cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Essential Metal Metabolism

Disturbance of consciousness (DoC) is a state in which consciousness is altered following brain damage and can manifest in several conditions that result from the loss of regulation of the neural function of the two components of consciousness, alertness and awareness.

It is known that the main causes of disorders of consciousness have important effects on the disruption of essential metal homeostasis.

In particular, myocardial infarction and heart failure, ischemic and hemorrhagic stroke and head trauma trigger phenomena of diffuse axonal damage, hypoxia and re-perfusion that profoundly alter the metabolism of cerebral O2 that reacts with essential metals , in Fenton-type reactions whose predominant effect is an extensive production of reactive oxygen species (ROS) and pro-oxidant molecules.

Fe, Cu and zinc (Zn) are essential metals for life: two thirds of the proteins in our body use these metals that play a crucial role as catalysts or structural elements of proteins in various biological processes, such as cellular respiration in mitochondria, the production and maturation of red and white blood cells, the elasticity of connective tissue, the production of myelin and the production of some neurotransmitters. For this reason, the biology of essential metals has a major impact on our health and the disruption of their homeostasis inexorably leads to disease.

These metals are very important for the metabolism of the Central Nervous System (CNS) and Cu, in particular, even in adults, is involved in the production of myelin and in the production of some neurotransmitters of the diffuse modulatory systems . Cu is a cofactor of the enzymes dopamine β-hydroxylase, and monoamine oxidase involved in the balance of catecholamines , and is altered in some disorders of Cu metabolism.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have been in a coma state, documented with a GCS ≤ 8 for at least 24 hours;

  * Presence of a disturbance of consciousness, identified through the Coma Recovery Scale-revised (CRS-r) and classified as coma, vegetative state or minimally conscious state;
  * Latency of the acute event between 15 days and 6 months;
  * Ability of the caregiver/guardian to understand and sign the informed consent.

Exclusion Criteria:

* Age \<18 years;

  * Psychiatric or other pathologies;
  * Inflammatory state related to ongoing infections;
  * Refusal or inability to sign the written informed consent to participate in the study.
The Effectiveness of Simethicone In Improving Visibility During Colonoscopy

Sodium phosphate is one of the bowel preparation regimens for colonoscopy. However, intraluminal gas can impair visibility during the examination. Simethicone is medication that works by reducing the surface tension of air bubbles. We aimed to evaluate the effect of simethicone in enhancing visibility and efficacy during colonoscopy.

A prospective, randomized, double-blinded, placebo-controlled study was conducted. One hundred and twenty-four patients were allocated to receive 2 dosages of either 45 ml of sodium phosphate plus 240 mg of simethicone tablets or 45 ml of sodium phosphate plus placebo in the evening before and in the morning of the procedure day. The colonoscopic examination was recorded. Visibility was blindly assessed for the amount of air bubbles and the degree of haziness by a single investigator. Five areas of the colon were graded for the amount of air bubbles, from 0 to 3; grade 0 and 1 were defined as the diminishing of air bubbles. The haziness was graded into 5 levels from excellent to unacceptable. Excellent, good and adequate were defined as the diminishing of haziness. The total duration of colonoscopy, the side effect of medication and the endoscopist and patient satisfaction were compared between 2 groups. Endoscopist satisfaction was evaluated by questionnaires. Visual analog scale (0-10) was used for rating patient satisfaction and the side effect of medication.

Eligibility Criteria:
Inclusion Criteria:

- Patients with age 18-70 yrs old who undergo colonoscopy at the endoscopic unit of the hospital

Exclusion Criteria:

* Renal insufficiency (Cr \>2.3 mg/dl)
* Congestive heart failure
* Massive ascites
* Acute myocardial infarction within 6 months
* Coagulopathy
* Previous colonic surgery
* Suspected of colonic obstruction Pregnancy Refuse to give inform consent
Effectiveness of Corneal Accelerated Crosslinking for Infectious Keratitis

The objective of this study is to evaluate the efficacy and safety of accelerated cross-linking (Avedro Inc., Waltham, USA) in the management of microbial keratitis as adjunctive therapy.

Investigators perform a comprehensive ophthalmological examination, including evaluation of risk factors (immunosuppressive status, ocular trauma, previous ocular surgery, contact lens wear, topical corticosteroids use), best-corrected visual acuity (Snellen chart), slit-lamp biomicroscopy, tonometry and fundoscopy. In addition, anterior segment optical coherence tomography imaging (Visante, Carl Zeiss Meditec, Dublin, California, USA), corneal scrapes, culture and clinical photographs at day 1, day 7, month 1 and 3 will be analyzed.

Each participant will be assigned to one of four groups after randomization. Group 1: Initial ulcer on treatment with antibiotic plus sham (n = 66), these partcipants will receive only topical moxifloxacin 0,5% (Vigamoxi, Alcon, Texas, USA) and sham CXL; Group 2: Initial ulcer on treatment with antibiotic plus cross-linking (CXL) (n = 66) receive moxifloxacin plus CXL (riboflavin 0.1% during 10 minutes and irradiation 30 mW/cm2 during 3 minutes using accelerated CXL); Group 3: Refractory corneal ulcer on treatment with antibiotic plus sham (n=66), receive only topical antibiotic plus sham CXL; Group 4: Refractory corneal ulcer on treatment with antibiotic plus CXL will receive their standard medications plus CXL.

Statistical analysis will be divided into four phases: 1) Analysis of compliance, 2) Intention to treat, 3) Losses to follow-up and 4) Variable-response (healing) using Stata/MP 12.0 (Stata Corp., College Station, TX).

Eligibility Criteria:
Inclusion Criteria:

* Subjects with infectious keratitis (initial or refractory to treatment) including bacterial or mycotic keratitis with size larger than 3 mm

Exclusion Criteria:

* herpetic keratitis
* Acanthamoeba keratitis
* pregnancy
* endophthalmitis
* systemic immunosuppression
Internet-based Acceptance and Commitment Training for Elite Ice Hockey Players

The aim of this study is to investigate whether an internet-based psychological training program will enhance performance and affect mental health related factors in elite ice hockey players. The psychological training program is based on Acceptance and Commitment Therapy (ACT), a modern form of Cognitive Behavior Therapy, and is delivered over the internet (hence called "I-ACT"). Elite players in Sweden will be invited before the 2019/2020 season. I-ACT will start for enrolled participants during the first week of October 2019 (30th September- 2nd October depending on the schedule of the particular league; approximately 5 games have then been played in the leagues eligible for participation). I-ACT consists of seven weekly modules/chapters with ACT content and participants also have a psychological trainer in the program that they can contact via a chat function on the web platform. Participants will have completed I-ACT the 17th of November 2019. When I-ACT starts in October, other eligible players will have the opportunity to leave their notice of interest for participation in the study and to take part of I-ACT in a later stage of the season. This concurrent "waiting list" is not a waiting list control group in any sense. It only gives further eligible players the opportunity to enroll in the study for a consecutive start of the psychological training program. I-ACT will start for this second group of players during the last week in november (25th November 2019), and finish I-ACT the 12th January 2020. These two consecutive groups of I-ACT participants will be considered the experimental group. However, due to the length of the ice hockey season the second group will only have follow-up measurements at 1 month for female players (the women's league ends in February 2020) and 2 months for male players (the men's leagues ends in March 2020). Official statistics will be collected from the leagues and enrolled participants will be compared to non-participant players in the leagues to compare the effectiveness of I-ACT on ice hockey performance. Only within-group comparisons will be made for secondary outcome measures.


Eligibility Criteria:
Inclusion Criteria:

* Playing ice hockey on elite level in any of the following leagues: Svenska damhockeyligan (SDHL, the Swedish premier ice hockey league for women), Svenska hockeyligan (SHL, the Swedish premier ice hockey league for men), Hockeyallsvenskan (the Swedish second highest league in ice hockey for men).

Exclusion Criteria:

* Players currently participating in any other individual psychological training program.
Greater Occipital and Supraorbital Nerve Blockade in Migraine Patients

The investigators aimed to evaluate the efficacy of greater occipital nerve and supraorbital nerve blockade with local anesthetics for the preventive treatment of migraine without aura.

A mixture of 1 ml 2% lidocaine and 0.9% 1 ml saline was injected bilaterally to GON and SON in the blockade patients. Placebo patients received 2 ml 0.9% saline in the same way. Patients were blinded to kind of injection.

Eligibility Criteria:
Inclusion Criteria:

* Lack of benefits 1 year from preventive treatment or intolerance to their treatments.
* 18 ≥ years old
* Migraine without aura for more than 1 year, minimum of two or more migraine attacks per month.

Exclusion Criteria:

* Patients with any chronic illness, medication overuse headache, a history of cranial and cervical surgery
* Allergies to local anesthetics
* Hemorrhagic diathesis
* Alcohol or drug abuse
Safety, Tolerability and Pharmacokinetics of Single Rising Inhaled Doses of BI 11054 CL Administered With the Respimat® in Healthy Male Volunteers

To investigate safety, tolerability, and pharmacokinetics of BI 11054


Eligibility Criteria:
Inclusion Criteria:

* Healthy male based upon a complete medical history, including the physical examination, regarding vital signs (BP, PR), 12-lead ECG measurement, and clinical laboratory tests. There is no finding deviating from normal and of clinical relevance. There is no evidence of a clinically relevant concomitant disease.
* Age ≥21 and ≤50 years
* Body mass index (BMI) ≥18.5 and \<30 kg/m2
* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

Exclusion Criteria:

* Any finding of the medical examination (including BP, PR, and ECG measurements) deviating from normal and of clinical relevance
* Evidence of a clinically relevant concomitant disease
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of relevant allergy/hypersensitivity (including allergy to the drug or its excipients) as judged clinically relevant by the investigator
* Intake of drugs with a long half-life (\>24 hours) within at least 1 month or less than 10 half-lives of the respective drug prior to randomisation
* Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to randomisation
* Participation in another trial with an investigational drug within 2 months prior to randomisation
* Smoker (\>10 cigarettes or \>3 cigars or \>3 pipes/day)
* Inability to refrain from smoking on trial days as judged by the investigator
* Alcohol abuse (more than 40 g alcohol a day)
* Drug abuse
* Blood donation (more than 100 mL blood within 4 weeks prior to randomisation or during the trial)
* Excessive physical activities within 1 week prior to randomisation or during the trial
* Any laboratory value outside the reference range that is of clinical relevance
* Inability to comply with dietary regimen of the study centre

The following exclusion criteria are specific for this study due to the known class side effect profile of ß2-mimetics:

* Asthma or history of pulmonary hyperreactivity
* Hyperthyrosis
* Allergic rhinitis in need of treatment
* Clinically relevant cardiac arrhythmia
* Paroxysmal tachycardia (\>100 beats per minute)
Use of NAVA-catheter Positioning Screen to Identify Different Cardiac Arrhythmias

The purpose of this study is to validate a novel method of diagnosing arrhythmias using the NAVA catheter-positioning screen in patients who have a NAVA catheter in place.

The population will be a convenience sample of adults with various arrhythmias who are scheduled to undergo an electrophysiology study and-or ablation (EPSA) under general anesthesia (GETA) at The Toledo Hospital.

After the patient has been successfully intubated at the beginning of the procedure, a trained nurse, using standard technique for placement of a oro/nasogastric tube, will place an appropriately sized NAVA catheter in the patient. The lumen of the NAVA tube can be used as a conventional oro/nasogastric tube and the electrodes will be connected to the Servo-I ventilator. Although the Servo-I is a ventilator, it will be used only as a monitor for this study. The position of the nasogastric tube will then be refined using the catheter positioning screen as needed.

During the course of the EPSA various arrhythmias may become evident. When these are noted, screen shots will be saved on the Servo-i monitor. Surface and electrogram recordings will be saved at the same time. The NAVA catheter will be disconnected from the Servo-I monitor during the ablation part of the procedure to prevent inadvertent damage to the monitor.

Eligibility Criteria:
Inclusion Criteria:

* Cardiac arrhythmia

Exclusion Criteria:

* Pregnancy
Efficacy of Oral AB1010 in Adult Patients With Active Rheumatoid Arthritis

The objective of this study is to evaluate the activity of 2 oral doses of AB1010 in subjects suffering from active RA who have shown an inadequate response to one DMARD including MTX or anti-TNF, after 3 months (12 weeks) of treatment.

The safety and efficacy will be evaluated on:

Rate of patients achieving ACR 20, 50, 70 and 90 DAS (disease activity score) after 3 months treatment ACRn after 3 months treatment Therapeutic maintenance of AB1010 at 3 months Quality of Life assessed by SF12 Health Assessment Questionnaire (HAQ) Clinical and biological safety Pharmacokinetic profile of AB1010


Eligibility Criteria:
Inclusion Criteria:

1. Meet American College of Rheumatology (ACR) criteria for RA
2. Have active RA
3. ACR functional class I-III
4. Disease onset at \> 16 years of age
5. Disease duration of at least 6 months
6. Failure to one DMARD including methotrexate and anti-TNF alpha

Exclusion Criteria:

1. Pregnant or breastfeeding women
2. Inadequate bone marrow function
3. Current use of a DMARD within 4 weeks (or 5 half-lives, whichever is longer) of screening except for leflunomide which requires a specific wash-out
4. Any previous use of recombinant IL1-Ra
5. Current use of more than 1 non steroidal anti-inflammatory drug (NSAID) or change of dose of the NSAID within 4 weeks of baseline or NSAID use greater than the maximum recommended dose
6. Within 4 weeks before baseline, use of more than 10 mg/day of prednisone or equivalent or change in the dose of prednisone or equivalent, or having intra-articular corticosteroid injection or bolus intramuscular or intravenous treatment with corticosteroids (\>20 mg prednisone or equivalent
Evaluation of the Patient Experience With a Surgically-assisted Acceleration Method of Orthodontic Treatment

The duration of orthodontic treatment is one of the exacerbation causes of orthodontic pain. Several methods have been suggested to reduce the duration of orthodontic treatment classified to surgical and non-surgical methods.

Researches used minimally invasive surgical methods like corticision, piezocesion, disicion, micro-osteoperforation, and piezopuncture indicated that most of these methods can accelerate dental movement by 20 - 40% without causing additional pain as a result of using those methods.

Applying corticision on the lower anterior teeth using a surgical blade and a hammer may accelerate tooth alignment during orthodontic treatment. This study consists of two groups, patients will be randomly assigned to one of these two groups.

Pain is defined as an unpleasant emotional sensory experience associated with actual or potential harm. It was mentioned as one of the most common complaints related to orthodontic treatment, and around 65-95% of patients undergoing orthodontic treatment suffer from various degrees of pain.

Corticision is one of the minimally invasive surgical procedures that is not associated with flap lifting. It was used to accelerate tooth movement in animals and case report studies. Its application on humans may aggravate their fear and anxiety towards the pain that may accompany this technique.

No study in the literature has been searched in patient perception of pain, discomfort, levels of acceptance and satisfaction accompanied corticision application application, but in this study, these previous variables accompanied corticision technique have been studied on crowded lower anterior teeth cases which are one of the most common types of malocclusions.

Eligibility Criteria:
Inclusion Criteria:

1. Age range between 18 and 24 years
2. Completion of permanent dentition (except third molars)
3. Mild to moderate crowding (2-6 mm according to Little's index)
4. Absence of medications intake that interferes with pain perception for at least one week before the beginning of the treatment

Exclusion Criteria:

1. Systematic diseases that could affect bone and tooth movement and no contraindication avoid oral surgery
2. Medical conditions that affect tooth movement (Corticosteroid, NSAIDs)
3. Patients had previous orthodontic treatments
4. Poor oral hygiene or concurrent periodontal disease
Safety and Tolerability of GX-I7 in HPV-infected Female Volunteers

This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety and tolerability of GX-I7 in HPV-infected female volunteers

The subjects who are adequately eligible to attend this clinical trial via screening will be assigned to four cohorts (five if necessary) and administered a single dose of GX-I7 solution or placebo drug for intravaginal injection at the visit 3 (Day0) and 7 (Day28). After completing scheduled tests at the visit 6 (Day 14), safety-related data of each cohort will be evaluated by Independent Safety Monitoring Committee (SMC). Dose escalation will proceed under the principal investigator, medical monitor, and the sponsor's mutual approval, referring to SMC's evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Subject willing and able to give informed consent
* Must be ≥19 and ≤45 years diagnosed with HPV infection in two tests within screening periods or have history of HPV infection within 6 months and diagnosed with HPV infection in one test within screening periods
* No clinical abnormality from ECG test
* Must agree to use appropriate contraceptive methods (ie, condoms, cervical cap in conjunction with spermicide, sterilization, and intra uterine device) during the study and for 3 months after the last dose of study drug.

Exclusion Criteria:

* Subject with HSIL or more severe HPV infection
* History of a known or suspected hypersensitivity, shock, or past history to the investigational drug or to similar drugs
* Malignant tumor within 5 years other than successfully treated skin cancer that is not melanoma
* Active infection or history of infection that required intravenous injection of antibiotics 4 weeks prior to the first administration of the investigational drug
* Female subject unwilling to stop breastfeeding or pregnancy
* Positive result from serology examination for human immunodeficiency virus (HIV)
* Major surgery within 3 months other than access surgery
* Mental disorder or other central nervous system disorder determined that the study evaluation cannot be conducted
* Participation in any clinical study within 30 days
* History of alcohol or drug abuse within 6 months prior to the screening
* Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study
Real Time Vital Sign Assessment to Predict Neurological Decline After Traumatic Brain Injury

This study will look to validate predictive algorithms developed in a previous study where we collected relevant data from trauma registry and after using advanced signal-processing and machine-learning, determined prediction scores regarding neuroworsening and other outcomes following traumatic brain injury.


Eligibility Criteria:
Inclusion Criteria:

* Arrival to the hospital within 6 hours of injury
* Age \>= 18 years old
* Patients with traumatic brain injury(TBI). TBI is defined as any alteration or loss of consciousness with or without positive head C.T findings.

Exclusion Criteria:

* Deemed to have a non-survivable TBI
* Brain dead on arrival
* Active substance abuse for opiates and cocaine as noted by admission toxicology screen.
* Any thoracic or abdominal injury resulting in open surgical intervention
* Pregnancy
* Prisoners
* Active military
* Non - English speaking (due to necessity for consent in aims 2 and 3)
* Age \> 89 years
Effect of Vitamin B12 on the Development of Sepsis, in Culture Positive Patients

This is an prospective observational study assessing the effect of vitamin B12 on the odds of developing sepsis in patients with infection confirmed by a positive culture result.

The hypothesis is that patients with infection confirmed by positive cultures who develop sepsis have lower vitamin B12 levels than patients infection, confirmed by positive cultures, who do not develop sepsis.


Eligibility Criteria:
Inclusion Criteria:

* Adults (≥18 years old)
* Infection, confirmed by a positive culture result
* Signed informed consent.

Exclusion Criteria:

* Pregnancy and/or breast feeding
* Inability to follow the procedures of the study, due to language problems, psychological disorders, social conditions or dementia
3D Animation and Models to Aid Management of Fetal CDH

We wish to use the images a mother would have done as part of her normal medical care and make both 3D animations and 3D models of the baby and it's CDH. This will both help the parents see what the problem is and also allow the surgeons, who will operate on the baby once it has been born, to see the size of the hole and what organs are in the wrong place.


Eligibility Criteria:
Inclusion Criteria:

* Target Population: pregnancy women attending Jessop Wing Fetal medicine unit.
* Accessible population: Pregnant women attending Jessop Wing Fetal medicine unit. Whose fetus had a CDH and are referred to MRI.
* Study population: Pregnant women attending Jessop Wing Fetal medicine unit. Whose fetus had a CDH and are referred to MRI and agree to take part in the study.

Exclusion Criteria:

* Not able to give informed consent due to any reason including poor understanding of English
* Under 18 years of age.
* Unable to complete the fetal MRI process due to either metal implants or claustrophobia.