linjc16/ctgov huggingface dataset:
Uremic Toxins in the Intensive Care Unit (ICU): Patients With Sepsis

Study Overview
=================
Brief Summary
-----------------
Study of the kinetics of uremic toxins in the ICU patients with acute renal failure, in order to optimize the dialysis dose: patients with sepsis/multi-organ failure. The sampling of blood and dialysate will be done during dialyses with different durations (4, 6 and 8h)

Official Title
-----------------
Study of the Kinetics of Uremic Toxins in the ICU Patients With Acute Renal Failure, in Order to Optimize the Dialysis Dose: Patients With Sepsis/Multi-organ Failure

Conditions
-----------------
Renal Failure, Multi Organ Failure

Intervention / Treatment
-----------------
* Procedure: Dialysis during 4 hours
* Procedure: Dialysis during 6 hours
* Procedure: Dialysis during 8 hours


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICU patients with sepsis/multi-organ failure with acute renal failure

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Dialysis during 4 hours | Procedure: Dialysis during 4 hours<br>* Blood and dialysate sampling<br>|
| Active Comparator: 2<br>Dialysis during 6 hours | Procedure: Dialysis during 6 hours<br>* Blood and dialysate sampling<br>|
| Active Comparator: 3<br>Dialysis during 8 hours | Procedure: Dialysis during 8 hours<br>* Blood and dialysate sampling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Registration of toxin removal efficiency |  | During dialysis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICU patients with acute renal failure with sepsis/multi-organ failure
Sjogrens Syndrome Measured by Ultrasound

Study Overview
=================
Brief Summary
-----------------
Ultrasound study focused on salivary gland outcomes in Sjogren's subjects

Detailed Description
-----------------
A 32 week ultrasound study for subject diagnosed with Sjogren's Syndrome. Subjects will receive Orencia (Abatacept) as intervention therapy during this trial.

Official Title
-----------------
Disease Modification in Sjogrens Syndrome Measured by Ultrasound: A Pilot Study

Conditions
-----------------
Sjogren's Syndrome

Intervention / Treatment
-----------------
* Biological: Orencia
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects diagnosed with Sjogren's Syndrome Exclusion Criteria: Subjects previously diagnosed with Sarcoidsis Subjects with positive for Hepatitis B, Hepatitis C, HIV Subjects diagnosed with Cancer within 5 years of screening

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

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Orencia (Abatacept)<br>Orencia (Abatacept) Intravenous (IV) or Subcutaneous (SQ) injection | Biological: Orencia<br>* FDA approved biologic<br>* Other names: Abatacept;|
| Placebo Comparator: Placebo<br>Placebo (saline solution) given Intravenous (IV) or Subcutaneous (SQ) | Other: Placebo<br> <br> * Other names: Saline;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary gland changes | Salivary gland changes detected by ultrasound imaging with elastography | 32 weeks |
Lung Ultrasound for Acute Dyspnea in Emergency Department

Study Overview
=================
Brief Summary
-----------------
Dyspnea is a frequent symptom in patients admitted to the Emergency Department (ED); discriminating between cardiogenic and non-cardiogenic dyspnea is a common clinical dilemma. The initial diagnostic work-out is often not very accurate in defining the etiology and the underlying pathophysiology. In the last years, lung ultrasound (US) has emerged as a useful real-time bedside diagnostic tool in the critical patient. The aim of this study was to evaluate the accuracy, reproducibility, and diagnostic impact of pleural and lung US, performed by emergency physicians at the time of patient first presentation to the ED, in identifying cardiac causes of acute dyspnea.

Official Title
-----------------
Lung Ultrasound for Acute Dyspnea in Emergency Department - Prospective Multicenter Study on Accuracy, Reproducibility, and Diagnostic Impact of Lung Ultrasound in the Evaluation of Patients With Dyspnea in the Emergency Department

Conditions
-----------------
Dyspnea, Congestive Heart Failure

Intervention / Treatment
-----------------
* Other: lung and pleural ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients had to present to the ED with a principal complaint of shortness of breath, deﬁned as either the sudden onset of dyspnea with no history of chronic dyspnea or an increase in the severity of chronic dyspnea in the last 48 hours; Presence of an emergency physician with lung US experience at the time of enrollment; US examination within 30 minutes after the start of the clinical evaluation. Exclusion Criteria: Dyspnea cases clearly due to neither cardiogenic nor respiratory etiology will considered not eligible.

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 |
| --- | --- |
| acute dyspnea<br> | Other: lung and pleural ultrasound<br>* After the initial diagnostic work-out (medical history, physical examination, EKG, arterious blood gas), the emergency physician will classify dyspnoea in cardiogenic or respiratory dyspnoea and write it down in a specific form (clinical form). Immediately after this, lung and pleural ultrasound will be performed: the physician will describe it and evaluate the etiology again (integrated evaluation form). Then a chest X-ray evaluation will be performed for each patient.<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
-----------------
Ultrasonography
Evaluation of a Miniaturized Microscope Device for the Detection of Barrett's Neoplasia: A Pilot Study

Study Overview
=================
Brief Summary
-----------------
The overall objective of this study is to obtain data to evaluate whether high-resolution imaging of barrett's esophagus in vivo can assist clinicians in detecting dysplastic (precancerous) areas. This is a pilot study of an novel technology, a miniaturized microscope device which can be used during upper endoscopy to image the gastrointestinal epithelium. This is an exploratory, not a comparative, study designed to evaluate the feasibility of using this instrument in Barrett's esophagus.

Official Title
-----------------
Evaluation of a Miniaturized Microscope Device for the Detection of Barrett's Neoplasia: A Pilot Study

Conditions
-----------------
Barrett's Esophagus

Intervention / Treatment
-----------------
* Drug: Proflavine Hemisulfate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Barrett's without dysplasia Barrett's with dysplasia Esophageal Adenocarcinoma Exclusion Criteria: Subjects unfit for standard upper endoscopy Subjects currently receiving chemo or radiation treatment Subject currently receiving PDT or ablation

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Proflavine Hemisulfate<br> | Drug: Proflavine Hemisulfate<br>* Proflavine hemisulfate 0.01% (derived from dissolving 10 mg Proflavine Hemisulfate USP in 100 ml of sterile water)<br>* Other names: Proflavine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether tissue is neoplastic or non-neoplastic |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Barrett's esophagus, in vivo imaging, image guide microscope
Association Between Laparoscopic Removal of Endometriomas and Anti-mullerian Hormone Levels

Study Overview
=================
Brief Summary
-----------------
Laparoscopic excision of endometriotic cysts is the main stream surgical intervention for treatment of endometriosis. However there is evidence that intervention may effect ovarian reserve by destruction of healthy ovarian tissue during surgery. Available evidence on the topic are contradictory and employed research methodology are diverse. There is need for an adequately powered research with proper methodology to assess actual effects of surgery.

Official Title
-----------------
Effects of Laparoscopic Endometrioma Removal on Anti-mullerian Hormone Levels

Conditions
-----------------
Endometriosis, Ovarian Reserve

Intervention / Treatment
-----------------
* Procedure: Laparoscopic removal of cysts


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with endometrioma cyst(s) Women of age under 35 years old Women without any previous ovarian surgery Exclusion Criteria: Combined oral contraceptive or long term GnRH (gonadotropin-releasing hormone) analog use in the preceding 3 months to enrolment Having another cystic lesion besides endometrioma Need for extensive bipolar coagulation during surgery Any anatomical problem preventing evaluation of ovaries with high-resolution ultrasound Postoperative pathology excluding endometrioma

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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 |
| --- | --- |
| Laparoscopic removal<br>Patients with endometrioma who will undergo laparoscopic removal of cysts. | Procedure: Laparoscopic removal of cysts<br>* Women with endometrioma lesions will undergo laparoscopic removal. Cysts will be enucleated with blunt dissection of the cyst capsule and following traction, counter traction maneuver. Bipolar coagulation will be used sparsely and suturing will be the predominant choice for achieving bleeding control.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-Mullerian hormone levels | AMH (anti-mullerian hormone) levels will be measured before surgery and during various time points up to 1 year after the surgery | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endometrioma, laparoscopy, anti-mullerian hormone, ovarian reserve
Different Dialysis Modalities and Diet on Gastrointestinal Biome and Azotaemic Toxins

Study Overview
=================
Brief Summary
-----------------
. This is a prospective observational pilot study to analyse gastrointestinal tract bacterial populations in peritoneal dialysis and haemodialysis patients under the care of the Royal Free Hospital with chronic kidney disease who have been established on regular haemodialysis and peritoneal dialysis treatments in a Royal Free Hospital kidney care centre.

Detailed Description
-----------------
Patients, attending for outpatient haemodialysis and peritoneal dialysis to be tested for gastrointestinal tract bacterial population by taking a single mouth swab, and a stool sample. Additional blood sampling, when patients are having blood tests for routine clinical assessment.

Official Title
-----------------
Pilot Study to Determine the Effect of Different Dialysis Treatment Modalities and Diet on Gastrointestinal Bacteria and Azotaemic Toxins

Conditions
-----------------
Kidney Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients age 18 years and older up to 80 years Under the care of the Royal Free Hospital with chronic kidney disease and established on regular haemodialysis or peritoneal dialysis. Able to provide written informed consent obtained Exclusion Criteria: Patients unable to provide written informed consent Patients not fulfilling inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| generation of bacterial phylogenetic trees by identifying different bacteria from stool samples and oral swabs by analysis of bacterial ribosomal 16S | observational | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure indoxyl sulphate (IS) and p-Cresyl sulfate (PCS) umol/L | observational | 8 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
microbiome, haemodialysis, peritoneal dialysis
Effects of Micronized Trans-resveratrol Treatment on Polycystic Ovary Syndrome (PCOS) Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether micronized trans-resveratrol improves clinical (excessive hair, menstrual cycle), endocrine (androgens)and metabolic (lipids, markers of systemic inflammation) in women with polycystic ovary syndrome (PCOS).

Official Title
-----------------
Effects of Micronized Trans-resveratrol Treatment on Clinical, Endocrine, Metabolic and Biochemical Parameters of Women With Polycystic Ovary Syndrome: Placebo-controlled Randomized Single-blind Study

Conditions
-----------------
Polycystic Ovary Syndrome (PCOS)

Intervention / Treatment
-----------------
* Dietary Supplement: Micronized trans-resveratrol
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PCO - Androgen Excess Society criteria: hyperandrogenism (hirsutism) / hyperandrogenemia (testosterone >70ng/dl) and/or oligomenorrhea (<8 spontaneous menses per year) and/or polycystic ovarian morphology on ultrasound Normal prolactin, TSH, 17-OH progesterone No evidence of androgen producing malignancy, Cushing's syndrome or acromegaly Age 18-40 Exclusion Criteria: Use of oral contraceptives and/or other steroid hormones 3 months prior to the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Micronized trans-resveratrol<br>Micronized trans-resveratrol | Dietary Supplement: Micronized trans-resveratrol<br> <br> * Other names: Micronized trans-resveratrol 500 (Rev Genetics LLC - Miami, FL, USA);|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| testosterone serum concentration |  | 3 month therapy |
Superobese Patients

Study Overview
=================
Brief Summary
-----------------
Super obesity (SO) is defined as a Body Mass Index (BMI) > 50 kg/m2, and represents the extreme severity of the disease, resulting in an increase in morbidity, mortality, and in poorer quality of life compared with morbid obesity (BMI > 35 and <50 kg/m2).

Official Title
-----------------
Predictive Factoris of Failure in Superobese Patients Undergoing Bariatric Surgery

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

Intervention / Treatment
-----------------
* Procedure: Bariatric surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Morbid and superobese patients Exclusion Criteria: Follow up not completed

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 |
| --- | --- |
| Superobese patients<br>Patients with preoperative BMI > 50 | Procedure: Bariatric surgery<br>* Sleeve gastrectomy<br>|
| Morbidobese patients<br>Patients with preoperative BMI > 35 and <50 | Procedure: Bariatric surgery<br>* Sleeve gastrectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical success | BMI <35 | 24 months |
Adjuvant Durvalumab for Esophageal Cancer

Study Overview
=================
Brief Summary
-----------------
Adjuvant Durvalumab vs Placebo for 1 year after complete resection of esophageal cancer following neoadjuvant CCRT.

Official Title
-----------------
Randomised, Double-blind, Phase II Trial of Adjuvant Durvalumab or Placebo for Completely Resected Esophageal Squamous Cell Carcinoma Previously Treated With Neoadjuvant Concurrent Chemoradiotherapy

Conditions
-----------------
Esophageal Cancer

Intervention / Treatment
-----------------
* Drug: Durvalumab
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed squamous esophageal cancer, irrespective of PD-L1 status The enrolment should be done during the time interval from 20 days to 56 days after complete resection after neoadjvuant CCRT (no residual tumor after operation) Clinical tumor stage before neoadjuvant CCRT should be T3-4N0M0 or T1-4N1-3M0 Available tumor specimen for biomarker analysis acquired before neoadjuvant CCRT or at operation Exclusion Criteria: Other PD-1 or PD-L1 inhibitors history Mean QT interval corrected for heart rate (QTc) ≥470 ms using Bazett's correction Current or prior use of immunosuppressive medication within 28 days before the first dose of MEDI4736, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid Active or prior documented autoimmune disease within the past 2 years NOTE: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Durvalumab<br>Durvalumab 20 mg/Kg IV Q 4 weeks for 1 year, or until disease relapse or unacceptable toxicity | Drug: Durvalumab<br> <br> |
| Placebo Comparator: Placebo<br>Placebo Q 4 weeks for 1 year, or until disease relapse or unacceptable toxicity | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival |  | 1 year |