Kornimate/medical-research-clean huggingface dataset:
partners in health: a couples-based approach to obesity prevention

Conditions: Obesity

Summary: the purpose of this pilot study is to test the feasibility of an innovative, couples based approach to weight management during pregnancy. the primary hypothesis is that a couples-based behavioral weight management program will reduce the rate of gestational weight gain compared to standard care.


Eligibility criteria:
inclusion criteria: pregnant women * \>18 years old * 15-22 weeks gestation * bmi \>= 25 * cohabitating with partner for at least 3 months or recently married * willing to consent non-pregnant partner * bmi \>= 25 * cohabitating with partner for at least 3 months or recently married * willing to consent exclusion criteria: * untreated medical or psychological problem * inability to be physically active

Keywords: overweight obese pregnancy weight gain weight loss
internet based screening and stepped care for cancer patients with anxiety and depression symptoms

Conditions: Cancer; Anxiety; Depression

Summary: the aim is to evaluate the effects of internet based stepped care on anxiety, depression and health related quality of life in cancer patients with anxiety and depression symptoms, compared to standard care, and to evaluate the health-economic effects of the intervention. the investigators also want to examine the development of anxiety and depression symptoms and health related quality of life in cancer patients without initial symptoms. the primary hypothesis is that internet based stepped care (i-sc) is more effective in relieving anxiety and depression symptoms in cancer patients, compared to standard care (sc). secondary hypotheses are that less anxiety and depression symptoms also means improved health related quality of life and that i sc is cost-effective or at least cost neutral compared to standard care. the it-platform carebase.se is developed within u-care. the platform will be used for delivering of interventions and for collection of all patient reported outcomes. patients with anxiety or depression symptoms according to the hospital anxiety and depression scale will be randomized to i sc or sc. patients with no initial anxiety or depression symptoms will be included in descriptive studies. all patients, in the randomized controlled trial and the descriptive study will followed up during 24 months i-sc comprises interactive support (step 1) and cognitive behavioral therapy (cbt; step 2). step 1 starts directly after randomization and extends over a 24 months period. step one comprises web-based patient education including psycho-education and easy interventions strategies employed in cbt. step 1 also includes a faq, a discussion board for patients and a personal diary. project staff (nurses) is responsible for the faq and to moderate the discussion board. the nurses will be supervised by a cbt psychologist. they can also turn to other experts in the project group for advices about how to answer patients' questions. patients with remaining anxiety or depression symptoms at 1, 4 or 7 months after randomization will be offered step 2. step 2 comprise conventional internet based cbt for common psychological concerns. the participants' chooses to work with modules that correspond to prioritized concerns, e.g. anxiety or depression. the cbt is structured and manualized and include conventional treatment methods with homework and weekly contacts with the psychologist. step 2 extends over a 10-week period.


Eligibility criteria:
inclusion criteria: * newly diagnosed breast- colorectal- or prostate cancer or recurrent colorectal cancer within 3 months form diagnoses exclusion criteria: * inability to communicate in swedish * karnovsky performance status \< 40 * short expected survival (\< 6 month) * cognitive disability (e.g. dementia or psychosis) * severe depression or suicide risk
a phase 3 study to evaluate the efficacy and safety of k-877 in chinese patients with high tg and low hdl-c

Conditions: Hyperlipidemia

Summary: a phase 3 study to evaluate the efficacy and safety of k-877 in chinese patients with high tg and low hdl-c


Eligibility criteria:
inclusion criteria: subjects are eligible to be included in the study only if all of the following criteria apply: 1. ability to understand and comply with study procedures and give written informed consent 2. following the diet and lifestyle recommendations at least 12 weeks prior to the treatment period 3. males or post-menopausal females 4. aged ≥18 years at the time of informed consent 5. fasting serum tg levels ≥200 mg/dl (≥2.26 mmol/l) and ≤500 mg/dl (5.65 mmol/l) at screening 6. serum hdl-c \<50 mg/dl (\<1.30 mmol/l) if male or \<55 mg/dl (\<1.42 mmol/l) if female at screening. exclusion criteria: subjects are excluded from the study if any of the following criteria apply: 1. current or planned use of any lipid-altering medications other than the study drugs, statins, or ezetimibe during the study. i. subjects currently on statins or ezetimibe must be at high risk for atherosclerotic cv diseases, and the dose(s) must be stable for at least 4 weeks prior to screening ii. for subjects currently on lipid-altering medications other than statins or ezetimibe, at least 4-week washout period (or for subjects currently on probucol at least 8 week washout period) will be required prior to the first fasting blood sampling at screening visit 2. type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus defined by hba1c (ngsp level) ≥8.0% at screening 3. uncontrolled hypertension defined by seated systolic blood pressure ≥160 mmhg and/or diastolic blood pressure ≥100 mmhg at screening 4. uncontrolled thyroid disorder 5. creatinine ≥1.5 mg/dl at screening 6. severe hepatic disorder defined as cirrhosis of child-pugh class b or c, or ast or alt \>2 × uln at screening 7. history of pancreatitis 8. gallbladder disorder, history of cholelithiasis, primary biliary cirrhosis, or history of disease or surgery that may affect the absorption, distribution, metabolism and excretion of drugs or the metabolism of bile salts 9. unexplained creatine kinase (ck) \>5 × uln at screening 10. myocardial infraction or stroke (including transient ischemic attack) within 3 months prior to the informed consent 11. new york heart association class iii or iv heart failure 12. history of malignancy within 5 years 13. participation in another clinical study at the time of informed consent or administration of an investigational drug other than placebo within 16 weeks prior to the informed consent for this study
short clinical outcome of microscope assisted discectomy: results of 90 cases in iraq

Conditions: To Evaluate the Effectiveness if Microscope in Discectomy

Summary: a total of (90) patients involved in this study a randomized sampling use. the adult patient between (17) and (50) years of age complaining of lower back pain; and or radiculopathy and neurological symptoms, whom failed to respond to a (6-8) weeks period of conservative therapy (life style modification, nsaids, and physiotherapy). they are operated by microscopic assisted discectomy and were followed by odi and vas for back pain and leg pain for 4 months after surgery

a total of (90) patients involved in this study a randomized sampling use. the adult patient between (17) and (50) years of age complaining of lower back pain; and or radiculopathy and neurological symptoms, whom failed to respond to a (6-8) weeks period of conservative therapy (life style modification, nsaids, and physiotherapy). the diagnosis carried out using history, physical examination, mri done for the patient to confirm the diagnosis and the level of disc herniation and know the direction and extend of disc herniation.population excluded from study were the age group above or less the ones whom involved in the study, any other type of disc herniation apart from l3-l4, l4-l5, l5-s1, multilevel pathology, patients with spondylolisthesis, spondylolysis, patients with scoliosis and kyphosis, patients with cauda equina syndrome, patients with previous back surgery, and with no local infection.all the patients discharged on the same day of operation or a day after, mobilized soon as they were ready. patient were reviewed in intervals of (2) weeks (2) months and (4) months after surgery using vas for low back pain and leg pain and oswestry disability index.

Eligibility criteria:
inclusion criteria: * lower back pain; and or radiculopathy and neurological symptoms, whom failed to respond to a (6-8) weeks period of conservative therapy (life style modification, nsaids, and physiotherapy). exclusion criteria: * population excluded from study were the age group above or less the ones whom involved in the study, any other type of disc herniation apart from l3-l4, l4-l5, l5-s1, multilevel pathology, patients with spondylolisthesis, spondylolysis, patients with scoliosis and kyphosis, patients with cauda equina syndrome, patients with previous back surgery, and with no local infection.

Keywords: short-term clinical outcome microscopic assisted discectomy lumbar disc herniation
flash [fluorescent light activated synthetic hypericin] clinical study: topical sgx301 (synthetic hypericin) for the treatment of cutaneous t-cell lymphoma (mycosis fungoides)

Conditions: Cutaneous T-Cell Lymphoma

Summary: to evaluate the use of sgx301, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous t-cell lymphoma (mycosis fungoides).


Eligibility criteria:
inclusion criteria: * subjects must have a clinical diagnosis of ctcl (mycosis fungoides), stage ia, stage ib, or stage iia. * subjects must have a minimum of three (3) evaluable, discrete lesions. * subjects must be willing to refrain from sunbathing for the duration of the study. exclusion criteria: * history of sun hypersensitivity and photosensitive dermatoses including porphyria, systemic lupus erythematosus, sjögren's syndrome, xeroderma pigmentosum, polymorphous light eruptions or radiation therapy within 30 days of enrolling. * pregnancy or mothers who are breast feeding. * males and females not willing to use effective contraception. * unhealed sunburn. * subjects receiving topical steroids or other topical treatments for ctcl within 2 weeks. * subjects receiving systemic steroids, nitrogen mustard, psoralen uva radiation therapy (puva), narrow band uvb light therapy (nb-uvb) or carmustine (bcnu) or other systemic therapies for ctcl within 3 weeks of enrollment. * subjects with significant history of systemic immunosuppression due to drugs or infection with hiv or htlv 1. * subjects taking other investigational drugs or drugs of abuse within 30 days of entry into this study.

Keywords: ctcl mycosis fungoides hypericin sgx301 mf
study about the evolution of severe late onset pompe disease patient with pulmonary dysfunction and receiving myozyme®

Conditions: Pompe Disease (Late-Onset); Glycogen Storage Disease Type II (GSD II); Glycogenesis 2 Acid Maltase Deficiency

Summary: to describe severe late onset patients with pompe disease receiving myozyme®


Eligibility criteria:
inclusion criteria: * male or female ≥ 18 years of age; * the patient and/or patient's legal representative has given their informed consent in writing before any study procedure is initiated; * pompe disease confirmed by documented deficit in endogenous acid alpha-glucosidase (gaa) activity; * a severe form of the disease as defined as follows: a. moderate to severe limb girdle muscle weakness requiring help for walking around (sticks, crutches, walking frame or wheelchair); and b. symptoms of diaphragmatic dysfunction defined by at least 2 out of the 3 following criteria: orthopnea, vital capacity \< 50%, paradoxical respiration detected in measurement of transdiaphragmatic pressure; and c. use of invasive ventilation (defined by need for tracheotomy) or noninvasive ventilation (defined by utilization of assisted ventilation using a nasal or facial mask)day and night prescribed ≥ 12 hours/day; * treated for ≥6 months with myozyme; * followed-up in a reference center according to the cetp recommendations. exclusion criteria: * the patient presents with a major congenital anomaly; * the patient presents with a clinically important organic disease (except for symptoms related to pompe disease) such as cardiovascular, hepatic, pulmonary, neurological or renal disease or any other medical condition, serious disease or particular circumstances that in the investigator's opinion, should preclude the patient's participation.
pet with [18f]hx4 in head and neck cancer

Conditions: Cancer of the Head and Neck

Summary: the aim of this study is to (i) determine if tumor hypoxia can be accurately visualised with \[18f\] hx4 pet imaging in head and neck tumors (ii) correlate the \[18f\] hx4 pet images with blood and tissue markers and (iii) investigate the quality and optimal timing of \[18f\] hx4 pet imaging (iv) compare \[18f\] hx4 pet uptake with \[18f\] fdg pet uptake before and after treatment.

tumor hypoxia is the situation where tumor cells are or have been deprived of oxygen. hypoxic tumor cells are usually more resistant to radiotherapy and chemotherapy and more likely to develop metastasis. in head and neck cancer, tumor hypoxia is known to be an important prognostic factor for long term survival. \[18f\]hx4 is being developed as a diagnostic radiopharmaceutical for pet imaging to find a marker for hypoxia that can be used in standard clinical practice. current hypoxia tracers lack reliable image quality and kinetics. because of the short half life and clearance, we expect that \[18f\]hx4 will have a higher tumor to background ratio than current nitro-imidazole hypoxia markers such as \[18f\]-misonidazole. the clinical use of a reliable, non-invasive and easy to use hypoxia imaging agent could allow selection of patients most likely to benefit from hypoxia modifying therapies. included are eligible patients with head and neck squamous cell carcinoma (t2, t3, t4, any n, m0) with tumor diameter ≥ 2,5 cm of the oral cavity, oropharynx, hypopharynx or larynx, planned to be treated with curative primary radiation treatment (+/- concurrent chemotherapy). before treatment a standard planning \[18f\]fdg pet-ct will be performed, a blood sample is drawn and baseline \[18f\]hx4 pet scans will be performed. 18f-hx4 scans will be repeated after radiotherapy treatment with 20 +/- 4 gy (approximately two weeks). three months after the end of treatment a \[18f\]fdg pet scan will be performed.

Eligibility criteria:
inclusion criteria: * histological or cytological confirmed hnssc of the oral cavity, oropharynx, hypopharynx, larynx, t2-t3-t4, any n, m0 * tumor diameter ≥ 2,5 cm * who performance status 0 to 2 * scheduled for primary curative (concurrent chemo-) radiotherapy * no previous surgery to the head and neck * no previous radiation to the head and neck * adequate renal function (calculated creatinine clearance at least 60 ml/min). * the patient is willing and capable to comply with study procedures * 18 years or older * have given written informed consent before patient registration exclusion criteria: * no recent (\< 3 months) myocardial infarction * no uncontrolled infectious disease * not pregnant or breast feeding and willing to take adequate contraceptive measures during the study

Keywords: cancer of the head and neck [18f]hx4 hypoxia pet phase ii trial
the importance of glp-1 in post rygb improvement in glycaemic control type 2 diabetic subjects

Conditions: Type 2 Diabetes

Summary: after roux-en-y gastric bypass (rygb) meal induced glp-1 secretion is dramatically increased, while beta-cell function is increased in type 2 diabetic (t2d) subjects. the aim of this study is to establish causality between the two observations. by meal testing 10 t2d subjects with infusion of saline or exendin (9-39), a glp-1r specific blocker, before and 1 week and 3 months after rygb we hope to demonstrate the role of glp-1 in improveing beta-cell function and maintaing glucose tolerance after rygb in t2d subjects. furthermore, effects of glp-1 rec blockade before and after rygb on ad libitum energy intake is examined

after roux-en-y gastric bypass (rygb) meal induced glp-1 secretion is dramatically increased, while beta-cell function is increased in type 2 diabetic (t2d) subjects. the aim of this study is to establish causality between the two observations. by meal testing 10 t2d subjects with infusion of saline or exendin (9-39), a glp-1r specific blocker, before and 1 week and 3 months after rygb we hope to demonstrate the role of glp-1 in improveing beta-cell function and maintaing glucose tolerance after rygb in t2d subjects. furthermore, effects of glp-1 rec blockade before and after rygb on ad libitum energy intake is examined

Eligibility criteria:
inclusion criteria: * fasting glucose \> 7.0 mm, 2h glucose after ogtt \> 11.0 mm. bmi \> 35. hba1c \ 700 pm. elegible for rygb. exclusion criteria: * dysregulated hypothyroidism, hyperthyroidism, anaemia.

Keywords: rygb bariatric surgery glucagon-like-peptide 1
prophylactic peripheral iridectomy prevents aphakic angle-closure glaucoma

Conditions: Congenital Cataract; Aphakic Glaucoma

Summary: this is a retrospective, nonrandomized comparative trial with historical control to investigate the safety and efficacy of a novel progressive grasping peripheral iridectomy (pgpi) surgical method in preventing aphakic angle-closure glaucoma (aacg) following congenital cataract surgery.

aphakic angle-closure glaucoma (aacg) following congenital cataract surgery is a common and serious complication which can be prevented by prophylactic peripheral iridectomy (ppi). however, it is difficult to perform routine ppi via scleral tunnel incision especially when the pupil is dilated. here, the investigators designed a novel progressive grasping peripheral iridectomy (pgpi) surgical method which can ensure the accurate iridectomy position and minimize the complication. the aim of this study is to assess the safety and efficacy of the pgpi in preventing aacg following congenital cataract surgery. this is a retrospective, nonrandomized comparative trial with historical control. the congenital cataract patients performed with cataract extraction combined with ppi (ppi group) and the patients performed with cataract extraction alone and leaving the iris intact (historical control group) were enrolled and a retrospective medical chart review was conducted. the iop, anterior chamber depth, corneal clarity, patency of peripheral iridectomy opening, and the rate of aacg, iris posterior synechia (ips) and visual axis opacity (vao) were compared between two groups.

Eligibility criteria:
inclusion criteria: 1. patients less than 2 years old; 2. patients performed with congenital cataract surgery with or without ppi; 3. patients with routine follow-up at zoc. exclusion criteria: 1. patients with iop ≥21 mm hg or with congenital glaucoma or with a family history of glaucoma; 2. patients with keratopathy, retinopathy, ocular trauma, radiation therapy or intraocular surgery; 3. patients associated with other congenital ocular anomalies, such as anterior segment dysgenesis, microcornea/microphthalmia, persistent fetal vasculature, lens dislocation and iridocoloboma; 4. patients with systemic diseases, such as down's syndrome, lowe syndrome, stickler syndrome, maternal rubella syndrome or trisomy 13.

Keywords: congenital cataract prophylactic peripheral iridectomy aphakic angle-closure glaucoma aphakic open-angle glaucoma iris posterior synechia visual axis opacity
systemic inflammation and obstructive sleep apnea syndrome: effect of atorvastatin

Conditions: Obstructive Sleep Apnea Syndrome

Summary: the aim of this clinical trial is to evaluate the effect of atorvastatin on the endothelial function improvement during the obstructive sleep apnea syndrome (osas) after 3 months of treatment, by a double-blind, randomized, placebo-controlled, multi-center study. an interim analysis will be performed when 25 patients per group will be included.

secondary objectives of this clinical trial : * to evaluate the effect of atorvastatin in comparison with the placebo on the inflammation occurring during osas, after 3 months of treatment. * to evaluate the effect of atorvastatin in comparison with the placebo on the insulin-resistance associated to osas, after 3 months of treatment. * to evaluate the effect of atorvastatin in comparison with the placebo on the hypercholesterolemia associated to osas, after 3 months of treatment. * to evaluate at 6 months, the effect of the continuous positive airway pressure (cpap) + atorvastatin association on the previously cited parameters, in comparison with atorvastatin, cpap and placebo. * to measure the cpap efficiency in comparison with sham cpap in patients receiving the placebo, after 3 months of treatment.

Eligibility criteria:
inclusion criteria: * men or women \> 18 years old * subjects diagnosed with osas (apnea/hypopnea index = ahi \> 30/h) * subjects with clinical ath from grade i or ii controlled with mono-therapy(140\<sap\<180 mmhg and 90\<dap\<110 mmhg) exclusion criteria: * patients with a history of prior stroke or coronary ischemic disease * chronic respiratory disease (pao2 \ 45 mmhg) * lung disease * hypothyroidism * statin treatment * antihypertensive treatment with more than one drug * pregnant or lactating women * alcohol consumption \> 3 units/day * treatment by itraconazole, ketoconazole, antiprotease, fibrates, antivitamin k, diltiazem, verapamil, erythromycin, clarithromycin, cyclosporin. * hypersensitivity to one of the drug compounds * patients with modified concomitant treatments during the 3 months before inclusion * potentially dangerous sleepiness * jobs at risk

Keywords: statins cardiovascular risk obstructive sleep apnea syndrome (osas) patients
effects of transcranial pulse stimulation in parkinson's disease

Conditions: Parkinson

Summary: the investigators are studying if transcranial pulse stimulation (tps) can improve various symptoms, including movement problems, thinking abilities, mood, fatigue, freezing while walking, voice quality, and issues with smell and taste. previous research suggests tps might help in alzheimer's disease and could be helpful for parkinson's as well. investigators will check if tps is safe, practical, and if it makes a noticeable difference in these symptoms compared to before the treatment.


Eligibility criteria:
inclusion criteria: 1. diagnosis of "probable" or "possible" pd, as defined by the current clinical criteria (52) or as confirmed by a co-investigator neurologist or confirmation via medical records or a letter from a patient's physician. 2. age from 40 to 90 years old. 3. disease stages 2 to 4 based on the updrs scale subdomain v (or hoehn and yahr scale). 4. taking stable medications for pd for at least 30 days. exclusion criteria: 1. features suggestive of other causes of parkinsonism/parkinson's-plus syndromes. 2. history of deep brain stimulation, brain ablation surgeries, or malignant mass brain lesions. 3. history of schizophrenia, bipolar illness, or alcohol/drug abuse within the past six months. 4. need for rapid clinical response due to conditions such as initiation, psychosis, or suicidality. 5. contraindications to transcranial brain stimulation (i.e., metal objects in the head, metal implanted brain medical devices, cortisone treatments within six weeks before the first stimulation session, cns thrombosis, etc). 6. unstable medical conditions (e.g., uncontrolled diabetes, uncompensated cardiac issues, heart failure, uncompensated pulmonary disease, or chronic obstructive pulmonary disease). 7. contraindications to mri according to mgb screening in the martinos-center (i.e., pacemaker, defibrillator or wires other than sternal wires, metallic foreign body in the eye, or drug infusion devices - if the models of these devices are not compatible with mri). 8. pregnancy. 9. epilepsy or disorders that significantly increase the likelihood of seizures, including: (i) severe traumatic brain injury; (ii) congenital birth defects leading to seizures; (iii) brain tumor; (iv) metabolic disorders associated with seizures; (v) intracranial or subarachnoid hemorrhage; and (vi) non-lacunar strokes. 10. bed- or wheelchair-bound patients.