Kornimate/medical-research-clean huggingface dataset:
actramat-d: impact of post-traumatic stress disorder after pregnancy loss after 12 weeks of gestation

Conditions: Pregnancy Loss

Summary: in france the prevalence of pregnancy loss after 12 weeks of gestation is around 3%. this situation is probably associated to a risk of post-traumatic stress disorder. as a part of the medical staff midwives are often confronted with this situation, however they can have difficulties to identify short and long term effects of a post-traumatic stress disorders. the purpose of the present study is to estimate and analyze the prevalence of short-term (1 month) post-traumatic stress disorder in women with pregnancy loss after 12 weeks of gestation.the symptoms of post-traumatic stress disorder will be tracked using the impact of event scale-revisited and the peritraumatic dissociative experiences questionnaires.the diagnosis of post-traumatic stress disorder will also be clinically confirmed by a psychiatrist during a specific consultation.


Eligibility criteria:
inclusion criteria: * loss pregnancy after 12 weeks of gestation * consent to participate in the clinical study exclusion criteria: * no french speaking * psychiatric disease * participation in another clinical study

Keywords: post-traumatic stress disorder pregnancy loss
fibrosis, valvular and ventricular function in patients with tga

Conditions: Transposition of Great Vessels

Summary: the aim of this project is to better evaluate the systemic right ventricular (rv) function in patients with transposition of the great arteries (tga).

patients with tga frequently develop supraventricular and ventricular arrhythmia, conduction problems, systemic atrioventricular valve (savv) regurgitation, and congestive heart failure (chf), all at young age. however, there is variation in time of onset of these adverse events. we want to evaluate ventricular and valvular function at rest, markers of rv fibrosis and cardiac reserve.

Eligibility criteria:
inclusion criteria: * patients with a tga * informed consent to participate. if the patient is under the age of 18, the assent of the patient and the permission of the parents to participate exclusion criteria: * previous double-switch intervention * any medical contra-indication for cardiovascular magnetic resonance (cmr) imaging (e.g. pacemaker) * the presence of exercise-induced arrhythmia, symptomatic myocardial ischemia, a resting systolic blood pressure \> 200 mm hg and/or diastolic blood pressure \> 110 mm hg, new york heart association (nyha) class iii or iv, or non-cardiac co-morbidity that could aggravate by exercise * additional exclusion criterion for delayed gadolinium enhancement cmr: any medical contra-indication for intravenous gadolinium
solo and non-solo approach for laparoscopic cholecystectomy

Conditions: Cholecystectomy, Laparoscopic

Summary: to determine the safety and feasibility of solo laparoscopic cholecystectomy, which is defined as the application of solo surgery to laparoscopic cholecystectomy, by comparing consecutive non-solo procedures conducted by a surgeon in the presence or absence of human assistant(s).

laporoscopic cholecystectomy usually requires three surgeons, including an operator, a camera assistant, and other instrument assistant. recent advancement of technology made it possible to develop the conveniently adjustable holders for camera and other laparoscopic instruments. the application of these instruments enables "solo-surgery" wherein an operation is driven by single surgeon. during surgery, human assistant(s) are helpful because of their instant assistance according to the operation's need. therefore, the utilization of instruments instead of human assistants would be cumbersome. however, the utilization of instruments would be helpful by enabling operation-driven repositioning of the camera and instrument(s). currently, no attempt has been made to objectively compare the merits and demerits of these two procedures. therefore, this study was conducted to determine the safety and feasibility of solo laparoscopic cholecystectomy, which is defined as the application of solo surgery to laparoscopic cholecystectomy, by comparing consecutive non-solo procedures conducted by a surgeon in the presence or absence of human assistant(s).

Eligibility criteria:
inclusion criteria: 1. the patients planed to undergo elective laparoscopic cholecystectomy 2. benign gallbladder diseases requiring surgery 3. the patients who are indicated for single-port laparoscopic cholecystectomy. exclusion criteria: 1. the patients with complicated cholecystitis 2. the patients with the gallbladder with a thickness more than 4mm. 3. the patients who are expected to have severe peritoneal adhesion. 4. the patients with malignant gallbladder diseases. 5. the patients whose operation appears to need human assistant(s)

Keywords: laparoscopic cholecystectomy solo surgery camera holder cholecystitis
cyproheptadine as an appetite stimulant

Conditions: Failure to Thrive

Summary: cyproheptadine is currently clinically used as an appetite stimulant for children with failure to thrive without underlying organic disease. otherwise, no randomised control trial demonstrates the efficacy of cyproheptadine on those patients. this is precisely what the investigators intend to demonstrate on this randomised placebo control cross-over trial. our hypothesis is that cyproheptadine is more efficient than placebo to improve weight gain and feeding behaviour on 2 to 4 years old children with failure to thrive.


Eligibility criteria:
inclusion criteria: * 2 to 4 years of age * failure to thrive exclusion criteria: * medication affecting appetite * medication interacting with cyproheptadine * prematurity under 36 weeks of gestation * neurologic impairment * underlying organic disease
micro and nanoplastics in greenhouse workers: biomarkers of exposure and effect

Conditions: Microplastics; Nanoplastics; Genotoxic Damage; Inflammation

Summary: mnpls effects on human health are still preliminary. workers exposed to plastic residues are exposed constantly to mnpls. one of these jobs corresponds to greenhouse workers, that could be considered as a population highly exposed to plastics. the objective of the research is to be able to detect mnpls on body fluids as well as their potential genotoxic and immunological damage.

the exponential increase in the production/use of plastic translates into a parallel increase of environmental plastic waste that is continuously degraded into mnpls. information on the mnpls' effects on human health is still preliminary and, furthermore, the limitations in current methodologies prevent accurate exposure/risk assessment. this observational study will obtain body samples of greenhouse workers and from a control group. that would allow optimizing specific biomarkers of human mnpls exposure and the characterization of biomarkers of early effect that allows an association among the exposure to mnpls and effects on human health.

Eligibility criteria:
inclusion criteria of workers exposed to plastic residues: * working in an operating greenhouse for a period of 1 month or more * age over 18 years old * absence of chronic pathology including neoplasia * absence of infectious disease at the date of sample collection and for a period of more than 2 weeks * spanish residence inclusion criteria of controls : * age over 18 years old. matched by age, gender, and lifestyle to the exposed group. * absence of chronic pathology including neoplasia * absence of infectious disease at the date of sample collection and for a period of more than 2 weeks * spanish residence exclusion criteria of workers exposed to plastic residues: * participation in another clinical study * pregnancy * unsigned informed consent exclusion criteria of controls: * participation in another clinical study * pregnancy * unsigned informed consent

Keywords: mnpls; greenhouse workers
investigate the efficacy and safety of brii-835 (vir-2218) and peg-ifnα combination therapy in chronic hbv patients

Conditions: Chronic Hepatitis B Virus Infection

Summary: this study will evaluate the efficacy and safety of peg-ifnα alone or in combination with different dose levels of brii-835 (vir-2218) in participants with chronic hepatitis b virus (hbv) infection.


Eligibility criteria:
inclusion criteria: * male or female aged 18-60. * body mass index ≥ 18 kg/m2 and ≤ 32 kg/m2. * chronic hbv infection for ≥ 6 months. * on nrti therapy for at least 6 months. exclusion criteria: * any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation. * significant liver fibrosis or cirrhosis. * history or evidence of drug or alcohol abuse. * history of intolerance to sc injection. * history of chronic liver disease from any cause other than chronic hbv infection. * history of hepatic decompensation. * contraindications to the use of peg-ifnα.
a phase i/ii clinical trial of vorinostat in combination with erlotinib for patients with relapsed/refractory non-small-cell lung cancer (0683-025)

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the reason for this study will be to find the safest maximum tolerated dose of oral vorinostat in combination with erlotinib \[tarceva (tm)\] that can be given to patients with lung cancer who have relapsed or failed other therapy for the disease. once the safest maximum tolerated dose of vorinostat is determined, patients enrolled in the clinical trial will continue vorinostat and erlotinib for up to 8 months. safety and effectiveness will also be evaluated.


Eligibility criteria:
inclusion criteria: * males and females 18 years of age and older with a confirmed diagnosis of non-small-cell lung cancer (nsclc) who have failed at least one prior treatment for nsclc. * patients must have proven disease by ct scan or mri. * patients must be at least 4 weeks from any chemotherapy for cancer or from any surgeries or from any treatment using an investigational drug. * patients must be 2 weeks out from radiation therapy. * at screening the patient must have normal lab results and can not be pregnant. * women and men must agree to practice adequate birth control during the study. * patient has the ability to understand and sign the consent form. exclusion criteria: * patient had prior treatment with vorinostat or erlotinib. * patient has any of the following conditions: active infections including hepatitis b or c, unstable brain metastases, swallowing difficulties, heart problems, significant eye abnormalities, drug or alcohol abuse, mental illness or pregnancy.

Keywords: relapsed non-small-cell lung cancer refractory non-small-cell lung cancer
waking hypnosis in the treatment of ms-related fatigue

Conditions: Multiple Sclerosis

Summary: the proposed study is a single-center, single-blind three-group randomized (1:1:1) controlled trial (rct) comparing two hypnosis interventions to waitlist control efficacy for ms-related fatigue.

this project will test the efficacy of two different hypnosis approaches for improving ms-related fatigue that have shown to be beneficial for individuals with cancer and other medical conditions in the management of their symptoms. one of these methods, the active-alert hypnosis has helped people to manage fatigue and may have important advantages over the more traditional relaxation hypnotic approaches in the treatment of fatigue, since the hypnotic inductions and the self-hypnosis methods use activation instead of relaxation. therefore, the goals of this study are to determine if a comparison study of these two hypnotic conditions is feasible, and, if so, to determine which treatment may be more effective for helping individuals with ms gain more control over fatigue. additionally, it will explore the mechanisms of these two approaches to hypnosis treatment to determine which might be most helpful to individuals with ms and fatigue.

Eligibility criteria:
inclusion criteria: * diagnosis of ms; * adults 18 years of age or older; * bothersome fatigue (defined as the presence of chronic, problematic fatigue that, in the opinion of the patient, has interfered with their daily activities for ≥ 3 months and average fatigue severity scale score \> to 4 at screening); * ability to read, speak, and understand english and/or spanish. exclusion criteria: * exclusion criteria will be evidence for significant psychopathology that would interfere with study participation, including current suicidal ideation with intent, active psychosis or hallucinations, or severe cognitive impairment.
evaluation of local anesthetic at incision site

Conditions: Post Operative Pain; Appendicitis

Summary: patient will have usual appendectomy surgery with an injection of local or saline at incision site either before or after the incision at random. the clinical hypothesis of this trial is that pediatric patients who undergo a local anesthetic pre-incisional and/or post-incisional will reduce the amount of postoperative pain and therefore reduce the amount of analgesics required to keep the patient satisfied. primary: to determine if local anesthetic reduces postoperative pain. secondary: to assess the timing of local anesthetic injection affects postoperative pain.

this is a prospective randomized-controlled pilot study of 100 pediatric subjects, recruited through phoenix children's hospital and pediatric surgeons of phoenix, who will undergo a laparoscopic appendectomy (la) for acute non-perforated appendicitis. the reviewer and subject will be blind to the treatment to help prevent bias. the subjects will be randomized by envelope using a random number generator, and the infiltrated solution will be given to the surgeon by the pharmacy. the subjects will be approached preoperatively and will be divided into three groups: pre-incisional injection of local anesthetic, post-incisional injection of local anesthetic, and (pre or post) injection of saline as the control. all patients will have a standard 3 port laparoscopic appendectomy, port placement, port and instrument type, and operative technique will be determined by the surgeon's usual practice. on induction, the following protocol will be utilized: a 2 mg/kg bolus of propofol, 1.5 mg/kg of lidocaine, 0.1 mg/kg of morphine, and 0.6 mg/kg of rocuronium. a standardized anesthetic, using a mixture of sevoflurane in oxygen and air, will be utilized. once the appendectomy is complete, a single dose of 0.5 mg/kg of ketorolac will be given prior to extubation. a total of 0.5 ml/kg of 0.25% bupivicaine or saline, up to a maximum of 30 cc, will be injected using a 22g needle. pre-incision: local will be to be given intradermally and onto the peritoneum under direct vision; post-closure local will be injected intradermally after closure. the subjects will be assessed for postoperative pain immediately upon wakening, and then 1, 2, 4, 8, 12, and 24 hours after the la procedure by the bedside nurse by using the vas and by measuring the total amount of opioid use.

Eligibility criteria:
inclusion criteria: * patients undergoing appendectomy for acute non-perforated appendicitis must be between 9-17 years old exclusion criteria: * n/a

Keywords: post operative pain appendicitis appendectomy local anesthetic saline pain management surgery recovery
efficacy and safety study of naproxcinod in subjects with osteoarthritis of the hip

Conditions: Osteoarthritis; Osteoarthritis, Hip

Summary: to study the efficacy and safety of naproxcinod vs. placebo and naproxen in the treatment of signs and symptoms of osteoarthritis.

this is a 13 week randomized, double-blind, parallel group, multicenter study comparing efficacy and safety of naproxcinod, placebo and naproxen.

Eligibility criteria:
inclusion criteria: * men and women (40 or older) with a diagnosis of primary oa of the hip * must be a current chronic user of nsaids or acetaminophen * must discontinue all analgesic therapy at screening exclusion criteria: * uncontrolled hypertension or diabetes * hepatic or renal impairment * current or expected use of anticoagulant * clinically relevant abnormal ecg * a history of alcohol or drug abuse * diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding, within the last 6 months * current medical disease, including arthritic, that could confound or interfere with the evaluation of efficacy * candidates for imminent joint replacement * participation within 30 days prior to screening in another investigational study

Keywords: osteoarthritis osteoarthritis, hip
listening to mom in the nicu: neural, clinical and language outcomes

Conditions: Premature Birth

Summary: the purpose of this study is to examine whether playing recordings of a mother's voice to her infant while in the hospital nursery is an effective treatment for promoting healthy brain and language development in infants born preterm.

children born preterm are at-risk for developmental language delays. language problems in preterm children are thought to be related to neurobiological factors, including injuries to white matter structures of the brain and environmental factors, including decreased exposure to maternal speech in the hospital nursery. there is evidence to suggest that maternal speech input may be important for promoting healthy brain and language development. participants will be randomly assigned to one of two study groups. each infant has a 50% chance of being assigned to the group that will listen to a recording of his/her mother's voice and a 50% chance of being assigned to the group that will not be played a voice recording. mother's of participating infants will have her voice recorded as she reads a common children's storybook. recordings will be played to infants each day until s/he is discharged from the hospital. participation in this study requires that all infants receive up to an additional 10 minutes of brain scans as part of his/her routine clinical magnetic resonance imaging (mri).

Eligibility criteria:
inclusion criteria: * infants born preterm at stanford children's hospital between 27 0/7 - 31 6/7 weeks gestational age exclusion criteria: * congenital anomalies * recognizable malformation syndromes * active seizure disorders * history of central nervous system infections * hydrocephalus * major sensori-neural hearing loss * likelihood to be transferred from nicu to alternate care facility or home environment prior to 36 weeks pma * intraventricular hemorrhage grades iii-iv * cystic periventricular leukomalacia (pvl) * surgical treatment for necrotizing enterocolitis * small for gestational age (sga) \<3 percentile and/or intra-uterine growth restriction (iugr) no head sparing * twin-to-twin transfusions

Keywords: premature birth obstetric labor, premature obstetric labor complications pregnancy complications
fitness to drive among stroke patients

Conditions: Stroke; Driving Impaired

Summary: the goal of this observational study is to learn more about who can continue driving a car after a stroke. the focus of this study is on the relationship between cognitive abilities and fitness-to-drive. participants will be asked to perform an extended neuropsychological testing and a real life on-road test, conducted by a professional driving instructor. feedback will be given to the participants on request.

the relationship between cognitive abilities and driving skills is really complex. this study aims to introduce novel data analysing methods that can be used by medical professionals to decide whether the stroke patient is able to operate a vehicle safely or not. the neuropsychological assessment will involve paper and pencil tests, computerized tests (such as reaction time measurements) and a driving simulator. this part will be approximately 2 hours. since the first part is really tiresome, the test driving will be on an other day. the driving instructor will guide the participant on a standard route, and will evaluate the performance using standard criteria that will focus mainly on traffic safety. who can participate in the study: * aged 65 or younger * holds a driving licence * had an ischemic or hemorrhagic stroke * has sufficient physical abilities to operate a car * does not have certain medical conditions such epilepsy

Eligibility criteria:
inclusion criteria: * 65 or younger * ischemic or hemorrhagic stroke * at least 6 months has passed after the stroke * holds a valid driver's licence exclusion criteria: * visual impairments (eg. visual field loss, nystagmus or diplopia) * epilepsy * serious movement disorders (eg. hemiplegia) that hider operating a car * limb ataxia * aphasia types that affect comprehension * serious psychiatrical disorders

Keywords: fitness to drive neuropsychology cognitive machine learning
pilot proof of concept study of nbmi treatment of mercury intoxication

Conditions: Mercury Poisoning

Summary: a randomized, placebo controlled, double blind proof of concept study of nbmi in treatment of mercury intoxication.

the objectives of this study are to evaluate the efficacy and safety of two doses of nbmi compared to placebo in mercury intoxicated patients.

Eligibility criteria:
inclusion criteria 1. male or female subjects, age between 18 and 65 years, inclusive. 2. urine-hg ≥ 15 μg/l. 3. mercury intoxication medical score sum (doering et al. 2014) ≥ 5 or medical score sum ≥ 3 in combination with at least two of the following symptoms; social nervousness/withdrawal, irritability, memory loss, metallic taste, mental- and physical fatigue. 4. has signed informed consent for participation. 5. willingness and ability to comply with study procedures, visit schedules, and other instructions regarding the study. exclusion criteria 1. history of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subjects at risk because of participation in the study, or influence the results or the subject's ability to participate in the study. 2. known or a medical history of renal disorder, significant renal failure, or high risk of renal failure. 3. any clinically significant abnormalities in clinical chemistry or haematology results at the time of screening as judged by the investigator. 4. known or suspected neurodegenerative disorder including but not limited to stroke, polio, parkinson's and alzheimer's disease. 5. known or suspected drug or alcohol abuse. 6. positive pregnancy test in women. 7. serious bacterial and chronic viral infection such as human immunodeficiency virus (hiv) or hepatitis virus. 8. history of severe allergy/hypersensitivity or on-going allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to nbmi. 9. history of allergy/hypersensitivity to bisulphites (e.g. red/white wine). 10. participation in any other clinical study that included drug treatment within three months of the first administration of investigational product. 11. use of other therapies for mercury intoxication including metal chelators within three months. 12. investigator considers subject unlikely to comply with study procedures, restrictions and requirements.

Keywords: mercury toxicity poisoning