Kornimate/medical-research-clean huggingface dataset:
danicopan as add-on therapy to a c5 inhibitor in paroxysmal nocturnal hemoglobinuria (pnh) participants who have clinically evident extravascular hemolysis (evh)(alpha)

Conditions: Paroxysmal Nocturnal Hemoglobinuria

Summary: the main objective of this study is to evaluate the efficacy of danicopan as add-on therapy to a complement component 5 (c5) inhibitor (eculizumab or ravulizumab) in participants with pnh who have clinically evident evh.

this is a multiple-region, randomized, double-blind, placebo controlled, multiple-dose, study in participants with pnh who have clinically evident evh on a c5 inhibitor (eculizumab or ravulizumab). participants will be randomized to receive danicopan or placebo, in a 2:1 ratio for 12 weeks (treatment period 1) in addition to their c5 inhibitor (eculizumab or ravulizumab) therapy. at week 12, participants randomized to receive placebo will be switched to danicopan in addition to their c5 inhibitor for an additional 12 weeks (treatment period 2) and participants randomized to danicopan will continue on danicopan for an additional 12 weeks, while remaining on their ongoing c5 inhibitor therapy. at the end of the 2 treatment periods (week 24), participants may enter a long-term extension (lte) period and continue to receive danicopan in addition to their c5 inhibitor therapy. the long-term extension period will consist of a first year of lte(year1) and a second year of optional lte(year2).all patients will complete 72 weeks of lte(year 1) assessments. after week 72 (at the end of the first year of lte), patients have the choice to complete participation in this study or continue to the optional second year (year2) of lte.

Eligibility criteria:
inclusion criteria: * diagnosis of pnh * clinically evident evh defined by: * anemia (hgb ≤9.5 gram/deciliter) with absolute reticulocyte count ≥120 x 10\^9/liter * receiving an approved c5 inhibitor for at least 6 months prior to day 1 * platelet count ≥30,000/microliters (µl) * absolute neutrophil counts ≥500/μl * documentation of/or willingness to receive vaccinations for n. meningiditis and prophylactic antibiotics as required exclusion criteria: * history of a major organ transplant or hematopoietic stem cell transplantation (hsct) * participants with known aplastic anemia or other bone marrow failure that requires hsct or other therapies including anti-thymocyte globulin and/or immunosuppressants * known or suspected complement deficiency * laboratory abnormalities at screening, including: * alanine aminotransferase \>2 x uln (\>3 x uln in case of patients with documented liver iron overload defined by serum ferratin values * 500 ng/ml) * direct bilirubin \>2 x uln (unless due to evh or documented gilbert's syndrome) * current evidence of biliary cholestasis * estimated glomerular filtration rate of \<30 milliliters/minute/1.73 meter squared and/or are on dialysis * evidence of human immunodeficiency virus, hepatitis b, or active hepatitis c infection at screening

Keywords: paroxysmal nocturnal hemoglobinuria (pnh) extravascular hemolysis (evh) factor d inhibitor complement danicopan c5 inhibitor
the effects of labor stages and interventions on hemodynamic measures during & after childbirth with noninvasive sensors

Conditions: Rupture of Membranes; Premature; Cesarean Section; Infection; Preeclampsia

Summary: the effects of labor stages and interventions on hemodynamic measures during and after childbirth ( epidural, rupture membranses cesarean sections and preeclampsia) with noninvasive sensors.


Eligibility criteria:
inclusion criteria: * pregnant woman between 18-45 years old * with non cardiovascular disease exclusion criteria: * woman with a cardiovascular disease * woman who don't agree to participate in the trial
the impact of sinopharm covid-19 vaccination on male fertility

Conditions: Male Infertility; Hypogonadism, Male

Summary: the investigators shall study the effect of sinopharm vaccination on semen parameters and serum testosterone

the investigators shall compare semen parameter (sperm density, sperm motility, and percentage of abnormal sperm form) as well as morning serum testosterone before vaccination, and 3 months after the second dose of the vaccine.

Eligibility criteria:
inclusion criteria: receiving sinopharm covid-19 vaccines male age 18-50 years old exclusion criteria: * adults unable to consent * men who have been receiving testosterone replacement therapy or anabolic steroids within the last year * men with a history of male infertility * men with a genetic or other medical condition known to be associated with decreased semen parameters positive covid-19 pcr test within the 3 months
perception of unpleasant sensations during study procedures in als patients

Conditions: Amyotrophic Lateral Sclerosis

Summary: diagnosis of amyotrophic lateral sclerosis (als) is considered a traumatic life event for both the patient and their next-of-kin/carers, due to the lack of treatment. clinical trials can offer pioneering treatment to reduce the impact of the disease and improve future treatments worldwide. research protocols may involve routine diagnostic and/or therapeutic procedures which the patients may be already aware of and, therefore, expecting specific sensations. these could compromise participation or drop-out rate. despite everything, participation in a clinical trial can guarantee continuity of care also thanks to the execution of these same procedures, through preferential access compared to other patients. aim of this study is to investigate the unpleasant sensations perceived by als patients during procedures in clinical trials. analysing what type of pain/discomfort frightens patients during diagnostic and/or therapeutic procedures, including the different methods of administration of the study drug. provide data to implement effective therapy and offer constant patients support throughout als specific and needed procedures. evaluate if this support could influence adherence rate of als patients to conduct clinical trials as required. provide information for future studies to create an als clinical trials multiple-retention-factors adherence scale. create and implement an als-specific pain scale accounting for its impact on daily activities, aiding an interdisciplinary approach of pain management. identify the best pain management strategies and compliance techniques to address als, not merely in clinical trials. provide the best individualized care for als patients improving their quality of life and mental state. this is a descriptive phenomenological study and data will be analyzed according to sundler's method. based on the experience of the researchers and the recommendations proposed by sandelowski, a total of 20 interviews are estimated in order to reach the theoretical saturation per category of reference. data collection will be carried out through in-depth semi-structured interviews recorded (13 open-ended questions after the execution of the procedures).


Eligibility criteria:
inclusion criteria: * spinal or bulbar amyotrophic lateral sclerosis (als) * age \> 18 years * adequate understanding of italian language * full understanding of the study * informed consent signed * current or past participation in interventional clinical studies * amyotrophic lateral sclerosis functional rating scale (alsfrs) score of item # 4 ≥ 2, or score of item #1 ≥ 1 exclusion criteria: * clinically relevant cognitive dysfunction * inability to answer orally or by writing to the questions of the interview * hospital anxiety and depression scale (hads) scale ≥ 11

Keywords: study procedures
embo registry; national registry for artery embolization

Conditions: Chronic Pain; Osteoarthritis, Knee; Osteoarthritis Thumb; Osteoarthritis Shoulder; Pain, Chronic; Tendonitis Elbow; Tendonitis Shoulder; Tendonitis;Achilles; Tenosynovitis

Summary: embo registry is a retrospective and prospective observational study to evaluate real world effectiveness and the use of artery embolization as a treatment for chronic pain with patients that have osteoarthritis and localized pain to provide symptomatic relief. this study is to determine the efficacy and validity of procedure and that following procedure patients had decreased pain and improved quality of life.

embolic solution are intended for use in occluding blood vessels for therapeutic or operative purposes. the embolic solution is used during an outpatient procedure, the physician will insert a small catheter onto the artery supplying the lining of the target joint or target localized pain. tiny particles are then injected through the catheter into these arteries, reducing blood flow to the target area. this reduces the amount of inflammation associated with osteoarthritis, tendonitis, tenosynovitis or an injury, a process that can help decrease symptoms or eliminate the associated localized pain to this area. with understanding that it does not treat the underlying cartilage destruction or underlying condition causing pain but would like to determine the efficacy and validity of this treatment. for the study to determine efficacy and overall improvement of patients post procedure by comparing patient's pain preoperative and post operatively, if there is a decreased use of medication preoperatively compared to post procedure and increased quality of life preoperative and post procedure. clinical outcomes of improvement will be determined by improvement of visual analog scale (vas) scores, western ontario and mcmaster universities index (womac), eq-5d-5l quality of life questionnaire, and to determine if patients had decrease used of medication prescribed preoperatively.

Eligibility criteria:
inclusion criteria: * \> 18 years of age undergone artery embolization interventions for the treatment of chronic pain due to osteoarthritis or other diagnoses that cause localized pain. exclusion criteria: * none

Keywords: pain osteoarthritis arthritis tendonitis tenosynovitis
cognitive-behavioural therapy as a preventive treatment for post traumatic stress disorder

Conditions: Post Traumatic Stress Disorder

Summary: this study will examine the use of modified prolonged exposure therapy in trauma patients recently exposed to trauma in an emergency room to prevent the onset of post-traumatic stress disorder.

this study investigates if prolonged exposure is an effective treatment in reducing ptsd symptoms people who have recently experienced trauma. the study will also investigate predictive markers of ptsd, moderators of successful treatment and health economic aspects of the intervention. participants will first undergo an evaluation session that will include an interview (immediate stress reaction checklist) and questionnaires. participants will subsequently be randomly assigned to receive either modified prolonged exposure therapy or attention control, starting the assigned intervention immediately. participants in each arm will receive three weekly treatment sessions. treatment will involve psychoeducation about common reactions to trauma, imaginal exposure (revisiting memories of a recent trauma out loud with a therapist and audio-recording these for review at home), exposure in vivo and breathing retraining. all participants will undergo assessments 2, 6 (primary endpoint) and 12 months after the intervention by blinded assessors. patients unable to come to the clinic for follow-up assessments will be interviewed via telephone or skype. source data will be quality monitored by an independent party (karolinska trial alliance) according to the helsinki declaration.

Eligibility criteria:
inclusion criteria: * presenting to the emergency department at the karolinska university hospital solna in the past 72 hours before the intervention * meets diagnostic criterion a for post-traumatic stress disorder in the fifth version of diagnostic and statistical manual of mental disorders, dsm-5 exclusion criteria: * do not want to participate in the study * ongoing intoxication (e.g. severe alcohol intoxication) * other serious psychiatric comorbidity that demands attention (e.g. manic episode, acute suicidal ideation) * not oriented * not having a memory ot the tramatic event
evaluating the effectiveness of axiostat hemostatic dressing material versus conventional method of hemostasis and healing of extraction wounds in patients on oral anti-platelet drugs - a comparative study

Conditions: Tooth Extraction

Summary: the rationale of this study was to evaluate the efficacy of axiostat hemostatic dental dressing in achieving hemostasis post-extraction and determining its effect on pain and healing of the extraction wound, compared to control, i.e. conventional method of extraction in patients on oral anti-platelet therapy.


Eligibility criteria:
inclusion criteria * patients undergoing multiple tooth extractions aged b/w 35- 70 years and with inr values ≤ 3.5 (1-3.5) * if present, sugar level should be under control exclusion criteria * patients undergoing a single tooth or multiple extractions in same quadrant; and those with an allergy to seafood.
study to look at benefit of surgical drainage before beginning medical therapy for crohns perianal fistulas

Conditions: Crohns Disease; Fistula; Abscess

Summary: this study is looking at the advantage of establishing surgical drainage for crohn's fistulas and abscesses prior to starting medical therapy.

currently the importance of surgically established drainage of crohn's perianal fistulas prior to medical therapy is controversial. several retrospective studies have suggested a benefit to this approach. (1, 2) however, there have been no prospective studies performed to answer this important question. this study aims to definitively answer this question. our hypothesis is that by establishing surgical drainage of all perianal fistulas and abscesses prior to initiation of medical therapy, further abscess formation will be prevented and the rate of durable fistula healing will improve.

Eligibility criteria:
inclusion criteria: * male and female aged 18 years or older; * a confirmed diagnosis of crohn's disease and one or more identifiable perianal fistulas; * patient's standard of care treatment plan includes the following options: a) surgical intervention with an exam under anesthesia (eua) by colorectal surgeon, seton placement and drainage of fistula prior to initiating certolizumab or b) initiating certolizumab without surgical intervention; * patient has had recent colonoscopy to determine disease activity and extent; and * patient has had either rectal eus or pelvic mri (type of test based on investigator site preference) which has identified one or more perianal fistulas. exclusion criteria: * any of inclusion criteria is not met; * females who are pregnant or breast feeding; * anti-tnf use within 6 weeks prior to study entry; * patients who cannot take, or refuse to take concomitant immunosuppressive therapy with either azathioprine, 6-mercaptopurine, or methotrexate; unless patient has been intolerant of these therapies in the past or is contraindicated as determined by the investigator. * patients who cannot take, or refuse to take concomitant antibiotic therapy; * patients with severe anal stenosis or tenderness which would preclude colonoscopy and / or rectal eus; * patients who cannot take or refuse to take certolizumab; * patients with active or latent tuberculosis; * patients who have had systemic antibiotic, antiviral or antifungal treatment(s) within 3 weeks prior to screening for all non-crohn's related infections; * patients concurrently taking anakinra (kineret); * patients with a history of cancer or lymphoproliferative disease other than a successfully and completely treated cutaneous squamous cell or basal cell carcinoma or carcinomain-situ of the cervix; * patients with chronic hematologic problems such as bleeding dyscrasias; * patients with a history of demyelinating disease (i.e. multiple sclerosis); and * patients with congestive heart failure

Keywords: crohns fistula perianal abscess perianal
study to evaluate the efficacy and safety of minocycline in angelman syndrome

Conditions: Angelman Syndrome

Summary: randomized clinical trial, placebo compared to evaluate the efficacy and safety of minocycline in angelman syndrome (a-manece study)

study to evaluate the efficacy and safety of minocycline in angelman syndrome

Eligibility criteria:
inclusion criteria: * male or female between 6 and 30 years old. * clinical diagnosis of angelman syndrome and molecular confirmation of diagnosis. * the participant has an acceptable guardian can give consent on behalf of the participant. exclusion criteria: * patients with hypersensitivity to tetracyclines. * patients with impaired hepatic or renal function and in those with mainly drug allergy history. * any other condition that in the opinion of the investigator is considered clinically relevant and that administration of minocycline contraindicated

Keywords: angelman syndrome efficacy safety minocycline pediatrics population rare diseases
follow-up study using gene therapy for critical limb ischemia (nl003-cli-iii-l)

Conditions: Peripheral Arterial Disease(PAD); Arterial Occlusive Disease; Arteriosclerosis Obliterans; Thromboangiitis Obliterans; Diabetic Foot Ulcer (DFU); Diabetic Foot Ulcer Ischemic; Critical Limb Ischemia (CLI)

Summary: the goal of this observational study is to learn about the long-term effects of donaperminogene seltoplasmid injection (nl003) in participants who have been received drug nl003 or placebo at least one dose from the parent phase iii clinical study to treat their critical limb ischemia (cli). the main questions it aims to answer are: * first, what medical problems do participants have after taking drug nl003 to treat cli? * second, does drug nl003 make cli participants live longer without serious problems (amputations or target vessel revascularizations) ? participants who have already received drug nl003 for cli will complete online surveys about their health conditions. this study will continue until at least 36 months after the participant's first dose.

this study is a multicenter, open-label, long-term follow-up cohort study. a remote follow-up system is recommended as a tool for the study, however, in-person visits or phone calls at the research center will be conducted if remote follow-up is not feasible. the study will retrospectively collect data from the last visit in the parent phase iii study and prospectively gather data following informed consent. it will continue until at least 36 months after the first dose administered to the last enrolled participant.

Eligibility criteria:
inclusion criteria: * participants who have previously enrolled in phase iii clinical trials of recombinant human hepatocyte growth factor plasmid injection (donaperminogene seltoplasmid injection) for the treatment of critical limb ischemia (including ulcers and rest pain) and have received at least one dose of the treatment. exclusion criteria: * participants who refused to provide written informed consent; * participants who refused to cooperate with the retrospective or prospective data collection.

Keywords: hgf critical limb ischemia gene therapy
masitinib in non-resectable or metastatic stage 3/4 melanoma carrying a mutation in the juxta membrane domain of c-kit

Conditions: Metastatic Melanoma

Summary: the objective is to assess the efficacy and safety of masitinib at 7.5 mg/kg/day in the treatment of patients with non-resectable or metastatic stage 3 or stage 4 melanoma carrying a mutation in the juxta membrane domain of c-kit and who have not previously been treated for melanoma.

masitinib is a selective tyrosine kinase inhibitor with potent activity against the juxta membrane domain of c-kit. masitinib is also thought to promote survival via modulation of immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment. the objective of this study was to evaluate the efficacy and safety of masitinib with respect to dacarbazine in the treatment of non-resectable or metastatic stage 3 or stage 4 melanoma carrying a mutation in the juxta membrane domain of c-kit. following a protocol amendment, the dacarbarzine treatment group was closed and recruitment restricted to masitinib treatment of chemo-naïve (first-line) patients.

Eligibility criteria:
main inclusion criteria include: * patient with histologically or cytologically confirmed non-resectable or metastatic stage 3 (non-resectable iiib or iiic, ajcc tnm staging system 7th edition) or stage 4 melanoma * patient with detectable c-kit jm mutation (mutation in exon 9, 11 or 13) confirmed by dna or rna sequencing, which is expected to be mainly found after screening of mucosal or acral melanoma or melanoma on skin with chronic sun-induced damages (defined by a microscopically marked elastosis involving the skin surrounding their primary melanoma). * patient not previously treated for melanoma (first-line) main exclusion criteria include: * pregnant, or nursing female patient * patient with active brain metastases. * prior treatment with a tyrosine kinase c-kit inhibitor

Keywords: melanoma tyrosine kinase inhibitor c-kit juxta membrane mutation
surgicel® fibrillar for delayed bleeding after esd

Conditions: Benign Neoplasm of Stomach; Malignant Neoplasm of Stomach

Summary: the aim of this study is to assess the effect of surgicel® fibrillar as adjuvant treatment to h2ra on preventing ulcer bleeding after esd for gastric epithelial tumors

1. patient (1) inclusion: diagnosed as gastric dysplasia or early gastric cancer * scheduled for esd (2) exclusion: coagulopathy- liver cirrhosis, thrombocytopenia * anti-platelet agents 2. method (1) study group: combination with surgicel® fibrillar and h2ra (2) control group: monotherapy with ppi 3. sample size : 157 4. result 1. primary endpoint: rate of delayed bleeding after esd 2. secondary endpoint: follow-up hemoglobin after esd

Eligibility criteria:
inclusion criteria: * esd for gastric dysplasia or early gastric cancer exclusion criteria: * coagulopathy: liver cirrhosis, thrombocytopenia * anti-platelet agents
ultrasound-guided neuromodulation percutaneous in lower back pain

Conditions: Lower Back Pain

Summary: in our daily clinical practice, one of the most frequent reasons for consultation physiotherapists is low back pain (lbp). regardless of the origin of the problem, the approach from physiotherapy contemplates the reduction of pain through different procedures, including neuromodulation. in the field of physiotherapy, ultrasound-guided percutaneous neuromodulation (pnm) is defined as the application through a needle with ultrasound guidance of an electrical current at low or medium frequency, seeking a sensitive and / or motor response of a peripheral nerve in some point of its trajectory, or of a muscle in a motor point, with a therapeutic objective. the objective of this study is to analyze that the effect of pnm on the sciatic nerve produces statistically significant changes in pain, joint range and functionality in patients with chronic lbp. thirty subjects will be recruited, which will be divided into 3 groups: group 1 to which pnm will be applied to the sciatic nerve in the gluteus region; group 2 to which pnm will be applied to the sciatic nerve in the middle of the thigh; and group 3 to which pnm will be applied to the sciatic nerve before popliteus region. the pnm intervention with nmp will consist in the single application of an asymmetric rectangular biphasic current (250 microseconds, 3 hz) during 90 seconds


Eligibility criteria:
inclusion criteria: * diagnosis of lower back pain * having no other therapy exclusion criteria: * other pathology (discal hernia, injured limbs, neurological pathology) * belenophobia