cyrilzakka/clinical-trials huggingface dataset:
The Effects of Oxytocin on Startle Hyperreactivity in Patients With AUD and PTSD

This study will investigate the effects of oxytocin on alcohol-related behaviors, social abilities, and physiological startle responses in healthy individuals and patients with posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD) using a randomized, placebo-controlled, dose-tiered, between-subject study design. Specifically, the investigators will determine if intranasal administration of a single dose of the pro-social neuropeptide oxytocin decreases alcohol-related approach bias and cravings, enhances social abilities, and decreases physiological hyperactivity. The investigators will also determine the optimal dose to achieve these effects and will explore psychosocial predictors of responses to oxytocin. The proposed work has the potential to yield a novel pharmacological treatment for AUD and PTSD, both leading causes of disability in the US Military for which currently available treatments are inadequate.


Eligibility Criteria:
Inclusion Criteria:

1. Ages 18 to 75 (inclusive)
2. Current DSM-V diagnosis of PTSD
3. Current (past month) DSM-V diagnosis of a moderate to severe Alcohol Use Disorder

Exclusion Criteria:

1. Current or lifetime psychotic disorders, such as schizophrenia or bipolar disorder
2. Dementia or other neuropsychiatric disorders involving cognitive deficits or active symptoms impairing their ability to complete study tasks.
3. Subjects known to have clinically significant unstable medical conditions, including but not limited to clinically significant renal disease.
4. Use of disulfiram, naltrexone, or acamprosate for alcohol use disorder in the past week.
5. Needing acute medical detoxification from alcohol based on a score of 12 or more on the Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-AD);
6. Subjects who are legally mandated to participate in an alcohol treatment program.
7. Subjects who have had a suicide attempt in the past 6 months or suicidal ideation in the 90 days prior to enrollment.
8. Subjects with seizure disorders that require anticonvulsant medications
9. Positive urine pregnancy test, women meeting DSM-V criteria for premenstrual dysphoric disorder or with diseases likely to influence hormonal or neuroendocrine status
10. Sensitivity to preservatives (in particular E 216, E 218 and chlorobutanol hemihydrate)
11. Nasal obstruction, discharge, or bleeding
12. Taking testosterone or estrogen/progesterone supplement, or 5HT1a agonists/antagonists, as these agents can alter oxytocin levels
Expression of IRAK1 Gene rs1059703-related Single- Nucleotide Polymorphisms in Egyptian Patient With Rheumatoid Arthritis

Rheumatoid arthritis (RA) is known as a long-lasting inflammatory autoimmune disease affecting the diarthrodial joints, which is diagnosed by inflammation and hyperplasia in synovium, generation of RF and anti-citrullinated protein antibody (ACPA), deformity of cartilage and bone, systemic injuries involving cardiovascular, pulmonary, psychological, and skeletal disorders (McInnes and Schett., 2011).


Eligibility Criteria:
Inclusion Criteria:

* approval to sign an informed written consent, patient diagnosed rheumatoid arthritis, patient age range 17-85 year and both sexes are included.

Exclusion Criteria:

* Refusal to sign an informed written consent and patient with other autoimmune disease.
Investigating the Related Factors and Outcome of Kinesiophobia and the Effects of Multidimensional Interventions in Cardiac Surgery Patients

The primary objective of this two-year research project is to investigate the status of activity fear, its related factors, and prognosis in cardiac surgery patients in the first year. Subsequently, the study aims to develop a comprehensive intervention strategy combining exercise with cognitive-behavioral approaches tailored for cardiac surgery patients and assess the effectiveness of this intervention on activity fear, prognosis, and quality of life in the second year.

The study uses a convenient sampling method, focusing on patients undergoing cardiac surgery in the cardiac surgery ward of the Central Medical Center. The first-year research adopts a descriptive, correlational, and repeated-measures design, while the second-year research employs an experimental design. Participants are randomly assigned to either the experimental or control group. The experimental group undergoes a 12-week multidimensional interventions, while the control group receives no intervention. Data are collected through structured questionnaires. Data collection occurs at discharge, two weeks post-discharge, six weeks, 12 weeks, and 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients received cardiac surgery.
* Aged 18 or above.
* Clear consciousness and able to communicate in Mandarin or Taiwanese.
* Willing and consent to participate after being informed of the study purpose and procedures.

Exclusion Criteria:

* Cognitive impairment,
* Psychiatric disorders, and
* Long-term bedridden patients who rely on others for daily activities.
Exploratory Study to Access the Metabolic Effects of Ranolazine in Subjects With Type 2 Diabetes Mellitus When Added to Ongoing Non-insulin Antidiabetic Therapy

This study enrolled participants with inadequately controlled type 2 diabetes mellitus (T2DM) despite non-insulin antidiabetic therapy in addition to diet and exercise, and would have benefited from additional control of blood glucose levels. The study assessed the metabolic effects of ranolazine, including its effect in lowering glycosylated hemoglobin A1c (HbA1c), and lowering glucose while fasting, and following a meal (postprandial).

Participants were randomized in a 1:1 ratio to receive ranolazine or placebo, and were stratified by HbA1c ≤ 7.5% or \> 7.5%. Enrollment was to include no more than two-thirds of participants with baseline HbA1c ≤ 7.5%. Other than glucose values, efficacy endpoint results remained blinded during the study; for safety purposes, the investigator was to be alerted of severe hyperglycemia or hypoglycemia.

Participants were instructed to maintain logs of their physical activity/exercise (Subject Activity Assessment) and study drug dosing (Dosing Log).


Eligibility Criteria:
Inclusion Criteria:

* Participant with T2DM on stable non-insulin antidiabetic therapy in addition to diet and exercise
* Body mass index (BMI) ≥ 25 kg/m\^2 and ≤ 40 kg/m\^2
* HbA1c 7 - 11%
* Ability and willingness to maintain a complete and accurate Subject Activity Log during the course of the trial
* Female of child-bearing potential must have agreed to use effective methods of contraception
* Ability to understand and willing to sign written informed consent

Exclusion Criteria:

* Type 1 Diabetes Mellitus (T1DM)
* T2DM with history of or current insulin therapy. Prior use during pregnancy or gestational diabetes was acceptable.
* History of ketoacidosis or ketosis-prone diabetes
* Clinically significant complications of diabetes that in the judgment of the investigator would have made participant unsuitable to participate in this trial
* History of a severe episode of hypoglycemia
* Change in non-insulin antidiabetic therapy in addition to diet and exercise \< 2 months prior to screening
* Any clinically significant cardiovascular event \< 2 months prior to screening
* Clinically significant, inadequately controlled or unstable hypertension
* Hospitalization \< 2 months prior to screening
* Major surgery \< 3 months prior to screening
* Weight loss medication (prescription or non-prescription) \< 2 months prior to screening
Digital Interventions for Detection and Reduction of Moral Distress

Stress, anxiety, distress and depression are exceptionally high among healthcare workers at the frontline of the COVID-19 pandemic. Factors underlying distress and resilience are unknown and there are no evidence based interventions to impact the mental wellbeing of frontline healthcare workers. This study will evaluate a novel virtual reality platform to gather the "distress experience" of frontline healthcare workers at Unity Health Toronto in real time during the ongoing COVID pandemic by developing and showing feasibility of digital technology (Virtual Reality (VR) and mobile app) as a digital platform to understand the causes and ultimately reduce the moral distress of healthcare providers during the COVID-19 pandemic. The project will develop innovations which can be used for future pandemics and other contexts prone to producing moral distress and injury.


Eligibility Criteria:
Inclusion Criteria:

* Staff or healthcare providers working at Unity Health Toronto
* 18 years of age or older
* Must own a mobile phone running Android Version 6.0 and higher, or an iPhone 6 running OS 14 and higher)

Exclusion Criterion:

- Non-Unity Health Toronto staff
The Validity and Reliability of a Wearable System for Assessing Turning Characteristics.

The Validity and Reliability of a Wearable System for Assessing Turning Characteristics.

Subjects are reclaimed to finish several turning task under different turning angle.

The wearable system is patched on both subjects' legs and waist, to assess turning characteristics under different turning angle.

Eligibility Criteria:
Inclusion Criteria:

* Able to walk 10 m independently without any device.

Exclusion Criteria:

* Dizzy causing by eye disorders or vestibular disease.
* Any disease which involved in gait performance.
* Can't follow the order by investigator during task.
Apolipoprotein D (ApoD) In Human Serum As Marker Of Parkinson's Disease

In Italy affected people are 200,000 and every year Parkinson new cases are 10,000. Aging is the principle risk factor of Parkinson with the possibility of its development doubling every five years after 65. Because of the increase of the social longevity and aging as the main risk factor, there are many repercussions on the health system (hospital stays and pharmaceutical costs) as on the social system (assistance- related problems). Parkinson's disease exerts an extremely negative impact on life's quality of the patient. In fact, because of Parkinson symptoms (tremor, dribble, etc), patient's social life will be reduced with the consequent development of the depression. Consequently, the early detection and treatment of Parkinson's is necessary.

To achieve this goal, Apolipoprotein D (ApoD) in human serum as a marker of the oxidative stress-inflammation vicious cycle seems most promising candidate for diagnosis.

Total participants: n=180.

Study Part 1:

Health persons: n=90; Groups of health persons: n=3; Subjects per group: n=30.

Study Part 2:

Patients: n=90; Groups of patients: n=3; Subjects per group: n=30.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Parkinson's disease in the pathological related stages (Hoehn and Yahr)
* Persons \> 20 years

Exclusion Criteria:

* Patients with a neurodegenerative disorder different to Parkinson's disease
* Patients, who are post-ictus and/or traumatic brain injury (TBI)
* Patients, who are treated with antipsychotic drugs
* Obese persons (BMI \> 27)
* Idiopathic normal pressure idrocephalus (INPI)
* Paget's disease
* Breast cancer
* Adenocarcinoma of the prostate
* Glucose-6-phosphate (GSD-I) deficiency
* Insuline-resistance-related disorders
FDG-PET/CT in the Evaluation of Patients With Suspected Cholecystitis

This is a pilot study to investigate the ability of fluorodeoxyglucose-positron emission tomography (FDG-PET) and Positron emission tomography-computed tomography (PET/CT) as a direct method of detecting infection and/or inflammation of the gallbladder.

Hepatobiliary iminodiacetic acid (HIDA) scan scintigraphy is a nuclear medicine scan used to evaluate patients suspected of having acute cholecystitis (infection/inflammation of the gallbladder). Because it is an indirect test that looks for obstruction of the cystic duct structure, there are many causes for a false-positive HIDA study. There is a need for a more sensitive and specific test that can accurately assess gallbladder infection and/or inflammation.

The purpose of this study is to determine the effectiveness of fluorodeoxyglucose (FDG) as a direct means of detecting patients with acute cholecystitis. FDG is an imaging agent that has previously been shown to accumulate in areas of infection and/or inflammation. The location and intensity of FDG accumulation in the body can be detected with a camera system called a "positron emission tomography" (PET) camera. In theory, this test should be effective in detecting acute infection and/or inflammation of the gallbladder.

Consenting participants will receive injection of FDG one hour prior to the FDG-PET/CT examination. The participant will then be imaged using a PET/CT machine, which is a special camera system that is capable of performing both a PET and CT scan at the same time. A CT scan is an anatomical imaging test and, for this research study, will mainly be used to localize the area of 18FDG accumulation recorded by the PET scan. The examination will take approximately one hour.

Eligibility Criteria:
Inclusion Criteria:

* known or high suspicion of cholecystitis
* highly likely to undergo cholecystectomy
* positive HIDA study
* age \>18 years old
* provide written informed consent

Exclusion Criteria:

* highly unlikely to proceed to surgery or biopsy
* received an investigational drug within the past 30 days
* pregnant or lactating
* decline to provide written informed consent
Effects of Tolterodine, a Non-Specific Muscarinic Antagonist, on Gastrointestinal Transit in Healthy Subjects

The muscarinic antagonist tolterodine is widely used treat urinary urge incontinence. Though acteylcholine is the primary excitatory neurotransmitter in the gastrointestinal tract, the phase III trials suggest that tolterodine infrequently causes constipation. Therefore, the objectives of this study are to assess if tolterodine affects the speed at which food travels through the stomach, intestines and colon (i.e., gastrointestinal and colonic transit) in healthy subjects.

The specific aims of this study are to test the hypotheses that the non-specific muscarinic antagonist tolterodine will not:- i) delay colonic transit and the proximal colonic emptying rate; ii) delay gastric emptying; nor iii) delay small intestinal transit compared to placebo in healthy subjects.

Eligibility Criteria:
Age 18-70 years old. Absence of gastrointestinal symptoms as characterized by bowel symptoms questionnaire and absence of significant anxiety or depression characterized by a hospital anxiety and depression questionnaire.

Able to understand and willing to sign informed consent. Females who are nonpregnant, nonlactating, and willing to use a clinically approved methods of contraception two weeks prior to Day 0 until 1 week after the last dose of study medication.
Optimization of Cyclosporin in Atopic Dermatitis Through Multiomic Predictive Models of Treatment Response

This is a low-intervention phase IV trial. The main objective is to optimize the treatment of patients with moderate-severe atopic dermatitis who require systemic treatment.

Primary outcome is the percentage of patients with primary non- response to treatment with cyclosporin. Defined as fail to achieve EASI-75 (a 75% improvement in EASI score) at week 16 of follow-up. A 12-month recruitment period is planned and about of 100 patients with moderate-severe atopic dermatitis will be recruited. The study is divided into two cohorts. All patients diagnosed with moderate-severe atopic dermatitis who are going to receive treatment with cyclosporin in the Dermatology Service of La Paz University Hospital and associated Specialty Centers are selected in cohort 1. Patients will receive the starting dose used in routine clinical practice. All patients diagnosed with moderate-severe atopic dermatitis who are receiving or have received cyclosporin therapy in the Dermatology Service of La Paz University Hospital and associated Specialty Centers are selected in cohort 2.

Eligibility Criteria:
Inclusion Criteria:

Cohort 1:

1. Subjects diagnosed with moderate-severe atopic dermatitis who are going to receive treatment with cyclosporine.
2. Participants must be willing and able to provide written informed consent prior the initiation of any study procedures.
3. For children, parent/legal guardian must provide written informed consent. If age \>11 years old, the minor must give assent.
4. Participant is willing and able to adhere to the procedures specified in this protocol.

Cohort 2:

1. Subjects diagnosed with moderate-severe atopic dermatitis who are receiving or have received in the past treatment with cyclosporine.
2. Participants must be willing and able to provide written informed consent prior the initiation of any study procedures.
3. For children, parent/legal guardian must provide written informed consent. If age \>11 years old, the minor must give assent.
4. Participant is willing and able to adhere to the procedures specified in this protocol.

Exclusion Criteria:

1. Subjects participating in a clinical trial in the last three months.
2. Any condition or situation precluding or interfering the compliance with the protocol.
3. Women of childbearing potential must have a negative urine pregnancy test at Screening and Day 0.
4. Women of childbearing potential must commit not to become pregnant. They must be willing to use highly effective contraceptive methods or have practiced sexual abstinence during the study. Highly effective contraceptive methods include oral, intravaginal, or transdermal combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation; intrauterine device; intrauterine hormone-releasing system; bilateral tubal occlusion; vasectomised partner and sexual abstinence.
Effects of Armolipid Plus on Cholesterol Levels and Endothelial Function

Some nutraceuticals are often advised for their lipid lowering effects. Although many clinical trials have been conducted to assess their efficacy many doubts remain whether they could be considered an effective alternative to statins therapy.

The aim of this study was to evaluate the lipid lowering effects and the improvement of endothelial dysfunction in patients with hyperlipidemia, treated with a nutraceutical product (Armolipid Plus)


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged between 18 and 70
* Total cholesterol levels \> 220 mg/dl and LDL-Cholesterol \> 130 mg/dl;
* Patients with concomitant pathology such as diabetes, chronic heart failure, coronary artery disease, arterial hypertension, dysthyroidism, were admitted as long as stable in the previous three months

Exclusion Criteria:

* Proven intolerance to an Armolipid Plus compound
* Pregnant women, and women planning to conceive
* Patients in therapy with lipid lowering drugs within the previous 6 weeks
* Triglycerides concentration \> 500mg/dl were excluded.
PET Study in Patients With Non-Hodgkin Lymphoma

RATIONALE: Diagnostic procedures, such as fluorine 18-fludeoxyglucose positron emission tomography (PET) scans, may help doctors predict a patient's response to treatment and help plan the best treatment.

PURPOSE: This phase I trial is studying fluorine 18-fludeoxyglucose PET scan to see how well it predicts outcomes in patients who have undergone high-dose chemotherapy and autologous stem cell transplant for non-Hodgkin lymphoma.

OBJECTIVES:

* To determine if a fluorine 18-fludeoxyglucose positron emission tomography scan, performed as early as day 30 after high-dose chemotherapy and autologous stem cell transplantation, may be useful in identifying patients with non-Hodgkin lymphoma who may benefit from early interventions, including reduced intensity stem cell transplantation or additional therapy, to preempt disease relapse and improve overall survival.

OUTLINE: Conventional imaging, biopsy, and clinical examination findings are reviewed to determine patient clinical outcome (e.g., complete remission, disease progression/relapse, or death related to the primary disease).

Eligibility Criteria:
Inclusion Criteria:

DISEASE CHARACTERISTICS:

* Diagnosis of non-Hodgkin lymphoma
* Has undergone high-dose chemotherapy followed by autologous stem cell transplantation at Vanderbilt University between March 1997 and August 2005

  * Has undergone fluorine 18-fludeoxyglucose PET within 70 days prior to and/or at approximately 30 days and 100 days after high-dose chemotherapy and autologous stem cell transplantation

Exclusion Criteria:

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Ultrasonic Scaler VS Erythritol for Peri-implant Maintenance of Loaded Implants With Crowns Made by Different Materials

The aim of the study is to assess the effect of a 12-month peri-implant protocol with erythritol orultrasonic scaler with peek inserts for dental implants with crowns made by different materials .

Patients will be randomly divided into two groups:

Erythritol group: erythritol with a particle size of \~14 µm will be used for 5 seconds (AIRFLOW® PLUS EMS) Ultrasonic scaler group: a piezoelectric handpiece with peek inserts (Mini Piezon EMS; PI EMS) .

Different subgroups will be defined according to the material of the dental crown of the related implant.

The mechanical debridement appointments will be carried out at the baseline, after 6 months, and after 12 months, after instruction and motivation of the patient, completion of the clinical chart with the recording of the Probing Depth (evaluation in mm of the peri-implant sulcus taken by a periodontal probe; 4 surfaces of the gingival margin are detected: vestibular, palatal/lingual, mesial, distal), Bleeding on Probing and Plaque Control Record.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 70
* Presence of at least one dental implant
* Good compliance

Exclusion Criteria:

* Patients with cardiac stimulators
* Patients with neurological disorders
* Patients with psychological disorders
* Pregnant women
The Relationship Between Maximal Oxygen Consumption and Inspiratory Muscle Activation Pattern Under Loaded Inspiratory Muscle Tests in Healthy Adults

Maximal oxygen consumption, VO2max, is the gold standard to evaluate human aerobic fitness, which stands for the maximal capacity of cardiorespiratory system and musculoskeletal system to transport and utilize oxygen. Previous study showed that there is significant correlation between maximal oxygen consumption from cardiopulmonary exercise test and strength and endurance of lower extremities. In people with sedentary lifestyle, they often limited by the lower limb muscle performance during cardiopulmonary exercise test. Their breathing patterns are more irregular than athletes during cardiopulmonary exercise test. However, there is no study comparing the activation pattern of respiratory muscles between these two groups. Whether the breathing pattern in people with lower exercise capacity is less efficient under exertional activities still unknown. The purpose of this study is to investigate the relationship between maximal oxygen consumption and inspiratory muscle activation pattern in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults (age \> 20 years old)
* Be able to cooperate with the measurements of this study

Exclusion Criteria:

* any clinical diagnosis that will influence the measurement, including any history of neuromyopathy
* angina, acute myocardial infarction in the previous one month
* pregnancy
* history of syncope during exercise
* any musculoskeletal system disorder that unable to perform cardiopulmonary exercise test