cyrilzakka/clinical-trials huggingface dataset:
Examining The Effect of Chronotype Differences on Sleep Quality and Pregnancy Symptoms in Pregnant Women

Purpose: The aim of this study was to examine the effect of chronotype differences on sleep quality and pregnancy symptoms in pregnant women.

Methods: Eighty-five pregnant women in the second trimester were included in the study. The chronotypes of pregnant women were determined using the Morningness-Eveningness Questionnaire (MEQ). Then, Oral Glucose Tolerance tests were performed on the participants between 24-28 weeks. Also, pregnant women's nausea and vomiting conditions with the Pregnancy-Unique Quantification of Emesis and Nausea (PUQE) and sleep quality with Pittsburgh Sleep Quality Index (PSQI) were evaluated.

Purpose: The aim of this study was to examine the effect of chronotype differences on sleep quality and pregnancy symptoms in pregnant women.

Methods: This study is a single-blind (participants), parallel trial. It was performed in line with the principles of the Declaration of Helsinki. The followings were the study's inclusion requirements: being between the ages of 18-40, having a singleton pregnancy, being in the second trimester, and not having any known chronic disease. Exclusion criteria are working night shifts, having a high-risk pregnancy, and having a neurological or orthopedic disease. Eighty-five pregnant women in the second trimester were included in the study. The chronotypes of pregnant women were determined using the Morningness-Eveningness Questionnaire (MEQ). Then, Oral Glucose Tolerance tests were performed on the participants between 24-28 weeks. Also, pregnant women's nausea and vomiting conditions with the Pregnancy-Unique Quantification of Emesis and Nausea (PUQE) and sleep quality with Pittsburgh Sleep Quality Index (PSQI) were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* being between the ages of 18-40,
* having a singleton pregnancy, being in the second trimester,
* not having any known chronic disease.

Exclusion Criteria:

* working night shifts,
* having a high-risk pregnancy,
* having a neurological or orthopedic disease.
The Sweet Dreams Study - Accuracy of Sleep Trackers in Children

The study aims to evaluate the accuracy of sleep trackers in children aged 2 to less than 18 years. Children undergoing polysomnography, the gold standard for assessing sleep quality and duration, at Arkansas Children's Hospital may be eligible to participate. Participants will be asked to wear sleep trackers on the day of their sleep test. The data collected from the sleep trackers will be compared with the polysomnography results to determine the devices' accuracy.

Participants will meet the research team at Arkansas Children's Hospital (ACH) two to three hours before their scheduled sleep test and are required to bring a stool sample from the child to the visit.

During the visit, the research team will gather information about the child's home environment and medical history, including parent marital status, parental education level, household income, and other factors. Questionnaires will also cover topics such as the child's growth and development, diet, physical activity, use of substances like tobacco and alcohol, and mood. Any questions that cause discomfort may be skipped by the child or their parent.

A brief physical exam will be conducted to measure the child's weight, height, blood pressure, and heart rate. Sleep trackers will then be programmed and placed, with two worn on the wrist and two around the waist. Instructions on how to remove and reattach the trackers will be provided to ensure proper use.

After completing the sleep test at ACH, the sleep trackers must be left in the sleep clinic. All four trackers must be returned, and parents will be asked to report if the trackers were removed at any point during the study.

Eligibility Criteria:
Inclusion Criteria:

* Age 2 to \<18 years
* All BMIs
* Scheduled at PSDC for evaluation of obstructive sleep apnea, snoring, or noisy breathing during sleep.

Exclusion Criteria:

* Known diagnosis of sleep disorder
* Neurological disorders (e.g., epilepsy, cerebral palsy, etc.)
* Autism spectrum disorder
* Attention deficit hyperactivity disorder
* Oppositional defiant disorder
* Chronic kidney disease
* Hormonal disease
* Autoimmune diseases
* Bleeding disorders
* Chronic infections (e.g., HIV, hepatitis B)
* Mental health disorders (e.g., depression, anxiety)
* Liver disease (e.g. hepatitis)
* Referral for evaluation of disorders other than obstructive sleep apnea, snoring, or noisy breathing during sleep.
* Pre-existing medical conditions or medications as determined by the investigators to affect the outcomes of interest.
* Refusal to authorize study investigators to access data from the polysomnography test conducted at the Arkansas Children's Hospital PSDC.
Galantamine in the Treatment of Post-Traumatic Headache

Most patients with CPTH present with additional major cognitive, behavioral and somatic problems. Most drugs used currently have a negative influence on cognition. Therefore, treatment strategies addressing both the headache and cognitive disturbances in patients with CPTH are necessary. (CPTH; Chronic Post Traumatic Headache).

Headache is the most common symptom after a closed head injury, persisting for more then 2 months in 60% of the patients. CPTH is an important cause of consultations in neurology offices and headache clinics, posing a severe burden and affecting the quality of life of sufferers.

Eligibility Criteria:
Inclusion Criteria:

Age range 18-75 CPTH according to ICHD-2 Fertile woman using adequate birth control Willing and able to give informed consent Willing and able to complete the entire course of the study to comply with study instructions Stable does of preventive medication

-

Exclusion Criteria:

Subject is pregnant or lactating Significant medical or psychiatric disease Previous failure to 4 or more adequate trials of preventive medication Patient on non-stable dose of medication used to prevent CPTH

-
Prediction Using Connected Technologies for Diabetes

In this study, adults with pre-diabetes will be prospectively enrolled for data collection to design prediction models that integrate electronic health record data and patient-generated activity data. Patients will be randomized to receive either a waist-worn or wrist-worn wearable device for 6 months to capture patient-generated activity data.

Patients with suboptimal glycemic control could be better managed if these higher risk patients could be identified and effective interventions were then targeted towards them. However, most practice settings perform infrequent laboratory testing every 3 to 6 months, if not at longer intervals. Current models to predict change in glycemic control perform poorly and do not take into account the behaviors that occur between these intervals. In this study, we will compare different methods to use data on daily health behaviors collected by wearable devices to enhance risk prediction models. Adults with pre-diabetes will complete a series of surveys and baseline assessments and then will be randomly assigned to use a waist-worn or wrist-worn wearable device for 6 months. Measures of HbA1c and LDL will be obtained at baseline and at 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. Be 18 years or older
2. Be able to provide informed consent
3. Have a smartphone or tablet compatible with the wearable device smartphone application and be willing to use the wearable device for 6 months
4. Baseline hemoglobin A1c of 5.7 to 6.4

Exclusion Criteria:

Participants will no be eligible if they have any medical condition or other reason that will likely prohibit them from completing the 6-month study
Oxymorphone Extended Release (ER) in Opioid-Naive Patients With Chronic Pain

The purpose of this study is to determine if oxymorphone ER is effective and safe in treating chronic pain in opioid-naive patients.

The purpose of this study is to assess the effectiveness and tolerability of oxymorphone ER for the treatment of moderate to severe chronic pain in opioid-naive patients. Patients are gradually titrated from a 5mg dose of oxymorphone ER (taken every 12 hours) until stabilized dose is achieved. The study design is an open-label, nonrandomized 6-month study with a titration/stabilization period of ≤ 1 month followed by a 5-month maintenance period.

Eligibility Criteria:
Inclusion Criteria:

* Currently receive a stable non-opioid analgesic regimen
* Have an initial pain intensity score of greater than or equal to 40 mm on a 100-mm Visual Analogue Scale (VAS) and a categorical pain rating of moderate or severe on a categorical scale of none, mild, moderate, or severe
* If female, must be practicing abstinence or using a medically acceptable form of contraception
* Understand written and spoken English
* Have been informed of the nature of the study and provided written informed consent.

Exclusion Criteria:

* Positive pregnancy test (females only)
* History of or active asthma or emphysema
* Clinically significant hepatic impairment
* Received any of the following medications within 48 hours prior to dosing:

  * Dextromethorphan-containing medications (over-the-counter \[OTC\] cough and cold preparations, such as Vicks Formula 44)
  * St. John's Wort \>1000 mg/day
* Received monoamine oxidase inhibitor (MAOI) drugs within 2 weeks prior to dosing
* Are not stabilized on the following medications for at least 4 weeks prior to dosing:

  * Tricyclic antidepressant drugs
  * Serotonin reuptake inhibitors
  * Amphetamines used for attention-deficit/hyperactivity disorder (ADHD)
* History of alcohol or substance abuse within the last 3 years
* History of opioid abuse within 6 months prior to study entry
* Have a known oxymorphone sensitivity or allergy
* Have scheduled an elective surgery or procedure during the study that would not permit continuation of study medication, and/ or require another analgesic not currently taken by the patient
* Have received an investigational drug or product or participated in an investigational drug study within a period of 30 days prior to receiving study medication
* Have a known allergy or significant reaction to opioids
* Have been a participant in a previous oxymorphone clinical trial
* Have a history of seizure (Patients with a history of juvenile febrile seizures may be included if there has been no seizure history within the past 10 years).
The Comparison of Effect of Four Different Treatment Protocols on IVF Outcomes in Poor Responders Undergoing in Vitro Fertilization.

The comparison of effect of four different treatment protocols: Antagonist/letrozole protocol, microdose flare-up protocol, Antagonist/clomiphene protocol, Antagonist on IVF outcomes in poor responders undergoing in vitro fertilization; a prospective randomized-controlled study.


Eligibility Criteria:
Inclusion Criteria:

Criteria for definition of poor responders included at least one of the following

1. Anti müllerian hormone \<1.1 ng/ml and/or a previous poor ovarian response (≤3 oocytes with a conventional stimulation protocol).
2. Primary infertile patients
3. BMI≤30 kg/m2 were included this study.

Exclusion Criteria:

-
Efficacy of Whole-body Vibration on Balance Control, Postural Stability and Mobility After Thermal Burn Injuries.

This study will be conducted to investigate the effect of whole-body vibration device on Balance control, postural Stability and mobility after thermal burn injuries.

40 patients with deep second-degree burn involving the lower limbs and trunk (TBSA: 35-40%), will be randomly assigned either into the experimental group, received whole body vibration (WBV) plus the routine physical therapy program or the control group, received the same routine physical therapy program. All treatment interventions will be applied at a frequency of three sessions per week for 8 weeks. Anteroposterior stability (APS), Medial lateral stability (MLS), Time up and go test (TUG) test, and Berg balance scale will be the outcome measures of the study.

Eligibility Criteria:
Inclusion Criteria:

* Age ranged between 20 and 45 years,
* Deep 2nd degree of thermal burn of lower limb and trunk with (35-40%) surface area of burn as measured by "rule of nine" method, with complete wound healing or after 6 weeks from the injury.
* Body mass index of between 17 and 35, with no history of neurological disorders or injuries to the lower extremities.

Exclusion Criteria:

* Patients with open burn wound,
* Patients diagnosed with acute rheumatoid arthritis,
* Joint replacement within the past year,
* History of traumatic spine within the past six months,
* Prosthesis,
* Recent fracture or bone disease.
Evaluation of the Zynex Blood Volume Monitor in Healthy Adult Patients During a Blood Draw

Non-invasive monitoring to measure changes in blood volume.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Between 18-35 years of age
* Weight between 130-200 pounds

Exclusion Criteria:

* Known cardiac disease
* Recent caffeine intake
* Tobacco use in the (4) hours prior to screening
* Infection
* Pregnancy
* Hemoglobin \<13.5 g/dl
Stop Ovarian Cancer Young; Effect of the Opportunistic Salpingectomy on Age of Menopause

The aim of this study is to evaluate the long-term safety of on the onset of menopause.

The aim of this study is to evaluate the long-term safety of on the onset of menopause. To investigate the effect of Opportunistic Salpingectomy on the age of menopause, we will compare age of menopause in women who underwent sterilization through opportunistic salpingectomy with a control group consisting of women who underwent sterilization by tubal ligation or who had no sterilization.

Eligibility Criteria:
Inclusion Criteria:

Intervention group

* Undergoing an Opportunistic Salpingectomy as sterilization method
* Premenopausal status at enrolment
* Age between 30 and 45 years
* Will have residual ovarian tissue after surgery
* Able to understand the written or spoken Dutch language
* Gives consent for participating in surveys

Control group

* Premenopausal status at enrolment
* Either sterilization by tubal ligation or no sterilization at all
* Age between 35 and 45 years
* Able to understand the written or spoken Dutch language
* Gives consent for participating in surveys

Exclusion Criteria:

* Postmenopausal status at enrolment
* Under the age of 35 or above 45
* Previous salpingectomy of oophorectomy
* Previous hysterectomy
* Women with abnormal karyotype (such as Turner Syndrome and Fragile X syndrome)
* Underwent chemotherapy or radiation
* Unable to understand the written or spoken Dutch language
Short and Long-Term Effects of Prebiotic, Probiotic and Synbiotic on Appetite and Dietary Intake

Prebiotics and probiotics are thought to play a role in appetite control and body weight regulation; but little is known about this topic. This study was planned to examine the effects of inulin and Lactobacillus casei 431 on short and long term fasting, satiety, dietary intake, and serum hunger and satiety hormone levels. The study consisted of 2 phases. In the first phase, a double-blind, randomized, crossover study design was used, and it was performed with 16 healthy male participants aged 19-30 years. In this phase, the prebiotic (200mL milk+16g inulin), probiotic (200mL milk + Lactobacillus casei 431 \[\>106 cfu/mL\]+16g maltodextrin), synbiotic (200mL milk+16g inulin + Lactobacillus casei 431 \[\>106 cfu/mL\]) and control (200mL milk+16g maltodextrin) test drinks were consumed with a standard breakfast on four separate test days by one week intervals, and their effects on dietary intake, hunger, satiety and appetite were assessed. The second phase was performed with 21 healthy male participants aged 19-30 years, using a placebo-controlled double-blind, randomized study design. Participants consumed the control (200mL milk+16g maltodextrin) or synbiotic (200mL milk+16g inulin+ Lactobacillus casei \[\>106 cfu/mL\]) test drinks for 21 days with their habitual diet. At the beginning and end of the intervention, blood samples were collected at 0., 30., 60. and 120. minutes following the test day protocol to analyse serum glucose, insulin, ghrelin, obestatin and PYY (peptide tyrosine tyrosine) levels. In addition, dietary intake, hunger, satiety and appetite of participants were compared.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male
* 19-30 years old
* Body mass index (BMI) of 18.5-29.9 kg/m2

Exclusion Criteria:

* Being female
* Being younger than 19 years old or older than 30 years old
* Having a BMI that is lower than 18.5 kg/m2 or higher than 29.9 kg/m2
* Smoking
* Having any metabolic disease
* Losing or gaining weight in the past 3 months
* Following a special diet
* Using any medicine which could affect the outcome of the study
* Having food intolerance and allergies
* Taking regular probiotic or prebiotic foods or supplements
* Not consuming breakfast or lunch regularly
* Being a professional athlete
* Having unhealthy eating attitude that assessed using three factor eating questionnaire (having cognitive restraint score \>13, uncontrolled eating score \>18, and emotional eating \> 6)
* Having depression that was assessed using Beck's Depression Inventory (having a score \>9)
Cooking and Nutrition Education for Health Among Adults With Diabetes

This study is a multi-dimensional therapeutic lifestyle program that offers cooking and nutrition education as well as email-based health coaching to diabetic patients in an underserved Cleveland community. This is an innovative project as it is one of the first focused efforts within this community to improve diabetes control and prevent diabetes progression through cooking and nutrition as well as to systematically measure both clinical and behavioral outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Current State of Ohio Medicaid recipient
* Current diagnosis of diabetes, as reported in the electronic medical record
* Completed at least one diabetes education visit at STJHC
* Have daily access to a functional kitchen in home

Exclusion Criteria:

* Pregnancy or lactation or plans to be pregnant or lactate during study
* Current alcoholism or abuse of recreational drugs
* Self-reported or history of HIV or hepatitis or active tuberculosis
* Travel plans that do not permit full participation especially during the first 8 study visits
* Recent unexplained weight loss (10 pounds or more in past 3 months)
* Any diagnosis that would interfere with or prevent a change in diet
The Female Health Dietary Intervention Study

This study has two phases:

1. In phase 1 of the study (8 weeks),the effect of two different low calorie diets on manifestations of PCOS, including risk factors for the metabolic syndrome and cardiovascular risk profile will be compared.
2. In phase 2 the long term effect (next 44 weeks) on sustained weight-loss and the above mentioned parameters will be compared and evaluated.

Weight loss is an important and effective treatment of morbidly obese women with PCOS. Effective weight reduction will improve manifestations of PCOS and risk factors for developing type 2 diabetes and coronary heart diseases. We compare the effect of two isocaloric low calorie diets (LCD), - one powder-based shake-diet and a fiber rich diet on the above mentioned parameters. In addition we want to compare the weight-maintenance effect the next 44 weeks of two different follow-up programs: A usual care- and a lifestyle-program.

Eligibility Criteria:
Inclusion Criteria:

* Woman (European Caucasian)
* PCOS
* BMI = or \> 35

Exclusion Criteria:

* Cushing syndrome
* Adrenal hyperplasia
* Androgen-producing tumors
* Anovulation caused by hyperprolactinemia
* Pregnancy, breast feeding
* Use of oral contraceptives/hormone treatment/insulin-sensitizing agents
Efficacy of Azithromycin in MSAF Cases to Improve Maternal and Neonatal Outcomes

Meconium stained amniotic fluid increases the risk of maternal complications (e.g., dystocia, operative delivery, and postpartum endometritis) and neonatal complications (e.g., sepsis, admission to the neonatal intensive care unit \[NICU\], and meconium aspiration syndrome). The goal of the study is to compare between Azithromycin vs Placebo in cases of meconium stained amniotic fluid during the first stage of labor in multigravida women and their effect on maternal and neonatal outcomes.

Meconium stained amniotic fluid, a troublesome situation both for obstetrician and pediatrician, it is associated with high rates of caesarean section, perinatal morbidity and mortality. The rate of meconium-stained amniotic fluid varies from 12 to 20%.It is higher in underdeveloped countries.Our study design would be a prospective randomized trial. Consented, eligible pregnant women presenting during the first stage of labor at or more than 37 weeks of gestation with meconium stained amniotic fluid will be randomized to receive Azithromycin capsule (Zithromax, Pfizer) (250 mg / 12hrs on empty stomach for 3 days)(Group 1).Group 2 will be offered placebo capsules (manufactured in pharmacy department with the same shape, color and consistency as Azithromycin capsule for 3 days).

Eligibility Criteria:
Inclusion Criteria:

1. Multigravida pregnant women with meconium stained amniotic fluid encountered either by spontaneous/artificial amniotomy during the first stage of labor in the ward provided that the gestational age at delivery is 37 weeks of gestation or more.
2. Singleton living gestation
3. Cephalic presentation
4. Adequate pelvis
5. An informed written consent for the proposed study.

Exclusion Criteria:

1. Primigravids
2. Women with previous cesarean section
3. Multifetal gestation
4. Intrauterine fetal death
5. Malpresentations
6. Prematurity (\<37 weeks )
7. Abnormally invasive placenta during the current pregnancy
8. Medical disorders with pregnancy
9. Contracted pelvis
10. Evidence of maternal infection
11. Allergy to azithromycin or other macrolides that is self-reported or documented in the medical record.
Illness Expectations in Pulmonary Fibrosis

This study aims to delve into the constructs of illness beliefs and expectations among patients with Pulmonary Fibrosis, exploring how these beliefs and expectations may influence the treatment journey, including oxygen therapy, non-invasive ventilation therapy, and pharmacological treatments.


Eligibility Criteria:
Inclusion Criteria:

* Patients with pulmonary fibrosis
* Patients using oxygen therapy
* Patients using non-invasive ventilation
* Patients undergoing pharmacological treatment
* Patients who speak and understand the Italian language

Exclusion Criteria:

* Patients who do not provide their consent
* Patients without pulmonary fibrosis
* Patients with psychiatric disorders or cognitive impaiment
* Patients who don't speak or understand Italian language