cyrilzakka/clinical-trials huggingface dataset:
Home Air Purification for Eosinophilic COPD

This study evaluates the influence of home air purification on the lung health of adults with eosinophilic COPD. Half of the participants will receive real air purifiers (HEPA filters) and half will receive sham air purifiers.

Chronic obstructive pulmonary disease (COPD) is the third most common cause of death in the United States, and is exacerbated by exposure to air pollution. Knowledge about whether air purification affects the health of those with eosinophilic COPD (approximately 40% of all COPD patients seeking care), who generally have more active airway inflammation. If found to be beneficial, home air purification may offer a non-pharmacologic intervention for a large proportion of people with this common and serious disease.

This study will evaluate whether home air purification affects lung function, respiratory symptoms, nasal biomarkers (inflammatory proteins and metals) among people with eosinophilic COPD. Participants will be randomized to receive real or sham air purifier in the bedroom and living room for 12 months. The intervention group will receive two high efficiency particulate air (HEPA) air purifiers, while the control group will receive two sham air purifiers that look and sound the same as real HEPA air purifiers.

Eligibility Criteria:
Inclusion Criteria:

* Age of 40 years or more
* Physician diagnosis of COPD \[Global Initiative for Obstructive Lung Disease (GOLD) Stage II-IV disease with Forced Expiratory Volume (FEV1)/ Forced Vital Capacity (FVC) ≤70% and FEV1 (% predicted) \<80%\]
* Blood eosinophil count of \>=150 cells per μL at screening or in the previous year
* Former smoker with tobacco exposure of \>=10 pack-years

Exclusion Criteria:

* Inability to complete monthly questionnaires
* Inability to perform lung function testing
* Regularly using a portable HEPA air purifier in the home at time of enrollment
* End stage chronic disease with life expectancy \<2 years as determined by PI judgment
* Living in location other than home (e.g. long term care facility)
* Planning to change residence within the study period
Neurocognitive Outcome in Children Who Suffered From Idiopathic Increased Intracranial Hypertension (IIH)

15 patients, Ages 8-17 who were diagnosed in the recent years with Idiopathic increased intracarnial hypertension (IIH) went through a battery of neurocognitive tests to establish whether there was any affect of the disease on their cognitive function


Eligibility Criteria:
Inclusion Criteria:

* children who suffered from IIH based on history, physical examination, ophtalmological exam, LP results, Brain imagining

Exclusion Criteria:

* co morbidities
Behavioral and Pharmacological Treatment for Insomnia

This study will evaluate the long- and short-term effects of cognitive-behavior therapy (CBT), alone and in combination with zolpidem (Ambien®), for chronic insomnia.

Insomnia is a prevalent health concern which is often associated with functional impairments, reduced quality of life, and increased health-care costs. The proposed study may provide useful information about optimal models for integrating behavioral and pharmacological therapies for the clinical management of insomnia.

Participants are randomly assigned to CBT or CBT plus medication. After the 6-week acute treatment phase, participants enter into a 6-month extended treatment phase. Of those treated with CBT alone initially, responders are randomized to extended CBT or no treatment. Of those receiving the combined CBT plus medication approach initially, responders are randomized to an extended treatment consisting of either CBT plus medication (used on an as needed schedule) or CBT alone (plus medication tapering). Outcome is evaluated across measures of sleep, clinical ratings, and several indices of daytime functioning. The measures are administered at baseline, at the end of the acute and extended treatment phases, and at 6, 12, and 24-month follow-up.

Eligibility Criteria:
Inclusion criteria:

* Subjective complaint of difficulties initiating or maintaining sleep, accompanied by marked distress or daytime impairments due to insomnia
* Sleep difficulties present 3 nights or more per week and lasting for more than 6 months

Exclusion criteria:

* Major medical or psychiatric problems
Effect of Indacaterol Maleate in Chronic Obstructive Pulmonary Disease (COPD) on Lung Volume and Related Dyspnea

The purpose of this study is to determine whether indacaterol maleate 300 micrograms (mcg) is effective in the acute treatment of COPD and in particular on reducing lung hyperinflation and dynamic volumes.

Enrolled patients: COPD of any disease severity in stable conditions. 48 hours of inhalatory drugs wash out.

Evaluation: Plethysmographic test, blood gas analysis, blood pressure, cardiac frequency and Borg scale evaluation in basal condition and after 60 minutes of indacaterol maleate 300 mcg inhalation.

Eligibility Criteria:
Inclusion Criteria:

* Signature of consensus
* COPD diagnosis
* Age from 50 to 85 years old
* history of COPD at least of one year
* respiratory stable conditions at least of one month
* Any basal FEV1 expressed in % of predicted value
* FEV1/ Forced Vital Capacity (FVC) less than 70%
* Former or active smokers with at least a smoking history of 20 pack year

Exclusion Criteria:

* Pregnancy
* FEV1/FVC more than 70%
* Known deficit of alpha 1 antitrypsin
* Subjects submitted to a Lung Volume Reduction Surgery (LVRS)
* Subjects with known positivity to Human Immunodeficiency Virus (HIV)
* Misuse of alcool or drugs
* Absence of compliance in performing respiratory tests
MR Spectroscopy as a Diagnostic and Outcome Measure in Pain and SCI

The goal of this study is to compare the changes that occur in sensation and chemical properties of the brain following SCI between individuals that experience chronic pain and those that do not, and between those with SCI and the able-bodied.

This study investigates the differences in certain neurochemicals present in areas of the brain linked to pain processing in people with SCI and neuropathic pain, in people with SCI but no pain, and in able-bodied persons. We will also investigate the relationship between these concentrations of neurochemicals and different aspects of chronic neuropathic pain, including the intensity of pain, quality of life issues, sensitivity changes in areas of the body that are both painful and non-painful, and neurological status.

Eligibility Criteria:
Inclusion Criteria:

1. SCI and neuropathic pain:

   * fluent in English
   * incomplete or complete traumatic SCI
   * the injury must have occurred at least 2 years prior to entering the study
   * the injury level must be above L1 and the subjects must have evidence of preserved distal cord functions (lower extremity reflexes and bulbocavernosus or anal wink reflexes)
   * must have experienced chronic neuropathic pain at or below the level of injury for a minimum of six months
   * must have moderately severe or greater neuropathic pain
   * must be able to attend three sessions ranging from 2 to 6 hours over a period of 4 to 5 weeks
2. SCI and no neuropathic pain:

   - same as a., but participants in this group must NOT have unremitting moderate-severe pain and there will only be two sessions ranging from 2 to 6 hours over a period of 1 to 2 weeks
3. Able-bodied control subjects:

   * fluent in English
   * no history of chronic pain conditions
   * no substantial brain or body injury
   * must be able to attend two sessions ranging from 2 to 6 hours over a period of 1 to 2 weeks

Exclusion Criteria:

* current pregnancy or women who are contemplating pregnancy
* recent (one-year) history of alcohol or drug abuse
* known intra-cerebral pathology or epilepsy
* MRI findings indicative of intra-cerebral pathology
* significant post-traumatic encephalopathy from head trauma sustained at SCI or cognitive impairment indicative of traumatic brain injury
* current diagnosis of DSM-IV Axis I disorder
* inability to meet the MRI screening requirements (including, but not limited to, the presence of a pacemaker or other electronic devices, prosthesis, artificial limb or joint, shunt, some metal rods, some tattoos, or moderate to severe claustrophobia or anxiety)
A Trial Comparing Efficacy, Tolerability, and Safety of GZR101 Injection Once Daily (OD) and GZR33-70 Injection OD

This trial is conducted in China. The aim of the trial is to compare the efficacy, tolerability, and safety of GZR101 Injection and GZR33-70 Injection in type 2 diabetes inadequately controlled on basal/ premixed insulin once daily at least with or without pre-dinner meal-time insulin.


Eligibility Criteria:
Inclusion Criteria:

* 1. Signed the informed consent form (ICF) before the trial, fully understanding the trial content, process and possible adverse reactions, and being able to comply with the contraindications and restrictions specified in this protocol.
* 2.At the age of 18-75 (inclusive) at the time of informed consent, male or female.
* 3.Negative pregnancy test results for serum human chorionic gonadotropin (HCG) in women of childbearing potential at screening.
* 4.Diagnosed with type 2 diabetes mellitus above or equal to 6 months.

Exclusion Criteria:

* 1.Presence or history of malignant neoplasm prior to screening.
* 2.Known or suspected hypersensitivity to investigational medical product(s) or related products.
* 3.Severe hypoglycemia (Level 3 hypoglycemia) within 6 months prior to screening.
* 4.History of acute heart failure within 6 months prior to screening or hospitalization for coronary heart disease, myocardial infarction, unstable angina, stroke within 6 months prior to screening.
* 5. Participated in another interventional clinical study within 4 weeks prior to randomization.
Pilot Study of Imatinib Mesylate to Treat Nephrogenic Systemic Fibrosis

The purpose of this study is to determine the efficacy of imatinib mesylate in reducing cutaneous thickening and tethering in patients with nephrogenic systemic fibrosis (NSF). The study will also work to assess the safety and tolerability of imatinib mesylate in patients with chronic kidney disease and NSF.

Nephrogenic systemic fibrosis (NSF) is a recently described, extremely debilitating and painful condition that affects individuals with renal failure. Recent reports suggest an association between gadolinium exposure during magnetic resonance (MR) studies and the subsequent development of NSF in patients with chronic renal failure. NSF is characterized by rapidly progressive skin hardening, tethering and hyperpigmentation, predominantly on the extremities. Visceral involvement is rare. Skin biopsies of early NSF lesions demonstrate thickened collagen bundles, mucin deposition, angiogenesis and numerous dermal spindle cells that stain with antibodies to cluster of differentiation 34 (CD34) and procollagen. Cutaneous changes of NSF are present in up to 13% of individuals receiving hemodialysis. Among those patients with clinical evidence of NSF, the principle investigator of this protocol has recently reported that NSF is associated with increased early mortality at 24-months.

There is no proven therapy for this devastating disorder. Anecdotal reports have shown modest improvement in joint mobility and decreased skin thickening with extracorporeal photopheresis and pentoxyphylline.

Increased transforming growth factor (TGF)-beta1 messenger ribonucleic acid (mRNA) on immunostaining has been observed in skin, fascia and striated muscle. Imatinib mesylate, a tyrosine kinase inhibitor, prevents TGF-beta-induced stimulation of collagen and extracellular matrix protein synthesis as well as mRNA expression by normal fibroblasts. This observation led the principal investigator to evaluate imatinib mesylate 400 milligrams (mg) orally (p.o.) daily for 1 year in two participants with NSF. The result was significant softening of previously hardened skin with increased mobility of skin that previously had been tethered to the underlying fascia. After one month of imatinib mesylate, one of the two participants had a 20 degree reduction of his knee flexion contractures.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Biopsy-proven NSF
* Ability to give consent

Exclusion Criteria:

* Known sensitivity to imatinib mesylate or to any of its components
* Pregnant or lactating woman
* Bullous dermatologic disease
* Aspartate aminotransferase / alanine aminotransferase (AST/ALT) \>3 x upper limit of normal
* Severe congestive heart failure \[New York Heart Association (NYHA) Class III or IV\]
* Patients who have received Gleevec in the past 12 months
Combined On-demand Sildenafil Citrate and Tramadol Hydrochloride for Treatment of Premature Ejaculation

Premature Ejaculation (PE) is a common sexual dysfunction that has a negative impact on both sex partners. Several lines of treatment have been proposed for the treatment of PE i.e. psychological, behavioral, physiotherapeutic, and pharmacological therapies.Several treatment options have been proposed for treatment of PE including tramadol HCl and PDE5 inhibitors Tramadol HCl is thought to exert its therapeutic action in PE patients

It's clear that PE poses much burden not only on the patient sexual life but also on all aspects of the life of both the patient and his partner. Several treatment options have been proposed for treatment of PE including tramadol HCl and PDE5 inhibitors

. Tramadol HCl is thought to exert its therapeutic action in PE patients through one or more of the following mechanisms: weak µ-opioid effect, 5-HT2 receptor antagonist effect, N-methyl-D-aspartate receptor antagonist effect, serotonin and norepinephrine reuptake inhibitory effect , and acetylcholine receptor antagonist effect . On the other hand, PDE5 inhibitors are thought to play a therapeutic role in treating PE though the following mechanisms: peripheral delay of ejaculation through modulation of contractions of the vas deferens, seminal vesicles, prostate and urethra, increasing the duration of erection , central decrease of the sympathetic output via modulation of NO activity in the medial pre-optic area , peripheral analgesic effect, peripheral analgesic effect, increasing patient confidence, and improving the perception of ejaculation control and sexual satisfaction .

Eligibility Criteria:
Inclusion Criteria:

* no previous medical treatment for PE
* history of premature ejaculation (PE), primary or secondary, and a maximum IELT of 2 minutes prior to treatment.

Exclusion Criteria:

* drug noncompliance, positive history of diabetes mellitus, psychological problems, neurological disorders, erectile dysfunction, chronic illnesses, interpersonal troubles with the spouse, as well as long term medications that could affect the patient condition.
Milk Protein Feeding After Aerobic Exercise in Older Adults With Pre-diabetes Taking the Biguanide Metformin

The investigators propose that post-exercise milk protein feeding will enhance the mitochondrial protein synthesis (biogenesis) response to an exercise-training program. In addition, the investigators propose that this stimulatory effect of protein feeding will overcome the potential blunting effect of metformin on exercise responses. The investigators will investigate these outcomes over a 12-week exercise-training program in older adults with pre-diabetes with or without metformin treatment.

This is a randomized, placebo controlled, double blind study. 60 men and women over the age of 55 with indications of pre-diabetes will be recruited for participation and randomly assigned to one of four 12 week exercise training programs: 1)Supervised aerobic exercise 3 days per week followed by a carbohydrate drink along with daily oral administration of Metformin. 2) Supervised aerobic exercise 3 days per week followed by a protein drink along with daily oral administration of Metformin. 3) Supervised aerobic exercise 3 days per week followed by a carbohydrate drink along with daily oral administration of matching placebo. 4) Supervised aerobic exercise 3 days per week followed by a protein drink along with daily oral administration of placebo.

Daily administration of Metformin will begin as one 500 mg tablet for the first week and will increase by 500 mg/day/week until reaching 2000 mg/day by week 4 during a 12 week exercise training program. The titration dosing scheme and taking metformin/placebo with meals will help reduce the most common side effects (i.e.,gastrointestinal discomfort). If participants experience gastrointestinal discomfort, the dose will be lowered to 1500 mg/day.

Eligibility Criteria:
Inclusion Criteria:

* 55 years or older
* Individuals with Prediabetes defined as impaired fasting glucose (100 to 126 mg/dl), HbA1c (5.7-6.4%), and/or impaired glucose tolerance defined as 2 hour postprandial blood glucose of 140 to 200 mg/dl.

Exclusion Criteria:

* Medications contraindicated with Metformin (Dofetilide, Lamotrigine, Pegvisomant, Somatropin, Trimethoprim, Trospium, Gatifloxacin, Cephalexin, Cimetidine, Dalfampridine)
* Recent (less than 6 weeks) or planned imaging that requires IV contrast,
* Renal dysfunction creatinine ≥ 1.3 mg/dL in men or ≥ 1.2 mg/dL in women
* Alanine Aminotransferase (ALT) levels exceed 52 IU/L
* Heart, Kidney or Liver Disease
* Type I or Type II Diabetes
* Anti-coagulant therapy (warfarin/heparin)
* Lung/respiratory dysfunction
* Medications affecting primary outcomes
* Lactose Intolerant
* Tobacco Use
* Heavy Alcohol Use
* Cancer
* Lidocaine Allergy
A Randomized Crossover Trial of Bright Light Therapy in Irritable Bowel Syndrome

The purpose of this research study is to assess whether morning bright light therapy (BLT) using a wearable device called a Re-Timer could potentially improve Irritable Bowel Syndrome (IBS) symptoms and decrease intestinal permeability (leaky gut). Morning bright light therapy will be administrated through a safe-wearable glasses device called a Re-Timer. The Re-Timer glasses are lightweight and deliver blue-green light at 500nm, mimicking exposure to natural light.

The hypothesis of this study is that morning bright light therapy (BLT) using Re-Timer™ glasses in irritable bowel syndrome (IBS) patients with circadian misalignment (CM), will improve IBS symptom severity, improve circadian misalignment, decrease intestinal permeability and improve stool microbial diversity. Our overall objective is to assess the effects of morning bright light therapy on IBS symptom severity, circadian misalignment, intestinal permeability and intestinal microbiota. We propose to conduct a 6-week, single center, randomized, crossover pilot trial involving 30 subjects with active IBS symptoms (IBS-SSS \>75), and circadian misalignment (CM) based on late chronotype (Munich Chronotype Questionnaire, Corrected Midpoint of Sleep \> 4:00h). Subjects will be randomized to BLT or placebo with a 2-week washout between each condition. All subjects will have assessments at two timepoints: after 2 weeks of BLT, and after 2 weeks of placebo.

Eligibility Criteria:
Inclusion Criteria

* 18-65 years old
* Irritable Bowel Syndrome based on Rome IV diagnostic criteria
* Mild to severe IBS symptom severity based on IBS-SSS greater than or equal to 75 17.
* Late chronotype based on the Munich Chronotype Questionnaire (Corrected Midpoint of Sleep \> 4:00h) 18 Exclusion Criteria
* Subject that are pregnant or plan to become pregnant.
* Night shift workers or people who have crossed more than 2 time zones in the previous 4 weeks.
* Regular use of medications that affect intestinal permeability, and/or endogenous melatonin including metoclopramide, NSAIDs, beta blockers, antibiotics, psychotropic medications, hypnotics and exogenous melatonin products during 4 weeks prior to the study.
* Any major organ disease - known renal impairment, diabetes, liver disease, or significant cardiac failure (NY classification stage III/IV), inflammatory bowel disease or celiac disease per chart review and/or medical history.
* Diagnosis of narrow angle glaucoma or retinal disorders or demonstrated symptoms indicative of these diagnosis during the eligibility screening.
* Moderate to severe depression (score ≥ 21 or any endorsement of suicidal intent on the Beck Depression Inventory) 19
* Sleep apnea (score high risk in 2 or more categories of the Berlin Questionnaire) 20
* Restless leg syndrome (score ≥ 15 on the IRLS Study Group Rating Scale) 21
* Inability or unwillingness of subject to sign an informed consent
DETECT-RPC Universal EM Screening

The purpose of this study is to evaluate whether the use of the Detection of Elder Mistreatment Through Emergency Care Technicians-Revised for Primary Care (DETECT-RPC) screening tool increases the average reporting of elder mistreatment (EM) by homebased primary care (HBPC) clinicians.


Eligibility Criteria:
Inclusion Criteria (physicians):

* Clinician who actively provides home-based primary care to patients enrolled in one of our partner home-based primary care programs at least part time.

Exclusion Criteria:

-

Inclusion Criteria (patients):

* in home-based primary care
* 60 years or older
* seen by a clinician participating in the study

Exclusion Criteria:

-
Evaluation and Comparison of Two Biomarkers (VOP and SCC) for the Prognosis of the Occurrence of Clinical Cardiovascular Events

The aim of our study is to assess the Cardiovascular risk and the quality of the arteries by comparing the Coronary Calcium Score SCC measured with a CT scann and the Pulse Wave Velocity PWV measured with pOpmeter for the prognosis at 6 months of clinical events.

Is there a superiority of PWV compared to SCC:

Two method of cardiovascular risk screening are compared in patient going for Coronary Calcium Score measurement in a outpatient clinic. Ct Scann is expensive, learning time is for at least 2 years, and the reliability is operator dependent.

The Pulse Wave Velocity is measured using a new device with half an hour learning curve, and you get a result within 2 minutes.

1. A non-invasive medical device vs invasive
2. A better benefit-risk ratio
3. A lower diagnostic cost both for equipment and for qualification for use and learning time

Eligibility Criteria:
Inclusion Criteria:

1. Subject aged over 18
2. Any Patient referred to the Bizet Clinic for a CT scan of the coronary arteries
3. Subject affiliated to a social security scheme or beneficiary of such a scheme
4. Lack of participation in another clinical study

Exclusion Criteria:

1. Minor patient
2. Patient with obliterating arterial disease of the lower limbs
3. Patient with Sore fingers and hands
4. Patient with arrhythmia that does not allow measurement of VOP
5. Patient with limb amputation
6. Major subject protected by law, under curatorship or tutorship