linjc16/ctgov huggingface dataset:
Aromatherapy as Treatment for n/v of Pregnancy

Study Overview
=================
Brief Summary
-----------------
A double-blinded randomized controlled trial comparing essential oil aromatherapy versus placebo for treatment of first trimester nausea and vomiting of pregnancy.

Detailed Description
-----------------
This is a double-blinded randomized controlled trial investigating the utility of essential oils for aromatherapy, compared to placebo, for treatment of nausea and vomiting in the first trimester of pregnancy.

Official Title
-----------------
Aromatherapy as Treatment for Nausea and Vomiting of Pregnancy

Conditions
-----------------
Pregnancy Emesis

Intervention / Treatment
-----------------
* Other: Aromatherapy
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnancy at <14 weeks gestation English-speaking Baseline PUQE score >=6 Exclusion Criteria: Non-compliant with prenatal care or study procedures Hyperemesis gravidarum Allergies to perfumes, essential oils or cosmetics Abnormal sense of smell Known acute or chronic GI disease Asthma Use of prescription anti-emetics

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aromatherapy<br>Aromatherapy using essential oils | Other: Aromatherapy<br>* Aromatherapy using essential oils<br>|
| Placebo Comparator: Placebo<br>Aromatherapy using odorless placebo | Other: Placebo<br>* Aromatherapy using odorless placebo oil<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean difference in Pregnancy-Unique Quantification of Emesis (PUQE) score | PUQE score is a validated measure of nausea and vomiting in pregnancy. It is a reliable tool used to measure the severity of nausea and vomiting of pregnancy. It is a questionnaire that measures the number of times in 24 hours a patient wretches, vomits, or feels nauseous. The minimum score is 3, and the maximum is 15. Participants will have PUQE scores calculated at baseline (during enrollment in the first trimester of pregnancy, at whatever age they are at), and after one month of aromatherapy use with either essential oils or placebo, with the mean difference from baseline compared as primary outcome. The Time Frame for participation will be from enrollment until the end of the first trimester (13th week of pregnancy), which, depending on gestational age in weeks at enrollment, may be up to 8 weeks. | First trimester of pregnancy |
A Platform for Multidisciplinary Medical Artificial Intelligence Development

Study Overview
=================
Brief Summary
-----------------
Biomedical deep learning (DL) often relies heavily on generating reliable labels for large-scale data and highly technical requirements for model training. To efficiently develop DL models, we established an integrated platform to introduce automation to both annotation and model training-the primary process of DL model development. Based on this platform, we quantitively validated and compared the annotation strategy and AI model development with the pure manual annotation method performed on medical image datasets from multiple disciplines.

Official Title
-----------------
A Platform for Multidisciplinary Medical Artificial Intelligence Development

Conditions
-----------------
Medical Artificial Intelligence, Medical Imaging

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: have medical imaging record (including ophthalmology, pathology, radiography, blood cells, and endoscopy) Exclusion Criteria: unqualified medical imaging
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 |
| --- | --- |
| human-machine collaboration group<br>healthcare professionals and machine collaboration for annotation and AI model development | |
| pure mannual group<br>healthcare professionals for pure manual annotation and AI model development | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| annotation accuracy | calculate annotation accuracy for comparison between groups with using the annotation results | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accuracy of model performance | calculate AI model accuracy for comparison between groups with using the model predicted results | baseline | 
| AUC of model performance | calculate AI model AUCs for comparison between groups with using the model predicted results | baseline | 
| annotation time cost | calculate annotation time cost for comparison between groups with using the time recorded during the tests | baseline |
Transfusion Reaction by Washed Red Blood Cell (RBC)

Study Overview
=================
Brief Summary
-----------------
The hypothesis is that transfusion of washed red blood cell can decrease the complication by transfusion.

Conditions
-----------------
Orthopedic Disorder

Intervention / Treatment
-----------------
* Other: Washing of packed RBC by normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing total hip replacement arthroplasty Exclusion Criteria: Patients who do not agree with this clinical study. Patients who have a history of transfusion for recent 1 month. Patients who have rare blood types.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: washed RBC<br>Packed RBCs are Washed and then, transfused. | Other: Washing of packed RBC by normal saline<br> <br> |
| No Intervention: pack RBC<br>Packed RBCs are transfused. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication by transfusion |  | Operation day and during postoperative 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total units of RBC transfused. |  | On the operation day and during the postoperative 5 days | 
| Hemoglobin |  | 1 day before the operation day and postoperative 1 day |
Colombian Screening Mammography Project

Study Overview
=================
Brief Summary
-----------------
A cluster randomized controlled trial was performed in Bogotá, Colombia between 2007-2008 to evaluate the effects of an opportunistic (hospital-based) screening program (intervention) vs. usual care (control) in which 26 clinics were randomized to an intervention (N=13) or control arm (N=13). At intervention clinics general practitioners were instructed to perform clinical breast examination (CBE) on all women aged 50-69 years attending clinics for non-breast health related issues, and to refer them for mammographic screening. Physicians from control clinics were not specifically instructed to perform breast-screening or refer women for mammography, but could do so if they thought it appropriate ('usual care'). Women were followed for 2 years post-randomization.

Official Title
-----------------
Pilot Study for Implementing Breast Cancer Early Detection Programs in Colombia

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

Intervention / Treatment
-----------------
* Other: Opportunistic Breast cancer screening
* Other: Usual Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Aged 50-69 Resident in Bogotá, Colombia or surrounding cities; Had not had a mammogram in the previous two years; No history of breast cancer Attending health-centers for reasons unrelated to breast health Exclusion Criteria: see above

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 69 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br> | Other: Opportunistic Breast cancer screening<br>* Opportunistic breast screening offered to women attending clinics for non-breast health issues<br>|
| Other: Control<br> | Other: Usual Care<br>* No breast screening was explicitly offered to women attending clinics for non-breast health issues, unless the health care provider felt that it was appropriate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast cancer Incidence | Comparing incidence of breast cancer in women randomized to the opportunistic breast screening arm, compared to women in the control arm. | Two years |
First Tacrolimus Dose Trough Level is Better Than CYP3A5 Genotyping in Tacrolimus Dose Prediction

Study Overview
=================
Brief Summary
-----------------
Tacrolimus dose highly varies among Asian kidney transplant recipients. This can be explained by variety of CYP3A5 expression. CYP3A5 genotyping is highly recommended for patients receiving tacrolimus. Here, we assessed the tacrolimus dose prediction by comparing CYP3A5 expression and tacrolimus dosage using tacrolimus concentration after single dose administration prior to kidney transplantation. Plasma tacrolimus trough level was measured at 12 hours after first dose of 0.1 mg/kg of tacrolimus (TacC12), orally administered in 51 new kidney transplant recipients. Patients with CYP3A5 inhibitor/inducer co-medications were excluded. Genotyping for CYP3A5 expression were carried out by RT-PCR. The dosages of tacrolimus at post-operative day 7 and dosage which provided stable therapeutic levels in post-operative month 1 to 3 (C0 5-8 ng/mL) were recorded. The genotyping, TacC12, and target tacrolimus dosage have good correlations.

Official Title
-----------------
First Tacrolimus Dose Trough Level is Better Than CYP3A5 Genotyping in Tacrolimus Dose Prediction

Conditions
-----------------
Kidney Transplantation Recipients

Intervention / Treatment
-----------------
* Drug: Tacrolimus C12


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All KT recipients Exclusion Criteria: Recipient who not receiving tacrolimus

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| All KT recipient<br> | Drug: Tacrolimus C12<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| target tacrolimus dose at 3 months |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of rejection |  | 3-12 months | 
| rate of CNI toxicity |  | 2-12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney transplantation, genotype, tacrolimus, CYP3A5
Post-Marketing Surveillance Study of Micardis® Plus in Patients With Hypertension

Study Overview
=================
Brief Summary
-----------------
Study to evaluate efficacy and tolerability of Micardis® plus under usual daily-practice prescribing-conditions

Official Title
-----------------
Post-Marketing Surveillance Study Micardis® Plus

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Micardis® plus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (Age >= 18 years) males and females for whom a medical antihypertensive therapy is indicated Exclusion Criteria: Age < 18 years

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with hypertension<br> | Drug: Micardis® plus<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in morning blood pressure |  | Baseline, after 6 weeks | 
| Change from baseline in classification of blood pressure | according to Word Health Organisation - Isolated systolic hypertension (WHO-ISH) - definition of 'Deutsche Hochdruckliga' | Baseline, after 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse drug reactions |  | up to 6 weeks | 
| Assessment of efficacy by investigator on 5-point scale |  | after 6 weeks | 
| Assessment of tolerability by investigator on a 5-point scale |  | after 6 weeks | 
| Change from baseline in heart rate |  | Baseline, after 6 weeks |
Real World Evaluation of the Activity and Safety of Fostamatinib in Consecutive Adult Patients With ITP

Study Overview
=================
Brief Summary
-----------------
This is a retrospective and prospective multicenter observational study with the aim to evaluate the real-life use of Fostamatinib in adult patients with chronic ITP, refractory to other treatments.

Detailed Description
-----------------
This is a retrospective and prospective multicenter observational study with the aim to evaluate the real-life use of Fostamatinib in adult patients with chronic ITP, refractory to other treatments. All patients who received at least one dose of Fostamatinib between October 1st, 2021 and April 1st, 2023 outside interventional clinical trials in Italy in the participating centers will be invited to participate in the study. Every patient will be observed for at least 6 months until October 1st, 2023.

Official Title
-----------------
Real World Evaluation Among Italian Centers of the Activity and Safety of Fostamatinib in Consecutive Adult Patients With Immune Thrombocytopenia (ITP)

Conditions
-----------------
ITP - Immune Thrombocytopenia, Chronic ITP, Refractory ITP

Intervention / Treatment
-----------------
* Drug: Fostamatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with chronic ITP who are refractory to other treatments and who received Fostamatinib according to standard clinical practice between October 1st, 2021 and April 1st, 2023 Age greater or equal to 18 years at the treatment start Signed written informed consent document (if feasible) according to ICH/EU/GCP and national local laws Exclusion Criteria: Contraindications or hypersensitivity to Fostamatinib, its active substance or any of its excipients Patients participating in an interventional clinical trial at the time of enrollment.

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 |
| --- | --- |
| Study group<br>All patients being observed during the study duration. | Drug: Fostamatinib<br>* Patients with Chronic ITP, refractory to other treatment who received at least one dose of Fostamatinib outside clinical trials in Italy will be enrolled and observed for at least 6 months.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of ITP patients who receive Fostamatinib | effectiveness evaluation of fostamatinib | 6 months |
Pulmonary Embolism Prognosis Model

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to analyze the clinical manifestations, imaging features, and prognosis-related factors of pulmonary embolism, and to explore the prognosis risk assessment model for Chinese patients

Detailed Description
-----------------
Patients with pulmonary embolism and aged 18 years or older were enrolled in this study.Patient demographic characteristics((age, sex, department, diagnosis, ), basic vital signs, symptoms at their admissions (hemoptysis, dyspnea, chest pain, syncope), laboratory examinations (blood lab routines, blood gas, liver and kidney function, myocardial marker), and imaging examinations (vascular ultrasonography, computed tomographic angiography, echocardiography, chest CT, CTPA, pulmonary perfusion imaging, pulmonary angiography, PET/CT) were collected by reviewing the cases. The prognostic information was collected by telephone follow-up. The follow-up end point was June 2024.

Official Title
-----------------
Observation Study of Clinical Manifestation and Outcome in Chinese Pulmonary Embolism

Conditions
-----------------
Pulmonary Embolism

Intervention / Treatment
-----------------
* Other: observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 years or older. Discharged with the diagnosis of PE from Peking Union Medical College Hospital. Exclusion Criteria: Diagnosed PE by other health care facility or transferred from other health care facility . Without important follow-up data.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: observation|observation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient survival time | Patient survival time after diagnosed as pulmonary embolism | Through study completion, an average of 4 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary Embolism
Effect of NMN Supplementation on Organ System Biology

Study Overview
=================
Brief Summary
-----------------
The goal of this proposal is to determine whether the beneficial effects of NMN on metabolic function observed in rodents applies to people.

Detailed Description
-----------------
This study is looking at the effect of the dietary supplement Nicotinamide mononucleotide (NMN) on key cardiovascular and metabolic functions, specifically those that are important risk factors for diabetes and cardiovascular disease.

Official Title
-----------------
Effect of Nicotinamide Mononucleotide (NMN) Supplementation on Organ System Biology

Conditions
-----------------
Glucose Metabolism Disorders

Intervention / Treatment
-----------------
* Other: Placebo
* Dietary Supplement: Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 25.0-50.0 kg/m² Prediabetes defined as fasting plasma glucose of ≥100 mg/dL, or HbA1C ≥5.7, or HOMA-IR ≥2.5. Exclusion Criteria: Women who are still having menses Persons who take niacin, nicotinamide, or other vitamin B3-related supplementation and are not willing to discontinue supplementation for 3 weeks before medical screening and during the entire study period Persons who consume moderate-large amounts of caffeine daily (>2 cups of coffee or 8 oz caffeinated drinks per day) or consume less amounts of caffeine but believe withdrawal symptoms (e.g. headache) are likely if caffeine is stopped Unstable weight (>3% change during the last 2 months before entering the study)

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>At least 16 weeks of placebo. | Other: Placebo<br>* Intervention will last at least 16 weeks in the form of two capsules.<br>|
| Experimental: NMN supplementation<br>At least 16 weeks of NMN. | Dietary Supplement: Treatment<br>* Intervention will last at least 16 weeks in the form of two or three NMN capsules (total of 300 or 450 mg/day).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Muscle insulin sensitivity | The outcome will be assessed during hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotopic tracer infusion before and after intervention period. | before and after at least 16 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in glucose tolerance | The outcome will be assessed during modified oral glucose tolerance test | before and after at least 16 weeks of treatment |