Kornimate/medical-research-clean huggingface dataset:
non-syndromic inherited anomalies of mineralized tooth tissues: a whole exome study to identify new pathogenic variants

Conditions: Amelogenesis Imperfecta; Dentinogenesis Imperfecta; Dentin Anomalies

Summary: exodent specifically aims to discover new genes and new mutations causing isolated amelogenesis imperfecta (ai) and dentinogenesis imperfecta (di) and other dentin anomalies. the key point for clinicians is to distinguish between non syndromic and syndromic disorders in order to improve patients guidance and counseling. to do so, two targeted ngs panel have been designed, one searching for isolated ai and the other for di. after 18 months, some families remain without any positive results. exodent project proposes those negative patients a whole exome sequencing (wes) approach to deeper explore their genetic background.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of amelogenesis imperfecta or dentinogenesis imerfecta or other dentin anomaly with no other signs or symptoms ( familial or isolated) * negative results after targeted ngs strategy for molecular diagnosis exclusion criteria: * absence of positive clinical diagnosis * diagnosis of syndromic disease

Keywords: amelogenesis imperfecta dentinogenesis imperfecta dentin anomalies whole exome study
assessment of paclitaxel-induced neuropathy

Conditions: Cancer; Breast Cancer; Ovarian Cancer

Summary: the purpose of this study is to collect clinical data, blood samples, and self reported symptoms from patients that experience unusually severe neuropathy after treatment with paclitaxel. this data will be used to develop predictive markers for neuropathy. blood samples will be used to create induced pluripotent stem (ips) cells and eventually artificial nerve cells to be used to study neuropathy in the lab.


Eligibility criteria:
inclusion criteria (severe toxicity group): * diagnosis of cancer (including, but not limited to, breast and ovarian cancer) * females aged 18 and older * history of grade 3 or higher peripheral neurotoxicity, any neuromotor, neurocortical, or neurocerebellar toxicity, myalgias or arthralgias refractory to non-steroidal anti-inflammatory drugs and steroids, ong-term persistence (\> 6 months) of grade 2 or higher peripheral neuropathy, or other unusually severe neurotoxicity approved for inclusion in study by principal investigator after completion of paclitaxel chemotherapy regimen or history of peripheral neuropathy that required treatment with narcotics or grade 2 or higher peripheral neuropathy after only 1 to 2 doses of paclitaxel. inclusion criteria (control group): * history of no neurotoxicity (grade 0) after completion of a standard paclitaxel-containing chemotherapy regimen * females age 18 and older * matched to a specified subject with neurotoxicity based on age (within 10 years), tumor type, chemotherapy regimen or total paclitaxel dosage, race, and ethnicity exclusion criteria : * treatment with other severely neurotoxic chemotherapy (i.e. cisplatin) prior to or concomitantly with paclitaxel. carboplatin therapy is allowed. * presence of peripheral neuropathy prior to paclitaxel therapy * poorly controlled or insulin-dependent diabetes or other condition likely to predispose to neurotoxicity (alcoholism, charcot-marie-tooth disease)
trial of lava-051 in patients with relapsed/refractory cll, mm, or aml

Conditions: Chronic Lymphocytic Leukemia; Multiple Myeloma; Acute Myeloid Leukemia

Summary: a phase 1, first-in-human trial to evaluate the safety and tolerability of lava-051 in patients with relapsed or refractory chronic lymphocytic leukemia (cll), multiple myeloma (mm), or acute myeloid leukemia (aml).

an open-label, phase 1 dose escalation trial with disease-specific expansion cohorts to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of lava-051 in patients with relapsed or refractory cll, mm, or aml. the trial was intended to be a phase 1/2 trial (but the trial never moved forward to phase 2).

Eligibility criteria:
key inclusion criteria 1. patient must be 18 years of age inclusive or above at the time of signing the informed consent. 2. patients with documented diagnosis of relapsed or refractory cll, mm, or aml who have failed to respond to or who have relapsed after prior therapy and are not amenable to standard treatments or for whom no standard treatments are available. 3. predicated life expectancy of ≥ 3 months. 4. ecog performance status of 0 or 1. 5. males or non-pregnant, non-breastfeeding females who are either: 1. surgically sterile. 2. female of childbearing potential with a negative pregnancy test and compliant with an effective contraceptive regimen. 3. female, postmenopausal. 4. male compliant with an effective contraceptive regimen. 5. male refraining from donating sperm. 6. capable of giving signed and dated informed consent prior to initiation of any trial-related procedures. key exclusion criteria 1. prior allogeneic bone marrow transplant if the patient still has active acute or chronic graft versus host disease requiring \>10 mg prednisone or equivalent corticosteroids. 2. concomitant malignancies except carcinoma in situ, basal or squamous cell skin carcinoma. patients who had no evidence of disease from another primary cancer for 2 or more years are allowed to participate in the trial. localized non-metastatic prostate cancer, not requiring systemic treatment, and for which no local treatment is planned, is allowed. 3. uncontrolled or severe intercurrent medical condition. 4. previous treatment with an aminobisphonsphonate iv (e.g. ibandronate, pamidronate, zoledronate) within 4 weeks prior to initial imp administration. 5. known ongoing drug or alcohol abuse in the opinion of the investigator. 6. previous autologous haematopoietic stem cell transplantation (hsct) or treatment with chimeric antigen receptor (car) t-cell therapy within 6 months prior to initial imp administration. 7. immunodeficiency disorders. 8. patients with richter's transformation are excluded. other eligibility criteria will apply during full screening.

Keywords: cll phase 1 dose escalation phase 1 safety open label mm aml relapsed refractory
effectiveness of meta-cognitive training (emc) in people with psychosis of brief evolution.

Conditions: Psychosis

Summary: the purpose of this study is to assess the effectiveness of meta-cognitive training (emc) in people with a brief psychotic disorder, especially positive symptoms. the secondary objectives would be to assess the effect of emc on metacognition (cognitive distortions and deficits in theory of mind), psychosocial functioning and quality of life, neuropsychological functioning and gender, as well as determine the changes produced by emc in the insight of each session and the maintenance of the effects of emc program at six months of treatment.

the study is a randomized clinical trial in which a group will receive the meta-cognitive training (emc) and a control group will receive a journal workshop. the evaluator will be blind to the group that owns the patients included. the total simple will be of 122 people with a psychotic disorder, less than 5 years of evolution and a score at or above 3 on the panss during the last year. patients should be attended in one of the next services: parc sanitari sant joan de déu, corporació sanitària parc taulí, hospital de la santa creu i sant pau, hospital clínic de valencia, centre d´higiene mental de les corts, institut d´assitència sanitària girona, servicio andaluz de granada, málaga y jaén. the assessment was performed at baseline, at the end of treatment and six month follow-up. the assessment includes: psychopathology and insight ( panss, psyrats, pdi, gaf, bdi, bcis, sumd), meta-cognition (jumping to conclusions, ipsaq, tci), neuropsychology (wcst, tmt, cpt-ii, tavec, wais) and social functioning and quality of life (efs, das-sv, slds). the insight will be assessed at the final of each session (bcis). the treatment and control group consist of 8 weekly sessions of 45-60 minutes with a total of 4 to 8 patients per group. the emc group material is translated and validated in spanish by investigators of the team. the primary analysis variable is the difference between the scores of experimental and control group in the symptoms scales (especially positive). secondary outcomes will change in other assessments of social functioning, metacognition (cognitive distortions and theory of mind) and neuropsychological variables. were analyzed using regression and ancova methods with spss 19.

Eligibility criteria:
inclusion criteria: * diagnosis of : schizophrenia, schizoaffective disorder, brief psychotic disorder, delusional disorder, schizophreniform disorder, psychotic disorder not otherwise specified. * less than 5 years of evolution. * score at or above 4 on the panss during the last year (delusions, grandiosity, suspiciousness). exclusion criteria: * neurological disorder which impairs cognition. * intellectual disability. * score at or above 5 on the panss ( hostility and uncooperativeness); score at or above 6 on the panss (suspiciousness).

Keywords: meta-cognition positive symptoms early phases schizophrenia
sleep hygiene education in mothers with preschool children

Conditions: Sleep; Habits; Neurodevelopmental Disorders

Summary: the goal of this clinical trial is to gain importance of sleep routine and environment in mothers have children with neurodevelopmental disorders. the main questions it aims to answer are: * what is the importance of sleep routine and environment in children with neurodevelopmental disorders? * what kind of an effect does the awareness that mothers gain through sleep trainings have? participants will: * evaluations will be applied to all participants * divided into intervention and control groups * the intervention group will be given "sleep training" and followed up for about 1 month. * the results between the two groups will be compared researchers will compare intervention and control groups to see if turning a healthy sleep routine into a life habit


Eligibility criteria:
inclusion criteria: * having a child with a neurodevelopmental disorder * be over 18 years old and literate * having a child(s) of pre-school age (3-6 years old) * communicating and collaborating exclusion criteria: * having a neurological or psychiatric disease that prevents communication and cooperation

Keywords: sleep hygiene neurodevelopmental disorders
study to assess the efficacy and safety of levetiracetam for the treatment of social anxiety disorder (generalized type)

Conditions: Anxiety Disorders

Summary: preclinical and clinical findings indicate that lev has some anxiolytic potential. there is reason to believe that compounds with anxiolytic activity may have broad clinical utility across the anxiety spectrum. this trial was intended to explore lev's utility in adults with social anxiety disorder.


Eligibility criteria:
inclusion criteria: * male or female outpatients between 18 and 70 years old inclusive; * symptoms of social anxiety disorders (generalized type) present for at least 1 year prior to selection visit; * had a score of \>=60 on the lsas at the selection visit and at the randomization visit. additionally, the clinician's gloal impression of change score must have been \>= 2 at the randomization visit; * had a telephone where they could be directly contacted. exclusion criteria: * history of autism or asperger's disease; * had another primary axis i disorder or fulfilled diagnostic and statistical manual of mental disorders-4th edition (dsm-iv) criteria in the 6 months prior to screening; * major depression as measured by a hamilton depression rating scale (ham-d-17 items) total score of \> 17 and/or a suicide subscale score on the ham-d-17 items of \> 2 at the selection or randomization visit; * history of electroconvulsive therapy within the prior 3 months; * history of psychotherapy which was not stable and ongoing for at least 6 months prior to visit 1; * clinical history of significantly impaired renal function with an estimated creatinine clearance below 80 ml/min; * clinically significant medical condition; * history of any clinically significant allergic condition or allergy to lev or pyrrolidone derivatives; * neutrophil count of less than 1800/µl.

Keywords: levetiracetam keppra
maxim® knee pop-top® tibia vs. regular maxim® knee tibia

Conditions: Osteoarthritis; Rheumatoid Arthritis; Traumatic Arthritis

Summary: the purpose of this prospective clinical data collection is to compare the outcomes of two different tibial bearings: the maxim® pop-top® tibia and maxim® modular tibia.

the purpose of this prospective clinical data collection is to document and compare the performance and clinical outcomes between the maxim® knee system with removable molded poly tibia and the maxim® knee system with modular tibial bearing as two treatment groups. fda has cleared these devices via premarket notification 510(k)'s k991753, k984623, k993159, k010027. the data gathered will be collated and used to provide feedback to designing engineers, support marketing efforts and answer potential questions from reimbursement agencies.

Eligibility criteria:
inclusion criteria: identical to the indications stated in the fda approved labeling for the device (cleared in 510(k) k991753, k984623, k993159, k010027). these indications are stated below: * painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. * correction of varus, valgus, or posttraumatic deformity. * correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. patient selection factors to be considered include: * need to obtain pain relief and improve function, * ability and willingness of the patient to follow instructions, including control of weight and activity level, * a good nutritional state of the patient, * the patient must have reached full skeletal maturity. * porous coated knee joint replacement prostheses have not been approved for non-cemented applications in the united states. exclusion criteria: identical to the contraindications stated in the fda approved labeling for the device (cleared in 510(k) k991753, k984623, k993159, k010027's). these contraindications are stated below: absolute contraindications include: * infection, * sepsis * osteomyelitis. relative contraindications include: * uncooperative patient or patient with neurologic disorders who are incapable of following directions, * osteoporosis, * metabolic disorders which may impair bone formation, * osteomalacia, * distant foci of infections which may spread to the implant site, * rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, * vascular insufficiency, muscular atrophy, neuromuscular disease, * incomplete or deficient soft tissue surrounding the knee.
phase ii pilot study of extracorporeal phototherapy for epidermolysis bullosa acquisita

Conditions: Epidermolysis Bullosa Acquisita

Summary: objectives: i. evaluate immunomodulation with extracorporeal photochemotherapy (ecp) in patients with epidermolysis bullosa acquisita. ii. investigate the effect of ecp on lymphocyte activity.

protocol outline: oral methoxsalen (8-mop) is administered 90 minutes prior to leukapheresis. blood mononuclear cells are exposed to ultraviolet a light for 3 hours, then returned to the patient. the process is repeated on 2 successive days. patients are re-treated every 3 to 4 weeks for a total of 6 treatments or until the skin has cleared.

Eligibility criteria:
* active epidermolysis bullosa acquisita

Keywords: dermatologic disorders epidermolysis bullosa genetic diseases and dysmorphic syndromes rare disease
internal limiting membrane peeling-reposition to treat idiopathic macular holes

Conditions: Macular Hole; Surgery

Summary: to compare the morphologic and functional outcomes of internal limiting membrane peeling-reposition versus peeling in idiopathic macular holes

this randomized clinical trial will be performed at a single center. eligible patients with idiopathic macular holes will be equally randomized to internal limiting membrane (ilm) peeling-reposition group or ilm peeling group through computer-aided random allocation. a standard 3-port pars plana vitrectomy was performed by a single surgeon using the constellation 23 gauge vitrectomy system (alcon laboratories inc, fort worth, texas, usa).after posterior vitreous detachment was achieved, peeling of the ilm was performed by an end gripping forceps with the assistance of brilliant blue g. in ilm peeling-reposition group, the peeled ilm flap is flatten back to peeled area with assistance of perfluoro-n-octane. in ilm peeling group, a round shape with 2.5 to 3.5 disc diameter of ilm is peeled. this is followed by a complete fluid-gas exchange. patients are encouraged to maintain a face-down position for two weeks postoperatively in two groups. postoperative measurements of bcva and spectral domain optical coherence tomography(sd-oct) are conducted at 1,3 and 6-month follow-up visits by independent masked observers. macular light sensitivity and fixation stability are determined with microperimetry at 1,3, and 6 months of follow-up. mf-erg, m-score chart and vfq-25 chart are performed 1,3, and 6 months of follow-up. comparison of bcva, anatomical closure were primarily performed between the two groups. then, the morphologic changes of inner retina and the functional parameters measured from microperimetry, mf-erg, m-score chart, vfq-25 chart were analyzed.

Eligibility criteria:
inclusion criteria: * the patients are diagnosed as macular hole by optical coherence tomography. * age ranges from 50 to 80 years. * the patients have indication for surgery. exclusion criteria: * traumatic macular hole. * combined with serious epiretinal membrane. * combined with diabetic retinopathy, hypertensive retinopathy. * combined with other ocular diseases, such as keratitis，uveitis，retinal vasculitis. * - 6.0 diopters or more of spherical equivalent, 26mm or more of axial length. * history of intraocular surgery. * presence of staphyloma. * other ocular diseases that could influence macular microstructure or visual function exit criteria: * for reposition group, the patients will exit the research if the peeled ilm cannot reposition successfully. * due to adverse events, especially severe adverse events, the researchers consider withdrawal of patients based on concerns of safety and ethics; * drop out; * the patients voluntarily withdraw the informed consent; * serious violation of the study protocol due to the subjects or investigators' reasons; * other reasons that the researchers believe for quitting the study.

Keywords: macular holes
tranexamic acid in major vascular surgery

Conditions: Blood Loss, Surgical

Summary: the purpose of this study is to determine whether tranexamic acid is effective in reducing intraoperative blood loss and necessity for haemotransfusion in patients undergoing open abdominal aortic aneurysm repair


Eligibility criteria:
inclusion criteria: * age \> 50 * able to give written informed consent * undergoing open abdominal aortic aneurysm repair exclusion criteria: * patients participating in a pharmaceutical clinical trial in the last 3 months * urgent/emergent surgery * allergy/intolerance to tranexamic acid * history of seizures * acute venous or arterial thrombosis * fibrinolytic conditions due to consumption coagulopathy * disseminated intravascular coagulation * haematuria * visual disturbances
the effect of nutrition for the colorectal cancer patients receiving chemotherapy-randomized controlled study

Conditions: Colorectal Cancer

Summary: we use clinical trial to explore the effect of nutrition support in colorectal cancer patients receiving postoperative adjuvant chemotherapy.

colorectal cancer is the most common cancer in taiwan. side effects induced by postoperative adjuvant chemotherapy will affect nutrition status and may delay treatment and affect prognosis. sarcopenia may be noted in some patients and increase the toxicities of chemotherapy. the studies of intervention include nutrition consultant and treatment like protein, fish oil or vitamin d supplement. premium amino acids include multiple amino acids and organic selenium and have effect in inhibition of tumor proliferation according to colorectal cancer cell and animal experiments.

Eligibility criteria:
inclusion criteria: * age \> 20 * radical operation for stage iii and stage ii with high risk colorectal cancer * agree to join the trial and sign the informed consent form exclusion criteria: * unable to receive chemotherapy * unstable vital sign * not suitable after evaluation by principal investigator

Keywords: colorectal cancer chemotherapy nutrition sarcopenia
kinetics of inflammation markers in maternal plasma: study of the correlation with the diagnosis of chorioamnionitis in women hospitalized for spontaneous rupture of the fetal membranes

Conditions: Patients With Spontaneous Rupture of the Fetal Membranes

Summary: the principal aim of this study is to help obstetricians to diagnose chorioamniotic infection early, in cases of premature rupture of the fetal membranes before 34 wa, by proposing earlier and more specific markers of infection than fbc and crp. the aim is to reduce vital and functional risk of acute chorioamnionitis for the mother, the fetus or the newborn,. if the kinetics profile of one or several markers correlates strongly with the diagnosis of chorioamnionitis, it could be used in clinical practice, possibly in the context of another clinical study. the results of the study presented here are destined to be published in obstetrics journals.


Eligibility criteria:
inclusion criteria: * term between 24 and 34 wa * spontaneous rupture of the fetal membranes * singleton pregnancy * age \> 18 years exclusion criteria: * delivery within the hour following admission * hospitalisation before 24 wa or after 34 wa * hemorrhagic placenta previa or retroplacental hematoma, known auto-immune or inflammatory disease * infection with human immunodeficiency virus (hiv) * refusal to provide consent. * patients provided for in articles l. 1121-5 to l. 1121-8 and l. 1122-1-2 of the public health code (e.g.: minors, adults under guardianship, etc...)