Kornimate/medical-research-clean huggingface dataset:
evaluation of naltrexone as a treatment for self-injurious behavior

Conditions: Self-injurious Behavior; Self Mutilation

Summary: the proposed study examines the effect of oral naltrexone on self-injurious behavior (sib) in adolescents and adults of normal intelligence.

the proposed study examines the effect of oral naltrexone on self-injurious behavior (sib) in adolescents and adults of normal intelligence. it is designed as a pilot study and will provide preliminary data for a larger scale clinical trial if found to be effective in the pilot study.

Eligibility criteria:
inclusion criteria: * thirteen years of age or older * actively engaged in sib at a rate of, on average, at least two events per week for at least 3 months * has internet access in a secure and private manner * lives within a reasonable distance from kalamazoo (to make the five clinic visits convenient) and plans to remain in the area throughout the next 4-5 months exclusion criteria: * under the age of 13 * currently pregnant (confirmed with initial urine pregnancy test), lactating, or planning to become pregnant in the next 4 months * active hepatitis or liver disease * prior history of recently active opioid dependence * current prescription, non-prescription, or illicit opioid use, (i.e., acute use within the past 14 days or chronic use within the last 30 days), including all opioid analgesics, certain cough and cold remedies (e.g., codeine), and certain anti-diarrheal preparations (e.g., loperamide). currently taking an opioid antagonist for alcohol or opioid dependence or having taken one in the last 14 days * current use of leflunomide (arava), droperidol (droleptan), diazepam (valium), thioridazine (mellaril, novoridazine, thioril) (26) * any report of clinically significant medical condition or medication regimen which might cause undue risk or affect ability to participate in this clinical trial * on initial laboratory examination, alanine aminotransferase (alt) or aspartate aminotransferase (ast) levels more than one standard deviation (sd) above the upper limit of normal * unable to meet a 22-week requirement to log journal entries daily, to be available by phone a minimum of once weekly during the first month, and to be present at clinical sites once every three weeks for 12 weeks, for a total of 5 visits * infrequent sib, lack of secure internet access, or living a significant distance from the kalamazoo area (does not meet inclusion criteria) * unwilling or parent/guardian unwilling to participate in research requirements.

Keywords: self-injurious behavior self mutilation naltrexone
acandis credo intracranial stent for unsuccessful recanalization after thrombectomy (acute)

Conditions: Acute Ischemic Stroke; Intracranial Stenosis

Summary: study objective is to evaluate the efficacy and safety of acute permanent stenting of symptomatic intracranial stenosis following unsuccessful recanalization by thrombectomy in acute ischemic stroke with large vessel occlusion using the self-expandable credo® stent together with the neurospeed® pta balloon catheter.

prospective, interventional treatment, single-arm, open-label, multi-center trial.

Eligibility criteria:
inclusion criteria: * acute ischemic stroke from large vessel occlusion (lvo) * failed recanalization after treatment with thrombectomy, i.e. persistent occlusion of intracranial internal carotid artery (ica), proximal segment (m1, m2) of the middle cerebral artery (mca) (tici 0-1) * small to moderate infarct core prior to initiation of thrombectomy (ct aspects 6-10, dwi lesion \< 70 ml) * suspected underlying stenosis of the occluded artery amenable to stenting by judgement of the treating neurointerventionalist * age 18- 80 years * informed consent (see below) * decision to perform angioplasty and stenting \< 12 hours of symptom onset * previous passage of occlusion with microcatheter obtained exclusion criteria: * large infarct core prior to initiation of thrombectomy (ct aspects 0-5, dwi lesion \> 70 ml) * vessel occlusion or stenosis of different known or suspected cause than atherosclerosis (e.g. vasculitis) * pre-stroke disability (mrs \> 2) * any sign of intracranial haemorrhage on brain imaging prior to thrombectomy * any sign of intracranial vessel perforation during thrombectomy * contraindication against treatment with double anti-platelet treatment * current effective use of oral anticoagulants (e.g. inr \> 1.7 for vitamin k antagonists) * more than 3 attempts for recanalization of target lesion prior to the use of the study device. * stenosis longer than the working length of the neurospeed pta balloon catheter. * diameter of the healthy vessel proximal and distal to the stenosis prevents save treatment with the neurospeed pta balloon catheter or is outside the indicated range of the credo stent. * diameter of the target area is outside the indicated range of the credo stent after predilation. * contraindication against anti-platelet or anticoagulation therapy * heavily calcified lesions that may prevent access or safe stent placement. * pregnant and breastfeeding women
contrast-enhanced ultrasound imaging for diagnosing recurrent renal cell carcinoma (rcc) post ablation

Conditions: Recurrent Renal Cell Carcinoma; Renal Cell Carcinoma

Summary: this phase ii trial studies how well contrast-enhanced ultrasound (ceus) works for diagnosing patients with renal cell cancer (rcc) that has come back (recurrent) after an ablation. diagnostic imaging, such as ceus, may help find and monitor long term renal cell cancer recurrence following cryo or microwave ablation.

primary objective: i. to characterize and compare the sensitivity, specificity, positive and negative predictive value, and inter-reader agreement of 2d contrast-enhanced ultrasound (ceus) and contrast-enhanced computed tomography (ct)/magnetic resonance imaging (mri) for detecting recurrent or residual renal cell carcinoma (rcc) following ablation, using a combination of standard of care imaging follow-up and tissue pathology as a reference standard. secondary objectives: i. to evaluate the potential improvement to the qualitative assessments of 2d ceus when fused with the patient's pre-treatment cross sectional imaging. ii. to assess the potential added value of using multi-modality volumetric ceus for detecting rcc recurrence post ablation. iii. to explore the use of quantitative imaging parameters extracted from 2d/3d ceus datasets to determine if this improves the overall performance of ceus. exploratory objective: i. an advanced doppler technique designed for detection of slower flow will also be investigated as a non-contrast based approach for detecting recurrent disease. outline: patients receive lumason intravenously (iv) and undergo ceus imaging with mri/ct on study. patients' electronic medical record is reviewed every 6 months throughout study.

Eligibility criteria:
inclusion criteria: * previously received cryotherapy or microwave therapy of rcc * has available contrast enhanced (ce)-mri or ce-ct imaging prior to ablative therapy * have previously had or are scheduled to have a contrast-enhanced mri/ct for the monitoring of rcc recurrence within 4 weeks of the ceus study * be at least 18 years of age * be medically stable * if a female of child-bearing age, must have a negative pregnancy test * have signed informed consent to participate in the study exclusion criteria: * patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable * patients with known sensitivities to the components of lumason
foto: five consecutive days on treatment with efavirenz, tenofovir, and emtricitabine followed by two days off treatment versus continuous treatment

Conditions: HIV Infections

Summary: for people with hiv who are currently taking specific medications (including sustiva (efavirenz)) and have no detectable viral load, this study tracks how patients do if they take their medications for five days of the week compared with seven days of the week.

the purpose of this study is to evaluate virologic control of a weekly schedule of 5 days of treatment followed by two days off treatment versus continuous treatment with the same regimen. this is a larger study based on the results of our successful pilot study using the same protocol. the 48 week, phase iv trial addresses the issues of the high cost of hiv treatment, adherence problems associated with daily treatment, and cumulative toxicities. virologic and immunologic parameters, drug levels of efavirenz, adherence, and toxicity will be measured. subjects will have to be seen at cri for 6 visits after randomization. subjects randomized to daily therapy will cross over to 5/2 therapy at 24 weeks if their viral load remains undetectable.

Eligibility criteria:
inclusion criteria: * age 18 years or older * cd4 count \> or = 200 * viral load \< 50 * treatment with a regimen containing efavirenz and tenofovir and lamivudine or emtricitabine for at least 90 days prior to screening exclusion criteria: * detectable hiv rna on an ultrasensitive assay within the 90 days preceding screening * prior evidence of intermediate or high level resistance to efavirenz, tenofovir or cytidine analogues * hepatitis b infection

Keywords: hiv/aids efavirenz tenofovir emtricitabine foto treatment interruption atripla truvada treatment experienced
total versus subtotal hysterectomy:a randomised, prospective multicentre study of the effect on urinary, sexual and bowel function

Conditions: Hysterectomy

Summary: background it is uncertain whether subtotal abdominal hysterectomy results in better bladder, bowel, or sexual function than total abdominal hysterectomy. methods the investigators conducted a randomized, double-blind trial comparing total and subtotal abdominal hysterectomy in 279 women referred for hysterectomy because of benign disease; most of the women were premenopausal. the main outcomes were measures of bladder, bowel, and sexual function at 12 months. the investigators also evaluated postoperative complications.


Eligibility criteria:
inclusion criteria: * women having abdominal hysterectomy for benign conditions of the uterus exclusion criteria: * suspected cancer * a body weight that exceeded 100 kg * previous pelvic surgery * known endometriosis * abnormal cervical smears, * symptomatic uterine prolapse * symptomatic urinary incontinence

Keywords: total hysterectomy subtotal hysterectomy urinary function bowel function sexual function quality of life psychological function
a study of meaning-centered psychotherapy for caregivers to people with cancer

Conditions: Caregiver Burden; Caregiver Burnout; Caregiver Stress Syndrome

Summary: participants will complete 1 set of questionnaires about 2 weeks before beginning their meaning-centered psychotherapy for caregivers/mcp-c or standard supportive psychotherapy for caregivers/sp-c sessions. these questionnaires will ask about participants' sense of meaning and purpose in life, spiritual well-being, depression and/or anxiety, and social support. participants will then be assigned to receive either mcp-c or sp-c for 7 sessions. participants will complete additional sets of questionnaires about 2 weeks, 6 months, and 12 months after their last session of mcp-c or sp-c. it will take between 35 and 50 minutes to complete each set of questionnaires. after participants complete the mcp-c or sp-c sessions and all 4 sets of questionnaires, their participation in this study will end. if participants decide not to complete all 7 sessions, they may still choose to complete the questionnaires. participants may remain in the study and continue to receive all 7 sessions of mcp-c or sp-c even if their loved one passes away.


Eligibility criteria:
inclusion criteria: * age 18 or over; * as per self-report, a current caregiver to a patient with stage iii or iv solid tumor cancer currently receiving medical care of any kind (e.g., curative, palliative); * experiences distress as evidenced by a score of 4 or greater on the distress thermometer (dt) and an indication that this distress is associated with caregiving; * as per self-report, can read and understand english; * as per self-report, residing in new york, new jersey, or florida, or have the ability to complete sessions while complying with current telehealth regulations. exclusion criteria: * participant does not have a reasonable understanding of the study activities by the judgment of the consenting professional; * engagement in regular individual psychotherapeutic support that the participant is unable or unwilling to put on hold for the course of treatment.

Keywords: caregiver caregiver stress syndrome caregiver burden caregiver burnout memorial sloan kettering cancer center 23-376
comparison of duofertility, ladycomp/babycomp and clearblue monitors

Conditions: Infertility

Summary: comparative study to determine whether several fertility monitoring products - the duofertility monitor, the ladycomp/babycomp monitor and clearblue ovulation tests - are substantially equivalent in performance, and secondarily to determine the appropriateness of labeling information for the duofertility monitor.

the investigators plan to recruit 30 women who are currently trying to conceive, and ask them to use the 3 fertility monitors for duration of 3 menstrual cycles. additionally, during the study the women will be asked to fill in online questionnaires to assess the usability of the monitors. as the spouse is often a critical partner in the purchase decision and compliance, the investigators will also ask the spouse to complete similar online questionnaires.

Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation * females aged 18 to 44 years * have a body mass index (bmi) above 19 and below 29 * regular menstrual cycles, i.e. no greater than 7 days difference between the shortest and longest cycle in the last 6 months * minimum menstrual cycle 24 days * maximum menstrual cycle 33 days * female participants willing to use the 3 fertility monitors for at least 3 cycles. * willing to fill in regular questionnaires and study diaries exclusion criteria: * women aged younger than 18 years, or older than 44 years * have a bmi less than 18 or greater than 29 * any diagnosed systemic illnesses, including but not restricted to thyroid disease, diabetes or inflammatory diseases * polycystic ovary disease * endometriosis or other pelvic pathology (including proven tubal disease) * taking steroids, including oral contraceptives or anti inflammatory drugs
study of cp-751,871 in patients with ewing's sarcoma family of tumors

Conditions: Ewing's Sarcoma Family of Tumors

Summary: define the efficacy of cp-751,871 in patients with ewing's sarcoma family of tumors


Eligibility criteria:
inclusion criteria: * ewing's family of tumors * current disease state for which there is no curative therapy exclusion criteria: * prior anti-igf-1r therapy * concurrent treatment with other anti-cancer agents
studies in amyotrophic lateral sclerosis (als) and other neurodegenerative motor neuron disorders

Conditions: Amyotrophic Lateral Sclerosis

Summary: the purpose of this study is to collect, from patients with sporadic and familial als and their family members, clinical data and blood samples for extraction of dna, rna, preparation of lymphocytes, plasma and serum to establish a repository for future investigations of genetic contributions to als pathogenesis. blood samples for dna extraction also would be collected from control subjects with no personal or family history of als phenotypes.


Eligibility criteria:
inclusion criteria als or suspected als patient * clinical diagnosis of possible, laboratory-supported probable, probable or definite als according to modified el escorial criteria, suspected als according to original el escorial criteria, or diagnosis of a neurodegenerative disorder with evidence of als plus extramotor features; or * blood relative (first, second or third degree) with history of als or neurodegenerative disorder with evidence of als plus extramotor features; or: * a clinical suspicion or referral for als; * \> 18 years of age; * willing and able to give signed informed consent or assent that has been approved by the institutional review board (irb). blood relative of als patient * family history (first, second or third degree blood relative) of als or other motor neuron disease; * \> 18 years of age; * willing and able to give signed informed consent that has been approved by the institutional review board (irb). healthy control * no personal or family history (first, second or third degree blood relative) of als or other motor neuron disease; * \> 18 years of age; * no personal history of other neurodegenerative disease (i.e., alzheimer disease, parkinson disease); * willing and able to give signed informed consent that has been approved by the institutional review board (irb). exclusion criteria: als or suspected patient • limited mental capacity rendering the subject unable to provide written informed consent or assent or comply with standard phlebotomy procedures. blood relative of als patient • limited mental capacity rendering the subject unable to provide written informed consent or comply with standard phlebotomy procedures. healthy control subject * personal or family history of dementia or other neurodegenerative disease (parkinson disease, alzheimer disease, etc.); * limited mental capacity rendering the subject unable to provide written informed consent or comply with standard phlebotomy procedures.
evaluation of semi-rigid and flexible catheters for less invasive surfactant administration in preterm infants

Conditions: Neonatology; Perinatal Distress Syndrome

Summary: the overall aim of this study is to determine the differences between two surfactant administration catheters in preterm infants.

in this single-center, open-label, randomized-controlled trial, preterm infants requiring surfactant administration after birth, using a standardized minimal invasive protocol, were randomised to two different modes of endotracheal catheterization: flexible ch-4 feeding tube inserted using magill forceps (group 1) and semi-rigid catheter (group 2). primary outcome was duration of laryngoscopy. secondary outcomes were complication rate and vital parameters during laryngoscopy.

Eligibility criteria:
inclusion criteria: * preterm infants born less than 37 weeks of gestation * treating physician in charge of admission decides to administer intratracheal surfactant via standardized institution- lisa protocol (regardless of this study) (see supplement file 1) * written informed consent signed by caregivers or legal representative to participate exclusion criteria: * refusal to participate in study or not providing written informed consent by caregivers/parents * treating physician decides to use different route of surfactant administration or does not adhere to lisa protocol. * rupture of membranes (rom) at less than 22 weeks of gestation or more than 6 weeks before birth * estimated birth weight \< 3rd percentile using 2013 fenton growth trajectories * twins with feto-fetal transfusion syndrome (ffts) and ffts being the cause of premature delivery * contraindications listed in the lisacath® or nasogastric tube manual (esophageal/pharyngeal varices or other vascular lesions, esophageal/pharyngeal tumor, nasal fracture, skull fracture, known allergy to material)

Keywords: less invasive surfactant administration minimal invasive surfactant treatment preterm infant respiratory distress syndrome surfactant
egg intervention during pregnancy in indonesia

Conditions: Weight Gain; Anemia, Iron Deficiency; Birth Weight; Birth Length; Child Development; Zinc Deficiency; Folate Deficiency; B12 Deficiency Vitamin; Amino Acid Deficiency; Mineral Deficiency; Vitamin A Deficiency; Fatty Acid Deficiency; Parasite Infestation; E. Coli Infection; Salmonella Infections; Shigella Infection; Protozoan Infections

Summary: the study consists of two arms: 1) intervention group using eggs as supplementary food given from 2nd trimester of pregnancy to birth, and 2) observational group of pregnant mothers. it aims to assess the effectiveness of improving dietary quality during pregnancy on the epigenetic and stunting related outcomes (growth and development) in infants, who will be followed up until 24 months old

the study aims to assess the impact of improving dietary quality during pregnancy on the epigenetic and stunting related outcomes in infants. the open-label intervention study would be conducted alongside the observational study in the same study setting by recruitment of additional number (n=153) of pregnant women. thus, a total of 653 pregnant women would be enrolled in the study; 153 women would be randomized to intervention arm and 500 to the control arm who would form an observational cohort of women and newborns as described above. the intervention group women will be provided one egg three times per week from recruitment (2nd trimester) until term. the control group women will receive standard intervention in the form of ante natal care from village midwives or public health centre (ifa tablet, calcium tablet, nutrition counselling).

Eligibility criteria:
inclusion criteria: * woman is between 16 and 20 weeks of pregnancy based on the date of the first day of her last menstrual period. * she is 18-40 years of age. * she is planning to remain in the study area over the next 30 months. * she is of sasak ethnicity exclusion criteria: * she is expecting multiple births. * she has a known egg allergy.

Keywords: egg pregnancy indonesia epigenetic growth child development
rate of complete symptom relief, prevention of symptom relapse: grades a and b esophagitis of esomeprazole therapy

Conditions: Erosive Esophagitis

Summary: to investigate the impact of initial treatment duration (4-week versus 8-week)of esomeprazole (40mg) on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis

patients: patients between the ages of 15 and 80 years with clinical symptoms of acid regurgitation, heart burn, or feeling of acidity in the stomach, who have los angeles grade a and b erosive esophagitis proven by endoscopy are recruited. criteria for exclusions include (1) coexistence of peptic ulcer or gastrointestinal malignancies, (2) pregnancy, (3) coexistence of serious concomitant illness (for example, decompensated liver cirrhosis and uremia), (4) previous gastric surgery, (5) allergy to esomeprazole, (6) symptom score of a validated questionnaire (chinese gerdq) less than 12, and (7) equivocal endoscopic diagnosis of los angeles grade a and b erosive esophagitis. outcome parameters: the main outcome measures 1. rate of complete symptom relief (csr) at the end of initial treatment phase 2. rate of symptom relapse within 12 weeks after stopping initial therapy

Eligibility criteria:
inclusion criteria: * patients between the ages of 15 and 80 years * with clinical symptoms of acid regurgitation, heart burn, or feeling of acidity in the stomach, * who have los angeles grade a and b erosive esophagitis proven by endoscopy are recruited. exclusion criteria: 1. coexistence of peptic ulcer or gastrointestinal malignancies, 2. pregnancy, 3. coexistence of serious concomitant illness (for example, decompensated liver cirrhosis and uremia), 4. previous gastric surgery, 5. allergy to esomeprazole, 6. symptom score of a validated questionnaire (chinese gerdq) less than 12, and 7. equivocal endoscopic diagnosis of los angeles grade a and b erosive esophagitis.