cyrilzakka/clinical-trials huggingface dataset:
Virtual Darkness as Additive Treatment in Mania

In this randomized controlled study we will investigate the effect of blue-blocking goggles or screens (virtual darkness therapy) on manic symptoms in bipolar disorder compared to placebo. This 3-armed study includes 2 patient-groups and a non-bipolar control-group. The main hypothesis is that virtual darkness therapy is effective as additive treatment in mania.Other hypotheses are that virtual darkness therapy has significant effects on sleep, motor activity, circadian rhythm and mood also in the non-bipolar control-group.

Recent discoveries in neurophysiology has shown that "virtual darkness" is achievable by blocking blue wavelengths of light (Phelps, 2007). A newly discovered retinal photoreceptor called the Intrinsically photoresponsive retinal ganglion-cell (IpRGC) whose fibers directly synapses with the suprachiasmatic nucleus (SCN), responds only to a narrow band of wavelengths with highest sensitivity between 446 and 484 nm (Brainard et al., 2001; Berson 2007). Amber tinted goggles preserve normal nocturnal melatonin levels in light environments, which means that blocking of the blue wavelengths is perceived as virtual darkness to the SCN (Kayumov, 2005; Sasseville, 2006).

In this randomized controlled study we will investigate the effect of blue-blocking goggles or screens (virtual darkness therapy) on manic symptoms in bipolar disorder compared to placebo. The general feasibility of the method both in research and treatment will be evaluated. This is a multi-site study covering Helse Fonna Local Health Authority's catchment area wich serves a population of 120000 adults. This 3-armed study includes 2 patient-groups and a non-bipolar control-group. The main hypothesis is that virtual darkness therapy is effective as additive treatment in mania.Other hypotheses are that virtual darkness therapy has significant effects on sleep, motor activity, circadian rhythm and mood also in the non-bipolar control-group. The study may contribute to develop a supplement to the current treatment in mania and may also generate new hypotheses about the underlying pathophysiological mechanisms in bipolar disorder.

Eligibility Criteria:
PATIENT GROUPS

Inclusion Criteria:

* Inpatients
* Diagnosis of DSM IV-TR of Bipolar I or Bipolar II disorder with current manic episode as verified by the semistructured interview MINI plus
* Ability to comply with the protocol
* Willingness to participate in the study
* Delayed written informed consent at discharge

Exclusion Criteria:

* Inability to comply with the protocol
* Severe retinal damage, cataract or corneal damage on both eyes
* Daily use of NSAIDS
* Daily use of betablockers
* Daily use of calcium-antagonists

NON-BIPOLAR CONTROLS

Inclusion Criteria:

* Written informed consent

Exclusion Criteria:

* Working night shift
* Diagnosed with bipolar disorder or single manic episode
* Severe retinal damage, cataract or corneal damage on both eyes
* Daily use of alcohol
* Daily use of benzodiazepines
* Daily use of NSAIDS
* Daily use of betablockers
* Daily use of calcium-antagonists
Acute Exercise Type and Cognitive Function: An Event-related Potential Study

This study aims to examine the effects of different types of acute exercise on cognitive functions in healthy adults.

Acute exercise, a single session of exercise, has been shown to enhance cognitive functions. The meta-analysis research has suggested that such benefits might depend upon the types of exercise. However, the predominant types of exercise examined within this area of research are aerobic and resistance exercises. The effects of other types of exercises on cognitive functions are poorly understood. Accordingly, this study is going to examine the effects of different types of acute exercise \[i.e., aerobic exercise (AE), aerobic exercise with virtual reality (AE-VR), and combined exercise (CE)\] on cognitive functions.

140-180 healthy young adults will be recruited and then randomly assigned to the AE, AE-VR, CE, and Control groups for a 35-minute intervention. Cardiovascular fitness will be assessed beforehand. Additionally, Stroop tasks and several questionnaires will be conducted before and after the intervention. The targeted primary outcomes are changes in cognitive behavior performance (assessed by the Stroop tasks) and neuroelectrical indices (e.g., P3 of event-related potential). The secondary outcomes are the changes in exercise enjoyment, motivation, and emotion.

Eligibility Criteria:
Inclusion Criteria:

* no major psychiatric illness or physical disease
* able to do 30-minutes moderate exercise
* normal or corrected-to-normal vision
* right-handed
* moderate exercise ≤ 150 min/week

Exclusion Criteria:

* any neurological, respiratory, vascular, metabolic, or brain-relative disease
* any physical limitation or injury
* any wounds on the scalp
* have experience of using technology products
* regular engagement in exercise training programs
Bleeding in Laparoscopic Liver Surgery

Blood loss during liver resection surgery affects patients morbidity, short and long-term mortality. Among non-surgical interventions to minimize intraoperative blood loss and perioperative blood products transfusion, maintaining conditions of low central venous pressure is considered as standard of care. In animals undergoing laparoscopic hepatectomy, reducing airway pressures represents a minimally invasive measure to reduce central venous pressure and therefore bleeding from the hepatic vein. Neuromuscular blocking agents are usually administered during anesthesia to facilitate endotracheal intubation and to improve surgical conditions: a deep level of neuromuscular blockade has already been shown to reduce peak airway pressures and plateau airway pressures in non-abdominal procedures. Such airway pressures reduction can potentially limit bleeding from hepatic veins during transection phase in liver surgery. The aim of the present study is to evaluate the impact of deep neuromuscular blockade on bleeding (as a consequence of reduced airway peak pressure and plateau pressure) in hepatic laparoscopic resections. Patients undergoing laparoscopic liver resection will be randomized to achieve, using intravenous Rocuronium, either a deep neuromuscular blockade (post-tetanic count = 0 and/or = 1 and train of four count = 0) or moderate neuromuscular blockade (train of four count ≥ 1 and/or post-tetanic count \> 5) during surgery. Neuromuscular blockade measurements will be performed every 15 minutes. The primary endpoint is to assess the total blood loss at the end of the resection phase.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing laparoscopic liver resection
* Patients ≥ 18 years old
* Patients willing to participate to the study and able to validly sign informed consent.

Exclusion Criteria:

* Patients presenting a pre-operative platelet count \< 50 x 109/L and/or patients with active pre-operative bleeding
* Patients with planned requirement of continuous neuromuscular blockade monitoring (upon clinical judgement)
* Known hypersensitivity / previous allergic reactions to study medications
* Planned total intra-venous anesthesia technique
* Pregnant or breastfeeding patients.
Effect of Massage Therapy in Cortisol Level

This study evaluates the effect of a single session of Massage Therapy in salivary cortisol level. All participants were assessed on three conditions: Massage session, rest in supine position listening music, and under normal working conditions. The hypothesis of the investigators is that the effect of the massage action in reduction of cortisol is superior to only rest.

Several studies have postulated that one of the physiological markers of the effect of massage therapy is to reduce the level of cortisol, the "stress hormone". However it is not clear whether the effect is due to the manual action on the skin, or only by the relaxation induced rest. Therefore the variation of salivary cortisol in both conditions, and also in everyday working conditions was compared. Cortisol has a circadian cycle, with a maximum value upon awakening, which decreases during the morning; therefore a sample of saliva (in Salivette tube) it was collected in the three experimental conditions at the same hour time in the morning: 8:45(after intervention), and 9:30 and 10.30 (both, before).

Eligibility Criteria:
Inclusion Criteria:

* Office/administrative workers of Faculty of Medicine, University of Chile.

Exclusion Criteria:

* Musculoskeletal disease or injury in spine.
* Body Mass Index over 35.
* Smoking (over three cigars at day)
* Depression.
* Pregnancy
* Corticosteroid treatment.
* Skin wound or disease.
* Intolerance to the prone position.
Effect of a Spice Blend on Cardiovascular Risk Factors and Diet Satisfaction

This study is a randomized 3-period crossover, controlled feeding study designed to evaluate the effects of the most commonly consumed spices in the U.S. on CVD risk factors, inflammation \& immune function, and diet satisfaction in participants at risk for CVD.

A 3-period randomized crossover controlled-feeding study will be conducted. Participants will be randomly assigned to receive each 4-week treatment (diet) in random order. Each test diet period will be separated by a standard 4-week compliance break. Data collection will be conducted across at baseline (start of study) and the end of each diet period to assess the effects of chronic spice consumption on selected cardiovascular endpoints.

Eligibility Criteria:
Inclusion Criteria:

* overweight or obese (25-35kg/m2)
* non-smoking
* male or female
* waist circumference \>= 94cm for men and \>=80cm for women
* at least one other of the following: LDL- cholesterol \>130mg/dL; CRP \>1mg/L; triglycerides \>=150mg/dL; HDL \<40mg/dL for men or \<50mg/dL for women; systolic blood pressure \>= 130mmHg or diastolic \>= 85mmHg; fasting glucose \>=100mg/dL

Exclusion Criteria:

* diabetes (fasting glucose \>126mg/dL)
* hypertension (systolic blood pressure \>160mmHg or diastolic blood pressure \>100mmHg)
* prescribed anti-hypertensive or glucose lowering drugs
* established cardiovascular disease, stroke, diabetes, liver, kidney or autoimmune disease
* use of cholesterol/lipid lowering medication or supplementation (psyllium, fish oil, soy lecithin, phytoestrogens) and botanicals
* pregnancy or lactation
* weight loss of \>=10% of body weight within the 6 months prior to enrolling in the study
* vegetarianism
Comparison of Subcostal and Transhepatic Views to Assess Inferior Vena Cava by Echocardiography

Comparison of subcostal and transhepatic views to measure inferior vena cava diameter by echocardiography in intensive care unit patients


Eligibility Criteria:
Inclusion Criteria:

* patient hospitalised in ICU

Exclusion Criteria:

* gardianship
* contraindication to transthoracic echocardiography
Dipole Density Mapping of Typical Atrial Flutter

Study to determine the feasibility of the Acutus Medical System in obtaining data to create Dipole Density Maps of electrical activation in the right atrium in patients with typical atrial flutter.


Eligibility Criteria:
Inclusion Criteria:

1. Be aged 18 to 75 years
2. Be scheduled for ablation of typical atrial flutter (cavotricuspid isthmus dependent)
3. Be able and willing to give informed consent

Exclusion Criteria:

1. Have any of the following:

   1.1 Patients with implanted prosthetic, artificial, or repaired cardiac valves in the chamber being mapped.

   1.2 Patients with permanent pacemaker or ICD leads in the chamber being mapped. 1.3Patients with hypercoagulopathy or an inability to tolerate anticoagulation therapy during an electrophysiology procedure.
2. Require treatment in the left atrium and/or a require a transseptal puncture to access the left atrium during the index procedure
3. Have had a myocardial infarction within the prior two months
4. Have had cardiac surgery within the prior three months
5. Have an intracardiac thrombus
6. Have clinically significant tricuspid valve regurgitation or stenosis
7. Have had any cerebral ischemic event (including transient ischemic attacks) in the prior six months
8. Be pregnant or nursing
9. Be currently enrolled in any other clinical investigation
Point of Care Ultrasound for Diagnosis of Abdominal Free Air

This study evaluates the ability of ultrasound to identify intraperitoneal free air. The study will consist of blinded review of abdominal ultrasound images of patients before and after laparoscopic surgery, a procedure which results in the introduction of air into the peritoneal cavity.

Free peritoneal air is a marker of potential intraabdominal catastrophe, reflecting perforation of a hollow viscous organ such as stomach or intestine. While definitively identified by computed tomography, this diagnostic test can be delayed. Presence of air beneath the diaphragm on an upright chest or abdominal radiograph can allow for faster diagnosis, but again can present limitations in terms of timing.

Bedside clinician performed ultrasound has become standard practice in emergency medicine and critical care settings. Traditionally, air is not conducive to diagnostic ultrasound, but the artifacts it creates can be used to give clues about certain conditions. Recently this artifact has been proposed as a means to identify free peritoneal air. Several small studies have shown promise for the technique, but further investigation is warranted.

In this study the investigators will generate a database of standardized abdominal ultrasound images in subjects undergoing laparoscopic surgery. During this surgery, the peritoneal cavity is intentionally insufflated with air. The majority of this is removed at the end of the case, but small volumes of air remain, as evidence by the presence of air on CT scan when performed shortly after surgery.

The investigators will obtain a standardized set of images preoperatively and post operatively which will then be reviewed in a blinded fashion by three expert reviewers, one each from radiology, surgery and emergency medicine, with data analysis to determine sensitivity and specificity of ultrasound for free air.

Eligibility Criteria:
Inclusion Criteria:

* Subjects scheduled for elective laparoscopic surgery
* Age 18 or greater

Exclusion Criteria:

* Age less than 18
* Pregnant
* unable to provide consent
Optimal Lidocaine Buffering to Reduce Injection Pain in Local Anesthesia

The purpose of this study is to determine the optimal amount of lidocaine buffering needed to decrease injection pain when administering local anesthesia.

Once the site is chosen, the skin will be anesthetized as usual. This study will utilize a commercially prepared 1% lidocaine solution mixed with standard sodium bicarbonate. A total of 10 mL will be used.

Eligibility Criteria:
Inclusion Criteria:

* adults presenting for routine thyroid biopsy, paracentesis or thoracentesis in interventional radiology

Exclusion Criteria:

* Patients requiring sedation
* Patients with altered mental status
* Children
* Patients allergic to lidocaine or sodium bicarbonate
Assessing Success of MTA and Pre-mixed Bioceramic in Mature Teeth With Irreversible Pulpitis With Full Pulpotomy.

Although many pulpotomy agents are commercially available, there is a dearth of clinical research comparing the efficacy of these agents in treating individuals with irreversible pulpitis. Bioceramic and MTA both have similar clinical uses, but Bioceramic is distinguished from MTA by its superior chemical, physical, and biological properties. This study aims to address this knowledge deficit by assessing the performance of biocompatible materials in pulpotomy procedures for the treatment of symptomatic permanent teeth in adults with deep caries. For permanent teeth with a completed root and a diagnosis of irreversible pulpitis without apical periodontitis, this research will compare the success rates of MTA and EBRRM pulpotomy procedures in order to provide evidence-based clinical practice guidelines for the treatment of this disease.

The goal of this observational study is to test and compare the success of full pulpotomy with Mineral Trioxide Aggregate (MTA) pre-mixed bioceramic in mature teeth with irreversible pulpitis. Participants in this study were patients with irreversible pulpitis without apical periodontal pathosis recruited from the waiting list at the School of Dentistry at Liaquat University of Medical and Health Sciences in Jamshoro. After obtaining informed consent, demographic information, clinical examination results, and binary variables were recorded pre- and intra-operatively. The study's primary aim was to assess postoperative pain, and secondary aims included assessing the presence of swelling, sinusitis, or fistula and detecting tooth mobility. Participants received either MTA or Endo Sequence Bioceramic Root Repair randomly allocated using a lottery system. Follow-up assessments were done initially, after 6 days, and after 6 months, and periapical radiography was done at 6 days and 6 months to detect radiolucency.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with diagnosis of irreversible pulpitis without apical periodontitis
2. Either gender
3. Lower Age 10 Years - Upper Age 40 Years

Exclusion Criteria:

* Teeth displaying indications of resorption.
* Teeth that have not fully developed, characterized by open apices.
* Canals that are calcified or obstructed.
* Perforations that were caused by the dentist.
* Fractures in the root
* Teeth that cannot be restored
* • Teeth that are unable to withstand frigid temperatures, have a sinus infection, or have swelling around them.
* There has been no pulp exposure despite the removal of carious lesion.
* Ten minutes after a pulpotomy, hemorrhage could not be stopped.
* Necrotic or partly necrotic pulp is indicated by insufficient bleeding after exposure.
Naproxen for Pain Control With Intrauterine Device Insertion

The purpose of this study is:

1. To evaluate whether 550 mg of naproxen sodium reduces pain scores with IUD insertion on a 0-10cm visual analogue scale compared to placebo (primary outcome).
2. To evaluate whether 550 mg of naproxen sodium reduces pain scores with tenaculum placement, uterine sounding and post-procedurally on a 0-10 cm visual analog scale compared to placebo (secondary outcomes).
3. To establish if prophylactic naproxen sodium is acceptable for routine use prior to IUD insertion.

Hypothesis: The administration of naproxen sodium, 550mg orally, 1 hour prior to IUD insertion will lead to a reduction in pain scores associated with IUD insertion compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Premenopausal
* Presenting for insertion of any IUD type (i.e. Mirena, Paragard, Skyla)
* English-speaking or non-English speaking with appropriate translator available

Exclusion Criteria:

* Currently pregnant or pregnant within the last 4 weeks
* Not eligible for IUD insertion per PPLM's clinical protocols
* Presenting for IUD removal and reinsertion
* Any diagnosis of chronic pain (including fibromyalgia, endometriosis, dysmenorrhea, irritable bowel syndrome, interstitial cystitis)
* Pain medications taken within 12 hours of enrollment
* Misoprostol usage within 24 hours of enrollment
* Any known allergy or contraindication to non-steroidal anti-inflammatory drugs (including active renal disease, active hepatic disease, gastric ulcer disease or gastritis, and bleeding disorders)
Pharmacokinetics of Epinephrine During Cardiac Arrest

To determine the pharmacokinetics of epinephrine during cardiac arrest.

The aim of out study is to determine the pharmacokinetics in humans during cardiac arrest, following a single dose of epinephrine. Venous samples will be withdrawn every minute the first five minutes following a single dose.

The aim of the study is to determine T1/2 in a clinical setting and to determine time to peak concentration.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-85 yrs
* Witnessed non-traumatic cardiac arrest.
* Probable cardiac origin
* Treated by Bergen Emergency Medical Services

Exclusion Criteria:

* Terminal illness
* Residents of nursery homes
* Obvious dead
* Hypothermic patients
* Epinephrine administered before arrival of study physician
Pulse Oximetry- Evaluating Sensor Off- PCBA-1

To demonstrate that the sensor-off feature on the Pulse oximeter displays per specifications when the sensor is removed from the finger.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects 18 or older (inclusive).
2. Subject is able to participate for the duration of the study
3. Subject is willing to sign an informed consent

Exclusion Criteria:

1. Previous injury or trauma to fingers or hands that may change blood flow or vascular supply and affect our ability to test sensors
2. Physiologic abnormalities that prevent proper application of a medical sensor and electrode
3. Severe contact allergies that cause a reaction to standard adhesive materials such as those found in medical sensors and electrodes
Changes in Bacterial Flora Among Patients With Pelvic Bedsores: a Prospective Pilot Study

The main objective of this study is to characterize the evolution (over a period of 28 days) of superficial and deep bacterial skin flora in patients with stage 3 or 4 sacral pressure ulcers (bedsores). Changes in terms of pathogenic, potentially pathogenic and non-pathogenic bacterial species at the intra-individual and population levels.

The secondary objectives of this study are:

A. To compare bacterial communities collected from superficial versus deep samples of stage 3 or 4 sacral bedsores using metagenomics and standard culturing methods.

B. To characterize the evolution of digestive bacterial flora in the same patients over a period of 28 days. Changes in terms of pathogenic, potentially pathogenic and non-pathogenic will be described, as well as the appearance of resistance phenotypes.

C. To characterize the evolution of urinary bacterial flora in the same patients over a period of 28 days. Changes in terms of pathogenic, potentially pathogenic and non-pathogenic will be described, as well as the appearance of resistance phenotypes.

Eligibility Criteria:
Inclusion Criteria:

* The patient was correctly informed about study implementation, its objectives, constraints and patient rights
* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 28 days of follow-up
* The patient has one or more pelvic pressure ulcers (bedsores)(stage 3 or 4 only). Note: Patients with bedsores of varying stage will be included for the wound corresponding to the highest stage. If the patient has multiple bedsores of the same stage, the deepest wound will be selected.
* The patient requires a modern wound dressings (i.e. not tulle or gauze) without added bactericidal or antibiotic elements
* The patient is hospitalized ant the Propara neurological rehabilitation center (Montpellier, France)
* The patient has not received antibiotics in the last 14 days.

Exclusion Criteria:

* The patient is participating in another study, or has participated in another study in the last 3 months
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant, parturient, or breastfeeding
* The patient is already included in the present study
* The patient has sacral pressure ulcers of only stages 1 or 2, or does not have a sacral pressure ulcer
* Patient under curative anticoagulation
* Patient who received antibiotics within 14 days before inclusion (however, after inclusion, the patient can be treated with antibiotics if necessary)