cyrilzakka/clinical-trials huggingface dataset:
Prospective Validation of a Pre-Specified Algorithm for the Management of Conduction Disturbances Following TAVR

The high incidence and variety of conduction disturbances post-TAVR represents a major challenge in the periprocedural management of TAVR recipients. Despite the growing body of knowledge on this topic, the large variability in the management of these complications has translated into a high degree of uncertainty regarding the most appropriate treatment of a large proportion of such patients. The implementation of a pre-specified treatment strategy translating into a more uniform practice regarding the management of conduction disturbances post-TAVR applied to a large cohort of patients would permit to identify the benefits and drawbacks of each specific aspect of the treatment algorithm proposal. This may also help to improve both the management and clinical outcomes of the complex group of patients with conduction disturbances associated with TAVR. In the end, the final objective of a pre-specified strategy for managing conduction disturbances post-TAVR should be to obtain a low rate of PPM without increasing the risk of sudden death or life threatening arrhythmic events following hospital discharge, and all this while avoiding an excessive prolongation of the hospitalization period following the TAVR procedure.

The objectives of the study are:

* Feasibility: to validate and determine the applicability of a pre-specified algorithm for managing conduction disturbances in consecutive patients undergoing TAVR, also evaluating the percentage of patients included in each group of the algorithm strategy.
* Efficacy: (i) to evaluate the rate of permanent pacemaker implantation in-hospital and at 30 days compared to that of the year prior to the implementation of the protocol, (ii) to determine the incidence of sudden death at 30 days and at 1-year follow-up.

Eligibility Criteria:
Inclusion Criteria:

-Patients with aortic valve disease undergoing transcatheter aortic valve replacement

Exclusion Criteria:

* Prior permanent pacemaker
* Failure to provide signed informed consent for data collection
* Impossibility for a follow-up
* Unwillingness to follow the pre-specified strategy for the management of conduction disturbances
Efficacy of Seluang Fish Oil (Rasbora Argyrotaenia) and Synbiotics Supplementation on CD4+CD25+ Foxp3+ T-regulator Cells, IL17/IL-10 Ratio, and Disease Activity in Systemic Lupus Erythematosus Patients

The study aimed to evaluate the efficacy of seluang fish oil (Rasbora argyrotaenia) and synbiotics (containing Lactobacillus helveticus R0052 60%, Bifidobacterium infantis R0033 20%, Bifidobacterium bifidum R0071 20% and frukto-oligosaccharide 80 mg) supplementation compared to placebo towards Systemic Lupus Erythematosus disease activity Index (SLEDAI)-2K score, IL-17/IL-10 ratio and CD4+ CD25+ Foxp3+T-regulator levels in Systemic Lupus Erythematosus (SLE) patients. The current study was designed as a single-center double-blind randomized controlled clinical trial. The participants were voluntarily recruited 18-55 years old SLE patients diagnosed based on SLICC criteria, with mild to moderate disease activity, were clinically stable for ≥ 4 months (on prednison ≤ 20 mg/day or equivalent) and willingly ceased vitamin D and probiotic consumption during the trial study. Participants were randomized into two groups receiving seluang fish oil and synbiotics supplementation, or placebo. Evaluations were conducted on week 4, 8 and 12 for clinical symptoms, side effects and adherence. IL-17/IL-10 ratio and CD4+ CD25+ Foxp3+T-regulator levels were evaluated at the beginning and at the end of the 12 week trial for analysis.


Eligibility Criteria:
Inclusion Criteria:

* Patients who meet the SLICC criteria
* Patients with mild to moderate SLE (mild if SLEDAI-2K score \&lt; 6 and moderate if SLEDAI-2K score: 6-12)
* Aged 18-55 years
* Willing to stop consuming vitamin D or multivitamin supplements containing vitamin D for at least 3 weeks before participating in the study
* Willing to stop consuming probiotics that were previously taken for at least 1 week before participating in the study
* If using prednisone, the dose must be stable (corticosteroid equivalent ≤ 20 mg/day) for at least 4 weeks before the study
* Willing to sign informed consent

Exclusion Criteria:

* Patients with severe SLE
* Patients with SLE with hypercalcemia (\&gt; 2.60 mmol/l)
* Patients with SLE with liver dysfunction: serum Aspartate Transferase (AST) - and Alanine Transferase (ALT) levels \&gt; 2 times the normal value or total serum bilirubin \&gt; 1.5 times the normal value
* Patients undergoing hemodialysis or patients with serum creatinine \&gt; 2.5 mg/dL
* Pregnant patients
* Patients with SLE with immunocompromised conditions such as HIV
* Patients with SLE with chronic infections such as pulmonary tuberculosis
* Patients currently undergoing antibiotic therapy

Drop out criteria:

* Patients who have been off medication for more than 3 weeks
* Patients who have passed away
* Patients who consume yogurt or supplements containing probiotics/synbiotics more than once consecutively in 1 week
* Patients who experience a change in immunosuppressive agents during the study
* Patients who are hospitalized due to a worsening condition during the intervention period
* Loss to follow-up
Fasting and Exercise-induced Changes in Human Skeletal Muscle

This study examines the impact of increasing energetic stress during an 8-hour fast on metabolic pathways in human skeletal muscle. Specifically, participants will undergo two 8-hour fasting sessions in a randomized crossover fashion, with the addition of low-intensity arm exercise in one of the sessions. Changes in metabolic pathways will be examined in resting (leg) muscle before, during, and after the fast.


Eligibility Criteria:
Inclusion Criteria:

* recreationally active (no more than 3 hours of weekly physical activity)
* not currently involved in a systematic training program
* body mass index \< 30 kg/m2

Exclusion Criteria:

* presence of cardiometabolic disease
* taking regular oral medication
* current smoker
Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema

The purpose of this study is to assess the efficacy and safety of Icatibant, a bradykinin antagonist in the treatment of acute cutaneous and/or abdominal attacks in patients with hereditary angioedema (HAE).

This Phase II/III study consisted of two parts: A controlled phase and An Open label extension(OLE) phase. The controlled phase describes the double blind part of the study and was intended to evaluate the efficacy of icatibant in decreasing the time to onset of symptom relief compared with placebo for the first treated cutaneous and/or abdominal attack in randomised patients. Patients experienced a laryngeal attack were not randomised, but treated with open label icatibant according to the controlled phase procedures and assessments. The outcome of this group was to be reported descriptively. After treatment of the first attack in the controlled phase, the patients were eligible to enter the OLE phase. In the OLE phase, patients who experienced angioedema attacks severe enough to warrant treatment were to be treated with s.c. icatibant as appropriate until the end of the study.The OLE phase became a modified open label extension where all 56 patients who had been randomised and the last randomised patient had concluded the double-blind phase. The modified open label extension period permitted treatment for patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the double blind phase was still ongoing.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years;
* Documented diagnosis of HAE Type I or II (confirmed complement 1 esterase inhibitor \[C1-INH\] deficiency);
* Current edema be in the cutaneous, abdominal and/or laryngeal areas;
* Current edema be moderate to severe according to the investigator's Symptom Score.

Exclusion Criteria:

* Diagnosis of angioedema other than HAE, for example, acquired angioedema (AAE);
* Participation in a clinical trial of another investigational medicinal product (IMP) within the past month;
* Treatment with any pain medication since onset of the current edema attack;
* Treatment with replacement therapy, including C1-INH products (e.g. human C1-INH preparations), less than 3 days from onset of the current edema attack;
* Treatment with ACE inhibitors (e.g. Lotensin, Prinivil, Accupril);
* Evidence of severe, symptomatic coronary artery disease based on medical history or screening examination;
* Serious concomitant illnesses that the physician considers to be a contraindication for participation in the trial;
* Pregnancy and/or breast-feeding.
Clinical Trial of the S. Flexneri-S. Sonnei Bivalent Conjugate Vaccine

The goal of this clinical trial is to evaluate the protective efficacy of S. Flexneri-S. Sonnei bivalent conjugate vaccine against diarrhea caused by Shigella infection in infants and children aged 6 months to 5 years. Researchers will observe the incidence of diarrhea of any severity due to Shigella flexneri and Shigella sonnei infection 30 days after full immunization. The subjects will receive 2 doses of vaccination.


Eligibility Criteria:
Inclusion Criteria:

* Infants and children aged 6 months to 5 years.
* Legal guardians voluntarily agree to participate in the study and sign an informed consent form.
* Legal guardians agree to comply with the requirements of the clinical trial protocol and are willing and able to participate in all planned follow-ups.
* The subject's guardian agrees that the subject should not abuse antibiotics. If needed，antibiotics should be used under the guidance of a doctor and avoid taking antibiotics on their own during the clinical trial.
* Based on medical history, physical examination, and the investigator's judgment, the subject is determined to be in good health.

Exclusion Criteria:

* History of confirmed bacterial dysentery in the past 6 months.
* Serious allergy to tetanus toxoid, history of severe allergies, fever above 39.5°C following previous vaccination with a prophylactic biological product.
* Currently suffering from serious intestinal diseases, symptoms of diarrhea, abdominal pain, or bloody purulent stools in the past 15 days.
* Diagnosed pathological jaundice currently.
* Confirmed diagnosis of thrombocytopenia or other coagulation disorders.
* Known or suspected immunological deficiencies (e.g., perianal abscesses indicating potential immune deficiency in infants and young children), long-term treatment (≥14 days) with immunosuppressants within half a year before vaccination (radiotherapy, chemotherapy, systemic corticosteroids ≥2 mg/kg/day, antimetabolites, cytotoxic drugs), or parents confirmed to have HIV infection.
* Receipt of immunoglobulins/blood products (except hepatitis B immunoglobulin) within 3 months before vaccination.
* Severe congenital anomalies (important organ function impairment), severe malnutrition, developmental disorders, severe hereditary diseases.
* Currently suffering from the following diseases:

  1. Severe liver or kidney diseases, cardiovascular diseases, malignant tumors, and other severe chronic diseases.
  2. Diagnosed serious infectious diseases, such as tuberculosis, viral hepatitis, etc.
  3. Severe asthma.
  4. Generalized rashes, dermatophytosis, skin suppuration, or blistering.
  5. Convulsions, epilepsy, encephalopathy, psychiatric disorders or family history of psychiatric disorders.
* Planning to participate or currently participating in other vaccine or drug clinical trials.
* Any condition that the investigators believe may affect the evaluation of the study.
A Single and Multiple-Ascending Dose Study of CRN01941 in Healthy Adult Volunteers

This is a Phase 1, double-blind, randomized, placebo-controlled, single-dose and multiple-dose study of CRN01941 in up to 119 healthy male and female subjects. This single-center study will be conducted in 3 parts: a single-ascending dose phase (up to 8 cohorts, 8 subjects/cohort), a multiple-ascending dose phase (up to 5 cohorts, 9 subjects/cohort), and single dose phase in elderly subjects (1 cohort, 10 subjects).


Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects 18 to 55 years of age, inclusive, at time of screening (Parts 1 and 2 only).
2. Males and females subjects 65 to 85 years of age at screening (Part 3 only).
3. Females must be non-pregnant and non-lactating, postmenopausal by history and confirmed by follicle stimulating hormone (FSH) \>30 U/L at Screening, or surgically sterile.
4. Male subjects must be surgically sterile or agree to use highly effective form of contraception when sexually active with a female partner of child bearing potential.
5. Body mass index (BMI) of 18 to 32 kg/m2, inclusive at Screening.
6. Willing to provide signed informed consent.

Exclusion Criteria:

1. Any uncontrolled or active major systemic disease which makes study participation unsafe or could interfere with evaluation of the endpoints of the study.
2. History or presence of malignancy within the past 5 years, not including treated basal cell carcinomas and in situ cervical neoplasia.
3. Use of any investigational drug within the past 60 days.
4. Have a medically significant abnormality observed during screening or admission.
5. Use of any prior medication without approval of the investigator within 14 days prior to admission.
6. Subjects with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infections. Subjects with previous hepatitis C infection that is now cured may be eligible.
7. History of or current alcohol or substance abuse in the past 12 months
8. Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this Phase 1 study.
Perioperative Music in Obese Patients Under Spinal Anesthesia

The goal of this clinical trial is to learn whether music or midazolam has a greater anxiolytic effect on obese patients undergoing spinal anesthesia. It will also determine the safety of music compared to midazolam in this population (differences in blood pressure, heart rate, oxygen saturation). The main question to answer: Music or midazolam is more effective in reducing anxiety in obese patients under spinal anesthesia?


Eligibility Criteria:
Inclusion Criteria:

* patients who are \> 18 years old
* patients with Body Mass Index -ΒΜΙ\>30 kg/m2
* patients who will give informed consent in receiving spinal anaesthesia
* patients who will give informed consent in participating in the study

Exclusion Criteria:

* absolute contraindications of spinal anaesthesia,
* severe psychiatric, cognitive or sensory impairment
* mother language other than greek,
* known hypersensitivity to midazolam,
* renal impairment
Effectiveness and Safety Study of LAP-BAND Treatment in Subjects With BMI >/= 30 kg/m2 and < 40 kg/m2

The purpose of this study is to determine whether the LAP-BAND system is safe and effective in subjects with BMI ≥ 30 kg/m2 and \< 40 kg/m2.

LBMI-001 is a multi-center, prospective, longitudinal, non-randomized study whose purpose is to determine whether the LAP-BAND system is safe and effective in subjects with BMI ≥ 30 kg/m2 and \< 40 kg/m2. Primary and secondary outcome measures were analyzed at 1 year post LAP-BAND implantation. Subjects continued to be followed for 5 years post-implantation, and 5 year data was evaluated in Post-Hoc outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* Have a BMI ≥ 30 kg/m2 and \< 35 kg/m2 (with or without comorbid conditions) or a BMI ≥ 35 kg/m2 and \< 40 kg/m2 without severe comorbid conditions
* Have a history of obesity for at least 2 years and have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavior modification programs

Exclusion Criteria:

* Subject history of congenital or acquired anomalies of the gastrointestinal tract
* Severe cardiopulmonary or other serious or uncontrolled organic disease
* Severe coagulopathy; hepatic insufficiency or cirrhosis
* History of bariatric; gastric; or esophageal surgery
* History of intestinal obstruction or adhesive peritonitis
* History of esophageal dysmotility disorders
* Type I diabetes
Effect of Partial Sleep Deprivation on Immunological System in Peripheral Blood

Sleep deprivation was found to affect many organs including the immune system and predisposing for various health consequences including diabetes hypertension infections and increase in neoplastic diseases.

Subjects will be evaluated for immune parameters in peripheral blood test following a regular nigh sleep and compared with a test performed following a night shift in which they slept less than 3 hours.

Each participant will serve as its own control.

Overall Study Design and Plan

1. Subjects will be bled on the day of the experiment between 8and 9 AM.
2. Blood tubes will be tested for T cell markers, serum cytokines levels, and other immune parameters by western blots.
3. The first tube will be tested on the day of experiment.
4. The second tube will kept in the lab and will be tested 24 hours later.
5. The third tube will be kept in the pocket of the subject and be tested 24 hours later.
6. The fourth tube will be kept in the pocket of another subject and will be tested 24 hours later.
7. The subject will be tested again following 24 hours.
8. Each subject will be tested twice following a regular 6-8 hours of sleep, and following an on call duty in which he slept less than 3 hours.

Eligibility Criteria:
Inclusion Criteria:

Male and female ages 18-40 signed confirmed consent no evidence of chronic disease or chronic medications

Exclusion Criteria:

Any type of acute infection or other acute illness
Prognosis of SRD Patients in the ICU

Critically ill systemic rheumatic disease (SRD) patients have benefited from better provision of rheumatic and critical care in recent years. Recent comprehensive data regarding in-hospital mortality and most importantly long-term outcome are scarce. The aim of this study is to assess short and long-term outcome of patients with SRD admitted to the ICU in a retrospective cohort study (2006 - 2016).


Eligibility Criteria:
Inclusion criteria:

* All consecutive SRD patients admitted to ICUs during the study period
* at least one urine sample

Exclusion criteria:

* Age \< 18 years
* Persons under protection
* Paritcipation rejections
* Admition to the ICU after scheduled surgery or trauma or suicide attempt unrelated to neurological involvement of SRD
* Cancer treated with chemotherapy within a month before ICU admission
Profiling Program of Advanced/Metastatic Pancreatic Cancer Patients

The proposal is to implement a molecular screening program for advanced/metastatic pancreatic cancer patients before the initiation of 1st line treatment in order to allow a better selection of patients for rationale personalized medicine with targeted agents and/or combination involving a chemotherapy backbone.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient \> 18 years
* metastatic or advanced PDAC
* Patient pretreated with no more than one prior systemic chemotherapy for metastatic/advanced disease (radiotherapy is not counted as a line of therapy).
* Availability of an archival representative FFPE tumor sample from primary tumor (surgery or diagnostic biopsy) and/or from metastatic lesion if metastatic disease at initial diagnosis with associated pathology report from an archival tumor block.
* Life expectancy \> 3 months
* PS score 0 or 1.

Exclusion Criteria:

* Curative therapy available
* Any condition contraindicated with blood sampling procedures required by the protocol.
* Known additional malignancy that is progressing or requires active treatment. Exceptions include adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer.
* Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.
Assessing the Efficacy of Maxidex® and Patanol® for the Treatment of Allergic Conjunctivitis

The purpose of this study was to evaluate the efficacy of Maxidex and Patanol compared to placebo in patients with allergic conjunctivitis when exposed to controlled allergen levels in an Environmental Exposure Chamber (EEC).

This study consisted of 6 visits. Visit 1 was the Medical Screening Visit (skin prick test). Visit 2 and Visit 3 consisted of 2 consecutive EEC Visits (3 hours in the EEC followed by 7 hours in the Clinic, 10 hours total, each visit) followed by 7 days of wash-out. Visit 2 and Visit 3 occurred prior to dispense and the measures obtained during these visits were used as baseline. At Visit 4 patients were randomized and dispensed the assigned study medication for 7 days of at-home dosing. Visit 5 (Day 8 of treatment) and Visit 6 (Day 9 of treatment) consisted of 2 additional consecutive EEC Visits (3 hours in the EEC followed by 7 hours in the clinic, 10 hours total, each visit). During each EEC visit, patients were exposed to either ragweed or cat allergen, depending on their skin prick test results. Of the 180 participants enrolled, 170 received at least one dose of study treatment and were randomized to one of the three study treatments.

Eligibility Criteria:
Inclusion Criteria:

* At least 1 year history of allergic conjunctivitis.
* Ability to self administer ophthalmic drops.
* Ability to avoid use of disallowed medications during the entire study period and specified period prior to visit 1.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Presence of any ocular infection.
* Confirmed diagnosis of dry eye.
* Presence of glaucoma or ocular hypertension.
* Moderate to severe asthma.
* Any severe, unstable, or uncontrolled systemic disease.
* Other protocol-defined exclusion criteria may apply.
Medihoney® Derma Cream Treatment for Mild to Moderate Atopic Dermatitis in Children Study

A randomized, open-label trial comparing Medihoney Derma Cream to Hydrocortisone 1% cream. Children between the ages of 2-18 years old diagnosed with mild to moderate atopic dermatitis with an IGA (Investigator Global Assessment) score of 2-3, and a BSA (Body Surface Area) score of 1%-10% were included.

A randomized trial comprising children aged 2-18 diagnosed with mild to moderate AD, with an IGA of 2-3 and BSA of 1%-10%, including 30 patients, 20 using Med-D-Cream and 10 as controls using Hydrocortisone 1% cream. Patients applied creams for 2 weeks and were then followed for two weeks to measure clinical responses and pruritus change.

Eligibility Criteria:
Inclusion Criteria:

* 2-18 years old
* mild to moderate atopic dermatitis
* an IGA score of 2-3
* BSA score of 1%-10%.

Exclusion Criteria:

* participation in any clinical trial less than 28 days before the enrollment
* AD-related systemic therapy or phototherapy within 28 days prior to the enrollment
* topical corticosteroids, calcineurin inhibitors, or PDE4 inhibitors use within 7 days prior to the enrollment