linjc16/ctgov huggingface dataset:
Occurrence of Pneumocystis Pneumonia in HIV-Infected Patients and the Interference of the HAART

Study Overview
=================
Brief Summary
-----------------
From the beginning of the AIDS epidemic, pulmonary pneumocystosis (PCP) has been distinguished as one of the most frequent opportunistic diseases with high morbid-mortality. As from 1996, the advent of the highly active antiretroviral therapy (HAART) has changed the characteristics of such epidemic by reducing its related diseases and, as a result, AIDS-related mortality. With the purpose to estimate PCP occurrence and HAART interference, 376 HIV-infected or AIDS patients were studied from January 1992 to December 2002.

Detailed Description
-----------------
From the beginning of the AIDS epidemic, pneumocystis pneumonia (PCP) has been distinguished as one of the most frequent opportunistic diseases with high morbid-mortality. As from 1996, the advent of the highly active antiretroviral therapy (HAART) has changed the characteristics of such epidemic by reducing its related diseases and, as a result, AIDS-related mortality. With the purpose to estimate PCP occurrence and HAART interference, 376 HIV-infected or AIDS patients were studied from January 1992 to December 2002. Among them, 58 (15.5%) PCP cases were found. There was a higher occurrence of PCP in the group of patients in which HAART was not used, with 40 (69.0%) of the episodes. As regards the studied period, a tendency to a linear reduction in annual PCP incidence was observed. The mean of T CD4+ lymphocytes in the patients with PCP (117 cells/mm3) was significantly lower when compared to that of the other individuals (325 cells/mm3). Therefore, this study suggests a temporal reduction in PCP occurrence related to HAART use with higher T CD4+ lymphocyte counts. Nevertheless, this opportunistic infection still shows significant incidence in AIDS patients.

Official Title
-----------------
Occurrence of Pneumocystis Pneumonia in HIV-Infected Patients and the Interference of the Highly Active Antiretroviral Therapy

Conditions
-----------------
HIV

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV infection Exclusion Criteria: No HIV infection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| no HAART<br>Patients that no received HAART | |
| with HAART<br>Patients that received HAART | |

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
-----------------
Pneumocystis Pneumonia, Acquired Immune Deficiency Syndrome, Highly Active Antiretroviral Therapy, Treatment Experienced, Treatment Naive
Adherence Intervention for Minority Children With Asthma

Study Overview
=================
Brief Summary
-----------------
To evaluate the effectiveness of a Head Start-based early intervention for designed to improve asthma management skill and practices of parents, pre-school children and Head Start staff.

Detailed Description
-----------------
BACKGROUND: While increased asthma morbidity and mortality have been observed across all ethnicities, results from several studies have found that asthma morbidity has increased disproportionately in low-income African American children. Elementary school-based asthma education programs have shown promise in improving asthma management, and reducing asthma morbidity in this high-risk population, however, the fastest growing asthma risk is associated with children young than six. By elementary age many parents and children with asthma have well-established patterns of inappropriate asthma management that may be difficult to change. To date, no research has examined the impact of early intervention for asthma management in low-income, high-risk children. DESIGN NARRATIVE: The primary outcome that the study was designed to evaluate medical record documented emergency care for asthma at the JHPED over the eighteen-month follow-up period. The secondary outcomes Adherence with asthma therapy based on Medicaid pharmacy claims for asthma medications, other asthma health care (urgent and primary), self-reported medication adherence, barriers to health care, restricted activity, nighttime symptoms, asthma medications, self and family asthma management behaviors, asthma management self-efficacy, functional status, and quality of life. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Behavioral: Home-based adherence monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Age 2-12 years. A current diagnosis of asthma or reactive airway disease Resident of Baltimore City. Two or more ED visits at the JHPED for asthma in the past 12 months, or hospitalization for asthma at the JHPED in the past 12 months by parent report. Not currently participating in other research studies (participation in previous studies will be noted).

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Home-based adherence monitoring|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Cardiovascular Effects of Adderall in Healthy Adults.

Study Overview
=================
Brief Summary
-----------------
This study is designed to investigate the cardiovascular response (blood pressure, heart rate, electrocardiographic response and blood vessel reactivity response) to taking Adderall in healthy adults.

Official Title
-----------------
Cardiovascular Effects of Adderall in Healthy Adults. A Randomized Clinical Trial.

Conditions
-----------------
Hemodynamics, Cardiovascular System

Intervention / Treatment
-----------------
* Drug: Adderall capsule
* Drug: Placebo capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults 18 years of age and older Healthy subjects without known cardiovascular disease, thyroid disease or documented mental health illness Subjects who are on no medications Subjects with no prior history of regular amphetamine use, and non-prescription stimulants Nonsmokers Exclusion Criteria Subjects with known cardiovascular disease, thyroid disease Subjects with history of psychotic disorders/mental health illness, including but not limited to anxiety, depression, bipolar disorder; history of substance abuse or dependence Subjects currently taking medications Prior history of regular amphetamine use, or non-prescription stimulants Smokers Pregnant subjects Known lactose intolerance (due to presence of lactose in the prepared medication) Family history of sudden cardiac death

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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adderall first, then Placebo<br>Participants will receive an Adderall capsule at the first study visit, then a Placebo capsule at the second study visit. | Drug: Adderall capsule<br>* Amphetamine<br>Drug: Placebo capsule<br>* Placebo capsule<br>|
| Experimental: Placebo first, then Adderall<br>Participants will receive a Placebo capsule at the first study visit, then an Adderall capsule at the second study visit. | Drug: Adderall capsule<br>* Amphetamine<br>Drug: Placebo capsule<br>* Placebo capsule<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood pressure |  | Baseline; 3 hours after intake of active drug/placebo drug | 
| Change in heart rate |  | Baseline; 3 hours after intake of active drug/placebo drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in plasma catecholamines |  | Baseline; 3 hours after intake of active drug/placebo drug |
Mazindol for Cocaine Abuse - 2

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate high and low dose mazindol for cocaine abuse.

Official Title
-----------------
Mazindol for Cocaine Abuse

Conditions
-----------------
Cocaine-Related Disorders

Intervention / Treatment
-----------------
* Drug: Mazindol


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Mazindol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects |  |  | 
| Drug use |  |  | 
| Retention |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cocaine-Related Disorders
Repeatability and Feasibility of Infant Spirometry

Study Overview
=================
Brief Summary
-----------------
This is a study examining repeatability and feasibility of a new method for measurement of lung function in babies. A flexible vest is placed around the torso of the baby, and changes in tidal volume and flow is measured. The study will enable a better understanding of the usefulness of this equipment in a neonatal intensive care unit. The equipment is made by VOLUSENSE Norway AS, and marketed under the name FloRight. The equipment is owned by Volusense Norway AS during the study period.

Official Title
-----------------
Repeatability and Feasibility of Infant Spirometry

Conditions
-----------------
Prematurity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being a Term born and preterm born babies Exclusion Criteria: Being in an unstable clinical condition

Ages Eligible for Study
-----------------
Minimum Age: 4 Weeks
Maximum Age: 3 Months

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 |
| --- | --- |
| Term born babies<br>Term born babies | |
| Preterm babies ready for discharge<br>Preterm babies ready for discharge | |
| Preterm stable babies 1500 grams<br>Preterm stable babies 1500 grams | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repeatability of measurements performed by two different nurses before and after a meal in term babies (10), preterm babies before discharge (10) and preterm babies weighing approximately 1500 grams |  | Before and after a meal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the measurements in the NICU |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Repeatability of measurements
Prediction Model for Lateral Lymph Node Metastasis

Study Overview
=================
Brief Summary
-----------------
Mid to low-lying rectal cancer patient with enlarged lateral lymph node befor treatment and receiving lateral lymph node dissection would be enrolled. Radiomics parameters of lateral lymph nodes would be extracted by expert software. Then a part of the nodes would be used as the training set to build the prediction model, and the another part nodes would be used as the validation set.

Detailed Description
-----------------
After performing lateral lymph node dissection for the enrolled patients, we would find the targeted lateral node which was matched with the enlarged one in imaging from the specimen. Then the nodes would be send for pathological examination. Then we would extract the radiomics parameters of the nodes from the pretreatment CT and MRI with ITK-SNAP software. According to the pathological status, lymph nodes and corresponding radiomics parameters would be divided into positive and negative groups. Then significant parameters would be selected by R software. Then the prediction model with nomogram would be developed. 70% nodes would be used for for model development and the other 30% would be used for validation.

Official Title
-----------------
Radiomics-based Prediction Model for Lateral Lymph Node Metastasis in Rectal Cancer

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Procedure: lateral lymph node dissection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: middle to low-lying rectal adenocarcinoma patients with enlarged lateral lymph node ≥5mm for short diameter in CT and/or MRI Exclusion Criteria: other kind of rectal tumor including neuroendocrine and malignant. high location rectal cancer. recurrent rectal cancer

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Trainning group<br>70% of the whole participants would be randomly divided into the training group to build the predicition model. | Procedure: lateral lymph node dissection<br>* All participted would receive lateral lymph node dissection for rectal cancer.<br>|
| validation group<br>30% of the whole participant would be divided into the validation group to validate the model | Procedure: lateral lymph node dissection<br>* All participted would receive lateral lymph node dissection for rectal cancer.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| metastasis rate of lateral lymph node |  | 2020.1-2022.12.31 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rectal cancer, lymph node metastasis, prediction model
Safety Study of XL844 in Subjects With Chronic Lymphocytic Leukemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and tolerability of different doses of XL844 when given orally to adults with recurrent or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

Official Title
-----------------
A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL844 Administered Orally to Subjects With Chronic Lymphocytic Leukemia

Conditions
-----------------
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

Intervention / Treatment
-----------------
* Drug: XL844


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with recurrent or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) Prior treatment with at least 2 systemic chemotherapy regimens for CLL Life expectancy of >3 months Adequate liver and kidney function Absolute neutrophil count ≥500/mm3; platelets ≥50,000/dL; hemoglobin ≥9 g/dL Willing to use accepted method of contraception during the course of the study Negative pregnancy test (females) Written informed consent Exclusion Criteria: Chemotherapy or radiotherapy within 4-6 weeks of the start of treatment (depending on the therapy) Investigational drug within 30 days of the start of treatment Uncontrolled intercurrent illness such as infection or cardiovascular disease Pregnant or breastfeeding women Subjects known to be HIV positive

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: XL844|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Goal Directed Fluid Management Based on Non-invasive Monitoring

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether goal directed fluid management using respiratory variations in the oxygen saturation by pulse oximetry (SpO2) waveform has potential to decrease postoperative complications and outcomes.

Detailed Description
-----------------
The aim of this study is to test the hypothesis that monitoring and minimizing the respiratory variations in the pulse oximeter waveform amplitude by volume loading has potential to decrease postoperative morbidity and length of stay in the hospital in patients undergoing routine, moderate-risk elective surgery. In this study the investigators will test the impact of hemodynamic optimization based on the respiratory variations in the plethysmographic waveform amplitude to decrease postoperative morbidity and length of stay in the hospital in patients undergoing routine, moderate-risk elective surgery. The primary outcome variable is the incidence of postoperative complications. Secondary outcome variables are the duration of hospital and ICU stays, postoperative mortality, and cost of surgery.

Official Title
-----------------
Goal-Directed Fluid Management Based on Non- Invasive Monitoring of Pulse Oximeter-Derived Pleth Variability Index

Conditions
-----------------
Postoperative Complication

Intervention / Treatment
-----------------
* Procedure: Goal-directed Therapy group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients (male or female) Over 18 years old undergoing non-cardiac surgery Weight > 40 kg, Body Mass Index < 40 Exclusion Criteria: Patients who do not consent Body Mass Index > 40

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Baseline crystalloid infusion of 5 mL/kg/hr of body weight. | |
| Experimental: Goal-directed Therapy group<br>Goal-direct therapy | Procedure: Goal-directed Therapy group<br>* Fluid administration is based on the respiratory variation in the pulse oximeter waveform<br>* Other names: Goal Directed Fluid Optimization group;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of hospital stay | The length of stay in the hospital is defined as postoperative number of days in the hospital until discharge. | Maximum 90 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Goal-directed fluid therapy
Prophylactic Enoxaparin Dosing in Roux-en-Y Gastric Bypass Surgery Patients at St. Vincent Carmel

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess anti-factor Xa concentrations in patients given prophylactic enoxaparin after bariatric surgery.

Detailed Description
-----------------
FDA-approved enoxaparin dosing for venous thromboembolism (VTE) prophylaxis is a fixed-dose regimen irrespective of body mass index (BMI) or actual body weight (ABW). Clinical trials suggest that dosing may be inadequate for obese patients. We plan to assess anti-factor-Xa concentrations in patients who received prophylactic enoxaparin after bariatric surgery. This prospective study will examine 150 anti-factor Xa concentrations from patients 18 years or older undergoing primary Roux-en-Y gastric bypass surgery at St. Vincent Carmel Bariatric Center of Excellence. Patients receive varying prophylactic enoxaparin regimens at the surgeon's discretion. Anti-factor-Xa concentrations are obtained at steady state.

Official Title
-----------------
Prophylactic Enoxaparin Dosing in Roux-en-Y Gastric Bypass Surgery Patients at the St. Vincent Carmel Bariatric Center of Excellence

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years and older undergoing primary roux-en-Y gastric bypass surgery at St. Vincent Carmel Bariatric Center of Excellence Exclusion Criteria: Receiving anticoagulation therapy prior to surgery (i.e. warfarin) Did not receive enoxaparin after surgery

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 |
| --- | --- | --- |
| Anti-factor Xa concentrations from patients 18 years or older undergoing primary Roux-en-Y gastric bypass surgery at St. Vincent Carmel Bariatric Center of Excellence |  | Anti-factor Xa concentrations obtained at steady state (3-5 hours after third enoxaparin dose) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thrombotic events - DVT confirmed by doppler guided ultrasound or PE confirmed by CT scan |  | within 30 days of surgery | 
| Hemorrhagic events - defined as a change in hemoglobin greater than 3 G/dL, transfusion of packed red blood cells, endoscopic procedure indicating GI bleeding, or other major bleeding event documented by physician. |  | within 30 days of surgery | 
| Re-admissions to a hospital within 30 days of surgery due to thrombotic or hemorrhagic event |  | within 30 days of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prophylactic enoxaparin, Roux en Y gastric bypass surgery