Kornimate/medical-research-clean huggingface dataset:
a clinical study to evaluate the efficacy, safety, and tolerability of tern-601 in adults with overweight or obesity

Conditions: Overweight or Obesity

Summary: this is a phase 2a multicenter, randomized, double-blind, placebo-controlled clinical trial studying the efficacy, safety, and tolerability of orally administered tern-601 in adults with overweight or obesity.


Eligibility criteria:
key inclusion criteria: 1. female or male aged 18 to 75 years 2. body mass index (bmi) of: 1. ≥ 30 kg/m\^2 to \< 50 kg/m\^2 or 2. ≥ 27 kg/m\^2 to \< 30 kg/m\^2 with at least 1 weight-related comorbidity 3. hba1c \< 6.5% 4. stable self-reported body weight for at least 3 months prior to study (\< 5% body weight gain or loss) key exclusion criteria: 1. have diabetes mellitus 2. have obesity induced by medication or other diagnosed endocrinologic disorders 3. have had or are planning surgical treatment or device-based therapy for obesity 4. lifetime history of suicide attempt

Keywords: overweight obesity obese glucagon-like peptide-1 receptor agonist glp-1 receptor agonist glp-1
study on booster immunization with varicella vaccine at different intervals

Conditions: VZV; Varicella Immunisation

Summary: the goal of this clinical trial is to evaluate the immunogenicity and safety of booster immunization of varicella live attenuated vaccine (varicella vaccine hereafter) at different intervals.


Eligibility criteria:
inclusion criteria: * healthy children aged 7-12 years; * has previously received a single dose of varicella vaccine, with at least 3 months since the first dose; * the subject or legal guardian can understand and sign the informed consent form (double signature is required for those over 8 years old); * participants and their legal guardians voluntarily participate in the study and are able to comply with all study procedures; * provide legal identity proof; exclusion criteria: * history of varicella; * history of severe allergic reactions to vaccines (such as acute anaphylaxis, angioedema, dyspnea, etc.); * suffering from acute disease, severe chronic disease, acute exacerbation of chronic disease; * with any confirmed or suspected immunodeficiency disease, immunocompromised or receiving immunosuppressive therapy (including systemic steroid therapy); * with a history of congenital immune diseases or close contact with family members with a history of congenital immune diseases; * with encephalopathy, uncontrolled epilepsy, other progressive neurological disorders, history of guillain-barre syndrome; * body temperature \>37℃ at the time of vaccination; * receipt of blood products within 3 months before receiving investigational vaccine; * receipt of another study drug within 30 days before receipt of the investigational vaccine; * receipt of live attenuated vaccine within 28 days before receipt of investigational vaccine; * receipt of subunit or inactivated vaccine within 7 days before receipt of investigational vaccine; * participated in other clinical trials before enrollment and were enrolled in another clinical trial during the follow-up period or planned to participate in another clinical trial within 3 months; * the participant had any other factors that were ineligible for vaccination by in the investigator's judgment.
novel diagnostics and probiotics to improve management of paediatric acute gastroenteritis

Conditions: Acute Gastroenteritis

Summary: many children admitted to hospital in botswana without bloody diarrhoea are presumed to have viral gastroenteritis and so not treated with antibiotics - but they may indeed have a treatable cause for their illness. we will conduct a randomized trial to see if rapid testing using novel methods to identify potentially treatable causes of diarrhoea leads to improved outcomes. we will also be randomizing children to probiotic therapy versus placebo (the standard of care) to see if this treatment decreases the duration of diarrhoea. the proposed study is a pilot trial, necessary before embarking on a large multi-centre trial.


Eligibility criteria:
inclusion criteria: * acute non-bloody gastroenteritis exclusion criteria: * diarrhoea \> 14 days * sepsis, pneumonia, uti, meningitis requiring empiric antibiotic therapy * malignancy, ibd * known link to another patient with diarrhoea of defined aetiology * transferred in already on antimicrobials * live outside study area * children with severe acute malnutrition will be eligible for diagnostic arm but not probiotic arm

Keywords: diarrhoea gastroenteritis rapid diagnostics probiotics sub-saharan africa
consolidative radiotherapy for colorectal cancer liver metastases receiving surgery or radiofrequency ablation

Conditions: Radiotherapy; Colorectal Cancer; Liver Metastases

Summary: this study is a randomized phase ii trial to evaluate the efficacy of adjuvant consolidative radiotherapy in colorectal cancer liver metastasis (crlm) patients after chemotherapy combined with surgical resection or radiofrequency ablation of liver lesions.

liver metastases are detected in 40-50% of patients diagnosed with colorectal cancer. local treatments like surgical resection or radiofrequency ablation result in 5-year survival of 35%. however, relapse still occurs in 70% of patients. stereotactic body radiotherapy (sbrt) has emerged as a valid treatment not only to provide excellent symptom palliation, but also is effective in local control of metastatic lesions and improves survival. the potential efficacy of sbrt as adjuvant radiotherapy in crlm patients after surgical resection or radiofrequency ablation is still unknown.

Eligibility criteria:
inclusion criteria: 1. biopsy proven unresectable metastatic colorectal cancer (crc) 2. primary resection of colorectal cancer (crc) 3. age≥18 years 4. eastern cooperative oncology group (ecog) performance status 0-1 5. absence of evidence of extra-hepatic diseases 6. 1 to 3 liver metastases with an individual maximum diameter of up to 5 cm 7. metastatic liver lesions receiving r0 or r1 resection or radiofrequency ablation with visible tumor bed 8. aspartate aminotransferase, alanine aminotransferase \& alkaline phosphates must be ≤ 2.5 times of the upper limit of normal. total bilirubin must be within the limit of normal. 9. patients should have adequate bone marrow function as defined by peripheral granulocyte count of ≥1500/mm3. 10. patients must provide verbal and written informed consent to participate in the study. 11. absence of any severe pulmonary or cardiac diseases exclusion criteria: 1. patients with either untreated brain metastases or brain metastases treated within the past three months are ineligible 2. patients who are pregnant 3. patients with severe organ dysfunction 4. history of liver radiotherapy 5. unwillingness to participate or inability to comply with the protocol for the duration of the study 6. participation in any investigational drug study within 3 months preceding the start of study treatment 7. patients not suitable to take part in clinical trials judged by researches

Keywords: radiotherapy colorectal cancer liver metastases
patient preferences, analgesic delivery method and pain reduction in spine patients

Conditions: Pain Relief

Summary: the investigators will conduct a randomized double blind study, to determine whether patient analgesic delivery mode preference affects pain reduction quality in non-surgical spine patients. the patients will receive both intra-muscular and oral non-narcotic analgesics and placebo. during the study period, pain reduction parameters will be collected. at the end of the study period, the investigators will attempt to find a correlation between pre-study patient preferences and the quality of the pain reduction achieved.


Eligibility criteria:
inclusion criteria: * patients with chronic and acute back pain exclusion criteria: * recent spine surgery

Keywords: pain intramuscular oral spine preference
in vivo measurement of the accuracy of the "neurolocate" module of the neurosurgical robot "neuromate" in its application to deep brain stimulation

Conditions: Parkinson Disease; Dystonia; Tremor

Summary: the purpose of this study is to evaluate the accuracy of the neurolocate recording system of the neurosurgical robot neuromate, marketed by renishaw, in order to optimize surgical procedures, costs and patient comfort.

robotic neurosurgery has been developed for nearly 25 years and offers neurosurgeons many advantages, including increased precision. accuracy is a key point for stereotactic neurosurgical procedures, particularly for deep brain stimulation electrode implantations. the accuracy of the neuromate robot was measured in stereotactic framed and frameless mode in vitro and in vivo during stereo-electroencephalography procedures. investigators also evaluated the actual accuracy of its application in routine deep brain stimulation procedures using a measurement system independent of the robot itself and the manufacturer. we showed that the average in vivo accuracy was 0.86 mm and the maximum error was 1.55 mm. this accuracy is at least similar to the accuracy of stereotactic frame arms and is compatible with the accuracy required in deep brain stimulation procedures. the neurolocate device is a new non-invasive, frameless patient matching module designed for use with the neuromate stereotactic robot. the main advantages of the neurolocate system are that it is less invasive than screw-on markers, simplifies the surgical procedure and reduces the duration of the surgery the accuracy of the neurolocate frameless recording system was evaluated in vitro and in vivo for robotic stereo-electroencephalography trajectories in epileptic patients and compared to the accuracy of conventional recording using a stereotactic frame. however, the accuracy of the neurolocate recording system has never been measured in vivo during deep brain stimulation procedures.

Eligibility criteria:
inclusion criteria: * patients aged 18 to 70 years old requiring a stereotactic robot-guided deep brain stimulation procedure * signature of the informed consent form * affiliation to the french social security system exclusion criteria: * contraindication to mri * hypersensitivity to gadoteric acid, meglumine or any product containing gadolinium. * anterior and posterior commissure anatomy modifying brain anatomy * patient unable to complete the comfort questionnaire due to cognitive or speech impairment * pregnant or breastfeeding women
repeated low-level red-light therapy shortens axial length

Conditions: High Myopia; Axial Length; Eye Diseases

Summary: the purpose of this clinical trial is to investigate the incidence and magnitude of axial length shortening after repeated low-level red-light therapy in high myopia children and teenagers.

high myopia has become a major public concern globally, which is characterized by excessive axial elongation of the eyeball. axial elongation is accompanied by mechanical stretching and thinning of the choroid and sclera, causing vision-threatening complications. repeated low-level red-light (rlrl) therapy is an emerging effective and safe therapy for myopia control. previous clinical trials in china have observed clinically significant axial shortening after rlrl treatment. the purpose of this study is to investigate and identify possible mechanism for axial length (al) shortening after 12-month rlrl therapy in highly myopic children and teenagers aged 8-18 years. in addition to single vision spectacles, subjects will receive rlrl treatment at home under supervision of the parents/guardians according to a standard protocol. axial length, visual acuity, cycloplegic spherical equivalent refraction, slit lamp, fundus camera and optical coherence tomography/angiography will be measured at 1-, 3-, 6- and 12-month follow-up visits.

Eligibility criteria:
inclusion criteria: 1. provision of consent. 2. age: ≥ 8 and ≤ 18 years at enrolment. 3. high myopia: cycloplegic sphere of -6.00 diopters (d) or greater in both eyes. 4. willing and able to participate in all required activities of the study. 5. the children currently on myopia control treatment can be recruited if myopia control treatments (including but not limited to atropine, orthokeratology, rigid gas-permeable lenses, defocus spectacles, etc.) are discontinued for at least 2 weeks. 6. normal fundus, tessellated fundus or with peripapillary diffuse chorioretinal atrophy. exclusion criteria: 1. secondary myopia, such as a history of retinopathy of prematurity or neonatal problems, or syndromic myopia with a known genetic disease or connective tissue disorders, such as stickler or marfan syndrome. 2. pathologic myopia with signs of macula-involving diffuse chorioretinal atrophy, patchy chorioretinal atrophy, macular atrophy, lacquer cracks, myopic choroidal neovascularization or fuchs' spots. 3. strabismus and binocular vision abnormalities in either eye. 4. previous any intraocular surgery affecting refractive status. 5. other reasons, including but not limited to ocular or other systemic abnormalities, that the physician may consider inappropriate for enrolment.
a novel classification of sagittal spinal alignment to aid surgical planning for adult spinal deformity

Conditions: Adult Spinal Deformity; Sagittal Deformity; Sagittal Alignment; Sagittal Imbalance

Summary: surgical outcomes, including radiographic outcomes, patient-reported outcomes, postoperative complications, and revision surgery rates, were compared in patients with adult spinal deformity who underwent correction surgery with reference to our pelvic incidence-dependent (pi-dependent) clustering of sagittal spinal alignment and existing standards (sagittal age-adjusted score \[saas\], global alignment and proportion \[gap\] score, and roussouly classification). our findings may provide tangible guidance for surgical decision-making in asd.


Eligibility criteria:
inclusion criteria: 1. ≥ 18 years of age at the time of treatment; 2. complete radiographic data, including standing posteroanterior and lateral whole-spine radiographs, lumbar computed tomography, and lumbar magnetic resonance imaging; 3. radiographic evidence of asd: sagittal vertical axis ≥ 50 mm, pelvic tilt ≥ 25°, pelvic incidence-lumbar lordosis mismatch ≥ 10°, and/or thoracic kyphosis ≥ 60°. exclusion criteria: 1. any type of previous spinal surgery; 2. other musculoskeletal problems impeding walking ability, syndromic or neuromuscular diseases such as parkinson\&#39;s disease, inflammatory conditions such as ankylosing spondylitis, infectious conditions such as spinal tuberculosis, metabolic diseases such as severe osteoporosis, and/or serious general medical conditions such as sepsis or malignancy; 3. pathology of deformity as follows: post-traumatic deformity, adult idiopathic scoliosis of the thoracic spine, or de-novo lumbar scoliosis; 4. hip joint kellgren-lawrence grade ≥ ii, history of hip joint and/or knee joint pain, and/or previous joint replacement.
the efficacy of traditional chinese herbal medicine for dementia

Conditions: Dementia; Alzheimer Disease

Summary: the clinical trial is a pilot study for treatment of alzheimer dementia by traditional chinese herbal medicine(tcm).

dementia is a chronic, progressive neurodegenerative syndrome, characterized by an abroad category of non-reversible impairment in cerebral function, making a long-term and gradually decrease in the ability to mental cognitive tasks and performance of daily activities. the world health organization says that 47.5 million people around the world are living with dementia. alzheimer's disease is the most common type of dementia. alzheimer's disease is often getting worse with time, affecting memory, language, and thought. according to the record from ministry of health and welfare in taiwan. the population over 65 year-old is more than 3.36 million. it is estimated that there are more than 250,000 people with mental disabilities, and nearly 600,000 people with mild cognitive impairment (mci). alzheimer's disease is accounting for 60-70%, the most common type of dementia. with the aging of population, experts predict that the number of patients suffering from alzheimer's disease will be up to 800,000. in 2016, a study based on the health insurance database in taiwan showed that 78.2% of patients will take chinese medical treatment, such as herbal medicine, acupuncture or traumatology medical therapy like massage after diagnosed as alzheimer's disease during 1997-2008. the clinical trial is a pilot study. the main purpose of this study is to evaluate the efficacy of traditional chinese herbal medicine(tcm) of alzheimer's dementia. the participants diagnosed as alzheimer's dementia will be given traditional chinese herbal medicine powder, each pack included of jia wei xiao yao san granule(5 gm), gou teng granule (1.1 gm),and ba ji tian (1.1 gm), 2 times per day for 12 weeks. the participants will be assessed by the mmse, iadl, npi-q, gds, qol-ad, ccmq, which will be conducted at baseline, 0weeks, 12weeks, and follow-up (16 weeks). to see if the traditional chinese herbal medicine can improve the symptoms of alzheimer's dementia or its related symptoms.

Eligibility criteria:
inclusion criteria: 1. diagnosis of mild to moderate alzheimer dementia; 2. aged over 65 years old in both gender; 3. mmse score between 14 and 26; 4. adequate vision and hearing ability to complete all study tests; 5. with a stable caregiver. exclusion criteria: 1. a medical history of other dementia types, like frontotemporal dementia, dementia with lewy bodies, vascular dementia, and mixed type, et al; 2. known of other neurological diseases, cranial nervous system cancer 3. severe liver or kidney dysfunction (alanine aminotransferase\>200 iu/l, aspartate transaminase\>200 iu/l or serum creatinine \>2.5 mg/dl); 4. severe cardiovascular disease (heart failure, coronary heart disease)

Keywords: chinese herbal medicine herbal treatment
comprehensive dna methylation profiling in crohn's disease

Conditions: Crohn Disease; Methylation; Illumina Human Methylation 850k BeadChip

Summary: previous studies have indicated that abnormal dna methylation frequently occurs in the mucosa in crohn's disease. comprehensive dna methylation profiling of the inflamed and non-inflamed ileal mucosa of patients with crohn's disease was performed. genome-wide dna methylation was determined using the illumina humanmethylation 850k beadchip.


Eligibility criteria:
inclusion criteria: * active crohn's disease(cdai score≥ 150) exclusion criteria: * no ileal lesions * under treatment of immunomodulators, biologic agents or steroids
doravirine concentrations and antiviral activity in cerebrospinal fluid in hiv-1 infected individuals

Conditions: HIV-1-infection

Summary: doravirine is a new hiv-1 non-nucleoside reverse transcriptase inhibitor (nnrti) that has demonstrated a good efficacy and safety profile in clinical trials. it functions by inhibiting viral replication of both wild-type virus and most common nnrti variants. it is dosed orally once daily and always given in combination with other hiv-1 active agents as part of highly active antiretroviral therapy. initial pharmacokinetic studies demonstrated not extensive binding to plasma proteins, which may be crucial determinant for penetration to different reservoirs such as the central nervous system (cns). this study will address two important issues: the pharmacokinetic profile of doravirine in cerebrospinal fluid (csf) as well as the maintenance of hiv suppression in csf. the assessment of concentrations as well as the antiviral activity of new antiretroviral drugs in compartments such as cns is relevant to avoid hiv-related neurocognitive disorders as well as for future cure strategies. in addition, the role of unbound arv drug concentrations has been scarcely evaluated.

15 asymptomatic, virologically suppressed, hiv infected patients will be offered to switch their antiretroviral treatment to doravirine+emtricitabine/taf. after 4 weeks of treatment all subjects will undergo lumbar puncture and bloods in order to assess csf and plasma (total and unbound) doravirine concentrations. hiv rna also will be assessed. all subjects will complete a follow up visit 4 weeks after

Eligibility criteria:
inclusion criteria: 1. asymptomatic, hiv-1 infected individuals ≥ 18 years of age 2. be on a stable art continously or ≥3 consecutive months preceding the screening visit. patients already receiving taf/ftc+doravirinec for at least three consecutive months will be eligible. 3. plasma hiv-1 rna at screening \<40 copies/ml for at least 3 months at the screening visit. 4. signed and dated written informed consent prior to inclusion. 5. subjects must agree to utilize a highly effective method of contraception during heterosexual intercourse from the screening visit throughout the duration of the study. exclusion criteria: 1. severe hepatic impairment (child-pugh class c) 2. ongoing malignancy 3. active opportunistic infection 4. primary resistance to any of the arv included in the study or history of virologic failure with risk of resistance selection to any of the study drugs. 5. any verified grade 4 laboratory abnormality 6. alt or ast ≥ 3xuln and/or bilirubin ≥ 1.5xuln 7. adequate renal function: estimated glomerular filtration rate ≥ 50 ml/min 8. females who are pregnant (as confirmed by positive serum pregnancy test) or breastfeeding. 9. current treatment with antiaggregant or anticoagulant therapy. 10. history of any neurologic disease/condition/treatment may alter the blood brain barrier permeability.

Keywords: doravirine
comparing two medical treatments for early pregnancy failure.

Conditions: Early Pregnancy Failure

Summary: this study aims to compare whether a combination of two drugs (mifepristone and misoprostol) are superior compared to using only one of these drugs (misoprostol) as medical treatment for a miscarriage. women in whom early pregnancy failure, 6-14 weeks postmenstrual, is ultrasonographically confirmed qualify for this study. it is expected that the combination of mifepristone and misoprostol is more effective in reaching complete evacuation, and therefore can prevent more invasive treatment such as curettage.

this study will test the hypothesis that, in early pregnancy failure, the sequential combination of mifepristone with misoprostol is superior to the use of misoprostol alone in terms of complete evacuation of products of conception (primary outcome), patient satisfaction, complications, side effects and costs (secondary outcomes). the trial will be performed multi-centred (hospitals), prospectively, two-armed, randomized, double-blinded and placebo-controlled. women with ultrasonographically confirmed early pregnancy failure (6-14 weeks postmenstrual), managed expectantly for at least one week, can be included. before medical treatment with misoprostol (two doses 400mcg (four hours apart), repeated after 24 hours if no tissue is lost), patients will be randomized to oral mifepristone (600mg) or oral placebo (identical in appearance). the investigators aim to randomize 460 women in a 1:1 ratio, stratified by centre. after six weeks, the primary endpoint, complete or incomplete evacuation, will be determined

Eligibility criteria:
inclusion criteria: early pregnancy failure, 6-14 weeks postmenstrual with * a crown-rump length ≥ 6mm and no cardiac activity or * a crown-rump length \<6mm and no fetal growth at least one week later or * a gestational sac with absent embryonic pole for at least one week. * at least one week after diagnosis or a discrepancy of at least one week between crown-rump length and calendar gestational age * intra-uterine pregnancy * women aged above 16 years * hemodynamic stable patient * no signs of infection * no signs of incomplete abortion * no contraindications for mifepristone or misoprostol exclusion criteria: * patient does not meet inclusion criteria, discovered after randomization * inability to give informed consent * known clotting disorder or use of anticoagulants * known risk factors for, or presence of, a cardiovascular disease * language barrier

Keywords: miscarriage mifepristone misoprostol medical treatment patient satisfaction abortifacient agents