Kornimate/medical-research-clean huggingface dataset:
the impact of osmotic release oral delivery system methylphenidate (oros mph) upon family of children and adolescents with attention deficit hyperactivity disorder (adhd)

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: the purpose of this study is to evaluate whether familial relationships and psychological status of participants or caregivers as well as attention deficit hyperactivity disorder (adhd) symptoms of participants can be improved by switching from immediate-release methylphenidate (ir-mph) to osmotic release oral delivery system methylphenidate (oros-mph).

this is a prospective (study following participants forward in time), single-arm, open-label (all people know the identity of the intervention), 8-week, multi-centric (conducted in more than 1 center) study. oros-mph will be administered orally for 2 months at doses of 18, 36, or 54 milligram (mg) to replace ir-mph. clinicians will adjust the dose of each participant according to participant's clinical responses and/or side effects. during the study period, participants will be assessed on week 2, 4, and 8. efficacy will be evaluated primarily based on change from baseline in chinese version of the 26-item swanson, nolan and pelham-fourth edition (snap-iv) rating scale assessed by parents and chinese health questionnaire (chq). safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * participants who are diagnosed with attention deficit hyperactivity disorder (adhd) according to diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) * participants who have been treated with immediate-release methyphenidate (ir-mph) for at least 4 weeks before enrollment, but previous treatment is considered unsatisfactory due to 1 or more of the following reasons: lack of effectiveness, lack of tolerability or safety, lack of compliance, and/or other reasons * participants who are able to comply with the study visit schedule and whose parents/caregiver and community school teacher are willing and able to complete the protocol-specified assessments * participants who are still at school * participants who are treated with greater than equal to 10 milligram (mg) ir-mph daily before enrollment exclusion criteria: * participants who cannot understand or follow the instructions given in the study * participants with serious or unstable medical illness * participants who have clinically significant gastrointestinal problems, including narrowing of the gastrointestinal tract * participants who have glaucoma (increased pressure inside the eye that causes visual problems), an ongoing seizure disorders, or a psychotic disorder * participants who are hypersensitive to methylphenidate * participants who have any co-existing medical condition or are taking a concomitant medication that is likely to interfere with safe administration of methylphenidate

Keywords: attention deficit disorder with hyperactivity methylphenidate concerta
aortic stiffness in chronic kidney disease stage 2 to 4

Conditions: Decline in Renal Function

Summary: this study aimed to investigate in a cohort with chronic kidney disease the longitudinal relationship between aortic stiffness and renal function and mortality.


Eligibility criteria:
inclusion criteria: * age 18 or older * ckd 2-4 exclusion criteria: * pregnancy * history of malignant disease with a prognostic life expectancy less than 24 months * missing of written and informed consent

Keywords: chronic kidney disease ckd pulse wave velocity pwv
hiv and drug use in georgian women

Conditions: Human Immunodeficiency Virus

Summary: the purpose of this study is to determine how drug abuse treatment interventions can be integrated with established human immunodeficiency virus prevention approaches to optimize their combined effectiveness.

eastern europe is an emerging epicenter of injection drug use and human immunodeficiency virus infection, among women. within eastern europe, the republic of georgia is one of the last countries where an human immunodeficiency virus epidemic can still be averted. this proposal responds to rfa-da-10-008 international research collaborations on human immunodeficiency virus/acquired immunodeficiency syndrome and drug use by building on the successful collaboration among united states and eastern european investigators from the republic of georgia and russia. recent data from georgia's neighbor, russia, reported 59% of injection drug using women human immunodeficiency virus seropositive; this is a threat that looms over georgia. understanding the risk factors that operate in russia that drive this epidemic may help forestall such a catastrophe in georgia. as such, this proposal directly responds to the eastern european region question of "how can drug abuse treatment interventions be integrated with established human immunodeficiency virus prevention approaches to optimize their combined effectiveness?" injection drug using georgian women show prevalence rates of 2% for human immunodeficiency virus and 25% for hepatitis c. the low prevalence of human immunodeficiency virus in georgian women provides an important window of opportunity to intervene and avoid the possibility of a human immunodeficiency virus epidemic. in georgia, women's expected subordination to men makes women vulnerable to human immunodeficiency virus/hepatitis c infection. the public health impact of the proposed project is far-reaching. taken to scale, our georgian reinforcement-based treatment model holds the promise not only to lessen the possibility of a human immunodeficiency virus epidemic and slow the increase in the hepatitis c transmission rate in georgia, but also to strongly influence the development of women-focused drug abuse intervention models for treatment tailoring and dissemination in other nations.

Eligibility criteria:
inclusion criteria: * conversant in georgian * able to provide informed consent * age 18 years or older * has ever injected illicit drugs * sexually active at least once in the past 30 days. exclusion criteria: * male * younger than 18 years * not sexually active at least once in past 30 days * not able to provide informed consent

Keywords: hiv hiv risk sexually transmitted diseases drug use women drug treatment opioids injection drug use stimulants gender-specific treatment
a study of darzalex (daratumumab) in indian participants with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent

Conditions: Multiple Myeloma

Summary: the purpose of this study is to demonstrate the safety profile of daratumumab in routine clinical practice when given as monotherapy in indian participants with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent.


Eligibility criteria:
inclusion criteria: * participants with relapsed and refractory multiple myeloma (as per international myeloma working group \[imwg\] definitions) whose prior therapy included a proteasome inhibitor and an immunomodulatory agent, being newly initiated on darzalex (daratumumab) monotherapy based on independent clinical judgment of treating physicians as per locally approved prescribing information * each participant (or their legally acceptable representative) must sign an informed consent form (icf) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study. participants must be willing and able to adhere to the prohibitions and restrictions specified in this protocol, as referenced in the informed consent form (icf) exclusion criteria: * participants who are not eligible to receive darzalex as per the locally approved prescribing information * participant participating or planning to participate in any interventional drug trial during the course of this study * known seropositive for human immunodeficiency virus (hiv) * seropositive for hepatitis b (defined by a positive test for hepatitis b surface antigen \[hbsag\]). participants with resolved infection (that is, participants who are hbsag negative but positive for antibodies to hepatitis b core antigen \[anti-hbc\] and/or antibodies to hepatitis b surface antigen \[anti-hbs\]) must be screened using real-time polymerase chain reaction (pcr) measurement of hepatitis b virus (hbv) deoxyribonucleic acid (dna) levels. those who are pcr positive will be excluded. exception: participants with serologic findings suggestive of hbv vaccination (anti-hbs positivity as the only serologic marker) and a known history of prior hbv vaccination, do not need to be tested for hbv dna by pcr * known seropositive for hepatitis c (except in the setting of a sustained virologic response \[svr\], defined as aviremia at least 12 weeks after completion of antiviral therapy)
a pilot study testing fractional radiofrequency versus fractional photothermolysis for the treatment of acne scars

Conditions: Cicatrix

Summary: the purpose of this study is to compare the effectiveness of the eprime fractional radiofrequency system to the 1550-nm fractional photothermolysis system (fraxel) in the ability to improve acne scar appearance.

participants in this study will be patients at the dermatology clinic with icepick and boxcar acne scars on at least one 2 x 2 cm area on each side of face. subjects will be randomly assigned to receive fractional radiofrequency treatment to either the right or left side of the face and the contralateral side will receive 1550-nm fractional photothermolysis. subjects will receive treatments at baseline, week 4, and week 8 for a total of three treatments. follow up visits will take place at week 16, two months following the last treatment visit. this study is a pilot study designed to determine feasibility of these procedures.

Eligibility criteria:
inclusion criteria: 1. subjects age 18 years and older. 2. subjects with bilateral 2x2 cm areas of ice pick and/or boxcar acne scars on their face. 3. subjects are in good health. 4. subjects have the willingness and the ability to understand and provide informed consent and communicate with the investigator. exclusion criteria: 1. subjects who have received injectable soft-tissue augmentation materials to the face, or facial ablative resurfacing, within the past 6 months. 2. subjects who have received injectable botulinum toxin to the face, or any nonablative laser treatment to the face, within the past 3 months. 3. subjects who have local infections, open facial wounds, or other significant local skin disease that would interfere with acne scar treatment with energy devices. 4. subjects who are allergic to lidocaine or prilocaine. 5. subjects who have a history of abnormal scarring in the treatment area, such as keloid scar formation. 6. subjects who have ectropion or or other eyelid disfigurement. 7. subjects who have a history of isotretinoin use in the preceding year. 8. pregnant or lactating individuals.
changes in the treatment of acute appendicitis

Conditions: Acute Appendicitis

Summary: the purpose of this study was to analyse the epidemiology, diagnostics, the type of surgical techniques and their development over time, and mortality in acute appendicitis in 68 hospitals in germany based on routine data between 2010 and 2022.

this retrospective observational study analyzed routine data provided by the clinotel hospital association germany, covering the years 2010 to 2022. the data was derived from anonymized billing data according to the german diagnosis-related groups (drg) system for inpatient hospital treatments. the study focused on the use of different surgical techniques for appendectomy over time, the in-hospital mortality rates and postoperative complications associated with the performed kind of appendectomy. patients over 18 years with an acute appendicitis were included by collecting following data: patient demographic, comorbidity, performed operation, postoperative complications, admission to intensive care unit, length of stay, and in-hospital-mortality. cases without an appendectomy, with nonspecific appendectomy and those, who underwent appendectomy as part of another surgical procedure, were excluded. furthermore, all cases with multiple appendectomy codes were removed from the sample. ultimately, 31988 patients were included in the study.

Eligibility criteria:
inclusion criteria: * acute appendicitis exclusion criteria: * age under 18 years * no appendectomy performed

Keywords: acute appendicitis type of appendectomy
ultrasonography sensibilized by oral hydration and hydronephrosis in children.

Conditions: Hydronephrosis in Children

Summary: diagnosis and follow up of hydronephrosis is actually based on repeat ultrasonography and scintigraphy wich is a binding exam for children. we wanted to evaluate the use of ultrasonography sensibilized by an oral hydration and to determine its efficiency to detect which hydronephrosis need a surgery or not.


Eligibility criteria:
inclusion criteria: * child of 30 days old or less * unilateral or bilateral hydronephrosis (pelvis \> 5mm ) exclusion criteria: * complex uropathy * diuretic administration 6 hours prior to ultrasonography or scintigraphy * oral feeding trouble

Keywords: hydronephrosis
correlation of serum lactate and activity of multiple sclerosis

Conditions: Multiple Sclerosis

Summary: correlation of serum lactate and activity of multiple sclerosis and its correlation to different type of ms

correlation of serum lactate and activity of multiple sclerosis and its correlation to different type of ms and magentic resonanace imaging , magentic resonanace spectroscopy

Eligibility criteria:
inclusion criteria: -patients with multiple sclerosis (rrms,ppms and spms) exclusion criteria: -patients with any other medical conditions that may affect the serum lactate level

Keywords: multiple sclerosis, serum lactate and mrs
thumb hemi-arthroplasty with natural kinematics; a prospective multicenter study to confirm the safety and efficacy of the indx implant

Conditions: CMC Joint Arthritis

Summary: prospective, multicentric non-comparative confirmatory study to evaluate the safety and performance of the indx cmc implant for the treatment of cmc joint arthritis.


Eligibility criteria:
inclusion criteria: * the patient is at least 18 years of age; * the patient has a confirmed grade i-iii osteoarthritis of the cmc joint on clinical examination and x-ray; * the patient is eligible for surgical treatment of cmc i arthrosis in the opinion of the investigator. * the patient agrees to abstain from enrolment in any other clinical trials that will conflict or interfere with the interpretation of the results of this study, in the opinion of the investigator, for the duration of the study; * the patient is able to understand the aims and objectives of the trial and is willing to consent; * the patient is willing and able to return for all study-related follow-up procedures; * if the patient is female, is either using contraception or is postmenopausal, or male partner is using contraception exclusion criteria: * the patient is suffering from rheumatoid arthritis in the index hand; * the patient is suffering from grade iv osteoarthritis of the cmc joint; * the patient is suffering post-traumatic arthritis of the cmc joint in the index hand; * the patient is a pregnant/lactating female (tested as per institutional requirements); * active or latent infection, or sepsis; * insufficient quantity or quality of bone and/or soft tissue in the index hand; * metal or polymer material sensitivity; * muscular imbalance, peripheral vascular disease that prohibits adequate healing, or a poor soft-tissue envelope in the surgical field, absence of musculoligamentous supporting structures, or peripheral neuropathy; * patient with previous thumb surgery in the index hand * in the opinion of the investigator, any medical condition that makes the subject unsuitable for inclusion in the study, including, but not limited to * patients with a diagnosis of concomitant injury that may interfere with healing * patients with clinically significant renal, hepatic, cardiac, endocrine, hematologic, autoimmune, or any systemic disease or systemic infection that may make interpretation of the results difficult * patients who have undergone systemic administration within 30 days prior to implantation of any type of corticosteroid, antineoplastic, immunostimulating, or immunosuppressive agents * comorbidity that reduces life expectancy to less than 36 months
optimisation of primary hiv1 infection treatment(anrs 147 optiprim)

Conditions: HIV-1 Infections

Summary: the purpose of this trial is to assess the impact of raltegravir, maraviroc, darunavir/r, and truvada® (emtricitabine/tenofovir) vs. darunavir/r and truvada® on cell-associated hiv-dna levels in patients with primary hiv-1 infection.

primary hiv-1 infection is characterized by a phase of intense replication, with a quick dissemination and early changes in the immune system. during primary hiv-1 infection, damages to malt and galt promotes a chronic cell activation, which participates in a progressive decay of immune functions. after haart initiation, the magnitude and rapidity of cell-associated hiv-dna decrease are significantly higher in patients with primary hiv-1 infection than in patients with chronic infection (ngo giang huong, aids 2004). we hypothesize that an early intervention at different levels of viral replication with potent and well-tolerated new drugs may have a greater impact on cell-associated hiv-dna levels than conventional triple-drug haart.

Eligibility criteria:
inclusion criteria: * patients with acute or primary hiv-1 infection * acute infection: negative or slightly positive elisa, with negative or incomplete western-blot (0 or 1 antibody) and positive hiv-rna and/or positive ag p24. * primary infection: positive elisa with incomplete western-blot (≥ 2 and \< 5 antibodies with the presence of anti-p24 antibodies associated with an anti-gp160 or an anti-gp120 or an anti-gp41antibody) and positive hiv-rna. * symptomatic primary infection or cd4 \<500/mm3 * written informed consent * ≥ 18 years old exclusion criteria: * prior post exposure antiretroviral treatment within six months before enrolment * pregnancy or breast-feeding * hiv-2 infection * current malignancy * prothrombin time \< 50% * creatinine clearance \< 60 ml/min * asat, alat or bilirubin ≥10\*n * platelets \< 25000/mm3

Keywords: primary hiv-1 infection antiretroviral treatment hiv reservoirs hiv-dna levels randomized treatment naive
gabapentin for the reduction of opiate use following pulmonary resection (group trial)

Conditions: Thoracic; Pulmonary Disease

Summary: the aim of this study is to determine if the reduction in narcotic requirement following pulmonary resection with gabapentin is clinically significant when compared to the effect seen with placebo. we have defined clinically meaningful as a reduction by 30 morphine equivalent doses (med)

study objectives: the aim of this study is to determine if the reduction in narcotic requirement following pulmonary resection with gabapentin is clinically significant when compared to the effect seen with placebo. we have defined clinically meaningful as a reduction by 25% morphine equivalent doses (med) secondary objectives are to evaluate the utility of gabapentin in reducing postoperative pain, reducing hospital length of stay, promoting faster return to baseline function (to be assessed by mdasi), preventing post thoracotomy pain syndrome (to be assessed by bpi), and reducing the rate of chronic opiate use among patients undergoing thoracic procedures. 1. primary endpoint the primary outcome will be the sum of the daily average morphine equivalent dose of opioids recorded from day of surgery (day 0) through 7 days after surgery, for a total of 8 days. 2. secondary endpoints * time to resuming normal activities * presence/absence of chronic pain at 3 and 6 months, measured by bpi * 30, 90, 180 day opiate use (y/n) * mdasi on post-operative days 7, 30, 90, 180 * basic pain inventory (bpi) on post-operative days 1,2, 7, 30, 90, 180 * daily pain score during hospitalization * length of hospital stay * need for opioids at discharge * whether medication is stopped prior to day 25, and if so when and for what reason.

Eligibility criteria:
inclusion criteria: * age 18+ * undergoing pulmonary resection (includes metastasectomy as well as anatomic resections) * must have device with email capabilities for follow up survey exclusion criteria: * requiring narcotic pain medication or gabapentin at the time of preoperative appointment or within 30 days of surgery * renal impairment requiring dialysis * allergy to gabapentin
comprehensive screening for women at high genetic risk for developing breast cancer

Conditions: Breast Cancer

Summary: to screen women who are high risk for breast cancer with breast mri, mammogram and random periareolar fine needle aspiration.

general purpose: the purpose of our protocol is develop a comprehensive screening protocol for women at high risk for developing breast cancer in the hopes of detecting breast cancer or it's precursor lesions at the earliest possible stage and reducing breast cancer mortality. the following are our specific goals in this endeavor; 1. to assess the sensitivity and specificity of mri in breast cancer detection in women at high risk compared to mammography 2. to assess the ability of random periareolar fine needle aspiration to detect abnormal ductal cells and to correlate these results with mri and mammogram findings 3. to assess appropriate screening intervals for brca1/2 mutation carriers and women with a \>10% risk of developing breast cancer in ten years the following aims will be outlined in detail under methodology.

Eligibility criteria:
inclusion criteria:subjects must be female, between the ages of 25 and 65, or ten years younger than the youngest breast cancer diagnosed in the family, or have no mutation identified but have a greater than 10% risk of developing breast cancer in ten years (based on the claus model). may have had previous breast or ovarian cancer, but must be at least one year out from treatment of a stage 1 or early 2 cancer.