cyrilzakka/clinical-trials huggingface dataset:
Effect of Type 1 Diabetes on Sleep Fragmentation

The main objective of this study is the objective evaluation of disease related sleep fragmentation in subjects with type 1 diabetes.

The influence of sleep duration and sleep schedules (social jetlag) on glycemic control in type 1 diabetes has been shown in several previous studies, including by the investigators of this study.

Following these publications, patients have expressed the opinion via social networks that type 1 diabetes disease is itself a factor that alters the quality of sleep. Indeed, it appears that the cross-sectional studies published to date have focused on the association between the subjects' sleep habits and the balance of their diabetes, without having questioned the role of the pathology on sleep quality.

The main objective of this study is the objective evaluation of disease related sleep fragmentation in subjects with type 1 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Self-reported type 1 diabetes
* Male or female
* Self-reported age \> 18 years old
* Subject user of a freestyle capillary meter

Exclusion Criteria:

* Opposition to Use of Data for Teaching and Research Purposes
* Other type of diabetes
* Self-reported age under 18 years of age
* Subject non-user of a freestyle capillary meter
Mental Health Care Provision for Adults With Intellectual Disability and a Mental Disorder

Quality of mental health services provision for adults with intellectual disability and comorbid mental disorder is considered inadequate and therefore in need of further improvement. However, empirical findings on this topic are rather scarce. The MEMENTA-study therefore aims to compare mild and moderate intellectual disabled adults with a comorbid mental disorder to mild and moderate intellectual disabled adults who do not have a comorbid mental disorder with respect to clinical parameters. The MEMENTA-study is an observational, epidemiological, cross-sectional study. A representative sample of the target population is realised by the assessment of approximately n=600 intellectual disabled adults working at specialized facilities (sheltered workshops). A cluster sampling with probability proportional to institution and size (n of overall employed persons) will be followed by a simple random sampling of persons of these clustered facilities. A number of parameters such as severity of mental health impairment, needs for care, quality of life (QoL), caregiver burden, health services utilization, and costs for care will be assessed by using a set of well-established standardised instruments. Quality of mental health care will be assessed and examined by open questions to intellectual disabled adults with a comorbid mental disorder as well as informal caregivers and staff of caring institutions.


Eligibility Criteria:
Inclusion Criteria:

* mild or moderate intellectual disability
* adults aged between 18-65 years
Endoesophageal Brachytherapy for Patients With Esophageal Cancer

Depending upon the cancer stage, esophageal cancer can be treated with surgery, chemotherapy, radiation therapy, or a combination of these modalities. Sometimes in addition to external radiation therapy or instead of external radiation therapy, select patients with esophageal cancer may benefit from localized radiation to the tumor, called esophageal brachytherapy. There are many different radiation techniques and delivery approaches for this type of specialized radiation therapy, and the purpose of this document is to provide a written summary of an innovative delivery method.

Primary Objective Pilot study of multichannel endoesophageal brachytherapy applicator to determine dose distribution and conformality of a 6 channel balloon repositioning applicator.

Secondary Objective(s)

1. To collect data in order to show how the 6-tube endoesophageal brachytherapy technique will be an improvement (more conformed dose distribution) over a previously designed 3-tube endoesophageal brachytherapy technique in patients who are candidates for esophageal brachytherapy
2. To evaluate acute toxicity of novel endoesophageal brachytherapy applicator.

Study Design

This innovative study will be an improvement over a previously designed 3-tube endoesophageal brachytherapy technique in patients who are candidates for esophageal brachytherapy. The brachytherapy planning process will utilize a novel multichannel balloon applicator.

The initial treatment session will occur after the patient has been found to be eligible, the consent form has been completed, and the treatment plan has been created. The patient will undergo subsequent weekly treatments for 3 to 6 weeks after the initial treatment.

The subject will be expected to participate in the trial throughout its entirety. The participation period is 6 months of which the patient will be evaluated and seen at months 3 and 6.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proved esophageal adenocarcinoma or squamous cell carcinoma
* Disease that can be encompassed in the radiotherapy treatment field
* Women of childbearing potential must practice adequate contraception
* Subjects must have the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Concurrent chemotherapy at the time of brachytherapy treatments
* Tracheal or bronchial involvement
* Cervical esophagus location
* Stenosis that cannot be bypassed or dilated to allow for applicator placement
* Not willing or unable to provide informed consent
* History of esophageal fistula
Platelet Reactivity With Fentanyl, Morphine, or no Narcotic

The goal is to determine whether fentanyl and morphine have similar effects in reducing aspirin's effect upon platelets in emergency department patients with chest discomfort. Morphine has been shown to worsen outcomes in heart attack patients due to reduction of oral anti-platelet agent effectiveness and so many providers have switches to using fentanyl. However, it is largely unknown whether fentanyl has similar effects.

Patients presenting to the emergency department with chest discomfort who are being administered aspirin will be offered enrollment in this study. At the time of their zero and two hour troponin we will also draw platelet aggregration studies to determine the effects of aspirin upon platelets. Narcotic medicines slow the absorption of aspirin. Morphine has therefore been shown to decrease the effectiveness of aspirin. Many providers therefore use fentanyl instead, however little is known about the effects of fentanyl upon aspirin. We will therefore compare the platelet reactivity of patients receiving morphine, fentanyl, or no narcotics

Eligibility Criteria:
Inclusion Criteria:

* Adult Emergency Department patients undergoing 0 and 2 hour troponin testing
* administered aspirin within 30 minutes of the initial blood draw.
* patient presented via private vehicle
* provide informed consent
* over the age of 18

Exclusion Criteria:

* Patients not expected to get a 2 hour troponin;
* patients already on aspirin, clopidogrel, or stronger anti-coagulants;
* patients who arrived via EMS (Emergency Medical Services) given it can be difficult to find the run reports to determine whether patient received fentanyl in the pre-hospital period;
* pregnant patients;
* patients on chronic narcotics;
* patients already once enrolled in this study,
* inability to provide consent in English
To Evaluate The Relationship Between Plasma Drug Levels And Receptor Binding in Lung Using PET (Positron Emission Tomography) In Healthy Volunteers

The purpose of this study is to assess the safety and tolerability of a novel positron emission tomography (PET) tracer \[11C\]BMT-136088 in healthy adult subjects for measurement of availability of Lysophosphatidic Acid (LPA1) receptors in the human lung and to use this tracer to assess LPA1 receptor occupancy using \[11C\]BMT-136088 in the human lung following oral administration of Bristol Myers Squibb (BMS)-986020.

End point Classification: Pharmacokinetics/Pharmacodynamics

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

Inclusion Criteria:

* Body weight at least 50kg (110lbs), Body Mass Index (BMI) within 19 to 32 kg/m2, inclusive
* Must be in good health as determined by medical history, physical examination, ECG, serum/urine biochemistry, hematology, and serology tests
* Negative hepatitis panel and negative human immunodeficiency virus (HIV)antibody screens

Exclusion Criteria:

* Any history or presence of clinically significant respiratory, Gastro Intestinal (GI), renal, hepatic, pancreatic, hematological, neurological (including history of seizure), cardiovascular, psychiatric (including known addictive disorders), musculoskeletal, genitourinary, immunological, or dermatological disorders, including all cancers
* Any acute or chronic condition that, in the opinion of the investigator in consultation with the BMS Medical Monitor, could jeopardize the subject's safety, tolerability, or pharmacokinetics of the BMS-986020
* Any major surgery within 4 weeks of study drug administration
* Existence of a cold, upper respiratory tract infection, or fever within 5 days prior to check-in
* Presence or history of any abnormality or illness that may affect absorption, distribution, metabolism or elimination of the study drug
* Donation of blood or plasma (exclude the screening visit) within 2 months prior to check in through end of synthesis (EOS), inclusive
Effect of Physical Exercise on Tumor Proliferation of Luminal B Breast Cancer Patients

Observational study to evaluate the effect of physical exercise prior to surgery and adjuvant systemic treatment in women with newly diagnosed operable hormone receptor(HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancers

Effect of exercise on tumor aggressiveness and the impact on patients' quality of life.

Exercise is a safe and effective treatment for women diagnosed with breast cancer (BC), that has an integral benefit during and after treatments, however, the effect at the tumour microenvironment it is unknown; previous studies have evaluated the association between exercise and BC, finding a positive influence on it, which suggest that exercise could reduce the aggressiveness of the tumour. This study will explore the exercise impact in tumor microenvironment, as part of the therapy given to the patients prior to surgery and treatment. In addition, different serum biomarkers involved and the tailoring of exercise for these women will be evaluated. The effect of exercise on treatments secondary effects, biomarkers and quality of life will be evaluated after 6 months of BC surgery. This project will open a window of opportunity to explore new translational research as well as new treatment vias to the patients of this breast cancer subgroup.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed, previously untreated clinical stage I-IIIA without previous treatment.
* ER positive breast cancer according to local results. (RH+ is defined as ≥ 1% assessed by Immunohistochemistry (IHC) to Estrogen Receptor (ER) and/or Progesterone Receptor (P)E).
* HER2 negative in the primary tumour according to local results. (HER2 confirmation should be done following the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) 2013 guidelines)
* Scheduled to undergo surgical resection.
* Ki67 levels must be over 13%, according to local results.
* At least 14 days from enrolment to planned surgical resection.
* Karnofsky performance status of at least 70% at study entry or 0-1 level in Eastern Cooperative Oncology Group (ECOG) Scale.
* Signed consent prior to initiation of study-related procedures.

Exclusion Criteria:

* Schedule to receive any form of induction/neoadjuvant therapy
* Significant cardiac disease (ventricular ejection fraction of \<50%, unstable angina, placement of cardiac stents and myocardial infarction within precious 6 months)
* Any pulmonary dysfunction which may affect to the exercise program perform.
* Any mental disease or condition that compromise the physical, psychological and emotional patients' wellness or affect to the process.
* Contraindications to a cardiopulmonary exercise test as recommended by the American Thoracic Society.
Safety/Efficacy of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Crying & Laughing) in Patients With ALS

The purpose of this study is to compare and evaluate the safety of AVP-923 (dextromethorphan/quinidine) for the treatment of emotional lability in ALS patients.


Eligibility Criteria:
Inclusion:

* 18 to 80 years of age, inclusive
* Confirmed diagnosis of ALS or probable ALS
* Clinical history of pseudobulbar affect
* If female, must not be pregnant, breast-feeding, or planning a pregnancy during the course of the study, and must have a negative urine pregnancy test prior to start of study
* If female, must have been practicing an established method of birth control for at least the prior month (oral contraceptive tablets, hormonal implant device, intrauterine device, diaphragm and contraceptive cream or foam, condom with spermicide, tubal ligation, or abstinence) or be surgically sterile or post-menopausal
* Must be willing to not take any prohibited medications during participation in the study

Exclusion:

* Known sensitivity to quinidine or opiate drugs (codeine, etc.)
* On any anti-depressive medication
* Recently (within two months) diagnosed with ALS
* Currently participating in, or who within the past 30 days have participated in, the study of another investigational new drug
* Previously received treatment with co-administration of dextromethorphan and quinidine
* History of substance abuse within the past two years
* Women who are pregnant or likely to become pregnant during the course of the study
Comparison of Combigan Two Times Daily (BID) Versus Simbrinza Three Times Daily (TID)

To compare Combigan Two Times Daily (BID) vs Simbrinza Three Times Daily (TID) in subjects currently being treated with Latanoprost for Open-Angle Glaucoma or Ocular Hypertension. Both of these drugs are currently FDA approved as combination therapy for patients with Open-Angle Glaucoma or Ocular Hypertension. The purpose of this clinical trial would be to assess which treatment, if either, is superior in lowering intraocular pressure (IOP). A secondary objective is to assess the tolerability of each drug.


Eligibility Criteria:
Inclusion Criteria:

* Open-angle glaucoma or ocular Hypertension
* Currently treated with Latanoprost for min of 6 weeks
* Male or Female 18 yrs and older
* Best Corrected Visual Acuity 20/100 or better in both eyes
* Pachymetry \>470 and \< 640
* Women of childbearing potential must have a negative urine pregnancy test at the screening/baseline visit
* Patient willing and capable of providing informed consent

Exclusion Criteria:

* C/D \> 0.8
* Visual field loss, which in the opinion of the investigator is functionally significant
* Current use of ocular steroids
* Concurrent significant active ocular disease History (within 3 months prior to Screening) of ocular laser, intraocular, filtering or refractive surgery or planned ocular surgery of any kind during study participation
* Change within prior 30 days or anticipated change in any systemic medication that is known to affect IOP
* Uncontrolled systemic disease
* Significant ocular hyperemia at baseline
* Prior glaucoma procedure within 3 months
* Females who are pregnant, nursing, or planning a pregnancy or who are of childbearing potential and not using a reliable method of contraception
* Known allergy or sensitivity to any study medication
* Asthma or any other known medical condition that the investigator feels would put patient at increased risk from any of the study medications
* Current enrollment in an investigational drug or device study or participation in such a study within 30 days prior to Screening
Phase 2 Trial of TD 6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI)

Serious infections caused by resistant bacteria are becoming more of a medical problem throughout the world. One of the ways to deal with this problem is to develop new drugs that can control these bacteria. This study will measure how well TD-6424 (Telavancin) can control infections and whether this drug can be safely given to patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have a diagnosis of one of the following complicated skin and skin structure infections with either a suspected or confirmed Gram positive organism as the major cause of the infection:

  * major abscess requiring surgical incision and drainage
  * infected burn (see exclusion criteria for important qualifications)
  * deep/extensive cellulitis
  * infected ulcer (see exclusion criteria for important qualifications)
  * wound infections
* Patients must be expected to require at least 4 days of intravenous antibiotic treatment

Exclusion Criteria:

* Previous systemic antibacterial therapy (with the exception of aztreonam and metronidazole) for \> 24 hours within 7 days prior to the first dose of study medication unless the pathogen was resistant to prior treatment or the patient was a treatment failure (no clinical improvement after 3 days).
* Burns involving \> 20% of body surface area or third degree/full thickness in nature, diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fasciitis, gas gangrene, or mediastinitis.
Different Endurance Training Protocols in Cardiac Patients

It is the aim of our study to compare the effects of 6 and/or 2 years of either HIT (carried out at correctly assessed 85-95% of maximal heart rate), pyramid, or continuous endurance training, on changes of physical exercise capacity in cardiac patients.

The three exercise arms (isocaloric) are composed as follows:

Endurance training: 31 min at 65-75% HRmax, making it a total of 25min; HIT: 4x4min intervals at 85-95% HRmax divided by 3x3min of active recovery at 60-70% HRmax, making it a total of 25 min; Pyramid: One pyramid consists of 8 one-minute blocks. Those are grouped starting with one block of 70-75% HRmax, followed by one block at 75-80% HRmax and another one at 80-85% HRmax. The top of the pyramid are 2 blocks of 85-90% HRmax. Intensity is lowered afterwards with one block of 80-85% HRmax, followed by one block at 75-80% HRmax and last one at 70-75% HRmax. Two more pyramids follow, each divided by 2min of active recovery at 65-70% HRmax, making it a total of 28min.

All protocols are initiated by 5min of warm-up and end with 5min of cool-down, both at 60-70% HRmax.

Primary Outcome: Individual maximum power output in watt (Pmax). Secondary Outcome: Change of power output in watt at lactate tresholds at 2 and 4mmol/l.

Eligibility Criteria:
Inclusion Criteria:

* acute coronary syndrome (STEMI - NONSTEMI)
* aortocoronary bypass surgery
* percutaneous coronary intervention (PCI)
* state after stable coronary heart disease
* state after heart surgeries
* state after myo-, endo-, or pericarditis
* state after heart- or lung-transplantation
* state after heart failure
* state after pulmonary hypertension
* state after peripheral venous disease
* state after electrophysiological surgery
* state after implantation of an implantable cardioverter or difibrillator
* Patients at high risk
* Patients with cardiac dysrhythmias or sudden death

Exclusion Criteria:

* unstable angina pectoris
* Heart failure (NYHA IV)
* acute myo-, endo-, or pericarditis or other infections
* pulmonary-arterial embolism or phlebothrombosis within 6 months
* hemodynamic instable dysrhythmias
* hypertrophic cardiomyopathy
* medical conditions which prevent patients from complying with the exercise program
Effect of Hyperbaric Oxygen on Functional Connectivity in Patients With Cerebral Small Vessel Disease

Patients will have a Functional MRI before and after 10 hyperbaric Oxygen treatments.

Functional MRI studies will be done before and 4-6 weeks after Hyperbaric Oxygen treatment to assess changes in connectivity of resting state neural networks. 10 hyperbaric treatments at 2 atmospheres absolute for 1 hour at pressure will be administered. A review of symptoms and and thorough clinical neurological examination by an experienced neurologist familiar with these studies will be done before and 4-6 weeks after the hyperbaric treatments.

Eligibility Criteria:
Inclusion Criteria:

* White Matter Hyperintensities on MRI
* 2 or more neurological symptoms or impairments e.g. gait disturbances, disequilibrium, cognitive decline, dysmetria, hyper-rflexia

Exclusion Criteria:

* Contraindication to hyperbaric oxygen treatment e.g. pulmonary emphysema, seizure disorder
* major eustachian tube dysfunction
* stroke with previous 6 months
* extreme cognitive impairment
* major depression
* history of migraine, electroshock therapy, brain irradiation, brain tumor, head trauma
* other uncontrolled co-morbidities, e.g. diabetes, renal or hepatic dysfunction, hypertension, thyroid disorders, carotid artery stenosis (\>70%)