Kornimate/medical-research-clean huggingface dataset:
buprenorphine/naloxone treatment for opioid dependence-experiment ii-1 - 4

Conditions: Heroin Dependence; Opioid-Related Disorders

Summary: the purpose of this study is to assess the abuse liability and examine the reinforcing effects of intravenous buprenorphine and buprenorphine/naloxone combinations in buprenorphine-naloxone maintained volunteers

ongoing study - results not available at this time

Eligibility criteria:
inclusion criteria: individuals must be at least 18 yrs of age, currently opioid dependent and meet fda criteria for narcotic maintenance treatment. co-morbid substance abuse or dependence disorders may also be present. individuals must be healthy despite drug dependency and have a history of iv opioid use. exclusion criteria: individuals with evidence of anti active diagnostic and statistical manual of mental disorders (dsm-iv) axis i psychiatric disorder (e.g. psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.

Keywords: drug dependence
a study to determine the efficacy and safety of lenalidomide in patients with mantle cell nhl who have relapsed or progressed after treatment with bortezomib or are refractory to bortezomib. the "emerge" trial

Conditions: Mantle Cell Lymphoma

Summary: to evaluate the safety and efficacy of lenalidomide (revlimid (r)) in subjects with mantle cell lymphoma who have relapsed, progressed or are refractory to bortezomib.

follow up phase will continue until either 100% of the patients have died, are lost to follow up or have withdrawn consent or a maximum of 4 years from the last patient enrolled, whichever comes first. all other efficacy and safety endpoints will be updated at this time. in the unlikely event that the study will be closed and patients are still responding to treatment at this time, celgene will discuss with the treating physicians options to provide further treatment to the patient after study closure in line with local regulation. follow up for second primary malignancies and os will continue until 100% of the patients have died, are lost to follow up, have withdrawn consent, or a maximum of 5 years from the last patient enrolled, whichever comes first. 10 october 2017: in regard to the last subject last visit date/study completion date, the prolongation of timelines is due to the bridging of a treatment gap for a patient responding to study medication until non-study medication is available.

Eligibility criteria:
inclusion criteria: * biopsy proven mantle cell lymphoma * patients must have documents relapsed, refractory or pd after treatment with bortezomib * must have measureable disease on cross sectional imaging by ct * eastern cooperative oncology group (ecog) performance score 0,1 or 2 * willing to follow pregnancy precautions exclusion criteria: * any of the following laboratory abnormalities * absolute neutrophil count (anc) \< 1,500 cells/mm3 (1.5 x 109/l) * platelet count \< 60,000/mm3 (60 x 109/l) * serum aspartate transaminase/serum glutamic oxaloacetic transaminase(ast/sgot) or alanine transaminase/serum glutamic pyruvic transaminase (alt/sgpt) \> 3.0 x upper limit of normal (uln), except in patients with documented liver involvement by lymphoma. * serum total bilirubin \> 1.5 x uln, except in cases of gilbert's syndrome and documented liver involvement by lymphoma. * calculated creatinine clearance (cockcroft-gault formula) of \< 30 ml /min * patients who are candidates for high dose chemotherapy/allogeneic stem cell transplant are not eligible * history of active central nervous system (cns) lymphoma within the previous 3 months * subjects not willing or unable to take deep vein thrombosis (dvt) prophylaxis * prior history of malignancies, other than mcl, unless the patient has been free of the disease for ≥ 3 years * positive human immunodeficiency virus (hiv) or active hepatitis b or c

Keywords: mantle cell lymphoma non-hodgkin's lymphoma cc-5013 revlimid lenalidomide
prospective registry investigating maternal and infant outcomes in anifrolumab users

Conditions: Systemic Lupus Erythematosus

Summary: primula preg (prospective registry investigating maternal and infant outcomes in anifrolumab users) is a prospective, observational cohort study designed to evaluate the association between anifrolumab exposure during pregnancy and subsequent adverse maternal, fetal, and infant outcomes. this study will fulfil an fda post-marketing requirement.

primula preg (prospective registry investigating maternal and infant outcomes in anifrolumab users) is a us-based, prospective, observational cohort study designed to evaluate the association between anifrolumab exposure during pregnancy and subsequent adverse maternal, fetal, and infant outcomes. the objective of the pregnancy registry is to compare adverse maternal, fetal, and infant outcomes of pregnant individuals with systemic lupus erythematosus (sle) who are exposed to anifrolumab during pregnancy with outcomes in an internal comparison cohort of pregnant individuals with moderate/severe sle who are not exposed to anifrolumab during pregnancy. participation in the registry is voluntary and participants can withdraw their consent to participate at any time. the study is strictly observational; the schedule of office visits and all treatment regimens will be determined by hcps. only data that are documented in patients' medical records during medical care will be actively collected. no additional laboratory tests or hcp assessments will be required as part of this registry. this study will fulfil an fda post-marketing requirement.

Eligibility criteria:
inclusion criteria: exposed cohort 1. currently or recently (within 1 year of pregnancy outcome) pregnant 2. diagnosis of sle 3. consent to participate 4. authorization for their hcp(s) to provide data to the registry 5. exposure to at least 1 dose of anifrolumab at any time during pregnancy unexposed cohort 1. currently or recently pregnant 2. diagnosis of moderate/severe sle 3. consent to participate 4. authorization for their hcp(s) to provide data to the registry 5. exposure to other products for the treatment of moderate/severe sle exclusion criteria: exposed cohort 1. occurrence of pregnancy outcome prior to first contact (for enrollment) with the virtual research coordination center (retrospectively enrolled) 2. exposure to known teratogens and/or investigational medications during pregnancy unexposed cohort 1. occurrence of pregnancy outcome prior to first contact with the virtual research coordination center (retrospectively enrolled) 2. exposure to known teratogens and/or investigational medications during pregnancy

Keywords: chronic autoimmune disease immunosuppressants corticosteroids human monoclonal antibody (igg1ƙ mab) post marketing requirements (pmr) study pregnancy systemic lupus erythematosus
focal thermal therapy acupoint oa knee rct

Conditions: Osteoarthritis, Knee; Randomized Controlled Trial

Summary: osteoarthritis of the knee is a common degenerative joint disorder in our ageing population. a combination of thermal therapy with a self-management exercise have shown a positive effect in the management of osteoarthritis of the knee. this study aimed to compare the effectiveness of topical heat pack versus focal application of heat therapy at the acupressure points in the treatment of osteoarthritis of the knee.

osteoarthritis of the knee is a common degenerative joint disorder in our ageing population. a combination of thermal therapy with a self-management exercise have shown a positive effect in the management of osteoarthritis of the knee. this study aimed to compare the effectiveness of topical heat pack versus focal application of heat therapy at the acupressure points in the treatment of osteoarthritis of the knee. a randomized control trial was conducted in 76 patients with osteoarthritis of the knee, diagnosed by an experienced orthopedic surgeon. following inclusion and exclusion selection, patients were randomly allocated to group 1 (heat pack) or group 2 (thermal gun). all patients received 30 minutes of treatment in each session, twice a week for 4 weeks. they also received an education program and taught home knee exercises. outcome measurements were visual analog scale (vas) for pain intensity, muscle power, knee rom, womac and sf-12v2.

Eligibility criteria:
inclusion criteria: * male or female patients aged 40 years old or older * clinical and radiological diagnosis of osteoarthritis of the knee based on the oa knee clinical guidelines and radiological evidence * normal skin sensation to heat, cold, pins and pricks (i.e. passed the required skin sensation test) * not participating in any other clinical trial at time of this study * be able to complete the whole trial period * no cognitive dysfunction and was able to sign the consent form exclusion criteria: * received bilateral knee arthroplasty before this study * polyarthritis affecting more than both knee * active skin lesion * women in pregnancy or breasts feeding * received acupuncture and/or moxibustion within one month of the study * unable to comply with the study protocol

Keywords: knee osteoarthritis acupuncture randomized control trial
tetrandrine tablets used in hospitalized adults with covid-19

Conditions: COVID-19

Summary: the primary objective of this study is to evaluate the effectiveness of tetrandrine tablets in preventing the progression of covid-19 from severe to critical.

the primary objective of this study is to evaluate the effectiveness of tetrandrine tablets in preventing the progression of covid-19 from severe to critical. the secondary objective is to evaluate the clinical indicators of covid-19 with tetrandrine tablets treatment.

Eligibility criteria:
inclusion criteria: 1. sign informed consent form voluntarily for the trial. 2. male or female aged between 18 and 85 years (inclusive). 3. clinically or laboratory confirmed covid-19 within the past 7 days, as determined by a positive rt-pcr test or a positive antigen test. 4. under resting conditions, oxygen saturation ≤93% when breathing air, or p/f value ≤ 300 mmhg (1 mmhg = 0.133 kpa). 5. no birth plan and must agree to take effective contraceptive methods. exclusion criteria: 1. received a vaccine within 4 weeks prior to the study, or plan to receive a vaccine during the study period, or received treatment with tetrandrine tables prior to enrolling in the study. 2. patient must be on invasive mechanical ventilation/ecmo at baseline. 3. any clinically important serious diseases unstable or uncontrolled. 4. allergy history to any biological or other agent. 5. patient has severe mental or psychological abnormalities, cognitive impairment or intellectual disability before being diagnosed with covid-19. 6. subjects who are pregnant or breastfeeding, or plan to become pregnant during the study. 7. investigator think the subject should not participate in the study.
analgesic techniques for rib fractures

Conditions: Rib Fractures

Summary: this study will be a 3-arm, parallel-group, randomized controlled trial comparing three analgesic techniques for rib fractures with a sample size of 24 patients (8 per group). patients will be randomly assigned to one of the following three groups: 1) esp block with catheter using ropivacaine (bolus followed by continuous infusion); 2) lidocaine bolus (1 mg/kg) and infusion starting at 1 mg/kg/h; or 3) standard care with multimodal analgesia and opioids. our specific aims are: 1. to compare the opioid use and pain ratings over the first 72 hours after enrollment. 2. to quantify the changes in vital capacity, oxygen requirement, and freedom from mechanical ventilation that result from the intervention. 3. to explore the impact of esp blocks and lidocaine infusions on the development of chronic pain and post-discharge opioid use (exploratory). inclusion criteria: • adult patients ≥ 55 years old who have sustained 3 or more unilateral rib fractures and are admitted to the hospital. exclusion criteria: * allergy to amide local anesthetics, lidocaine, or ropivacaine * pregnancy * bilateral rib fractures * coagulopathy (inr \> 1.5; ptt \> 1.5 times uln, or platelets \< 75,000) * conduction block on ekg * total body weight \< 40 kg * painful distracting injuries: acute thoracic spine fracture, severe traumatic brain injury or spinal cord injury, unstable pelvic fracture, open abdomen * spine fracture at the level of intended esp block * infection near the esp insertion site or active bacteremia or sepsis * any patient deemed a poor candidate for esp block and/or lidocaine infusion will also be excluded


Eligibility criteria:
inclusion criteria: * ≥ 55 years old * sustained 3 or more unilateral rib fractures and are admitted to the hospital exclusion criteria: * allergy to amide local anesthetics or any study medications * pregnancy * bilateral rib fractures * coagulopathy (inr \> 1.5; platelets \< 100,000) * conduction block on ekg * spine fracture at the level of intended esp block * infection near the esp insertion site or active bacteremia or sepsis * any patient deemed a poor candidate for esp block and/or lidocaine infusion will also be excluded
characterization of anti-fgfr3 antibodies

Conditions: Sensory Peripheral Neuropathy

Summary: sensory neuronopathies affect sensory neuron in the posterior spinal ganglion. they are responsible for pain, balance disorder (ataxia) and the use of hands. they depend on multiple etiologies. in a retrospective study, the investigators showed that the anti-fgfr3 antibody is a diagnostic marker of a subset of sensory neuronopathies. the investigators believe that other antibodies can be discovered in patients who remain seronegative changing. however, the study is retrospective and only a small number of patients could be identified. several points therefore need to be clarified or confirmed in a second prospective study.

in and out patients evaluated for a sensory neuropathy meeting the inclusion and non-inclusion criteria will be proposed to enter the study at inclusion the ssn diagnostic score is calculated and a blood sample is tested for anti-fgfr3 antibody. follow up: patients positive for anti-fgfr3 antibodies will be followed and evaluated clinically and electrophysiologically at 1, 6 and 12 months. a blood sample is taken at 6 and 12 months. a subgroup of patients negative for anti-fgfr3 antibodies will be randomly selected for evaluation at 1, 6 and 12 months.

Eligibility criteria:
inclusion criteria: * a :patients male or female patient aged 18 years or more patients with a clinically pure sensory peripheral neuropathy including : * idiopathic or dysimmune sensory neuronopathies * idiopathic or dysimmune distal axonal sensory neuropathy * sensory chronic inflammatory demyelinating polyradiculoneuropathy * idiopathic or dysimmune small fiber neuropathies * idiopathic or dysimmune trigeminal nerve neuropathy * positive to antibodies anti-fgfr3 b :controls male or female patient aged 18 years or more patients with a clinically pure sensory peripheral neuropathy including : * idiopathic or dysimmune sensory neuronopathies * idiopathic or dysimmune distal axonal sensory neuropathy * sensory chronic inflammatory demyelinating polyradiculoneuropathy * idiopathic or dysimmune small fiber neuropathies * idiopathic or dysimmune trigeminal nerve neuropathy * negative to antibodies anti-fgfr3 exclusion criteria: * -motor or sensory-motor neuropathies * genetic, toxic, paraneoplasic neuropathies * diabetic neuropathy. * neuropathy with anti-mag or anti-ganglioside igm. * pregnant or breastfeeding woman

Keywords: neuropathy antibodies antifgfr3 biological diagnostic criteria
autonomic dysfunction in resistant hypertension

Conditions: Hypertension, Resistant to Conventional Therapy

Summary: the contribution of this study is the unedited evaluation of the circadian autonomic profiles of resistant hypertension with and without white-coat response.

all patients were submitted to office blood pressure measurement, ambulatory blood pressure monitoring and 24-hour holter monitoring. baseline blood samples for the measurement of glycemia (mg/dl), total cholesterol (mg/dl), ldl cholesterol (mg/dl), triglycerides (mg/dl), creatinine (mg/dl), serum uric acid, serum sodium, serum potassium, plasma aldosterone concentration (pac) and plasma renin activity (pra) were collected at 08:00 after overnight fasting.

Eligibility criteria:
inclusion criteria: * resistant hypertensive patients exclusion criteria: * white-coat hypertension * obstructive sleep apnea

Keywords: resistant hypertension white-coat phenomenon heart rate variability autonomic activity
efficacy and safety of tiradentes association in the treatment of acute pain

Conditions: Acute Pain

Summary: the purpose of this study is to evaluate the efficacy and safety of tiradentes association in adolescents and adults with acute pain.


Eligibility criteria:
inclusion criteria: * ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms; * participants of both sexes, aged 15 years or more; * participants who require extraction of impacted mandibular third molar; * third molar with bone impactions observed in panoramic radiography, with classification of winter (1926) mesioangular or vertical, and classification according to pell \& gregory (1933) class ii position b or class iii position a or b; * participants with acute pain of moderate or severe intensity after completion of surgery. exclusion criteria: * known hypersensitivity to the formula components used during the clinical trial; * history of alcohol and/or substance abuse within 2 years; * participants whose surgery for molar extraction lasted more than 50 minutes; * participants with known gastroduodenal ulcers or diagnosis of persistent gastritis; * participants who used sedatives or hypnotic agents before surgery; * anesthesia technical failure or need for more than three anesthetic tubes; * participants with temporomandibular joint dysfunction or limited mouth opening; * surgical accident that, in the investigator's opinion, may interfere with the procedures or evaluations of the trial; * postoperative complications such as, but not restricted to: neuropraxia and paresthesia; * participants who used any medication that acts on the pain mechanism in the 3 days prior to the start of the trial; * participants under chronic opioid treatment.

Keywords: acute pain
cerclage on low risk singletons: cervical cerclage for prevention of spontaneous preterm birth in low risk singleton pregnancies with short cervix

Conditions: Premature Birth

Summary: the aim of this study is to evaluate the efficacy of cervical cerclage in prevention of spontaneous preterm birth in singleton pregnancies with a short transvaginal cervical length (\<=25mm) and without prior spontaneous preterm birth

singleton pregnancies between 18 0/7 to 23 6/7 weeks without a prior spontaneous preterm birth found to have a short transvaginal ultrasound cervical length (\<=25mm) and meeting all other eligibility criteria will be randomized to either cervical cerclage or control (no cerclage). aside from cerclage placement, management of included women will be the same including recommendation for daily vaginal progesterone 200mg suppository or 90mg gel from randomization until 36 6/7 weeks. the primary outcome will be the incidence of spontaneous preterm birth \<35 weeks

Eligibility criteria:
inclusion criteria: * 18 year old or older * singleton pregnancy * no prior sptb or second trimester losses between 160 and 366 weeks * tvu cl ≤25mm between 180 and 236 weeks exclusion criteria: * multiple pregnancy * prior sptb or second trimester losses between 160 and 366 weeks * cerclage in situ * painful regular uterine contraction and/or preterm labor * rupture membranes * major fetal anomaly or aneuploidy * active vaginal bleeding * placenta previa and/or accreta * cervical dilation \>1.0 cm and/or visible membranes by pelvic exam * suspicion of chorioamnionitis

Keywords: cerclage, preterm birth, short cervix
nexgen gender fixed bearing knee versus nexgen legacy knee posterior stabilized (lps) - flex fixed bearing knee: a study comparing two different knee prostheses

Conditions: Total Knee Arthroplasty

Summary: the purpose of this trial is to study potential differences between two prostheses, including: "feel of prosthesis" (i.e., how natural does the prosthesis feel), range of motion (rom), pain perception for each prosthesis, satisfaction, patella tracking and quantification of the removed bone anterior on the femur (weight).

the present study compares the gender prosthesis against the lps-flex in a bilateral study, where patients are given two different prostheses: gender on one side and lps-flex on the other side. patients are blinded to which prosthesis is selected for which side. the potential advantages of the gender prosthesis include: less post-op pain due to better sizing (less overhang), less post-op patellofemoral pain and less compromised extensor mechanism and better patella tracking (due to less overstuffing of the patellofemoral joint). design: the study is prospective, randomized, comparative and blinded. 24 female patients scheduled for simultaneous bilateral total knee arthroplasty are included (48 knees). power calculations cannot be performed as to how many patients are needed since no previous studies have been conducted. all patients are included and operated by consultant henrik husted. methods: patients are randomized to which side is operated with which prosthesis (lps-flex or gender); the operations are performed using standard instrumentation and standard approaches. at the operation the weight of the cut bone from the anterior femur is noted for each side. before discharge radiographs including skyline views are performed to evaluate patella tracking (and are repeated at the final out-patient check 1 year post-op). gait analyses are performed before operation and 1 year post-op. all other procedures are standard procedures already implemented in the department. patients follow an accelerated track (anorak, 1,2) with an intended los of 4 days for bilaterally operated knee-arthroplasties, all patients are discharged directly to their homes.

Eligibility criteria:
inclusion criteria: * female patients scheduled for simultaneous bilateral total knee arthroplasty (tka) are included * bilateral knee disease necessitating bilateral tka exclusion criteria: * male sex

Keywords: tka functional outcome pain rom gait