Kornimate/medical-research-clean huggingface dataset:
effectiveness of antidepressant treatment for depression in people with parkinson's disease

Conditions: Depressive Disorder; Parkinson Disease

Summary: this study will evaluate the effectiveness of atomoxetine in reducing symptoms of depression in people with parkinson's disease.

depression is a serious medical condition that affects people's thoughts, feelings, and ability to function in everyday life. depression can happen to anyone, but it is more of a risk in people with parkinson's disease, a progressive brain disorder that is caused by a loss of dopamine-producing brain cells. as many as half of people with parkinson's may suffer from depression. these individuals experience different symptoms than those who have depression alone. for example, they are prone to higher rates of anxiety, sadness without guilt or self-blame, and lower suicide rates despite high rates of suicidal thoughts. depression treatment can help people with parkinson's disease who are depressed to manage both diseases and improve the quality of their lives. this study will evaluate the effectiveness of atomoxetine, an antidepressant medication, in reducing symptoms of depression in people with parkinson's disease. participants in this double-blind study will be randomly assigned to receive either atomoxetine or placebo for 8 weeks. all participants will report to the study site at baseline and weeks 2, 4, and 8. psychiatric, neuropsychological, and neurological assessments will be performed, including evaluations with the inventory of depressive symptomatology (ids) scale and the clinical global impression-improvement (cgi-i) scale. all participants will be offered continued routine psychiatric care with the study physician upon completion of the study.

Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic parkinson's disease * ids score greater than 21 * mini-mental state examination (mmse) score greater than 15 exclusion criteria: * recent deep brain stimulation * currently participating in an antidepressant trial at a less than adequate dose and duration * severe depression or depression with suicide ideation * history of liver toxicity * unstable medical disease or comorbid psychiatric disease

Keywords: depression parkinson's disease atomoxetine
a study of fcx-007 for recessive dystrophic epidermolysis bullosa

Conditions: Recessive Dystrophic Epidermolysis Bullosa

Summary: the purpose of this study is to determine whether administration of fcx-007 in addition to standard of care improves wound healing as compared to standard of care alone (control) in children, adolescents, and adults with recessive dystrophic epidermolysis bullosa. funding source - fda oopd

defi-rdeb is a multi-center, intra-patient randomized, controlled, open-label, phase 3 study of fcx-007 for the treatment of persistent non-healing and recurrent rdeb wounds in approximately 24 subjects. each subject will serve as his/her own control. each subject's target wounds will be paired then randomized to receive fcx-007 (treatment wound) or remain untreated (control wound). up to three target wound pairs will be identified for each subject. subjects will receive intradermal injections of fcx-007 in each specified treatment wound in two or more treatment sessions. the first treatment session occurs at day 1 and the second at week 12/month 3. additional treatment sessions may occur at week 24/month 6 and week 36/month 9 when unclosed treatment wounds may be re-treated, and unclosed control wounds may be treated. safety and efficacy assessments will occur at scheduled intervals through week 48/month 12, when the treatment period is completed, and a long-term safety follow-up period (through 15 years) commences for subjects who have received one or more fcx-007 injections.

Eligibility criteria:
key inclusion criteria: * male or female ≥2 years of age at the screening visit. * clinical diagnosis of rdeb with confirmation of col7a1 genetic mutation. key exclusion criteria: * medical instability limiting ability to travel to the investigative site. * active infection with human immunodeficiency virus, hepatitis b or hepatitis c. * the presence of col7 antibodies. * evidence of systemic infection. * evidence or history of squamous cell carcinoma at the site to be injected. * evidence of or history of metastatic squamous cell carcinoma. * known allergy to any of the constituents of the product. * female who is pregnant or breastfeeding. * receipt of a chemical or biological intervention for the specific treatment of rdeb in the past three (3) months prior to screening or anticipated/planned during the screening and treatment period for this study.

Keywords: rdeb
continuous infusion of campath-1h followed by subcutaneous injections in previously treated patients with chronic lymphocytic leukemia

Conditions: Chronic Lymphocytic Leukemia

Summary: the goal of this clinical research study is to learn if giving campath-1h first as an injection into a vein, then as an injection under the skin can shrink or slow the growth of the disease in patients with chronic lymphocytic leukemia (cll) who have already received standard therapy. another goal is to learn if the side effects related to campath-1h treatment are less severe by giving the drug first as an injection into a vein then as an injection under the skin.

the purposes of this trial are: 1. to evaluate the response rate (cr+pr) to campath-1h given as continuous infusion followed by subcutaneous injection in patients with previously treated cll who have failed fludarabine therapy. 2. to evaluate whether campath-1h, given as a continuous infusion followed by subcutaneous injections to patients with previously treated cll will improve tolerability of the agent and permit higher doses to be delivered through that route. 3. to evaluate the pharmacokinetics of campath-1h when given as a 24 hour continuous infusion followed by a subcutaneous injection.

Eligibility criteria:
inclusion criteria: * age \>= 18 years (cll does not occur in the pediatric population). * signed informed consent. * world health organization (who) performance status of 0, 1, or 2. * patients with b-cll who have received fludarabine and are either refractory to frontline therapy or have relapsed within six months from receiving fludarabine-based therapy. patients previously treated with campath-1h are eligible. * serum creatinine \<= 2mg/dl, total bilirubin \<= 2mg/dl, and sgpt \<= 3x upper limit of normal (uln) unless due to direct infiltration of the liver or kidney with malignant cells. exclusion criteria: * past history of anaphylaxis, following exposure to rat or mouse derived cdr-grafted humanized monoclonal antibodies. * prior chemotherapy, immunotherapy, or hormonal therapy within 2 weeks prior to study start. hormonal replacement therapy is permitted. prior therapy with monoclonal antibodies for at least 4 weeks prior to study start. * pregnant or nursing women or any patient of childbearing age unwilling to practice an acceptable form of contraception. * patients with history of hiv positivity. * active secondary malignancy. * active uncontrolled infection or any major systemic or other illness that would, in the opinion of the investigator, interfere with the patient's ability to comply with the protocol, compromise patient safety or interfere with the interpretation of study results.
investigating how cagrisema, semaglutide and cagrilintide regulate insulin effects in the body of people with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this study will look at how cagrisema, semaglutide and cagrilintide regulate insulin effects in the body of people with type 2 diabetes (t2d). cagrisema is a new investigational medicine that combines two medicines called cagrilintide and semaglutide. doctors may not yet prescribe cagrisema. participants will either get cagrisema, semaglutide, cagrilintide, or a ''dummy'' medicine. which treatment the participants will get is decided by chance. participants will get the study medicine together with the current daily diabetes medicine metformin. participants should not take other medicines for diabetes during the study. the study will last for about 42 weeks.


Eligibility criteria:
inclusion criteria: * male or female. * aged 18-75 years (both inclusive) at the time of signing informed consent. * diagnosed with type 2 diabetes greater than or equal to (\>=) 180 days before screening. * stable daily dose(s) of metformin at effective or maximum tolerated dose, as judged by the investigator for 90 or more days before screening with or without one additional oral antidiabetic drug (oad), except for the use of glucagon-like peptide-1 (glp-1) receptor agonists, or sodium-glucose co-transporter-2 (sglt-2) inhibitors in case of a high risk of cardiovascular disease (as judged by the investigator), or established cardiovascular disease, or chronic kidney disease (glomerular filtration rate (egfr) less than (\<) 60 milliliter per minute per 1.73 square meter \[ml/min/1.73 m\^2\]). * glycated hemoglobin (hba1c) at screening of 6.5-9.5 percent (48-80 millimoles per mole \[mmol/mol\]) (both inclusive) if on metformin only, or 6.0- 9.0 percent (42-75 mmol/mol) (both inclusive) if on metformin in combination with one other oad. a minimum of 65% of randomised participants must have hba1c \>= 7.0 % at screening. * body mass index (bmi) between 25.0 and 45.0 kilogram per square meter (kg/m\^2) (both inclusive) at screening. exclusion criteria: * female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method. * uncontrolled and potentially unstable diabetic retinopathy or maculopathy. verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. * renal impairment with estimated glomerular filtration rate (egfr) \< 45 ml/min/1.73 m\^2 at screening. * treatment with any medication for the indication of t2d or weight management other than stated in the inclusion criteria within 90 days before screening. however, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed.
observational study of insulin resistance and muscle wasting after burn injury

Conditions: Burn

Summary: the purpose of this study is to examine important and significant problems, that of insulin resistance and muscle wasting after burn injury.

burn injury induces insulin resistance and our investigators have previous shown the importance of insulin receptor substrate 1 (irs-1)-mediated pathways. this project will establish the inhibitory effects of burn injury on irs-1 mediated signaling in human skeletal muscle of burn patients.

Eligibility criteria:
inclusion criteria: * burn injury \>=10% total body surface area involvement from any etiology that will require surgical treatment * age 18 years or older * admitted to the massachusetts general hospital within 30 days of burn injury * patient or guardian who is capable of giving full informed consent exclusion criteria: * decision not to treat due to severity of injury * presence of anoxic brain injury that is not expected to result in complete recovery * existence of co-morbid conditions of malignancy currently under treatment, medical condition requiring glucocorticoid treatment, insulin dependent diabetes mellitus, morbid obesity defined as body mass index \>= 40

Keywords: burn
foot/hand neuromodulation for overactive bladder (oab)

Conditions: Overactive Bladder

Summary: the purpose of this study is to determine if electrical stimulation of the foot is effective in the treatment of overactive bladder conditions.

foot neuromodulation is designed to treat oab conditions by electrically stimulating the somatic afferent nerves in the foot using skin surface electrodes. the foot stimulation is non-invasive, can be performed at home, and has no adverse effects. foot neuromodulation therapy will likely be accepted by more patients and have the potential to make a broader impact on the improvement of oab conditions.

Eligibility criteria:
inclusion criteria: 1. 18 year old men and women and older 2. currently having overactive bladder (oab) symptoms, i.e. urgency, frequency, or incontinence 3. no evidence of neurological disorder or urinary tract infection, i.e. clinically diagnosed as idiopathic oab exclusion criteria: 1. pregnant women in their late pregnancy phase will be excluded because the increasing size of the baby/uterus may cause overactive bladder. 2. patients with implanted electrical stimulators such as pacemaker will be excluded for potential interference with the tens stimulator. 3. patients who are allergic to cipro or bactrim will be excluded from the cmg study.
closed loop stimulation, cognitive performance, and quality of life in pacemaker patients

Conditions: Cardiac Pacing, Artificial

Summary: the purpose of this study is to compare the influence of accelerometer-based rate adaptation and closed loop stimulation on cognitive performance and quality of life in pacemaker patients.

within the scope of a usual follow-up schedule the influence of the mode of rate-adaptation on cognitive performance of pacemaker patients will be analysed. accelerometer sensor will be compared with closed loop stimulation over 2 years. the cognitive performance will be measured by means of a standardized psychometric test. the occurrence of atrial fibrillation and serious adverse events, patient self-assessment and quality of life will be evaluated. an analysis of the telemonitored (home monitoring) data will be performed in order to identify predictors of changes or differences in cognitive performance.

Eligibility criteria:
inclusion criteria: * patients with a cylos pacemaker (implantation within the last 3 to 6 weeks) * closed loop stimulation mode activated since pre-hospital discharge * patients with chronotropic incompetence according to physician's judgment * maximum sinus rate \< 100 beats per minute (bpm) or percentage of atrial pacing ≥ 25% * patients suitable for rate-adaptive pacing for at least 2 years * patient informed consent exclusion criteria: * age under 55 * pregnant and breast-feeding women * patients who are already enrolled in another study

Keywords: pacing rate-adaptive quality of life cognitive performance atrial fibrillation pacemaker sensor
optical and biochemical biomarkers in early pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the purpose of this study is to develop a test for detection of pancreatic cancer by looking at the subject's dna.

pancreatic juice collection is performed by intravenous injection of fda approved synthetic human secretin (chirhoclin inc., burtonsville, md) at a dose of 0.2 µg/kg will be administered while the endoscope is positioned in the second portion of the duodenum. from within the duodenum and without cannulation of the papilla of vater, a 2.3-mm plastic aspiration catheter (olympus, tokyo, japan) will be passed through the biopsy channel of the endoscope until visible on screen in the endoscopic monitor. once active visible secretion via the papilla has begun, the first 10 ml of pancreatic juice will be collected via suctioning. this entire process from secretin injection to sample collection takes an average of 5 minutes. the sample is then aliquoted into 2 ml ampules, which are snap-frozen in liquid nitrogen (or portable rapid-freeze freezer) and freezer-stored until the assays are performed. the top 10 candidate markers from discovery and validation on tissue (aucs \>0.95) and from pilot pancreatic-juice testing (aucs \>0.9) will be evaluated in this study. following extraction from an equivalent of 0.4 ml pancreatic juice, dna will be bisulfite treated using optimized methods. then, an assay of aberrant methylation on target genes will be conducted using the quarts technique. results will be normalized to either a human dna marker (eg, beta-actin) or a methylated dna marker identified for normal pancreatic epithelium.

Eligibility criteria:
inclusion criteria: * patients who are referred for the evaluation of pancreas cancer, pancreatic cystic neoplasm, and family history of pancreas cancer. * international normalized ratio (inr) less than 1.5 * platelet count \>50,000 exclusion criteria: * any medical condition that preclude the patient from having a therapeutic procedure regardless of the endoscopic ultrasound (eus) finding * pregnant patients
a safety and efficacy study of inc280 alone, and in combination with erlotinib, compared to chemotherapy, in advanced/metastatic non-small cell lung cancer patients with egfr mutation and cmet amplification

Conditions: Non-Small Cell Lung Cancer

Summary: the purpose of this study was to determine the maximum tolerated dose (mtd) or recommended phase ii dose (rp2d) of inc280 in combination with erlotinib in the phase ib of this study, and to assess the anti-tumor activity and safety of inc280 alone, and in combination with erlotinib, versus platinum with pemetrexed in the phase ii of this study, in adult patients with egfr mutated, cmet amplified, advanced/metastatic non-small cell lung cancer with acquired resistance to prior egfr tki.

the decision was taken to halt study enrollment with cohort #3 in phase ib. therefore, activities for the planned phase ii were not initiated. this decision to stop further development of this combination was taken due to the challenge for enrollment in this very rare patient population along with the rapidly evolving disease landscape setting.

Eligibility criteria:
inclusion criteria: * locally advanced or metastatic nsclc * egfr mutation (l858r and /or ex19del) * cmet amplification by fish (gcn ≥ 6), * acquired resistance to egfr tki (1st or 2nd generation) * ecog performance status (ps) ≤ 1. exclusion criteria: * prior treatment with 3rd generation tki * phaseii : prior treatment with any of the following agents: * crizotinib, or any other cmet inhibitor or hgf-targeting inhibitor. * concomitant egfr tki and platinum based chemotherapy as first line regimen. * platinum-based chemotherapy as first line treatment

Keywords: non-small cell lung cancer nsclc inc280 erlotinib advanced/metastatic non-small cell lung cancer egfr mutation cmet amplification egfr tyrosine kinase inhibitor (egfr tki)
development and validation of the kansas city cardiac dysautonomia questionnaire (kcdysq)

Conditions: Cardiac Dysautonomia

Summary: main aim will be to compare in patients with cardiac dysautonomia, newly developed disease specific questionnaire to established generalized sf-36 and eq-5d questionnaires, as there are no disease specific questionnaires for comparison. these novel and established questionnaires will then be compared among groups who have relatively stable disease or stable symptoms with patients who will be expected to have a change in symptoms and qol.

with the advent of other disease specific questionnaires in patients with cardiac disease such as the afeqt questionnaire, patients with cardiac dysautonomia have a unique symptom set that can range from mild symptoms to debilitating on a daily scale. given that they are an underdiagnosed population who often have considerable rates of misdiagnosis, diagnostic delay, and concurrent life limiting factors not addressed by previous qol assessments, the next logical step therefore is the development and further validation of a qol questionnaire that serves to respect and represent the 6 domains of qol as stated by the who, with representation of all four health related qol (hrqol), as well as focus on underrepresented areas of patients with cardiac dysautonomia. a novel disease specific kcdysq questionnaire with questions being gathered from an extensive literature review of qol measures in this subset of patients as well as interviews and personal interactions with these patients is proposed. it will begin with a 100-item questionnaire and proceed to use a power analysis to further stratify this. for validation of this questionnaire, it is proposed to prospectively recruit all patients with a diagnosis of pots, ist, or vvs in a single center, and stratify them into patients with a new diagnosis/untreated pots, ist, or vvs compared with patients who have had symptoms improvement with medication or stable disease who present for routine follow ups. though an emerging technique and therefore a small but important percentage of this population, patients who have underwent sinus node manipulation for treatment of their ist or pots as well will also be included, as these subsets of patients have undergone little prior evaluation.

Eligibility criteria:
inclusion criteria: patients with a diagnosis of pots, ist, or vasovagal syncope exclusion criteria: patients with comorbid chronic conditions causing significant impairments in quality of life, defined as: * nyha class iii or iv heart failure * copd gold 3 or 4, group c or d * any patients with current malignancy not in remission * any patient with history of autoimmune disease requiring chronic steroid therapy or immunomodulatory agents: rheumatoid arthritis, lupus, sarcoidosis, psoriasis all patients with esrd requiring hemodialysis all patients with cirrhosis of any origin any patients with solid organ or bone marrow transplant requiring immunosuppressive therapy
long-term follow-up of arthroscopic biceps tenotomy and subacromial decompression in chronic massive rotator cuff tears

Conditions: Rotator Cuff Tears

Summary: chronic massive rotator cuff tears (mmrcts) are a significant orthopedic challenge, often leading to significant shoulder pain and functional impairment. while surgical intervention is a common treatment approach, long-term outcomes and the optimal surgical technique remain debatable. arthroscopic debridement, subacromial decompression, and biceps tenotomy are frequently employed procedures, but their long-term effectiveness in managing mmrcts is not fully understood. a comprehensive understanding of the long-term outcomes of these procedures is crucial for guiding clinical decision-making and patient counseling. the study aims to evaluate the long-term clinical and functional outcomes of arthroscopic debridement, subacromial decompression, and biceps tenotomy in patients with chronic massive rotator cuff tears. by analyzing a cohort of patients who underwent these procedures, we will assess factors influencing long-term outcomes, such as patient demographics, preoperative functional status, and surgical technique. furthermore, we will compare the long-term results of this surgical approach to other treatment modalities, including open repair and conservative management.


Eligibility criteria:
inclusion criteria: * patient who had arthroscopic debridement with subacromial decompression and biceps tenotomy without rotator cuff repair for chronic massive rotator cuff tears exclusion criteria: * patient who hadn't met the requirements for arthroscopic debridement with subacromial decompression and biceps tenotomy without rotator cuff repair for chronic massive rotator cuff tears