Kornimate/medical-research-clean huggingface dataset:
a quality ensuring project with focus on patients with cardiovascular diseases as well as type 2 diabetes.

Conditions: Heart Diseases; Diabetes Mellitus, Type 2

Summary: the overall objective is to increase the adherence to national guidelines for patients with established cvd and/or type 2 diabetes by means of repeated post-graduate educational meetings and regular evaluation of the optimisation initiatives, demonstrated by improvement of goal attainment in general practice.


Eligibility criteria:
inclusion criteria: * subjects had to meet all of the inclusion criteria to be eligible for enrollment into the study. the following subjects qualify for inclusion in the study: * subjects for whom measurement of total cholesterol, low density lipoprotein (ldl) cholesterol, blood pressure (bp) and glycosylated hemoglobin (hba1c) was planned independently of this observational study and for whom baseline values were or became available. * subjects with known cvd diagnosed \> or = 6 months before inclusion * previous myocardial infarction * ischemic heart disease (stable and unstable angina pectoris) * ischemic apoplexy * peripheral arterial disease * and/or * subjects with t2d diagnosed \> or = 6 months before inclusion * at least 50% of the subjects had to have cvd as the primary diagnosis. it was allowed for a secondary diagnosis to be \<6 months before inclusion. exclusion criteria: * subjects presenting with any of the following were not to be included in the study: * life expectancy of \< or = 2 years * unable/unwilling to understand/follow instructions * taking part in a clinical study involving an investigational drug * followed by a specialist for their cvd and/or t2d at the time of inclusion in the study
raltitrexed in treating children with refractory acute leukemia

Conditions: Recurrent Childhood Acute Lymphoblastic Leukemia; Recurrent Childhood Acute Myeloid Leukemia

Summary: phase i trial to study the effectiveness of raltitrexed in treating children with refractory acute leukemia. drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die

objectives: i. determine the maximum tolerated dose and dose limiting toxicity of raltitrexed given for three weeks to children with refractory acute leukemia. ii. determine the incidence and severity of other toxic effects of this regimen in these patients. iii. determine a safe and tolerable dose of raltitrexed, administered in this manner, to be used in phase ii studies. iv. determine the pharmacokinetics of this regimen in these patients. v. determine if plasma 2' deoxyuridine concentrations are associated with raltitrexed toxicity or pharmacokinetics. vi. evaluate the antitumor activity of raltitrexed against recurrent leukemia. outline: this is a dose escalation study. patients receive raltitrexed intravenously over 15 minutes once weekly for 3 weeks followed by 1 week of rest. treatment continues in the absence of disease progression and unacceptable toxicity. in the absence of dose-limiting toxicity (dlt) in the first cohort of 6 patients treated, subsequent cohorts of 6 patients each receive escalating doses of raltitrexed on the same schedule. if dlt occurs in 2 of 6 patients at a given dose level, then dose escalation ceases and the next lower dose is declared the maximum tolerated dose. patients are followed every 6 months for 4 years, then annually thereafter.

Eligibility criteria:
inclusion criteria: * histologically or cytologically proven acute leukemia (m3 marrow) that is refractory to conventional therapy or for which no effective therapy exists * no cns leukemia * no solid tumors * performance status: karnofsky 50-100% or lansky at least 50 (for infants) * life expectancy: at least 8 weeks * bilirubin less than 1.5 mg/dl * sgpt less than 5 times normal * normal creatinine for age or gfr at least 70 ml/min * no significant systemic illness such as infection * no significant third space fluid collection * not pregnant or nursing * recovered from acute toxic effects of prior immunotherapy * at least 6 months since prior bone marrow transplant with no evidence of graft-versus-host disease * at least 10 days since prior biologic therapy * at least 1 week since prior growth factors * at least 2 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea) and recovered * no concurrent steroids * recovered from acute toxic effects of all prior radiotherapy * at least 2 weeks since prior local palliative radiotherapy (small port) * at least 6 months since prior substantial bone marrow radiation * no other concurrent anticancer therapy or investigational agents * no concurrent nonsteroidal anti-inflammatory agents
vaginal infection study 2

Conditions: Vaginal Infection

Summary: this study will evaluate the efficacy and safety of a vaginal product compared with that of another vaginal product in the treatment of vaginal infections.


Eligibility criteria:
inclusion criteria: * patients must have a clinical diagnosis of vaginal infection. * patients must be post-menopausal, surgically sterilized or using an acceptable form of birth control. exclusion criteria: * patients must not have any other infections * may not be pregnant or nursing * may not be receiving any other antimicrobial therapies or any medications that would interfere with the outcome of the study.
the study of azithromycin switch therapy for treatment of community acquired pneumonia (cap)

Conditions: Community Acquired Pneumonia (CAP)

Summary: azithromycin has high rates of clinical response and eradication, wide spectrum of activity, so we suppose the development of the azithromycin injectable formulation in japan would deliver benefit to patients of community acquired pneumonia.


Eligibility criteria:
inclusion criteria: * 16 years of age or older patients with cap. * patients who were diagnosed as moderate in severity. exclusion criteria: * known or suspected hypersensitivity or intolerance to azithromycin, other macrolides, or ketolides. * hepatic dysfunction (ast, alt, total bilirubin \> 3 times institutional normal). * severe renal dysfunction (creatinine clearance \< 30 ml/min). * patients who have a history of severe heart diseases (4th -degree of nyha). patients who have a congenital or sporadic long qt syndrome, or who are received the drugs with reported qt prolongation. * severe underlying disease.
topical treatment with fresh human milk versus emollient on atopic eczema spots in young children

Conditions: Atopic Eczema

Summary: the aim of this small pilot study is to assess the potential effects and risks of applying fresh human milk locally on eczema spots in children with atopic eczema. this is a split body, controlled, randomized and physician blinded pilot study, of children with atopic eczema with two similar contralateral eczema spots having a mother breastfeeding the child or a sibling. fresh expressed milk and emollient is to be applied on the intervention spot and emollient alone on the control area, three times a day for four weeks. severity and area of the eczema spots is evaluated weekly, and samples from milk and the spots were analysed weekly with respect to bacterial colonisation.


Eligibility criteria:
inclusion criteria: * children with atopic eczema according to hanifin and rajkas criteria with a mother breastfeeding the child or a sibling. * the eczema spots in the treatment and control areas were to be similar in features and extent as well as being localized on contralateral parts of the body. exclusion criteria: * children were excluded if the severity of the eczema spots indicated need for treatment with antibiotics and/or steroids.

Keywords: atopic eczema human milk topical treatment children
effect of shockwaves on fallopian tubes adhesion

Conditions: Fallopian Tube Adhesion

Summary: the purpose of this study is to determine the effect of shock waves on fallopian tube adhesions.

tubal factor infertility accounts for approximately 40% of the cases of female infertility. identifiable causes of tubal infertility are post-infectious tubal damage, endometriosis-related adhesions, and postsurgical adhesion formation. although surgical management is considered as a common choice for treating blocked tubes or adhesion it has many complications such as: infection, creation of more scar tissue, damage to organs and bleeding. shock waves is a modality that exerts an anti-inflammatory action and regenerative effect as well biological model. shock waves can be nowadays considered an effective, safe, versatile, repeatable, noninvasive therapy for the treatment of many musculo-skeletal diseases, and for some pathological conditions where regenerative effects are desirable, especially when some other noninvasive/conservative therapies have failed. for these reasons and complications of surgery, this study aims to examine the effect of shockwaves therapy on fallopian tubes adhesion

Eligibility criteria:
inclusion criteria: * their ages will be ranged from 25 to 35 years old. * their body mass index (bmi) will be less than 35kg/m². * all women will be diagnosed with fallopian tubes adhesion by the physician. * they have regular menstrual cycles. * all patients have secondary infertility and they have previous caesarean section). exclusion criteria: * any gynecological diseases (uterine prolapse, retroversion flexion of the uterus or chronic pelvic pain). * leukemia or tumor (spinal or pelvic tumor). * diabetes mellitus, hypertension, heart diseases, cardiovascular diseases and skin diseases.
chronic postsurgical pain: multivariate prediction model

Conditions: Post Surgical Pain; Post Operative Pain; Postoperative Pain, Chronic

Summary: the goal of this observational study is to identify the risk factors of chronic postoperative pain (or chronic post surgery pain - cpsp) three months after surgery and, subsequently. the development of a risk index to identify high-risk patients considering the multifactorial etiology of cpop in adult patients undergoing any type of elective surgery.

the study aims to identify the risk factors of cpsp three months after surgery and subsequently develop a risk index to identify high-risk patients considering the multifactorial etiology of cpsp. a comprehensive entry pool was derived from a systematic literature search. data collection will record parameters at four different time points: preoperative assessment (60 to 1 day before the scheduled procedure); evaluation of the perioperative period; postoperative period (from the third month after the operation). the outcome variable is the presence of cpsp assessed 3 months postoperatively and defined as a mean pain intensity of at least 3 on the nrs (one-dimensional pain scale from 0 to 10) over the past three days and pain localized to the field surgical (or to the area of the lesion) projected into the innervation territory of a nerve located in this area, or referred to a dermatome. four separate forecasting models will be developed using data derived from surveys carried out at relevant time points for the development of the risk index.

Eligibility criteria:
inclusion criteria: * adult patients * patients undergoing any type of elective surgery exclusion criteria: * patients with sensory impairments * patients unable to communicate * patients with cognitive impairments * patients with insufficent knowledge of the language

Keywords: pain chronic pain postoperative pain post operative pain post surgical pain multivariate prediction model prediction model
reducing lung cancer-related anxiety (relax)

Conditions: Lung Cancer

Summary: the purpose of this research study is to compare the effects of music and different levels of device-guided breathing on anxiety and shortness of breath in lung cancer survivors.

objectives 1. to assess feasibility (accrual, participation, adherence, retention) of a randomized study of device-guided breathing and music in 75 post-treatment lung cancer survivors with significant anxiety. 2. to obtain preliminary data on the variability and efficacy of two doses of a device-guided breathing intervention versus a music control group for reducing anxiety (primary outcome) and for improving self-reported dyspnea and respiratory functioning (secondary outcomes) in post-treatment lung cancer survivors. 3. to select the optimal dose of the device-guided breathing intervention (15 minutes once/day or twice/day) for subsequent randomized study.

Eligibility criteria:
inclusion criteria: * past history of any lung cancer * for stage i-iii disease, patients should be 2-24 months post-completion of surgery, radiation therapy and/or chemotherapy with no further planned treatment during the 12-week study and no evidence of disease. * for stage iv disease, patients may be receiving no treatment or may be receiving maintenance treatment with a target agent, chemotherapy, or immunotherapy provided the most recent imaging does not demonstrate progressive disease. * after completion of all three screening questionnaires, participant must score accordingly on at least one questionnaire to be eligible. * willing/able to attend brief introductory session and use assigned device for the assigned period of time (15 minutes once or twice per day), at least 5 days per week for 12 weeks * age ≥ 18 years * must have telephone exclusion criteria: * patient does not understand english * active lung infection * progressive cancer (must be considered no evidence of disease or stable) * any change in psychotropic medications in past 30 days * hearing loss that would preclude participating in interventions. adequate hearing to participate will be determined via: (1) response of "no" to the question \["do you have a hearing problem now?"\] participants with hearing aids will be allowed to enroll as long as their hearing is adequate to hear the sounds on the study devices. if necessary, potential study participants will receive a brief test trial with the resperate device. if they indicate inability to hear the guiding tones, they will not be enrolled in the study. cortisol exclusion - participants with endocrine disorders (e.g., diabetes and thyroid disorders) or on steroid-based medications are excluded from the cortisol portion of the study (with the exception of topical hydrocortisone that is permitted).

Keywords: anxiety dyspnea respiratory functioning
a phase 2a proof-of-concept trial of bempikibart (adx-914) for the treatment of severe alopecia areata (signal-aa)

Conditions: Alopecia Areata

Summary: part a is a randomized, double-blind, placebo-controlled, multi-center proof-of-concept (poc) trial in subjects with severe alopecia areata. all participants in part a have completed participation. part b is a multicenter, open-label study to assess the efficacy, safety, and tolerability of bempikibart (adx-914) in participants with severe alopecia areata.

part a is a phase iia, randomized, double-blind, placebo-controlled, multi-center proof-of-concept (poc) study in adult subjects with severe alopecia areata (aa). bempikibart (adx-914) or matching placebo is administered subcutaneously in the clinic setting every 2 weeks for 24 weeks, with follow-up for 12 weeks. subjects will be randomized 3:1 to drug vs placebo. all participants in part a have completed participation. part b is a multicenter, open-label study comprised of a screening period of up to 4 weeks, a treatment period of 36 weeks, and a follow-up period of 16 weeks, for a total study duration of up to 56 weeks. open label extension cohort is a multicenter, open-label extension to assess the long-term efficacy, safety, and tolerability of bempikibart (adx-914) in participants with severe aa who experienced hair regrowth as participants in part a of the study. participants enrolled in the open label extension cohort will receive bempikibart (adx-914) for a duration of 6 months followed by a 16-week follow-up period.

Eligibility criteria:
key inclusion criteria: 1. adult men and women, aged 18 to 75 years, inclusive, at the time of informed consent. 2. clinical diagnosis of severe to very severe alopecia areata, defined as the presence of ≥50% total scalp hair loss at screening and baseline as measured by the salt score. key exclusion criteria: 1. history of or diagnosis at screening of any another form of alopecia based on assessment by investigator. 2. history (lifetime) or presence of hair transplants. 3. history (lifetime) or presence of micropigmentation of the scalp (note: microblading of the eyebrows is permitted). 4. use of systemic, topical, or device-based therapy for aa. 5. history of, recent, or current clinically serious viral, bacterial, fungal, or parasitic infection or mycobacterial infection or at risk of serious infection.

Keywords: areata, alopecia alopecia dermatitis hair loss trichoscopy atopic
family planning service delivery integration for hiv positive and at-risk women in botswana: a hybrid type 2 clinical intervention and implementation strategy

Conditions: Family Planning

Summary: the goal of this pilot study is to assess both implementation outcomes (acceptability, feasibility and adoption) and clinical efficacy (contraceptive method uptake by women wishing to avoid pregnancy) using a hybrid type 2 study design of a family planning program being piloted by the cervical cancer prevention program in gabarone, botswana.


Eligibility criteria:
inclusion criteria: 1. female 2. english or setswana speaking 3. receiving ccp services at the clinic 4. 18-45 years of age 5. able to give informed consent to study procedures, as determined by research/clinic staff exclusion criteria: 1. pregnant
initiation and titration of amaryl

Conditions: Diabetes Mellitus, Type 2

Summary: primary objective: * to describe the conditions of initiation and titration of amaryl m, according to previous treatment: * initial dose * titration scheme * efficacy after 4 months assessed by hba1c * tolerability (number and severity of hypoglycaemia) secondary objective: * fasting plasma glucose * weight evolution


Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes who have been treated with a stable dose (any dose) of : * sulfonylurea monotherapy or * metformin monotherapy or * free combination of glimepiride and metformin with a stable dose (any dose) * body mass index (bmi) between 20 and 40 kg/m2 * hba1c superior or egal to 7.5% * fpg superior or egal 7 mmol/l exclusion criteria: * secondary or insulin-dependant diabetes * any severe chronic disease (hepatic, renal impairments) * history of major cardiovascular event in the last 6 months * acute conditions with the potential to alter renal function such as: dehydratation, severe infection, shock, iv administration of iodinated contrast agents * allergy to sulfonylurea, metformin * drug or alcohol abuse * pregnancy, lactation the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
a study of rd14-01 in patients with advanced solid tumors

Conditions: Solid Tumor

Summary: this study will evaluate the safety and tolerability of rd14-01, a ror1-targeted car t-cell therapy, in patients with ror1+ advanced solid tumors.

this single-arm, open-label, dose-escalation and dose-expansion study will evaluate the safety and tolerability of rd14-01, ror1-targeting car t cells, in adults with ror1+ advanced solid tumors. the dose-escalation phase will investigate 3 dose levels to the. the dose-expansion phase will enroll .

Eligibility criteria:
inclusion criteria: 1. age ≥18 years. 2. patients with histologically or cytologically confirmed advanced solid tumor, who have progressive disease, have undergone systemic therapy for advanced disease, and for whom no standard therapy is available. 3. ror1+ by central laboratory immunohistochemistry (ihc). 4. adequate organ and marrow function. 5. at least one measurable lesion as per recist v1.1. 6. . eastern cooperative oncology group (ecog) performance status 0 or 1. 7. ability to understand and provide informed consent. exclusion criteria: 1. prior treatment with any agent targeting ror1 2. presence of active central nervous system (cns) metastasis 3. impaired cardiac function or clinically significant cardiac disease 4. untreated or active infection at the time of screening or leukapheresis 5. hiv-positive, active acute or chronic hbv or hcv, or active tuberculosis 6. untreated or active infection at the time of screening or leukapheresis 7. pregnant or breast-feeding females

Keywords: car-t cell ror1
the impact of pharmacological and electric modulation of nmda pathway on the cognitive flexibility and volitional movement preparation in patients with parkinson's disease

Conditions: Parkinson's Disease With Dementia

Summary: the project will investigate the effect of pharmacological and electric modulation of n-methyl-d-aspartate (nmda) pathway on the cognitive flexibility and volitional movement preparation in patients with parkinson's disease (pd).

sarcosine (also called n-methylglycine) is an endogenous glyt-1 inhibitor. by blocking glycine uptake, sarcosine increases synaptic glycine concentration to enhance nmda receptor function. nmda receptor, a subtype of ionotropic glutamate receptors, serves important functions in the brain, including learning, memory, cognition, and neural plasticity under physiological conditions and contributes to neurodegeneration in pathophysiological processes. nmda receptor represents collectively a group of heteromeric tetramers. every nmda receptor is a protein complex, typically composed of two nr1 subunits and two nr2 subunits that together form the nmda receptor ion channel. it requires two receptor agonists (glutamate for the nr2 binding site and glycine for the nr1 binding site) to open the ion channel for nmda receptor activation. clinically, modulation through the nmda-nr1-glycine site is preferred to avoid the excitotoxicity associated with the glutamate site activation.8 in addition, recent animal studies have shown that dopamine secretion can be enhanced by either blocking the striatal nr2 or by activation of the nmda-receptor glycine site. in the project, we will focus on pharmacological enhancement of nmda-glycine receptor function based on increasing synaptic glycine concentration by sarcosine administration to examine whether enhancing nmda-glycine receptor activity can improve the neuropsychiatric symptoms, cognition and hopefully motor function in pd-d patients

Eligibility criteria:
inclusion criteria: * the diagnosis of pd-d will be based on the criteria proposed by 2007 movement disorders pd-d task force. (emre m et.al. mov disord 2007; 22:1689-1707) exclusion criteria: * acute confusion due to systemic illnesses or drug intoxication. * major depression * features compatible with "probable vascular dementia. * patient who is pregnant.

Keywords: parkinson's disease dementia nmda event related potential bereitschaftspotential