Kornimate/medical-research-clean huggingface dataset:
dasatinib down-regulates the expression of pd-1 and enhances killing ph + leukemia stem cells

Conditions: Chronic Myeloid Leukemia

Summary: research on the mechanism of dasatinib down-regulates the expression of pd-1 in cmv-activated nkg2c+nk cells and enhances killing ph + leukemia stem cells.

some patients with cml can withdraw from tkis after treatment, and the mechanism might be related to the effect of memory nk cells on anti-ph+ leukemic stem cells (lscs). dasatinib affects immune through several pathways including the expression of pd1 in immune cells. our previous work showed increased nkg2c+ nk cells were found in cases with cmv-dna+ who suffered ph+ leukemia and received dasatinib, and these memory nk cells have anti-lscs activity. we hypothesize that: cmv infection activates nkg2c+ memory nk cells proliferation; dasatinib down-regulates the expression of pd1 in pd1+nkg2c+ nk cell subsets and then enhances anti-lscs activity of these cells. in this study, the effect of dasatinib on cmv-activated nkg2c+ cell subsets and its mechanism will be studies. besides, the different nkg2c+ cell subsets on lscs will be compared. this study might be helpful to clarify the mechanism of tki withdrawal and to offer foundation for cmv and ph+ all treatment strategies

Eligibility criteria:
inclusion criteria: 1. age \>18 years old, gender is not limited 2. cml-cp patients treated with tkis 3. no pregnancy was planned during the treatment exclusion criteria: 1.the researcher judged that it was not suitable to participate in this study
a rollover study for subjects who completed participation in the vrx496-usa-05-002 trial

Conditions: HIV Infections

Summary: the objective of this study is to determine the long term safety and tolerability of an additional infusion of 10 billion vrx496 gene-modified cd4 t cells with a focus on evaluating additional therapeutic benefits with respect to viral load and cd4 counts.

the study has concluded it's 9-month active phase. subjects are currently in a 15-year long term follow-up phase of the study. in keeping with the recently released guidance on monitoring for delayed adverse events, that states that for the first 5 years all subjects should undergo monitoring of vector sequences every 6 months, subjects will visit the clinic at a maximum of 6 months intervals for a blood test evaluating persistence of vector sequences. therefore for the first 5 years, subjects will have 6 months visits for safety assessment. for years 6 to 15, subjects will be contacted by phone or mail. at these contacts, subjects will be asked about their health status.

Eligibility criteria:
inclusion criteria: * ability and willingness to give written informed consent in accordance with institutional and federal guidelines and to comply with the investigational nature of the study and the related requirements. * subjects who have successfully completed participation in the vrx496-usa-05-002 trial. * subjects who initiated or changed to a new arv regimen more than 3 months prior to entry assessment are eligible. * subjects that who (1) if on arvs and are willing to continue on the current therapy unchanged, or (2) if not on arv willing to remain off arvs for the duration of the trial i.e. 9 months. however, if there is clinical need to start or change arv therapy, then it is permitted to do so. exclusion criteria: * cd4 counts decreased by ≥25% from baseline in main study. * viral load increased by ≥ 1.0 log from baseline in main study or ≥ 200,000. * female subjects who are of reproductive potential who have a positive serum b hcg at the entry assessment visit or are not willing to use a reliable method of barrier contraception. * are breast-feeding. * subjects who are actively using injection drugs or other substance abuse (such as extensive alcohol or narcotic use). * any medical condition(s) which, in the opinion of the investigator, would interfere with the subject's ability to participate in or adhere to the requirements of this protocol * active hiv-related or non hiv-related illness * subjects who do not have additional cell product available

Keywords: hiv-1 treatment experienced, complementary therapies
pediatric obesity weight evaluation registry (power) study

Conditions: Overweight; Obesity

Summary: the main objective of this study is to establish a national pediatric obesity registry known as power (pediatric obesity weight evaluation registry). this registry will contain clinical data from individual comprehensive pediatric weight management programs around the united states for overweight and obese youth.

all patients 18 years of age or younger who have completed an initial medical assessment between march 1, 2014 through april 30, 2020 will be approached for this study. data from individual follow up visits or group intervention sessions, depending on the program design of each institution, will be collected through october 31, 2020. the data included in this study will be collected during routine medical care. information that could identify a participant will be removed from the data. data will be entered into a secure database called medidata rave® cdms. this database will be managed by the data coordinating center (dcc) at cincinnati children's hospital medical center (cchmc). the dcc will combine all the data from each site. additional data cleaning and data quality monitoring will be performed. combined datasets for analysis will be provided by the dcc in a format agreed upon by the power governance board. data will be stored in a secure and protected format and will not include any written or electronic protected health information (phi/ephi). the dcc will store the data on a secure server.

Eligibility criteria:
inclusion criteria: * age 18 years or younger * overweight or obese patient * initial medical evaluation in a pediatric weight management program between march 1, 2014-april 30, 2020. exclusion criteria: * no exclusion criteria

Keywords: overweight obesity
tableted covid-19 therapeutic vaccine

Conditions: Covid19

Summary: safety and immunogenicity one-month study in healthy individuals administered once-daily pill of therapeutic vaccine made from heat-inactivated plasma from donors with covid-19. healthy, at least 20, volunteers will be monitored for signs of adverse events. their pbmc will be collected at baseline and one month later to analyze which type of immune response vaccine has induced.

experimental batch of tableted thermostable vaccine obtained from pooled plasma of covid-19 patients is produced. the goal of this trial is test safety and immunogenicity of once-per-day day administered orally to volunteers for 15 days. baseline and post-treatment standard safety parameters will be compared. blood samples from volunteers will be monitored and immunogenicity lab assays will be undertaken to characterize immune response.

Eligibility criteria:
inclusion criteria: * confirmed cases of covid-19 (all by rt-pcr from same laboratory) * mild to severe clinical presentation (identified at the time of admission to ward by national early warning score news-2; mild 0-4; severe 5-6) exclusion criteria: * unable to take oral medication, * immunocompromised * known comorbid condition like hypertension, cardiovascular disease, diabetes mellites, asthma, copd, cerebrovascular disorder, malignancy of any type, pregnancy, * bmi less than 18 * smoking history (more than one pack per day)

Keywords: covid-19 sars-cov-2 coronavirus respiratory disease sars ards pneumonia pandemic
probiotics in obesity management

Conditions: Obesity

Summary: evaluate the effects of pasteurized akkermansia muciniphila akk11 (killed bacteria) capsules compared to placebo on body composition parameters (including weight, bmi, body fat percentage, waist - hip ratio (whr), wrist circumference, visceral fat area, and basal metabolic rate) and blood lipid levels (total cholesterol (tc), low - density lipoprotein (ldl), high - density lipoprotein (hdl), and triglycerides (tg)) in overweight or obese adults.


Eligibility criteria:
inclusion criteria: 1. a body mass index (bmi) of 25 kg/m² or above; 2. voluntarily signing an informed consent form to take part in the study; 3. willingness to undertake the study protocol and associated restrictions, such as adhering to a calorie - restricted - low carbohydrate diet; 4. no intention to become pregnant from 14 days before screening, and commitment to using effective contraception until six months after the trial concludes. exclusion criteria: 1. intake of products akin to the test product in the recent period that might sway the outcomes; 2. presence of mental or neurological disorders, celiac disease, lactose intolerance, or allergic conditions; 3. being pregnant, breastfeeding, or planning to conceive; 4. past diagnosis of irritable bowel syndrome, ulcerative colitis, hepatic cirrhosis, or diabetes mellitus; 5. use of antibiotics in the preceding three months; 6. inability to comply with the test product regimen or attend follow-up visits regularly, making efficacy assessment unfeasible; 7. smoking in excess of 10 cigarettes daily; 8. hypersensitivity to probiotic products; 9. any other participants deemed unsuitable for the research by the investigator.
cancer-related fatigue and symptom clusters - effects of virtual, imagined and real-life nature-based therapy in cancer survivors

Conditions: Cancer Survivors

Summary: this is a randomized, controlled, bicenter trial comparing the effects on symptoms and quality of life in cancer survivors. three nature-based therapies will be compared with a wait-list group. the therapies are: virtual reality simulated forest, guided imaging and classic forest bathing. each intervention lasts 30 minutes and takes place once a week for 8 weeks. all interventions involve different stimulus types: visual, olfactory, auditory and tactile.


Eligibility criteria:
inclusion criteria: * patients who have completed treatment for cancer (\*with the exception of long-term adjuvant endocrine therapy). * subjective impairment due to cancer-related fatigue (crf) . nccn-recommended questions are used for screening ("how exhausted do you feel on a scale of 0 to 10?" and "how impaired do you feel by this fatigue on a scale of 0 to 10?" (threshold \>4 on either scale). * at the time of study inclusion, it must be expected that no further antitumor therapy measures will be started within the next 6 months. * patients must be able to refrain from smoking up to 15 minutes before the intervention (smoking within 15 minutes before therapy impairs the participant's ability to perceive the aroma of the phytoncides). * written and valid informed consent from the patient. exclusion criteria: * presence of inadequately controlled major depression in the opinion of the investigator. * asthma (inhaled phytoncides may cause airway irritation, exacerbation of asthma, or bronchoconstriction). * known allergy to pine or citrus fragrance. * anosmie. * medical history of seasickness (virtual reality can cause nausea/vomiting with no improvement after 5-10 minutes). * history of seizures (virtual reality may increase susceptibility to seizures due to the changing light in the forest video). * visual and hearing impairments that are not corrected by visual or hearing aids. * unwillingness to store and share personal medical data as part of the protocol. * participation in another clinical trial focusing on behavioural or complementary medicine interventions. * missing or incomplete consent form.

Keywords: fatigue forest therapie virtual reality
amnion chorion membrane in comparison to subepithelial connective tissue graft in gingival recession coverage

Conditions: Gingival Recession

Summary: the present randomized, controlled, parallel-grouped trial included twenty patients (aged 20 to 54 years) suffering from miller's class i or ii gingival recession. patients were randomly assigned into two equal groups; control group; the coronally advanced flap with the subepithelial connective tissue graft (caf+sctg) or the test group; coronally advanced flap with amnion chorion allograft membrane (caf+ac).

the participants were randomly assigned to receive coronally advanced flap (caf) with amnion chorion membrane or caf with subepithelial connective tissue graft using a simple randomization procedure with a 1:1 allocation ratio. a computer generated randomization list was drawn up by a faculty member who was not involved in the recruitment. allocation concealment was achieved by sealed coded opaque envelopes that contained the treatment to be performed to the enrolled subjects based on the randomized numbers. consequently, patients were allocated to either ac membrane (intervention) or sctg (control) groups. the sealed envelope containing treatment assignment was opened at time of the surgery and the number was picked by another person other than the operator.

Eligibility criteria:
inclusion criteria: * subjects aged between 18 - 60 years old. * subjects with facial gingival recession defects in anterior and premolar teeth classified as either class i or ii defects according to miller's classification. * subjects able to tolerate surgical periodontal procedures. * accepts the 6 months follow-up period. exclusion criteria: * current and former smokers. * pregnant females. * subjects received any periodontal therapy for a minimum of 6 months prior to the study. * subjects taking drugs known to interfere with wound healing. * subjects with unacceptable oral hygiene with plaque index \>2. * teeth with non-carious cervical lesions, cervical caries and malalignment.
neuropsychological assessment of remediation for cognitive impairments in schizophrenia

Conditions: Schizophrenic Disorders

Summary: this study evaluates the effect of a cognitive remediation program on neurocognitive, social cognitive and metacognitive functions designed for patients living with a schizophrenia spectrum disorder.

evaluation of the specific therapeutic efficacy of the ecological cognitive remediation program for schizophrenia spectrum disorder \[eco-sz\] on neurocognitive deficits, social cognition deficits and metacognition deficits of patients with a schizophrenia spectrum disorder. in this double-blind (patients, outcomes assessors) controlled randomized trial the investigators compare patients receiving ecological cognitive training program for schizophrenia spectrum disorder \[eco-sz\] to patients benefiting from recovery-oriented therapy \[thor\]. patients are treated for two months and monitored for four months.

Eligibility criteria:
inclusion criteria: * schizophrenia disorder diagnosis, according to diagnostic and statistical manual of mental disorders - fifth edition (dsm-v) - patient stabilized in terms of positive and negative symptomatology (absence or presence of weak positive and negative symptoms) * positive and negative stable symptoms (no or few positive and negative symptoms) * stable and effective minimum dose of medication (antipsychotic) for the last three months * cognitive complaint expressed by the patient * informed consent form read, initialed and signed * understanding of spoken and read french * patient registered on the social welfare system exclusion criteria: * other diagnosis at the forefront than schizophrenia of the dsm-v * medical history neurological disorder resulting in hospitalization * acute episode in the last three month * somatic disorders resulting in cognitive impairment * engagement in a research protocol either currently or over the last month * neuropsychological assessment evaluation during the last six month * patients under the protection of a conservator (simple or reinforced) * individuals in vulnerable circumstances

Keywords: schizophrenia neurocognition social cognition metacognition cognitive remediation
optimizing a wellbeing program for care-partners of those with sci

Conditions: Internet-Delivered Cognitive Behavioural Therapy; Depression; Anxiety; Spinal Cord Injuries; Caregiver Burnout

Summary: spinal cord injuries (sci) have a devastating effect not only on individuals incurring the life changing event, but also on those who are involved in their care. family care-partners of those with sci (fcsci) may experience significant negative effects including impaired mental health, high levels of burden, poor adjustment to role, decreased quality of life and strain on relationships. cognitive behaviour therapy (cbt) is an evidence-based treatment strategy that helps individuals recognize and challenge their unhelpful thoughts and behaviours that contribute to their mental health concerns. however, barriers such as availability to specialized care, costs, rural and remote location, or concerns about stigma may limit access to care. internet delivered cbt (icbt) has the potential to reach a much wider group of people that may have unequal access to health care. in a previous feasibility study, the team demonstrated the preliminary effectiveness of a tailored icbt wellbeing program for fcsci. however, our understanding of which components of the program can result in optimal management is limited. the main purpose of this study is to evaluate the effectiveness of different components of the wellbeing program including: therapist guidance, peer support groups, and booster sessions on symptoms of depression among fcsci. the team will evaluate which intervention components result in meaningful improvement in symptoms of depression. through collaborations with sci community organizations and rehabilitation institutions, participants will be recruited across canada. the researchers will also develop a model to examine the most cost-effective intervention package from the different components. the wellbeing for fcsci program can provide personalized service to individuals while being flexible and easily accessible, improving overall wellbeing and access to health care services.


Eligibility criteria:
inclusion criteria: 1. 18 years of age or older 2. canadian residents 3. identify as fcsci 4. living in the community 5. endorsing symptoms of depression (phq-9≥5); 6. suicide risk score \<8 (suicide behaviours questionnaire (sbq) (osman et al. 2001) 7. speak and read english 8. able to access and be comfortable using computers and the internet 9. willing to provide the name of a physician as an emergency contact. exclusion criteria: 1. are currently involved in another psychotherapeutic intervention 2. present with severe mental health disorder requiring face-to-face therapy (e.g., severe suicide ideation, severe substance abuse, recent history of psychosis, mania). those participants taking antidepressants will be included in the trial; medication use will be tracked.
microbioma in sputa from copd with alpha-1 antitrypsin deficiency

Conditions: Alpha-1 Antitrypsin Deficiency

Summary: in the context of the increasing evidence of the pathogenetic role of microbiome in copd, our aim is to determine the total and specific bacterial and viral load in sputa from patients with copd due to aatd and to correlate these findings with cellular, biochemical and immunological characteristics of sputa. these quantitative data obtained from sputum will be analyzed in the context of the clinical and physiological parameters of the patients.


Eligibility criteria:
inclusion criteria: * diagnosis of copd and a clinical stable condition, i.e. at least three months from the last aecopd and/or antibiotic treatment. for patients with aatd this condition will be diagnosed by laboratory tests showing low levels of aat and genotyping of aatd-related genes. . exclusion criteria: * the presence of important co-morbidities (diabetes, systemic or organ infections, immunodeficiency, tumors, moderate-severe heart failure) will be considered as exclusion criteria.

Keywords: copd alpha-1 antitrypsin deficiency microbioma
an audit of patients with crohn's disease treated with infliximab (p06066)

Conditions: Crohn's Disease

Summary: the aim of this study is to quantify how infliximab therapy is being used in the uk and the consequent impact on health care resources, which will help to inform budget holders and payers on the costs associated with the treatment of crohn's disease.

all interested hospital physicians across the uk who prescribe infliximab as part of their treatment of crohn's disease patients. will be included. it is assumed that the physician population will consist primarily of gastroenterologists, though general physicians (hospital-based) with an interest in crohn's disease may also be included.

Eligibility criteria:
inclusion criteria: * diagnosis of crohn's disease. * over the age of 18 years. * must have received the first infusion of infliximab on or after 1st january 2003 (when the maintenance therapy license was granted). * must have received at least one infusion of infliximab. * a minimum of 12 months data prior to, and 24 months data post infliximab exposure should be available in the medical records. * must have been under the care of the participating center for the entirety of the study period. exclusion criteria: * should not have been involved in any clinical trial during the observational period (ie, a minimum of 12 months before and 24 months after first receiving infliximab). * should not have received any biologic therapy prior to infliximab.
hilt for meralgia paresthetica

Conditions: Meralgia Paresthetica; Lateral Femoral Cutaneous Nerve Entrapment

Summary: this randomized controlled trial aims to investigate the efficacy of high-intensity laser therapy (hilt) in the management of meralgia paresthetica (mp), a peripheral neuropathy causing pain, numbness, and tingling in the thigh region. participants with mp will be randomly allocated to either the hilt or sham hilt (control) group. the study will evaluate the effects of hilt on pain intensity, functional outcomes, and quality of life. findings from this trial will provide insights into the potential benefits of hilt as a non-invasive and safe treatment option for patients with mp.


Eligibility criteria:
inclusion criteria: * diagnosis of meralgia paresthetica, confirmed by a neurologist or a specialist in neuromuscular disorders, based on clinical signs and symptoms, and supported by nerve conduction studies. * presence of pain, numbness, or tingling in the anterolateral thigh for at least three months. * aged between 35 and 55 years. * willing and able to provide informed consent. * able to comply with the study protocol and attend all treatment sessions and follow-up assessments. exclusion criteria: * previous surgical treatment for meralgia paresthetica. * concomitant lower back or hip pain due to other causes, such as lumbar radiculopathy, hip joint pathology, or trochanteric bursitis. * presence of other neuromuscular or nerve compression disorders such as diabetic neuropathy * significant trauma or surgery to the affected thigh or lumbar spine within the past six months. * pregnancy or planning to become pregnant during the study period. * known contraindications to high-intensity laser therapy, such as active skin infection, malignancy, or photosensitivity disorders. * current use of anticoagulant medications or immunosuppressive therapy.