cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Fexofenadine in Mild to Moderate Persistent Asthma

The purpose of this study is to investigate the efficacy and safety of fexofenadine 120mg BID compared to placebo in the treatment of subjects with mild to moderate persistent asthma

The incidence of respiratory allergy in the US has increased gradually over the past several years, and current estimates suggest that allergic rhinitis and bronchial asthma affect approximately 20% and 5% of the population, respectively. Rhinitis and asthma frequently coexist, and large-scale population surveys indicate that up to 38% of subjects with rhinitis have asthma, and up to 78% of subjects with asthma have chronic nasal symptoms. Safety concerns with the increased use of inhaled corticosteroids, the heterogeneity of the disease, and poor compliance with asthma medication regimens, point to the need for the development of safe and convenient oral therapies for asthma. Histamine is an important chemical mediator of inflammation in asthma. The benefits of antihistamine treatment in patients with mild to moderate asthma have been well documented, however their clinical use has been previously limited due to the high doses required for efficacy and their associated side effects including sedation and cognitive impairment.

Recent evidence indicates that in addition to H1-receptor antagonism, some of the newer nonsedating, non-impairing antihistamines appear to possess various anti-inflammatory properties at concentrations achieved at therapeutic dosages suggesting an additional benefit of these drugs in the management of allergic diseases and asthma. The purpose of this study is to investigate the efficacy and safety of fexofenadine 120mg BID compared to placebo in the treatment of subjects with mild to moderate persistent asthma.

Eligibility Criteria:
Inclusion criteria:

* Males and non-pregnant, non-breastfeeding females 12 through 80 years of age
* FEV1 in the context of this study is greater than 60% and not less or equal to 87% of predicted values at Visit 1 or Visit 2 (and no short-acting agent beta-agonist use within 6 hours prior to spirometry)
* Improvement in FEV1 of at least 12% of predicted value and at least 200ml within 15 to 30 minutes of inhaling 2 puffs of albuterol 90mcg/actuation demonstrated at study entry OR documented during the previous 12 months at the study site.
* Use of a short-acting, beta-agonist inhaler to treat asthma symptoms on an average of at least 2 days per week during the previous 2 weeks (greater than or equal to 4 days total during the previous 2 weeks, excluding prophylactic use).

Exclusion criteria:

* Otherwise healthy
Relationship of YWHAH Polymorphisms to Rheumatoid Arthritis Disease Severity

It is hypothesized that one or several of these 6 single nucleotide polymorphisms (SNPs) (rs2246704, rs2853884, rs3747158, rs4820059, rs7291050, and rs933226) in the YWHAH gene could be related to RA disease severity.

Rheumatoid Arthritis (RA) is a chronic inflammatory arthritis of substantial morbidity. Serum biomarkers such as Rheumatoid Factor and anti-cyclic citrullinated peptide assist with disease diagnosis and prognostic assessment of future disease activity. 14-3-3 eta is a relatively new RA serum biomarker. The 14-3-3 family of proteins were named based on chromatographic elution properites and are ubiquitously expressed intracellular chaperon proteins. The isoform relevant in RA is 14-3-3 eta. 14-3-3 eta provides additional information about RA to the clinician-it assists in making diagnosis, provides prognostic assessment of disease severity, and provides insight regarding response to therapy. Thus, 14-3-3 eta serves as an important mechanistic biomarker informing the clinician about patient's RA.

14-3-3 eta is the product of the YWHAH gene, located on chromosome 22q12.3. It is about 13 kilobase long, consisting of two exons separated by a single intron. This gene has been implicated in linkage studies to bipolar disorder and schizophrenia. Six YWHAH single nucleotide polymorphisms (SNPs) were identified in a prior study: rs2246704, rs2853884, rs3747158, rs4820059, rs7291050, and rs933226. rs2246704 was associated with bipolar disorder (Odds Ratio (OR) 1.31, p=0.03) and psychotic BP (OR 1.66, p=0.002). All six SNPs are intronic. It was hypothesized that one or several of these 6 single nucleotide polymorphisms (SNPs) could be related to RA disease severity.

Eligibility Criteria:
Inclusion Criteria:

* Have RA per 1987 or 2010 American College of Rheumatology Classification Criteria

Exclusion Criteria:

* None
Comparison of Classical Ultrasound Screen and Combined Wearable Display in Interscalene Nerve Blocks

This study hypothesizes that the use of smart glasses (Head-mounted display Vufine, model VUF-110, Vufine Inc., China)) improves the hand-eye coordination and the first-attempt success rate of ultrasound guided interscalene nerve block. This is a single-center, randomized, controlled study comparing the real-time ultrasound image through smart glasses (intervention group) or the ultrasound machine's monitor (control group) during the interscalene block.

Peripheral nerve blocks, which help patients to recover early after surgery, are performed safely and successfully under ultrasound guidance. Ultrasound-guided peripheral nerve blocks provide sufficient anesthesia for the operation alone or can be applied in combination with general anesthesia and provide postoperative analgesia.

Investigators encounter new developments in health technologies almost every day. With the development of smart technologies and the spread of wearable devices, their use in the field of health is increasing day by day.

Hand-eye coordination is an important skill, especially in the use of ultrasound. The inserted needle should be followed during the procedure in the appropriate area and safely delivered to the desired area.

Patients will be divided into either the study group or the control group. Interscalene nerve block will be performed with preoperative sedation, ultrasound guidance and nerve stimulator.

Interscalene nerve block will be applied to the patients in the study group by using the smart glasses screen, and to the patients in the control group with the conventional ultrasound screen.

In this clinical study, the first trial success rate of the procedures, the time spent during the procedure, the overall success rate, the ergonomics of the practitioner, and the complications related to the block will be recorded and compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are planned to undergo surgery under general anesthesia
* Patients scheduled for postoperative analgesia after shoulder surgery

Exclusion Criteria:

* Local anesthetic allergy
* Skin disease, infection, hematoma
* Chronic obstructive pulmonary disease
* Hepatic, renal, cardiac failures
* Pregnancy
* Uncooperative patient
Pathogenic Study of Adult Immune Enteropathies

The study focuses the mechanisms underlying the loss of intestinal homeostasis in celiac disease, refractory celiac disease and other immune diseases such as monogenic enteropathy, inflammatory bowel diseases or drug induced intestinal diseases. Mechanisms of transformation of lymphocytes leading to onset of lymphomatous complications of immune enteropathies will be investigated. Mechanisms of loss of hepatic lymphocytic homeostasis will also be assessed in liver associated diseases.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or over
* affiliated to social insurance
* signed informed consent

Exclusion Criteria:

* pregnancy
* under guardianship
* not able to sign informed consent
Short Course Radiotherapy Combined With Chemotherapy in Stage IV Rectal Cancer With Resectable Liver Metastases

Patients with rectal cancer and resectable liver metastases receive short course radiotherapy(5Gy/f x 5f) to the pelvis and XELOX consolidating chemotherapy al least 4 cycles after 2 weeks.

Patients with rectal cancer and resectable liver metastases receive 25 Gy in 5 fractions of 5 Gy over 5 days to the pelvis and XELOX consolidating chemotherapy (with or without target therapy) al least 4 cycles after 2 weeks.

After evaluation, patients with resectable rectal cancer and liver metastasis will undergo surgery. Those patients with unresectable lesions will receive chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed primary carcinoma of the rectum (Lower border of tumour ≤ 10 cm from anal verge) locally advanced stage in primary site of rectum resectable synchronous liver metastases. The decision of resectable liver metastases will be made at multidisciplinary clinical meetings.

Exclusion Criteria:

* Obstruction of the gastrointestinal tract Previously constructed stoma prior radiotherapy of the pelvis
Coronary Artery Disease and Coronary Microvascular Disease in Cardiomyopathies Registry

Long-term prognostic value of macrovascular and microvascular coronary artery stenoses in each type of cardiomyopathy.

Coronary artery imaging techniques have taken a central role in the assessment of cardiovascular (CV) diagnosis over the past two decades. Many patients with a cardiomyopathy are also found to have a bystander coronary artery disease, not responsible for their cardiomyopathy. However, the prognostic value of those bystander coronary artery diseases is not known.

Also, new imaging techniques have been developed to assess coronary microvascular disease, but the prognostic value of these findings is not known.

In this study, the investigators evaluate the incidence and the prognosis of bystander coronary artery disease and microvascular disease in patients with ischemic, hypertrophic, dilated and restrictive cardiomyopathies in 5 French centers.

Coronary angiography, cardiac magnetic resonance (CMR), tomographic coronary artery angiography, single-photon emission computed tomography (SPECT), rest and stress trans-thoracic echocardiography (TTE) results will be recorded.

Macrovascular coronary artery disease is defined by :

* a stenosis \> 50 % in coronary angiography confirmed with myocardial ischemia (SPECT, stress echocardiography),
* a stenosis \> 70 % (50% if it is the left main coronary artery)
* or a stenosis 30-70 % with a fractional flow reserve (FFR) \< 0.8 Microvascular disease is defined by an index of microvascular resistance (IMR) \>23 or myocardial perfusion heterogeneity imaging (MPHI) \> 4 using SPECT or CMR.

Major adverse cardiovascular events (MACE) will be assessed 1 year, 2 years and 5 years after enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Ischemic
* Dilated
* Hypertrophic
* Restrictive cardiomyopathy.

Exclusion Criteria:

* Pregnant women
* Breastfeeding women
* Patients under legal protection
Improving Diabetes Care Collaboratively in the Community

The purpose of this study is to determine whether a quality improvement intervention including rapid quality improvement, a chronic care model, and best practices improves diabetes care in community health centers and whether more intensive interventions enhance care further.

In 1998 the Health Resources and Services Administration's Bureau of Primary Health Care began the Health Disparities Collaborative (HDC) to improve chronic disease management in community health centers (HC) nationwide. The HDC incorporates rapid quality improvement (QI), a chronic care model, and best practices. This study determines if the HDC improves diabetes care and whether more intensive interventions with additional learning sessions for health centers, provider training in behavioral change, and patient empowerment materials enhance care further.

Eligibility Criteria:
Inclusion Criteria:

- patients with diabetes age 18-75 years

Exclusion Criteria:

Pregnant women

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The Effect of Nonviolent Resistance in Parent Group Training in Child Psychiatric Care

In a Flemish sample of parents of children with psychiatric problems, this study evaluates the effect of a parent group training based on nonviolent resistance on family functioning, parenting variables and mental states of the parents, pre- and post-training.

Nonviolent Resistance (NVR) is an intervention method for families and teams that are suffering from helplessness and hopelessness. By empowering individuals through specific focus points and techniques, they can re-establish their role as authority figures for the child. The child, exhibiting dangerous and/or coercive behavior, can feel reconnected and guided.

Previous research has shown that parents score higher on General family functioning, Affective reactions and affective involvement, and Role definitions, but not Behavioral control, Problem solving and Communication. Positive effects were visible at a follow up moment, three months later. Parents reported significantly lower on anxiety for the aggression of their child, the self-efficiency about parental capacities and received social support. General parenting stress diminished significantly. A control group showed no such significant changes.

Participants with specific problems and waiting to be admitted in the residential ward at the study location can receive pre-care, in the form of a parental group training based on NVR. In six two weekly sessions, combined with intermediate telephone support and home assignments, parents are involved in important parent-child-oriented aspects.

This study will evaluate the effect of the training in a Flemish sample, focusing on family functioning, parenting variables and reflective functioning of the parents, pre- and post-training. T1 is at the time between invitation to participate and the first session; T2 is in the first week after the last session (T1 + 12 to 14 weeks); T3 is at three months after the last session; T4 is at six months after the last session.

The following primary outcomes are expected after the parent group:

* More behavior and mental states pointing towards NVR
* More use of adequate emotion regulation
* Less behavioral problems in the child

Secondary outcomes are expected, according to previous research measuring indirect effects of NVR treatment

* More adequate attunement to child
* More cohesion and structure in the family
* More adequate parenting behavior
* Less stress and burdening for parents

The investigators also expect parents with a more secure attachment style to benefit more (T2) and longer (T3 and T4) from the training.

Eligibility Criteria:
Inclusion Criteria:

Parents engage in the NVR training of the child psychiatric clinic at the study location for at least 5 out of 6 training sessions

Exclusion Criteria:

* insufficient understanding of Dutch/Flemish language
* simultaneously following a different parent group treatment, external to the study location
Landing Biomechanics Following Fatigue in Athletes With and Without a History of Patellar Tendinopathy

In this case-control study, two- and three-dimensional landing biomechanics, by means of lower limb joint angles and moments (opto-electronic system with synchronised force plate), will be compared between 30 male volleyball/basketball players with a history of patellar tendinopathy and 30 healthy controls.


Eligibility Criteria:
Inclusion Criteria:

* volleyball or basketball players
* male
* history of patellar tendinopathy

Exclusion Criteria:

* history of surgery of the lower extremities
* history of fractures of the lower extremities
HAT for the Treatment of Sepsis Associated With NASTI

Evaluate the impact of HAT therapy versus placebo in the treatment of patients with an acute NSTI and sepsis.

Primary outcome:

1. Hospital survival

Secondary outcomes:

1. Duration of vasopressor therapy
2. Requirement for renal replacement therapy in patients with Acute Kidney Injury (AKI)
3. ICU length of stay (LOS)
4. Change in serum procalcitonin (PCT) over first 72 hours
5. Change in SOFA score over first 72 hours (measured as SOFA score daily for four days, with day one being admission, then 3 days after, totaling 4 days of treatment with HAT)
6. Procalcitonin clearance (formula = initial PCT - 72 hour PCT divided by initial PCT x 100)
7. Number of wound related surgeries
8. Wound status at time of hospital discharge:

   1. Open
   2. Closed

Eligibility Criteria:
Inclusion Criteria:

1. Necrotizing soft tissue infection by clinical diagnosis and requiring surgical treatment.
2. Sepsis by clinical diagnosis and/or by Sepsis-3 criteria15, with source attributed to the wound.
3. Anticipated or confirmed intensive care unit

Exclusion Criteria: (Adapted from Sevransky et. al's VICTAS protocol)

1. Age \< 18 years of age
2. Weight \< 40 kg
3. Prior enrollment in this study or current enrollment in another study of any kind
4. Surgical findings, pathology/histology findings, or other findings determined to be inconsistent with an infectious acute NSTI such that the clinical diagnosis is no longer that of a NSTI
5. Sepsis deemed unlikely
6. Limitations of care during enrollment \[defined as refusal of cardiovascular and respiratory support modes described in inclusion criteria, including "do not intubate" (DNI) status and comfort care\]
7. Known allergy or known contraindication to vitamin C, thiamine, or corticosteroids \[including previous history or active diagnosis of primary hyperoxaluria and/or oxalate nephropathy, or known/suspected ethylene glycol ingestion, or known glucose-6-phosphate dehydrogenase (G6PD) deficiency\]
8. Use of vitamin C at a dose of \>1g/day (IV or oral) within the 24 hours preceding first episode of qualifying organ dysfunction during a given Emergency Department or Intensive Care Unit admission
9. Chronic disease/illness that, in the opinion of the site investigator, have an expected lifespan of \< 30 days unrelated to current sepsis diagnosis (e.g., stage IV malignancy, neurodegenerative disease, etc.)
10. Kidney Stone(s) of any kind
11. History of Oxalate Kidney Stone(s)
12. Pregnancy or known active breastfeeding
13. Prisoner or Incarceration
14. Inability or unwillingness of subject or legal surrogate/representative to give written informed consent
Adherence to Study Medication Compared to Generic Topical Clindamycin Plus Generic Topical Tretinoin in Subjects With Mild to Moderate Acne Vulgaris

The purpose of this research study is to evaluate the effectiveness of two different types of topical acne medication. This study will help to determine if one combined medication results in better acne improvement than two separate medications for acne.


Eligibility Criteria:
Inclusion Criteria:

* Males or Females 12 years of age or older with a diagnosis of mild to moderate acne vulgaris.
* Subjects must sign written informed consent and agree to come for all study visits.

Exclusion Criteria:

* Use of experimental drugs within 1 month prior to initiation of study therapy.
* Pregnant and nursing females will not be allowed in the study, and females of childbearing potential will have a pregnancy test at baseline. Females of childbearing potential must agree to use approved birth control methods for the duration of the study.
* Use of systemic retinoids within 2 months of enrollment, use of any topical retinoids, systemic antibiotics, nicotinamide, systemic steroids or any other medication that may confound the results of the study within 1 month prior to start of the study
* Use of any other topical medications for acne, including cosmetics containing retinol, within 2 weeks prior to study entry.
* Any skin condition or disease that may require concurrent therapy or may confound the evaluation;
* History of hypersensitivity to any of the formulation components;
* Facial skin cancer or facial actinic keratosis;
* Use of any photosensitizing agents.
* Use of isotretinoin within the last 6 months.
* Chemical peels, microdermabrasion or laser resurfacing within 3 months of study entry.
* Crohns disease, ulcerative colitis, or have developed colitis with past antibiotic use.
Comparison Between Letrozole and Mifepristone in Medical Termination of First Trimester Miscarriages

Prospective interventional study where participants with non-viable pregnancy at 1st trimester will be randomized into two arms, one group will receive conventional treatment with oral mifepristone followed by misoprostol vaginally and another group will receive letrozole for three consecutive days followed by misoprostol vaginally in an attempt to terminate the pregnancy medically. Mean duration of induction to expulsion of product of conception and rate of complete abortion will be compared in two groups.


Eligibility Criteria:
INCLUSION CRITERIA :

* Women older than 18years who will give consent regarding medical management of missed abortion
* First trimester pregnancy (gestational age less than equal to 12weeks) with missed abortion confirmed by ultrasonography
* Hemoglobin level more than 12mg/dl

EXCLUSION CRITERIA :

* Hemodynamically unstable patient
* Abnormalities in blood tests including complete blood count (CBC), prothrombin time(PT), internationalised normalized ratio(INR) and fibrinogen
* History or clinical evidence of any thromboembolic impairment or deep venous thrombosis
* Having intra-uterine device
* Present or previous use of corticosteroids
* History of any malignancy
* Existing cardiovascular disease contraindicating misoprostol
Percutaneous Trans-facet Screw Fixation Under CT-scan Guidance for Remaining Symptoms at a Distance of Previous Spinal Surgery

Background : Segmental spinal instability after a laminectomy, and adjacent segment disease (ASD) at after an arthrodesis, are well-known concerns in spinal surgery, which may require re-interventions, usually by surgical arthrodesis, posing the problem of a new heavy intervention under general anesthesia, in often fragile patients.

Trans-facet fixation (TFF) under local anesthesia and double fluoroscopic and CT guidance is a minimally invasive technique involving the placement of screws through the posterior facet joints, improving spinal stability.

Purpose : The aim of our study is to evaluate the efficacy, in terms of pain reduction (VAS) and improvement of daily activities (ODI), of TFF under CT scan guidance in the context of low back pain and/or radiculalgia related to focal instability secondary to laminectomy or ASD.

Methods : TFF were performed in 24 patients having a history of spinal surgery such as laminectomy and/or classic surgical arthrodesis and remaining symptomatic, at Nice University Hospital between 2017 and 2021 Pre- and postoperative pain and disability levels were measured using the visual analogue scale (VAS) and the Oswestry Disability Index (ODI), collected prospectively at systematic 6-month and 1-year follow-up visits. Long term evolution were assessed by phone consultation.


Eligibility Criteria:
Inclusion criterias : - Patients treated at Nice University Hospital between 2017 and 2021 by transfacet arthrodesis,

* History of spinal surgery ( laminectomy and/or classic arthrodesis) - Clinical signs of subsequent instability(low back pain and/or radiculopathy).
* MRI or scintigraphy signs of instability or ASD :
* Spondylolisthesis appeared or increased on successive exams
* Facet dislocation
* Subchondral bone changes of the vertebral endplates (Modic 1)
* Insufficient improvment after epidural and posterior joint corticosteroid infiltrations
Intrathecal Rituximab With Standard Intrathecal Prophylaxis to Prevent CNS Relapse for CD 20+ Non Hodgkin Lymphoma

The purpose of this research study is to learn if giving rituximab, the study drug, right into the spinal canal along with chemotherapy drugs like methotrexate is possible and safe.


Eligibility Criteria:
Inclusion Criteria:

* CD20 positive diffuse large b-cell lymphoma undergoing treatment with systemic rituximab in combination with CHOP, CHOEP, or EPOCH and deemed high risk of CNS relapse and eligible for central nervous system prophylaxis with intrathecal therapy.

Exclusion Criteria:

* Primary central nervous system lymphoma or established secondary central nervous system disease.
* History of spinal surgery and/or ineligible for intrathecal injections.