cyrilzakka/clinical-trials huggingface dataset:
I-123 Brain Studies of Serotonin Metabolism in Psychiatric Patients and Normal Volunteers

Abnormalities in the re-uptake of dopamine and serotonin have been described in various neuropsychiatric disorders and substance abuse. \[I-123\] Beta-CIT is a recently developed radioligand for SPECT imaging of dopamine and serotonin transporters. \[I-123\]Beta-CIT SPECT has been used at the SPECT-lab of the Clinical Brain Disorders Branch in over fifty subjects without adverse events. Due to the trace concentrations used, a pharmacological effect of Beta-CIT is unlikely and has not been observed. The purpose of this study is to use Beta-CIT and SPECT to study the expression of dopamine and serotonin transporters in vivo in normal controls and various patient populations to address hypothesized abnormalities of the transporters in different disorders and to understand the effects of genetic variations in the genes of these transporters on their in vivo expression.

Abnormalities in the re-uptake of dopamine and serotonin have been described in various neuropsychiatric disorders and substance abuse. \[I-123\] Beta-CIT is a recently developed radioligand for SPECT imaging of dopamine and serotonin transporters. \[I-123\]Beta-CIT SPECT has been used at the SPECT-Lab of the Clinical Brain Disorders Branch in over fifty subjects without adverse events. Due to the trace concentrations used, a pharmacological effect of Beta-CIT is unlikely and has not been observed. The purpose of this study is to use Beta-CIT and SPECT to study the expression of dopamine and serotonin transporters in vivo in normal controls and various patient populations to address hypothesized abnormalities of the transporters in different disorders and to understand the effects of genetic variations in the genes of these transporters on their in vivo expression.

Eligibility Criteria:
INCLUSION CRITERIA:

No Axis I or Axis II diagnoses.

EXCLUSION CRITERIA FOR ALL SUBJECTS:

If the pregnancy test is positive or if the woman has reason to believe she might be pregnant, she will be excluded from this study.

Women who are breastfeeding will be excluded from this study to avoid unwarranted risk to their children.

Subjects with a prior reaction to iodine, iodine compounds, or shellfish will be excluded from this study.

Subjects with a history of thyroid disease or dysfunction will be excluded from this study.

Subjects with a history of recent substance abuse will be excluded from this study.

Subjects with metal objects in their bodies as specified in our MRI protocol (91-M-0124) will be excluded from this study.

If a structural abnormality of the brain is detected on MRI, subjects will be excluded from the study.

EXCLUSION CRITERIA FOR NORMAL CONTROLS:

Subjects with an Axis I or Axis II disorder will be excluded.

Subjects with concomitant medical or neurological disorders which require ongoing medication, or which may affect the central nervous system will be excluded.
Effectiveness of Pre-administered Natural Sweet-tasting Solution (Honey) for Decreasing Pain of Needle Insertion

This study aims to assess Effectiveness of Pre-administered Natural Sweet-tasting Solution (honey) for Decreasing Pain Associated with Dental Injections (infiltration) prior to dental extraction in 6-8 years old healthy Children (first dental visit) In comparison to topical anesthesia.

The administration of local anesthetics is one of the most dreaded or anxiety-inducing triggers in a dental setup. Patients, particularly children, may be fearful of dental injections, which may prevent them from seeking dental treatment. Even though profound local anesthesia aids in the treatment of pediatric patients in terms of reducing their anxiety and pain during restorative and surgical procedures, the fear of needles has been cited as a barrier to develop proper dental care. Numerous techniques have been researched in an attempt to minimize the pain and distress associated with these dental injections, varying from localized methods to distraction techniques. The localized methods include application of topical agents, altering the rate of injection, increasing the pH of local anesthetics by buffering and pretreatment with lasers. Instruments such as CCLA System (computer-controlled local anesthetic delivery system) and dental vibe are also available to make dental injections more comfortable. Studies have found that sweet flavored solutions, mainly 30% sucrose, given orally prior to cutaneous procedures can reduce discomfort in neonates undergoing heel sticks and venipuncture. Effectiveness of sucrose in the treatment of, procedural pain in newborns and babies has been verified in a Cochrane reviews.

Eligibility Criteria:
Inclusion Criteria:

1. Children within the age group 6 to 8 years were selected since the cognitive skills necessary for the use of visual analogue scale for pain assessment have not developed in children younger than 6 years of age.
2. Mobile deciduous second molars bilaterally that could be treated under infiltration anesthesia.

Exclusion Criteria

1. History of allergy to any components of local anesthetic agents used during the study.
2. Dental or dentoalveolar abscess.
3. Presence of any underlying systemic disease.
4. Immunocompromised patients.
RCT: STARR vs Biofeedback

This study aimed to evaluate the safety and symptomatic outcomes achieved with Stapled Transanal Rectal Resection (STARR) compared to biofeedback training in patients with obstructed defecation syndrome (ODS).


Eligibility Criteria:
Inclusion Criteria:

1. Female patients \>18 years old
2. Able to comprehend, follow, and provide written informed consent.
3. Minimum ODS Score of seven at screening.
4. Negative pregnancy test, by urine.
5. 'Obstructed' defecation requiring straining/digitation as presenting lead symptom.
6. Adequate external sphincter on rectal digital examination.
7. Evidence of anterior rectocele and/or rectal intussusception on dynamic defecography. (Note: dynamic defecography taken within 12 months will be acceptable)
8. Willingness to comply with study requirements including follow-up visits

Exclusion Criteria:

Evidence of external sphincter injury associated with incontinence.

1. Enterocele at rest- requiring surgery.
2. Faecal incontinence (soiling and faecal urgency is admissible).
3. Any anterior defect, colpocele or cystocele requiring a combined surgical approach.
4. Physical or psychological condition which would impair participation in the study.
5. Participation in any other device or drug study within 90 days prior to enrollment.
6. Planned participation in any other device study during the timeframe of this study.
7. General contraindication for surgery.
8. Previous transanal surgery for ODS.
9. Immunocompromised subjects
BTRX-246040 Administered Once Daily to Patients With Major Depressive Disorder

This study will determine the efficacy, safety, and tolerability of a once-daily (QD) dose of up to 80 mg of BTRX-246040 for 8 weeks in participants with MDD.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of MDD as defined by DSM-5 criteria and have had at least 1 prior major depressive episode in the past 10 years
* Patients must present with a new current episode of MDD and the duration of the current episode must be at least 4 weeks but not longer than 18 months.
* At Visit 1 (screening) and Visit 2 (baseline), patients must have clinically significant depressive symptoms defined by tandem (investigator- and computer-administered) Montgomery-Asberg Depression Rating Scale (MADRS) total scores ≥ 26 with a difference of ≤ 7 points between the Investigator- and computer-administered MADRS total scores
* Patients must have a CGI-S score ≥ 4 at Visit 2 (baseline).

Exclusion Criteria:

* Patients who present with any current DSM-5 disorder other than MDD which is the focus of treatment.
* Patients who are homicidal in the opinion of the Investigator or are at suicidal risk (any suicide attempts within 12 months prior to Visit 1 \[screening\] or any suicidal intent, including a plan, within 3 months prior to Visit 1 \[screening\]; C-SSRS answer of "YES" on item 4 or 5 \[suicidal ideation\]; Investigator- or computer-administered MADRS score of ≥ 5 on item 10 \[suicidal thoughts\]; by Investigator clinical evaluation).
* Patients cannot have any history of substance or alcohol use disorder within 12 months prior to Visit 1 (screening) per DSM-5 criteria
* Patients must not have a clinically significant comorbid disease.
The Use of Liraglutide in Brain Death

There is evidence of the association of brain death and inflammation, affecting outcomes of transplanted organs, but in a way not fully understood. Observational studies suggest that the use of target-guided therapies has a beneficial effect in reducing the rate of donor loss due to cardiac arrest and increasing the rate of donor-picked organs, which will be tested through the randomized clinical trial. However, no study so far has directly tested the effect of drugs with anti-inflammatory and anti-apoptotic properties administered to the donor in encephalic death in reducing inflammation of organs to be transplanted. This study aims to evaluate the use of liraglutide in patients with brain death in relation to their ability to attenuate the inflammation induced by encephalic death by means of a randomized clinical trial.

The intervention group will be composed of individuals deceased in brain dead, after the conclusion of the brain dead protocol by the teams responsible for the Intensive care and will receive liraglutide. The control group will be composed of the same population of individuals who died in brain dead of the intervention group, but will receive a placebo.

Eligibility Criteria:
Inclusion Criteria:

* individuals deceased more than 18 years after the end of the brain death protocol

Exclusion Criteria:

* Pregnant women, patients with advanced renal failure on hemodialysis, with hepatic insufficiency or allergy known to liraglutide
Observational Study to Assess Oxygen Saturation Predictive Power Related to Intradialytic Acute Hypotension

The aim of the present work was to analyze the short-term variability of SO2 during hemodialysis in sessions with and without hypotension to correlate the SO2 variability to hemodynamic instability.

During the last 40 years a lot has been achieved in dialysis regarding both monitors safety and membranes overall performances Anyway, intradialytic symptoms still remain a major concern for nephrologists: in particular, hypotension is the most frequent \[1\].

Intradialytic hemodynamic monitoring systems have been developed to have continuous surveillance of the main hemodynamic variables (heart rate, body temperature, blood pressure itself, cardiac output, ecc...).

In a second moment, the further evolution was towards the retroactive control systems, to force some of the variables involved in the genesis of the hemodynamic stability, along a pre-determined, ideal, trend. In this view, various bio-feedback mechanisms have been proposes along the years, for example, to tackle hypovolemia-related hypotension. Their scientific rationale is the control of either blood volume or directly natremia, in order to pilot plasma refilling towards the vascular compartment \[2\].

Despite the great achievements obtained, the forecasting of acute hypotension during hemodialysis still remains a complex problem, likely involving more than one variable.

SO2 can be considered an indirect expression of the hemodynamic stability. Moreover, in dialysis, it has always been regarded as a bio-compatibility marker for membranes \[3\]. Nowadays, SO2 changes during dialysis are easy to measure with a fully, non-invasive sensor assembled on the arterial line.

We planned this study to analyze on a large number of sessions the short-term variability of SO2 during hemodialysis in relationship with hemodynamic tolerance.

Eligibility Criteria:
Inclusion Criteria:

* Dialysis vintage \> 6 months
* Well functioning arterovenous fistula or central venous catheter
* thrice weekly HD treatment schedule
* Acute hypotensions in the last month before study start \> 20% of sessions

Exclusion Criteria:

* Mental illness
* life expectancy \< 6 months
* any profiling and/or biofeedback strategies routinely prescribed
To Evaluate the Efficacy of a Nutraceutical in Reducing Cardiovascular Risk in Healthy Subjects

Single-blind, double-blind, controlled, randomized clinical trial of two parallel branches depending on the product consumed (experimental product and placebo product) and single-center with the objective of evaluating the effect of the investigational product on cardiovascular risk reduction.

Subjects who meet the selection criteria will make a total of two visits to the research laboratory and will carry out the tests established in the protocol. Subsequently, a statistical analysis will be performed with the variables measured in the study to obtain results.

Eligibility Criteria:
Inclusion Criteria:

* Subjects of both sexes (men or women) between 30 and 75 years of age, Caucasian.
* Present body mass index between 20 and 32 Kg / m2.
* Presenting fasting serum LDL-cholesterol levels equal to or greater than 110 mg / dL or total serum cholesterol equal to or greater than 180 mg / dL.
* Volunteers capable of understanding the clinical study and willing to grant written informed consent and to comply with study procedures and requirements.

Exclusion Criteria:

* Thyroid dysfunction, infections, or with any type of chronic disease (eg, autoimmune, inflammatory).
* Subjects who have suffered an ischemic-vascular event in the last months.
* Subjects in medication and / or nutraceutical treatment for hypertension, diabetes or hyperlipidemia (ex: statins).
* Subjects in treatment with drugs that due to their narrow therapeutic margin require monitoring of their plasma levels (digoxin, acenocoumarol, warfarin, etc ...).
* Subjects in treatment that affects body weight or appetite.
* History of allergic hypersensitivity or poor tolerance to any component of the products under study.
* Subjects who are carrying out or intend to carry out any type of diet, low-calorie or not, during the study.
* Subjects who have donated a minimum of 0.5L of blood in the last month Vegetarian subjects.
* Subjects who have ingested omega 3 and / or 6 supplements in the last three months, (eg, fish oil, evening primrose oil, krill oil, or algae oil).
* Subjects under treatment with niacin or fibrates.
* Those subjects with alcohol abuse, or with excessive alcohol consumption (\> 3 glasses of wine or beer / day) were excluded.
* Patients undergoing major surgery in the last 3 months.
* Smoking subjects or not, but in any case who have changed their nicotinic habits during their participation in the study.
* Participation in another clinical trial in the three months prior to the study.
* Lack of will or inability to comply with clinical trial procedures.
* Subjects whose condition did not make them eligible for the study according to the researcher's criteria.
Investigation of the Effect of Exercise Training on Psychosocial Outcomes in Rotator Cuff Tears

This study aimed to determine the psychosocial effects of exercise training in patients with rotator cuff tears.

This study aimed to determine the psychosocial effects of exercise training in patients with rotator cuff tears. Fifty voluntary patients with partial rotator cuff tear will be randomized into two groups: Supervised exercise group (SE) and home exercise (HE) group, for a standardized 8 weeks exercise program. The primary outcome is the Constant-Murley Score (CMS). The secondary outcomes are the Visual Analogue Scale (VAS), active range of motion (AROM), Pain Catastrophizing Scale (PCS), Hospital Anxiety and Depression Scale (HADS), Pittsburgh Sleep Quality Index (PSI), Short Form-12 (SF-12), and Global Rating of Change (GRC). Outcome measures will be performed at baseline and at the end of 8-week intervention.

Eligibility Criteria:
Inclusion Criteria: Forty years of age or older patients that have been diagnosed for a partial rotator cuff tear that is unrelated to trauma by a specialist orthopedist with MRI and physical examination and no other shoulder problems on the diagnosed shoulder will be included into this study.

Exclusion Criteria: Patients diagnosed with full-thickness or massive rotator cuff tear, patients who undergone previous surgery, patients diagnosed with frozen shoulder or glenohumeral instability, and athletic patients younger than 40 years of age with symptoms of acute RC tear will not be included into this study.
Bipolar Radiofrequency Ablation -Role in Prevention of Postoperative Atrial Fibrillation

Atrial Fibrillation (AF) is one of the most common postoperative complications after coronary artery bypass grafting (CABG). Postoperative AF produces a substantial impact on hospital resources with an estimated annual expenditure of over $1 billion. This includes the cost of pharmacological treatment and the cost of the increased length of stay. The incidence of AF is about 30-40% in CABG patients and increases with age of the patient. As the average age of the patient that undergoes CABG surgery is increasing, it is critical to find a way to prevent or reduce the incidence of this complication.

We propose a prospective, randomized, controlled study to determine the role of pulmonary vein isolation by bipolar ablation in the prevention or reduction of postoperative AF. The block- randomization plan will be used to maintain balance of the study and control arms throughout the study.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who require an isolated elective CABG surgery on CPB.
2. Both male and female patients of age 18 years to 90 years.

Exclusion Criteria:

1. Pre existing atrial fibrillation or history of previous atrial fibrillation.
2. Inability to provide informed consent.
3. Pregnant or nursing patients.
4. Reoperative sternotomy
5. Emergency CABG surgery.
Mesh Hernioplasty Of Strangulated Hernias With Intestinal Resection

Primary suture repair increases the risk for recurrence, the fact of benefit of mesh repair in elective situations is documented, and many studies have reported beneficial outcomes of mesh hernioplasty in emergency situations. Still there is controversy of using such grafts in presence of intestinal resection.

Patients with acutely incarcerated hernias (with small intestine contents) who underwent polypropylene mesh hernioplasty were included in this prospective study from June 2005 through Jan. 2011, patients were categorized into 2 groups who required intestinal resection anastomosis (group I)or not (group II).

Eligibility Criteria:
Inclusion Criteria:

* strangulated hernias

Exclusion Criteria:

* above 75, under 18
* recurrent hernia
* peritonitis
* pure omentum contents ASA above 3
The Effect of Nurse Health Education and Follow-up Programme on Sun Protection Behaviors of Children

The aim of the study is to determine the effect of nurse health education and follow up program on sun protection behaviors of children. The study as a randomized controlled group was implemented in February- October 2014 in Turkey. After obtaining the parents' and the children's written consent, data were collected through face-to-face interviews using, the instruments (stages of change, the decisional balance scale, child and parental sun protection behavior form, self-efficacy form) on sun protection based on the transtheoretical model.

Approximately 25% of lifelong sun exposure is formed prior to the age of 18. A significant correlation between exposure to ultraviolet radiation in childhood and skin cancer in adulthood draws attention to the importance of sun protection behaviors to be applied in this period. School-age children are easily reachable to promote preventive health behaviors. The aim of the study is to determine the effect of nurse health education and follow up program on sun protection behaviors of children. The study as a randomized controlled group trial was implemented in February- October 2014. Purposive nonprobability sampling was used to select 25 schools in Izmir Karşıyaka district and research was conducted in two schools where attending the children coming from medium families. Risk assessment for skin cancer was performed by Fitzpatrick classification with 260 children before the study. Out of these children, 144 were found to be risky and were randomized to intervention (n = 40) and control (n = 40) groups according to their age, gender, and skin type. In the survey, the effect size was identified as 0.73 by a 5% error and 80% confidence. After obtaining the parents' and the children's written consent, data were collected through face-to-face interviews using, the instruments (stages of change, the decisional balance scale, child and parental sun protection behavior form, self-efficacy form) on sun protection based on the transtheoretical model. Turkish validity and reliability study of the scale was conducted by Aygün and Ergün (2013). The intervention group was trained about sun protection behaviors in six sessions. Each session lasted 45 minutes. Refresher training was organized on the 15th day, on 1st month 2nd month after the first session. At the beginning and at the end of the program, decisional balance and self-efficacy of children were evaluated. Data were analyzed by frequencies, regression, Wilcoxon signed-rank test, paired-samples t-test, independent samples t-test, Mann-Whitney U test, Friedman's test, and Chi-square test. Written consent was taken from children and their parents, schools, and the local ethics committee.

Eligibility Criteria:
Inclusion Criteria:

* age between 8 and 9
* have the consent of a parent
* Fitzpatrick skin type between 1 and 3

Exclusion Criteria:

* Fitzpatrick skin type between 4 and 6
Pyrotinib Plus Trastuzumab Versus Pertuzumab Plus Trastuzumab

Pyrotinib Plus Trastuzumab Versus Pertuzumab Plus Trastuzumab

This is a retrospective study aiming to explore the efficacy and safety of Pyrotinib Plus Trastuzumab Versus Pertuzumab Plus Trastuzumab in patients with HER2-positive metastatic breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* HER2+ MBC patients scored +3 by immunohistochemical (IHC) analysis or scored +2 and the result of fluorescence in situ hybridization was positive.
* Patients received Pyrotinib(320-400 mg, po, qd) plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w) or Pertuzumab(840mg q3w, and then 420 mg q3w) plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w) for at least one cycle, starting from Jan 2018 to Sep 2022.
* Patients had complete medical records. All data were retrospectively collected from medical records of individual institutions.

Exclusion Criteria:

* Incomplete medical history
A Study to Evaluate Efficacy of YM060 on Diarrhea-predominant Irritable Bowel Syndrome (D-IBS) in Female Patients

A study to verify the superiority of YM060 (ramosetron) to placebo for female patients with diarrhea-predominant irritable bowel syndrome (D-IBS) and to evaluate its safety.


Eligibility Criteria:
Inclusion Criteria:

* Patients meeting the Rome III Diagnostic Criteria
* Loose (mushy) or watery stools within the last 3 months
* Abdominal discomfort and/or pain during their non-menstrual period

Exclusion Criteria:

* Patients with a history of surgical resection of the stomach, small intestine or large intestine
* Patients with a history or current diagnosis of inflammatory bowel disease (Crohn's disease or colitis ulcerative)
* Patients with a history or current diagnosis of colitis ischemic
* Patients with a current diagnosis of enteritis infectious
* Patients with a current diagnosis of hyperthyroidism or hypothyroidism
* Patients who are currently participating in another clinical trial (including a post-marketing clinical study) or those who participated in another clinical trial (including a post-marketing clinical study) within 12 weeks before the study
* Patients with a history or current diagnosis of malignant tumor
* Patients with a history of abuse of drugs or alcohol within 1 year or those who are currently abusing them