Kornimate/medical-research-clean huggingface dataset:
long-term extension study with eptinezumab as preventive treatment in participants with migraine in japan

Conditions: Migraine

Summary: this study is an open label extension study, which means that the participants from the lead-in study 19140a (nct04921384) can join this study, if they meet the study eligibility criteria, and continue to receive the study drug eptinezumab. the main goal of this study is to investigate long-term safety and tolerability of eptinezumab in japanese migraine participants.

the total study duration from the baseline visit to the safety follow-up visit is approximately 68 weeks and includes an open-label treatment period (60 weeks) and a safety follow-up period (8 weeks).

Eligibility criteria:
key inclusion criteria: * the participant has completed the primary outcome visit (visit 5) of the lead-in study 19140a immediately prior to enrolment into this study. * the participant is indicated for 60-week preventive treatment of chronic migraine with eptinezumab according to the clinical opinion of the investigator. key exclusion criteria: * the participant has a serious adverse event (sae) or a moderate or severe ongoing ae from the lead-in study considered a potential safety risk by the investigator. * the participant has a clinically relevant change in vital signs or electrocardiogram (ecg) from the lead-in study considered a potential safety risk by the investigator. * the participant has a disease or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability, or efficacy, or interfere with the conduct or interpretation of the study. other inclusion and exclusion criteria may apply.
the effect of listening to stories and watching cartoon film on pain in the aspiration process in children receiving palliative care

Conditions: Aspiration; Syndrome

Summary: the aim of this study is to determine the effect of listening to fairy tales and watching cartoons on pain in the aspiration process in play-age children receiving palliative care.

15 voluntary children with receiving palliative care, aged between 1-3 years will be randomly divided into two groups: fairy tale group and cartoon group. interventions will be applied for 3 weeks, 1 times a day (16 sessions). no intervention will be applied to both groups besides fairy tale or cartoon intervention. the children will be assessed before, during and after. pain due to aspiration procedure will be evaluated using the flacc pain scale. in addition, the heart rate, respiration, blood pressure, tidal volume and fever values of the children will be measured with the help of a bedside monitor.

Eligibility criteria:
inclusion criteria: * being in the 1-3 age group * being in the palliative care service for at least 3 months * receiving inpatient treatment in the pediatric palliative care service * absence of visual and hearing anomalies * no other chronic disease * having a tracheostomy exclusion criteria: * the family's desire to leave research. * deterioration of the child's condition * the child's diagnosis of an additional chronic disease

Keywords: palliative care children listening to stories watching cartoon film pain
nortriptyline for the treatment of functional dyspepsia

Conditions: Functional Dyspepsia

Summary: functional dyspepsia (fd) is a common functional gastrointestinal disorder characterized by upper abdominal discomfort/pain and/or symptoms of meal-related fullness/satiety. there is currently no definitive therapy that is beneficial for all fd patients. accumulating evidence suggests efficacy of tricyclic antidepressants (tcas) in fd. however, no firm conclusion can be drawn currently due to the relatively small amount of studies and large heterogeneity between studies. in addition, tcas are often associated with side effects, which occur early after initiation of therapy preceding the therapeutic effect and often result in discontinuation of the therapy. these side effects are related to drug metabolism, which depend on polymorphisms of the cytochrome p (cyp) enzyme system. it is therefore hypothesized that pre-treatment assessment of cyp genotype and subsequent exclusion of abnormal metabolizers limits the occurrence of side-effects and as such improves compliance and efficacy.


Eligibility criteria:
inclusion criteria: * age 18-65 years; * a diagnosis of fd according to the rome iv criteria; * predicted cyp2d6 extensive metabolizer phenotype on the basis of cyp genotyping * insufficient effect of first line treatment with proton pump inhibitors (twice daily) or prokinetics; * in the presence of alarm symptoms, patients are required to have undergone an upper gastrointestinal endoscopy (without evidence of organic disease), and have tested negative for helicobacter pylori 2 years prior to inclusion; * women in their fertile age (\<55 years old) must use contraception or be postmenopausal for at least two years. exclusion criteria: * predicted cyp2d6 poor, intermediate or ultrarapid metabolizer phenotype on the basis of cyp genotyping * evidence of current anxiety and/or depression disorder as defined by a score ≥ 10 on the gad-7 and/or phq-9 questionnaire; * current use or any previous use of psychotropic medication in the last 3 months prior to inclusion; * inability to discontinue prokinetics, nsaids or opioids; * using drugs of abuse; * using more than 2 or 3 units of alcohol per day (females and males respectively) * previous major abdominal surgery or radiotherapy interfering with gastrointestinal function: 1. uncomplicated appendectomy, cholecystectomy and hysterectomy allowed unless within the past 6 months; 2. other surgery upon judgment of the principle investigator; * history of gastric ulcer; * history of liver disease, cholangitis, achlorhydria, gallstones or other diseases of the gallbladder/biliary system; * history of epilepsy * history of glaucoma * pregnancy or lactation.
cytokines and genes in therapeutic response in crohn's disease

Conditions: Inflammatory Bowel Diseases

Summary: inflammatory bowel disease (ibd), consisting of two major forms, crohn's disease (cd) and ulcerative colitis (uc), affects more than 1.6 million people in the united states alone. though the precise mechanisms underlying the inflammation and immune responses in ibd are still being investigated, various inflammatory mediators, including pro-inflammatory cytokines, and genes have been implicated in the disease process. at present, there are no reliable mechanisms to predict response to individual ibd medications. the investigators seek to evaluate whether inflammatory cytokines change longitudinally during treatment with anti-cytokine agents in both treatment primary responders and primary non-responders. in addition, the investigators will be evaluating the pharmacogenetics of treatment response to these agents.


Eligibility criteria:
inclusion criteria: * patients that are seen in the inflammatory bowel disease clinic with crohn's disease who are initiating either treatment as part of their routine clinical care. * healthy adults without ibd undergoing colonoscopy for colorectal cancer screening or other non-ibd related indication. exclusion criteria: * pregnant * have a known coagulopathy or bleeding disorder * have known renal or hepatic impairment * have a history of organ transplantation * cd patients who are being seen in consultation and do not plan to receive longitudinal care through initiation their new therapy at the vanderbilt ibd center will be excluded.

Keywords: cytokines pharmacogenetics
impact of level iii support procedure on enlarged genital hiatus after minimally invasive sacrocolpopexy

Conditions: Pelvic Organ Prolapse

Summary: this is a randomized controlled surgical trial evaluating the use of a concomitant posterior colporrhaphy and/or perineorrhaphy at the conclusion of minimally invasive sacrocolpopexy to narrow enlarged genital hiatuses in a population of women with pelvic organ prolapse. the study's primary outcome is the proportion of women at 6 months postoperatively who still have an enlarged genital hiatus. an exploratory sub-aim (as of october 2021) of the study is to evaluate the levator hiatal area as compared with the genital hiatus by using preoperative and postoperative transperineal ultrasounds. subjects will be invited to participate, but is not required for study participation.


Eligibility criteria:
inclusion criteria: * female subjects with pelvic organ prolapse (pop) * planning a surgical repair of pop with minimally invasive sacrocolpopexy * preoperative resting genital hiatus measure between 4.0 and 7.5cm exclusion criteria: subjects who are unable to complete questionnaires or repeat office exams or if they do not otherwise meet inclusion criteria above \*note: we will not exclude patients based on prior surgical history (including prior posterior colporrhaphy)\*
dry needling treatment in hemiplegic shoulder pain

Conditions: Hemiplegia; Shoulder Pain; Myofascial Pain

Summary: to evaluate the efficacy of dry needling therapy on shoulder pain and upper extremity functions in hemiplegic patients.

the myofascial trigger point is an overlooked issue in hemiplegic shoulder pain. our aim in this study is to evaluate whether dry needling treatment contributes to the conventional treatment approach.

Eligibility criteria:
inclusion criteria: * the patients included in the study were aged between 30-60 years, with at least a 3-month history of hemorrhagic or ischemic stroke. exclusion criteria: * if they had severe difficulty in communication * had received a corticosteroid injection within 3 months prior to enrollment * had bleeding diathesis, a history of shoulder surgery * a preexisting painful shoulder disorder, or had a cardiac pacemaker.

Keywords: hemiplegic shoulder pain conventional treatment dry needling
family factors in young people with diabetes: a qualitative study

Conditions: Type 1 Diabetes

Summary: 8 young people (aged 12-15yrs) with type 1 diabetes will be interviewed along with their families during this qualitative study. the interviews will explore factors identified by the young people and their families as important in diabetes management. comparison of these factors will then be made between the young people with higher and lower hba1c levels.

family is an important factor in the self-management of type 1 diabetes by children and young people. existing research has explored the experience of living with diabetes, considered from the perspective of children and parents, but has not provided children's diabetes teams with the information they need to support young people with higher blood glucose levels, and therefore higher risks of long term complications related to their diabetes. during this qualitative study the researcher will meet with young people (aged 12-15yrs) and their families for a joint interview, held in the family home, exploring the factors which they consider important in diabetes self-management. one interview will be held with each family. recruitment of 8 families is planned. the interviews will be recorded and transcribed to allow thematic analysis, allowing identification of common factors considered to be important by families. the hba1c of young people with diabetes is checked regularly in clinic and provides an assessment of blood glucose levels over the preceding months. higher hba1c levels are associated with higher risk of long term complications. the index young people will be recruited in 2 groups: one group will have lower risk of long term complications (identified by an hba1c level of \<58mmol/mol). the other will have higher risk (hba1c 75-100mmol/mol). a comparison will be made between the families in each group, to identify which themes are more common in the lower or higher risk groups.

Eligibility criteria:
inclusion criteria: * age 12 - 15 years (between their 12th and 16th birthday at recruitment) * type 1 diabetes diagnosed for at least 6 months * group 1: hba1c \<58mmols/mol on last known test * group 2: hba1c ≥75mmols/mol and \<100mmols/mol on last known test * willing to participate in group interview with at least one parent/carer exclusion criteria: * family currently identified as not suitable for lone visits * participants with inadequate english to take part in a semi-structured interview conducted in english * children and young people for whom the last hba1c incongruent with their previous results will be excluded

Keywords: children and young people family qualitative
study of tb lesions obtained in therapeutical surgery

Conditions: Tuberculosis; Thoracic Surgery; Tuberculosis, Pulmonary; Tuberculosis, Multidrug-Resistant

Summary: the correlation of the morphologic, microbiological, genetic and histopathological characteristics of tb lesions obtained in therapeutical surgery with the clinical forms and features of the patients will provide essential information 1. on the role of the host in the mechanisms associated to the generation and evolution of active tb and 2. about future diagnostic and/or prognostic biomarkers of tb disease. all this information could be used for patients stratification and/or to design new therapeutic strategies.


Eligibility criteria:
inclusion criteria: * patients undergoing therapeutical surgery for their pulmonary tuberculosis at nctld in tbilisi, georgia indicated as per clinical routine exclusion criteria: * non consenting to donate samples and/or data for the study
a multicentre trial of second-line antiretroviral treatment strategies in african adults using atazanavir or lopinavir/ritonavir

Conditions: HIV

Summary: in the well recognized context of hiv infection chronicity, it is now crucial to identify and evaluate effective, well tolerated and affordable second line regimen in resources limited countries where patients often change treatment after a long period of viral replication while on first line regimen. this multicentre international, randomized, non-blinded phase iii trial aim to demonstrate the non-inferiority of a generic lamivudine-tenofovir-atazanavir/ritonavir regimen (daily intake) as compared to a standard emtricitabine-tenofovir-lopinavir/ritonavir (twice daily intake)regimen for second line hiv-1 treatment. by stratifying on the viral load level (between 1000 and 5000 copies/ml versus \> 5000 copies/ml) at inclusion, this trial will also allow to evaluate the optimum moment for instituting the second-line treatment.


Eligibility criteria:
inclusion criteria: * age 18 and above * out patient * documented hiv-1 infection * first line treatment failure: * after first-line antiretroviral treatment with a combination including a non-nucleoside reverse transcriptase inhibitor and two nucleoside reverse transcriptase inhibitors * two measurements of plasma hiv rna levels \> 1000 copies/ml after at least 6 months of uninterrupted treatment or without any major modification * satisfactory compliance (\>80%) to 1st line antiretroviral treatment * signed informed consent * agreement for contraception for women of childbearing age exclusion criteria: * hiv-2 infection or hiv-1/hiv-2 coinfection * uncontrolled, ongoing opportunistic infection or of any severe or progressive disease including active tb * first line antiretroviral treatment with a protease inhibitor or tenofovir * ongoing treatment with rifampicin * severe hepatic insufficiency (pt \< 50%) * alt \< 3 times the upper limit of normal * creatinine clearance calculated by cockcroft's formula \< 50 ml/min * hb \<=8 g/dl; platelets \< 50,000 cells/mm3; neutrophils \< 500 cells/mm3 * pregnancy and lactation

Keywords: hiv second line antiretroviral treatment sub saharian africa generic
exploratory prospective of experienced by patients in the surgery of skin cancers of the face in interventional dermatology department

Conditions: Skin Cancer Face; Surgical Incision

Summary: surgery is the first-line treatment of localized skin cancers. knowledge on the patient's psychological experience is limited. therefore, the psychological impact on patients before, during and after surgery can be underestimated. moreover, the diagnosis of cancer disturbs the patient's entire life and the onset of anxiety disorders is frequent following this announcement.

the main objective of the study is to explore patients' experience assessing anxiety before, during and away from surgery. the investigators will distinguish the anxiety related to the surgical act itself and the anxiety related to the announcement of the disease. the secondary objective is to assess the impact of surgery on quality of life, self-image and aesthetic satisfaction.

Eligibility criteria:
inclusion criteria: * patients ≥ 18 year-old * skin cancer on the face ((malignant lentigo, basal cell carcinoma and squamous cell carcinoma) for which a surgical treatment is proposed and will be performed in the dermatology unit of the university hospital (chu) de bordeaux * surgical procedure under local anesthesia * patient affiliated to health insurance * patients will sign consent after reading the information sheet explaining the objectives of the study. exclusion criteria: * patients not able to complete the self-assessment questionnaires (difficulties for understanding or reading) * patient for whom there was no pre-op consultation in the center * patient for whom follow-up will not be possible in the center (because of remoteness for example)

Keywords: surgical act- quality of life
proper dosage of ketamine in intravenous regional anesthesia

Conditions: Pain.

Summary: ketamine added to lidocaine can increase duration of pain relief following intraveonous regional anesthesia (ivra). the purpose of this dose response study is to determine the minimum effective dosage of intravenous ketamine, added to 3 mg/kg of lidocaine. we anticipate that one dosage will provide us with the proper balance between sufficient anesthesia and minimal side effects.


Eligibility criteria:
inclusion criteria: 1. age: 18-70 2. weight: 50-100 kg 3. asa: i, ii, iii 4. carpal tunnel syndrome surgery, tenolysis, ganglion removal or any peripheral hand surgery that can be done by ivra. exclusion criteria: 1. contraindication to ivra such as sickle cell disease. 2. any known hypersensitivity reaction to ketamine. 3. history of chronic pain or regular medication with analgesics. 4. history of opioid dependence. 5. drug of alcohol abuse. 6. psychiatric disorder. 7. allergy to acetaminophen or codeine
the effect of directional specific thoracic spine mobilization on cervical spine pain

Conditions: Neck Pain

Summary: hypothesis: there is no difference in directional specific manipulation of the thoracic spine for patients with neck pain. patients seeking physical therapy for neck pain routinely have their thoracic spine manipulated. this study seeks to determine if directional limitations in the spine can be specifically determined and treated to decrease neck pain.

manipulation of the thoracic spine is the most commonly used manual therapy intervention by manual therapists. it is not known whether we can accurately assess and treat directional limitations in the thoracic spine to improve neck pain. one way is to assess where the limitation is and treat it. another method is to distract the joint. we want to know if matching the limitation to the manipulation method will give patients with neck pain better results. the patient lays on their back. the therapist places a hand on the inferior vertebrae of the motion segment. the patient relaxes and the therapist pushes in an anterior to posterior direction either moving the vertebrae into flexion or entension.

Eligibility criteria:
inclusion criteria: * patients with neck pain; ages 18 - 60 exclusion criteria: * red flags: leg weakness, night pain, history of cancer, upper motor neuron signs, infection, tumors, osteoporosis, fracture (boissonnault, 2011) (cleland, 2004) history of whiplash within 6 weeks, cervical stenosis, cns involvement, signs consistent with nerve root compression, previous surgery, pending legal action
evaluation of the efficacy of an antioxidant dressing in chronic wound healing

Conditions: Hard-to-heal Wounds

Summary: the aim of this study is to compare the effect of antioxidant dressing (active product) on chronic wound healing with the use of non-active wound dressing for healing in a moist environment (standard clinical practice) in patients with hard-to-heal wounds


Eligibility criteria:
inclusion criteria: * patients over 18 years of age. * patients with leg ulcers (venous, ischemic, traumatic or diabetic foot ulcer). * patients with dehisced surgical wounds healing by second intention. * patients with pressure ulcers. * wound area between 1 and 250 cm2. exclusion criteria: * systemic inflammatory disease or oncological disease. * wounds with clinical signs of infection. * terminal situation (life expectancy less than 6 months). * ulcers from other etiologies: tumours, infectious. * wounds treated with negative pressure therapy. * pregnancy. * history of sensitivity or allergy to any of the components of the study dressing. in addition, criteria for withdrawal from the study will be considered: * worsening of the wound according to the clinical judgment of the professional (appearance of clinical signs of infection or others). * appearance of allergies or hypersensitivity to the dressing. * death. * hospital admission that interrupts or complicates the continuity of care in the nursing consultation. * transfer to another health district where there can be no continuity of care with the active dressing.

Keywords: chronic wound wound healing hard-to-heal wounds antioxidant dressing oxidative stress
direct swallowing training and oral sensorimotor stimulation in preterm infants

Conditions: Premature Birth of Newborn; Intervention Studies

Summary: this is randomized controlled trial investigating the effects of direct swallowing training and oral sensorimotor stimulation in preterm infants on oral feeding performance.


Eligibility criteria:
inclusion criteria: * preterm infants : before 32+0 weeks gestation * infants who are receiving full tube feeding (more than 120 ml/kg/day) * infants who discontinue of nasal continuous positive airway pressure before postmenstrual age 33+0 weeks * 'feeders and growers' * the parents of the subject voluntarily sign the informed consent exclusion criteria: * major congenital anomalies : face, central nervous system, gastrointestine, heart, etc * gastrointestinal complications * chronic medical complications : intraventricular hemorrhage ≥ grade iii, periventricular leukomalacia, surgical necrotizing enterocolitis

Keywords: infant, premature intervention studies bottle feeding