linjc16/ctgov huggingface dataset:
Novel Equations for Estimating Lean Body Mass in Patients With Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
Simplified methods to estimate lean body mass (LBM), an important nutritional measure representing muscle mass and somatic protein, are lacking in non-dialyzed patients with chronic kidney disease (CKD). Objective: We developed and tested a reliable equations for estimation of LBM in daily clinical practice.

Detailed Description
-----------------
Two cross-sectional data sets were derived from outpatients with CKD stage 3-5 in Peking University First Hospital.Two equations for estimating LBM based on midarm muscle circumference (MAMC) or hand grip strength (HGS)were developed and validated in CKD patients with dual-energy x-ray absorptiometry (DEXA) as referenced gold method. Demographic data, comorbidity, and other clinical variables were also recorded.

Official Title
-----------------
Novel Equations for Estimating Lean Body Mass in Patients With Chronic Kidney Disease

Conditions
-----------------
Lean Body Mass, Chronic Kidney Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non-dialyzed patients with CKD stage 3-5 clinical stable a willingness to be examined with all measurements being taken simultaneously. Exclusion Criteria: systemic infections, acute cardiovascular events, operations, trauma, active hepatitis or tumor severe edema within one month prior to the study chronic infections, connective tissue disease, hyper- or hypothyroidism, amputations or pregnancy, taking immunosuppressive agents and anti-inflammatory medication chronically

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| development groups<br>The development groups included 150 patients derived from outpatients in Peking University First Hospital, between March 1st, 2014 and November 26th 2014. | |
| validation groups<br>The validation groups included 150 patients derived from outpatients in Peking University First Hospital, between November 27th 2014 and December 1st, 2015. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LBM_DEXA | lean body mass measured by dual-energy x-ray absorptiometry (DEXA) | between March 1st, 2014 and December 1st, 2015 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mid-arm muscle circumference, handgrip strength, dual-energy x-ray absorptiometry
Study on ICU Patients With Nosocomial Lower Respiratory Tract Infections

Study Overview
=================
Brief Summary
-----------------
This is a multicentre, multinational, prospective observational investigation on ICU critically ill patients affected by nosocomial pneumonia, defined as: Out of ICU Hospital-acquired Pneumonia (HAP), Non-ventilator ICU-acquired Pneumonia (NV ICUAP), Ventilator associated pneumonia (VAP) Ventilator associated tracheobronchitis (VAT).

Official Title
-----------------
Epidemiological, Microbiological and Clinical Profile of Ice Patients With Nosocomial Lower Respiratory Tract Infections

Conditions
-----------------
Pneumonia

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Diagnosis of nosocomial pneumonia ICU and HDU admission (patient may be admitted to the ICU with NP or may develop pneumonia during ICU stay) Informed consent (if required) Exclusion Criteria: Community Acquired Infection Absence of Microbiological Findings

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases<br>All ICU patients with nosocomial lower respiratory tract infection | Other: No intervention<br>* No Interventions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients dying among the different pneumonia categories |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with different epidemiological patterns |  | 28 days | 
| Number of patients with specific microbiological profiles |  | 28 days | 
| Number of patients with specific clinical characteristics |  | 28 days | 
| Number of patients with different therapeutically interventions |  | 28 days |
Dose Proportionality and Food Effect of Morphine Sulfate

Study Overview
=================
Brief Summary
-----------------
Establish the dose proportionality of the 15 mg and 30 mg morphine sulfate tablets and to examine the effect of food on absorption from the 30 mg tablet.

Official Title
-----------------
A Single Dose, Three-Period, Three-Treatment, Six-Sequence, Three-Way Crossover Study of the Dose Proportionality of and Effect of Food on Morphine Sulfate Tablets.

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: morphine sulfate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to morphine sulfate or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

| Intervention/Treatment |
| --- |
|Drug: morphine sulfate|morphine sulfate 15 mg and 30 mg tablets|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioequivalence determined by statistical comparison Cmax |  | 15 days |
Laparoscopy in Complicated Groin Hernia

Study Overview
=================
Brief Summary
-----------------
This study assessed the outcomes of laparoscopic repair in complicated groin hernia. Laparoscopic approach in cases of complicated groin hernia can achieve desirable patient outcomes without major complications, provided good patient selection and expertise. This study provides an insight to the outcomes from the procedure in low resource setting of Nepal.

Official Title
-----------------
Outcomes of Laparoscopic Repair in Complicated Groin Hernia: a Single Institutional Based Cohort Study in Nepal

Conditions
-----------------
Inguinal Hernia

Intervention / Treatment
-----------------
* Procedure: laparoscopic repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with age greater than 18 years with diagnosis of complicated groin hernia Exclusion Criteria: Patients with features of peritonitis, history of previous abdominal surgery and those unfit for general anesthesia

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 |
| --- | --- |
| Patients diagnosed with complicated groin hernia<br> | Procedure: laparoscopic repair<br>* All patients of cohort underwent laparoscopic repair.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative complications | 1. Bleeding (epigastric / testicular vessels) 2. Bowel injury 3. Peritoneal tear | during surgical procedure | 
| Postoperative complications | 1. Seroma 2.Urinary Retention 3. Wound infection | upto 6 months post operatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Complicated groin hernia, Totally extra-peritoneal repair, Transabdominal preperitoneal repair
Pharmacokinetic Study in Patients Receiving Posaconazole Therapy in Taiwan

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the factors influencing pharmacokinetic and pharmacodynamic properties of new antifungal agent, posaconazole in Taiwanese patients.

Detailed Description
-----------------
Invasive fungal infection (IFI) may cause high mortality and morbidity in immune- compromised patients. Posaconazole, a new triazole antifungal agent with broad spectrum coverage, was approved for both treatment and prophylaxis of IFIs. Previous studies have demonstrated the relationship between posaconazole plasma concentration and efficacy, thus, the importance of posaconazole therapeutic drug monitoring (TDM) was gradually accepted. However, studies found inter- and intra-individual variation between concentrations, and these phenomenons were affected greatly by GI function, food intake and concomitant medication. Furthermore, there's a lack of posaconazole TDM study in Asian population. The study was designed to describe the prescribing pattern of posaconazole, to study the relationship between concentration and clinical outcomes/ adverse events, to identify factors that influence plasma concentration, and to evaluate whether routine TDM is needed in our institution.

Official Title
-----------------
Pharmacokinetic Study in Patients Receiving Posaconazole Therapy in Taiwan

Conditions
-----------------
Pharmacokinetics, Posaconazole

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving posaconazole therapy Patients aged 13 years old or more Exclusion Criteria: No posaconazole plasma concentration available

Ages Eligible for Study
-----------------
Minimum Age: 13 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 |
| --- | --- | --- |
| Plasma posaconazole concentration |  | 7-10 days after taking posaconazole | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacokinetics, Antifungal Agents
Feasibility and Reproducibility of Barostat Assessments of Colorectal Sensation During Colorectal Distention and Its Pharmacological Modulation Using Octreotide

Study Overview
=================
Brief Summary
-----------------
This study is designed to provide information on feasibility and reproducibility of barostat assessments of colorectal sensory functions and compliance and their pharmacological modulation

Official Title
-----------------
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Crossover Study in Women With Irritable Bowel Syndrome to Evaluate Feasibility and Reproducibility of Barostat Assessments of Colorectal Sensation During Colorectal Distention and Its Pharmacological Modulation Using Octreotide.

Conditions
-----------------
Irritable Bowel Syndrome (IBS)

Intervention / Treatment
-----------------
* Drug: SMS995
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A positive diagnosis of IBS. Subjects must either have been surgically sterilized, hysterectomized at least 6 months prior to screening, be postmenopausal or be using a double-barrier local contraception. Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent Exclusion Criteria: History of or evidence for structural diseases/conditions that affect the gastrointestinal system. Other diseases or conditions that in the opinion of the Investigator significantly affect colorectal sensitivity. Evidence of occult blood at stool analysis, or history of rectal bleeding. Using or planning to use drugs or agents during the study period that alter GI physiology and visceral perception.

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: SMS995<br> <br> * Other names: Octreotide, Sandostatin;|
| Placebo Comparator: 2<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - 5 sensory pressure thresholds [mmHg] from ascending method of limits (AML) barostat protocol. - 16 sensory intensity ratings from the random phasic distention (RPD) barostat protocol. |  | throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - colorectal compliance |  | throughout the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colorectal, Barostat, distention, IBS, irritable, bowel, syndrome, sensation, modulation, reproducibility
Serum Cobalt Status During Pregnancy and the Risks of PIH

Study Overview
=================
Brief Summary
-----------------
The subjects of the present study were from the Ma'anshan Birth Cohort (MABC) study, a prospective pregnancy and birth cohort study designed to examine the relationship between prenatal exposure and pregnant outcomes, child health and development.

Official Title
-----------------
Serum Cobalt Status During Pregnancy and the Risks of Pregnancy-induced Hypertension Syndrome: a Population-based Birth Cohort Study

Conditions
-----------------
Cobalt Deficiency Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women, who were more than 18 years old, around the 14th gestational week Exclusion Criteria: Pregnant women, who were with serious liver or kidney disease, serious cerebrovascular disease, serious mental disease, mental retardation, or unable to complete the study independently

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy-induced hypertension syndrome | The outcome we investigated was physician diagnosed pregnancy-induced hypertensive syndrome, including gestational hypertension, pre-eclampsia, eclampsia, and HELLP syndrome. | through study completion, an average of 1 year |
Termination of Pregnancy With Mifepristone and Misoprostol Versus Sulprostone

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine which medical treatment is the most effective to terminate a pregnancy.

Conditions
-----------------
Abortion, Induced

Intervention / Treatment
-----------------
* Drug: mifepristone
* Drug: misoprostol
* Drug: sulprostone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women by whom a termination of pregnancy is desired. Exclusion Criteria: Women with liver/kidney disease Women on long-term use of corticosteroids (> 6 months) Cardiovascular problems Therapy-resistant diabetic women Therapy-resistant asthma/bronchitis Thalassemia Ulcerative colitis Peptic ulcer disease Glaucoma Porphyria Allergic reaction to prostaglandin or mifepristone Women with a prior caesarian section or women with contractions at the start of the study

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: mifepristone|nan|
|Drug: misoprostol|nan|
|Drug: sulprostone|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
-----------------
termination of pregnancy
Peritoneal Membrane Dysfunction in Peritoneal Dialysis Using Metabolomics

Study Overview
=================
Brief Summary
-----------------
Ability and sensitivity of metabolomics analysis to highlight biomarkers or a score of biomarkers that will be able to identify those pediatric patients on peritoneal dialysis at high risk for possible peritoneal dialysis complications and mainly encapsulating peritoneal sclerosis

Detailed Description
-----------------
Ability and sensitivity of metabolomics analysis to highlight biomarkers or a score of biomarkers that will be able to identify those pediatric patients on peritoneal dialysis at high risk for possible peritoneal dialysis complications and mainly encapsulating peritoneal sclerosis. Identification of peritoneal membrane functional status changes over time, at the same patient (cohort study), by metabolomics, aiming in personalized medicine best practice. Identification of peritoneal membrane functional status changes over time in immature infants' peritoneal membrane. Identification of early and accurate markers of peritoneal membrane dysfunction when membrane status is possibly reversible that could predict peritoneal patients at risk for future loss of ultrafiltration and dialysis adequacy of small molecules examined today be PET, KT/V and Cr/Cl (when membrane status is not reversible). Improve PD survival in infants and children.

Official Title
-----------------
Identification of Early Biomarkers of Peritoneal Membrane Dysfunction in Children on Peritoneal Dialysis Using Metabolomics Analysis

Conditions
-----------------
End Stage Renal Disease, Dialysis

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric and adolescent patients on peritoneal dialysis Aged:1month -20 years Exclusion Criteria: -Abdominal surgery

Ages Eligible for Study
-----------------
Minimum Age: 30 Days
Maximum Age: 20 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no intervention|no interventional study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Peritoneal Equilibration test profile | Peritoneal Equilibration test | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Loss of dialysis adequency | KT/V | 1 year | 
| Elevated creatinine | Creatinine Clearence | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
children, renal failure, dialysis
Evolution of Lymphocyte Populations Under Biotherapy in Inflammatory Bowel Disease

Study Overview
=================
Brief Summary
-----------------
This is a monocentric prospective study for the collection of biological samples (blood and biopsies) to be used for in vitro biomarker assay(s) performed to identify predictive markers of response to biological treatments in inflammatory bowel disease (IBD).

Official Title
-----------------
Evolution of Lymphocyte Populations Under Biotherapy in Inflammatory Bowel Disease

Conditions
-----------------
Inflammatory Bowel Disease

Intervention / Treatment
-----------------
* Biological: sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18 or more. Crohn's Disease Diagnosis (CD) or ulcerative colitis (UC) according to defined criteria (ECCO recommendations). Active disease as defined by clinical biological and/or morphological assessment. Initiation of an anti-Tumor Necrosis Factor (TNF) therapy (Infliximab, Adalimumab, Golimumab) or new biotherapy (Vedolizumab, Ustekinumab) provided in connection with the management of digestive disease. Patient (e) have signed and dated consent of the study before undertaking procedures related to the study. Exclusion Criteria: Patients under guardianship / curators Following Situations Persons unable to understand, read and / or sign an informed consent Patient with the following functions: investigator or co-investigator, research assistant, pharmacist, study coordinator or having any involvement in the study Uncooperative person or potentially non-compliant for the study and its procedures with predictable difficulties regular monitoring of over 1 year. No affiliation to a social security scheme, a universal medical coverage or any similar plan. Pregnant or lactating women.

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 |
| --- |
|Biological: sampling|• Sampling period(s): Blood: W0, W6, W14, W30 and W52 and relapse. Biopsies and fecal: W0, W14 and M52 and relapse.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to biological treatments |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiota variation |  | 12 months |