Kornimate/medical-research-clean huggingface dataset:
avantage® reload double mobility acetabular cup -clinical study

Conditions: Primary Osteoarthritis; Post-Traumatic Arthritis; Inflammatory Joint Disease; Femoral Neck Fracture; Femoral Head Necrosis; Sequelae From Previous Hip Surgery; Osteotomies; Congenital Hip Dysplasia

Summary: this is a post marketing clinical follow up study (pmcf) on the avantage reload dual mobility system cup.

the study objective is to document the patients' survivorship at 10 years and evaluate the performances at 3 months, 1, 2, 3, 5, 7 and 10 years post-surgery of the avantage reload cup. secondary objective is to evaluate the polyethylene wear between e1 and arcom. 500 patients was the enrollment goal with 2 subgroups. * subgroup 1: prospective and non-controlled to satisfy odep (orthopedic device evaluation panel) requirements; * subgroup 2: randomized and controlled to compare the polyethylene wear between the arcom and the e1 liners.

Eligibility criteria:
inclusion criteria: * selection of subjects for this evaluation should be in accordance with the indications of the avantage® reload with e1™ or arcom™ liner specifically * primary osteoarthritis * post-traumatic arthritis * inflammatory joint disease (e.g. rheumatoid arthritis) * femoral neck fracture * femoral head necrosis * sequelae from previous hip surgery, osteotomies, etc. * congenital hip dysplasia additional inclusion criteria include: * male or female * 18 years of age or older * subjects willing to return for follow-up evaluations * subjects who read, understand study information and give written consent (specific local regulatory requirements) exclusion criteria: * exclusion criteria should be in accordance with contraindications for the avantage® reload: absolute contraindications include: * infection * sepsis * severe muscular, neurological or vascular deficiencies of the extremity involved * bone destruction or poor bone quality additional contraindications include: * subjects unable to co-operate with and complete the study * dementia and inability to understand and follow instructions * neurological conditions affecting movement * patient over 18 under law supervision

Keywords: total hip arthroplasty hip implant
study of ivacaftor in cystic fibrosis subjects 2 through 5 years of age with a cftr gating mutation

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to evaluate the safety, pharmacokinetics (pk), and pharmacodynamics (pd), of ivacaftor in children with cystic fibrosis (cf) who are 2 through 5 years of age and have a cf transmembrane conductance regulator (cftr) gating mutation in at least 1 allele. part a is designed to evaluate the safety and pk of multiple-dose administration of ivacaftor in participants 2 through 5 years of age and to confirm the doses for part b. part b is designed to evaluate the safety, pk, pd, and efficacy of ivacaftor in participants 2 through 5 years of age.


Eligibility criteria:
inclusion criteria: * male or female with confirmed diagnosis of cf * must have a cftr gating mutation in at least 1 allele * aged 2 through 5 years at screening and day 1 * weight \>= 8 kg at screening and day 1 * hematology, serum chemistry, coagulation, and vital signs results at screening with no clinically significant abnormalities that would interfere with the study assessments, as judged by the investigator exclusion criteria: * history of any illness or condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant * an acute upper or lower respiratory infection, or pulmonary exacerbation, or changes in therapy for pulmonary disease within 4 weeks before day 1 * abnormal liver function, at screening * history of solid organ or hematological transplantation * use of any moderate or strong inducers or inhibitors of cytochrome p450 (cyp) 3a within 2 weeks before day 1 * participation in a clinical study involving administration of either an investigational or a marketed drug within 30 days or 5 terminal half-lives before screening

Keywords: cystic fibrosis
interaction between patient and healthcare provider: response to acupuncture in knee osteoarthritis

Conditions: Osteoarthritis

Summary: interactions between patients and healthcare providers may have a significant impact on a patient's response to therapy. in this study, patients with osteoarthritis (oa) of the knee will receive either acupuncture or sham acupuncture. the acupuncturists will be trained to interact with the patients in specific ways. the study will evaluate those interactions.

this study will examine placebo responses in the context of practitioner-patient interactions at the time of the encounter. phase 1 of this study identified patient-related determinants of placebo response, such as beliefs and expectations toward treatment of knee oa with acupuncture. phase 2 of the study evaluated an assessment tool to measure these determinants. phase 3 of the study is a randomized controlled trial to evaluate whether placebo effects in patients with knee oa can be enhanced by the acupuncturists' communicative style, which can affect a patient's cognitive expectancies and beliefs. patients will initially be randomized to one of two groups, each with a different model for practitioner-patient interaction. acupuncture practitioners will be trained to follow semi-structured communicative styles, including traditional approaches in chinese medicine and techniques previously described in patient-doctor communications studies. within each of these groups, patients will be further randomized to receive either acupuncture or sham acupuncture. patients will have 6 weeks of biweekly treatment visits. patients will be followed for 6 months. visits will be weekly during the first 6 weeks of the study and monthly thereafter. the study will also include a natural cohort group composed of patients on a study waiting list; these patients will be offered acupuncture 3 months after study entry.

Eligibility criteria:
inclusion criteria: * oa diagnosis according to the american college of rheumatology criteria * pain in the knee of at least 3 or more on a 0 to 10 scale (0 none, 10 extreme pain) within 2 weeks prior to study entry * stable treatment with anti-inflammatory and analgesic medications during the month prior to study entry * if receiving glucosamine, stable dosage for 2 months prior to study entry * adequate cognitive status as determined by the study officials * living in the community * ability to communicate in english without a translator * access to a telephone exclusion criteria: * other diagnosed joint diseases, such as rheumatoid arthritis * previous treatment with acupuncture (for any condition) * intra-articular injections in the knee in the 2 months prior to study entry

Keywords: acupuncture arthritis
neurocognitive outcomes after whole brain radiation therapy for hematologic malignancies

Conditions: Central Nervous System Lymphoma; Hematopoietic and Lymphoid Cell Neoplasm; Leukemia; Lymphoma; Plasma Cell Myeloma; Secondary Central Nervous System Lymphoma

Summary: this study assesses neurocognitive outcomes after receiving radiation therapy to the brain (whole brain radiation therapy) in patients with blood cancers (hematologic malignancies). this may help researchers learn more about the effects of whole brain radiation therapy on memory and thinking in patients with blood cancer.

primary objective: i. record patients' cognitive outcomes after whole-brain radiation therapy (wbrt) for hematologic malignancies using standard-of-care neurocognitive function testing. secondary objectives: i. assess patients' quality-of-life after wbrt for hematologic malignancies, based on a validated questionnaire. ii. explore magnetic resonance imaging (mri) changes in the brain after wbrt for hematologic malignancies, based on standard-of-care imaging studies. iii. study the role of memantine in patients' cognitive outcomes during and after wbrt for hematologic malignancies, based on standard-of-care use, utilizing standard-of-care neurocognitive function testing. outline: patients undergo neurocognitive function assessments, complete questionnaires over 8-10 minutes and undergo standard of care mri at baseline (within 4 weeks before the first day of wbrt), 2, 6, 12 months after rt completion, then annually for 5 years.

Eligibility criteria:
inclusion criteria: * age 18 years or older * treatment with radiation therapy to the brain for a hematologic malignancy (ex. primary central nervous system lymphoma \[pcnsl\], secondary central nervous system lymphoma \[scnsl\], leukemia, myeloma) * proficient and capable of completing tests in english * patients with claustrophobia are eligible if the claustrophobia is managed with medication * patients with cognitively-impairment are eligible if the impairment is managed with medication * patients who are pregnant
aerobic versus resistive training on functional capacity in acute myeloid leukemia

Conditions: Acute Myeloid Leukemia in Remission

Summary: sixty patients with aml from both sexes aged from 35-45 years were selected from hematology department in nasser institute hospital where the study was conducted. patients were randomly assigned into two groups equal in number. group (a) underwent aerobic exercises in the form of cycling with 50-60% of maximum heart rate. group (b) underwent resistive training conducted in the form of a series of exercises using free weights, and dumbles. sessions were conducted three times /week for eight weeks. six minutes' walk test (6mwt), 10 repetitions maximum test (10 rm), ventilatory function test, fatigue and quality of life (qol) scales were used to assess functional capacity in both groups.

aerobic ex group: included 30 patients who underwent aerobic training with 50 %-60% of maximum heart rate in the form of cycling by bicycle ergometer for eight weeks, three sessions/week. resistive ex group: included 30 patients who underwent a resistive training which were conducted in the form of a series of exercises using free weights, and dumbles to increase the strength of arms, pectoral muscles, abdominal, back muscles and gluteal region. patients carried out three sets of 20-30 dynamic repetitions or static isometric exercises for 40-60 seconds for each muscle group and rested 1-2 min between series. sessions were conducted three sessions/week for eight weeks.

Eligibility criteria:
inclusion criteria: * acute myeloid leukemia survivors from both sexes * their age ranged from 35-45 years. * patients were in remission stage contains less than 5% blast cells in their bone marrow, absolute neutrophil count (\>1000/microl), platelet count(\>100,000/microl),and independence from red cell transfusion. exclusion criteria: * extramedullary leukemia * musculoskeletal deformities * severe anemia (hemoglobin less than 8g/dl). * autoimmune thrombocytopenia (platelets less than 10000ul or leucocytes count more than 3000ul).
an international chart review and survey for the prevalence and clinical management of atherosclerotic cardiovascular diseases in patients with type 2 diabetes across countries in the middle east and africa

Conditions: Diabetes Mellitus, Type 2

Summary: the study is intended to estimate the proportion and clinical management of people with type 2 diabetes having atherosclerotic cardiovascular diseases or who are at high risk to develop atherosclerotic cardiovascular diseases. participants will be asked to give information about their health. partipants will continue normal way of life and will not get any medication other than those prescribed to them by the doctor. the study will last for about 6 months.


Eligibility criteria:
inclusion criteria: 1. signed informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol). 2. male or female, age greater than or equal to 18 years at the time of signing informed consent. 3. diagnosed with t2d grater than or equal to 180 days prior to the day of signing informed consent exclusion criteria: 1. previous participation in this study. participation is defined as having given informed consent in this study. 2. mental incapacity, unwillingness, inability, or language barriers precluding adequate understanding or cooperation 3. diagnosed with type 1 diabetes (t1d). 4. patients with known congenital heart disease/malformation
transcranial magnetic stimulation in mild cognitive impairment and alzheimer disease

Conditions: Alzheimer Disease; Mild Cognitive Impairment

Summary: the investigators reviewed 12 years of clinical use in an outpatient neurology setting of transcranial magnetic stimulation (tms) in patients with alzheimer's disease (ad) and mild cognitive impairment (mci) to evaluate safety and efficacy of tms.

the investigators compiled demographic, clinical, and neurocognitive data on all patients who had received tms for any reason in the clinic over a 12-year period. of 236 patients receiving tms, 59 patients with ad and 14 with mci satisfied study criteria and were compared to controls from the national alzheimer's coordinating center (nacc). neurocognitive outcomes were compared between magnetic resonance imaging (mri) and electroencephalogram (eeg)-grid guided tms in patients. tolerability data was reviewed for all patients.

Eligibility criteria:
inclusion criteria: * patients meeting the national institute of neurological and communicative disorders and stroke and alzheimer's disease and related disorders association (nincds- adrda) criteria for possible or probable alzheimer's disease. * patients meeting the national institute of neurological and communicative disorders and stroke and alzheimer's disease and related disorders association (nincds- adrda) criteria for mild cognitive impairment. * patients must have undergone at least two standardized neurocognitive batteries before and after beginning tms. * patients must have received greater than or equal to five (5) tms sessions in less than one year. exclusion criteria: • patients with dementias from other causes, such as lewy body disease.

Keywords: tms transcranial magnetic stimulation
efficacy of eye movement desensitization and reprocessing (emdr) therapy versus selective serotonin reuptake inhibitors (ssris) in the treatment of post-traumatic stress disorder

Conditions: PTSD; PTSD - Post Traumatic Stress Disorder

Summary: this randomized controlled trial aims to compare the efficacy of eye movement desensitization and reprocessing (emdr) therapy versus selective serotonin reuptake inhibitors (ssris) in the treatment of post-traumatic stress disorder (ptsd). adult patients diagnosed with ptsd will be randomly assigned to receive either emdr therapy or ssris for a period of six weeks. the primary outcome is the rate of remission as measured by validated ptsd symptom severity scales at week 6. secondary outcomes include changes in functional impairment and patient-reported quality of life. the study seeks to determine whether emdr therapy is a non-pharmacological alternative to ssris for achieving symptom remission in ptsd.


Eligibility criteria:
inclusion criteria: age 18-60 years clinical diagnosis of post-traumatic stress disorder (ptsd) duration of illness ≥ 6 months able to provide informed consent exclusion criteria: current substance abuse or dependence history of psychotic disorder or bipolar disorder active suicidal ideation concurrent psychotherapy or psychiatric medication (except study-assigned ssri)

Keywords: ptsd emdr ssris trauma mental health randomized controlled trial post-traumatic stress disorder eye movement desensitization and reprocessing
efficacy and feasibility of combining folfirinox and stereotactic radiotherapy for patients with irresectable locally advanced pancreatic cancer.

Conditions: Pancreatic Neoplasms

Summary: the purpose of this study is to investigate whether combining folfirinox chemotherapy and stereotactic radiotherapy in patients with locally advanced pancreatic cancer leads to an increase in survival.


Eligibility criteria:
inclusion criteria: * cytological or histologically confirmation of pancreatic cancer. * who performance status of 0 or 1 * asa classification i or ii * tumor considered locally advanced after diagnostic work-up including ct-imaging and diagnostic laparoscopy. * no evidence of metastatic disease * largest tumor diameter \< 7 cm x 7 cm x 7 cm * normal renal function (creatinine ≥ 30 ml/min). * normal liver tests (bilirubin \< 1.5 times normal; alat/asat \< 5 times normal) * normal bone marrow function (wbc \> 3.0 x 10e9/l, platelets \> 100 x 10e9/l and hemoglobin \> 5.6 mmol/l) * age \> 18 years and \< 75 years * written informed consent exclusion criteria: * prior radiotherapy, chemotherapy or resection (bypass surgery allowed). * lymph node metastases from primary tumor outside the field of radiation. * second primary malignancy except in situ carcinoma of the cervix, adequately treated non-melanoma skin cancer, or other malignancy treated at least 3 years previously without evidence of recurrence. * pregnancy, breast feeding. * serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.

Keywords: locally advanced pancreatic cancer chemotherapy stereotactic radiotherapy
erector spinae plane block vs transforaminal epidural injection

Conditions: Discogenic Low Back Pain

Summary: lumbar disc herniation is the main cause of low back pain and radicular leg pain. steroids administered to the epidural area reduce the inflammatory response and pain by inhibiting the synthesis of proinflammatory agents. epidural steroid injections are used in the treatment of lumbosacral radicular pain with various techniques including fluoroscopy-guided transforaminal and interlaminar injection. ultrasound-guided erector spina plan block (espb) was first described in 2016 and has been used for postoperative analgesia in many surgeries including thoracic and lumbar dermatomes. the distribution of local anesthesia in the espb from the paravertebral area to the transforaminal and epidural space has been shown in studies. the aim of this study was to compare the efficacy of ultrasound-guided espb and fluoroscopic guided transforaminal epidural steroid injection in chronic discogenic low back pain.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologist's physiologic state i-iii patients * patients with unilateral radicular pain and low back pain persisting despite medical treatment. exclusion criteria: * spinal cord disease or spinal mechanical instability, * previous low back surgery, * more than two levels of lumbar disc hernia, * allergic to local anesthetic drugs to be used, * use of oral anticoagulants, * uncontrolled diabetes mellitus type i and ii
long pressure autoregulation index

Conditions: Traumatic Brain Injury

Summary: the pressure reactivity index (prx) has emerged as a surrogate method for the continuous bedside estimation of global cerebral autoregulation and a significant predictor of unfavorable outcomes. however, calculations require continuous, high-resolution monitoring and are currently limited to specialized icus with dedicated software. to overcome this problem, new indices calculated using one-minute average data, instead of 10-second average data as performed by the prx, have been proposed. the study aims to test new physiological indices appropriately modified to adapt to the scarcity of output data generated by standard hospital systems (frequency \~0.0033 hz, approximately a 5-minute period) and to evaluate their association with outcome measures.

data preparation and index calculations were performed using an in-house algorithm. data extracted and processed with the algorithm: ultra-low pressure reactivity index (ul-prx), intracranial pressure (icp), cerebral perfusion pressure (cpp), arterial blood pressure (abp), heart rate (hr), respiratory rate (rr), temperature, end-tidal co2 (etco2), saturation (spo2).

Eligibility criteria:
inclusion criteria: * patients with a clinical diagnosis of acute neurological injury requiring intracranial pressure (icp) monitoring. * availability of continuous intensive care monitoring of physiological data. exclusion criteria: patients with less than 8 hours of physiological data monitoring.
is a pre-contrast scan necesary to diagnose acute aortic syndrome?

Conditions: Acute Aortic Syndrome

Summary: acute aortic syndrome (aas) is a potentially life-threatening cause of sudden, severe chest pain. there are several possible underlying causes, which cannot be distinguished from one another at the bedside. current practice is to image this with two ct scans of the chest, one before injection of a contrast dye into the blood stream and then one after. with the advancement of ct scanner technology, improvements in software interpretation and screen resolution, the investigators hypothesise that performing the contrast scan on its own is diagnostically equivalent to both the pre- and contrast scans

aas include: a tear in the wall of the main artery from the heart, bleeding directly into this wall, an ulcer in the wall, and excess dilatation and rupture of the main artery wall. these are also treated differently according to where they are in the length of the aorta. it is therefore important to identify precisely the subtype of aas and its location to allow the clinician to manage the patient appropriately. current practice is to image this with two ct scans of the chest, one before injection of a contrast dye into the blood stream and then one after. the one before the contrast is used to determine if there is bleeding within the wall, which would show up as white on this scan. it is currently accepted that the contrast in the artery itself would hide the presence of bleeding within the wall. the other causes are seen primarily on the contrast scan only. every patient proceeds from the pre-contrast scan to the contrast scan, unless there is a contraindication to the intravenous dye. the investigators own database search has shown that radiologists protocol the scans according to their own preference and experience (i.e. some do both scans, others the contrast scan only). there is conflicting advice from international professional bodies as to whether to perform the non-contrast scan every time. some studies have shown that although the pre-contrast scan is sensitive to picking up bleeding within the wall, it adds nothing more over an increased radiation dose to the patient. the investigators hypothesise that performing the contrast scan on its own is diagnostically equivalent to both the pre- and contrast scans to look for all 4 of these entities that make up aas. the investigators also propose that not requiring the pre-contrast scan would have significant savings in patient radiation dose, scanner time, network resources and radiologist time.

Eligibility criteria:
inclusion criteria: * male and female adult (age\>18) patients presenting with symptoms of aas who had thoracic aortogram cts. exclusion criteria: * age\<18