Kornimate/medical-research-clean huggingface dataset:
safety, tolerability and abeta-specific antibody response of repeated i.m. injections of adjuvanted cad106 in mild alzheimer patients

Conditions: Alzheimer's Disease

Summary: this study will assess the safety, tolerability and abeta-specific antibody response of repeated intra-muscular injections of adjuvanted cad106 in patients with mild alzheimer's disease.


Eligibility criteria:
inclusion criteria: * male and/or female patients below 85 years of age (inclusive) * diagnosis of mild alzheimer's disease * mini-mental state examination (mmse) 20 to 26 (inclusive) at screening, untreated or on stable dose of cholinesterase inhibitor or memantine over the last 4 weeks prior to clinical assessments exclusion criteria: * previously participated in an ad vaccine study and received active treatment * history or presence of an active autoimmune disease * history or presence of seizure disorder * presence of significant coronary heart disease and/or cerebrovascular disease * presence of other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression) * advanced, severe, progressive or unstable disease that might interfere with the safety, tolerability and pharmacodynamic assessments of the patient other protocol-defined inclusion/exclusion criteria may apply

Keywords: active immunization alzheimer disease antibody central nervous system diseases neurodegenerative diseases vaccine
clinical pre-screening protocol for ovarian cancer

Conditions: Ovarian Cancer

Summary: the pre-screening study is established to pre-screen tumor samples from ovarian cancer patients to identify if they, at a later stage of their disease, will benefit from treatment with any investigational cancer drugs available to oncology venture, when these drugs are approved for future clinical studies by local authorities.


Eligibility criteria:
inclusion criteria: * patients with histological confirmed epithelia ovarian cancer * relapse after 2 or more chemotherapies for ovarian cancer * ffpe tumor tissue available exclusion criteria: * other primary malignancy within the last 5 years prior to enrolment
prevalence of rest dyspnea and impact of non invasive ventilation on breathing sensations in cchs patients

Conditions: CCHS; Congenital Central Hypoventilation Syndrome; Dyspnea

Summary: congenital central hypoventilation syndrome (cchs) is a neuro-respiratory disease characterized by lifethreatening sleep-related hypoventilation involving an alteration of co2/h+ chemosensitivity. this suggests cortical activity during awakening to maintain breathing. cortical activity to keep breathing is usually associated with breathing discomfort ; this is the case in healthy subjects under non invasive ventilation (niv) or with expiratory charge as well as in patients with amyotrophic lateral sclerosis. this can suggest that cchs may be breathless at rest and this discomfort could be reduced by niv. the objective is to evaluate dyspnea with a multi dimensional score, mdp, in cchs patient at rest in every day life and during 1h session of niv. the investigators will perform a prospective, including 20 cchs patients. mdp scores will be measure before and after 1h-non invasive ventilation as well as a visual scale of 100mm in order to evaluate variation of breathing discomfort before/after niv. the investigators expect that cchs patients don't have rest dyspnea but niv would improve breathing discomfort that would mean they have latent rest dyspnea.


Eligibility criteria:
inclusion criteria: * patients with cchs confirmed by genetic test * patients with long term non invasive ventilation * no recent condition that could impact breathing sensations such as infection, pulmonary embolism, heart failure exclusion criteria: * pregnancy * phrenic nerve stimulation
the efficacy of oral antiseptics against covid-19

Conditions: COVID-19

Summary: in a study conducted on 75 covid-19 patients, the effect of sars-cov-2 on viral load was investigated as a result of the use of hypochlorous acid and povidone-iodine as an oral antiseptic.

before and 30 minutes after rinsing with mouth antiseptics, the participants were asked to rinse the mouth and throat for 30 seconds with 0.9% isotonic saline. the sample was sputtered into a sterile plastic container. the participants were grouped according to the type of oral antiseptics used. the effectiveness of sars-cov-2 viral load was investigated by rinsing the mouth and throat for 30 seconds with 20 ml of hypochlorous acid, povidone-iodine, and isotonic saline. viral load was analyzed by rt-pcr analysis. the results were evaluated by statistical analysis.

Eligibility criteria:
inclusion criteria: * positive sars-cov-2 rt-pcr result, * adult hospitalized patient, * the participants have the physical and psychological ability to follow the instructions in the study. exclusion criteria: * patients intubated and supported by a mechanical respirator, * severe acute or chronic medical or psychiatric condition, * history of significant adverse effects following use of oral hygiene products such as toothpaste and mouth rinses, * active uncontrolled thyroid disease, * developmental/cognitive disability, * pregnancy, * undergoing radioactive iodine therapy.

Keywords: covid-19 viral load antiseptic povidone-iodine hypochlorous acid
the effects of eccentric-focused exercise on posterior shoulder tightness in symptomatic overhead athletes

Conditions: Posterior Shoulder Tightness

Summary: the aim of this study is to investigate the effects of shoulder eccentric exercise training on shoulder mobility, rotator cuff strength, pain and dysfunction, scapular kinematics and muscle activation in symptomatic overhead athletes with posterior shoulder tightness.

overhead athletes commonly have posterior shoulder tightness due to repetitively high tensile loading during overhead throwing. however, intervention studies focused on posterior shoulder tightness in people with subacromial pain are still limited. additionally, eccentric exercise was thought to improve the eccentric strength and neuromuscular control of posterior shoulder muscles to endure repetitively eccentric loading, which may improve posterior shoulder tightness and decrease the risk of subacromial pain. nevertheless, no previous study investigated the influence of eccentric exercise on posterior shoulder tightness in overhead athletes. the aim of this study is to investigate the effects of shoulder eccentric exercise training on shoulder mobility, rotator cuff strength, pain and dysfunction, scapular kinematics and muscle activation in symptomatic overhead athletes with posterior shoulder tightness.

Eligibility criteria:
inclusion criteria: * participate in overhead sports over 4 hours per week * age between 20 to 50 years old * glenohumeral joint range of motion deficit: shoulder internal rotation loss more than 15 degrees compared to the non-dominant side and total arc of motion loss more than 5 degrees or/and horizontal adduction range of motion lo more than 15 degrees compared to the non-dominant side * shoulder impingement syndrome criteria exclusion criteria: * history of shoulder dislocation, fracture and operation * history of direct contact in upper extremities or cervical region in the past one month * shoulder pain or neurological symptom caused by cervical problem * vas more than 5 during shoulder elevation * receive treatment for posterior shoulder tightness in the past 3 months

Keywords: posterior shoulder tightness eccentric exercise shoulder impingement syndrome
a primary care-based psychosocial intervention to improve cognitive & depression outcomes in older adults with mci & early stage ad

Conditions: Depression; Pain; Cognitive Impairment

Summary: the purpose of the study is to examine the effect of problem adaptation therapy for pain (path-pain) on cognitive functioning, depression and pain-related disability in 100 older adults with cognitive impairment, chronic pain, and depression. the study will test if path-pain has better cognitive, affective, and functional outcomes than attention control usual care.

this is a randomized control trial to target cognition in older adults with mci or early ad, depression, and chronic pain with a psychotherapeutic intervention in primary care. this project will study the efficacy of 8 in-office acute treatment sessions (first 8 weeks) and 6 telephone delivered sessions (3 individual and 3 group) in the following months (from 9-36 weeks) of path- pain vs. an equal number of sessions consisting of attention control usual care in improving cognitive, affective, and functional outcomes. each therapy session will last approximately 50 minutes. assessments will be conducted at study entry and weeks 5, 9 (end of acute treatment; includes assessment of cognitive functioning), 24, 36 (end of follow-up treatment; includes assessment of cognitive functioning) and 52 (includes assessments of cognitive functioning) after randomization. this is an efficacy trial, but by being delivered by certified mental health clinicians, it has a strong "real-world" focus.

Eligibility criteria:
inclusion criteria: * age ≥ 60 years old * mci or early stage probable or possible ad diagnosis (as defined by albert et al or mckhann et al) al). patients will have at least mild cognitive deficits defined by 16 ≤ moca ≤ 25. * montgomery asberg depression rating scale (madrs)\[55\] total ≥ 5, which reflects at least some mild depressive symptoms. * participants will be off antidepressants, cholinesterase inhibitors or memantine or on a stable dosage for at least 12 weeks. * chronic pain (neuropathic, nociceptive or mixed disorders): presence of pain on most days for at least 3 months and average pain intensity score \>=4. * clinical dementia rating 0.5 ≤ (cdr) ≤ 1. * participant will have capacity to consent. * participation of a study partner (e.g. caregiver/family member/significant other) is required. exclusion criteria: * deemed to have a significant suicide risk as assessed by site pi and clinical team. * deemed too unstable medically or neurologically to safely enroll in a research trial. * deemed too psychiatrically unstable to safely enroll in randomized trial of psychotherapy. * requiring psychiatric hospitalization at baseline for safety. * lack of english fluency.

Keywords: older adults mild cognitive impairment early stage alzheimer's disease
internal mammary lymph nodes irradiation in high-risk breast cancer after neoadjuvant chemotherapy

Conditions: Breast Cancer

Summary: the aim of this study is to explore the impact of internal mammary nodal irradiation on disease-free survival in high-risk breast cancer patients (ypn+or supra/subclavicular lymph node positive) after neoadjuvant chemotherapy.

this is a prospective, randomized phase 3 trial. breast cancer patients with axillary lymph node-positive or supra/subclavicular lymph node metastasis underwent neoadjuvant chemotherapy were included. patients underwent regional nodal irradiation along with breast or chest wall irradiation and randomly allocated to either imni or no imni.

Eligibility criteria:
inclusion criteria: * histologically confirmed invasive breast cancer * underwent neoadjuvant chemotherapy * eastern cooperative oncology group performance status scale 0-2 * ypn+ after neoadjuvant chemotherapy or supraclavicular/subclavicular lymph node metastasis before system therapy * no distant metastases * no internal mammary nodes metastases based on images before system therapy * willing to follow up * written,informed consent exclusion criteria: * without neoadjuvant chemotherapy * distant metastases * simultaneous bilateral breast cancer * pathological confirmation or imaging consideration of lymph node metastasis in the internal mammary before system therapy * had simultaneous or previous secondary malignancies, except for non-malignant melanoma skin cancer, papillary thyroid / follicular carcinoma, cervical carcinoma in situ, contralateral non-invasive breast cancer

Keywords: breast cancer internal mammary nodal radiation
efficacy studies of corticosteroid therapy in community-acquired pneumonia

Conditions: Pneumonia

Summary: the purpose of this study is to determine the efficacy of addition of corticosteroid therapy to antibiotics in patient admitted with community-acquired pneumonia. the hypothesis is: prednisolone in combination with antibiotic treatments is effective in improving clinical outcome in patients hospitalized with cap.

community-acquired pneumonia (cap) is a acute illness with a considerable morbidity and mortality, especially patients with severe cap. in the past decennia, in spite of many investigations, little reduction is seen in morbidity an mortality. corticosteroids have a immune-modulation effect, which is not completely elucidated. most likely the immune modulation effect is due to down-regulation of pro-inflammatory cytokines. the use of corticosteroids next to antibiotics in cap could lead to shorter time to clinical stability, length of stay and costs. comparison: hospitalized patients with cap treated with antibiotics and prednisolone versus hospitalized patients with cap treated with antibiotics and placebo

Eligibility criteria:
inclusion criteria: clinical symptoms of community-acquired pneumonia: * fever, cough, sputum, pleural pain, dyspnoea * radiological symptoms of pneumoniä exclusion criteria: * any conditions wich requires corticosteroid therapy. * pregnancy of lactation * malignancy * immune-compromised patients (eg chemotherapy or aids) * pre-treatment with macrolide for \>24 hours

Keywords: pneumonia corticosteroids
head pulse for ischemic stroke detection

Conditions: Acute Ischemic Stroke

Summary: accurate diagnosis of stroke due to large vessel occlusion (lvo) is an essential step in providing acute stroke care to a community. the gold-standard for diagnosis lvo is brain imaging, which is impractical in the pre-hospital setting. a non-invasive method to detect lvo is needed. using highly sensitive accelerometers, one can measure the "headpulse"- tiny forces exerted on the skull from the cardiac contraction. this study tests the hypothesis that lvo alters the headpulse characteristically. analysis of these data along with the subjects vascular status (lvo vs. non-lvo as measured by ct angiography) will be used to create a model that can predict lvo status in suspect stroke subjects.

large vessel occlusion (lvo) ischemic stroke is a treatable disease at specialized centers. clinical outcomes of patients with lvo is time-dependent. to maximize clinical benefit of thrombectomy, stroke systems of care need accurate methods to triage patients with lvo to comprehensive stroke centers or thrombectomy ready centers rather than closer primary stroke centers. episode will evaluate whether measurements of the headpulse can predict the presence or absence of lvo based on recordings from a consecutive series of patients undergoing cta for suspected stroke. recordings from patients pre- and post-thrombectomy will also be compared to investigate whether a systematic change in cranial forces exists during lvo.

Eligibility criteria:
inclusion criteria: * suspected acute stroke * cta or mra performed exclusion criteria: * any patient in whom obtaining a non-invasive recording is judged by the treating team to interfere with clinical assessment or treatment of the patient.
collection of samples for the evaluation of wound biofilm in acute and chronic wounds

Conditions: Wounds

Summary: the specific aim of examining wounds microscopically is to attempt to demonstrate the presence of biofilm in chronic wounds and to understand these populations on a cellular level.

characterizing the surface of the acute wound is important because the characterization can act as a control and can give a standard by which to judge the microscopic pathology observed in chronic wounds.

Eligibility criteria:
inclusion criteria: * the subject must be 18 years of age or older. * the subject must have a full thickness acute or chronic wound. the sampling is restricted to subjects with the presence of a full thickness wound in order to reduce any risk for infection to the subject. biopsying a wound that is already full thickness should not increase the subject's risk. * the subject must have no history of coagulopathy * if the subject's acute wound will be biopsied, the wound must be less than 48 hours old. * the subject must be a candidate for sharp debridement exclusion criteria: * the subject may not have myelosuppression indicated by a cbc which may include a wbc less than 1500 cells per cubic millimeter, platelet count less than 125,000 per cubic millimeter, or hemoglobin less than 9 g/dl. * the subject may not be on anticoagulation therapy because anticoagulation therapy increases the risk of bleeding. * the subject may not have a tcpo2 less than 20 torr. subjects with low tissue oxygenations may have some risk from biopsy due to their poor ability to heal and, therefore, are excluded. * the subject may not be pregnant * the subject's wound must not be in the region of the face, neck, or genitalia

Keywords: acute wounds and chronic wounds
an image-guided sbrt for adrenal gland metastasis in oligometastatic patients

Conditions: Adrenal Gland Metastases

Summary: the study is designed to to assess the efficacy of ablative sbrt delivered with vmat technique in oligometastatic patients affected by adrenal gland metastases.

this is a phase ii, single arm, trial for testing efficacy of ablative high hypofractionated dose delivered with vmat technique in oligometastatic patients with adrenal gland metastases. the potential advantages of this approach include the possibility to lead an increased local control in irradiated adrenal gland metastases. other purpose of this study is to assess acute and late toxicity in terms of maintenance of endocrine mechanisms of hormonal production.

Eligibility criteria:
inclusion criteria: * age ≥ 18years. * who performance status ≤ 1 (ecog - kps). * histologically-proven of primary cancer disease * metastases at adrenal gland radiologically proven * written informed consent exclusion criteria: * prior radiation to the interested adrenal gland. * patients allergic to contrast used in ct scans or who cannot be premedicated for the use of contrast.
a study of ro5045337 in combination with cytarabine in patients with acute myelogenous leukemia

Conditions: Myelogenous Leukemia, Acute

Summary: this multi-center, open-label, phase 1b study will evaluate the safety, pharmacokinetics and efficacy of ro5045337 in combination with cytarabine in patients with acute myelogenous leukemia. in arm a, cohorts of previously untreated patients deemed unsuitable for standard induction therapy will receive escalating oral doses of ro5045377 and cytarabine 20 mg/m2 subcutaneously daily for days 1 to 10 of each 28-day cycle. in arm b, cohorts of patients who have relapsed or are refractory after at least one cytarabine/anthracycline containing regimen will receive escalating oral doses of ro5045377 on days 1 to 5 and cytarabine 1 gm/m2 intravenously on days 1 to 6 of each 28-day cycle. patients will receive up to 4 cycles of therapy, patients in arm a who achieve hematologic response may continue additional cycles until disease progression.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * patients with histologically or cytologically documented acute myelogenous leukemia appropriate for cytarabine therapy including: * arm a: patients who have not received prior standard induction chemotherapy, considered unsuitable for standard induction therapy * arm b: patients who have failed their 1st or greater line of standard induction chemotherapy (primary refractory) or patients who originally achieved a complete response but are currently in first or greater relapse * eastern cooperative oncology group (ecog) performance status 0 to 2 * all non-hematological adverse events of any prior chemotherapy, surgery, or radiotherapy must have resolved to nci-ctc ae grade \</=2 * adequate hepatic and renal function * patient must be willing to submit the blood sampling and bone marrow sampling for pk and pd analyses and exploratory biomarkers exclusion criteria: * history of allergic or toxic reactions attributed to cytarabine or a history of allergic reactions to components of the formulated product * current evidence of cns leukemia * any severe and/or uncontrolled medical condition or other conditions that could affect the participation in the study * pregnant or breastfeeding women * hiv-positive patients receiving combination anti-retroviral therapy
coronary computed tomography (ct) to measure coronary calcification in spinal cord injury (sci)

Conditions: Spinal Cord Injury

Summary: although conventional risk factors for coronary heart disease (chd) have been identified and routinely used to determine risk for chd in the general population, a systematic approach to determine population-specific risk for chd has not been performed prospectively in those with sci. chd is a leading cause of death in spinal cord injury, occurring at younger ages than in the able-bodied population. conventional risk factors for chd are high serum concentrations of low-density lipoprotein (ldl), low serum concentrations of high-density lipoprotein (hdl), diabetes mellitus (dm), positive smoking history, and positive family history of premature chd. coronary calcification (cac) is a commonly occurring phenomenon that does not necessarily indicate significant obstructive disease. studies have shown that a strong association exists between coronary calcification and coronary heart disease. the purpose of this study is to compare the cac scores in persons with sci with a historical control group of able-bodied persons from a national data base who will be matched for conventional risk factors for coronary artery disease (cad) and to determine the relationship between cac scores and conventional and emerging risk factors for cad.


Eligibility criteria:
inclusion criteria: 1. male or female, 18 to 70 years of age; 2. chronic (e.g., duration of injury at least 6 months), stable sci (regardless of level of lesion or completeness of injury); 3. concurrently participating in or previously completed protocol # 0454-06-073, "risk factors for coronary heart disease in spinal cord injury: conventional and emerging". exclusion criteria: 1. acute medical illness; 2. pregnancy (as determined by a pregnancy test \< 1 week of the study); and 3. the presence of a chronic disease (i.e., heart disease, pulmonary disease, etc.); 4. inability to comply with breathing instructions.

Keywords: spinal cord injury coronary artery disease
psychological status and related factors of thyroid related eye disease

Conditions: Thyroid Related Eye Disease

Summary: the purpose of this study is to evaluate the psychological status of thyroid related eye disease.

the purpose of this study is to evaluate the psychological status of patients of thyroid related eye disease over 16 years old, and to analyze the related factors of them.

Eligibility criteria:
inclusion criteria: * over 16 years old * diagnosed as thyroid related eye disease exclusion criteria: * any uncontrolled clinical problems

Keywords: psychological status related factors thyroid related eye disease