Kornimate/medical-research-clean huggingface dataset:
a study of the efficacy and safety of shr-1314 for adult active psoriatic arthritis

Conditions: Psoriatic Arthritis

Summary: this study is a randomized, double-blind, multicenter, placebo-controlled phase iii clinical study, consisting of a 4-week screening period, a 24-week core treatment period, a 24-week maintenance treatment period, and an 8-week safety follow-up period. it is planned to include 150 adult subjects with psoriatic arthritis.


Eligibility criteria:
inclusion criteria: 1. the subject voluntarily signs an informed consent form before any procedures related to the research start; 2. at the time of screening, it met the 2006 psoriatic arthritis classification standard (caspar)； 3. there is active psa before randomization; 4. have active plaque psoriasis (at least one plaque skin lesion) at the time of screening, or have a history of plaque psoriasis; 5. participants who have previously been treated with csdmards and/or nsaids still have active psoriatic arthritis disease. exclusion criteria: 1. existence of any of the following medical history or comorbid diseases: drug-induced psoriasis; other active inflammatory diseases or autoimmune diseases; history of organ transplantation; history of lymphocytic proliferation; severe infections, etc. 2. have received psoriatic arthritis or psoriasis drugs, such as intra-articular injections, plant preparations, etc. within a certain period of time in the past. 3. those who are allergic to the drug ingredients or excipients in this study, or are allergic to other biological agents. 4. a history of alcohol abuse or illegal drug abuse in pregnant or breastfeeding women, etc.
optical trocar to create the pneumoperitoneum in bariatric patients

Conditions: Obesity, Morbid; Bariatric Surgery Candidate; Surgery-Complications

Summary: laparoscopic bariatric surgery are becoming the most used procedure to treat the obesity. to facilitate safe initial access to the abdominal cavity, we insert an optical viewing trocar at the left hypocondrium. the aim of this study is to systematically evaluate all published data existing in the literature to analyze the safety of optical trocars in patients undergoing bariatric surgery and to compare these data with our experiences.

in this study we analyze data existing in the literature about the use of the optical trocars in patients undergoing bariatric surgery and we compare these data with our experiences. establishing pneumoperitoneum is classically performed using a veress needle or the open hasson technique, but obesity presents its own challenges when using these techniques, including thickened abdominal wall, variable anatomical landmarks, difficult and time-consuming dissection, air leak, inadequate pneumoperitoneum, subcutaneous emphysema, and difficulty with fascial closure

Eligibility criteria:
inclusion criteria: bmi\>40 kg/m2 bmi\>35 kg/m2with at least one associated major comorbidity exclusion criteria: secondary obesity due to endocrine and psychological disorders
prostate cancer diagnosis through nmr spectroscopy of semen and prostatic secretions

Conditions: Prostate Cancer

Summary: to develop the hypothesis that quantitative nmr spectroscopy of human semen can be used to diagnose prostate cancer.

any willing subject who meets the male gender requirements, who is competent, agrees to participate, and is able to understand the consent form.

Eligibility criteria:
inclusion criteria: * any willing subject who meets the male gender requirements, who is competent, agrees to participate, and is able to understand the consent form. exclusion criteria: * not sepcified.

Keywords: prostate nmr spectroscopy
"core stabilization exercises in hearing impaired children"

Conditions: Hearing Disorders in Children; Core Stabilization; Respiratory Muscle Strength; Respiratory Functions; Postural Control

Summary: in this study the investigators will examine the effects of core stabilization exercises on respiratory muscle strength, respiratory functions and postural control in hearing-impaired children.

hearing organs develop together with the vestibular system and work with close cooperation. because of this close neuro-anatomic relationship; cochlear, semicircular canal, or both may cause damage to the vestibular dysfunction, resulting in imbalance. sensory impairment in children with hearing loss may lead to decreased muscle strength and respiratory function with balance and coordination disorders. core stabilization is provided anatomically with abdominal muscles at the front, spinal and gluteal muscles at the back, diaphragm at the top and pelvic floor and hip muscles at the bottom. core stabilization training is a training to increase the strength, endurance and neuromuscular control of the aforementioned muscles. when the literature is checked, the invetigators find that postural control is being evaluated in children with hearing impairment, but there are few studies evaluating respiratory functions. however, they did not encounter a study in which respiratory muscle strength was assessed in these children. in this study the investigators will examine the effects of core stabilization exercises on respiratory muscle strength, respiratory functions and postural control in hearing-impaired children.

Eligibility criteria:
inclusion criteria: * between the ages of 7-16 * clinically diagnosed sensorineural hearing loss * prelingual hearing loss * no neurological and orthopedic problems * absence of syndrome or disease that may lead to mental disorder, impaired development and impaired vision * not participating in any core stabilization, strengthening and balance program in the past six months * no medication to affect respiratory functions in the past 3 months * parental permission for participation of child in the study exclusion criteria: * intellectual disability for participating to the evaluation and training program * presence of chronic respiratory disease * not to join the training for more than 3 days
health of ivf versus ivm children (fm-babies)

Conditions: Infertility; IVF; IVM

Summary: the investigators conduct a follow up of our randomized controlled trial (rct) to investigate the development of children born from in-vitro fertilization (ivf) and in-vitro maturation (ivm), in order to give strong evidence about the safety of ivm in women with high antral follicle count or especially polycystic ovary syndrome (pcos).

since the birth of the first baby born from in-vitro maturation (ivm) in 1991, this technique has been considered an alternative solution for treating infertility beside conventional controlled ovarian stimulation for in-vitro fertilization (ivf). since then, there are already more than 5000 children born from ivm, and that number is on the trend of increasing. regarding technique, immature oocytes (germinal vesicle - gv) were aspirated from secondary follicles sized from 2-10mm, under follicle-stimulating hormone (fsh) priming or no ovarian stimulation at all. afterward, the maturation process was undertaken in an artificial medium, out of a living body. this technique, by reducing the usage of external hormones, is highly effective in minimizing the risk of ovarian hyperstimulation syndrome (ohss) in women with high antral follicle count, especially polycystic ovarian syndrome, with a rate of ohss recorded as low as 0 percent. alongside that, the pregnancy rate, as well as the live birth rate of ivm, when proceeded well, is not lower than conventional ivf. until now, there is only one randomized controlled trial comparing these two techniques directly. due to differences in the process of culturing between ivm and ivf, primarily the maturation is undertaken in an artificial medium, the health of children born from ivm received many interests. numerous studies have been conducted to compare the development of children born from ivm and ivf. neonatal outcomes of children born from ivm and ivf are considerably comparable. and the development of children born from these two techniques is not significantly different. all the information, as mentioned above, was not from randomized controlled trials but retrospective or prospective cohort studies. thus, we conduct a follow up of our rct to investigate the development of children born from ivm and ivm, to give strong evidence about the safety of ivm in women with high antral follicle count or especially pcos.

Eligibility criteria:
inclusion criteria: * all live babies born following the in-vitro maturation and in-vitro fertilization from our fm study. * parents agree to participate in the study. exclusion criteria: * babies died under or at 24 months

Keywords: ivf ivm asq-3 health of children
concomitant intranasal antihistamine and corticosteroid in stepwise treatment strategy for allergic rhinitis

Conditions: Allergic Rhinitis

Summary: patients with perennial allergic rhinitis whose symptoms are not controlled (visual analogue scale \[vas\] ≥5) by 2-week treatment with intranasal corticosteroid will receive concomitant intranasal antihistamine and corticosteroid for 2 weeks. after 2-week treatment, changes in clinical parameters including vas, total nasal symptom score (tnss), total ocular symptom score (toss), rhinoconjunctivitis quality-of-life questionnaires (rqlq) will be evaluated.

patients with perennial allergic rhinitis whose symptoms are not controlled (visual analogue scale \[vas\] ≥5) by 2-week treatment with intranasal corticosteroid will receive concomitant intranasal antihistamine and corticosteroid. in addition to vas, total nasal symptom score (tnss), total ocular symptom score (toss), rhinoconjunctivitis quality-of-life questionnaires (rqlq) will be measured before treatment (baseline) and 2 week after treatment. the differences between parameters before treatment and those after 2-week treatment will be statistically analyzed using paired student t test, and p\<0.05 was considered statistically significant.

Eligibility criteria:
inclusion criteria: * perinnial allergic rhinitis diagnosed by a doctor * positive for one or more of inhalant perinneal allergen in skin prick test or serum specific ige measurement * age: 19 years or older * allergic rhinitis symptoms not controlled (vas ≥5) by 2-week treatment with intranasal corticosteroid exclusion criteria: * compliance for one or more drugs in last 2 weeks: \<80% * use of oral corticosteroid, oral or intranasal decongestant in last 2 weeks * initiation of allergen-specific immunotherapy in last 12 months * seasonal allergic rhinitis * chronic rhinosinusitis other than allergic rhinitis * nasal polyposis * comorbid diseases including infectious, respiratory, cardiologic, renal, gastrointestinal, endocrinologic, oncologic, hemotologic and immunologic disorders which investigators judge to affect on the study significantly. * patients' rejection * pregenancy or lactation
tc-110 t cells in adults with relapsed or refractory non-hodgkin lymphoma or acute lymphoblastic leukemia

Conditions: Non Hodgkin Lymphoma; Acute Lymphoblastic Leukemia; Diffuse Large B Cell Lymphoma; Primary Mediastinal Large B Cell Lymphoma; Mantle Cell Lymphoma; Follicular Lymphoma

Summary: tc-110 t cells are a novel cell therapy that consists of autologous genetically engineered t cells expressing a single-domain antibody that recognizes human cd19, fused to the cd3-epsilon subunit which, upon expression, is incorporated into the endogenous t cell receptor (tcr) complex. this is a phase 1/2 open-label study to evaluate the safety of autologous genetically engineered tc-110 t cells in patients with aggressive nhl (dlbcl, pmbcl, tfl), high-risk indolent nhl (including mcl), or adult all.


Eligibility criteria:
inclusion criteria: * patient is \> 18 years of age at the time the informed consent is signed * patient has agreed to abide by all protocol-required procedures, including study-related assessments, and management by the treating institution for the duration of the study and ltfu * histologically confirmed nhl or all * eastern cooperative oncology group (ecog) performance status 0 or 1 * patient must have adequate organ function as indicated by the laboratory values in the clinical protocol * patient must be fit for leukapheresis and have adequate venous access for cell collection * patient must have evidence of cd19 expression * prior cd19-directed car t therapy is allowed
study of single platelet-rich plasma local injection vs. single corticosteroid local injection in carpal tunnel syndrome

Conditions: Carpal Tunnel Syndrome

Summary: this clinical trial aims to evaluate the effect of a single local platelet-rich plasma injection versus local steroid injection in treating mild idiopathic carpal tunnel syndrome regarding pain relief and function improvement and electrophysiological studies of the median nerve as a baseline and during a follow-up period of 3 months. the main question\[s\] it aims to answer are: * does platelet-rich plasma injection provide better pain relief for cts symptoms than steroid injection? * does platelet-rich plasma improve parameters of median nerve conduction study than local steroid? participants will have: * a complete history and clinical examination, including sensory and motor examination and provocative tests for cts. * visual analog scale (vas), symptom severity scale (sss), and functional severity scale (fss) of the boston carpal tunnel questionnaire (bctq) before local injection and three months after local injection by the same investigator. * nerve conduction studies (ncs) for median and ulnar nerves were carried out before local injection and three months after local injection by the same investigator. researchers will compare the efficacy of a single prp local injection compared to a single corticosteroid local injection for treating mild idiopathic cts using nerve conduction studies (ncs), visual analog scale (vas), and boston carpal tunnel questionnaire (bctq) as objective and subjective outcome measures.

carpal tunnel syndrome (cts) is the most known entrapment neuropathy. diagnosis of cts is clinical, which could be confirmed by nerve conduction study (ncs). non-operative management is the first line of treatment, including splitting, antiinflammatory, and neurotonics. there is evidence of improvement in cts after local corticosteroid injection, but complications are still recorded \[5\]. platelet-rich plasma (prp) is a novel, promising treatment providing growth factors for nerve regeneration and inflammation relief. this field needs further evaluation and analysis compared to traditional local steroid injection.

Eligibility criteria:
inclusion criteria: * patients with mild primary cts complaining of paresthesia in the palmar aspect of lateral three and half fingers of the hand. they are selected clinically and confirmed according to padua's neurophysiologic severity scale (pnss) for cts exclusion criteria: * patients were excluded if they had moderate-to-severe ncs findings, space-occupying lesions within the carpal tunnel, traumatic cts, pregnancy, diabetes mellitus, rheumatoid arthritis, or previous cts surgery.

Keywords: carpal tunnel syndrome corticosteroids platelet-rich plasma nerve conduction study boston questionnaire visual analogue scale
evaluation of a clinical decision support system for fungal infections

Conditions: Invasive Fungal Infections

Summary: invasive fungal infections are serious and frequent diseases in our hospitals, especially in intensive care units. in accordance with the institutional recommendations, it is necessary to have a clinical decision support system to support the clinicians in a rapid and optimal prescription of antifungals for invasive fungal diseases. this clinical decision support system will benefit patients but also clinicians who will gain in medical efficiency. it will also have an ethical dimension since it will guarantee optimal antifungal treatments for all patients. the purpose of the research is to define the percentage of concordance between the medical prescription and the recommendation of the clinical decision support system.


Eligibility criteria:
inclusion criteria: * patients receiving antifungal therapy for the treatment of invasive fungal disease exclusion criteria: * patients not receiving antifungal therapy for the treatment of invasive fungal disease

Keywords: invasive fungal infections antifungal treatment clinical decision support system
contribution of cognitivo-behavorial therapy in shoulder apprehension

Conditions: Shoulder Dislocation; Shoulder Instability

Summary: randomized controlled double-blind study aimed at studying the contribution of cognitive-behavioral therapy in the treatment of shoulder apprehension. comparison of 2 physiotherapy techniques in the context of shoulder instability. control group: rehabilitation physiotherapy by physiotherapist using conventional technique alone. intervention group: rehabilitation physiotherapy by physiotherapist according to conventional technique, with the addition of techniques from cognitive-behavioral therapies.

traumatic anterior instability of the shoulder is one of the most frequent lesions of the shoulder, the majority of cases of which occur in adolescents, with a risk of recurrence close to 90% if it occurs before the age of 20 years. it can be treated conservatively or surgically. stabilizing surgery of the glenohumeral joint offers satisfactory results for people suffering from shoulder instability. like subjects treated conservatively, patients undergoing stabilizing surgery remain apprehensive after the operation in 2 to 51% of cases. currently, no rehabilitation program has demonstrated superior effectiveness, during instability treated conservatively or during postoperative rehabilitation. recent studies have shown that cortical reorganization takes place, especially in areas of fear and anxiety. faced with the need to develop physiotherapeutic management in post-traumatic unstable shoulder, this study aims to evaluate the contribution of cognitive-behavioral therapy, by including a neuropsychological axis in the rehabilitation of patients. this study is randomized and controlled, multicenter, including 144 patients suffering from apprehension of the shoulder, divided into two treatment groups. both groups will receive a conventional physiotherapy protocol including individual sessions and home exercises. the physiotherapists in the intervention group will also have received training in the use of techniques from cognitive-behavioral therapies. data will be collected before the introduction of physiotherapy, after 6, 12, 24 and 52 weeks of treatment. in the event of surgery, the data will also be collected preoperatively. the primary outcome is apprehension measured by the rowe score. the secondary outcomes are apprehension measured by the apprehension and relocation tests, and the tampa scale for kinesiophobia, as well as shoulder function, measured by the simple shoulder test and the subjective shoulder value.

Eligibility criteria:
inclusion criteria: * positive apprehension test; * traumatic anterior dislocation of the glenohumeral joint requiring or not surgical stabilization according to bankart or latarjet; * good oral and written comprehension of french; * age between 15 and 45 years old. exclusion criteria: * associated tendon injury requiring surgical treatment; * fracture other than bankart fracture; * multidirectional instability (mdi); * peripheral neurological lesion in the upper limb; * central neurological lesion; * diagnosed psychosis, depression or epilepsy.
superiority trial evaluating digitalized information media for patients with advanced sarcomas receiving second line treatment.

Conditions: Sarcoma Metastatic; Locally Advanced Soft Tissue Sarcoma

Summary: epps-2202 is a study designed to evaluate the benefits of a dematerialised personalised care plan (pcp) compared to standard information/pcp for patients with advanced sarcomas receiving second-line treatment. participants will be randomised to an experimental group or a control group. patients in the experimental group will receive the dematerialised pcp in addition to the standard pcp while patients in the control group will receive the standard pcp alone. all patients will be followed until the end of second-line treatment, the start of a new line of treatment, or until the 24-month follow-up.

epps-2202 is a phase 3, randomised,open-label, controlled, multicentre interventional study, designed to evaluate the benefits of a dematerialised personalised care plan (pcp) compared to standard information/pcp in patients with metastatic of locally advanced sarcomas with indication of a second-line treatment with pazopanib, tracbectedine, eribuline, ifosfamide or dacarbazine after failure of a first-line anthracycline-based regimen. participants will be randomised to the experimental arm or the control arm. patients in the experimental arm will receive the dematerialised pcp in addition to the standard pcp while patients in the control arm will receive the standard pcp alone. all patients will be followed until the end of second-line treatment, the start of a new line of treatment, or until the 24-month follow-up. the main analysis will compare the proportion of patients in each arm who experience at least one severe adverse event during the first 3 months of second-line treatment. adverse events will be considered severe if they are graded 3 or higher according to nci-ctcae v5.0.

Eligibility criteria:
inclusion criteria: * sarcomas of soft tissues or viscera ; * inoperable metastatic or locally advanced disease ; * indication for 2nd-line treatment with pazopanib, trabectedine, eribulin, ifosfamide or dacarbazine after failure of 1st-line anthracycline therapy ; * patient covered by french social security ; * written, signed, informed consent ; exclusion criteria: * poor understanding of french ; * difficulty accessing a computer ; * pregnant or nursing woman ; * person deprived of liberty or under guardianship ; * impossibility of undergoing medical follow-up for geographical, social or psychological reasons.

Keywords: sarcoma advanced dematerialised care plan