Kornimate/medical-research-clean huggingface dataset:
study to test the blood to see if a new medicine is likely to provide pain relief similar to a product already sold in stores

Conditions: Pain

Summary: this study is designed to assess bioequivalence between one test and one reference formulation used for temporary relief of pain. the results will help decide if the new medicine is likely to provide pain relief similar to the product being sold.

the study is a single dose, randomized, two-way crossover study in 32 healthy male and female volunteers, minimum of 14 of each gender. two doses of study medication will be given as single doses on two separate treatment visits. a washout of at least 48 hours will separate the treatment visits. each visit will include an overnight fast at the clinic and 19 blood samples drawn for pharmacokinetic analyses. tolerability of the treatments will be evaluated in terms of reported and observed adverse events (ae).

Eligibility criteria:
inclusion criteria: * healthy (per protocol-specified parameters) male or female subjects (14 of each gender) between the ages of 18 and 50 years, inclusive. * non- or ex-tobacco user, being defined as someone who completely stopped smoking or using any form of tobacco for at least 12 months before screening visit of this study. * for females: if not postmenopausal, agrees to use a protocol-specified means of contraception or declared absence of sexual contact with a male partner during the study. * for males: no pregnant spouse or partner at screening and willingness to protect potential spouse or partner from becoming pregnant during the study. * body mass index (bmi) within protocol-specified parameters. * a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. * willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures specified in the protocol. exclusion criteria: * evidence or history of an acute or chronic medical or psychiatric condition, laboratory abnormality, or drug use that, in the judgment of the investigator or an authorized physician, may compromise subject safety or the interpretation of results. * females: pregnant or breast-feeding * treatment with an investigational drug within 3 months preceding the first dose of study treatment. * history of regular alcohol consumption outside the protocol-specified allowances. * donation or loss of blood within 3 months prior to the first treatment visit if the estimated lost blood volume equaled or exceeded 450 ml. * relationship to persons involved directly with the conduct of the study, or their families.

Keywords: pharmacokinetics
a study of the relative bioavailability of single dose ro4917838 and the effect of food in healthy volunteers

Conditions: Healthy Volunteer

Summary: this single center, randomized, single dose, open-label, four period cross-over study will evaluate the relative bioavailability of ro4917838 and the effect of food following oral administration in healthy volunteers. subjects will receive in randomized order single oral doses of ro4917838 film coated tablets, either in the fasted or fed condition, or ro4917838 hard gelatin capsules or ro4917838 oral suspension, with a washout period of at least 21 days between treatments. anticipated time on study will be up to 23 weeks.


Eligibility criteria:
inclusion criteria: * healthy male and female volunteers, 18 to 65 years of age, inclusive * body mass index (bmi) 18 to 30 kg/m2 inclusive * healthy as determined by the investigator on the basis of medical and surgical history and a complete physical examination * non-smoker or smoker of fewer than 10 cigarettes per day; subject must be able to refrain from smoking during the in-patient stays * females who are not postmenopausal or surgically sterile must agree to use two adequate methods of contraception as defined by protocol during the treatment period and for at least one month after the last dose of study drug exclusion criteria: * any condition or disease detected during the medical interview/physical examination that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the investigator * history of alcoholism, drug abuse and/or drug addiction within the last year prior to period 1. day -1 of the study * history of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic, psychiatric disease, or cancer * any history of depressive episodes or treatment with antidepressants * any significant allergic reactions against any drug, or multiple allergies in the judgement of the investigator * pregnant or lactating females * positive for hepatitis b, hepatitis c or hiv infection * participation in another investigational study of any type within 90 days of ro4917838 administration or within 6 times the elimination half-life of the tested drug, whichever is longer
evolution® biliary stent system-fully covered

Conditions: Carcinomas/Neoplasms

Summary: the evolution® biliary stent system-fully covered study is a clinical trial approved by the us fda to evaluate the effectiveness of the evolution® biliary stent system-fully covered when used in palliation of malignant neoplasms in the biliary tree.


Eligibility criteria:
inclusion criteria: * inoperable malignant neoplasm causing biliary obstruction or stricture that requires a fully covered metal stent exclusion criteria: * \< 18 years of age * unwilling or unable to sign and date the informed consent * unwilling or unable to comply with the follow-up schedule * undergone or is planning to undergo brachytherapy with transpapillary or percutaneous implantation of intracavitary radiation sources * participating in another investigational drug or device study in which patient has not completed the follow-up phase for the primary endpoint at least 30 days prior to enrollment * endoscopic procedures are contraindicated * current anatomy upstream of intended stent placement compromising the flow of bile from the liver such that stent placement may not alleviate the biliary obstruction symptoms * presence of a metal biliary stent * presence of an esophageal or duodenal stent * hypersensitivity/allergy or contraindication to any component of the stent, delivery system, or medication required to complete the procedure,which in the investigator's opinion cannot be adequately premedicated * coagulopathy * diffuse intrahepatic metastases that involves \> 10 % of the liver * life expectancy of \< 3 months * pregnant * active alcohol or substance abuse issue * jaundice secondary to a cause other than biliary duct obstruction * additional endoscopic restrictions as specified in the clinical investigation plan

Keywords: bile duct obstructions biliary stases biliary tract stents
optimization of a decision formula for optimal timing of immunosuppressive therapy initiation in primary membranous nephropathy: a multicenter retrospective cohort study

Conditions: Primary Membranous Nephropathy

Summary: the goal of this observational study is to optimize the evaluation formula for the timing of initiating immunosuppressive therapy in primary membranous nephropathy in patients with primary membranous nephropathy. the main question it aims to answer is:when should immunosuppressive therapy be initiated?this study is a retrospective one. participants will not receive any treatment.


Eligibility criteria:
inclusion criteria: * it meets one of the diagnostic criteria for pmn as stipulated in the kdigo 2021 clinical practice guidelines for the management of glomerular diseases: patients with a clear diagnosis of pmn based on renal biopsy pathology or presenting with nephrotic syndrome and positive anti-pla2r antibody detection (\>14ru/ml), and excluding secondary factors such as tumors, infections, drugs, and systemic autoimmune diseases. exclusion criteria: * (1) patients who have received treatment with immunosuppressive medications other than oral prednisolone. (2) the time interval between the renal biopsy and the baseline measurement is longer than 3 years. (3) initiate the use of immunosuppressive agents within 1 week after the diagnosis of pmn. (4) participate in the immunosuppressive treatment trial during the follow-up period and be in the intervention group.

Keywords: primary membranous nephropathy evaluation formula initiate immunosuppressive therapy
human umbilical cord blood infusion in patients with acute ischemic stroke (ais)

Conditions: Acute Ischemic Stroke

Summary: a phase ii, randomized, double-blind, parallel, placebo-controlled study to assess the safety and efficacy of human umbilical cord blood infusion in patients with acute ischemic stroke

this is a phase ii study to evaluate the safety and efficacy in hucb treatment on the patients with acute ischemic stroke (ais).

Eligibility criteria:
inclusion criteria: * male or female subject ≥18 and ≤80 years of age. * subject with a confirmed diagnosis of ais and hemiplegia exclusion criteria: * subject with known immune disease, immunodeficiency, or receives immunosuppressive therapy/immunomodulators within 4 weeks or 5 half-lives prior to screening, whichever is longer.
the effectiveness of adhesive versus conventional nasoalveolar molding on children with unilateral cleft lip and palate

Conditions: Cleft Lip and Palate

Summary: the present study will compare the effectiveness of adhesive nasoalveolar molding (gs-nam) and conventional nasoalveolar molding on the alveolar ridge, nasal, and labial growth in children with unilateral cleft lip and palate. objectives: - 1. evaluation of the anatomical position of the greater and lesser segments of the maxilla related to a stable midline anatomical point. 2. evaluation of the nasal symmetry.

cleft lip and palate can manifest as an independent anomaly, be associated with a syndrome, or present as a complex condition. unilateral clefts are notably more common, occurring nine times more frequently than bilateral clefts. additionally, it predominantly affects males, with a male-to-female ratio of 2:1. common clinical features in unilateral cleft lip and palate cases involve structural changes in the nose, lip, palate, and alveolar arch. peri-oral tissues lack continuity, and on the affected side of the nose, you can observe wider nostrils and a downward-pointing alar rim. additionally, the columella and nasal tip shift towards the unaffected or normal side, accompanied by the displacement of the maxillary alveolar segments towards the lateral side. conventional treatment for cleft lip and palate historically comprised numerous surgical procedures, including secondary revisions and alveolar bone grafting. however, even with these multiple interventions, concerns persisted regarding suboptimal aesthetics. therefore, the pursuit of non-surgical treatment options that can mitigate the severity of this deformity during early life is greatly desirable. the introduction of the presurgical nasoalveolar molding (nam) procedure has offered an alternative, allowing for the avoidance of traditional secondary surgeries while achieving improved outcomes. . these interventions should be initiated within the narrow time frame from birth to four months, as estrogen levels decrease within the first four months after birth, making this period optimal for tissue manipulation.

Eligibility criteria:
inclusion criteria: * age: 1- 8 weeks. * gender: male and female. * patients with a unilateral cleft alveolus and lip. * no developmental syndromes or atypical cleft pathology in medical history. * no previous history of unilateral clp correction. * motivated parents toward the treatment. exclusion criteria: * patients with a bilateral cleft alveolus and lip * syndromic patient * uncooperative caregiver
prospective feasibility study evaluating echomark lp placement and echosure measurements for subjects requiring arteriovenous fistulae

Conditions: Kidney Diseases; Arteriovenous Fistula

Summary: multi-center trial to assess the feasibility and safety of the echomark lp and the echomark diagnostic ultrasound system for assessing av fistula blood flow, diameter, and depth.

this is a prospective, multi-center, single-arm, non-blinded clinical trial designed to evaluate the feasibility and safety of the echomark and the echosure in subjects undergoing new upper arm autologous arteriovenous fistula creation who require hemodialysis. all subjects will provide informed consent prior to undergoing any study procedures. the study will consists of multiple follow-up visits during the 52 week duration. subjects are able to re-consent and remain in follow-up for an additional year.

Eligibility criteria:
inclusion criteria: 1. males or non-pregnant, non-breastfeeding females ≥ 18 years of age but \< 85 years of age at the time of informed consent 2. subject is able and willing to provide written informed consent prior to receiving any non-standard of care, protocol specific procedures 3. subject is willing and capable of complying with all required follow-up visits 4. subject and/or care team agree that the distance and transportation resources from the subject's home to the clinic are reasonable for study participation and compliance 5. subject has an estimated life expectancy \> 18 months 6. subject is ambulatory (cane or walker are acceptable) 7. subjects presenting for upper arm autologous arteriovenous fistula creation 8. vein diameter \> 2.5 mm at the antecubital fossa via imaging 9. artery diameter \> 3 mm via imaging 10. subject is not participating in another investigational clinical trial that has not met its primary endpoint. participation in a post-market registry is acceptable. exclusion criteria: 1. subjects receiving a forearm fistula. 2. subject has history of steal syndrome. 3. subject who is immunocompromised or immunosuppressed. 4. subject has had three previous failed av fistulae for hemodialysis access 5. subjects expecting to undergo major surgery within 60 days from the echomark implantation. 6. known or suspected active infection on the day of the index procedure. 7. subjects who had infection(s) in the 30-day window prior to echomark placement to reduce the likelihood of partially treated infections that can seed the device and fistula 8. subjects with diagnosed bleeding disorder, thrombocytopenia (platelet count \<50,000), hypercoagulability, and history of recurrent deep vein thrombosis not related to av access 9. subjects with active malignancy 10. subjects with a history of poor compliance with the dialysis protocol 11. subjects with a known or suspected allergy to any of the device materials 12. subjects with an existing fistula or graft 13. subjects who are pregnant, plan to become pregnant, or are breastfeeding.
covered versus uncovered self-expandable metallic stents for malignant gastric outlet obstruction

Conditions: Gastric Outlet Obstruction Due to Gastric Adenocarcinoma

Summary: malignant gastric outlet obstruction can result from gastric adenocarcinoma, leading to intractable vomiting, nausea, and poor oral food intake. although self-expandable metallic stent (sems) insertion has excellent technical and clinical success rates for relieving gastric outlet obstruction symptoms, the uncovered sems is susceptible to re-stenosis because of tumor ingrowth through openings between the stent wire filaments. therefore, the most common reason for stent failure in uncovered stents is tumor ingrowth. the covered sems has a membrane that prevents ingrowth through the mesh wall and consequently shows lower rate of re-stenosis than uncovered sems. however, covered sems has a higher risk of stent migration compared to uncovered sems. recent prospective, randomized study showed that there was no significant difference between uncovered and covered sems in terms of stent patency rate as well as technical and clinical success rates. recently the investigators developed new covered sems for gastric outlet obstruction. this new covered sems has features that may contribute to reducing migration rate: 1) partially covered design; 2)less radial force in central portion of stent; 3) presence of lasso which enable position of stent to be adjusted after deployment; 4)presence of protrusion in both sides of stent. this prospective, randomized study aimed to compare the effectiveness and side effects of newly developed covered sems with those of uncovered sems in patients with malignant gastric outlet obstruction from gastric cancer.


Eligibility criteria:
inclusion criteria: * age: 20-80 * patients with gastric outlet obstruction due to gastric adenocarinoma * patients with inoperable gastric adenocarcinoma due to distant metastasis or severe comorbidity * gastric outlet obstruction score: 0-2 * symptoms consistent with gastric outlet obstruction such as nausea or vomiting * findings consistent with gastric outlet obstruction in upper endoscopy or abdominal computed tomography exclusion criteria: * previous history of stent insertion or endoscopic dilation for gastric outlet obstruction * previous history of bypass surgery for gastric outlet obstruction * multiple level of bowel obstruction confirmed in radiographic studies such as small bowel series or abdominal computed tomography * borrmann type iv advanced gastric cancer
involvement of polyomaviruses in the pathogenesis of autoimmune thyroiditis and goitrigenesis.

Conditions: Polyoma Virus Infection; Thyroiditis, Autoimmune

Summary: autoimmune thyroiditis and goitres are frequent pathologies.

autoimmune thyroiditis and goitres are frequent pathologies. on a predisposing genetic ground, environmental factors are potentially at their origin. viral infections are the main factors involved in autoimmunity (herpes virus, viral hepatitis c, erythrovirus b19 ..). however some viruses have an oncogenic potential and could be involved in goitrigenesis. it is also possible that some viruses are specifically implicated in the pathogenesis of graves' disease or hashimoto thyroiditis which combines goitre and autoimmunity. the intrathyroidism of the viral genome of a polyomavirus, the bk virus, has recently been reported in patients with goitre or cancer. the bk virus is a small ubiquitous virus of 40 nm diameter with double-stranded dna contained in a non-enveloped icosahedral capsid. it is mainly known for triggering renal and bladder pathologies including urothelial tumors in the immunocompromised patient, tubulo-interstitial nephropathy in the renal transplant patient, as well as hemorrhagic cystitis in the patient grafted to the bone marrow.

Eligibility criteria:
inclusion criteria: * major patient age ≥ 18 years * patients referred to the ent service of the chu of amiens for thyroidectomy in the context of a goitre, a graves' disease or a thyroiditis of hashimoto. * patients must have signed informed consent. * affiliation to a social security scheme exclusion criteria: * minor patients, * patient under tutorship or curatorship.
boostrix® pregnancy registry

Conditions: Pertussis

Summary: the purpose of this registry is to detect and describe any abnormal pregnancy outcomes, including teratogenicity, in females intentionally or unintentionally exposed to boostrix during their pregnancies in the us. the registry requires voluntary, prospective reporting of eligible pregnancies by patients and health care providers (hcps). data such as vaccination with boostrix during pregnancy or within 28 days preceding conception, potential confounding factors (such as exposure to other medications) and information related to the outcome of the pregnancy will be collected prospectively

the registry was originally initiated on 03 may 2005, as part of a program of enhanced pharmacovigilance. following new european union pharmacovigilance legislation, pregnancy registries are to be considered as post-authorization safety studies (pass). the ongoing registry will therefore be converted into a pass study in q1 2014. exposed pregnancies reported to the registry before the transition into a pass (between 03 may 2005 and q1 2014), from which data were collected and analyzed prospectively, will also be included in the analyses. some pregnancy exposures may be reported after pregnancy outcome has been identified (retrospective reports). the registry will capture retrospective reports, but these reports will not be included in the analyses of prospective reports. pregnancy outcome data will be collected using questionnaires within 2 months of the estimated date of delivery (edd) and approximately 6 months and 12 months after the edd (for all live births for whom the contact details of their hcp will be available) to ascertain the presence of birth defects not diagnosed before, from q1 2014 to q3 2019.

Eligibility criteria:
inclusion criteria: a subject will be included in the registry if all of the following criteria are met: * exposure to vaccine occurs during pregnancy or within 28 days preceding conception. * subject is a us resident. * a hcp is identified (name, address and phone number). * subject can be identified (by gsk or hcp). data from registered subjects will be included in the analyses if the following criterion is met: • pregnancy is ongoing and the outcome is unknown. exclusion criteria: data from registered subjects will not be included in the analyses if the following criterion is met: • outcome of pregnancy is known at the time of initial report. types of known outcomes include prenatal testing reports in which the results are abnormal or outside the reference range, indicating possible abnormality in the fetus. typically, pregnancies \> 16 weeks gestation will have undergone prenatal testing that can identify whether a child has congenital abnormalities.

Keywords: pregnancy registry boostrix women cohort prospective pregnancy outcome exploratory