Kornimate/medical-research-clean huggingface dataset:
danicopan early access program

Conditions: Paroxysmal Nocturnal Hemoglobinuria; PNH; Extravascular Hemolysis

Summary: this is an eap, designed to provide early access to danicopan for participants with pnh experiencing clinically significant evh who have failed, not tolerated, or are unable to receive other approved treatments; in the treating physician's opinion, the participant is not eligible for or is not able to participate in an ongoing clinical trial of danicopan or a comparable treatment; and according to the treating physician, the benefit of danicopan treatment outweighs the potential risks.


Eligibility criteria:
key inclusion criteria * male or female, aged 18 years and older * diagnosed with pnh with clinically significant evh as defined by anemia (hgb ≤ 9.5 g/dl) with absolute reticulocyte count ≥ 120 × 109/l. * currently receiving treatment with soliris® or ultomiris® for at least 6 months prior to initiation of danicopan treatment. * platelet count ≥ 30,000/µl without the need for platelet transfusions. * absolute neutrophil counts ≥ 500/µl. * vaccinated against n meningitidis. key exclusion criteria * participants who are nursing or pregnant (or women who are planning to become pregnant during treatment with danicopan). * laboratory abnormalities at screening, as follows: * alanine aminotransferase (alt) \> 2 × upper limit of normal (uln) * direct bilirubin \> 2 × uln, with the exception of: * participants with increased bilirubin due to evh in the opinion of the treating physician or * participants with documented gilbert's syndrome * active bacterial or viral infection, a body temperature \> 38°c on 2 consecutive daily measures, evidence of other infection, or history of any febrile illness within 14 days prior to initiating danicopan treatment.

Keywords: paroxysmal nocturnal hemoglobinuria pnh component 5 inhibitors c5i intravascular hemolysis ivh anemia evh extravascular hemolysis
a study to evaluate and compare injections of autologous dermal and epidermal cells into the balding scalp of subjects with hair loss (ca-0004541)

Conditions: Androgenetic Alopecia; Male Pattern Baldness; Female Pattern Baldness

Summary: the purpose of this study is to evaluate the ability of injections of ji gami(tm) n and ji gami(tm) ndo to induce hair growth in male and female subjects with hair loss.


Eligibility criteria:
inclusion criteria: * male and female volunteers 18 to 65 years old, inclusive * hair loss consistent with ≥ grade iii-vertex, iv, va, v, and vi, based on norwood-hamilton scale providing there is bridging of hair in the anterior edge of the vertex circle. * able to provide informed consent after risks and benefits of the study have been explained. * be willing to undergo all study procedures. * ability to communicate effectively with study personnel. * have no clinically significant disease or abnormal laboratory evaluations taken at the screening visit. * agree to abstain from use of any hair growth affecting oral or topical medication including over the counter and herbal medications, minoxidil, finasteride or dutasteride during the course of this study. exclusion criteria: * known sensitivity to dmem/f-12 or any component of the study material. * known hypersensitivity to clindamycin hydrochloride, amphotericin b or streptomycin sulfate. * subjects who have used minoxidil or any oral or topical medication including over the counter and herbal medications for the treatment of hair loss within 6 months of study screening, or finasteride or dutasteride within 12 months of study screening. * a history of drug or alcohol abuse within 1 year of study enrollment. * participation in any other investigational study within 30 days or six half lives of its biologic activity, whichever is longer, before the scalp excision visit(s), and during the time enrolled in this study. * clinically significant medical or psychiatric illness currently or within 30 days of study screening as determined by the investigator. * clinically significant abnormal laboratory parameters. * a positive result at screening for human immunodeficiency virus (hiv 1 or 2), hepatitis b or c, htlv i/ii. * clinically significant dermatologic condition in donation or study areas. * prior surgery in the donor or study areas. * insufficient hair or scarring in the donor area that might impact cell growth. * any disease or condition (medical or surgical) that, in the opinion of the investigator, might compromise hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system function; or any condition that would place the subject at increased risk.

Keywords: androgenetic alopecia male pattern baldness female pattern baldness hair loss baldness
a pilot study of activated t cell therapy for refractory/relapsed neuroblastoma

Conditions: Neuroblastoma

Summary: activated t cell were manufactured through in vitro t cell expansion of autologous t cell. we designed this study to determine the feasibility and safety of activated t-lymphocyte cell therapy for refractory/relapsed neuroblastoma patients.


Eligibility criteria:
inclusion criteria: * informed consent * age 21 years or younger * histologically confirmed neuroblastoma * progressive disease after standard treatment or relapsed patient * ecog scale (ecog-ps) ≤2 * expected survival at least 3 months exclusion criteria: * patients with autoimmune disease * patients with immunodeficiency * other malignancy 5 year prior to this study * severe organ dysfunction * severe allergic disease * severe psychiatric disorder * pregnancy or lactating woman

Keywords: refractory/relapsed neuroblastoma patients
phase angle and chronic intestinal inflammatory diseases

Conditions: Inflammatory Bowel Diseases; Mucosal Inflammation; Leukocyte L1 Antigen Complex; C-Reactive Protein

Summary: phase angle (pha) is a biometric parameter measured by bioimpedance analysis (bia), which reflects organism cellularity and tissues hydration. in addition, since it correlates with the presence of inflammation and the nutritional status, it could be useful to monitor inflammatory bowel disease (ibd) activity. the aim of this study was to establish the potential use of pha as a new non-invasive and sensitive marker correlated with mucosal healing and/or ibd activity.

currently, fecal calprotectin is considered the best indirect marker inversely correlated with the mucosal healing in patients with inflammatory bowel disease (ibd). c reactive protein (crp), is less reliable than fecal calprotectin in the evaluation of ibd activity. in order to establish the potential use of phase angle (pha) as a new non-invasive and sensitive marker of mucosal healing and/or disease activity in patients with ibd, patients with diagnosis of chronic inflammatory bowel diseases (ibd) according to the european crohn's and colitis organization (ecco) guidelines will be enrolled. in these patients, the following parameters will be evaluated: age, sex, body mass index (bmi), percentage of weight loss in the last 6 months, duration of illness, location of disease, any previous intestinal surgery, ongoing therapy for ibd, activity disease by clinical scores, crp, fecal calprotectin, disease activity by endoscopic scores, pha and fat free mass (ffm).

Eligibility criteria:
inclusion criteria: * histological report confirming the diagnosis of ibd, * value of c-reactive protein (crp) * fecal calprotectin, * colonoscopy within 3 months from the enrollment. exclusion criteria: * presence of ascites or edema, * chronic or autoimmune inflammatory diseases, * ongoing infections, * recent surgery (in the last 6 months), * neoplastic diseases, * ongoing enteral or parenteral nutrition, * presence of fistulae, * ileostomy or colostomy, * short bowel syndrome, * pregnancy or lactation.
the safety and efficacy of gefapixant (af-219/mk-7264) in female participants with interstitial cystitis /bladder pain syndrome (mk-7264-005)

Conditions: Bladder Pain Syndrome

Summary: the purpose of this study is to assess the efficacy of gefapixant (af-219/mk-7264) in female participants with moderate to severe pain associated with interstitial cystitis/bladder pain syndrome (ic/bps) after 4 weeks of treatment.

this study is a double-blind, placebo-controlled, randomized trial designed to assess the efficacy and safety of gefapixant in female participants with moderate to severe pain associated with ic/bps. the study will consist of 4 phases: screening, baseline, treatment, and follow-up.

Eligibility criteria:
inclusion criteria: * women * women of child bearing potential must not be pregnant during the study and must use two forms of birth control * clinical evidence of interstitial cystitis /bladder pain syndrome (ic/bps) * have provided written informed consent exclusion criteria: * history of diseases that can be confused for ic/bps * unable to void spontaneously * immunosuppressant, intravesicular, nerve stimulator or opioid treatment for certain periods prior to start of the study * changes to doses of elmiron®, antidepressant, alpha-adrenergic antagonist, h1 antagonist, or anti-muscarinic treatment within a certain period prior to the start of the study
re-rehabilitation in chronic obstrctive pulmonary disease

Conditions: Copd; Smoking; Smoking Cessation; Rehabilitation; Tobacco Use

Summary: patients with copd who participated in the second rehabilitation program in the pulmonary rehabilitation unit will be included in the study. pulmonary function tests, arterial blood gases, mmrc dyspnea perception, 6-minute walking distance, disease-specific (sgrq) quality of life and hospital anxiety depression scale values will be compared.

pulmonary rehabilitation (pr) program in patients with copd reduces dyspnea perception, increases exercise capacity, improves quality of life, and reduces psychological symptoms. unfortunately, these gains are not permanent, but disappear within 12-24 months. the aim of this study is to compare the gains of the second pr program with the first program. patients with copd who participated in the second rehabilitation program in the pulmonary rehabilitation unit will be included in the study. pulmonary function tests, arterial blood gases, mmrc dyspnea perception, 6-minute walking distance, disease-specific (sgrq) quality of life and hospital anxiety depression scale values will be compared.

Eligibility criteria:
inclusion criteria: * above 18 years * completed pr program exclusion criteria: -

Keywords: copd smoking smoking cessation rehabilitation; tobacco use
effect of tea tree oil and coconut oil on nipple crack formation

Conditions: Nipple Infection

Summary: the aim of the study was to determine the effect of tea tree oil and coconut oil applied to the nipples during the early postpartum period on nipple crack formation.

this randomized controlled experimental research included a total of 90 women in the research sample abiding by the research criteria, with 30 each in the intervention groups (coconut oil or tea tree oil application) and 30 in the control group. women in the intervention groups applied coconut oil or tea tree oil to the nipples on the 3rd, 7th and 10th days postpartum, while the control group did not have any intervention

Eligibility criteria:
inclusion criteria: * mothers who volunteered for participation, h * aged from 18-45 years, * with new and live birth after 37 weeks, * without flat or small nipple problems, * without previous breast operations, * able to apply correct breastfeeding methods and with infants with birth weight of 2500 g and above were included in the study. exclusion criteria: * mothers who could not breastfeed, * had stillbirth, * who had infants with congenital anomalies preventing breastfeeding were not included in the study.
combined molecular testing for influenza, sars-cov-2, and rsv rna from different upper airway specimens.

Conditions: Influenza; COVID-19; RSV Infection

Summary: this is a comparative prospective diagnostic accuracy study reported according to the stard guidelines. citizens at an outpatient covid19 test facility at testcenter danmark valby will be invited to participate in the study on a volunteer basis. the enrolled participants will have the planned oropharyngeal swab performed in the test center and sent for a sars-cov-2 rt-pcr test at testcenter danmark, statens serum institut, copenhagen, denmark as usual. besides the planned oropharyngeal swab performed in the test center, the participants will have additional specimens collected in form of saliva, nasopharyngeal-, nasal-, and oropharyngeal swabs. these will all be used for the detection of nucleic acids from the four most common strains of influenza (b yamagata, b victoria, a h1n1 and a h3n2), sars-cov-2 and rsv a/b. further we will measure immune mediating cytokines, chemokines, and interleukins in the different specimens. these analyses will be performed at technical university of denmark (dtu).


Eligibility criteria:
the inclusion criterion: a. 18 years or more of age requiring a test for covid-19. the exclusion criteria are : a. neck breathers (tracheostomy/laryngectomy patients) or other nasopharyngeal or oropharyngeal anomalies that do not allow for sampling using swabs. b. do not understand oral or written danish
safety and pharmacokinetic study of omt-28 in healthy subjects

Conditions: Healthy Volunteers

Summary: the aim of this first-in-human study is to assess the safety, tolerability, pk and exploratory pharmacodynamics (pd) of single and multiple oral ascending doses of omt-28 in healthy male subjects to support further clinical development of omt-28 in the indication of atrial fibrillation (af) and to obtain data on food and gender effects of omt-28 to guide dosing for phase ii trials.

this first-in-human study will be carried out in one study center involving multiple steps. up to 100 healthy male and female subjects will be enrolled. the study consists of 4 parts: 1. a single ascending dose (sad) part 2. a multiple ascending dose (mad) part 3. a single dose, double cross-over food effect (fe) part. 4. a single dose gender effect part (female subjects group) the safety and pk data will be evaluated by the dsmc after each cohort to decide on further dose escalation.

Eligibility criteria:
inclusion criteria: 1. in general good physical health as determined by medical and surgical history, physical examination, 12 lead ecg, vital signs, and clinical laboratory tests 2. normal blood pressure (systolic blood pressure (sbp) between 100 to 140 mmhg (both inclusive); diastolic blood pressure (dbp) ≥55, ≤89 mmhg) measured after 5 min rest in supine position. 3. sad, mad, and fe part: male of 18 to 45 years (inclusive) of age. 4. gender effect part: female of 18 to 45 years (inclusive) of age. exclusion criteria: 1. more than moderate smoker (\> 10 cigarettes/day). 2. more than moderate alcohol consumption (\> 35 g of ethanol regularly per day or \> 245 g regularly per week). 3. use of any medication 4. one or more key safety laboratory parameters out of normal range gender effect part pregnant or breastfeeding women and of childbearing potential previous assignment to treatment during this study.

Keywords: omt-28 atrial fibrillation sad mad first-in-man cardiovascular
efficacy of interferential laser therapy in shoulder pain

Conditions: Shoulder Musculoskeletal Disorders

Summary: the purpose of this study is to determine the advantages of the interferential laser therapy in shoulder pain reduction compared with the conventional low level laser therapy modality.

the spatiotemporal superposition of two independent and opposite beams of laser generates a constructive interference pattern that increases the therapeutic effects in the irradiated tissue. patients diagnosed of shoulder pain from different musculoskeletal disorders will received conventional or interferential laser therapy. this is a comparative, randomized and double - blind clinical study. two identical equipments of near infrared laser therapy will be used. number of sessions: 15. frequency of the sessions: daily. irradiation technique: manual, contact and punctual.pain will be evaluated by visual analog scale (vas) at rest and during analytical shoulder movements (abduction, adduction, internal rotation, external rotation, flexion, extension) and by means of a pain and disability index (spadi). evaluations will take place at pre and post treatment.

Eligibility criteria:
inclusion criteria: * acute or chronic pain from musculoskeletal origin * age between 18 and 70 years exclusion criteria: * brachial plexus palsy * neurological diseases * pacemakers * shoulder pain from cervical pathology * osteosynthesis material * fibromyalgia

Keywords: interferential laser therapy
clinical trial of 4% niacinamide versus 0.05% desonide for the treatment of axillar hyperpigmentation

Conditions: Hyperpigmentation

Summary: axillary hyperpigmentation is a frequent consultation in dark skin populations although its exact prevalency is unknown. currently, there are not studies about physiopathology and treatment for this entity. the objective is to evaluate the depigmenting effect of topical 4% niacinamide versus 0.05% desonide in axillary hyperpigmentation. at least 30 axillas with hyperpigmentation in individuals of phototype iii-v, aged 18-50 years are going to be randomly assigned to receive niacinamide, desonide or placebo daily. no hygienic habits will not be modified. volunteers will be evaluated at baseline and for 9 weeks, by means of histological, histochemical and immunohistochemistry analysis, as well as transepidermal water loss (tewl), colorimetry, clinically and by photography control.

axillary hyperpigmentation is frequent in dark skin population, is possible a type of postinflammatory hyperpigmentation present in phototypes iv to vi. previous reports have described increased intensity of masson-fontana, anti-tyrosinase and/or anti-trp1 staining, indicative of melanocyte stimulation and increased melanin production, but the exact mechanism is unknown. the hair plucking, the rubbing of clothes on skin and physical stimulation from washing and drying the underarm are factors implicated. the objective of our study is evaluate the depigmenting effect of topical niacinamide versus desonide in axillary hyperpigmentation through the histochemistry and immunohistochemistry staining. the study population will include at least 30 axillas with hyperpigmentation in a population with phototype iii-v and aged 18-50 years old. informed consent will be obtained from the patients, under approval by the local ethical committee (institutional review board). the patients are going to be randomly assigned to receive 4% niacinamide, 0.05% desonide or placebo daily once at night. none hygienic habit is going to be modified. volunteers will be evaluated at baseline and 9 weeks later, with histochemical and immunohistochemical analysis (biopsies), colorimetric value axis l\*, a\*, b\* (chromameter cr-300, minolta, osaka, japan), transepidermal water loss (tewl) by means of an evaporimeter (dermalab, cortex technology, denmark), clinical assessment and photography control. statistical analysis was performed using t student, the level of significance was set at 5%. and clinical evaluation will be analysed by means of chi square test.

Eligibility criteria:
inclusion criteria: * women over 18 years old * healthy * clinical diagnosis of axillar hyperpigmentation exclusion criteria: * pregnancy or lactation * obesity * endocrinological diseases * mental diseases * treatment for axillar hyperpigmentation in the last 2 months

Keywords: inflammatory hyperpigmentation, axillar pigmentation
the impact of playing tetris on migrants' mental health

Conditions: Post-traumatic Stress Disorder (PTSD); Anxiety Symptoms; Depression Symptoms

Summary: this study examines if playing tetris prevents the development of post-traumatic stress disorder or related anxiety and depressive symptoms. the investigators recruit 300 participants in total in greece and in the netherlands. the participants are immigrants who have applied for asylum at any point in the past. the participants are asked to answer three questionnaires (on post-traumatic stress disorder, related anxiety and depressive symptoms, and post-migration living difficulties) on a recurring basis - once every 4 weeks, 12 times in total. half of the participants (treatment group) are randomly selected to play tetris after completing the questionnaires. participants in the treatment group are instructed to play tetris for at least 15 minutes while trying to remember bad things that recently happened to them. tetris is administered at three instances and participants in the treatment group are encouraged to play tetris in case of experiencing any traumatic events or having any intrusive memories during the course of the study.


Eligibility criteria:
inclusion criteria: * arabic-speaking immigrants of any gender who have applied for asylum in greece or in the netherlands, regardless of the outcome of their asylum application and their current residency status (rejected asylum seekers, recognized refugees, undocumented migrants). exclusion criteria: * minors (under the age of 18).

Keywords: post-traumatic stress disorder ptsd anxiety depression refugees asylum seekers migrants tetris longitudinal