Kornimate/medical-research-clean huggingface dataset:
a study in adult patients with major depressive disorder

Conditions: Depressive Disorder, Major

Summary: the purpose of this study is to assess whether ly2216684 is superior to placebo in the treatment of adult patients with major depressive disorder.


Eligibility criteria:
inclusion criteria: * adults age 18-65 years * meet criteria for major depressive disorder (mdd) as defined by diagnostic and statistical manual of mental disorders-fourth edition-text revision (dsm-iv-tr) criteria without psychotic features * women of child-bearing potential must test negative for pregnancy and agree to use a reliable method of birth control * grid 17-item hamilton rating scale for depression (grid-hamd17) total score ≥18 at visit 1 and visit 2 * clinical global impressions of severity (cgi-s) score ≥4 at visit 1 and visit 2 exclusion criteria: * are currently involved in or discontinued within the last 30 days from a clinical trial involving an off-label use of an investigational drug * have previously completed or withdrawn from this study or any other study investigating ly2216684 * have had or currently have any additional ongoing dsm-iv-tr axis 1 condition other than mdd * have had any anxiety disorder preceding the onset of depression that was considered the primary diagnosis within 1 year of visit 1 * have an axis ii disorder that would interfere with protocol compliance * have a current or previous diagnosis of bipolar i or ii, psychotic depression, schizophrenia, or other psychotic disorder * have a history of substance abuse within the past 1 year * women who are pregnant or breast-feeding * have had a lack of response of the current depressive episode to 2 or more adequate courses of antidepressant therapy, or in the judgment of the investigator, considered to have treatment-resistant depression * participants who are judged to be at serious suicidal risk * have a serious or unstable medical illness * have any diagnosed medical condition which could be exacerbated by noradrenergic agents including unstable hypertension, unstable heart disease, tachycardia or tachyarrhythmia, narrow angle glaucoma, or urinary hesitation or retention * have received treatment with a monoamine oxidase inhibitor (maoi) within 14 days prior to visit 1 * have a history of severe allergies to more than 1 class of medication or multiple adverse drug reactions * have a history of electroconvulsive therapy (ect), transcranial magnetic stimulation (tms) or psychosurgery within the last year * have a history of any seizure disorder (other than febrile seizures) * require psychotropic medication other than sedative/hypnotic medication for sleep * have a thyroid stimulating hormone (tsh) level outside the established reference range. * are taking or have received treatment with any excluded medication within 7 days prior to visit 2 * initiation or change in intensity of psychotherapy or other non-drug therapies within 6 weeks prior to enrollment * a positive urine drug screen for any substance of abuse at visit 1 * have initiated or discontinued hormone therapy within the previous 3 months prior to enrollment
prophylactic radiotherapy of minimally symptomatic spinal disease

Conditions: Spine Metastases

Summary: early palliative care has been shown to improve the quality of life and even survival for patients with metastatic cancer. more and more supportive oncology teams in cancer centers now advocate for early integration of radiation therapy (rt) in a patient's palliative management course. while multiple randomized studies have evaluated the efficacy of different rt regimens in the treatment of symptomatic bone lesions, few studies have examined the impact of early, upfront rt for asymptomatic or minimally symptomatic (non- opioid dependent) spine metastases and its efficacy in preventing skeletal-related events (sres). since the pathophysiology of spinal metastatic disease is distinct from other bony metastatic disease, the proposed trial seeks to understand whether it is beneficial to patients with minimally symptomatic disease to undergo upfront rt to reduce the risks of sres and their sequelae, including hospitalizations.


Eligibility criteria:
inclusion criteria: 1. histologically-confirmed solid tumor malignancy with greater than 5 sites of metastatic disease detected on cross-sectional imaging. 2. has high-risk bone metastases that are asymptomatic or minimally symptomatic (not requiring opioids). high risk metastases are defined as: 1. bulkiest sites of spinal osseous disease ≥ 2cm, 2. disease at junctional levels, including the thoracic apex (occiput to c2, c7-t1, t12-l2, and l5- s1) 3. disease with posterior element involvement, including interspinous, unilateral, or bilateral facet joints. 4. vertebral body compression deformity \> 50%. 3. eastern cooperative oncology group (ecog) performance status 0 - 2. 4. age ≥ 18 years. 5. able to provide informed consent. 6. patients at reproductive potential must agree to practice an effective contraceptive method. women of childbearing potential must not be pregnant or lactating. exclusion criteria: 1. previous rt to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances. 2. serious medical co-morbidities precluding rt. 3. pregnant or lactating women. 4. target lesion(s) is/are complicated bone metastases that include clinical or radiological evidence of spinal cord compression or impending pathological fracture. 5. leptomeningeal disease. 6. patients whose entry to the trial will cause unacceptable clinical delays in their planned management.

Keywords: radiotherapy (rt) palliative radiotherapy high-risk asymptomatic spine metastases minimal asymptomatic spine metastases
angiotensin-converting enzyme inhibitors and early sickle cell renal disease in children

Conditions: Sickle Cell Disease

Summary: patients with sickle cell anaemia may develop renal disease. in fact, renal disease occurred in 40% of adults patients (macroalbuminuria) with evolution to end-stage renal disease for half of them. microalbuminuria is an early and sensitive marker of glomerular damage. it appears during the first decade and occurred in 20 to 25% of infants (2 to 18 years). physiopathology of renal scarring is not well understood actually. renal scarring might be due to glomerular hyperfiltration and vascular and endothelial damage. angiotensin-converting enzyme inhibitors (ace) were studied and used in diabetic nephropathy. in a study on 26 sickle cell adults, albuminuria was reduced about 50% by ace compared to placebo after six months treatment. it might be interesting studying ace efficacy in sickle cell children with microalbuminuria because renal disease is directly related to sickle cell and is not influenced by other cardiovascular risk factors like in adult patients. we hypothesized to have a successful ace treatment in more than 40% of cases after a nine months treatment period. a success is defined as a 50% reduction of the albuminuria/creatinuria ratio.

this is a multicenter study. in order to include 72 patients we should pre-include 400 patients. they will be included in the study after signing the protocol consent. for final inclusion in the study, two albuminuria/creatinuria ratio should be over or equal to 3mg/mmol. if so, inclusion will be done and patient will be randomized (placebo/enalapril) by cleanweb software. a blood sample will be done. treatment tolerance will be check up at day 7 (blood sample for renal tolerance and clinical examination), month 1(clinical examination), month 3(clinical examination), month 6(clinical examination), and month 9 (clinical examination). treatment efficacy will be evaluated by albuminuria/creatinuria ratio at month 1, month 3, month 6, and month 9. physiopathology of ace efficacy will be studied at first day and month 9 by dosage of icam-1 and vcam-1. treatment plain posology (0.5mg/kg/day) will be progressively obtained on a three months period, beginning at 0.2mg/kg/day.

Eligibility criteria:
inclusion criteria: * sickle cell disease (ss, sc, sb thalassemia, sd punjab) * affiliation to french health benefits * signed informed consent * albuminemia / creatinemia \>= 3 mg / mmol (on 2 samples) exclusion criteria: * albuminemia / creatinemia \> 100 mg / mmol * hypersensibility to enalapril * angio-oedemas due to a previous treatment by ace * idiopathic or hereditary angio-oedemas * cerebral echo-doppler * treatment by lithium digoxine * treatment by other ace * congenital galactosemia * pregnancy

Keywords: angiotensin-converting enzyme inhibitors (ace) renal disease microalbuminemia
effectiveness of functional electric stimulation with bicycle ergometer and mirror therapy in stroke patients lower extremity

Conditions: Stroke

Summary: there are different methods in stroke rehabilitation. in addition to conventional techniques, functional electric stimulation with bicycle ergometer therapy and mirror therapy can be used. in this study, we will compare functional electric stimulation with bicycle ergometer therapy and mirror therapy in stroke patients.

aim of study is to compare functional electric stimulation with bicycle ergometer therapy and mirror therapy applied to lower extremity in stroke patients.

Eligibility criteria:
inclusion criteria: * 18-85 age * unilateral stroke * first time stroke * time after stroke less than 6 months * lower extremity brunnstrom stage: 2-4 * lower extremity spasticity modified ashworth scale: less than 3 * patient with sitting balance * mini mental test score higher than 23 * patients signed approval form exclusion criteria: * bilateral stroke * neurological disease other than stroke * psychiatric disease * lower extremity orthopedic problem * visual or audience problem * neglect * severe aphasia * contraindications of electrical stimulation (cardiac implantation etc.) * severe comorbidity (cardiac failure etc.) * seizure * acute deep vein thromboembolism * local infection * botulinum toxin injection of lower extremity less than 3 month

Keywords: stroke lower extremity mirror therapy functional electric stimulation bicycle ergometer
secondary cytoreductive surgery (crs) in patients with relapsed ovarian cancer who have progressed on parp inhibitor maintenance

Conditions: Ovarian Cancer; Drug Related Neoplasm/Cancer

Summary: this is a randomized phase ii study of secondary cytoreductive surgery (crs) in patients with relapsed ovarian cancer who have progressed on parp inhibitor maintenance.

the primary objective is to find out whether the crs is beneficial in patients who have progressed on parpi maintenance.

Eligibility criteria:
inclusion criteria: * patients with first recurrence of platinum sensitive, invasive epithelial ovarian-, fallopian tube- or primary peritoneal cancer of any initial stage. * progression-free interval of at least 6 months after end of last platinum- containing therapy, * progressed during parp inhibitor maintenance * women aged ≥ 18 years * complete resection of the tumor seems possible (estimated by an experienced surgeon). intra-abdominal disease has to be excluded by mri/ct, if other surgical approaches for isolated extra-abdominal recurrences are planned 1. a positive ago-score or imodel+pet/ct 2. patients who are likely to be completely resected according to the investigator's judgment will be allowed by consensus between pi(surgeon) and designated radiologist even if ago or imodel+pet/ct negative. * patients who have given their signed and written informed consent and their consent to data transmission and -processing. exclusion criteria: * patients with non-epithelial tumors as well as borderline tumors. * patients without recurrence who are scheduled for diagnostic/second-look surgery or debulking surgery after completion of chemotherapy * more than one prior chemotherapy * patients with second, third, or later recurrence * patients with second malignancies who have been treated by laparotomy, as well as other neoplasms, if the treatment might interfere with the treatment of relapsed ovarian cancer or if major impact on prognosis is expected. * patients with so-called platinum-refractory tumor, i.e. progression during chemotherapy or recurrence within 6 months after end of former first platinum- containing therapy * only palliative surgery planned * radiological signs suggesting metastases not accessible to surgical removal (i.e. complete resection is deemed impossible) * any concomitant disease not allowing surgery and/or chemotherapy * any medical history indicating excessive peri-operative risk * any current medication inducing considerable surgical risk (e.g. bleeding: due to oral anticoagulating agents, bevacizumab) * no assessable archival tumor tissue

Keywords: recurrent ovarian cancer parp inhibitor resistance secondary cytoreductive surgery progression during parp inhibitor maintenance
tanezumab in osteoarthritis of the hip or knee

Conditions: Osteoarthritis

Summary: the purpose of the study is to test the efficacy and safety of 2 doses of tanezumab compared to oxycodone cr and placebo in patients with osteoarthritis

this study was terminated on 13 dec 2010 following a us fda clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 june 2010 for potential safety issues.

Eligibility criteria:
inclusion criteria: * osteoarthritis of the knee or hip according to kellgren-lawrence x-ray grade of 2 exclusion criteria: * pregnancy or intent to become pregnant * bmi greater than 39 * other severe pain, significant cardiac, neurological or psychiatric disease

Keywords: monoclonal antibody rn624 pf-04383119 nerve growth factor oa pain arthritis
relieflink: a preventative mobile toolkit for follow-up care of psychiatric patients

Conditions: Suicide, Suicidal Ideation

Summary: the purpose of this study is to increase use and availability, as well as assess the feasibility of the relieflink (rl) application for use in conjunction with standard care to promote psychological health and prevent suicidal behavior.

the aims of this study of relieflink application are to determine the utility of relieflink self-reports of suicidal ideation, negative emotions, loneliness, subjective well-being, flourishing, mental toughness, positive emotions, learned optimism, resilience, and post-traumatic growth. additional aims are to evaluate the impact of relieflink on perceived access to/usage of care and resources and to explore participant acceptance of relieflink as a technological support for standard treatment through human systems engineering of treatment plan adherence and user interview.

Eligibility criteria:
inclusion criteria: * enrolled as patients seeking behavioral health treatment through the grady health system * speak english * sought inpatient and/or outpatient treatment with grady health system following a suicide attempt or ideation. * has personal access to a functioning iphone and service plan. exclusion criteria: * has significant cognitive impairments. * is actively psychotic or has an imminently life-threatening medical/psychiatric condition per provider evaluation.

Keywords: suicidal behavior, mobile application, mobile health tool
the volume effect of nerve hydrodissection for carpal tunnel syndrome

Conditions: Carpal Tunnel Syndrome

Summary: carpal tunnel syndrome (cts) is the most common peripheral entrapment neuropathy with involving compression of the median nerve in the carpal tunnel. although many conservative managements of cts, the effectiveness of these methods is insignificant or only persist for a short duration. the technique of nerve hydrodissection is now commonly used for peeling the nerve from surrounding soft tissue, which may help allow the impulse to pass, and rescue the nerve with ischemic damage. however, the exact effect and interval of hydrodissection are unknown because of the lack of well-designed studies hence, investigators design a randomized, double- blind, controlled trail to assess the therapeutic effect of ultrasound-guided nerve hydrodissection in patients with cts.

after obtaining written informed consent, patients clinically diagnosed with mild-to-moderate cts were inclused and randomized into three groups. group a, patients received one-session of ultrasoung-guided nerve hydrodissection with 10cc normal saline; group b, patients received one-session of ultrasoung-guided nerve hydrodissection with 5cc normal saline; the injection syringe was covered to obscure the nature of its contents and patients were asked to turn their head away so that they would not see the procedure. as a result, patients were blinded to the treatment condition. the primary outcome is boston carpal tunnel syndrome questionnaire (bctq) and secondary outcomes include visual analog scale (vas), cross-sectional area (csa) of the median nerve, sensory nerve conduction velocity of the median nerve, and global assessment of treatment. the evaluations were performed pretreatment as well as on the 2nd week, 1st, 3rd and 6th month after injecton.

Eligibility criteria:
inclusion criteria: * age between 20-80 year-old. * diagnosis was confirmed using an electrophysiological study exclusion criteria: * cancer * coagulopathy * pregnancy * inflammation status * cervical radiculopathy * polyneuropathy, brachial plexopathy * thoracic outlet syndrome * previously undergone wrist surgery or steroid injection for cts

Keywords: nerve hydrodissection
using a novel algorithm to improve the retrieval rate of inferior vena cava filters (iretrieve study)

Conditions: Venous Thromboembolism,; Pulmonary Embolism,; Deep Vein Thrombosis,

Summary: since 2003, that the first retrievable ivc filter was introduced in the u.s,improvements have been made in the filter design to resolve problems of structural integrity and increase the ability to remove the filter after longer periods of time.the fda issued a communication in august 2010 advising physicians to remove retrievable filters whenever possible and updated that letter again in may 2014 due to concerns that these retrievable ivc filters, intended for short-term placement, are not always removed once a patient's risk for pe subsides. known long term risks associated with ivc filters include but are not limited to lower limb deep vein thrombosis (dvt), filter fracture, filter migration, filter embolization and ivc perforation.

several studies have shown that approximately 80% to 85% of optional ivc filters are never retrieved. the successful removal of retrievable filters requires diligent patient follow-up and interdepartmental cooperation, and even so, successful removal is not always possible. american college of chest physicians (accp) guidelines for ivcf placement indications advocates a close, structured follow-up of retrievable ivcfs to improve filter retrieval rates. using a retrieval algorithm and pathway program, a score will trigger a secure email and text messages sent to both physician and patient at different timelines, for follow up so as to retrieve filter placed.

Eligibility criteria:
inclusion criteria: * data obtained in line with good clinical practice, applicable laws and regulation exclusion criteria: -

Keywords: inferior vena cava
efficiency of tisseel for sleeve gastrectomy complications

Conditions: Morbid Obesity

Summary: laparoscopic sleeve gastrectomy has emerged over the last 20 years as a treatment of choice in the surgical management of patients with morbid obesity. however, this restrictive procedure is accompanied by outcomes such as gastric fistula (5%), postoperative hemorrhage (1%) and intra-abdominal loco regional collections (1%). at present, there is no sufficiently reliable technique to prevent these complications.

the hypothesis is the following : the use of fibrin glue (tissucol ®) during laparoscopic sleeve gastrectomy would reduce the incidence of complications (gastric fistula, intra-abdominal hemorrhage and intra-abdominal locoregional collection). the aim is to investigate whether the use of fibrin glue (tissucol®) during laparoscopic sleeve gastrectomy reduces the incidence of postoperative complications (gastric fistula, intra-abdominal hemorrhage and intra-abdominal locoregional collection)

Eligibility criteria:
inclusion criteria: * obesity requiring bariatric surgery (laparoscopic sleeve gastrectomy) according to the haute autorité de santé * patients younger than 60 years old * bmi ≤ 60 kg/m2 * surgery accepted by an obesity-related specific committee * patient with social protection exclusion criteria: * previous bariatric or gastric surgery * bmi \> 60 kg/m2 * under 18 years old * allergy to tissucol® * peroperative fistula * consent not signed * incapable of giving his opinion * pregnancy or breast-feeding * contraindication to surgery * asa classification iv

Keywords: obesity surgical management sleeve gastrectomy
comparison of the effectiveness of different myofascial release techniques for the pectoralis minor muscle

Conditions: Pectoralis Minor Muscle Tension; Muscle Shortness; Mobility Limitation; Forward Scapular Posture; Rounded Shoulder Posture

Summary: the aim of this study was to compare the effects of self-myofascial release, myofascial release with a physiotherapist and instrument assisted soft tissue mobilization (iastm) techniques for the pectoralis minor muscle on pectoralis minor muscle length, rounded shoulder posture, glenohumeral joint total rotation range of motion (rom) and skin temperature in asymptomatic individuals.

in the literature, the effects of myofascial release and instrument assisted soft tissue mobilization (iastm) applications on individuals with pectoralis minor muscle are investigated, but the available evidence is insufficient. in a study conducted in asymptomatic individuals, self-myofascial release was found to be more effective than placebo application in increasing glenohumeral flexion joint range of motion (rom), improving pectoralis minor length and advanced scapular posture. however, there was one study comparing the short-term effectiveness of the self-myofascial release method and iastm methods on pectoralis minor length, glenohumeral total arch movement and skin temperature in individuals with short pectoralis minor, and the results of both applications were found to be similar. despite these studies in the current literature, the amount of evidence examining the effectiveness of myofascial release technique performed under the guidance of a physiotherapist in individuals with short pectoralis minor is insufficient. however, the number of studies comparing the immediate and short-term effects of different myofascial release methods on the pectoralis minor muscle lengthening is few. given the limited evidence available, different myofascial release methods may produce different short-term responses on the pectoralis minor muscle, with different results on muscle length, scapular position, glenohumeral total arch motion, and superficial skin temperature. therefore, the aim of this study was to compare the effects of 3 different myofascial release techniques on pectoralis minor muscle length, rounded shoulder posture, glenohumeral joint total rotation rom and skin temperature in asymptomatic individuals.

Eligibility criteria:
inclusion criteria: * between the ages of 18-35 * presence of pectoralis minor shortness * not having any upper extremity injury in the last 6 months exclusion criteria: * presence of upper extremity surgery in the last 12 months * presence of neurological disorder in the upper extremity * any sensory problems or open wounds around the shoulder