cyrilzakka/clinical-trials huggingface dataset:
Safety and Effectiveness of BioTraceIO 360 for Planning, Monitoring and Assessment of Liver Tissue Ablation Procedures (PANORAMA2)

Pilot study planned to demonstrate the safety and effectiveness of the use of BioTraceIO 360 for Planning, Monitoring and Assessment of liver tissue ablation procedures

Single-center prospective single-arm clinical investigation.

Sample size - 10 subjects.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled and indicated for standard-of-care liver tumor ablation for either hepatocellular carcinoma (HCC) or metastatic liver tumor(s) microwave (MW) energy.
* Patient must have at least one prior CT or CECT scan (up to 6 months before enrollment).
* Tumor must be visualized on at least one diagnostic imaging modality (MRI or contrast-enhanced CT).
* Single tumor, or multiple tumors only if the distance between the ablated tumor and all other tumors allows for distinct separation between the necrotic zones.
* Distance between the tumor and the edge of any previous necrotic zones allows for distinct separation between the necrotic zones.
* At least 21 years of age.
* Able and willing to give informed consent.

Additional inclusion criteria for subgroup:

- Single ablation, using a single ablation needle, per tumor.

Exclusion Criteria:

* Planned ablation includes adjunctive means other than MW energy (e.g., ethanol, hepatic artery embolization, etc.).
* Planned ablation includes the use of more than two ablation needles, per tumor
* Ablation area cannot be visualized and monitored continuously using ultrasound throughout the entire ablation procedure.
* Pregnant or breastfeeding.
* Patient judged unsuitable for study participation by the physician for any other reason.
* Currently participating in another clinical trial of an unapproved investigational device or drug that has not concluded the follow-up period.
* Unable or unwilling to give informed consent.

Additional exclusion criteria for subgroup:

* Liver tumor that cannot be ablated with a single ablation needle, according to the investigator's clinical opinion.
* Planned ablation includes repositioning and/or overlapping ablations using a single ablation needle.
The Effect of「GTT-EGCG」on Acne Women

The aim of this study is to investigate the therapeutic effects of green tea extract on acne treatment and related hormone peptides by a double-blinded, randomized and controlled clinical trial.

change in acne lesions counts, hormone, quality of life

Eligibility Criteria:
Inclusion Criteria:

* Female patient
* 20 to 45 years of age
* moderate or severe acne vulgaris as defined by the Investigator's Global Assessment (IGA; score of 3 or 4 on a scale from 0 to 5)

Exclusion Criteria:

* Received systemic retinoid or hormone treatment in the previous 3 months.
* Abnormal liver enzymes or kidney function tests (1.5 times higher than the upper normal limit)
* abnormal blood chemistry
* Pregnant or breast feeding women or the intention of becoming pregnant
* Concurrent systemic illness
* PCOS
* Very severe acne(IGA score5)
The Efficacy of Thread Embedding Acupuncture on Pain Score, Neck Disability Index, and Pressure Pain Threshold for Myofascial Pain Therapy in the Upper Trapezius Muscle

Myofascial pain is characterized by myofascial trigger points, considered as a major cause of neck and shoulder pain in the working population. Thread-embedding acupuncture is a new acupuncture modality that can provide long-term stimulation aimed at prolonging its therapeutic effect that is similar to conventional acupuncture, such as analgesic effects. The goal of this randomized controlled trial is to evaluate and compare the effects of thread-embedding acupuncture and sham thread-embedding acupuncture as a therapy for myofascial pain in the upper trapezius muscle. The primary aim of this study is to investigate whether thread-embedding acupuncture therapy gives better and last longer results for myofascial pain of the upper trapezius muscle than sham thread-embedding acupuncture.

This is a clinical trial study to evaluate and compare the effects of thread-embedding acupuncture and sham thread-embedding acupuncture as a therapy for myofascial pain in the upper trapezius muscle. The subjects are 44 males/female with myofascial pain in the upper trapezius muscle and will be randomly assigned to 2 groups: (1) thread-embedding acupuncture and (2) Sham thread-embedding acupuncture. The subjects will receive a single treatment. The outcome will be assessed before treatment (baseline) and 3 days, 1 week, 4 weeks, 8 weeks after treatment. Patients and the outcome assessors will be blinded to the group allocation.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18-59 years.
* Subject with myofascial pain in the upper trapezius muscle.
* VAS score of 30-70 mm from 100 mm during activities (everyday activities or light exercise).
* Pain \> 3 months.
* Willing to participate in this research to completion and sign informed consent.

Exclusion Criteria:

* Fibromyalgia.
* Have had cervical spine surgery.
* Have done Dry needling therapy on the upper trapezius muscle in the last 9 days
* Have done thread acupuncture on the upper trapezius muscle in the last 6 months.
* Have performed pharmacopuncture on the upper trapezius muscle in the last 6 months.
* VAS score is more than 70 mm than 100 mm at resting.
* History of anti-inflammatory drug treatment in the previous 2 weeks.
* History of intra-articular steroid injections in the previous 3 months.
* There is a tumor, wound, or skin infection at the needle insertion area.
* Fever (≥ 37.5 oC).
* There is a hypersensitivity reaction in previous acupuncture therapy (metal allergy, severe atopy, keloids, or other skin hypersensitivity).
* Suffering from a blood disorder or taking blood thinners (anti-platelet or anti-coagulant drugs).
* Have a heart condition or uncontrolled diabetes.
* Blood glucose level (GDS) ≥200 mg/dL is checked by capillary blood using a glucometer.
RCT of Mailed Brochure to Boost Adherence to Screening Colonoscopy

The purpose of this study is to evaluate the effect of a mailed educational brochure on adherence to referral for screening colonoscopy. The comparison (or control) group receives no mailer, which is usual care.


Eligibility Criteria:
Inclusion Criteria:

Referrals for screening colonoscopy; Asymptomatic; age\>=50

Exclusion Criteria:

Referrals for diagnostic colonoscopy
Ultrasound Effect With Hyaluronate Injection on Risk of Fall in Geriatric Women With Knee Osteoarthritis

For many years' physiotherapists have been using ultrasound in treatment of knee osteoarthritis especially in geriatrics (people aged above 65 years) for its known therapeutic effect in relieving pain and improving knee function. Hyaluronan is used to treat osteoarthritis of the knee. Such treatments, called viscosupplementation, are administered as a course of injections into the knee joint, and are believed to supplement the viscosity of the joint fluid, thereby lubricating the joint, cushioning the joint, and producing an analgesic effect. Studies reveals the risk for falls increases with additional symptomatic OA lower limb joints and confirms in addition to gender factor; including female sex.

It is hypothesized that physical therapy by ultrasound might add some extra benefit on risk of fall when applied after intra-articular hyaluronate of Knee OA in female geriatrics. So, forty female geriatrics with ages ranged from 65 to 75 years, randomly will be selected from Ahmed Maher Teaching Hospital, Kasr el einy hospital, Charity clinic and Outpatient clinic of Badr university, referred to physical therapy by an orthopedic surgeon. All will be diagnosed as chronic OA of one or both knees where conventional therapeutic measures failed. They will be assigned to begin HA intra-articular knee injection by the orthopedic surgeon once weekly for 3 weeks. These patients will be randomly divided into 2 groups equal in number, group (1) the study group, they will receive HA intra-articular injection in addition to 12 sessions of therapeutic ultrasound, while group (2) served as the control group receiving only HA intra-articular knee injection.

Eligibility Criteria:
Inclusion Criteria:

* Patients' ages above 65 years.
* Patients diagnosed as chronic osteoarthritis of more than 5 years.
* The OA diagnosed as grade (III to V)
* Patients failed with conventional treatment.
* All patients followed up with the same orthopedic surgeon, and they took the same type of HA intra-articular injection (HA of High MW 3000 kDa).
* All patients were medically stable and do not suffer from any other diseases which may affect the trial results.
* All patients were not treated with analgesics or any medication which may cause misleading results.
* None of the patients received intra-articular hyaluronic acid injection for 1 year or intra-articular corticosteroid injection within the last 3 months.
* All patients didn't take or oral glucosamine or chondroitin supplements or stopped these drugs 2-3 months before participating in this study.
* Every patient signed a consent form.

Exclusion Criteria:

* Young individuals (their age is below 65 years old).
* Mild degree of OA (grade I \& II).
* Patients who had undergone knee arthroscopy, or any knee surgery.
* Patients with OA secondary to trauma.
* Patients with metal implants.
* Patients with CNS dysfunction.
Impact of Right Ventricular Pacing Determined by Electrocardiography

Typically pacemaker electrode has been attached to the right ventricular apex. This method lead to Non-physiological Ventricular contraction. It has been reported to cause by ventricular dysfunction. In conclusion, this study demonstrate that impact of right ventricular pacing determined by electrocardiography was planned.

Patients who has Atrioventricular block scheduled for artificial pacemaker Randomized select 1:1 apex beats and ventricular septal beat.

Eligibility Criteria:
Inclusion Criteria:

* Atrioventricular block, pacemaker scheduled

Exclusion Criteria:

* History of myocardial infarction
* Valvular heart disease (grade ≥ 2 )
* History of Left ventricular dysfunction ( ejection fraction \<50% or LV dimension \>60 mm in the pre-procedure echocardiogram)
A Phase 1 Dose Escalation Study of VX-973 in Healthy Participants

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of VX-973 in healthy participants.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility Criteria:
Key Inclusion Criteria:

* Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\^2)
* A total body weight of more than (\>) 50 kg
* Participants of non-childbearing potential
* Nonsmoker or ex-smoker for at least 3 months before screening

Key Exclusion Criteria:

* History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
* Any condition possibly affecting drug absorption, distribution, metabolism, or excretion

Other protocol defined Inclusion/Exclusion criteria may apply.
Effects of Sedation on Clinical, Gasometric and Respiratory Muscle Parameters in Critically Ill COPD Patients

the investigators conducted a randomized controlled trial in respiratory intensive care unit (RICU) of Assiut University Hospital. COPD patients admitted to RICU were included. Exclusion criteria include: Marked renal impairment, Liver cell failure, neurological disorders, age \<18 or \>70 and pregnancy.

Patients were randomly allocated to two groups. Midazolam was used for sedation in both groups. Richmond agitation-sedation score (RASS) was used to monitor level of sedation or agitation. Control group received daily interruption of sedation. intervention group managed by no-sedation strategy.

Primary outcome measure: changes in PaCO2 Secondary outcome measures include: changes in PH, heart rate, mean arterial blood pressure, respiratory rate, P0.1 and NIF.

The researchers conducted a randomized controlled trial in respiratory intensive care unit (RICU) of Assiut University Hospital. COPD patients admitted to RICU were included. Exclusion Criteria include: Marked renal impairment (creatinine \> 2mg/dl), Liver cell failure (Bilirubin\> 3mg/dl), neurological disorders, age \<18 or \>70 and pregnancy.

Patients were randomly allocated to two groups. Midazolam was used for sedation in both groups. Richmond agitation-sedation score (RASS) was used to monitor level of sedation or agitation. Control group received daily interruption of sedation. After intubation, patients received IV infusion of midazolam, gradually increasing dose till RASS reached -4 or -5. Infusion stopped at 7:00 AM. If the patient is awake no need for resuming infusion. If signs of discomfort occurred, infusion resumed at half of the prior dose, targeting conscious sedation (RASS 0: -3) Intervention group were managed by no-sedation strategy. Patients received bolus doses of midazolam only when needed, after atrial to control agitation by correcting the underlying cause. If the patient needed more than 3 bolus doses , IV infusion of midazolam was given by the daily interruption protocol as in the control group. No crossover was allowed between groups. Analysis was done by intension-to-treat principle.

Follow up arterial blood gas sampling was done baseline at intubation. 1hr., 2hrs., 12hrs., 24hrs. and 48hrs. after intubation. Recording of clinical monitoring parameters (hear rate, mean arterial blood pressure, respiratory rate) was done at the same intervals. Airway occlusion pressure (P0.1) and negative inspiratory force (NIF) were measured 48 hours after intubation to test affection of respiratory muscles in both groups.

Primary outcome measure: changes in PaCO2 Secondary outcome measures include: changes in PH, heart rate, mean arterial blood pressure, respiratory rate, P0.1 and NIF.

Eligibility Criteria:
Inclusion Criteria:

Critically ill patients diagnosed as COPD, admitted to the respiratory intensive care unit (RICU) of Assiut University Hospital.

Exclusion Criteria:

Marked renal impairment (creatinine \> 2mg/dl), Liver cell failure (Bilirubin\> 3mg/dl), neurological disorders, age \<18 or \>70 and pregnancy.
Stroke Research Initiative to Advance Equity

1. Assess patient-centered outcomes (PCOs) amongst stroke survivors and their caregivers in the MedStar Health system longitudinally.

   i. Utilize a community advisory board (CAB) of stroke survivors and their caregivers to identify the patient-centered outcome(s) that they determine to be most important and valuable to assess based on their lived experiences.

   ii. Collect the chosen PCOs at multiple time points using an electronic survey tool (e.g. Qualtrics, Tonic or RedCap)
2. Evaluate the impact of social determinants of health (SDoH) and experiences of discrimination on the chosen PCOs.
3. Examine whether there are differences in long-term PCOs amongst stroke survivors from different racial and ethnic groups.

2.2 Hypothesis: We hypothesize that stroke survivors that come from historically marginalized populations, specifically African American and Latinos, will have lower patient-centered outcome scores overall as compared to their Caucasian counterparts. In addition, we hypothesize that the difference PCO scores between Caucasian and African American and Latino populations will be due in part to experienced discrimination and not SDoH alone.

.


Eligibility Criteria:
Stroke Survivor:

Inclusion Criteria:

≥ 18 years old Acute Ischemic Stroke (AIS) or Intracerebral Hemorrhage (ICH) patients that have been cared for in the MedStar Healthcare system AIS of ICH in the last six weeks Ability to communicate in English, Spanish, Amharic, Mandarin Chinese or French (most common languages in the greater Washington, DC area)

Exclusion Criteria:

Transient Ischemic Attack (TIA) or Subarachnoid Hemorrhage (SAH) Unable to complete required forms Life expectancy less than 6 months

Caregiver Inclusion Criteria Age ≥ 18 Self-identify as primary caregiver for the stroke survivor Ability to communicate in English, Spanish, Amharic, Mandarin Chinese, French

Exclusion Criteria Unable to complete study survey forms Life expectancy less than 6 months
Evaluation of Metabolic Syndrome, Frailty, Locomotive Syndrome, Balance and Physical Fitness in Elderly Individuals

Metabolic syndrome (MetS) or syndrome X, which is increasingly prevalent in the world and in our country, is a disease that includes abdominal obesity, dyslipidemia, impaired glycemic control and hypertension components. It causes cardiovascular events such as myocardial hypertrophy, left ventricular diastolic dysfunction, atrial dilatation and atrial fibrillation. Low levels of physical activity can be caused by a wide variety of factors including environmental and genetic factors, age, race, sarcopenia, poor eating habits, postmenopausal period and smoking history. Factors such as genetic differences, diet, physical activity, age, gender and eating habits are reported to affect the prevalence of (MetS) and its components. Frailty is also emerging as a major issue for the elderly due to its debilitating effects on health outcomes. Frailty is a geriatric syndrome characterized by a gradual decrease in homeostatic tolerance and physiological reserve following exposure to stressors. Frailty predisposes older people to falls, delirium, hospitalizations and even death and is therefore considered a crucial transition between healthy ageing and disability. As a result of aging, degenerative changes in the central and peripheral vestibular system have been found. With age, the ability to regulate movement is impaired as a result of insufficient information in any of the sensory receptors or any disorder affecting the processing of these messages. This directly affects balance and postural control, leading to an increased risk of falls. In the light of the results of the studies in the literature, degenerative changes are observed in many systems in geriatric individuals and while the incidence of metabolic syndrome in these individuals is high, the number of studies evaluating their effects is not sufficient. Based on these deficiencies, it is aimed to examine metabolic syndrome, frailty, locomotive syndrome, balance and physical fitness in elderly individuals.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 65 and over,
* Volunteering to participate in the research
* No cooperation and communication problems

Exclusion Criteria:

* Individuals with neurological and orthopedic problems
* Uncontrolled hypertension
* Those with cardiac disorders
* Those with cooperation and communication problems
Comparison of Deep Serratus Anterior Plane Block and Combination of Deep and Superficial Serratus Anterior Plane Block

Video-assisted thoracic surgery (VATS) has become a common procedure in thoracic surgery. Severe postoperative pain may be encountered in patients undergoing VATS. Analgesic methods such as thoracic paravertebral block (TPVB), intercostal block, serratus anterior plane block (SAPB) and erector spina plane block (ESPB) are widely used for VATS. Among these methods, ultrasound (US) guided TPVB is the most preferred method. In recent years, the frequency of application of plane blocks as a component of multimodal analgesia has been increased. ESPB and SAPB are some of them. There are two techniques for SAPB application. In Deep SAPB (DSAPB) application, local anesthetic agent is given under the serratus anterior muscle. In the Superficial SAPB (SSAPB) application, the local anesthetic agent is given above the serratus anterior muscle. Since it is done by entering from the same point in two applications, it is possible to perform these two applications at the same time with a single needle entry. The mechanisms of regional analgesia techniques used after thoracic surgery operations are also different from each other. Therefore, it may be possible to obtain a more effective analgesic effect in patients by combining the mechanism of action of DSAPB and SSAPB , as in the multimodal analgesia method. This study seeks to evaluate the effect of DSAPB and combined DSAPB-SSAPB pain after VATS.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years old
* ASA physical status I-II-III
* BMI 18 to 30 kg/m2
* Elective video assisted thoracoscopic surgery

Exclusion Criteria:

* Patient refusing the procedure
* Emergency surgery
* Chronic opioid or analgesic use
The Effects of Craving and Abstinence From Cigarettes on Brain Metabolism in Smokers

Craving and withdrawal from smoking cigarettes are major factors for relapse. We investigated craving for cigarettes in smokers undergoing pharmacological treatment with Bupropion (Zyban). We compare cue-induced reactivity to smoking videos in smokers who were successfully treated with Bupropion to smokers who are still smoking. We measured the brain's metabolic activity in response to smoking and neutral cues in Positron Emission Tomography using FDG.

Craving and withdrawal from smoking cigarettes are major factors for relapse. We investigated craving for cigarettes in smokers undergoing pharmacological treatment with Bupropion (Zyban)for 2 months. We compare cue-induced reactivity to smoking videos in smokers who were successfully treated with Bupropion to smokers who are still smoking. We measured the brain's metabolic activity after exposure to videotapes showing smoking and neutral scenes in Positron Emission Tomography using FDG. There were 2 scanning sessions, one with a smoking videotape and one with a neutral video separated by a week. So far we have compared the brain's metabolic activity in 6 abstinent smokers and 6 still smokers.

Eligibility Criteria:
Inclusion Criteria:

* Cigarette smokers (over 1 pack a day)
* Age 20-65, male-females

Exclusion Criteria:

* Dependence on other substances
* Psychiatric diagnosis
* Neurological disorder
* Obesity
* Young persons
* Pregnant women
Effect of DHA Supplementation on Cognitive Performance and Growth in Chinese Children

The purpose of this study is to determine whether DHA supplement (in a daily dose of 300 mg) will improve the cognitive performance, associated metabolism and growth in normal children aged 6-12 years in primary schools.


Eligibility Criteria:
Inclusion Criteria:

1. Children aged 6-12 years from primary schools.
2. Healthy as assessed by a physician.
3. Willing to participate in the study, consume the test product and perform all measurements including cognitive testing, blood drawing, urine samples, anthropometry and questionnaires.
4. Willing to maintain current dietary habits and intend to stay in the study area for ≥ one year.
5. Informed consent signed by parent or caregiver and oral consent given by child.

Exclusion Criteria:

1. Children with obvious mental and physical handicaps.
2. Children taking medication which interferes with study measurements (e.g., psychoactive medications or medications expected to affect behavior and learning).
3. Taking dietary supplements already.
4. Suffering major life events (immediate family death, parents divorce, etc.) within six months.
Subserosal Laparoscopic Cholecystectomy

The aim is to study the safety and efficacy of subserosal laparoscopic cholecystectomy .


Eligibility Criteria:
Inclusion Criteria:

* Adult with age of or above 18 years.
* Diagnosis of chronic cholecystitis , symptomatic cholelithiasis

Exclusion Criteria:

* Previous operation or adhesion
* severe Acute Calculus pancreatitis
* gall bladder cancer
* Severe co-morbid conditions (uncontrolled diabetes, Hypertension, severe direct hyper bilirubinemia)
* Recurrent cases