cyrilzakka/clinical-trials huggingface dataset:
A Comparison of Technegas and Xenon-133 Planar Lung Imaging in Subjects Referred for Ventilation Scintigraphy

Phase 3 within-subject non-inferiority trial of Technegas ventilation imaging compared to Xenon-133 (Xe-133) ventilation imaging to demonstrate the non-inferiority of Technegas compared to Xe-133 ventilation studies with respect to subject pulmonary ventilatory distribution. Subjects will undergo site-specific standard of care (SOC) Xe-133 imaging per medical needs followed by Technegas ventilation imaging per study protocol.

This is a Phase 3 within-subject non-inferiority trial of Technegas ventilation imaging compared to Xenon-133 (Xe-133) ventilation imaging to demonstrate the non-inferiority of Technegas compared to Xe-133 ventilation studies with respect to subject pulmonary ventilatory distribution. Subjects will undergo site-specific standard of care (SOC) Xe-133 imaging per medical needs followed by Technegas ventilation imaging per study protocol. Primary assessments of efficacy will be based on three blinded readers' assessments of the Technegas and Xe-133 ventilation images in independent reading sessions.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subject at least 18 years of age.
* Subject is a candidate for ventilation imaging.
* Subject must be willing and able to provide informed consent.
* Subject must be stable and able to undergo Xe-133 planar imaging and Technegas planar imaging.
* Subject must be willing and agree to complete study procedures.
* Subject is using adequate birth control, if female and fertile. Adequate birth control is defined as surgical sterilization, hormone contraceptive use or intrauterine device (IUD).
* Female subject of child-bearing potential has a negative urine or serum pregnancy test.
* Subject has had or is scheduled to have a chest X-ray within 24 hours prior to the investigational imaging study.

Exclusion Criteria:

* Subject has been administered any other radiopharmaceutical within a timeframe that might cause interference with study imaging.
* Subject is a pregnant or lactating female.
* Subject has received Technegas in the past.
* Subject has received an investigational drug within 30 days prior to dosing.
* Subject is hemodynamically unstable.
The Blended Care Intervention "Booster" for Youth With Chronic Health Conditions to Increase Fatigue-related Self-efficacy

The goal of this experimental study is to learn if the Booster intervention can be used as an early intervention for persistent fatigue. The aim of the intervention is to prevent more fatigue-related disabilities in young people with chronic illnesses like inflammatory bowel disease, childhood cancer, and juvenile idiopathic arthritis by improving self-confidence in managing fatigue (fatigue-related self-efficacy or FSE).

The main questions this study aims to answer are:

* What is the effect of the Booster intervention on fatigue-related self-efficacy (FSE)?
* What is the effect of the Booster intervention on fatigue levels, school participation, life satisfaction, and perceived health?
* When does improvement in study outcomes happen relative to the Booster intervention?
* What participant characteristics predict change in study outcomes?

Participants will follow the Booster intervention. Booster is a personalised, blended care intervention designed to help young people understand how their thoughts, feelings, and activities impact their fatigue using a smartphone app. The Booster app uses experience sampling methodology (ESM) to track these fluctuations. Based on insights obtained from these data, the participant and their healthcare provider can set personal lifestyle goals, such as increasing physical activity and reducing daytime naps. An earlier version of this intervention, called PROfeel, was effective in reducing severe fatigue. The investigators have now improved the app to also help with setting and achieving personal goals and monitoring daily progress.

The investigators will measure the effect of Booster through daily questionnaires during two phases: Phase A (baseline, before the goal setting between patient and healthcare provider) and Phase B (intervention, starting in the lifestyle change period). The duration of Phase A will be randomised for each participant.


Eligibility Criteria:
Inclusion Criteria:

* Experiencing fatigue for at least 3 months and feeling hindered by it (Pediatric Short Fatigue Questionnaire (pSFQ) score of 15 or higher)
* Diagnosed with a chronic health condition or treated for childhood cancer

Exclusion Criteria:

Regarding other treatments:

* Fatigue fully explained by a somatic or psychiatric diagnosis
* Chronic health condition unstable in the last 3 months (e.g., recent medication changes or cancer relapse)
* Significant functional limitations due to fatigue (e.g., more than 50% school absenteeism)

Regarding feasibility:

* Cognitive impairment with an estimated IQ of below 70
* No smartphone with internet access
* Unable to speak, read, understand, or write Dutch
Laura Mitchell's Relaxation Versus Papworth Exercise in Ashmatic Patient

Asthma is a lung disease that is characterized by airway obstruction that is reversible either spontaneously or with treatment, airway inflammation, and increase airway responsiveness to a variety of stimuli. A wide variety of pharmacological interventions are available nowadays. Apart from that, different Physical therapy techniques increase cardiorespiratory fitness and inspiratory pressure and limit symptoms and restrict medication use. Physical therapy techniques that can be beneficial for an asthmatic patient include Breathing exercises (BE), Inspiratory muscle training (IMT), physical therapy training (PhT), and airway clearance (AC). Laura Mitchell's Relaxation technique and Papworth exercise are advised as an effective nonpharmacological intervention leading to the improvement of symptoms in asthmatic patients. In this study the effects of Laura Mitchell's relaxation technique and Papworth exercise on dyspnea, fatigue, and sleep quality in asthmatic patients will be compared. A randomized clinical trial will be conducted at Laeeque Rafiq Hospital, Lar. Convenient sampling technique will be applied on-patients according to the inclusion criteria. Patients will be allocated through simple random sampling into group A \& group B. Group A will be treated with Laura Mitchell's Relaxation technique and Group B will be treated with Papworth exercise. Treatment evaluation will be done after 2 weeks of intervention through Pulse Oximeter, Asthma fatigue scale, Dyspnea 12 scale and Pittsburgh sleep quality index. Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.


Eligibility Criteria:
Inclusion Criteria:

* Age group of 20-45 years
* Both male and females
* patients diagnosed with asthma according to GINA guidelines, who had not smoked for at least one year

Exclusion Criteria:

* Patients with the history of acute asthmatic attack in last one month.
* Hemodynamically unstable.
* Cough and active hemoptysis
Ultrasound Evaluation of Labor Epidural

To compare the labor epidural analgesic (EA) profiles between landmark insertion EA levels which are congruent and ingruent to ultrasound confirmation in lateral decubitus position.

Epidural analgesia is the mainstream method for labor analgesia. Landmark identification of L3 to L5 spinous process is most commonly applied for determination of epidural insertion. However, the precision of epidural catheter insertion site was affected by physiological and anatomical variations in pregnant women and positions such as sitting or lateral decubitus. Previous study showed the clinical estimation would be ≥ 1 vertebral level higher than the anatomical position determined by ultrasound at least 40% of the time in sitting position among western pregnant women. For asian parturients, epidural analgesia is commonly performed in lateral decubitus position because of smaller stature. In addition, it remains uncertain whether the landmark epidural insertion level congruent or ingruent is associated with different analgesia profiles such as the dosage requirement and the frequncy of adjustment.

Eligibility Criteria:
Inclusion:

1. Normal spontaneous delivery parturients receiving labor epidural analgesia in first stage of labor
2. Using patient-controlled epidural analgesia

Exclusion:

1. who has an accidental epidural puncture
2. who receives epidural insertion by ultrasound identification
3. who uses of magnesium sulfate
A Phase 1 Study To Estimate The Relative Bioavailability And Food Effect Of PF-04620110 In Healthy Adult Subjects

PF 04620110 is an acylCoA:diacylglycerol acyltransferase 1 (DGAT1) inhibitor that is being developed for the treatment of type 2 diabetes mellitus (T2DM). It is anticipated that PF 04620110 will have anti diabetic effects through inhibition of intestinal triglyceride absorption and potentially weight loss. The primary purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of multiple oral formulations of PF 04620110 administered to healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
* Women must be of non childbearing potential.
* Body Mass Index (BMI) of 17.5 to 35.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* A positive urine drug screen.
Effect of Nutritional Counseling Associated With Transcranial Direct-current Stimulation in Binge Eating Reduction

Binge eating disorder is the most prevalent eating disorder, with consequences not only economic but also social. It is related to a set of cognitive alterations related to impulsivity, cognitive function, attention, decision making, emotional control and physiological alterations in the Central nervous system (CNS) in the processing of rewards, mainly in the frontal cortical regions. Psychotherapies are the standard reference treatments, with Cognitive Behavioral Therapy (CBT) being the most indicated nonpharmacological intervention. However, the avoidance rates and the rates of non responders to treatment are significant. In view of this, it is believed that therapeutic approaches aimed at the modulation of the CNS, such as Transcranial direct-current stimulation (tDCS) may have a beneficial effect on the neurobiology of the processes that govern these disorders, thus adding to the effects of CBT and amplifying the therapeutic response.


Eligibility Criteria:
Inclusion Criteria:

* literate
* right - handed individuals
* body mass index ≥ 25 kg / m2
* meet the criteria of the Statistical Diagnostic Manual of Mental Disorders 5th edition (DSM - V) for Binge eating (4 to 7 episodes of binge eating per week).

Exclusion Criteria:

* Pregnancy
* shift workers
* treatment for weight loss in the last 30 days
* bariatric surgery
* formal contraindication for tDCS
A Study of AMG 114 Administered by Subcutaneous Injection for the Treatment of Anemia in Subjects With Non-Myeloid Malignancies Receiving Multicycle Chemotherapy

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of AMG 114 administered subcutaneously for the treatment of chemotherapy induced anemia in subjects receiving multicycle chemotherapy.


Eligibility Criteria:
Inclusion Criteria: Part A: - Non-myeloid malignancy receiving multicycle chemotherapy - Receiving non-platinum containing chemotherapy - At least 6 additional weeks of cyclic cytotoxic chemotherapy planned Part B and Part C: - Non-myeloid malignancy receiving multicycle chemotherapy - At least 12 additional weeks of cyclic cytotoxic chemotherapy planned All Parts: - Chemotherapy induced anemia - Greater than 6 month life expectancy - ECOG 0-2 - Adequate renal and liver function Exclusion Criteria: - Chronic myeloid leukemia, AML, ALL, Burkitt's lymphoma or lymphoblastic lymphoma - History of seizure disorder - Primary hematologic disorder which could cause anemia, other than a non-myeloid malignancy - Unstable angina, congestive heart failure or uncontrolled cardiac arrhythmia - Uncontrolled hypertension - History of pure red cell aplasia - Clinically significant inflammatory disease or active infection - Iron deficiency - ANC less than 0.8 x 10\^9 cells/L
Comparative Study of the Loading Dose Administrated Via Epidural Needle or Epidural Catheter for Labor Analgesia

Epidural anesthesia (EP) is widely used for labor analgesia. Time to onset of adequate pain relief of EP technique for labor analgesia may be 15 to 20 minutes.More rapid injection is often passible through the needle compared to catheter and could enhance the spread of medication within the epidural space.There is lack of research assessing the onset of labor analgesia with a large priming dose of local anesthetic through the epidural needle compared with the epidural catheter.

The epidural analgesia was performed in the left lateral decubitus position at the L3-L4 or L2-L3 interspace using a 18 G Tuohy needle. The epidural space was accessed by the loss of resistance to air or saline (2ml or less) technique.

In the epidural needle group, after identification of epidural space, a dose of 3 ml of 0.1%ropivacaine with 0.3ug/ml sufentanil was given via the epidural needle ,3 minutes later labor analgesia was initiated with 15ml of 0.1 ropivacaine with 0.3ug/ml sufentanil over 30 seconds via the epidural needle, and then the catheter was inserted 3-5cm into the epidural space. In the epidural catheter group, the catheter was inserted 3-5cm into the epidural space after identification of epidural space, a dose of 3 ml of 0.1% ropivacaine with 0.3ug/ml sufentanil was given via the epidural catheter, 3minutes later labor analgesia was initiated with 15ml of 0.1%ropivacaine with 0.3ug/ml sufentanil as the same of group N.

Eligibility Criteria:
Inclusion Criteria:

1. healthy, term (37-42 weeks' gestation),
2. nulliparous women with singleton
3. patients in active labor with a cervical dilation \<5cm who planned labor analgesia

Exclusion Criteria:

1. any contraindication to neuraxial anesthesia,
2. body mass index\>50kg/m2,
3. VAS \<50mm on a 100-mm visual analog pain scales during an active contraction, 4. pregnancy-related diseases (ie, gestational hypertension, gestational diabetes, and preeclampsia),

5. the participants were in the event of an inadvertent dural puncture using the epidural needle, 6.fetal heart abnormity before labor analgesia.
StrataCTX® As a Steroid Sparing Device

The purpose is to determine if StrataCTX® can be used as a steroid sparing agent for the treatment of cutaneous reactions related to, cutaneous T Cell lymphoma (CTCL) and chemotherapy/immunotherapy treatments than the current standard treatment - topical steroids - in people who are receiving treatment for CTCL, or chemotherapy/immunotherapy for solid/hematologic malignancies. Subjects will have CTCL and are being treated with topical steroids, or being treated with chemotherapy/immunotherapy for another condition and have had cutaneous reactions that have warranted initiation of topical steroids.

Topical steroids are the mainstays of treatment for many cutaneous reactions and disorders. Steroids are known to cause many side effects and few effective pharmacologic alternatives exist. Contact dermatitis is observed in 56% of patients with cutaneous T-cell lymphoma (CTCL) being treated with topical mechlorethamine gel. This usually requires chronic treatment with mid-to high-potency steroids. Numerous chemo/immunotherapies are associated with cutaneous reactions including paronychia, hand and foot syndrome, and acneiform rash. Skin toxicity often requires dose reduction of cancer therapies and a variety of skin directed therapies including topical antibiotics and topical steroids. Cutaneous reactions are often the earliest manifestation of acute graft versus host disease. Skin manifestations can be debilitating and treatment usually requires high potency topical steroids. Additional therapies are needed for the treatment of disorders that rely on topical steroids.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Ability to sign informed consent document
* Patient with a diagnosis of CTCL who have contact dermatitis to topical mechlorethamine gel
* Patients with a diagnosis of CTCL who have intractable pruritis
* Patients with a diagnosis of CTCL who rely heavily on topical steroids for symptomatic relief
* Patients on chemo/immunotherapy with drug induced rash

Exclusion Criteria:

* Patients currently undergoing radiotherapy
* Patients currently receiving oral steroids
* Patients who are unable to apply topical medications
Effect of a Plant Rich Diet on in People With Type 2 Diabetes and Obesity

The purpose of this study is to evaluate the effect of a nutrient dense plant rich (NDPR) diet compared to a standard USDA diet on glycemic control, inflammation, and cardiovascular risk in individuals with type 2 diabetes and overweight/obesity.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women ages 18-75
2. Type 2 diabetes mellitus diagnosed \> 6 months prior to screening visit according to American Diabetes Association criteria
3. HBA1c \>7.5% but \< 10%
4. BMI \>25 kg/m2 ; \>23 kg/m2 for Asian subjects but \< 45 kg/m2
5. Stable weight (variation \< 5 kg within 6 months of screening visit)
6. Ability to give informed consent
7. Ability to follow verbal and written instructions in English

Exclusion Criteria:

1. Active cardiac issues: history of myocardial infarction within 3 months of screening visit, unstable angina pectoris, or Class III or Class IV congestive heart failure
2. Persistent uncontrolled hypertension (BP \> 160/100 mmHg on or off antihypertensive medication)
3. Active marijuana or intravenous drug use
4. Recent weight loss (\> 5 kg within 6 months of the screening visit)
5. Inflammatory or irritable bowel disease (Crohn's Disease, Ulcerative Colitis, or IBS)
6. Celiac disease
7. Malignancy treated with chemotherapy within the past 1 year
8. Depression or psychosis requiring hospitalization within 1 year, or use of major antipsychotic or tranquilizer drugs (i.e. benzodiazepines)
9. Renal insufficiency (creatinine clearance \< 30 ml/min)
10. Transaminases \> 2x above the normal range
11. Pregnancy within 6 months of the screening visit
12. Lactation
13. History of surgery for the treatment of obesity (gastric banding, gastric bypass, gastric stapling
14. History of alcohol abuse within the past 5 years
15. Vegetarian/Vegan diet
16. Dairy Allergy/Intolerance
17. Anemia, including iron deficient and megaloblastic
18. Vitamin B12 deficiency
19. Leber's disease
Mechanisms of Exercise-Induced Hypoalgesia

Exercise-Induced Hypoalgesia (EIH) is a lessening of pain sensitivity in response to an acute bout of exercise. Limited research has examined the effects of expectations on EIH during a dynamic resistance training during different intensities. Therefore, the purpose of this study is to examine the effects of positive and negative expectations on EIH.

Individuals who meet the eligibility criteria and consent to participate will attend one testing session that is approximately one hour. Baseline Pressure Pain Threshold will be measured followed by random assignment to one of four study arms.

Eligibility Criteria:
Inclusion Criteria:

* Pain Free

Exclusion Criteria:

* Non-English speaking
* Regular use of prescription pain medications
* Current or history of chronic pain condition
* Currently taking blood-thinning medication
* Any blood clotting disorder, such as hemophilia
* Systemic medical condition known to affect sensation, such as uncontrolled diabetes or neurological conditions
* Not physically ready to exercise without a medical exam as indicated by the Physical Activity Readiness Questionnaire Plus (PAR-Q+)
* Not have had Surgery, injury, or fracture within the past 6 months
Transversus Abdominis Plane Block Versus Local Anesthetic Infiltration for Pain Control in the Abdominal Surgery

Postoperative analgesia is an important part of the anesthetic care. According to the recent studies, multimodal analgesia can provide better analgesia \& patient satisfaction with fewer side effect. For example, combining intravenous, intramuscular or oral analgesics with transversus abdominis plane (TAP) block or local anesthetic (LA) infiltration as the multimodal analgesia, can furnish a more effective pain control after the abdominal surgery.

For abdominal surgery, both local infiltration and TAP block target on relieving somatic pain. Local anesthetic wound infiltration is easy to perform with low risk. As the advancement of ultrasound technology, performing the TAP block also becomes easier, safer and more accurate. But whether LA infiltration or TAP block is better for the multimodal analgesia regimen remains unclear.

This study is to compare the postoperative pain score, opioid consumption, side effects, and quality of recovery between these two analgesic methods in patients undergoing abdominal surgery. The investigators hypothesized that TAP block may be more effective than LA infiltration as a part of the multimodal analgesia, and can improve the recovery after the abdominal surgery.


Eligibility Criteria:
Inclusion Criteria:

* Adult (20\~65y/o)
* American Society of Anesthesiologists (ASA) physical status I\~II
* Patients scheduled for regular abdominal surgery under general anesthesia

Exclusion Criteria:

* ASA physical status ≥ 3
* Allergy to morphine or local anesthetics
* Morphine tolerance
* Drug abuse or addiction
* Bleeding tendency