cyrilzakka/clinical-trials huggingface dataset:
Pulmonary Veins Circular Ablation Catheter Evaluation for Atrial Fibrillation

The aim of this study is to compare two type of ablation catheters for pulmonary veins isolation (PVI) in subjects with atrial fibrillation.

Currently, two technologies of irrigated ablation catheters are available for PVI.

One of the two, the "conventional" catheter is widely used for atrial fibrillation (AF) treatment but has not been specifically created for pulmonary veins isolation, therefore, point by point encircling lesions are cumbersome and time consuming.

The second is a new ablation catheter with a circular shape provided with 10 irrigated electrodes designed to create encircling lesions, necessary to obtain pulmonary veins isolation, could allow an easier and faster isolation compared to the conventional way.

These two types of catheters have never been compared for atrial fibrillation. If one of the two catheters appears to be more efficient or causes fewer complications, the use of this catheter could be favored to conduct AF ablation.


Eligibility Criteria:
Inclusion Criteria:

* Subject with atrial fibrillation refractory to anti-arrhythmic drugs, with episodes lasting less than 7 days and eligible for atrial fibrillation ablation.
* Age superior or equal to 18 years old, both genders.
* Patient's oral agreement for study participation after reading information note.
* Patient affiliated or recipient of a social welfare regimen.

Exclusion Criteria:

* Age inferior to 18 years old
* Pregnancy
* Unbalanced psychiatric disorders
* Contraindication to atrial fibrillation ablation by endocardial way.
* Redo-ablation
* No patient's oral agreement for study participation
Trial to Evaluate the Efficacy and Safety of HCP1302

Trial to Evaluate the Efficacy and Safety of HCP1302

A Randomized, Double-blind, Multicenter, Phase Ⅲ study to Evaluate the Efficacy and Safety of HCP1302 in Both Erectile Dysfunction and Hypertension Patients being Treated with HGP0904

Eligibility Criteria:
At Visit1

1. ≥19 age
2. Hypertension Patients who need amlodipine 5mg
3. Abnormal Erectile function ≥ at least 3months based on screening date
4. Patients who are expected to frequent use of Tadalafil (at least two times for weeks)
5. Patients understood the consents and purpose of this trial and signed informed consent form

At Visit2

1. 90≤ sitSBP \< 140 mmHg and 50 ≤ sitDBP \< 90 mmHg
2. Sexual dysfunction rate ≥ 50% for 4 weeks run-in period
3. International Index of Erectile Function(IIEF)- Erectile Function(EF) domain score ≤ 25

Exclusion Criteria:

1. History of hypersensitivity to Amlodipine or Tadalafil
2. Has a severe liver disorder(Child-Pugh Class C) or liver enzyme (AST, ALT) level exceeds 3 times more than normal upper range
3. Has a clinically significant renal failure (Scr \> 2mg/dl)
4. Uncontrolled diabetes mellitus (HbA1C \>12%)
5. At screening date, blood pressure gap of selected arms is sitSBP ≥20mmHg or sitDBP ≥10mmHg
6. Taking PDE-5 inhibitors or other therapeutic agents for Erectile Dysfunction within 7 days based on screening date
7. No reaction to PDE-5 inhibitors
Grip&Health: Behavioural Intervention to Reduce Smoking, Stress and Improve Financial Health in Low-SES in Rotterdam

Grip\&Health: randomised trial which will examine the effect of theory-based multicomponent behavioural intervention for reducing stress, smoking and improving financial health and perceived health of low-SES residents in Rotterdam. Between January 2018 and July 2018, a total of 300 participants will be recruited and randomised either to a stress management program (SM), stress management with a buddy program (SM-B) or a control condition. The investigators hypothesise that compared to participants in the control condition, participants in the intervention arms will demonstrate reduced stress, reduced smoking and improved financial health and perceived health.


Eligibility Criteria:
Inclusion Criteria:

* perceive stress
* smoke
* poor financial health

Exclusion Criteria:

* follow other stress management course
* follow smoking cessation course
* receive help from debt services for their financial problems
* have health problems which hamper their ability to take part in the study
Midodrine in the Recovery Phase of Septic Shock

The aim of this study is to investigate the role of oral midodrine in the recovery of septic shock. The investigators hypothesize that the oral drug can reduce central line days and ICU length of stay.

The investigators aim to investigate the use of midodrine in the recovery phase of septic shock in a randomized control trial. The investigators hypothesize that midodrine use initiated after stabilization or improving intravenous vasopressor requirement will lead to decreased length of ICU stay and length of time that intravenous vasopressors are required.

The investigators plan to enroll and consent patients at the onset of septic shock. Once IV vasopressor requirement is stabilized or decreasing, males and females will be randomized in 1:1 fashion to receive either standard clinical care or standard clinical care plus oral midodrine. The investigators will analyze length of stay in the ICU, time on vasopressors, time needing a central line, and hospital length of stay.

Eligibility Criteria:
Inclusion Criteria:

* • Patients aged 18-99 years old

  * Admitted to UVA medical ICU with diagnosis of septic shock.

Exclusion Criteria:

* Pregnant females, patients with childbearing potential will have urine pregnancy testing after consent
* Patients \< 18 years
* Prisoners
* Patients already taking midodrine
* Patients with cirrhosis and Child-Pugh Class C (Child-Pugh score \> 9)_
* Patients with Increased intraocular pressure and glaucoma
* Patients with allergy to midodrine
* Non-English speaking patients
* Patients without enteral access
* Patients where the attending physician does not feel MAP goal of \> 65 mmHg is physiologically acceptable.
Sitagliptin/Metformin Fed Bioequivalence Study (0431A-080)

This study will demonstrate the bioequivalence of metformin after single dose administration of sitagliptin/metformin 50/500 mg fixed dose combination (FDC) tablet and concomitant administration of single doses of sitagliptin 50 mg and metformin 500 mg as individual tablets after consumption of a high-fat meal.


Eligibility Criteria:
Inclusion Criteria:

* is in good health
* is a nonsmoker
* is willing to follow all study guidelines

Exclusion Criteria:

* has or has a history of any illness or condition that might confound the results of the study or make participation unsafe for the participant
* is a nursing mother
* is unwilling to consume the required high-fat breakfast
The Effect of Neuromuscular and Vestibulo-Ocular Training on Balance,Isokinetic Strength and Proprioception in Chronic Ankle Instability

The aim of the study is to compare the effects of neromuscular exercise combined with vestibulo-ocular reflex training on balance,isokinetic muscle strength and proprioception in subjects with ankle instability.The aim of the study is to compare the effects of neromuscular exercise combined with vestibulo-ocular reflex training on balance and isokinetic muscle strength in subjects with ankle instability.

Hypotheses of the study; H0: Vestibulo-ocular reflex training protocol, which is given in addition to the neuromuscular exercise program, has an effect on isokinetic ankle muscle strength and balance in individuals with ankle instability.

H1: Vestibulo-ocular reflex training protocol, which is given in addition to the neuromuscular exercise program, has no effect on isokinetic ankle muscle strength and balance in individuals with ankle instability.

The aim of the study is to compare the effects of neromuscular exercise combined with vestibulo-ocular reflex training on balance,isokinetic muscle strength and proprioception in subjects with ankle instability. This study was conducted in Sportomed Athlete Health and Orthopedic Rehabilitation clinic in February 2020, September 2022.A total of 20 participants aged 18-30 were included in the study on a voluntary basis..Participants were randomly seperated to 2 groups. Demographic information and informed consent forms were filled into all subjects who volunteered to participate in the study and in accordance with the research criteria. After the evaluation, the subjects in the first group were included in the vestibulo-ocular exercise program in addition to the neuromuscular exercise programs with the same physiotherapist. Subjects in the second group were included in neuromuscular training programs. The trainings were applied three days a week for four weeks and each training session lasted approximately 60 minutes. Functional limitations of the participants before and after the treatment were evaluated with the Foot and Ankle Ability Measure Daily Living Subscale (FAAM-ADL) and Sports Subscale (FAAM-S). Dynamic balance evaluation with star excursion balance test, proprioception evaluation by measuring joint position sense with goniometer, and ankle evertor and inverter concentric muscle strength were evaluated using isokinetic dynamometer at angular velocities of 60/s, 120/s and 180/s, and the results were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Being 18-30 years old
* At least 2 lateral sprains to the same ankle in the past
* At least 1 episode of "giving way" that had occurred within the past 6 months
* The presence of residual symptoms during functional activities and had to be free from symptoms of any other previous injury to the lower extremity.
* No other injuries to the lower limbs

Exclusion Criteria:

* Having a bilateral ankle instability
* Having a history of ankle fracture
* Having a history of fracture or surgery to the involved lower extremity
* Having a history of balance and vestibular disorders
Adherence of Beta Thalssemia Patients to Oral Chelation Therapy

The β-thalassemias are a group of inherited disorders of hemoglobin (Hb) synthesis characterized by chronic anemia of varying severity. The degree of anemia relies on several genetic and environmental factors and determines the need for regular transfusion therapy. It is now common practice to classify patients as having transfusion dependent β-thalassemia (TDT) or non-transfusion-dependent β-thalassemia (NTDT). Regarding geographical distribution of β-thalassemia, it prevails more in countries on the Mediterranean, South east of Asia and in the east of Europe. In Egypt, it is the most common cause of chronic blood loss: One thousand cases are recorded annually for every 1.5 million live births the disease prevalence is equal to1000 cases per 1.5 million live births (Ghazala et al., 2021).

The only curative treatment for thalassemia currently is a bone marrow transplant. However, it is restricted to only a few patients due to the non-availability of an HLA-matched donor and high cost. Thus, most patients receive regular blood transfusions accompanied by iron chelation therapy (ICT) as the standard of care. The ideal management of a patient with transfusion-dependent thalassemia (TDT) requires a multidisciplinary therapeutic approach. The main iron chelating agents include deferoxamine (DFO), deferiprone (DFP), and deferasirox (DFX). Due to poor oral bioavailibility, DFO is the only chelator that must be administered subcutaneously or intravenously up to once a day; DFP and DFX may be administered orally up to three times a day. The known side effects associated with each chelator include infusion reactions in DFO, gastrointestinal distress, agranulocytosis in DFP, and transaminitis in DFP and DFX.


Eligibility Criteria:
Inclusion Criteria:

1. confirmed diagnosis of beta thalassemia major or intermedia,
2. Age between 2-18 years,
3. Receiving regular blood transfusions every 2-5 weeks
4. Prescribed oral iron chelation therapy with deferasirox for at least 1 year prior to enrollment.

Exclusion Criteria:

1. Age less than 2 years and more than 18 years
2. Any cause of blood transfusion other than beta Thalassemia
3. Patients on deferoxamine
Use of Ketamine in Severe Pain Syndromes

Ketamine has been shown to have a certain efficiency in chronic pain syndromes. However, it is still not clearly known what is its efficiency and how ketamine is used in real world patients. In this retrospective study, all patients treated with ketamine for chronic pain in our hospital will be reviewed. Patients demographics, pain syndromes as well as outcome criteria will be collected to describe the use of ketamine in pain syndromes.

The American Society of Regional Anesthesia and Pain Medicine, together with the American Academy of Pain and the American Society of Anesthesiologists published a consensus guideline in 2018 on the use of ketamine in chronic pain. A review of medical charts of all patients who received ketamine for chronic pain between january 2010 and june 2024 will be done. Demographic data, detailed pain scores, as well as description of the type of pain will be collected. Ketamine usage will be recorded for the dosage, as well as duration of the treatment. Outcome will be measured by before/after pain scores for neuropathic pain, as well as on a visual analog scale. A more global score (good-medium-no effect) will also be collected to get the patient's impression on their treatment. Concomitant pain medication will be collected.

Eligibility Criteria:
Inclusion Criteria:

- All patients who received ketamine as treatment for a pain syndrome during january 2010 until june 2024 at Erasme University Hospital

Exclusion Criteria:

* Age \< 18 years
* Patients who expressed their opposition to the use of their medical data
* incomplete medical chart
Peri-operative Tamsulosin and Impact on Voiding Trial After Same-day Urogynecology Surgery

The purpose of this research study is to determine if taking tamsulosin preoperatively decreases your chances of being discharged after surgery with a Foley catheter (flexible tube that drains urine from the bladder into a collection bag).


Eligibility Criteria:
Inclusion Criteria:

- Patients undergoing any pelvic organ prolapse repair or incontinence surgery

Exclusion Criteria:

* Any surgery involving a non-urogynecologist
* Patients already on an alpha blocker
* Baseline hypotension
* History of syncope
* Postural orthostatic tachycardia syndrome (POTS)
* Non-English speaker or interpreter unavailable for Spanish-speaking patient
* Impaired cognition impeding proper consenting
* Any other medical contraindication for tamsulosin use
* History of urinary retention requiring continuous or intermittent catheterization
* Patients consented for the study but then due to intraoperative complication, routine voiding trial no longer indicated due to requiring indwelling catheter or intermittent catheterization on discharge will be excluded from primary outcome analysis
* Pregnancy
Tight Caloric Balance in Geriatric Patients

The aim of this study to assess the impact of nutritional support guided by repeated measurements of REE in geriatric patients following surgery for hip fractures.

Our hypothesis is that tight caloric control will reduce the risk of significant postoperative complications in geriatric patients following surgery for hip fractures.

Study Design :Prospective, Single center, Randomized, Unblinded study. Study Population:geriatric patients following surgery for hip fractures.

The primary outcome:

presence of postoperative complications,hospital length of stay.

Secondary outcomes:

energy intake and calculated energy balance

Study Procedure:

eligible patients will be randomly assigned to 2 groups: the tight calorie (intervention)group and the control group.

Eligibility Criteria:
Inclusion Criteria:

patients older than 65 years who were admitted to the unit following hip fracture within 48 hours of the injury and in whom orthopedic surgery was considered the treatment of choice.

Exclusion Criteria:

Patients were excluded if they presented to hospital \> 48 hours after the injury, were receiving steroids and/or immunosuppression therapy; in the presence of active oncologic disease, multiple fractures, diagnosed dementia or in the event that patients required supplemental nasal oxygen which precludes the measurement of resting energy expenditure.
Characterization of Gut Microbiota Composition and Activity After a Daily Supplementation of 4.5 g/Day of ChitinGlucan Fibre During 3 Weeks in At-cardiometabolic Risk Volunteers

The aim of this study is to demonstrate the beneficial effects on gut microbiota composition and activity of the diary intake of insoluble fiber (extract from Aspergillus Niger) for three weeks. The first studies about the fiber have shown a favorable gut microbiota modulation and an improvement of metabolic parameters like LDL cholesterol. In addition to fecal measurements, several biomarkers of colic fermentation will be assessed: expired gases, PolyUnsaturated Fatty Acid, Short Chain Fatty Acid (SCFA) after a rich-fiber breakfast (= 15 grams) and a nutritional challenge test at lunch. The gastrointestinal tolerance of fiber intake and the intestinal transit modification will be also followed during all the study.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Non-smokers
* Body mass index between 25 and 35 kg/m2
* Waist circumference \< 80cm for women and \> 94 cm for men
* Fiber intake \<25g/day

Exclusion Criteria:

* Medical history of digestive surgery or disease
* Current or recent (\<12 weeks) intake of antibiotics or gastro-intestinal medicinal product
* Current probiotics, prebiotics, fiber complement, and/or any products modulation gut transit
* Feeding particular diet such as vegetarian diet or hyperprotein diet
* Current weight loss diet
* Pregnant or lactating woman or woman who did not use effective contraception
* Drinking more than 3 glasses of alcohol per day (\>30g/day)
A Study of LY2835219 in Healthy Participants

Participants in this study will receive 3 single oral doses of LY2835219 at least 14 days apart. One dose will be given with a standard meal, one dose with a high-fat meal and one dose without food. The study will evaluate the effects of the standard and high-fat meals on how much drug gets into the bloodstream. Side effects will be documented. This study is approximately 43 days, not including screening. Screening is required within 28 days prior to the start of the study.


Eligibility Criteria:
Inclusion Criteria:

* Healthy sterile males or surgically sterile or postmenopausal females
* Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m\^2), inclusive, at screening
* Are able to eat a high-fat, high-calorie meal

Exclusion Criteria:

* Participated in a clinical trial involving investigational product within 30 days
* Abnormal blood pressure
* Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
* Have donated blood of more than 500 milliliter (mL) within the last month
* Show evidence of human immunodeficiency virus, hepatitis B or hepatitis C
Comparative Study to Assess the Ongoing Pregnancy Rate for Poor Responders Women Undergoing Different Embryo Transfer Protocols

Published data on sequential transfer are limited and are not consistent. Also, further research into methods of risk combination and assessment, would allow us to help our patients make better-informed decisions about whether or not to proceed with invasive diagnostic tests as the PGS. So our study aims to describe the ongoing pregnancy rate for poor responders women undergoing four different embryo transfer protocols among four arms within the study. Moreover, to describe the miscarriage rate, and the baseline characteristics for the same population. This clinical study will be conducted in compliance with the clinical study protocol and applicable regulatory requirements.

The study aims to describe the ongoing pregnancy rate for poor responders women undergoing four different embryo transfer protocols among four arms within the study. Moreover, to describe the miscarriage rate, and the baseline characteristics for the same population. This clinical study will be conducted in compliance with the clinical study protocol and applicable regulatory requirements.

This study is prospective, comparative, open label and multi-center study. The study participants' relevant medical records will be collected and reviewed after obtaining informed consent for the participants.

The study materials that will be used will include blood tests, and ultrasound. The study will involve four study arms:

Arm 1: Poor responders women undergoing frozen sequential embryo transfer on Day 3 and Day 5 Arm 2: Poor responders women undergoing sequential fresh embryo transfer on Day 3 and Day 5 Arm 3: Poor responders women undergoing sequential embryo transfer on Day 3 and Day 5 after performing PGS Arm 4: Poor responders women undergoing conventional frozen embryo transfer on Day 5

Primary and secondary key measurements will be used in the study.

The primary measures will include:

* Presence of intrauterine gestational sac at 12 weeks beyond embryo transfer
* Presence of fetal heart pulsation at 12 weeks beyond embryo transfer

The secondary key measures will include:

* Occurance of abortion between week 7 and week 20 of gestation
* Recording the the baseline characteristics of the study participants

Eligibility Criteria:
Inclusion Criteria:

1. The age group of these women is 25-45 years
2. Normal endometrial cavity confirmed by hysteroscopy
3. Poor responders with AMH \<1
4. Patients with at least grade 1 days 3 embryo and grade 1 day 5 frozen embryos

Exclusion Criteria:

1. Patients with any immunological disorders
2. Patients with uncontrolled systemic diseases
3. Patients with previous uterine surgeries except for Cesarean section
Offering Nicotine Patches to All Households in a Municipality With High Smoking Rates

One municipality with high smoking rates will be selected. A coupon for free-of-charge nicotine patches will be sent to each household. Reductions in the number of people smoking in the chosen municipality from before to after the NRT distribution will be estimated

A coupon offering five weeks of free nicotine patches will be mailed to every household in a small municipality with elevated smoking rates. Up to 800 participants (one per household) will be able to redeem their coupon online or by phone, and receive nicotine patches via postal mail. Participants will be asked to complete a baseline survey containing items relevant to predicting smoking cessation. Participants will be asked to complete a six-month follow-up survey to assess changes in smoking status.

Research Question: Will the concentrated distribution of nicotine patches in a region of high smoking rates lead to large reductions in smoking rates?

Eligibility Criteria:
Inclusion Criteria:

* speak and understand English
* 18 years or older
* smoke 10 or more cigarettes per day for at least 3 months

Exclusion Criteria:

* health contraindications for using nicotine patches without supervision of a doctor (e.g. allergy to tape, pregnant or intending to become pregnant, currently breastfeeding, serious heart or circulation problems not including high blood pressure)