cyrilzakka/clinical-trials huggingface dataset:
Sideritis Supplementation, Oxidative Stress and Health

The aim of the present clinical study is to estimate the efficacy of a Sideritis Scardica extract (SidTea+), derived from the Greek mountain Taygetos, in regulating antioxidant and health biomarkers in healthy adults.

Introduction: The mountain tea of genus Sideritis has more than 150 species, which are mainly distributed in the Mediterranean area. In the literature, extensive reference is made to the secondary metabolites of Sideritis, the main ones of which are terpenoids (i.e., iridoids and kauranes) and phenolic derivatives (i.e., flavonoids, phenolic acids, phenylethanoid glycosides). Polyphenols exhibit a wide range of biological activities, such as anti-atherogenic, anti-cancer, anti-mutagenic, anti-inflammatory and antimicrobial properties. Among phenolic derivatives, major significance is given to flavonoids, due to their antioxidant, anti-inflammatory, antibacterial, antiviral and anti-allergic properties in various pathologies. Flavonoids mainly act as antioxidants, inhibiting free radical-induced cytotoxicity and lipid peroxidation. Moreover, these compounds are known to inhibit tumor growth and proliferation and act as weak agonists or antagonists of estrogens by regulating endogenous hormonal activity. In these ways, they can protect against chronic diseases such as atherosclerosis and cancer and regulate menopausal symptoms.

Purpose: This study aims to investigate the effect of a Sideritis Scardica extract (SidTea+) supplement from the Greek mountain Taygetos on health and oxidative stress indicators in healthy individuals. The results of the present investigation will help to elucidate the effects of an extract derived from a plant product on markers of health and oxidative stress in apparently healthy individuals.

Methodology: 30 healthy individuals will be enrolled in the study. Participants will give their informed consent after they will be informed about the purposes, procedures, risks and benefits associated with the study. Participants will be randomly allocated to either a Sideritis spp or a placebo supplementation group and they will consume 1500 mg/day of Sideritis or placebo, distributed in three equal doses (every 8 hours) for one month. At baseline and post-intervention, volunteers will be assessed for their anthropometric profile, muscle function and cardiorespiratory capacity and will provide a resting blood sample for the assessment of oxidative stress and health biomarkers. Participants will be asked to record their diet for 3 days prior to the study and they will be asked to follow the same dietary pattern for 3 days before the post-intervention assessments.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Individuals aged 18-65 years

Exclusion Criteria:

* Musculoskeletal injury
* Dietary supplements
* Medication
Safety and Tolerability of MA09-hRPE Cells in Patients With Stargardt's Macular Dystrophy(SMD)

The purpose of this study is to evaluate the safety and tolerability of RPE cellular therapy in patients with SMD

* to evaluate the safety and tolerability of RPE cellular therapy in patients with SMD
* to evaluate the preliminary efficacy of MA09-hPRE in patients with SMD

Eligibility Criteria:
Inclusion Criteria:

* Adult male or female over 20 years of age.
* Clinical diagnosis of advanced SMD.
* The visual acuity of the eye to receive the transplant will be no better than hand movement.
* The visual acuity of the eye that is not to receive the transplant will be no better than 24 (20/320) Early Treatment of Diabetic Retinopathy Study (ETDRS) letters.

Exclusion Criteria:

* History of malignancy.
* History of myocardial infarction in previous 12 months.
* History of diabetes mellitus.
* Any immunodeficiency.
* Any current immunosuppressive therapy other than intermittent or low dose cortico steroids.
* Serologic evidence of infection with Hepatitis B, Hepatitis C, or HIV.
* Current participation in any other clinical trial.
* Participation within previous 6 months in any clinical trial of a drug by ocular or systemic administration.
* Any other sight-threatening ocular disease.
* Any chronic ocular medications. Any history of retinal vascular disease (compromised blood-retinal barrier). Glaucoma. Uveitis or other intraocular inflammatory disease. Significant lens opacities or other media opacity. Ocular lens removal within previous 3 months
Studies of Patients With Skin Disease, Patients With Neurological Degenerations, and Normal Volunteers

It is proposed that patients with skin disease due to presumed immunologic, genetic or viral-induced abnormalities, patients with neurological degenerations, and normal controls be evaluated with various in vitro studies of immunologic, genetic, and virologic function. This is to include studies of peripheral blood (cells and serum) as well as studies of skin obtained with a biopsy instrument. In addition, studies of gastrointestinal function will be performed where appropriate.

It is proposed that patients with skin disease due to presumed immunologic, genetic or viral-induced abnormalities, patients with neurological degenerations, and normal controls be evaluated with various in vitro studies of immunologic, genetic, and virologic function. This is to include studies of peripheral blood (cells and serum) as well as studies of skin obtained with a biopsy instrument. In addition, studies of gastrointestinal function will be performed where appropriate.

Eligibility Criteria:
Patients with skin diseases of presumed genetic, immunologic, or virologic origin are eligible.

Patients with neurological degenerations are eligible, including patients with inflammatory, neoplastic and viral skin diseases and also heterozygous carriers of such inherited diseases.

Volunteers without skin diseases are eligible, except children.
Clinical Investigation of NMS Assist

Parkinson's can cause a wide range of non-motor symptoms (NMS), including pain and problems with mental health, memory and sleep. These affect the quality of life of people with Parkinson's (PwP) and their care partners (CP). If these issues are not recognised and managed quickly, they can result in escalating problems. Many PwP are unsure of the extent and variety of the NMS and how simple adjustments at home could improve them. We have developed a digital system, NMS Assist, to help PwP monitor their non-motor symptoms and develop skills to self-manage them.

Such a tool needs to be simple to use, safe and effective. We will ask 60 PwP, CP and members of their Parkinson's healthcare team to use NMS Assist for 12 months, and we will monitor how they use the tool. PwP and CPs will be asked if they feel more knowledgeable and confident to manage their own symptoms whilst being better able to discuss a problem with their healthcare professional.

A smaller group of the participants will discuss their experiences in more detail to help pinpoint aspects that work well and those needing adjustment and development. Members of the healthcare team will be asked to assess any improvement in communication with PwP and CPs.

It is thought that the use of this system will result in improved quality of life and increased knowledge and confidence for managing symptoms while safely reducing the time spent by health care professionals on manageable non-motor symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide informed consent and comply with intervention requirements
* 18 years or older
* Be fluent in English
* Not resident in a care or nursing home
* Ambulant
* Have compatible smartphone/data access
* Normally under the care of the Parkinson's service in the participating organisation
* Participant's HCP in the participating organisation consented to participate in the study

Exclusion Criteria:

* Secondary cause of parkinsonism
* Significant cognitive impairment or a diagnosis of Parkinson's disease dementia
* Living in residential care facilities
* Previous involvement in development or testing of the NMS Assist system
* Significant comorbidity, which in the opinion of the chief investigator would preclude safe participation in the study or protocol compliance (e.g. life expectancy \<6 months)
* In a dependent/unequal relationship with anyone involved in the research or care teams
The Application of Bovine Basic Fibroblast Growth Factor Gel in the Treatment of Sensitive Skin

The Application of Bovine Basic Fibroblast Growth Factor Gel in the Treatment of Sensitive Skin


Eligibility Criteria:
Inclusion Criteria:

1. Sensitive skin with a diagnosis of persistent erythema and a lactate irritation test score of 2-3
2. No related skin care products including bovine alkaline fibroblast growth factor were used within 1 month before participating in the experiment, and photoelectric treatment measures were not carried out
3. Physical sunscreen should be strict during enrollment

Exclusion Criteria:

1. Children
2. Have serious heart, liver, kidney, and blood system diseases, and severe immunocompromise
3. Patients with mental illness or cancer
4. Those who have received glucocorticoids, calcineurin inhibitors, topical small molecule drugs, antibiotics or tretinoin within 3 months
5. Those who are allergic to basic fibroblast growth factor gel and its components
6. Acute dermatitis of the face and perifolliculitis
Medication Incidents in Primary Care Medicine

Prospective reporting of safety incidents concerning drug treatment by approximately 120 primary care physicians or pediatricians during 2015.

Objectives: Patient safety is a major concern in healthcare systems worldwide. Although most safety research has been conducted in the inpatient setting, evidence indicates that medical errors and adverse events pose a serious threat for patients in the primary care setting as well, since most patients receive ambulatory care. Information about frequency and outcomes of safety incidents in primary care is required to identify risks or "hot spots," to prioritize them and to take the action as needed.

Methods:

Participants: Patients undergoing drug treatment by approximately 120 primary care physicians or pediatricians reporting to the Sentinel system.

Collection of data: Questionnaires for cases, for clinical denominator data, and for physician practice specification.

Study intervention: none.

Primary outcome:

● To describe the type, frequency, seasonal and regional distribution of medication incidents

Secondary outcomes:

● To elucidate risk factors like age, gender, poly-medication, morbidity, foreign care, hospitalization.

Statistics: Descriptive statistics, logistic regression. Estimated sample size: 500.

Flow chart: January 2015: Baseline physicians questionnaire. May 2015: Denominator data collection during 14 d. December 2015: Final physicians questionnaire. January to December 2015: Collection of case questionnaires / Counting of daily patient-to-physician contacts. After December 2015: Statistical Evaluation of data, publication.

Eligibility Criteria:
Inclusion Criteria:

* Any erroneous event (as defined by the physician) related to the medication process interfering with normal treatment course

Exclusion Criteria:

* Lacking treatment effect, adverse drug reactions or drug-drug or drug-disease interactions, without detectable treatment error.
* Refusal of patients to refer data to the Sentinel system.
The Effectiveness of "CARE Coaching Model" as an Effort to Empower Type 2 Diabetes Mellitus Patients

In Indonesia and others countries, only 30.8% patients with type 2 diabetes mellitus (T2DM) achieved glycemic control with HbA1c \<7%. Optimal pharmacological treatment alone does not guarantee an optimal outcome, therefore it should be combined with lifestyle management. Health coaching helps T2DM patients increase self awareness to improve and maintain behavior which play a role in self-management. This study aims to evaluate the impact of health coaching on glycemic control on T2DM patients.

Subjects randomized into 2 groups: control and intervention group. All subject received education class in top of standard treatment. Intervention group received additional personal health coaching.

Education and health coaching was given for 12 sessions every 2 weeks with 12 different themes for each session. Health coaching were given by International certified health coach.

Laboratory examination and questionnaire collected at baseline, 3 and 6 months after intervention.

Eligibility Criteria:
Inclusion Criteria:

* T2DM patients
* aged 30-60 years old
* HbA1C \> 7.5% within the past 3 months
* able to write and read.

Exclusion Criteria:

* Patients with cognitive disease (such as dementia)
* having hearing problem or sight problem
* unable to live independently on daily basis
* having disease that may affect HbA1c result (eg: hemolytic anemia)
A Study of the Safety and Efficacy of a New Treatment for Non-Infectious Anterior Uveitis

This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of non-infectious anterior uveitis.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older with a diagnosis of non-infectious anterior uveitis in at least one eye

Exclusion Criteria:

* Uncontrolled systemic disease
* Any active ocular infections
Phase III Study of ICI35,868 (Diprivan) With and Without EES0000645/A (SDS) on Gastrointestinal Endoscopy

This study is designed as a multi-centre, randomised, parallel-group, placebo-controlled, phase III confirmatory study. The study will be partially double-blinded: the comparison between Group 1 (placebo group) and Group 2 (ICI35,868 without EES0000645/A) will be carried out in double-blind, but the comparison between Group 1 (placebo group) and Group 3 (ICI35,868 with EES0000645/A) will be carried out in single-blind.

The efficacy and safety of ICI35,868 with and without EES0000645/A for the sedation to be moderate for a diagnostic gastrointestinal endoscopy and gastrointestinal endoscopic polypectomy will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

1.Provision of written informed consent prior to any study-related procedures/examinations 2.Aged 20 years and older 3.Subjects who are planned to undergo a non-emergent EGD or colonoscopy, including gastrointestinal endoscopic polypectomy that shall be completed within 1 hour (excluding the endoscopic submucosal dissection and ultrasonic endoscope, pernasal endoscope, etc.). Exclusion Criteria:

1. involvement in the planning and/or conduct of the study (applies to both sponsor's employees and/or staffs at the study site)
2. Subjects who underwent a endoscopic procedure under ICI35,868 (propofol) administration within 1 year.
3. Participation in another clinical study with an investigational product within 4 weeks prior to randomisation.
4. Baseline (Visit 1) of blood oxygen saturation (SpO2)\<90% (room air)
5. ASA III, IV, V and VI ; Subject with serious disease of cardiovascular, respiratory, renal, liver, pancreatic or endocrine function.
Efficacy and Safety of Prothromplex Total (Prothrombin Complex Concentrate) in Oral Anticoagulant Reversal

The purpose of the study is to assess the efficacy and safety of Prothromplex Total as a treatment for the immediate reversal of oral anticoagulant therapy with vitamin K antagonists in patients with acquired deficiency of prothrombin complex coagulation factors (II, VII, IX, X). Upon enrolment, subjects will receive Prothromplex Total for the treatment of acute bleeding due to oral anticoagulants or for the prevention of excessive bleeding during the interventional procedure (Day 1). Additional doses of Prothromplex Total may be administered at the discretion of the investigator. Efficacy and safety assessments will be performed during a period of 72 (± 4) hours after administration of the last dose of Prothromplex Total or until discharge from hospital, whichever occurs first.


Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 16 years or older at enrolment with acquired deficiency of prothrombin complex coagulation factors (II, VII, IX, X), due to oral anticoagulation with vitamin K antagonists (e.g. coumarin, warfarin), requiring reversal of oral anticoagulation for urgent surgery, or invasive procedure or acute bleeding episode
* Subject or parent/legally authorised representative has provided written informed consent
* Subject has INR \>= 2,0 at screening
* Subject is willing and able to comply with the requirements of the protocol

Exclusion Criteria:

* Subject has laboratory and/or clinical symptoms which are clearly indicative of overt disseminated intravascular coagulation (DIC)
* Subject has been treated with whole blood, fresh frozen plasma (FFP), or platelets within 6 hours prior to study enrolment
* Subject has a hypersensitivity to prothrombin complex concentrate (PCC) constituents (including heparin-induced thrombocytopenia)
* Subject has blood loss of \>= 5 units of blood
* Subject has hereditary thrombophilia or bleeding disorder
* Subject has a life expectancy of \< 3 months
* Subject has been on oral anticoagulant treatment for a period of \< 4 weeks for the treatment of a thrombotic event such as deep vein thrombosis or pulmonary embolism
* Subject has an acute ischemic cardiovascular disorder
* Subject has or is suspected to have sepsis
* Subject with acute or chronic liver failure (hepatic cirrhosis Child-PUGH score C)
* Subject has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrolment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study
Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 655130 in Healthy Male Volunteers

The primary objective of this trial is to investigate the safety and tolerability of BI 655130 in healthy male subjects following IV administration of multiple rising doses. The study will also explore safety and tolerability following a single IV administration.


Eligibility Criteria:
Inclusion criteria:

* Healthy male subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (BP - Blood Pressure, PR - Pulse Rate), 12-lead ECG (Electrocardiogram), and clinical laboratory tests
* Age of 18 to 50 years (incl.)
* BMI of 18.5 to 29.9 kg/m2 (incl.)
* Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

Exclusion criteria:

* Any finding in the medical examination (including BP - Blood Pressure, PR - Pulse Rate or ECG - Electrocardiogram) is deviating from normal and judged as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease judged as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts
* Further exclusion criteria apply
Proton Cranio-spinal Irradiation for Leptomeningeal Metastasis

Leptomeningeal metastasis is a rare but serious complication to cancer, with a grave prognosis. No efficient treatment exists.

Recent data suggest that craniospinal radiotherapy lead to superior survival and CNS control compared to focal photon radiotherapy. We want to offer Danish patients the new treatment, but within a protocol, as this is new data with an new treatment principle

Patients must be referred from Danish Departments of Oncology with radiotherapy service.

Patients with leptomeningeal metastasis from both solid and hematological cancers will be offered proton radiotherapy with 30 Gy in 10 fractions to the entire craniospinal axis. Patients will be followed with registration of side effects, neurology and MRI scans every 3 months until 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Metastasis to the leptomeningeal space (LM) surrounding the brain and/ or spinal cord
* Metastasis verified by MRI or CSF cytology
* Karnofsky \>=60 (requiring some help, can take care of most personal requirements)
* Adequate bone marrow function

  * Haemoglobin \> 5 mmol/l
  * Absolute neutrophil count \>1 10\^9/l
  * Platelet count \> 100 10\^9/l
* Patient consent
* Female subjects must either be of non-reproductive potential ( ≥ 60 years old, or with no menses for \>1 year without an alternative medical cause\], OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a pregnancy test within 2 weeks prior to starting treatment.
* Patient at reproductive potential must agree to practice an effective contraceptive method.

Exclusion Criteria:

* • Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances (Yang)

  * Patient with multiple, serious major neurologic deficits per physician/investigator assessment including encephalopathy
  * Patient with extensive systemic disease and without reasonable systemic treatment options
  * Patient who is unable to undergo MRI brain and spine with gadolinium contrast
  * Pregnant or lactating women.
Trampoline Exercises Children With Developmental Coordination Disorder

RCT in which 28 children with developmental coordination disorder (DCD) were enrolled and equally distributed into two groups; Participants in control group were treated with conventional physical therapy while experimental were given conventional physical therapy in addition to trampoline exercises. Assessment was at 0, 4 and 8 week using developmental coordination disorder questionnaire (DCDQ), pediatric balance scale (PBS) and peads quality of life (PQL)


Eligibility Criteria:
Inclusion Criteria:

* Children with DCD indicated using DCDQ.

Exclusion Criteria:

* No developmental coordination disorder
* declined to participate
* Progressive unstable health condition.
Expanded Access to Telisotuzumab Adizutecan

This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to telisotuzumab adizutecan prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility Criteria:
Inclusion Criteria:

- The participant must not be eligible for an telisotuzumab adizutecan clinical trial.
Diagnosis, Incidence and Consequences of PACU-Delirium

This study aims to

1. determine sensitivity and specificity of the Confusion Assessment Method for Postanesthesia Care Unit (CAM-PACU)
2. examine the effect of postanesthesia care unit delirium (PACU delirium) on the emergence of later onset postoperative delirium (POD) as well as cognitive recovery until one month postoperatively


Eligibility Criteria:
Inclusion Criteria:

* planned surgery in the near future
* surgery time at least 60min

Exclusion Criteria:

* intracranial surgery
* expected postoperative transfer to ICU and stay exceeding 24h
* length of postoperative stay in hospital below 24h
* insufficient German language skills
* current alcohol or drug misuse
* manifest mental illness