cyrilzakka/clinical-trials huggingface dataset:
The Link Between Diets and Health Indicators

The cohort study investigates the effect of different dietary intake among omnivorous, vegan, vegetarian and low-carb diets on health parameters and on long-term overall health. The participants blood parameters, dietary intake, gut microbiota composition, body mass and composition, resting energy expenditure, lifestyle factors and psychological factors will be determined and measured.

Vegetarian and vegan diets have been shown to have health benefits on preventing cardiovascular diseases, type 2 diabetes and cancer. They are both gaining popularity in public. Ketogenic diet has also been very popular, especially due to its effect on weight loss and blood glucose parameters. To our knowledge there, are no studies that compare long-term effects of all three diets and omnivorous diets with regards to health parameters and gut microbiota composition.

The aim of the proposed study is to investigate the link between different diets and health parameters, such as parameters related to longevity, inflammation, stress and gut microbiota composition. The study is designed to compare different diets and their relationship with the body as a whole.

Eligibility Criteria:
Inclusion Criteria:

* 18,5 \< BMI \< 30 kg/m2
* asymptomatic for any disease
* medication free
* same pattern of eating in the last 3 months
* stable body mass in the last 3 months

Exclusion Criteria:

* BMI \< 18,5 and \> 30 kg/m2
* presence of any chronic disease
* taking any medications
* changed eating pattern in the last 3 months
* unstable body mass in the last 3 months
* taking antibiotics in the last 3 months
Evaluation of a Smartphone Based Screening Tool for Neonatal Jaundice in Surabaya, Indonesia

A cross-sectional conductive study aiming to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns in Surabaya.

A cross-sectional conductive study aiming to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns at Airlangga University hospital and RSIA Kendangsari MERR in Surabaya.

This cross-sectional study evaluates the accuracy of a novel smartphone application that estimates bilirubin levels in Indonesian newborns. The Picterus Calibration Card was placed on the chest of the newborn with the hole in the card placed over the infant's sternum. A validated smartphone with Picterus JP was used to collect digital images.

Eligibility Criteria:
Inclusion Criteria:

* Infants born with gestational age \>31
* Birth weight ≥ 1500g
* Age 0 - ≤14 days
* Consent obtained from the parents

Exclusion Criteria:

* Infants born with congenital abnormalities;
* Infants respiratory support;
* Infants suffering from a condition that may alter the skin tissue circulatory system, such as sepsis and heart failure;
* Infants who have received phototherapy in the last 24 hours.
Prospective Non-Interventional Observational Study of Use of TRIUMEQ and Corresponding Monitoring Measures in Clinical Practice in Germany

TRIUMPH is a prospective, non-interventional observational study on the use of the fixdose combination TRIUMEQ (Dolutegravir/Abacavir/Lamivudine) and the respective monitoring measures in the practice of HIV care in Germany. The primary study objective is a descriptive report of the incidence of therapeutic monitoring measures in HIV-infected patients under TRIUMEQ therapy in everyday routine practice in Germany. The study is designed to enroll approximately 400 patients. There are no protocol-mandated visits or procedures associated with the study. Each patient is expected to participate for a maximum of 3 years or until premature discontinuation (i.e., discontinuation of TRIUMEQ, due to death, withdrawal of consent, lost to follow-up. TRIUMEQ is a registered trademark of the ViiV Healthcare group of companies.


Eligibility Criteria:
Inclusion Criteria:

* Documented HIV infection
* Age ≥ 18 years
* HLA-B\*5701-negative
* Decision for first initiation of TRIUMEQ therapy made by the attending physician independent of the inclusion in this observational study

Exclusion Criteria:

* Prior dolutegravir therapy (cf. also Capping ABC in section 3.3 Recruitment)
* Participation in a clinical trial during this study
Biological Consequences of an Ultra Endurance Race

The aim is to study per and post-exertion variations of biological markers during an ultra-endurance race

25 healthy adult volunteers participating in the "100 miles South of France 2017©" race recruited electronically by an announcement on the race website

Eligibility Criteria:
Inclusion Criteria:

1. Age greater 18 years.
2. Subject having already completed an ultra-endurance race (distance greater than 50 kilometers) during the 24 months preceding the race.
3. Affiliation of a social security.

Exclusion Criteria:

1. Age lower than 18 years
2. Subjects with a medical history (pulmonary pathology, cardiac, hypertension) or having a significant chronic inflammatory disease known at the time of the inclusion visit the day before the race.
3. Female
Vascular Reactivity Assessment by the AngioDefender Device -- A Precision Study

The objective of this study is to define the repeatability and reproducibility of quantifying flow-mediated dilation (FMD) of the brachial artery (BA) using the AngioDefender (AD) methodology.

Repeatability will be assessed by repeat AD testing of the same subject 1 hour apart, using the same AD device and operator.

Reproducibility will be assessed by comparing FMD scores obtained for the same subject, but using different AD devices and operators.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women, ≥18 years old
2. Eastern Cooperative Oncology Group/Zubrod score performance status of 0, 1, or 2, determined within 7 days prior to FMD testing on Study Day 1 (Visit 1)
3. Written informed consent understood and signed; understanding of study procedures and ability to comply with them for the length of the study

Exclusion Criteria:

1. Body mass index (BMI) \>50 kg/m2
2. Mid-upper arm circumference of arm selected for FMD testing \<17 cm or \>42 cm
3. Sinus arrhythmia, atrial fibrillation, atrial flutter, multifocal atrial tachycardia, frequent (\>1 per 10-sec strip) premature atrial or ventricular contractions (isolated, non-isolated, or alternating), documented by 12-lead ECG with rhythm strip at the time of subject screening.
4. Clinical signs and/or symptoms of active viral or bacterial infections
5. Resting muscle tremor or inability to remain still for the duration of the testing period
6. Systolic blood pressure (SBP) at rest of \>170 mmHg or diastolic blood pressure (DBP) at rest of ≥110 mmHg.
7. Diabetic subjects - Type I or II
8. Previous intolerable adverse reaction(s) to vascular testing using an upper extremity occlusive pneumatic cuff
Magnetic Resonance Imaging and Ultrasonography in Evaluation of Muscle Diseases

This study aims to determine the association between the pathological changes detected by ultrasound and those detected in MRI in muscle diseases of different etiologies.

Enrolled patients will be subjected to the following:

Neuro-imaging Studies:

1. Skeletal Muscle ultrasound:

   The muscle group(s) to be assessed will be determined based on the category of the muscle disease for which the patient is being evaluated. A linear probe of 5-12 megahertz will be used.
2. MRI of the suspected (affected) muscle group by ultrasound. Image acquisition: Selective regional MRI imaging will be done based on the results of muscle ultrasound MRI cuts included are the axial section of conventional T1- and T2-weighted sequences, for the evaluation of muscles' signal intensity and bulk.

Patients will be subjected to both imaging studies to compare their accuracy.

Neurophysiological Studies:

1. Nerve conduction study
2. Electromyogram The interpretation of the neurophysiological studies will be performed by a neuropsychiatry specialist, Department of Neurology, Assiut University Hospital.

Eligibility Criteria:
Inclusion Criteria:

1. A clinical diagnosis of muscle diseases; irrespective of different etiologies
2. Age \> 3 years

Exclusion Criteria:

1. Patients with altered muscle anatomy due to severe trauma, tumor or surgery.
2. Severe deformity preventing examination.
3. Age \< 3years.
4. Patients with contraindications to MRI as patients with pacemaker, aneurysmal clipping, retained metallic
Dental Implant Care and Oral Hygiene Practices

Objective: This study investigated how patients' knowledge, attitude, and perceptions influence their oral hygiene practices as well as peri-implant health. Materials and Methods: Participants with single implant crowns placed in 2007-2011 completed a questionnaire that examined their knowledge, attitude, and perceptions on oral hygiene practices and peri-implant health before receiving a periodontal examination, prophylaxis, and oral hygiene education. Clinical parameters recorded were peri-implant probing depths and plaque index, width of keratinized mucosa, implant crown characteristics, reason for tooth loss, and diagnosis of peri-implant health.

First, a trained clinical research dental assistant interviewed the participants and showed them pictures of oral hygiene aids so that the participants could answer the survey questions accurately. Subsequently, a periodontal examination, dental prophylaxis, and oral hygiene education were performed. Participants with active diseases e.g. caries, periodontitis, or peri-implantitis were referred for further management. The following clinical parameters were recorded during the examination:

1. Probing depths at 6 sites around the implant (mesiobuccal, midbuccal, distobuccal, distolingual, midlingual and mesiolingual)
2. Plaque index (Silness \& Loe 1964) at 4 sites around the implant (mesial, buccal, distal and lingual)
3. Amount of keratinized mucosa at the implant site
4. Characteristics of the implant crown:

   * Type of implant crown (screw- or cement-retained) and
   * Position of crown margins (supra-, equi- or sub-gingival)
5. Reason(s) for tooth loss
6. Diagnosis of peri-implant health

   * Normal
   * Mucositis, defined as 3 or more bleeding points per implant
   * Peri-implantitis, defined as implant thread exposure that was either clinically visible or detectable with a periodontal probe.

Eligibility Criteria:
Inclusion Criteria:

* English speaking patient
* Aged 21 years old or above
* Received at least 1 implant-supported single crown from NUH in the year 2007-2011 (in functional loading for at least 5 years)

Exclusion Criteria:

* Implant is used to restore overdentures or multi-unit restorations such as splinted crowns, fixed partial dentures, and cantilevers.
* Pregnant/lactating women
* Parkinson's disease or any other debilitating diseases
* Physical or mental disabilities that may impair oral hygiene practices
* Poorly controlled diabetes
* Heavy smoker (10 or more cigarettes per day)
* Radiation therapy in head and neck region
* HIV, TB, hepatitis or other infectious diseases
* Drug and alcohol abuse
the Effect of Implanon on Menstrual Patterns

This study aims to evaluate whether the timing of postpartum Implanon insertion (immediately postpartum, early postpartum, or late postpartum) affects menstrual patterns

* Etonogestrel implants (Implanon) are widely used for postpartum contraception. However, the timing of insertion may influence menstrual patterns, including irregular bleeding, amenorrhea, and prolonged bleeding episodes. Despite the increasing use of immediate postpartum contraception, there is limited research on how the timing of Implanon insertion affects menstrual cycle regulation.
* Furthermore, lactation and hormonal changes postpartum may modify the bleeding patterns in women using Implanon, with breastfeeding women experiencing a higher likelihood of amenorrhea due to prolactin-induced suppression of ovulation.
* This study aims to fill these gaps by systematically comparing menstrual outcomes based on timing of Implanon insertion postpartum

Eligibility Criteria:
Inclusion Criteria:

* Postpartum women opting for Implanon as contraception.
* No contraindications to hormonal contraception.

Exclusion Criteria:

* . Women with known bleeding disorders.
* Use of other hormonal contraceptives during the study period.
* Postpartum complications such as severe infections or retained products of conception
The Effect of Light Deprivation on Visual Functions in Adult Amblyopes

Amblyopia is a significant health problem, affecting up to 4% of the population in the United States. Amblyopia, commonly known as "lazy eye," is a developmental visual disorder in which one or both eyes suffer from poor vision as a result of being disadvantaged in early life. Strabismus, or eye misalignment, such as crossed eyes (esotropia) or wandering eyes (exotropia), and anisometropia, or a power difference between the eyes, are the most common causes of amblyopia. If conventional treatment, such as patching the better seeing eye, is not initiated during the critical period of visual development, lasting visual impairment may persist throughout life. This critical period of visual development has been thought to end around age 10. However, recent research has demonstrated that the critical period of visual development can be extended into adulthood. Complete light deprivation in animal models has restored plasticity in the visual cortex and has demonstrated drastic recovery of vision in amblyopic eyes. The objective of this pilot study is to evaluate the impact of complete light deprivation on visual function in a cohort of human adults with severe amblyopia from anisometropia.


Eligibility Criteria:
Inclusion Criteria:

* Amblyopia, defined as decreased vision, less than or equal to 20/100, in one eye secondary to anisometropia
* Age 18-50 years

Exclusion Criteria:

* Strabismus
* Eye pathology, such as cataract, corneal disorder, maculopathy, glaucoma,
* Mental health diagnosis, such as depression, schizophrenia, bipolar disorder or anxiety disorder
Development and Validation of a Deep Learning System for Multiple Ocular Fundus Diseases Using Retinal Images

Retinal images can reflect both fundus and systemic conditions (diabetes and cardiovascular disease) and firstly to be used for medical artificial intelligence (AI) algorithm training due to its advantages of clinical significance and easy to obtain. Here, the investigators developed a single network model that can mine the characteristics among multiple fundus diseases, which was trained by plenty of fundus images with one or several disease labels (if they have) in each of them. The model performance was compared with those of both native and international ophthalmologists. The model was further tested by datasets with different camera types and validated by three external datasets prospectively collected from the clinical sites where the model would be applied.


Eligibility Criteria:
Inclusion Criteria:

* The quality of fundus images should clinical acceptable. More than 80% of the fundus image area including four main regions (optic disk, macular, upper and lower retinal vessel archs) are easy to read and discriminate.

Exclusion Criteria:

* Images with light leakage (\>30% of area), spots from lens flares or stains, and overexposure were excluded from further analysis.
Investigation of the Effect of Stair Activity on Lumbal Paravertebral Mechanical Properties in Amputes.

With the onset of prosthesis use following lower extremity amputations,body shows biomechanical changes according to the amputation level and consequently develops adaptation mechanisms both on the healthy and ampute side. Adaptations in the lumbo-pelvic and lower lumbar regions cause asymmetries in the muscle tissue by causing changes in the morphological structure of the muscle, especially in the muscles of the waist, hip and knee and recruitment.

The aim of this study is to investigate the effect of stairing up and down activity on the mechanical properties of lumbal paravertebral muscles in TFA and TTA and its relation with lower lumbar region pain.


Eligibility Criteria:
Inclusion Criteria:

* to be TTA and TFA
* No complaints of chronic low back pain before amputation
* Using prosthesis for at least 6 months
* Being able to climb up and down stairs
* No history of falls that will cause injury or pain in the past 6 months
* Having good prosthesis comfort
* BMI\<28.5
* Who can have cognitive functions to understand Arabic language

Exclusion Criteria:

* To be amputated due to congenital and tumor
* Who can not have cognitive functions to understand Arabic language
* Having orthopedic or neurological disorders that may cause chronic pain or functional impairment in the lumbar region
* Ankylosing spondolitis and rheumatoid arthritis patients
Use of Probiotics to Reduce Infections, Death and ESBL Colonisation

This study examines the effect of oral probiotic treatment to newborns on preventing hospitalizations, death and colonization with Extended-spectrum beta-lactamase-producing Gram negative bacteria. Half of the babies will receive 4 weeks treatment with an oral mixture of the probiotic Labinic (R) while the other half will receive a placebo mixture.

Studies show that probiotics given to prematurely born babies prevents sepsis and is widely used in the western world for this purpose. Probiotics consists of one or more normal gut-bacteria. A large study in India showed that giving probiotics to full-born babies reduced hospitalizations and morbidity. This study investigates giving a probiotic mixture with different combination of bacteria, Lactobacillus acidophilus, Bifidobacterium infantis and Bifidobacterium breve, for a longer duration (4 weeks instead of 7 days).

Infections with antibiotic-resistant bacteria is a major threat to health-care world-wide, and sepsis/severe infection caused by such bacteria is a major cause of neonatal death. The study hypothesis is that giving probiotics to newborns prevents them from getting colonized with antibiotic-resistant bacteria, such as Extended-spectrum beta-lactamase-producing Enterobacteriaceae (ESBL-PE). By preventing colonization with ESBL-PE, severe infections such as sepsis may be prevented, and thereby survival may be improved.

Eligibility Criteria:
Inclusion Criteria:

* Healthy newborn infants with a birth weight equal or above 2.0 kgs, will be included in the study between 0-3 days of life.
* Newborn infants have to come from families who are long-term or permanent residents in the defined catchment area for this trial (30 km radius from HLH) in Tanzania.
* Parents are able and willing to complete study visit (including required study procedures) schedules over the six months proposed follow-up, which also includes hospitalizations required for compliance of this study protocol.
* Parents agrees for the child not to participate in another study during the study period
* Children less than one year admitted to hospital with suspected infection, not included in the RCT, will be included in a sub-study. A separate inclusion form is prepared for these children.

Exclusion Criteria:

* Birth weight below 2 kg
* Other health problems/illness, obvious congenital malformations.
* Multiple pregnancy
* Parents not consenting
Blood Pressure Lowering of Aliskiren HCTZ Compared to HCTZ in Stage 2 Systolic Hypertension in Older Population

The purpose of the study is to evaluate the efficacy and safety of initial use of a fixed dose combination of aliskiren Hydrochlorothiazide (HCTZ) compared to Hydrochlorothiazide in older population with Stage 2 systolic hypertension.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female outpatients, ≥ 55 years old
2. Patients with essential hypertension
3. Prior to randomization: Patients must have an office cuff mean sitting Systolic Blood Pressure ≥ 160 mm Hg and \< 200 mm Hg
4. Patients who are eligible and able to participate in the study, and who are willing to give informed consent before any assessment is performed

Exclusion Criteria:

1. Office blood pressure measured by cuff (msSBP ≥ 200 mm Hg and/or msDBP ≥ 110 mm Hg) at Visits 1-5
2. History or evidence of a secondary hypertension of any etiology (e.g., uncorrected renal artery stenosis, pheochromocytoma).
3. History of hypertensive encephalopathy or heart failure (New York Heart Association \[NYHA\] Class II-IV)
4. Cerebrovascular accident, transient ischemic cerebral attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI) within 1 year prior to Visit 1
5. Serum sodium less than the lower limit of normal, serum potassium \< 3.5 mEq/L (corresponding to 3.5 mmol/L) or ≥ 5.3 mEq/L (corresponding to 5.3 mmol/L), or dehydration at Visit 1.
6. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\> 5 mIU/mL)
7. Use of other investigational drugs within 30 days of enrollment.

Other exclusions may apply.
Occupational Therapist-Led Work Intervention in Facilitating Work Maintenance or Re-entry to the Workforce in Patients With Stage I to III Breast Cancer Undergoing Chemotherapy

This trial studies how well occupational therapy (occupational therapist-led work intervention) works in facilitating work maintenance or re-entry to the workforce for stages I to III breast cancer patients who will be undergoing curative intent chemotherapy. Occupational therapy may help cancer patients maintain employment or successfully return to work soon after treatment.

Patients receive in-person occupational therapist-led work consultation.

Eligibility Criteria:
Inclusion Criteria:

* Stage I-III breast cancer patients who will be undergoing curative intent chemotherapy
* Working in a paid capacity (part or full-time) at time of diagnosis with the intent to maintain or return to work following treatment

Exclusion Criteria:

* Non-English speaking patients. This study requires completing online questionnaires that are written in English and will not be translated
* Patients with a psychiatric or neurological condition that impairs capacity to make decisions
Pediatric Fiberglass Crown in Primary Teeth

This randomized controlled clinical trial aims to evaluate the clinical success of fiberglass crowns applied to primary teeth and to assess the impact of two different luting cements on the success of the fiberglass crowns. The main questions to answer are:

* Will fiberglass crowns demonstrate sufficient clinical success to serve as a viable alternative to existing pediatric crowns?
* Will there be any differences in the clinical success and mechanical properties of fiberglass crowns based on the type of luting cement used?

Thirty-eight children (60 teeth), between 5 and 9 years old (7.03±1.14), enrolled for the study. The researchers evaluated the clinical success of fiberglass crowns bonded with two different types of luting cement (1: FujiOne; 2: FujiCEM 2) based on retention, anatomical integrity, effect on periodontal health and parental satisfaction.

Participants will:

-Visit the clinic 1st, 3rd, 6th, 12th months after cementatiton.


Eligibility Criteria:
Inclusion Criteria:

For participants:

* absence of any systemic disease
* absence of any periodontal disease
* no unilateral chewing habit
* a Frankl scale score of three-four

For teeth:

* no percussion or palpation sensitivity
* no malocclusion
* no pathological mobility
* no pulpal treatment due to caries or other reasons
* had sound cervical margins
* not hypoplastic or hypocalcified
* had opposing functioning teeth
* had physiological root resorption not exceeding one-third of the root length
* had deep dentin caries with two or more surface that do not contain pulp involvement

Exclusion Criteria:

* did not attend their follow-up appointments