Kornimate/medical-research-clean huggingface dataset:
pf-06372865 in subjects with photosensitive epilepsy

Conditions: Reflex Epilepsy, Photosensitive

Summary: pf-06372865 in subjects with photosensitive epilepsy


Eligibility criteria:
inclusion criteria: * a diagnosis and history of photoparoxysmal response on electroencephalogram (eeg) with or without a diagnosis of epilepsy for which subjects are taking up to 0 - 2 concomitant antiepileptic drugs. * subjects currently taking antiepileptic drug(s) to be on a stable dose for 4 weeks prior to screening visit. * a minimum average standardized photosensitive range (spr) across all screening timepoints of 4 in the most sensitive eye condition and a non-zero average in at least one other eye condition. exclusion criteria: * subjects with a history of status epilepticus. * subjects who have experienced a generalized tonic-clonic convulsion in the past 6 months, at the time of the initial screening visit.
microrna expression and function in cutaneous malignant melanoma

Conditions: Melanoma

Summary: spectrophotometric intracutaneous analysis (siascopy) is a new technique for imaging pigmented skin lesions and for diagnosing melanoma and non-melanoma skin cancer. the siascope is a portable system comprising of a laptop computer connected to a small handheld skin probe equipped with a light source. the skin lesion is interrogated with light of different wavelengths and the reflection spectra analysed by proprietary algorithms showing distribution, position and quantity of melanin, blood and collagen within the papillary dermis (the siagraphs). earlier studies generated promising results and documented \>80% specificity and sensitivity of siascopy for melanoma diagnosis. it has been suggested that this technique could be used for the initial screening and selection of pigmented lesion for excision. in this work we addressed the usefulness of siascopy for the clinical diagnosis of pigmented malignant melanoma in a prospective, blinded design.


Eligibility criteria:
inclusion criteria: * pigmented lesion exclusion criteria: * no pigmented lesion

Keywords: melanoma siascope pigmented skin lesions
a trial of neoadjuvant folfox6 with short course radiotherapy in patients with unresectable rectal cancer and liver metastasis

Conditions: Rectal Cancer

Summary: the purpose of this study is the increase of resection rate of primary cancer in rectal after short course radiotherapy without interrupt chemotherapy schedule during the period of chemotherapy. the subject should have the pathologically confirmed for unresectable (impossible to try total mesorectal excision) rectal cancer with liver metastasis. this trial contributes to save the time for decreasing primary tumor in rectal and metastasis cancer to whole body after short course radiotherapy.


Eligibility criteria:
inclusion criteria: * subject whom should have the pathologically confirmed for unresectable (impossible to try total mesorectal excision) rectal cancer with liver metastasis. * over 18 years * ecog 0-1 * proper organ function (hepatic transaminases : \ 100,000ul, anc \> 1,500/ul * more than one target lesion (standard by recist 1.0) * who should sign on the informed consent form before participate the trial. exclusion criteria: * metastasis in other organ except liver (no matter whether have resection or not) * chronic active hepatitis or cirrhosis * history of treatment for colorectal cancer * subject pregnant or breast feeding * uncontrolled disease (eg. infection, hypertension, heart failure, myocardial infarction within 6months) * have been used folfox as an adjuvant therapy * have had adjuvant therapy within 6months * uncontrolled peripheral nerve infection * alcoholic or drug addict * subject currently is enrolled in or ≤30 days from ending other clinical trial. * history of other type of cancer except resolved from skin cancer and cervical cancer.
canadian observational study evaluating the long-term impact of cystic fibrosis transmembrane conductance regulator (cftr) modulators on people with cf

Conditions: Cystic Fibrosis

Summary: this observational study intends to investigate health trends and data in cystic fibrosis patients all across canada that are receiving modulator treatment so researchers can determine if cftr treatments are effective over a long period of time and if so, which treatments work best for each individual. the study will collect clinical data from routine standard of care, patient reported outcomes via survey data and samples for a biobank.


Eligibility criteria:
inclusion criteria: * prescribed a cftr modulator therapy and planning to commence modulator therapy within 30 days or planning to switch modulator therapies within 30 days * participates in the canadian cystic fibrosis registry (ccfr) * informed consent by participant, or parent/legal guardian or assent exclusion criteria: * known contraindications to cftr modulator therapy

Keywords: trikafta cystic fibrosis cftr modulator therapy respiratory disease
comparison of two methods of parathyroidectomy for primary hyperparathyroidism

Conditions: Hyperparathyroidism

Summary: parathyroid glands are small endocrine glands that secrete a hormone which controls blood calcium levels. primary hyperparathyroidism (ph) is a common disorder whereby one or more of these glands may enlarge and overproduce their hormone. subsequently, the elevated blood calcium can cause many other symptoms and problems. the standard treatment is surgical removal of the gland(s) causing the disorder. the standard safe and effective operation has been the bilateral open parathyroid exploration (bope). a newer procedure using a radioactive compound that concentrates in the parathyroid glands allows a more limited operation to find and remove the causative gland \[minimally-invasive radioguided parathyroidectomy (mirp)\]. the radiation exposure is minimal and safe. although the operation may prove to be less expensive, it is not certain whether it is as effective or as safe as bope. this study serves to directly compare the costs, the effectiveness, and the safety associated with each type of operation. all patients (adolescents and older) with ph are candidates to participate. the participants will be randomly assigned to the mirp group or the bope group independently of patient or physician preferences. mirp patients will undergo a sestamibi nuclear medicine scan to attempt to localize the specific parathyroid gland causing the hyperparathyroidism and subsequently a limited operation under local anesthesia to remove the single gland. parathyroid hormone levels will be measured during the operation to ensure that the patient has been cured. if not, the standard bope procedure will be completed. the total cost of the care will be tracked for each group. careful testing for complications such as vocal cord dysfunction will be done. general health status and pain levels will be measured before and after each operation. patient satisfaction with the operation and care will also be assessed.


Eligibility criteria:
inclusion criteria: * elevated serum calcium concentration on at least 2 occasions; if the value is \<11.0 mg/dl, it must have been present for at least 6 months; if the serum albumin concentration is not normal, the ionized calcium level will be measured and must be elevated. * nephrolithiasis or documented bone mineral density less than 2.5 standard deviations below age matched means. * elevated or non-suppressed serum intact parathyroid hormone level

Keywords: radionuclide imaging surgery
type 1 multiple endocrine neoplasia cohort study

Conditions: Type 1-Multiple Endocrine Neoplasia Syndrome

Summary: type 1 - multiple endocrine neoplasia syndrome (men1,) is an autosomal dominant disorder secondary to men1 mutations that predisposes carriers to endocrine tumors. the men1 gene located on chromosome 11q13 encodes menin, a 610 amino acid protein expressed in all tissues tested. menin is a scaffold protein which interacts with a large number of intracellular molecules. men1 disease may display various clinical associations the tumors mainly develop from endocrine tissues and may arise from parathyroid glands, duodeno-pancreas, pituitary gland, adrenal glands, and at a lower frequency from the bronchi and thymus. the penetrance is very progressive but ultimately high during a lifespan. although the syndrome was discovered in 1903 by erdheim and properly documented in 1954 by wermer, it was only in the 1970s that the variety of clinical presentations was acknowledged and first attempts to codify treatments were made. most published studies deals with selected and small size populations. thus, many aspects of the natural history of men1 remains unknown as well as the optimal care of patients. in addition, although advances in genetics improved the diagnosis of men1, there are still clinical forms whose attachment to the syndrome is difficult: atypical, paucisymptomatic, forms the negative genetic diagnosis (10%). these clinical forms need to be clarified to ensure optimum support. this cohort relies on the groupe d'étude des tumeurs endocrines (gte) network for men1, created in february 1991, and brings together clinical centers in france and belgium (n=80) as well as the four genetics laboratories in charge of men1 diagnosis. it aims at improving the knowledge of the men1mainly in describing: * its evolution over time globally and according to the initial presentation, ( particularly accounting the risk of the occurrence of secondary men1 related or unrelated tumors, and death) * the genotype-phenotype correlations and heritability of the disease * the real life management of patients and its impact on cure and survival for each type of men1-related tumor * the impact of the nem on the patients' daily lives, their perception of the disease and their satisfaction with their care


Eligibility criteria:
patients with men1 according to the gubbio criteria : * patients with a men1 mutation and presenting at least one of the following symptomatic or silent lesions: phpt or pancreatic or duodenal endocrine tumor * pituitary tumor * adrenal tumor * th-net * br-net * and gastric enterochromaffin-like tumor (ecloma). * patients belonging to a known men1 family (at least one first-degree relative affected) and presenting at least one of the aforementioned lesions. * patients without positive genetic testing or a family background presenting at least two of the three major men1 lesions (phpt, pancreatic, or duodenal endocrine tumor, pituitary tumor).:
the effects of progressive muscle relaxation therapy in patients with schizophrenia

Conditions: Affective Disorders; Psychotic Disorder

Summary: this study applied a randomized parallel case-controlled design. the study purpose was to evaluate the effects of progressive muscle relaxation on anxiety, psychiatric symptoms and quality of life among patients with chronic schizophrenia compared with an active control.

background: anti-psychotic drugs are limited in their ability to improve psychiatric symptoms, quality of life, and anxiety status in patients with chronic schizophrenia. progressive muscle relaxation (pmr) can potentially reduce anxiety status and improve subjective welling in acute patients. it is an ideal rehabilitation intervention for patients with chronic schizophrenia. however, no study has investigated the effects of pmr on outcomes among patients with chronic schizophrenia. design: this study applied a randomized parallel case-controlled design. methods: hospital-based randomized control trial in taiwan. eighty subjects with chronic schizophrenia were recruited from a psychotic ward and randomized into pmr, or control groups. patients in the intervention group participated in progressive muscle relaxation for 12 weeks; while patients in the control group members received supportive treatment-as-usual (tau). all participants completed anxiety, psychotic syndromes and quality of life measures at baseline, 3-month, and 3-month follow-up.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of schizophrenia * without the risk of self-injury and violence * patients aged from 20-65 years old * had no alcohol and drug abuse * can use mandarin or taiwanese to communicate exclusion criteria: * patients with another psychiatric comorbidity * patients with musculoskeletal problems * patients who cannot sit last for 50 minutes * had received progressive muscle relaxation training within the last year * diagnosis of confirmed cardiovascular disease

Keywords: pmr, anxiety, psychotic syndrome, quality of life
partners demonstration project of prep and art

Conditions: HIV Infection

Summary: the purpose of this protocol is to determine user preferences for antiretroviral therapy (art) for hiv-1 infected partners and pre-exposure prophylaxis (prep) hiv-1 un-infected partners and to optimize targeted delivery and sustained use of these interventions.

an open-label, prospective cohort study of higher-risk hiv-1 serodiscordant couples in order to determine barriers and facilitators to uptake and sustained adherence to art for hiv-1 infected partners and daily oral prep for hiv-1 uninfected partners. the investigators developed a risk score tool to identify couples at highest risk for hiv-1 transmission. prep was offered as a 'bridge' to art in the partnership - i.e., until art initiation by the hiv-infected partner and for the first 6 months after art is started; art was recommended following national art guidelines. a subset (up to 80 couples per site) was invited to participate in qualitative in-depth interview and focus group discussions.

Eligibility criteria:
inclusion criteria: for couples * risk score defining higher hiv-1 risk (≥6) * sexually active (defined as having had vaginal intercourse at least 6 times in the previous three months) * willing to enter the study as a couple and intending to remain as a couple for the next 12 months * did not participate in the partners prep study for hiv-1 uninfected members of the couple (partner participants) * age ≥18 * able and willing to provide written informed consent * hiv-1 uninfected based on negative hiv-1 rapid tests, both at study screening and at the enrollment visit * adequate renal function, defined by normal creatinine levels and estimated creatinine clearance \>60 ml/min * not infected with hepatitis b virus, as determined by a negative hepatitis b surface antigen test * not currently pregnant or breastfeeding * not currently enrolled in an hiv-1 prevention clinical trial * not currently using prep * enrollment of individuals with active and serious infections or active clinically significant medical problems will be at the discretion of the site investigator for hiv-1 infected members of the couple (index participants) * age ≥18 * able and willing to provide written informed consent * hiv-1 infected based on positive rapid hiv-1 tests, according to national algorithm * no history of who stage iii or iv conditions * not currently using art * not currently enrolled in an hiv-1 treatment study * note: current pregnancy and breastfeeding are permitted for hiv-1 infected partners exclusion criteria: * otherwise not eligible based on the above inclusion criteria

Keywords: tenofovir disoproxil emtricitabine pre-exposure prophylaxis antiretroviral therapy hiv prevention ftc tdf prep hiv infected partners hiv uninfected partners
buccal versus vaginal misoprostol in surgical termination of the first trimester missed abortion in erbil

Conditions: Missed Abortion

Summary: the purpose of this study is to determine the effectiveness of buccal misoprostol and comparing this with vaginal route of the same drug.


Eligibility criteria:
inclusion criteria: * first trimester missed abortion exclusion criteria: * history or evidence of disorders that represent contraindication to the use of misoprostol: * severe pulmonary diseases * congenital or acquired heart diseases * glaucoma * prolonged use of corticosteroid * sickle cell anemia and adrenal insufficiency * smokers * known hypersensitivity to drugs * any evidence of infection * patient's refusal to participate in the study * patients with abnormal results of investigations * patients with previous operations on cervix like conisation, cauterization, previous dilatation and curettage * patients with complete abortion * patients with severe bleeding that required emergency surgical evacuation of the uterus * patients with partially dissolved tablets at the site of application in both groups

Keywords: first trimester missed abortion misoprostol buccal vaginal cervical ripening first trimester missed abortion
cognitive - behavioral therapy

Conditions: Schizoaffective Disorder; Schizophrenia

Summary: the purpose of this study is to determine if cognitive - behavioral social skills training (cbsst) improves functioning in older patients with schizophrenia.

this is a randomized-control clinical trial. after completion the baseline assessment, subjects will be randomly assigned to either standard pharmacotherapy or sp+cbsst and will be followed for 18 months. the subjects will be 180 outpatients over the age of 45 with a diagnosis of schizophrenia or schizoaffective disorder.

Eligibility criteria:
inclusion criteria: patients must be 45 years of age or older with a diagnosis of schizophrenia or schizoaffective disorder. exclusion criteria:

Keywords: aging neuropsychology psychotherapy rehabilitation schizophrenia
study of three different stomach acid reducing agents when given with palbociclib (pd-0332991) and food

Conditions: Healthy

Summary: to investigate the effect of acid reducing agents (an antacid and an h2-receptor antagonist and a proton pump inhibitor) on palbociclib bioavailability in the presence of food.


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive. * body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). * willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures. exclusion criteria: * evidence or history of clinically significant diseases (hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease). * use of tobacco or nicotine containing products within 3 months of screening. * a positive urine drug screen.

Keywords: bioavailability antacid rabeprazole famotidine palbociclib
comparison of preoperative screening score for obstructive sleep apnea (osa)

Conditions: Sleep Apnea, Obstructive

Summary: comparison of preoperative screening score for osa. in a preoperative population, comparison of the stop-bang, des-osa, p-sap and osa50 score.

comparison of preoperative screening score for osa (obstructive sleep apnea). in a preoperative population, comparison of the stop-bang, des-osa, p-sap and osa50 score. comparison between scores and if applied with the results of a polysomnography (psg).

Eligibility criteria:
inclusion criteria: * all adults patients (\> 18 years) performing a preoperative assessment at the astes doctor's office (astes is an acronym with the name of medical doctors involved in this office) exclusion criteria: * patients \< 18 years
prometra post-approval study

Conditions: Chronic Pain; Cancer Pain; Intractable Pain; Back Pain

Summary: the prometra pump is approved by the fda for use in the united states. the purpose of this study is to collect long-term safety data on the prometra pump.

this study is proposed under part of the post-premarket approval (pma) requirements. this study is a prospective, non-randomized, open-label, multicenter study. it will be performed at 10-30 centers in the us and enroll a maximum of 400 subjects. subjects will be followed for a total of five years.

Eligibility criteria:
inclusion criteria: 1. patient meets at least one of the following: * is suffering from malignant pain (i.e., cancer pain) * has chronic, non-malignant pain * subject was enrolled in pump i or pump ii study and chooses to participate in this post-approval study * patient with an existing implantable pump for pain therapy that requires replacement 2. patient is at least 22 years of age. 3. investigator considers the patient to be able and willing to fulfill all study requirements. 4. patient has provided written informed consent to participate in the study. exclusion criteria: 1. patient meets any of the contraindications for use of the prometra system 2. patient has a prior history of granuloma formation, or is receiving treatment for a suspected granuloma. 3. patient is pregnant or breast-feeding or is of child-bearing potential and not employing effective birth control.

Keywords: morphine implantable infusion pumps intrathecal pump
dexmedetomidine versus propofol in the medical intensive care unit (micu)

Conditions: Mechanical Ventilation; Critical Illness

Summary: this is a randomized controlled trial to compare propofol to dexmedetomidine for prolonged sedation (\> 24 hours) in critically ill patients who require mechanical ventilation.

mechanically ventilated critically ill patients are routinely given sedative and analgesic medications to relieve pain and anxiety associated with intubation, mechanical ventilation, and critical care in general. while integral in minimizing discomfort, these medications may increase mechanical ventilation time, the duration of intensive care unit (icu) stay, icu complications (e.g. delirium, ventilator associated pneumonia, venous thromboembolism), the morbidity associated with critical illness, and patient mortality. this study compares two sedative medications that have been used in patients who require a mechanical ventilator. enrolled patients will be randomly assigned to receive propofol or dexmedetomidine for sedation while they require ventilatory support. all patients will also receive the pain medication fentanyl as needed.

Eligibility criteria:
inclusion criteria: * \>18 years old * mechanically ventilated through endotracheal tube * anticipated need for ventilation \> 48 hours * requiring sedative/analgesic medication exclusion criteria: * on mechanical ventilator \> 96 hours * primary neurologic disease * post cardiac arrest * do not speak english (assessment only english language validated) * pregnancy or lactation * active myocardial ischemia * second or third degree heart block * pancreatitis * elevated serum triglycerides (\> 400 mg/dl)

Keywords: hypnotics and sedatives respiration, artificial ventilators, mechanical critical care intensive care physical therapy occupational therapy sedative medications