Kornimate/medical-research-clean huggingface dataset:
short-term effects of combined manual therapy to the cervical and thoracic spine

Conditions: Neck Pain

Summary: neck pain continues to be a prevalent condition in our society. manual therapy (hands on techniques for the treatment of neck pain is an intervention commonly implemented in clinical practice. recently researchers and clinicians have implemented manual therapy techniques to the thoracic spine (midback) to treat patients with neck pain. to date no studies have examined the short-term combined effects of thoracic spine manual therapy and cervical spine manual therapy in the treatment of patients with mechanical neck pain. the purpose this study is to assess the combined effects of thoracic spine thrust manipulation with cervical spine non-thrust manipulation in patients with neck pain.


Eligibility criteria:
inclusion criteria: * neck pain of less than 3 months * no symptoms below the shoulder * baseline neck disability index score of 10 or greater exclusion criteria: * red flags noted in the patient's medical screening questionnaire (i.e. tumor, fracture, metabolic disease, rheumatoid arthritis, osteoporosis, prolonged use of steroid, etc) * history of whiplash injury within the past two months * diagnosis of cervical spinal stenosis * uni-lateral or bi-lateral upper extremity radicular symptoms * evidence of central nervous system involvement * two or more positive neurological signs consistent with nerve root involvement: myotomal muscle weakness, dermatomal sensory loss, diminished or absent reflexes * prior surgery to the neck or thoracic spine * pending legal action regarding their neck pain, or patients with no fault or workers compensation claims * insufficient english language skills to complete the questionnaires * inability to comply with treatment and follow-up schedule * women who may be pregnant

Keywords: neck pain thrust manipulation non-thrust manipulation
international multicenter study on lipin-1 deficiency

Conditions: Lipin-1 Deficiency

Summary: lipin1 is an international registry that allows the collection of data on the follow-up, management and treatment of patients with lipin-1 deficiency.

this study evaluates survival, cardiac function, quality of life, fatigability, treatment tolerance and comparison of the efficacy of different current treatments in patients with lipin-1 deficiency.

Eligibility criteria:
inclusion criteria: patient at least 12 months with lipin1 deficiency confirmed by molecular biology (two causal mutations in the lpin1 gene) exclusion criteria: opposition of the patient or his parents to participate to the study

Keywords: inherited metabolic diseases enzymatic deficiency rhabdomyolysis
safety and efficacy of pegteograstim in korean breast cancer patients

Conditions: Breast Cancer

Summary: this is a prospective, single arm study, which is examining doxorubicin and cyclophosphamide (ac) once every 2 weeks with pegteograstim support in korean early breast cancer.

pegteograstim is a novel monopegylated recombinant human g-csf. in this prospective study, the incidence of febrile neutropenia during four cycles of dose dense (dd) doxorubicin/cyclophosphamide (ac) with pegtoegrastim support is being investigated. the primary objective of this study is to determine the incidence of febrile neutropenia during four cycles of dd ac with pegteograstim support (8 weeks). patients received four cycles of dd-ac (60 mg/m² doxorubicin and 600 mg/m² cyclophosphamide administered intravenously on day 1 every two weeks). a fixed dose of 6.0 mg pegteograstim was administered subcutaneously on day 2 of each chemotherapy cycle (between 22 and 26 hours after the completion of chemotherapy). clinical, hematological, and biochemical assessments were done before the start of each cycle. adverse events (aes) were graded using the national cancer institute common toxicity criteria (nci-ctcae version 4.03).

Eligibility criteria:
inclusion criteria: * histological or cytological diagnosis of a primary breast cancer (stage i-iii) * age \> 18 years of age and age \< 66 years of age * eastern cooperative oncology group (ecog) performance status score 0 - 1 * patients who have plan to receive neoadjuvant or adjuvant dose-dense ac chemotherapy * adequate organ functions 1. anc ≥1500 cells/mm3 2. plt ≥100,000 cells/mm3 3. ccr ≥50 ml/min, or serum cr \<1.5 x (upper limit of normal, uln) 4. total bilirubin ≤1.5 x uln 5. ast (sgot) ≤2.5 x uln 6. alt (sgpt) ≤2.5 x uln exclusion criteria: * previous chemotherapy history * previous bone marrow transplantation history * sickle cell anemia * radiation therapy within 4 weeks from enrollment * previous pegfilgrastim, filgrastim or other colony-stimulating factor treatment within 4 weeks from enrollment * clinically significant systemic illness (serious infection, liver, kidney, heart disease) * pregnant, breast feeding women

Keywords: breast cancer dose-dense chemotherapy pegfilgrastim
nails and teeth as biomarkers of fluoride exposure

Conditions: Fluorosis, Dental

Summary: to determine fluoride concentration in fingernails and estimate if there is a correlation between fluoride concentration in fingernails and fluoride concentration in toothpaste used. in addition, fluorosis of permanent incisors will be evaluated at 13 years of age and correlated with toothpaste fluoride concentration.

toothpaste with 1000 ppm fluoride and above are more effective in a caries prevention in comparison to toothpastes with lower fluoride concentration or to placebo. higher fluoride concentrations in toothpastes increase risk for development of tooth fluorosis. children in first three years of life are most susceptible due to formation of permanent incisors and first molars in this period, beside younger children ingest more toothpaste compared to older children. fluoride exposure can be measured in nails, where the average plasma fluoride concentration is reflected. the aim of our study was to determine fluoride concentration in fingernails and estimate if there is a correlation between fluoride concentration in fingernails and fluoride concentration in toothpaste used. in our study were included parents and children who had participated in previous studies from parenting class until children's 3 years of age. at that time children were randomly assigned to one of two groups, of which one was being given a toothpaste with 500 ppm fluoride and the other with 1000 ppm fluoride. children were examined regularly until the age of 3. children were invited to participate in another clinical examination at 4 years of age. at the time of examination parents were asked to fulfil a questionnaire about oral hygiene habits and a sample of children's fingernails were taken. a questionnaire fulfilled 200 parents, 169 children were examined, finger nail fluoride was analysed by using a gas chromatography method in 161 children. we determined that in 76 % the toothpaste chosen was not appropriate according to eapd guidelines, 66 % parents was using toothpaste with 500 ppm fluoride for their children. the mean fingernail concentration was 1,43 ng/mg (sd = 0,08). the difference between groups using toothpastes with different fluoride concentrations, and compared with other factors, was not statistically significant. the mean concentration of fluoride in nails of our test group was low compared to reported values in similar studies and there was no significant difference between groups regarding to toothpaste used. in addition, fluorosis of permanent incisors will be evaluated at 13 years of age and correlated with toothpaste fluoride concentration.

Eligibility criteria:
inclusion criteria: * participation in parenting class * normal pregnancy exclusion criteria: * chronic systemic diseases * genetic conditions * complications at delivery

Keywords: dental fluorosis fingernails fluoride concentration fluoride toothpaste concentration
goal directed versus conventional weight loss program

Conditions: Obesity

Summary: the aim of our study is to determine if the goal directed weight loss program improves weight loss versus the conventional weight loss program after laparoscopic sleeve gastrectomy.

the aim of our study is to determine if a goal directed program improves weight loss outcomes after sleeve gastrectomy. bariatric patients are managed by a multidisciplinary team comprising of bariatric surgeons, dieticians, physiotherapists, and physicians. in the conventional weight loss program, patients were only given their ideal weight to strive toward after surgery. previous patients undergoing bariatric surgery in the standard program often enquired about the expected excessive weight loss targets after bariatric surgery. this patient driven need led to the development of the goal directed weight loss program. this modified program involves a component of behavioural intervention. bariatric patients in this modified program will be counselled prior to lsg and ewl targets will be set for patients to achieve at fixed intervals post lsg. these targets are charted on a graph, with the patient's actual weight charted on the same graph at each clinic consultation, providing a strong visual aid to counseling and motivation. the aim of the study is to recruit 120 patients undergoing laparoscopic sleeve gastrectomy. these patients will be randomized to either the goal directed program or a standard program. patient demographics, preoperative weight, and post operative weights at 3, 6, 9, 12, 18 and 24 months post laparoscopic sleeve gastrectomy will be collected. univariate and multivariate analyses will be performed between each group with excess weight loss being the primary endpoint. such a trial would allow evaluation to know if the effort spent in implementing a goal directed weight loss program translates to improved weight loss outcomes in bariatric surgery patients. there are no significant risks involved in implementing such a program for our patients. this is based on a retrospective review of patients who have undergone the goal directed program in nuh. if such a program is shown to improve weight loss outcomes post surgery, it could potentially be adopted by bariatric centers worldwide. if the goal directed program is shown to have no bearing on weight loss outcomes, the extra efforts by the bariatric team into implementing such a program could be better directed to other endeavours.

Eligibility criteria:
inclusion criteria: 1. patients having met the indications for laparoscopic sleevel gastrectomy, determined preoperatively by the attending surgeon 2. age \>21 or \<65 3. bmi \>32.5 and \<45 4. mentally sound 5. agreeable to commit to the length of follow up 6. agreeable for randomization and signed consent form exclusion criteria: 1. no signed consent form 2. age \ 65 3. bmi \ 45 4. previous bariatric surgery 5. mentally unsound 6. unable to commit to follow up schedule 7. pregnant women or women who are breast-feeding
a study of istradefylline (kw-6002) in treating patients with parkinson's disease on levodopa

Conditions: Parkinson's Disease

Summary: to establish the efficacy of 10, 20 and 40 mg/d dose of istradefylline for reducing the percentage of off time in patients with advanced parkinson's disease (pd) treated with levodopa.

to establish the efficacy of 10, 20 and 40 mg/d dose of istradefylline for reducing the percentage of off time in patients with advanced parkinson's disease (pd) treated with levodopa. patients who meet entry criteria will be randomized in a 1 to 1 ratio to either istradefylline 10, 20 or 40 mg or matching placebo. patients will be treated for 12 weeks and will have interim visits and end of treatment visit to assess efficacy and safety.

Eligibility criteria:
inclusion criteria: 1. uk parkinson's disease society (ukpds) brain bank criteria (step 1 and 2) for pd. 2. pd stages 2-4 in the off state for modified hoehn and yahr scale. 3. on levodopa/carbidopa for at least one year, stable dose in past 4 weeks. 4. currently take at least three doses of levodopa/carbidopa per day. 5. predictable end of dose wearing off. 6. able to satisfactorily complete hauser version of a parkinson's diary. 7. have an average of 180 minutes of off time on two 24 hour diaries. 8. be at least 30 years of age. exclusion criteria: 1. neurosurgical treatment for pd. 2. history of psychosis. 3. diagnosis of atypical parkinsonism, secondary parkinsonism variant or parkinson's plus syndromes. 4. diagnosis of cancer within 5 years. 5. mini-mental status examination score of 25 or less. 6. history of seizures or neurologic malignant_syndrome.

Keywords: levodopa end of dose wearing off off time
a clinical research studying a method of intervention for children diagnosed with anxiety disorder: attentional bias intervention

Conditions: Anxiety

Summary: studies show that children with high levels of anxiety tend to pay more attention to threatening stimulus in the environment. they tend to attend to these stimuli and have difficulty to disengage from them. these attention biases enhance and maintain the level of anxiety. the aim of this study is to test a method of therapeutically intervention which focuses on shifting these attentional biases, with the use of a computer game which was designed to train the child to focus his/her attention away from the threatening stimuli and to focus on natural or positive stimuli. we will recruit 160 children with ongoing anxiety disorders who seek treatment. we will first assess threat-related attention bias and anxiety symptoms using structured psychiatric interviews and questionnaires. we will then randomly assign these children to one of four conditions: training to avoid threatening stimuli and attend to neutral stimuli; control placebo-training for threat-neutral stimuli; training to attend to positive stimuli and avoid neutral stimuli; and, control placebo-training for positive-neutral stimuli. upon completion of training we will again assess attention bias and anxiety. two sets of predictions will be tested, one set concerns the effects of training on attention, and the other concerns the effects of training on anxiety. in terms of training effects on attention, we hypothesize that children with anxiety disorders can be trained to either avoid threat or attend to positive stimuli. in terms of training effects on anxiety symptoms, we hypothesize that the experimental training sessions will produce greater reduction in symptoms of anxiety than the placebo-control training sessions.


Eligibility criteria:
inclusion criteria: * children with clinical diagnosis of generalized anxiety disorder (gad), social phobia (sp), or separation anxiety disorder (sad). exclusion criteria: * children with the diagnoses of ocd, specific phobia, and ptsd in the absence of comorbid gad, sp, or sad. * other exclusion criteria include ongoing major depressive disorder, and use of psychotropic medication.

Keywords: anxiety attention-biases children
transvaginal versus transabdominal extraction of laparoscopically-excised kidney specimen

Conditions: Urologic Neoplasms

Summary: the aim of this study is to evaluate the outcomes of transvaginal natural orifice specimen extraction (nose) in patients who are planning multiport laparoscopic surgery for resection of kidney.

study design: this is a prospective, randomized, single center trial. this clinical trial was approved by the institutional review boards. study process: all patients gave informed written consent after being informed of the details of the study. subjects were randomized into either the experimental group (specimen removal through posterior vagina fornix incision) or control groups (specimen removal through extended abdominal incision). all participants underwent demographic and history taking, laboratory tests, a gynecologic examination to determine whether specimen removal through vagina is possible. to evaluate cosmesis, patient satisfaction and quality of life vas (visual analogue scale), sf-12 (short form-12) health survey, biq (body image questionnaire) and posas (the patient and observer scar assessment scale) will be sent to the patients 6 months after the surgery.

Eligibility criteria:
inclusion criteria: * patients who are accessible with vaginal approach * patients scheduled for laparoscopic resection of kidney for benign or malignant diseases * patients with normal cervical cancer screening tests within the last 3 years except inflammatory findings exclusion criteria: * patients without sexual intercourse * patients who are considered unable to remove specimen through vagina due to narrow introitus in gynecological examination * patients who are expected to have severe adhesion due to deep infiltrative endometriosis or previous pelvic surgery history * patients with abnormal cervical cancer screening tests * patients scheduled to perform concomitant hysterectomy

Keywords: natural orifice specimen extraction laparoscopic surgery transvaginal female
skin imaging with technologies in development

Conditions: Pigmented Skin Lesion of Uncertain Nature

Summary: the purpose of this research is to develop non-invasive imaging modalities for assessment of skin. this is a pilot study which will use multiple imaging modalities to collect information on normal and lesional skin. the researchers understand that the purpose of this study is not to evaluate any particular treatment and an investigation of a new therapeutic intervention would require an additional protocol. skin conditions to be studied include vascular lesions, pigmentary disorders, inflammatory conditions and neoplasms.

normal and lesional skin will be assessed by the following imaging modalities: 1. laser speckle imaging can provide information about relative blood flow in a tissue. in skin it can be used to determine what areas have more blood flow and whether a particular intervention or treatment affects blood flow. 2. optical coherence tomography and optical doppler tomography can provide pictures of blood vessels in an area of the body and can also tell how fast blood is flowing in that area. 3. photon migration spectroscopy can provide information about the amount of blood, oxygen, fat and water is in a tissue. 4. multi-spectral imaging can provide a 3 dimensional image of structures within the skin. 5. multiphoton microscopy can provide images of structures of the skin.

Eligibility criteria:
inclusion criteria: * adult male or female 7 and older; able to carry out study instructions exclusion criteria: * younger than 7 years old * pregnant woman * breast feeding

Keywords: human skin
paracetamol effect on prostaglandins and blood pressure

Conditions: Pain

Summary: this research program aims to investigate the influence of paracetamol on blood pressure and the cyclooxygenase (cox) - prostaglandine (pg) pathway in patients with pain. through an observational pilot study, we will use advanced lc/esi-ms/ms methodology to analyze the cox-og pathway in plasma and urine. the study will assess the effects of paracetamol compared to ibuprofen, considering different types of pain. the primary focus is to understand the changes in blood pressure and the cox-pg pathway upon initiation or discontinuation of paracetamol, with safety analysis as a secondary consideration.


Eligibility criteria:
inclusion criteria: * headache and orosurgical patients treated at the respective charite outpatient clinic. * age 18 years or older * able to consent * patients with migraine type headache treated with paracetamol or ibuprofen within the last 12 hours or not treated with paracetamol or ibuprofen within the last 48 hours * patients treated with with paracetamol or ibuprofen undergoing orosurgery for wisedome tooth extraction exclusion criteria: * pregnancy * arterial hypertension * use of beta blockers * use of cox inhibitors other than paracetamol or ibuprofen, including low-dose acetylsalicylic acid * stable prophylactic therapy of migraine for less than 3 weeks * use of tryptans in the last two days (frovatriptane in the last 6 days) * oral surgery patients using paracetamol or ibuprofen in the last 24 hours * known allergy to paracetamol or ibuprofen
optical coherence tomography (oct) evaluation of re-endothelization: a comparison of the intrepide™ stent versus taxus™

Conditions: Coronary Artery Disease; Acute Coronary Syndrome

Summary: patients presenting with acs (acute coronary syndrome) in the emergency department will be screened for clinical eligibility and asked to sign informed consent to the study. a total of 40 patients will be randomized. 20 of them will receive a trapidil eluting stent (intrepide™ stent), 20 will receive a paclitaxel eluting stent (taxus™ stent). after 90 days the patients who were treated with the intrepide stent in the first lesion will be treated with the taxus stent in the second lesion. after 90 days the patients who were treated with the taxus stent in the first lesion will be treated with the intrepide stent in the second lesion. coronary angiography will be performed through the femoral (groin) or radial (wrist) artery with the use of standard techniques. the doctor will determine if the patient is qualified for enrolment at the end of the diagnostic coronary angiogram


Eligibility criteria:
inclusion criteria: clinical * \>18 years of age, * symptoms of non st-elevation acs (defined by the acc/aha criteria) for 30 min but \<48 h * patient must provide written informed consent prior to the procedure using a form that is approved by the local institutional review board angiographic * reference vessel diameter of culprit/target lesion between 2.25 to 3.5 mm (visual estimate) * discrete target lesion (maximum length of 28 mm by visual estimation) * target lesion is in a native coronary artery * presence of another lesion more than 70% in a vessel different from the culprit one amenable of planned percutaneous treatment 90 days thereafter. exclusion criteria: clinical * previously documented left ventricular ejection fraction of less than 30% * estimated life expectancy of less than 12 months * a history of bleeding diathesis, leukopenia, thrombocytopenia, or severe hepatic or renal dysfunction * participation in another study * inability to give informed consent owing to prolonged cardiopulmonary resuscitation * and dominant renal impairment (serum creatinine \> 2.0 mg/dl) angiographic * non-culprit lesion located in the proximal lad or in a proximal and dominant circumflex artery * previous pci of the target vessels restenosis or stent thrombosis as culprit lesion * unprotected left main coronary artery disease * non-culprit lesion located in a vein graft * severe multivessel disease (three major epicardial vessel disease) need of overlapping stenting for one lesion

Keywords: oct reendothelialisation intrepide trapidil taxus
a single dose trial of nnc 0155-0000-0004 in patients with haemophilia a

Conditions: Congenital Bleeding Disorder; Haemophilia A

Summary: this trial is conducted in asia and europe. the aim of the trial is to investigate the pharmacokinetics (the rate at which the trial drug is eliminated from the body) of a single dose of turoctocog alfa (nnc 0155-0000-0004 (n8)) in patients with haemophilia a. participation in this trial is dependent on previous participation in trial nn7008-3543 (part b) (nct00840086).


Eligibility criteria:
inclusion criteria: * subjects with the diagnosis of severe haemophilia a (factor viii less than or equal to 1%) * body weight between 10 to 120 kg * subjects who have completed nn7008-3543 (part b) or subjects participating in nn7008-3568 after completion of nn7008-3543 (nct00840086) exclusion criteria: * known or suspected hypersensitivity to trial product(s) or related products * previous participation in this trial defined as withdrawal * planned surgery during the trial period (catheter, stents, ports, and dental extractions do not count as surgeries and will not exclude the subject) * any disease or condition which, according to the trial physician's judgement, could imply a potential hazard to the subject, interfere with the trial participation or trial outcome