Kornimate/medical-research-clean huggingface dataset:
genetic modulation of working memory in attention deficit hyperactivity disorder (adhd)

Conditions: ADHD

Summary: in this study the investigators will measure the functional brain activity of adult attention deficit hyperactivity disorder (adhd) patients, genotyped according to the comt genotype, during a working memory paradigm, before and after a placebo controlled treatment with mph for 6 weeks. within this design, the investigators will be able to evaluate the therapeutic effect of mph treatment on cognitive functions.


Eligibility criteria:
inclusion criteria: * only participants will be included who (1) fulfil the diagnostic criteria defined in guidelines for the diagnosis of adhd in childhood and adulthood and who (2) would be treated with mph also for clinical indications outside the study. * provision of written informed consent * a diagnosis of a adhd (314.xx) by diagnostic and statistical manual of mental disorders- fourth edition (dsm-iv) * females and males aged 18-50 years * female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (hcg) test at enrolment * able to understand and comply with the requirements of the study * right-handed according edinburgh handedness inventory (oldfield, 1971) * german as first language * caucasian ethnicity exclusion criteria: * pregnancy or lactation; women capable of childbearing are required to use a reliable method (pearl-index \< 1%) of contraception (e.g. hormonal treatment, intrauterine device, vasoligation in the partner, sexual abstinent) * any current dsm-iv axis i disorder not defined in the inclusion criteria requiring current additional treatment * motoric tics, siblings with tics or positive family history or diagnosis of a tourette syndrome * patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others * known intolerance or lack of response to methylphenidate, as judged by the investigator * present pre-treatment with methylphenidate (within the last three month prior to study treatment) * intake of mao-inhibitors within the last 14 days prior to study treatment * medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment * unstable or inadequately treated medical illness (e.g. congestive heart failure / chf, angina pectoris, hypertension, narrow angle glaucoma, hyperthyroidism, thyreotoxicosis, cardiac arrhythmia, cardiac infarction) as judged by the investigator. * epilepsy * an absolute neutrophil count (anc) of minor 1.5 x 10 exp 9 per litre * involvement in the planning and conduct of the study * previous enrolment or randomisation of treatment in the present study * participation in another drug trial within 4 weeks prior to enrolment into this study * moderate, severe, or profound mental retardation * heart pacemakers, cochlea implants, other metal parts in the head outside the mouth
comparison of tp and tac regimens in neoadjuvant treatment of tnbc

Conditions: Triple Negative Breast Cancer

Summary: previous studies have shown that tnbc is sensitive to dna crosslinking-related chemotherapeutic drugs such as platinum. however, there is a lack of large sample prospective clinical data to compare the efficacy of tp and ec-t / tec regimen in the neoadjuvant chemotherapy of tnbc. besides, the application of anthracycline drugs is limited to a certain extent due to the cardiotoxicity. based on the above evidence, the researchers hope to explore a more effective and safer new adjuvant therapy for tnbc.

in this study, tnbc patients were randomly divided into experimental group and control group, the ratio of experimental group to control group was 1:1. the experimental group received 6 cycles of neoadjuvant chemotherapy (docetaxel 75 mg / m2 day 1 + cisplatin 25 mg / m2 day 1, 2, 3), 21 days as a cycle. the control group was treated with tac (docetaxel 75mg / m2 + adriamycin 50mg / m2 + cyclophosphamide 500mg / m2) for 6 cycles, 21 days as a cycle. to compare the efficacy and safety of 6\*tp (docetaxel + cisplatin) regimen and traditional 6\*tac (docetaxel + doxorubicin + cyclophosphamide) regimen in neoadjuvant chemotherapy of tnbc.

Eligibility criteria:
inclusion criteria: 1. age: 18-70. 2. clinical stage ⅱ-ⅲ. 3. triple negative and invasive breast cancer confirmed by histopathology: triple negative breast cancer is defined as: * negative for er and pr (ihc nuclear staining \< 10%). * her-2 negative (ihc 0,1 + without fish, or ihc 2 + and without fish amplification). 4. with clinically measurable focus: measurable lesions observed on ultrasound, mammography, or magnetic resonance imaging (optional) within the month prior to randomization. 5. organ and bone marrow function tests within 1 month before chemotherapy indicate no contraindications to chemotherapy: * neutrophils count absolute value ≥ 2.0×109/l * hemoglobin ≥ 100g/l * blood platelet ≥ 100×109/l * total bilirubin \< 1.5 uln (upline of normal value) * creatinine \< 1.5×uln * ast/alt \< 1.5×uln; 6. cardiac ultrasound ef value ≥ 55%. 7. females of childbearing age with negative serum pregnancy test 14 days before randomization. 8. ecog score ≤1. 9. sign informed consent. exclusion criteria: 1. evidence of metastatic breast cancer (excluding metastatic breast cancer, a chest ct, abdominal ultrasound, or ct and bone scanning should be performed at any time point before diagnosis and randomization; pet/ct scanning can be used as an alternative imaging examination mean) . 2. the patients have received chemotherapy, endocrine therapy, targeted therapy, and radiation therapy for this disease. 3. the patient has a second primary malignant tumor, except for: - thoroughly treated skin cancer 4. due to severe and uncontrollable other medical diseases, researchers believe the existence of chemotherapy contraindications.
efficacy and safety of rasagiline in prodromal parkinson's disease

Conditions: REM Sleep Behavior Disorder; Parkinson Disease; Synucleinopathies

Summary: to investigate whether a year of rasagiline may reduce the progression from idiopathic rem sleep behavior disorder (rbd) to parkinson's disease (pd).


Eligibility criteria:
inclusion criteria: * psg confirmed rbd with subtle motor symptoms (4≤mds-updrs-iii≤10 at baseline) * no clinical diagnosis of parkinson's disease or dementia at baseline * age 30-75 * no concomitant or previous use of any other anti-parkinson medications * provide written informed consent exclusion criteria: * diagnosed with secondary parkinsonism (eg., drug-induced, vascular, psychogenic) * secondary rbd (eg., drug-induced, immune-mediated) * nervous system comorbidities (eg., stroke, epilepsy, encephalitis) * severe psychiatric comorbidities * allergic to rasagiline * severe systemic diseases (eg., end-stage kidney disease, liver failure)
extension study in subjects who relapsed after complete response on study kw-0761-001

Conditions: Peripheral T-cell Lymphoma; Cutaneous T-cell Lymphoma

Summary: this study will enroll subjects with either peripheral t-cell lymphoma (ptcl) or cutaneous t-cell lymphoma(ctcl),including mycosis fungoides (mf) and sezary syndrome (ss), who have relapsed after achieving a complete response in study, kw-0761-001.


Eligibility criteria:
inclusion criteria: * 1. the subject has relapsed after achieving a complete response to treatment with kw 0761 for ptcl or ctcl on study, kw-0761-001. 2. the subject has an eastern cooperative oncology group (ecog) performance status score of \< 2 at study entry. 3. the subject is \>18 years of age. 4. the subject has adequate hematological function: absolute neutrophil count \[anc\] \>1,500 cells/ul and platelets \>100,000 cells/ul,except in patients with known bone marrow involvement where absolute neutrophil count \[anc\] must be \> 1,000 cells/ul and platelets \>75,000 cells/ul. 5. the subject has adequate hepatic function: bilirubin ≤ 1.5 times the specific institutional upper limit of normal \[uln\]; aspartate transaminase \[ast\] and alanine transaminase \[alt\] each ≤ 2.5 x uln or ≤ 5.0 x uln in the presence of known hepatic malignancy. 6. the subject has serum creatinine ≤1.5 x uln or a calculated creatinine clearance \>60 ml/min. 7. subjects with mf and a history of staphylococcus colonization are eligible provided they continue to receive stable doses of prophylactic antibiotics. exclusion criteria: 1. the subject has received any type of treatment for their disease since completing study, kw-0761-001. 2. the subject has a significant uncontrolled intercurrent illness including, but not limited to: uncontrolled infection requiring antibiotics; clinically significant cardiac disease (class iii or iv of the new york heart association \[nyha\] classification); unstable angina pectoris; angioplasty, stenting, or myocardial infarction within 6 months; uncontrolled hypertension (systolic blood pressure \>160 mmhg, diastolic bp \>100 mmhg, found on two consecutive measurements separated by a 1 week period) despite two anti-hypertensive medications; clinically significant cardiac arrhythmia; or uncontrolled diabetes. 3. subjects on any immunomodulatory drug, (other than low dose corticosteroids equivalent to a daily dose of 10 mg of prednisone 4. the subject has a psychiatric illness, disability or social situation that would compromise the subject's safety or ability to provide consent, or limit his or her compliance with study requirements. 5. the subject has experienced allergic reactions to monoclonal antibodies or other therapeutic proteins. 6. subjects with active herpes simplex or herpes zoster. 7. subjects with known autoimmune diseases

Keywords: ptcl ctcl mf ss
impact of bedtime routines on sleep and development in toddlers

Conditions: Sleep; Sleep Disturbance; Child Development

Summary: investigators will recruit up to 100 families (children aged 12.0 to 14.9 months and their primary caregivers) at their scheduled 12-month well child care infant visit at temple pediatric care. the purpose of this randomized controlled trial is to examine the impact of implementation of a bedtime routine program, connect, calm, \& comfort: 3 cs for bedtime zzzs, to promote better sleep and improve developmental outcomes in toddlers from primarily low-income families.

a bedtime routine is a key factor in the promotion of not only healthy sleep, but also potentially of broad development and wellbeing in early childhood. a bedtime routine, in and of itself, embodies the characteristics of nurturing care and early child stimulation especially for at-risk children. it is consistent with the lancet early childhood series steering committee emphasizing the need for nurturing care, which includes adequate health, nutrition, security and safety, responsive caregiving, and early learning opportunities, to help young children (ages 0-5 years) reach their full developmental potential, and to build a strong foundation for subsequent development, health, and wellbeing. common, adaptive components of a bedtime routine can contribute to an array of positive developmental outcomes beyond improved sleep, inclusive of language development, literacy, child emotional and behavioral regulation, parent-child attachment, and family functioning, among other outcomes. although studies have been conducted on the relationship between bedtime routines and sleep, there have been few studies looking at bedtime routines and other developmental outcomes.

Eligibility criteria:
inclusion criteria: * presenting to a well child visit * child between 12.0 to 14.9 months of age * english-speaking * caregiver is legal guardian of infant * caregiver is primary caregiver of infant exclusion criteria: * non-english speaking * absence of primary caregiver at both the 12-month and 15-month well-child visit
a comparison of long-acting injectable medications for schizophrenia

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: the purpose of this research study is to compare the "real-world" effectiveness of two fda-approved and widely used long-acting injectable antipsychotic medications (paliperidone palmitate and haloperidol decanoate) in patients with schizophrenia or schizoaffective disorder who are expected to benefit from the improved medication compliance associated with injectable medications. the goal is to evaluate the effects of the medications on outcomes of importance to patients (relapse, symptoms, adverse effects, functioning) as well as policy makers (all of the above plus costs).

the purpose of this comparative effectiveness research study is to learn more about different medications called antipsychotics that are used to treat schizophrenia or schizoaffective disorder. specifically, we are looking at long-acting medications that are given by injection every month, instead of being taken by mouth every day. in this multi-site study, we are comparing the risk and benefits of two fda-approved long-acting injectable medications (paliperidone palmitate and haloperidol decanoate). study participants with schizophrenia or schizoaffective disorder are expected to benefit from the improved medication schedule. this study aims to enroll 360 individuals with schizophrenia or schizoaffective disorder for whom treatment with a long-acting injectable antipsychotic medication is likely to be helpful. study participants will be randomly assigned to treatment with either paliperidone palmitate and haloperidol decanoate for up to 24 months. participants will have an equal chance of being assigned to each medication, however participants will not know which medication they are taking.

Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia or schizoaffective disorder as defined by dsm-iv-tr criteria * age 18-65 years * capacity to provide informed consent * patients who are likely to benefit from treatment with long-acting injectable paliperidone palmitate or haloperidol decanoate * women of child bearing potential must have a negative serum pregnancy test at the screening visit. exclusion criteria: * patients who are currently stable and doing well on an antipsychotic regimen * patients not expected to benefit from the study medications due to past experience with risperidone, paliperidone or haloperidol * patients with tardive dyskinesia that is moderate or severe * patients with any medical condition that, in the judgment of the investigator, might preclude safe completion of the study * women who are pregnant or breastfeeding * patients with mental retardation
anti-müllerian hormone is not predictive of pregnancy in donor insemination cycles in non-infertile women

Conditions: Infertility

Summary: to evaluate if ovarian reserve (measured by means of anti-mullerian hormone -amh- and antral follicle count -afc-) can predict pregnancy in donor insemination cycles (diui) performed in non-infertile women.


Eligibility criteria:
inclusion criteria: * absence of male partner * complete azoospermia or the presence of a genetic condition in the partner that made the couple opt for donor sperm * absence of previous history of infertility. * d ta on amh and afc assessment before the first diui cycle. exclusion criteria: * previous history of infertility. * presence of any gynaecological condition that could impair the inseminations results: * endometriosis, hydrosalpinx,...

Keywords: donor sperm insemination anti mullerian hormone ovarian reserve antral follicle count
digital preop-planning of total hip arthroplasties

Conditions: Orthopedic Disorder

Summary: residual leg length discrepancy is a common issue after total hip arthroplasty(tha). digital preoperative planning may improve the accuracy of the surgical procedure and may help the surgeon to precisely predict implants sizes

total hip arthroplasties (thas) are used to restore locomotion. more than 150,000 thas are performed each year in france. better outcomes require a restoration of limb lengths and anatomy. post-operative discrepancy is the main cause of complaints and financial compensation in the us after tha. as such, the investigators aim to use preoperative digital planning using traumacad to optimize the restoration of the center of rotation of the hips. preoperative planning are usually performed using anteroposterior standard radiographs, which are scaled to an inaccurate scale. the traumacad system (brainlab®) allows the adjustment of the scales to each patient and the virtual positioning of the implants in order to simulate the intervention for the restitution of the geometrical parameters of the hip.

Eligibility criteria:
inclusion criteria: * being older than18 years, * osteoarthritis as the indication for tha exclusion criteria: * thas after femoral neck fractures, * revision surgery, * major architectural anomaly (bone tumor, prior fracture of the pelvis, hip dysplasia), * patients under legal protection, * pregnancy or breast-feeding

Keywords: osteoarthritis hip total hip arthroplasty leg discrepancy preoperative planning
trans-anal hemorrhoidal dearterialization (thd) vs. hemorrhoidectomy

Conditions: Hemorrhoids

Summary: the purpose of this study is to compare the frequency and severity of postoperative( after surgery) pain between two surgical techniques for treating severe hemorrhoids. the two techniques are called: transanal hemorrhoidal dearterialization (thd) and standard surgical excision (removal) of the hemorrhoids

the thd technique involves using ultrasound equipment to identify the arteries that are feeding blood into the hemorrhoids. once located, stitches are placed around those arteries to cut off the blood supply to the hemorrhoids, which destroys them. in the standard surgical excision technique, the hemorrhoids are removed by cutting them out with a scalpel. both techniques are widely used in many hospitals today. however, there have been no formal studies comparing the two techniques regarding outcomes, particularly regarding pain after the procedure. we plan to enroll 60 patients in this study here at stony brook; 30 patients will have thd and 30 will have the standard surgical excision of hemorrhoids.

Eligibility criteria:
inclusion criteria: patients visiting colorectal outpatient office at stony book medical center, with the diagnosis of 3rd or 4th degree hemorrhoids requiring hemorrhoidectomy will be invited to participate in this study. the diagnosis of hemorrhoids will be established by a colorectal surgeon based on following criteria: 1. physical exam 2. anoscopy or proctoscopy exclusion criteria: 1. first and second degree hemorrhoids 2. recurrent hemorrhoids after previous surgical treatment 3. history of hiv 4. history of inflammatory bowel disease 5. inability to give informed consent due to mental disability 6. age younger than 18 7. history of colon, rectal or anal cancer 8. thrombosed hemorrhoids 9. pregnant women 10. non english speaking patients

Keywords: hemorrhoids thd ferguson
comparison of the effectiveness metformin for deceasing proliferative marker in endometrial cancer cells

Conditions: Metformin; CA Endometrium

Summary: comparison of the effectiveness metformin versus placebo for deceasing proliferative marker ki-67 expression in endometrial tumours when given for 4 weeks before hysterectomy in endometrial cancer cells.

endometrial cancer is one of the most common gynecological cancers. preclinical studies in endometrial cancer (ec) show that metformin reduces cellular proliferation by pi3k-akt-mtor inhibition. the investigators tested the hypothesis that short-term presurgical metformin reduces cellular proliferation in endometrial cancer. however, no good quality of evidence base supports the effectiveness of metformin for deceasing proliferative marker in endometrial cancer.

Eligibility criteria:
inclusion criteria: * women with endometrial cancer who undergoing complete surgical staging and agrees to participate in this study exclusion criteria: * women without diabetes type 1 and 2 * women who have allergy biguanide * women who have hypoglycemic medication * women who have gfr \<45 ml/min/1.73 m2 * women who have evidence of stage 3 or 4 of endometrial cancer
extension study of gi198745 to treat benign prostatic hyperplasia

Conditions: Benign Prostatic Hyperplasia; Prostatic Hyperplasia

Summary: the primary objective is to assess the safety of gi198745 0.05mg, 0.5mg, 2.5mg once daily for 52 weeks.

upon completion of 24 weeks of gi198745 0.05 mg, 0.5 mg, 2.5 mg, or placebo therapy in study ari20005, subjects are enrolled into an extension phase and are continued on the same therapy once daily for up to further 28 weeks, followed by up to 16 weeks of post-dosing assessments.

Eligibility criteria:
inclusion criteria: * has been receiving the investigational product for at least 20 weeks in the preceding dose finding study and the investigator or subinvestigator has confirmed the tolerability and has judged as appropriate to participate continuously in further 28 weeks treatment. exclusion criteria: * is withdrawn from the dose finding study. * has less than 75% compliance with the investigational product in the dose finding study at given the informed consent for the long-term extension study. * has a prostate cancer at giving informed consent for participating in the long-term extension study; or is suspected to have a prostate cancer in palpation, ultrasound imaging, biopsy, etc. at giving informed consent for participating in the long-term extension study. * has the post void residual volume \> 250 ml at starting the long-term extension study. (as measured by suprapubic ultrasound). * has chronic bacterial prostatitis or chronic urinary tract infections during the dose finding study * has acute urinary retention in the dose finding study. * has a history or current evidence of drug or alcohol abuse during the dose finding study * has been treated with any investigational product including post-marketing clinical trials during the dose finding study. * has myocardial infarction, coronary arterial bypass surgery, unstable angina, arrhythmia, congestive heart failure, cerebrovascular accident during the dose finding study. * has any concurrent disease or complication that, in the opinion of the investigator/sub-investigator, is difficult to evaluate efficacy of gi198745 in this study and that might poses additional risk to the patient. * is actively trying to procreate in the study period. * is unsuitable for this study, in the opinion of the investigator/sub-investigator.

Keywords: gi198745 long term extension study bph
feel4diabetes-study

Conditions: Obesity; Type 2 Diabetes

Summary: the aim of the feel4diabetes-study is to develop, implement and evaluate a community-based intervention aiming to create a more supportive social and physical environment to promote lifestyle and behaviour change to prevent type 2 diabetes among families from low and middle income countries and from vulnerable groups in high income countries in europe.

the aim of the feel4diabetes-study is to develop, implement and evaluate a community-based intervention aiming to create a more supportive social and physical environment to promote lifestyle and behaviour change to prevent type 2 diabetes among families from low and middle income countries and from vulnerable groups in high income countries in europe. the feel4diabetes-intervention will be developed according to the results of systematic literature reviews, narrative reviews and surveys regarding existing research programs, legislation and policies as well as infrastructures, facilities and human resources, which will be conducted during the first phase of the project. it will be implemented in six eurepean countries, namely belgium, bulgaria, finland, greece, hungary and spain. the process, impact, outcome, cost-effectiveness and scalability of the feel4diabetes-intervention will be evaluated and the results of the study will be disseminated via various communication channels.

Eligibility criteria:
inclusion criteria: * for children and their parents: low socioeconomic areas and/or vulnerable subgroups of population * for children: first two grades of compulsory education. exclusion criteria: * age range not within the inclusion criteria.

Keywords: prevention