Kornimate/medical-research-clean huggingface dataset:
combined corticosteroid injections and shockwave therapy for sacroiliac joint pain

Conditions: Sacroiliac Joint Dysfunction; Sacroiliac Joint Pain

Summary: this study aims to investigate the combined use of corticosteroid injections and eswt for sij pain.

the most common primary cause of pain and stiffness from the sij is sacroiliac joint dysfunction. currently, conservative treatments for sij dysfunction-related pain include oral anti-inflammatory pain medications, exercise therapy, physical therapy, and local injection therapies such as corticosteroids, dextrose, and platelet-rich plasma. although there are multiple non-surgical options available for sij pain management, clear treatment guidelines have not yet been established. among these options, intra-articular corticosteroid injections in the sij are frequently used by rehabilitation specialists in clinical practice, and their effectiveness in relieving pain from sij dysfunction has been demonstrated. however, the effects of corticosteroids in treating musculoskeletal-related diseases are typically short-term. extracorporeal shock wave therapy (eswt) has become increasingly common in the management of musculoskeletal conditions such as calcific tendinitis, tennis elbow, and plantar fasciitis, showing long-lasting benefits and inducing tissue repair responses that studies suggest may last up to two years. however, literature on eswt for lower back pain is limited, and research on its use for sij pain is even rarer. therefore, this study aims to investigate the combined use of corticosteroid injections and eswt for sij pain, aiming to achieve rapid, short-term pain relief through corticosteroid injections, followed by potential long-term effects through eswt.

Eligibility criteria:
inclusion criteria: * low back pain lasting for 3 months or more * pain vas score of 4 or higher * three or more positive results in sacroiliac joint provocation tests * at least 50% pain relief following ultrasound-guided sacroiliac joint injection with local anesthetic exclusion criteria: * currently undergoing extracorporeal shockwave therapy in other areas * suspected pain caused by other lumbar spine or hip joint conditions (e.g., lumbar spine or disc disorders, radicular pain, spondylolisthesis/disc degeneration, hip arthritis) * presence of complex comorbidities, including trauma, systemic infections (e.g., fever, chills, night sweats), local sacroiliac joint infections, autoimmune diseases, or immunosuppression * sacroiliac joint injection therapy received within the past 6 months * contraindications for extracorporeal shockwave therapy (e.g., cancer or current/prior infections at the treatment site, pacemakers, pregnancy, epilepsy, or coagulation disorders caused by disease or medication) * impaired renal function preventing the administration of contrast agents for sacroiliac joint bone scanning

Keywords: sacroiliac joint dysfunction sacroiliac joint pain steroid injection extracorporeal shock wave therapy
a phase 3 clinical study patients with androgenetic alopecia (aga)

Conditions: AGA

Summary: a multicenter, randomized, double-blind, and placebo-controlled phase 3 clinical study ,the mean change from baseline in vertex target area hair count (tahc) after treatment for 24 weeks.


Eligibility criteria:
inclusion criteria: 1. having voluntarily signed the icf approved by the ethics committee and consented to participate in this study before starting any study procedure; 2. being able to understand and comply with the requirements of the protocol and agreeing to participate in all study visits; 3. males aged 18 to 41 years (inclusive); 4. being diagnosed with type iii vertex, type iv or type v androgenetic alopecia (aga) according to the hamilton-norwood classification (see appendix 1 for details); 5. appropriate medical contraceptive methods being used to prevent the sexual partner from becoming pregnant from the time of signing icf to 28 days after the last dose; - exclusion criteria: 1. a history of scalp skin abnormalities or scalp skin diseases at the time of screening 2. patients with secondary alopecia such as those associated with malnutrition, drugs, endocrine , iron deficiency anemia, or systemic lupus erythematosus; 3. patients with alopecia areata, alopecia cicatrisata, or trichotillomania; 4. having undergone hair transplantation or extension before screening, or persistent requirement to wear a wig sheath during study treatments; 5. known allergy to the active ingredient of the investigational drug or any component of the excipients, or to any component of the tattoo liquid; 6. a history of depression, anxiety, personality disorder or other mental disorders; 7. a history of varicocele or infertility ; 8. a history of malignant tumor;
use of faecal calprotectin to predict enteropathy of the preterm neonates

Conditions: Enteropathy, Necrotizing Enterocolitis

Summary: this study aims to evaluate a clinico-biological predictive score, associating the faecal calprotectin, for the diagnosis of enterocolitis and enteropathy of the preterm neonates.

enteropathy and necrotizing enterocolitis (nec) are digestive emergencies in premature neonates which represent a major concern for the vital prognosis. it is therefore important to propose a tool for early diagnosis of these intestinal complications in order to avoid extended interruptions of enteral feeding at a period of life where growth (and digestive maturation) is in the foreground. currently, the diagnosis of digestive impairment is based on classical clinical, biological (crp, procalcitonin, fecal calprotectin, nfs) and radiological (abdomen without preparation) approaches, which induce on one hand a prolonged interruption of enteral feeding sometimes useless and even harmful for the intestinal maturation and, secondly, the establishment of a parenteral nutrition which is not risk-free. the study propose to dose the fecal calprotectin, a non-invasive marker of digestive inflammation, in order to validate the threshold decision proposed in a pilot study (350 µg/g of feces). measurement of fecal calprotectin levels will be used as an integrated tool to build a powerful screening score combined to the usual parameters used in routine care for the diagnosis of and enteropathy and necrotizing enterocolitis (nec) in premature neonates. a cohort of preterm infants born at a gestational age of 33 weeks or less will be included from birth. a stool sample will be collected from the diaper once a week, from birth until discharge from the hospital, and every day during gastrointestinal events (interruption of enteral feeding over 48 hours). the study will evaluate the performance of the rapid assay of fecal calprotectin by quantitative immunochromatography compared to the reference method by enzyme-linked immunosorbent assay (elisa).

Eligibility criteria:
inclusion criteria: * infants prematurely born at a gestational age of 33 weeks or less (or before the 7th month of pregnancy). * patient whose parents or holders of parental authority signed an informed consent. exclusion criteria: * patient with a malformation. * lack of signature of the consent by parents or holders of parental authority.

Keywords: faecal calprotectin feces preterm neonates enterocolitis enteropathy necrotizing
a trial to evaluate the pharmacokinetics of abl001 in healthy and hepatic impaired subjects

Conditions: Hepatic Impairment

Summary: the main purpose of this study is to evaluate the effect of varying degrees of impaired hepatic function (by child-pugh classification) on the pharmacokinetics (pk) of abl001 after a single oral dose.


Eligibility criteria:
key inclusion criteria: * body mass index of 18-36 kg/m2, with body weight 50 kg and no more than 120 kg * vital signs (after at least 3 minutes rest in the supine position) within the following ranges (inclusive): * oral body temperature between 35.0 °c - 37.5 °c (95.0-99.5°f) * systolic bp ≥90 mmhg and ≤140 mmhg * diastolic bp ≥60 mmhg and ≤90 mmhg for healthy subjects and 50-100 mmhg for subjects with impaired hepatic function (groups 2-4) * pulse rate: ≥50 and ≤90 bpm for healthy subjects (group 1) and ≥50 and ≤100 bpm for subjects with impaired hepatic function (groups 2-4) * healthy subjects with no clinically significant abnormalities as determined by past medical history, physical examination, vital signs, ecg, and clinical laboratory test * subjects with child-pugh clinical assessment score as calculated per the child-pugh classification key exclusion criteria: * presence of clinically significant ecg abnormalities or a family history or presence of prolonged qt-interval syndrome * history of cardiac disease * sexually active males must use a condom during intercourse while taking the drug and for 7 days after stopping * any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs * administration of strong or moderate cyp3a4 inhibitors or inducers (including st john's wort) within 14 days prior to dosing other protocol-defined inclusion/exclusion criteria may apply.

Keywords: hepatic impairment abl001 child-pugh healthy subjects with normal hepatic function
high- fiber/ low-fat diet for prevention of recurrent clostridioides difficile infection in oncology

Conditions: Leukemia, Lymphocytic, Acute; Leukemia, Myeloid, Acute; Lymphoma; Clostridium Difficile Infection

Summary: the primary objective of the study is to determine whether dietary intervention to increase fiber and decrease fat reduces c. difficile infection recurrence in a cohort of oncology patients.

this is a randomized study. a total of 124 individuals with either acute leukemia or lymphoma and a first or second occurrence of c. difficile infection will be enrolled. participants will be randomized to arm 1 (diet intervention) or arm 2 (no diet intervention). participants in arm 1 will be assessed for food preferences and will be provided lists of high fiber and high saturated fats. participants will be able to choose foods from the high fiber food lists and groceries will be provided once per week to support each participant's meal plan. participants will be asked to limit foods on the high saturated fats list. food consumption with a 24 hour recall and weight will be monitored and stool samples will be collected one time per week for 6 weeks. in arm 2, participants will be asked to provide 24 hour food recall and stool samples. individuals in both arms will be monitored for stool consistency and any antibiotics or chemotherapy drugs taken. participation will last 6 weeks.

Eligibility criteria:
inclusion criteria: * diagnosis of a malignant neoplasm at the at children's hospital colorado or the university of colorado hospital * diagnosis of first time or first recurrent cdi as defined by clinical criteria within the past 21 days * informed consent obtained and signed. for minors, the consent will be completed by a guardian and the study participant will sign the assent form. only the consent form is required of adults. * 9 years old or older * 40th to 100th percentiles of saturated fat intake and below the 50th percentile for fiber intake based on a food frequency questionnaire. * ability to comply with study procedures for the entire length of the study.
are mast cells involved in autoinflammatory diseases

Conditions: Autoinflammatory Disease; FMF; TRAPS; MKD; Cryopyrin Associated Periodic Syndrome; Haploinsufficiency

Summary: autoinflammatory diseases (aid) are caused by innate immunity dysregulation. aid pathophysiology is only partly understood, especially in the case of unclassified aid. mast cells (mc) are innate immune cells associated with a spectrum of disease between systemic mastocytosis and mast cell activation syndrome. the implication of mc has been shown in cryopyrin associated periodic syndrome (caps).our aim is to evaluate the involvement of mc in aid by assessing clinical and biological signs of mc activation and studying cutaneous and digestive biopsies.

autoinflammatory diseases (aid) are caused by innate immunity dysregulation and characterized by recurrent bouts of fever, frequently associated with digestive, articular or cutaneous symptoms, and sometimes ocular, auricular or neurologic inflammation. the most frequent monogenic aid is familial mediterranean fever (fmf). despite recent genetic progress aid pathophysiology is only partly understood, especially in the case of unclassified aid. mast cells (mc) are innate immune cells associated with a spectrum of disease between systemic mastocytosis and mast cell activation syndrome (mcas). in mcas, patients have various symptoms including abdominal pain, bloating, pruritus, flush, anxiety, fatigue, among which some are similar to those seen in patients with aid. the implication of mc has been shown in cryopyrin associated periodic syndrome (caps). our hypothesis is that mc could be involved in aid pathophysiology, in order to test this hypothesis, we plan to study : * clinical mc activation symptoms via a standardized clinical score * biological mc mediators : by measuring total serum tryptase and histamine in total blood, plasma and urine * mc infiltration on gastro-intestinal (gi) tract and cutaneous biopsies we will compare clinical mc activation score in aid patients to patients with mastocytosis, with other inflammatory diseases, and with healthy controls.

Eligibility criteria:
inclusion criteria: * patients \>18 years old with auto-inflammatory diseases already followed up at the cerémaia (french national reference center for autoinflamamtory diseases and aa amyloidosis) of tenon hospital and included in the jircohorte * healthy adult controls, age- and sex-matched with mai patients, and controls with mastocytosis, an immuno-inflammatory disease. * subject affiliated to or entitled to a social security scheme * collection of the patient's or healthy control's non-opposition exclusion criteria: * subjects unable to answer questions or express themselves * subjects who do not speak french * subject deprived of liberty or under legal protection.

Keywords: autoinflammatory disease mast cells mast cell activation syndrome
long-term outcome in late-onset pompe disease treated beyond 36 months (stig-pompe-study)

Conditions: Pompe Disease

Summary: long-term outcome in late-onset pompe disease treated beyond 36 months (atbig-pompe-study), a multicenter, multinational, longitudinal, non-interventional observational study in subjects, at least 8 years old, diagnosed with late-onset pompe disease retrospectively and prospectively collects data to understand clinical progression in terms of muscle and respiratory function, and clinical symptomology treated with alglucosidase alfa more than 36 months in 100 subjects.

the presentation and course of late-onset pompe disease is much less foreseeable than the classic infantile form. some patients experience a rapid worsening in skeletal muscle function leading to loss of ambulation and respiratory failure, while others progress less rapidly. so there is a more inconstant response to treatment in skeletal muscle and lung function in the long-term. therefore, an unmet clinical need is the collection and analysis of long-term data of rhgaa enzyme replacement therapy (ert) in late-onset pompe disease patient aged 8 years and older. the principal goal of our investigator driven study is to gain conclusive insight in long-term outcome data beyond 36 months up to 10 years of ert treatment. in addition we will collect biological samples from all patients for a future biomarker study including gene modifier search by genome and rna seq (not part of this proposal). this study may provide clinicians and researchers with a better understanding of late-onset pompe disease under long-term treatment, to the benefit of all patients affected with late-onset pompe disease, as well as, individuals and families with related diseases.

Eligibility criteria:
inclusion criteria: * late-onset pompe patients, aged over 8 years. * the patient is willing and able to provide signed informed consent. * the patient (and patient's legal guardian if patient is under 18 years of age) must have the ability to comply with the clinical protocol. * long-term myozyme treatment beyond 36 months. * known gaa genotype. * gaa activity (dried blood spot testing, or other methods). exclusion criteria: * - the patient is concurrently participating in another clinical study using myozyme or other treatment. * the patient, in the opinion of the investigator, is unable to adhere to the requirements of the study. * the patient has clinically significant organic disease (with the exception of symptoms relating to pompe disease), including clinically significant cardiovascular, hepatic, pulmonary, neurologic, or renal disease, or other medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the investigator, precludes participation in the study or potentially decreases survival.
helping young children improve eating

Conditions: Feeding and Eating Disorders of Childhood

Summary: this study will evaluate the impact of different types of educational materials on parent and child feeding behaviors. specifically, the investigators will test the feasibility, acceptability, and effectiveness of an investigator-developed series of parent training videos designed to teach behavioral strategies to promote feeding in young children with feeding difficulties.


Eligibility criteria:
inclusion criteria: * parents of patients ages 18 months through 6 years currently on the waitlist (for an estimated time of at least 4-6 weeks) for outpatient feeding therapy, or with feeding concerns identified in a primary care visit; english-speaking parents; parent has the technology to access the videos and redcap survey. exclusion criteria: * parents of patients not currently eating by mouth; parents of patients currently being treated by a psychologist, occupational therapist, or speech therapist to address feeding, eating, or swallowing skills; parents of patients who have aspirated on their most recent videofluoroscopic swallow study or who currently have a tracheostomy.
ondansetron prior spinal anaesthesia

Conditions: Cesarean Section

Summary: since ondansetron is commonly used during cesarean deliveries to treat nausea and vomiting, this study will observe the correlation between ondansetron administration and effect on hemodynamics in order to confirm that the use of ondansetron can reduce incidence of hypotension and bradycardia associated with spinal in cesarean section, and to identify the optimal timing and dose for administration.

hypothesis: administration of ondansetron prior to spinal anesthesia can attenuate hypotension and bradycardia. aim: since ondansetron is commonly used during cesarean deliveries to treat nausea and vomiting, this study will observe the correlation between ondansetron administration and effect on hemodynamics in order to confirm that the use of ondansetron can reduce incidence of hypotension and bradycardia associated with spinal in cesarean section, and to identify the optimal timing and dose for administration. objectives: * primary outcome: incidence of hypotension after spinal anaesthesia in the patients who received ondansetron and those who did not * secondary outcome : use of vasopressors , bradycardia , timing of administration of ondansetron wether it is more or less than five minutes prior to the administration of anesthesia.

Eligibility criteria:
inclusion criteria: * pregnant patients undergoing elective caesarean section exclusion criteria: * preeclampsia * eclampsia * hypertension * diabetes

Keywords: spinal anesthesia, cesarean section, ondansetron
rehabilitation in chronic obstructive pulmonary disease (copd) patients with emphysema

Conditions: Chronic Obstructive Pulmonary Disease; Emphysema

Summary: chronic obstructive pulmonary disease has two heterogeneous conditions (chronic bronchitis and pulmonary emphysema phenotypes) with a different clinical presentation. the phenotype evaluation in copd patient (trough clinical, functional and radiographic parameters) could influence final results in pharmacologic and non-pharmacologic management of the disease. the aim of our study is to investigate whether copd patients with different disease phenotype (chronic bronchitis versus pulmonary emphysema) have a different response to pr.


Eligibility criteria:
inclusion criteria: * copd disease with any functional grade * adherence to participate to a pulmonary rehabilitation program exclusion criteria: * recent acute exacerbation (4 weeks preceding enrollment) * acute severe concomitant cardiovascular diseases * concomitant neoplastic diseases * no-adherence to participate to a pulmonary rehabilitation program

Keywords: copd emphysema phenotype
metabolic studies- interactions between gh and insulin in ghda

Conditions: Insulin Resistance

Summary: the purpose og this study is to investigate the effects of growth hormon on insulin signalling pathways and the temporal association between administration of gh and developing of insulin resistance.

insulin resistance is a pathophysiological component of type 2 diabetes, obesity and elevated blood pressure. overall they are syndromes with multifactorial ethology and partly unclarified pathophysiology. insulin resistance also occur in more seldom diseases with a more unified pathogenesis. growth hormone deficiency (ghd) in adults with hypopituitarism is an example of one of those seldom diseases. prolonged ghd is associated with abdominal overweight, dyslipidemia and increased cardiovascular morbidity. besides, ghd-patients have decreased insulin sensitivity presumably secondary to the altered body composition. long term effects of gh-substitution improves insulin sensitivity but it is well-known that subcutaneous administration of gh acute worsen insulin sensitivity in both muscles- and liver-tissue. recently it has been reported that insulin resistance in patients with type 2 diabetes is associated with the induction of a signal protein called suppressor of cytokine signalling (socs). it´s interesting that gh also induces a stimulation of socs.

Eligibility criteria:
inclusion criteria: * written consent before study start * growth hormone substitution in stable dosis for at least 3 months prior to study start * other substitution in stable dosis for at least 3 months prior to study start exclusion criteria: * medical treatment for diabetes * hypertension even with medical treatment * bmi \> 30 * excessive alcohol abuse

Keywords: growth hormone gh signaling insulin resistance insulin signaling
treatment of acute leukemia relapse after allotransplantation

Conditions: Acute Myeloid Leukemia

Summary: patients with relapse of acute leukemia often only receive supportive therapy. our hypothesis is that a combination therapy can stabilize the disease for patients with early relapse after allogeneic stem cell transplantation. the investigators will combine 5-azacitidine 100 mg daily subcutaneously (days 1-3), valproic acid (continuous therapy from day 1), all-trans retinoic acid (days 1-14) and hydroxurea (continuous treatment from day 15 of first cycle. azacitidine and atra can be repeated with 5 weeks intervals, donor leukocyte infusions on day 10 is allowed from the second cycle.


Eligibility criteria:
inclusion criteria: * aml relapse within one year after transplantation * blood and marrow sampling being possible * expected survival at least 4 weeks * no expected drug interactions * informed consent possible exclusion criteria: * intolerance to any study drug * serious kidney or liver disease * informed consent not possible * previous pancreatitis

Keywords: acute myeloid leukemia allogeneic stem cell transplantation relapse disease stabilization, survival