Kornimate/medical-research-clean huggingface dataset:
to determine the effects of deodorant, antiperspirant and washing on the pharmacokinetics of 2% testosterone md lotion

Conditions: Hypogonadism

Summary: testosterone replacement treatment is the most effective way of treating hypogonadism in men. acrux has a propriety testosterone replacement product, testosterone md-lotion and this study will evaluate the impact of application of antiperspirant and deodorant on absorption of testosterone, when applied pre-application of testosterone md-lotion® (cutaneous solution). the study also aim to evaluate the impact of washing the application site on the absorption of testosterone, when washed post-application of testosterone md-lotion® (cutaneous solution).


Eligibility criteria:
inclusion criteria: * healthy premenopausal female subjects ≥18 and ≤45 years of age with qualifying general medical health. exclusion criteria: * disqualifying concurrent condition or allergy/sensitivity to testosterone replacement therapy.
the efficiency of postoperative interferon-alpha treatment in p48 positive patients with hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: the purpose of the study is to determine whether interferon-alpha is effective in the treatment of p48 positive patients with hcc after curative resection.

background: postoperative interferon-alpha (ifn-alpha) therapy improved survival in patients with hepatocellular carcinoma (hcc). p48 is a predictive marker for outcome of postoperative interferon-alpha treatment in patients with hcc. our study is to identify the efficiency of postoperative ifn-alpha treatment in p48 positive patients with hcc. methods: an immunohistochemical study of p48 was performed on specimens that were collected from patients who underwent a curative resection of hcc. these patient with p48 positive were randomized divided into a treatment group who received postoperative ifn-alpha therapy and a comparison group who not received. besides the side effect, the overall survival rate and the disease-free survival rate will be observed. anticipated results: ifn alpha treatment improved the overall survival of p48 positive patients with hcc after curative resection, probably by postponing recurrence.

Eligibility criteria:
inclusion criteria: * patients with p48 positive who underwent a curative resection of hcc exclusion criteria: * none

Keywords: hepatocellular carcinoma interferon-alpha p48
third line antiretroviral treatment optimization in sub-saharan africa

Conditions: HIV Infection

Summary: thilao is a multi-country, phase 2b, non-randomized study, in burkina faso, cote d'ivoire, mali and senegal, west africa. hiv-1 adults with 2nd-line art virologic failure (plasma hiv-1 rna \>1000 copies/ml) will be recruited and followed in two phases: * first, a 12-week intentive adherence reinforcement phase, during which patients will continue 2nd-line art, be seen repeatidly for counseling and educational training on adherence, and be offered the possibility of phone, sms and home visit contacts with social workers; * second, a 48-week phase, during which: * patients successfully resuppressed at the end of the first phase will continue 2nd-line art and adherence reinforcement; * patients with persitent virologic failure will switch to a darunavir/r + raltegravir-based 3rd-line art. genotype resistance tests will be performed retrospectively on frozen samples. the main outcome will be the percentage of patients with plasma hiv-1 viral rna \<50 copies/ml at 64 weeks.

main objective to estimate, in sub-saharan african hiv-1 infected adults who failed a nnrti-base first-line art and then a pi-based second-line art: 1. the efficacy (and associated factors) at 12 weeks of an intensive 3-months adherence reinfrocement phase; 2. in patients who successfully resuppress at 12 weeks: the percentage of patients still with continuing succesfull virologic supression on 2nd-line art at 64 weeks (and factors associated to success) ; 3. in patients with persistent failure at 12 weeks : the efficacy (and associated factors) at 64 weeks of a darunavir/r + raltegravir-based 3rd-line regimen. number of participants : 200 main outcome : * at 12 weeks : proportion of patients with a plasma hiv-1 rna \ 2 log10 copies/ml between inclusion and 12 weeks; * at 64 weeks : proportion of patients with a plasma hiv-1 rna \<50 copies/ml. inclusion criteria: * age \>18 years * documented hiv-1 infection. * history of failing a nnrti-based 1st-line art * current pi-based 2nd-line art \>6 months * plasma hiv-1 rna \>1000 copies/ml * signed informed consent

Eligibility criteria:
inclusion criteria: * age \>18 years * documented hiv-1 infection * history of failing a nnrti-based 1st-line art * current pi-based 2nd-line art \>6 months * plasma hiv-1 rna \>1000 copies/ml * signed informed consent exclusion criteria: * hiv-2 infection * any severe clinical event under exploration * history of treatment including darunavir or raltegravir.

Keywords: africa antiretroviral treatment adherence reinforcement third line art second line art virologic failure adults
abortive treatment of migraine with the cefaly® abortive program device

Conditions: Migraine

Summary: the purpose of this study is to investigate the efficacy of the cefaly® abortive program device used at home for 2 hours to treat a migraine attack. this open clinical trial will study the abortive treatment of migraine using the cefaly® abortive program device, prior to development of a sham-controlled trial.

the main objective of this study is to have a pilot assessment of the efficacy of the cefaly® abortive program device used at home for 2 hours to treat a migraine attack, as triptans are generally used. that is to say having pilot data to assess the efficacy of the cefaly® abortive program device in the abortive treatment of acute migraine as measured by 2-hour pain freedom, pain relief and migraine associated symptoms freedom, plus evolution of these measurements for 24 hours after the beginning of the treatment session.

Eligibility criteria:
inclusion criteria: * age from 18 to 65 years on the day of signing the informed consent form * ≥ 1-year history of migraine with or without aura according to the diagnostic criteria listed in the international classification of headache disorders (ichd)-iii beta (2013) section 1, migraine (8), with the exception of aura without headache, hemiplegic migraine and brainstem aura migraine * migraine onset before the age of 50 years * having between 2 and 8 moderate or severe migraine attacks (grade 2 or 3) per month in each of the two months prior to screening * patient understands the study procedures, alternative treatments available, and voluntarily agrees to participate in the study by giving written informed consent * patient is able to read and understand the written information (instruction sheet, paper diary and adverse events (ae) collecting form) exclusion criteria: * patient has difficulty distinguishing his/her migraine attacks from tension-type headaches * patient has more than 15 headache days per month * patient having received supraorbital nerve blocks in the prior 4 months * patient having received botox treatment in the prior 4 months * modification of a migraine prophylaxis treatment in the previous 3 months * diagnosis of other primary headache disorders, except rare (\< 4) tension-type headaches per month * diagnosis of secondary headache disorders included medication overuse headache * patients abusing opioids or user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence * implanted metallic or electronic device in the head * cardiac pacemaker or implanted or wearable defibrillator * patient having had a previous experience with the cefaly® device * migraine aura without headache * patient is currently participating or has participated in a study with an investigational compound or device within 30 days of screening visit (visit 1) * patients not having the ability to use appropriately the device and/or to perform themselves or bear the first 20-minute stimulation session during the training session at the study site
effect of peritoneal lavage on surgery-induced positive peritoneal cytology in gastric cancer patients

Conditions: Gastric Adenocarcinoma; Gastric Cancer

Summary: surgical manipulation and handling of a tumor may cause dissemination of cancer cells through peritoneal cavity after curative gastrectomy. intra operative peritoneal lavage may have preventive effect on positive peritoneal cytology occurred during gastrectomy in patients with gastric cancer.

peritoneal dissemination of gastric adenocarcinoma cells is the most frequent cause of death in patients with gastric cancer. spreading of these cells occur by three routes: direct seeding via infiltration through gastric wall, via blood vessels and via perigastric lymphatic channels disturbed during lymph node dissection. conversion of negative preoperative peritoneal cytology to positive cytology after curative gastrectomy has been shown by previous studies. although extensive intra-operative peritoneal lavage (1 l of physiologic saline 10 times) has been shown to be an effective method to eliminate cancer cell dissemination during surgery, to cause significant improvement in survival after gastrectomy, widespread use of this approach has not existed most probably due to its time consuming technical difficulty. therefore,intra-operative peritoneal lavage (1 l of physiologic saline 3 times) may be used more frequently during gastric surgery.if it is possible to show effectivity of intra-operative peritoneal lavage using a total of 3 l physiologic saline to eliminate cancer cell dissemination occurred before or after gastric surgery, use of this approach may gain acceptance to decrease risk of peritoneal metastasis.

Eligibility criteria:
inclusion criteria: * endoscopically proven gastric adenocarcinoma * standard gastrectomy and a d2 lymph node dissection; * desire to attend the study protocol exclusion criteria: * metastatic or overt peritoneal disseminated cancer * undesired reaction to attend the study protocol

Keywords: peritoneal lavage dissemination gastrectomy cytology lavage
fecal dna methylation and helicobacter pylori gastric cancer susceptibility genes test

Conditions: Gastric (Stomach) Cancer

Summary: this is a multicenter, cross-sectional study. it is based on fecal methylation site detection, h. pylori susceptibility testing of fecal samples, and a combination of the two, compared with the "gold standard" imaging tests, ct, gastroscopy and/or pathology, for gastric cancer, benign diseases such as gastritis, and health check-ups.

primary study objective: to evaluate the sensitivity and specificity of fecal methylation site-based and fecal helicobacter pylori gastric cancer susceptibility gene assays applied to early diagnosis and screening of gastric cancer. secondary research objectives: 1. the accuracy, kappa value, area under the roc curve, positive likelihood ratio, negative likelihood ratio, positive predictive value, and negative predictive value of fecal methylation site-based testing and fecal helicobacter pylori gastric cancer susceptibility gene-based testing applied for predicting gastric cancer; 2. whether the predictive ability is significantly higher than that of conventional tumor markers, such as ca19-9, cea, and ca72-4; and 3. the follow up of gastritis and healthy people, to assess the cases of gastric cancer during the follow-up period and the clinical diagnosis and treatment prediction; 4. follow-up gastric cancer patients, to assess the association with gastric cancer recurrence metastasis and treatment.

Eligibility criteria:
inclusion criteria: * age ≥18 years, male or female. * have or will have gastroscopy and/or pathology results. * no contraindications to endoscopy and able to cooperate with endoscopy. * patients must be able to fully understand the informed consent form and be able to sign the informed consent form in person. exclusion criteria: * severe cardiac, hepatic, or renal insufficiency, or psychiatric disorders. * a previous history of malignant tumors of the upper gastrointestinal tract. * women during pregnancy. * those with undefined pathology. * those with unsatisfactory sample retention (e.g., too small a sample size)
peptide vaccination against pd-l1 and pd-l2 in relapsed follicular lymphoma

Conditions: Follicular Lymphoma

Summary: an open phase-1, first-in-human, clinical trial investigating the safety and immunological effects of peptide vaccination with programmed death ligand 1 and 2 (pd-l1 and pd-l2) peptides in patients with relapsed follicular lymphoma.

follicular lymphoma (fl) is the the most common of the indolent lymphomas, with an incidence in denmark of 220 per year. in 90% of the cases the disease is incurable why the treatment strategy often is watchful waiting until significant signs of progression or transformation. after chemotherapy, maintenance therapy is often used to increase disease control. the microenvironment and immune escape mechanism are believed to play a major role in the persistence of the lymphoma. one escape mechanism is the pd-l1 and pd-l2 molecules expressed in the microenvironment of follicular lymphoma inhibiting the t-cells. by stimulating the t-cells to attack pd-l1 and pd-l2 expressing cells we hope to hamper the immunosuppressive tumor environment and establish immune tumor control. 10 patients treated with standard therapy are needed for the trial and each patient will receive 15 vaccinations over the course of one year.

Eligibility criteria:
inclusion criteria: * histologically documented fl grade i-iiia, with no sign of current transformation. patients cured of transformed lymphoma are eligible. * a minimum of one line of induction therapy. maintenance rituximab can continue along with the vaccination * at least partial response to the latest standard treatment * a minimum of 4 weeks since last treatment * age ≥ 18 * ecog performance status of 0 or 1 * life expectancy ≥ 12 weeks * adequate hematologic and end-organ function exclusion criteria: * progression with the presence of at least one gelf criteria or transformation at inklusion time. * other active malignant diseases * significant medical condition per investigators judgement e.g. severe asthma/cold, poorly regulated heart condition, insulin dependent diabetes mellitus. * acute or chronic viral/bacterial infection e.g. hiv, cmv, ebv, hepatitis or tuberculosis * serious known allergies or earlier anaphylactic reactions. * known sensibility towards montanide isa-51 * any active autoimmune diseases e.g. autoimmune neutropenia, thrombocytopenia or hemolytic anemia, systemic lupus erythematosus, scleroderma, myasthenia gravis, autoimmune glomerulonephritis, autoimmune adrenal deficiency, autoimmune thyroiditis etc. * pregnancy

Keywords: pd-l1 pd-l2 peptide vaccine
comparison of general characteristics of patients diagnosed covid-19 (coronavirus )positive followed in service

Conditions: Coronavirus Disease 2019; Vaccinia; Symptoms and Signs

Summary: comparison of general characteristics of patients diagnosed covid-19 positive followed in service

after the explanation about the study is made, informed consent form will be obtained from the pregnant women who were hospitalized in the pandemic gynecology service (d block 10th floor pandemic obstetrics service) due to covid-19 and who agreed to participate in the study. in our study, the clinical status of pregnant patients with covid-19 positive test results, who were followed up and treated in the pandemic service in basaksehir city hospital, will be obtained by asking the patient about the symptoms and vaccination status in the patient follow-up form prepared in advance. laboratory findings and imaging results ( ct/ anteroposterior x-ray) will be obtained from the recorded data.

Eligibility criteria:
inclusion criteria: pregnant patients positive covid-19 test results followed up and treated in the pandemic service of çam and sakura city hospital. exclusion criteria: no exclusion criteria -

Keywords: covid 19, vaccine covid pregnancy vaccine
melanoma image analysis algorithm (miaa) validation study

Conditions: Malignant Melanoma

Summary: prospective, single-arm, cross-sectional, study to establish the effectiveness of miaa to detect melanoma in pigmented lesions, compared to gold standard histological determination.

skin analytics limited have developed an algorithm (miaa) which reviews photographs of pigmented lesions to determine whether melanoma is likely to be present. this study aims to establish how well miaa determines the presence or absence of melanoma, compared to a biopsy. pigmented lesions that a dermatologist has decided to biopsy, and are suitable for photographing, will be photographed up to five times in a single visit. three different camera will be used, and two different dermoscopic lens attachments will be used on smartphone cameras. images will be analysed by miaa and the results compared to the biopsy result. clinicians, patients and the statistical analysis team will be blinded to the result of miaa. at least 65 pigmented lesions positive for melanoma (as determined by biopsy) are required, which is predicted to mean 1250 patients will be recruited.

Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation in the study, * male or female, aged 18 years or above, * have at least 1 lesion suitable for photographing that is scheduled for biopsy to determine the presence of melanoma, * in the investigators opinion, able and willing to comply with all study requirements. exclusion criteria: • any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.

Keywords: diagnosis skin imaging
assessment of the impact of a stepped mouthpiece on the upper airways measured through acoustic pharyngometry

Conditions: Obstructive Sleep Apnea

Summary: mandibular advancements during tidal breathing, achieved through a stepped mouthpiece design, affect the size of the upper airways in subjects with and without obstructive sleep apnea.


Eligibility criteria:
inclusion criteria: * subjects must provide written informed consent to participate in the study. * adult male or female subjects over 18 years of age who have or have not been diagnosed with osa. * subjects claiming no history of osa should take the epworth questionnaire and obtain a result less than 10. * subjects must satisfy the study investigator about their fitness to participate in the study. * subjects must be available to complete the study. exclusion criteria: * subjects not compliant with the instructions for use of the stepped mouthpiece and the study procedures. * subjects who have participated in a clinical trial in the previous month.

Keywords: to evaluate the effect of advancing jaw on airway dimension
a short term evaluation of a structured weight loss plan in overweight and obese adults

Conditions: Metabolic Syndrome

Summary: the present study is designed to examine the effect of changes in body weight and related parameters associated with a commercially-available, low-carbohydrate diet plan. a parameter proposed to be studied here is the impact of fructose restriction and weight loss on serum uric acid concentrations and arterial stiffness.

it is well know that consumption of a calorically-restricted diet helps people lose weight. such a diet with low carbohydrate lowers the serum uric acid concentration which is a factor associated with obesity and also represents a particular metabolic risk in women compared to men. the present weight loss study will determine whether women benefit more than men to short-term weight loss occurring during restriction of simple sugars. specifically, this study is designed to cause weight loss acutely through consumption of a diet that is restricted in calorie and simple sugars. both men and women will be studied and their results compared to determine whether women benefit more with respect to arterial stiffness. upon finishing the four-week diet intervention, body weight and blood lipids will be assessed two and four weeks later to compare the longer term effect on blood pressure.

Eligibility criteria:
inclusion criteria: 1. men and premenopausal women 2. 30-55 years of age 3. sedentary lifestyle, defined as less than three sessions of activity per week, or sessions less than 20 minutes per occasion, or less than 5000 steps per day 4. must be able to speak, read, and write english (due to the small sample size and pilot nature of this study) 5. overweight/obese subjects with bmi 27.0 - 40.0 kg/m2 and any one of the following characteristics of the metabolic syndrome: a. serum hdl cholesterol \ 102 cm (40 in) and in women of \>88 cm (35 in) e. serum triglycerides (tg) ≥150 mg/dl (1.7 mmol/l). exclusion criteria: 1. abnormal thyroid function or known liver disease 2. diabetes or fasting glucose ≥ 125 mg/dl 3. use of medications that interfere with protein, carbohydrate or lipid metabolism (e.g., fish oil capsules) 4. occasional or regular tobacco use 5. history of gout 6. uncontrolled hypertension 7. pregnant or peri-menopausal 8. vegetarian food restrictions (the diets consumed contain some meat, eggs and dairy) 9. alcohol intake: females \> 70 g/wk, males \>140 g/wk 10. moderate or vigorous-intensity physical activity, defined as more than 150 minutes per week of moderate-intensity, or 75 minutes a week of vigorous-intensity aerobic physical activity, or an equivalent combination of both.

Keywords: gender arterial stiffness blood pressure weight loss uric acid
day-night rhythm in human skeletal muscle

Conditions: Diabetes Mellitus, Type 2; Insulin Resistance

Summary: this study evaluates the existence of a day-night rhythm in skeletal muscle energy metabolism in healthy lean subjects. subjects will stay at the research facility for 44 hours with a standardized living protocol during which several measurements of skeletal muscle and whole body energy metabolism will be performed.

recent evidence from both observational and experimental studies indicates that disobeying our normal day-night rhythm negatively influences our metabolic and cardiovascular health, possibly leading to obesity and type 2 diabetes mellitus (t2dm). an important hallmark of obesity and t2dm is a decreased skeletal muscle mitochondrial function. interestingly, recent research indicates that also skeletal muscle mitochondrial function under the influence of a day-night rhythm. the main objective of this study is to investigate the presence of a day-night rhythm in skeletal muscle energy metabolism (in particular mitochondrial function) of healthy young participants. therefore, subjects will stay at the research unit for 44 hours, with standardized meals and sleeping time. during this period we will take five muscle biopsies, perform indirect calorimetry measurements and blood draws.

Eligibility criteria:
inclusion criteria: * caucasian * healthy (as determined by dependent physician based on medical questionnaire) * male * age: 18-35 years * normal bmi (18-25 kg/m2) * regular sleeping time (normally 7-9h daily) exclusion criteria: * extreme early bird or extreme night person (score ≤30 or ≥70 on meq-sa questionnaire) * heavily varying sleep-wake rhythm * shiftwork during last 3 months * travel across \>1 time zone in the last 3 months * engagement in exercise \> 2 hours total per week * using \>400mg caffeine daily * smoking * unstable body weight (weight gain or loss \> 3kg in the last 3 months) * significant food allergies/intolerance (seriously hampering study meals) * participation in another biomedical study within 1 month before the first study visit * any contra-indication to magnetic resonance imaging (mri) scanning

Keywords: circadian rhythm