cyrilzakka/clinical-trials huggingface dataset:
Study to Validate the Questionnaire Called IDSIQ™ in Patients With Insomnia Disorder

The main study objective is to assess the content validity and the psychometric characteristics of the Insomnia Daytime Symptoms and Impacts Questionnaire™ (IDSIQ™).

Zolpidem will be used as an active intervention to assess the sensitivity to change of IDSIQ™ in patients suffering from insomnia disorder.

IDSIQ™ will be administered during the screening period (within 14 days before enrollment in the study) and the treatment period (from Day 1 to Day 14). End of study (phone call) will take place 30-37 days after the end-of-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent prior to any study-mandated procedure;
* Male or female aged ≥ 18 years;
* Body mass index (BMI): 18.5 ≤ BMI (kg/m2) \< 32.0;
* Insomnia disorder according to DSM-5 criteria;
* Insufficient sleep quantity evaluated according to the self-reported history and data collected in the sleep diary;
* Insomnia Severity Index score greater than or equal to 15;
* Complete the IDSIQ™ and the sleep diary questionnaire as required.

Exclusion Criteria:

* Any current history of sleep disorder other than insomnia, or any lifetime history of related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement behavior disorder, or narcolepsy;
* Self-reported usual daytime napping ≥ 1 hour per day, and ≥ 3 days per week;
* Caffeine consumption ≥ 600 mg per day;
* Shift work within 2 weeks prior to the screening visit, or planned shift work from V1 to V3;
* Travel ≥ 3 time zones within 1 week prior to the screening visit, or planned travel ≥ 3 time zones from V1 to V3;
* Known severe renal impairment or know moderate or severe hepatic impairment;
* History or clinical evidence of any disease or medical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the study assessments;
* Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.
A Study on the Effects of VR-3 Herbal Blend Intake on Acute and Chronic Stress in Healthy Adults

The purpose of this study is to determine the safety and efficacy of VR-3 Herbal Blend and its effects on acute and chronic stress responses.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women between the ages of 35-45
2. No health concerns as determined by study physicians
3. Women must not be pregnant or become pregnant for the duration of the study.

Exclusion Criteria:

1. The subject has a history of hypersensitivity to any of the compounds used in the study
2. The subject is pregnant or a lactating female. Note: If the potential subject is a post-menarcheal female, a pregnancy test (urine or serum) must be performed within 24 hours of study drug administration and confirmed negative in order for the potential subject to be enrolled).
3. History of Psychiatric Illness or Chronic Stress or Anxiety
4. Hypertension, cardiovascular disease, or other health concerns that may confound study results
5. Allergy or sensitivity to test product or ingredients
6. Individuals who are cognitively impaired or who are not able to give informed consent
7. Clinically significant or abnormal laboratory result that can confound the study
8. Medication or nutraceutical intake that can interact with the adaptogens or the biomarkers used in the study (to be determined by study physician)
9. Previous participation in a clinical research trial within 30 days prior to randomization
10. The subject has an ongoing abuse of illicit substances, alcohol, or actively smoking marijuana.
11. The subject is actively engaging in the use of Herbal Medicine, Traditional Chinese Medicine, Ancient Indian Medicine, Yoga, or Ayurveda
Preliminary Efficacy and Safety Study of Oral Nepadutant in Infant Colic

This phase IIa study is designed as a multi-centre, multinational, randomised, double-blind, placebo controlled study in three parallel groups, with the aim to evaluate the efficacy and safety of Nepadutant given at two oral doses once daily for seven days in comparison to placebo in the treatment of infantile colic.

Infant colic is a functional gastrointestinal disorders which affects up to the 30% of the infant population; it is primarily characterised by excessive inconsolable crying starting without any apparent cause and lasting for several hours per day.

Current non pharmacological interventions (e.g. message, restriction in maternal diet in breast-feeding infants) and pharmacological treatments (simethicone, antimuscarinic drugs) are largely unsatisfactory.

In animal models, Nepadutant reverse the exaggerated intestinal motility and sensitivity, induced by different stimuli, without producing inhibitory effects on these functions at baseline, suggesting that Nepadutant could have a therapeutic effect with no interference on physiological gastrointestinal transit.

This phase IIa study is designed to evaluate the efficacy of Nepadutant paediatric oral solution given once daily at two doses in comparison to placebo.

The experimental clinical phase encompasses the following periods:

* Screening period (no study medication) to be done 7 to 4 days prior to randomisation
* Treatment period, lasting seven days with once daily administration
* Post treatment period, lasting seven days A safety follow-up visit will be performed approximately 1 month after the first administered dose.

Eligibility Criteria:
Inclusion Criteria:

* Healthy infants with diagnosis of infant colic according to the following modified Wessel criterion "paroxysm of irritability, fussing or crying that start and stop without obvious cause for \>3h/day, \>3 days/week for one week"
* Age \> 4 weeks and \< 20 weeks
* Infants breast-fed mixed fed or formula fed with a stable dietary regimen
* Normal growth
* History of no adequate response to conventional treatment alternatives which make the infants in need of medical treatment
* Willingness to refrain from use of antimuscarinic drugs, simethicone, dimethicone or antiacids during the study period.

Exclusion Criteria:

* Clinical evidence of allergies or other diseases which may cause crying and/or fussiness or may interfere with absorption or clearance of the drug.
* Suspect of gastroesophageal reflux disease (GERD)
* Suspect of cow milk allergy.
Randomized，Controlled and Open-label Study of Buspirone add-on Treatment in Patients With Major Depression Disorder

This is a Multicenter, open lable, parallel randomized controlled clinical trial.

This study aimed to evaluate the treatment onset time, efficacy and safety in patients with major depressive disorders , accompanying anxiety receiving Buspirone and Paroxetine.


Eligibility Criteria:
Inclusion Criteria:

1. Patients meeting Statistical Manual of Mental Disorders IV (DSM-IV) criteria for major depression disorder , Hamilton Depression Rating Scale(HAM-D) score was 17 or above, Hamilton Anxiety Scale（HAMA）score was 7 or above.
2. aged 18-65 years( including 18,65 years )
3. male and female and inpatient as well as outpatient.
4. Written informed consent was obtained from each patient before therapy. -

Exclusion Criteria:

1. Patients with pregnant or breast-feeding and not taking effective contraceptive measures
2. Patients were allergic to buspirone or with a known intolerance to contraindication
3. Patients with clinically severe and unstable disease ,and not suitable to participate the study judged by the investigators
4. Patients with nervous system diseases(such as epilepsy, Brain injury, Multiple Sclerosis, Degenerative disease including acute lateral sclerosis, Parkinson's disease, ataxy)
5. Patients with a mental illness according to the DSM-IV, such as Organic mental disorders, Schizophrenia, Shizoaffective disorder, delusional disorder, Undifferentiated schizophrenia, bipolar disorder, and patients with a history of substance abuse including alcohol and active drug within 12 months of screening.
6. Patients are taking other Psychiatric drugs (such as Antipsychotic drugs, Anticonvulsant and Mood stabilizer but not include Antihistamine agents) and receiving ECT that might be excluded.
7. Patients worked on professional drivers or dangerous works
8. Patients participated in clinical trials within the past 30 days and treated with drugs from sponsors are not eligible.
9. Patients with clinically significant abnormalities on electrocardiogram or laboratory tests
10. Patients with Acute Angle-closure Glaucoma
11. Patients with Myasthenia Gravis
12. Patients who have used Monoamine oxidase inhibitors (MAOI) within 2 weeks of Screening
13. Patients who were Refractory depression invalid or non-responsive to adequate dosage (therapeutic dose upper limit) and duration (up 6 weeks) with two or above different antidepressants.
14. Patients who pose a suicidal risk, HAMD suicide score was 3 or above . -
The STandard Versus ImAging SuBstrate Aided Ablation in Severe Left VEntricular Dysfunction VT.

The STABLE-VT trial aims to determine the safety profile and clinical efficacy of a modified approach to ventricular tachycardia (VT) ablation that integrates myocardial scar as visualized on cardiac magnetic resonance (c-MRI) or CT into electroanatomical mapping (EAM) for VT ablation.

The STABLE-VT trial aims to integrate myocardial scar as visualized on cardiac magnetic resonance (c-MRI) or CT into electroanatomical mapping (EAM) for VT ablation. Particularly, we will compare the procedural safety, and acute and long-term clinical efficacy of this imaging-aided VT ablation protocol to standard of care.

Our hypothesis is that patients with ventricular tachycardia (VT) and severe LV dysfunction randomized to this imaging-aided protocol will have shorter procedure duration, improved procedural hemodynamic stability, fewer acute major adverse cardiovascular events (MACE), less need for mechanical support, comparable freedom from VT at noninvasive programmed stimulation (NIPS) sub-acutely after the procedure, and at two-year follow-up compared to standard ablation approach. Herein, our outcomes of interest will be captured during the two years following as part of regular standard of care follow-ups.

Eligibility Criteria:
Inclusion Criteria:

* Patients (\>18 years old) diagnosed with severely reduced ejection fraction defined as EF≤25% or EF≤ 35% with concurrent NYHA class III/IV heart failure symptoms and/or at least one previous heart failure hospitalization in the previous 6 months) who are referred for VT ablation.
* Patients with moderate to severe RV dysfunction diagnosed on most recent imaging (echo/c-MRI).
* Patients with must have undergone the imaging (c-MRI and/or CT) required for the investigational VT approach to qualify for participation.

Exclusion Criteria:

* Patients in whom Impella/ECMO or anesthesia is indicated prior to or at presentation to the EP lab.
* Patients for whom an informed consent cannot be obtained.
* Patients who are found to be pregnant using detection of human chorionic gonadotropin (hcg) as done as part of standard of care, will be excluded.
Cytogenetic and Molecular Genetic Studies in Bone Sarcomas

To establish a serial ascertainement of specimens from patients with bone sarcomas to be used in ongoing cytogenetic and molecular genetic analyses. These data will be integrated and correlated with the established Orthopaedic Service clinical database.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be undergoing diagnostic biopsy or resection of their primary or metastatic bone sarcoma for therapeutic purposes.
* The specimen must be large enough to allow routine pathological analysis, with the specimen for research excised from residual tissue that would otherwise be discarded.

Exclusion Criteria:

* N/A
Quality of Handover to a Post Anaesthesia Care Unit in a Children's Hospital

Postoperative handovers to the post anaesthesia care unit (PACU) in adult anaesthesia are described as incomplete and unstructured, although their relevance for the patient safety is well known. It must be assumed that for children, this handover is at least comparable important.

With a self-developed checklist information transfer during postoperative handovers will be documented and subsequently compared with patient information in anaesthesia records.


Eligibility Criteria:
Inclusion Criteria:

* All patients transferred to the PACU after surgery

Exclusion Criteria:

* Age \> 18 years
Using Radiogenomics to Predict Malignant Potential of Intraductal Papillary Mucinous Neoplasms of the Pancreas

The Florida Pancreas Collaborative wants to partner with individuals who are known to have, or are suspected to have a pancreatic lesion, tumor, cyst, mass, cancer, or pancreatitis and are undergoing diagnosis and treatment at a participating institution. The goals of this project are to build a large database of information obtained from blood, tissue, medical images, surveys and information from routine care to develop noninvasive diagnostic approaches that could be used as decision-making tools to effectively personalize clinical care.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who present to the GI clinic, surgery, or endoscopy at Moffitt, Florida Research Institute (FRI), or UM with a clinical suspicion for (or diagnosis of) a pancreatic lesion, cyst, mass, cancer, or pancreatitis based on symptoms, imaging, or blood-work and has not had any treatment involving their pancreas.
* Able to understand and voluntarily sign the informed consent.
* Willing to complete study questionnaire(s) and donate medical images and/or biological specimens (including blood, cystic fluid, and/or tissue) obtained at the time of standard of care procedures (biopsy, surgery, and venipuncture) after signing the informed consent document

Exclusion Criteria:

* No suspicion or diagnosis of a pancreatic lesion, cyst, mass, cancer, or pancreatitis.
* Has a diagnosis of a pancreatic lesion, cyst, mass, cancer, or pancreatitis and has already undergone treatment involving the pancreas (which may involve surgery, chemo- or immuno-therapy, and/or radiation).
* Unable to provide informed consent.
* Unwilling to complete study questionnaire(s) and/or donate biological specimens or images.
Clinical Evaluation of Bulk-fill Restorative Materials

High-viscosity glass ionomer cements have been developed to improve the weak mechanical properties of glass ionomer cements, increase wear resistance and improve their limited indications. There are limited clinical studies on the use of high-viscosity glass ionomer cements in areas with large cavities bearing stress. The aim of this study is to compare the clinical performance of two different high-viscosity glass ionomer cements with a bulk-fill resin composite in different cavities.

This study was a double-blind (evaluator and patient) randomized controlled clinical study with three study groups with an equal allocation. Three different restorative materials were compared in Class I, II, and V restorations.

The treated patients were called back for controls after one week, six months, and eighteen months. Restorations were evaluated clinically according to modified FDI criteria. In terms of marginal discoloration, fracture and retention, marginal adaptation, post-operative sensitivity, secondary caries, color match and difference criteria were examined.

Clinical evaluation was performed by one qualified clinicians using a mirror and probe under reflector light. Bite-wing radiographs were taken from the patients who were called for controls at 6-moth and 18-month to evaluate the formation of secondary caries.

Differences between adhesives at each time period were evaluated using Fisher's Exact test. The effect of time on restorations was evaluated using Wilcoxon Signed rank test (p \< 0.05).

Eligibility Criteria:
Inclusion Criteria:

* Voluntarily agreed to participate in the study after being informed about the study.
* Volunteer must not be under 18 years of age
* No systemic disease
* Having healthy oral hygiene
* As a result of clinical and radiographic examination, there is a carious lesion at D1 and D2 levels according to the caries classification method.
* The tooth to be restored is vital

Exclusion Criteria:

* Refusal to participate in the study after being informed about the study
* The patient has a history of teeth grinding
* Volunteer must be under 18 years of age
* The volunteer is undergoing or will begin orthodontic treatment
* The volunteer has a serious systemic disease
* The tooth to be restored has endodontic and periodontal problems
* Volunteer's pregnancy status
* Extraction of one of the teeth opposite or in contact with the tooth to be restored
Effectiveness of Basketball Pre-injury Attack Program to Reduce the Susceptibility of Injury in Youth Basketball Players

Basketball is an impact, coordination-opposition sport with continuous contact among players and it is considered a sport of medium-high injury incidence. Players are force to have a physical condition appropriate to their practice and the demand to which they must respond due to the intensity of the efforts this sport requires. In order to achieve this, it is necessary to establish an evaluation protocol that allows the detection of functional deficiencies, to guide and conduct in a specific and early way every moment of players' health and growth.

The purpose of this study is to design, apply and analyze the effectiveness of a specific and individualized therapeutic exercise program (Basketball Pre-injury Attack) based on the approach of the functional deficiencies detected by the Basketball Injury Defense, to reduce the susceptibility to injury of youth basketball players (U14 - U17).

The aim of this study is to design, apply and analyze the effectiveness of a specific and individualized therapeutic exercise program (Basketball Pre-injury Attack) based on the approach of functional deficiencies detected by the Basketball Injury Defense, to reduce the susceptibility to injury of training federated basketball players.

The specific objectives are:

To improve the deficiencies detected in mobility, stability, symmetry and jumping/landing technique of basketball players in training categories (U14, U16 and U17).

To structure and determine the contents of a specific and individualized therapeutic exercise program (Basketball Preinjury Attack) designed to improve the functional deficiencies of mobility, stability, symmetry and jumping/landing technique of training basketball players based on current scientific evidence.

To analyze whether adherence to the program is achieved by raising players' awareness of the importance and benefits of performing the exercises with correct technique.

To assess whether a decrease in the susceptibility to injury of training federated basketball players is achieved.

For this purpose, an experimental study was conducted as a single-blind, randomized, cluster-controlled clinical trial during the months of June 2019 to February 2020 (9 months). For the development of the methodology of this study, the guidelines of the CONSORT (Consolidated Standards of Reporting Trials) Statement were followed.

Eligibility Criteria:
Inclusion Criteria:

* Be between 10 and 17 years old
* Be an active player at the time of selection
* Sign the informed consent.

Exclusion Criteria:

* Being diagnosed with a psychological and/or psychiatric illness.
* Being diagnosed with an oncological disease.
* Be injured at the time of selection.
Review of Pain Management After Congenital Cardiac Surgery

One of the main problems that faces children undergoing congenital cardiac surgery is posoperative pain management. PCAs (Patient Controlled Analgesia) and NCAs (Nurse Controlled Analgesia) are the main means of pain management here at NCH. In this study, the investigators will review the difference between different PCA and NCA modalities. Also, the investigators aim to find out if there are differences between age groups in terms of type of drug used, total drug used, side effects and length of use of the PCA or NCA.

All patients that underwent congenital cardiac surgery from 2004 till 2010 and required PCA or NCA will be included. Data will be collected from the pain team database and charts review. Data will include; patient's age, weight, sex, procedure, pain scores and sedation score during the times of PCA and NCA use, side effects (respiratory depression, nausea, vomitting, pruritus, itching and other).In addition we will record the total days of PCA and NCA use. We will also look at the incidence of changes done in the PCA/NCA and drug itself.

Identifying the ideal drug and dose based on the patient's age and procedure will allow us to take better care of our patients. Our patient population is peculiar in the fact that a big percentage of our patients are extubated in the Operating Room. For this reason, sedation and analgesia play an important role for our continued success in taking care of them.

Eligibility Criteria:
Inclusion Criteria:

* All patients that underwent congenital cardiac surgery from 2004 till 2010 and required PCA or NCA.

Exclusion Criteria:

* All patients that underwent congenital cardiac surgery from 2004 till 2010 and did not receive PCA or NCA for postoperative pain management.
Effect of Lithium Carbonate in Patients With Amyotrophic Lateral Sclerosis

The purpose of the study is to determine whether lithium is safe and effective in the treatment of ALS

Daily doses of lithium, have been found to delay progression of amyotrophic lateral sclerosis (ALS) in a 15-month study of 44 patients with ALS. At the end of the trial, about 30 percent of the patients that took riluzole had died, while all those receiving riluzole plus lithium had survived. the lithium group had slower progression as measure by a test of breathing (FVC) and strength.

This study will determine whether lithium in combination with riluzole delay progression of patients with amyotrophic lateral sclerosis disease in comparison of an historical cohort of ALS patients treated with riluzole alone.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of clinically possible, clinically probable laboratory-supported, clinically probable or clinically definite ALS (according to WNF EL Escorial diagnostic criteria, revised according to the AIRLIE House Conference 1998)
* Concomitant standard Riluzole therapy (50mg twice daily)
* patients included in ALS reference center
* women of childbearing age be non-lactating and surgically sterile or using a highly effective method of birth control and have a negative pregnancy test
* capable of thoroughly understanding all information given and giving full informed consent according to GCP
* Patients with gastrostomy

Exclusion Criteria:

* evidence of major psychiatric disorder or clinically evident dementia precluding evaluation of symptoms
* any medical condition known to contre-indicate lithium treatment (dysthyroid, cardiopathy, renal insufficiency)
* presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment
* known hypersensitivity to any component of the study drugs