Kornimate/medical-research-clean huggingface dataset:
increasing ureagenesis in inborn errors of metabolism with n-carbamylglutamate

Conditions: Urea Cycle Disorders, Inborn; Inborn Errors of Metabolism; Propionic Acidemia; Methylmalonic Acidemia; Carbamyl Phosphate Synthetase Deficiency

Summary: hyperammonemia, which can cause brain damage, occurs in many different kinds of inborn errors of metabolism. the investigators propose to determine if short-term (3 day) treatment with n-carbamylglutamate can diminish hyperammonemia by enhancing ureagenesis in these patients. the investigators propose here a short-term (3 day) trial. if it succeeds, the investigators would consider more extensive long-term studies of the drug.

* to determine whether brief (3 day) treatment with n-carbamylglutamate can improve ureagenesis in adult healthy controls and patients with the following inborn errors of metabolism: n-acetylglutamate synthetase deficiency, propionic acidemia, methylmalonic acidemia, carbamylphosphate synthase deficiency, ornithine transcarbamylase deficiency and the syndrome of hyperammonemia, hypoglycemia and hyperinsulinemia (hhh syndrome). * to determine if such treatment improves other indicators of abnormal nitrogen metabolism such as elevated blood levels of glutamine, glycine and alanine.

Eligibility criteria:
inclusion criteria: * age range: males or females, ages 3 years - 70 years * condition(s): n-acetylglutamate synthetase deficiency, propionic acidemia, methylmalonic acidemia, carbamylphosphate synthase deficiency, ornithine transcarbamylase deficiency and the syndrome of hyperammonemia, hypoglycemia and hyperinsulinemia. * in addition, healthy volunteers will be studied (ages 18 years - 50 years). exclusion criteria: * acutely ill on day of study (fever, evidence of hyperammonemia - ataxia, worsening obtundation, focal neurologic signs, seizures, increased intracranial pressure, vomiting, signs of acute respiratory or enteric illness, headache, confusion, disorientation, acute personality change). * girls 11 years of age must have a negative urine/serum pregnancy test within 1 week prior to testing unless having a menstrual period during week of test * lactating females * hyperammonemia probably refractory to n-carbamylglutamate: other urea cycle disorders (ucd), lysinuric protein intolerance, mitochondrial disorders, congenital lactic acidemia, fatty acid oxidation defects or primary liver disease. * amount of blood necessary for study exceeds safe limits. * any investigational drug use within 30 days prior to enrollment. * parents/guardians or subjects who, in the opinion of the pi, may be non-compliant with study schedules or procedures. * subjects who do not meet all the enrollment criteria may not be enrolled. any violations of these criteria will be reported in accordance with institutional review board (irb) policies and procedures.

Keywords: ureagenesis urea cycle inborn errors of metabolism
comparative trial in compression therapy in leg lymphedema

Conditions: Leg Lymphedema

Summary: the purpose of this trial is to study the effect of the 3m coban 2 layer compression system (hereafter c2l) in the treatment of leg lymphedema compared to the traditional treatment with trico bandages.

the goal of this prospective, randomized, controlled trial with ce marked product is to study the effectiveness (volume reduction) of 24-hour compression therapy for lymphedema, comparing c2l and trico bandaging. therefore 30 patients with leg lymphedema are included. application of marketed compression bandages (c2l or trico bandages) used for treatment by trained specialists with assessment of the subbandage pressure and volume reduction. measurements are carried out at: volumetry: measurements after 0h, 2h and 24 h by using classic water displacement apparatus. pressure: measurements after 0h, 2h (pre and post bandage change) and 24 h; * supine and standing to calculate the ssi; * supine with and without dorsal flexion. for the pressure measurement a kikuhime (large pads) dice is used. at each new bandaging to document the ssi and the effect of dorsiflexion in the supine position * the subbandage pressure is measured on the medial aspect of the lower leg at the transition of the gastrocnemius muscle into the achilles' tendon (b1) (partsch h. et al. dermatol surg 2006; 32: 224-233). * fix the sensor (sensor and tube sheathed with cellona soft padding) statistical analysis; analysis of variance (anova) comparing volume, supine subbandage pressure with and without dorsiflexion, and ssi for the used bandages

Eligibility criteria:
inclusion criteria: * gender: male or female * more than 18 years of age * patients with distal lymphedema of the leg requiring multilayer lymphedema bandaging of the leg * the patient is able to understand the study and is willing to give written informed consent to the study exclusion criteria: * allergy against one of the used materials * proximal lymphedema (involvement of thigh, genitalia) * severe systemic diseases causing peripheral oedema * acute superficial or deep vein thrombosis * arterial occlusive disease (stadium ii, iii or iv) or arm/leg blood pressure index (alpi)\<0,8 * local infection in the therapy area * auto-immunological disorders or vasculitis * use of systemic corticosteroids

Keywords: leg lymphedema volume measurement compression therapy interface pressure static stiffness index (ssi) volume change
a study of oral desmopressin in previously untreated children aged 5 to 15 years with primary nocturnal enuresis

Conditions: Nocturnal Enuresis

Summary: to evaluate the overall response to desmopressin treatment among previously untreated enuretic children aged 5-15 years after 3 and 6 months of treatment. to investigate the influence of possible predictive factors on response after 3 and 6 months of treatment. to evaluate the proportion of patients achieving dryness. to evaluate the long-term safety profile of oral desmopressin in children with primary nocturnal enuresis.

to evaluate the overall response to desmopressin treatment among previously untreated enuretic children aged 5-15 years after 3 and 6 months of treatment. to investigate the influence of possible predictive factors on response after 3 and 6 months of treatment. to evaluate the proportion of patients achieving dryness. to evaluate the long-term safety profile of oral desmopressin in children with primary nocturnal enuresis.

Eligibility criteria:
inclusion criteria: * children suffering from primary nocturnal enuresis with no organic pathology. * children of either sex, not below 5 and not above 15 years of age (not below 6 years in the netherlands and france). * children with a minimum of 6 wet nights in 2 weeks. exclusion criteria: * children who have previously been treated with desmopressin or other medications for nocturnal enuresis or enuresis alarms. * children receiving substances that are known or suspected to potentiate antidiuretic hormone, e.g. ssri, tricyclic antidepressant drugs, chlorpromazine and carbamazepine. * diagnosed renal diabetes insipidus or central diabetes insipidus with an avp (arginine vasopressin) deficiency. * proven urinary tract infection within the past month or a documented positive urine culture at the start of the study

Keywords: primary nocturnal enuresis
gene analysis in studying susceptibility to wilms tumor

Conditions: Recurrent Childhood Kidney Neoplasm; Stage I Kidney Wilms Tumor; Stage II Kidney Wilms Tumor; Stage III Kidney Wilms Tumor; Stage IV Kidney Wilms Tumor

Summary: this clinical trial studies gene analysis in studying susceptibility to wilms tumor. finding genetic markers for wilms tumor may help identify patients who are at risk of relapse.

primary objectives: i. to use a genome-wide association analysis to identify novel genetic variants that confer susceptibility to wilms tumor. ii. to improve our understanding of the genetic architecture and etiology of wilms tumor. iii. to facilitate the identification of genetic markers that are associated with an increased risk of developing of wilms tumor and/or those at risk of aggressive disease, relapse, additional tumors and/or cancer in their offspring. outline: samples are analyzed for single nucleotide polymorphism (snp) profiling using real-time polymerase chain reaction (pcr) and multiplex ligation-dependent probe amplification (mlpa).

Eligibility criteria:
inclusion criteria: * 3000 samples from the 1958 birth cohort (58c) and 3000 from the uk blood service control series (nbs)
safety and efficacy evaluation of iapa-dc/ctl combined gemcitabine therapy on advanced pancreatic cancer

Conditions: Carcinoma, Pancreatic Ductal

Summary: the aim of this study is to evaluate the safety and efficacy of iapa-dc/ctl combined gemcitabine therapy on advanced pancreatic cancer.


Eligibility criteria:
inclusion criteria: 1. advanced pancreatic cancer patients with histological pathology confirmation 2. both gender, aged 18-70 year-old 3. bone marrow functioned well 4. renal function normal 5. liver function normal 6. patients are voluntary, and willing to sign informed consent 7. expected lifetime was at least 3 months exclusion criteria: 1. with acute inflammation 2. accompanied with primary malignant tumor other than pancreas 3. with autoimmune disease 4. using corticosteroid or other suppress immune hormone treatment 5. had transplant operation of vital organs 6. active hepatitis 7. hiv positive 8. dysfunction in blood coagulation 9. serious diseases in circulatory and respiratory systems 10. pregnancy or breast-feeding women

Keywords: adoptive cellular immunotherapy patient safety therapeutic effect
oral baidi quzhi granule combined with ju ying cream for acne vulgaris

Conditions: Acne Vulgaris

Summary: we designed the study as a double-blind,randomized,controlled clinical trial.the aim of this trial is to clarify the treatment efficacy, safety, and recurrence control of baidi quzhi(bdqz) granule combined with ju yin(jy) cream in the treatment of acne vulgaris.

acne is a chronic inflammatory skin disease of hair follicle and sebaceous gland, which is common in adolescents and adults.systemic drugs commonly used in the treatment of acne include isotretinoin, oral antibiotics and hormone preparations. isotretinoin is the first choice for the treatment of moderate and severe acne, but its use is limited by its adverse reactions such as cheilitis, elevated blood lipids and teratogenicity .the efficacy of bdqz granule in the treatment of acne is accurate. however, large-scale randomized controlled trials have not been conducted on the efficacy, safety and recurrence of bdqz granule. therefore, our aim was to conduct a multicenter, randomized, double-blind, placebo-controlled clinical trial of oral bdqz granule combined with jy cream in the treatment of acne vulgaris.

Eligibility criteria:
inclusion criteria: - 1. patients with acne vulgaris aged from 16 to 45, male or female. 2. patients who meet the western diagnostic criteria of mild and moderate acne vulgaris and the differentiation criteria of tcm syndrome (15,16). 3. patients who voluntarily join this study with informed consent. 4. no acne drugs were received within 1 month, and no external drugs related to the disease were used within 1 week. exclusion criteria: * 1. patients with severe primary diseases such as cerebrovascular, cardiovascular, liver, kidney and hematopoietic system. 2. participants will be ineligible if they ate pregnant or lactating women, and those with fertility plans in the next 2 years. 3. patients who do not meet the inclusion criteria, fail to use the medicine according to the regulations, fail to judge the curative effect, or incomplete data affect the judgment of curative effect or safety. 4. allergic constitution and allergic to the drug ingredients studied in this project. 5. cicatricial constitution. 6.occupational acne caused by chemicals, acne caused by drugs.

Keywords: acne vulgaris randomized controlled trial baidi quzhi granule ju yin cream traditional chinese medicine
coronary artery disease and sleep apnea

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to determine the effect of sleep apnea on mortality, stroke and myocardial infarction among 408 patients with coronary artery disease referred for evaluation of coronary intervention who were examined with overnight cardio respiratory monitoring between march 1992 and june 1995.


Eligibility criteria:
inclusion criteria: * men and women younger than 70 with disabling angina pectoris and coronary disease according to coronary angiography.

Keywords: patients with coronary artery disease
odors to insufflate life

Conditions: Premature Newborns With Gestational Age 28 to 33 Weeks

Summary: apneas concern about 85% of premature newborns (nb) born after less than 34 weeks of pregnancy. they are considered as an important risk factor for subsequent neuropsychological deficiency. current pharmacological treatments are not very effective, and have side effects (agitation, irritability, sleep disorders, tachycardia). some studies suggest that in nbs with apneas resisting to drugs, a permanent odorisation with a drop of vanillin on the incubator's pillow might reduce the frequency of apneas. this latin square design study will test a controlled olfactory stimulation method, i.e. an olfactometer which controls the odor duration, intensity, and sequence using three different odors, to reduce apneic episodes measured using 24-registration of heart and respiratory rates.


Eligibility criteria:
inclusion criteria: * newborns from a single or multiple pregnancy * newborns hospitalized in the lyon east or saint-etienne neonatology services, of both sexes, born before 33 weeks of amenorrhea and after at least 6 days of life, without respiratory disease beside premature birth. * newborns must present at least 3 bradycardia during 3 days, or presenting apneas at observation. * newborns will be randomized if they present at least 3 apnea episodes per 24 hour monitored by recan for 3 consecutive days prior to randomization. * written informed consents obtained from the newborns parents or legal representatives exclusion criteria: * severe congenital malformation * history of allergic reaction to smell stimulation (cough, sneeze, watery eyes, breathing pauses) * no social insurance

Keywords: premature newborns apneas prevention olfactory stimulation latin square design
treatment, emotion, and neuromodulation of depression (trend) study

Conditions: Depression

Summary: the investigators will administer theta burst stimulation (tbs) in efforts to observe a decrease in severity of reported depression symptoms. a subset of participants will receive positive affect training during this intervention.

the study has a longitudinal design in which participants complete a baseline assessment, 20 theta burst stimulation (tbs) sessions, a post-tbs assessment, and a follow-up assessment 4 months later. ideally, tbs sessions will be delivered twice/day, 5 days/week, for 2 weeks. this procedural design of a shorter treatment duration is based on findings of pattern of improvement and newly developed saint protocol. a subset of participants will receive training in enhancing positive affect, with 10 training sessions occurring between pairs of tbs sessions. in this study, "response" to intervention will be defined as a greater than 50% decrease in severity of depression symptoms reported by participants.

Eligibility criteria:
inclusion criteria: * current diagnostic and statistical manual (dsm-5) depressive disorder exclusion criteria: * bipolar disorder (lifetime) * obsessive-compulsive disorder (lifetime) * history of psychosis * daily use of nicotine * past-month use of cocaine, amphetamines, methyl enedioxy methamphetamine (mdma), phencyclidine (pcp), ketamine, or gamma-hydroxybutyrate (ghb) * past 6 month substance use disorder * binge drinking (using niaaa criteria) within the past week, alcohol use in the past 12 hours * neurological disorders: epilepsy, parkinson's disease, brain tumor, brain injury, stroke * history of head trauma with a loss of consciousness (e.g., concussion) * history of seizures * mri contraindications: body shape/size too large to fit in scanner, claustrophobia, and ferromagnetic metal in the body * pregnancy * current use of clozapine, bupropion, or prescription stimulants * current use of benzodiazepines or mood stabilizers * body shape/size too large to fit in mri scanner * claustrophobia * metal in the head or ferromagnetic metal in the rest of the body * implanted medical devices * high-risk suicidality

Keywords: positive affect theta burst stimulation
the effect of kangaroo care method on the self-confıdence and attachment levels of fathers of preterm babies

Conditions: Attachment Disorder

Summary: this study was conducted as a randomized controlled experimental type to evaluate the confidence and attachment levels of fathers in baby care whose babies were treated in the neonatal intensive care unit.


Eligibility criteria:
inclusion criteria: for newborns: * being a newborn treated in the istanbul başakşehir çam and sakura hospital neonatal intensive care unit * gestational age less than 37 weeks * postnatal age between 0-28 days * the baby is considered stable by a neonatologist * the baby can maintain body temperature during kangaroo care * safety is ensured if there is an existing umbilical or central catheter for fathers: * agreeing to practice kangaroo care * having no health condition that would prevent practicing kangaroo care * being able to maintain sufficient hygiene conditions for kangaroo care * being literate * being able to communicate in turkish exclusion criteria: for babies: * receiving respiratory support * having a chest tube * having a congenital anomaly * using sedative medication * having undergone surgery for fathers: * not wanting to practice kangaroo care * using substances that cause sedation (drugs, alcohol) * having a disease that can be transmitted through skin contact * not agreeing to participate in the study * not living in the same house as the baby
dose dense carboplatin, taxotere and herceptin as primary systemic therapy in breast cancer

Conditions: Breast Cancer

Summary: dose dense therapy has been shown to increase survival in the adjuvant setting of breast cancer. it is unknown if dose dense therapy will improve survival in tumors that express her-2. this study evaluates a neoadjuvant regimen containing carboplatin, taxotere and herceptin when used in a dose dense manner in patients with large breast cancers. the endpoint of pathologic complete response is used as a surrogate marker for survival.

dose dense therapy has been shown to increase survival in the adjuvant setting of breast cancer. it is unknown if dose dense therapy will improve survival in tumors that express her-2. this study evaluates a neoadjuvant regimen containing carboplatin, taxotere and herceptin when used in a dose dense manner in patients with large breast cancers. the endpoint of pathologic complete response is used as a surrogate marker for survival.safety and tolerability assessed by number of grade 4 toxicities and hospitalizations

Eligibility criteria:
inclusion criteria: * her-2 overexpressing breast cancer * clinical stage 2-3b * normal ejection fraction exclusion criteria: * metastatic disease * low ejection fraction
the impact of interpretation bias modification training on anger and reactive aggression

Conditions: Anger

Summary: difficulties with anger control are reported in a number of psychological conditions and are associated with social problems, such as dating violence and workplace violence. high trait anger is a personality construct characterized by elevations in the frequency, duration, and intensity of anger episodes. however, the cognitive processes contributing to high trait anger are still poorly understood. this study will examine the effectiveness of a computer-based cognitive bias modification (cbm) program designed to target hostile interpretations associated with high trait anger.

high trait anger is a personality construct characterized by elevations in the frequency, duration, and intensity of anger episodes. according to the integrative cognitive model (icm) of anger, three cognitive processes jointly contribute to an individual's level of trait anger and reactive aggression: hostile attributions, ruminative attention, and effortful control processes. specifically, individuals high in trait anger are more prone to interpret ambiguous situations as hostile; are more likely to ruminate about anger-related events; and have a more limited capacity to employ control processes when they become angry. one means of evaluating unconscious biases that has become increasingly popular is cognitive bias modification (cbm). cbm programs are computerized training paradigms, which aim to train more adaptive cognitive biases by repeatedly exposing participants to an experimental contingency between an emotional stimulus and a response.previous researchers have begun to investigate the impact of cbms targeting cognitive control and hostile attribution bias in relation to anger. however, these studies have been conducted exclusively in samples reporting low trait anger. this study will examine the effectiveness of a short-term interpretation bias modification program (cbm-i) on hostile attribution biases and reactive aggression in a sample of undergraduate students eporting high trait anger.

Eligibility criteria:
inclusion criteria: 1. students scoring 22 or higher on the trait anger scale. exclusion criteria: 1. reports currently receiving psychological treatment or counseling for anger. 2. reports changes in psychiatric medication within the last month. 3. endorsement of current psychosis or bipolar disorder symptoms. 4. indicates poor english language proficiency.

Keywords: reactive aggression high trait anger cognitive bias modification interpretation bias modification