cyrilzakka/clinical-trials huggingface dataset:
Study Evaluating Long-Term Safety of Desvenlafaxine Succinate Sustained Release With Japanese Adult Subjects in Major Depressive Disorder (MDD)

The primary objective of this study is to evaluate the long-term safety of desvenlafaxine succinate sustained release tablets during 10-month open-label treatment of Japanese subjects with major depressive disorder (MDD).

The secondary objective is to evaluate the long-term response of subjects receiving desvenlafaxine succinate sustained release tablets by clinical global evaluation, general well-being and absence of symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients who have completed double-blind therapy in short-term study for the indication of major depressive disorder (MDD), including scheduled evaluations, with no major protocol violations and no study events that, in the opinion of the investigator, would preclude the subject's entry into the long-term, open-label study.

Exclusion Criteria:

* Clinically important abnormalities on baseline (day 56 of the short-term study) physical examination, or any unresolved clinically significant abnormalities on electrocardiogram (ECG), laboratory test results, or vital signs recorded before day 56 in the previous short-term study for the indication of MDD.
Efficacy and Safety of Indacaterol in Adults (40 Years and Above) With Chronic Obstructive Pulmonary Disease (COPD)

This study evaluated the efficacy and safety of two doses of indacaterol in adults aged 40 or over with chronic obstructive pulmonary disease (COPD) in China and in two other countries.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged ≥ 40 years
* Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate to severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007) and:

  1. Smoking history of at least 10 pack years
  2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) \< 80% and ≥ 30% of the predicted normal value
  3. Post-bronchodilator FEV1/FVC (forced vital capacity) \< 70%

Exclusion Criteria:

* Patients who have received systemic corticosteroids for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period
* Patients requiring long-term oxygen therapy (\> 15 hours a day) for chronic hypoxemia
* Patients who have had a respiratory tract infection within 6 weeks prior to screening
* Patients with concomitant pulmonary disease
* Patients with a history of asthma
* Patients with diabetes Type I or uncontrolled diabetes Type II
* Any patient with lung cancer or a history of lung cancer
* Any patient with active cancer or a history of cancer with less than 5 years disease-free survival time
* Patients with a history of long QT syndrome or whose QTc interval (Bazett's) measured at screening is prolonged
* Patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period
* Patients unable to successfully use a dry powder inhaler device or perform spirometry measurements

Other protocol-defined inclusion/exclusion criteria applied to the study.
Flow Regulation by Opening the Septum in Patients With Heart Failure Trial

To investigate the safety and efficacy of a novel atrial flow regulator (AFR) device in patients with heart failure and preserved ejection fraction.

The study will allow us to demonstrate the safety of the AFR device as well as determine the clinical response of the therapeutic intervention. In addition, the invasive exercise hemodynamics will provide objective data for the changes in the cardiac hemodynamics and delineate underlying mechanisms of creating a permanent inter atrial shunting.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Age \> 40 years
* LVEF \> 45% documented within the last 3 months.
* NYHA class ≥II status or 6MWT distance \<80% predicted.
* Left atrial enlargement
* PCWP ≥25 mmHg during supine bicycle exercise on hemodynamic monitoring.
* Left atrial pressure greater than right atrial pressure by ≥5 mmHg on hemodynamic monitoring.

Exclusion Criteria:

* Recent MI, PCI or CABG
* Untreated CAD with indication for revascularization
* Recent stroke, pulmonary embolism or major surgery
* Uncontrolled atrial fibrillation
* H/O cardiomyopathy (hypertrophic, restrictive, infiltrative) or pericardial disease
* Inability to perform a 6-minute walk test.
* Clinically significant valvular disease
* Uunsuitable for study participation at investigator discretion.
* Severe COPD, Anemia or morbid obesity
* Uncontrolled hypertension
* Women of child bearing age
* RA pressure \>15 mmHg or PVR \>4 wood units
Neurobiology of Eating Disorders Treatments

Background. Treatments of eating disorders result too often in partial psychological and physical remission, chronic course, dropout, relapse and death, with no fully known explanations for this failure. In order to clarify this problem, we conducted a three branches study to identify the biochemical background of cognitive-behavioral psychotherapy (CBT), individual psychology brief psychotherapy (IBPP), and psychotherapy-pharmacotherapy with CBT+olanzapine in anorexics (AN) and bulimics (BN) by measuring the levels of plasma homovanillic acid (HVA) for dopamine secretion, plasma 3-methoxy-4-hydroxy-phenylglycol (MHPG) for noradrenalin secretion, and platelet \[3 Hydrogen\]-Paroxetine-binding Bmax and Kd for serotonin transporter function. The data were then compared with psychopathological and physical alterations. Methods. Branch 1 investigated the effects of 4 months of CBT on plasma HVA, MHPG and \[3 Hydrogen\]-Par-binding in 14 AN-restricted, 14 AN-bingeing/purging, and 22 BN inpatients. Branch 2 investigated the effects of 4 months of IBPP on plasma HVA in 15 AN and 17 BN outpatients. Branch 3 investigated the effect of 3 months of CBT+olanzapine (5 mg/day) in 30 AN outpatients. The data are analyzed using one-way ANOVA for repeated measures for the changes between basal and post-treatment biological and psychological parameters, two-way ANOVA for repeated measures for the differences in the psychobiological data in the 3 groups, Spearman's test for the correlations between basal and final changes in the psychological and biological scores.


Eligibility Criteria:
Inclusion Criteria:

* eating disorders full diagnosis according to Diagnostic and Statistical Manual (DSM-IV)
* age between 15 and 35
* female gender

Exclusion Criteria:

* associated major psychiatric problems
* mental retardation
Efficacy and Safety of Lectranal® in Treatment of Seasonal Allergic Rhinitis Symptoms

The purpose of the study is to determine weather Lectranal is effective in treatment of seasonal allergic rhinitis symptoms.

Patients allergic to the specific pollen are divided into two groups randomly. One group is being administered Lectranal and the other group is being administered placebo during the period of 6 weeks in season of the pollen. Methods used for evaluation are: SARS questionnaire(seasonal allergic rhinitis symptoms), Mini RQLQ (mini rhinoconjunctivitis quality of life questionnaire) skin Prick test, specific IgE and IgG, eosinophilia in nasal secretion. Methods used for follow up safety include side effects report, physical examination and vital signs.

Eligibility Criteria:
Inclusion Criteria:

* history of seasonal allergic rhinitis symptoms to pollen
* positive skin prick test to pollen
* negative history of seasonal allergic asthma
* male or female older than 18
* female participants must use appropriate contraception
* able to comply to study procedures

Exclusion Criteria:

* pregnancy
* alcohol or drug abuse
* subject receiving antihistamines , immunotherapy or on hyposensibilisation
Cohort Study Evaluating Glycaemic Control in Individuals with Type 2 Diabetes Mellitus Through Digital Therapeutics (DM DTx)

This study is conducted to evaluate the effectiveness of Digital therapeutics (DTx) in managing patients with Type 2 Diabetes Mellitus (T2DM) by delivering digital lifestyle interventions through a national health application (BruHealth).

This study is a single-arm, non-randomised clinical trial designed to evaluate the effectiveness and feasibility of an online management approach to improve glycaemic control in individuals with Type 2 Diabetes Mellitus (T2DM) through a digital lifestyle intervention (named the BALANCE Programme) over a 16-week period. The intervention leverages the Diabetes Mellitus Digital Therapeutics (DM DTx) module within the BruHealth application. Additionally, a Healthcare Professional (HCP) portal is included to facilitate ongoing monitoring and support, ensuring personalized care and real-time interactions between participants and healthcare providers.

In addition, Muslim participants are offered the option of providing information in the DM DTx module about their fasting practices during Ramadan as an opportunistic way of obtaining data on the fasting risk and fasting experience in this cohort.

Primary Objective:

The primary objective is to assess the proportion of participants who experience a reduction in HbA1c levels by at least 0.6% by the end of the 16-week intervention period.

Secondary Objectives:

1. To evaluate the overall changes in HbA1c, fasting blood glucose, Body Mass Index (BMI), waist circumference and improvements in lipid profile components (such as cholesterol and triglycerides) at week 16, compared to baseline measurements;
2. To evaluate participants' feedback on their experience with the BALANCE Programme and its usability after 16 weeks of usage;
3. to evaluate fasting experience amongst Muslims with T2DM during Ramadhan and to calculate their fasting risk using IDF-DAR score.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 70 years
* Diagnosed with T2DM who are on any one or more of the following treatments:

  1. oral glucose lowering medication(s)
  2. any type of insulin treatment (up to 2 injections a day only)
  3. on diet control only
  4. GLP-1 receptor agonist established at least 6 months prior to enrolment

Exclusion Criteria:

* Diagnosed with T2DM on more than 2 insulin injections a day
* Diagnosed with Type 1 Diabetes Mellitus (T1DM)
* Pregnant / Breast-feeding
* Recent Myocardial Infarction (MI) or Stroke / Cerebrovascular Accidents (CVA) in the past 6 months
* Heart failure
* Liver failure
* Active cancer
* Undergoing active treatment for active foot disease
* Undergoing active treatment for active diabetes-related eye disease
* CKD stage 4 and 5 (eGFR \< 30ml/min)
* Hospitalisation for any reason in the past 6 months
* Advised by doctor to not participate in intense physical activity
* Physical disability and/or unable to perform Activities of Daily Living (ADL) independently
* Unable to use Youtube on mobile devices
* Unable to use BruHealth independently
Plant Protein Supplementation Within a Healthy Lifestyle Modulates Plasma Circulating Amino Acids and Improves the Health Status of Overweight Individuals

A dietary pattern based on Mediterranean diet has been reported as healthy for humans, as well as doing aerobic exercise regularly, diminishing the development of potential inflammation in subjects. Protein intake has been proposed as nutritional strategy to further improve these positives outcomes in terms of preventing inflammation diseases. In this work, overweight patients followed a Mediterranean diet together with aerobic exercise according to WHO-guidelines and were supplemented with 20 g of hemp protein/day, for twelve weeks.

Anthropometric and biochemical measures (including analysis of oligoelements), as well as plasma circulating amino acids were evaluated in each patient at the end of the intervention, to assess whether biologically relevant changes could be observed.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 65 years old
* waist circumference ≥94cm in men and ≥88cm in women
* MET\<4

Exclusion Criteria:

* prediabetic patients on pharmacotherapy
* subjects suffering from medical issues (e.g., diabetes or another chronic disease)
* smokers
* pregnant or lactating women.
Visualization of Inspiratory Effort and Respiratory Mechanics to Promote Lung- and Diaphragm Protective Ventilation

This is a multicentre prospective cohort trial in adult and pediatric ICU patients. The investigators will measure the effect of a patient's inspiratory effort during mechanical ventilation on the lungs and diaphragm. The investigators will daily (for a maximum of 8 days) measure esophageal pressures with a balloon catheter to quantify inspiratory effort and respiratory muscle function, and perform daily ultrasound measurements of the diaphragm and the lungs. The investigators hypothesize that a small inspiratory effort will result in the preservation of diaphragm function and have no adverse effect on lung function.


Eligibility Criteria:
Inclusion Criteria:

* age \> 28 days
* weight \> 3kg
* requiring invasive mechanical ventilation
* anticipated length of ventilation \> 48h

Exclusion Criteria:

* refusal of consent
* mechanical ventilation ≤ 2 weeks before inclusion
* known anatomical malformation of the diaphragm (including congenital diaphragmatic hernia)
* contra-indication to the placement of a naso-gastric esophageal balloon catheter
Treatment Uptake Chatbot for Eating Disorders

Eating disorders (EDs) are serious mental illnesses associated with high morbidity and mortality, clinical impairment, and comorbid psychopathology. Although evidence-based treatments for EDs have been established, the treatment gap is wide. Indeed, \<20% of individuals with EDs receive treatment. There is need for a novel solution not only to identify individuals with EDs but also to encourage mental health services use and to address treatment barriers. This study aims to implement a conversational agent or "chatbot" that is optimized to increase mental health services use among individuals with EDs through such features as: 1) education on the seriousness and consequences of EDs; 2) engaging the user in motivational interviewing to overcome barriers to care; 3) providing a personalized recommendation for seeking intervention; 4) repeated check-ins with the user to encourage follow-up with care. This study will utilize a randomized optimization trial with adults who have completed screening on the National Eating Disorders Association (NEDA) website and screen positive for an ED but are not in treatment to determine chatbot feasibility and to generate data on the effect of the chatbot on motivation for treatment and mental health services use. This trial will employ the Multiphase Optimization Strategy framework, using a 2\^4 full factorial design, to randomly assign participants to a combination of the four proposed intervention components (n=16 conditions) to isolate the active ingredients.


Eligibility Criteria:
Inclusion Criteria:

* U.S. resident
* English-speaking
* Age 18 years or older
* Owns a personal smartphone
* Screens positive for a Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) clinical or subclinical eating disorder
* Not currently receiving treatment for an eating disorder

Exclusion Criteria:

* Non-U.S. resident
* Younger than 18 years old
* Does not own a personal smartphone
* Does not screen positive for a DSM-5 clinical or subclinical eating disorder
* Screens positive for Avoidant Restrictive Food Intake Disorder
* Currently receiving treatment for an eating disorder
Efficacy and Safety Study of Intravenous to Oral Solithromycin (CEM-101) Compared to Intravenous to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia

This study will evaluate the safety and efficacy of an experimental antibiotic, solithromycin, in the treatment of adult patients with community-acquired pneumonia.

Community-acquired bacterial pneumonia (CABP) is an acute infection of the pulmonary parenchyma with symptoms such as fever or hypothermia, chills, rigors, chest pain, and/or dyspnea. The widespread emergence of antibiotic resistant pathogens, including the macrolide-resistant Streptococcus pneumoniae, has resulted in a need for new and effective antibiotics that have activity against CABP pathogens. Solithromycin is a fourth generation macrolide antibiotic with excellent activity against resistant S. pneumoniae and other key typical and atypical bacterial respiratory pathogens. A completed Phase 2 study showed comparable efficacy to levofloxacin in adults with CABP.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients ≥ 18 years of age
* An acute onset of at least 3 of the following signs and symptoms (new or worsening):

  1. Cough
  2. Production of purulent sputum
  3. Shortness of breath (dyspnea)
  4. Chest pain due to pneumonia
* At least 1 of the following:

  1. Fever
  2. Hypothermia
  3. Presence of pulmonary rales and/or evidence of pulmonary consolidation
* PORT Risk Class II, III, or IV
* Presence of lobar, multilobar, or patchy parenchymal infiltrate(s) consistent with acute bacterial pneumonia on a pulmonary imaging study
* Not received any systemic antibiotics during the prior 7 days

Exclusion Criteria:

* Ventilator-associated pneumonia
* Known anatomical or pathological bronchial obstruction or a history of bronchiectasis or documented severe chronic obstructive pulmonary disease
* Hospitalization within 90 days or residence in a long-term care facility within 30 days prior to the onset of symptoms
* Fungal pneumonia
* Pneumocystis jiroveci pneumonia
* Aspiration pneumonia
* Other non-infectious causes of pulmonary infiltrates
* Primary or metastatic lung cancer
* Cystic fibrosis
* Active or suspected tuberculosis
* HIV or myasthenia gravis
Neurogenic Mechanisms in Burning Mouth Syndrome

Burning mouth syndrome (BMS) is characterized by a bilateral burning sensation in the anterior tongue, hard palate and lips in the absence of any clinical or laboratory findings. The term syndrome implicates the simultaneous presence of oral dryness (xerostomia) and altered taste (dysgeusia) in addition to the burning sensation in the oral mucosa. BMS is most often seen in women and is more frequent during menopause. The etiology and pathogenesis are still unclear but recent studies suggest that BMS is a neuropathic pain condition.

The objectives of the study are:

* To clarify potential neurogenic mechanisms behind BMS using immunohistochemistry (IH) to characterize the localization and distribution of peripheral nerve fibres, neuropeptides like substance P, calcitonin gene-related peptide, nerve growth factor, nerve growth factor receptor, PGP 9.5 neuronal marker and TRPV1 as well as inflammatory/structural changes.
* To perform a randomized double blind cross-over intervention study to examine the efficacy and safety of topical application of capsaicin oral gel (on the tongue) to relieve the burning sensation in patients with BMS.

Data which support the hypothesis that BMS is a neuropathic pain condition include amongst others a recent clinically controlled study that has shown up-regulation of TRPV1-positive nerve fibres in tongue mucosa in patients with BMS. The vanilloid receptor-1 (TRPV1) is a voltage-dependent cation channel expressed by the unmyelinated C-nociceptive nerve fibres and the receptor may be activated by capsaicin (from chili peppers), heat and H+. Capsaicin binds to the TRPV1 receptor causing depolarization of the C-nociceptors. Prolonged activation of these neurons by capsaicin depletes pre-synaptic substance P and makes them unable to report pain.

Eligibility Criteria:
Inclusion Criteria:

* non-smoking female patients with burning mouth syndrome (n=26)
* healthy aged-matched control group (n=10)

Exclusion Criteria:

* pregnancy and lactation (inclusion requires negative pregnancy test)
* women who do not use safe anticonception
* patients with know allergy/hypersensitivity to capsicum and other capsaicinoid-containing products
* Active infection which requires antibiotic treatment
* use of mouthrinse. The use of these is stopped 14 days before inclusion
* patients who are able to give informed consent due to physical or mental disabilities
Restoration of Arm Function in People With High-level Tetraplegia

Functional electrical stimulation (FES) has been used to activate paralysed muscles and restore movement after spinal cord injury and stroke. This technology involves the application of low-level electrical currents to the nerves and muscles to cause muscle contraction where the user's ability to achieve that through voluntary means has been lost.

Providing control of muscle contraction in a coordinated way can mean that users are able once again to produce functional movements in otherwise paralysed limbs.

Routine clinical use is limited to the prevention of drop foot in the lower limb following stroke and occasional therapeutic use in the hand and shoulder. Systems providing functional reach and grasp, however, have not achieved clinical or commercial success. This project aims to develop methods for personalising assistive technology to restore arm function in people with high-level spinal cord injury. The investigators will use a combination of electrical stimulation to elicit forces in muscles no longer under voluntary control, and mobile arm supports to compensate for insufficient muscle force where necessary. The investigators will use computational models specific to an individual's functional limitations to produce patient-specific interventions. The project will be in three phases: building a model to predict the effects of electrical stimulation on a paralysed arm with arm support, development of methodologies using this model to optimise the arm support and stimulation system, and testing of stimulation controllers designed using this approach.


Eligibility Criteria:
Inclusion Criteria:

* Patients with mid- to high-level spinal cord injury resulting in partial or full paralysis of the upper limb will be eligible for inclusion in the study. In addition, they must be:
* Able to give informed consent;
* Able to remain comfortably seated with provision of trunk stability;
* Medically stable and at least six weeks from injury; and
* Have sufficient passive range of motion without discomfort.

Exclusion Criteria:

* Have orthopaedic implants across or between electrode sites;
* Have active cardiac implant;
* Have poor skin conditions, scar or carcinogenic tissue at site of stimulation;
* Have uncontrolled pain;
* Have uncontrolled epilepsy;
* Have skin reactions to electrodes;
* Have open wounds or injuries; and
* Are pregnant or planning for a pregnancy.