linjc16/ctgov huggingface dataset:
PROne POsition and Volumetric CAPnography

Study Overview
=================
Brief Summary
-----------------
Beneficial effect of prone position in ARDS on mortality is not linked to increase in PF ratio. It is probably due to improvement in ventilation-perfusion ratio (V/Q). Volumetric capnography allows assessment of dead space and homogeneity of V/Q. All prone positionned patients will be included in the study with usual monitoring (i.e. respiratory system basic mechanics, volumetric capnography, blood gas samples). Epidemiologic and monitoring data will be collected during all prone position sessions.

Official Title
-----------------
PROne POsition and Volumetric CAPnography

Conditions
-----------------
Prone Position, Mechanical Ventilation, Volumetric Capnography

Intervention / Treatment
-----------------
* Procedure: prone position


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all prone positioned patients Exclusion Criteria: age below 18 y, dependant patients, participation reject

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 |
| --- |
|Procedure: prone position|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| P3Slp | Evolution of phase 3 slope of volumetric capnography in survivors vs non-survivors | 24 hours |
The Diagnostic Methods of Early Postoperative Flare-up of Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
Crohn's disease is a chronic inflammatory transmural bowel disorder characterized by high rate of postoperative anastomotic complications and recurrences. Surgery itself can influence immunologic function and trigger inflammatory response, which may result in the flare of Crohn's disease soon after surgery (within one month), especially near the anastomosis. Early flare-up of Crohn's disease can negatively impact the outcomes of operation. However, due to the the complexity of perioperative period and dangerous of invasive examine, it is difficult to distinguish disease flare from postoperative complications. In this study, the investigators aim to development a diagnostic method of flare-up within one month after surgery, which can help us to detect and then treat disease flare in time.

Detailed Description
-----------------
HBI score, serum CRP, ESR, WBC, Hb, PLT, IL-6，PCT and fecal Calprotectin will be monitored within one month after resection.

Official Title
-----------------
The Diagnostic Methods of Crohn's Disease Flare-up Within One Month After Resection

Conditions
-----------------
Crohn's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing intestinal resection of all macroscopic disease, with an endoscopically accessible anastomosis, Exclusion Criteria: patients have an anastomosis which is endoscopically inaccessible by standard colonoscopy; patients withs persisting macroscopic abnormality after surgical resection; patients with an end stoma (ileostomy or colostomy); patients are not suitable to undergo endoscopy because of co-morbidities or an unwell clinical state; patients who are unable to give informed consent; patients who are pregnant

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 75 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 flare-up<br>Disease flare-up is demonstrated by coloscopy at one month after resection. | |
| patients without flare-up<br>No flare-up is found by coloscopy at one month after resection. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| flare-up confirmed by coloscopy |  | one month after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diagnostic Techniques, Digestive System
Intravitreal Injections of Ranibizumab With Deferred Laser Grid Laser Photocoagulation for Treatment of Diabetic Macular Edema With Visual Impairment

Study Overview
=================
Brief Summary
-----------------
In the prospective monocentric open label trial patients with diabetic macular edema will be treated with intravitreal injections of ranibizumab given for 3 months then with laser grid at month 4. During follow-up a ranibizumab injection will be performed every 2 months in case of best-corrected visual acuity decreased more than 5 letters.

Conditions
-----------------
Diabetic Macular Edema

Intervention / Treatment
-----------------
* Drug: ranibizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diabetes mellitus (1 or2) decreased vision from Diabetic Macular Edema (study eye Best Corrected Visual Acuity<69 letters using E.T.D.R.S testing) macular edema Exclusion Criteria: history of severe cardiac disease stroke within 12 months intraocular inflammation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 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: ranibizumab<br> | Drug: ranibizumab<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of intravitreal injections of ranibizumab |  | 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| best-corrected visual acuity |  | 1 years |
Miltefosine for Mucosal Leishmaniasis

Study Overview
=================
Brief Summary
-----------------
This trial will study miltefosine as a treatment for mucosal leishmaniasis.

Detailed Description
-----------------
Treat bolivian mucosal leishmaniasis with miltefosine.

Conditions
-----------------
Leishmaniasis

Intervention / Treatment
-----------------
* Drug: miltefosine 2.5 mg/kg/day for 28 days


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mucosal leishmaniasis Exclusion Criteria: Abnormal liver function tests (LFT) Abnormal kidney function test Concomitant diseases

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: miltefosine 2.5 mg/kg/day for 28 days|nan|

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

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mucosal, leishmaniasis, miltefosine
Questioning Patients About Adverse Medical Events: A Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
This trial studies whether 3 different methods of asking patients about adverse medical events in a clinical trial affects the rate of reported side effects.

Detailed Description
-----------------
214 patients involved in a larger randomized controlled trial of the herb, saw palmetto, for benign prostatic hyperplaisa were randomly assigned to 3 different methods of adverse event ascertainment after a 1-month placebo run-in visit. Two methods of ascertainment were open ended questions, and 1 was a checklist. Patients were blinded to group assignment, but investigators were aware (single blind). All patients had taken placebo for one month, but had been told it was a study drug (single blind).

Official Title
-----------------
Questioning Patients About Adverse Medical Events: A Randomized Controlled Trial

Conditions
-----------------
Benign Prostatic Hyperplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male, age > 49, American Urological Association Symptom Index > 8 Max urine flow rate > 4 and < 15 Exclusion Criteria: prior prostate cancer or surgery use of medications that affect urination severe concomitant illness

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

Sexes Eligible for Study
-----------------
Male

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adverse events, clinical trial methodology
Meal Composition and the Influence on Pre-prandial Blood Glucose Values

Study Overview
=================
Brief Summary
-----------------
The purpose of the proposed study is to assess the distribution of carbohydrates and fat in the diet of women with type 1 diabetes during pregnancy. More specifically, it will look at the distribution of carbohydrate in the diet during weeks 29-32 of pregnancy. The carbohydrate distribution and fat content of the meal will be compared to maternal glucose control, preprandial glucose levels, and the percentile for weight of the infant at birth. In addition, each meal and snack will be classified as low-moderate fat or high fat.

Detailed Description
-----------------
This is a retrospective chart review. Data will be collected on all patients seen whose blood sugar and food logs were at least 75% complete. By calculating carbohydrate amounts at meals and snacks, as well as classifying meals and snacks as high fat, we will examine the correlation to higher preprandial blood glucose values and large for gestational age infants. Preprandial glucose levels will be reviewed, questioning whether the biggest contributor is the composition of the previous meal or additional snacks between meals.

Official Title
-----------------
Meal Composition and Frequency in Type 1 Diabetic Women and the Influence on Pre-prandial Blood Glucose Values and Fetal Weight.

Conditions
-----------------
Diabetes in Pregnancy

Intervention / Treatment
-----------------
* Other: Carbohydrate intake


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female, age 16-45, all ethnic groups, Type 1 diabetes Blood glucose logs at least 75% complete Food intake records during weeks 29-32 that are at least 75% complete Exclusion Criteria: Maternal medical conditions: Renal disease Restrictive lung disease Cyanotic heart disease (severe heart disease where mother is blue) Antiphospholipid antibody syndrome Collagen-vascular disease (lupus) Substance use and abuse (drugs) Multiple gestation Genetic disorders Severe malnutrition

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Carbohydrate intake|By calculating carbohydrate amounts at meals and snacks, as well as classifying meals and snacks as high fat, the investigators will examine the correlation to higher preprandial blood glucose values and large for gestational age infants.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| large for gestational age infants | weight at birth | 1 year |
The Impact of Polycystic Ovary Syndrome (PCOS) on Quality of Life and Healthcare Beliefs

Study Overview
=================
Brief Summary
-----------------
Women with Polycystic Ovary Syndrome (PCOS) between the age of 18 and 55 are being recruited to participate in an online survey to determine the impact of PCOS on quality of life and interaction with the healthcare system. This online survey will take 15-20 minutes to complete. Participants will receive no direct benefit, but the information provided will contribute to the knowledge of this condition and the development of improved healthcare for women with PCOS. For more information or to participate in this study, please visit http://pcossurvey.vze.com

Official Title
-----------------
The Impact of PCOS on Quality of Life and Healthcare Beliefs

Conditions
-----------------
Polycystic Ovary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with Polycystic Ovary Syndrome (PCOS) between the age of 18 and 55 Exclusion Criteria: N/A

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCOS, polycystic ovary syndrome, Polycystic ovarian syndrome, infertility, ovulation
Study of FK778 in Renal Transplant Recipients With Untreated BK Nephropathy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and effectiveness of a new oral immunosuppressant agent compared to standard care in renal transplant patients diagnosed with BK nephropathy.

Detailed Description
-----------------
The purpose of this study is to assess the efficacy and safety of FK778 compared with standard care in renal transplant recipients with newly diagnosed and untreated BK nephropathy.

Official Title
-----------------
A Phase 2, Proof of Concept, Randomized, Open-label, Two-arm, Parallel Group, Multi-center Study to Assess the Efficacy and Safety of FK778 Compared With Standard Care in Renal Transplant Recipients With Untreated BK Nephropathy

Conditions
-----------------
BK Polyomavirus, Kidney Diseases

Intervention / Treatment
-----------------
* Drug: FK778


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Renal transplant recipient with newly diagnosed BK nephropathy. Exclusion Criteria: Previous treatment for BK nephropathy Organ transplant other than kidney Uncontrolled concomitant infection other than BK nephropathy

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

| Intervention/Treatment |
| --- |
|Drug: FK778|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in urine BK viral load |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in plasma BK viral load |  |  | 
| Change from baseline in renal function as measured by serum creatinine (SCr) and creatinine clearance (CrCl) at month 6 or at the end of therapy, whichever is earlier |  |  | 
| Change from baseline in renal histology measured by Drachenberg criteria at month 6 or at the end of therapy, whichever is earlier |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Investigational Therapies, Treatment Effectiveness, Treatment Efficacy, Immunosuppressant, BK Nephropathy, Polyomavirus, BK, Human Polyomavirus BK, Polyomavirus hominis 1
Goitres Influence on Voice Function - The Impact of Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate the influence benign non-toxic goitre and the surgical treatment hereof on the voice function before and 6 months following surgery.

Official Title
-----------------
The Impact of Surgical Treatment of Benign Non-toxic Goiter on the Voice Function

Conditions
-----------------
Goiter

Intervention / Treatment
-----------------
* Procedure: Thyroidectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients undergoing hemi- or total thyroidectomy for benign non-toxic goiter with pressure symptoms The patients must be able to understand, write and read Danish Exclusion criteria: Previous surgery to the neck Diabetes or any neuromuscular disorders. Present or previous head and neck malignancy, including malignancy found in the surgical thyroid specimen or suspicion hereof.

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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Thyroidectomy|Regular thyroidectomy or hemithyroidectomy through Kocher's skin incision|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with changed frequency range in voice function following thyroidectomy | Change in frequency range (Hz) of the Voice Range Profiler Phonetogram from baseline to 6 months after surgery. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Goitre, thyroid disease, struma
Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Hip

Study Overview
=================
Brief Summary
-----------------
To study the efficacy and safety of Naproxcinod vs. Placebo and Naproxen in the treatment of signs and symptoms of Osteoarthritis.

Detailed Description
-----------------
This is a 13 week randomized, double-blind, parallel group, multicenter study comparing efficacy and safety of Naproxcinod, Placebo and Naproxen.

Official Title
-----------------
A 13-Week, Phase 3, Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo Bid and Naproxen 500 mg Bid, Controlled Study on the Efficacy on Signs and Symptoms, and Safety of Naproxcinod (HCT3012) 750 mg Bid, in Patients With Osteoarthritis of the Hip

Conditions
-----------------
Osteoarthritis, Osteoarthritis, Hip

Intervention / Treatment
-----------------
* Drug: Naproxcinod
* Drug: Naproxen
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women (40 or older) with a diagnosis of primary OA of the hip Must be a current chronic user of NSAIDS or acetaminophen Must discontinue all analgesic therapy at Screening Exclusion Criteria: Uncontrolled Hypertension or Diabetes Hepatic or renal impairment Current or expected use of anticoagulant Clinically relevant abnormal ECG A history of alcohol or drug abuse Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding, within the last 6 months Current medical disease, including arthritic, that could confound or interfere with the evaluation of efficacy Candidates for imminent joint replacement Participation within 30 days prior to screening in another investigational study

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: Placebo<br>* bid<br>|
| Active Comparator: 2<br>Naproxen 500 mg | Drug: Naproxen<br>* 500 mg, bid<br>|
| Experimental: 3<br>Naproxcinod 750 mg | Drug: Naproxcinod<br>* 750 mg, bid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this study is to show that Naproxcinod is superior to placebo in relieving OA signs and symptoms in subjects with OA of the hip |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, Osteoarthritis, Hip
Post-marketing Surveillance of Atrovent® in Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
Study to obtain further information on the tolerability and efficacy of Atrovent® inhalets in the treatment of Chronic Obstructive Pulmonary Disease under conditions of daily practice

Official Title
-----------------
Post-marketing Surveillance (as Per § 67(6) AMG [German Drug Law]) of Atrovent® Inhalets in Chronic Obstructive Pulmonary Disease

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: Atrovent® - inhalets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of both gender older than 40 years, who suffer from Chronic Obstructive Pulmonary Disease Only patients who have not been treated with Atrovent® within the last year are to be considered for inclusion Exclusion Criteria: Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Atrovent® metered dose inhaler

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Chronic obstructive pulmonary disease patients<br> | Drug: Atrovent® - inhalets<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the clinical picture |  | after 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of efficacy by investigator on a 4-point scale |  | after 4 weeks | 
| Assessment of efficacy by patient on a 4-point scale |  | after 4 weeks | 
| Number of patients with adverse drug reactions |  | up to 4 weeks | 
| Assessment of tolerability by investigator on a 4-point scale |  | after 4 weeks | 
| Assessment of tolerability by patient on a 4-point scale |  | after 4 weeks |