cyrilzakka/clinical-trials huggingface dataset:
Assessement of the Soothing Effect of a Food Supplement on Sensitive and Reactive Skin

The study is aimed to assess the soothing effect of a food supplement composed of Coriander Seed Oil (CSO) in terms of reducing skin redness and skin discomfort (stinging feeling) on sensitive and reactive skin.

A double blind, parallel groups, placebo-controlled study is carried out on 80 female subjects aged between 18 and 65 years old with sensitive and reactive skin.

The study foresees 56 days of products intake. Evaluations of the parameters under study are performed at baseline, after 14, 28 and 56 days of products consumption.

Eligibility Criteria:
Inclusion criteria :

* Good general health
* Caucasian ethnicity
* Female sex
* Phototype I to IV
* Sensitive and reactive skin (showing positive answer from 3-moderate to 4-strong to stinging test performed with a 10% lactic acid solution)
* Age between 18 and 65 years old (subject with 18 and 65 years old can be included)
* Subjects who have not been recently involved in any other similar study (evaluation is performed case by case by the experimenter but at least 1 month must be elapsed between a previous study on food supplement)
* Willingness to use during all the study period only the products to be tested
* Willingness not to use similar products that could interfere with the product to be tested
* Willingness to not vary the normal daily routine (i.e. lifestyle, physical activity, diet etc.)
* Subjects under effective contraception (oral/not oral) if women of childbearing potential; not expected to be changed during the trial
* Subject aware of the study procedures and having signed an informed consent form
* Subjects who accept not to expose in intensive way to UV rays during the whole study duration
* Subjects who have not involved in any sun test (for SPF evaluation) or tests that provide skin irradiation since less than two months

Exclusion Criteria:

* Subject does not meet the inclusion criteria,
* Pregnant/breastfeeding female or who have planned a pregnancy during the study period
* Subjects under systemically pharmacological treatment
* Subjects under locally pharmacological treatment on the skin area monitored during the test
* Subjects with congenital or acquired immunodeficiency
* Subjects under treatment with food supplements which could interfere with the functionality of the product under study
* Subjects which show skin alterations on the monitored area which could interfere with the functionality of the product under study
* Subjects considered as not adequate to participate to the study by the investigator
* Subjects with known or suspected sensitization to one or more test formulation ingredients
* Adult protected by law (under control or hospitalized in public or private institutions for reasons other than research, or incarcerated)
* Subjects not able to communicate or cooperate with the investigator for problems related to language, mental retardation or impaired brain function
Medication Adherence and "True" Resistance in Patients With Resistant Hypertension

The purpose of this study is to estimate the proportion of patients with "true" resistance among patients referred to the Medical Outpatient Department of the Charité - Universitätsmedizin Berlin with the diagnosis "resistant hypertension". Moreover, data on medication adherence will be collected based on therapeutic drug monitoring and on the answers to validated questionnaires. Finally, efficacy, safety and costs of renal sympathetic denervation will be compared to an intensified drug treatment in an exploratory way.


Eligibility Criteria:
Inclusion Criteria:

* Female or male adult patients with arterial hypertension and admission diagnosis of "resistant hypertension"
* Informed consent
* Exclusion of secondary arterial hypertension
* Kidney function (estimated glomerular filtration rate \[eGFR\] ≥ 45 ml/min/1.73 m2)

Exclusion Criteria:

* Age \< 18 years
* Secondary arterial hypertension
* Type 1 Diabetes mellitus
* Unstable coronary heart disease, myocardial infarction or stroke in the last 6 months
* Psychiatric diseases
* Significant carotid stenosis (\> 70%)
* Pregnancy
* Chronic kidney disease (eGFR \< 45 ml/min/1.73 m2)
* Severe liver injury (elevation of transaminases more than twofold the upper limit of normal)
* Abuse of alcohol or illegal drugs
Investigation of Two Newly Developed 2-piece Convex Baseplates in Subjects With Ileostomy

The aim of the current investigation is to develop new soft and more flexible 2-piece convex ostomy appliances


Eligibility Criteria:
Inclusion Criteria:

1. Have given written informed consent and signed letter of authority.
2. Are at least 18 years of age and have full legal capacity.
3. Have had their ileostomy for at least 3 months.
4. Have used a 2-piece convex ostomy product during the last month.
5. Are willing and able to comply with investigation procedures.
6. Have an ileostomy with a diameter of 30 mm or less.
7. Have experienced leakage (seeping) under the baseplate at least 2 times during the last two weeks.

Exclusion Criteria:

1. Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
2. Currently receiving or have within the past 2 month received radio- and/or chemotherapy.
3. Currently receiving or have within the past month received local (peristomal area) or systemic steroid treatment.
4. Are pregnant or breastfeeding.
5. Have a loop ostomy (also called double-barrel or ostomy with two outlets).
6. Known hypersensitivity toward any of the test products.
7. Participating in other interventional clinical investigations or have previously participated in this investigation.
Investigating the Role of the Polyol Pathway in the Central Nervous System Production of Fructose

To investigate whether longer-term improvement of glycemic control in poorly controlled diabetes patients with a 12-week intensified insulin treatment regimen will lead to decreased polyol pathway activity.

Polyol pathway activity will decrease in diabetic individuals who undergo intensification of their insulin treatment regimens as reflected by lower baseline brain intracellular fructose levels and higher intracellular glutathione levels. Furthermore, following longer-term improved glycemic control, patients may also have down-regulation of the pathway as reflected by decreased production of intracellular fructose in response to hyperglycemic clamp.

Eligibility Criteria:
Inclusion Criteria:

* 15 Type 2 DM subjects with HbA1C \> 7.5%
* 15 Type 1 DM subjects with HbA1C \> 7.5%
* Age 18-60
* BMI ≥18 kg/m2
* Weight ≤ 285 pounds

Exclusion Criteria:

* Creatinine \> 1.5 mg/dL, Hgb \< 10 mg/dL, ALT \> 2.5 X ULN,
* untreated thyroid disease,
* uncontrolled hypertension,
* known neurological disorders,
* untreated psychiatric disorders,
* malignancy,
* bleeding disorders,
* current or recent steroid use in last 3 months,
* illicit drug use;
* for women: pregnancy, actively seeking pregnancy, or breastfeeding; inability to enter
* MRI/MRS
Exploring Psychometric Properties of a New Version of the 6MWT in the Acute Stroke Population

The purpose of this study is to assess inter- and intra-rater reliability of the 6MWT in people with acute stroke who require various levels of assistance with walking.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Primary diagnosis of an acute or hemorrhagic stroke
* Admitted into the acute or acute rehab setting and is appropriate for physical therapy services.
* Can ambulate with 1 person assistance and a device as needed, with no more than maximal assistance required. The patient must be able to independently advance the lower extremity forward, but can receive maximal assistance for blocking, bracing or postural control during ambulation.
* Can stand and/or ambulate for at least 6 minutes

Exclusion Criteria:

* Hemodynamically unstable
* Unstable medical co-morbidities such as: active bleeding, recurring seizures, uncontrolled hypertension (permissive HTN orders ok)
* Patients with bilateral acute stroke
* Patients who are unable to follow 1 step commands as determined by the screening physiatrist
* Orthopedic co-morbidities that place a weight-bearing restriction on the lower extremities such as acute fracture, joint replacement, or other musculoskeletal injury
* Any other condition that would limit a patient's ability to remain in a standing position with assistance for 6 minutes at a time.
Single Ascending Dose Study of MSD-001 in Healthy Participants

The purpose of this Phase 1 single ascending dose (SAD) study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamic profile of MSD-001 when administered orally to healthy adult participants.

This is a first in human, prospective, single center, double blind, placebo-controlled, single ascending dose study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MSD-001. The study will include two parallel parts, Part 1 and Part 2, stratified by CYP2D6 phenotype.

Eligibility Criteria:
Key Inclusion Criteria:

* Male or female healthy consented participants 18 to 55 years of age
* CYP2D6 phenotype established based on pharmacogenetic testing.
* Free from psychoactive drug use from 4 weeks before dosing and until the last follow up visit.

Key Exclusion Criteria:

* Any current clinically relevant, or history of, acute or chronic diseases inclusive of psychiatric disorders and relevant family history, which could interfere with the participant's safety during the trial, or expose them to undue risk, or which could interfere with the study objectives.
* Moderate to severe congestive heart failure, history of heart surgery, pulmonary hypertension, systemic hypertension (i.e., systolic BP \>139 mm hg, diastolic blood pressure \> 89 mm hg), pulse rate \> 90 bpm, clinically significant ECG abnormality, QTc \> 450 msec, myocardial infarction in the past year, or any other active or severe cardiovascular condition.
* Clinically significant personal or familial history of epilepsy, seizures, convulsions, or other seizure disorder (excluding febrile seizures as a child), previous head trauma or other risk factor for seizure.
* Use of any psychedelic drug in the three months prior to planned dosing or the occurrence of persistent psychological effects following the previous use of psychedelic drugs.
* Subject experiences severe anticipatory anxiety or is otherwise considered unfit for study.
* History of moderate or severe illicit substance abuse or dependence, or a positive test result(s) for alcohol and/or drugs of abuse at screening or admission to the clinical unit.
* Subject has received a prior investigational intervention, has had a history of relevant hypersensitivity or allergic reactions, and has donated and/or received any blood or blood products or experienced blood loss, that may interfere with the objectives of the study.
* Subject has a significant negative life event (e.g. loss of a loved one) in the past 6 months.
Nonalcoholic Fatty Liver Disease in Taiwanese Children

Nonalcoholic fatty liver disease (NAFLD) is an emerging and important disease in Taiwan. However, the prevalence and clinical characteristics have not been studied well. The purpose of this study is to resolve the aforementioned problem.

\[Study Subjects\] Obesity was defined as the BMI value \> 95 percentile by different age- and gender groups according to the standards of the Department of Health in Taiwan.

\[Data Collection\] The following data were obtained for each subject: age, gender, BMI, waist and hip circumference. BMI was calculated as body weight (kg)/ height (m2).

In fasting venous blood samples, we measured total serum bilirubin, alanine aminotransferase, aspartate aminotransferase, γ-glutamyltransferase, fasting glucose, triglyceride, total cholesterol,high-density lipoprotein cholesterol, insulin, glucose, and adiponectin.

\[Liver Ultrasonography\] All participants underwent an ultrasonographic study of the liver performed by one operator.

NAFLD was defined as the presence of an ultrasonographic pattern consistent with the following criteria: liver-kidney echo discrepancy, attenuated echo penetration and visibility of diaphragm, and obscure hepatic vessel structures.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of fatty liver

Exclusion Criteria:

* other hepatic diseases
Comparison of NN1250 With Insulin Glargine in Type 1 Diabetes

This trial is conducted in Europe and in the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of NN1250 (insulin degludec) in subjects with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes for 12 months or longer, hereof the last 3 months with injection based therapies
* Current treatment with any basal insulin (e.g. insulin glargine, insulin detemir, NPH insulin) using one or two daily injections and with three or more daily meal-time insulin injections (e.g. insulin aspart, insulin lispro, insulin glulisine, human insulin) used as bolus insulin therapy
* HbA1c maximum 10.0 % by central laboratory analysis
* Body Mass Index (BMI) below or equal to 35.0 kg/m\^2
* Ability to self-manage insulin therapy as assessed by confirmation (verbal confirmation at screening visit) of a changed insulin dose in the preceding two months prior to screening
* Ability and willingness to adhere to the protocol including performance of self measured plasma glucose (SMPG) profiles and self adjustment of insulin doses

Exclusion Criteria:

* Use within the last 3 months prior to Visit 1 of any antidiabetic glucose lowering drug other than insulin
* Cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
* Uncontrolled treated/ untreated severe hypertension (systolic blood pressure above or equal to 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure above or equal to 100 mmHg)
* Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
* Cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin cancer)
Medical Polypectomy and Predictors of Response

This is the first randomized parallel group clinical trial looking at oral prednisolone induced medical nasal polypectomy followed by maintenance on topical steroid therapy in patients with nasal polyposis. This study also looks at the effect of aspirin sensitivity and the factors linking nasal polyps with asthma. We have also taken baseline measurements of a variety of blood, surface and biopsy markers to assess for potential to predict steroid response. Finally, the still unchartered link between nasal polyps and asthma will be explored by measuring Staphylococcal superantigens in serum before and after treatment.


Eligibility Criteria:
Inclusion Criteria:

* male or female
* 18-75 years of age
* bilateral nasal polyposis Grade 2 and above
* with or without asthma
* with or without atopy or aspirin sensitivity
* written informed consent

Exclusion Criteria:

* unilateral nasal polyposis
* polypoid lesion suspicious of inverted papilloma, malignancy, Wegeners granulomatosis, sarcoidosis
* known or suspected hypersensitivity to fluticasone propionate or any other constituents of the Investigational Medicinal product (IMP).
* Any clinically significant medical condition or abnormality, which, in the opinion of the investigator, might compromise the safety of the subject or which might interfere with the study.
* significant (≥50%)septal deviation
* inability to comply with the requirements of the protocol
* females who are pregnant, lactating or planning to become pregnant.
BREATHE Free: a Pilot Feasibility Trial

The overall purpose of this pilot study is to assess the feasibility and acceptability of an in-person faith-based intervention to help people stop tobacco use. The study will address use of different types of tobacco products, such as smoking combustible cigarettes, cigarillos and little filtered cigars, and using/vaping electronic nicotine delivery systems (vape pens, e-cigs, and JUUL).

The intervention consists of 12 weekly meetings in which participants will go through BREATHE Free, a study guide curriculum designed to teach character strengths and promote resilience. This pilot research will provide information and practical lessons on how to improve Breathe Free implementation, increase engagement of the local people, and maximize their benefit.

The main questions it aims to answer are:

* Do participants find BREATHE Free curriculum acceptable, engaging and helpful to stop tobacco use?
* Do participants who complete BREATHE Free curriculum smoke fewer cigarettes per day?

Researchers will assign participants to either BREATHE Free curriculum or usual care.

Participants will:

* Be taught BREATHE Free curriculum or be given information and referral to tobacco quit line
* BREATHE Free group will attend 12 group meetings held on the university campus
* All participants will answer interview questions related to tobacco use, character strengths and resilience
* Expired Carbon Monoxide (CO) will be assessed in all participants.


Eligibility Criteria:
Inclusion Criteria:

* Daily use of one or more tobacco products
* Valid home address in Augusta or the CSRA
* Functioning telephone number
* Speak, read, write in English

Exclusion Criteria:

* Current use of tobacco cessation medications
* Enrolled in tobacco treatment program
Effect of Triple Antibiotic Paste as an Intracanal Medication With an Anti-Inflammatory Drug on Post-operative Pain.

The purpose of this study is to determine whether the use of triple antibiotic paste as intracanal medication with an anti-inflammatory drug, compared to a calcium hydroxide will reduce postoperative pain and intracanal bacteria or not in patients with asymptomatic necrotic teeth.

This trial is aiming to answer a clinical question whether in patients with asymptomatic necrotic teeth, the use of triple antibiotic paste as intracanal medication with an anti-inflammatory drug, compared to a calcium hydroxide, reduce postoperative pain and intracanal bacteria or not? trial design will be Randomized, controlled, double blinded, unicenter, parallel, two-arm, superiority trial with 1:1 allocation ratio.

Eligibility Criteria:
Inclusion Criteria:

1. Subject's age between 18-50 years.
2. Both male and female subjects.
3. Medically free and healthy subjects.
4. Mandibular and maxillary single rooted teeth.
5. Asymptomatic non vital teeth.

Exclusion Criteria:

1. Teeth with acute dentoalveolar abscess.
2. Subjects having more than one tooth that require root canal treatment.
3. Subjects that have taken analgesic, anti-inflammatory or antibiotic drugs during the 10 days prior to the start of treatment.
4. Pregnant females.
5. Subjects with systemic diseases who have endocrine diseases, Infectious diseases or Psychological disturbance.
6. Teeth with periodontal disease or pulp calcification.
7. Subjects taking chronic pain medications.
Safety Study of P28GST Treatment in Crohn's Disease Patients

This multicenter phase 2 clinical trial is designed to assess safety of P28GST (protein 28 Kd glutathion S Transferrase), aiming to control inflammation in moderate Crohn's Disease (CD), before or after intestinal resection surgery. P28GST is a parasite enzyme molecule from Schistosoma with potent immunogenic and anti-oxidant properties. Based on experimental evidence of its anti-inflammatory properties, the investigators hypothesized that administration of P28GST could protect against recurrence after intestinal resection surgery in CD.

To carry out this study, 24 moderate CD patients will be enrolled in a safety phase 2a study. CD patients will be included after intestinal resection surgery or in moderate Crohn's Disease (CD). Drug therapy will consisted in 3 injections of 100 µg of P28GST within 3 months (one injection per month). The main objective of this study is to follow-up monthly rate and seriousness of adverse events during one year. Secondary objectives are to control immunologic and inflammatory blood and tissue markers, appearance or not of a clinical recurrence assessed by CDAI (Crohn Disease Activity Index).

Eligibility Criteria:
Inclusion Criteria:

* Subjects between the ages of ≥18 years at inclusion.
* Subjects with ileal or ileo-colic CD without fistula
* Subjects operated or not
* CDAI score \< 220
* no concomitant treatment excepted salicylates
* Women of child bearing potential must be negative for pregnancy prior to study enrolment
* contraceptive means : females of childbearing potential as well as males are required to use adequate contraceptive methods for 6 months starting at the inclusion, i;e 4 months after the 3rd injection .
* No tobacco consumption (end date of tobacco consumption 8 days before surgery).
* Signed consent form
* French social security coverage.

Exclusion Criteria:

* Subject who use of azathioprine, anti-TNF (Tumor Necrosis Factor), methotrexate, Vedolizumab, Ustekinumab and other immunosuppressors for 8 weeks before first injection of P28GST
* Subject who use of corticosteroids for 15 days before first injection of P28GST
* Subject with history of vaccine hyper sensitivity or allergy.
* Subject with any other clinical manifestation determined by the investigator
* Subject wih AIDS, B or C hepatitis.
Iron Sucrose in Non-Dialysis Dependent (NDD-CKD) Pediatric Patients

The primary objective of this study is to assess the pharmacokinetics of Venofer (Iron Sucrose Injection) in NDD-CKD pediatric patients.


Eligibility Criteria:
Inclusion Criteria:

* Age \> or = 12 to \< or = 16 years
* Parent and/or legal guardian able to give informed consent
* Subject able to give written assent for participating in the study
* NDD-CKD defined as: kidney damage for 3 months or longer, or GFR \< 60 for 3 months or longer
* Hemoglobin indicative of anemia
* Ferritin indicative of iron deficiency anemia
* If appropriate, subject must be willing to use an accepted form of birth control from time of screening through the follow-up period

Exclusion Criteria:

* Known history of hypersensitivity to any component of Venofer
* Parenteral iron within 14 days of the screening visit
* Dialysis dependent-CKD
* Chronic or serious active infection
* Pregnancy or lactation
* Subjects with causes of iron deficiency anemia other than CKD
* Blood transfusion within the last month or anticipated during the study
* Body weight \< 55 pounds
* Received an investigational drug within 30 days before screening