Kornimate/medical-research-clean huggingface dataset:
bougiecap for treatment of benign stenosis in gi tract

Conditions: Esophagostenosis

Summary: feasibility testing of a cap-assisted endoscopic bougienage for benign upper gi stenosis with direct optical control.

benign stenosis in the gi tract are endoscopically treated by using savary-gilliard dilators. this method, although sufficient in its interventional success, provides only haptic control and often requires wire guidance or x-ray imaging for monitoring the position of the stenosis, the dilator and the dilation process. to guarantee the missing optical feedback and enhance the intraprocedural control a conical, clear cap was developed. this single use device is attachable to the front end of an endoscope and provides direct visual evaluation of the mucosal damage and progress of the bougienage, making x-ray imaging obsolete while resulting in an effective dilation. for the bougienage treatment, the endoscope with the cap on top is inserted into the patient's gi tract and aimed at the stenosis. by pushing the endoscope forward the cone shaped cap expands the mucosal diameter by conversion of longitudinal to radial force vectors. lateral and frontal openings allow suction and flush during procedure. the clear tapering cap is now to be tested for ist technical feasibility and ability to improve patients' quality of life following treatment. therefore a quality of life questionnaire (swal qol) evaluating the patients' dysphagia is done right before and two weeks after the bougienage and an effective dilation is proved by being able to pass the stenosis with the endoscope after the treatment.

Eligibility criteria:
inclusion criteria: * benign stenosis of the esophagus * indication for endoscopic treamtent of stenosis exclusion criteria: * no informed consent * malignancy based stenosis * no indication for endoscopic treamtent

Keywords: esophagus stenosis bougienage
spinal muscular atrophy neonatal screening program

Conditions: Spinal Muscular Atrophy

Summary: spinal muscular atrophy (sma) is a group of disorders caused by the degeneration of the motor neuron cells of the anterior horn of the spinal cord and, in some subtypes, of the bulbar motor neurons. almost all cases are genetically determined. most smas are autosomal recessive diseases, caused by homozygous deletions of the survival motor neuron (smn) gene located on the long arm of chromosome 5. the estimated incidence of recessive childhood and juvenile sma linked to deletion of the smn gene is 1 in 6000 to 10000 live births, with a carrier frequency of 1 in 35 in the general population, making it a major genetic cause of infant mortality. up to 95-97% of all childhood cases are due to homozygous deletions of the survival motor neuron 1 (smn1) gene, or telomeric smn, located on chromosome 5q11.2-13.3. the remaining 3-5% of cases are due to small mutations in smn1 (rather than complete deletions). until a few years ago, the prognosis of type 1 sma was poor. in the absence of therapies, the only measures were supportive (ventilation, nutrition) and the prospect, especially in the early forms, was to accompany them towards an early end of life. there are currently three treatment options available: nusinersen, risdiplam, and gene therapy with onasemnogene abeparvovec. the three options were found to be equally effective in reducing the symptoms of the disease, making it possible to reach or safeguard fundamental stages in a child's neuromotor development, starting from the ability to remain seated. at this moment, gene therapy is probably the preferred choice. to date, in italy, there are approximately 100 patients undergoing gene therapy. to ensure maximum benefit for affected patients, it is essential that the therapy is administered as soon as possible. literature shows how the administration of gene therapy in pre-symptomatic subjects made it possible to achieve a better neurological outcome compared to symptomatic patients. from this perspective, the inclusion of spinal muscular atrophy in neonatal screening is of fundamental relevance.


Eligibility criteria:
inclusion criteria • live births in the neonatologies and paediatric centers involved in the study. exclusion criteria • no consent signed by parents.

Keywords: spinal muscular atrophy newborn screening
litfulo capsules special investigation

Conditions: Alopecia Areata

Summary: the objective of this study is to confirm the safety during the long-term use of this drug and the effectiveness during the use of this drug under the actual use in the patients treated with this drug.

this study is an open-label, multi-center, one arm prospective observational cohort study of patients receiving this drug. the investigators complete the crf based on the information extracted from the medical record created in daily medical practice.

Eligibility criteria:
inclusion criteria: patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: * patients with alopecia areata who start receiving this drug for the first time after the contract date of this study * patients who have not participated in a clinical trial (clinical study) of this drug exclusion criteria: patients meeting any of the following criteria will not be included in the study: * patients previously enrolled in this study * patients with a history of treatment with this drug (including investigational product)
pelvic drain after rectal resection for mid-low rectal cancer

Conditions: Rectal Cancer

Summary: this rct aims at assessing the effects of a pelvic drain after total mesorectal excision for mid-low rectal cancer on the rates of pelvic sepsis and anastomotic leaks.

this is a 2-arm, non-inferiority rct. patients undergoing total mesorectal excision for mid-low rectal cancer will be randomly assigned into two groups: * pelvic drain * no pelvic drain. patients will be followed-up to assess the rates of anastomotic leaks, pelvic sepsis and secondary outcomes.

Eligibility criteria:
inclusion criteria: * male or female, 18 year-of-age or above * mid or low rectal cancer * anastomosis below the peritoneal reflection * total mesorectal excision (tme) * capability to understand the study * informed consent exclusion criteria: * for women, pregnancy * chronic kidney failure or hepatic failure, immunodepression, malnoutrition * life expectancy \< 6 months * partial mesorectal excision * abdominoperineal excision * multivisceral resections * emergency surgery
sleep apnea syndrome on acromegaly: impact of the treatment on the carbohydrates metabolism.

Conditions: Acromegaly; Obstructive Sleep Apnea; Insulin Resistance

Summary: sleep apnea is a common situation that affects up to 80% of acromegalic patients. this disease is linked to disturbance on the carbohydrate metabolism increasing the rates of diabetes. the objective of this trial is to assess (with the euglycemic hyperinsulinemic clamp) the impact of the treatment of sleep apnea, with a continuous positive air pressure device (cpap), on the insulin resistance.


Eligibility criteria:
inclusion criteria: * acromegalic patients * moderate to severe sleep apnea * using somatostatin analogues at maximum dosage possible for at least 6 month exclusion criteria: * unstable angina or high risk for stroke * hepatic or renal insufficiency * uncontrolled diabetes * seizures * steroids use * uncontrolled hormonal deficiencies

Keywords: acromegaly insulin resistance euglycemic clamp somatostatin analogues
utilizing topical sodium hypochlorite to ameliorate radiation dermatitis

Conditions: Radiation Dermatitis

Summary: the objective of the pilot study is to determine compliance, acceptability, and feasibility of using topical sodium hypochlorite to ameliorate or reduce radiation dermatitis, and to collect preliminary data and estimates for planning a larger efficacy study. this 3-week single-arm pilot study will collect information on subject treatment compliance and feedback from subjects (and nurses/subject's treating oncologist) on the acceptability of the use of the treatment. we will also collect data on common terminology criteria for adverse events and patient reported outcomes measured using the pain and pruritus promis short-form tools and patient reported outcomes, measured using the dermatology life quality index (dlqi) tool.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * been diagnosed with head and neck cancer requiring radiation therapy or skin cancer requiring radiation treatment to the neck * are scheduled for a radiation therapy planning session (ct simulation) * have a scheduled radiation therapy start date within 1 to 2 weeks from the ct simulation * are able to comply with the study protocol exclusion criteria: * patients who are pregnant, which may lead to discontinuation of radiation therapy * patients currently on immunotherapy * active or past history of inflammatory lesions in the radiation field that could interfere with assessment * patients who are undergoing re-irradiation to the head and neck * patients must not have any other condition or situation beyond those listed above which, in the investigator's opinion, puts the patient at significant risk, could confound the study results, or may interfere significantly with the patient's participation in the study. * patients who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function are not eligible. * participation in other clinical trials that would alter the radiation dose typically utilized for definitive chemo and radiation therapy treatment of head and neck cancer. * use of other topical treatments on the skin in the treatment field. no other products are allowed except aquaphor® ointment.
mesh-free suture urethropexy for treating stress urinary incontinence, efficacy and durability trial

Conditions: Stress Urinary Incontinence

Summary: in this proposed study, the investigators aim to evaluate a modified suture urethropexy technique for the treatment of female stress urinary incontinence. participants will be followed with postoperative visits after 2 weeks, 2 months, and 12 months. pelvic floor ultrasound imaging will be performed before surgery and after 2 months and 12 months, to evaluate urethral mobility.

this study is designed as a prospective observational study. the hypothesis is that suture urethropexy will improve stress urinary incontinence symptoms in participants with stress urinary incontinence and normal urethral closure pressure at 2 months and 12 months after surgery. specific aims: aim 1: investigate the efficacy of this mesh-free suture based surgical technique for improving sui symptoms aim 2: investigate the efficacy of this mesh-free suture based surgical technique on key urethral support defects observed with 3d ultrasound

Eligibility criteria:
inclusion criteria: * 18 years or older with stress dominant urinary incontinence * stress urinary incontinence confirmed by testing (e.g. urodynamics) * able to provide informed consent and attend post-operative visits exclusion criteria: * detrusor overactivity (\> 40cm h2o) * maximum urethral closure pressure (\< 40 cm h2o) * post void residual \> 150 ml * prior surgery for stress urinary incontinence with retained material (e.g. bulking agent, sling)
efficacy of the nanodropper device on pupillary dilation

Conditions: Dilation

Summary: prescription eye drop bottles elute drops that exceed the capacity of the human eye by five times. this study describes performing in clinic dilation using a novel solution for combating medical waste with nanodropper, an eye drop bottle adapter that creates smaller eye drops.


Eligibility criteria:
inclusion criteria: * participants under the age of 18 years old exclusion criteria: * participants 18 years and older * pupillary or anterior segment abnormality * participants with pre-existing health conditions that would prevent pupillary dilation.
development of an empowerment intervention for young women living with hiv

Conditions: HIV

Summary: this study will develop/adapt a culturally appropriate secondary prevention intervention for young, human immunodeficiency virus (hiv)-positive women through intervention groups, evaluate its acceptability and feasibility, make appropriate modifications, and manualize the intervention in preparation for a full-scale randomized trial. once the intervention is developed/adapted, the sites will pilot the interventions twice to enable modifications. the intervention aims to address the following concerns: 1) reducing the risk of young women infected with hiv transmitting the virus to their sexual partners, and 2) preventing young women infected with hiv from re-infection with a new viral strain or co-infection with another sexually transmitted disease (std). data will be collected to assess the feasibility and acceptability of the newly developed intervention using both quantitative and qualitative methods at each iteration.


Eligibility criteria:
inclusion criteria: * female at birth and currently female; * receives services at one of the selected atn sites or their community partners * hiv-infected as documented by medical record review or verbal verification with referring professional * between the ages of 16-24 years (inclusive) at the time of informed consent/assent * ability to understand both written and spoken english * gives informed consent/assent for study participation exclusion criteria: * presence of active, serious psychiatric symptoms (e.g., hallucinations, thought disorder) that would impair a participant's ability to meet the study requirements * visibly distraught (e.g., suicidal, homicidal, exhibiting violent behavior) * intoxicated or under the influence of alcohol or other substances at the time of study enrollment\*. * intoxication at the time of visit will exclude participation at that time. participants cannot be visibly under the influence of substances at the time of enrollment or consent. if a participant returns to enroll while sober, enrollment can occur. similarly, if a participant arrives to an intervention group visibly intoxicated, then she will be asked to leave. however, prior intoxication does not eliminate future participation. thus, those who are dismissed from a session due to intoxication can return to a subsequent session as long as they are sober.

Keywords: hiv adolescent trials network
a study of elnd002 in patients with relapsing forms of multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to evaluate the long-term safety and tolerability of elnd002 in patients with multiple sclerosis (ms) after participation in study ms103.


Eligibility criteria:
inclusion criteria: * this study is open only to subjects who have completed the week 12 visit in study elnd002-ms103 while taking their assigned dose of study drug. exclusion criteria: * subject has no new medical contraindications to continue participation in the study.

Keywords: relapsing forms of secondary progressive multiple sclerosis (spms)or relapsing-remitting multiple sclerosis (rrms)
hearing loss and complaint in patients with head and neck cancer treated with radiotherapy

Conditions: Hearing Loss

Summary: hypothesis: treatment for head and neck tumors often involve methods that affect the auditory system and cause hearing loss. neck dissection negatively impacts the lymphatic drainage, chemotherapy uses ototoxic drugs, radiotherapy affects blood flow and tissue radiation is toxic to the ear and may lead to hearing losses of various types and degrees. objective: to investigate occurrences of hearing loss and complaints among patients with head and neck tumors who underwent radiotherapy. study design: prospective, case-control study. setting: tertiary care center hospital. subjects and methods: 282 subjects were evaluated, 141 with head and neck tumors and 141 as an age-matched control group. the controls had never undergone oncological treatment that put their hearing at risk. all subjects underwent audiological evaluation, including the hhie questionnaire, pure tone audiometry, speech audiometry and immittance audiometry. the radiation dose received by the auditory system was calculated based on the percentage of the external auditory canal included in the radiation field.


Eligibility criteria:
inclusion criteria: * the group of exposed individuals * had to be patients with disease-free survival interval of at least two years subsequent to treatment for head and neck cancer * radiotherapy alone or in combination, in which the auditory system was included in the field of irradiation. * the group of non-exposed individuals (control group) * had to be patients who had not undergone oncological treatment that put their hearing at risk * age-matched (2 years). this group was formed by individuals who had had pelvic tumors or skin tumors and who had only undergone local surgery to remove their tumors, and by female volunteers from the hospital. * all of these individuals were asked whether they would be willing to participate in a study, without knowing in advance whether they had any previous hearing problems or complaints. exclusion criteria: * congenital hearing loss * otological surgery

Keywords: hearing loss head and neck cancer radiotherapy hearing complaint hearing loss due to the exposure of radiotherapy
a study investigating the long-term safety and efficacy of deferiprone in patients with friedreich's ataxia

Conditions: Friedreich's Ataxia

Summary: the primary objective of this study is to evaluate the long-term safety and tolerability of deferiprone in subjects with friedreich's ataxia (frda). the secondary objective is to evaluate the long-term efficacy of deferiprone for the treatment of frda. the tertiary objectives are to evaluate the effect of deferiprone on: 1. cardiac function, 2. quality of life, and 3. functional status.

this is a multi-centre, open-label, non-randomized, single treatment, safety and efficacy study. all subjects who completed the la29-0207 study are eligible for participation. participants will receive deferiprone oral solution at the same dose (20 or 40 mg/kg/day) that they were assigned for la29-0207. the duration of treatment will be 52 weeks.

Eligibility criteria:
inclusion criteria: 1. subjects who completed the apopharma study la29-0207 2. female subjects of childbearing potential must have a negative pregnancy test. 3. male subjects must confirm that he and/or his female partner will use an effective method of contraception for the length of the trial and for 30 days following completion of the study or early termination. 4. signed and witnessed written informed consent/assent, obtained prior to the first study intervention, as well as the ability to adhere to study restrictions, appointments and evaluation schedules. exclusion criteria: 1. serum ferritin and hemoglobin (hb) levels are below the reference range for age and sex-matched controls. 2. unable to complete t25fw and with a score \> 5 minutes in the 9hpt. subjects who can complete t25fw or with a score ≤ 5 minutes in the 9hpt will be allowed to enrol). 3. doubling of score on 9hpt or t25fw compared to their study baseline results in la29-0207. 4. history or evidence of neutropenia/agranulocytosis defined by a confirmed absolute neutrophil count (anc) \< 1.5 x 109/l or thrombocytopenia defined by a platelet count \<150 x 109/l. 5. occurrence of saes or any other aes during the la29-0207 study, which in the opinion of the investigator cause the patient's participation in the extension study to be inappropriate. 6. unable to comply with requirements of the protocol. 7. pregnant, breastfeeding or planning to become pregnant during the study period. 8. qtc interval \>450ms. 9. have been on antioxidants prior to start of study treatment.

Keywords: friedreich's ataxia
the effects of intake of protein from cod fillet and cod residual material on lipid regulation, glucose regulation and inflammation in overweight or obese adults.

Conditions: Overweight and Obesity; Healthy

Summary: a high intake of fish is associated with positive health effects, including prevention and treatment of chronic non-communicable diseases, such as cardiovascular diseases (cvds) and type 2 diabetes. these health effects have traditionally been attributed to the omega-3 fatty acids in fatty fish, but recent studies have suggested that also fish proteins may improve biomarkers of metabolic disease. intake of cod fillet have previously shown beneficial effects on blood lipids, glucose regulation and body composition in adults with overweight or obesity. health effect of cod residual material from fillet production (i.e., head, backbone, skin, cutoffs and entrails) have so far not been investigated, but residuals from other fish species have shown promising effects on glucose regulation in rats. the main aim of the current study is to investigate the effects of protein from cod fillet and cod residuals on serum lipids, glucose regulation and inflammatory markers in healthy overweight or obese adults.


Eligibility criteria:
inclusion criteria: * bmi ≥ 27 kg/m2 * fasting blood glucose ≤7 mmol/l * physically inactive * percent body fat \> 25 % for men and \> 35 % for women exclusion criteria: * allergies towards fish, milk, egg, gluten * tobacco use \> 10 cigarettes (or snus) per day * diseases affecting the heart, intestinal function, kidney function or insulin secretion * medications targeting cholesterol -or glucose metabolism, hypertension * use of dietary supplements * pregnancy or lactation
assessing associations between ibs symptoms, nutrition and qol in ibs patients using a questionnaire

Conditions: Irritable Bowel Syndrome

Summary: this study is a cross-sectional observational study design that aimed to include 2000 ibs patients. we used several validated questionnaires, to assess ibs characteristics (such as subtype, severity), psychological features (qol, anxiety and depression) and assess nutritional triggers. subjects filled in the questionnaire online, and was spread across the netherlands.


Eligibility criteria:
inclusion criteria: * ibs-like symptoms exclusion criteria: * younger than 18 years

Keywords: nutrition irritable bowel syndrome quality of life
oxycodone for labor pain - pharmacokinetics (pk), safety and efficacy

Conditions: Labor Pain

Summary: childbirth is one of the most painful events that a woman is likely to experience, and thus is a major concern for most parturient. severe pain releases stress mediators and may thus compromise fetus well-being if placental perfusion is decreased. epidural analgesia is the golden standard for the management of severe labor pain. however, it could not always be used both due the parturient related factors and the organizational reasons.however, the knowledge on safety and efficacy of oxycodone involving mother, fetus and newborn is limited. aim of the study is firstly, to evaluate the efficacy and safety of oxycodone in labor pain healthy parturients. secondly, to measure parturient's blood oxycodone concentration during labour and fetal concentration from placental umbilical vein and artery right after birth.


Eligibility criteria:
inclusion criteria: * labouring healthy women * early labour * age 18-45 years exclusion criteria: * sleep apnea or other central deficit affecting breathing * pulmonary insufficiency * liver of kidney insufficiency * use of mono amine oxidase medication * thyroid, pituitary insufficiency * paralytic ileus * other contraindication specified by the investigator

Keywords: oxycodone labour pain pregnancy pregnant women