cyrilzakka/clinical-trials huggingface dataset:
AMIOdarone vs. Catheter Ablation for Prevention of Recurrent Symptomatic Atrial Fibrillation

Randomized trial of low-dose amiodarone therapy versus catheter ablation (CA) in older patients with persistent atrial fibrillation (AF).

Primary Objective: To compare amiodarone to catheter ablation in patients aged 50 to 80 years with symptomatic AF for the composite outcome of hospitalization for cardiovascular cause or emergency department visit for atrial arrhythmia

This is a single centre vanguard phase prospective randomized open label study with blinded outcome adjudication.

Patients will be randomized by a central randomization system (1:1) to amiodarone or catheter ablation.

1. Amiodarone will be started at a dose of 400 mg/day. After one month the dose will be lowered to 200 mg per day. Patients will be seen every six months. At each visit the dose of amiodarone will be lowered by 100 mg per week if the patient is having a good clinical response to treatment. Good clinical response will be a a clinical assessment that takes into account not only actual or possible arrhythmia recurrence but also side-effects and patient acceptability of treatment. A minimum dose of 700 mg/week will be allowed. If patient symptoms recur, the amiodarone dose may be increased but not above a dose of 200 mg/day .
2. Catheter ablation of persistent AF will be done within two months using pulmonary vein isolation in all subjects
3. Patient not in sinus rhythm at time randomization will undergo DC cardioversion after at least 1 month of amiodarone Rx or during CA.

Follow up: Clinical assessment will include a medical history and physical examination to be performed at baseline, and every 3 months. This will also include 12-lead ECG.

b. At 3, 6, 12, 18, and 24 months: QOL questionnaire (AFEQT- Atrial Fibrillation Effect on QualiTy of life) c. Thyroid and liver function tests, chest X-ray will be obtained at regular intervals.

d. Arrhythmia will be monitored using a 2-week event monitors at 6, 12, 18, 24 months.

Eligibility Criteria:
Inclusion Criteria:

1. Recurrent symptomatic Atrial Fibrillation (AF)
2. Age 50-80 years with persistent AF (≥1 of AF episode lasting more than a week or requiring cardioversion)

Exclusion Criteria:

1. Permanent atrial fibrillation
2. Prior continuous use of amiodarone of more than 2 weeks.
3. Prior catheter ablation for AF.
4. Have a documented resting heart (while awake) of \< 50 beats per minute.
5. Have a known severe liver disease.
6. Are deemed not suitable for CA (LA size, comorbidities...).
7. Have a severe valvular disease or have a mechanical mitral prosthesis.
8. Have a life-expectancy of less than 2 years.
Effects of a Complex Cognitive Training in Mild Cognitive Impairment and Mild Alzheimer's Disease

A recent meta-analysis that included over 29.000 individuals found that the odds ratio (OR) of individuals with high brain reserve compared to low was 0.54 (p \< 0.0001), a risk decrease of 46%. Among the factors that influence cognitive reserve, mentally stimulating activities was the most robust factor after controlling for education, age, occupation and other potential confounds. The brain reserve effect was sustained over a median longitudinal follow-up of 7 years. It would be interesting to detect whether a complex cognitive training could show similar effects on the cognitive abilities of patients with mild Alzheimer's disease (AD) and mild cognitive impairment (MCI) as it has been reported in previous studies based on mentally stimulating activities analysis.

The hypothesis is that a complex cognitive training alters the neural networks in both subject groups and this alteration is associated with improvement or stabilization of cognitive and non-cognitive function.

The investigator will perform a complex cognitive training program. Twenty patients with mild AD and twenty four patients with MCI will be recruited in this study. The patients will be randomised in control- and treatment groups.Additionally indirect effects on non-cognitive functions will be evaluated in caregivers of the patients.

The investigators expect that the cognitive and non-cognitive abilities will be changed during the cognitive training. The investigators also expect differences between treatment and control groups.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged ≥ 55 years, fulfilling criteria of the National Institute of Neurological and Communicative Disease and Stroke (NINCDS) and the Alzheimer's Disease and Related Disorders Association (ADRDA) for the diagnosis of clinically probable AD or Petersen's criteria of mild cognitive impairment (MCI)
* No evidence for other psychiatric axis I disorders according to DSM-IV criteria
* No uncontrolled arterial hypertension or diabetes mellitus
* No history of drug/alcohol abuse
* Cholinesterase inhibitors or Memantine must have been in a stabile doses at least 2 moths in AD subject group prior to the Baseline
* The patient is able to provide written informed consent to participate in the study. If, at investigator's discretion, a patient is considered not to be capable to give legal consent, then written consent must also be obtained from the patient's legally acceptable representative.

Exclusion Criteria:

* Evidence for other psychiatric axis I disorders according to DSM-IV criteria
* Uncontrolled arterial hypertension or diabetes mellitus
* History of drug/alcohol abuse
* No ability to participate and no willing to give informed consent and comply with the study restrictions
Effect of Exercise Training in Coronary Artery Disease Patients After Stenting

To determine the effects of exercise training on ankle-brachial index and Quality of Life in coronary artery disease patients after stenting. There is a need to develop strategies, not only to prevent restenosis but also to improve patients' functional status and perception of well-being. In particular, it is not well defined whether exercise training can reduce the restenosis rate and improve the outcome after percutaneous intervention (PCI), and its effects on the Ankle-brachial index are not yet well known.

The existence of PAD in patients with Coronary artery disease (CAD) remarkably increases the risk of cardiovascular morbidity and mortality. Almost half of the patients, after an initial encouraging improvement in functional capacity and quality of life (QOL) after the PCI, deal with recurrent chest pain that requires medical attention, reduces functional capacity, and creates a status of psychological distress.

Eligibility Criteria:
Inclusion Criteria:

* GCS = 15
* Disease chronicity: 1-3 years Elective / stenting procedure
* Single or Double vessel stunting EF: 35 above

Exclusion Criteria:

* Unwilling to participate in research
* Known cases of Uncontrolled DM or HTN
* Known cases of Cognitive/memory/neurological disorders
* Known cases of any Systemic disease
Safety and Tolerability Study of Ragweed SLIT Tablets

The purpose of this study is to determine the safety and tolerability of several doses of ragweed pollen allergen extract administered as sublingual tablets in subjects with allergic rhinitis to ragweed.


Eligibility Criteria:
Inclusion Criteria:

* written consent
* male or female subjects from 18 yo 60 years old and in general good health
* for women of child bearing potential: negative urine pregnancy test and use of medically effective contraceptive method
* symptoms of ragweed pollen induced allergic rhinitis for at least the last 2 years
* sensitization to ragweed pollen as demonstrated with positive skin prick test to ragweed pollen and specific IgE level (ragweed pollen) \> 0.70 kU/l at screening
* FEV1 at least of 80% of predicted value at screening

Exclusion Criteria:

* past or current disease which, as judged by the investigator, may affect the outcome of this study
* history of life-threatening asthma
* asthma requiring daily treatment (whatever the pharmaceutical class)
* pregnant or lactating women
* subjects who previously received desensitisation treatment to ragweed pollen and/or other Asteraceae or who plan to start desensitisation treatment during this study
* symptoms during the treatment phase due to a sensitivity to a second allergen
* subjects treated with ongoing immunotherapy with another allergen
A Clinical Study to Investigate Collagen Matrix 10808 for Soft Tissue Volume Augmentation Around Single Implants

The objective of this study is to investigate the safety and the function of the collagen Matrix 10808 in humans and to compare it versus the standard therapy, the transplantation of the autologous connective tissue graft. The Collagen Matrix was developed for soft tissue augmentation. It is a three dimensional porous Matrix and consists mainly of Collagen I and III.

Study patients must have a single tooth gap with insufficient soft tissue volume after implant placement. Therefore a soft tissue augmentation will be necessary.

The primary objective of this study is to assess the effectiveness of soft tissue volume augmentation procedures using the autogenous soft tissue graft or the Collagen Matrix 10808 to gain mucosal thickness. Second the safety of the two procedures will be investigated.

Eligibility Criteria:
Inclusion Criteria:

1. Implant placement at least 6 weeks and maximum 6 months prior enrolment
2. Necessity of soft tissue augmentation in single tooth gap
3. 2 teeth adjacent to each side of the defect have a mean BOP (Bleeding of probing) of \< 30%
4. Basic periodontal examination (BPE \<2)
5. 18 years or older
6. Ability to comply with the study-related procedures such as exercising good oral hygiene and attending all follow-up procedures
7. Ability to fully understand the nature of the proposed surgery and ability to sign the informed consent form

Exclusion Criteria:

1. Heavy smoker (\> 10 cigarettes per day)
2. Probing depth greater than 4 mm
3. Insulin dependent diabetes
4. General contraindications for dental and/or surgical treatment
5. History of malignancy, radiotherapy, or chemotherapy for malignancy within the past five years
6. Women of child bearing age, not using a standard accepted method of birth control
7. Pregnancy or breast feeding
8. Previous and concurrent medication affecting mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs)
9. Disease affecting connective tissue metabolism (e.g. collagenases).
10. Allergy to collagen
11. Participation in a clinical trial within the last six months
Garlic Oil As Root Filling Material in Primary Molars

The goal of this study is to test garlic oil mixed with zinc oxide as a potential root canal filling material of primary molars in children aged from four to eight years.

the study hypothesized that garlic oil mixed with zinc oxide would be the same as the gold standard filling material (metapex).

The group receiving the garlic oil with zinc oxide as root canal filling material will be compared with other similar group receiving metapex as root canal filling material in terms of clinical and radio-graphic success, and working time.

This study is a randomized clinical trial (RCT), that aims compare the clinical and radio-graphic success of garlic oil mixed with zinc oxide, used as root canal filling material in primary molars in children aged from four to eight years, with the conventional root filling material, which is metapex.

Eligibility Criteria:
Inclusion Criteria:

1. Primary second molars which are diagnosed with irreversible pulpitis, or pulp necrosis.
2. Presence of sinus tract.
3. Periapical bone swelling.
4. Continuous bleeding after amputation of the coronal pulp tissue.
5. No pulp tissue remains when the pulp chamber is accessed.
6. Pus discharges from the canal.
7. Radiographically, only primary molars with at least two-thirds of the root length.
8. Presence of inter-radicular or periapical radiolucency.

Exclusion Criteria:

1. A tooth with internal root resorption will not be included. 2. Excessive tooth mobility beyond healing. 3. Carious perforation in the pulpal flour. 4. A tooth with a pathological lesion extending to the successor's tooth germ. 5. Non-restorable primary molars.

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Observational Open Study of Polyoxidonium in Hospitalized Patients With COVID-19

The study is designed as an open observational non-comparative study of Polyoxidonium®, lyophilizate for solution for injections and topical application, 12 mg in hospitalized patients with coronavirus disease (COVID-19).

The study was planned as an observation of Polyoxidonium® administered in addition to Russian Ministry of Healthcare (MoH) guidance for standard COVID-19 treatment. Regimens have no limitations to the use of concomitant therapy. The aim of the study is to observe the safety and efficacy of Polyoxidonium®, lyophilizate for solution for injections, 12 mg in addition to complex treatment of hospitalized patients with COVID-19.

Eligibility Criteria:
Inclusion Criteria:

1. The hospitalized patient was administered Polyoxidonium, according to the instruction for medical usage in complex with Russian MoH guidance for treatment of COVID-19.
2. Verified coronavirus disease COVID-19, and at least one of the following:

   * severe disease: mechanical ventilation or oxygen supply required with blood oxygen saturation (SpO2) ≤ 94% on room air or tachypnea, respiratory rate ≥ 24 breaths per minute,
   * mild-moderate disease: SpO2 \> 94% on room air or respiratory rate \< 24 breaths per minute.
3. The patient signed an Informed Consent form for participation in this study.
4. The patient can understand all protocol requirements, perform the study procedures, and agree to all limitations specified in the protocol.
5. Male and female patients from 18 years of age.
6. Confirmed diagnosis of coronavirus disease (COVID-19): laboratory-confirmed Severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR), or other commercial or public health assay in any specimen prior to inclusion.

Exclusion Criteria:

1. Pregnancy or breastfeeding.
2. Pathological condition that the study doctor considers significant enough to prevent enrolment of this patient.
3. Participation in any clinical study within 30 days before the Informed Consent form provided.
4. Hypersensitivity and/or intolerability to any ingredient of the investigational product.
5. Acute or chronic renal failure.
Soluble Corn Fiber Effect on Bone Resorption in Post Menopausal Women

This study is designed to study the dose response effect of continuous Soluble Corn Fiber (SCF) intake over a 50 day period on bone resorption in healthy post menopausal women using the 41Calcium methodology. To further understand the dose response effect of SCF bone biomarkers will be studied.

Our hypothesis is that soluble corn fiber will reduce bone resorption in a dose dependent manner in comparison to placebo when estimated by urinary 41Calcium excretion as well as bone biomarkers of resorption.

Subjects will be dosed with 41Calcium , a long-lived radio isotope, which will become deposited in the skeleton after about 100 days. During this time subjects will collect 24 h urine monthly to monitor the decrease in 41Calcium urinary excretion. Subsequently, the baseline level of 41Calcium urinary excretion will be evaluated over a 50 day baseline period with 24 h urine collections every 10 days. Participants will then be randomized to one of three doses of soluble corn fiber (0,10,20 g/d) to be consumed in two equivalent doses per day for 50 days. Women will collect 24 h urine every 10 days. Each 50 day period will be followed by a 50 day washout period during which the subjects will continue to collect urine every 10 days.

Eligibility Criteria:
Inclusion Criteria:

* Women at least 4 years Postmenopausal

Exclusion Criteria:

* Medications affecting bone resorption
Pharmacokinetics of Different Formulations of Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ) in Japanese Healthy Male Volunteers

To assess drug drug interaction through pharmacokinetics investigation at steady state of Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ) given as three different formulations in healthy Japanese male subjects


Eligibility Criteria:
Inclusion criteria:

* Healthy Japanese male subjects age \>=20 and \<=35 years; body weight: \>=50 kg and \<=80 kg; body mass index: \>=18.0 and \<=25.0 kg/m2
* Without any clinically significant findings and complications on the basis of a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature), 12-lead electrocardiograms (ECGs), clinical laboratory tests
* Signed and dated written informed consent prior to admission to the trial in accordance with the Good Clinical Practice (GCP) and the local legislation.

Exclusion criteria:

- Any finding of the medical examination (including BP, PR and ECGs) deviating from normal and of clinical relevance.
Microbiota and Immunoassay in Women With and Without Endometriosis: a Pilot Study

Endometriosis is an estrogen-dependent chronic inflammatory disease characterized by the presence of endometrial tissue outside the uterine cavity. This pathology has a prevalence of about 5-10% in reproductive-aged women. Endometriosis therapy uses two options: surgical or medical (hormonal) but none can be considered completely resolving. Related signs and symptoms include dysmenorrhea, dyspareunia, infertility, dysuria and dyschezia. In addition to typical gynecological symptoms, gastrointestinal symptoms (bloating, nausea, constipation, diarrhea and vomiting) affect up to 90% of patients with endometriosis. Despite its high prevalence and associated morbidity, its etiology is still unclear and is thought to be multifactorial, and genetic, hormonal, environmental and immunological factors contribute to it. Several studies have shown a significant association between abnormal immune response and maintenance of disease activity in women with endometriosis.

The microbiome contains all the genetic material of microbes, including bacteria, fungi, viruses and Archaea, which live inside the host and regulate various physiological functions. The set of these bacteria, fungi, viruses and Archaea is called a microbiota. The influence of the microbiome on immunomodulation and the development of various inflammatory diseases is well established. Conversely, little is known about the presence and composition of the microbiome in the female reproductive system and its role in the development of endometriosis or other gynecological conditions. Considering the altered inflammatory state typical of endometriosis, it seems logical to postulate a potential role of the microbiome in the etiopathogenesis of this pathology. Interestingly, the microbiome affects estrogen metabolism and estrogen affects the gut microbiome. Since endometriosis is an estrogen-dependent disease, a picture of intestinal dysbiosis resulting in abnormal circulating estrogen levels could potentially contribute to the development of this disease.


Eligibility Criteria:
Inclusion Criteria:

* BMI \<30 kg / m2
* no hormonal therapy (estrogen-progestin, progestogen, GnRH analogues) in progress for at least 1 month
* the endometriosis group include women who will undergo surgery for endometriosis. The control group include women who will undergo surgery for other gynecological indications (i.e .: abdominal surgical emergencies, tubal infertility, non-endometriotic ovarian cysts) in which the presence of endometriosis will be excluded during the surgery.

Exclusion Criteria:

* hormonal therapy in progress (estrogen-progestins, progestins, GnRH analogues)
* antibiotic and / or probiotic therapy in the 8 weeks before the samples
* pregnancy
* menopausal state
* BMI ≥ 30 kg / m2
* presence of active systemic diseases, neoplasms, positive clinical history for autoimmune diseases, active vaginosis or positive history for pelvic inflammatory disease
High-dose Icotinib Treatment Beyond Progression in EGFR Mutant NSCLC

The purpose of this study is to investigate whether high-dose icotinib treatment beyond disease progression is beneficial for NSCLC patients who have EGFR mutation and who have responded to EGFR TKI.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed stage IIIB/IV NSCLC
* Investigator confirmed progression according RECIST 1.1 during previous icotinib treatment
* Patients whose tumors:

  * are EGFR mutation-positive or
  * T790M mutation-negative
* Performance status: WHO 0-2
* Measurable disease according to RECIST 1.1

  * at least one measureable lesion .if only one measureable lesion, the biological nature must be confirmed by cytology or histology
  * a single diameter of lesion could be measured by at least one of the following methods: Chest or abdominal computed tomography(CT)or magnetic resonance imaging(MRI),conventional methods of diameter at least 20mm diameter spiral CT OR at least 10mm
* ANC ≥ 1.5\*109/L, Platelets ≥ 75\*109/L, Hgb≥ 9g/dL, Alanine amino transferase ≤ 2 × Upper limit of normal (ULN), Alkaline phosphatase ≤ 2.5 × ULN (\< 5 × ULN if liver metastases), Serum Creatinine ≤ 1.5 × ULN
* Women of childbearing age must have a pregnancy test 7 days before treatment and the result were negative ,men of childbearing age: surgical sterilization or treatment during and after the end of three months to take contraceptive measures
* Patient must be able to comply with the protocol

Exclusion Criteria:

* Patient with symptomatic central nervous system metastases
* Patient has known active hepatitis B or C, or HIV infection
* Pregnant or breastfeeding.
* Patient with uncontrolled undercurrent illness or circumstances that could limit compliance with the study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR

To assess the efficacy and safety of Intravascular Lithotripsy (IVL) in subjects undergoing transfemoral TAVR in patients with severe iliac disease, prohibitive for transfemoral TAVR in patients with severe symptomatic aortic stenosis, otherwise considered for alternative access TAVR. (e.g. trans-carotid)

The goal of this post-market, prospective, observational single-arm cohort study is to assess the efficacy and safety of Intravascular Lithotripsy (IVL) in subjects undergoing transfemoral TAVR in patients with severe iliac disease, prohibitive for transfemoral TAVR in patients with severe symptomatic aortic stenosis, otherwise considered for alternative access TAVR. (e.g. trans-carotid). This is a study of patients referred to BSW The Heart Hospital, Plano for evaluation of critical aortic stenosis. Those planned to undergo TAVR, have prohibitive iliofemoral disease, and otherwise considered for alternative access, will be considered for the study. The medical devices being used are in the post-market stage as it is being used in accordance with its approved labeling, treating iliofemoral disease.

Study data will be recorded prospectively on dedicated Data Collection Forms and stored locally in a secure format. De-identified data will be uploaded for statistical analysis. IRB approval for the study will be obtained.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 90 years of age, inclusive, at the time of signing the informed consent
2. Iliofemoral disease warrants treatment, per routine guidelines (greater than 50% stenosis and heavy calcification of the iliac's).
3. Severe symptomatic aortic stenosis and undergoing a planned TAVR procedure
4. Prohibitive iliofemoral disease, as determined by the diagnostic CT abdomen and pelvis.
5. Subjects can provide written, informed consent.

Exclusion Criteria:

1. Subject is participating in another research study involving an investigational agent that has not reached the primary endpoint.
2. Subject who has contraindications to IVL
3. Subject who has contraindications or is not eligible for TAVR