cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ALXN1007 in Healthy Male and Female Subjects

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple intravenous (IV) doses of ALXN1007 in healthy male and female subjects.


Eligibility Criteria:
Inclusion Criteria:

Healthy male or female (not of childbearing potential) subjects ≥25 and ≤55 years old.

2. QTcF ≤450 msec and ≤470 for females. 3. Willing and able to give written informed consent and comply with the study visit schedule.

4. Male subject and his female spouse/partner who is of childbearing potential must be using highly effective congraception1 consisting of two forms of birth control (at least one of which must be a barrier method) starting at Screening and continuing until the end of study.

1. Highly effective contraception is defined as:

   * Established use of oral, injected or implanted hormonal methods of contraception.
   * Placement of an intrauterine device or intrauterine system.
   * Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.

     5. Male subjects must not donate sperm starting at Screening until the end of study.

     6. Documented vaccination with meningococcal conjugate vaccine (MCV4) at least 14 days and not more than 5 years, prior to dosing.

Exclusion Criteria:

Female subjects of childbearing potential, including any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal. Postmenopausal is defined as:

* Amenorrhea ≥ 12 consecutive months without another cause and a documented serum follicle stimulating hormone (FSH) level \>35 mIU/mL or
* Female subjects with irregular menstrual periods and a documented serum FSH level \> 35 mIU/mL.
* Women on hormone replacement therapy (HRT). Women who are using oral contraceptives, other hormonal contraceptives (i.e., vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (i.e., diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential.

  2. Positive serum pregnancy test at Screening or Day -1. 3. Serum creatinine great than the upper limit of normal (ULN) of the testing laboratory at Screening and Day -1.

  4. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>ULN of the testing laboratory at Screening and Day -1.
Dietary Intake After Laparoscopic Sleeve Gastrectomy -a 5 Year Study

Weight reducing surgery is the only effective therapy for morbid obese patients.

Sleeve gastrectomy is a popular choice for bariatric surgery because of less sequela. There is poor knowledge about the nutritional status inpatients after LSG. The aim of our study was to investigate the relationship between dietary intake and weight loss after LSG.

Weight reducing surgery is the only effective therapy for morbid obese patients. Restrictive type surgery is safer than mal-absorptive type surgery. Laparoscopic sleeve gastrectomy is an effective surgery. In laparoscopic sleeve gastrectomy (LSG), about 90% of the stomach is surgically removed by vertical resection of the great curvature side, including the fundus. The simplicity of surgical procedures, the low occurrence of complications, and the efficiency of reducing excess weight have made LSG as a popular choice for bariatric surgery. After LSG, the amount of food eaten is drastically reduced, leading to nutritional deficiencies potentially. There is poor knowledge about the nutritional status inpatients after LSG. Some literatures suggest that LSG results in less nutritional deficiencies than Roux-en-Y gastric bypass. The aim of our study was to investigate the relationship between dietary intake and weight loss after LSG.

Eligibility Criteria:
Inclusion Criteria:

* morbid obesity patients received laparoscopic sleeve gastrectomy for more then 5 years.

BMI above 40 kg/m2 when operation. Age 18-65 years old. No major psychosis or binge eating disorder. No endocrine disease. failed to lose weight with medical therapy.

Exclusion Criteria:

* current hepatitis, under steroid treatment,cancer, thyroid disease,alcoholism.
Automated Fetal Heart Echocardiography by Five-Dimensional Ultrasound in the Third Trimester of Pregnancy

The aim of the study to evaluate Five-Dimensional Ultrasound in automated assessment of the fetal heart from 20-36 weeks of gestation.

This is a Prospective pilot study that will be performed at the Fetal Care Unit at Ain Shams University Maternity Hospital.

90 pregnant women will be recruited from the Fetal Care Unit who will fulfill the inclusion criteria. They will be counseled to be included into the study.

All cases will be subjected to:

1. Full history taking including patient's age, parity, last menstrual period, estimated gestational age by dates, past history of medical disorders, clinical examinations (General and abdominal).
2. Two-Dimensional Ultrasound and Five-Dimensional Ultrasound will be done for all cases for assessment of fetal Heart.

   * 90 consecutive patients will undergo 2D fetal echocardiography by one observer
   * Then they will undergo blindly Five-Dimensional fetal echocardiography by another observer
   * The data collected will be compared to evaluate the accuracy of Five-Dimensional US in fetal heart assessment.

Eligibility Criteria:
Inclusion Criteria:

1. Singleton pregnancy.
2. Gestational age at 34-36 weeks as determined be date and last menstrual period.
3. Normal Amniotic Fluid Index.

Exclusion Criteria:

1. Multiple pregnancies.
2. Oligohydramnios or Polyhydramnios (AFI \> 95th percentile or \< 5th percentile).
3. Obese patient, BMI \> 30
4. Intrauterine growth restriction.
5. Fetal spine between the 11- and 1- O'clock positions due to possibility of shadowing from ribs or spine
Retinal Blood Flow in Response to an Intravitreal Injection of Ranibizumab for Central Retinal Vein Occlusion (CRVO)

Ranibizumab (Lucentis, Genentech) is an off-label drug used for the clinical treatment of central retinal vein occlusion, which is one of the most common retinal vascular disorders. Despite its clinical effectiveness, concerns remain regarding the systemic effects of the drug and previous studies have noted retinal arteriolar vasoconstriction following a ranibizumab injection. We aim to provide a physiological basis to these observations by assessing retinal blood flow before and after the ranibizumab injections. Specifically, we will assess the blood flow parameters (i.e. retinal vessel diameter, velocity \& flow) immediately before the first injection and post-injection over a follow-up continued treatment period.

Ranibizumab is an antibody fragment designed to inhibit the activity of Vascular Endothelial Growth Factor (VEGF), which is responsible for the neovascularization and retinal edema responsible for interference of normal vision in central retinal vein occlusion. However, VEGF has a role in the vasculature as a vasodilator where it alters the expression of tight junction proteins and upregulates the release of the vasodilator nitric oxide. Consequently, intravitreal ranibizumab injections could result in systemic inhibition of VEGF, leading to long-term retinal arteriolar vasoconstriction and potentially adverse cerebrovascular and myocardial accidents. Therefore, evaluating retinal blood flow would provide a physiological foundation to this concern and provide physicians with valuable information regarding the risks of continued ranibizumab therapy.

Given the role of VEGF as a vasodilator in the vasculature where it works to alter the expression of tight junction proteins and the production of vasoactive substances especially nitric oxide, inhibiting this molecule with ranibizumab could result in vasoconstriction in these vessels. We hypothesize that vasoconstriction and decreased retinal blood flow will be observed after an intravitreal injection of ranibizumab for treatment of central retinal vein occlusion.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 50 years
* central retinal vein occlusion scheduled for first intravitreal injection of ranibizumab as part of their clinical care

Exclusion Criteria:

* previous history of intravitreal therapy,
* history of thromboembolic events,
* glaucoma or an intraocular pressure \>21 mmHg
* diabetes mellitus or altered blood viscosity syndromes
* blood donation in the previous 2 weeks
* refractive error of +/- 6.00 DS and/or 2.00 DC
Combination Chemotherapy With or Without Amifostine in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma or Hodgkin's Disease Undergoing Stem Cell Transplantation

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy.

PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy with or without amifostine in treating patients with recurrent or refractory non-Hodgkin's lymphoma or Hodgkin's disease who are undergoing autologous stem cell transplantation.

OBJECTIVES: I. Evaluate the role of amifostine in reducing hematologic toxicity and improving mobilization of peripheral progenitor stem cells in patients with recurrent or refractory non-Hodgkin's lymphoma or Hodgkin's disease who are undergoing platinum based salvage chemotherapy. II. Evaluate the role of amifostine in preventing renal toxicity in these patients.

OUTLINE: This is an randomized, open label study. Patients are randomized to receive salvage chemotherapy with intravenous dexamethasone/cisplatin/cytarabine (DHAP) with or without amifostine. Patients receive cisplatin IV over 3 hours followed by cytarabine IV for 2 doses. Patients also receive dexamethasone orally or IV. Treatment repeats every 3-4 weeks for 2-6 courses. Arm I: Patients receive amifostine IV over 15 minutes prior to all courses of DHAP, as a 15 minute infusion, beginning 30 minutes prior to cisplatin administration. Arm II: Patients do not receive amifostine. On day 3 of the last DHAP course, patients receive filgrastim (G-CSF) until the last day of progenitor stem cell (PSC) mobilization. PSC transplant continues daily for 4-10 days.

PROJECTED ACCRUAL: A total of 40 patients (20 per treatment arm) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven recurrent or refractory non-Hodgkin's lymphoma or Hodgkin's disease requiring salvage chemotherapy Prior treatment with at least 3 courses of first line chemotherapy

PATIENT CHARACTERISTICS: Age: Over 18 Performance Status: ECOG 0-2 Life Expectancy: Greater than 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 50,000/mm3 Hepatic: Not specified Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 40 mL/min Cardiovascular: No symptomatic congestive heart failure (class III or more as defined by American Heart Association) Electrolytes: Potassium at least 3.4 meq/L Magnesium at least 1.4 meq/L Other: Not pregnant or nursing

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior high dose chemotherapy with stem cell transplant At least 3 courses of first line chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Diagnostic Importance of the Circulating Human Leucine-rich α-2-glycoprotein in Acute Appendicitis in Pediatric Patients

Acute appendicitis is a common and potentially serious medical condition which can be difficult to diagnose, especially in pediatric patients. To help recognize patients with acute appendicitis, number of laboratory and radiological test are used. Previous research has shown that Circulating Human Leucine-rich α-2-glycoprotein (LGR1) in the blood can be elevated in pediatric patients with acute appendicitis. The aim of this research is to analyse whether LGR1 levels in saliva can be used as a less invasive diagnostic method in pediatric patients with suspected acute appendicitis.


Eligibility Criteria:
Inclusion Criteria:

* children with age from 5 do 17 with acute abdominal pain
* children with clinical signs of appendicitis

Exclusion Criteria:

* previous diagnosis of chronic and/or malignant disease
* children which had previous abdominal surgery
* pregnancy
Telehealth Group-based Emotional Awareness and Expression Therapy for Patients With Persistent Physical Symptoms: A Pilot Study

Delivering Emotional Awareness and Expression Therapy (EAET) through digital or telehealth platforms in a group format offers several key advantages. First, it significantly improves access to care, allowing individuals with persistent physical symptoms (PPS) to receive effective, emotion-focused therapy regardless of their geographic location. Telehealth can also benefit those who face mobility issues or have limited access to specialized care in rural or underserved areas.

Group-based telehealth EAET promotes social connection among participants, fostering a supportive environment where individuals can share experiences, which may enhance therapeutic outcomes. Additionally, the convenience of remote therapy can reduce barriers to participation, such as time constraints and travel costs, making it easier for patients to commit to treatment.

Finally, the digital format allows for flexible, scalable interventions that can be easily integrated into routine psychiatric care, potentially increasing treatment uptake for individuals who might otherwise avoid in-person therapy due to stigma or logistical challenges.


Eligibility Criteria:
Inclusion Criteria:

* The participant certifies that he or she has undergone a medical evaluation for their physical symptoms (see separate certificate).
* The participant rates either moderate distress from physical symptoms on the PHQ-15 form (over 10 points) or significant distress from a single physical symptom (at least 2 points for that symptom).
* The participant expresses interest in exploring whether emotional factors, such as stress, may contribute to their symptom profile.
* Any prescribed medications must have been stable for at least 1 month.

Exclusion Criteria:

* Participants suffer from ongoing substance abuse (alcohol or drugs) or are assessed to have severe mental health issues (psychotic disorders, moderate to high suicide risk, antisocial personality disorder, etc.).
* Participants are currently prescribed medications that are clearly addictive and sedative in nature (e.g., benzodiazepines).
* Participants are involved in other psychological treatments focused on physical symptoms. However, other psychological treatments are allowed as long as the supportive therapy does not occur more than once a month.
* Participants do not have sufficient proficiency in the Swedish language.
Postmarketing Surveillance Study for Use of Menactra® in the Republic of Korea

The purpose of the study is to perform the re-examination of Menactra® administered in the routine clinical settings in accordance with the Ministry of Food and Drug Safety regulation.

Primary objective:

* To describe the safety profile after 1 dose of Menactra® administered from 9 months to 55 years of age under standard health care practice.

Subjects aged 9 months through 55 years and who are given study vaccine during routine health-care visits will be enrolled in the study.

They will be followed-up for up to Day 42 following vaccination.

No study vaccine will be supplied or administered as part of this study, subjects will be monitored following routine vaccine administration in clinical settings.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent form signed by the subject (for subjects from 19 to 55 years of age) or the parent(s) or other legal representative (for subjects from 9 months to 18 years of age)
* Receipt of one dose of Menactra® (on the day of inclusion) according to approved local product insert paper .

Exclusion Criteria:

* Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or a medical procedure
* Subjects who already participated in this study.
Nonverbal Synchrony, Therapeutic Alliance and Treatment Engagement in First Episode Schizophrenia

The quality of the therapeutic intervention in a first psychotic episode is a major challenge for quality and effectiveness of treatment. This project aims to better understand the mechanisms underlying the quality of communication between patient and psychiatrist, especially those related to non-verbal communication. Psychiatrist/patient interpersonal motor synchronization is a reliable index of therapeutic alliance and a predictor of psychotherapy effectiveness. This project aims to show a link between psychiatrist and patient motor synchrony and treatment adherence. This link could be explained by an association between therapeutic alliance and motor synchronization.

Several studies have highlighted the utmost importance of initial medical and psychosocial support during a first psychotic episode. Recent research has shown that non-verbal communication and particularly interpersonal motor synchronization between the patient and his psychiatrist is a key factor in therapeutic alliance. However, such hypothesis have never been tested in terms of treatment adherence neither in a first psychotic episode, nor during a 6-month follow-up. By measuring the interpersonal motor synchronization between the patient and psychiatrist during a video recorded interview at inclusion, month-3 and month-6, the project aims to validate the hypothesis that a high level of interpersonal synchronization should be associated with a high level of therapeutic alliance. This therapeutic alliance being hypothesized as a mediator between synchronization and treatment adherence, the project should show for the first time in a first psychotic episode that the use of reliable and objective variables extracted from the analysis of the synchronization between psychiatrist and patient allows to predict the outcome of therapeutic and treatment alliance.

Eligibility Criteria:
Inclusion Criteria:

* Patients after hospitalisation for a first psychotic episode (OMS criteria 1992)
* Patients fluent in French (spoken and written)
* Age ≥ 18 years and \< 50 years
* signed informed consent
* participation noted in medical files.

Exclusion Criteria:

* Inpatients
* History of brain trauma
* History of neurological disease
* Current Electro-convulsive-treatment
* Drug abuse and dependence (except for tabacco and cannabis)
* Pregnant/breast feeding woman
A VI-0521 Study to Evaluate the Long-term Safety and Efficacy in Type 2 Diabetic Adults

The purpose of the study is to determine the long-term safety and efficacy of VI-0521 (phentermine/topiramate) compared to placebo in providing blood sugar control in Type 2 diabetic adults. Continuation of initial 6 month trial.


Eligibility Criteria:
Inclusion Criteria:

* Have completed the qualifying OB-202 trial
* If females of child-bearing potential, subjects must be using adequate contraception
* Provide written informed consent
* Be willing and able to comply with scheduled study visits, treatment plan, lab tests and other study procedures

Exclusion Criteria:

* Subjects who have developed one or more morbidities during the OB-202 trial that would pose a safety concern
Ablation Targets of Scar-related Ventricular Tachycardia Identified by Dynamic Functional Substrate Mapping

This study aims at comparing the recurrence rates of ventricular tachycardia ablated after being mapped by 2 different techniques.

The study participants are patients presented with recurrent ventricular tachycardia.

They will be divided into 2 groups in terms of mapping. The first group will use mapping during sinus rhythm to identify late potentials that may be incriminated in the tachycardia circuit.

The other group will undergo mapping during right ventricular extrastimulus pacing to unmask hidden potentials. The identified potentials will be ablated in both groups.

Eligibility Criteria:
Inclusion Criteria:

* • Patients with structural heart disease; previous myocardial infarction, left ventricular dilatation/systolic dysfunction, or normal left ventricular diameters/ systolic function with evidence of ventricular scar on contrast enhanced-cardiac magnetic resonance or electroanatomic map.

  * Sustained monomorphic ventricular tachycardia documented by 12-lead ECG or implantable cardioverter defibrillator (electrograms resistant to antiarrhythmic drug treatment or requiring implantable cardioverter defibrillator therapies.

Exclusion Criteria:

* • Patients with ventricular arrhythmias attributed to reversible causes.
Motor Control During Rapid Eye Movement (REM) Sleep Behaviour Disorder

To compare the electrical activity of SubThalamic Nuclei (STN), by mean of local field potentials recordings, during the phasic behaviours of RBD with the electrical activity recorded at this level during the execution of voluntary movements during the "off" and the "on" phases in patients with RBD secondary to PD.

Patient with severe Parkinson's disease (PD) with motor fluctuations are akinetic and bradykinetic during the "off" phases. Their motor status dramatically improves during "on" phases, due to the effect of dopaminergic agents.

In the off phases, the plasmatic levels of dopaminergic drugs are the lowest. The plasmatic levels of dopaminergic drugs are also very low during nocturnal sleep.

Nevertheless, PD patients may show vigorous and rapid movements during REM Behaviour Disorder (RBD). Thirty-three to 46% of the patients with PD have RBD.

Akinesia and bradykinesia are the consequence of a hyperactivity of the SubThalamic Nuclei (STN). The electrophysiological correlate of this hyperactivity causing akinesia and bradykinesia is represented by STN beta activity, recorded by local field potentials.

STN beta activity is not present during the execution of a voluntary movement at an "on" phase. Levodopa therapy, which can revert akinesia and bradykinesia, also suppress STN beta activity in PD patients The STN is the surgical target for Deep Brain Stimulation (DBS) of the basal ganglia to improve the motor symptoms of PD.

The STN has bilateral connections with the laterodorsal nucleus/pedunculopontine tegmentum (LDT/PPN), a key structure for REM sleep regulation.

The investigators hypothesize that during the execution of the phasic motor behaviours of RBD the pattern of discharge of STN differs from the one observed during voluntary movements in the "off" phase, in PD patients. In other terms, we expect the STN beta activity to disappear during the execution of phasic motor behaviors of RBD.

Eligibility Criteria:
Inclusion Criteria:

* Men and women, 35 to 70 years old, with idiopathic PD (UKPDSBB criteria) with motor fluctuations
* having RBD according to the International Classification of Sleep Disorders, 2nd edition (ICSD-2) criteria
* Eligible to neurosurgical treatment of PD by implantation of intracranial electrodes for the DBS of STN
* Giving a written informed consent
* Affiliated to the French social security program

Exclusion Criteria:

* Atypical or secondary parkinsonian syndrome
* Cognitive impairment which may compromise the understanding and patient's participation to the protocol (Mattis dementia rating scale score ≥ 136)
* Patient under guardianship, trusteeship or judicial protection
* Pregnancy or breastfeeding
* Patient participating to another clinical research study in the same period