Kornimate/medical-research-clean huggingface dataset:
dietary intake in adults from the ga2len folow-up survey

Conditions: Asthma; Lung Function Decreased; Food Allergy; Allergic Sensitisation; Allergic Rhinitis; COPD; Atopy

Summary: the nutrition study of the ga2len follow-survey was designed to investigate the association between usual dietary intake and allergic and respiratory outcomes in adults across europe. within this framework, a food frequency questionnaire (ffq) was designed to ascertain usual dietary intake of 250 food items, which was translated into the languages of the participant centres. information on daily intake of foods, nutrients, and flavonoids was derived.

within the ga2len follow-up survey, the nutrition survey was aimed at assessing dietary intake in adults across european countries and its association with various outcomes of allergy and respiratory health. in absence of an internationally comparable dietary questionnaire to ascertain usual dietary intake, a single and standardized food frequency questionnaire (ffq) was design to be used as a common instrument in all participant countries. the ffq is comprised of 32 food sections and 250 food items. the ffq sections were designed following the recommendations by the efcosum group, which facilitate international comparisons of dietary intake. it also included several staple foods to capture locally representative dietary intake. participants reported how often they had consumed each of the foods over the previous month, using eight predefined options (rarely or never, 1-3 times per month, once, 2-4, or 5-6 times per week, once, 2-3 times per day). standard food portion sizes were used to quantify the intake following the recommendations from the uk's food standards agency. daily intake of foods (g) were estimated and macro- and micronutrient and flavonoid intakes were derived. the ga2len ffq was validated in five eu countries, namely finland, uk, portugal, germany, poland, and greece, and demonstrated to be a good tool to assess mid-term intake of foods, specifically essential polyunsaturated fatty acids (pufas). the instrument has also been demonstrated to be an accurate tool to assess dietary sources of flavonoids. various approaches were planned to derive dietary exposures and to examine their association with respiratory and allergic outcomes. these included the use of dietary patterns derived from principal component analysis (pca), a dietary inflammatory index (dii), as well as single antioxidants, and individual food items.

Eligibility criteria:
inclusion criteria: participants aged 15-75 years old, who had responded to the ga2len baseline survey and who met the definition of cases or controls (as described below) exclusion criteria: participants who did not answer the baseline survey

Keywords: asthma adults europe lung function allergy atopy ige sensitisation diet dietary patterns dietary antioxidants flavonoids fruits and vegetables food frequency questionnaire (ffq) fatty acids
a study to evaluate the effect of food on the pharmacokinetics of vx-548

Conditions: Pain

Summary: the purpose of this study is to evaluate the pharmacokinetics (pk), safety, and tolerability of vx-548 in healthy participants.

this clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(a) of the public health service act and 42 cfr 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the public health service act or 42 cfr 11.24 and 11.44.).

Eligibility criteria:
key inclusion criteria: * body mass index (bmi) of 18.0 to 35.0 kilogram per meter square (kg/m\^2) * a total body weight greater than (\>) 50 kilogram (kg) key exclusion criteria: * history of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug * any condition possibly affecting drug absorption * participants of childbearing potential other protocol defined inclusion/exclusion criteria may apply.
capsule endoscopy in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: cystic fibrosis patients continue to have bowel problems even after adequate pancreatic enzyme supplementation. there may be pathology of the lining of the bowel. capsule endoscopy will be used to photograph the entire bowel.

the capsule endoscope system (given imaging, ltd.) consists of 3 elements: a disposable capsule (pillcamtm sb) that acquires video images during natural propulsion through the digestive system. the video-capsule pillcamtm sb has been cleared by the fda for use in patients over 10 years of age for the detection of small intestinal disorders. it has been used in patients under age 10 and has been placed with the use of a gastroscope in patients unable to swallow the capsule. in fact, a new delivery device has been introduced recently that facilitates placement of the video-capsule in pediatric patients.for the purposes of this study, only patients over age 10 years who are able to swallow the capsule would be enrolled. there are approximately 450 cf patients in the registry in israel, with about 300 above the age of 10. study subjects would be enrolled from this registry population and would be screened for the presence of the contraindications noted above. patients would be assessed for symptoms of possible small bowel lesions at the time of enrollment including gastrointestinal bleeding, palpable abdominal mass, weight loss, diarrhea, and abdominal pain. markers of inflammation including stool calprotectin will be assessed in all patients. these data would be recorded for further analysis. page

Eligibility criteria:
inclusion criteria: inclusion criteria would include those subjects with known cf who are able to give informed consent to undergo capsule endoscopy and whose guardians provide consent as well, if applicable. - exclusion criteria subjects would be excluded if they were felt to be poor surgical candidates as patients may need to undergo surgery in the rare event of retention of the capsule. patients genotype and lung function will be noted; patients will be excluded if fev1 \< 40%. -

Keywords: capsule endoscopy
obesity: an underappreciate risk factor for severe form of covid-19

Conditions: COVID-19 Pandemic; Obesity

Summary: our study has the objective of identifying the epidemiological profil of the patients, as well as, the clinical, radiological and prognosis of obese patients with covid 19.

introduction: covid 19 pandemic continues to progress with a considerable mortality and morbidity throughout the world since its emergence in december 2019. many studies were conducted to identify the predictive factors of mortality of those infected with the virus. the previous studies noticed that obesity seems to be associated with severe form of respiratory distress syndrome. our study has the objective of identifying the epidemiological profil of the patients, as well as, the clinical, radiological and prognosis of obese patients with covid 19. methods: investigators led a retrospective monocentric, descriptive and analytic study, in the department of anesthesia and intensive care unit of the university hospital of mohamed vi oujda, in morocco, from march 2020 to october 2021, including all the patients tested positive for the infection.

Eligibility criteria:
inclusion criteria: * all patients presenting an infection with sars-cov-2 that were hospitalized in the intensive care unit. exclusion criteria: * none
anesthetic technique for av fistulae creation

Conditions: End Stage Renal Failure on Dialysis

Summary: this study is being done to compare the two anesthesia techniques which are commonly used in the formation of arteriovenous fistulas: local anesthesia and regional anesthesia. local anesthesia means that, your doctor will inject numbing medication directly into the tissue or part of your body where the surgery will be done. in this case, the numbing medication will be injected directly into the area where your fistula will be made. in regional anesthesia, the numbing medication will be injected around the nerve (part of the body that gives sensation) for your arm, to make the entire arm numb. the purpose of this study is to compare the three month success rates of av fistulae created by the two anesthesia techniques.

the primary objectives of the study are: 1. to evaluate the three-month success rate for av fistulas constructed while using regional anesthesia against those constructed while using local anesthesia. success will be evaluated by a dialysis access ultrasound, which will be performed three months after completion of the procedure. successful will be defined as a mean blood flow of 600 ml/min and above, or receiving hemodialysis using the newly created av fistula. 2. to evaluate the immediate (within 3 days) and long-term complications three months after av fistula construction under regional anesthesia or local anesthesia. the secondary objective of the study is to use a short questionnaire survey to assess patient comfort level after creation of av fistula (e.g. nausea, analgesia).

Eligibility criteria:
inclusion criteria: * age 21-70 years old * able to give informed consent * creation of first time av fistula * possible 3 month follow up visit * asa-i-iv exclusion criteria: * bmi ≥40 * repeated av fistula creation, * asa -v, * allergic to local anesthetic agents, * significant lung and cardiac disease, * infection at the site of regional anesthesia, * pre-existing peripheral nerve damage, * significant bleeding disorders,

Keywords: hemodialysis and av fistula
osteopathy treatment for cancer pain related to the confinement to bed

Conditions: Cancer Patient Confined in the Bed

Summary: staying confined in the bed is frequent at the end of life. the cancer patients can also experiment this situation, and consequences are painful, with pain increasing with the time. this pain are related to the joints stiffing , muscles mass decreasing, and tendons retractions . the non pharmacological approach associated with the conventional treatments can be interesting to assess in this frails patients.


Eligibility criteria:
inclusion criteria: * man or woman * aged 18 years or older * having signed informed consent to participate in the study * patient affiliated to a social security scheme * patient with pain affecting the musculoskeletal system following prolonged bed rest * capable to understand french * capable of completing self-assessment scales exclusion criteria: * patients with bone metastases at risk for the use of osteopathy * patients under legal protection measures * patients with cognitive impairment preventing self-evaluation * patient who is considered too fragile or with a clinical condition too unstable by the doctor refer to be included in the study * patients in the pre-agonic or agonic phase

Keywords: advanced cancer osteopathy pain bedridden
determine: detemir vs nph

Conditions: Gestational Diabetes; Diabetes Mellitus, Type 2

Summary: the purpose of the study is to compare rates of neonatal hypoglycemia with maternal nph vs determir use.

insulin detemir has been used and is fda approved for type 1 diabetes in pregnancy women and its safety has been well established. at this point, the only long or intermediate acting medication that is approved for type 2 diabetes or gestational diabetes is insulin nph. the most serious side effect of insulin detemir is hypoglycemia but the rates of hypoglycemia are lower when comparted to nph both during pregnancy and outside of pregnancy. diabetes mellitus (dm) is the most common diagnosis in pregnancy and its incidence is continuing to increase. recent epidemiologic reports place the risk of pre-gestational diabetes at 1-2% and gestational diabetes (gdm) at 12.5%. risk factors for type 2 diabetes (t2dm) and gdm include obesity, hypertension, family history of diabetes, polycystic ovarian syndrome, or excessive weight gain in pregnancy. suboptimal control of dm in pregnancy confers significant morbidity on both the mother and fetus, including increased risk of preeclampsia, preterm delivery, perineal lacerations, cesarean delivery, neonatal hypoglycemia, and nicu admissions.

Eligibility criteria:
inclusion criteria: * inclusion criteria will include pregnant women with pre-existing t2dm and gdm who requiring insulin to manage their blood sugars in pregnancy. exclusion criteria: 1. multiple gestation 2. type 1 diabetes mellatus 3. age \< 18 4. known or suspected hypersensitivity to nph or insulin detemir 5. known fetal major malformations 6. chronic renal or hepatic insufficiency 7. known to be hiv, hepatitis b, or hepatitis c positive 8. indication for planned premature delivery (placenta accrete, or prior classical cesarean delivery) 9. insulin dependent before conception
safety, tolerability, and efficacy of immunomodulation with at-1501 in combination with transplanted islet cells in adults with brittle t1d

Conditions: Brittle Type 1 Diabetes Mellitus

Summary: this study will evaluate the safety, tolerability and efficacy of at-1501 in an immunomodulation regimen in adult patients with t1d undergoing an islet cell transplant.

this study will evaluate the safety, tolerability and efficacy of transplantation of experimental islet cells as a potential treatment for brittle type 1 diabetes mellitus. it will also assess the safety, tolerability and efficacy of at-1501 in an immunomodulation regimen in adult patients with brittle t1d undergoing an islet cell transplant. this is a single arm open-label study and up to 6 participants will be recruited at a single center in the united states. the objectives include: * to assess the safety and tolerability of transplanted islet cells and immunomodulation with at-1501, in combination (at+) with rabbit anti-thymoglobulin (atg), etanercept and mycophenolate mofetil (mmf/ec-mps) in adults with t1d undergoing islet cell transplant. * to assess the efficacy of transplanted islet cells and immunomodulation with at-1501 in adults with brittle t1d undergoing islet cell transplant. the duration of treatment may vary from participant to participant and could be up to 2 years. participants may receive up to 2 islet cell transplants.

Eligibility criteria:
inclusion criteria: * men and women 18-65 years of age * a diagnosis of t1d ≥5 years with onset of disease at \<40 years of age * involvement in appropriate diabetes management in accordance with the standard of care, as directed by an endocrinologist or diabetologist with at least 3 clinical evaluations within the 12 months prior to screening; using an insulin pump or multiple daily injection (mdi) insulin therapy; and, unable to achieve acceptable metabolic control because of the occurrence of unexplained shes * at least 3 unexplained shes not secondary to a missed meal or dosing error, in the 12 months prior to screening * glycosylated hemoglobin (hba1c) level greater than 7% (53 mmol/mol) and less than 9.5% (80 mmol/mol) inclusive * absence of stimulated c peptide (\< 0.3 ng/ml) in response to a mixed meal tolerance test (mmtt) measured at 60 and 90 minutes after the start of consumption * impaired awareness of hypoglycemia (iah) as defined by a clarke score \[clarke 1995\] of 4 or more at the time of screening, during the screening period, and within the last 6 months prior to the transplant exclusion criteria: * any previous solid organ or islet allotransplant * body mass index (bmi) \>30 kg/m2 * insulin requirement \>1.0 unit/kg/day or \<15 units/day

Keywords: at-1501 type 1 diabetes t1d islet cell transplant humanized blocking antibody to cd40l cd40l inhibitor monoclonal antibody glucose metabolism diseases diabetes mellitus type 1 endocrine system diseases graft metabolic diseases immune system diseases autoimmune diseases hypoglycemia hyperglycemia brittle t1d brittle type 1 diabetes
a single group study to evaluate the effects of a boric acid suppository on vaginal health.

Conditions: Vaginal Health; Bacterial Vaginosis

Summary: this is a virtual single-group clinical trial that will last 12 weeks. participants will use the killer® (boric acid suppositories) once daily for 7 consecutive days when they feel that they are experiencing any of the common signs of vaginal imbalance like vaginal malodor, vaginal irritation, and/or vaginal itching. participants will complete a questionnaire before using the product and on days 3 and 7 of using the product. they will also complete a vaginal swab ph test before using the product and after 7 days of using the product (day 8).


Eligibility criteria:
inclusion criteria: * female at birth * aged 18+ * interested in maintaining a calm, soothed, and healthy vaginal environment and balanced vaginal ph levels * regularly experience atypical vaginal smell, discharge, itching, swelling, irritation, pain or - burning during sex, and/or a burning sensation while urinating * willing to avoid introducing any products or new forms of prescription medication or supplements targeting vaginal health during the study period * has used a boric acid suppository before * willing to avoid the use of any intra-vaginal products during the study product use * willing and able to follow the study protocol exclusion criteria: * surgeries or invasive treatments in the last six months or planned during the study period * introduced any products or forms of prescription medication or supplements targeting vaginal health in the last 12 weeks * known allergies to the product ingredients * diagnosed with chronic health conditions impacting participation * pregnant, breastfeeding, or trying to conceive * history of substance abuse * current or former smoker within the past six months * unwilling to follow the study protocol * currently participating in any other clinical trial or perception study

Keywords: vaginal ph balance vaginal flora women's health
multi centre study on tess v2 shoulder system

Conditions: Osteoarthritis Shoulder; Fracture; Rheumatoid Arthritis; Avascular Necrosis; Rotator Cuff Tear; Revision

Summary: this study is a post market clinical follow-up study to fulfill the post market surveillance requirements. the data collected from this study will serve the purpose of confirming safety and performance of the tess shoulder system.

the objective of this retrospective and prospective, multicenter, non-controlled post market clinical follow-up study is to evaluate the mid-term (5-year) clinical performance of the tess version 2 anatomic and reverse prostheses in shoulder arthroplasty. the primary outcome is defined as the clinical performance determined using constant score. the secondary outcomes are the passive and active mobility, the radiographic evaluation, the complications (including dislocation and revisions/removals) and survivorship.

Eligibility criteria:
inclusion criteria: * except in special cases, the "anatomic" type is indicated for: * centered osteoarthritis of the shoulder * humeral head fractures * rheumatoid arthritis (with intact rotator cuff) * avascular necrosis of the humeral head * except in special cases, the "reversed" type is indicated for: * offset osteoarthritis of the shoulder * massive and non-repairable rotator cuff tears * rheumatoid arthritis (with degenerative rotator cuff) * revision in cases of: * replacement of an "anatomic" prosthesis with a "reversed" prosthesis * conversion of a hemi-arthroplasty into a total arthroplasty * increasing the size of the stem (length and/or diameter) * replacing a glenoid prosthesis * replacing a competitor's prosthesis * in rare cases, removing a "reversed" prosthesis and replacing it with an "anatomic" prosthesis * additional inclusion criteria include * patient who read, understood study information and gave informed consent (oral or written depending on specific local regulatory requirements) * willing to return for follow-up evaluations exclusion criteria: * local or systemic infections. * severe muscular, neurological, or vascular deficiency of the affected joint. * bone destruction or poor bone quality liable to affect the stability of the implant (paget's disease, osteoporosis, etc.) * cases where the corolla cannot be two-thirds covered with bone stock and including the stem/corolla junction. * any concomitant complaint likely to affect the functioning of the implant. * allergy to any of the implant components. * local bone tumors. * patient over 18 under law supervision

Keywords: shoulder arthroplasty medical device shoulder prosthesis performance
post-marketing surveillance (use-results surveillance) with esperoct®

Conditions: Haemophilia A

Summary: the purpose of this study is to assess the safety and effectiveness of esperoct® for long-term routine use in patients with haemophilia a. participants will get esperoct® as prescribed by their doctor. the study will last for about 2 years for each participant.


Eligibility criteria:
inclusion criteria: * signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol). * the decision to initiate treatment with commercially available esperoct® has been made by the patient/legally acceptable representative (lar) and the treating physician before and independently from the decision to include the patient in this study. * diagnosis of haemophilia a in males or females, no age limitation. * new patients who have not previously been exposed to esperoct®. exclusion criteria: * previous participation in this study. participation is defined as having given informed consent in this study. * known or suspected hypersensitivity to study product or related products. * mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
modified natural cycle offers a chance of pregnancy in patients with poor response and high basal fsh

Conditions: Infertility; Premature Ovarian Failure

Summary: the purpose of this study is to evaluate the effectiveness of a modified natural cycle in patients with previous poor response to infertility drugs and high basal fsh, prior to proceeding to oocyte donation or abandoning fertility treatment.

poor responders are a diverse group of ivf patients who fail to respond to ivf drugs. in these patients pregnancy rates remain disappointingly low and usually oocyte donation is their only viable option. the need for lengthy ovarian stimulation regimes can be avoided by performing ivf during a natural menstrual cycle. however, the main problem with a natural cycle is that successful ivf outcome can be compromised by a premature lh surge. this problem can be solved by the administration of gnrh antagonists that suppress endogenous gonadotropin levels, comprising a modified natural cycle (mnc). previous studies have shown that mnc offers no realistic chances of pregnancy prior to oocyte donation. in this study we will re-assess this view by showing that mnc offers some, albeit small, chances of positive ivf outcome in patients with known previous poor response prior to oocyte donation.

Eligibility criteria:
inclusion criteria: * regular menstrual cycle (21-35 days) * basal fsh\>12 iu/ml * one or more failed ivf attempts (\<3 oocyte retrieved) exclusion criteria: * pcos * normal responders

Keywords: gnrh antagonist poor responders oocyte donation modified natural cycle