Kornimate/medical-research-clean huggingface dataset:
tdn, manual therapy and exercise for the management of achilles tendinopathy

Conditions: Achilles Tendon Injury

Summary: conflicting evidence exists regarding the recommendations from the orthopaedic section of the american physical therapy association for treatment of achilles tendinitis. trigger point dry needling is effective in reducing pain in several body regions, but no published (tdn) studies are found reporting the effect on achilles tendinopathy. the purpose of this study is to investigate whether a treatment program performed including tdn, manual therapy and exercise will result in a significant improvement in pain, strength and function compared to a treatment program including manual therapy and exercise for achilles tendinopathy. subjects with achilles tendinopathy that receive treatment including tdn, manual therapy and exercise will demonstrate a significant improvement in pain, strength and functional outcomes compared to the group that receives manual therapy and exercise.

this study is a randomized controlled trial, pretest-posttest control group design comparing the effect of tdn, manual therapy and exercise to manual therapy and exercise on human subjects with achilles tendinopathy following eight treatments in four weeks and a follow up examination at three months.

Eligibility criteria:
inclusion criteria: 1. pain onset greater than 4 weeks 2. primary region of pain 2-6 cm proximal to the insertion on the calcaneus 3. read and write in english exclusion criteria: 1. fear of needles or unwilling to have needling performed due to fear or personal beliefs. 2. vascular or sensory disturbances in the lower leg which include but is not limited to injury to the nerve root or peripheral nerve in the affected lower leg, inflammatory diseases, bleeding or clotting disorders, lymphedema, peripheral vascular or peripheral arterial disease. diabetes is included in this group due to the progressive changes to the sensation and circulation in the lower extremities. 3. recent infection. 4. previous surgery to the foot/ankle. 5. steroid by injection or transdermal delivery to the posterior heel within three months. 6. full rupture of the achilles tendon. 7. pregnant or may be pregnant. 8. participants with a work related injury insured by the bureau of worker's compensation or involved in litigation related to injury of the lower leg, foot or ankle.
hormonal effects on pain perception

Conditions: Pregnancy; Progesterone Levels; Pregnancy Associated Analgesia

Summary: to investigate if labor pain is affected by mother's hormone levels. the hormonal effects of pregnancy are well documented. although differences in pain sensitivity between women and men are partly attributable to social conditioning and to psychosocial factors, many laboratory studies of humans have described sex differences in sensitivity to noxious stimuli, suggesting that biological mechanisms underlie such differences. some animal studies have suggested that sensitivity to pain decreases during pregnancy because of the progressive activation of endogenous pain inhibitory systems. this effect may be mediated by pregnancy-associated hormones, in particular progesterone.


Eligibility criteria:
inclusion criteria: * healthy pregnant women at term (\>37ga) exclusion criteria: * chronic pain * regular analgesic medication * severe cardiopulmonary problems * very difficult intravenous access * advanced labor * precipitous delivery
ghrelin suppression by octreotide in prader-willi

Conditions: Prader Willis Syndrome

Summary: the purpose of this study is to learn more about how octreotide (sandostatin lar® depot) affects levels of ghrelin, hunger, and body weight in people with prader-willi syndrome.

after baseline tests, a nurse will administer monthly injections of sandostatin lar® or placebo for 6 months. at the end of this initial 6-month treatment period and a 4-month washout period, study subjects will then crossover to receive the alternative therapy (placebo or octreotide) for an additional 6 months. subjects will be followed for 16 months total at scheduled visits: 0, 2, 6, 10, 12, and 16 months (table 2).

Eligibility criteria:
inclusion criteria: * o diagnosis of pws confirmed by chromosome analysis (i.e. interstitial deletion of paternally-derived chromosome 15q, uniparental maternal disomy or other chromosome 15 abnormalities) * age 18 years and older * written informed consent obtained (by subject or guardian) and willingness to comply with the study schedule and procedures * free t4, tsh values in the normal range (with or without thyroxine replacement) * subjects with confirmed hypogonadism who are corrected with adequate doses of sex steroid replacement, will have been treated for at least 6 months prior to entry and have no change in dosages over the study period. * patients with confirmed growth hormone deficiency who are corrected with adequate doses of replacement, will have been treated for at least 6 months prior to entry and have no change in dosages over the study period. exclusion criteria: * symptomatic gallstones. * smokers. * alcohol consumption \> 2 drinks per day. * exercise \> 30 minutes 3 times a week. * weight \> 500 lbs (exceeds the limit for the bodpod). * active pulmonary infection. * sleep disorder. * subjects will be excluded if they have clinically significant disease that would have an impact on metabolic outcomes or body composition including diabetes mellitus, chronic inflammatory bowel disease, chronic severe liver or kidney disease, heart disease, cancer, symptomatic gallstones, or neurological disorders * history of hepatic disease (patients with minimal, i.e., \<3xs the upper limit of normal for lfts indicative of hepatic steatosis, may participate) * pregnant or lactating * known hypersensitivity to sandostatin acetate or other related drug or compound * subjects who exhibit symptoms indicative of intolerance following the 100 mcg test dose of sandostatin injection, sc * subjects who have previously received sandostatin® (octreotide) * subjects who have received other investigational drugs administered or received within 30 days of study entry

Keywords: obesity
the electronic asthma action plan system for implementation in primary care

Conditions: Asthma

Summary: asthma is a common and potentially fatal chronic disease. an asthma action plan (aap) is a written plan produced by a physician for a patient with asthma, to provide education and guidelines for self-management of worsening asthma symptoms. studies have shown that aaps effectively improve asthma control, but physicians fail to provide aaps due to lack of time and adequate skills. physicians also often fail to determine if their patients have good asthma control, and to adjust medications in response to patients' control level. the investigators propose to develop and test a computerized tool that will help physicians to determine if their patients' asthma is well controlled, advise them on medication changes required according to the current level of control, and automatically generate an electronic version of the aap, all based on patient responses to a questionnaire. the investigators hope that this system will eliminate the barriers that physicians face in determining asthma control, adjusting medications, and delivering an aap, and will increase the frequency with which physicians are able to achieve these goals in patients with asthma. the objectives of the study are to determine the impact of this system on asthma action plan delivery by primary care physicians, the frequency of checking control level, and the frequency and appropriateness of asthma medication changes (in accordance with control). we will also attempt to determine the impact of the system on hospitalisations, emergency room (er) visits, unscheduled visits to the doctor, total visits to the doctor, days off work or school, nocturnal asthma symptoms, daytime asthma symptoms, daytime rescue puffer use, and quality of life, and to measure physicians' perceptions of and satisfaction with the system.

this is a 2-year prospective interrupted time series (its) study of usual asthma care (baseline period) (year 1) compared to care with the eaaps in place (intervention period) (year 2). the setting is two academic family health teams (primary health care teams including family physicians, nurses, and allied health members) in hamilton, ontario and one community-based family health team in brampton, ontario.

Eligibility criteria:
inclusion criteria: * eligible physicians will include all primary care physicians at the 4 sites. eligible patients will include: * patients with asthma, as determined by a validated electronic chart record search algorithm for asthma and on an asthma medication \[but not a chronic obstructive pulmonary disease (copd) medication\] within 1 year; * patients \>/= 16 years of age who understand english exclusion criteria: * pregnant patients will be excluded given that conventional aap recommendations may not be appropriate in this population. * any patient deemed to have cognitive limitations or a life expectancy of \< 1 year
a double-blind randomized clinical trial of a rifabutin regimen in the treatment of mycobacterium-avium complex (mac) bacteremia in patients with aids

Conditions: Mycobacterium Avium-Intracellulare Infection; HIV Infections

Summary: to determine if a drug regimen containing rifabutin will eradicate or decrease the numbers of mycobacterium avium complex (mac) organisms in blood, improve the symptoms associated with mac infection, and increase survival in patients with aids. to assess the safety of the drug regimen.


Eligibility criteria:
inclusion criteria concurrent medication: allowed: * zidovudine (azt). * didanosine (ddi). patients must have the following: * diagnosis of aids as defined by the cdc. * blood cultures positive for mycobacterium avium complex or for acid-fast bacilli (afb). * provide written informed consent. prior medication: allowed: * if receiving zidovudine (azt) or ddi must be taking the medication for at least 4 weeks prior to study entry. * required: * antipneumocystis prophylactic therapy for at least 4 weeks prior to study entry. exclusion criteria co-existing condition: patients with the following conditions or symptoms are excluded: * known hypersensitivity to any of the study drugs. concurrent medication: excluded: * other therapy for mycobacterial disease. patients with the following are excluded: * known hypersensitivity to any of the study drugs. prior medication: excluded within 4 weeks: * therapy for mycobacterial disease. * antiretroviral drugs, other than zidovudine (azt) or ddi. * investigational drugs, other than ddi.

Keywords: rifabutin mycobacterium avium-intracellulare infection acquired immunodeficiency syndrome
study the safety and effectiveness of tadalafil in men with problems getting or maintaining an erection when taken prior to desiring an erection

Conditions: Impotence

Summary: study to determine how safe and effective tadalafil is for japanese men taking it when they need to get and keep an erection.


Eligibility criteria:
inclusion criteria: * 3 months history of erectile dysfunction (ed) * anticipate a monogamous relationship with a female sexual partner * be able to make minimum required sexual intercourse attempts * abstain from using any other ed treatment exclusion criteria: * other primary sexual disorders * history of radical prostatectomy or other pelvic surgery that affected being able to have an erection * history of penile implant or clinically significant penile deformity. * nitrate use * certain heart problems
liver transplantation in patients with unresectable colorectal liver metastases

Conditions: Colorectal Cancer; Metastatic Liver Cancer; Liver Metastases

Summary: multicentric prospective and observational study to assess the 5-year overall survival in a cohort of patients with unresectable liver-only colorectal metastases, well controlled by chemotherapy prior to liver transplantation.


Eligibility criteria:
inclusion criteria: * ≥ 18 and ≤ years * good performance status, ecog 0 or 1 * resected adenocarcinoma in colon or rectum (r0 resection) * unresectable liver metastases * no extrahepatic disease * normal blood tests * response to ≤ 2 lines of chemotherapy (recist criteria) * ≥ 1 year period since diagnosis of colorectal cancer to enrolment in liver transplant waiting list * signed informed consent exclusion criteria: * body mass index ≥ 30 * positive hiv or hcv * pregnancy at the time of inclusion * braf mutated status * deterioration of general condition (10% weight loss in the prior 6 months) * other malignancy with disease free survival \< 5 years * concomitant or prior extrahepatic metastases (histologically or radiologically proved), even if surgically resected. * palliative resection of primary colorectal adenocarcinoma * liver metastases size \> 5 cm (in the last imaging technique) * cea \> 80 ng/ml (at time of enrolment in waiting list) * no neoadjuvant chemotherapy treatment * general contraindication to liver transplantation
improving the efficacy of sacral nerve stimulation for fecal incontinence by alteration of stimulation parameters

Conditions: Fecal Incontinence

Summary: faecal incontinence is a devastating condition affecting 2,2 to 5 % of the adult population. the magnitude of the problem is probably underestimated. sacral nerve stimulation (sns), has over the last decade given hope to patient failing conservative treatment. some patient do not have optimal continence after sns-therapy. this study aims to identify optimal stimulation parameters - that will improve the functional outcome of sns-therapy thru a double blinded randomized cross-over study.

faecal incontinence is a devastating condition affecting daily living and has major influences on quality of life. faecal incontinence affects 2,2 to 5 % of the adult population. the magnitude of the problem is probably underestimated, because most patients don't discuss this affliction with their general practitioner. a new treatment, sns has over the last decade given new hope to these patients. but a group of these patients has minor effect of the treatment - despite a satisfactory test-stimulation period. this study aims to identify optimal stimulation parameters that will improve patient continence and quality of life. four different stimulation parameters will be tested through a double blind, randomized crossover study - standard stimulation parameters (frequency: 14 hz, pulse width 210 microsec.) will serve as control stimulation. the study includes five arms that will be tested in a randomized order. each arm will be tested for four weeks in which the patient fill in bowel habit diaries and standardized questionnaires. the first week in each period will not be evaluated - is serves as a wash-out period. before any pacemaker changes anorectal manometry and rectal filling tests will be performed.

Eligibility criteria:
inclusion criteria: * informed consent * diagnosed with idiopathic faecal incontinence,incontinence with minor (≤60 degrees) sphincteric defects or incontinence following sphincter repair. * medtronic interstim ipg(pacemaker)implanted for more than 6 months * minimum one incontinence episodes pr. week during ongoing sns-therapy exclusion criteria: * colorectal surgery after ipg-implantation * pregnancy or breastfeeding * anal/perianal pain or discomfort * patients who are not deemed able to follow the planned testing program, including mental illness or mentally unstable patients * medication with known effects on gastrointestinal motility, thyroid disease, diabetes, coeliac, neurological disorders. * spinal cord injury * irritable bowel syndrome

Keywords: idiopathic fecal incontinence fecal incontinence sacral nerve stimulation sacral nerve neuromodulation
venous disease in pediatric population

Conditions: Chronic Venous Insufficiency; Pediatric ALL

Summary: chronic venous disease (cvd) is widespread in adult subjects of western countries and is responsible of important morbidity and healthcare costs. cvd has never been extensively studied in pediatric population where the early pathophysiological alterations may occur undetected. the aim of this study is to assess the prevalence of cvd searching also for the early clinical and instrumental signs of this disease.

chronic venous disease (cvd) of lower limbs for its high prevalence in adult population represents one of the main causes of morbidity in western countries, and it has also an important effect on healthcare cost absorbing 1-2% of the total health budget in western countries. clinical manifestations related to cvd are well documented in adults, with clinical guidelines that standardize both diagnosis and treatment. nevertheless, there is a scarcity of published data regarding cvd in children, and in addition, venous duplex ultrasound test of the lower limbs is performed much less commonly in children than in adults. therefore, the natural history of pediatric venous reflux remains unclear, although it is possible that it precedes the onset of cvd in adulthood. in this context, this observational study aims to identify the presence of venous reflux, as well as clinical and morphological data in pediatric subjects, aged between 9 and 18 years old, by performing an office vascular visit and an echo duplex scan of lower limbs. the endpoints of this study are to prospectively assess the prevalence of cvd in children, as well as to evaluate a possible correlation between vein diameter and pathological vein reflux.

Eligibility criteria:
inclusion criteria: * pediatric patients exclusion criteria: * patients with mental retardation * patients with marfan syndrome * patients with an inability to stand or collaborate for the clinical tests.

Keywords: chronic venous disease pediatrics vein reflux
a study to test the long-term treatment of bimekizumab in study participants with moderate to severe hidradenitis suppurativa

Conditions: Hidradenitis Suppurativa

Summary: the purpose of the study is to evaluate the safety of long-term therapy of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (hs)


Eligibility criteria:
inclusion criteria: * study participant has completed the maintenance treatment period through week 48 in hs0003 (nct04242446) or hs0004 (nct04242498), was eligible to receive bimekizumab at the time of completing the feeder study, and did not meet any withdrawal criteria of the feeder study * study participant is considered reliable and capable of adhering to the protocol (eg, able to understand and complete questionnaires), visit schedule, and medication intake according to the judgement of the investigator * a female study participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: 1. not a woman of childbearing potential (wocbp) or 2. a wocbp who agrees to follow the contraceptive guidance during the open-label extension period and for at least 20 weeks after the final dose of investigational medicinal product (imp) exclusion criteria: * female study participant who is breastfeeding, pregnant, or plans to become pregnant during the study or within 20 weeks following the final dose of investigational medicinal product (imp) * study participant has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the participant's ability to participate in this study as determined by the investigator based on protocol required assessments note: for any study participant with an ongoing serious adverse event (sae) from hs0003 (nct04242446) or hs0004 (nct04242498), or any current sign or symptom that may indicate a medically significant active infection (except for the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of study entry or a history of serious infections in hs0003 or hs0004, the medical monitor must be consulted prior to the study participant's entry into hs0005, although the decision on whether to enroll the participant remains with the investigator. * study participant has a positive or indeterminate interferon-gamma release assay (igra) in a feeder study, unless appropriately evaluated and treated * study participant has ongoing or planned use of prohibited hidradenitis suppurativa (hs) or non-hs treatment * study participant plans to participate in another study of a medicinal product or device under investigation during this study

Keywords: bimekizumab ucb4940 hs hidradenitis suppurativa acne inversa
a multicenter assessment of ald403 in frequent episodic migraine

Conditions: Migraine Disorders

Summary: the purpose of this study is to assess ald403 in the prevention of migraine headache in frequent episodic migraineurs.


Eligibility criteria:
inclusion criteria: * diagnosis of migraine at ≤ 50 years of age (ichd-ii, 2004 section 1) * history of migraine ≥ 12 months with * ≤ 14 headache days of which at least 4 have to be migraine days (migraine days count as headache days) in each 28 day period in the 3 months prior to screening * during the 28 days following the screening visit, the subject experiences ≤ 14 headache days of which at least 4 have to be migraine days (migraine days count as headache days) as recorded in the ediary * no use of any botulinum toxin for migraine or for any other medical/cosmetic reasons requiring injections in the head, face, or neck 4 months prior to screening and during the 28 day period prior to randomization * headache ediary was completed on at least 25 of the 28 days prior to randomization exclusion criteria: * confounding pain syndromes, e.g. fibromyalgia, complex regional pain syndrome or any pain syndrome that requires regular analgesia * psychiatric conditions that are uncontrolled and untreated, including conditions that are not controlled for a minimum of 6 months prior to screening * history or diagnosis of complicated migraine (ichd- ii, 2004 section 1), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, migraine with brainstem aura, sporadic and familial hemiplegic migraine * unable to differentiate migraine from other headaches * have any clinically significant concurrent medical condition * receipt of any monoclonal antibody treatment within 6 months of screening (within or outside a clinical trial) * previously dosed with ald403 or any monoclonal antibody targeting the cgrp pathway