Kornimate/medical-research-clean huggingface dataset:
choline dehydrogenase and sperm function: effects of betaine

Conditions: Men Carrying 2 Minor Alleles for Choline Dehydrogenase rs12676; Male Infertility

Summary: the ability of sperm to swim is important for normal fertility. men with a genetic variation in the gene coding for choline dehydrogenase (chdh) have decreased energy production by sperm, and their sperm do not swim normally. the metabolic product of this gene is a nutrient called betaine (found normally in the diet as a part of many foods such as spinach, beets and grain products). this study tests whether treatment with betaine is safe and whether it can normalize energy production in sperm of these men and restore normal swimming ability.

unidentified genetic aberrations such as single nucleotide polymorphisms (snps) may be the underlying cause of many cases of idiopathic infertility in men. choline dehydrogenase (encoded by chdh) converts choline to betaine in the mitochondria. 5-9% of men have 2 alleles for a functional snp in chdh (rs12676), and they have low sperm adenosine triphosphate (atp) concentrations with impaired sperm motility (asthenospermia) that should decrease fertility. male mice in which chdh is deleted also have very low sperm atp, asthenospermia and are infertile. supplementation of these mice with dietary betaine increases sperm motility and atp concentrations. this purpose of this study is to conduct a phase i study of betaine treatment in men with 2 minor alleles for chdh rs12676 to determine whether betaine supplementation is safe and to obtain preliminary data on the effects of betaine on sperm mitochondrial atp concentrations and sperm motility in these men.

Eligibility criteria:
inclusion criteria: * 18 - 60 year old men of multiple races and ethnicities * estimated dietary intake of betaine of \<150 mg/day * carrying two alleles of the rs 12676 single nucleotide polymorphism exclusion criteria: * cystathionine-beta-synthase (cbs) deficiency * currently taking betaine supplements * currently receiving chemotherapy, radiation or any gonadotoxic drug * female gender

Keywords: sperm motility
bv in the treatment of relapsed/refractory hodgkin lymphoma

Conditions: Hodgkin Lymphoma (Category)

Summary: the goal of this clinical trial is to explore the real-world chinese relapsed/refractory patients to evaluate the efficacy and safety of bv monotherapy or combination therapy in chl patients. the main questions it aims to answer are: to evaluate the efficacy and toxicity of bv-containing regimen in relapsed/refractory chl patients in china, and to provide reference for the rational and safe use of bv in clinical practice.

part i: retrospective study the clinical data of 50 cases of relapsed/refractory chl treated with bv in multiple centers in the past 3 years were collected. statistical methods were used to compare the efficacy and safety between groups and subgroups. part ii: prospective study the study was conducted in about 20 centers in china. the preliminary plan was to select a large grade a tertiary hospital with lymphoma specialty center as a sub-center, and an investigator meeting was held to further discuss the choice of drug administration and combination therapy for patients. it was initially planned that bv monotherapy would be divided into two groups: a 2-week (2w) dosing group and a 3-week (3w) dosing group. the specific dosing method was determined by the investigator, but the duration of dosing could not exceed 1 year. for the combined treatment group, it is recommended to use drugs with low neurotoxicity, such as bendamustine and gemcitabine, and dacarbazine and etoposide can also be selected. anti-pd-1 monoclonal antibody is recommended to be administered once every 3 weeks, and sintilimab or somatorellimab can be selected. patients who had failed previous treatment with anti-pd-1 anti-pd-1 monoclonal antibody could also be enrolled, at the discretion of the investigator. pet-ct is recommended for efficacy evaluation, and enhanced ct can also be used for patients with poor economic conditions.

Eligibility criteria:
inclusion criteria: * histologically, classical hodgkin lymphoma（chl） was diagnosed and relapsed or refractory. * patients were treated with bv-containing regimen at least once * presence of tumor (measurable or nonmeasurable). * signature of the form consent for participation in the study. exclusion criteria: * \<18 years

Keywords: brentuximab vedotin hodgkin lymphoma refractory recurrence real world china
validation of portable monitoring device for diagnosing sleep apnea

Conditions: Sleep Apnea

Summary: portable monitoring device could diagnose sleep apnea in high risk patients.

this is a pilot study of another larger cohort investigating different algorithms in managing patients suspected of sleep apnea using portable monitoring device. portable monitoring device is applied simultaneously with psg to compare it's accuracy and validity.

Eligibility criteria:
inclusion criteria: * patients suspected of sleep apnea exclusion criteria: * patient refuse to participate
a phase 2, safety, tolerability, and efficacy study of pd 0360324 in chronic pulmonary sarcoidosis

Conditions: Pulmonary Sarcoidosis

Summary: the study proposes to evaluate the safety, tolerability, and efficacy of pd 0360324 in subjects with chronic pulmonary sarcoidosis inadequately treated with standard of care therapies.

the trial was terminated prematurely on mar 24, 2014 due to a business decision. the decision to terminate the trial was not based on any clinical safety or efficacy concerns.

Eligibility criteria:
inclusion criteria: * diagnosis of biopsy-proved chronic pulmonary sarcoidosis either stage 2 or stage 3 for at least 1 year; * forced vital capacity (fvc) lung assessment of \>40% and \< or = to 80% predicted normal values at screening; * age 21-75 years of age; * treatment with a stable (longer than 4 weeks) regimen of corticosteroids (between 10 and 30 mg of prednisone) for at least 3 months prior to screening; (other anti-inflammatory drugs may be permitted as defined by the study protocol) exclusion criteria: * history of any other pulmonary (lung) disease than sarcoidosis (ex, asthma requiring maintenance treatment, chronic obstructive pulmonary disease (copd)); * pulmonary hypertension, significant lung fibrosis, any chronic infection (eg, tb, hiv); * treatment with other biologic anti-inflammatory/immuno-modulatory drugs; * active smokers; * class 3 or 4 congestive heart failure; * cancer, or history of cancer within past 5 years; * history of ischemic heart disease, heart attack, stroke, any heart muscle disease; * liver disease; * history of alcohol or drug abuse

Keywords: phase 2 randomized double blind placebo controlled parallel 20 week safety tolerability and efficacy study
the study of ocular hemodynamics with glaucoma progression

Conditions: Glaucoma

Summary: to determine the relationships between ocular hemodynamics and glaucomatous optic neuropathy progression.

1. to determine whether baseline ocular blood flow values are predictive of glaucomatous progression as determined by visual field analysis. 2. to determine how changes in ocular blood flow are related to visual field progression. 3. to determine how changes in ocular blood flow are related to changes in optic nerve structure and topographic change over time.

Eligibility criteria:
inclusion criteria: patients will meet all of the following inclusion criteria to enter the study: 1. age: 30 years or older. 2. diagnosis: confirmed open-angle glaucoma in at least one eye: 1. glaucomatous visual field loss on humphrey 24-2 or 10-2 perimetry 2. glaucomatous optic disc cupping 3. agreement between two baseline exams for reliability 3. best corrected visual acuity at least 20/60 in at least one eye. 4. prior humphrey visual fields demonstrate acceptable reliability standards (see below). exclusion criteria: 1. extensive humphrey visual field damage consisting of either a mean deviation (md) \< -15 decibels or a clinically determined threat to fixation in both hemifields. 2. evidence of exfoliation or pigment dispersion. 3. history of acute angle-closure or a narrow, occludable anterior chamber angle by gonioscopy. 4. history of chronic or recurrent inflammatory eye diseases (e.g., scleritis, uveitis). 5. history or signs of intraocular trauma. 6. severe or potentially progressive retinal disease such as retinal degeneration, diabetic retinopathy, and retinal detachment. 7. any abnormality preventing reliable applanation tonometry. 8. current use of any ophthalmic or systemic steroid which may interfere with this investigation. 9. cataract surgery within the past year. 10. resting pulse \< 50 beats per minute. 11. severe, unstable or uncontrolled cardiovascular, renal, or pulmonary disease.

Keywords: glaucoma blood flow progression
einstein junior phase ii: oral rivaroxaban in young children with venous thrombosis

Conditions: Venous Thromboembolism

Summary: the purpose of this study is to find out whether rivaroxaban is safe to use in children and how long it stays in the body. safety will be assessed by looking at the incidence and types of bleeding events. there will also be a check for worsening of blood clots.


Eligibility criteria:
inclusion criteria: * children aged 6 months to \< 6 years who have been treated for at least 2 months or, in case of catheter related thrombosis, for at least 6 weeks with lmwh (low molecular weight heparin), fondaparinux and/or vka (vitamin k antagonist) for documented symptomatic or asymptomatic venous thrombosis - hemoglobin, platelets, creatinine, alanine aminotransferase (alt) and bilirubin evaluated within 10 days prior to randomization * informed consent provided exclusion criteria: * active bleeding or high risk for bleeding contraindicating anticoagulant therapy * symptomatic progression of venous thrombosis during preceding anticoagulant treatment * planned invasive procedures, including lumbar puncture and removal of non peripherally placed central lines during study treatment * an estimated glomerular filtration rate (egfr) \< 30 ml/min/1.73 m\^2 * hepatic disease which is associated with either: coagulopathy leading to a clinically relevant bleeding risk, or alt\> 5x upper level of normal (uln) or total bilirubin \> 2x uln with direct bilirubin \> 20% of the total * platelet count \< 50 x 10\*9/l * hypertension defined as \> 95th age percentile * life expectancy \< 3 months * concomitant use of strong inhibitors of both cytochrome p450 isoenzyme 3a4 (cyp3a4) and p-glycoprotein (p-gp), i.e. all human immunodeficiency virus protease inhibitors and the following azole antimycotics agents: ketoconazole, itraconazole, voriconazole, posaconazole, if used systemically * concomitant use of strong inducers of cyp3a4, i.e. rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine * hypersensitivity or any other contraindication listed in the local labeling for the comparator treatment or experimental treatment * inability to cooperate with the study procedures * previous randomization to this study * participation in a study with an investigational drug or medical device within 30 days prior to randomization

Keywords: pediatric
effects of oral salmon calcitonin in human osteoarthritis

Conditions: Osteoarthritis

Summary: to assess the safety, tolerability and clinical efficacy of oral salmon calcitonin in patients suffering from osteoarthritis

osteoarthritis (oa) is a difficult condition to manage and, thus far, we have no simple, effective interventions for this common cause of pain and disability. because parenteral salmon calcitonin (sct) has positive effects in canine experimental oa, this phase iia, randomized,placebo-controlled, double-blind trial evaluates the safety, tolerance and clinical efficacy of an oral formulation of sct in patients with oa. patients receive a tablet containing either a placebo, 0.5 mg sct or 1 mg sct that they have to take every day in the morning 15 minutes before breakfast for 3 months.

Eligibility criteria:
inclusion criteria: * radiographic oa according to the criteria of the american college of rheumatology; * morning joint stiffness between 15 and 30 minutes; * pain on weight bearing and motion reported greater than 40 mm on a 0-100 mm visual analogue scale; * normal liver and kidney function tests; * serum crp levels \< 10 mg/l exclusion criteria: * previous or ongoing treatment with anti-resorptive drugs such as bisphosphonates, estrogen or raloxifene * crystal deposition diseases * known hereditary or congenital defects * clinically significant hepatic, renal, cardiovascular, psychiatric, endocrine and/or hematological diseases * intra-articular injections of either corticosteroids (previous 3 months) or hyaluronan (previous 6 months)

Keywords: lequesne's algo-functional score biomarkers of joint metabolism
phase i/ii clinical study of decitabine combined with tqb2450 injection or decitabine + anlotinib combined with tqb2450 injection in the treatment of pd-1 monoclonal antibody-resistant digestive system tumors

Conditions: Patients With Digestive System Tumors Resistant to PD-1 Inhibitors

Summary: this clinical study focused on patients with digestive system tumors resistant to pd-1 inhibitors, and explored the reversal resistance of epigenetic drugs (decitabine) and tki drugs (anlotinib) in this part of patients.


Eligibility criteria:
inclusion criteria: * voluntary participation and written informed consent; * age: 18-70 years old; * no gender limitation; * digestive system malignant tumor diagnosed by pathology; * previously received pd-1 monoclonal antibody or the combination therapy fails; * there is at least one measurable lesion (according to the recist1.1 standard) or an unmeasurable lesion that can be evaluated, and the imaging diagnosis is ≤21 days from the selection time； * the expected survival period is ≥3 months; * general physical status (ecog) 0-1; * sufficient bone marrow hematopoietic function (within 7 days); normal liver and kidney function (within 14 days)； * heart, lung, kidney, and liver functions are generally normal. exclusion criteria: * people who are currently receiving other effective treatments; * patients who have been treated with anti-vascular tki drugs in the past; * patients who have participated in other clinical trials within 4 weeks before enrollment; * allergic to study drugs; * those without measurable tumor lesions, such as body cavity effusion or diffuse infiltration of organs; * those with measurable lesions that have received radiotherapy. * patients with other primary malignant tumors other than digestive system tumors at the same time, except for early solid tumors that have been cured for more than 1 year; * clinically significant cardiovascular diseases, such as heart failure (nyhaiii-iv), are not controlled a history of coronary heart disease, cardiomyopathy, arrhythmia, uncontrolled hypertension or myocardial infarction within the past 1 year; * neurological or mental disorders that affect cognitive ability, including central nervous system metastasis; * existed within 14 days before enrollment active severe clinical infections (\>grade 2 nci-ctcae version 5.0), including active tuberculosis; * known or self-reported hiv infection or active hepatitis b or c; * uncontrolled systemic diseases, such as poorly controlled diabetes; * a history of interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or evidence of interstitial lung disease on baseline chest x-ray/ct; * keratitis , ulcerative keratitis or severe dry eye; * known hypersensitivity or allergic reaction to any component of the study drug; * pregnancy (determined by serum β-chorionic gonadotropin test) or breast-feeding.
study of acalabrutinib alone or in combination therapy in subjects with b-cell non-hodgkin lymphoma

Conditions: Non Hodgkin Lymphoma

Summary: part 1: to characterize the safety profile of acalabrutinib alone or in combination with rituximab in subjects with r/r fl. part 2: to characterize the activity of acalabrutinib alone or in combination with rituximab in subjects with r/r mzl, as measured by orr. part 3: to characterize the safety of acalabrutinib in combination with rituximab and lenalidomide in subjects with r/r fl

an open-label, phase 1b/2 study of acalabrutinib alone or in combination therapy in subjects with b-cell non-hodgkin lymphoma

Eligibility criteria:
inclusion criteria: * men and women ≥ 18 years of age. * part 1: a confirmed diagnosis of fl grade 1, 2, or 3a, which has relapsed after, or been refractory to ≥ 1 prior therapy for fl, or subjects who have not previously received systemic anticancer therapy for fl., and which requires treatment. * part 2: for subject with relapsed or refractory mzl: histologically confirmed mzl including splenic, nodal, and extranodal sub-types 1. subjects with splenic mzl must have an additional measurable lesion, nodal or extranodal, as described in inclusion criterion #4; 2. subjects with gastric mucosa-associated lymphoid tissue (malt) lymphoma must be helicobacter pylori (hp)-negative * part 3: for subjects with fl: pathologically confirmed diagnosis of fl grade 1, 2, or 3a, which has relapsed after, or been refractory to ≥ 1 prior therapy for fl and which requires treatment per national cancer institute or esmo clinical practice guidelines. * eastern cooperative oncology group (ecog) performance status of ≤ 2. * agreement to use contraception during the study and for 30 days after the last dose of study drugs if sexually active and able to bear or beget children. exclusion criteria: * •a life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of acalabrutinib, or put the study outcomes at undue risk * significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 or 4 cardiac disease as defined by the new york heart association functional classification, or qtc \>480 msec * malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, gastric bypass, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction. * breast feeding or pregnant

Keywords: bruton tyrosine kinase inhibitor btk follicular lymphoma fl acalabrutinib acp-196 mzl marginal zone lymphoma
trade trial - tree nut immunotherapy route development and evaluation

Conditions: Tree Nut Allergy; Food Allergy

Summary: tree nut immunotherapy route assessment and development (trade) is a randomized controlled trial that evaluates the efficacy and safety of sublingual immunotherapy and lower, more tolerable, doses of oral immunotherapy than currently in use.


Eligibility criteria:
inclusion criteria: * allergic to tree nut with baseline threshold of 444 mg protein or less and provides consent, and where applicable, assent. exclusion criteria: 1. history of anaphylaxis to tree nut severe enough to cause shock, syncope, or intubation 2. eosinophilic or other inflammatory gastrointestinal disease within the past 2 years 3. severe (gina severity class 5) or uncontrolled asthma including exacerbation within past 6 months 4. use of biologics, other food immunotherapy or experimental treatment in past 6 months. 5. ongoing other allergic diseases severe enough to preclude discontinuing antihistamines for 7 days prior to assessment visits 6. pregnancy or significant medical condition (e.g., liver, kidney, gastrointestinal, cardiovascular, hematologic, or pulmonary disease; allergy to the oat-based placebo) which would put the participant at excessive risk for food allergic reactions as judged by local investigator

Keywords: immunotherapy randomized controlled trial (rct)
long-term follow-up study of livercellgram in alcoholic lc patients who completed livercellgram phase 2 study

Conditions: Alcoholic Liver Cirrhosis

Summary: this is a 5-year (+30 days) long term follow up study to evaluate the safety of livercellgram in subject who participated in and completed the livercellgram phase 2 trials (refer to clinicaltrials.gov.identifier: nct01875081).

this is a 5-year (+30 days) long term follow up study to evaluate the safety of livercellgram in subject who participated in and completed the livercellgram phase 2 trials (refer to clinicaltrials.gov.identifier: nct01875081). this trial is planned to evaluate the safety of livercellgram in patients with alcoholic liver cirrhosis. subjects who signed this follow-up observation informed consent form will participate in a safety assessment (tumor marker test, occurrence of adverse events and serious adverse events, clinical laboratory tests, vital sign, physical examinations.).

Eligibility criteria:
inclusion criteria: 1. subjects who treated with livercellgram and completed the livercellgram phase 2 study. 2. subjects who can agree to participate in the long term observation study by oneself. exclusion criteria: * not applicable
hydrocodone/acetaminophen for acute pain following third molar tooth extraction

Conditions: Pain

Summary: the purpose of this study was to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen compared to placebo in moderate to severe pain following molar extraction.

dosing started within 6 hours after completion of third molar extraction. study drug was given once every 6 hours for 12 hours (for a total of 2 doses). participants were randomized to receive placebo or active drug (either experimental drug or comparator). the total dose was the same for both groups receiving active drug, but was given as either 1 dose of extended-release tablets (experimental drug), or 2 doses of immediate-release tablets (active comparator).

Eligibility criteria:
inclusion criteria: * subjects who are in general good health, experiencing moderate to severe pain after surgical extraction of 2 or more third molars and who are willing to remain confined until the morning after surgery for study procedures exclusion criteria: * allergies to study medications * history of multiple drug allergies * unable to stop excluded medications * clinically significant laboratory abnormalities at screening * significant medical condition at screening * women who are pregnant or breast feeding