Kornimate/medical-research-clean huggingface dataset:
efficacy, safety and tolerability of pf-06649751 in parkinson's disease patients at early stage of the disease

Conditions: Parkinson Disease

Summary: the purpose of this study is to evaluate the efficacy, safety and tolerability of pf-06649751 in parkinson's disease patients at early stage of the disease.

the b7601011 study has a randomized, double-blind, placebo-controlled parallel group design. approximately 88 subjects will be randomized to 2 treatment groups. each subject will participate in the study for approximately 23 weeks including a 30 day screening period, 15 week double blind treatment period, and an approximately 28 day follow-up period.

Eligibility criteria:
inclusion criteria: * females of non-childbearing potential and/or male subjects * clinical diagnosis of parkinson's disease. * parkinson's disease hoehn \& yahr stage i-iii inclusive * treatment naïve or history of prior incidental treatment with dopaminergic agents for no more than 28 days * able to refrain from any parkinson's disease medication not permitted by the protocol. exclusion criteria: * history or presence of atypical parkinsonian syndrome. * severe acute or chronic medical or psychiatric condition or cognitive impairment or laboratory abnormality. * any condition possibly affecting drug absorption. * participation in other studies involving investigational drug(s), or treatment with any investigational drug within 30 days.

Keywords: early parkinson disease phase 2
china kidney patient trials network

Conditions: Kidney Diseases

Summary: this is a prospective multi-centre, observational cohort study of incident and prevalent patients diagnosed with a kidney disease in china.


Eligibility criteria:
inclusion criteria: 1. documented diagnosis of primary kidney disease 2. regular visits (at least 6 monthly) with a physician at a participating site 3. egfr \> 15 ml/min/1.73 m2 4. ≥ 2 years of age 5. willing and able to sign informed consent 6. willing to be approached about participation in interventional research studies exclusion criteria: * 1. life-expectancy of less than 6 months

Keywords: chronic kidney disease diabetic nephropathy hypertensive kidney disease glomerulonephritis gn focal segmental glomerulosclerosis fsgs membranous nephropathy minimal change disease iga nephropathy glomerulonephritis not otherwise specified
efficacy and safety of tak-438 for the prevention of recurrent gastric or duodenal ulcers during therapy of non-steroidal anti-inflammatory drug (nsaid)

Conditions: Gastric Ulcers; Duodenal Ulcers

Summary: the purpose of this study is to evaluate the efficacy of tak-438, once daily (qd), compared to ag-1749 (lansoprazole) in patients with a history of gastric or duodenal ulcer who require long-term therapy of non-steroidal anti-inflammatory drug (nsaid).


Eligibility criteria:
inclusion criteria: 1. participants who require continuous nsaid therapy during the treatment period with the study drug 2. participants who have a history of ulcer in stomach or duodenum, endoscopically confirmed 3. outpatient (including inpatient for examinations) exclusion criteria: 1. participants scheduled to change the type and dosage regimen of nsaid 2. participants with ulcers or bleeding in stomach or duodenum, endoscopically confirmed 3. participants with small intestine bleeding, large intestine bleeding, or gastrointestinal bleeding of unknown etiology 4. participants who have a history of surgery which affects gastric acid secretion (e.g., resection of upper gastrointestinal tract, vagotomy) or who are scheduled to undergo such surgery 5. participants with a previous or current history of zollinger-ellison syndrome, or other gastric acid hypersecretion disorders 6. participants with a previous or current history of aspirin-induced asthma

Keywords: drug therapy
prevention management model for early childhood caries (maya project)

Conditions: Dental Caries

Summary: the purpose of this study is to determine whether dental disease patterns and transmissable bacteria that are known to cause a severe form of dental decay in young children can be reduced or eliminated by treating mothers and their young infants early on with chlorhexidine and fluoride varnish applications, respectively as part of a comprehensive prevention management model.

the primary aim is to evaluate two programs, a minimal intervention program and a moderate intensity program, for preventing early childhood caries. a four-year randomized clinical trial will be conducted specifically to: 1) assess demographic and behavioral factors as predictors of ecc and the relationship between three-year post-intervention behavioral changes from baseline measures with disease outcomes; 2) compare the efficacy for the prevention of ecc in two groups - the minimal intervention group (group 1) receiving counseling alone, with the moderate intensity group (group 2) receiving a) counseling and a therapeutic four-month regimen of chlorhexidine rinse for new mothers and b) fluoride varnish applications for their infants and toddlers starting at twelve months of age and continuing to age 30 months; 3) assess baseline salivary microbiological markers as predictors of ecc in the infants of women in both groups and the relationship between three-year post-intervention salivary markers and changes from baseline measures with disease outcomes; 4) assess the impact of a caries-preventive model in lowering the salivary mutans streptococci level in post-partum women, and subsequently, in inhibiting the growth of these bacteria in their young children, delaying the infectious process. the long term objectives are to build upon our understanding of caries risk factors, to assess the effectiveness of a prevention management model, to improve access to preventive oral health services and information for low-income pregnant women and their young children, and to reduce oral health disparities in a border population (u.s. - mexico border near san diego bay area) at high risk for dental disease.

Eligibility criteria:
"inclusion criteria" * some evidence of geographic stability in south san diego bay area * planning on remaining in area approximately 3 years after birth of child * must be able to provide consent in english or spanish * must be registered patients at san ysidro health center in the prenatal program * must be experiencing a normal pregnancy "exclusion criteria" * diabetes, anemia, placenta previa, seizure disorders, gdm, evidence of chromosomal disorders, polyhydramnios, thrombophlebitis, or rh-negative status * vaginal bleeding, premature uterine contractions, viral or bacterial infections, diabetes, pregnant with twins or multiple births expected * previous pregnancy complications where hospitalization was required

Keywords: early childhood caries
a trial of shr-1314 injection in adult patients with active non-radiographic axial spondyloarthritis

Conditions: Active Non-radiographic Axial Spondyloarthritis

Summary: the study is being conducted to evaluate the efficacy and safety of shr-1314 injection in adult patients with active non-radiographic axial spondyloarthritis.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years at the time of signing the informed consent form, regardless of gender. 2. bmi (body mass index) ≥ 18 kg/m² at the time of screening. 3. presence of objective signs of inflammation at the time of screening. 4. the subject voluntarily signs the icf (informed consent form) before the start of any study-related procedures. 5. the subject is able to communicate effectively with the investigator, understands and is willing to strictly adhere to the requirements of the clinical study protocol to complete the study. exclusion criteria: 1. subjects with active systemic infection or severe infection. 2. subjects with active tuberculosis or latent tuberculosis infection. 3. subjects with lymphoma or lymphoproliferative disease. 4. subjects with uncontrolled hypertension. 5. subjects with history of malignancy within the past 5 years or current malignancy. 6. subjects with moderate to severe congestive heart failure. 7. subjects with history of organ transplantation, or severe, progressive, or uncontrolled diseases of any organ system. 8. presence of protocol-defined abnormalities in laboratory tests and/or 12-lead ecg at the time of screening. 9. pregnant or breastfeeding women. 10. known allergy to the study drug or any of its components. 11. subjects with history of alcohol abuse or illegal drug use within the past year. 12. receipt of a live vaccine within 12 weeks before randomization, or plans to receive a live vaccine during the study period. 13. blood donation of approximately 500 ml within 8 weeks before randomization, or plans to donate blood during the study period.
resistant starch, epigallocatechin gallate and chlorogenic acid for body weight loss in menopause

Conditions: Overweight

Summary: for women aged between 55 and 65 years weight gain is a major health concern. obesity is an important risk factor for multiple diseases (e.g. metabolic syndrome, diabetes mellitus, hypertension and cardiovascular disease), and several studies have shown that the transition to menopause is associated with adverse changes in body composition. in particular, it is common to observe the accumulation of adipose tissue in the abdominal region which is believed to be an important determinant of the increase in cardiovascular risk. the first-line strategy for weight management in overweight / obese subjects is the modification of dietary habits and lifestyle in terms of physical activity. however, nowadays, there is also a growing interest in complementary therapies (i.e. herbal supplements, acupuncture, etc ...) that can be used alone or in combination to achieve more consistent results. in this context, preliminary evidence supports the potential role of some compounds of vegetal origin such as resistant starch, epigallocatechin gallate and chlorogenic acid as adjuvants of dietary therapy for overweight. these nutrients may be an important therapeutic aid for overweight subjects. however, in support of their use, the evidence from good quality trials is limited.


Eligibility criteria:
inclusion criteria: * menopause of recent onset * overweight (body mass index ≥ 25) or weight gain ≥ 10% after menopause * written informed consent exclusion criteria: * use of orlistat * cancer diagnosis * unavailability to planned measurements
the safety, tolerability, pharmacokinetics and pharmacodynamics of js207 in patients with advanced malignant tumor

Conditions: Advanced Malignant Tumor

Summary: this is a phase i open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (pk),pharmacodynamic characteristics, immunogenicity and antitumor activity of js207 in patients with advanced malignant tumor. the recommended dose for phase ii trial （rp2d） will be determined based on the safety, tolerability, pharmacokinetics.


Eligibility criteria:
inclusion criteria: 1. patients with advanced malignant tumor confirmed by histology or pathology, failed by standard treatment, no standard treatment or no standard treatment is applicable; 2. eastern cooperative oncology group (ecog) 0 or 1; 3. life expectancy ≥ 12 weeks; 4. at least one measurable lesion according to recist 1.1; 5. adequate organ function; exclusion criteria: 1. central nervous system metastasis； 2. there is a pleural, abdominal or pericardial effusion that is clinically symptomatic or requires repeated management (puncture or drainage, etc.)； 3. images in screening showed that the tumor surrounded important blood vessels or had obvious necrosis and voids, and the investigators believed that it might cause bleeding risk； 4. the presence of severe, unhealed or open wounds, active ulcers, or untreated fractures； 5. a history of significant bleeding tendency or severe coagulopathy； 6. the presence of poorly controlled hypertension；
university hospital advanced age pregnant cohort

Conditions: Advanced Maternal Age Pregnancy; High Risk Pregnancy; Perinatal Death; Maternal Death; Various Pregnancy Complications; Stillbirth and Fetal Death; Abortion, Spontaneous

Summary: the university hospital advanced age pregnant (unihope) cohort is the major part of the national key research and development program on reproductive health \& major birth defects control and prevention project, which is funded by the ministry of science and technology of china. the project is led by prof. zhao yangyu, from the department of gynecology \& obstetrics, peking university third hospital, and the unihope cohort is led by prof. jian-meng liu, the co-pi of the project.

the unihope cohort is set up to provide comprehensive evidence for the prevention and treatment of gestational complications in pregnant women with advanced maternal age, and therefore, to meet the growing clinical challenges of increasing pregnant women with advanced age in the two-child era. the unihope cohort is planning to recruit 22,000 pregnant women aged ≥35 years from 9 large obstetrical center of major university-affiliated hospitals across china, between july 2016 and december 2020. all women will be enrolled prior to 14 wks of gestation, followed up at 24-28 wks, 32-34 wks of gestation, delivery, and 42 days postpartum. data including demographics, medical history, reproductive history, prenatal health care, gestational complications, and pregnancy and birth outcomes will be collected via electronic data capture system. venous blood of the pregnant women will be collected at enrollment and each follow-up visit during pregnancy, and placental tissue, cord blood and hair of the newborn will also be collected.

Eligibility criteria:
inclusion criteria: * female aged ≥ 35 years * less than 14 gestational weeks * planning to receive prenatal healthcare and delivery service at the study hospital exclusion criteria: * inability to provide informed consent * women with mental disorders
base curves of bandage contact lenses and their effects on post trans-prk vision and pain

Conditions: Myopia

Summary: the objective of this study was to investigate the impact of employing bandage contact lenses with a base curve of 8.4 mm versus 8.8 mm on visual recovery following trans-prk in patients characterized by steep corneas and high myopia.

comparing two kind of bandage lenses in the contralateral eyes of the same individual following trans-prk may enable the derivation of reliable conclusions regarding the optimal choice for bandage lenses after trans-prk.

Eligibility criteria:
inclusion criteria: spherical equivalent refractive error between -6.00 and -8.00 d in either eye. astigmatism of no more than 2.0 d in either eye. best spectacle-corrected visual acuity (bcva) according to the logarithm of the minimum angle of resolution (logmar) scale of 0 or better in both eyes. willing and able to participate in all required activities of the study. exclusion criteria: diabetes mellitus. systemic connective tissue disease. cardiovascular disease, epilepsy. eyelid abnormalities. corneal disease. glaucoma. a history of ocular disease. noncompliance with measurement at enrollment.

Keywords: transepithelial photorefractive keratectomy high myopia bandage contact lenses
intervention on new onset-t1d children

Conditions: Type 1 Diabetes

Summary: a pilot proof of concept clinical trial will be performed to demonstrate the restoration of gut barrier integrity by administration of beneficial anti-inflammatory gut microbial strains (lactobacilli-enriched vivomixx® probiotic) to new onset type 1 diabetes children.

this is an interventional randomized, 2-arm, single-blind, single-center, placebo-controlled mechanistic clinical trial (1:1). one sachet of probiotic for children \ 10 years old dissolved into water or noncarbonated drinks will be administered every day for 90 consecutive days.the primary end point of the study will be the preservation of the residual insulin-producing beta-cell mass measured as the change in c-peptide values at 12 months after the beginning of treatment. moreover, the investigators will collect blood samples for serological analysis (autoantibodies detection, measurement of biomarkers of gut barrier integrity) and immunological profiling; fecal samples for microbiome and metabolomic analysis. finally the investigators will assess whether the response to vivomixx® probiotic remains stable over a long-term period, that is in the absence of active treatment.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of insulin-dependent type 1 diabetes * positive for at least one islet autoantibody (ica, gada, ia-2, iaa, znt8) * no more than 3 months from first insulin injection * ≥ 7 to \< 18 year old exclusion criteria: * diagnosed with celiac disease, ibd or other intestinal inflammatory pathologies * diagnosed with tuberculosis, hepatitis b or c, hiv, or active ebv or cmv infection; significant cardiac disease; conditions associated with immune dysfunction or hematologic dyscrasia (including malignancy, lymphopenia, thrombocytopenia, or anemia); liver or renal dysfunction. * ongoing use of systemic medications other than insulin. * recent administration of antibiotics (1 months prior to treatment) * deemed unlikely or unable to comply with the protocol or have any complicating medical issues or abnormal clinical laboratory results that interfere with study conduct or cause increased risk.

Keywords: gut microbiome intestinal barrier integrity
comparison of anticoagulation for all-comers undergoing percutaneous coronary revascularization trial

Conditions: Percutaneous Coronary Intervention

Summary: the purpose of this trial is to determine whether bivalirudin is non-inferior to unfractionated heparin in patients with stable angina, unstable angina, or non-st segment elevation myocardial infarction undergoing percutaneous coronary intervention.


Eligibility criteria:
inclusion criteria: 1. undergoing pci for stable angina, unstable angina, or non-st segment elevation myocardial infarction. 2. age 18 years or older. exclusion criteria: 1. inability to obtain consent 2. emergency cardiac catheterization for st-segment elevation myocardial infarction.
reproducibility study of overactive bladder symptom score [oabss]

Conditions: Overactive Bladder

Summary: the purpose of this study is to evaluate its reproducibility of overactive bladder symptom score (oabss) and to evaluate its correlation to other measures of oab symptoms.


Eligibility criteria:
inclusion criteria: * symptoms oab for 3 months or longer * at least 1 urgency episode in last 3 days * symptoms of oab as verified by 3-day micturition diary prior to visit 1, defined by: * number of micturition per day ≥8 * number of urgency episodes in 3 days ≥1 exclusion criteria: * significant stress incontinence or mixed stress/urge incontinence * subjects with indwelling catheters or practicing intermittent self-catheterization * symptomatic urinary tract infection, chronic inflammation * diabetic neuropathy * drug or non-drug treatment for oab was started, quitted or changed in 4 weeks * participation in any clinical trial in 30 days

Keywords: oabss ipss ppbc 3-day micturition diary
novapak nasal packing in shellfish allergic patients

Conditions: Shellfish Hypersensitivity; Epistaxis

Summary: novapak is a sponge-like material made from materials found in shellfish. it is commonly used after nasal surgery or in nasal bleeding, as it promotes healing, decreases bleeding, and has antibacterial properties. although novopak does not contain proteins or compounds known to be responsible for allergic reactions in people with a known allergy to shellfish, out of an abundance of caution, the manufacturer (medtronic) has recommended avoidance in those with known shellfish allergy. there have been no reported allergic reactions in patients with shellfish allergy who were given chitosan bandages in emergencies (e.g. military applications). the study aims to investigate the safety of its use in patients with known shellfish allergy to improve healthcare quality and patient care support.

this is a prospective interventional study to assess whether the tested product triggers an allergic reaction in patients with known-shellfish allergies. the primary objective is to assess the safety of novapak, a chitosan-containing nasal packing material, in patients with known shellfish allergy. the study will be conducted in two phases. first, participants will undergo an allergy test - skin prick test (spt) to crab, lobster, shrimp, oyster, clam, scallop, squid, and octopus -, and antibody levels analysis. second, in a controlled setting (i.e., in a hospital clinic that includes a resuscitation cart and doctors monitoring - allergist and otolaryngologist), novapak packing will be applied to the patient's skin for 30 minutes (on the anterior aspect of the patients' non-dominant arm). then, provided that no allergic symptoms are observed in stage 1, the patient's nose will be anesthetized with topical lidocaine, and a piece of novapak material will be applied to the participant's nasal cavity at the level of the inferior turbinate for 15 minutes. after removal, the participant will be monitored in the clinic for an hour. any allergic reaction will be documented, including increased nasal congestion, rhinorrhea, or pruritis. since novapak contains purified chitosan, the investigators hypothesizes that no allergic reactions will be demonstrated.

Eligibility criteria:
inclusion criteria: * adults aged 18-60 * positive history of shellfish allergy * confirmation of allergy via previous reaction during oral challenge or convincing clinical history and testing. exclusion criteria: * severe lung diseases: severe asthma, obstructive lung disease * severe cardiovascular disease: history of congestive heart failure, myocardial infarction, valvulopathy, or unstable tachy-or-bradyarrhythmia. * severe cerebrovascular disease: history of stroke or severe carotid stenosis. * presence of beta-blocker mediations. * patients unable to discontinue antihistamine medications or prednisone. * patients with severe or refractory anaphylaxis during prior oral challenge to shellfish, or those with documented systemic mastocytosis. * pregnancy

Keywords: nasal bleedings post-surgical healing chitosan-based films
simple suppers scale-up (s3)

Conditions: Childhood Obesity

Summary: the purpose of this study is to determine effectiveness of a family meals intervention, simple suppers, aimed at eliciting positive changes in child dietary intake and weight status.


Eligibility criteria:
inclusion criteria: * caregivers: primary food preparer in the home; responsible for at least one child 4-10 years of age; speak english as the primary language in the home; lived in the u.s. for at least one year. exclusion criteria: * family member: following a restrictive or therapeutic diet.
endometrial gene expression profile in controlled ovarian stimulation cycles with premature luteinization

Conditions: Premature Luteinization

Summary: previous studies have suggested that premature luteinization (pl)during controlled ovarian stimulation (cos) decreases the implantation rate due to a negative effect on the endometrium receptivity. this study aims to describe the impact on endometrial gene expression of pl in gnrh antagonist and gnrh agonist cycles.


Eligibility criteria:
inclusion criteria: * oocyte donors * age between 18-35 years old * bmi 18-29 * normogonadotrophics * progesterone ≥ 1.2 ng/ml on hcg day exclusion criteria: * polycystic ovarian syndrome (pcos) * endometriosis