cyrilzakka/clinical-trials huggingface dataset:
Transcranial Magnetic Stimulation (TMS) for Treatment of Auditory Hallucinations

Transcranial magnetic stimulation (TMS) involves the use of magnetic fields to non-invasively stimulate the brain. Studies overseas have suggested this may be an effective and safe treatment for auditory hallucinations in patients with schizophrenia. This is a sham-controlled, double-blind trial of TMS stimulation for the treatment of auditory hallucinations in patients with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Over 18, with DSM-IV diagnosis of Schizophrenia and auditory hallucinations of clear external origins, refractory to pharmacotherapy and occurring at least 5 times per day.

Exclusion Criteria:

* Subjects with contraindications to TMS (e.g. epilepsy, pacemaker) or those with an unacceptably high risk (e.g. suicide risk) will be excluded from the study.
Dose-response Study of Efficacy and Safety of Botulinum Toxin Type A to Treat Spasticity of the Leg(s) in Cerebral Palsy

The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg(s) are effective in treating children/adolescents (age 2-17 years) with increased muscle tension/uncontrollable muscle stiffness (spasticity) due to cerebral palsy.


Eligibility Criteria:
Inclusion Criteria:

* Female or male subject of 2 to 17 years of age (inclusive).
* Uni- or bilateral cerebral palsy with clinical need for uni- or bilateral LL injections with BoNT for the treatment of spasticity.
* Ashworth Scale \[AS\] score ≥2 in plantar flexors (at least unilaterally).
* Clinical need for a total dose of 16 U/kg BW NT 201 (maximum of 400 U) for the treatment of LL spasticity according to the clinical judgment of the investigator.

Exclusion Criteria:

* Fixed contracture defined as severe restriction of the range of joint movement on passive stretch or predominant forms of muscle hypertonia other than spasticity (e.g., dystonia) in the target limb(s).
* Surgery on pes equinus on side(s) intended to be treated with BoNT injections in this study within 12 months prior to Screening Visit (V1), in the screening period or planned for the time of participation in this study.
* Hip flexion requiring BoNT injection.
Impact of Virtual Reality Model for Pelvic Floor Anatomy on Users' Educational Level and Experience

The purpose of the study is to evaluate the impact of virtual reality (VR) model for pelvic floor anatomy on users' educational level and experience.

Virtual reality (VR) has gained significant attention as an educational tool in various fields, including science and health education. Its capacity to create immersive, interactive environments allows students to explore complex, three-dimensional structures, enhancing visualization and understanding of abstract or intricate concepts. VR can bridge gaps in traditional education by offering experiences that are otherwise challenging to replicate in conventional classroom settings, such as real-time manipulation of anatomical models.

In health sciences, VR is particularly valuable for anatomy education. Studies have shown that VR's interactive and immersive nature fosters deeper comprehension, especially in understanding spatial relationships within anatomical structures. A VR model for pelvic floor anatomy could therefore serve as a powerful tool, allowing users to engage in a hands-on learning experience that enhances knowledge retention and user satisfaction.

Research indicates that VR may improve educational outcomes not only through knowledge acquisition but also by stimulating students' motivation and positive attitudes toward learning. A recent study has found that VR helped students develop problem-solving and visualization skills, which are crucial for disciplines requiring spatial awareness, such as anatomy. However, while VR shows promise, questions remain about its effectiveness compared to traditional educational methods, especially in specialized fields like pelvic floor anatomy.

Eligibility Criteria:
Inclusion Criteria:

* Physical therapy undergraduate, graduate, and postgraduate students, as well as professionals.
* Participants must be physically able to wear and interact with a VR headset

Exclusion Criteria:

* Lack of Anatomy Background.
* Prior Extensive VR Experience in Anatomy.
* Severe Motion Sickness or Visual Disorders.
Resveratrol: A Potential Anti- Remodeling Agent in Heart Failure, From Bench to Bedside

The purpose of this study is to determine if resveratrol can improve heart function and quality of life. Although, population studies have revealed that a mild to moderate intake of red wine reduces cardiovascular disease risk in humans, clinical studies that evaluate the potential heart benefits of resveratrol in patients with non-ischemic cardiomyopathy have not been previously reported. Accordingly, this research is being done because it will fill this deficiency in the information available in the literature and establish the clinical benefits of resveratrol in patients with this type of heart disease.

The investigators will conduct a randomized double blinded placebo controlled study of 40 adults (≥18 to 90 years old). Twenty (20) subjects will be included in the placebo arm, and 20 in the treatment arm. Patients will be randomly allocated to receive placebo or resveratrol. After randomization, the two groups of subjects will be followed up in exactly the same way, and the only differences between the care they receive will be those intrinsic to the treatment being compared. The randomization will minimize allocation bias, balancing both known and unknown prognostic factors, in the assignment of treatments.

Eligibility Criteria:
Inclusion Criteria:

* Subjects (between 18-90 years of age) with cardiomyopathy, Heart Failure with reduced ejection fraction (HFrEF defined as Left Ventricular Ejection Fraction (LVEF) ≤40%, based on most recent assessment)
* New York Heart Association (NYHA) Functional class II-III (mild-moderate heart failure symptoms)
* On optimal medical management for 6 months as per standard care

Exclusion Criteria:

* Severe valvular cardiomyopathy
* No surgical intervention planned or in past 6 months
* Subjects on \\diltiazem (or any other calcium channel blocker)
* Patients with a history of serious hypoglycemia requiring hospitalization or hyperglycemic emergencies requiring hospitalization in the past 6 months
* Subjects on anticoagulants, Coumadin, dabigatran
* Subjects on HIV protease inhibitor (saquinivir), immunosupressants (cyclosporine, tacrolimus)
* Subjects on terfenadine, midazolam, and triazolam
* Subjects on sildenafil or any other drugs used to treat erectile dysfunction
* • Chronic renal failure (defined as estimated glomerular filtration rate (eGFR) ≤30 mL/min per 1.73m2)
* Known liver cirrhosis
* • Other significant comorbidity e.g. cancer affecting ability to complete study
* Pregnant or lactating women
* Subjects on hormone replacement therapy
* Subjects on estrogen containing birth control
Efficacy and Safety of B I1356 (Linagliptin) vs. Placebo Added to Metformin Background Therapy in Patients With Type 2 Diabetes

The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control


Eligibility Criteria:
Inclusion criteria:

1. Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone, or with metformin and not more than one other oral antidiabetic drug
2. Diagnosis of type 2 diabetes prior to informed consent
3. Glycosylated haemoglobin A1 (HbA1c)at screening:

   For patients undergoing wash out of previous medication: HbA1c 6.5 - 9.0% For patients not undergoing wash-out of previous medication: HbA1c 7.0 - 10.0%
4. Glycosylated haemoglobin A1 (HbA1c) 7.0 - 10.0% at the beginning of Placebo Run-in
5. Age 18 -80 years
6. BMI (Body Mass Index) less than 40 kg/m2
7. Signed and dated written informed consent by date of Visit 1a in accordance with GCP and local legislation

Exclusion criteria:

1. Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent
2. Impaired hepatic function
3. Known hypersensitivity or allergy to the investigational product or its excipients or metformin or placebo
4. Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent
5. Treatment with an injectable GLP-1 analogue (e.g. exenatide) within 3 months prior to informed consent
6. Treatment with insulin within 3 months prior to informed consent
7. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) within 3 months prior to informed consent
8. Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation or drug abuse
9. Participation in another trial with an investigational drug within 2 months prior to informed consent
10. Pre-menopausal women who:

    * are nursing or pregnant,
    * or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial.
11. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.
12. Renal failure or renal impairment
13. Unstable or acute congestive heart failure
14. Acute or chronic metabolic acidosis (present in patient history)
15. Hereditary galactose intolerance
Visualization Engineering Platform for Pulse Diagnosis of Traditional Chinese Medicine-The Research of Similar Moiré Feature Analyzing Approach Based on Recurrent Neural Network to Process the Measured Slip Pulse Wave-Images With Chun, Guan and Chy

The diagnoses processes of Traditional Chinese Medicine (TCM) focus on the following four main types of diagnoses methods consisting of inspection, olfaction, inquiry, and palpation. The most important one is palpation also called pulse diagnosis which is to measure wrist artery pulse by TCM doctor's fingers to detect patient's health state. The pulse diagnosis has three parts, namely 'Chun', 'Guan' and 'Chy', with the location. Wrist measurements correspond to different parts of the body's organs. However, the pulse information is analyzed by TCM doctor's pulse diagnoses process, which is picked only a single waveform from a long-term pulse measured process and often discarded the other waveforms contained in the same information, e.g. Slip Pulse waveform. The research object of this project is to divide the TCM diagnosis patients into two groups, one is the Slip pulse group and the other is a Flat Pulse group, in which the cases are collected at least 50 cases for the first gruop and 30 cases for the second group, individually. The purpose of this project will integrate the TCM doctor's experiences and standardize them in order to construct an effective Slip pulse diagnosis system based on visualization engineering platform. It could refine Slip pulse diagnoses processes and reduce their diagnoses loading by using the proposed approach during this project. Therefore, we will propose a similar Moiré feature analyzing approach based on Recurrent Neural Network to process the measured Slip Pulse wave-images with 'Chun', 'Guan' and 'Chy' in order to prepare this visualization engineering platform. We will measure the waveform images of the three parts of the wrist as 'Chun', 'Guan' and 'Chy' with the moiré feature technology proposed in this project. It mainly extracts the moiré features such as pulse image from numerous measurement 'Chun', 'Guan' and 'Chy' signals, and further analyzes and summarizes them with AI technology. We could extract the pulse characteristics of Slip pulse automatically from the many measurement signals and enhance the automatic judging ability of the current pulse instrument to the Slip pulse waveform. Provide important pulse information to the TCM doctors as an important reference for precision clinical diagnoses.


Eligibility Criteria:
Inclusion Criteria:

1. Already sign test consent permit.
2. More than 20-year-old.

Exclusion Criteria:

1. There is a wound or inflammation at the wrist skin measurement.
Influence of Esmolol on a Closed-Loop Anesthesia System

Main objective is to evaluate the sparing effect of esmolol on the required doses of propofol and remifentanil


Eligibility Criteria:
Inclusion Criteria:

* male patients scheduled for a general anesthesia

Exclusion Criteria:

* age lower than 18 years
* allergy to propofol, or to soja or to peanuts, or to sufentanil, to remifentanil, or to morphine, or to a myorelaxant or to an excipient,
* any other history of anaphylactic reaction,
* hypersensibility to sufentanil, or to remifentanil, or to other derivate of fentanyl,
* hypersensibility to esmolol or to an excipient,
* history of central nervous system disease,
* patients receiving a psychotropic treatment or an agonist-antagonist opiate,
* hypovolemic patients,
* patients receiving a cardio-vascular treatment,
* patients with a pacemaker,
* expected bleeding more than 20% of the blood volume,
* simultaneous general and loco-regional anesthesia,
* patients suffering from asthma, COPD, trouble of the heart rhythm or conduction, cardiac insufficiency, cardiogenogenic shock, Prinzmetal syndrome, pheochromocytoma,
* patients with a heart rate less than 50/min and/or an arterial hypotension,
* neurosurgical act or any other which precludes an adequate positioning of the bispectral electrode.
Use of Low-cost mHealth Intervention to Enhance Outcomes of Noncommunicable Diseases Care in Rural and Refugee Settings

Rural areas and refugee camps are characterized by poor access of patients to needed noncommunicable disease (NCD)-related health services, including diabetes and hypertension. This community trial study aims to assess the effect of employing low-cost mHealth tools on the accessibility to health services and improvement of health indicators of individuals with NCDs in rural areas and refugee camps in Lebanon.

Rural areas and refugee camps are characterized by poor access of patients to needed noncommunicable disease (NCD)-related health services, including diabetes and hypertension. Employing low-cost innovative eHealth interventions, such as mobile health (mHealth), may help improve NCDs prevention and control among disadvantaged populations.

The aim of this study was to assess the effect of employing low-cost mHealth tools on the accessibility to health services and improvement of health indicators of individuals with NCDs in rural areas and refugee camps in Lebanon.

This is a community trial study in which centers were allocated randomly into control and intervention sites. The effect of an employed mHealth intervention is assessed through selected quality indicators examined in both control and intervention groups. Sixteen primary health care centers (eight controls, eight interventions) located in rural areas and Palestinian refugee camps across Lebanon were included in this study. Data on diabetic and hypertensive patients-1433 in the intervention group and 926 in the control group-was extracted from patient files in the pre and postintervention periods. The intervention entailed weekly short message service messages, including medical information, importance of compliance, and reminders of appointments or regular physician follow-up. Internationally established care indicators were utilized in this study.

Eligibility Criteria:
Inclusion Criteria:

* Registered at the Primary Healthcare Center as diabetics and/or hypertensive or diagnosed with or suspected to have diabetes and/or hypertension
* Aged 40 years or more
* Lebanese or Palestinian nationality

Exclusion Criteria:

* aged less than 40 years
* Non-Lebanese / Non-Palestinian
* No exclusion based on gender, educational and literacy level, disability, or presence of other medical conditions
Comparison of Efficacy and Safety of Rimonabant 5mg/Day or 20mg/Day Versus Placebo in Smoking Cessation

The primary objective is to assess the efficacy of 2 fixed doses of rimonabant versus placebo on abstinence from tobacco use in cigarette smokers.

The secondary objective is to evaluate the effects of rimonabant on craving and weight and on the clinical and biological safety and tolerability of rimonabant in a population of cigarette tobacco smokers during a 10-week treatment period and to observe the percentage of abstinent subjects during a 40-week follow-up post treatment.


Eligibility Criteria:
Inclusion Criteria:

* Smokers smoking at least 10 cigarettes/day as a mean within the 2 months preceding the screening visit
* Motivated to quit with a score greater than or equal to 6 on the ten-point Motivation Scale

Exclusion Criteria:

* Non tobacco cigarettes consumption
* Chronic use of marijuana
* Pregnancy, breastfeeding
* Any clinically significant disease that might interfere with the efficacy or safety evaluation of the study drug
* Concomitant use of drugs as an aid to smoking cessation or that might induce weight change
A Trial to Test the Efficacy of a Tailored Intensive Smoking Cessation Intervention in Persons With HIV (PWHs)

The purpose of this study is to determine whether an intensive, eight session behavioral intervention is superior to standard care in achieving abstinence from cigarettes in smokers living with HIV/AIDS.


Eligibility Criteria:
Inclusion Criteria:

* HIV-infection
* current cigarette smoker
* high motivation to quit

Exclusion Criteria:

* Pregnancy
* breastfeeding
Duramesh™ vs Polydioxanone Suture for Laparotomy Closure

This study is intended to demonstrate the non-inferiority of a Duramesh closure as compared to a polydioxanone closure for early surgical site events (SSE) (\< 1 month), and Duramesh superiority to polydioxanone for the development of incisional hernia by 1 year for a laparotomy closure.

This clinical investigation is designed to compare laparotomy closure with Duramesh to closure using PDS. The primary outcome is SSE that occurs within 1 month after surgery. Secondary outcomes that will be studied include device performance and technical success of the index-procedure, hernia occurrence/recurrence noted at 12 months after surgery, SSE and re-interventions that occur within 12 months of surgery, pain, implant palpability/sensation, surgeon and patient satisfaction, and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or greater
* Abdominal laparotomy 5 cm in length or greater, either midline or non-midline
* Isolated ostomy site takedown with or without parastomal hernia
* Patient accepts participation and gives informed consent
* Patient and investigator signed and dated the informed consent form prior to the index-procedure

Exclusion Criteria:

* Pregnancy
* Presence of clinically recognized hernia at laparotomy site (parastomal hernia noted at time of ostomy site takedown is not an exclusion criterion. Subclinical incidental small hernia \< 1 cm in greatest dimension found at the time of a laparotomy is not an automatic exclusion criterion)
* Prior hernia repair at laparotomy site
* Use of planar mesh in addition to sutures for closure
* CDC IV dirty or infected wound that causes the surgeon to leave the abdominal wall or skin incision open
* Life expectancy less than 1 year
* Patient is unable / unwilling to provide informed consent
* Patient is unable to comply with the protocol or proposed follow-up visits
* Patient is enrolled in another abdominal wall study
Impact of Respiratory Muscle Unloading on Respiratory Muscle Endurance

This study investigates how different degrees of muscular unloading during mechanical ventilation impact endurance of succeeding spontaneous breathing trials

Liberation from mechanical ventilation in difficult to wean patients is best accomplished by intermittent spontaneous breathing trials (1). Optimal respiratory muscle rest in-between breathing trials however has never been investigated.

Using a crossover design, patients are to be ventilated with complete and partial respiratory muscle unloading for a period of ten hours respectively. Respiratory muscle activity is being monitored by oesophageal balloon technique using a commercially available System (Avea, Viasys, Conshohocken, PA, USA). Time of spontaneous breathing, respiratory- and ABG parameters are being determined to characterize the course of each spontaneous breathing trial.

References

1. Esteban, A., F. Frutos, M. J. Tobin, I. Alia, J. F. Solsona, I. Valverdu, R. Fernandez, M. A. de la Cal, S. Benito, R. Tomas, and et al. 1995. A comparison of four methods of weaning patients from mechanical ventilation. Spanish Lung Failure Collaborative Group. N Engl J Med 332(6):345-50.

Eligibility Criteria:
Inclusion Criteria:

* hypercapnic respiratory failure

Exclusion Criteria:

* upper Gi pathology
* renal failure (creatinin \> 2 mg/dl)
* Sepsis or infection
* age \< 18 years
Comparing Intubation Rates in the Delivery Room by Interface

Although the majority of premature neonates \< 30 weeks gestion require positive pressure ventilation (PPV) at birth, the optimal interface to provide PPV has not been determined. Preferably this support would be provided by non-invasive means to prevent the development of bronchopulmonary dysplasia. Resuscitation with a face mask, single nasal tube, nasal prongs, and/or LMA are all approved methods of resuscitation per NRP as of 2010. Face masks have been associated with more dead space, air leak and airway obstruction however are the most commonly used interface. Recently, the Trigeminal Cardiac Reflex has been described, which can be induced with the placement of a facemask, resulting in bradycardia and apnea. Bi-nasal prongs (RAM cannula) have been found in studies to be associated with lower intubation rates in the delivery room (down to 24 weeks gestation), less need for epinephrine, chest compressions, and subsequent invasive ventilation. In addition to the potential practical advantages of bi-nasal prong resuscitation, there is evidence to suggest that ventilation through the nose may stimulate the subepithelial receptors of the upper airways causing an increase in respiratory rate and depth.


Eligibility Criteria:
Inclusion Criteria:

All resuscitated infants \< 30 weeks' gestation born at OSF SFMC

Exclusion Criteria:

Diagnosis of congenital diaphragmatic hernia No PPV needed, or no resuscitation desired due to major congenital anomalies or peri- viable status