Kornimate/medical-research-clean huggingface dataset:
safety and efficacy study of intracranially implanted carmustine to treat recurrent malignant glioma

Conditions: Anaplastic Astrocytoma; Anaplastic Oligodendroglioma; Anaplastic Oligoastrocytoma; Glioblastoma

Summary: the purpose of the study is to determine the safety and efficacy of intracranially implanted carmustine in the treatment of patients with recurrent malignant glioma.

malignant gliomas recur mostly 2 cm within originated area. local therapies therefore become particular important. gliadel wafer developed in the states and marketed in the developed countries is an example of such treatments. the product in this study, carmustine sustained release implant (casant), is similar to that of gliadel wafer as for the api(active pharmaceutical ingredient), but different as for drug delivering system. as required, the preliminary clinical studies were conducted in china. based on the results of phase i/ii , 8-10 wafers containing given dose of bcnu will be administered intracranially in this phase iii to the tumor resected cavity to investigate the safety and efficacy in the treatment of recurrent malignant glioma in 212 patients.

Eligibility criteria:
inclusion criteria: * patients must be 18 to 70 years old, signed icf; * at least 4 weeks after previous chemotherapy (6 weeks since nitrosoureas); * kps ≥ 60; * unilateral, supratentorial, solitary lesion and not crossing the midline(exclude patients with little tumors near the resectable tumor even if investigators think they are single lesions) * no obvious important organ dysfunction: blood routine: white blood cell (wbc) ≥ 4.0×109/l, absolute neutrophil count (anc)≥ 1.5×109/l, platelets≥ 100×109/l, hemoglobin≥ 90 g/l; hepatic function:serum total bilirubin ≤1.5 times upper limit of laboratory normal; aspartate aminotransferase (ast) and/or alanine aminotransferase (alt)\<2.5 times upper limit of laboratory normal; renal function:serum creatinine ≤1.5 times upper limit of laboratory normal; * not pregnant or lactating for women of childbearing potential. exclusion criteria: * tumor located at ventricular system, open ventricle tumor cavity postoperatively; * concomitant with other life-threatening diseases and with life expectancy \<3 months; * allergic to nitrosourea drugs; * with history of intracranial radiotherapy or implant chemotherapy; * with serious cardiac, pulmonary, hepatic and renal dysfunction, poor glycemic control; * investigators thought unsuitable for enrollment.
study to assess the efficacy and safety of different doses of bim 23a760 in patients with carcinoid syndrome

Conditions: Carcinoid Syndrome

Summary: the purpose of the protocol is to assess the efficacy and safety of bim 23a760 on patient's overall satisfaction in terms of symptom relief (diarrhoea and/or flushes) in patients with carcinoid syndrome after 24 weeks of treatment.


Eligibility criteria:
inclusion criteria: * the patient has a carcinoid syndrome defined as ≥3 stools/day and/or ≥3 flushes/week. * the patient has elevated 5-hydroxyindoleacetic acid (above upper limit normal). * the patient has a well-differentiated mid-gut carcinoid tumour or serotonin secreting tumour of unknown localisation with hepatic metastasis. exclusion criteria: * the patient has undergone surgery related to a neuroendocrine tumour (net) within 4 weeks prior to study entry or has surgery planned during the study. * the patient has received short acting somatostatin analogues (ssas) within 2 weeks before study entry or has received short acting ssas for more than 3 months. * the patient has received a radiolabelled ssa at any time before study entry. * the patient has received long acting ssas under certain circumstances. * the patient has previously received any specific anti tumour treatment such as chemotherapy, (chemo)embolisation, radiotherapy or interferon in the last 6 months. * the patient has signs or symptoms of cardiac insufficiency. * the patient has an ejection fraction \<40% and/or clinically severe cardiac valvular regurgitation.
folic acid for vascular outcome reduction in transplantation (favorit)

Conditions: Chronic Kidney Disease; Cardiovascular Disease; Death

Summary: the purpose of this randomized clinical trial is to determine if lowering homocysteine levels in renal transplant recipients with a multivitamin will reduce the occurrence of cardiovascular disease outcomes.

the hypothesis of the trial is as follows: treatment with a high dose combination of folic acid, vitamin b6, and vitamin b12 will reduce the rate of pooled arteriosclerotic cardiovascular disease outcomes (i.e., pooled occurrence of non-fatal and fatal arteriosclerotic outcomes, including coronary heart, cerebrovascular, and peripheral vascular disease events) relative to treatment with an identical multivitamin containing no folic acid, and estimated average requirement amounts of vitamin b6, vitamin b12, among chronic, stable renal transplant recipients

Eligibility criteria:
inclusion criteria: * 35 - 75 years old * had kidney transplant at least 6 months * calculated creatinine clearance must be 25 ml/min or greater * must be willing to stop supplements (b6, b12, folic acid) for 4-6 weeks prior to visit exclusion criteria: * if pregnant or lactating * if of child bearing potential and not on birth control * if any of the following will limit life expectancy to less than 2 yrs: * cancer * congestive heart failure (chf) (end stage) * liver disease (end stage) * severe pulmonary disease * progressive hiv * any other chronic wasting illness * if patient had myocardial infarction (mi), stroke, lower extremity amputation above ankle or percutaneous revascularization procedure (coronary, cerebrovascular, lower extremity) in past 2months * if patient had coronary artery bypass graft (cabg) or abdominal aortic aneurysm (aaa) in past 5 months * if patient has conditions that prevent reliable study participation e.g., depression, alcohol or drug abuse, other cardiovascular disease (cvd) studies * if patient has had multi-organ transplant, except kidney/pancreas

Keywords: homocysteine multi-vitamin cardiovascular disease renal transplant recipients
a study of an investigational medication for the treatment of secondary hyperparathyroidism in patients on dialysis

Conditions: Secondary Hyperparathyroidism; End Stage Renal Disease

Summary: this 6 month study will assess an investigational medication for patients on dialysis with secondary hyperparathyroidism. the study will look at the effects on parathyroid hormone, calcium and phosphorus levels.


Eligibility criteria:
patients must be receiving hemodialysis; have elevated parathyroid hormone levels; not be pregnant or nursing; and not have had a heart attack in the last 3 months.
a study to evaluate the safety, tolerability, and efficacy of long-term gantenerumab administration in participants with alzheimer's disease (ad)

Conditions: Alzheimer Disease

Summary: this is an open-label, multicenter, rollover study to evaluate the safety, tolerability, and efficacy of long-term administration of open-label gantenerumab in participants with ad who completed study wn29922 or wn39658, either the double-blind or open-label extension (ole) part.

participants who were in the active arm in the double blind part and those who have completed ole part in the parent study, will continue receive open-label gantenerumab 510 mg sub-cutaneously (sc) every 2 weeks (q2w). participants who are naive to gantenerumab treatment will be required to undergo the 3 step uptitration scheme as in the parent study before receiving target dose of open label gantenerumab.

Eligibility criteria:
inclusion criteria: * completed study wn29922 or wn39658, either its double-blind part or ole part, and did not discontinue study drug early * the participant should be capable of completing assessments either alone or with the help of the caregiver * availability of a person (referred to as the "caregiver") * for women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception methods with a failure rate of \<1% per year (bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices) during the treatment period and for at least 16 weeks after the final dose of gantenerumab * agreement not to donate blood or blood products for transfusion for the duration of the study and for 1 year after final dose of study drug exclusion criteria: * pregnant or breastfeeding, or intending to become pregnant during the study or within at least 16 weeks after the final dose of study drug * prematurely discontinued from study wn29922 or wn39658 * any medical condition that may jeopardize the participant's safety if he or she continues to receive study treatment * received any investigational treatment other than gantenerumab during or since completion of study wn29922 or wn39658, either its double-blind or ole part * evidence of disseminated leptomeningeal hemosiderosis * evidence of intracerebral macrohemorrhage * use of prohibited medication * evidence of aria-e on the last mri scan report in study wn29922 or wn39658, either its double-blind or ole part
modeling tic change during behavior therapy for tics

Conditions: Chronic Tic Disorder

Summary: chronic tics are a disabling neuropsychiatric symptom associated with multiple child-onset mental disorders. chronic tics affect 1-3% of youth and can be associated with impaired functioning, emotional and behavioral problems, physical pain, diminished quality of life, and peer victimization. chronic tics are the primary symptom of tourette syndrome (ts) and persistent motor/vocal tic disorders. cbit is a manualized treatment focused on increasing tic controllability. its core procedure is competing response training (crt), in which patients learn to inhibit tics by learning and applying a competing motor action to one tic at a time. cbit is recommended as a first-line treatment relative to medications and other therapies. however, only 52% of children and 38% of adults show clinically meaningful tic improvement. large randomized trials have demonstrated the superiority of cbit over supportive therapy in child and adult patients, and meta-analysis shows comparable effect sizes for cbit and medication. although increasing tic controllability is the primary goal of cbit, tic controllability nor its correlates have been examined longitudinally during the intervention. the overall objective of this study is to use fine-grained data collection strategies to identify patterns in tic controllability and other relevant related variables that are associated with treatment response to cbit. participants with chronic tics will complete a manualized course of 8-session cbit. behavioral, psychosocial, and global functioning will be assessed longitudinally to examine predictors and correlates of response. cbit sessions will be video recorded.


Eligibility criteria:
inclusion criteria: * age 12-21 years at time of enrollment. * current chronic motor and/or vocal tics, defined as tics for at least 1 year without a tic-free period of more than 3 consecutive months. tics must not be due to a medical condition or the direct physiological effects of a substance. * at least moderate tic severity, defined as a yale global tic severity scale total score ≥14 (≥9 for those with motor or vocal tics only). * full scale iq greater than 70 * english fluency to ensure comprehension of study measures and instructions. exclusion criteria: * active suicidality. * previous diagnosis of psychosis or cognitive disability. * substance abuse or dependence within the past year. * concurrent psychotherapy focused on tics. * neuroleptic/antipsychotic medications. * taking a medication that has not reached stability criterion (same medication and dose for 6 weeks with no planned changes over the intervention period)
impact of virtual reality in cardiac electrophysiology

Conditions: Pain, Acute

Summary: pain during pacemaker or defibrillator implantation can increase patient discomfort, anxiety, and the need for deeper sedation. using virtual reality (vr) as a non-pharmacological distraction tool may help reduce perceived pain, stabilize vital signs, and improve the overall patient experience. this prospective, single-center study evaluates whether adding vr to standard sedation lowers pain levels compared to sedation alone. patients undergoing device implantation will be randomized to either group, with pain and vital signs monitored throughout the procedure. the study also explores patient satisfaction, adverse effects, and the potential of vr to support same-day discharge after minimally invasive procedures.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * patients who are candidates for pacemaker (pm) or implantable cardioverter-defibrillator (icd) implantation, including new devices such as leadless pm and subcutaneous icd (s-icd). * ability to provide written informed consent. * ability to understand the use of the vr headset and express a pain score using the nrs scale. exclusion criteria: * severe cognitive, psychiatric or neurological disorders that impair understanding or collaboration in the study. * visual and/or auditory and inner ear disorders or severe vertigo that could be aggravated by vr. * allergies or known adverse reactions to standard sedative therapies provided for in the protocol (e.g. midazolam) if essential for the procedure. * inability to correctly position the vr headset (e.g. severe facial deformities, recent trauma to the craniofacial area).
safety, tolerability, pharmacokinetic and pharmacodynamic study of abt-652 in subjects with excessive daytime sleepiness

Conditions: Sleep Disorder

Summary: the main purpose of this study is to evaluate the safety and tolerability of the drug abt-652 given once daily to people with excessive daytime sleepiness. subjects will be randomized to either abt-652 or placebo in three sequential dosing groups for a 1-week treatment period.


Eligibility criteria:
inclusion criteria * has current diagnosis of an excessive daytime sleepiness disorder, including narcolepsy, idiopathic hypersomnia, and obstructive sleep apnea * age 18 to 60 years exclusion criteria * has significant suicidal ideation * has a history of substance abuse * has a history of a certain significant medical conditions, including uncontrolled psychiatric diseases or disorders * use of certain medications

Keywords: sleep disorder
vitamin k antagonist, factor xa inhibitor or no anticoagulation in atrial fibrillation and dialytic end-stage renal disease (visionaire)

Conditions: Atrium; Fibrillation; Chronic Kidney Diseases

Summary: visionaire (vitamin k antagonist, factor xa inhibitor or nothing in atrial fibrillation and dialytic end-stage renal disease) trial will be a prospective randomized open-label with blinded endpoint adjudication trial including 1500 patients with atrial fibrillation or atrial flutter and advanced chronic kidney disease


Eligibility criteria:
inclusion criteria: * patients with clinical atrial fibrillation or flutter (persistent, paroxysmal or permanent); * cha2ds2-vasc ≥ 2 points (≥ 3 if female); * chronic kidney disease with estimated glomerular filtration rate (egfr) ≤ 15 ml/min/1.73 m2 by the ckd-epi equation (confirmed by two lab results at least 3 months apart) or on chronic renal replacement therapy (of note: number of patients included in no renal replacement therapy stratum will be capped at around 30% from the total study population). exclusion criteria: * active bleeding or severe bleeding \< 1 month; * prior kidney transplantation; * refusal de provide consent * severe chronic liver disease (child c); * other indication of oral anticoagulation (e.g.,: venous thromboembolism or pulmonary embolism); * prior intracranial hemorrhage; * bleeding disorder (other than uremia); * platelet count \< 50,000 / mm3 ; * pregnancy or breastfeeding; * mechanical valvar prosthesis; * moderate to severe mitral stenosis; * need for antithrombotic drugs other than single antiplatelet agents, or need for dual antiplatelet therapy with aspirin plus an adp receptor blocker; * any comorbidity beyond ckd and cv disease (e.g., metastatic cancer) which, in the investigator´s opinion, may impact survival in 12 months.

Keywords: atrial fibrillation atrial flutter oral anticoagulation dialysis
effectiveness of osteopathic manipulative treatment (omt) and vestibular rehabilitation therapy (vrt) in individuals with vertigo

Conditions: Vertigo; Dizziness; Benign Paroxysmal Positional Vertigo; Labyrinthitis

Summary: western university of health sciences is seeking men and women to participate in a study on the effectiveness of osteopathic manipulative treatment (omt) and vestibular rehabilitation therapy (vrt) in patients with vertigo. the purpose of this study is to examine the efficacy of omt in the treatment of individuals with vertigo, alone and in combination with vestibular rehabilitation therapy (vrt). because of the health care costs associated with vertigo, the cost effectiveness of omt and vrt will also be examined.


Eligibility criteria:
inclusion criteria: * symptoms of dizziness or a diagnosis of vertigo for longer than 3 months duration * able to tolerate 30 minutes of sitting and standing * able to transfer from sitting to standing and move independently * able tolerate manual therapy and exercise exclusion criteria: * severe traumatic injury * bleeding disorders and anticoagulation (coumadin) therapy * currently receiving vrt, vision therapy, or manual medicine (omt, chiropractic, etc.) or received manual medicine within the past three months * down syndrome * ehlers-danlos syndrome * endolymphatic hydrops * legal blindness in one or both eyes * menieres disease * neurological conditions (including peripheral neuropathy, stroke, traumatic brain injury, cerebral aneurysm, and multiple sclerosis) * rheumatoid arthritis * spinal trauma or history of cervical spine surgery

Keywords: dizziness vertigo benign paroxysmal positional vertigo labyrinthitis osteopathic manipulative treatment vestibular rehabilitation therapy
men engagement in women empowerment for improving maternal mental health through cash transfer and life skills building

Conditions: Empowerment; Domestic Violence; Depression; Self Efficacy

Summary: this project aims to offer life skills building (lsb) intervention to benazir income support program (bisp) cash transfer (ct) beneficiaries in couples in order to reduce domestic violence and depression and improve women empowerment in married women of reproductive age. the intervention will be carried out in the rural settlements of district thatta, sindh pakistan.

the study will assess the impact of life skill building (lsb) to benazir income support program (bisp) cash transfer (ct) beneficiaries and their husbands in improving maternal mental and child health and its combined effect in empowering women and couples. the formative phase of the project was dedicated for the development and modification of national level lsb curriculum for men and women. the formative phase was carried out in thatta (sindh), rahimyar khan (punjab), lasbela (baluchistan) and peshawar (kpk). the intervention phase will be conducted in district thatta, where bisp beneficiaries along with their spouses will be offered a lsb training. this intervention will be offered by community teachers to ensure sustainability and community trust. the participants will be recruited for baseline assessment followed by a comprehensive lsb intervention.the end-line follow up assessments (five months of intervention) will be done after the deliver of intervention. a qualitative summative inquiry will be done at the completion of the project to explore the overall impact of the lsb intervention. since the project is being implemented with the bisp, the cost of intervention can be estimated for the scalability and sustainability.

Eligibility criteria:
inclusion criteria: * adult married couples living together: where women receive benazir income support program (bisp) cash transfer (ct), have one child of at least 18 months and have no family migration plan for next 2 years exclusion criteria: * gross mental impairment in either of the partners * either of the partner is physically challenged or bedridden

Keywords: maternal depression women empowerment life skills building
narrative medicine for improving well-being in patients with gastrointestinal cancers

Conditions: Malignant Digestive System Neoplasm

Summary: this clinical trial assesses whether narrative medicine methods may improve the sense of well-being among gastrointestinal (gi) (digestive system) cancer patients. narrative medicine is a clinical approach where providers can use a patient's own narrative (perspective) of their illness to promote healing and resilience. by applying narrative medicine's main tool, close reading, to clinical practice, clinicians learn to listen and attend to patients more deeply. this allows for freer communication and the creation of a healthcare encounter that centers on the psychological and emotional well being of the patient in addition to their medical conditions. narrative medicine can include close reading, creative or reflective writing, and discussion. these methods may help patients with gi cancer to reflect on their life stories, both inside and outside of their illness experience, and help them gather skills to optimize their well-being.

primary objectives: i. to assess the feasibility of implementing narrative medicine tools in serial workshops with patients with malignancy. ii. to determine if narrative medicine interventions improve markers and expressions of well-being. descriptive objectives: i. to estimate changes in markers and expressions of well-being after 3 sessions of narrative medicine intervention. ii. to determine, through qualitative methods, if patients find benefit from the intervention regarding their well-being. iii. to decide whether to expand these kinds of interventions to a larger study with control group. outline: patients participate in narrative medicine sessions over 60 minutes once every 2 weeks (q2w) for 3 sessions. after completion of study intervention, patients are followed up at 1 and 3 months.

Eligibility criteria:
inclusion criteria: * patients with diagnosis of gastrointestinal malignancy actively receiving infusional therapy for cancer. * age \>= 18 years. * english speaking with ability to participate in reading and writing questionnaires and implementation tools. * performance status =\< eastern cooperative oncology group (ecog) 3. exclusion criteria: * altered mental status or other cognitive impairment, organic or drug induced that would limit ability to participate in the evaluation.