Kornimate/medical-research-clean huggingface dataset:
safety and efficacy study of amg 073 in hemodialysis subjects

Conditions: Hyperparathyroidism

Summary: subjects on hemodialysis will be randomized to amg 073 or placebo. the screening period is a maximum of 30 days followed by a 26-week treatment period. lab assessments will be completed throughout the study along with pro assessments.


Eligibility criteria:
inclusion criteria: * men and women greater than or equal to 18 years of age * using effective contraceptive measures * mean ipth during screening of greater than or equal to 300 pg/ml * mean calcium during screening of greater than or equal to 8.4 mg/dl * stable on hemodialysis exclusion criteria: * unstable medical conditions * parathyroidectomy within 3 months * change in vitamin d therapy * receiving antidepressants * experienced an mi within 3 months * inability to swallow tablets * previously received amg 073
recall by genotype: neuropeptide stimulation

Conditions: Reproductive Disorder

Summary: the objective of this protocol is to assess response to kisspeptin and gonadotropin-releasing hormone (gnrh) stimulation testing as well as the baseline patterns of luteinizing hormone (lh) secretion in individuals who carry variants in genes related to infertility.

assignment: all study subjects will undergo the same interventions. individuals at high risk for infertility (i.e., carry variants in genes related to infertility) will be compared to controls (i.e., those who do not carry variants in genes related to infertility). delivery of interventions: * prior to the inpatient study visit, the subjects will undergo a review of their medical history, physical exam, and screening laboratories. * on the day of the study, the subjects will have an intravenous (iv) line placed and * undergo up to q10 min blood sampling x 12 hours * receive a single kisspeptin iv bolus at hour 8 * receive a single gnrh iv bolus at hour 11

Eligibility criteria:
inclusion criteria: * no prescription medications that could interfere with hypothalamic reproductive function * no illicit drug use * no excessive alcohol consumption (more than 10 drinks/week) * no history of an allergic medication reaction requiring emergency medical care * normal blood pressure reading (systolic blood pressure \< 140 mm hg, diastolic \< 90 mm hg) * white blood cell, platelet counts, prolactin, and thyroid-stimulating hormone (tsh) between 90% of the lower limit and 110% of the upper limit of the reference range * normal hemoglobin * blood urea nitrogen (bun), creatinine not elevated * aspartate aminotransferase (ast), alanine aminotransferase (alt) within 3 times upper limit of normal * enrolled in the partners healthcare biobank and genotypically characterized * for women * no oral contraceptives for at least 1 month * no contraceptive implants for at least 3 months * not breastfeeding and not pregnant * negative serum human chorionic gonadotropin (hcg) pregnancy test at the time of screening (additional urine pregnancy test will be conducted prior to drug administration)

Keywords: reproductive disorders kisspeptin infertility gnrh
isatuximab in combination with cemiplimab in relapsed/refractory multiple myeloma (rrmm) patients

Conditions: Plasma Cell Myeloma

Summary: primary objectives: * to evaluate the safety and tolerability of the combination of isatuximab (also known as sar650984) and cemiplimab (also known as regn2810) in patients with relapse/refractory multiple myeloma. * to compare the overall response of the combination of isatuximab and cemiplimab versus isatuximab alone in patients with rrmm based on international myeloma working group (imwg) criteria. secondary objectives: * to evaluate the efficacy as assessed by clinical benefit rate (cbr), duration of response (dor), time to response (ttr), progression free survival (pfs), and overall survival (os). * to assess the pharmacokinetics (pk) of isatuximab and cemiplimab when given in combination. * to assess the immunogenicity of isatuximab and cemiplimab when given in combination.

the duration of the study for a patient will include a period for screening of up to 21 days and 3-month post treatment follow up. the cycle duration is 28 days. patients will continue treatment until disease progression, unacceptable adverse events, consent withdrawal, or any other reason.

Eligibility criteria:
inclusion criteria: * patients must have a known diagnosis of multiple myeloma with evidence of measurable disease, as defined below: * serum m-protein ≥1 g/dl (≥0.5 g/dl in case of immunoglobulin a \[iga\] disease), and/or * urine m-protein ≥200 mg/24 hours, or * in the absence of measurable m-protein, serum immunoglobulin free light chain ≥10 mg/dl, and abnormal serum immunoglobulin kappa lambda free light chain ratio (\ 1.65). * patients must have received prior treatment with an immunomodulatory drug (imid) (for ≥2 cycles or ≥2 months of treatment) and a proteasome inhibitor (pi) (for ≥2 cycles or ≥2 months of treatment). * patients must have received at least 3 prior lines of therapy (note: induction therapy and stem cell transplant ± maintenance will be considered as one line). * patient must have achieved mr or better with any anti-myeloma therapy (ie, primary refractory disease is not eligible). exclusion criteria: * prior exposure to isatuximab or participated clinical studies with isatuximab. * prior exposure to any agent (approved or investigational) that blocks the programmed cell death-1 (pd-1)/pd-l1 pathway. * evidence of other immune related disease/conditions. * history of non-infectious pneumonitis requiring steroids or current pneumonitis; history of the thoracic radiation. * has received a live-virus vaccination within 30 days of planned treatment start. seasonal flu vaccines that do not contain live virus are permitted. * has allogenic haemopoietic stem cell (hsc) transplant. * prior treatment with idelalisib (a pi3k inhibitor). * eastern cooperative oncology group (ecog) performance status (ps) \>2. * poor bone marrow reserve. * poor organ function. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: anti-cd38 monoclonal antibody
salvage of infected cardiovascular implantable electronic devices (cied) by localized high-dose antibiotics

Conditions: Infection

Summary: following previous positive experience with regulated cita-rnpt of infected cieds, we suggest increasing the number of recruited patients and that cita-rnpt can be administered prophylactically to patients prior to replacement of previously treated cieds, immuno-compromised patients, and others.


Eligibility criteria:
inclusion criteria: * high-risk patients for cied infections * cied infections exclusion criteria: * systematic infection

Keywords: cardiac resynchronization therapy devices
effect of topical bromelain versus topical corticosteroids in the management of oral lichen planus

Conditions: Oral Lichen Planus

Summary: bromelain, an enzyme extract derived from pineapples, has shown promise due to its anti-inflammatory and wound-healing properties. however, its efficacy in treating oral mucosal ulcers remains unexplored. this study aims to provide clinical evidence on the efficacy of bromelain for managing olp, potentially offering a safer and more effective treatment option.


Eligibility criteria:
inclusion criteria: * patients suffering from symptomatic olp * patients free from any visible oral lesions other than olp. * patients who agreed to take the supplied interventions. * patient who will agree to participate in the study. * patients who will accept to sign the informed consent. exclusion criteria: * patients suffering from any systemic disease. * treatment with any systemic treatment such as systemic steroids, other immunosuppressive drugs or non-steroidal anti-inflammatory drugs at least eight weeks. * treatment with any oral topical medications for at least four weeks prior to the study. * pregnant and lactating mothers.
laryngeal mask airway (lma) protector for minimally invasive thyroidectomy

Conditions: Sore Throat; Dysphagia; Postoperative Pain

Summary: the patients will be allocated to 2 groups: the lma group and the endotracheal tube (et) group. airway management will be done with the lma protector for the patients of the lma group and with the classic endotracheal tube for the patients of the et group. the main purpose of the study is to determine if the application of the lma protector causes less laryngopharyngeal symptoms than the endotracheal tube after minimally invasive thyroidectomy. the secondary purpose is to confirm that the lma protector is a safe alternative airway management device for minimally invasive thyroidectomy.


Eligibility criteria:
inclusion criteria: * total thyroidectomy with the minimally invasive method. * american society of anesthesiologists (asa) classification 1-3 exclusion criteria: * clinical conditions which cause any kind of airway obstruction or compromise. * tracheal displacement greater than 2cm from midline. * history of gastroesophageal reflux disease. * expected difficult airway. * history of impossible intubation. * bmi\>35 * reoperation within 24hours.
corneal changes after retinal surgery

Conditions: Rhegmatogenous Retinal Detachment

Summary: the purpose of this study is to evaluate the corneal changes after performing 20 gauge vitrectomy associated with scleral buckling for the treatment of rhegmatogenous retinal detachment.

patients submitted to 20-gauge vitrectomy associated with scleral buckling were evaluated with corneal topography before surgery and in the 7,30 and 90 days after surgery to asses corneal curvature changes.

Eligibility criteria:
inclusion criteria: * patients with rhegmatogenous retinal detachments exclusion criteria: * previous eye surgery
dietary modification in inflammatory bowel disease patients

Conditions: Crohn Disease

Summary: this research project aimed to develop a culturally appropriate asian inflammatory bowel disease diet for the malaysian population, based on the crohn's disease exclusion diet (cded). the study will be conducted in inflammatory bowel disease patients in university malaya medical centre, which are ulcerative colitis and crohn's disease patients. the objectives of this study are to assess the impact of diet in clinical outcome and gut microbiota changes in patients with inflammatory bowel disease (ibd). the study duration spans 24 weeks, during which comprehensive follow-ups will be conducted at 0, 6, 12, and 24 weeks, respectively. at each follow-up session, participants will be requested to provide stool and blood samples for meticulous assessment of clinical and biochemical responses.

inflammatory bowel disease is a chronic gut inflammation due to immune system dysregulation. although the exact causes remain unknown, patients' dietary habits were shown to affect the disease activity depending on the food exposure, either proinflammatory or anti-inflammatory food. this randomized-controlled trial (rct) study aims to improve the modified cded diet that is acceptable for the malaysian population at universiti malaya medical centre. this study comprised of three parts: (part 1: in-depth interview to measure the acceptance of the diet, part 2: implementation of the cded diet, part 3: identification of change in gut microbiome post dietary intervention). the duration of the study is two years.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of crohn's disease according to established clinical, endoscopic, and histological criteria. * mild to moderate diseases (150 to 220 points). * written informed consent obtained. exclusion criteria: * presence of stoma. * surgery within 6 months prior to randomization. * patient on exclusive enteral nutrition (een).
research of zoledronic acid and aromatase inhibitors as adjuvant therapy to breast cancer

Conditions: Breast Cancer

Summary: select patients of primary breast cancer whose hormone receptor is positive and accepted postoperative adjuvant aromatase inhibitors for endocrine treatment.treat them with zoledronic acid 4mg intravenous infusion every six months until the end of the aromatase treatment. assess the disease-free survival; overall survival; combination of security, as well as the situation of bone loss.

the investigators select patients of primary breast cancer whose hormone receptor is positive and accepted postoperative adjuvant aromatase inhibitors for endocrine treatment.treat them with zoledronic acid 4mg intravenous infusion every six months until the end of the aromatase treatment. assess the disease-free survival; overall survival; combination of security, as well as the situation of bone loss.

Eligibility criteria:
inclusion criteria: 1. karnofsky≥70 2. provision of informed consent 3. pathological confirmation of breast cancer 4. hormone receptor-positive and accept aromatase inhibitors for adjuvant endocrine therapy 5. not previously received treatment with bisphosphonate 6. laboratory criteria: plt≥100\*109/l wbc≥4000/mm3 hgb≥10g/dl got,gpt,alp≤2\*uln tbil,dbil,ccr≤1.5\*uln 7. surgery , radiotherapy and chemotherapy has finished exclusion criteria: 1. pregnant of lactation woman 2. history of organ transplantation 3. with mental disease 4. with severe infection or active gastrointestinal ulcers 5. with severe liver disease (such as cirrhosis), kidney disease, respiratory disease or diabetes 6. disease-free period of other malignant tumor is less than 5 years(except cured basal cell skin cancer and cervical carcinoma in situ) 7. with heart disease 8. experimental drug allergy
getting to zero among black msm in the american south

Conditions: HIV Infections

Summary: hptn 096 is a community-randomized, controlled, hybrid-type iii implementation effectiveness study. it is designed to evaluate an integrated strategy approach to increase the uptake and use of pre-exposure prophylaxis (prep) and viral suppression rates among black msm in the southern united states. a status-neutral approach will be taken such that black msm, regardless of hiv status (both those living with and without hiv), will be included in the study.


Eligibility criteria:
the baseline and post-implementation assessment participants will be persons who: * self-identify as black man (inclusive of cisgender and transgender men) * self-report a lifetime history of sex with other men * are at least 15 years of age * self-report current residence in the community of interest * are willing and able to provide informed consent * agree to complete a short questionnaire * agree to provide two blood samples (one by fingerstick and another by venipuncture). hiv status will not be ascertained prior to participation in these assessments and eligible black msm may participate regardless of hiv status.

Keywords: pre-exposure prophylaxis (prep) men who have sex with men (msm) black men who have sex with men (black msm) hiv incidence viral suppression status-neutral approach southern united states health equity social media influencers (smi) intersectional stigma reduction peer support black treatment advocates networks (btan) ending the hiv epidemic (ehe) black aids institute (bai) culturally responsive intersectional stigma prevention (crisp) integrated strategy community-randomized social determinants of health community mobilization community-based participatory research
study to establish image interpretation criteria for 18f fluciclovine pet in detecting recurrent brain metastases (pursue)

Conditions: Brain Metastases

Summary: an open-label, single-arm, single-dose, prospective, multicenter phase 2b study to establish image interpretation criteria for 18f-fluciclovine positron emission tomography (pet) in detecting recurrent brain metastases after radiation therapy


Eligibility criteria:
inclusion criteria: 1. eastern cooperative oncology group (ecog) performance status of 0-2 2. previous history of solid tumor brain metastasis of any origin 3. histopathological confirmation of the primary solid tumor or a metastatic site 4. previous radiation therapy of brain metastatic lesion(s) 5. a reference lesion considered by the site investigator to be equivocal for recurrent brain metastasis 6. patient requires further confirmatory diagnostic procedures to confirm brain mri findings and is planned for craniotomy exclusion criteria: 1. patients with a history of active hematological malignancy

Keywords: recurrent brain metastases diagnostic positron emission tomography (pet) scan
out of hospital cardiac arrest: trial assessing the survival impact of phone advice

Conditions: Out of Hospital Cardiac Arrest

Summary: medical call center have no phone advice protocol within out of hospital cardiac arrest in france. the purpose of the present study is to compare a group of patients with protocol phone advice delivered by the dispatchers ("contarm" group) versus usual phone advice ( "conthab" group). comparison will be performed on survival to seven days. the hypothesis is that contarm group has an higher survival at seven days. a second goal is to measure the survival to 15 and 30 days. the trial is randomized, controlled and will include 2600 patients. the patients will be enrolled in 19 hospitals in france.


Eligibility criteria:
inclusion criteria: * \> 18 years old * initial call to 15 * out of hospital cardiac arrest * patient proximity to witness exclusion criteria: * first aid professionals on site * rigor mortis * location not allowing resuscitation * inability to realize actions or misunderstanding * no flow \> 5 minutes
intensive treatment for chronic pain and posttraumatic stress disorder (ptsd)

Conditions: Stress Disorders, Post-Traumatic

Summary: this study is investigating the efficacy of an intensive (3 week) integrated treatment for veterans with both pain and ptsd.

objectives: the primary objective of this study is to evaluate the efficacy of an intensive integrated treatment for veterans with comorbid chronic pain and posttraumatic stress disorder (ptsd). a secondary objective is to examine potential mechanisms of action that might account for improvements in pain or ptsd. third, exploratory analyses will be conducted to assess the relationship between participation in treatment and cognitive functioning. it is hypothesized that 1) participants receiving the intensive treatment (pt) will report significantly greater decreases in symptoms of pain and ptsd from pre-treatment to post-treatment when compared to participants randomized to a standard care (sc) condition, and 2) participants receiving pt will show greater maintenance of change on measures of pain and ptsd at 3 months following the completion of treatment when compared to participants randomized to the sc condition.

Eligibility criteria:
inclusion criteria: * patients will be eligible to participate if they have constant pain of at least three months duration with a neurologic or musculoskeletal etiology. * patients must also meet diagnostic criteria for ptsd. exclusion criteria: * patients with life threatening or acute physical illness, current alcohol or substance abuse, current psychosis or suicidal ideation, and individuals seeking pain treatment such as surgical interventions will be excluded.

Keywords: psychology pain veterans stress disorders, post-traumatic
vasculogenic mimicry in urothelial carcinoma

Conditions: Urothelial Carcinoma

Summary: in this study, the investigators aim at: 1. evaluate the presence of vasculogenic mimicry in urothelial carcinomas by cd31-pas double staining. 2. correlate the presence of vasculogenic mimicry with the clinicopathologic features as age, sex, tnm stage, pathological grade, recurrence, carcinoma in situ, lymphovascular emboli, lymph node metastasis, necrosis, surgical margin, multifocality and tumor size in urothelial carcinoma.

bladder cancer is the ninth most common cancer worldwide which seriously affects human health. in egypt, it is the third common malignant tumor. urothelial carcinoma (uc) is considered the most common histologic type of bladder cancer. it is well recognized that the biological behavior of several cancers is closely related to their blood supply. tumor progression and metastasis have been long associated with tumor angiogenesis. however, several studies demonstrated that vascular targeting drugs which induce endothelial cell apoptosis have a little effect. so, it has been suggested that novel tumor microcirculation patterns may exist in these neoplasms. vasculogenic mimicry (vm), is a novel tumor microcirculation system. maniotis et al initially discovered vm in melanoma and defined these channels to be composed of tumor basement membrane lined externally by tumor cells, lacking blood vessel endothelium and containing plasma and red blood cells. so vm can be distinguished using immunohistochemical (ihc) staining and histochemical double staining. vm is cd31- or cd34-negative (endothelial markers) and periodic acid-schiff (pas) positive. vasculogenic mimicry was detected in several malignant tumors. several studies reported that vm can promote tumor progression and metastasis and it is positively associated with pathological grade, stage, recurrence and drug resistance. previous studies which evaluate, the role of vm in urothelial carcinoma yield controversial results. so, the value of vm in urothelial carcinomas and its relation to the clinicopathologic parameters remains to be elucidated.

Eligibility criteria:
inclusion criteria: * - specimens of urothelial carcinoma. exclusion criteria: * - any criteria that not fulfill the inclusion criteria such as resected urinary bladder tumors other than urothelial carcinoma.
pulmonary function test, bronchial hyperresponsiveness and quality of life in patients with vocal cord dysfunction (vcd)

Conditions: Dyspnea

Summary: vocal cord dysfunction is a rare clinical picture. it is labeled as a sudden and threatening dyspnea. patients with vcd may also present cough, hoarseness, wheezing, and chest tightness, but an inspiratory stridor is the most common symptom. for this reason, such patients are often misdiagnosed with refractory asthma, because of poor response to steroids and bronchodilators. diagnosis is suspected on clinical grounds and is confirmed with laryngoscopy. the therapy consists of education, speech therapy and if necessary psychotherapy. the purpose of the investigators' study is to characterize children, adolescents, and young adults with vcd, and the evaluation of predictors as atopy, bronchial hyperresponsiveness, and psychiatric features.

vcd appears to be significantly more common among females. the episode of dyspnea underlies the paradoxical, intermittent adduction of the vocal cords during inspiration. methacholine challenge testing combined with laryngoscopy is useful in differentiating vocal cord dysfunction from asthma during the asymptomatic period. in one visit patients will be characterized with a questionnaire based on the isaac questionnaire. furthermore, feno, eco, skin prick testing and total serum ige will be examined. the psychiatric condition of patients will be determined by cbcl/6-18 and ysr/11-18 behavior questionnaires. after initial fiberoptic laryngoscopy and pulmonary function testing, bronchoprovocation is performed using nebulized methacholine at increasing doses, until a 20% decline in the forced expiratory volume in 1 second is achieved (pd20fev1). each methacholine testing will be followed by a second laryngoscopy and pulmonary function testing. the visualization of paradoxical vocal cord motion during inspiration will be recorded.

Eligibility criteria:
inclusion criteria: * informed consent * age 7 to 30 years * documented vcd or strong suspicion of vcd * pulmonary function test: fev1 (% pred.) ≥ 70% exclusion criteria: * age \ 30 years * pulmonary function test: fev1 (% pred.) \< 70% * others chronic diseases or infections (e.g., hiv, tuberculosis, malignancy) * pregnancy * documented alcohol, substance, and/or drug abuse * incapability to perform all study procedure * current participation in another clinical trial

Keywords: vocal cord dysfunction laryngoscopy methacholine challenge pulmonary function testing