cyrilzakka/clinical-trials huggingface dataset:
Inhaled Nebulized Furosemide & Physical Activity-Related Breathlessness

Breathlessness on exertion is a common and troublesome complaint of individuals with restrictive lung disorders. In these adults, breathlessness contributes to physical activity-limitation and avoidance and an adverse health-related quality-of-life, often in a self-perpetuating cycle. It follows that alleviating dyspnea and improving exercise tolerance are among the principal goals in the management of adults with restrictive lung disorders. Nevertheless, effective management of breathlessness and physical activity-limitation remains an elusive goal for many healthcare providers and current therapies (e.g., antifibrotic agents, oxygen, exercise training) are only partially successful in this regard. Thus, research aimed at identifying breathlessness-specific medications to complement existing therapies for the management of physical activity-related breathlessness in restrictive lung disorders is timely and both clinically and physiologically relevant. The purpose of this randomized crossover study study is to examine the acute effects of two doses of inhaled nebulized furosemide (a loop diuretic) on the perception of breathlessness during laboratory-based cycle exercise in healthy, young men in the presence of an external thoracic restriction to mimic a 'mild' restrictive lung deficit. To this end, the investigators will compare the effects of inhaled 0.9% saline placebo and inhaled furosemide (40 mg and 120 mg) on detailed assessments of breathlessness (sensory intensity and affective responses) and its physiological determinants (ventilation, breathing pattern, dynamic operating lung volumes, cardio-metabolic function) symptom-limited, high-intensity, constant-work-rate cycle exercise testing with external thoracic restriction sufficient to mimic a 'mild' restrictive pulmonary deficit in healthy, men aged 18-40 years.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Aged 18-40 years
* FEV1 ≥80% predicted
* FEV1/FVC \>70%

Exclusion Criteria:

* Current or ex-smoker
* Body Mass Index \<18.5 or \>30 kg/m2
* Self-reported history of cardiovascular, vascular, respiratory, renal, liver, musculoskeletal, endocrine, neuromuscular and/or metabolic disease/dysfunction
* Taking doctor prescribed medications
* Allergy to sulfa medications
Immunomodulation With Romiplostim in Young Adults With ITP

The study aims to investigate immunomodulatory effects of thrombopoietin-receptor Agonist (TPO-RA) in patients with primary ITP, who failed first-line therapy or who became intolerant to it. It is hypothesized that the early phase of this autoimmune disease may exhibit a stronger immunomodulatory potential in response to a stimulus, such as romiplostim. Such a process may subsequently be capable to induce regulatory mechanisms or tolerance.

Romiplostim (a thrombopoietin-receptor agonist, TPO-RA) will be administered subcutaneously once weekly over 22 weeks with a starting dose of 1mcg/kg body weight. The dose will be adjusted based on platelet counts as described in the summary of Product Characteristics (SmPC).


Eligibility Criteria:
Inclusion Criteria:

* Informed consent as documented by signature (see informed consent form)
* Primary ITP according to the definition of Rodeghiero et al. (52) and a platelet count of \<30x109/l
* Age range: 18-45 years
* Previously treated patients, with failure or intolerance to first-line therapy, or relapse after first-line therapy, i.e. corticosteroids, intravenous immunoglobulin (IVIG), or anti-D immunoglobulins

Exclusion Criteria:

* Adults older than 45 and children younger than 18 years
* Platelet count higher than 30x109/l at time of screening
* Suspicion of secondary ITP
* Positive family history for ITP
* Presence or history of autoimmune disease as judged by the investigator
* Hepatosplenomegaly
* Presence or history of relevant hepatic disease as judged by the investigator
* Presence or history of thromboembolic disease as judged by the investigator
* Patients with splenectomy
* Women who are pregnant or breast feeding
* Intention to become pregnant during the course of the study
* Lack of safe double contraception (see 7.1)
* Any vaccination 2 weeks prior start of the study
* Drugs with a known impact on the immune system or on platelet function must be recorded and an exclusion of the study should be discussed with the study center
* Known or suspected non-compliance, drug or alcohol abuse
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia of the study subject
* Participation in another study with investigational drug within the 30 days preceding and during the present study
* Previous enrolment into the current study
* Previous treatment with romiplostim or eltrombopag
* Hypersensitivity to the active substance or to any of the excipients or to E. coli derived proteins
* Enrolment of the investigator, his/her family members, employees and other dependent persons
Indices of Severity and Prognosis for Sickle Cell Disease

To develop a clinical severity index that could prospectively identify sickle cell disease patients who were at high risk for a turbulent clinical course and a poor prognosis.

DESIGN NARRATIVE:

Using the database, univariate analysis showed that factors associated with the occurrence of cerebrovascular accident (51 patients) included hematocrit, rate of change of pocked red cell count, and polymer fraction at 40 percent oxygen saturation (PF40). Only low hematocrit was predictive of death in the pediatric cohort. There were 45 disease-related deaths.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Effect of Inadequate Bowel Preparation on Urgent Colonoscopy in Patients With PPB.

The purpose of this study was to explore the effect of abbreviated bowel preparation on repeated colonoscopy in patients with PPB.


Eligibility Criteria:
Inclusion Criteria:

patients with bleeding after polypectomy patients treated with colonoscopy within 24 hours after bleeding patients who did not receive adequate bowel preparation (oral laxatives).

Exclusion Criteria:

patients whose main outcome indicators were not clearly described patients whose baseline characteristics were missing.
Functional Assessment of the Patient With Fibromyalgia and Its Relation to Health: Fibromyalgia and Sarcopenia

Fibromyalgia is a chronic syndrome that causes fatigue, sleep disorders and generalized chronic pain in different parts of the body. This pathology is more prevalent in women and is generally not attributed to any specific cause.

This observational study aims to describe some important and health-related factors in patients with fibromyalgia.

Participants will have to fill out questionnaires related to sleep, anxiety, impact of the disease and sarcopenia index, and will then take tests related to grip strength for the upper limbs and dynamometry in the lower limbs. We will also employ the use of ultrasound to evaluate architectural measurements. Last but not least, we cannot forget the pain measurements that are so necessary in this study population.

Through the present research study we intend to analyze not only the health status of our sample but also to correlate the parameters analyzed with factors related to sarcopenia.

Through the data collection that will be carried out we can analyze variables as essential as pain, anxiety and depression, impact of the disease, agility, strength, anthropometric measurements, sleep and muscular architectural measurements by means of ultrasound in which we can analyze the fatty infiltration of structures such as the vastus lateralis, rectus anterior and vastus medius that allow us to obtain data that can define the characteristics of patients with fibromyalgia.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with FM
* aged between 18 and 75 years
* agree to participate and sign the informed consent.

Exclusion Criteria:

* who do not have recent surgeries
* patients with reduced mobility
* adequate level of comprehension to be able to answer the questionnaires that will be provided in the study.
Effect of Remote Ischemic Preconditioning on Cognitive Function After Cardiac Surgery

The purpose of this study is to evaluate the effects of Remote Ischemic Preconditioning on cognitive function in patients undergoing cardiac surgery compared to control intervention.


Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing heart surgery on cardiopulmonary bypass

Exclusion Criteria:

* Emergency cases
* Myocardial infarction up to 7 days prior to enrollment
* Stroke up to 2 months prior to enrollment
* Ejection fraction less than 30%
* Previous psychiatric and neurological illness
* Inability to give informed consent
The Effect of Phone Application Supported Nutrition Education on Weight Loss

Internet-based applications are potential supporters for individuals in weight loss programs due to their accessibility and wide access. These applications are aimed at changing the lifestyle of individuals.

This study is a randomized controlled study aiming to evaluate the effect of phone application supported nutrition education on weight loss according to standard education. It has been assumed that the telephone application would increase the adaptation and motivation of the people on diet. Anthropometric measurements and nutritional features of individuals, Weight Efficacy Lifestyle (WEL test), Quality of Life SF-36, Rosenberg Self-Esteem, Obese Individuals Specific Quality of Life, Healthy Life Style Behaviour Scale-II and Healthy Eating Index score changes questioned as intermediate variables. Between March and September 2018, 79 people aged between 18-64 years, whose BMI was 25 and more, who were admitted to the dietitian at Ege University Faculty of Medicine Hospital Endocrine and Metabolic Diseases Clinic and received routine nutrition education were included in the study. In the first interview, the data collection form of all individuals was filled out and anthropometric measurements of all individuals were made by the researcher. All individuals received a classic nutrition education by the clinical dietician and then written personal weight loss diets. Afterwards, only a control appointment for 3 months later was given to the control group. Phone application named Motive designed by the researcher uploaded to only case group's phone. With the telephone application text, visual and video notifications were sent to case group for 3 months.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index is 25 or more.
* Capable of filling the data collection form
* No visual-hearing problems
* Having a smart phone
* Having a internet connection
* Individuals who agreed to participate in the study and whose written consent was obtained

Exclusion Criteria:

* Not having smart phone
* Not having a internet connection
* Those who have undergone bariatric surgery
* Pregnancy
* Thyroid patients that using drugs
* Individuals who require a special diet other than obesity treatment (celiac, gout, diabetes, kidney diseases, coumadin users, etc., diagnosed by a doctor)
Real-Time Continuous Glucose Monitoring (RT-CGM) in Patients With Type 1 Diabetes at High Risk for Low Glucose Values Using Multiple Daily Injections (MDI) in Germany (HYPODE-STUDY)

Demonstrate that usage of RT-CGM (Real time continuous glucose monitoring) reduces the frequency of low CGM-recorded glucose events in patients using MDI (Multiple daily injections) that are at risk for hypoglycemic events.

In a randomized controlled trial the primary hypothesis is tested if the usage of RT-CGM in the intervention group (CGM group) reduces the frequency of glucose values \<55 mg/dl in patients with hypoglycemia problems (hypoglycemia unawareness or documented previous severe hypoglycemia) significantly more than in the control group receiving usual care (without CGM).

Secondary is tested if patients in the CGM group showed a significantly more favorable change in the below defined secondary endpoint than patients in the control group after 26 weeks follow up.

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 1 diabetes for at least 12 months on multiple daily injections (MDI). MDI is defined as prandial insulin injections at each major meal (excludes pre-mixed insulin) with doses determined by SMBG and carbohydrate counting, and basal insulin injection(s)
* Age ≥ 18 years
* HbA1c ≤ 9.0 % performed within 4 months before begin of the study
* High risk for severe hypoglycemia (defined as a score of 4 or higher on the Hypoglycemia unawareness scale (HUS) or a history of at least one severe hypoglycemic event in the last 12 months (required third part assistance, not able to treat themselves))
* Willing to not use paracetamol or drugs containing it
* Signed and dated Informed Consent Form

Exclusion Criteria:

* Use of personal real-time-CGM 3 months prior to study entry and during the study (except study devices)
* Use of a flash-glucose monitoring system 3 months prior to study and during the study
* Alcoholism or drug abuse
* Unable to comply with the protocol at the investigators discretion, such as known psychiatric diagnosis, cognitive / physical decline
* Pregnancy or lactation period
* Severe known allergies, e.g. against plaster
* Mental incapacity or language barriers precluding adequate compliance with the study procedures
* Limited or no legal capacity or legal guardianship
* Dependency from the sponsor or the clinical investigator (e.g. co-workers of the sponsor or the clinical research center or their families)
* Participation in another study at the same time with a non-approved drug or a non-CE-labelled medical device.
Evaluation of a Mixed Bowel Prep (2L PEG + Bisacodyl) Versus PEG With Ascorbate

It is hypothesized that PEG 2L with citrate and simeticone plus bisacodyl will have similar bowel cleansing efficacy versus PEG 2L with ascorbate. Safety, tolerability, acceptance and compliance of the two reduced volume PEG-based bowel preparation will be also compared.


Eligibility Criteria:
Inclusion Criteria:

* Out-patients undergoing a complete colonoscopy
* Patient written informed consent

Exclusion Criteria:

* Pregnant or lactating women or at a risk of becoming pregnant
* Hypersensitivity to any of the ingredients
* History of anaphylaxis to drugs or allergic reactions in general
* Known or suspected gastrointestinal obstruction or perforation
* Toxic megacolon; major colonic resection
* Heart failure (Class III or IV); severe renal failure; relevant diseases, that may interfere with the aim of the study
* Phenylketonuria;Glucose-6-phosphate dehydrogenase deficiency
* Unwillingness to co-operate and to comply with the requirements of the trial
Study of Gene Polymorphisms Involved in the Metabolism and Action of Vitamin D in Amyotrophic Lateral Sclerosis

This is a case-control study performed on a biological collection. The polymorphisms present on a pre-defined list of genes will be studied for 400 Amyotrophic Lateral Sclerosis (sporadic type) DNA samples and 400 control DNA samples.


Eligibility Criteria:
Inclusion Criteria:

* The primary inclusion criterium is the same for that of the parent biological collection, i.e. the patients fulfill requirements for probable or definite Amyotrophic Lateral Sclerosis as defined by revised international criteria (Brooks et al 2000).
* Additionally, included patients were followed-up by doctors at the University Hospital of Montpellier, thus enabling verification of Amyotrophic Lateral Sclerosis criteria over time.

Exclusion Criteria:

* The patient has a familial form of Amyotrophic Lateral Sclerosis (autosomic dominant or recessive types) with or without a mutation of one of the 3 genes known to be responsible for familial forms (SOD1, TARDBP, FUS). See Bender (1998).
Safety and Effectiveness of Sonu for Pediatric Nasal Congestion

To demonstrate the safety and effectiveness of Sonu for the treatment of pediatric patients with moderate to severe nasal congestion.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric subjects between the ages of 12 to 21 years
* Present with symptoms of nasal congestion for 1 month or more prior to treatment
* Have a 24 hour reflective nasal congestion subscore of the TNSS of 2 or more on a 0 to 3 scale at the time of screening

Exclusion Criteria:

* Head, nasal or sinus surgery within 3 months
* Sinus infection diagnosed within the last month, or rhinitis medicamentosa
* Documented history of nasal polyposis or mass
* Pregnancy
Fetal Loss in Women With Unprovoked Thromboembolism (FLUTE)

The purpose of this study is to determine the risk of fetal loss in women with unprovoked venous thromboembolism (VTE) who do not have identifiable inherited thrombophilia compared with women who have the diagnosis of venous thromboembolism (VTE) excluded.


Eligibility Criteria:
Inclusion Criteria:

* Female
* At least 18 years of age
* Symptomatic for unprovoked venous thromboembolism (deep vein thrombosis \[DVT\] or pulmonary embolism \[PE\])
* At least one pregnancy not terminated intentionally

Exclusion Criteria:

* Previous VTE in patients with current VTE excluded
Prediction of Cognitive Properties of Memantine for Neurodegenerative Diseases

The early assessment of new drugs for Alzheimer's disease remains difficult because of the lack of predictive end-point. The use of a battery including different parameters could improve this early development of new drugs. Nevertheless, the interest of such a battery should previously be validated with the yet marketed AD drugs.

The aim of the present study is to test the effect of a 15-day treatment with memantine on a mixed battery associating cognitive assessment, imaging and neurophysiological tests in healthy volunteers.

This multicenter, randomized, placebo-controlled, cross-over study is double-blind controlled and is conducted in 3 centers located in France (Lille, Marseille and Toulouse).

18-30 years old, healthy volunteers, without any neurological or psychiatric impairment, will complete 2 test sessions in a randomized order: one with a 15-day treatment with memantine, the other with placebo, and will be submitted to a mixed battery during the 14th and 15th day of the treatment. The primary outcome of the study will be based on cognitive assessment, imaging parameters and neurophysiological parameters

Eligibility Criteria:
Inclusion Criteria:

* 18-30 year old male non-smoker subjects
* Subject without cognitive impairment or cognitive complaint (Moca\>26, Mac Nair scale\<15)
* Subject without history of brain disease (severe brain trauma, stroke, cerebral tumor,...)
* Subject without major medical or surgical history
* Subject without current chronic disease
* Subject without current cerebral disease
* Subject without vascular or metabolic risk factor
* Subject without history or current mental disease or addiction (MINI)
* Subject without lesion on MRI
* Subject without abnormal electrical activities on EEG
* Subject without use of chronic treatment or psychotropic drugs or substances
* French speaker subject and able to understand the test instructions

Exclusion Criteria:

* Subject with dementia or cognitive decline identified by Moca \< 26
* Subject with vascular or metabolic risk factor
* Subject with history or current mental disease or addiction
* Subject with family history of young-onset dementia
* Subject with family history of chronic or severe neurological or mental disease (first degree relatives)
* Subject receiving a chronic treatment
* Subject with claustrophobia or contra-indication to MRI
* Subject unable to understand the test instructions
Trial of Xyrem® (Sodium Oxybate) for the Treatment of Narcolepsy

This is a long-term, open-label, extension of the OMC-SXB-7 trial. Participants from the OMC-SXB-7 open-label trial may be entered without any requirement as to length of participation in that trial.

Approximately 70 patients are expected to participate at up to 6 investigative centers located in Canada. The trial will continue for up to 24 months or until marketing approval, whichever occurs sooner.

This trial will be conducted as a long-term, open-label, extension of the OMC-SXB-7 trial. Participants from the OMC-SXB-7 open-label trial may be entered without any requirement as to length of participation in that trial.

Approximately 70 patients are expected to participate at up to 6 investigative centers located in Canada. The trial will continue for up to 24 months or until marketing approval, whichever occurs sooner.

Eligibility Criteria:
Inclusion Criteria:

* Remained on satisfactory treatment with Xyrem® therapy in the OMC-SXB-7 trial
* Signed and dated an informed consent
A Study to Assess Analgesic Efficacy of Intravenous Lignocaine

The primary objectives of this study are to analyse the effect of perioperative systemic infusion of lignocaine on postoperative pain, postoperative nausea and vomiting and perioperative levels of inflammatory mediators in patients undergoing elective open abdominal surgeries.

The secondary parameters which will be observed during the study are the time to passage of flatus and stools postoperatively.

Patients will be randomized into two groups- A and B, to receive an intravenous infusion of lignocaine or saline,respectively, as a bolus of 1.5mg/kg at the time of intubation followed by an infusion at a rate of 1.5mg/kg/hr continued throughout the surgery and till one hour postop. Postoperative analgesia will be provided through Patient Controlled Analgesia (PCA) pump providing morphine. Postoperative pain scores will be noted at immediate postoperative and at 6, 18, 24 hours post surgery. The number of PCA demands and cumulative morphine consumption till 24 hours post surgery will be noted. The incidence of postoperative nausea and vomiting is recorded. The time to first passage of flatus and stools postoperatively will be noted. Levels of total leukocyte count, c-reactive protein (CRP) and interleukin-6(IL-6) will be noted in preoperative, immediate post operative and 24 hours post surgery.

Eligibility Criteria:
Inclusion Criteria:

* patients above 18 years of age
* undergoing elective open abdominal surgeries
* belonging to the American Society of Anaesthesiologists (ASA)status I,II,III

Exclusion Criteria:

* patients sensitive to lignocaine,
* patients suffering from cardiovascular diseases or with preoperative changes on electrocardiogram
* patients on beta blocker drugs
* patients on opioid drugs for prolonged period
* patients with functional bowel disorders