linjc16/ctgov huggingface dataset:
Characterization of Cleft Lip and Palate Conditions in Guatemala

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare types of and risk factors for cleft lip and palate in a Guatemalan population to a United States population.

Detailed Description
-----------------
Demographic, surgical, and cleft type data from US patients were gathered via chart review of the electronic medical record. Data from Guatemalan patients was gathered orally from patient caregivers in their native language. Consent was also given orally in the caregivers native language. All data was de-identified prior to analysis.

Official Title
-----------------
Comparison of Cleft Lip and Palate Between a United States Tertiary Care Center and a Guatemalan Surgical Mission: A Cohort Study of 629 Pediatric Patients and a Survey of Risk Factors

Conditions
-----------------
Cleft Lip, Cleft Palate, Cleft Lip and Palate

Intervention / Treatment
-----------------
* Other: NA - survey instrument


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of isolated cleft lip and/or palate scheduled for cleft-related surgery at either the Children's Hospital of Philadelphia or Smiles for Guatemala during the previously described time frames Exclusion Criteria: diagnosis of a recognized medical syndrome medically complex defined as having major medical problems in three or more organ systems diagnosis of isolated midline cleft lip diagnosis of Tessier facial cleft greater than 18 years of age

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum 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 |
| --- | --- |
| CHOP (US)<br>Children with isolated cleft lip and/or cleft palate scheduled for surgery between 2012 to 2019 at the Children's Hospital of Philadelphia, Philadelphia, PA, USA. | |
| SFG (Guatemala)<br>Children with isolated cleft lip and/or cleft palate scheduled for surgery between 2017 and 2020 with Smiles for Guatemala, Guatemala City, Guatemala. | Other: NA - survey instrument<br>* Survey instrument was administered verbally to parents of the Guatemalan cohort.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cleft phenotype | Presence, laterality, and completeness of cleft lip and/or palate as classified by the LAHSHAL system, data gathered by physical exam | pre-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cleft risk factors | Presence of potential risk factors for cleft lip and palate such as maternal exposures during pregnancy, data gathered by interview with caregivers | during the surgery | 
| Surgical care | Type of surgery scheduled and patient age at time of scheduled surgery, data gathered by chart review | pre-surgery |
Investigation on the Dynamic Changes in Air Microbiome in Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
The microbiome of ICU, especially the air microbiome of ICU is not clear. The relationship between the microbiome of ICU and the hospital- acquired infection needs to be clarified. In this study, we try to outline the dynamic changes of microbiome in ICU and give some advice on the prevention of HAI.

Official Title
-----------------
Investigation on the Dynamic Changes in Air Microbiome in Intensive Care Unit

Conditions
-----------------
Hospital Acquired Infection

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: no patients were enrolled in this study. Exclusion criteria: no patients were enrolled in this study.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| open<br>open: open ICU | Other: no intervention<br>* No intervention<br>|
| negative<br>negative: negative-pressure laminar flow ward | Other: no intervention<br>* No intervention<br>|
| positive<br>positive: laminar flow ward | Other: no intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Community of microbiome in ICU | the dynamic changes of metagenomic/16s sequencing data | 1 year and a half | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Microbial Colonization, Environmental Exposure, Microbiome
Treatment of Peripheral Neuropathy in Patients With Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this protocol is to determine if an investigational drug is effective in treating nerve malfunction in diabetes.

Official Title
-----------------
LY333531 Treatment of Peripheral Neuropathy in Patients With Diabetes

Conditions
-----------------
Diabetic Neuropathies, Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Ruboxistaurin mesylate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have type I or type II Diabetes Mellitus. Have been clinically diagnosed with neuropathy. Have an HbA1C less than or equal to 12%. Patients with HbA1C greater than 9% must be on insulin therapy. Must be 18 years or older. Be able to visit the doctor's office approximately 3 times over a maximum of a 6-week period to determine if you can continue in the study. Exclusion Criteria: History of significant liver problems. Have poor kidney function. Drink an excess of alcohol or abuse drugs. Have recently participated in or are currently participating in a Medical study in which you receive an experimental drug. Are a woman and are pregnant or breastfeeding, intending to become pregnant within the next 2 years, or are a woman not using an effective method of birth control.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ruboxistaurin mesylate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in the progression of DPN measured by composite score |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vibration sensation;Electrophysiology of tibial, peroneal and sural nerves;Neurological signs;Neuropathic symptoms;Clinical global impression of change;Health outcome measures |  |  |
Single Patient Use of Selinexor and Dexamethasone for a Patient With Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
This is an individual patient, expanded access protocol using Selinexor and dexamethasone (Sd) for the treatment of Relapsed, Refractory multiple myeloma in a 64 year old male, 19023-UMN-01 weighing 105.7 kg. 19023-UMN-01 has IgG kappa myeloma that has relapsed after numerous treatments.

Detailed Description
-----------------
Selinexor is an oral, first in class, slowly reversible, potent and Selective Inhibitor of Nuclear Export (SINE) compound that specifically blocks Exportin 1 (XPO1). It is one of the most promising investigational drugs available for this patient with clear risk and benefit assessment favoring potential benefit.

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: Selinexor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients having relapsed/refractory multiple myeloma and neuropathy (or who are otherwise unable to tolerate bortezomib) Aged 18 years and older Patient able to provide written, informed consent to participate in and follow the KEAP Treatment Plan Exclusion Criteria: Known hypersensitivity to selinexor or any excipients. Patient receiving any other investigational agent. Any concurrent uncontrolled and active medical condition or disease (e.g., uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection, etc.). Known intolerance, hypersensitivity, or contraindication to glucocorticoids. Active graft versus host disease (after allogeneic stem cell transplantation). Active, unstable cardiovascular function: Symptomatic ischemia, or uncontrolled clinically significant conduction abnormalities (e.g., patients with ventricular tachycardia on antiarrhythmics) Congestive heart failure of New York Heart Association Class ≥ 3 or known leftventricular ejection fraction < 40%, or Myocardial infarction within 3 months prior to C1D1. Significant renal impairment with ongoing dialysis treatment Active gastrointestinal dysfunction interfering with the patient's ability to swallow tablets, or any active gastrointestinal dysfunction that could, in the treating physician's opinion, interfere with absorption of treatment. Any active, serious psychiatric, medical, or other conditions/situations which, in the treating physician's opinion, could compromise the patient's safety.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Selinexor|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
-----------------
MM
Strain Echocardiography During Septic Shock : an Observational Pilot Study

Study Overview
=================
Brief Summary
-----------------
The mortality of septic shock remains high nowadays despite a trend toward improvement.Septic cardiomyopathy has been reported in most experimental models of sepsis shock. Its relationship with mortality is unclear. A decrease in mortality have been reported in patients with decreased left ventricular ejection fraction (LVEF), but a recent meta-analysis did not support such results. In fact, it appears that high LVEF are linked to profound vasoplegia which is associated to bad outcome. In the other hand, alterations of Strain echocardiography, a new method allowing a more sensitive evaluation of heart function, have been associated with a worse outcome in sepsis patients. Only few studies have examined echocardiographic strain during sepsis shock in human, and its natural history was only described in pigs. Moreover, the right ventricular strain was reported only by Orde et al whereas the evolution of strain during fluid infusion have never been studied. The aim of the present study is to describe the natural history of echocardiographic strain during sepsis shock and to determine its prognosis value.

Official Title
-----------------
Strain Echocardiography During Septic Shock : an Observational Pilot Study

Conditions
-----------------
Shock, Septic, Echocardiography

Intervention / Treatment
-----------------
* Device: strain echocardiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Septic shock (suspected or proven infection and norepinephrine ≥ 0,25µg/kg/min) Inclusion within the first 24h of septic shock Exclusion Criteria: Patient < 18 year of age Pregnant women History of myocardial infarction, valvular disease, atrial fibrillation

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: strain echocardiography|strain echocardiography during septic shock|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global peak systolic longitudinal strain assessed by echocardiography. Global peak systolic longitudinal strain |  | up to 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU mortality | On the day of patient discharge from the ICU | up to 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
strain, Shock, Septic, Echocardiography, speckle tracking
Fructose Malabsorption in Northern Norway

Study Overview
=================
Brief Summary
-----------------
Different published studies has shown a possible co-variation between leakage of fructose to the great bowel and exacerbation of irritable bowel syndrome (IBS) symptoms. The aim of the FINN trial is to study the role of fructose malabsorption in patients with IBS in order to evaluate different diagnostic criteria for fructose malabsorption and at the same time study the effect of diet treatment in this cohort of patients and estimate the prevalence of fructose malabsorption.

Official Title
-----------------
Fructose Malabsorption in Northern Norway. Fructose Malabsorption and Irritable Bowel Syndrome.

Conditions
-----------------
Irritable Bowel Syndrome, Fructose Malabsorption

Intervention / Treatment
-----------------
* Behavioral: diet restriction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IBS patients satisfying ROME 2 diagnostic criteria Exclusion Criteria: Seriously ill Organic abdominal disease Other functional bowel disease

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>PATIENTS IN THIS ARM IS INSTRUCTED IN FRUCTOSE REDUCED DIET FOR A PERIOD OF 3 MONTHS | Behavioral: diet restriction<br>* each meal should contain less than 2 gm fructose<br>|
| No Intervention: 2<br>these patients use their usual diet | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS score og specific abdominal complaints.SGA score of relief related to abdominal complaints. |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate sensitivity,specificity,negative and positive predictive value using 50 gm fructose in breath test.Validate questionary for intolerance.Validate VAS in judging changes in abdominal complaint.Examine polymorphism i Glut5 transporter gene. |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fructose, Irritable bowel syndrome, malabsorption, Glut5 transporter gene
Health Economics Evaluation of the Management of Severe Postpartum Hemorrhage: Comparison of Recombinant Activated Factor VII Strategy to the Reference Strategy

Study Overview
=================
Brief Summary
-----------------
The main objective of this project is to assess the average cost of the treatment of bleeding postpartum with recombinant activated factor VII (NovoSeven®) and compare it to the reference strategy. Costs related to medicine NovoSeven® can generate surplus, but it also avoids in some cases very costly invasive procedures. It will be interesting to compare the average cost of the complete strategies supported.

Conditions
-----------------
Health Care Cost, Post Partum Haemorrhage

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe haemorrhage is defined by the following criteria: blood loss greater than 1500 ml graduated measured in the bag and / or hemodynamically unstable and / or requiring transfusion of packed red blood cells (3); Sulprostone (Nalador®) ineffective; Age over 18 years; The term is more than 27 SA (child's viability); Without anthropomorphic limit; The outcome of the pregnancy is normal or pathological; Informed consent emergency procedure is signed by the husband or family. Exclusion Criteria: minors, majors in guardianship, with a personal history of venous or arterial thrombosis may cons-indicate treatment with rFVIIa or refuses to sign the consent

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 |
| --- | --- |
| recombinant activated factor VII (NovoSeven®)<br>Group using the Novoseven | |
| Standard care<br>without use of the Novoseven | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| direct medical cost |  | day 1 |
SALTO - Epidemiological Study on Compliance and Treatment Satisfaction

Study Overview
=================
Brief Summary
-----------------
Patients that are on total knee/hip replacement initiate prophylaxis treatment on the hospital ground. Once they leave the hospital, as outpatients they continue with the treatment at least during two consecutive weeks. Patients will be instructed to follow treatment recommendations (either LMWH or oral treatment, at physician discretion) and to come back to the surgeon after that period. At that visit, the Treatment Satisfaction Questionaire with Medication (TSQM) test as well as the Moriski-Green Questionaire (measures compliance with medication) will be answer by the patient. TSQM is an self administered validated scale (validated also in spanish) that measures in a generic way the treatment satisfaction to a treatment. Morinski-Green test will be used to measure the compliance degree on medication.

Official Title
-----------------
Compliance and Treatment Satisfaction in Prophylaxis of Postsurgical Thromboembolism

Conditions
-----------------
Thromboembolism

Intervention / Treatment
-----------------
* Behavioral: No Drug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in antithrombotic prophylaxis treatment after total knee/hip replacement. This is an epidemiological study where the patients to be included will be those that are treated with antithrombotics as out-patients in real life conditions. Exclusion Criteria: Patients who has been previously treated with injectable antithrombotic treatments. Diabetic patients treated with insulin. Patients who do not sign Informed Consent Form.

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 |
| --- | --- |
| Group 1<br> | Behavioral: No Drug<br>* Patients in daily life clinical treatment receiving pharmacological agents to prevent VTE.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the Treatment Satisfaction with medication through the self administered scale TSQM. |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure compliance with medication and the relationship with satisfaction through the Moriski-Green Questionaire |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arthroplasty, Antithrombotic prophylaxis treatment, Replacement, Knee
The Role of Tuberculosis in Chronic Obstructive Lung Disease

Study Overview
=================
Brief Summary
-----------------
Influence of tuberculosis (TB) on natural course of chronic obstructive lung disease (COPD) has not been well known. This study was designed to investigate the effects of history of TB on the long-term course of COPD.

Detailed Description
-----------------
Patients hospitalized with COPD exacerbation were consecutively included (n=598). Cases were classified into two categories: those with a history of TB and those without. Clinical, demographic, and radiological features were meticulously recorded and patients were followed up for mortality. 93 patients (15%) had past TB. On average, patients with a history of TB were four-year younger (p=0.002). Our study revealed that patients with TB history were diagnosed with COPD five-year earlier and died five-year earlier as compared to the patients without TB. In addition, in the TB history positive group, the rate of hospital admissions per year was higher compared to the group that lacked TB history (2.46±0.26 vs. 1.56±0.88; p=0.001). The patients with TB history had higher PaCO2 and lower FEV1 (p=0.008 and p=0.069 respectively). Median survival was 24 months for patients with past TB, and was 36 months for those without. Kaplan-Meier analysis revealed that although 3-year survival rate was lower in patients with TB history, it was not statistically significant (p=0.08). Cox regression analysis showed that while factors such as age, PaCO2, hematocrit, BMI and the Charlson index affected mortality rates in COPD patients (p<0.05), prior history of TB did not seem to have a significant impact on the mortality. Our results showed that past TB caused more hospitalizations, lower respiratory functions and higher arterial carbon dioxide levels. It was found that, though the mortality rates were similar, COPD patients with past TB was diagnosed and died five-year earlier. We conclude that history of TB has an important role in natural course of COPD.

Official Title
-----------------
The Role of Tuberculosis in Chronic Obstructive Lung Disease

Conditions
-----------------
The Role of Tuberculosis in COPD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being diagnosed with COPD exacerbations Exclusion Criteria: Not diagnosed with COPD exacerbations

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| with history of TB<br> | |
| without history of TB<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality |  | three years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, tuberculosis, mortality