Kornimate/medical-research-clean huggingface dataset:
memantine - communication study

Conditions: Alzheimer's Disease

Summary: the study objective is to evaluate the effects of memantine treatment on communication abilities and other cognitive abilities in moderate to severe dat patients.


Eligibility criteria:
inclusion criteria: * male or female outpatient at least 50 years of age and at least 8 years of education. * the patient should have german as a mother-tongue or at least speak the language fluently in order to achieve similar scores in verbal tasks. * current diagnosis of probable alzheimer's disease consistent with nincds- adrda criteria or with dsm iv tr criteria for dementia of the alzheimer's type. * mini mental state examination (mmse) total score is less than 20 * patients treated with any acetylcholinesterase inhibitor (achei) may be included, when treatment has started at least 6 months prior screening and was stable during the last 3 months. exclusion criteria: * any type of evident aphasia, which may interfere with patient's communication difficulties caused by alzheimer's disease * history of severe drug allergy, or hypersensitivity, or patients with known hypersensitivity to amantadine, lactose. * evidence (including ct/mri results) of any clinically significant central nervous system disease other than alzheimer's disease. * modified hachinski ischemia score greater than 4 at screening. * current evidence of clinically significant systemic disease * known or suspected history of alcoholism or drug abuse within the past 10 years. * previous treatment with memantine or participation in an investigational study with memantine.
remotion: a trial to investigate the feasibility and potential effectiveness of a blended, transdiagnostic intervention for symptom reduction and improvement of emotion regulation in an outpatient psychotherapeutic setting

Conditions: Mental Disorders

Summary: emotion regulation has been identified as an important transdiagnostic factor in the treatment of mental health disorders. this study aims to examine, for the first time, remotion, a novel blended therapy intervention aimed at reducing symptom severity and improving emotion regulation of patients in an outpatient psychotherapy setting. remotion is an internet based intervention that is administered as an add-on to psychotherapy. this study aims to investigate feasibility and also potential effectiveness of remotion in an outpatient setting. participants will be randomly assigned to the study conditions. outcomes are assessed at baseline, after six weeks and after twelve weeks.


Eligibility criteria:
inclusion criteria: * 18 years or older * in psychotherapeutic treatment at the outpatient clinic of the department of clinical psychology at the university of bern * mental disorder present * internet access available * written informed consent exclusion criteria: * current participation in another intervention, outside of the treatment at the outpatient clinic, that is geared specifically at emotion regulation * current or history of psychotic disorders or bipolar disorder * acute suicidality * insufficient mastery of german language

Keywords: transdiagnostic blended therapy internet-based emotion regulation
deep brain stimulation of the cuneiform nucleus for levodopa-resistant freezing of gait in parkinson's disease

Conditions: Parkinson Disease

Summary: the purpose of this research study is to determine if dbs is a safe and effective therapy for severe freezing of gait in patients with parkinson's disease. freezing of gait (fog) is a particularly debilitating motor deficit seen in a subset of patients with parkinson's disease (pd).


Eligibility criteria:
inclusion: 1. confirmed parkinson's disease according to movement disorder neurologist with documented exclusion of other disorders such as fronto-temporal dementia (ftd)/ frontal gait disorder/normal pressure hydrocephalus (nph)/progressive supranuclear palsy (psp) 2. pd stage3 on medication, with severe gait dysfunction and predominant axial symptoms: movement disorder society-unified parkinson's disease rating scale tremor dominant (mds-updrs td), postural instability gait difficulty (pigd) ratio ≤ 0.90 and freezing of gait questionnaire (fogq) score \> 12. 3. age 40-75 with good response to levodopa (defined as greater than 20% improvement in updrs score) 4. fog refractory to levodopa\>600 mg 5. 6. minimal tremor, bradykinesia, and rigidity symptoms, or well controlled with levodopa and/or with already implanted stn/gpi dbs. 6. a) poor candidate for stn or gpi dbs due to good control of tremor, bradykinesia, and rigidity symptoms with levodopa b) or post-operative stn/gpi dbs pd patients with significant residual non-levodopa responsive postural and gait instability 7. must agree to full 6-month participation in study. exclusion: 1. individuals with major executive dysfunction 2. individuals with dementia, as defined by the mattis dementia rating scale-2 (drs-2) score ≤ 130 3. individuals with other neurocognitive impairments 4. individuals who have depression, as defined for example by the beck depression inventory ii (bdi-ii) \> 25 5. presence of major medical co-morbidities and other surgical contra-indications such as coagulopathy 6. individuals who require diathermy, transcranial magnetic stimulation (tms), or electroconvulsive therapy (ect) 7. individuals with a history of prior intracranial surgery 8. individuals with a metallic implant in their head that is not mri compatible (e.g., aneurysm clip, cochlear implant) 9. individuals with active implantable devices anywhere in the body (e.g. cardiac pacemaker, defibrillator, spinal cord stimulator, implanted medication pump) 10. individuals who are pregnancy or desire to become pregnant during the study 11. individuals who are breastfeeding12. 12. individuals who are on investigational drugs and any other intervention (not part of the guidelines for management of parkinson's disease) known to have a potential impact on outcome 13. subjects utilizing recreational drugs at the time of screening will be excluded from the study with the exception of medicinal marijuana
human umbilical cord mesenchymal stem cell transplantation in articular cartilage defect

Conditions: Cartilage Diseases; Osteoarthritis

Summary: the purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(huc-msc) for articular cartilage defect of knee.

human articular cartilage has limited repair potential.cell-based strategies have explored chondrocytes and mesenchymal stem cells (mscs) with extensive basic science and preclinical studies.however the concept of autologous chondrocyte implantation is not ideal,so the focus in cartilage repair is shifting toward mesenchymal stem cells. to investigate the effects of huc-msc treatment for articular cartilage defects, 20 patients will be enrolled and receive 4 times of huc-msc transplantation.

Eligibility criteria:
inclusion criteria: * patients must consent in writing to participate in the study by signing and dating an informed consent document * healthy patients with no major history of illness * patients must have a diagnosis of osteoarthritis by radiographic criteria of kellgren and lawrence grade 2-4 * patients who needs invasive interventions of arthroplasty due to no response from existing pain medication * patients must have had more than grade 4 (0\~10 point numeric scale) pain at least for four months * patient's damaged cartilage area should be in the range of 2-6cm2 exclusion criteria: * pregnant women or lactating mothers * patients who have received any anti-inflammatory drugs including herb-drug within 14 days * patients who received any drug by intra-articular injection for treatment within 2 months prior to this enrollment * patients with positive human immunodeficiency (hiv) at screening indicative of current of pass infection * impaired liver function, abnormal blood coagulation, combine other tumor or special condition * patients who had participated in other clinical trials within three months prior to this study

Keywords: human umbilical cord mesenchymal stem cell mesenchymal stem cell osteoarthritis
mindfulness-based stress reduction (mbsr) program combined with endurance exercise training: a help in treatment for breast cancer

Conditions: Breast Cancer

Summary: integrative approaches to promote wellness and reduce the distress associated with cancer are considered as essential components of cancer care. in case, exercise training has been shown to produce many positive physiological and psychological benefits. mindfulness-based stress reduction program shows similar beneficial effects, and especially in emotional distress management. the aim of the study is to examine the cumulative effect of an 8 week-exercise-training program combined with an mbsr program on cardio-respiratory fitness and quality of life in women with breast cancer. these effects are thought to be mediated in part through changes in underlying brain processes, that investigators will be put in light. through telomerase activity, oxidative stress, mitochondrial respiration and blood cytokine level measurements, investigators could expect to better understand the effect of these combined training in breast cancer.


Eligibility criteria:
inclusion criteria: * breast cancer * having completed the chemotherapy period * undergoing radiotherapy and/or hormono therapy exclusion criteria: * regular physical activity higher than 4 hours per week. * any disease cardiac, respiratory, neurological or articular disease, which counteract the muscular training )

Keywords: exercise capacity mindfulness quality of life
biologic versus synthetic mesh for treatment of paraesophageal hernia

Conditions: Hiatal Hernia

Summary: the investigators propose a randomized, single blinded controlled trial to compare the use of synthetic versus biologic mesh in hiatal hernia repair, two currently accepted standard of care surgical modalities. the investigators hypothesize that use of synthetic mesh will have lower recurrence at these time points compared to use of biologic mesh.

patients will be randomized to either a synthetic (light weight synthetic or biologic (small intestinal submucosa ) mesh group. endpoints will be measured up to 5 years for the study as a whole, at 6 months and at 60 months. prior to and following laparoscopic paraesophageal hernia repair, patients will be followed with both subjective and objective measures. subjective evaluation will include symptomatic/quality of life assessment at 1-, 6-, 24-, and 60- month periods; objective evaluation will include upper gi study /ph probe study for symptomatic patients and for all patients at 6 and 60 months. the investigators hypothesize that use of synthetic mesh will have lower recurrence at these time points compared to use of biologic mesh.

Eligibility criteria:
inclusion criteria: * male or female gender * age\>18 years * absence of chronic medical conditions that will affect the quality of life survey, such as fibromyalgia, sle, crohn's disease, etc. * able to give informed consent * able and willing to participate in follow-up evaluations * upper gi with a documented hiatal hernia greater than 5cm * paraesophageal hernia with clinically relevant symptoms such as heartburn, chest pain, regurgitation, dysphagia, postprandial abdominal pain, shortness of breath, or early satiety. exclusion criteria: * previous surgery of the esophagus and/or the stomach * emergent operation for acute gastric volvulus or strangulation * biopsy consistent with malignancy * body mass index (bmi) over 35kg/m2 * inability to perform primary closure of crura * active smoking

Keywords: hiatal hernia, recurrence, biologic mesh, synthetic mesh
phase i study of intravenous artesunate for solid tumors

Conditions: Solid Tumors

Summary: this is a phase one study to determine the safety, tolerability, and maximum tolerated dose of intravenous artesunate in patients with solid tumors. a rapid dose escalation design will be used, in which single patients will be enrolled to escalating dose levels until a grade 2 or higher toxicity occurs during cycle 1. enrollment will then continue using 3 to 6 patients at each dose level until a dose is reached at which 2 or more patients out of 6 experience a treatment-related toxicity.

a rapid dose escalation design will be used, in which single patients will be enrolled to each dose level until a grade \>/= 2 treatment-related toxicity occurs during cycle 1; enrollment then will proceed using a classic 3+ 3 dose escalation design. if the toxicity was grade 2, then enrollment will continue on that dose level. if the toxicity was grade 3 or 4, then enrollment will continue on one dose level below that dose. dose escalation with the 3+3 design will continue until \>/= 2 patients out of 6 experience a treatment-related dose-limiting toxicity. then, the maximum tolerated dose and recommended phase ii dose of intravenous artesunate will be one dose level below the level at which the toxicities occurred.

Eligibility criteria:
inclusion criteria: * at least one measurable lesion by recist criteria * willing to undergo pharmacogenetic testing * over the age of 18 years and able to provide informed consent * no standard of care therapy available which has a proven overall survival benefit * adequate kidney, liver, and bone marrow function * life expectancy of greater than 3 months * ecog performance status less than or equal to 2 exclusion criteria: * chemotherapy or surgery within 4 weeks of treatment start * radiation treatment within 3 weeks prior to treatment start * untreated brain metastases or neurologically unstable cns metastases * any severe or uncontrolled medical condition or other condition which could affect participation in the study including: unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction \</= 6 months prior to study entry * previous diagnosis of alpha- or beta-thalassemia * patients on a medication or herbal therapy known to inhibit cyp2a6, ugt1a9, or ugt2b7 * female patients who are pregnant or breast feeding, or adult patients who are of reproductive potential and are unwilling to refrain from conceiving a child during study treatment * patients unwilling or unable to comply with the protocol, or provide informed consent
intravitreal ranibizumab (lucentis®) for neovascular glaucoma- a randomized controlled study

Conditions: Glaucoma, Neovascular; Ranibizumab

Summary: neovascular glaucoma is a potentially blinding condition characterized by the growth of newvessels at the anterior part of the eye. this growth is driven by the overexpression of a protein called vascular endothelial growth factor (vegf). that happens in diseases such as diabetic retinopathy or venous retinal occlusion, and lead to a fast increase in intraocular pressure (iop). traditional treatment include laser photocoagulation of the retina in order to decrease vegf formation. the investigators postulate that the use of anti-vegf intravitreal injections may accelerate recovery and decrease the need of surgery in cases of neovascular glaucoma.

this is a prospective, randomized controlled study that aims to evaluate the efficacy of ranibizumab (lucentis®) as an adjunct in the treatment of patients with neovascular glaucoma. 28 patients with neovascular glaucoma (14 in the study group and 14 in the control standard of care group) will be recruited at a single center- university of sao paulo medical school general hospital. a complete ophthalmologic exam will be carried out, including the obtention of an informed consent for eligible patients willing to participate on the study. patients will be randomly assigned to either standard of care- retinal laser photocoagulation and clinical management of intraocular pressure with drops, or standard of care plus intravitreal ranibizumab injections. two injections will be performed 30 days apart. the patients will be followed for 6 months.

Eligibility criteria:
inclusion criteria: * iop greater than 24 mmhg * iris or anterior chamber neovascularization * at least 120 degrees of opened anterior chamber angle exclusion criteria: * visual acuity worse than counting fingers in the fellow eye * no light perception in the treated eye * any ocular infectious disease * use of systemic steroids * lack of media transparency precluding laser photocoagulation * thromboembolic disease * known hypersensitivity to ranibizumab * female participants at childbearing age not using oral contraceptives * use of intravitreal anti-vegf over the last 30 days.

Keywords: glaucoma, neovascular ranibizumab intraocular pressure anti-vegf intravitreal injection
sensorimotor rehabilitation program in improving quality of life in patients with early stage breast cancer

Conditions: Peripheral Neuropathy; Stage I Breast Cancer AJCC v7; Stage IA Breast Cancer AJCC v7; Stage IB Breast Cancer AJCC v7; Stage II Breast Cancer AJCC v6 and v7; Stage IIA Breast Cancer AJCC v6 and v7; Stage IIB Breast Cancer AJCC v6 and v7

Summary: this clinical trial studies how well the sensorimotor rehabilitation program works in improving quality of life in patients with early stage breast cancer. a hand and foot sensory improvement program from occupational and physical therapists may improve patients' function in everyday tasks and overall quality of life.

primary objectives: i. to investigate the effects of an innovative, new sensorimotor rehabilitation program on persons with cancer following taxane-based chemotherapy for early stage breast cancer. outline: patients attend 1 therapy session to receive education and training in the use of the home program. patients then complete exercises over 90 minutes per week for 6 weeks.

Eligibility criteria:
inclusion criteria: * persons with a primary diagnosis of grade 1 or greater peripheral neuropathy of the upper and lower extremities * taxane-based chemotherapy for early stage breast cancer * diagnosis of early stage breast cancer exclusion criteria: * individuals with late stage breast cancer
gemcitabine and celecoxib combination therapy in treating patients with r0 resection pancreatic cancer

Conditions: Pancreatic Cancer; Chemotherapy Effect

Summary: the prognosis of pancreatic cancer is extremely poor, even in those patients who had underwent surgery, the 5-year survival is still less than 10%. current guidelines recommend gemcitabine monotherapy for r0 resection of pancreatic cancer. inflammation plays an critical role in the development and progression of pancreatic cancer. here we intend to assess the synergistic effect of using celecoxib in combination with gemcitabine on the treatment of r0 resection of pancreatic cancer.

we choose those patients who had underwent the r0 resection of pancreatic ductal adenocarcinoma patients, and divided them into two groups randomly, one group patients were given gemcitabine only according the current guidelines, while the other group patients were given gemcitabine combined with the anti-inflammation agent celecoxib. the disease free survivals, drugs related side effects, overall survivals and other endpoints events were recorded and analyzed, to assess the celecoxib could or couldn't synergist the gemcitabine anti tumor effect on r0 resection pancreatic cancer patients.

Eligibility criteria:
inclusion criteria: 1. 18 years old and above. 2. surgery for r0 resection. 3. the gemcitabine chemotherapy regimen was not previously used for the treatment of other malignancies. 4. eastern cooperative oncology group score 0-2 points. 5. blood routine: the neutrophil count is at least 1.5\*10\^9/ml, and the platelet count is at least 100\*10\^9/ml.hemoglobin is at least 80g/l. 6. liver function: bilirubin does not exceed 1.5 times the upper limit of normal; alanine aminotransferase and aspartate aminotransferase does not exceed the upper limit of normal 3 times; kidney function: creatinine ≤ 1.2 mg/dl. exclusion criteria: 1. endocrine carcinoma, acinar pancreatic carcinoma, or cystadenocarcinoma (cystadenocarcinoma). 2. surgery for pancreatic cancer fails to reach the r0 resection criteria. 3. pancreatic cancer received radiotherapy before surgery. 4. malignant brain metastases. 5. there are other serious cancer history. 6. active infection, severe diarrhea. 7. others: those who are allergic to celecoxib; or who are intolerant to celecoxib, require continuous aspirin or non-steroidal anti-inflammatory drugs; similar chemical or biological components and sulfa drugs that constitute the study drug history of allergies; allergies, asthma, and rubella after taking aspirin or non-steroidal anti-inflammatory drugs; pregnancy or breastfeeding; active gastrointestinal ulcer/hemorrhage/perforation; severe mental illness; severe heart failure; past serious cardiovascular thrombotic adverse events, severe hypertensive patients.

Keywords: pancreatic cancer gemcitabine celecoxib r0 resection
krt-232 versus best available therapy for the treatment of subjects with myelofibrosis who are relapsed or refractory to jak inhibitor treatment

Conditions: Primary Myelofibrosis (PMF); Post-Polycythemia Vera MF (Post-PV-MF); Post-Essential Thrombocythemia MF (Post-ET-MF)

Summary: this study evaluates krt-232, a novel oral small molecule inhibitor of mdm2, for the treatment of patients with myelofibrosis (mf) who no longer benefit from treatment with a jak inhibitor. inhibition of mdm2 is a novel mechanism of action in mf. this study will be conducted in 2 phases. phase 2 will determine the krt-232 recommended dose and dosing schedule; phase 3 will test krt-232 vs best available therapy (bat). patients in the phase 3 part of the study will be randomized 2:1 to receive either krt-232 (arm 1) or bat (arm 2). the bat administered will be determined by the treating physician, with the option to "cross-over" to krt-232 treatment after 6 months of bat or if the disease worsens at any time.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of pmf, post-pv mf or post-et mf (who) * high, intermediate-2, or intermediate-1 risk dynamic international prognostic system (dipss) * failure of prior treatment with jak inhibitor * ecog ≤ 2 exclusion criteria: * prior splenectomy * splenic irradiation within 3 months prior to randomization * history of major hemorrhage or intracranial hemorrhage within 6 months prior to randomization * history of stroke, reversible ischemic neurological defect or transient ischemic attack within 6 months prior to randomization * prior mdm2 inhibitor therapy or p53-directed therapy * prior allogeneic stem-cell transplant or plans for allogeneic stem cell transplant * history of major organ transplant * grade 2 or higher qtc prolongation (\> 480 milliseconds per nci-ctcae criteria, version 5.0)

Keywords: navtemadlin