cyrilzakka/clinical-trials huggingface dataset:
JASP-1 for Children Recently Diagnosed and Their Parents

To implement and evaluate a patient-and family-centered Juvenile Arthritis Support Program during one year (JASP-1) for children recently diagnosed with JIA and their parents and after 12 months compare satistaction with care and health outcomes with a control group receiving standard care.

Children diagnosed with JIA (n=50) and their parents were offered the opportunity to participate in the JASP-1 from the time of diagnosis and the following year. One year after the JIA diagnosis, the children and/or their parents were invited to answer a study-specific questionnaire comprising 16 questions. The questionnaire assessed their experiences with the information, communication, participation, and emotional support they had received during the first year with JIA. In order to compare outcomes, the questionnaire was answered by both participants in JASP-1 and patients and parents receiving standard care (n=25).

One example of a question is; If you asked questions to the health care professionals, did you get answers that you understood? Response alternatives range from "No, not at all" to "Yes, Completely" ona 5-point Likert scale.

In Swedish Pediatric Rheumatology Quality Register (PedSRQ) information about treatment, disease- and joint activity (registered by Medical doctor), and Patient Reported Outcome Measures (PROM), are measured. The total Child Health Activity Questionnaire (CHAQ-score), as well as active joints and treatment at 12 months was registered in the PedSRQ and analyzed.

The study specific questionnaire measuring patient satisfaction has been developed in collaboration with the Swedish Municipalities and County councils.

Experimental and descriptive analyses will be performed using software for statistical analysis, SPSS. Distributions of responses will be calculated in percentage. Differences in proportions between groups will be determined by performing chi-square tests.

Eligibility Criteria:
Inclusion Criteria:

* Children 1-16 years old
* Diagnosed with JIA at their first visit to the PRC

Exclusion Criteria:

* Children that did not fulfil the criteria for JIA
* Children/parents who could not understand the Swedish language.
Left Bundle Branch Area Pacing Using Conventional Stylet-driven Pacemaker Leads for Cardiac Resynchronization Therapy

The aim of this study proposal is to compare the effectiveness of two distinct pacing modalities for cardiac resynchronization therapy. Our primary hypothesis is that left bundle branch area pacing (LBBAP) using conventional stylet driven pacemaker leads is an effective resynchronization method that yield to at least similar clinical benefits and outcomes when compare to biventricular pacing.

Recently some retrospective or uncontrolled studies were published that compared cardiac resynchronization therapy (CRT) using left bundle branch area pacing (LBBAP) and biventricular pacing (BiV), although with a limited number of patients. Moreover, only one of these studies compared LBBAP + right ventricle stimulation to conventional BiV stimulation prospectively. None of the studies used conventional stylet-driven pacemaker leads for LBBAP. Therefore, the present trial aims to fill-in the gap in the current literature regarding LBBAP for CRT and provide a first randomized head-to-head comparison against CRT.

The aim of this study proposal is to compare the effectiveness of two distinct pacing modalities for cardiac resynchronization therapy. Our primary hypothesis is that left bundle branch area pacing (LBBAP) using conventional stylet driven pacemaker leads is an effective resynchronization method that yields to at least similar clinical benefits and outcomes when compared to biventricular pacing.

The study is a multicentre, randomized trial comparing LBBAP against biventricular pacing. After characterization of the type device implanted (Pacing or Defibrillator), randomization will occur between both groups in a 1:1 ratio. The trial purpose is to demonstrate the efficacy of LBBAP to treat clinical heart failure in-patient indicated to receive a CRT.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or above
* Left Ventricular Ejection Fraction (LVEF) and NYHA meeting one off the previous indications documented with transthoracic echocardiography (TTE) no later than 3 months before randomization.
* New York Heart Association (NYHA) class II-IV
* Baseline left bundle branch block and QRS \&amp;amp;amp;gt;130ms or QRS \&amp;amp;amp;gt;150ms of any morphology or a wide paced QRS duration.

Exclusion Criteria:

* Younger than 18 years old
* Pregnancy
* Any unstable medical condition, life expectancy \&amp;amp;amp;lt; 12 months
* Inability to provide consent or to undergo follow-up
* Narrow QRS duration (≤130ms) or prolonged QRS duration with typical Right Bundle Branch Block (RBBB) morphology on 12 lead ECG and sinus rhythm.
* Significant hypertrophic cardiomyopathy - any septum abnormality contra-indicating LBBAP implantation (according to physician's evaluation)
* Patients who are unable to perform a 6 minute walk test (6MWT) Note: patients should be able to perform a 6 minute walk test, but it is not a requirement to have the test performed before the procedure (e.g. due to inability of planning).
Effect of White Potatoes on Glycemic Response, Satiety and Food Intake in Children

The purpose of the present study is to explore the influence of cooking methods on post-prandial glycaemia and its impact on satiety in children.

Each of the 5 study sessions will be at least 7 days apart. Either meal skipping, or one of three treatments of white potatoes (a) baked (with skin), (b) mashed, (c) fried French fries, or white bread, prepared on the day of testing, will be served to healthy children (9-14 years). Participants will consume the equivalent to 1 medium sized potato (\~280 kcal) or an equivalent amount of calories from white bread. Glycemic response, insulin, incretin hormones (glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic peptide (GIP)), dipeptidyl peptidase 4 (DPP4), and cholecystokinin (CCK) will be measured for 2 h (0, 15, 30, 45, 60, 90 and 120 min) following meal consumption, as well as mood and subjective appetite. An ad libitum test meal will be provided at 120 min to assess food intake suppression.

Eligibility Criteria:
Inclusion Criteria:

* be between 9 and 14 years of age
* be healthy, and have been born at term
* be a native English speaker
* not be taking any medications
* not have allergies to potatoes, rice, or beans.
* normal body weight (between the 5th and 85th BMI percentile for age and gender)

Exclusion Criteria:

* anyone with food sensitivities or allergies to potatoes or potato-products,
* smokers
* diabetic or overweight/obese individuals.
Efficacy and Tolerability of Treatment With Lanthanum Carbonate in Patients With End Stage Renal Disease Receiving Dialysis

The purpose of this study is to assess phosphate reduction and control in patients with End Stage Renal Disease treated with lanthanum carbonate


Eligibility Criteria:
Inclusion Criteria:

* Males and females of childbearing potential agree to take adequate precautions to prevent contraception
* Patients diagnosed with ESRD must have been receiving a stable dialysis regimen for chronic renal failure for the 2 consecutive months prior to enrollment in the study
* Patient requires treatment for hyperphosphataemia

Exclusion Criteria:

* Pregnant or lactating women
* Patients who continue to require treatment with compounds containing calcium, aluminum or magnesium
* Patients with clinically significant uncontrolled concurrent illness, a life-threatening malignancy or current multiple myeloma
* Patients who are HIV+
* Patients with any significant gastrointestinal surgery or disorders
Inspiratory Muscle Training (IMT) in Athletes

The purpose of this study is to determine weather well trained athletes benefit from inspiratory (respiratory) muscle training.

* Subject: The investigators intend to include 40 well trained runners, 18 years or older.
* Design: Following lung function and exercise testing (incremental treadmill test to exhaustion, 5000m run time trial) participants will be randomly assigned to a verum or a control group. The verum group will train with a hand-held, commercially available pressure threshold loading device (POWERbreathe,UK). The control group will perform a sham-training with the same device. After six to eight weeks the the initial tests will be repeated.
* Hypothesis: Inspiratory muscle training enhances performance on submaximal work loads and in the 5000m run time trial by changes in breathing pattern. Maximum oxygen uptake remains unchanged.

Eligibility Criteria:
Inclusion Criteria:

* well trained runners

Exclusion Criteria:

* previous respiratory muscle training
* cardiovascular diseases
* impaired lung function
3 Year Retrospective Analysis of IVF in Comparison With INVOcell

Retrospective chart review of data on the use of traditional IVF and INVOcell IVC collected from clinics using both technologies. The retrospective data will be utilized for a comparison of the two methods.

The following aspects of data will be collected to support the analysis of the two methods

* Procedure details for including oil overlay and incubation time frame
* Characteristics of embryo quality and phase of development and transfer rates
* Clinical pregnancy rate
* Live birth rate Secondary: Data regarding safety
* Adverse events noted by the women that received IVF and INVOcell IVC
* Adverse events noted for the offspring

Eligibility Criteria:
Inclusion Criteria:

* Subjects that have received infertility treatment with either INVOcell IVC or standard IVF during the same timeframe. All subjects treated with the standard of care IVF method during the same timeframe that the center used INVOcell IVC were included in the retrospective data collection.

Exclusion Criteria:

* Not applicable
Effects of Soy Protein on Body Composition and General Health in Healthy Children

The aim of this clinical trial is to assess the effects of daily consumption of soy protein foods on body composition, general health status and dietary intake outcomes in generally healthy children.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is male or female, 8-11 years of age, inclusive.
2. Subject is judged to be in good health on the basis of medical history.
3. Subject is a regular consumer (5 out of 7 d) of breakfast and snacks.
4. Subject has a BMI-for-age within the 75th and 95th percentile (Appendix 3).
5. Subject is willing to follow dietary changes consistent with the Dietary Guidelines for Americans 2010 throughout the study period (Appendix 5).
6. Subject/guardian understands the study procedures and signs forms providing assent/informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigators.

Exclusion Criteria:

1. Subject has a diagnosis of attention deficit disorder, with or without hyperactivity.
2. Subject requires special educational services related to cognitive or attentional disorders, neurologic diseases, and physical disabilities.
3. Subject is a girl who has begun menses.
4. Subject is at Tanner Stage IV or higher, as described by parent/guardian per self-assessment questionnaire (Appendix 2).
5. Subject has a history or presence of a clinically relevant cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, biliary, gastrointestinal, pancreatic, or neurologic disorder.
6. Subject has a known allergy or sensitivity to the study foods.
7. Use of sleep aids within 2 weeks of visit 1 (week -1) and throughout the study.
8. Subject has extreme dietary habits, in the judgment of the Investigator.
9. Subject has used any weight loss supplements, programs, or meal replacement products (within 2 weeks of visit 1, week -1) intended to alter body weight (Appendix 1).
10. Subject has a history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa or binge eating) diagnosed by a health professional.
11. Involvement in any clinical trial within 30 d prior to the screening visit.
12. Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
Fast Versus Slow Tenaculum Placement

The purpose of the study is to investigate whether the speed of tenaculum placement affects perceived patient pain during office transcervical procedures.

IUD insertion and endometrial biopsies are commonly performed in office procedures that use a tenaculum to stabilize the cervix. Patient's often complain that tenaculum placement is one of the most uncomfortable parts of these procedures. Patient's who agree to be in the study will be randomized into one of two groups, either slow tenaculum placement or fast tenaculum placement. Throughout the procedure patient's will be asked to rate the amount of pain they are experiencing using a visual analog scale. The researchers will then compare the two groups. The providers will also rate what they perceived the patient's pain to be with the procedure.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old and older
* Clinic provider plans a transcervical procedure (IUD placement or endometrial biopsy)
* English speaking and able to consent

Exclusion Criteria:

* Incarcerated
* Prior LEEP (loop electrosurgical excision procedure), cryo (cryotherapy) or CKC (cold knife cone) of the cervix
Effects of Silica and Asbestos Fibres on the Efferocytosis Capacities of Macrophages

Evaluation of the efferocytosis capacities of blood Monocyte Derived Macrophages (MDM) from patients with a history of asbestosis or silica exposure and comparison of these capacities with those of MDM from healthy donors.

Patients with a proven history or current exposure will have 4 EDTA tubes drawn, approximately 24mL of fresh whole blood for efferocytosis assessment and :

* 2 x 6mL serum tubes for the assessment of Antinuclear Antibody (ANA) positivity, serum high-mobility group box 1 (HMGB1) and osteopontin for patients exposed to asbestos
* 1 x 6mL serum tube for serum HMGB1 and osteopontin for patients exposed to silica

Eligibility Criteria:
Inclusion Criteria:

* Patient older than 18 Yo
* Addressed to the department of occupational disease
* With a history of asbestosis or silica exposure evaluated by a dedicated questionnaire and a throughout examination of the history of occupations, according to standard procedures for the follow-up of at risk workers.
* Persons who received an oral and written information on the protocol and signed the informed consent form

Exclusion Criteria:

* Pregnant or breastfeeding women
* Subject legally protected (under judicial protection, guardianship), persons deprived of liberty
Effects of Scalp Nerve Block With Ropivacaine on Postoperative Recovery Quality

Patients undergoing elective meningeoma resection surgery will be randomly assigned to one of the following two groups. After anesthesia induction but before skull-pin insertion, one group will receive scalp nerve blocks with 0.5% ropivacaine, whereas the other group will receive scalp nerve blocks with 0.9% saline. The patients' postoperative recovery quality, which is evaluated by KPS score, peri-operative inflammatory responses, and post-operative pain degree will be evaluated and compared between the two groups.

Patients undergoing elective meningeoma resection surgery will be randomly assigned to one of the following two groups. After anesthesia induction but before skull-pin insertion, one group will receive scalp nerve blocks with 0.5% ropivacaine, whereas the other group will receive scalp nerve blocks with 0.9% saline. The patients' KPS scores at 3d after surgery and at discharge, serum levels of TNF-α、IL-6，IL-1β at 24h after surgery, satisfaction score after recovery, and VAS scores at 1, 2, 3 days post-surgery will be evaluated and compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

1. 18-75 years old;
2. BMI 18-28 kg/m2;
3. ASA Physical Status 1-2;
4. Clinical diagnosis of primary Meningeoma and will have elective Meningeoma Resection Surgery;
5. With an estimated surgery time of less than 4h;
6. The incision will be conducted at the frontal, top or the temperal skull.

Exclusion Criteria:

1. A history of previous brain surgery;
2. Severe systemic disease (heart, lung, kidney, or immune system);
3. Nerval or mental disorders;
4. A history of addiction to opioids;
5. Allergic to ropivacaine;
6. Infection at block site or severe systemic infection;
7. Refuse to attend the trial.
Effect of RBT-1 on Reducing the Risk of Post-Operative Complications in Subjects Undergoing Cardiac Surgery

The purpose of this study is to evaluate the effect of RBT-1 on reducing the risk of post-operative complications in subjects undergoing cardiac surgery on cardiopulmonary bypass (CPB). A sub-study will also be conducted to evaluate the pharmacokinetic (PK) profile of a single administration of RBT-1 by means of a popPK approach in subjects scheduled to undergo cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, ≥18 years of age at Screening.
2. Planned to undergo non-emergent CABG and/or cardiac valve surgery requiring CPB; non-emergent surgery must allow for study drug infusion ≥24 but ≤48 hours prior to surgery.
3. If female, subjects must use an effective method of birth control or abstain from sexual relations with a male partner (unless has undergone tubal ligation or hysterectomy or is at least 1 year postmenopausal) for the duration of their study participation.
4. If male, subjects must use an effective method of birth control or abstain from sexual relations with a female partner for the duration of their study participation, unless the subject has had a vasectomy ≥6 months prior to infusion with study drug.
5. Willingness to comply with all study-related procedures and assessments.

Exclusion Criteria:

1. Surgery planned to occur \<24 hours from the start of study drug infusion.
2. Presence of acute organ dysfunction (AKI, acute decompensated heart failure, acute respiratory failure, stroke, etc) as assessed by the Investigator at the time of Screening.
3. Surgery to be performed without CPB.
4. Chronic kidney disease (CKD) requiring dialysis.
5. Hypokalemia and/or hypomagnesemia within 24 hours prior to study drug infusion; electrolytes can be replenished if low.
6. Cardiogenic shock or immediate requirement for inotropes, vasopressors, or other mechanical devices, such as intra-aortic balloon pump (IABP).
7. Known history of cancer within the past 2 years, except for carcinoma in situ of the cervix or breast, early-stage prostate cancer, or adequately treated non-melanoma cancer of the skin.
8. Known or suspected sepsis at time of Screening.
9. Asplenia (anatomic or functional).
10. History of hemochromatosis, iron overload, or porphyria.
11. Known hypersensitivity or previous anaphylaxis to SnPP or FeS.
12. Female subject who is pregnant or breastfeeding.
13. Participation in a study involving an investigational drug or device within 30 days prior to study drug infusion or throughout participation in REN-007.
14. In the opinion of the Investigator, for any reason, the subject is an unsuitable candidate to receive RBT-1.
Early Anatomy Scan for Evaluation of Obese Pregnant Women (EASE-O)

The purpose of this study is to assess the feasibility of ultrasound in the first trimester, assess the completion rate of ultrasounds for fetal anatomy in the first trimester compared to completion rates of ultrasounds for fetal anatomy in the second trimester and to assess the completion rate of the combination of one ultrasound in the first trimester and one in the second trimesters compared to the individual completion rates of both evaluations in obese pregnant women.


Eligibility Criteria:
Inclusion Criteria:

* BMI greater than or equal to 35
* Presented for ultrasound before 14 weeks at The University of Texas Professional Building, Memorial City, Bellaire, or Lyndon-Baines Johnson clinics
* Primary language is English or Spanish
* Consent to an extra transvaginal ultrasound if needed
* Singleton gestation
* No previous anomalies known before consent
* Missed abortion (nonviable pregnancy)

Exclusion Criteria:

* Elective abortion after recruitment
* Missed abortion after first trimester ultrasound
* Did not receive second trimester ultrasound
Identification of L3-L4 Interspace in Parturients

The investigators hypothesize that teaching ultrasound sonoanatomy to identify the L3-L4 interspace will improve resident's long term skill to correctly identify the interspace as compared to palpation alone.

This will be an observational education based study to improve anesthesiology resident's ability to correctly identify the L3-L4 interspace. Residents who agree to participate in the study will be trained using ultrasound to identify the L3-L4 interspace during their rotation on the obstetric anesthesia service. Training will include using the ultrasound to correlate the surface palpation with the underlying structures. This will be supplemented with teaching videos and literature. The training will be performed for the first three weeks of the four week rotation.

After undergoing this training program, during the fourth week of the rotation, the residents will be asked to perform palpation identification of the L3-L4 interspace on parturients. Ultrasound will be used to assess the accuracy of the identified level. These assessments will repeated at six and 12 months to assess whether the skill has been retained.

Eligibility Criteria:
Inclusion Criteria:

* term gestation (at least 38 weeks gestation)

Exclusion Criteria:

* Prior back surgery
* Previously diagnosed skeletal deformities such as scoliosis
* BMI greater than 40
* Height less than 60 inches
* Patient discomfort requiring immediate analgesia
A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Prurigo Nodularis

The purpose of this study is to evaluate the efficacy and safety of INCB054707 in participants with prurigo nodularis over a 16-week double-blind placebo-controlled treatment period, followed by a 24 -week single blind extension period.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of PN for at least 3 months before screening.
* Inadequate response or intolerant to ongoing or prior PN therapy.
* ≥ 20 pruriginous lesions on ≥ 2 different body regions at screening and Day 1.
* Willingness to avoid pregnancy or fathering children
* Further inclusion criteria apply.

Exclusion Criteria:

* Have chronic pruritus due to a condition other than PN; have neuropathic and psychogenic pruritus such as but not limited to notalgia paresthetica, brachioradial pruritus, small fiber neuropathy, skin picking syndrome, or delusional parasitosis.
* Current use of a medication known to cause pruritus.
* Women who are pregnant (or who are considering pregnancy) or lactating.
* Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q-wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.
* Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.
* Participants known to be infected with HIV, Hepatitis B, or Hepatitis C.
* Laboratory values outside of the protocol-defined ranges.
* Further exclusion criteria apply.