cyrilzakka/clinical-trials huggingface dataset:
Mediterranean Diet for Post-menopausal Women: Effects on Bone Turnover

The investigators propose a 24 week clinical research trial (12 week observational period followed by 12 week MedSD intervention) with feasibility of diet adoption and markers of bone turnover as the primary outcomes.

Postmenopausal women are at increased risk of osteoporosis and fracture. Components of a Mediterranean style diet (MedSD) are associated with reduced bone loss and fracture risk; however, the MedSD has not been tested in this population in the U.S. Therefore, fhe investigators propose a 24 week clinical research trial (12 week observational period followed by 12 week MedSD intervention) with feasibility of diet adoption and markers of bone turnover as the primary outcomes. The 12 week intervention will include provision of olive oil, walnuts and high n-3 polyunsaturated fatty acids (PUFA) fish to replace other fats and oils, processed snacks and red meat, respectively; accompanied with fruit, vegetable, whole grain and legumes intake recommendations. The investigators hypothesize the MedSD intervention will increase serum n-3 PUFA and decrease saturated fatty acids and n-6 PUFA and this will result in an improvement in bone turnover markers. The outcomes of the proposed intervention trial will promote further study of the benefits of a MedSD in the US. the investigators envision the research team to expand to other systems such as cardiovascular, metabolic, and inflammatory mechanisms in which less risk of disease is associated with a MedSD.

Eligibility Criteria:
Inclusion Criteria:

* postmenopausal women \> 65 years
* BMI\<30 kg/m2
* able to travel to clinical sites for follow-up visits
* willing to make no changes to habitual physical activity or calcium and vitamin D intake for the study duration

Exclusion Criteria:

* any disease that may affect bone metabolism, (i.e Paget's disease, primary hyperparathyroidism)
* cancers of any kind (except basal or squamous cell of skin) in past 5 years
* use of medication known to affect bone metabolism
* extreme dietary behaviors or supplementation in excess of DRI upper limits
* following a medically prescribed diet or dietary pattern similar to the MedSD
* history of chronic renal or liver disease
* history of hip fracture or known vertebral fracture within the past year
* persons with an allergy to fish or nuts.
Effects of Virtual Reality Glasses, Kaleidoscope and Distraction Cards on Pain and Anxiety During Blood Draw in Children

The study was designed as a randomized controlled experimental research with the purpose of determining the effect of distraction by using Virtual Reality Glasses, Kaleidoscope and Distraction Cards in reducing pain and anxiety during blood draw in children.

n the literature, it is stated that nurses should use pharmacological and non-pharmacological methods in pain and anxiety management in painful procedures. Evidence-based studies are needed to show the effectiveness of non-pharmacological methods in reducing pain during invasive procedures and to investigate the effects of easy-to-apply methods on pain. In light of this information, this study aimed to compare the effect of distraction by using Virtual Reality Glasses, Kaleidoscope and Distraction Cards in reducing pain and anxiety during blood draw in children.

This study is a prospective, randomized and controlled trial. Children aged 7 to 11 years who required blood draw were divided into three groups; Virtual Reality Glasses, Kaleidoscope, Distraction Cards and Control. Data were obtained through face-to-face interviews with the children, their parents, and the observer before and after the procedure. The children's pain levels were assessed and reported by the parents and observers and the children themselves who self-reported using Wong-Baker FACES. The children's anxiety levels were also assessed using the Children's Fear Scale.

The study population consisted of children aged 7 to 11 years who presented to the children's blood draw room of the hospital.

Sample of the study consisted of a total of 400 children who met the sample selection criteria and were selected via randomization method.

Children were randomized into three groups: Virtual Reality Glasses group (n= 100), Kaleidoscope group (n= 100), Distraction Cards group (n= 100) and Control group (n= 100).

Data were collected using the Interview and Observation Form, Wong-Baker FACES Pain Rating Scale, Children's Fear Scale.

Eligibility Criteria:
Inclusion Criteria:

* Children between the ages of 7-11,
* Volunteering of the child and parent to participate in the study,
* Blood draw for routine control purposes,
* Blood draw should be done by the same nurse,
* The needle on which blood draw will be performed must be of the same thickness.

Exclusion Criteria:

* The child has any acute or chronic disease,
* The child has a mental disability, vision, speech or communication problems,
* The parent has hearing, vision or verbal communication difficulties,
* The child used analgesics in the last 6 hours,
* Infection, disruption of skin integrity and rash in the area where the application will be made,
* Exclusion criteria were that the parent or child wanted to leave the study at any point.
Patient Monitoring in the Intensive Care Unit

a cross-sectional survey of nurses' perception of patient monitoring in the ICUs


Eligibility Criteria:
Inclusion Criteria:

* registered nurses in the ICUs

Exclusion Criteria:

-
dTDI During a SBT to Predict Extubation Failure in Preterm Infants

Weaning from mechanical ventilation is a critical issue and the diaphragmatic disfunction has been demonstrated to play an important role in extubation failure. the aim of present investigation is to evaluate diaphragmatic excursion velocity during in patients undergoing spontaneous breathing trial through tissue Doppler analysis in both inspiration and expiration.


Eligibility Criteria:
Inclusion Criteria:

* premature infants with gestational age \<32 weeks and supported by invasive mechanical ventilation ≥48 hours
* All the indications for extubation are met：cough or vomiting due to spontaneous breathing and sputum aspiration; ventilator parameters in recent 24 hours: MAP \< 8cmH2O, RR \< 30 times/min, FiO2 \< 30%; Arterial blood gas: pH \> 7.25, (PaCO2\< 60mmHg, BE \< 8mmol/L, oxygen saturation \> 90%
* a successful SBT
* parents or legal guardians sign informed consent to attend this study

Exclusion Criteria:

* accidental extubation
* chest CT or bronchoscopy during hospitalization indicated congenital airway dysplasia
* complex congenital heart disease
* congenital metabolic diseases, neuromuscular diseases
* severe brain injury
* surgical mechanical ventilation
* give up before extubation;
* pneumothorax or pleural effusion
* no consent is signed
Endorectal Three-dimensional Ultrasound in the Diagnosis of Cryptogenic Fistulas of the Rectum.

Prospective comparative parallel ultrasound diagnostic transrectal study in the diagnosis of cryptogenic fistulas of the rectum

It is planned to investigate 150 patients with cryptogenic fistulas. Patients will be divided into two groups: complete and incomplete internal fistulas of the rectum. Patients of the first group will undergo preoperative examination in the framework of transrectal ultrasound in B-mode, three-dimensional reconstruction of the image with a contrast of the fistula course with a solution of 1.5% hydrogen peroxide. Patients with incomplete internal fistulas of the rectum will also undergo transrectal ultrasound examination in B-mode and with three-dimensional image reconstruction. The results obtained in the two groups will be compared with the intraoperative revision.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with "fistula of the rectum"
* Patients diagnosed with cryptogenic fistulas
* Patients who have signed informed consent

Exclusion Criteria:

* Patients with perianal complications of Crohn's disease
* Рatients with post-traumatic fistulas
* Рatients with fistulas, drain pararectal cysts
* Рatients with anal fissures, complicated by rectal fistula
* Рatients who refused to participate in the study of their own free will
Stretching vs Foam-rolling

The study aims to compare the acute effects of the aplication of foam-rolling and stretching over the hamstrings flexibility.

The secondary objective is to determine which time can permit the obtention of better results.


Eligibility Criteria:
Exclusion Criteria:

* Pregnant women
* Musculoskeletal disorder in the last 3 months
* Surgical interventions in lower limbs in the last 6 months
* Psychological or nervous alterations
* Uncomprehension of the indications.
Prevention of Post-traumatic Stress Disorder by Telephone Based Cognitive Behavioral Therapy

This is a randomized controlled study comparing telephone-based cognitive behavioral therapy (CBT) for recent survivors of traumatic events with Acute Stress Disorder (ASD) or acute PTSD with a waitlist control group. Survivors with PTSD from both groups will receive face-to-face CBT one month from the traumatic event. The study's main hypothesis is that early telephone-based CBT will reduce the prevalence of PTSD three and eight months after the traumatic event.

Post-traumatic Stress Disorder (PTSD) is a prevalent and pervasive mental disorder. Studies have shown that there is a significant reluctance to use mental health services by trauma-exposed individuals at high risk for developing PTSD. Providing clinical services in combat or disaster zone might be difficult. Trauma-focused cognitive behavioral therapy (CBT) effectively reduces the prevalence of PTSD among recent survivors. Telephone based CBT was found to be effective in mood and anxiety disorders, but has not been tried in PTSD. Establishing the effectiveness of telephone based CBT has significant service delivery and public health implications. Preventing PTSD significantly reduces individuals' suffering and disability We will screen, by telephone, up to 1200 survivors of traumatic events, from a general hospital emergency department trauma registry list, randomize the first 240 with ASD or Acute PTSD to either early, telephone based cognitive behavioral therapy (ET_CBT) (n=120) or a no-treatment control condition (n=120). We will provide five sessions of ET-CBT to the former and compare the two groups three and eight months later.

Survivors from both groups who will continue to have PTSD at three months (after either treatment or waiting list), will receive 12 sessions of face-to-face, trauma focused CBT. A first phase of the study will consist of establishing the acceptance of ET-CBT and its main components (e.g., exposure to traumatic reminders) by survivors, and optimizing the protocol. It will involve 20 survivors and no randomization. Subsequent to that phase we will start recruiting for the main study. The study's main hypothesis is that early CBT will reduce the prevalence of PTSD three and eight months after the traumatic event.

Eligibility Criteria:
Inclusion Criteria:

* Adults
* Exposure to psychologically traumatic events
* Diagnosis of Acute Stress Disorder or Post-traumatic Stress Disorder
* Up to four weeks after trauma exposure

Exclusion Criteria:

* Chronic PTSD
* Past and present psychosis, bipolar disorder, opiate or stimulants use
* Medical or surgical condition that interfere with subjects ability to participate in the study or sign an informed consent
* Lack of fluency in the study's main language (Hebrew)
Early Placental Insufficiency Screening

To assess the role of uterine artery and maternal serum PlGf and sflt-1 and their combination in screening for pre-eclampsia and small -for-gestational age (SGA) fetuses at 12-14 weeks of gestation

Pre-eclampsia (PE) and intrauterine growth restriction (IUGR) are known as major factors in perinatal morbidity and mortality. Routine antenatal care is focused on the detection of women at increased risk to apply this population a program of careful monitoring and appropriate intervention.

Uterine artery Doppler during anomaly scan at 12 to 14 weeks in selected women at increased risk, has proved to be accurate to detect those who will develop PE or IUGR during the second half of pregnancy.

A variety of angiogenic proteins have been studied as potential markers for pre-eclampsia. Among these protein Plgf and sflt-1 have respectively demonstrated higher and lower levels in pregnant women who will subsequently develop pre-eclampsia.

Our study is aimed to evaluate the performance of serum Plgf and sflt-1 measurement in association with uterine artery Doppler as a screening for placental insufficiency.

Eligibility Criteria:
Inclusion Criteria:

* Chronic hypertension under medication
* Insulin or not insulin dependant preexisting diabetes
* Previous history of pre-eclampsia
* Previous history of unexplained stillbirth
* Previous history of placental abruption
* Previous history of SGA (\< 10th centile)
* History of pre-eclampsia or chronic hypertension before 45 years in the mother or a sister
* History of vascular pathology before 50 years in the father
* Obesity (BMI\>26)
* Nulliparous after 38 years
* Assisted conception with donor
* Primipaternity after 38 years old or before 20 years old

Exclusion Criteria:

* Multiple pregnancy
* Pregnancy requiring termination
* Unability to understand the study
* Thrombophilia
* treatment with heparin
A Study Of PF-04447943 Compared To Placebo In Subjects With Mild To Moderate Alzheimer's Disease

The purpose of this study is to evaluate the effects of PF-04447943 compared to placebo on cognitive, behavioral and overall symptoms of Alzheimer's disease; evaluate the safety and tolerability of PF-0444793 compared to placebo; and determine the levels of PF-04447943 in the plasma over the course of the study.


Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate Alzheimer's disease (MMSE 14-26)
* Good general health (such controlled conditions as Type 2 diabetes and hypertension allowed)

Exclusion Criteria:

* Use of acetylcholinesterase inhibitors (donepezil, rivastigmine, or galantamine) or memantine within 12 weeks of the start of the study
* Significant cardiovascular disease in the past 6 months
* Illness other than Alzheimer's disease that could contribute to cognitive impairment
* History of stroke or seizure disorder
Evaluation of the Efficacy of the Becoming Parents Program

The primary aim of this study is to test the effectiveness of the Becoming Parents Program--a couple focused educational program for couples having a first child--on individual and couple well being and the parent-infant relationship over the first three years of parenthood.

Other aims of this study are to evaluate the cost of implementing the Becoming Parents Program; to describe changes in individual and couple well-being over time, viewing the transition to parenthood from a developmental perspective using data from the control group; examine the various variables in the study over time from pregnancy through three years post-birth.

The transition to parenthood is extremely difficult for both mothers and fathers, yet education and support during this major life transition emphasize getting through labor and birth, rather than preparing couples for the many changes accompanying parenthood. The classes of the Becoming Parents Program provide information and skills for taking care of the couple relationship, taking care of self, interacting with the baby, and the many ways becoming parents changes peoples' lives.

The purpose of this study is to evaluate the effects of the Becoming Parents Program classes on individual well being (measured by symptoms of depression and stress, perceived health, risk behaviors, health practices, health resource utilization), couple well-being (measured by marital satisfaction and stability), and the parent-infant relationship (measured by observation of the mother feeding the baby and the father teaching the baby) over the first three years of parenthood. Information is gathered by paper-and-pencil questionnaires during pregnancy, and at six months, one year, two years, and three years post-birth and by observation of parent-infant interaction at three months post-birth and videotaping and coding of couple interaction at six months post-birth.

Hypotheses are that couples who receive the Becoming Parents Program classes as compared to the couples who do not will:

1. have higher levels of marital satisfaction
2. have lower levels of depression
3. have less symptoms of stress
4. have higher levels of marital stability
5. communicate more effectively about a problem issue
6. have higher levels of health and well-being
7. score higher on observational evaluations of parent-infant interaction
8. report they are more satisfied with parenting, their partner's involvement in parenting their child, and with who does what in their family

Eligibility Criteria:
Inclusion Criteria:

* married couples
* expecting the birth of a first child
* not more than 30 weeks pregnant

Exclusion Criteria:

* consider their couple relationship in immediate danger or breaking up
EW and Self-Guided PST in Cancer Survivors and Caregivers

To assess the feasibility and acceptability of expressive writing + problem solving therapy (EW+PST) among cancer survivors and informal caregivers

This is a single-arm proof-of-concept behavioral clinical trial of a self-guided expressive writing and problem-solving therapy intervention for adult cancer survivors and adult informal caregivers thereof

Eligibility Criteria:
Inclusion Criteria:

* Cancer diagnosis of any type OR informal caregiver (family member, friend, and/or spouse who provides the majority of caregiving) of someone with cancer
* Patient of Virginia Commonwealth University (VCU) Massey Cancer Center OR informal caregiver (family member, friend, and/or spouse) of a VCU Massey Cancer Center patient

Exclusion Criteria:

* Physical inability to write
* Non-English speaker/writer
* Inability to consent to study participation
Interferon Gamma Induced Protein 10 (IP-10) in a Clinical Decision Support Protocol in COVID-19 Patients

The proposed project will pilot incorporation of rapid serial measurements of IP-10 into a CDS tool for moderate and severe COVID-19 patients.

The tool was applied to all comers with confirmed COVID-19 diagnosis at a secondary medical center in Israel.


Eligibility Criteria:
Inclusion Criteria:

* PCR- positive for COVID-19

Exclusion Criteria:

* \<18 years of age
Evaluation of Mucoadhesive Tacrolimus Patch on Caspase-3 Inducing Apoptosis in Oral Lichen Planus

tacrolimus has been widely used as an immunosuppressant. the objective of this study was to evaluate the clinical efficacy of tacrolimus 0.1 % in muco adhesive patch compared to tacrolimus or corticosteroids in paste forms for symptomatic oral lichen planus, and to investigate the effect of topical tacrolimus or corticosteroids on the expression of caspase-3 in oral lichen planus as an early marker of apoptosis using immunohistochemically analysis

thirty patients with erosive or atrophic OLP were randomly assigned into three equal groups to receive topical steroid ( triamcinolone acetonide 0.1%), four times per day ( Group 1), tacrolimus paste 0.1% four times per day ( Group 2) , and tacrolimus patch 2 times per day ( Group 3). all groups are given treatment for 8 weeks and 4 weeks follow up period without treatment. Photographs of the most severe lesion were taken ( marker lesion ) in each patient and analyzed for total ulcerative area (TUA), total atrophic area (TAA). patients were also assessed using clinical scores (CS) and visual analogue scale (VAS). pre treatment and post treatment specimens were immunohistochemically stained to detect expression of caspase-3.

Eligibility Criteria:
Inclusion Criteria:

* clinically and histologically proven painful bullous/erosive or atrophic forms of OLP

Exclusion Criteria:

* lichenoid lesions smoking systemic conditions pregnancy or breast feeding known hypersnstivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation
A Registered Cohort Study on Brain Calcification

Brain calcification is a common neuroimaging feature in patients with metabolic, neurological, or developmental disorders, infectious diseases, traumatic or toxic history, as well as in otherwise normal older people. To understand the clinical and genetic characteristics of brain calcification, we establish a cohort of brain calcification to follow up patients with brain calcification.


Eligibility Criteria:
Inclusion Criteria:

* Patients with brain calcium deposit(s) based on examinations of CT scans
* Patients with total calcification score(TCS) greater than the physiological threshold
* Relatives of brain calcification patients.
* Unrelated healthy controls
* Participants or Parent(s)/legal guardian(s) willing and able to complete the informed consent process

Exclusion Criteria:

* Brain calcification caused by specific secondary factors such as infection, poisoning, and trauma
* Participants declining or unable to comply with trial procedures and visit schedule
Subconjunctival Bevacizumab and Recurrent Pterygium

A study to research whether subconjunctival bevacizumab injection may potentially suppress neovascularization in pterygium, retarding and decreasing the size of recurrent pterygium.

1. Pacients with recurrent pterygium
2. Anti-VEGF therapy -Bevacizumab

Eligibility Criteria:
Inclusion Criteria:

* Recurrent pterygium

Exclusion Criteria:

* Pregnant or lactating women
* History of myocardial infarction
* History of stroke