Kornimate/medical-research-clean huggingface dataset:
cognitive dysfunction in chronic and persistent immune thrombocytopenia

Conditions: Immune Thrombocytopenia

Summary: individuals with immune thrombocytopenia (itp) frequently report difficulties with attention and memory. the main question this study seeks to answer is: do patients with itp have evidence of cognitive impairment as detected by a cognitive function test battery? to address this issue, participants will take a cognitive function test and complete surveys on quality of life, fatigue, depression, and cognitive symptoms. the primary aim of the study is to evaluate for the presence and extent of cognitive impairment in patients with itp. the study will also assess whether cognitive impairment in itp is associated with patient-reported impacts on quality of life, fatigue, mood, and cognitive symptoms as well as clinical characteristics such as itp disease and treatment history.

this is a longitudinal observational study that seeks to evaluate for the prevalence and extent of cognitive dysfunction in adults with persistent and chronic itp. following enrollment, subjects will complete neurocognitive testing using the nih toolbox cognition battery (nihtb-cb). in addition, subjects will complete surveys for patient-reported outcomes of quality of life, fatigue, self-reported cognitive function, and depression. background characteristics and relevant clinical history will be obtained through an enrollment survey and chart review. the primary aim of the study is to describe the prevalence and extent of cognitive impairment in itp and explore associated risk factors. this study will also assess the feasibility of longitudinal cognitive testing in patients with itp and describe any observed changes in cognition over time.

Eligibility criteria:
inclusion criteria: * adults aged ≥ 18 years * a clinical diagnosis of persistent or chronic itp, as defined by a history of platelet counts \ 12 months, respectively, and documented response to at least 1 prior itp-directed therapy. itp-directed therapies include corticosteroids, intravenous immune globulin, rho(d) immune globulin, splenectomy, thrombopoietin receptor agonists, and fostamatinib. other qualifying agents used for the treatment of itp are permissible with approval of the principal investigator. * ability to follow instructions in english. exclusion criteria: * pre-existing diagnosis of cognitive impairment from dementia, stroke, or other neurologic disease. * active psychiatric disorder, defined as uncontrolled major depression, schizophrenia, severe anxiety, or active alcohol or drug abuse. * active malignancy, requiring or likely to require chemotherapeutic or surgical treatment, except for non-melanoma skin cancer. * brain tumor or cranial surgery within the past year. * significant hearing or vision impairment that would preclude the ability to complete neurocognitive testing via a virtual platform.

Keywords: cognitive impairment immune thrombocytopenia itp quality of life cognitive dysfunction cognition
a phase ii study to assess changes in physical function in elderly patients with chronic anemia

Conditions: Anemia; Aged; Hemoglobins

Summary: the purpose of this study is to assess changes in physical function in elderly patients (\>= 65 years of age) with chronic anemia (hb \<= 11.0 g/dl) due to anemia of unknown cause and receiving weekly subcutaneous doses of epoetin alfa (procritâ®) versus placebo

some elderly patients have a chronic condition that causes anemia (reduction in hemoglobin level, or low red cell count). anemia occurs commonly with aging and is a frequent medical condition in individuals over the age of 65. physical performance and function is generally worse in individuals who are anemic. this is a randomized, double-blind, placebo-controlled, multi-center study to assess physical function (to include falls) and fatigue in approximately 80 elderly patients with chronic anemia (anemia present for at least 3 months) and who are receiving weekly procrit. the study will also evaluate hemoglobin levels (oxygen carrying protein in red blood cells), safety, fatigue and cognitive function. the study hypothesis is to demonstrate the study drug will be more effective in treatment of chronic anemia than placebo, resulting in the improvement of physical function and subsequent disabilities, generally well-tolerated. the patients will receive weekly injections of epoetin alfa (procrit®) or placebo at a starting dose of 10,000 units administered subcutaneously (under the skin).

Eligibility criteria:
inclusion criteria: * patients with a history of chronic anemia defined as a documented hb value of \<= 11.0 g/dl * no active cancer * at least 65 years of age with life expectancy of \> 6 months * community dwelling patients * patients with a short physical performance (sppb) summary score of 4-10 at screening and baseline * patients with an mini mental state examination (mmse) score \>= 24 exclusion criteria: * positive stool guaiac test * diagnosis of multiple myeloma and/or mgus * history of venous thromboembolytic disease * previous treatment with epoetin alfa, darbepoetin or any form of erythropoietin recently * uncontrolled or severe cardiovascular disease

Keywords: anemia subcutaneous injection procrit erythropoietin epoetin alfa hemoglobin level elderly
pharmacogenetics of risperidone in children with pervasive developmental disorder (pdd)

Conditions: Child Development Disorders, Pervasive

Summary: the purpose of this study is to determine if the known differences in genes influence drug metabolizing enzymes and receptors that are involved in risperidone drug action. the study will determine if differences in these genes will change the concentration of risperidone in the blood over time in children in relation to side effects and clinical response to risperidone.

to the knowledge of the investigators there are no studies documenting the pharmacokinetics and pharmacogenetics of risperidone in children with pdd. currently the ppru network is conducting a pk study whose aim is to establish a new enantio-selective micro-assay methodology and to generate preliminary population pk data of risperidone and its metabolites in pdd. this study focuses on pharmacogenetic evaluation of pdd patients having little or no effect, those that are unusually sensitive and those experiencing drug toxicity/adverse events at standard risperidone dosages. in this study two 5 ml blood samples will be drawn at a regulary scheduled pk visit. alternatively pooled waste blood samples or a buccal swab can be obtained.

Eligibility criteria:
inclusion criteria: * male and female patients between the ages of 4 and 21 years. * patients meeting dsm-iv criteria for autistic disorder, pervasive developmental disorder (pdd), or pervasive developmental disorder-not otherwise specified (pdd-nos) and about to initiate clinical treatment or currently clinically treated with risperidone. * patients about to initiate clinical treatment or currently clinically treated with risperidone, or currently on risperidone as a participant in one of the multi-site research unit for pediatric psychopharmacology (rupp) protocols. exclusion criteria: * children taking psychotropic or other medication that will significantly interact with target cyp 450 isoenzyme activity, such to the discretion of the principal investigator (pi). * patients with known renal or hepatic dysfunction (e.g. serum creatinine, and transaminases or bilirubin exceeding age specific upper range limits) are not eligible. * failure of the parent/legal guardian to give informed consent.

Keywords: risperidone autism pervasive developmental disorder (pdd)
tissue engineered constructs for alveolar cleft repair

Conditions: Cleft Lip and Palate

Summary: description of the research question in children undergoing unilateral alveolar cleft reconstruction, would stem cells carried on collagen scaffold provide bone of a good quality and quantity if compared to autogenous bone grafting? objective of the study: • research hypothesis the tissue engineered constructs will provide sufficient bone of a good quality and quantity if compared to autogenous bone graft in children undergoing unilateral alveolar cleft reconstruction. * the objectives the primary objective: assessment of bone volume (quantity) which will be provided by tissue engineered constructs compared to that provided by autogenous bone for maxillary alveolar cleft reconstruction. the secondary objective: assessment of bone density (quality) which will be provided by tissue engineered constructs compared to that provided by autogenous bone for maxillary alveolar cleft reconstruction.


Eligibility criteria:
inclusion criteria: * children with maxillary unilateral alveolar clefts requiring reconstruction * children free from any systemic disease that may affect normal healing of bone * children in an age range (8-14) year. exclusion criteria * bilateral alveolar clefts. * cleft lip or palate not including the alveolus. * immunocompromized patients. * children who undergone previous bone grafting procedure for the alveolar cleft

Keywords: tissue engineering. stem cells. autogenous grafts.
the relationship between postoperative changes of oral and intestinal flora and prognosis

Conditions: Gut Microbiota; Oral Microbiota; Colorectal Cancer

Summary: specific oral microbiome has been found to contribute to the development of colorectal cancer. we speculate that specific oral microbiota related to colorectal cancer relapse after curative treatment. this study aim to discover if any difference of oral microbiota exist in patients who suffer from cancer relapse compared with patients who do not. finally develop patient-centred programmes of surveillance protocols base on microbiota analysis.

colorectal cancer is a major cause of cancerrelated deaths and the third most commonly diagnosed cancer worldwide.current estimates indicate that 20-30% of those who undergo treatment will experience recurrence and 35% of all patients will die within 5 years. the human colon plays host to a diverse and metabolically complex community of microorganisms. while the specific oral microbiome has been found to contribute to the development of colorectal cancer. investigators speculate that specific oral microbiota related to colorectal cancer relapse after curative treatment. patients are routinely offered surveillance in order to detect disease recurrence at an early, asymptomatic stage, with the intention of improving survival. nevertheless, controversy continues to surround the optimal surveillance protocols. investigators aim to discover if any difference of oral microbiota is exist in patients who suffer from relapse compared with patients who do not. future surveillance after colorectal cancer treatment should focus on risk-stratification. finally investigators will develop patient-centred programmes of surveillance protocols base on microbiota analysis.

Eligibility criteria:
inclusion criteria: * requirements of informed consent and assent of participant, parent or legal guardian as applicable * patients who underwent exhaustive colorectal cancer surgical resection and accept colonoscopy * patients between the age of 35 and 75 years old without considering sex * patients with bmi= 18.5-23.9 * participants can follow the visit plan exclusion criteria: * patients with colorectal cancer with distant metastasis * chronic renal diseases and hepatic cirrhosis * chronic ischemic heart disease with unstable angina, chronic heart failure at class iii or iv and acute myocardial infarction in the last 6 months * individuals with a history of chronic diarrhea * individuals with a history of diabetes mellitus * individuals with a history of hypertension * individuals with a history of autoimmune diseases * use of antibiotics and probiotics 3 mouth before samples collection * individuals with a history of abdominal operation due to any reason * individuals with any history of cancer other than colorectal cancer * individuals with inflammatory bowel disease

Keywords: microbiota colorectal cancer recurrence
is it safe to do endometrial injury in the same icsi cycle: a randomized controlled trial

Conditions: Infertility

Summary: endometrial injury is one of the interventions suggested to improve the endometrial receptivity by enhancing the decidualization process, and so increasing the pregnancy rate

in assisted reproductive techniques , specially icsi, several approaches have been put forward to improve the endometrium, including endometrial injection of granulocyte colony-stimulating factor or platelet-rich plasma. endometrial injury is one of the interventions suggested to improve the endometrial receptivity. endometrial injury, also known as endometrial scratching, is the intentional damage of the endometrium, usually using a pipelle, aiming at increasing the implantation rate. the exact mechanism of action is still vague ,many hypotheses have been advocated, including enhanced decidualization, which is stimulated by the local injury. moreover, endometrial injury stimulates an inflammatory response, which in turn adjusts gene expression. the value of endometrial injury is a controversial issue, there is no agreement on the exact time to perform endometrial scratching, so in the current study, we investigated the safety and efficacy of performing endometrial injury in the follicular phase of the same icsi cycle.

Eligibility criteria:
inclusion criteria: * age \<40 year. * bmi 20-35 kg/m2. exclusion criteria: * age \>40 year * bmi \> 35 * uterine cavity abnormalities * poor quality embryos * poor responders * diagnosed sever endometriosis * sever male factor * declined to participate

Keywords: endometrial injury icsi infertility pregnancy rate
comparison of laparoscopic pectopexy and laparoscopic lateral suspension surgeries

Conditions: Patients With Pelvic Organ Prolapse; Pectopexy; Lateral Suspension; Pop-q; Pisq-12

Summary: there is not a study in the literature comparing laparoscopic pectopexy and laparoscopic lateral suspension (lls) surgeries in the surgical treatment of pelvic organ prolapse. however, there are studies comparing the efficacy of other surgery types for pelvic organ prolapse. for example,in a study, the clinical and anatomical success rate in lls operations was 83.8%, while the success rate in abdominal sacropexy operation was 89.2%.in another study in which pectopexy and vaginal sacro spinous fixation operations were compared, apical prolapse recurrence rates were found to be similar in both groups.

pelvic organ prolapse (pop) can be defined as the protrusion of the pelvic organs out of the vagina. many women experience the symptoms of prolapse of the pelvic organs during their daily activities, during sexual intercourse or during exercise. pop causes various undesirable effects in terms of sexual life and body aesthetics in women. with the increase in the number of elderly individuals in societies, the prevalence of prolapse cases is increasing and is becoming more common. patients who had laparoscopic pectopexy operation due to minimum popq stage 2 according to the international classification of pelvic organ prolapse quantification (pop q) in our hospital and who had ls lateral suspension surgery with the same indication were planned to be included retrospectively. in the first group, patients who had laparoscopic pectopexy operation were planned to be included. in the second group, it was planned to include patients who had ls lateral suspension operation. demographic and intra operative data collected before the procedure: (operation time, estimated blood loss, hospital stay, bowel and bladder injury) and intra operative and postoperative complications and recurrence rates and anatomically preoperative and post op pelvic prolapse (with pop-q classification), popq values (minimum 6 months) were aimed to be compared between two groups to assess anatomic comparement. furthermore, the patients will be called back and pelvic organ prolapse / incontinence sexual questionnaire (pi̇s-q) questionnaire will be applied to both groups and the results will be compared prospectively to assess functional results.

Eligibility criteria:
inclusion criteria: * patients with pop q stage 2 and above, operated for symptomatic pelvic organ prolapse, * being a citizen of the republic of turkey over the age of 18 * patients operated by the same experienced surgeons exclusion criteria: * to have received chemotherapy and/or radiotherapy for any reason before * having previously operated for prolapse * cases with contraindications for laparoscopy * cases with severe cardiovascular or respiratory disease
personalizing osteoporosis care: clinical & genetic risk factors for affs

Conditions: Atypical Femur Fracture

Summary: the overall objective of this project is to identify clinical and genetic risk factors for atypical femur fractures (affs) in anti-resorptive therapy (art) users by conducting a case control study of 330 cases of affs and 660 controls without affs matched for age, sex, race and duration of art.

antiresorptive therapy (art) drugs are effective osteoporosis treatment and help decrease osteoporosis-related fractures. however, their long-term use has been associated with rare but serious atypical femur fractures (affs). fear of these side effects has caused a substantial decline in the use of these effective drugs and rising fracture rates. the investigators propose to compare 330 cases of people with affs to 660 matched controls to explore similarities and differences in (1) clinical findings, such as type of art and length of use, prior fracture, bone density, femur geometry, etc., and (2) genetic variants, and then (3) to validate the top few genetic variants to see if they are indeed present in an additional group of 100 aff patients and not present in 100 control subjects. this study will determine clinical and genetic risk factors for these debilitating atypical fractures such that at-risk patients in the future can be treated differently to avoid them.

Eligibility criteria:
inclusion criteria: * cases: have experienced a confirmed, documented atypical femur fracture * controls: currently on anti-resorptive therapy, matches aff case by age, race and length of art use exclusion criteria: -
sprint interval training during rehabilitation after spinal cord injury

Conditions: Spinal Cord Injuries; Rehabilitation; Exercise

Summary: immediately following a spinal cord injury (sci), patients are admitted to inpatient rehabilitation where they undergo physical reconditioning in preparation for a return to home setting. the current standard of practice for aerobic training is performing arm-ergometry for 25 mins at a frequency of three times per week. given the move towards shortened length of stay during inpatient rehabilitation, performing mict can consume a considerable amount of therapy time. sprint interval training (sit) has been shown to elicit similar improvements in physical capacity, despite a reduced time commitment to mict. however, there are no controlled trials comparing the effects of sit to mict in individuals with sci undergoing inpatient rehabilitation. the primary aim of this study was to investigate the efficacy of a five-week, thrice weekly 10 min sit program and compare outcome measures to a traditional 25 minute mict program on the arm-ergometer in individuals with sci undergoing inpatient clinical rehabilitation. it was hypothesized that five weeks of sit and mict would induce similar changes in maximal and sub-maximal exercise performance, self-efficacy for exercise, and exercise enjoyment, despite large differences in training volume and time commitment. it was also hypothesized that sit would be well tolerated and elicit higher levels of cardiovascular strain than mict.


Eligibility criteria:
inclusion criteria: * participants with sub-acute spinal cord injury (time since injury: 14 - 182 days) * undergoing inpatient rehabilitation * aged 18-65 years * injury level at the second cervical vertebrae (c2) or below exclusion criteria: - unable to perform arm-ergometry training

Keywords: inpatient rehabilitation sprint interval training exercise spinal cord injury
antenatal steroids effect on mortality and respiratory outcomes in preterm infants

Conditions: Morbidity;Newborn

Summary: the aim is to evaluate the impact of a complete course of antenatal steroids treatment on mortality and main morbidities in a current population of preterm infants.

all infants admitted in the neonatal department born with less than 32 weeks of gestational age are included. data are prospectively recorded. perinatal variables (gestational age, materna condition at admission, antenatal steroids treatment, gender and results of histological analysis of the placenta) are recorded as well as respiratory status during hospitalization and morbidities at discharge. results of neurodevelopment test performed at 24 months of corrected age are also included.

Eligibility criteria:
inclusion criteria: * all infants admitted in the nicu (with less than 6 hours after birth) born with less than 32+0 weeks of gestational age (ga). exclusion criteria: * congenital malformations. * premature infants in whom active resuscitation measures are not established.
dose-finding study of bms-955176 to treat hiv-1 infected treatment-naive adults

Conditions: Infection, Human Immunodeficiency Virus

Summary: the purpose of this study is to find at least one dose of bms-955176 that will be safe, effective and tolerable for hiv-1 infected treatment naive adults.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com. inclusion criteria: * men and non-pregnant women, at least 18 years of age * antiretroviral treatment-naïve; defined as no current or previous exposure to \> 1 week of an antiretroviral drug * plasma hiv-1 rna ≥ 1000 copies/ml * cd4 t-cell count \> 200 cells/mm3 exclusion criteria: * resistance or partial resistance to any study drug determined by tests at screening * current or historical genotypic and/or phenotypic drug resistance testing showing certain resistance mutations to efv, tdf, ftc, protease inhibitors * chronic hepatitis b virus (hbv)/ hepatitis c virus (hcv) * blood tests that indicate normal liver function * hemoglobin \< 8.0 g/dl, platelets \< 50,000 cells/mm3
effectiveness of osteopathic manipulative therapy in nonsynostotic plagiocephaly

Conditions: Nonsynostotic Plagiocephaly

Summary: the aim of this trial is to evaluate the effectiveness of osteopathic manipulative therapy in reducing the asymmetries of skull in infants with nonsynostotic plagiocephaly.

nonsynostotic plagiocephaly (nsp) is defined as the deformation of the head resulting from external forces that mould the skull during the first months of life. four months seems to be a critical age for the development of nsp, but many positional head shape deformities may improve with time. early assessment and diagnosis is important not only for the shape of the skull, but also for possible clinical significant differences in gross motor development. in paediatric conditions the effect of osteopathic manipulative treatment is documented in systematic reviews; in nsp the only study, which is a pilot, reveals an average reduction of 50% asymmetry on 12 infants who have undergone a course of four osteopathic treatments.

Eligibility criteria:
inclusion criteria: * infants with nsp, oddi score of 104% or more. * to be at term corrected age if born prematurely. exclusion criteria: * synostotic plagiocephaly * infant who underwent an osteopathic manipulative treatment before the enrolment * dysmorphisms * syndromes * congenital muscular torcicolis * cerebral palsy

Keywords: positional plagiocephaly, deformational plagiocephaly,