Kornimate/medical-research-clean huggingface dataset:
impact of maternal vitamin a or beta-carotene supplementation on maternal and infant mortality in bangladesh

Conditions: Vitamin A Deficiency; Maternal Mortality; Infant Mortality

Summary: the purpose of this trial is to determine whether providing women with a weekly oral supplement of vitamin a, either preformed or as beta-carotene, at a dosage equivalent to a recommended intake from early pregnancy through three months postpartum, can reduce the risk of maternal mortality, fetal loss, or infant mortality.

maternal mortality and vitamin a deficiency coexist in rural south asia. in nepal, weekly supplementation with vitamin a or beta-carotene during the child-bearing years reduced all-cause maternal mortality and, in night blind women, also infant mortality. the present trial is testing the efficacy of the same supplements from \~9 weeks' gestation to 12 weeks postpartum. the planned sample size is 68,000 pregnancies. it is being conducted in 19 rural unions, covering an area of \~750 sq km with a population of \~580,000 in gaibandha and southern rangpur districts in northern bangladesh. the study area was mapped as 596 "sectors" (unit of randomization), each comprising 200-275 households; \~135,000 houses were numerically addressed and, at the outset, 103,000 women were listed. women are visited at home every 5 weeks by 596 trained female staff to detect pregnancy by a combination of menstrual history and urine testing. newly married women are prospectively enlisted for pregnancy surveillance. following informed consent urine-positive (pregnant) women detected during surveillance are enrolled to receive weekly a capsule containing 7000 retinol equivalents of preformed vitamin a, 42 mg of beta-carotene or placebo. vital events are recorded weekly through 3 months postpartum. trained interviewers conduct maternal nutritional and health and household socioeconomic assessments in the 1st trimester. at 3 months postpartum, interviewers assess both mother and infant for health and nutritional status, including apparent birth defects that are later physician-confirmed. an additional home health assessment occurs at 6 months post partum, and vital status is recorded for mother and infant at one year postpartum. a \~3% subsample of enrolled pregnant women participate in a substudy involving enhanced clinical, anthropometric, biochemical, body compositional, morbidity and interview-based assessment protocols in the 1st, 2nd and 3rd trimesters, and at 3 months post-partum. reported maternal and infant deaths are verified and causes ascertained during "verbal autopsy" interviews with family members of the deceased.

Eligibility criteria:
inclusion criteria: * married women of reproductive age * first pregnancy during time period of trial exclusion criteria: * premenarchial girls * married women with a previous pregnancy enrolled into the trial * previously married women who have moved into the study area * single women (never married, widowers) * women who are sterilized (or whose husbands are sterilized) * menopausal women

Keywords: maternal mortality infant mortality vitamin a beta-carotene micronutrients bangladesh neonatal mortality
cognitive behavioral therapy for anxiety and depression in copd

Conditions: Anxiety; Depression; Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study was to examine the efficacy of manualized, short-term group cognitive behavioral therapy for copd patients suffering from clinically significant symptoms of anxiety and/or depression.

anxiety and depressive disorders have been demonstrated in 16-50% of patients with chronic obstructive pulmonary disease (copd), and clinically significant levels of anxiety or depressive symptoms seem to be even more common.despite the multiple, severe consequences, majority of copd patients with co-morbid anxiety or depression do not seem to receive any treatment for the psychological disturbance. cognitive behavioral therapy (cbt) is a well-known approach for treating anxiety and depression, and data has demonstrated effectiveness of cbt for older individuals with anxiety. cbt has also improved exercise tolerance compliance in copd patients, and pilot studies using cbt components have shown effectiveness in improving mental health and functional status for patients with copd. given the increasing number of patients suffering from copd and the high prevalence of anxiety and depression in the population, the current study was designed to examine the efficacy of cbt in groups for anxiety and depression in patients with copd. at present, cbt-based interventions focusing on mental health symptoms are not widely available for copd patients, and the potential of cbt for improving emotional well-being is not systematically considered in existing treatment alternatives. the study expands the findings from previous pilot studies by focusing on copd patients with clinically significant levels of anxiety and depression. the wide breadth of coping skills included in the cbt intervention target symptoms of both anxiety and depression, and thus the utility of the intervention for managing mental health symptoms is not restricted to any specific dsm-iv diagnosis.

Eligibility criteria:
inclusion criteria: * 40 years or older * scores of 16 or higher on the beck anxiety inventory and/or 14 or higher on the beck depression inventory ii * copd diagnosis exclusion criteria: * participation in other studies likely to influence the patient in terms of confounding effects * signs of cognitive impairment defined by a score of less than 23 on the mini-mental state examination * presence of psychotic disorders, non-nicotine substance use disorders, bipolar disorders, or suicidal intentions as identified by clinical assessment based on the structured clinical interview for the diagnostic and statistical manual of mental disorders, fourth edition (scid-i/p) * having a serious somatic condition preventing active participation in the present study

Keywords: chronic obstructive pulmonary disease anxiety depression cognitive behavioral therapy
comparative study between immediate surgery versus neoadjuvant chemotherapy for management of resectable pancreatic cancer

Conditions: Surgery; Neoadjuvant Chemotherapy; Management; Resectable Pancreatic Cancer

Summary: this trial aimed to determine whether neoadjuvant chemoradiotherapy improves overall survival compared with upfront surgery, both followed by adjuvant chemotherapy in patients with resectable and borderline resectable pancreatic cancer.

pancreatic cancer is one of the solid cancers with the poorest treatment outcomes, and there is an urgent need to improve its treatment outcomes. among these, resectable pancreatic cancer is known to show relatively good treatment outcomes with surgical resection, but the 5-year survival rate is still about 20%, which is still unsatisfactory. neoadjuvant therapy may increase the proportion of patients that actually receive chemotherapy and thereby improve survival. furthermore, neoadjuvant therapy may increase the microscopically margin-negative (r0) resection rate and may identify patients with rapidly progressive disease who can be spared futile surgery.

Eligibility criteria:
inclusion criteria: * computed tomography (ct) with pancreatic protocol + vascular mapping * histopathologically proven malignant by ct-guided or endoscopic ultrasound (eus)-guided biopsy resectable pancreatic cancer means no contact of the tumor with the superior mesenteric artery, celiac axis \& common hepatic artery, and contact of the tumor but ≤90° contact with the superior mesenteric vein \& portal vein. exclusion criteria: * borderline resectable \& locally advanced pancreatic cancer * tumor at the tail of the pancreas. * metastatic pancreatic cancer * unfit patients for surgery.
study of nv-101 for safety and efficacy in pediatric dental patients undergoing procedures

Conditions: Anesthesia, Dental

Summary: this phase 2 clinical study is designed as a multicenter, randomized, blinded, controlled study to evaluate the safety and efficacy of nv-101 in approximately 150 children 4 to 11 years of age. nv-101 or sham injection is administered at the completion of a dental procedure requiring local anesthesia with 2% lidocaine with 1:100,000 epinephrine. the dental procedure(s) shall be performed in a single quadrant of the mouth and include cavity preparation, restoration/filling, teeth cleaning (non-surgical scaling and/or root planing), or crowns.


Eligibility criteria:
inclusion criteria: * male or female, 4 to 11 years of age * sufficiently healthy, as determined by the investigator, to receive routine dental care * requires a restorative procedure such as cavity preparation, or such as teeth cleaning (non-surgical scaling and/or root planing) in a single quadrant of the mouth * requires local anesthesia with 2% lidocaine with 1:100,000 epinephrine administered by submucosal injection * dental procedure(s) completed with 60 minutes of injection of local anesthetic * can be trained to complete the wong baker pain rating scale * for subjects 6 to 11 years of age who are trainable in standardized palpation procedure: * have normal lip sensation at baseline prior to administration of local anesthetic * have numbness of the relevant lip quadrant at completion of the dental procedure * negative urine pregnancy test at screening in female subjects who are past menarche * subjects give written or verbal assent, as applicable, and parents(s) or legal guardian(s) give written informed consent exclusion criteria: * weight less than 15 kg * history or presence of any condition that contraindicates routine dental care or use of local anesthetic * requires more than half cartridge of local anesthetic if weight is greater than or equal to 15 kg and less than 30 kg and more than one cartridge of local anesthetic if weight is greater than or equal to 30 kg, excluding supplemental injections * allergy or intolerance to lidocaine, epinephrine, sulfites, phentolamine, or topical benzocaine * has used any investigational drug and/or participated in any clinical study within 30 days of study drug administration * has participated in this study or any previous study of phentolamine mesylate for reversal of local soft tissue anesthesia (sta) * use of opioid-like analgesics within 24 hours prior to administration of local anesthetic * requires the use of local anesthetic other than lidocaine/epinephrine to perform the scheduled dental procedure * requires the use of nitrous oxide or sedatives to perform the scheduled dental procedure * any condition which, in the opinion of the investigator, increases the risk to the subject of participating in the study or decreases the likelihood of compliance with the protocol

Keywords: soft tissue anesthesia (numbness)
social dominance, gender, and cardiovascular reactivity

Conditions: Cardiovascular Diseases; Heart Diseases; Coronary Disease

Summary: to examine biopsychosocial processes that might contribute to the associations among social dominance, gender, and cardiovascular reactivity,.

background: social dominance, the tendency to exercise social influence and control, has been positively associated with coronary heart disease (chd) risk among males, independent of biomedical risk factors and hostility. exposure to dominant others behaviors also has been associated with elevated chd risk. for females, submissiveness and a constellation of psychosocial behaviors opposite to urgency and competitiveness have been associated with increased risk for cardiovascular disease (cvd). the studies extend a growing literature concerning the central role of social relationships in health and illness and they test a theoretical model that addresses why social relationships and interpersonally-oriented person variables such as dominance may have differing consequences for the physical well-being of men and women. design narrative: the three studies were designed to test a social-contextual model of dominance and cardiovascular stress reactivity (cvr) that synthesized and elaborated earlier models in order to account for (1) cardiovascular consequences of exposure to dominant others and (2) differences in dominant men's and women's cardiovascular responses to social interactions. because of the disproportionately high rates of cvd among black americans, both black and white men and women were included in the studies. using a laboratory social interaction paradigm, study 1 refined and validated a coding system designed to assess dominant and hostile behaviors during dyadic social interaction. study 2 examined two factors proposed to account for differences in dominant men's and women's cardiovascular responses to social interaction: (1) explicit role demands regarding dominance expression (i.e., the degree to which situations provided clear and salient cues regarding expected and acceptable behavior) and (2) gender composition of the dyad (i.e., same sex versus opposite sex). these two factors were manipulated independently while unacquainted, healthy young adult men and women participated in task-oriented dyadic discussions designed to activate motives to influence; cardiovascular responses were measured during the discussions and preceding rests. study 3, a secondary analysis of data collected in study 2, examined associations between cvr and exposure to others' dominance. the aforementioned behavioral coding system was used to assess behavioral dominance observed in study 2 and path analytic techniques were used to model associations among cvr, one's own and one's partner's trait and behavioral dominance, gender, and situational factors. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
safety, tolerability, pharmacokinetics, radiation dosimetry, and pet imaging properties of 89zr-labeled hnd2 (nmk89) in patients with pancreatic cancer

Conditions: Pancreatic Cancer

Summary: this trial will be a non-randomized, phase i trial to evaluate safety, tolerability, biodistribution, radiation dosimetry, pharmacokinetics and pet imaging properties following an infusion of 37 mbq (1 mci) of 89zr-labeled hnd2\* (nmk89) in patients with pancreatic cancer that are positive for muc5ac. image acquisition is conducted using a pet/ct machine. \* hnd2: recombinant humanized nd2 (anti-human muc5ac monoclonal antibody)


Eligibility criteria:
inclusion criteria: 1. willing and able to provide informed consent. 2. male or female ≥ 18 years of age. 3. histologically confirmed diagnosis of pancreatic adenocarcinoma. 4. willing to provide biopsy specimens for purposes of confirmation of muc5ac expression. 5. confirmed muc5ac expression at pre-screening. 6. measurable disease. 7. female patients of child-bearing potential must have a negative serum pregnancy test within 30 days prior to infusion of nmk89. 8. willing to comply with the study protocol requirements. 9. willing to provide a tumor resection specimen or biopsy specimen, if the patient undergoes tumor resection or biopsy between day 16 and day 60. exclusion criteria: 1. known hypersensitivity to the investigational medicinal product (imp) or any of the excipients. 2. history of another primary cancer within the 2 years prior to enrollment, except for the curatively treated in situ cancers. 3. exposure to any investigational treatments within 30 days prior to the planned date of infusion of nmk89. 4. ongoing toxicity ≥ grade 2. 5. pleural effusion or peritoneal fluid ≥ grade 3. 6. active hepatitis b, hepatitis c, hiv, or other progressing infectious disease. 7. uncontrolled diabetes. 8. autoimmune disease or idiopathic thrombocytopenic purpura. 9. exposure to any radiopharmaceuticals. 10. planned antineoplastic therapies on the planned date of nmk89 infusion. 11. use of bevacizumab or any other anti-angiogenic agent. 12. uncontrolled intercurrent illness. 13. ecog ps: ≥ 2. 14. participants do not have adequate organ and marrow function. 15. female patients that are pregnant or breast-feeding. 16. positive urine screen for illegal drugs, or abuse of prescribed drugs at screening. 17. participants with contraindications to contrast agent injection used for diagnostic ct. 18. deemed inappropriate to participate by the investigator.

Keywords: pancreatic cancer muc5ac
battlefield acupuncture for pain in hidradenitis suppurativa

Conditions: Hidradenitis Suppurativa

Summary: the investigators will investigate battlefield acupuncture as a treatment for the pain of hidradenitis suppurativa.

participants will report their pain level daily for 4 weeks. at week 2 and 3, they will get acupuncture in the ears.

Eligibility criteria:
inclusion criteria: * age 18 years or older * dermatologist-confirmed diagnosis of hidradenitis suppurativa * significant pain from hidradenitis at least twice weekly * stable treatment regimen for hidradenitis during study period exclusion criteria: * disease or disfigurement of the ear that prevents battlefield acupuncture of the ears * other chronic pain that will interfere with the ability to rate hidradenitis pain

Keywords: acupuncture pain battlefield acupuncture hidradenitis
surgical treatment of ddh with and without capsulorrhaphy

Conditions: Developmental Dysplasia of the Hip

Summary: the goal of this interventional study is to evaluates the surgical treatment outcomes of developmental dysplasia of hip with and without capsulorrhaphy between 1-6 years of age . it compares the effectiveness of these approaches in improving postoperative stability , range of motion , and long-term success rates for ddh patients undergoing surgery .:


Eligibility criteria:
inclusion criteria: 1. age: from 1 year to 6 years 2. sex: males and females 3. children who received no operative treatment before. exclusion criteria: 1. children who were treated operatively before presentation. 2. children who had teratologic, post septic or neuromuscular hip dislocation.
adaptation process of patient-reported outcomes, an evaluation study

Conditions: Chronic Disease

Summary: objectives: to identify the respective contributions of back-translations and of the expert committee in the process of cultural adaptation of patient reported outcome with an experimental design in the adaptation process : four translations of a questionnaire will be produced: * a simple translation by two translators, who serves as the basis for the three other translations * a translation made with the use of a back-translation. * a translation with review by an expert committee. * a translation the use of a back-translation and review by an expert committee. properties of each translation will be analyzed and compared


Eligibility criteria:
inclusion criteria: * adult (other 18 years) * able to read, understand and answer the adapted questionnaire * having a medical condition targeted by the questionnaire
interfuse® s and t for the treatment of scoliosis, spondylolisthesis and degenerative disc disease (ddd)

Conditions: Scoliosis; Back Pain

Summary: the primary objective of this prospective, post-market study is to collect data to assess the long term outcome of a broad contact modular interbody device in the form of the interfuse s™ or interfuse t™ device in patients undergoing long construct fusion for degenerative disc disease and/or scoliosis. comparisons will be made with published historical data..

the primary objective of this prospective, post-market study is to collect data to assess the long term outcome of a broad contact modular interbody device in the form of the interfuse s™ or interfuse t™ device in patients undergoing long construct fusion for degenerative disc disease and/or scoliosis. while there is no concurrent control population, there is ample historical control data to be used for comparison. the study will include up to two hundred (200) patients, up to 10 centers, and provide a prospective evaluation of the interfuse "t" and/or interfuse "s" interbody fusion system. primary endpoints will be assessed at twelve months post-surgery. all patients enrolled in the study will be followed for at least 24 months.

Eligibility criteria:
inclusion criteria: * 1. the patients has a planned fusion construct of at least five levels and will have the interfuse (s) or (t) planned for l5-s1 and/or l4-l5. 2. the patient has documented conservative (non-operative) treatment for at least 6 months. 3. the patient has a vas score of ≥ 60 mm for back and/or leg. 4. the patient has an odi ≥ 40%. 5. the general condition of the patient is appropriate for surgery, as evaluated by the investigator. 6. the patient is willing and able to comply with study requirements. 7. the patient has agreed to participate in the study exclusion criteria: * 1. the patient has undergone any prior spinal fusion surgery at the proposed treatment level(s). previous non-fusion surgery at the proposed treatment level(s) is acceptable. 2. the patient has osteoporosis or severe osteopenia as determined by the investigator. a clinical score calculator may be utilized for females over 40 years of age. 3. the patient has grade 2 or higher spondylolisthesis or retrolisthesis at the affected level(s). 4. the patient has known neoplastic disease other than skin cancer. 5. the patient has a body mass index (bmi) of greater than 40; bmi = wt (kg)/ht2 (m2). 6. the patient has an active infection. 7. the patient is pregnant or is planning on becoming pregnant in the next two years. 8. the patient is mentally ill or has a history of drug abuse or severe depression/ psychosocial issues. 9. the patient has a known allergy to polyether ether ketone (peek), stainless steel or tantalum. 10. the patient is currently enrolled in an investigational spine study. 11. the patient has rheumatoid arthritis, ankylosing spondylitis or other autoimmune disease. 12. the patient has symptomatic fibrous arachroiditis.

Keywords: intervertebral disc degeneration bone disease musculoskeletal disease spinal disease
"safety in dementia": an online caregiver intervention

Conditions: Caregivers; Decision Making; Alzheimer Disease; Social Media; Safety; Suicide

Summary: in an online randomized trial of safety in dementia with national recruitment and longitudinal follow-up, we will recruit informal caregivers of community-dwelling adults with dementia who have firearm access.

aim 1: to test the efficacy of safety in dementia (sid) on firearm safety decision quality and behaviors, among a national sample of informal caregivers of community-dwelling people with dementia and firearm access (n=500). aim 2: to compare varied methods in reaching informal caregivers. aim 3: to explore stakeholder longitudinal experiences with sid and firearm-related decisions.

Eligibility criteria:
inclusion criteria: * live in united states * speak english or spanish * informal caregiver for community swelling person with dementia and firearm access * access to the internet exclusion criteria: * in legal custody or institutionalized