cyrilzakka/clinical-trials huggingface dataset:
Investigation of Supragingival Plaque Microbiome in Early Childhood Caries

The purpose of this study was to characterize the supragingival plaque microbiome in children with early childhood caries and identify potential microorganisms associated with caries.

Sixty children with and without early childhood caries were recruited from Trakya University Faculty of Dentistry Department of Pediatric Dentistry. Oral examinations were performed by the same examiner according to diagnostic criteria of World Health Organisation (WHO) and The International Caries Detection and Assessment System (ICDAS) . Mothers' completed a structured questionnaire on the socio-demographic informations, child's feeding practices and oral hygiene habits. After the oral examination, supragingival plaque samples were collected from the posterior tooth surfaces. Supragingival plaque samples were examined with the Illumina MiSeq new generation sequencing method.

Eligibility Criteria:
Inclusion Criteria:

* 36-71 months old children
* No history of any medical problem
* No history of antibiotic in the three months prior to sampling
* Any sign of early childhood caries,
* Caries free children
* Mothers accepted to complete a structured questionnaire
* Children who cooperate for dental examination and sample collection

Exclusion Criteria:

* Children older than 71 months
* Medically compromised
* Children with antibiotic use history at last three months
* Children refused dental examination and plaque collection
* Mothers' refused to complete questionnare
Monster Screw System Post-Market Clinical Follow-Up Study

Post-market clinical follow-up study on the Monster Screw System

Ambispective, multi-surgeon, single site, consecutive case series to determine the safety, performance, and benefits of the Monster Screw System.

Eligibility Criteria:
Inclusion Criteria:

* The subject has undergone a foot and/or ankle procedure using the Monster Screw System and completed by one of the investigators.
* The subject has adequate radiographic and medical records

For the Prospective Data Collection:

- The subject is willing to provide written informed consent

Exclusion Criteria:

-None
The Impact of a Fast Diet and Calorie Mimetic Supplements on Epigenetic Aging

This is a prospective randomized clinical study of 50 patients to evaluate the fasting mimicking diet program by Prolon with a calorie mimetic supplement from Peak Human Labs. This study will be evaluating the effectiveness of the combined intervention over a three month program.

The study will assess the effects that the program has on the participants' biological aging.


Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals
* Age \> 16 years
Sugammadex Reversal of Neuromuscular Blockade and Postoperative Bleeding

Sugammadex is new drug that is used for reversal of rocuronium induced muscle relaxation. benefits of reversal of neuromuscular blockade appears to be of great value in living donor liver transplant recipients. However, Few Clinical reports have investigated the anticoagulant effect of sugammadex. In this study, effects of sugammadex on bleeding profile of living donor liver transplantation will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* all candidates for living donor liver transplantation

Exclusion Criteria:

* massive intraoperative bleeding manifestations of early graft dysfunction
Fatigue and Cognitive Demand With Aging

This study will determine the influence of a cognitive task performed during fatiguing contractions.

Individuals will participate in one familiarization session followed by 3 randomized experimental sessions (crossover design).

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals aged between 18-35 and 65-90

Exclusion Criteria:

* Metal implants or joint replacement. neuromuscular disease
tDCS for Multiple System Atrophy With Cerebellar Feature

The aim of study is to investigate most effective site for control the motor coordination using transcranial direct current stimulation in multiple system atrophy with cerebellar feature

Participants receive transcranial direct current stimulation (tDCS) over M1, cerebellar cortex or sham stimulation for 30 minutes. The type of stimulation depends on random assignment. The participants have a 1 week of wash out period between each stimulation.

The assessment will be done by International Cooperative Ataxia Rating Scale (ICARS), GAITRITE (CIR Systems Inc., Clifton, New Jersey, USA) and PEDOSCAN (DIERS PEDO, Germany) at baseline and immediately after each treatment.

Eligibility Criteria:
Inclusion Criteria:

* 1. Patients who meet the clinical criteria for probable multiple system atrophy with cerebellar features (MDS second consensus statement on the diagnosis of multiple system atrophy)
* 2. Patients aged between 40 and 70
* 3. Patients who do not have rigidity and bradykinesia
* 4. Patients who have given voluntary consent after understanding the content of the clinical trial

Exclusion Criteria:

* 1. Patients with a serious cognitive disorder, behavioral disorder, or mental illness
* 2. Patients have history of seizure, stroke, encephalitis, other degenerative neurological disease
* 3. Patients with a serious medical disease

  * Patients who concomitantly suffer from severe renal impairment, convulsions, stomach ulcers, moderate or more severe liver disease
  * Patients with un-controlled high blood pressure or diabetes
* 4. Patients who have taken another investigational products within 4 weeks prior to being enrolled in this clinical trial, or patients who are pregnant or breastfeeding
Plasma Citrulline in Preterm With NEC

Aim of study

Introduction

Eligibility Criteria:
Inclusion Criteria:

* preterm neonates \< 35 weeks Preterm neonates\< 2kg Preterm neonates diagnosed with necrotizing enterocolitis

Exclusion Criteria:

* renal dysfunction Inborn error of metabolism Congenital malformation
Effect of Soleus Pushup Exercise in Type 2 Diabetes Patients

The aim of this research is to compare the immediate effects of one hour Soleus Pushup Exercise and treadmill walk in Type 2 Diabetic population on blood glucose level. Randomized controlled trials done at Railway General Hospital and diabetic centers of Rawalpindi and Islamabad.. The sample size was 66. The subjects were divided in two groups, 33 subjects in Soleus Pushup Exercise group and 33 subjects in treadmill walk group. Study duration was of 6 months. Sampling technique applied was non probability convenience sampling technique. Only 40-60 years diabetic people with clinically diagnosed type 2 Diabetes for upto 10 years were included. Tools used in the study are Glucometer

Diabetes is on the rise worldwide, with a global prevalence in adults in 2021 being 537 million adults (20-79 years) living with diabetes -one in ten. This number is predicted to rise to 643 million by 2030 and 783 million by 2045. Over 3 in 4 adults with diabetes live in low- and middle-income countries. Although physical activity (PA) is a key element in the prevention and management of type 2 diabetes. Structured interventions combining Physical Activity and modest weight loss have been shown to lower type 2 diabetes risk by up to 58% in high-risk populations. The increase in T2DM prevalence can only partly be attributed to the increasing prevalence of obesity and a sedentary lifestyle. The exercise recommendations for individuals with type 2 diabetes are similar as for the general population, suggesting a minimum of 150 min of moderate-vigorous-intensity aerobic exercise each week. However, the general population doesn't adhere to these guidelines.

The goal of treatment in type 2 diabetes is to achieve and maintain optimal BG, lipid, and blood pressure (BP) levels to prevent or delay chronic complications of diabetes. A fundamental principle in exercise physiology is that a small muscle mass working in isolation can achieve a higher local oxygen consumption (VO2/min per kg) than when recruiting a large muscle mass. The soleus (1% body mass) has a highly pennated architecture favoring greater amounts of muscular work during plantarflexion. It has an exceptionally high physiological cross-sectional area (3-8 times more than most of the 20 other limb muscles studied).

Eligibility Criteria:
Inclusion Criteria:

* • Both male and female individuals

  * Individuals with age between 40 to 60 years
  * Individuals with clinically diagnosed diabetes type 2 up to 10 years
  * individuals not engaged in a structured walking/exercise program
  * 2 hours post meal with glucose ranging upto 200.

Exclusion Criteria:

* • No recent or planned changes in diet, physical activity, or medications.

  * Participants diagnosed with pre-diabetes, gestational diabetes, or type 1 diabetes
Does Obesity Influence Women Cardiorespiratory Fitness and Daily Physical Activities? (ACTIVOB)

Many obese individuals experience difficulties in executing household activities. In this study, we investigate the cardiorespiratory fitness (CRF) of obese vs. non-obese women, and the impact of obesity on cardiorespiratory functioning during daily household activities.

Methods: On 48 sedentary female subjects will be assessed by cardiorespiratory exercise testing with evaluation of peak oxygen uptake (⩒O2), heart rate (HR) and maximal cycling power output. Next, cardiorespiratory functioning will be assessed during household activities such as ironing (A1), cleaning floor (A2), walking and climbing stairs (A3).

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI = weight in kilograms/(height in meters) x (height in meters)) as: healthy obese (OB group (OB); BMI between 30 to 39.9 kg.m-2; n = 20), and healthy non obese (NO group (NO); BMI between 18.5 to 24.9 kg.m-2; n = 28).

Exclusion Criteria:

* comorbidities (other than obesity) :

  1. history of systemic hypertension or antihypertensive medication, diabetes mellitus, cardiovascular or respiratory disease, systemic disease, smoking;
  2. any drugs;
  3. BMI \>40 kg.m-2;
  4. having a regular physical activity.
Combined Use of Respiratory Devices After Thoracic Surgery

In a rehabilitation setting, respiratory muscle training with re-expansion techniques in patients following cardio-thoracic surgery represents a consolidated intervention. New devices called RESPILIFT® and RESPIVOl® improve deep inspiration and pulmonary volume with an effect on respiratory muscle performance and perceived dispnoea. The aim of the investigators study is to test the clinical efficacy of RESPILIFT® and RESPIVOl® in patients with a recent history of cardio-thoracic surgery.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old
* recent cardio-thoracic surgery (\< 30 days of admission)
* compliance to pulmonary rehabilitation program

Exclusion Criteria:

* clinical instability
* concomitant severe co-morbidities
* inability to use respiratory devices
Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection

The primary objective of this study is to assess the rates of HIV-1 infection in Men (MSM) and transgender women (TGW) who have sex with men and who are administered daily emtricitabine/tenofovir alafenamide (F/TAF) or emtricitabine/tenofovir disoproxil fumarate (F/TDF) with a minimum follow-up of 48 weeks and at least 50% of participants have 96 weeks of follow-up after randomization.


Eligibility Criteria:
Key Inclusion Criteria:

* Must be at high risk of sexual acquisition of HIV
* HIV-1 negative status
* MSM and TGW (male at birth) who have at least one of the following:

  * condomless anal intercourse with at least two unique male partners in the past 12 weeks (partners must be either HIV-infected or of unknown HIV status)
  * documented history of syphilis in the past 24 weeks
  * documented history of rectal gonorrhea or chlamydia in the past 24 weeks
* Adequate renal function: estimated glomerular filtration rate ≥ 60 mL/min according to the Cockcroft-Gault formula
* Adequate liver and hematologic function:

  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN) and total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
  * Absolute neutrophil count ≥ 1000/mm\^3; platelets ≥ 75,000/mm\^3; hemoglobin ≥ 10 g/dL

Key Exclusion Criteria

* Grade 3 or Grade 4 proteinuria or glycosuria that is unexplained or not clinically manageable.

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Posterior CAD/CAM Cobalt-chromium Alloy Single Crowns: 4-year Prospective Clinical Study

Objectives - To evaluate the 4-year clinical outcomes of ceramic veneered Computer Aided Design/Computer Aided Manufacturing (CAD/CAM) Co-Cr single crowns supported by natural teeth in posterior regions.

Material and methods - Eighty-nine patients were provided with 120 ceramic veneered CAD/CAM Co-Cr single crowns replacing either premolars and molars. Specific inclusion criteria were needed and tooth preparations were standardized and performed by 2 expert prosthodontists. CAD/CAM Co-Cr frameworks were fabricated and veneered with ceramics. The restorations were cemented using a eugenol-free zinc oxide luting agent. The patients were recalled after 1, 6, 12, 24, 36 and 48 months. The survival and success of the restorations were evaluated. The technical and esthetic outcomes were examined using the United States Public Health Service criteria. The biologic outcomes were analyzed at abutment and contralateral teeth and descriptive statistics were performed.


Eligibility Criteria:
Inclusion criteria:

* good general health
* American Society of Anesthesiologists (ASA) ASA I or ASA II condition; periodontal health
* Angle class I occlusal relationship
* minimum of 10 couples of opponent teeth
* good oral hygiene
* no evident signs of parafunctions and/or temporomandibular disorders.
* periodontal health of abutment teeth (absence of tooth mobility, absence of furcation involvement);
* proper positioning of abutment teeth in the dental arch (tooth axis adequate for a SC)
* sufficient occlusal-cervical height of the clinical crown of abutment teeth (≥ 4 mm) for the retention of a SC
* vital or endodontically treated to a clinically sound state abutment teeth;
* abutment teeth opposing natural teeth.

Exclusion criteria:

* high caries activity
* presence of periodontal disease on the abutment tooth
* occlusal-cervical height of the abutment tooth \< 4 mm
* reduced interocclusal distance or supraerupted opposing teeth
* unfavorable crown-to-root ratio
* severe were facets, clenching and/or bruxism
* presence of removable partial dentures (RPDs)
* pregnancy or lactation
* alcohol and/or drug addiction
Safety and Efficacy Evaluation of IM19 CAR-T Cells

Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With CD19+ B-cell leukemia or CD19+ B-all.

Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With CD19+ B-cell leukemia or CD19+ B-ALL patients and determine the MTD,LTD and the best dosage.

Eligibility Criteria:
Inclusion Criteria:

* Patients with CD19+ leukemia, meeting the following criteria

  * At least 2 prior combination chemotherapy regimens (not including single agent monoclonal antibody (Rituximab) therapy)
  * Less than 1 year between last chemotherapy and progression
  * Not eligible or appropriate for allo-HSCT
* To be aged 4 to 65 years
* Estimated survival of ≥ 6 months, but ≤ 2 years
* ECOG score ≤2
* Relapse after auto-HSCT
* Women of childbearing potential must have a urine pregnancy test taken and proven negative prior to the treatment. All patients agree to use reliable methods of contraception during the trial period and until follow-up for the last time.
* Voluntary participation in the clinical trials and sign the informed consent.

Exclusion Criteria:

* History of epilepsy or other CNS disease
* Patients have GVHD, which needs treatment with immunosuppressive agents
* Patients with prolonged QT interval or severe heart disease
* Patients in pregnancy or breast-feeding period
* Uncontrolled active infection
* Active hepatitis B or hepatitis C infection
* Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary
* Previously treatment with any gene therapy products
* Feasibility assessment during screening demonstrates \<30% transduction of target lymphocytes, or insufficient expansion (\<5-fold) in response to CD3/CD28 costimulation
* ALT /AST\>3 x normal value; Creatinine\> 2.5 mg/dl; Bilirubin \>2.0 mg/dl
* Any uncontrolled medical disorders that the researchers consider are not eligible to participate the clinical trial
* HIV infection
* Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
DBT Skills Groups for Veterans at High Risk for Suicide Attempt

Veteran suicide death is a national crisis. Risk factors include emotion dysregulation, which occurs across mental health disorders. Dialectical behavior therapy (DBT) is an evidence-based suicide intervention that targets emotion dysregulation but is resource-intensive and not widely available at VHA. A more efficient evidence-based DBT Skills Group (DBT-SG) is associated with reduced suicidal ideation and emotion dysregulation and likely more feasible to implement at VHA. This is a randomized controlled trial to test whether DBT-SG in addition to VHA treatment-as-usual, compared to only VHA treatment-as-usual, reduces Veteran emotion dysregulation.

This is a randomized controlled trial at four VHA medical centers. Veterans will be randomized to VHA treatment-as-usual or VHA treatment-as-usual plus DBT-SG.

Eligibility Criteria:
Inclusion Criteria:

* Veteran eligible for VHA care at participating site
* two or more suicide attempts in lifetime, with one in past 12 months, on Columbia-Suicide Severity Rating Scale (C-SSRS)
* current suicidal ideation (endorsing a suicidal ideation scale of at least 1 \[passive ideation\] on C-SSRS
* emotion dysregulation (score 95 or greater on DERS)
* can attend group sessions
* willing to provide contact information for at least one person who can help locate the participant if study staff are unable to contact them (information for three contact persons will be requested; a participant must provide at least one contact person's information to be included in the study)
* access to telephone; if insufficient access to videoteleconference and local facility is using remote procedures for study, willing to request access to VA-provided device

Exclusion Criteria:

* significant cognitive impairment (score \< 28 on modified Telephone Interview for Cognitive Status (mTICS)
* inability to read English or communicate in spoken and written English
* plan to move away or be unavailable in the next 18 months
Evaluating the Human Immune Response to the JYNNEOS Vaccine

This study is designed to evaluate the magnitude and duration of the human adaptive immune response to the JYNNEOS Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine in the blood, lung mucosa, skin and bone marrow.

Orthopoxvirus vaccination leads to very high magnitude antigen-specific T cell responses and neutralizing antibody responses that can be detected in blood decades after vaccination. Despite a large number of previous studies of human immune responses to Modified Vaccinia Ankara (MVA) vaccination in blood, very few of these previous studies evaluate the human mucosal immune response to MVA in the lung and skin, or the immune response to MVA vaccination in the bone marrow. The development of methods to explore human immune responses in these key immunologic compartments now allows the evaluation of the induction of immune responses in these human tissues using the MVA vaccine system.

Eligibility Criteria:
Inclusion Criteria:

* 18-60 year old otherwise healthy participants

Exclusion Criteria:

* Prisoners
* Participants unable to provide full written informed consent
* Previous receipt of a smallpox or monkeypox vaccine
* Previous infection with monkeypox
* Receipt of any vaccine in the 28 days prior to the first study procedure or planned receipt of any vaccine outside of those provided in the current study before completion of the study day 42 visit.
* Immunocompromise (primary or secondary due to other medical conditions or medications)
* Previous organ transplant
* Active malignancy
* Pregnancy
* \< 4 weeks post-partum or actively breastfeeding
* Female participants who are not actively on hormonal contraception or do not have an intrauterine device in place
* Body Mass Index \> 40
* Current smokers
* History of a known chronic pulmonary, cardiovascular, renal, hepatic, hematologic or metabolic disorder. Participants with isolated treated hypertension as the only cardiovascular disorder may be included in the study.
* History of a chronic neurologic or neurodevelopmental condition. This does not exclude potential participants with chronic back pain or previous disk herniation/back surgery, only participants with documented weakness, quadriplegia or paraplegia. This exclusion criterion also does not exclude from the study participants with recurrent migraine headaches as the only chronic neurologic condition.
* Pulse oxygen saturation value of 92% or less on room air at study enrollment or on the day of bronchoscopy
* Any significant infiltrate or pleural effusion on upright posterior-anterior and lateral chest x-ray imaging performed on the day of bronchoscopy
* International Normalized Ratio value greater than 1.4 or a Partial Thromboplastin Time value of greater than 40 seconds at study enrollment
* Platelet count of less than 100,000 at study enrollment
VAXZEVRIA Japan Post-Marketing Surveillance (PMS) for the Long-term Safety of VAXZEVRIA

This survey will be conducted for the subjects who participate in the priority survey (cohort survey) conducted by the Scientific Research Group of the Ministry of Health, Labour and Welfare at the initial stage of administration of the COVID-19 vaccination. The present study aims to collect information on serious adverse events or COVID-19 infection observed from 28 days after the last vaccination of VAXZEVRIA up to 12 months after the last vaccination and to evaluate the long-term safety of this vaccine.

This survey will be conducted for the subjects who participate in the priority survey (cohort survey) conducted by the Scientific Research Group of the Ministry of Health, Labour and Welfare at the initial stage of administration of the COVID-19 vaccination.

The present study aims to collect information on serious adverse events (including Thrombosis in combination with thrombocytopenia, Immune-mediated neurological conditions, Vaccine-associated enhanced disease (VAED) including Vaccine-associated enhanced respiratory disease(VAERD), Thrombosis or other diseases) or COVID-19 infection observed from 28 days after the last vaccination of VAXZEVRIA up to 12 months after the last vaccination and to evaluate the long-term safety of this vaccine.

Eligibility Criteria:
Inclusion Criteria:

The subjects who participated in the cohort study conducted by the Scientific Research Group of the MHLW and those who give written consents for this study.

Exclusion Criteria:

None