Kornimate/medical-research-clean huggingface dataset:
trabecular bone score in multiple sclerosis

Conditions: Multiple Sclerosis; Endocrine System Diseases; Neurologic Disorder

Summary: assess bone quality in ms patients through tbs and evaluate the potential effects exerted by different drugs used in ms treatment, which may affect bmd and tbs in ms patients


Eligibility criteria:
inclusion criteria: * diagnosis of ms according to the latest revision of mcdonald's criteria; * patients with relapsing-remitting ms (rrms), secondary progressive ms (spms) and primary progressive ms (spms); * absence of cortisone therapy for at least 6 months; exclusion criteria: patients already being treated with anti-osteoporotic drugs; • medical conditions that preclude the execution of the densitometric examination
low-dose/metronomic(ldm)chemotherapy for metastatic breast cancer

Conditions: Chemotherapy; Breast Cancer, Metastatic

Summary: low-dose metronomic(ldm)chemotherapy as well as anti-inflammatory agents and bisphosphonates have shown anti-angiogenic properties on tumor vasculature. this study is meant to test the therapeutic potential of an anti-angiogenic treatment strategy by combining all these agents for metastatic breast cancer patients.


Eligibility criteria:
inclusion criteria: * histologic proof of infiltrating duct carcinoma of breast. * her-2 negative tumors. * ecog performance status: 0-1. * presence of measurable disease: primary and/or metastatic. * cbc showing normal values or any toxicity limited to grade i. * sma showing liver and renal functions \< 1.5 normal values * previous treatment with an anthracycline and with a taxane is mandatory either as neoadjuvant/adjuvant treatment or for metastatic disease. * previous treatment by chemotherapy for metastatic disease is allowed (up to three lines, allowing for mtd capecitabine to be one of them). * previous treatment by a bisphosphonate is allowed. however,those patients who up to the study had not received any bisphosphonate and those who had received clodronate- will receive pamidronate; those who had been under pamidronate- will receive zoledronate; those who had been under zoledronate- will continue with it." * the patient's signature on the informed consent. exclusion criteria: * her-2 neu positive tumor * inability to visit the clinic for outpatient treatment and evaluation * active/symptomatic brain metastases. * ecog performance status: 2-4. * presence of hand -foot syndrome, at grade \> 2. * cbc with any grade \>2 toxicity * sma showing liver functions \> 1.5 normal values * sma showing renal functions \> normal values -current continuous treatment by steroids or by nsaids, or by anti- coagulants for "non protocol" reasons. * presence of exclusively non-measurable disease (i/e: exclusive bone disease with non-representative tumor markers). * previous radiotherapy to the "only measurable disease". * pleural or peritoneal effusion that may represent a "third space". * history of active peptic ulcer. * symptomatic coronary heart disease.

Keywords: metronomic chemotherapy anti-angiogenic effect breast cancer
etoposide+cytarabine+peg-rhg-csf for hematopoietic stem cell mobilization in patients with hematological malignancies

Conditions: Hematological Malignancy

Summary: this is a single-arm, multicenter, exploratory clinical study to evaluate the safety and efficacy of the combination of etoposide, cytarabine and peg-rhg-csf (eap regimen) on hematopoietic stem cell mobilization in poor mobilization patients with hematological malignancies. all eligible patients will receive eap regimen treatment, then the number of cd34+ cells and white blood cells will be monitoring. when the collection standard is met, hematopoietic stem cell collection will be started.


Eligibility criteria:
inclusion criteria: 1. according to the diagnostic criteria of the italian transplantation working group, patients with multiple myeloma or lymphoma diagnosed as "confirmed poor mobilization" or "predicted poor mobilization". 2. patients with auto-hsct indication. 3. eastern cooperative oncology group (ecog) performance status of 0\~2. 4. patients should be within age range of ≥18 and ≤75 years old. 5. life expectancy ≥ 3 months. 6. patients must be able to sign informed consent. exclusion criteria: 1. patients with severe cardiac, hepatic or renal insufficiency, such as: * cardiac function class ii or higher or severe arrhythmia; * serum direct bilirubin (dbil)\>2× upper limit of normal (uln); * aspartate aminotransferase (ast) or alanine aminotransferase (alt) \> 2× uln; * serum creatinine clearance rate≤50%. 2. patients with active infection. 3. history of allergy to etoposide (vp-16), cytarabine (ara-c), or peg-rhg-csf. 4. women who are pregnant or breastfeeding. 5. have received live vaccine and attenuated live vaccine within 4 weeks before enrollment. 6. for any other reasons, the patients are believed not suitable for participation in this study by investigators

Keywords: etoposide cytarabine peg-rhg-csf hematological malignancies hematopoietic stem cell mobilization
a study of tak-662 for japanese patients with congenital protein c deficiency

Conditions: Congenital Protein C Deficiency

Summary: pharmacokinetic part: this study is for japanese participants with congenital protein c deficiency. the main aim of this study is to check how much tak-662 stays in their blood over time. this will help the study sponsor (takeda) to work out the best dose to give patients in the future. participants will receive 1 single infusion of tak-662. they will stay at the clinic until 3 days after the infusion. then, participants will return to their clinic 7 days after the infusion to check side effects from the study treatment. extension part: participants who will complete the pk part will be given an opportunity to continue tak-662 administration as 3 different treatment options (on-demand therapy, short-term prophylaxis, and long-term prophylaxis) in the extension part, until the commercial protein c concentrate is available at each study site or study termination.


Eligibility criteria:
inclusion criteria: pk part: 1. male and female participants with japanese nationality. 2. a diagnosis of congenital protein c deficiency (homozygous or compound heterozygous). 3. asymptomatic participant. 4. oral anticoagulants allowed to be received. extension part: 1. participants who participated in the pk part of this study (tak-662-1501). 2. participant who are; a. diagnosed with pf, cisn/wisn, and/or other acute thromboembolic episode for on-demand treatment only; b. requiring treatment with tak-662 for short-term prophylaxis for surgical procedures; c. requiring treatment with tak-662 for long-term prophylaxis. exclusion criteria: pk part: 1. current or recurrent disease that could affect the action, or disposition of the investigational product (ip), or clinical or laboratory assessments. 2. a body weight less than 8 kg. 3. serious liver dysfunction, judged by the investigator. 4. any thrombosis within 2 weeks prior to administration of the ip. 5. other investigational product than tak-662 received within 60 days prior to the administration of the ip. 6. current or relevant history of physical or psychiatric illness, or any medical disorder that may require treatment or make the participant unlikely to fully complete the study, or any condition that presents undue risk from the ip or procedures. 7. current use of any medication (including over-the-counter, herbal, or homeopathic preparations) that could affect (improve or worsen) the condition being studied, or could affect the action or disposition of the ip, or clinical or laboratory assessment. 8. known or suspected intolerance or hypersensitivity to the ip, closely-related compounds, or any of the stated ingredients. 9. known history of alcohol or other substance abuse within the last year. 10. within 30 days prior to the first dose of ip, a participant has been enrolled in a clinical study (including vaccine studies) that, in the investigator's opinion, may impact this sponsored study. extension part: 1. new serious medical conditions which could affect participant's safety or treatment were observed during participation in the pk part of this study (tak-662-1501).
investigation of the ringer perfusion balloon catheter (ringer ptca)

Conditions: Coronary Stenosis

Summary: the objective of this study is to demonstrate safe and effective use of the ringer perfusion balloon catheter for dilatation/pre-dilatation of coronary stenoses during percutaneous coronary intervention (pci).

a prospective, multicenter, single-arm clinical study. the study will be conducted in 3 to 5 investigational sites in the us and canada and will enroll up to 60 participants. the population for this study is adult participants undergoing non-emergent percutaneous coronary intervention (pci) as a stand-alone procedure or following non-emergent diagnostic angiography performed during the same procedure.

Eligibility criteria:
inclusion criteria: * male and female subjects \>18 years old. * patients undergoing clinically indicated non-emergent pci as a stand-alone procedure or in combination with diagnostic angiography during the same procedure. * study target lesion characteristics: a) native de-novo coronary stenosis of at least 70% visually estimated stenosis, or at least 50% visually estimated stenosis and shown to be physiologically significant by flow-mediated criteria (ffr \<0.80, ifr \<0.91); b) estimated reference vessel diameter 2.0-4.5mm; c) lesion length \<25mm; d) calcification not greater than mild. * per investigator assessment, the patient may benefit from inflation distal perfusion during balloon inflation. examples include, but are not limited to: (i) lv systolic dysfunction with lvef\<50% by any modality; (ii) a territory subtended by the target vessel downstream from the target lesion that is estimated to be in excess of 25% of viable lv mass; (iii) prior hemodynamic or electrical instablility during intervention on the target lesion; (iv) the potential to avoid placement of a coronary stent if a stent-like result can be achieved through prolonged balloon inflation. * female subjects of childbearing potential must have a negative pregnancy test per standard of care for pci and be practicing contraception. * informed consent provided. exclusion criteria: * hemodynamic or arrhythmic instability within 48 hours or a myocardial infarction within 72 hours of pci. * more than 2 lesions planned during index pci. * procedural complication developing prior to pci of study target. * ejection fraction (ef) \<25%. * creatinine clearance (cr-cl) \<25 mg/dl. * baseline flow at study target \<timi-2.
study of guselkumab versus placebo for the treatment of low body surface area moderate plaque psoriasis

Conditions: Moderate Plaque Psoriasis

Summary: the purpose of this study is to evaluate the efficacy of guselkumab compared to an inactive drug in participants with low body surface area moderate plaque psoriasis and special site involvement.


Eligibility criteria:
inclusion criteria: * all participants must have a diagnosis of plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before first administration of study intervention * all participants must meet the following disease severity criteria at screening and at baseline: (a) overall investigator's global assessment (iga) 3 (moderate) plaque psoriasis; (b) body surface area (bsa) 2-15 percent (%) with at least 1 plaque outside of special sites; (c) involvement of at least 1 special site with at least moderate severity. qualifying sites include scalp with scalp-specific iga greater than or equal to (\>=) 3, face with facial psoriasis iga \>=3, intertriginous with intertriginous psoriasis iga \>=3, or genital with static physician global assessment of genitalia (spga-g) \>=3 * all participants be inadequately controlled with or intolerant of at least 1 prior topical therapy (including, but not limited to, corticosteroids, retinoids, vitamin d, or vitamin d/steroid and retinoid/steroid combinations, tacrolimus, pimecrolimus, anthralin/dithranol, coal tar preparations, tapinarof, roflumilast, etcetera) for the treatment of psoriasis at both screening * all participants be a candidate for phototherapy or systemic treatment for psoriasis exclusion criteria: * has a nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular) at screening or randomization * has current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium) * for participants with palmoplantar involvement, confounding diagnoses, including, but not limited, to palmoplantar pustulosis, eczematous dermatitis, contact/irritant dermatitis, acquired keratoderma, etcetera, should be confirmed and excluded * participants will not be eligible if they have ever received prior biologic (or biosimilars of) for the treatment of psoriasis, psoriatic arthritis (psa), or any other indications that could impact the assessment of psoriasis. prior biologics (or biosimilars of) may include, but not limited to, tumor necrosis factor (tnf)-inhibitors (for example: adalimumab, etanercept, infliximab, or certolizumab or biosimilars), interleukin (il)-17 inhibitors (for example: secukinumab, ixekizumab, brodalumab, or bimekizumab), and il-12/23 inhibitors (for example: ustekinumab), or il-23 inhibitor (for example: guselkumab, risankizumab or tildrakizumab) * has a history of chronic or recurrent infectious disease, including, but not limited to, chronic renal infection, chronic chest infection (for example, bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic non-remitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers
the effect of dexmedetomidine and licodaine on acute postoperative pain in gynecological laparoscopy

Conditions: Gynecologic Disease

Summary: the aim of this study is to investigate the effect of opioid-free anesthesia using dexmedetomidine and lidocaine instead of remifentanil infusion, on the acute postoperative pain after the gynecological laparoscopy

this study is performed to investigate the effect of dexmedetomidine and lidocaine the postopeative pain, shivering, nausea and vomiting after the gynecological laparoscopy.

Eligibility criteria:
inclusion criteria: * patients scheduled for elective gynecological laparoscopy exclusion criteria: * emergent surgery * cancer surgery * chronic pain requiring pain killers * psychiatric disease * preoperative bradycardia (hr \< 50 bpm) * allergies * pregnancy or breast feeding
act-csp for family caregivers of palliative care patients

Conditions: Caregiver Burden

Summary: the goal of the study is to test the feasibility, acceptability and preliminary efficacy of an acceptance and commitment therapy for supporting caregiver programme (act-csp) on reduction of caregiver burden, anxiety and depressive symptoms and enhancement of caregiving self-efficacy, resilience and quality of life by act when compared to usual care, for caregivers of palliative care patients.

this study will employ a pilot randomized controlled trial recruiting caregivers of palliative care patients to receive either a 3-week acceptance and commitment therapy for supporting caregiver programme (act-csp) plus usual care (n = 15) or usual care only (n = 15). the components of acceptance and commitment therapy process will be emphasized in the intervention programme, which include perspective taking, self-as-context and defusion (i.e. recognizing worry thoughts as thoughts only), identifying values and acceptance of present-moment experience with respect to the values, and committed action. the act-csp will be delivered by a trained act facilitator. participants will be followed up at week 6 and week 8 after recruitment to collect data for assessing the study objectives.

Eligibility criteria:
inclusion criteria: * aged ≥ 18; * self- or patient-identified as a family caregiver of an adult patient receiving palliative care at the study site * have been taking care of the patient in the past 3 months; * able to communicate in cantonese at the time of recruitment; * have access to internet and videoconferencing device such as mobile phone; * have caregiver burden as measured by caregiver strain index (csi) ≥ 7. exclusion criteria: * mentally incompetent (mini-mental state examination (mmse) \< 23), * participating in regular psychosocial interventions.

Keywords: palliative care caregiving acceptance and commitment therapy
preprocedural fasting and nitrous oxide -oxygen inhalation analgesia for dental treatment of children

Conditions: Vomiting

Summary: nitrous oxide analgesia is used routinely for the dental treatment of anxious or uncooperative pediatric patients. in many instances it is used alone without any supplemental oral premedication. a controversy exists among pediatric dentists and pediatric dental departments regarding the need to apply pre-procedural fasting (pf) or other limitations on children undergoing dental treatment with nitrous oxide alone.the purpose of this study is to investigate the association between pf and the frequency of vomiting in pediatric patients receiving dental treatment with nitrous oxide analgesia.

materials and methods the experimental protocol will be submitted for approved by the institutional human subjects ethics committee of hadassah-hebrew university school of dental l medicine. informed consent will be obtained from all parents or legal guardians of participating subjects. subjects all pediatric patients attending the graduate student pediatric dental clinic of the department of pediatric dentistry at hadassah clinic in need of at least two restorative treatment sessions with the use of nitrous oxide will be included. all participants must be in good health (asa i). prior to one session subjects will be restricted and have a preprocedural fasting as per the following guidelines: all subjects will be without solids (including milk) for at least 4 hours prior to nitrous oxide administration and without clear liquids 2 hours before treatment. on the alternative session subjects will have no restrictions on their food or liquid intake. evaluation a survey will be given to parents prior to treatment and information regarding the following will be gathered: age, previous nitrous oxide experience, history of vomiting or nausea (motion sickness, foods etc), last mea: what and when? the resident administering treatment will record the following: duration of inhalation administration, percentage of nitrous oxide and flow rate, steady or fluctuating, occurrence of vomiting during or immediately following treatment. statistical analysis of data will determine the incidence of vomiting and if any significant differences between the two sessions exist.

Eligibility criteria:
inclusion criteria: - all pediatric patients attending the graduate student pediatric dental clinic of the department of pediatric dentistry at hadassah clinic in need of at least two restorative treatment sessions with the use of nitrous oxide will be included. all participants must be in good health (asa i). exclusion criteria: -
identification, molecular epidemiology angiosarcoma of the liver france

Conditions: Angiosarcoma

Summary: the purpose of this study is to test the feasibility of identifying incident cases of angiosarcoma of the liver from the network netsarc.

the study involves a questionnaire and a one-hour telephone interview. consultation: * study proposal * information and collection of the patient's and/or parent's written consents * blood collection (10ml) and urine collection of the patient and parents if applicable * delivery of a specific questionnaire and a stamped envelope (with the address of the coordinator's center). if it's about a child patient or an adolescent under 18 years, 3 questionnaires will be given (1 for each parent and 1 for the child). at home: filling the questionnaire by the patient and/or the parents, alone at home and return to the coordinator via the given envelope. during the study: collect of the initial biopsies used for the hepatic angiosarcoma's diagnostic. end of the study: telephone interview cra/patient and/or parents to complete the questionnaires (around one hour). from this data will be reconstitute the residential process of the patient and parents if it's about a child or an adolescent (collection of the successive addresses). finally, water collections, according to a defined sampling protocol, at the tap of the different homes and places visited by the patients will be organized by the invs in relation to the ars within the scope of water quality controls, in order to evaluate the exposition to vinyl chloride monomer (vcm) by hydric ways.

Eligibility criteria:
inclusion criteria: * any patient with angiosarcoma of the liver (angiosarcoma immediately multifocal allowed) diagnosed by histology from the start of the study * the patient's written consent no exclusion criteria
registry of food allergy oral immunotherapy treatment

Conditions: Food Allergy

Summary: the purpose of this patient registry is to demonstrate safety and efficacy of food oral immunotherapy in food allergic patients. factors that lead to adverse reactions will be identified. the frequency of rescue epinephrine use will be recorded.

each participating us clinic is assigned a site number and patients starting food oral immunotherapy will be given a four digit number starting at 0001 within each site. all data will be collected and reported electronically at each clinical site.

Eligibility criteria:
inclusion criteria: * a history of an allergic reaction following exposure to the food and positive in-vivo or in-vitro sensitivity testing to the food, * no prior exposure to the food, but markedly high in-vitro specific immunoglobulin e (ige) to the food exclusion criteria: * pregnancy * severe asthma * poorly controlled atopic dermatitis * eosinophilic esophagitis

Keywords: food anaphylaxis peanut anaphylaxis food oral immunotherapy food allergy food allergy treatment
prospective analysis of the feasibility of the pascal spacer technology for transcatheter mitral valve repair in an all-comers cohort

Conditions: Mitral Regurgitation

Summary: to identify changes on mitral valve morphology and functionality by the application of the pascaltm in mr.

transcatheter mitral valve repair (tmvr) in mitral regurgitation (mr) is increasingly applied in patients on high surgical risk. interventional mitral valve repair can be applied is routinely applied in primary and secondary mitral regurgitation. while the edge-to-edge technique has been the solely available technlology in the marked for the last years, the recently introduced pascaltm technology represents a novel concept and is characterized by a central spacer, wider paddles, and larger dimensions. implications of implantation of the pascaltm device on the mitral valve morphology and functionality concerning potential changes on mitral regurgitation as well as changes on mitral valve orifice area are to date not fully understood. the current study will identify anatomical changes to optimize ideal patient selection and optimal treatment approaches of the pascaltm device.

Eligibility criteria:
inclusion criteria: • all patients who undergo tvmr for mr (age \>18yrs) at the pi´s site exclusion criteria: * \<18yry * subject does not provide full consent