Kornimate/medical-research-clean huggingface dataset:
managed access programs for pkc412, midostaurin

Conditions: FMS-Like Tyrosine Kinase 3 (FLT3)-Mutated Acute Myeloid Leukemia; Acute Myeloid Leukemia; Aggressive Systemic Mastocytosis; Mast Cell Leukemia; Systemic Mastocytosis With an Associated Hematologic Neoplasm

Summary: the purpose of this registration is to list managed access programs (maps) related to pkc4, midostaurin.

* cpkc412a2001x - no longer available- an open-labeled, multi-center, expanded treatment protocol (etp) of midostaurin (pkc412) in patients 18 years of age or older with newly-diagnosed flt3-mutated acute myeloid leukemia (aml) who are eligible for standard induction and consolidation chemotherapy * cpkc412aus56x - no longer available - an open-label, multi-center, expanded treatment protocol of midostaurin (pkc412) in adult patients with newly diagnosed fms-like tyrosine kinase receptor (flt3) mutated acute myeloid leukemia (aml) who are eligible for standard induction and consolidation chemotherapy. * cpkc412a2407i - no longer available- managed access program (map) cohort treatment plan cpkc412a2407i to provide access to midostaurin (pkc412) for patients 18 years of age and older with newly-diagnosed flt3-mutated aml and eligible for induction and consolidation chemotherapy * cpkc412d2001m - no longer available- managed access program (map) to provide access to midostaurin (pkc412), for an individual patient with aggressive systemic mastocytosis (asm), mast cell leukemia (mcl) or mast cell sarcoma (mcs)

Eligibility criteria:
inclusion criteria: * an independent request should be received from a licensed physician (in some instances from health authorities, institutions or governments). * the patient has a serious or life-threatening disease or condition and no comparable or satisfactory alternative therapy is available for diagnosis, monitoring or treatment; patient is not medically eligible for available treatment alternatives or has exhausted all available treatment options. * the patient is not eligible or able to enroll in a novartis clinical trial or continue participation in a novartis clinical trial. * there is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated. * the patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in a country (as applicable). * provision of the product will not interfere with the initiation, conduct or completion of a novartis clinical trial or overall development program. * managed access provision is allowed per local laws/regulations.

Keywords: flt3-mutated aml aml aggressive systemic mastocytosis mast cell leukemia systemic mastocytosis with an associated hematologic neoplasm map manage access program pkc412 midostaurin
protected versus early weight bearing post microfracture surgery

Conditions: Defect of Articular Cartilage

Summary: to test using a randomised control trial, whether conservative rehabilitation and protected weight bearing versus early weight bearing and accelerated rehabilitation affects patient outcomes post microfracture surgery of the knee.

to test using a randomised control trial, whether conservative rehabilitation and protected weight bearing versus early weight bearing and accelerated rehabilitation affects patient outcomes post microfracture surgery of the knee. current practice in most units is to protect patients from weight bearing prior to entering a conservative physiotherapy rehabilitation program following microfracture surgery of the knee. at our unit we believe that protecting patients from weight bearing post microfracture surgery makes no difference to their outcome and only leads to a longer rehabilitation time and a delayed return to work and sports. therefore we want to randomise patients who require microfracture surgery of the knee for cartilage defects into 2 post operative rehabilitation groups. one group will be able to weight bear early and will undergo an accelerated rehabilitation program whilst the other will be protected from weight bearing and will undergo a more conservative rehabilitation program. we will then follow patients up over a year and compare outcome data collected at 6 weeks, 3 months, 6 months and 1 year post operatively to see if there was any difference in outcomes between the 2 groups. as secondary outcomes we will also compare the patients in the two groups to see if there is a difference in time taken to return to work and sporting activities

Eligibility criteria:
inclusion criteria: * aged 16-60 years. mechanically stable knee joint at outpatient examination. mri confirmed grade 3 or 4 non-kissing cartilage defect within the knee. able to fully understand the process and study and give informed consent to participate. able to comply with the physiotherapy rehabilitation and follow up process. exclusion criteria: * kissing cartilage defects. defects deemed too large to undergo microfracture on mri scan. clinically unstable knee joint. patients unable to consent to participation. under 16 years of age or over 60 years of age. patients likely to drop out of physiotherapy rehabilitation and study follow up.
l-arginine concentrations and cps polymorphisms in vlbw infants

Conditions: Infant, Very Low Birth Weight

Summary: plasma l-arginine concentrations are decreased in premature infants with necrotizing enterocolitis (nec). a carbamoyl-phosphate synthetase 1 (cps1) polymorphism has been correlated with low plasma concentrations of l-arginine in neonates (\> 35 weeks of gestation). recently moonen et al (pediatr res 2007; 62(2):188-90) described a correlation between this cps1 t1405n single nucleotide polymorphism (snp) and the presence of nec in vlbw infants. however there is no data about the correlation between the plasma arginine concentrations and the t1405n snp in the cps-1 gene in vlbw infants. in the present project we postulate that t1405n snp in the cps-1 gene is associated with lower plasma arginine concentrations and is also a risk factor for the development of nec.

plasma l-arginine concentrations are decreased in premature infants with necrotizing enterocolitis (nec). a c-to-a nucleotide transversion (t1405n) in the gene that encodes carbamoyl-phosphate synthetase 1 (cps1), the rate-limiting enzyme in the urea cycle, has been correlated with low plasma concentrations of l-arginine in neonates (\> 35 weeks of gestation). recently moonen et al (pediatr res 2007; 62(2):188-90) described a correlation between this cps1 t1405n single nucleotide polymorphism (snp) and the presence of nec in vlbw infants. however there is no data about the correlation between the plasma arginine concentrations and the t1405n snp in the cps-1 gene in vlbw infants. in the present project we postulate that t1405n snp in the cps-1 gene is associated with lower plasma arginine concentrations and is also a risk factor for the development of nec.

Eligibility criteria:
inclusion criteria: * vlbw infants (\< 30 weeks and \< 1500 gram birth weight). exclusion criteria: * blood transfusion, enteral or parenteral protein intake, or inhaled nitric oxide administration before time of the blood sample (obtained between 6 and 12 hours after birth). * parents not able to give informed consent.
qigong exercise may benefit patients with fibromyalgia

Conditions: Fibromyalgia

Summary: the long-term goal of our research program is to develop an effective and cost-saving mind-body therapy to help patients with fm. the objective of this pilot study is to gather pilot data of the effect on pain, fatigue, sleep quality, and quality of life in fm patients using a specific type of qigong exercise, i.e. "six healing sound" qigong. changes in relevant brain activity will be monitored in study subjects before and after the qigong exercise program, which may help us in better understanding the underlying mechanism of the qigong exercise. data collected in this pilot study will help the investigators in preparation for a future clinical trial with a larger sample size. our central hypothesis for the future clinical trial is that qigong exercise will lead to a significantly greater improvement in pain, fatigue, sleep quality, and quality of life in the experimental group compared to the control group.


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of primary fm, based on the 1990 american college of rheumatology criteria (wolfe et al, 1990), * between the ages of 18 and 70 years; * willing to withdraw from cns-active therapies commonly used to treat fm; willing to discontinue treatment with transcutaneous electrical nerve stimulation, biofeedback, tender- and trigger-point injections, acupuncture, and anesthetic or narcotic patches; * with a raw score \> 4 on the physical function component of the fibromyalgia impact questionnaire (fiq) (burckhardt et al, 1991); * and a mean visual analog scale (vas) pain score \> 40 on a scale from 0 to 100. exclusion criteria: * severe psychiatric illness; * a current major depressive episode (as determined by a beck depression inventory (beck et al, 1961) score \>25); * significant suicide risk; * abuse of alcohol, benzodiazepines, or other drugs; a history of behavior that would prohibit compliance for the duration of the study; * active cardiovascular, pulmonary, hepatic, renal, gastrointestinal, or autoimmune disease (except hashimoto's or graves' disease that had been stable for 3 months before screening); * current systemic infection; active cancer (except basal cell carcinoma); unstable endocrine disease; severe sleep apnea; * prostate enlargement or other genitourinary disorder (male patients); * or pregnancy or breastfeeding (female patients).
phase ii trial to evaluate laparoscopic surgery for stage 0/i rectal carcinoma

Conditions: Rectal Cancer

Summary: the purpose of this study is to examine the technical and oncological feasibility of laparoscopic surgery for rectal carcinoma

recently reported randomized controlled trials demonstrated that laparoscopic surgery was comparable or superior to open surgery regarding the long-term outcome for colon and rectosigmoidal carcinoma; however, controversy persists regarding the appropriateness of laparoscopic surgery for patients with rectal carcinoma because of the uncertainty of the long-term outcome, and of concerns over the safety of the procedure. in japan, lateral lymph node dissection combined with total mesorectal excision remains the standard surgical procedure for patients with advanced lower rectal carcinoma, and lateral lymph node dissection by laparoscopy is still an unexplored frontier. to examine the technical and oncological feasibility of laparoscopic surgery for rectal carcinoma, a phase ii trial will be conducted in patients with a preoperative diagnosis of stage 0/i rectal carcinoma, under the direction of the japan society of laparoscopic colorectal surgery, to which leading hospitals in laparoscopic surgery for colorectal carcinoma in japan are members.

Eligibility criteria:
inclusion criteria: 1. histologically proven rectal carcinoma. 2. tumor located in the rectum. 3. clinical tis, t1, t2 n0 m0 4. without multiple lesions other than carcinoma in situ 5. tumor size \<8 cm. 6. sufficient organ function. 7. no bowel obstruction. 8. no history of major colorectal surgery. 9. no history of chemotherapy or radiotherapy. 10. provide written informed consent. exclusion criteria: 1. synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ. 2. pregnant or lactating women. 3. severe mental disease. 4. severe pulmonary emphysema, interstitial pneumonitis or ischemic heart disease. 5. continuous systemic steroid therapy.

Keywords: laparoscopic surgery, rectal carcinoma, phase ii trial
effect of curcumin on lung inflammation

Conditions: Chronic Obstructive Pulmonary Disease

Summary: chronic obstructive pulmonary disease (copd) and lung cancer are leading causes of death and health care use. diffuse airways inflammation is seen in copd and is thought to be the reason for deterioration of lung function in copd. currently there is no medication available that can modify or reduce this inflammation. furthermore, from literature review it has been shown that chronic inflammation can result in cancerous changes. curcumin is a food additive used for centuries. several studies showed that curcumin suppress the different inflammatory pathways. specially, the tnf-alpha and the nf kappa-b are down regulated by this substance. this study was designed to evaluate effect of combination of curcumin+bioprine on sputum cytology in patients with copd. this is double-blind randomized pilot study.


Eligibility criteria:
inclusion criteria: * age equal or more than 45 with moderate copd: fev1/fvc ratio less than 70 percent; post bronchodilator fev1 less than 50 percent * 20 pack year cigarette smoking * stable clinical course (symptoms/ medications) for 8 weeks * fixed address/not planning to leave * being able to perform spirometry * able to understand and consent exclusion criteria: * other chronic respiratory diseases such as asthma, interstitial fibrosis, sarcoidosis * heart failure nyh iii \& iv; symptomatic liver or renal failure * dementia or other neurocognitive deficit preventing completion of symptom diary * use of inhaled or systemic corticosteroids within 8 weeks of enrollment in the study

Keywords: proven diagnosis copd sputum
a phase iii study of bms-512148 (dapagliflozin) in asian patients with type 2 diabetes who are not well controlled on metformin alone

Conditions: Type 2 Diabetes

Summary: the purpose of this clinical research study is to learn if bms-512148 (dapagliflozin) can help reduce the blood sugar levels in asian patients with type 2 diabetes who are not well controlled on metformin alone. the safety of this treatment will also be studied.


Eligibility criteria:
inclusion criteria: * males and females, 18 to 77 years old, with type 2 diabetes and with inadequate glycemic control * drug naive or treated with anti-diabetic medication for \< 24 weeks * c-peptide ≥ 1.0 ng/ml * body mass index ≤ 45.0 kg/m² exclusion criteria: * ast and/or alt \> 3 times uln * serum total bilirubin \> 2 mg/dl * serum creatinine ≥ 1.50 mg/dl for men or ≥ 1.40 mg/dl for women * creatine kinase ≥ 3 times uln * symptoms of severely uncontrolled diabetes * currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
metabolic syndrome feasibility study

Conditions: Metabolic Syndrome

Summary: the objective of this study is to determine whether the finger tip images captured by the epic clearview device, when analyzed via the clearview software, produce a response scale that characterizes trends consistent with metabolic syndrome identified by medical doctors.


Eligibility criteria:
metabolic group inclusion criteria: 1. sex: male or female 2. age range: 21 to 85 3. qualifying metabolic syndrome diagnosis(using the national cholesterol education program adult treatment panel (atp) iii definition)(grundy, 2004) subjects will be identified as having metabolic syndrome if they meet at least three of the following five criteria: * elevated waist circumference: ≥ 102 cm (≥40 inches) in men, ≥ 88 cm (≥35 inches) in women * elevated triglycerides: ≥ 150 mg/dl (1.7 mmol/l) or on drug treatment for elevated triglycerides (examples include, but are not limited to, fibrates and nicotinic acid) * reduced hdl cholesterol: \< 40 mg/dl (1.03 mmol/l) in men or \< 50 mg/dl (1.3 mmol/l) in women or on drug treatment for reduced hdl-c * elevated blood pressure: ≥ 130 mm hg systolic blood pressure or ≥85 mm hg diastolic blood pressure or on antihypertensive drug treatment in a patient with a history of hypertension * elevated fasting glucose: ≥ 100 mg/dl or on drug treatment for elevated glucose 4. the patient or legal representative is able to understand and provide signed consent for the procedure. exclusion criteria: 1. patients \ 85 years in age. 2. inability or unwillingness to provide informed consent. 3. patients with pacemakers or another electrical device implanted somewhere in their body. 4. pregnant women. 5. missing all or part of fingers or cuts/burns on pads of fingers 6. hand tremors or involuntary oscillations of the hands that prevents clear imaging control group: inclusion criteria: 1. sex: male or female 2. age range: 21 to 85 3. freedom from qualifying medical diagnoses (control group) any one of the following will exclude the subject from participation in the study 1. documented current diagnosis/treatment of cancer (including sickle cell disease) 2. documented current diagnosis/treatment of coronary artery disease or heart attack 3. documented as currently in renal failure (chronic or acute) or on renal dialysis 4. documented current diagnosis/treatment for hepatitis 5 .the patient or legal representative is able to understand and provide signed consent for the procedure. exclusion criteria: 1. patients \ 85 years in age. 2. bility or unwillingness to provide informed consent. 3. patients with pacemakers or another electrical device implanted somewhere in their body. 4. pregnant women. 5. missing all or part of fingers or cuts/burns on pads of fingers 6. hand tremors or involuntary oscillations of the hands that prevents clear imaging
covid-19 patients characterization, biobank, treatment response and outcome predictor

Conditions: Coronavirus Infections

Summary: collection and analysis of demographic, clinical, radiographic and laboratory characteristics of covid-19 patients to identify predictors of disease severity, mortality and treatment response, and to identify subgroup of patients that might benefit from specific therapeutic interventions


Eligibility criteria:
inclusion criteria: * patients admitted to hospital with biological samples positive for sars-cov-2 * patients admitted to hospital with negative test but clinical and radiological characteristics highly suggestive of sars-cov-2 disease * patients discharged from emergency department with biological samples positive for sars-cov-2 exclusion criteria: * none
accuracy of spircare device as compared to the conventional plethysmograph

Conditions: COPD Asthma; Pulmonary Fibrosis

Summary: the purpose of this study is to assess the accuracy of frc and airway resistance calculate values of spircare device as compared to the conventional body plethysmograph in healthy adults and patients with obstructive and restrictive pulmonary diseases/disorders.


Eligibility criteria:
inclusion criteria: 1. signed informed consent. 2. age≥18 year. 3. subject is cooperative and capable of following instructions. 4. phase i: healthy asymptomatic subjects, never smokers without known history of respiratory, cardiovascular, hepatic, renal or metabolic disease. 5. phase ii: chronic pulmonary patients with lung volume disorders: * copd * asthma * restrictive diseases such as pulmonary fibrosis, other interstitial lung diseases, kyphoscoliosis, neuro-muscular disorders. exclusion criteria: 1. subjects unable or unwilling to give informed consent. 2. subjects who are unable to satisfactorily perform routine, full lung function testing (due to non-compliance or claustrophobia). 3. history suggesting upper respiratory infection during the four weeks prior to testing 4. physical activity during 1 hour prior to the study. 5. patients with a tracheostomy. 6. pregnant women.
perception, cognition, and gait in parkinson's disease

Conditions: Parkinson Disease

Summary: the investigators are examining how aspects of daily function are perceived in persons with pd and in those who interact with them on a regular basis. if eligible, participants will receive a set of online questionnaires by email. the questionnaires will take about 1 hour to complete, and can be done at the participant's convenience. the investigators are looking for volunteers who have a diagnosis of parkinson's disease without dementia (age 40 or older and proficient english speakers). if a spouse, family member, significant other or other close associate is available (age 18 or older, proficient english speakers), the investigators will send them questionnaires as well. there is no monetary or other compensation for this study. for more information, please contact the vision and cognition laboratory at vcognition@gmail.com or 617-358-1377.


Eligibility criteria:
inclusion criteria: * diagnosed with parkinson's disease without dementia or close associate of someone with parkinson's disease * 40 years or older * proficient english speaker * access to a computer * 8+ years of education exclusion criteria: * co-existing active neoplasm, serious cardiac disease, other serious chronic medical illness * prior intracranial surgery * history of traumatic brain injury * psychiatric or neurological diagnoses other than parkinson's disease * history of alcoholism or other drug abuse * history of treatment with electroshock therapy

Keywords: parkinson's disease online study quality of life activities of daily living perception cognition gait
validation of the french translation of a self-questionnaire looking for a history of pre-eclampsia.

Conditions: Preeclampsia

Summary: preretro is a study for validation of the french translation of a self-questionnaire looking for a history of pre-eclampsia of more than 5 years in women who have already had a pregnancy of more than 6 months with childbirth at brest university hospital.

this study will help to evaluate the specificity and sensitivity of the french translation of a self-questionnaire looking for a history of pre-eclampsia in women who gave birth at brest university hospital before year 2015. first, women with pre-eclampsia (cases) and women with no hypertensive disorders (controls) during pregnancy were identified with the medical registry database (mrd) of brest university maternity ward. all pre-eclampsia diagnoses were reviewed by 2 experts in order to confirm the accuracy of the diagnosis. 250 cases and 250 controls were finally selected after consultation of their medical file and were pre-included in the study. then, the 500 women will be contacted by phone or e-mail in order to inform them about the study and to offer them the possibility to participate in the study. the women who will agree to participate in the study will fill in an online self-questionnaire on pre-eclampsia. their responses will then be compared to the diagnosis retained after consultation of their medical file. sensitivity and specificity of the questionnaire will then be evaluated.

Eligibility criteria:
inclusion criteria: * women who gave birth after a pregnancy of more than 6 months at brest university hospital between january 2002 and december 2014 * for the cases: with a pre-eclampsia diagnosis during pregnancy * for the controls: with no history of hypertensive disorder during pregnancy exclusion criteria: * women under legal protection * women unable to read french * medical interruption of pregnancy * pregnancy with a delivery before 6 months * women who refused to participate in the study

Keywords: questionnaire