cyrilzakka/clinical-trials huggingface dataset:
Hyperinflation Assessment After Treatment by Lung Volume Reduction Coil

Hyperinflation Assessment After Treatment by Lung Volume Reduction Coil (HEAT-LVRC) on Hyperinflation in Severe Emphysema

Two sequences (around 30 minutes) are necessary by patient. Under general anesthesia, two lobs treatment ( 10 Coil by lob) successively introduced by a bronchoscope.

Eligibility Criteria:
Inclusion Criteria:

* Severe emphysema (recent CT-scan (\< 6 mois) )
* Age \> 35 ans
* Modified Medical Research Council Scale (mMRC) \> 2
* Forced expiratory volume in one second (FEV1) post-bronchodilatator \< 45%
* Residual volume \> 175%
* Total Pulmonary capacity \> 100%

Exclusion Criteria:

* Forced expiratory volume in one second (FEV1) variability \> 20% after bronchodilatator
* Carbon Monoxide Diffusing Capacity (TLCO) \< 20%
* Recurrent respiratory infection Infections with clinics symptoms
* Pulmonary arterial hypertension (PAH) with Pulmonary Arterial Systolic Pressure (PAPS) estimated with echography \> 50 mm Hg
* Impossibility to walk more that 140 meter (6 min test)
* Surgery history of volume reduction or pulmonary transplantation
* Broncho-dilatation with clinic symptoms
Clinical Observation of Implementing the MedGem Into a Medical Specialty Practice

Due to common CVD diseases associated from obesity, medical providers are in a position to provide assistance. However, less than 10% of all patients receive any weight loss advice from physicians. Perceived barriers to weight loss counseling include lack of self-control of their patients and belief that recommendation is futile, lack of medical training in nutrition, exercise, and obesity management, and lack of insurance reimbursement. Though many barriers are prevalent, research has demonstrated a positive effect with medical advice on the number of obese individuals attempting to lose weight. Analyzing data from the 1996 Behavioral Risk Factor Surveillance System, researchers found, when advised to lose weight by a physician, 78% of overweight patients reported attempting to lose weight. However, if their physician did not discuss weight loss, only 33% of patients within the same BMI category attempted to do so 7. From this information, physicians or allied health staff that provide brief counseling (5-10 minute) along with medical technology that provides basic nutrition assessment might have a positive impact on the number CVD patients that are obese attempting to lose weight.

HYPOTHESIS: Will a medical specialty clinic focused on cardiovascular medicine successfully be able to implement the MedGem device for assessment of basic nutritional needs along with providing "brief" patient education into the medical practice without a house dietitian.

PRIMARY AIMS

1. Can medical staff and/or support staff provide REE assessments (15-minutes) and brief patient education (5-15 minutes) as part of the clinic's operations?
2. Will a third-party payer compensate the Medical Specialty Clinic for the diagnostic procedure CPT Code 94690 for obese patients diagnosed with hypertension (401.1-9, 402.10-11, \& 402.90-91), hypercholesterolemia (272.1), and/or hyperlipdemia (272.2)?

SECONDARY AIMS

1. Does self-efficacy increase from REE assessments?
2. Do patients adopt healthy eating (Calorie Reduction and Fat Reduction)following REE assessments?


Eligibility Criteria:
Inclusion Criteria:

* Patients with a BMI (Body Mass Index \> 30.0 kg/m2)
* Patients Diagnosed with any of the following ICD-9 Codes: Hypertension (401.1), Hypercholesterolemia (272.1), and/or Hyperlipdemia (272.2-4)
* Patients diagnosed with a secondary ICD-9 Code: Obesity (278) or Morbid Obesity (278.01)

Exclusion Criteria:

* Patients that are pregnant
* Patients under the age of 18 years
8-week Study to Evaluate Safety and Efficacy of Various Combinations of Valsartan, HCTZ, and Amlodipine in Patients With Moderate to Severe Hypertension

The purpose of this study is to determine the safety and efficacy of the various combinations of valsartan, HCTZ, and amlodipine in patients with moderate to severe hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of moderate to severe hypertension (MSDBP ≥ 100 mmHg and \< 120 mmHg, MSSBP ≥ 145 mmHg and \< 200 mmHg).

Exclusion Criteria:

* Patients on two or more antihypertensive drugs with MSSBP ≥ 180 mmHg and/or MSDBP ≥ 110 mmHg at Visit 1.
* Patients on three or more antihypertensive drugs with MSDBP ≥ 90 mmHg and \< 110 mmHg, and/or MSSBP ≥ 140 mmHg and \< 180 mmHg at Visit 1.
* Patients on four or more antihypertensive drugs at Visit 1.
* Arm circumference \> 42 cm for patients participating in ABPM.

Other protocol-defined exclusion criteria may apply.
Perioperative Reduction of Inapparent Myocardial Injury

Recent data suggests that subclinical myocardial injury occurs in patients undergoing major abdominal surgery, and the degree of damage is proportionally linked to morbidity and mortality in the short and medium terms. Therefore, new methods of limiting myocardial damage are urgently needed.

Ischemic preconditioning is a phenomenon whereby a brief non-lethal ischemia-reperfusion stimulus gives a protective effect to further ischemic insults. In remote ischemic preconditioning (RIPC), this initial stimulus is carried out away from the region of interest, normally a limb. In meta-analysed syntheses the effect size of RIPC in reducing cardiac damage during bypass grafting, as characterised by troponin release, seems to be about 35%.

The PRIME Study will assess the value of RIPC in reducing subclinical myocardial injury in patients undergoing major abdominal surgery. Post-operative troponin release will be used as a surrogate marker of myocardial damage. There is no good data on which to build a reliable sample size calculation, therefore we estimated samples sizes using supplementary data from the recent VISION study. The investigators intend to build a clinically powered study from the results of this study.

Study design will be by single-centre single-blind randomised control trial. Allocation will be 1:1. All treatments will be carried after induction of anaesthesia, prior to surgery. In the RIPC-treatment group, a blood pressure cuff inflated on an upper limb to 200mmHg for 5 minutes, and then deflated for 5 minutes, repeated in three cycles. In the control group, the blood pressure cuff will not be inflated, but the patient will remain under anaesthesia for the same amount of time.

Primary endpoint will be peak post-operative 5th generation hs-TnT (highly sensitive Troponin-T, ng/ml). Secondary endpoint will be hs-TnT area-under-the-curve, major adverse cardiovascular events, serious surgical complications, non-cardiovascular death, quality of life, and length of stay.


Eligibility Criteria:
Inclusion Criteria:

* is ≥ 45 years old;
* is undergoing elective major colorectal or upper GI surgery.

Exclusion Criteria

* Diabetic patients that are taking glibenclamide medication
* Patients with upper limb peripheral vascular disease, including those with arteriovenous fistula for dialysis
* Untreated hypertension (defined as two or more readings \>180mmHg systolic on admission for surgery)
* Current participation in any study investigating troponin levels or ischaemic preconditioning
* Unable or lacks capacity to give informed consent to participation
Evaluation of the Added Value of Sophrology on the Intensity of Craving During Smoking Withdrawal

To evaluate the added value of Sophrology on the intensity of craving during cigarette withdrawal.

Pilot study to evaluate the impact of sophrology on the intensity of craving and on certain determinants of cigarette consumption: number of cigarettes, anxiety, degree of dependence, motivation, confidence, fatigue, irritability, quality of sleep.

This pilot study could serve as a basis for the development of research on a larger cohort.

Eligibility Criteria:
Inclusion Criteria:

* First outpatient consultation in tobacco addiction department
* Consumption greater than or equal to 35 cigarettes per week
* Minimum age: 18 years old / Maximum age: 75 years old
* Absence of co-addiction of alcohol, other products and behavioural addictions (except if withdrawal for more than 1 year)
* Commitment by the patient not to practice hypnosis or mindfulness while participating in the study
* Mastering reading and writing skills
* Acceptance to participate in the protocol
* Affiliated to a social security system

Exclusion Criteria:

* Patient-reported psychosis
* Pregnant women
* Participation in other intervention research
* Patient under guardianship or curatorship
* Refusal to participate in the study
Duration of Ureteral Rest Prior to Ureteral Reconstruction Surgery

Our objective is to assess the effect of duration of ureteral rest, defined as time from conversion of ureteral stent to percutaneous nephrostomy, on stricture length prior to ureteral reconstruction surgery.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age
* Undergoing ureteral reconstruction surgery for ureteral stricture with conversion of an indwelling stent to a percutaneous nephrostomy tube for ureteral rest
* Willing to sign informed consent form
* Able to read and understand informed consent form

Exclusion Criteria:

* \<18 years of age
* Inability to provide informed consent
* Members of vulnerable patient populations
Spinal Plasticity to Enhance Motor Retraining After Stroke

The objective of this project is to study the effects of an emerging noninvasive neuromodulation strategy in human stroke survivors with movement-related disability. Muscle weakness after stroke results from the abnormal interaction between cells in the brain that send commands to control movement and cells in the spinal cord that cause muscles to produce movement. The neuromodulation strategy central to this project has been shown the strengthen the physical connection between both cells, producing a change in movement potential of muscles weakened by stroke.

Stroke is a leading cause of serious long-term disability in the United States with 795,000 individuals suffering a new or recurrent stroke each year. In most cases, disability is associated with incomplete motor recovery of the paretic limb. Full recovery is often not achieved, creating a need for neuromodulation strategies that target the physiological mechanisms impaired by stroke to fully harness the adaptive capacity of the nervous system. The neuromodulation protocol that will be tested in these experiments will target connections between the brain and spinal cord with noninvasive stimulation to enhance movement potential of the hand. Individuals who experienced a single stroke at least 6 months ago may be eligible to participate.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 75 years old
* Diagnosis of first-ever stroke
* Stroke onset of at least six months prior to the time of participation

Exclusion Criteria:

* History of seizure or epilepsy
* Ferromagnetic metallic implants, pacemakers, other implanted devices, or ventilators (for subjects undergoing MRI)
* Pregnant or expecting to become pregnant
* Difficulty maintaining alertness and/or remaining still
* Body weight \> 300 lbs due to MRI scanner dimensions (for subjects undergoing MRI)
* Cognitive or language impairments that would interfere with the ability to follow simple instructions, as judged by the investigators
* Diagnosis of movement disorder(s) other than stroke
Oral DS107 in Moderate to Severe Atopic Dermatitis

This study will compare the safety and efficacy of Oral DS107 (2 g) to placebo in patients with moderate to severe atopic dermatitis.

Oral DS107 (2 g) will be orally administered for 8 weeks, and will be compared against placebo.

This study will enroll approximately 100 adult patients.

Subjects will come to the clinic on 6 occasions: at screening, baseline, week 2, week 4, week 8 (end of treatment/early termination) and week 10 (follow-up). The primary efficacy variable will be the IGA. Secondary efficacy variables will include IGA (Investigator's Global Assessment), SCORAD (Scoring Atopic Dermatitis) Visual Analog Scale (VAS), EASI, BSA (Body Surface Area), POEM (Patient Orientated Eczema Measure), DLQI (Dermatology Life Quality Index).

Eligibility Criteria:
Inclusion Criteria:

* Male or female subject aged 18 years and older.
* Moderate to severe atopic dermatitis.

Exclusion Criteria:

* Clinically significant impairment of renal or hepatic function.
* History of hypersensitivity to any substance in Oral DS107 or placebo capsules.
* Treatment with any experimental drug within 30 days prior to Day 0 visit (baseline).
* Excessive sun exposure, use of tanning booths or other ultraviolet (UV) light sources and/or is planning a trip to sunny climate.
The Impact of Additional Oral Preparation on the Quality of Bowel Preparation for Colonoscopy

Although adequate bowel preparation is essential for successful colonoscopy, the 23% of patients had shown inadequate bowel preparation. Inadequate bowel preparation may results in incomplete examination, increased patient's discomfort, decreased polyp detection rates, ultimately leading to repeated colonoscopies. One prior study showed that patients reporting their last rectal effluents as brown color or solid stool had a 54% chance of having fair or poor preparation. Thus, recent consensus guideline suggested consideration of additional oral preparation in patients presenting brown effluents on the day of colonoscopy. However, the data supporting additional oral preparation is still spares. Therefore, the investigators aimed to examine the impact of additional oral preparation on the quality of bowel preparation for colonoscopy in patients showing brown effluents on the day of colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

* patients who reporting their last rectal effluents as brown color or solid stool on the day colonoscopy

Exclusion Criteria:

* known hypersensitivity to polyethylene glycol
* severe congestive heart failure \[New York Heart Association (NYHA) grade III or grade IV\]
* severe renal insufficiency (creatinine clearance \<30 ml/min)
* hemodynamic instability
* suspected intestinal obstruction or perforation
* compromised swallowing reflex or altered mental status
* pregnancy or lactating woman
* patients who declined to participate
Comparing Efficacy & Safety of Tacrolimus With/Without MMF or Monoclonal Anti-IL2R Antibody in Liver Transplantation.

To compare the efficacy and safety of two regimens containing tacrolimus and minimal steroids together with either monoclonal anti-IL2R antibodies (daclizumab) or mycophenolate mofetil.

This prospective randomised trial which combines MMF with tacrolimus and so avoids steroids in immunosuppressive maintenance could demonstrate alternatives to current immunosuppressive regimens. There is evidence that reduced steroid usage could further decrease the onset of diabetes mellitus, hypertension and viral infections combined with high efficacy for patients and graft survival. Since the use of MMF in liver transplantation is becoming an alternative in the rescue setting this could contribute to a steroid-free immunosuppressive approach.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older who will undergo primary orthotopic liver or split liver allograft transplantation are eligible for the study. Patients receiving a liver transplant from cadaveric heart-beating donor with compatible AB0 blood type can be included.

Exclusion Criteria:

* Recipient of an auxiliary graft
* Patient is requiring initial sequential or parallel therapy with other immunosuppressive antibody preparation(s).
* Patient is requiring ongoing dosing with corticosteroids.
* Patient is exhibiting symptoms of, or is having any previous history of neoplastic disease
* Patient or donor is known to be HIV positive.
* Patient is allergic or intolerant to study medication
A Comparison of Different Ventilation Strategies in Infants Using the PLMA™

The purpose of this research study is to compare difference between breathing by oneself or with the partial help from an anesthesia machine in infants under general anesthesia.

Hypothesis: Infants undergoing general anesthesia with a PLMA™ will be better ventilated (improved breathing) with the help of the breathing machine versus breathing on their own.

The laryngeal mask airway (LMA) is a breathing device that sits above the vocal cords and allows the patient to breathe in and out adequately under general anesthesia (GA). The ProSeal™ laryngeal mask airway (PLMA™) is a specialized type of LMA with a design that permits the delivery of higher pressures to help the patient breathe in and out (ventilate) and also contains a channel to suction the stomach.

Infants under GA may breathe through a PLMA in different ways. Spontaneous ventilation consists of the infants breathing on their own through a PLMA™. Pressure support ventilation allows the patient to breathe on their own with additional help from the anesthesia machine. Pressure control ventilation allows the patient to breathe with the help of an anesthesia machine.

An infant undergoing surgery requires a deep level of general anesthesia which negatively affects their ability to ventilate. Thus, infants may not breathe in oxygen and carbon dioxide out adequately at this level of anesthesia and it may be beneficial to provide some level of support to enhance carbon dioxide exchange and to avoid hypoventilation.

This study will attempt to determine whether pressure support ventilation improves ventilation in infants undergoing outpatient surgery.

Eligibility Criteria:
Inclusion Criteria:

1. ASA (American Society of Anesthesiologists) physical classification of 1 or 2
2. Outpatient surgical procedures
3. Surgical procedure anticipated to be \< 90 minutes
4. Subject age of 1 - 11 months (inclusive)

Exclusion Criteria:

1. Inpatient- Such individuals may have underlying disease processes which puts them at an increased risk under general anesthesia for hypoventilation
2. ASA physical classification of 3, 4 or E
3. Premature infants or infants \< 44 weeks post-conceptual age
4. Risk of aspiration- Intubation with an endotracheal tube may be required for general anesthesia.
5. Patients with malignant hyperthermia or family history of malignant hyperthermia- Administration of inhalational agents for general anesthesia is contraindicated.
6. Patients with tracheostomies- The individual's airway is already established and PLMA™ placement is not required.
PTNS vs Botox of Refractory OAB

This is a prospective cohort study of women with overactive bladder OAB (dry or wet) who have failed 2 prior treatments, including behavioral modification, pelvic floor physical therapy, and/or OAB medication (anticholinergics or mirabegron), and have chosen either OnabotulinumtoxinA (BTX) injection or percutaneous tibial nerve stimulation (PTNS) as their next treatment. OAB-dry refers to patients with OAB who do not have urge urinary incontinence; OAB-wet refers to patients with OAB and urge urinary incontinence. Eligible patients will be approached for study participation after they have decided to proceed with BTX or PTNS.

Prior to initiation of BTX or PTNS, patients will undergo a standardized evaluation including urodynamics study (UDS) if not previously done in the past year and pelvic organ prolapse quantification (POPq) exam if not previously done in past 6 months. Subjects will also complete quality of life questionnaires and 3-day voiding diary prior to initial treatment. Follow up questionnaires will be completed at 3 months either in office, if patient has a routine visit scheduled with provider and questionnaires can be completed at that visit or questionnaires will be mailed with return postage for participant to mail completed questionnaires back.

Eligibility Criteria:
Inclusion Criteria:

1. Women with refractory OAB (dry or wet)
2. OAB will be defined by a positive response and bother of "somewhat, quite a bit, a great deal, or a very great deal" to question #3 or #8 on the OAB-q (see appendix B) regarding urinary urgency and urgency incontinence.
3. Refractory will be defined as failure of 2 prior treatments, including behavioral modification, pelvic floor physical therapy, and OAB medication (anticholinergics or mirabegron). Trial of 2 medications that did not improve symptoms after 2 weeks or could not be tolerated due to side effects will constitute 2 treatment failures.
4. Women with mixed urinary incontinence that is urge predominant will also be included.
5. Age ≥ 18 years
6. English speaking
7. Available for 1 year follow-up
8. Able to complete study questionnaires

Exclusion Criteria:

1. Neurologic disease known to cause OAB including, but not limited to, Multiple sclerosis, Parkinson's disease, and Spinal Cord Injury.
2. Pregnancy by self-report or pregnancy test
3. Contraindication to PTNS and/or BTX

   * PTNS: Pacemaker
   * BTX: myasthenia gravis, allergy to BTX, urinary retention (post void residual \>200cc)
4. Planned surgery for pelvic floor disorder during the study period
5. Prior treatment with BTX, PTNS, or sacral nerve stimulation (SNS) for refractory OAB/urinary urge incontinence (UUI)
Controlled Ovarian Stimulation by HP-hMG for IVF / ICSI Cycles: Study on Ovarian Hyper Stimulation Syndrome in a Cohort of Women From 18 to 36 Years Old.

Ovarian hyper stimulation syndrome (OHSS) is a potentially serious complication of ovarian stimulation in IVF (In Vitro Fertilisation). The main objective of this study is to describe the incidence of moderate or severe forms of OHSS in women between 18 and 36 years of age treated with HP-hMG.


Eligibility Criteria:
Inclusion Criteria:

* Women who present infertility of more than one year and are candidates for a first or second IVF cycle with or without ICSI for whom HP-hMG is prescribed for COS.
* Absence of infertility treatment during the last 3 months before enrolment.
* Age: from 18 to 36 years old.
* BMI between 18 and 30 kg / m².
* Presence of both ovaries accessible to puncture and absence of ovarian or uterine abnormalities.
* Male or female infertility.
* Ovarian stimulation by HP-hMG with pituitary desensitization by a GnRH agonist or antagonist.
* Normal ovarian reserve according to physician habitual evaluation.
* Consent to participate of the no-interventional study and signature of the patients' information sheet.

Exclusion Criteria:

* Presence of a chronic disease, cancer or endocrine disease that could potentially influence the results of the stimulation or that represents a contraindication for ovarian stimulation.
* Known endometriosis grade III or IV.
* Contraindication to the use of gonadotropins or current pregnancy diagnosed by the clinician.
* Recurrent miscarriages, known genetic disease of one of the partners or indication of a preimplantation genetic diagnosis (PGD).
* Smoking over than 10 cigarettes / day.´
* Participation in an interventional study at the time of inclusion.
* Known poor ovarian response in a previous cycle of stimulation (number of oocyte collected ≤ 3, and / or more than 2 previous IVF/ICSI cycles and / or abnormal result in ovarian reserve test (AMH \< 1 ng/ml with Immunotech equipment or AMH\<0.7 ng/ml with DSL equipment).