cyrilzakka/clinical-trials huggingface dataset:
A Multicenter, Randomized, Controlled Trial of Prednisone Combined with Ursodeoxycholic Acid in the Treatment of Primary Biliary Cholangitis with Moderate to Severe Interface Hepatitis Characteristics

About 1/3 of patients with primary biliary cholangitis (PBC) exhibit moderate to severe interface hepatitis, and this group of patients have poor response to UDCA treatment. However, as it is not yet sufficient to diagnose autoimmune hepatitis or overlap syndrome, it is difficult to initiate immunosuppressive therapy such as steroids according to current guidelines. The aim of this study is to explore whether PBC patients with moderate to severe interfacial inflammation can benefit from UDCA combined with prednisone therapy, and its treatment safety.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily joining the group, able to understand and sign an informed consent form;
2. 18 years old ≤ age ≤ 75 years old;
3. The diagnosis of primary biliary cholangitis follows the AASLD international diagnostic and treatment guidelines (meeting two of the following three criteria: AMA or gp210, sp100 positive; Elevated serum ALP levels; Pathological manifestations include non suppurative cholangitis and destruction of the interlobular bile duct;
4. Liver histology suggests moderate to severe interfacial hepatitis (moderate,\&lt;50% portal or fibrous septa destruction, severe,\&gt;50% portal or fibrous septa destruction) with serum ALT\&lt;5 \* ULN, serum IgG\&lt;2 \* ULN, and negative serum anti smooth muscle antibodies;
5. Not receiving UDCA, hormone or other immunosuppressive therapy before enrollment;
6. ALP\&gt;1.67 \* ULN.

Exclusion Criteria:

* History or presence of other concomitant liver diseases.
* ALT or AST \&gt; 5×ULN, TBIL \&gt; 3×ULN.
* If female: known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating.
* Allergic to fenofibrate or ursodeoxycholic acid.
* Taking hepatotoxic drugs (e.g., dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than 2 weeks within 6 months, and long-term hormonal users.
* Recurrent variceal bleeding, poorly controlled hepatic encephalopathy or refractory ascites.
* Patients with a history of severe cardiac, cerebrovascular, renal, respiratory disease or functional failure, and psychiatric disorders (including those due to alcohol and drug abuse).
* Creatinine \>1.5×ULN and creatinine clearance \<60 ml/min.
* Currently using statins (such as pravastatin, fluvastatin, and simvastatin), other fibrates (such as gemfibrozil and bezafibrate), and drugs structurally similar to fenofibrate (like ketoprofen).
* Planned to receive an organ transplant or an organ transplant recipient.
* Needing Liver transplantation within 1 year according to the Mayo Rick score.
* Any other condition(s) that would compromise the safety of the subject or compromise
Korean Post-marketing Surveillance for Sprycel®

The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Sprycel® so that the regulatory authority can manage the marketing approval properly.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase
* Adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including Imatinib
* Adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) with resistance or intolerance to prior therapy

Exclusion Criteria:

* According to Warning/Caution in local label
Family Intervention in Recent Onset Schizophrenia Treatment (FIRST)

The primary purpose of this study is to evaluate the overall effect of caregivers receiving a study-provided caregiver psycho-education and skills training program on the number of treatment failures (psychiatric hospitalization, psychiatric emergency room (ER) visit, crisis center visit, mobile crisis unit intervention, arrest/incarceration, and suicide or suicide attempt) in patients under their care during a 12 month period.

This is a randomized, open-label, parallel group study of patients with schizophrenia, schizoaffective disorder, or schizophreniform disorder and their caregivers. Study will consist of a paired patient and caregiver. Patients will receive routine treatment, which may include oral antipsychotics or paliperidone palmitate, as directed by their treating physician. Caregivers for patients whose routine treatment is paliperidone palmitate will be randomized to receive either a study-provided caregiver psycho-education and skills training or usual caregiver support. Caregivers for patients whose routine treatment is oral antipsychotics will be randomized to the same Study Groups: Study Group 1: Study-provided caregiver psycho-education and skills training. Study Group 2: Usual caregiver support (caregiver support that is customarily provided by the study site, if any). Patients-caregiver pairs will be followed for up to 12 months following baseline assessment. Cumulative number of treatment failures over 12 months will be assessed primarily.

Eligibility Criteria:
Inclusion Criteria:

A) Caregivers

* Each caregiver 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 for the duration of the study
* Caregiver is able to have verbal interaction with the patient with schizophrenia, schizoaffective disorder, or schizophreniform disorder at least twice a week, per self-report

B) Patients

* Patients must have a clinical diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder made by a clinician with understanding of the Diagnostic and Statistical Manual of Mental Disorders (DSM V) criteria for these disorders
* Patients must be receiving ongoing psychiatric treatment at the study site and must be receiving oral antipsychotics or paliperidone palmitate long acting therapy

Exclusion Criteria:

* A) Caregivers
* Caregiver is mentally or physically incapable of adequately performing the required study procedures, as determined by the treatment team
* Caregiver has received structured or manualized psycho-education or skills training within 1 year prior to Screening B) Patients
* Patient is hospitalized (medical or psychiatric), incarcerated, or otherwise institutionalized at time of randomization
* Patient is considered to have significant potential for imminent harm to self and/or others as based on the judgment of the treatment team
* Patient is receiving assertive community treatment (ACT) or other high intensity case management services to prevent hospitalization
Study to Compare Self-administered and Nurse-administered Intradermal Influenza Vaccine

The purpose of this study is to compare the immunogenicity and reactogenicity of self-administered intradermal influenza vaccine (Intanza)to nurse-administered.

Participants will be randomized at visit one to either receive self-administered or nurse-administered intradermal influenza vaccine (Intanza). A blood sample will be taken prior to vaccination and 21 days post-vaccination. Participants will record information in a memory aid for 7 days including daily temperatures, solicited, unsolicited and general reactions. They will be called on study Day 8 to collect this information. Participants will return 21-24 days later for follow-up serology and review of adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Medically stable persons between age of 18-60
* Available during the trial period and for follow-up
* Able to read, understand, and sign informed consent
* Able to be contacted by telephone for follow-up of adverse events

Exclusion Criteria:

* Use of experimental vaccines within the month prior to study entry, or expected use of experimental or licensed vaccines or blood/blood products during the duration of the study.
* Receipt of immunoglobulin or other blood product within 3 months prior to enrollment
* Receipt of other licensed vaccines within the preceding 4 weeks
* History of a severe reaction following influenza vaccination
* Use of cytotoxic therapy or biologic modifiers in the previous 2 years.
* Plans to receive cytotoxic therapy during the study period.
* Concurrent acute moderate to severe illness. (Vaccination will be deferred until recovery. Subjects with mild illnesses with fever ≤37.8ºC orally may be enrolled).
* History of medical disorder associated with immunosuppression (eg. including HIV-infected individuals, transplant recipients)
* History of chronic lung, cardiac, renal or liver disease, which has required hospitalization in the last year.
* Receipt of any high-dose daily systemic corticosteroids (inhaled steroids are acceptable) within two weeks of study entry. High dose is defined as a dose of 20 mg of prednisone daily or its equivalent. Topical steroids are allowed.
* Failure to give written, informed consent
* History of febrile illness (\>37.8ºC orally) within the past 72 hours (immunization may be deferred).
* Known allergy to eggs or other components of vaccine (i.e., thimerosal)
* History of Guillain-Barré Syndrome (GBS)
Efficacy Study of Acupuncture to Relieve Symptoms of Chronic Prostatitis

Limited evidence suggests that acupuncture may help relieve symptoms of chronic prostatitis/chronic pelvic pain syndrome. This study evaluated if acupuncture twice weekly for 10 weeks would help ameliorate symptoms of CP/CPPS.

Various studies have reported that this acupuncture able to relieve symptoms of chronic prostatitis (CP)/ chronic pelvic pain syndrome (CPPS). However, controversy exists on the efficacy of this technique due to poor experimental designs and lack of placebo controls in these experiment. This study is the first randomised controlled study which will evaluate if acupuncture for 10 weeks will help improve symptoms of CP/CPPS

Eligibility Criteria:
Inclusion Criteria:

* Symptoms of discomfort or pain in the pelvic region for at least a three (3) months period within the last six (6) months.
* Moderate overall score on the NIH-CPSI (overall score more than 15 out of a potential of 0-43 points)
* Diagnosed as having CPPS Category III
* Participant is willing to undergo 10 weeks of acupuncture treatment

Exclusion Criteria:

* History of prostate, bladder or urethral cancer.
* Inflammatory bowel disease (such as Crohn's disease or ulcerative colitis, but not irritable bowel syndrome).
* Undergone pelvic radiation or systemic chemotherapy, intravesical chemotherapy or intravesical BCG.
* Treated for unilateral orchialgia without pelvic symptoms.
* Active urethral stricture.
* Undergone TURP, TUIP, TUIBN, TUMT, TUNA, balloon dilation of the prostate, open prostatectomy or any other prostate surgery or treatment such as cryotherapy or thermal therapy.
* Neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.
* Liver disease.
* Diagnosed as acute or chronic bacterial prostatitis.
* History of urinary tract infection positive uropathogen for the past year.
* Taking medications which could affect the lower urinary tract function
* History of type 1 or 2 diabetes.
* Treated/currently undergoing treatment with acupuncture for any other illness including prostatitis for the past 6 months.
* Refusal to be needled or any form of bleeding disorder.
Prevention Trial Assessing Paper-Tape in Endurance Distances II (Pre-TAPED II)

Friction foot blisters are one of the most common and often debilitating complaints of all athletes, and hikers and runners in particular. Blistering rates in the literature of outdoor hikers range from 7%-54%. This study's aim is to build on Pre-TAPED I, and determine whether applying paper tape to the areas of the foot where blisters historically occur in endurance runners can prevent the incidence of friction blisters.

Participants will be ultra-endurance athletes competing in Racing the Planet's 250 mile/7 day 4 Desert events in 2014 (Jordan, Gobi, Madagascar, and Atacama. A convenience sample will be used, with full consent signed before inclusion into the study, with participants being informed that study inclusion is entirely optional and will not affect medical care. Randomization will be conducted for each participant, a coin will be flipped to determine which foot is to be taped, heads - right foot, and tails, left foot. The non-taped foot will be used as a control. The runner's normal sock/shoe system will be used to reflect natural wilderness conditions. Participants will have demographic data collected prior to the race, including age, gender, country of origin, number of marathons run prior, pack weight, and sock type. The study endpoint occurs when a hot spot or blister develops on either the treated or untreated foot. Runners will be instructed to treat suspected blisters or hot spots as they normally would, and to inform the study administrators the same day for visual inspection and final questionnaire to determine if they develop blisters or hot spots, whether they applied or re-applied tape themselves, removed tape, and the reasons for these actions.

Participants will have tape applied to area(s) prone to blister on 1 foot, if no blister history, 1 area will be randomly assigned. The tape will be left on the selected foot until a blister or hot spot develops on either foot or the end of the race, whichever comes first. At that point, the study is over and the participant can continue or stop taping at their choice. If participants are prone to blisters or hot spots in particular areas, 1" paper tape applied to that site on trial foot. However, if the participant has no previous blister or hot spot experience, a site will be randomly assigned by picking a piece of paper out of a bag with the site written on a piece of paper (heel, toe, instep, head of 5th metatarsal). Therefore, a single participant can have more than 1 site on an individual foot.

Eligibility Criteria:
Inclusion Criteria:

Any runner who are enrolled in an RTP 4 deserts event, All runners who are 18-75 years old All runners who speak or read English. The study will be enrolling only those who speak or read English, so they can fully understand and have knowledgeable consent to the study enrollment protocols.

Exclusion Criteria:

Any blisters, broken blisters, or hot spots present on either foot at the time of initial taping as determined by visual foot inspection by a enrolling researcher.

The runner allergic to paper-tape.
XIENCE V® EXCEED: Evaluation of XIENCE V® Catheterization Lab Endpoints and Excellence in Delivery

This trial is to assess physician-determined XIENCE V® EECSS acute performance, deliverability and resource utilization in the catheterization lab during commercial use by various physicians with a range of coronary stenting experience

This study will evaluate overall physician-determined XIENCE V® Everolimus Eluting Coronary Stent system (XIENCE V®) acute performance, deliverability and resource utilization in the catheterization lab in the "real world" as used by a broad group of physicians at a variety of health care facilities. This study will include all consecutively enrolled patients in the United States of America (USA) who consent to participate and receive XIENCE V® stents.

Eligibility Criteria:
General Inclusion Criteria:

* The patient agrees to participate in this study by signing the IRB approved informed consent form prior to the index procedure.
* Alternatively, the patient's legally authorized representative agrees to the patient's participation in this study and signs the informed consent form prior to the index procedure.

General Exclusion Criteria:

* Inability to obtain an informed consent is an exclusion criterion.
Rehabilitation of Patients With Modic Changes in the Lumbar Spine

The purpose of this study is to compare patients with low back pain (LBP) and Modic Changes from The Backcenter Funen, Ringe:

1. To compare the effect of two types of non-operative treatments:

   A. exercise and advice to be physically active

   B. restitution and advice not to overload the spine
2. To investigate if the results of the treatment are influenced by gender, age, smoking, and physical load.

The clinical experience is that many patients with Modic changes have relatively severe and persistent LBP, which typically appears to be resistant to treatment. Furthermore, a retrospective study at The Backcenter Funen, Ringe, shows that patients with MC fail to improve engaging physical activity. This is unfortunate, because the typical rehabilitation for patients with persistent LBP is back exercises and information about keeping physically active. This means that this relatively large subgroup of patients with Modic changes probably does not improve with the rehabilitation tools used today.

A randomised controlled trial has therefore been designed to study the specific subgroup of patients with Modic changes. In this study we will compare the present "state-of-the art" rehabilitation approach to persistent LBP (namely to exercise and keep active) with a new concept (restitution). The justification for this is that restitution reduces mechanical stress on the vertebrae and therefore would allow heeling of the possible micro fractures in Modic changes.

Eligibility Criteria:
Inclusion Criteria:

Primary inclusion criteria for receiving MRI

* The patient must have LBP with a current duration of 3 - 12 month.
* The patient must have an actual pain intensity ≥4 on numerical pain rating scale from 0-10.

Secondary inclusion criteria for receiving MRI

* The patient must speak and understand Danish.
* The patient must be between 18-60 years of age.
* The patient must be willing to participate in the project. Inclusions criterium for the project
* There must be an MRI showing MC in the lumbar spine.

Exclusion Criteria:

* The patient is unable to go through with the project because of other physical or mental disorder.
* The patient is pregnant.
* The patient is referred to operation.
Inspiratory Muscle Training in Patients With Stroke in Subacute Phase.

Assess the effect of inspiratory muscle training on lung function, muscle strength and trunk balance in survivors of stroke in the subacute phase of the disease

Assess the effect of inspiratory muscle training on lung function, muscle strength and trunk balance in survivors of stroke in the subacute phase of the disease. The intervention will be done in a group of patients who will be treated in the rehabilitation service at the Virgen de la Arrixaca Hospital. They will train using a threshold IMT device or a Powerbreathe device, to increase their inspiratory muscle strength in addition to a physical therapy treatment. The intervention will last eigtht weeks and the patients will be evaluated at the beginning and at the end of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Sroke 6 months before of the beginning of the study
* Be able to understand simple commands
* Hemiparesis or hemiplegia
* Not have serious cardiopulmonary diseases(COPD,asthma,bronchiectasis)

Exclusion Criteria:

* Associated neurological pathology leading to muscle weakness
* Severe respiratory pathology, pulmonary embolism, presence of tracheostomy cannula,
* intracranial hypertension
* Acute retinal datachment, recent eye surgery
* Impossibility of labial occlusion
* Unstable heart disease, unstable angina, aortic aneurysm
* Recent thoracic or abdominal surgery(6 months)
* Uncontrolled arterial hypertension
BPK-S Integration (Ceramic) Post Market Clinical Follow-Up

Post-market prospective clinical study with a medical device. Data from patients that routinely receive a primary BPK-S-integration knee implant made of ceramic will be documented with a follow-up time of 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Congenital or acquired knee joint defects/deformation which necessitate the implantation of a knee joint replacement
* Defects or malfunctions of the knee joint
* Degenerative, rheumatic, post-traumatic arthritis/arthrosis
* Symptomatic knee instability
* Reconstruction of flexibility
* Patients with material hypersensitivity

Exclusion Criteria:

* Obesity or overweight of the patient
* Acute or chronic infections near the implantation
* Diseases that impair bone growth such as cancer, renal dialysis, osteopenia, etc.
* Sensitivity to foreign matter in the implant materials
* Bone tumors in the area of the implant anchoring
* Illnesses which can be treated without using a knee implant
* Lack of patient cooperation
* Abuse of medication, drug abuse, alcoholism or mental disease
* Pregnancy
* Serious osteoporosis
* Serious damage to the bone and soft tissue structures which impedes stable anchoring and joint function
* Systemic diseases and metabolic disorders
* Overload of the knee implant to be expected
Documentary to Encourage Plant-based Eating

This study will assess whether watching a documentary video about the health, environmental, and ethical consequences of eating meat and animal products reduces participants' self-reported intake of these items.

See detailed preregistration: https://osf.io/xrckh/registrations

Eligibility Criteria:
Inclusion Criteria:

* Participant is currently located in the United States
* Participant is at least 18 years old

Exclusion Criteria:

* Participant is located outside the United States
* Participant is less than 18 years old
Effect of Adding Dexamethasone to Intrathecal Bupivacaine on Blood Sugar of Patients Undergoing Diabetic Foot Surgeries

effect of intrathecal dexamethasone on blood sugar of dietetic patients


Eligibility Criteria:
Inclusion Criteria:

* control diabetic patients will undergo foot surgeries.

Exclusion Criteria:

* The exclusion criteria included patient refusal, patients with major cardiac, respiratory, renal, hepatic disorders or uncontrolled diabetes mellitus, history of chronic use of analgesic medication or hypersensitivity to drugs under investigation, any contraindication to regional anesthesia, namely; patients with coagulopathy infection at puncture site, backache, spine deformity or prior surgery, neuromuscular disorders or psychic disturbances
The Safety and Pharmacokinetic/Pharmacodynamic Study of CKD-841 in Postmenopausal Female, Phase 1

A randomized, single-blinded, parallel design phase I clinical trial to investigate the safety and pharmacokinetics/pharmacodynamics of CKD-841 A-1, CKD-841 D or Leuplin Inj. after subcutaneous injection in postmenopausal female

To investigate the safety and pharmacokinetics/pharmacodynamics of CKD-841 A-1, CKD-841 D or Leuplin Inj. 3.75 mg after subcutaneous injection in postmenopausal female

Eligibility Criteria:
Inclusion Criteria:

* Healthy menopausal female
* β-hCG is negative at screening and before administration of investigational drug
* Infertility by sterilization operation before 5 months from screening excluding ovarian cancer, uterine cancer etc.
* Bwt ≥ 50Kg and Body Mass Index (BMI) ≥ 18.5 and \< 28.0

Exclusion Criteria:

* History or current condition of disease related to Hepato-biliary system, renal system, nervous system, mental illness, immune system, respiratory system, endocrine system, hemato-oncology, circulatory system, musculoskeletal system or except for that, significant clinical disease
* Uncontrolled diabetes mellitus in the last three months
* Pregnancy or breast feeding
* History of taking medicine such as Leuprorelin acetate or similar affiliation drug within 12 weeks before administration of investigational drug
* Has hypersensitivity to the active ingredient or excipients or same affiliation drug of the investigational drug, hypersensitivity of a medicine contained gelatin especially