cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial of the Combination of Intravenous Alvespimycin (KOS-1022), Trastuzumab With or Without Paclitaxel in Patients With Advanced Solid Tumor Malignancies or Her2 Positive Metastatic Breast Cancer Who Have Previously Failed Trastuzumab Therapy

To determine the Maximally Tolerable Dose (MTD) of KOS-1022 when administered weekly in combination with trastuzumab or in combination with trastuzumab and paclitaxel to patients with advanced solid tumor malignancies


Eligibility Criteria:
Inclusion Criteria:

* KPS performance status \>= 70%
* Schedule A: all patients must have a histologically confirmed solid tumor malignancy. Schedule B: patients must have metastatic breast cancer with Her2 amplification by FISH or 3+ Her2 overexpression by immunohistochemistry ("IHC"). Patients are not required to have measurable disease for this investigation. Disease must be assessed within 28 days prior to treatment initiation
* All Adverse Events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to NCI CTCAE (v. 3.0) Grade \<= 2 (except for alopecia)
* The following laboratory results, within 10 days of KOS-1022 administration:

  * Hemoglobin \>= 8.5 g/dL
  * Absolute neutrophils count \>= 1.5 x 10\*9\* /L
  * Platelet count \>= 75 x 10\*9\*/L
  * Serum bilirubin \<= 2 x ULN
  * AST and ALT \<= 2.5 x ULN
  * Serum creatinine \<= 2 x ULN

Exclusion Criteria:

* Documented hypersensitivity reaction of CTCAE Grade \>= 3 to prior therapy containing trastuzumab
* Pregnant or breast-feeding women. Male patients must be surgically sterile or agree to use an acceptable method of contraception
* Known active CNS metastases
* Administration of any other chemotherapy, biological, immunotherapy or investigational agent (therapeutic or diagnostic) within 14 days prior to receipt of study medication. Patients should be 6 weeks from last dose of nitrosourea
* Patients with Grade 2 or higher dyspnea at rest on room air; patients with other clinically significant pulmonary co-morbidity(s) that might predispose the patient to pulmonary toxicity
* Moderately severe dry eye
* Prior pulmonary toxic chemotherapy (e.g, bleomycin or carmustine)
* Congestive heart failure, or a left ventricular ejection fraction (LVEF)
* Any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient
* Patients with previous malignancies unless free of recurrence for at least 5 years except cured basal cell carcinoma of the skin, carcinoma-in-situ of either the uterine cervix or urinary bladder
Evaluation of the Effects of Using Cooling Pillowcases, on the Symptoms of Hot Flushes, Sleep and Life Quality

This study was planned to evaluate the effect of education on the management of side effects and the use of cooling pillowcase on hot flush complaints, sleep and quality of life in women with breast cancer receiving hormone therapy.

It is planned to apply pre-test evaluations in the 1st week and post-test evaluations in the 9th week to the intervention (training) group consisting of women with breast cancer who agree to participate in the study. A total of 3 follow-ups will be performed on the patients in the intervention (education) group in weeks 3 and 7 by telephone interview method and in week 5 by face-to-face interview method using the Patient Follow-up Form. In addition, in order to evaluate the effectiveness of the education given to the patients in the intervention (education) group, the Practices for Coping with the Side Effects of Hormone Therapy Form will be completed in the 5th and 9th weeks.

The control group consisting of women with breast cancer who agreed to participate in the study will be administered pre-test evaluations at week 1 and post-test evaluations at week 9. The patients in the control group will not be subjected to any intervention by the researcher, their routine treatment and care will continue, and they will be followed up only once in the 5th week by phone call.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older,
* Estrogen and progesterone receptor positive, stage 1, 2, 3 or 4 primary breast cancer,
* Receiving hormone therapy (goserelin acetate subcutaneously every 4 weeks),
* Pre/Perimenopausal period,
* No sensory and emotional barriers to communication,
* Understands Turkish, can read and write,
* Patients who voluntarily agreed to participate in the study.

Exclusion Criteria:

* Receiving treatment for anxiety and/or depression,
* Receiving gabapentin treatment for neuropathic pain,
* Active viral or bacterial infection,
* Patients with a history of sleep disorders diagnosed before hormone therapy.
Effects of Exercise and Exercise Counselling in Hemodialysis Patients.

The aim of the study is to determine the effect of functional exercise and training counseling by kinesiotherapist in addition to the basic exercise program of cycling during dialysis on physical performance of dialysis patients.

Study will include 86 dialysis patients. Investigators will first test the strength of lower limbs with sit-to-stand test, handgrip strength, flexibility, balance, submaximal aerobic capacity, physical characteristics and clinical parameters. After that randomization of patients in two groups will be made - one experimental and one active control group. Patients who will refuse to exercise will be invited to a non-randomized inactive control group (without exercise).

The experimental group will attend 3 times weekly a guided functional exercise before the dialysis procedure for 20 minutes and perform a cycling session during dialysis in the first phase of the study, which will last for 8 weeks. During this time experimental group will receive exercise counselling; instructions how to practice at home will be given by examples and training during functional exercise predialysis sessions.

In the second phase of the study for additional eight weeks participants will be instructed to exercise at home using the skills mastered during the first study phase on non-dialysis days, and continue with the program of intradialysis cycling. Investigators will give them advice, monitor and motivate them.

The active control group will perform intradialytic exercise (intradialysis cycling equal to cycling program of experimental group) during dialysis procedure for four months.

The primary end-point of the study is a change in the 10-repetition sit-to-stand test time as a measure of strength of lower extremities.

Exercise program will be run by a kinesiologist. Main hypothesis is that the guided functional exercise under the surveillance of a kinesiologist added to intradialysis cycling program statistically significantly improves patient's physical performance as compared to the program of intradialysis cycling alone.

Eligibility Criteria:
Inclusion Criteria:

* dialysis patients on renal replacement therapy with chronic hemodialysis,
* duration of hemodialysis treatment for at least 3 months,
* age 18-90 years,
* capable of independent walking and independent feeding.

Exclusion Criteria:

* the presence of chronic malignant or infectious disease,
* uncontrolled arterial hypertension with an average of the last five pre-dialysis blood pressure values above 180/100 mm Hg,
* unstable angina pectoris or Canadian Cardiovascular Society class 2-4,
* heart failure New York Heart Association class 3 and 4,
* the presence of a psychotic illness or a mental disability,
* a condition with an amputated limb (more than 2 fingers on the lower limb and / or more than 2 fingers on the upper limb)
* any other condition that causes the clinical unstability of the patient (i.e. repetitive gastrointestinal hemmorrhagies, liver cirrhosis with frequent exacerbations, advanced dementia with poor cooperation of the patient)
Liraglutide Effect in Atrial Fibrillation

The goal (or purpose) of this study is to evaluate (study) a new way to stabilize (steady) the activity between the fat deposits surrounding the heart and the left atrium.

To reduce the amount of EAT, this study will use a medication called Liraglutide. This medication is known to work on fat deposits and produce weight loss. The investigator is conducting this study to find out if Liraglutide will reduce the fat deposits surrounding the participant's heart, and stabilize (and perhaps reduce or eliminate) atrial fibrillation activity.


Eligibility Criteria:
Inclusion Criteria:

* Male and female, age 18 or older
* Persistent AF defined as continuous AF sustained beyond 7 days (or AF with the decision to cardiovert before 7 days of enrollment or Paroxysmal AF defined as recurrent AF (≥2 episodes) that terminates spontaneously within 7 days
* BMI ≥27 kg/m2
* Patient wishes to undergo a catheter ablation procedure for the treatment of atrial fibrillation
* Receiving follow-up care at the University of Miami

Exclusion Criteria:

* Inability to sign an informed consent
* Patients with longstanding persistent atrial fibrillation of more than 3 years
* Prior ablation for atrial fibrillation
* Patients not appropriate candidates for catheter ablation such as those with AF due to acute or chronic precipitating medical conditions, for example, hypothyroidism and hyperthyroidism, significant pulmonary disease, pulmonary embolism, left atrial thrombus, class IV heart failure)
* Patients with a life expectancy \<1 year
* Patients with a serious medical condition (for example, recent cancer with chemotherapy or radiation therapy within 4 weeks before entering the study) who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
* Known contraindications to Liraglutide, such as the previous history of pancreatitis or medullary thyroid carcinoma
* Personal or family history of multiple endocrine neoplasias
* Known serious hypersensitivity reaction to Liraglutide
* Patients using, glitazones, sodium-glucose transporters 2 inhibitors (SGLT2i), other GLP-1 analogs, or DPP4 inhibitors
* Type 1 diabetes, defined by American Diabetes Association criteria, history of diabetic ketoacidosis, pancreas or beta-cell transplantation, or diabetes due to pancreatitis or pancreatectomy
* Poorly controlled type 2 diabetes with HbA1c \> 10%
* Pregnant women
* Women who are breast-feeding or intend to become pregnant
Mechanisms of Insulin Resistance in Humans

The Objectives of the study are to: (1)compare the inflammatory response and insulin resistance in skeletal muscles during a systemic infusion of lipid with that during a local infusion of lipid into the femoral artery. which would cause minimal or no systemic hyperlipidemia but local plasma free fatty acid (FFA) concentrations similar to those during the systemic lipid infusion, and (2) determine the inflammatory response and insulin resistance in skeletal muscle during an infusion of lipid into the femoral artery as described above after NF-KB inhibition by high dose salicylate treatment in humans.

Insulin resistance in skeletal muscle is a characteristic abnormality in obesity and the metabolic syndrome and a major factor responsible for the development of type 2 diabetes. Although the mechanisms responsible for muscle insulin resistance are largely unclear, lipid oversupply is an important factor. Among numerous potential mechanisms whereby lipid oversupply may cause muscle insulin resistance, current evidence points towards inflammation as being critical. Recent studies in animals, however, indicate that the inflammatory response in skeletal muscles may require the presence of circulating pro-inflammatory factors suggesting that the inflammation induced insulin resistance in skeletal muscles may be a secondary event. More specifically, activation of Nuclear Factor-Kappa B(NF-kB), and inflammatory master switch that drives the production of numerous pro-inflammatory cytokines in fat and liver, has been implicated in causing insulin resistance in skeletal muscles by increasing circulating pro-inflammatory cytokines. In contrast, animal studies have found that activation of NF-KB directly in skeletal muscles has no or little effect on its insulin sensitivity but does produce other abnormalities such as increased proteasome activity. The study shall therefore be undertaken to determine to what extent lipid-induced inflammation and insulin resistance in skeletal muscles requires the presence of circulating proinflammatory factors in humans.

Eligibility Criteria:
Inclusion Criteria:

* two groups of 16 healthy subjects

Exclusion Criteria:

* diabetes or impaired glucose tolerance
* peripheral vascular disease
* pulmonary disease
* clinically significant hepatic or renal disease
* triglycerides \>200mg/dl
* anemia
* abnormal PT, PTT or INR
* pregnancy or lactation
Safety and Efficacy Study of ELND005 as an Adjunctive Maintenance Treatment in Bipolar I Disorder

The primary purpose of this study is to determine whether ELND005 is effective in the maintenance treatment of bipolar 1 disorder when added to other therapies.


Eligibility Criteria:
Inclusion Criteria:

* Meets the DSM-IV-TR criteria for BPD I by the SCID, prior to the Screening Visit.
* Has a history in the last 3 years of ≥ 1 manic or mixed episodes of sufficient severity that required hospitalization and/or treatment with a mood stabilizer or antipsychotic, or confirmed by a family member or medical records to ensure the episode fulfills the DSM-IV-TR criteria.
* Has experienced a mood episode of any polarity within 4 months prior to the Screening Visit and responded to StOC therapy.
* Is euthymic at the Screening Visit (ie, score of ≤ 12 on the MADRS and a score of ≤ 12 on the Y-MRS).
* Is receiving maintenance treatment for his or her BPD I with either LTG or VPA; on stable doses for past 4 weeks and therapeutic drug levels (total VPA 50--125 µg/mL and LTG 10-50 µmol/L or as deemed appropriate by the investigator). Dose adjustments made for tolerability reasons will be acceptable.

A study patient must meet the following additional criteria to be eligible for randomization in the Double-blind Randomization Phase of this study:

- Maintained in a stable euthymic state during Phase 1, defined as Y-MRS and MADRS scores of ≤ 12, with the following exceptions: a maximum of 2 nonconsecutive excursions will be allowed throughout Phase 1. Excursions are defined as Y-MRS or MADRS scores \>12 but ≤ 16.

Exclusion Criteria:

* Woman of childbearing potential who is unwilling or unable to use an acceptable method of birth control or is using a prohibited contraceptive method.
* Is found to be actively suicidal on the C-SSRS (answer of "yes" to question 4 or 5 \[current or over the last 30 days\]) or a score of ≥4 on the MADRS item 10 at the Screening Visit.
* Has suboptimally treated thyroid disease as evidenced by thyroid-stimulating hormone (TSH) \>3 mIU/L at the Screening Visit.
* Has received electroconvulsive therapy (ECT) during the current episode or within 6 months prior to the Screening Visit.
* Has an estimated glomerular filtration rate \<40 mL/min/1.73 m2 according to the Modification of Diet in Renal Disease formula.

A study patient who meets ANY of the above and ANY of the criteria below will not be eligible for enrollment in the Double-blind Randomization Phase of this study:

* Has current signs or symptoms of psychosis.
* Has become actively suicidal as defined by C-SSRS answer of "yes" to question 4 or 5 (current or over the last 30 days) and/or has a score of ≥4 on MADRS item 10.
Efficacy of a Home-based Stretching Program on Fibromyalgia Symptoms: a Randomised Controlled Trial

This randomised controlled trial will examine the clinical efficacy of a six-week, novel, home-based stretching programme compared to usual care on the effect of symptoms experienced by patients with fibromyalgia.


Eligibility Criteria:
Inclusion Criteria:

* individuals diagnosed with fibromyalgia in accordance with the ACR 2016 diagnostic criteria.
* individuals diagnosed with chronic non-malignant pain or individuals diagnosed with chronic widespread pain (including fibromyalgia syndrome) are also included when they meet the ACR 2016 diagnostic criteria.

Exclusion Criteria:

* Non-controlled systemic disorders (such as hypertension, diabetes and coronary insufficiency),
* neurological conditions that impair alertness or comprehension, musculoskeletal conditions that could compromise assessments (such as nerve root compression or knee joint inflammation),
* relevant joint disorders (such as severe arthritis, arthroplasty of the hip or knee, and rheumatoid arthritis),
* recent changes in therapy for fibromyalgia (i.e., within four weeks of baseline).
Results of Cervical Segmental Mobilization in Patients With Chronic Lateral Epicondylitis

The aim of our study was to investigate the effect of cervical segmental mobilization on pain, functionality, grip strength and quality of life in patients with chronic lateral epicondylitis. It was planned as a randomized controlled experimental study.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 25-44
* Being diagnosed with LE by a physician
* Not having any defined pathology in the cervical region
* No neurological problems in the upper extremities
* No history of cervical surgery

Exclusion Criteria:

* Those with a history of infection, tumor, trauma in the cervical area
* Fibromyalgia patients
* Congenital or acquired deformities of the upper extremity
* History of shoulder or elbow surgery or dislocation
* Cervical radiculopathy
* Having had Wiplash
Ice Immersion Using Virtual Reality & Augmented Reality

The purpose of this study is to evaluate the effectiveness of different technologies, Virtual Reality and Augmented Reality with modifications as passive content, active content, cognitive load modulation, and positive encouragement coaching to increase the pain threshold as assessed by immersing a hand in ice water.


Eligibility Criteria:
Inclusion Criteria:

* Greater than 18 years of age
* English speaking
* Hearing intact

Exclusion Criteria:

* Patients who do not consent
* Currently taking beta blockers or other chronotropic heart medication(s)
* Have a history of severe motion sickness
* Currently have nausea
* Currently experiencing seizures
* Are clinically unstable
* Have taken pain medications in the last 12 hours
Safety Study of Use of Autologous Bone Marrow Derived Stem Cell in Treatment of Age Related Macular Degeneration

The purpose of this Phase I/II study is to investigate the safety and preliminary efficacy of unilateral intravitreally transplantation of adult bone marrow stem cells in subjects with geographic atrophy secondary to age-related macular degeneration.

This study is an open-label investigation of the safety and preliminary efficacy of unilateral intravitreal injection of autologous bone marrow stem cells in subjects with Geographic Atrophy secondary to Age-Related Macular Degeneration (AMD). Subjects will be enrolled based on specific inclusion/exclusion criteria and evaluated at regular post transplant intervals.

Human central nervous system -stem cells will be transplanted by a vitreoretinal surgeon. The transplantation will be conducted in the eye with the inferior best-corrected visual acuity (BCVA) (i.e., the Study Eye). Only the Study Eye will undergo transplantation. The adult bone marrow stem cells will be administered into the vitreous cavity through a standard surgical approach.

Moxifloxacin 300 mg(once per day ) will be administered orally to all subjects for a period of five days ( 2 days pre and post operatively) .

Subjects will be monitored frequently for a total of one year after adult bone marrow stem cells cell injection .

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of age-related macular degeneration with geographic atrophy (GA)
* Only patients with a specific degree and extent of GA will be eligible
* Subjects with best-corrected visual acuity (BCVA) of less than or equal to 20/400 in the Study Eye
* No prior or current choroidal neovascularization in either eye
* Able to provide written informed consent prior to any study related procedures
* Agree to comply in good faith with all conditions of the study and to attend all required study visits

Exclusion Criteria:

* Prior vitreal or retinal surgery in the previous 6 months
* Glaucoma
* Atrophic macular disease of any other cause
* Diabetic retinopathy or diabetic macular edema in either eye
* Previous organ, tissue or bone marrow transplantation
* Autoimmune disease
* Allergy to moxifloxacin
* Current or prior malignancy (or is on chemotherapy)
Parallel Arm Trial of AD109 and Placebo With Patients With OSA (LunAIRo)

This is a Phase 3 Randomized Double-Blind Placebo-Controlled 1-year Parallel-Arm Study to Compare a Fixed Dose Combination of AD109 to Placebo in Obstructive Sleep Apnea.


Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years of age at the time of informed consent.
2. PSG criteria: AHI of \>5; ≤ 25% central or mixed apneas; and PLM arousal index ≤15
3. PROMIS-Fatigue: raw score ≥17
4. PAP intolerance or current PAP refusal.
5. BMI between 18.5 and 40 kg/m2 for men, or 42 kg/m2 for women, inclusive.

Exclusion Criteria:

1. Narcolepsy, restless leg syndrome, REM sleep behavior disorder
2. Insomnia disorder characterized by difficulty initiating or maintaining sleep, or use within the past month of sedative-hypnotics or other medication for the purpose of treating or avoiding insomnia symptoms.
3. Pierre Robin, Treacher Collins, or other craniofacial malformation syndrome, or grade ≥3 tonsillar hypertrophy.
4. Clinically significant cardiac disease, e.g., ventricular arrhythmia, untreated or unstable coronary artery disease, cardiac failure. Stable atrial arrhythmia is allowed.
5. Neuromuscular disorder (e.g., motor neuron disease, muscular dystrophy or myopathy, myasthenic syndrome); epilepsy; Parkinson, Alzheimer, or other neurodegenerative disease.