linjc16/ctgov huggingface dataset:
Iron Dosing Pilot Study Using Model Predictive Control

Study Overview
=================
Brief Summary
-----------------
This is a pilot study to test the utility of an integrated approach in the management of the anemia of chronic kidney disease through the administration of both an erythropoietic stimulating agent and iron. Subjects will be studied for 6 months during which all iron dosing will be recommended using a computer based tool using model predictive control. Comparisons will be made to the 6 months prior to enrollment in to the study.

Official Title
-----------------
Iron Dosing Pilot Study Using Model Predictive Control

Conditions
-----------------
Renal Insufficiency, Chronic, Anemia, Iron Deficiency, Anemia of Chronic Kidney Disease

Intervention / Treatment
-----------------
* Device: Model predictive control
* Device: Model Predictive Control of Iron Dosing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic kidney disease anemia receiving intravenous iron Exclusion Criteria: none

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Model predictive control recommendation of iron dosing in combination with an erythropoietic stimulating agent. | Device: Model predictive control<br>* Computer aided dose selection for the treatment of iron deficient anemia.<br>Device: Model Predictive Control of Iron Dosing<br>* Model Predictive Control of Iron Dosing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of tsat values within range | Tsat is measured as a percent saturation, desired range is 20 to 50% | Monthly for 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Iron dose over ride by physician | Number of recommended iron doses that the prescribing physician altered. | Monthly for 6 months |
Use of Blood Biomarkers and Biomarker Index to Aid in the Diagnosis of Obstructive Sleep Apnea (OSA)

Study Overview
=================
Brief Summary
-----------------
This multicenter prospective trial will evaluate the association between obstructive sleep apnea (OSA) and blood biomarkers in a representative population of consecutively enrolled symptomatic patients with a clinical suspicion of OSA.

Official Title
-----------------
Use of Blood Biomarkers and Biomarker Index to Aid in the Diagnosis of Obstructive Sleep Apnea (OSA)

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Diagnostic Test: blood biomarker


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written Informed Consent Male 18-70 years old Presentation with symptoms suggestive of obstructive sleep apnea Diagnostic sleep study Blood draw Exclusion Criteria: Prior (within past year) or current therapy for sleep apnea Use of opioid pain medication, steroids or allopurinol (within past 30 days) Use of chronic anti-inflammatory drugs (within past 7 days) Active cancer under current treatment or monitoring

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OSA<br>Blood biomarker results in subjects with obstructive sleep apnea. | Diagnostic Test: blood biomarker<br> <br> |
| Non-OSA<br>Blood biomarker results in subjects without obstructive sleep apnea | Diagnostic Test: blood biomarker<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of OSA in high-risk individuals | Identification of OSA in high-risk individuals | 1 day |
Single Anastomosis Sleeve Iejenal Bypass in Obese Patient With Hiatus Hernia

Study Overview
=================
Brief Summary
-----------------
single anastomosis sleeve jejunal bypass with hiatal repair for morbid obesity with reflux manifestations

Detailed Description
-----------------
preoperative endoscopy was done and if hiatus hernia was present the patient is undergo single anastomosis sleeve jejunal bypass with hiatal repair for morbid obesity with reflux manifestations

Official Title
-----------------
Single Anastomosis Sleeve Iejenal Bypass With Crural Repair in Obese Patient With Hiatus Hernia

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

Intervention / Treatment
-----------------
* Other: Single anastomosis sleeve jejunal bypass with hiatal repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity patients fit for laparoscopic surgery give approval to share in the study Exclusion Criteria: patients refused to share in the study patients unfit for surgery patients aged less than 18 and older than 60 patient with previous upper abdominal surgery either for obesity or other diseases revisional bariatric procedures

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Experimental: Single anastomosis sleeve jejunal bypass with hiatal repair<br>Single anastomosis sleeve jejunal bypass with hiatal repair | Other: Single anastomosis sleeve jejunal bypass with hiatal repair<br>* Single anastomosis sleeve jejunal bypass with hiatal repair<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the effect of sleeve jejunal bypass on reflux manifestations | evaluation of the effect of sleeve jejunal bypass on reflux manifestations | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EWL | excess weight loss at one year | one year | 
| treatment of comorbidities | effect on obesity comorbidities | one year |
Energy Load in Patients With Acute Respiratory Distress Syndrome (ARDS)

Study Overview
=================
Brief Summary
-----------------
The investigator would assess if there is an incremental energy load during mechanical ventilation in Acute Respiratory Distress Syndrome (ARDS) patients.

Detailed Description
-----------------
The investigator would study the inspiratory and expiratory pressure volume curve in ARDS patients and investigate if there is a correlation between the energy loss (hysteresis curve) and the severity of disease.

Official Title
-----------------
Energy Load During Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome (ARDS)

Conditions
-----------------
Acute Respiratory Distress Syndrome (ARDS)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ARDS patients Exclusion Criteria: pediatric population Chronic Obstructive Pulmonary Disease (COPD) patients with hemodynamic instability

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 |
| --- | --- |
| ARDS<br>Mechanically ventilated patients with Acute Respiratory Distress Syndrome | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Association between energy load provided to the lung during mechanical ventilation and mortality during ICU stay | Two weeks (average ICU stay) |
Assessment of Pain and Quality of Life in Breast and Prostate Cancer Patients With Bone Metastases

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety, tolerability and efficacy of zoledronic acid administered intravenously every 3-4 weeks in patients with bone metastases from either breast cancer or prostate cancer.

Official Title
-----------------
A Multicenter, Open-label Study to Determine the Effect of iv. Zoledronic Acid on Pain and Quality of Life in Patients With Bone Metastases With or Without Skeletal Related Events (SRE) Resulting From Breast Cancer and Prostate Cancer

Conditions
-----------------
Neoplasm Metastasis

Intervention / Treatment
-----------------
* Drug: Zoledronic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Ambulatory patients >18 years Proof of breast cancer or prostate cancer Diagnosis of at least one cancer-related bone lesion that is detectable on conventional radiographs or bone scan at screening Negative pregnancy test ECOG performance status of 0,1 or 2 Exclusion criteria: Patients with abnormal renal function Patients with clinically symptomatic brain metastases Known hypersensitivity on zoledronic acid or other bisphosphonates Pregnancy or lactation Other protocol-defined inclusion/exclusion criteria may apply.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ZOL446<br> | Drug: Zoledronic acid<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of pain assessed by a Visual Analogue Scale (VAS) |  | throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life assessment at baseline and last visit |  | throughout the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, Metastasis, Neoplasm, pain, prostate cancer, bone metastasis
Attention Training

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to understand whether attention training is effective in moderating mind wandering.

Detailed Description
-----------------
Our subjective worlds are built from those things in our internal and external environments that capture our attention. Environments can be ambiguous with respect to which objects are most important for our attention, and the characteristics of stimuli that allow them to dominate attention are thus of great interest. Self-relevant objects, such as internally generated experience (e.g. thought), may receive substantial attention, but research on this dimension has been hampered by the difficulty of measuring such objects experimentally. The proposed study seeks to make headway in this area using several behavioral (accuracy, response time, response pattern) measures, with the hypothesis that internally generated experience will vie for attention in a way reflected by behavior. Such research will extend previous work the investigators' lab has done studying stimulus parameters that influence attention, and as a whole may present a more complete picture of how objects and attention interact to shape our worlds.

Official Title
-----------------
Attention Training

Conditions
-----------------
Attention

Intervention / Treatment
-----------------
* Behavioral: breath attention training
* Behavioral: working memory attention training


Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria: Non-English speakers Inclusion Criteria: Must be able to use a computer

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: breath attention training<br> | Behavioral: breath attention training<br>* 4 week training<br>|
| Active Comparator: working memory attention training<br> | Behavioral: working memory attention training<br>* 4 week training<br>|
| No Intervention: no training<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in mind wandering frequency after intervention | mind wandering will be assessed with self-report to intermittent queries such as just now, was your attention on the present task or unrelated concerns? Frequency of endorsement will serve as a measure of frequency of mind wandering (ranging in units from 0 - 100% of the time). | before intervention and up to 100 weeks later |
The Forensic Psychiatric Nurse - Warden or Empathic Caregiver

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine whether the work environment influences the role perception of nurses in psychiatric wards. This will be a comparative study. Questionnaires will be distributed to nurses working in psychiatric wards in 10 medical centers in Israel.

Conditions
-----------------
Psychiatric Nursing

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: RN Accredited Nurses Hebrew Speaking Exclusion Criteria: Incomplete questionnaire

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 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 |
| --- | --- |
| Forensic Psychiatric Nurses in Mental Health Centers<br>Psychiatric nurses working in forensic wards in mental health centers | Other: Questionnaire<br>* Questionnaires will be distributed to nursing staff<br>|
| Psychiatric Nurses in General Hospitals<br>Psychiatric nurses working in general hospitals | Other: Questionnaire<br>* Questionnaires will be distributed to nursing staff<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Empathetic Caregiver | Questionnaire with Liekert Scale will determine nursing staff behavioral intention | One year | 
| Warden | Questionnaire with Liekert Scale will determine nursing staff behavioral intention | One year |
DZX Mediated Insulin Suppression in Obese Men

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether there is an additive effect of metformine on the weight reduction of obese hyperinsulinemic men who are treated with diazoxide.

Official Title
-----------------
Diazoxide-mediated Insulin Suppression in Hyperinsulinemic Obese Men, Part III

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

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Diazoxide
* Drug: Metformin + Diazoxide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male age 25-50 years BMI 30-35 kg/m2 stable body weight during 3 months before the start of the study glucose <= 6.0 mmol/L C-peptide >= 1.0 nmol/L HbA1c <= 6.0% Exclusion Criteria: comorbidity medication serum creatinine > 120 micromol/L liver enzymes > 2 times upper limits of normal gout alcohol use > 2 alcoholic drinks a day drug abuse cessation of smoking less than 6 months ago

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo | Drug: Placebo<br> <br> |
| Experimental: 2<br>Diazoxide | Drug: Diazoxide<br> <br> |
| Experimental: 3<br>Metformin + Diazoxide | Drug: Metformin + Diazoxide<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, hyperinsulinism, diazoxide, metformin
Effects of a Fortified Dietary Supplement for Pregnant Women on Maternal and Newborn Outcomes in Kampong Chhnang Province, Cambodia

Study Overview
=================
Brief Summary
-----------------
The study will evaluate the effects of a nutrition supplement for pregnant women on birth weight and other outcomes. The hypothesis is pregnant women who consume a daily fortified food supplement will produce babies with a higher mean birth weight than those who do not.

Official Title
-----------------
Effects of a Fortified Dietary Supplement for Pregnant Women on Maternal and Newborn Outcomes in Kampong Chhnang Province, Cambodia

Conditions
-----------------
Maternal and Newborn Health

Intervention / Treatment
-----------------
* Dietary Supplement: Corn Soya Blend+


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 18 years of age in first trimester of pregnancy plans to reside in the same village during the entire pregnancy Exclusion Criteria: a minor not in first trimester of pregnancy plans to relocate during the pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 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 |
| --- | --- |
| Experimental: Dietary supplement<br>Pregnant women in 37 villages. | Dietary Supplement: Corn Soya Blend+<br>* A blended food consisting of corn (75-80%) and soybeans (20-25%) that has been fortified with a premix of 19 vitamins and minerals.<br>|
| No Intervention: Control group<br>Pregnant women in 38 villages | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean birth weight |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean gestational weight gain |  | 9 months | 
| Mean maternal hemoglobin level |  | 9 months | 
| Mean birth length and head circumference |  | 9 months |
Study on FOLFOX6 as First-line Therapy to Treat Recurrent or Metastatic Esophageal Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to explore whether FOLFOX6 as treatment could improve the time to progression (TTP) and overall survival (OS) of the patient with recurrent or metastatic esophagus.

Detailed Description
-----------------
Explore whether FOLFOX6 as treatment could improve the TTP and OS of the patient with recurrent or metastatic esophagus

Official Title
-----------------
Phase II Study on FOLFOX6 as First-line Therapy to Treat Recurrent or Metastatic Esophageal Cancer

Conditions
-----------------
Esophageal Squamous Cell Carcinoma

Intervention / Treatment
-----------------
* Drug: FOLFOX6


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven primary thoracic esophageal squamous cell carcinoma Without chemotherapy or neo-adjuvant chemotherapy in 6 weeks ,radiotherapy has end at least 1 month,target lesion was not in an irradiated area. Presence of at least one index lesion measurable by CT scan or MRI 18 75 years kps ≥ 70 Life expectancy of ≥ 3 months ANC ≥ 2×109/L，PLT ≥ 100×109/L，Hb ≥ 90g/L Cr ≤ 1.0×UNL TB ≤ 1.25×UNL； ALT/AST ≤ 2.5×UNL，THE patient with liver metastasis ALT/AST ≤ 5.0×UNL；AKP ≤ 2.5×UNL Signed written informed consent Exclusion Criteria: Previous exposure to oxa therapy in one year diameter of tumor abdominal ≥ 10cm, Total volumes of liver lesions ≥ 50%,lung metastasis ≥ 25% total lung chronic diarrhea,enteritis,intestine obstruction which are not under control Psychiatric or addictive disorders that preclude obtaining informed consent or adherence to protocol. peripheral neuropathy ≥ CTCAE 1 Other serious disease Previous or concomitant malignancies except non-melanoma skin cancer, carcinoma in situ of the cervix, and invasive carcinoma of the colon, thyroid, cervix, or endometrium treated five years prior to study entry. USE OTHER ANTITUMOR THERAPY Breast-feeding or pregnant women, no effective contraception if risk of conception exists

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FOLFOX6<br> | Drug: FOLFOX6<br>* OXA 100mg/m2 ivgtt 2h d1 LV 400mg/m2 ivgtt 2h d1 5FU 400mg/m2 iv. d1 5FU 2.4g/m2 civ 46h<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TPP |  | from the first cycle of treatment (day one) to two month after the last cycle | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS |  | from the first cycle of treatment (day one) to two month after the last cycle |