cyrilzakka/clinical-trials huggingface dataset:
Predicting Antipsychotic Discontinuation in Psychosis

The purpose of this study is to determine whether dopamine synthesis capacity by using \[18 fluorine(F)\]-DOPA PET for patients with schizophrenia in the maintenance phase can predict treatment discontinuation.

There are two groups: the healthy control group (n=12) and the patient group (n=26). The patient group recruits subjects diagnosed with first episode psychosis which occurred within 2 years and having been treated with antipsychotics for 1 year. Participants will complete clinical scales and undergo PET scans. Subjects in the patient group will receive a reduced intake of antipsychotics by 25% after each week of the four-week period in which they will also undergo PET imaging at the baseline, 7 week, and 8 week marks to detect the correlation between the capacity of presynaptic dopamine and relapse in the patients discontinuing treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Patient group

1. Patients who met DSM-IV criteria for schizophrenia, schizoaffective disorder, and schizophreniform disorder
2. patients diagnosed with first episode psychosis which occurred within 2 years and having been treated with antipsychotics for at least 1 year.
3. Patients who have maintained in the stable state for 3 months without medication change at the baseline.

2. Healthy control group

* Healthy controls has no Axis I disorder and do not report any past event of neurological or psychiatric illness assessed by the Structured Clinical Interview for DSM Disorders

Exclusion Criteria:

1. Participants should not have any neurological illness such as head trauma, seizure and meningitis.
2. Participants should not be diagnosed as Mental retardation(IQ\<70)
3. Participants should not have severe personality disorder, substance abuse or dependence (except for nicotine abuse and dependence) and severe medical conditions.
Efficacy and Safety of Continuous Infusion of Ketamine in Pediatric Intensive Care Unit (KISS Study)

This study, prospectively evaluate the efficacy and safety of ketamine administered in continuous infusion lasted more than 12 hours in children admitted to Pediatric Intensive Care Unit of Padova. This drug may be used as adopted as adopted as adjuvant to analgesia and sedation or as adjuvant to bronchospasm therapy. The investigators evaluated efficacy considering the sparing of other analgesics and sedatives and the level of sedation after ketamine infusion for the first use and the sparing of other bronchospasm drugs sedative dosage for the second use. To evaluate safety the investigators considered the presence of adverse effects and onset of withdrawal and delirium syndrome. The study will included al least 55 pediatric patients \< 18 years and mechanically ventilated.

Ketamine is an N-Methyl-d-aspartate-receptor-antagonist commonly used over the last decades as an anesthetic and analgesic agent for procedural sedation. The use of ketamine as a prolonged infusion was first described in 1990 and a prolonged infusion of ketamine has been described as a successful strategy for analgesia and sedation in patients with hemodynamic instability, in patients who were mechanically ventilated and poorly responsive to conventional drugs. An other indication for ketamine infusion is the presence of bronchospasm, due to its action in promoting bronchodilatation. However, existing studies on ketamine for prolonged sedation are mainly retrospective and include small sample size, suggesting that this topic needs to be further investigated. The aim of this observational single center study is to describe the use of ketamine used as adjuvant to conventional analgesic and sedative strategy (opioid and benzodiazepine in continuous infusion) as prolonged infusion (i.e. ≥ 12 hr) in pediatric patients. The investigators will evaluate ketamine indications, dosages, infusion duration, adoption of boluses, modality of weaning. Concomitant analgesic and sedative management and monitoring of level of sedation (using a validated scale) are considered measures of efficacy. Sparing of other bronchospasm drugs sedative dosage are considered measures of efficacy if ketamine is used in patients with obstructive respiratory diseases. Presence of adverse effects (including withdrawal syndrome symptoms and delirium) during infusione or 48 hours after weaning are considered measures of safety. Data were collected using a standardized data sheet. The study lasted 18 months to reach a numerosity of 55 patients. All the requested institutional approvals were collected before starting the data collection.

Eligibility Criteria:
Inclusion Criteria:

* pediatric intensive care unit admission
* mechanical ventilation
* ketamine infusion \> 12 hours

Exclusion Criteria:

* parents refusal to participate
Online Web-Based Deep Relaxation Exercise Applied to Pregnant Women on Maternal Fetal Attachment and Pregnancy Perception

This study was planned as a pre-test post-test randomized controlled study in order to determine the effects of an online web-based deep relaxation exercise applied to pregnant women on maternal-fetal attachment and pregnancy perception. The study is planned to be conducted with pregnant women reached through social media (such as Facebook, Messenger, Instagram). The study is planned to be conducted between December 15, 2024 and June 15, 2025. The universe of the study will consist of pregnant women who volunteer to participate in online deep relaxation exercises and share their contact information. When the power analysis was performed, the sample size was calculated as a total of 80 pregnant women (40 experimental, 40 control), assuming that the web-based deep relaxation exercise applied would increase the mean maternal-fetal attachment score (72.25±7.16) (Güney and Uçar, 2019) by four and a half points at a 5% error level, a two-sided significance level, a 95% confidence interval, and an 80% ability to represent the universe (https://www.stat.ubc.ca/\~rollin/stats/ssize/n2.html). Pregnant women to be included in the groups will be selected from the relevant population using the improbable random sampling method.


Eligibility Criteria:
Inclusion Criteria:

* Women with internet access,
* Women expecting a single baby,
* Women whose pregnancy is 12-24 weeks

Exclusion Criteria:

* Women with a history of physical and/or psychological illness and those taking any psychiatric medication
* Women who answered the survey questions incompletely.
Impact of Periodontal Therapy on AF Recurrence Post-Ablation in High-Inflammatory Burden Patients

Comparison of Non-Surgical Periodontal Therapy versus Background Periodontal Care in Reducing Atrial Fibrillation Recurrence in Patients with AF and Periodontitis: A Randomized Trial with Two Arms (Background Therapy Group vs. Conventional Non-Surgical Therapy Group).


Eligibility Criteria:
Inclusion Criteria:

- Age ≥18 years. Diagnosed with atrial fibrillation (AF) and undergoing first-time catheter ablation.

Diagnosed with periodontitis (2017 World Workshop classification) and periodontal inflamed surface area (PISA) \>500 mm².

Willing and able to provide written informed consent.

Exclusion Criteria:

- Requiring periodontal surgical intervention, e.g., flap surgery, bone grafting. Non-surgical periodontal therapy (e.g., scaling and root planing) within the past 6 months.

Active systemic infection, e.g., sepsis, tuberculosis. Current immunosuppressive therapy, e.g., post-transplant medications, long-term corticosteroids.

Chronic hepatitis B or HIV infection. Chronic systemic antibiotic use (\>4 weeks). Pregnancy or lactation. Anticipated survival \<12 months.
Evaluation of Lithium as a Glycogen-Synthase-Kinase-3 (GSK-3) Inhibitor in Mild Cognitive Impairment

The project is designed to generate critical information to design and justify a robust trial on lithium prevention of the onset of Alzheimer's disease (AD). Lithium exerts and inhibitory effect on Glycogen synthase kinase 3 (GSK-3) a brain biomarker of neuroprotection. The study consists of 3 phases:

1. Phase 1 investigates rats to establish a reliable method to measure brain biomarker activity levels from blood biomarker activity.
2. Phase 2 will determine whether the GSK3 enzyme activity is significantly different in subjects with MCI compared to normal individuals.
3. Phase 3 investigates patients with MCI taking lithium to establish the minimum lithium dose required to inhibit the activity of GSK-3.

Lithium has been used for decades to treat Bipolar Affective Disorder. Some of its therapeutic benefits are through the inhibition of the enzyme Glycogen Synthase Kinase-3 (GSK-3). GSK3 activity is associated with the development of several aspects of AD and thus lithium can regulate an enzyme linked to AD development. As an important step towards designing a clinical trial to investigate the potential of lithium for AD prevention the investigators propose to establish the minimum dose of lithium needed to block GSK3 in people with Mild Cognitive Impairment (MCI), a high-risk condition for progression to AD. The study will establish whether GSK3 activity is altered in MCI and monitor lithium regulation of GSK3 biomarkers in this population. At the same time the study will investigate how GSK3 measured in blood relates to GSK3 activity in the brain in a small animal study. In further preparation for a future large scale trial, this pilot study will generate technical data to develop the technique of using Magnetic Resonance Spectroscopy (MRS) as a biomarker to detect the earliest brain changes of AD.

Recruitment will be shared between the two sites for this study, Dundee and Oxford. The study will involve 12 patients with MCI and 12 controls, who will be asked for two sets of blood tests, and 20 patients with MCI who consent to take Lithium who will be asked for blood tests at regular intervals. For all participants the study period is 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Mild Cognitive Impairment (MCI).

Exclusion Criteria:

* Previous hypersensitivity to Lithium or other contraindication to Lithium carbonate Priadel (see most recent SmPC), Dementia Diabetes BMI \<18 or \>30 Rheumatoid Arthritis and Autoimmune Inflammatory disorders Currently taking NSAIDS Moderate renal failure (defined in BNF by gGFR \<60 mL/minute/1.73m2) or severe Renal failure (defined in BNF by eGFR \<29 mL/minute/1.73m2 Addison's disease, Brugada syndrome (or family history of Brugada syndrome), cardiac insufficiency, congestive cardiac failure, epilepsy, suicidality incapacity to consent currently prescribed lithium participation in another clinical trial of an Investigational Medicinal Product (IMP) in the last 28 days.

Uncontrolled serious concomitant physical illness
Eccentric Contraction-based Resistance Exercise for Chronic Stroke Patients

The purpose of this study is to develop an evidence-based rehabilitation treatment method suitable for recovery and improvement of physical function in chronic stroke patients using an eccentric overload flywheel device. Participants are disabled with chronic stroke (ischemic and hemorrhagic cerebral hemorrhage) over 50 years of age, who can communicate with a Korean simple mental state test (MMSE-K) of 24 points or higher, and whose functional gait score is 3-5 points. The investigators will enroll 40 participants and randomly assign them to either the control (Con, n=20) or the exercise (Ex, n=20) group. The investigators will verify the effectiveness of the exercise program through the evaluation of changes in muscle and physical function before and after intervention in both groups.


Eligibility Criteria:
Inclusion Criteria:

* Patients with disabilities 50 years of age or older who have been diagnosed with a stroke (ischemic and hemorrhagic cerebral hemorrhage) for at least one year
* Patients can communicate with a Korean simple mental state test (MMSE-K) of 24 points or higher
* Patients have a functional ambulation category (FAC) score of 3 to 5

Exclusion Criteria:

* Patients with brain lesions and quadriplegia excluding stroke
* Patients with uncontrolled hypertension with limited exercise intervention
* Patients diagnosed with angina
* Patients with congestive heart failure (CHF)
* Patients with upper/lower extremity fracture within 6 months
Bezlotoxumab Versus FMT for Multiple Recurrent CDI

The objective of this trial is to investigate whether a treatment strategy offering bezlotoxumab before FMT in patients suffering from multiple recurrent CDI results in equal efficacy compared with a treatment strategy with initial FMT. Strategy A includes bezlotoxumab as ancillary treatment as first option, and FMT in case of failure. Option B includes FMT as ancillary treatment as first option, and antibiotic treatment with fidaxomicin in case of failure. A secondary objective is to provide a point estimate of recurrence after bezlotoxumab for the treatment of multiple recurrent CDI.


Eligibility Criteria:
Inclusion Criteria:

* 18-90 years old
* diarrhea (3 or more unformed stools per 24h for two consecutive days; or \>= 8 unformed stools per 48h) XML File Identifier: KqQEbBLRYEZjGgsIl5GcI+NXCyM= Page 10/22
* positive PCR test for toxin A/B genes and/or positive toxin EIA for current and previous episodes (low PCR cycle threshold value when only PCR performed)
* a minimum of two prior CDI episodes
* previous episode is maximum of 3 months prior to the current episode
* the current episode responds well to Standard of Care treatment (vancomycin or fidaxomicin orally).
* Assessment of the severity of the disease will be performed according to the ESCMID recommendations.
* Both mild and severe CDI will be included

Exclusion Criteria:

* Severe complicated CDI, i.e presence of: hypotension, septic shock, elevated serum lactate, ileus, toxic megacolon, bowel perforation, or any fulminant course of disease.
* ICU admission for underlying disease
* pregnancy or current desire for pregnancy
* breastfeeding
* (prolonged) use of antibiotics (other than for treatment of CDI) during the study period or directly after the intervention
* previous use of bezlotoxumab or fecal microbiota transplantation
* a history of underlying congestive heart failure (potential safety signal phase-III trail bezlotoxumab).
* Diagnosis of inflammatory bowel disease in medical history.
Safety and Tolerability Study of Daily Dosing Rimegepant in Episodic Migraine Prevention

The purpose of this study is to further evaluate the long-term safety and tolerability of daily dosing of rimegepant for the prevention of episodic migraine.

This is a post marketing required study being conducted to further evaluate the long-term safety and tolerability of a more frequent daily dosing regimen of rimegepant for the prevention of episodic migraine.

Eligibility Criteria:
Key Inclusion Criteria:

* Subject has at least 1 year history of episodic migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following:
* Age of onset of migraines prior to 50 years of age
* Migraine attacks, on average, lasting 4 -72 hours if untreated
* Per subject report, 4-14 migraine attacks per month within the last 3 months prior to the Screening Visit (month is defined as 4 weeks for the purpose of this protocol)
* Subjects ≥ 18 years

Key Exclusion Criteria:

* Subject history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Subjects with myocardial infarction (MI), acute coronary syndrome (ACS), percutaneous coronary intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months (24 weeks) prior to the Screening Visit.
* Uncontrolled hypertension (high blood pressure) or uncontrolled diabetes.
* The subject has a history or current evidence of any unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known or suspected infection, hepatitis B or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the study
* History of use of opioid- or barbiturate- (e.g. butalbital) containing medication for 4 or more days per month during the 3 months (12 weeks) prior to the Screening Visit
* WOCBP who are unwilling or unable to use an acceptable contraceptive method or abstinence to avoid pregnancy for the entire study and for 28 days after the last dose of study drug
* Women who are pregnant or breastfeeding
* Women with a positive pregnancy test at screening or prior to study drug administration
Gram Stain of the First Urine After Puncture in Percutaneous Nephrolithotomy

In this study, investigators compared the systemic inflammatory responses after percutaneous nephrolithotomy (PCNL) patients who were given an expanded empirical antibiotic regimen based on the prediction of the possibility of bacteria identified by Gram staining the first urine after renal puncture and patients whose antibiotic regimen was not performed and whose antibiotic regimen was adjusted according to patient symptoms and culture results. Investigators aimed to test its diagnostic value in predicting and preventing complications.


Eligibility Criteria:
Inclusion Criteria:

* patients with an indication for percutaneous nephrolithotomy due to kidney stone disease.

Exclusion Criteria:

* under 18 years old,
* having an active urinary tract infection before surgery and positive urine cultures,
* Patients with bilateral kidney stones,
* DJ stent or nephrostomy placement,
* Solitary kidney stones,
* Bleeding disorders,
* impaired kidney function,
* a history of antibiotic use for any reason within 2 weeks before randomization were excluded from the study.
Effectiveness of Injury Prevention Guidelines in Recreational Runners

The aim of this trial is to investigate the effectiveness of specific training programs on the incidence of injuries in recreational runners. 408 runners between the ages of 18 and 55 years, will be recruited and randomly allocated to either the intervention group or control group. The intervention group will perform the training program twice a week in addition to their regular training. Injury data will be collected as the injuries occur and documentation of injury will follow a predetermined definition of injury. Participants will submit weekly reports of their running distance, frequency, running-related pain, as well as successful performance of the assigned training program for the intervention groups. The primary outcome is the incidence of injuries in all groups.

Injuries and especially overuse injuries within recreational running are a common occurrence with higher incidence rates in novice runners but also in recreational runners training for a specific event. The mechanisms behind overuse injury development are thought to be multifactorial and certain parameters have shown to increase injury risk in recreational runners. The aim of this trial is to target these specific parameters and implement training programs to which recreational runners will adhere for a period of 18 weeks. About 408 male and female recreational runners, aged 18-55 years will be randomly allocated to one either the intervention (INT) or Control (CON).The INT group will perform an exercise program containing muscle control and foamrolling exercises in addition to their regular training, twice a week. The CON group will continue as per usual with their training. Training data will be collected on a weekly basis from all groups and pain and injury information will be submitted by the participants upon occurrence. The primary outcome measure is the number of sustained injuries in both groups. Participants will be recruited in December 2018 and the intervention will start in January 2019 for a period of 18 weeks, ending in May 2019. Data analyses are anticipated to be completed in September 2019.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female recreational runners with an average weekly running distance of at least 15km.

Exclusion Criteria:

* Injury to the lower extremities during the past 6 months.
Proximal Pole Fractures of the Scaphoid

Aim:

The aim of this study is to analyze the clinical and radiological outcomes of patients with a proximal pole fracture of the scaphoid

Primary null hypothesis:

There are no factors associated with nonunion of a proximal pole fracture of the scaphoid.

Secondary null hypothesis:

Patients with an acute proximal pole fracture of the scaphoid have QuickDASH (Disabilities of the Arm, Shoulder, and Hand) scores at or above the population norm (a score of 13 in the Norway and 10.9 in the United States), 2 to 6 months after injury.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or greater
* Proximal pole fracture of the scaphoid on computed tomography scans made in the planes defined by the long axis of the scaphoid. The proximal pole will be defined as the proximal fifth of the scaphoid, excluding small scapholunate ligament avulsion fractures.
* Interval between injury and diagnosis of less than 2 weeks.
* English or Spanish fluency and literacy

Exclusion Criteria:

* Pregnant women
* Inability to complete enrollment forms due to any mental status or language problems (e.g. dementia, head injury, overall illness).
* Patients with other fractures or injuries
The Efficacy of Azvudine and Paxlovid in High-risk Patients With COVID-19: A Prospective Randomized Controlled Trial

This is a randomized controlled clinical study on the clinical efficacy of Azvudine and Paxlovid antivirus therapy in COVID-19 patients with high-risk. The objective is to examine the effect of high-risk on the time for COVID-19 patients to achieve 2 continuously negative SARS-CoV-2 nucleic acid test result, and the RT-PCR negative conversion rates in day 7. Patients who meet inclusion criteria will be randomized into the Azvudine group (treatment group) and Paxlovid group (control group).

After enrollment, patients will be randomized into treatment or control groups. Patients received Azvudine orally, for 7 consecutive days (7 doses in total) or Paxlovid orally for 5 consecutive days (10 doses in total). The test for RT-PCR test through either nasopharyngeal or oropharyngeal swabs were conducted on a daily basis from day 3 of their hospitalization until conversion was observed. The primary outcome was the proportion of patients acheive 2 continuously RT-PCR negative for SARS-CoV-2 at 7 days following treatment initiation, including both ORF gene Ct value≥35 and N gene Ct value≥35. Secondary outcomes included 1) the proportion of patients RT-PCR negative for SARS-CoV-2 at 14 days; 2) the time to conversion from a positive RT-PCR test to 2 continuously negative test; 3) 14-day treatment failure rate (need mechanical ventilation or high-flow oxygen therapy or death).

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-85 years (inclusive).
* Meet the diagnostic criteria for COVID-19.
* At least one high risk factor for progression to severe COVID-19
* No more than 5 days from the onset of clinical symptoms
* Sign informed consent form.

Exclusion Criteria:

* Severe or critically patients with COVID-19
* Have received neutralizing antibodies or convalescent plasma therapy due to COVID-19
* Child-Pugh grade C or acute liver failure
* Chronic renal failure (eGFR\<30 mL/min)
* Grade III or IV cardiac function, or known left ventricular ejection fraction \< 30%
* Known or suspected history of active or extrapulmonary tuberculosis
* Patients who are allergic to the active ingredient of the drug
* Pregnant and lactating women