cyrilzakka/clinical-trials huggingface dataset:
Effects of High Intensity Focused Electromagnetic Therapy With Pelvic Floor Muscle Training on Urine Leakage and Quality of Life in Primipara or Multipara Women With Stress Urinary Incontinence

This study aimed to evaluate the impact of High-Intensity Focused Electromagnetic Therapy (HIFEM) combined with Pelvic Floor Muscle Training (PFMT) versus PFMT alone on urine leakage and quality of life in primiparous and multiparous women with stress urinary incontinence. Women aged 30 years or older exhibiting symptoms of stress urinary incontinence were randomized into two treatment groups. The experimental group received both HIFEM and PFMT, while the control group received only PFMT. The treatment continued for 6 weeks. Evaluations measured at baseline and post-intervention included the 1-hour Pad Test, the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF), and sonography to assess bladder neck movement.


Eligibility Criteria:
Inclusion Criteria:

* Primipara or Multipara women aged 30 years or older with symptoms of stress urinary incontinence;

Exclusion Criteria:

* Those who had any contraindication for High-Intensity-Focused-Electromagnetic-Therapy (HIFEM);
* prior surgery for incontinence;
* taking drugs for bladder dysfunction or diuretics;
* hormone therapy;
* urgent or mixed urinary incontinence;
* incontinence associated with a neurologic condition;
* inability to perform voluntary pelvic floor muscle contractions;
* cognitive impairment or dementia, major neurological disorders (such as stroke, cerebral palsy, multiple sclerosis);
* inability to carry out the treatment or evaluation;
* uncontrolled hypertension.
Improvement of Sleep Quality by RePneu® Coils in Advanced Pulmonary Emphysema

Improvement of sleep quality in emphysema patients is desirable. Yet, there are no data of patients treated with RePneu coils. This monocenter prospective study investigates the effect on sleep quality of RePneu coils for reduction of dynamic hyperinflation in advanced disease stages of pulmonary emphysema.

Patient's sleep will be studied in three Polysomnography measurement nights, one prior to Coil Treatment, one six months after, and one twelve month after.

Primary objective is to investigate differences in sleep quality 6 and 12 months after Coil Treatment.

Further endpoints are changes in daily activity and sleep (actigraphy), 6MWT, lung function parameters, and questionnaires (SGRQ, mMRC dyspnoe scale).


Eligibility Criteria:
Inclusion Criteria:

* Written consent
* RePneu Coil treatment according to clinical criteria

Exclusion Criteria:

* Pregnancy or nursing period
* Participation in another clinical trial within the last 4 weeks
* Incapable of giving consent
* Known OSA (AHI\>10)
Improving Symptoms and Quality of Life in Chronic Heart Failure: Pilot Study

The overall goal of this study is to evaluate the pilot implementation of two palliative care interventions in veterans with chronic heart failure at the Denver VA Medical Center. This is a study of behavioral and care strategy interventions and involves no investigational drugs or devices.

The investigators will examine the feasibility of two palliative care interventions designed to improve different facets of quality of life. Briefly, the two interventions are:

1. A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) that includes

   1. evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse;
   2. a 6-session structured psychosocial care protocol targeting depression and adjustment to illness, supplemented by informal (family) caregiver assessment and support, provided by a social worker or psychologist; and
   3. brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.
2. A psychospiritual intervention that is home-based, self-guided, and requires minimal resources. It will be delivered in written modular form via US Mail along with brief weekly telephone support.

The specific aims of the study are to:

1. Examine intervention feasibility and determine preliminary estimates of intervention effect

   1. Determine patient participation rates and cohort retention
   2. Conduct a preliminary assessment of outcomes by measuring pre-post changes in quality of life, depressive symptoms, health status, life meaning, and spirituality.
2. Obtain qualitative feedback from study participants, the persons providing the intervention, and providers/leaders in primary care, mental health, palliative care, chaplaincy, and hospital operations.

Eligibility Criteria:
Inclusion Criteria:

* eligible veterans from the Denver VAMC will have a prior primary discharge diagnosis of heart failure in the last year,
* be at least 18 years of age, able to read and understand English,
* have consistent access to a telephone
* at least one of the following:

  1. Kansas City Cardiomyopathy Questionnaire (KCCQ) score less than or equal to 60;
  2. a second hospitalization for with a primary discharge diagnosis of heart failure in the last year;
  3. taking at least 80 mg oral furosemide (or equivalent) daily in a single or divided dose for at least 2 weeks;
  4. BNP greater than or equal to 250 or NT-proBNP greater than or equal to 1000; or
  5. estimated creatinine clearance 30-80 mL/min.

Exclusion Criteria:

* previous diagnosis of dementia;
* active substance abuse, defined as an AUDIT-C score greater than 7, two positive responses on substance abuse screening questions, or medical records indicating active substance abuse or dependence;
* comorbid metastatic cancer, given the focus on heart failure palliative care;
* nursing home resident; and
* diagnosis of bipolar disorder or schizophrenia.
Comparative Efﬁcacy of Rebamipide Gargle And Benzydamine HCL Gargle in Prevention and Management of Chemo- and Radio-therapy-induced Oral Mucositis

evaluate preventive and therapeutic effects of Rebamipide gargle on reducing incidence of oral mucositis in comparison with benzydamine HCL mouthwash.

Oral mucositis is a common and potentially dangerous complication of anticancer treatment. Inflammation and ulcerations of the oral mucosa make swallowing and, thereby, eating and drinking, difficult or even impossible, leading to anorexia and weight loss(Araújo et al., 2018) .There is a serious risk of infections and even sepsis, particularly in immune-ompromised patients. OM is associated with severe pain, affects the quality of life, and often requires reduction or suspension of chemotherapy and/or radiotherapy, thereby decreasing the relative dose intensity, which may worsen prognosis (Shumsky et al., 2019).

Benzydamine hydrochloride is a widely used drug in dentistry , a non-steroidal anti-inflammatory drug, has shown topical anti-inflammatory, analgesic, anaesthetic and antimicrobial effects and is used to attenuate inflammatory conditions like radiation -induced oral mucositis or chemotherapy-induced oral mucositis (Nithin, et al.,2018). In addition to this, Benzydamine HCL is available on the Egyptian market and its price is economical .Rebamipide is a drug used for the treatment of gastritis and gastric ulcer. The mechanisms involved in the anti-ulcer and cytoprotective effects of rebamipide have been reported to include an effect on prostaglandin E2 synthesis via COX-2 expression (Udagawaet al ., 2003), up-regulation of growth factors and their receptors such as EGF and HGF ,induction of mucus secretion ,anti-free radical effects and inhibition of the production of inflammatory cytokines such as IL-1, IL-8, and TNF-α (Yasuda et al., 2011).

Different treatment options and drugs have been tested in OM, only some of which exhibited clinical relevance such as oral cryotherapy, keratinocyte growth factor and amino acids enriched diets. Therefore, there is a clear requirement for new approaches to the prevention and effective treatment of OM (Mallick, Benson, \& Rath, 2016)

In 2019 a meta-analysis performed by Akagi and his colleagues (Akagi et al., 2019) showed that gargling treatment with Rebamipide is superior to placebo for the development of mucositis and stomatitis due to chemo-radio-therapy, especially for severe cases of Grade 3 or higher. However, in order to confirm these trials, further well-designed analyses are needed, and evaluation of adverse events in observational studies are also required.

Eligibility Criteria:
Inclusion Criteria:Male and female patients with head and neck cancer and who will be prescribed radiotherapy at least 60 Gy (Roopashri et al., 2011).

* Patients who will sign an informed consent,
* Patients older than 18 years of age,
* Patients having normal renal and liver functions

Exclusion Criteria:• . Use of dentures, or having any source of infection in the mouth.

* Allergy to rebamipide or benzydamine hydrochloride(Nithin et al., 2018) .
Multi-centre Study of HTL0018318 in Patients as an add-on to Standard-of-care

Multi-centre study of HTL0018318 in patients with Alzheimer's disease as an add-on to standard-of-care

This is a multi-centre study conducted in four countries. A total of 60 subjects with Alzheimer's disease who are on standard-of-care will be enrolled to receive one of 3 active HTL0018318 or placebo for a period of four weeks

Eligibility Criteria:
Inclusion Criteria:

1. Diagnostic evidence of Alzheimer's disease according to the 2011 National Institutes of Aging-Alzheimer's Association (NIA-AA) criteria
2. Participants with Alzheimer's disease on stable standard of care

Exclusion Criteria:

1. Presence of illness apart from Alzheimer's disease that could contribute to cognitive dysfunction
2. A current or history of clinically significant suicidal ideation within the past 6 months
3. Subjects who have been on anti-cholinergic and/or anti muscarinic treatment
Prospective Assay for SARS-CoV-2 (COVID-19) Antibody Detection Indirectly by Immunofluorescence: SARS-CoV2 IIF Method

Prospective assay for SARS-CoV-2 antibody detection indirectly by immunofluorescence: SARS-CoV2 IIF method

Sample preparation, serum separation by centrifugation

* 100 µl of serum for standard SARS-CoV2 ELISA is used according to the instructions for use.
* 100 µl of serum indirect immunofluorescent (IIF) method is used, the samples thus prepared analysis is performed under an automated microscope

Eligibility Criteria:
Inclusion Criteria:

* Person over 18 years of age
* Signing a package leaflet and a informal consent
* In the case of a positive group, confirmed by SARS-CoV2 qPCR Patient with COVID-19 or recovered individual.
* In case of negative group by SARS-CoV2 qPCR test 2 negative in COVID-19 suffering individual

Exclusion Criteria:

* Refuses to sign the consent form
Immunogenicity and Safety of an Inactivated Split-virion 2009 Pandemic Influenza A H1N1 Vaccine in Infants

The aim of this study is to investigate the immunogenicity and safety of the inactivated split-virion vaccine in infants.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy infants aged between 6 and 35 months
2. full-term birth with birth weight above 2,500 grams
3. Subject and parent/legal representative should be present at all scheduled visits and to obey all trial procedures

Exclusion Criteria:

1. Volunteers in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
2. Volunteers allergic to ingredient of vaccine composition (can be checked from vaccination history), especially to egg
3. History of progressive or severe neurologic disorder
4. Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
5. Known or suspected impairment/alteration of immune function, for example receiving immunosuppressive therapy or receiving blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation
6. Asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids
7. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
8. History of thyroidectomy or thyroid disease that required medication within the past 12 months
9. Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years
10. Guillain-Barre Syndrome
11. Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C
12. Any other vaccines or immunoglobulin preparation within 1 weeks prior to enrollment
13. Axillary temperature ≥ 38.0 degrees Celsius within 3 days of intended study vaccination
14. Any conditions may influence the evaluation
Effect of Peppermint Water on Breast Crack

To evaluate the effectiveness of a topical preparation of peppermint water in comparison with that of expressed breast milk for the prevention of nipple cracks in primiparous breastfeeding women.

One hundred and ninety-six primipara participants, who are breastfeeding after delivery at 38 or more week gestation, were assigned randomly to 2 groups, with one of 2 regimens (peppermint water, an old household remedy, and no treatment only using breast milk) to right and left sides. Each group was followed for a maximum of 3 visits within 14 days and until the 6 weeks postpartum by telephone call. The aerial parts of Mentha piperita were purchased from Hakim Momen Tabrizi Company, and the identity was confirmed by morphological characterization in comparison with the herbarium specimen retained in the School of Pharmacy, Tabriz University of Medical Sciences. Also, a voucher specimen has been generated in that herbarium.

Eligibility Criteria:
Inclusion Criteria:

* New mothers with healthy term infants (38 weeks gestation or more) are eligible for recruitment into the study. The sample of breastfeeding mothers were collected in two cohorts according delivery type. Each group consisted of 98 primipara mothers.

Exclusion Criteria:

* Mothers who didn't plan to use peppermint water
* Discharged before an interview or had preterm delivery
* Postpartum fever
* Breast infection
* Nipple abnormalities
* Age less than 18 years
* Twins
* Taking medications at night
* Mothers who didn't have telephone line, and who were illiterate.
* Infants who used bottle-feeding or pacifier, or who had mouth infection, or an abnormal short frenulum.
Nebulized Bronchodilators and Cardiac Repolarization

Patients of the ICU's often require bronchodilatory treatment due to bronchospasm caused by conditions like : acute respiratory distress syndrome (ARDS), chronic obstructive pulmonary disease (COPD) or asthma. The β2 adrenergic drugs are one of the most commonly used for this purpose. However it is known that they may cause tachycardia and may have substantial proarrhythmic effect. The investigators' aim is to estimate the influence of nebulized bronchodilatory drugs on selected electrophysiological parameters, whose changes are generally recognized as potentially increasing the risk of ventricular and supraventricular arrhythmias. Two drugs will be compared - salbutamol given in two doses and ipratropium bromide

50 mechanically ventilated patients above 18 years of age and with presence of clinical features of bronchospasm requiring treatment with nebulised short-acting beta-2 mimetic.

Participants will be randomly allocated into two equal groups: a group that was to receive the dose of 2.5 mg and a group that was to receive the dose of 5 mg of nebulised salbutamol. The duration of nebulisation will be set for 20 minutes and Holter ECG data are to be recorded for 60 minutes from the initiation of the nebuliser. The acquired Holter ECG data will be analysed at 10 time points: before salbutamol administration and 5, 10, 15, 20, 25, 30, 40, 50, and 60 minutes following initiation of nebulisation. Changes in QT interval, corrected QT intervals calculated using Bazett's correction and the Framingham formula and transmural dispersion of repolarization TDR will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* the necessity of b2 adrenergics an m2 mimetics administration

Exclusion Criteria:

* patients with past medical history of ventricular arrhythmias ( ventricular tachycardia, ventricular fibril, Torsade de pointes)
* patients with persistent atrial fibrillation
* patients with abnormal plasma sodium, potassium, magnesium, and ionized calcium concentration
The E-health Application To Modify ORal Energy Intake and Measure Outcomes REmotely in ALS Clinical Trial (EAT MORE2)

This is phase IIa feasibility and tolerability study of a mobile health (mHealth) application designed to study the effects of remote dietary counseling on disease progression and quality of life. The study will consist of two phases: Part I will consist of building and beta-testing the ALS Nutrition app and Part II will consist of enrolling a larger cohort of users into the app.

The investigators' prior work has shown that nutrition is an important modifiable prognostic factor for ALS disease progression and survival. In the recently completed E-Health Application To Measure Outcomes Remotely (EAT MORE) clinical trial (sponsored by the ALS Association), the investigators found that nutritional counseling supported by a mobile health (mHealth) app was associated with 0.5 points/month slower ALSFRS-R progression (p=0.17) and improved quality of life (p=0.09).

The investigators are now designing an ALS-specific app that can be used by everyone with ALS, including those who do not live near ALS Centers. The app would help to address gaps in the delivery of ALS care by providing nutritional counseling, helping patients to manage and track their disease symptoms, and communicating with their providers. After the initial design has been tested by a group of NEALS patients and their caregivers, the study will advertise the app widely to recruit a larger group of ALS patients to measure nutrition and outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Participants with a diagnosis of ALS (self-reported)
2. Male or female subjects aged 18 years or older.
3. Participants must be capable of providing informed consent and complying with trial procedures.
4. Participants must have access to an iOS or Android device to allow the to download the apps.

Exclusion criteria:

1. Use of a feeding tube (G-tube or J-tube)
2. BMI\>30 kg/m2 regardless of weight loss history
3. A history of cardiovascular disease (stroke, myocardial infarction, peripheral vascular disease)
4. A history of diabetes (self-reported)
A Phase II Study of Belinostat in Combination With Bortezomib in Patients With Relapsed, Refractory Multiple Myeloma

This open-label study will assess anti-tumor activity and safety of belinostat in combination with bortezomib (Velcade®) in multiple myeloma patients refractory to or relapsed from at least one prior bortezomib-containing regimen. Subjects will be administered both PXD101 and bortezomib on the same days: i.e. days 1, 4, 8, and 11 of a 3-week cycle, for up to 8 cycles.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of multiple myeloma.
* Status of refractory to or relapsed from at least one prior bortezomib-containing regimen.
* Progressive disease.
* Age \>= 18 years.
* Karnofsky performance status \>= 60%
* Acceptable liver function:

  * Bilirubin =\< 1.5 x ULN (upper limit of normal)
  * Aspartate transaminase (AST) and alanine transaminase (ALT) =\< 3 x ULN
* Acceptable hematologic status:

  * Absolute Neutrophil Count (ANC) \>= 1.5 x 109/L
  * Platelet count \>= 100 x 109/L
  * Hemoglobin \>= 9 g/dL
  * Coagulation status PT-INR/PTT =\< 1.5 x ULN or in the therapeutic range if on anticoagulation therapy. (PT-INR/PTT= prothrombin - international normalized ratio / prothrombin time)
  * Serum potassium within normal range.
* Estimated life expectancy greater than 3 months.
* Signed, written IRB (institutional Review Board)-approved informed consent.

Exclusion Criteria:

* Non-secretory multiple myeloma or symptomatic amyloidosis.
* Hypersensitivity to bortezomib, boron, or mannitol.
* Less than 4 weeks since prior chemotherapy, radiotherapy, endocrine therapy, or immunotherapy, except if disease is rapidly progressing.
* Less than 4 weeks since prior use of other investigational agents.
* Serious concomitant systemic disorders (e.g. active infection).
* Significant cardiovascular disease.
* Marked baseline prolongation of QT/QTc (corrected QT interval)interval.
* Central nervous system disorders requiring neuroleptics / anti-convulsants.
* Peripheral sensory neuropathy of ≥ Grade 2
* Renal insufficiency defined as a creatinine clearance of \< 30 ml/min.
* Non-willingness to use effective contraceptive methods for patients of child-bearing age / potential.
* Pregnant or breast-feeding women.
* Known HIV positivity.
* Prior treatment with belinostat (PXD101), or any other HDAC (histone deacetylase) inhibitor.
* Altered mental status which precludes an understanding of the Informed Consent Document.
Elastography for Evaluating Cervical Maturity in Preparation for Labor Induction at 37 to 42 Weeks of Gestation

The primary objective of this study is to determine if a cervical hardness score (determined by cervical ultrasound with elastography) can predict delivery mode (vaginal versus cesarian for slow dilatation (more than 2-3h without fetal suffering) regardless of the induction mode (ocytocin alone or with an intravaginal device releasing PGE2).

The secondary objectives of this study are:

A. To determine composite criteria (combining elastographic, parity and Bishop score information) that predict delivery mode.

B. To determine the prognostic value of elastography as concerns delivery within 24 hours among patients induced via oxytocin with an intravaginal device releasing PGE2 (Bishop score \< 6).

C. To determine the prognostic value of elastography as concerns delivery mode (vaginal versus cesarian for slow dilatation (more than 2-3h without fetal suffering))among patients induced via oxytocin alone.

D. To evaluate the intra- and inter-operator reproducibility of the cervical hardness score determined via elastography.

E. To evaluate the economic impact of using the cervical hardness score from the point of view of the French social system (French health insurance) and the hospital.

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* Pregnant woman with a medical indication for pre-term labor induction: 37 to 42 weeks of gestation.

Exclusion Criteria:

* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* History of cervical surgery
* Malformation of the cervix