Kornimate/medical-research-clean huggingface dataset:
predictive values of next generation interferon gamma release assays for latent tuberculosis infection

Conditions: Tuberculosis

Summary: this study will assess the next generation of blood tests for latent tb infection, which may be able to indicate how treatment is working as well as in diagnosis infection.

currently available blood tests for latent tuberculosis infection (ltbi) identify people who have been previously infected with m. tuberculosis. whilst they are sensitive and specific, they cannot be used to monitor the effectiveness of treatment for ltbi. new blood tests ("fourth generation quantiferon tests") give a more complete measurement of the workings of the immune system, which may be useful to show whether treatment is working. these new tests have not yet been evaluated in clinical practice, so their usefulness in identifying people at highest risk of tb disease and monitoring treatment is unknown. mass gatherings, such as the annual hajj pilgrimage, may encourage the spread of infectious diseases, including respiratory infections such as influenza, respiratory syncytial virus, and possibly also tuberculosis. however, the risk of tb infection during the hajj has not been reliably measured. it is important to measure this risk so that pilgrims can be given suitable advice about preventing infection.

Eligibility criteria:
inclusion criteria: - contacts: adult (aged 16 years or older) contacts of smearpositive pulmonary tb patients attending participating tb clinics or primary care centres for screening will be invited to take part. contacts will include all individuals with a cumulative duration of exposure of greater than eight hours to the relevant index case in a confined space during the period of infectiousness (prior to initiation of treatment). patients with active tb: newly diagnosed, microbiologically confirmed tuberculosis disease (pulmonary or extrapulmonary) attending participating tb clinics or primary care centres. hajj pilgrims: individuals arranging travel to saudi arabia for the hajj through participating tour operators. exclusion criteria: - contacts: active tb disease. individuals who are unable to give informed consent. children aged under 16 years. tb cases: individuals who are unable to give informed consent. children aged under 16 years. hajj pilgrims: active tb disease. any health indication which would prevent travel to saudi arabia. individuals who are unable to give informed consent. children aged under 16 years.

Keywords: tuberculosis diagnostic test
effect of zoledronic acid on bone metabolism in patients with bone metastasis and prostate or breast cancer

Conditions: Prostate Cancer; Breast Cancer; Bone Metastasis

Summary: bisphosphonates have been used extensively in the treatment and the prevention of skeletal complications associated with bone metastases in patients with breast cancer and prostate cancer. the purpose of this study is to assess the effect of zoledronic acid patients with prostate cancer or breast cancer and bone metastasis.


Eligibility criteria:
inclusion criteria: * prostate cancer with at least one cancer-related bone lesion with or without hormonal treatment. * breast cancer with at least one cancer-related bone lesion * negative pregnancy test at screening in case of child-bearing potential and performance status ecog 0-2 * normal liver and kidney function * prior surgery, chemotherapy and radiotherapy is allowed. at least 4 weeks must have elapsed since the completion of surgery, chemotherapy and radiotherapy to breast or bone. exclusion criteria: * prior treatment with bisphosphonates within 6 months before study start, and during treatment with zoledronic acid. known hypersensitivity to zoledronic acid or other bisphosphonates. corrected (adjusted for serum albumin) serum calcium concentration \< 8.0 mg/dl (2.00 mmol/l) or ≥12.0mg/dl (3.00 mmol/l) * current/active dental problems including * infection of the teeth or jawbone * dental or fixture trauma * current or previous osteonecrosis of the jaw * exposed bone in the mouth * slow healing after dental procedures * recent (within 6 weeks) or planned dental or jaw surgery (extraction, implants) * patients with clinically symptomatic brain metastases. severe physical or psychological concomitant diseases expected to impair compliance with the provisions of the study protocol or impair the assessment of drug of patient safety * clinically significant ascites, nyha iii or iv, cardiac failure, clinically relevant pathologic findings in ecg * history of diseases with influence on bone metabolism such as paget´s disease and primary hyperparathyroidism and with need of treatment for osteoporosis (defined according to dvo, t-score ≤2.5). * previous radiation therapy to bone (including therapeutic radioisotopes such as strontium 89) within 1 month additional protocol-defined inclusion/exclusion criteria may apply

Keywords: serum bone markers bone metastasis prostate cancer breast cancer quality of life bisphosphonates
brexpiprazole in treatment of children and adolescents with irritability associated with autism spectrum disorder for subjects that have completed participation in 331-201-00148

Conditions: Irritability Associated With Autism Spectrum Disorder

Summary: the purpose of this study is to evaluate the long-term safety and tolerability of brexpiprazole in children and adolescent participants, aged 5 to 17, with irritability associated with autism spectrum disorder.


Eligibility criteria:
inclusion criteria: * 5 to 17 year of age or turned 18 while enrolled in the 331-201-00148 study * autism spectrum disorder * completion of 331-201-00148 trial * investigator assessment exclusion criteria: * did not complete treatment period or incurred significant protocol deviations during 331-201-00148 study * sexually active males or female of childbearing potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose * female with positive pregnancy test

Keywords: autism autism spectrum disorder asd irritability
age-related macular degeneration (amd) - usability study

Conditions: Age Related Macular Degeneration

Summary: the purpose of this study is to evaluate the usability of the foresee home device with intermediate amd patients.

the amd usability study is a prospective, longitudinal, multi-center, observational study of patients diagnosed with intermediate (dry) amd who have been asked by their doctor to use the foreseehometm device to record the natural progression of their amd, including conversion from the dry to wet stage.

Eligibility criteria:
inclusion criteria * subjects diagnosed as intermediate amd in at least one eye * visual acuity (va) with habitual correction \<20/60 in the study eye * qualified in the clinic to use the device * ability to speak, read and understand instructions in english * subjects with ability to comprehend and sign the informed consent/authorization exclusion criteria * evidence of macular disease other than amd or glaucoma in the study eye * presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy * any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye

Keywords: amd
continuous epidural analgesia versus continuous supra-inguinal fascia iliaca block in total hip replacement surgery

Conditions: Postoperative Pain

Summary: comparison of continuous epidural analgesia and ultrasound guided continuous supra-inguinal fascia iliaca compartment block after total hip replacement surgery

supra-inguinal ficb is a promising safe approach for lumbar plexus that may be useful for analgesia in hip surgeries.in this study the investigators are comparing continuous s-ficb with continuous epidural analgesia after total hip arthroplasty surgeries with the primary aim to assess efficacy of post-operative analgesia, and secondary aim to assess rehabilitation indices, side effects and radiological pattern of local anaesthetic distribution after s-ficb.

Eligibility criteria:
inclusion criteria: * orthopaedic patients, american society of anesthesiologists (asa) physical status i-iii, scheduled to undergo unilateral total hip replacement surgery via lateral approach exclusion criteria: * 1- history of neurological/neuromuscular, psychiatric disease, dementia preventing proper comprehension. 2- patients younger than 18 years or older than 80 years. 3- patients with body mass index (bmi) \ 30 kg/m2. 4- coagulation disturbances (inr\>1.4, platelet count\<100 000). 5- history of opioid dependence (opioid use within the last 4 weeks). 6- history of allergies to study medications. 7- other contraindications to neuraxial blockade (e.g., patient refusal, local/systemic sepsis, low fixed cardiac output). 8- contraindications to continuous fascia iliaca compartment block (e.g., infection overlying the injection site or previous femoro-popliteal bypass surgery).
evaluation of side effects of mitotane

Conditions: Adrenocortical Carcinoma

Summary: mitotane is standard therapy in the treatment of adrenocortical carcinoma. however, many adverse effects are not well documented. therefore, we are aiming at collecting data about adverse effects in patients treated with mitotane


Eligibility criteria:
inclusion criteria: * adrenocortical carcinoma * treatment with mitotane monotherapy as first-line therapy (in adjuvant setting or advanced disease)

Keywords: adrenal cancer mitotane (lysodren) adverse events
mitochondria inborn errors of metabolism and ant defects in mitochondria diseases

Conditions: Mitochondrial Disease

Summary: the objective of this research protocol is to continue investigation of the nature and prevalence of mitochondria disease and to aid patients and health care providers in the understanding of these complex disorders. this research study brings together many clinical sub-specialists to address the etiology of these disorders and to develop more effective approaches for their diagnoses and more reliable prognoses.

the non-invasive device named diffuse optical spectroscopy developed at the beckman laser institute is to be used to measure various physiological parameters. since mitochondria produce most of the energy necessary for cellular function, their efficacy is most important for systems with a high energy demand like the brain, heart, skeletal muscle, kidney, liver, and endocrine tissues. as a result, mitochondria diseases usually manifest as complex, multi-organ disorders, requiring multispecialty investigations.

Eligibility criteria:
inclusion criteria: * male or female all ages group with diagnosis of mitochondrial disorder exclusion criteria: * subjects with visual, auditory and/or neurological problems known to result from toxic or environmental effects

Keywords: mitochondrial
ultrasound therapy and therapeutic exercise for chemotherapy induced peripheral neuropathy (cipn)

Conditions: Colon Neoplasms; Colorectal Neoplasms

Summary: the primary purpose of the trial is to determine the preliminary efficacy of therapeutic ultrasound in the treatment of pain and sensory disturbance related to chemotherapy induced peripheral neuropathy.

thirty cancer patients with colon or colorectal cancer undergoing chemotherapy treatment including the agent oxaliplatin will take part in the study. patients will be randomly assigned to either standard care alone (education and therapeutic exercises) or standard care plus 10 treatments of therapeutic ultrasound to the toes and fingers. participants in both groups will follow a home exercise program for a 6 week period. therapeutic ultrasound will be administered daily (e.g., monday to friday) over the first two week period of the study.

Eligibility criteria:
inclusion criteria: 1. adults18 or older, 2. receiving or have received chemotherapy treatment for colon or colorectal cancer, 3. chemotherapy regimen includes the agent oxaliplatin, 4. grade 1, 2 or 3 on the national cancer institute common terminology criteria for adverse events for sensory and motor neuropathy. exclusion criteria: 1. neuropathy pre-existing the patient's cancer diagnosis; 2. contraindications to therapeutic ultrasound: * active cancer in region of hands or feet, * presence of deep vein thrombosis, * lack of sensation in hands or feet, * metal or plastic implants in hands or feet; 3. peripheral vascular disease or other serious existing non-malignant disease which may affect their ability to complete testing and treatment sessions.
treatment of primary cns lymphoma ( ftd )

Conditions: Primary CNS Lymphoma (PCNSL)

Summary: the purpose of this study is to evaluate the efficacy and safety of ftd regiment (fotemustine, temozolomide and dexamethasone ) for patients with primary cns lymphoma.

primary cns lymphoma (pcnsl) is a rare b-cell variant of non-hodgkin lymphoma that is confined to the brain, leptomeninges, spinal cord, and eyes. the optimum treatment for patients with pcnsl remains challenging and at present there is no universally accepted therapeutic approach for patients with newly diagnosed disease. the purpose of this study is to evaluate the efficacy and safety of ftd regiment(fotemustine, temozolomide and dexamethasone)contrast with hd-mtx-ara-c program for patients with primary cns lymphoma.

Eligibility criteria:
inclusion criteria: age range 14-69 years old;kps performance status≥60 or ecog performance status 0-2; estimated survival time \> 3 months; histological confirmed pcnsl; none of chemotherapy contraindication;at least one measurable lesion according to recist;none of other serious diseases;patients could be followed up;none of other relative treatments including the traditional chinese medicine, immunotherapy,biotherapy except anti-bone metastasis therapy and other symptomatic treatments. volunteers who signed informed consent. exclusion criteria: currently undergoing chemotherapy, radiotherapy and targeted therapy (received chemotherapy within 3 weeks, received radiotherapy within 2 weeks, or has not recovered from any previous treatment of acute toxicity);patients with uncontrolled medical problems (including active infection, uncontrolled diabetes, severe heart, liver, kidney dysfunction and interstitial pneumonia, etc.); pregnant or lactating women;serious medical illness likely to interfere with participation;chemotherapy contraindication such as cachexia; patients with other malignancies previously;serious infection;the evidence of peripheral nervous disorder or dysphrenia; patients estimated to be unsuitable by investigato

Keywords: primary cns lymphoma chemotherapy rr pfs os
special drug use investigation for rotarix®

Conditions: Infections, Rotavirus

Summary: this study aims to determine the incidence of intussusceptions (is) (including suspected cases of intussusception) after vaccination with oral rotarix® under clinical practice, in japan.

this is non-interventional study conducted in one group received oral rotarix®.

Eligibility criteria:
inclusion criteria: * infants who receive rotarix for the first time to prevent rotavirus gastroenteritis, an indication of rotarix, will be included in the investigation. exclusion criteria: * all infants included in the drug use investigation of oral rotarix will be excluded.

Keywords: intussusceptions special drug use investigation rotavirus
the predictor study: assessing diagnostic predictors of airway collapse in patients with obstructive sleep apnea

Conditions: Sleep Apnea, Obstructive

Summary: this study is an exploratory, multicenter study of up to 300 subjects diagnosed with obstructive sleep apnea who are being evaluated for airway surgery. subjects will undergo standard evaluation for airway surgery as part of standard of care. in addition to the standard airway assessment, a simple, non-invasive measurement of the width of the inside of each subjects mouth will be performed. this measurement takes 2-3 minutes to perform.

the objective of the study is to determine whether pharyngeal width (inside of the mouth) is an appropriate measurement to predict absence of complete concentric collapse (ccc) at the soft palate

Eligibility criteria:
inclusion criteria: * patient meets the indications for the inspire upper airway stimulation * patient is being evaluated by drug-induced sleep endoscopy as standard-of-care diagnostic for osa surgery. exclusion criteria: * patient is unable to lie supine for 2-3 minutes in order to undergo airway measurement * any other reason the investigator deems that the patient is unfit for participation in the study.

Keywords: osa
functional capacity in children with chronic kidney disease

Conditions: Chronic Kidney Disease(CKD)

Summary: the aim of our study is to assess the functional capacity of children with chronic kidney disease using various tests.


Eligibility criteria:
inclusion criteria: * having been diagnosed with chronic kidney disease * being clinically stable * being between 6-18 years old * volunteering to participate in the research exclusion criteria: * having a musculoskelatal disease that may affect functional capacity measurement * having a cognitive problem
diffusion mri and growth plate injuries: pilot study

Conditions: Fracture

Summary: children who suffer fractures to the growth plates (physes) of their bones are at risk for premature growth arrest which can lead to long term complications. there is currently no technique to predict who is at risk of growth arrest following a physeal injury. the investigators aim to determine if diffusion mri (an imaging method to analyze tissue properties) can effectively pick up differences between a healthy growth plate and an injured one. this would allow orthopaedics surgeons to predict which injuries are at a higher risk of growth arrest, so earlier interventions can be done in the orthopaedic clinic.

the purpose of this study is to determine if diffusion mri can be used for tissue characterization in childhood and adolescent growth plate injuries, and to get a better understanding of the physiologic disturbance of an injured physis

Eligibility criteria:
inclusion criteria: * salter-harris type ii, iii, or iv fracture through the distal radius * growth plates are open * ages 8-12 * able to consent in english exclusion criteria: * all fractures not sustained to distal radius * sh type i or v fracture * injury to contralateral limb * previous injury to distal radius * diseases known to alter bone healing or growth\] * contraindications to undergoing an mri scan

Keywords: fracture physeal injury diffusion mri
the efficacy of autogenous dentin graft in mandibular wisdom tooth extraction

Conditions: Periodontal Pocket; Swelling Lips & Face; Trismus; Pain, Acute

Summary: the study aimed to investigate clinical effect of autogenous dentin graft on patients following mandibular wisdom tooth extraction. the primary outcomes are pain, swelling, trismus and soft tissue healing index within one week after surgery. the investigators also measured periodontal healing of distal aspect of the adjacent second molar up to 2 year after the surgery.


Eligibility criteria:
inclusion criteria: * over 18 years old * symmetry mandibular third molars * symmetry maxillary third molars with no caries or periodontal disease * mandibular second molars are available exclusion criteria: * systematic health has contraindication for surgery * pregnant or breastfeeding women * allergy with lidocaine * abnormal signs surrounding mandibular third molars
optimal dosing of high-intensity locomotor training for step attainment and locomotor outcomes in stroke patients undergoing acute inpatient rehabilitation

Conditions: Stroke

Summary: the purpose of this study is to elucidate optimal dosing for high intensity gait training (higt) to reduce locomotor disability for those undergoing inpatient rehabilitation (ir) in the subacute phase of stroke recovery. this is a randomized controlled trial conducted at a single ir facility. investigators will randomize patients to receive one of two distinct higt interventions or a high step count intervention during standard care.


Eligibility criteria:
inclusion criteria: • primary diagnosis of stroke exclusion criteria: * weightbearing restrictions, uncontrolled cardiopulmonary, metabolic, infectious, or psychiatric disorders, which would preclude aerobic locomotor training * estimated length of stay of less than 14 days * non-ambulatory status prior to admission (unable to walk \>50 meters) * pregnant
intestinal failure in necrotising enterocolitis

Conditions: Necrotizing Enterocolitis

Summary: necrotizing enterocolitis (nec) is a severe gastrointestinal disorder with high morbidity and mortality (20-40%), affecting predominantly premature neonates. nec continues to present a diagnostic challenge to clinicians. the initial clinical manifestations of nec are non-specific and indistinguishable from other gastrointestinal disorders and sepsis. the first goal of this study is to find and evaluate tests to diagnose nec at an early stage. for the development of new diagnostic markers, the investigators require knowledge of pathophysiological processes that underlie nec, which still remain unclear. therefore, the second goal of this study is to elucidate the etiology of nec. furthermore, understanding of the pathophysiology of nec can offer the possibility to develop new therapeutical treatments.


Eligibility criteria:
inclusion criteria: * neonates with abdominal signs suspected of nec * all neonates admitted to the nicu of the maastricht university medical center between july 2007 and july 2008 exclusion criteria: * no written informed consent of both parents
feasibility study of breast mri in decubitus position

Conditions: Breast Cancer

Summary: breast mri is performed in prone position which causes a number of questions. indeed, the correlation with mammography and echography and the identification of preoperative lesions can be complex as echography and surgery are carried in supine position while mammography is performed in standing position. moreover, the prone position is often considered as uncomfortable by the patients. however, there is few publications in the literature on breast mri in decubitus position.


Eligibility criteria:
inclusion criteria: * patient to benefit a mri in the assessment for a breast carcinoma or a suspicious of breast carcinoma * assessment on 3.0 tesla in magnetic resonance imaging * age \>18 years old * ecog performance status ≤ 3 * ability to provide written informed consent form exclusion criteria: * age \< 18 years old * claustrophobia * contraindication to the injection of contrast medium gadoline * contraindication to mri * persons deprived of liberty or under supervision

Keywords: imaging, three-dimensional magnetic resonance imaging/methods* breast neoplasms/diagnosis* prone position prospective studies