linjc16/ctgov huggingface dataset:
A Study on the Effect of Renal Impairment on the Pharmacokinetics of RO4917838

Study Overview
=================
Brief Summary
-----------------
This open-label, single-dose, parallel-group study will investigate the pharmacokinetics and safety of RO4917838 in healthy and renal impaired subjects. Subjects will receive a single dose of RO4917838.

Official Title
-----------------
A Multiple Center, Open-label, Single Dose, Parallel-group Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics of RO4917838

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: RO4917838
* Drug: RO4917838


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: General criteria Body mass index (BMI) between 18 and 32 kg/m2 Criteria applying to renal impaired subjects Adult subjects, 18-65 years of age Part 1: Subjects with end stage renal disease (ESRD), not on dialysis Part 2: Subjects with severe, moderate or mild renal impairment Stable renal function Criteria applying to healthy subjects Adult subjects, 18-70 years of age Exclusion Criteria: General criteria Any condition or disease (other than renal impairment for the renal impaired subjects only) that would render the subject unsuitable for the study, or would place the subject at undue risk Any condition which could relapse during or immediately after the study History of alcohol or drug abuse Criteria applying to renal impaired subjects Evidence of unstable clinically significant disease other than renal impairment Clinically significant liver disease Any other major illness (with the exception of renal impairment) within 4 weeks prior to study start Criteria applying to healthy subjects History of any clinically significant disease (e.g., cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic disease)

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Subjects Arm<br> | Drug: RO4917838<br>* Single dose of RO4917838<br>|
| Experimental: Renal Impaired Subjects Arm<br> | Drug: RO4917838<br>* Single dose of RO4917838<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Area under concentration time curve of RO4917838 |  | Days 1-16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | 9 weeks |
Pregnancy Intervention Revolving Around Goal-focused Education (GIRAFE)

Study Overview
=================
Brief Summary
-----------------
The purpose of study is to learn if consuming ≥30 grams or more of fiber per day can help pregnant women gain an appropriate amount of weight during their pregnancy.

Official Title
-----------------
Feasibility of a Single Goal Intervention to Promote Appropriate Gestational Weight Gain

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Behavioral: Dietary Fiber Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women between 9 to 15 weeks pregnant BMI between 22.0 - 40.0 kg/m2 and between the Ages of 18-45 years Able to be recruited from the University of Kansas Medical Center (KUMC). Exclusion Criteria: No Internet access Consuming more than 20 grams per day of fiber And/or with the following medical conditions during pregnancy: Pre-gestational diabetes Diagnosed with diabetes Pre-eclampsia Hypertension Other metabolic abnormalities Asthma Heart disease Smoking Drug abuse Pregnancies of multiples

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Arm<br>Participants were informed to continue to receive usual care by their Obstetrician and were asked to send in body weights weekly. | |
| Experimental: Intervention Arm<br>Received snacks high in fiber, attended weekly phone calls, recorded daily food intake and reported weekly body weight for 12 weeks. | Behavioral: Dietary Fiber Intervention<br>* Intervention included weekly group-based phone counseling with a Registered Dietitian (RD) to encourage consumption of a high fiber diet (≥30 g/day). All women reported their body weight weekly.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of excessive gestational weight gain based on weight gain guidelines. |  | 12-24 weeks gestation and during pregnancy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total gestational weight gain | Measure gestational weight gain (kg) for those women in the intervention arm and control arm. | 12-24 weeks gestation and during pregnancy | 
| Total dietary fiber intake | ≥30 g/day | 12-24 weeks gestation and during pregnancy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dietary Fiber, Gestational weight gain
Treatment of Recent Onset Low Back Pain With Periradicular Injections of Meloxicam

Study Overview
=================
Brief Summary
-----------------
This randomized, double-blind, placebo control, cross-over study tested the hypothesis that periradicular injections of Meloxicam would reduce recent onset low back pain and improve physical activity compared to saline injection at 3 months follow-up evaluation

Detailed Description
-----------------
In the present study we use a well-known non steroidal anti-inflammatory drug, meloxicam, in a novel way, an IM administration near a nerve root.

Official Title
-----------------
Treatment of Recent Onset Low Back Pain With Periradicular Injections of Meloxicam: a Randomized, Double Blind, Placebo Controlled Cross-over Study

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Other: saline
* Drug: Meloxicam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: low back pain from 6 months or less older than 18 years Exclusion Criteria: not able to understand and sign the written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: C-group<br>patients receiving an IM saline injection near the nerve root (periradicular) | Other: saline<br>* The patients received an IM injection of saline near the nerve root (periradicular)<br>|
| Experimental: M-group<br>patients receiving an IM Meloxicam injection near the nerve root (periradicular) | Drug: Meloxicam<br>* The patients received an IM injection of meloxicam near the nerve root (periradicular)<br>* Other names: mobic;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline NRS pain scale score at different consecutive follow up assessments | Patients reported a numeric value to evaluate pain (0= no pain, 10= wrost pain) | 5 minutes, 1, 6, 12 and 24 hours, 1, 5, 15, 30 and 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline level of physical activities and life quality at different consecutive follow up yes/no questionnaire | pain-related insomnia, physical assistance, sport activities, work absence were assessed using a structured questionnaire with dichotomous items (yes/no presence of impairment to the selected item) | 5 minutes, 1, 6,12 and 24 hours, 1, 5, 15, 30 and 90 days |
Potential Diagnostic and Prognostic Value of microRNAs for the Patients of Sepsis-induced Myocardial Injury

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the potential diagnostic and prognosis value of circulating microRNAs compared with cTnI for the patients of sepsis-induced myocardial injury at the emergency department (ED) and intensive care unit (ICU).

Official Title
-----------------
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Conditions
-----------------
Sepsis-induced Myocardial Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of sepsis:SOFA score increase >=2 at baseline level induced by infection. Suspected myocardial injury,including 1 as follows at least:Low blood pressure or using vasoactive drugs; ECG changes(ST segment changes or pathological Q wave); Troponin elevation(> 0.5 μg/L); BNP elevation(> 4670pg/ml); Echocardiography: cardiac function decline(EF<50%). Exclusion Criteria: Skeletal muscle damage (induced by orthopedics, vascular surgery or trauma surgical disease, surgery); Pregnant and lactating women; Patients with mental disorders; Patients are using other experimental drugs; Refusal to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Sepsis-induced myocardial injury group<br>Patients admitted to the hospital with the diagnosis of Sepsis-induced myocardial injury | |
| Blank control group<br>Patients admitted to the hospital without the diagnosis of Sepsis-induced myocardial injury | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic value of microRNAs evaluate by qPCR in patients of sepsis-induced myocardial injury |  | Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prognostic value of microRNAs in patients of sepsis-induced myocardial injury |  | 6 months |
Breastfeeding and Complementary Feeding in Relation to BMI and Overweight

Study Overview
=================
Brief Summary
-----------------
This study examines the associations between different types of infant feeding and BMI and overweight in childhood. The study is based on the Danish National Birth Cohort, established in 1996.

Detailed Description
-----------------
The objective of the study is to examine whether duration of breastfeeding, timing of introduction of complementary food and protein intake at 18 months are associated with BMI and overweight at ages 7 and 11 years, independent of BMI during infancy. Children participating in the Danish National Birth Cohort were followed-up at ages 7 and 11years. Information on infant feeding, protein intake at 18 months, Ponderal Index at birth, child BMI (5 months, 12 months, 7 and 11 years) and several parental factors was available. Path analysis was used to assess the direct and indirect effects of infant feeding on BMI z-scores at ages 7 (n= 36,481) and 11y (n=22,047). Logistic regression analyses were used to examine associations with overweight.

Official Title
-----------------
Breastfeeding and Complementary Feeding in Relation to BMI and Overweight at Ages 7 and 11 Years - a Path Analysis Within the Danish National Birth Cohort

Conditions
-----------------
Child Overweight

Intervention / Treatment
-----------------
* Other: Danish National Birth Cohort


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The women were invited at their first antenatal visit at the general practitioner.Women were included if they intended to carry the pregnancy to term, had a permanent address in Denmark, and spoke Danish well enough to participate in telephone interviews. Exclusion Criteria: Women who were not pregnant.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Danish National Birth Cohort|DNBC is a nationwide cohort study of pregnant women and their offspring. The women were enrolled early during pregnancy between 1996 and 2002. They provided information on exposures during and after pregnancy by means of four computer-assisted telephone interviews in gestational weeks 12 and 30 and post-partum when the child was 6 and 18 months old.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child overweight | The parent reported the height and weight of the children at approximately 7 and 11 years of age. | 2003-2014 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cohort study, Infant feeding, Overweight, Child BMI, Breastfeeding, Intake of protein
Identifiable Factors That May Lead to Postoperative Nausea and Vomiting After Simple Laparoscopic Appendectomy

Study Overview
=================
Brief Summary
-----------------
This is a retrospective chart review meant to identify any factors that are correlated with and may possibly lead to postoperative nausea and vomiting in order to predict need for longer hospital stays and potentially decrease postoperative nausea and vomiting.

Conditions
-----------------
Acute Appendicitis

Intervention / Treatment
-----------------
* Procedure: Appendectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Laparoscopic Simple Appendectomy Uncomplicated surgery Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Appendectomy<br>Patients undergoing a laporascopic appendectomy | Procedure: Appendectomy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative nausea and vomiting |  | During 1st 24 hours post-op |
Comparative Analysis Between Electrical Muscle Activity In Water And Soil

Study Overview
=================
Brief Summary
-----------------
Muscle activity in the aquatic environment was investigated while performing different exercises by electromyography analysis, due to conflicting results in the literature in relation to the floor. This study evaluated and compared the electrical activity of the rectus femoris and biceps femoris, in aquatic method and on the floor, during flexion and knee extension exercises with and without load.

Official Title
-----------------
COMPARATIVE ANALYSIS BETWEEN THE ELECTRICAL ACTIVITY WITH AND WITHOUT MUSCULAR STRENGTH IN WATER AND SOIL

Conditions
-----------------
Healthy Individuals.

Intervention / Treatment
-----------------
* Other: Heated pool training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 to 35 Sedentary (who engage in physical activity more than twice a week). Exclusion Criteria: History of pain, trauma and / or surgery on the knee joint; Presence of musculo - skeletal

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: heated pool<br>After selection, all volunteers will be asked to attend two exercise protocols performed on the ground and in the heated pool and the minimum interval of 24 hours between each protocol. Data collection will be performed only with the dominant member of each volunteer. | Other: Heated pool training<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COMPARATIVE ANALYSIS BETWEEN THE ELECTRICAL ACTIVITY WITH AND WITHOUT MUSCULAR STRENGTH IN WATER AND SOIL | It is believed that there is a decrease in muscle electrical activity following the exercises without resistance in the heated water in comparison with cold water and soil due to muscle relaxation and a reduction of the viscosity of water. Considering the resistance exercises, it is believed that there is an increase in muscle electrical activity when held in cold water in comparison with heated water and soil due to the increased viscosity of water. | April-October 2013 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy
Mottling Score and Central Venous Oxygen Saturation in Septic Shock Patients

Study Overview
=================
Brief Summary
-----------------
Mottling score and central venous oxygen saturation are described as a clinical evaluation of tissue perfusion. This study describes mottling incidence and mottling score in septic shock patients according to central venous oxygen saturation.

Detailed Description
-----------------
This study prospectively analyzed the data of patients admitted to our ICU between October 2022 to December 2022. All septic patients in whom the ScvO2 was measured and mottling scores were evaluated were included. This study enrolled patients aged ≥ 18 years in septic shock. Those excluded have peripheral arterial disease, black skin, cutaneous infection of the lower limbs, pregnancy, and relative refusal. The characteristics of patients were recorded at admission (H0), including demographics (age, sex, body mass index (BMI), admission the Acute Physiology and Chronic Health Evaluation (APACHE II) score, Glasgow Coma Scale (GCS) and sequential organ failure assessment (SOFA) score. Variables such as plasma lactate level, daily urine output, plasma creatinine level, the ratio of arterial oxygen pressure related to inspired oxygen fraction (PaO2/FiO2), hemoglobin level, heart rate, mean arterial pressure, pulsatile saturation in oxygen (SpO2) and body temperature were recorded at H0 and 6 hours after initial resuscitation (H6).

Official Title
-----------------
Mottling Score and Central Venous Oxygen Saturation in Septic Shock Patients

Conditions
-----------------
Central Oxygen Saturation, Microcirculation, Mottling Score, Septic Shock

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients aged ≥ 18 years in septic shock. Exclusion Criteria: patients having the peripheral arterial disease black skin, cutaneous infection of the lower limbs pregnancy relative refusal

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 |
| --- | --- | --- |
| Difference in mottling incidence according to ScvO2 level during a septic shock. |  | at 0th hour, admission; at 6th hour after initial treatment | 
| Difference in mottling score according to ScvO2 level during a septic shock. | 0 score is minimum level, meaning no mottling, meaning better outcome 5 score is maximum level, meaning more mottling, meaning worse outcome | at 0th hour, admission; at 6th hour after initial treatment |
The Effects of Linezolid and Vancomycin on Inflammation and Cellular Signaling Vents

Study Overview
=================
Brief Summary
-----------------
We will determine if linezolid inhibits cellular activation and production of pro-inflammatory cytokines, providing mechanistic rationale for its clinical efficacy and the justification for further investigations in S. Aureus sepsis.

Official Title
-----------------
The Effects of Linezolid and Vancomycin on Inflammation and Cellular Signaling Vents

Conditions
-----------------
Sepsis

Intervention / Treatment
-----------------
* Drug: Linezolid or Vancomycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, taking no medications, and not recently hospitalized Exclusion Criteria: Infection (active)

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Heathy Subjects<br> | Drug: Linezolid or Vancomycin<br>* Whole blood samples from healthy subjects will be incubated with MRSA bacterium or bacterial toxins in the presence and absence of either linezolid or vancomycin. Final concentrations will mimic physiologic conditions. Platelets and leukocytes will be isolated and assayed for the presence of absence of activation and pre-mRNA splicing.<br>* Other names: Zyvox;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IL-6 | Measurement of IL-6 release in response to MRSA. | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MCP-1 | Measurement of MCP-1 release in response to MRSA. | 12 Months |