cyrilzakka/clinical-trials huggingface dataset:
STA-5326 in Crohn's Disease Patients

The purpose of this study is to determine the safety and tolerability of STA-5326 given once daily or twice daily to Crohn's Disease patients with moderate disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18-65 years old
* Crohn's Disease for 6 months
* CDAI scores between 220-450
* +/- 5-ASA, stable dose for \> 2 weeks
* +/- Corticosteroids, less than or equal to 40 mg per day with a stable dose for 2 weeks
* +/- Infliximab with no treatment within 4 weeks
* +/- 6-Mercaptopurine, with a stable dose for 8 weeks
* +/- Antibiotics, with a stable dose for 2 weeks

Exclusion Criteria:

* Patients who have had methotrexate, cyclosporine, or other experimental drug within 3 months of screening
* Pregnancy, breast feeding
* History of total proctocolectomy with stoma. Previous ileocolectomy would not be a contraindication to the study
* Bowel obstruction
* Surgical bowel resection within 90 days
* Total parenteral nutrition (TPN), CYA, tacrolimus
Epiceram™ Device Versus Mid-Strength Topical Steroid (Fluticasone Propionate 0.05%) for Treatment of Atopic Dermatitis

Novel therapies for AD that avoid immunosuppression and potential carcinogensis are needed. EpiCeram™ , a topical cream, represents a novel class of therapy for skin disorders that does not contain corticosteroids or other anti-inflammatory drugs. The objective of the present study is to demonstrate the safety and efficacy of EpiCeram ™ in the treatment of moderate to severe atopic dermatitis as compared to mid-strength topical steroid cream following twice daily dosing for four weeks in pediatric patients with AD. The potential benefit to patients lies in the potential for EpiCeram ™ to provide restoration of the normal skin barrier as shown in previous studies and eliminate or reduce the requirement for supplemental topical steroid administration.


Eligibility Criteria:
Inclusion Criteria:

* Subjects willing to provide written informed consent (i.e. assent with parental/guardian consent for ages \> 7 to 18 years and parental consent for ages 6 months to 7 years) to participate in the study
* Males or Females
* Age: 6 months to 18 years
* Diagnosis of Moderate to Severe Atopic Dermatitis (AD) on the basis of criteria defined by the Rajka-Langland Severity Index

Exclusion Criteria:

* Subjects with mild AD as defined by the Rajka-Laneland Severity Index.
* Subjects having greater than 20% BSA as measured by SCORAD "Extent" (A) score (total amount of body surface area requiring application of either Cutivate® or EpiCeram® exceeds 20%)
* Subjects with unstable or uncontrolled medical conditions that could require intensive treatment during the course of the study.
* Subjects who require greater than 2mg per day of inhaled or intranasal steroids.
* Subjects who are currently participating in, or have participated in another investigational drug/device trial within the past month.
* Subjects with known allergy to or hypersensitivity to EpiCeram™ or Fluticasone or Cetaphil.
* Active infection of any type at the start of the study.
Exploring the Knowledge, Attitudes, Behaviors and Perceived Barriers of Hepatologists Towards Non-invasive Hepatocellular Carcinoma Prediction Models in Hepatitis C Patients Who Achieved Sustained Virological Response Following Direct Acting Antivirals Therapy

This study aims to assess the knowledge, attitudes, and behaviors (KAB) of hepatologists regarding different models used to predict hepatocellular carcinoma (HCC) in patients with chronic hepatitis C (HCV) who achieved sustained virological response (SVR) after direct-acting antiviral (DAA) therapy. The study will use a structured questionnaire targeting hepatologists globally to evaluate their familiarity with, confidence in, and clinical application of various predictive models. The primary outcome is the proportion of hepatologists who incorporate prediction models in clinical practice, while secondary outcomes include the level of knowledge about different models, perceived reliability, and barriers to their implementation the aim of the study 1) To evaluate the level of knowledge among hepatologists regarding existing HCC prediction models for post-SVR HCV patients.

2) To assess hepatologists' attitudes toward the utility, reliability, and clinical value of these models.

3) To identify the extent to which hepatologists incorporate predictive models into their clinical decision-making.

4) To determine perceived barriers to the adoption of these models in clinical practice.

5) To explore the factors associated with poor adoption of these predictive models.


Eligibility Criteria:
Inclusion Criteria:

* Hepatologists with at least one year of experience in managing HCV patients

Exclusion Criteria:

* Non-hepatologists, general practitioners, or respondents who submit incomplete surveys
Long-term Fasting: Multi-system Adaptations in Humans

The aim of this trial is to investigate the effects of long-term fasting on size, mass, composition and function of metabolic active tissues in several organs that reexpand possibly rejuvenated after 1-4 months. Additionally, the lipid metabolism is investigated in depth.

Fasting displays numerous positive effects on metabolism, health and aging. Surprisingly, few considerations are given to long-term fasting periods.

The metabolic switch from food-derived glucose to adipose tissue-derived fatty acids and ketones as primary cellular fuel is the key to fasting metabolism. Fasting has been shown to improve cardiovascular risk factors and gut microbiota in humans. It provokes profound changes in lipid metabolism. However, many questions are still open concerning the mobilization, exchange, and function of lipids during long-term fasting. Furthermore, recent results show the ability of periodic restrictive nutritional strategies to trigger organ regeneration. This promising regenerative power has not been investigated comprehensively in humans. In addition, the knowledge about the role of human faecal microbiota in health and disease is increasing. Only little is known about its composition and function during fasting. We found indications that the gut microbiome could influence energy metabolism and consequently could influence the dynamic of the metabolic switch.

Long-term fasting under medical supervision according to the Buchinger Wilhelmi fasting program has been demonstrated to be safe and well-tolerated.

The current project investigates the effects of a 9±3 days fasting period by a multi-systemic approach focusing on lipid metabolism and the gut microbiome in 100 subjects. Additionally, the body composition in combination with muscle performance will be analyzed in-depth in a subgroup of 32 subjects.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 22 - 35 kg/m2

Exclusion Criteria:

* intake of medication (cardiovascular diseases, lipid and glucose metabolism)
* chronic manifest psychical and psychiatric diseases
* participation in another study
* pregnancy or breastfeeding
* in the MRI/MRS sub-study, any MRI contraindication (claustrophobia, pacemakers, MR-incompatible prosthetic valves, metallic implants, foreign metallic body)
* active uncontrolled gastrointestinal disorders including ulcerative colitis, Crohn's disease, indeterminate colitis, severe irritable bowel syndrome, persistent infectious gastroenteritis, persistent or chronic diarrhea of unknown etiology, recurrent Clostridium difficile infection
* major surgery of the GI tract, in the past five years. Any major bowel resection at any time
* intake of antibiotics in the last 2 months
Sweat Duct Imaging in Mother/Newborn Dyads

The purpose of this study is to evaluate sweat duct number on the plantar surface of newborn infants using a non-invasive confocal microscopy device.

In this exploratory study, the investigators propose to evaluate sweat duct number on the plantar surface of newborn infants using a non-invasive confocal microscopy device (Lucid Vivascope®). This approach has the potential to be valuable in repeated sweat endpoint assessments, as the device was selected based on its ease of use, the low risk to patients of all ages, and its ability to generate quantitative data.

Eligibility Criteria:
Inclusion Criteria:

* Healthy term newborns (37-42 weeks gestation at delivery) in the Assessment Nursery at Barnes-Jewish Hospital, St. Louis, MO
* Mother of a healthy term newborn who is enrolled in this study

Exclusion Criteria:

* Congenital abnormalities affecting skin, nails, or hair in the newborn infant
* Family history of a sweating disorder
The Sentinel Registry

This registry is to evaluate procedural outcomes and safety outcomes of cerebral protection devices during transfemoral TAVR in real-world clinical practice.

The data from this registry will be compared with the extracted data from the TP TAVR registry(NCT038262664) using Propensity Score Matching.


Eligibility Criteria:
Inclusion Criteria:

* Age 19 and more
* Undergoing TAVR with the use of SENTINEL embolic protection device
* Higher risk of cerebrovascular embolic events (any of the followings)

  1. Bicuspid aortic valve
  2. Calcified lesion or atherosclerosis in the ascending aorta and/or aortic arch
  3. Heavy calcified aortic valve (Ca. volume \> 500)
  4. Chronic kidney disease
  5. Prior stroke
  6. Stroke risk is strongly anticipated by attending physicians
* Compatible carotid and brachiocephalic artery anatomy for SENTINEL device as determined by Multi-Slice Computed Tomography scan or equivalent imaging modality
* Agrees to the study protocol and the schedule of clinical follow-up and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

* Vasculature in the right extremity precluding radial or brachial access
* Excessive tortuosity in the right radial/brachial/subclavian artery preventing Sentinel System access and insertion
* Inadequate circulation to the right extremity as evidenced by signs of artery occlusion (modified Allen's test) or absence of radial/brachial pulse
* Hemodialysis shunt, graft, or arterio-venous fistula involving the upper extremity vasculature
* Symptomatic or asymptomatic severe occlusive carotid disease requiring concomitant carotid endarterectomy/stenting
* Undergone carotid stenting or carotid endarterectomy within the previous 6 weeks
* Concurrent medical condition with a life expectancy of less than 1 year
Gastric Volumes After Oral Multimodal Analgesia in the Pre-operative Setting: A Prospective Case Series

To assess possible risk of aspiration with pre-operative oral medications taken with "sips" of water (100ml).


Eligibility Criteria:
Inclusion Criteria:

* Patients able to take prescribed oral multimodal analgesia as per standard of care

Exclusion Criteria:

* BMI \> 40
Study of the IDO Pathway Inhibitor, Indoximod, and Temozolomide for Pediatric Patients With Progressive Primary Malignant Brain Tumors

This is a first-in-children phase 1 trial using indoximod, an inhibitor of the immune "checkpoint" pathway indoleamine 2,3-dioxygenase (IDO), in combination with temozolomide-based therapy to treat pediatric brain tumors. Using a preclinical glioblastoma model, it was recently shown that adding IDO-blocking drugs to temozolomide plus radiation significantly enhanced survival by driving a vigorous, tumordirected inflammatory response. This data provided the rationale for the companion adult phase 1 trial using indoximod (IND#120813) plus temozolomide to treat adults with glioblastoma, which is currently open (NCT02052648). The goal of this pediatric study is to bring IDO-based immunotherapy into the clinic for children with brain tumors. This study will provide a foundation for future pediatric trials testing indoximod combined with radiation and temozolomide in the up-front setting for patients with newly diagnosed central nervous system tumors.


Eligibility Criteria:
Eligibility Criteria

* Age: 3-21 years.
* Group 1 or Group 3: histologically proven initial diagnosis of primary malignant brain tumor, with no known curative treatment options.
* Group 2: histologically proven initial diagnosis of high-grade glioma (WHO grade III and IV), ependymoma, medulloblastoma, or other primary central nervous system tumor.
* Group 3b: Patients with a radiographic diagnosis or histologically proven diagnosis of diffuse intrinsic pontine glioma (DIPG).
* MRI confirmation of tumor progression or regrowth.
* Patients must be able to swallow whole capsules.
* Patients with metastatic disease are eligible for enrollment.
* Lansky or Karnofsky performance status score must be \> 50%.
* Seizure disorders must be well controlled on antiepileptic medication.
* DIPG patients enrolled to Group 3b must not have been previously treated with radiation or any medical therapy.
* Patients previously treated with temozolomide, cyclophosphamide, and/or etoposide are eligible for enrollment.

Exclusion Criteria

* Prior invasive malignancy, other than the primary central nervous system tumor, unless the patient has been disease free and off therapy for that disease for a minimum of 3 years
* Patients with baseline QTc interval of more than 470 msec at study entry, and patients with congenital long QTc syndrome.
* Active autoimmune disease
Effect of Bio-electromagnetic Energy Regulation Therapy on Erectile Dysfunction in Patients With Multiple Sclerosis

Multiple sclerosis (MS) is an inflammatory disease that affects the brain and spinal cord. There are potential impacts on neurological functions, including sensory and autonomic functions. The Primary observed in males with MS is erectile dysfunction (ED), which substantially impacts the quality of life. There is increasing literature on electromagnetic fields' biological and clinical effects, particularly on ED.

The study aims to examine the bio-electromagnetic energy regulation therapy (BEMER) on erectile dysfunction with MS. We will recruit participants with MS having ED in a Triple-blind randomized clinical trial study. All participants will be randomly assigned to either an experimental group (receive the BEMER therapy) or a comparison group (receive placebo BEMER therapy) for five days/week for three weeks. Participants will also receive pelvic floor exercises in both groups.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MS according to the McDonald Revised criteria.
* Score 6-25 on the International Index of Erectile Function 15 (IIEF-15) will be recruited.
* Had sexual activity in the past month.
* Have Relapsing-remitting MS (RRMS) type and one month of clinical relapse, at least before the experimental study date.

Exclusion Criteria:

* If they have cognitive impairment that causes problems in answering the questionnaire.
* History of major chronic illness or other neurological disorders.
* Received any treatment for ED in the past seven days
* Previous therapy with a pulsed electromagnetic field, epilepsy, pacemaker, and acute bacterial infection with fever.
Effect of Flamingo Exercises on Balance

The aim of this study is to determine the effect of flamingo exercise on balance in patients with balance impairment due to senil osteoarthritis

Changes in the sensory, neurological, and musculoskeletal systems in older adults affect several motor tasks,including postural balance. Also osteoarthritis contribute to this process. Older people can gain balance disorders. The flamingo balance exercise is a full lower body workout utilizing many major muscle groups. Therefore investigators aimed to determine the effect of flamingo exercise combined with kinesthetic ability trainer or alone in patients with balance impairment due to osteoarthritis

Eligibility Criteria:
Inclusion Criteria:

* Older than 65 years old
* osteoarthritis diagnosis
* Balance impairment (Berg balance scale 21-40 points)

Exclusion Criteria:

* Severe neurological deficit
* Defect of vision
* Vitamin B12 deficiency
* Sedative drug use
Online Wellness Intervention for Primary Biliary Cholangitis (PBC)

Primary biliary cholangitis (PBC) is a chronic autoimmune condition of the liver. Persons with PBC have high rates of liver disease-related symptoms and poor health-related quality of life - amongst the lowest of all chronic liver diseases. Patients and the Canadian PBC Society have identified the need for self-care tools to manage symptom burden. Building upon a previously developed online wellness program for inflammatory bowel disease (IBD), the researchers have developed a mind-body wellness module specific for patients with PBC. The 12 week module will be delivered online, and each week is made of an introduction video, 15-20 minutes of yoga, 10-15 minutes of meditation, behavior change tips, and nutrition tips. In a pre-post single arm feasibility study, the researchers will assess how acceptable this module is to patients through looking at rates of refusal, completion rates, and patient feedback. At the beginning and the end of the 12-week research study, participants will complete surveys to assess exploratory outcome measures including stress, anxiety, depression, resilience, quality of life, fatigue, and perceived ability to participate in the 12 week module. After the program, the research team will conduct interviews with participants to allow them to share their other feedback about the program. The researchers will also send surveys to the participants one month after the program ends to asses their continued satisfaction with and adherence to the program.


Eligibility Criteria:
Inclusion Criteria:

* Adults (≥18 years)
* Identified diagnosis of PBC
* HADS score \<=10
* English language proficiency to complete questionnaires and read the educational material
* Access to the Internet and a computer or smart device at home.

Exclusion Criteria:

* Patients with a major medical co-morbidity
* Inability to provide informed written consent
* Severe psychiatric disorders (HADS scores \>10)
Chemotherapy in Treating Patients With Advanced Solid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of chemotherapy using sarCNU in patients who have advanced solid tumors.

OBJECTIVES: I. Determine the maximum tolerated dose of SarCNU in patients with advanced solid malignancies. II. Determine the toxic effects of SarCNU in these patients. III. Characterize the pharmacokinetic profile of this regimen in these patients. IV. Determine any evidence of antineoplastic activity of this regimen in these patients.

OUTLINE: This is a dose-escalation study. Patients receive oral SarCNU on days 1, 5, and 9. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of SarCNU until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at the MTD.

PROJECTED ACCRUAL: Approximately 12-36 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed advanced solid malignancy for which no curative or life-extending therapy exists No prior or concurrent CNS metastases Primary CNS tumors allowed if on a stable dose of steroids at least 2 weeks before study entry No myelodysplastic syndrome

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: More than 12 weeks Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 120,000/mm3 Hemoglobin greater than 8 g/dL Hepatic: Bilirubin normal AST and ALT less than 2.5 times upper limit of normal Renal: Creatinine less then 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No uncontrolled cardiac disease No uncontrolled hypertension Pulmonary: DLCO and vital capacity greater than 80% predicted Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative Oral intake at least 1,200 calories per day No recent weight loss of more than 10% actual body weight No serious concurrent illness No uncontrolled infection

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy No concurrent immunotherapy No concurrent immunomodulating agents Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) No other concurrent cytostatic or cytotoxic chemotherapy Endocrine therapy: See Disease Characteristics No concurrent hormonal therapy No concurrent dexamethasone Radiotherapy: At least 3 weeks since prior radiotherapy No prior radiotherapy to more than 25% of bone marrow No concurrent radiotherapy Surgery: At least 3 weeks since prior major surgery
Phase 3 Clinical Trial of Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2(Trafermin)

This study aims to verify the effectiveness of Trafermin (recombinant human basic fibroblast growth factor) in stimulating regeneration of periodontal tissue lost by periodontitis and to evaluate the safety of such stimulation.


Eligibility Criteria:
Inclusion Criteria:

* Probing pocket depth 4mm or deeper
* Vertical intrabony defect 3 mm or deeper from radiographs at baseline
* Mobility of tooth 2 degree or less

Exclusion Criteria:

* Using an investigational drug within the past 24 months
* Coexisting malignant tumour or history of the same
* Coexisting diabetes (HbA1C 6.5% or more)
* Taking bisphosphonates
* Coexisting gingival overgrowth or history of the same
Study Vitamin D in Healthy Individuals

To obtain sufficient specimens and correlating clinical data from a well-controlled prospective clinical trial collecting specimens from healthy subjects t on vitamin D assays, and to establish a collection of specimens that will support future assay discovery and validation efforts.

1. Obtain matched serum and plasma specimens collected from a minimum of 50 healthy subjects in two geographic areas. Specimens will be used to determine a reference range for a vitamin D assay, used as an aid in the assessment of vitamin D sufficiency in adults.
2. Obtain serum specimens collected from a minimum of an additional 450 healthy subjects in two geographic areas. Specimens will be used to determine a reference range for a vitamin D assay, used as an aid in the assessment of vitamin D sufficiency in adults.
3. To store any remaining specimens for use in future vitamin D assay development and to evaluate as yet undetermined assays for the development of IVDs, including additional vitamin D assays

Eligibility Criteria:
Inclusion Criteria:

Males and females, age≥ 18 years Able to understand and willing to provide informed consent

Exclusion Criteria:

Males and females, age \<18 years Current use of dietary supplements (tablet, liquid gel or liquid form only) containing high concentrations, greater than 2,000 IU per day, of vitamin D.

Has a history of vitamin D deficiency Has a history or current diagnosis of any clinically significant cardiac, respiratory, neurological, immunological, hematological, liver disease, renal disease, gastrointestinal (GI) disorder, including any history of peptic or gastric ulcers or GI bleeding, or any other condition which, in the opinion of the investigator is considered chronic.

Personal history of seizures Personal history of bariatric surgery Personal history of parathyroid and thyroid disease Pregnancy or lactation Is receiving systemic chemotherapy or radiation treatment, has an active malignancy of any type, or has been diagnosed with cancer within 5 years before screening other than basal or squamous cell skin cancers or in-situ cervical cancer.

Family history of parathyroid or calcium regulatory disease Medications known to affect absorption e.g. drugs that inhibit cholesterol absorption Medications known to increase catabolism such as anticonvulsants, glucocorticoids, HAART (AIDS treatment) and anti-rejection medications Unable to provide informed consent