Kornimate/medical-research-clean huggingface dataset:
chlorhexidine mouthrinses and plaque control

Conditions: Dental Plaque

Summary: the aim of the present study was to compare antiplaque effectiveness of two commercial mouthrinses: 0.12 % chlorhexidine alcohol base (clx-a) versus a diluted 0.1% chlorhexidine non-alcohol base with 0.1% of formaldehyde (clx-f).

chlorhexidine (clx) mouthrinse has been the gold standard as antiplaque solution.however, if its efficiency seems to be preserved even if the chlorhexidine concentration is bellow 0.10%, the formulation of the final product may affect the effectiveness. thus, it can be concluded from this study that 0.12% clx alcohol base mouthrinse is significantly more effective in inhibiting plaque than the diluted 0.1% clx non-alcohol base containing formaldehyde mouthrinse.

Eligibility criteria:
inclusion criteria: * give written informed consent before entering the study * accept to stop tooth cleaning for a week exclusion criteria: * less than 20 teeth; * presence of periodontal disease * presence of factors of plaque retention (clinically unacceptable restorations, important carious, dental overlapping, removable prosthesis, faulty fixed prosthesis, orthodontic appliances), * associated systemic diseases (diabetes, heart disorders, blood diseases, hiv infection), * use of antibiotics or other anti-inflammatory drugs during the latest months, * known allergy against components of mouth rinses, * pregnancy, * smoking

Keywords: chlorhexidine mouthrinse plaque control
sun may arise on sma : newborn screening of spinal muscular atrophy in belgium

Conditions: Spinal Muscular Atrophy

Summary: medico-economic study of newborn screening of spinal muscular atrophy

the aim of this project is to demonstrate the feasibility and the medico-economic impact of a spinal muscular atrophy neonatal screening in a european country. we propose a 3-year-neonatal screening program in southern belgium (wallonia-brussels federation) where there is 59.000 newborns/year, among whom 6 are affected by spinal muscular atrophy.

Eligibility criteria:
inclusion criteria: * all newborns in southern belgium exclusion criteria: * newborns whose parents refuse screening

Keywords: newborn screening
patient controlled epidural analgesia versus intravenous patient controlled analgesia for post-operative pain control in patients undergoing elective liver resection

Conditions: Liver Cancer; Pain Management

Summary: the purpose of this study is to learn whether patient-controlled epidural analgesia (pcea) is a better method for managing pain after liver resection compared to patient-controlled analgesia (iv pca). currently, the standard pain control method for liver resection patients is iv pca. there is not enough data on how epidural (pcea) relieves pain and movement on a day to day basis after liver resection.


Eligibility criteria:
inclusion criteria: * adults (age 18 years or older) who are able to provide informed consent. * patients undergoing open elective liver resection for primary liver pathology (benign or malignant) or secondary metastatic liver disease, including patients undergoing concomitant surgical procedures (such as colorectal resection or debulking procedures), with no contraindication to the insertion of an epidural catheter (localized infection, septicemia, or pre-operative coagulopathy). exclusion criteria: * patients with a history of documented anaphylaxis or contraindication to any of the study medications or standardized intra-operative medications. these include dilaudid, fentanyl, and bupivacaine. * patients with pain at rest or with movement measured by nrs \>2. * patients receiving high dose opioids on a chronic basis (greater than or equivalent to 60mg of morphine per day). * patients with severe chronic obstructive pulmonary disease (copd) defined as an fev1 \<50%. * patients with significant cognitive impairment or documented psychologic impairment. * contraindication to epidural catheter placement including bleeding diathesis (essential thrombocythemia, idiopathic thrombocytopenic purpura, von willebrand disease, and hemophilia a or b), neurological dysfunction (multiple sclerosis, subacute myelo-opticoneuropathy or preexisting lower limb neurological deficit), prior extensive spinal surgery or major spinal deformity, pre-operative use of anti-coagulant with planned use of therapeutic dose of anti-coagulant in post-operatively, documented pre-operative coagulopathy (inr greater than 1.3 not on coumadin or ptt greater than 42), platelets less than 100,000/μl, or evidence of infection at potential epidural site. * cirrhotic patients. when incidentally discovered intra-operatively, patients will be excluded from the study and replaced, but will be followed for primary and secondary endpoints. * patients with poor performance status preoperatively such that they are unable to walk up two flights of stairs. * patients taking any opioid agonist/antagonist medication (i.e. buprenorphine)

Keywords: epidural analgesia intravenous patient controlled 15-148
using circulating tumor dna to personalize duration of consolidation durvalumab

Conditions: NSCLC, Stage III

Summary: this research aims to incorporate ctdna analysis into clinical practice to individualize therapy in patients with stage iii nsclc by moving to a treatment-by-marker based approach (as opposed to treatment based on clinical or radiographic evidence of disease).

there is a critical need to identify mrd to determine which patients benefit from checkpoint inhibitor therapy and to optimize and personalize the duration of consolidation durvalumab. the long-term goal is to incorporate ctdna analysis into clinical practice to individualize therapy in patients with stage iii nsclc by moving to a treatment-by-marker based approach (as opposed to treatment based on clinical or radiographic evidence of disease). this approach may spare a subset of patients from treatment with unnecessarily excessive cycles of consolidation immunotherapy if they are already cured with crt alone and individualize the duration of consolidation immunotherapy in patients not cured with crt. the study team also seek to identify early in the treatment course, patients who are destined not to be cured with consolidation immunotherapy so that alternative strategies can be tested when tumor burden is low.

Eligibility criteria:
inclusion criteria: age ≥ 18 years ability to provide written informed consent and hipaa authorization patients with inoperable or unresectable stage iii nsclc who are planning to receive concurrent crt followed by consolidation durvalumab or patients with inoperable or unresectable stage iii nsclc who have previously received concurrent crt and are planning or currently receiving c1-4 consolidation durvalumab must have viable tissue for ctdna profiling, (fresh or archived tissue) exclusion criteria: patient unwilling to provide tissue and blood samples for ctdna testing. patient has contraindications to treatment with concurrent crt and/or consolidation durvalumab. patients with any other active cancer; excluding squamous cell or basal cell cancer.
temozolomide in treating patients with metastatic germ cell tumors that have not responded to cisplatin

Conditions: Ovarian Cancer; Testicular Germ Cell Tumor

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of temozolomide in treating patients who have metastatic germ cell tumors that have not responded to cisplatin.

objectives: i. determine the efficacy of temozolomide in patients with cisplatin refractory metastatic germ cell tumors. ii. determine the safety of this treatment in these patients. outline: patients receive oral temozolomide on days 1-5. treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. projected accrual: a total of 14-25 patients will be accrued for this study over 25 months.

Eligibility criteria:
disease characteristics: histologically confirmed metastatic germ cell tumor seminoma or nonseminoma measurable disease abnormalities on radiograph or alpha fetoprotein greater than 15 ng/ml or beta human chorionic gonadotropin greater than 2.2 miu/l at least one measurable disease site that has not received prior radiotherapy refractory to prior cisplatin and failed, not eligible for, or refused autologous bone marrow transplantation patient characteristics: age: 16 and over performance status: karnofsky 70-100% life expectancy: at least 3 months hematopoietic: wbc at least 3,000/mm3 absolute neutrophil count at least 1,000/mm3 platelet count at lest 80,000/mm3 hemoglobin at least 10 g/dl hepatic: bilirubin no greater than 1.5 times normal transaminases no greater than 1.5 times upper limit or normal (uln) alkaline phosphatase no greater than 3.0 times uln renal: creatinine no greater than 1.5 times uln other: no medical conditions that would interfere with swallowing or cause excessive vomiting no second malignancy except basal and squamous cell skin cancer not pregnant or nursing negative pregnancy test fertile patients must use effective barrier contraception prior concurrent therapy: biologic therapy: see disease characteristics chemotherapy: see disease characteristics endocrine therapy: not specified radiotherapy: see disease characteristics surgery: not specified

Keywords: stage iii malignant testicular germ cell tumor recurrent malignant testicular germ cell tumor stage iv ovarian germ cell tumor recurrent ovarian germ cell tumor
acetylsalicylic acid combined with pseudoephedrine in common cold

Conditions: Common Cold

Summary: the purpose of the study is to determine the effectiveness of an acetylsalicylic acid (aspirin) pseudoephedrine combination for the treatment of pain and congestion symptoms compared to the effectiveness of the individual components of the medicine and the placebo (dummy treatment that looks like the real thing).the combination product of acetylsalicylic acid / pseudoephedrine is already marketed in several european countries as aspirin® complex.


Eligibility criteria:
inclusion criteria: * patient in general good health with suspected viral upper respiratory tract infection (common cold) exclusion criteria: * \< 18 years old

Keywords: aspirin complex acetylsalicylic acid pseudoephedrine common cold
a study of intrathecal hydromorphone for pediatric idiopathic scoliosis repair

Conditions: Pain Control

Summary: the purpose of this study is to identify a dose of intrathecal hydromorphone (opioid pain medicine) that optimizes pain control but minimizes side effects historically seen with this class of pain medications.

this study is a sequential coin based up-down dose allocation method with the goal of identifying the ed90 for intrathecal hydromorphone (ith) in idiopathic adolescent scoliosis repair via the posterior approach. a starting dose of 3.5 mcg/kg of hydromorphone was determined by current practice at the institution as well as upon review of available literature of previously used itm doses in pediatric spine patients. subsequent participants will receive higher (step "up") or lower (step "down") from this starting dose. steps "down" from the starting dose will be smaller than steps "up" to ensure maintenance of adequate analgesia and to allow more accurate estimate of the optimal dose should it decrease beyond our starting dose. steps "up" from the starting dose were chosen based on commonly used weight-based doses in our current practice. a maximum dose of 400 mcg, despite patient weight, was determined based on expert consensus and review preparatory to research query. the anesthesiologist covering the case (high lumbar or thoracic corrections) or the surgeon (low lumbar corrections) will administer the medication at the low lumbar level. ith dose adjustments for subsequent study patients will be based on the efficacy of the dose used with the prior patient. efficacious ith administration will be defined as all nrs scores ≤5 within the first 18 hours after administration (binary outcome). if the nrs score was \>5 within 18 hours or if the patient required supplemental opioid administration for pain control (suggestive of insufficient analgesia), the dose will be increased for the next enrolled study patient. if the pain score remains ≤5 within 18 hours of opioid administration, the next patient will receive the next lower dose or the same dose as the previous patient. patients excluded after randomization will be removed from the study.

Eligibility criteria:
inclusion criteria: - undergoing spinal surgery with a posterior approach for idiopathic scoliosis. exclusion criteria: * patients with pre-surgical elevated pain scores (≥ 3/10 on numeric rating scale (nrs)), history of chronic pain, or pre-surgical opioid use will not be included. * patients with contraindications to spinal anesthesia (anatomical abnormality or elevated bleeding or infection risks) will not be included. * patients for whom the protocol is violated (inability to perform postoperative data collection), or the study/procedure was aborted will not be included in analysis.

Keywords: posterior spine surgery pediatric idiopathic scoliosis repair
sensory motor integration training in erb's palsy childern

Conditions: Sensory Motor Integration and Erb's

Summary: the aim of the study is to study effect of sensory motor integration training on adl activities in children with erb's palsy.

thirty-two participants , their age ranged from two to six years for both genders (sixteen children treated with designed occupational therapy program group a and sixteen treated with designed occupational therapy program and sensory motor integration training group b )

Eligibility criteria:
inclusion criteria: 1. their ages will be ranged from 2 to 6 years in both sexes. 2. the infants with erb's palsy (c5-c6). 3. can follow verbal commend 4. muscle tone within normal and muscle power within functional range. 5. intact vision and hearing. exclusion criteria: 1. children undergoing surgical treatment. 2. cognitive problem and cognitive anomalies. 3. children with erb's engram. 4. complete sensory loss. 5. shoulder subluxation or dislocation.

Keywords: erb's palsy -sensory motor integration - adl- bimanual hand use
evaluation of emotional disorders during treatment by interferon beta in relapsing-remitting multiple sclerosis patients

Conditions: Multiple Sclerosis, Relapsing, Remitting

Summary: this study is planned to evaluate emotional disorders during treatment by interferon (ifn) beta in relapsing remitting multiple sclerosis (rrms) subjects. this is an open-label exploratory study with no change of therapeutic behavior but with standardized neuropsychologic follow-up.

this study is planned to evaluate emotional disorders during treatment by ifn beta in rrms subjects. this is an open-label, prospective, interventional, multicentric study with no change of therapeutic behavior but with standardized neuropsychologic follow-up. subjects will undergo 13 evaluations (categorical and dimensional evaluations), 3 evaluations will be performed before the treatment (baseline, day 7 and 15) and 10 evaluations after the treatment (month 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24).

Eligibility criteria:
inclusion criteria: * male and female subjects aged ≥ 18 years * subjects with rrms * subjects with at least 2 relapses in the past two years (with last relapse finished or finishing) * subjects with indication of ifn beta treatment determined by the investigator * other protocol-defined inclusion criteria may apply exclusion criteria: * subjects with secondary progressive multiple sclerosis (ms) without relapse * subjects with ongoing acute relapse * subjects already being treated with interferon * subjects with corticoid therapy for less than 15 days * subjects presenting acute major depression or treated with anti-depressant therapy * subjects involved in another therapeutic study * subjects with any condition which could interfere with a good compliance of this study * other protocol-defined exclusion criteria may apply

Keywords: multiple sclerosis, relapsing, remitting interferon-beta
a trial of one to one weight management in primary care

Conditions: Obesity; Overweight

Summary: the purpose of this study is to conduct a randomised controlled trial to assess the sustained effects on weight, selected risk factors and sense of well-being of offering individualized weight management advice in the primary care setting to patients who wish to lose weight; and to identify the key factors influencing the success of the intervention.

primary care could make a substantial impact on the increasing prevalence of overweight and obesity and their associated adverse impact on health. the lack of a proven intervention may deter health professionals in primary care from providing support to their overweight patients as few obese people recall receiving weight control advice from a health professional. in this study we aim to conduct a large scale randomised controlled trial to assess the effectiveness of a longer-term structured lifestyle support programme provided by a research nurse and the provision of pedometers compared to usual care in overweight/ obese adults who wish to lose weight. we will assess the degree of weight loss over a period of 12 months as well as related factors such as changes in waist circumference, quality of life and cost-effectiveness of the interventions. the research is highly relevant to policy making at both national and local levels.

Eligibility criteria:
inclusion criteria: * 18 years or over * bmi ≥ 25 kg/m2 * gp confirmation exclusion criteria: * pregnant or lactating women * patients with renal failure, pacemakers or cancer * participating in other research affecting weight * ability to complete questionnaires * ability to give consent

Keywords: obesity overweight randomised controlled trial primary care weight cardiovascular risk diabetes quality of life
prevalence of the hyperventilation syndrome in pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: dyspnea is a major symptom in pulmonary arterial hypertension and people with the same haemodynamic have generally different degree of dyspnea in pulmonary arterial hypertension. the hyperventilation syndrome is a frequent cause of dyspnea in general population and in respiratory diseases like asthma but has never been studied in pulmonary hypertension. the goal of this study is to measure the prevalence of pulmonary hypertension in a population of patients with controlled pulmonary arterial hypertension (pah).

hyperventilation syndrome has been described as a cause of dyspnea in the general population and in several chronic respiratory diseases such as asthma with 20 to 40% of asthmatics affected. however, hyperventilation syndrome has never been sought in a population with pah. hyperventilation syndrome, although complex pathophysiology, may be simply corrected by a management of respiratory physiotherapy based on the control of respiration.

Eligibility criteria:
inclusion criteria: * non smoker or tobacco stopped for minimum 2 years ans maximum 10 year-pack. - idiopathic, heritable, related to drug or toxics, associated with controlled pulmonary hypertension. diagnosis and treatment of pulmonary hypertension for more than 4 months. * optimal control of pulmonary hypertension (no right heart failure symptom and ntprobnp \ 2,5 l/min/m2, veinous saturation in oxygen \> 65%) * informed and written consent * non-affiliation to a social security exclusion criteria: * existence of another form of pulmonary hypertension * existence of vocal cord dysfunction * pregnancy * obesity\> stage 2 (bmi 35 kg / m2) * age ≥ 75 years

Keywords: hyperventilation
study to evaluate safety and efficacy of ub-421 antibody in hiv-1 infected adults

Conditions: HIV-1 Infection in Adults

Summary: the purpose of this phase iia study is to determine whether the antibody (ub-421), targeting the hiv-1 receptor on the cd4 molecule of t-lymphocytes and monocytes, is safe and effective when multiple doses are administered by intravenous infusion to asymptomatic hiv-1 infected adults and to assess pharmacokinetic parameters of the antibody in blood and on cells. the neutralizing activity of ub-421 blocks hiv-1 from binding to its receptor on cd4-positive cells; thus, ub-421 functions as an immunotherapeutic intervention to prevent hiv-1 infection.


Eligibility criteria:
inclusion criteria: * asymptomatic, treatment-naive, hiv-1 seropositive * cd4+ t cell count \>350 cells/cubic millimeter * hiv-1 viral load \>5,000 copies/ml * other inclusion criteria apply exclusion criteria: * active infection requiring immediate therapy (except hiv-1) * previous exposure to monoclonal antibody (including ub-421) * prior participation in any hiv vaccine trial * use of immunomodulating drugs or systemic chemotherapy * other exclusion criteria apply

Keywords: hiv-1 cd4 antibody immunotherapy
a water training program to improve balance in chronic stroke patients

Conditions: Chronic Stroke Patients

Summary: the proposed project is a case control study design. subject's suffer from stroke willing to participate in the study will be shortly interviewed to assess eligibility according to the inclusion-exclusion criteria. subjects suffer from chronic hemiplegia that upon questioning was judged to meet the following inclusion criteria: (a) able to stand independently 90 seconds; (b) able to walk 10 meters (with cane if necessary); (c) able to understand verbal instructions. the exclusion criteria will be: (a) serious visual impairment; (b) inability to ambulate independently (cane acceptable, walker not). (c) severely impaired cognitive status (score less then 24 in mini mental state examination). (d) persons with impaired communication capabilities. the whole project will be conducted over a period of 3 months. a total of 36 subjects will be assigned to water based exercise program. the exercise group will meet on 24 occasions over a period of 12 weeks (2 times/week). the subjects of the exercise group will be recruited from sha'ar ha'negev swimming pool and from patients that get a physical therapy treatment kupat holim clalit. gait and balance function will be tested in both groups with well established measuring techniques before and after the training period. the measuring techniques 1) medical background variables. 2) berg balance scale. 3) late life function and disability instrument. 4) get up and go test - stand up and walk 3 meters turn around and walk back to the chair. 5) step execution test under single and dual task; 5) stability tests. 6) also fall will be monitored a year after the completion of the study. the water training intervention is performed on different levels where each level reflects different increasing demands on the postural control system. for example, the instructor can increase the difficulty of a certain water-exercise by instructing a participant to use less external support, close the eyes, decrease the support area (stand on one leg or narrow the stance, or on unstable surface). these "tools" allow the instructor to implement step exercises on a group level that are still challenging for each individual even if the skill level in the group varies. the water exercises also include perturbation exercises that trigger specific reflex-like balance responses. on each level the instructor can instantly modify an exercise to be more or less challenging for each participant.


Eligibility criteria:
inclusion criteria: 1. subjects suffer from chronic hemiplegia (a year or more) 2. able to stand independently 90 seconds; 3. able to walk 10 meters (with cane if necessary); 4. able to understand verbal instructions. exclusion criteria: 1. serious visual impairment; 2. inability to ambulate independently (cane acceptable, walker not). 3. severely impaired cognitive status (score less then 24 in mini mental state examination). 4. persons with impaired communication capabilities.

Keywords: balance water based training physical functioning stepping behavior