cyrilzakka/clinical-trials huggingface dataset:
Post-Marketing Surveillance of Humira in Korean Pediatric Crohn's Disease (CD) Patients Under the "New-Drug Re-examination"

This study is a non-interventional, observational study of Humira® in the treatment of pediatric CD as per the New Drug Re-examination Guideline in Korea. This study will be conducted in institutions which provide a written agreement to AbbVie Korea, and where the use of Humira® for pediatric CD is following their normal medical practice setting. Pediatric patients who are prescribed Humira® as per physician's medical judgment in accordance with the approved Korean local label will be enrolled in the study. As this is a post marketing surveillance, AbbVie is NOT involved in the product supply since the drug is being used according to the approved marketing label and is to be prescribed by the physician under usual and customary practice of physician prescription.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients with CD who are prescribed Humira in accordance with the Korean label for Humira authorization (labeling)
* Patients who have given written authorization to use their personal health data for the purposes of this study.

Exclusion Criteria:

* Any contraindications to Humira as listed on the approved product market authorization (labeling)
* Patients who is participating on other clinical trials.
Clinical Evaluation of the Efficacy of a Medical Device in Treatment of Toenail Onychomycosis

This study evaluates the effect of the medical device "Excilor® Fungal Nail Infection" in the treatment of toenail onychomycosis. Half of the participants will receive the tested product and the other half will receive a comparator (Amorolfin 5%). Patients will be followed during 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Subject having given her/his informed, written consent,
* Subject cooperative and aware of the modalities of use and the necessity and duration of the controls so that perfect adhesion to the protocol can be expected.
* Subject being psychologically able to understand information and to give their/his/her consent.
* Age: more than 18 years.
* Subject with superficial onychomycosis on at least one great toenail or light to moderate disto-lateral onychomycosis (without matrix involvement and involvement \<2/3 of the tablet).
* Subject with positive results of KOH staining.
* Subject having stopped any systemic antifungal treatment since at least 6 months before inclusion and/or any topical antifungal treatment since at least 3 months before inclusion.
* Female subjects of childbearing potential should use an accepted contraceptive regimen since at least 12 weeks before the beginning of the study, during all the study and at least 1 month after the study end.

Exclusion Criteria:

* Subject considered by the Investigator likely to be non-compliant with the protocol.
* Patient enrolled in another clinical trial during the test period.
* Woman being pregnant, nursing or planning a pregnancy during the course of this study.
* Subject having a known allergy to one of the constituents of the tested products.
* Patient suffering from serious or progressive diseases (to investigator's discretion), such as diabetes, peripheral circulatory disease, HIV, psoriasis, lichen planus, immunosuppressive pathology....
* Subject with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis...).
Therapeutic Effect of Immunoadsorption for Patients With Lipoprotein Glomerulopathy

The purpose of this study is to assess the efficacy and safety of immunoadsorption in the treatment of lipoprotein glomerulopathy.

Lipoprotein glomerulopathy is characterized by nephritic syndrome glomerular protein thrombi and lipid abnormalities, particularly with an elevated level of plasma apoprotein E (apoE).There are no efficiency way to treat lipoprotein glomerulopathy. We firstly successfully treat 2 patients by protein A immunoadsorption with remarkable decreased urine protein and reduction of lipoprotein thrombi on repeated renal biopsy.

Eligibility Criteria:
Inclusion Criteria:

1. A new diagnosis of lipoprotein glomerulopathy proved by histology and serology
2. Age 15\~60 years, sex free

Exclusion Criteria:

1. Serum creatinine \> 500 umol/l
2. Severe viral infection(HBV, HCV, CMV) within 3 months of first randomization or known HIV infection
3. Congenital or acquired immunodeficiency
4. Patients with severe infection or central nervous system symptoms
5. Immediately life-threatening organ manifestations (e.g. lung haemorrhage or massive gastro-intestinal bleeding, heart failure due to pericarditis or myocarditis, liver dysfunction measured on at least 2 separate occasion)
The Effect of Powered-Knee Exoskeleton Assist on Stair Climbing in Acute CVA

Hypothesis/Specific Aims: The purpose of this research study is to determine if using an exoskeleton during stair climbing training will result in an improved ability to walk and climb stairs in individuals affected by recent stroke as compared to stair climbing training without an exoskeleton.

Participants will be randomized into one of two groups. Group 1 will wear the exoskeleton device while completing all training sessions. Group 2 will not wear the exoskeleton device during training sessions. All screening and evaluation sessions will be completed without the exoskeleton device for both Group 1 and Group 2. Pre and post-session vitals (blood pressure, heart rate) will be taken and monitored throughout the session as needed. Gait belts and/or overhead track and harnessing systems will be used throughout sessions as needed for increased safety of participants. Skin integrity will also be monitored both before and after each use of the exoskeleton device.

Each enrolled participant will complete the following sessions:

Session 1: Screening

* After consenting, subjects will undergo a physical evaluation and screening exam by a licensed physical therapist. If they meet study criteria, they will be randomly placed into either the Keeogo group or the traditional stair training group using a random number generator and they will be entered into the study. Once they are enrolled, baseline outcome measures will be assessed.

Sessions 2 through 6: Training

* Subjects will participate in 30 minutes of stair training with or without the exoskeleton device, depending on group assignment.

Session 7: Post-Testing

* Outcomes measures will once again be assessed by a licensed physical therapist.

Eligibility Criteria:
Inclusion Criteria:

* Patient in the inpatient rehabilitation setting
* less that 3 months post-hemorrhagic or ischemic cerebrovascular accident (CVA)
* No previous diagnosis or treatment for CVA
* Acute inpatient rehabilitation discharge goal of stair negotiation
* 18 years of age or older
* Waist and leg circumference and lower extremity lengths appropriate for a comfortable and safe fit in the Keeogo study device
* Medical clearance from a Shirley Ryan AbilityLab (SRALAB) inpatient physician

Exclusion Criteria:

* Unwilling to participate
* Unable to provide autonomous consent due to cognitive or communication impairment
* Legally blind
* Pregnant or lactating
* Skin condition that contraindicates use of orthotics or support braces
* History of multiple CVA
* History of any additional neuropathology diagnosis, such as Parkinson's disease, multiple sclerosis, traumatic brain injury, or spinal cord injury
A Study of TAK-441 in Adult Patients With Advanced Nonhematologic Malignancies

This is the first study in which TAK-441 is administered to humans. The patient population will consist of adults aged 18 or older who have advanced nonhematologic malignancies and for whom standard treatment is no longer effective or does not offer curative or life-prolonging potential. Following completion of the dose escalation study, patients will be enrolled as part of 2 expansion cohorts.


Eligibility Criteria:
Inclusion Criteria:

Each patient must meet all of the following inclusion criteria to be enrolled in the study:

* Male or female 18 years or older
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
* Diagnosis of a nonhematologic malignancy for which standard treatment is no longer effective or does not offer curative or life-prolonging potential
* Meet other clinical, radiographic or laboratory inclusion criteria as specified in the protocol
* Voluntary written consent

Exclusion Criteria:

Patients meeting any of the following exclusion criteria are not to be enrolled in the study:

* Life-threatening illness unrelated to cancer
* Receiving other treatment (radiotherapy, antineoplastics or investigational agents) within protocol specified windows of first dose of TAK-441
* Patients with brain metastases who do not meet criteria specified in study protocol
* Known history of human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C
* Major surgery within 14 days before the first dose of TAK-441
* Infection requiring systemic therapy, or other serious infection within 14 days of the first dose of TAK-441
* Do not meet other clinical, laboratory or radiographic criteria as specified in the protocol
Partnered Multicomponent Exercise for Elderly in Long-term Care Facilities

This study aimed to explore the effects of a partnered multicomponent exercise program on improving the physical function and sense of well-being of elderly people in Long-term Care Facilities (LTCFs).

This study is a single-blinded randomized controlled trial. Elderly residents were recruited from two LTCFs in Yilan county. The experimental group (N=14) received a 90-minute partnered multicomponent exercises intervention once weekly for 12 weeks. The control group (N=14) carried out the usual activities without intervention. The Barthel Index (BI), Short Physical Performance Battery (SPPB), De Morton Mobility Index(DEMMI), handgrip strength, and Chinese Happiness Inventory (CHI) were measured before and after the interventions.

Eligibility Criteria:
Inclusion Criteria:

* Over 60years old,living in the long term care facilities,after Physician agrees.No infectious diseases.

Exclusion Criteria:

1. Acute disease or unstable state (such as heart failure).
2. Severe musculoskeletal diseases (such as fractures, lower limb joint pain and deformation).
3. Cognitive impairment (MMSE\<20) .
4. At the end of life.
Lipid-lowering Effect of a Plant Stanol Ester Supplement Product

Purpose of the study is to determine the effect of the investigational products as consumed with a meal on serum lipids, primarily on LDL cholesterol.


Eligibility Criteria:
Inclusion Criteria:

* male and female over 18 years old
* serum LDL cholesterol \> 3.0 mmol/L
* BMI \< 35
* subjects must voluntarily sign the informed consent

Exclusion Criteria:

* subjects using lipid lowering medication (ezetimibe, bile acid sequestrant, statin therapy)
* subjects with any hepatic or renal disorder according to medical history
* subjects who have history of myocardial infarction or unstable angina pectoris within six months prior to screening
* subjects who have history of coronary artery bypass graft or percutaneous transluminal coronary angioplasty within six months prior to screening
* subjects who have history of temporal ischemic attack or stroke within six months prior to screening
* subjects who have a history of cancer or other malignant disease within the past five years
* subjects who are consuming more than 15 portions of alcohol / week
* subjects who are pregnant or lactating
* subjects using cholesterol-lowering foods or dietary supplements within 14 days before start of the intervention
* subjects with intolerance to any ingredient of the test product
Vitamin D Supplementation in Physical Performance

This study was performed to evaluate the efficacy of weekly vitamin D supplementation on athletic performance in Iranian athletes

Seventy subjects were enrolled in the study. The athletes were randomly divided into two groups: vitamin D supplement (D; received 50,000 IU of vitamin D supplement weekly) and control (P, received a placebo weekly). Duration of the study was eight weeks. Anthropometric, dietary, athletic performance and biochemical evaluations were performed for all subjects in the beginning and in the end of the intervention period.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* professional athletes

Exclusion Criteria:

* receiving vitamin D supplement in past 3 months
An Evaluation of a New Technique Utilizing a Biologic Glue and Tissue Patch to Seal the Cut Edge of the Pancreas Following Removal of the Tail of the Pancreas

The purpose of this trial is to determine whether the use of an autologous falciform ligament patch combined with fibrin glue will reduce the rate of pancreatic fistula in patients completing distal pancreatectomy. The hypothesis for the current trial is: Autologous falciform patch closure with fibrin glue will result in a 50% decrease in fistula formation postoperatively. The primary end point will be the development of pancreatic fistula using the ISGPF definition of pancreatic fistula1. (Drain output of any measurable volume of fluid on or after postop day #3 with an amylase content greater than three times serum amylase). Secondary end points will include length of postoperative hospital stay, percutaneous intervention rates, re-operation rates, morbidity to include delayed gastric emptying, wound infection, intraabdominal abscess, postoperative hemorrhage and 30-day mortality.(Bassi C, Dervenis C, Butturini G, et al. Postoperative pancreatic fistula: An international study group (ISGPF) definition. The Journal of Surgery, 2005;138:8-13).


Eligibility Criteria:
Inclusion Criteria:

1. completion of a successful distal pancreatectomy with/without splenectomy
2. patient must have a pancreatic remnant in place
3. there must be a viable falciform ligament for creation of the autologous patch

Exclusion Criteria:

1. patients undergoing total pancreatectomy
2. patients undergoing distal pancreatectomy who have previously completed a right sided resection of the pancreatic head, uncinate and neck
3. failure to sign informed consent
4. pregnant patients
5. patients in whom previous surgery has eliminated the falciform ligament, i.e. previous liver resection
A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) as Maintenance Treatment in Patients With Metastatic Colorectal Cancer

This 2 arm study assessed the efficacy and safety of maintenance treatment with Avastin (bevacizumab) + Xeloda (capecitabine), after initial treatment with Xeloda + oxaliplatin + Avastin, in patients with metastatic colorectal cancer. Patients were randomized into one of 2 groups to receive 1) Xeloda + oxaliplatin + Avastin until disease progression or 2) Xeloda + oxaliplatin + Avastin for 6 3-week cycles, followed by Xeloda + Avastin until disease progression. Xeloda was administered at a dose of 1000 mg/m\^2 orally twice a day on days 1-14 of each cycle, oxaliplatin at a dose of 130 mg/m\^2 intravenously (iv) on day 1 of each cycle, and Avastin at a dose of 7.5 mg/kg iv on day 1 of each cycle.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, ≥ 18 years of age.
* Histologically confirmed colon or rectal cancer, with unresectable metastatic disease.
* At least 1 measurable lesion.
* Outpatient, with Eastern Cooperative Oncology Group (ECOG) Performance Status = 0-1.

Exclusion Criteria:

* Previous treatment with Avastin.
* Previous systemic treatment for advanced or metastatic disease.
* clinically significant cardiovascular disease.
* Daily chronic treatment with high doses of aspirin (\> 325 mg/day) or non-steroidal anti-inflammatory drugs.
Use of Physiology to Evaluate Procedural Result After PCI CTO

ULTRA-CTO is a prospective multicentre non-randomised investigator-initiated trial designed to enrol 200 subjects with an indication for percutaneous coronary intervention (PCI) of chronic total occluded (CTO) coronary artery.

The main objective of the study is to assess the predictive value of post-PCI resting full-cycle ratio (RFR) and fractional flow reserve (FFR) with regard to Fractional flow reserve (SSR) in CTO patients.

ULTRA-CTO is a prospective multicentre non-randomised investigator-initiated trial designed to enrol 200 subjects with an indication for PCI CTO.

The main objective of the study is to evaluate both the value of post-PCI RFR and post-PCI FFR for detecting suboptimal stent result (SSR).

After angiographically successful CTO PCI, intra-coronary physiologic assessment (RFR, FFR, coronary flow reserve (CFR) and index of microcirculatory resistance (IMR)) of the CTO vessel will be performed. Additional OCT will be performed directly or during a staged procedure within 4 ± 2 weeks when indicated (i.e. high contrast use, procedural duration, major dissection or other safety reasons according to the operator).

When intra-coronary physiologic assessment or OCT is not possible at all, the patients will not be included in the study.

When the operator decides to optimize the stent result (post-dilation or additional stenting), based on the OCT and/or physiology, post-PCI RFR and FFR should be repeated. For patients undergoing a clinically indicated FFR of a remaining intermediate stenosis (angiographically 30-90%) in a non-CTO vessel or major side branch of the CTO vessel within 4 weeks after the index procedure, intra-coronary physiologic assessment (RFR, FFR, CFR and IMR) will be repeated in the CTO vessel for exploratory objectives

At 4 ± 2 weeks follow-up, the occurrence of cardiovascular events and clinical classification will be assessed for secondary objectives

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years and older.
2. Angiographically successful PCI CTO without any remaining lesion at least 30% proximal to the stented segment.
3. Possibility to perform physiologic measurements and OCT of sufficient quality.
4. Patients willing and capable to provide written informed consent.

Exclusion Criteria:

1) Contra-indication for adenosine.
Efficacy of Two Internet Delivered Intervention Programs for Depression: Behavioral Activation vs Physical Activity

To compare the clinical and cost-effectiveness of Behavioral Activation (BA) and Physical Activity (PA) for adults with major depressive disorder (MDD) or adjustment disorder with depressive symptomatology with a wait list control group (WL) in Spanish population.

Research shows that in 2030 (Mathers and Loncar, 2006) depression will become one of the three leading causes of disability. Depression is a common mental disorder with a negative impact on mental well-being, quality of life, and social and work-related functioning both in the short and longer term.

Additionally, depression is associated with increased morbidity, mortality, health care utilization and health care costs. On a population level, depression is one of the most costly diseases. The economic costs of depression were estimated at €136.3 billion (EU25) in 2010 in the EU and are still rising. European health care systems face the challenge of improving access to cost-effective treatments while simultaneously working to sustain budgetary stability in times of economic austerity.

Internet-based depression treatment appears a very promising alternative to current routine depression treatment strategies. Meta-analyses have demonstrated the clinical effectiveness and potential cost-effectiveness of Internet-based treatment for depression in controlled research setting. Internet-based treatment thus has the potential to keep depression treatment affordable, as it enables mental health care providers to reach out to large populations needing depression treatment at a better cost-effectiveness, but with similar levels of clinical efficacy and quality of care.

In Spain the trial will be carried out in a community sample, comparing the clinical and cost-effectiveness of BA or PA with WL for adults with major depressive disorder (MDD) and adjustment disorder with depressive symptomatology. Respondents will be followed until 6 months after baseline (measures will be taken at BL, 3 months, and 6 months).

Eligibility Criteria:
Inclusion Criteria:

* Being 18 years of age or older
* Meet DSM-IV diagnostic criteria for MDD and adjustment disorder confirmed by MINI International Neuropsychiatric Interview version 5.0 and SCID I
* A score of 5 or higher on the PHQ-9 screening questionnaire.

Exclusion Criteria:

* Current high risk for suicide according to the MINI Interview section C
* Serious psychiatric co-morbidity: substance dependence, bipolar affective disorder, psychotic illness, obsessive compulsive disorder, as established at the MINI interview
* Currently receiving psychological treatment for depression in primary or specialised mental health care
* Being unable to comprehend the spoken and written language (Spanish)
* Not having access to a PC and fast Internet connection (i.e. broadband or comparable).
Effects of Calcium and Phytate on Zinc Absorption

This study is determine the effects of dietary calcium and phytate on zinc absorption.

Zinc absorption is tested from 2 days of consuming each of four diets with zinc-65 isotope, followed by retention monitoring in a whole body scintillation counter for 4 weeks. All four 4 experimental diets are tested with each subject, in randomized order, for a total of 16 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Average weight for height

Exclusion Criteria:

* Medications other than birth control pills or hormone replacement therapy,
* Pregnancy within last 6 months
A New Diet for Patients With Autosomal Dominant Polycystic Disease (ADPKD)

Recent evidence has shown that kidney volume predicts the likelihood of developing renal insufficiency over a finite length of time in ADPKD, suggesting a linkage between the growth of cysts and the harm they do to kidney function. Recent studies indicate that the rate of kidney volume increase is hastened by excess dietary protein, salt, and potential net acid precursors, and slowed by increased water intake sufficient to lower plasma vasopressin levels.

Diets are commonly prescribed to treat ADPKD and other renal patients with disease near the end-stage, but there is currently no specific diet prescription that takes potentially harmful dietary elements into account for ADPKD patients in the earliest stages of the disease. This study will examine a novel diet for ADPKD created by the researcher termed the ADPKD diet.


Eligibility Criteria:
Inclusion Criteria:

* Have not been prescribed dietary restrictions or enhancements
* Blood pressure \<135/85 mmHg with or without specific treatment
* Willingness to participate for at least one month
* Diet history consistent with the excretion of \>30 mEq NAE / day based on usual dietary intake

Exclusion Criteria:

* Other active diseases requiring pharmacologic agents
* Unstable weight (+/- 2 kg) for 3 months prior to enrollment
* Food allergies
* Pregnancy or lactating
* Confounding medications, i.e. bicarbonate, citrate
* Individuals who do not consume meat for personal, religious, or health reasons.