cyrilzakka/clinical-trials huggingface dataset:
Study of Immune Responses in Patients With Metastatic Melanoma

In this study, anti-OX40 will be given to patients with melanoma to find out how the immune system responds to treatment with anti-OX40. It is hoped that this treatment will cause an immune response against melanoma resulting in tumor regression, but this is not known at this time. Anti-OX40 is a large protein that can help immune cells that fight bacteria, viruses and cancer cells.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with measurable or evaluable unresectable, stage IV metastatic melanoma. Either histologic or cytologic diagnosis is acceptable.
2. Eastern Cooperative Oncology Group (ECOG) performance status 0, or 1 (Appendix A.)
3. Age 18 years or above.
4. Laboratory values (performed within 28 days prior to enrollment) as follows:

   * WBC ≥2000/microliter
   * Absolute lymphocyte count \>300/mm3
   * Serum creatinine \<1.5 X upper limit of laboratory normal
   * Hgb \>8g/dl (patients may be transfused to reach this level)
   * Hct \> 24%
   * Platelets \>100,000 cells/mm3
   * Total bilirubin \<1.5 X upper limit of laboratory normal, unless due to Gilbert's disease
   * AST (SGOT)/ALT (SGPT) \<2.5 X upper limit of laboratory normal
   * Alkaline phosphatase \<2.5 X upper limit of laboratory normal
   * HIV Negative
   * Hepatitis B surface antigen Negative
   * Hepatitis C antibody Negative
5. Women of childbearing potential must have a negative pregnancy test and must avoid becoming pregnant while on treatment. Men must avoid fathering a child while on treatment. This exclusion is required due to the unknown toxicities that anti-OX40 may have on the forming fetus, spermatogenesis or the nursing child. Also, because pregnancy may impair immune function it may limit the treatment efficacy.
6. Ability to give informed consent and comply with the protocol. Patients with a history of psychiatric illness must be judged able to understand fully the investigational nature of the study and the risks associated with the therapy.
7. No active bleeding.
8. No clinical coagulopathy (INR \<1.5, PT \<16 seconds, PTT \< 38 seconds).
9. Anticipated lifespan greater than 12 weeks.
10. Failed at least one prior medical therapy for metastatic melanoma.

Exclusion Criteria:

1. Active infection.
2. History of or active autoimmune disease.
3. Prior mouse monoclonal antibody treatment.
4. Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus.
5. Need for chronic maintenance oral steroids.
6. Active brain metastatic disease. Treated brain metastases with surgery, gamma-knife radiosurgery and/or whole brain radiation and stable for at least 4 weeks and off steroids are eligible.
7. Any medical or psychiatric condition that in the opinion of the PI would preclude compliance with study procedures.
A Phase II Clinical Trial of Suppression of Human Antimouse Antibody and Human Antitoxin Response to Immunotoxin LMB-1 by Rituximab

This is a phase II clinical and pharmacokinetic study of suppression of human antimouse (HAMA) and antitoxin antibodies (HATA) to immunotoxin LMB-1 by Rituximab (anti-CD20). The primary objective of this study is to determine the effect of Rituximab on HAMA and HATA response to LMB-1 administered to patients with advanced carcinoma that express the B3 antigen. Other objectives include evaluation of the pharmacokinetics and anti-tumor effects.

This is a phase II clinical and pharmacokinetic study of suppression of human antimouse (HAMA) and antitoxin antibodies (HATA) to immunotoxin LMB-1 by Rituximab (anti-CD20). The primary objective of this study is to determine the effect of Rituximab on HAMA and HATA response to LMB-1 administered to patients with advanced carcinoma that express the B3 antigen. Other objectives include evaluation of the pharmacokinetics and anti-tumor effects.

Eligibility Criteria:
Patients must have advanced stage solid tumor with histologically or cytologically proven evaluable or measurable disease and who are refractory to standard treatment for their malignancy or for whom no effective standard therapy exists.

Must have the presence of B3 antigen on the surface of greater than 30% of the tumor cells.

Must be greater than or equal to 18 years old and be able to give informed consent.

Must have an ECOG performance status of 0 or 1 and a minimum life expectancy of 3 months.

Must have normal renal function (Creatinine less than or equal to 1.4 mg/dl), SGOT and SGPT less than or equal to 2.5 x of the upper limits of normal. Total bilirubin less than 1.5 mg/dL; AGC greater than or equal to 1.5 x 10(3) microliter; platelets greater than 100,000 per mm(3).

Must have recovered from the toxic effects of prior chemotherapy or radiation therapy. At least 3 weeks must have elapsed since the last dose of chemotherapy, hormonal therapy or radiation therapy. At least six weeks must have elapsed since the last dose of Mitomycin C and a nitrosourea.

Must not have serum neutralizing antibodies to LMB-1.

Must not have positive hepatitis B surface antigen, hepatitis C antibody or HIV.

Must not have a history of coronary artery disease, NY class II-IV CHF, arrhythmia requiring treatment and any contraindication to pressor therapy.

Must not have FEV1 and FVC less than or equal to 65% of the predicted value.

Must not have baseline serum albumin of less than 3.0 g/dl.

Must not have a history of CNS metastasis and/or known seizure disorders, or concurrent malignancy.

Must not have an acute bacterial infection that requires antibiotic therapy (unless infection is completely resolved).

Must not have any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.

Must not be pregnant or breastfeeding. Patients of childbearing potential must agree to use an effective method of contraception.

Must not have a history of allergic reaction to penicillin.

Must not have lymphoma.
Infant Chest Compression

Pediatric cardiac arrest is an uncommon but critical life-threatening event requiring effective cardiopulmonary resuscitation (CPR). About 16,000 pediatric cardiac arrests occurs in the United States annually. Only 8% of the patients survive to hospital discharge and of these, up to two-thirds have neurological sequelae. Majority of pediatric cardiac arrest are below age of two and have poorer chance of survival versus older children


Eligibility Criteria:
Inclusion Criteria:

* active paramedics
* voluntary consent

Exclusion Criteria:

* pregnancy
* back pain
* wrist pain
BRCA1/2 Flu Vaccine

To evaluate immune function in BRCA1/2 mutation carriers without cancer, specifically to determine whether immune function in healthy individuals with germline loss of function BRCA1/2 mutations, impacts overall immune health and fitness.


Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Over age 25
* BRCA1 or BRCA2 pathogenic or likely pathogenic mutation
* No personal cancer history apart from non melanoma skin cancer, localized thyroid cancer, in situ cancers of any type
* Participants must sign the informed consent form

Exclusion Criteria:

* Are allergic to influenza vaccination
* Have received influenza vaccination within the past 6 months
* Require prednisone, methotrexate, or other immunosuppressing medications
* Have HIV infection
* Have a history of solid organ tumor or bone marrow transplant
* Require combination immunotherapy;
* Are on other studies requiring blood draws that might exceed 450 mL total during the period of the influenza vaccine study
Effect of Thyroid Hormone on Post-Myocardial Infarction Remodeling and Prognosis in STEMI Patients

This study aims to determine whether thyroid hormone levels are predictive of cardiac remodeling following myocardial infarction and the prognosis in patients with STEMI receiving primary percutaneous coronary intervention.


Eligibility Criteria:
Inclusion Criteria:

* with a confirmed STEMI diagnosis
* undergoing primary percutaneous coronary intervention (presenting \<12h after symptom onset)
* patients agreed and provided informed consent

Exclusion Criteria:

* past history of myocardial infarction or percutaneous coronary intervention or coronary artery bypass graft
* past history of heart failure (LVEF\<40%) or myocardiopathy or atrial fibrillation
* past history of thyroid diseases, or were treated with amiodarone, dopamine, or corticosteroids before hospital admission
* contraindicating to cardiac magnetic resonance imaging
Integrating a Mental Health Intervention Into Primary Health Care for Refugees

The objective of this study is to evaluate the impact of an evidence-based mental health intervention (Common Elements Treatment Approach) on medication adherence, behavioral improvement and clinical outcomesamong adults taking medication for hypertension, diabetes and epilepsy using a two-arm randomized wait-list controlled trial among adult refugees in Mae La camp, Thailand.


Eligibility Criteria:
Inclusion Criteria:

* A. Inclusion criteria:

  1. Patients who was diagnosed by physician based on ICD 10 to have diabetes, hypertension or diabetes with hypertension comorbidity, or epilepsy.
  2. Registered in chronic database system of the camp.

B. Exclusion criteria:

1. who are younger than 18 years old
2. who have severe physical illness
3. who have severe mental disorders
4. who will not stay in the camp until the end of the program
5. who are not willing to participate in the program

Exclusion Criteria:

-
Genetics of Arteriovenous Malformations

The goal of this study is to identify genetic alterations resulting in the development of arteriovenous malformation (AVM) in the central nervous system.

The study will include AVM patients and members of their nuclear family. All patients will donate a sample of saliva (5 mL) or blood (10 mL). Basic demographic and clinical parameters will be collected, including ethnicity, age at first presentation, symptoms at presentation, history of subsequent symptoms, treatment history, Spetzler-Martin AVM grade, medication history, and other pertinent medical information. In patients undergoing AVM resection, a small sample of the AVM will be collected for concurrent genomic analysis. Family members will donate saliva (5mL) and document their relationship to the patient (i.e., parent, sibling, child, etcl). Nucleic acids will be isolated from the saliva/blood samples, and genetic sequencing will be carried out. When a surgical sample of the AVM is available, nucleic acids will be obtained and transcriptome profiling will be performed. Identification of genetic alterations common to patients with AVM and not present in samples from parents and siblings will greatly aid in identification of pathways associated with AVM formation. Candidate sequences will be chosen by differential expression (p\<0.05) and fold-changes. Once identified, mechanisms for the rapid detection of marker sequences will be developed and their predictive value tested in future collections.

Eligibility Criteria:
Inclusion Criteria:

* Age between 6 and 60 years inclusive
* Diagnosis of AVM or nuclear family member of a patient with AVM
* Grants access to saliva, blood, and/or tissue

Exclusion Criteria:

* Age less than 6 years or greater than 61 years
* Nuclear family members who do not share the same parents as the AVM patient
Clinical Trial to Investigate the Pharmacokinetic/Pharmacodynamic Drug-Drug Interaction of Pyrimethamine and Metformin IR

This study aims to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of pyrimethamine and metformin IR after oral administration in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* healthy male subject aged 20 to 45 at screening A body weight in the range of 50 kg (inclusive)
* 100 kg (inclusive) with ideal body weight range of +- 25% subjects who decide to participate voluntarily and write a informed consent form

Exclusion Criteria:

* subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor
* Subject judged not eligible for study participation by investigator.
The Use Of Liposomal Bupivacaine For Pain Control

The purpose of this research study is to determine how well the local anesthetic, liposomal bupivacaine, controls postoperative pain after mastectomy and breast reconstruction.

Eligible subjects will be identified prior to surgery. On the day of surgery, each patient will be randomized to be in either Local infiltration of bupivacaine OR liposomal bupivacaine. Study will be double blinded to patients and Investigators. Patients assigned to the local infiltration with bupivacaine group will receive a total 60 ml of 0.25% bupivacaine with 30 ml delivered to each breast. Patients assigned to the local infiltration of liposomal bupivacaine will receive a total of 20 ml liposomal bupivacaine (266 mg) with 10 ml of 0.25% bupivacaine and 30 ml of 0.9% sodium chloride. These injections will occur at the end of the mastectomy and prior to the insertion of the tissue expander implant. After this intraoperative injection, patients will not receive any more doses of local anesthetics.

Eligibility Criteria:
Inclusion Criteria:

* All patients who receive a bilateral mastectomy with immediate sub-pectoral implant based breast reconstruction
* Age ≥ 18 years
* Ability to understand and the willingness to sign an (Institutional Review Board) IRB-approved informed consent document.
* Patients who receive tissue expander placement or direct permanent implant placement will be included in the study.

Exclusion Criteria:

* Patients who receive an autologous tissue reconstruction.
* Patients who receive a unilateral reconstruction.
* Patients who are expected to undergo axillary lymph node dissection
* Patients who have undergone breast irradiation
* Patients who abuse narcotics or have chronic pain (using greater than 40 mg equivalents of oxycodone per day)
* Patients who are wards of the state
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to bupivacaine or liposomal bupivacaine.
* Pregnant women are excluded from this study because pregnancy precluded immediate breast reconstruction in our patient population.
* Patients who weigh less than 50 kg, as there can be dose related toxicities of the bupivacaine dosing used n this study.
* Patients with moderate-severe hepatic or renal impairment because of the increased risk of toxicity.
* Patients receiving bilateral mastectomy with immediate pre-pectoral implant based reconstruction
Effect of Platelet Storage on Complement Activation

Platelet units are stored and complement factors are evaluated

Ten units of platelets will be selected from the regular inventory of the Central Blood Transfusion Services/Assiut University Hospitals . All units of platelets will be collected, processed, and tested following the standard procedures.

Thesis units will be stored on a platelet rotator with the temperature controlled between 22 and 24c. Samples will be obtained using a sterile technique .

The investigators will take basal sample and samples on day 2,3,4 and 5. Complement components will be assayed : C4 (classical pathway), C3 (common pathway) and C5 (terminal pathway).

This evaluation will be done using ELISA technique

Eligibility Criteria:
Inclusion Criteria:

* Negative screening and confirmatory tests will be done for all platelet donors

Exclusion Criteria:

* Use of aspirin or non steroidal anti-inflammatory drugs or medication affecting the platelets.
Targeted Left Ventricular Lead Placement, Comparison of Active Fixation Bipolar and Passive Quadripolar Pacemaker Leads

A prospective, randomized and patient-blinded trial comparing an active fixation left ventricular lead with quadripolar passive left ventricular leads. The leads were compared in order to identify differences in the electrical performance, the ability to achieve a stable proximal position in a coronary vein located concordant to target segment and clinical outcome. The patients were followed up for 12 months.

A prospective, randomized and patient-blinded trial. The objective was to compare an active fixation left ventricular lead with quadripolar passive left ventricular leads. The left ventricular segment with latest mechanical activation was identified as target segment by radial strain speckle-tracking echocardiography.The leads were compared in order to identify differences in the electrical performance, the ability to achieve a stable proximal position in a coronary vein located concordant to target segment and clinical outcome. The clinical outcomes were assessed by echocardiography, change in New York Heart Association (NYHA) functional class and Minnesota Living With Heart Failure Questionnaire (MLHFQ). The patients were followed up for 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Left Ventricular Ejection Fraction (LVEF) ≤ 35 %
* NYHA 2-4
* Electrocardiogram : left bundle branch block (LBBB) and QRS duration \>120 ms or non-LBBB and QRS duration ≥150 ms
* Optimal medical treatment.

Exclusion Criteria:

* Upgrade procedures due to ventricular pacing
* No written consensus
Cognitive Behavioral Therapy for Adolescent Binge Eating and Loss of Control Eating

This study will develop and test a cognitive-behavioral intervention for adolescents with binge/loss-of-control eating.

Youth who engage in binge eating or loss-of-control eating are at high risk for physical and mental health impairment, as well as excess weight gain. As there are few evidence-based treatments for adolescents with binge/loss-of-control eating, assessment and treatment have received minimal attention for adolescent patients. Among adults, cognitive-behavioral therapy (CBT) has a strong evidence base for binge-eating disorder. Adolescents have unique social, cognitive and emotional needs because of their developmental stage; unique treatment approaches are essential to meet these unique needs. This study will develop a new CBT treatment for adolescents with binge eating or loss-of-control eating (modifying adult CBT for binge-eating disorder, conducting interviews with adolescents about aspects of treatment that need to be modified, conducting an open series of patients who receive the active treatment). This study will also test the efficacy of the newly-developed CBT for adolescents with binge/loss-of-control eating versus a control group in a randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria: To be included, adolescents must:

1. Be in the age range ≥12 years old and ≤17 years old;
2. Have a BMI that places them above the 85th percentile based on their age and sex;
3. Report 2 episodes of binge/LOC eating (feeling a loss of control while eating) per month for the past 3 months;
4. Be otherwise-healthy youth (i.e., no uncontrolled or serious medical conditions);
5. Read, comprehend, and write English at a sufficient level to complete study-related materials;
6. Be available for participation in the study for 7 months.

Exclusion Criteria: Prospective participants will be excluded if the adolescent:

1. Has a medical or psychiatric condition that would require hospitalization or intensive care (e.g., neurological disorder, psychotic disorders, suicidality);
2. Has a medical or psychiatric condition that would prohibit them from engaging in behavioral treatment or moderate physical activity (e.g., cardiovascular problems);
3. Has uncontrolled medical condition(s) (e.g., uncontrolled diabetes or hypertension);
4. Is pregnant or breastfeeding;
5. Is taking medication(s) or participating in treatment(s) that could influence weight or appetite;
6. Began taking hormonal contraceptives less than 3 months prior;
7. Has a developmental or cognitive disorder (e.g., autism spectrum disorder);
8. Has a concurrent feeding/eating disorder (e.g., bulimia nervosa); or
9. Is participating in another clinical research study.
Swimming Training Repercussion on Metabolic and Structural Bone Development; Benefits of the Incorporation of Whole Body Vibration or Plyometric Training: The RENACIMIENTO Project

Swimming training is associated with decreased bone mass and lower bone mass acquisition during growth periods, mainly when compared to other weight-bearing sports. Little information is available in adolescents pointing in the same direction but still controversial.

On the other hand, bone strength do not only depends on bone mass but on bone structure and microarchitecture. The cross sectional area, cortex thickness or trabecular density are important aspects of bone health. There are few studies on the effect of swimming on bone architecture of adolescents. This information is relevant for present and future health of adolescents practicing swimming and for all the organizations promoting this sport. Jumping and whole body vibration training programs seem to elicit important osteogenic effects; however, there is little information on this regard in adolescent population, even less in these adolescents with potentially decreased bone acquisition such as swimmers.

The main aims of this research project are therefore, to analyze the effect of swimming training on bone mass, metabolism, structure and architecture in adolescents analyzing possible relationships among them. Secondly, to test whether including short boots of jumping or whole body vibration may be able to palliate the possible deleterious effects of swimming and facilitate a normal or even healthier bone development. And finally to study the durability of training-related bone gains over time.


Eligibility Criteria:
Inclusion Criteria:

* Specific for the swimmers: With a history of training at least 3 years for more than 6 hours per week and currently still training
* Specific for the control group: Subjects that do not perform more than 3 hours of physical activity per week

Exclusion Criteria:

* Non-caucasian
* Smoking
* Taking medication affecting bone
Metformin for Weight Loss in Schizophrenia

Study hypothesis is that patients on antipsychotics medication treated with metformin will show loss in weight and improved measures of glucose metabolism.

Patients who had gained more than 10 lbs of weight in the last 3 months or had BMI of 35 or greater were treated with metformin up to 2500 mg/day in an open label study of up to 3 months time. Changes in weight and glucose measures were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be 18-70 years of age;
* Currently hospitalized or an outpatient at MPC;
* BMI ≥ 35 or excessive recent weight gain ( \> than 10 lb weight gain in the past 3 months);
* Patients will have a diagnosis of schizophrenia or schizoaffective disorder or bipolar disorder.

Exclusion Criteria:

* Age below 18 or over 70;
* Patient is currently already treated with metformin.