Kornimate/medical-research-clean huggingface dataset:
high dose rifapentine pharmacokinetics, tolerability and safety dosage rifapentine for treatment of tuberculosis

Conditions: Smear Positive, Pan-sensitive, Pulmonary Tuberculosis

Summary: the primary objective of this study is to characterize rifapentine drug levels in patients with tb in relationship to its effectiveness in treating tb and any adverse effects experienced by participants.

this is a one-period, non-blinded, multi-center pharmacokinetic substudy of rifapentine and rifampin in patients with tuberculosis enrolled in tuberculosis trials consortium (tbtc) study 29. this pk substudy will use a convenience sample, i.e. be restricted to tbtc sites having logistical capacity for intensive pharmacokinetic sampling. these sites will have non-random selection of patients. in addition to the intensive sampling of 60 patients in this pk study, all patients receiving rifapentine in study 29 will be eligible for sparse pk sampling as part of the parent treatment protocol.

Eligibility criteria:
inclusion criteria: * any patient enrolled in tbtc study 29. * provision of informed consent for the study. * willingness to be sampled in an out-patient clinic or be admitted to a general clinical research center (gcrc) or hospital on one occasion exclusion criteria: • severe anemia as defined by a hematocrit less than 25% (most recent value, measured within 30 days of the pk study).

Keywords: rifapentine, pharmacokinetics, pharmacodynamics, tuberculosis
therapeutic education intervention in breast cancer: peps hormonotherapy

Conditions: Breast Cancer

Summary: the purpose of this study is to evaluate the feasibility and the effectiveness of a patient education program on patients' adherence to adjuvant hormone therapy (anti-estrogen or aromatase inhibitors) for breast cancer, in collaboration with teams of sociologists, patient education and medical oncologists.


Eligibility criteria:
inclusion criteria: * aged over 18 * history of breast cancer * medical prescription for an adjuvant hormonal treatment (anti-estrogens and / or aromatase inhibitors) as monotherapy or in combination with other treatments * affiliated to a social security scheme exclusion criteria: * refusal to participate, patient protected by guardianship. * patient unable to understand the study or unable to follow the education sessions. * patient with documented cognitive or psychiatric history. * geographical remotness (more than 100 kms).

Keywords: therapeutic patient education patient adherence empowerment breast cancer oral adjuvant endocrine therapy side effects
reducing socioeconomic disparities in health at pediatric visits

Conditions: Asthma; Obesity; Health Care Utilization; Health Care Disparities; Basic Unmet Social Needs; Blood Pressure; Child Maltreatment; Child Development

Summary: this research project is aimed to assess the effectiveness and impact of a pediatric-based intervention aimed at reducing low-income families' unmet material needs (food, housing, employment, childcare, household heat, education and learning the english language ) on child health.

this project builds upon the pi's prior studies including a recently completed cluster randomized controlled trial (rct) at community health centers in boston, which demonstrated a positive impact on provider referrals, discussion, and family receipt of resources. this study will specifically test the effectiveness of a further strengthened intervention "we care 2.0" on provider referrals and family receipt of resources, along with its impact on child health, health care utilization, and developmental outcomes. finally, we will gather information from stakeholders at the health centers in order to learn more about the facilitators and barriers to implementation of the model. the study will take place at six community health centers in the greater boston area. the centers will be randomized to either an intervention or control site. data will be collected on referrals, receipt of resources, and child outcomes from the child's electronic medical record (emr) from birth to age 3. focus groups will be used to gather implementation data from intervention health center personnel. the we care 2.0 intervention consists of: 1) we care surveys which parents complete prior to their child's well-child visits; 2) information technology (it) generated provider referrals which providers use to provide families with resource information sheets; 3) peer patient navigators who assist families in connecting to available resources and updating providers; and 4) training sessions for providers and office staff. families attending the control health centers will receive standard of care. of note, since the health centers share a common emr and for ethical reasons, control sites will have access to the it generated referral mechanism.

Eligibility criteria:
inclusion criteria: * child is on medicaid insurance * is attending routine newborn visit exclusion criteria: * premature (less than or equal to 32 weeks ga) * has a chronic disease * has neonatal abstinence syndrome * has a foster parent

Keywords: community resource well-child care visit low-income
effect of local cannabidiol on clinical and inflammatory outcomes in periodontal maintenance patients.

Conditions: Periodontitis, Adult; Inflammation Gum

Summary: this study will determine if cannabidiol (cbd) has any effect on local inflammation in periodontal maintenance patients. many successful therapies exist for the active, untreated periodontal patient. unfortunately, periodontology has not yet discovered a therapy that will predictably treat local inflammation in patients who are at risk for further pocketing, bleeding on probing, bone loss and ultimately, tooth loss. although cbd has been patented in various forms since the 1940s, its acceptance and availability to patients has only recently expanded. marketing of cbd to periodontal patients as a means to control inflammation is commonplace online and in cbd-specific shops. in determining if cbd is a successful supplement to conventional periodontal inflammation control therapies, millions of patients could benefit from this treatment.

the purpose of this study is to determine if cbd has any effect on local inflammation in periodontal maintenance patients. this research is significant and innovative as it will act as a pivotal study to determine if cbd is worthy of further study in the area of periodontal disease and it will be a human clinical trial focusing on a specific aspect of periodontal disease, the maintenance patient. many successful therapies exist for the active, untreated periodontal patient. unfortunately, periodontology has not yet discovered a therapy that will predictably treat local inflammation in these patients which are at risk for further pocketing, bleeding on probing, bone loss and ultimately, tooth loss. although cbd has been patented in various forms since the 1940s, its acceptance and availability to patients has only recently expanded exponentially. marketing of cbd to periodontal patients as a means to control inflammation is already commonplace online and in cbd-specific shops; it is the duty of periodontology to determine the efficacy and success of this known anti-inflammatory compound as it relates to clinical periodontal parameters. to determine if cbd is a successful adjunct to conventional periodontal inflammation control therapies would be a boon to the advancement of oral health and to millions of patients that could benefit from this treatment.

Eligibility criteria:
inclusion criteria: * diagnosis of chronic moderate-advanced periodontitis * one 6-9 mm interproximal probing depth * overall good systemic health * history of regular pmt exclusion criteria: * systemic disease that significantly affect periodontal inflammation and bone turnover * surgical periodontal therapy in the past year * pregnant/breast-feeding females.
preoperative weight loss for open abdominal wall reconstruction

Conditions: Abdominal Wall Hernia

Summary: the goal of this randomized controlled trial is to compare preoperative intensive weight management to upfront surgery in obese patients undergoing complex abdominal wall reconstruction. the main question is will abdominal wall specific quality of life (using the herqles survey) for the group undergoing upfront surgery be non-inferior compared to the group in the weight management program.

this is a prospective, single-center, registry-based, parallel, randomized controlled trial with 1:1 allocation. the study will consist of 2 arms: an intensive 6-month medical weight loss program prior to open retromuscular ventral hernia repair compared to upfront surgery without required weight loss. the medical obesity intervention will be conducted by physicians, nurse practitioners, and dieticians specializing in weight loss medicine. the study operations will be performed at cleveland clinic by six hernia surgeons with advanced abdominal wall reconstruction training.

Eligibility criteria:
inclusion criteria * adults having open retromuscular ventral hernia repair with an anticipated posterior component separation with transversus abdominis release and synthetic mesh * bmi 40-55 kg/m2 and who are not planning to pursue weight loss surgery for any of the following reasons: they are not a candidate for weight loss surgery, cannot pursue weight loss surgery for insurance reasons, or are not interested in pursuing weight loss surgery. exclusion criteria * lack of english language fluency * urgent need for repair as determined by surgeon judgement * pregnant patients * permanent stoma in place * isolated flank hernia * anticipated need for staged operation; for example, patients who will undergo a mesh excision separate from definitive reconstruction. * bmi \ 55 kg/m2 * inability to participate in the obesity management program due to lack of insurance coverage or history of mental illness (including eating disorders, schizophrenia, etc.). * obstructive symptoms
study of sintlimab maintenance therapy in patients with extensive small cell lung cancer

Conditions: Small Cell Lung Cancer; Extensive Disease; Adoptive Cellular Immunotherapy; Chemotherapy; Maintenance

Summary: small cell lung cancer is a highly aggressive malignancy. currently, there is no effective regimen for patients after the progression offirst-line chemotherapy. the prognosis of patients with extensive disease is very poor, and the improved therapeutic efficacy is urgently needed. most patients with small cell lung cancer have a long history of smoking, and the tumor mutation burden is relatively high, which provides potential for immunological checkpoint inhibitors represented by pd-1 antibodies. a number of studies have shown that chemotherapy combined with adoptive cellular immunotherapy could prolong the survival of patients. this study is a clinical study to explore the efficacy and safety of maintenance therapy with sintilimab after 4-6 cycles of first-line chemotherapy combined with adoptive cellular immunotherapy in patients with advanced small cell lung cancer.


Eligibility criteria:
inclusion criteria: * small cell lung cancer confirmed by pathology * extensive small cell lung cancer by imaging * at least one measurable lesion by recist 1.1 * ecog 0-1 * adequate organ function * no other severe diseases conflicting with this regimen (such as autoimmune diseases, immunodeficiency, organ transplantation, etc) * no history of other maliganancies * women of childbearing period must examinate for a negative pregnancy test within 7 days, use appropriate contraceptive measures during the study and 6 months after the trial. * agreement to participate in the study and signed informed consent from the patients exclusion criteria: * serious infectious diseases four weeks before enrollment * requirement intermittent use of bronchodilators or medical interventions; * the use of immunosuppressants before the enrollment, the amount of immunosuppressant used ≥10mg / day oral prednisone for more than 2 weeks; * severe allergies * severe mental disorders * abnormal coagulation function * previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, severe lung damage, etc. * other situations considered by investigators not meet the inclusion criteria (including but not limited to symptomatic brain metastases)
investigating the effects of cannabidiol on social anxiety disorder

Conditions: Phobia, Social

Summary: the purpose of this study is to test whether a single-dose of epidiolex (cannabidiol) is associated with reduced psychological, physiological, and neuroimaging measures of anxiety in people diagnosed with social anxiety disorder (sad).

using a randomized, double-blind, placebo-controlled, parallel-group study design, this scientific investigation will examine the effect of 3 milliliters (ml) of epidiolex (100mg cannabidiol/ml) on behavioral, physiological, and neuroimaging measures of anxiety in subjects diagnosed with sad. the study will enroll 50 subjects with sad who will be randomized in a double-blind manner to receive either epidiolex or placebo before experiencing the trier social stress test (tsst), the gold-standard for ethically inducing stress in a controlled laboratory setting. following the tsst, neuroimaging measures of emotional processing and self-referential processing will be acquired using functional magnetic resonance imaging (fmri). this study will be conducted primarily at massachusetts institute of technology with research and clinical support from massachusetts general hospital.

Eligibility criteria:
inclusion criteria: * ability and willingness to provide written informed consent. * sufficiently fluent in english to participate in the trial. * between 18-55 years of age (inclusive). * right-hand dominant. * current medications are stable for past 30 days (no changes to dose or frequency). * negative result on pregnancy test (if female). * negative result on urine drug screening. * current diagnosis of social anxiety disorder (quickscid-5). * liebowitz social anxiety scale (lsas ≥ 60). exclusion criteria: * history of bipolar disorder, schizophrenia, psychosis, delusional disorders. * history of eating disorder within past 6 months. * history of any traumatic brain injury. * currently diagnosed with diabetes mellitus. * presence of severe medical illness that would prevent completion of study procedures. * presence of significant neurological illness or cognitive dysfunction (e.g.; seizures, dementia). * history of substance use disorder within past 6 months (other than nicotine and caffeine). * use of any cannabis-containing products in past 30 days (cbd or thc). * use of beta-blockers or benzodiazepines in past 2 weeks. * history of claustrophobia. * contraindications for mri (e.g.; shrapnel). * presence of any other medical condition that, in the investigator's opinion, may interfere with the study procedures. * use of concomitant medication that has a strong interaction with cyp3a4 or cyp2c19 (as assessed through lexicomp). * history of liver disease. * history of hypersensitivity to cannabinoids. * history of hypersensitivity to sesame seed oil. * currently breastfeeding (if female).

Keywords: social anxiety disorder cannabidiol fmri
tilt of the intraocular lens in patients undergoing combined phacoemulsification and vitrectomy with airtamponade

Conditions: Epiretinal Membrane

Summary: vitrectomy with membrane peeling has developed to be the gold-standard in treatment of epiretinal membranes. due to the possibility of vitrectomy induced cataract, in many ophthalmic surgical centers it has become usual to indicate combined phacoemulsification and vitrectomy in case of existing cataract. epiretinal membranes (erm) and pseudomaculaforamen are disorders involving the posterior pole of the eyeball with consecutive vision loss. erm can be well visualized with spectral domain optical coherence tomography (sd-oct). different study groups showed that even intraoperative use of sd-oct is possible.

the aim of the study is to document tilt of the intraocular lens in combined phacoemulsification and vitrectomy by photography of purkinjereflexes. during vitrectomy tamonade with air or saline are regarded as equal in substituting the removed vitreous. in case of airtamponade, air will be resolved within several days. as airtamponade induces more anterior movement of the implanted intraocular lens in the superior parts of the lens, tilt can result. saline doesn´t have any influence on the intraocular lens.

Eligibility criteria:
inclusion criteria: * patients sheduled for combined phakoemulsification and 23g pars plana vitrectomy * minimum age of 21 years * written informed consent exclusion criteria: * none
rct ventralex vs onlay mesh in incisional hernias

Conditions: Incisional Hernia of Midline of Abdomen

Summary: a radomised controlled trial comparing ventralex patch and progrip mesh in surgery for midline incisional hernias

incisional hernias in the midline is among the most common conditions requiring surgery. there are several factors which can increase the risk of incisional hernias, e.g. surgical technique, truncal obesity and other co-morbidities. repair with mesh-reinforcement is considered standard for the treatment of incisional hernias. onlay and sublay mesh placements are the most commonly used methods. there are many different types of mesh available to use. despite the widely use of composite ventral-patch ventralex, there are few studies with small numbers of patients showing the advantage and disadvantage of ventral-patch. some studies show that the onlay mesh-reinforcement remains a good alternative to the sublay mesh technique, while others showing fewer recurrences with the sublay mesh technique. the ventralex mesh is usually placed on the peritoneum as a intra peritoneum onlay mesh (ipom). in this study intend to compare pre peritoneal ventralex® mesh in sublay position with progrip self-fixating onlay mesh.

Eligibility criteria:
inclusion criteria: * hernia defect 1-4 cm * incisional hernia or recurrent hernia after previous primary hernia repair * bmi \<35 * age 18-100 years exclusion criteria: * defect size\>4 cm * ongoing pregnancy * bmi\>35 * primary hernia
reducing children's anxiety using homeopathic remedy before dental treatment

Conditions: Children's Dental Anxiety

Summary: pharmacological interventions to aid behavior management's techniques are commonly used in pediatric dentistry. the aim of the medicaments is to control behavior and allow safe completion of a dental procedure. homeopathic remedy is safe and can be effective to control behavior and decrease anxiety in children during dental treatment. aim: 1. to explore the efficacy of homeopathic drugs in decreasing children's dental anxiety before dental treatment. 2. to assess the effectiveness of homeopathic remedy in facilitating dental treatment for anxious children. methods: prospective, double-blind study. thirty healthy children (5-12 years-old) will receive homeopathic remedy\\placebo before dental treatment. anxiety reduction will be measured using: saliva cortisol levels, saliva α-amylase levels, facial image scale (fis), and houpt behavior scale. expected results: the homeopathic remedy will reduce anxiety and increase child cooperation during dental treatment.


Eligibility criteria:
inclusion criteria: * dental anxiety * needs at least 2 dental treatment appointments exclusion criteria: * medically compromised * cooperative, needs less than 2 dental treatment appointments
personalized antidepressant adherence strategies for depressed elders

Conditions: Depression

Summary: the study is a randomized controlled trial to test the usefulness of a brief intervention to improve adherence to antidepressant medication prescribed to older adults in a primary care setting. study will be conducted at weill cornell and university of michigan.

the intervention is a brief, psychosocial intervention designed to be an adjunct to pharmacotherapy prescribed by a primary care physician. it includes psychoeducation, problem solving and development of goals and a personalized adherence strategy. the intervention includes three 30 minute sessions during the first 6 weeks of treatment and a follow-up phone call two weeks later.

Eligibility criteria:
inclusion criteria: age: 65 and older; newly prescribed antidepressant medication by pcp (within past 10 days); has not been prescribed antidepressant medication in previous 6 months. exclusion criteria: high suicide risk, i.e. intent or plan to attempt suicide presence of alcohol abuse, substance abuse, psychotic disorder or, bipolar disorder as observed on the scid, are excluded; dementia: mmse below 24, clinical assessment, or medication; inability to speak english; aphasia interfering with communication; terminal illness or current chemotherapy -

Keywords: older adults adherence antidepressant depression
statseal vs figure-of-eight suture for vascular closure in af ablation

Conditions: Atrial Fibrillation (AF); Vascular Access

Summary: this study, titled aims to compare two vascular closure techniques after catheter ablation for atrial fibrillation (af). catheter ablation is a common procedure used to treat af, but after the procedure, it is important to close the access site in the blood vessel to prevent bleeding. this study will evaluate whether the statseal device, a haemostatic disc, can help patients recover more quickly compared to the traditional figure-of-eight suture technique. the primary objective of the study is to determine whether statseal reduces the time it takes for patients to start walking after the procedure (known as time to ambulation). secondary objectives include comparing the time to complete haemostasis, discharge eligibility, incidence of adverse events, and patient comfort between the two techniques. participants in the study will be randomly assigned to receive either the statseal device or the figure-of-eight suture after their af ablation procedure. the study will recruit 160 participants across multiple hospital sites, with 80 participants in each group. both techniques are standard methods, and participants will be closely monitored for safety throughout the study. by comparing these two closure techniques, the study aims to improve the recovery process for patients undergoing af ablation and provide evidence on which method leads to better outcomes and patient experiences.


Eligibility criteria:
inclusion criteria: * male and female patients age \&gt;18 * elective catheter ablation for atrial fibrillation using a 6 to 14 fr inner diameter introducer sheath with a minimum of 1 and maximum of 3 femoral venous access sites * willing and able to give informed consent exclusion criteria: * active systemic or cutaneous infection, or inflammation in vicinity of the groin * platelet count \&lt; 100,000 cells/mm3 * bmi \&gt; 45 kg/m2 or \&lt; 20 kg/m2 * attempted femoral arterial access or inadvertent arterial puncture * procedural complications that interfered with routine recovery, ambulation, or discharge times * incorrect sheath placement * intraprocedural bleeding or thrombotic complications * access site-specific eligibility criteria to exclude problems with gaining access or location of sheath * history of bleeding diathesis, coagulopathy, hypercoagulability, or thromboembolic events

Keywords: atrial fibrillation vascular closure statseal
medical review: hand surgery after local block versus non-block

Conditions: Carpal Tunnel Syndrome

Summary: in this study, the effects of local block vs non block will be assessed with respect to postoperative outcomes (such as pain score, and recovery profiles) in outpatients after hand surgery.

analyzing medical records and through a telephone questionnaire, in a retrospective and prospective review respectively.

Eligibility criteria:
inclusion criteria: * 18-80 years old * outpatients who underwent hand surgery under peripheral nerve block or local infiltration alone exclusion criteria: * patients who do not meet inclusion criteria

Keywords: pain management ambulatory surgery opioid local anesthesia hand surgery postoperative pain