cyrilzakka/clinical-trials huggingface dataset:
Efficacy Assessment of Probiotics in Improving Sleep Indices

To determine whether PS150 (1) reduces insomnia symptoms, (2) improves sleep quality, (3) adjusts autonomic nervous system functioning, (4) reduces the severity of anxiety and depressive symptoms, and (5) adjusts microbiome and endocrine functions.

One-hundred-forty participants with self-reported insomnia (PSQI≥ 7 \& 22 \> ISI ≥ 12) aged between 20 and 60 years old are estimated to be recruited and randomly assigned to two arms, the PS150 group and the placebo group, under the double-blinded trial. Participants take one capsule of probiotics or placebo after dinner for 30 days. Study measures include polysomnography (PSG), subjective sleep, depressive, and anxiety questionnaires, sleep diary, fecal sampling, saliva testing, and urine testing.

Eligibility Criteria:
Inclusion Criteria:

1. aged 20-60 years old,
2. self-reported Insomnia (PSQI ≥ 7 \& 22 \> ISI ≥ 12),
3. 17.5 \< BMI \< 35 kg/m\^2, and
4. regular sleep cycle.

Exclusion Criteria:

1. used antibiotic, sleep aids, tranquilizers, or antipsychotic treatment within the last month,
2. used other probiotic products within the last month,
3. taking medications known to commonly induce sleep disorders (such as corticosteroids, antihistamines, and stimulants, etc.) or currently undergoing hormone therapy, including contraceptive pills,
4. have undergone hepatobiliary gastrointestinal tract surgery
5. lactic acid bacteria allergy,
6. with cancer, cardiovascular disease, psychiatric illness, or kidney disease,
7. with uncontrolled diabetes mellitus or hypertension,
8. with sleep disorders other than insomnia,
9. allergic to lactobacillus,
10. reported tobacco, alcohol, caffeine or drug addiction,
11. traveled to different time zone in long-distance trip within the last month,
12. participated in other interventional studies within the last three months, and
13. evaluated as unsuitable participant by PI.
A Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Diabetic Macular Edema and Retinal Vein Occlusion

Phase 2a multicenter, open-label, parallel-arm design study to evaluate the safety, tolerability and pharmacodynamics of a single intravitreal injection comparing 2 dose levels of GB-102 on subjects with Diabetic Macular Edema and Retinal Vein Occlusion

Phase 2a multicenter, open-label, parallel-arm design study to evaluate the safety, tolerability and pharmacodynamics of a single intravitreal injection comparing 2 dose levels (1 mg and 2 mg) of GB-102 on subjects with Diabetic Macular Edema and Retinal Vein Occlusion who have received prior treatment with anti-vascular endothelial growth factor (VEGF)

Eligibility Criteria:
Inclusion Criteria:

* Males or females ≥ 21 years of age
* Known diagnosis of macular edema secondary to diabetic macular edema or retinal vein occlusion treated with at least 3 prior IVT injections of an anti-VEGF agent (aflibercept, bevacizumab, or ranibizumab)
* Demonstrated response to prior anti-VEGF treatment since diagnosis
* BCVA of 31 letters or better

Exclusion Criteria:

* History, within 6 months prior to screening, of any of the following: myocardial infarction, any cardiac event requiring hospitalization, treatment for acute congestive heart failure, transient ischemic attack, or stroke
* Uncontrolled hypertension, diabetes mellitus or IOP
* Chronic renal disease
Treatment of GHD Associated With CHF

Aim of the current study is to assess the cardiovascular effects of GH replacement therapy in patients with coexisting GHD and CHF

Multiple anabolic deficiencies are common in chronic heart failure (CHF) and identify subgroups of patients with higher mortality. Apart from CHF, GH deficiency (GHD) per se increases cardiovascular mortality in the general population and low IGF-1 levels in the general population predict the development of ischemic heart disease and CHF. GHD modifies cardiac size and function, through a reduction in both myocardial growth and cardiac performance. The investigators therefore completed 2 studies aimed at evaluating the clinical status, neurohormonal parameters, exercise capacity, vascular reactivity, and left ventricular architecture and function in patients with GHD and CHF, at baseline and after 6 months of GH replacement therapy. They subsequently extended the observation period up to 48 months. At 6-months, GH replacement therapy improved clinical status and exercise capacity, as shown by a significant reduction of the Minnesota living with heart failure questionnaire score, increased peak oxygen consumption and exercise duration, and flow mediated vasodilation of the brachial artery. No major adverse events were reported in the patients receiving GH.

However, the encouraging results of these studies are limited by the lack of a double-blind, placebo-controlled design, insofar as the investigators performed a randomized controlled, single-blind study.

Eligibility Criteria:
Inclusion Criteria:

1. patients of either sex affected by CHF NYHA class I-III, secondary to ischemic or idiopathic di-lated cardiomyopathy;
2. age range 18-85 years;
3. stable and optimal medical therapy for at least three months prior to randomization, including ACE inhibitors or AT1 antagonists and beta-blockers (unless untolerated);
4. LV ejection fraction 40% or less and LV end-diastolic dimension 55 mm or more;
5. GH deficiency diagnosed with GHRH + arginine provocative test;
6. signed informed consent.

Exclusion Criteria:

1. inability to perform a bicycle exercise test;
2. poorly controlled diabetes mellitus (HbA1c \>8.5) and/or active proliferative or severe non-proliferative diabetic retinopathy;
3. active and/or history of malignancy;
4. unstable angina or recent myocardial infarction (less than six months);
5. severe liver or kidney disease (serum creatinine levels \>2.5 mg/dl
Nicotinamide Riboside and Prevention of Cancer Therapy Related Cardiac Dysfunction in Breast Cancer Patients

Breast cancer is the most common form of cancer in women. Modern breast cancer treatments have led to increased survival, but at the same time, increased risk for cardiotoxicity and development of heart failure. In this study, the investigators want to evaluate whether nicotinamide riboside can prevent cancer-related cardiac dysfunction in metastatic breast cancer patients scheduled for anthracycline therapy. Further, the investigators will evaluate change in signs of skeletal muscle injury and functional capacity.

The trial is prospective, randomised, double-blind and placebo-controlled. The primary objective is change in left ventricular ejection fraction (LVEF), determined by cardiac MRI (CMR). Secondary objectives are change in circulating high-sensitivity cardiac troponin I and T (hs-TnI and hs-TnT), Creatine Kinase (CK) and myoglobin, and various measurements of change in left ventricular systolic function determined by CMR and echocardiography. Additional assessments are evaluation of the patient's functional capacity and the patients will be asked to fill out questionnaires to assess quality of life.

60 patients will be randomised in a 1:1 ratio. The duration of blinded therapy will depend on the duration of anthracycline therapy. All patients will be examined at baseline and 3 months, and if the patient is scheduled for extended anthracycline therapy, an additional examination will be performed at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Women with metastatic breast cancer (stage IV breast cancer) scheduled for anthracycline-containing chemotherapy
* Eastern Cooperative Oncology Group performance status 0-2

Exclusion Criteria

* Age \<18 years
* Acute myocardial infarction within the last three months
* Participation in another pharmaceutical clinical trial of an investigational medicinal product (IMP) less than 4 weeks prior to inclusion or use of other investigational drugs within 5 half-lives of enrollment, whichever is longer
* Conditions that would affect the participants to comply with the study protocol as psychiatric or mental disorders, alcohol abuse or other substance abuse, suspected poor drug compliance, language barriers
* Life expectancy \< 6 months
* Known allergy to any of the components in the Nicotinamide Riboside (Niagen®) tablet
* Contraindications or inability to undergo CMR examination
Evaluation of Low Dose Laser in Treatment of Tinnitus

The purpose of this study is to determine wether low dose laser is effective on idiopathic subjective tinnitus.


Eligibility Criteria:
Inclusion Criteria:

* Adults older than 18 years old
* Idiopathic, subjective, unilateral tinnitus with at least 2 month duration

Exclusion Criteria:

* Patients with chronic otitis media
* Patients with tympan perforation with any underlying cause
* Patients with external otitis
* Patients with tinnitus related to a retrocochlear lesion or other known lesions of the ear
Evaluation of the Pharmacokinetics and Safety of VX-548 in Participants With Mild or Moderate Hepatic Impairment

The purpose of this study is to evaluate the pharmacokinetics and safety of multiple doses of VX-584 in participants with mild or moderate hepatic impairment as compared to matched healthy controls.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4) (A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility Criteria:
Key Inclusion Criteria:

* Cohorts 1 and 3: Participants with Mild or Moderate Hepatic Impairment

  * Participants will satisfy the criteria for mild (Cohort 1) and moderate hepatic impairment (Cohort 3) defined as a Child-Pugh total score of 5 to 6 and 7 to 9 points, respectively at the screening visit
  * Participants will have chronic (greater than or equal to (≥) 6 months) documented liver disease
* Cohorts 2 and 4: Matched Healthy Participants

  * Participants will be matched (cohort 2 matched to cohort 1; and cohort 4 matched to cohort 3) during screening to participants with hepatic impairment for age, sex, and weight

Key Exclusion Criteria:

* Cohorts 1 and 3: Participants with Mild or Moderate Hepatic Impairment

  * History of febrile illness or other acute illness that has not fully resolved by 14 days before the first dose of study drug
  * Severe portal hypertension
  * History or presence of severe hepatic encephalopathy (Grade \>2)
  * Any condition possibly affecting drug absorption
  * Significant renal dysfunction (creatinine clearance \<60 milliliter per minute \[mL/min\] ) estimated according to the method of Cockcroft and Gault at the screening Visit or Day-1
  * History of solid organ or bone marrow transplantation
* Cohorts 2 and 4: Matched Healthy Participants

  * History of febrile illness or other acute illness that has not fully resolved by 14 days before the first dose of study drug
  * Any condition possibly affecting drug absorption

Other protocol defined Inclusion/Exclusion criteria may apply.
An Investigational Immuno-therapy Trial of Pomalidomide and Low-dose Dexamethasone With or Without Elotuzumab to Treat Refractory and Relapsed and Refractory Multiple Myeloma (ELOQUENT-3)

The purpose of this study is to determine if adding Elotuzumab to Pomalidomide and low-dose dexamethasone is a more effective treatment of relapsed and refractory multiple myeloma compared to pomalidomide and low-dose dexamethasone by itself.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* ≥ 2 prior lines of therapy which must have included at least 2 consecutive cycles of lenalidomide and a proteosome inhibitor alone or in combination
* Documented refractory or relapsed and refractory multiple myeloma
* Refractory to proteosome inhibitor and lenalidomide, and to last treatment
* Relapsed and refractory patients must have achieved at least a partial response to previous treatment with proteosome inhibitor or lenalidomide, or both, but progressed within 6 months, and were refractory to their last treatment
* Measurable disease at screening
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion Criteria:

* Active plasma cell leukemia
* Prior treatment with pomalidomide
* Unable to tolerate thromboembolic prophylaxis while on the study
* Prior autologous stem cell transplant within 12 weeks
* Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C
Influence on Erythropoetin-level by Xenon

The purpose of this study is to analyze the effect of xenon-inhalation on erythropoetin-level in blood of healthy volunteers and to determine the efficient time of inhalation.

Hypothesis: Xenon-inhalation enhances erythropoetin-levels in blood

Xenon-gas is an approved anesthetic by the EMEA and is used for a balanced anesthesia in combination with opioids for adults with a american society of anesthesiology classification ASA ≤ III. Several clinical and pre-clinical studies have shown a positive effect of xenon on several organ functions such as in brain, kidneys and heart. In two studies, an enhanced expression of hypoxia inducible factor-1α (HIF-1α) could be shown in animal kidneys and kidney cells. Interestingly, HIF-1α leads to an enhanced formation of erythropoetin (EPO). This might result in an enhanced oxygen transport capacity and an enhanced oxygen-level after xenon-treatment.

Aim of the project is to analyze the effect of xenon-inhalation on circulating erythropoetin-level in blood of healthy volunteers in a randomized controlled pilot study. Besides, other positive stimulating factors for erythropoiesis (such as HIFa stabilizing factors) and growth factors (such as fibroblast growth factors (FGFs), hepatocyte growth factor (HGF), mechano growth factors (MGFs), platelet-derived growth factors (PDGFs), vascular endothelial growth factors (VEGFs)) shall be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Male subjects
* Age: \> 18 years
* legally competent to sign
* without any known medical condition or medication prescribed at the University Hospital RWTH Aachen, Germany
* Persons that are able and willing to understand and follow the instructions of the study personnel
* Signed informed consent

Exclusion Criteria:

* Smoker, alcoholic or person who regularly consumes drugs or medication
* Persons with a medical condition that is contraindicated with the planned treatment
* Known hypersensitivity against xenon
* Persons not legally competent to sign
* Simultaneous participation at any other trial
* Blood-loss due to trauma during the period of the study or 2 months previous
* Blood donation during the period of the study or 2 months previous
Advanced Telemonitoring of Patients With COPD in Home Environment

Chronic obstructive pulmonary disease (COPD) is one of the leading and rising causes of morbidity and mortality worldwide. The most important etiopathogenetic agent is smoking. However, air-pollution probably also plays a crucial role in the disease development, progression and exacerbations. The multimodal-telemedicine approach may provide a useful tool in the patient follow-up with the aim to reduce disease exacerbation rate and improve the health-related quality of life. The study aims to investigate the effects and utility of advanced telemonitoring in elderly COPD patients. All data will be integrated in a single web-based platform in order to analyse the mutual effects of different conditions and variables.


Eligibility Criteria:
Inclusion Criteria:

* COPD
* ≥ 60 years of age
* Informed written and verbal consent
* Ability to participate in study activities

Exclusion Criteria:

* Active smoking
* Respiratory failure requiring oxygenotherapy or ventilation support
* Severe psychological disturbances
* Absence of collaboration (informed consent)
* Other comorbid pulmonary disease
* Symptomatic heart failure
* Motor neuron diseases (e.g. amyotrophic lateral sclerosis etc.)
The Effect of Whey Protein and Dietary Fibers on Risk Markers of the Metabolic Syndrome and Bone Health

The prevalence of overweight and lifestyle related diseases such as cardiovascular disease (CVD) and type 2 diabetes (T2D) is increasing world wide. The metabolic syndrome (MeS) is a condition characterized by abdominal obesity, high blood lipids, high blood pressure and elevated blood sugar. MeS is associated with an increased risk of developing CVD and T2D. Dietary fibers and whey protein have independently shown beneficial effects on several of these risk factors in previous studies. Whey protein is furthermore seen to show positive effects on bone turnover.

The purpose of this trial is to investigate whether an increased intake of dietary fibers and whey protein (separately or combined) over a period of 12 weeks will affect the risk markers of MeS and bone turnover in abdominally obese subjects.

A total of 80 people with abdominal obesity will be included. The design is a randomized, double blinded, controlled dietary intervention trial. Subjects are assigned to one of four experimental groups. Each group are provided with test products containing either high or low whey protein and high or low dietary fibers to replace part of their regular diet. The subjects are instructed in how to incorporate the test products in their habitual diets in order to maintain weight stability.

The primary outcome is postprandial lipaemia (PPL) - an independent risk factor of developing CVD. PPL is estimated by performing a standardized high fat meal test during which postprandial level of triglycerides is measured. The authors hypothesize that a diet of high content of whey protein and high dietary fiber during 12 weeks will induce a reduction in PPL.

Please refer to summary

Eligibility Criteria:
Inclusion Criteria:

* Waist circumference ≥ 80 cm (women)/94 cm (men)
* Age ≥40 years

Exclusion Criteria:

* Significant cardiovascular, renal or endocrine disease
* History of diabetes
* ≥ 3 kg of weight gain or loss within the last 3 months
* Any change in medication within the last month
* Treatment with steroids
* Pregnancy, breastfeeding or planned pregnancy
* Psychiatric history
* Alcohol or drug addiction
* Dietary fiber supplement within the last month
Glucometer and Mobile-phone Based Data Transfer System in Diabetes

To determine if glucometer combined with mobile-phone based data transfer system would be useful for patient diabetes to manage their glycemic control.

Patients with diabetes who are advised by their providers to self-monitoring of blood glucose are eligible. Patients who decline or are not able to do self-monitoring of blood glucose will serve as controls.

Eligibility Criteria:
Inclusion Criteria:

1. Patient with diabetes
2. Patients' providers advised self-monitor of blood glucose
3. Provided written informed consent.

Exclusion Criteria:

1. Patients had other medical condition that were considered not eligible by the medical team members
CPCT-05 Biopsy Protocol Patient Selection

Our knowledge on the genetic mutations in cancer is rapidly expanding and we are increasingly testing drugs in mainly metastatic cancer patient populations with rare mutations. Successful examples of this new strategy are ALK inhibitors in ALK translocated NSCLC (less than 5% frequency) and EGFR inhibitors in EGFR mutant NSCLC (approximately 5% frequency). Selecting molecularly stratified patient populations for studies benefits the patient as it increases the odds of obtaining benefit from experimental treatment, especially in early clinical trials. Moreover it increases the speed and efficacy of drug development as signs of efficacy are picked up in earlier phases. Therefore, broad screening of molecular lesions in the tumors of patients that are being considered for participation in trials is crucial. This pre-selection increases our ability to perform several trials in parallel and thus include more patients in more meaningful trials. With the still dismal prognosis of patients with metastatic cancer, increasing the accrual rate to pivotal trials in selected patient populations is a key factor in improving prognosis.

The advent of Next Generation Sequencing (NGS) platforms enables us to probe a limited number of cancer related genes within 2-4 weeks. We have extensively piloted this approach and are now able to deliver clinically meaningful turn-around-times. This development enables us to use this technology to enrich clinical trials using targeted therapies for patients with specific mutations.

We will obtain tumor biopsies of a metastatic or locally advanced lesion and a peripheral blood sample from all patients included in the trial; the biopsies to obtain information on the tumor related genetic mutations (mutational profile) and the blood samples to assess each patient's germline DNA background variation. As patients will be asked to undergo an invasive procedure it is important to address the potential safety issues. Review of the literature and our own experience show that tumor biopsies can be performed with only minor complications and acceptable risks. We will recruit patients with metastatic or locally advanced solid tumors from patients that can potentially be included in clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced (incurable) or metastatic cancer from a histological or cytological proven solid tumor
* Indication for systemic treatment with anti-cancer agents (with no treatment options with curative intent)
* Measurable locally advanced (incurable) or metastatic lesion(s), according to RECIST 1.1 criteria.
* Safe biopsy of a metastatic or locally advanced lesion possible
* No contraindications for lidocaine (or its derivatives) and/or midazolam and/or phentanyl
* Adequate organ function
* WHO performance status 0-2
* Age \> 18 yr
* Expected adequacy to follow up
* Written informed consent

Exclusion Criteria:

• If one or more of the above mentioned inclusion criteria is not met
Topera E-FIRM Registry

This is a registry to assess the safety and effectiveness of FIRM guided procedures for the treatment of symptomatic any type of atrial fibrillation.

FIRM (Focal Impulse and Rotor Modulation) guided ablation is defined as ablating rotors identified by the FIRMap® basket catheter for visualising of rotors with the RhythmView® mapping system. In addition to the FIRM guided ablation any other ablation method could be applied.The acute success of FIRM ablations is defined as elimination of rotors defined by absence of rotors.

Data items will be collected, if available, consistent and applicable with routine and standard clinical care at each participating site.

Prospective and retrospective enrollment is possible.

Eligibility Criteria:
Inclusion Criteria:

reported incidence of at least 2 documented episodes of symptomatic AF (paroxysmal, persistent or long standing persistent) during the 3 months preceding the initial AF ablation attempt of at least one Class I or III anti-arrhythmia drug with failure defined as recurrence of symptomatic AF or adverse drug effect resulting in stopping medication

Exclusion Criteria:

women who are pregnant

As this is a registry only data of patients will be included who have been treated according to the current AF guidelines.