Kornimate/medical-research-clean huggingface dataset:
evaluating a social and communication intervention for preschoolers

Conditions: Autism Spectrum Disorder

Summary: the purpose of this study is to test the effectiveness of a school-based treatment aimed at increasing language and social skills in preschool-aged children with autism spectrum disorder (asd). through interactive development (continually seeking educator feedback for intervention improvement) and implementation of the intervention, the investigators hope to provide a feasible and practical means for educators to work with children with asd in real world, large scale settings. asd preschool educators, the children enrolled in their classes, between the ages of 3 and 6 years and their families may join.

in phase 4, kki staff trained delaware preschool teachers to serve as model coaches and educators through the delaware autism program. families whose children were enrolled in participating classrooms were consented through dap using the school's consent to be videotaped. any families who did not consent for their child to be videotaped for this training received the nonparticipant consent form currently utilized in this study and staff videotaping took every effort to keep those children out of frame when taping. this cohort involved kki study team members training 1-2 coaches, who then trained five delaware school teachers. the ies model was implemented in the teacher's classrooms (n= 5-10 students participating in each classroom; 20-40 children total). in the current phase of the study, phase 5 and 6, kki study team members will continue the evaluation of the ies model, by testing the efficacy of the intervention model in a larger sample (phase 5) and then analyzing the corresponding data (phase 6). the larger efficacy study (phase 5) will be conducted on teachers and students recruited from public school districts in maryland, delaware, and pennsylvania using the same ies model and recruitment methods in the previous phases.

Eligibility criteria:
inclusion criteria: for teachers: - work in an asd preschool classroom within a cooperating baltimore county public school. for children: * meet autism diagnostic observation schedule-generic (ados; lord et al., 2002) and expert clinical judgment criteria for asd * have an iq or developmental quotient of at least 40 based on the early learning composite from the mullen scales of early learning (mullen, 1995) * be enrolled in a participating baltimore county public school asd preschool classroom * be between the ages of 3 and 6 and enrolled in a participating asd preschool classroom. exclusion criteria: children and educators may be taken out of the study if they: * are unable to comply with the study protocol * change schools due to relocation children may also be taken out of this study if they: * sustain a head injury or other serious physical injury during the study * are not being brought in for testing as designated in the protocol

Keywords: autism spectrum disorders school language social
vitamin d3 treatment and homocysteine concentrations among overweight reproductive women

Conditions: Homocystinaemia; Vitamin D Deficiency

Summary: 100 overweight reproductive vitamin d deficient women were divided into two groups; vitamin d (n = 50) and placebo (n = 50). vitamin d group received treatment dose of 50,000 iu of vitamin d3 per week for 2 consecutive months and placebo group received placebo tablets similar in size, shape and color to vitamin d3 for 2 months also. total homocysteine concentrations were measured before intervention (basal), on 30 days (one month) and on 60 days (2 months) of intervention. changes in means of homocysteine concentrations for placebo and vitamin d group over time showed significant difference on 30 and 60 days of intervention. mean comparisons of homocysteine concentrations and standard error of the means before and after intervention showed statistical significant decrease in homocysteine concentrations among vitamin d group.


Eligibility criteria:
inclusion criteria: * overweight (bmi between 25-29.99 kg/m2) * had 25(oh)d \< 20 ng/ml * had normal vitamin b-12 and folic acid levels * not diagnosed with any chronic diseases * agreed to participat in the study exclusion criteria: * age \ 49 years * bmi \> 30 kg/m2 or \< 25 kg/m2 * 25 (oh)d level \> 20 ng/ml * thcy levels greater than 100 µmol/l * abnormal vitamin b-12 or folic acid levels * chronic diseases * pregnant or lactating

Keywords: homocysteine overweight vitamin d3 reproductive women rct
observational study of interstitial glucose monitoring with continuous glucose monitoring to track patients treated with exenatide

Conditions: Diabetes Mellitus Type 2

Summary: approximately 30 adults will participate in this study at the international diabetes center (idc). the idc is the only site conducting this study. length of participation can range from two to three months which will include four to seven clinic visits. the purpose of this study is to use a continuous glucose monitoring (cgm) system to determine the characteristics of glucose control and patterns of food intake before exenatide is started, during the start and adjustment of exenatide and during exenatide treatment. the long-term purpose of this study is to determine to what extent continuous glucose monitoring improves or alters clinical decision making for patients treated with exenatide. and, the study will also compare cgm to conventional self-monitored blood glucose methods. the study will also compare subjects' changes, if any, in nutrient intake such as energy, protein, fat and carbohydrate during the course of the study through interpretation/analysis of self-reported food intake.


Eligibility criteria:
inclusion criteria: * male or female (if of child-bearing age must practice appropriate birth control such as tubal ligation, oral contraceptives, abstinence or vasectomized partner during the duration of the study) * previously diagnosed with type 2 diabetes * age 21 and older * treated with metformin, a sulfonylurea, a thiazolidinedione, a combination or metformin and a sulfonylurea, or a combination of metformin and a thiazolidinedione (approved fda indications) * hba1c 7.1-11%, unless subject has been using exenatide prior to study; in that case, there is no restriction on hba1c level. * willing to give informed consent * motivated and capable of following the protocol and instructions provided by the healthcare professional * available for the study on the scheduled visit days * access to telephone communications exclusion criteria: * under 21 years of age * pregnancy * creatinine clearance \<30 ml/min (using mdrd formula) * known gastrointestinal disease * without diabetes or known type 1 diabetes * unable to follow the study protocol * unable to read and write in english * allergy to adhesives * any concomitant medical condition that would likely affect the evaluation of cgm device performance as determined by the investigator such as dermatological conditions or myxedema.

Keywords: type 2 diabetes continuous glucose monitoring exenatide exenatide use
the study of cm310 in patients with atopic dermatitis

Conditions: Moderate-to-severe Atopic Dermatitis

Summary: this is an open, multicenter, extension study evaluating the safety and efficacy of cm310 for long-term treatment in patients with atopic dermatitis the primary objective is to assess the long-term safety of cm310 administered in patients with atopic dermatitis (ad).

the secondary objective of the study is to assess the immunogenicity of cm310 in patients with ad, in the context of re-treatment, and to monitor efficacy parameters associated with long-term treatment.

Eligibility criteria:
inclusion criteria: 1. participation in a prior clinical trial of cm310 for ad(cm310ad001 and cm310ad002) and met one of the following: 1. participation in cm310ad001:received study treatment and adequately completed the assessments and completed the eos(d85±7) visit. 2. participation in cm310ad002 and met one of the following：i: received study treatment and adequately completed the assessments and completed the eos(v12) visit. ii:treatment termination due to other reasons other than poor compliance or ae related to cm310 , completed the eos visit . 2. provide signed informed consent exclusion criteria: 1. patients who, during their participation in a previous cm310 clinical trial, developed a sae/ae deemed related to dupilumab\*, which in the opinion of the investigator or of the medical monitor could not suitable to continue the treatment with cm310. 2. not enough washing-out period for previous therapy. 3. pregnancy. 4. other

Keywords: atopic dermatitis
tolerability of sifrol® in ambulatory patients suffering from parkinson's disease

Conditions: Parkinson Disease

Summary: study to obtain information about the co-operation of the different physician-colleagues in the treatment of patients with parkinson's disease, both in private practices and clinics and about the primary treatment strategies in the pharmacotherapy of parkinson's disease and to collect data on the tolerability of sifrol® in ambulatory patients suffering from parkinson's disease under routing conditions


Eligibility criteria:
inclusion criteria: * patients with parkinson's disease who present to the specialist neurologist practice for the first time without or with referral and who are planned to receive or either be switched to sifrol or continue the previously prescribed therapy with sifrol® can be included in this observational study exclusion criteria: * neurologists are asked to consider the summary of product characteristics (spc) for sifrol®
open versus laparoscopically-assisted esophagectomy for cancer

Conditions: Esophageal Cancer

Summary: to compare laparoscopically-assisted gastric mobilization versus open gastric mobilization in ivor-lewis esophagectomy for esophageal cancer, with open thoracic approach in the 2 arms.

open versus laparoscopically-assisted esophagectomy for cancer

Eligibility criteria:
inclusion criteria: * squamous cell or adenocarcinoma of the thoracic esophagus t1, t2, t3, n0-n1, m0, before any treatment * middle or lower third esophageal carcinoma, junctional tumor siewert type i * patients who underwent or not neoadjuvant chemotherapy or chemoradiation * tumor deemed to be resectable in a curative intent at the preoperative setting * age less than 75 years old, oms status 0, 1 or 2 * patient who can undergo one or the other surgical modality * written informed consent form * possible follow-up exclusion criteria: 1. general criteria: po2 ≤ 60 mmhg; pco2 \> 45 mmhg; fev ≤ 1000 ml/sec * hepatic cirrhosis * recent myocardial infarction (in the previous 6 months) or progressive coronary disease * distal arteritis (leriche-fontaine stage ii upwards) * concomitant cancer, other than subcarinal esophageal cancer 2. disease-related factors * invasion of subclavicular lymph nodes in a clinical examination or on biospy * lymph nodes near the origin of the celiac artery with a diameter ≥ 1 cm on ct or that appear to be suspect on endoscopic ultrasound (to differentiate them from the paracardial or left gastric lymph nodes, which does not constitute an exclusion criterion) * recurrent nerve palsy * evidence of extension to the tracheobronchial tree * signs of mediastinal invasion (vertebral contact, aortic contact ≥ 90°, or invasion of nonresectable neighboring organs such as the aorta, trachea, main bronchi, etc.) * distant metastasis 3. laparoscopy-related factors * patient presenting a general contraindication to laparoscopy * a history of median or subcostal laparotomy

Keywords: esophagus cancer surgery laparoscopy randomized trial esophageal cancer deemed to be resectable
sequential use of teriparatide and raloxifene hcl in the treatment of postmenopausal women with osteoporosis

Conditions: Osteoporosis, Postmenopausal

Summary: the purpose of this study is to determine whether the increase in spine bone mineral density that has been generally observed in previous clinical studies involving the study drug can be maintained or even increased if followed with raloxifene hcl. all qualifying study participants will receive the study drug followed by treatment with raloxifene hcl or placebo. all study participants will receive raloxifene hcl in the third phase of the study.


Eligibility criteria:
inclusion criteria: * must be diagnosed with osteoporosis * must be female, age 55 through 80 * must be at least 5 years postmenopausal * must be free of other severe or chronically disabling conditions * must be able to properly use injection device. exclusion criteria: * must not have bone diseases other than osteoporosis * must not have history of certain cancers * must not have certain medical diseases (inflammatory bowel disease, malabsorption syndrome, kidney or bladder stones, venous thrombi or emboli, recent vaginal bleeding due to unknown causes) * must not have treatment with particular medications (warfarin, estrogens, androgens, steroids, calcitonins, fluorides, biphosphonates) * must not have known allergy to the study agent or raloxifene hcl
beet pah: a study to assess the effects of beetroot juice in patients with pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: the study is a single center randomised, double-blind, placebo-controlled crossover study to assess the effects of beetroot juice in patients with pulmonary arterial hypertension.


Eligibility criteria:
inclusion criteria: * pah (pulmonary arterial hypertension) * who functional class ii-iii exclusion criteria: * who functional class i or iv * pregnancy * known intolerance or allergy to beetroot * treatment with allopurinol * treatment with iloprost (inhaled) * systolic bloodpressure \< 95 mmhg * diabetes mellitus type 2
mediators and moderators of a web-based intervention for alcohol use

Conditions: Alcohol Drinking

Summary: background: alcohol use among college students causes health and social problems. however, even when available, many students do not access alcohol interventions. web-based personalized normative feedback (pnf) has been used to disseminate alcohol brief-interventions, and evidence supports pnf efficacy in reducing alcohol consumption among this population. on the other hand, studies on pnf mediators and moderators are scarce, limiting the knowledge on the mechanisms of change and conditions in which their effects occur. objective: to evaluate whether normative perceptions mediate, and motivation to receive the intervention, moderates the effects of a web-based pnf intervention (pesquisa universitária sobre bebidas - pub 2.0) for alcohol use among brazilian college students. methods: pragmatic randomized controlled trial among college students aged 18 and over and with follow-up assessments after 1, 3 and 6 months. participants will be randomized into a control group (assessment only) or to receive the updated version of the intervention (pub 2.0). outcomes are the typical number of drinks (primary outcome) and the total number of drinks consumed, drinking frequency, maximum number of drinks consumed and number of consequences (secondary outcomes). statistical analyses will consider structural equation models and significance level of 5%. this study will improve knowledge on how and in which conditions a web-based alcohol pnf effects occur, helping tailor future strategies to reduce the impact of alcohol problems among college students.


Eligibility criteria:
inclusion criteria: * college student * alcohol use during the last year * aged 18 or more years
a randomized controlled clinical trial with orphans and widows who experienced the rwandan genocide

Conditions: Posttraumatic Stress Disorder; Depression; Prolonged Grief Disorder

Summary: in the framework of the epidemiological study, local psychologists are trained in butare in carrying out diagnostic interviews with orphans and widows who experienced the rwandan genocide. with the aid of standardized questionnaires they will assess trauma related symptoms as well as prolonged grief disorder. under the supervision of clinical experts from the university of konstanz the local psychologists will carry out a randomized house to house survey (phase 1). as a second step, a controlled randomized clinical trial will be carried out. local psychologists will be trained in applying narrative exposure therapy and interpersonal psychotherapy. genocide survivors that will be identified with a ptsd diagnosis will randomly be assigned to either the treatment condition or a waiting list. the treatment group will receive 5 individual sessions of net in addition to 3 individual ipt sessions. subsequent 3-months and 6-months post-tests will serve to evaluate the efficacy of this treatment module in alleviating trauma related symptoms and symptoms of prolonged grief. we expect a significant symptom reduction in the experimental group and no significant symptom reduction in the waiting list. after the 6-months post-test, the trained psychologists will train other psychologists in applying this treatment module under the supervision of clinical experts from the university of konstanz. afterwards, they will apply therapy to the victims from the waiting list. a 12-months follow-up will serve to evaluate the long-term effect of the net/ipt combination.


Eligibility criteria:
inclusion criteria: * widows and orphans * confrontation of the rwandan genocide * clinical diagnosis of ptsd exclusion criteria: * mental retardation * psychotic symptoms * current drug or alcohol
efficiency of autologous amniotic fluid injection in the healing of cesarean section scar in high-risk population

Conditions: High Risk Pregnancy; Healing Surgical Wounds

Summary: the goal of this randomized controlled trial is to investigate the effect of injection of autologous amniotic fluid in the healing of the scar of cesarean section among high-risk population. investigator's aim is to know : quality of wound healing, rate of infection and time needed for complete healing. participants will be divided into two groups. all participants will undergo cesarean section. we will inject autologous amniotic fluid in the edges of the wound during skin closure in half of the participants. wound healing will be assessed at 1st, 2nd and 6th week postoperatively.

after surgery, participants will be observed along 6 weeks (at 1, 2 and 6 weeks intervals) and scars will be assessed regarding color, thickness, pliability and presence of exudate.

Eligibility criteria:
inclusion criteria: * age \> 30 years old. * anemic patients * maternal chronic disease e.g., diabetes and hypertension * bmi of \> 25 kg/m2. * underwent previous cs. exclusion criteria: * rupture of membrane. * no previous section. * anhydraminos. * congenital malformation of the fetus.

Keywords: amniotic fluid cesarean section scar (healing)
costovertebral mobilization on kyphotic posture and lung function in non-smoker

Conditions: Hyperkypohsis and Impaired Lung Function

Summary: aim of this study is to find the effects of costoverterbral mobilization on thoracic kyphosis and lung function in non-smoker. a randomized control trial that will include total 44 participants.the first group will receive costovertebral mobilization along with conventional therapy and 2nd group will receive conventional therapy.data collected will be analyzed through spss 25

kyphosis is the curvature of the thoracic spine, formed by the shape of the vertebrae and the intervertebral discs and-in standing position-paraspinal muscle strength. hyperkyphosis is usually associated with increased anteroposterior diameter of the thorax and a decrease in the distance between the xiphisternum and pubis and it is present when the kyphosis angle exceeds the normal ranges. this curve is concave anteriorly with a normal angle between 20˚ - 40˚. the lungs are the foundational organs of the respiratory system,whose most basic function is to facilitate gas exchange from the environment into the bloodstream.the decline in lung function could be associated with hyperkyphosis, as the curvature of the thoracic spine increases and the posture becomes more hunched, the mobility of the rib cage could be limited and restrict the thoracic and lung expansions during inspiratory maneuver. different treatment strategies such as surgery, splinting, exercises and manual therapies such as massage, muscle energy technique, and passive joint mobilization have been used to treat hyperkyphosis. costovertebral mobilization is a manual therapy technique, to improve the mobility and function of the joints between the ribs (costo) and the vertebrae (vertebral). this technique increases the range of motion of ribcage and spine, thus improve kyphosis posture and lung functions.

Eligibility criteria:
inclusion criteria: * non smoker * age: 20-40 years * normal body mass index 18.5 to 24.9 * both female and male gender * decrease forced expiratory volume-one second/ forced vital capacity ratio greater than or equal to 70% * increase thoracic kyphotic posture greater than or equal to 40˚ exclusion criteria: * any respiratory disease of the upper or lower respiratory tracts e.g. asthma, chronic bronchitis, copd, emphysema etc. which could altered the optimal lung functioning. * previous history of rib fractures, dislocations, sprains of costochondral, costosternal and interchondral joints. * smokers * scheuermann disease * primary and secondary neoplastic lesions of the spine and/or ribs * obvious advanced spinal deformity e.g. kyphoscoliosis * infection e.g. tuberculosis * primary and secondary neoplastic lesions of the soft tissue structures of the chest * inflammation e.g. acute rheumatoid arthritis or ankylosing spondylitis

Keywords: hyperkyphosis pulmonary functions costoverterbral mobilization fev1/fvc cobb angle