Kornimate/medical-research-clean huggingface dataset:
an acceptance based prep intervention to engage young black msm in the south

Conditions: HIV Prevention

Summary: investigators will use a generalized framework for the adaptation of ebis to inform the development of a brief acceptance and commitment therapy (act)-based culturally appropriate pre-exposure prophylaxis (prep) intervention tailored to young black men who have sex with men (ybmsm), named actprep.

investigators will use a generalized framework for the adaptation of ebis to inform the development of a brief acceptance and commitment therapy (act)-based culturally appropriate pre-exposure prophylaxis (prep) intervention tailored to young black men who have sex with men (ybmsm), named actprep. specific aim 1) gather data from ybmsm (n = 20) and clinic staff (n = 10) through in-depth interviews to assess quantitative measures, intervention design, and experiences most relevant to prep engagement. specific aim 2) develop actprep utilizing aim 1 data, working iteratively with experts, and an intervention "run through" with a sample of participants. clinical trial is aim 3 only specific aim 3) evaluate actprep. enroll 66 participants. primary outcomes will be feasibility (measured by percentage eligible, consented, randomized, and retained) and acceptability (measured by the client satisfaction questionnaire). secondary outcomes will compare actprep vs. enhanced standard of care condition (esoc) on behavior outcomes (uptake, adherence, and prep persistence) and possible mediators over the course of 24 weeks. barriers and facilitators to implementing actprep will be assessed with post-rct qualitative interviews using the i-parihs framework.

Eligibility criteria:
inclusion criteria: * english speaking * between 18-34 years old * male sex assigned at birth * identify as african american/black * not enrolled in another prep related study * able to give consent * not taken prep in past 3 months * report having sex with a man in the past 3 months * prep-eligible according to cdc guidelines exclusion criteria: * participating in another prep study * unable to provide consent

Keywords: act prep
platelet rich plasma (prp) injections for knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: it was conducted a prospective study with a series of 153 patients treated with prp injections in patient affected by knee osteoarthritis. one independent observer performed clinical and functional evaluations at t0 (recruitment), t1 (one month after the injection), t2 (three months after the last injection) and t3 (six months after the last injection). the western ontario and mcmaster universities osteoarthritis index (womac), the knee score society (kss) score and the visual analogue scale (vas) were evaluated and recorded for each patient at each follow up.


Eligibility criteria:
inclusion criteria: * age between 40 and 81; * body mass index (bmi) between 21.5 and 29.3; * chronic history (for at least 4 months) of knee joint pain; * radiographically documented knee osteoarthritis of grades 1 to 3 (kellgren-lawrence (k-l) radiographic classification scale) exclusion criteria: * radiographically severe documented knee osteoarthritis of grade 4 (k-l radiographic classification scale); * previous femur and tibia fractures; * knee previous surgical treatment (e.g., arthroscopy); * hyaluronic acid infiltration within the previous six months; * hemoglobin levels \<10 g/dl; * history of oncohematological disease, infections, or immunodepression

Keywords: knee osteoarthritis (koa); platelet-rich plasma (prp);
effects of cycling and virtual reality on thinking speed in persons with ms (pace-ms)

Conditions: Multiple Sclerosis

Summary: to compare the effects of cycling exercise with different types of virtual reality on processing/thinking speed in persons with multiple sclerosis (ms).

the purpose of this research study is to learn how different types of cycling exercise can improve short-term processing speed, or speed of thinking, in persons with ms. in this study, we will compare the effects of cycling alone to cycling with two different types of virtual reality. participants will complete all three cycling conditions, one per week. we are studying these types of cycling because there are currently no effective treatment options to improve processing speed in persons with ms and combining exercise with virtual reality is a promising technique.

Eligibility criteria:
inclusion criteria: * speak english as their primary language * confirmed ms diagnosis by a neurologist * be relapse and steroid-free for at least 30 days * mild-to-moderate self-report mobility disability exclusion criteria: * history of neurological disorders besides ms or history of uncontrolled psychiatric disorders (ex: major depression) * have contraindications to exercise, based on the physical activity readiness questionnaire (par-q) * currently use medications that may impact cognition (ex: steroids, benzodiazepines) * currently pregnant * severe cognitive impairment as measured by the modified telephone interview of cognitive status (tics-m) * no indication of age-related mild cognitive impairment or dementia, based on the moca-blind (i.e., moca-blind ≥19). * high likelihood of motion sickness * regular cyclist, defined as cycling for at least 150 minutes/week

Keywords: multiple sclerosis leg cycling virtual reality mobility disability processing speed
efficacy and safety of skcpt in patients with knee osteoarthritis: phase iii clinical trial

Conditions: Osteoarthritis, Knee

Summary: multi-center, randomized, double blinded, active-controlled phase iii clinical trial to assess the efficacy and safety of skcpt in patients with knee osteoarthritis


Eligibility criteria:
inclusion criteria: * adult males and females aged 20 to 75 years * kellgren-lawrence (kl) grade 1 to 3 * individuals who voluntarily decide to participate in the study and provide written informed consent form * individuals who can understand and follow instructions and can participate in the study during the entire study period exclusion criteria: * individuals who have clear secondary osteoarthritis caused by inflammatory, infectious, metabolic arthritis, or other conditions such as rheumatoid arthritis, rather than primary knee osteoarthritis as determined by the investigator * individuals with other factors that could potentially affect the assessment of this clinical study due to pain caused by osteoarthritis or other conditions in the hip joint * individuals who have undergone knee joint arthroplasty * individuals who have undergone open knee surgery (ligament reconstruction, osteotomy) within 3 years prior to the screening visit
a phase 1 trial to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of shr-3167 single injection in healthy subjects and patients with type 2 diabetes

Conditions: T2DM

Summary: this is a randomized, double-blind, placebo-controlled, single-dose escalation trial was designed. there are 6 dose groups and 1 optional dose group: 0.5 mg, 2 mg, 8 mg, 25mg, 50 mg, 100 mg and 150 mg (optional). eight healthy adult subjects or t2dm patients in each dose group (except for 0.5 mg dose group, only 4 subjects will be enrolled) are randomly assigned to subcutaneously injection of shr-3167 or placebo according to 3:1 ratio.


Eligibility criteria:
inclusion criteria: 1. male or female, 18 years ≤ age ≤ 55 years (healthy subjects) or 18 years ≤ age ≤ 65 years (t2dm patients) 2. 18.5 kg/m2≤ body mass index (bmi) \<26.0 kg/m2 (healthy subjects) or 18.5 kg/m2≤ bmi \<35.0kg/m2 (t2dm patients), and male weight ≥50kg and female weight ≥45kg 3. t2dm patients: 7.0% ≤ hba1c ≤9.5%, 7.5mmol/l≤ fasting blood glucose ≤15mmol/l 4. healthy subjects: 3.9 mmol/l\< fasting blood glucose \< 6.1mmol/l and hba1c ≤6.0% at screening 5. signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the study. exclusion criteria: 1. history of significant multiple and/or severe drug allergies or with a known allergy to the trial product or any medicine chemically related to the trial product 2. presence of cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, hematological, neurological, or psychiatric diseases or disorders. 3. history of severe cardiovascular and cerebrovascular disease, including heart failure (nyha class ii to iv), myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack, severe arrhythmia, or coronary artery bypass grafting or percutaneous coronary intervention, 6 months before screening to before randomization; 4. t2dm patients: a) severe hypoglycemia, frequent hypoglycemia, ketoacidosis, or hypertonic coma from 6 months before screening to before randomization; b) known proliferative diabetic retinopathy ordiabetic macular edema, or non-proliferative diabetic retinopathy requiring treatment during the trial; 5. those who had a severe infection, severe trauma, or had undergone surgery in the 12 weeks prior to screening, or planned to undergo surgery during the trial 6. participants who participated in a clinical trial of any other drug or medical device from 3 months prior to screening to before randomization or planned to participate during the study period
peripheral nerve blocks for above-the-knee amputations

Conditions: Peripheral Vascular Diseases; Hyperglycaemia (Diabetic); Hypertension; Coronary Artery Disease; Pulmonary Disease, Chronic Obstructive

Summary: surgery performed with nerve blocks and sedation may be safer and provide better pain control compared to general anesthesia and opioid therapy in high-risk patient populations such as elderly and troubled with peripheral vascular disease, diabetes, hypertension, coronary artery disease, and chronic obstructive pulmonary disease (copd).

avoidance of general anesthesia in certain high-risk patient populations may have additional benefits beyond improved postoperative pain scores and analgesic consumption. the primary objective of this research will be to evaluate the ability of the femoral, sciatic, lateral femoral cutaneous nerve (lfcn), and obturator blocks to provide surgical anesthesia.

Eligibility criteria:
inclusion criteria: * patients undergoing above-the-knee amputation or knee disarticulation * ability to understand and provide informed consent exclusion criteria: * patient refusal or inability to provide informed consent * true allergy, not sensitivity, to any of the following substances: * - local anesthetics * - propofol or other sedative agents * - general anesthetic agents * pregnancy * severe hepatic impairment * evidence of infection at or near the proposed needle insertion site * any sensorimotor deficit, whether acute or chronic, as determined by the pi * chronic use of opioid medication * bmi ≥ 35
weight loss maintenance in primary care

Conditions: Obesity; Overweight

Summary: after a three month weight loss phase involving the use of meal replacements, participants are randomized into different weight loss maintenance conditions. aim 1: to test the hypothesis that the meal replacement (mr) and reduced energy density eating (rede) interventions, when added separately to the learn program, will produce superior weight loss maintenance compared to a learn-only intervention. aim 2: to test the hypothesis that the weight loss maintenance condition that combines mrs and rede will produce better maintenance of weight losses than either individual component and than the learn-only condition. aim 3: to test the hypothesis that the two conditions receiving the rede intervention will experience longer-lasting improvements in the energy density and nutritional composition of the diet compared to the two non-rede conditions.


Eligibility criteria:
inclusion criteria: * bmi of 30, or bmi of 27 with weight-related comorbidities * access to a telephone and voice mail/answering machine * must be seeing a primary care physician working with us on this study (in the greater philadelphia area) exclusion criteria: * previously/currently diagnosed with an eating disorder * current bi-polar, depression, substance abuse, or dependence disorder * living with someone already enrolled * enrolled in another weight loss program * current disorder/medications affecting body weight or energy expenditure (e.g. thyroid disease) * myocardial infraction within the past three months * unstable angina * nephrotic syndrome/malabsorptive disease * gout attack within the past year * lactating/pregnant (or planning within next two years) * current/recent history of cancer, neurological disease, high creatinine levels, active hepatic disease

Keywords: eating dieting meal replacements energy density weight loss maintenance
investigation of dysregulated signaling in mpd via multiparameter phospho-specific flow cytometry

Conditions: Myeloproliferative Disorders; Myeloproliferative Disorders (MPD)

Summary: the objective of this study is to better understand the underlying pathogenetic mechanisms of myeloproliferative disorders (mpds). we will collect peripheral blood samples from mpd patients and utilize multiparameter phospho-specific flow cytometry to investigate dysregulated signaling in blood cells from these patients. this will provide deeper insights into the pathogenesis of mpds and may lead to the identification of novel targets for therapeutic intervention.


Eligibility criteria:
inclusion criteria:any patient who carries a diagnosis of a myeloproliferative disorder (mpd). exclusion criteria:any patient who is not willing to give consent.
prolotherapy versus steroids for thumb carpo-metacarpal joint arthritis

Conditions: Thumb Carpometacarpal Joint Osteoarthritis

Summary: arthritis of the base of the thumb is a common debilitating problem. it is believed that laxity (loosening) of the joint leads to worsening arthritis in this joint. this can be treated by securing the joint surgically or symptoms can be treated with hand therapy and/or injection of corticosteroids. recently prolotherapy (sugar water) has been shown to decrease looseness of joints and also be helpful for hand and knee arthritis. we hypothesize that prolotherapy injections for thumb arthritis will be equally or more beneficial to the patients than steroids.

dextrose prolotherapy has been shown to decrease anterior cruciate ligament (acl) laxity and decrease knee joint pain. similar to acl laxity leading to knee osteoarthritis, laxity of the "beak" ligament can lead to worsening thumb cmc osteoarthritis. we hypothesize that dextrose intra-articular prolotherapy will have similar results in treating the pain and instability related to symptomatic thumb cmc osteoarthritis. this will be a prospective randomized double blind comparison study comparing celestone to dextrose intra-articular injections as adjuncts to hand therapy for the treatment of symptomatic thumb cmc osteoarthritis. twenty patients will be randomized to each treatment arm to provide enough power to show a 20% change in visual analogue scale (vas) for pain to be significant. we will utilize the ultrasound guided injection protocol described by the co-investigators for both treatment arms to ensure proper placement of the respective solutions. we will measure various grip strengths, and vas pain scales prior to the first injection, prior to the second injection at 6 weeks and at the final visit at 6 months. a telephone follow-up with pain scale will be administered at 3 months. a quick disabilities of the arm, shoulder and hand (dash) questionnaire measuring upper extremity functional impairment will be obtained at initial and final visits.

Eligibility criteria:
inclusion criteria: * age \>45 * ability to make follow-up visits over the 6 month protocol * ability to give informed consent * eaton grade 2-3 thumb carpo-metacarpal joint osteoarthritis with pain over 3/10 on visual analogue scale with symptoms present greater then 6 months. exclusion criteria: * recent trauma to the hand or wrist or fractures eeen on radiographs * eaton grade 1, or 4 joints affected * metabolic bone disease * recent systemic or localized infection (within last 2 weeks) * history of rheumatologic disease * allergies to injected solutions * thumb carpo-metacarpal joint injections in the prior 6 months.

Keywords: thumb carpo metacarpal joint osteoarthritis prolotherapy intra articular steroid hand therapy
soft tissue esthetic with autogenous dentin chips and immediate implantation versus conventional immediate implantation with xenograft in thin buccal bone

Conditions: Crestal Bone Loss

Summary: after tooth extraction, host bone resorption and atrophy of alveolar ridge may be observed. bone resorption occurs specially in incisors and premolar area of jaw in region of thin buccal bone that may lead to change in contour. total clinical bone loss height approximately 2-5 mm at first 6 months may be observed in vertical dimension , after 12 months alveolar ridge may lose up to 50 % of its width.

recently augmentation with bone grafting became one of the most common techniques surgically ; progressive bone resorption may be prevented by using augmentation procedures with use of graft materials. the gold standard in regenerative procedures is autogenous bone graft because of osteoinduction , osteoconduction and osteointergration properties required in regeneration. in autogenous bone graft there is need for a second surgical site , donor site morbidity and limited availability will lead to challenge for alternative bio-materials. extracted healthy non functional teeth from human are considered to be a dental waste all over the world. high proportion of extracted sockets are left untreated for physiological healing. inadequate or failure of bone healing in sockets has been seen due to absence of bone graft material. stem cells, matrix , trace metal ions and growth factors are rich in human tooth. bone and dentin tissue structure are different but ratio of components is similar (mineral 70% , collagen 20% and body fluid 10% by weight). dentin after demineralization is mainly composed of type 1 collagen 95% and non collagenous proteins as growth factors.

Eligibility criteria:
inclusion criteria: * patient related : * patient who only need to restore this single tooth. * good oral hygiene * systemically healthy (free from any systemic diseases) site related : * hopeless tooth (nonrestorable, badly broken, endodontically treated) indicated for extraction and immediate implant placement * esthetic area with thin buccal bone * having periapical bone more than 3mm for primary stability exclusion criteria: * patient related : * smokers * pregnant woman site related * teeth that have to be extracted due to advanced periodontal bone loss * trauma in aesthetic area * periapical infection.

Keywords: dentin immediate implant buccal bone resorption crestal bone loss
metacognitive and insight therapy for persons with schizophrenia (rct merit)

Conditions: Diagnosis of Schizophrenia Spectrum Disorders

Summary: people with schizophrenia spectrum disorders are faced with significant metacognitive impairments that include difficulties in their ability to form complex representations of the self and others. these impairments are associated with increased symptoms, impaired subjective self-experiences, and lower social functioning. as a result, interventions that enhance metacognitive capacity have been recently developed and explored. one of these interventions is metacognitive reflection and insight therapy (merit; lysaker et al., 2014). merit is an integrative model of psychotherapy that seeks to promote holistic metacognitive capacity and consequently increase a positive sense of agency and sense of meaning in life among clients with schizophrenia. several case studies (including in bar-ilan's community clinic), as well as a recent pilot study, showed increased metacognitive abilities and a decrease in symptoms following merit. the current study will explore both the effectiveness and the change mechanisms that underlie merit interventon among clients diagnosed with schizophrenia spectrum disorders, via both pre- and post-measures of the intervention's outcome and session-by-session estimations of the therapeutic process.


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia spectrum disorders * ability to provide informed consent * ability to read and write in hebrew exclusion criteria: * no co-morbid nuerological condition * no hospitalization in the last 6 months

Keywords: schizophrenia psychotherapy metacognitive abilities session by session assessment outcome
systems of underprivileged preschoolers in their home and preschool environment: family intervention trial

Conditions: Child Obesity

Summary: this study will evaluate the effectiveness of superfit, an integrative lifestyle intervention for preschool children. it will consist of both an preschool component and a family component and is aimed at increasing healthy nutrition and physical activity. half of the participating preschools will implement superfit, while the other half of the preschools will continue as usual.


Eligibility criteria:
inclusion criteria: * children attending the participating preschools * at least one parent has to be able to understand the dutch language * both caregivers (if applicable) of the child give informed consent exclusion criteria: * there are no exclusion criteria for this study