Kornimate/medical-research-clean huggingface dataset:
hiv and changes in the gut microbiome after changes in antiretroviral therapy (art)

Conditions: HIV Infections

Summary: this is a study that aims to contribute to the understanding of how antiretroviral therapy effects the gut microbiome which, if known, could inform decisions about drug choices at an individual level. the gut health is extremely important for all aspects of a persons wellbeing both at the level of the body and the brain. in recent years there has been much interest and better understanding of the role of the bacteria, viruses and other microorganisms that live in the human gut (the gut microbiome). it is known that disturbing the balance between the different species of bacteria in the gut can have consequences including diarrhoea, inflammatory and autoimmune conditions and has also been linked to obesity. there are big differences in the gut microbiome composition seen in people with untreated hiv infection compared with non-infected individuals. this disrupted balance does not seem to be restored when starting on antiretroviral therapy. different classes of antiretrovirals seem to have different effects but this has been hard to establish because studies aiming to look at this has been large population studies where it can be hard to tease out cause and effect. in this study the investigators are instead aiming to compare an individual with themselves by comparing the bacterial gut microbiome before the person switches from one class of antiretroviral treatment to another or switches the delivery method of that drug, with the bacterial gut microbiome 3-8 weeks after the switch. the investigators hope that if this can be understood the effects different classes and delivery methods of antiretroviral have on an individual's gut microbiome, can be taken into account when deciding on the best hiv therapy for a person. in the long term, this would lessen the negative effects of being on a life-long treatment.


Eligibility criteria:
inclusion criteria: * aged ≥18 years. * willing to undergo stool sample collection on two occasions. * able to give written, informed consent. * have evidence of hiv infection * have been on stable antiretroviral treatment for the previous ≥12months. * planning to switch art regimen from one class of drugs or delivery method to another. exclusion criteria: * hiv viral load \>50 copies/ml blood

Keywords: hiv gut microbiome antiretroviral drugs
resuscitative balloon occlusion of the aorta in non-traumatic out of hospital cardiac arrest

Conditions: Out-of-Hospital Cardiac Arrest

Summary: the primary aim of this study is to investigate the feasibility and complications of inserting a reboa-catheter to patients suffering from non-traumatic out-of-hospital cardiac arrest, by anesthesiologist working in the pre-hospital setting. the study will include patients in the catchment population of st. olavs university hospital, trondheim area, norway. the reboa technique (resuscitative balloon occlusion of the aorta) is a well-known treatment used on other indications, both in-hospital and pre-hospital. it has also been utilized in several animal studies on non-traumatic cardiac arrest and has shown to augment myocardial and cerebral perfusion during cardio-pulmonary resuscitation. there are no systematic studies on humans with reboa in non-traumatic cardiac arrest. the study will also investigate the time needed to perform a reboa procedure in cardiac arrest patients receiving advanced cardiac life support. this additional treatment might contribute to increase the survival rate of cardiac arrest patients.

if return of spontaneous circulation (rosc) is not achieved after advanced cardiac life support (acls as described in the present guidelines from the norwegian resuscitation council) is established, a reboa catheter is inserted via the femoral artery and the aortic balloon inflated, according to a procedure described in a separate document. ultrasound is used to limit risk related to cannulation and placement of the guidewire. the ultrasound images will be stored and later processed by the principal investigator. if the physician experiences technical problems during the procedure (i.e. severe difficulties in establishing vascular access, resistance during insertion of the guidewire, introducer or balloon catheter, severe bleeding, prolonged time consumption) the effort will be aborted. if rosc is achieved, the aortic balloon is deflated gently. if the patient re-enters cardiac arrest, the normal acls-guideline is followed. the balloon is then re-inflated, as described in the procedure.

Eligibility criteria:
inclusion criteria: * non-traumatic cardiac arrest * witnessed cardiac arrest * less than 10 minutes from observed cardiac arrest to start of basic or advanced cardiac life support (bcls/acls) exclusion criteria: * traumatic cardiac arrest, including patients rescued from avalanches * hypothermic patients, including drowning * pregnancy * end-stage terminal illness * suspected neurologic injury as the etiology of the arrest * strangulations * other factors as decided by the treating physician

Keywords: balloon occlusion air ambulances aorta resuscitation
study of venetoclax combined with azacitidine regimen in newly diagnosed t-all patients

Conditions: T-cell Acute Lymphoblastic Leukemia; Recruiting

Summary: the purpose of this study is to evaluate the efficacy and safety of venetoclax combined with azacitidine regimen for newly diagnosed t-all patients.

this is a phase 2, open label, single arm, multi-center study for newly diagnosed t-cell acute lymphoblastic leukemia patients. the patients will receive vanetoclax combined with azacitidine as the induction regimen.

Eligibility criteria:
inclusion criteria: 1. patients aged ≥ 15. 2. patients diagnosed with t-all according to 2016 who criteria for precursor lymphoid neoplasms. 3. ecog performance status score less than 3. 4. patients without serious heart, lung, liver, or kidney dysfunction. 5. ability to understand and voluntarily provide informed consent. exclusion criteria: 1. patients who are allergic to the study drug or drugs with similar chemical structures. 2. pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception. 3. patients with uncontrolled active infection 4. patients with active bleeding. 5. patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment. 6. patients with mental disorders or other conditions whereby informed consent cannot be obtained and where the requirements of the study treatment and procedures cannot be met. 7. liver dysfunction (total bilirubin \> 1.5 times the upper limit of the normal range, alt/ast \> 2.5 times the upper limit of the normal range or patients with liver involvement whose alt/ast \> 1.5 times the upper limit of the normal range), or renal anomalies (serum creatinine \> 1.5 times the upper limit of the normal value). 8. patients with a history of clinically significant qtc interval prolongation (male \> 450 ms; female \> 470 ms), ventricular heart tachycardia and atrial fibrillation, ii-degree heart block, myocardial infarction attack within one year before enrollment, and congestive heart failure, and patients with coronary heart disease who have clinical symptoms and requiring drug treatment. 9. surgery on the main organs within the past six weeks. 10. drug abuse or long-term alcohol abuse that would affect the evaluation results. 11. patients who have received chemotherapy treatments related to the disease.

Keywords: venetoclax azacitidine t-all newly diagnosed
this is a phase 1 study in which healthy volunteers and participants with chronic hbv infection will receive ht-101 or placebo and will be assessed for safety, tolerability, pharmacokinetics (pk), and antiviral activity

Conditions: Chronic Hepatitis B

Summary: phase 1 study of ht-101 in healthy subjects and patients with chronic hepatitis b the trial consisted of two components. part a involved a single ascending dose study where healthy participants were administered one dose of ht-101 or placebo subcutaneously (sc). part b involved a multiple ascending dose study where participants with chronic hepatitis b virus infection were administered two dose of ht-101 or placebo every 4 weeks subcutaneously (sc).


Eligibility criteria:
inclusion criteria: subjects were eligible for inclusion into the study if they met each of the following criteria: part a sad: healthy participant * male participants weighed ≥ 50.0 kg, female participants weighed ≥ 45.0 kg; * participants who promise having used effective contraception for at least 1 month before screening, and have no plans for pregnancy or donating sperm or eggs, and will voluntarily use effective physical means of contraception (including the partner) during the study and for 3 months after the end of the study; part b mad: patient with chb * male subjects weighed ≥ 50.0 kg, female subjects weighed ≥ 45.0 kg, with a body mass index (bmi) between 19.0 and 28.0 kg/m\^2 (inclusive); * chronic hbv infection for \>/= 6 months; * the quantitation level of hbsag was \> 200 iu/ml and \< 5000 iu/ml; the quantitation level of hbv dna \< 2×10\^4 iu/ml; * subjects promised to use effective contraception for at least 1 month before screening, and have no fertility, donate sperm or eggs and voluntarily take highly effective physical contraception (including partners) during the trial and within 3 months after the end of the trial; exclusion criteria:subjects were excluded from the study if one or more of the following criteria were applicable * participants with history of drug allergy or specific allergy; * participants who had psychiatric conditions or diseases in cardiovascular, respiratory, endocrine, kidney, liver, digestive tract, skin, immune, blood, nerve and other systems; * participants with history of active pathological bleeding, or bleeding tendency; * participants with abnormal results of physical examination, vital sign examination, ecg examination, laboratory test in the screening period which were judged as clinically significant by clinicians; * participants with significant liver fibrosis or cirrhosis; * participants with symptoms or a history of hepatic decompensation; * participants with a history or suspected risk of liver cancerr;
selinexor in combination with r-chop as the first-line therapy for tp53-mutated dlbcl patients (smart trial)

Conditions: Diffuse Large B Cell Lymphoma

Summary: this is a prospective, single-arm, multi-center, phase ii clinical trial to evaluate the efficacy and safety of selinexor in combination with r-chop (rituximab, cyclophosphamide, vincristine, doxorubicin, and prednisone) followed by selinexor maintenance for untreated tp53-mutated diffuse large b-cell lymphoma (dlbcl) patients.

the purpose of this phase ii clinical trial is to evaluate the efficacy and safety of selinexor in combination with r-chop for untreated tp53-mutated dlbcl patients. the induction phase consisted of 8 cycles of selinexor in combination with r-chop. after 8 cycles of induction therapy, if the response is assessed as complete remission (cr), maintenance therapy with selinexor will be conducted. the primary endpoint is complete response rate.

Eligibility criteria:
key inclusion criteria: 1. subjects fully understand and voluntarily participate in this study and sign informed consent. 2. aged ≥18, and ≤70 years, no gender limitation. 3. patient was histologically confirmed diagnosis of diffuse large b-cell lymphoma (dlbcl) and had tp53 mutations. 4. there must be at least one measurable or evaluable lesion that meets the evaluation criteria for lugano 2014 lymphoma. 5. eastern cooperative oncology group (ecog) performance status (ps) 0-2. 6. expected survival ≥ 3 months. 7. adequate function of bone marrow, liver, and kidney. key exclusion criteria: 1. dlbcl combined with other types of lymphoma. transformed dlbcl. 2. dlbcl with central nervous system invasion. 3. the patients had previously received xpo1 inhibitors. 4. the patients have contraindications to any drug in the combined treatment. 5. patients with chronic active hepatitis b or active hepatitis c. if the background hepatitis b surface antigen (hbsag) and/or hepatitis b core antibody (hbcab) or hepatitis c virus (hcv) antibody are positive, the further determination for hepatitis b virus (hbv) dna (no more than 2500 copies /ml or 500 iu/ml) and hcv rna (no more than the lower limit of the assay) can be included. the patients with hbsag and/or hbcab positive need to receive anti-hbv drugs. 6. patients with the infection of human immunodeficiency virus (hiv) and/or acquired immunodeficiency syndrome. 7. inability to swallow tablets, presence of malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may affect the absorption of the study drug. 8. pregnant and lactating women, and subjects of childbearing age who do not want to use contraception. 9. mentally ill persons or persons unable to obtain informed consent. 10. the investigators think that the patient is not suitable for the study.

Keywords: tp53-mutated diffuse large b-cell lymphoma selinexor
comparison of th1 cytokine levels between type 1 and type 2 diabetes

Conditions: Type 1 Diabetes; Type 2 Diabetes

Summary: recent reports show increased prevalence of obesity in patients with type 1 diabetes (t1dp)s while some studies stated that patients with type 2 diabetes (t2dps) have islet cell auto-antibodies. these results raise the question of a common pathway in t1dm and t2dm via an association with t helper cells. in this study investigators aimed to investigate the difference between t helper 1 (th1) cytokines levels in t1dps, t2dps and healthy subjects. the study included 114 t1dps on insulin treatment, 35 newly diagnosed t2dps who had not used oral antidiabetics but insulin before and 31 healthy subjects (cg). serum interferon gamma (ifn-γ), interleukin-2 (il-2) and tumor necrosis factor alpha (tnf-α) levels were measured using elisa method. serum levels of those cytokines in t1dps were compared with those in t2dps and controls.


Eligibility criteria:
inclusion criteria: * being \>18 years old * giving consent to participate exclusion criteria: * acute and chronic inflammatory diseases * significant concomitant disease likely to interfere with glucose metabolism, * malignancies, * hemoglobinopathies, * in addition, glucose intolerance (fasting glucose level and that after glucose load) and hba1c ≥ 5.7 % were also used exclusion criteria in the control group, group as american diabetes association (ada) defined prediabetes as hba1c between 5.7-6.4% (standards of medical care in diabetes -2012. diabetes care. 2012:35.)

Keywords: type 1 diabetes type 2 diabetes t helper 1 cytokines
predictive value of prostate-specific antigen isoform p2psa and its derivates in the diagnosis of prostate cancer

Conditions: Prostate Cancer

Summary: in europe, prostate cancer (pca) is the most common solid neoplasm, with an incidence rate of 214 cases per 1000 men, outnumbering lung and colorectal cancer. early detection tests have been developed in order to identify pca while it is still confined to the prostate gland. the two most commonly used tests are digital rectal examination and serum prostate-specific antigen (psa) level: however, most of cases is detected in the so called t1c stage, i.e. for psa increasing only. as marker, psa is organ-specific but not cancer-specific, and its levels may change as result of physical activity, sexual activity, in the presence of benign prostatic hyperplasia (bph), acute and chronic prostatitis, as well as in the presence of pca. a total serum psa of 4.0 ng/ml has traditionally been used as threshold for considering prostate biopsy and large programs for the early detection of prostate cancer have shown that almost 70% of cancer cases can be detected using a psa cutoff of 4.0 ng/ml. however, using a psa threshold of 4.0 ng/ml 20% to 25% of prostate cancer cases are not detected (false-negative) and the false-positive rate is 65%. to improve the usefulness of psa for identifying patients who require biopsy, the psa threshold has been lowered at 2 ng/ml; moreover, the levels of free and bound psa have been assessed, together with psa density (the rate of psa over the prostate volume) and psa velocity (the rate of psa increase), which seem to have some validity for detecting prostate cancer. recent studies have shown that other new biomarkers could be used in the diagnosis of early prostate cancer as they showed a higher sensitivity and specificity. in the last two years, several investigators showed that psa isoform \[-2\] propsa (p2psa) and its derivatives, namely, percentage of p2psa to free psa (%p2psa) and the prostate health index \[phi; (p2psa / free psa) × √tpsa)\] improve the accuracy of total psa (tpsa) and percentage of free psa (%fpsa) in predicting the presence of pca at prostate biopsy and they are also related to pca aggressiveness at biopsy. the aim of this study is to confirm the diagnostic and prognostic predictive value of prostate-specific antigen isoform p2psa and its derivates, %p2psa and prostate health index in the detection of prostate cancer in patients with a psa 2-10 ng/ml and/or suspicious dre.


Eligibility criteria:
inclusion criteria: * men aged 18-75 * total serum psa of 2.0-10 ng/ml at entry and/or suspicious digital rectal examination * patients suitable for prostate biopsy exclusion criteria: * history of pca * previous prostate biopsy or prostatic surgery * history of acute urinary retention within 3 months prior * use of any investigational or marketed 5ari, anabolic steroids or any drug with anti-androgenic properties within 12 months prior to screening.

Keywords: prostate cancer, psa, markers, diagnosis, prognosis, pro-psa
retrospective analysis of dabrafenib +/- trametinib compassionate use experience in spain

Conditions: Malignant Melanoma Stage IV; Malignant Melanoma Stage IIIc

Summary: the purpose of this study is to analyze whether dabrafenib +/- trametinib are effective in overall survival, response rates and toxicity in both programs.


Eligibility criteria:
inclusion criteria: * patients who have received at least one dose of dabrafenib or combination with trametinib as part of a compassionate use for the treatment of metastatic melanoma, with deadline the start of treatment the april 30, 2014. exclusion criteria: * patients with a history not available.
delivra joint health cream in the treatment of pain caused by osteoarthritis of the knee

Conditions: Osteoarthritis

Summary: the current clinical trial is designed to test the analgesic and anti-inflammatory efficacy of a topical cream compared to a placebo cream. the study population will be those with mild to moderate osteoarthritis of the knee. the trial will also provide information about potential side effects and verify the safety of this composition. blood levels will be done to assess inflammation and to determine whether any systemic absorption has occurred. hypothesis/purpose * pain scores after active treatment will be significantly reduced in comparison to placebo. * there will be an improvement in stiffness and physical function as measured by the womac using the active cream as compared to placebo. * there will be a decrease in the level of inflammation assessed at baseline, end of week 3 and end of week 6. * the blood concentration of the active ingredient in the topical cream will not exceed the maximum daily dose that will be consumed by participants.


Eligibility criteria:
inclusion criteria: * osteoarthritis of the knee according to american college of rheumatology criteria: knee pain with 3: * age \>50 years * stiffness less than 30 min * crepitus, * bony tenderness, * bony enlargement, * no palpable warmth * moderate to severe pain, as defined by an average 7-day pain score of greater than 4.0 on an 11-point numerical rating scale for pain intensity (nrs-pi). * all concurrent medications taken for any reason stable for 14 days * ability to follow protocol with reference to cognitive and situational factors (eg. stable housing, ability to attend visits) * ability to read and write english * willing and able to give informed consent exclusion criteria: * currently taking opioids, nsaids, warfarin, other anticoagulants, other topical agents for treatment of pain or inflammation * allergy to tea tree oil, latex, avocado, soy * active conditions such as exzema or psoriasis * presence of significant medical disorder that would compromise the participant's safety to take part in the trial (eg. cancer, immunosuppressed) * individuals with a history or current disease which may affect the outcome of the trial (ie. inflammatory, infections joint disease). * allergy to plants of the asteraceae/compositae/daisy family. * pregnant and breastfeeding women. * allergy or other contraindication for acetaminophen use. * exercise or transcutaneous electrical nerve stimulation should be excluded prior to and during the trial.
parental attitudes and beliefs regarding risks associated with opioid use in children with cancer

Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Summary: this study investigates parents' attitudes and beliefs on the risks of opioid use in children with cancer. pain is the common symptom reported by pediatric cancer patients. opioids are the mainstay in the treatment of cancer-related pain. despite an almost universal desire to prevent or mitigate pain in their children, parents exhibit complex behaviors from withholding prescribed opioids entirely to giving less than the prescribed analgesic dose of opioid to discontinuing despite ongoing pain. information gathered from this study may help address a crucial knowledge gap in researchers' understanding of parental attitudes and beliefs regarding the risks associated with opioid use in children and adolescents.

primary objective: i. to determine parents' level of concern regarding the use of opioids for pain in their children. secondary objectives: i. to explore differences in parents' level of concern regarding the use of opioids for pain in their children as well as level of concern for side effect of opioids between the opioid subgroup and non-opioid subgroup. ii. to explore differences in other parental attitudes and beliefs between the opioid subgroup and the non-opioid subgroup. iii. for each concern, associations between: iiia. level of concern regarding the use of opioids and the age and disease of the child. iiib. level of concern regarding the use of opioids and parental history of addiction. iiic. level of concern regarding the use of opioids and a family history of addiction. outline: parents complete survey over 20 minutes. patients' medical records are reviewed.

Eligibility criteria:
inclusion criteria: * parents must be at least 18 years old * the parent must be able to understand, read, write, and speak english * the parent must provide verbal informed consent * the child of the parents must be 18 years old or younger * the child must have a diagnosis of cancer exclusion criteria: a non-cancer diagnosis (neurofibromatosis, li-fraumeni syndrome for example).