Kornimate/medical-research-clean huggingface dataset:
the effectiveness of thoracal epidural steroid and local anesthetic injection

Conditions: Chronic Postoperative Pain; Chest Pain; Back Pain

Summary: the primary objective was to evaluate the effectiveness of thoracic interlaminar epidural injections in alleviating pain and enhancing function in patients suffering from chronic mid and/or upper back pain. materials and methods one hundred patients were randomly divided into two groups, each consisting of 50 patients. group i received only a local anesthetic, while group ii received a combination of local anesthetic and steroids. the random assignment to either group i or group ii was determined using a simple computer-generated sequence. outcomes were evaluated using the numeric rating scale (nrs) and the revised oswestry disability index (rodi). patients who showed significant improvement for more than four weeks after the first two procedures were deemed successful. those who did not were classified as failed participants. significant improvement was defined as a reduction of more than 50% in both nrs and rodi scores, with assessments conducted at baseline and at 3, 6, and 12 months post-treatment. the center where the study was conducted: ankara university, faculty of medicine, department of anesthesiology and reanimation, division of algology, ankara, turkey


Eligibility criteria:
inclusion criteria: * \> 18 years old * \> 6 months pain duration * failed conservative management (including medication, physical therapy, and exercise programs) * facet joint pain ruled out (confirmed through diagnostic blocks) exclusion criteria: * \< 18 years old * having a psychological illness * allergies to local anesthetics or steroids * thoracic facet joint pain * significant disc herniation * infection ( which were ruled out by pre-procedure blood tests and c-reactive protein levels)

Keywords: chronic thoracic pain chest wall pain thoracic interlaminar epidural injections
study to assess safety, tolerability and efficacy of incremental doses of mgb-bp-3 in patients with cdad

Conditions: Clostridium Difficile Infection

Summary: the objective of this phase iia study is to assess the safety, tolerability, and efficacy of incremental doses of mgb-bp-3 in patients with clostridium difficile-associated diarrhea (cdad).

this is an exploratory, phase iia, open-label study assessing the safety, tolerability, and efficacy of incremental doses of mgb-bp-3 with 3 sequential groups of 10 patients with cdad. patients will be administered an oral dose of mgb-bp-3 for 10 days (day 1 to day 10). at the end of the treatment period, patients will be followed for up to 8 weeks to assess the incidence of disease recurrence.

Eligibility criteria:
main inclusion criteria: 1. age 18 years or older of any gender. 2. inpatients and/or outpatients who are able to attend all scheduled visits. 3. patients with the first episode or the first recurrence of mild or moderate cdad. 4. confirmed diagnosis of mild or moderate cdad as defined by the infectious diseases society of america/society for healthcare epidemiology of america guidelines. main exclusion criteria: 1. patients with severe complicated cdad (including hypotension or shock, ileus, megacolon, pseudomembranous colitis). 2. a white blood cell count higher than 15,000 cells/ml. 3. a serum creatinine level greater than or equal to 1.5 times uln. 4. elevated liver enzymes alanine aminotransferase and aspartate aminotransferase greater than uln. 5. inflammatory bowel disease (ulcerative colitis or crohn's disease), microscopic colitis, or irritable bowel syndrome with chronic diarrhea. 6. any other non-c difficile diarrhea. 7. received treatment with a fecal transplant within 7 days and/or is anticipated to receive a fecal transplant during the study. 8. major gastrointestinal surgery (ie, significant bowel resection) within 3 months of enrollment (does not include appendectomy or cholecystectomy). 9. received laxatives within the previous 48 hours. 10. pregnant or lactating women. 11. prior (within 180 days of screening) or current use of anti-toxin antibodies. 12. have received a vaccine against c difficile. 13. any condition for which, in the opinion of the investigator, the treatment may pose a health risk to the patient.

Keywords: clostridium difficile cdad mgb-bp-3 novel anti-infective efficacy tolerability safety phase iia
a study to evaluate an nk-1 antiemetic for the prevention of post operative nausea and vomiting

Conditions: Postoperative Nausea and Vomiting; Nausea and Vomiting, Postoperative

Summary: this study is looking at a range of doses of this nk-1 receptor antagonist drug, for both safety and effectiveness in prevention ponv

a multicenter, randomized, double-blind, placebo-controlled, dose-ranging, parallel group phase ii study to evaluate the safety, efficacy, and pharmacokinetics of the oral neurokinin-1 receptor antagonist, gw67969, when administered with intravenous ondansetron hydrochloride for the prevention of post-operative nausea and vomiting (ponv) and post-discharge nausea and vomiting (pdnv) in female subjects with known risk factors for ponv who are undergoing surgical procedures associated with an increased emetogenic risk

Eligibility criteria:
inclusion criteria: * females age 18-55 * laparoscopic/laparotomic gynecological procedure of laparoscopic gallbladder removal exclusion criteria: * pregnant or breastfeeding * post-menopausal * not undergoing general anesthesia

Keywords: emesis nausea post operative nausea and vomiting vomiting ponv
limb salvage in peripheral arterial trauma patients

Conditions: Trauma Patients

Summary: the aim of this study is to determine risk factors associated with failure of limb salvage in patients with periphral arterial injuries with or without attempts of revascularization.

trauma to the vascular system can be devastating. peripheral arterial traumatic injuries rarely occur in isolation, often complicated by bone fractures and nerve injuries. as a result of these complex injury patterns, vascular extremity trauma presents unique challenges to injury management and is associated with significant morbidity. in all trauma- related injuries , trauma is now the third leading cause of death and number one cause of death in people between the ages of 1 and 44 years . vascular injuries comprise 3% of all civilian trauma and have significant potential morbidity. leg trauma is common. however, it is associated with a significant vascular injury.the high energy of crushing trauma can cause extensive tissue damage with detrimental outcome such as high morbidity and mortality.\[3\] management of associated life-threatening injuries takes priority which might lead to delay in definitive vascular repairs with subsequent limb loss.the most important risk factor for early limb loss is failed revascularization which is time dependent

Eligibility criteria:
inclusion criteria: * peripheral arterial trauma patients exclusion criteria: * trauma patients with vascular injuries other than peripheral arteries

Keywords: trauma patients with peripheral arterial trauma patients
study of 1cm versus 2cm margins for the surgical treatment of ct2n0m0 melanoma

Conditions: Malignant Melanoma

Summary: this is a randomized non-blinded pilot study for patients with melanoma staging ct2n0m0 who are candidates for surgical resection. the primary objective is to determine the feasibility of randomizing participants with ct2n0m0 malignant melanoma to surgical treatment with 1cm versus 2cm margins. study will try to determine overall survival for ct2n0m0 malignant melanoma after surgical treatment with 1cm versus 2cm margins.

after randomization, participants will undergo surgery with wide local excision with either 1cm or 2cm margins. the margin will be based upon the previous biopsy site or area of pigmentation. the skin and subcutaneous tissue (down to fascia) will be resected. closure considerations may require removal of additional tissue for non-oncologic purposes. as per standard of care, sentinel lymph node biopsy will be performed using a dual tracer technique (technetium radiolabeled sulfur colloid and isosulfan blue) with or without lymphoscintigraphy.

Eligibility criteria:
inclusion criteria: * biopsy proven t2 malignant melanoma. * eastern cooperative oncology group (ecog) score of 0-2. exclusion criteria: * visible additional disease that suggests a greater than t2 malignant melanoma * unable to tolerate general anesthesia * evidence of distant metastatic disease * melanoma located on face or digits

Keywords: melanoma ct2n0m0
comparison of rubber band ligation and haemorrhoidectomy in patients with symptomatic haemorrhoids grade iii

Conditions: Hemorrhoids; Hemorrhoids, Internal; PROM; Rectal Diseases

Summary: rationale: haemorrhoidal disease is one of the most common anorectal disorders which affects nearly half of the general population1. given the current numerous modalities the obvious question which needs to be answered is which treatment is the best. an interesting conclusion from a recent systematic review regarding operative procedures for haemorrhoidal disease is that all procedures have their own advantages and disadvantages. there is a need for evaluating treatment from the patient's point of view and transparency in surgical and non-surgical treatment outcome. so far there is no sufficiently large trial that meets that demand. objective: to establish the best treatment of patients with symptomatic haemorrhoids grade iii: haemorrhoidectomy versus rubber band ligation (rbl). patient bound effectiveness, clinical effectiveness and cost-utility of both treatments is compared; primary outcome is quality of life at 24 months measured with the eq-5d-5l with dutch rating and recurrence at one year post procedure. the assumption is that treatment with rubber band ligation is equally effective in comparison with haemorrhoidectomy in terms of quality of life. study design:multicentre randomized controlled non-inferiority trial with cost-utility analysis. two treatment protocols are compared: haemorrhoidectomy and rubber band ligation. study population: patients aged ≥ 18 years with symptomatic haemorrhoids gr iii. patients are recruited in multiple clinics during 18-24 months. intervention: participants are allocated to either rubber band ligation or haemorrhoidectomy. main study parameters/endpoints: primary outcome measure is quality of life at 24 months measured with the eq-5d-5l with dutch rating and recurrence at one year post procedure. secondary outcomes are: complaint reduction with proctology specific patient-related outcome measure (hss, prom, promhiss), vaizey score, resumption of work, pain (vas), complications and recurrence at two years.


Eligibility criteria:
inclusion criteria: * haemorrhoids grade iii (goligher classification) * age 18 years and older * sufficient understanding of the dutch written language (reading and writing) exclusion criteria: * previous rectal or anal surgery with the exception of rubber band ligation * previous surgery for haemorrhoids (at any time) * more than one injection treatment for haemorrhoids in the past 3 years * more than one rubber band ligation procedure in the past 3 years * previous rectal radiation * pre-existing sphincter injury * inflammatory bowel disease * medically unfit for surgery or for completion of the trial (asa\>iii) * pregnancy * hyper-coagulability disorders * patients previously randomised to this trial * not able or willing to provide written informed consent

Keywords: hemorrhoids hemorrhoidal disease rubber band ligation hemorrhoidectomy prom
safety and dose study of grn163l administered to patients with refractory or relapsed solid tumor malignancies

Conditions: Solid Tumor Malignancies

Summary: the purpose of this study is to determine the safety and the maximum tolerated dose of grn163l administration in treating patients with refractory or relapsed solid tumor malignancies.

grn163l is a telomerase template antagonist with in vitro and in vivo activity in a variety of tumor model systems. telomerase is an enzyme that is active primarily in tumor cells and is crucial for the indefinite growth of tumor cells. inhibition of telomerase may result in antineoplastic effects.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * male or female * measurable or evaluable solid tumor malignancy * relapsed, refractory, locally advanced, or metastatic disease * disease refractory to or not amenable to standard therapy * karnofsky performance status 70-100% * life expectancy 3 months or greater exclusion criteria: * pregnant or lactating women * primary central nervous system(cns) malignancy or active cns metastases * hematologic malignancy * chemotherapy within 4 weeks prior to study * mitomycin c, nitrosoureas within 6 weeks prior to study * high dose chemotherapy with stem cell support within 6 months prior to study * signal transduction inhibitors, monoclonal antibodies, etc. within 4 weeks prior to study * systemic hormonal therapy within 4 weeks prior to study * anticoagulant therapy, antiplatelet therapy within 2 weeks prior to study * radiotherapy within 4 weeks prior to study * significant cardiovascular disease * serious/active infection * major surgical procedures within 2 weeks

Keywords: refractory relapsed
a comprehensive peer mentor-based disease management program for medically complex substance users

Conditions: Substance Addiction

Summary: substance-using adults are admitted to hospital for medical complication from their drug and alcohol use at very high rates; yet, their care is often defined by low rates of referral to addiction treatment programs and recidivism. in 1997, we instituted an integrated medical-substance use treatment program at johns hopkins, the first step day hospital, designed for intensive post-acute care of previously hospitalized substance using adults. we have shown that patients with dual diagnoses admitted to first step more often complete their course of medical care and stay in recovery longer than patients not admitted to first step.(1;2) on discharge from first step, patients are medically stable and drug-free. their substance abuse care is transferred to an out-patient substance abuse treatment facility and their medical care is transferred to their primary care provider. unfortunately, many patients are lost to follow-up during this transition. we believe that a peer mentor-based disease management program (pm) can provide continuity of care that begins in first step and continues after discharge thereby increasing the proportion of patients who remain in treatment for their addiction and medical conditions. peer mentors are persons from the target community who have been in recovery for 5 or more years. in cooperation with patients and providers, peer mentors improve the integration of care, quality of care, and access to healthcare services. this pilot study will test the effectiveness of a peer mentor-based disease management program. the specific aims are to compare the impact of the pm intervention verses enhanced usual care on outcomes in three domains (1) medical/psychiatric health status, (2) addiction recovery, and (3) social resource acquisition. if successful, this study will provide evidence supporting a larger randomized controlled trial of the impact of field workers on post-acute care among patients with dual diagnoses.


Eligibility criteria:
inclusion criteria: * all patients admitted to an intensive day hospital focused on medically complex substanse users are eligible for enrolment exclusion criteria: * inability to provide informed consent

Keywords: addiction peer mentor adherence
a study for patients with diabetes mellitus (iopa)

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: the purpose of this study is to compare glycemic control (hba1c) in chinese patients with type 1 or type 2 diabetes when treated with insulin lispro low mixture and human insulin 30/70.


Eligibility criteria:
inclusion criteria: * clinically diagnosed type 1or type 2 diabetes for at least 2 months * aged between 18 and 70 (inclusive) * have been treated with human insulin mix 30/70 twice daily for at least 2 months prior to entering the study * have glycosylated hemoglobin (hb1ac) between 1.2 and 1.7 times the upper limit of normal reference range within 2 weeks prior to or at visit 1 * compliance with diet and insulin therapy and performs regular blood glucose monitoring exclusion criteria: * have used oral antidiabetic agents within 30 days prior to entry into the study * receive a total daily dose of insulin \>2 units/kilogram * have had more than two episodes of severe hypoglycemia within 6 months prior to entry into the study * have a body mass index \>35 kilograms per square meter (kg/m2) * receive chronic systemic glucocorticoid therapy

Keywords: diabetes type 1 type 2
a standard of care study of patients with major depressive disorder who have had an inadequate response to a selective serotonin reuptake/serotonin-norepinephrine reuptake inhibitor antidepressant

Conditions: Depressive Disorder, Major

Summary: the purpose of this study is to assess the safety (adverse events, serious adverse events, deaths, suicidality) of participants with major depressive disorder (mdd) treated according to the standard of care (soc).


Eligibility criteria:
inclusion criteria: * has a diagnosis of major depressive disorder (mdd) without psychotic features as confirmed by the mini international neuropsychiatric interview (mini) * treatment with an selective serotonin reuptake inhibitor (ssri)/serotonin-norepinephrine reuptake inhibitor (snri) for at least 6 weeks at an adequate dose (per massachusetts general hospital-antidepressant treatment response questionnaire \[mgh-atrq\]). specifically, one of the following in any formulation is allowed: ssris: citalopram, duloxetine, escitalopram, fluvoxamine, fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline; snris: venlafaxine, desvenlafaxine, vilazodone, or vortioxetine * in the opinion of the treating clinician, the participant requires augmentation of the current antidepressant treatment and plans to initiate augmentation treatment in the near future. the participant has agreed to receive augmentation treatment * is currently an outpatient receiving psychiatric care (not inpatient care settings) * has a body mass index (bmi) of 18-40 kilograms per meter square (kg/m\^2), inclusive exclusion criteria: * taking more than one antidepressant (regardless of class) at therapeutic doses (therapeutic doses per mgh-atrq). a second antidepressant is allowed to be taken at a lower dose if for sleep or pain management * is currently taking a benzodiazepine at higher doses than the equivalent of 3 milligrams (mg) of lorazepam * current diagnosis of a psychotic disorder including mdd with psychosis, bipolar disorder, intellectual disability, dementia, autism spectrum disorder, borderline personality disorder, or somatoform disorders * has treatment resistant depression (trd) as defined by lack of response (less than \[\<\] 25 percent \[%\] improvement) of 2 or more antidepressants of adequate dose (per mgh-atrq) and duration (6 weeks) in this episode * current diagnosis of ptsd, obsessive compulsive disorder, fibromyalgia, anorexia nervosa, or bulimia nervosa. participants may be enrolled if they have been in remission for the past year
masitinib in refractory active rheumatoid arthritis

Conditions: Rheumatoid Arthritis (RA)

Summary: the objective is to compare efficacy and safety of masitinib at 3 and 6 mg/kg/day to methotrexate, with a randomisation 1:1:1, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any dmard including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any dmard including biologic drugs.


Eligibility criteria:
inclusion criteria: 1. patient with rheumatoid arthritis diagnosed according to american college of rheumatology (acr) criteria for at least 6 months 2. patient with acr functional class i-iii 3. patient who have active ra 4. patient who failed (defined as active ra with stable dose during 3 months) methotrexate or any dmard including biologics drugs if patients previously failed methotrexate or methotrexate in combination with any dmard including biologics drugs 5. patient with a disease onset at \> 16 years of age exclusion criteria: 1. patient for whom the use of methotrexate is contraindicated as per its spc 2. patient with documented fibromyalgia 3. patient with lactose intolerance 4. patient presenting with cardiac disorders

Keywords: rheumatoid arthritis ra masitinib dmard methotrexate
duloxetine vs. active comparator in the treatment of patients with depression

Conditions: Depression

Summary: how duloxetine compares to a medication currently available for the treatment of patients diagnosed with depression


Eligibility criteria:
inclusion criteria: * must be at least 18 years of age * must be diagnosed with depression * must sign informed consent * women who can become pregnant must be using birth control exclusion criteria: * previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorder * history of substance abuse or dependence in the last year * patients who are suicidal * frequent or severe allergic reactions with multiple medications
prenatal endoscopic repair of fetal spina bifida

Conditions: Myelomeningocele

Summary: the purpose of this study is to determine the feasibility of prenatal minimally-invasive fetoscopic closure with i) uterine exteriorization for a minimally-invasive repair under amniotic carbon dioxide insufflation ii) two trocars for the dissection and the cover with one patch or the suture of the skin edges by stitch

compared with an open approach involving laparotomy and hysterotomy, an endoscopic approach for the prenatal surgery of myelomeningocele offers at least two potential advantages: i) it may reduce the maternal and obstetric morbidity related to the hysterotomy; ii) it may be performed earlier in gestation than open surgery, therefore potentially further reducing exposition of the spinal chord to the intraamniotic environment and thus improving the overall prognosis of the malformation. this study aims to evaluate the feasibility and potential benefits of a minimally invasive endoscopic procedure for the prenatal treatment of myelomeningocele in a single-center trial. technically the procedure will be performed through 2 intra-amniotic ports, under fetoscopic visualization and intra-amniotic carbon dioxide insufflation. the defect will be dissected and the cord replaced in the canal. closure will be performed by suturing paravertebral muscles using a barbed running suture. a duragen patch will be sutured when primary closure is deemed impossible.

Eligibility criteria:
inclusion criteria: * patient \> 18 years old, with an assumption by health insurance, understanding and speaking french * a term \< or = 26 +0 weeks gestational age * single-pregnancy * myelomeningocele with higher-level defect between s1 and t1 * arnold chiari anomaly * no associated anomaly or chromosic anomaly exclusion criteria: * severe foetal kyphoscoliosis associated * increased risk of preterm birth: cervical length \<15 mm, history of at least 2 late miscarriages, existing premature rupture of membrane * placenta previa, accreta or placental abruption * maternal obesity with bmi\> 35 * uterine anomalies : large interstitial uterine fibroid, uterine malformation * maternal infection with a foetal transmission risk: hiv, hbv, hcv * maternal contradiction in surgery or anesthesia * poor social status and/or social isolation * impossible post-surgery follow-up * want to have a medical pregnancy termination

Keywords: minimally-invasive endoscopic repair fetal surgery outcome foetus