cyrilzakka/clinical-trials huggingface dataset:
Study of SYH2062 Injection in Healthy Chinese Volunteers

The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacodynamics and pharmacokinetics of SYH2062 injection in healthy Chinese volunteers

A Phase 1, randomized, double-Blind, placebo-Controlled study to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of SYH2062 injection after a single administration in healthy subjects

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must give informed consent before the trial, fully understand the content, process and possible adverse reactions, and voluntarily sign a written informed consent.
2. Age of 18 - 55 years (inclusive).
3. BMI: 19.0-26.0 kg/m\^2 (inclusive), with a minimum weight of 50 kg (inclusive) for males and 45 kg (inclusive) for females.
4. Has Systolic blood pressure (SBP) ≥100 mmHg and \<140 mmHg and diastolic blood pressure (DBP) ≥60 mmHg and \<90 mmHg at screening;
5. The subjects can communicate well with the investigators and complete the trial according to protocol.

Exclusion Criteria:

Allergic constitution, or known history of allergy to the components of the study drug or similar drugs.

2 Subjects with the following diseases of clinical significance (including but not limited to diseases of the circulatory system, diseases of the blood or hematopoietic system, diseases of the respiratory system, diseases of the endocrine system, diseases of the urinary system, diseases of the digestive system, neurological or mental diseases, infections, tumors, serious injuries).

3 Those who underwent major surgery within 6 months prior to initial administration, or who planned to undergo surgery during the study.

4 Blood loss or blood donation of more than 200 mL within 3 months prior to initial administration (except for female menstrual period), and/or platelet donation within 2 weeks prior to initial administration.

5 Positive urine drug screening. 6 Those who smoked more than 5 cigarettes per day within 3 months prior to screening and/or did not agree to refrain from using any tobacco products during hospitalization.

7 Regular drinkers within 6 months prior to screening, i.e., those who drank more than 14 units of alcohol per week, and/or those who could not stop drinking alcohol during their hospitalization, and/or test positive for breath alcohol.
Glytactin EfficiEncy in Non or Insufficiently Treated Adult PHENylketonuria Patients

Phenylketonuria is the most common inherited metabolic disease in France and is screened for neonatal exposure. Management consists of a strict and restrictive hypoproteic diet and the intake of amino acid substitutes and dietary supplements free of phenylalanine.One of the major difficulties, which is the source of many treatment failures, is the inappetence of the amino acid supplements required during a strict hypoproteic diet. New formulations, Glycomacropeptides (GMP), have recently appeared and are considered more palatable than conventional amino acid mixtures.

Phenylketonuria is the most common inherited metabolic disease in France and is screened for neonatal exposure. Management consists of a strict and restrictive hypoproteic diet and the intake of amino acid substitutes and dietary supplements free of phenylalanine. If the benefits of treatment are indisputable in children in terms of cognitive prognosis, this benefit is discussed once brain development is complete, especially as many adult patients are no longer treated. However, cognitive, neurological and reversible white matter disorders undergoing treatment are increasingly reported in adult phenylketonurics. As a result, recent European recommendations advocate the maintenance of life-long treatment. One of the major difficulties, which is the source of many treatment failures, is the inappetence of the amino acid supplements required during a strict hypoproteic diet. New formulations, Glycomacropeptides (GMP), have recently appeared and are considered more palatable than conventional mixtures.

PRIMARY OBJECTIVE:

Demonstrate a better metabolic balance under GMP treatment than a conventional amino acid mixture in adult phenylketonuric patients when resuming treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patient age ≥18 years on an empty stomach
* Phenylketonuric patient Patient with Phenylalaninemia ≥ 900μmol / L on a blotter performed during the screening period (or average of blotter results ≥900 μmol / L if several blotters performed during the screening period)
* Untreated or insufficiently treated patient: not taking or insufficiently Dietary foods for special medical purposes for his PKU, regardless of diet, at the discretion of the investigator
* Patient having signed a free, informed and express consent
* Patient requiring a diet restricted in natural proteins

Exclusion Criteria:

* Protected patient: court bail
* Patient with concomitant diseases / conditions that may compromise the study, at the discretion of the investigator
* Participated in a clinical trial or trial to evaluate PKU foods or treatments in the last 7 days prior to inclusion or planned during the next 6 months
* Participation in an interventional study with health products during the next 6 months
* Pregnancy project within 6 months, pre-conception diet, pregnancy or breastfeeding
* Refusal to consume only validated complements for the protocol
* Phenylketonuria undergoing treatment with BH4
* Allergy to the product under study
Safety and Feasibility of Combined Trigeminal and Occipital Transcutaneous Nerve Stimulation (CTO-TNS) in Major Depressive Disorder (MDD)

Safety and Feasibility of Combined Trigeminal and Occipital Transcutaneous Nerve Stimulation (CTO-TNS) in Major Depressive Disorder (MDD)


Eligibility Criteria:
Inclusion Criteria:

* The subject is capable of understanding the study and to sign an informed consent.
* Subject is between the ages of 18 to 65 years old.
* Unipolar major depressive disorder
* Score on the Hamilton Depression Rating Scale (HDRS21) \> 22
* Current MDD episode \>3 months
* Nonresponse with \>6 week use of one to six antidepressant in current episode

Exclusion Criteria:

* History of neurosurgical interventions.
* Subjects with metal implants or shrapnel in their head, except for dental implants.
* Skin lesion or inflammation at the region of the stimulating electrodes.
* Pregnancy or Lactation.
* Women of reproductive age not using efficient contraceptive method.
* History of cerebrovascular event.
* Psychotic or bipolar depression
* History of schizophrenia, schizoaffective disorder or other non-mood disorder psychosis
* Current delirium, dementia, amnestic disorder or other cognitive disorders
* Clinically significant current suicidal intent as assessed by the investigator team.
* Obsessive-compulsive disorder or post-traumatic stress disorder
* Alcohol and non-alcohol psychoactive substance abuse or dependence
* Significant cardiac, medical, or progressive neurological or medical illness
* An implantable electrical device such as a pacemaker.
Evaluation of Synthesized 18-Lead ECG in the Emergency Department

This study, sponsored by Nihon Kohden, aims to determine the sensitivity and specificity of synthesized 18-lead electrocardiogram (ECG) in the diagnosis of posterior-lateral and/or right-ventricular ischemia, using actual 18-lead ECG as the gold standard. The synthesized 18-lead ECG calculates six extra leads of information from the standard 12-lead ECG done in the Emergency Department (ED). Nihon Kohden has created synECi18 Technology, which can mathematically synthesize and display the extra leads.

The patient population (n=300) will consist of patients who present to the North Shore University Hospital or Long Island Jewish Medical Center ED with a chief complaint of chest pain, chest pressure, or chest discomfort. These patients will be receiving a standard 12-lead ECG as part of their routine clinical care. Patients with ST-Elevation Myocardial Infarction (STEMI) and a known positive troponin value will be excluded from the study.

Trained ED study technicians will use ECG machines provided by Nihon Kohden to obtain two consecutive 15-lead ECGs. The two 15-lead ECGs are then saved onto the ECG machine.The saved information will later be input into an algorithm to calculate the synthesized 18-leads. The actual 18-leads (composed of the two 15-leads conducted in the ED) will be compared with the synthesized 18-leads produced by the synECi18 technology. A study cardiologists will evaluate the actual 18-lead ECGs and synthesized 18-lead ECGs and determine whether there is posterior-lateral and/or right-sided ventricular ischemia. The cardiologists will be blinded to the type of waveform they are analyzing (synthesized versus actual).

The study will not interfere with patient care or treatment, however, the two 15-lead ECGs done in the ED will be shown to the physician who can determine whether or not to order an official 18-lead ECG in the hospital's electronic medical record system.

It is hypothesized that the synECi18 synthesized 18-lead ECGs will provide high sensitivity and specificity for diagnosing posterior-lateral and/or right-ventricular ischemia, with the actual 18-lead ECGs being used as the reference for comparison.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a chief complaint of chest pain or chest discomfort or chest pressure
* Troponin test has been ordered (unknown positive at time of recruitment)
* Subjects are capable of providing informed consent
* English speaking

Exclusion Criteria:

* STEMI patients
* Patients who have not had a troponin test ordered
* Pregnant women
* Patients under 18 years of age
* Prisoners
Intestinal Microbiome and Psychological Correlates in Irritable Bowel Syndrome and Inflammatory Bowel Disease

Longitudinal Investigation of intestinal microbiome, fecal inflammation markers, stress and psychological variables in patients with irritable bowel syndrome and inflammatory bowel disease undergoing gut-directed hypnotherapy (GHT).

Study design is a within-subject design with assessment at 4 points in time. Data will be collected 3-1 month before first GHT session (T1), immediately before first session (T2), at the last session (T3), and 3-6 months after last session (T4).

Study patients will be recruited consecutively at the special outpatient-clinic for psychosomatics at the division of Gastroenterology and Hepatology, department for Internal Medicine III, University Hospital Vienna.

Patients undergo GHT in group setting, which has been shown to reduce irritable bowel syndrome (IBS) symptoms and to increase psychological wellbeing. The GHT protocol used will be the Manchester protocol of gut-directed hypnotherapy and consists of 10 weekly sessions (45 minutes) with six up to eight patients per group over a treatment period of 12 weeks.

The following variables will be assessed using standardized questionnaires: anxiety and depression (HADS-D), perceived stress (PSQ), resilience (CDRISC), and quality of life (visual analogue scales). IBS symptoms will be captured by the IBS Severity Scoring System (IBS-SSS), inflammatory bowel disease (IBD) disease activity via Harvey-Bradshaw-Index. Additionally, medication intake and food supplements will be assessed.

Microbiome data will be gained by frozen stool samples, collected by patients at home. Patients will be provided with a delivery kit to keep the samples frozen. Patients are asked to collect the first stool of the day and not to change diet, medication and intake of pre/probiotics during the hole study period, if possible (documented). At each time point (T1-T4) patients are ask to bring two immediately frozen (stored in their home freezer) double samples (2 stool samples within 1 week) to the hospital to be immediately stored at minus 20 degree Celsius. If patients do not have a home freezer, stool will be collected and frozen at the hospital.

Planned analyses comprise longitudinal and cross-sectional comparisons Intestinal colonization will enter in the analyses according to an algorithm assigning values for an increase or reduction of dysbiosis. Dysbiosis is hereby defined by the following markers: reduction of fecal biodiversity, lowered occurrence of the species Bifidobacterium, Lactobacillus and Faecalibacterium prausnitzi, increased occurrence of Enterobacteriaceae, and a higher quotient Firmicutes:Bacteroidetes.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of IBS or IBD
* Eligible for gut-directed hypnotherapy
* Adult age (18-89)
* Sufficient knowledge of german language

Exclusion Criteria:

* Severe somatic or psychiatric illness
* Operations of the GI tract
Effects of a Stretching Protocol in Patients With Hip Osteoarthritis

Hip osteoarthritis (OA) is one of the most prevalent chronic disease in the world. Clinical guidelines recommend non-pharmacological conservative treatments for the management of OA. Hip flexors seems to play an important role in the development of hip OA but there is no published studies evaluating the results of a stretching protocol of hip flexors in hip OA patients.

The objective of this trial is to evaluate if a stretching protocol of hip flexors is more effective in symptoms, functional capacity , range of motion, strength, muscular length, pain threshold and anxiety and depression compared to control.

For this purpose the investigators conduct a single-group, pretest-posttest clinical trial.The investigators included patients diagnosed of hip osteoarthritis Grade I-III by Scale of Kellgren and Lawrence.

The variables are measured at the beginning and at the end of treatment of the control phase, and at the end of the stretching protocol phase.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed medically with a X-Ray test
* American College of Rheumatology Criteria

Exclusion Criteria:

* Secondary osteoarthritis by a traumatism, Paget disease, inflammatory or metabolic disease, congenital diseases etc.
* Vascular or neurological disease.
* Musculoskeletal pathologies in lumbar spine, pelvis or lower limbs
* Grade IV in Kellgren and Laurence Scale
Sinus Tarsi Versus Extensile Lateral Approach for Calcaneus Fractures

This study is a prospective, randomized controlled trial comparing the sinus tarsi approach to the extensile lateral approach for surgical fixation of calcaneus fractures.

It is hypothesized that open reduction and internal fixation of intra-articular calcaneus fractures using a sinus tarsi approach will provide equivalent fracture reduction and stable fixation with significantly decreased wound complication rates in comparison to an extensile lateral approach.


Eligibility Criteria:
Inclusion Criteria:

* Skeletally mature patients ≥ 18 years of age
* Closed intra-articular calcaneus fractures
* Undergoing surgical fixation (CPT code 28415)
* Ability to understand and agree to informed consent

Exclusion Criteria:

* Patients \< 18 years of age
* Open fractures
* Dislocations that require open reduction
* Previous calcaneus abnormality or injury
* Unable to understand or agree to informed consent
Comparative Study Between Two Adjuvant Drugs to Bupivacaine for Post-operative Epidural Analgesia in Abdominal Surgeries

Epidural analgesia is associated with early postoperative mobilization and rehabilitation with minimally associated pain and discomfort. Analgesic effect of local anesthetics is augmented by addition of adjuvants in epidural anesthesia ensuring satisfactory postoperative period. This study evaluates the effect of dexmedetomidine and fentanyl as additives to bupivacaine for epidural analgesia.

The aim of the study is to evaluate the effect of dexmedetomidin and fentanyl as adjuvants to bupivacaine for postoperative epidural analgesia in abdominal surgeries regarding block characteristics, post-operative analgesia, hemodynamic changes and any anticipated side effects.

* Type of Study: Prospective randomized comparative clinical study.
* Study Setting: The operating theatres of Ain Shams University Hospitals
* Study Period: One year
* Sampling Method: Random sampling Patients randomly allocated by computer generated randomization and using opaque sealed envelopes to one of the three study groups according to the adjuvant drug used in postoperative analgesia.
* Sample Size: Total 75 cases divided into 25 cases in each group. Kiran et al. (2018) reported a rather large effect size comparing onset to sensory block and time to maximum motor block. In a one-way ANOVA study, sample sizes of 25 cases per group in three groups whose means are to be compared. The total sample of 75 subjects achieves 80% power to detect differences among the means versus the alternative of equal means using an F test with a 0.0500 significance level. The size of the variation in the means is represented by the effect size = 0.4

Eligibility Criteria:
Inclusion Criteria:

* ASA I or ASA II patients.
* Age group: 21-70 years old.
* BMI ≤40
* Duration of procedure ≤ 180 minutes.

Exclusion Criteria:

* Patients with known neurologic and psychiatric illness will be excluded from the study.
* Contraindications for epidural anesthesia as patient refusal, bleeding or coagulation test abnormalities, local skin infection at spinal lumbar region, raised intracranial pressure and hypovolemia
* Spine abnormalities.
* Systemic disorders like hematological, respiratory, cardiac, renal or hepatic insufficiency.
* Allergy to any of the drugs used in the study.
Bausch Health Thermage FXL for Use on Lower Face and Submentum Area

This study is designed to evaluate the safety and efficacy of sequential use of monopolar radiofrequency on lower face and submental area, followed by cryolipolysis on the submentum and submandibular area for fat reduction and improvement of skin laxity.

This research study will study subjects who have mild to moderate skin laxity on lower jaw and submentum areas. This will be measured by conducting a treatment using the Thermage FLX system on the lower face and submentum area of the participants. Biopsies will be done on several locations throughout the 12 week trial to assess skin laxity through laboratory measures. Finally, the subject will be asked to complete questionnaires to provide satisfaction and tolerability feedback.

Eligibility Criteria:
Inclusion Criteria:

* Female subjects \> 40 years of age and \< 80 years of age.
* Presence of mild to moderate skin laxity on lower face and submentum area, which in the investigator's opinion may benefit from monopolar radiofrequency to improve the skin laxity for a youthful, rejuvenated appearance.
* BMI under 35.
* Agreement to maintain their weight within 5 lb of the baseline.
* Subject has read and signed a written informed consent form.

Exclusion Criteria:

* Subject has severe skin laxity in the area of intended treatment which in the opinion of the investigator, may result in an unacceptable aesthetic result.
* Subject has had a surgical procedure(s) in the area of intended treatment.
* History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.), in or around the area of intended treatment.
* Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
* Currently taking or has taken diet pills or weight control supplements within the past month.
* Any dermatological conditions, such as scars, infection, in the location of the treatment area that may interfere with the treatment or evaluation.
* Active implanted device such as a pacemaker, defibrillator, or drug delivery system.
* Pregnant or intending to become pregnant in the next 6 months.
* Lactating or has been lactating in the past 6 months.
* BMI ≥ 35.
* Unable or unwilling to comply with the study requirements.
* Currently enrolled in a clinical study of any other unapproved investigational drug or device.
* Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
Molar-Incisor Hypomineralization Vs Periodontal Health

Background: To investigate the effect of molar incisor hypomineralization (MIH) on periodontal health, to evaluate the relationship between gingival crevicular fluid (GCF) volume, and GCF biomarkers such as matrix metalloproteinase-8 (MMP-8), matrix metalloproteinase-20 (MMP-20), and transforming growth factor-beta 1 (TGF-β1), and MIH.

Methods: The study was conducted on 40 pediatric patients diagnosed with MIH (Study Group/SG), and 40 pediatric patients healthy for MIH (Control Group/CG). Clinical periodontal measurements (plaque index (PI), gingival index (GI), probing pocket depth (PPD), and GCF volume were performed. Concentrations of MMP-8, MMP-20, and TGF-β1 in GCF were determined using enzyme-linked immunosorbent assay (ELISA). Mann-Whitney U test and T-test were used for comparisons between groups. Significance was set at p=0.05 for statistical analysis.


Eligibility Criteria:
Inclusion Criteria:

* the ages of 8 and 14 who were diagnosed with MIH in their maxillary permanent first molars,
* had healthy maxillary permanent first molars,
* scored 3 (positive) or 4 (definitely positive) on the Frankl Behavior Scale,
* had no mental or physical disability,
* did not need urgent treatment and/or were not in pain,
* agreed to participate in the study with their parents and signed the consent form.

Exclusion Criteria:

* Children with systemic, chronic, and/ or metabolic diseases,
* under active orthodontic treatment, with developmental defects of enamel (excluding MIH), or born prematurely
Safety and Efficacy Study of MRE0094 to Treat Large, Single or Multiple, Chronic, Neuropathic, Diabetic Foot Ulcers

This is a clinical research study of an experimental topical drug for the treatment of chronic, neuropathic, diabetic foot ulcers. The purpose of the study is to determine the safety of the experimental drug when applied to large, diabetic foot ulcers. The study will also determine if the experimental drug can safely promote healing of diabetic foot ulcers better than standard treatments currently available to doctors.

Patients participating in the study may receive an active drug (MRE0094) or inactive drug (placebo). What treatment a patient will receive is determined by chance (like drawing a number from a hat). All patients will receive additional care for diabetic foot ulcers during the study.

Participation in the study can be up to 4½ months.


Eligibility Criteria:
Inclusion Criteria:

Participants included in the study must:

* Have type 1 or type 2 diabetes mellitus.
* Have problems with the nerves in their feet.
* Have a large ulcer or multiple ulcers on the bottom surface of their foot that has been present for 3 weeks or more and is of sufficient size to qualify for the study.
* Be able to apply study drug to their ulcer, or have a caregiver do it.
* Be able to visit the doctor regularly during the 4½ month study.

Exclusion Criteria:

Participants may not participate in the study if:

* Their ulcer is caused by bad blood flow to their foot.
* Their ulcer is infected.
* They cannot wear an off-loading device during the study to take pressure off the ulcer.
* They have certain other diseases, or are using certain types of drugs.
Post-hospitalisation Nutritional Support and Gait Speed in COPD

To determine the feasibility of delivering different community nutritional interventions to chronic obstructive pulmonary disease (COPD) patients at moderate or severe risk of malnutrition following a hospitalisation for an acute exacerbation of COPD.


Eligibility Criteria:
Inclusion Criteria:

* Ability to consent
* Patients at moderate or severe risk of malnutrition
* Adults over the age of 40
* Hospitalised with an AECOPD

Exclusion Criteria:

* Receiving long term parental or enteral nutrition
* Inability to swallow or difficulty liquids
* Lactose intolerance, galactosaemia, cow's milk protein allergy or intolerance
* Co-existing active cancer, progressive neurological condition or active GI disorder.
* Receiving palliative care with expectation of death within 3 months
* Cognitive dysfunction or unable to consent