Kornimate/medical-research-clean huggingface dataset:
study of gabapentin extended release (g-er) in the treatment of vasomotor (hot flashes/hot flushes) symptoms in postmenopausal women

Conditions: Hot Flashes

Summary: depomed's gabapentin extended release is an investigational, extended release formulation of gabapentin that is being studied for the treatment of hot flashes in postmenopausal women.

the primary objective of this clinical trial is to determine the optimal dose of gabapentin er in reducing the number and severity of hot flashes in postmenopausal women. patients will be randomly assigned to gabapentin er or placebo, with a 1 in 4 chance of getting placebo. the total study investigational treatment duration after screening and baseline will be 13 weeks. the primary endpoint of the trial is to compare the number and severity of hot flashes during the investigational treatment compared to baseline. sleep quality will also be evaluated.

Eligibility criteria:
inclusion criteria: 1. generally healthy, postmenopausal women who seek treatment for hot flashes. 2. patients using hormone replacement therapy (hrt) must be willing to discontinue treatment. 3. patients must be experiencing at least 7 moderate to severe hot flashes per day. 4. patient must be willing to commit to 3 (optionally 4) overnight stays at the study site that will include frequent blood sampling. other inclusions apply. exclusion criteria: 1. patients with hypersensitivity to gabapentin. 2. patients with severe chronic diarrhea, chronic constipation, uncontrolled irritable bowel syndrome (ibs) or unexplained weight loss. 3. patients treated with estrogen pellets or injectable progestin drug therapy within 6 months. other exclusions apply.

Keywords: hot flashes hot flushes postmenopausal symptoms
study to assess efficacy, safety, tolerability and pharmacokinetics of pf-07038124 ointment in participants with atopic dermatitis or plaque psoriasis

Conditions: Atopic Dermatitis; Plaque Psoriasis

Summary: this study is being conducted to provide data on efficacy, safety, tolerability and pk of pf-07038124 ointment versus vehicle control in the treatment of mild to moderate ad and mild to moderate plaque psoriasis.


Eligibility criteria:
inclusion criteria: * atopic dermatitis (ad): have been diagnosed with ad for at least 3 months; have an investigator's global assessment (iga) score of 2 (mild), or 3 (moderate); have ad covering 5% to 20% (inclusive) of bsa. * plaque psoriasis: have been diagnosed with plaque psoriasis (psoriasis vulgaris) for at least 6 months; have a physician global assessment (pga) score of 2 (mild), or 3 (moderate); having plaque psoriasis covering 5% to 15% (inclusive) of bsa. exclusion criteria: * presence of skin comorbidities that would interfere with study assessment or response to treatment. * current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurological disease. * other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

Keywords: atopic dermatitis, plaque psoriasis
butyrate adjuvant therapy for type 1 diabetes

Conditions: Type1diabetes

Summary: the investigators are interested to evaluate the effect of bkr-017 (colon-targeted 500 mg butyrate tablets) as adjuvant therapy on metabolic control in type 1 diabetes (tid) subjects.

this study will test effect of bkr-017 (colon-targeted 500 mg butyrate tablets) as adjuvant therapy in type 1 diabetes (tid) subjects on metabolic control in this population. insulin sensitivity, glucose control (variability) and triglycerides will be measured after 8 weeks of treatment and compared to baseline.

Eligibility criteria:
inclusion criteria: 1. all type 1 diabetes with c-peptide (cpr) less than 0.5 ng/ml subjects who are \> 20 and \<80 years of age recruited from the mayo clinic endocrinology clinic; 2. will also meet hba1c level of 6.4-8.9% and bmi of \< 30 kg/m2 at week -4. exclusion criteria: 1. except for the use of insulin, no other treatments for t1d will be permitted. 2. pregnancy 3. inability or unwillingness of individual or legal guardian/representative to give written informed consent.

Keywords: butyrate
perioperative toripalimab (js001) combined with neoadjuvant chemotherapy in patients with resectable locally advanced thoracic esophageal squamous cell carcinoma

Conditions: Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

Summary: this is a randomized, placebo-controlled, multi-center, double-blinded, phase iii study to determine the efficacy and safety of patients with locally advanced squamous cell carcinoma of the thoracic esophagus treated with perioperative immunotherapy combined with neoadjuvant chemotherapy versus placebo combined with neoadjuvant chemotherapy.


Eligibility criteria:
patients must fulfill all of the following inclusion criteria to be eligible for enrollment in this study: 1. histologically confirmed locally advanced (t1n1-3m0 or t2-3n0-3m0) squamous cell carcinoma of the thoracic esophagus (per the 8th edition of uicc-tnm classification); 2. no suspicious cervical lymph node metastasis on cervical contrast-enhanced ct; no systemic metastasis from radiological examination; 3. expected to be achievable to conduct r0 resection. patients must not enter this study if any of the following exclusion criteria is fulfilled: 1. having malignant tumors other than esophageal carcinoma within 5 years prior to randomization; 2. combined with other inoperable condition; 3. previous serious allergy to chemotherapeutic agents (paclitaxel or cisplatin) or any monoclonal antibody; 4. combined with other conditions unsuitable for participation in this study as judged by investigators. other protocol defined inclusion/exclusion criteria could apply.
the effect of reiki therapy in pediatric oncology patients

Conditions: Reiki

Summary: the study was conducted based on randomized controlled experimental design with double-blind, pre-test-post-test to determine the effect of reiki applied to pediatric oncology patients aged 5-7 years on pain, vital signs, oxygen saturation (spo2) and quality of life. while the population of the study consisted of oncology patients aged 5-7 years who were hospitalized in the pediatric oncology services between december 2020 and november 2021, the sample consisted of 66 children diagnosed with leukemia who met the sample selection criteria. the research consists of 3 groups. these groups are reiki group (n=22), placebo group (n=22), control group (n=22). the data are collected using introductory information form, wong-baker faces pain scale (w-bps), vital signs follow-up form, the pediatric quality of life inventory (pedsql) 3.0 cancer module child and parent form. reiki was applied to the reiki group for 20-30 minutes for three consecutive days and placebo was applied to the sham reiki group by an independent nurse during the same application period. the children in the control group were like the routine of the ward.

the universe of the study consisted of pediatric oncology patients who met the selection criteria in the pediatric oncology services. the study was planned as a randomized controlled experimental design with double-blind, pre-test post-test to determine the effect of reiki applied to pediatric oncology patients aged 5-7 years on pain, vital signs, oxygen saturation (spo2) and quality of life. in order for the groups to be distributed homogeneously, the order produced by a computer program (http://www.randomization.com , balanced permutation) was used. patients who meet the inclusion criteria and agree to participate in the study assigned to the experimental and control groups according the randomization list. the control variable of the study is demographic characteristics of the children. the dependent variables of the study are pain, vital signs, oxygen saturation parameters and quality of life score.

Eligibility criteria:
inclusion criteria: * being treated in the pediatric oncology service at the time of the study * being between 5-7 years old * body temperature being within normal limits * to have received at least 1 course of chemotherapy * absence of visual, auditory problems or mental retardation at a level that can fill the scales, exclusion criteria: * to have taken analgesic medication in the last 6 hours, * have received any energy and body-mind therapy (yoga, reiki, massage, meditation, healing touch) in the last six months

Keywords: reiki touch therapy pediatric oncology pain quality of life vital signs
german corneal cross linking register

Conditions: Keratoconus

Summary: corneal cross linking is new treatment modality for patients with keratoconus. a keratoconus is characterized by progressive bulging and thinning of the eye's cornea. keratoconus is a potentially severely sight impairing condition that may necessitate corneal transplantation in the progressive state. corneal cross linking is designed to * increase the cornea's mechanical stability * to stop progression of bulging and thinning of the cornea * to prevent the need for corneal transplantation corneal cross linking is performed by 1. applying riboflavin (vitamin b2) eye drops every 2 minutes for 30 minutes to the cornea 2. illuminating the cornea with uv-light this register of corneal cross linking procedures performed in germany serves to * gather long-term results * detect rare complications and side-effects * evaluate the efficacy in a large number of patients


Eligibility criteria:
inclusion criteria: * patients diagnosed with keratokonus and treated with corneal cross linking in germany exclusion criteria: * non-ectatic conditions

Keywords: keratoconus cornea cross linking uv-light riboflavin
post-licensure, modified double-blind, multi-center study evaluating safety and immunogenicity of adacel® and boostrix®

Conditions: Pertussis; Tetanus; Diphtheria

Summary: this is a descriptive study to evaluate the safety and immunogenicity of adacel® and boostrix® vaccines among us adolescents.


Eligibility criteria:
inclusion criteria: * aged 11 - 18 years of age at the time of vaccination in this trial * signed institutional review board (irb)-approved informed assent / consent form. * able to attend all scheduled visits and to comply with all trial procedures. * for a female, negative serum/urine pregnancy test. exclusion criteria: * any condition which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine. * serious chronic disease (i.e. cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric etc) that is unstable or that might: * interfere with the ability to participate fully in the study; or * interfere with evaluation of the vaccine. * known or suspected impairment of immunologic function. * febrile illness within the last 72 hours or an oral temperature ≥ 100.4°f (≥ 38°c) at the time of inclusion. * history of documented tetanus, diphtheria or pertussis disease within the preceding 5 years. * known or suspected receipt of a tetanus or diphtheria-containing vaccine within the preceding 2 years. * known or suspected receipt of a pertussis-containing vaccine within the preceding 5 years. * administration of immune globulin or other blood products within the last three months, or injected or oral corticosteroids or other therapy expected to materially alter immune function within six weeks of the study vaccine. individuals on a tapering dose schedule of oral steroids lasting less than 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment. * received any vaccine in the 21-day period prior to enrollment or scheduled to receive any vaccination after enrollment and prior to visit 2. * suspected or known hypersensitivity to any of the vaccine components or to latex.

Keywords: tetanus diphtheria acellular pertussis
prospective, non-interventional study to evaluate the effectiveness of elocta compared to conventional factor products

Conditions: Hemophilia A

Summary: the purpose of the study is to evaluate the effectiveness of elocta compared to conventional factor products in the prophylactic treatment of patients with haemophilia a over a 24-month prospective period. data will also be collected for a 12 month retrospective period.


Eligibility criteria:
inclusion criteria: * male patients with a diagnosis of haemophilia a * received prophylactic treatment with a factor product for management of haemophilia a in the 12 months prior to enrolment * at enrolment prescribed prophylactic treatment with elocta or conventional factor product regardless of participation in the study * having at least 12 months documented pre-study treatment data regarding prophylactic treatment prescriptions and bleeding episodes prior to the baseline visit * signed and dated informed consent provided by the patient or the patient's legally acceptable representative for patients under the legal age before any study-related activities are undertaken. assent should be obtained from paediatric patients according to local regulations exclusion criteria: * enrolment in a concurrent clinical interventional study involving intake of an investigational medicinal product (imp), within 1 year prior to enrolment * previously treated with commercially available extended half-life products other than elocta * presence of factor viii inhibitors (≥0.60 bethesda unit \[bu\]/ml ) at the latest available inhibitor test using the nijmegen modified bethesda assay

Keywords: blood coagulation disorders hematologic diseases coagulation protein disorders hemorrhagic disorders genetic diseases, inborn
reversibility of dual antiplatelet therapy by platelets

Conditions: Bleeding

Summary: the objective of the study is to test the hypothesis whether or not autologous stored platelets are able to offset the antiplatelet effect of aspirin and clopidogrel as assessed by state-of-the-art platelet function assays.

dual antiplatelet therapy with aspirin and clopidogrel is a well established strategy to prevent thrombotic complications in patients with high platelet reactivity following plaque rupture in acute coronary syndromes (acs) or percutaneous coronary interventions. current practice guidelines for antiplatelet therapy advocate a one to 12 months dual antiplatelet therapy after bare metal stent pci and a 12 months dual antiplatelet therapy after pci in patients with acs and drug eluting stent pci. although oral antiplatelet therapy is associated with both, short- as well as long-term clinical efficacy, irreversible platelet inhibition carries a substantial risk of bleeding particularly in patients presenting for surgery. empiric therapy of bleeding consists of platelet transfusion. however, there are currently no pharmacodynamic studies assessing the effect of stored platelets on in-vitro platelet function tests. healthy volunteers will donate platelets, take aspirin and clopidogrel for 3 days (loading dose aspirin 300 mg, clopidogrel 300 mg, maintenance dose aspirin 100 mg, clopidogrel 75 mg) and platelets will be retransfused on the 4th day. pharmacodynamic measurements of platelet function will be performed at baseline, after drug intake before retransfusion, immediately after retransfusion and 24 hours thereafter.

Eligibility criteria:
inclusion criteria: 1. informed consent 2. healthy volunteers, male or female (after exclusion of pregnancy if they are on birth control pill or have a contraceptive coil implanted) 3. age of consent 4. weight: 70 kg - 100 kg 5. platelet count 240 000 to 440 000/µl 6. hematocrit \> 40% 7. readiness to refrain from any activities prone to injury during the study period. exclusion criteria: 1. allergy against aspirin or clopidogrel 2. history of bleeding 3. history of peptic ulcer 4. intake of aspirin or nsar during the last ten days before screening 5. gastrointestinal disease precluding resorption of aspirin and clopidogrel 6. scheduled surgery 7. any current medication 8. history of hepatic disease 9. 20µm adp induced aggregation \< 60% at screening 10. cyp2c19 polymorphisms 11. donation of blood within the preceding 4 weeks 12. neurotic disease 13. current smoking 14. drug addiction 15. intake of grapefruits during the last 10 days before

Keywords: aspirin, clopidogrel, pharmacodynamics, platelet transfusion
natalizumab in preventing post-partum relapses in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to evaluate if monthly natalizumab, initiated after delivery, is effective in preventing postpartum relapses.

postpartum patients with a diagnosis of multiple sclerosis (ms) will be given the opportunity to enroll in this study that will evaluate the efficacy of iv natalizumab to prevent postpartum relapses. natalizumab, administered as 300mg iv q 4 weeks, will be initiated postpartum (0-30 days post-delivery). patients who decline natalizumab treatment postpartum will be given the opportunity to enroll in the study in the control group. the control group will have similar inclusion and exclusion criteria as well as scheduled visit and study procedures as the active natalizumab treatment group. the primary objective of the trial is to assess the efficacy of iv administered natalizumab, monthly for 1 year, in preventing relapses during the postpartum period. the secondary objectives of the trial are to assess the efficacy of natalizumab in decreasing the risk for disability progression during the postpartum period and to prevent the appearance of new and/or enlarging brain mri lesions as measured by qualitative mri analysis. the tertiary objective is to assess the association of the clinical outcomes with subject evaluations including patient reported outcomes.

Eligibility criteria:
inclusion criteria: 1. female subjects postpartum, 0-30 days postpartum at the time of informed consent. 2. diagnosis of relapsing form of ms. 3. willing to initiating natalizumab and enroll in the touch system. 4. willing and able to comply with the study procedures for the duration of the trial. 5. signed informed consent and hipaa authorization. exclusion criteria: 1. diagnosis of primary progressive ms. 2. breastfeeding 3. use of ivig in tysabri treated subjects. 4. significant renal or hepatic impairment (in the opinion of the investigator) or other significant disease (e.g., cognitive impairment) that would compromise adherence and completion of the trial. 5. history of hypersensitivity to previous exposure or presence of antibodies to natalizumab. 6. any other factor that, in the opinion of the investigator, would make the subject unsuitable for participation in this study. 7. patients that experience relapses and/or initiated dmt's during pregnancy the control group will consist of relapsing ms patients post-delivery who decline natalizumab therapy but open to enroll in the study. similar inclusion and exclusion criteria as the natalizumab group with the exception of requiring touch enrollment program. the control group will be allowed to initiate any fda approved dmt at any time post delivery or remain on no therapy while breastfeeding.
mobile behavioral parent training for childhood adhd: a micro-randomized trial

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the goal of the study is to develop and refine a personalized behavioral parent training intervention for caregivers of children with attention deficit hyperactivity disorder (adhd). the behavioral intervention will teach positive parenting through videos and quizzes that caregivers can access through a smartphone application. the program also gives parents and caregivers in-the-moment feedback their use of parenting strategies. the current study, a micro-randomized trial, aims to see whether the in-the-moment feedback given to parents (a push notification on their smartphone) changes parenting behavior right after the feedback. micro-randomized means that parents are randomly assigned repeatedly, in this study multiple times per day, to receive or not receive parenting feedback or suggestions on their smartphones. the main questions to answer are: is parenting feedback provided by a smartphone application acceptable to caregivers? when parents receive the feedback, do they use more positive parenting skills in the next few minutes compared to when they do not receive the feedback? is the phone application usable and acceptable to parents and caregivers of children with attention deficit hyperactivity disorder?


Eligibility criteria:
inclusion criteria: * currently meets diagnostic statistical manual 5 diagnostic criteria for adhd * ages 7 -12 * has parent-reported impairment in homework performance defined as a score of 3 or greater on an impairment rating scale measure (fabiano et al., 2006) of homework performance * has at least one parent or primary caregiver who is willing to participate and is able to access the intervention at home via smartphone. exclusion criteria: * n/a
efficacy of olibra: a 12 week controlled trial

Conditions: Overweight; Obesity

Summary: today's obesogenic environment, favors behavioral choices that lead to an excess of energy intake over expenditure, and consequently weight gain. intervention strategies that harness the body's own appetite and satiety regulating signals could provide an effective means of countering excessive energy intake. the purpose of this study was to investigate whether a vegetable oil emulsion (olibra) would result in weight loss that was associated with a reduction in food intake.

71 healthy subjects were enrolled (60 females, 11 males; age: 18 - 60 years, bmi 25 - 40 kg/m2) in a two-phased, randomized, placebo-controlled, double-blind, parallel trial. during a 12-week period, olibra was compared with a placebo (milk fat). food intake testing was conducted on three days and anthropometric data was collected on 7 days. key outcome measures were, body weight, body composition, energy intake, and appetite ratings.

Eligibility criteria:
inclusion criteria: * healthy subjects of both sexes 18 - 60 years of age * body mass index (bmi) between 25 and 40 kg/m2, inclusive exclusion criteria: * (1) participation in another clinical trial or receipt of an investigational product 30 days prior to enrollment * (2) a dietary restraint score of \> 13 * (3) weight loss of 4.5 kg or more in the preceding three months * (4) use of tobacco products, nicotine gum or nicotine patch * (5) a medical condition or taking regular medication except oral contraceptives and hormone replacement therapy * (6) use of a nutritional product or dietary supplement or program which might interfere with the conduct of the study or place the subject at risk * (7) history of alcohol or other drug abuse in the preceding one year * (8) pregnancy, lactation, post-partum less than six months, planning a pregnancy during the study or not using an acceptable method of contraception * (9) fasting blood sugar ≥ 126 mg/dl * (10) known allergy or sensitivity to any ingredient in the supplement * (11) clinically significant deviations in normal laboratory values * (12) irregular meal-times, and * (13) unwilling to eat yogurt at test meals.