Kornimate/medical-research-clean huggingface dataset:
genetics of familial and sporadic als

Conditions: Amyotrophic Lateral Sclerosis (ALS); Familial Amyotrophic Lateral Sclerosis; ALS With Frontotemporal Dementia (ALS/FTD); Lou Gehrig's Disease; Motor Neuron Disease (MND); Primary Lateral Sclerosis (PLS); Sporadic ALS (SALS)

Summary: we are collecting blood samples, clinical and family information from als (amyotrophic lateral sclerosis) patients and their families to identify causes of als and als/dementia.

the investigators' long term goals are to improve diagnosis and develop effective treatments that arrest or ameliorate symptoms of als, and possibly delay or prevent disease onset in individuals at risk for developing familial als (fals). in order to do this one must understand how disease develops at a molecular level. identification of genes that increase risk for developing all types of als will reveal the pathways of molecular events that are involved in als. the investigators are collecting blood samples, family and medical histories of patients with all types of als, (familial and sporadic, with and without frontotemporal dementia, and primary lateral sclerosis and particular family members. samples are coded to maintain confidentiality. travel is not necessary. as well as seeking to identify new genes implicated in als, the investigators continue our study of families with known genetic mutations to more fully characterize that disease mechanism. linkage analysis and affected relative pair analysis will be used to identify causative fals genes and disequilibrium analysis and association studies are being done for sporadic als. results from these studies will provide insight into the underlying disease mechanisms of als and provide targets for therapeutic interventions.

Eligibility criteria:
inclusion criteria: * patients with amyotrophic lateral sclerosis or als and frontotemporal dementia * selected family members, generally brothers and sisters of an als patient, the patient's parents exclusion criteria: * under 18 years old

Keywords: fals als als/ftd sals mnd pls
a study to compare efficacy and safety of zolpidem modified release formulation versus zolpidem in insomnia patients

Conditions: Sleep Initiation and Maintenance Disorders; Primary Insomnia

Summary: the purpose of this study is to investigate the efficacy and safety of zolpidem mr (modified release) compared to zolpidem ir (immediate release) in patients with primary insomnia.


Eligibility criteria:
inclusion criteria: * diagnosis of primary insomnia based on dsm-iv criteria (307.42) * written informed consent has been obtained exclusion criteria: * patients with sleep apnea syndrome, narcolepsy, presence or suspicion of periodic leg movement or restless leg syndrome * patients with hepatic failure, myasthenia gravis, or hypersensitivity to zolpidem * patients who are known to be current drug or alcohol abuser or likely to concomitantly consume alcoholic beverages (more than 3 times/week) * patients who have received antihistamines or antipsychotics will not allow to discontinue the previous medication throughout the study * patients who are pregnant, lactating or intend to become pregnant during the study period * patients who have received antidepressants or anxiolytics will not allow to change the dose or discontinue the previous medication throughout the study * any clinically significant condition, which in the opinion of the investigator makes the patients unsuitable for the trial * participation in any clinical trial within 1 month prior to randomization

Keywords: insomnia zolpidem
proof of concept to assess the feasibility of a decentralised pathway coordinated by the advanced practice nurse for patients receiving oral treatment for cancer or malignant haemopathy (acceler platform)

Conditions: Solid Cancer; Haematological Malignancies

Summary: this is an open-label, single-centre, category 2 "jardé law" proof-of-concept study designed to demonstrate the feasibility of a decentralised care pathway for patients with cancer or haematological malignancies receiving oral treatment. the study will be conducted on a population of 33 patients. in current practice, patients with certain solid cancers or haematological malignancies may be prescribed oral chemotherapy on a retroceded basis. in these cases, the oncologist (coordinating investigator) sees the patient for a consultation every 3 cycles to prescribe/renew the treatment for approximately 3 months. every month, the patient returns to the centre to have the treatment dispensed by the hospital pharmacy. no medical consultation is associated with this visit. in this study, it is proposed to decentralise the delivery of treatment to these patients by introducing two visits to the patient's home by a service-providing nurse. the decentralised patient pathway will be organised and monitored by the advanced practice nurse (apn) at the investigating centre, who will be responsible in particular for coordination with the service-providing nurse and the hospital pharmacy.


Eligibility criteria:
inclusion criteria: 1. patient over 18. 2. a patient with solid cancer or haematological malignancy receiving oral retroceded therapy as part of standard management. 3. patient with a performance index (ecog): 0-2. 4. patient contactable by telephone for follow-up by the advanced practice nurse. 5. patient willing to make two home visits within 6 months of inclusion. exclusion criteria: 1. pregnant or breast-feeding patient. 2. any psychological, family, geographical or social condition which, in the judgement of the oncologist, could potentially prevent the collection of informed consent or hinder compliance with the study protocol. 3. patients deprived of their liberty by administrative or legal decision, or patients under guardianship.

Keywords: retroceded oral chemotherapy
to investigate efficacy of yaz in the treatment of dysmenorrhea

Conditions: Dysmenorrhea

Summary: the objective of this study is to investigate the safety and efficacy of (0.02 mg ee as betadex clathrate \[β-cdc\]) / 3 mg drospirenone (drsp) for dysmenorrhea. in order to appropriately evaluate the efficacy of ee(β-cdc)/drsp the study was set up as a placebo-controlled comparative study


Eligibility criteria:
inclusion criteria: * patients suffering from dysmenorrhea for at least the previous 3 months prior to visit 1 with a minimum visual analogue scale (vas) score of 30 mm with regard to pain during the menstrual period of the screening period * good general health (except for findings related to dysmenorrhea) as proven by medical history * patients aged 18 years or older at the time of obtaining informed consent; smokers must not be older than 35 years at the time point of informed consent * normal or clinically insignificant cervical smear not requiring further follow up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous six months). human papilloma virus (hpv) testing in subjects with atypical squamous cells of undetermined significance (ascus) can be used as an adjunctive test. subjects with ascus can be included if they are negative for high-risk hpv strains (hpv 16, hpv18). * women of childbearing potential must agree that adequate contraception will be used when they are sexually active. this applies from signing of the informed consent form until 2 weeks after the last study drug administration. exclusion criteria: * pregnancy (confirmed or suspected) or lactation (less than three months since delivery, abortion, or lactation before start of treatment) * patients who wish to become pregnant during the course of the study * body mass index (bmi) \> 32 kg/m2 * hypersensitivity to any ingredient of the study drug * laboratory values outside inclusion range before randomization * any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication * any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results * any disease or condition that may worsen under hormonal treatment according to the assessment and opinion of the investigator.
vaginal compared with intramuscular progesterone for prevention of preterm birth in high risk pregnant women

Conditions: Premature Birth

Summary: this study is for compare the efficacy of two different regimens(vaginal vs intramuscular) of progesterone therapy in prevention of preterm birth in high risk pregnant women.

the objectives of this study is 1) to compare the efficacy of two different regimens of progesterone therapy in preventing preterm birth less than 37 weeks of gestation. 2) to compare the cost-benefit, adverse effects and patient preference of two different regimens of progesterone therapy. design: multi-center, randomized, open-label trial

Eligibility criteria:
inclusion criteria: * with a history of prior spontaneous preterm birth or short cervix length * spontaneous preterm birth: preterm birth \<37 weeks of gestation due to spontaneous preterm labor or preterm premature rupture of membranes (pprom) * short cervix length : cervix length \<25 mm as measured by transvaginal ultrasound at 16-24 weeks of gestation exclusion criteria: * multiple gestations * major congenital anomalies * elective prophylactic cervical cerclage \<16 weeks of gestation during current pregnancy * previous intentional preterm birth due to maternal or fetal indications, such as preeclampsia and fetal growth restriction * diabetes, hypertension, other severe medical diseases

Keywords: premature birth progesterone
tongji maternal and child health cohort

Conditions: Weight Gain; Maternal; Diabetes Mellitus, Affecting Fetus; Diet Habit; Pregnancy Complications; Birth Outcomes; Breast Feeding; Growth and Development

Summary: this is a population-based study to obtain data for the evaluation of current used recommendations for weight gain during pregnancy released by iom (2007) and investigate the association between maternal diet and the health outcomes of mother and offspring.

this is an ongoing population-based prospective cohort study to obtain data for the evaluation of current used recommendations for weight gain during pregnancy released by iom (2007) and investigate the association between maternal diet and the health outcomes of mother and offspring. 8649 pregnant have been recuited from the first trimester of pregnancy. all datas including the general information, sociodemographic facts, physical exam (body weight, height, blood pressure, etc), laboratory test (hemoglobin, glucose concentration, etc.) and dietary survey (ffq, 24h food recall) have been collected during the cohort study. blood sample leftover from the clinical use are remained and stored at -80℃for further measurements. obstetric characteristics, maternal and perinatal outcomes have been observed and recorded. growth and development paremeters such as weight, length and head circumference as well as disease information of infants have been collected , feeding pattern and feeding history will be surveyed. all data collected will be used for group analysis only and all private and individual records will be kept secret.

Eligibility criteria:
inclusion criteria: * pregnant women attending the first visit (\<16 weeks ) at at a maternity clinic in one of these following hospitals in wuhan, china: hmchh, chw,wmchh,jmchh. intention to visit the maternity clinic regularly in hmchh or chw or wmchh or jmchh. * intention to eventually deliver in hmchh or chw or wmchh. * the pregnant woman and her husband are chinese. exclusion criteria: * pregnant women on chemotherapy. * exclude women on certain medications - e.g. psychotropic drugs. * exclude women with significant medical conditions e.g. psychosis etc.
effect of live combined bifidobacterium,lactobacillus and enterococcus capsules on oral mucositis in nasopharyngeal carcinoma patients receiving radiotherapy.

Conditions: Oral Mucositis; Quality of Life

Summary: effect of live combined bifidobacterium,lactobacillus and enterococcus capsules on oral mucositis in nasopharyngeal carcinoma patients receiving radiotherapy.

radiation-induced mucositis is an acute reaction of the mucosa of patients undergoing head and neck radiotherapy.it can lead to dose-limiting and debilitating side effect. there is no guideline on an acknowledged intervention that significantly reduces its severity. in the mucosa, the immune system's t cells and b cells have position-specific phenotypes and functions that are influenced by the microbiota. these cells play pivotal parts in the maintenance of immune homeostasis by suppressing responses to harmless antigens and by enforcing the integrity of the barrier functions of the gut mucosa.we designed a randomized trial of live combined bifidobacterium,lactobacillus and enterococcus capsules in patients with nasopharyngeal carcinoma. the aim of this study was to determine if regulating intestinal tract flora was effective in reducing the severity of radiation-induced mucositis in patients receiving radical dose radiotherapy. the effect of this intervention on a patient's general well-being was also investigated. the primary end-point of the study was the incidence of radiation therapy oncology group grade 3 mucositis.in 2017, 40 patients are estimated to be recruited into the study at jiangxi cancer hospitals, china.20 patients were randomized to receive live combined bifidobacterium,lactobacillus and enterococcus capsules and 20 to receive a placebo.

Eligibility criteria:
inclusion criteria: karnofsky score ≥80 newly diagnosed npc without distant metastasis confirmed by pathology without any other malignant disease history no any other anti-cancer treatment for npc previously received radiotherapy and chemotherapy at our cancer center exclusion criteria: any immune system disease under high risk to antimicrobial agents such as diabetes,infection disease
correlation between maternal vitamin d level and preterm birth

Conditions: Preterm Birth; Preterm Labor; Vitamin D Deficiency

Summary: assessment of correlation between vitamin d level and prevalence of preterm births remains limited. the exact role of vitamin d in preterm birth has not yet been clearly defined ,where some studies showed vitamin d deficiency increased the risk of preterm birth while other studies found no correlation. in this study will try to continue research on this subject.


Eligibility criteria:
inclusion criteria: * singleton gestation. * maternal age: 20-35 years. exclusion criteria: 1. multi fetal pregnancy. 2. anatomical or genetic defect of the fetus. 3. iatrogenic preterm delivery. 4. maternal medical disorder e.g diabetes millets (d.m). 5. antepartum hemorrhage. 6. hypertensive disorders. 7. polyhydromins or oligolydromins 8. premature rupture of membranes ± chorioamnionitis 9. incompetent cervix. 10. post ivf. 11. uterine fibroid or malformation.
transcranial direct current stimulation (tdcs) and cognitive task in depression

Conditions: Depression

Summary: among antidepressant treatments, electroconvulsive therapy (ect) remains the most effective. however, patient concerns with cognitive side effects have encouraged trials of new, non-convulsive forms of mild brain stimulation such as transcranial direct current stimulation (tdcs). our past and present studies of tdcs suggest that it has antidepressant effects and is safe, painless and well tolerated. however, not all patients may have an adequate response, raising the need to find ways of optimising efficacy. this clinical pilot study will examine the feasibility and safety of combining tdcs with a cognitive training task which engages the same brain region targeted by tdcs for treatment of depression.


Eligibility criteria:
inclusion criteria: 1. participants are aged 18-65 years. 2. participant meets criteria for a dsm-v major depressive episode. criteria are as follows: five or more symptoms present during the same 2-week period, including either 1 or 2: 1) depressed mood, 2) loss of interest or pleasure, 3) significant weight loss or gain, 4) insomnia or hypersomnia, 5) psychomotor agitation or retardation, 6) fatigue or loss of energy, 7) feelings of worthlessness or excessive or inappropriate guilt, 8) diminished ability to think concentrate or make decisions, and 9) recurrent thoughts of death, recurrent suicidal ideation, suicide attempt or plan. 3. madrs score of 20 or more. 4. right handed 5. a history of non-response to ≥ 2 adequate trials of antidepressant medication treatment. exclusion criteria: 1. dsm-v psychotic disorder. 2. drug or alcohol abuse or dependence (preceding 6 months). 3. inadequate response to ect (current episode of depression). 4. regular benzodiazepine medication 5. rapid clinical response required, e.g., due to high suicide risk. 6. clinically defined neurological disorder or insult. 7. metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites. 8. pregnancy.
comparative study between lyophilized or frozen bone allografts for sinus-lifting

Conditions: Disorder of Maxillary Sinus; Accessory; Bone; Bone Atrophy

Summary: bone resorption and atrophy in maxillary posterior region is due to severe periodontal disease and is consequent tooth extractions. sinus pneumatisation can occur after tooth extraction and alveolar bone loss. consequently, bone-reducing volume at that region is a great challenge to implantodontists. sinus lifting surgery have been practiced since 80's and many biomaterials have been used to solve filling issues to maintain the sinus floor lifted in a position that can allow dental implants installation. bone grafts have shown to be the best choice of filling grafts. despite autologous bone are the gold standard filling biomaterial it is associates with great mortality and morbidity. so, bone allografts from tissue bank had been shown to be an advantageous alternative. lyophilized or freeze tissue bone are the most common allografts but literature is poor in randomized controlled parallel clinical trials regarding those filling grafts for sinus lifting. the aim of this study is to perform a randomized controlled clinical trial comparing two bone allografts: lyophilized and freeze bone allografts from human bone tissue bank. the investigators want to verify which one can develop greater osteogenesis, if is there any difference between them regarding the architectural trabeculae formation, if there are different patterns of reabsorption and finally if is there any differences between them regarding primary and lately dental implants stability. to answer those questions the investigators propose firstly, to carry out microtomographic and histological analysis from trephine bone samples after six months of sinus lifting and grafting in healthy participants undergoing osseointegrated dental implants. secondly, the primary and lately implant stability is going to be achieved employing resonance frequency analysis (rfa).


Eligibility criteria:
inclusion criteria: * healthy * totally or partially edentulous patients, bilaterally, in upper premolar or molar region; presenting maxillary sinus lifting necessity with bilateral alveolar bone height lower than 5mm and indication for at least one osseointegrated dental implant in premolar or molar region. exclusion criteria: * recent sinusitis history * hypersensibility for sinus allergens, tabagism, ethylism * severe periodontal disease, diabetes, hypertension. * cases that occur schneiderian membrane perforation will be excluded from the final sample.

Keywords: bone maxillary sinus
investigating the protective impact of ly-2940094 on stress-induced depression- and anxiety-related phenotypes in humans

Conditions: Depression - Major Depressive Disorder; Anxiety; Stress

Summary: this project will integrate pharmacological and psychophysiological methodology to mechanistically investigate, in humans, the role of n/ofq in laboratory phenotypes of both disorders. specifically, a n/ofq receptor (nopr) antagonist will be used to test the hypothesis that nopr blockage will have antidepressant-like effects (potentiate reward processing); in addition, this study will also evaluate a key anxiety phenotype (fear learning). finally, the impact of recent life stress on these processes will be assessed. results will demonstrate the specificity of nopr blockage on depressive phenotypes or suggest a common pathway for emotional disorders and will confirm a modulatory role of life stress.


Eligibility criteria:
inclusion criteria: * absence of medical, neurological, and psychiatric illness (including alcohol and substance abuse), as assessed by subject history and a structured clinical interview (diagnosed using the scid-5) * written informed consent * absence of any medications for at least 3 weeks exclusion criteria: * subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician * pregnant women or women of childbearing potential who are not using a medically accepted means of contraception * serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease * history of seizure disorder * history or current diagnosis of any of the following dsm-iv psychiatric illnesses: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, obsessive-compulsive disorder, patients with mood congruent or mood incongruent psychotic features, substance dependence, substance abuse within the last 12 months (with the exception of cocaine or stimulant abuse; which will lead to exclusion) * history of cocaine or stimulant use (e.g., amphetamine, cocaine, methamphetamine) * history of use of dopaminergic drugs (including methylphenidate) * history or current diagnosis of dementia * patients with mood congruent or mood incongruent psychotic features * current use of other psychotropic drugs * clinical or laboratory evidence of hypothyroidism * patients with a lifetime history of electroconvulsive therapy * abnormal ecg and lab results * history of seizure disorder or currently on anticonvulsants
staccato loxapine thorough qt/qtc study

Conditions: Thorough QT/QTc Study

Summary: the purpose of the present phase 1 study was to assess the cardiac safety of staccato loxapine administered to healthy volunteers in a 3 period crossover study.

primary objective: to assess the maximum effect of staccato loxapine on cardiac repolarization (qtc interval duration) at the anticipated maximum clinical dose compared to placebo in healthy volunteers. secondary objective: to assess the qtc versus loxapine concentration relationship following treatment with staccato loxapine in healthy volunteers.

Eligibility criteria:
inclusion criteria: * subjects who are in good general health and agree to use a medically acceptable and effective birth control method throughout the study. exclusion criteria: * subjects who have taken prescription or nonprescription medication within 5 days of treatment, * subjects who have had an acute illness within the last 5 days of treatment, * subjects who are smokers, or * subjects who have an ecg abnormality at baseline.

Keywords: staccato loxapine qt/qtc healthy volunteers thorough qt/qtc study adasuve inhaled loxapine