linjc16/ctgov huggingface dataset:
Retrospective Study in Patients Who Have Had a Difficult Intubation.

Study Overview
=================
Brief Summary
-----------------
The investigator wants to investigate if there is an increased risk of postoperative pulmonary problems in patients who have had an intubation where there was need for more than a laryngoscope.

Detailed Description
-----------------
A difficult intubation is defined as an intubation in which more than a laryngoscope was needed. Afterwards patient data retrieved from the Clinical Work Station: age, type of operation and time, date, type of anaesthesia, de tools needed for intubation, time needed for intubation and anaesthesia. In the Clinical Work Station of the Hospital the investigator will search for the following data in these selected patients: preoperative comorbidities, home medication, type of postoperative pulmonary problems and the treatment that was given, time of hospital stay and which department the patient stayed. Patients with a difficult intubation will be linked to a patient with a corresponding medical history and type of operation but without a difficult intubation. The investigator will look for the same parameters of these patients in the Clinical Work Station. By means of an odds-ratio the relative risk of a pulmonary complication after a difficult intubation in connection with an easy intubation with different variables can be calculated.

Official Title
-----------------
Retrospective Study of the Risk of Aspiration and Postoperative Pulmonary Problems in Patients Who Have Had a Difficult Intubation.

Conditions
-----------------
Aspiration, Pneumonia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Every patient who had an intubation where another device than a laryngoscope was necessary Exclusion Criteria: N/A
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| with difficult intubation<br>Control population | |
| without difficult intubation<br>Control population | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative risk for postoperative pulmonary incidents | number of participants with Relative risk | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Risk on aspiration, Postoperative, Difficult Intubation
A Retrospective Study With Prospective Follow-Up of Laparoscopic Ventral Hernia Repair Utilizing the Bard Sepramesh IP Composite

Study Overview
=================
Brief Summary
-----------------
This study will enroll subjects who underwent a laparoscopic ventral hernia repair utilizing Sepramesh at least 12 months before starting in this study. The consented subjects' medical records will be reviewed for evidence of any risk factors of hernia recurrence, procedure time, complications and any documented recurrences. The subjects will be asked to undergo a physical exam to rule out any recurrences that were not documented in the medical records.

Official Title
-----------------
A Single Arm, Single-Center, Retrospective Study With Prospective Follow-Up of Laparoscopic Ventral Hernia Repair Utilizing the Bard Sepramesh IP Composite

Conditions
-----------------
Hernia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have undergone a laparoscopic ventral repair utilizing Sepramesh at least 12 months before starting in this study. Have signed an Informed Consent Form (ICF). Exclusion Criteria: Underwent implantation of Sepramesh for any reason other than ventral hernia repair.

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 |
| --- | --- |
| Sepramesh Group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hernia Recurrence Rate of Hernias Post Repair With Sepramesh. | A recurrent hernia is a hernia, confirmed by the Investigator at any point after the surgery, in the same location as the hernia repaired in the index procedure. | 12 months or greater (average follow-up time of 3 years; range 13-65 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications in Subjects With Hernias Repaired With Sepramesh. | Complications will be assessed by evaluation of the procedural and device related adverse events (AEs) documented in the subject's medical files from the time surgery was initiated until the day the subject had a postoperative visit (that is, the protocol specified postoperative visit for conducting a physical examination). | 12 months or greater (average follow-up time of 3 years; range 13-65 months) | 
| Procedural Time for Sepramesh Placement. | Procedure time will be defined as beginning when the Investigator made the initial incision and ending when the skin closure was completed (skin to skin). | Day 0 | 
| Recovery Time Associated With Hernias Repaired With Sepramesh. | Recovery time will be defined as the time it took for the subject to return to work. | 12 months or greater (average follow-up time of 3 years; range 13-65 months) |
Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
Pivotal Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma

Official Title
-----------------
A Single-arm, Multicenter, Open, Pivotal Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma

Conditions
-----------------
Hepatocellular Carcinoma Non-resectable

Intervention / Treatment
-----------------
* Device: UNI-DEB


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 19 years Diagnosis of HCC Unresectable asymtomatic uninodular or multinodular tumor. Subject who maintain clinically normal hepatopetal flow without main portal vein closure At least one measurable target lesion by CT or MRI which 10 mm or more and 100 mm or less. ECOG Performance Status of 0 or 1. Child-Pugh class A or B Life expectancy of at least 6 months. Exclusion Criteria: Another primary tumour, with the exception of conventional basal cell carcinoma or superficial bladder neoplasia Hepatic resection, liver transplantation or Percutaneous local treatment Previously received HCC related medical procedure Previously treated with anthracyclines Only measurable disease is within an area of the liver previously subjected to radiotherapy. Child Pugh C Active gastrointestinal bleeding within 6 months from screening. Total bilirubin > 3mg/dL WBC < 3,000cells/mm3 Platelet < 50,000mm3 Serum creatinine > 2mg/dL INR> 1.4 ALT and AST > 5 times UNL Diffuse HCC defined as >50% tumour involvement of the whole liver.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UNI-DEB<br> | Device: UNI-DEB<br>* Applicate the TACE with UNI-DEB to unresectable hepatocellular carcinoma patient<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate by independent evaluator |  | 4 weeks after treatment |
Factors Associated With the Complexity of Dental Implant Surgery After Alveolar Ridge Preservation: A Retrospective Cross-sectional Study

Study Overview
=================
Brief Summary
-----------------
Alcohol consumption, tooth position, and periodontitis-related tooth extraction affect the complexity of subsequent implant surgery after alveolar ridge preservation.

Detailed Description
-----------------
Materials and methods We retrospectively analyzed the dentition of 165 alveolar ridge preservation sites in 116 patients. The bone width at three different vertical levels was measured on cone beam computed tomography images, and a comparison of bone regeneration requirements for subsequent dental implant surgery was performed for different socket types.

Official Title
-----------------
Attending Physician, Division of Periodontics, Department of Dentistry, Kaohsiung Medical University Hospital, Kaohsiung

Conditions
-----------------
the Complexity of Implant Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: teeth extraction in the premolar and molar regions, who underwent flapless tooth extraction with alveolat ridge preservation (ARP) and filling with freeze-dried bone allograft (FDBA) and platelet-rich fibrin (PRF), who underwent cone beam computed tomography (CBCT) followed by dental implant surgery after tooth extraction, and with adequate oral hygiene Exclusion Criteria: untreated periodontitis, systemic disease, or the of medication that influences bone metabolism

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

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

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 |
| --- | --- | --- |
| Alveolar bone width |  | 4 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
periodontitis, alveolar ridge preservation, implant surgery.
Bioequivalency Study of Zaleplon 10 mg Capsules Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to show the bioequivalence of a Roxane Laboratories' Zaleplon Capsules, 10 mg, to Sonata ® Capsules, 10 mg (Jones Pharma) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design

Official Title
-----------------
A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of Zaleplon 10 mg Capsules Under Fasting Conditions.

Conditions
-----------------
Short Term Treatment of Insomnia

Intervention / Treatment
-----------------
* Drug: Zaleplon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to Zaleplon or any comparable or similar product.

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence |  | Baseline, Two Period, Seven day washout |
A Study of Vaginal MicroFlora and Immune Profiles of Patients With Recurrent Urinary Tract Infection

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the extent to which vaginal microflora and immune profiles of patients with urinary tract infection (UTI) differ from healthy controls.

Detailed Description
-----------------
Recurrent urinary tract infections, which occur mostly in the female population, can be potentially harmful if not treated and significantly reduce quality of life. By characterizing the vaginal microflora and immune profiles of women that suffer recurrent UTIs in contrast to a healthy age matched normal group of women (with no history of recurrent UTIs), we can better understand the differences. This in turn can lead to development of better quality probiotics that will be based on their scientific basis, clinical efficacy, and quality in terms of shelf life and delivery to target sites. The reduction in only one third of UTI cases seen each year would have a significant impact on reducing health care costs.

Official Title
-----------------
A Study of Vaginal MicroFlora and Immune Profiles of Patients With Recurrent Urinary Tract Infection

Conditions
-----------------
Urinary Tract Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion Criteria for UTI Group: At least 2 recurrent UTIs within the last year Written informed consent Inclusion Criteria for Normal Group: No UTI within the past 5 years Written informed consent Exclusion Criteria: Exclusion Criteria for Both Groups: Active UTI Urinary tract anomalies Evidence of a neurogenic bladder Known immunodeficiencies Use of antibiotics, within the last month Concomitant use of oral steroids Known renal calculi Previous or ongoing chemotherapy Pregnancy

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Recurrent UTI<br> | |
| Healthy controls<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Effect of Estrogen and Progesterone Levels on Knee and Ankle Joint Laxity

Study Overview
=================
Brief Summary
-----------------
The proposed research is an observational study designed to compare estrogen and progesterone serum levels with knee and ankle joint laxity, and muscle reaction time as a measure of neuromuscular function. Three groups of women athletes with differing estrogen and progesterone profiles (normal menstrual cycles, amenorrheic, and exogenous estrogen supplementation) and one control group (male collegiate athletes) will be used to compare differences in joint laxity and neuromuscular function. Blood levels of estrogen and progesterone will be measured at four time points across the menstrual cycle. Joint laxity and muscle reaction time will also be measured at each of these points. The investigator hypothesizes that knee and ankle joint laxity and muscle reaction time will significantly increase with increasing estrogen and progesterone levels.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pre-collegiate or collegiate athletes

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 23 Years

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Joint Instability
Uptake of the Antifungal Miconazole and Effect on Estrogen Metabolizing Enzymes in Humans

Study Overview
=================
Brief Summary
-----------------
The purpose of this study, is to study the uptake of the pharmaceutical antifungal miconazole when used as a vaginal suppository in young women. The investigators want to know if the uptake is big enough to cause a biological effect (effect on CYP1A2 and CYP3A4 activity).

Official Title
-----------------
Uptake of the Antifungal Miconazole and Effect on Estrogen Metabolizing Enzymes in Humans

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

Intervention / Treatment
-----------------
* Drug: Brentan (miconazole)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Woman Age 18-45 years Healthy Signed consent Written authority to the GCP-unit Exclusion Criteria: Pregnancy Breast-feeding Hypersensitivity to miconazole Hypersensitivity to sodium ethyl parahydroxybenzoic acid(E219) Hypersensitivity to sodium propyl parahydroxybenzoic acid (E217) Using contraceptives with hormones Daily consumption of alcohol Daily use of medicine Participated in a clinical trial within the last 3 months

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Brentan (miconazole)|Vaginal suppository 1200 mg at day 6|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CYP1A2 and CYP3A4 activity measured as metabolite ratios of caffeine and quinidine, respectively |  | urine and blood collected day 4 and 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of miconazole or metabolites in blood and urine |  | Blood and urine collected day 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Miconazole, CYP1A2, CYP3A4, Women, Healthy Subjects
Trans-cerebellar Diameter and Placental Thickness in Third Trimesteric Pregnant Women for Calculation of Gestational Age

Study Overview
=================
Brief Summary
-----------------
Pregnant women at 32-36 weeks gestational age with sure gestational dating (based in both last menstrual period and dating ultrasound) and otherwise normal singleton pregnancy will be recruited. Ultrasonographic estimation of gestational age using combined transcerebellar diameter and placental thickness will be compared to the actual estimated gestational age.

Official Title
-----------------
Accuracy of Trans-cerebellar Diameter and Placental Thickness in Third Trimesteric Pregnant Women for Calculation of Gestational Age: Prospective Study

Conditions
-----------------
Gestational Age and Weight Conditions

Intervention / Treatment
-----------------
* Diagnostic Test: Transcerebellar diamater
* Diagnostic Test: Placental thickness


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sure of dates Have dating ultrasound with crown rump length between (9 to 12 )weeks No hormonal contraception 3 months before conception. Regular menstrual cycles. Medically free. Single pregnancy Gestational age 32-36 weeks Exclusion Criteria: Irregular menstrual cycles and not sure of dates Multiple pregnancy. Fetal anomalies. Placenta previa, placental anomalies and poor visualization of the placenta Fetal growth restriction Pregnant women with medical disorder e.g. diabetes mellitus, Pre-eclampsia, Systemic lupus erythromatosis, hypertension.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 39 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 |
| --- | --- |
| Pregnant women at 32-36 weeks gestational age<br>Pregnant women at 32-36 weeks gestational age with sure dates and crown-rump length dating ultrasound | Diagnostic Test: Transcerebellar diamater<br>* Using SAMSUNG H60 convex probe 2-8 MHz Machine by the same sonographer, trans-cerebellar diameter is identified by obtaining an oblique view through posterior fossa that included visualization of midline thalamus, cerebellar hemispheres and cisterna magna.<br>Diagnostic Test: Placental thickness<br>* Using SAMSUNG H60 convex probe 2-8 MHz Machine by the same sonographer, placental thickness will be measured at the level of the umbilical cord insertion excluding the myometrium and sub-placental veins<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance between estimated gestational age and combined transcerebellar diameter and placental thickness estimation | Concordance between the estimated gestational age using last menstrual period and dating ultrasound; and that estimated using combination of transcerebellar diameter and placental thickness | 32-36 weeks gestational age |