linjc16/ctgov huggingface dataset:
Safety Profile Following Td Vaccination in Indonesian Pregnant Woman

Study Overview
=================
Brief Summary
-----------------
To assess any serious systemic reaction within 30 minutes after Td immunization in pregnant woman

Detailed Description
-----------------
Any local and systemic reaction after Td immunization in pregnant woman (as a routine immunization program)

Official Title
-----------------
Safety Profile Following Td Vaccination in Indonesian Pregnant Woman

Conditions
-----------------
Healthy, Pregnant

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Pregnant Woman aged 18-39 years old 27-36 weeks of pregnancy Subject have been informed properly regarding the study and signed the informed consent form Subject will commit to comply with the instructions of the investigator and the schedule of the trial Exclusion Criteria: Given simultaneously with other vaccines or with the interval less than 1 month with other vaccination

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 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 |
| --- | --- | --- |
| Any serious adverse event occurring from inclusion until 30 minutes after the injection | local and systemic reaction | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of local and systemic events occurring within 72 hours after each injection | any local and systemics events | 72 hours | 
| Percentage of local and systemic events occurring from 72 hours up to 28 days following injection. | any local and systemics events | 72 hours - 28 days | 
| Percentage of serious adverse events within 28 days after injection | Any serious adverse events | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Td Vaccine, Safety, Pregnant, Pregnant Women
Isovolumetric and Isocaloric Preloads of Various Types of Milk on Food Intake, Subjective Appetite and Glycemic Response

Study Overview
=================
Brief Summary
-----------------
The purpose of this protocol is to study the effects of fluid milk products on satiety, food intake, and glucose metabolism in healthy young men and women. Experiment 1: The specific objective is to investigate isovolumetric amounts of milk (2% M.F.), chocolate milk (1% M.F.), a soy beverage, cow's milk-based infant formula, and water (control) on satiety and food intake and on blood glucose before and after a meal. A fixed volume approach is based on the commercially available serving size. Experiment 2 will examine equicaloric amounts of milk (2% M.F.), chocolate milk (1% M.F.), a soy beverage, cow's milk-based infant formula, a glucose drink and water (control) the treatments in order to investigate macronutrient composition on satiety and food intake and on blood glucose before and after the meal.

Official Title
-----------------
The Effects of Isovolumetric and Isocaloric Preloads of Various Types of Milk on Food Intake, Subjective Appetite and Glycemic Response in Healthy Young Men and Women

Conditions
-----------------
Diabetes Prevention, Obesity Prevention

Intervention / Treatment
-----------------
* Other: Dietary intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Non-smoking Aged 20-30 years Body mass index between 20 and 24.9 kg/m2 Exclusion Criteria: Diabetes Medication Lactose-intolerance or allergies to milk Breakfast skippers and those on an energy restricted diet

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 30 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chocolate milk<br> | Other: Dietary intervention<br>* Dietary treatments with beverages<br>|
| Experimental: Milk<br> | Other: Dietary intervention<br>* Dietary treatments with beverages<br>|
| Experimental: Infant formula<br> | Other: Dietary intervention<br>* Dietary treatments with beverages<br>|
| Experimental: Soy beverage<br> | Other: Dietary intervention<br>* Dietary treatments with beverages<br>|
| Experimental: Water<br> | Other: Dietary intervention<br>* Dietary treatments with beverages<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food intake |  | 30 minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose |  | 0, 10, 20, 30, 50, 80, 110, 140 and 170 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Food intake, Blood glucose, Milk
Study of PBK_L1704 for the Treatment of Moderate to Severe Acute Pain After Bunionectomy in South Korea

Study Overview
=================
Brief Summary
-----------------
The primary objective is to evaluate the analgesic efficacy of PBK_L1704 compared with placebo in patients with moderate to severe acute pain after bunionectomy.

Official Title
-----------------
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of PBK_L1704 for the Treatment of Moderate to Severe Acute Pain After Bunionectomy in South Korea

Conditions
-----------------
Acute Pain

Intervention / Treatment
-----------------
* Drug: PBK_L1704 0.35mg
* Drug: PBK_L1704 0.5mg
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled to undergo primary, unilateral, first metatarsal bunionectomy with osteotomy and internal fixation Able to understand and comply with the study procedures and requirements, and able to provide written informed consent before any study procedure. Exclusion Criteria: Participated in another oliceridine clinical study. Received any investigational drug, device or therapy within 35 days before surgery. Clinically significant medical, surgical, postsurgical, psychiatric or substance abuse condition or history of such condition that could confound the interpretation of efficacy, safety or tolerability data in the study. American Society of Anesthesiologists (ASA) Physical Status Classification System classification III or worse.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 75 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
Interventional Model Description: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PBK_L1704 0.35mg<br> | Drug: PBK_L1704 0.35mg<br>* The subject will receive PBK_L1704 0.35mg/ml by PCA<br>|
| Experimental: PBK_L1704 0.5mg<br> | Drug: PBK_L1704 0.5mg<br>* The subject will receive PBK_L1704 0.5mg/ml by PCA<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* The subject will receive placebo by PCA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SPID-48 | Sum of Pain Intensity Differences (SPID) from baseline to 48 hours | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder rate | A patient is a responder if their final time-weighted Sum of Pain Intensity Differences from baseline (SPID-48) corresponds to, or is greater than, a 30% improvement. | 48 hours | 
| Time to rescue pain medication use |  | 48 hours | 
| Proportion of rescue pain medication use |  | 48 hours | 
| Total rescue pain medication use |  | 48 hours |
Safety and Efficacy of Freezing and Thawing of Human Eggs in Assisted Reproductive Technology

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effectiveness of the ViaCell's product media for freezing and thawing human eggs for future use in assisted reproductive technology.

Detailed Description
-----------------
ViaCell's product is an investigational product intended to broaden reproductive options for women through freezing and thawing of human eggs. The egg is a large cell with a high water content, historically making it difficult to freeze. It uses a choline chloride-based media designed to protect the cells from damage during the freezing process with the goal of making it possible to successfully store and thaw eggs for future use. Following informed consent, female subjects will be screened according to the inclusion/exclusion criteria of the protocol and eligible subjects will undergo hormonal stimulation using standard IVF drugs.

Official Title
-----------------
Safety and Effectiveness of Freeze and Thaw Media Kits for the Manufacturing of Oocytes for Future Use in Assisted Reproductive Technology

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

Intervention / Treatment
-----------------
* Device: Viacell's product Media Kits


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women 21-35 years of age Women with male factor infertility seeking IVF treatment Negative history of female infertility Non-smoking for at least 1 year Exclusion Criteria: Greater than one miscarriage More than one previous failed IVF attempt

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 35 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

| Intervention/Treatment |
| --- |
|Device: Viacell's product Media Kits|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IVF, Male factor infertility, Cryopreservation, Cryoprotective agents, Egg Freezing
Effects of Watermelon Juice on Heart Rate Recovery and Post-exercise Muscle Soreness

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to determine the effects of a pre-exercise, single practical dose of watermelon juice, Gatorade, sugar water or water on heart rate recovery, blood lactate levels, and 24-hour post exercise muscle soreness.

Official Title
-----------------
Effects of Watermelon Juice on Heart Rate Recovery and Post-exercise Muscle Soreness

Conditions
-----------------
Heart Rate Recovery

Intervention / Treatment
-----------------
* Other: Watermelon juice
* Other: Sport drink
* Other: Sugar water
* Other: Water


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ages of 21-50 healthy adults Exclusion Criteria: Suffering from injury Chronic inflammatory conditions Required dietary supplement use Required medication which affects blood pressure Smoking Pregnant woman Allergy to watermelon

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Watermelon juice<br> | Other: Watermelon juice<br>* Subject drinks 355ml of watermelon juice 1 hour prior to submaximal exercise<br>|
| Active Comparator: Sport drink<br> | Other: Sport drink<br>* Subject drinks 355ml of Gatorade 1 hour prior to submaximal exercise<br>|
| Active Comparator: Sugar water<br> | Other: Sugar water<br>* Subject drinks 355ml of sugar water (22.5g) 1 hour prior to submaximal exercise<br>|
| Placebo Comparator: Water<br> | Other: Water<br>* Subject drinks 355ml of water 1 hour prior to submaximal exercise<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of heart rate after submax exercise | The participants then were fitted to cycling shoes and familiarized with the Lode cycle ergometer (Lode Excalibur Sport, Groningen, Netherlands), completed a warm-up and were asked to perform a criterion work rate trial ending at 80% predicted HRmax. Heart rate was recorded every minute post exercise for a maximum of 20 minutes post exercise. | Baseline and every minute post exercise for a maximum 20 minutes post exercise. |
Study Evaluating Single Doses of ILV-095 in Healthy Japanese Male Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and tolerability of single doses of ILV-095 in healthy Japanese male subjects.

Official Title
-----------------
Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ILV-095 Administered Subcutaneously to Healthy Japanese Male Subjects

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Biological: ILV-095
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men aged 20 to 45 years inclusive at screening. Sexually active men must agree to use a medically acceptable form of contraception during the study and continue it for 12 weeks after study drug administration. Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight greater than or equal to 45 kg. Healthy as determined by the investigator on the basis of screening evaluations. Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay. Have a high probability for compliance with and completion of the study. Exclusion Criteria: Presence or history of any disorder that may prevent the successful completion of the study. Any subject who had orthopedic surgery within 12 weeks of the screening visit or has planned (elective) orthopedic surgery within 12 weeks of study drug administration. Acute disease state (eg, nausea, vomiting, infection, fever, active infection, or diarrhea) within 7 days before enrollment.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ILV-095<br>6 SC single dose injections | Biological: ILV-095<br> <br> |
| Placebo Comparator: Placebo<br>Placebo | Other: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability will be evaluated from the reported AEs including any injection-site reactions, physical examinations, vital sign measurements, cardiac rhythm monitoring, 12-lead ECGs, and clinical laboratory test results. |  | 3 weeks per group | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters |  | 3 weeks per group |
Clinical Evaluation of the Photoallergy Potential of Xenaderm Ointment

Study Overview
=================
Brief Summary
-----------------
The product is being tested to see if exposure to light causes photoallergic reactions on the skin.

Official Title
-----------------
Clinical Evaluation of the Photoallergy Potential of Xenaderm Ointment

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: Ointment Vehicle
* Drug: Xenaderm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects Exclusion Criteria: Less than 18 years

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

Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xenaderm<br>Subject serves as own control | Other: Ointment Vehicle<br>* Subject acts as own control. 20 mg under Finn chambers<br>Drug: Xenaderm<br>* 20 mg under Finn chambers<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency Distribution of Skin Irritation Scores | Scores based on skin irritation scale of 0 (no reaction) to 7 (large vesiculo-bullous reaction) in whole units. Photoallergic reactions were characterized by irritation scores of 3 or higher. | 48-hours post irradiation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
wound healing, photoallergenicity, Healthy subjects
Study of the Sars-Cov2 Neuroinvasiveness - COVID19

Study Overview
=================
Brief Summary
-----------------
Sars-Cov2 (COVID-19) may invade the CNS inducing neurological diseases such as anosmia, ageusia, encephalitis, ischemic or hemorrhagic stroke. Management of severe neurological complications in COVID-19 patients may require ventricular cerebrospinal fluid drainage and cranial decompression. During surgery, cerebrospinal fluid, meninges and brain parenchyma can be safely removed from the patient. In this study, COVID-19 patients will be evaluated first, for the presence of Sars-Cov2 in the cerebrospinal fluid and/or biopsies and second, for the consequences of Sars-Cov2 neuroinfection in terms of inflammatory and immune responses.

Official Title
-----------------
Study of the Sars-Cov2 Neuroinvasiveness - COVID19

Conditions
-----------------
COVID19

Intervention / Treatment
-----------------
* Drug: Cerebrospinal fluid sampling, meningeal and brain parenchyma biopsies


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COVID-19 patients requiring an external ventricular drain, a decompressive craniectomy or an intracranial hematoma surgery Exclusion Criteria: Pregnant or lactating women

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neurological biological samples<br> | Drug: Cerebrospinal fluid sampling, meningeal and brain parenchyma biopsies<br>* Cerebrospinal fluid sampling, meningeal and brain parenchyma biopsies<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with COVID-19 positive samples/biopsies | COVID-19 RT-PCR test | At the time of the inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sars-Cov2 neuroinvasiveness, COVID-19 RT-PCR test
Study on Complications, EfficAcy and Costs of Large Polypectomy

Study Overview
=================
Brief Summary
-----------------
Colonoscopy has been shown to reduce the incidence and mortality of colorectal cancer, through the recognition and removal of pre-cancerous lesions, which in most cases evolve with a sequence that goes through formation of high-grade dysplasia (HGD). The probability of HGD increases with the increase of the lesion of the polyp itself. Lesions> 2 cm are present in 1% of colonoscopy screening. The resection of these lesions presents a greater technical difficulty and consequently a decrease in the efficiency. The rate of incomplete resection reported in the literature reaches 10% while that of recurrence / residual adenoma 16.4 / 31.7%. The aim of the study SCALP is to evaluate the incidence of complications, efficacy and cost of endoscopic resection of colic lesions> 2cm in a setting of clinical practice in an unselected population

Conditions
-----------------
Polypectomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients undergoing large endoscopic polypectomy Exclusion Criteria: pregnancy incapacity to give informed consent

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| colonoscopy population<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications of large polypectomy | incidence of polypectomy-related adverse events | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| costs of large polypectomy | assessment of the average cost per procedure, including devices and staff costs | 15 days | 
| efficacy of large polypectomy | assessment of residual adenoma at follow-up | 6 months |