Kornimate/medical-research-clean huggingface dataset:
emanate: a study of setmelanotide in patients with specific gene variants in the mc4r pathway

Conditions: Obesity; Genetic Obesity

Summary: the protocol describes a randomized, double-blind, placebo-controlled trial with independent sub-studies of setmelanotide in patients with obesity and at least one of the specific gene variants in the melanocortin-4 receptor pathway: * pomc or pcsk1 (sub-study 035a) * lepr (sub-study 035b) * src1 (sub-study 035c) * sh2b1 (sub-study 035d) the objectives and endpoints are identical for these sub-studies.


Eligibility criteria:
inclusion criteria: * patients must have a pre-identified: * heterozygous genetic variant in the pomc gene or pcsk1 gene * heterozygous genetic variant in the lepr gene * homozygous, heterozygous, or compound heterozygous variant in the ncoa1 (src1) * homozygous, heterozygous, or compound heterozygous variant in sh2b1 gene, or chromosomal 16p11.2 deletion encompassing the sh2b1 gene * between 6 and 65 years of age at the time of provision of informed consent/assent * obesity, defined as bmi ≥30 kg/m2 for patients ≥18 years of age or bmi ≥95th percentile for age and gender for patients 6 up to 17 years of age * patient and/or parent or guardian is able to understand and comply with the requirements of the study and is able to understand and sign the written informed consent/assent * patient and/or parent or guardian reports that patient experienced childhood obesity, defined as the patient and/or parent or guardian reporting that the patient was significantly overweight during childhood * agree to use a highly effective form of contraception throughout the study and for 90 days following the study * reported history of lifestyle intervention of diet and exercise * reported history of hyperphagia key exclusion criteria: * weight loss of 2% or greater in the previous 3 months * recent history of bariatric surgery * significant psychiatric disorder(s) * suicidal ideation, attempt or behavior * clinically significant pulmonary, cardiac, endocrine/metabolic, hepatic or oncologic disease * glycated hemoglobin (hba1c) \>10% at screening * history of significant liver disease or severe kidney disease * history or close family history (parents or siblings) of melanoma, or patient history of oculocutaneous albinism * significant dermatologic findings relating to melanoma or pre-melanoma skin lesions (excluding non-invasive basal or squamous cell lesion) * participation in any clinical study with an investigational drug/device within 3 months prior to the first day of dosing * previously enrolled in a clinical study involving setmelanotide or any previous exposure to setmelanotide * significant hypersensitivity to any excipient in the study drug * if female, pregnant or breastfeeding

Keywords: melanocortin-4 receptor pathway genetic obesity hunger hyperphagia pomc pcsk1 lepr sh2b1 ncoa1 (src1)
infant colic treatment with probiotics

Conditions: Infant Colic

Summary: this study evaluates the efficacy of bifidobacterium breve cect7263 and the mixture b. breve cect7263/lactobacillus fermentum cect5716 in the treatment of infant colic. group 1 will receive b. breve cect7263 (2x10e8 cfu/day) one dose per day, group 2 will receive b. breve cect7263 (1x10e8 cfu/day) and l. fermentum cect5716 (1x10e8 cfu/day) in one dose per day, group 3 (control group) will receive simethicone 20 mg 4 times a day.

infant colic affects between 3-40% depending on the different criteria used for diagnosis. recent studies carried out in healthy infants have shown that the consumption of b. breve cect7263 and l. fermentum cect5716 during the first months of life are related to a lower risk to present episodes of crying characteristic of infantile colic. the objective of the present study is to compare the effect of b. brevis and b. brevis\\l mixture. fermentum with respect to simethicone. it is a multicenter, controlled, randomized, blind, parallel-group, 4-weeks nutritional intervention study which will be conducted in 18 public and private hospitals and health centers from spain.

Eligibility criteria:
inclusion criteria: * infants from 3 to 12 weeks of age * born at least at week 34 * birth weight equal to or greater than 2000 grams * fulfill the criteria of rome iii * informed consent signed by parents or guardians exclusion criteria: * failure to thrive * antibiotic treatment less than 2 weeks before the study or during the study * take probiotics as a treatment, different from the one that could contain the powdered infant formula * abandon breastfeeding and switch to infant formula * failure to comply with the study protocol

Keywords: infant colic bifidobacterium breve lactobacillus fermentum
a trial comparing shr-1139 injection with placebo in patients with moderate-to-severe plaque psoriasis

Conditions: Moderate to Severe Plaque Psoriasis

Summary: the objective of this study is to evaluate the efficacy, safety, pharmacokinetics (pk) and immunogenicity of shr-1139 injection in patients with moderate to severe plaque psoriasis.


Eligibility criteria:
inclusion criteria: 1. male or female, age ≥ 18 years old at the time of signing the informed consent form (icf). 2. subjects voluntarily sign informed consent form (icf) prior to the commencement of any procedures related to the study, are able to communicate smoothly with the investigator, understand and are willing to complete the study in strict compliance with the requirements of this clinical study protocol. 3. a fertile female subject or a male subject whose partner is a fertile woman who has not had a child, has a sperm/egg donation plan for 72 weeks from the date of signing the informed consent form to the last dose, and is voluntarily using highly effective contraception (including the partner). 4. female subjects must have negative pregnancy test results during the screening period and before randomized administration, and must be non-lactating. exclusion criteria: 1. there are other skin problems that researchers believe can interfere with the evaluation of psoriasis. 2. a history of moderate to severe congestive heart failure, cardiovascular and cerebrovascular events or severe bleeding events occurred in the 3 months before screening, and the investigator considered this subject to be unfit for clinical study. 3. had an opportunistic infection within 6 months prior to screening. 4. allergic to the ingredients or excipients of the study drug. 5. the investigator determined that there were conditions that affected the safety and efficacy evaluation of the study drug.
reversed tess shoulder artroplasty

Conditions: Humerus Fracture; Degenerative Shoulder Pain; Degenerative Supraspinatus Rupture

Summary: reverse total shoulder arthroplasty (rsa) is a accepted treatment for different shoulder diseases with improved functional outcome. this study has evaluated patients operated with reversed shoulder arthroplasty after 1,5-3 years postoperatively with patient reported outcome, clinical and radiological examination, complication and reoperations. the radiologic phenomenom and clinical impact of scapular notching (sn) and arm length difference has been evaluated.


Eligibility criteria:
inclusion criteria: * operated with a reversed tess total shoulder arthroplasty at sundsvall hospital. exclusion criteria: * do not give informed consent * do not attend follow-up

Keywords: reversed shoulder arthroplasty treatment tess
drainage versus sealant in double blinded monocentric open incisional hernia repair

Conditions: Incisional Hernia

Summary: mesh repair for open incisional hernia repair with fibrin sealant or with drainage


Eligibility criteria:
inclusion criteria: * all patients with a large incisional hernia \>5cm diameter that needs elective repair with mesh augmentation exclusion criteria: * no written informed consent * 'hostile' abdomen * emergency surgery (incarcerated hernia) * parastomal hernia * incisional hernia outside the midline * recurrent incisional hernia
immune response to hpv vaccine among hiv-1-infected subjects in brazil

Conditions: Infection

Summary: besides the specific response to vaccine antigens, the investigators will analyze the anti-hpv immune response in hiv-1-infected men in different strata of immune deficiency. the hypothesis will be tested by stratification by t cd4 + lymphocytes in an attempt to assess the range of the count with the highest possibility of vaccine response. thus, knowledge of vaccine response in hiv-infected patients, indicate which patients would have greater potential for vaccine response in vivo.

the study will be divided into three groups. patients with hiv-1 infection will be subdivided into groups according to t cd4 + lymphocytes at the time of vaccination: over 500 cd4 t cells count and bellow 500 cd4 t cells count. a healthy control group will be also studied.

Eligibility criteria:
inclusion criteria: hiv * men with age between 35 and 45 years of age. exclusion criteria: * current or previous infection with human papillomavirus (hpv)

Keywords: hiv hpv clinical trial outcome
feasibility of a web-based, peer-supported exercise program for patients with hip and/or knee osteoarthritis

Conditions: Osteoarthritis, Knee; Osteoarthritis, Hip

Summary: in this project, a web-based exercise program is developed in co-creation between specialized health care, the norwegian association for rheumatic diseases (nrf) and a group of experienced patient representatives. the project emerges from the evidence that exercise is recommended as first-line treatment for patients with chronic diseases like hip- and knee-osteoarthritis (oa). however, the number of patients in need of targeted exercise will increase considerably the next decades, and their treatment needs cannot be fully handled within the health care system. development of innovative and effective treatment trajectories and follow-up strategies is urgently required. peer-support is recognized as an effective way to increase patients' long-term adherence to exercise. thus, patient-organizations may be an unutilized resource in support and follow-up of patients who need long-term exercise as part of their treatment plan. after discharge from examination in hospital, patients with hip/knee oa will be recruited to follow-up in a novel web-based, peer-supported exercise program, and the feasibility of the intervention will be evaluated.

the study will be conducted as a pre-post single-arm feasibility study comprising 50 participants. the main objective of the study will be to evaluate the feasibility of the web-based, peer-supported exercise intervention in patients with hip and/or knee oa. specific research objectives are: * to assess feasibility of intervention delivery, data collection, eligibility and inclusion/exclusion criteria and intervention fidelity * to assess the responsiveness of relevant primary and secondary outcome measures in the feasibility study, all participants will be allocated to an intervention group, receiving a 12-week web-based, peer-supported aerobic exercise program including weekly motivational messages. patients between 40 and 80 years of age that are not candidates for surgery will be recruited from diakonhjemmet hospital, oslo, norway. to assess and evaluate feasibility, we will report on descriptive statistics. responsiveness will be assessed using receiver operating curve (roc) analyses.

Eligibility criteria:
inclusion criteria: • patients with hip and/or knee osteoarthritis being referred to diakonhjemmet hospital exclusion criteria: * candidate for surgery * unable to understand or write norwegian * unable to walk unaided and continuously for 15 minutes * absolute or relative contradictions to maximal exercise testing * have relatives with sudden death before 40 years of age * have first-degree relatives with hypertrophic cardiomyopathy

Keywords: exercise
jam3 as a prognostic biomarker in muscle-invasive urothelial carcinoma: correlation with therapeutic response, and survival outcomes

Conditions: Urothelial Carcinoma Bladder

Summary: bladder cancer(bc) is the 10th most common cancer globally, with a higher incidence in males than females, being the 6th most common cancer in men with high mortality, causing a societal burden worldwide. known risk factors include age, gender, cigarettes, genetic factors, and other environmental influences . bc can be classified into non-muscle-invasive bc (nmibc) and muscle-invasive bc (mibc) . mibc exhibits a more aggressive nature, correlates with a higher level of t-stage, and has more significant genetic heterogeneity . despite comprehensive treatment regimens comprising neoadjuvant chemotherapy, radical cystectomy (rc) and adjuvant immunotherapies, a significant proportion of mibc patients continue to progress to more advanced stages with limited clinical indicators. unfortunately, the mechanisms underlying bc initiation, proliferation, and progression remain largely unknown. the occurrence of genetic alterations is believed to be closely linked to bc tumorigenesis. therefore, investigating the genetic alterations might offer opportunities to further understand biological changes in bc . a key mechanism underlying tumor progression and metastasis is the epithelial-mesenchymal transition (emt), which is associated with increased invasiveness, chemoresistance, and immune evasion. emt is characterized by the downregulation of epithelial markers such as e-cadherin (cdh1) and the upregulation of mesenchymal markers like n-cadherin (cdh2), vimentin, snail, and zeb proteins . emerging evidence suggests that junctional adhesion molecule 3 (jam3) plays a role in emt and cancer progression, with documented involvement in gastric cancer. however, its significance in mibc remains poorly understood. investigating jam3 expression in mibc may provide novel prognostic insights and help refine patient stratification for nac and immunotherapy. aim: this study aims to analyze jam3 expression in transurethral biopsies from miuc patients and correlate it with: * tumor aggressiveness (grading, staging, and histological features). * response to neoadjuvant chemotherapy . * patient survival and disease progression. this study will provide a better understanding of jam3's role in emt and miuc progression, offering potential biomarker-driven insights for treatment stratification. if jam3 is validated as a prognostic factor, it could guide personalized therapeutic approaches and optimizing nac outcomes.


Eligibility criteria:
inclusion criteria 1. patients above 18 years 2. histopathological confirmed tcc 3. patients with mibc 4. patients eligible for neoadjuvant chemotherapy exclusion criteria 1. patients with metastatic disease 2. patients ineligible for systemic therapy
development of early detection signs for gastrointestinal cancer

Conditions: GI Cancer

Summary: therapies involving the immune system have already shown great promise in early clinical trials for the treatment of renal cell carcinoma and melanoma. one of the great challenges now facing this field is to extend these findings to other cancers. little is currently understood about the nature of the immune response to more common gastrointestinal cancers. the first goal of this proposal is to collect blood and tissue samples from patients with early or late stage gastrointestinal cancers. these samples will be evaluated to better understand the immune response to these two cancers. the second goal of this proposal is to evaluate the specimens of these patients for changes and genetic markers that correlate with the presence of cancer. the information gathered from these studies will directly enhance our ability to design, conduct and monitor novel immunotherapeutic protocols for the treatment of patients with gastrointestinal cancer.

the first goal of this proposal is to collect cells from the peripheral blood, tumor draining lymph nodes and tumor infiltrating lymphocytes in patients with early or late stage gastrointestinal cancers. these samples will be evaluated in a variety of immunological assays to better understand the immune response to these two cancers. the second goal of this proposal is to evaluate using novel proteomic, cellomic, and genomic techniques the serum and peripheral blood lymphocytes of these patients for protein, cellular changes and genetic markers that correlate with the presence of cancer. the information gathered from these studies will directly enhance our ability to design, conduct and monitor novel immunotherapeutic protocols for the treatment of patients with gastrointestinal cancer.

Eligibility criteria:
inclusion criteria: * histologically confirmed gi malignancy * suspected gi malignancy * high risk individual as assessed by their physician

Keywords: cancer gi tumor gastrointestinal high risk
the hybrid combination of ccta and spect and cag for evaluation prognosis of cad: an observational follow-up study

Conditions: Coronary Disease

Summary: a total of 550 patients with stable angina (40-70% stenosis) tested by coronary ct angiography (ccta) and single photon emission computed tomography (spect) and coronary angiography (cag) within 3 months were retrospectively recruited from 2005 to 2015 and follow up to 5 years. a new hybrid software was used to analysis the image data.


Eligibility criteria:
inclusion criteria: 1. age: 18-70 2. gender: all 3. coronary artery disease patients (cad) 4. underwent ccta, spect and coronary angiography (cag) together within 3 months 5. time: 2005-2015 exclusion criteria: 1. dilated cardiomyopathy (dcm), hypertrophic cardiomyopathy (hcm), congenital heart disease (chd), atrial fibrillation (af), ventricular tachycardia (vt) 2. prior coronary revascularization; 3. permanent pacemaker or internal defibrillator 4. prosthetic heart valve 5. coronary image lose 6. coronary artery severe calcification 7. motion artifacts and poor ccta image quality

Keywords: spect ccta cag hybrid
a sad/mad study of safety, tolerability and pharmacologic activity of bt200 in normal volunteers

Conditions: Cerebrovascular Stroke; Large-Artery Atherosclerosis (Embolus/Thrombosis); Intracranial Arteriosclerosis

Summary: study bt200-01 is a first in human (fih) study in male and female normal human volunteers (nhvs) that uses an integrated protocol design. this phase 1 study will comprise 4 sub-parts: part a, a single ascending dose (sad) study; part b, a multiple ascending dose (mad) study; part c, a desmopressin challenge study to explore (i) whether desmopressin could be used as an antidote, and/or (ii) whether desmopressin stimulated vonwillebrand factor (vwf) release is overcome with increasing bt200 doses; and part d, a relative bioavailability (ba) study. the primary objective of this study is to assess the safety and tolerability profile of bt200 in nhvs.


Eligibility criteria:
inclusion criteria: 1. healthy male or female volunteers, age ≥ 18 years old at screening 2. if female, must be post-menopausal or status post hysterectomy 3. able to comprehend and to give informed consent 4. able to cooperate with the investigator, to comply with the requirements of the study, and to complete the full sequence of protocol-related procedures exclusion criteria: 1. clinically significant medical history (including von willebrand disease, thrombocytopathy, or any type of bleeding diathesis) or ongoing chronic illness that would jeopardize the safety of the subject or compromise the quality of the data derived from his/her participation in this study 2. clinically relevant abnormal findings on physical examination or clinically relevant laboratory abnormalities 3. history of infusion hypersensitivity reactions, significant drug allergy, or anaphylactic reactions 4. substance abuse, mental illness, or any reason that makes it unlikely in the judgment of the investigator for the subject to be able to comply fully with study procedures 5. use of medication during 2 weeks before the start of the study, which in the judgment of the investigator may adversely affect the subject's welfare or the integrity of the study's results 6. concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days or 5 elimination half-lives (whichever is longer) prior to treatment start

Keywords: secondary stroke prevention
a study of ro4905417 in patients undergoing coronary artery bypass graft (cabg) surgery

Conditions: Coronary Heart Disease, Graft Occlusion, Vascular

Summary: this randomized double-blind, placebo-controlled study will evaluate the efficacy and safety of ro4905417 in the prevention of saphenous vein graft disease in patients undergoing elective or urgent coronary artery bypass (cabg) surgery. patients will be randomized to receive either ro4905417 20 mg/kg by intravenous infusion or placebo every 4 weeks for 32 weeks.


Eligibility criteria:
inclusion criteria: * adult patients, \> 18 and \> 85 years of age * patients undergoing primary multi-vessel cabg with at least one saphenous vein graft. with or without cardiopulmonary bypass * body mass index (bmi) \</= 35 kg/m2 exclusion criteria: * participation in previous studies evaluating ro4905417 * positive for hiv, receiving antiretroviral drugs, or immuno-suppressed * acute infection at screening or active chronic infection within 3 months prior to cabg surgery * patients undergoing emergency cardiac surgery for an immediately life-threatening condition * patients undergoing concomitant valve surgery * history of cabg (only patients without prior cabg surgery will be admitted to the study) * left ventricular ejection fraction \< 20% * history of transient ischemic attack or stroke within the 12 weeks prior to the cabg procedure * significant renal or liver impairment * malignancy diagnosed within the previous 5 years (except for successfully resected basal cell cancer)
clinical study on treatment of chronic persistent bronchial asthma

Conditions: Bronchial Asthma

Summary: investigators aimed to evaluate the clinical efficacy of integrated traditional chinese and western medicine in the treatment of asthma, and to further optimize the prescription of chinese medicine treatment.

the incidence of asthma in china is high and the rate of control is low. traditional chinese medicine has a long history of treating asthma, and has a good clinical curative effect.the purpose of this study is to evaluate the clinical efficacy of traditional chinese medicine in the treatment of asthma, and to further optimize the prescription of chinese medicine treatment. in this study, investigators recruited chronic persistent asthma participants, and gave the corresponding western medicine background treatment and traditional chinese medicine treatment program for 28 days.participants will undergo a physical examination, lung function, blood and sputum collection.

Eligibility criteria:
inclusion criteria: * patient diagnosed with chronic persistent asthma * patients had positive bronchodilator reversibility test or positive bronchial challenge test or more than 50 parts per billion of feno before * conform to the predetermined 2 tcm syndrome types * patients who have given written informed consent exclusion criteria: * smoking and continuous exposure to hazardous environment * with fever, or severity of intermittent state, high degree of sustained, or with respiratory failure, etc. * pulmonary emphysema, chronic obstructive pulmonary disease, pulmonary emphysema, pulmonary heart disease, pneumonia, lung cancer and other lung diseases * patients who are allergic to therapeutic medicine

Keywords: treatment； bronchial asthma