Kornimate/medical-research-clean huggingface dataset:
an evaluation of dupilumab in patients with nasal polyposis and chronic symptoms of sinusitis

Conditions: Nasal Polyps

Summary: primary objective: to evaluate the efficacy of dupilumab (sar231893/regn668) in the treatment of bilateral nasal polyposis (np) by assessment of the endoscopic nasal polyp score (nps) in comparison to placebo. secondary objectives: to evaluate effect of dupilumab with regards to: * symptoms of sinusitis, * sinus computed tomography (ct) scan, * nps in the sub-group of participants with co-morbid asthma, * safety and tolerability.

screening period (4 weeks) + randomized treatment period (16 weeks) + post-treatment period (16 weeks) = 36 weeks. to ensure at least 28 participants with co-morbid asthma needed for subgroup analysis, recruitment of np participants without co-morbid asthma would stop when approximately 28 participants without asthma were randomized.

Eligibility criteria:
inclusion criteria: participants with: * a minimum bilateral nasal polyp score of 5 out of a maximum score of 8 (with a unilateral score of at least 2 for each nostril) despite completion of a prior intranasal corticosteroid (incs) treatment for at least 8 weeks before screening. * presence of at least two of the following symptoms prior to screening: nasal blockade/obstruction/congestion or nasal discharge (anterior/posterior nasal drip); facial pain/pressure; reduction or loss of smell. exclusion criteria: * participants \ 65 years of age. * sinonasal outcome test (snot-22) \<7. * participants who had taken other investigational drugs or prohibited therapy for this study within 2 months before screening or 5 half-lives, whichever was longer: * burst of systemic corticosteroids within the 2 months before screening or were scheduled to receive systemic corticosteroids during the study period for another condition * incs drops within 1 month prior to screening * monoclonal antibody (mab) and immunosuppressive treatment * anti-immunoglobulin e (ige) therapy (omalizumab) within 130 days of visit 1 * leukotriene antagonists/modifiers unless participant was on a continuous treatment for at least 30 days prior to visit 1. * participants who had undergone any nasal surgery (including polypectomy) within 6 months before screening or have had more than 5 sinonasal surgeries in the past of which maximal 2 were surgeries changing the lateral wall structure of the nose. * participants with asthma having: * forced expiratory volume (fev1) ≤ 60%, or .asthma exacerbation requiring systemic (oral and/or parenteral) steroid treatment or hospitalization for \>24 hours for treatment of asthma, within 3 months prior to screening or were on a dose of greater than 1000 microgram (mcg) fluticasone or an equivalent incs. the above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
a trial comparing qam with qpm dosing in assisted reproductive technologies (art)

Conditions: Infertility

Summary: this is a prospective randomized trial comparing the outcome in women undergoing ivf/icsi when taking their gonadotropin dosage in the morning (am) or evening (pm).


Eligibility criteria:
inclusion criteria: * women between 21-42 undergoing ivf exclusion criteria: * women \> 45, * women with one ovary, * donor egg, * surrogacy, * fet cycles, * uterine problems, * large fibroids

Keywords: ivf icsi gonadotropin am dose pm dose pregnancy implantation live birth
a trial investigating safety and efficacy of treatment with bay94-9027 in severe hemophilia a

Conditions: Hemophilia A

Summary: haemophilia a is an inherited disorder in which one of the proteins, factor viii, needed to form blood clots is missing or not present in sufficient levels. in a person with haemophilia a, the clotting process is slowed and the person experiences bleeds that can result in serious problems and potential disability. the current standard treatment for severe haemophilia a is regularly scheduled infusion of fviii to keep levels high enough to prevent bleeding. due to the short half-life of fviii, prophylaxis may require treatment as often as every other day. in this trial safety and efficacy of a long-acting recombinant factor viii molecule is evaluated in subjects with severe hemophilia a. 120-140 patients will receive open label treatment with long-acting rfviii either on-demand to treat bleeds or prophylactically for 36 weeks in the main trial plus an optional extension to continue treatment for at least 100 total exposure days (ed). patients on prophylactic treatment will receive study drug at dosing intervals between once and twice a week depending on their observed bleeding. patients will attend the treatment centre for routine blood samples and be required to keep an electronic diary. male patients aged 12-65, with severe hemophilia a, previously treated with fviii for at least 50 exposure days may be eligible for this study.

subjects in prophylactic treatment arms will undergo clinical evaluation at 10 weeks. those with adequate control of bleeding will undergo randomization to every 5 or 7 day infusion. those with continued bleeding will remain in treatment arm and have an increase in dose. part b-major surgery - optional sub study included to collect information on efficacy of bay94-9027 in major surgical setting. due to rarity of surgery in this population, enrollment to this sub-study may be independent of participation in main study.

Eligibility criteria:
inclusion criteria: * male; 12-65 years of age * subjects with severe hemophilia a * previously treated with factor viii for a minimum of 150 exposure days exclusion criteria: * inhibitors to fviii (current evidence or history) * any other inherited or acquired bleeding disorder in addition to hemophilia a * platelet count \< 100,000/mm3 * creatinine \> 2x upper limit of normal or ast/alt (aspartate aminotransferase/alanine aminotransferase) \> 5x upper limit of normal

Keywords: hemophilia a, factor viii, prophylaxis
'long covid-19' in suffolk and north essex: defining the disease and optimising outcomes

Conditions: Covid19

Summary: to accurately describe the rehabilitation needs of individuals with post-covid-19 syndrome up to 36 months after infection, allowing better diagnosis, triage and resource management. a major focus will be the impact on everyday life to return to normal activities.


Eligibility criteria:
inclusion criteria individuals 18 years old and over (no upper age limit) female and male diagnosed with covid-19 via pcr testing or, experienced symptoms of covid-19 (new continuous cough, a high temperature, loss of taste and smell) and clinically diagnosed with post-covid-19 syndrome by their gp participants who live within suffolk and north east essex exclusion criteria individuals unable to consent for themselves individuals without sufficient proficiency in english language to take part in telephone or video call, where the research team have been unable to make adjustments to enable their participation individuals under 18 years old
deficits in emotion regulation skills as a maintaining factor in binge eating disorder

Conditions: Binge-Eating Disorder

Summary: the effectiveness of a systematic affect regulation training (art; berking, 2010) is evaluated with regard to reducing symptoms of binge eating disoder in a randomized controlled trial.

evidence suggests that deficits in affect regulation play an important role in the development and maintenance of binge eating disorder (bed). thus, we aim to clarify whether bed symptoms can be reduced with the help of a training of general affect regulation skills. for this purpose, we randomly allocated n = 99 individuals meeting criteria for bed either to an affect regulation training (art) or to a wait list control condition (wlc). primary outcome is the reduction of binges during the treatment-vs.-waiting period as assessed with the eating disorder examination (ede) interview. secondary outcomes include bed symptom severity at follow-up and change in emotion regulation skills. to clarify whether potential differences between groups regarding change in binge eating result from a greater increase of affect regulation skills in art, we will test whether potential group differences regarding binges will be mediated by differences between groups regarding change in affect regulation skills. change of randomization procedure: over the course of the study, serious difficulties occurred with regard to recruiting participants as quickly as necessary to avoid drop-outs due to participants' unwillingness to wait until eight individuals were recruited for randomization. to solve the problem, we switched from the original block randomization to a procedure in which the next patient eligible for the study was allocated to the treatment condition until the minimum group size of four was reached.

Eligibility criteria:
inclusion criteria: * diagnosis of bed according to dsm-5 criteria * age over 18 and below 69 * 25 \< bmi \< 45 * ability and willingness to provide informed consent exclusion criteria: * high risk of suicide * co-occurring psychotic, bipolar disorders, alcohol/substance dependence within the past six months and/or borderline personality disorder * medical disorders that would affect weight and/or the ability to participate * insufficient german language skills (as assessments and treatment were conducted in german) * current participation in psychotherapeutic treatment other than those offered in the study * current participation in a weight control program * taking medication that would affect weight * pregnancy.

Keywords: binge-eating disorder affect regulation training emotion regulation transdiagnostic
the early administration of sodium thiosulfate should help to reduce the mortality of dialysis patients with calciphylaxis, from a national cohort

Conditions: Calciphylaxis; Renal Insufficiency, Chronic

Summary: the national drug safety agency authorizes nominatively the use of sodium thiosulfate in dialysis patients with calciphylaxis. to date, it is the largest global cohort (more 600 patients from 2012 to 2016). we wanted to study retrospectively the fate of these patients at 6 months including mortality. early use improves effectiveness.


Eligibility criteria:
inclusion criteria: * all dialysis patients with calciphylaxis in france who have obtained a temporary use authorization for sodium thiosulfate by national agency for the safety of medicines exclusion criteria: * n/a

Keywords: calciphylaxis/complications kidney failure, chronic/complications renal dialysis thiosulfates/therapeutic use time factors
efficacy and safety of kinesiology tape wrapping for paronychia induced by epidermal growth factor receptor inhibitors

Conditions: Paronychia; Epidermal Growth Factor Receptor Inhibitor

Summary: epidermal growth factor receptor inhibitors(egfris) have been applied in several common malignancies including advanced non-small cell lung cancer. paronychia is one of the most common cutaneous side effects, characterized by inflamed granulation tissue around the nails leading to pain and reduced quality of life. despite available conventional therapies such as topical beta-blockers or chemical cauterization, some patients still do not respond well. our previous pilot study suggested that adding kinesiology tape wrapping to the conventional treatment may effectively improve pain and granulomas in patients with treatment-resistant egfri-related paronychia, with good safety. this study aims to evaluate the clinical efficacy and safety of using kinesiology tape wrapping as an adjunct to conventional therapy for patients with egfri-related paronychia.

in this study, eligible patients with paronychia affecting their big toes will be included and randomized to receive a combination of kinesiology tape wrapping and conventional treatment, or conventional treatment alone for 3 months. patients are evaluated at baseline, at 1, 2, 4, 8, and 12 weeks after the initiation of the treatment. these evaluations will occur at the outpatient department or through phone contact and photos taken by patients if they cannot visit in person. efficacy endpoints include pain numerical rating scale (nrs) and scoring system for paronychia related to oncologic treatments (spot). besides, any side effects will be recorded at each visit.

Eligibility criteria:
inclusion criteria: * egfr inhibitors-induced paronychia * having at least one big toe involved with ctcae(common terminology criteria for adverse events) grade 2-3 paronychia exclusion criteria: * younger than 20 years * severe ingrown nails * concomitant cutaneous infection * severe nail destruction * chronic paronychia with severe periungual fibrosis
percutaneous tenotomy of the toe flexor tendon is a simple and efficient method in treating checkrein deformity

Conditions: Claw Toe

Summary: checkrein deformity represents a dynamic claw toe deformity. surgical intervention is the treatment of choice and many methods have been proposed. the purpose of this study is to evaluate the outcomes and complications of percutaneous segmental tenotomy of the toe flexor tendons.

the investigators reviewed fourteen patients with checkrein deformity who underwent surgery in our hospital between 1993 and 2010. five patients received fhl and flexor digitorum longus (fdl) tenolysis at the musculotendinous junction; among them, two also underwent z-plasty lengthening of the fhl tendon. nine patients underwent percutaneous segmental toe flexor tenotomy. the hallux metatarsophalangeal- interphalangeal scale (hallux mtp-ip scale) and foot and ankle outcome score (faos), english version lk1.0 self-explanatory questionnaire were used to evaluate the functional outcomes.

Eligibility criteria:
inclusion criteria: * patients with checkrein deformity who underwent surgery in our hospital between 1993 and 2010. exclusion criteria: * patients who had static or rigid claw toe deformity * patients who had claw toe deformity secondary to neuromuscular disease

Keywords: claw toe
pecs block for pacemaker insertion in children

Conditions: Complete Heart Block

Summary: evaluation of ultrasound guided modified pectoral nerves blocks in transvenous subpectoral pacemaker insertion in children: randomized controlled trial

background pectoral nerve blocks (pecs) can reduce intraprocedural anesthetic requirements and postoperative pain. little is known about the utility of pecs in reducing pain and narcotic use after pacemaker (pm)placement in children. objective the purpose of this study was to determine whether pecs can decrease postoperative pain and opioid use after pm placement in children. methods a single-center controlled trial of pediatric patients undergoing transvenous pm placement between 2020 and 2021 will be performed. demographics, procedural variables, postoperative pain, and postoperative opioid usage will be compared between patients who undergone pecs and those who undergone conventional anesthetic (control).

Eligibility criteria:
inclusion criteria: * congenital or post-operative heart block. exclusion criteria: * ⦁ redo patient * history of allergic reactions to local anesthetics. * bleeding disorders with international normalization ratio( inr) \> 1.5 and/or platelets \< 50 000. * rash or signs of infection at the injection site. * emergency procedure
feasibility of intermittent fasting during chemotherapy

Conditions: Lymphoma; Cancer; Fasting

Summary: the goal of this randomized controlled parallel group trial is to examine if fasting before and after chemotherapy is safe, feasible and acceptable. the study population will include patients with either hodgkin lymphoma or diffuse large b cell lymphoma. the main questions aimed to answer are: whether fasting during chemotherapy is safe for patients, whether it is feasible to implement in a clinical setting, and whether patients find it acceptable. we also want to examine a number of patient-reported outcome measures regarding health status and quality of life, such as dietary intake and adverse events from chemotherapy. researchers will compare fasting to standard treatment. participants will: * fast 24 hours before and 24 hours after chemotherapy in addition to standard treatment or receive only standard treatment * keep a diary of their dietary intake 24 hours before and 24 hours after chemotherapy * keep a diary of their dietary intake for three consecutive days between chemotherapy cycles * answer questionnaires/questions in relation to side effects from fasting, side effects/adverse events of chemotherapy, quality of life * take bioimpedance analysis (including body mass index and body composition) * take blood- and feces samples


Eligibility criteria:
inclusion criteria: * patients diagnosed with diffuse large b-cell lymphoma planned to receive r-chop (rituximab, vincristine, doxorubicin, cyclophosphamide, and prednisolone) and hodgkin lymphoma receiving abvd (doxorubicin, bleomycin, vinblastine and dacarbazine) * age ≥ 18 years * ecog status 0-2 * normal weight and overweight (bmi ≥ 18,5 kg/m\^2) exclusion criteria: * receiving concurrent radiation therapy and/or treatment * other concomitant disease that may make intermittent fasting complicated such as diabetes mellitus * ecog status: \> 3 * bmi \< 18,5 kg/m2 * age \> 80 years

Keywords: chemotherapeutic toxicity chemotherapy adverse effect short-term fasting feasibility studies fasting
voice changes during ect

Conditions: Unipolar Depression; Bipolar Depression; Bipolar Disorder, Manic

Summary: depressed patients talk differently when they are depressed compared to when they are well. but it is hard to actually measure what the differences are. the study team will record voice samples from patients with mood disturbances, like depression, over the course of their receiving an electroconvulsive therapy (ect) series. the study team will try and measure or quantify exactly what has changed in their speech and voice. the study team will choose ect as it is one of the most effective and rapid treatment for depression. the study team will use a service provided by a company, neurolex, who has complex computer programs (artificial intelligence, ai) to analyze the voice samples.


Eligibility criteria:
inclusion criteria: * any candidate for electroconvulsive therapy who is about to initiate their ect course at medical university of south carolina (musc) for a clinically indicated diagnosis * age 18 to 90 years old * able to speak and understand english * able to give consent to participate in the study exclusion criteria: * any medical condition that limits the ability to speak or speak clearly, for example a history of head and/or neck cancer, spinal cord injury affecting speech, amyotrophic lateral sclerosis, or those with absence of critical anatomical structures involved in speech. * any voice characteristics that may limit the ability to speak english clearly including speech impediments or heavy accents (as evidenced by the pronunciation of the english language in such a non-standard way that research staff). if study staff have significant difficulty understanding the participant's responses in conversation, this may warrant exclusion. * patients who are receiving ect by involuntary order, by order of their guardian, or by a court order, as evidenced by patient report or brief chart review. * patients who elect to not receive their full course of ect at musc.

Keywords: vapre
camrelizumab combined with famitinib malate for treatment of recurrent/metastatic cervical cancer

Conditions: Cervical Cancer

Summary: this study is a randomized, open-label, controlled, multi-center phase iii clinical study, aimed to evaluate the efficacy and safety of camrelizumab combined with famitinib malate versus platinum-based chemotherapy in the treatment of recurrent/metastatic cervical cancer. all enrolled patients will be randomly divided into 2 groups and continuously treated until any event that meets the criteria for end of the clinical trial.


Eligibility criteria:
inclusion criteria: 1. female aged 18-75 years (including 18 and 75 years, calculated based on the signing date of the informed consent) 2. histopathologically confirmed recurrent/metastatic cervical squamous cell carcinoma that cannot be radically treated by surgery, radiotherapy or chemoradiotherapy 3. no prior systemic anti-cancer therapy for recurrent/metastatic disease 4. according to recist v1.1 criteria, the patient must have at least one measurable lesion 5. able to normally swallow drug tablets 6. the organ function level is good 7. willing to participate and able to comply with research programme requirements exclusion criteria: 1. has any malignancy \<5 years prior to study entry. 2. known to have brain or meningeal metastasis 3. known to have autoimmune disease 4. received live vaccinations 4 weeks before randomization or during the study period
a clinical trial to assess three different doses of ops-2071 in patients with bacterial enteritis

Conditions: Bacterial Enteritis

Summary: to assess safety, efficacy and pharmacokinetics of multiple dosesin patients with bacterial enteritis caused by clostridium difficile infection(cdi) or enteric infection.


Eligibility criteria:
inclusion criteria: * the patient provides written, informed consent before the clinical trial is initiated * the patient has distinctive symptoms and findings of bacterial enteritis * the patient has bacterial enteritis with one or more of the following causative pathogens either proven or presumed: c. difficile, salmonella, campylobacter, pathogenic e. coli, and other bacteria estimated to cause bacterial enteritis * the patient and his/her partner are willing to take contraceptive measures from initiation of investigational medicinal products (imps) to 4 weeks after administration of imps exclusion criteria: * the patient has severe or progressive underlying disease or complication, making it difficult to ensure safety in the study or proper efficacy assessment * the patient has a current diagnosis or history of convulsive disorders, such as convulsion and epilepsy * the patient has a severe hepatic dysfunction * the patient has a severe cardiac dysfunction * the patient has cardiac arrhythmia or congenital or sporadic long qtc syndrome. or the patient is treated with a drug reported to prolong qtc interval * the patient has a moderate or severe renal dysfunction * women with confirmed or suspected pregnancy or breast-feeding women * patients judged to be ineligible by the investigator for any other reasons
acute effects of whole body vibration in chronic stroke

Conditions: Stroke

Summary: whole body vibration has been found to be useful in promoting bone health, balance, and muscle performance in older adults. the overall aim of the proposed study is to determine whether whole body vibration (wbv) has immediate beneficial effect in neuromotor performance in patients with stroke. it is hypothesized that a single session of wbv will induce significant improvement in leg muscle strength in people with chronic stroke.


Eligibility criteria:
inclusion criteria: * a diagnosis of stroke * stroke onset \>6 months * \>18 years of age * \>able to walk for short distance independently with or without walking aid * able to understand simple verbal commands exclusion criteria: * other neurological conditions * peripheral vascular disease * vestibular disorders * significant musculoskeletal disorders (e.g. rheumatoid arthritis) * pregnancy

Keywords: vibration muscle cerebrovascular accident exercise rehabilitation