cyrilzakka/clinical-trials huggingface dataset:
DTM (TM) Spinal Cord Stimulation (SCS) Study

Prospective, multi-center, open-label, post-market study to evaluate the efficacy and energy use of a low energy DTM™ (DTM-LE) SCS therapy for pain relief.

This post market study will measure the following:

* Visual Analog Scale
* Programming Parameters

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Willing and able to provide signed and dated informed consent
* Capable of comprehending and consenting in English
* Candidate per labeling for an SCS system as an aid in the management of chronic, intractable pain of the trunk and/or limbs
* Has moderate to severe back and leg pain
* Stable pain medications for back and leg pain for at least 28 days prior to enrollment
* Willing and able to comply with all study procedures and visits
* Willing and able to not increase their pain medications through the 3-Month visit
* Able to differentiate between pain associated with the indication for SCS implant and other types of pain

Exclusion Criteria:

* Previously trialed or implanted with a stimulator or intrathecal drug delivery system
* Expected to be inaccessible for follow-up
* Current diagnosis of moderate to severe central lumbar spinal stenosis with symptomatic neurogenic claudication
* Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results
* If female, is pregnant or is of child-bearing potential and unwilling to use a medically acceptable form of birth control during the study
* Has untreated major psychiatric comorbidity
* Serious drug-related behavioral issues
* Unable to achieve supine or prone position
* Classified as vulnerable or requires a legally authorized representative (LAR)
'Activity Pacing' in PLWH With Fatigue Symptoms.

Physical activity helps to improve health and prevent chronic diseases. However, the fatigue usually hampers the training and execution of physical exercises, especially in people with chronic fatigue syndromes (CFCs), such as persons living with HIV (PLWH). We hypothesize that the "activity pacing", i.e. the strategy to optimize daily physical activity into manageable exercises in a way that should not exacerbate fatigue symptoms, may help a progressive improvement in physical activity of a group of PLWH with fatigue symptoms. Motivation and adherence to exercise will be monitored through the use of digital supports.


Eligibility Criteria:
Inclusion Criteria:

* of age ≥18 years;
* either sedentary or already practicing mild/moderate physical activity (at least 150 minutes of moderate-intensity physical activity throughout the week);
* able to sign the informed consent.

Exclusion Criteria:

The study will exclude HIV+ individuals:

* with any HIV-related disease requiring hospitalization in the 6 weeks before enrolment;
* with medical conditions (e.g. neurologic, muscular-skeletal, cardiovascular diseases) contraindicating non agonistic exercise, as established by a sport medicine specialist;
* currently abusing of substance or alcohol;
* already performing physical activity at higher level than the current WHO recommendations (30 minutes of moderate activity 5 times a week).
Safety and Efficacy of Juvederm® VOLUMA™ for Correction of Mid-face Volume Deficiency

This is a prospective, open-label experience study to be conducted at 6 clinical sites in Australia, with the objective to collect efficacy and safety information for Juvederm® VOLUMA™ when used for volumising the mid-face and cheek area.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with mild to severe mid-face and cheek volume deficit due to age-related changes, who are likely to improve by at least 2 grades following treatment with the study compound, based on a study-specific scale, as assessed by the study physician

Exclusion Criteria:

* Subjects who have a pre-existing medical condition or who have received any treatments or procedures which may impact on the assessment of the effects of the study compound.
* Subjects with a history of allergies or other side effects to dermal fillers, lidocaine, hyaluronic acid or other component of the study compound.
* Subjects were are pregnant or breast-feeding or who are of child-bearing potential and who are not prepared to practice an adequate form of contraception during the course of the study
* Subjects with a history of alcoholism or drug abuse or dependence
Renal Tubular Disorders in Egyptian Children

Renal tubules play an important role in fluid, electrolyte, and acid-base homeostasis. Defect of these functions can give rise to a host of disorders. These disorders can lead to life threatening disturbances in electrolytes and acid-base balance. In Egypt, there is little data about these disorders. Many of these cases are diagnosed late, therefore Early suspicion for diagnosis can improve the overall clinical outcome of these children.

Renal tubules play an important role in fluid, electrolyte, and acid-base homeostasis. Defect of these functions can give rise to a host of disorders. These disorders can lead to life threatening disturbances in electrolytes and acid-base balance. In Egypt, there is little data about these disorders. Many of these cases are diagnosed late, therefore Early suspicion for diagnosis can improve the overall clinical outcome of these children. As a result, starting management early will help those children have a better life. Therefore awareness about these disorders and long-term outcome is really important. The investigators present the clinical characterizations of many tubular disorder and the follow up in our center.

The aim of this study is to reveal the different clinical presentations and the main lab features of renal tubular disorders in children to promote early recognition and management.

Eligibility Criteria:
Inclusion Criteria:

* All children aged from one month to 18 years who have renal tubular disorders.

Exclusion Criteria:

* Children who have renal tubular disorders secondary to drugs, intoxication, obstructive uropathy or transient in nature.
Effect of Prehabilitation During the Conversion Therapy on Postoperative Outcomes in Unresectable Hepatocellular Carcinoma

This is a prospective, randomised controlled clinical trial to study the impact of prehabilitation on postoperative complications, physical function, quality of life, and short-term survival outcomes in patients with unresectable liver cancer undergoing conversion therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Patients must be aged between 18 and 75 years, inclusive, with no gender restrictions.
2. Patients must have an initial diagnosis of unresectable hepatocellular carcinoma (HCC) confirmed by EASL/AASLD diagnostic criteria, pathological histology, or cytology, and must be planned for conversion therapy.
3. Patients must have an American Society of Anesthesiologists (ASA) physical status classification of ≤III.
4. Patients must be physically capable of participating in exercise training, defined as the ability to walk continuously on flat ground for more than 200 meters without rest and to climb two flights of stairs consecutively without requiring a break.
5. Patients must not have any psychiatric disorders, speech impediments, or consciousness disturbances, and must possess adequate comprehension, communication, and literacy skills.
6. Patients must voluntarily enroll in the study, be able to provide written informed consent, and be capable of understanding and adhering to the trial protocol and follow-up procedures.

   -

Exclusion Criteria:

1. A known diagnosis of cholangiocarcinoma, sarcomatoid hepatocellular carcinoma (HCC), combined hepatocellular carcinoma, or fibrolamellar carcinoma.
2. Presence of extrahepatic metastases or concurrent other malignant tumors.
3. Presence of psychiatric disorders or cognitive impairments that would impede compliance with study requirements.
4. Unsuitability for participation in exercise training due to skeletal muscle diseases or a history of fracture within the past 6 months.
5. Pregnant or breastfeeding women.
6. Individuals with severe and irreversible cardiac, pulmonary, or renal organic diseases, or severe anemia, which would make them unsuitable for preoperative rehabilitation programs. -
Wound Etiology and Healing Study

The purpose of the WE-HEAL Study is to help researchers use human tissue samples and health records to study the reasons why some patients heal quickly and some have problems healing wounds. All patients seen with an open wound or hidradenitis suppurativa are invited to participate. Information from this research may help to understand how to prevent and treat certain diseases.


Eligibility Criteria:
Inclusion Criteria:

1. Age \>18
2. Open wound or hidradenitis suppurativa
3. English speaking
4. Able to give informed consent

Exclusion Criteria:

1. Non-English speaking.
2. Unable to give informed consent
A Study of Combivir Plus Abacavir Plus 141W94 in Patients Who Previously Have Used Anti-HIV Drugs

The purpose of this study is to test the effectiveness of Combivir plus abacavir plus 141W94 in patients who previously have used anti-HIV drugs.

In this open-label study antiretroviral-experienced patients receive Combivir (3TC/AZT tablet) plus 1592U89 (abacavir) and 141W94 twice daily for 48 weeks.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* CD4 count greater than 50 cells/mm3.
* HIV RNA less than 50,000 copies/ml.
* No active AIDS (excluding CD4 count less than 200 cells/mm3).
* Ability to comply with dosing schedule and protocol evaluations.

Prior Medication:

Allowed:

AZT or non-nucleoside reverse transcriptase inhibitors (NNRTIs).

Exclusion Criteria

Co-existing Condition:

Patients with any of the following symptoms or conditions are excluded:

* Active AIDS (not excluding CD4 count less than 200).
* Malabsorption syndrome affecting drug absorption.
* Serious medical condition that would compromise safety of the patient.

Concurrent Medication:

Excluded:

* AZT or NNRTIs.
* More than 1 week treatment with any protease inhibitor.
* Enrollment in any other investigational drug protocol.

Patients with the following prior conditions are excluded:

History of clinically relevant pancreatitis or hepatitis within the past 6 months.

Required:

Antiretroviral therapy with either single or double reverse transcriptase inhibitors.
Parecoxib vs. Dexketoprofen for the Management of Pain After Cesarean Section.

Although it is known that parecoxib and dexketoprofen are commonly used in successful post-operative pain relief, there are very few studies that compare these two agents in their individual applications and/or combined with neuraxial analgesia with opioids and even less in post-cesarean section pain, as well as the evaluation of the side effects and their impact on the patient's functionality. For this reason, in order to approach this answer, we sought to perform this study in patients undergoing elective or emergency cesarean section in our institution, who meet the inclusion criteria, using the Visual Analog Pain Scale at 12 hrs and 24 hrs post surgery and evaluating the aforementioned side effects, comparing in one arm of the study Parecoxib + acetaminophen vs Dexketoprofen + acetaminophen in the other arm, randomizing the patients in both groups using a double-blind configuration.


Eligibility Criteria:
Inclusion Criteria:

* Pregnancy 32w or more.
* Emergency or elective caesarean section.

Exclusion Criteria:

* Allergy to Parecoxib.
* Allergy to dexketoprofen.
* Allergy to acetaminophen.
* General anesthesia.
Metabolically Healthy Obesity: Correlations Between BMI and Metabolic Syndrome Biomarkers

The study team's research fills the gap in the obesity literature where BMI with a cut point of 35 is frequently used to show the association between BMI and metabolic syndrome biomarkers. The study team was unable to locate any papers that showed the association between metabolic syndrome biomarkers and BMI from 35 to 69.9, and especially graphically as this clinical team has presented.

A positive association between BMI and metabolic health risk is often presented graphically as a J-shaped curve with BMI on the x-axis and the biomarker of interest on the y-axis. However, BMI is frequently presented in the literature with a cut point of 35 on the x-axis, leading to the assumption that the steep association continues beyond a BMI of 35. This presentation does not capture the metabolically healthy individual with obesity.

In the population of men and women with class II and II obesity who the clinical team studied, it was examined that the association between BMI as a continuous variable from 35 to 69.9 and metabolic syndrome biomarkers (total-, low density, and high density cholesterol, triglycerides, systolic and diastolic blood pressure, fasting blood glucose, and glycosylated hemoglobin), the study team found no evidence for a positive correlation between BMI and TC, LDL-C, TG, and FBG. And while the study team did find positive and significant correlations between BMI and HDL-C, SBP, DBP, and HgbA1C, the effect sizes were small and arguably clinically insignificant.

The study team's research fills the gap in the obesity literature where BMI with a cut point of 35 is frequently used to show the association between BMI and metabolic syndrome biomarkers. The clinical team was unable to locate any papers that showed the association between metabolic syndrome biomarkers and BMI from 35 to 69.9, and especially graphically as this clinical team has presented.

Eligibility Criteria:
Inclusion Criteria:

* BMI in the range of 35 - 69.9
* Men and Women over age 25
Remote Collection of Patient Reported Toxicity Using SMS Text Messaging (CareSignal)

CareSignal has developed an application that allows for remote collection of patient-reported data such as symptoms or outcomes on any device compatible with the short message service (SMS), otherwise known as "text messaging". The software can be configured to complete symptom monitoring by surveying patients about toxicity using the PRO-CTCAE tools. PRO-CTCAE is the patient reported outcomes version of the CTCAE that was designed by the National Cancer Institute (NCI) for use in clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* Currently planning to receive radiotherapy for 2 or more fractions with or without chemotherapy.
* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
* Age 18 years or older.

Exclusion Criteria:

-Unable to reliably access and use a device compatible with CareSignal software.
Repetitive Transcranial Magnetic Stimulation in the Treatment of Obsessive Compulsive Disorders

Objectives.-Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive stimulation methods that became widely used as therapeutic tools in neuropsychiatric research. The aim of this study is to Evaluate the therapeutic impact of different frequencies of repetitive transcranial stimulation (1HZ, 10HZ) in OCD patients. Material and Methods; Forty five patients of OCD were participated in the study. All patients fulfilled the diagnostic criteria of DSM-IV-TR. The mean age of the patients was 27.1+4.5 years. Each patient was subjected to the following: Yale-Brown obsessive compulsive scale (Y-BOCS), Hamilton Anxiety Rating Scale (HAM-A), and Clinical Global Impression - Severity scale (CGI-S). The patients were randomly classified into three equal groups using closed envelop: 1st group received 1 Hz rTMS at 100% of the RMT, 2nd group received 10 Hz rTMS with intensity of 100% of the RMT and 3rd group was sham group received the sham stimulation with a total 2000 pulses every day for each group for 10 sessions. Follow up of the patients using the same previous scales after the end of sessions and 3 months later.


Eligibility Criteria:
Inclusion Criteria:

* All patients fulfilled the diagnostic criteria of DSM-IV-TR

Exclusion Criteria:

* Patients with comorbid psychiatric disorder .
Study to Evaluate the Effect of Sorbion Sachet S Wound Dressing

This is a clinical study to evaluate the effects of sorbion sachet s wound dressing on soft tissue edema and wound bioburden in moderately to highly exuding pressure ulcers.

This study is aimed at the participation of subject with moderately to highly exuding pressure ulcers. Each Subject is expected to participate for a period of 4 weeks or until reepithelization, which occurs first.

Eligibility Criteria:
Inclusion Criteria:

* Subject \> 18 years.
* Subject is attending SW Wound Care Center
* Subject has a wound not smaller than 1cm2
* Subject has a wound not larger than 14cm X 23cm
* Subject has a moderately to highly exudative pressure ulcer that would be indicated for treatment with sorbion sachet S
* Subject or subject's legally authorized representative is informed about the trial, understands the nature of the study and provides written informed consent prior to study enrollment.
* Subject is willing and able to comply with all specified care and visit requirements.

Exclusion Criteria:

* Subject has a lesion that does not meet the inclusion criteria.
* Subject has a pressure ulcer that contains areas of undermined tissue.
* Subject refuses to participate in the study.
* Subject is participating in another clinical study.
* Subject already participates in this study with one wound (only one wound per subject is allowed)
* Subject has known sensitivity to the trial product or any of its compounds.
* Subject is expected to be non-compliant.
* Subject uses therapy known to be immunocompromising such as systemic anti cancer drugs and/or systemic corticosteroids.
* Subject suffers from systemic infectious disease(s) known to negatively influence wound healing, such as AIDS.
* Subject's lesion is a primary skin cancer.
* Subject's lesion is the manifestation of a metastasis.
* Subject is pregnant.
Imaging Lymphatic/Cerebrospinal Fluid (CSF) Drainage From the Head and Neck in Persons With Traumatic Brain Injury: Demonstration of Feasibility and Evaluation of Manual Therapy to Improve Drainage and Facilitate Cognitive Recovery

The purpose of this study is to determine whether a course of daily manual lymphatic drainage over the course of 5 days can improve lymphatic drainage function and cognitive outcomes and to determine whether single sessions of manual lymphatic drainage improves lymphatic drainage in moderate to severe traumatic brain injury (TBI) patients.


Eligibility Criteria:
Inclusion Criteria:

* Female participants must complete the Female Enrollment Form. Those subjects of childbearing potential must have a negative urine pregnancy within 36 hours of study drug administration and also agree to use one of the medically accepted methods of contraception listed on the form for a period of one month following the study. Female subjects of non-childbearing potential, defined as physiologically incapable of becoming pregnant, must meet the criteria listed on the Female Enrollment form, but are not restricted to the use of contraception following study participation.
* Participants must be able to sit upright for periods of 30 minutes.
* Participants should have a body mass index between 19 and 30 kg/m2
* Initial post-resuscitation Glasgow Coma Scale score following blunt head trauma of 3 to 12 or coma (not due to sedation) greater than 6 hours. Emergence from Post-traumatic Amnesia as documented by serial administration of the Orientation-Log or Galveston Orientation and Amnesia Test
* Have an anticipated hospital length of stay of 5 days or more following screening and consent.
* Able to provide consent.

Exclusion Criteria:

* Women who are pregnant or breast-feeding
* Persons who are known to be allergic to iodine
* Persons who have extensive soft tissue damage to the neck region, including carotid artery dissection, spinal cord injury, or other conditions, that makes lymphatic drainage techniques undesirable.
* Women who are of child bearing potential who do not agree to use medically acceptable contraceptives for one month following the study.
* Subjects who are participating in another interventional trial.
Respiratory Muscle Endurance Training in Healthy Elderly

Prevalence of hypertension in the elderly is high. Given that hypertension is the leading cause of cardiovascular disease worldwide, safe and efficacious treatment options for this condition are highly desired. Apart from medication, changes in lifestyle are recommended to lower blood pressure, such as an increase in physical exercise. However, whole-body exercise is not feasible for all. Mobility disabilities, for example, increase sharply with age and are already common in middle age. For this population, it is necessary to have alternative, non-invasive interventions with similar effects on blood pressure. One such intervention might be respiratory muscle endurance training (RMET), but the effects on blood pressure are currently unknown.

The primary aim of this project is therefore to investigate the effects of RMET over the course of several weeks on resting blood pressure in healthy elderly. The secondary aim of the project is to evaluate the effects of RMET on uphill exercise performance in healthy active elderly given that elderly experience structural and functional changes of the lungs potentially affecting exercise performance. Finally, since prevalence of subjective sleep complaints is also high in the elderly, the present study will also investigate the effects of RMET on sleep quality.


Eligibility Criteria:
Inclusion Criteria:

* Age: 55-80 years
* Active (according to World Health Organisation Criteria)
* Systolic blood pressure lower than 140 mmHg and diastolic blood pressure lower than 90 mmHg
* Non-smoking
* Body-Mass-Index (BMI): 18.5-29.9 kg·m-2
* Normal lung function

Exclusion Criteria:

* Known or suspected non-compliance, drug or alcohol abuse
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Previous enrolment into the current study
* Enrolment of the investigator, his/her family members, employees and other dependent persons
* Intake of blood pressure medication or history of hypertension
* Intake of medications affecting sleep or the performance of the respiratory, cardiovascular or neuromuscular system
* Acute illness or chronic conditions affecting sleep or the performance of the respiratory, cardiovascular or neuromuscular system
A Study to Evaluate the Impact of Pre-procedural Intracoronary Nicorandil Injection to PREVENT ReductioN of DecREased TIMI FLOW in Patients Who Undergoing Percutaneous Coronary Intervention for the Coronary Artery Disease

The aim of this study was to determine the effect of intra-coronary administration of nicorandil on the prevention of lowering of coronary blood flow for high-risk plaque lesions defined as the high value of lipid core burden index in patients with coronary artery disease who require stent treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Over 19 years old
2. Patients who agree to the study plan and clinical follow-up plan, voluntarily decide to participate in this study, and consent in writing to the consent to use information
3. Patients who underwent NIRS-IVUS guided coronary stent surgery for coronary artery disease

Exclusion Criteria:

1. Patients with TIMI ≤ 2 before coronary intervention
2. Subjects with known hypersensitivity or contraindications to the following drugs or substances: heparin, aspirin, clopidogrel, ticagrelor, prasugrel, rosuvastatin, ezetimibe, evolocumab, lansoprazole, cobalt chromium, stainless steel nickel And contrast agents (however, even a subject who is hypersensitive to contrast agents can register if they can be controlled by steroids and pheniramine, except for known anaphylaxis.)
3. Pregnant women, lactating women, or women of childbearing age who plan to become pregnant during this study
4. Subjects who plan to have surgery to stop antiplatelet drugs within 6 months from registration
5. Those whose surviving life is expected to be less than 1 year
6. Subjects who visited the hospital due to cardiogenic shock and are predicted to have low survival probability based on medical judgment