cyrilzakka/clinical-trials huggingface dataset:
Effects of Oxytocin on the Functional Architecture of the Brain Before and After Prolonged Naturalistic Fear Induction

The main aim of the pharmacological resting-state fMRI study is to investigate the modulatory effects of intranasal Oxytocin (24IU) on task and intrinsic functional connectivity before and after prolonged exposure to naturalistic fear induction via a movie.

In a double-blind placebo-controlled between-subject experimental design, 60 adult male subjects will be randomly allocated to either receive intranasal Oxytocin (24IU, n= 30) or intranasal placebo (nasal spray administration without oxytocin, n = 30). Following treatment administration subjects will undergo a resting state functional magnetic resonance imaging (fMRI) assessment (8min) and next watch a long fear-inducing (horror) movie (10min) followed by a resting state fMRI assessment (8min). Effects of treatment on subjective experience will be assessed using 1-9 Likert scales assessing subjective fear, emotional arousal and escape. Ratings will be acquired before the start of the experiment, after the movie and at the end of the experiment. Participants will undergo screening for psychopathological and emotional states before treatment. Together with a randomized assignment to the treatment groups, this will allow controlling for confounding between-group differences.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects without past or current psychiatric or neurological disorders
* Right-handedness
* Normal or corrected-normal version

Exclusion Criteria:

* History of head injury
* Medical or psychiatric illness
* Hypertension
* General cardio-vascular alteration or diseases
* Allergy against medications
* Visual or motor impairments
* Claustrophobia
* Drug addiction
* Nicotine dependence
* FMRI contradictions
A Safety Study of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open Angle Glaucoma

The purpose of this study is to determine if the Punctal Plug Delivery System is safe and effective in controlling intraocular pressure in patients with ocular hypertension or open-angle glaucoma.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 yrs with ocular hypertension or open-angle glaucoma
* Subjects who have a best-corrected visual acuity of 20/100 or better.

Exclusion Criteria:

* Subjects who wear contact lenses.
* Uncontrolled medical conditions
* Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic topical medications.
* Subjects who have a history of chronic or recurrent inflammatory eye disease.
Study Evaluating Safety, Tolerability and Efficacy of YM150 in Subjects With Acute Coronary Syndromes

The purpose of this study is to evaluate the safety and efficacy of various doses of YM150 (the experimental drug) in the prevention of ischemic vascular events in subjects with recent acute coronary syndromes.


Eligibility Criteria:
Inclusion Criteria:

* has a diagnosis of STE-ACS, NSTE-ACS as index event according to accepted guidelines such as the ESC or AHA guidelines
* has elevated cardiac biomarkers

Exclusion Criteria:

* is planned for myocardial revascularization (e.g., Coronary Artery Bypass Graft (CABG) or elective or staged PCI) or any other invasive procedure with increased risk for bleeding (i.e. elective surgical procedures) within 60 days after randomization
* has had recent stroke or TIA ≤ 12 months prior to index event
* has persistent BP of 160 mmHg systolic or higher and/or 100 mmHg diastolic or higher at baseline with or without medication
* has participated in another clinical trial of an investigational drug (including placebo) or device within 30 days (or the limit set by national law, whichever is longer) of signing informed consent for the present study
* has participated in any YM150 clinical trials
* requires ongoing parenteral or oral anticoagulant therapy
* has active bleeding or is in the opinion of the investigator at high risk of bleeding during the study
CKD-330 Drug-Drug Interaction Study (Amlodipine)

The purpose of this study is to evaluate a pharmacokinetic drug interaction and safety of Amlodipine between free combination of Amlodipine and Candesartan and Amlodipine monotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male volunteer is between 20 and 45 years of age(inclusive) at the pre-study(screening).
2. Volunteer who has 19kg/m² ≤ BMI(Body Mass Index) ≤ 26kg/m²
3. When volunteer in screening, Must include under the items.

   1. 100 mmHg ≤ sitting SBP \<140 mmHg
   2. 60 mmHg ≤ sitting DBP \< 90 mmHg
   3. 45 bpm ≤ Pulse \< 95 bpm
4. Those who decided to join the clinical trials by themselves and to comply with the precautions written consent.

Exclusion Criteria:

1. A previous history or present of clinically significant liver, renal, gastro-intestinal, pulmonary, musculoskeletal, endocrine, neuropsychiatric, hemato-oncological, cardiovascular disease.
2. Have a gastrointestinal disease history that can affect drug absorption(Crohn's disease, Ulcers, GERD, Gastritis, etc.) or surgery (except simple appendectomy or hernia surgery).
3. The history of clinically significant hypersensitivity reaction about Investigational drugs and foods.
4. The history of drug abuse or drug abuse showed a positive for urine drug test.
5. Taking drugs have received any other investigational drug within 90 days prior to the first dosing and metabolizing enzyme inducers or inhibitors such as barbitals within 30 days prior to the first dosing.
6. Whole blood donation within 60 days prior to the first dosing or plasma donation within 30 days prior to the first dosing.
7. Taking drugs that clinical trials expected to affect within 14days or taking food containing caffeine, grapefruit within 7days before the first dosing.
8. A heavy alcohol consumer(alcohol\>3cup/day or 3times/week within last 1month)
9. A heavy smoker(cigarette\>10cigarettes/day)
10. The subject has positive results of serum tests(Hepatitis B, C, HIV Test, Syphilis).
11. Have the Liver enzyme levels(AST, ALT) or Bilirubin, total results greater than 1.5 times the UNL.
12. Have the result of Creatinine clearance is less than 80mL/min(Cockcroft-Gault equation applicable).
13. The result of 12-lead ECG in screening test is QTc\>450msec.
14. An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.
Open Label Extension Study of STX209 (Arbaclofen) in Autism Spectrum Disorders

This is an open-label extension protocol that will provide necessary data on the safety, tolerability, pharmacokinetics and efficacy of STX209 among subjects with ASD.

This is an open label extension study enrolling by invitation only to those subjects that have completed Seaside protocols 209AS208 and 22007.

Protocol 209AS208, "A Randomized,Double-Blind, Placebo-Controlled, Study of the Efficacy, Safety, and Tolerability of STX209 (Arbaclofen) Administered for the Treatment of Social Withdrawal in Subjects with Autism Spectrum Disorders."

Protocol 22007, "An Open Label Extension Study to Evaluate the Safety, Tolerability and Pharmacokinetics of STX209 in Subjects with Autism Spectrum Disorder."

This open-label extension will provide data on the following:

1. Evaluate the safety and tolerability of long term use of STX209 (Arbaclofen)
2. Provide supporting pharmacokinetic analyses
3. Assess long term efficacy on social behaviors in subjects with ASD.

Eligibility Criteria:
Inclusion Criteria:

* Subject completed study 22007 or 209AS208, and showed he can adequately follow the protocol, and with adequate medical justification to enter this study.
* Parent or other legally-authorized representative or caregiver is willing and able to perform all protocol-specified functions.
* Treatment with no more than 2 psychoactive medications
* Subjects with a history of seizure disorder must be adequately well-controlled, as specified in the study protocol
* For female subjects, negative pregnancy test

Exclusion Criteria:

* Comorbid conditions that might interfere with the conduct of the study or confound the interpretation of the study data, or endanger the subject.
* Current use of illicit drugs or alcohol abuse.
* Subjects with a serious adverse event or other adverse event in study 22007 or 209AS208 that was related to STX209, and that endangers the subject, in the opinion of the investigator
* Current use of another investigational drug, or of vigabatrin, tiagabine, or riluzole
Timing of Smoking Intervention in Alcohol Treatment (Nicotine Patch)

This study will attempt to determine the best time to begin a smoking cessation program in individuals who undergo intensive treatment for alcohol dependence. The goal of this trial is to determine whether a smoking cessation program is more effective if it occurs at the same time as or after treatment for alcohol dependence. The study also will attempt to determine the effect of smoking cessation programs on the outcome of treatment for alcohol dependence.


Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for alcohol use disorder and other drug dependence.
* Complete first week of alcohol treatment program.
* Current cigarette smoker (more than 5 cigarettes/day, smoking more than 1 year).

Exclusion Criteria:

* Lifetime diagnosis of an excluding psychiatric disorder: bipolar disorder, schizophrenia or other psychotic disorder, panic disorder with or without agoraphobia, obsessive-compulsive disorder, generalized anxiety disorder, eating disorder, post- traumatic stress disorder, antisocial personality disorder, or borderline personality disorder.
* Unable to participate in protocol due to functional deficits or severe depression.
* Suicidal or homicidal ideation.
* Current use of disulfiram (Antabuse) or naltrexone (Revia).
* Current use of pipes, cigars, or smokeless tobacco and unwillingness to stop.
* Lives more than 100 miles from alcohol treatment facility.
* No telephone.
A Nurse Caring Behavior Protocol on Postoperative Cardiac Patient Satisfaction

the study aimed to evaluate the impact of implementing a nurse caring behavior (NCB) protocol on postoperative cardiac patient satisfaction.

Critical care nurses need to comply with caring behaviors when caring for postoperative cardiac patients. Furthermore, patient satisfaction is a key indicator of nursing care quality. As such, this study focused on these critical issues considering the limited research available on the impact of caring behaviors on postoperative cardiac patient satisfaction. The study aimed to evaluate the impact of implementing a nurse caring behavior protocol on postoperative cardiac patient satisfaction. The study was conducted at a cardiac surgery intensive care unit of Alexandria Main University Hospital, Egypt. Sixty adults, conscious cardiac surgery patients, were included during the first 2 days following surgery. Patients were randomly assigned to either a control group, which received routine nursing care, or a protocol group, which received nursing care based on nurse care behaviors protocol through a simple randomization method. One tool was used "Postoperative Cardiac Patient Satisfaction with Nurse Caring Behaviors Evaluation Questionnaire". At the end of the second day, patients were asked regarding their satisfaction with the nursing care received based on caring behaviors. These nursing care included intensive care unit admission and orientation processes, physical care, psychological care, and social interaction between patient and nurse, providing health teaching, and maintaining a safe healing environment.

Eligibility Criteria:
Inclusion Criteria:

* Underwent cardiac surgery.

Exclusion Criteria:

* Unstable hemodynamics (systolic blood pressure less than 90).
* Uncontrolled dysrhythmias.
* Hemorrhage.
* Uncontrolled diabetes mellitus.
* Chronic respiratory diseases.
Lymphedema Surveillance Study

This study is being done to find out how many women develop lymphedema after an axillary lymph node dissection. The investigators also want to look for reasons why some women get lymphedema and others don't. Specifically, the investigators want to do tests on the breast tissue that is removed at the time of surgery to see if they can identify inflammation in the breast tissue, which may increase a woman's risk for lymphedema. The investigators will also ask the patient to answer questions to see how much their quality of life is affected by lymphedema, and whether this study can help women by detecting lymphedema earlier.


Eligibility Criteria:
Inclusion Criteria:

* Female breast cancer patients over the age of 18
* Patients consenting for unilateral axillary lymph node dissection (ALND) (prior history of sentinel lymph node biopsy allowed if \<6 months from consent)
* Patients consenting for unilateral sentinel lymph node biopsy (SLNB) and possible ALND are eligible for initial entry into the study, but will become ineligible if ALND is not performed
* Initially consented patients, treated with SLNB alone, who were originally considered ineligible to continue on study, will be approached for re-enrollment
* Patients who self-identify as Black or White consenting for unilateral ALND or possible ALND will be approached for enrollment onto translational study (Cohort 3)

Exclusion Criteria:

* Male breast cancer patients
* Patients consenting for bilateral axillary surgery
* Patients with prior history of surgical excision of one or more axillary lymph nodes or SLNB, performed \>6 months from date of consent
* Patients with prior history of ALND
* Patients with no breast surgery performed at MSK
Native Tissue Repair With Surgical Pelvic Organ Pessary - an RCT

This is an RCT looking at the primary outcome of composite success following anterior repair with native tissue at 6, 12, 24 months in two arms. One arm will be randomised to have a soft silicone pessary inserted into the vagina post operatively for three weeks and the other will not.

Prolapse of the vagina is a common problem for women and varies from mildly bothersome to very problematic. About one in ten women in the developed world will require surgery for prolapse in their lifetime. The results of surgery are not perfect and some of women will develop prolapse again or not be satisfied with the result.

In this study a soft silicone support (SPOP) is inserted into the vagina straight after prolapse surgery. Women who have agreed to the study will be randomly chosen to have the SPOP at the time of surgery. There will be 120 patients in the study; so 60 women will have the SPOP inserted.

The investigators think that SPOP will support the vagina as it heals, improving the results of surgery. There are already some studies of the SPOP with other surgeries that show improved results. The SPOP is inserted while the patient is sleeping and is removed four weeks after surgery. It is attached with two dissolving stiches to the vagina. After four weeks is will be removed in the out patient clinic without any discomfort. It is not usually painful or uncomfortable at any time.

The actual surgery the women have will not be any different had they not been in the study. All the women in the study will have the normal assessment prior to their operation, and will fill out some questionnaires about their symptoms too. All women involved in the study will come back the clinic to be seen after six months, one year and two years from the date of the surgery. This is regardless of whether they had the SPOP or not. When the women return they will be examined and complete the questionnaires again each visit.

The results of the study will be reported and published.

Eligibility Criteria:
Inclusion Criteria:

* Women with symptomatic pelvic organ prolapse requiring an anterior vaginal repair at the study centre.
* Currently on the hospital waiting list for vaginal native tissue repair
* Willingness to participate
* Medically fit for surgery
* 18 years or over
* Reasonable level of English to complete questionnaires
* Patients have not been recommended surgery that involves colpocliesis, mesh, or laparoscopic approach

Exclusion Criteria:

* Asymptomatic pelvic organ prolapse
* Refusal to participate
* Medically unfit for surgery
* Under 18
* Unable to complete questionnaires due to poor level of english
* Patients has been recommended surgery that involves colpocliesis, mesh, or laparoscopic approach
Epicardial Adipose Tissue Thickness in Polycystic Ovary Syndrome (PCOS)

The aim of the present study was to search whether epicardial adipose tissue thickness, a predictor of increased cardiovascular risk, increases in PCOS patients or not and, if it does, to analyze the relationship of EATT with insulin resistance, adiponectin and biochemical and anthropometric parameters.

Context: Polycystic ovary syndrome (PCOS) is characterized with chronic oligo/unovulations, hyperandrogenism and insulin resistance. Insulin resistance is mostly attributed to visceral adipose tissue. Epicardial adipose tissue thickness (EATT) is in close relation with atherosclerotic coronary heart disease and its importance in PCOS is not determined yet. Thus, we aimed to clarify EATT in patients with PCOS and compare with healthy matched controls. In addition we searched plasma adiponectin levels to clarify its relationship with EATT in patients with PCOS.

Settings: EATT was determined by echocardiography. Insulin resistance is calculated as HOMA-IR and plasma adiponectin levels were determined with ELISA radioimmunoassay at Gülhane School of Medicine, Ankara, Turkey.

Patients: Patients with PCOS and healthy controls who were similar in body mass index (BMI) and age (p=0.118, p=0.081, respectively) were enrolled in the study after having their written consents.

Results: Mean EATT and HOMA-IR levels were significantly higher (p=0.001, p=0.001, respectively) while plasma adiponectin concentrations were significantly lower (p=0.0032) in patients with PCOS than controls. There was no correlation between plasma adiponectin levels and EATT in subjects (p=0.824). EATT levels were in positive correlation with HOMA-IR, plasma triglyceride concentrations and body mass index (BMI) (p=0.022, p=0.027, p=0.022, respectively). HOMA-IR, triglyceride levels, HDL-Cholesterol, LH/FSH ratio were most powerful determinants of EATT in logistic regression modeling (p=0.016, p=0.021, p=0.049, p=0.039, respectively).

Conclusion: EATT is increased in patients with PCOS in concordance with HOMA-IR level and these findings may reflect the increased risk for atherosclerotic cardiovascular disease in this particular patient group.

Eligibility Criteria:
Inclusion Criteria:

* pcos patients, all of the women had normal thyroid-stimulating hormone and prolactin levels, and subjects without possible ovarian tumors, congenital adrenal hyperplasia

Exclusion Criteria:

* BMI greater than 35 kg/m2, any chronic renal or liver disease
HER2 Expression Detection in Breast Cancer Using 99mTc-NM-02

A 99mTc-labeled anti-HER2-sdAb (99mTc-NM-02) will be developed for SPECT/CT assessment of HER2 expression in breast cancer patients. Its safety, radiation dosimetry and biodistribution, and the relationship between tumor uptake and HER2 immunohistochemistry results will be investigated.

To evaluate the safety, dosimetry and efficacy of 99m-Tc labeled anti-HER2 single domain antibody (sdAb) (Product Code Name: 99mTc-NM-02) SPECT/ CT imaging of HER2 expression in Breast Cancer and compare it with the existing gold standard " HER2 expression detection" by biopsy tissue immunohistochemistry (IHC) and/or Fluorescence In Situ Hybridization (FISH) method. It is also to establish a new clinical method of non-invasive HER2 expression detection in breast cancer using 99m-Tc labeled anti-HER2 sdAb

Eligibility Criteria:
Inclusion Criteria:

1. Adult female, age 18 years or older
2. Prior diagnosis of breast cancer
3. Willing to participate in this study and given written informed consent
4. AST, ALT, BUN, Cr not more than double the normal values
5. Subjects of childbearing potential must be willing to undergo a pregnancy test prior to enrolment

Exclusion Criteria:

1. Pregnancy (subjects with a positive pregnancy test at baseline screening period or who are planning to become pregnant during the study period)
2. Breastfeeding (subjects in lactation)
3. No biopsy tissue sample can be provided for HER2 expression detection
4. Subjects with pacemakers
5. Hepatitis B virus infection (including carriers) at screening, ie hepatitis B surface antigen (HBsAg) positive, or hepatitis C antibody (anti-HCV) positive, or acquired immunodeficiency disease (HIV) infected, or serum syphilis positive person
6. Abnormal liver function during baseline screening period : AST or ALT\> 2 times the upper limit of normal value (ULN), if the marginal increase of a single index is judged as having no clinical significance by the investigator, it can be retested during the screening period. Once, if ≤ 2 times ULN after retesting, consider enrolling).
7. Impaired renal function during screening: serum creatinine or urea nitrogen \> 1.5 times ULN.
8. Within 4 months prior to the baseline screening period , myocardial infarction or other cardiac events requiring hospitalization (unstable angina, etc.), cerebrovascular accident, transient ischemic attack, acute congestive Heart failure or severe arrhythmia (ventricular arrhythmia, atrioventricular block above II)
9. Subjects with pulmonary embolism or deep vein thrombosis
10. Various infections that the investigators consider unsuitable for study, including but not limited to patients with various infections requiring further treatment, such as urinary tract infections, respiratory infections, and diabetic foot infections.
11. Patients with abnormal thyroid function during baseline screening period (including but not limited to active hyperthyroidism, hypothyroidism or Hashimoto's thyroiditis)
Role of Infected Blood Dendritic Cells in Heart Disease Risk

The investigators hypothesize that blood dendritic cells harbor pathogens from the oral cavity in chronic periodontitis and disseminate these pathogens to atherosclerotic plaques.

To address this hypothesis, a clinical study in humans with moderate to severe chronic periodontitis has been designed. This is an interventional study involving scaling and root planing and two arms: 1. treatment with PO amoxocillin/metronidazole plus chlorhexidine oral rinse; 2. no antibiotics or oral rinse. It is expected that the antibiotics plus chlorhexidine will prevent the dendritic cell response to infection (bacteremia) elicited by scaling and root planing.

Eligibility Criteria:
Inclusion Criteria:

* generalized moderate to severe chronic periodontitis

Exclusion Criteria:

* diabetes
* antibiotics treatment within 3 months
* treatment with steroids, phenytoin, cyclosporin, coumadin
* presence of conditions requiring prophylactic antibiotics per AHA
* cancer, HIV, hepB, lupus, prediagnosed heart disease, renal disease
* smoker