linjc16/ctgov huggingface dataset:
Prophylactic Antibiotic Treatment During Vaginal Repair

Study Overview
=================
Brief Summary
-----------------
Prolapse of the uterus, bladder and rectum is a common condition in multiparous and/or elderly women. The number of operations for vaginal repair is increasing in Denmark, but there is no consensus or evidence found about the efficiency of prophylactic antibiotics intraoperatively concerning postoperative infections. The objective of this randomized, controlled trial is to investigate the significance of prophylactic antibiotic treatment in vaginal repair operations.

Official Title
-----------------
Antibiotikaprofylakse Ved Vaginalplastik

Conditions
-----------------
Uterine Prolapse, Cystocele, Rectocele, Enterocele

Intervention / Treatment
-----------------
* Drug: Cefuroxime


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women ages 18+ with uterine prolapse grade I - II and/or cystocele and/or rectocele and/or enterocele grade I - II and/or defects of the perineal body, in whom there is medical indication for vaginal repair, but no indication for vaginal hysterectomy or transvaginal suspension of the vaginal vault after prior hysterectomy. Exclusion Criteria: Patients allergic to cefuroxime. Patients in whom a vaginal hysterectomy or a transvaginal suspension of the vaginal vault or other major surgery is planned, where prophylactic antibiotic treatment is standard. Patients suffering from physical or mental disorders that will not allow them to give informed consent. Pregnant and nursing women.

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

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

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: Cefuroxime|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| primary endpoint: no infections (urinary tract infections, pneumonia,wound infections, infected haematomas, etc.) within 30 days postoperatively |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prophylactic antibiotic, Postoperative infections, Uterine prolapse grade I - II, cystocele, rectocele, enterocele, defects of the perineal body
Unilateral Approach for Bilateral Decompression of Lumbar Canal Stenosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to compare standard open laminectomy with ULBD approach in regard to efficiency, safety, and clinical outcome.

Detailed Description
-----------------
Lumbar stenosis is one of the common spinal pathologies; it presents with back pain, leg pain, and neurogenic claudication . Although different surgical modalities are available, the main objective of the operation is decompression of nerve roots and the spinal cord. Minimally invasive surgical procedures and microsurgical unilateral laminotomy with bilateral spinal canal decompression (ULBD) have been reported to achieve this goal . The objective of lumbar decompression is to decompress the neural elements while preserving stability and the spinous processes. The object of this study is to compare outcomes following minimally invasive unilateral laminectomy for bilateral decompression (ULBD) to a standard open laminectomy for LSS.

Official Title
-----------------
Unilateral Decompression Approach for Lumbar Canal Stenosis

Conditions
-----------------
Lumbar Spinal Stenosis

Intervention / Treatment
-----------------
* Procedure: unilateral laminotomy
* Procedure: decompressive laminectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age:40-80 years sex:both sexes symptomatic LSS with radiculopathy , neurogenic claudication , or urinary dysfunction. radiologically confirmed LSS , caused by degenerative changes canal stenosis at a maximum of 2 levels Exclusion Criteria: were to undergo a concomitant fusion or instrumentation placement; had had previous lumbar surgeries at the same level; had spondylolisthesis of any grade or degenerative scoliosis; had evidence of instability on dynamic radiographs.

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: unilateral laminotomy<br>patients with lumbar canal stenosis who undergo unilateral laminotomy for bilateral decompression | Procedure: unilateral laminotomy<br>* minimally invasive technique<br>|
| Experimental: decompressive laminectomy<br>patients with lumbar canal stenosis who undergo decompressive laminectomy | Procedure: decompressive laminectomy<br>* classic surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| back pain | visual analog scale | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neurogenic claudication pain | distance can be walked | one year |
Valopicitabine Alone and Together With Pegylated Interferon in Patients With Chronic Hepatitis C Who Have Failed to Respond to Standard Therapy

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to compare the safety, effectiveness and tolerance of valopicitabine (NM283) when used alone and when valopicitabine is used together with pegylated interferon in hepatitis C treatment failure patients. These results will be compared against the results of treatment with pegylated interferon plus ribavirin, the current standard therapy for treatment of hepatitis C viral infection.

Official Title
-----------------
A Randomized, Phase IIb Clinical Trial to Evaluate the Safety and Antiviral Activity of NM283 and the Combination of Pegylated Interferon Plus NM283, in Patients With Chronic Hepatitis C Who Have Previously Failed to Respond to Standard Therapy

Conditions
-----------------
Chronic Hepatitis C

Intervention / Treatment
-----------------
* Drug: valopicitabine
* Drug: pegylated interferon
* Drug: ribavirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented clinical history compatible with chronic hepatitis C and compensated liver disease Failed response to previous hepatitis C therapy of pegylated interferon/ribavirin Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Patient is pregnant or breastfeeding Patient is co-infected with hepatitis B or HIV Other protocol-defined exclusion criteria may apply.

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

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

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

| Intervention/Treatment |
| --- |
|Drug: valopicitabine|nan|
|Drug: pegylated interferon|nan|
|Drug: ribavirin|nan|

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
-----------------
Genotype-1, Previously failed treatment
Impact of Genetic Polymorphism on Propofol Requirement and Recovery for Total Intravenous Anesthesia for Clipping of Unruptured Cerebral Aneurysm in Korean Population

Study Overview
=================
Brief Summary
-----------------
In neurosurgical anesthesia, propofol based total intravenous anesthesia (TIVA) is frequently used due to brain relaxation and less effect on electrophysiologic monitoring. Response to propofol can vary between individuals and be associated with clinical factors including age and weight, and genetic polymorphism. Because the importance of rapid recovery in neurosurgery with long operation time is emphasized recently, the choice and dose adjustment of anesthetics should be determined according to clinical and genetic factors. Recently, researches about genetic variations have been performed with single nucleotide polymorphism (SNP). The aim of this study is to determine SNPs associated with propofol recovery and response in Korean adult population undergoing propofol based TIVA for clipping of unruptured cerebral aneurysm.

Conditions
-----------------
Unruptured Cerebral Aneurysm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Korean adult population undergoing propofol based TIVA for clipping of unruptured cerebral aneurysm Exclusion Criteria: patients not able to read, or understand the consent form ethnicity, other than Korean population patients refusal patients not to perform total intravenous anesthesia

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| undergoing propofol based TIVA for clip<br>This study is an observational study performed in adult patients undergoing propofol based TIVA for clipping of unruptured cerebral aneurysm. We will collect data regarding recovery after stopping propofol infusion (time for eye opening and extubation), propofol requirement during anesthesia maintenance, and propofol effect site concentration to achieve bispectral index 40 during anesthesia induction, without doing any interventions. Data collection will be established with just observing and recording values displayed in screens of monitoring devices, and reviewing patient charts. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of eye opening after stopping propofol infusion |  | within about one hour from end of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
propofol, total intravenous anesthesia, cerebral aneurysm, single nucleotide polymorphism
Study on Seroprevalence and Risk Factors of Coxiella Burnetii (Q Fever) in the South of Reunion Island

Study Overview
=================
Brief Summary
-----------------
Emergent and infectious diseases are a public health priority on Reunion Island. Amongst public health threats, the infection due to Coxiella burnetii (Q fever) seems to have appeared on Reunion island in 2007 with two hospitalised confirmed cases (one death) and one probable case with a goat farmer. According to the investigator, the diffusion of C. burnetti is more ancient and such diagnosis have been made in the last 30 years with 80 positive serologies identified between 2005 and 2011. Considering the high epidemic power of this disease, its often silent clinical expression and its life-threatening condition, the principal investigator wishes to perform a sero-epidemiological study in order to establish or to reject the risk of emergence of Q fever in Reunion island. The study will be performed on pregnant women because Q fever is responsible for particular complications during pregnancy and because the number of pregnancy followed on Reunion island is stable from one year to the other. The pregnant women population presenting the same exposure criteria as the general population, this population will be used to extrapolate to the general population of the island.

Official Title
-----------------
Study on Seroprevalence and Risk Factors of Coxiella Burnetii (Q Fever) in the South of Reunion Island

Conditions
-----------------
q Fever

Intervention / Treatment
-----------------
* Procedure: blood sample and questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all pregnant women coming to the two maternity hospitals located in the south of Reunion island during inclusion period who have been informed and gave consent to participate to the study. Exclusion Criteria: women aged less than 18 years old. women who did not give their consent women for whom it is not possible to perform the blood sample.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: blood sample and questionnaire|In addition to normal blood sample performed at entry before delivery, an extra 5 ml blood sample will be taken to establish Q fever serodiagnosis and a short questionnaire will be filled in for clinical and epidemiological data.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of Coxiella burnetii infection in general population in the south of Reunion island | Q fever seroprevalence obtained from blood samples taken on pregnant women hospitalised for delivery will be used to extrapolate to Reunion island general population Q fever seroprevalence. | at inclusion |
Estimating Risk of Respiratory Infections Attributable to CFTR Heterozygosity

Study Overview
=================
Brief Summary
-----------------
A research team member will brush the inferior surface of the subjects' middle turbinate (nasal cavity) using a cytology brush to obtain the cells needed to perform our functional respiratory assays. An individual trained in phlebotomy will draw one 3 ml lavender top tube of blood to test c-reactive protein, calprotectin, and lactoferrin. They will also draw a 5 ml gold top serum separator tube of blood to test fibroblast growth factor-19. The participant will answer questions from the baseline survey and report their current medications interview-style with the research team member.

Official Title
-----------------
Estimating the Risk for and Severity of Respiratory Infections Attributable to CFTR Heterozygosity

Conditions
-----------------
Carrier State, Respiratory Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
CF Carrier Inclusion Criteria: Previously tested and shown to be a CF carrier English-speaking Control Group Inclusion Criteria: Previously tested and shown to not be a CF carrier or CF patient English-speaking Exclusion Criteria: Currently sick with a respiratory infection Prisoner Status Unable to provide own written, informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cystic Fibrosis Carrier Group<br>Participants have been identified as Cystic Fibrosis Carriers via previous genetic testing. | |
| Control Group<br>Participants have been identified as not being Cystic Fibrosis Carriers via previous genetic testing. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Chloride Transport Values | Comparison of chloride transport values in cystic fibrosis carrier group vs control group via t-test. | At baseline | 
| Comparison of Bicarbonate Transport Values | Comparison of bicarbonate transport values in cystic fibrosis carrier group vs control group via t-test. | At baseline | 
| Comparison of Airway Surface Liquid pH Values | Comparison of airway surface liquid pH values in cystic fibrosis carrier group vs control group via t-test. | At baseline | 
| Comparison of Mucous Viscosity Values | Comparison of mucous viscosity values in cystic fibrosis carrier group vs control group via t-test. | At baseline | 
| Comparison of Bacterial Killing Values | Comparison of bacterial killing values in cystic fibrosis carrier group vs control group via t-test. | At baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Fibroblast Growth Factor-19 Values | Comparison of fibroblast growth factor-19 values in cystic fibrosis carrier group vs control group via t-test. | At baseline |
The Risk of Uncomplicated Peptic Ulcer in a Cohort of Secondary Prevention Aspirin Users

Study Overview
=================
Brief Summary
-----------------
This study is conducted in a cohort of low dose aspirin (ASA) users previously ascertained. The aims of the post hoc analyses are: To estimate the incidence of uncomplicated peptic ulcer (UPU) in a cohort of low-dose ASA for secondary prevention of vascular disease and the relative risk of UPU associated with use and discontinuation of use of low dose ASA. To estimate the effect of proton pump inhibitors (PPI) on the occurrence of UPU among users of low-dose ASA for secondary prevention of vascular disease To evaluate the effect of other risk factors on the occurrence of UPU among users of low-dose ASA for secondary prevention of vascular disease.

Detailed Description
-----------------
The risk of uncomplicated peptic ulcer in a cohort of secondary prevention aspirin users

Official Title
-----------------
The Risk of Uncomplicated Peptic Ulcer in a Cohort of Secondary Prevention Aspirin Users

Conditions
-----------------
Uncomplicated Peptic Ulcer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients aged 50-84 years in 2000-2007 with a first prescription of low dose ASA ( see study population description) Exclusion Criteria: - Patients aged below age 50 and 85 years and above ( see study population description)

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 84 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 prescription for low dose ASA (75-300 mg/day)<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rates of uncomplicated peptic ulcer in a cohort of secondary prevention aspirin users |  | From 1 January 2000 till 30 September 2011, an expected average of 6 years. | 
| Risk (hazard ratio) of developing uncomplicated peptic ulcer in a cohort of secondary prevention aspirin users |  | From 1 Januart 2000 till 30 September 2011, an expected average of 6 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Uncomplicated peptic ulcer, Acid-suppressing drugs, Epidemiology
Sufentanil Pharmacokinetics After Intra Amniotic Injection

Study Overview
=================
Brief Summary
-----------------
The fetus may be exposed during pregnancy to nociceptive stimuli because of fetal pathology (e.g., malformation) or a diagnostic or therapeutic procedure. To date, there is very little data and no consensus on fetal analgesia. The aim of the investigators study is to evaluate the pharmacokinetics of Sufentanil after intra amniotic injection.

Official Title
-----------------
Assessment of Fetal and Maternal Sufentanil Pharmacokinetics After Intra-amniotic Injection

Conditions
-----------------
Prenatal Diagnosis

Intervention / Treatment
-----------------
* Drug: Sufentanil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Termination of pregnancy for fetal malformation Gestational age > 24 weeks of gestation Exclusion Criteria: Multiple pregnancy Allergy or contraindication to sufentanil Morphinic addiction fetal gastroschisis, omphalocele or swallowing disorder maternal cardiac or respiratory distress

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

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

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: Sufentanil<br> | Drug: Sufentanil<br>* intra-amniotic injection of 10 micrograms of Sufentanil<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fetal plasma concentrations | fetal plasma concentrations of morphine derivatives by Ultrahigh Pressure Liquid Chromatography (UPLC) with mass spectometry (Triple Quadrupole Detector) | at 30 minutes after intra-amniotic injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal plasma concentrations | Maternal plasma concentrations of morphine derivatives by Ultrahigh Pressure Liquid Chromatography (UPLC) with mass spectometry (Triple Quadrupole Detector) | at 30 minutes and at 1, 2, 4, 8, 24 hours after intra-amniotic injection | 
| amniotic fluid concentrations | The amniotic fluid concentrations of morphine derivatives by Ultrahigh Pressure Liquid Chromatography (UPLC) with mass spectometry (Triple Quadrupole Detector) | Immediately within 5 min after intra-amniotic injection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fetal pain, fetal analgesia