linjc16/ctgov huggingface dataset:
Efficacy and Safety of Oral Encochleated Amphotericin B for the Treatment of Cryptococcal Infection

Study Overview
=================
Brief Summary
-----------------
This will be an open label phase I/II prospective cohort study to determine the efficacy and safety of CAMB for the treatment and prevention of cryptococcal infection.

Official Title
-----------------
A Prospective Cohort to Evaluate the Efficacy and Safety of Oral Encochleated Amphotericin B (CAMB/MAT2203) for the Treatment of Cryptococcal Infection

Conditions
-----------------
Cryptococcal Infections

Intervention / Treatment
-----------------
* Drug: Encochleated Amphotericin B


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV infection, informed consent, cryptococcal infection present, diagnosed by either: CSF cryptococcal culture, CSF cryptococcal antigen (CRAG), plasma/serum CRAG Exclusion Criteria: Presence of jaundice or known liver cirrhosis, >72 hours antifungal therapy, pregnancy or breastfeeding, unlikely to attend regular clinic visits

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: Sequential Assignment
Interventional Model Description: Patients with symptomatic cryptococcal meningitis will be enrolled in treatment arm Patients that are CRAG positive will be enrolled the in prevention arm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Symptomatic Cryptococcal Meningitis<br>CAMB (Encochleated Amphotericin B) | Drug: Encochleated Amphotericin B<br>* lipid-crystal nanoparticle formulation of amphotericin B; oral<br>* Other names: MAT2203;|
| Experimental: Asymptomatic Cryptococcal Antigenemia<br>CAMB (Encochleated Amphotericin B) | Drug: Encochleated Amphotericin B<br>* lipid-crystal nanoparticle formulation of amphotericin B; oral<br>* Other names: MAT2203;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of drug over 14 days of dosing | Tolerability of drug as measured by the proportion of doses received versus the number of scheduled doses | 14-days | 
| Microbiologic clearance of Cryptococcus from the CSF |  | 14-days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | stratified by symptomatic and asymptomatic subgroups | 14-days | 
| Survival from cryptococcal infection | stratified by symptomatic and asymptomatic subgroups | 10-weeks | 
| Pharmacokinetics | PK parameter of Area Under the Curve (AUC) | 24-hours | 
| Pharmacokinetics | PK parameter of the maximum concentration (Cmax) | 24-hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
amphotericin B, cryptococcal
Efficacy and Safety of Treatment With a Single Dose of 90Y-ibritumomab Tiuxetan in Patients With Low Tumor Burden Untreated or Indolent NHL

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see how well Zevalin works in the treatment of low grade indolent B-cell lymphoma when given to patients who have not had any previous treatment for their lymphoma and who otherwise would be followed on a watch & wait policy.

Official Title
-----------------
Efficacy and Safety of Treatment With a Single Dose of 90Y-ibritumomab Tiuxetan in Patients With Previously Untreated Low Tumor Burden Indolent Non-Hodgkin's Lymphoma

Conditions
-----------------
Lymphoma

Intervention / Treatment
-----------------
* Drug: 90Y-ibritumomab tiuxetan (Zevalin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically confirmed indolent lymphoma including: follicular grade 1 or 2 small lymphocytic marginal zone (nodal) marginal zone (splenic) mucosa associated lymphoid tissue (MALT) no evidence of transformation Stage III or IV disease No prior therapy involvement by less than 25% of bone marrow on assessment of trephine biopsy absolute lymphocyte count ≤ x 109/L platelets ≥ 150 x 109/L hemoglobin ≥ 100g/L absolute neutrophil count ≥ 1.5 x 109/L at least one bidimensionally measurable lesion at least 2cm by CT scanning Exclusion Criteria: any other anticancer treatment for NHL prior radiation therapy prior myeloablative therapy (bone marrow or peripheral blood stem cell transplant) no other malignancy within the past 10 years except adequately treated non-melanoma skin tumors or carcinoma in situ of the cervix presence of central nervous system lymphoma patients known to be HIV positive patients with known seropositivity for Hepatitis C virus, Hepatitis B virus or other active infection uncontrolled by treatment patients with abnormal liver function: total bilirubin > 1.5X ULN or ALT > 2.5X ULN patients with abnormal renal function: serum creatinine > 2.5X ULN known hypersensitivity to murine antibodies or proteins immunotherapy during the preceding 6 months (including monoclonal antibodies, interleukins, interferon)

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: 90Y-ibritumomab tiuxetan (Zevalin)|nan|

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

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  |  |
Monitoring Vital Signs With a Wireless Ingestible Device in Subjects Undergoing Polysomnography

Study Overview
=================
Brief Summary
-----------------
This Minimal Risk study is designed to evaluate the ability of the Celero ingestible Vitals Monitoring Pill (i.e., VM Pill) to measure respiration from within the gastrointestinal tract, in addition to performing an exploratory comparative analysis of data collected by the VM Pill and data collected from clinical monitoring sensors as part of polysomnography.

Official Title
-----------------
Monitoring Vital Signs With a Wireless Ingestible Device in Subjects Undergoing Polysomnography

Conditions
-----------------
Sleep

Intervention / Treatment
-----------------
* Device: Vitals Monitoring Pill System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy individuals ages 18 - 65 inclusive who are indicated for a polysomnography study. Exclusion Criteria: Patients with a history of abdominal surgery and/or any condition that may impact the GI tract, including but not limited to: Constipation Esophageal stricture Esophagitis Gastritis Gastric ulcers Peptic ulcer Gallstones Celiac Disease Crohn's Disease Ulcerative Colitis Irritable Bowel Syndrome Diverticulitis Colorectal cancer

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients undergoing polysomnography<br> | Device: Vitals Monitoring Pill System<br>* The Celero Vitals Monitoring Pill (VM Pill) uses 3 axis accelerometry to measure physiological signals from within the GI tract.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the ability of the VM Pill to monitor respiration from within the GI tract | Mean absolute error between respiratory rate measured by the VM Pill and respiratory rate measured by PSG monitoring equipment during periods of normal breathing while the patient is sleeping or at rest. | During polysomnography |
Efficacy of Methylsulfonylmethane Supplementation on Osteoarthritis of The Knee: A Randomized Controlled Study

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to determine the efficacy of methylsulfonylmethane (MSM) in treating patients with knee OA.

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Dietary Supplement: Methylsulfonylmethane (MSM)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: symptomatic knee OA for at least 6 months according to the clinical criteria of the American College of Rheumatology (ACR) radiographic confirmed knee OA according to the Kellgren & Lawrence scale Exclusion Criteria: acute septic arthritis inflammatory arthritis any other type of arthritis history of knee buckling or recent knee injury lack of physical or mental bility to perform or comply with the treatment procedure diabetes mellitus fibromyalgia or other chronic pain syndromes concurrent anti-coagulant/anti-platelet drugs arthroscopy or intra-articular injections in the previous 3 months

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Purified MSM<br> | Dietary Supplement: Methylsulfonylmethane (MSM)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC questionnaire |  |  |
Urine Metabolomics and Colorectal Cancer Screening

Study Overview
=================
Brief Summary
-----------------
This is a prospective, multi-centered study to assess whether urine metabolomics can play a role in the screening of colorectal cancer (CRC). Urine samples will be collected from 1000 patients going through an established CRC screening program, and from a further 500 patients who already have a diagnosis of CRC. Using nuclear magnetic resonance (NMR) spectroscopy, the 1H NMR spectrum of urine samples will be analyzed for specific metabolites, and establish the metabolomic signature of colorectal cancer. The results from metabolomic urinalysis of this screening cohort will be compared with results from colonoscopy, histological descriptions, fecal occult blood testing (FOBT), and fecal immune testing (FIT) to assess the accuracy of urine metabolomics in identifying patients with polyps and malignancies. The urine metabolomic results from the colorectal cancer group will be correlated with operative, histological and clinical staging to define the role of urine metabolomics in assessing colorectal cancer type, location and stage. Additionally approximately 300 urine samples from breast cancer patients and 300 from prostate cancer patients will be collected to validate that the colorectal cancer signature is unique.

Official Title
-----------------
Is There a Role for Using NMR Urine Metabolomics as a New Method of Screening for Colorectal Cancer?

Conditions
-----------------
Colorectal Cancer, Colorectal Polyps

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For Screening group (normal colonoscopy & colonic polyps): asymptomatic, 50-75 year old, without personal or family history of CRC/polyps asymptomatic, 40-75 year old, known personal or first-degree family history of either CRC or polyps For Cancer group: any patient with diagnosis of colorectal cancer any patient with diagnosis of prostate cancer any patient with diagnosis of breast cancer Exclusion Criteria: For screening group: hematochezia inflammatory bowel disease on anticoagulation for reasons other than atrial fibrillation significant co-morbidities For Cancer group: already had neoadjuvant treatment at time of urine collection no invasive cancer at time of urine collection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Normal colonoscopy<br> | |
| Colonic polyps<br> | |
| Colorectal cancer patients<br> | |
| Breast & Prostate Cancer patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Transarterial Chemoembolization (TACE) Therapy of Hepatocellular Carcinoma (HCC) With Blocking Tumor Blood Temporarily and Enhancing Perfusion

Study Overview
=================
Brief Summary
-----------------
According to radiology imaging, the patients of HCC are divided into two groups(hypovascular tumor group and moderately vascular tumor group). Every group is divided into TACE therapy with balloon catheter subgroup and regular TACE therapy subgroup. Patients take the TACE therapy each 45 days, and have MRI diffusion examine or CT one week before next therapy. All objects are observed until the end event happening or in the group for 6 months.

Official Title
-----------------
Phase 1,Single-blind, Randomized, Controlled Study to Evaluate the Safety and Effectivity of TACE Therapy of HCC(Hepatocellular Carcinoma) With Blocking Tumor Blood Temporarily and Enhancing Perfu

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Procedure: balloon catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: sign the written informed consent form provided. diagnosed clinically as HCC,need to take TACE. Exclusion Criteria: have had an allergic reaction following iodine. have been in any TACE or radiotherapy or biotherapy within 30 days before the study. HCC of diffuse type,failure of hepatic function, chronic illness or disease including failure of heart function, uncontrolled high blood pressure, heart disorders, serious infection, uncontrolled diabetes mellitus.

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: balloon catheter|transcatheter arterial chemoembolization therapy with balloon catheter|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 2010 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hepatocellular carcinoma, transcatheter arterial chemoembolization, overall survival
Video HIT in Sudden Sensorineural Hearing Loss

Study Overview
=================
Brief Summary
-----------------
The function of the vestibular system among patients with Sudden Sensori Neural Hearing Loss will be evaluted using the video Head Impulse Test

Official Title
-----------------
Video HIT Results in Sudden Sensorineural Hearing Loss Patients

Conditions
-----------------
Sudden Sensorineural Hearing Loss

Intervention / Treatment
-----------------
* Diagnostic Test: Video Head Impulse Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients hospitalized with the diagnosis of Sudden Sensorineural Hearing Loss Exclusion Criteria: Vertigo Other etiology causing dizziness Neurological dysfunction othe than the hearing loss Difficulty performing the vHIT Chronic vestibular disorder Pregnant women

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Sudden Sensorineural Hearing Loss<br> | Diagnostic Test: Video Head Impulse Test<br>* Diagnosis of dysfunction of the semicircular canals using the vHIT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The gain of each canal, as calculated using the vHIT | Gain measured by the vHIT system | 15 minutes |
Total Lifestyle Coaching Pilot Study (TLC)

Study Overview
=================
Brief Summary
-----------------
The investigators aim to develop, pilot and evaluate a new Total Lifestyle Coaching (TLC) program, that will address both information and behavior-change aspects of nutrition education for patients whose body mass index (BMI) exceeds 25.

Detailed Description
-----------------
This is a single-arm pilot study of patients at the Revere Healthcare Center with a BMI greater than 25. The intervention consists of a single in-person assessment with a dietician followed by telephone coaching sessions addressing nutrition, sleep, stress-reduction skills, and physical activity over the course of 6 months. Study team assessed anthropomorphic, demographic, and behavioral measures prior to the initial dietician assessment and at study completion (6 months following enrollment). Semi-structured exit interviews assessing participants' experiences in the program were also conducted following program completion.

Official Title
-----------------
Total Lifestyle Coaching Pilot Study (TLC)

Conditions
-----------------
Obesity, Weight Loss, Telemedicine

Intervention / Treatment
-----------------
* Behavioral: Total Lifestyle Coaching (TLC)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 21 and older body mass index (BMI) exceeds 25 speaks English has access to a telephone able to come into MGH-Revere health center for at least four face-to-face meetings over a six month period. overweight (BMI exceeds 25)

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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: TLC Program<br>The TLC Program consists of one in-person visit with a licensed dietician and biweekly phone coaching sessions. During the program, the dietician will 1) identify specific nutrition goals, 2) review and tailor the education materials to the patient's needs, and 3) set up regular telephone coaching sessions of up to two sessions per month for six months for each patient. Motivational interviewing and nutrition/health coaching will be provided. | Behavioral: Total Lifestyle Coaching (TLC)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Weight | Change in weight between baseline (week 0) and post intervention (week 26) | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Stress Scale | Change in perceived stress as measured by the PSS-10 questionnaire administered at baseline (week 0) and post intervention (week 26). Score range is 0 - 40 with higher scores indicating higher perceived stress. | 26 weeks |
Trial of Oxytocin Alone Versus Oxytocin and Propranolol for the Treatment of Abnormal Labor

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether propranolol is better than oxytocin for the treatment of labor abnormalities. The endpoint is the rate of vaginal delivery experienced by women receiving prolonged oxytocin versus propranolol.

Detailed Description
-----------------
This trial was designed to test if propranolo can reduce the c section rate for dysfuctional labor. Due to stringent inclution and exclusion criteria and low enrollment the study was closed.

Official Title
-----------------
Placebo-Controlled Randomized Trial of Oxytocin Alone Versus Oxytocin and Propranolol for the Treatment of Dysfunctional Labor

Conditions
-----------------
Dysfunctional Labor

Intervention / Treatment
-----------------
* Drug: Propranolol
* Other: IV Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be term pregnancy (> 37 weeks) Vertex presentation Active labor (4-5 centimeters dilated) Exclusion Criteria: Heart disease Diabetes Currently taking propranolol Contraindications to labor or vaginal delivery Multiple gestations Preterm Chorioamnionitis

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IV Propranolol<br>IV dose propranolol | Drug: Propranolol<br>* IV Propranolol 1mg/min for a total of 2 minutes. Total dose 2mg<br>* Other names: Inderal;|
| Placebo Comparator: IV Placebo<br>IV Placebo of saline solution equal to propranolol in volume | Other: IV Placebo<br>* IV Saline Solution<br>* Other names: Normal Saline;|

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
-----------------
Labor, Dysfunctional Labor, Labor Arrest, Primary Cesarean Section Prevention