cyrilzakka/clinical-trials huggingface dataset:
Safe Threshold to Discontinue Phototherapy in Hemolytic Disease of Newborn

We hypothesized that adopting a lower rather than a higher threshold for phototherapy discontinuation will be associated with reduced rates of rebound hyperbilirubinemia in term and late preterm neonates with hemolytic disease of newborn.

Objectives: The investigators aimed to compare the safety of implementing low-threshold, compared to high- threshold, of TSB for phototherapy interruption in term and late preterm neonates with hemolytic disease of newborn.

Neonates in high-threshold group phototherapy will be ceased if TSB level is 50-100 µmol/L below the appropriate 2004 AAP phototherapy threshold, whereas neonates in the low-threshold group phototherapy will be stopped if TSB reached ˃100 µmol/L below the AAP threshold.

Phototherapy will be commenced for neonates in both groups according to AAP guidelines.Neonates will be treated with intensified overhead blue LEDs phototherapy if they have a TSB level at or above phototherapy threshold. Neonates will be started on intensified 360◦ LED phototherapy if they have TSB level within 50µmol/L below the exchange threshold. The administration of IVIG is indicated in infants with isoimmune hemolytic disease if TSB lies within 34 to 51 micromol/L of the threshold for exchange transfusion and not responding to initial intensified phototherapy.Infants with a TSB concentration above the thresholds for exchange should have immediate intensified 360◦ LED phototherapy, and preparation for exchange transfusion will be started.Infants showed clinical signs of acute bilirubin encephalopathy will have an immediate exchange transfusion.

Eligibility Criteria:
Inclusion Criteria:

Healthy term and late-preterm neonates more than or equal 35 weeks gestation with hemolytic disease of newborn will be included. Enrolled infants should have evidence of hemolysis as defined by any of the following criteria:

1. positive DAT and blood group iso-immunization (ABO / RH incompatibility);and /or
2. HGB decline by 2g/dl within 24hour.

Exclusion Criteria:

* Major congenital abnormalities,
* Surgical problems,
* Direct hyperbilirubinemia
* Sepsis
Mindfulness and Maternal Mental Health

There is preliminary empirical support for the use of mindfulness interventions during the perinatal period; suggesting that mindfulness training may be an effective treatment approach for reducing depression and anxiety symptoms during pregnancy and reducing anxiety, stress, and psychological distress during the postpartum period. To extend on these findings, the purpose of this research is to evaluate the effectiveness of a brief mindfulness-based program in protecting maternal mental health and well-being using a randomized controlled trial.

Based on the results reported in the existing literature that show that formal mindfulness-based practice is effective for improving mental health status and preventing depressive symptom relapse, this research aims to evaluate the effectiveness of a brief mindfulness-based program, offered during pregnancy, in reducing mothers' psychological symptoms during pregnancy and the postpartum period. A brief program has the advantage being more economical to facilitate compared to full-length programs and also requires a shorter commitment from pregnant women, who are also attempting to manage multiple other new and existing demands (e.g., obstetrics appointments, work).

As emerging research suggests that women are particularly vulnerable to increased depressive, anxious, obsessive, compulsive, and hypomanic symptoms during the perinatal period these are the main psychological symptoms that will be assessed. As well, perceived stress and psychological resiliency will also be assessed for in order to examine changes in these domains in relation to mindfulness engagement. Furthermore, as a reduction in maternal psychological symptoms has been reported to have implications for mother-infant bond, the mother's interpersonal functioning, and maternal quality of life, the investigators will also assess to see if there are corresponding changes in these domains related to mindfulness engagement.

Eligibility Criteria:
Inclusion Criteria:

* pregnant, age 18 years and older, able and willing to attend the study site for the four group sessions.

Exclusion Criteria:

* presence of a current severe mental health condition or mental heath difficulties that would be better addressed through another form of therapy, active major medical illness including significant obstetric complications, inability to give informed consent, inability to speak or understand English, at high risk for delivery before reaching full term (38 weeks gestation), or previous completion of a structured mindfulness-based program.
A Comparison of Pain Scales in Patients With Disorder of Consciousness Following Craniotomy

This study aims to test validity, reliability and practicality of translated NCS, CNPI and FLACC in unconscious patients in 48 hour following craniotomy.

This study aims to test predictive validity (sensitivity and specificity), content validity, concurrent validity, construct validity, inter-rater reliability and practicality of translated Nociception Coma Scale (NCS) , Checklist of Non Verbal Pain Indicator (CNPI) and the Faces, Legs, Activity, Cry, Consolability Observation Tool (FLACC) in unconscious patients in 48 hour following craniotomy.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years old
2. Preoperative intracranial lesion which predicts delayed recovery
3. Disorder of consciousness within 48 hours after craniotomy assessed by using Coma Recovery Scale-Revised (CRS-R) 17
4. Not received postoperative sedation or muscle relaxants

Exclusion Criteria:

1. Documented history of prior brain injury
2. History of delayed development
3. Prior psychiatric illness
4. Prior neurological illness
5. Superior limb contusion, fracture, paralysis -cannot move
6. Thalamic hemorrhage -cannot express feeling
Potential Adverse Developmental and Nutritional Consequences of Helicobacter Pylori Infection in Israeli Children

The investigators believe that there is an association between H. pylori infection and nutritional status and between H. pylori infection and cognitive development. The current study will examine this association in Israeli children, aged 6-12 years.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent by parents/guardians and children

Exclusion Criteria:

* Growth retardation history
* History of prior therapy for H. pylori irradiation
* Hematological disorders
* Developmental delays
Pain Relief Investigation of NeuroModulation Therapy in Adult Humans

The study is being performed to determine the efficacy and safety of Fralex Neuromodulation Therapy (F-NMT), delivered by the Fralex PRIMA device, in reducing chronic musculoskeletal pain.


Eligibility Criteria:
Women's Estrogen/Progestin Lipid Lowering Hormone Atherosclerosis Regression Trial (WELL-HART)

To determine the effects, in postmenopausal women, of hormone replacement therapy on progression/regression of coronary heart disease, as measured by quantitative angiography.

BACKGROUND:

The trial was a logical extension of preceding observational and cross-sectional studies on estrogen replacement therapy. Overall, the studies suggested a 50 percent reduction in risk of coronary heart disease in current estrogen users compared to non-users. In spite of such striking findings, most studies had been prone to a number of biases. One major criticism of observational studies had been that women receiving estrogen were generally healthier and more compliant than non-estrogen users.

There was a very large body of observational data suggesting that the use of estrogen in postmenopausal women reduced coronary heart disease mortality by approximately 45 percent. At the same time, there had been some concern that replacement therapy increased the likelihood of uterine cancer and perhaps breast cancer as well, although it was generally accepted that this risk was probably significantly less than the benefits obtained from the reduction of coronary heart disease mortality.

DESIGN NARRATIVE:

Randomized, double-blind, placebo-controlled. After baseline angiograms, patients were randomized to one of three arms: micronized 17-beta estradiol, 1 milligram per day; 17-beta estradiol plus medroxyprogesterone, 5 milligrams per day for twelve days per month; and placebo. Subjects in all three arms received lipid-lowering therapy, low fat/low cholesterol diet, and the HMG-CoA reductase inhibitor, pravastatin, in sufficient dosage to reduce low density lipoprotein (LDL) cholesterol levels below 130 mg/dl. The primary endpoint was progression/regression of coronary obstructive disease as measured by angiography, including the expert human panel and quantitative computer analysis. The secondary endpoint was carotid media-intima thickness determined by ultrasound. Clinical measures included lipids, lipoproteins, apolipoproteins, estradiol and medroxyprogesterone levels, urinary prostanoid metabolites, and insulin/glucose metabolism. Subjects were recruited at three centers with active coronary angiography units. Several core facilities supported the study: a Core Lipid Lab, a Reproductive Endocrine Lab, the Biostatistics Lab (Data Coordinating Center) and the Angiographic Imaging Laboratory.

The study completion date listed in this record was obtained from the "Completed Date" entered in the Query View Report System (QVR).

Eligibility Criteria:
Postmenopausal women with angiographically-documented coronary disease. Approximately 70 percent minority
Transpulmonary Pressure in One Lung Ventilation and Open Pneumothorax

Esophageal Pressure During one lung ventilation

Esophageal pressure comparison during positive pressure ventilation, one lung ventilation, lateral position and open pneumothorax

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for VATS requiring one lung ventilation
* Body mass index below 35 kg/m\^2

Exclusion Criteria:

* esophageal pathology preventing insertion of orogatric tube
* scoliosys
Partnerships to Improve Lifestyle Interventions (PILI) 'Ohana Dissemination Project

The purpose of the OHA PILI 'Ohana Project is to disseminate and evaluate the effectiveness of a community-based intervention (PILI 'Ohana Intervention Program) aimed at eliminating obesity in Pacific Peoples across the four islands. Dissemination will involve implementation of the program in eight communities through partnerships with nine different community-based organizations serving those areas (four founding community partners and five new community partners). These organizations provide services to a large number of Pacific Peoples, including (but not limited to) Native Hawaiians, Samoans, Filipinos, and Chuukese.

The main aims are to: (1) train five additional community organizations and their staff to deliver the PILI 'Ohana Intervention Program, (2) to enroll 150 overweight/obese participants across 8 different communities and four different islands into the intervention program, and (3) to evaluate the effectiveness of the program in reducing weight/BMI by at least 3% of the participant's initial weight.

The PILI 'Ohana Intervention is a 9-month lifestyle intervention focusing on individual health behaviors in the context of family and community environments and in the socio-cultural context of Pacific Peoples. In order to increase the likelihood that an organization will implement the PLP, they will be able to adapt the intervention and participant assessments. The POP will provide guidance on adaption of the intervention and assessments at the training (CHS #21680). What is described below is the maximum amount of contact and assessment procedures that participants will undergo. Therefore, organizations may change the timing of the 14 lessons and refrain from using all the assessment procedures, but will still provide the 14 lessons and offer the same incentives to participants for assessments.


Eligibility Criteria:
Inclusion Criteria:

* BMI greater than or equal to 25
* Clients and/or residents of communities served by 9 partnering community organizations

Exclusion Criteria:

-
Safety of Pregnancy in BRCA Mutated Breast Cancer Patients

The present study aims at refining the understanding of the effect of pregnancy on breast cancer outcomes in the specific population of BRCA mutated patients with known history of breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of invasive breast cancer between January 2000 and December 2020;
* Breast cancer diagnosis at the age of ≤ 40 years;
* Known presence of germline BRCA mutation.

Exclusion Criteria:

* Known BRCA mutation with no diagnosis of invasive breast cancer;
* Diagnosis of ovarian cancer or other malignancies with no history of invasive breast cancer;
* Diagnosis of hereditary or familiar invasive breast cancer without BRCA mutation or with BRCA genes not tested;
* Diagnosis of invasive breast cancer with germline BRCA variants of unknown significance.
Active Video Game Influence Cognitive Ability

The experiment was conducted at the Human Biomechanics Laboratory of the College of Applied Medical Sciences of Prince Sattam bin Abdulaziz University between February 2024 and May 2024. During the briefing, all questions were answered to ensure that participants understood the experiment and its objectives. On the day of the experiment, demographic information was collected, including age, height, weight, body mass index (BMI), and preferred leg. An Eye-Level Weight Beam scale (Detecto, Webb City, MO, USA) was used to determine the weight and height of the subjects. To identify the preferred leg, participants were observed ascending stairs or kicking a ball.

Participants were recruited and assigned to one of two groups, either the control group or the VR group. Participants were required to attend one experimental session in a random order using Microsoft Excel's (Microsoft Corp., Redmond, WA, USA) random list function. The VR group was required to play a 20-minute game of Beat Saber VR, while the control group was asked to sit quietly for 20 minutes without any activities assigned. This study used an accelerometer from ActivPal (PAL Technologies Ltd, Glasgow, UK) to capture the PA levels of the VR group throughout the VR game. Following previously published validation studies and manufacturer recommendations, a strip of Tegaderm (3M, St. Paul, MN) was attached to the preferred leg's front thigh.


Eligibility Criteria:
Inclusion Criteria:

* Female college students
* Low physical activity (inactive)
* Age (18 to 23 years)
* No previous medical condition affecting PA level
* No visual impairments
* Have never experienced the VR game used in the trial

Exclusion Criteria:

* Male students
* Physically active
Development and Evaluation of an Online Multidimensional Musculoskeletal Health Programme

Globally, work-related musculoskeletal symptoms (WRMSs) have become one of the major public health issues, with musculoskeletal problems contributing to the largest proportion of lost work productivity. Literature has reported that grassroots working-class workers (also known as low-skilled workers) are the most vulnerable group to WRMSs as their work mostly exposes them to the identified risk factors. However, not many intervention studies have been conducted for low-skilled workers to prevent WRMSs.

Based on the concept of the multidimensional approach from the literature, and the project team's previous evidence-based research results, this project will modify the project team's face-to-face evidence-based musculoskeletal health promotion program to an online mode with 4 weekly 45-minute workshops for low-skilled workers in the community under the Covid-19 pandemic situation. Thus, the project has the following specific objectives:

(i) To determine the feasibility of conducting the proposed online program (ii) To examine the acceptability and satisfaction of the online program from the workers' perspectives (iii) To evaluate the potential effects of the online program on the primary outcomes: compliance with exercise regimes, improvement of musculoskeletal literacy, and reduction of the number of body parts with WRMSs (iv) To evaluate the potential effects of the online program on the secondary outcomes: reduction of adverse workstyle, improvement of exercise self-efficacy, mental health, body mass index, hip-waist ratio, and blood pressure measurements


Eligibility Criteria:
Inclusion Criteria:

* low-skilled workers aged ≥ 18
* working full-time or part-time,
* with at least one body part that had been affected by WRMSs for at least one month.

Exclusion Criteria:

* engagement in WRMS prevention programs in the workplace at the time of the study,
* undergoing medical treatment
1.2% Rosuvastatin Gel As A Local Agent In Smokers With Chronic Periodontitis

The purpose of the present study was to evaluate the effects of subgingival delivery of Rosuvastatin gel as an adjunct to scaling and root planing in Smokers With Chronic Periodontitis (CP) patients.

Background: Periodontal diseases are multi-factorial in etiology, and bacteria are one among these etiologic agents. However, mechanical therapy itself may not always reduce or eliminate the anaerobic infection at the base of the pocket, within the gingival tissues. To overcome this, various systemic and local drug delivered antimicrobials have been used as an adjunct to scaling and root planing (SRP).The present study aims to explore the efficacy of 1.2% rosuvastatin (RSV) gel local drug delivery as an adjunct to SRP in smokers with chronic periodontitis (CP).

Methods: Sixty subjects were randomly allocated into two treatment groups: SRP with placebo gel (group 1), SRP with 1.2% RSV gel (group 2). Clinical parameters were recorded at baseline, 6 and 9 months. Radiographic assessment was done using computer aided software at baseline, 6 and 9 months.

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy CP subjects aged between 30-50 years who are current smokers with no history of periodontal therapy or use of antibiotics in past 6 months, having sites with intrabony defect depth (IBD) ≥ 3mm (distance between alveolar crest and base of the defect on intraoral periapical radiograph) along with PPD ≥5 mm or CAL ≥3 mm in an asymptomatic tooth were included in the study.

A subject was considered as a current smoker if he regularly smoked more than 10 cigarettes/day for a minimum of 5 years

Exclusion Criteria:

* Former smokers, i.e. subjects who had previously been smokers but stopped their habit, and non-smokers were excluded. Subjects allergic to statins, on systemic statin therapy, with any known systemic disease or any other systemic inflammation/ infection which could alter the course of periodontal disease and users of tobacco in any other form than cigarettes were excluded from the study
Observational Study in Real Life to Describe the Libicare® Effectiveness in Female Sexual Dysfunction.

The decrease or absence sexual desire and arousal is the alteration of the sexual sphere that women most commonly refer to in adulthood and old age. Many women can refer a decrease or absence of desire and / or arousal without having the disorder typified in the DSM-5, but that can cause discomfort, worry and relationship problems in their day to day. Libicare® is a food supplement whose ingredients could have positive effects on the improvement of sexual function in women with low desire and arousal levels. The main ingredients of Libicare® are:

* Trigonella Foenum-graecum (Trigonella) (1)
* Tribulus Terrestris (Tribulus) (2)
* Turnera Diffusa (Damiana) (3)

The main objective is to describe the effectivity of LIBICARE® in the improvement of desire and sexual arousal in women between 45 and 65 years old, in real life.

The secondary objectives of the study are:

* Evaluation of the 6 domains of the EVAS-M scale at 2 and 4 months of treatment.
* Assessment of the safety of LIBICARE® by collecting serious and non-serious adverse events.
* Evaluation of patient satisfaction with treatment at 2 and 4 months of treatment.
* Therapeutic compliance in taking the food supplement at 2 and 4 months of treatment.
* Study of the hormonal variation in relation to the values of total testosterone, free testosterone and SHBG, at the beginning, at 2 months and at 4 months of treatment, in those patients in which it is determined by routine clinical practice.
* To evaluate the degree of usefulness of the EVAS-M scale in clinical practice after 4 months of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Women between 45 and 65 years old, both ages included.
* Women who refer decreased desire and / or sexual arousal.
* Women who will receive LIBICARE® by prescription of their doctor regardless of their participation or not in the study.
* Women who have given their informed consent in writing.

Exclusion Criteria:

* Women who suffer or have suffered breast cancer.
* Women in anticoagulant treatment.
* Women who, in the opinion of the researcher, cannot follow the study procedures.
* Women not be able to understand the nature of the study, the procedures to follow or who are not authorized to sign an informed consent
* Pregnant or lactating women
* Women with allergies to any of the components of Libicare®
A Patient Handling Study of Mometasone Furoate/Formortoral Fumarate (MF/F) Metered Dose Inhaler (MDI) With an Integrated Dose Counter in Adolescent and Adult Subjects With Asthma or Chronic Obstructive Pulmonary Disease (Study P04703AM1)

This was an open-label, multiple-dose, study of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 micrograms (mcg) twice daily (BID) (2 puffs of MF/F MDI 50/5 mcg, administered twice a day approximately 12 hours apart) in participants 12 years of age or older, with a diagnosis of persistent asthma or chronic obstructive pulmonary disease (COPD) of at least 12 months. The primary purpose of the study was to evaluate the performance of the MF/F MDI integrated dose counter under normal patient handling conditions.


Eligibility Criteria:
Diagnosis and Criteria for Inclusion:

* A participant must have been at least 12 years of age, of either sex, and of any race, with a diagnosis of persistent asthma or COPD of at least 12 months.
* A participant must have been able to demonstrate correct use of an MDI without a counter at the Screening Visit.
* A participant must have demonstrated at least 90% compliance with completion of the e-diary, use of the counterstrip, and use of the study medication over the 2-week Screening Period.

Exclusion Criteria:

* Participants with a serious uncontrolled medical disorder, which in the judgment of the investigator, could have interfered with the study, or required treatment which might interfere with the study.
* Participants who in the judgment of the investigator and/or sponsor had a significant recent or current, repetitive strain injury (RSI) that may have impacted their ability to effectively participate in the full duration of the study.
Study of Combination Therapy With LdT Plus Adefovir Versus Adefovir Alone

This study is being conducted to compare the safety and effectiveness of the investigational medication LdT (telbivudine) used in combination with adefovir dipivoxil (a drug currently approved by the Food and Drug Administration \[FDA\] for the treatment of hepatitis B virus \[HBV\]) versus adefovir dipivoxil used alone. The results for patients taking the combination therapy will be compared to the results for patients taking adefovir alone.


Eligibility Criteria:
Inclusion Criteria:

* Documented compensated chronic hepatitis B defined by a clinical history compatible with chronic hepatitis B.
* Previous or current lamivudine treatment
* HBV DNA \> 6 log10 copies/mL
* Evidence of viral breakthrough

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Patient is pregnant or breastfeeding.
* Patient is co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV.
* Patient has received any anti-HBV treatment for HBV infection other than lamivudine in the 12 months before Screening for this study.

Other protocol-defined exclusion criteria may apply.