Kornimate/medical-research-clean huggingface dataset:
study to evaluate the long-term safety, tolerability, and durability of treatment effect of alks 3831

Conditions: Schizophrenia; Schizophreniform Disorder; Bipolar I Disorder

Summary: this study will evaluate the long-term safety, tolerability, and durability of treatment effect of alks 3831 in subjects with schizophrenia, schizophreniform disorder, or bipolar i disorder


Eligibility criteria:
inclusion criteria: * willing and able to give informed consent/assent as per local requirements * agrees to use an acceptable method of contraception during the study, and for 30 days after any study drug administration, unless surgically sterile or post-menopausal * has the potential to benefit from the administration of alks 3831, in the opinion of the investigator * subject met the eligibility criteria of the antecedent study at the time of enrollment in the antecedent study and completed the treatment period in one of the following antecedent studies within 7 days: alk3831-a304, alk3831-a306, or alk3831-a307 * additional criteria may apply exclusion criteria: * has any finding that, in the view of the investigator or medical monitor, would compromise the safety of the subject or affect their ability to fulfill the protocol visit schedule or visit requirements * has a positive drug screen for drugs of abuse at study entry * currently pregnant or breastfeeding or is planning to become pregnant during the study or within 30 days of the last study drug administration * additional criteria may apply

Keywords: alkermes alks 3831 olanzapine samidorphan schizophrenia schizophreniform bipolar i
ultrasound guided percutaneous tracheostomy

Conditions: Tracheostomy Hemorrhage; Tracheostomy Complications; Other Tracheostomy Complications

Summary: the purpose of this study is to determine the feasibility and the safety of ultrasound guided percutaneous dilatational tracheostomy.

percutaneous tracheostomy is commonly performed in critical care units when ventilatory weaning fails or when prolonged mechanical ventilation is required. numerous complications have been described since the widespread use of percutaneous tracheostomy (pct). bronchoscopy-guided percutaneous tracheostomy was developed in this context. however, bronchoscopy cannot identify vascular structures and the thyroid gland in the neck, and therefore cannot prevent complications related to organ lesions in the neck. several studies have demonstrated the value of ultrasound guidance in the neck before performing pct. no studies have demonstrated the feasibility and the safety of ultrasound guidance for pct. ultrasound could improve the understanding of neck anatomy, prevents vascular puncture, and helps guide insertion of the tracheostomy tube.

Eligibility criteria:
inclusion criteria: * patients hospitalized in icu in whom percutaneous tracheostomy is indicated, * patients aged \> 18 years old, exclusion criteria: * age less than 18 years, * clotting disorder, * infection at the puncture site, * emergency tracheostomy

Keywords: percutaneous tracheostomy ultrasonography echography critical care
clinical performance of nanohybrid resin composite lined with prg barrier coat compared to resin modified glass ionomer in class v carious cavities over 18 months: randomized clinical trial

Conditions: Class V Dental Caries

Summary: class v carious lesions will be restored using two different restorative materials either resin modified glass ionomer or nanohybrid resin composite lined by prg barrier coat. each restoration will be evaluated for clinical parameters after finishing and polishing at baseline, at 6 months, 12 months and at 18 months. the restorations will be clinically examined according to modified usphs criteria in terms of retention, marginal adaptation, marginal discoloration, secondary caries and postoperative sensitivity.

class v carious lesions will be restored using two different restorative materials either resin modified glass ionomer or nanohybrid resin composite lined by prg barrier coat.each restoration will be evaluated for clinical parameters after finishing and polishing at baseline, at 3 months, 6 months, 12 months and at 18 months. the restorations will be clinically examined according to modified usphs criteria in terms of retention, marginal adaptation, marginal discoloration, secondary caries and postoperative sensitivity.

Eligibility criteria:
inclusion criteria: * 18-60 years males or females. patients with untreated cervical carious lesion that need restoration. participants available for recall patients with moderate to high caries risk teeth inclusion criteria no spontaneous pain absence of tooth mobility exclusion criteria: * patients with para-functional habits experience with allergic reactions against any component of used materials. teeth exclusion criteria non-vital teeth teeth with orthodontic appliance teeth with advanced periodontal diseases.

Keywords: prg barrier coat nanohybrid resin composite resin modified glass ionomer
a study on the effectiveness of ankle dorsiflexion range of motion training in patients with patellofemoral joint pain.

Conditions: Patellofemoral Pain, PFP

Summary: patellofemoral pain (pfp) is a common knee condition causing pain around the kneecap during activities like running or squatting. limited ankle flexibility ("dorsiflexion" - how far participants can lift their toes toward the shin) may worsen pfp by altering leg movements. this study investigates whether adding ankle flexibility exercises to standard knee-strengthening programs improves outcomes for young adults with pfp. active adults aged 18-30 with pfp and limited ankle flexibility (measured with a simple tool) are eligible, excluding those with prior knee/ankle surgeries, fractures, or conditions like arthritis. sixty-four participants will be randomly assigned to either an exercise + ankle training group (standard knee exercises plus targeted ankle training) or an exercise-only group for 8 weeks under physiotherapist guidance. outcomes include improvements in knee pain scores (kujala scale), ankle flexibility changes, and muscle coordination measured with non-invasive sensors. if effective, ankle flexibility training could provide a low-cost addition to current treatments, helping patients resume activities with less pain. the study follows international ethical guidelines and has received preliminary ethics approval (no. tjus-2025-054).


Eligibility criteria:
inclusion criteria: * aged 18-30 years * diagnosed with patellofemoral pain (pfp) per clinical guidelines (anterior knee pain aggravated by ≥2 activities: running, squatting, stair climbing) * ankle dorsiflexion range of motion (rom) \<10° (measured via goniometer in weight-bearing) * bmi 18.5-28 kg/m² * engage in regular physical activity (≥3 sessions/week) exclusion criteria: * ankle fractures * achilles tendon rupture * rheumatoid arthritis * gout, or systemic diseases * prior knee/ankle surgeries * concurrent lower limb injuries (e.g., ligament tears, meniscal pathology) * neurological disorders affecting mobility * participation in other lower limb rehabilitation programs within 3 months
infections associated with the use of alemtuzumab

Conditions: Patients Treated With Alemtuzumab

Summary: the aim of this study is to propose infection prophylaxis from asian multinational retrospective analysis of infectious complications in patients who were treated with alemtuzumab


Eligibility criteria:
inclusion criteria: * patients received alemtuzumab as a treatment for hematologic malignancy ex. non-hodgkin lymphoma acute myeloid leukemia aplastic anemia exclusion criteria: * patients did not receive alemtuzumab

Keywords: alemtuzumab, infection, prophylaxis, treatment
incidence of cancer in women at increased genetic risk of ovarian cancer

Conditions: Breast Carcinoma; Fallopian Tube Carcinoma; Ovarian Neoplasm; Primary Peritoneal Carcinoma

Summary: this clinical trial is studying the incidence of cancer in women at increased genetic risk of ovarian cancer. gathering information about genetic factors in women with an increased risk of ovarian cancer over time may help doctors learn more about the disease and find better methods of treatment and on-going care.

primary objectives: i. to determine the prospective incidence of ovarian cancer, fallopian tube cancer, breast cancer, primary peritoneal cancer, and all cancer among women at increased risk of ovarian cancer, with a special emphasis on women who are known breast cancer susceptibility gene (brca)1/2 mutation carriers. ii. to develop precise point estimates of these cancer rates among women who have undergone risk-reducing salpingo-oophorectomy and women who have elected screening. iii. to compare the cancer rates between these two groups of women. iv. to better characterize the similarities and differences in cancer risk between brca mutation-positive families and brca mutation-negative/family history-positive families. v. to develop preliminary estimates of overall and cancer-specific mortality, stratified by mutation status (brca1-positive, brca2-positive, brca1/2-negative). outline: this is a multicenter study. patients complete the health update questionnaire annually for up to 5 years. the questionnaire focuses specifically on cancer risk, incidence, and mortality. patients also receive ongoing communication (e.g., periodic newsletters, copies of study-related publications, etc.) to keep them informed regarding study-related research results, new research findings, new research opportunities for which patients may be eligible, and evolving clinical recommendations regarding hereditary breast/ovarian cancer.

Eligibility criteria:
inclusion criteria: * enrolled on gog-0199 * completed the original 5-year follow-up period or is off-study due to pregnancy or development of a new cancer * completed the off-study form (form q0-0199 submitted via sedes) * no patients who were off-study before the end of the initial 5-year follow-up period (found to be ineligible or consent withdrawal)
phase 1 study of hbn-1

Conditions: Cardiac Arrest

Summary: phase 1 first-in human randomized, open-label, active control standard of care study of the safety of hbn-1 administered as pharmacologically induced hypothermia as an adjunct to standard of care targeted temperature management in adult patients who have experienced out-of-hospital-cardiac arrest. hbn-1 will be administered iv as a loading dose infusion followed by a 12-hour maintenance infusion.

phase 1 first-in human randomized, open-label, active control standard of care study of the safety of hbn-1 administered as pharmacologically induced hypothermia as an adjunct to standard of care targeted temperature management in adult patients who have experienced out-of-hospital-cardiac arrest. hbn-1 will be administered as an iv solution according to a weight-based escalating loading dose infusion rate scheme involving three sequential cohorts with a loading dose of hbn 1 administered over 60 minutes (cohort a), 45 minutes (cohort b), or 30 minutes (cohort c). for all cohorts, the loading dose will be followed by a 12-hour maintenance infusion of hbn-1. dosing cohorts will include a minimum of 6 subjects randomized in a 2:1 ratio of hbn-1 plus standard of care versus standard of care alone. individual cohorts may be expanded to up to a maximum of 12 subjects . if the cohort is expanded, the additional subjects will receive hbn-1 + soc. during the loading dose and maintenance infusion, physical exam, temperature, assessment of shivering, ecg, vital signs, clinical laboratory, blood alcohol level, and neurologic status will be monitored.

Eligibility criteria:
inclusion criteria: 1. age 40 to 80 years, inclusive 2. documented diagnosis of ohca with ventricular tachycardia/fibrillation, asystole or pulseless electrical activity 3. return of spontaneous circulation within 50 minutes of the event 4. four motor score \<4 5. maximum estimated weight not to exceed 100 kg exclusion criteria: 1. return of spontaneous circulation \>8 hours 2. known history of prior cardiac arrest, alcohol, or substance abuse or dependence 3. presumed etiology of cardiac arrest is trauma, hemorrhage, or sepsis 4. comfort measures only or anticipated withdrawal of life-support within 24 hours 5. is within a protected population group (eg, pregnant or breastfeeding or incarcerated persons) 6. has history or evidence of significant hepatic dysfunction (sequential organ failure assessment hepatic score \>2) 7. any other condition, that in the opinion of the investigator, would preclude the subject from being a suitable candidate, e.g. end-stage chronic illness with no reasonable expectation of survival to hospital discharge 8. is able to obey to verbal commands 9. is receiving iv vasopressin or lidocaine hydrochloride

Keywords: therapeutic temperature management; therapeutic hypothermia
shortened course adjuvant radiotherapy following tors

Conditions: HPV-Associated Oropharyngeal Squamous Cell Carcinoma

Summary: this is a single-arm, phase ii study to establish the safety of reducing radiation dose in selected hpv-associated opscc patients receiving adjuvant radiation after tors and neck dissection. this protocol also allows for sparing of the primary resection bed, in appropriate patients, as previously published by our group and found to be safe and effective.

this is a single-arm phase ii non-inferiority study of adjuvant radiation for locally-advanced hpv-associated oropharyngeal squamous cell carcinoma. patients with pt0-t3, n0-n1, m0 disease (per ajcc 8th edition), detectable pre-operative and undetectable postoperative cthpvdna will be eligible. patients will have undergone tors primary site resection and neck dissection. patients will undergo adjuvant rt +/- guideline-indicated chemotherapy. the neck and the primary site will be considered separately. the primary objective of the study will be to determine the 2-year locoregional control (lrc) rate. secondary objectives include measures of toxicity (as measured by ctcae, version 5.0), patient-reported qol (as measured by the mdasi and mdadi questionnaire), progression-free survival, metastasis-free survival, and overall survival. differences between patients treated with imrt and proton therapy in terms of toxicity and qol will serve as another secondary objective.

Eligibility criteria:
inclusion criteria: * patients ≥ 18 years old * histologically confirmed diagnosis of squamous cell carcinoma of the oropharynx, p16-positive on immunohistochemistry or hpv-positive by in-situ hybridization * pathologic t0 (unknown primary), t1, t2, or t3 disease (per ajcc 8th ed) * pathologic n0-n1 disease (per ajcc 8th ed) * preoperative plasma cthpvdna of ≥ 50 copies/ml * undetectable postoperative plasma cthpvdna * ecog performance status 0-1 exclusion criteria: * prior external beam radiation therapy to the head and neck * presence of t4 disease * ≥ 5 positive lymph nodes (which is pathologic n2 disease, per ajcc 8th edition) * presence of distant metastatic disease * uncontrolled inter-current illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, connective tissue disease or psychiatric illness/social situations that would limit compliance with study requirements.
impact of purple wheat consumption on markers of inflammation and oxidative stress in adults.

Conditions: Healthy

Summary: the main purpose of this study is to determine the effect of consumption of purple wheat anthocyanin-rich products for eight weeks by human participants with an elevated level of chronic inflammation, on oxidative stress and inflammatory responses as measured by select plasma biomarkers.

this study will investigate the effect of daily consumption of purple wheat bran-enriched wholegrain convenience bars, for 8 weeks on inflammation and oxidative stress biomarkers and plasma antioxidant capacity. this study is a randomized, parallel arm study with 20 men and 20 women who will adhere to a low anthocyanin and low phenolic aid diet for the duration of the study. the participants will be randomly divided into two groups, using stratification for matching sex and screening hs-crp level to be equally distributed in each group, and assigned to either the treatment group or control group. both group will have a 10 day diet run-in period where consumption of foods rich in anthocyanins and phenolic acids will be limited. both groups will consume 4 servings of wheat products per day for 8 weeks and will replace 4 grain servings from their typical daily intake with the study treatment products. fasting blood samples will be collected during three study visits, including baseline, for the analysis of inflammatory and oxidative stress biomarkers and plasma antioxidant capacity. the plasma metabolites of anthocyanins and phenolic acids will also be determined.

Eligibility criteria:
inclusion criteria: * bmi ≥ 25 kg/m2 and/or waist circumference ≥102 cm (men) and ≥88 cm (women) * hs-crp: ≥ 1.0 mg/l at time of screening * stable (\>3 months) and consistent use of all prescribed medications and/or supplements * non- to moderate alcohol consumer (i.e. less than 5 drinks per sitting and no more than 14 per week) * not taking any antibiotics within the last 3 months, or planning to take antibiotics within the next 6 months exclusion criteria: * pregnant or breastfeeding females * lifetime history of any acute medical event, including but not limited to, heart attack or stroke * occasional or intermittent smoker (includes but not limited to tobacco and cannabis) * consistent smoker of \<1 year * recent diagnosis (within 6 months) of a serious medical condition, including but not limited to, cancer, diabetes, heart disease or hepatitis * recent history (within 6 months) of a clinically significant psychiatric disorder, other than mild depression * any disorder of the gastrointestinal system or food intolerances, including but not limited to, inflammatory bowel disease or celiac disease * any food allergies or any life-threatening allergies, food or otherwise * regular recreational drug use of more than once per week, including but not limited to cannabis, magic mushrooms, ecstasy etc * difficulty providing blood samples

Keywords: chronic inflammation adults overweight obese
platelet -rich plasma (prp) injection for the treatment of severe dry eye

Conditions: Dry Eye; Sjogren Syndrome

Summary: dry eye is a chronic condition that decreases function and affect visual function with severe discapacity until now treatments are based in artificial eye drops. platelet rich plasma has emerged as a strategy for cellular restoration, the purpose of this study is to evaluate their effects in lacrimal production and safety of this intervention in patients with severe dry eye.

dry eye is a chronic condition that decreases function and affect visual function with severe discapacity until now treatments are based in artificial eye drops. platelet rich plasma has emerged as a strategy for cellular restoration, the purpose of this study is to evaluate their effects in lacrimal production and safety of this intervention in patients with severe dry eye.

Eligibility criteria:
inclusion criteria: * • patients with symptomatic dry eye * shirmer ≤10 mm in 5 min * but ≤10 seconds * corneal staining ≥3 * age range: 18 years and older. * both genders and all ethnic groups comparable with the local community. * able to understand and willing to sign a written informed consent * able and willing to cooperate with the investigational plan. * able and willing to complete all mandatory follow-up visits. exclusion criteria: * • patients who are currently engaged in another clinical trial, unwilling or unable to give consent, to accept randomization, or to return for scheduled visits. * children under 18. * pregnant women or expecting to be pregnant during the study. * systemic immune deficient conditions such as aids or under systemic immunosuppressant. * concomitant use of systemic antibiotics or steroids. * contact lens wear * active ocular infection or allergy * unable to close eyes or uncontrolled blinking
68-ga-dotatate pet-ct scan for diagnosis of primary and metastatic somatostatin receptor-positive neuroendocrine tumors (nets)

Conditions: Neuroendocrine Carcinoma

Summary: to evaluate the concordance and discordance between results of 68ga-dotatate pet-ct scan and octreoscan ® which is considered standard of care diagnostic test for neuroendocrine cancers and other imaging modalities like ct scan/mri as gold standard.

the number of lesions that could be identified clearly as single foci will be determined for each patient. the same anatomic areas will be imaged with 68ga-dotatate pet and 111in-penteoctreotide scintigraphy to ensure relevant comparison of lesion detection. because of confluence and inability to clearly delineate single liver lesions in some cases, liver metastases will be classified as 1 organ metastasis, independent of the number of liver metastases present. lymph nodes smaller than 1 cm on ct or mri and showing marked avidity for 68ga- dotatate and 111in-penteoctreotide will be labeled as positive for disease. the presence of lesions will be confirmed by cross-sectional imaging of all patients with ct or mri.

Eligibility criteria:
inclusion criteria: * signed informed consent * subjects of either sex, aged ≥18 years * histologically and/or clinically confirmed and/or suspected net and/or a diagnostic imaging study including but not limited to ct or mri or fdg pet/ct, naf pet/ct, bone scan, ultrasound, etc. of the tumor region or suspected area within the 4 weeks of dosing day * recent blood test results (within 2-4 weeks predose) as wbc: ≥2 x 109/l, haemoglobin: ≥8.0 g/dl, platelets: ≥50 x 109/l, alt, ast, ap:≤ 5 times uln \[ uln for alt, ast and ap is 70, 20 and 20 units/i respectively\], bilirubin: ≤3 times uln \[uln for total bilirubin is 1.3mg/dl\] * serum creatinine: serum creatinine: \<170 μmol/l * egative pregnancy test in women capable of child-bearing exclusion criteria: * known hypersensitivity to dota, to 68gallium, to octreotate or to any of the excipients of 68ga-dotatate * therapeutic use of any somatostatin analogue, including sandostatin® lar (within 28 days) and sandostatin® (within 2 days) prior to study imaging. if a patient is on sandostatin® lar a wash-out phase of 28 days is required before the injection of the study drug * pregnant or breast-feeding women * current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study
effects of antihypertensive treatment in hiv infected patients: candesartan versus lercanidipine

Conditions: HIV Infections; Hypertension

Summary: human immunodeficiency virus infection and highly active antiretroviral therapy (haart) are associated with an increased risk of cardiovascular disease: a wide range of alterations in lipid and glucose metabolism has been increasingly recognized in hiv patients treated with haart. few data are available on the effects of antihypertensive treatment on cardiac morpho-functional characteristics and metabolic parameters in hiv patients. aim of the study is to assess the effects of chronic therapy with angiotensin receptor blocker(candesartan)or calcium channel blocker (lercanidipine)on metabolic profile and cardiac remodelling in hiv hypertensive patients.


Eligibility criteria:
inclusion criteria: * hiv infection * office blood pressure \> 140/90 mmhg * no antihypertensive treatment * good quality echocardiogram exclusion criteria: * cardiovascular diseases * hypothyroidism * diabetes * secondary hypertension * hepatic and renal failure

Keywords: hiv blood pressure left ventricle metabolic profile treatment experienced