Kornimate/medical-research-clean huggingface dataset:
to compare the safety and pharmacokinetics of pt105 with pt105r in healthy postmenopausal female volunteers

Conditions: Prostate Cancer

Summary: the purpose of study is to compare the safety and pharmacokinetics of pt105 with pt105r in healthy postmenopausal female volunteers

the purpose of study is to confirm the safety and pharmacokinetics of pt105 in healthy postmenopausal female volunteers

Eligibility criteria:
inclusion criteria: * a healthy woman who is over 19 years of age and has been certified obstetrically with menopause, at the time of screening. * subjects weighing over 50 kg with bmi between 18 and 30 kg/m2 (inclusive) at screening visit. exclusion criteria: * those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history * those whose plasma ast and alt exceed 2 times to the upper limit of the normal range in screening including additional examinations prior to randomization * subjects who have participated and taken investigational drug in any other clinical trial (including bioequivalence study) within six months prior to study drug administration * subjects who have donated a unit of whole blood within two months or blood components within one month prior to study drug administration
evaluation on standardized circuits of the interest of a robotic module of assistance to the driving

Conditions: Neurological Disorders

Summary: the device that is the subject of this investigation is a robotic assistance module for driving a semi-autonomous electric wheelchair. this module is designed to accessorize the electric wheelchair to improve the safety conditions when driving an electric wheelchair, thus reducing the wheelchair accident rate on the one hand and facilitating access to the wheelchair to persons who can not claim it without the use of a safety device of this type.

the device that is the subject of this investigation is a robotic assistance module for driving a semi-autonomous electric wheelchair. this module is designed to accessorize the electric wheelchair to improve the safety conditions when driving an electric wheelchair, thus reducing the wheelchair accident rate on the one hand and facilitating access to the wheelchair to persons who can not claim it without the use of a safety device of this type. each patient included will test a wheelchair equipped with a collision avoidance assistance module in 2 conditions, assistance activated or not. this evaluation will be carried out in 3 standardized test circuits of increasing difficulty, one week apart. at each session, the patient will perform the circuit 6 times, including 3 with activated assistance, in a random order established upstream.

Eligibility criteria:
inclusion criteria: * aged over 18, * having freely consented to participate in the study, * suffering from neurological disorders such as cerebro-lesion or neuro-degeneration, * having benefited from a prescription of electric wheelchair and circulating in an electric wheelchair for more than 3 months, * of which the electric wheelchair is the main mode of transport, * the physical measurements (weight, height) are compatible with the use of the electric wheelchair chosen for the development of the robotics assistance module. exclusion criteria: * understanding difficulties preventing the realization of the protocol, * motor disorders of the upper limb requiring additional driving technical assistance, * patient having expressed difficulties impacting his safety of sedan and / or exterior.
support to reunite involve and value each other

Conditions: Family Relations; Runaway Behavior; Risky Sexual Behavior; Substance Use

Summary: runaway and homeless youth are at risk for hiv based upon their rates of substance use, particularly injection drug use, unprotected sexual intercourse, multiple partners, and sexually transmitted diseases. risk increases as the time away from home increases. strive is a family intervention aimed at increasing residential stability, decreasing runaway episodes, and decreasing hiv risk. families are randomly assigned to a cognitive-behavioral skills-building intervention consisting of five weekly sessions delivered at family homes, or are assigned to standard care. sessions are aimed at increasing problem solving, role clarity, and positive interactions. it is hypothesized that the intervention will result in improved family dynamics, less runaway behavior, and less risky behavior.


Eligibility criteria:
inclusion criteria: * youth: age 12-17 who ran away or were told to leave home within the past 6 months. must provide assent and parent/guardian must provide informed consent. * parent/guardian: must be parent/guardian of participating youth who ran away. must provide informed consent. exclusion criteria: * youth: total time away from home exceeds 12 months. obvious cognitive impairment. sexual or physical abuse from the parent/guardian. lack of assent/consent. * parent/guardian: obvious cognitive impairment. lack of consent.

Keywords: runaway youth homeless youth family intervention family functioning hiv risk behavior hiv seronegativity
study to evaluate the efficacy, safety, and tolerability of imu-838 in patients with relapsing multiple sclerosis

Conditions: Multiple Sclerosis

Summary: multi-center, randomized, double-blinded phase 3 study to evaluate the efficacy, safety, and tolerability of imu-838 versus placebo in adults with relapsing multiple sclerosis (ensure-1)

this study will be a multicenter, randomized, double-blind, placebo-controlled study with a blinded main treatment period (mt) and an open label period (ole) to evaluate the efficacy, safety, and tolerability of imu-838 in adult patients with rms. the study will consist of the following periods: screening period: approximately 28 days main treatment period: up to 72 weeks (approximately 15 months) open label extension period: up to approximately 8 years

Eligibility criteria:
inclusion criteria: * male or female patient (age ≥18 to ≤55 years). * patients with an established diagnosis of ms according to 2017 mcdonald criteria. * patients with rms comprising of relapsing remitting ms (rrms) and active secondary progressive ms, both defined according to lublin criteria 1996 and 2014. * active disease as defined by lublin 2014 evidenced prior to screening by: 1. at least 2 relapses in the last 24 months before randomization, or 2. at least 1 relapse in the last 12 months before randomization, or 3. a positive gd+ mri scan (brain and/or spine) in the last 12 months prior to randomization. * willingness and ability to comply with the protocol. * written informed consent given prior to any study-related procedure. exclusion criteria: * patients with non-active secondary progressive ms and primary progressive ms. * any disease other than ms that may better explain the signs and symptoms, including history of complete transverse myelitis. * clinical signs or presence of laboratory findings suggestive for neuromyelitis optica (nmo) spectrum disorders or myelin oligodendrocyte glycoprotein (mog)-igg-associated encephalomyelitis * any active and uncontrolled coexisting autoimmune disease, other than ms (except for type 1 diabetes mellitus and inflammatory bowel disease) * use of experimental/investigational drug (with the exception ofcovid-19 vaccines approved by emergency use authorization) and/or participation in drug clinical studies within 6 months prior to screening * previous or current use of ms treatments lifelong, or within a pre-specified time period. * use of the pre-specified concomitant medications. * clinically significantly abnormal and pre-specified lab values. * history of chronic systemic infections within 6 months before the date of informed consent. * diagnosis or suspected liver function impairment, which may cause fluctuating liver function tests during this study. * known history of nephrolithiasis or underlying condition with a strong association of nephrolithiasis. * history or clinical diagnosis of gout. * history or presence of any major medical or psychiatric illness * substantial medical condition that could create undue risk to the patient, could affect adherence with the study protocol or could undesirably affect study outcomes
stereotactic body radiotherapy versus conventional radiotherapy in medically-inoperable non-small lung cancer patients

Conditions: Non-small Cell Lung Cancer

Summary: a multi-centre randomized controlled open-label trial in medically inoperable patients with biopsy-proven early stage non-small cell lung cancer (nsclc). eligible and consenting patients will be randomly allocated to receive stereotactic body radiotherapy (sbrt) or conventional radiotherapy (crt) in a 2:1 ratio. radiotherapy will be administered as soon as possible following randomization and subjects will be followed for 5 years post-randomization for cancer recurrence, toxicity and survival. the primary outcome is local control (lc). the trial will be conducted at 16-20 clinical centres throughout canada.


Eligibility criteria:
inclusion criteria: 1. t1/t2a n0 m0 nsclc, either by: (a) histological confirmation (squamous cell, adenocarcinoma, large cell carcinoma, or not specified) and ct thorax and/or pet-ct evidence, or (b) a suspicious growing nodule on serial ct imaging, with malignant pet fluorodeoxyglucose (fdg) avidity, for which a biopsy would be extremely risky. 2. deemed medically inoperable (as reviewed by a thoracic surgeon and defined as surgically resectable but, because of underlying physiological medical problems \[e.g. chronic obstructive pulmonary disease (copd), heart disease\], surgery is contraindicated) or radiotherapy is preferred by the patient due to high operable risk. exclusion criteria: 1. less than 18 years of age. 2. eastern cooperative oncology group (ecog) performance status 3 or higher. 3. prior invasive malignancy within the past 3 years (excluding non-melanomatous skin cancer). 4. history of ataxia telangiectasia. 5. previous radiotherapy (rt) in the vicinity of the tumour, such that significant overlap could occur. 6. previous pneumonectomy with stage i lung cancer in the remaining lung. 7. diagnosis of idiopathic pulmonary fibrosis and/or interstitial lung disease. 8. planned for other anticancer therapy (chemotherapy, biological targeted therapy). 9. female, who is currently pregnant or lactating. 10. geographic inaccessibility for follow-up. 11. unable to provide informed consent.

Keywords: stereotactic body radiotherapy conventional radiotherapy inoperable patients local control cancer recurrence toxicity survival
post covid syndrome: clinical pattern and functional assessment

Conditions: Covid19

Summary: aim(s) of the research : 1. identify post covid symptoms 2. prevalance of post covid syndrome among survivours

there is currently very limited information on the nature and prevalence of post-covid-19 symptoms after hospital discharge. on 11th march 2020, corona virus disease 2019 (covid-19) was declared a global pandemic by the world health organisation (who). egypt has been one of the worst affected countries with over 101,500 confirmed cases and more than 5,696 confirmed deaths at the time of writing (17/9 2020) .1 covid-19 is caused by the corona virus sarscov-2 and presents with a wide spectrum of clinical symptoms. wu et al reported that 81% of people with covid-19 in china presented with mild symptoms; 14% presented with symptoms of severe respiratory dysfunction; and 5% developed a critical illness with respiratory failure, septic shock, and multiple organ dysfunction or failure.2 the medium and long-term problems experienced by survivors of covid-19 after discharge from hospital are currently unknown, but there is some emerging evidence. an italian study followed-up 143 individuals 7 weeks post-discharge and found 53% reporting fatigue, 43% breathlessness and 27% joint pain.3 post-discharge symptoms may also be predicted from the previous coronavirus outbreaks of severe acute respiratory syndrome (sars) in 2002 and middle east respiratory syndrome (mers) in 2012. a meta-analysis of 28 follow-up studies found that one quarter of hospitalised survivors of sars and mers had reduced lung function and exercise capacity at six months post-discharge.4 at one year, post-traumatic stress disorder (ptsd), depression and anxiety, and reduced quality of life were observed specific data concerning the rehabilitation needs of this group is therefore urgently required.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed as covid 19 with chest ct and/or nasopharyngeal swab for covid 19 2. age 18 years old and above 3. post covid syndrome after 6 weeks exclusion criteria: * 1-below age of 18 2 -not confirmed cases 3. symptoms less than 6 weeks
low pain prediction in cesarean section patients

Conditions: Scheduled Cesarean Sections; Postoperative Pain Management; Side Effects

Summary: the investigators are attempting to see if eliminating the amount of long acting spinal narcotic during cesarean section delivery will demonstrate pain scores with movement when evaluated 24 hours postoperatively as those that receive the standard dosage of spinal narcotic when combined with oral acetaminophen or placebo. the investigators also are evaluating if there are decreased side effects related to decreased narcotic usage.

subjects are randomized on the morning of surgery to receive a standard dose of spinal narcotic or to receive no long acting spinal narcotic. the subjects may or may not also receive acetaminophen orally postoperatively. pain scores are done on postoperative day one as well as evaluation of potential narcotic side effects such as nausea/vomiting, itching, and sedation.

Eligibility criteria:
inclusion criteria: * anticipated pain level estimated to be in the lowest 20th percentile (calculated \<34.3 utilizing our standard preoperative questionnaire) * age \>/= 18 * not allergic to any study medications to be utilized in this study * singleton pregnancy exclusion criteria: * allergies to morphine or acetaminophen * diagnosis of a chronic pain disorder * weight \>300 lbs * hepatic disease

Keywords: postoperative pain narcotic side effects
studying dna in samples from younger patients with down syndrome and acute myeloid leukemia treated on cog-aaml0431 clinical trial

Conditions: Leukemia

Summary: rationale: studying samples of blood, tissue, and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. purpose: this research trial studies dna samples from patients with down syndrome and acute myeloid leukemia treated on cog-aaml0431 clinical trial.

objectives: * to identify new genetic abnormalities associated with acute myeloid leukemia (aml) in patients with down syndrome through whole-genome sequencing. outline: this is a multicenter study. extracted dna and rna from cryopreserved specimens are analyzed for genomic sequencing, gene mutation, and microarray analysis.

Eligibility criteria:
disease characteristics: * down syndrome children diagnosed with acute myeloid leukemia (aml) or myelodysplastic syndromes (mds) * clinical samples from patients enrolled on the children's oncology group (cog) aaml0431 phase iii clinical trial, and from the children's hospital of michigan cell bank * diagnostic blast samples and matched remission samples patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: childhood myelodysplastic syndromes childhood acute myeloid leukemia/other myeloid malignancies childhood acute megakaryocytic leukemia (m7)
role of laparoscopy in unexplained infertility

Conditions: Infertility

Summary: in this randomized controlled trial the investigators were looking for the best policy for management of women with unexplained infertility after normal hysterosalpingogram (hsg). the investigators test the hypothesis that postponing or even bypassing laparoscopy does not affect the outcome of management of women with apparently unexplained infertility.


Eligibility criteria:
inclusion criteria: * failure of conception for at least one year * no pathology demonstrated after the standard infertility work-up including semen analysis, mid-luteal serum progesterone for confirming ovulation and hysterosalpingography for documenting tubal patency * diagnosed as having unexplained infertility

Keywords: laparoscopy unexplained infertility
espbs vs taps for satisfactory analgesia following diep surgery

Conditions: Pain

Summary: breast cancer is the second most common cancer diagnosed in american women . for patients who have undergone surgical mastectomy, autologous breast reconstruction is an alternative option to breast implants. deep inferior epigastric perforator (diep) flaps are the gold standard for autologous breast reconstruction . effective pain control following surgery is imperative and ultrasound-guided bilateral transversus abdominis plane blocks (taps) with the infiltration of local anesthetics, such a bupivacaine are a common regional technique of choice . a newer described technique, bilateral erector spinae plane blocks (espbs) (which also are an infiltration of local anesthetic) present as an alternative approach for post-operative analgesia. espbs have been proven efficacious in reducing intra- and post-operative opioid requirements, lessening the need for rescue analgesics in other similar surgical procedures. the hypothesis is that preoperative bilateral espbs could provide equivalent pain control as a regional analgesic for patients undergoing diep flap surgery when compared to preoperative bilateral taps


Eligibility criteria:
inclusion criteria: * adult women with breast cancer, asa 1-3, undergoing diep flap surgery exclusion criteria: * chronic opioid use contraindications to local anesthetics or regional analgesia inability to communicate intensity of pain on a numeric analog scale
long-term follow-up in patients included in the european sleep apnea data base (esada)

Conditions: Sleep Apnea

Summary: the european database esada, containing data from more than 30,000 patients with very different severities of obstructive sleep apnea (osa) syndrome, prospectively collects data from patients referred to academic sleep laboratories in many european countries (https://esada.med.gu.se/). since 2007, grenoble is one of the two french centers with paris and is a very active participant in this european database for patient inclusion and data exploitation. the first objective of the "esada follow-up and outcomes" project is to collect cardiovascular events during the follow-up of patients in the european database through telephone interviews and a structured questionnaire. other objectives are to collect metabolic events, incident cancers and deaths in the same population using the same mean. an additional objective is to assess the impact of continuous positive airway pressure (cpap, the reference treatment for osa) on the occurrence of cardiovascular and metabolic events and incident cancers, as this is still discussed in the literature.

the european database esada prospectively collects data from patients referred to academic sleep laboratories in many european countries (https://esada.med.gu.se/). since 2007, grenoble is one of the two french centers with paris and is a very active participant in this european database for patient inclusion and data exploitation. a partnership agreement exists between university hospital grenoble (chuga) and esada for the reuse of chuga data. the data collected at chuga as part of the esada-follow-up and outcomes questionnaire are also collected in the other european centers and will be centralized at the level of the coordinating center. esada currently contains data from more than 30,000 patients with very different severities of obstructive sleep apnea (osa) syndrome. one of the main limitations of this cohort is the relatively limited amount of information concerning the long-term follow-up of the patients included in the registry. the first objective of the "esada follow-up and outcomes" project is to collect cardiovascular events during the follow-up of patients in the european database through telephone interviews and a structured questionnaire. other objectives are to collect metabolic events, incident cancers and deaths in the same population using the same mean. an additional objective at the end of this data collection is to aggregate the follow-up data of more than 10,000 patients from all participating european centers to assess the impact of continuous positive airway pressure (cpap, the reference treatment for osa) on the occurrence of cardiovascular and metabolic events and incident cancers, as this is still discussed in the literature.

Eligibility criteria:
inclusion criteria: * already included in the esada european database exclusion criteria: * refusal to participate

Keywords: sleep apnea follow-up cardiovascular event metabolic event incident cancer death
linking education, produce provision, and community referrals to improve diabetes care (link)

Conditions: Diabetes Mellitus, Type 2; Nutrition Poor; Food Deprivation

Summary: this is a pragmatic randomized controlled trial (prct) that aims to test the effect of produce provision, diabetes education, and community referrals on hemoglobin a1c levels in individuals with type 2 diabetes experiencing food insecurity.

link (linking education, produce provision, and community referrals to improve diabetes care is a 6-month pragmatic randomized controlled trial (prct) using a 2x2 factorial design to prospectively enroll study participants with type 2 diabetes and food insecurity into one of four study arms. the four study arms are: 1) mid-ohio farmacy (receiving weekly produce through a consortium of local food banks); 2) mid-ohio farmacy + cooking for diabetes (cooking for diabetes is a 6-week diabetes and culinary education intervention); 3) mid-ohio farmacy + health impact ohio pathways hub (the pathways hub uses a community health worker model to meet with participants, evaluate and address non-medical, health-related social needs); and 4) mid-ohio farmacy + cooking for diabetes + health impact ohio pathways hub). participants will be enter participants will be randomized using a 1:1:1:1 stratified randomization scheme built into research electronic data capture (redcap) at the participant level. primary and secondary outcomes will be collected at baseline, 3 and 6 months.

Eligibility criteria:
inclusion criteria: * type 2 diabetes based on american diabetes association criteria * hemoglobin a1c ≥ 7.5% * screen positive on 2-item food security screener exclusion criteria: * unwilling to attest to release of information to mid-ohio food collective

Keywords: food insecurity social determinants of health non-medical, health related social needs diabetes self-management education and support