cyrilzakka/clinical-trials huggingface dataset:
Assessment of Capsule Endoscopy Scoring Index (CESI), Harvey-Bradshaw Index (HBI) and Biological Markers in Small Bowel Crohn's Disease (SBCD)

Background: Small bowel Crohn's disease (SBCD) is a chronic relapsing disease, and clinical presentation can vary considerably. Patients are frequently assessed by capsule endoscopy (CE), which enables direct visualization of small bowel mucosal abnormalities; however, the correlations between CE scoring index (CESI), biological markers, and disease activity indices remain undefined.

Methods: A prospective study was conducted between October 2008 and February 2011 on 58 established SBCD patients and suspected patients who received a definitive SBCD diagnosis during study. Patients underwent complete CE, and were scored according to the CESI (inactive, \<135; mild inflammation, 135-790; moderate-severe inflammation, \>790) and Harvey-Bradshaw index (HBI). Statistical correlation between CESI, HBI, C-reactive protein (CRP), serum albumin, and hemoglobin was assessed. At follow-up (\~9 months), 11 of the patients underwent CE with scoring for CESI, HBI, and CRP.

Parameters CESI To calculate the CESI, the small bowel was divided into three tertiles. The degree of disease involvement in each tertile was determined by assessing three parameters: villous edema, ulceration, and stenosis. Endoscopic remission was defined as CESI of \<135. Mild inflammation was defined as CESI of 135-790, and moderate-severe inflammation as ≥790.

HBI HBI was used to assess the clinical disease activity. Patients with HBI \>4 were considered to have clinically active disease.\[7\]

Blood analysis At the time of CE, patients provided a blood sample for measurement of hemoglobin, serum CRP, and albumin. Hemoglobin (normal ranges: women, 120-160 g/L and men, 140-180 g/L), albumin (normal range: 35-55 g/L), and CRP (upper limit of normal: \<8 mg/L) were determined by routine laboratory tests.

Eligibility Criteria:
Inclusion Criteria:

* patients with known SBCD or newly diagnosed SBCD
* those patients for whom complete CE examination (in which the capsule
* reached the cecum within the CE test time) was achieved were retained for study

Exclusion Criteria:

* incomplete CE examination
* infectious enterocolitis
* symptoms related to perianal penetrating disease
* gastrointestinal cancer
* ulcerative colitis
* indeterminate colitis
* history of extensive small bowel resection
* known CD of the upper gastrointestinal tract or colon
* intake of non-steroidal anti-inflammatory drugs (NSAIDs) (more than two tablets per week)
* pregnancy
Osteoporotic Vertebral Compression Fractures: Can Kyphoplasty Improve Lung Function? A Prospective Evaluation

Patients with vertebral fractures often have problems to straighten and as a consequence of impaired lung ventilation that leads to a impaired lung function. Furthermore, it comes to the sintering of the vertebra and a so-called hunchback. This also contributes to the poorer expansion of the lung. Pain is also caused by respiratory excursions of the chest which hinder the patients to use their entire lung volume.

Kyphoplasty is designed to counter all these consequences of vertebral fractures by bringing stability to the fracture.

In order to prove the thesis the results of lung function test (FEV1, PEF) are assessed.


Eligibility Criteria:
Inclusion Criteria:

* over 50 years
* VAS over 49, ODI over 29
* radiographic evidence of A 1.1, 1.2, 1.3 fractures
* patients mentally capable to sign informed consent

Exclusion Criteria:

* high-energy trauma
* known tumor involvement
* osteonecrotic fractures
* burst fractures or pedicle fractures
* previous surgical treatment for a vertebral body compression fracture
* patient has paget's disease
* BMI \> 35
* uncontrolled diabetes HbAc1c \> 7%
* severe cardiopulmonary disease
* Myelopathy
* long-time steroid therapy
Exploring the Effects of Aquatic Exercise on Cardiovascular Function in Older Adults

Cardiovascular ageing is implicated in the development of cardiovascular disease (CVD). Aquatic exercise is being considered as a co-adjuvant form of rehabilitation, but there is limited evidence for its cardiovascular risk-reduction properties for older people. Our study aims to address this by exploring the cardiovascular effects of long-term aquatic exercise in older adults in comparison to those who are either inactive or engaged in land-based/mixed training by measurement of micro- and macro-circulation.


Eligibility Criteria:
Inclusion Criteria:

* being over 55 years of age and normotensive (e.g., \<140/90 mm Hg).

Exclusion Criteria:

* any overt chronic disease which would affect microvascular functioning,
* anaemia (irrespective of whether an iron supplementation course is followed or not)
* a recent (3 months' ago) major surgery
* None of the participants were undertaking high intensity interval training of any form.
Sublingual Versus Endovenous Fentanyl for the Prehospital Analgesia in Patients With Limb Trauma on the Slope

The purpose of this study is to determine the non-inferiority of the efficacy for prehospital analgesia of sublingual administered fentanyl versus endovenous administered fentanyl for patients with limb trauma on the slope

Fentanyl endovenous (ev) is an excellent analgesic drug for pain relief in acute traumatic pain. Fentanyl sublingual (Abstral ®) is an excellent analgesic drug in the breakthrough cancer pain relief in oncologic patients.

The immediate (less than 10 minutes) effect and the ease of administration of sublingual fentanyl is a feasible drug administration for immediate analgesia in remote areas such as mountain rescue missions eg. the slope.

Patients will be recruited according to a randomized list to fentanyl ev or fentanyl sublingual versus placebo oral or placebo ev.

Safety issues like control of vital signs will be warranted.

Eligibility Criteria:
Inclusion Criteria:

* Trauma on the limbs with a pain score of 4 or more on the slope
* ASA I - II

Exclusion Criteria:

* children (\< 18 years)
* cognitive impairment: brain injury, intoxication, analgesia
* weight under 50 kg and more than 100 kg
* other injuries like chest trauma with respiratory insufficiency, suspect liver or spleen injury, amputation;
* chronic analgesic use or misuse
* allergy
* fear of needles
* pregnancy
* speech difficulties
Screening for Pancreatic Exocrine Insufficieny in Metabolic Associated Fatty Liver Disease Patients

to investigate the frequency of PEI in MAFLD

The growing epidemic of obesity is observed worldwide as lifestyles change to include higher caloric diets and decreasing physical activity.

With obesity; ectopic fat deposition in certain organs is accompanied by insulin resistance, hypertension and dyslipidemia; which in turn leads to metabolic syndrome As such, metabolic associated fatty liver disease (MAFLD), the hepatic manifestation of metabolic syndrome, has already become the most common cause of liver disease worldwide with a prevalence 25% Another important organ where ectopic fat deposition takes place is pancreas. Although hepatic fat is mainly intracellular and fatty pancreas is a consequence of adipocyte infiltration, evidence exists that fatty pancreas could be used as the initial indicator of ectopic fat deposition Recently, an advanced MRI technique - MRI-estimated proton density fat fraction (MRI-PDFF) - was shown to give reliable quantitative information of hepatic fat that is well correlated with liver biopsy The pancreas is composed of two glands - endocrine pancreas and exocrine pancreas- that are intimately mixed together into one organ Although exocrine pancreas comprise more than 95% of the pancreatic mass, to date there is no study conducted about the exocrine pancreas function and pancreatic fat in MAFLD patients The fecal pancreatic elastase (PE) test is a valuable indirect assay used in the evaluation of pancreatic exocrine function PE testing has become a standard diagnostic tool exhibiting good correlation with the results of direct functional tests as well as morphological changes in the pancreas discovered via imaging techniques In the last decade, significant number of studies were conducted on pancreatic exocrine insufficiency (PEI)

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years, Patients diagnosed as MAFLD

Exclusion Criteria:

* Patients use steatogenic medications, hormone replacement therapy or herbal products, any alcohol intake.

  * Patients with any history of pancreatic diseases like acute pancreatitis, chronic pancreatitis and pancreatic surgery.
  * Patients with any malignancy.
Relationship Between Respiratory Functional Tests and Image Thoracic Techniques in Patients With Neuromuscular Diseases

It is very important monitoring respiratory muscle function in patients with amyotrophic lateral sclerosis (ALS). We have at our disposal Respiratory Functional Tests (forced vital capacity (FVC), maximal mouth-inspiratory force (MIF), maximal mouth-expiratory force (MEF), Cough Peak expiratory flow (cPEF), maximal voluntary ventilation (MVV), arterial blood gases and nocturnal pulsioxymetry) and Thoracic Image Techniques (inspiratory/expiratory Thorax x-ray and x-ray scope). But all this explorations present some technique limitations. They are two new methods to explore diaphragmatic function: SNIF test and Diaphragm magnetic resonance imaging (dMRI). SNIF test is simple and easy to be done and it can avoid some problems that have the other respiratory functional test in this kind of patients. dMRI seems to correlate with respiratory functional test and it can be useful monitoring diaphragmatic mobility. The objective of our study is to compare and to correlate SNIF test and dMRI with x-ray techniques and respiratory functional tests that measure diaphragmatic force and function. First of all we will study 10 healthy people with a forced spirometry, MIF, MEF and dMRI, trying to obtain diaphragmatic mobility reference values with dMRI. Lately, we will study patients with ALS. In the first place, we will perform a transversal study with 30 patients. We will do a forced spirometry, MIF, MEF, MVV, cPEF, SNIF, arterial blood gases and nocturnal pulsioxymetry, forced Inspiratory and expiratory Thorax x-ray, diaphragmatic x-ray scope and dMRI. Secondly, we will perform a prospective study, where we will analyze these variables evolution at 3 and 6 months. We hope we can apply the two new techniques in the future because we think they are simpler, more accurate and more objective to evaluate diaphragmatic mobility.


Eligibility Criteria:
Inclusion Criteria:

* Amyotrophic lateral sclerosis patients.
* Clinically stable, at least for one month.

Exclusion Criteria:

* Claustrophobic patients.
* Patients using continuous non-invasive ventilation treatment.
* Incapacity to tolerate supine decubitus.
* Incapacity to execute respiratory functional tests.
Standard Immunosuppressive Therapy Combined With Romiplostim N01 as First-line Treatment for Severe Aplastic Anemia

This prospective, single center, single-arm study aims to evaluate the efficacy and safety of anti-human T lymphocyte porcine immunoglobulin (p-ALG) in combination with cyclosporine and Romiplostim in treating severe aplastic anemia (SAA). It will include 48 patients with newly diagnosed SAA.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 12 years
* Diagnosis of severe or very severe aplastic anemia
* Patients are unconditionally or unacceptable undergoing allogeneic hematopoietic stem cell transplantation
* ECOG performance status ≤2
* Willing and able to comply with the requirements for this study and written informed consent.

Exclusion Criteria:

* Received \> 4 weeks of TPO-RA drug before treatment
* Received \> 4 weeks of immunosuppressive therapy before treatment
* History of thromboembolic disease
* Intolerance to Romiplostim N01 or cyclosporine
* Allergy to ALG
* Presence of uncontrolled active infection
* Presence of uncontrolled hypertension (≥140/90mmHg), diabetes mellitus (fasting blood glucose≥ 7.0 mmol/L or random blood glucose ≥ 11.1 mmol/L)
* Abnormal liver and kidney function: Aspartate Transaminase (AST) or Alanine Transaminase (ALT) \> 3 ULN, creatinine ≥ 2.5 ULN
* History of chemoradiotherapy for malignant solid tumors
* History of other systemic serious illnesses
* Females who are pregnant/lactating or need pregnancy
* Patients considered to be ineligible for the study by the investigator for reasons other than the above
Topical NVN1000 for the Treatment of External Genital and Perianal Warts

A Phase 2 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Ascending Dose Study Assessing Tolerability, Safety, and Efficacy of Topical NVN1000 in Subjects with External Genital Warts and Perianal Warts

This is a phase 2, multi-center, randomized, double-blind, vehicle-controlled, ascending dose study to assess safety, tolerability and efficacy of a topical nitric oxide releasing compound in subjects with external genital and perianal warts. Eligible subjects will be treated with a topical gel (active or vehicle) for up to 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* At least 2 but not more than 20 genital/perianal warts with a maximum total wart surface area no more than 1% body surface area
* If a woman of child-bearing potential, have a negative pregnancy test and use effective contraception
* If currently receiving wart treatment, be willing to stop all treatment for 28 days prior to randomization and during the study

Exclusion Criteria:

* Immunocompromised patients including those with HIV, receiving radiation, or drugs that suppress the immune system
* Pregnant, planning to become pregnant, or nursing
* History of cancer (including cervical cancer) within 5 years, with exception of non-melanoma skin cancer in non-genital skin
* Recent history of other genital skin infections
* Active HSV and frequent HSV recurrences unless receiving suppression therapy
* Have hemoglobin \< 10 G/dl or methemoglobin \> 3%
* Known allergy to any component of the gel including excipients
* Previously participated in any study with NVN1000 or SB204
Efficiency Evaluation of Intradiploic Intra-osseus Anesthesia Versus Inferior Alveolar Nerve Block

Management of dental pain emergencies is a challenge for the clinician, particularly when pain is due to endodontic infection.

Tested hypothesis is intradiploic anesthesia is more effective and quicker than inferior alveolar nerve block for mandibular molars anesthesia.

The aim of the study is the evaluation of Quicksleeper efficiency used in first intention versus inferior alveolar nerve block used in most current dental treatment.

Management of dental pain emergencies is a challenge for the clinician, particularly when pain is due to endodontic infection. Failure rate of local anesthesia highly increases with irreversible pulpitis or inflamed periradicular tissue.

Tested hypothesis is intradiploic anesthesia is more effective and quicker than inferior alveolar nerve block for mandibular molars anesthesia (from teeth 35 up to 38 and from 45 up to 48).

The primary aim of the study is the evaluation of Quicksleeper efficiency used in first intention versus inferior alveolar nerve block used in most current dental treatment.

Four clinical situations are evaluated : pulpitis; periapical abcess; pulpal hyperemia; asymptomatic decayed tooth.

Evaluated parameters are : speed of sedation, ability of cure, additional anesthesia needed, total of needles and cartridges used, side effects. Time and validation of complete anesthesia is controlled by pulp tester.

Studied population is patients cared in restorative, endodontics department.

Pulpal and periapical molar and premolar sedation is randomly managed by inferior alveolar nerve block or Quicksleeper intraosseous anesthesia, among studied population (divided in 2 groups of 50 patients). Pulp-tester measures anesthesia minute by minute.

The comparison of study results to bibliography, guidelines and advantages for using mechanical Quicksleeper anesthesia system will be discussed.

Eligibility Criteria:
Inclusion Criteria:

* Irreversible pulpitis on second mandibular premolar or mandibular molars
* Necessity of pulpotomy or pulpectomy

Exclusion Criteria:

* Pregnancy, chest feeding
* Non dental emergency state
* hypersensibility to local anesthesia
* Pheochromocytoma
* Irregularity of cardiac rhythm
* Myocardial infarct in the 6 previous months
* Hepatic porphyria
Rescue Progesterone Supplementation During Frozen Embryo Transfer

Endometrin is a progesterone supplement prescribed during in vitro fertilization (IVF) for preparation for embryo transfer. The usual dose of Endometrin is 100 mg two to three times per day in the form of an effervescent tablet to be inserted vaginally.

The purpose of this research project is to evaluate the dose response of the Endometrin when determined based on the blood level of progesterone on the day of the FET. According to the literature, a predefined level of progesterone in the blood should be reached in order to have favorable conditions for pregnancy. The hypothesis being that a woman with low progesterone levels would benefit from a dose of Endometrin of 600 mg (200 mg 3x/day) to decrease the risk of miscarriage and improve the chances of pregnancy. Women with adequate progesterone levels according to the literature, would continue with the standard dose of progesterone prescribed at clinique ovo which is 300 mg (100 mg 3x/day).

PIBF (Progesterone Induced Blocking Factor) levels, a protein found in the blood that could also predict pregnancy outcomes in women using IVF will also be looked at.


Eligibility Criteria:
Inclusion Criteria:

* Women 18-42 years of age
* Normal uterine cavity (according to treating physician)
* FET substituted cycle prescribed
* First or second cycle of FET
* Adequate endometrial pattern (triple layer) and thickness (\>7 mm) after adequate standard endometrial preparation in artificial cycle

Exclusion Criteria:

* Any uterine abnormalities confirmed by treating physician making participant unable to proceed with FET
* Patients with personalized FET according to the endometrial receptivity assay tests
* Previous allergic reactions to progesterone or any of the ingredients of Endometrin
* Severe hepatic dysfunction or disease
* Known or suspected breast cancer or genital tract cancer
* Known active arterial or venous thromboembolism or severe thrombophlebitis or cerebro-vascular disease, or a history of these events
* Diagnosed porphyria
* Undiagnosed abnormal vaginal bleeding
* Known missed abortion or ectopic pregnancy
* Recurrent pregnancy loss excluding biochemical pregnancies
* Hypersensitivity to Acetylsalicylic acid (ASA), salicylates, non-steroidal anti-inflammatory drugs (NSAIDs), analgesics, antipyretics or other ingredients in the product or component of the container
* Acute gastrointestinal ulcer, history of gastrointestinal ulcers and hemorrhagic diathesis
* Active or severe renal disease, or congestive heart failure
* History of asthma induced by salicylates or other NSAIDs
* Use of methotrexate at doses of 15mg/week or more
* Glucose-6-phosphate dehydrogenase (G6PD) deficiency
Evaluation of Mirus™ for Sedation in Resuscitation

Current recommendations for the conduct of sédationanalgésie ICU encourage the use of the lightest possible sedation strategies, avoiding the administration of benzodiazepines source of longer durations of ventilation and ICU stay of syndrome cessation, mental confusion. Among the proposed alternatives, administration of halogenated volatile agents (sevoflurane) in resuscitation is interesting because their favorable pharmacokinetic even after prolonged administration: no tachyphylaxis, rapid clearance, no withdrawal syndrome.

There are two suitable delivery devices sevoflurane in intensive care, both with CE marking. The device Mirus ™ (Pall Medical, Fribourg, Switzerland) is the newest and it is easy to use and reliable. The objective of this study was to evaluate the use of Mirus ™ device in trauma resuscitation and cardiovascular resuscitation.

Specifically, it will use this modality in case of failure with conventional sedation products (propofol, midazolam): maximum permissible doses, sedation weaning failure due to severe agitation.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18 years
* In mechanical ventilation for more than 48 hours
* No intracranial hypertension
* In severe state of agitation measured by a sedation scale score greater than 2 RASS
* Agitation observed in two circumstances: receiving maximal doses of propofol (≥ 5 mg / kg / h) and / or midazolam (≥ 0.2 mg / kg / h), or weaning failure to stop the sedation agitation.

Exclusion Criteria:

* Presence of a severe head injury (Glasgow initial score between 3 and 8) requiring monitoring intracranial pressure and / or treatment of intracranial hypertension
* Sedation with dexmedetomidine
* Personal or family antecedent of anesthetic malignant hyperthermia
* Pregnant woman
A Phase 2 Study to Evaluate Effects of VX-661/Ivacaftor on Lung and Extrapulmonary Systems in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation

To evaluate the clinical mechanisms of action in lung and extrapulmonary systems of VX-661 (tezacaftor; TEZ) in combination with ivacaftor (IVA) (TEZ/IVA) in participants with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants, homozygous for the F508del CFTR mutation
* Confirmed diagnosis of CF by sweat chloride testing
* Forced Expiratory Volume in 1 Second (FEV1) ≥40% and ≤90% of predicted normal for age, sex, and height at Screening Visit
* Stable CF disease as judged by the investigator.

Exclusion Criteria:

* History of any comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject.
* An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy for pulmonary disease within 28 days before Day 1
* History or evidence of clinically significant findings on ophthalmologic examination during the Screening Period.
* History of solid organ or hematological transplantation
* Pregnant or nursing females
* Participants who have had radiation exposure within 1 year before the first mucociliary clearance (MCC) procedure that would cause them to exceed federal regulations by participating in this study
* In the opinion of the investigator, unable to adequately perform inhalation maneuvers during the MCC procedures
Upright Magnetic Resonance Imaging (MRI) Study - Breast Implant Shell Geometry and Edge Scalloping

The purpose of this study is to determine how different types of breast implants contour to the chest wall.


Eligibility Criteria:
Inclusion Criteria:

* had previous primary breast augmentation
* had previous replacement of breast implants
* has Baker Class I breast implant capsule

Exclusion Criteria:

* has scar capsule contracture around the breast implants of Baker Class II-IV
* is pregnant or may be pregnant
* has possibility or previous history of metallic foreign body