Kornimate/medical-research-clean huggingface dataset:
effect of baclofen on marijuana withdrawal and relapse

Conditions: Marijuana Dependence

Summary: the purpose of this study is to determine if baclofen dose-dependently decreases marijuana's direct effects and symptoms of marijuana withdrawal and thus decreases marijuana relapse.

only a small percentage of dependent-marijuana smokers who are seeking treatment for their marijuana use are able to achieve sustained abstinence. the objective of this study is to investigate the interaction between marijuana and the potential treatment medication, baclofen, with the direct goal of using this information to improve marijuana treatment outcome. gabab agonists such as baclofen have been shown to attenuate the self-administration of cocaine, heroin, alcohol and nicotine (see cousins et al., 2002; haney et al., 2006). baclofen also appears to decrease withdrawal symptoms in heroin and alcohol abusers (akhondzadeh et al., 2000; addolorato et al., 2000). the purpose of this study is to determine if baclofen dose-dependently decreases marijuana's direct effects and symptoms of marijuana withdrawal and thus decreases marijuana relapse in our laboratory model. for the purposes of this model, relapse is defined as a return to marijuana use after a period of abstinence. the study will utilize an inpatient/outpatient, counter-balanced design, with each participant maintained on each of three medication conditions for 16 days: placebo and baclofen (60, 90 mg/day). participants will begin taking capsules during the outpatient phase so that the dose can be incremented up to the maintenance dose prior to the first inpatient day. further, clinical studies have shown that baclofen is most effective at decreasing cocaine's effects when administered for several weeks. during the inpatient study phases, participants will have the opportunity to self-administer placebo or active marijuana 6 times per day. this study will provide important information of the effect of baclofen as a potential treatment medication for marijuana dependence.

Eligibility criteria:
inclusion criteria: * current marijuana use: average of 3 marijuana cigarettes at least 4 times per week for the past 4 weeks * able to perform study procedures * 21-45 years of age * women practicing an effective form of birth control (condoms, diaphragm, birth control pill, iud) exclusion criteria: * current, repeated illicit drug use (other than marijuana) * presence of significant medical illness(e.g., diabetes, cardiovascular disease, hypertension, examination, laboratory clinically significant laboratory abnormalities) * history of heart disease * request for drug treatment * current parole or probation * pregnancy or current lactation * recent history of significant violent behavior * major current axis i psychopathology(e.g., major depressive disorder, bipolar disorder, suicide risk, schizophrenia) * current use of any prescription or over-the-counter medication

Keywords: baclofen marijuana dependence marijuana withdrawal
anterior cutaneus nerve and distal adductor canal block with usg for total knee replacement analgesia

Conditions: Pain Measurement; Knee Replacement Arthroplasty; Nerve Block

Summary: the goal of this clinical trial is to compare analhesia effects of adductor canal blockade versus distal adductur canal blockade added anterior cutaneus nerve block in total knee arthroplasty. the main questions it aims to answer are: * question 1: does distal adductor canal blockade + anterior cutaneus nerve blokade superior analgesia then adductor canal block for undergoing tkp? * question 2: does distal adductor canal blockade + anterior cutaneus nerve blokade decrease drain place pain on anterolateral face of knee?

patients with american society of anesthesiologists classification status i-iii scheduled for elective primary tka using standard spinal anesthesia enroll for this trial. after surgery patient divided two groups: 1- adductor canal blockade 2- distal adductor canal blockade + anterior femoral cutaneus nerve blockade. at postoperative 3th, 10th, 24th hour vas (visuel analouge scale), vas move, incision plase pain-for top and down of patella, drain place pain, motor strenght for femoral nerve and siyatic nerve, first analjesic requirement time, opioid consumption, total analcesic requirement will be recorded.

Eligibility criteria:
inclusion criteria: * total knee artroplasty * spinal anesthesia * asa 1-3 exclusion criteria: * bupivacaine allergy * coagulopathy * infection on injection site

Keywords: anterior femoral cutaneus nerve block distal adductor canal block total knee arthroplasthy
impact of community health workers on adherence to therapy for non-communicable chronic disease in chiapas, mexico

Conditions: Hypertension; Diabetes Mellitus, Type 2

Summary: this study evaluates the effectiveness of community health workers when added to routine care for patients with diabetes and high blood pressure in rural clinics in chiapas, mexico. it does so by recording information on adherence to therapy, blood pressure and hemoglobin a1c while a non-governmental organization working in mexico trains and introduces a community health worker program.

compañeros en salud (ces), an affiliate project of partners in health, has been working in the rural sierra of chiapas, mexico since february 2012. ces works in partnership with the local ministry of health to rehabilitate and staff existing government primary care clinics. each community's clinic is staffed by one ces project physician year-round. ces activities span the range of allopathic medicine, but the focus of the project is in the prevention, detection, diagnosis and management of non-communicable diseases (ncds) such as diabetes and hypertension. ces currently operates in several rural communities with catchment areas of approximately 1,500 - 2,500 people. routine care for ncds is based on national guidelines and consists of monthly in-clinic visits by primary care physicians. over 9 months in 2014 and again over 6 months in 2016, ces will introduce a community health worker program called "acompañantes" to its project communities to augment care of patients with ncds. acompañantes are lay health workers and members of the community who bridge the gap between project clinics and patients, improving understanding of ncds, their treatments, and adherence to therapy. the introduction of acompañantes to communities is planned in a once-every-three-months fashion, the most rapid roll-out logistically feasible for ces. the investigators' project will document their experience over this time, and for one year after introduction of the acompañantes program to all seven study communities, by documenting adherence to therapy, hemoglobin a1c, and blood pressure at every-three month intervals over this time frame.

Eligibility criteria:
inclusion criteria: * formal diagnosis of type ii diabetes mellitus, stage i or ii hypertension or both * daily medications required for patient's condition * residence and receipt of therapy within the study catchment area * age greater than or equal to 18 years. exclusion criteria: * known or suspected secondary hypertension * known or suspected type 1 diabetes * pregnancy * chronic use of glucocorticoids.
efficacy of moderate sedation for dental treatment of young children

Conditions: Dental Caries; Child Behavior; Conscious Sedation Failure During Procedure

Summary: there is lack of clinical trials on pediatric dental sedation. the purpose of this study is to test (using a randomized controlled trial design) the hypothesis that young children behavior during dental treatment improves with oral midazolam sedation. a further aim of this study was is explore whether behavior also changes over sessions needed to dental treatment completion.

there is a lack of clinical trials on pediatric dental sedation in children 3 years old and under. we investigated whether young children's behavior improves during dental treatment with combined oral ketamine and midazolam compared to midazolam alone or no sedation. healthy children under 36 months of age, presenting early childhood caries and referred to a pediatric dental sedation clinic were randomly assigned to receive combined midazolam (0.5 mg/kg) and ketamine (3 mg/kg) (mk), oral midazolam (1.0 mg/kg) (ms), or protective stabilization without sedative (ps). one observer scored children's behavior using the ohio state university behavior rating scale (osubrs) at determined points in a dental exam (no sedative) and treatment session. data were analyzed using non-parametric bivariate tests.

Eligibility criteria:
inclusion criteria: * healthy children (asa ps 1) * children under 36 months old * children presenting early childhood caries * children with no history of dental treatment exclusion criteria: * lost to follow-up

Keywords: preschool children
hood to coast injury study

Conditions: Pain

Summary: the purpose of this study is to examine how certain kinds of fruit juice that contain natural antioxidants and natural anti-inflammatory properties may reduce exercise-induced muscle pain and injury. participants will be recruited from registered participants in the hood to coast relay. the hood to coast relay race officials will post the study on their website to find interested teams. interested participants will then be contacted by the study staff by phone regarding the study's inclusion and exclusion criteria and to schedule the initial health screening visit. the participants will undergo an initial health screening and survey about muscle soreness, and then drink the investigational juice twice daily for 8 days. on the 7th day of drink administration, the participants will report to the starting location of the hood to coast relay to meet with the investigators for 30 minutes to survey muscle pain and juice tolerability. the participants will then participate in the hood to coast relay, drinking 2 more bottles of juice over the duration of the relay. at the conclusion of the relay, the participants will meet with study investigators to take the same short survey about muscle pain and juice tolerability.


Eligibility criteria:
inclusion criteria: * ability and willingness not to take any anti-inflammatory or pain relieving drugs during the course of the study, and not to seek any other treatment for any symptoms of muscle damage until completion of the study after the race. exclusion criteria: * the investigators will exclude individuals who have or are using antiepileptic drugs for pain, acupuncture, or transcutaneous electrical nerve stimulation within 3 weeks before enrollment * recent use (within 5 half-lives) of topical medications/anesthetics, muscle relaxants, tender point anesthetic injections within 2 months, systemic steroids within 3 months or any investigational drug/device in the prior 30 days.

Keywords: muscle pain
vectorflow tunneled dialysis catheter (tdc) versus palindrome tdc

Conditions: Renal Failure Chronic Requiring Hemodialysis; Chronic Renal Insufficiency

Summary: randomized two-arm study examining 90 day primary patency of two fda-approved tunneled dialysis catheters.

the vectorflow tunneled dialysis catheter is a novel symmetrical tip design tunneled dialysis catheter which in pre-clinical testing and retrospective review has improved flow and patency compared to other dialysis catheter designs. this study will compare 90 day patency rates of newly inserted vf catheters to the palindrome catheter both of which are fda approved devices and will inserted as standard of care. the palindrome catheter has been selected as the comparison device because it is also a symmetrical tip catheter design and prior studies by the manufacturer of this device suggests it has a lower occlusion rate and better flow compared to other catheter designs.

Eligibility criteria:
inclusion criteria: * end stage renal disease or acute renal failure requiring hemodialysis through a tunneled dialysis catheter * age \>18, age \<80 * capable of giving informed consent exclusion criteria: * coagulopathy defined as international normalized ration (inr) \>2 which cannot be corrected with fresh frozen plasma * platelet count \<50,000/microliter, which cannot be corrected with platelet transfusion * active skin infections at site of tdc insertion * presence of bacteremia or infected avg/avf within 7 days prior to enrollment * neutropenia defined as absolute neutrophil count less then 1,700/microliter * known central venous stenosis * occlusion of bilateral external and internal jugular veins or bilateral brachiocephalic veins or stenosis of the superior vena cava * functioning surgical hd access (ie avg/avf) or avg/avf which is expected to be functional within 90 days of enrollment * inability to provide informed consent * pregnant or nursing women * in the event a physician does not feel that either catheter would be appropriate for a subject, the subject will not be eligible to participate
lectine pathway in unstable carotid plaque

Conditions: Carotid Artery Plaque; Mannose-Binding Lectin Complement Pathway

Summary: the study is aimed to investigate the possible role of lectin pathway - an alternative pathway of complement activation - in affecting stability of carotid atherosclerotic plaques and the possible correlations with clinical neurologic features.

in addition to the known hemodynamic criteria, instable carotid plaques can be responsible for brain ischemia, therefore is paramount to identify preoperatively possible markers of plaque instability. the study is aimed to investigate the possible role of lectin pathway - an alternative pathway of complement activation - in affecting stability of carotid atherosclerotic plaques and the possible correlations with clinical neurologic features. study population will include 40 patients with internal carotid artery stenosis \>=70% (assessed by echocolordoppler), symptomatic or asymptomatic, surgically treated by endoarterectomy. removed plaques will be evaluated by histologic exam and immunofluorescence for ficolins 1-2-3 and mannose binding lectin (mbl). plasma samples will be used for elisa test of lectin pathway complement activation.

Eligibility criteria:
inclusion criteria: * patients undergone elective or urgent carotid endoarterectomy (cea) for internal carotid stenosis \>70% (assessed by velocimetric criteria) with or without neurologic symptoms exclusion criteria: * recent (\<20 days) major/minor stroke with positive ct scan * absolute contraindications to surgery (cardiac, respiratory, anesthesiologic risk)

Keywords: carotid artery atherosclerosis alternative complement pathway
a phase ⅰ clinical trial to evaluate the safety, tolerance, pharmacokinetics and pharmacodynamics of shr-3045 in healthy subjects

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of shr-3045 in healthy subjects.


Eligibility criteria:
inclusion criteria: 1. subjects with ability to understand the trial procedures and possible adverse events, voluntary participation in the trial. 2. subjects who can provide written informed consent. 3. males or females aged 18-55 years (both inclusive). 4. males with body weight ≥ 50 kg, or females with body weight ≥ 45 kg. 5. no clinically significant abnormalities in the medical history, general physical examinations, vital signs and laboratory tests. exclusion criteria: 1. participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening. 2. known or suspected history of drug abuse. 3. addiction to tobacco and alcohol. 4. individuals who are unable to adhere to the dietary requirements of this trial during the study period. 5. judged by the investigator, there are any other conditions that interfere with the results evaluation of the trial.
phase 2a study on intravenous infusion of autologous osteoblastic cells in severe osteoporosis

Conditions: Severe Osteoporosis

Summary: osteoporosis is a systemic skeletal disease characterized by low bone mass and microarchitectural deterioration of bone tissue, with a subsequent increase in bone fragility and susceptibility to fracture. osteoporosis is one of the most common and debilitating chronic diseases, and a global health concern with a high prevalence not only in western countries, but also in asia and latin america. most efficacious anti-osteoporotic treatments either inhibit bone resorption like bisphosphonates or denosumab or increase bone formation like teripartide an anabolic agent. anti-osteoporotic drugs have demonstrated safety and efficacy with an increase in bone mass and a decrease of fracture risk (at the hip) by 30 to 50% after 3 years of treatment (black et al., 1996; neer et al., 2001; meunier et al., 2004). despite the availability of pharmacological treatments, osteoporosis remains a significant health problem for patients who do not respond to the available treatments or fail to comply with their regimens. the present phase 2a study aims to demonstrate the safety and efficacy of preob®, a proprietary population of autologous osteoblastic cells, in the treatment of osteoporotic patients who do not respond to pharmacological treatments.


Eligibility criteria:
inclusion criteria: * diagnosis of severe osteoporosis * non-response to anti-osteoporotic treatment for over 2 years * normal hematology function * ability to provide a written, dated, and signed informed consent prior to any study related procedure, and to understand and comply with study requirements exclusion criteria: * positive serology for hepatitis b, hepatitis c, hiv, syphilis, htlv-1 * current or past medical disease that could interfere with the evaluation of the efficacy, as judged by the investigator * severe renal or hepatic impairment

Keywords: bone diseases metabolic bone diseases osteoporosis bone fractures osteoporotic fractures musculoskeletal diseases
impact of aromatherapy on the delirium of patients in intensive care unit

Conditions: Intensive Care Unit Delirium

Summary: the primary objective of this monocenter randomized controlled trial is to assess the efficacy of aromatherapy to prevent delirium in patients hospitalized in an intensive care unit.

secondary objectives: 1. to assess the efficacy of aromatherapy on : * the level of consciousness, * pain, * the duration of mechanical ventilation, * the occurence of an accidental extubation, * the length of stay in the intensive care unit, * the cumulative duration of delirium episodes, * the time until first episode of delirium, * the use of neuroleptics. 2. to determine the factors influencing the efficacy of aromatherapy. 3. to assess the safety of aromatherapy. conduct of research: after inclusion, patients will be randomized between the aromatherapy and control groups. treatment will be started on the same day as randomization. aromatherapy treatment will consist of a dermal application on the feet of a mixture of essential oils. control treatment will consist of a dermal application on the feet of apricot vegetable oil. the mixture of essential oils (aromatherapy group) or vegetable oil (control group) will be applied to the arch of the foot by massage, every eight hours, at a rate of six drops per application (3 drops per foot). treatment will continue until the patient is discharged from the intensive care unit or no later than 15 days after randomization.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * patient hospitalized in an intensive care unit for an expected duration of at least 24 hours * patient requiring mechanical ventilation with initial therapeutic sedation adapted secondarily for comfort sedation, defined by a rass score target between -2 and 0 * patient affiliated to/beneficiary of a social security scheme exclusion criteria: * allergy to essential and/or vegetable oils * palliative sedation * foot skin injury contraindicating the application of an oil * moribund patient or expected death * history of dementia * participation to a riph-1 study * pregnant or breastfeeding woman * patient under legal protection * patient deprived of liberty by judicial or administrative decision

Keywords: intensive care unit delirium aromatherapy
efficacy of intraoperative periarticular injections in hip fracture hemiarthroplasty

Conditions: Femoral Neck Fractures; Hemiarthroplasty; Blood Loss Requiring Transfusion

Summary: the objective of this study was to assess the effectiveness of the intraoperative periarticular solution in reducing blood loss and minimizing transfusion requirements in patients with femoral neck fractures who underwent hemiarthroplasty.

hip fractures in the elderly represent a significant public health challenge, marked by elevated rates of morbidity and mortality. the worldwide increase in life expectancy has led to a corresponding rise in the incidence of hip fractures. notably, increased perioperative blood loss has been identified as a critical factor that heightens the risk of complications and mortality. consequently, contemporary research efforts have focused on addressing this pivotal issue. various strategies have been developed, including controlled hypotensive anesthesia and the utilization of pharmacological agents aimed at reducing the perioperative blood products. the necessity for the efficacy of tranexamic acid (txa) in mitigating blood loss has been well-established across numerous surgical specialties. this study is motivated by the need for an effective and safe approach to perioperative blood salvage. to date, there appears to be a lack of research examining the effectiveness of the intraoperative periarticular injection technique (100 ml periarticular solution comprising 200 mg of bupivacaine (40 ml), 60 mg of ketorolac (2 ml), 8 mg of dexamethasone (2 ml), 2 mg of 1:1000 epinephrine (2 ml), and standard saline solution (54 ml). this solution was prepared in two 50 ml syringes. the first syringe containing 50 ml of the cocktail was injected into the capsule and gluteal muscles before femoral stem insertion. following joint capsule closure, the second syringe containing 50 ml of the periarticular injection cocktail was infiltrated into the fascia lata muscle, subcutaneous tissue, and wound layers) regarding blood loss reduction. therefore, this study aims to investigate the following questions: 1) is intraoperative periarticular injection an effective technique for minimizing blood loss in patients with hip fractures? and 2) what proportion of the salvaged blood loss can be attributed to hidden blood loss?

Eligibility criteria:
inclusion criteria: * clinical diagnosis of femoral neck fracture exclusion criteria: * anti-aggregant, anti-coagulant or anti-thrombotic therapy * pathological fractures, periprosthetic fractures, or revision procedures * intolerance or allergy to the medications utilized in the study * refused to participation

Keywords: hip fracture hemiarthroplasty periarticular injection blood loss blood transfusion requirement