cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Oxymetazoline Added on Nasal Steroid in Rhinitis With Persistent Nasal Obstruction

Background Allergic rhinitis is a common health problem with a worldwide prevalence is 10-25%, and poses significant impact on the quality of life of the patients. In Thailand, the prevalence of allergic rhinitis in the general population is 13.5%, of which the frequency of allergic rhinitis increased from 23% to 38% in the children, and 61.9% in the graduate students. Despite intranasal steroid being the current first-line treatment of patients with allergic rhinitis, only 60% of patients achieve excellent control. Persistent nasal congestion is the major symptom which is difficult to control in these patients. Data are limited about efficacy and safety of the additional use of 0.05% intranasal oxymetazoline hydrochloride (OXY) for persistent nasal congestion that does not adequately respond to recommended doses of intranasal steroid (INS) and oral antihistamine(OAH).

Objective To determine the efficacy and safety of the additional use of OXY for persistent nasal congestion in allergic rhinitis or non-allergic rhinitis patients inadequately controlled by combination treatment with INS and OAH.

Methods The investigators performed a 6-week, randomized, double blind, placebo controlled, clinical trial in 50 patients with allergic rhinitis or non-allergic rhinitis whom inadequately controlled by combination treatment with INS and oral antihistamine (OAH). After an initial screening, qualified individuals were randomized into 2 groups including the treatment group and the control group. The treatment group received the INS (2 puffs in each nostril twice daily) and OAH (1 tablet once daily) plus OXY (2 puffs in each nostril twice daily) The control group received INS (2 puffs in each nostril twice daily) and OAH (1 tablet once daily) plus placebo (2 puffs in each nostril twice daily).

All participants will continue medications for 4 weeks, then stop using interventional medication and still take INS (2 puffs in each nostril twice daily) and OAH (1 tablet once daily) for 2 more weeks. Then, all participants will come for the last visit to see whether rebound nasal symptoms occur. Participants will be asked to record nasal symptom diary card, and nasal peak inspiratory flow. Rhinoconjunctivitis Quality of life Questionnaire (Rcq) will be recorded during visit.

Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years of age or greater
* Diagnosis with allergic or nonallergic rhinitis with persistent nasal obstruction
* Being treated with intranasal steroid and oral antihistamine

Exclusion Criteria:

* Underlying disease of hypertension
* Use oral or nasal decongestant 7 days prior to entering the study
* Nasal polyp or significant deviated nasal septum
* Respiratory tract infection 14 days prior to entering the study
Virtual World Health Behavior Counseling for Patients With Diabetes

Comparison of 2 methods of delivery health education for African-American women with Type 2 Diabetes. The two methods are: face to face education in small groups, as compared to delivering the same curriculum in the virtual world, Second Life.

This study will provide health education to African-American women with type 2 diabetes either face to face, or using the Internet. The study seeks to determine how feasible the internet method is for this type of health education, and how it compares to the face to face method. Patients will be recruited from Boston Medical Center. They will do baseline surveys and have blood drawn. They will then be randomized into receiving their diabetes education in a face to face group at BMC, or receiving it online while at home. The online group will receive a computer to access the Internet program and Internet access. Both groups will participate in 8 diabetes education groups, and 4 individual counseling sessions. Subjects will complete surveys before and after the study to measure changes in physical activity, diet, and use of medications, and will have blood tests drawn at BMC before and after the study to measure changes in diabetes control, cholesterol. They will also have blood pressure measured before and after the study period.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with T2DM
2. HbA1c level \>= 8.0
3. Currently treated with diet, oral hypoglycemics or insulin. If currently on insulin, must have a history of prior therapy with diet alone or oral hypoglycemic agents
4. African-American origin
5. \>= 18 years old
6. Telephone in home or easy access to one
7. Able to understand and participate in the study protocol
8. Functionally capable of meeting the activity goals
9. Understands and can provide informed consent
10. Physician approval to participate in the study.

Exclusion Criteria:

1. History of diabetic ketoacidosis
2. Gestational diabetes
3. Unable or unwilling to provide informed consent
4. Plans to move out of the area within the 12-month study period
5. Required intermittent glucocorticoid therapy within the past 3 months
6. Experienced an acute coronary event (myocardial infarction or unstable angina) within the previous 6 months
7. Has a medical condition that precludes adherence to study dietary recommendations (e.g., Crohn's disease, ulcerative colitis, end-stage renal disease)
8. Has a medical or psychiatric illness (i.e., dementia, psychiatric hospitalization or suicidality within past 5 years or takes an neuroleptic medication). We will not exclude based on history of depression or anxiety or taking anti-depressants or anti-anxiety medications.
NESA Microcurrents on Quality of Life in Geriatric Patients

In recent years, the population of older adults (MA) in the world has been increasing, due to the increase in life expectancy and the decrease in the fertility rate. The United Nations (UN) places Spain as the most aged country in the world in the year 2050, with 40% of its population over 60 years of age. There is evidence that quality of life in the elderly is associated with variables linked to physical and psychological health. Thus, for example, previous research indicates that perceived health and cognitive functioning influence the perception of quality of life.

The NESA XSIGNAL® device is a low-frequency, non-invasive neuromodulation device that uses microcurrents to restore electrical balance in the body. This technology is approved as medical equipment and is CE marked.

This non-invasive neuromodulation equipment is starting to have promising results in patients with sleep disorders. So it can be a useful tool to reduce the impact on the geriatric patient's quality of life.

The main objective will be to evaluate the efficacy of the application of non-invasive neuromodulation in the treatment of geriatric patients for the improvement of health-related quality of life. For this purpose, the investigators propose to carry out an interventional study with a sample of approximately 40 participants. Data will be recorded for 1 month and a half for each participant.

It is estimated 7 months from the design, management and development of the project, and it does not have sources of financing.

Eligibility Criteria:
Inclusion Criteria:

* Patients residing in the social-health care center under study.
* Stable medical and pharmacological condition.
* No cognitive impairment or mild cognitive impairment.

Exclusion Criteria:

* Patients with some of the contraindications for treatment with NESA device: pacemakers, internal bleeding, not applying electrodes on skin in poor condition, with ulcerations or wounds, acute febrile processes, acute thrombophlebitis and/or phobia of electricity,
* Not having signed the informed consent form.
* Patients with severe cognitive impairment, patients with severe cognitive impairment.
DNA/RNA Analysis of Blood and Skeletal Muscle in Patients Undergoing Cardiac Resynchronization Therapy (CRT)

Genes expressing inflammatory cytokines (TNF- alpha, IL1 etc) and genes involved in apoptosis (Caspase 3, Bax, Bcl-2, Fas) are dysregulated in the skeletal muscles of the patients who have muscle wasting and decreased exercise capacity with CHF.

Patients who show benefit from CRT may also show reversal of the inflammatory/apoptotic cascade that accompanies CHF and these patients may be the ones who benefit the most from CRT

1. The general objective of this study is to:

1. To identify the molecular pathways that may be altered in the blood and skeletal muscles of the patients undergoing CRT by using transcriptional analysis of the blood and skeletal muscle in these patients
2. To identify objective measurable molecular signals, using gene expression profiling, that correlate with clinical improvement in patients undergoing CRT.
3. To identify the molecular profile of patients who are most likely to benefit from CRT with improvement of exercise capacity and reversal of cardiac cachexia.
4. To identify biochemical pathways involved in cardiac cachexia.
5. To identify genes involved in positive remodeling and reversal of apoptotic cascade in the skeletal muscle.

Eligibility Criteria:
Inclusion Criteria:

* Patients with poor LV function and an EF of ≤35%
* Patients who are symptomatic with Class II or Class III heart failure on optimal medical therapy.
* Patients with EKG showing QRS duration of greater than 120 ms and meet criteria for Bi-ventricular ICD implantation.

Exclusion Criteria:

* Patients with other co-morbid conditions which could contribute to cachexia, such as end stage renal disease, ongoing malignancy, chronic or acute liver failure, age greater than 80yrs.
* Patients who are unable to walk and are wheelchair bound or need assistance to walk for reasons other than CHF.
* Patients with muscular dystrophies and myopathies.
* Patients with untreated hyper or hypothyroidism.
* Patients on Dialysis.
* Patients with recent (\<12 weeks) revascularization.
* Patients with recent (\<12 weeks) myocardial infarction.
Noninvasive Transcutaneous Glucometer Development

The objective of this study is to assist in the development of a noninvasive device for the accurate measurement of blood glucose levels.

The feasibility of measuring blood glucose concentration in patients with diabetes mellitus using near infrared (NIR) spectroscopy and multivariate data analysis techniques has been established using general purpose, scientific-grade infrared spectrophotometers under the 90-049 UNM HRRC protocol. Now that the concept of painless, bloodless, and reagent-less clinical laboratory tests has been shown to be viable, the challenge is to bring this technology to the patients who need it. We must develop a device that is portable, affordable, and rugged - all while improving accuracy. We must also improve our understanding of the nature of glucose in whole, intact skin. Since the light beam cannot discriminate plasma glucose in skin blood vessels from glucose in the larger skin interstitial fluid space, the exact nature of the glucose in all tissue compartments contributing to the light-beam signal must be elucidated. The noninvasive measurement can be no more accurate than the reference measurement on which it was based. Finally, we have found that the accuracy of the noninvasive measurement also worsens as a function of time from the initial measurement. This effect is independent of instrumentation drift and is due to physical changes in the patient's skin such as variation of hydration, collagen, vascularity, glycation end-products, etc. To account for these sources of physiologic interference they must be evaluated independently and then compared to errors of the noninvasive predictions over time.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Healthy
* Type I diabetics
* Type II diabetics
* Impaired glucose tolerance

Exclusion Criteria:

* Minor status (\<18 years of age)
* Pregnant
Efficacy and Safety of Intravenous Iron Sucrose in Patients With Hip Fracture to Prevent Perioperative Anemia

The purpose of this study is to evaluate the safety and efficacy of intravenous iron sucrose in patients with hip fracture and surgical intervention to prevent perioperative anemia.

The main objective of this study is to evaluate the safety and efficacy of intravenous iron sucrose in patients with hip fracture and surgical intervention to prevent perioperative anemia.

It will also determine whether intravenous iron sucrose administration improve outcomes as Haemoglobin values, transfusional needs, postoperative complications, length of hospital stay and cost-effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 65 years old
* With Hip fracture or peritrochanteric fracture.
* Who needs surgical intervention.
* And sign the informed consent form.

Exclusion Criteria:

* Tumor pathological fracture.
* Two or more long bone fractures.
* Seric Ferritin levels \> 300 ng/ml.
* Hypersensitivity to Iron sucrose or any component of the formulation.
* Patients with allogeneic transfusion rejection.
* Patients with previous blood transfusion request (Hb\< 8g/dl).
* Patients treated with hematopoietic growth factors.
* Patients with Anticoagulant treatment, due to thromboembolic high risk disease.
* Asthma in treatment.
* Cirrhosis, Acute Hepatitis, or increased Aminotransferases (\> 3 times the upper limit of normal).
* Advanced Dementia (GDS\>5) from the Global Deterioration Scale.
Operative Plate Fixation Versus Replacement for Mason Type III Fracture of Radial Head

To compare the effect of Operative Plate Fixation Versus Replacement for Mason Type III Fracture of Radial Head

From April 2015 to October 2016, patients with comminuted radial head fractures diagnosed as Mason type III are retrospectively included in this study, they were treated with either operative plate or radial head replacement. All the patients are regularly followed up in clinic. Then we will compare the union rate and clinical functional outcome(Mayo score) between the 2 groups at 1 year after surgery.

Eligibility Criteria:
Inclusion Criteria:

Men or women aged 18 to 65 years of age with Mason Type III radial head fracture are confirmed by radiograph within 1 month post injury Provision of informed consent

Exclusion Criteria:

Pathological fractures Non-displaced (cortical contact) fractures Open fractures Presence of vascular or nerve injury Fractures more than 1 month post-injury Limited life expectancy due to significant medical co-morbidity Medical contraindication to surgery Inability to comply with rehabilitation or form completion Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, patients not mentally competent to give consent, etc.)
Identification of Prognostic Factors and New Therapeutic Targets in Cutaneous Lymphomas

Cutaneous lymphomas are a heterogeneous group of extra-nodal lymphomas. The prognosis of cutaneous lymphomas is extremely variable from one subject to another. In the majority of cases, there is no cure for cutaneous lymphomas. Cutaneous lymphomas primarily affect the skin, and secondarily the blood, lymph nodes and possibly other organs. The discovery of new molecular prognostic factors will allow a better identification of patients at high risk of aggressive evolution and the implementation of a personalized therapeutic strategy. The identification of new therapeutic targets is necessary in order to develop new innovative treatments for cutaneous lymphomas.The primary objective is to identify novel molecular prognostic factors associated with 5-year overall survival in cutaneous lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 years old
* Informed consent signed by the patient
* Suspicion of primary cutaneous lymphoma or confirmed lymphoma according to WHO/ISCL/EORTC criteria

Exclusion Criteria:

* Patient under guardianship or curatorship
* Lack of affiliation to social security
RC48 Combined With EGFR or HER2 TKI for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations

Disitamab Vedotin（RC48）combined with EGFR or HER2 TKIs in locally advanced or metastatic NSCLC Patients with HER2 Alterations.

This study will explore the treatment of locally advanced or metastatic non-small cell lung cancer with HER2 mutation, amplification, or HER2 protein overexpression, using Disitamab Vedotin（RC48）combined with EGFR or HER2 TKIs, in the aim of providing new treatment strategies for lung cancer patients with HER2 pathway activation.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18 (inclusive) or above, regardless of gender.
2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC, not suitable for radical surgery or radiotherapy (TNM 8th Edition).".
3. HER2 alterations include HER2 gene mutations, gene amplification and HER2 protein over-expression;
4. Number of treatment lines:

   * Arm1: patients who have not previously received systemic treatment for advanced diseases;
   * Arm2: Previously received first line of third-generation EGFR-TKIs treatment with local progression, oligometastasis, or slow progression, and evaluated by the researchers to continue to benefit from third-generation EGFR-TKIs treatment;
   * Arm3: Previously received first line of third-generation EGFR-TKIs treatment with extensively progression, and evaluated by the researchers not likely to continue to benefit from third-generation EGFR-TKIs treatment;
5. There is at least one measurable lesion that meets the definition of the RECIST 1.1 standard at baseline.
6. ECOG fitness status score: 0 or 1 point.

Exclusion Criteria:

1. Central nervous system metastasis or meningeal metastasis with clinical symptoms.
2. Known hypersensitivity or intolerance to any component of the study protocol drug or its excipients.
3. Have a history of severe cardiovascular disease.
4. Have a history of interstitial lung disease or drug-induced interstitial lung disease requiring steroids treatment; radiation pneumonia.
5. Have a history of neurological disorders or mental illnesses, including epilepsy or dementia.
6. Pregnant or lactating women.
7. The researcher believes that the subject is not suitable to participate in this clinical study due to other reasons.
Efficacy, Safety and Tolerability of ACZ885 in Pediatric Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease

This trial will assess the safety, efficacy and tolerability of ACZ885 in patients aged 4 years and younger with cryopyrin associated periodic syndromes (CAPS)


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients that are 28 days up to 60 months of age at the time of the screening visit.
2. Body weight \> or = 2.5 kg.
3. Parent or legal guardian's written informed consent is required before any assessment is performed for patients.
4. At study entry, patients should have a clinical diagnosis of FCAS, MWS, or NOMID and symptoms requiring pharmacological intervention. Prior agreement between the Investigator and Novartis for study eligibility is required for patients who do not have a molecular diagnosis of NALP3 mutations available (either testing not performed, or testing performed but negative) upon study entry. For those patients who have not been molecularly tested for NALP3 mutations, molecular testing should be performed during the course of the study.
5. For patients treated with an IL-1 blocking agent (i.e. anakinra, rilonacept), these treatments should be discontinued prior to the baseline visit and patients must demonstrate active disease prior to treatment.
6. Patients who are scheduled to receive an immunization, according to their local vaccination guidelines, with an inactivated vaccine must be willing to participate in the assessment schedule for vaccinated patients.

Exclusion Criteria:

1. Preterm neonates for whom, in the Investigator's judgment, participation in the study is not deemed appropriate.
2. History of recurrent and/or evidence of active bacterial, fungal, or viral infections (including HIV).
3. Patients with immunodeficiency or treatment with immunosuppressive drugs.
4. Live vaccinations within \< or = 3 months prior to screening. No live vaccinations will be allowed throughout the course of this study and up to 3 months following the last dose.
5. Patients with an increased risk of tuberculosis (TB) infection according to following risk factors:

   * Patients with recent close contact with persons known to have active pulmonary TB disease
   * Foreign-born patients from countries with a high prevalence of tuberculosis
   * Patients with recent tuberculosis infection (including children \> 6 months with a positive PPD test \[defined as an induration of at least 10mm\])
   * Patients with end-stage renal disease
   * Patients with diabetes mellitus
   * Patients receiving immunosuppressive therapy
   * Patients with hematologic cancers.
6. Participation in another trial within the last 30 days or 5 half-lives of the investigational compound (whichever is longer).
7. Familial and social conditions rendering regular medical assessment not possible.
8. Pediatric patients with neutropenia (absolute neutrophil count \[ANC\] \< 1.5 x 10 to the 9th/l)

Other protocol defined inclusion/exclusion criteria may apply
Pilot Trial of Chlorhexidine Gluconate (CHG) Preoperative Skin Preparation

Pilot study to evaluate and compare activity of CHG preoperative preparation with comparator CHG

Evaluate and compare similar preoperative surgical preparations in healthy volunteers. Efficacy was assess using Tentative Final Monograph (TFM) criteria.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* No dermatological conditions

Exclusion Criteria:

* Sensitivity to CHG
* Sensitivity to natural latex rubber or adhesive skin products
Protein Supplementation and Exercise in Patients With FSH Muscular Dystrophy- a Randomized Placebo Controlled Study

The hypotheses is that regular post exercise supplementation increase fitness and daily activity level in patients with Fascioscapulohumeral (FSH) muscular dystrophy.

All patients are tested before and after 12 weeks of cycle-ergometer exercise. Maximal oxygen consumption and 6MWT is used as primarily effect goals. Secondary effect goals are risk of falls and daily activity level.

The purpose of this study is to investigate the response to protein-carbohydrate supplementation doing regular exercise in patients with FSHD. All patients are tested before and after 12 weeks of cycle-ergometer exercise. Maximal oxygen consumption and a functional 6 min walk test(6MWT) is used as primarily effect goals. Secondary effect goals are risk of falls and daily activity level. We measure manuel muscle strength, a balance test, a 5-time-up-and-down-chair-test, a 14 steps-stair-test, accelerometer measuring, daily activity level questionnaire and SP36.

We use a blinded randomized controlled trail. The interventions are 12 weeks regular exercise and consumption of a post-exercise drink. The exercise consists of 30 session of 30 minutes moderate exercise on a cycle-ergometer. After each exercise session patients consume a protein or a non-caloric placebo drink.

Eligibility Criteria:
Inclusion Criteria:

* Verified FSHD
* Age 18-65
* Untrained. Less than two hours cardio-training each week the last 4 month.

Exclusion Criteria:

* Competitive disorders
* Pregnant and breastfeeding
* Unable to walk 200 m within 6 min.