cyrilzakka/clinical-trials huggingface dataset:
A Study of LY3023414 and Necitumumab in Squamous Lung Cancer

The main purpose of this study is to evaluate the safety and activity of the study drug known as LY3023414 in combination with necitumumab in participants with metastatic squamous non-small cell lung cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed squamous advanced NSCLC (Stage IV).
* Participants must have progressed on one prior line of platinum-based chemotherapy in the advanced or metastatic setting.
* Measurable disease as measured by response evaluation criteria in solid tumors (RECIST) criteria v 1.1.
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
* Able to swallow the study drugs whole.
* Adequate organ function.
* Women of childbearing potential must have a negative serum or urine pregnancy test performed ≤ 7 days prior to start of treatment. Women of childbearing potential or men with partners of childbearing potential must use effective birth control measures during treatment and during the 3 months following completion of study treatment.

Exclusion Criteria:

* Participants who have received \> 1 prior line of chemotherapy in the advanced or metastatic setting. (Immunotherapy will not be considered a line of chemotherapy.)
* Prior treatment with a PI3K/mTOR inhibitor, epidermal growth factor receptor (EGFR) inhibitor, and/or necitumumab.
* History of brain metastases unless irradiated ≥ 2 weeks prior to first study treatment and stable without requirement of corticosteroids.
* Have serious pre-existing medical conditions.
* Have insulin-dependent diabetes mellitus. Participants with a type 2 diabetes mellitus are eligible if adequate control of blood glucose level is obtained by oral anti-diabetics.
* Women who are pregnant or breast-feeding.
* Clinically significant electrolyte imbalance ≥ Grade 2.
* Currently receiving treatment with therapeutic doses of warfarin sodium. Low molecular weight heparin and oral Xa inhibitors are allowed.
* Have initiated treatment with bisphosphonates or approved receptor activator of nuclear factor kappa-B ligand (RANK-L) targeted agents (e.g. denosumab) ≤ 28 days prior to Day 1 of Cycle 1.
* Concurrent serious infection requiring parenteral antibiotic therapy.
* Have a second primary malignancy that in the judgment of the investigator and Medical Monitor may affect the interpretation of results.
* Have an active, known fungal, bacterial, and/or known viral infection.
* History of arterial or venous embolism within 3 months prior to study enrollment. If the embolism occurred \>3 and \<6 months, the participant is eligible provided appropriate treatment according to institutional standard of care is ensured.
A Care Management Intervention for Non-cardiac Chest Pain

The investigators developed and implemented an eight-week multicomponent care management intervention for non-cardiac chest pain. Team members including a cardiologist, nurse, and psychiatrist. Impressions and recommendations were shared with the patient's primary care physician. Measures of chest pain severity, frequency and impact and measures of psychological health and health-related quality of life were completed at baseline and intervention completion.

The investigators developed and implemented an eight-week multicomponent care management intervention for non-cardiac chest pain. The care management team consisted of a nurse, cardiologist, and psychiatrist. Following a one-time consultation visit with the cardiologist and nurse, evaluation and treatment recommendations were conveyed to the participant's primary care physician. Then, the nurse completed eight weekly phone calls with the participant to provide support, introduce therapeutic principles, and assist with coordination of care, under the supervision of a psychiatrist. Intervention feasibility was assessed on several domains including adherence, recruitment, attrition, safety, and data collection. To examine preliminary efficacy, participants completed Likert scales of chest pain symptom severity, frequency and impact, and measures of psychological health (Patient Health Questionnaire-9, General Anxiety Disorder-7, Patient Health Questionnaire-15) and health-related quality of life (12-Item Short Form Survey) at baseline and intervention completion.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of non-cardiac chest pain, defined as chest pain recurring at least once per week for two weeks with at least two of the following objective tests: (1) electrocardiogram without ischemic changes; (2) negative cardiac enzymes; (3) non-ischemic cardiac stress test.
* Primary care physician affiliated with the institution

Exclusion Criteria:

* History or subsequent diagnosis of cardiac disease
* Objectively diagnosed alternative medical etiology of chest pain (e.g., gastroesophageal disease)
* Resolution of chest pain prior to enrollment
* Cognitive impairment, assessed using a six-item screen
* Inability to communicate in English
* Lack of telephone access (precluding weekly phone call participation).
Study to Evaluate Effects of INL1 in Patients With Heart Failure and Reduced Ejection Fraction

This is a multicenter, randomized, double-blind, placebo-controlled, dose-response trial in patients with chronic stable Heart Failure (HF) and reduced Left Ventricular Ejection Fraction (LVEF) to evaluate the efficacy and safety of three INL1 doses compared with placebo. Patients will be treated for approximately 12 weeks with one of three INL1 doses: 50 mg, 150 mg, 300 mg, or, placebo capsules, taken twice daily (BID).


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of HF requiring chronic treatment of loop diuretics
* Left Ventricular Ejection Fraction (LVEF) ≤ 40% at screening by echocardiography
* N-Terminal-prohormone of Brain Natriuretic Peptide (NT-proBNP) ≥400 pg/mL at screening for patients without atrial fibrillation or atrial flutter, or, NT-proBNP ≥ 1,200 pg/mL at screening for patients with atrial fibrillation or atrial flutter
* Treated for Heart Failure with stable, optimal pharmacological therapy
* Acceptable screening echocardiographic image quality

Exclusion Criteria:

* Female patients of childbearing potential
* Patients with a New York Heart Association (NYHA) Class I or IV
* Heart failure that is clearly caused by toxin / drug such as Adriamycin
* Significant medical conditions or recent history suggesting the patient's study participation will potentially pose a major risk to patient's safety and well-being
* Need for routine scheduled outpatient IV infusions for Heart Failure or scheduled ultrafiltration
* History of rhabdomyolysis or history of autoimmune diseases
* Severe renal disease
* Hepatic disease
* Pulmonary disease limiting exercise capacity
* Atrial fibrillation with rapid ventricular response
* Life expectancy of less than 6 months
* Type 1 diabetes mellitus or Type 2 diabetes mellitus with very poor glycemic control
* Patients with anemia
Mesenteric Bacterial Translocation in Evolved Crohn's Disease

Mesenteric fat can be invaded by gut bacteria through a process called bacterial translocation, which is the invasion of viable bacteria from the gastrointestinal tract to extraintestinal sites (mesenteric lymph nodes, liver, spleen, kidney, bloodstream, etc.). In Crohn's disease (CD), bacterial translocation could increase the disproportionate inflammatory response already present and contribute to disease progression by stimulating the production of pro-inflammatory cytokines and immune-cell infiltration in the mesentery. Several mechanisms may promote bacterial translocation, such as bacterial overgrowth, disruption of the intestinal mucosal barrier and alterations in the immune system.

Ileocecal surgical resection is required in some patients with complicated or refractory CD. Unfortunately, post-surgical disease recurrence happens in up to 40% of cases, probably defining a subgroup of CD patients with a particular aggressive form of the disease. The complete microbiome (in gastrointestinal and extraintestinal sites) in CD patients that develop early post-surgical recurrence, as well as the association to innate immunity alterations, has not yet been studied.

The primary aim of the study is to explore the bacterial microbiome of CD patients and its association with early post-surgical recurrence and clinical or genetic variables related to innate immunity. To achieve this, the bacterial DNA present in mesenteric fat and ileal tissue (inflamed and non-inflamed) from surgical resection samples as well as blood samples from CD patients will be studied. Genetic polymorphisms, relevant clinical data and disease recurrence will also be evaluated.

The investigators hypothesize that bacterial translocation to the mesentery fat near the inflamed intestine is one of the mechanisms for perpetuation and chronicity of inflammation and therefore post-surgical recurrence in CD. The investigators expect to find a distinctive bacterial profile (in quantity and quality) in the mesenteric fat of patients with early post-surgical recurrence and/or with genetic variants that cause alterations in innate immunity.

The study of the microbiome in CD could help to identify the patients with a more aggressive disease form that will probably present early post-surgical recurrence, and could raise the possibility of microbial modulation as therapy for CD.


Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years or older)
* Informed consent signed
* To require an ileocecal resection as part of the treatment of Crohn's Disease
* In the case of controls: not having Inflammatory Bowel Disease and requiring an ileocecal resection for another reason

Exclusion Criteria:

* To require an ileocecal resection with definitive or transient ileostomy
* In the case of controls: existence of a family history of Inflammatory Bowel Disease.
MK-0954E Study in Participants With Hypertension (MK-0954E-357)

This study is being done to evaluate the efficacy, safety, and tolerability of losartan potassium 50 mg (L50) + hydrochlorothiazide 12.5 mg (H12.5) + amlodipine besylate 5 mg (A5) (MK-0954E). The primary hypothesis is that L50/H12.5/A5 is more effective in lowering mean trough sitting diastolic blood pressure (SiDBP) after 8 weeks of treatment compared to L50+A5 in Japanese participants with essential hypertension who are not adequately controlled following an 8-week treatment with filter period study drug (L50+A5).


Eligibility Criteria:
Inclusion criteria

* Participant has a diagnosis of essential hypertension.
* Participant is being treated with single or dual treatment for hypertension and will be able to discontinue the prior antihypertensive medication.
* Participant has a mean trough SiDBP of ≥ 90 mmHg and \< 110 mmHg.
* Participant has a mean trough SiSBP of ≥ 140 mmHg and \< 200 mmHg.
* Participant has no clinically significant abnormality at screening visit.

Exclusion criteria

* Participant is currently taking \> 2 antihypertensive medications.
* Participant has a history of significant multiple and/or severe allergies to ingredients of Nu-Lotan or Preminent, amlodipine or dihydropyridine drug, and thiazide drug or related drug (i.e., sulfonamide-containing "chlortalidone" medicines).
* Participant is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history within the last year of drug or alcohol abuse or dependence.
* Participant is pregnant or breastfeeding, or expecting to conceive OR the pregnancy test is positive at screening visit (Visit 1).
* Participant is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent.
Benefits of Exergames on Neurocognitive Functions in Adults Suffering From Depression

The purpose of this study is to analyse the changes derived from exergames (videogames that include cognitive and physical stimulation simultaneously), in terms of cognitive functioning, psychomotor abilities, and its neural substrate, in adults suffering from depression.

The experiment will consist in a randomized three-arms controlled study. After being informed about the study and potential risks, and given written informed consent, adult participants with depression will be randomly distributed into three experimental groups: an intervention group that will train with exergames, an active control group that will train only with cognitive games, and a passive control group or wait-list.

Cognitive Functions will be evaluated in three different moments: before the training intervention, after the intervention, and three months after finishing the training intervention.

Researchers will collect cognitive-behavioral and neural information (event-related potentials), and performing analysis of variance to compare the outcomes of the diverse groups at the three different time points, scientists will analyse the benefits of exergames on cognition.

Eligibility Criteria:
The inclusion and exclusion criteria for persons suffering from depression, will be validated by a professional (psychologist), through an interview and the use of reliable and valid psychological assessment tools.

Inclusion Criteria:

* Using the Beck Depression Inventory-Second Edition (BDI-II), a scored considered for inclusion criteria where depression (≥ 28 points on BDI-II), confirmed by psychological interview.
* A sufficient level of education to understand study procedures and be able to communicate with site personnel

Exclusion Criteria:

* Participants suffering from depression with comorbidities (bipolar disorder, obsessive-compulsion disorder, neurological disorder, or traumatic brain injury) will be excluded.
* \<20/60 vision with or without correction
* Inability to complete the activities
* Communication problems
Low Level Light Therapy (LLLT) for Hair Growth

A total of 62 participants will receive red light (660 nm) to the scalp through a specially designed light therapy device integrated into a conventional hat. Each treatment will be 30 min per session applied on every other day for 14 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects between the ages of 18 and 60 years
* Diagnosed AGA in the past 12 months for male (Fitzpatrick I-IV, Hamilton-Norwood IIa-V ) and female (Fitzpatrick I-IV, and Ludwig-Savin Baldness Scale I-2, I-3, I-4, II-1, II-2 baldness patterns)

Exclusion Criteria:

* Known Photosensitivity
* Using any oral or topical substance for hair growth
* Having Tattoo, hair transplantation, scalp reduction, malignancy or hair weave in the scalp are with alopecia
* Known medical conditions that could negatively affect hair growth, such as infections, connective tissue disease
* Currently or plan to be on a calorie-restricted diet during study participation
Studying Biomarkers in Samples From Younger Patients With Kidney Cancer

This laboratory study is looking into biomarkers in samples from younger patients with kidney cancer. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors find better ways to treat cancer.

PRIMARY OBJECTIVES:

I. To determine whether focal adhesion kinase (FAK) is expressed and if FAK is phosphorylated in pediatric renal tumors.

OUTLINE:

Archived tumor tissue samples are analyzed for FAK expression by immunohistochemistry (IHC). IHC staining is compared in normal renal tissue, Wilms tumor (routine and anaplastic), malignant rhabdoid tumor of the kidney, clear cell sarcoma of the kidney, and mesoblastic nephroma.

Eligibility Criteria:
Inclusion Criteria:

* Formalin-fixed, paraffin-embedded tissue samples from patients diagnosed with the following renal tumors:

  * Anaplastic Wilms tumor
  * Malignant rhabdoid tumor of the kidney
  * Clear cell sarcoma of the kidney
  * Mesoblastic nephroma
Nutritional Effect of an Amino Acid Mixture on Lean Body Mass (LBM) in Post-bariatric Surgery Patients

The Focus of this study is to look at the role of nutrition in maintaining lean body mass post-gastric bypass surgery. The purpose of this study is to test whether LBM is increased in those patients receiving a nutritional supplement of amino acids is enhanced when compared to control patients not receiving the supplement.

You are being asked to participate in a pilot (initial) research study designed to test how effectively a nutritional supplement, Juven, helps people keep lean muscle mass (the amount of muscle tissue in your body) and sustain weight loss after gastric bypass surgery. Abbott laboratories, the manufacturer of Juven, sponsors this research study. Juven is commercially available without prescription in the United States.

If you decide to participate, you will have a DEXA scan to check your lean body mass, an indirect calorimetry (your breath is collected for a period of time and is analyzed) test to check your basal metabolic rate (how much energy your body uses at rest), and a blood test to check your certain hormone made by your intestines (bowel or guts). Each of these tests will be run on you three times. Once, before your gastric bypass surgery, once 2 weeks after your surgery and once two months after your surgery.

If you qualify for the study, you will be randomly (like the flip of a coin) assigned by a computer to receive either Juven twice a day by mouth, or to continue with standard care.

As part of your normal post-operative instructions, you should avoid becoming pregnant for two years after your surgery. Acceptable forms of birth control after gastric bypass include barrier methods (condoms, diaphragm, etc.), Depo-Provera (the shot) and Nuva-Ring (Vaginal ring). The birth control pill is not as reliable after gastric bypass because its absorption is unpredictable. The effects of Juven in pregnant women have not been tested. If you should become pregnant, you should stop taking Juven and notify Dr. Clements or his staff.

Eligibility Criteria:
Inclusion Criteria:

* Each person who has been judged to be an acceptable candidate for laparoscopic gastric bypass (LGB) will be asked to participate in this protocol when they are scheduled for the operation.

Exclusion Criteria:

* Age less than 18
* Pregnant females
* Weight greater than the limit of the DEXA table (Patients over 300 pounds)
* Known allergy to any component fo the amino acid supplement
Effect of Kinesiotaping Versus Endurance Exercise on Postmenopausal Low Back Pain

This study will be conducted to determine the effect of kinesiotaping versus endurance exercise on postmenopausal low back pain.

Non-specific back pain is more frequent in women than men, mainly in postmenopausal women. High prevalence of hypovitaminosis D has been detected in postmenopausal women, and it is associated with decreased bone mass, sarcopenia, which can be related to back pain.

Postural control, can be defined as "the ability to maintain the body's center of gravity within the limits of stability as determined by the base of support , Differences in motor behavior between Low Back Pain (LBP) patients and healthy control subjects have been demonstrated in a variety of tasks, e.g. during walking and in response to several perturbations.

Published evidence indicates that LBP patients may have impaired control over trunk posture and movement, Dynamic controls is important in many functional tasks as it requires integration of appropriate levels of proprioception, range of motion, and strength. Endurance exercise is characterized by continues submaximal muscular contractions . It is an effective mean of maintaining or improving cardiovascular and musculoskeletal health, both of which are critical for preserving physiological functioning, independence and improving standing balance.

kinesiotape allows the joint to move through its full range of motion. It has also been reported to increase blood circulation and lymphatic drainage, which leads to a reduction of pain and stimulates large-fibre cutaneous mechanoreceptors that may inhibit proprioceptive impulses in the spinal column and decrease pain via an ascending pathway.

Eligibility Criteria:
Inclusion Criteria:

* A convenient sample of fifty postmenopausal women suffering from non-specific low back pain and postural instability was enrolled in this study.
* Praticipants were chosen healthy and medically stable.
* Their ages ranged from 50 - 60 years to be included in the study.
* Their body mass index (BMI) is not exceed 35 kg m2.
* All of them are diagnosed by the gynecologist.

Exclusion Criteria:

* They were excluded from the study if they had:
* Premature menopause or surgical menopause.
* Mental , neurological , vestibular , cardiovascular disorders, metabolic disease. -----
* Musculoskeletal disorders ( disc lesion , ankylosing spondylitis , rheumatoid arthritis , osteomalacia , spinal deformities, lumber vertebre fractures) .
A Study of PMPA in HIV-Infected Patients

The purpose of this study is to see if it is safe and effective to give PMPA to HIV-infected patients. This study also examines how the body handles PMPA.


Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Laboratory diagnosis of HIV infection.
* CD4 cell count \>= 200 cells/mm3 within 28 days prior to entry.
* Plasma HIV RNA \>= 10,000 copies/ml within 28 days of entry.
* Minimum life expectancy of 12 months.

Exclusion Criteria

Co-existing Condition:

Patients with any of the following symptoms or conditions are excluded:

* Active, serious infections (other than HIV) that require parental antibiotic therapy. Patients may be considered recovered if at least 2 weeks have elapsed following cessation of parental therapy before enrollment.
* Active clinically significant medical problems that include cardiac disease (e.g., symptoms of ischemia, congestive heart failure, or arrhythmia).
* Positive test for Hepatitis B surface antigen or Hepatitis C antibody in serum.

Patients with any of the following prior conditions are excluded:

History of malignancy other than basal cell carcinoma or cutaneous Kaposi's sarcoma.

Patients who are receiving:

* Antiretroviral therapy, including nucleoside analogs, non-nucleoside reverse transcriptase inhibitors, protease inhibitors or investigational antiretroviral agents.
* Interferon or interleukin therapy, aminoglycoside antibiotics, amphotericin B, cidofovir, diuretics, foscarnet, ganciclovir, itraconazole, fluconazole, ketoconazole (topical allowed), isoniazid, rifampin, rifabutin, clarithromycin, azithromycin, systemic chemotherapeutic agents, systemic corticosteroids, other agents with significant nephrotoxic potential, other agents that may inhibit or compete for elimination via active renal tubular secretion (probenecid) and other investigational agents.

Within 2 weeks prior to entry:

* Antiretroviral therapy, including nucleoside analogs, non-nucleoside reverse transcriptase inhibitors, protease inhibitors or investigational antiretroviral agents.
* Interferon or interleukin therapy, aminoglycoside antibiotics, amphotericin B, cidofovir, diuretics, foscarnet, ganciclovir, itraconazole, fluconazole, ketoconazole (topical allowed), isoniazid, rifampin, rifabutin, clarithromycin, azithromycin, systemic chemotherapeutic agents, systemic corticosteroids, other agents with significant nephrotoxic potential, other agents that may inhibit or compete for elimination via active renal tubular secretion (probenecid) and other investigational agents.

Active drug or alcohol abuse as demonstrated by a positive screening test for drugs of abuse (except marijuana or drugs used for medical indications), or substance abuse considered sufficient to hinder patient compliance.