cyrilzakka/clinical-trials huggingface dataset:
Mucus Solids Concentration in Patients With Bronchiectasis

There is a need for biomarkers that can rapidly and sensitively detect therapeutic benefits of therapies designed to "rehydrate" airways and monitor disease severity and progression. In this study the investigators will evaluate the stability of mucus concentration in patients with bronquiectasis (CF and NCBF) and its ability to respond to acute exacerbations in order to assess whether it can be a good candidate for biomarker.

Prospective cross-sectional study of repeated measurements. The recruitment will be performed in 3 different cities of Spain: Zaragoza, Barcelona and Murcia.

Subjects will be asked to repeatedly collect spontaneous and induced sputum samples in both stable and exacerbated conditions. All samples will be collected autonomously by patients in their homes after they have been instructed and supervised. Hypertonic saline nebulization will be used for sputum induction.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of CF (confirmed genetics) or diagnosis of non-CF bronchiectasis through high resolution computed tomography.
* Aged ≥ 18 years.
* Clinically stable at the time of recruitment.
* Chronic sputum production (able to produce spontaneous sputum daily).
* Current hypertonic saline user.
* Able to provide written informed consent and perform the trial.

Exclusion Criteria:

* Current smoker or \>10 pack-year history of tobacco use.
* Patient in transplantation or retransplantation list.
Arthrodesis Versus Extra-articular Plate Fixation in Lisfranc Injury

The purpose of this study is to compare arthrodesis of the first TMT-joint to extraarticular bridge plate fixation of the same joint in acute Lisfranc injuries.

We want to compare arthrodesis of TMT 1 to temporary bridge plating of TMT 1 in acute Lisfranc injuries where at least tarsometatarsal joints 1-3 are involved.

We preform arthrodesis of TMT 2 and 3 in both groups.

Eligibility Criteria:
Inclusion Criteria:

* Lisfranc injuries with instability off TMT1, and fracture/instability of TMT 2 and 3. No major fracture in relation to TMT1.
* Age 18-65

Exclusion Criteria:

* Feet with other major foot/ankle injuries
* Previous foot infection or foot pathology on affected side
* Previous surgery to the TMT joints
* Sequelae after previous foot injuries
* Diabetes mellitus, neuropathy and peripheral vascular disease
A Human Clinical Trial Evaluating the Effect of MealShape™ on Blood Glucose Level Following Consumption of Standard Meal

The purpose of the study is to evaluate the effect of MealShape, a Ceylon cinnamon extract (Cinnamomum zeylanicum) on blood glucose and insulin response after consumption of a standard meal composed of white bread, in healthy male and female volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female volunteers, able to read and write, aged from 18 to 45 years inclusive at time of screening
* Good physical condition
* Body Mass Index (BMI) ≥ 18,5 and \< 25 kg/m²
* Written informed consent provided prior to screening, after receiving and understanding the subject information
* Stable body weight (\< 5% variation) within the last 3 months prior to screening.
* Subject accepting to keep the same lifestyle throughout the study regarding physical activity, no smoking etc.
* Registered with the French Social Security, in agreement with the French law on biomedical experimentation.

Exclusion Criteria:

* Subject with type 1 or 2 diabetes
* Smoker. Light smoker (less than 5 cigarettes per day) or former smoker (smoking more than 5 cigarettes per day) having stopped less than three months. Smoking (or use of smoking substitute e.g. nicotine patch) is not permitted from screening throughout the study.
* Subject with fasting capillary blood glucose level \> 110 mg/dl.
* Subject with fasting capillary blood glucose level ≤ 110 mg/dl and 2 hours postprandial capillary blood glucose level \> 140 mg/dl during an Oral Glucose Tolerance Test.
* Subject with any sensitivity or allergy to any of the products used within this clinical trial.
* Intake of product (food and dietary supplement) having an effect on glycemia and insulinemia.
* Intake of all chronic medication excepted oestroprogestative or progestative contraception started at least three months preceding the screening visit.
PHenotyping patiENts Admitted to Hospital With cOvid-19 Infection and idenTifYing Prognostic markErs

PHENOTYPE is an investigator-led, observational cohort study which aims to explore the long-term outcomes of patients with COVID-19 infection and to identify potential risk factors and biomarkers that can prognosticate disease severity and trajectory.

In 2019, a novel coronavirus, SARS-CoV-2 was first identified in Wuhan, China. SARS-CoV-2 infection, denominated COVID-19, causes a predominantly respiratory illness, which varies from mild respiratory symptoms to multi-organ failure and death. In March 2020, COVID-19 was designated pandemic status and as of May 2020 there have been more than 3.7 million cases reported worldwide and 257,000 deaths attributed. In the UK, COVID-19 has caused more than 30,000 deaths to date.

Although respiratory symptoms are the commonest presentation, numerous systemic complications of COVID-19 have been identified, including those affecting the cardiovascular, neurological, gastroenterological, and renal systems. The long-term impact of these complications on survivors and the risk factors for long term sequelae is not presently known. It is likely that increased frailty and psychological sequelae will be significant, which could lead to a persistent reduction in quality of life, as observed in the previous SARS pandemic.

This cohort study aims to evaluate the respiratory, cardiac, renal and psychological outcomes of patients diagnosed with COVID-19 infection and determine the pathophysiological mechanisms that contribute to disease severity and disease burden.

Eligibility Criteria:
Inclusion Criteria

* Aged 18 years or older
* Confirmed COVID-19 infection (as per national guidelines)
* Attending follow-up outpatient visit post hospital attendance with COVID-19 infection

Exclusion Criteria

There are no specific exclusion criteria
Advanced Reperfusion Strategies for Refractory Cardiac Arrest

This is a Phase II, single center (Under the Center for Resuscitation Medicine at the University of Minnesota Medical School), partially blinded, prospective, intention to treat, safety and efficacy clinical trial, randomizing adult patients (18-75 years old) with refractory ventricular fibrillation/pulseless ventricular tachycardia (VF/VT) out-of hospital cardiac arrest (OHCA) who are transferred by emergency medical services (EMS) with ongoing mechanical cardiopulmonary resuscitation (CPR) or who are resuscitated to receive one of the 2 local standards of care practiced in our community: 1) Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation or 2) Standard Advanced Cardiac Life Support (ACLS) Resuscitation


Eligibility Criteria:
Inclusion Criteria:

* Adults (presumed or known to be aged 18-75 years, inclusive),
* An initial documented OHCA rhythm of VF/VT,
* No ROSC following 3 defibrillation shocks,
* Body morphology able to accommodate a Lund University Cardiac Arrest System (LUCAS™) automated CPR device, and
* Estimated transfer time from the scene to the ED or CCL of \< 30 minutes.

Exclusion Criteria:

* Age \< 18 years old or \> 75 years old;
* Non-shockable initial OHCA rhythm (pulseless electrical activity \[PEA\] or asystole);
* Valid do-not-attempt-resuscitation orders (DNAR);
* Blunt, penetrating, or burn-related injury, drowning, electrocution or known overdose;
* Known prisoners;
* Known pregnancy;
* Nursing home residents;
* Unavailability of the cardiac catheterization laboratory.
* Severe concomitant illness that drastically shortens life expectancy or increases risk of the procedure;
* Absolute contraindications to emergent coronary angiography including known anaphylactic reaction to angiographic contrast media and/or active gastrointestinal or internal bleeding
Levator Ani Muscle Avulsion at First Birth of Mexican Women: Randomized Control Trial

Levator Ani Muscle (LAM) avulsion occurs in 13-36% of women having their first birth. These damages by palpation and ultrasound of the pelvic floor can be detected. Avulsion of the LAM results in decreased muscle strength of the pelvic floor, enlarge the genital hiatus and promotes pelvic organ prolapse. The perineal muscle training is a proposal to combine the perineal massage with pelvic floor exercises in order to prepare the LAM in the last weeks before delivery, to withstand stretching which will be submitted during childbirth. No studies in the world that have explored the effect of the perineal muscle training on the avulsion of MEA.

Objective: To quantify the proportion of primiparous that result with avulsion of LAM after their first birth among those performing perineal muscle training from week 33 of gestation and those with usual prenatal care.

This study will be performed in 228 primiparous. Previous informed consent they will be randomized in two groups: 1) perineal muscle training and 2) usual prenatal care. Pelvic floor will be evaluated before and after childbirth clinically and ultrasonographilly. The outcome variables will be: 1) avulsion LAM diagnosed by palpation and 2-3D pelvic floor ultrasound, 2) symptoms of pelvic floor dysfunction identified with standardized and validated Spanish PFDI-20 questionnaire, 3) changes dimension of the genital hiatus and perineal body, 4) accomplishment of perineal muscle training. Demographic variables (marital status, occupation, level of education, age, weeks of gestation, weight, height, BMI, religion, pathologies) and variables related to childbirth (weeks of gestation duration of the second period, use of analgesia, variety of position, episiotomy, forceps. dystocia, who attended the birth, weight and head circumference of the newborn, tearing report and who repairs the last one.

Eligibility Criteria:
Inclusion Criteria:

1. Future primiparous over 18 who have single fetus, without contraindications to take delivery. Primigesta omit the term since in the study patients who have had previous pregnancies that are not related to damage to the pelvic floor as will be accepted: abortions, ectopic or molar.
2. With or without symptoms of pelvic floor dysfunction (assessed with PFDI-20 questionnaire).
3. Have 33 weeks gestation to start participating, so the invitation must be made before this gestational age as mentioned above.
4. Physical and mental ability to understand and perform the maneuvers used in the study.

Exclusion Criteria:

1. Any contraindication to labor, this feature can appear at any time during pregnancy, including during labor.
2. Physical or mental inability to perform the maneuvers used in the study.
3. Avulsion of MEA detected before birth.
4. Agree not participate in the study.
5. Previous pregnancies older than 20 weeks gestation resolved abdominally.
Preventing Recurrences of Chronic Subdural Hematoma in Adult Patients by Middle Meningeal Artery Embolization

Patients with a chronic subdural hematoma (cSDH), that is, a blood accumulation between two meninges developing over a long period of time, often have recurrent bleedings after an initial operation. The study aims to show that additional surgery reduces the risk of recurrent bleeding.

The additional procedure aims to block small blood vessels in the skull with tiny plastic particles. The small blood vessels are embolized using X-rays and a contrast medium and a fine tube that is inserted into the diseased vessels of the head via the groin.

Patients of full age who have undergone burr hole trepanation as a first operation, i.e. a blood drain through a hole in the cranial cavity, can participate in the study. Participating patients are randomly assigned to a control group with treatment according to clinical routine or a treatment group with an additional occlusion of the blood vessels in the skull. In addition, patients can consent to a genetic test to determine the relationship between a coagulation factor and the risk of recurrence of the hematoma. In order to record the test results, check-up examinations are carried out after one and three months.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who have undergone surgery by means of one or more burr hole trepanations during the first manifestation of a cSDH (unihemispherical or bihemispherical) detected by computed tomography or magnetic resonance tomography
2. Age ≥18 years
3. Sufficient compliance and ability to consent
4. Patient's informed consent for surgical as well as endovascular interventional procedure and participation in the study

Exclusion Criteria:

1. Conservatively treated cSDH
2. Radiological evidence of an acute or subacute subdural hematoma, subarachnoid hemorrhage, intracerebral hematoma or epidural hematoma
3. Surgical technique: craniotomy, craniectomy, bilateral burr hole trepanation
4. Angiography cannot be performed within 72 hours after surgery
5. Age \<18 years
6. Supervisory relationship
7. Pregnancy
8. Lack of informed consent
9. Lack of compliance
10. Homozygous factor XIII deficiency with residual activity \<10%
Neurofeedback in Decreasing Acute Radiotherapy-Induced Pain in Patients With Head and Neck Cancer

This pilot trial studies how well neurofeedback training works in decreasing acute radiotherapy-induced pain in patients with head and neck cancer. Neurofeedback training is a type of therapy that uses electroencephalograph and a computer software program to measure brain wave activity. Neurofeedback training may help teach patients ways to modify their own brain waves to decrease the perception of pain and improve quality of life.

PRIMARY OBJECTIVES:

I. Determine the effects of an individualized LORETA (low resolution electromagnetic tomography) Z score neurofeedback program on changes in brain function using EEG (electroencephalography), qEEG (quantitative electroencephalography), and LORETA from immediately before to after each session in patients with head and neck cancer undergoing radiotherapy and experiencing pain.

SECONDARY OBJECTIVES:

I. Examine the effects of an individualized LORETA Z score neurofeedback program on perceptions of radiation-induced pain in head and neck cancer patients from immediately before neurofeedback training to immediately after neurofeedback training.

II. Identify brain regions from qEEG and LORETA that are associated with a non-pain state and then an acute pain state.

III. Examine the relationship between the patient and their spouse or primary caregiver.

OUTLINE:

Beginning at weeks 4 and 5 or 5 and 6 of radiotherapy, patients undergo neurofeedback training once per day (QID) three times per week (TIW) for up to 6 treatments. Patients also complete questionnaires over 10 minutes at baseline and after neurofeedback training.

After completion of study, patients are followed up at 1 week.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have the ability to understand and read English, sign a written informed consent, and be willing to follow protocol requirements
* Patients must not have pain \> 2 on a scale of 0 - 10 (self report) in the head and neck before starting radiotherapy
* Scheduled to undergo a 6 week course of radiotherapy for head and neck cancer
* No plans to change the type of pain medication during the course of the study

Exclusion Criteria:

* Patients who are taking any antipsychotic medications
* Patients with active central nervous system (CNS) disease, such as clinically-evident metastases or leptomeningeal disease, dementia, or encephalopathy
* Patients who have ever been diagnosed with bipolar disorder or schizophrenia
* Patients with known, previously diagnosed head or neck pain from other pain syndromes or chronic pain requiring analgesics
* Patients with a history of seizure disorders
Bacillus Clausii in Liver Transplantation

A prospective, randomized, controlled study of the safety and efficacy of using Bacillus clausii probiotic oral preparation to decrease the incidence of infection during the first 30 days after living donor liver transplantation surgery.

Patients planned for living donor liver transplantation would be randomized to either intervention or control group 2 weeks before surgery. Intervention group shall receive Bacillus clausii probiotics for 2 weeks. patients in both groups would be followed-up for adverse events and signs and symptoms of infection up to 30 days postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 - 65 years.
* Patients suffering from end stage liver disease (ESLD) with any etiology listed on waiting list and accepting to volunteer in the study with the informed consent.
* Patients not suffering from any active infection at the start of the study.

Exclusion Criteria:

* Patients with poorly controlled autoimmune disease on immunosuppression before transplantation.
* Patients who undergo combined kidney-liver transplantation.
* Patients with severe renal insufficiency (creatinine clearance \<50 ml/min).
* Patients with intestinal obstruction (ileus).
* Patients with cerebral disorders with danger of aspiration.
* Patients with roux en Y-anastomosis.
* Patients with cystic fibrosis.
* Retransplantation.
Glutamatergic Amino Acids and Oxytocin Levels in the Plasma of Patients in First Psychotic Episode (FPE)- Before and After Neuroleptic Treatment

The goal of our research is to check the levels of D-Serine, Glycine, and other Glutamatergic amino acids, in patients with First Psychotic Episode (FPE). These patients are in the early stage of the disease, treated with neuroleptics for short periods of time, and are usually hospitalized for the first time. The hypothesis of the research is that we will find low levels of Glycine and D-Serine in these patients. Following an Anti-psychotic treatment we will expect these levels to return to the norm, and that this correction will be accompanied by a reduction of positive and negative symptoms.

In addition, we will check the D-Serine and Glycine levels in the plasma of first degree relatives of the patients and a group of healthy subjects. The results of this study might support the hypothesis that the Glutamatergic system in involved in the pathology of Schizophrenia from it's early stages.

In addition, we will check the levels of Oxytocin and Estrogen in the plasma of patients in FPE. Our hypothesis is that we will find low levels of Estrogen and High levels of Oxytocin in this group of patients. The results of the study might support the hypothesis that Estrogen and Oxytocin are involved in the pathology of Schizophrenia from it's early stages.


Eligibility Criteria:
Inclusion Criteria:

* Subjects between 18-60 years
* Clinical Diagnosis of Schizophrenia, Schizophreniphorm disorder, Schizoaffective Disorder, Brief esychotic episode

Exclusion Criteria:

* two years or more of positive symptoms
* Neuroleptic treatment for more then twe weeks in the prior month, or for more then six weeks at any time.
* Drug induced psychotic episode
Association Between VEGF-C and miRNA and Clinical Non-small Cell Lung Cancer and Esophagus Squamous Cell Carcinoma

Lung cancer and esophageal cancer remain the leading causes of cancer death worldwide. The main problem is lack of effective tool in early detection that accounts for the poor outcome of cancer. Clinically, over 80% of patients with cancer were at late stage when they were diagnosed. Therefore, it is important for us to find the biomarker that serve as the early prediction of cancer.

The investigators have published that VEGFC over-expressed in non-small cell lung cancer. VEGFC plays a critical role in regulating motility of tumor cells, promotes proliferation of lymphatic endothelial cells and enhances migration and invasion. Investigator found that VEGFC over-expressed in the serum of esophageal cancer patients. Therefore, it is worthwhile to investigate the correlation between VEGFC, clinical lung cancer and esophageal cancer.

MicroRNAs (miRNAs) are conserved, endogenous, small, and noncoding RNA molecules of 21\~23 nucleotides that function as post-transcriptional gene regulators. Recent studies indicated that certain microRNAs reduced in cancer patients. Therefore it is important to investigate whether specific microRNA changed in certain kinds of cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* tumor size \> 0.5 cm3

Exclusion Criteria:

* tumor size \< 0.5 cm3
Hydrotherapy Versus Classical Rehabilitation After Surgical Rotator Cuff Repair

Postoperative rehabilitation following rotator cuff repair is important to promote tendon healing, restore strength, and recover normal function. The aim of this study is to assess whether aquatic rehabilitation is more efficient than classical rehabilitation (land-based session) in term of range of motion, function, and pain than classical rehabilitation (land-based session) after an arthroscopic repair of the rotator cuff.

Introduction:

Postoperative rehabilitation following rotator cuff repair is important to promote tendon healing, restore strength, and recover normal function. Aquatic rehabilitation in hot water allows body relaxation and well-being that promote patient conditioning for efficient rehabilitation and is appreciated by patients. The aim of this study is to assess whether aquatic rehabilitation is more efficient than classical rehabilitation (land-based session) in term of range of motion, function, and pain after an arthroscopic repair of the rotator cuff.

Methods:

This prospective case-control clinical study is randomized 1:1 between rehabilitation with hydrotherapy and land-based (standard) rehabilitation. This superiority trial that included 84 patients that have benefited from an arthroscopic superior cuff repair. Patients were evaluated clinically at 6 weeks, 3, 6 and 24 months and using ultrasound at 6 months. Multivariable linear regressions were performed to determine if 2-year postoperative scores were associated with gender, body mass index (BMI), age at index operation, rehabilitation group (Hydrotherapy vs Standard), and baseline passive range of motion (PROM) Active range of motion (AROM).

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or more
* Arthroscopic cuff repair of supraspinatus tendon (with potentially concomitant of infraspinatus tendon repair, tenodesis or tenotomy of brachial biceps tendon, acromioplasty, and distal clavicle removal).

Exclusion Criteria:

* Lesion of subscapularis tendon;
* SLAP lesion;
* Second rotator cuff surgery;
* Frozen shoulder (i.e. Forward flexion reduced of 25% or more);
* Inability to follow the study protocol