linjc16/ctgov huggingface dataset:
Usefulness of Home Pregnancy Testing

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine whether women in a Medicaid population at risk for unintended pregnancy will keep a home pregnancy test on hand and (if necessary) use it appropriately.

Detailed Description
-----------------
Once pregnancy is recognized, most women seek prompt prenatal care and try to stop risk behaviors. Unfortunately, women with unintended pregnancies do not recognize their pregnancies promptly, and inadvertently continue risk behaviors into the vulnerable early pregnancy weeks. Home pregnancy testing is a rapid and inexpensive means of pregnancy diagnosis. The objective of this study is to determine whether women in a Medicaid population at risk for unintended pregnancy will keep a home pregnancy test on hand and (if necessary) use it appropriately

Official Title
-----------------
Utility of Home Pregnancy Testing in Medicaid Women at Risk for Unintended Pregnancy

Conditions
-----------------
Fertility

Intervention / Treatment
-----------------
* Behavioral: Education for pregnancy planning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 18 to 34 year old female, sexually active, not pregnant, not desiring pregnancy, not surgically sterile, intercourse at least once in the past 6 months without using effective contraception (hormonal or barrier or male vasectomy) receiving Medicaid OR child on Medicaid OR Medicaid paid for prev. preg understands written/spoken English enough to give informed consent and respond to survey Exclusion Criteria: fails to meet inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 34 Years

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

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

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 |
| --- | --- |
| Experimental: Pregnancy Test Group<br>Group got free home pregnancy test kits | Behavioral: Education for pregnancy planning<br>* Provision of free home pregnancy tests to women at risk for unintended pregnancy<br>* Other names: Home pregnancy testing;|
| No Intervention: 2<br>Group did not receive free home pregnancy test kits | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of episodes of use of home pregnancy test kits |  | 6 month followup | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge about use of home pregnancy test kits |  | 6 months | 
| Episodes of pregnancy suspicion |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pregnancy, unintended, menses
Neoadjuvant Study of Navelbine in Patients With HER2 Positive Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This is a randomized, double-blind multicenter Phase III study for evaluating the efficacy of neoadjuvant Navelbine plus trastuzumab and Pertuzumab versus Docetaxel plus trastuzumab and Pertuzumab given as neoadjuvant treatment in HER2 positive early-stage or locally advanced breast cancer.

Official Title
-----------------
A Study to Evaluate Navelbine in Combination With Trastuzumab Plus Pertuzumab in Patients With HER2 Positive Early Stage or Locally Advanced Breast Cancer in Neoadjuvant Treatment

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: Navelbine
* Drug: Docetaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients, 18 years ≤ age ≤ 80 years； Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1 Histologically confirmed invasive breast cancer（early stage or locally advanced） HER2 positive (HER2+++ by IHC or FISH+) Known hormone receptor status. Cardiovascular: Baseline left ventricular ejection fraction (LVEF)≥55% measured by ECHO Signed informed consent form (ICF) Exclusion Criteria: Metastatic disease (Stage IV) or inflammatory breast cancer Previous or current history of malignant neoplasms, except for curatively treated: Basal and squamous cell carcinoma of the skin, Carcinoma in situ of the cervix. Clinically relevant cardiovascular disease: Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110); Unable or unwilling to swallow tablets.

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

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

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

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 |
| --- | --- |
| Experimental: NHP<br>Navelbine, Herceptin, Pertuzumab | Drug: Navelbine<br>* Navelbine 25mg/m2 on day 1 and 8, every 3 weeks<br>|
| Active Comparator: THP<br>Docetaxel, Herceptin, Pertuzumab | Drug: Docetaxel<br>* Docetaxel 90mg/m2 on day 1, every 3 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pCR | Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery. | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DFS | Disease-free Survival | Following surgery until Year 3 | 
| DDFS | Distance Disease-free Survival | Following surgery until Year 3 | 
| ORR | Objective Response Rate | Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months |
Prevalence of Human Papillomavirus in Men Living in the Northern Plains

Study Overview
=================
Brief Summary
-----------------
HPV infection is associated with cervical and other anogenital cancers. HPV may also be associated with the development of prostate cancer. The purpose of the study is to determine the prevalence of HPV infection in men living in South Dakota.

Official Title
-----------------
Prevalence of Human Papillomavirus in Men Living in the Northern Plains

Conditions
-----------------
Human Papillomavirus Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male Ages 18-65 Living in South Dakota (AKA Northern Plains) Exclusion Criteria: -

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

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

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 |
| --- | --- | --- |
| Determine the prevalence of HPV in men living on the Northern Plains |  | No time point |
Register of Blood Stem Cell Transplantation

Study Overview
=================
Brief Summary
-----------------
Register of patients with blood stem cell transplantations (autologous, allogen).

Detailed Description
-----------------
Documenting the success rate in terms of complication rate, disease response, survival rate, engraftment, and details of transplantation settings, for example donor and conditioning data, remission status before transplantation. It's a register of patients who have one or more autologous and / or allogenic blood stem cell transplants due to an existing indication for performing myeloablative / non-myeloablative high-dose chemotherapy. The inclusion occurs at our center during preparation for blood stem cell transplantation. The written consent will be obtained separately in the context of the information on blood stem cell transplantation. Participation is voluntary and consent can be revoked at any time. This involves no additional effort for the patient and has no influence on his treatment. It may be necessary in the course of contacting the patient at home, as long as the data is incomplete. This is also explicitly explained. A copy of the declaration of consent is given to the patient.

Official Title
-----------------
Register of Survey and Evaluation of Blood Stem Cell Transplantations of Clinic III of Internal Medicine III

Conditions
-----------------
Hematologic Malignancies

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: signed IC patients eligible for stem cell transplantation Exclusion Criteria: unable to consent to study participation

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Register of stem cell transplantation | Recording of all stem cell transplantations over many years | approximately over 20 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Register of toxicities | Recording of toxicities occured during and after SCT according to GvHD Score Standards and blood and bone marrow samples, and Imaging (CT Scans) | approximately over 20 years | 
| Register of complications | Recording of complications occurred during and after SCT in Terms of infectious complications and occurance of GvHD (according to GvHD Score and Imaging and clinical assessment) | approximately over 20 years | 
| Register of morbidities |  | approximately over 20 years | 
| Register of survivals | Recording of survival Status, Assessment of Remission Status by bone marrow and blood diagnostics, clinical follow up | approximately over 20 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
autologous & allogenic blood stem cell transplantations
Prebiotic Effects of a Polyphenol-rich Food Product

Study Overview
=================
Brief Summary
-----------------
The specific aim for this project will be to investigate a cranberry beverage as a means to restore balance in terms of the relative proportions of the various bacteria that inhabit the large intestine.

Official Title
-----------------
Prebiotic Effects of a Polyphenol-rich Food Product

Conditions
-----------------
Dysbiosis

Intervention / Treatment
-----------------
* Other: Cranberry beverage
* Other: Placebo beverage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 27-35 kg/m2 High waist circumference (men >102 cm and women >88 cm) Exclusion Criteria: Cigarette smoking Regular intensive exercise Pregnancy or lactation Chronic diarrhea, constipation, or other gastrointestinal complaint Diabetes mellitus, autoimmune disease, or other chronic disease known to alter the gut microbiota Use of medications that affect inflammation or the gut microbiota Use of prebiotics, probiotics, synbiotics, vitamins, or other dietary supplements known to affect the gut microbiota Aversion to cranberries Food allergies Lactose intolerance Vegetarianism

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cranberry beverage<br> | Other: Cranberry beverage<br>* During the intervention period, research participants will consume a cranberry beverage daily.<br>|
| Placebo Comparator: Placebo beverage<br> | Other: Placebo beverage<br>* During the intervention period, research participants will consume a placebo beverage daily.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal microbial community composition and structure | We will investigate if specific bacterial taxa are stimulated by daily consumption of a cranberry beverage. | Changes in the fecal microbiota will be measured after a 20-day intervention period |
Pre-Approval Access to Golimumab Subcutaneous for the Treatment of Stage 3 Type-1 Diabetes Mellitus in Children and Young Adults

Study Overview
=================
Brief Summary
-----------------
This is a Single Patient Investigational New Drug (IND) to golimumab subcutaneous (SC) for the treatment of recently diagnosed Stage 3 type-1 diabetes mellitus (T1D) in children and young adults. The main purpose of a single patient IND is to provide treatment to participants with serious/life-threatening diseases or conditions prior to marketing authorization.

Official Title
-----------------
SIMPONI SC Managed Access Program

Conditions
-----------------
Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: Golimumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: -

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Golimumab|Participants will receive subcutaneous (SC) golimumab, where doses will be based on weight and/or body surface area.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Dermatological Evaluation of Topic Compatibility-Dermacyd Tina Gel Tangerina Mix

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Tina Gel Tangerina Mix

Official Title
-----------------
Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd Tina Gel Tangerina Mix.

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

Intervention / Treatment
-----------------
* Drug: Lactic acid (Dermacid)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Phototype Skin I,II, III e IV Integral skin test in the region Exclusion Criteria: Lactation or gestation Use of Antiinflammatory and/or immunosuppression drugs Personnel history of atopy History of sensitivity or irritation for topic products Active cutaneous disease Use of new drugs or cosmetics during the study The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lactic acid (Dermacid)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The absence of primary and accumulated dermal irritability and dermal sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale. |  | six weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hygiene
Longitudinal Study of Asymptomatic Rotator Cuff Tears

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to analyze the natural course of asymptomatic rotator cuff tears.

Detailed Description
-----------------
Fifty subjects with an asymptomatic rotator cuff tear were identified in an earlier study. Clinical, sonographic and MRI reexamination of these subjects is performed after an interval of three years. Findings of interest include: (1) the symptomatic status of the subjects (still asymptomatic or symptomatic); (2)tear size on sonography and MRI (unchanged or increased); (3)degree of muscle atrophy on MRI (unchanged or deteriorated); (4)degree of fatty muscle degeneration on MRI (unchanged or deteriorated). We want to analyze whether a change in these tear characteristics is associated with a change of the symptomatic status of these subjects.

Official Title
-----------------
Longitudinal Study of Asymptomatic Rotator Cuff Tears. A Eight Year Follow-up of Symptomatic Status and Tear Characteristics Like Tear Size, Muscle Atrophy and Fatty Degeneration

Conditions
-----------------
Rotator Cuff Tear

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with an asymptomatic rotator cuff tear at least in one shoulder, tear demonstrated both on MRI and sonography, ASES score exceeding 90 points Exclusion Criteria: Earlier periods with shoulder pain and dysfunction, earlier treatment for shoulder problems
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 |
| --- | --- |
| Asymptomatic rotator cuff tear<br>Subjects identified with an asymptomatic rotator cuff tear | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms from a rotator cuff tear | The symptomatic status of initially asymptomatic rotator cuff tears is followed up by reexamination after three and eight years | 8 years | 
| Tear characteristics on MRI and sonography | Tear characteristics from initially asymptomatic rotator cuff tears are followed up by reexamination by MRI and sonography after three and eight years | 8 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rotator cuff tear, asymptomatic, natural course, tear characteristics, Asymptomatic rotator cuff tears, Natural course of rotator cuff tears
Spinal Anesthesia Versus Combined Sciatic-femoral Nerve Block for Outpatient Knee Arthroscopy

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to compare the time of home discharge in day-case patients receiving either a spinal anesthesia or a combined sciatic-femoral nerve block for knee arthroscopy

Detailed Description
-----------------
Two groups: the first receive a spinal anesthesia injecting 2% hyperbaric prilocaine 40 mg with the patients in lateral decubitus and the surgical limb declive, the second a combined ultrasound-guided sciatic-femoral nerve block injecting 25 ml of 2% mepivacaine solution. Onset time, performance time, duration of the block, time of voiding, as well as the time of home discharge will be evaluated.

Official Title
-----------------
Spinale Unilaterale o Blocco Nervoso Periferico Per le Artroscopie di Ginocchio in Day Surgery. Confronto Prospettico Randomizzato

Conditions
-----------------
Knee Arthritis

Intervention / Treatment
-----------------
* Drug: prilocaine
* Drug: mepivacaine
* Procedure: Sciatic-femoral Nerve Block
* Procedure: Spinal anesthesia
* Device: Sonoplex, Pajunk


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: outpatients knee arthroscopy Exclusion Criteria: diabetes allergy to local anesthetic patient refusal chronic opiods assumption

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spinal anesthesia<br>Intrathecal injection of 2 ml (40 mg) of 2% hyperbaric prilocaine at L3-L4 interspaces through a 100mm Sprotte 25 G spinal needle (Pencan, b-brawn, Germay) in lateral decubitus position, (with limb to operate declive). | Drug: prilocaine<br> <br> * Other names: prilotekal;Procedure: Spinal anesthesia<br>* intrathecal injection of 40 mg hyperbaric prilocaine<br>|
| Active Comparator: peripheral nerve block<br>Ultrasound-guided sciatic-femoral nerve block injecting 25 ml of a 2% mepivacaine solution,15 ml on femoral nerve and 10 ml on sciatic nerve through a 80 mm 22g eco-reflex needle (Sonoplex, Pajunk, Germany) | Drug: mepivacaine<br> <br> * Other names: carbocaine;Procedure: Sciatic-femoral Nerve Block<br>* ultrasound-guided 25 ml 2% mepivacaine injection on both femoral and sciatic nerve<br>Device: Sonoplex, Pajunk<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to home discharge |  | 12 hours |
Study to Evaluate the Safety and PK of UI018

Study Overview
=================
Brief Summary
-----------------
This Study is to evaluate the safety and pharmacokinetics of a fixed dose combination formulation and co-administration.

Official Title
-----------------
A Randomized, Open, Single-dose, 2x2x4 Replicate Crossover-design Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics After Co-administration of UIC201806 and UIC201602 or Administration of UI018 in Healthy Volunteers

Conditions
-----------------
Hyperlipemia, Mixed

Intervention / Treatment
-----------------
* Drug: administration of UI018
* Drug: co-administration of UIC201806 and UIC201602


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects between the ages of 19 and 45 years at screening Subjects whose body weight over 55 kg and ranged ± 20% of calculated Ideal body Weight(IBW) [ IBW (kg) = (height(cm) - 100) x 0.9 ] Subjects able to read and understand a written informed consent, and willing to decide to participate in the study.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 45 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: UI018<br> | Drug: administration of UI018<br>* Test<br>|
| Active Comparator: UIC201806 and UIC201602<br> | Drug: co-administration of UIC201806 and UIC201602<br>* Reference<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum concentration(Cmax) |  | 0 to 96 hrs | 
| area under the curve(AUC) |  | 0 to 96 hrs |