cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Efficacy of Blue Fenugreek Kale Extract (BFKE) on Skin

Participants will be supplemented BFKE for a period of 8-weeks to improve skin health. The objective of the study is to evaluate the 'Transepidermal Water Loss (TEWL)' that characterizes the skin barrier function of stratum corneum. Additional parameters include, evaluation of skin moisture content, wrinkling, elasticity, sagging, radiance and also on inflammatory biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, adult female participants aged ≥ 30 and ≤ 55 years.
* Participants with signs of poor skin barrier as determined by Trans-epidermal water loss ≥ 15 g/m2/h on forehead.
* Participants with skin type II to IV as per Fitzpatrick skin type calculator.
* Participants with skin type II and III as per Glogau's classification of photoageing skin.
* Participants must have Body Mass Index (BMI) ≥ 18.5 ≤ 29.9 kg/m2.
* Participants with moderate signs of Melasma as assessed by the investigators.
* Participants ready to abstain from any cosmetic or drug-based cream, ointment, lotion and other products apart from the ones allowed during study period.
* Participants ready to rinse their face only with water and to refrain from using soap, facewash, make-up etc. or any other cosmetic care related products 12 hrs. prior to any assessment visit.

Exclusion Criteria:

* Unwilling to forgo any aesthetic or dermatological treatments or procedures during the study period.
* Participants with visible scarring on face.
* Participants having any form of skin disorder on the Nasolabial fold.
* Water consumption history of ≤ 500 ml and ≥ 3000 ml per day.
* Smoking or using any tobacco products.
* Participants presently undergoing or had undergone treatment for softening or reducing wrinkles in the last 3 months.
* Having a history of chronic skin allergies.
* History of heavy caffeine usage ≥ 4 cups in a day.
* Binge drinkers as defined by consumption of 4 or more alcohol containing beverages within 2 hours.
* Presence of unstable, acutely symptomatic, or life-limiting illness.
* Participants taking any vitamins and other related supplements.
* Menopausal and peri-menopausal females.
* Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
* Females who have had participated in a study of an investigational product 90 days prior to the screening.
Negative Pressure Wound Therapy - A Multi-Centered Randomized Control Trial

Children with neuromuscular disorders such as cerebral palsy, children with kyphosis and post-traumatic scoliosis have higher infection rates after scoliosis surgery than healthy children who undergo scoliosis surgery. The purpose of our study is to compare the effect of NPWT on infection rates when compared to standard gauze dressing. Participants will be randomized to the "NPWT" or "standard dressing" group. We will compare infection rates between the two groups. We hypothesize participants in the "NPWT" group will have a lower infection rate.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Consent/assent to participate in the study
* Undergoing posterior spinal surgery categorized as High-Risk for infection, defined as greater than 4% risk of deep or superficial infection based previous reported literature. Procedures qualifying for study are listed below:
* Kyphosis (any type)
* Posttraumatic Scoliosis
* Neuromuscular Scoliosis

Exclusion Criteria:

* Previous incisions over the operative site
* History of keloid formation
* Allergy to tape
* Does not consent/assent to participate in the study
* Previous or Active Spinal infection
* Dural tear
* Hemophiliac
* Two Stage procedure
* Unable to follow standard antibiotic protocols
Concentrations of Voriconazole in Blood and BAL-fluid After Inhalation and Oral Administration

Concentrations of voriconazole in pulmonary epithelial lining fluid and in serum are compared after inhalation of 40 mg voriconazole b.i.d. for two days or oral intake of voriconazole tablets 400 mg bid for 1 day followed by 200 mg b.i.d. for one day, respectively.


Eligibility Criteria:
Inclusion Criteria:

* Planned bronchoscopy in relation to work-up after hemoptysis or other symptom leading to bronchoscopy
* Informed written consent
* Performance status 0-1
* Ct scan of thorax without suspicion of malignancy
* Weight t ≥ 60 og ≤ 130 kg
* Male gender or female gender in postmenopausal state defined by amenorrhea in more than 12 months.

Exclusion Criteria:

* Voriconazole treatment up to one week before inclusion
* Se-creatinin≥ 100 uM
* ALAT ≥ 70 U/l
* QT-interval \> 480 ms
* Allergic reaction to voriconazole or constituents in Vfend
* Allergic reaction to other azoles
* Ischemic Heart disease, Heart failure or uncontrolled hypertension
* Treatment with statins or omeprazole, which cannot be paused for three days during voriconazole exposure
* Treatment with Efavirenz, rifabutin, ritonavir, everolimus, methadon, alfentanil, fentanyl, sufentanil, oxycodone, hydrocodone, fluconazole, aztemizol, cisaprid, pimozid, quinidine, terfenadine, carbamazepine, phenobarbital, mephobarbital, ergotamine, dihydroergotamine, rifampicine, st. johns worth, everolimus, phenytoin, warfarin, phenprocoumon, acenocoumarol, benzodiazepines as midazolam, triazolam, alprazolam, sirolimus, cyclosporine, tacrolimus, ibuprofen, diclofenac,tolbutamide, glipizide, vincristine, vinblastine or other vinca alkaloids, HIV-protease Inhibitors e.g. saquinavir, amprenavir and nelfinavir, delavirdine, nivrapine and other non-nocleaoside revers transcriptase inhibitors
Lung Function of Asthmatic Children by Nebulized MgSO4

Asthma is a common chronic respiratory illness which results in frequent wheezing, cough,reduced quality of life. Standard treatment for asthma attack includes oxygen therapy, β2-agonists (e.g. albuterol) and inhaled anticholinergics and corticosteroids. Although inhaled short-acting β2-agonists (SAB) is the initial choice to control acute asthma exacerbation, there are still some asthmatic children unresponsive to this management. The Global Initiative in National Asthma (GINA) does not recommend intravenous magnesium sulfate (MgSO4) for routine use in asthma exacerbation especially in young children. But intravenous MgSO4 can reduce hospital admission rates in certain patients due to several effects e.g relaxation of smooth muscle,blocking acetylcholine. In addition,adding MgSO4 to nebulized SAB provides greater benefit in severe asthma exacerbation.


Eligibility Criteria:
Inclusion Criteria:

* asthmatic children with controlled clinical manifestation

Exclusion Criteria:

* fever
* history of chronic disease like bronchopulmonary dysplasia or cystic fibrosis
* allergic to acetylcholine, albuterol or magnesium
* use any bronchodilator agents before the Clinic day
Effect of Trunk Stabilization Exercises on Quality of Life and Communication in Cerebral Palsy

To investigate the effectiveness of neck and trunk stabilization exercises on communication and quality of life (QoL) in children with cerebral palsy (CP) with oral motor problems. Children with CP were randomly divided into Study Group (SG) and Control Group (CG). Neurodevelopmental treatment (NDT) approaches and oral motor therapy were applied to both groups. SG also received neck-trunk stabilization training.

In the multidisciplinary approach, special approaches to secondary problems, oral-motor trainings and communication studies are used in addition to Neurodevelopment treatment approach in the treatment of children with CP. Because of their impact on postural control, neck-trunk stabilization exercises are very important for therapeutic interventions designed to improve quality of life with activities of daily living.

As the increases in neck muscle strength are related to trunk stabilization, trunk stabilization exercises are thought to have positive effects on neck muscle strength. In addition, since the neck and trunk are complementary to each other, it is supported by the literature that neck stabilization exercises and trunk stabilization exercises should be applied together.

Eligibility Criteria:
Inclusion Criteria:

* 1.5 years and older,
* Lack of cooperation problem to prevent communication,
* To have been diagnosed with cerebral palsy and admitted to the hospital for routine control,
* Volunteer to participate in the research,
* Existence of at least one of the items of the "Key Questions" interrogation system showing feeding/swallowing problems in children with cerebral palsy.

Exclusion Criteria:

* Presence of severe vision and hearing loss,
* Use any pharmacological agent to inhibit spasticity,
* He/she had undergone orthopedic surgery or Botulinum Toxin-A injection in the last six months.
Choose to Lose for Women-Weight Loss to Reduce Breast Cancer Risk Factors

This study is investigating the changes in specific hormone levels in women age 30-45 after a 12 week weight loss intervention.

In sum, excess body weight and inactivity have emerged as strong avoidable causes of postmenopausal breast cancer, with the greatest potential for primary prevention occurring during the premenopausal years. However, surprisingly, no study to date has examined the effects of a standard behavioral weight loss intervention on breast cancer risk markers in premenopausal women. Understanding the effects of weight loss in premenopausal women is a critical next step in existing research and will inform the development of future breast cancer primary prevention programs. The purpose of this study is to determine the feasibility of recruiting, treating, and retaining 20 overweight/obese women in a 12-week randomized control trial examining feasibility and effects of a behavioral weight loss program on breast cancer risk markers in premenopausal women. Participants will be randomly assigned to either a 12-week comprehensive behavioral weight loss program (n=10) or control condition (n=10). All women will be assessed at baseline and after 3 months of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women
* Age 30-45
* Current BMI of \>25
* English or Spanish speaking
* 5th grade reading level
* Menstrual regularity, defined as menstrual cycle length of 27-31 and \< 1 missed period within the past 12 months.

Exclusion Criteria:

* Current use or recent (\< 6 months) use of oral contraceptives, hormones, or other hormone-influencing medications
* Pregnant, lactating or planning pregnancy in the next 12 weeks
* Unwilling and able to location for intervention visits.
* Serious medical condition requiring the supervision of a physician for exercise and diet
* History of eating disorder
* History of or current use of drugs
* Current treatment for serious psychological disorder
* Donation of blood within past 6 weeks.
Patient Registry of Roflumilast In Real Life

A patient registry to capture real life data and demonstrate the performance of roflumilast (Daxas®) in a standard clinical practice.

The drug being tested in this observational study design is called roflumilast, but not as an therapeutic intervention. Roflumilast is approved for and marketed globally for maintenance treatment of severe Chronic Obstructive Pulmonary Disease (COPD) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment.

This study will capture real life data and demonstrate the performance of roflumilast in a standard clinical practice. The study will enroll approximately 1350 (EU)+600(North Asia) patients. This multi-centre trial will be conducted in at least 4 EU and 2 North Asian countries.

The overall time to participate in this study is 12 months. No visits, diagnostic procedures or monitoring will take place, which would not happen had the patient not been included in the study.

Participants will be followed according to usual practice and data recorded approximately at 6 months and at 12 months of roflumilast treatment.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent to the data collection
* Roflumilast (Daxas®) treatment initiated in Roflumilast (Daxas®) naïve patients at the time of registry

Exclusion Criteria:

There are no exclusion criteria per se. However it is expected that patients are treated according to locally approved marketing authorisation.
A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis

The study has been designed with three components. Part A is an open label PK study followed by a randomized trial component (Part B) followed by open label Long Term Extension (LTE).

The initial PK analysis is first done in adolescent subjects (12 to \<18 years) before initiating the PK study in younger cohort (6 to \<12 years)


Eligibility Criteria:
Inclusion Criteria:

* Subject must be 6 to \< 18 years of age, of either sex, of any race/ ethnicity, must weight greater than or equal to 15Kg.
* Diagnosis of predominantly plaque psoriasis for ≥6 months (as determined by subject interview and confirmation of diagnosis through physical examination by investigator).
* Moderate to severe psoriasis at baseline defined as: at least 10% Body Surface Area (BSA) involvement, PGA score ≥ 3, and PASI score ≥ 12
* Subject must be considered a candidate for systemic therapy, meaning psoriasis inadequately controlled by topical treatments (corticosteroids), and/or phototherapy, and/or previous systemic therapy
* Subject is considered to be eligible according to tuberculosis (TB) screening criteria
* A maximum of 2 QuantiFERON tests will be allowed. A re-test is only permitted if the first is indeterminate; the result of the second test will then be used.

Exclusion Criteria:

* Subject has predominantly non-plaque forms of psoriasis specifically erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new-onset guttate psoriasis
* Subject has laboratory abnormalities at screening including any of the following: Alanine transaminase (ALT) or aspartate transaminase, (AST) ≥2X the upper limit of normal, Creatinine ≥1.5X the upper limit of normal serum direct bilirubin ≥ 1.5 mg/dL, white blood cell count \< 3.0 x 103/μL, and any other laboratory abnormality, which, in the opinion of the Investigator, will prevent the subject from completing the study or will interfere with the interpretation of the study results
* Subject who is expected to require topical therapy, phototherapy, or additional systemic therapy for psoriasis during the trial
* Female subjects of childbearing potential who are pregnant, intend to become pregnant (within 6 months of completing the trial), or are lactating. (Sexually active adolescent girls will be required to use contraception)
* Subject with presence of any infection or history of recurrent infection requiring treatment with systemic antibiotics within 2 weeks prior to Screening, or severe infection (e.g. pneumonia, cellulitis, bone or joint infections) requiring hospitalization or treatment with IV antibiotics within 8 weeks prior to Screening
* Positive human immunodeficiency virus (HIV) test result, hepatitis B surface (HBS) antigen, or hepatitis C virus (HCV) test result
Severe Proliferative Diabetic Retinopathy

The purpose of this study is to examine and compare, prospectively, best corrected visual acuity (BCVA) outcomes and complications of a cohort of patients with Proliferative Diabetic Retinopathy and Tractional Retinal Detachment not involving macula undergoing pars plana vitrectomy (PPV) or conventional management (panretinal photocoagulation).

The utility and practice of Panretinalphotocoagualtion (PRP) in patients with high-risk Proliferative Diabetic Retinopathy (PDR) have not changed since the ETDRS reported guidelines in 1987. A meta-analysis of the DRS and ETDRS two large U.S. RCT of laser therapy for PDR confirmed the effectiveness of PRP (Level I evidence). Both trials had large sample sizes, excellent compliance and adequate follow-up. These studies established that PRP reduces the risk of severe visual loss in patients with high-risk PDR by 50% to 60%20.

With the arrival of the vitrectomy, this surgery was often used to treat eyes with severe complications from PDR. The most common indications for vitrectomy were nonclearing vitreous hemorrhage, Tractional Retinal Detachment(TRD) with macular involvement, and combined traction and rhegmatogenous retinal detachment. With the addition of new indications to the known indications vitrectomy has been performed in earlier stages(severe PDR). A large number of case series reports have assessed the effect of pars plana vitrectomy on diabetic TRD with or without macular detachment but the level of evidence was low and they included patients not homogeneous. These studies have generally shown benefit, with improved vision seen in many patients (ranging from 22% to 65%) but they have also indicated a high rate of operative and postoperative complications. These numerous intra and post-operative complications could lead to satisfying anatomical results but poor vision.The purpose of this study is to examine and compare, prospectively, best corrected visual acuity (BCVA) outcomes and complications of a cohort of patients with Proliferative Diabetic Retinopathy and Tractional Retinal Detachment not involving macula undergoing pars plana vitrectomy (PPV) or conventional management (panretinal photocoagulation)

Eligibility Criteria:
Inclusion Criteria:

* Eyes with advanced Proliferative diabetic retinopathy some with TRD not involving the macula. The definition of severe PDR included eyes with extensive, active neovascular and fibrovascular proliferation graded using Modified Airlie House Classification

Exclusion Criteria:

* Eyes with fibrovascular tractional detachment involving the macula were excluded. Eyes with a combined tractional and rhegmatogenous retinal detachment and eyes with a history of uveitis or trauma, with previous vitrectomy and neovascular glaucoma were also excluded.
Vitamin D and Glucose Metabolism in Pediatrics

The discovery that the vitamin D receptor is expressed in more than 30 tissues indicates that the physiologic functions of vitamin D are much broader than its well-known role in the regulation of calcium absorption and bone metabolism. There is evidence that vitamin D is involved in the pathogenesis of cancer, cardiovascular disease, multiple sclerosis, and type I diabetes. Recent epidemiological evidence points to a strong association between vitamin D insufficiency and insulin resistance, the metabolic syndrome, and type II diabetes. The investigators would like to examine the role of vitamin D in the development of insulin resistance in overweight children and adolescents, which represent a high risk population for cardiovascular and metabolic complications. The investigators propose a prospective randomized clinical trial of vitamin D supplementation in overweight, insulin resistant, vitamin D deficient children. The investigators objective is to assess if changes in insulin resistance, fasting lipid profiles, blood pressure, and inflammatory markers occur in these patients post treatment with vitamin D. Additionally, concomitant changes in calcium and bone metabolism after vitamin D treatment will be evaluated. This is because, contrary to adults, the optimal vitamin D concentrations that regulate calcium and bone metabolism have not been established in pediatrics.


Eligibility Criteria:
Inclusion Criteria:

1. BMI\>85th% for age \& sex
2. Vitamin D25 between 10-20ng/ml
3. Normal serum Ca concentrations \>8.5mg/dl
4. Evidence of insulin resistance (measured by HOMA-IR, and QUICKI indices)

Exclusion Criteria:

1. Vitamin D25\<10ng/ml
2. No parental consent
3. No evidence of insulin resistance
4. BMI \< 85th percentile
5. Known diagnosis of type 1 or 2 diabetes
6. Severe underlying disease such as liver disease, end-stage renal disease, or malignancy
7. Present medication that affects insulin sensitivity such as steroids or Metformin
8. Any chronic illness or administration of medications that is associated with fat malabsorption as they may interfere with vitamin D absorption.
9. Known history of hypocalcemia, calcium disorder (such as Di George syndrome)
10. Serum Calcium concentration \< 8.5mg/dl
11. Other drugs that might effect vitamin D metabolism due to induction of P450 enzyme activity.
TACE Combined With Immune Checkpoint Inhibitors for Liver Malignant Tumors

This study will evaluate the efficacy and safety of TACE combined with immune checkpoint inhibitors to treat unresectable hepatocellular carcinoma.

The specific operation of TACE is based on the CSCO Diagnosis and Treatment Guidelines for Primary Liver Cancer (2022 Edition). TACE is performed through microcatheters. After TACE, the coaxial catheter is retained in the hepatic artery or left or right hepatic artery branch. The specific body plan is oxaliplatin+calcium folinate+5-Fu (FOLFOX) (J Hepatol, 2018). Oxaliplatin 85mg/m2 was continuously injected through arterial pump for more than 4 hours on the first day. After HAIC is completed, remove the catheter and sheath. Repeat catheterization in the next treatment cycle.

Immune checkpoint inhibitors can be administered arterial starting after the first TACE treatment, q4w (± 3 days). If the situation requires, the arterial administration of ICI can be adjusted forward or backward for 7 days to adapt to TACE treatment.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of HCC by histology/ cytology or clinical criteria
* Sign informed consent
* When screening for age, the age should be ≥ 18 years old
* Eligible for TACE treatment
* ECOG physical condition score is 0 or 1
* No prior systemic therapy for HCC, especially immunotherapy
* According to the following mRECIST criteria, at least one measurable intrahepatic lesion is suitable for repeated evaluation

Exclusion Criteria:

* Have any history of kidney disease or nephrotic syndrome
* Evidence of extrahepatic spread (EHS)
* Cardiovascular diseases with clinical significance (such as activity), including unstable angina, ≥ grade 2 congestive heart failure, and arrhythmia with poor drug treatment control
* Any condition representing a contraindication to TACE as determined by the investigators
* Known genetic factors for bleeding or thrombosis; Any previous or current evidence indicating a tendency for bleeding
* Individuals who have received immunotherapy (anti PD-1, anti PD-L1, or anti CTLA-4 treatment)
* Previously received HAIC (hepatic artery infusion chemotherapy), TACE (hepatic artery chemoembolization), TAE (hepatic artery embolization), or TARE (hepatic artery radiation embolization)
* Previously received systemic anti-cancer treatment for HCC ,ICC or liver metastasis.