Kornimate/medical-research-clean huggingface dataset:
clinical study to test a new drug to treat major depression

Conditions: Depressive Disorder, Major

Summary: in this randomized, double-blind, multi-centre, placebo controlled, exploratory, adaptive design study, the antidepressant and plasma cytokine lowering effects of the gw856553 will be investigated in adult subjects diagnosed with mdd. subjects will receive oral doses of gw856553 or placebo for six weeks. safety, tolerability, pharmacokinetics and pharmacodynamics, defined as biomarkers in blood and clinical symptoms, will be assessed. the primary endpoint is the change from baseline associated with gw856553 versus placebo at week 6 in the bech (6-item hamd-17) score. interim analyses of the primary endpoint will be performed throughout the study to potentially adapt the study design by changing the randomization ratio and/ or reducing the total number of subjects to be randomized into the study. exploratory analyses will be performed by associating changes in cytokine levels and selected clinical symptoms; pk/pd modelling will also be used to identify the most sensitive clinical and biological markers.


Eligibility criteria:
key inclusion criteria: * adult subjects with primary diagnosis of moderate to severe mdd without psychotic features, for at least 4 weeks and one previous mdd episode * males or females who agree to use protocol specified contraception if of child bearing potential * bmi 18.5-35.0 kg/m2 * normal liver function tests key exclusion criteria: * history of liver disease or positive hepatitis b surface antigen or hepatitis c antibody in the last 3 months * elevated liver function tests on \>2 ocassions in the last 7 months * significant medical illness, autoimmune disease or infectious disease * pregnant or nursing females * excessive and regular alcohol consumption * history of substance abuse or dependence in past 6 months or positive urine drug screen * significant suicidal or homicidal risk * currently receiving chronic biological or pharmacologic anti-inflammatory therapy or is not euthyroid * psychoactive drugs within 1 week or 5 half lives of randomization visit * treatment resistant subjects

Keywords: lack of interest and energy psychomotor retardation cytokines major depressive disorder
music therapy in sickle cell pain mixed methods study

Conditions: Sickle Cell Disease

Summary: the purpose of this research study is to: 1. investigate the effects of a single 20-minute music therapy intervention with a music therapist on the pain intensity, pain relief, and mood of adult patients with sickle cell disease as compared to: 1. adult patients with scd who listen to their preferred music for 20 minutes without the presence of a music therapist (music listening group) 2. adult patients with scd who receive standard care alone (control group) 2. determine the feasibility (delivery, acceptability, and usefulness) of the music therapy intervention for pain management


Eligibility criteria:
inclusion criteria: * subjects who have a diagnosis of sickle cell disease (hbss, hbsc, hbsbeta+thal, or hbsbeta0thal) * 18 years or older * able to speak and understand english exclusion criteria: * patients who have significant hearing impairments and/or significant visual impairments that have not been corrected

Keywords: music therapy sickle cell disease pain
post-marketing surveillance regarding efficacy and safety of spaceoar™

Conditions: Prostate Cancer Patients Treated by Radiotherapy

Summary: a treatment with spaceoar™ hydrogel does reduce late toxicity grad 2 and grad 3 of radiation therapy in prostate cancer patients

the degradable spaceoar™ hydrogel establishes for the time of radiotherapy a distance between the prostate and the rectum

Eligibility criteria:
inclusion criteria: * patient is suffering from pathologically confirmed t1-t2, n0, m0 prostate adenocarcinoma. * patient is intended to receive radiation therapy (3d-computerized radiotherapy, intensity-modulated radiotherapy, and/or brachytherapy) and this will be the first prostate or pelvic radiation therapy. * patient is intended to receive spaceoar™ gel therapy. * the patient is official patient of the clinical investigator in the study centre. * patient agrees to fully participate in the clinical trial and give informed consent in writing. exclusion criteria: * anatomic abnormality, physical or pathological condition precluding the implantation. * failure in the wall of the perineum room (with the risk that the hydrogel escapes). * history of prostate surgery or local prostate cancer therapy. * rectal injury before implantation of spaceoar™ gel or history of or active inflammatory rectal disease such as crohn's disease or ulcerative colitis. * history of or current perirectal or anal disease or surgery such as prolapsed or bleeding haemorrhoids or fistula. * compromised immune system (e.g., hiv/acquired immunodeficiency syndrome, auto¬immune disease or immunosuppressive therapy). * platelet count, partial thromboplastin time, or white blood cell count out of normal laboratory range. * contraindication for safe mri and ct scans. * patient is not able to fully participate in this study including the follow-up (e.g. for mental or geographical reasons, or patient is intravenous drug user or has strong potential for non-compliance to medical regimes). * patient is mentally unable to understand the nature, aims, or possible consequences of the clinical investigation. * patient has restricted legal capacity. * patient did participate in another clinical investigation during the last 3 months. * patient has revoked the consent.

Keywords: prostatic neoplasms radiotherapy rectal toxicity
message encouraging vaccination in preparation for the holidays

Conditions: COVID-19

Summary: this experiment is part of a megastudy with a total of ten experimental conditions and a holdout control condition to which patients will be randomly assigned. ther focal comparison in this experiment is between a message encouraging vaccination by reminding participants that the holiday season is just a few weeks away and getting vaccinated will allow them to more safely gather with loved ones and a control message telling patients that an updated covid booster vaccine is waiting for them. the intervention testing if text messages encouraging vaccination by reminding participants that the holiday season is just a few weeks away and getting vaccinated will allow them to more safely gather with loved ones will produce more vaccinations than otherwise identical messages.


Eligibility criteria:
exclusion criteria: 1. the patient unsubscribed from texts before the send date and time of the patient's sms/mms message 2. the patient received a bivalent covid booster before the send date and time of the patient's sms/mms message.

Keywords: covid-19 behavioral science interventions vaccination promotion
pubmic (prophylactic use of biologic mesh in ileal conduit)

Conditions: Bladder Carcinoma; Hernia

Summary: this randomized phase iii trial studies how well biologic mesh works in preventing parastomal hernia in patients with bladder cancer who are undergoing radical cystectomy, or removal of the bladder, and ileal conduit diversion. an ileal conduit is a tube created from your small intestine that will be used as a tube for urine to flow out of your body. parastomal hernia is a type of hernia that can occur in the stomach area where the ileal conduit is placed. biologic mesh may help prevent parastomal hernia following surgery and ileal conduit diversion.

primary objectives: i. to estimate the rate of developing parastomal hernia detected either clinically or radiologically in patients with radical cystectomy and ileal conduit, with or without mesh. secondary objectives: i. to estimate the rate of developing symptomatic parastomal hernia requiring surgical intervention in patients with radical cystectomy and ileal conduit with or without mesh. ii. to estimate the time from cystectomy with an ileal conduit to diagnosis of clinical parastomal hernia development in patients with radical cystectomy and ileal conduit with or without mesh. iii. to estimate the time from cystectomy with an ileal conduit to diagnosis of radiological parastomal hernia development in patients with radical cystectomy and ileal conduit with or without mesh. iv. to estimate the rate of stomal prolapse and time to its development in patients with radical cystectomy and ileal conduit with or without mesh. v. to evaluate mesh-related complications in mesh group. outline: patients are randomized to 1 of 2 arms. arm i: patients undergo placement of biologic mesh during radical cystectomy and placement of the ileal conduit. arm ii: patients undergo standard of care radical cystectomy and placement of the ileal conduit. after completion of study, patients are followed up every 2-4 months for 2 years.

Eligibility criteria:
inclusion criteria: * bladder cancer, undergoing radical cystectomy and ileal conduit diversion * ability to understand and the willingness to sign a written informed consent * follow-up either here at university of southern california (usc) or centers that are available to transfer the requested clinical and radiological data exclusion criteria: * previous scar or mesh at the level of ileal conduit * survival less than 12 months after surgery (either predicted survival before surgery or actual survival after surgery \< 12 months) * history of allergic reactions attributed to compounds of similar chemical or biologic composition to cadaveric component, i.e. flex hd
internet-versus group-administered cognitive behavior therapy for panic disorder

Conditions: Panic Disorder

Summary: panic disorder with or without agoraphobia (pd/a) is a common, and unless it is treated, often chronic psychiatric disorder. the are effective pharmacological as well as psychological treatments for pd/a. because of the lack of availability of the most effective psychological treatment, cognitive behavior therapy (cbt), self-help based cbt treatments have been developed. one of those are internet-based cbt. the aim of this study is to compare the effectiveness of internet and group cbt for pd/a in a regular psychiatric setting. 113 patients are consecutively and randomly assigned to either treatment (both lasting 10 weeks). the main outcome measure is the panic disorder severity scale(pdss). the study hypothesis is that treatments will show equal effectiveness.


Eligibility criteria:
inclusion criteria: * primary panic disorder with or without agoraphobia (pd/a) exclusion criteria: * active substance abuse * physiological etiology of panic symptoms * under 18 years of age * severe depression or suicidal ideation. * if on drugs for pd, not having had a constant dosage for 2 months * undergoing other cognitive behavioral treatment
human umbilical cord blood (regenecyte) infusion in patients with post-covid syndrome

Conditions: Long COVID; Post-COVID Syndrome; Post COVID-19 Condition

Summary: regenecyte (hpc, cord blood, hucb) for treatment in patients with post-covid.

this is a two-arm, single-center, single-blind, randomized, placebo-controlled phase iia study. a total of 30 subjects with post-covid will be enrolled.

Eligibility criteria:
inclusion criteria: * 1. male or female aged ≥ 18 * 2. with post-covid syndrome * 3. has had a recent (within 7 days) negative sars-cov-2 test (an approved pcr or antigen test) * 4. able to provide signed informed consent (by the subject or his/her legally authorized representative) * 5. is willing and able to participate in all aspects of the study, including completion of subjective evaluations, attendance at scheduled clinic visits, and compliance with all protocol requirements as evidenced by providing a written informed consent exclusion criteria: * 1. neurological disorders prior to covid-19 diagnosis * 2. with pre-existing terminal illness * 3. with known immune disease * 4. is pregnant or breastfeeding * 5. is currently participating in another investigational study or has been taking any other investigational product within the last 4 weeks before screening * 6. has received any vaccination within 3 weeks prior to the first ip infusion * 7. judged by the investigator to be not suitable for study participation * 8. under the conditions that may increase risk of complications based on the medical judgment of the investigator and the parameters

Keywords: long covid post-covid syndrome post-covid condition umbilical cord blood regenecyte
en3285 for the prevention or delay of oral mucositis in patients with head and neck cancer

Conditions: Oral Mucositis; Head and Neck Cancer

Summary: randomized, double-blind, placebo-controlled study for the treatment of head and neck cancer(hnc), to assess the ability of en3285 to prevent or delay the onset of severe oral mucositis(om).

this randomized, double-blind, placebo-controlled study will be conducted in patients receiving chemoradiotherapy (chemort) for the treatment of head and neck cancer(hnc), to assess the ability of en3285 to prevent or delay the onset of severe oral mucositis(om). the study includes a treatment period of up to 8 weeks, based on the patients' prescribed treatment plan, with a follow-up period of 12 months following completion of radiotherapy (rt).

Eligibility criteria:
significant inclusion criteria: * 18 years and older * newly diagnosed scc of the oral cavity and/or oropharynx, and are intended for treatment with chemort. * have a clinical plan to receive a minimum of 60 gy to the oral cavity and/or oropharynx * chemotherapy: cisplatin * have a wbc ≥3500 per cubic millimeter * have a platelet count ≥100,000 per cubic millimeter * have adequate renal function as determined by the principal investigator prior to enrollment * are willing and able to undergo oral assessments * have a karnofsky performance status score ≥70 significant exclusion criteria: * have om or other oral conditions at study entry * plan to use amifostine, pilocarpine, cevimeline or bethanechol * are using a pre-existing feeding tube for nutritional support at study entry * plan to use any drug for the treatment or prevention of om * have had any prior radiotherapy to the head and neck * have had prior chemotherapy within 6 months preceding enrollment * plan to have concurrent chemotherapy, other than those regimens specified under inclusioncriteria * have received other investigational drugs in the 30 days preceding initiation of study drug or during administration of study drug * have medical conditions that require the use of chronic steroid therapy * have the inability to undergo repeat treatments,

Keywords: oral mucositis chemoradiation therapy head and neck cancer
long-term protection of vi antibodies induced by bio tcv in indonesian population compared to pqed tcv

Conditions: Antibody Typhoid Vaccine

Summary: typhoid fever is a serious systemic infection caused by the enteric pathogen salmonella enterica serovar typhi. s typhi is spread by the fecal-oral route. although largely an endemic disease, s. typhi has epidemic potential. this research aims to determine the long-term immune response after administration of one dose of bio tcv and pqed tcv vaccines in the population in indonesia. research participants will be taken from research participants who complete the bio tcv (typhoid 0319) phase iii clinical trial research included in the main study group i.

typhoid fever is a serious systemic infection caused by the enteric pathogen salmonella enterica serovar typhi. s typhi is spread by the fecal-oral route. although largely an endemic disease, s. typhi has epidemic potential. data mainly from asia, africa and latin america show that typhoid fever continues to be a public health problem in many developing countries, with school-age children (aged 5-15 years) disproportionately affected. in some endemic areas, children aged \< 5 years show incidence rates similar to, or exceeding those, of school age children. who conservatively estimates the annual global incidence of typhoid fever at 21 million cases, of which 1-4% ends fatally. an estimated 90% of these deaths occur in asia. increasing multidrug resistance of s. typhi reduces the effective treatment options, increases treatment costs and results in higher rates of serious complications and deaths. this research aims to determine the long-term immune response after administration of one dose of bio tcv and pqed tcv vaccines in the population in indonesia. research participants will be taken from research participants who complete the bio tcv (typhoid 0319) phase iii clinical trial research included in the main study group i. during the research, participants will make one (1) research visit to the health center for examination and blood sampling. after 5 years of being given the typhoid vaccine, participants will be contacted by telephone to be given information about the research that will be conducted on you/your child. the research team will ask questions about the willingness to participate in the research. if they agree, a visit will be scheduled to the research site. this research is conducted by the department of pediatrics, cipto mangunkusumo hospital, jakarta, dr. soetomo hospital, surabaya and pt bio farma.

Eligibility criteria:
inclusion criteria: * healthy * subject/parents/legal guardian(s) have been informed properly regarding the study and signed the informed consent form/and informed assent form. * subject/parents/legal guardian(s) will commit to comply with the instructions of the investigator and the schedule of the trial. exclusion criteria: * history of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy.
exercise during active surveillance for prostate cancer

Conditions: Prostate Cancer

Summary: the broad goal of the exercise during active surveillance for prostate cancer (erase) trial is to examine the effects of exercise in prostate cancer patients undergoing active surveillance.

the erase trial will be a phase ii randomized controlled trial. a total of 66 men with low- or intermediate-grade clinically localized prostate cancer undergoing active surveillance will be randomized to either a 12-week of supervised high-intensity aerobic interval training or usual care. the primary outcome will be peak oxygen consumption (vo2peak) as a measure of physical fitness. the secondary outcomes include tumour-related biomarkers, fear of cancer progression, quality of life, and psychological distress. exploratory outcomes will include indicators of cancer progression including prostate-specific antigen. based on this sample size, our study has 80% power with a two-tailed alpha \<0.05 to detect a clinically meaningful effect of 3.5 ml/kg/min on our primary outcome of vo2max. this power will also be sufficient for detecting differences in our secondary biomarkers and patient-reported outcomes if the effects are at least moderate (i.e., a standardized effect size of d=0.60).

Eligibility criteria:
inclusion criteria: * ≥18 years of age * diagnosed with low or favorable intermediate grade localized pca defined as psa less than 10, gleason score 3+3 or 3+4 with low volume, and digital rectal examination (dre) of t1c or t2a * initiating or continuing active surveillance with no plans for treatment for prostate cancer in the next 6 months (e.g., radical prostatectomy, radiotherapy, or androgen deprivation therapy) * screened for medical clearance for exercise testing and participation in vigorous aerobic exercise * residing in a commutable area near edmonton, alberta * willing to commute to the behavioural medicine fitness centre three times per week to attend a 12-week supervised high-intensity aerobic interval exercise program exclusion criteria: * having comorbidities or uncontrolled medical conditions that their referred clinicians indicate as inappropriate to participate in exercise (e.g., known cardiac disease or uncontrolled hypertension) * having contraindications for cardiopulmonary stress and/or physical fitness tests * currently participating in a structured, vigorous exercise program.

Keywords: prostate cancer active surveillance exercise high-intensity interval training randomized controlled trial
efficacy of different densities of fractional carbon dioxide in treatment of post burn scars

Conditions: Scar

Summary: this study aims to compare effectiveness of different densities of carbon dioxide fractional laser in the treatment of postburn scar.

the study included 25 egyptian patients with burn scars recruited from the out patient clinic, dermatology department, cairo university. each has three post burn scars, assigned to monthly fractional carbon dioxide laser sessions with a total of 3 sessions. parameters are : lesion a or part a parameters: 20 w, 800-1000μs dwell time, 2 to 3 stacks according to scar thickness, 900µm spacing (7.4% density). lesion b or part b parameters: 20 w, 800-1000μs dwell time, 2 to 3 stacks according to scar thickness, 600µm spacing (12.6% density). lesion c or part c parameters: 20 w, 800-1000μs dwell time, 2 to 3 stacks according to scar thickness, 300 µm spacing (25.6% density). 3 mm punch biopsy is taken before and one month after last session for assessment of collagen via (masson's trichrome strain). in addition clinical evaluation is done via vancouver \& patient and observer scar assessment scale .

Eligibility criteria:
inclusion criteria: * • burn scars of at least 1 year duration. * patients with three separate lesions each of them about 2 to 5cm or patients with single lesion equal or more than 8 to 10cm. exclusion criteria: * • pregnancy. * lactation. * oral retinoid drugs within the past 6 months.

Keywords: fractional laser postburn scar density
post-marketing surveillance to assess the safety of infanrix-ipv vaccine among infants and children in korea

Conditions: Acellular Pertussis; Diphtheria; Tetanus; Poliomyelitis; Diphtheria-Tetanus-acellular Pertussis Vaccines

Summary: the purpose of this study is to collect safety information following routine vaccination with infanrix-ipv among infants and children in korea.


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that their parent(s)/legally acceptable representative(s) can and will comply with the requirements of the protocol. * korean male or female subjects who are eligible for the primary and/or booster doses of infanrix-ipv according to the korean prescribing information. * written or signed informed consent obtained from the parent(s)/ legally acceptable representative(s) of the child. where parent(s)/ legally acceptable representatives are illiterate, the consent form will be countersigned by an impartial witness. prior to enrollment of the subject into the post-marketing surveillance, the subject's parents/legally acceptable representatives will be requested to provide information regarding the enrollment of their child in a same/similar study previously. and prior to obtaining informed consent form, the investigator will check whether the subject is eligible for vaccination. exclusion criteria: * at the time of post-marketing surveillance (pms) entry, the contraindications and precautions of use indicated in the local prescribing information should be checked and the subject must not be included in the pms if there is any contraindication. any changes in the locally approved prescribing information must be implemented immediately. * subjects who receive any investigational or non-licensed dtpa-ipv vaccine within 30 days prior to study start will not be enrolled. * child in care.

Keywords: safety infanrix-ipv post-marketing surveillance diphtheria, tetanus, pertussis and poliomyelitis