cyrilzakka/clinical-trials huggingface dataset:
Effect of Hippotherapy and Schroth Exercise on Pulmonary Function and Aerobic Capacity in Idiopathic Scoliosis

BACKGROUND: Idiopathic scoliosis has been identified as a common spinal malalignment that negatively impacts the respiratory system and physical conditioning in adolescents. Hippotherapy is an equestrian intervention that optimizes physical performance and mobility in a bunch of contexts; however, its influence on pulmonary function remains unclear.

AIM: This research aimed to analyze the impact of ten weeks of hippotherapy combined with Schroth exercises on ventilatory function and aerobic capacity in AIS.

DESIGN: Randomized Controlled Trial SETTING: Outpatients attend a single center that includes a rehabilitation room and recreational riding center.

POPULATION: Forty-five patients were arbitrarily recruited to the experimental (N= 22) and control group (N=23).

METHODS: Patients in the experimental group received 30 minutes of walking and sitting trot training, 15 sessions split into 2 phases over ten weeks. The two groups attended a 60-minute session of Schroth's intervention, 3 times/ week for 10 weeks. Two-way ANOVA for between-group comparisons and independent t-test for within-group comparisons were used in the statistical analysis.

A total of 45 patients (13 males and 32 females) participated in the current study. The participants were assigned to one of two groups in a random manner: an experimental group who received hippotherapy combined with Schroth Exercise and the control group who received only schorth exercise. (FVC, FEV1, FEV1/FVC, MVV, and 6MWT) were measured before and after 10 weeks intervention

Eligibility Criteria:
Inclusion Criteria:

* all types of curves,
* curves between 10 and 20 degrees (29),
* Risser grade 0 to 5
* the availability to be engaged in once a week visit

Exclusion Criteria:

Adolescents with:

* obstructive pulmonary diseases
* associated neuromuscular diseases
* recent infectious episodes in the previous two months
* history of cardiovascular or psychological disorders
* any significant history of riding horses
Efficacy of Ranibizumab in Combination With Photodynamic Therapy for Wet Age-Related Macular Degeneration

The purpose of the investigators study is to look at the visual outcomes of Ranibizumab injections in combination with photodynamic therapy for the treatment of neovascular age-related macular degeneration.

The main cause of severe vision loss in patients with age-related macular degeneration (AMD) is the development of choroidal neovascularization (CNV). This debilitating form of AMD affects the macula lutea, the central part of the retina, which is responsible for high resolution visual acuity. Characteristic findings in neovascular AMD include the development of new, abnormal blood vessels in the choroid layer beneath the macula otherwise known as CNV.

Current treatment options for this condition have included include laser therapy, photodynamic therapy (PDT), and intraocular injections (different types of anti-vascular endothelial growth factors) alone or in combination. While current treatments were demonstrated to slow the progression of vision loss, neither therapy was shown to significantly improve visual acuity.

Given their different modes of action, it is believed that combination therapy of Ranibizumab with PDT may lead to better visual outcomes and may result in an improved effect in treating AMD and therefore may help decrease the need for monthly Ranibizumab injections. After the first injection, regardless of which group the patient has been assigned to, they will receive Ranibizumab injections at 4 week intervals if clinically indicated. The purpose of the this study is to evaluate the visual outcomes of intraocular Ranibizumab injections in combination with photodynamic therapy with verteporfin for the treatment of neovascular AMD.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with any subtype of primary subfoveal or juxtafoveal choroidal neovascularization
* must be 50 years of age or older
* have a lesion whose total size is no more than 5400micrometres in greatest linear dimension in the study eye
* CNV that is more than 50% obscured by blood
* have best corrected visual acuity of 20/50-20/320 (Snellen equivalent)
* have been assessed with the use of early treatment diabetic retinopathy study charts

Exclusion Criteria:

* previous treatment (including verteporfin therapy) that could compromise an assessment of the study treatment
* any permanent structural damage to the central fovea
Oral Health-Related Quality of Life of Early Childhood Caries Using Silver Diamine Fluoride Versus Drill and Fill Technique

The clinical trial aims to compare children's oral health-related quality of life (OHrQL) following caries arrest technique using SDF versus conventional drill and fill in the children with ECC

Early childhood caries (ECC) has been an increasing issue in many countries and has become a significant health problem, especially in socially disadvantaged populations. ECC is a specific form of caries that occurs in children with primary teeth. ECC is characterized as "the early onset of caries in young children with often fast progression which can finally result in complete destruction of the primary dentition".

Management of cavitated carious lesions in primary teeth in very young children is time-consuming due to their lack of cooperation, so one of the alternative procedures could be performed with silver diamine fluoride (SDF), to its effectiveness in arresting the activity of carious lesions (cavitated and non-cavitated). It is easy to apply even outside dental offices, and relatively inexpensive solutions can be used particularly when compared to restorative intervention.

Eligibility Criteria:
Inclusion Criteria:

* Children Aged 3 to 5 years, in good general health and medically within normal.
* The parents provided written informed consent.
* Carious vital primary molars with reversible pulpitis.
* Restorable teeth.
* Normal Radiographic findings.

Exclusion Criteria:

* Unable to attend follow-up visits.
* Refusal of participation.
* Previously accessed teeth.
Evaluation of Right To Play's Positive Child and Youth Development Program in Middle Schools in Hyderabad, Pakistan

This is a RCT conducted with 1752 children in 40 public middle schools in Hyderabad Pakistan with the goal of evaluating the effectiveness of the international non-governmental organisation Right To Play's Positive Child and Youth Development program on reducing peer violence perpetration and victimisation and child depression in a two arm trial where this intervention is compared to a no intervention arm.

Peer violence is an important violence exposure for young adolescents and has been linked to later perpetration or experience of violence in intimate relationships. It is an obstacle to learning and may impact school students' mental health. Prevention of peer violence requires an intervention that empowers youth and teaches them empathy and stronger social skills. The non-governmental organisation Right To Play operates in 18 countries and has a flagship programme that is used in all countries that has never been subject to most rigorous evaluation. It is a multi-faceted programme that has at its heart an intervention that is delivered throughout the school year in two 35 minute sessions games following activities from the manual Red Ball Child Play that focus on 4 areas of youth development: physical, cognitive, social, and emotional components. These structural activities are designed to improve critical thinking, confidence and resilience. They are complimented by a range of additional activities including junior leader training for selected promising young leaders, week long summary camps, sports days and activities to engage parents and members of the community. The main intervention is delivered by coaches employed by Right To Play and given a 3 week training initially, with subsequent regular refresher engagement. They are supported by junior leaders in the games after junior leader training. Training to teachers on the intervention is also provided.

A two-arm, cluster randomised controlled trial based in middle schools in Hyderabad, Sindh province, Pakistan is evaluating this intervention. It is being conducted in 40 schools, half are boys schools (20) and half (20) girls'. Twenty of the schools have been randomised to the intervention arm and twenty to the control (delayed intervention) arm. The outcomes will be addressed using quantitative methods with data collected from students in Grade 6 at the start of the trial. These measures will be conducted pre-intervention and 12, and 24 month follow up periods.

Eligibility Criteria:
Inclusion Criteria:

* Schools: single sex, public middle schools in Hyderabad; willing to participate and commit time during the school day, twice a week, to the intervention sessions; having an outside playground or indoor space in which games could be played, and 35 or more students in the grade-6 class

School student participants: enrolled in grade 6 in one of the study schools; informed consent from parent and child; able to read the national language Urdu or provincial language Sindhi

Exclusion Criteria:

* None
MRX-I Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection

The purpose of this study is to determine whether MRX-I is as safe and effective as Linezolid in the treatment of adult patients with acute bacterial skin and skin structure infections


Eligibility Criteria:
Inclusion Criteria:

* Patients with systemic signs of infection diagnosed with acute bacterial skin and skin structure infection (ABSSSI)
* Diagnosed with Cellulitis/ erysipelas, major cutaneous abscess, or wound infections

Exclusion Criteria:

* Uncomplicated skin infections
* Severe sepsis or septic shock
* ABSSSI solely due to gram-negative pathogens
* Prior systemic antibiotics within 96 hours of randomization
Genetic and Phenotypic Characteristics of Mitral Valve Prolapse

Phenotypic characterisation of MVP by echocardiography in families. Identification of genes involved in MVP.

After clinical identification of patients with MVP, doctors organize 1st degree relative familial screening. A comprehensive echocardiography was carried out along with clinical examination. All echo data were stored for off-line analysis by a sonographer in our Core-lab. Blood was sample at the time of echocardiography in adult patients for DNA analyses. Follow-up for mitral valve changes will be performed after 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients of any age
* with typical mitral valve prolapse
* relatives examined during familial screening

Exclusion Criteria:

* Refusal of the patient
Piperacillin-Tazobactam Continuous Versus Intermittent Infusion for Pseudomonas Aeruginosa

The main objective is to verify that the administration of piperacillin / tazobactam administered by continuous infusion to treat complicated infections or with known or suspected nosocomial isolation of Pseudomonas aeruginosa is superior in efficacy to a 30% higher dose administered in conventional short infusion.

The secondary objectives were compared between the following variables:

* Microbiological response at 3 days of starting treatment
* Time to microbiological cure
* Clinical response at 3 days of starting treatment
* Time to achieve defervescence
* To examine the relationship between pharmacokinetic variables and parameters of efficacy and safety
* To test the hypothesis that continuous infusion maintains adequate plasma drug levels compared with levels achieved with intermittent administration.
* Cost-effectiveness analysis
* Occurrence of adverse effects

To this end, we designed a multicenter, randomized, controlled, double blind, comparing both forms of administration in patients with complicated or nosocomial infection with or without isolation of Pseudomonas aeruginosa.

Patients who are candidates for inclusion are classified according to APACHE II and to have or not isolation of Pseudomonas aeruginosa. Subsequently be randomized to receive piperacillin-tazobactam by continuous infusion or short. Primary endpoint was measured as the ultimate effectiveness of treatment and other variables such as high efficiency, safety, pharmacokinetic and pharmacoeconomic.


Eligibility Criteria:
Inclusion Criteria:

* Complicated or Nosocomial Pseudomonas Aeruginosa Infection or Suspected Infection
* \> 18 years and \> 40 kg
* Negative pregnancy test for women within fertile period
* Informed consent signature

Exclusion Criteria:

* Life expectancy \< 72 hr
* Central Nervous System (CNS) infection
* Ventilator-associated pneumonia
* Severe Neutropenia (\<500 cells/ml)
* Acinetobacter baumannii or extended spectrum beta lactamase (ESBL) suspected infection
* Cystic fibrosis
* Shock
* Creatinine clearance \< 20 ml/min
* Dialysis or hemoperfusion
A Study to Optimize Care for Lung Cancer Patients Undergoing Video-Assisted Thoracoscopic Surgery (VATS)

This is a research study for participants who have been diagnosed with lung cancer and are receiving VATS (Video Assisted Thoracoscopic Surgery) lobectomy or segmentectomy. The overall objective of this study is to develop a database to collect data on participants who are undergoing VATS lobectomy or segmentectomy for lung cancer.

This database will be used as for quality improvement purposes. Furthermore, the database will help in collecting data in an organized fashion, which will help the investigators learn more about the details of the workup performed prior to the surgery, during the surgery, peri-operative management and early follow-up. The investigators hope that this database will help to determine a common guideline to perform VATS lobectomy or segmentectomy. By creating a common guideline for future treatment of VATS patients, the investigators predict the efficiency of the process will increase significantly without decreasing, and perhaps even improving, the quality of the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects
* Age ≥ 18 years
* Underwent a VATS lobectomy or segmentectomy procedure for lung cancer -- Note: patients with other malignancies are eligible if they have a primary cancer of the lung as defined above

Exclusion Criteria:

* Subjects undergoing thoracotomy lobectomy or segmentectomy for lung cancer
* Subjects undergoing surgical procedures other than VATS lobectomy or segmentectomy for lung cancer
A Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Dialysis Patients

This 6 month long study will assess an investigational medication for patients on dialysis with secondary hyperparathyroidism. The study will look at the effects on parathyroid hormone, calcium and phosphorus levels.


Eligibility Criteria:
* Patients must be receiving hemodialysis; \* Have elevated parathyroid hormone levels; \* Not be pregnant or nursing; and \* Not have had a heart attack in the last 3 months.
Effect of Double Tourniquet Technique on Ultrasonographic View of Forearm Veins

Vein compressibility will be assessed after light pressure applied with the ultrasound probe. Vein compressibility will be graded as 3 (100% compressed), 2 (50-100 compressed), and 1 (less than 50% compressed). After baseline measurements were taken, a proximal tourniquet will be applied to mid-arm. Repeated measurements of depth, width, and compressibility will be taken one minute after the tourniquet was applied. Same measurements will be repeated again with second tourniquet applied 1 cm distal to the first tournique.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers aged 18-60 years will participate in the study

Exclusion Criteria:

* patients with dialysis shunts, previous mastectomy on the examined side, fracture , skin lesion , burn or edema on the examined side
Acupuncture Treatment for Patients Who Develop Arrhythmias in the Post-Operative Cardio-Thoracic Setting

A feasibility study on the provision of acupuncture treatment in the hospital to 20 patients who have undergone open heart surgery procedures. The acupuncture treatments may begin as early as postoperative Day 2.

Primary Aim • Evaluate the feasibility of providing acupuncture in the hospital setting for 20 patients undergoing open heart surgery and subsequently develop arrhythmias.

Secondary Aims

• Evaluate the short-term effect of acupuncture including the effects on patient's arrhythmias, stress, anxiety, and pain measured by Electrocardiogram monitoring and Electrocardiography, VAS scores, and WIWI questionnaire for the patient.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who have undergone CABG and/or cardiac valve operations.
2. Patients developing postoperative atrial fibrillation, and documented by ECG prior to acupuncture intervention, and treated with the common anti arrhythmic treatment of the department.
3. Patients moving to the step-down unit on postoperative day 2 or later.
4. Ability to provide informed consent.
5. Ability to speak English and complete all aspects of this trial.
6. At least 18 years of age.

Exclusion Criteria:

1. Patients with any other cardiac or non-cardiac concomitant procedures.
2. Patients with suspected sternal wound infection and/or with prolonged sternal wound dressing and wound- Vac-system application or open chest wound.
3. Patients with abnormal postoperative track staying in the intensive care unit for any clinical reason or hemodynamic compromise.
4. Patients with platelet count \<50,000
5. Patients in a severe immunocompromised state.
6. Pregnant women. All patients who meet the criteria will have their medical records reviewed to ensure they are not pregnant.
A Study in Healthy Subjects to Investigate Pharmacokinetics of AZD5423 When Administered in Different Ways

The purpose of this study is to look at drug levels of AZD5423 in blood when the drug is administered in different ways - orally, intravenously or inhaled (with four different devices), to healthy subjects

A Phase I, Single Centre, Open, Partly Randomised, Crossover Study in Healthy Subjects to Evaluate AZD5423 Absolute Pulmonary Bioavailability when Administered Inhaled via a New Dry Powder Inhaler, Turbuhaler, Spira nebulizer and I-neb AAD system

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or women of non-childbearing potential aged 18-45 years inclusive with suitable veins for cannulation or repeated vein puncture
* Have a body mass index (BMI) between 19 and 30 kg/m2 (inclusive and rounding allowed) and weight between 50 and 100 kg (inclusive)
* Be able to inhale from the inhaler devices used in the study according to given instructions as well as be able to perform spirometry

Exclusion Criteria:

* History of any clinically significant disease or disorder
* Current smokers
* Any clinically relevant abnormal findings
Nicotinamide Riboside in SARS-CoV-2 (COVID-19) Patients for Renal Protection

An interventional clinical trial using oral nicotinamide riboside (NR) in hospitalized patients with COVID-19 infection and acute kidney injury to determine the effect of NR on whole blood nicotinamide adenine dinucleotide (NAD+) levels and to evaluate safety of the use of NR.

The study team chose a treatment protocol with NR as a treatment for patients who will be admitted with COVID-19 related illness and develop AKI after admission. Treatment duration will be for 10 days and the primary study endpoint will be the change in whole blood NAD+ from baseline to end of treatment in NR group vs placebo group. The study team will evaluate whole blood NAD+ levels as a marker of efficacy and biological effect of NR.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form from a participant or legally authorized representative (LAR);
2. Male or female, \>18 years old;
3. Hospitalized participants with a laboratory diagnosis of COVID-19 infection
4. Evidence of persistent AKI as defined by the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines (Table 3);
5. Willing to adhere to the study intervention regimen;

Exclusion Criteria:

1. Hypersensitivity to nicotinamide riboside (NR);
2. Pregnant or lactating women confirmed with positive laboratory pregnancy tests as per local requirements;
3. eGFR \<15 mL/min/1.73 m2 as per the Chronic Kidney Disease Epidemiology Collaboration equation at admission lab;
4. Maintenance renal replacement therapy or initiation of renal replacement therapy before randomization
5. Currently on NR or nicotinamide or vitamin B3 (niacin) supplementation (multivitamins are allowed);
6. Concomitant cirrhosis of liver or acute liver failure;
7. Any medical history or condition that might, in the opinion of the attending physician, put the participant at significant risk if he/she were to participate in the trial;
8. Individuals with kidney transplant;
9. Individuals with blood platelet count \<100,000/microL
Your COACH Next Door Study

Your COACH Next Door (YCND) is a lifestyle intervention connecting children with overweight and their families with a coach close to home.

This study goal is to examine the effects of YCND for children and their families, (on their health, quality of life), and a process evaluation (process of the lifestyle intervention, and satisfaction for children, families and healthcare givers)

Childhood overweight and obesity in an increasing problem worldwide. Among other, childhood obesity is associated with type 2 diabetes, cardiovascular disease, NAFLD and decreased quality of life. In 2016 the lifestyle intervention Your COACH Next Door (YCND) was founded in Maastricht, The Netherlands, as a tailored, network approach for children with overweight and obesity. YCND is following the example of COACH, the tailored lifestyleintervention for childhood obesity of the expertise centre of the MUMC+ hospital.

YCND is connecting children with overweight and their families with a coach close to home.

This study goal is to examine the effects of YCND for children and their families, (on their health, quality of life), and a process evaluation (process of the lifestyle intervention, and satisfaction for children, families and healthcare givers)

Eligibility Criteria:
Inclusion Criteria:

* Participant of the YCND lifestyle intervention.
* Having overweight or obesity
* Younger than 18 years at inclusion

Exclusion Criteria:

* No exclusion criteria
The Alaska Oculocardiac Reflex Study

Observation study monitoring vital signs and anesthetic variables particularly heart rate during prospective, ocular manipulation and specifically uniform tension on extra ocular muscles during strabismus surgery.

\*IRB approval from 1992 covered in letter from then IRB chair Dr. Judith Whitcomb, Anchorage, Alaska (letter 10/2020).\*

Patients with ocular manipulation including those scheduled for strabismus surgery will have peri-operative variables monitored before, during and after uniform traction on extra ocular muscles (EOM). The oculocardiac reflex (OCR) will be elicited by quantified (200 gram, 10-second, square-wave) traction on Jameson muscle hook under insertion of an extra ocular muscle (EOM, rectus). Stable pre-tension heart rate, and greatest change heart rate will be recorded. Additional variables to be recorded: birthdate, gender, race, weight, iris color, pre-operative neurodevelopmental conditions, pre-operative medications, induction medications, expired carbon dioxide (CO2) levels, exhaled gas concentrations, anticholinergic medications, opioids, muscle relaxants, type of airway and the number of EOM operated.

Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled for ocular manipulation and tension on extra ocular muscles and strabismus surgery

Exclusion Criteria:

* anophthalmia