Kornimate/medical-research-clean huggingface dataset:
evaluation of probiotics on symptoms of upper respiratory tract infections

Conditions: Healthy

Summary: the aim of the present prospective study is to investigate whether the consumption of certain probiotic strains over a six-month winter/spring season would be able to affect the incidence and duration of upper respiratory tract infections, in otherwise healthy children as well as determining whether a combination of two strains would perform differently from a single strain version.


Eligibility criteria:
inclusion criteria: * children aged 3-5 years of normal nutritional status and health exclusion criteria: * contraindications to dairy products (lactose intolerance or cow's milk allergy) * indicators of inflammatory disease, intestinal disease, crohn's disease, colitis, celiac disease * chronic cough from recurring respiratory distress-related diseases * hirschsprung's disease * cystic fibrosis * other metabolic, neurological, or anatomic alteration that predisposes participation * intake of probiotics within the last 3 weeks

Keywords: probiotic lactobacillus ncfm bifidobacterium healthy children
an evaluation of the psychological impact of early phase clinical trials in cancer patients.

Conditions: Cancer; Depression; Anxiety; Hope; Psychological Distress

Summary: this is an exploratory prospective observational cohort study to establish the levels of psychological distress in early phase clinical trial patients and evaluate the psychological impact of early phase clinical trials on cancer patients. participants will be requested to complete self-reported questionnaires, measuring levels of anxiety, depression and hope, at different time points along the clinical trials pathway.


Eligibility criteria:
inclusion criteria: * aged 18 years and older * able to provide informed consent * are being considered for an early phase clinical trial exclusion criteria: * patients unable to comprehend english language

Keywords: clinical trials early phase clinical trials experimental cancer medicine
"effectiveness of the ultrasound - guided lengthening of the gastrocsoleus complex"

Conditions: Gastrocnemius Equinus

Summary: the study analyzes the effectiveness of different ultrasound-guided surgical techniques to treat gastrocnemius contracture and equinus deformity, conditions that affect ankle dorsiflexion and can cause problems such as plantar fasciitis and metatarsalgia. four techniques were compared: strayer, plantaris, baumann and gastro-soleo, evaluating their impact on the improvement of ankle motion.

equinus deformity is a common deformity caused by contracture of the triceps suralis, especially the gastrocnemius. this causes limitation of ankle dorsiflexion, pain and gait incompetence. treatment includes surgical lengthening techniques such as gastrocnemius tendon recession (strayer) or isolated plantar tendon transection. the minimally invasive strayer technique is effective but carries morbidity. ultrasound-guided plantar tendon transection is a new minimally invasive technique but its effectiveness has not been well established. the study will evaluate the effectiveness of four ultrasound-guided surgical techniques in improving ankle dorsiflexion in patients with equinus due to gastrocnemius contracture. the strayer, plantaris, baumann, and gastro-soleo techniques will be compared, analyzing their impact on mobility before and after surgery. patients will be assigned to different groups based on the applied technique, following specific inclusion and exclusion criteria for each procedure. for statistical analysis, wilcoxon and paired student's t-tests will be used, depending on data distribution. additionally, a repeated-measures anova with tukey's post-hoc tests will be applied to compare the results between techniques and determine which achieves the greatest increase in dorsiflexion range. all techniques are expected to significantly improve dorsiflexion, with differences in the magnitude of change. the gastro-soleo technique is anticipated to show the highest absolute increase, while strayer may be the most statistically effective. the study complies with ethical requirements and has the approval of the ethics committee of the catholic university of valencia.

Eligibility criteria:
inclusion criteria: * clinical and radiological diagnosis of clubfoot. * limitation of passive dorsiflexion of the ankle (\<10°). * associated pain and functional limitation * absence of previous ankle/foot surgeries exclusion criteria: * neurologic or congenital disease. * advanced ankle joint osteoarthritis * peripheral vascular insufficiency * uncontrolled diabetes mellitus * severe hepatic or renal disease * coagulopathies or anticoagulant therapy

Keywords: gastrocnemius lengthening equinus contracture correction surgery ankle range of motion improvement orthopedic foot surgery
safety and efficacy of ledipasvir/sofosbuvir fixed dose combination, with or without ribavirin, in egyptian adults with chronic genotype 4 hcv infection

Conditions: Hepatitis C Virus Infection

Summary: the primary objective of this study was to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (ldv/sof) fixed dose combination (fdc) with or without ribavirin (rbv) in egyptian adults with chronic genotype 4 hepatitis c virus (hcv) infection.


Eligibility criteria:
key inclusion criteria: * willing and able to provide written informed consent * chronic hcv infection (≥ 6 months) documented by medical history or liver biopsy * hcv genotype 4 at screening * hcv treatment naive or prior participation in this study or study gs-us-334-0138 (cohorts 1 and 2 only) * cohort 3 only: hcv treatment-experienced (previously received therapy for hcv infection with an interferon (ifn)-containing regimen, with or without rbv and/or an hcv ns3/ns4a protease inhibitor (pi) * body mass index (bmi) ≥ 18 kg/m\^2 * screening laboratory values within defined thresholds * use of effective protocol-approved contraception methods key exclusion criteria: * history of clinically-significant illness or any other major medical disorder that may interfere with treatment, assessment or compliance with the protocol * infection with hepatitis b virus (hbv) or human immunodeficiency virus (hiv) * pregnant or nursing females or male with pregnant female partner * clinically-relevant drug or alcohol abuse within 12 months of screening note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: hcv genotype 4 (gt-4) hcv sustained virologic response direct acting antiviral combination therapy gs-7977 gs-5885 ribavirin sofosbuvir ledipasvir hepatitis c hepatitis c, chronic liver diseases virus diseases antiviral agents
special drug use observational study of xolair in patients with severe to most severe seasonal allergic rhinitis aged ≥ 12 years and < 18 years whose symptoms were inadequately controlled despite to conventional therapies

Conditions: Allergic Rhinitis

Summary: this was a multicenter, uncontrolled, open-label, special drug use study to investigate the safety and efficacy of xolair by collecting data in its clinical setting in patients with severe to most severe seasonal allergic rhinitis aged ≥ 12 years and \< 18 years whose symptoms were inadequately controlled despite to conventional therapies and used xolair.

the observation period lasted for up to 24 weeks, with day 1 defined as the start date of xolair treatment. it should be noted that, because the duration of xolair treatment depends on the pollen dispersal situation and other factors, patients who completed or discontinued xolair treatment before the visit at 24 weeks after the start of treatment were followed up until the date of last dose of xolair + 30 days, and the results were recorded in the crf.

Eligibility criteria:
inclusion criteria: 1. patients who used xolair in accordance with the instructions of package insert 2. patients aged ≥ 12 years and \< 18 years at the start of xolair 3. patients who used xolair for the following indication: indication: seasonal allergic rhinitis (only patients with severe to most severe symptoms whose symptoms were inadequately controlled despite to conventional therapies) 4. patients having provided written consent to participate in this study before the start of xolair in the relevant pollen season, in person and from their legally acceptable representative (legal representative) exclusion criteria: 1. patients with a history of hypersensitivity to any of the xolair ingredients

Keywords: xolair seasonal allergic rhinitis
smoking treatment of prisoners

Conditions: Tobacco Use Cessation; Tobacco Use Disorder

Summary: the purpose of this study is to determine the efficacy of a 10-week smoking cessation therapy combined with nicoderm cq for smoking cessation among female prisoners.

this is a randomized controlled trial utilizing a wait-list control group to examine 10-week group therapy and nicotine replacement compared to wait-list for smoking cessation among female prisoners.

Eligibility criteria:
inclusion criteria: * 1) current smoker and (2) seeking group treatment to quit smoking. exclusion criteria: * (1) non-english speaking, (2) housed in segregation, (3) presence of active, severe mental illness as defined by active psychosis, manic episode, or imminently suicidal/homicidal, (4) mental retardation such that they cannot provide informed consent, and (5) due to be released or transferred to another facility within the next year.

Keywords: nicotine dependence
a study to assess cln® bodywash for reducing skin fauna in patients with hand eczema

Conditions: Eczema; Hand Eczema; Atopic Dermatitis

Summary: the primary objective of this protocol is to acquire pilot data for a larger study to test the following hypothesis: treatment of the hands of patients with chronic hand dermatitis/atopic dermatitis with cln bodywash, a novel gel wash cleanser currently marketed as a cosmetic product containing a dilute concentration of less than 0.01% sodium hypochlorite and less than 0.005% concentration as it is lathered, will result in a statistically significant reduction in the number of skin fauna present on the hands of these patients compared to treatment of such patients with traditional wash used clinically such as cetaphil daily facial cleanser.

patients with hand eczema will be asked to wash with either a cln bodywash or cetaphil daily facial cleanser. patients and study staff will be blinded. hand swabs will be done prior to the wash and after 20 minutes. the average time spent in the study for each patient should be less than 2 hours unless an adverse event occurs.

Eligibility criteria:
inclusion criteria: * seen by an osu dermatology provider at osu dermatology east after the date of approval of this protocol * ability to provide informed consent, or parent or legal guardian capable of providing consent for child or mentally handicapped individuals * willingness to participate in a research study. * diagnosis of chronic hand dermatitis exclusion criteria: * inability to provide informed consent * allergy to any of the treatments used

Keywords: cln body wash cln bodywash
evaluation rehabilitation on glycometabolic state in non-diabetic coronary artery disease (cad) patients

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to evaluate the effects of an intensive cardiac rehabilitation program on glucose metabolism of non-diabetic coronary artery disease patients.


Eligibility criteria:
inclusion criteria: * patients admitted to undergo a cycle of in-hospital cardiac rehabilitation * patients without a previous diagnosis of diabetes mellitus * patients able to start physical training within three days from admission * fasting blood glucose at admission \< 126 mg/dl exclusion criteria: * previous diagnosis of diabetes mellitus * acute coronary events or acute heart failure in the past three months * physical disabilities that contraindicate training

Keywords: exercise training functional recovery heart diseases altered glucose metabolism early after an acute cardiac event non diabetes cad patients glycometabolic state
an intra-individual titration study of krn1493 for the treatment of hypercalcemia in patients with parathyroid carcinoma or intractable primary hyperparathyroidism

Conditions: Parathyroid Carcinoma; Hypercalcemia; Primary Hyperparathyroidism

Summary: this is an intra-individual titration study of krn1493 to evaluate the safety and efficacy of krn1493 for the treatment of hypercalcemia in patients with parathyroid carcinoma or intractable primary hyperparathyroidism (phpt).


Eligibility criteria:
inclusion criteria: * patients who meet any one of the following. patients with a diagnosis of parathyroid carcinoma and corrected serum calcium \> 11.3 mg/dl at the latest screening test. patients with intractable phpt (defined as follows: impossible to localize parathyroid tumor before initial surgery or in relapse after surgery, or impossible to perform parathyroidectomy (ptx) for complications, and corrected serum calcium is \> 12.5 mg/dl at the screening test). * patients who provided their voluntary written informed consent to participate in the study. exclusion criteria: * patients diagnosed with malignant tumor except for parathyroid carcinoma, nonmelanoma skin cancer, and carcinoma in situ of the cervix within 5 years before enrollment. * patients receiving anticancer chemotherapy except for the treatment of parathyroid carcinoma. * patients diagnosed with hypercalcemia associated with malignant tumors other than parathyroid carcinoma. * patients who had hypersensitivities to cinacalcet hcl preparations or vehicles.

Keywords: hypercalcemia in patients with parathyroid carcinoma or intractable phpt
clinical evaluation of silver nanoparticles in comparison to silver diamine fluoride in management of deep carious lesions

Conditions: Caries,Dental

Summary: this clinical study will be carried out to evaluate the effect of fluoride varnish with silver nanoparticles in comparison to silver diamine fluoride in management of deep carious lesions.


Eligibility criteria:
inclusion criteria: * success will be evaluated by: 1. cold pulp testing: an ice-rod will be used for this test. results should be positive or negative. 2. absence of spontaneous pain: post-operative pain will be assessed using the visual analogue scale score (vas), which is a measurement method for subjective characteristics of pain. respondents specify their level of agreement to a statement by indicating a position along a 10 cm line between two end-points, with the term "no sensitivity" at one end and "intolerable sensitivity" at the other end. a score from (0 to 10 is given). 3. sensitivity to percussion: (presence/ absence). 4. inspection for sinus/fistula/swelling: using visual inspection (presence/ absence). 5. radiographic examination: indicating presence of periapical radiolucencies, widening of lamina dura, internal and external root resorption (presence/ absence). exclusion criteria: * patient-related criteria: * medically compromised patients, who will not be able to attend multiple appointments or may require special management. * pregnant women; as radiographs cannot be taken for them. * allergy to any of the restorative materials, including anesthetics. * uncooperative patients, will not abide by the instructions or attend the appointments. tooth related criteria: * retained deciduous teeth; as the study is targeting only permanent teeth. * teeth with previous restorations, which may add another variable to the study (type of old restorative material, extent of recurrent caries. * teeth with cervical caries; which can't be evaluated on periapical radiographs
study evaluating erb-041 with methotrexate in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the primary objective of this study is to compare the efficacy and safety of 3 dose levels of oral erb-041 administered daily for 12 weeks versus placebo in subjects with active rheumatoid arthritis who have had a suboptimal response to therapy with stable doses of methotrexate (mtx).


Eligibility criteria:
inclusion criteria: * clinical diagnosis of active rheumatoid arthritis for at least 6 months and on a stable dose of methotrexate for at least 12 weeks * rheumatoid arthritis onset after 16 years of age exclusion criteria: * any significant health problem other than rheumatoid arthritis * history of male or female reproductive system cancer * clinically significant laboratory abnormalities

Keywords: rheumatoid arthritis
the study on the pharmacokinetics of peg-rhg-csf in children and adolescents

Conditions: Acute Lymphoid Leukemia

Summary: the purpose of the trail is to study the pharmacokinetics of pegylated recombinant human granulocyte stimulating factor（peg-rhg-csf） in children and adolescents


Eligibility criteria:
inclusion criteria: 1. age≤18 years old, gender no limited. 2. patients with acute lymphoblastic leukemia diagnosed by bone marrow pathology or cytology. 3. plan to receive cam (cyclophosphamide,cytarabine,6-mp)chemotherapy regimen. 4. previously not received radiotherapy. 5. karnofsky performance scores ( kps)≥60. 6. the expected survival time was \>3 months. 7. neutropenia or agranulocytosis, no bleeding tendency. 8. no significant cardiac dysfunction or metabolic disease. 9. tbil(total bilirubin ), alt（alanine aminotransferase）,ast（glutamic-oxalacetic transaminase） \< 2.5×uln（upper limit of normal）. 10. bun（blood urine nitrogen），cr（creatinine），ua（uric acid）\<1.5×uln. 11. written informed consent are acquired. exclusion criteria: 1. with a history of systemic radiotherapy. 2. infection difficult to control, the body temperature ≥ 38℃. 3. other situation that investigators consider as contra-indication for this study.
a safety and effectiveness study of tmc435 in chronic, genotype 1, hepatitis c patients who failed to previous standard treatment

Conditions: Hepatitis C

Summary: the purpose of this study is to determine the efficacy, safety and tolerability of different regimens of tmc435 with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis c virus (hcv) infection who has failed previous treatment with pegylated interferon (peg-inf-alfa-2a) and ribavirin (rbv).

the study is a randomized (study drug assigned by chance), double-blind (neither physician nor participant knows the name of the assigned drug), placebo-controlled phase iib trial with tmc435 in participants with chronic, genotype 1, hepatitis c virus (hcv) infection who have failed standard treatment with pegylated interferon (peg-inf-alfa-2a) and ribavirin (rbv). the study will compare the efficacy, tolerability and safety of different regimens with tmc435 combined with standard treatment (peg-inf-alfa-2a and rbv) versus standard treatment alone. the trial will consist of a screening period of maximum 6 weeks, a 48-week treatment period, and a 24-week follow-up period. participants will be eligible to enroll in the trial if they failed to respond to a prior course of standard treatment or relapsed following standard treatment. participants will be randomly assigned to receive tmc435 with standard treatment for 12 weeks followed by standard treatment (plus placebo) for 36 weeks, tmc435 (100 mg or 150 mg once a day) with standard treatment for 24 weeks followed by standard treatment (plus placebo) for 24 weeks, tmc435 (100 mg or 150 mg once a day) with standard treatment for 48 weeks, or a placebo with standard treatment for 48 weeks.

Eligibility criteria:
inclusion criteria: * must have chronic hepatitis c infection as evidenced by liver biopsy, anti-hepatitis c virus (hcv) and hcv rna positive * must have chronic hepatitis c infection (genotype 1) with hcv rna level greater than10000 iu/ml * patient must have failed at least 1 prior course of peg interferon (peg-ifn-alfa-2a)/ribavirin (rbv) therapy (standard treatment) * must be willing to use 2 effective methods of birth control for up to 7 months after last dose of study medication exclusion criteria: * has an evidence of decompensated liver disease * co-infection with any other hepatitis c virus genotype or co-infection with the human immunodeficiency virus (hiv) * has a medical condition which is a contraindication to peg-inf or rbv therapy * have had history of, or any current medical condition which could impact the safety of the patient in the study

Keywords: hepatitis c peginterferon alpha-2a pegifnalpha-2a rbv ribavirin placebo tmc435-tidp16-c206 tmc435-c206 tmc435 hcv
preventive care of chronic cervical pain and disabilities

Conditions: Neck Pain

Summary: the aim of this study is to determine which of tertiary prevention spinal manipulative therapy (smt) or a home exercise program is the more efficient approach to reduce pain and increase functional capacity, quality of life and general health condition. to do so, 60 participants with chronic cervical pain, will be recruited and divided into 3 groups according to the intervention they will receive: control group, experimental group 1 who will receive preventive chiropractic care in the form of spinal manipulations and experimental group 2 will have to perform an individualized home exercise program on a daily basis. we hypothesize that a group of patient receiving smt + a home exercise program will present less pain and functional disabilities over a 1 year period. the innovative value of this project is mainly related to the fact that it will generate new and potentially very useful data concerning the clinical significance of preventive chiropractic care. moreover, such data will be beneficial to our profession as chiropractic makes a step towards prevention, wellness and public health.


Eligibility criteria:
inclusion criteria: * adults between 18 and 60 years old from the city and the surrounding trois-rivières with chronic cervical pain of non-traumatic origin (chronic or recurrent cervical pain that lasted at least 6 months) exclusion criteria: exclusion criteria for the project are: * surgery to the cervical spine * neoplasms * severe osteoarthritis * ankylosing spondylitis * hypertension * referred pain in the cervical area * central or peripheric nervous system dysfunction * vascular disease * treated cardiovascular disease * inflammatory or infectious disease of the cervical spine * metabolic or endocrine diseases * pregnancy * specific rehabilitation training for the neck or already under manual therapy for neck pain * patient suffering from dizziness, vertigo or headache suspected to be cervicogenic or of unknown origin will not be involved in the study.