linjc16/ctgov huggingface dataset:
Evaluation of the Safety and Effectiveness of Sepraspray™ in Reducing Post-surgical Adhesions

Study Overview
=================
Brief Summary
-----------------
This study will examine the safety and efficacy of Sepraspray in the following model of abdominal surgery: total proctocolectomy and pelvic pouch with diverting ileostomy via laparotomy to treat ulcerative colitis or familial polyposis. Adhesion formation will be evaluated laparoscopically at ileostomy take down. NOTE: A decision was made to terminate this study in June 2008 due to low enrollment.

Official Title
-----------------
Evaluation of the Safety and Effectiveness of Sepraspray™ in Limiting the Formation of Postoperative Adhesions to Serosal Tissue (Abdominal Surgery)

Conditions
-----------------
Abdominal Adhesions

Intervention / Treatment
-----------------
* Device: Sepraspray


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are scheduled to undergo a total proctocolectomy and a pelvic pouch with diverting ileostomy. Exclusion Criteria: Patients who are pregnant. Patients with ongoing abdominal abscess. Patients with ongoing bacterial peritonitis.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sepraspray<br>Sepraspray Powder applied on the viscera directly under the midline incision followed by incision closure. Sepraspray dose applied was between 2 g and 4 g per patient. | Device: Sepraspray<br> <br> |
| No Intervention: Control<br>No anti-adhesion treatment used. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Primary efficacy endpoints include the incidence of adhesions to the midline incision |  | 8-14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary: efficacy endpoints include the extent of adhesions to the midline incision and the severity of adhesions to the midline incision. |  | 8-14 weeks | 
| Safety: safety endpoints include assessments of adverse events, vital signs, incisional wound healing, clinical laboratory evaluations, and concomitant medications. |  | 8-14 weeks |
Diurnal Variation of Uremic Solutes in Peritoneal Dialysis

Study Overview
=================
Brief Summary
-----------------
Study on the daytime variation of uremic retention solutes and markers of bone-mineral metabolism in patients with end-stage kidney disease treated with peritoneal dialysis

Detailed Description
-----------------
Many epidemiological studies have pointed to the association between serum parameters of phosphate metabolism (phosphate, FGF23) and microbiotic protein fermentation (p-cresyl sulphate [PCS], indoxyl sulphate [IS]) on the one hand and increased risk of all-cause and cardiovascular death on the other hand. Hypothesis: Due to failing feed-back mechanisms, diurnal variation of serum concentrations of serum phosphate and fermentation metabolites will be more pronounced in dialysis patients, especially in those with negligible residual kidney function. Clinical studies assessing this issue are scarce to non-existing.

Official Title
-----------------
Diurnal Variation of Mineral Metabolism and Protein Fermentation Metabolites in Peritoneal Dialysis Patients and Healthy Volunteers

Conditions
-----------------
Chronic Kidney Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-55 Normal dietary habits Exclusion Criteria: Treatment with systemic antibiotics within one month Major abdominal surgery Drugs known to affect gastrointestinal physiology (acid secretion inhibitors, prokinetics, laxatives, probiotics, prebiotics,..)

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

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 |
| --- | --- |
| chronic kidney disease<br>ESKD patients treated with peritoneal dialysis | |
| Healthy volunteers<br>healthy volunteers, aged 18 years and above | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the diurnal variation of serum concentrations of phosphate and protein fermentation metabolites in healthy volunteers as compared to dialysis patients. |  | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diurnal variation, peritoneal dialysis, uremic retention solutes, phosphorous, indoxyl sulfate, p-cresol sulfate
Bariatric Surgery and Pharmacokinetics of Apixaban

Study Overview
=================
Brief Summary
-----------------
Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study we investigate the pharmacokinetic effects of bariatric surgery on apixaban.

Official Title
-----------------
Bariatric Surgery and Pharmacokinetics of Apixaban: BAR-MEDS Apixaban

Conditions
-----------------
Obesity, Morbid

Intervention / Treatment
-----------------
* Drug: Apixaban


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway Being a Norwegian citizen Exclusion Criteria: Having previously undergone resections in the GI-tract

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Apixaban|Patients are tested for their normal prescription apixaban medication|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apixaban concentration in blood serum (area under curve (AUC)) |  | From baseline to 1 year postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bariatric surgery, Gastrointestinal tract, Biological availability, Pharmacokinetics, Apixaban
Evaluation of TP US in Women With Prolapse

Study Overview
=================
Brief Summary
-----------------
Many women suffers from uterine and vaginal prolapse Usually they suffer from these symotoms in menopause

Detailed Description
-----------------
The most common cause of pelvic organ prolapse is multiple pregnancy and multiparity

Official Title
-----------------
Evaluation of TP US Assesment of Women With Prolapse

Conditions
-----------------
Prolapse

Intervention / Treatment
-----------------
* Diagnostic Test: Ultrasonography TP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with history of normal delivery Age between 25 to 75 years Exclusion Criteria: women with cesarean deliveries

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Ultrasonography TP|TP us will be made to the included women|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of women who will be properly diagnosed with prolapse by TP us | The accuracy of TP US in diagnosing the prolapse | within 2 months |
Study Evaluating the Safety, Tolerability and Pharmacokinetics of NSA-789 in Healthy Japanese Male Subjects

Study Overview
=================
Brief Summary
-----------------
This study will provide an initial assessment of the safety, tolerability and pharmacokinetics (PK) of NSA-789 after administration of ascending single oral doses to healthy Japanese male subjects. This is a randomized, double-blind, placebo-controlled, inpatient, sequential-group study conducted under fasting conditions at a single investigational site. Each subject will participate in only 1 dose group and will receive only 1 dose of test article.

Official Title
-----------------
Ascending Single Dose Study of the Safety, Tolerability and Pharmacokinetics of NSA-789 Administered Orally to Healthy Japanese Male Subjects

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

Intervention / Treatment
-----------------
* Drug: NSA-789
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men aged 20 to 45 years inclusive at screening. Healthy as determined by the investigator on the basis of screening evaluations. Exclusion Criteria: Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. Use of any investigational drug within 90 days before study day 1 or prescription drug within 30 days before study day 1 Any clinically important deviation from normal limits in physical examination, vital signs, 12-lead electrocardiograms (ECGs), or clinical laboratory test results.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NSA-789<br> | Drug: NSA-789<br> <br> |
| Placebo Comparator: Placebo<br> | Other: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy
Semi-automated Segmentation Methods of SSTR PET for Dosimetry Prediction

Study Overview
=================
Brief Summary
-----------------
Tumor dosimetry with somatostatin receptor-targeted peptide receptor radionuclide therapy (SSTR-targeted PRRT) by 177Lutetium-DOTATATE might contribute to improve follow-up and treatment response of refractory meningiomas. This study aims to evaluate Standard Uptake Value mean (SUVmean) as a tumoral absorbed dose predictive predictive factor and propose semi-automated segmentation method to determine metabolic tumor volume with pretherapeutic 68-Gallium-DOTATOC PET.

Official Title
-----------------
Semi-automated Segmentation Methods of SSTR PET for Dosimetry Prediction in Refractory Meningiomas Treated by SSTR-targeted Peptide Receptor Radionuclide Therapy

Conditions
-----------------
Refractory Meningioma

Intervention / Treatment
-----------------
* Other: To evaluate the SUVmean (Standard Uptake Value) as a predictive factor of the tumor absorbed dose compared to the SUVmax


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with meningioma Exclusion Criteria: - PET scan not available

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| 20 patients with meningioma<br>20 meningioma patients will be included in this study, 10 of whom will have been treated with Lutathera®. | Other: To evaluate the SUVmean (Standard Uptake Value) as a predictive factor of the tumor absorbed dose compared to the SUVmax<br>* Measure SUVmean (Standard Uptake Value) and SUVmax on PET exams<br>|
| 10 patients will have been treated with Lutathera®.<br>10 patients of the 20 will have been treated with Lutathera®. | Other: To evaluate the SUVmean (Standard Uptake Value) as a predictive factor of the tumor absorbed dose compared to the SUVmax<br>* Measure SUVmean (Standard Uptake Value) and SUVmax on PET exams<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the SUVmean (Standard Uptake Value)as a predictive factor of the tumor absorbed dose compared to the SUVmax | Measurements of SUVmean and SUVmax at the lesion level on 68Ga-DOTATOC PET/CT Correlation between SUVmean and max measurements with tumor absorbed doses. | 2 months | 
| To propose a semi-automated segmentation | Propose a semi-automated segmentation method for determining metabolic tumor volume with pretherapy DOTATOC labelled with gallium-68 PET. (68Ga-DOTATOC PET) | 1 month |
PRedictiOn Algorithms for the DeTECTion of Early Stage Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
Conduct a prospective study to assess the accuracy of a pancreatic cancer risk prediction model.

Detailed Description
-----------------
The goal of this study is to establish a platform for development and implementation of a data-driven risk model for detection of early stage pancreatic cancer within an integrated health care setting. Patients at increased risk for pancreatic cancer as identified by the risk model will be invited to participate in a prospective study to assess the accuracy of this approach for detection of early stage pancreatic cancer.

Official Title
-----------------
PRedictiOn Algorithms for the DeTECTion of Early Stage Pancreatic Cancer

Conditions
-----------------
Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma (PDAC)

Intervention / Treatment
-----------------
* Diagnostic Test: Magnetic resonance imaging (MRI)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient must have 6 months of membership Patient has a measure for weight, Hemoglobin A1C, and Alanine transaminase (ALT) within the past 6 months Patient must have an increased predicted 18-month risk of pancreatic cancer based on the PRO-TECT model Speaks English or Spanish Exclusion Criteria: Previous or current history of pancreatic cancer Metastatic cancer Current active cancer or undergoing chemotherapy for cancer Currently pregnant or breastfeeding Class IV heart failure Cirrhosis with ascites and/or varices Currently in a skilled nursing facility or under hospice care Has metal parts or implanted devices in the body, such as a pacemaker, defibrillator, or shrapnel End stage renal disease Cognitive impairment such that the person is unable to provide informed consent

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 |
| --- | --- |
| Risk of pancreatic cancer<br>Subjects with an increased predicted 18-month risk of pancreatic cancer | Diagnostic Test: Magnetic resonance imaging (MRI)<br>* All enrolled participants will undergo magnetic resonance imaging (MRI) at their Baseline and 18-Month follow-up visit<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of pancreatic ductal adenocarcinoma (PDAC) in the high predicted risk group | Enrolled subjects will be followed for 18 months to determine the incidence rate of PDAC | 18-Month |
Pharmacokinetic Study of 48-hour Sevoflurane Inhalation Using a Disposable Delivery System (AnaConDa©) in ICU Patients With Acute Kidney Injury

Study Overview
=================
Brief Summary
-----------------
Describing a pharmacokinetic model of 48-h sevoflurane sedation in ICU patients with acute kidney failure

Detailed Description
-----------------
Prospective clinical monocentric study in ICU with sedated ventilated patients (presenting acute kidney failure) with sevoflurane during 48 h with the AnaConda® system, establishing pharmacokinetic model of sevoflurane and its metabolites (hydroxyfluroisopropanol, fluoride)

Official Title
-----------------
Pharmacokinetic Study of 48-hour Sevoflurane Inhalation Using a Disposable Delivery System (AnaConDa©) in ICU Patients With Acute Kidney Injury

Conditions
-----------------
Acute Kidney Injury

Intervention / Treatment
-----------------
* Drug: Sedation with sevoflurane during 48-hr in ICU


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Adult patients ventilated more than 48 h Stable respiratory and hemodynamic conditions Consent of patients or family Arterial line AKIN score = 3 Exclusion Criteria: BMI <30 Sevoflurane anaphylaxia

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sevoflurane<br>Determination of plasmatic concentrations of sevoflurane at different times of a 48h sedation of sevoflurane in ICU patients with acute kidney injury | Drug: Sedation with sevoflurane during 48-hr in ICU<br> <br> * Other names: Determination of plasmatic concentrations of sevoflurane at different times of a 48h sedation of sevoflurane in ICU patients with acute kidney injury;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of plasmatic concentrations of sevoflurane before using AnaConda® system |  | at 5min, 60 min, 24 hrs and just before the end of sedation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of plasmatic concentrations of HFIP and fluoride |  | at 5min, 15 min, 60 min and just before the end of sedation. And 5 min, 10 min, 30 min, 120 min and 360 min after the end of sedation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacokinetics, Sevoflurane, Acute kidney injury, Sedation, ICU patients
Safety of Cultured Allogeneic Adult Umbilical Cord Stem Cells for Trigeminal Neuralgia and Peripheral Neuropathy

Study Overview
=================
Brief Summary
-----------------
This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Trigeminal Neuralgia and Peripheral Neuropathy

Detailed Description
-----------------
This patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of Trigeminal Neuralgia and Peripheral Neuropathy. Patients will receive intravenous infusion of UC-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy. For patients with more severe disease an autologous Effector cells (activated lymphocytes) treatment will be utilized created from the patient's own cells obtained by apheresis.

Official Title
-----------------
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Trigeminal Neuralgia and Peripheral Neuropathy

Conditions
-----------------
Peripheral Neuropathy, Trigeminal Neuralgia

Intervention / Treatment
-----------------
* Biological: AlloRx


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Trigeminal Neuralgia or Peripheral Neuropathy Understanding and willingness to sign a written informed consent document Exclusion Criteria: Active infection Active cancer Chronic multisystem organ failure Pregnancy Clinically significant Abnormalities on pre-treatment laboratory evaluation Medical condition that would (based on the opinion of the investigator) compromise patient's safety. Continued drug abuse Pre-menopausal women not using contraception Previous organ transplant Hypersensitivity to sulfur
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: Treatment Group (AlloRx)<br>Single intravenous infusion of 100 million cells | Biological: AlloRx<br>* cultured allogeneic adult umbilical cord derived mesenchymal stem cells<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (adverse events) | Clinical monitoring of possible adverse events or complications | Four year follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peripheral Neuropathy, Trigeminal Neuralgia, stem cell treatment