cyrilzakka/clinical-trials huggingface dataset:
Modeling Between Plasma Concentration and Serotonin Transporter Occupancy Induced by Escitalopram in Obsessive-compulsive Disorder(OCD) Patients

To modeling the pharmacokinetic-pharmacodynamic(PK-PD) simulation with the plasma concentration and the transporter occupancy from OCD patients treated with escitalopram.

To examine the effect of G2677T/A single nucleotide polymorphism(SNP) of ABCB1 gene to the PK-PD modeling in OCD patients treated with escitalopram.

To measure plasma concentration of escitalopram in OCD patients treated with escitalopram.

To measure serotonin transporter occupancy by escitalopram in OCD patients treated with escitalopram.

To genotype G2677T/A SNP of ABCB1 gene in OCD patients treated with escitalopram.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of OCD based on Diagnostic and Statistical Manual(DSM)-IV criteria
* no change of escitalopram dosage in 6 weeks

Exclusion Criteria:

* psychiatric comorbidity other than OCD
* History of head injury, epilepsy, other general medical disorder
Effect of V0251 in Acute Vertigo

Assessment of efficacy and tolerance of a new anti-dizziness drug in acute vertigo.


Eligibility Criteria:
Inclusion Criteria:

* Men or women
* Age 18 to 70 years
* Acute vertigo attack due to vestibular disorder

Exclusion Criteria:

* Signs of brain, brainstem and/or cerebellar dysfunction
* Concomitant central neurological disorder
* Psychogenic vertigo
* Use of ototoxic drugs causing vertigo or dizziness within the last month
* Use of anti-dizziness medications from the onset of symptoms, except if the dosage had been stable for at least 3 months
Music Workshops in the EMPOWER Clinic

Women will be recruited from the EMPOWER clinic when they present for care; they may be given a flyer as part of their clinic entry paperwork, or approached by a study staff member in the waiting area of the clinic. Women who are clients of Sanctuary for Families may find out about the music workshops and the study through Sanctuary for Families staff, who will post flyers in their noticeboards or offices.

This study will use a repeated measures survey design to evaluate the effect of a musical workshop intervention to aid in the management of mood, anxiety, and stress among women enrolled in the EMPOWER clinic for survivors of sex trafficking and sexual violence. Assessment of the feasibility and acceptability of this music intervention will be carried out on participants as they are taught to manage stress and emotions.


Eligibility Criteria:
Inclusion Criteria:

* Women enrolled in the EMPOWER clinic and/or Sanctuary for Families

Exclusion Criteria:

* Unwilling or unable to participate or provide informed consent.
Application of MOSES Technology in BPH

In this study the investigators intend to compare the surgical and functional results of two different modalities of the use of the Holmium laser in prostate enucleation.

In this study the investigators intend to compare the surgical and functional results of two different modalities of the use of the Holmium laser in prostate enucleation using MOSES technology.

Eligibility Criteria:
Inclusion Criteria:

* Prostatic volume between 70-200cc
* Acceptance to participate in the study.

Exclusion Criteria:

* Previous urethra stricture
* Previous prostate surgery
* Neurogenic bladder
* Bladder tumor
* Neurological disease with repercussion in the lower urinary tract.
* Severe psychiatric illness
* Inability of the patient to consent
Venetoclax Registry

Registry Study on Patient Characteristics, Biological Disease Profile and Clinical Course in the Treatment of Acute Myeloid Leukemia With Venetoclax

The aim of this study is to document all patients with AML who are treated with the BCL2 inhibitor Venetoclax outside a clinical trial in all hospitals participating in this registry study in a standardised manner. Data is collected retrospectively and multi-centric. It is neither a therapy study nor is the therapy influenced by this study.

1. Systematic and uniform collection and documentation of all patients treated with the BCL2 inhibitor Venetoclax.
2. Collection and integrative analysis of clinical data of included patients.
3. Mutation analysis of available patient samples and correlation with clinical parameters.

Eligibility Criteria:
Inclusion Criteria:

relapsed/refractory AML

Exclusion Criteria:

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CSD1601: A Study to Evaluate the Exposure to Tar and Nicotine From Two Cigarette Products That Contain a Menthol Capsule in the Filter

This study will evaluate exposure to tar and nicotine from two cigarette products that contain a menthol capsule in the filter, and provide a basis for comparing mouth-level exposure when smokers smoke the two cigarette products.

Subjects will be randomly assigned to the order in which they will smoke two study cigarette products (including one comparator product and one test product). Subjects will smoke each study product exclusively for approximately one week prior to a test visit, with a different product smoked each week over a two-week period. Cigarette butts will be collected the day prior to each test visit for determination of Yield-in-Use (YIU) tar and nicotine levels. Blood samples will be collected at each test visit for determination of blood cotinine levels. Subjects will provide responses to questions during each test visit to assess their cigarette smoking and cigarette butt collection behavior during the preceding day.

Eligibility Criteria:
Inclusion Criteria:

1. Able to read, understand, and willing to sign an Informed Consent Form (ICF) written in English;
2. Generally healthy males and females, 21 years of age or older, at Screening- Enrollment Visit;
3. Self-reports smoking at least seven cigarettes per day and inhaling the smoke;
4. Usual brand of cigarette is one of the brand styles specified;
5. Smoked usual brand for ≥ 3 months;
6. Subject does not intend to delay a decision to quit smoking to participate in the study.
7. Agrees to exclusively smoke the study cigarettes and not smoke or use any other tobacco or nicotine-containing products during the course of the study.
8. Able to read and comprehend English.
9. Able to safely perform the required study procedures, as determined by the Investigator.

Exclusion Criteria:

1. Self-reported history of heart disease, kidney disease, asthma or any other lung disease, diabetes, liver disease, hypertension, or hypercholesterolemia.
2. At risk for heart disease, i.e., obesity (body mass index \[BMI\] ≥ 40 kg/m2), as determined by the Investigator;
3. Females ≥ 35 years of age currently using systemic, estrogen-containing contraception, or hormone replacement therapy;
4. Postponing a decision to quit smoking (defined as planning a quit attempt within 30 days of the Screening-Enrollment Visit) to participate in this study;
5. Use of any medication or substance that aids in smoking cessation, including but not limited to any nicotine-replacement therapy (NRT) (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or lobelia extract within 30 days prior to the Screening-Enrollment Visit;
6. Females who test positive for pregnancy, are pregnant or breastfeeding, or plan to become pregnant during the course of the study;
7. Determined by the Investigator to be inappropriate for the study;
A Comparison of Two Protocol for Maxillary Molar Intrusion Buccal Miniscrew and TPA Versus Vertical Holding Appliance

this study is to compare the dental and skeletal changes caused by the intrusion of maxillary first molars buccal miniscrew and TPA versus vertical holding appliance using lateral cephalometry.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering class I or II with AOB.
* AOB ranged between 3-7 mm assessed from cephalometry.
* Patients with excess in posterior dentoalveolar height according to Burrstone .
* Patients with good oral hygiene and general health.
* Patients with no previous orthodontic treatment.
* Good quality of lateral cephalometry.

Exclusion Criteria:

* Skeletal open bite
* previous orthodontic treatment
The Impact of Oligosaccharides and Bifidobacteria on the Intestinal Microflora of Premature Infants

The purpose of this study is to see whether dietary supplements can change the germs in the intestines of premature infants to be more like those of healthy breast fed term babies.

To determine the optimum dose and optimum dietary supplement to promote a fecal microflora in the formula fed premature infant that is similar to that of the term breast fed infant (a predominance of bifidobacteria). In the initial phase of this trial, 30 premature infants will be randomly assigned to receive increasing doses of one of four dietary supplements: Permeate (a pasteurized human milk concentrate containing human milk oligosaccharides processed by Prolacta), GOS (galacto-oligosaccharides manufactured by Friesland foods), Bifidobacterium infantis or Bifidobacterium animalis. Weekly stool specimens will be examined by PCR to determine content of bifidobacteria and total bacteria. This study is limited to formula fed infants in order to avoid the confounding effects of the human milk oligosaccharides in breast milk. An additional 12 human milk fed infants will be enrolled and will have their diet supplemented with ProlactPlus (a pasteurized human milk concentrate containing humna milk oligosaccharides) or powdered human milk fortifier for comparison

Eligibility Criteria:
Inclusion Criteria:

* Born in or transferred to UCDMC within the first two weeks of life. Birth weight less than 1500 grams. Gestational age less than 33 completed weeks. Exclusively formula fed.

Exclusion Criteria:

* Gastrointestinal or cardiac anomalies.
Quantra QStat in Trauma and Liver Transplant

This is a multi-center prospective, observational study of the Quantra System with the QStat Cartridge in trauma patients and patients undergoing liver transplant.

The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, an ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. The QStat Cartridge was developed to monitor hemostasis in patients that may experience a range of coagulopathies of various etiologies, including fibrinolytic defects. These patients include the trauma and liver transplant populations. The cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding five parameters that depict the functional status of a patient's coagulation system.

This multi-center, prospective, observational pilot study will evaluate the performance of the Quantra System with the QStat Cartridge as compared to conventional viscoelastic testing methods in blood samples obtained from trauma patients and patients undergoing liver transplant.

Eligibility Criteria:
Inclusion Criteria:

* Subject is \> 18 years
* Subject is a trauma patient experiencing traumatic injuries requiring a full trauma team response OR Subject is a patient undergoing liver transplant surgery.
* Subject, or subject's legally authorized representative (LAR), is willing to provide informed consent, either prospectively or by deferred consent, OR Institutional Review Board (IRB)/Ethics Committee (EC) has waived the requirement to obtain informed consent.

Exclusion Criteria:

* Subject is younger than 18 years of age
* Subject is pregnant.
* Subject is incarcerated at the time of the study.
* Subject is currently enrolled in a distinct study that might confound the result of the proposed study
* Subject is affected by a condition that, in the opinion of the surgical team, may pose additional risks.
Combination Chemotherapy Before and After Surgery in Treating Patients With Stomach Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them in different ways may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy before and after surgery in treating patients with high-risk stomach cancer.

OBJECTIVES: I. Evaluate the efficacy and toxicity of neoadjuvant cisplatin/fluorouracil (CDDP/5-FU) followed by surgery followed by adjuvant intraperitoneal floxuridine/leucovorin in patients with high-risk gastric cancer. II. Assess the quality of life and cost-benefit ratio associated with this treatment. III. Evaluate the sensitivity, specificity, and overall staging accuracy of laparoscopy with or without laparoscopic ultrasound in predicting the resectability rate (with and without neoadjuvant CDDP/5-FU), response to chemotherapy, and accuracy when compared to pathologic findings. IV. Correlate the presence of mutated vs. wild-type p53 suppressor oncogenes in endoscopic biopsies and resected tumor specimens with clinical outcome (defined as downstaging, failure pattern, and disease-free and overall survival) in patients treated with and without neoadjuvant CDDP/5-FU.

OUTLINE: The following acronyms are used: CDDP Cisplatin, NSC-119875 CF Leucovorin calcium, NSC-3590 5-FU Fluorouracil, NSC-19893 FUDR Floxuridine, NSC-27640 2-Drug Combination Chemotherapy followed by Surgery followed by Single-Agent Chemotherapy with Drug Modulation. CDDP/5-FU; followed by total or subtotal radical gastrectomy with D2 dissection; followed by FUDR; with CF.

PROJECTED ACCRUAL: A total of 50 patients will be entered over 2-2.5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Microscopically confirmed adenocarcinoma of the stomach or gastroesophageal junction Reviewed by Department of Pathology of participating institution Stage II-IV (T2, N1-2, M0 or T3-4, any N, M0) by physical exam, CT, and laparoscopy Potentially curable by surgery Suspected sites of metastasis proven M0 prior to entry

PATIENT CHARACTERISTICS: Age: Any age Performance status: Karnofsky 60%-100% Hematopoietic: WBC at least 4,000 Platelets at least 150,000 Hepatic: Bilirubin less than 2 mg/dL Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 50 mL/min BUN no greater than 30 mg/dL Cardiovascular: No NYHA class III/IV status No active angina No myocardial infarction within 6 months No significant ventricular arrhythmia requiring medication No clinically significant conduction system abnormality Other: No serious intercurrent infection No nonmalignant medical illness that is uncontrolled or precludes study participation No psychiatric disorder that precludes informed consent No clinically significant auditory impairment No second malignancy within 5 years except: Basal cell skin cancer Carcinoma in situ of the cervix No pregnant or nursing women Negative pregnancy test required of fertile women Effective contraception required of fertile patients

PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy
Memory Encoding Strategies for People With Mild Cognitive Impairments

The purposes of the study are:

* To evaluate the effectiveness of a perceptual-based training program in enhancing cognitive and everyday functioning of older adults with mild cognitive impairment and mild dementia
* To evaluate the effectiveness of a semantic-based training program in enhancing cognitive and everyday functioning of older adults with mild cognitive impairment and mild dementia

People with dementia experience a cognitive decline that affects their functional performance. It has been identified that encoding is less effective in people with dementia. Rehabilitating at the encoding stage is, therefore, essential. A recent systematic review found that effective interventions needed to include training in individually selected memory encoding strategies. These strategies are classified as either perceptual (visual) or semantic (association) memory encoding strategies.

Based on the above literature, the chief investigator (Associate Professor Karen Liu) ran a pilot study on an integrated home and community centre cognitive training programme for 20 elderly people with memory problem using a pre-test and post-test comparison design.

Extending on the positive results, the aim of this project was to investigate the effectiveness of perceptual and semantic encoding strategies (and compare with a control intervention). It also aims to promote the understanding of memory loss and dementia and the need for early intervention for family members of the participants.

Eligibility Criteria:
Selection Criteria:

* are aged 60 or above;
* have no previous psychiatric or memory disorder history or other neurological illness;
* have Mini-mental State Examination score (MMSE) greater than or equal to 21;
* have Clinical Dementia Rating score (CDR) of 0.5 or 1 indicating very mild and mild dementia;
* do not show sign of depression with score below 9 out of 30 in the Geriatric Depression Scale;
* are able to communicate effectively;
* have family member who can participate in the study; and
* voluntarily consent to participate in the study.
Comparison of the Effectiveness of Virtual Reality and Video Assisted Exercises in Pediatric Chronic Kidney Disease.

In this study, we aim to improve respiratory function and balance of decreased muscle strength, decrease fatigue values, improve quality of life, improve inflammation findings and GFR ( Glomerular filtration rate) values in pediatric chronic kidney patients with virtual reality exercise applications.

1.Group - Working group: Virtual reality technology (Nintendo Wii Fit Plus) exercise group 2.Group-Control group: home-based video games will be divided into groups that exercise.

Measurements of functional capacity, muscle strength, quality of life, depression, fatigue and physical activity levels, medical values (pulmonary function test values, inflammation level values, glomerular filtration rate level values) of both groups will be recorded before and after treatment.

In the study group treatment protocol; patients will complete 12 sessions of virtual reality exercise application-Nintendo Wii Fit Plus 30-minute training sessions with strengthening exercises for the lower extremities and upper extremities, aerobic and balance exercises. They will do 5 minutes warm-up exercises before the session and 5 minutes cool-down exercises as well as breathing exercises at the end of the session and will participate in a 50-minute treatment session in total.

In the control group treatment protocol, patients will follow the 30-minute video exercise practices for the lower and upper extremities that are similar to Nintendo Wii Fit exercises for the control group at home two days a week. exercises will complete the 50-minute training session. Apart from exercise sessions, patients will record their activities (walking, cycling, swimming...) in daily life forms with their own pedometers. Thus, changes in physical activity levels will be monitored.

Eligibility Criteria:
Inclusion Criteria:

* 6-18 years of age
* to be chronic kidney disease,
* to have chronic kidney disease at least 6 months
* to have no visual hearing impairment

Exclusion Criteria:

* Attending another exercise program,
* to have severe infection (sepsis, peritonitis)
* Having anorexia or other growth retardation,
* Mental retardation,
* Inadequate communication in Turkish,
* Failure to communicate,
* Cardiomyopathy,
* presence of angina pectoris,
* Standing and walking obstacle
* Presence of orthopedic problem
* Cerebrovascular disease
* Patients with lower limb amputation and not using orthosis-prosthesis,
* patients with metastatic carcinoma will not be included in the study.
A Study to Evaluate ITCA 650 Compared to Glimepiride for the Treatment of Type 2 Diabetes

Phase 3 study to examine treatment with ITCA 650 compared to glimepiride when added to metformin monotherapy in reducing HbA1c in patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* HbA1c between 7.5% - 10.5%
* on metformin monotherapy
* BMI between 25 \& 45 kg/m2

Exclusion Criteria:

* on thiazolidinedione, sulfonylureas, DPP-4, exenatide, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months
* history of pancreatitis
Cardiac Response to Strength Training in Hypertensive Individuals

This study aims to determine the acute effects of high and low-intensity strength training on cardiac autonomic control in hypertensive subjects

The present study aims to determine the cardiovascular response in hypertensive individuals between 30 and 60 years old to one session of high and low intensity strength training.

Participants will undergo a low-intensity strength training including squats, barbell rows, deadlifts and chest presses with a load dynamic of 12 repetitions for 6 sets at an execution speed of less than 55 % of your maximum weight. This is followed by a one-week washout period. Subsequently, high intensity strength training is performed with the same exercises but with a load of 6 repetitions for 6 series at an intensity greater than 80% of the maximum repetition speed. The order of the sessions will be random.

After each session, blood pressure will be recorded for 24 hours using a holter monitor, which will report pressures during both day and night

The results obtained will be determined by the differences in the before and after values. Consequently, the behavior of the following variables: 1) heart rate variability, 2) blood pressure and 3) heart rate will determine the final results of this research.

The entire study will be carried out at the Catholic University of Maule, in its Kinesiology laboratory.

Eligibility Criteria:
Inclusion Criteria:

* Participants exclusively diagnosed with hypertension by a medical professional

Exclusion Criteria:

* Participants with any other chronic medical condition
* Subjects with any upper or lower limb injury that prevents strength training
* Subjects with cardiovascular abnormalities other than hypertension
Burn Outcomes in Young Adult Burn Survivors

As part of Clinical Trials.Gov ID:NCT00253292 a psychometrically sound outcomes instrument was developed to study the outcomes of burn survivors in the 19-30 year old age group. This workgroup has come together to re-examine the data collected during the previous study and determine next steps in understanding the recovery for this population.

This study looks to understand previously collected outcomes scores. Identifying young adult burned patients at risk for poor outcomes remains an under-published field of study. We strive to identify problem areas for this population before they adversely effect their quality of life. How are these 19-30 year olds different from their non-burned counterparts and what interventions can we provide to equalize the balance?

Eligibility Criteria:
Inclusion Criteria:

All burn injured young adults with or without skin grafting. All burned young adults on or after their 18th birthday. Between the ages of 19-30 years. English speaking Present for inpatient or outpatient treatment. -

Exclusion Criteria:

Non-burn skin conditions. Non-English speaking young adults. Young adults less than 19 years of age. Young adults greater than 30 years of age.

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