cyrilzakka/clinical-trials huggingface dataset:
The Impact of the Distribution of Adipose Tissue on the Occurrence of Metabolic Disorders and the Level of Cardiopulmonary Fitness

The aim of the research was to assess the impact of the distribution of abdominal fat (subcutaneous SAT and visceral VAT estimated at the height of the navel) on selected metabolic parameters and on specific parameters of cardiopulmonary fitness in terms of people with obesity.

The research was carried out in 3 stages. Stage 1 was carried out at the Department of Dietetics and Clinical Nutrition of the UMB. During the visit, the subjects were provided with detailed information concerning the research and every participant signed a voluntary consent to participate in the research. Furthermore, an interview questionnaire concerning the duration of obesity and past diseases was collected, and an assessment of the status of nutrition based on anthropometric measurements was carried out, and a body composition analysis was performed using the bioelectroimpedance method using the Maltron BioScan 920-2 analyzer. Then, patients were issued a referral for laboratory examinations. Stage 2 was carried out at the Medical Laboratory at the University Clinical Hospital in Bialystok, where blood was taken from the ulnar vein (in the amount of 15ml). The concentrations of the following parameters were determined from the blood serum: fasting glucose, fasting insulin, total cholesterol, LDL cholesterol fraction, HDL cholesterol fraction, triglycerides, C-reactive protein (CRP), uric acid, creatinine, and aminotrasferases: alanine (ALT) and aspartate (AST). On the basis of fasting glucose and fasting insulin, the HOMA - IR insulin resistance index was calculated. Stage 3 was carried out at the Maniac Gym Fitness Club in Bialystok, where cardiopulmonary fitness was assessed using the Modified Bruce protocol.

Eligibility Criteria:
Inclusion Criteria:

* primary obesity
* BMI ≥ 30kg/m2 - ≤ 39,99 kg/m2
* gender: women and men
* age: 20-65 lat

Exclusion Criteria:

* secondry obesity
* BMI ≥ 40 kg/m2
* diabetes type 2 or insulin resistance (occurance or treatment)
* endocrine disorders
* eating disorders
* hormonal contraception/hormone replacement therapy
* after steroid therapy
* antiretroviral therapy
* musculoskeletal dysfunctions
* patients after surgery (min 3 months)
* bariatric surgery
* coronary artery disease
* cardiac pacemaker
* pregnancy
* breast - feeding
Food Interaction Study on the Pharmacokinetics of Eurartesim™ (DHA and PQP)in Healthy Male Adult Volunteers

The study was designed to assess the effect of food on the extent and rate of absorption of Dihydroartemisinin (DHA) and Piperaquine Phosphate (PQP) administered as a fixed dose combination (Eurartesim™).


Eligibility Criteria:
Inclusion Criteria:

* Caucasian healthy males aged between 18 and 50 years(inclusive).
* Body Mass Index (BMI) between 19.0 kg/m2 and 27.0 kg/m2 inclusive, with a minimum body weight of 75 kg.
* Agreed to use two approved methods of contraception from Screening and until 90 days after administration of the study drug
* Had given written informed consent to participate in this study in accordance with local regulations.

Exclusion Criteria:

* Had received or was anticipated to receive a prescription medication within 14 days prior to the start of dosing or an over-the-counter medicine 48 hours prior to the start of dosing.
* Abnormal laboratory test results deemed clinically significant by the Medical Officer.
* Positive urine drug test (e.g. opiates and cannabinoids) or alcohol breath test.
* History of significant drug allergies or significant allergic reaction.
* Receipt of blood or blood products, or loss or donation of 450 mL or more of blood within 90 days before the first dose administration.
Evaluation of the Prevalence and Clinical Manifestation of SARS-CoV-2 Infection in a Population of Adult and Pediatric Patients With Congenital Heart Disease

The goal of this observational study, drug-free, cross-sectional, single-center is to describe the incidence and characteristics of the clinical course and any short- and medium-term complications of patients with congenital heart disease of medical interest, and pediatric patients with cardiomyopathy, arrhythmic pathology or pulmonary arterial hypertension who have been affected by Sars-Cov-2 disease. The secondary objective of the study is to identify risk factors for the development of moderate-severe forms of COVID-19 disease in the study population.

This is an observational, drug-free, cross-sectional, single-centre study. All patients followed at our centre and suffering from congenital heart disease treated with only haemodynamic procedures haemodynamic procedures alone, as well as paediatric patients suffering from cardiomyopathy, pulmonary hypertension or arrhythmic pathology whose follow-up was still in progress at the time of the start of the pandemic (due to death or for reasonsof the patient). The structural collection of data necessary for the evaluation of targets will take place through the creation of a specific electronic archive, in which census of all patients who have undergone follow-up at our centre since 01/01/2005 at the time of study approval and still in follow-up at the time of the start of the pandemic.

Patients of all ages will be enrolled age, both paediatric and adult, followed at our centre. It is estimated to include in the study approximately 5000 patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients of all ages with congenital heart disease undergoing hemodynamic procedures at our center or in natural history
* Pediatric patients with cardiomyopathy, arrhythmic disease, or hypertension pulmonary
* Obtaining informed consent
* Patients who have access to an e-mail address and a computer to complete the questionnaire

Exclusion Criteria:

* Patients with congenital heart disease undergoing corrective or palliative surgical treatment
The Effect of Temporal Muscle Suspension of Temporal Hollowing

The primary objective is to identify which patients undergoing a traditional pterional approach with 2 different surgical techniques for TMS (Temporal Muscle Suspension) will develop TH (Temporal Hollowing. Pre and post-operative CT scans will be reviewed and analysis with previously proven metrics will be performed.

The pterional approach is an indicated neurosurgical approach commonly used for anterior circular aneurysms, suprasellar lesions, and medial sphenoid wing tumors (1,2). A curvilinear incision from the midline widows peak and extending laterally to 1 cm anterior to the tragus of the ear, terminating within a skin crease, with preservation of the superficial temporal artery if possible. The temporalis fascia is encountered and divided. Either the entire temporalis muscle can be elevated or a cuff of temporalis muscle can be left on the cranium to facilitate closure and suspend the temporalis muscle. Subperiosteal dissection of the muscle is performed and the craniotomies are then accomplished.

Reconstruction of the pterional approach can be accomplished with bony fixation of the bone flap. However, the TMS can be performed by:

1. Resuspension of the temporalis muscle to the cuff of muscle left on the temporal crest or
2. Suturing the temporalis muscle directly to one of the bone plates that is used to for fixation.

The purpose of this prospective study is see if traditional techniques to the closure and temporal muscle suspension (TMS) after the pterional approach will show any differences in post-operative temporal hollowing (TH).

Eligibility Criteria:
Inclusion Criteria:

* This study will include all patients over the age of 18 years who qualify for a pterional approach for their neurosurgical pathology.

Exclusion Criteria:

* Excluded patients will be protected populations, such as inmates or children. Patients will not be excluded on the basis of pregnancy.
Recurrent Nerve Monitoring During Aortic Arch Repair

Almost half of newborns undergoing surgery to repair narrowing or interruption of the aortic arch will suffer injury to the recurrent laryngeal nerve. This causes a weak voice and can lead to problems with feeding including aspiration of milk feed after the surgery. As these children can have a vulnerable circulation, aspiration events can reduce survival and poor weight gain has been shown to correlate with poorer outcomes after surgery.

In other types of surgery in the neck, monitors can be used to alert the surgeon to when injury is occurring to the recurrent nerve. To date, this type of monitoring has not been possible in newborns. This study aims to investigate if this type of monitoring is feasible in newborns undergoing aortic arch repair, to prevent recurrent nerve injury.


Eligibility Criteria:
Inclusion Criteria:

* Only patients with parents/ carers able to give informed consent to participation in the trial will be included. • Male and female patients will be included
* Only Neonates (babies less than 28 days of age) will be included in the study.
* Only patients undergoing repair of the aortic arch via median sternotomy will be included in the study

Exclusion Criteria:

* Patients with severe abnormalities of the airway, such that they are unlikely to be extubated within 7 days of the aortic arch repair surgery will be excluded from participation, as assessment of vocal cord function will be difficult/ impossible in such patients.
* Patients with parents/ carers who are unable to give informed consent to participation in the trial will be excluded from participation.
ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease

This study is designed to evaluate safety and efficacy of fosgonimeton (ATH-1017) in the treatment of mild to moderate Alzheimer's disease with a randomized treatment duration of 26-weeks.

The study is designed to evaluate safety and efficacy of ATH-1017 in mild to moderate AD subjects, with randomized, parallel-arm treatment duration of 26 weeks, and based on clinical diagnostic criteria of Alzheimer's disease. Clinical efficacy is demonstrated by improvement in cognition and global/functional assessments comparing treatment to placebo.

Eligibility Criteria:
Key Inclusion Criteria:

* Age 55 to 85 years
* Mild-to-moderate AD dementia subjects, MMSE 14-24, CDR 1 or 2 at Screening
* Clinical diagnosis of dementia, due probably to AD, by Revised National Institute on Aging-Alzheimer's Association criteria (McKhann, 2011)
* Body mass index (BMI) of ≥ 18 and ≤ 35 kg/m2 at Screening
* Reliable and capable support person/caregiver
* Treatment-free (subjects not receiving acetylcholinesterase inhibitor \[AChEI\] treatment), defined as:

  * Treatment-naïve, OR
  * Subjects who received an AChEI in the past and discontinued at least 4 weeks prior to Screening

Key Exclusion Criteria:

* History of significant neurologic disease, other than AD, that may affect cognition, or concurrent with the onset of dementia
* Subject has atypical variant presentation of AD, if known from medical history, particularly non-amnestic AD
* History of brain MRI scan indicative of any other significant abnormality
* Diagnosis of severe major depressive disorder even without psychotic features.
* Significant suicide risk
* History within 2 years of Screening, or current diagnosis of psychosis
* Myocardial infarction or unstable angina within the last 6 months
* Clinically significant cardiac arrhythmia (including atrial fibrillation), cardiomyopathy, or cardiac conduction defect (note: pacemaker is acceptable)
* Subject has either hypertension or symptomatic hypotension
* Clinically significant ECG abnormality at Screening
* Chronic kidney disease with estimated glomerular filtration rate (eGFR) \<45 mL/min
* Hepatic impairment with alanine aminotransferase or aspartate aminotransferase \> 2 times the upper limit of normal, or Child-Pugh class B and C
* Malignant tumor within 3 years before Screening
* Memantine in any form, combination or dosage within 4 weeks prior to Screening
* Acetylcholinesterase inhibitors in any dosage form
* The subject has received active amyloid or tau immunization (i.e., vaccination for Alzheimer's disease) at any time, or passive immunization (i.e., monoclonal antibodies for Alzheimer's disease) within 6 months of Screening
Impact of Disease on the Concept of End-of-life Decisions of the Elderly in the Community

The purpose of this study is to determine the priorities of the elderly in the community about end-of-life decisions. To check the perception of the disease in the elderly in the community.

This study is descriptive adapters which examines the relationship between illness perception and preferences of end of life decisions in the elderly in the community.

Population and sample: The target population will be elderly and healthy community elderly population was accessible due to a special branch of the club together in the center of the country. Sample to be a sample of convenience. The study will include 88 seniors aged 65 and over to get the power of 0.80 and alfa 0.05, Tools: The study used three tools.

* The first tool is a questionnaire on demographic and clinical details
* The second tool questionnaire the Long term support program (LTSP)
* The third tool is a questionnaire perception of the disease Revised Illness Perceptions Questionnaire (IPQR)

The research process:

Investigator will present the proposal to the Commissioner Fund hospitals and request approval for the study. After receiving approval from the director Department of Health fund the hospital will make data collection phase HMO, days and hours of reception. Interrogator he is to partition the questionnaires and will be present when filling out the questionnaires to help, if and created a situation of lack of understanding of the questionnaires. Scholar, came to the population for the Disabled arriving at the clinic visit, and introduce himself and the subject of research. investigator will indicate questionnaire is anonymous.

Eligibility Criteria:
Inclusion Criteria:

* Chronic illness
* Literate in Hebrew
* Treated in community HMO

Exclusion Criteria:

* Someone hospitalized in previous year
* History of mental illness
* Cognitive problems
Robotic Versus Laparoscopic Roux En-y Gastric Bypass

This study retrospectively identified 33 consecutive obese patients who underwent either laparoscopic or robotic gastric bypass procedures over a 2-year period.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) ≥35-39 kg/m2 with one obesity- associated co-morbidity
* BMI≥40kg/m2, age ≥ 18 years.

Exclusion Criteria:

* Re-do surgery procedures
Compatibility of Qnox Values With Hemodynamic Changes in Tracheal Intubation Procedures

The study aimed to analyze the compatibility of Qnox values with hemodynamic changes as a predictor of pain response in tracheal intubation procedures

Fifty-four patients were given informed consent before enrolling the study. Non-invasive blood pressure monitor, electrocardiogram, pulse oxymetry, and Conox probe were set on the subjects in the operation room. Baseline hemodynamic is noted. General anesthesia induction was done by fentanyl 2.5 mcg/kg and propofol 2 mg/kg. Endotracheal tube intubation was facilitated with rocuronium 0.8 mg/kg as muscle relaxant. qNox values right before intubation and after intubation is noted, as well as hemodynamic changes in one minute after intubation

Eligibility Criteria:
Inclusion Criteria:

* patient undergoes general anesthesia with tracheal intubation
* fasting as required for surgery
* physical ASA status I - II
* signing informed consent

Exclusion Criteria:

* patient with difficult airway management
* patient with history of central nervous system abnormalities
* patient with history of hypersensitivity to drugs for general anesthesia
Eradication of Malignant Carcinoma in the Breast Tissue

The purpose of this study is to confirm the findings of an early study and expand our knowledge of treating Malignant Carcinoma in the Breast Tissue Using an ATP (Adenosine-5'-Triphosphate) Inhibitor.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of breast cancer
* Referred to the study by their treating physician

Exclusion Criteria:

* Any type of treatment for breast cancer before starting the study
Vitamin D as a Prognostic Marker on Assisted Reproductive Technologies Outcomes.

Studying the effect of Vitamin D administration on assisted reproductive outcomes in women undergoing Intra Cytoplasmic Sperm Injection (ICSI) by giving a dose of vitamin D and determining the effect of this dose on both the quality embryos, implantation and ongoing pregnancy rate.

1. Ninty women will include in the study. All patients will be treated with gonadotropin releasing hormone (GnRH) agonist "Decapeptyl" 0.1 mg subcutenoussubcutaneous "FeringFerring, Germany" and vitamin D (D- Dep) from day 20 of the preceding cycle till the day of HCG administration for preparation of ICSI.
2. Controlled ovarian hyper stimulation will be done with Gonal F "recombinant FSH", starting from day 3 of the stimulation cycle according to the standard protocol of the center. The dose is calculated according to the ovarian reserve, age as the BMI.
3. HCG and Vitamin D will be given when one or more of the growing follicles reaching 17 mm of diameter or more.
4. Ovum pickup was done guided by the transvaginal ultrasonography 34-36 hours after HCG administration. Follicular fluid and blood sample were obtained at the time of ovum pickup for ICSI/IVF.
5. This prospective randomized case control trial will include 90 women who will be allocated IVF/ICSI. They will be sub divided into a study and a control group; each group will include 45 women.

Eligibility Criteria:
Inclusion Criteria:

1. Age is between 20-40 years old.
2. Non PCOS patient.
3. With no previous or current evidence of OHSS (number of oocyte between 5-15 oocytes)
4. Normal Prolactin level.
5. No other endocrinological abnormality including thyroid disorder or diabetes.
6. Within normal ovarian reserve AMH(1-3) ng/ml No evidence of endometriosis.
7. No other medical or surgical diseases.

10-Careful history, general and local examination, abdominal and vaginal ultrasonography and basal haematological and chemical investigations were done

to exclude any other abnormalities which can interfere with the result of the current study.

Exclusion Criteria:

1. Women older than 35 years of age or younger than 20 years old
2. Women with polycystic ovary syndrome PCOS (as defined according to the Rotterdam criteria)
3. Women who were diagnosed to have endometriosis within the last 1 year.
4. Women with ovarian hyper stimulation syndrome (OHSS).
5. Sever male factor infertility with immotile sperm which may affect embryo development
6. poor responder patient .
An Study to Determine the Bioavailability of E2609 Tablets Compared to Capsules and the Effect of Food on Absorption

This study will be a single-center, open-label, randomized, 3-treatment crossover study of single oral doses of an API-capsule formulation of E2609 under fasted conditions and a tablet formulation administered under fed and fasted conditions in healthy subjects.


Eligibility Criteria:
Inclusion Criteria

1. Caucasian males defined as persons of a European or Latin American descent
2. Healthy male 30 to 55 years inclusive at the time of informed consent
3. Body mass index (BMI) of 18 to 32 kg/m2 at Screening
4. Subjects must have had a successful vasectomy (confirmed azoospermia), or they and their female partners must not be of childbearing potential or must be practicing highly effective contraception throughout the study period and for 30 days after study drug discontinuation. No sperm donation is allowed during the study period and for 30 days after study drug discontinuation.

Exclusion Criteria

1. Any history of seizures or epilepsy (not including a history of simple febrile seizures in childhood) or disturbance of consciousness likely to be due to seizures
2. Any medical condition which, in the opinion of the investigator has high risk of seizures (e.g., history of traumatic brain injury associated with loss of consciousness or amnesia, alcohol abuse, substance abuse) at Screening or within past 5 years
3. Any history of cerebrovascular disease (stroke or transient ischemic attack)
4. A history of prolonged QT/QTc interval or prolonged period from the beginning of the QRS complex to the end of the T wave on an ECG (QT)/ QT corrected for heart rate using Fridericia?s formula (QTcF) interval (QTcF \&gt; 450 ms) as demonstrated by the mean of triplicate electrocardiogram (ECGs) (recorded at least 1 min apart) at Screening or Baseline Period
5. Any other clinically significant ECG abnormalities at Screening or Baseline Periods, e.g. component of the ECG cycle from onset of atrial depolarization to onset of ventricular depolarization (PR)\&gt;220 ms, component of ECG wave representing ventricular depolarization (QRS)\&gt;110 ms
6. Hypersensitivity to the study drugs or any of their excipients
REFRaME-O1: A Study to Investigate the Efficacy and Safety of Luveltamab Tazevibulin Versus Investigator's Choice (IC) Chemotherapy in Women With Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing FOLR1

A Phase 2/3 study to investigate the efficacy and safety of luveltamab tazevibulin versus IC chemotherapy in women with ovarian cancer (including fallopian tube or primary peritoneal cancers) expressing FOLR1.

This is a randomized, multicenter, international, open-label, 2-part, Phase 2/3 study designed to assess the efficacy and safety of luveltamab tazevibulin versus IC chemotherapy in subjects with relapsed platinum-resistant epithelial ovarian cancer expressing FOLR1.

Part 1 will consist of 2 luveltamab tazevibulin dosing cohorts (Cohort A and Cohort B), with subjects randomized 1:1. Part 1 will be used to select the optimized dosing regimen.

Part 2 will further evaluate the efficacy and safety of the selected dosing regimen versus IC chemotherapy.

Luveltamab tazevibulin will be administered intravenously (IV) over a 1-hour infusion time every 3 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. High grade serous epithelial ovarian cancer, fallopian tube or primary peritoneal cancer
2. Age ≥ 18 years
3. ECOG performance status 0 to 1
4. Positive FOLR1 expression per central laboratory testing
5. Relapsed platinum-resistant epithelial ovarian cancer and received a total of 1 to 3 prior regimens
6. Prior bevacizumab treatment is required, if labeled and available as standard of care per institutional guidelines, unless subject has documented contraindication
7. At least 1 measurable target lesion per RECIST v1.1
8. Adequate organ function

Exclusion Criteria:

1. Low grade (Grade 1) ovarian carcinoma, clear cell, mucinous, endometrioid, sarcomatous, and mixed histology ovarian carcinomas
2. Prior treatment with a FOLR1- targeting ADCs or with ADCs that contain a tubulin inhibitor
3. Primary platinum-refractory disease
4. History of severe allergic or anaphylactic reactions to monoclonal antibody therapy or to antibody-related fusion protein treatment
5. Pre-existing clinically significant ocular disorders, severe chronic obstructive pulmonary disease or asthma, clinically significant cardiac or cerebrovascular disease, or other significant concurrent, uncontrolled medical condition
6. Previous solid organ transplantation
7. History or clinical signs of meningeal or active central nervous system involvement
8. Concurrent participation in another therapeutic treatment trial