cyrilzakka/clinical-trials huggingface dataset:
Prevention of Atrial Fibrillation by Optimized Overdrive Stimulation

Evaluation of dynamic Atrial Overdrive Stimulation using the AF Suppression Algorithm to prevent atrial tachyarrhythmias in patients with more than 2% Auto Mode Switch Episodes with optimized pacemaker programming.

Hypothesis:

Dynamic atrial Overdrive (AF Suppression) reduces AT/AF Burden by 30% as compared to programming DDDR-(60) without AF Suppression when all other parameters are optimized.

Atrial Fibrillation is the most common Heart Rhythm Disorder requiring therapy.

Eligibility Criteria:
Inclusion Criteria:

* indication for dual chamber pacemaker
* documented paroxysmal or persistent Atrial Fibrillation
* P-wave \>1.0 mV in Sinus Rhythm or sufficient detection of AFib
* stable antyarrhythmic therapy
* age \>= 19 years
* written informed consent
* implantation of a Identity DR 5370/5376 or later
* bipolar atrial lead

Exclusion Criteria:

* permanent AFib
* reversible etiology of AFib
* HYHA II or IV
* Coronary Artery disease with stable angina pectoris
* implanted ICD or planned implantation of a ICD
* cardiac surgery within the last 6 months or planned within 12 months
* live expectancy \< 12 months
* pregnancy
Early Detection of Graft-Versus-Host Disease in Patients Undergoing a Donor Bone Marrow Transplant

RATIONALE: Studying samples of blood in the laboratory from patients who have undergone a donor bone marrow transplant may help doctors learn more about changes that occur in DNA and identify biomarkers related to graft-versus-host disease. It may also help doctors predict how patients will respond to a donor bone marrow transplant.

PURPOSE: This laboratory study is looking at early detection of graft-versus-host disease in patients undergoing a donor bone marrow transplant.

OBJECTIVES:

Primary

* Identify detectable changes in the transcriptomic or proteomic expression prior to clinical manifestations of graft-versus-host disease (GVHD) in blood samples from at-risk patients who have undergone allogeneic bone marrow transplantation.

Secondary

* Characterize changes in the transcriptome or proteome expression pattern which are predictive of clinically significant GVHD in these patients.
* Develop reliable tests which enable early intervention for these patients.

OUTLINE: Blood samples are collected prior to and just after typical onset of clinical graft-vs-host disease (GVHD) on days 1, 7-10, 20-23, 30-33, and 60 after allogeneic bone marrow transplantation. RNA is quantified and assessed by microarray analysis to identify changes to transcriptome or proteome expression and markers predictive of the onset of clinical GVHD. Samples are also stored for future analysis.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Any patient undergoing an allogeneic bone marrow transplantation at one of the participating Mayo Clinic sites

PATIENT CHARACTERISTICS:

* Body weight ≥ 15 kg
* Not pregnant
* Not a prisoner

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Intraoperative Fluorescence of Ganglogliomas and Neuroepithelial Dysembryoplastic Tumors

One of the key issues of tumour brain surgeries is to clearly define the borders of the tumor. The investigators proposed to evaluate the feasibility of intraoperative fluorescein guidance. Patients will be identified from the list of patients operated on under fluorescence to collect clinical datas. Surgical videos will be analyzed to assess the presence of intraoperative fluorescence and its subjectively judged intensity. MRI data will be extracted from the radiological reports to assess quality extraction. No additional data will be produced

Gangliogliomas typically present as a slow-growing, cystic mass taking contrast, while dysembryoplastic neuro-epithelial tumors commonly show microcystic patterns, inconstant contrast-enhancement and are preferentially located on the internal face of the temporal lobe. The cornerstone of the treatment of these two entities remains surgery, as it provides good oncological outcomes and control of seizures. Surgical resection keeps a major role for these tumors. Thus, one of the key issues is to clearly define the borders of the tumor during surgery, a point of considerable importance for these curable lesions. Then, the investigators proposed to evaluate the feasibility of intraoperative fluorescein guidance, a technique based on the staining of blood-brain barrier breakdown areas with fluorescein. Patients will be identified from the list of patients operated on under fluorescence maintained by the department since the acquisition of the technique. Clinical datas will be collected and surgical videos will be analyzed to assess the presence of intraoperative fluorescence and its subjectively judged intensity (absent, weak, medium, strong). MRI data (quality of excision: total, subtotal or partial according to usual criteria) will be extracted from the radiological reports. No additional data will be produced

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old patient
* Fluoroguided removal of a histologically proven Ganglioglioma or Dysembryoplastic Neuroepithelial Tumors between 2015-2018
* Surgical video available

Exclusion Criteria:

* Absence of surgical video
* Adults who are subject to legal protection (protection of justice, guardianship, guardianship)
* Patient objecting to the use of their data
Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)

This registry is performed for the long-term assessment of outcome, performance and residual safety aspects of the BIOMONITOR III and possible successors in a real-life clinical set-up. In addition, this registry is set up in a way that it may also be used as a platform for submodules to investigate additional scientific and regulatory aspects while minimizing the additional effort for the investigational sites and patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient is intended to receive a BIOTRONIK Implantable Cardiac Monitor (ICM)
* Patient is able to understand the nature of the registry and to provide written informed consent.
* Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept.

Exclusion Criteria:

* Patient is pregnant or breast feeding.
* Patient is less than 18 years old.
* Patient is participating in another interventional clinical investigation other than the submodules of BIO\|STREAM.ICM
Assessment of QoL and Outcomes With SBRT for RCC

Stereotactic body radiotherapy (SBRT) is an emerging radiotherapy technique that precisely delivers high doses of radiation to tumours. It has been investigated as definitive treatment for an increasing variety of primary tumours including lung, liver, prostate, and now renal cell carcinoma (RCC). The principal aims of this study are to prospectively assess quality of life (QoL) and oncologic outcomes in non-surgical patients who receive SBRT for the treatment of RCC.

There is an evolving body of literature that shows high rates of tumour control and minimal associated toxicities with SBRT to treat RCC. However, the majority of published evidence is retrospective in nature, and there is a scarcity of data on the impact on quality of life and cost-effectiveness of kidney SBRT.

The principal aims of this multicentre study are to prospectively assess QoL and oncologic outcomes in non-surgical patients who receive SBRT for the treatment of primary renal cell carcinoma.

The study population will include 30 consecutive patients treated with kidney SBRT on a conventional linear accelerator (35-40 Gy in 5 fractions) at the Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto (OCC) and the Juravinski Cancer Center, Hamilton Health Sciences Centre, McMaster University (JCC).

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years old
* Medically inoperable or patient who refuses surgery
* Histologic diagnosis of RCC where possible, or radiologic evidence of growth on surveillance
* Lesion ≥2.5cm or recurrent lesion following local ablative therapy
* Written informed consent
* Participants must be able to understand the English-language or with the aid of a translator

Exclusion Criteria:

* ECOG ≥3
* Prior abdominal radiation
Effect of Supplemental Oxygen on Maximal Oxygen Consumption in Patients With Chronic Obstructive Pulmonary Disease

Maximal consumption of oxygen (VO2max) during exercise is used in patients with chronic obstructive pulmonary disease (COPD) to stratify perioperative risk. However, the impact of supplemental oxygen to prevent hypoxemia during exercise on maximal oxygen consumption and other ventilatory parameters during maximal exercise in the resting normoxic Chronic Obstructive Pulmonary Disease population is poorly defined. The investigators performed a randomized controlled trial in patients with COPD who underwent cardiopulmonary exercise tests on room air and supplemental oxygen. The investigators compared maximal oxygen consumption and other ventilatory parameters in each individual subject under the two conditions.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Chronic Obstructive Pulmonary Disease (COPD).
* Pulmonary function characterized by forced expiratory volume in 1 second/forced vital capacity ratio\<0.7, and forced expiratory volume in one second \<80% predicted.

Exclusion Criteria:

* Subjects with a recent COPD exacerbation requiring emergency department visit or hospitalization within the last month.
* Subjects scheduled for a major pulmonary intervention in the next 3 months
* Subjects with severe peripheral vascular disease or other physical conditions that would preclude exercise testing
Wich is the Best Dressing in Wounds by Primary Surgery of THA and / or TKA?

Surgical wounds are covered to prevent bleeding, absorb the exudates and provide a barrier against external contamination. Currently, in Corporació PT after orthopedic surgery, traditional occlusive dressing of sterile gauze and non-woven hypoallergenic adhesive tape is placed. In many cases the appearance of blistering caused by the use of these conventional dressings is observed, which increases the risk of infection, pain and the final cost of the procedure. There are other types of dressings that could improve these aspects but comparative data are not currently available. Main objective: to identify the dressing that better preserves the integrity of the skin.

Design: Prospective randomized comparative study of 5 types of dressings used in total knee and hip arthroplasty surgical wounds (TKA and THA).

Secondary Objectives: To identify the dressing that provides greater advantages and minor inconveniences in TKA and THA surgery.

Study population: Patients older than 18 years undergoing fast track primary TKA or THA. 110 patients


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* operated on primary TKA and THA in the fast track circuit
* adequate cognitive ability.

Exclusion Criteria:

* damaged skin
* no self-care capacity or caregiver
* inadequate cognitive ability to consent freely
* patients who will not undergo "fast track" surgery
Telithromycin in Acute Exacerbation of Chronic Bronchitis

Study objectives:

* to document the clinical efficacy of telithromycin(800 mg per day for 5 days) at Test Of the Cure (TOC)visit (D12-D19), in acute exacerbation of chronic bronchitis.
* to assess the long-term clinical efficacy of telithromycin by telephone at D25-D35 (V3)
* to assess the safety of telithromycin


Eligibility Criteria:
Inclusion Criteria:

* Outpatients,
* With a documented history of chronic bronchitis defined by one expectoration daily for at least three consecutive months over at least two consecutive years
* Presenting with an evident acute exacerbation of their disease defined by the presence of at least two of Anthonisen's criteria:

  * exacerbation of dyspnea,
  * increase in the expectoration volume,
  * increase in the expectoration purulence,

Exclusion Criteria:

* Acute bronchitis,
* Chronic obstructive pulmonary disease, those having FEV1 value \<35% (FEV1: Forced Expiratory Volume in 1 second)
* Suspected pneumonia or bronchial pneumonia,
* Paroxysmal asthma or continuous dyspnea in asthma,
* Cystic fibrosis,
* Active tuberculosis,
* Lung cancer or lung metastasis,
* Severe bronchiectasia,
* Acute respiratory decompensation,
* Chronic respiratory insufficiency associated with resting hypoxemia,
* Patients requiring hospitalization for parenteral antibiotic treatment
* Patients with suspected or known bacterial infection other than study diseases, as well as associated systemic or intra-tracheal antibiotic treatment other than study treatment,
* Participating in another clinical study with any product within 30 days before the inclusion of study
* Known immunosuppression (AIDS and/or CD4+ lymphocytes \< 200/mm3, neutropenia \<1500/mm3, blood diseases or terminal stage cancer)
* Cardiovasculary, neurologic or other severe diseases interfering with the compliance with study protocol or confusing with results.

Conditions associated with study medications:

* Hypersensitivity against telithromycin , macrolides or any of the excipients,
* Congenital long QT syndrome or family history of congenital long QT syndrome (this possibility should be excluded with normal ECG) or known acquired QT interval prolongation,
* Treatment with CYP3A4 inducers (rifampicin, carbamazepine, phenytoin, phenobarbital, St-John's-wort) within 2 weeks prior to the study inclusion
* Possibility of treatment with ergot alkaloid derivatives, terfenadine, astemizole, pimozide, cisapride, simvastatin, athorvastatin or lovastatin during studies
* Congenital galactosemia, lactase deficiency glucose or galactose malabsorption syndrome,
* Pregnant or lactating women,
* Women with childbearing potential (e.g. ovulating, pre-menopausal or not surgically sterilized) and do not employ any effective contraception method The patients may not participate to the study more than once. The patients who were treated with study drugs previously may not participate to the study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Covered Metallic Stent and Benign Colonic Strictures

Self-expanding metallic stent placement is a safe and effective endoscopic procedure increasingly used to relieve colonic obstruction. Fully covered metal stents (FCSEMS) and plastic stents have been recently developed to reduce both hyperplastic (non tumoral) and tumoral tissue ingrowth. These fully covered metal or plastic stents have several advantages over non-covered stents, including the possibility of retrieval and limited local tissue reaction, while providing alleviation of obstruction at possibly lower costs. Only few reports of fully covered metal stent placement in patients with benign colorectal strictures are available in the literature. The aim of this study was to assess the effectiveness of FCSEMS in the management of the colonic benign strictures.

It is a national multicentric retrospective study on the use of fully covered metal stent placement in patients with benign colorectal strictures.

Consecutive patients above 18 years of age with a symptomatic benign colonic stricture despite optimal medical and/or endoscopic dilation therapy and which required the use of a FCSEMS were included. All strictures were confirmed to be benign by histology. All details concerning previous history, origins and treatment (medical or endoscopic) of the colonic stenosis were collected from the medical file.

Senior endoscopists with an experience of more than 50 colonic stent placements performed the procedure under general propofol-induced anesthesia with the same technic (The stent was placed under fluoroscopic and videoendoscopic controls).

Patients were required after the procedure to take oral osmotic laxatives regularly. Post-stenting complications were defined as immediate (during the procedure), early (occurring ≤ 30 days) and late (\> 30 days) after the procedure. Stent removal and routine follow up endoscopy were scheduled 4 to 6 weeks after placement in most patients or earlier if complications occurred.

All patients were followed up at regular intervals based on their clinical situation. A retrospective chart review was performed to analyze the long-term outcome of the patients.

Eligibility Criteria:
Inclusion Criteria:

* patients above 18 years of age
* symptomatic benign colonic stricture despite optimal medical and/or endoscopic dilation therapy

Exclusion Criteria:

* Previous insertion or treatment of the stricture with metallic (covered or uncovered) stent
Soft and Hard Tissue Changes Around the New Lance® Implants Using Traditional and Switch Platform Abutments

The purpose of this present study is to compare alveolar bone changes and markers of gingival health around the new Lanes® dental implant which were rehabilitate using the new switch platform abutment ( SPR ) and the traditional ( CPK ) abutment.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patient aged 18 - 80 yrs.
2. Implants treatment planned for single crown rehabilitation.
3. Submerged implant placement.
4. Patients willing to participate in a twelve month study.
5. Up to 2 implants per patient will be allowed.

Exclusion Criteria:

1. Active periodontal disease.
2. Systemic condition and medication that may affect soft and hard tissue healing.
3. Pregnancy or intention to become pregnant in the next twelve months.
4. Parafunctional occlusal scheme and habits.
Short-course Preoperative Chemoradiotherapy for Rectal Cancer

The purpose of this study is to evaluate the early clinical outcome of the short-course preoperative chemoradiotherapy, 33Gy/10 fx and delayed operation after chemoradiation, the investigators initiated the clinical trial of KROG 11-02.


Eligibility Criteria:
Inclusion Criteria:

1. histologically confirmed adenocarcinoma
2. distal margin of the tumor located \< 8 cm above the anal verge
3. cT3-4 or cN+ classification as determined by endorectal ultrasonography (EUS) and CT
4. patient older than age 18 years
5. Karnofsky performance score \>= 70

Exclusion Criteria:

1. distant metastasis identified during staging workup
2. previous or concurrent malignancy
3. pregnant or breast-feeding women
4. impending rectal obstruction
5. familial adenomatous polyposis
Internet-based Cognitive-behavior Therapy for Children With Obsessive-compulsive Disorder

The purpose of this study is to evaluate the feasibility and effectiveness of Internet-delivered Cognitive Behavior Therapy (ICBT) for children (7-11 years) with Obsessive-Compulsive Disorder (OCD).

The primary objective of this study is to investigate if Internet-delivered Cognitive Behavior Therapy (ICBT) is a feasible and effective treatment for children (7-11 years) with Obsessive-Compulsive Disorder (OCD). The design of the study is a pilot study with 16 participants. The treatment duration is 12 weeks. The primary outcome measure is the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS). Study participants will be followed up 3 months after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Primary DSM-5 diagnosis of OCD
* Total score of ≥16 on the Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)
* Age between 7-11 years
* Ability to understand Swedish
* Daily access to the Internet
* A parent that can co-participate in the treatment
* Participants on psychotropic medication must had been on a stable dose for the last 6 weeks prior to baseline assessment

Exclusion Criteria:

* Diagnosed autism spectrum disorder, psychosis, bipolar disorder, severe eating disorder, organic brain disorder, learning disability
* Suicidal ideation
* Not able to understand the basics of the ICBT self-help material
* Have completed a course of CBT for OCD within last 12 months (defined as at least 5 sessions CBT including exposure and response prevention)
* On-going psychological treatment for OCD or another anxiety disorder
Flaxseed Lignan (Brevail)

PCOS is a disorder which is characterized by hyperandrogenism (high serum male hormone levels), ovulatory dysfunction, and polycystic ovaries (multiple follicles-over 12- in the ovary). There is no universally accepted definition for PCOS. The Rotterdam criteria require 2 of 3 criteria for diagnosis, including hyperandrogenism (clinical hirsutism or serum hormone measurement), oligomenorrhea/amenorrhea, and ultrasound findings of polycystic ovaries.

This study is a prospective randomized pilot study designed to evaluate the effects of flaxseed supplementation (with Brevail) on hormonal and lipid metabolism balance in polycystic ovarian syndrome (PCOS) patients.


Eligibility Criteria:
Inclusion Criteria:

* Must be 18 to 40 year old female with:
* Diagnosis of PCOS by menstrual irregularity (fewer than 9 menses annually/interval over 40 days), Ferriman-Galleway score \>8, and/or hyperandrogenemia defined as total testosterone \>80ng/dl or bioavailable testosterone \>8.4 ng/dl.
* Mentally competent.

Exclusion Criteria:

* Use of oral contraceptives, spironolactone, or insulin-sensitizing agents within the past 2 months.
* Long-term or chronic use of oral antibiotics.
* Hysterectomy.
* FSH \>15.
* Pregnancy/lactation.
* Consumption of flaxseed within the last month.
* Diagnosis of thyroid disease, nonclassical adrenal hyperplasia, and hyperprolactinemia.
* Use of any dietary fiber supplements which are newly started (within the past 6 months) and agreement not to use any new fiber supplements during the study period.
Inpatient Smoking Cessation Pilot Program

The investigators are implementing a stepwise approach to cessation with a public health focus to improve health outcomes for the investigators' pediatric patients. The investigators are focusing on addressing caregiver smoking as a modifiable risk factor during time of child's hospitalization as a window of opportunity to provide counseling and education to families on secondhand and third hand smoke exposure as well as information on NRT products to heighten caregiver contemplation for quitting. One of the central goals of the investigators' project is to increase immediate access to Nicotine Replacement Therapy (NRT) resources for families during hospitalization which pediatric providers could potentially dose and prescribe to caregivers who are screened positive for smoking. Long-term cessation care is provided by referrals to both the MD Quitline and the John Hopkins Tobacco Treatment Clinic. Both are provided to allow participants options that the participants would find preferable from an insurance and provider perspective.


Eligibility Criteria:
Inclusion Criteria:

* Caregivers of patients on an inpatient unit at Johns Hopkins Children's Center who self-identify as tobacco users and wish to initiate tobacco cessation

Exclusion Criteria:

* Pregnant or breast feeding maternal caregivers.