cyrilzakka/clinical-trials huggingface dataset:
YOGA Asanas and Myofascial Chain Activity in Elderly Individuals

Aging is a differentiation process with chronological, biological, psychological and social characteristics, which occurs in the intrauterine period and ends with death. With aging, the structures and functions of tissues are affected and there is a decline in overall physical performance. Asanas in yoga use tonic muscle contraction coordinated with breath control and kinesthetic awareness, which saves energy compared to phasic muscle contraction often observed in physical exercises. We have not encountered a study examining the effect of asanas on muscular activity in old age. Our study will provide support to the literature in this direction.

The study will be carried out on volunteers after the approval of the ethics committee. Before the research, individuals and / or their relatives will be informed about the purpose and content of the study. Participants will first start in mountain (Tadasana) asana. They will then be asked to come to the following asanas in a randomized order. In each of the asanas, you will statically pause for 15 seconds and repeat the movement three times. Participants will rest for 2 minutes between asanas. If deemed necessary during the application, modifications will be made in the movements and security measures will be taken. Warrior 2, elongated triangle, and Light Cluster stances will be evaluated for each limb separately. Muscle activations of individuals to the contralateral external oblique abdominal and ipsilateral adductor longus muscles of the anterior oblique myofascial chain lines and the contralateral latissimus dorsi and ipsilateral biceps femoris long head muscles to the posterior oblique myofascial chain lines will be evaluated using superficial EMG.

Eligibility Criteria:
Inclusion Criteria:

* community-dwelling male and female volunteers who do not do high-level exercise or take frequent long walks and do yoga

Exclusion Criteria:

* Active angina, uncontrolled hypertension, high resting heart rate or respiratory rate, unstable asthma, or exacerbated COPD; cervical spine instability or other significant neck injury, rheumatoid arthritis, unstable ankle, knee, hip, shoulder, elbow or wrist joints, hemiparesis or paraparesis, movement disorders (eg, Parkinson's disease), peripheral neuropathies, residual defective stroke, and severe vision or hearing problems, use of a walker or wheelchair, insufficient hearing to ensure safety in a yoga group setting
Cold or Hot Snare Endoscopic Mucosal Resection for 10-19mm Non-pedunculated Colorectal Polyps

This is a prospective, randomized, open-label, non-inferiority, multiple-center trial. Outpatients who are scheduled to undergo colonoscopy and found eligible polyps will be randomized to receive either cold snare endoscopic mucosal resection (CS-EMR) or hot snare endoscopic mucosal resection (HS-EMR). This study aims to compare the efficacy and safety of CS-EMR or HS-EMR for the resection of non-pedunculated colorectal polyps sized 10-19mm.


Eligibility Criteria:
Inclusion Criteria:

* 18-80 years of age;
* undergo colonoscopy in the Digestive Endoscopy Center of Peking Union Medical College Hospital, Beijing Tsinghua Changgung Hospital or Seventh Medical Center, General Hospital of the Chinese People's Liberation Army;
* volunteer to participate in this study and sign informed consent;
* at least one polyp sized 10-19 mm (Paris classification Is or IIa) by colonoscopy.

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) status class 3 or above;
* poor bowel preparation (Boston bowel preparation scale \< 6 points);
* known or endoscopic features indicating the submucous infiltration or malignancy;
* oral anti-coagulants, or antiplatelet agents, or known blood coagulation disorders, or bleeding tendency (platelets\<50000 cells/mm3 or INR\>1.5);
* a history of colorectal resection;
* emergency colonoscopy (hemodynamic instability and/or continued active gastrointestinal bleeding and/or requiring intensive care patients);
* inflammatory bowel disease, familial polyposis, and colorectal cancer;
* pregnancy or lactation;
* severe cardiopulmonary dysfunction, liver cirrhosis, chronic kidney disease, other malignant tumors, or severe infectious diseases.
Efficacy and Safety of Biphasic Insulin Aspart 30 in Combination With Metformin in Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to investigate the efficacy on blood glucose control in type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes for at least 6 months
* Insulin naive. Short term insulin treatment (7 days or less within the last 6 months) is allowed
* Previous treatment with oral antidiabetic drugs for at least 4 months
* Judged by the investigator to be eligible for an insulin analogue plus oral antidiabetic drug treatment regimen
* BMI below 40 kg/m2
* HbA1c between 7-12%
* Able and willing to perform self-plasma glucose monitoring

Exclusion Criteria:

* The receipt of any other investigational drug within 4 weeks before screening
* A history of drug or alcohol abuse within the last 12 months
* Severe, uncontrolled hypertension
* Known or suspected allergy to trial products or related products
The Benefit in Terms of Improvement in Haemoglobin Level At 6 Months in Premature Babies Receiving Alternate Iron Substitution 4 Times a Week Compared to a Daily Substitution

BienFer is a double-blinded randomized controlled trial about iron substitution and abdominal pain. Premature babies and low birth weight babies have lower iron stores than term newborns and are therefore at greater risk of iron deficiency and anemia. Iron deficiency could have consequences for cerebral development. Ferric substitution reduces the risk of iron deficiency and anemia. It is common to replace premature babies with iron substitution between 2 weeks and 6 months of life. In practice, the medical staff notice that newborn with iron substitution have abdominal pain and constipation. A study in the adult population shows that alternate iron supplementation versus daily supplementation improved iron absorption, with no difference in hemoglobin level and decrease abdominal pain. Studies in children shows that intermittent iron supplementation do not change hemoglobin and ferritin level and improve adherence. There is no data comparing daily versus alternate supplementation in premature babies.

The aim of the study is to evaluate if alternate (4 times/week) iron supplementation is equivalent to daily iron substitution for hemoglobin values in premature babies between 28 0/7 weeks amenorrhea (WA) and 34 6/7 WA, and if it reduces abdominal discomfort and inflammation, and if it improves compliance.


Eligibility Criteria:
Inclusion Criteria:

* Premature babies between 28 0/7WA and 34 6/7 WA
* Parental consent, postnatal
* Age of 2 weeks

Exclusion Criteria:

* anemia \< 80g/l at 2 weeks of age
* Intraventricular Hemorrhage stage III and IV
* Necrotizing Enterocolitis
* Enteral feeding less than 100ml/kg/j after 2 weeks of life
* Congenital disorder
Pharmacokinetic Evaluation of an Intensified and Decreasing Dosing Regimen of Mycophenolate Sodium in Combination With Tacrolimus Post Kidney Transplant: The Myfortic Study

Mycophenolate acid (MPA) has been developed and approved in combination with cyclosporine and has been used in kidney transplantation for more than a decade. At present, combination of tacrolimus and mycophenolate acid tends to be considered as the standard of care for maintenance immunosuppression in kidney transplantation. Mainly due to a different effect on the entero-hepatic recycling pathway, cyclosporine and tacrolimus differently interfere with MPA clearance. When used with tacrolimus, MPA dosage has thus to be adjusted and cannot be extrapolated from what is recommended for a cyclosporine-based treatment. However, there is currently no clear guideline for MPA dosing when this drug is used in combination with tacrolimus. This is potentially detrimental for patients since under-or overexposure of MPA has been clinically linked to the outcome of transplantation.

The purpose of this study is to pharmacologically validate an original MPA dosing regimen in combination with tacrolimus within the three months post-kidney transplant. This regimen consists in an intensified dosing of mycophenolate sodium during the earliest period of transplantation in order to rapidly reach the appropriate MPA blood exposure followed by a gradual decrease in dose in order to prevent MPA overexposure.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years
* Renal transplant from a dead or alive donor.
* Patients treated by initial quadritherapy with basiliximab, tacrolimus, steroid et mycophenolate sodic
* ΒHCG pregnancy test negative at the initiation of Myfortic ®
* Effective contraception during treatment and up to 6 weeks after treatment with Myfortic ®

Exclusion Criteria:

* Patient at high risk of rejection of a transplant
* IMC \> ou = 30
* Platelets \< 75000 / mm3 and/or neutrophils \< 1500 / mm3 and/or leukocytes \< 2500/ mm3 and/or hemoglobin \< 6 g/dL.
* Patient requiring a anti-CMV prophylaxis by valganciclovir.
* Pregnancy or breast feeding.
Employing End Tidal Capnography in Continuous Flow Ventricular Assist Device Patients

The purpose of this study is to explore how the End Tidal Carbon Dioxide monitoring via nasal cannula (ETCO2-NC) device may allow for earlier detection of respiratory complications. This device will detect the amount of carbon dioxide exhaled with each breath and may better predict high levels of this than traditional monitoring. This may reduce the number and severity of respiratory issues. A convenience sample of 60 participants either scheduled for continuous flow left ventricular assist device (CF-LVAD) implant or who have been readmitted to an ICU with a CF-LVAD will be recruited and randomized to usual care or usual care plus ETCO2-NC throughout their stay in the ICU.

The purpose of this proposal is to explore the relationships between End Tidal Carbon Dioxide (ETCO2) via nasal cannula (ETCO2-NC) and routinely measured physiologic and participant reported parameters in extubated participants who have received a continuous flow left ventricular assist device (CF-LVAD), and to determine if the addition of ETCO2-NC monitoring to usual care is associated with decreased incidence and severity of respiratory issues.

A convenience sample of 60 participants either scheduled for mechanical circulatory support device (MCSD) implant or who have been readmitted to an intensive care unit (ICU) with a CF-LVAD will be recruited and randomized to usual care or usual care plus ETCO2-NC throughout their stay in the ICU.

Investigators seek to examine the relationship between ETCO2-NC with traditional physiologic measures, clinical assessments, and participant reported symptoms in persons with a CF-LVAD. Additionally, this study intends to compare the respiratory outcomes of extubated persons with a CF-LVAD randomized to usual care to those receiving usual care plus ETCO2- NC.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for mechanical circulatory support device (MCSD) implant or have been readmitted to an intensive care unit (ICU) with a continuous flow left ventricular assist device (CF-LVAD)
* New York Heart Association (NYHA) functional class III to IV
* Ability to read, write, and speak English

Exclusion Criteria:

* Requiring mechanical ventilation during the active phase of the trial
Prevalence of Non-Carious Cervical Lesions in Patient With Gingival Recession and Associated Risk Factors

The study aims at determining the prevalence of non carious cervical lesions in patients with gingival recession in Egyptian population and associated risk factors including gingival biotype, keratinized tissue width, gingival index, plaque index, occlusal wear grade, sensitivity. and a questionnaire will be filled by patients with another risk factors including age, gender, toothbrush frequency and type, bruxism, gastric reflux, soft drinks, alcohol and citrus fruits. Also OHIP-14 will be answered in a questionnaire form by patients.

Dental patients will be recruited in a consecutive manner from diagnostic centre at Cairo University Dentistry faculty. Patients with NCCL will be selected for questionnaires and clinical examination. Thorough oral examination will be done, the full aim of the study will be explained to the patient, and patient acceptance is a must. The questionnaire will be done with face to face interview with the patient will include associated risk factors including gingival biotype, keratinized tissue width, gingival index, plaque index, occlusal wear grade, sensitivity. and a questionnaire will be filled by patients with another risk factors including age, gender, toothbrush frequency and type, bruxism, gastric reflux, soft drinks, alcohol and citrus fruits. Also OHIP-14 will be answered in a questionnaire form by patients including: functional limitations, physical pain, psychological discomfort, physical disability, psychological disability, social disability, handicap. then clinical examination will be done for NCCL using mirror, probe, light of the unit, air tip.

Eligibility Criteria:
Inclusion Criteria:

* adult patients with NCCL and gingival recession whose age is above 15 years old
* patients consulting in dental Diagnostic Centre, faculty of dentistry, Cairo University
* patients provide informed consent

Exclusion Criteria:

* patients having problem in mouth opening or undergoing intermaxillary fixation where oral examination is not possible
* patients diagnosed with psychiatric problems
Reducing Unmet Mental Health Need of African-American Children

The purpose of this study is to compare two versions of school-based mental health screening to improve the receipt of mental health services among elementary school students.

School-based mental health (SBMH) is a critical pathway for accessing mental health services for African American/Black (AAB) youth who experience the greatest gap in unmet mental health need in comparison to their White, non-Hispanic peers, but are twice as likely to access mental health services in schools as outpatient or specialty clinics. Unfortunately, AAB children's access to SBMH is dependent on school intervention team decision making, which often involves consideration of factors other than student need. School personnel on intervention teams disproportionately attribute AAB youth's behavior problems as disciplinary issues rather than mental health needs, reducing the likelihood AAB students receive SBMH services. Consistent with the empirical literature, patient families and stakeholders recommend universal mental health screening to better identify AAB children with mental health needs and enhancements to address unintentional racial biases and poor mental health literacy of school personnel making intervention referral decisions. Thus, we will evaluate the comparative effectiveness of the SBMH delivery system enhanced with screening to a package of enhancements implemented with screening in SBMH to increase the likelihood AAB students receive the services they critically need. The enhancements include three components: (1) unintentional racial bias training and (2) mental health literacy training for voluntary school team members, and (3) a refinement to school teams' data-based decision-making process in which they also voluntarily review screening, mental referral/receipt, and discipline data disaggregated by race/ethnicity to identify and problem solve system-level inequities. We will test both whether and how (i.e., mediational analyses of causal pathway including knowledge, attitudinal, and behavioral observation of unintentional bias and mental health literacy) these enhancements impact student-level intervention and disciplinary referral outcomes. In a mixed method process evaluation and comparative analysis, we will also examine school-level contextual factors (i.e., team member tenure, pre-intervention discipline rates, racial/ethnic and socioeconomic composition of student body, and perceptions of intervention impact and acceptability) and implementation outcomes (i.e., fidelity, dosage/exposure, and reach).

Eligibility Criteria:
Inclusion Criteria:

* Students at study school
* School intervention teams at study school

Exclusion Criteria:

* Students who are wards of the state or any other institution, agency, or entity
Efficacy and Safety of Desferal Versus Osveral in Transfusional Iron Overload

Thalassemic patients often suffer from iron overload due to frequent blood transfusion. Oral iron chelators reduce iron overload in transfusion dependent patients. The aim of this study is to compare the efficacy and safety of osveral and desferal in transfusional iron overload patients with β-Thalassemia and intermediate Thalassemia in Bandarabbas.

This is a double blinded randomized controlled trial on Efficacy and safety of Osveral and Desferal in thalassemic patients.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed intermedia or major thalassemia
* More then 2 years old
* Serum Ferritin level \> 1000
* Normal Creatinine and Complete Blood Count (CBC)

Exclusion Criteria:

* HCV, HBV or HIV positive patients
Pulsed Dye Laser and Intense Pulsed Light (IPL) for the Treatment of Telangiectasia and Skin Redness

The purpose of the study is to compare efficacy and adverse effects of pulsed dye laser and intense pulsed light in patients with skin telangiectasia and redness.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Skin types I, II, III
* No previous laser or IPL treatment for the condition

Exclusion Criteria:

* Younger than 18 years old
* Skin types IV, V, or VI
* Pregnant or lactating women
* Previous laser or IPL treatment for the condition
* Recent exposure to sun or sun-beds
* Treatment with oral retinoid within 6 months
* Tendency to produce hypertrophic scars or keloids
Community-Associated Uropathogen Antimicrobial Resistance Among Emergency Department Patients With Acute Pyelonephritis

Pyelonephritis is a serious infection that manifests with fever, back pain, nausea, and vomiting. In the U.S., it is estimated that there are 20 cases of pyelonephritis per 10,000 annually, with the highest incidence in young women. Escherichia coli (E. coli) causes over 80% of these infections. Over the last two decades, E. coli resistance has emerged to commonly prescribed antimicrobials, such as ampicillin and trimethoprim-sulfamethoxazole (TMP/SMX). Most recently, resistance to fluoroquinolones and strains producing extended-spectrum beta-lactamases (ESBL) have been observed. In order to better understand the evolution and current state of antibiotic resistance among E. coli urinary tract isolates so as to better inform treatment decisions, the investigators propose to conduct an investigation to: a) determine the prevalence of antimicrobial resistance among E. coli causing acute pyelonephritis in various patient groups, and specifically healthy community-dwellers with uncomplicated infections, b) determine the specific prevalence of fluoroquinolone-resistance and ESBL-producing E. coli, and c) determine potential risk factors for fluoroquinolone and ESBL-producing E. coli infections.


Eligibility Criteria:
Inclusion Criteria:

* patients \> 18 years of age with flank pain and/or costovertebral angle tenderness
* documented temperature in the emergency department of ≥38°C/100.4°F by any method of measurement,
* documented temperature in the emergency department of ≥38°C/100.4°F by any method of measurement,

Exclusion Criteria:

* complicated pyelonephritis
Treatment Effects of Herbst Appliance in Skeletal Class II Cases During Prepubertal and Postpubertal Periods

The study was directed to compare the treatment outcomes of subjects with Class II malocclusion who were treated with Herbst appliance before and after puberty.

Thirty-six Class II patients were randomly selected and divided into two groups based on their stage of skeletal maturation: pre-pubertal group (18 patients, mean age 9.15± 1.5 years) and post-pubertal group (18 patients, mean age 16.3 ± 1.0 years). All patients were treated with metallic splint supported Herbst IV appliance.

Pretreatment and post-Herbst IV treatment cone beam CT(CBCT) scans were obtained for both groups. Dentoskeletal and TMJ measurements made on the CBCT scans were analysed.

Eligibility Criteria:
Inclusion Criteria:

1. Skeletal Class II malocclusion with retrognathic mandible (ANB \>5°, SNB\<76°)
2. Normal growth pattern (SN/MP angle was in 25°- 35° range)
3. Unilateral or bilateral Class II molar relationship greater than or equal to one-half a cusp width.
4. Minimal or no crowding in the mandibular arch (0-5mm).
5. Average inclination or slight retroclination of the lower incisor.
6. An overjet greater than 5 mm.

Exclusion Criteria:

1. Skletal Class I
2. Craniofacial syndrome.
The Lung Microbiome and Endobronchial Valve Treatment

Lung emphysema is often associated with chronic obstructive pulmonary disease (COPD) and without any cure. Dyspnea is the main, debilitating symptom and is relieved by inhaled bronchodilators and rehabilitation. However, a substantial number of patients continue to suffer from dyspnea and among these, many patients have severely hyperinflated lungs due to predominant emphysema. For selected patients, lung transplantation or lung volume reduction by surgical removal (LVRS) of the most emphysematous parts of the lung can improve symptoms and survival. However, LVRS is related to complications and not all patients are suitable for surgery. An alternative to LVRS is bronchial lung volume reduction with endobronchial valves (EBV). One-way valves are inserted in the bronchial system using a bronchoscope and it has emerged as a valid treatment option with similar effects as LVRS with reduction of hyperinflation and increasing pulmonary function, quality of life, and exercise capacity.

The normal lung is colonized with several types of bacteria, and together this is called the microbiome. Some bacteria are potentially beneficial, while others are potentially harmful. After the insertion EBV, some patients develop chronic infections. The hypothesis is that the microbiome can affect the risk of this chronic infection, and therefore the objective of this study is to access the microbiome during the insertion of the EBV, and afterwards observe which patients develop chronic infection and if these patients are harbouring specific types of bacteria.

The objective of this study is primarily to investigate the significance of the lung microbiome on the outcome and morbidity after EBV treatment. Second, to investigate the evolution of the lung microbiome in patients later requiring valve removal or clean-up.

Before the insertion of the EBV, but during the procedure, the patient will undergo a bronchoalveolar lavage (BAL). BAL fluid will undergo bacterial profiling through S16-ribosomal analysis and ordinary bacterial culturing. Number of infections and need for clean-up or valve removal will be registered during the following 24 months, where the patient follows the ordinary follow-up programme. As a secondary part of the study, during the potential clean-up or valve removal, the removed material will again undergo S16-ribosomal analysis and bacterial culturing to investigate shift in microbiome.

Eligibility Criteria:
Inclusion Criteria:

* COPD patients with emphysema selected for EBV treatment by multidiciplinary team, independent of this study.
* Written informed consent

Exclusion Criteria:

- Intake of oral antibiotics within 1 month before the procedure. Patients receiving preventive long-term treatment with antibiotics can be included.