Kornimate/medical-research-clean huggingface dataset:
moxibustion for primary dysmenorrhea

Conditions: Primary Dysmenorrhea

Summary: hypothesis: moxibustion is effective for managing primary dysmenorrhea. aim: to attest the effectiveness and safety of moxibustion for primary dysmenorrhea. design: a randomized controlled trial. 152 participants will be included. two arms: moxibustion treatment group and ibuprofen control group.

there is no convincing evidence for the efficacy of moxibustion for primary dysmenorrhea, due to low methodologic quality and small sample size. the investigators designed the random clinical trial to investigates the effectiveness of moxibustion in treating primary dysmenorrhea, the purpose of this study is to provide the research base of moxibustion efficacy. the investigators also examined the acceptability and any adverse effects associated with the use of moxibustion.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of guidelines of primary dysmenorrhea clinical by the society of obstetricians and gynaecologists of canada * menstrual cycle is regular (28±7) days * syndrome differentiation of traditional chinese medicine: congealing cold-damp and qi-stagnation and blood stasis * mean value of ≥40mm during last 3 months * informed consent form must be signed by patient or lineal relative exclusion criteria: * patients with secondary dysmenorrhea, which is caused by endometriosis, pelvic inflammation, myoma of uterus and so on * patients who are unconscious and psychotic * patients with serious primary illness or diseases of cardiovascular, liver, renal, gastrointestinal, hematological systems and so on * patients take prostaglandin synthetase inhibitors (pgsi) 2 weeks before inclusion * pregnant women or women in lactation

Keywords: moxibustion primary dysmenorrhea
developing and validating clinical efficacy for obesity digital cbt model

Conditions: Search MeSH

Summary: the aim of the present study is to develop and validate the effects of a new cognitive behavioral therapy (cbt) using digital healthcare mobile apps such as noom coach and inbody.

seventy female participants whose bmi scores were above 23 and who had no other clinical problem except obesity were randomized into an experimental and a control group. forty-five people in the experimental group were connected with the therapist using digital healthcare apps, so they got daily feedbacks and assignments for 8 weeks. twenty-five people in the control group also used digital healthcare apps but they were asked to do self-care without intervention.

Eligibility criteria:
inclusion criteria: * sims score ranks over high 20% of total exclusion criteria: * had been prescribed with psychological problems or medical problems.

Keywords: obesity cognitive behavioral therapy
safety and efficacy study of etanercept (enbrel®) in children with systemic onset juvenile rheumatoid arthritis

Conditions: Juvenile Rheumatoid Arthritis

Summary: the primary objective of this study was to determine the efficacy of etanercept in pediatric patients with systemically active system onset juvenile rheumatoid arthritis (sojra).

participants were to receive etanercept at a dose of 0.4 mg/kg twice weekly in part 1a. participants who had a partial response (not able to reduce prednisone dose by 50% of the baseline dose in 5 months) while on 0.4 mg/kg twice weekly etanercept in part 1a were to enter part 1b for up to 4 months and were to have the dose of etanercept increased to 0.8 mg/kg twice weekly. participants who did not meet the response criteria in part 1a or part 1b of the study were to be withdrawn from the study as non-responders. participants who responded in either part 1a or part 1b were randomized into part 2, where they received etanercept or matching placebo in a double-blind manner twice weekly for up to 3 months. in part 2, participants were stratified by the dosage of etanercept (0.4 mg/kg or 0.8 mg/kg) they were receiving in part 1a or part 1b. participants could enter part 3, the open-label re-treatment portion of the study, only if they had been entered into part 2 of the study and had either flared in part 2 or had completed 3 months of treatment in part 2. the maximum time participants could receive etanercept in part 2 and part 3 combined was 12 months.

Eligibility criteria:
inclusion criteria: * 2 - 18 years of age * sojra for at least 3 months, with stable systemic features * if taking methotrexate, hydroxychloroquine, or nsaids, dose must be stable * must take prednisone at a stable dose exclusion criteria: * need for other dmards or prestudy requirements for oral or parenteral pulse steroids or intra-articular steroids * pregnant or nursing female * clinically significant abnormal laboratory test results for blood cells, liver or kidney function, or serology * previous receipt of any tumor necrosis factor (tnf) inhibitor * live virus vaccine within 12 weeks of study entry * participation in another study requiring informed consent within 12 weeks of entry * diabetes that requires insulin treatment * infection, chronic, recurrent, or currently active * any serious medical or psychiatric condition or history of alcohol or drug abuse

Keywords: systemic onset juvenile rheumatoid arthritis sojra fever rash joint pain
does first oral intake after emergence predict the incidence of post-operative vomiting in children?

Conditions: Post-operative Vomiting

Summary: second only to pain, nausea and vomiting are the most uncomfortable complications of surgery and anesthesia. unfortunately, our best defense against post-operative nausea and vomiting, a medicine called ondansetron (zofran), is in dire national shortage. consequently, non-pharmacological methods of prevention and treatment for post-operative nausea and vomiting have increased import. following emergence from general anesthesia, children often request food and drink. there have been no studies to date that definitively determine the optimal first food or drink choice for these children. this study proposes to randomize children to either water or juice first intake following surgery. the investigators expect to find that children who consume glucose are less likely to vomit than those who first receive water.


Eligibility criteria:
inclusion criteria: * dental surgery * tonsillectomy and adenoidectomy * strabismus surgery * age 2-18 exclusion criteria: * patient refusal * parent refusal * allergy / contraindication to ondansetron * prone to vomiting * inpatient * preoperative anxiolysis with ketamine * recovery location other than pacu * nil per os at baseline * presence of enteric tube * contraindication to any part of the study protocol

Keywords: post-operative vomiting
turkish validity and reliability study of virtual reality sickness questionnaire

Conditions: Sickness Behavior

Summary: this study is planned for the cultural adaptation and validity of the "virtual reality sickness questionnaire".

virtual reality (sg) creates a virtual environment that reflects a real environment and offers various experiences to users. motion sickness can be observed in people after using virtual reality applications or simulation devices in education. there are questionnaires in the literature such as "simulator sickness questionnaire" and "motion sickness questionnaire". however, these questionnaires are specific surveys to evaluate symptoms that develop after vehicle handling or use of simulation devices for pilot training, while they are not ideal questionnaires to evaluate symptoms that may develop after virtual reality applications. because there are important differences between virtual reality systems and simulation systems in terms of the appearance of motion disturbance symptoms. for this reason, "virtual reality sickness questionnaire" has been developed that can evaluate these symptoms. there is no turkish version of the "virtual reality sickness questionnaire" in the literature. for this reason, this study is planned for the cultural adaptation and validity of the "virtual reality sickness questionnaire".

Eligibility criteria:
inclusion criteria: * not having mental - cognitive problems, * being a volunteer exclusion criteria: * oculomotor and vestibular disease * cardiovascular, neurological and gastrointestinal problems

Keywords: virtual reality sickness validity reliability turkish
safety study of 90y-hmn14 to treat colorectal cancer

Conditions: Colorectal Cancer; Colon Cancer; Rectal Cancer; Colorectal Neoplasms; Colorectal Carcinoma; Colorectal Tumor

Summary: the purpose of this trial is to determine the safety of 90y-hmn14 at different dose levels in the treatment of colorectal cancer.


Eligibility criteria:
disease characteristics: * patients with a documented histologic or cytologic diagnosis of a colonic or rectal malignancy. * patients with recurrent, advanced and/or metastatic disease, who have either failed standard therapy or are not eligible for any alternate therapies of higher therapeutic priority. * patients with at least one identified (confirmed) and measurable tumor site\* with no tumor site \> 5 cm in the greatest dimension. prior/concurrent therapy: * surgery: patients are excluded if they have had major surgery either during or within four weeks prior to study entry. * chemotherapy: patients must have failed standard therapy or are not eligible for any alternate therapies of higher therapeutic priority. patients must have completed chemotherapeutic agents four weeks prior to study entry. * biologic therapy: patients who have received a chimeric, cdr-grafted (humanized), or human igg will be eligible provided pre-study evaluations demonstrate no significant reactivity with hmn-14 igg (i.e., haha). * radiotherapy: no prior radiotherapy within four weeks of study entry. no prior external beam irradiation to a field that includes more than 30% of the red marrow. no prior radiation to maximal tolerable levels for any critical organ (e.g., 3,000 cgy for the liver, and 2,000 cgy for the lungs and kidneys). patients who have had standard pelvic field radiation as adjuvant therapy for rectal carcinoma will be eligible only after the mtd is established. * other: any experimental therapy (i.e., drugs, biologicals, procedures) for the primary malignancy, either during or within four weeks prior to study entry. patient characteristics/inclusion criteria: * age range: male or female at least 18 years of age * performance status: patients with a karnofsky performance status \> 70% (or equivalent, ecog 0-1) and expected survival of at least 3 months. * hematopoietic: hemoglobin \> 10 g/dl; wbc \> 3000 per mm3; granulocyte count \> 1,500 per mm3; platelet count \> 100,000 per mm3 * hepatic: total bilirubin \< 1.5 times the institutional upper limit of normal (iuln)ast or alt \< 2 x iuln * renal: creatinine \< iuln * cardiovascular: patients with lvef \>/= 50% by required muga/2d-echo study. * pulmonary: patients with dfco and fev1 \>/= 60% by required pulmonary function tests. * other: patients who have had a prior imaging study with a murine monoclonal antibody may be included. patients agreeing to use a medically effective method of contraception during and for a period of three months after the treatment period. a pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the study. patients able to understand and give written informed consent.

Keywords: colon cancer rectal cancer colorectal neoplasms colorectal carcinoma colorectal tumor
hmp for addictions study

Conditions: Opioid Use Disorder; Opioid Use; Buprenorphine Dependence

Summary: the goal of this clinical trial is to see whether the healthy minds program for addictions could be used to help veterans with moderate-severe opioid use disorder and post-traumatic stress disorder stay on buprenorphine maintenance treatment. participants will be asked to complete a six-week program consisting of 6 weekly, 2-hour in-person group sessions, as well as assessments before the start of the sessions.

this is a 6-week, single-arm, single-center pilot study of the acceptability and efficacy of an adaptation of the healthy minds program for veterans with opioid use disorder on buprenorphine maintenance treatment. following the screening visit, eligible subjects will complete 6 in-person sessions over the course of 2 months. the first session will be an introductory session introducing the basics of the program. after the introductory session, there will be four weekly sessions, each dedicated to a different domain of the program - awareness, connection, insight, and purpose. participants will be encouraged to practice daily anywhere from 5 to 30 minutes from a set of practices that will be available to them on a password protected website. the intervention will end with a closing session where participants will have the opportunity to reflect on their experience of the program and share feedback. weekly sessions will be held in person and will be facilitated by an md, phd psychiatrist and neuroscientist with 8 years of mindfulness practice together with a certified peer support specialist.

Eligibility criteria:
inclusion criteria: * individuals at least 18 years of age * english-speaking * veterans * ability to understand and willingness to sign a written informed consent document * have access to a smartphone, tablet, or computer with internet connection to access recordings for home practice * ability and willingness to attend all 6 session of the study, and to complete all assessment questionnaires * verified post-traumatic stress disorder (ptsd) according to dsm-5 criteria * on buprenorphine maintenance treatment for opioid use disorder (oud) for a minimum of 3 months exclusion criteria: * regular daily meditation practice for past 6 months or regular weekly meditation practice for past 12 months * attended a meditation retreat or a yoga/body practice retreat with a significant meditation component * previous use of healthy minds program app * current suicidal intent and/or high self-injury risk, as determined from the interview * current psychopathology that interferes with study participation as assessed by interview
effectiveness of bupivacaine, ketorolac, ketamine, vs bupivacaine alone in reducing postoperative pocket pain

Conditions: Pain Management

Summary: bupivacaine is the most widely used local anesthetic agent across majority of the cardiac implantable electronic device (cied) implant procedures in the united states. it is hypothesized that the combination of bupivacaine-ketorolac-ketamine (bkk) is more effective in alleviating perioperative and postoperative pain as compared to the use of bupivacaine alone. a few studies have been done to look for the effectiveness of bkk in abdominal surgical procedures. however, no study has been done to evaluate its efficacy and effectiveness in patients undergoing cied insertion.

bupivacaine is a widely used local anesthetic and is often administered by spinal injection prior to major surgical procedures. ketorolac is a potent nsaid which is used for the short-term relief of moderate to severe pain. it's used for long term duration is generally limited due to its potential to cause gi ulcers/perforation and renal failure. a single dose of perioperative ketorolac has been found to be effective in reducing opioid consumption. ketamine is nmda receptor antagonist and is used for its anesthetic, analgesic, and psychotomimetic effects. it is primarily used for induction and maintenance of anesthesia and induces a trance like state providing pain relief, sedation, and amnesia. although an effective local anesthetic agent, bupivacaine has weak analgesic effect and is used in combination with several analgesic agents for effective perioperative and postoperative analgesia. a common drug used in this analgesic regimen usually includes opioids such as morphine, oxycodone, and fentanyl. over the last few decades the united states has witnessed an opioid epidemic and post-surgical opioid prescription is one of the major contributors of this epidemic. an opioid free combination of bupivacaine-ketorolac-ketamine (bkk) is thought to be effective in alleviating perioperative and postoperative pain.

Eligibility criteria:
inclusion criteria: * both male and female patients * patients older than 18 years of age * patients undergoing new cied (icd, pacemaker, crt-d or crt-p) * patients willing to participate in the study exclusion criteria: * patients with prior history of allergic reaction to any component of the drug; bupivacaine, ketorolac, or ketamine * pregnant or breastfeeding patients * prisoners * patients younger than 18 years of age * patients not willing to participate in the study * patients deemed not suitable or unstable for the study as per physician's discretion
open label study of the effects of secukinumab on nail psoriasis and non-invasive measures of enthesitis (phase iv)

Conditions: Psoriasis

Summary: this study will be an open label study of secukinumab for the treatment of nail psoriasis. secukinumab is an fda-approved treatment for psoriasis. we will examine time to response and different methods of defining nail disease response.

this study will be an open label study of secukinumab for the treatment of nail psoriasis. secukinumab is an fda-approved treatment for psoriasis. this is a single arm trial - all patients will receive the study drug. we will examine time to response and different methods of defining nail disease response.

Eligibility criteria:
inclusion criteria: * active psoriatic nail disease defined as a minimum 4 or more fingernails or napsi\>20 * active skin psoriasis currently (no minimum pasi or bsa) or skin psoriasis in the past documented by a dermatologist * age 18-85 exclusion criteria: * history of il-17 inhibitor use (other therapies including tnf inhibitors or non- biologics dmards in the past are acceptable) * inflammatory bowel disease * metal implants or other concerns for use of mri * active infection * patients may have a history of self-reported psoriatic arthritis but may not have active psa at the time of screening. * we will exclude patients with onychomyosis of the fingernails on clippings

Keywords: psoriasis
risk of air contamination during visceral surgery in covid19 patients

Conditions: Sars-CoV2; Surgery; COVID

Summary: sars-cov2 has been found in the digestive tract, as well as the respiratory tract. protection of health care workers during surgery has been increased and some guidelines advocate for abandoning laparoscopy in covid19 patients for fear of contamination, evenghtough this does not benefit the patient. however, sars-cov2 contamination risk during visceral surgery remains unknown. inadequate protection is unnecessary costful and can be inefficient if too binding. our hypotheses are that 1) sars-cov 2 can travel through droplet and air during visceral surgery. 2) laparoscopy, because of the pneumoperitoneum and its leaks, warrant more air contamination whereas laparotomy warrant more droplet contamination, which would justified increased protection.


Eligibility criteria:
inclusion criteria: * documented sars-cov2 infection (nasopharyngeal swab, tracheal sampling, thoracic ct, serology) * need of visceral surgery (laparoscopy or laparotomy) * signed informed consent * social coverage * patient who agrees to be included in the study and who signs the informed consent form * patient affiliated to a healthcare insurance plan * patient willing to comply with study's requirements exclusion criteria: * need of another type of surgery during the same procedure * mentally unbalanced patients, under supervision or guardianship * patient who does not understand french/ is unable to give consent * patient not affiliated to a french or european healthcare insurance * patient incarcerated

Keywords: covid-19 visceral surgery air contamination laparoscopy, prevention prevention
agn-242428 in the treatment of plaque psoriasis

Conditions: Plaque Psoriasis

Summary: the purpose of this study is to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of 3 doses of agn-242428 in adult participants with moderate to severe plaque-type psoriasis.


Eligibility criteria:
inclusion criteria: * participants who have a confirmed diagnosis of plaque psoriasis, diagnosed at least 6 months before study with a physician's global assessment (pga) score ≥ 3 at screening and baseline * severity of disease must be at least moderate, defined as psoriasis area and severity index (pasi) ≥ 12 and % body surface area (bsa) ≥ 10 * participant is a candidate for phototherapy or systemic therapy for psoriasis * body weight of at least 55 kilograms (kg) (121 (pound) lbs) exclusion criteria: * non-plaque forms of psoriasis (erythrodermic, guttate, pustular) or drug-induced psoriasis * psoriasis which has not been stable for the 4 weeks prior to screening and which is unstable at study day 1 * history of gilbert's, rotor, or dubin-johnson syndromes or any other disorder of bilirubin metabolism * history of active mycobacterium tuberculosis (tb) infection or untreated or inadequately treated latent tb * positive quantiferon test for tb infection at screening * had a vaccination with bacillus calmette-guérin (bcg) within 12 months prior to baseline * positive drug and/or alcohol test at screening (with the exception of marijuana). retesting in the case of a positive alcohol test is allowed at the discretion of the sponsor * current treatment or history of treatment with any anti-tumor necrosis factor alpha (tnfα) biologic therapy within 3 months or 5 half-lives of study, and/or all other biologics within 6 months of study (day 1) * efficacy failure on 2 or more biologic agents for the treatment of psoriasis when the failures occurred within 1 year of the initiation of the therapy of the first biologic agent * alanine aminotransferase (alt), aspartate aminotransferase (ast) or total bilirubin (tbl) exceeding 1.5 times the upper limit of normal (uln) at screening.
exposure therapy for veterans with ptsd and panic attacks (phase 1)

Conditions: PTSD; Panic Attacks

Summary: to evaluate the feasibility, acceptability and effectiveness of multiple channel exposure therapy-veterans (mcet-v) as a treatment for returning service members with comorbid posttraumatic stress disorder (ptsd) and panic disorder (pd) in two phases. the first phase of the study will examine the feasibility and acceptability of mcet-v.

with the increasing number of operations iraqi freedom and enduring freedom (oif/oef) veterans returning from war-zone areas, many will experience anxiety disorders such as ptsd and comorbid problems. currently, about one in every six oif/oef veterans experiences ptsd and co-occurring pd. although effective treatments exist for treating one or the other, we do not yet have treatments that can simultaneously target ptsd and pd. thus, recent attention has focused on the development of multi-component treatments that simultaneously address ptsd and pd. this study is the first systematic investigation of a time-limited, multi-component cognitive-behavioral treatment for veterans with specific comorbid anxiety problems. the purpose of the first phase of the study is to evaluate the feasibility and acceptability of the multi-component cognitive-behavioral treatment in an open trial.

Eligibility criteria:
inclusion criteria: * being a veteran of any era; * being enrolled in the trauma recovery program (trp) at the michael e. debakey veterans affairs medical center (medvamc), with a current diagnosis of ptsd and pd; * being stable on psychotropic medication for 4 weeks before study participation; and * being at least 18 years of age. exclusion criteria: * active substance dependence, or bipolar or psychotic disorders; * severe depression and active suicidal ideation and intent (based on structured clinical interview for dsm-iv disorders \[scid-iv\] \& beck depression inventory-2nd edition \[bdi-ii\]); * cognitive impairment as indicated by the st. louis university mental status exam (slums); and * veterans currently receiving psychosocial treatment specifically targeting ptsd or panic symptoms.