Kornimate/medical-research-clean huggingface dataset:
memantine treatment in fragile x-associated tremor/ataxia syndrome

Conditions: Fragile X-Associated Tremor/Ataxia Syndrome; Fragile X Premutation Carriers

Summary: the purpose of this study is to determine if memantine is effective in treating symptoms of fragile x-associated tremor ataxia syndrome.


Eligibility criteria:
inclusion criteria: * fragile x premutation carrier (cgg repeat 55-200)with neurological symptoms; clinical fxtas stage 1-5 exclusion criteria: * previous reaction to memantine

Keywords: fxtas, fragile x premutation
precision of complete-arch digital implant impressions with intraoral scanning versus photogrammetry

Conditions: Edentulous Jaw

Summary: the goal of this cross-over clinical trial is to investigate the precision of digital implant impressions using an intraoral scanner and photogrammetry in obtaining complete-arch implant-supported scans. the main question\[s\] it aims to answer are: * is there a difference in precision between intraoral scans and photogrammetry in obtaining digital implant scans? * will arch perimeter and jaw type (maxilla vs. mandible) affect the precision results? procedures: at each appointment, participants existing permanent/temporary prosthesis or healing caps were unscrewed and temporarily removed for the period of the consultation appointment. scanbodies were screwed into their implants for the duration of the appointment. they underwent two types of digital implant impression procedures (five times each), including intraoral scan and photogrammetry. intraoral and extraoral photography were taken. at the end of each appointment, the scanbodies were removed, and existing bridge/healing caps were reinserted. the procedures were not painful or required any form of local anesthetic comparison group: researchers compared the precision of intraoral scanning vs. photogrammetry to see which device provided the best precision outcomes.


Eligibility criteria:
inclusion criteria: * present with a completely edentulous arch with at least four implants * have bone-level implants * intended for restoration with a screw-retained abutment-level fixed implant-supported prosthesis. exclusion criteria: * patients unable to tolerate the digital scans impressions * presented with implants other than bone-level platforms * not intended for restorations with screw-retained abutment-level fixed implant-supported prosthesis * not completely edentulous.

Keywords: edentulous/edentulism cad-cam implantology prosthetic dentistry clinical studies/trial clinical outcomes
chronic low back pain graded - exposure psychoeducation intervention

Conditions: Chronic Low Back Pain

Summary: this study will examine the effectiveness of one of two psychoeducation treatments on chronic low back pain.

this study will examine the effectiveness of one of two psychoeducation treatments on chronic low back pain. participants will be randomized to one of these two treatments.

Eligibility criteria:
inclusion criteria: * report having low back pain for more than three months and at least half the days in the past 6 months * be 18-65 years of age, * have scores higher than 37 on the tampa scale of kinesiophobia, exclusion criteria: * medical conditions other than back pain that significantly impair movement (e.g., arthritis) * confirmed/suspected pregnancy * pending litigation related to an episode of low back pain * significant impairment in vision

Keywords: chronic pain low back pain
efficacy of β-carotene biofortified maize in reducing vitamin a deficiency among children

Conditions: Vitamin A Deficiency; Low Serum Retinol

Summary: the purpose of this cluster-randomized trial is to examine whether daily consumption of β-carotene biofortified maize flour can reduce the prevalence of vitamin a deficiency and improve the vitamin a status and among 4-8 year old children in rural zambia.

vitamin a deficiency is a major public health problem in zambia, affecting approximately 40% of young children. we aim to conduct a cluster-randomised controlled trial in the mkushi region of rural zambia to test whether feeding children two daily meals containing β-carotene biofortified maize flour compared to regular white maize flour-based meals for six months can reduce the prevalence of vitamin a deficiency and improve the vitamin a status among 4-8 year old children. five hundred children in each arm will receive 2 meals a day, 6 days a week for 6 months, after which changes in serum retinol concentrations will be compared. an additional arm of 250 children, enrolled from randomly sampled clusters, will not receive the maize flour intervention but concurrently followed in order to evaluate overall effects of the maize flour feeding scheme on measures of household food security.

Eligibility criteria:
inclusion criteria: * children 4-8 years of age

Keywords: beta-carotene biofortified maize micronutrients vitamin a serum retinol dark adaptation
covid-19 convalescent plasma as prevention and treatment for children with underlying medical conditions

Conditions: Corona Virus Infection

Summary: this study will provide access to investigational anti-sars-cov-2 human convalescent plasma for pediatric patients with underlying medical conditions (cardiovascular disease, lung disease, immunosuppression) who are either infected with sars-cov-2 or who have had a high-risk exposure. study participants will be transfused once with compatible convalescent plasma obtained from an individual who has recovered from documented infection with sars-cov-2. safety information and pharmacokinetic data will be collected.


Eligibility criteria:
inclusion criteria: * age ≥ 1 month and \< 18 years at the time of consent. * determined to be at high-risk for severe sars-cov-2 disease based on the american academy of pediatrics definition of immunocompromised children and reported high-risk pediatric subpopulations. these include the following groups: immunocompromised, hemodynamically significant cardiac disease (e.g. congenital heart disease), lung disease with chronic respiratory failure, infant, i.e. child ≤1 year old. * confirmed sars-cov-2 infection or high-risk exposure as defined: * confirmed infection: child who tested positive for covid-19 and is no more than 96 hours after onset of symptoms (and within 120 hours at the time of receipt of study plasma). * high-risk exposure: susceptible child who was not previously infected or otherwise immune to sars-cov-2 and exposed within 96 hours prior to enrollment (and within 120 hours at the time of receipt of study plasma). both criteria below should be met: 1. a household member or daycare center (same room) exposure to a person with confirmed sars-cov-2 or with clinically compatible disease in areas with widespread ongoing transmission 2. negative for sars-cov-2 (nasopharyngeal or oropharyngeal swab) * for females of reproductive potential (defined as having experienced menarche), not pregnant based on testing performed at screening. * parent or legal guardian able and willing to provide signed parent permission. exclusion criteria: * history of severe reactions (e.g. anaphylaxis) to transfusion of blood products. individuals with minor reactions such as fever, itching, chills, etc. that resolve spontaneously or respond to pre-medications, and that do not represent more significant allergic reactions, will not be excluded. * for females, breastfeeding, or planning to become pregnant/breastfeed during the study period. * participant is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate outside the greater los angeles area during the study. * any condition that would, in the opinion of the principal investigator, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol.
use of the sentinel node biopsy for early endometrial cancer.

Conditions: Cancer of Endometrium

Summary: this is an obstervationnal study, to evaluate the good clinical practice of the use of the sentinel node biospy in early stage endometrial cancer. the collaborating centres with the oncogynecology board of the king albert ii institute of the clinique universitaire saint-luc will also particpate to the trial. sentinel node biospy is not yet validated for endometrial cancer, even if lots of leading team in the world published very good result and that the first prospectives trials are already published with also excellents results. the investigators decided then to include this practice in their institutional guideslines and also to registred the procedure.

all the sentinel node biopsy procedures for endometrial cancer will be record online via the redcap tools, securized on a servor in saint-luc. automatic email for the following of the patients and the post operative event will be send regularly for every patient to the physicians who include the patient. efficacy of the technique, false negative and postive rate, modifications of the adjuvant treatement, long terme evolution and complication wil be evaluate.

Eligibility criteria:
inclusion criteria: * endometrial cancer early stage on the pre operative examinations * performance status that allow a surgery * surgery by laparoscopy or laparotomy exclusion criteria: * patient already operated of the hysterectomy who need lymphatic restadification * stage iv disease
phase 1, dose escalation study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of sm04690 in moderate to severe knee osteoarthritis (oa)

Conditions: Moderate to Severe Osteoarthritis

Summary: the purpose of this study is to find the optimal dose of sm04690 that can be safely given by intra-articular injection into the target knee joint of subjects with moderate to severe osteoarthritis.


Eligibility criteria:
inclusion criteria: * diagnosed with primary oa in target knee by american college of rheumatology (acr) criteria * screening pain criteria sufficient as assessed by womac and vas scores * ability to read and understand the informed consent exclusion criteria: * women who are pregnant or lactating or child bearing potential, men must use a barrier method of contraception * any condition, including laboratory findings, that in the opinion of the investigator constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct or evaluation * body mass index \>40 * major knee surgery in the target knee within 12 months prior to study or planned surgery during the study period * history of malignancy within the last 5 years * participation in a clinical research trial within 12 weeks prior * treatment of the target knee with intra-articular steroids within 2 months or hyaluronic acid derivatives within 6 months * effusion of the target knee requiring aspiration within 3 months * use of electrotherapy or acupuncture for oa within 4 weeks * significant and clinically evident misalignment of the target knee * any known active infections * any chronic condition that has not been well controlled for a minimum of 3 months
survival of peritoneal mesothelioma after cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy (hipec)

Conditions: Peritoneal Mesotheliomas

Summary: review of the investigators hospital experience in cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy (hipec) for peritoneal mesotheliomas, using oxaliplatin as intraperitoneal chemotherapeutic agent.

observation of primary outcome: * overall survival * disease-free survival influencing factors that will be observe: * sex * blood loss * time of surgery * number of resection and anastomosis * peritoneal index (pi score) * cytoreductibility (ccr score)

Eligibility criteria:
inclusion criteria: * peritoneal mesothelioma exclusion criteria: * non resectable disease

Keywords: peritoneal mesotheliomas hyperthermic intra-peritoneal chemotherapy (hipec) oxaliplatin cytoreductive surgery oxaliplatin hipec
axis™ allograft dermis for female pelvic floor repair: a prospective post market study

Conditions: Pelvic Organ Prolapse

Summary: this study is a prospective, single arm, multi-center, post-market study to evaluate the efficacy of axis™ allograft dermis used for anterior, posterior or combined (anterior and posterior) pelvic organ prolapse repair.

the study population will be adult female patients with pelvic organ prolapse, pop-q stage ≥ 2 that are clinically indicated for surgical intervention with axis allograft dermis in the anterior, posterior or combined (anterior and posterior) compartments.

Eligibility criteria:
inclusion criteria: * adult female at least 18 years of age. * willing and able to provide written informed consent. * confirmed pelvic organ prolapse (pop) of stage 2 or higher as determined by pop-q prolapse grading requiring surgical intervention in the anterior, posterior or combined (anterior and posterior) compartment. * willing and able to complete all follow-up visits and procedures indicated in this protocol. exclusion criteria: * concurrent surgical treatment of pelvic organ prolapse using anything other than the axis dermis.\[note: concurrent mid-urethral sling placement for treatment of stress urinary incontinence is allowed\]. * confirmed stage 2 or higher prolapse as determined by pop-q prolapse grading for a compartment that is not being repaired in the same procedure. (concurrent pop-q stage 1 repair is at the physician's discretion.) * previous pelvic organ prolapse repair using biologic, or synthetic grafts. \[note: previous mid-urethral sling for treatment of stress urinary incontinence is allowed\] * pregnant or a desire to become pregnant in the future. * previous radiation or other treatments for cancer in the pelvic area. * severe urogenital atrophy. * immunosuppression and/or current systemic steroid user. * any contraindication to the surgical procedure.
treatment of post-operative pain following orthopedic surgery with sprint® peripheral nerve stimulation (pns) system

Conditions: Postoperative Pain; Total Knee Replacement; Total Knee Arthroplasty; Partial Knee Replacement

Summary: the purpose of this study is to gather information about how knee pain changes when small amounts of electricity are delivered to the nerves in the leg. this study will involve the use of a peripheral nerve stimulation (pns) system that is made by spr therapeutics (the sponsor of the study). the sprint pns system was cleared by the fda for up to 60 days of use in the back and/or extremities for the management of acute and chronic pain.


Eligibility criteria:
key inclusion criteria: * at least 21 years old * underwent a 1. primary total knee replacement (tkr), 2. secondary/revision tkr or 3. partial/unicompartmental knee replacement (pkr) * knee pain directly resulting from knee replacement surgery in affected knee key exclusion criteria: * current high opioid use * body mass index (bmi) \> 40 kg/m2 * conditions with increased risk of infection * implanted electronic device * history of bleeding or clotting disorder. * uncontrolled diabetes mellitus types i or ii * pregnancy

Keywords: pain, postoperative musculoskeletal diseases postoperative complications nervous system diseases pain neurologic manifestations signs and symptoms
dentinal hypersensitivity reduction efficacy study

Conditions: Sensitivity, Tooth

Summary: assess the clinical efficacy of cspr toothpaste containing 8% arginine to provide dentinal hypersensitivity relief

the objective of this study is to assess the clinical efficacy of cspr toothpaste containing 8% arginine to provide dentinal hypersensitivity relief (tactile and air blast) at instant, 3 days, 4 weeks and 8 weeks in comparison to colgate cavity protection toothpaste over an eight-week period.

Eligibility criteria:
inclusion criteria: * male and female subjects, ages 18-70, inclusive. * availability for the eight-week duration of the study. * two sensitive teeth, which must be anterior to the molars, and demonstrate cervical erosion/abrasion or gingival recession. * qualifying response to tactile stimuli (yeaple probe) as defined by a score between 10-50 gms. of force. * qualifying response to the air blast stimuli as defined by a score of 2 or 3 on the schiff cold air sensitivity scale. * subjects need to satisfy the qualifying response to stimuli for both the parameters assessed (tactile or air) on two teeth to be entered into the study. * good general health with no known allergies to products being tested. * use of a non-desensitizing dentifrice for three months prior to entry into the study. * signed informed consent form. exclusion criteria: * gross oral pathology, chronic disease, or history of allergy to test products. 2. advanced periodontal disease or treatment for periodontal disease (including surgery) within the past twelve months. * sensitive teeth with a mobility greater than one. * teeth with extensive/defective restorations (including prosthetic crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures. * current use of anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory drugs, or daily use of analgesics. * participation in a desensitizing dentifrice study or regular use of a desensitizing dentifrice within the past three months. * current participation in any other clinical study. * pregnant or lactating subjects. * allergies to oral care products, personal care consumer products, or their ingredients. * medical condition which prohibits not eating/drinking for 4 hours.

Keywords: hypersensitivity dentin
cyberknife radiosurgery for localized prostatic carcinoma

Conditions: Prostate Cancer

Summary: virtual high dose rate (hdr) cyberknife (ck) prostate treatment has comparable morbidity and efficacy compared with actual prostate hdr treatment, but does it without the catheters and hospital admission. as such, it is a more "patient friendly" treatment method compared with actual prostate hdr brachytherapy as currently practiced. related, as has previously been reported with actual prostate hdr treatment, virtual hdr cyberknife prostate treatment should have a high efficacy but with lower acute and chronic morbidity compared with other local prostate cancer treatment methods such as permanent seed prostate brachytherapy.

brachytherapy is a form of treatment where a radioactive isotope is implanted directly into a tumor volume to deliver a lethal dose of radiation. high dose rate (hdr) prostate brachytherapy is a particularly elegant brachytherapy dose sculpting method that is effectively used in the curative treatment of prostate cancer; however, it requires hospital admission and many temporarily implanted transperineal catheters to deliver the radiation source to the target volume, resulting in significant patient discomfort. cyberknife delivers a form of radiation treatment that is so precise, it appears capable of reconstructing hdr prostate radiation dose sculpting, without the hospital admission and without the catheters. the cyberknife device is also used for classic radiosurgery, with accuracy comparable to the gamma knife, but unlike the gamma knife, has the capability to target lesions anywhere in the body with similar accuracy. the aim of this study is to compare cyberknife morbidity and efficacy with that of hdr and other local treatment methods such a permanent seed prostate brachytherapy in the treatment of prostate cancer.

Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the prostate, clinical stage t1b - t2b (ajcc 6th edition, see appendix ii), nx/n0, m0. * karnofsky performance status \> 80. * patient must be ≥ 18 years of age. * gleason sum \< or = 7 * prostate-specific antigen \< or = 20 ng/ml * patients must sign a study-specific informed consent form prior to study entry. exclusion criteria: * stage \< t1b, t2c, t3 or t4 disease (ajcc 6th edition, see appendix ii). * gleason score \> 7. * psa \> 20 ng/ml. * lymph node involvement (n1). * evidence of distant metastases (m1). * radical surgery for carcinoma of the prostate, prior pelvic radiation, pelvic surgical clips or other metallic foreign bodies. * history of hormonal therapy (antiandrogen or 5 alpha reductase treatment within three months prior to treatment). * previous or concurrent cancers other than basal, in situ, or squamous cell skin cancers unless disease-free for ≥ 5 years. * major medical or psychiatric illness, which in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up. * metallic hip prosthesis. * history of inflammatory bowel disease

Keywords: prostatic cancer prostatic neoplasms prostate neoplasms cancer of the prostate
extended follow-up of the iss t-003 trial volunteers (iss t-003 ef-up2020)

Conditions: HIV Infections

Summary: a further extension of the follow-up of the volunteers of the iss t-003 trial is being conducted in order to evaluate the persistence of vaccine immunogenicity as well as of the immunological and virological effects induced by the therapeutic immunization with tat after about 10 years from vaccination.

the volunteers enrolled in the south african iss t-003 trial (clinicaltrials.gov nct01513135; sanctr: doh-27-0211-3351) were recently enrolled in an observational study to extend the follow-up of the trial. the results of this study (iss t-003 ef-up, clinicaltrials.gov nct02712489; sanctr: doh-27-0615-4948) indicate the maintenance of anti-tat ab in a vast proposition of vaccinees. the new roll-over observational study (iss t-003 ef-up2020; sanctr: doh-27-072022-7347) is to be conducted to further extend the follow-up of the participants of the iss t-003 trial in order to evaluate the persistence of vaccine immunogenicity as well as of the immunological and virological effects induced by the therapeutic immunization with tat after about 10 years from vaccination. to this aim volunteers of the iss t-003 study are included in a new 6-months study, with visits at weeks 0 and 24, during which the persistence and levels of anti-tat antibodies (primary endpoint) and the cd4+ t-cell and hiv-1 plasma viraemia levels (secondary endpoint) will be evaluated. in addition, depending on the availability of residual specimens (pbmc, serum and plasma), further laboratory tests will be performed to investigate in-depth the immunological and virological profile of the volunteers. clinical signs and symptoms of disease progression and aids-defining events will also be recorded.

Eligibility criteria:
inclusion criteria: * previous participation in the iss t-003 ef-up study without withdrawal of consent; * availability to participate in the ensuing extended follow-up study; * signed informed consent. exclusion criteria: * the absence of any of the above criteria will exclude the participants from the study.

Keywords: hiv haart-treated participants tat protein therapeutic immunization