Kornimate/medical-research-clean huggingface dataset:
treatment for alcoholism and post-traumatic stress disorder (naltrexone)

Conditions: Alcoholism; Alcohol Dependence; Post-Traumatic Stress Disorder

Summary: this study will evaluate naltrexone and cognitive-behavioral therapy treatments for alcohol dependence and post-traumatic stress disorder (ptsd). subjects will be randomly assigned a 6-month treatment of either: 1) naltrexone alone, 2) naltrexone with ptsd psychosocial therapy, 3) a placebo with ptsd psychosocial therapy, or 4) placebo alone. an enhanced medication management intervention will accompany all treatment conditions. follow-up assessments will be completed at 9 and 12 months after treatment.


Eligibility criteria:
inclusion criteria: * meets criteria for alcohol dependence and post-traumatic stress disorder. * heavy drinking in the past 30 days (an average of more than 12 alcohol drinks per week with at least 1 day of 4 or more drinks). * successfully complete medical detoxification. * exhibit clinically significant trauma-related symptoms. * live in a commutable distance to the university of pennsylvania and agree to follow-up visits. * aged between 18 and 65 years old. * able to provide an informed consent. * speak and read english. exclusion criteria: * current diagnosis of any substance dependence other than alcohol, nicotine, or cannabis. * evidence of opiate use in the past 30 days. * significant risk of violence or history of serious violent behavior during the past year. * continued contact with an intimate partner if assault by the partner is the index trauma. * changes in dosage or medication for any ssri treatment in the three months prior to entering the study. * unstable or serious medical illness. * current severe psychiatric symptom. * mental retardation or another pervasive developmental disorder. * use of an investigational medication in the past 30 days. * pregnant, nursing or not using reliable contraception.

Keywords: alcoholism alcohol dependence post-traumatic stress disorder naltrexone cognitive behavior therapy
safety study of an intravenous staphylococcus aureus immune globulin (human), [altastaph] in low-birth-weight-neonates

Conditions: Staphylococcal Infections

Summary: the main objective will be to test the safety of two intravenous infusions of altastaph, a human immunoglobulin product. the study will also test the ability of altastaph to protect against s. aureus infection.

survival of very-low-birth-weight (vlbw) infants (\<1500g at birth) has improved dramatically, but these patients remain subject to significant morbidity and mortality due to staphylococcus aureus infection. s. aureus infection is a relatively common event in vlbw neonates, occurring in approximately 3.4% of very low birth weight neonates and accounting for 15-20% of all infections in this patient population. this controlled study will assess the safety, pharmacokinetics, and preliminary efficacy of altastaph in lbw neonates. the study will be stratified by birth weight and include up to 200 lbw neonates, 3 to 7 days of age.

Eligibility criteria:
the subject must conform to all of the following (inclusion criteria): * neonate with a birth weight between 501 and 1500 grams inclusive; * between 3 and 7 days of age, inclusive, at the time of first infusion (day 0); * expected to survive at least 48 hours after infusion; * free of overt systemic infection, as determined by history, physical examination, radiologic studies, or laboratory studies including microbiology data; clinical safety tests required can be completed up to three (3) days prior to the infusion of the study product; * direct bilirubin less than or equal to 2.0 mg/dl; * serum creatinine level of less than or equal to 2.0 mg/dl; and * hemodynamically stabile; if the subject is receiving cardiac support including anti-arrhythmics, pressors, or cardiac pacing, the subject must be stable on that cardiac support and be expected not to require this support indefinitely. the subject must not have any of the following (exclusion criteria): * known hiv infection, as documented by maternal history or positive pcr in the infant; * severe congenital anomaly or genetic disorder known to impact immune competence; * prior administration of any immune globulin; * any history, in the infant subject or its mother, of hypersensitivity or severe vasomotor reaction to any human blood product; * cyanotic congenital heart disease; and * central nervous system shunt

Keywords: staphylococcal infection gram positive bacteria staphylococcus staphylococcus aureus
post-market clinical follow-up (pmcf) study of the poly-tape device for medial patellofemoral ligament (mpfl) reconstruction

Conditions: Medial Patellofemoral Dislocation

Summary: this is a post market clinical follow up study in orthopaedics. it will verify the long-term safety and performance of the device in the intended patient population, when indicated for the reconstruction of a ligament in the kneecap - the medial patellofemoral ligament (mpfl). the medical device in this study, poly-tape, is a class iib ce-marked device manufactured by xiros ltd. poly-tapes are a single-use device, they are indicated for patients repair of soft tissue and/or reconstruction of ligaments, tendons, and other soft tissues. the device can be fixed to the bone using several different methods including screws. this study is a prospective, multicentre, consecutively recruited non-randomised study. the total length of the study is expected to be 7 years. this includes a recruitment period of approximately 24 months and a 5-year follow-up. a total of 55 subjects will be enrolled into the study with follow up at 6 months, 1 year, 2 years and 5 years in clinic and by questionnaires. all subjects treated with the poly-tape for mpfl reconstruction, will be consecutively recruited into the study.


Eligibility criteria:
inclusion criteria: patient must be 13 years old or above. patients who require mpfl reconstruction. patients willing to participate in the study and have been informed of the nature of the study, agree to its follow-up and have provided written informed consent as approved by the research ethics committee (rec). exclusion criteria: these devices should not be used in procedures which bridge, disturb, or disrupt the growth plate in immature patients since they will not elongate as the patient grows. patients known to be hypersensitive to titanium alloy or polyester. appropriate tests should be carried out on patients with suspected material sensitivity prior to implantation. patients with any infections or structural or pathological condition of the bone or soft tissue that would be expected to impair healing or secure fixation. bone quality should be assessed prior to surgery. patients who are unable or unwilling to restrict activities to prescribed levels or to follow the rehabilitation instructions during the healing period. patients for whom the implantation is intended to be non-permanent, since they integrate well with the patient's tissue.
an open phase 3 study of iv-globulin sn inj.10% to treat immune thrombocytopenia

Conditions: Immune Thrombocytopenia

Summary: human immunoglobulin (ig) is the most commonly used blood product. it has been well-defined the efficacy in patients with immunodeficiencies, kawasaki disease, asthma and other immune diseases. it is expected that ig 10% will improve the usefulness and safety profile compared to ig 5% because it is expected the reduced hospitalization/treatment duration and less adverse events related to volume overload.

gc5107a (iv-globulin sn inj. 10%) is a polyvalent intravenous human immunoglobulin g preparation. it is prepared from plasma collected from more than 1000 healthy blood donors and it expresses the large spectrum of antibody specificity.

Eligibility criteria:
inclusion criteria: * given written informed consent * male or female aged ≥ 19 * primary immune thrombocytopenia (itp) * platelet \<20x10\^9 /l * patients who have taken adrenal cortical hormones and/or other immunosuppressive medications should maintain their stable doses before and during this study exclusion criteria: * patients who have participate in other interventional study within 30 days * inability in written/verbal communication * engaged with an elective surgery * pregnant or breast-feeding women * women of childbearing potential who do not agree with contraception during this study * patients who had experienced any hypersensitivity or shock with study drug or active ingredient * refractory to immunoglobulin therapy * secondary immune thrombocytopenia * hiv-associated itp * lupus-associated itp * lymphproliferative disease * hepatitis virus carrier * other disease- or infection-associated itp * drug-induced itp * hereditary thrombopenia (e.g., myh9 disorders) * hemolytic anemia (positive direct coomb's test) * clinically significant abnormalities of immunoglobulin * immunoglobulin a deficiency * immune disorders or deficiency * alcohol or drug abuse within 6 months * patients who had taken any medications which may effect platelet function or count for at least 2 days prior study entry * patients who had administrated with ivig or anti-d immunoglobulin agents within 1 month * patients who had undergone a splenectomy within 2 months * clinically significant underlying disease or medical history at investigator's discretion

Keywords: immune thrombocytopenia immune thrombocytopenic purpura idiopathic thrombocytopenic purpura human immunoglobulin itp ivig igiv iv-globulin sn inj.
analgesic efficacy of intranasal desmopressin in acute renal colic

Conditions: Renal Colic; Pain

Summary: in this study we will compare pain intensity and side effects at different time points after the intranasal administration of desmopressin or placebo in patients with acute renal colic pain.

obstruction of the urinary tract can increase pelvi-ureteric pressure and thus cause renal colic pain, which can be very severe. conventional therapy consists of non-steroidal anti-inflammatory drugs (nsaids) and opioids. nsaids have many side effects and opioids are not always available. in addition, the intravenous form of nsaids is not routinely available in iran, and the drug is mainly used in the form of suppository. due to these reasons, research on newer replacement therapies with fewer side effects is necessary. desmopressin intranasal spray has already been shown to be partially effective in renal colic pain in a few studies. due to its lower side effects, we decided to conduct a clinical trial with desmopressin to evaluate pain relief in renal colic. in this study, eighty-eight patients with acute renal colic pain, referring to imam khomeini hospital in tehran, will be randomly allocated to receive either intranasal desmopressin or placebo. both groups will also receive 100 milligram indomethacin suppository. pain intensity will be assessed and recorded using a verbal numeric rating scale, before nasal spray, and in minutes 5, 10, 15, 30, 45 and 60 after receiving the allocated treatment. possible side effects will also be asked and recorded. the patient and the investigator responsible for recording pain intensity will not be aware of the administered drug. the results will be compared before and after treatment in each group, using appropriate statistical tests.

Eligibility criteria:
inclusion criteria: * age: 15 to 65 years * pain intensity of at least 3 * clinical diagnosis of renal colic exclusion criteria: * history of hypertension * history of acute myocardial ischemia * history of hyponatremia * presence of acute rhinitis and flu * coagulopathy or anticoagulant therapy * history of peptic ulcer disease, asthma, renal failure, severe liver failure * analgesic use over 4 hours ago * taking seizure medications (such as carbamazepine) * taking any of the following drugs: chlorpropamide, warfarin, clofibrate , epinephrine, fludrocortisone, heparin, lithium, alcohol

Keywords: renal colic pain desmopressin urinary obstruction indomethacin
oxidative capacity and exercise tolerance in ambulatory sma

Conditions: Spinal Muscular Atrophy Type 3; Mitochondrial Myopathy

Summary: this proposal will focus on (1) estimating oxidative capacity of specific muscle groups during exercise using near infrared spectroscopy and (2) describing body composition to better understand exercise capacity and mitochondrial function in ambulatory spinal muscular atrophy (sma) patients and disease controls. it is a 6-month observational study including 14 ambulatory sma patients, 14 ambulatory patients with mitochondrial myopathy, and 14 healthy controls.

spinal muscular atrophy (sma) is a progressive, recessively-inherited neuromuscular disease characterized by weakness and muscle atrophy due to the loss of spinal cord motor neurons. the results from this study would provide preliminary data, using non-invasive methods, on oxidative capacity in ambulatory sma patients and disease controls to aid in the design of exercise intervention studies. furthermore, this information would link previous laboratory and preclinical findings of mitochondrial depletion in sma to the clinical condition and provide important information for future studies designed to improve oxidative capacity and fitness in sma patients.

Eligibility criteria:
inclusion criteria: 1. one of the following categories: * genetic confirmation of sma with laboratory documentation of homozygous deletion of smn1 exon 7; * genetic confirmation of mitochondrial myopathy or evidence from muscle biopsy confirming the diagnosis; or * healthy individuals. 2. able to walk independently at least 25 meters, and able to tread a stationary cycle ergometer. exclusion criteria: 1. unable to walk 25 meters independently. 2. use of investigational medications intended for the treatment of sma within 30 days prior to study entry. 3. the presence of any contraindication to exercise according the acsm criteria. patients with and without spinraza treatment are eligible.

Keywords: spinal muscular atrophy oxidative capacity exercise tolerance mitochondrial myopathy sma six minute walk test neuromuscular disease ambulation exercise mitochondria cycle ergometry near infrared spectroscopy
sis versus office hysteroscopy for uterine cavity evaluation prior to ivf

Conditions: Infertility

Summary: saline infusion sonography (sis) and hysteroscopy are commonly employed methods for uterine cavity evaluation. while hysteroscopy is regarded as the gold standard for diagnosis of intra-uterine pathology, it is not often used as an initial screening tool because of provider concerns about in-office tolerability, operating room costs, and use of anesthesia. the investigators aim to compare sis and office hysteroscopy with respect to patient and provider satisfaction. additionally, the investigators aim to assess the capability of office-based hysteroscopy to manage intra-uterine pathology at the time of diagnosis and reduce delays and supernumerary procedures.

saline infusion sonography (sis) and hysteroscopy are commonly employed methods for uterine cavity evaluation. sis is often performed as a screening tool in the office for uterine evaluation since it is straight-forward to perform, well-tolerated has low overhead cost. if uterine pathology is suspected on sis, subsequent hysteroscopy is typically performed in the operating room. hysteroscopy remains the gold standard for diagnosis of intra-uterine pathology and offers the opportunity for intervention at time of diagnosis, but often is not used as the initial screening tool because of provider concerns about in-office tolerability, equipment cost and maintenance. technology advancements, however, has introduced an affordable, disposable, small caliber hysteroscopes with an operative channel to make it possible for this type of assessment to be performed in the office setting with the addition of a 'see and treat' modality. if used to perform initial uterine cavity evaluation, hysteroscopy may offer expedited diagnosis, treatment, and avoidance of general anesthesia. if superior specificity is demonstrated, it may also lower the false positive rate, preventing unnecessary delays to a patient's projected treatment plan, and unnecessary exposure to anesthesia risks. to date, no randomized control trials have compared the satisfaction of patients and providers to saline infusion sonography versus office hysteroscopy without anesthesia in initial cavity evaluation with the ability to immediately address intra-uterine pathology.

Eligibility criteria:
inclusion criteria: * women aged 18 - 50 * patients undergoing routine cavity evaluation for planned in vitro-fertilization cycles exclusion criteria: * clinical or radiologic suspicion of intrauterine pathology including myomas, severe intrauterine adhesions or retained products of conception * those with medical criteria not suitable office hysteroscopy due to requirement of advanced tools or preparation not available in the office such as history of bleeding disorder or medical co-morbidity

Keywords: assisted reproduction
psychological and pain factors in knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: this study aims to determine if baseline measures of psychology and pain sensitivity can predict changes in physical function at 1 year in patients with knee osteoarthritis.


Eligibility criteria:
inclusion criteria: * physician diagnosis of knee oa based on clinical and radiographic acr criteria * pain in or around the knee on most days of the past month * aged 40 years or above * ambulatory with or without walking aid exclusion criteria: * inflammatory arthritis (rheumatoid arthritis, lupus, etc.) * recent knee injury or surgery (past 3 months) * severe comorbidity likely to prevent study completion (dementia, terminal illness) * inability to comply with study procedures or follow up
the prone xlif. a pilot study

Conditions: Spinal Diseases

Summary: observational prospective study to evaluate the feasibility, effectiveness and the rate of complications of the xlif (extreme lateral interbody fusion) performed in prone position to treat spinal diseases of the lumbar region.


Eligibility criteria:
inclusion criteria: * age ≥ 18 * patients suffering from lumbar spinal disease that requires a circumferential fusion * patients suitable to undergo spinal fusion with an xlif technique (according to the label indication/contraindications) * patients who are willing and able to provide written informed consent to surgery and study exclusion criteria: * a congenital or post-traumatic vertebral abnormality at the target level * patients with a previous abdominal retroperitoneal surgery * patients that refuses/not suitable to undergo a xlif surgery in prone position * subjects that are unable to provide a written informed consent to surgery and study * subjects that are unable to will or intend * pregnant women (declared before surgery)
eus guided core liver biopsy and igb placement for the diagnosis and management of nash and obesity

Conditions: Obesity; Non-Alcoholic Steatohepatitis

Summary: this study is designed to investigate the impact of weight loss achieved with the igb on nash with early fibrosis in a select cohort of patients with obesity preselected to have a high pre-test probability of having nash with early fibrosis based on magnetic resonance elastography (mre)-hepatogram. in addition, this study will explore potential non-invasive imaging criteria for nash and early fibrosis using eus-elastography.


Eligibility criteria:
inclusion criteria: * patients diagnosed with non-alcoholic steatohepatitis with early evidence of fibrosis as seen on mre-hepatogram * referred clinically for an intragastric balloon placement for weight loss exclusion criteria: * women who are pregnant or plan to be pregnant or are breastfeeding * previous history of gastric surgery * current or recent (within 6 months) gastric or duodenal ulcers * gastroparesis * liver cirrhosis * coagulopathy or active use of coagulation * inability to provide a written informed consent

Keywords: non-alcoholic steatohepatitis (nash) nash with fibrosis intragastric balloon orbera orbera intragastric balloon
iron metabolism in cystic fibrosis

Conditions: Iron Metabolism, Cystic Fibrosis

Summary: iron is a biologically essential micronutrient. iron deficiency alters erythropoiesis and is considered as a major cause of disability worldwide. interestingly, iron overload is never observed in cystic fibrosis contrarily to others chronic respiratory diseases. moreover, iron deficiency reported prevalence in cf is very high (up to 60% in retrospective series) and is correlated to an alteration of respiratory function. cystic fibrosis patients should be tested annually for iron deficiency. serum ferritin is the best diagnosis tool for iron deficiency (specificity 87% for a threshold \< 30 µg/l). previously published studies used less performant markers such as serum iron (\< 12 µmol/l) or transferrin saturation (\< 12%), which are markedly influenced by the systemic inflammation. cf patients experiences frequent pulmonary exacerbations leading to systemic inflammation: iron stores should therefore be assessed at optimal time with no inflammation. the i-muco study aims to determine the exact prevalence of iron deficiency in cf patients. we aimed to identify risk factors for iron deficiency onset.


Eligibility criteria:
inclusion criteria: * cystic fibrosis genetically proven. * age ≥ 18 years * systematic annual follow-up. exclusion criteria: * dietary or drugs iron supplements * systemic inflammation or pulmonary exacerbation * lung transplantation
molecular genetics in infantile spasms

Conditions: Infantile Spasms; West Syndrome

Summary: infantile spasms syndrome (iss) is a characterized by epileptic spasms occurring in clusters with an onset in the first year of life. west syndrome represents a subset of iss that associates spasms in clusters, a hypsarrhythmia eeg pattern and a developmental arrest or regression. aetiology of iss is widely heterogeneous including many genetic causes. many patients, however, remain without etiological diagnosis, which is critical for prognostic purpose and genetic counselling. in the present study, the investigators performed genetic screening of 73 patients with different types of iss by array-cgh and molecular analysis of 5 genes: cdkl5, stxbp1, kcnq2, and grin2a, whose mutations cause different types of epileptic encephalopathies, including iss, as well as magi2, which was suggested to be related to a subset of iss.


Eligibility criteria:
inclusion criteria: * infantile spams or west syndrome exclusion criteria: * brain malformation * clinical features of tuberous sclerosis * abnormal metabolic assays

Keywords: infantile spasms west syndrome variant mutation cnv sequencing