linjc16/ctgov huggingface dataset:
The Effect of Oral and Intravenous Ramosetron During Laparoscopic Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
Patients undergoing general anesthesia for laparoscopic cholecystectomy have a high risk of postoperative nausea and vomiting (PONV). The investigators investigated the effect of oral and IV ramosetron on PONV prophylaxis after laparoscopic cholecystectomy.

Conditions
-----------------
Nausea, Vomiting, Laparoscopic Cholecystectomy

Intervention / Treatment
-----------------
* Drug: intravenous ramosetron
* Drug: oral ramosetron
* Drug: oral and IV ramosetron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-II patients, 25-65 years, electivelaparoscopic cholecystectomy under general anesthesia Exclusion Criteria: GI disease, pregnant or menstruating, history of motion sickness and/or postoperative emesis, antiemetics within 24 h before surgery

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group I<br>0.3 mg IV ramosetron | Drug: intravenous ramosetron<br>* 0.3 mg IV ramosetron (group I)<br>|
| Active Comparator: group II<br>0.1 mg oral ramosetron | Drug: oral ramosetron<br>* 0.1 mg oral ramosetron (group II)<br>|
| Active Comparator: group III<br>0.1 mg oral ramosetron plus 0.3 mg IV ramosetron | Drug: oral and IV ramosetron<br>* 0.1 mg oral ramosetron plus 0.3 mg IV ramosetron (group III).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of PONV |  | postoperative 0-48 h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oral plus IV ramosetron may be more effective than, IV ramosetron and oral ramosetron for the prophylaxis of, PONV after laparoscopic cholecystectomy
Plasma SARS-CoV-2 RNA Levels in Critically Ill COVID-19 Patients

Study Overview
=================
Brief Summary
-----------------
Retrospective, observationnal study. Evaluation of the association between plasmatic SARS-CoV-2 RNA and day 60 mortality in ICU adult COVID-19 patients.

Official Title
-----------------
Plasma SARS-CoV-2 RNA Levels in Critically Ill COVID-19 Patients (pRNA-COVID-ICU)

Conditions
-----------------
COVID-19 Pneumonia, ARDS Due to Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2

Intervention / Treatment
-----------------
* Diagnostic Test: plasmatic SARS-CoV-2 RNA quantification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age above 18 years in ICU hospitalization COVID-19 related pneumonia confirmed by PCR Exclusion Criteria: plasmatic SARS-COV-2 RNA quantification not available patient's refusal to participate

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: plasmatic SARS-CoV-2 RNA quantification|plasmatic SARS-CoV-2 RNA was quantified by droplet digital PCR|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Day 60 mortality | Association between plasmatic SARS-CoV-2 RNA level and mortality | 60 days |
Descriptive and Risk Factors Analysis of All-cause Postoperative Death in Patients Undergoing Cardiovascular Surgery

Study Overview
=================
Brief Summary
-----------------
The investigators are aimed to develop and externally validate a prediction model of clinical risk factors that quantifies postoperative death after cardiac and vascular surgery. The investigators identify all patients treated with cardiovascular surgery, between 2000 and 2020, within the Wuhan Union hospital and all collaborators. The surgical patient cohort will be matched with the National Death database to determine the patient's postoperative death data. 60% patients were randomly selected to the development cohort. Logistic regression analysis for prediction of postoperative death adjusted for different covariates. The model was externally validated in the remaining 40% patients.

Official Title
-----------------
Descriptive and Risk Factors Analysis of All-cause Postoperative Death in Patients Undergoing Cardiovascular Surgery

Conditions
-----------------
Postoperative Death

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients Undergoing Cardiovascular Surgery Exclusion Criteria: Patients with incomplete electronic medical record information
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 |
| --- | --- | --- |
| Postoperative Death |  | The mortality within 5 years after the cardiovascular surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postoperative death, Cardiovascular surgery, Prediction model
Phase IIa Venous Thromboembolism (VTE) Prevention Study In Total Knee Replacement (TKR)

Study Overview
=================
Brief Summary
-----------------
This study was designed to assess the safety and efficacy of GW813893 in the prophylaxis of VTE following TKR and to provide evidence to enable the selection of the appropriate dose(s) and dose regimen of GW813893 for future investigation.

Official Title
-----------------
Dose Ranging Trial for the Evaluation of the Safety and Efficacy of GW813893 in the Prophylaxis of Venous Thromboembolism Post Total Knee Replacement Surgery.

Conditions
-----------------
Venous Thromboembolism

Intervention / Treatment
-----------------
* Drug: GW813893


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients who are scheduled for primary elective unilateral total knee arthroplasty. Exclusion criteria: Women who are not surgically sterile or post-menopausal Have a contra-indication to contract venography Have a known disorder associated with increased risk of bleeding or have been immobile up to 12 weeks before surgery.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GW813893|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of death OR symptomatic or non-symptomatic blood clots in the legs OR symptomatic blood clots in the lungs within 7 +/- 2 days following total knee replacement surgery. |  | symptomatic blood clots in the lungs within 7 +/- 2 days following total knee replacement surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of bleeding within 7 +/- 2 days following total knee replacement surgery. |  | Incidence of bleeding within 7 +/- 2 days following total knee replacement surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anti-thrombolytic direct Factor Xa inhibitor
Ovarian Malignancy Incidence in Moderate Risk Women With Low CA 125

Study Overview
=================
Brief Summary
-----------------
The investigators are assessing the incidence of ovarian cancer in premenopausal women who were at moderate risk of malignancy with low CA125.

Detailed Description
-----------------
About 10% of premenopausal women may have a surgery for ovarian masses. In premenopausal women the incidence of ovarian malignancy is 1:1000 in case of symptomatic ovarian cyst.1 CA125 is unreliable in differentiating benign from malignant ovarian mass in premenopausal women due to many false positive results and reduced specificity.1 pelvic vaginal ultrasonography is the most effective tool in evaluating ovarian masses due to increased sensitivity over abdominal US.1 An estimation of risk of malignancy index is essential in evaluating an ovarian mass.26 /2 Risk of malignancy index combines presurgical features serum including CA125, menopausal status and ultrasound findings. RMI=Ux Mx CA125 in which each feature takes a score and after calculation score less than 25 is mild, from 25-250 moderate and more than 250 has a severe risk of malignancy needing oncologist.44/3

Official Title
-----------------
Ovarian Malignancy Incidence in Premenopausal Women Who Were at Moderate Risk for Malignancy by Risk of Malignancy Index With Low CA 125.(Retrospective Study)

Conditions
-----------------
Ovarian Cancer

Intervention / Treatment
-----------------
* Other: Risk of malignancy index


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with complex ovarian cyst Abdominal pain Menometrorrhagia Exclusion Criteria: Significant weight loss Cachexia History of ovarian or other malignancy Family history of ovarian Cancer

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| premenopausal women<br>premenopausal women with complex ovarian mass moderate for malignancy by risk of malignancy index score and low CA125. | Other: Risk of malignancy index<br>* Calculation of RMI before sugery.<br>* Other names: RMI;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of ovarian malignancy | Calculation of number of women who had ovarian cancer after an operation in moderate risk | one year |
Endoscopic Treatment for Isolated, Single Suture Craniosynostosis

Study Overview
=================
Brief Summary
-----------------
This is a prospective study to evaluate outcomes in patients undergoing endoscopic craniectomy for isolated, single-suture craniosynostosis.

Official Title
-----------------
Endoscopic Treatment for Isolated, Single Suture Craniosynostosis

Conditions
-----------------
Craniosynostosis

Intervention / Treatment
-----------------
* Procedure: Endoscopic strip craniectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants 1 to 6 months of age with isolated, single-suture craniosynostosis. Exclusion Criteria: Multiple suture craniosynostosis and infants older than 6 months of age.

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 6 Months

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 |
| --- | --- |
| Sagittal synostosis<br>Male and female infants from 1-6 months of age with isolated, single suture sagittal craniosynostosis. | Procedure: Endoscopic strip craniectomy<br>* Surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endoscopic, craniosynostosis, sagittal, synostosis
Fibrinogen as a Surrogate for Global Haemostasis in Plasma Exchange

Study Overview
=================
Brief Summary
-----------------
Plasma exchange is a frequently used therapy in many antibody-mediated disorders, such as humoral rejection after kidney transplantation. Treatment frequency is adjusted to daily measured fibrinogen blood levels to prevent bleeding complications. However, data about the correlation of fibrinogen blood levels and function of the coagulation system during plasma exchange therapy is scarce. In the present study we examine blood fibrinogen levels and coagulation factors as well as thrombin clotting time in patients under plasma exchange therapy.

Official Title
-----------------
Observational Study of Fibrinogen as a Surrogate for Global Haemostasis in Plasma Exchange Therapy

Conditions
-----------------
Clotting Disorder Due to Plasma Exchange Therapy, Humoral Rejection After Kidney Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: plasma exchange therapy due to humoral rejection after kidney transplantation Exclusion Criteria: hereditary coagulopathy chronic liver disease (Child C) therapeutic anticoagulation malnutrition (BMI<17.5)

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 |
| --- | --- |
| Humoral rejection, TPE<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thrombin clotting time | Daily measurement after initiation of plasma exchange therapy until treatment course is finished | Baseline, daily measurement until hospital discharge (avarage hospital stay: 10 days) |
Institutional Registry of Hip Fracture in the Elderly

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to create an institutional and population-based registry of Hip fracture in the elderly with a prospective survey based on epidemiological data, risk factors, diagnosis, prognosis, treatment, monitoring and survival.

Detailed Description
-----------------
All patients over 65 years old who are admitted to the orthopedic and traumatology ward diagnosed with hip fracture will be assessed. The generation of the list of potentially evaluable patients will be performed daily. Once defined patient inclusion, an intern take oral informed consent and will proceed to complete the CRF. Cohort will be followed at 3 months and a second follow-up at year. Variables to be measured: Patient Data Comorbidities Charlson score Scales functionality Factors prior to the fall Medications Trauma variables Complications Mortality

Official Title
-----------------
Institutional Registry of Hip Fracture in the Elderly

Conditions
-----------------
Hip Fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 65 with hip fracture. Admission to HIBA Followed by any health care provider. - Exclusion Criteria: 1 Patient refuses to participate in the registration or informed consent process -

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| hip fracture<br>aged >65 with hip fracture | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frailty (measured by the Rockwood Scale) | It will performed once included in the Register the Rockwood Scale of Frailty and year follow-up after. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hip fracture, elderly
A Short-Term Study to Examine the Effects of ATHX-105 Phosphate on Weight Loss and Safety

Study Overview
=================
Brief Summary
-----------------
This primary purpose of this study is to determine if ATHX-105 phosphate causes weight loss over a 12-week period.

Detailed Description
-----------------
The rate of obesity in adults continues to increase. Obesity affects overall health and is associated with an increased risk for diabetes, high blood pressure, coronary artery disease, osteoarthritis, and sleep apnea. To date, the medication options to treat obesity have been limited. This study will examine if a new investigational drug, ATHX-105 phosphate, may cause weight loss in humans over a 12-week period.

Official Title
-----------------
Double-Blind, Randomized, Placebo-Controlled, 12-Week Study of the Safety and Efficacy of ATHX-105 Phosphate for the Treatment of Obesity

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

Intervention / Treatment
-----------------
* Drug: ATHX-105 phosphate
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obese adults with a body mass index of 30-45 kg/m2 Exclusion Criteria: Pregnancy Diabetes Adults with serious or unstable current or past medical conditions

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: Placebo<br>* includes diet, physical activity, and lifestyle modification<br>|
| Experimental: 2<br> | Drug: ATHX-105 phosphate<br>* includes diet, physical activity, and lifestyle modification<br>|
| Experimental: 3<br> | Drug: ATHX-105 phosphate<br>* includes diet, physical activity, and lifestyle modification<br>|
| Experimental: 4<br> | Drug: ATHX-105 phosphate<br>* includes diet, physical activity, and lifestyle modification<br>|
| Experimental: 5<br> | Drug: ATHX-105 phosphate<br>* includes diet, physical activity, and lifestyle modification<br>|
| Experimental: 6<br> | Drug: ATHX-105 phosphate<br>* includes diet, physical activity, and lifestyle modification<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vital signs, lipids/glucose, waist circumference |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Weight loss, Weight-loss drugs, Obesity, Overweight, Body weight, Diet, Metabolic Disorder, Nutrition Disorder
Stratification of Oral Ulcers in Rheumatoid Arthritis Patients Kept on Methotrexate

Study Overview
=================
Brief Summary
-----------------
This study included rheumatoid arthritis patients receiving Methotrexate as monotherapy. All eligible patients were subjected to thorough clinical examination and full history to identify oral events. Drug history, current dose and duration of MTX were recorded.

Detailed Description
-----------------
The current study was conducted in the Clinics of Oral Medicine, Faculty of Dentistry and Rheumatology, Faculty of Medicine - Cairo University from 2017 to 2019. This study followed the principles of the Helsinki Declaration and was approved by the Research ethics committee of Faculty of Dentistry, Cairo University. RA patients receiving MTX as monotherapy were included in the study. Patients suffering from systemic disease known to cause oral manifestations; salivary gland diseases and malignancies were excluded. All eligible patients were subjected to thorough clinical examination for the whole oral cavity. Medical history and history of any oral manifestation were recorded. Drug history, dose, and duration of MTX were recorded. Categorical data was presented as frequencies and percentages. Continuous data was described as means and standard deviations. Means were compared by one-way ANNOVA and Student-t-test. The significance level was set at P ≤0.05. Statistical analysis was performed with IBM® SPSS® Statistics Version 25 for Windows.

Official Title
-----------------
Stratification of Oral Lesions in Methotrexate-treated Rheumatoid Arthritis Patients

Conditions
-----------------
Methotrexate Adverse Reaction, Oral Mucositis

Intervention / Treatment
-----------------
* Other: questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with Rheumatoid arthritis using methotrexate as sole treatment Exclusion Criteria: patients with Rheumatoid arthritis using any other treatments for Rheumatoid arthritis
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 of Rheumatoid arthritis patients<br>RA patients receiving MTX as monotherapy were included in the study. Patients suffering from systemic disease known to cause oral manifestations; salivary gland diseases and malignancies were excluded. | Other: questionnaire<br>* conventional intra-oral examination and questionnaire<br>* Other names: intra-oral examination;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of oral mucositis | Clinical examination (intra-oral) and history of oral mucositis where recorded | throughout the study time (one year) |