Kornimate/medical-research-clean huggingface dataset:
psilocybin for the treatment of cluster headache

Conditions: Cluster Headache

Summary: the purpose of this study is to investigate the effects of an oral psilocybin pulse regimen in cluster headache. subjects will be randomized to receive oral placebo, low dose psilocybin, or high dose psilocybin in three experimental sessions, each separated by 5 days. subjects will maintain a headache diary prior to, during, and after the pulse regimen in order to document headache frequency and intensity before, during, and after the pulse regimen. after at least 6 months from the last experimental session, subjects may be invited for a second round, in which they will be randomized to receive either low dose or high dose psilocybin.


Eligibility criteria:
inclusion criteria: * chronic cluster headache with at least one attack daily * episodic cluster headache with periods that are predictable and have a duration of approximately 2 months * attacks are managed by means involving no more than twice weekly triptan use (e.g., high-flow oxygen, heat/cold pack) exclusion criteria: * axis i psychotic disorder (e.g. schizophrenia, bipolar i, depression with psychosis) * axis i psychotic disorder in first degree relative * unstable medical condition, severe renal, cardiac or hepatic disease, pacemaker, or serious central nervous system pathology * pregnant, breastfeeding, lack of adequate birth control * history of intolerance to psilocybin, lysergic acid diethylamide (lsd), or related compounds * drug or alcohol abuse within the past 3 months (excluding tobacco) * urine toxicology positive to drugs of abuse * use of vasoconstrictive medications (i.e. sumatriptan, pseudoephedrine, midodrine) within five half-lives of test days * use of serotonergic antiemetics (i.e. ondansetron) in the past 2 weeks * use of antidepressant medications (i.e. amitriptyline, isocarboxazid, fluoxetine, citalopram) in the past 6 weeks * use of steroids or certain other immunomodulatory agents (i.e. azathioprine) in the past 2 weeks
therapeutic vaccine trial of covid-19 for severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection

Conditions: COVID

Summary: gc004 is a phase i trial to evaluate the safety and the immune responses of a therapeutic vaccine in sars-cov-2 infected patients. covid-19 confirmed patients with mild or no symptoms will be enrolled sequentially into low dose and high dose groups. following the vaccination subjects who received at least one vaccination will be followed for safety through week 26.


Eligibility criteria:
inclusion criteria: 1. documentation of covid-19 infection based on laboratory evidence of positivity by rt- pcr. 2. patients who have no clinical symptoms (fever, cough and dyspnea). 3. patients who have mild clinical symptoms that could include fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, without shortness of breath (dyspnea). 4. screening laboratory values within institutional normal range or judged to be not clinically significant by clinical investigator. 5. ability and willingness of subject to give written informed consent. 6. negative pregnancy test on the day prior to each vaccination. 7. willingness to use adequate contraception by study participants. exclusion criteria: 1. history of respiratory and cardiovascular diseases, hematologic disease (e.g., cryoglobulinemia, lymphoma), renal disease, dermatologic disease (e.g., lichen planus, porphyria cutanea tarda). 2. autoimmune diseases or clinically serious cardiac, pulmonary, gastrointestinal, hepatic, renal or neurologic disease, which in the opinion of the investigator will compromise ability to participate in the study. 3. pregnancy and breast-feeding. 4. prior or current systemic cancer chemotherapy. 5. investigational agents and immunomodulators (cyclosporine, hematological growth factors, systemic corticosteroids, interleukins or interferons) within 90 days prior to study entry. 6. anaphylaxis or allergy to vaccine components. 7. active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements. 8. any other serious diseases other than covid-19 infection including current or recent (within 5 years) cancers. 9. subjects who are immunocompromised or immunosuppressed due to disease or medications. 10. women who are lactating.

Keywords: sars-cov-2 covid-19 therapeutic vaccine
phase ii study of azacitidine and sargramostim as maintenance treatment for poor-risk aml or mds

Conditions: Acute Myeloid Leukemia; Myelodysplastic Syndrome

Summary: to determine the impact of maintenance therapy in patients with mds/aml in remission.

we propose a phase ii study to determine the impact of maintenance therapy with 5-azacytidine and gm-csf in patients with poor-risk aml or mds, who are in remission after definitive treatment with either stem cell transplant or cytarabine-based consolidation chemotherapy. in order to precede relapse and to avoid lead time bias, treatment would need to commence within 185 days of definitive therapy. furthermore, approximately 50% of relapses occur within the first year and up to 80% within two years after sct, therefore we would limit the duration of maintenance therapy to one year, followed by two years of follow-up.

Eligibility criteria:
inclusion criteria: 1. age \> 6 months 2. initial diagnosis of poor -risk aml or mds (defined in section 3.2), treated with either stem cell transplant or cytarabine-based consolidation chemotherapy, within the past 60-185 days 3. ecog performance status 0-2 4. no morphologic evidence of leukemia or active mds as determined by jhh hematopathologist independent review of a bone marrow aspirate and biopsy done following the completion of therapy and within 14 days prior to enrollment 5. peripheral blood count recovery: neutrophil count ≥ 1000 /µl, platelet count ≥ 50x 109 /µl without platelet transfusions, and adequate hematocrit independent of red cell transfusions . 6. no evidence of extramedullary leukemia, such as cns or soft tissue involvement 7. adequate end organ function as measured by the following: ast and alt \< 4 x normal, total serum bilirubin \< 2 x upper limit normal (unless due to hemolysis, gilbert's syndrome, or ineffective erythropoiesis), creatinine \< 2 x upper limit of normal 8. ability to give informed consent 9. in agreement to use an effective barrier method of birth control to avoid pregnancy during the study and for a minimum of 30 days after study treatment, for all male and female patients who are fertile exclusion criteria: 1. patients with untreated or uncontrolled infections 2. patients with untreated or uncontrolled grade 3 or 4 gvhd 3. pregnancy and lactation 4. concurrent use of any other investigational agents. 5. known hiv-positive patients. 6. known hypersensitivity to 5ac or gm-csf

Keywords: maintenance treatment stem cell transplant cytarabine-based chemotherapy
time up and go in hemiplegic patients

Conditions: Difficulty Walking

Summary: investing the timed up and go (tug) test in hemiplegic patients using 3d motion analysis

the timed up and go is a routine quick test assessing motor functional tasks including stand up ,walk 3 m,turn around and sitting down.we will included hemiplegic patients to quantify biomechanic parameters

Eligibility criteria:
inclusion criteria: * patients performing 3d gait analysis * male or female adults aged ≥ 18 years, * hemiplegia following unique stroke- patients with hemiplegia able to stand up alone,walk and turn around alone without assistance. exclusion criteria: * patient with a protective measure, * pregnant women, breastfeeding * brain damage bilateral cerebellar syndrome, apraxia and / or severe aphasia, * patient who received botulinum toxin injection in the 3 months prior to inclusion, patients who underwent surgery of the locomotor system in the 6 months prior to inclusion, * no affiliation to a social security * other pathology, complications with significant impact on the activities of walking.

Keywords: hemiplegic time up and go test motion analysis center of mass
i save - irbesartan in mild to moderate hypertensive patients

Conditions: Hypertension

Summary: * to evaluate control rate of blood pressure ≤ 140/90 mm hg in non-diabetic patients, and ≤ 130/80 mm hg in diabetic patients. * to determine percentage of patients achieving blood pressure control according to their profile (naïve, switch, patient history, etc...) at the end of the trial.


Eligibility criteria:
inclusion criteria: * patients with proved mild to moderate hypertension. * newly diagnosed "naïve" hypertensive patients (no prior treatment for hypertension)or * patients who were receiving antihypertensive agents (maximum two - one of them is diuretic) and who in the investigator's opinion would benefit more from switching to the study medication. these patients will undergo a wash out period for not less than 7 days prior to enrollment. exclusion criteria: * severe hypertension (systolic blood pressure ≥ 180 mm hg or diastolic blood pressure ≥ 110 mm hg). * patients with secondary hypertension (for another cause other than type 2 diabetes mellitus). * patients with hba1c \> 10%. * significant chronic renal impairment (serum creatinine \> 2.0 mg/dl). * significant liver disease as shown by sgpt/sgot (alat/asat) \> 2.5 times the upper limit of the normal range. * currently pregnant or lactating females. * women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy. * any patient who is in need for a combination antihypertensive therapy from the start (from the medical point of view of his physician). * known hypersensitivity to irbesartan, other arbs (angiotensin receptor blockers), hydrochlorothiazide, or other thiazide diuretics. * patients with malignancy during the past 5 years, known collagen disease or severe cardiac, cerebrovascular or gastric disease. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
changes in patients' quality of life with differences in seton application

Conditions: Quality of Life; Anal Fistula

Summary: investigators aim to investigate the changes in patients' quality of life with different type of seton application.

perianal fistula is a very common disease. perianal fistula develops in the 50% of the anorectal abscess. perianal fistulas are usually complications of recurrent anorectal abscesses. the management of the fistula is sometimes challenging and requires a long period of time. one of the treatment methods in perianal fistula is seton application. seton is a rubber band made of various materials such as silicone, silk, latex, etc. it is passed through the fistula tract, and then the tips are tied to each other. seton is usually kept there for 3 - 6 months depending on the condition of the fistula. seton causes a foreign body reaction. after this process, there are various fistula management methods. seton application is again one of the choices besides fistulotomy, fistulectomy, ablation methods, etc. as seton is a frequently preferred method, patients should get used to living with seton. severe irritation and a decrease in quality of life are observed in patients depending potentially on the seton binding methods. investigators aim to evaluate the seton application methods that will minimize the decrease in the quality of life in this difficult process for patients by comparing 3 different seton application methods that investigators apply in daily practice.

Eligibility criteria:
inclusion criteria: * -primary perianal fistula exclusion criteria: * suprasphincteric fistula * patient who had previous perianal fistula surgery * crohn * radiotherapy * patient with pre-existing anal incontinence
clinical trial to study 4 different doses of the vaccine ruti in healthy volunteers

Conditions: Latent Tuberculosis Infection; Tuberculosis

Summary: the aim of this study is to evaluate the safety of a new vaccine against tuberculosis (ruti) when administered to healthy adult volunteers, compared to placebo; and determine its safe dosage range. an initial evaluation of immune responses to the vaccine compared to placebo will also be undertaken. in the present phase i clinical trial, four increasing doses of ruti will be tested, the groups composed by 6 volunteers each. (total of 24 volunteers). the escalation to a new dose to test will be done after the safety of the previous dose has been ensured. for each dose of fcmtb to test, each volunteer will be inoculated twice (at day 0 and day 28) with ruti (4 volunteers) or placebo (2 volunteers) and will be followed-up up to 25 weeks from the first inoculation. the global length of the study will be approximately 15 months.

ruti is a therapeutic vaccine made from virulent m.tuberculosis bacteria, grown in stressful conditions, fragmented, detoxified, heat inactivated (fcmtb) and liposomed. ruti provides a strong humoral and cellular immune response against antigens from active growing and latent bacilli but also against structural antigens, as it has been proved in animal models of latent tuberculosis infection. the vaccine has been designed to be used against latent tuberculosis infection as a therapeutic vaccine after 1-month of chemotheraputic treatment, instead the current treatment based on 6-9 months of chemotherapy.

Eligibility criteria:
inclusion criteria: * signed informed consent * healthy, based on medical examination at inclusion * male caucasian subjects, aged between 18 and 40 years * willing and likely to be able to comply with the trial procedures exclusion criteria: * evidence of previous, current or latent tuberculosis, as radiological findings on chest x ray compatible with previous or current infection with tuberculosis * positive t-spot tb result * bcg-vaccinated subjects * history of severe organ-system diseases, including * history of allergic disorders or known hypersensitivity to any drug or vaccine, or to any of the vaccine to be studied components * personal or familiar history of autoimmune diseases, or positive antinuclear antibodies * hiv, hbv and hcv sero-positive * suspected or known current drug and/or alcohol abuse (as defined by an alcohol intake of \> 50 g a day * lost of more than 400 ml of blood within 12 weeks, or more than 250 ml within 4 weeks, before the recruitment * laboratory parameters outside of normal ranges considered clinically significant * intake of trial medication in other clinical trials within 1 month of the first vaccination * intake of any other drugs that could not be eliminated of the body before the first vaccination, especially anti-inflammatory nonsteroid and corticosteroid drugs * acute disease with \> 37ºc temperature within 72 hours before the first vaccination

Keywords: ltbi (latent tuberculosis infection) tb(tuberculosis) vaccine
six versus two weeks treatment with doxycycline in lyme neuroborreliosis

Conditions: Neuroborreliosis, Borrelia Burgdorferi

Summary: comparison of doxycycline 200 mg once daily for six weeks versus doxycycline 200 mg once daily for two weeks + placebo for four weeks. primary objective is to answer the question "is two weeks doxycycline treatment (currently suggested treatment) at least as effective as six weeks doxycycline treatment in lyme neuroborreliosis?".key secondary objectives are to provide a better understanding of the pathogenesis and long-term complaints, and to search for new biomarkers in lyme neuroborreliosis (lnb) by collecting clinical data, blood, and cerebrospinal fluid (csf) in a biobank for future research endpoints: primary endpoint: improvement on a composite clinical score from inclusion to six months after ended treatment defined as clinical score at inclusion minus clinical score at six months. secondary endpoints: improvement on a composite clinical score 12 months after ended treatment. fatigue severity scale (fss),patient health questionnaire (phq-15), short form 36 (sf-36) and blood and csf findings at inclusion, after 6 and 12 months. the study design is a multicenter, non-inferiority, randomized, penta-blind, placebo-controlled trial. 120 patients will be included from approximately 8 norwegian hospitals. main inclusion criteria are neurological symptoms suggestive of lnb without other obvious reasons, one or both of a) cerebrospinal fluid pleocytosis (\>5 leukocytes/mm3) b) intrathecal bb antibody production and signed informed consent. safety assessments during the trial: comparison of clinical outcome six months after end of treatment between the two treatment groups. subjective experiences and blood tests including hematology and biochemistry for four weeks after ended treatment.


Eligibility criteria:
inclusion criteria: 1. neurological symptoms suggestive of lnb without other obvious reasons and one or both of 1. cerebrospinal fluid pleocytosis ≥5 leukocytes pr mm3 2. intrathecal bb antibody production 2. signed informed consent exclusion criteria: * age less than 18 years * pregnancy, breast-feeding * adverse reaction to tetracyclines * treatment with cephalosporin, penicillin, or tetracycline the last 14 days * serious liver or kidney disease that contraindicates use of doxycycline * lactose intolerance * need to use medications contraindicated according to summary of product characteristics of the investigational medicinal product
maxillary sinus membrane perforation incidence during osseodensification

Conditions: Sinus Floor Augmentation; Sinus Infection

Summary: measure the incidence of the maxillary sinus membrane perforation during the osseodensification crestal sinus grafting procedure.

retrospective clinical study to : 1. investigate maxillary sinus membrane perforation incidence via osseodensification crestal sinus grafting utilizing the densah bur. 2. assess the osseodensification technique efficacy for maxillary crestal sinus grafting with implant site preparation. 3. study and analyze the maxillary sinus perforation rate during or post-osseodensification-mediated sinus grafting as a function. 4. to share the knowledge from this retrospective analysis through scientific publications.

Eligibility criteria:
inclusion criteria: 1- medically healthy patients treated with crestal sinus augmentation via osseodensification using the densah burs and implant placement. exclusion criteria: 1. history of radiotherapy, 2. bisphosphonate medication. 3. active periodontal disease. 4. uncontrolled diabetes. 5. heavy smoking (\> 20 cigarettes/day). 6. local acute apical abscess.
probiotics on body composition and insulin resistance in patients with obesity and its association with gut microbiota

Conditions: Obesity; Insulin Resistance; Microbial Colonization

Summary: this study aims to evaluate the modifications in body composition and insulin resistance state in patients with grade ii and iii obesity included in an interventional lifestyle changes program and treated with probiotics (1 x 1011 cfu) or placebo for 16 weeks and its associations with intestinal microbiota behaviour

a randomized placebo-controlled clinical trial will take place in which both arms will be included in an interventional lifestyle changes program at the clinic for integral treatment of patients with diabetes and obesity. the study group will be treated with probiotics (1 x 1011 cfu) for 16 weeks and will be compared to a control group who will receive placebo. changes in body composition (weight, bmi, fat percentage, fat mass, lean body mass) and insulin resistance indexes (homa, insulin sensitivity index and quicki) will be evaluated in patients with obesity receiving probiotics (1 x 1011 cfu) for 16 weeks, and compared to a placebo group. changes in metabolic profile (glucose tolerance test, glycosylated haemoglobin, lipid profile, leptin and transaminases) in patients with obesity receiving probiotics (1 x 1011 cfu) for 16 weeks, and compared to a placebo group. changes in micrornas profile (mir-133 and mir-27 in patients with obesity receiving probiotics (1 x 1011 cfu) for 16 weeks, and compared to a placebo group. the threshold for basic tastes will be evaluated (salted, bitter, acid, sweet) and will be evaluated in those patients receiving probiotics (1 x 1011 cfu) for 16 weeks, and compared to the group receiving only placebo. changes in intestinal microbiota behaviour will be evaluated in participants with obesity receiving probiotics (1 x 1011 cfu) for 16 weeks, and compared to the group receiving placebo.

Eligibility criteria:
inclusion criteria: * patients with grade ii y iii obesity (imc \> or = 35 kg/m2), who receive the initial evaluation at the integral attention clinic for diabetes and obesity at hospital general de méxico * patients who signed informed consent. exclusion criteria: * diabetes mellitus 2 * secondary causes of obesity (hypothyroidism, cushing syndrome). * patients receiving pharmacological treatment that may affect lipid or glucose metabolism. * patients who received broad-spectrum antibiotics during the 4 previous weeks. * ingestion of products that contain probiotics. * relevant changes in diet habits during the 4 previous weeks * intestinal malabsorption disorders ( inflammatory bowel disease, chronic diarrhea, c. difficile infection).