cyrilzakka/clinical-trials huggingface dataset:
Comparison of Double Y-shaped Plates and Lag Screws in Fixation of Anterior Mandibular Fractures

This study is a prospective randomized controlled clinical trial. It was performed on sixteen patients with anterior mandibular fractures, to compare Double Y-shaped plates and Lag Screws in fracture fixation from clinical and radiographic perspectives.

This study is a prospective randomized controlled clinical trial. It was performed on sixteen patients with anterior mandibular fractures, selected from those admitted to the Emergency Department of Alexandria University Hospital. Ethical approval for the study was obtained from the regional Ethical Review Board of the Faculty of Dentistry, Alexandria University. A written informed consent was signed by patients before the operation.

Patients were divided equally into two groups, each consisting of eight patients. Assignment of each patient into one of either group was done using computer random numbers.

Group 1: underwent open reduction and internal fixation using two lag screws. Group 2: underwent open reduction and internal fixation using double Y-shaped plates.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders
* with age ranging from 25 to 45 years,
* suffering from anterior fractures of the mandible (symphyseal or parasymphyseal)

Exclusion Criteria:

* old fractures,
* infected fractures
* comminuted fractures
Increasing Atrial Base Rate Pacing to Reduce Atrial Fibrillation

This study aims to determine whether increasing atrial base rate pacing to achieve at least 75-80% atrial pacing in patients with sick sinus syndrome undergoing the implementation of dual-chamber pacemaker can be useful to prevent or decrease the atrial fibrillation during 6 months follow-up duration.


Eligibility Criteria:
Inclusion Criteria:

* Sick sinus syndrome patients having dual-chamber pacemaker
* Having paroxysmal AF defined as at least 2 episodes of AHR/AMS \>190 b/min lasting \>6 minutes
* Having normal atrioventricular conduction

Exclusion Criteria:

* Other clinical indications for pacing except sick sinus syndrome (bradycardia-tachycardia syndrome)
* History of acute coronary syndrome
* Significant heart valve disease
* Chronic AF before randomization
* Overt heart failure
* Malignancy
* Any reasons for antiarrhythmic medication use
* Inability to follow patients every 3 months
Nutritional Metabolomics: the Search for Dietary Exposure Variables 2

In the post-genomic era, a major challenge for health research is to understand the complex interactions among genetic, environmental and lifestyle factors including dietary intake. Unfortunately, such initiatives are hampered by the lack of accurate dietary intake assessment methods for large studies. The newly emerging field of metabolomics offers unique possibilities to characterize individual food intake, dietary patterns and effects of dietary intervention in large studies. The investigators propose to develop a platform to detect broad metabolomic responses to food intake in controlled trials as well as to use targeted metabolomics approaches to characterize dietary intake in longitudinal studies. Our laboratory has a long history of developing methodology for assessing nutritional status and effects of diet on metabolism. Here, the investigators team up with the Sahlgrenska Academy Core Facility and the Swedish NMR Centre at the University of Gothenburg, that offer modern metabolomics equipment and competence in bioinformatics, and use this in the context of nutrition research. To their knowledge, the investigators are among the first groups in the country to develop skills in metabolomics to assess dietary intake and effects of nutrition on metabolism, and probably the first to use two complementary platforms with both mass-spectrometry and nuclear magnetic spectroscopy. Hence, our methodological results should be useful to nutritional scientists nationally as well as internationally.


Eligibility Criteria:
Inclusion Criteria:

Healthy Body mass index 18.0-30.0, age 18-65 yrs

Exclusion Criteria:

Regular Medication or tobacco use Pregnancy or lactating
Panretinal Photocoagulation (PRP) Plus Ranibizumab for Proliferative Diabetic Retinopathy

The purpose of this study is to evaluate the effects of panretinal photocoagulation plus intravitreal ranibizumab for the treatment of patients with high risk proliferative diabetic retinopathy in terms of changes in visual acuity and neovascularization area.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* High risk proliferative diabetic retinopathy
* Visual acuity ≥ 20/800
* No previous laser treatment for diabetic retinopathy

Exclusion Criteria:

* Previous pars plana vitrectomy
* Systemic thrombo-embolic events
* Uncontrolled systemic hypertension
* Conditions avoiding adequated documentation
* Previous eye surgery in the last 6 months before inclusion in the study
A Qualitative Study on the Pain and Quality of Life of Patients With Fabry Disease

Background It is necessary to find out the difficulties experienced by patients with Fabry disease and their families, and to seek solutions for them. For this purpose, qualitative research with a patient-centered approach is useful.

Objectives The Objective of this study is to understand the various difficulties of patients with Fabry disease and to help them establish a comprehensive support system, medical, health, and welfare service system, and develop the direction and components of social and educational programs.

Methods The subjects of this study are patients who have been diagnosed with Fabry disease, and among them, are selected considering the selection and exclusion criteria, confirm consent for participation in the study after sufficient explanation, and then enroll. The target number of subjects is 10 people. Subjects who consented to the study had an in-depth interview centered on the in-depth interview questionnaire through the HA Research Institute, a specialized institution.

* The principle of saturation is observed by conducting 3 interviews per research subject.
* The duration of each interview per research subject is 50 to 60 minutes.
* All dictations of the research subjects were recorded with prior consent and then transcribed into a written copy.
* For 3 interviews, the number of interviews can be reduced to 1 or 2 by extending the interview time according to the research subject's request.
* As for the place of interview, the research counseling room at Severance Cardiovascular Hospital or the in-depth interview room in the HA Research Institute can be used, and the interview can be conducted at other places desired by the research subject at the request of the research subject.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects who have delayed diagnosis of Fabry disease or have experienced treatment refusal.
2. Subjects who have been diagnosed with Fabry name for more than 3 years or who have been treated for more than 1 year
3. Adults between the ages of 19 and 70 who have the ability to consent to participate in the research (excluding those subject to adult guardianship) and have the cognitive ability to dictate their experiences
4. Subjects who have experienced disadvantages and support in health-related quality of life, academic, job, family, social, and heterosexual relationships due to Fabry disease
5. Subjects who voluntarily gave written consent after hearing the explanation of the purpose and method of this clinical study

Exclusion Criteria:

1. Subjects who, in the opinion of the researcher, are unlikely to complete the study
The Effects Assessment of the Polygonatum Kingianum Extract on Endurance Performance and Anti-fatigue

To assess the efficacy of polygonatum kingianum extract on endurance performance and anti-fatigue


Eligibility Criteria:
Inclusion Criteria:

* Healthy male aged 30-60 years old
* Must read and sign the informed consent form
* During the experiment, do not change the lifestyle and eating habits
* Cooperate not to engage in high-intensity exercise 48 hours before each experiment

Exclusion Criteria:

* Subject who is not willing to participate in this study.
* People with serious diseases of heart, liver, kidney, endocrine and other organs (such as hypertension, diabetes, renal dysfunction and heart-related diseases) and mental patients
* People who have undergone surgery within 6 months or have lower limb injuries
* People who are allergic to Polygonatum kingianum extract
* Participate in other clinical trials related to anti-fatigue within four weeks of the trial
* Students who are currently taking courses taught by the principal investigator of this trial.
Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q4

Epinephrine is one of the important hormones in the defense of hypoglycemia. We will test the hypothesis that antecedent hypoglycemia will blunt the metabolic, neuroendocrine and cardiovascular effects of subsequent epinephrine infusion in Type 1 DM.

When a person had previously experienced bouts of low blood sugar, or hypoglycemia, his or her counterregulatory responses to hypoglycemia would be weakened. This is especially true and important for a person with Type 1 diabetes, because it will cause him or her to be vulnerable to another bout of hypoglycemia, and cause hypoglycemia unawareness, which can lead to serious or even life-threatening consequences. Epinephrine is one of the important hormones in the defense of hypoglycemia. We will test the hypothesis that antecedent hypoglycemia will blunt the metabolic, neuroendocrine and cardiovascular effects of subsequent epinephrine infusion in Type 1 DM.

Eligibility Criteria:
Inclusion Criteria:

* 28 (14 males, 14 females) conventionally treated Type 1 diabetic patients with HA1C \> 8.5%
* 28 (14 males, 14 females) intensively treated Type 1 diabetic patients with HA1C \< 7%
* 28 (14 males, 14 females) non-diabetic controls
* Age 18-45 yr.
* Had diabetes for 2-15 years if diabetic subject
* No clinical evidence of diabetic tissue complications, no cardiovascular disease
* Body mass index 21-27kg · m-2
* Normal bedside autonomic function
* Normal results of routine blood test to screen for hepatic, renal, and hematological abnormalities
* Female volunteers of childbearing potential: negative HCG pregnancy test

Exclusion Criteria:

* Prior history of poor health: any current or prior disease condition that alters carbohydrate metabolism and prior cardiac events and/or evidence for cardiac disease
* Hemoglobin of less than 12 g/dl
* Abnormal results following screening tests
* Pregnancy
* Subjects unable to give voluntary informed consent
* Subjects with a recent medical illness
* Subjects with known liver or kidney disease
* Subjects taking steroids
* Subjects taking beta blockers
* Subjects on anticoagulant drugs, anemic, or with known bleeding diseases
Change in Symptom Clusters in HNC Patients

Head and neck cancer (HNC) is the sixth most common malignancy worldwide, causing more than 379,000 deaths in 2015 notwithstanding the breakthrough in cancer screening and medical treatment. The primary treatment for HNC is a combination of surgery and radiotherapy, either delivered preoperatively or postoperatively. Although these treatments, especially the postoperative radiotherapy can greatly improve the survival of patients, they still have to pay a high price for numerous symptoms induced by radiation. On the other hand, research on symptoms clusters is an emerging field in oncology which aims to understand the complexity of multiple symptoms experienced by cancer patients. A thorough understanding of symptom clusters help informs the development of comprehensive care plans which target a group of symptoms that is likely to coexist, thus easing the total symptom burden in cancer patients.To date, there has been a paucity of evidence regarding symptom clusters of HNC. To address the gap in existing literature, this study described the symptom clusters among HNC patients who were treated with surgery with a combination of postoperative radiotherapy. In addition, a longitudinal approach was employed to examine the change in symptom clusters throughout the treatment course.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed with HNC,
* Aged older than 18 years,
* Without receiving any radiotherapy prior to surgery,
* No cognitive impairment and able to communicate in Mandarin or Taiwanese

Exclusion Criteria:

- Undergoing any concurrent treatment for cancer.
Pilot Study of the CHILLS Cryotherapy System for the Treatment of OSA

This is a prospective, multicenter, non-randomized single-arm safety and efficacy study to:

* Collect data to evaluate the safety of CHILLS cryotherapy to treat OSA in patients with moderate to severe disease.
* Evaluate the chronic performance of the CHILLS system and collect clinical measures for therapy effectiveness that will be used to demonstrate safety and effectiveness in the next clinical study.

The study will enroll up to 3 sites in Latin America, enrollment is competitive.

Up to 70 subjects will receive treatment and be followed through their 3-month visit.

Long-term follow-up will continue every 6 months out to 2 years post-procedure, with an option to follow patients up to 5 years.

Eligibility Criteria:
Inclusion Criteria:

Likely suffer moderate to severe OSA based on history and physical or have an established diagnosis of moderate to severe OSA (AHI ≥ 10) based on a prior sleep study.

A confirmation baseline sleep study will be performed after enrollment to verify AHI ≥ 10 and ≤ 50, and mixed and central apneas total ≤ 25% of apneas for continued eligibility.

Have either failed Positive Airway Pressure (PAP) therapy or decline PAP therapy

BMI of 25 - 40 kg/m2 at enrollment

Negative result for COVID-19 polymerase chain reaction (RT-PCR) test and absence of clinical symptoms for long COVID-19 relating to deterioration of taste, smell.

Exclusion Criteria:

Unable or incapable of providing informed written consent

Unwilling or incapable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires
Multilevel Intervention for Preventing Men's Use of Violence in Urban South Africa (Sonke CHANGE Trial)

South Africa has one of the highest rates of violence towards women globally. However, little is known about how to prevent men's use of violence. The Sonke CHANGE Trial tests an intervention that targets men as individuals, groups, and community members in a peri-urban setting in South Africa. Eighteen neighborhoods will be randomly assigned to either the intervention condition or a control group. By speaking to men at baseline, 12 months, and 24 months, investigators will learn whether violence and other health behaviors shift over time. Alongside the trial, qualitative research will explore how the intervention took place and why participants may change attitudes or behaviors.

This study will refine and evaluate a multi-level model for reducing violence against women and girls in urban South Africa.

The intervention is a refinement of an existing gender-transformative programme that includes community mobilisation and advocacy. Called the Sonke CHANGE intervention, it will extend beyond a conventional group-based workshop approach to address the multi-level nature of violence and create an enabling environment for men to embrace more equitable forms of masculinity. Given the strong associations between masculinities and men's use of partner violence, now is an opportune moment to test the Sonke CHANGE model to determine its impact on men's use of violence.

The multi-level Sonke intervention will be evaluated using a cluster randomised controlled trial design. In a peri-urban setting of Diepsloot, neighbourhood "clusters" (n=18) will be randomly assigned to receive the intervention or a wait-list condition. Baseline, 12 month, and 24 month measures will assess changes in primary outcomes (men's reported use of intimate partner and non-partner violence) and secondary outcomes (severe violence, masculinity norms, harmful alcohol use, mental health). Formative qualitative research will explore the environmental context of Diepsloot, community views on violence, men's mobility, and their experiences of fathering. A longitudinal process evaluation will explore intervention delivery, unfolding of the advocacy element of Sonke CHANGE intervention, and potential mechanisms to change amongst participants.

Eligibility Criteria:
Inclusion Criteria:

* between 18 and 40 years of age (inclusive)
* lives in a trial cluster
* willing to participate on basis of written, informed consent

Exclusion Criteria:

* younger than 18 years or older than 40 years
* lives outside of a trial cluster
* unwilling to participate or sign written, informed consent
Pilot Study Evaluating Stress Response and Immune Function in Mechanically Ventilated Patients With Alcohol Use Disorders Treated With Propofol or Midazolam

The aim of this study is to evaluate the effects of the sedatives propofol and midazolam on stress response and immune function in critically ill patients with alcohol use disorders who are undergoing mechanical ventilation.

No detailed description

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of alcohol use disorders
* Need for invasive mechanical ventilation
* Need for continuous intravenous infusion of sedative(s)

Exclusion Criteria:

* Age \< 18 years
* Pregnant women
* Prisoners
* Receiving propofol prior to randomization
* Patient experiencing active alcohol withdrawal
* Immunosuppression
* Shock
* Attending physician does not feel patient is candidate to receive either propofol or midazolam
* Patient has contraindication(s) to receiving either propofol or midazolam
* Inability to enroll patient within 96 hours after initiation of mechanical ventilation
* Transfer from another intensive care unit
Journey 2 Multi Center Kinematic Study

The objective of this study is to determine and compare the in vivo kinematics and vibroarthrography (VAG) signals for subjects implanted with Journey II Bi-Cruciate Stabilized (BCS), CR (Cruciate Retaining), and Bi-Cruciate Retaining (XR) TKAs.


Eligibility Criteria:
Inclusion Criteria:

1. Patients in the age range of 18 years to 85 years (both inclusive)
2. Patients who have a BMI less than 35
3. Patients who do not have previous surgery on the implanted knee that might restrict their movement
4. Patient who are at least 6 months post-operative
5. Patients who do not experience any pain or other post-operative complications
6. Patients who have a stable TKA and can perform a deep knee bend activity
7. Patients who are willing to participate in this study and are willing to sign appropriate HIPAA and informed consent forms
8. Subjects will have a Journey II knee system

Exclusion Criteria:

1. Pregnant, potentially pregnant, or lactating females. To satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. A pregnant person will not be allowed to participate in the study.
2. Patients who have currently enrolled in a fluoroscopic study within the past year.
3. Patients currently involved in any personal injury litigation, medical/legal or workman's compensation claims.
4. Patients with known drug or alcohol abuse histories or psychological disorders that could affect ability to complete all aspects of the study.
5. Patients with neurological or musculoskeletal disorders that might adversely affect weight-bearing motion ability
6. Subjects who are unable to perform a deep knee bend.
7. Subjects who are unwilling to sign Informed Consent/ HIPAA documents.
8. Subjects without the required type of knee implant.
Open-label Study of Levetiracetam Intravenous Infusion in Children (4-16 Years Old) With Epilepsy

Keppra injection is approved in the US as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. The objective of the current study is to assess the safety, tolerability, and pharmacokinetics, of this formulation in children aged 4 to 16 years.

The primary objective of this study was to evaluate the safety and tolerability of levetiracetam intravenous 15-minute infusion administered every 12 hours, either as adjunctive treatment or monotherapy in children (4 to 16 years old) with epilepsy (except status epilepticus), either after switching from the equivalent levetiracetam oral dose administration or as a new antiepileptic treatment.

The evaluation period was to be considered as one complete set of 4 Pharmacokinetic (PK) samples for a maximum of 4 days;

* For children already taking levetiracetam oral tablets or oral solution prior to entering the study, the levetiracetam intravenous (LEV IV) dose will be equivalent (mg-for-mg) to their oral dose. The first intravenous (IV) infusion was to be administered 12 hours after the last oral dose of levetiracetam.
* For children not taking levetiracetam oral tablets or oral solution prior to entering the study:

  * If weight \< 50 kg: dose of levetiracetam intravenous (LEV IV) dose will be calculated on the basis of their weight at 20 mg/kg/day (i.e. 10 mg/kg twice daily).
  * If weight ≥ 50 kg: dose of levetiracetam intravenous (LEV IV) will be 1000 mg/day (i.e. 500 mg twice daily).

However, when necessary for the safety of the subject or when the investigator deemed it appropriate the levetiracetam intravenous (LEV IV) dose could be modified after one day.

Subjects were hospitalized for the duration of the levetiracetam IV treatment.

Eligibility Criteria:
Inclusion Criteria:

* Male or female between 4 and 16 years of age, inclusive
* The subject suffers from epilepsy (except status epilepticus)
* The subject is requiring levetiracetam IV treatment in place of oral therapy for a short period of time

Exclusion Criteria:

* The subject has difficult venous accessibility
* History of status epilepticus during the 3 months prior to visit 1.
* The subject is taking felbamate at visit 1 or has been taking it in the past.
Bioequivalence of a FDC Tablet of Linagliptin/Metformin (2.5mg/750mg) Extended Release in Healthy Subjects

The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose combination (FDC) tablet containing linagliptin and metformin extended release compared to the free combination of linagliptin and metformin extended release.


Eligibility Criteria:
Inclusion criteria:

- Healthy male or female subjects

Exclusion criteria:

- Any relevant deviation from healthy condition
A Study to Assess the Effect of Tocilizumab on Signs and Symptoms in Patients With Rheumatoid Arthritis

This single arm, open label study will assess the safety and efficacy, with regard to reduction of signs and symptoms,of treatment with tocilizumab in patients with moderate to severe active rheumatoid arthritis. Patients will receive tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions. Patients already receiving methotrexate at entry into the study may continue with their treatment together with tocilizumab.The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients,\>=18 years of age;
* rheumatoid arthritis diagnosed \>8 weeks and \<4 years prior to baseline;
* naive to, or not responding well to, methotrexate;
* swollen joint count \>=8 (66 joint count) and tender joint count\>=8 (68 joint count) at screening and baseline.

Exclusion Criteria:

* rheumatic autoimmune disease other than rheumatoid arthritis;
* patients with functional class IV rheumatoid arthritis;
* history of, or current, inflammatory joint disease other than rheumatoid arthritis, or other systemic autoimmune disorder.