cyrilzakka/clinical-trials huggingface dataset:
Psychosocial Determinants of Nutrient Intake in Girls

To better understand the determinants of nutrient intake in black and white adolescent girls and to examine the effects of nutrient intake and eating behaviors on obesity, a significant risk factor for CVD.

BACKGROUND:

Studies have documented the importance of eating behavior as a modifiable risk factor for the development of obesity and cardiovascular disease (CVD). The burden of obesity and CVD is not equally distributed in the population; women from ethnic minority populations are particularly likely to be obese and to have higher rates of CVD and stroke than white women.

DESIGN NARRATIVE:

The study determines the extent to which psychological and familial factors contribute to nutrient intake in black and white girls, beyond the well-established effects of ethnicity and socioeconomic factors. Specifically, the aims of the project are the following: 1) to provide a detailed developmental description of eating behaviors and nutrient intake in black and white girls and to examine the "clustering" of certain eating behaviors (e.g., skipping meals and snacking) into eating patterns; 2) to determine the clinical significance of eating behaviors and eating patterns by examining their contribution to nutrient intake and the development of obesity; 3) to examine the role of psychological and familial factors as determinants of eating behaviors, eating patterns, nutrient intake, and obesity in black and white girls. Capitalizing upon the availability of extensive data collected prospectively among an exceptionally well-maintained cohort of 2,379 black and white females over a 12-year period (from ages 9-10 to ages 21-23), the study applies innovative analytic procedures to further the scientific understanding of the determinants of nutrient intake and eating behaviors in adolescent girls. Participants were assessed annually for ten years as part of the National Heart, Lung and Blood Institute Growth and Health Study (NGHS) with measurements of anthropometry, food intake, eating and weight related attitudes and behaviors and family cohesion. Parents also provided information about weight, eating, and family environment at two assessments. In a subsequent study with the same sample, structured clinical interviews were conducted to determine history of psychiatric disorders and risk factors for eating disorders. Adult weight was also measured.

Eligibility Criteria:
No eligibility criteria
Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II

Single-arm, interventional pivotal clinical trial collecting patient data from use of the AQUABEAM System, a personalized image-guided waterjet resection system that utilizes a high-velocity saline stream to resect and remove prostate tissue in males suffering from Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH) with prostate volumes between 80 mL and 150 mL. The primary endpoints for safety and effectiveness will be measured at 3 months post-treatment. Treated subjects will be followed out to 60 months to collect long-term clinical data.


Eligibility Criteria:
Inclusion Criteria:

* Male age 45-80 years.
* Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction.
* Subject has an IPSS score greater than or equal to 12.
* Maximum urinary flow rate (Qmax) less than 15mL/s.
* Serum creatinine \< 2 mg/dL within 30 days of surgery.
* History of inadequate or failed response, contraindication, or refusal to medical therapy.
* Prostate size ≥ 80 mL and ≤ 150 mL as measured by TRUS.
* Patient is mentally capable and willing to sign a study-specific informed consent form.

Exclusion Criteria:

* BMI ≥ 42.
* Patients unable to stop anticoagulants, antiplatelet agents, or non-steroidal anti-inflammatory agents (NSAIDs, including aspirin greater or equal to 100mg) prior to treatment per standard of care.
* Participants using systemic immune-suppressants including corticosteroids (except inhalants); unable to withhold non-steroidal anti-inflammatory agents (NSAIDs, including aspirin) prior to treatment per standard or care except for low dose aspirin (e.g. less than or equal to 100mg).
* Contraindication to both general and spinal anesthesia.
* Any severe illness that would prevent complete study participation or confound study results.
* History of prostate cancer or current/suspected bladder cancer. Prostate cancer should be ruled out before participation to the satisfaction of the investigator if PSA is above acceptable thresholds.
* History of actively treated bladder cancer within the past two (2) years.
* Clinically significant bladder calculus or bladder diverticulum (e.g., pouch size \>20% of full bladder size).
* Active infection, including urinary tract infection or prostatitis.
* Urinary catheter use daily for 90 or more days consecutively.
* Previous urinary tract surgery such as e.g. urinary diversion, artificial urinary sphincter or penile prosthesis.
* Ever been diagnosed with a clinically significant urethral stricture or meatal stenosis, or bladder neck contracture.
* Known damage to external urinary sphincter.
* Has had an open heart surgery, or cardiac arrest \< 180 days prior to the date of informed consent.
* Participants using anticholinergics specifically for bladder problems. Use of medications with anticholinergic properties is allowable provided the patient does not have documented adverse urinary side effects from these medications.
* Subject is unwilling to accept a transfusion should one be required.
Anti-Leukemia Immune Responses After Irradiation of Extramedullary Tumors

This clinical trial assesses how the immune system responds to leukemia tumors after low dose radiation delivered as part of standard of care. The information learned in this study may help them know if adding immunotherapy (a type of treatment that uses the immune system to fight cancer) can be helpful in future leukemia patients receiving radiation.

PRIMARY OBJECTIVES:

I. To identify changes in anti-leukemia immune responses after local radiotherapy to extramedullary sites.

II. Develop an annotated biospecimen panel of extramedullary leukemia biopsies prior to and after radiotherapy to examine local immune responses using transcriptional profiling, immunofluorescence and single cell analyses.

III. Define changes in the T cell receptor (TCR) clonotypes, functionality and inflammatory cytokine levels in peripheral blood leukocytes and serum.

IV. Correlate changes in anti-tumor immune responses with clinic-pathological variables and patient outcomes.

SECONDARY OBJECTIVES:

I. To assess the overall response rate (ORR= complete response \[CR\] + partial response \[PR\]) of the extramedullary tumor treated with radiation therapy.

II. To assess the CR of extramedullary tumor treated with radiation therapy. III. Determine the duration of response (DOR), event-free survival (EFS).

OUTLINE:

Patients undergo biopsy prior to radiation therapy and 7-14 days after radiation therapy. Patients also undergo blood sample collection prior to therapy (within 7 days of starting radiation therapy), 1 and 7 days post completion of radiation therapy. Patients' photographs of the biopsy site are taken before and at 4-6 weeks post completion of radiation, and their medical records are reviewed for up to 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with new or recurrent myeloid leukemia
* Aged \>= 18 years old
* Eastern Cooperative Oncology Group (ECOG) performance status \< 4
* Patient have measurable and amenable to biopsy under local anesthesia without the need for imaging directed procedure
* Ability to understand and provide signed informed consent
* Females must be surgically or biologically sterile or postmenopausal (amenorrhoeic for at least 12 months) or if of childbearing potential, must have a negative serum or urine pregnancy test within 72 hours before the start of the treatment. Women of childbearing potential must agree to use an adequate method of contraception during the study and until the last radiation treatment. Males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study and until the last radiation treatment

Exclusion Criteria:

* Patients who are unwilling to participate
* Patients unwilling to undergo the biopsy before or after radiotherapy
Observational Real-life Study of Cabozantinib in Monotherapy or in Combination With Nivolumab in Advanced Renal Cell Carcinoma (RCC)

The purpose of this study is to describe the real-life use of Cabometyx® in monotherapy or in combination with nivolumab in Belgium in patients with advanced or metastatic Renal Cell Carcinoma (1st, 2nd and later lines of treatment)


Eligibility Criteria:
Inclusion Criteria:

* Males or females aged 18 years and older
* Patients scheduled to receive Cabometyx® in monotherapy or in combination with nivolumabfor advanced or metastatic renal cell carcinoma
* Decision to treat patients with Cabometyx® in monotherapy or in combination with nivolumab has to be taken prior to and independent from participation in the clinical study
* Provision of written informed consent

Exclusion Criteria:

* Participation in another interventional clinical study at the same time
* Previous participation in this clinical study
Phenotypic Heterogeneity in Hemophilia A: An Investigation of the Role of Platelet Function

The is study will examine whether variation in clinical bleeding frequency and severity among boys with severe Hemophilia A (Factor VIII deficiency) is associated with variations in laboratory measurements of platelet activity.


Eligibility Criteria:
Inclusion Criteria:

* documented circulating FVIII level of ≤1%
* age 3 - 20 years
* may be on primary or secondary prophylaxis
* granting of informed consent

Exclusion Criteria:

* measurable inhibitor level at the time of enrollment
* ingestion of aspirin/supplement known to influence platelet function within 14 days of blood sampling, or ibuprofen within 3 days
An Efficacy, Safety, and Tolerability Study of Canagliflozin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy

The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are receiving treatment with metformin monotherapy (ie, treatment with a single drug) and have inadequate glycemic (blood sugar) control.

This is a randomized (study drug assigned by chance), double-blind (neither the patient nor the study doctor will know the identity of assigned study drug), placebo-controlled, parallel-group,3-arm (3 treatment groups) multicenter study to determine the efficacy, safety, and tolerability of canagliflozin compared to placebo (a capsule that is identical in appearance to canagliflozin but does not contain active drug) in patients with type 2 diabetes mellitus (T2DM) who are not achieving an adequate response from current antihyperglycemic therapy with metformin to control their diabetes. Canagliflozin (a Sodium-Glucose Cotransporter 2 inhibitor) is currently under development to lower blood sugar levels in patients with T2DM. Patients will take single-blind placebo capsules orally (by mouth) for 2 weeks before randomization. Patients will be randomly assigned canagliflozin or matching placebo, orally, twice daily, with 1 capsule taken with the morning meal and 1 capsule taken with the evening meal (2 capsules per day) and concurrent with metformin, if applicable, for up to 18 weeks. The dosing time of metformin should remain the same throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* All patients must have a diagnosis of T2DM and be currently treated with metformin
* Patients in the study must have a HbA1c between \>=7 and \<=10.5%
* Patients must have a fasting plasma glucose (FPG) \<270 mg/dL (15 mmol/L)

Exclusion Criteria:

* History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, diabetes secondary to pancreatitis or pancreatectomy, or a severe hypoglycemic episode within 6 months before screening
Continuous Spinal Anesthesia in Renal Transplantation

Renal transplantation is now recognized as a treatment of choice for patients with end-stage renal disease. An adequate anesthetic technique should achieve hemodynamic stability and enhance perfusion of the transplanted kidney. The aim of this study is to assess the use \& effects of continuous spinal anesthesia for kidney transplantation recipients, compared with balanced general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* ASA class III or IV
* End-stage renal disease
* Renal transplantation candidate patients

Exclusion Criteria:

* Any condition contra-indicating regional anesthesia
* Coagulopathy
* Allergic to any of the drugs used during the procedure
Genetic Characterisation of High-grade Paediatric Osteosarcomas

At present, the only recognised prognostic factor for primary high-grade osteosarcoma is the histological response to preoperative chemotherapy. Our study was designed to identify new diagnostic markers that could eventually have a prognostic value and therapeutic consequences. 80 patients under 20 years of age with primary osteosarcomas were studied while under treatment by the French Society of Paediatric Oncology OS 94 protocol. Paired normal and biopsy samples were collected. In addition, surgical resection specimens, following preoperative chemotherapy, were obtained in many cases. After genomic DNA extraction, an allelotyping analysis targeting microsatellites was planned. The studied DNA regions contained mainly Rb, p53, APC, p16, c-met, TWIST, c-kit, erbB2 and topoisomerases genes. The techniques used in this molecular analysis comprised mainly allelotyping study, quantitative real-time PCR, gene sequencing , immunohistochemistry. The first results showed the prognostic value of 7q31 region containing c-met and 5q21 containing APC (Br J Cancer, 2003, Entz-Werlé et al.), 7p21 containing TWIST (Int J Cancer, 2005, Entz-Werlé et al.) and 4q21 targeting c-kit gene (J Clin Oncol, 2005, Entz-Werlé et al.).


Eligibility Criteria:
Inclusion Criteria:

* Patients under 20 years of age with primary osteosarcomas
* Under treatment by the French Society of Paediatric Oncology OS 94 protocol
Safety and Efficacy of Sitaxsentan in the Treatment of Pulmonary Arterial Hypertension

This is a clinical research study designed to evaluate an investigational new medication called sitaxsentan for the treatment of pulmonary arterial hypertension (patients with NYHA functional class II, III or IV). The purpose of this study is to evaluate the safety and effectiveness of two different doses of sitaxsentan, compared to placebo (inactive treatment) for the treatment of pulmonary arterial hypertension. Patients who complete this trial may be eligible to take part in an extension trial (Protocol FPH01-X). Eligible patients who receive placebo in the 12-week study cross over to receive sitaxsentan for the extension trial.


Eligibility Criteria:
Inclusion Criteria:

1. NYHA Class II, III or IV
2. 16 to 75 years of age
3. Specific peak VO2 range
4. PPH, PAH due to connective tissue disease or select congenital heart disease
5. Qualifying cardiac catheterization
6. History of CXR and qualifying pulmonary function test
7. History of qualifying ventilation-perfusion lung scan
8. History of qualifying echocardiogram
9. Women of childbearing potential must use contraceptives
10. Stable dose of corticosteroids if prescribed

Exclusion Criteria:

1. Significant lung disease
2. Chronic liver disease
3. Uncontrolled sleep apnea
4. History of specific types of left heart disease
5. Any disorder that compromises ability to give informed consent
6. Uncontrolled sleep apnea
7. Inability to perform bicycle exercise test
8. On-going treatment with an experimental drug or device within the last 30 days
9. HIV infection
10. Specific liver dysfunction
11. Chronic renal disease
12. Pregnancy/Nursing
13. Chronic active hepatitis B or C
14. Chronic Flolan or Tracleer use within the last 30 days
STUDIO DELLE MANIFESTAZIONI CARDIOVASCOLARI A LUNGO TERMINE MEDIANTE TECNICHE DI IMAGING

The aim of the project is to identify the prevalence and characteristics of long-term cardiovascular changes in Covid-19 infection.

In the follow-up of patients with Covid-19 infection, persistence of cardiovascular symptoms is common. Studies of the acute phase of Covid-19 infection have shown a significant prevalence of acute myocardial damage (15-44%), and imaging studies have confirmed the presence of structural changes in the pericardium and myocardium several months after the acute phase.

The aim of the project is to identify the prevalence and characteristics of long-term cardiovascular changes in Covid-19 infection.

The study is a continuation of the project "Registry "CARDICoVRISK"" which collected data on cardiovascular changes during the acute phase and shortly after the acute phase. The study design is retrospective observational. The study plans to enroll 240 patients hospitalized during the acute phase of COVID-19 infection. Patients will be collected at three separate centers. Enrolled patients will undergo a baseline evaluation by history, physical examination, laboratory tests, ECG, 6-minute walking test and echocardiogram.

If alterations in left ventricular or right ventricular systolic function are found, as per the standard clinical approach, a cardiac MRI examination will be evaluated.

Identification of patients with cardiac changes is of paramount importance as they may benefit from early initiation of cardioprotective therapy and may need different follow-up strategies.

Eligibility Criteria:
Inclusion Criteria:

* Patient with previous hospitalization for Covid-19 infection confirmed by pharyngeal molecular swab
* Adult patients between 18 and 90 years of age
* Signature of informed consent

Exclusion Criteria:

* Patient with poor echocardiographic acoustic window impairing the performance of the examination
* Patients with atrial fibrillation
* Patients with ischemic or nonischemic heart disease with known decreased left ventricular systolic function
Safety and Immunogenicity of GPO Seasonal Trivalent Inactivated Influenza Vaccine in Healthy Thai Adults

The study is aim to evaluate the safety and immunogenicity of one dose (15 μg HA per strain per dose) of the GPO seasonal trivalent inactivated split virion influenza vaccine (Tri Fluvac) in healthy adults aged 18 to 49 years over 90 days post-injection.

This is a double blind randomized study consisting of two phases - Phase I and Phase II. The same vaccine, a seasonal trivalent inactivated split virion influenza vaccine \[A/California/7/2009, reassortant virus NYMC X-181 (H1N1), A/Victoria/210/2009, reassortant virus NYMC X-187 (H3N2), and B/Brisbane/60/2008, reassortant virus NYMC BX-35 virus strains\] will be given in both Phase I and Phase II of the study.

The vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm. After vaccination volunteers will remain at the clinic for at least 30 minutes to observe for any reactogenicity after immunization. Total follow-up is 90 days.

Blood specimens will be collected on Day 0 prior to vaccination, Day 21, Day 60, and day 90.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Age 18-49 years old
* Having Thai ID card or equivalent
* All hematology, biochemistry and urine analysis are within normal range or of no clinical significance (not higher than 1.5 time of normal value without any clinical finding from history and physical examination)
* Able to read and write and sign written informed consent form or assent form.

Exclusion Criteria:

* Known history of egg allergy
* Having had recently influenza infection confirmed as H1N1, H3N2, or Flu B within 3 months preceding enrolment to the trial
* Vaccination against influenza in the past 6 months preceding enrolment to the trial
* History of bronchial asthma, chronic lung diseases, chronic rhinitis
* History of immunodeficiency state
* History of immunosuppression \< 6 months prior to immunization
* History of anaphylactic or other allergic reactions to influenza vaccine or any vaccine component or excipient (e.g. gentamicin or thimerosal)
* Acute infectious with fever \> 38 degree Celsius and noninfectious diseases (within 72 hours) preceding enrollment in the trial
* The volunteers who have been taking immunoglobulin products or have had a blood transfusion during past 3 months before the beginning of the experiment
* Participation in other research study
* Pregnancy or plan to become pregnant for 60 days after enrollment or breast feeding
* Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
* Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled, or could interfere with the evaluation of the vaccine
Treatment Choice and Outcomes for ESRD: Evidence From the First Year of a Nationwide Randomized Evaluation

The investigators plan to analyze the first year of a nationwide randomized-controlled trial of end stage renal disease (ESRD) treatment choice model (ETC). This mandatory-participation program was designed by the Centers for Medicare and Medicaid Services and randomization was conducted at the hospital referral region (HRR) level. 95 HRRs were assigned to the treatment group beginning in January 2021. The investigators will study the impact of this program in the first year on treatment modality choice for ESRD and explore heterogeneity in impact across patients and providers.


Eligibility Criteria:
Inclusion Criteria:

* All Medicare-certified ESRD facilities and Medicare-enrolled managing clinicians located in HRRs in the United States are required to participate.
* Patient is receiving dialysis or other services for ESRD
* Patient is new to dialysis, defined as not having received dialysis for at least 12 months prior to their first observed dialysis claim
* Patient is enrolled in Medicare Part B

Exclusion Criteria:

* HRRs in US territories
* HRRs with 20% or more zip codes in Maryland (excluded from randomization)
* Facilities and clinicians with fewer than 11 attributed beneficiaries
* Patient is receiving dialysis only for an acute kidney injury
* Patient is younger than 66 years of age before initiating dialysis
* Patient received a kidney transplant within 12 months prior to the start of dialysis and does not have a kidney transplant failure code
* Patient is enrolled in Medicare Advantage, a cost plan, or other Medicare managed care plan
* Patient resides outside of the US or in one of the US territories
* Patient has elected hospice
* Patient has a diagnosis of dementia at any point in the first 90 days or the preceding 12 months before initiating dialysis as identified using Centers for Medicare and Medicaid Services Hierarchical condition categories (CMS-HCC)
* Patient is residing in or receiving dialysis in a skilled nursing facility (SNF)