cyrilzakka/clinical-trials huggingface dataset:
Functional and Neurochemical Brain Changes Bipolar Depression

The purpose of the research is to study brain structure, function and chemistry of patients with bipolar disorder who are receiving quetiapine or lithium, in order to better understand who benefits from treatment and why they respond to medications.


Eligibility Criteria:
Inclusion Criteria - Depressed bipolar patients (N=100; 15-20 patients/year):

1. Patients will meet DSM-IV criteria for type I bipolar disorder, depressed, as determined by structured interview and best-estimate diagnostic procedures.138
2. Patient has experienced a maximum of three documented affective episodes.
3. Patient has been off medications for one week prior to study enrollment.
4. Patient has a Hamilton Depression Rating Scale (HDRS) total score ≥20
5. Patient is between the ages of 12 and 35 years.

Exclusion criteria: All subjects will be excluded from participation for the following reasons:

1. Any chemical use disorder within 3 months.
2. Any history of significant suicidality that would place the patient at risk to participate in this protocol.
3. Current score ≥3 on item 3 of the HDRS-17 (Suicide Item)
4. Any medical or neurological disorder that could influence fMRI results.
5. A history of mental retardation or an estimated IQ total score \<85.
6. An MRI scan is contraindicated in the subject for any reason.
7. The patient lives \>100 miles from the University of Cincinnati or cannot attend follow-up visits.
8. Meets DSM-IV criteria for a bipolar mixed episode
Effect of Exercise Among Turtle Neck Syndrome in Pakistani Patients

Turtle neck also known as Text neck or anterior head syndrome is an overuse syndrome which occurs due to repetitive stress to neck, either by hanging it down or forward using phone or electronic devices. Typical signs and symptoms include pain and stiffness in the neck, shoulder pain and increase curvature of spine. It is becoming a global burden as people of almost all ages are getting affected.

The objective of the study is to find out theEffect of Exercise among Turtle Neck Syndrome in Pakistani Population. A total of 100 participants will be included in the study having both males and females. The pain pattern will be assessed by Visual Analog Scale and Posture Grid Assessment tool will be used to assess posture before and after the treatment session.

The study will be divided into three main sections or groups. One group will be treated by myofascial release only while other group will be treated by muscle energy technique for the management of turtle neck syndrome. Third group will receive both MFP and MET exercise. People having neck pain and those who will be willing to participate will be included in the study.

The participants will be divided into four groups namely group A, B, C and D. Initially all the participants will be assessed by posture grid assessment tool to check their postural deviations. People meeting the inclusion criteria will be recruited. Group A will receive Muscle Energy Technique (MET) exercise, Group B will receive Myofascial release (MFP) therapy, Group C will receive both MFP and MET and group D will receive conventional treatment. Pre and post Visual analog scale (VAS) will be used to check pain scale and posture grid assessment tool to check postural angles .Pre-assessment will be done on day one and post at the last day of session. The total duration of treatment will be four weeks.

Consent will be taken from the patients. Only those patients meeting the inclusion criteria and screening questions will included in the study and those who will be willing to participate.

Eligibility Criteria:
Inclusion Criteria:

* both males and females will be included
* patients having non specific neck pain
* usage of mobile more than six hours
* patients willing to participate

Exclusion Criteria:

* pregnant females
* patients having cervical disc bulge or herniation disoriented patients
* patients not willing to participate
* patients having any deformity
The Effect of Sweet Orange Aromatherapy on Anxiety and Pulse Level of Nurse Students

This randomized controlled study examined the effect of sweet orange essential oil aromatherapy on reducing anxiety experienced by nursing students during the IV cannulation process. First-year nursing students from a university in eastern Turkey participated in the study. According to the sample size determined by G\*Power analysis, 100 students were randomized, and the study was completed with 47 students in the experimental group and 48 students in the control group.

All students were taught IV cannulation skills theoretically and practically. Subsequently, students in the experimental group performed IV cannulation on real patients after receiving aromatherapy. Data were collected using a Personal Information Form, a Pulse Monitoring Form, and the State-Trait Anxiety Inventory (STAI).

This randomized controlled trial aimed to evaluate the effectiveness of sweet orange essential oil aromatherapy in reducing anxiety among nursing students during the IV cannulation procedure. The study was conducted with first-year nursing students enrolled in the nursing department of a university in eastern Turkey. The sample size was determined using G\*Power analysis, and a total of 100 students were randomized into two groups. The study was completed with 47 students in the experimental group and 48 students in the control group.

All participants received standardized theoretical and practical training on IV cannulation. Following the training, students in the experimental group were exposed to sweet orange essential oil aromatherapy before performing IV cannulation on real patients, while those in the control group proceeded with the procedure without aromatherapy intervention.

Data collection tools included a Personal Information Form, a Pulse Monitoring Form to track physiological responses, and the State-Trait Anxiety Inventory (STAI) to assess anxiety levels. The study aimed to determine whether aromatherapy could serve as an effective non-pharmacological strategy for alleviating procedural anxiety among nursing students.

Eligibility Criteria:
Inclusion Criteria:

* Being actively enrolled in school, not having performed an IV cannulation before, taking the Basic Principles and Fundamentals in Nursing I course, and not having any health issues that would prevent inhaling sweet orange oil.

Exclusion Criteria:

* Not volunteering to participate in the study, not being actively enrolled in school, and having any health issues that would prevent inhaling sweet orange oil.
The Effects of Sacroiliac Joint Dysfunction on Gait and Disability

It has been reported that gait coordination changes in patients with chronic low back pain, walking slower, taking shorter steps and having asymmetrical stride lengths compared to their healthy peers. In addition to many factor cause gait dysfunction, sacroiliac joint dysfunction might be one of reason of these problems. A study examining the effects of sacroiliac joint dysfunction on gait and disability in individuals with chronic low back pain has not been found in the literature. Therefore, the aim of this study is to evaluate the gait parameters and disability of individuals with chronic low back pain and to reveal their relationship with sacroiliac joint dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* Volunteered to participate in the study.
* Patients with 18-65 years
* Low back pain for at least 3 months,
* Reported pain severity of 2 or greater according to the numeric pain rating scale

Exclusion Criteria:

* Previous spine or lower extremity surgery
* Pregnancy
* Severe hypermobility syndromes
* Severe osteoporosis
* Spondyloarthropathies
* Spondylolisthesis
* Systemic inflammatory diseases
* Any neurological disorder that affects balance and gait
Treatment of Type 2 Diabetes With Immunonutrients

The purpose of this research study is to determine if the nutrients arginine and fish oil will reverse or improve diabetes and to find out what additional good or bad effects a combination of arginine and fish oil may have. Both arginine and fish oil are common nutrients taken by normal people on a frequent basis. However, they have not been used in combination in the proposed doses to reverse diabetes once it is established. This study has been approved by the Food and Drug Administration (FDA investigational new drug \[IND\] 12191).

The hypothesis for the proposed studies is that selected immunonutrients will reduce glucose levels in type 2 diabetes and provide the basis for safe and effective treatment. This should result in an increased resistance to infection, decrease in cardiovascular disease and improve mortality as will be shown in subsequent studies.

Specific Aim 1: To demonstrate proof of concept that supplementation of a normal (diabetic) diet with oral arginine and fish oil will reverse or at least improve glucose control, and improve hemoglobin A1c (HgA1c) in patients with type 2 diabetes.

Specific Aim 2: To determine the relationship of plasma amino acid profiles and concentration of selected fatty acids in cellular (RBC) membranes to the resolution of type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Adult onset diabetics, BMI under 35 with stable glycemic and hypertensive control. Must be receiving medication for diabetes, be free of cardiac problems such as myocardial infarction, atrial fibrillation or flutter, severe hepatic or gastrointestinal disease, and have a glomerular filtration rate (GFR) of greater than 50 ml/minute. Must have an LDL-C of less than 120 mg/ml with or without treatment.

Exclusion Criteria:

* Chronic infection, past history of cancer except cured skin cancer. Active inflammation processes will also be excluded. Pregnant or nursing women will be excluded.
Ketamine Infusion as Sedative Analgesic in Severe ARDS

To evaluate whether ketamine is a safe sedative-analgesic agent to be used in an intensive care unit (ICU) setting as compared to traditionally used agents such as propofol, opioids, and midazolam

According to the 2018 Clinical Practice Guidelines for the prevention and management of pain, agitation/sedation, delirium, immobility, and sleep disruption in adult patients in the intensive care unit (ICU), nonbenzodiazepine sedatives (such as propofol and dexmedetomidine) are preferable to benzodiazepine sedatives (such as midazolam and lorazepam) in critically ill, mechanically ventilated patients. Moreover, continuous use of benzodiazepine (more than 48 hours) has been associated with a risk of prolonged sedation and delirium. On the other hand, though propofol has a remarkable safety profile, it carries unfavorable side effects such as dose-dependent hypotension, hypertriglyceridemia, pancreatitis, and propofol syndrome (which is a rare but potentially fatal complication, associated with high-dose propofol infusions, and characterized by severe metabolic acidosis and circulatory collapse).

During the coronavirus disease 2019 (COVID-19) pandemic, an enormous number of patients required mechanical ventilation, which led to the shortage of traditional sedatives such as propofol, dexmedetomidine, midazolam, and lorazepam in the hospitals. In this challenging time, ketamine was used as an alternative sedative infusion. This study is to evaluate whether ketamine is safer compared to other sedatives in severe COVID related ARDS patients.

Eligibility Criteria:
Inclusion Criteria:

* moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19 with an arterial partial pressure of oxygen divided by the inspired oxygen concentration (P/F) ratio \< 150 with a minimum 5 cm of positive end-expiratory pressure on a mechanical ventilator

Exclusion Criteria:

* post-cardiac arrest status,
* premorbid diagnosis of dementia,
* dependency on extra-corporeal therapies prior to or during ICU stay
Hemicraniectomy in Patients With Malign Middle Cerebral Artery Infarction

This trial is a prospective, randomized, controlled, clinical trial based on a stroke center. We randomly assigned 151 patients 41 years of age or older (median, 65 years; range, 41 to 83) with malignant middle cerebral artery infarction to either conservative medical treatment or hemicraniectomy; assignments were made within 12 to 38 hours after the onset of symptoms. The primary end point was survival with slight or moderate disability 12 months after randomization (defined by a score of 0 to 3 on the modified Rankin scale, which ranges from 0 \[no symptoms\] to 6 \[death\]). Secondary outcome included death, Barthel Index, National Institute of Health Stroke Scale, and Stroke Impact Scale 2.0 (SIS) 6 months and 1 year after randomization. Variables for subgroup analyses were age, sex, presence of aphasia or neglect, stroke severity and time to randomization. The study was performed according to Consolidated Standards of Reporting Trials (CONSORT).

Patients between 40 to 80 years of age were included within 12 to 38 hours of a malignant middle cerebral artery infarction defined by the association of 3 criteria: a National Institutes of Health Stroke Scale score ≥16, including a score ≥1 for item 1a (level of consciousness); brain computed tomography ischemic signs involving 2/3 of the middle cerebral artery territory; and a diffusion-weighted imaging (DWI) infarct volume \>150cm3. The first patient was enrolled in January 2003 and the last patient in December 2007. An independent data safety monitoring committee monitored the safety, progress, and ethics of the trial. Patients were randomized to either surgical plus medical treatment or to conservative medical treatment alone.

Eligibility Criteria:
Inclusion Criteria:

* A National Institutes of Health Stroke Scale score ≥16
* A score ≥1 for item 1a (level of consciousness)
* Brain computed tomography ischemic signs involving 2/3 of the middle cerebral artery territory
* Diffusion-weighted imaging infarct volume \>150cm3

Exclusion Criteria:

* Prestroke modified Rankin score score ≥2
* Prestroke score on the Barthel Index \<95
* Score on the Glasgow Coma Scale \<6
* Both pupils fixed and dilated
* Any other coincidental brain lesion that might affect outcome
* Plasminogen activator in the 12 h before randomisation
* Space-occupying hemorrhagic transformation of the infarct
* Pregnancy
* Life expectancy \<3 years
* Other serious illness that might affect outcome
* Known coagulopathy or systemic bleeding disorder
* Contraindication for anesthesia
Effect of Folic Acid on Primary Folate Forms in Relation to MTHFR

The common polymorphism in MTHFR gene (C677T) has a significant effect on (6S)-5-CH3-H4folate after folic acid supplementation. For example, post supplementation differences in (6S)-5-CH3-H4folate between CC and TT are above 30%.

The investigators aim to test the effect of low doses of folic acid with or without B6 and B12 on folate forms in relation to polymorphisms in folate catabolising enzymes in elderly people. Our hypothesis is that differences in folate forms after folic acid supplementation might be due to polymorphisms in folate catabolising enzymes. Therefore, folic acid might be retained by people with certain genotypes.

Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Age \> 65 years.

Exclusion Criteria:

* Renal dysfunction
* Recent stroke, or coronary event (within the last 3 months)
* Current cancer treatment
* Antifolate (e.g. methotrexate) treatment
* Ileum resection
* Current B-vitamin supplement
* Epilepsy medications
* Megaloblastic anemia or other indications for treatment with high doses of folate or vitamin B12.
Expression of Th9 Cells and Poor/Non-responsiveness to Hepatitis B Vaccination

An observational study will be performed in subjects aged 3-65 years old to describe the dynamic changes of cellular immunity after vaccination of hepatitis B vaccine, and to find out the expression levels of Th9 cells and IL9 in subjects with different response to the primary immunization (3 single -dose injunctions).

This study selected 74 volunteers which had the hepatitis B vaccine (immunization programs 0,1,6) , anti-HBs≤10mIU as the research subjects, and choose 20 volunteers which anti-HBs≥1000mIU as the control group, revaccination the groups according to the normal immunization programs, then the blood samples would be collected at 7th day, separate the PBMC and detect the expression levels of Th9 cells and IL9 by FCM, trying to find out the effects of Th9 and IL9 of non/poor -responsiveness subjects to hepatitis B.

Eligibility Criteria:
Inclusion Criteria:

* volunteer
* between 3-60 years old
* healthy
* have the history of vaccination of hepatitis B.
* Recent serological testing result show HBsAg, HBeAg, anti-HBe, anti-HBc, HBV DNA and Pre-S1 should be negative.
* informed consent
* not allergic to the component of the vaccine

Exclusion Criteria:
Paper-based Electrochemical Point-of-care Device in Diagnostic of Orthopedic Infections

Periprosthetic Joint infections (PJI) and spondylodiscitis are considered some of the most costly infectious diseases because require at least one surgery, prolonged hospitalisation, rehabilitation care, prolonged antibiotherapy, and extended absence from work in working-age patients. Ortho-PoC will face this issue with a smart and highly innovative diagnostic tool, starting from the point-of-care device for infection diagnosis in the orthopedic field developed and published by the coordinator Fondazione Policlinico Universitario Agostino Gemelli IRCCS and one partner Università degli Studi di Roma Tor Vergata. Ortho-PoC will further go beyond the state of the art by delivering a point-of-care device based on multiparametric analysis, in easily collected synovial fluids or pus. Several samples will be analysed using Ortho-PoC at three different Hospitals (Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Ospedali Riuniti di Foggia, Azienza Ospedaliera Universitaria Policlinico Vanvitelli Napoli) and the data will be treated with artificial intelligence (AI) to deliver an AI-assisted robust, effective, and smart diagnostic device for PJI.


Eligibility Criteria:
Inclusion Criteria:

* patients that received a joint implant or spine surgery, clear signs of infection (according to international guidelines)
* patients off antibiotic therapy at least for two weeks
* Sample biopsy of minimum 1 ml.

Exclusion Criteria:

* pregnant women,
* patient affected by cancer
* patient under antibiotic therapy
Efficacy and Safety Study of Sr-hGH in Comparison With Daily hGH in ISS Patients

The purpose of this study is to assess dosing requirements and establish the efficacy of SR-hGH in idiopathic short stature patients (ISS). This phase II study is designed as multi-center, randomized, active comparator-controlled, parallel, open-label.

45 patients were randomized to three arms with 1:1:1 ratio, two arms of Sr-hGH and one of daily hGH. Two doses of Sr-hGH were administered, which are 0.5 and 0.7mg/kg/week. And the other arm received daily hGH at 0.37 mg/kg/week.

Patients in Sr-hGH groups injected on a specific day of the every week for 26 weeks. And patients randomized to daily hGH group injected for 6 days a week.

Patients visited study centers five times, firstly at screening (Visit 1), at randomization (Visit 2), after 13th dosing (Visit 3), after 26th dosing (Visit 4), and finally for follow-up (Visit5).


Eligibility Criteria:
Criteria

* are older than or equal to age of 4
* are pre-pubertal (Tanner's stage I)
* are younger than bone age of 9 in female; of 11 in male
* have less than 3 years of a difference in bone and chronological age
* have confirmed idiopathic short stature
Cataract Online Refraction Evaluation: A Multi Center Randomized Controlled Trial

Background of the study:

Cataract is widely prevalent in especially elderly and cataract extraction surgery has thus become one of the most performedsurgeries worldwide. In recent decades the safety of cataract surgery has greatly improved and it is considered one of the safestsurgeries to be performed. Postoperative management consists of routine examinations within one week, to ascertain no adverseevents have occurred immediately after surgery, and between 4-6 weeks, to determine the refractive error. The incidence of seriousadverse events following cataract surgery is estimated to be 1%. As a result, the majority of patient visits after cataract surgery willbe uneventful. Nonetheless valuable time and hospital resources are consumed. Remote monitoring could replace clinicalexaminations in selected patient groups. However, this practice of digital remote monitoring which the patient can use independentlyhas not been clinically validated yet.

Objective of the study:

To determine non-inferiority of the corrected distance visual acuity (CDVA) with the prescription obtained through the web-basedmeasurement of refractive error, compared to usual care, in patients who underwent routine cataract surgery.

Study design:

Observational randomized trial without interventions

Study population:

Patients eligible for cataract surgery, without visual acuity influencing comorbidities or predisposing complicating factors.

Primary study parameters/outcome of the study:

costeffectiveness

Secundary study parameters/outcome of the study (if applicable):

Corrected distance visual acuity at the final post-operative visit, uncorrected distance visual acuity, refractive error(sphere/cylinder/axes), patient reported outcome measurements, adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Planned for bilateral phacoemulsification cataract extraction and intra-ocular lens implantation (either sequentialor in one procedure)
* ≥ 18 years of age
* No other current ophthalmic conditions or history that negatively influence post-operative visual acuity
* Be able to fill out the health questionnaires (in Dutch, German or English) and perform the web-based refractiveassessment (possibly with assistance of family member or other close relative).
* Specific digital requirements include access to a computer and a smartphone and knowledge how to log in to anonline patient portal.

Exclusion Criteria:

* Cataract extraction surgery combined with other procedures, including: keratoplasty, vitrectomy, glaucoma filter implants
* Ocular comorbidities that negatively influence post-operative visual acuity
* No access to the digital requirements to take the online health questionnaire and/or perform the online refraction.
* Insufficient command of the Dutch, German or English language to understand the questionnaires andinstructions of the web-based refractive assessment or no family member / close relative to assist with this
* Inability of performing the web-based eye exam prior to cataract surgery.