linjc16/ctgov huggingface dataset:
Clinical and Biochemical Effects of Multipass Hemodialysis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether recycled dialysis fluid can supply enough clearance for hemodiaysis patients.

Detailed Description
-----------------
Conventional hemodialysis uses large amounts of water, which hinders travel possibilies for home hemodialysis (HD) patients. We have developed a recycling system using 25-30 l dialysate per dialysis. In vitro investigations show that this results in adequate dialysis. 12 HD patients will be studied during two dialysis sessions. The first HD will be a conventional 4 hour dialysis, using single pass dialysate. The second will be an 8-hour HD using multipass (recycled) dialysate 25-30 l. Clearance of urea, creatinine, phosphate and cobalamin will be measured both in the patient and the dialysate. Patient symptoms will be recorded.

Official Title
-----------------
Clinical and Biochemical Effects of Multipass Hemodialysis

Conditions
-----------------
Uremia

Intervention / Treatment
-----------------
* Device: Multipass hemodialysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable chronic HD patients Informed consent Exclusion Criteria: Age <18 years Psychiatric disease

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conventional HD<br>conventional 4-hour HD | Device: Multipass hemodialysis<br>* 8-hour dialysis using a recycled dialysis bath of 25-30 l<br>* Other names: dialysate;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urea Kt/V |  | 9 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Creatinine clearance |  | 9 hours | 
| Patient symptoms |  | 9 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dialysis, hemodialysis, Effect of recycled low-volume dialysate on dialysis efficacy
Laminaria and Misoprostol Before Operative Hysteroscopy

Study Overview
=================
Brief Summary
-----------------
Laminaria and Misoprostol before Operative Hysteroscopy

Detailed Description
-----------------
The use of laminaria versus laminaria plus misoprostol was compared before operative hysteroscopy in nulliparous women to assess the efficacy of both methods in cervical dilatation.

Official Title
-----------------
The Use of Laminaria Versus Laminaria Plus Misoprostol Before Operative Hysteroscopy in Nulliparous Women . A Double Blinded Randomized Trial.

Conditions
-----------------
Cervical Spasm

Intervention / Treatment
-----------------
* Device: Laminaria tent
* Drug: Laminaria plus Misoprostol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: nullipara need hystroscopic intervention Exclusion Criteria: previous pregnancy cervical lesion contraindication to misoprostol -

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laminaria<br>Laminaria tent was introduced in the cervical canal | Device: Laminaria tent<br>* Laminaria tent was inserted for 12 hours before Hysteroscopy<br>|
| Active Comparator: Laminaria plus Misoprostol<br>Laminaria and Misoprostol were introduced | Drug: Laminaria plus Misoprostol<br>* Laminaria plus Misoprostol were inserted for 12 hours before Hysteroscopy<br>* Other names: cytotec,;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preoperative cervical width | cervical width in Hegar dilators number | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse effects | adverse effects of the method used or hysteroscopy | 24 hours |
A Study of LY3314814 in Healthy Participants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure how much LY3314814 gets into the bloodstream when it is given as a single dose by mouth and as an intravenous (IV) infusion over two hours. The study will last at least two weeks for each participant, not including screening.

Official Title
-----------------
An Absolute Bioavailability Study of LY3314814 in Healthy Subjects Using an Intravenous Tracer Method

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

Intervention / Treatment
-----------------
* Drug: LY3314814
* Drug: [13C415N3] LY3314814


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Are overtly healthy males or females Have venous access sufficient to allow for blood sampling and intravenous (IV) administration of the investigational product Exclusion Criteria: Have a history of significant ophthalmic disease Have vitiligo or any other clinically significant disorder of skin pigmentation Have a history of use of antipsychotic drugs, or chronic use of antidepressant or anxiolytic drugs, prescribed as well as non-prescribed

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: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3314814<br>Single 50 milligram (mg) dose of LY3314814 administered orally | Drug: LY3314814<br>* Administered orally<br>|
| Experimental: [13C415N3] LY3314814<br>Single 100 micrograms (μg) intravenous (IV) dose of [13C415N3] LY3314814 administered as an IV infusion. | Drug: [13C415N3] LY3314814<br>* Administered as an IV infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute Bioavailability of LY3314814 | Absolute bioavailability was quantified using a mixed-effects analysis of variance (ANOVA) model applied to the log-transformed dose-normalized AUC(0-∞) of LY3314814 oral dosing and IV administered [13C415N3]-LY3314814. | Day 1: Predose:0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24, 48, 72, 96 and 120 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Area Under the Drug Concentration-Time Curve From Zero to Infinity (AUC[0 ∞]) of LY3314814 and [13C415N3] LY3314814 | Pharmacokinetics: Area Under the Drug Concentration-Time Curve from Zero to Infinity (AUC[0 ∞]) of LY3314814 and [13C415N3] LY3314814 | Day 1: Predose:0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24, 48, 72, 96 and 120 hours post-dose |
A New Portable Monitor for Measuring Odorous Compounds in Oral, Exhaled and Nasal Air

Study Overview
=================
Brief Summary
-----------------
The B/B Checker, a new portable device for detecting odorous compounds in oral, exhaled, and nasal air, is now available. As a single unit, this device is capable of assessing several kinds of gases mixed with volatile sulfur compounds (VSCs) in addition to other odorous gasses. The purpose of the present study was to evaluate the effectiveness of the B/B Checker for detecting the malodor level of oral, exhaled, and nasal air.

Conditions
-----------------
Halitosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of oral malodor Exclusion Criteria: Smoker Medical disorders Undergoing any antibiotic or other antimicrobial therapy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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
-----------------
Halitosis
Phase 2 Study of ABX-EGF (Panitumumab) in Japanese Subjects With M-colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess the effect of treatment with ABX-EGF on best overall objective response rate by modified RECIST (confirmed complete or partial response) in Japanese subjects with metastatic colorectal cancer.

Official Title
-----------------
A Phase 2 Multicenter Single Arm Clinical Trial of ABX EGF (Panitumumab) Monotherapy in Japanese Subjects With Metastatic Colorectal Cancer Who Developed Progressive Disease or Relapsed While on or After Prior Fluoropyrimidine, Irinotecan and Oxaliplatin Chemotherapy

Conditions
-----------------
Metastatic Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: ABX-EGF (panitumumab)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Metastatic colorectal adenocarcinoma; Subjects must have become refractory to treatment or unable to continue treatment due to toxicity or other reasons during or after treatment with fluoropyrimidine, irinotecan and oxaliplatin for metastatic colorectal cancer including those who relapsed during or within 6 months from the completion of adjuvant therapy using the above agents; - Tumor expressing EGFr levels by immunohistochemistry (membrane staining must be positive in 1% of evaluated tumor cells). Exclusion Criteria: Subjects who have prior experimental or approved antibodies (eg, bevacizumab) within 3 months before enrollment; Subjects who have prior EGFr targeting agents; Chemotherapy other than fluoropyrimidine (including oral agents such as UFT, TS-1), irinotecan, and oxaliplatin (or raltitrexed) for colorectal carcinoma in accordance with specified regimens (leucovorin and levamisole are not considered as chemotherapy

Ages Eligible for Study
-----------------
Minimum Age: 20 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: ABX-EGF (panitumumab)|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
-----------------
EGFR, Fully human, Monoclonal antibody, Panitumumab, ABX-EGF, AMG954, Colorectal Cancer, Japan
Blood Viscosity, End-Stage Renal Disease, And Mortality (BEAM-1)

Study Overview
=================
Brief Summary
-----------------
Prospective, real-time observational study of hemodialysis patients treated with erythropoiesis-stimulating agents (ESA) to currently recommended Hgb targets. Subjects will be evaluated dynamically for their blood viscosity status at the beginning and end of the dialysis treatment, and followed prospectively to assess outcomes. Blood specimens will be collected via the subject's hemodialysis port pre- and post-hemodialysis per study assessment visit. Blood will be analyzed at a designated laboratory facility for viscosity over a comprehensive range of shear rates and tested for intradialytic surges in blood viscosity. Subjects will be followed for 48 weeks.

Official Title
-----------------
Clinical Diagnostic Evaluation Study of Blood Viscosity, End-Stage Renal Disease, And Mortality

Conditions
-----------------
Renal Replacement Therapy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years old On hemodialysis > 3 months On ESA treatment > 3 months Mean Hgb 11 g/dL - 12 g/dL (based on at least 3 Hgb results during the previous 8 weeks) Latest Hgb 10.5 g/dL - 12.5 g/dL (measured within 1 week of study) Exclusion Criteria: Inability or unwillingness to provide informed consent Large variability in interdialytic weight gain (>2 kg difference between low and high weight gain over last month) More than 1 missed dialysis treatments in past month Recent bleeding Blood transfusion within 1 month Hematologic disease other than anemia Active inflammatory disease Active infection

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 |
| --- | --- |
| End-stage renal disease<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular mortality |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | One year | 
| Vascular access thrombosis |  | One year |
Study of Combined Intercostal and Diaphragm Pacing for Artificial Respiration in Quadriplegic Patients

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine whether combined intercostal muscle and diaphragm pacing can maintain full-time ventilatory support in patients with ventilatory dependent quadriplegia who are not candidates for phrenic nerve pacing alone. II. Evaluate the efficacy of the Medlink device to produce synchronous intercostal and diagram activation in these patients.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients have a Medlink spinal cord electrode surgically implanted and attached to a radiofrequency receiver implanted subcutaneously over the anterior chest wall. If substantial inspired volumes can be generated by intercostal pacing, a phrenic nerve cuff electrode and radiofrequency receiver are implanted, and patients undergo combined intercostal muscle and diaphragm pacing. Completion date provided represents the completion date of the grant per OOPD records

Conditions
-----------------
Quadriplegia

Intervention / Treatment
-----------------
* Device: Medlink spinal cord electrode


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Ventilator dependent quadriplegics who are not candidates for phrenic nerve pacing alone Must have bilateral partial or unilateral phrenic nerve function Must have been on ventilator support for at least 6 months and unweanable --Patient Characteristics-- Cardiovascular: No active cardiovascular disease Pulmonary: No active lung disease Other: No active brain disease Stable condition

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Medlink spinal cord electrode|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
-----------------
environmental/toxic disorders, neurologic and psychiatric disorders, rare disease, spinal cord injury
Pharmacokinetics of Megace F and Megace OS Under Fasting and Fed Conditions in Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
Phase I study of Megace F will be conducted to investigate pharmacokinetics and safety compared to Megace OS. Phase I study divided into 3 parts written as belows. Part 1 Megace F in fasting volunteers vs Megace F in fed volunteers Part 2 Megace F vs Megace OS in fed volunteers Part 3 Megace F vs Megace OS in fasting volunteers

Official Title
-----------------
A Randomized, Open-label, Single-dose, Cross-over Study to Investigate Safety and Pharmacokinetics of Megace F and Megace OS Under Fasting and Fed Conditions in Healthy Male Volunteers

Conditions
-----------------
Cachexia, Anorexia

Intervention / Treatment
-----------------
* Drug: Megace F
* Drug: Megace OS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age: 20-55 years body weight: greater than 50kg written informed consent Exclusion Criteria: known allergy to Megesterol acute or chronic diseases which could affect drug absorption or metabolism positive drug or alcohol screening smokers of 10 or more cigarettes per day 3 month ago participation in a clinical trial during the last 3 months prior to the start of the study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 Years

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Megace F<br>Megace F oral suspension | Drug: Megace F<br>* Megace F oral suspension<br>|
| Active Comparator: Megace OS<br>Megace acetate oral suspension | Drug: Megace OS<br>* Megace oral suspension<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC |  | 0, 1, 2,3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax |  | 0, 1, 2,3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 hrs | 
| t1/2 |  | 0, 1, 2,3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 hrs |
Genotyping of Metastatic Colorectal Cancer Patients for Precision Medicine Clinical Trials

Study Overview
=================
Brief Summary
-----------------
The goal of delivering the right drug to the right cancer patient (precision medicine) requires a detailed understanding of how genomic alterations are linked to drug response. The purpose of this study is to intercept at point-of-care a large cohort of newly diagnosed mCRC patients to determine if it is possible to obtain personalized genetic information from each subject's tumor (tissue and blood) to triage treatment choices. In case of target positivity, patients will be conveyed, whenever possible, to self-standing, independent, hypothesis-driven POC trials as soon as they exhibit resistance to standard of care treatment.

Official Title
-----------------
Multiplex Genotyping of Metastatic Colorectal Cancer Patients for Precision Medicine Clinical Trials

Conditions
-----------------
Metastatic Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological confirmed adenocarcinoma of the colon or rectum with metastatic disease not amenable to salvage surgery. Planned primary treatment at FUNNEL center or FUNNEL center referring Hospital. Availability of fresh tissue or a paraffin block for genotyping NOT older than 1 year. Age ≥18. ECOG PS 0-1. No major comorbidities that would preclude the potential enrolment of the patient in a clinical trial. Signed informed consent. Exclusion Criteria: Symptomatic brain metastases. Gastro-intestinal abnormalities, inability to take oral medication, any condition affecting absorption. History of another neoplastic disease (except basal cell carcinoma of the skin or uterine cervix carcinoma in situ adequately treated), unless in remission for ≥ 5 years. No major comorbidities that would preclude the potential enrolment of the patient in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Thoroughness to report molecular profiling | Percentage of patients with complete genotyping report produced in less than 14 days after sample acquisition. | 14 days from sample acquisition | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequence of genetic alteration included in the panel detected in 1000 consecutive mCRC | number of patients with detected genetic alteration included in the panel (mutations and/or copy number variations) over all recruited patients. | 24 months from first patient in. | 
| Percentage of complete data capture for treatment-related check-point events |  | through study completion, an average of five years |