Kornimate/medical-research-clean huggingface dataset:
vaccine therapy in treating patients with ovarian, fallopian tube, or peritoneal cancer

Conditions: Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

Summary: rationale: vaccines made from a person's cancer cells may make the body build an immune response to kill the tumor cells. purpose: phase i trial to study the effectiveness of vaccine therapy in treating patients who have ovarian, fallopian tube, or peritoneal cancer.

objectives: i. determine the safety of immunization with glycosylated muc-1-klh vaccine plus adjuvant qs21 in patients with ovarian, fallopian tube, or peritoneal epithelial cancer. ii. determine the dose of this treatment regimen for optimal antibody response in these patients. iii. determine the effect of immunization with this treatment regimen on the t-cell response in these patients. outline: this is a dose escalation study of glycosylated muc-1-klh vaccine. patients receive glycosylated muc-1-klh vaccine and qs21 subcutaneously once a week on weeks 1-3, 7, and 19. cohorts of 6 patients receive escalating doses of glycosylated muc-1-klh until the dose for optimal antibody response without unacceptable toxicity is determined. patients are followed at 2 and 12 weeks, and then every 3 months thereafter as long as detectable immunity against muc-1 persists. projected accrual: a total of 18-24 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically confirmed ovarian, fallopian tube, or peritoneal epithelial cancer (any stage at diagnosis) prior cytoreductive surgery required refractory or recurrent after at least one prior regimen of platinum based chemotherapy no evidence of disease following salvage chemotherapy, defined as: ca125 less than 35 units negative physical examination no evidence of disease on ct scan of abdomen and pelvis patient characteristics: age: 18 and over performance status: karnofsky 70-100% life expectancy: not specified hematopoietic: wbc at least 3,000/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin, sgot, and alkaline phosphatase less than 2 times normal renal: creatinine less than 1.6 mg/dl creatinine clearance at least 50 ml/min other: no other concurrent active invasive malignancy no seafood allergy no positive stool guaiac (excluding hemorrhoids) prior concurrent therapy: biologic therapy: not specified chemotherapy: see disease characteristics endocrine therapy: not specified radiotherapy: not specified surgery: not specified

Keywords: recurrent ovarian epithelial cancer fallopian tube cancer primary peritoneal cavity cancer
multiple ascending dose trial of byk324677 in healthy volunteers

Conditions: Type 2 Diabetes Mellitus

Summary: this monocenter trial is conducted to obtain first data on safety, tolerability, pharmacokinetics (pk) and pharmacodynamics (pd) after multiple ascending doses of byk324677 in humans. in addition, the trial should provide preliminary information on a possible influence of sex, food intake, and posology (once or twice daily administration of byk324677) to support the further planning of the drug development programme.


Eligibility criteria:
inclusion criteria: * given written informed consent * healthy male and female subjects. assessed as healthy based on a screening examination including medical history, physical examination, blood pressure (systolic ≤140 mmhg, diastolic ≤90 mmhg), pulse rate (within 45-95 bpm), ecg assessment, and clinical laboratory results * body mass index (bmi) between ≥18 and ≤28 kg/m², and a body weight ≥60 kg exclusion criteria: * history or current evidence of specified diseases * history of malignancy in the past 5 years * gain or loss in body weight of more than 5% within the last 2 months or use of weight-loss medication within the last 3 months * ecg abnormalities of clinical relevance * suspected hypersensitivity to the trial medication * positive virology tests indicating acute or chronic infections * clinically relevant laboratory parameters outside a specified range * use of specified medications within certain time frames or use of certain co-medications * abuse of alcohol or drugs * dietary habits that would prevent from taking standardised meals * female subjects: positive pregnancy test; lack of medically reliable methods of contraception during the trial * donation of blood * smoking within the last 3 months
comparison of vildagliptin vs. glimepiride on glucose variability in metformin uncontrolled type 2 diabetic patients

Conditions: Type 2 Diabetes Mellitus

Summary: compare the effect of vildagliptin plus metformin versus glimepiride plus metformin on glucose variability in t2dm patients.


Eligibility criteria:
inclusion criteria: 1. patients who have given written informed consent to participate in the study. 2. type 2 diabetes mellitus patients either male or female from 18 - 75 years of age (both inclusive). 3. patients who are uncontrolled on metformin monotherapy for at least past 4 weeks (1000-1500 mg daily and hba1c \> 7.5 - 9%). 4. patients with hba1c levels within the range \> 7.5% - 9%. (if a past value is available within the last 12 weeks, it would be considered acceptable provided it was obtained after at least 4 weeks of metformin therapy 1000-1500 mg daily). exclusion criteria: 1. age \> 75 years ; bmi \ 40 kg/m2 2. patients who are on insulin therapy at the time of study entry. 3. type 1 diabetes mellitus patients. 4. patients with severe renal (creatinine clearance \ 3 x uln). creatinine clearance will be estimated from serum creatinine using cockcroft-gault formula (cockcroft and gault, 1976) 5. patients with contraindications as mentioned in the summary of product characteristics (spcs) for vildagliptin, metformin, glimepiride, vildagliptin plus metformin and glimiperide plus metformin. other protocol defined inclusion/exclusion criteria may apply.

Keywords: type 2 diabetes mellitus, glycemic variability
the role of acupuncture for the treatment of obstructive sleep apnea in patients with hypertension

Conditions: Sleep Apnea, Obstructive

Summary: recent evidences from small studies show potential benefit of acupuncture in the treatment of obstructive sleep apnea (osa). these studies did not evaluate the benefit of the treatment on the cardiovascular system. primary end-point: to investigate the effects of acupuncture in improving osa severity among hypertensive patients. secondary end-point to investigate the effect of acupuncture in improving the quality of life and sleep assessed by the short form 36 (sf-36) questionnaire and pittsburgh questionaire (psqi); to investigate the effect of acupuncture in blood pressure and arterial stiffness


Eligibility criteria:
inclusion criteria: * 5\<apnea-hypopnea index (ahi)\<30 e/h exclusion criteria: * body mass index \> 35 kg/m2 * previous osa treatment

Keywords: acupuncture
efficacy of hypopressive exercises versus pilates in women with abdominal diastasis in the postpartum period: a randomized controlled trial

Conditions: Abdominal Diastasis

Summary: the aim of this study is to compare the effects of two exercise programs in women with abdominal diastasis (ad) during the postpartum. one group will receive hypopressive exercises (he) and the other will receive pilates exercise. the hypothesis of this study is that the execution of both protocols will offer benefits in the ultrasound values of the ad and in the data collected on the quality of life in the short term and 12 weeks after its completion.

objective: to compare the efficacy of hypopressive exercises (he) versus pilates exercise in women with abdominal diastasis (ad) during the postpartum, and to know the effects of each of the exercises independently. design: single-blind randomized controlled trial. setting: faculty of physical therapy of alcalá de henares (uah). participants: primiparous women with da who have vaginal delivery and are in the 3 months postpartum (n=40). interventions: participants will be randomly assigned to perform either a he program focused on freediving work (n=20) or a pilates program focused on exhalation (n=20). the intervention will consist of 3 weekly sessions lasting 30 minutes over 12 weeks, where they will receive a weekly face-to-face and group session and two home sessions. main outcome measures: the primary outcome will be measurement of the distance between rectus abdominis through ultrasound to be assessed at baseline, immediately after the intervention and 12 weeks later. the secondary outcome measure will correspond to the measurement of quality of life using the sf-36 health questionnaire. it will be collected through masked evaluations by 2 physiotherapists at baseline, at the end of the intervention and at 12 weeks.

Eligibility criteria:
inclusion criteria: * primiparous women over 18 years of age who are within 3 months postpartum. * ad with values \&gt;2.5 cm in any of the following reference points: 2 cm supraumbilical or 2 cm infraumbilical. * vaginal birth. exclusion criteria: * abdominal or umbilical hernia. * previous abdominal surgery. * be receiving any other treatment for your ad

Keywords: hypopressive exercise pilates abdominal diastasis postpartum
prospective cohort study of the risk of recurrent atrial fibrillation after radiofrequency ablation

Conditions: Atrial Fibrillation

Summary: in this study, the continuous inclusion of atrial fibrillation patients treated by catheter ablation in the department of cardiology, peking university third hospital, through the collection of clinical data and outpatient follow-up, to explore the risk factors of atrial fibrillation recurrence after catheter ablation and the influencing factors of major clinical events in atrial fibrillation patients, and further guide the management mode of atrial fibrillation patients.


Eligibility criteria:
inclusion criteria: * 1) age \> 18 * 2) ecg or holter electrocardiogram confirmed atrial fibrillation exclusion criteria: * 1) hematological diseases, autoimmune diseases and malignant tumors * 2) immobility caused by hemiplegia or severe trauma * 3) the expected survival time is less than 2 years * 4) poor compliance and high risk of expected loss of follow-up * 5) disorders of consciousness or alzheimer's disease
evaluation of a mobile digital solution for cancer care and research

Conditions: Cancer; Caregivers; Quality of Life

Summary: the primary purpose of this pilot study is to evaluate the feasibility and acceptability of a mobile digital solution in monitoring and collecting symptom burden data. the proposed study is meant to be the preparatory work for an intervention study to test the effect of mobile digital solutions on improving patient outcomes by prompting early interventions for symptom relief and support of patient and family caregiver quality of life (qol).

demographic information and patient-reported symptoms will be collected from study participants through a mobile health application called cancerlife that they can download (free) from their mobile device app store (android or ios). participants will be asked to broadcast their emotional and physical status through a list of symptom list within the app as well as how that symptom is impacting their quality of life and activities of daily living. this data will be collected inside the application and display in easy to understand pie charts. participants will also have the option to broadcast their entry to their social network. since the objective of the current feasibility study is to evaluate the feasibility and acceptability of a mobile digital solution in monitoring and collecting symptom burden and qol data, the investigators will include a standard validated instrument (fact-g: functional assessment of cancer therapy - general) as part of this study. participants will be asked to complete the fact-g after initial registration and weekly for up to 4 weeks. participants will receive electronic mail messages with a link to cancerlife weekly as a reminder to access the website.

Eligibility criteria:
inclusion criteria: * established diagnosis of cancer * karnofsky index ≥50% * age \> 18 years exclusion criteria: * relevant cognitive impairment * insufficient knowledge of english language to complete the survey
aprepitant/mk0869 for prevention of chemotherapy induced nausea and vomiting associated with cisplatin (0869-169)(completed)

Conditions: Chemotherapy-induced Nausea and Vomiting (CINV)

Summary: this study will demonstrate and confirm the efficacy and safety of mk0869 for the treatment of chemotherapy-induced nausea and vomiting in chinese patients.


Eligibility criteria:
inclusion criteria: cycle 1: * patient is scheduled to receive his/her first course of cisplatin chemotherapy at a dose of at least 70 mg/m\^2 administered a maximum of 3 hours * patient has a predicted life expectancy of at least 3 months * patient is not pregnant cycle 2 (optional): * participation in the study during the next cycle of chemotherapy is considered appropriate by the investigator and will not pose unwarranted risk to the patient. * satisfactory completion of the preceding cycle of chemotherapy and related study procedures. * patient will continue to receive the same chemotherapy regimen as in cycle 1. the cisplatin dose may be reduced in subsequent cycle, as long as the new dose is still no less than 70 mg/m\^2. exclusion criteria: cycles 1 \& 2: * patient will receive stem cell therapy in conjunction with cisplatin * patient has an active infection or any uncontrolled disease (e.g. diabetes) * patient will receive multiple-day chemotherapy with cisplatin * patient will receive chemotherapy of moderate or high emetogenicity on the 6 days prior to cisplatin infusion or the 6 days following the cisplatin infusion * patient has vomited within 24 hours prior to cisplatin infusion * patient received or will receive radiation therapy to the abdomen

Keywords: cinv
athrectomy and drug eluting balloon therapy (adebt) on the femoral popliteal arteries

Conditions: Peripheral Arterial Disease

Summary: the aim of this study is to study the effects of athrectomy followed by percutaneous transluminal angioplasty using paclitaxel coated drug eluting balloon (deb) in treating de novo or re-stenotic lesions in the femoral-popliteal artery in patients with symptomatic peripheral vascular disease in an asian population. the intention is to study the effects of debulking athrectomy followed by application of debs to prevent restenosis, resulting in improved patency rates the study will prospectively recruit 8 cases treated with athrectomy followed by deb. this project is a pilot to investigate the effects of athrectomy and deb in reducing re-stenosis rates. it will be a primer for a larger scale randomized controlled trial (rct) involving multiple institutions to demonstrate the benefit of athrectomy and deb technology to treat de novo versus plain balloon angioplasty with bail-out stenting, which is currently the most commonly used modality to treat femoral-popliteal lesions. there are no studies combining the effect of rotational athrectomy and debs.

patient will undergo an intervention under anaesthesia. after common femoral artery sheath access, a diagnostic angiogram will be performed. after pre-arthrectomy intravascular ultrasound (ivus) of the affected arterial segment, patient will undergo treatment of the lesion with arthrectomy, followed by post-arthrectomy ivus analysis. following arthrectomy, the affected vessel will be treated by supplementary ranger drug eluting balloon (deb). during post-procedure, patients will be started on dual antiplatelets for 3 months followed by aspirin for life unless contraindicated. clinical follow-up, duplex ultrasound (to assess for re-stenosis) and ankle brachial pressure index (abpi) will be performed at 1-month, 6-month and 12-month post intervention. assessment of the symptoms, pulse, and clinical patency will be performed at each visit.

Eligibility criteria:
inclusion criteria: * symptomatic ≥ 50% stenosis or occlusions of the femoral or popliteal artery (including below knee popliteal artery) proven on 2 views during angiography of rutherford stage 2-6 lesions * at least one tibial vessel runoff * life expectancy \>1 year exclusion criteria: * subintimal recanalisation of the affected de novo artery which would preclude treatment with athrectomy * patient unwilling or unlikely to comply with follow-up schedule * gfr \<30 ml/min * planned major index limb amputation * acute limb ischaemia * untreated ipsilateral iliac artery stenosis ≥ 50 * previous atherectomy, brachytherapy or cryoplasty of the affected arterial segment * severe flow limiting dissection or residual stenosis \>50% post initial athrectomy requiring supplementary stenting * female patients of childbearing potential
deep brain stimulation effects in essential tremor

Conditions: Essential Tremor

Summary: deep brain stimulation (dbs) is an effective therapy for patients with medically refractory essential tremor. however, dbs programming is not standardized and multiple clinic visits are frequently required to adequately control symptoms. the investigators aim to longitudinally record brain signals from patients using a novel neurostimulator that can record brain signals. the investigators will correlate brain signals to clinical severity scores to identify pathological rhythms in the absence of dbs, and we will study the effects of dbs on these signals in order to guide clinical programming.

the development of newer technologies has allowed clinicians and researchers to better understand pathophysiological underpinnings of different disorders managed with neuromodulation. the is now the ability to stream brain signals from a newly fda approved device, the medtronic percept. the investigators will study the longitudinal effects of dbs on the brain signals that are found to correlate with tremor severity as measured with wireless wearable sensors.

Eligibility criteria:
inclusion criteria * patient gives an informed consent. * patient is over 21 years of age. * having a diagnosis of a essential tremor confirmed by a trained movement disorders neurologist; * having failed or not tolerated conventional medical management, at the discretion of the neurologist managing the patient; exclusion criteria * having alternative diagnoses to essential tremor; * having comorbid neurodegenerative disorders that may affect mobility or cognition (e.g. comorbid parkinson's disease or dystonia); * having sequelae of prior brain insult (e.g. prior stroke or brain tumor); * history of prior resective brain surgery (e.g. tumor resection); * not being a dbs candidate; * receiving unilateral implants * having a higher surgical risk that precludes patient from having standard intraoperative mapping.
a study of real-world outcomes of people with crohn's disease (cd)

Conditions: Crohn Disease

Summary: the main aim of this study is to compare long-term remission in participants receiving vedolizumab (vdz) and those receiving ustekinumab (ust). in this study, the study doctors will review each participant's past medical records. this study is about collecting existing information only; participants will not receive treatment or need to visit a study doctor during this study.

this is a non-interventional, retrospective study of participants with cd. the study will review the medical charts of participants who have initiated the treatment with vedolizumab and ustekinumab or another biologic agent (post- index). the study will aim to enroll approximately 700 participants, with 350 participants in each of the following cohorts: * cohort 1: vedolizumab * cohort 2: ustekinumab the data for participants will be collected in two main periods: * pre-index event period: from the date of diagnosis of cd until the date of index when vedolizumab or ustekinumab was initiated during the eligibility period. * post-index event period: from one day post-index when vedolizumab or ustekinumab was initiated during the eligibility period until chart abstraction initiation, unless the date of death or loss to follow-up is before the date of chart abstraction initiation. this multi-center study will be conducted in belgium, australia, and switzerland. the overall time for data collection in the study will be approximately 12 months and the long-term duration of the study is approximately 36 months.

Eligibility criteria:
inclusion criteria: 1. has a diagnosis of cd documented in the medical records. 2. has received at least one dose of vedolizumab or ustekinumab at one of the participating study sites during the eligibility period. 3. was biologic-naïve (no prior biologic use for any pathology, including cd) at the time of index event. 4. has completed induction phase and has a minimum of a six-month duration between the date of the index event and the date of chart abstraction initiation and was still under active care at the site six months post-index date. exclusion criteria: 1. has received vedolizumab or ustekinumab as part of a clinical trial in their lifetime (includes index event). 2. has initiated index treatment as combination therapy with two biologic agents. 3. has received previous treatment with biologic agents for cd or conditions other than cd ever in their lifetime. 4. has medical chart empty or missing. 5. part or all of the participant's index treatment was received at a different site, and the participant's medical chart pertaining to this care is not accessible. 6. has received a subcutaneous formulation of ustekinumab for induction (that is, a subcutaneous induction dose of ustekinumab prior to ustekinumab's approval for cd in the study countries).

Keywords: drug therapy
the role of endobronchial needle aspiration with rapid on-site evaluation in the diagnosis of central malignant lesions

Conditions: Lung Cancer

Summary: endobronchial lung cancer tend to manifest in three different patterns. it can present as a bulky, exophytic mass lesion, submucosal infiltration or extrinsic compression from peribronchial disease. bronchoscopy with differents techniques as forceps biopsy, bronchial brushing and bronchial washing is recognized as the gold standard to diagnose central airways lung neoplasms. some authors suggested that the addition of endobronchial needle aspiration (ebna) to these conventional diagnostic methods may increase the sensitivity of bronchoscopy in submucosal and peribronchial disease but few prospective trials have been performed and this procedure is still underutilized in many centers. rapid on-site evaluation (rose) showed to improve yield of transbronchial needle aspiration (tbna) of mediastinal nodes and pulmonary peripheral lesions, reducing the number of inadequate specimens and costs. however, its utility during endobronchial needle aspiration has not been substantiated. this prospective study has two primary objectives: to compare the sensitivity of rose-ebna with that of the conventional technique and to investigate the diagnostic yield of endobronchial needle aspiration and its contribution to cdm in the evaluation of patients with endobronchial lesions.


Eligibility criteria:
inclusion criteria: * consecutive adult patients with a suspected central lung cancer at a chest ct scan who need a bronchoscopy for diagnostic purposes exclusion criteria: * presence of uncontrolled coagulopathy, preexisting known malignancies, and the refusal to sign an informed consent

Keywords: endobronchial needle aspiration (ebna) transbronchial needle aspiration (tbna) rapid on-site evaluation (rose) lung cancer