Kornimate/medical-research-clean huggingface dataset:
evaluating a microfinance intervention for high risk women in mongolia

Conditions: HIV Infection

Summary: the proposed study aims to test the feasibility and preliminary efficacy of a combined 4-session hiv sexual risk reduction (hivsrr) and microfinance intervention (including 34 training session and matched savings) to reduce unprotected sex and to increase proportion of income from sex work among women engaged in high risk sexual activity in ulaanbaatar, mongolia. feasibility and preliminary efficacy will be tested using a randomized clinical trial (rct) with 134 women sex workers meeting eligibility criteria. following eligibility screening, eligible women will complete informed consent, a baseline assessment, and be randomized to one of 2 study conditions: 1) the combination hiv sexual risk reduction plus microfinance (hivsrr+mf); or 2) a 4-session hivsrr alone control condition. the study design will permit us to: 1. examine and enhance the feasibility (i.e. recruitment, engagement, attendance, retention data collection) of a combination hiv sexual risk reduction and mf intervention with high risk women in ulaanbaatar, mongolia; 2. examine the preliminary outcomes of the interventions on decreasing unprotected acts of vaginal and anal intercourse; increasing the proportion of protected vaginal and/or anal acts using barrier protection and decreasing number of sexual partners with repeated measures at baseline, immediately post-intervention, and 3 and 6 month follow-up assessments. 3. use the results of the pilot study to inform the design of a future r01 application.


Eligibility criteria:
inclusion criteria: * she is at least 18 years of age; * she reports having engaged in vaginal or anal sexual intercourse in the past 90 days in exchange for money, alcohol or other goods; * she reports having engaged in unprotected vaginal or anal sexual intercourse in the past 90 days with a paying sexual partner; and * she reports being interested in learning about and developing her own small business. exclusion criteria: * assessed to have a severe cognitive or psychiatric impairment that would interfere with the ability to provide informed consent or complete study instruments

Keywords: hiv, prevention, microfinance, sex work, mongolia
the paleolithic diet and male factor infertility

Conditions: Male Infertility

Summary: prospective studies concerning diet and male fertility are lacking. observational studies suggest that a diet rich in fruits, vegetables and meats may be associated with higher sperm counts. the investigators wanted to see if a "paleolithic diet" consisting of meat, fish, fruits vegetables and nuts and lacking grains, legumes and dairy products can improve sperm counts.


Eligibility criteria:
inclusion criteria: * men with male infertility * willingness to make dietary change for three months * willingness to be blinded to sperm test results until the end of the experiment exclusion criteria: * high fever or abdominal or scrotal surgery during three months prior to intervention * change in diet, drinking or smoking habits in three months prior to intervention * regular consumption of more than two servings of alcohol a day * background ailment preventing dietary change
efficacy and safety of ckd-501 versus pioglitazone when added to metformin

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to prove effect of glucose reduction that ckd-501 and metformin combination treatment group is non inferiority compare to pioglitazone and metformin combination.

the aim of this phase 3 study was to evaluate the efficacy and safety of ckd-501 and metformin combination for 24 weeks in type 2 diabetes mellitus. furthermore, the extension study for additional 28weeks is designed to confirm long term safety of ckd-501 as an oral hypoglycemic agent.

Eligibility criteria:
inclusion criteria: * between 18 years and 80 years old(male or female) * type ⅱ diabetes mellitus * the patient who has been taking oral hypoglycemic agent since 2 months with hba1c 7 to 10% at screening test * bmi between 21kg/㎡ and 40kg/㎡ * c-peptide level is over 1.0 ng/ml * agreement with written informed consent exclusion criteria: * type i diabetes or secondary diabetes * continuous or non continuous treatment(over 7 days) insulin within 3 month prior to screening * treatment with thiazolidinediones within 60 days or patient who have experience such as hypersensitivity reaction, serious adverse event or no effect by treatment with glitazones * chronic(continuous over 7 days) oral or non oral corticosteroids treatment within 1 month prior to screening * past history: lactic acidosis or metformin contraindication * acute or chronic metabolic acidosis including diabetic ketoacidosis * history of proliferative diabetic retinopathy * severe infection, severe injury patients (pre and post operation) * oligotrophy,starvation, hyposthenia, pituitary insufficiency or capsular insufficiency * drug abuse or history of alcoholism * history of myocardial infarction, heart failure, cerebral infarction, hematencephalon or unstable angina within 6 months * fasting plasma glucose level is over 270 mg/dl * triglyceride level is 500 mg/dl and over * significant abnormal liver dysfunction: ast, alt level over or equal to 2.5 times, total bilirubin level over or equal 2 times as high as upper normal limit(unl) * significant abnormal renal dysfunction * anemia * abnormality of thyroid function(out of significant normal tsh range ) * hepatitis b or c test is positive * pregnant women or nursing mothers * has a contraindication to treatment * fertile women who not practice contraception with appropriate methods * participated in other trial within 4 weeks * participating in other trial at present * in investigator's judgment
design and evaluation of an individualized biodrug tapering strategy based on biodrug dosage: the monitora study

Conditions: Arthritis, Rheumatoid

Summary: rheumatoid arthritis (ra) is the most common inflammatory joint disorder. since twenty year and the use of synthetic disease-modifying anti-rheumatic drugs (csdmards) and biological (b)dmard, remission can be reached. when remission is obtained, the physician has no recommendations for managing a step-down, and future guidelines will be useful to assist the clinician. recent data suggest that tapering is feasible, but with high risk of flares. flares are less frequent when bdmard blood concentration is high. but, the optimal adalimumab concentration to keep before a step of tapering no targeting personal is unknown.


Eligibility criteria:
inclusion criteria: * patient over 18 years of age * patients with a diagnosis of ra according to acr/eular 2010 criteria * remission according to das28\<=2.6 for at least 6 months * patient treated with ada for at least 6 months. the patient is treated according to one of the following two strategies: * ada 40 mg every two weeks (= every 14 days) according to the standard regimen * or ada 40 mg every 3 weeks (= every 21 days) * a negative highly sensitive pregnancy test for women of childbearing potential\* * affiliated person or beneficiary of a social security scheme * informed consent signed by the patient after information exclusion criteria: * incapacity or refusal to understand and / or sign informed consent to participate in the study. * existing pregnancy, lactation, or intended pregnancy within the next 15 months * fibromyalgia associated to ra * any dose of prednisone for ra treatment 6 months before inclusion * patient deprived of liberty or patient under guardianship or curator ship.

Keywords: arthritis, rheumatoid adalimumab remission management step wedge trial
the liver care trial

Conditions: Alcoholic Liver Disease; Alcohol Use Disorder; Alcohol Abuse; Alcoholism; Fibrosis, Liver; Alcohol-Related Disorders

Summary: the goal of this clinical trial is to evaluate the efficacy of screening for liver disease with liver stiffness measurement on abstinence or light consumption after 6 months in individuals who are receiving treatment for alcohol use disorder and without a history of liver disease. the investigators will conduct a randomized controlled trial with concealed allocation comparing a) an invitation to a liver stiffness measurement, blood sampling and leaflet on alcohol-related disease (intervention) with b) an invitation to blood sampling (control). the primary outcome is 'abstinence or light consumption' (≤ 10 units/week) throughout the last months, and assessed 6 months after randomization.


Eligibility criteria:
inclusion criteria: * attending outpatient treatment for alcohol use disorder (international classification of disease version 10: f102: alcohol dependence or f101: harmful alcohol use) at novavi køge or novavi roskilde * informed written consent exclusion criteria: * not speaking danish or english * severe liver disease (known by the participant)

Keywords: screening fibroscan liver stiffness measurement abstinence
reciprocal inhibition versus reciprocal facilitation in spinal cord injury patients

Conditions: Spinal Cord Injuries

Summary: reciprocal inhibition is a medulla spinalis control mechanism that facilitates motor activities in healthy people. as the agonist muscle contracts, the antagonist muscle is inhibited so that the agonist action can take place properly. in the literature, there are studies showing that in patients with upper motor neuron lesions, this reverses, and reciprocal facilitation occurs instead of inhibition. however, there is no clear situation in this regard, there is a need for more methodologically sound studies. our aim in this study is to investigate the presence of reciprocal facilitation in patients with spinal cord lesions (scl).

reciprocal inhibition is a spinal segmental control mechanism that facilitates motor activities in healthy people and is also used in treating spasticity. considering the current literature, there are some studies claiming that this is reversed in patients with upper motor neuron lesions and that there is reciprocal facilitation instead of inhibition. however, the proposed evidence is not convincing. our aim in this study was to investigate the presence of reciprocal facilitation in detail in patients with upper motor neuron lesions. this study was conducted in five patients with spinal cord lesions and five healthy individuals. both the tibialis anterior and soleus muscles of the cases were recorded using surface and multi-motor unit electromyography (emg) electrodes. to elicit an h reflex in the soleus muscle, an electric current was delivered through the popliteal fossa using the monopolar technique. the achilles tendon was tapped with the reflex hammer to elicit a t reflex. since the h-reflex and t-reflex responses were detected in the tibialis anterior muscle surface and multi-motor unit emg recordings, the findings were evaluated as direct stimulation, cross-talk, and reciprocal facilitation. methodologically, this research aimed to be a guiding study for future studies.

Eligibility criteria:
inclusion criteria: * patients with spinal cord injury between the ages of 18-60 * a minimum of 6 months of scl history * soleus spasticity exclusion criteria: * patients with premorbid neuromuscular disease * history of autonomic dysreflexia * patients in the spinal shock period * those who have a coronavirus disease clinic * less than 2 hours sitting tolerance

Keywords: spinal cord motor neuron spasticity
mindfulness and interpersonal effectiveness skills in borderline personality disorder

Conditions: Borderline Personality Disorder

Summary: the purpose of the study was to determine whether mindfulness training could be more effective than another active intervention in reducing borderline personality disorder (bpd) symptoms. the main hypothesis was that patients allocated to the mindfulness group would show a greater improvement on global bpd symptomatology. as a second objective, we explored some of the possible underlying mechanisms of both active treatments. for that purpose, changes in decentering, mindfulness facets and cognitive processing of social interactions were also evaluated.

the present study aimed at evaluating the efficacy of mindfulness skills (m) versus interpersonal effectiveness skills (ie) on borderline symptoms. for that purpose, a randomized, active-controlled clinical trial was designed. 64 participants with borderline personality disorder (bpd) diagnosis were allocated to mindfulness (n=32) or interpersonal effectiveness skills (n=32). both interventions were delivered over a 10-week period. the borderline symptom list (bsl-23) was elected as the primary outcome measure. mindfulness related capacities, decentering and cognitive processing of social interactions were also evaluated with the five facet mindfulness questionnaire (ffmq), the experiences questionnaire (eq) and the multidimensional scale of social expression (emes-c), respectively. assessments were conducted pre and post interventions.

Eligibility criteria:
inclusion criteria: * ages between 18 and 45 years * bpd criteria according to two diagnostic interviews (scid-ii and dib-r) exclusion criteria: * lifetime diagnosis of schizophrenia, drug-induced psychosis, organic brain syndrome, bipolar disorder or mental retardation * participating in any sort of psychotherapy during the study or having participated in dialectical behavioral therapy groups in the past

Keywords: borderline personality disorder mindfulness
mr imaging study of tbi in children

Conditions: TBI (Traumatic Brain Injury)

Summary: this project will combine the data collected from structural and functional mri scans and neuropsychology performance post-tbi in children. patients will be followed for a year, in order to examine the brain and cognitive recovery post head injury.

traumatic brain injury in childhood has an cumulative effect that leads to impairments in cognitive functions such as deficits in memory, executive functions and attention. the cognitive impairment is the main cause of disabilities in the injured population, and has a different effect depending on the type and severity of the injury. imaging after brain trauma serves as a useful diagnostic tool in identifying the head trauma's results. therefore, in recent years, using imaging methods, studies have tried to find measures which will be able to predict the functional outcome after brain injury in children, and assist in developing a personalized rehabilitation program. the combination of advanced imaging techniques with neuropsychological assessment within the early stage of the injury and during a year of followup, will allow us to establish the relationship between those measures and the functional recovery result of the children. this multi-analysis will enable us to have a deeper understanding of the neuroplasticity process and the functional recovery after brain injury in the developing young brain.

Eligibility criteria:
inclusion criteria: 1. patients 9-18 years old, which are/were hospitalized in the pediatric rehabilitation department, sheba medical center 2. glasgow coma scale score of 3-15. 3. hebrew as mother-tongue exclusion criteria: 1. history of neurological disorders, mental retardation or a previous head injury. 2. current diagnosis or history of psychiatric disorders. 3. cardiovascular instability. 4. metabolic instability (water, electrolytes, sugar). 5. fever or evidence of microbiological pollutant. 6. uncontrolled seizures. 7 . hydrocephalus. 8. deafness or blindness. 9. renal failure.

Keywords: traumatic brain injury children pediatric mri fmri cognition dti longitudinal connectivity dai neuropsychology rehabilitation
treatment of chinese participants with b-cell malignancies with bgb-16673, a bruton tyrosine kinase-targeted protein-degrader

Conditions: B-cell Malignancy; Non-Hodgkin Lymphoma; Mantle Cell Lymphoma; Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma; Waldenström Macroglobulinemia; Marginal Zone Lymphoma; Follicular Lymphoma; DLBCL Unclassifiable; Richter's Transformation

Summary: this study aims to explore the recommended phase 2 dose and evaluate the safety, tolerability and preliminary antitumor activity of bgb-16673 monotherapy at the recommended phase 2 dose for the selected b-cell malignancy expansion cohorts


Eligibility criteria:
key inclusion criteria 1. provision of signed and dated written informed consent prior to any study 2. eastern cooperative oncology group (ecog) performance status of 0 to 2 3. adequate organ function of coagulation function, liver function, renal function and pancreatic function and measure disease per disease-specific response criteria 4. phase 1: confirmed diagnosis of r/r marginal zone lymphoma (mzl), follicular lymphoma (grade 1-3a), waldenström macroglobulinemia (wm), non-germinal center b-cell (non-gcb) diffuse large b-cell lymphoma (dlbcl), richter's transformation to dlbcl, mcl, or cll/sll 5. phase 2: confirmed diagnosis of mcl, or cll/sll 6. highly effective method of birth control during study treatment period, and for at least 90 days after the last dose of the study drug key exclusion criteria 1. prior malignancy (other than the disease under study) within the past 2 years, except for curatively treated basal or squamous skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized gleason score ≤ 6 prostate cancer 2. require ongoing systemic treatment for any other malignancy or systemic corticosteroid treatment 3. receiving treatment with a strong cyp3a inhibitor or inducer ≤ 14 days before the first dose of bgb-16673, or proton-pump inhibitors ≤ 5 days before the first dose of bgb-16673. 4. current or history of central nervous involvement 5. prior autologous stem cell transplant unless ≥ 3 months after transplant, prior chimeric cell therapy unless ≥ 6 months after cell infusion, prior allogeneic stem cell transplant ≤ 6 months before the first dose of the study drug note: other protocol defined inclusion/exclusion criteria may apply

Keywords: b-cell malignancy mzl fl dlbcl richter's transformation cdac btk degrader bgb-16673
drug eluting stent zilver ptx vs bare metal stent zilver flex

Conditions: Vascular Diseases

Summary: randomized study comparing the results between drug-eluting stents and standard bare metal stents, when treating femoropopliteal lesions in patients with critical limb ischemia.


Eligibility criteria:
inclusion criteria: critical limb ischemia rc 4-6 lesions in superficial femoral artery and popliteal artery (p1 -p2) target vessel 4-8mm at least i 1 vessel runoff to the foot age \>18 years exclusion criteria: pregnancy patient disapproval age \<18 years
manual therapy in treating fibrosis-related late effect dysphagia in head and neck cancer survivors

Conditions: Cancer Survivor; Dysphagia; Fibrosis; Head and Neck Carcinoma

Summary: this trial studies how well manual therapy works in treating fibrosis-related late effect dysphagia in head and neck cancer survivors. manual therapy is the use of massage and stretching exercises to increase blood flow and muscle movement in the neck, throat, jaw, and mouth, which may help to improve swallowing ability and range of motion in participants who have had treatment for head and neck cancer.

primary objectives: i. to determine the feasibility and safety of manual therapy for treatment of fibrosis-related dysphagia in head and neck cancer survivors. secondary objectives: i.to estimate effect size, dose-response (number of treatment sessions to normalized cervical range of motion), and durability of manual therapy for improving cervical range of motion in head and neck cancer survivors with fibrosis-related late dysphagia. ii. to examine functional outcomes after manual therapy in head and neck cancer survivors with fibrosis-related late effects and their association with change in dysphagia grade, cervical extension, and other cofactors. outline: participants receive 10 manual therapy sessions performed by a speech pathologist during weeks 1-6. after completion of 6 weeks of therapy, participants perform manual therapy at home daily for 6 weeks.

Eligibility criteria:
inclusion criteria: * late dynamic imaging grade of swallowing toxicity (digest) grade \>= 2 dysphagia on modified barium swallow (mbs) \>= 2 years after curative-intent radiotherapy for head and neck cancer * grade \>= 2 common terminology criteria for adverse events (ctcae) fibrosis * willing and able to return for 10 sessions over 6 weeks of therapy exclusion criteria: * active recurrent or second primary head and neck, central nervous system, or thoracic cancer at time of enrollment * active osteoradionecrosis or other non-healing wounds (e.g., fistula, ulcer, soft tissue necrosis) in manual therapy (mt) regions of interest at time of enrollment * history of subtotal or total glossectomy or total laryngectomy * functionally limiting cardiac, pulmonary, or neuromuscular disease * current tracheostomy
cgm use in islet transplant recipients

Conditions: Islet Transplantation; Type1 Diabetes Mellitus

Summary: a study assessing glucose variability in subjects with type 1 diabetes who have had islet transplant.

subjects who have an islet transplantation may have several outcomes including time when insulin is not required followed in some cases by additional insulin for glucose control as patients get further away from transplantation. it is unclear what role automated insulin delivery systems will have in addressing glucose variability in this group of patients who may have some amount of islet function. as a precursor to understanding ways in which automated insulin delivery systems may need to be adapted, we propose to gather data on glucose variability and insulin regimens in individuals who have undergone an islet transplantation.

Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus * recipient of islet transplantation * age 18 or older * females, not currently know to be pregnant * demonstration of proper mental status and cognition for the study * understanding and willingness to follow the protocol and informed consent form * access to the internet and willingness to upload data during the study, including use of personal laptop exclusion criteria: * pregnancy and intent to become pregnant during trial * use of acetaminophen (such as tylenol) * current enrollment in another intervention clinical trial that affects glucose variability

Keywords: type 1 diabetes mellitus islet transplantation continuous glucose monitor (cgm)
human factors and home use study of the vigilant diabetes management application

Conditions: Diabetes Mellitus

Summary: a human factors and home use study to assess whether subjects with diabetes and their caregivers can understand feedback received from the vigilant diabetes management application about their blood glucose patterns and whether the decisions made in response to device feedback are made in accordance with the intended use.


Eligibility criteria:
inclusion criteria: * persons with diabetes mellitus testing blood glucose 3 or more times per day * clinicians who see diabetes patients exclusion criteria: * admission for diabetic ketoacidosis in the 6 months prior to enrollment * a recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol * patients who are not willing to share their glucose meter data, or do not perform the tasks asked of them and follow instructions for the study will be excluded * pregnancy