cyrilzakka/clinical-trials huggingface dataset:
Glycerin Suppositories Used Prophylactically in Premature Infants (SUPP): a Pilot Randomized Placebo-controlled Trial

All premature babies have problems with feeding and nutrition. Some can develop a life-threatening bowel infection necrotizing enterocolitis. This can result in the need for emergency surgery, loss of bowel, lifelong feeding problems, and death. Giving premature babies glycerin suppositories may be one way to stimulate the digestive tract and help prevent these problems. To see if this treatment works, the investigators need to study hundreds of premature babies in a large trial involving multiple hospitals. The purpose of this project is to carry out a small study first and make sure that the larger trial is feasible. The investigators will invite approximately 30 premature babies from the Neonatal Intensive Care Unit at McMaster University Medical Centre to participate in this study over a 6-month period. The investigators will focus on feasibility issues, including cost, safety, and rate of participation. This will allow us to rigorously test our study protocol and lay the groundwork for the larger study involving multiple hospitals.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age 24-32 weeks OR
* Birth weight 500-1500 grams

Exclusion Criteria:

* Congenital gastrointestinal anomalies
* Surgery within 48 hours of birth
* Culture-proven sepsis\*
* Vasopressors within 6 hours of first intervention
* Nitric oxide
* Duct-dependent congenital heart defect requiring prostaglandins
* Suspected coagulopathy (mucosal bleeding from any orifice)
* Confirmed coagulopathy (any one of the following):
* International Normalized Ratio greater than 1.4
* Partial Thromboplastin Time greater than 39 seconds
* Fibrinogen less than 1.00 grams/liter
* Thrombocytopenia (platelet count less than 100 x 10\^9/liter)\*\*
* Neutropenia (absolute neutrophil count less than 0.5 x 10\^9/liter)
* Complete meconium evacuation (2 normal bowel movements) within 48 hours of life
* Parent or legal guardian unable to understand English

Note:

\* C-reactive protein is not an exclusion criteria

\*\* Indomethacin alone is not an exclusion criteria
Post-eRADicAte - A Long Term Follow up of Subjects That Completed the eRADicAte Study (NCT 02097303)

This is a Long Term Follow Up study to eRADicAte, an open label study designed to examine the effects of Radium Ra 223 dichloride with concurrent administration of Abiraterone Acetate plus Prednisone Castrate-Resistant (Hormone-Refractory) Prostate Cancer subjects with symptomatic bone metastasis.

This is a Long Term Follow Up study to eRADicAte, an open label study designed to examine the effects on concurrent administration of Radium Ra 223 dichloride and Abiraterone Acetate plus Prednisone in subjects with symptomatic castrate resistant prostate cancer and with bone metastases.

31 subjects completed all study visits in the eRADicAte study, and were thus evaluable. All 31 subjects will be asked to participate in this Long Term Follow Up study which will evaluate overall survival, subsequent additional prostate cancer therapies and medications, radiographic changes and SSE's (Symptomatic Skeletal Events), incidence of bone marrow failure, and diagnosis with secondary malignancies.

Living subjects will be evaluated at least 12 weeks after their last dose of Radium Ra 223 dichloride and at each subsequent clinic visit. Deceased subject's data will be obtained retrospectively, from 12 weeks after the eRADicAte End of Treatment visit and prospectively through the date of death. The total duration of the study is expected to be 48 months

Eligibility Criteria:
Inclusion Criteria:

* Eligible subjects are adults over the age of 18 with mCRPC that completed the eRADicAte study. The living study subject or legally authorized representative must be able to understand and sign the written informed consent form.

Exclusion Criteria:

* A living study subject or his legally authorized representative are not able to understand or willing to sign the written informed consent form.
Pyruvate Kinase (PK) Deficiency Global Longitudinal Registry: Patient-Reported Outcomes (PRO)

The primary objective of this study is to understand and characterize the health-related quality of life (HRQoL) and disease burden of adult participants with PK deficiency receiving routine clinical care. This study is an observational (i.e., noninterventional), longitudinal, multicenter, global registry for participants with PK deficiency, a rare nonspherocytic hemolytic anemia.

This study will be open for enrollment for 2 years and all enrolled participants will be followed prospectively for up to 96 weeks.

Data will be collected from participants who have provided informed consent and authorization pursuant to applicable laws and regulations.

Participants aged ≥18 years and previously enrolled in Study AG348-C-008 (NCT03481738) will be eligible to participate in this study. Data will be submitted via electronic patient-reported outcomes (ePRO) application.

All data collection efforts will abide by this protocol and be prospectively disclosed in the study informed consent. This study, with the appropriate participant (and or parent/guardian) consent/assent, may incorporate retrospective data from other properly consented studies done for the purpose of examining the longitudinal natural history of PK deficiency.

Eligibility Criteria:
Inclusion Criteria:

* Participant must be greater than or equal to (≥)18 years of age;
* Participant must be enrolled in Study AG348-C-008.

Exclusion Criteria:

- Participant is enrolled in an Agios-sponsored clinical study involving treatment with a pyruvate kinase activator.
Electromyographic Evaluation of the Efficacy of Manual Therapy in Temporomandibular Joint Dysfunction.

Individuals with temporomandibular joint dysfunction (TMD) may experience changes in muscle activation as a result of symptoms such as pain and limitation of movement. The aim of this study is to examine the efficacy of manual therapy electromyographically in patients with TMD.

TMD is a common condition in the community. It may occur due to factors such as trauma, stress, occlusal disorders. Symptoms include pain, limitation in mouth opening, joint voice, postural and psychosocial disorders. TMD/RDC diagnostic criteria are used in the classification of TMD, and accordingly, it is stated that it may originate from the joint, disc and chewing muscles. In the treatment, conservative treatments such as patient education, manual therapy and exercises are applied first.

Manual therapy is an effective physiotherapy method on pain and muscle dysfunctions in musculoskeletal problems. In our study, electromyographic changes of masticatory muscles will be examined by applying manual treatment to the masticatory muscles and cervical region in myofascial TMD patients according to TMD/RC.

Eligibility Criteria:
Inclusion Criteria:

* No cognitive impairment
* Diagnosed with temporomandibular joint(TMJ) dysfunction of myofascial origin,
* Volunteers aged 18-65

Exclusion Criteria:

* Malignancy and fracture of the cervical region and/or TMJ
* Active infection
* Patients actively receiving cervical and/or TMJ-related therapy
Early Feeding vs 5-day Fasting After Distal Elective Bowel Anastomoses in Children. A Randomized Controlled Trial

Purpose:

To determine the safety and efficacy of early enteral feeding after distal (ileum-colon) elective bowel anastomoses in children.

Methods:

Controlled randomized trial including all pediatric patients with distal elective bowel anastomosis, excluding non-elective and high risk patients. VARIABLES:

Demographic characteristics, operative time, anastomosis placement,

Follow up: Tolerability variables: beginning peristalsis, beginning bowel movement, time to full diet intake, post-operative stay. Safety variables: mild and persistent vomiting, persistent abdominal distention, wound infection or dehiscence as well as anastomotic leak or dehiscence, reoperation and death. At the end of surgery were randomized to:

1. Experimental group(EG): Early feeding group, after a 24 hours fasting period, with good abdominal conditions (once the post operative ileus had solved), oral fluids and diet was started.
2. Control group (CG): obligatory 5-day fasting. Once the regular diet was tolerated, the patients were discharged. Statistics: Descriptive statistics for global description. Student's t test for quantitative variables and Chi square test for qualitative variables, a p-value less than 0.05 was considered statistically significant.


Eligibility Criteria:
Inclusion Criteria:

* All patients between the ages of 1 month to 18 years old that required elective laparotomy with a distal elective bowel anastomosis (ileum and colon).

Exclusion Criteria:

* Proximal and non elective anastomosis
* High risk groups:
* Newborns
* Upper gastrointestinal tract anastomosis (esophagus, gastric, duodenal or jejunal)
* Bilious-digestive or rectal anastomosis
* Immunosuppressed patients
* Gastrostomy or any pre anastomotic derivation
* Multiple anastomoses
* Chronic intestinal obstruction
* Patients who did not complete the minimum POP follow up of one month.
Psychological Impact, Mental Health and Sleep Disorder Among Patients Hospitalized and Health Care Workers During the 2019 Coronavirus Outbreak (COVID-19)

COVID-19 is an infectious disease caused by the last coronavirus discovered, called SARS-CoV-2. Symptoms encountered in COVID-19 are: cough, breathing difficulties (dyspnea, chest pain, etc.), pyrexia, anosmia (loss of smell) and/or dysgeusia (loss of taste), but also ENT symptoms (rhinitis type, odynophagia), headaches, asthenia, muscle pain, confusion and diarrhea. Infection with SARS-CoV-2 can also be asymptomatic. COVID-19 can be passed from person to person by respiratory droplets expelled when a person speaks, coughs or sneezes. The currently estimated incubation period ranges from 1 to 14 days, and most often this is around 5 days.

According to a literature review, there is strong evidence that COVID-19 has an impact on mental health (anxiety being the most common symptom) whether in the general population, healthcare workers or vulnerable populations. The objective of this project is to assess mental health and sleep disorders within two populations: elderly patients and nursing staff.


Eligibility Criteria:
Inclusion Criteria:

* Subjects 65 years of age or older, having been hospitalized for COVID-19 within the CHU Brugmann Hospital
* People aged 18 or over, member of the nursing staff of the CHU Brugmann Hospital, having worked during COVID-19.

Exclusion Criteria:

* Incoherent patients
* Severe presbycusis
* Oral expression impairment
* Insurmountable language barrier
A Clinical Study on Fasudil Hydrochloride for Treatment of Gene-Specific Ovarian Cancer

This is a prospective study investigating whether the research on Fasudil Hydrochloride in the treatment of gene-specific ovarian cancer can be applied to predict sensitivity to immunotherapy in non-small cell lung cancer (NSCLC) and other tumors. The study plans to enroll 20 patients with A/A genotype ovarian cancer for treatment evaluation.

Ovarian cancer is a common gynecological malignancy with the highest mortality rate among gynecological cancers. The poor prognosis and low survival rate in advanced-stage patients primarily contribute to its high mortality. Current clinical management of malignant ovarian tumors relies on postoperative chemotherapy and radiotherapy, which impose significant harm to the human body and offer limited improvement in patient prognosis. Additionally, the diagnostic and therapeutic cycle for malignant ovarian cancer is prolonged and unpredictable, predominantly focusing on post-surgical interventions.

In our preliminary studies, we identified that the A allele of SNP-rs1192691, associated with ovarian cancer prognosis, promotes ovarian cancer cell proliferation and invasion by activating the Rho signaling pathway. The Rho signaling pathway inhibitor Fasudil has been shown to effectively suppress the proliferation and invasion of A/A genotype tumor cells in murine models. This study aims to investigate the therapeutic efficacy of Fasudil in A/A genotype ovarian cancer patients through clinical trials, with the goal of improving their prognosis.

Eligibility Criteria:
Inclusion Criteria:

1. Patients voluntarily participate in the study, sign informed consent forms, and have good compliance.
2. After platinum based chemotherapy at Zhejiang Provincial People's Hospital, the efficacy evaluation showed that ovarian cancer patients who achieved disease stability (SD) or disease progression (PD) twice were treated with Fasudil in combination with the original chemotherapy regimen, and were confirmed to have the A/A genotype through genetic testing.

Exclusion Criteria:

* 1.Accompanied by hypotension 2. Bleeding like cerebral hemorrhage 3. Patients with abnormal liver function
The Psychological Impact of the COVID-19 on Students.

The COVID-19 outbreak has been rapidly transmitted in late January 2020 and aroused enormous attention globally. The public at large may also experience boredom, disappointment, and irritability under the isolation measures. Depression and anxiety are common mental health problems experienced by university students. This survey aims to investigate the psychological impact of COVID 19 on students.

The COVID-19 outbreak has been rapidly transmitted in late January 2020 and aroused enormous attention globally. Infected patients may develop severe and even fatal respiratory diseases (e.g., acute respiratory distress syndrome (ARDS) and acute respiratory failure) ending up in intensive care. Apart from physical suffering, it is not uncommon for confirmed or suspected cases of COVID-19 to suffer from great psychological pressure and other health-related problems. The limited knowledge of the COVID-19 and the overwhelming news may lead to anxiety and fear in the public. The public at large may also experience boredom, disappointment, and irritability under the isolation measures.

Depression and anxiety are common mental health problems experienced by university students. Being in higher education is associated with many stressors and transitional events, and students fall within the age range when common mental health problems are at their developmental peak. Depression and anxiety can impair students' academic performance and social functioning, cause significant burden at university, and potentially affect their future career opportunities. The study includes 2 parts. Part A is an online survey study with non-probabilistic convenience sampling and part B is focus group interviews.

This study aims to explore the psychological impact of COVID-19 and coping methods in higher education students.

Eligibility Criteria:
Inclusion Criteria:

• Higher education students aged 18 years and above

Exclusion Criteria:

• Subjects refuse to answer this questionnaire
Comparison of Retinol 1.0% and Tretinoin 0.02% in the Treatment of Moderate to Severe Photodamage and Wrinkles

The purpose of this study is to assess the comparative efficacy of retinol 1.0% and tretinoin 0.02% in minimizing wrinkles, discoloration, roughness, and other signs of moderate to severe photodamage. Our hypothesis is that both products will be of comparable benefit.


Eligibility Criteria:
Inclusion Criteria:

* Age 35 or over
* Moderate to severe photodamage

Exclusion Criteria:

* History of facial cosmetic surgery, facial resurfacing procedures, deep peels, or facial fillers
* History of keloids or hypertrophic scars
* Use of oral steroids or oral retinoids (such as Accutane) in past 6 months
NAD Supplementation and Vascular Health in PAD

This pilot open-label clinical trial was designed to investigate whether 4-week supplementation with 1g daily NR impacts endothelial function in peripheral circulation, cerebrovascular hemodynamics, cognitive function in older adults with peripheral artery disease.

Peripheral artery disease (PAD) is a prevalent age-related vascular pathology and the third leading cause of cardiovascular morbidity and mortality among older adults. Accumulating evidence indicates that PAD is associated with generalized endothelial dysfunction that expands from the periphery to central circulation and from macro- to microcirculation. One of the mechanisms that contributes to vascular dysfunction in aging and age-related diseases is the decline in the Nicotinamide Adenine Dinucleotide (NAD) levels. Importantly, recent reports indicate that age-associated decreases in NAD are exacerbated in age-related diseases, including in patients with PAD. Clinical data demonstrate that NAD levels can be increased via per os supplementation with the NAD precursor nicotinamide riboside (NR). Although few ongoing studies provide initial evidence that NAD supplementation with NR may benefit vascular health in older adults, including potential improvements in blood pressure and aortic stiffness, the effects of NR supplementation on vascular health in PAD is understudied. This pilot open-label clinical trial was designed to investigate whether 4-week supplementation with 1g daily NR impacts endothelial function in peripheral circulation, cerebrovascular hemodynamics, cognitive function in older adults with peripheral artery disease.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of PAD
* intermittent claudication
* limited walking capacity

Exclusion Criteria:

* macologically uncontrolled type 2 diabetes, hypercholesterolemia, hypertension
* major depressive disorder
* current or prior cerebrovascular complications (including large vessel ischemic stroke with chronic functional impairment)
* neurodegenerative diseases
Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2018_16

An EEG study using continuous speech stimuli to assess neural language processing in a hearing impaired population. Participants listen to short radio excerpts in different Signal to Noise Ratios (SNR) and answer comprehension questions as well as listening effort questions. We assess the effect of different algorithms on neural language processing as well as subjective listening effort. Each participant hears 12 randomized segments of speech (about 4min long each) with different settings on their hearing aid (reference condition, noise reduction algorithm, beam forming algorithm). This will be a controlled, single blinded and randomized active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarter based in Stäfa.


Eligibility Criteria:
Inclusion Criteria:

* Healthy outer ear (without previous surgical procedures)
* Ability to fill in a questionnaire conscientiously
* Informed Consent as documented by signature

Exclusion Criteria:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend weekly appointments
* Limited ability to describe listening impressions/experiences and the use of the hearing aid
* Inability to produce a reliable hearing test result
* Massively limited dexterity
* Known psychological problems
* Known central hearing disorders
Active Breaks on Mental Health and Classroom Climate in Chilean Schoolchildren Aged 6 to 10

Background: The incidence of mental health issues in children is increasing worldwide. In Chile, a recent surge in reports of deteriorating mental health among school populations and an increase in complaints related to poor school climate have been observed. Physical activity, specifically active breaks in the classroom, has shown positive effects on children's health. However, evidence regarding its impact on mental health and school climate in children is limited.

Objective: This article outlines the design, measurements, intervention program, and potential efficacy of the Active Classes + School Climate and Mental Health project. This project will assess a 12-week program of active breaks through guided videos with curricular content in the school classroom, and its effects on mental health and school climate as its primary contributions. Additionally, it will measure physical activity, physical fitness, motor competence, and academic performance in students aged 6 to 10 years in the Biobío province, Chile, as secondary contributions.

Methodology: It will be performed a multicenter randomized controlled trial involving students in the 1st to 4th grade (6 to 10 years old), encompassing a total of 48 classes across six schools (three intervention and three control) in the Biobío region, Chile. Video-guided active breaks will be implemented through the Active Classes; web platform, featuring curricular content, lasting 5 to 10 minutes and of moderate to vigorous intensity physical activity, twice a day, Monday to Friday, over a span of 12 weeks.

Expected Results/Discussion: To our knowledge, this will be the first study in Chile to evaluate the effects of incorporating video-guided active breaks with curricular content on mental health variables and school climate in schoolchildren. Thus, this study contributes to the scarce evidence on the effects of video-guided active breaks on mental health variables and school climate in schoolchildren worldwide. Additionally, it will provide crucial information about active teaching methodologies that have the potential to positively contribute to the well-being of students, thus addressing the problems of mental health and climate in Chilean schools.


Eligibility Criteria:
Inclusion Criteria:

- a) Regular male or female students in primary education, from first to fourth grade, at a public school in one of the three provinces of the Biobío region, willing to participate and with parental consent.

b) Students spend at least 38 hours per week in classes (6.5 hours daily) and have at least two short breaks (10-15 minutes) per day.

Exclusion Criteria:

* a) Students with a medical diagnosis of spinal pathologies, vertigo, or uncontrolled hypertension.

  b) Students with severe intellectual disabilities prevented them from following the program instructions.

  c) Students participating simultaneously in another project with similar objectives.
Evaluation of an Innovative Medical Device Supporting Orthopedic Surgical Interventions

This study is a randomized, controlled, 2-arm, open trial to evaluate an innovative positioning system in the clinical setting of orthopedic surgery.

Aim of the study is the validation and comparison of the innovative medical device with the current standard method.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diastal fracture of the radius
* Patients with the mentioned fracture and indication for surgical treatment according to national guidelines
* Age \>/= 18 years of age
* Patients willing to participate and after having given their informed consent in written form

Exclusion Criteria:

* Participation in other interventional clinical trials
* Pregnant or lactating women