Kornimate/medical-research-clean huggingface dataset:
a first-in-human research study on how nnc0662-0419 works in people living with overweight or obesity

Conditions: Overweight; Obesity

Summary: this study is testing a new study medicine which may be used to treat people living with overweight or obesity. the purpose of the study is to see if the new study medicine is safe, how it works in human body and what human body does to the study medicine. participants will either get the study medicine nnc0662-0419 or placebo (a "dummy" medicine without any active ingredients) given by study staff as an injection under participants skin. which treatment participants will get is decided by chance. nnc0662-0419 is a new medicine, which cannot be prescribed by doctors. this is the first time the medicine is being given to humans. the study will last for about 9 months.


Eligibility criteria:
inclusion criteria: * male or female (sex at birth) * aged 19-55 years (both inclusive) at the time of signing the informed consent. * body mass index (bmi) between 27.0 and 39.9 kilogram per square meter (kg/m\^2) (both inclusive) at screening. overweight should be due to excess adipose tissue, as judged by the investigator. * considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. exclusion criteria: * known or suspected hypersensitivity to study intervention(s) or related products. * any disorder, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. * 2nd or 3rd degree atrioventricular-block, prolongation of the qrs complex over 120 milliseconds (ms), or of the corrected qt interval by fridericia (qtcf) calculation over 450 ms (females) or 430 ms (males), or any other clinically significant abnormal ecg results as judged by the investigator, at screening. * glycated haemoglobin (hba1c) greater than or equal to (\>=) 6.5 percent (%) (48 millimoles per mole \[mmol/mol\]) at screening. * calcitonin \>= 50 nanogram per liter (ng/l) at screening
the effect of implanon on menstrual patterns

Conditions: Menstrual Irregularities

Summary: this study aims to evaluate whether the timing of postpartum implanon insertion (immediately postpartum, early postpartum, or late postpartum) affects menstrual patterns

* etonogestrel implants (implanon) are widely used for postpartum contraception. however, the timing of insertion may influence menstrual patterns, including irregular bleeding, amenorrhea, and prolonged bleeding episodes. despite the increasing use of immediate postpartum contraception, there is limited research on how the timing of implanon insertion affects menstrual cycle regulation. * furthermore, lactation and hormonal changes postpartum may modify the bleeding patterns in women using implanon, with breastfeeding women experiencing a higher likelihood of amenorrhea due to prolactin-induced suppression of ovulation. * this study aims to fill these gaps by systematically comparing menstrual outcomes based on timing of implanon insertion postpartum

Eligibility criteria:
inclusion criteria: * postpartum women opting for implanon as contraception. * no contraindications to hormonal contraception. exclusion criteria: * . women with known bleeding disorders. * use of other hormonal contraceptives during the study period. * postpartum complications such as severe infections or retained products of conception
the effect of a-prf+ versus open flap debridement in the treatment of patients with stage iii periodontitis

Conditions: Intrabony Periodontal Defect

Summary: to assess the effectiveness of advanced prf+ as compared to open flap debridement in treatment of periodontal intraosseous defects in stage iii periodontitis patients.

the application of platelet concentrates characterized by high concentrations of platelets and growth factors have been applied and investigated as possible periodontal regenerative therapy. the application of platelet rich fibrin in management of intraosseous and furcation defects produce more favorable outcome compared to open flap debridement. a-prf+ represents the latest generation of platelet concentrates that could provide sustained and increased release of growth factors and could serve as an autologous cost-effective membrane in periodontal tissue regeneration procedures

Eligibility criteria:
inclusion criteria: * stage iii periodontitis patient having at least one tooth with 2-wall, 3-wall, or combined 2- to 3-wall intraosseous defect ≥ 3 mm in depth (assessed by bone sounding, radiographic examination) with clinical attachment level (cal) ≥ 5mm and pocket depth (pd) ≥ 6 mm. * defect not extending to a root furcation area * non-smokers. * no history of intake of medications affecting the periodontium in the previous 6 months. * able to sign an informed consent form. * patients age between 18 and 60 years old. * patients who are cooperative, motivated, and hygiene conscious. * systemically free according to cornell medical index (broadbent, 1951). exclusion criteria: * pregnancy or breast feeding * the presence of an orthodontic appliance * teeth mobility greater than grade i

Keywords: stage 3 periodontitis a-prf advanced platelet rich fibrin open flap debridement ofd 2-wall intraosseous defect 3-wall intraosseous defect
combination of lateral foot orthoses and knee brace for treatment of the knee osteoarthritis

Conditions: Osteoarthritis, Knee

Summary: the purpose of this study is to evaluate the immediate and short-term effects of the combination of lateral customized foot orthoses on the pain and medial knee loading during gait among medial knee osteoarthritis patients. the effects of the combination is compared to the single use of these devices. the investigators recruited 22 knee osteoarthritis. they have to wear each of treatments (foot orthoses, knee brace and combination) during three months. a fifteen days wash-out period is given after each three months. biomechanical evaluation is carried out before and after each three months. this evaluation consisted of three questionnaires (knee osteoarthritis outcome score (koos), western ontario and mcmaster universities osteoarthritis index ( womac) and medical outcome study short form-36( mos-sf36)), a motion analysis with an optoelectronic system, then a 6-min walk test. during motion analysis, ten gait trials are executed without treatment and ten with the treatment.


Eligibility criteria:
inclusion criteria: * symptomatic medial knee oa (kellgren-lawrence grade i, ii or iii) according to clinical and radiological criteria of the american college of rheumatology * knee pain \> 31/100 (western ontario and mcmaster universities arthritis index - womac) * moderately active * varus knee alignment equal or superior to 2° exclusion criteria: * severe knee oa (k-l grade iv) * rheumatoid arthritis or other inflammatory arthritis * avascular necrosis * history of periarticular fracture or septic arthritis * bone metabolic disease * pigmented villonodular synovitis * cartilaginous disease * neuropathic arthropathy * synovial osteochondromatosis * total or partial knee arthroplasty * flexion contracture of ipsi- or contra-lateral knee greater than 15° * hip or ankle joint damage with mobility limitation * obesity (bmi ≥ 40) * intra-articular corticosteroids injection in the affected knee during the two previous months * reduced mobility (charnley class c)
re-optimization based online adaptive radiotherapy of anal cancer

Conditions: Anal Cancer; Anal Carcinoma; Anal Squamous Cell Carcinoma

Summary: a single-arm, prospective, phase ii, single-center clinical trial that will investigate if daily online adaptive radiotherapy for anal cancer will significantly reduce early treatment-related gi toxicity compared with the historically reported rate for non-adaptive intensity modulated radiation therapy (imrt).


Eligibility criteria:
inclusion criteria: * biopsy-verified anal cancer * eligible for curative intended radiotherapy * written and oral consent exclusion criteria: * other malignant disease within the past 5 years (excluding basal cell carcinoma)

Keywords: adaptive radiotherapy anal cancer online adaptive radiotherapy (oart)
effect of different form of upper limb muscles training on dyspnea in copd

Conditions: COPD

Summary: evaluate the effect of upper limbs strength training versus the effect of upper limbs endurance training, on dyspnea, in patients with copd during a pulmonary rehabilitation program.


Eligibility criteria:
inclusion criteria: * patient with stage 2 to 4 (a to d) copd admitted to a pulmonary rehabilitation program (4 weeks) * patient aged 18 or over * patient able to consent and having signed a consent form exclusion criteria: * patient with pain, osteoarthritis or shoulder surgery * patient with a history of pneumonectomy, lobectomy less than 6 months old * refusal of participation * patient with an inability to complete a pulmonary rehabilitation program in totality * pregnant or breast-feeding women * patient under tutorship or curatorship
a study of arry-334543 and capecitabine in patients with advanced cancer

Conditions: Advanced Cancer

Summary: this is a phase 1 study during which patients with advanced/metastatic solid tumors will receive investigational study drug arry-334543 and capecitabine. patients will receive increasing doses of study drug in combination with capecitabine in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. patients will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. approximately 30 patients from the us and canada will be enrolled in this study.


Eligibility criteria:
key inclusion criteria: * histologically or cytologically confirmed diagnosis of any advanced/metastatic cancer suitable for treatment with capecitabine. pancreatic cancer is not allowed and patients with gastric or gastroesophageal junction (gej) cancer are only eligible if prior treatment did not include a total gastrectomy. * target lesions may be in a previously irradiated field only if progression of the lesion has been clearly documented. * eastern cooperative oncology group (ecog) performance status (ps) of 0, 1 or 2. * must be able to take and retain oral medications. * additional criteria exist. key exclusion criteria: * active concomitant malignancies. * uncontrolled or symptomatic brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must be stable for at least 30 days). * known dihydropyrimidine dehydrogenase (dpd) deficiency. * requiring intravenous (iv) alimentation. * known positive serology for the human immunodeficiency virus (hiv), hepatitis b and/or hepatitis c. * pregnancy or lactation. * chemotherapy, anticancer immunotherapy, monoclonal antibodies or biologics within 21 days prior to first dose of study drug. * anti-egfr and/or erbb2 small molecule targeted therapy or hormonal anticancer therapy within 14 days prior to first dose of study drug. * history of any hypersensitivity to or intolerance of capecitabine or any of its components, or to fluorouracil or any fluoropyrimidine therapy. * additional criteria exist.
pain control after minimally invasive coronary artery bypass grafting

Conditions: Postoperative Pain; Medication Side Effects; Narcotic Requirement

Summary: the purpose of this study is to compare postoperative pain control after minimally invasive coronary artery bypass grafting for patients who receive an intercostal block (an anesthetic medicine injected in an area under the ribs) in the operating room and iv acetaminophen (tylenol) to those who receive an intercostal block and on-q pain pump catheter (a balloon pump attached to 2 small tubes near your procedure site that automatically delivers pain medicine).


Eligibility criteria:
inclusion criteria: * 18 years of age or older * coronary artery disease requiring surgical intervention * no prior sternotomy * creatinine within normal limits (0.60 - 1.10 mg/dl) exclusion criteria: * less than 18 years of age * inability to provide consent or complete a written survey * previous history of sternotomy * contraindications to mics-cabg or to any of the components of the 2 analgesic regimens
phase 2b study of ngm282 extended treatment in patients with primary biliary cirrhosis

Conditions: Primary Biliary Cirrhosis

Summary: the purpose of this study is to determine the safety, tolerability, and activity of extended treatment with ngm282 in patients with primary biliary cirrhosis.


Eligibility criteria:
inclusion criteria: * completion of ngm 13-0103 * males or females, between 18 and 75 years of age, inclusive * pbc diagnosis consistent with aasld and easl guidelines * stable dose of udca exclusion criteria: * chronic liver disease of a non-pbc etiology * evidence of clinically significant hepatic decompensation
study of the effect of fluticasone furoate nasal spray on spring allergy eye symptoms

Conditions: Allergic Conjunctivitis to Tree Pollen or Grass Pollen

Summary: rationale and objectives: fluticasone furoate nasal spray (veramyst) has been shown to improve ocular symptoms when used for the treatment of seasonal allergic rhinitis during the ragweed pollen season. although this is the only published report of an intranasal corticosteroid shown to effectively treat ocular symptoms, the mechanism has not been delineated. furthermore, the tears of patients with allergic conjunctivitis are known to have increased concentrations of cytokines and allergic mediators. the objective of this study is to determine if the positive effects of veramyst nasal spray on ocular symptoms is via the inhibition of allergic mediators in the eyes. the investigators will conduct a double blind placebo controlled trial to determine if veramyst nasal spray decreases the amount of allergic mediators in the tears of subjects randomized to veramyst nasal spray versus placebo. the investigators will also compare the subjects' symptoms to the amount of allergic mediators detected in their tears.


Eligibility criteria:
inclusion criteria: * a documented history of allergic rhinitis and conjunctivitis due to tree pollen and / or grass pollen for two allergy seasons * positive skin prick test to tree and / or grass exclusion criteria: * glaucoma * cataracts * acute or chronic sinusitis * asthma * chronic obstructive pulmonary disease * physical nasal obstruction * pregnant or breastfeeding * have had a viral or bacterial infections within 2 weeks of the study commencement * receiving allergen immunotherapy * have used inhaled corticosteroids within 14 days prior to the study * have used systemic corticosteroids within 30 days of the study * travel outside of the geographic area during the 2 week study period * use of contact lenses during the study period * use of artificial tears during the study period * use of eyewash irrigation during the study period * use of lubricants during the study period
individualized music playlist based on iso principle for de-escalation of agitation in dementia

Conditions: Dementia

Summary: the goal of this clinical trial is to evaluate the efficacy of an individualized music playlist (inmp) composed of preferred music genres sequenced according to the iso-principle, for the immediate de-escalation of agitation in dementia, compared with preferred music (pm) and treatment as usual (tau).

1. study design - randomized controlled trial 2. participants - eighty-one older adults living with dementia and demonstrate significant agitation 3. setting: - residential care home 4. intervention - individualized music listening intervention played with an ipad and a wireless neckband speaker for 30 minutes when agitation begins in addition to usual care. 5. comparison conditions * preferred music listening group: preferred music listening played with an ipad and a wireless neckband speaker for 30 minutes when agitation begins in addition to usual care. * usual care group: usual care 6. outcomes * level of agitation measured with the pittsburgh agitation scale * intensity of agitation measured with the positive and negative syndrome scale - excited component * agitation occurrence frequency measured with cohen-mansfield agitation inventory * distress of formal caregivers related to agitation measured with neuropsychiatric inventory 7. focus group interviews with the care staff will be conducted as a process evaluation for identifying the potential facilitators and barriers related to implementation.

Eligibility criteria:
inclusion criteria: * residents in long-term care facilities * diagnosed with any type of dementia * presented with significant agitation exclusion criteria: * had been admitted to the facility for less than three months * are participating in other studies or experimental therapies * have a comorbid psychiatric illness * have physical illness that prevents them from listening to music

Keywords: dementia agitation music
disconnection technique with a bronchial blocker for improving lung deflation

Conditions: Pneumothorax

Summary: one lung ventilation (olv) is accomplished with a double lumen tube (dlt) or a bronchial blocker (bb). in this study, the investigators compared the effectiveness of lung collapse using dlt, bb with spontaneous collapse, and bb with disconnection technique.

in selecting this maneuver of olv, lung collapse is a major concern because it permits adequate surgical exposure. although once lung deflation was achieved, the overall clinical performance appears to be similar, bb takes longer to deflate the operative lung and there is some conflict reports as to bb provides a similar degree of lung deflation compared to that of dlt. the aim of this study was to compare the efficacy of bb and dlt for achieving lung collapse, and to evaluate the efficacy of disconnection technique with monitoring the carbon dioxide trace on a capnograph in bb. the investigators further evaluated the disconnection time, which is the time to loss of carbon dioxide trace on the capnograph, needed to facilitate lung collapse.

Eligibility criteria:
inclusion criteria: * patients undergoing thoracic surgery for which olv is required exclusion criteria: * patients with an anticipated difficult intubation with infectious or bleeding lung lesions are excluded.

Keywords: one lung ventilation efficacy bronchial blocker
biodentine vital pulpotomy in immature molars

Conditions: Pulp Exposure, Dental

Summary: this study aimed to evaluate the clinical and radiographic success of pulpotomy in cariously exposed vital immature first permanent molars using calcium hydroxide and calcium silicate-based material (biodentine ™). after a 12 months postoperative period, biodentine ™ proved very useful as a successful pulpotomy agent in young permanent teeth.

objective: this study aimed to evaluate the clinical and radiographic success of pulpotomy in cariously exposed vital immature first permanent molars using calcium hydroxide and calcium silicate-based material (biodentine ™). participants and methods: this study was carried out on patients attending an outpatient clinic in pediatric dentistry and dental public health department - faculty of dentistry - cairo university - egypt. a total of thirty-five patients had thirty-eight vital immature first permanent molar with deep caries, who satisfied the eligibility criteria and completed the follow-up period. their age ranged between six years to nine years old with a mean age of 7.5+/-1 years. all teeth were mandibular. in this study, pulpotomy was performed to preserve the vitality and function of the remaining radicular pulp tissue, followed by applying one of the investigated pulp capping materials.

Eligibility criteria:
inclusion criteria: * medical history: healthy children with no physical or mental disorders assured through medical history questioning. * mandibular vital immature first permanent molar with deep caries. restorable. no clinical evidence of extensive pulp degeneration or periapical pathology.no radiographic evidence of periapical pathosis or interradicular bone loss, internal/external resorption and pulp calcification. exclusion criteria: * 1. patients refuse to cooperate. 2. spontaneous pain or severe pain which doesn't stop with analgesics. 3. hemorrhage control wasn't achievable at the operative procedures
evaluation of sedation in covid-19 ards

Conditions: Prone Position; Severe Acute Respiratory Syndrome Coronavirus 2; Hypnotics and Sedatives; Pulmonary Ventilation

Summary: this study focuses on the evaluation of various factors repeatedly discussed in relation to the impaired sedation of intubated ventilated covid-19 patients. the sedation response of \>100 moderately to severely affected covid-19 ards was evaluated. the sedation level was measured at the bedside using the richmond agitation and sedation scale and ventilator synchrony. the evaluation was performed according to the static evaluation plan with respect to age, storage therapy and organ failure.


Eligibility criteria:
inclusion criteria: moderate to severe covid-19 ards exclusion criteria: none

Keywords: critical care acute respiratory distress syndrome
the momentum study (monitoring maternal emergency navigation and triage on mfangano

Conditions: Pregnancy; Neonatal Care; Emergency Care

Summary: this is an observational cohort study that will assess barriers influencing access to emergency pregnancy, obstetrical and neonatal care.

through a 12-month mixed methods, observational cohort study, investigators from maseno university, university of minnesota (umn) and ohr-ekc will assess barriers influencing access to emergency pregnancy, obstetrical and neonatal care among patients seeking care at 9 health centers on mfangano island, as well as the preliminary impact and feasibility/acceptability of the hn approach for improving access to mnh services and shortening delays in care.

Eligibility criteria:
overall inclusion criteria: * must be ≥18 years of age as of the date of study eligibility, or qualify as an emancipated minor (ie: person aged less than 18 years who was married, pregnant, or a parent, consistent with government of kenya guidelines and previous research such as kenya aids indicator survey-kais) * must be conversant with one of the commonly spoken languages within the study area (i.e. dholuo, swahili or english; prior experience indicates that this represents \>99% of the adult population) * must be willing to share confidential information about prenatal history, pregnancy course, obstetrical complications, clinical course, and experiences navigating health care system. * must have the ability to provide informed consent. emergency cohort-specific criteria: - participants will be either patients who have experienced a critical pregnancy-related, obstetric, or neonatal health emergency, or appropriate family member in the case that patient is not able to participate in interview due to death or illness or other circumstance. birth planning cohort-specific criteria: - all pregnant women who register a birth plan through the health navigation birth planning service will be eligible to enroll in the birth planning cohort focus group cohort-specific criteria: - all participants from the emergency cohort and the birth planning cohort will be eligible, as well as chw volunteers, and ohr-ekc and moh health facility staff exclusion criteria: * individuals under the age of 18 and who do not qualify as emancipated minors * individuals who do not speak either english, dholuo or swahili * individuals who are not comfortable sharing confidential information about prenatal history, pregnancy course, obstetrical complications, clinical course, and experiences navigating health care system.