositol<br> <br> |
| Active Comparator: Abnormal S.A group<br>Infertile men with abnormal semen analysis. each sample is divided into 2 identical aliquots: one aliquot (Myo aliquot) is supplied with myoinositol, The other aliquot is left as it is (control aliquot). | Biological: Myoinositol<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cryo-survival rate | Post-thawing cryo-survival rates of both aliquots ( myo and control) are compared in both groups (A and B). | 7 months |
Serological Response to mRNA and Inactivated COVID-19 Vaccine in Health Care Workers in Hong Kong

Study Overview
=================
Brief Summary
-----------------
Since the first local case of COVID-19 confirmed on 4 Feb 2020, Hong Kong has already experienced 4 waves of COVID-19 surge, with more than 9000 cases reported. A number of vaccines have been shown to be efficacious against symptomatic and severe infection by inducing neutralizing antibody (NAB) against spike protein of the SARS-CoV-2 virus. However, the duration of protection and longevity of antibody response is unknown. Health care workers (HCWs) who are planning to receive COVID-19 vaccine will be recruited. The level of antibody against spike protein by different quantitative assays will also be serially measured .

Official Title
-----------------
Serological Response to mRNA and Inactivated COVID-19 Vaccine in Health Care Workers in Hong Kong

Conditions
-----------------
Covid-19 Vaccine

Intervention / Treatment
-----------------
* Biological: CoronaVac Vaccine
* Biological: BNT162b2 Vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any staff, visiting doctor, nursing student of HKSH who are aged 18 or above No contraindication for COVID-19 vaccination and plan to receive the intended dosages at the appropriate interval. A baseline serology taken within 1 week before vaccination shows no evidence of recent infection. No history of documented COVID-19 infection Exclusion Criteria: -

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BNT162b2<br>Subjects who receive mRNA vaccine BNT162b2. | Biological: BNT162b2 Vaccine<br>* Covid-19 BNT162b2 Vaccine<br>|
| CoronaVac<br>Subjects who receive inactivated vaccine, CoronaVac. | Biological: CoronaVac Vaccine<br>* CoronaVac Vaccine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of IgG Level in the serum of healthcare workers who received COVID-19 vaccine | Change of IgG Level in the serum of healthcare workers who received COVID-19 vaccine at different points during the first six months of vaccination | 1 month, 3 months and 6 months post vaccination |
To Demonstrate the Relative Bioavailability of Sandoz Inc. and UCB Pharma, Inc (Keppra) 750 mg Levetiracetam Tablets In Healthy Adults Volunteers Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
To demonstrate the relative bioavailability of Sandoz Inc. and UCB Pharma, Inc (Keppra) 750 mg Levetiracetam tablets in healthy adult volunteers under fasting conditions.

Official Title
-----------------
Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Sandoz Inc. and UCB Pharma, Inc (Keppra) 750 mg Levetiracetam Tablets In Healthy Adults Volunteers Under Fasting Conditions

Conditions
-----------------
Seizure

Intervention / Treatment
-----------------
* Drug: Levetiracetam Tablets, 750 mg (Sandoz Inc.)
* Drug: Keppra (Levetiracetam) Tablets, 750 mg (UCB Pharma, Inc)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Levetiracetam Tablets, 750 mg (Sandoz Inc.) | Drug: Levetiracetam Tablets, 750 mg (Sandoz Inc.)<br> <br> |
| Active Comparator: 2<br>Keppra (Levetiracetam) Tablets, 750 mg (UCB Pharma, Inc) | Drug: Keppra (Levetiracetam) Tablets, 750 mg (UCB Pharma, Inc)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anticonvulsant
A Study of Oxybutynin for the Treatment of Urge Urinary Incontinence

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety of three doses of oxybutynin for the treatment of urge urinary incontinence.

Official Title
-----------------
An Open-Label, Dose Escalating Study to Evaluate the Safety of Intravaginal Oxybutynin in Subjects With Urge Urinary Incontinence

Conditions
-----------------
Urinary Incontinence, Urge

Intervention / Treatment
-----------------
* Drug: oxybutynin
* Drug: oxybutynin
* Drug: oxybutynin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females 18 to 75 years of age Has reported symptoms of urge urinary incontinence/overactive bladder Exclusion Criteria: Is pregnant or lactating Has had lower urinary tract surgery within 6 months prior to Screening Has a history of urinary retention

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: oxybutynin<br>* low dose oxybutynin administered daily<br>|
| Active Comparator: 2<br> | Drug: oxybutynin<br>* middle dose oxybutynin administered daily<br>|
| Active Comparator: 3<br> | Drug: oxybutynin<br>* high dose oxybutynin administered daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of micturations and incontinence episodes. |  | Two weeks pretreatment and three weeks on treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
urinary incontinence, urge, urinary urge incontinence, urge incontinence, over active bladder