cyrilzakka/clinical-trials huggingface dataset:
Change on Sleep Quality of Patients With Fibromyalgia Subjected to a Protocol Based on Physical Exercise and Stretching

This study evaluates the effect to a muscle stretching program combined with physical exercise versus a physical exercise program in patients with fibromyalgia.

Although classically this pathology was characterized by having an unknown etiology, current research suggests that the disease shows several abnormalities in the central pain processing.

Central sensitization is defined as changes in neuroplasticity of central nervous system as a result of persistent and intense sensory information nociceptive generated by peripheral and transmitted to the neurons in the dorsal horn of the cord through the nerves of the peripheral nervous system tissues, through a constant activity of C fibers and A-beta fibers.

In recent years the theory that pain is responsible for other symptoms, is changing, and it is theorized that the quality of sleep directly influences in the symptoms.

The treatment of fibromyalgia is based on trying to reduce pain and associated symptoms described above in order to improve the quality of life of these patients. Almost all revisions studying the effects of physical activity in fibromyalgia agree that it is effective in reducing the overall impact on the disease and its symptoms.

Muscle strength training aim to improve the strength, endurance and muscle power. There are few conclusive studies on the benefits of stretching and flexibility exercises on the impact of fibromyalgia.

Eligibility Criteria:
Inclusion Criteria:

* Be 18 years or more.
* To be diagnosed with fibromyalgia according to the criteria established by the "American College of Rheumatology", either on the basis of its publication of 1990 or the current revision of 2010.
* Accept to volunteer and give oral consent. Before starting the intervention must be provided written informed consent.

Exclusion Criteria:

* Do not present any pathology in which physical exercise is contraindicated.
* Do not suffer another serious somatic illness or severe psychological disorder. Not suffer severe dementia (MMSE \<10).
* Do not be participating at the time of the study in any other intervention of physical or psychological.
Efficacy of Adjunctive Low-Level Light Therapy to Intense Pulsed Light for Meibomian Gland Dysfunction

The goal of this clinical trial is to compare the effectiveness of adjunctive low-level light therapy (LLLT) to intense pulsed light (IPL) versus intense pulsed light (IPL) alone for the treatment of meibomian gland dysfunction (MGD).

The main question it aims to answer is does the adjunctive of low-level light therapy (LLLT) to intense pulsed light (IPL) provide more beneficial treatment effects than intense pulsed light (IPL) alone in treating meibomian gland dysfunction (MGD) patients?

Participants will be randomized into 2 groups: adjunctive low-level light therapy (LLLT) to intense pulsed light (IPL) group (ALLLT +IPL) and IPL alone group.

In both the IPL group and the ALLLT+IPL group, the doctor will administer IPL therapy to each participant and apply the Light Modulation® special facial mask to their faces. The assistant nurse will activate the light power, ensuring that the doctor remains blind to treatment allocation. Participants in both groups will receive a conventional treatment for MGD including warm compression and lid hygiene. Moreover, all participants will be advised to use preservative-free artificial tears 4 times daily throughout the study.

Eligibility Criteria:
Inclusion criteria:

* MGD severity level 2 and above according to the international workshop on MGD
* Fitzpatrick skin type of 1-4 according to sun sensitivity characteristics and appearance of the skin color

Exclusion Criteria:

* History of previous ocular trauma or surgery within the past six months
* Contact lens-wearing patients
* Patients with skin-pigmented lesions in the treatment area
* Pregnancy or breastfeeding patients
* Patients with any uncontrolled ocular or systemic diseases
Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Abdominoplasty

The primary objective is to evaluate the analgesic efficacy of intravenous (IV) oliceridine administered as needed (PRN) compared with placebo in patients with moderate to severe acute pain after abdominoplasty.


Eligibility Criteria:
Inclusion Criteria:

* Has undergone abdominoplasty with no additional collateral procedures.
* Experiences a pain intensity rating of moderate to severe acute pain.
* Able to provide written informed consent before any study procedure.

Exclusion Criteria:

* ASA Physical Status Classification System classification of P3 or worse.
* Has surgical or post-surgical complications.
* Has clinically significant medical conditions or history of such conditions that may interfere with the interpretation of efficacy, safety, or tolerability data obtained in the trial, or may interfere with the absorption, distribution, metabolism, or excretion of drugs.
* Has previously participated in another TRV130 clinical study.
Effect of I/R Injuries by Pringle Manoeuvre on the Prognosis of HCC Patients After Curative Hepatectomy

This is a multi-centre prospective randomized controlled trial to explore the influence of ischemia-reperfusion injuries elicited by pringle manoeuvre during radical excision on the prognosis of Hepatocellular Carcinoma (HCC) patients.

Until now there are two popular procedures during the radical excision of primary liver cancer in our country.One is to give a pringle manoeuvre to control the operative blood loss,the other is using a combination of CUSA and Tissue-link to control the bleeding while without liver ischemia.According to the recent experimental studies in rats,we know that the ischemia and reperfusion injury may contribute to the metastasis of the tumor.In order to test the actual contribution of ischemia on human,we conduct this prospective clinical trial to compare the two popular procedures' effect on the prognosis of liver cancer patients undergoing radical excision.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of resectable primary liver cancer
* The liver function showed:Child-Pugh A，ICG-R15 \< 20%
* HbsAg (+)
* tumor nodes in the liver were singular or multiple and could be radical excision
* No preoperative anti-cancer therapy
* Written informed consent from the patient or legal guardian prior to entering the study

Exclusion Criteria:

* Pregnancy patients
* With extrahepatic tumor or lymphnode metastasis
* Tumor invasion or thrombosis in portal vein,hepatic vein or inferior vena cava
* Positive marginal
The Effect of Abdominal Aortic Aneurysm Screening on Mortality in Asian Population

Abdominal aortic aneurysm(AAA) occurs when the infrarenal aorta expands to a maximal diameter of 3.0cm or greater. Although AAA may asymptomatic for many years, almost one third eventually rupture if left untreated.

Several randomized trials showed that ultrasonographic screening for AAA could reduce the frequency of acute operations and AAA-related mortality.

However, all of randomized trials were performed in Western countries. There was no randomized trials for AAA screening in Asian countries.

This randomized, controlled trial is to analyze the benefits of screening old population for AAA in Korea.

Old population, aged from 60 to 85 years, are randomized into two groups; one group is invited for ultrasonographic screening for AAA, and the other acts as age- and sex-matched controls.

For screening group, The anterioposterior and transverse diameter of the infrarenal aorta is measured at their maximal sizes. The subsequent surveillance of screened patients is done as follows

* Aortic diameter less than 3.0cm, no further testing
* AAA 3 to 4cm, ultrasonographic follow-up every year
* AAA 4 to 5cm, ultrasonographic follow-up every 6 months
* AAA greater than 5cm, referral to a vascular surgeon

For control group, the information for any causes of death is collected every year.

Eligibility Criteria:
Inclusion Criteria:

* all men aged 60 to 85 years
* women aged 60 to 85 years with cardiovascular risk factors such as hypertension, hyperlipidemia, peripheral arterial occlusive disease, coronary artery disease, cerebrovascular attack.
* men and women older than 50 years with a family history of AAA

Exclusion Criteria:

* people who was diagnosed with AAA
* people who underwent aneurysm repair such as open aneurysm repair or endovascular aneurysm repair
* People who underwent abdominal aortic surgery such as aortobifemoral bypass
* People whose life expectancy is less than 2 years
* People who appear unfit for repair of AAA
* people who do not agree with this study
Symbicort Usage in Asthma Treatment and Impact of a New Therapeutic Strategy on Compliance and Asthma Control in France

Descriptive pharmacoepidemiological study on the use of Symbicort Turbuhaler in the treatment of asthma in France and impact of a new therapeutic strategy on the compliance and control of asthma


Eligibility Criteria:
Inclusion Criteria:

* Asthmatic patients treated for this disease with Symbicort Turbuhaler
* Patients monitored for asthma by the doctor for at least 12 months
* Patients seen in outpatient care at the baseline visit
* Patients agreeing to participate in the study

Exclusion Criteria:

* Patients with any chronic lower respiratory disease other than asthma
* Patients receiving anti-IgE agents in the last 4 months
* Patients receiving desensitisation treatment outside of the maintenance phase
* Patients deemed to be unable to respond to the study for linguistic or cognitive reasons
Safety and Efficacy of CDB-2914 for Emergency Contraception

The purpose of this study is to assess the safety and efficacy of CDB-2914 for preventing pregnancy when taken 3 to 5 days after unprotected sexual intercourse.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or more
* Menstruating women with regular menstrual cycle between 24 and 35 days and intra-individual variations less than or equal to 5 days
* Request emergency contraception between 48 hours and 120 hours after unprotected intercourse as defined by lack of contraceptive use, or condom breakage (including condoms lubricated with spermicide) or other barrier contraceptive method failure
* No current use of hormonal contraception and having had at least one complete menstrual cycle (2 menses) since having stopped hormonal contraception
* For women with a recent history of Depo Provera use, the most recent injection must have been at least 9 months before study entry and followed by at least one complete menstrual cycle (2 menses)
* Willing to not use hormonal methods of contraception until study completion
* At least one complete menstrual cycle (2 menses) post delivery, miscarriage or abortion
* Able to provide informed consent in English
* Give voluntary, written informed consent, and agree to observe all study requirements (the subject needs to be available for follow-up over the next 6 weeks)
* Willing to abstain from further acts of unprotected intercourse during participation in the study and until pregnancy status has been ascertained

Exclusion Criteria:

* One or more acts of one unprotected intercourse more than 120 hours before requesting emergency contraception in the current cycle
* All acts of unprotected intercourse (in the current cycle) within 48 hours of presentation
* Currently pregnant as confirmed by positive HSUP test performed at screening
* Currently breast-feeding
* Current use of hormonal contraception
* Use of hormonal emergency contraception since last menstrual period
* Current use of IUD
* Tubal ligation
* Partner with a vasectomy
* Unsure about the date of the last menstrual period
* Severe asthma insufficiently controlled by oral glucocorticoid
* Currently enrolled in any other trial of an investigational medicine
Pegfilgrastim in Patients With Alcoholic Hepatitis

This is a multi-center, prospective, randomized trial of standard of care vs. standard of care + pegfilgrastim (Neulasta®) among patients with a clinical diagnosis of alcoholic hepatitis and DF≥32.

Standard of care treatment will be with either prednisolone 40 mg/day for 28 days or pentoxifylline 400 mg TID for 28 days. The patient's physician will decide the standard of care treatment the patient will receive. Patients will be randomized (1:1) to receive either no additional drug treatment (SOC group) or to receive a pegfilgrastim (Neulasta®, 6 mg) SQ.

Patients will be seen in-person at screening, randomization (Day 1), Day 8, Day 29, Week 12, and Week 24. Safety examination and blood tests will be performed. In addition, biological specimens will be saved for research purposes at these time points.

Total duration of patient participation is 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of alcoholic hepatitis with Maddrey's discriminant function score ≥32. Age 18 years or older.

Exclusion Criteria:

* Renal failure (creatinine \>2.0 mg/dl)
* Bilirubin \<5 mg/dL
* uncontrolled recent upper gastrointestinal bleeding
* Known HIV infection
* Uncontrolled infection, or pregnant.
SUNOSI® (Solriamfetol) Pregnancy Registry

The SUNOSI (solriamfetol) Pregnancy Registry is a prospective, multi-country, observational study to evaluate the safety of solriamfetol exposure during pregnancy in women with a diagnosis of narcolepsy or obstructive sleep apnea (OSA).

The goal of the registry is to provide information on the safety of solriamfetol during pregnancy so that patients and physicians can weigh the benefits and risks of exposure during pregnancy and make informed treatment decisions.

The study collects health information from enrolled pregnant women and their healthcare providers related to their pregnancies and developing babies up to 1 year of age. The registry is strictly observational. Only data that are routinely documented in patients' medical records during the course of usual care will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women of any age
* Diagnosed with narcolepsy or obstructive sleep apnea OR has taken solriamfetol or other wake promoting medications or stimulants during pregnancy
* Resident of a country where solriamfetol is available for the treatment of excessive daytime sleepiness (EDS) associated with narcolepsy or OSA
* Provides written informed consent to participate in the study
* Authorization for her HCP(s) to provide data to the registry

Exclusion Criteria:

* Occurrence of pregnancy outcome prior to first contact with the registry coordination center (RCC)
* Inclusion of a prior pregnancy in the main analysis population
Study of the Role of Tissular Maternofetal Alloimmunization in Placentation Pathologies

Justification:

We have recently demonstrated that maternofetal alloimmunization was not limited to blood cells: maternal alloimmunization against a glomerular podocyte antigen expressed by the placenta can induce neonatal membranous glomerulonephritis.

Early recurrent pregnancy losses, preeclampsia and intervillositis are obstetrical pathologies which share an anomaly of placentation. Pathophysiology of these diseases is not yet fully understood; nevertheless the hypothesis of an incompatibility between mother and child is often mentioned. The aim of this project is to detect and study the cases of recurrent pregnancy losses, preeclamspia and intervillositis which could be induced by tissular maternofetal alloimmunization.

Materials and methods:

Patients suffering from recurrent pregnancy losses of unknown origin, preeclamspia or intervillositis will be included in this project. Mothers' sera will be studied by indirect immunofluorescence and Western Blot on placental biopsies from different origins and gestational ages. This stage will enable us to detect possible maternal allo-antibodies. After detecting and revealing antibodies, nature of the target antigen will be identified by immunoprecipitation of placental extracts, using the positive sera. Immunoprecipitation will be followed by a mass spectrometry analysis of detected proteins.

Expected results:

This study will enable us:

* to detect new cases of tissular maternofetal alloimmunization
* to improve our knowledge of mechanisms leading to anomalies of placentation
* to carry out a specific, preventive therapeutic approach for cases induced by tissular alloimmunization.

Key words:

Recurrent pregnancy losses, Preeclampsia, Intervillositis, maternofetal alloimmunization.


Eligibility Criteria:
Inclusion Criteria:

* Recurrent pregnancy losses : patient having or having suffered from at least 3 consecutive, unexplained recurrent pregnancy losses, during the first 3 months of pregnancy, with the same paerson/man.
* Preeclampsia : blood pressure \> 140/90 mm Hg ; proteinuria \> 0,3 g/ 24 h
* Intervillositis : patient suffering or having suffered from intervillositis

Exclusion Criteria:

* Recurrent pregnancy losses : uterine pathology, endocrine pathology, autoimmune pathology, coagulation and hemostasis pathology, karyotype anomaly.
* Preeclampsia : pre-existing high blood pressure, pre-existing diabetes, pre-existing renal disease, antiphospholipid antibodies syndrome
* Intervillositis : intervillositis with villositis
Using the Subglottic Pressure to Predict the Dysphagia After Partial Laryngectomy

Recruited patients are divided into two arms depending on laryngeal carcinoma's T1 and T2 stages. Two interventions were undergone, including transoral endoscopic laser cordectomy and open partial horizontal laryngectomy (OPHL). During the pre-and post-operative time, patients performed measurements of swallowing function, including direct subglottic pressure, Eating Assessment Tool-10(EAT-10) questionnaire, swallowing ability to different textures, and fiberoptic evaluation of swallowing(FEES). Patients undergo subglottic pressure measurement and swallowing function evaluation three times: 3-7 days, two months, and six months after surgery. Patients also performed measurement voice acoustic analysis and subjective assessment one-day pre-operation and six months post-operation.

There were swallowing disorders after partial laryngectomy in most patients with laryngeal carcinoma. At least these patients need several months to recover. Few people required surgery of total laryngectomy to maintain normal swallowing function. The swallowing training cannot acquire a valid swallowing function and take the risk of aspiration pneumonia. Factors that influenced the swallowing function recovery, for example, the time of nasogastric feeding and tracheostomy tube removal, were affected by age and diabetes.

On the other hand, the pharynx size of a CT scan can predict the recovery of swallowing function after laryngectomy. But those are not directly related to swallowing motion, although they are predictors of dysphagia. The investigators will perform the study with swallowing function measures to find predictors relative to swallowing function and evaluate dysphagia's recovery early.

Subglottic pressure is a protective factor that can reduce aspiration risk. This research will measure the subglottic pressure after laryngectomy and predict or monitor swallowing disorders. Specific objectives were to verify the effect of laryngectomy on subglottic pressure.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-80 years
* Surgical treatment by open partial horizontal laryngectomy type I or II and transoral laser cordectomy for squamous cell carcinoma
* Availability of clinical data
* Validity of normal swallowing of thin liquids

Exclusion Criteria:

* Presence of severe chronic obstructive pulmonary disease, severe heart disease, and psychopathy or mental disease
* Surgery complications(such as sepsis, pharyngocutaneous fistula, surgical revision)
* Radiotherapy histology
* Swallowing disorder or trachea aspiration before surgery.
A Study to Determine the Feasibility of Wireless Electrocardiography

The investigators are conducting a prospective, observational study to examine the ECG waveforms captured by the new medical device as compared to a traditional Holter monitor for subsequent use in visual diagnoses of atrial and ventricular arrhythmias as well as cardiac impulse and/or conduction disorders by qualified clinicians.

The hypothesis is that this new medical device prototype is non-inferior to traditional Holter monitoring for capturing ECG waveforms that can be visually assessed for atrial and ventricular arrhythmias as well as disorders of cardiac impulse formation and/or conduction.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be at least 18 years of age
* Patients must have a medical indication to wear a Holter monitor
* Patients must not be pregnant
* Patients must be able to comply with the study procedures
* Patients must be willing to participate and able to provide informed consent
* Patients must be willing to wear both devices (Holter and the wireless device prototype) simultaneously and continuously for a 2 to 3 hr period

Exclusion Criteria:

* Patients who are not able or willing to comply with study procedures
* Patients with an existing implanted cardioverter-defibrillator and/or pacemaker
* Patients with a known life threatening arrhythmia
* Patients who manifest low voltage on their electrocardiogram
* Patients affected by inflammatory and/or infectious skin disorders
A Prospective Real World Evidence Study (PROWES) for Concordance Rate of Blood-based 3D Genome Conformation Mapping (Episwitch CiRT®) to Identify Likelihood of Response and Actual Response Rates to PD-(L)-1 Checkpoint Inhibitors Across Multiple Oncological Indications.

The purpose of this research is to test whether a blood-based 3D genome conformation mapping test called the Episwitch CiRT® can help to identify likelihood of response to PD-(L)-1 checkpoint inhibitors (a class of cancer drugs) across multiple oncological indications by comparing the results to actual treatment responses for cancer patients.

The Episwitch CiRT® (Checkpoint inhibitor Response Test) predicts how a patient will respond to immune checkpoint inhibitor (ICI) therapies by delivering a binary response likelihood profile (High Probability vs. Low Probability).

Patients who have been diagnosed with stage III and IV cancer and who are candidates and/or planned to receive immune check point inhibitors as a therapy now or in near future will be offered the Episwitch CiRT™ before starting treatment or if on active treatment. Those patients with high probability of response to ICI will undergo repeat testing every three months. Patients will be followed for up to six months. Treatment administered, disease-free survival, overall survival, stable disease, progressive disease, complete response, time to recurrence, physician questionnaires and patient-reported outcomes will be recorded for six months. Comprehensive data of Social Determinants of Health (SDoH) will be collected to identify any correlation to unmet Health Related Social Needs (HrSN) and likelihood to response and/or resistance

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Stage III or IV cancer
3. Selected by their healthcare provider to receive the Episwitch CiRT® test according to the current evidence-based schedule (per protocol) as part of their standard of practice.
4. ECOG performance status ≤ 2
5. Clinically eligible for ICI therapy
6. Able to read, understand and provide written informed consent.
7. Willing and able to comply with the study requirements

Exclusion Criteria:

1. Pregnant or breastfeeding
2. History of bone marrow or organ transplant
3. Contra indication for receiving Immune Check Point inhibitor.