cyrilzakka/clinical-trials huggingface dataset:
Effects of Sleep Quality on Melatonin Levels and Inflammatory Response After Major Abdominal Surgery

Endogenous melatonin is produced by the pineal gland at night under normal conditions and regulates the sleep-wake cycle. Artificial light administered at night suppresses melatonin production and sleep disturbances are accompanied by abnormal melatonin secretion such as phase delay. Therefore, dramatic disturbances of endogenous rhythms in intensive care unit patients have remarkable effects on melatonin production. In addition to its physiological roles in regulating sleep patterns, melatonin has been demonstrated to provide antiinflammatory effects in experimental models. Although some previous studies have investigated the circadian pattern of melatonin in intensive care unit patients, the investigators think that the present study is the first one that will assess the effects of controlling noise and light on melatonin and inflammatory response after major abdominal surgery.

This study is going to be conducted in accordance with the Helsinki Declaration and has been approved by Eskisehir Osmangazi University Ethics Committee. Forty consecutive patients, aged 18-65, who will undergo elective major abdominal operations will be enrolled in the study after obtaining informed consent. All patients will receive adequate postoperative pain management with the Pain Buster ® system and patient-controlled intravenous analgesia (PCA). The patients will be randomly assigned to either the experimental group or the control group. The control group will receive the usual care. The patients in the experimental group will be screened in the side-rooms where normally the patients who either have infections or are at risk of infection, are nursed. The study intervention will include dimming the lights to 40 lux and closing the doors of the side-room to decrease the noise level below 40 decibels (dB) between 11:00 p.m.-5:00 a.m.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective major abdominal surgery

Exclusion Criteria:

* Any evidence of inflammatory diseases during the postoperative care (e.g. anastomotic leakage)
The Effects of Therapeutic Exercises on Kinesiophobia in Haemophilic Patients.

this study evaluates the effects of therapeutic exercises on kinesiophobia and health-related quality of life in adult haemophilia patients. half of participants will receive therapeutic exercises and verbal information about the positive effects of therapeutic exercises on physical pathologies due to hemophilic arthropathy while the other half will receive only verbal information.

in haemophilia patients recurrent musculoskeletal hemorrhage cause to arthropathy characterized by severe degeneration of joint cartilage and bones. arthropathy leads to decrease in the patient's health related quality of life. furthermore pain, risk of injury and lack of motivation lead to decreased physical activity and development of kinesiophobia.

Eligibility Criteria:
Inclusion Criteria:

* Individuals older than 18 years
* diagnosed with hemophilia A or B
* having at least one joint with hemophilic arthropathy
* without cognitive problems
* speaking turkish

Exclusion Criteria:

* Individuals with another congenital coagulopathy such as Von Willebrand Syndrome,
* unable to walk due to hemophilic arthropathy
* developing inhibition against factor VIII-IX
Personal Responsibility Education Program Innovative Strategies: Digital Initiative for Youth

This randomized control trial (RCT) will assess an innovative demonstration project to improve adolescent sexual and reproductive health among highly mobile and marginalized youth in Fresno County, California. The Digital Initiative for Youth intervention combines existing, in-person, group-based, comprehensive sexual health education with wraparound digital technologies. The technological component was designed by Youth+Tech+Health using a "youth-centered" design approach and the intervention is implemented by Fresno Economic Opportunities Commission (Fresno EOC). The University of California, San Francisco is the external evaluator. The RCT will assess health and behavioral outcomes at three time points (baseline, 4 months, 10 months).

The Digital Initiative for Youth (DIY) is an innovative, youth-centered, digital intervention that aims to improve the health and well-being of adolescents ages 13-19 in Fresno County, California. In particular, it will address the needs of homeless and unstably housed youth, youth of color, sexual minority youth, and Native American youth using a trauma-informed approach and positive youth development framework.

DIY combines existing, in-person, group-based, comprehensive sexual health education with an app designed in consultation with youth. DIY is built on three strategies: positive youth development, youth-centered design, and wraparound technologies. It will focus on four main areas: sexual health and contraceptive use, healthy relationships, educational and career development, and life skills. The intervention includes six hours of in-person education and an app that includes a resource locator, goal setting, text message reminders, and additional information and referrals.

This study is funded through the Personal Responsibility Education Program Innovative Strategies (PREIS), which is administered by the Family and Youth Services Bureau, part of Health and Human Services,

Fresno EOC is responsible for site and participant recruitment as well as the implementation of the intervention. Participants are randomized at the cohort (group) level. All control group participants will be invited to participate after completion of the long-term follow up period.

Eligibility Criteria:
Inclusion Criteria:

* Speak/understand Spanish or English
* Live within Fresno County, California at baseline (may move out afterward)
* Age between 13-19
* Have access to a smart phone or internet (does not need to own)

Exclusion Criteria:

* Do not live in Fresno County, California at baseline
* Do not speak or understand Spanish or English
* Severe mental health issues that prevent them from participating
Stevia Rebaudiana Bertoni on Levels of GCF Glucose and Bio-markers in Diabetics.

With the increase in the incidence of diabetes and obesity, among other artificial sweeteners the need of natural non-caloric sweetener with acceptable taste and without any adverse effects is demanding.So,the use of stevia presents beneficial effects to general and oral health and its properties could result potentially effective in the treatment of periodontal diseases.

Stevia is considered as a novel molecule, because it is 100% natural and non caloric sweetener, with more sweetness than sucrose, without any adverse effects. It also demonstrates multiple benefits like anti-plaque effect, anti-diabetic effect, anti-periodontophatics properties, anti-hypertensive properties, anti-cariogenic properties etc. There are many studies conducted on stevia in humans, which justifies my study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects that will be included in the study are in the age group ranging from 20-70 years -with established diabetes and under medication to maintain normal glycemic state i.e;Hb1Ac \< 7％.
* Oral findings including the presence of minimum of 16 natural teeth with minimum of 4 nonadjacent sites showing pocket depths≥ 5 mm.

Exclusion Criteria:

Subjects will be excluded from the study if they are using

* any type of mouth-rinses or if they had underwent any periodontal therapy within the 3-months of the study or
* if they were under antibiotics within the 3-months of the study.
Evaluation of Oral Morphine Gel in Oral Mucositis Induced by Chemotherapy in Children and Young Adults

Chemotherapy kills tumor cells but can also damage healthy cells and cause significant digestive disorders such as ulcers of the mouth, called mucositis. Mucositis are transient but their intensity may require special measures. Mucositis are painful and morphine gel or intravenous morphine is used to relieve pain.

However, the pain of oral mucositis induced by chemotherapy is not completely relieved by morphine administered intravenously.

As part of the study, the investigators want to evaluate an oral gel containing a small amount of morphine so that it acts directly on the mucositis. The investigators believe that the direct action of morphine on mucositis may be more effective on pain.

The objective of the study is to compare the analgesic efficacy of topical morphine gel versus placebo gel in the pediatric oncohaematology oral mucositis induced by chemotherapy in children treated with systemic opioids.

To confirm these results, we propose to conduct a randomized double-blinded study designed to compare the analgesic efficacy of morphine oral topical gel versus placebo gel in children over 5 years with mucositis induced by chemotherapy and treated with systemic opioids. This analgesic effect should reduce persistent pain to maintain oral feeding and thus delay the implementation of parenteral nutrition, and hence reduce the dose of systemic morphine and also reduce the adverse effects of opioids

Eligibility Criteria:
Inclusion Criteria:

* Children older than 5 years or adults over 18 and up to 25 years with a chemotherapy
* greater than or equal to grade 2 mucositis that has lasted for 24 hours and treated with systemic opioid

Exclusion Criteria:

* Patients in emergency ward -Patients having difficulties in understanding the study -
* Patients who have already been treated with oral morphine gel
Plasticity of Neonatal Neuronal Networks Temporal Theta Activity, the First Endogenous

Temporal theta slow-wave activity (TTA-SW) in premature infants is a specific signature of the early development of temporal networks, as it is observed at the turning point between non-sensory driven spontaneous local processing and cortical network functioning. The role in development and the precise location of TTA-SW remain unknown. Previous studies have demonstrated that preterms from 28 weeks of gestational age (wGA) are able to discriminate phonemes and voice, supporting the idea of a prior genetic structural or activity-dependent fingerprint that would prepare the auditory network to compute auditory information at the onset of thalamocortical connectivity. They recorded TTA-SW in 26-32 wGA preterms. The rate of TTA-SW in response to click stimuli was evalu- ated using low-density EEG in 30 preterms. The sources of TTA-SW were localized by high-density EEG using different tissues conductivities, head models and mathematical models.

Temporal theta slow-wave activity (TTA-SW) in premature infants is a specific signature of the early development of temporal networks, as it is observed at the turning point between non-sensory driven spontaneous local processing and cortical network functioning. The role in development and the precise location of TTA-SW remain unknown. Previous studies have demonstrated that preterms from 28 weeks of gestational age (wGA) are able to discriminate phonemes and voice, supporting the idea of a prior genetic structural or activity-dependent fingerprint that would prepare the auditory network to compute auditory information at the onset of thalamocortical connectivity. They recorded TTA-SW in 26-32 wGA preterms. The rate of TTA-SW in response to click stimuli was evalu- ated using low-density EEG in 30 preterms.

Eligibility Criteria:
Inclusion Criteria:

* healthy premature infants
* Gestational Ages of 26 and 32 wGA

Exclusion Criteria:

* unhealthy premature infants
Study of GBT021601 in Participants With Renal Impairment

Renal Impairment study of GBT021601.

This is a Phase 1, two-part, non-randomized, open-label, parallel group study to evaluate the PK, safety, and tolerability of GBT021601 following a single dose administration in adult participants with RI.

Eligibility Criteria:
Inclusion Criteria:

* Males or females, ≥ 18 years of age at the time of Screening.
* Have liver (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], and total bilirubin \[direct and indirect\]) and renal function tests, Hb, and hematocrit values within normal limits or are not clinically significant at Screening and Day -1 (Cohort 2 only).
* Has a stable renal function with no clinically significant change in renal status at least 1 month prior to study drug administration.

Exclusion Criteria:

* Any clinically significant medical history or abnormal findings upon physical examination, or clinical laboratory tests unrelated to their medical condition related to renal impairment, that might confound the results of the study or pose an additional risk in administering study drug to the participant.
* Evidence or history of clinically significant allergic (except for untreated, asymptomatic seasonal allergies at the time of study drug administration), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease unrelated to renal impairment.
The Use of International Ovarian Tumor Analysis and Assessment of Adnexal Neoplasia in Differentiating Malignant and Benign Adnexal Masses

All participants will be subjected to Serum measurements of CA-125 by the immunoradiometric assay, Ultrasound evaluation of the Adnexal masses which is described according to origin (ovarian/extraovarian); position (right/left/bilateral); number of lesions; type of lesions (unilocular/multilocular); size in three dimensions (longitudinal, anteroposterior and transverse diameters); intracystic fluid echogenicity; number of loculations; presence and size of septations (only thickest one of septations is considered); presence, number and size of solid papillary projections (largest thickness is considered); presence and size of the largest solid component (three diameters); presence and measurement of fluid volume in the posterior cul-de-sac and presence and location of lesions suggestive of metastases. Then surgical intervention will be done with pathological examination of the specimen

All participants will be subjected to Serum measurements of CA-125 by the immunoradiometric assay, Ultrasound evaluation of the Adnexal masses which is described according to origin (ovarian/extraovarian); position (right/left/bilateral); number of lesions; type of lesions (unilocular/multilocular); size in three dimensions (longitudinal, anteroposterior and transverse diameters); intracystic fluid echogenicity; number of loculations; presence and size of septations (only thickest one of septations is considered); presence, number and size of solid papillary projections (largest thickness is considered); presence and size of the largest solid component (three diameters); presence and measurement of fluid volume in the posterior cul-de-sac and presence and location of lesions suggestive of metastases. Then surgical intervention will be done with pathological examination of the specimen

Eligibility Criteria:
Inclusion Criteria:

* Women with clinically and sonographically diagnosed adenxal mass more than 5 cm in diameter. 2. Patients who will undergo surgical intervention . 3. Patients are recruited regardless of age, parity and complaint

Exclusion Criteria:

* Patients treated with conservative management. 2. Patients known to be pregnant.
Subclinical Hypothyroidism and Mind in the Elderly

Some recommendations of expert consensus on subclinical hypothyroidism (SH) are controversial in those areas with not enough information to reach a conclusion, such as not recommending treatment with thyrotrophic hormone of 4-10 mUI/L and free thyroxin in normal range. The body changes or symptoms at this stage are often mistaken as aging. There are studies showing significant changes in heart (slow rate, lower ejection fraction, diastolic dysfunction); hypercholesterolemia, dysfunction cognitive abilities (memory attention...).

The prevalence of SH increases with age, reaching 14% over 65 years old. This age group increase as the population ages highlights the need for evidence to improve recommendations for the elderly.

NEUROPSI is a validated neuropsychological test sensible for mild cognitive alterations. It can be applied to individuals with little schooling.

This study aims to determine positive change in cognitive abilities (NEUROPSI), ejection fraction, and body percent of lean and adipose tissue without adverse effects, placebo versus thyroxin supplement to keep thyroid-stimulating hormone (TSH) between 0.5-2.5 mUI/L in elderly with TSH 4-10 mIU/L.

Screening, subjects \> 59 y/o with out exclusion criteria to identify HS, started in October 15, 2008. Due to difficulties getting the placebo for the assay, by January halted the screening. At the end of May we got the donation from Merck pharmaceuticals.

The protocol original dates changed as follows:

* Restart screening June 20 to end in August 2009;
* Enrolling start at the end of June (the already identified);
* End enrolling October 2009;
* Follow up will end in May 2010.

Note: 150 of the screened subjects will be from randomly selected homes at Fomerrey 19 to allow prevalence estimation.

* Enroling ended until june 2010
* Follow up stil ungoing final measures will be done at the end of 2011

Eligibility Criteria:
Inclusion Criteria:

* TSH between 4 and 10 mUI/L inclusive

Exclusion Criteria:

* Known and treatment of thyroideal disease
* Arrythmia
* Anticoagulant treatment
* Dementia
* Disease leading to dementia (acv, LIVER....)
Investigating the Effect of Telmisartan (Micardis®) on the Average 24h Blood Pressure of Therapy-naive and Therapy-experienced Patients

Practical experience report (PER) investigating the effect of Micardis® on the average 24h blood pressure of therapy-naive and therapy-experienced patients


Eligibility Criteria:
Inclusion criteria:

1. Patients who have recently been diagnosed with hypertension
2. Patients whose current blood pressure treatment are inadequate and needs to be revised are suitable for inclusion.

Exclusion criteria:

None (according to investigator)
Family-Centered Rounds Checklist Implementation

The goal of this study is to develop, implement, and evaluate the effectiveness of an intervention designed to facilitate family engagement during bedside rounds at a children's hospital. The intervention consists of a "checklist" of key behaviors associated with the delivery of quality family-centered rounds, as well as training in the use of the checklist tool. In a pre-post controlled design, two hospital services will be randomized to use the checklist while two others will be randomized to usual care. The intervention is expected to increase to the performance of key checklist behaviors, family engagement, and family perceptions of patient safety.

Family engagement in children's healthcare encounters has been suggested as a means to improve safety. To engage families in care, the recommended practice is to conduct rounds at the child's bedside with the family present (family-centered rounds). Family-centered rounds strive to engage families in (1) a relationship with care providers, (2) exchange of information for decision making, and (3) deliberation about decisions. Bedside rounds represent a consistent venue to engage families in the care of hospitalized children, yet no studies have systematically identified and examined the barriers and facilitators of family engagement during rounds as a means to improve safety.

Eligibility Criteria:
Inclusion Criteria:

* Admitted as an inpatient on the pediatric hospitalist service, pulmonary service, or hematology/oncology service, during the study period.

Exclusion Criteria:

* Stigmatizing/sensitive reason for hospitalization (e.g., suspected non-accidental trauma or mental health concerns)
* New cancer diagnosis
* Parent(s) unable to speak or read English
* Parent(s) unavailable to consent (absent or sleeping during recruitment visits)
* Already participated in the study during a prior inpatient admission
A Prospective Study of Radiation Exposure to Surgeons

The purpose of this study is to measure the amount of radiation over a specific period of time that Orthopaedic Surgeons are exposed to while using the mini c-arm fluoroscopy machine.

The purpose of this study is to measure the amount of radiation over a specific period of time that Orthopaedic Surgeons are exposed to while using the mini c-arm fluoroscopy machine. The amount of radiation that the Surgeons will be exposed to will be recorded by a ring dosimeter located on the Surgeons' hand, and two badge dosimeters (one above the scrub collar, and one underneath a lead gown at waist level).

Eligibility Criteria:
This study will only enroll the Surgeons of the Vanderbilt Hand and Upper Extremity Center. There will be no inclusion/exclusion criteria for the type of surgery that will be monitored, nor the patients that are having surgery. If a mini c-arm fluoroscopy is used the amount of radiation received by the Surgeon's hand for that surgery will be monitored by a gas-sterilized radiation ring dosimeter. The amount of scatter radiation the Surgeon will be exposed to will be recorded by a badge dosimeter located on the Surgeon's scrub collar, and one badge dosimeter that will be located under the required lead gown worn by the Surgeon.
A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors

The purpose of this study is to investigate the efficacy and safety of BGB-16673 compared with investigator's choice (idelalisib plus rituximab or bendamustine plus rituximab or venetoclax plus rituximab retreatment) in participants with chronic lymphocytic leukemia (CLL) previously exposed to both BTK inhibitors (BTKi) and BCL2 inhibitors (BCL2i).

Chronic lymphocytic leukemia is a type of blood cancer that affects people around the world. People with CLL suffer from enlarged lymph nodes, spleen, or liver, or have symptoms like night sweats, weight loss and fever. They have shorter life expectancy compared to healthy people. There is an urgent need for new treatment to prolong life and control disease-related symptoms.

In this study, participants with relapse/refractory (R/R) CLL who were previously exposed to a BTKi and a BCL2i will receive BGB-16673 or the investigator's choice of idelalisib plus rituximab or bendamustine plus rituximab or venetoclax plus rituximab retreatment. The main purpose of this study is to compare the length of time that participants live without their CLL worsening between those participants who receive BGB-16673 versus the investigator's choice of treatment (idelalisib plus rituximab or bendamustine plus rituximab, or venetoclax plus rituximab).

Approximately 250 participants will be included in this study around the world. Participants will be randomly allocated to receive either BGB-16673 or the investigator's choice of treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed diagnosis of CLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria.
2. Previously received treatment for CLL with a BTKi and BCL2i.
3. Measurable disease by computer tomography/magnetic resonance imaging
4. Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2
5. Adequate liver function
6. Adequate blood clotting function

Exclusion Criteria:

1. Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
2. Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy in the last 3 months
3. Known central nervous system involvement
4. Prior exposure to any BTK protein degraders
5. Active fungal, bacterial and/or viral infection requiring parenteral systemic therapy
6. Clinically significant cardiovascular disease

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.