Kornimate/medical-research-clean huggingface dataset:
a phase 1 study of novel gs-9973 tablet formulations to evaluate the effect of acid reducing agents, relative bioavailability, and food effect on gs-9973 pharmacokinetics

Conditions: Chronic Lymphocytic Leukemia

Summary: this is a phase 1, open-label, adaptive study of novel gs-9973 tablet formulations to evaluate the effect of acid reducing agents, relative bioavailability, and food effect on gs-9973 pharmacokinetics.


Eligibility criteria:
inclusion criteria: * have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures * must have a body mass index (bmi) range of approximately 19 to 30 kg/m2 * must have a minimum weight of 45 kg * females of childbearing potential must have negative serum pregnancy tests at screening and baseline and must practice at least 1 reliable method of contraception as defined by the protocol * female subjects who utilize hormonal contraceptive as 1 of their birth control methods must have used the same method for at least 3 months prior to study dosing * male subjects must agree to use condoms during heterosexual intercourse and avoid sperm donation from day -1 until 90 days following the last dose of study medication * must refrain from blood donation throughout the study period * must, in the opinion of the investigator, be in good general * must be a non- or light smoker, eg, less than 10 cigarettes per day exclusion criteria: * pregnant or lactating subjects * use of prescribed or over-the-counter medications that affect gastric ph * history of severe peptic ulcer disease, gerd, or other diseases requiring prolonged(\>6 weeks) medication or surgical therapy to modify gastric ph * have a history of clinically significant cardiac abnormalities or presence of clinically significant abnormality on 12-lead ecg. * have a history of any cancer requiring systemic chemotherapy or radiation * have a history of bleeding disorders * have a history of liver disorders * current acute infection or history of acute infection within 7 days * have a recent history of alcohol or illicit drug abuse and/or have a positive test for selected drugs of abuse * have a positive hepatitis screen or positive human immunodeficiency virus antibody test * have participated in another clinical trial within 28 days * have received transfusion of blood or plasma products within 6 months * have donated \> 500 ml blood within 56 days * are unable or unwilling to comply with study restrictions, return for follow-up appointments, or other considerations, which in the opinion of the investigator, would make the candidate unsuitable for study participation * current or historical medical condition that is deemed to be of medical significance by the investigator * have used prescription medications, over the counter products, herbal remedies and nutritional supplements within 7 days

Keywords: chronic lymphocytic leukemia cll
clinical study on 68ga-psma-33 for pet/ct imaging of prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to determine the pharmacokinetics, dosimetry, tolerance, tumor detection rate of 68ga-psma-33 in patient with prostate cancer (pca).

this study is design to prospectively investigate the safety and efficacy of 68ga-psma-33 in the early diagnosis of prostate cancer (pca). the specific objectives are the determination of pharmacokinetics, dosimetry, tolerance and tumor detection rate of 68ga-psma-33 in patient with pca. while psma is expressed at low levels in normal prostate epithelium, it is overexpressed (up to 1000 times higher) in 90-95% of prostate cancers, make psma an attractive target for the diagnosis and treatment of pca. 68ga-psma-33 as a new psma targeted probe was prepared and showed good uptake on pca cell line and animal studies. the study intends to recruit 8 pca volunteers to participate in the experiment. all patients were intravenously injected with 68ga-psma-33 and underwent pet/ct at 0.5, 1, 2 and 4 h, respectively. for comparison, 3 patients were additionally received 68ga-psma-617 pet/ct imaging. the images were interpreted by two experienced physician and the suvmax or suvmean of physiological organs and tumor lesions were collected.

Eligibility criteria:
inclusion criteria: * male sex * age 18 years or older * patients must have histologically or cytologically confirmed localized or metastatic prostate cancer * creatinine less than or equal to 1.5 x upper limit of normal * ecog performance status 0 - 2, inclusive * able to tolerate the physical/logistical requirements of a pet/ct scan including lying supine (or prone) for up to 30 minutes and tolerating intravenous cannulation patient with complete clinical data. * the effects of 68ga-psma-33 on the developing human fetus at the recommended therapeutic dose are unknown. for this reason, men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. * able to understand and provide written informed consent exclusion criteria: * patient age \< 18 years * received radioisotope diagnosis or treatment before enrollment, and the time window did not exceed 10 physical half-lives * malignancy other than current disease under study * patient simultaneously participating in another clinical trial * patient who cannot stay on pet/ct * patient with hiv, hcv, hvb infection or other serious chronic infection * patient with liver and kidney function (gfr less than 50 ml/min) disease * cannot receive furosemide, allergy to sulfa or sulfa-containing medications * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Keywords: prostate-specific membrane antigen (psma) pet/ct prostate cancer
capflex pip implant rsa

Conditions: Osteoarthritis Hand

Summary: rationale: patients with osteoarthrtis (oa) of the proximal interphalangeal (pip) joint are commonly treated with joint arthroplasty. the capflex pip implant is a modular surface replacing implant, which has good short-term functional results with a relatively low complication rate. to reduce implant failure and to increase long-term survival, it is important to expand knowledge about fixation and loosening patterns. by using model-based roentgen stereogrammaetric analysis (mrsa), the migration pattern of the implant over time can be calculated. objective: the primary objective is to assess the fixation and migration patterns of the capflex pip implant system (produced and developed by several companies of kls martin group) in vivo, using mrsa, over 10 years. secondary objectives are to analyse survival, clinical scores and radiographic aspects of the capflex pip implant system. study design: a prospective cohort study with 10 years follow-up, in which 36 patients will be enrolled. patients will be evaluated preoperatively, at 6 weeks, 6 months, 1 year, 2 years 5 years and 10 years. study population: patients 18 years or older who require a proximal interphalangeal joint arthroplasty as a result of osteoarthritis of a proximal interphalangeal joint. main study parameters/endpoints: the main study parameters are the migration of the capflex pip implant system of the distal as well as the proximal component (presented in x-, y- and z-direction). secondary study parameters are the survival of the capflex pip implant system, clinical scores and radiographic aspects. nature and extent of the burden and risks associated with participation, benefit and group relatedness: patients participating in the study will have the same risks when not participating in the study. patients are asked to spend time to fill in the questionnaires and to have 3 extra visits to the hospital, next to the standard visits. patients will have more follow up visits and will be followed using rsa analysis, which has as advantage that possible complications might be noticed earlier compared to normal follow up.


Eligibility criteria:
inclusion criteria: * indication for pip joint arthroplasty as described in the manufacturer's guideline, namely as a result of: * painful osteoarthritis * instable communitive intra-articular pip fractures * age \> 18 years * patient is able to speak and write dutch * patient is willing to participate * patient is able and willing to provide written informed consent exclusion criteria: * inflammatory arthritis with significant bone loss * insufficient bone quality to provide adequate stability * known or suspected sensitivity or allergy to one or more of the implant materials * revision surgery * significant collateral instability * pregnancy or breastfeeding

Keywords: rsa osteoarthritis
vegf gene association with response to neovascular age-related macular degeneration with anti-vegf agents

Conditions: Macular Degeneration

Summary: the main purpose of this study is to investigate the association between vegf gene polymorphism and the response to intravitreal drugs in neovascular age-related macular degeneration. this is a retrospective review of patients treated between 2008 and 2012 at the institute of vision, in belo horizonte, brazil.


Eligibility criteria:
inclusion criteria: * diagnosis of neovascular age-related macular degeneration * visual acuity better than 20/400 * loading dose with three intravitreal injections of anti-vegf agents, administred one per month over three months * follow-up period of at least six months exclusion criteria: * choroidal neovascularization secondary to any other cause than age-related macular degeneration * eyes with polypoidal choroidal vasculopathy * eyes previously submitted to posterior vitrectomy * other diseases that could affect visual acuity
a dose escalation study of intravenous l-citrulline in steady-state sickle cell disease

Conditions: Sickle Cell Disease

Summary: the purpose of this study is to assess the maximum tolerated dose, safety and pharmacokinetics of an investigational drug, intravenous (iv) citrulline, in subjects in steady-state sickle cell disease.


Eligibility criteria:
inclusion criteria: * sickle cell disease genotypes (hbss, hbs/β° thalassemia, hbs/β+thalassemia, hbsc) exclusion criteria: * presence of any acute illness defined by fever \>100.4° f within the past 48 hours * presence of sickle cell pain crisis defined by the presence of pain requiring oral or parental opioid therapy. * presence of acute chest syndrome or presence of any other complication related to sickle cell disease requiring hospitalization such as splenic sequestration, hepatic sequestration, stroke, avascular necrosis of the hip/shoulder, acute priapism, and patients with diabetes etc. * severe anemia (hemoglobin \< 5g/dl) * history of red blood cell transfusion within the last 14 days * systemic steroid therapy within the last 48 hours * pregnant (as confirmed by a negative urine pregnancy test) or lactating female * alanine/aspartate transferase \>2x upper limit of normal laboratory range for age. * elevated serum creatinine \>1.5mg/dl * patients with an inability to give consent will be excluded * medications that are known to be contra-indicated with use of l-citrulline (concurrent use of hydroxyurea will be allowed). * history of diabetes due to risk of electrolyte imbalance
neoadjuvant sequential administration of two gemcitabine combinations in operable breast cancer

Conditions: Breast Cancer

Summary: gemcitabine and anthracycline combination has shown encouraging activity as neoadjuvant chemotherapy in locally advanced breast cancer. an addition of sequential gemcitabine and cisplatin, also a highly active combination in this indication, may result in improvement in pathological response and overall survival. patients with operable breast cancer will be treated in neoadjuvant setting with gemcitabine plus doxorubicin, followed by gemcitabine plus cisplatin.


Eligibility criteria:
inclusion criteria: * diagnosis of breast carcinoma * no previous chemotherapy, with bidimensionally measurable locally advanced disease * adequate performance status (karnofsky performance status \[kps\] greater than or equal to 70), bone marrow reserves, hepatic, cardiac and renal functions. exclusion criteria: * inflammatory breast cancer * pregnancy and breast-feeding * serious concomitant disorder or infection * previous cancer within the last 5 years or a second primary malignancy.
comparison of dtap-hb-prp~t combined vaccine to tritanrix-hepb/hib™, both given concomitantly with oral polio vaccine

Conditions: Diphtheria; Tetanus; Pertussis; Hepatitis B; Haemophilus Infections

Summary: the purpose of this study is to support the registration of the pentavalent dtap-hb-prp\~t vaccine in countries that follow the world health organization-expanded program of immunization (who-epi) schedule. the primary objective is: * to demonstrate that the pentavalent dtap-hb-prp\~t combined vaccine does not induce a lower immune response than tritanrix-hepb/hib™ in terms of the seroprotection rate to hepatitis b (hb) one month after a 3-dose primary series at 6, 10, and 14 weeks of age. the secondary objectives are: * to describe in each group the immunogenicity parameters one month after the 3-dose primary series at 6, 10, and 14 weeks of age; and * to evaluate the overall safety in terms of any adverse events in the first 28 days after each injection and any serious adverse events during the entire trial.


Eligibility criteria:
inclusion criteria: * six week old infants (42 to 50 days old) on the day of inclusion; of either gender. * mother tested as seronegative for hepatitis b surface antigen (hbsag) between 28 weeks of pregnancy and up to 4 days after delivery * born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg * informed consent form signed by one parent or other legal representative if appropriate (independent witness is mandatory if parent is illiterate) * able to attend all scheduled visits and to comply with all trial procedures. exclusion criteria: * participation in another clinical trial in the 4 weeks preceding the first trial vaccination * planned participation in another clinical trial during the present trial period * congenital or acquired immunodeficiency; immunosuppressive therapy such as long-term systemic corticosteroid therapy. * chronic illness at a stage that could interfere with the conduct or completion of the trial * blood or blood-derived products received since birth * hb vaccination since birth * any vaccination in the four weeks preceding the first trial vaccination * any planned vaccination (except trial vaccines and bacillus calmette-guerin (bcg) during the trial * documented history of pertussis, tetanus (t), diphtheria (d), polio, or haemophilus influenzae type b (hib) infection(s) (confirmed either clinically, serologically, or microbiologically) * known personal or maternal history of hiv, hbsag or hepatitis c seropositivity * thrombocytopenia or a bleeding disorder contraindicating intramuscular (im) vaccination * history of seizures * febrile (rectal temperature ≥ 38.0°c) or acute illness on the day of inclusion.

Keywords: diphtheria tetanus pertussis hepatitis b hansenula (hb) haemophilus influenzae type b haemophilus influenzae
efficacy comparison of the exercises based on the lumbar extension and flexion in chronic low back pain

Conditions: Low Back Pain

Summary: this study is to compare the efficacy of exercises based on the lumbar extension and flexion on the pain relief and the prevention of pain recurrence in chronic low back pain patients.

68 people that meet the inclusion criteria on screening test are assigned to one of two groups by randomization. each of the group learns one of the exercises based on the lumbar extension or flexion for four weeks. the main outcome variables are measured and compared respectively in baseline, immediately after the education, 3, 6, 12 months after the enrollment. finally lumbar extension exercise is verified whether it is more effective than the lumbar flexion exercise on the pain relief and the prevention of pain recurrence in chronic low back pain patients.

Eligibility criteria:
inclusion criteria: * chronic low back pain (\>6 months, vas score of 5 or above) * presence of discogenic or axial pain * duration of \>6 months exclusion criteria: * spondylolisthesis or retrolisthesis on radiograph * hx of spine surgery * hx of any spine intervention within 3 months * other neurological, inflammatory, or poor medical conditions * who cannot understand or conduct the protocol of the study
bicarbonates versus saline for contrast induced acute kidney injury prevention in intensive care unit

Conditions: Contrast Induced Acute Kidney Injury

Summary: the aim of this study is to compare bicarbonates versus saline for prevention of contrast induced acute kidney injury in critically ill patients.


Eligibility criteria:
inclusion criteria: * patient \> 18 years old * in intensive care unit since 24h and for up to 48 hours * with contrast medium injection exclusion criteria: * patient under renal replacement therapy * rise in creatinine \> 26µmol/l within 48hours * anuria within 12 hours * cardiogenic pulmonary oedema * ph \> 7.50 or kaliemia \< 3mmol/l * pregnancy

Keywords: intensive care unit
photobiomodulation and root resorption

Conditions: Orthodontic Pathological Resorption of External Root; Orthodontic Appliance Complication; Orthodontic Tooth Movement

Summary: objectives: the aim of this study is to investigate the effect of photobiomodulation therapies on root resorption compared with the placebo group. materials and methods: 30 patients, who were admitted to the ............. university faculty of dentistry orthodontics department for treatment, with an indication of upper right 1st premolar tooth extraction was included. before the individuals' orthodontic treatment, 0.022 slot mbt brackets and tubes were placed on the maxillary 1st premolar and molar. a 150g buccal tipping force was applied to the 1st premolar. individuals were then randomly divided into 3 groups. for the first group; laser application was performed with a 810 nm gaalas laser device at 0,3,7,14,21 and 28 days to 8 j/cm2. second group; an led application according to the manufacturer's instructions with a 850 nm wavelength and 20 mw/cm2 output power for 10 minutes per day during the experiment. third group; a placebo therapy was completed whereby a laser device that did not make active pulses was used. at the end of four weeks, the amount of root surface resorption was compared using micro-ct imaging after the extraction of the teeth.


Eligibility criteria:
inclusion criteria: * no history of orthodontic treatment * no systemic disease or craniofacial anomaly * no dental trauma and tooth with root resorption * having good oral hygiene * no periodontal disease (no more than 3mm pocket) * no restored or endodontically untreated upper right 1st premolar teeth * having the maxillary right 1st premolar tooth extraction indication of orthodontic treatment exclusion criteria: * problems in patient compliance * inadequate oral hygiene * development of any medical problem making orthodontic treatment contraindicated during the study period

Keywords: photobiomodulation laser led resorption micro-ct
tailored approach to sleep health education: a community engaged approach

Conditions: Healthcare Disparities; Minority Health; Sleep; Sleep Disorders

Summary: this study aims to develop educational tools and platforms to promote the transfer of sleep health information to blacks to foster adoption of healthful sleep practices.


Eligibility criteria:
inclusion criteria: * self-reported race/ethnicity as african american, african, caribbean american or black men and women; ages ≥18 years; * accessible by telephone; no plans to move away from the region within the year following enrollment; * consent to participate, which includes permission to release medical record information; * documented osa risk based on scores received from the apnea risk evaluation system questionnaire exclusion criteria: * progressive medical illness in which disability or death is expected within one year; * impaired cognitive or functional ability which would preclude meaningful participation in the study; * sleep apnea diagnosis; * stated intention to move within the same year of enrollment.
sublingual tablets with cannabinoid combinations for the treatment of dysmenorrhea

Conditions: Dysmenorrhea; Headache, Migraine; Fatigue; Nausea; Mood Disturbance

Summary: sublingual tablets with cannabinoid combinations for the treatment of dysmenorrhea


Eligibility criteria:
inclusion criteria: 1. subject is female and at least 21 years of age; 2. subject has a regular, predictable menstrual cycle ranging in length from 21-35 days; 3. subject has a diagnosis of primary dysmenorrhea with an average pain scale score of 5 or greater; 4. subject is willing to provide her informed consent via docusign to participate in the study as stated in the informed consent document. 5. subject knows how to use and is willing to use a smart phone app to record information. exclusion criteria: 1. subject is pregnant or lactating; 2. subject has an allergy to cannabis (marijuana), the cannabaceae plant family (e.g., hemp, hops), pea, terpenes, citrus, or lavender, peppermint; 3. subject has a known allergy to active or inert ingredients of pure femme tablets; 4. subject is taking a concomitant medication or treatment that would complicate use or interpretation of the study drug's effects (examples include: cannabis or any cannabinoid products including cbd and thc; any drug or herbal product that influences the endocannabinoid system (ecs)); 5. subject has a history of endometriosis, pelvic inflammatory disease, adenomyosis, leiomyomata, or chronic pelvic pain; 6. subject has a history of migraines, tension headaches, or cluster headaches not associated with menstruation or is currently taking medication for headache treatment or prevention (e.g., tricyclic antidepressants, beta-blockers, anticonvulsants, triptans); 7. subject is currently using any of the following medications or classes of medication routinely: opioids, anti-emetics, acetaminophen, nsaids, ergotamines, triptans, or, glucocorticoids; 8. subject has shortness of breath associated with allergies; 9. subject has uncontrolled asthma; 10. subject has a fever and/or productive cough.

Keywords: pain associated with dysmenorrhea cbd cannabidiol