Kornimate/medical-research-clean huggingface dataset:
the effect of the treatment program "dr. fedon lindbergs vektcoach" on body weight and composition and hormonal profile

Conditions: Overweight; Obesity; Metabolic Syndrome

Summary: the background for the trial is a number of previous studies indicating that it is especially important to restrict the intake of carbohydrates when treating overweight and metabolic diseases in general. the purpose of the study is to obtain research data on the effects of an established treatment of overweight/obesity and its related metabolic disorders. the treatment, "dr. fedon lindbergs vektcoach", is a combination treatment where patients use low carbohydrate and low energy "eurodiet" products in the initial phases. after the initial phases are completed, low glycemic normal foods are added to the diet until a sustainable and healthy diet is achieved. the treatment is of 7 month duration.


Eligibility criteria:
inclusion criteria: * body mass index (bmi)\>35 * bmi\>27 + one risk factor for cardiovascular disease or metabolic syndrome * \>18 years exclusion criteria: * medicinal treatment of thyroid disease * pregnancy or planned pregnancy * taking of diet pills like xenical or sibutramine

Keywords: overweight obesity metabolic syndrome diet carbohydrate low glycemic index eurodiet
a study of imlunestrant, investigator's choice of endocrine therapy, and imlunestrant plus abemaciclib in participants with er+, her2- advanced breast cancer

Conditions: Breast Neoplasms; Neoplasm Metastasis

Summary: the main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy, and how well imlunestrant with abemaciclib work compared to imlunestrant in participants with breast cancer that is estrogen receptor positive (er+) and human epidermal receptor 2 negative (her2-). participants must have breast cancer that is advanced or has spread to another part of the body. study participation could last up to 5 years.


Eligibility criteria:
inclusion criteria: * have a diagnosis of er+, her2- locally advanced or metastatic breast cancer * have disease that has demonstrated progression on or after an aromatase inhibitor alone or in combination with a cyclin-dependent kinase (cdk)4/6 inhibitor -- participants are expected to have received prior treatment with a cdk4/6 inhibitor, if this treatment is approved and can be reimbursed * must be deemed appropriate for treatment with endocrine therapy * if female, have a postmenopausal status by natural or surgical means or by ovarian function suppression * have recist evaluable disease (measurable disease and/or nonmeasurable bone-only disease) * have a performance status of 0 or 1 on the eastern cooperative oncology group scale (oken et al. 1982) * have adequate renal, hematologic, and hepatic organ function * must be able to swallow capsules/tablets exclusion criteria: * have received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, or any investigational-er-directed therapy (including serds and non-serds), any pi3k-, mtor- or akt- inhibitor * have visceral crisis, lymphangitic spread within the lung, or any evidence of leptomeningeal disease. * have symptomatic or untreated brain metastasis. * have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study * known allergic reaction against any of the components of the study treatment

Keywords: serd
impact of the sustained viral response of chronic hepatitis c after treatment with direct action antivirals

Conditions: Hepatitis C, Chronic

Summary: the purpose of this study is to evaluate the evolution of liver injury with fibrosis data obtained using non-invasive serological markers in patients who achieved svr after treatment with direct-acting antivirals.

this open study includes patients with chronic hepatitis c who received treatment with the new direct-acting antivirals between november 1, 2014 and december 31, 2017, who achieved a sustained viral response at week 12.

Eligibility criteria:
inclusion criteria: * patients with chronic liver disease caused by virus c. * have received treatment with the new daas between november 1, 2014 and december 1, 2017. * patients diagnosed with advanced fibrosis and liver cirrhosis. advanced fibrosis was defined as a fibroscan\> 10 kpa, an apri index\> 1.5 and / or a fib-4 index\> 3.25. for its part, cirrhosis was defined such as a fibroscan\> 12.5 kpa and / or presence of esophagogastric varices in the endoscopic study and / or data portal hypertension ultrasound. exclusion criteria: * coinfection by virus b or hiv. * development of hcc before or during treatment. * abuse of alcohol intake or addiction to parenteral drugs. * liver disease of non-viral etiology (autoimmune, toxic, metabolic).
anodal transcranial direct current stimulation over the contralesional hemisphere on motor recovery in subacute stroke patients

Conditions: Stroke; Transcranial Direct Current Stimulation; Recovery of Function; Neurological Rehabilitation

Summary: upper limb recovery is not predicted by the initial severity of paralysis and the parameters reflecting the integrity of the corticospinal tract (e.g. motor evoked potential, fractional anisotropy in diffusion tensor imaging). although the inhibition of the contralesional hemisphere is known to be beneficial for the upper limb recovery after stroke in previous studies, this is not proven in the severely paralyzed upper limb. and the studies using the noninvasive stimulation in subacute stroke is lack. in addition, the role of contralesional (unaffected) hemisphere is known to be playing the important role in severe stroke. in this randomized, double-blind, sham-controlled studies, the patients with subacute stroke (\<3 months after stroke onset), severe paralysis of the upper limb with poor prognosis (poor motor score and no response of motor evoked potential recorded in the extensor carpi radialis muscle) will be recruited. interventional group will receive the 25 mins of anodal transcranial direct current stimulation (tdcs) over the contralesional premotor area plus 25 mins of robotic arm training per session for 10 sessions in 2 weeks. control group will receive the same treatment except for sham tdcs instead of anodal tdcs over the contralesional premotor area. functional outcome will be measured before and after the intervention (baseline, immediately after the intervention and 1 month after the intervention). cortical activation pattern will be measured by the electroencephalography (eeg) at baseline and immediately after the intervention.


Eligibility criteria:
inclusion criteria: * age: 18-85 years old * ischemic or hemorrhagic stroke confirmed by the mri or ct * first-ever stroke * \< 3 months after stroke * unilateral upper limb weakness due to the stroke and meets the following all conditions: (1)shoulder abduction finger extension (safe) score (range 0-10) revealing the motor paralysis is below 8 (lower score mean worse function)), (2)fugl meyer assessment score in the affected upper extremity is 25 or under 25. (3)no response in the motor evoked potential recorded on the affected extensor carpi radialis muscle, exclusion criteria: * recurrent stroke * history of the other brain injury (e.g. traumatic brain injury) * poor cognitive function (score of korean version of mini-mental state exam is 15 or below 15). * poor cooperation due to delirium or problems in the consciousness * uncontrolled or unstable medical conditions. * pregnant * scalp problems which interfere with the tdcs application * robotic arm training can not be applied due to the unstable sitting posture or head control, or arm pain. * metals in the head (e.g. clip, coil) * cardiac pacemaker or cochlear implants
effect of wearing face masks on salivary parameters and halitosis

Conditions: Dry Mouth; Halitosis

Summary: during the current covid-19 pandemic, the use of face masks is recommended / mandatory to prevent infection. patients and students have reported to experience limitations in their oral health-related quality of life, especially with regard to the occurrence of dry mouth and halitosis, while wearing face masks. scientific studies regarding the effects of face masks have so far focused exclusively on medical staff. studies among the general population are not yet available, but are of interest as dry mouth is a risk factor for dental diseases (e.g., caries, erosion). therefore, the present study aims at measuring the effect of wearing different face masks on salivary parameters (unstimulated and stimulated saliva flow rate, ph, buffer capacity) and halitosis (volatile sulphur compounds).


Eligibility criteria:
inclusion criteria: * oral healthy adult volunteers who are able to give written consent exclusion criteria: * non-fulfillment of the inclusion criteria * denied access to the university medical center goettingen at the corona screening * exemption from wearing a face mask for medical reasons * medical reasons hindering participants from refraining eating and drinking prior (except for water) or during the visits * hyposalivation / xerostomia (unstimulated saliva \< 0.3 ml/min, stimulated saliva \< 0.7 ml/min) * refusal to use fluoridated toothpastes * smoking
interest of measuring lung elasticity elastography in the fetus in the case of premature childbirth threat

Conditions: Pregnancy Complications; Obstetric Labor, Premature

Summary: the objective of the study was to evaluated the feasibility and reproducibility of the measurement of lung elasticity report / fetal liver according to gestational age in a group of patients with a normal course of pregnancy and in a group of patients at risk of preterm delivery.


Eligibility criteria:
inclusion criteria for control group : * major pregnant women * singleton pregnancy inclusion criteria for control group : * major pregnant women * singleton pregnancy * hospitalized for threatened premature birth between 24 and 34 wa * indication of a cure corticosteroid betamethasone exclusion criteria: * maternal conditions of pregnancy: diabetes gestational, pregnancy-induced hypertension, preeclampsia * fetal lung diseases

Keywords: elastography
effect of enzyme therapy on protein metabolism in chronic pancreatitis

Conditions: Pancreatitis

Summary: pancreatic exocrine insufficiency is known to impair nutrient absorption, especially fat, but few data exist about protein absorption. we aimed to investigate this question and assess the enzyme substitution efficiency using a sensitive method.


Eligibility criteria:
inclusion criteria: * chronic pancreatitis * pancreatic insufficiency * enzyme therapy treatment exclusion criteria: * hepatic failure * pregnancy * positive serology to hiv, hcv, aghbs, gastro-intestinal disease

Keywords: protein absorption in pancreatitis protein metabolism in pancreatitis
study in adult and adolescent subjects with seasonal allergic rhinitis (sar)

Conditions: Seasonal Allergic Rhinitis; Hay Fever

Summary: the purpose of the study is to assess the efficacy and safety of an investigational nasal aerosol compared with placebo nasal aerosol in the treatment of seasonal allergic rhinitis.


Eligibility criteria:
inclusion criteria: * informed consent * male or female subjects 12 years of age or older * documented history of season allergic rhinitis to mountain cedar pollen * general good health * other criteria apply exclusion criteria: * history of physical findings of nasal pathology (within 60 days prior to screening visit) * participation in any investigational drug study 30 days preceding screening visit * history of respiratory infection/disorder with 14 days preceding screening visit * use of any prohibited concomitant medications * other criteria apply
effects of sertraline on brain connectivity in adolescents with ocd

Conditions: OCD

Summary: the investigators will examine how treatment with sertraline for 12 weeks impacts frontal-striatal-thalamic circuitry (fstc) in this ocd sample.

to examine fstc using advanced multi-modal imaging techniques, including resting-state functional magnetic resonance imaging (r-fmri) and high angular resolution diffusion imaging (hardi), in 25 medication-free adolescents youths with ocd (ages 8-17) in comparison with 25 matched healthy controls. hypotheses: (a) based on the pilot data, adolescents youths with ocd will show lower functional connectivity in fstc at baseline when compared with controls, and , lower functional connectivity in fstc will correlate with greater severity on cy-bocs. (b) adolescents youths with ocd will also show abnormalities in structural connectivity in fstc at baseline when compared with controls, and structural and functional connectivity will be related. (c) the investigators will explore relations between ocd dimensions and functional connectivity measures, and predict that the repeating/ordering dimension will correlate with orbitofrontal cortex (ofc) connections, hoarding will correlate with rostral anterior cingulate cortex (acc) connections, and forbidden thoughts will correlate with caudal acc connections. to investigate how sertraline impacts functional connectivity in fstc in adolescents with ocd. hypothesis: after 12 weeks of sertraline treatment, functional connectivity measures within fstc for the ocd group will (on average) increase compared to baseline and will no longer be significantly different when compared with controls. non-responders may show a different pattern (i.e. failure to show these changes).

Eligibility criteria:
inclusion criteria (ocd): * ocd as the primary diagnostic and statistical manual of mental disorders, 4th edition (dsm-iv) diagnosis based on the anxiety disorders interview schedule (adis) for dsm-iv, child version * children's yale-brown obsessive compulsive scale (cy-bocs) score of greater than 15 exclusion criteria (ocd): * lifetime diagnosis of bipolar disorder, schizophrenia, or substance abuse/dependence on adis * intelligence quotient (iq) \< 80 on wechsler abbreviated scales of intelligence (wasi) * positive urine drug screen * mri-incompatible features (e.g., metal implants, claustrophobia) * current or recent trial of psychotropic medication (within the past 4 8 weeks or past 6 12 weeks for fluoxetine) * non-response in \> 2 selective serotonin reuptake inhibitor (ssri) trials of adequate dose/duration * positive pregnancy test * history of seizure disorder or serious head injury inclusion criteria (controls): * healthy 8-17 year olds exclusion criteria (controls): * no psychiatric diagnoses * no immediate family history of ocd

Keywords: ocd
application of integrated proteomic and serum metabolomic analysis in assessing the efficacy and prognosis of tace combined with targeted immunotherapy in unresectable hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: application of integrated proteomic and serum metabolomic analysis in efficacy and prognosis assessment: a multi-omics analysis based on gut microbiota to evaluate the predictive value of microbial-derived proteins and metabolites on treatment efficacy and patient outcomes, developing non-invasive tools for treatment monitoring and prognostic prediction.

this study is a prospective, observational study based on real-world data. it prospectively and continuously collects data from patients with unresectable hepatocellular carcinoma who have received tace combined with targeted and immunotherapy as part of their routine diagnostic and treatment procedures. patients are grouped based on treatment efficacy, and integrated proteomic and serum metabolomic analyses are conducted on samples before and during treatment to obtain clinical evidence from the real world.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * histologically or clinically diagnosed with hepatocellular carcinoma (hcc). * classified as bclc stage b/c, not suitable for surgical resection or liver transplantation. * planned or already receiving tace combined with tiragolumab and first-line targeted therapy for liver cancer. * not participating in other clinical studies. * able to obtain imaging evaluation data and other clinical records during treatment. exclusion criteria: * known fibrolamellar hcc, sarcomatoid hcc, or mixed hepatocellular-cholangiocarcinoma histology. * tumors involving the main portal vein or inferior vena cava. * use of antibiotics within one month before treatment. * history of other malignancies.
adaptive radiotherapy for head and neck cancer

Conditions: Head and Neck Cancer; Paranasal Sinus Cancer; Oropharynx Cancer; Oral Cavity Cancer; Nasopharynx Cancer; Larynx Cancer; Hypopharynx Cancer

Summary: the purpose of this study is to demonstrate that adaptive radiotherapy (art) in head and neck cancer patients are comparable to historical controls in head and neck patients undergoing standard intensity-modulated radiation therapy (imrt) without art.


Eligibility criteria:
inclusion criteria: * participants with pathologically confirmed cancers of paranasal sinuses, oropharynx, oral cavity, nasopharynx, larynx, hypopharynx, and unknown primary and will receive definitive radiation therapy with or without chemotherapy. * karnofsky performance status \>= 70% * women of childbearing potential need to have a negative serum pregnancy test at the time of therapy * participants must have the ability to understand and the willingness to sign a written consent form exclusion criteria: * female participants who are pregnant or breast feeding * participants who are not able to comply with study and/or follow up procedures * participants who have received induction chemotherapy before radiation treatment * participants who had prior head and neck radiation therapy * participants who are enrolled in a national/international cooperative group trials * patients with metastatic disease

Keywords: adaptive radiotherapy art intensity modulated radiation therapy imrt
dcbti for adults with adhd

Conditions: Insomnia

Summary: the current study aims to evaluate the efficacy and feasibility of a digital application-based cbti treatment devised for adults with adhd and insomnia compared to self-monitoring and sleep hygiene control condition.

participants would be randomly assigned to the experimental or sleep diary self-monitoring (control) group. participants in the experimental group would use a digital application for seven weeks, whereas participants in the control group would watch psychoeducation videos on sleep hygiene and enter sleep diary measures using the application for seven weeks. question 1: does dcbti work better than the active control? hypothesis 1: improvement in insomnia (immediately after treatment and at 1-month follow-up) would be greater for the experimental group than the active control group. question 2: does improvement in insomnia due to dcbti lead to improvement in adhd outcomes? hypothesis 2: improvement in adhd outcomes would be greater for the experimental group than the active control group. the effect of dcbti on adhd outcomes would be mediated by improvement in insomnia. question 3: does improvement in insomnia due to dcbti lead to improvement in mental well-being? hypothesis 3: improvement in outcomes related to mental well-being would be greater for the experimental group than the active control group. the effect of dcbti on outcomes related to mental well-being would be mediated by improvement in insomnia.

Eligibility criteria:
inclusion criteria: * (a) hong kong resident, * (b) aged between 18-60, * (c) diagnosed with adhd, * (d) able to read and write chinese, * (e) has regular access to a smart phone and internet, * (f) insomnia severity index ⩾10 exclusion criteria: * (a) having comorbid bipolar disorder, psychosis, suicidality, moderately severe to severe depression, narcolepsy, and/or hypersomnolence disorder, * (b) having medical conditions that might affect sleep (e.g., serious physical concerns necessitating surgery, risk of falls, epilepsy), * (c) having night shift schedules at work, * (d) currently receiving psychological intervention for insomnia

Keywords: digital intervention cognitive behavioral therapy for insomnia treatment efficacy treatment adherence
a study of tmc435 in combination with pegylated interferon alp\fa-2a and ribavirin in patients infected with genotype 1 hepatitis c virus who never received treatment

Conditions: Hepatitis C

Summary: the purpose of this study is to evaluate the efficacy of 4 different regimens of tmc435 in combination with peginterferon alfa-2a (pegifnα-2a) and ribavirin (rbv), defined as the proportion of patients with sustained virologic response at week 72 (patients with undetectable plasma hcv rna \[less than 25 iu per ml undetectable\] at the end of treatment and at week 72), compared to the control group receiving pegifn and rbv in combination with tmc435-matched placebo.

this is a randomized (study medication assigned by chance), 5-arm, double-blind (neither investigator nor the participant knows the treatment that the participant receives), placebo-controlled (an inactive substance that is compared with the study medication to test whether the study medication has a real effect in clinical study) study to compare the efficacy, tolerability and safety of different tmc435 regimens combined with peginterferon alfa-2a (pegifnα-2a) and ribavirin (rbv) versus pegifnα-2a plus rbv alone in adult treatment-naive patients with chronic genotype 1 hcv infection. the study mainly consists of 3 phases: screening phase (approximately 6 weeks), treatment phase (up to 48 weeks), and follow up phase (up to 48 weeks). in the treatment phase, patients will be divided in to 5 different arms in a 1:1:1:1:1 randomized ratio. in treatment arms 1 and 2, patients will receive 12 weeks of therapy with tmc435 along with pegifnα 2a and rbv followed by treatment with pegifnα 2a, rbv, and tmc435-matched placebo. in treatment arms 3 and 4, patients will receive 24 weeks of therapy with tmc435, pegifnα 2a, and rbv. in treatment arm 5 (control group), patients will receive pegifnα 2a and rbv for 48 weeks and tmc435 matched placebo for the first 24 weeks. collection of blood samples for efficacy evaluations will be done at scheduled visits throughout the study. safety evaluations for adverse events, clinical laboratory tests, physical examination, vital signs and electrocardiogram will be monitored throughout the study. the total duration of the study will be up to approximately 72 weeks after initiation of treatment.

Eligibility criteria:
inclusion criteria: * patients with documented chronic genotype-1 hepatitis c infection and with plasma hcv rna of \> 100,000 iu/ml at screening * patients that have not been treated before for hcv * patients that are of childbearing potential or have a partner of childbearing potential should agree to use 2 effective methods of contraception exclusion criteria: * patients with cirrhosis or evidence of hepatic decompensation * co-infection with the human immunodeficiency virus (hiv) * any contraindication to pegasys or copegus therapy * history of, or any current medical condition which could impact the safety of the patient in the study

Keywords: hepatitis c tmc435 peginterferon alpha-2a pegifnalpha-2a rbv ribavirin placebo