cyrilzakka/clinical-trials huggingface dataset:
Combined Effect of Continuous and Interval in Addition to Tadalafil Drug on Erectile Dysfunction

Erectile dysfunction (ED) is the persistent inability to attain and maintain a sufficient erection to permit satisfactory sexual performance. ED, a condition closely related to cardiovascular morbidity and mortality, is frequently associated with obesity. The importance of reducing cardiovascular risk factors remains fundamental to the overall vascular good health of the man, and that includes sexual vascular health. ED shares similar modifiable risks factors with coronary artery disease (CAD). Lifestyle modification that targets CAD risk factors may also lead to improvement in ED.

Sixty obese men with ED complaints will be divided to two groups, exercised and non-exercised groups; n= 30 patients in every group. Both groups will receive five milligrams of tadalafil one time per day for 8 weeks but the exercised group only will receive - in addition to tadalafil - combined continuous and interval aerobic training, 3 session weekly for 8 weeks after detecting their target heart rate via the cardiopulmonary exercise test.

Eligibility Criteria:
Inclusion Criteria:

1. Sixty sedentary obese married men with BMI \> 30 kg/m2.
2. The age of participants will range from 40-50 years old.
3. Blood pressure will be \< 140/90 mm Hg.
4. The patients who will have ED at least from 6 months with IIEF-5 score \< 22.

Exclusion Criteria:

1. Alcoholic, smoker, hypertensive, diabetic, and addicted patients.
2. Patients with pulmonary, renal, hepatic, and cardiac disorders.
3. Lower limb arthritis or orthopaedic disorders that will hinder the training program.
4. Prostatic inflammation, hyperplasia, and tumors.
5. Participation in a structured sport program in the previous 6 months.
6. previous pelvic and genital surgeries.
Health Benefits of Functional Meat (With n-3 Fatty Acids and Rosemary Extract) on Low Risk for Cardiovascular Disease People

Volunteers were randomly assigned by gender to follow of two 12 weeks experimental periods: intervention (I) and control (C) in different order (I/C or C/I). Both periods were separated by a 4 weeks wash-out interval during which subjects returned to their usual diet:

During the I period, volunteers weekly consumed three 150g/serving Functional Meat (FM) products (cooked Ham and Turkey breast). It was firmly recommended that all other meats and meat derivatives had to be excluded from the diet.

During the C period, volunteers consumed identical amounts of meat products that did not include functional ingredients (Control Meat (CM)).

Functional meat (FM) products (Functional cooked Ham (FH) and Functional cooked Turkey breast (FT)), were manufactured mixing the meats with the patented formula® (P200402755.2004). The amount of supercritical rosemary extract, deodorized salmon oil and vitamin E used was respectively, 0.02% w/w, 0.6% w/w, and 0.001% w/w.

Control meat (CM) products (Control cooked Ham (CH) and Control cooked Turkey (CT), were prepared without addition of the functional ingredients.

The total duration of the study was 28 weeks: first experimental period 0-12 weeks, washout period 12-16 weeks second experimental period 16-28 weeks:

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged over 18 years
* At least 2 lipid profile parameters altered (TAG ≥150 mg /dl and/or total cholesterol ≥200 mg / dl and/or LDL ≥130 mg / dl and/or HDL ≥40mg/dl men or ≥ 50mg/dl women).
* Signed informed consent

Exclusion Criteria:

* Individuals with body mass index (BMI) ≥ 35 kg/m2
* Individuals with Diabetes Mellitus insulin dependent
* Individuals with disorders associated with eating behaviour
* Individuals with consumption of omega 3 functional foods, fish oil or antioxidant supplements
* Individuals inability to consume the test foods (ej. Vegetarians)
* Individuals with special diet due to disease as celiac disease, chronic renal failure, etc.
* Individuals with mental disease or low cognitive function.
* Individuals with consumption of drugs to weight lost.
* Individuals treated with drugs whose direct effect is on lipid profile (statins, fibrates, diuretics, corticosteroids or oral anti-inflammatory).
* Individuals with diseases that could be involucrate in weight lost (not controlled hypothyroidism, serious psychiatric illness, etc.).
* Pregnant women or lactating.
* Individuals with regular consumption of anti-inflammatory or glucocorticoids.
System to Evaluate the Risk of Lymph Node Metastasis Preoperatively in Cervical Cancer

The lymph node status is difficult to be assessed preoperatively, this study aimed to develop a scoring system for predicting the risk of LNM in cervical cancer patients before operation.

Lymph nodes metastasis (LNM) was proved to be a critical risk factor related to the survival to cervical cancer survival. However, preoperative pelvic magnetic resonance imaging (MR) or computed tomography (CT) tests are less sensitive to assess the risk of lymph node metastasis. PET-CT is too expensive and radiative to be widely used in clinical practice. A model was constructed based on clinical indicators to predict lymph node metastasis preoperatively, providing a reference for clinical treatment.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of cervical cancer
* FIGO stage IB1-IIA1
* Undergone radical hysterectomy with pelvic lymphadenectomy
* Peformed pelvic MRI examination preoperatively

Exclusion Criteria:

* Had distant metastases diagnosed before or during the surgery
* Underwent neoadjuvant radiotherapy preoperatively
* Underwent neoadjuvant chemotherapy preoperatively
* Incomplete or inaccuratemedical records
Assessment of Blood Pressure Control and Target Organ Damage in Patients With Chronic Kidney Disease and Hypertension -II

The purpose of this study is to find the change of blood pressure (BP) control pattern (true controlled, white-coat, masked, and sustained uncontrolled/ dipper, non-dipper, reverse-dipper, and extreme-dipper) in patients with chronic kidney disease (CKD) over 3 years. And Other objective is the relationship between the BP control pattern and the target organ damages such as renal function, proteinuria, left ventricular hypertrophy (LVH), and so on. In addition, we will find clinical factors related to the BP control pattern.


Eligibility Criteria:
Inclusion Criteria:

1. with informed consent
2. 20 \<= age \< 75 years
3. diagnosed as hypertension 6 months (or 3 visits) prior to enrollment, taking anti-hypertensive drugs over 3 months
4. all-cause chronic kidney disease patients with 15 \<= estimated GFR \< 90
5. no change of anti-hypertensive drugs within 2 weeks and good compliance

Exclusion Criteria:

1. changed prescription according to ambulatory blood pressure monitoring (ABPM) regularly
2. had acute kidney injury/hospitalization
3. had a proteinuria of \> 6 g/day (spot urine protein to creatinine ratio \> 6.0 g/g Cr)
4. had end stage renal disease (ESRD) with dialysis and/or were a kidney recipient
5. had diseases, such as uncontrolled arrhythmia, uncontrolled bronchial asthma/chronic obstructive pulmonary disease, or primary endocrinologic diseases except diabetes mellitus
6. were pregnant/lactating women
7. were night shift workers.
A Study to Evaluate the Safety, Tolerability, and Fecal Pharmacokinetics of BX002-A in Healthy Adults

The purpose of study BMX-02-001 is to evaluate the safety, tolerability and feasibility of orally administered BX002-A to deliver viable bacteriophages to the gut.

Study BMX-02-001 is a randomized, single-blind, placebo-controlled study to evaluate the safety, tolerability, and feasibility of orally administered BX002-A to deliver viable phages that can be measured in the stool.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults 18-65 years old
2. Able to understand study procedures and sign informed consent

Exclusion Criteria:

1. Evidence or history of clinically significant underlying conditions
2. Women who are pregnant or nursing, or plan to become pregnant during study, or women of childbearing potential not using adequate contraceptive measures
3. History of constipation, severe diarrhea and/or loose stools within 14 days
4. History of procedures aimed at modifying the gastrointestinal microbiota within past year (e.g., fecal microbiota transplantation)
5. Topical gastrointestinal treatment (e.g., enemas) in the 2 weeks prior or planned during study
6. Use of bowel cleansing or preparation in the 4 weeks prior or planned during study
7. Participation in another investigational trial within 30 days
8. Known allergy or hypersensitivity to an excipient in the study drug or placebo
9. Any other reason which according to investigator may impact proper study conduct
10. History of alcohol abuse; drug or medication abuse or tobacco use
11. Subject who cannot be contacted in case of emergency
Movement Patterns in Young Volleyball Athletes

This project is a consequence of the research chair project studying the same phenomenon in adult volleyball players. The project will make use of and be part of the routine medical screening that is taken by the young players of the first degree of the Leuven Volleyball School, Belgium. All young players must undergo a routine medical investigation and movement screening. This is obliged by the law. The current project will use these data. Outcome parameters will be used to advice the trainer staff of the school to adjust their training interventions. This is normal routine too as the involved medical department has been advising the school for many years. Players will be followed up for 6 weeks. After those 6 weeks, the movement screening will be repeated to evaluate the change in the different outcome parameters. This last screening is not part of a normal routine as players normally are investigated more in a subjective way. The medical team and school want to change that routine.

Data will be used to further improve training modalities and sports performance and reduce injury risk in these young athletes.


Eligibility Criteria:
Inclusion Criteria:

* All students from the first degree of the Volleyball school will participate
* Male and female athletes will be included
* Signing of an informed consent and assent form (for young kids) to use data for research
* Agreement given by the medical staff to use data and allowing the kids to be accepted by the school

Exclusion Criteria:

* When inclusion criteria are not met
Indocyanine Green (ICG) Guided Sentinel Lymph Node Mapping for Pediatric Visceral Solid Tumors

The purpose of the study is to find out the usefulness and safety of a dye called Indocyanine Green (ICG for short). This dye will be used to help the surgeon find lymph nodes draining solid tumors inside the abdomen that need to be removed. This may also help the surgeon to find if the cancer has moved to other lymph nodes outside of the known area.

Primary Objectives

* To determine the percentage of patients in whom Indocyanine Green (ICG)-guided sentinel lymph node (SLN) mapping was successful at the time of retroperitoneal lymph node dissection for staging of visceral solid tumors.
* To determine the percentage of patients with grade 3 or higher adverse events related to ICG use.

During surgery, participants will be given the dye to help the doctor see the lymph nodes to be removed. Pictures or a video of the procedure will be done. The number of lymph nodes removed will be recorded. After surgery, the lymph nodes will be examined.

Participants will be followed for up to 24 hours after surgery to determine if there were any side effects from the dye.

Eligibility Criteria:
Inclusion Criteria:

* Any patient under the age of 21 years with visceral pediatric solid tumor suspected to be Wilms tumor or para-testicular rhabdomyosarcoma requiring retroperitoneal lymph node dissection.

Exclusion Criteria:

* Subjects with a history of iodide allergies.
* Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
* Pregnant female.
* Patients with extensive prior surgery at the primary site or nodal basin expected to affect the lymphatic drainage.
Fed-Fasted, Single and Multiple Ascending Dose Trial of XEN-D0103

This study is an evaluation of the safety and tolerability of XEN-D0103 in healthy subjects. Part 1 assesses the safety, tolerability and blood levels of the ascending single doses of XEN-D0103. Blood levels of XEN-D0103 will be assessed when administered with food and also without food in Part 2. The safety, tolerability and blood levels of XEN-D0103 will be assessed following dosing for 10 days in Part 3.


Eligibility Criteria:
Inclusion Criteria:

* For Parts 1 and 3 healthy, male subjects aged 18 to 45 years, inclusive. For Part 2 healthy, male and female subjects aged 45 to 65 years, inclusive.
* Females must be of non-childbearing potential

Exclusion Criteria:

* Subject has a known heart disease.
* Subject has any of QTcF \> 450 msec, PR ≥ 210 msec or QRS ≥ 120 msec at screening (determined from median of three readings).
* For Part 1 only: subject has resting heart rate outside of the range 45 to 80 beats per minute (bpm) at screening (determined from median of three readings).
* Subject has any other condition which, in the investigator's opinion will interfere with the trial.
* Subject has a systolic blood pressure (BP) \<80 or \>160 mmHg at screening or a diastolic BP \>90 or \<45 mmHg at screening.
* Subject has a clinically significant abnormal laboratory test result at screening.
* Female subject who is pregnant or breast feeding and female subjects of childbearing potential.
Innovative Stratification of Arrhythmic Risk (ISAR-Trial): Long-Term Prediction

The purpose of this study is to investigate the performance of established and new risk preditors in predicting long term-mortality (up to ten years) of post-infarction patients.


Eligibility Criteria:
Inclusion Criteria:

acute myocardial infarction

Exclusion Criteria:
Accidental Reactions in Peanut/Tree Nut Allergic Children

Food allergy is an immune reaction, triggered by food protein allergens, of varying severity, from mild local reaction to life threatening anaphylaxis and fatalities.

Peanut is a plant from the botanical family of the Fabaceae, more commonly known as legumes. The prevalence of peanut and tree nut allergy is increasing. In France (ELFE cohort), it is estimated to 0.93%. The tree nuts include mainly almond, hazelnut, pistachio, cashew nut, walnut, pecan nut and Brazil nut. Allergy's prevalence is estimated to 0.54% in children up to 5.5 years. Peanut allergy is a main cause of anaphylaxis and deaths due to food allergy.

Recurrence of food allergy is a main concern. The risk has been estimated to 10% per year for peanut.

In France, Data in real-life on the rate of recurrence of allergic reactions and anaphylaxis to peanut/tree-nut as well as risk factors, are lacking.

The objective of this study is to assess the frequency of allergic reaction to peanut and tree-nuts, to describe the reactions' characteristics and risk factors.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed allergy to peanuts and/or nuts

Exclusion Criteria:

* Other chronic diseases, except allergic comorbidities (asthma, rhinitis, atopic dermatitis, other food allergy)
Measurement of Cut-off Perfusion Index Value in Infraclavicular Blocks

To investigate the value of the cut-off perfusion index showing that the block is successful in infraclavicular blocks performed under ultrasound guidance.

In upper extremity procedures, ultrasound (US) guided infraclavicular block is a frequently used approach. Today, the frequency of studies on the perfusion index (PI), which can be used as a criterion in the evaluation of block success, is increasing. The aim of this study is to evaluate the success and effectiveness of infraclavicular approach block with perfusion index using ROC (Receiver Operating Characteristic) curves.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1-2 PATIENTS
* PATIENTS BETWEEN 18-65 YEARS
* PATIENTS WITH INFRACLAVICULAR BLOCK

Exclusion Criteria:

* ASA3-4 PATIENTS
* PATIENTS UNDER THE AGE OF 18, PATIENTS OVER 65
* PATIENTS WHO DO NOT WANT TO BE INCLUDED IN THE STUDY
* PATIENTS WITH CONTRAINDICATION TO INFRACLAVICULAR BLOCK
* PATIENTS WITHOUT COOPERATION
* PATIENTS WITH DIABETES MELLITUS
* THOSE WHO HAVE PERIPHERAL ARTERY DISEASE
ICSI Outcome of Ejaculated Versus Extracted Testicular Spermatozoa

The study is retrospective to compare ICSI outcome of patients with cryptozoospermia or severe oligozoospermia after use of ejaculated versus extracted testicular sperms in different cycles for the same patient.

The study was carried out on couples who underwent ICSI in period 2012-2014 for male factor infertility.Patients with semen showing cryptozoospermia were candidates for inclusion in this study.

First cycle was done as ICSI with priority to ejaculated sperm; testicular sperm was used if no motile sperm was available. For failed cases a second cycle was repeated using either testicular sperm or ejaculated sperm.

Keywords:Cryptozoospermia, ejaculated spermatozoa, testicular spermatozoa, ICSI.

Eligibility Criteria:
Inclusion Criteria:

* Couples seeking ICSI.

Exclusion Criteria:

* Couples not seeking ICSI.
Effect of tDCS Along With Relaxation Technique on Anxiety Level in Students Preparing for Competitive Exams

Anxiety is one of the most significant obstacles to academic success. When stress is interpreted negatively or becomes overwhelming, it causes anxiety before and during examinations, which in turn impacts students' academic performance. The difficulty in managing severely associated anxiousness enhances the demand for NIBS. It is a unique approach that has the potential to alleviate anxiety by modifying cortical excitability whereas Relaxation breaks the vicious cycle of pain caused by muscular stress, circulatory illness, and metabolic by-products alterations. The main purpose is to evaluate whether tDCS along with Relaxation technique reduces the anxiety level in competitive exam students. Total 46 students are recruited and randomly allocating in experimental and control group. The subjects in the experimental group are going to receive 9 tDCS sessions (2mA, anode placed on the DLFPC of left side and cathode on right supraorbital cortex for 20 min) along with relaxation technique. Subjects in the control group are going to receive 9 sessions of relaxation. The CSAI-2R scale is used as an Outcome Measure. Samples completed the CSAI-2R scale before and following the intervention. The data will be analyzed using SPSS 26.0 software.


Eligibility Criteria:
Inclusion Criteria: • Both male and female students.

* Competitive Exam students only.
* Age group between 15 years to 18 years.
* Willingness to take part in the research.

Exclusion Criteria: • Seizure disorder

* Non-Corporative students
* Skin irritation
Teen and Young Adult Connections for Support From Multidisciplinary Professionals & Peers

12 month study testing mobile delivery of health information and connections to professionals and peers to improve health of teen/young adult HPN users.

This research study will test the effect of in-home/mobile HPN support delivered to teen and young adult home parenteral nutrition (HPN) patients and family members over handheld personal computers. Effects on health status, QoL, and fatigue will be assessed over time between groups of study subjects from the ages of 13 through 30 randomized to one of two groups. Group One (intervention group) will receive mConnect, integrated evidence-based interventions (skill-building games, restorative naps \& peer support) via mobile iPad and Internet delivery plus two real-time audiovisual encrypted connections with multidisciplinary professionals and peers. Group Two (control group) will receive healthy activity information via mobile iPad and Internet delivery plus one real-time audiovisual encrypted connection with professionals and peers.

Eligibility Criteria:
Inclusion Criteria:

* Total parenteral nutrition (TPN) patients/users and family members/caregivers (defined as those individuals involved in daily home HPN care) age 13 and older
* TPN users (also called HPN users) ages 13 through 30 must be receiving intravenous nutrition for a non-malignant short bowel disorder
* Read, write, speak English and provide informed consent
* Be able to participate in group clinic visits

Exclusion Criteria:

* Enteral nutrition dependency only
* Less than 13 years of age
* 13 through 17 years of age without parental consent
* Currently enrolled in an intervention study or HPN management program
* Severe cognitive impairment
* Disability disorders (e.g. blindness which cannot be accommodated for active participation in the group clinics
Interventional Study Exploring the Occurrence of Surgical Site Infections.

Interventional study exploring surgical site complication occurrences in high-risk revision patients undergoing TKA or THA using NPWT.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent
2. Patient ≥ 18 years
3. Elective unilateral revision THA or TKA.
4. High risk patients for surgical wound complications as deemed by investigators
5. Primary closure technique by suture or staples
6. Linear or curvilinear incisions ≤ 25 cm in length
7. The patient able to understand the study and is willing to consent to the clinical investigation
8. Patients able to understand how to operate with the negative pressure system at home

Exclusion Criteria:

1. The need for emergency surgery
2. Multiple Incision Approach at the time of surgery (alternative approach from primary surgery using 1 incision is permitted)
3. Patients requiring bilateral revision total hip or knee arthroplasty surgery
4. Active infections of the offending joint.
5. History of multiple infections in the offending joint
6. Patients with known allergies to product components (silicone adhesives and polyurethane films (direct contact with wound), acrylic adhesives (direct contact with skin), polyethylene fabrics and superabsorbent powders (polyacrylates) (within the dressing)
7. Subjects with contraindications (as per the Avance Solo Instructions for use)
8. Pregnant, breastfeeding females, or females of childbearing potential not willing to use contraception for the duration of the investigation
9. Patients with presence of remote skin infection or active systemic infection at the time of revision surgery.
10. Patient with incisions \> 25cm in length or type of incisions that cannot be sufficiently covered by Avance Solo Border dressing (i.e., the wound pad does not overlap the edges of the incision by at least 1.5 cm as per the IFU)
11. Use of surgical glue as part of incisional closure method
12. Patients who in the opinion of the investigator may not complete or comply with follow up treatment for any reason
13. Patients participating in ongoing clinical investigations, or during the past 30 days, that may impact the outcome of this investigation based on the judgement of the investigator.
14. Any clinically significant condition that, in the investigator's opinion, would significantly impair the subject's ability to comply with the study