cyrilzakka/clinical-trials huggingface dataset:
Brief Behavioral Treatment for Anxiety in Young Children

Behaviorally and cognitive-behaviorally based therapeutic techniques (BT; CBT) that incorporate exposure therapy useful for treatment of anxiety disorders among typically developing children. Although a large amount of data demonstrate the effectiveness of of BT and CBT approaches for treating anxious youth, there is a gap in the literature for the effectiveness of these approaches for children under the age of seven. Evidence increasingly suggests that family factors such as accommodation and parenting style contribute significantly to the presence of anxiety symptoms as well as treatment outcomes, particularly in young children. These findings stress the importance of using a treatment approach in which parents are directly involved in education, parent training, and generalization of treatment effects. Therefore, this study aims to evaluate a new treatment program, parent-led behavioral treatment, for children ages 3 to 7 years of age who have a principal anxiety disorder diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Outpatient children between the ages 3-7 years.
* Meets DSM-IV criteria for a primary diagnosis of an anxiety disorder or achieves a minimum score of 12 Pediatric Anxiety Rating Scale (PARS)
* Child has a PPVT IV SS \> 80.
* Patients with co-morbid depression, ADHD, tic disorder or disruptive behavior disorders will be included as long as anxiety is primary (i.e., most impairing/distressing).

Exclusion Criteria:

* • (a) Current clinically significant suicidality or (b) individuals who have engaged in suicidal behaviors within 6 months will be excluded and referred for appropriate clinical intervention.

  * Receiving concurrent psychotherapy, social skills training, or behavioral interventions (e.g., applied behavior analysis). Families will have the option of discontinuing such services to enroll in the study. Those randomized treatment as usual (TAU) will be able to continue or initiate psychosocial interventions (psychotherapy, social skills training, applied behavior analysis, or family therapy) whereas those randomized to PLET will not receive these interventions concurrent with PLET.
  * Any change in established psychotropic medication (e.g., antidepressants, anxioloytics, antipsychotics, stimulants) within 10 weeks before study. Those randomized to TAU may make medication changes following randomization, including starting a medication; those randomized to PLET will remain stable on medications during the study.
  * Absence of language.
  * A formal diagnosis of mental retardation or autism spectrum disorder.
  * Unwillingness of parents to make the commitment to accompany their child for multiple study visits, unwillingness to take part in randomization, inability to attend sessions twice weekly as therapist availability allows, inability to attend assessment visits.
  * Presence of a significant and/or unstable medical illness which might lead to hospitalization during the study.
Effect of Dietary, Lifestyle, and Environmental Factors on Patients With Early-Stage Bladder Cancer

RATIONALE: Learning about the long-term effects of dietary, lifestyle, and environmental factors on the risk of cancer progression and recurrence may help the study of bladder cancer in the future.

PURPOSE: This clinical trial is studying how dietary, lifestyle, and environmental factors affect patients with early-stage bladder cancer.

OBJECTIVES:

* To examine if common and potentially modifiable dietary, lifestyle, and environmental exposures affect the risk of recurrence and progression in bladder cancer.

OUTLINE: This is a multicenter study.

Detailed information will be collected about the patients' lifestyle and their exposure to risk factors associated with bladder cancer using semi-structured questionnaires. A baseline questionnaire will be administered at the time of diagnosis and will collect information about socio-demographics, environmental exposures, medical history, diet, health-related quality of life, and social support.

Further questionnaires will be administered at regular follow-up visits to capture information relating to changes in exposure. A postal questionnaire will be used to collect historical information that may require the patient to check records or consult family or friends. Patients will also be asked to keep a 1-week food, fluid, and micturition diary.

Patients continue to complete questionnaires at 3 months and then annually for up to 5 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

Inclusion criteria:

* Enrolled on parent protocol CRUK-BCPP-2005-01
* Bladder lesion with cystoscopic characteristics compatible with urothelial cancer or transitional cell carcinoma
* Histologically proven urothelial cancer meeting one of the following criteria:

  * Stage Ta (WHO grade 2/3, or grade 1 tumors that are either multifocal or \> 3 cm in size)
  * Stage T1 (any grade)
  * Stage Tis

Exclusion criteria:

* Previous diagnosis of cancer of the urethra, bladder, ureter, or renal pelvis within the 10 years prior to current diagnosis

PATIENT CHARACTERISTICS:

Inclusion criteria:

* Fit for cystoscopy and surgical biopsy/resection

Exclusion criteria:

* HIV infection
* Any condition that, in the opinion of the local investigator, might interfere with the safety of the patient or evaluation of the study objectives

PRIOR CONCURRENT THERAPY:

* Not specified
Glottic View Using Supraglottic Devices in Pediatric Patients

Endotracheal intubation is the gold standard for securing the airway. However, while managing patients with difficult airways, various supraglottic devices have been used as rescue airway devices. The aim of this study is to compare the fiberoptic view through the internal aspect of the i-gel versus the Air-Q LMA in pediatric patients. By examining the fiberoptic view through these two devices, the investigators will determine which device provides a clearer passage to the glottic opening and is therefore the preferred conduit to aid endotracheal intubation in difficult airways.


Eligibility Criteria:
Inclusion Criteria:

* Patients less than 18 years of age who will be receiving an LMA as part of standard of care for their procedure.

Exclusion Criteria:

* None
Arrhythmia Prediction Trial

Patients with Ischaemic and Dilated Cardiomyopathy, face an increased risk for Arrhythmic Sudden Cardiac Death. The purpose of this study is to estimate the performance of Modern Non-Invasive Indices and the performance of Programmed Ventricular Stimulation in Sudden Cardiac Death Prediction.

Sudden Cardiac Death (SCD) threatens survival of Coronary Artery Disease and Dilated Cardiomyopathy patients with Heart Failure. Discovering efficient SCD risk stratification markers is of high importance. In this study, heart failure patients will be risk stratified with indices from the Myocardial substrate (QRS, fragmented QRS, Late potentials, LVEF), indices from the Repolarization status (QT duration, QT rate corrected , QT dispersion, QT/RR, T wave Amplitude Variability, T wave alternans, QT Variability Index), indices from the Autonomic Nervous System function \[ Heart Rate variability, Heart rate Turbulence, Deceleration Capacity (DC) , DC sign of fraction, Beat to Beat DC, Non linear indices of Heart Rate Dynamics\], the Non sustained ventricular tachycardia and Ventricular extrasystolic activity and the Circadian Properties of Heart Rate observed during Ambulatory Monitoring. Furthermore Programmed Ventricular Stimulation will be used. High resolution 30 min ECG recordings will performed for further indices research and development. All the Arrhythmic Risk Stratifiers will be analysed and their performance for Sudden Cardiac Death Prediction and for Total Mortality will be estimated according the follow up.

Eligibility Criteria:
Inclusion Criteria:

* Myocardial Infarction
* Dilated Cardiomyopathy
* Sinus rhythm

Exclusion Criteria:

* Malignant diseases seriously affecting the survival
* Conditions/diseases affecting the Autonomic Nervous System's function
* Dementia
* Alcoholism
* Psychiatric diseases
* Addiction
Postoperative Analgesic Benefit of iPACK Block in the Anterior Cruciate Ligament Reconstruction Surgery

This randomised clinical trial evaluates the analgesia provided by an iPack block associated with an adductor canal block in patients who undergo anterior cruciate ligament reconstruction surgery, compared to an adductor canal block alone. The objective is to prove the superiority of this locoregional anesthesia in terms of analgesia and functional rehabilitation.

The ideal loco-regional anesthesia for anterior cruciate ligament reconstruction ensuring a satisfying analgesia without compromising an early rehabilitation is still undetermined.

Femoral nerve block has been incriminated in a delayed postoperative mobilization whereas the adductor canal block gives an equivalent analgesia for a better preservation of the quadricipital muscular strength.

The iPACK block (infiltration between the popliteal artery and the capsule of the posterior knee) is a recently described technique. Few studies have assessed the iPACK block in ACL reconstruction, and none were randomized.

This randomized single blind clinical trial compares two groups of 45 patients who undergo ACL reconstruction surgery under general anaesthetic : one receives an iPACK block associated with an adductor canal block, and the other only has an adductor canal block.

Pain scores and opioid consumption are collected after surgery in the recovery room, then by telephone interview at 24 and 48 hours post-surgery. Functional rehabilitation is evaluated by scales (KOOS, LYSHOLM and iKDC) at 3, 6 and 9 months after surgery. Adverse effects, due to anesthesia or opioids, are collected from 30 min after loco-regional anesthesia until the second phone call at 48h post-surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* ACL repair surgery under general anesthesia
* Person affiliated or beneficiary of a social security plan
* Free, informed and written consent

Exclusion Criteria:

* Age \< 18 years
* Contraindication to ALR (allergy to local anesthetics, local infection of the puncture site, coagulopathy)
* Pre-existing opiate dependence
* Contraindication to non-steroidal anti-inflammatory drugs
* Pregnant or potentially pregnant women
* Patients under the protection of adults (guardianship, curatorship or safeguard of justice)
* Patients whose cognitive state does not allow evaluation by the scales used
Workplace Wellness: Improving Your Experience at Work

The primary objective of study was to compare affective (i.e., highlighted emotional benefits), instrumental (i.e., highlighted other health benefits), and self-regulation (i.e., demonstrated ways to plan, set goals, etc.) interventions in terms of their ability to motivate less sitting in the workplace. Research of this type is important because people sit for long periods of time at work which adversely affects their health and productivity.

It was hypothesized that the affective and self-regulation groups would sit less than the instrumental and control groups based on evidence indicating that affective attitude (i.e., emotional evaluation of the behavior) and self-regulation techniques tend to predict behavior.


Eligibility Criteria:
Inclusion Criteria:

* From a local workplace in Victoria
* Full-time employee (i.e., greater than 35 hours per week)
* Reported over 5.5 hours of sitting per day at work
* Agreed to attend the 3 intervention sessions

Exclusion Criteria:

* Not from a local workplace in Victoria
* Not a full-time employee (i.e., 35 hours or less per week)
* Reported less than 5.5 hours of sitting per day at work
* Did not agree to attend the 3 intervention sessions
Spermatogonial Stem Cells in Azoospermic Patients: a Comparison Between Obstructive and Non-obstructive Azoospermia

The researchers hypothesized that nonobstructive azoospermia might be associated with a reduction OF SSCs in seminiferous tubules as compared with obstructive azoospermia. Testicular sperm specimens that had been previously extracted from azoospermic patients will be paraffin embedded and stained with anti GPR-125. After antigen retrieval, the sections will be incubated with rabbit anti GPR125 followed by Cy3-conjugated anti rabbit secondary antibodies. Those found to be SSCs will be counted using light microscopy, and compared between patients with obstructive (n=11) and non-obstructive azoospermia (n=9).


Eligibility Criteria:
Inclusion Criteria:

* Azoospermic patients

Exclusion Criteria:

* Patients with sperm cells
PT2385-102 Food Effect Study of PT2385 in Healthy Volunteers

This Phase 1, single-dose study will be conducted in adult female subjects (N = 16) who are in general good health and selected for participation in the study according to the selection criteria. This study will assess the effect of food on the pharmacokinetics of PT2385 Tablets. The study will consist of two periods and will be conducted in a crossover fashion.

Subjects will be randomized in equal numbers to two sequences of meal conditions (fasting and non-fasting). Serial blood samples will be collected for after dose administration in each period. Subjects will be confined at the clinical research for a portion of each period.

Eligibility Criteria:
Inclusion Criteria:

* Female between 18 and 45 years of age;
* If of childbearing potential, willing to practice methods of birth control;
* If of childbearing potential, must be non-pregnant and non-lactating and have a negative serum pregnancy test result prior to enrollment into the trial;
* Has a body mass index (BMI) between 19 and 32 kg/m2;
* Willing and able to give written informed consent for study participation and provide consent for access to medical data;
* Willing and able to cooperate with all aspects of the protocol.

Exclusion Criteria:

* Any vaccination within 30 days before start of this study and throughout the study;
* Use of or need for any systemic drug(s) including vitamins or herbal preparations other than drugs used for contraception, within 30 days before entry into the study or during the study;
* Use of aspirin, non-steroidal anti-inflammatory agents, or acetaminophen within 5 days prior to the ingestion of the study drug;
* Donation or receipt of blood or blood components within the 4 weeks prior to the start of the study;
* Any diagnostic or intervention procedure requiring a contrast agent within the 30 days prior to the start of study participation;
* Abnormal blood pressure or pulse rate;
* Abnormal screening electrocardiogram (ECG);
* Use of tobacco or nicotine-containing products (e.g., cigarettes, cigars, chewing tobacco, snuff, etc.);
* Consumption of alcohol or xanthine-containing products;
* Consumption of grapefruit, star fruit, Seville oranges, or products containing any of these ingredients;
* Receipt of any investigational agent within 30 days;
* A positive history of drug abuse or a positive test result for drug(s) of abuse;
* Female subjects who are planning a pregnancy or are pregnant or lactating.
Effects of a Three-Month Low Calorie Diet Weight Loss Intervention on Knee Replacement Outcomes

Total Knee Replacement (TKR) significantly improves function, pain, and overall quality of life in patients with end-stage arthritis of the knee. However, studies show that obesity increases complications and costs associated with TKR. The American Academy of Orthopaedic Surgeons (AAOS) clinical guidelines recommend that patients with a BMI \> 25kg/m2 lose 5% of their body weight prior to surgery. Consequently, although it is not clear how to patients or providers achieve weight loss in this population, some providers and hospitals decline to perform TKR in patients with obesity. Low Calorie meal replacement diets (LCD) are a feasible way to safely promote short-term weight loss of 8-15% at 3-6 months prior to some elective surgeries.

This is a pilot efficacy study to test whether a short-term program using a 3-month LCD leads to weight loss and improved patient reported and functional outcomes. 75 patients eligible for knee replacement surgery and willing to undergo non-operative weight management treatment at NYU Langone Comprehensive Obesity Center. This study will establish feasibility and weight loss outcomes in preparation for a multicenter effectiveness trial.


Eligibility Criteria:
Inclusion Criteria:

* BMI 35-45 kg/m2
* Any ethnicity
* Able to speak, read, and write in English
* Have knee replacement surgery already planned by the surgeon
* Plan to undergo knee replacement surgery within 3-6 months post LCD intervention
* Willing to commute to NYU Langone Weight Management Clinic at the start of the dietary intervention, midway through, and end of intervention

Exclusion Criteria:

* Uncontrolled type 2 diabetes, defined as HbA1c \> 9%
* If smokes cigarettes, must go through a 6 week cessation program first
* Type 1 diabetes
* Whey protein allergies
* Soy allergies
* Anyone in whom rapid weight loss is not indicated (e.g., ESRD or cirrhosis, metabolic cancer, abnormal 3 times UL liver enzyme labs)
* Current untreated or uncontrolled eating disorder (e.g., binge eating, bulimia)
* Rheumatoid arthritis
* In case a previous knee replacement surgery was done, the participant should wait at least 1 year from previous date of surgery
* Undergoing simultaneous bilateral knee replacement
* Enrolled in a formal weight loss program
* Taking anti-obesity medications
* Coexisting psychotic conditions requiring hospitalization or more intense treatment (e.g., bipolar mood disorder, severe depression)
* Abnormal CBC, and uric acid, must be treated prior to start of intervention
* Higher than 5.5 mU/L or lower than 0.3 mU/L TSH must be treated prior to start of LCD intervention
Tamoxifen for Progressive Transitional Cell Carcinoma Following Previous Chemotherapy Treatment

The major objective of this two-stage phase II study is to determine whether tamoxifen is deserving of further study in metastatic bladder cancer. Tamoxifen is expected to function as a cytostatic (and not cytotoxic) agent, and may produce more disease stability than regression. Sustained stable disease is considered to be clinically important and the more likely event. Hence, 4-month freedom from progression is chosen as the primary end-point instead of response rate. Freedom from progression is defined as the period from start of therapy to the time of objective radiologic progression. A total of 25 subjects will be enrolled, 15 during stage 1 and 10 during stage 2 of a two-stage minimax design phase II study.

Pre-therapy evaluation (within 3 weeks of initiation of therapy):

* History and physical examination (H and P)
* Performance status (PS) assessment
* CBC (complete blood counts)
* CMP (complete metabolic profile)
* Pregnancy test (in women younger than 50)
* Computed tomography (CT) scan of the chest, abdomen and pelvis
* Bone scan if bone pain or raised alkaline phosphatase
* Biopsy (may use previous biopsy specimen)
* Samples of plasma from the routine CBC and CMP will be banked indefinitely for future biomarker studies at the Scott Department of Urology.

Treatment plan: Therapy will be administered as an outpatient. Tamoxifen is administered at 20 mg/day as a single daily oral dose. Clinical assessment of patients by a history and physical examination will be performed every 4 weeks (one cycle). Objective radiological assessment of response will be made every 8 weeks or earlier if clinically indicated. A CT (computerized tomography) scan of the abdomen, pelvis and chest will be performed at baseline and every 2 cycles. A response is confirmed by repeating the scans in 4 weeks. Bone scan is performed if the patient complains of new bone pain or has raised alkaline phosphatase. A radiologist who is blinded to the treatment regimen reads the scans. The RECIST criteria are used to define response. Tamoxifen is continued until progressive disease or intolerable side effects occur.


Eligibility Criteria:
Inclusion Criteria:

* Patients previously diagnosed with bladder cancer who have already received 1-2 systemic therapy regimens (chemotherapy or biological therapy or both) but including at least one chemotherapy regimen.
* Patients who have had the cancer spread to other parts of the body.
* Patients must have adequate liver function.

Exclusion Criteria:

* Patients who have uncontrolled nervous system metastasis
* Patients who are pregnant
* Patients who have had systemic therapies within the past 4 weeks
* Patients who plan to have major surgery within 2 weeks
* Patients who have Grade III/IV heart problems
* Patients who have severe and/or uncontrolled medical disease.
* Patients who might be at high risk for deep vein thrombosis
Smartphone-Delivered Attentional Bias Modification Training in Helping Patients Quit Smoking

This randomized clinical trial studies how well a smartphone-delivered attentional bias modification training works in helping patients quit smoking. Smartphone-delivered attentional bias modification training may help patients quit smoking by reducing the attentional bias (the tendency of one's perception to be affected by their recurring thoughts) towards smoking cues that developed over time as a result of conditioning processes through which smoking cues become important.

PRIMARY OBJECTIVES:

I. To determine the feasibility of smartphone-delivered, in-home attentional bias modification (ABM) to reduce attentional bias (AB) to smoking cues and to reduce smoking behavior in the short- and long-term.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive ABM training over 30 minutes through a smartphone on days 1-14. Patients then receive nicotine patches for up to 8 weeks.

ARM II: Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks.

After completion of study treatment, patients are followed up on days 15, 29, 43, 57, and 72.

Eligibility Criteria:
Inclusion Criteria:

* Smoke an average of 5 or more cigarettes or little cigars per day (CPD) prior to telephone screen
* Produce an expired carbon monoxide (CO) level greater than or equal to 6 parts per million (ppm) or a NicAlert reading of \> 2
* Have a working telephone
* Interested in quitting smoking in the next 30 days
* Fluency in spoken and written English
* Must sign the picture consent form

Exclusion Criteria:

* Taking psychotropic, anticonvulsive, or narcotic medication
* Meet criteria for a current major depressive episode or suicidality
* Have a history of neurological illness or closed head injury
* Report uncorrected vision problems
* Involved in current smoking cessation activity
* Testing positive on a urine drug screen for drugs of abuse/potential abuse
* Women who are pregnant or breastfeeding
* Considered by the investigator to be an unsuitable or unstable candidate (e.g., due to cognitive impairment)
* Shares the same address as a currently enrolled participant
* Unwilling to alter or remove hairstyle, hair extensions, or wig during the clinic visits to allow for correct electroencephalography (EEG) sensor placement
* Reports diagnosis of seizure disorder
* Unwilling to use nicotine replacement therapy (NRT) patches