linjc16/ctgov huggingface dataset:
A Prospective Study of Post-operative Opioid Use in General Surgery Patients

Study Overview
=================
Brief Summary
-----------------
Patients undergoing approximately 10 common outpatient general surgical operations will be given a narcotic prescription for a specified number of pills. Inpatients who are about to be discharged after surgery or trauma will be given narcotic prescriptions for a specified number of pills. Patients will be given a patient report form which they will use to record the number of pills they take each day and their daily pain score on a scale of 0-10.

Official Title
-----------------
A Prospective Study of Post-operative Opioid Use in General Surgical Patients

Conditions
-----------------
Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >= 18 years of age undergoing one of 9 elective outpatient operations: partial mastectomy, partial mastectomy and sentinel node biopsy, melanoma wide excision and sentinel node excision, thyroidectomy, parathyroidectomy, open inguinal hernia repair, laparoscopic inguinal hernia repair, laparoscopic cholecystectomy OR an inpatient on the general surgery service who took at least one oral narcotic Exclusion Criteria: allergic to all narcotics chronic opioid use history of opioid or benzodiazepine abuse

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 |
| --- | --- |
| Outpatient general surgery operation<br>Patients undergoing outpatient general surgical operations They will be given a specified number of narcotic pills based on our retrospective analysis of patient post-operative opioid use | |
| Inpatient general surgical patients<br>Inpatients who are being discharged They will be given a specified number of narcotic pills based on the number of pills they took in the 24 hrs prior to discharge | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of pills to satisfy 80% of patients opioid needs |  | 1 yr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patients requiring narcotic refills when specified number of pills is given |  | 1 year | 
| patient pain level, daily |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
post-operative pain
Enteral Formula Tolerance of Standard Tube Feedings

Study Overview
=================
Brief Summary
-----------------
This prospective observational study seeks to assess ability to achieve enteral feeding goals with standard tube feeding formulas.

Conditions
-----------------
Enteral Feeding

Intervention / Treatment
-----------------
* Other: enteral formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18 years of age Currently tolerating enteral feeding Has enteral access Requires enteral tube feeding to provide 90% or more of their nutritional needs (without the use of modular(s)) for at least 21 days Having obtained his/her and/or his/her legal representative's informed consent. Exclusion Criteria: Condition which contraindicates enteral feeding (i.e. intestinal obstruction) Lack of enteral access Any condition that would contraindicate use of the study product (i.e. need for severe fluid restriction, cow's milk protein allergy, other) Currently participating in another conflicting clinical study that would interfere with anticipated endpoints Judged to be at risk for poor compliance to the study protocol. Lack of 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 |
| --- | --- |
| enterally fed adults<br>adult subjects with established enteral access receiving standard tube feeding formula | Other: enteral formula<br>* standard tube feeding formulas<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily percentage of caloric nutritional goal met |  | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily percentage of protein goal met |  | 21 days | 
| GI tolerance |  | 21 days | 
| Adverse events and serious adverse events |  | 21 days |
Ultrasound Three-dimensional Characterization of Ovarian Morphology in Women With Polycystic Ovary Syndrome (PCOS)

Study Overview
=================
Brief Summary
-----------------
Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders occurring in women of reproductive age. PCOS is considered a syndrome of ovarian dysfunction that is characterized by the heterogeneous clinical manifestation of infrequent or absent menstrual cycles, hyperandrogenism, and polycystic ovarian morphology. An important ultrasound parameter is the ratio stroma/ovary, the ratio of the volume, evaluated in two-dimensional ultrasound, of the stroma, that secrete androgen, and the ovary. It has been shown that when this ratio is higher than a third the levels of circulating androgens and high. Aim of the present study is to assess whether this ratio, determined with three-dimensional ultrasound, is correlated to the increase of androgens.

Conditions
-----------------
PCOS, Hyperandrogenism

Intervention / Treatment
-----------------
* Procedure: Ultrasound
* Procedure: Determination of concentrations of androgens
* Device: Three dimensional ultrasound probe


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Self-reported history of infrequent or absent menstrual cycles and/or PCOS ultrasound feature and/or clinical or biochemical hyperandrogenism Did not take hormonal contraception, fertility therapies, or insulin sensitizers in the three months prior to enrollment Exclusion Criteria: Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 25 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PCOS women<br> | Procedure: Ultrasound<br>* The patients will be subjected to ultrasound bi-dimensional or three-dimensional. Will Be calculated the ratio stroma/volume with both methods<br>* Other names: Ultrasound evaluation of ovarian morphology;Procedure: Determination of concentrations of androgens<br>* Determination of concentrations of serum levels of circulating androgens<br>Device: Three dimensional ultrasound probe<br>* Capture of ovarian three dimensional volumes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Androgens serum levels in women with ultrasound morphological PCO |  | up to 1 year |
Safety and Efficacy of Medical Abortion Provided by Midlevel Providers or Physicians

Study Overview
=================
Brief Summary
-----------------
The physical examination before an abortion is usually performed by a physician. However, in many countries access to physicians is limited. To increase access to safe abortion this study wishes to examine if midlevel providers such as specially trained midwives can provide safe abortion services. Midwives in study were specially trained to perform early pregnancy ultrasound and if needed to consult a physician. The midwife then provided the abortion service as well as the contraceptive advice. Women were randomized to receive the service from a midwife or a physician.

Official Title
-----------------
Safety and Efficacy of Medical Abortion Provided by Midlevel Providers or Physicians

Conditions
-----------------
Medical Abortion

Intervention / Treatment
-----------------
* Other: Midwife


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy women aged 18-45 with no contraindication to medical abortion Exclusion Criteria: any medical condition which contraindicates medical abortion

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: midwife<br>Gynecological exam and ultrasound performed by midwife, medical abortion service provided by midwife,contraceptive advice provided by midwife. Follow-up visit provided by midwife | Other: Midwife<br>* gynecological exam and ultrasound and contraceptive advice provided by midwife<br>|
| No Intervention: Physician<br>Gynecological exam and ultrasound and contraceptive advice provided by physician. Medical abortion service and follow-up visit provided by midwife | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feasibility | Successful completion of abortion without need for unscheduled visits or calls. | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy | complete uterine evacuation without the need for further medical or surgical intervention | 3 weeks | 
| acceptability | as assessed by questionnaire | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
abortion, medical abortion
Establishing Automatic Method of Counting and Classify Bone Marrow and Peripheral Blood Cells

Study Overview
=================
Brief Summary
-----------------
Counting and classification of blood cells in a bone marrow smear and peripheral blood smear are essential to clinical hematology. To this date, this procedure has been carried out in a manual manner in the great majority of clinical settings. There is often inconsistency in the counting result between different operators largely due to its manual nature. There has not been an effective and standard method for blood smear preparation and automatic counting and classification. The recent advent of deep neural network for medical image processing introduced new opportunities for an effective solution of this long-standing problem. Numerous results have been published on the effectiveness of convolutional neural network in clinical image recognition task.

Official Title
-----------------
Establishing Automatic Method of Counting and Classify Bone Marrow and Peripheral Blood Cells

Conditions
-----------------
Hematologic Diseases, Artificial Intelligence, Acute Leukemia

Intervention / Treatment
-----------------
* Other: there are not any interventions in this study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have suspected or confirmed hematological diseases and receive bone marrow or peripheral blood cell morphological examination in National Taiwan University Cancer Center Patients who are aged more than 20 y/o Exclusion Criteria: •Patients who are not willing to sign informed consents

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: there are not any interventions in this study|there are not any interventions in this study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the accuracy of cell counting and classifying between automatic method and manual method through digital microscopic photos of bone marrow smear and peripheral blood smear using deep convolutional neural networks |  | 3 years |
Evaluation of Adherence to Clinical Treatment of Glaucoma

Study Overview
=================
Brief Summary
-----------------
Evaluation of adherence to clinical treatment of glaucoma in patients of a Reference Ophthalmological Hospital in Goiânia using Morisky Adhesion scale as a validated questionary.

Official Title
-----------------
Evaluation of Adherence to Clinical Treatment of Glaucoma in Patients of a Reference Ophthalmological Hospital in Goiânia

Conditions
-----------------
Glaucoma; Drugs

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: have glaucoma diagnosed - Exclusion Criteria: not having glaucoma diagnosed -

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 100 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 |
| --- | --- | --- |
| Evaluation of adherence to clinical treatment of glaucoma in patients of a Reference Ophthalmological Hospital in Goiânia | evaluation of the scale | 2 months |
The Drug-Drug Interaction of SHR4640 and Febuxostat in Patients With Hyperuricemia

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to assess the pharmacodynamic properties of drug-drug of SHR4640 and Febuxostat interaction in patients with Hyperuricemia.

Official Title
-----------------
A Phase I, Single-Center, Open-Label Study to Evaluate Pharmacodynamics of Drug-Drug Interaction Between SHR4640 and Febuxostat in Patients With Hyperuricemia

Conditions
-----------------
Hyperuricemia

Intervention / Treatment
-----------------
* Drug: SHR4640 dose1
* Drug: Febuxostat dose2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has a body mass index ≥18 and ≤30 kg/m2; Screening sUA value ≥8mg/dl; Subject has no clinically relevant abnormalities in vital signs, ECG, physical examination，imaging examination or safety laboratory values. Exclusion Criteria: Subject known or suspected of being sensitive to the study drugs or its ingredient； ALT、AST、TBIL>ULN; History of kidney stones or screening kidney stones by B-ultrasound； History of malignancy； History of xanthinuria； Donated blood（≥400ml）within 3 months prior to screening or received transfusion of blood。

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHR4640<br>SHR4640 dose1 Oral Tablet Day1 Day14 qd,Febuxostat dose2 Oral Tablet Day8 and Day14 qd. | Drug: SHR4640 dose1<br>* Tablet,dose1,QD<br>Drug: Febuxostat dose2<br>* Tablet,dose2,QD<br>|
| Experimental: Febuxostat<br>Febuxostat dose2 Oral Tablet Day1 and Day14 qd, SHR4640 dose1 Oral Tablet Day8 Day14 qd. | Drug: SHR4640 dose1<br>* Tablet,dose1,QD<br>Drug: Febuxostat dose2<br>* Tablet,dose2,QD<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) of SHR4640 and Febuxostat from plasma |  | Day1 to Day 14 | 
| Area under the plasma concentration versus time curve (AUC) of SHR4640 and Febuxostat from plasma |  | Day1 to Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apparent terminal half-life (t1/2) of SHR4640 and Febuxostat from plasma |  | Day1 to Day 14 | 
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events | Laboratory indicators, 12-lead electrocardiogram (ECG), physical examination,vital signs, adverse events (NCI-CTC AE 5.0), etc. | Clinical significant changes from Day-21 up to Day 29 |
Collection of Human Tissue Samples From the Neck Region for Characterization of Its Molecular and Biochemical Signatures

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to gather tissue (from the neck region), specimens (blood and urine) and medical record data from many patients and store them in one place so that scientists have the information they need to conduct research and learn about new ways to predict, identify and treat illness, specifically those related to obesity and diabetes.

Detailed Description
-----------------
This protocol is designed to actively collect biospecimens (specifically, tissue from the neck region) and clinical data for donation to the TRI-MD, specifically, Dr. Sparks' laboratory. These specimens and data will be available to Dr. Sparks for future research activity in accordance with the Florida Hospital and Translational Research Institute for Metabolism and Diabetes (TRI) policies.

Official Title
-----------------
Collection of Human Tissue Samples From the Neck Region for Characterization of Its Molecular and Biochemical Signatures

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Procedure: Adults presenting for surgery in the neck area


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults aged 18 and older presenting for surgery in the neck area Able to provide informed consent Exclusion Criteria: Unable to provide informed consent

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adults presenting for surgery in the neck area<br> | Procedure: Adults presenting for surgery in the neck area<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of brown adipose neck tissue | Any tissue deemed suitable by the surgeon and/or the research team during the neck surgery for the study's research objectives will be removed and collected for donation to this protocol. When there is enough tissue available, half will be snap frozen for extraction of DNA, RNA and protein. The other half will be cryopreserved for the future production of viable cells. When there is not enough tissue, the person collecting the samples will determine the processing. For research purposes, we aim to collect up to 500mg of each tissue. | Day of scheduled surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Brown adipose tissue, Neck surgery
Low Dose Cyclophosphamide Treats Genital Warts

Study Overview
=================
Brief Summary
-----------------
Condylomata acuminata (CA) caused by human papillomavirus (HPV) is a common sexually transmitted disease with half a million new cases diagnosed in the United States per year. Recurrence is a major challenge for CA treatment. The investigators have demonstrated that FOXP3+ regulatory T (Treg) cells mediate the immunosuppression in large genital warts. And low-dose cyclophosphamide (CY), a conventional chemotherapy drug, has been reported to selectively deplete Treg cells in cancer patients. Therefore, the investigators hypothesized that low-dose CY can be used to treat genital warts. In this study, 104 CA patients have been recruited for clinical trial with a 1:2 randomization. Among them, 64 patients received low-dose cyclophosphamide and 32 received placebo. In 8 extra patients, high-dose cyclophosphamide was given.

Detailed Description
-----------------
Patients were first treated with CO2 laser therapy, and then treated with low-dose CY, orally 50 mg per day for 7 days.The CA recurrence were observed.

Official Title
-----------------
Phase III Study of the Treatment of Genital Warts by Low Dose Cyclophosphamide

Conditions
-----------------
Genital Wart

Intervention / Treatment
-----------------
* Drug: cyclophosphamide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of large genital warts Exclusion Criteria: HPV type 6 or 11 was detected negatively by PCR method.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: placebo<br> | |
| Active Comparator: cyclophosphamide<br> | Drug: cyclophosphamide<br>* 50 mg oral per day for 7 days<br>* Other names: CY;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| low-dose cyclophosphamide effectively prevents the recurrence of large genital warts after laser therapy |  | 6 month |