cyrilzakka/clinical-trials huggingface dataset:
BioFeedBack Breathing Training Influence Cardiac Autonomic Nervous System in Children With Cerebral-Palsy.

The effect of breathing biofeedback training to influence the function of the cardiac autonomic nervous system at rest and in activity in children with cerebral palsy.

Cerebral palsy children suffer from a non-progressive damage of the brain. It is the most common injury that causes physical handicapped in childhood. There are a few researches that investigated the autonomic function in cerebral palsy children. Those researches found hyperactivity of the sympathetic autonomic system, including high resting heart rate compare to their typically developed pears. The recommended treatment for cerebral palsy is activity, muscle strengthening and mobility. The impairment in the autonomic system influences the everyday function and has correlation with secondary morbidity.

As far as we know there are no researches who investigated the following issues.

In this study we would like to:

1. Describe the autonomic cardiac function, Breathing function, motor function and the correlation between them in children with cerebral palsy.
2. Compare the autonomic cardiac function at rest in aerobic test and in diaphragmatic breathing.
3. Test the influence of breathing training on Heart rate variability parameters at rest, in aerobic test right after the breathing training program and one month after, in children with cerebral palsy

Participants:

60 children with cerebral palsy age 6-11 who can walk and understand simple instructions.

Main outcome measures:

Heart rate variability using Polar watch and transmitter RS810CX.

Secondary outcome measures:

1. Lung functioning using Sensormedics Vmax 29 spirometry:Forced Vital Capacity, Forced Expiratory Volume in one,Tidal Volume.
2. Biofeedback
3. Sub maximal aerobic test on treadmill-Modified Naughton Protocol with Polar watch and transmitter.
4. Gross Motor Function Classification System
5. Gross Motor Function Measure
6. Functional Mobility Scale
7. Children Assessment of Participation and Enjoyment
8. Autonomic function questionnaire

Eligibility Criteria:
Inclusion Criteria:

* children with cerebral palsy
* age 6-11 years
* able to walk
* both gender

Exclusion Criteria:

* heart or lung known disease
* can not follow simple commends
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of the ABT-333 Tablet

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of escalating multiple doses of the ABT-333 tablet formulation in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* overall healthy subjects between the ages of 18 to 55 years old;
* if female, subject must be either postmenopausal for at least 2 years or surgically sterile;
* females must have negative results for pregnancy tests performed;
* if male, subject must be surgically sterile or practicing at least 1 of the following methods of birth control:

  * partner(s) using IUD,
  * partner(s) using oral, injected or implanted methods of hormonal contraceptives,
  * subject and/or partner(s) using double-barrier method;
* Body Mass Index is 18 to 29, inclusive

Exclusion Criteria:

* history of significant sensitivity to any drug;
* positive test for HAV IgM, HBsAg, HCV Ab or HIV Ab;
* history of gastrointestinal issues or procedures;
* history of seizures, diabetes or cancer (except basal cell carcinoma);
* clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder;
* use of tobacco or nicotine-containing products with the 6-month period prior to study drug administration;
* donation or loss of 550 mL or more blood volume or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration;
* clinically significant abnormal screening laboratory analyses and ECGs:

  * ALT \> ULN,
  * AST \> ULN,
  * ECG with QTcF\>450 msec in females and \>430 msec in males,
  * or ECG with 2nd or 3rd degree atrioventricular block;
* current enrollment in another clinical study;
* previous enrollment in this study;
* recent (6-month) history of drug/alcohol abuse that could preclude adherence to the protocol;
* pregnant or breastfeeding female;
* requirement for any OTC and/or prescription medication, vitamins and/or herbal supplements on a regular basis or use within the 2-week period prior to the first dose of study drug administration or within 10 half-lives of the respective medication;
* use of known inhibitors or inducers of cytochrome P450 3A or cytochrome P450 2C8 within 1 month prior to study drug administration;
* positive screen for drugs of abuse, alcohol, or cotinine;
* receipt of any drug by injection within 30 days prior to study drug administration;
* receipt of any investigational product within a time period equal to 10 half-lives of the product or a minimum of 6 weeks prior to study drug administration;
* consumption of alcohol within 48 hours prior to study drug administration;
* consumption of grapefruit, grapefruit products, star fruit, or star fruit products within the 72-hour period prior to study drug administration;
* consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-333;
* history of cardiac disease, including family history of long-QT syndrome or unexplained sudden death.
Vaginal Estriol in Multiple Sclerosis

Study to evaluate the efficiency of vaginal estriol, as a treatment for urogenital symptoms in female patients with RRMS. The secondary objective is to evaluate the potential role of vaginal estriol in re-myelination in RRMS patients.

Pilot project to determine the effectiveness of 1 mg transvaginal estriol, as an adjunctive therapy for female MS patients. The goal is to recruit 20 patients from the MS clinic in the neurology department of Texas Tech University Health Sciences Center. This study has been planned in collaboration with reproductive endocrinology, endocrinology, gynecology and basic science. The 1mg transvaginal dose was chosen after careful search of the literature and consultation with collaborators.

Single-group pilot study.

Subjects:

Patients with relapsing remitting MS and urogenital symptoms (frequency, urgency, frequent urinary tract infections, incontinence) will be invited to participate in the study. Enrollment will be during their scheduled clinic appointment. Some candidates (patients of the primary investigator) may be contacted by phone and invited to participate in the study.

The clinical trial will be explained to potential participants in detail, reviewing the objectives and methodology of the study. There will be adequate time allotted to answer any questions or concerns from the potential participants. Those patients interested in participating in the study will be asked to sign the consent form. In order to remind patients about their follow-up visits, lab work, etc., they will be contacted routinely. Participants will be instructed to call in case of questions or concerns.

Patients will be evaluated clinically during their scheduled follow up in which a full neurological exam will be performed during each visit. Patients will be instructed by the primary investigator how to correctly use the vaginal cream. This will be done at their enrolment and reinforced by the principal investigator, during their follow up visits.

Eligibility Criteria:
Inclusion Criteria:

1. Female patients with RRMS over the age of 40 to 65.

   * Being prescribed vaginal estriol to treat their urogenital symptoms such as frequency, urgency, incontinence and frequent urinary tract infections.
   * Patients that had underwent chemical or surgical hysterectomy.
2. Patients will continue their current disease modifying agent for MS during the trial.

Exclusion Criteria:

1. Patients with history of breast cancer, uterine or ovarian cancer.
2. Patients with progressive multiple sclerosis
3. Patients who are unable to undergo an MRI
4. Males
5. Patient is already on vaginal or oral or transdermal estrogens
6. Pregnant or breast-feeding patients
7. Patient taking sex hormones eg testosterone for libido
8. Patients taking DHEA or OTC related products that could influence the hormonal milieu.
9. Patient with prolapse uterus or conditions that would impact on transvaginal absorption of estriol
Postpartum Support: Can we Facilitate the Transition to Motherhood?

We are conducting a study to look interventions that may reduce stress in the postpartum period for first- time mothers. One of these interventions is an educational film that describes the common stressors that first-time parents go through in the early postpartum period. The other is a hotline service that women can call at anytime during the first 3 months postpartum to ask about problems she or the baby may be experiencing.

The postpartum period is a very stressful experience for most mothers. It is generally accepted that women are physically and psychologically stressed during the postpartum. After delivery a woman may have worries about the health of her baby and her own health, as well as the changes in her body, their impact on her sexual life and her relationship with her husband. In addition, she may have financial concerns, concerns about breastfeeding, and be worried about bonding with her baby.

First-time mothers also have to adapt to their new role as mothers and may be worried about their abilities to take care of the baby. This may cause first-time mothers to develop postpartum depression and other emotional problems. First-time mothers can feel overwhelmed, exhausted, and isolated in their new roles.

We are conducting a study to look interventions that may reduce stress in the postpartum period for first- time mothers. One of these interventions is an educational film that describes the common stressors that first-time parents go through in the early postpartum period. The other is a hotline service that women can call at anytime during the first 3 months postpartum to ask about problems she or the baby may be experiencing. The hotline will be answered by a trained midwife.

Women will be recruited from all hospitals in Beirut after delivery and before they leave the hospital. If they agree to participate in the study, they will be randomly assigned to receive the film, the hotline service, both the film and the hotline service, or a CD containing children's songs. Women will be visited at home at 2 - 3 months after delivery by a researcher to complete questionnaires designed to measure stress, depression and anxiety in the postpartum.

Participants will not receive any financial compensation for participating in the study. Although women may benefit from the interventions, we will not know that until we complete the study. However, participation in this study may benefit mothers in the future if we find that the hotline or educational video are useful. There are no risks associated with participation in this study.

Confidentiality of the collected information will be ensured. All information collected will be used for research purposes and will be kept anonymous.

Eligibility Criteria:
Inclusion Criteria:

* Healthy first-time mothers with singleton baby delivered at term with no complications.

Exclusion Criteria:

* Mothers with chronic health problems,
* Pregnancy complications, OR
* Infants with congenital problems or conditions requiring admission to the intensive care nursery.
Menopur And Rekovelle Combination Study

This study proposes to evaluate the effect of adding HP-hMG (Menopur) to follitropin delta in a "mixed protocol" regimen, using an individualized, fixed dose of follitropin delta based on the established algorithm, combined with a variable, adjustable dose of Menopur based on body weight and ovarian reserve.

The initial dose of follitropin delta will be determined at enrolment by the analysis of serum AMH on days 2 to 5 of the menstrual cycle preceding the IVF treatment cycle and body weight in Kg The initial dose of HP-hMG to be added on top of follitropin delta will be determined at enrolment by the total follitropin delta dose and body weight in Kg

Eligibility Criteria:
Inclusion Criteria:

* Women 18 to 40 years of age undergoing their first IVF/ICSI cycle
* Diagnosed with unexplained infertility, tubal infertility, endometriosis stage I/II, or with partners diagnosed with male factor infertility
* Regular menstrual cycles of 24-35 days
* Presence of both ovaries
* Early follicular phase FSH serum concentration \<10 IU/L measured between Day 2 to Day 5 of menstrual cycle within the previous 12 months
* Ejaculated sperm (fresh or frozen) for insemination

Exclusion Criteria:

* Inability to consent
* Endometriosis stage III and IV
* High risk of OHSS (AMH ≥ 35 pmol/L)
* History of recurrent miscarriages defined as ≥ 3 consecutive losses
* Women undergoing egg donation
* Women participating in any other research project
* Use of hormonal preparations (except for thyroid medication) during the last menstrual cycle
* Hypersensitivity to follitropin delta and/or HP-hMG
The STOVITA Study - Bioefficacy of Beta-Carotene in Oil and in a Mixed Diet in Ileostomy Patients

A controlled dietary intervention study will be carried out based on the stable isotope method the investigators have developed to quantify both the absorption of beta-carotene and its bioconversion to retinol in oil and in a mixed diet. For 4 weeks the participants will consume 2 capsules/day, 7 days/week with each capsule containing 100-mg \[13C10\] beta-carotene and 100-mg \[13C10\] retinyl palmitate. For two weeks they will consume a diet with high levels of beta-carotene in vegetables and fruits and for the other 2 weeks they will consume a diet with low levels of beta-carotene in vegetables and fruits supplemented with an extra amount of beta-carotene in oil. Samples of blood and faeces will be taken. The study hypothesis is that the absorption of beta-carotene in oil in comparison with the absorption of beta-carotene in a mixed diet differs by a factor of 3 to 6. The investigators want to measure the influence of the food matrix of vegetables and fruits on the absorption of beta-carotene in ileostomy patients on a western diet.


Eligibility Criteria:
Inclusion Criteria:

* Men and women between 18 and 75 years old
* Body mass index (BMI) between 18 and 30 kg/m2
* Willing to consume the controlled diet and not consume other food items
* Willing to consume the capsules every day
* Having a functional ileostomy (output \<2 L/d)
* Relatively good medical, nutritional and health status

Exclusion Criteria:

* Diseases which disturb normal digestion and absorption
* Use of (oral) drugs suspected of interfering with fat-soluble vitamin absorption
* Excessive alcohol consumption (\>30 g/d)
* Consumption of vitamin or carotenoid supplements 6 weeks before and during the study
* Not too low or high levels of serum beta-carotene and retinol
* Normal hemoglobin, hemocytometry, creatinine, ALAT, alkaline phosphatase, and cholesterol blood values (compared with laboratory references)
* Pregnancy
CML Pediatric ITK Response According to Molecular Identification at Diagnosis

Treatment of chronic myeloid leukemia (CML) has been revolutionized by tyrosine kinase inhibitor (TKI). Nevertheless, case of failure and suboptimal response are still observed even in children. Pediatric CML is a rare disease and differs from adult in terms of disease presentation and treatment response underlying a likely different CML biology. Molecular mechanisms that induce resistance to TKI are still poorly characterized except mutations in the tyrosine kinase domain of BCR::ABL1. We propose to search for a molecular signature to predict the response to TKI in the pediatric population.

Commonly mutated genes associated with myeloid malignancies have been described in acceleration phase and blastic phase but also at diagnostic in adult chronic phase-CML (CP-CML). The impact of these mutations on treatment response is still debated but several studies observed a worse outcome in adult patients with some mutations. In children only one study explored the molecular status of 30 genes in 21 children and young adults. They found a higher proportion of ASXL1 mutations in children than in adult They did not observed any significant difference in overall survival of ASXL1 mutated versus non-mutated patients but probably due the small size of the cohort. We propose here, to investigate retrospectively on DNA at diagnosis of 88 CP-CML children the mutation status of 64 genes by next generation sequencing and to see if there is an association with the response to TKI treatment. We will complete the molecular signature by analyzing the differentially genetic expression profile by RNA-seq on peripheral blood RNA of 8 patients with CCR at 12 months (and/or a BCR ::ABL1 IS ≤1%IS) and 8 patients with no CCR at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Age at diagnosis less than or equal to 18 years
* Presence of a Philadelphia chromosome detected by cytogenetic analysis (conventional karyotype or Fluorescence In Situ Hybridization (FISH)) and a BCR ::ABL1 transcript e13a2 ou e14a2
* Diagnosis in chronic phase according to the European Leukemia Net (ELN) criteria
* First-line treatment with TKIs
* Possible pre-treatment with hydroxyurea
* DNA available at diagnosis
* RNA available for a sub-group patients (8 responders vs 8 no responders)

Exclusion Criteria:

* Age at diagnosis more than 18 years
* Diagnosis in accelerated phase or blastic phase
* First line treatment other than TKI
Impact of Lower Urinary Tract Dysfunction on Clinical Manifestation in Patients With Stroke

The course of post-stroke bladder problems and their relation with functional, mental status and quality of life: A six-month prospective, multicenter study

Lower urinary tract symptoms is a broad term of subjective urinary symptoms such as nocturia, urgency, urinary incontinence, and frequency of voiding, defined by the International Continence Society. Several disorders and conditions affecting the nervous system that controls the lower urinary system can result in neurogenic lower urinary tract dysfunction (LUTD). Stroke is one of these conditions. The literature review reveals that there is insufficient data regarding the course of LUTD symptoms other than urinary incontinence in stroke patients, and their relation with functional and mental status. The aim of this prospective, multi-center study was to determine the frequency and course of post-stroke LUTD from early term up to a period of six months, and to investigate the relation of LUTD with functional and mental status and quality of life in stroke patients.

This study was designed as a prospective study and included 70 stroke patients enrolled by the Neurogenic Bladder Study Group from five different centers across Turkey.

The demographic (age, sex, education, marital status and occupation) and clinical characteristics (side of the stroke, cause of the stroke, stroke localization and anticholinergic medication use) of the patients were obtained from the patient files and through face-to-face interviews. In addition, patients were questioned on the post-stroke 1st, 3rd, and 6th months in terms of bladder drainage methods (normal spontaneous urination, use of adjunct maneuvers such as crede, valsalva and tapping, presence of overflow, clean intermittent catheterization use, permanent catheter use) after stroke.

The patients were questioned using the Danish Prostatic Symptom Score (DAN-PSS), and evaluated using the Brunnstrom motor staging (hand, upper and lower extremities), modified Barthel index, incontinence quality of life questionnaire (I-QOL), and the Mini-Mental Test (MMT) on the 1st, 3rd and 6th months.

Eligibility Criteria:
Inclusion criteria were as follows: 1) a recent (one month) stroke in medically stable patients and 2) being older than 18 years.

Exclusion criteria were as follows:eria: 1) presence of a history of a prior cerebrovascular disease, 2) presence of a concurrent neurological disorder, 3) presence of an acute systemic disorder or a concomitant disease that could affect urination problems, 4) history of urinary system problems before stroke, and 5) patients incapable of answering questions due to any reason.
Quality Improvement Strategies to Increase Human Papillomavirus (HPV) Vaccination in Integrated Healthcare Delivery Systems

HPV vaccination coverage is at lower levels than the national goal. This study will evaluate the effectiveness of quality improvement strategies for increasing HPV vaccination coverage among adolescent within the context of large integrated health care delivery systems.

The University of North Carolina (UNC) will evaluate the impact of a quality improvement (QI) model for increasing HPV vaccination coverage among adolescents in primary care settings. UNC will partner with the American Cancer Society (ACS) to evaluate the effectiveness of their Vaccinate Adolescents against Cancer (VACs) model for HPV vaccine QI within the context of integrated healthcare delivery systems (IDSs). The VACs model includes the development of a QI action plan and a QI team. The QI team is made up of health care providers from participating clinics within the IDSs. The team then helps implement specific QI activities in participating primary care clinics. The model also includes vaccination coverage assessments in participating clinics at multiple time points to assess the impact of QI activities. Specific QI activities that will be offered to participating clinics will be chosen from a menu of options that will include the Center for Disease Control and Prevention's AFIX model and physician-to-physician engagement. AFIX (Assessment, Feedback, Incentives and eXchange) consists of brief quality improvement consultations that immunization specialists from state health departments deliver to vaccine providers in primary care settings. Using immunization registry data, the specialist evaluates the clinic's vaccination coverage and delivers education on best practices to improve coverage. Physician-to-physician (P2P) engagement consists of an in-depth training about how to make strong and effective HPV vaccination recommendations to primary care providers. The investigators will compare changes in HPV vaccination coverage between the quality improvement arm or wait list control arm.

Eligibility Criteria:
Inclusion Criteria:

* Integrated healthcare delivery systems headquartered in New York State or Wisconsin with at least 4 pediatric or internal medicine practices within the system.
* All clinics within the integrated healthcare delivery system must participate in the state immunization registry.

Exclusion Criteria:

* Integrated healthcare delivery systems headquartered outside of New York State or Wisconsin.