cyrilzakka/clinical-trials huggingface dataset:
Osseodensification by Densah Burs Versus Osteotome

implant placement in the posterior maxilla is problematic, not only due to inferior properties of bone but also due to loss of vertical bone height which happens after extraction of posterior teeth. when the required additional height is few millimeters, indirect transcresta sinus lifting procedures are recommended.

This study compares sinus lifting using the conventional osteotome versus the osseodensification with densah burs.

a total of 12 patients with missing maxillary premolars or molars and with limited vertical bone height below the maxillary sinus floor will receive implants either with osteotome or with Densah burs transcrestal sinus lifting to compare clinically and radiographically transcrestal sinus lifting with Densah burs and osteotome with simultaneous implant placement

Eligibility Criteria:
Inclusion Criteria:

* Patient with missing maxillary premolas and molars
* Vertical bone height of 5-8 mm
* Non smokers
* Good oral hygiene

Exclusion Criteria:

* Bad oral hygiene
* maxillary sinusitis
* Presence of infection or periapical lesions in adjacent teeth
* Bruxism or clenching
* Alcoholism
* Medically compromised patients with a condition that affect the procedure
* Multiple sinus septa
HIIT Following Breast Cancer Chemotherapy

Chemotherapy is an effective breast cancer treatment, which helped to increase the 5-year survival rate to approximately 95%. However, breast cancer survivors have a higher risk of cardiovascular disease (CVD) due to chemotherapy than adults without cancer. Cardiovascular rehabilitation can be an effective strategy to decrease the incidence of CVD and its risk factors in this population. The proposed study may help to examine the effect and durability of a novel high-intensity interval training compared to moderate-intensity continuous training on cardiovascular rehabilitation in breast cancer survivors.


Eligibility Criteria:
Inclusion Criteria:

* female patients based on biological sex
* 18 to 85 years of age
* diagnosis of primary, invasive, non-metastatic, stages I-III breast cancer
* completed chemotherapy for breast cancer (anthracycline, alkylating agent and/or taxane) more than 6 months but less than 18 months prior to study enrollment. Adjuvant endocrine therapy for breast cancer (e.g., ovarian suppression, SERMs, SERDs, AIs), CDK4/6 inhibitors, PARP inhibitors, HER2 targeted agents, immunotherapy, and bisphosphonates are allowed within 6 months of study enrollment and during study participation
* absence of contraindications to exercise or to participate in study
* study clinician approval

Exclusion Criteria:

* do not meet inclusion criteria
* scheduled to receive surgery or radiation therapy during the intervention period
* any relevant cardiovascular diseases (stroke, heart failure, myocardial ischemia during maximal graded exercise test, myocardial infarction, angina pectoris, coronary artery bypass surgery or angioplasty or coronary stent)
* lymphedema stage ≥2 prior to study enrollment
* are pregnant
* current participation in other experimental interventions that may confound interpretation of study findings (e.g., dietary intervention for weight loss)
A Study Investigating the Utilization, Effectiveness and Quality of Life in Clinical Practice in Germany for Participants With Relapsing-remitting Multiple Sclerosis Treated With Ozanimod (Zeposia®)

The purpose of this study is to collect real-world data and to gain insights about long-term usage of ozanimod (Zeposia ®), its effect on well-defined outcome parameters comprising participant-relevant outcomes, as well as quality of life, effectiveness, and incidence of adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of relapsing-remitting multiple sclerosis (RRMS)
* The decision upon treatment with ozanimod must have been made before enrollment and independently of this non-interventional observational study
* All data on ozanimod treatment are collected prospectively. The retrospective documentation of ozanimod therapy and enrollment of participants that are already on ozanimod therapy is not allowed

Exclusion Criteria:

* Special warnings, precautions and contraindications specified in the current version of the Summary of Product Characteristics (SmPC)
* Hypersensitivity to the active substance(s) or to any of the excipients of ozanimod as specified in the prescribing information must not be enrolled
* Participation in any other clinical studies

Other protocol-defined inclusion/exclusion criteria apply
Efficacy and Safety Study of Fluvastatin and Ezetimibe Combined Versus Fluvastatin Alone

The objective of this study is to assess the effect of the combination treatment on C-reactive protein and inflammatory markers as well as the safety and tolerability in a Spanish population


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-75 Primary hypercholesterolemia Signed informed consent

Exclusion Criteria:

* Patients involved in clinical trials 3 months prior to inclusion Patients treated with drugs specified in protocol Fertile women not using contraceptive methods

Other protocol defined in and exclusion criteria may apply
A Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-386 in Healthy Male Volunteers

a study to investigate the pharmacokinetic characteristics and safety/tolerability according to formulations of CKD-386 in healthy male volunteers

A sequence-randomized, open-label, 3-way crossover, single oral dose clinical trial to investigate the pharmacokinetic characteristics and safety/tolerability according to formulations of CKD-386 in healthy male volunteers

Eligibility Criteria:
Inclusion Criteria:

1. Healthy volunteers aged between ≥20 and ≤45 years old
2. Weight ≥ 50 kg, with calculated body mass index(BMI) of ≥ 18.5 and ≤ 27.0 kg/m2
3. Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings
4. Those who are judged to be eligible for clinical trials based on laboratory and ECG results during screening tests
5. Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial

Exclusion Criteria:

1. History of presence of hepatobiliary, renal, cardiovascular, endocrine, respiratory, gastrointestinal, hematological, neurologic, psychiatric or musculoskeletal disorders affecting absorption, distribution, metabolism and excretion of the drug
2. Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
3. Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests
The Effect of Delayed Cord Clamping and Milking on the Amount of Stem Cells In Preterm

Stem cell therapies have been promising therapies in neonatal morbidities such as bronchopulmonary dysplasia, intraventricular hemorrhage and hypoxic ischemic encephalopathy. Although researchers showed those effects by several mechanisms including paracrine effect, regenerative and restorative effects, there is no obvious recommendations for the type of stem cells, dosage or the route of administration the cells. The usage of exogenous stem cells can be difficult due to technical issues in preterm infants.

In the presence of these data, the amount of endogenous stem cells passing through the cord to the infant may show differences in terms of delayed cord clamping and milking. Therefore the aim of this prospective randomized study is to determine the quantity of the stem cells according to delayed cord clamping or cord milking. We also aimed to evaluate the association between the number of stem cells and neonatal morbidities.


Eligibility Criteria:
Inclusion Criteria:

* Infants born under 32 weeks of gestation
* Accepted to participate with informed consent
* History of healthy pregnancy
* Infants born and will be followed up at the study hospital

Exclusion Criteria:

* Congenital abnormalities
* Chromosomal abnormalities
* Declined to participate
Investigation of the Effect of Manual Therapy and Pelvic Floor Exercises on Pelvic Floor Muscles

The goal of this clinical trial is to Investigation of the effect of manual therapy and pelvic floor exercises on pelvic floor muscle in women with constipation. The main question\[s\] it aims to answer are:

* In addition to pelvic floor exercises, manual therapy applied to the pelvic floor muscles has no impact on constipation.
* In addition to pelvic floor exercises, manual therapy applied to the pelvic floor muscles has an impact on constipation.

Participants will apply pelvic floor exercises and manual therapy techniques. If there is a comparison group: Researchers will compare \[insert groups\] to see if \[insert effects\].

* Female participants aged 18-55 years with constipation complaints will be recruited through social media and hospital outpatient clinics, and those who volunteer to participate will be enrolled in the study.
* Participants will be assessed as group 1 (pelvic floor exercises), group 2 (pelvic floor exercises + manual therapy techniques). Group 1 will receive diaphragmatic breathing training and then pelvic floor exercises to strengthen the pelvic floor.
* Group 2 will receive manual therapy methods consisting of Momentum Minus Mobilisation, Sphincter Opening, Colon Massage, Global Fascial Manipulation, Trigger Point and Myofascial Release in addition to Diaphragmatic Breathing Training and Pelvic Floor Exercises.
* Participants will receive exercise training 5 days a week for 6 weeks. Manual therapy methods will be used 2 days a week for the first 2 weeks and then 1 day a week. Initial assessment of participants and manual therapy applications will be done face to face. The exercises will be continued using the online telerehabilitation method.
* Both groups will be given nutritional advice, such as drinking plenty of water, eating fibre-rich foods and preferring foods that aid digestion. Participants will be advised to take their time every day, in the morning, at the same time, without rushing to defecate, preferring an squat toilet, which increases intra-abdominal pressure, half an hour after meals, but not for more than five minutes.If a European toilet is used, toilet training will be given about leaving a 15-18 cm long ridge under the feet.
* Both groups will be given assessment tests before and at the end of the trial and the results will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Constipation in the last 6 months
* Being able to use smartphones and social media (whatsapp and instagram)
* Not having a health problem that prevents exercise
* Able to communicate
* Literate

Exclusion Criteria:

* Not had constipation in the last 6 months
* Pregnancy or recent pregnancy
* had surgery
* having a tumour
* Having vertigo Taking medication (use of bowel-regulating drugs)
* Previous physiotherapy for constipation problems
* Inflammatory bowel disease
Complementary Feeding Project in Ethiopia

The Global Alliance for Improved Nutrition (GAIN), a Swiss-based foundation, implemented a complementary feeding project to improve dietary quality among children 6-59 months of age living in Ethiopia by improving demand and access to eggs. Using a quasi-experimental design and two separate cross-sectional surveys at baseline and end-line, the evaluation seeks to determine the effects of the program on egg consumption, availability of eggs, caregivers' behaviours toward eggs, and caregivers' willingness to pay for eggs.

The Global Alliance for Improved Nutrition (GAIN), a Swiss-based foundation, implemented a complementary feeding project to improve dietary quality among children 6-59 months of age living in Ethiopia by improving demand and access to eggs. The complementary feeding project aimed to boost children's consumption of eggs. The intervention incorporated demand creation campaigns and supported selected delivery channels and producers who provided eggs to communities. GAIN's demand creation strategy was designed to complement the Ethiopian government's effort to use social and behavior change communication to encourage consumption of nutritious complementary foods. This campaign was implemented through the existing health extension system.

Areas included in the intervention arm received direct support for egg producers and suppliers and an egg demand creation campaign. Supply-side interventions included training for farmers, identification of distribution channels, mapping of retailers, and creation of linkages between egg producers and egg suppliers. Egg demand-creation activities were executed through above-the-line (ATL) and below-the-line (BTL) campaigns. The ATL campaigns included radio messages, bajaja branding, billboard mounting, and digital promotion. The BTL campaigns include market activation, road shows, sensitization workshops for key community groups, door-to-door promotion, and mobile promotion in collaboration with creative agencies and health extension workers. Both sets of activities focused on creating awareness around eggs as a daily nutritious food option for children.

Originally, the study intended to also increase availability of, and demand for, commercially-available complementary foods (i.e., Cerifam and Fafa), however, these components of the intervention were not delivered. Therefore, we have removed these components from the description and removed the outcomes that corresponded with these components of the intervention.

Using a quasi-experimental design and two separate cross-sectional surveys at baseline and end-line, the evaluation seeks to determine the effects of the program on egg consumption, availability of eggs, caregivers' behaviours toward eggs, and caregivers' willingness to pay for eggs.

Eligibility Criteria:
Inclusion Criteria:

* Living in the project areas
* Caregiver 18 years old or above

Exclusion Criteria:

* households without children between the ages of 6-59 months
Multi-level Interventions for STD Prevention Among Adolescents

Sexually active adolescents between the ages of 10 and 19 are at extremely high risk for sexually transmitted diseases (STD), including HIV, and teen pregnancy.The overall goal of this research program is to develop, implement and evaluate integrated multi-level interventions to prevent STD, including HIV, and pregnancy among adolescents. The study includes 12 high schools and 19 of their feeder middle schools in the Los Angeles Unified School District and the surrounding communities. Interventions will be implemented among parents, health care providers, and in schools in an integrated fashion with the goal of improving social context factors related to health outcomes among adolescents. The evaluation phase will include in-school surveys with adolescents at all middle schools

In the current study we plan to implement interventions at four social context levels, that is, with parents, providers or in other medical institutions, schools and community venues, to improve communication between adolescents and adults, facilitate increased access and utilization of health care services, and appropriate supervision of adolescents outside of school hours. As such the goals of the specific level interventions are as follows.

Among parents: (1) to enhance communication and relationship satisfaction; (2) increase parents participation in the healthcare of their adolescents; and (3) to enhance appropriate monitoring and supervision of adolescents.

Among school-based health care providers: (1) to increase access to and utilization of services by adolescents; and (2) to increase STD screening of adolescents.

In middle schools: (1) to increase access and utilization to supervised after-school activities, either at school or in the community; (2) to address quality and fidelity of health education curriculum provision and teacher training; (3) to increase parental participation in school-related activities.

In high schools: (1) to increase access and utilization to supervised after-school activities, either at school or in the community; (3) to address quality and fidelity of health education curriculum provision and teacher training; (4) to increase parental participation in school-related activities; (5) to increase awareness and utilization of school-based condom availability programs.

In community venues: (1) increase adolescents utilization of community-based clinical services; (2) to increase adolescent utilization of non-clinic-based screening; and (3) to increase utilization of community-based supervised activities for youth.

Activities will address these goals with the ultimate purpose of reducing adolescent risk for STDs, including HIV, and teen pregnancy through (1) increased age at first intercourse, (2) return to abstinence among sexually active adolescents, (3) decreased rates of unprotected sex among adolescents, (4) and increased screening and treatment of STD-infected adolescents.

Eligibility Criteria:
Inclusion Criteria:

* Student at participating school

Exclusion Criteria:

* None
Characterization of Signs and Symptoms of Participants With and Without Meibomian Gland Dysfunction

This is an exploratory study to evaluate endpoints used to characterize participants with and without meibomian gland dysfunction (MGD) and will evaluate the correlation between signs and symptoms of MGD. No investigational drug will be administered in this study.


Eligibility Criteria:
Inclusion Criteria:

-Participants characterized as with or without Meibomian Gland Dysfunction.

Exclusion Criteria:

* Lid heating therapy, therapeutic gland expression, or meibomian gland probing within 12 months of enrollment
* Contact lens use in the 30 days prior to enrollment
* Lid hygiene within 48 hours prior to enrollment
* Use of eye makeup within 8 hours of enrollment
* Eyelash growth-stimulating products within 30 days prior to enrollment
* Use of systemic vitamins and/or systemic supplements containing omega 3 fatty acids within 60 days of enrollment
* Use of systemic anti-histamines within 30 days prior to enrollment.
ProMRI ICD/CRT-D Post Approval Study

Following product approval, confirmation of appropriate VF episode detection after MRI exposure of the ProMRI ICD/CRT-D systems and to evaluate left ventricular pacing threshold changes post-MRI.


Eligibility Criteria:
Inclusion Criteria:

* ProMRI ICD/CRT-D system enabled with BIOTRONIK Home Monitoring.

Exclusion Criteria:

* None
Gene Expression in Predicting Outcome in Samples From Patients With High-Risk Neuroblastoma

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in RNA and predict how patients will respond to treatment. It may also help doctors find better ways to treat cancer.

PURPOSE: This research trial studies gene expression in predicting outcomes in samples from patients with high-risk neuroblastoma.

OBJECTIVES:

* To test the correlation of a previously published microarray gene expression signature with the gene expression obtained with the nCounter™ Analysis System using RNA isolated from formalin-fixed, paraffin-embedded (FFPE), high-risk neuroblastoma samples.
* To construct, test, and validate a novel robust classifier that can be readily integrated into the clinic.

OUTLINE: This is a multicenter study.

RNA samples extracted from paraffin-embedded tissue are analyzed for gene signature expression levels by nCounter™ Analysis System and correlated with published microarray expression data. Results are then used to develop a refined gene-expression-profile classifier of ultra high-risk neuroblastoma.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Formalin-fixed paraffin-embedded tumor sections linked to clinical and outcome data collected from high-risk neuroblastoma patients (n=100) treated at the University of Chicago, St. Jude Children's Research Hospital, Children's Memorial Hospital, or Texas Children's Hospital

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Total Arterial Revascularization (TAR)

Total arterial revascularisation with in-situ confihuration of BITA is superior than y-graft in patients underwent CABG.

The main hypothesis of the trial is that in-situ configuration of bilateral internal thoracic arteries is superior than Y-graft configuration for MACCE (mortality, myocardial infarction, repeat revascularization, stroke) during mid-term follow-up in patients with CAD who is shedueled for CABG.

Eligibility Criteria:
Inclusion Criteria:

* Coronary Artery Disease
* Stable angina
* The need for revascularization of anterior descending and obtuse margin arteries accoring to the 2018 ESC/EACTS Guidelines on myocardial revascularization
* Informed Consent Form

Exclusion Criteria:

* The diameter of the target arteries is less than 1 mm
* Stenosis of the subclavian arteries more than 60%
* STEMI less than 3 month
* Previous cardiac surgery
* BMI \>35
* COPD with FEV1 \<60%
* Concomitant pathology that requires simultaneous surgical treatment
* Cancer with life expectancy less than 5 years
Neurostimulation and Electromyographs Assessment of th TetraGraph in Healthy (Volunteers

TetraGraph is a newly developed EMG-based (electromyograph), quantitative, battery-powered neuromuscular monitoring system intended for daily clinical use. The primary aim of this clinical investigation is to examine the applicability (ease of use, equipment need, etc.), repeatability (precision or internal consistency) and performance (signal quality, accuracy of outcome, voltage of stimulation output before and during a stimulus) and tolerability of the Tetragraph device in healthy volunteers.

The primary endpoint will be assessment of the ability of the TetraGraph prototype to deliver neuro-stimulation, and assessment of the ability to acquire muscle action potentials and record these evoked responses on the SD-card. The study will be performed on healthy volunteers - 10 male and 10 female. Testing will be done at two separate stimulation/recording sites: ulnar nerve stimulation/abductor digiti minimi (ADM) muscle recording; and ulnar nerve stimulation/adductor pollices (AP) muscle recording. The side of testing (RIGHT vs. LEFT hand) will be determined a priori and randomly by the principal investigator, such that 10 volunteers each will be tested on the RIGHT and 10 on the LEFT hands. At each stimulating/recording site two stimulation protocols (single twitch stimulation and train-of-four stimulation) will be performed with growing current intensity (10-60 mA (milliAmps), in a 10 mA step-up fashion). Volunteers will rate the tolerability of each stimulation protocols on a visual analogue scale. EMG data will be recorded on the SD card and evaluated off-line.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Volunteer is American Society of Anesthesiology (ASA) physical status I-III (Tabl
* Volunteer has provided written informed consent

Exclusion Criteria:

* Presence of an underlying neuromuscular disease
* Use of medications known to interfere with neuromuscular transmission
* Presence of renal or hepatic disease
* Subject has only one upper extremity
* Subject has open sores at the skin sites needed for electrode application