cyrilzakka/clinical-trials huggingface dataset:
Optimal Pacing Rate for Cardiac Resynchronization Therapy

This is a prospective, randomized crossover study. The objective of the study is to determine if a pacing rate of 80 beats per minute (bpm) improves exercise tolerance during the 6-minute walk test. The investigators will randomly assign half of the participants to a starting rate of 60 bpm and then switch them to a rate of 80 bpm for 3 months, and vice versa.

Cardiac resynchronization therapy (CRT) after atrioventricular node (AVN) ablation for permanent atrial fibrillation (AF) has led to better outcomes in heart failure (HF) patients with reduced ejection fraction (HFrEF) and with preserved ejection fraction (HFpEF) compared to pharmacotherapy. Emerging evidence has demonstrated patients with HFpEF may benefit from a higher heart rate compared to standard heart-lowering therapies. The optimal pacing rate for CRT after AVN ablation in persistent AF and HFpEF remains unknown.

This is a prospective, randomized crossover study. The objective of the study is to determine if a pacing rate of 80 beats per minute (bpm) improves exercise tolerance during the 6-minute walk test.

The investigators will randomly assign half of the participants to a starting rate of 60 bpm and then switch them to a rate of 80 bpm for 3 months, and vice versa. Patient mortality and HF hospitalizations will be recorded at each phase. An electrocardiogram, echocardiogram, pacemaker interrogation, BNP and creatinine levels, KCCQ-12, six-minute walk test, and physical activity measure will be obtained at baseline, 3 months, and 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. History of persistent or permanent atrial fibrillation
3. Implantation of CRT or conduction system pacing in prior 3 months to 5 years of study start
4. History of intrinsic AVN block or have undergone AVN ablation in prior 3 months to 5 years of study start
5. LVEF ≥ 50%
6. N-terminal pro-B-type natriuretic peptide (NT-proBNP) \>400 pg/mL in the last 24 months
7. Clinical HF diagnosis or NYHA class II or higher
8. Able to provide informed consent

Exclusion Criteria:

1. LVEF \<50%
2. Wide QRS (greater than 150ms)
3. Isolated RV pacing
4. Severe valvular disease
5. Severe coronary artery disease as defined by one of the following:

   1. ACS or PCI within 1 year
   2. Any angina (CCS class 1+)
   3. Unrevascularizable severe CAD (\>70% stenosis in 1+ major vessels and/or based on functional assessment)
6. ESRD
7. Significant primary pulmonary disease on home oxygen
8. Major orthopedic issues, such as being wheelchair bound and/or unable to perform a six-minute walk test
9. Ventricular ectopy \>15% premature ventricular contractions (PVC)
10. End stage cancer diagnosis
11. Life expectancy less than one year
12. Palliative or hospice care
13. Hypertrophic cardiomyopathy (HCM)
14. Uncorrected ventricular septal defect
15. Infiltrative cardiomyopathy (CM)
16. Uncontrolled hypertension as defined by blood pressure \>160/100 mm Hg on two measurements ≥15 minutes apart
17. Hemoglobin \<7 g/dL
18. Age \>90 years old
19. Pregnant or intends to become pregnant
Overlooked Population at Risk for AIN.

The purpose of this study is to determine the possibility and compliance of performing anal Pap smear and Human Papilloma Virus (HPV) DNA testing on women with high grade lower genital tract dysplasia or cervical cancer and determining the prevalence of anal dysplasia in this population using a high-resolution anoscopy (HRA). In addition, it is being done to potentially develop screening, diagnostic and treatment protocol for anal dysplasia in women with high-grade lower genital tract dysplasia or cervical cancer.

Anal cancer incidence is increasing and although women compose more than half of all cases and those with HPV related lower genital tract dysplasia/malignancy have an even greater risk screening is currently not recommended. We therefore propose performing a prospective cohort study to determine the prevalence of anal dysplasia in women with high-grade lower genital tract dysplasia using high-resolution anoscopy HRA. This will then potentially lead to the development of a screening, diagnosis and treatment schema that can be implemented in all women with high-grade lower genital tract dysplasia. This study can potentially have a high impact on health delivery in women at high risk for anal cancer as this can transform the current treatment of anal cancer to a preventive screening program. This can later be implemented throughout Ontario and in all centers that treat women with cervical dysplasia.

The incidence of anal intraepithelial neoplasm (AIN also known as anal cancer) has increased in Ontario over the last 20 years. Two-thirds of the cases are found in women. The average time between diagnosis of anal cancer and previous cervical dysplasia or cancer is approximately 20 years. This study is giving the opportunity to detect and treat pre-invasive lesions and potentially prevent the development of anal cancer. Currently, no screening, diagnosis or treatment recommendation for anal dysplasia found in women with high-grade lower genital tract dysplasia.

Eligibility Criteria:
Inclusion Criteria:

* Women ≥ 40 years old
* Previous or current high grade cervical dysplasia or cervical cancer

Exclusion Criteria:

* Women ≥ 40 years old because the median time between the diagnosis of anal cancer and previous cervical cancer is approximately 20 years.
* chemotherapy or radiation therapy within the last 6 months
Health Effects of Oat and Oat Bioactive in Human

Aim of the study is to investigate health effects of oats and oat derived components, in human intervention studies, with the purpose to build new knowledge for development of cardiometabolic protective foods

The overall goal is to increase the knowledge which can be used for the development of food products with anti-diabetic properties, with the purpose to facilitate healthier food choices for people. More specifically the primary purpose of this project is to evaluate effects in healthy humans on cardiometabolic test markers of oat and oat based product. The new knowledge will form a base for the development of oat based food products with added health values.

Eligibility Criteria:
Inclusion Criteria:

* healthy adults
* BMI 18,5 - 28
* non smokers
* consuming a non-vegetarian diet that follows the Nordic guidances

Exclusion Criteria:

* Fasting blood glucose concentration \>6.1 mmol/l
* Known cardio-metabolic disease (e.g. diabetes, hypertension, metabolic syndrome), gastro-intestinal disorders such as IBS (irritable bowel syndrome) that can interfere with the study results, food allergies. Further no antibiotics or probiotics should have been consumed within 4 weeks prior to and during the study
Optimizing Strength Training in Older Adults

The objective of the current study is to determine whether lifting lighter loads close to failure improves strength training adaptations and function in older adults. The main questions it aims to answer are:

1. The effect of light loads on physical function
2. The effect of light loads on muscle mass, power, and strength

Researchers will compare a light-load, high-repetition program to a standard strength training program. Participants will perform supervised strength training twice per week for 20 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 65 years and above
* Inactive lifestyle (\< 150 min per week of moderate intensity physical activity) and not regularly participating in a structured strength training program
* Planning to reside in the area for the duration of the study

Exclusion Criteria:

* Severe cardiac disease, including Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina
* Lung disease requiring either oral or injected steroids, or the use of supplemental oxygen
* Short, portable mental status questionnaire with 3 or more errors
* Severe arthritis (either osteoarthritis or rheumatoid arthritis)
* Cancer requiring treatment in the past 1 year (melanomas excluded)
* Development of chest pain or severe shortness of breath during the 6 min self-paced walk test
* Parkinson's disease or other serious neurological disorders
* Renal disease requiring dialysis
* Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
* Current consumption of more than 14 alcoholic drinks per week
* Severe lower back or shoulder pain that may worsen with weightlifting exercises
* Undergoing physical therapy involving the lower extremities
* Living in nursing homes, assisted living facilities or other similar institutions
* Currently enrolled in another randomized trial involving a pharmaceutical or lifestyle intervention
* Weight change (intentional or not) over the last 6 months of \> 5% of body weight, or plan to lose or gain weight during the study
* Any other cardiovascular, pulmonary, orthopedic, neurologic, or other conditions that would preclude participation and successful completion of the protocol

Temporary Exclusion Criteria

A person meeting any of the following temporary exclusion criteria at the time of screening will not be enrolled but may be re-screened later.

* Severe hypertension, e.g., SBP \> 200 mm Hg, DBP \> 110 mm Hg
* Major surgery or fracture or hip/knee replacement within the last 6 months
* Hospitalization within the last 6 months (excluding ER visits)
Long-term Benefits of CPAP or MAD Treatment on the Sleep of OSAS Patients

The REMAP study aims to follow a cohort of 400 patients in around ten sleep centers in France and to collect clinical routine data. The objectives of this study are to investigate the effects of one-year management of OSA by CPAP or MAD on sleep architecture defined by objective macro and micro sleep architecture parameters using a sleep test device. sleep connected at home, to assess the quality of sleep and the quality of life reported by patients. The study will also allow us to define predictive factors for improving sleep quality during OSA treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patient already included in the SunSAS study (No. ID/RCB: 2021-A01827-34) or Patient who has undergone polygraphy or polysomnography eligible for treatment with CPAP or MAD in the context of OSA.
* Patient with a sleep test performed with the Sunrise device
* Men or Women from 18 to 80 years old
* Patient with OSAS eligible for CPAP or MAD therapy
* Affiliated patient or beneficiary of a social security scheme
* Signed informed consent

Exclusion Criteria:

* Patient previously treated for OSAS by CPAP or MAD during the last five years
* Patient with COPD or other respiratory diseases.
* Patient with contraindications to PPC or MAD therapy
* Patient with unstable heart disease or New York Heart Association class III or IV heart failure
* Patient unable to complete the study
Safety and Efficacy of Azithromycin to Treat Cutaneous Leishmaniasis

The adequate treatment of the American tegumentary leishmaniasis is crucial since the disease, differently from the caused by the Old World species, is painful and not self-healing and may lead to the disfiguring mucosal involvement. So far, pentavalent antimony compounds have been considered the treatment of choice for cutaneous leishmaniasis (CL), however, these drugs present high frequency of side effects and important disadvantages as parenteral administration and need for careful renal and cardiac monitoring. Azithromycin is a macrolide antibiotic, non-expensive, largely commercially available that has shown in-vitro and in vivo activity against different species of Leishmania.

The main objective of this study is to evaluate the efficacy and safety of oral azithromycin for the treatment of CL. The efficacy of oral treatment of azithromycin 500 mg/day for 20 days is going to be compared with the standard treatment of intramuscular injections of 20 mg/Kg/day of pentavalent antimonials (Glucantime®) for 20 days in patients with CL from two endemic regions of Brazil: the metropolitan region of Belo Horizonte and Montes Claros (MG)in the southeast Brazil and in Corte de Pedras (Bahia), Northeastern Brazil. The patients follow up lasts for 12 months.

Included a new site (University Estadual de Montes Claros - UNIMONTES) in 7 June 2010. The site was included due the need to achieve more patients. The ANVISA (National Agency of Sanitary Surveillance) approved these site in March 2011 and the start of activities is planned for June 2011.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 14 and younger than 65 years old
* Skin lesions with clinical suggestion of cutaneous leishmaniasis and positive leishmanin skin test(Montenegro test)or parasitological (direct observation of leishmania amastigotes, leishmania in vitro culture from aspirates, histopathological) and molecular(Polymerase Chain Reaction - PCR)samples.
* No use of oral potentially antileishmanial drugs, or topics throughout the term of the current injury.
* Absence of disseminated leishmaniasis.
* Absence of mucosal involvement.
* Agreement to participate in the study and signed the informed consent.

Exclusion Criteria:

* Diabetes mellitus, kidney diseases, liver or cardiac diseases, tuberculosis, malaria.
* Pregnancy
* lactating mothers
* Breast feeding
* Cutaneous lesion with bacterial infection for which antibiotics need to be prescribed
* More than six cutaneous lesions
* Previous history of cutaneous or mucosal leishmaniasis
* Use of drugs with potential pharmacological interactions with antimonials as anti-arrhythmic or tricycle anti-depressives
* Previous intolerance to azithromycin or other macrolides or N-methylglucamine
* Abusive alcohol ingestion according to the CAGE questionnaire
Traditional Chinese Medicine in Individualized Treatment of Patients With Diabetes Symptoms

Based on the Individualized treatment of diabetes symptoms to evaluate the method of syndrome differentiation treatment of Traditional Chinese medicine.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed type 2 diabetes poorly controlled by diet and exercise therapy, and must with any of diabetes symptoms.
* After the diet and exercise therapy, 7.0mmol/l≤FPG≤11.1mmol/l or 8.0mmol/l\<2h PG\<16mmol/l
* Any type of TCM syndrome, but can be performed within the chosen Chinese herbal medicine.
* Subject is willing to participate and capable of giving informed consent.

Exclusion Criteria:

* Those patients used any drugs for treatment of diabetes within one month.
* Patients with any severe complications of cardiac, cerebric, vascular, hepatic, renal, blood system.
* Patients suffer from acute metabolic disorder including diabetic ketoacidosis or hyperosmotic non-ketotic coma within one month.
* Women who were pregnant, lactating or planned pregnant.
* Allergic constitution and has a history of drug allergy.
* Combined with severe acute or chronic infections.
Evaluation of End of Life Quality of Care

The study uses a mixed method study to evaluate wether the use of the indicators of the Quality of end-of-life cancer care, developed by Earle et al \[Earle JCO 2003; DOI: 10.1200/JCO.2003.03.059\] would be relevant and measurable in France. The qualitative part of study was designed to investigate the representations of quality by face-to face interviews with family carer of recently deceased cancer patients, and with their oncologists, and nurses. The quantitative part of the study, consisted in a decedents case series analysis, diagnosed with advanced cancer and followed up in 5 centers. Data on trajectory of care were collected from different complementary sources associating national mortality data, hospital activity data, and health records.

The study was approved by the French data protection authority (CNIL) number 611273.


Eligibility Criteria:
Inclusion criteria

* Patients aged ≥ 18,
* diagnosed with advanced cancer (recruited from hospital activity data, by a stay with a ICD code of metastatic cancer between Oct 1st, 2009 and Dec 31, 2010)
* deceased between, Jan 1st, 2010 and Dec 31, 2010 (vital status identified either from hospital activity data, or from national mortality statistics)

Exclusion Criteria:

* diagnosis with non solid tumor (haematology)
* age \< 18
Safety of the PET-512MC Transesophageal Transducer

The objective of this Study is to demonstrate the safety of the PET-512MC TEE transducer as it is inserted and transitioned into the esophagus through the mouth.

The PET-512MC is a multiplane transesophageal transducer designed for use with Toshiba Diagnostic Ultrasound Systems for the visualization of the heart (and other organs) as a real-time ultrasound image. It is inserted into the esophagus through the mouth to visualize a plane of the heart through the esophageal wall.

The purpose of this Study is to demonstrate the safety of the PET-512MC TEE transducer and gather feedback from the investigators related to the insertion of the transducer. The data will be used to determine the usability of the transducer in the clinical environment.

Eligibility Criteria:
Inclusion Criteria:

* Adult male and female patients ages 18 and above who have been scheduled for a TEE procedure by their physician
* Informed consent understood and signed
* Compliance with post-treatment and follow-up protocol requirements

Exclusion Criteria

* None
Effect of Yoga on Postpartum Depression

This study was conducted to investigate the effect of yoga on postpartum depression. Subjects: Forty primipara women with postpartum depression (PPD) selected randomly from Kasr El Ainy University Hospital in Cairo complaining of postpartum depression at least one month after childbirth shared in this study.

This study was conducted to investigate the effect of yoga on postpartum depression. Subjects: Forty primipara women with postpartum depression (PPD) selected randomly from Kasr El Ainy University Hospital in Cairo complaining of postpartum depression at least one month after childbirth shared in this study. Group A (Control group): It consisted of 20 women and treated by antidepressant drugs only for 12 weeks. Group B (Study group): It consisted of 20 women and treated by the same antidepressant drugs as in group A and yoga program, 50 minutes daily,7 days per week for 12 weeks (Total 84 sessions).

Eligibility Criteria:
Inclusion Criteria:

* Their ages were ranged from 20-35 years
* Their body mass index was less than 30 kg/m2

Exclusion Criteria:

* cardiac arrhythmia,
* respiratory problems,
* uncontrolled Type I diabetes
Phase II Trial of Sunitinib in BAC or Never-Smokers With Any Lung Adenocarcinoma

This is an open-label study of a new oral drug for advanced stage (IIIB or IV) lung cancer. The cancer must be EITHER bronchoalveolar carcinoma (BAC) type, or if the patient is a never-smoker (less than 100 cigarettes lifetime) the cancer can be any type of adenocarcinoma.

To participate in this study, patients must have disease that can be measured on a CT scan. Brain metastases are OK if stable. Pregnant and/or nursing women may not participate. This drug has been approved by the FDA for the treatment of advanced renal cell cancer and a certain type of stomach/intestinal cancer. Its efficacy in lung cancer in currently unknown. Common side effects include fatigue, nausea, diarrhea, skin reaction, and decreased blood counts.

Eligibility Criteria:
Inclusion Criteria:

* Bronchoalveolar carcinoma with disease measurable on CAT scan
* Any lung adenocarcinoma in a never-smoker (less than 100 cigarettes lifetime) with disease measurable on CAT scan
* Stage IIIB or IV

Exclusion Criteria:

* Uncontrolled hypertension
* Unstable brain metastases
* Pregnant/nursing women
* Uncontrolled thyroid disease
Short Term Outcomes of Laparoscopic Intraperitoneal Onlay Mesh With Facial Repair(IPOM-plus) for Ventral Hernia.

entral hernias are a major cause of functional impairment, abdominal pain, and bowel obstruction. The overall incidence of primary ventral hernia is estimated to be between 4 and 5 % in the literature, and ventral incisional hernia rates vary from 35 to 60 % within 5 years after laparotomy . After laparoscopy, this rate is estimated to decline from 0.5 to 15 % even after two decades, LVHR or open repair (OVHR) is still a matter of debate because of concerns about seroma formation, recurrence rate, and the intraperitoneal mesh position. . The laparoscopic technique for repairing ventral and incisional hernias is now well established. However, several issues related to LVHR, such as the high recurrence rate of hernias with large fascial defects and in extremely obese patients, are yet to be resolved. Additional problems include seroma formation. To solve these problems, laparoscopic fascial defect closure with IPOM reinforcement (IPOM-Plus) has been introduced in the past decade, and a few studies have reported satisfactory outcomes. Although detailed techniques for fascial defect closure and handling of the mesh have been published, standardized techniques are yet to be established.


Eligibility Criteria:
Inclusion Criteria:

* patients over 18 years undergoing surgery for primary or incisional ventral hernia
* defect whose major axis not exceeding 12cm.

Exclusion Criteria:

* Patients undergoing revision
* Emergency surgery.
* Parastomal hernias were not included.
* Patients not candidate for laparoscopy including cardiac and COPD patients
The Effect of Adalimumab on the Bone Microstructure in Crohn's Disease (CD) Patients

The investigators will study the effect of Adalimumab on the bone microstructure.

* Trial with medicinal product


Eligibility Criteria:
Inclusion criteria:

* CDAI \> 220 und \< 450
* Biologika naiv
* CD seit \> 6 Monaten

Exclusion criteria:

* other TNF-Blocker
* Steroids \> 40 mg
* Malignoma in der Anamnesis