cyrilzakka/clinical-trials huggingface dataset:
Long-Term Outcomes of Alternative Brachytherapy Techniques for Early Prostate Cancer

The purpose of this research study is to assess outcomes of treatment for early prostate cancer. Current treatments for early (non-metastatic) cancer may cause long-term impairments in the patients quality of life. In this study we will compare the outcomes of patients treated with two alternative brachytherapy (seed implants) techniques using a series of questionnaires.

Participants will be asked to complete a questionnaire about their health prior to treatment, at 1, 3 and 12 months after treatment and then once a year 4 more times.

Eligibility Criteria:
Inclusion Criteria:

* Pathological diagnosis of an adenocarcinoma of the prostate
* 18 years of age or older
* Prior choice of either standard brachytherapy or MRIGPB as primary treatment

Exclusion Criteria:

* Prior primary therapy (surgery or external beam radiation) for prostate cancer
* Current hormone ablation therapy
The EC50 of Remifentanil Blunting Hemodynamic Response to Double Lumen Tube Intubation

The purpose of this study is to evaluate the effect site concentration of remifentanil blunting hemodynamic changes to tracheal intubation of single or double lumen tubes.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing thoracic surgery that require one lung ventilation

Exclusion Criteria:

* patient who does not agree with this study
* BMI \< 16.0 or BMI \> 30
* cardiovascular disease, pulmonary disease, renal disease
* alcoholic abuser or drug abuser
* patient who takes any drug to influence cardiovascular system or sympathetic nervous system
* any use of local anesthetics or drugs to influence cardiovascular system during tracheal intubation
A Patient and Provider Intervention to Address Health Disparities in Lung Cancer Screening

To test the impact of a multilevel intervention on primary (provider-patient communication, intentions, and knowledge) and secondary (screening referrals and completion) outcomes.

The proposed study will target two key levels of influence in the healthcare setting: provider and patient behavior in order to address disparities between African American and whites in lung screening awareness and utilization. Guided by NIH's Health Disparities Research Framework and building on the formative work conducted in the K99 phase, we will conduct a quasi-experimental study (pretest-posttest, with a nonequivalent control group) in partnership with four primary care clinics within the MedStar Health system in the R00 phase.

Eligibility Criteria:
Inclusion Criteria:

* 50-80 years old;
* current cigarette smoker or quit within 15 years;
* a 20+ pack-year smoking history;
* non-adherent to lung screening (\>13 months);
* English-speaking;
* scheduled for an upcoming clinic appointment (4 weeks - 8 weeks); and
* able and willing to provide meaningful consent and complete telephone interviews

Exclusion Criteria:

* Individuals with a history of lung cancer
Microvascular Response in Diabetes Mellitus

Vascular and neurological mechanisms are both likely to be involved in foot ulcer. We recently reported on the hand an original transient pressure-induced vasodilation (PIV) during a 5 mmHg/min increase of pressure strain using laser Doppler flowmetry. This physiological response to non noxious external local pressure strain is a widely protective cutaneous mechanism. The impairment of PIV in diabetic subjects may be relevant to the high prevalence of foot ulcer that occurs in these individuals. The aim of the project is to analyse the different physiopathological processes involved in PIV impairment in diabetic subjects as compared to matched controls.

The whole study is a prospective observational study of diabetic type 1 and type 2 subjects focusing on the various physical, physiopathological or pharmacological mechanisms that may interfere with the normal response of the cutaneous microcirculation.The study is currently conducted under various parallel groups of patients and control subjects matched on age and sexe. Techniques used for the study are only non-invasive investigations such as iontophoresis with laser doppler flowmetry, clinical and paraclinical non-invasive investigation of peripheral neuropathy, ultrasound imaging of peripheral arteries.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes

Exclusion Criteria:

* Non diabetic neuropathy
* Peripheral arterial disease
* pregnancy
Single-cell CBD Biomarkers of Inflammation Reduction in People Living With HIV

People living with HIV (PLWH) are affected by comorbidities appearing to be strongly related to chronic inflammation, a condition characterizing PLWH.

The investigators propose to study the effects of CBD on inflammation in PLWH, and establish the molecular role of different immune cells in this process. The investigators plan to use single cell RNA-sequencing (scRNAseq) to isolate CBD-specific cellular phenotypes from five persons with HIV who will provide blood samples before and after taking CBD.


Eligibility Criteria:
Inclusion Criteria:

* Willingness to take CBD and to participate in follow up for two months
* Older than 21 and younger than 60
* Under antiretroviral therapy for 5+ years and suppressed viral load (CD4 count \<350cells/ml)

Exclusion Criteria:

* Conditions/medications that may impair the immune response, e.g., rheumatoid arthritis, cancer, diabetes, chronic infections, CAD (Cold agglutinin disease), cellulitis, autoimmune diseases such as lupus, sarcoidosis
* All medications that may affect inflammation such as aspirin, steroids, statins; CD4 count \<350cells/ml), pregnancy, and current marijuana or CBD use (urine drug screen)
* UF(University of Florida)/Shands staff and students will not be considered for enrollment
Gestational Diabetes: a Cohort Study

Gestational diabetes (GDM) is the most common hormonal complication during pregnancy. Its occurrence implies an increased risk of maternal and fetal complications and, therefore, its diagnosis and treatment are extremely important. Since the adoption of the new diagnostic criteria proposed by the International Association of Diabetes and Pregnancy Study Groups (IADPSG) in 2010, an increasing number of cases of mild hyperglycemia have demanded follow-up and treatment. The need and benefit of treatment in these cases of mild hyperglycemia has been discussed worldwide. Women who have been diagnosed with GDM are at increased risk for type 2 DM in the years following gestation. Other factors (such as lipid profile, obesity, adipokine dosage) may also be related to the repercussions of GDM on the maternal-fetal binomial, since gestations with satisfactory glycemic control can also present complications related to the disease and increased risk of type 2 DM in the long term. The present study aims to investigate factors associated with the need for insulin use, the occurrence of perinatal complications, nutritional status, physical activity and weight retention one year after delivery and the postpartum diagnosis of type 2 DM 10 years after delivery in women diagnosed with GDM according to the current criteria suggested by the IADPSG.


Eligibility Criteria:
Inclusion Criteria:

* single pregnancies
* absence of glucose intolerance prior to gestation (defined by prior diagnosis of polycystic ovarian syndrome or fasting glycemia ≥100mg / dl or 2hr post-overload with 75g glucose ≥ 140mg / dL or glycated hemoglobin ≥ 5.7% previously to pregnancy)
* absence of chronic use of glucocorticoids or antiretroviral drugs for HIV virus, given its diabetogenic effect and potential confounding
* diagnosis of GDM according to diagnostic criteria proposed by the IADPSG, namely: initial fasting blood glucose ≥ 92mg / dL OR oral glucose tolerance test of 75g with fasting ≥ 92mg / dL or after1h ≥ 180mg / dL or after 2h ≥ 153mg / dL
* Agreement with the informed consent term for patients who will be followed prospectively
* Agreement with the free and informed consent term for recall and reassessment of the patients identified in the retrospective analysis of the data

Exclusion Criteria:

* loss to follow up during pregnancy
A Study of Serum Protein Profiling in Patients With Non-Small Cell Lung Cancer Treated With Gefitinib or Erlotinib

We hypothesize that Epidermal growth factor receptor tyrosine kinase inhibitors modulate tumor changes that may be reflected in the alteration of serum proteins.

Study objectives are:

* To establish serum proteomic changes in patients with non-small cell lung cancer (NSCLC) receiving erlotinib or gefitinib.
* To identify a serum protein profile that predicts erlotinib or gefitinib sensitivity or resistance in NSCLC patients with and without EGFR mutations.
* To study the toxicity of erlotinib or gefitinib by correlating clinical toxicity with serum protein profile.

Background:

Although some success has been achieved in identifying Epidermal growth factor receptor (EGFR) mutations as a molecular predictive marker of response in patients with non-small cell lung cancer (NSCLC), this strategy is likely only to be limited as not all responding patients have a mutation in their tumor and conversely, not all patients with a mutation were responders. Furthermore, as the development of resistance to EGFR tyrosine kinase inhibitors (TKI) such as gefitinib, erlotinib is inevitable and poses a major clinical problem due to limited therapeutic options, the identification of a molecular profile that could predict sensitivity to erlotinib or gefitinib is warranted.

Hypothesis:

Using serum as an easily accessible biological fluid, we hypothesize that EGFR TKIs modulate tumor changes that may be reflected in the alteration of serum proteins.

Objectives:

* To establish the serum proteomic changes in NSCLC patients receiving erlotinib or gefitinib.
* To identify a serum protein profile that predicts erlotinib or gefitinib sensitivity or resistance in NSCLC patients with and without EGFR mutations.
* To study the toxicity of erlotinib or gefitinib by correlating clinical toxicity with serum protein profile.

Significance:

An extensive profiling of the molecular circuitry affected by EGFR TKIs would be helpful in understanding the response and side effects of patients with NSCLC treated with erlotinib or gefitinib and could guide therapy and thus improve patient outcome.

Eligibility Criteria:
Inclusion Criteria:

* Any patient with NSCLC receiving erlotinib or gefitinib.
* Patients with unexpected and/or severe treatment related toxicity whilst receiving EGFR TKI.
* Age ≥ 18 years
* Written informed consent.
Reliability and Validity of Thai Calgary Depression Scale of Schizophrenia (CDSS)

Depression in patients with schizophrenia is common. Several factors was found to be associated with depression including medical illness, quality of life, positive symptoms, and typical antipsychotics. The Calgary depression scale of schizophrenia (CDSS) is commonly used for screening depression in schizophrenia,however; the Thai version of CDSS has not been validated.

This study aims to a.) test the reliability and validity of the Thai version of Calgary depression scale of schizophrenia (CDSS) and b.) identify the prevalence and factors associated with depression in patients with schizophrenia including quality of life, type of antipsychotic drugs, and severity of schizophrenia in 60 patients with schizophrenia at the Faculty of Medicine, Chiang Mai University, Thailand.

Measurements:

The Thai version of Calgary depression scale of schizophrenia (CDSS), Positive and Negative Syndrome Scale (PANSS), Hamilton Rating Scale for Depression-17 (HAM-D 17), Montgomery-Asberg Depression Rating Scale (MADRS), the Thai abbreviated version of World Health Organization quality of life (WHOQOL-BREF-THAI).

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or over
* Diagnosis of schizophrenia according to DSM-IV-TR

Exclusion Criteria:

* Having organic brain syndrome
* Not fluent in Thai
Effectiveness of a Cloud-based Digital Health Navigation Program for Colorectal Cancer Screening

mPATH-CRC (mobile Patient Technology for Health) is an automated direct-to-patient digital health program about colorectal cancer screening. The goal of this project is to test a cloud-based version of mPATH that patients can use at home independent of a scheduled medical visit. Patients will access mPATH on their own devices using a hyperlink sent via text message. The cloud version of mPATH will have the proven effective content of the tablet version, including the ability to request a screening test directly via the program. mPATH will then share this information with the patient's healthcare organization so screening can be arranged. This cloud-based version will be highly scalable, have broad reach, and be easy to support, making it a commercially viable product. This project will (1) test the reach and effectiveness of the mPATH web app in two different healthcare settings: a Fee-for-Service setting, and a value-based care setting; and (2) determine the value generated by mPATH in each healthcare setting.


Eligibility Criteria:
Inclusion Criteria:

1. Age 45 - 74 years old
2. Have no record of current colorectal cancer screening per United States Preventive Service Task Force guidelines. Current screening is defined as:

   1. Completed a colonoscopy within the last 10 years
   2. Completed a FIT-DNA (example: Cologuard) test within the past 3 years
   3. Completed a FIT in the last 1 year
3. Have a cell phone number listed in the EHR
4. Have a preferred language of English or Spanish in the EHR
5. Have a upcoming primary care appointment within 9 to 16 days

Exclusion Criteria:

1. Prior diagnosis of colorectal cancer.
2. Prior diagnosis of inflammatory bowel disease
3. Diagnosis of condition that would make patient inappropriate for CRC screening

   1. Moderate to severe liver disease (ICD-10)
   2. Metastatic solid tumor (ICD-10)
   3. AIDS (ICD-10)
Evaluate the Efficacy and Safety of Combination Treatment With DW1501-R1+DW1501-R2 Versus DW1501-R1 or DW1501-R2+DW1501-R3 in Patients With Hypertension and Dyslipidemia

A Multicenter, Randomized, Double-blinded, Double-dummy, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Combination Treatment with DW1501-R1+DW1501-R2 Versus DW1501-R1 or DW1501-R2+DW1501-R3 in Patients with Hypertension and Dyslipidemia


Eligibility Criteria:
Inclusion Criteria:

* Adults both male and female who are ≥19,\<80 years old
* at screening, 140mmHg≤ SBP\<180mmHg \& 90mmHg≤ DBP\<110mmHg \& LDL-C≤250mg/dL \& triglyceride\<400mg/dL

Exclusion Criteria:

* at screening, the difference BP of one-side arm is SBP ≥ 20mmHg and DBP ≥ 10mmHg
* secondary hypertension or secondary dyslipidemia
* patients who have uncontrolled diabetes melitus, hyper/hypothyroidism or cardiac disease
* women who are pregnant or lactating
Phase II/III Study of the Tolerance and Efficacy of Combined Use of Didanosine (2',3'-Dideoxyinosine; ddI) and Lentinan in HIV-Positive Patients

To determine the tolerance and side effects of a combination of lentinan and didanosine (ddI) in comparison with ddI alone. To determine whether the combination of lentinan and ddI produces a significant immunorestorative effect within the study observation period (6-12 months) as measured by an increase in one or more of the following: neutrophil count and activity, T-cell subsets, and a decrease in p24 antigen.

Patients are treated with daily oral ddI for 6 weeks, then are randomized to ddI in combination with intravenous lentinan or placebo (administered once weekly) for 26 weeks. Patients who are already stabilized on 400 mg/day ddI will proceed directly to randomization. Following completion of the combination therapy, patients may be offered 26 additional weeks of therapy on an optional basis.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV seropositivity.
* Absolute CD4 count of 200 - 500 cells/mm3.
* No active opportunistic infection or Kaposi's sarcoma.

Prior Medication:

Allowed:

* Prior ddI for no longer than 3 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Lymphoid malignancy.
* Pancreatitis.
* Peripheral neuropathy.
* Critical illness.

Concurrent Medication:

Excluded:

* Antiretroviral agents other than ddI.
* Steroids.
* Cytotoxic agents.
* Immunosuppressive agents.
* Immunomodulators.
* 1-Thyroxine.

Concurrent Treatment:

Excluded:

* Radiotherapy.

Prior Medication:

Excluded within 1 month prior to study entry:

* Antiretroviral agents other than ddI (patients may have received prior ddI for no longer than 3 months total).
* Steroids.
* Cytotoxic agents.
* Immunosuppressive agents.
* Immunomodulators.

Prior Treatment:

Excluded:

* Radiotherapy within 1 month prior to study entry. Active IV drug abuse.
Erector Spinae Block and Transverse Abdominis Plane Block for Sleeve Gasterectomy

assess the efficacy of ultrasound guided erector spinae block to decrease the requirement for analgesics after laparoscopic sleeve gastrectomy and to decrease postoperative pain scores and opioid consumption compared to subcostal transverses abdominis block.

Primary outcomes

• Cumulative opioid consumption during the first 24 h postoperatively. For the purpose of comparison, all opioids administered postoperatively will be converted to IV morphine equivalent doses using standard opioid dosage conversion tables.

Secondary outcome parameters

1. Pain assessment by the aid of Visual analogue scale (VAS), which is consisted of a "10 cm" line with one end labeled no pain and other end labeled worst intolerable pain. The patients marked the line at the point that best describing the pain intensity. The preoperative assessment included training of the patients about (VAS) for postoperative pain. The length of the line to the patient's mark will be measured and recorded postoperative after 30 min., 4, 6, 8, and 24 hours.
2. Failure rate of the block will be calculated, where the block will be considered a failed block if the patient requires more than two doses of rescue analgesia in the first hour postoperatively.
3. Duration of surgery (from skin incision till skin closure) and general anesthesia (from induction of GA till extubation).
4. Incidence of complications, such as: Nerve injury, Hematoma formation, LA toxicity, and intravascular injection.

Eligibility Criteria:
Inclusion Criteria:

* • Patients from 18 to 59 years.

  * BMI \> 40 kg/m2
  * Genders eligible for study: both.
  * ASA I-III.
  * No contraindications for application of regional anesthesia as Patient refusal, local anesthetic allergy, local sepsis or infection at puncture site, INR \> 1.5 or \< 12 hours post LMWH.

Exclusion Criteria:

* • Patient refusal.

  * Extremes of age.
  * ASA IV.
  * Increased intracranial pressure.
  * Coagulopathy or thrombocytopenia less than 100000/ml.
  * Sepsis (increased risk of meningitis).
  * Infection at the puncture site.
  * Pre-existing neurologic disease.
  * History of allergy to local anesthetic.
Barrett's Esophagitis in Anorexia Nervosa Binge/Purge Subtype

To better define the presence of Barrett's esophagus (BE) via non-endoscopic testing in an eating disorder cohort with purging (vomiting/rumination) behaviors

A prospective cohort study to assess the presence of BE in those with purging behaviors from their eating disorders has not been completed. There are multiple case reports describing a younger population not meeting typical screening guidelines whom developed this condition. To better define the presence of Barrett's esophagus (BE) via non-endoscopic testing in an eating disorder cohort with purging (vomiting/rumination) behaviors. Individuals with severe forms of eating disorders with purging and ruminating behaviors not meeting the current screening guidelines for BE will still test positive for BE.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with an eating disorder diagnosis that includes purging history
* Ages 18-65
* Purging history =\>5 years
* Purging or rumination at a minimum of once daily upon admission.
* Admission to the ACUTE Center for Eating Disorders and Severe Malnutrition

Exclusion Criteria:

* Any eating disorder diagnosis that does not include purging behaviors
* Ages under 18 and over 65
* Patients who otherwise meet the current ACG screening guidelines (chronic GERD and 3 or more risk factors for Barrett's mentioned in the Background)
* Received mandated care at time of enrollment
* Inability to consent to participate in the research
Pulse Steroids Versus Oral Steroids in Problematic Hemangiomas of Infancy

The purpose of the study is to determine if pulse steroids are more efficacious and safer than the standard treatment with oral corticosteroids.

Currently there is no prospective study in hemangioma patients answering critical questions such as: which type of steroid should be used,how much should we use and for how long. This study is an investigator blinded study with two arms:one arm is receiving standard treatment with daily oral corticosteroids and the other is receiving intravenous pulse corticosteroids daily for 3 days, monthly for 3 months. The main outcome of the study is assess the efficacy of each treament modality as the percentage improvement in the hemangioma's appearance. The secondary outcomes are the safety profiles of the two drugs and the changes in the angiogenesis markers as a result of treatment intervention.

Eligibility Criteria:
Inclusion Criteria:

* problematic facial hemangiomas (periorbital/facial hemangiomas with potential visual obstruction, large/dysfiguring hemangiomas)
* 1-4 months of age
* signed consent form

Exclusion Criteria:

* refusal to participate
* age \> 4 months
* complicated nonvisible hemangiomas
* congenital heart disease
Safety Study of Measles-Mumps-Rubella-Varicella (MMRV) Vaccine, Priorix-Tetra™ in Children Living in the Philippines

This study will collect data on the safety of the MMRV vaccine (Priorix-Tetra™) used in routine practice in children aged 12 months to 12 years living in the Philippines.

The participating physicians will enroll only those subjects for whom they would prescribe Priorix-Tetra in the course of their normal clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol.
* Written informed consent obtained from the parent(s)/LAR(s) of the subject.
* Male or female subjects living in the Philippines between, and including, the ages of 12 months and 12 years at the time of the vaccination.
* Female subjects of child bearing potential may be enrolled in the study, if the subject:

  * has agreed to be abstinent or practiced adequate contraception for 30 days prior to vaccination, and
  * has a negative pregnancy test on the day of vaccination, and
  * has agreed to continue adequate contraception during the entire treatment period and for 3 months after completion of the vaccination.

Exclusion Criteria:

* Child in care.
* Any contraindications to vaccination as stated in the Prescribing Information.
* Acute, severe febrile illness at the time of enrollment. The presence of a minor infection, such as a cold, will not exclude the subject from the study.
* Previous receipt of a measles, mumps, rubella and/or varicella-virus containing vaccine less than 3 months prior to study entry.
* Previous enrolment in this trial.
* Subjects with impaired immune function, including primary or secondary immunodeficiencies based on medical history.
* History of hypersensitivity to any component of the vaccine.
* History of hypersensitivity following previous administration of measles, mumps, rubella and/or varicella-virus containing vaccines.
* Receipt of human gamma globulins or a blood transfusion within 3 months prior to study entry.
* Hypersensitivity to latex.
* Pregnant or lactating female.