cyrilzakka/clinical-trials huggingface dataset:
Study of Nasal Airflow Pressure Optimization to Resolve Excessive Snoring

This is a prospective, interventional, study in which patients with a history of habitual snoring to determine whether low pressure nasal continuous airway pressure can reduce the frequency, duration or intensity of snoring in subjects with mild to moderate snoring who do not have Obstructive Sleep Apnea (OSA).

In this a prospective, interventional, study, each patient will be studied four times. Subjects without OSA will undergo an initial observational control study to establish the presence of snoring (session 1); a single CPAP titration night to determine the minimally effective CPAP level (session 2) to alleviate snoring; a subsequent full night of CPAP treatment at this CPAP level (CPAP not to exceed 6 cm H2O) using the Cloud9™ low-pressure CPAP device (session 3); and a final control night of study conducted off CPAP to assess whether the patient's snoring remained stable over time (session 4). In this study, each subject shall serve as his/her own control.

Eligibility Criteria:
Inclusion Criteria:

* Subject is \> 18 years of age.
* Subject is willing and able to provide written Informed Consent using a Patient Information and Consent form that has been reviewed and approved by a governing Institutional Review Board (IRB).
* Subject has a history of habitual snoring (almost every night or every night for at least 30% of the night) as determined by the subject or a bed-partner.
* Subject has been pre-screened and demonstrates no excess daytime sleepiness on an Epworth Questionnaire (an assessment of daytime sleepiness; high number = greater sleepiness) score of less than 11, no history of witnessed apneas or nocturnal gasping/choking episodes and a body mass index (BMI) ≤ 35.

Inclusion Criteria for treatment trials (Nights 2 and 3):

* Subject meets Inclusion Criteria for the Baseline Trial (criteria a-d above)
* The subject has snoring intensity that exceeds 40 dBA during ≥30% of the respiratory efforts during sleep time on the baseline study night.

Exclusion Criteria:

* Subject has been diagnosed with COPD (Chronic Obstructive Pulmonary Disease), such as asthma, emphysema or chronic bronchitis.
* Subject has a history of heart disease, heart attack or stroke.
* Subject has uncontrolled or poorly controlled hypertension.
* Subject has been diagnosed with Obstructive Sleep Apnea (OSA), defined as an apnea hypopnea index (AHI) ≥ 5/hr in the presence of excessive sleepiness (an Epworth score ≥ 11) or AHI ≥15/hr when there is no evidence of excessive daytime sleepiness (an Epworth score ≤ 10).
* Subject is currently participating in another clinical study for which follow-up is ongoing.
Effects of Intensity-matched Agility and Cycling Exercise Training on PD Patients' Clinical Symptoms, Posture, and Mobility

Determine the short-term and lasting effects of intensity-matched exercise programs on level 2-3 PD patients' clinical symptoms, postural control, and mobility.

Hypothesis

1. The inclusion of a Borg-scale/heart-rate matched active control group will allow us to test the idea that, in addition to a fitness element, the reflexive movements that chellenge PD patients' sensorimotor system will improve patients' clinical symptoms, posture, and mobility more than fitness training and that such lasting effects will be superior in the agility compared with the fitness-control group. This hypothesis emered from the idea that the favorable results in the currently under review paper may be in part due to a simple conditioning effect instead of a specific motor learning effect caused by the xbox training.
2. If feasible, i.e., if there is a lerge enough pool of patients to randomize, a balance training group will be also added to test the idea that the reflexive actions evoked by the agility program by xbox exergaming still produce superior adaptations vs. the balance group because xbox forces patients to rapidly and reflexively execute movements (respond to cues, prompts), while balance training allows patients to stop, go, stop, and go and disrupt the continous execution of linked movements. The disruptions of movement chains could arise from small losses of balance on the unstabel surfaces, need for patients to re-initiate every movement element of a sequence, planning each movement element. It is not clear yet how it woul be possible to match all three intervention groups on Borg/heart rate intensity.

Agility: Xbox based high intensity program, as detailed in the submitted manuscript. Borg scale after after each exercise block is recorded. Heart rate continuosly measured. These data are used to set intensity in the fitness group.

Fitness: A stationary bicycle ergometer program that includes visual stimulation in the form of watching nature programs and movies to account for visual stimulus in Agility group. Mean heart rate and Borg scale readings from Agility group will form the target intensity.

Control: No-exercise, measurment-only control group.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease,
* Hoenh Yahr scale of 2-3,
* instability problem,

Exclusion Criteria:

• Severe heart problems, severe demeanor, alcoholism, drug problems,
Prevalence of BRCA in Patients With Ovarian Cancer

The aim of this prospective registration and translational research study is to evaluate the praevalence of BRCA regarding germline and somatic mutations.

Explorative analysis will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Female ovarian cancer patients aged \>= 18 years.
* Women with first diagnosis of epithelial ovarian cancer OR women diagnosed with platinum-sensitive recurrent ovarian cancer.
* Multiple platinum based prior therapies are allowed.

Exclusion Criteria:

* Non-epithelial ovarian malignancy.
* Platinum-resistant or refractory disease.
* Paraffin embedded tumor samples not available.
Antioxidants vs. Ovarian Bio-stimulation Therapy to Rescue the Ovarian Reserve

Two group of patients were selected. Group 1 represents 46 patients that received ovarian-biostimulation monthly for three months. Group 2 represents 32 patients that received antioxidant therapy daily for 3 months. Results are noted and analysed.

Both groups represent patients with procedures already ongoing, and with diagnosed poor or depleted ovarian reserve.

The analysis has been made to compare the efficacy of both procedures.

The bioestimulation group received a blood rich platelet therapy monthly for three months, with a technique developed by the laboratory. The second group of antioxidants received a combination of antioxidants monthly for three months. Both groups were compared to assess the results in terms of ovarian response (number of astral follicles, AMH levels, FSH, LH), and egg quality, embryo development, implantation rate, and successful pregnancy with healthy live birth.

Eligibility Criteria:
Inclusion Criteria:

* Age between 38 and 46 years
* FSH\> 12 mIU
* Estradiol \> 100 pg/ml
* AMH \< 0.8 ng/mL

Exclusion Criteria:

* Pelvic inflammatory syndrome
* vaginal pathologies
* known history of hyperandrogenism
* diagnosed platelet disorders as adhesion
* aggregation
* disorder of thromboxane synthesis.
Validation of a New Optimized Nighttime Providence Brace for Personalized Treatment of Adolescent Idiopathic Scoliosis

Adolescent Idiopathic Scoliosis affects 3-4% of the Canadian population, of which about 10% will need a brace treatment during pubertal growth spurt. Our team has developed an innovative conception method for brace design by optimizing for the immediate in-brace correction. The model is customized to each patient. In this project, the investigators will evaluate the effectiveness of this platform's customized treatment and validate its clinical application.


Eligibility Criteria:
Inclusion Criteria:

* AIS diagnosis
* Risser 0-2
* Primary curve angles 20 degrees - 40 degrees
* If female, either premenarchal or less than 18 months postmenarchal.

Exclusion Criteria:

* Patients with a pre-existing cardiovascular condition
* Patients with a symptom of a neurological disorder
* Patients with any other disorder of the musculoskeletal system affecting the lower limbs
* Pregnancy
Efficacy of Providing Eggs as an Early Complementary Food to Promote Child Growth

This study will investigate the efficacy of providing one chicken egg per day for a period of 6 months, beginning at the age of 6 to \<9 months on the growth, motor development, micronutrient, and morbidity status of infants from a low socioeconomic community in South Africa.

The nutritional benefit of eggs, in particular chicken eggs is well documented. However, there is paucity of evidence regarding including eggs, in particular chicken eggs during the early complementary feeding phase to enhance child growth and development. Thus, this study seeks to determine and to provide evidence on the effectiveness of including chicken eggs as an early complementary food to enhance early child growth and development. This randomised controlled trial will contribute towards building a strong evidence for the promotion and use of eggs as a healthy and nutritious early complementary food, and can be used to inform future programming regarding infant and young child feeding in low- and middle-income countries.

This is a randomised controlled trial with a parallel design (2 groups). Five hundred infants aged 6 to \<9 months will be included. Infants with egg allergy or sensitization will be excluded. Data will be collected in three months' interval for six months. At baseline, body measurements of mother and infant will be taken; infant's dietary intake using 24-hour recall methods; breastfeeding and complementary feeding practices; infant and maternal allergy and maternal depression with structured questionnaires. Morbidity symptoms and compliance will be recorded daily and followed up weekly. Developmental milestones will be assessed weekly using Pictorial Gross Motor Milestone Chart. Household food security will be assessed. Capillary blood will be collected by means of finger and/or heal prick. This will be a community driven project. Data will be analysed according to intention to treat.

Eligibility Criteria:
Inclusion Criteria:

* Resident in the study municipality; Infants aged 6 to \<9 months

Exclusion Criteria:

* Severe obvious congenital abnormalities such as cleft lip and spina bifida; Severe anaemia (haemoglobin \<70 g/L); Severe acute malnutrition (weight-for-length z-score \< -3); Plans to move out of the study area in the next nine months; Known allergies/intolerances to eggs; Infants receiving special nutritional supplements as part of feeding programmes; Not been born as a singleton; Mother/legal guardian below 18 years old at the start of the study
Effect of Educational Intervention in Mothers for Prevention of Caries in Their Children

The purpose of this study is to determine the effect of an educational intervention on mothers knowledge, attitudes and practices for preventing childhood caries.

Health education is being used as a key preventive tool in the prevention of chronic diseases such as heart disease, cancer, obesity, mental illness, neurological disturbances as well as dental diseases.

Amongst the dental diseases, dental caries is a high prevalence chronic childhood disease having long term growth and developmental implications . A number of educational programs have been utilized to decrease its prevalence especially in disadvantaged communities.

Dental caries is a complex interplay of a number of risk factors such as demographic (socioeconomic status, race, etc.) behavioral, dietary and cultural factors. Among the dietary intake, the most significant risk factor has been a high frequency intake of sugary foods and drinks.Patterns of sugar intake are established early in life and sugar intake increases in the first two years of life.

Early feeding practices and lack of oral hygiene maintenance have been identified as risk factors for caries in subsequent years. Maternal education can prove to be protective against dental caries by way of child's dietary practices.

Research has also indicated a reduction in prevalence of caries in children whose parents were previously participants of an oral health educational program.

Educating mothers about oral hygiene and feeding practices before the child transitions from exclusive milk diet to a variety of foods in an important time to exert a positive influence on dietary intake of child and overall oral health.

Eligibility Criteria:
Inclusion Criteria:

* Mothers of 9-15 months old attending the vaccination clinic who consented to be a part of the study

Exclusion Criteria:

* Mothers with severely ill children or children suffering from a co-morbid disease.
Postoperative Progression of the Disease Following Extensive Versus Limited Mesenteric Excision for Crohn's Disease

The study evaluates whether there is a reduction in the rate of postoperative progression of the disease following extensive mesenteric excision (EME), when compared to that of limited mesenteric excision (LME), in patients undergoing ileocolic resection for Crohn's disease. Half of participants will receive EME, while the other half will receive LME.

EME and LME are the two surgical procedures which are commonly used in the treatment of Crohn's disease. However, the areas of the mesenteric tissue resected are different.

EME means that the mesentery is resected avoiding the root region, i.e. 1 cm from the root of ileocolic artery and vein.

LME represents that the mesentery is retained, i.e. "Close shave" or 3 cm from the border of bowel (using whatever approach - clips, or haemostatic vessel sealing device).

Eligibility Criteria:
Inclusion Criteria:

* Patients with Crohn's disease limited to the distal ileum and/or right colon receiving their index ileocolonic resection
* Patients with a documented history of Crohn's disease based on endoscopic, radiological, or histological criteria

Exclusion Criteria:

* Pregnancy or willingness to become pregnant in the following year
* Previous ileocolic resection history
* Patients having Crohn's disease lesion at a gastrointestinal site other than the terminal ileum cecum, or right colon
* Patients having an internal fistula which required resection of another segment of bowel
Potato Fiber and Gastrointestinal Function: Phase 3

The primary physiological impacts of fiber intake include the gastrointestinal effects of stool bulking, increased stool frequency and decreased gastrointestinal transit time (GTT). Fermentation of resistant starches by microbiota increases bacterial numbers, which increases fecal bulk and may impact frequency and transit time. The purpose of this study is to determine the effects of resistant potato starches (potato fiber) on stool frequency, transit time and microbiota in healthy individuals.

Potato fiber (PF-RS, PF-RO1 and PF-RO2), supplemented in the diet of healthy individuals (n=60; 20 per group) and providing 30 g per day of fiber, will result in a significant changes in gastrointestinal function and microbiota profile.

Objectives:

1. To determine the effect of potato fibers on stool frequency, gastrointestinal transit time and gastrointestinal symptoms.
2. To determine the effect of potato fibers on microbial diversity in healthy individuals.

Eligibility Criteria:
Inclusion Criteria:

* must be between the ages of 18 and 65.
* must be willing to complete daily questionnaires.
* must be willing to provide a social security number to receive study payment. Note: the subject can still participate if unwilling to provide SS#, but no financial reimbursement can be provided.
* must have internet access for the duration of the study
* must have usual fiber intake of \<20 g/d based on Food Frequency Questionnaire such as the Block Fruit/Vegetable/Fiber Screener
* must be willing to consume kool-aid everyday for 2 periods of 14 days
* must be willing to provide stool samples

Exclusion Criteria:

* must not have a physician-diagnosed gastrointestinal disease or condition (such as ulcerative colitis, Crohn's disease, gastroparesis, cancer, peptic ulcer disease, Celiac disease, short bowel disease, ileostomy, colostomy other than GERD, constipation, diverticular disease)
* must not have a food allergy
* must not take dietary supplements (prebiotic and fiber supplements)
Effects of Diet and Exercise on Circadian Glycemia

Specific aims of the study are:

1. to evaluate whether a 24-h exposure to a 25%-carbohydrate diet will reduce postprandial glycemia to the same extent in the evening (19 h) as in the morning (7 h),. and
2. to determine whether one hour of post-meal moderate intensity exercise (at 50% of maximal effort) will further reduce postprandial glycemia.

The outcome measures are: plasma concentrations of glucose, insulin, glucose-dependent-insulinotropic peptide (GIP), leptin, and the ketone body beta-hydroxybutyrate.

The two hypotheses in this study are:

1. A 24-h exposure to a 25%-carbohydrate diet will reduce postprandial glycemia to the same extent in the evening (19 h) as in the morning (7 h), and
2. One hour of moderate-intensity exercise (at 50% of maximal effort) will further reduce postprandial glycemia to the same extent in the evening (19 h) as in the morning (7 h).

Eight postmenopausal subjects (age 58.5 years, BMI 25.6 kg/m2) participated in 4 24-h long crossover trials, two terminating at 7h and the other 2 at 19h. At each circadian time one trial required 60 minutes of moderate-intensity exercise (50% of maximal effort), and the other two involved no exercise.

Three 25%-carbohydrate meals prepared by the Michigan Clinical Research Unit (MCRU) kitchen, were eaten at subjects' home, and the fourth was eaten 20 minutes after subjects' arrival at MCRU at either 19 h or 7 h. Blood was collected from antecubital catheter at 10-minute intervals until 23:20 h or 11:20 h, respectively.Plasma was treated with protease inhibitor to preserve GIP, frozen at -80o C until glucose measurements by glucose oxidase, hormone measurements by chemiluminescence, and ketone measurements by Abbott meter strips.

Exercise intensity was determined before the exercise trials on a treadmill from oxygen consumption (VO2) and carbon dioxide production (VCO2) by subjects walking on a treadmill at 3 mph with the treadmill slope increased by 2% every 3 minutes. Maximal effort was established when respiratory exchange ratio (VCO2/VO2) reached or exceeded 1. The treadmill speed and slope at half maximal effort was used during the one-hour exercise bout which was initiated 40 minutes after the start of the meal.

Eligibility Criteria:
Inclusion Criteria:

* postmenopausal
* normal blood glucose
* no cholesterol medication
* age between 50 an 65 years
* overweight but not obese
* BMI between 25 and 30 kg/m2
* weight-stable during past 6 months
* exercise less than 20 minutes three times a week

Exclusion Criteria:

* metabolic disease other than hormonally-corrected hypothyroidism
* musculo-skeletal disability that would preclude exercise
* smoker
* do not meet inclusion criteria
Study of ProTmune for Allogeneic HCT in Adult Patients With Hematologic Malignancies

This study is a Phase 1, non-randomized, open-label/Phase 2 randomized, blinded study of ProTmune (ex vivo programmed mobilized peripheral blood cells) versus non-programmed mobilized peripheral blood cells for allogeneic hematopoietic cell transplantation (HCT) in adult subjects aged 18 years and older with hematologic malignancies. A total of 88 study subjects were treated in the trial at approximately 15 centers in the US.


Eligibility Criteria:
Key Inclusion Criteria:

1. Male and female patients aged 18 years and older, inclusive;
2. Patients must have a hematologic malignancy for which allogeneic hematopoietic peripheral blood cell transplantation is deemed clinically appropriate.

   Eligible diseases and stages include the following:
   1. Acute myeloid leukemia
   2. Acute lymphoblastic leukemia, including T lymphoblastic lymphoma with a history of marrow involvement
   3. Myelodysplastic Syndrome
   4. Chronic myelogenous leukemia
3. Availability of a suitable 8/8 HLA-A, -B, -C, and -DRB1-matched unrelated mPB donor;
4. mBP donor collection that meets protocol specifications;
5. Adequate performance status, defined as Karnofsky score greater than or equal to 70%;
6. For female patients of childbearing potential, all of the following criteria must be met:

   * They are not pregnant (i.e., female patients must have a negative serum pregnancy test at screening);
   * They are not breastfeeding;
   * They do not plan to become pregnant during the study; and
   * They are using an effective method of contraception from screening to the end of the study, unless their sexual partner is surgically sterile.
7. For male patients, agreement to use condoms with spermicide during sexual intercourse from screening to the end of study; and
8. Willingness and ability to sign an IRB/IEC-approved ICF before performance of any study-specific procedures or tests and to comply with protocol visits, and study procedures.

Key Exclusion Criteria:

1. Phase 1 only: Known bone marrow fibrosis; Phase 2 only: Bone marrow fibrosis grade 3 (severe) or greater;
2. Positive serology for human immunodeficiency virus (HIV) or human T-cell lymphotropic virus (HTLV) at any time prior to enrollment;
3. Currently uncontrolled bacterial, viral, or fungal infection (progression of clinical symptoms despite therapy);
4. Prior autologous or allogeneic HCT;
5. Active malignancy, other than the one for which the allogeneic mPB transplant is being performed, within 12 months of enrollment, excluding superficial basal cell and carcinoma in situ cervical cancer;
6. Pulmonary disease, renal dysfunction, hepatic disease, cardiac disease, neurologic disease;
7. Participation in another clinical trial involving an investigational product within 30 days prior to screening; or
8. Any condition or therapy, which, in the opinion of the Investigator, might pose a risk to the patient or make participation in the study not in the best interest of the patient.
Uterine Artery Pulsatility Index and Materno Fetal Outcomes

High Uterine artery index pulsatility (PI) is associated with small for gestationnal age but also with stillbirth and distress during labor.

measures of Uterine artery PI is made with transabdominal color flow during labor. The right and left uterine arteries are visualized at the crossover wth the external iliac arteries. PI is measured and the mean PI of the two vessels is calculated and expressed as multiple of the median (MoM).The outcomes stillbirth, distress and vaginal or cesarean delivery, apgar sore \<7 at 5 minutes, birth weight and maternal outcomes: preeclampsia, hemorrhage and other complications are noted.

Eligibility Criteria:
Inclusion Criteria:

* gestationnal age \>=34 weeks
* during labor

Exclusion Criteria:

* elective cesarean even if labor
* non elligible ultrasound criteria of good measurement of uterine artery PI