Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the safety, tolerability, and pharmacokinetics of ro7303509 in participants with systemic sclerosis

Conditions: Systemic Sclerosis

Summary: the purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (pk) of ro7303509 treatment in participants with systemic sclerosis (ssc) during a multiple-ascending-dose (mad) portion of the trial. in the mad phase, increasing doses of study drug will be tested sequentially. for each dose tested, the mad stage will consist of a treatment period of 12 weeks followed by either a safety follow-up period of 13 weeks or continued treatment in an optional open-label safety extension (ose) stage of 52 weeks to assess the long-term safety. all patients in the ose stage will receive ro7303509 and no patient will receive placebo.


Eligibility criteria:
inclusion criteria: inclusion criteria for the mad stage: * weight of 45-150 kg at screening * diagnosis of ssc, as defined by 2013 american college of rheumatology (acr)/european league against rheumatism (eular) criteria and ≤ 10 years disease duration from first non-raynaud's symptom * agreement to remain abstinent or use an effective contraceptive method among males and females with childbearing potential for 4 months after last dose of study drug inclusion criteria for the ose stage: * no clinically significant change in eligibility status * completion of the mad and ability to roll over into the ose within 5 days exclusion criteria: * active rheumatic autoimmune disease other than ssc requiring treatment with disease-modifying therapy * pulmonary disease with forced vital capacity (fvc) ≤ 50% of predicted * history or clinical manifestations of significant metabolic, hepatic, renal, pulmonary, cardiovascular, hematologic, gastrointestinal, urologic, neurologic, or psychiatric disorders * history of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies * pregnant or breastfeeding, or intending to become pregnant during the study or within 4 months after the final dose of study drug * major surgery within 8 weeks prior to screening, or major planned surgery during the study or within 3 months after the final dose * positive hepatitis c virus (hcv) antibody, hepatitis b surface antigen (hbsag), or human immunodeficiency virus (hiv) antibody test at screening * any serious medical condition or abnormality in clinical laboratory tests
magnesium therapy in children with cerebral palsy

Conditions: Cerebral Palsy

Summary: this study is considered a pilot exploratory study. intervention, prospective, double-armed, randomized, placebo-control clinical trial. the therapeutic effect of oral magnesium sulfate on spasticity and constipation will be studied.

spasticity and constipation are major problems hindering improvement in motor development in children with cerebral palsy. decreasing spasticity will have a positive effect on motor development and quality of life for the child and his family. the aim is to study the therapeutic and adverse effects of oral magnesium sulfate therapy on spasticity and constipation in infants and children with cerebral palsy. hundred children with spastic cerebral palsy will be randomized to either intervention group n=50 will be treated with magnesium sulfate 4% orally for 28 days to treat spasticity and constipation in addition to their conventional treatment, or placebo group n=50 will receive conventional treatment and placebo.

Eligibility criteria:
inclusion criteria: * age below12 years. * presence of spasticity without joint contracture spasticity is defined as velocity dependent, increased resistance to passive muscle stretch. * acceptance of caregivers to participate in the study and signing the written consent. * constipation will be defined according to rome lll criteria.presence of at least 2 of the following 2 motions week, history of painful or hard bowel movement, presence of large diameter stools that stools that may obstruct the toilets (burgers et al., 2012). exclusion criteria: * severe growth retardation (below the 10th centile for weight and length charts children with cerebral palsy). * gastrostomy tube feeding. * joint contractures. * congenital malformations. * suspected inborn error of metabolism. * suspected inherited neurologic disease. * care giver's refusal to participate in the study. * occurrence of side effects of oral magnesium sulfate. * patients with cardiac, renal, git problem or chronic diarrhea.

Keywords: child
economic analysis of alliance a041202 cll study

Conditions: Chronic Lymphocytic Leukemia

Summary: the prospective cost-effectiveness (cost-utility) analysis from the perspective of the canadian public healthcare system was completed in 2021. health state utilities were collected using the euroqol eq-5d instrument with canadian tarrifs applied to calculate quality-adjusted life-years (qalys). costs were applied to resource utilization data (expressed in 20196 us dollars). we examined costs and outcomes (qalys) associated with ibrutinib with rituximab (ir) and br therapy.


Eligibility criteria:
inclusion criteria: * patient must be eligible for the core clc.2/a041202 protocol. * patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate. * patient must be able (i.e. sufficiently fluent), and willing to complete the health utilities questionnaire in english or french. the baseline assessment must be completed within required timelines, prior to registration/randomization inability (illiteracy in english or french, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the core protocol. however, ability but unwillingness to complete the questionnaires will make the patient ineligible for the core protocol. * patients must be accessible for treatment and follow-up. investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up. exclusion criteria: * none
wired mothers - use of mobile phones to improve maternal and neonatal health in zanzibar

Conditions: Pregnancy; Maternal Health; Newborn Death; Health Behavior; mHealth

Summary: reducing maternal and newborn mortality remains a global challenge. because obstetric complications cannot be predicted, skilled attendance at the time of delivery and access to emergency obstetric care remain the most effective strategies to reduce mortality. antenatal care has the potential to reduce maternal morbidity and improve newborns survival but this benefit may not be realized in sub-saharan africa where the attendance and quality of care is declining. there is a rapidly expanding number of mobile phone users in developing countries and due to the potential to strengthen health system the use of mobile phones is health care is emerging. the investigators assessed a mobile phone intervention named "wired mothers" aimed to improve maternal and newborn health. the hypothesis of the study was that the wired mothers mobile phone intervention would increase attendance to essential reproductive health services such as antenatal care and skilled delivery attendance and reduce severe adverse pregnancy outcomes for women and newborn. the objective of the study was to examine the effect of the wired mothers intervention on antenatal care, skilled delivery attendance, access to emergency obstetric care and perinatal mortality. the study was a pragmatic cluster randomized controlled trial with the primary health care facility as the unit of randomization. the study took place in 2009-2010 on the island of unguja in zanzibar. 2550 pregnant women who attended antenatal care at one of 24 selected facilities were included at their first visit and followed until 42 days after delivery. facilities were allocated by simple randomization to either mobile phone intervention (n=12) or standard care (n=12). the intervention consisted of a sms and mobile phone voucher component. the perspectives of the study are that mobile phones may contribute to saving the lives of women and their newborns and achievement of mdgs 4 and 5. evidence is needed to guide maternal and child health policy makers in developing countries.


Eligibility criteria:
inclusion criteria: * pregnant women attending antenatal care at one of 24 selected primary healthcare facilities exclusion criteria: * missing end-of-study questionnaire

Keywords: maternal health neonatal health mhealth mobile phones access to health services health behavior
micronutrient status during pregnancy

Conditions: Deficiency Vitamins

Summary: an adequate micronutrient status during fetal life and infancy is important for optimal development. dietary practices during pregnancy, lactation and infancy vary among populations and there is today no clear agreement on what constitutes the best diet, including micronutrient supplementation, during this period. there is consequently no clear agreement on what constitutes an optimal biochemical micronutrient status in mothers and infants. due to substantial physiological changes in plasma volume, hormones, transport proteins and organ function during these periods, the ordinary reference levels or cut off levels used for biochemical assessment of micronutrient status are unsuited to these groups of patients. the objective of the study is to establish cut off levels for important vitamins and trace elements during pregnancy, lactation and infancy in order to ensure an optimal infant neurodevelopment and to study how micronutrient status influence the immunosystem.

the investigators have analyzed micronutrients, including all vitamins and trace elements and related aminoacids and markers of cellular immunoactivation in 160 fertile, unpregnant women, 115 pregnant women from pregnancy week 18, throughout pregnancy and the first 6 postpartum months and their infant at 6 months. infant gross motor development is associated with micronutrient status, so the investigators will relate gross motor development at 6 months to maternal micronutrient status during pregnancy and postpartum, in order to establish relevant cut off levels for micronutrients and related biomarkers.

Eligibility criteria:
inclusion criteria: * healthy never-pregnant and pregnant women exclusion criteria: chronic illness-

Keywords: cobalamin, folate
the effect of hyperbaric oxygen therapy on breast cancer patients with late radiation toxicity - umbrella honey trial

Conditions: Breast Cancer; Radiation Toxicity

Summary: the "hyperbaric oxygen therapy on breast cancer patients with late radiation toxicity" (honey) trial aims to evaluate the effectiveness of hbot on late radiation toxicity in breast cancer patients using the trial within cohorts (twics) design.

objective: the aim of this study is to assess whether hbot reduces pain, and improves physical functioning and qol in breast cancer patients with late radiation toxicity. study design: randomized controlled trial, nested within the prospective umbrella breast cancer cohort according to the twic's design. umbrella is a prospective cohort study including all breast cancer patients visiting the university medical center (umc) utrecht department of radiotherapy. in total 120 patients will be randomized in a ratio of 2:1. study population: breast cancer patients participating in the umbrella cohort who have given informed consent to be invited for future research (e.g. cmrct's), and who have reported symptoms of late radiation toxicity. intervention: eligible patients will be referred to the hbo center for a standard hbo treatment. hbot consists of 30-40 treatment sessions (1 session per day during 5 days per week). during the hyperbaric oxygen (hbo) sessions patients breath in 100% oxygen during 4 times 20 minutes in a hyperbaric chamber. main study parameters/endpoints: the primary endpoint of this study is patient reported breast/chest wall pain. secondary endpoints are: physical functioning, qol cosmetic outcome, physician reported pain and radiation toxicity (according to ctcae criteria version 4.03, tissue oxygenation previous to hbot and after hbot and side-effects of hbot.

Eligibility criteria:
inclusion criteria: * self reported pain grade 3-4 (on a scale of 1-4) as assessed by the late radiation toxicity questionnaire; * participation \>12 months in the umbrella cohort; * previous treatment with radiotherapy for breast cancer; * completed surgery and (neo)adjuvant systemic therapy except adjuvant endocrine therapy, for breast cancer. exclusion criteria: * poor responder to questionnaires (i.e. return of ≤ 2 umbrella questionnaires); * previous hbot; * contra-indications for hbot (e.g. (severe) chronic obstructive pulmonary disease (copd) or asthma, pacemaker, morbid obesity, epilepsy in medical history, severe heart failure); * current metastatic disease or recurrent breast cancer. additional exclusions criteria based on screening visit: * inability to follow schedule of all consecutive hbo treatments (e.g. due to scheduled holidays \> 2 days); * not meeting criteria for hbot (e.g. due to complaints similar to late radiation toxicity, not caused by radiotherapy).

Keywords: breast cancer radiotherapy hyperbaric oxygen therapy late toxicity trials within cohorts patient reported outcomes
l-carnitine vs placebo for the treatment of muscle cramps after imatinib in gastrointestinal stromal tumors

Conditions: Gastrointestinal Stromal Tumors (GISTs)

Summary: we aim to evaluate the efficacy of l-carnitine for the treatment of muscle cramps after imatinib in patients with gist and apply in the future.

one of the most common side effects of imatinib treatment, muscle cramps occur in about 30% of patients with gastrointestinal stromal tumor (gist) receiving treatment with imatinib. it affects the quality of life (qol) of patients and could also be a factor that affects compliance with treatment. some studies suggest that l-carnitine may improve muscle cramps associated with cirrhosis or hemodialysis. however, the efficacy of l-carnitine for muscle cramps occurring after imatinib treatment has yet to be reported. thus, we aim to evaluate the efficacy of l-carnitine for the treatment of muscle cramps after imatinib in patients with gist and apply in the future.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed gist patients who are taking imatinib 2. age 18years or older 3. patients experienced muscle cramps for more than 8 times (pain of nrs \> 4) or 4 times (pain of nrs \>7) within last 4 weeks 4. life expectancy \> 6 months 5. ecog performance status of 0-3 exclusion criteria: 1. patients with renal disease receiving hemodialysis 2. liver cirrhosis patients with child-pugh class b or c 3. patients with history of hypersensitivity to drugs including l-carnitine or nutritional supplements 4. patients with history of spinal cord injury, peripheral vascular disease, or \> grade 2 peripheral sensory neuropathy 5. patients with clinically significant electrolyte imbalances such as hypocalcemia, hypokalemia, and hypomagnesaemia
evaluation of safety and efficacy of using lipsus device for oral wetting

Conditions: Oral Dryness; General Surgery

Summary: following waking up from surgery performed under general anesthesia, patients are suffering from discomforting oral dryness, and moreover, they are not allowed drinking for 24 hours. the current management involves the wetting of patient's lips using wet bandage. this action is dependent on the presence of a family member or a nurse, which is not always possible. many patients describe the oral dryness as a suffering, added to the suffering anyway entailed by surgery. the investigated lipsus device is intended for oral wetting, relieving patient's suffering and minimizing the dependence on continuous presence next to patient's bed.


Eligibility criteria:
inclusion criteria: * subject is scheduled for surgery under general anesthesia. * male/female age 18 and up. * subject able to comprehend and give informed consent for participation in this study * subject must sign the informed consent form. exclusion criteria: * subjects who have any form of suspicious lesion in treatment target area. * pregnant or lactating subjects * subjects with any infection / abscess / bleeding / blister / crack / edema / fissure / ulcer / pain in treatment target area. * eczema or dermatitis in treatment target area * subjects on drugs or psychologically determined unsuitable for the study. * subject is suffering extreme general weakness. * subject objects to the study protocol. * concurrent participation in any other clinical study * physician objection

Keywords: general surgery
a study of an alternative treatment approach (preoperative radiotherapy, then mastectomy, then immediate reconstruction surgery) in people with t4 breast cancer

Conditions: Breast Cancer; Invasive Breast Cancer

Summary: the purpose of this study to test an alternative treatment approach that involves giving participants radiotherapy before their mastectomy (preoperative radiotherapy) and performing immediate reconstruction surgery at the time of mastectomy. the immediate reconstruction surgery is called an immediate autologous reconstruction (ir) and is different than the standard reconstruction surgery people with t4 breast cancer have. ir is a surgical procedure where immediately following your mastectomy, the surgeon takes tissue from another part of your body and uses it to re-create your breast. the standard reconstruction surgery occurs later and can be done with an implant or tissue from your body. the main purpose of this study to find out if the alternative treatment approach shown above is feasible. the study will see how safe this alternative treatment approach is compared with the standard treatment approach.


Eligibility criteria:
inclusion criteria: * female sex, aged ≥18 years, with biopsy-proven invasive breast cancer * ct3-4 cn0-3 tumor * partial or complete response to nac on imaging and clinical examination using the response evaluation criteria in solid tumors (recistv1.1) definition. * desire to undergo autologous reconstruction and assessed to be an appropriate candidate by a plastic and reconstructive surgeon * able to read and understand english exclusion criteria: * prior ipsilateral breast cancer * bilateral breast cancer * pregnant * stage iv disease at presentation * stable disease or progressive disease after nac * surgically unresectable breast disease * bmi \>40 * prior history of thoracic radiotherapy

Keywords: breast cancer mastectomy memorial sloan kettering cancer center 22-136
effects of lubiprostone on gastric function in patients with chronic idiopathic constipation

Conditions: Chronic Idiopathic Constipation

Summary: this prospective study is designed to evaluate how lubiprostone may affect gastric motor and sensory function.


Eligibility criteria:
inclusion criteria: * chronic idiopathic constipation exclusion criteria: * medications that slow gastrointestinal (gi) motility * prior surgery to the gi tract

Keywords: constipation chronic idiopathic constipation no prior history of surgery to the colon not on any type of medication that could alter gastrointestinal motility or transit
norepinephrine versus ephedrin for prevention of post spinal anesthesia in cesarean section

Conditions: Maternal Hypotension Syndrome; Cesarean

Summary: spinal anesthesia is still the gold standard anesthetic method for elective and urgent cesarean section, the post spinal hypotension remains the most frequent complication of this procedure and is still responsible of considerable maternel and fetal morbidity. it is recommanded to prevent this post spinal hypotension with fluid coloading and prophylactic vasopressors administration. the aim of this study is to compare the efficency and the safety of norepinephrin and ephedrin prophylactic administration to reduce the incidence of post spinal hypotension in cesarean section.

spinal anesthesia is still the gold standard anesthetic method for elective and urgent cesarean section, the post spinal hypotension remains the most frequent complication of this procedure and is still responsible of considerable maternel and fetal morbidity. it is recommanded to prevent this post spinal hypotension with fluid coloading and prophylactic vasopressors administration. the prophylactic use of norepinephrin and phenylephrin has been validated by several studies, but few data are published concerning the comparaison between norepinephrin and ephedrine as preventive vasopressors in cesarean section; these molecules act on alpha and beta adrenergic receptors and could provide better maternal hemodynamics in parturients undergoing cesarean section under spinal anesthesia. the aim of this study is to compare the efficency and the safety of norepinephrin and ephedrin prophylactic administration to reduce the incidence of post spinal hypotension in cesarean section.

Eligibility criteria:
inclusion criteria: * full termed parturients scheduled for elective or semi urgent cesarean section under spinal anesthesia * age\>15 years * asa ii status * no history of hypertension, preeclampsia or cardiopathy * bmi\<40 exclusion criteria: * cesarean section under genearl anesthesia or epidural analgesia during labor
efficacy, safety and tolerability of a novel ocular antiseptic for ocular use (clean)

Conditions: Diabetic Macular Edema; Branch Retinal Vein Occlusion; Glaucoma/Closed Angle Glaucoma

Summary: this is a randomized, double-masked, multicenter, study to evaluate the efficacy, safety, and tolerability of irx-101 versus 5% povidone-iodine (pi) in subjects receiving intravitreal anti-vegf injections. the study will be conducted in up to 30 centers in the united states (us).

intravitreal injection therapy (ivt) of anti-vascular endothelial growth factor (vegf) agents has transformed the treatment landscape of several retinal diseases, including exudative (wet) macular degeneration, retinal vein occlusion, diabetic macular edema, and choroidal neovascularization. the most common adverse effects of ivt occur due to the side effects of povidone-iodine 5% (pi; brand name: betadine® 5%; alcon, fort worth, tx), the antiseptic placed on the ocular surface prior to each injection. pi is nearly universally used to prevent ocular infection (endophthalmitis). pi leads to marked corneal epithelial toxicity in humans,6, 7 resulting in debilitating side effects including decreased visual acuity and pain that can last more than 3 days post-ivt. post-ivt pain is severe enough to require oral analgesics in up to 30% of patients and is a frequent cause of treatment discontinuation. therefore, there is an unmet need in ophthalmology for a potent ocular antiseptic with a superior safety profile.

Eligibility criteria:
inclusion criteria: 1. capable of giving informed consent 2. stated willingness to comply with all study procedures and availability for the duration of the study 3. male or female, ≥ 18 years of age and receiving intravitreal anti-vegf injections in one or both eyes exclusion criteria: 1. current or past diagnosis of endophthalmitis 2. current diagnosis of uveitis 3. current use of viscous lidocaine products for ocular anesthesia prior to ivt 4. currently receiving intravitreal steroid injections 5. concurrent participation in another clinical trial