cyrilzakka/clinical-trials huggingface dataset:
A Study of Biological Effects of a Polyphenol Supplement

A randomized, double-blind, placebo controlled, cross-over trial to investigate the effect of the Investigational Product "DailyColors™" (DC) on age-related pathways in adults.

The aim of this study is to measure the effects of acute treatment with DC on key pathways relevant to healthy ageing using blood biomarkers.

Based on power calculations a sample size of 20, is sufficient to detect an effect size of 0.46 at a power \> 90%. To account for dropout the investigators will include 26 subjects in total.

Aims:

The aim of this study is to measure the effects of acute treatment with DC on key pathways relevant to healthy ageing using blood biomarkers.

Hypotheses:

There will be preliminary evidence that the IP has positive clinical effects on biologically relevant pathways related to healthy aging of brain and muscle including blood markers of inflammation, oxidative stress markers, and trophic factors.

Design:

A randomized, double-blind, placebo controlled, cross-over trial to investigate the effect of the Investigational Product (DailyColors™) on age-related pathways in adults. Participants will receive DailyColors™ or placebo for a week, then one week wash-out, and then placebo/Dailycolors™ for a week, in random order. In addition, participants will be invited to participate in an open-label extension study for 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, (NB Equal number of male and female participants)
* Age between 55 and 80
* Body Mass Index (BMI) over 25 (since this group is expected to have a some degree of inflammation and other metabolic changes and more likely to respond to the supplement)
* Willingness to complete questionnaires, records and diaries associated with the study and to complete all clinic visits
* Provided voluntary, written, informed consent to participate in the study.

Exclusion Criteria:

* Alcohol or drug abuse in past year
* Subject has a known allergy to the test material's active or inactive ingredients
* Subjects with unstable, life-threatening medical conditions
* Use of polyphenol or phytochemical supplements
* Use of dietary supplements last month, except from cod liver oil or other vitamin D supplements
* Vegetarians and Vegans
* Clinically significant abnormal laboratory results at screening
* Participation in a clinical research trial within 30 days prior to randomization
* Individuals with dementia and/or who are unable to give informed consent
* Individuals with unusual high intake of fruit, berries, vegetable and/ or coffee intake, \> 5 portions of fruit, berries and/or vegetables per day or \> 5 cups of coffee per day
* Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject.
Fish Consumption and Dietary Diversity in Timor-Leste

A one-year, cluster-randomized, partially masked, controlled trial to test and compare the effects of fish aggregating devices and social and behaviour change communication on the frequency and volume of household fish consumption in upland areas of Timor-Leste.

This trial is a one-year, cluster-randomized, partially masked, controlled trial among families living in rural, inland Timor-Leste. This trial aims to test and compare the effects of two treatments, alone and in combination, on the frequency and volume of household fish consumption in upland areas as a proxy for improved dietary diversity and micronutrient intake. Treatment 1 is the installation of nearshore, moored fish aggregating devices (FADs) to improve catch rates with existing fishing gears. Treatment 2 is social and behaviour change (SBC) activities to promote fish consumption. Villages in inland communities will be randomized to receive treatment 1, treatment 2, both treatments, or neither treatment. Some households with one child under five will be recruited, and data will be collected at baseline (prior to the rollout of the treatments) and endline. Our study will determine the impact of an improved supply of fish, along with nutrition-oriented SBC activities, on the fish purchasing and consumption practices of rural, inland households. Findings from this study are urgently needed by small island developing states in order to make policy and investment decisions on how best to improve households' diets using locally available, nutrient-dense foods such as fish. Investments such as these are needed to break the cycle of malnutrition.

Eligibility Criteria:
Inclusion Criteria:

* The individual's household is situated in a village included in the study, within a 30km radius of a coastal treatment site.

Exclusion Criteria:

* The individual's household is not situated in a village included in the study.
Study of NK Combined With Chemotherapy for Advanced Solid Tumor

Combinations Natural Killer Cell (NK) With chemotherapy treatment may enhance the immune response and stop cancer cells from growing.

Patients in group A will receive 4 cycles of NK treatments within 8 months. Patients in group B will have no immunotherapy. Chemotherapy are available in both groups.The investigators want to evaluate the efficacy of combination of NK with chemotherapy in patients with treatment-refractory solid tumors

Eligibility Criteria:
Inclusion Criteria:

1. Patients with treatment-refractory advanced solid cancer can not accept operation;
2. Age 10 to 90 years;
3. Eastern Cooperative Oncology Group (ECOG) score ≤ 2 points;
4. estimate survival \> 3 months;
5. Blood White Blood Cell(WBC)≥ 4×109/L, Hb ≥ 100g/L, Platelet Count (PLT)≥ 80×109/L; Alanine amino transferase (ALT) and aspartate amino transferase (AST)≤ 2 times of normal upper value; Serum Cr ≤ 2 normal upper value;
6. Without any other malignant disease;
7. With more than one scalable lesions;
8. Patients Voluntary attempt, and informed consent;
9. Women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the preparative chemotherapy on the fetus.

Exclusion Criteria:

1. Patients who do not conform to the inclusion criteria;
2. Patients with uncontrolled infection; underlying disease that was severe or life-threatening (such as uncontrolled brain metastasis );
3. Patients who were pregnant or lactating;
4. ECOG perform status ≥ 2;4.
5. Other situations that the researchers considered unsuitable for this study (such as mental illness, drug abuse, etc.)
External Micropulse Diode Laser Transscleral Trabeculoplasty (EMDLT) for Severe Open Angle Glaucoma

To prove that external contact micropulse diode laser trabeculoplasty (EMDLT) can significantly lower intraocular pressure in cases of advanced open angle glaucoma.

Micropulse diode laser trabeculoplasty applied through a gonioscopy len has been shown to be effective in lower the pressure for patients with primary open angle glaucoma (POAG). We believe that applied externally, the contact diode micropulse laser will be effective in lowering intraocular pressure for patients with advance open angle glaucoma with minimal side effects

Eligibility Criteria:
Inclusion Criteria:

* • Diagnosis of Primary Open Angle Glaucoma

  * Advanced glaucoma with intraocular pressure higher than 21mmHg on one or more topical medications (for at least 2 months)
  * Visual acuity worse than 6/6
  * Age more than 21 years
  * Poor candidate for additional filtration surgery

Exclusion Criteria:

* • Age less than 21 years

  * Any eye surgery within 2 months of enrolment
  * Any patient with rubeosis
  * Unable to give informed consent
Acute Effects of Supramaximal High-Intensity Interval Training in People With COPD

High-intensity exercise is essential for optimal development of cardiorespiratory fitness and health. This is, however, challenging for most people with chronic obstructive pulmonary disease (COPD) due to ventilatory limitations, leading to exercise at lower intensities accompanied by suboptimal stress on the cardiovascular and muscular system.

The aims of this cross-over trial is:

1. To compare the acute effects of short-duration supramaximal high-intensity interval training (HIIT) vs. traditional moderate-intensity continuous training (MICT) in people with COPD and matched healthy controls (HC).
2. To investigate the feasibility of supramaximal HIIT in people with COPD and matched HC.
3. To compare the cardiorespiratory demand, exercise intensity and symptoms during a modified Borg Cycle Strength Test (BCST) and a cardiopulmonary exercise test (CPET) in people with COPD and HC.

In this study, eligible participants attended the facility four times within 14 days with at least 48 hours of rest between visits.

Exercise tests (visit 1, week 1):

After pulmonary functions tests, a CPET on a stationary bicycle was performed according to international guidelines. After 1.5 hours of recovery, a BCST was performed to assess anaerobic exercise capacity and determine exercise intensities for supramaximal HIIT.

Exercise sessions (visit 2 - week 1; visit 3 - week 2; visit 4 - week 2):

The order of the two first exercise sessions (HIIT at 60% of MPO6 or MICT) on a stationary bicycle were randomized. The exercise session at HIIT at 80% of MPO6 was always the third exercise session.

During all exercise sessions, blood collection was performed at baseline after a 15-minute seated rest. During HIIT, blood was collected immediately after, and 30 minutes after the 10-minute HIIT period. For MICT, blood was collected after 10 minutes (isotime in relation to HIIT), immediately after, and 30 minutes of cycling at 60% MAP.

Eligibility Criteria:
COPD

Inclusion Criteria:

* COPD with non-reversible airflow obstruction diagnosis (post-bronchodilator forced expiratory volume during the first second/forced vital capacity (FEV1/FVC) \< 0.7)
* Age: \> 40 years

Exclusion Criteria:

* Recent exacerbation of COPD (\< 6 weeks)
* Neuromuscular, orthopaedic and/or any other condition that can compromise participation in testing
* Recent lung cancer (\< 5 years)
* Unstable cardiac disease and/or cardiac stimulator

HC

Inclusion Criteria:

- Age: \> 40 years

Exclusion Criteria:

* Neuromuscular, orthopaedic and/or any other condition that can compromise participation in testing
* Any respiratory disease
* Recent lung cancer (\< 5 years)
* Unstable cardiac disease and/or cardiac stimulator
* Too low or high physical activity level that prohibits matching
Effect of Pre-emptive Dose of Prednisone Versus Placebo in Impacted Third Molar Surgery

The present study proposes to compare the effect of a single preoperative dose of prednisone versus placebo in terms of facial swelling, trismus and pain after surgical removal of the mandibular third molar (M3M) in a split-mouth randomized controlled clinical trial.

This study aims to compare the effect of a single preoperative dose of prednisone versus placebo in terms of facial swelling, trismus, and pain after surgical removal of M3M in a split-mouth randomized controlled clinical trial. Facial swelling will be evaluated using an innovative three-dimensional digital technique.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 32 years who required both M3M extractions were recruited
* Good health status
* Indication to surgical extraction of both M3M
* Complete root formation
* Surgical risk level classified as "Conventional" or "Moderate" according to Daugela et al. classification

Exclusion Criteria:

* Person under the age of 18 or over 32
* Allergy or contraindications to administration of corticosteroids
* Acute infection in any of the teeth to be extracted
* Patients with chronic liver disease, diabetes, immune system dysfunction, or haematological disease
* Pregnancy or breastfeeding
* History of treatment with antiresorptive drugs
* Chronic kidney disease
* History of systemic corticosteroid therapy in the past 4 weeks
Function and Imaging Assessments for G1961E-associated Stargardt Disease

Some phenotypes of Stargardt disease are rather distinct. This includes the 'bull's eye maculopathy' phenotype associated with the frequent ABCA4 G1961E variant. In anticipation of a treatment trial, this natural history study aims to compare functional and structural outcome measures systematically.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with G1961E-associated Stargardt disease
* Defined by (1.) the presence of two pathogenic ABCA4 variants with at least one ABCA4G1961E variant, (2.) a Stargardt disease phenotype, and (3.) the absence of pathogenic variants in PRPH2, PROM1, and ELOVL4

Exclusion Criteria:

* Inability to give informed consent
* Prior surgery (other than anti-VEGF injections, cataract surgery, YAG laser capsulotomy, or laser retinopexy) that - according to the investigator's judgment - may affect visual function assessments (e.g., retinal detachment surgery, glaucoma filtration surgery, or a history of a corneal transplant in the study-eye)
* Concurrent ophthalmic conditions in the study eye that (according to the investigator's judgment) may contribute to loss of vision such as clinically significant opacification of the ocular media (corneal dystrophies, cataract), other retinal diseases, or disease of the optic nerve head and visual pathway (including amblyopia)
* Major surgery planned or other events that (according to the investigator's judgment) could hinder follow-up examinations (e.g., knee replacement)
Mhealth Supported Bundle to Improve Vaccination Completion

Supported be a digital vaccine registry the investigators will test the impact of automated appointment reminders, real time appointment reminders, motivational interviewing and targeted vaccine on routine childhood vaccine completion rates.

Bundling three high-impact mHealth interventions (a digital vaccine registry (supply side), a reminder system (demand side), and targeted vaccine drive (demand and supply-side) will be feasible, acceptable, carried out with fidelity, and result in a 10% improvement in vaccine completion rates compared to the year prior to implementation.

Eligibility Criteria:
Inclusion Criteria:

* All parents or caregivers of patients who bring their child to the vaccine clinic to receive immunization for their first vaccine visit.

Exclusion Criteria:

* Parents or caregivers not willing to participate.
A Randomized Controlled Trial Evaluating the Role of Negative Pressure Wound Therapy (NPWT) for Incisional Surgical Site Infections in Patients Undergoing Hepatopancreatobiliary Surgery

To compare the rates of incisional surgical site infections (iSSIs) within 7 days of hepatopancreatobiliary (HPB) surgery using negative pressure wound therapy (NWPT) versus using standard sterile gauze dressing.


Eligibility Criteria:
Inclusion Criteria:

All patients undergoing elective open HPB surgery (benign or malignant disease) of age \> 18 years consenting to the study protocol.

Exclusion Criteria:

The patient in which primary wound closure is not achieved. The patient planned for a second look surgery. The patient with the history of long-term antibiotic use (more than a month). Past history of open abdominal surgery (less than 1 month).
Sing for Your Saunter - Dementia Supplement

Older adults, and particularly those with Parkinson disease (PD), may experience walking difficulties that negatively impact their daily function and quality of life. People that have PD plus dementia are also likely to experience walking difficulties. This project will examine the impact of music and mentally singing on walking performance, with a goal of understanding what types of rhythmic cues are most helpful. Pilot work from the investigators suggests that imagined, mental singing (i.e., singing in head) while while walking helps people walk faster with greater stability, whereas walking to music also helps people walk faster but with reduced stability.

In this study, the investigators will recruit people who have PD plus dementia. The investigators will compare walking while mentally singing and walking while listening to music, using personalized cues tailored to each person's walking performance. The investigators hypothesize temporal variability of gait will be lower in the mental singing and singing conditions compared to listening to music; and that mental singing, singing, and listening to music will elicit similar improvements in stride length.

During this observational study, participants will attend one visit in the laboratory. The visit will include participants wearing wearable sensors during the following tasks: walking with no cues (UNCUED), walking while listening to music (MUSIC), and walking while mentally singing (MENTAL SINGING). The wearable sensors will measure gait parameters including gait speed, stride length, and stride time variability.

Eligibility Criteria:
Inclusion Criteria:

* at least 30 years of age
* diagnosis of idiopathic, typical Parkinson disease according to the UK Brain Bank Criteria
* Hoehn \& Yahr stages 2-3 (mild to moderate disease severity)
* normal or corrected hearing
* stable on all PD medications for at least 2 months prior to study entry
* dementia as defined by a Clinical Dementia Rating (CDR) score of 0.5-1.0 (very mild to mild dementia)
* score of ≥ 1 on the MDS-UPDRS-III Item #10 indicating observable gait impairment
* a score of 1 or less on item #7 on the freezing of gait questionnaire
* able to walk for 10 continuous minutes independently

Exclusion Criteria:

* diagnosis of any other neurological condition
* unstable medical or concomitant illnesses or psychiatric conditions which, in the opinion of the investigators, would preclude successful participation
* cardiac problems that interfere with ability to safely participate (i.e., uncontrolled congestive heart failure, myocardial infarction in past 6 months, complex cardiac arrhythmias, significant left ventricular dysfunction, dyspnea on exertion, chest pain or pressure, resting tachycardia (\>100 beats/min); uncontrolled BP (resting systolic BP \>160 mmHg or diastolic BP \>100 mmHg))
* orthopedic problems in the lower extremities or spine that may limit walking (i.e., severe arthritis, spinal stenosis)
* uncontrolled tremor or dyskinesia while on PD medications
Evaluation of Postural Control in Premature Children

To date, it is largely unknown whether preterm children experience balance problems and whether they have normal postural control. Assuming that postural adaptation is affected after preterm delivery because it depends on attention and fine motor control, the postural control and motor development of children born preterm less than 32 weeks in the 5-7 age period will be affected compared to their healthy controls. Identifying these situations according to their healthy peers will improve the general health of premature births and enable better intervention methods to be designed.

Thanks to modern technical interventions and trained health personnel, the survival rate of premature babies has increased significantly in recent years. Neurodevelopmental abnormalities increase as birth weight and gestational week decrease and the presence of adverse biological conditions add up. Brain structures involved in fine motor control, such as the cerebellum, basal ganglia, corpus callosum, amygdala, and hippocampus, are smaller in babies born preterm, even without premature brain damage. Many of the problems associated with these in children are often difficult to detect at an early age, so numerous symptoms may not be detected until school age. In this sense, making periodic assessments of the progress in each child's motor development is essential to identifying deficiencies and thus facilitates referral to early intervention programs.

Eligibility Criteria:
Inclusion Criteria:

* Premature children born less than 32 weeks
* Age between 5-7 years
* Neurological development to be normal
* Giving an informed consent

Exclusion Criteria:

* Not giving an informed consent
Cesarean Scar Defect (CSD); Prevalence, Risk Factors And Possible Associated Symptoms

The study aims to detect the incidence of Cesarean Scar Defect (CSD) in women undergoing CS in Women Health Hospital (WHH), assiut University, to identify risk factors for development of CSD and identify the possible gynaecological symptoms related to CSD.

All eligible women, who will undergo CS in Women Health Hospital (WHH) will be seen on regular visits to detect the presence of CSD by ultrasound and identify its characters and a questionnaire will be fulfilled by the candidates about the gynecological symptoms related to CSD and appeared after CS.

Eligibility Criteria:
Inclusion Criteria:

* All women who will undergo transverse lower segment cesarean section after 28 weeks gestational age (electively and Emergency), after counseling and written consent

Exclusion Criteria:

1. Rupture uterus (unscarred or scarred).
2. Upper segment CS.
3. Vertical lower segment CS.
Construction and Application of Database of Hebei Provincial Gastric Cancer Collaborative Network Driven by Artificial Intelligence Technology

This clinical trial aims to construct and apply a collaborative network database for gastric cancer in Hebei Province, driven by artificial intelligence (AI) technology. The project seeks to integrate clinical data, genomic information, and treatment outcomes from multiple hospitals and research centers within the region. By leveraging advanced AI algorithms, the database will facilitate comprehensive data analysis to identify novel biomarkers, optimize therapeutic strategies, and improve patient outcomes. This initiative will also support real-time data sharing and collaboration among healthcare providers, researchers, and policymakers, ultimately enhancing the overall management and treatment of gastric cancer in Hebei Province.


Eligibility Criteria:
Inclusion Criteria:

All patients with gastric cancer

Exclusion Criteria:

None
Fludara (Oral) Phase II Study for Indolent Lymphoma

To assess the antitumor effect and safety of Fludara in patients with indolent lymphoma.

As of 29 May 2009, the clinical trial sponsor is Genzyme Corporation. NOTE: This study was originally posted by sponsor Schering AG, Germany, which was subsequently renamed to Bayer Schering Pharma AG, Germany.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically or cytologically confirmed indolent lymphoma (including mantle cell lymphoma)
* Patients with measurable lesions (major axis \> 1.5 cm by CT)
* Patients who failed to have PR to previous chemotherapies or antibody therapies. Patients with subsequent relapse after a previously attained CR or with subsequent recurrence after a previously attained PR
* Patients who have not received chemotherapies, antibody therapies or radiotherapies for more than 4 weeks (more than 3 months in the case of the antibody therapies)
* Patients who have PS Grade 0 to 2 in the criteria of ECOG
* Patients with adequately maintained organ functions

Exclusion Criteria:

* Patients with infectious disease, serious complications, serious gastrointestinal symptoms, serious bleeding tendency (DIC), CNS metastases, fever more than 38 degrees Celsius, interstitial pneumonia or pulmonary fibrosis, active other malignancies, AIHA or the history of allergies to similar purine analogs
* Patients who are positive for HBs antigen, HCV antibody or HIV antibody
* Patients who received G-CSF or blood transfusion within 1 week before the screening test
* Patients who had ever received previous therapy with fludarabine phosphate injection (Fludara), pentostatin (Coforin), cladribine (Leustatin) or SH T 586
* Patients who are pregnant, of childbearing potential, lactating, or who do not agree to practice contraception