Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the efficacy and safety of ansofaxine hydrochloride extended-release tablets in the treatment of major depressive disorder (mdd)

Conditions: Major Depressive Disorder (MDD)

Summary: the purpose of this study is to determine if ly03005 is effective and safe in improve madrs score, as compared to placebo (no medicine) in participants with major depressive disorder (mdd)

the study consisted of two periods: a screening period of 1 week and a double-blind treatment period (8 weeks). after the screening period, 588 enrolled subjects were randomized into one of 3 study groups in the 1:1:1 ratio, 2 ly03005 treatment groups with different dose or 1 placebo group. subjects were given investigatory drug or placebo according to the protocol, followed up at the end of 1, 2, 4 6, and 8 weeks.

Eligibility criteria:
inclusion criteria: 1. male or female aged 18 to 65 years subjects from outpatients; 2. subjects currently meet the diagnostic and statistical manual of manual disorders, fifth edition(dsm-5) criteria for mdd with either single or recurrent episodes (296.2/296.3) without psychotic characteristics; 3. subjects has a total score of the montgomery- åsberg depression scale (madrs) ≥26 points at screening; 4. subjects has a clinical global impression -severity illness (cgi-s) score≥4 points at screening exclusion criteria: 1. allergic or known to be allergic to venlafaxine and desvenlafaxine; 2. subjects with mdd who were not responsive to the previous venlafaxine treatment with sufficient amount and duration and to at least two different mechanisms of action antidepressants with adequate amount and duration in the past; 3. there is a clear suicide attempt or behavior and score of the 10th item (suicidal ideation) in madrs scale is 4 points or greater; 4. pregnant or lactating women,women who have a planned pregnancy in the near future; 5. subjects meet the diagnostic criteria for other psychotic disorders(except for mdd) in dsm-5, such as schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, obsessive-compulsive and related disorders, post-traumatic stress disorder, separation disorders, anorexia nervosa or bulimia and personality disorder; 6. subjects who meet the diagnostic criteria for substance or alcohol abuse (excluding nicotine or caffeine) 6 months prior to the screening; 7. mdd secondary to other mental illnesses or physical illnesses; 8. those with a history of seizures (except for convulsions caused by febrile seizures in children).
indonesia after discharge lbw infant hmf supplementation study

Conditions: Low; Birthweight; Breast Feeding, Exclusive; Gestational Age and Weight Conditions

Summary: low birth weight (lbw) infant (1800-2449 gram) will be given the new human milk fortifier (hmf) which contains protein, lipid, carbohydrate and micronutrients after discharge. human milk fortifier or placebo (carbohydrate only with similar calorie content) will be provided until 3 months of age. the investigators want to evaluate if the addition of hmf to mother's milk while breastfeeding lbw infants after discharge influences growth and body composition up to 3 months of age.

this is a prospective two arms parallel double-blind randomized clinical trial in lbw infants. clinically healthy lbw infants discharge on oral feeding of human milk before 2 weeks of age (\< 15 days old) will be invited to participate in the study. exclusively or predominantly breastfed infants will be encourage to use finger feeding as method of supplementation, but mothers can choose their own preferences if they wish to do so. after signing the informed consent by parent, subject will be randomized to one of four group. randomization list were prepare by one investigator who do not involve in recruitment, outcome measures and statistical analysis. study product will be labeled as a, b, c d in similar tin. only manufacturer know the content of these tins and the code will be revealed after statistical analysis completed. parents will be given this 200 g tin of study product and ask to return the tin after 14 days of opening. unblinded assistant will weight the tin before and after opening to estimate the hmf intake for 14 days. this study will be conducted in several hospitals in greater jakarta. adherence to study protocol will be encouraged during face to face session initially in dispensing study product and subsequent visits (visit 1 at one-month-old, visit 2 at two months old). these sessions will include the reminder of the importance of following study protocol, breastfeeding support if needed and discussion about difficulties that arise. the investigators will also remind mothers via text to fill in three days diary of intake one week before each visit.

Eligibility criteria:
inclusion criteria: 1. low birth weight infants (1800-2499 g) with oral feeding 2. exclusively breastfed or predominantly breastfed (consuming term infant formula less than 50 ml/kg bw/day) at discharge 3. discharge from the hospital before 2 weeks of age and maximal age of enrolment is 14 days old 4. live in greater jakarta 5. parents agree in writing to study participation and indicate their intention to follow study procedures. exclusion criteria: any subject who has major congenital anomaly or any other disorder(s) that infers with normal feeding, growth, and neurodevelopment. participating in another intervention trial

Keywords: low birth weight breast feeding body mass index human milk fortifier small gestational age
phase 1 study of ct-996 in overweight/obese participants and patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes; Overweight or Obesity

Summary: a study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of ct-996 in overweight/obese participants and participants with t2dm.

a multi-center, randomized, double-blind, placebo-controlled, dose escalation, first in human study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of ct-996 when administered as single and multiple-ascending doses in overweight/obese participants and as multiple doses in patients with t2dm.

Eligibility criteria:
inclusion criteria: * participants 18-65 years old, inclusive * bmi of 25 - 40, inclusive * stable body weight for two months exclusion criteria: * history of significant medical conditions and malignancy * uncontrollable hypertension * history of alcoholism or drug addiction within 1 year prior to screening * current or recent participation in an investigational clinical trial

Keywords: type 2 diabetes obesity overweight
the effect of adding sodium bicarbonate 8.4% to local anesthesia on pain during upper canine infiltration

Conditions: Local Anesthetic Complication

Summary: the aim of the present study was to evaluate the pain during local anesthetic buccal infiltration for the maxillary canines after adding sodium bicarbonate 8.4% during local anesthesia.

materials and methods the present research was approved by the institutional review board of the college of dentistry at al wataniya private university (m/45- 14.1.2023). 30 healthy patients were recruited, aged between 15-50 years, and divided into two groups (15 males and 15 females). every patient had to meet the following conditions: * caries free with no restorations, periapical lesions, or history of trauma at the site of injection. * willingness to participate in the study and ability to describe and evaluate their pain. * no painkillers, or sedatives taken for at least 24 hours so that pain assessment isn't affected. * no allergy to local anesthetics. * no pregnancy. each patient received buccal infiltration with the anesthetic solution alone at one upper canine site and local anesthetic with added sodium bicarbonate at the other site. the local anesthetic used was 2% lidocaine with 1:80.000 epinephrine produced by new-stetic s.a.- colombia. whereas 8.4% bicarbonate sodium was produced by tce - uk. injections were performed using 25 mm short needles (gauge 27) manufactured by c-k dental - south korea. consent for each patient was obtained before the clinical session. local infiltration was performed using a one-third cartridge (0.6 ml) of the local anesthetic on one side and local anesthetic with added sodium bicarbonate on the counterpart side leaving 5 minutes between the injections. alkalinization of the local anesthetic was performed using the technique described by saatchi et al13. 0.2 ml of the anesthetic solution was extracted using a tuberculin syringe and then discarded. 0.2 ml sodium bicarbonate was then loaded and added to the cartridge. afterward, the solution was slowly shaken 20 times and ready to be administered with a cartridge syringe. the 100 mm visual analog scale vas was utilized as the most commonly used assessment tool to determine the severity of the pain14 where 0 indicates that the patient does not feel pain, while 10 points to unbearable severe pain. the patients must rely on their own experience to confirm the pain's severity.

Eligibility criteria:
inclusion criteria: * caries free with no restorations, periapical lesions, or history of trauma at the site of injection. * willingness to participate in the study and ability to describe and evaluate their pain. * no painkillers, or sedatives taken for at least 24 hours so that pain assessment isn't affected. exclusion criteria: * allergy to local anesthetics. * pregnancy

Keywords: upper canine infiltration lidocaine sodium bicarbonate
lipidome and microbiome profile of acne

Conditions: Acne Vulgaris

Summary: lipidome and microbiome analysis in subjects with acne on doxycycline. investigators will look at the skin lipidome, blood lipidome, gut micro biome and skin micro biome. investigators will look at the changes between acne subjects and control participants, but also the changes that occur after the use of antibiotics and how this is altered.

we will look at acne subjects, and controls. we will look at four things 1. skin lipidome 2. skin microbiome 3. gut microbiome 4. blood lipidome investigators will assess this in acne participants before and after doxycycline and compare them to controls.

Eligibility criteria:
inclusion criteria: * aged 15 and older * subjects/parents/legal guardian is able to read and comprehend study procedure and consent forms. * have already been prescribed doxycycline by their physician for acne or to be eligible to be prescribed doxycycline for acne * have acne that is diagnosed by a board certified dermatologist. exclusion criteria: * those who have received systemic antibiotics within four weeks of starting the study. * those who have received systemic isotretinoin within six weeks of starting the study. * those with seborrheic dermatitis, rosacea, or polycystic ovary syndrome * those who are pregnant, prisoners or cognitively impaired. * those subjects who are currently using proton pump inhibits (as studies have shown this may impact the gut microbiome) (4) * those who have a bmi greater than \>30 kg/m2, as studies have shown a reduction in the variability of intestinal microbes within this population (5). * those who have initiated or changed brand of oral contraceptive pill within 4 weeks of starting the study. * those who have autoimmune disorders as this group has been shown to have an altered microbiome (6) * those who have diabetes (6), immunodeficiencies (7), inflammatory bowel disease (6), hypercholesterolemia, as these groups have been shown to have altered gut microbiomes * those who have taken oral probiotic supplements (8) within 4 weeks of starting the study * given the nature of the instructions that need to be adhered to for accurate collection of samples and this data, non-english speaking individuals will be excluded from this pilot study. * allergies to the tetracycline group of antibiotics * those who do not fit the inclusion criteria
effect of exercise with and without hmb on body composition and muscle strength in sickle cell anaemia

Conditions: Sickle Cell Anemia

Summary: wasting is a common and significant problem in sickle cell anaemia (sca) that correlates with poorer clinical outcome such as frequent painful crises, acute chest syndrome and sub normal resistance to infection. thus, improvement of nutritional status in sca holds the potential of ameliorating the course of the disease. elevated haemolysis and its effects are associated with hypermetabolism and have resulted in higher rates of protein breakdown and synthesis, and energy expenditure. offering more food has not optimized nutritional status and metabolic performance in free-living patients with sca. moreover, appetite might be suppressed. supplementation with β-hydroxy-β-methylbutyrate (hmb), which is produced in the body from leucine, has been shown to have inhibitory effect on protein breakdown and to promote lean tissue synthesis in humans with sarcopenia. also, hmb has been implicated as an ergogenic tool to promote exercise performance and skeletal muscle hypertrophy. therefore, the investigators hypothesize that in individuals with sca, an intervention of resistance exercise with hmb supplement will have a greater enhancing effect on muscle mass and strength compared to receiving resistance exercise without hmb.

the investigators aim to measure muscle strength, body composition and whole body protein oxidation in two groups of adults with sca within one week before and after 9 weeks of intervention in a randomized, double blinded study. one group (n =12 ) will receive an intervention of resistance exercise and hmb supplement, and the other group (n=12) will receive resistance exercise and a placebo (maltodextrin). participants will be assigned a study code and all information and samples will be stored under the assigned code.

Eligibility criteria:
inclusion criteria: * bmi \< 18.5 kg/m2 exclusion criteria: * bmi \> 19 kg/m2
neck pain in office workers during covid 19 pandemic

Conditions: Neck Pain

Summary: work content of office workers are using computers, conferences, presentations and talking on the phones. static postures and repetitive writing and reading activities at inappropriate body postures are the most common activities of office workers. decreased physical activity and prolonged computer use cause occupational safety problems and musculoskeletal problems. neck pain is one of the most common problem in office workers and the studies have shown the incidence of neck pain in office workers is 34-49% . the aim of this study to evaluate the effects of remote employee in neck pain in office workers during covid 19 pandemic

the data of study was obtained by using online questionnaire. the questionnaire was generated through google forms and the online questionnaire link was delivered via e-mail to office workers. the questionnaire link was active within 3 months for data collection. the information about study was stated and before answering the questionnaire, all participants were asked whether they were willing to participate in the study and thus all participants have declared voluntary for the study. all participants were employees such as clerical or administrative work in an office. the inclusion criteria were as follows; (a) being an office worker or remote employee; (b) aged between 18 and 55 years; (c). had a diagnosis with myofascial pain in neck. the exclusion criteria were as follows: (a) having a history of surgery in neck region; (b): a diagnosis with skeletal muscle diseases, chronic kidney diseases, chronic liver failure, malignancy and neurologic diseases; (c): having cognitive impairment that affects answering the online questionnaire properly; (d): having internet access and not being able to complete the online questionnaire; (e): being pregnant. the beck depression inventory (bdi), the nottingham health profile (nhp), neck pain and disability scale (npds), pittsburgh sleep quality index (psqi), the nottingham health profile (nhp) and demographic form were obtained

Eligibility criteria:
inclusion criteria: being an office worker or remote employee aged between 18 and 55 years had a diagnosis with myofascial pain in neck. exclusion criteria: * having a history of surgery in neck region a diagnosis with skeletal muscle diseases, chronic kidney diseases, chronic liver failure, malignancy and neurologic diseases having cognitive impairment that affects answering the online questionnaire properly having internet access and not being able to complete the online questionnaire being pregnant

Keywords: neck pain posture
exercise on mitochondrial functions of lymphocyte in hemodialysis

Conditions: Hemodialysis Complication

Summary: to improve aerobic capacity, muscular function and health-related quality of life in patients with end-stage renal disease (esrd), regular exercise is recommended. supervised intradialytic exercise with moderate intensity is an available approach to maintain patients' safety and compliance, and enhance physiological adaptations effectively. the exercise training effects of mitochondrial functions of lymphocyte in esrd patients, like respiratory capacity, bioenergetic status and thrombosis/immunological regulation remained unclear. method: esrd patients (anticipated n=180) would conduct supervised exercise training therapy for 3 days a week for 6 months in the hospital and 3 months at home. cardiopulmonary exercise therapy would be performed before and after the intervention. a high resolution respirometer and a flow cytometer are used to determine the oxygen consumption rate/mitochondrial respiration in mitochondria and subtypes of lymphocyte, respectively.

renal dysfunction results from cardiovascular-related comorbidities or metabolic disorders, accumulating excessive inflammatory products or damage mitochondrial bioenergetics health in platelet and lymphocyte, then lead to chronic kidney disease (ckd) eventually. end-stage renal disease (esrd) is the highest level of ckd, patients at esrd stage suffer from severe uremia and renal failure, preparing renal replacement therapy: dialysis. hemodialysis (hd) are the most common treatment for esrd patients, especially in taiwan, where reports the highest prevalence of hd globally due to related chronic diseases and comprehensive national health insurance program. maintenance (long-term) hd results in physical inactivity and low quality of life; thus, exercise training is recommended to improve physiological adaptations and functional capacity for hd patients. with supervised condition and a safer progression, intradialytic exercise in clinical settings provides low dropout rate and superior compliance. mitochondrial dysfunction is one of the concerned issues in esrd, impaired mitochondria also dysregulate circulating lymphocyte, leading to immunological senescence . the purposes of the present study are to establish the measurements of mitochondrial functions of platelet and lymphocyte in hd patients, and determine cardiovascular and muscular fitness along with the effects of intradialytic exercise.

Eligibility criteria:
inclusion criteria: * all patients have been receiving hemodialysis and medication at least for 6 weeks, the kt/v score must be above 1.2 to show that they were stable. exclusion criteria: * under 20 years-old, hyperkalemia occurs within 3 month, orthopedic or muscular diseases, other medical, psychological or physiological diseases, pregnancy exercise contraindications.

Keywords: hemodialysis mitochondria lymphocyte exercise training
partial breast irradiation using non invasive approach for early stage breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to evaluate the rate of early and intermediate toxicity related to the accuboost system for delivery of apbi in women with resected, early stage breast cancer.


Eligibility criteria:
inclusion criteria: 1. a confirmed histological diagnosis of invasive breast carcinoma or dcis 2. age greater or equal to 50 years old 3. life expectancy \> 6 months 4. treated by breast conserving surgery with axillary node dissection or sentinel lymph node biopsy 5. pathologic tumor size less than or equal to 2 cm 6. invasive ductal, mucinous, tubular or colloid histology 7. estrogen receptor positive for invasive carcinoma. 8. unifocal/unicentric disease 9. negative surgical margins greater than or equal to 2 mm 10. pathologic lymph node negative 11. no evidence of lymphovascular invasion 12. ecog performance status of 0 or 1 (appendix 1) 13. informed consent signed. exclusion criteria: 1. known brca 1/2 mutation; (brca 1 and 2 testing is not required) 2. autoimmune disorder 3. pregnancy 4. breast implants 5. psychiatric or addictive disorder that would preclude attending follow-up 6. neoadjuvant chemotherapy (adjuvant chemotherapy is permitted) 7. suspicious remaining microcalcification on post-surgery mammogram (unless biopsy proven benign) 8. lobular features on histology (pure or mixed) or sarcoma histology 9. node positive on axillary dissection or in the sentinel lymph node biopsy; 10. extensive in situ carcinoma (eic) 11. multicentric or multifocal disease 12. paget's disease of the nipple 13. distant metastases 14. lumpectomy cavity not well visualized on accuboost imaging 15. lumpectomy cavity with 1cm margin (ptv) not adequately encompassed by any applicator (ptv \> 6cm) 16. breast separation with compression \> 7cm. 17. overlap of skin between orthogonal treatment axes.

Keywords: invasive ductal cancer tubular breast cancer breast cancer colloid er positive radiation
a phaseⅰ comparative study to evaluate the pharmacokinetics of ql2108 to dupixent®

Conditions: Atopic Dermatitis

Summary: it is a randomized, double-blinded, parallel, single-dose, phaseⅰcomparative study to evaluate the pharmacokinetics and safety of ql2108 to dupixent® in healthy chinese adult subjects. a total of 198 healthy subjects are planned to be included and randomized at a ratio of 1:1 to receive single 300mg/2.0ml ql2108 injection or dupixent®.

the study has a screening period of 28 days. pk blood samples will be collected from subjects to determine the serum concentration of dupilumab, thus to evaluate the similarity of the pharmacokinetics of the two study drugs. the investigator will perform safety evaluation for vital signs, physical examinations, ecg, clinical laboratory tests and adverse events throughout the study. immunogenicity evaluation (ada, ada titration and nab) will also be evaluated.

Eligibility criteria:
inclusion criteria: * chinese healthy subjects aged from 18 to 50 years (including the boundary value) * normal vital signs, physical examinations, ecg, clinical laboratory tests and imageological examination results or abnormal with no clinical significance according to the doctor's judgment; * body weight between 50-90kg and bmi between 19.0-26.0kg/m2 (including boundary value); exclusion criteria: * people who have previously used or participated in clinical trials of monoclonal antibody with the same target or dupilumab * people with a clear history of allergy and/or allergy to monoclonal antibodies of the same target /investigational drugs and their components. * people who have special dietary requirements or are unable to follow a uniform diet. * dizzy blood, dizzy needle history. blood donation \> 400 ml within 3 months or \> 200 ml within 4 weeks prior to screening, or planning to donate blood during the study. * having participated in drug or device clinical trials within 3 months or 5 half-lives of other investigational drugs before the study administration.

Keywords: atopic dermatitis