cyrilzakka/clinical-trials huggingface dataset:
Immunogenicity and Safety of DTP-HB-Hib Using New Hepatitis B Bulk (Bio Farma)

This bridging study is a randomized, double-blind, two arms parallel group, prospective intervention study. The primary objective of this study is to evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) using new Hepatitis B bulk (Bio Farma).

This bridging study is a randomized, double blind, two arms parallel groups, prospective intervention study. Total 220 infants, 0-3 days old will be involved in this study. The subject will be divided into 2 groups, 110 subjects are the investigational group and 110 subjects are the active comparator group.

The objective of this study is to evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) using new Hepatitis B bulk (Bio Farma) and to asses the safety of DTP-HB-Hib Vaccine (Bio Farma) and Recombinant Hepatitis B Vaccine using new Hepatitis B bulk (Bio Farma).

Eligibility Criteria:
Inclusion Criteria:

1. Healthy, full term, newborns infants.
2. Infant born after 37-42 weeks of pregnancy.
3. Infant weighing 2500 gram or more at birth.
4. Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form.
5. Parents will commit themselves to comply with the indications of the investigator and with the schedule of the trial.

Exclusion Criteria:

1. Child concomitantly enrolled or scheduled to be enrolled in another trial.
2. Child evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature 37.5 celcius degrees on Day 0).
3. Child suspected of allergy to any component of the vaccines (e.g. formaldehyde), based on anamnesis.
4. Child suspected of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection, based on anamnesis
5. Newborn suspected of congenital or acquired immunodeficiency, based on anamnesis
6. Child received or plans to receive any treatment likely to alter the immune response intravenous (immunoglobulins, blood-derived products or long term corticotherapy (\> 2 weeks)).
7. Child received other vaccination with the exception of BCG and poliomyelitis.
8. Child has any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
9. Mother with HbsAg and HIV positive (by rapid test within 30 days prior subject's birth)
10. Mother suspected of immunodeficiency disease based on anamnesis
Balloon Colonoscopy for Incomplete Colonoscopy

Patients with a prior incomplete colonoscopy will be enrolled in this study. Patients will be randomized to either an initial repeat attempt with a standard colonoscope or the single balloon enteroscope. If the procedures is unsuccessful, the patient can be crossed-over to the other group. The primary endpoint of the study is a complete colonoscopy.

Colonoscopy is a well-established practice utilized for the evaluation of lower gastrointestinal tract diseases including, mostly commonly, the screening for colorectal polyps and cancer. Despite improvements in endoscope technology, a significant minority of procedures (up to 10%) can not be safely completed due to a variety of patient factors and technical difficulties. These factors primarily include prior abdominal surgeries resulting in adhesions, severe diverticular disease, inadequate bowel cleansing, and patient discomfort.

Options for an incomplete colonoscopy include several endoscopic and non-endoscopic modalities. Non-endoscopic modalities include radiologic studies such as CT/MRI colonography as well as a retrograde barium study. Relative disadvantages of these modalities is the inability to remove colonic polyps, perform biopsies, and in the case of barium studies, a lower sensitivity for pathology. Alternative endoscopic modalities have been described that may assist in successfully completing colonoscopy Of these alternative methods, balloon-overtube assisted colonoscopy is the most promising, but this method has not been studied in a randomized, controlled fashion. In this study, we aim to compare balloon-overtube assisted colonoscopy versus standard colonoscopy for patients with prior incomplete colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* prior colonoscopy that was incomplete within the previous 12 months or their two most recent colonoscopies (performed at any time interval) were incomplete

Exclusion Criteria:

* incomplete colonoscopy due only to poor bowel preparation or inadequate sedation
Implementation of a Computer-based Questionnaire for Preoperative Evaluation in Anesthesia Ambulance

Preanesthetic evaluation is a clinical assessment process with purpose of increased patient safety. One focus is review of patient medical history to reduce perioperative morbidity and mortality as well as optimize the daily process in at anesthesia ambulance. The aim of that study is the development and implementation of a practical computer-based individualized and risk-adapted questionnaire for the daily routine

The study was a step-by-step process. In the first investigation in 2013 the investigators included 50 patients and 81 patients in 2016. Questionnaires were identical in both testing stages for comparability. Practicability of a computer-based questionnaire on patient medical history, diagnosis as well as behavior guidelines was tested at anesthesia ambulance. Moreover, the investigators evaluated the user satisfaction with the help of a separate anonym paper-based questionnaire in 2013 as well as in 2016.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Patients who undergo a procedure in anaesthesia and elective surgery
* German speaking people

Exclusion Criteria:

* Emergency surgery
* American Society of Anesthesiologists (ASA) classification V and VI
* Patients with guardianship
Acute Effects of Beetroot Juice Ingestion on Cognitive Function and Neuromuscular Performance in Elite Female Taekwondo Athletes

Beetroot juice is a good source of nitrate (NO3-), which is a precursor of nitric oxide (NO) through the NO3- to nitrite (NO2-) to NO pathway (Lundberg et al., 2008). Consequently, it is thought that a minimum threshold may exist for dietary NO3- consumption of at least 5 mmol to enhance athletic performance (Senefeld et al., 2020). In turn, systematic reviews have documented that the use of beetroot juice supplementation enhances muscle strength and power-related attributes (Gonzalez et al., 2023), as well as performance in repeated high-intensity activity bouts (Alsharif et al., 2023; Dominguez et al., 2018). However, beetroot juice supplementation has been shown to have equivocal effects on neuromuscular performance specifically among individual sport athletes (e.g. taekwondo). Thus, the aim of this study was to determine the effects of acute beetroot juice ingestion (140 mL, 12.8 mmol NO3-) on neuromuscular performance in elite female taekwondo athletes.

Beetroot juice is a good source of nitrate (NO3-), which is a precursor of nitric oxide (NO) through the NO3- to nitrite (NO2-) to NO pathway (Lundberg et al., 2008). This pathway is thought to promote increased sarcoplasmic reticulum calcium release and re-uptake with ensuing enhancements in force output within type II muscle fibers (Hernandez et al., 2012), as well as increased neurotransmitter release (Esen et al., 2022) and attenuated muscle potassium efflux (Wylie et al., 2013) that could benefit neuromuscular performance. Consequently, it is thought that a minimum threshold may exist for dietary NO3- consumption of at least 5 mmol to enhance athletic performance (Senefeld et al., 2020). In turn, systematic reviews have documented that the use of beetroot juice supplementation enhances muscle strength and power-related attributes (Gonzalez et al., 2023), as well as performance in repeated high-intensity activity bouts (Alsharif et al., 2023; Dominguez et al., 2018). However, beetroot juice supplementation has been shown to have equivocal effects on neuromuscular performance specifically among individual sport athletes (e.g. taekwondo). Thus, the aim of this study was to determine the effects of acute beetroot juice ingestion (140 mL, 12.8 mmol NO3-) on neuromuscular performance in elite female taekwondo athletes.

Eligibility Criteria:
Inclusion Criteria:

* Age between 16 to 40 years
* Competed in international taekwondo competitions representing her national teams.
* More than6 years of training experience (at least 3 sessions per week).
* Female taekwondo athletes.

Exclusion Criteria:

* Male taekwondo athletes.
Comparison of Intralesional Tranexamic Acid and Platelets Rich Plasma in the Treatment of Melasma

ABSTRACT Objective: To study the efficacy while comparing Intralesional tranexamic acid Vs Platelets rich plasma (PRP) in treatment of Melasma.

Study design: Randomized-controlled trial (RCT). Study setting and duration: Dept of dermatology, CMH-Abbottabad, Nov-2022 /April-2023.

Methodology: The sample size of 60 patients 20 to 40 years were calculated by using Openepi App. The informed consent was taken. The patients were randomly allocated to two groups: Group A (30 patients injected with Intradermal Tranexamic acid (4mg/ml) and Group B (30 patients treated with PRP (1ml) intra-dermally, every fourth week for up to 12 weeks between both groups). The mMASI scale was used to evaluate all patients. The final evaluation was performed on the 24th week of follow-up. For analysis Statistical Package for the social sciences version-27 was used. To determine statistical significance a paired t-samples test with a p-value of \< 0.05 was applied.


Eligibility Criteria:
Inclusion Criteria:

* 20_40 years of age
* suffering from melasma

Exclusion Criteria:

* pregnancy
* breastfeeding mothers
* allergic to tranexamic acid
* bleeding disorders
* warts or facial eczema
Kangaroo Mother Care to Prevent Hypothermia in Term Infants

The overall hypothesis is that better adherence to Kangaroo Mother Care (KMC) in combination with existing WHO thermoregulation care will reduce the incidence of moderate hypothermia (32-36 degrees C) or severe hypothermia (\<32.0 degrees C) in term infants (greater than or equal to 37 weeks of gestational age) when compared with routine WHO thermoregulation alone.

The overall hypothesis is that better adherence to Kangaroo Mother Care (KMC) in combination with existing World Health Organization (WHO) thermoregulation care (warm delivery rooms, immediate drying after birth, KMC whenever possible, early and exclusive breastfeeding, postponement of bathing and weighing, appropriate bundling, and use of air incubator, radiant warmer, or heat mattress if the neonate develops hypothermia) will reduce the incidence of moderate hypothermia (32-36 degrees C) or severe hypothermia (\<32.0 degrees C) in term infants (greater than or equal to weeks of gestational age) when compared with routine WHO thermoregulation alone.

Eligibility Criteria:
Inclusion Criteria:

* Estimated gestational age greater than or equal to 37 weeks
* Delivery in the hospital

Exclusion Criteria:

* Abdominal wall defect or myelomeningocele
* Major congenital anomalies
* Blistering skin disorder
Lugol's Solution in Addition to Acetic Acid During Colposcopy

To assess the benefits of using Lugol's solution in addition to acetic acid during colposcopy in women with cervical dysplasia.


Eligibility Criteria:
Inclusion Criteria:

* women referred for colposcopy due to cervical abnormalities
* written informed consent

Exclusion Criteria:

* pregnant women
* presence of a language barrier
* history of conization or other treatments on the cervix uteri
* iodine allergy
Influence of Perioperative Fluid Therapy on Hemoglobin and Methemoglobin Levels

The objective of the study is to evaluate influence of perioperative fluid therapy on Methemoglobin levels, and to changes in hemoglobin. Further, changes in Methemoglobin will be related to metabolic signs of oxidative stress (changes in blood lactate). Patients undergoing major abdominal surgery will be included into the study.

Increasing plasma volume by intravenous administration of crystalloid and/or colloid solutions may cause a relative reduction in hemoglobin (Hb) concentration, a situation that is termed 'dilutional anemia'. Such hemodilution may lead to an iatrogenic reduction in oxygen-carrying capacity and the development of organ dysfunction. Paradoxically, large amounts of fluids that are administered with the aim of increasing oxygen delivery (DO2), as is frequently done as part of perioperative goal-directed therapy; this may lead to an actual decrease in the DO2 due to a decrease in Hb concentration.

Another potential parameter that may reflect the development of dilutional anemia is methemoglobin (MetHb), a form of Hb with reduced ability for oxygen binding. Experimental studies showed that dilutional anemia may lead to up-regulation of perivascular nitric oxide synthase (NOS) and increase NOS-derived nitric oxide (NO) leading to local vasodilation and oxidization of Hb to MetHb. MetHb may potentially serve as a biomarker of 'anemic stress' associated with reduced tissue perfusion during acute hemodilution.

Eligibility Criteria:
Inclusion Criteria:

* major abdominal surgery
* informed consent

Exclusion Criteria:

* violation of study protocol
Uric Acid and Long-term Outcomes in Chronic Kidney Disease

Patients in the earlier stages of Chronic kidney disease (CKD) are at risk both for the development of end-stage renal disease (ESRD) (define by the requirement for dialysis or kidney transplantation) and development of cardiovascular disease (CVD). Although controversial, there is literature to suggest that uric acid may play a role in the progression of kidney disease and development of cardiovascular disease (CVD). The Modification of Diet in Renal Disease (MDRD) Study was a randomized controlled trial in patients with CKD, which examined the effects of dietary protein restriction and strict blood pressure control on progression of non-diabetic CKD. Extensive data on risk factors for progression of kidney disease and development of CVD are available, as is long term follow up. 838 of the 840 patients who were randomized have uric acid levels measured at baseline. The aims of the present study are to examine the determinants of uric acid in cross sectional analysis at baseline, to determine the association between uric acid and development of ESRD, and the association of uric acid with all-cause and CVD mortality.

Level of kidney function will be a major determinant of uric acid levels independent of other risk factors.

Level of uric acid will be associated with development of ESRD independent of level of kidney function and other risk factors.

Uric Acid levels will be associated with both all-cause and CVD mortality independent of kidney function and other risk factors.


Eligibility Criteria:
Inclusion Criteria:

* between 18 and 70 years of age
* with serum creatinine of 1.2 to 7 mg/dl in women and 1.4 to 7 mg/dl in men

Exclusion Criteria:

* pregnancy
* Type I diabetes
* insulin dependent type II diabetes
* renal artery stenosis
* proteinuria greater than 10mg/day
* mean arterial pressure greater than 125 mmHg
* prior kidney transplant
Tongue Muscular Assessment in Children (TMAC) - Reproducibility Testing

This study aims to assess intra-rater and inter-rater reliability in measuring tongue motor skills in children.

Several motor skills of the tongue can be described: tongue elevation, swallowing, and protrusion. They are all relevant for a wide array of disorders, including neurological, musculoskeletal, and respiratory conditions. An ongoing study by our team is attempting to collect normative data on these motor skills in a pediatric cohort (NCT06166680). From this ongoing study, 56 subjects will be selected to assess the intra-rater and inter-rater reliability in measuring these motor skills.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 4 and 17 years old

Exclusion Criteria:

* Eating disorder
* Dysphagia
* Cardiorespiratory disorder
* Neurological disorder (including neuromuscular disorders)
* Previous or ongoing obstructive sleep apnea-hypopnea syndrome
* Previous or ongoing cancer of the head or neck
* Previous oral or pharyngeal surgery (except for the surgical removal of wisdom teeth)
* Cranial, oral or upper airway malformation (ex.: nasal cavities, pharynx)
* Previous or ongoing orthodontic treatment (e.g. braces)
* More than 33% of positive answers to the Pediatric Sleep Questionnaire (≥ 8/22)
Safety and Efficacy Study Evaluating Dimebon in Patients With Mild to Moderate Alzheimer's Disease on Donepezil

The purpose of this study is to determine if Dimebon is safe and effective in patients with mild to moderate Alzheimer's disease on Donepezil.


Eligibility Criteria:
Inclusion Criteria:

* Mild-to-moderate Alzheimer's disease (AD)
* Probable AD (Diagnostic Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR))
* Mini-Mental State Examination (MMSE) score between 12 and 24, inclusive
* Stable on donepezil for at least 6 months

Exclusion Criteria:

* Other causes of dementia
* Major structural brain disease
* Unstable medical condition or significant hepatic or renal disease
Impact of Heart Rate Variability Modulation on Stress Management Among Physicians

The purpose of this research is to examine a wearable device called Apollo that emits gentle vibrations found to benefit mood, energy, and focus. We want to understand how it affects burnout in physicians.

This study will be conducted by using a Tuned Vibroacoustic Stimulation (TVS) device(the commercially available TVS device known as the Apollo wearable), that has been shown in clinical studies at University of Pittsburgh to improve heart rate variability and recovery under stress. The Apollo wearable generates low volume sound waves that feel like a soothing touch to the skin. This study will assess whether slight modulation of heart rate variability (HRV) will result in a reduction in stress, improved recovery, and recovery in and around the hospital. Physicians will wear the Apollo device for heart rate variability modulation and complete questionnaires before and after use of the Apollo device for comparison of outcomes.

Eligibility Criteria:
Inclusion Criteria:

* UPMC attending physicians and residents. The participants must have either IOS or Android phones.

Exclusion Criteria:

* Unwillingness or inability to participate in the study
* Currently own an Apollo device
Microfracture vs. Microfracture and BMAC for Osteochondral Lesions of the Talus

Osteochondral lesions of the talus are thought to be due in large part to traumatic events or repetitive microtrauma that causes damage to both the articular cartilage and the subchondral bone. There are several treatment modalities for osteochondral lesions of the talus but there is no consensus as to which is the superior method for repair.

Treatment modalities are aimed at regenerating articular cartilage. Microfracture is a widely accepted and utilized treatment for osteochondral lesions. This procedure results in pluripotent bone marrow stem cells filling the defect and ultimately differentiating into fibrocartilage-producing cells \[1\]. This technique has shown good results in both short- and medium-term follow-up for smaller lesions. Bone marrow aspirate contains mesenchymal stem cells and growth factors with cartilage regeneration potential. Bone marrow aspirate concentrate (BMAC) is a treatment modality that has shown to have to potential to produce hyaline cartilage. This study aims to analyze the effect of adding BMAC to the standard microfracture procedure in terms of clinical and radiographic outcomes in comparison to patients who only underwent microfracture treatment.


Eligibility Criteria:
Inclusion Criteria:

Greater than 18 years of age and scheduled for surgery to treat osteochondral lesion of the talus Able and willing to sign informed consent document

Exclusion Criteria:

Unwilling to sign informed consent document
Blood Pressure Following Isometric Exercise in Inactive Adults

This study investigates how isometric exercise training (IET) affects blood pressure in physically inactive adults. Isometric exercise involves sustained muscle contractions without movement-for example, pushing against a fixed object. Previous research has shown that IET may help reduce blood pressure, but the mechanisms involved are not fully understood.

The purpose of this study is to assess both the immediate (acute) and long-term (chronic) effects of IET on cardiovascular outcomes. Participants will complete a series of lab-based exercise sessions over several weeks. In these sessions, they will perform repeated bouts of isometric leg extensions while seated on an exercise machine designed to measure muscle force.

Throughout the study, researchers will monitor participants' blood pressure, heart rate, and muscle activity. Acute responses-such as post-exercise hypotension (a short-term drop in blood pressure)-will be measured immediately after exercise. Chronic changes, such as resting blood pressure improvements, will be evaluated across the training period.

Additional measurements will include heart rate variability (HRV), which gives insight into autonomic nervous system activity, and electromyography (EMG), which tracks muscle fatigue and activation patterns. These data will help explore potential mechanisms behind the cardiovascular benefits of IET.

By examining how repeated sessions of isometric exercise influence blood pressure and related physiological responses, this research may support the use of IET as a non-pharmacological strategy for managing or preventing hypertension in physically inactive individuals.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Self-reported physically inactive or insufficiently active (not meeting current physical activity guidelines)
* Not currently engaged in structured resistance or isometric exercise training
* Able to attend lab sessions over a 4-week period
* Provides written informed consent

Exclusion Criteria:

* Current diagnosis of hypertension requiring medication
* Any known cardiovascular, neurological, or musculoskeletal condition contraindicating isometric exercise
* Formal education or professional background in exercise science, physiology, or a related field
* Pregnant or planning to become pregnant during the study period
* Inability to follow verbal instructions or complete study protocols
Memory Enhancement by Gamma-hydroxybutyrate vs. Trazodone in Major Depressive Disorder.

30 healthy adults and 30 patients with major depressive disorder, will take part in three single-application pharmacological interventions (GHB vs. Trazodone vs. placebo p.o.) to test potential effects of these drugs on nocturnal memory consolidation. All participants will be assessed with mood state questionnaires, tests of emotional, procedural and declarative memory consolidation, polysomnography, EEG and neuroinflammatory biomarkers. At experimental nights, learning tasks are performed prior to sleep. The next morning, recalling tasks are performed. Each subject will pass through 5 study nights (1 screening, 1 adaptation and 3 experimental nights).


Eligibility Criteria:
Arm 1 (healthy controls):

* Healthy participants,
* Non-smoker,
* Age 20-65 years

Arm 2 (patients with depression):

* Diagnosis of major depression (DSM-V),
* Selective Serotonin-Reuptake-Inhibitor (SSRI) or Selective Serotonin-Noradrenalin-Reuptake-Inhibitor (SSNRI) medication,
* Age 20-65 years