cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Active Sentry System During Cataract Surgery With the Centurion Phacoemulsifier

Each new generation of phacoemulsification system has aimed to optimize the control of fluidics and the delivery of energy during phacoemulsification. Nicoli CM et al., (J Cataract Refract Surg 2016;42:157-162) suggested a better anterior chamber stability when using an active fluidics system. Malik PK et al., (Eye and Vision 2017;4:22) showed that using an IOP based phacoemulsification system in association with the use of an Intrepid balanced tip provides a reduction in CDE (Cumulated Dissipated Energy and EFU (Estimated Fluid Usage). It has also been shown that a lower CDE provides obvious benefits: less endothelium cells damages and lower complication rates (Mady MA et al., Clin.Ophthalmol. 2012; 6:503-10).

The latest technologies, i.e. the Active Sentry Handpiece and Hybrid tips, have been introduced to further improve the safety of phacoemulsification. The Active Sentry system has moved pressure sensors closer to the operated eye, hence further reducing the risk of surge during procedures. (Thorne A et al. Phacoemulsifier occlusion break surge volume reduction, J Cataract Refract Surg. 2018;44:1491-1496). The Hybrid tips have been designed to prevent posterior capsule rupture in the event of contact with the capsule.

This new technology allows phacoemulsification procedures under reduced infusion pressures and a "high-vacuum - low energy" strategy which may lead to a safer procedure.

Data from this study will try to demonstrate that cataract surgeries with Active Sentry will need less CDE and therefore may be safer, due to the surge effects decrease. This CDE parameter will be analysed according to differents subgroups: Presence of hybrid tip or balanced tip, cataract score based on the WHO nuclear grading recommendation (Thylefors B et al., (2002) The WHO Cataract Grading Group, Ophthalmic Epidemiology, 9:2, 83-95) The recent experiences conducted in real world condition in different sites have suggested that Centurion with AS was able to improved settings: maximum vacuum and UltraSound (US) time reduction and as a consequence a 20 to 30% CDE reduction.


Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients undergoing unilateral or bilateral cataract surgery with the Centurion phacoemulsifier, with the ability to give informed consent.
* Patients will undergo the cataract surgery with or without the Active Sentry module and with or without hybrid tip according to centers practice.
* Patients will undergo a cataract scoring (nuclear grade 1 to 3) prior surgery as described in the WHO recommendation:

Exclusion Criteria:

* Patients with :
* pupil dilation \<5mm
* zonular defects
* corneal opacities
Physical Activity, Appetite and Food Intake in Older Adults (PHYSISAT)

This study aims to assess the effect of physical activity on food intake and appetite in older adults (≥ 65 years) and to investigate the relationship between older adults' eating behaviours, body composition and physical activity.

* To investigate the effect of physical activity on food intake and appetite in older adults (≥ 65 years).
* To examine the relationship between older adults' (≥ 65 years) eating behaviours, body composition and physical activity.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, living independently and self-reported;
* Aged ≥ 65 years;
* Having the ability to understand the study procedures.

Exclusion Criteria:

* Being obese (BMI \> 30 kg/m2);
* Smoking more than 10 cigarettes a day;
* Having a disease such as cardiovascular disease and other chronic diseases (diabetes, thyroid disorders, cancer, heart, lung and kidney disease;
* Taking medications known to influence appetite, food intake or body weight in the past three months;
* Changing their diet and exercise in the last 3 months;
* Having unexpected weight loss in the last 3 months.
Efficacy and Safety of Combined Thread Embedding Acupuncture With Auricular Acupuncture for GERD

Gastroesophageal reflux disease (GERD) is increasingly prevalent today. Proton-pump inhibitors (PPIs) are the primary treatment, yet their effectiveness remains limited. Various acupuncture methods have shown promise in treating GERD. Among these, thread embedding acupuncture (TEA) and auricular acupuncture (AA) offer the advantage of prolonged treatment per intervention, significantly reducing healthcare visits for procedures, particularly beneficial for conditions requiring extended therapy. This has led to the widespread application of TEA and AA in GERD treatment. However, evidence supporting their effectiveness remains inconclusive. In this study, we aim to assess the efficacy and safety of combining TEA with AA for treating GERD. According to traditional medicine, treatment should be pattern-based. Thus, we will focus on patients exhibiting the Liver Qi Invading Stomach pattern, as reports indicate its prevalence among GERD patients.

Patients with GERD diagnosed through the GerdQ score and presenting the traditional medicine pattern of Liver Qi invading Stomach, meeting the inclusion and not the exclusion criteria, will be included in the study. Upon randomization, participants will be allocated into two groups: the control and intervention groups.

The study spans four weeks. Both groups will receive standard GERD treatment following current guidelines, which include PPIs, additional antacids as required, and lifestyle modifications. The intervention group will receive an additional combination of thread embedding acupuncture therapy (TEA) every other week and auricular acupuncture (AA) weekly.

Patients will undergo weekly follow-up examinations. Symptom assessment, quality of life evaluations using specific questionnaires, and antacid medication usage will be monitored weekly. Adverse effects (AE) related to the treatment will be documented throughout the trial.

Eligibility Criteria:
Inclusion Criteria:

* Men or women aged from 18 to 60 Years
* GerdQ score of eight or higher
* Having heartburn and/or regurgitation on two days per week or more
* Diagnosis of GERD with Liver Qi Invading Stomach Pattern

Exclusion Criteria:

* Any prior endoscopy-confirmed structural diseases
* Uncontrolled inflammatory bowel disease, chronic or genetic conditions, alcohol or drug abuse history
* Alarming symptoms indicating gastric cancer, complicated ulcers, or serious illnesses
* History of esophageal or gastrointestinal surgery
* Current use of medications impacting GERD treatment or assessment
* Recent (within two weeks) Western Medicine or Traditional Medicine treatment for GERD
* History of hypersensitivity reactions to any components involved in the intervention
* Pregnancy or breastfeeding
* Current participation in any other clinical trials
Managment of Cardiorespiratory Arrest

CPR will be done based on American Heart Association Guidelines for Cardiopulmonary Resuscitation (2015) and Emergency Cardiovascular Care of Pediatric and Neonatal Patients.

the present study is to assess the quality of care and management of children with cardiorespiratory arrest admitted to assuit university children hospital according to the American Heart Association Guidelines for Cardiopulmonary Resuscitation (2015) and Emergency Cardiovascular Care of Pediatric and Neonatal Patients searching for defect,obstacles,or need to improve health service.

CPR will be done based on American Heart Association Guidelines for Cardiopulmonary Resuscitation (2015) and Emergency Cardiovascular Care of Pediatric and Neonatal Patients.

Eligibility Criteria:
Inclusion Criteria:

* Seriously ill Patients who will be admitted with or will be developed cardiorespiratory arrest and undergo CPR.

Age2 month to 18 years. Both sex.

Exclusion Criteria:

* Traumatic cause (blunt, penetrating, burn) of arrest
Central Sleep Apnea Prevalence and Impact on Cognitive Function in Patients with Heart Failure with Reduced or Mildly Reduced Left Ventricular Ejection Fraction

Study to assess the prevalence of central sleep apnea in patients with heart failure with reduced or mildly reduced left ventricular ejection fraction (LVEF \<50%) followed by case-control study to assess the link between central sleep apnea and cognitive function

The study will be conducted in two phases: prevalence phase and cognitive phase.

Adult patients with HFrEF/HFmrEF will perform a home sleep apnea test (HSAT). Patients will be assigned to one of the following groups based on their sleep study results: CSA, other SDB, or no SDB. This constitutes the prevalence phase of the study.

The cognitive phase of the study is a case-control study that will assess cognitive function in 20 patients in the CSA group (case) and 20 patients in the no SDB group (control).

Eligibility Criteria:
Prevalence Phase Inclusion Criteria:

1. Diagnosed with heart failure with reduced or mildly reduced left ventricular ejection fraction (LVEF \<50%) at least 3 months prior to enrollment
2. New York Heart Association (NYHA) functional class II-IV
3. Treated and optimized on heart failure guideline directed medical therapy as indicated for at least 4 weeks, including angiotensin receptor-neprilysin inhibitors (ARNI) (or angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blocker (ARB)), aldosterone receptor antagonists, beta-blockers and/or sodium glucose co-transporter 2 (SGLT-2) antagonists
4. Age 50 years or older
5. Signed Institutional Review Board (IRB) or Ethics Committee (EC) approved informed consent
6. In the opinion of the investigator, subject is willing and able to comply with the protocol, including the cognitive function assessment

Prevalence Phase Exclusion Criteria:

1. Hospitalized for heart failure-related complications in the last 4 weeks
2. History of SDB and/or prior or ongoing treatment for SDB or tested for SDB within the prior year

Cognitive Phase Inclusion Criteria:

1. AHI ≥ 15 events per hour and CAHI ≥ 50% of total AHI (Case group) or AHI \< 5 events per hour (Control group) based on the baseline HSAT
2. Per the patient and investigator, willing and able to postpone CSA treatment until completion of the study assessment visit (Visit 3)

Cognitive Phase Exclusion Criteria:

1. Color blindness
2. Currently taking opioids
3. Has taken medications for memory/cognition within the last 3 months (including but not limited to cholinesterase inhibitors and/or glutamate regulators)
4. Cerebrovascular accident (stroke or transient ischemic attack) in the last 12 months
5. Diagnosed with neurological disease including but not limited to history of seizures, meningitis, traumatic brain injury, amyotrophic lateral sclerosis, multiple sclerosis, attention-deficit/hyperactivity disorder (ADHD) or autism.
Impact on Linkage to HIV Care With Point of Care CD4 Testing and Home-based HIV Testing in Kenya

Randomised Controlled Trial to Assess Accuracy, Feasibility, Acceptability, Cost Effectiveness and Impact of Point of Care CD4 Testing on HIV Diagnosis, Linkage to Care and Time to Antiretroviral Therapy Initiation among HIV Infected Patients in Rural Western Kenya.


Eligibility Criteria:
Inclusion Criteria: adults living in the study catchment area (Gem Village, Nyanza province Western Kenya) served by one of 23 HIV clinics and 3 referral labs

* Not having received HIV care in prior 6 months if known HIV+

Exclusion Criteria:

* current HIV care or HIV care within last six months
Impact of v Release on Dysphagia in Patients With Traumatic Brain Injury

The goal of this clinical trial is to explore Clinical Effect of Myofascial Release Therapy in Dysphagic Traumatic Brain injured Survivors. The main question it aims to answer is:

• Can Myofascial Release Therapy improve swallowing function in Traumatic Brain injured Survivors? Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Myofascial Release Therapy. The study lasts 21 days for each patient. Researchers will compare the Functional Oral Intake Scale, Penetration-Aspiration Scale, Swallowing Quality of Life to see if the Myofascial Release Therapy can help improve the situation.

Myofascial release, also known as fascial release or fascial manipulation, is a physical therapy used to treat muscle and fascial tissue tension or pain. It involves applying appropriate pressure and stretching to release tight fascia and soft tissues, improving blood circulation, alleviating pain, and promoting rehabilitation. The goal of this clinical trial is to explore Clinical Effect of Myofascial Release Therapy in Dysphagic Traumatic Brain injured Survivors. The main question it aims to answer is:

• Can Myofascial Release Therapy improve swallowing function in Traumatic Brain injured Survivors? Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Myofascial Release Therapy. The study lasts 21 days for each patient. Researchers will compare the Functional Oral Intake Scale, Penetration-Aspiration Scale, Swallowing Quality of Life to see if the Myofascial Release Therapy can help improve the situation.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years, meeting the diagnosis of severe Traumatic Brain Injury.
* presence of no contraindication for enteral nutrition;
* with stable vital signs and no severe liver or kidney dysfunction, metabolic disorders, cardiovascular diseases, or multiple complications;

Exclusion Criteria:

* complicated with other neurological diseases;
* damaged mucosa or incomplete structure in nasopharynx;
* tracheostomy tube plugged;
* unfeasible to Myofascial Release;
* simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.
The Effect of Paratracheal Pressure on the Glottic View

Paratracheal pressure may have a role in the prevention of pulmonary aspiration. The effects of paratracheal pressure on glottic view, ease of facemask ventilation, or tracheal intubation are not studied yet. In this study, the subjects are divided into two groups (group I: paratracheal pressure applied during induction of anesthesia, group II: conventional Sellick's maneuver applied during induction of anesthesia). Investigators will assess the glottic view during direct laryngoscopy.

Primary outcome:

-Cormack-Lehane grade

Secondary outcome:

* POGO score before and after application of each intervention
* Difficulties of mask ventilation after application of each intervention
* Inspiratory pressure and tidal volume during manual mask ventilation
* Rates of worsening of the glottic view after intervention
* The difficulty of endotracheal intubation
* Intubation time

Eligibility Criteria:
Inclusion Criteria:

Adult patient undergoing elective surgery with general anesthesia

Exclusion Criteria:

A patient who does not agree to participate in this study A patient who has a history of cervical/esophageal operation A patient who has a risk of gastric regurgitation A patient who has atherosclerosis of the left carotid artery or history of stroke or angina in 3 months.
Evaluation of Double Tract Reconstruction After Total Gastrectomy in Patients With Gastric Cancer

The purpose of this study is to evaluate the double tract reconstruction after total gastrectomy in patients with gastric cancer. A prospective randomized controlled trial was conducted to compare double tract method with Roux-en-Y method

Patients with gastric cancer were intraoperatively randomized for R-Y reconstruction or DT reconstruction after total gastrectomy.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven adenocarcinoma without esophageal invasion, tumor status T1-2
* Age 80 years or younger
* No distant metastasis

Exclusion Criteria:

* Carcinoma in the remnant stomach
* Stage intravenous (IV)
* History of laparotomy
* History of serious heart disease
* Liver cirrhosis or chronic liver disease with indocyanine green excretion test at 15 min of 15% or more
* Absence of informed consent
Hyvinkää Childhood Obesity Study (HCOS), Randomized Controlled Clinical Trial for Effectiveness and Costs of a 1-year Lifestyle Intervention.

The aim of this study is to evaluate the effects of lifestyle intervention on the management of childhood overweight and to explore the factors that contribute to the outcome, as well as the costs for the health care system. The hypotheses of the study are that lifestyle intervention is efficient in reducing BMI-SDS and thus effective in preventing overweight to progress to obesity, and it is also cost effective.

The research is necessary for the development of overweight treatment, and try to find out the optimal duration and intensity for the treatment and content useful for clinical work.

Methods and analyses: The aim of this study is to recruit 80 children and to randomize them either to an intervention group or a control group with standard care. Intervention group receive intensive, family-based diet and physical activity counseling, deliver by a multidisciplinary team of a pediatrician, a nurse and a clinical nutritionist. Control group do not receive any lifestyle intervention during the study. The inclusion criteria are weight-for-height ≥+40% or ≥+30% and increasing and age of 6-12 years. All participants fill out the study questionnaires and plasma samples are taken at baseline and at 12 months. Outcome variables will be compared between intervention and control groups.

Eligibility Criteria:
Inclusion Criteria:

weight for height at least + 40 % or ≥ 30 % and it is rising

Exclusion Criteria:

Clinical diagnosis of endocrine or mental diseases.
Comparison of Nikkomycin Z Bioavailability Under Fed and Fasting Conditions

The primary purpose of this study is to evaluate if eating a high fat meal versus not eating any food affects how the study drug (Nikkomycin Z) is absorbed into the body. The second purpose is to gain further information about the safety of Nikkomycin Z in healthy adults.

To compare the single-dose bioavailability of Nikkomycin Z 500 mg (two 250 mg capsules) under fed and fasting conditions.

Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age and not over 40 years of age
* Be male, or female (non childbearing potential or using adequate contraception)
* Have a body mass index between 18 and 29 kg/m2
* Able to understand the study and give written informed consent
* Be determined healthy based on a medical and laboratory evaluation

Exclusion Criteria:

* Patients under the age of 18 years or over 40 years of age
* Current smoker or history of smoking within 3 months of participation
* Inability to comprehend study and provide written informed consent
* Inability to comply with the study requirements
* History of or current evidence of major organ disease
* Renal disease - serum creatinine \> 1.5 mg/dL, significant hematuria or proteinuria, known structural abnormality or chronic kidney disease
* Hepatic disease - active viral hepatitis, history of hepatitis B or hepatitis C, bilirubin \> 2.0, ALT or AST above normal upper limit for laboratory, alcoholic liver disease, other chronic liver disease
* CNS disease or cognitive dysfunction - any past history of epilepsy, CNS infections, stroke, CNS bleed, severe headaches, major psychiatric illness, or current mental status changes
* Lung disease - history of severe asthma, COPD, pulmonary tuberculosis, or other major lung disease
* Cardiac disease - history or current evidence of ischemic coronary artery disease, myocardial infarction, heart failure, or significant arrhythmia
* Gastrointestinal disease - presence of inflammatory bowel disease, difficulty swallowing, or any gastrointestinal probably that would limit taking oral medications or that may compromise absorption of oral medications
* Cancer - History of hematologic malignancy or solid tumor excluding basal cell carcinoma limited to the skin within the past 5 years
* History of autoimmune or inflammatory disease such as rheumatoid arthritis and lupus
* Immunocompromised state - solid organ transplant, cancer chemotherapy, stem cell transplant with graft versus host disease, immunosuppressive therapy, or HIV infection
* Recent weight loss of greater than 10%
* Any other history or evidence of disease that in the opinion of the physician would increase the risk for the subject for clinical trial participation
* Regular use of prescription medications, over-the-counter medications, or dietary/herbal supplements within 14 days of day 1. Occasional use of acetaminophen or over-the-counter NSAID within the 14 day window may be allowed at the P.I. discretion
* Subjects who received another investigational drug within 30 days of enrollment
Staccato Zaleplon Single Dose Pharmacokinetics

The purpose of the study is to determine the safety, tolerability and pharmacokinetics of zaleplon delivered by the Staccato thermal aerosol system in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects between the ages of 18 to 55 years, inclusive who are in good general health

Exclusion Criteria:

* Subjects with a history of allergy or intolerance to zaleplon. Subjects who have any other disease or condition, by history, physical examination, or laboratory abnormalities that in the investigator's opinion, would present undue risk to the subject, or may confound the interpretation of study results.
3D Geplante Osteosynthesen Mit Patientenspezifischen Zielvorrichtungen

Goal of this study is to evaluate the accuracy of 3D computer-planned fracture fixation with patient-specific instruments for clavicle, upper extremity, lower extremity and pelvis fractures compared with the standard procedure of fracture fixation.

The research hypothesis is: The medical product permits the fracture fixation of clavicle, upper extremity, lower extremity and pelvis fractures to be more accurate compared with standard procedures of fracture fixation. Accuracy is evaluated by calculating translation and rotation comparing the postoperative 3D model versus the preoperative 3D plan.

Secondary outcome is an assessment of the surgical outcome using validated outcome instruments for each fractured body part like "Patient related wrist Evaluation" (PRWE) scores for distal radial fractures, as well as evaluation of range of motion.

Eligibility Criteria:
Inclusion Criteria:

* fracture of clavicle, upper extremity, lower extremity or pelvis,tibia, fibula,Femur, with indication for fracture Fixation
* clinical indication for a computed tomography of the fractured bone
* \>18 years of Age
* Patient is able to give informed consent

Exclusion Criteria:

* pregnancy or nursing women
* non-compliance of the patient to follow the clinical study protocol, drug abuse or alcohol abuse
* participation in a different clinical Trial within the last 30 days before inclusion or during the study
* allergy to Polyamid PA 2200
* no available technique for fracture Fixation which could be performed, in case of applying the medical device is not possible.
* Applying the medical device is not possible, because of technical or anatomical reasons.
* other clinical significant accompanying symptoms (tumor, infection)