Kornimate/medical-research-clean huggingface dataset:
coping with pain through hypnosis, mindfulness and spirituality

Conditions: Pain, Acute

Summary: the purpose of this study is to evaluate and compare the immediate effects of self-hypnosis, mindfulness meditation and a spiritual intervention relative to a control condition for increasing pain tolerance and reducing pain intensity and pain-related stress, in response to experimental painful stimulation.

the primary aim of this study (aim 1) is to compare the immediate effects of self-hypnosis (sh), mindfulness meditation (mm), and christian meditation (cm), relative to a control group (cn), for increasing pain tolerance and reducing pain intensity and pain-related stress, in response to experimental painful stimulation in a sample of healthy volunteers. an exploratory aim of this study (aim 2) is to identify possible shared and unique predictors of response to the three treatment conditions. the possible predictors we plan to test include sex, age, religious affiliation, hypnotic suggestibility, baseline mindfulness, acceptance, pain-related beliefs, religiosity, trait spirituality, previous experience with sh, mm and cp, outcome expectancies, and trait absorption. this is a randomized quantitative experimental mixed-model repeated-measures study with three assessment points: baseline (t0), pre-test (t1), and post-test (t2). eligible healthy adults will be randomized to one of the four study conditions. interventions will be a 20-minutes audio-guided practice of either self-hypnosis, mindfulness meditation, or christian prayer. participants in the control group will not be instructed to use any specific strategy during the painful stimulation. participants will be submitted to a first cycle of cold pressor arm wrap. they will then listen to a 20-minutes audio recording inducing one of the three interventions, or, in the case of the control group, to a 20-minutes recording of a natural history textbook. primary outcomes are pain intensity, pain tolerance, and pain-related stress as measured by salivary cortisol level and heart rate variability.

Eligibility criteria:
inclusion criteria: * 18 years old or older; * able to read, speak and understand portuguese; * willing to be randomly assigned to all four conditions (regardless of participant's own religious affiliation) exclusion criteria: * reporting history of musculoskeletal problems, cancer, heart disease, stroke, epilepsy, diabetes, or raynaud syndrome; * having an open wound, cut, or fracture in any of the upper limbs; * self-reported alcohol or substance dependence; * cognitive or physical impairment, or severe psychopathology that could prevent participation.

Keywords: experimental pain self-hypnosis mindfulness meditation christian prayer
subcutaneous golimumab (glm) plus dmards for rheumatoid arthritis, followed by intravenous/subcutaneous glm strategy (p06129 am2)

Conditions: Arthritis, Rheumatoid

Summary: part 1 of this trial will assess the safety and effectiveness of subcutaneous (sc) golimumab administered by autoinjector once monthly, when combined with different disease-modifying antirheumatic drug (dmard) regimens used in daily rheumatology practice. subsequently, part 2 will study if a strategy of intravenous (iv) golimumab to induce remission followed by sc golimumab to retain remission is superior to continuing a sc regimen.

participants who had a good or moderate european league against rheumatism (eular) response but not achieve remission at the end of part 1 were invited to participate in part 2 and were randomized to either intravenous golimumab (iv glm) + subcutaneous golimumab (sc glm) or sc glm alone.

Eligibility criteria:
inclusion criteria: for part 1: * age \>=18 years, either sex, any race. * diagnosis of ra according to the 1987 revised american college of rheumatology (acr) criteria. * active disease despite dmard treatment * subject must be taking at least one of the allowed dmards, and must be able to continue with it during the trial. * eligibility for anti tumor necrosis factor (tnf) use according to the following criteria: * participant must have failed conventional treatment according to the investigator's opinion or local guidelines. * local guidelines regarding safety screening of anti tnf candidates (ie, tuberculosis \[tb\] screening and other safety screening such as vaccination, if applicable) must be met. chest x-ray and either a ppd skin test or quantiferon®-tb gold test are also required. * anamnesis and physical examination must make the participant eligible for anti tnf use and trial participation according to the investigator's judgment. for part 2: * participant must have completed part 1 of this trial. * participant must have: * good or moderate response to sc golimumab at the end of month 6 compared to baseline, and. * no das28 esr remission. * both the investigator and the subject must agree to switch the participant's treatment to iv administration as may be required in part 2 of this trial. * the investigator must judge that no safety events (eg, serious adverse events \[saes\], serious infections, marked injection-site reactions or intolerance to drug) have occurred that could reoccur or aggravate with increased drug exposure. exclusion criteria: * history of biologic drug use for ra. * evidence of active tb. or latent tb that is untreated. * moderate to severe heart failure * certain inflammatory rheumatic disease other than ra or certain systemic inflammatory condition * allergy to latex
pilot study for veinoplus to improve symptoms of postthrombotic syndrome (pts)

Conditions: Post Thrombotic Syndrome; Deep Vein Thrombosis; Venous Stasis Syndrome; Venous Insufficiency; Postphlebitic Syndrome

Summary: the investigators plan to perform an exploratory study to investigate the effects of electro-stimulation of the legs on the symptoms and clinical findings of post thrombotic syndrome (pts), as well as quality of life of patients with pts. the investigators theorize that electro-stimulation will provide both a mechanical benefit via muscular contraction and increased venous outflow from the affected extremity, as well as an anesthetic effect, which the investigators anticipate will translate into improved symptomatic outcomes, quality of life (qol) benefits.

the purpose of this study is to determine the optimal electrical stimulation intensity level at which subjects using the portable electrical muscle stimulator (veinoplus) have the largest benefit for relief of post thrombotic symptoms. to determine if the subjects reported benefit from the device and willingness to continue using the device. subjects will be pre-screened on the phone for eligibility, and an initial appointment will be set. the subject will be given a device and complete a quality of life survey. the subject will also be assessed on the villalta scale. after two months, the subjects will return for the final visit where the villalta scale and quality of life survey will be reassessed, and the device taken back.

Eligibility criteria:
inclusion criteria: * age \>18 * presence of previously objectively documented unilateral, lower extremity deep venous thrombosis * presence of pts (typical pain and swelling - worse after standing and vertical activity and relieved by rest and the horizontal position), severe enough that the patient is interested to explore a treatment option that might improve these symptoms. symptoms had to have been stable for ≥ 3 months. unstable symptoms are defined as: worsening, improving or variable symptoms over preceding months. * subjects must be willing and able to give written informed consent. exclusion criteria: * inability or refusal to provide informed consent * pregnancy * women of child bearing potential (wocbp) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period * geographic inaccessibility to prevent scheduled return evaluations * incapable of responding to questionnaires * expected lifespan \<6 months * presence of cardiac pacemaker * history of cardiac arrhythmia * presence of infected, or inflamed areas or skin eruptions; phlebitis, thrombophlebitis, active venous ulceration * history of seizures

Keywords: veinoplus post thrombotic syndrome deep vein thrombosis electrical muscle stimulator venous stasis syndrome venous insufficiency syndrome postphlebitic syndrome history of deep vein thrombosis
ambulatory versus inpatient initiation of home mechanical ventilation

Conditions: Amyotrophic Lateral Sclerosis

Summary: the purpose of this investigation is to see if outpatient initiation of noninvasive home mechanical ventilation combined with closed telemonitoring and follow-up in patients with amyotrophic lateral sclerosis is non-inferior to initiation during admission to the hospital the primary hypothesis is that outpatient intiation of noninvasive home mechanical ventilation combined with closed telemonitoring and follow-up is non-inferior to initiation during hospitalization in patients with amyotrophic lateral sclerosis.


Eligibility criteria:
inclusion criteria: * age \> 18 years * diagnosed with amyotrophic lateral sclerosis * indication for start of non-invasive mechanical ventilation exclusion criteria: * no informed consent * does not understand danish or english * indication for invasive mechanical ventilation * no morning baseline pco2 * hospitalization
neoadjuvant mfolfoxiri chemotherapy alone for extramural vascular invasion positive locally advanced rectal cancer

Conditions: Locally Advanced Rectal Cancer

Summary: extramural vascular invasion positive(emvi+) is a high risk of distant metastasis for locally advanced rectal cancer(larc) after resection. the study is to evaluate the efficacy and safety of mfolfoxiri as neoadjuvant chemotherapy alone for emvi+ larc.

it is an investigator-initiated, single institution, prospective, single-arm clinical study to evaluate the efficacy and safety of folfoxiri as neoadjuvant chemotherapy alone for emvi+ larc.patients of larc with emvi+ evaluated by pelvic magnetic resonance imaging (mri) were enrolled in this trial. all emvi+ larc will receive the study regimen every 2 weeks for 6 cycles. mri will be performed after 3 cycles of chemotherapy to assess clinical response.mri was performed to assess clinical response after chemotherapy. patients with mesorectal fascia-positive or yct4a/b after re-evaluation would receive radiation before surgery, whereas responders would have immediate total mesorectal excision (tme).if the tumor response is good enough(partial response or complete response), the patient will receive another 3 cycles of folfoxiri then surgery. on the contrary, if the tumor shows poor response(stable disease or progressive disease) or with mesorectal fascia-positive or yct4a/b after re-evaluation, radiotherapy will be performed combined with capecitabine before operation. all patients will receive 6 cycles of mfolfox6 or 4 cycles xelox as adjuvant chemotherapy after tme.

Eligibility criteria:
inclusion criteria: 1. aged ≥ 18 to 75 years at diagnosis; 2. ecog status 0 or 1; 3. signed informed consent; able to comply with study and/or follow- up procedures; 4. diagnosis of rectal adenocarcinoma; 5. distal border of the tumor must be located \< 12 cm from the anal verge; 6. mri examination diagnosed emvi-positive; 7. tumor amenable to curative resection; 8. adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment: (1) neutrophilic granulocytes ≥ 3.0 x10\^9/l, platelet count ≥ 75 x 10\^9/l, hemoglobin (hb) ≥ 90g/l; (2) bilirubin ≤1.5 x the upper limit of normal (uln),alanine aminotransferase (alt)/aspartate aminotransferase (ast) ≤ 2.5 x uln; (3) serum creatinine ≤ 1.5 x uln. 9. no renal disease that would preclude study treatment or follow-up exclusion criteria: 1. hypersensitivity to fluorouracil, oxaliplatin or irinotecan; 2. patient had received pelvic radiotherapy; 3. patient had received systemic chemotherapy; 4. history of invasive colon or rectal malignancy, regardless of disease-free interval; 5. had metastatic disease; 6. patient had second malignant disease within 5 years; 7. uncontrolled co-morbid illnesses or other concurrent disease; 8. patients refused to signed informed consent. 9. pregnant and nursing women;

Keywords: extramural vascular invasion neoadjuvant chemotherapy mfolfoxiri
safety and tolerability of single and multiple doses of vak694 in healthy and atopic subjects

Conditions: Allergic Rhinitis

Summary: this study will evaluate the safety and tolerability of single and multiple doses of vak694 in healthy volunteers and otherwise healthy volunteers with a history of allergies.


Eligibility criteria:
inclusion criteria: * history of allergic rhinitis (part 2 only) exclusion criteria: * very low or high body weight * heavy or recent smoker * exposure to human monoclonal antibodies other protocol-defined inclusion/exclusion criteria may apply.

Keywords: allergic rhinitis, anti-interleukin 4
comparison and modification in neointimal pattern assessed by optical coherence tomography with high versus moderate efficacy statin treatment after drug eluting stent implantation: compass trial

Conditions: Coronary Artery Disease

Summary: this study is a prospective randomized trial to evaluate and compare the quantitative and qualitative characteristics of neointimal formation between high and low efficacy statin treatment after drug eluting stent (des) implantation, in patients with homogeneous or heterogeneous neointimal pattern accessed by optical coherence tomography (oct). the investigators postulate that high efficacy statin could have superior effect on modification of neointimal pattern, compared with lower efficacy statin. our main hypothesis is that atorvastatin 40mg, high efficacy statin might have superior effect on modification of neointimal pattern evaluated by serially followed oct, compared with pravastatin 20mg in patients with des implantation.


Eligibility criteria:
inclusion criteria: * patient is ≥ 20 years old * patients who received oct related to clinical needs or the end point of other study * patients who received des within 1 year before oct evaluation * patients with homogenous or hetero neointimal pattern by oct * non-statin user and moderate or low efficacy statin user exclusion criteria: * refuse to participate * contraindication to statin treatment * women with current or potential childbearing * life expectancy \<1 year * high efficacy statin user (atorvastatin 80mg or rosuvastatin 20mg)
prevalence of secondary hypogonadism in male patients on chronic opioid therapy for cancer-related pain syndromes

Conditions: Advanced Cancer; Hypogonadism; Pain

Summary: primary objective: 1. to determine the prevalence of secondary hypogonadism in male patients on chronic opioid therapy for cancer-related pain syndromes. secondary objective: 1. to determine the degree of sexual dysfunction, fatigue, and depression prevalent in male patients on chronic opioid therapy for cancer-related pain syndromes.

studies have shown that non-cancer patients taking opioid pain medication for a long period of time can have decreased libido and decreased sexual function. individuals may be asked to take part in this study even if they have not taken opioid pain medications in the last twelve months. these individuals would also be enrolled to learn if long-term treatment of cancer-related pain with opioid medications results in decreased sex hormones, decreased sex drive, and increased fatigue or depression. participants in this study will be asked to complete a set of questions about their sexual functions, physical symptoms, and psychological symptoms such as fatigue and depression. it will take about 25 minutes to complete the questionnaires. participants will have blood drawn (about 2 teaspoons of blood) to test their sex hormone level. participants who are identified as having low sex hormone level (hypogonadism) will be referred to an endocrinologist for standard hormone replacement therapy. this is a one-time evaluation, no follow-up visit or questionnaires are required. this is an investigational study. a total of 108 individuals will take part in this study. all will be enrolled at utmdacc.

Eligibility criteria:
inclusion criteria: 1. chronic pain greater than one year. 2. male. 3. cancer status must be stable or in remission. for this study, "stable disease" is defined as identifiable disease at local or metastatic sites that has shown no progression over the previous 3 months and there has been no cancer treatment for ³ 3 months. 4. patients must be on chronic opioid therapy on a continuous basis in the preceding twelve months with a morphine equivalent daily dose (medd) ³ 200. 5. age \>/= 18. the questionnaires used in this study have been validated only in the adult population. in addition, some of the questionnaires contain questions of a sensitive nature and are not appropriate in the pediatric population. 6. patients must be able to understand and sign the consent form. exclusion criteria: 1. patient who refuses to participate in the study or determined incapable of completing the research. 2. patients with pre-existing hypopituitarism. causes include certain tumors (pituitary adenomas, hypothalamic tumors), inflammatory diseases (granulomatous diseases), vascular diseases (postpartum necrosis, carotid aneurysm), traumatic/destructive events (prior surgery, trauma, or radiation), developmental anomalies, infiltration. 3. patients who tare taking any drugs that may affect the hypothalamic-pituitary-gonadal axis.

Keywords: advanced cancer chronic opioid therapy secondary hypogonadism cancer-related pain syndromes questionnaire
evaluation of neurologic and psychiatric adverse events of several antiretroviral drugs in real life setting

Conditions: HIV

Summary: the frequency of neurological and psychiatric complaints for participants taking rilpivirine, elvitegravir, or dolutegravir reaches on average 20-30% during clinical trials. the inclusion and exclusion criteria for enrolling people living with hiv are at times so selective and the subsequent descriptions of minor or severe adverse events (ae's) so often imprecise and ambiguous that one cannot extrapolate these particular research results to practicing medicine. these adverse events negatively affect the patient's quality of life and ultimately his or her good adherence to treatments. this study aims at assessing the prevalence and at describing the neurological and psychiatric adverse events related to these drugs.


Eligibility criteria:
inclusion criteria: * hiv infection * age \> 18 * treatment with rilpivirine, elvitegravir, or dolutegravir (for exposed patients) * treatment with none of these drugs (for non exposed patients) * capacity of reading french language exclusion criteria: * drugs addiction (except for amyl nitriles ("poppers") and cannabis) * alcoholism * co-infection with hepatitis c virus * pregnant or breast feeding patient
correlation between daily physical activity and disability, fatigue, cognition and quality of life in ms patients

Conditions: Relapsing Remitting Multiple Sclerosis; Fatigue; Quality of Life; Physical Activity

Summary: the main purpose of the study is to assess the fatigue, cognition, quality of life and disability correlation to ms-patients daily physical activity.


Eligibility criteria:
inclusion criteria: * rr-ms (relapsing-remitting ms-disease) * age 18-55y * expanded disability status scale (edss) score less than equals to (\<=) 5.5 * not relapse in previous month * other protocol defined inclusion criteria could apply exclusion criteria: * pp-ms (primary progressive disease) * spms (secondary progressive disease) * other protocol defined exclusion criteria could apply.
a study to evaluate long-term safety and clinical activity of givosiran (aln-as1) in patient with acute intermittent porphyria (aip)

Conditions: Acute Intermittent Porphyria

Summary: the purpose of this study is to determine the long-term safety, tolerability and pharmacokinetics of givosiran (aln-as1) in aip patients who completed study aln-as1-001 (nct02452372).


Eligibility criteria:
inclusion criteria: * completed participation in part c of study aln-as1-001 (nct02452372) * not on a scheduled regimen of hemin * women of child bearing potential must have a negative serum pregnancy test, not be nursing, and use acceptable contraception * willing and able to comply with the study requirements and to provide written informed consent exclusion criteria: * clinically significant abnormal laboratory results * received an investigational agent (other than aln-as1) within 90 days before the first dose of study drug or are in follow-up of another clinical study * history of multiple drug allergies or intolerance to subcutaneous injection

Keywords: rnai therapeutic porphyria aip heme/haem arginate
pharmacokinetics of oral calcium carbonate in parturients

Conditions: Pregnancy; Pharmacokinetics; Postpartum Hemorrhage

Summary: this study investigates the time course of change in calcium in the blood after a pregnant subject takes an oral dose of calcium carbonate (commonly marketed as "tums"). this information is important for trials investigating whether calcium can reduce postpartum hemorrhage, bleeding after delivery.


Eligibility criteria:
inclusion criteria: * pregnant female subjects at the study institution, admitted for labor (spontaneous, augmented, or induced) exclusion criteria: 1. severe range blood pressure (bp \>160/\>110) within the 48 hours prior to delivery 2. patient age \ 45 years 3. renal dysfunction with a documented serum cr \> 1.0 mg/dl 4. known history of congenital or acquired cardiac disease or history of arrhythmia 5. patient taking digoxin 6. patient currently taking a calcium channel blocker 7. weight \ 100kg, or 8. receiving magnesium infusion within 24 hours prior to or during cesarean delivery 9. prior or planned administration of calcium by the obstetric or anesthesiology teams for clinical indications within 24 hours of study enrollment 10. patient took a calcium supplement in the past 48 hours 11. patient status is npo (nothing by mouth) as ordered by the clinical team

Keywords: calcium oral calcium calcium carbonate calcium pharmacokinetics pharmacokinetics in pregnancy postpartum hemorrhage ionized calcium pharmacokinetics
use of a novel weight bearing cone beam computed tomography (cbct) scanner for imaging of the patellofemoral joint

Conditions: Patellofemoral Joint

Summary: healthy volunteers will have a weight bearing cone beam ct scan of their knee to assess normal alignment of the knee joint


Eligibility criteria:
inclusion criteria: * willing and able to provide written informed consent * be 16 or more years of age * subject is able to be positioned properly in the investigational device and be still during the exam to reduce the potential of motion during the images exclusion criteria: * have a history of patella instability * have had any type of previous knee surgery * have had a significant fracture of the patellofemoral joint * have a knee ligament injury * are pregnant at the time of screening or become pregnant during the study * have a history of high radiation exposure (i.e., undergone radiation therapy) * non-english speakers