cyrilzakka/clinical-trials huggingface dataset:
Offset Mechanisms in Evaluation of Lumbar Medial Branch Blocks

This study examines the relationship between central nervous system (CNS) mechanisms of pain inhibition and the pain relief that occurs following a lumbar medial branch block (MBB).

This study examines the relationship between central nervous system (CNS) mechanisms of pain inhibition and the pain relief that occurs following a commonly-performed nerve block used to diagnose and treat chronic low back pain. Patients scheduled for lumbar medial branch blocks as part of routine clinical care will arrive to clinic prior to the block for quantitative sensory testing procedures that measure CNS pain modulation. Patients will then undergo treatment as usual with their block, subsequently reporting low back pain intensity in a pain diary.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for lumbar MBB in UPMC Pain Management clinics
* Age \> 18 years old
* Predominantly axial chronic low back pain at least 3 months on a daily basis
* Must meet the minimum criteria for cognitive function using the PROMIS 2-item cognitive screener (\>3)
* Low back pain intensity of \> 3/10
* Willing and able to receive study-related phone calls

Exclusion Criteria:

* History of spine surgery at the level of the lumbar MBB
* Active worker's compensation or litigation claims
* New pain and/or psychiatric treatments within 2 weeks of enrollment
* Not fluent in English and/or not able to complete the questionnaires
* Any clinically unstable systemic illness that is judged to interfere with the study
Analysis of Lung Sounds Collected by RESP Biosensor to Support Decision Making in Monitored Hospitalized Pediatric Patients

This observational clinical trial is designed to confirm whether RESP™ Biosensor could be deployed to support clinical decision making in challenging pediatric cases, minimize clinician-to-clinician variability in lung sound interpretation, obviate the need to disrupt change of shift or chart rounds with physicians, and create a durable archive of the patient's lung sounds for longitudinal comparison within or across hospitalizations.


Eligibility Criteria:
Inclusion Criteria:

1. Children between the ages of 4 and 17 with documented physician-diagnosed respiratory disease including infection such as RSV or COVID
2. Hospitalization projected for at least 24 hours after device placement
3. Patient and parent/guardian able and willing to provide informed consent/assent.

Exclusion Criteria:

1. Patient and parent/guardian unable or unwilling to provide informed consent
2. Patient expected to undergo prolonged invasive radiology procedure(s)
3. Plan for discharge within 24 hours
4. Patient expected to undergo major thoracic surgery
5. History of adverse reaction or allergy to TegaDerm ® or similar product
Study of the Cabochon System for Improvement in the Appearance of Cellulite

The purpose of this study is to evaluate the safety and effectiveness of the Cabochon System for the improvement in the appearance of cellulite.


Eligibility Criteria:
Inclusion Criteria:

* Female, age 18-55
* moderate or severe cellulite
* BMI less than 35
* will not to try any other cellulite treatments through 12M follow-up

Exclusion Criteria:

* cellulite treatment on the thighs or buttocks in the last 90 days
* prior liposuction in the thighs or buttocks
* Greater than 10% increase or decrease in body weight within past 6 months
* evidence of active infection or a fever \>38C
* current or recent smoker
* history of hypertension, diabetes or hypoglycemia
* history of coagulopathy(ies) and/or on anticoagulant medication
* history of cardiopathy or pneumopathy
* history of severe anemia
* has atrophic scars, or has a history of atrophic scars or keloids
* taken within 14 days of treatment:

  * NSAIDs (e.g. aspirin, ibuprofen, naproxen)
  * Vitamin E, dietary supplements (e.g. Gingko Biloba, willow bark)
  * Herbal Teas
* Subject is pregnant or lactating

For Extended Follow-Up the following apply:

Inclusion Criteria:

* Subject was enrolled and treated in the CP-01-1004 study - Pivotal Study of the Cabochon System for Improvement in the Appearance of Cellulite
* Subject understands and accepts the obligation not to try or receive any other cellulite treatments through 3 year follow-up

Exclusion Criteria:

* Subject has undergone an injected drug, energy-based device, minimally-invasive or invasive procedure for contouring or cellulite on the buttocks or thighs since their 12 month study follow-up visit.
* Subject has used skin care products (e.g. creams) for improvement in cellulite within 1 month prior to the follow-up visit.
Arthroscopically Assisted Versus Open Surgical Reduction of the Hip in Patients With Irreducible DDH Before the Walking Age

To determine the role of arthroscopy in treatment of the DDH.

* The term developmental dysplasia of the hip (DDH) is composed of a spectrum of pathologies from stable acetabular dysplasia (femoral head centered in acetabulum but acetabulum is shallow) to concentric hips that are unstable (femoral head can be moved in and out of the confines of the acetabulum) and frankly dislocated hips in which there is a complete loss of contact between the femoral head and acetabulum.
* Open reduction , traditionally through a Smith - Peterson approach should be considered only if closed reduction cannot be performed.
* Medial open surgical reduction is a choice for the management of patients younger than 18 months with DDH. The minimal incision and minimal blood loss are advantages of this approach. Limited exposure of the hip joint is a disadvantage.
* The arthroscopic procedure was reported to represent a meaningful alternative to the open procedure due to a lower complication rate, a safe setting, a lower rate of residual dysplasia, no observed redislocation and low rate occurrence of osteonecrosis.
* All the intra-articular structures (hypertrophic ligamentum teres, transverse acetabular ligament, and pulvinar tissue) in the acetabulum that impede the reduction of the femoral head could be eliminated by using the arthroscopic technique.

Eligibility Criteria:
* Inclusion Criteria:
* Age: - from nine months to 18 months.
* Irreducible Hip Dislocation.
* Exclusion Criteria:
* Patient age: below 9 months or above 18 months.
* Teratologic hip dislocation
Gamification of Neurorehabilitation-centric Hand Exercises Post Stroke or Brain Injury

Stroke is the leading cause of adult disability worldwide. Often, severe neurological deficits occur after a stroke and roughly 70% of all stroke survivors have some form of hand function disability. To improve the lives of those with hand function disability, IRegained Inc. has created the MyHandTM System. The MyHandTM System is a smart-mechatronic device programmed with proprietary hand function training regiments (protocols) based on deep research in neuroplasticity. It provides a highly unique and targeted approach to hand function rehabilitation with the help of the aforementioned protocols delivered with gamified training techniques. The gamified format of the protocols allows for better patient engagement, thus allowing for more effective and efficient therapy. Individuals who have sustained a stroke 5 months or earlier (considered to be chronic stroke survivors) will be eligible to participate in this study. Participants will undergo a 2-hour training session, 2-3 days per week, over 12 weeks, for a total of 30 sessions. Hand function therapy will be administered in a specific and gamified manner to enhance rehabilitation of the hand and provide participants with greater opportunity to regain hand function over the course of the study. The goal of this research project is to understand how a gamified approach to hand function rehabilitation impacts engagement and motivation. This understanding will directly translate into the development of more efficient and effective modes of therapy.


Eligibility Criteria:
Inclusion Criteria:

* Sustained a single stroke

Exclusion Criteria:

* Severe spasticity or contractures (2 or less in the CMSA) or any other musculoskeletal or neuromuscular disorders that compromise sensation or other neuromuscular parameters will be excluded from the study. Prospective participants who are incapable of providing consent to participate in the research study will also be excluded (determined by an MMSE score of 23 or less).
Pain After Intravitreal Therapy

This randomized clinical trial is comparing two different needles (27 gauge versus 30 gauge) for intravitreal therapy (IVT). Standardized questionnaires and pain scales should allow for standard recommendation regarding the optimal needle size for IVT.

Purpose: To evaluate the influence of the type of the needle on pain scores after intravitreal therapy (IVT).

Design: Randomized clinical trial Methods: A total of 200 patients, treated with an IVT for exudative age-related macular degeneration (AMD) or a vascular retinal disease, will be included and randomly assigned to be treated with either a 27-gauge needle (group 1) or a 30-gauge needle (group 2). After IVt the patient has to fill out a standardized questionnaire including pain scores on the visual analog scale after the surgical procedure.

Regression analysis of the scaled questionnaires should allow for a standard recommendation regarding the optimal needle size for minimal subjective pain during IVT.

Eligibility Criteria:
Inclusion Criteria:

* vitrearetinal disease including age-related macular degeneration,
* clinical significant macular edema due to diabetic retinopathy or other vascular disorders
* treatment with intravitreal therapy

Exclusion Criteria:

* missing informed consent
* age under 50 years
Breaking of Sitting Time Prevents Lower Leg Swelling

Sitting or standing during a prolonged and uninterrupted period of time is related to negative health outcomes, such as lower extremity swelling. It is unknown if interrupting sedentary behavior by including brief bouts of standing up to the sitting time can attenuate lower leg swelling. Thus, our purpose is to examine if breaking sitting time by adding sit-to-stand transitions attenuates or even prevents lower leg swelling, compared with uninterrupted motionless standing and uninterrupted motionless sitting, using localized bioelectrical impedance raw parameters.

Increased sedentary behavior has deleterious effects on cognitive function, mental health, physical function, disability as well as quality-of-life. Nowadays, prolonged sitting time has been introduced into many situations such as transportation and in the workplace. Staying in the same position (e.g., sitting/standing) for a long and uninterrupted period is associated with poorer health-outcomes, increasing the risk for premature mortality. For instance, sitting for a long period of time has been associated with lower limbs edema. This condition causes discomfort and pain, in turn associated with a lower quality-of-life.

The literature shows that interruption of prolonged sitting time has a positive impact in several health-related risk factors. However, no studies analyzed the effects of motionless sitting with brief standing bouts on lower leg swelling. Thus, the aim of this study is to examine and to compare the effects of standing, sitting and sit-to-stand transitions on lower leg swelling using localized bioelectrical impedance analysis (BIA) measurements A crossover randomized experiment was performed among 20 healthy individuals \[age: 27.5±5.9y, 47% females\]. In this study, the participants performed the 3 conditions (randomly ordered): 1) uninterrupted motionless standing; 2) uninterrupted motionless sitting; 3) sit-to-stand transitions (1 minute sitting followed by 1 minute standing). Before each condition, a 10-min resting period was performed. Total fat and fat-free mass were determined by dual-energy x-ray absorptiometry. Localized resistance (R), reactance (Xc), impedance (Z) and phase angle (PhA) were assessed at the baseline, at 10 min and at 20 min for each condition.

The researchers hypothesized that interrupting a prolonged sitting position with sit-to-stand transitions will result in greater muscle pump, preventing lower leg swelling.

Eligibility Criteria:
Inclusion Criteria:

* BMI ranging between 18.5 to 29.9 kg/m2;
* Not taking any medications at the time of the measurements;
* All women should have a (self-reported) regular menstrual cycle.

Exclusion Criteria:

* Self-reported inability to stand for 20min without moving the lower limbs
* An active smoking status
* Presence of diabetes
Delayed Diagnosis of Bacteriologically Positive Pulmonary Tuberculosis and Relative Optimized Suggestions in China

The purpose of the study is to collect health-seeking pathways, sociodemographic characteristics and symptoms of 400 newly diagnosed patients with bacteriologically confirmed pulmonary tuberculosis(TB).

This research is a retrospective, multicenter, case-control study. The purpose of this study is to collect and assess health-seeking pathways, sociodemographic characteristics and symptoms of 400 newly diagnosed patients with bacteriologically confirmed pulmonary tuberculosis(TB).

According to inclusion criteria and exclusion criteria, a total of 400 participants with bacteriologically confirmed TB will be recruited and acquired their health-seeking pathways in different clinical institutions of pulmonary tuberculosis. Totally, 20 TB-designated medical institutions will be conducted in depth, covering the eastern region (7), the central region (8) and the western region (5), each hospital will enroll 20 eligible patients on the basis of convenience.

The cohorts are divided into delayed diagnosis and undelayed diagnosis. The former is defined if The length from the first clinical visit date to the diagnosis confirmed date is more than 14 days. Diagnosis is confirmed by any positive result of anti fast bacteria smear, culture, histological test, and molecular detection such as GeneXpert. By offline or online interview, we aim to collect basic sociodemographic characteristics, symptoms, health-seeking pathway, including: hospital name, the date of each visit, laboratory tests and radiology evaluation results, diagnosis, treatment, medical and transportation costs. Then list the hospitals of previous consultations and trace their classification through the official website of the Health and Medical Commission. Determine whether these hospital are designated institution based on the CDC's publicity. Consult the laboratory facilities by phone.

The primary objective is to gain the median time of pulmonary tuberculosis diagnosis confirmed and the correlation between the classification of the first-visit-institution and the diagnosis delay of the pulmonary tuberculosis.

The secondary objective is to gain the bacteriology examination coverage rate: anti fast bacteria smear, tuberculosis culture, and GeneXpert; the correlation between the use of fluoroquinolones as anti-infection treatment before tuberculosis diagnosis confirmed and the diagnosis delay of the pulmonary tuberculosis; the sociodemographic characteristics of patients with or without pulmonary tuberculosis diagnosis delay; The rates of onset symptoms and its correlation to diagnosis delayed of pulmonary tuberculosis diagnosis confirmed patients.

Eligibility Criteria:
Inclusion Criteria:

* Bacteriological positive: including positive AFB smear/ culture / molecular test;
* Agree to accept this survey;

Exclusion Criteria:

* HIV antibody positive and AIDS patients;
* Combined with extrapulmonary TB;
* Critically ill patients, and according to the judgment of the research physician, it is impossible to survive for more than 16 weeks;
Effect of NMN Supplementation on Organ System Biology

The goal of this proposal is to determine whether the beneficial effects of NMN on metabolic function observed in rodents applies to people.

This study is looking at the effect of the dietary supplement "Nicotinamide mononucleotide" (NMN) on key cardiovascular and metabolic functions, specifically those that are important risk factors for diabetes and cardiovascular disease.

Eligibility Criteria:
Inclusion Criteria:

* BMI 25.0-50.0 kg/m²
* Prediabetes defined as fasting plasma glucose of ≥100 mg/dL, or HbA1C ≥5.7, or HOMA-IR ≥2.5.

Exclusion Criteria:

* Women who are still having menses
* Persons who take niacin, nicotinamide, or other vitamin B3-related supplementation and are not willing to discontinue supplementation for 3 weeks before medical screening and during the entire study period
* Persons who consume moderate-large amounts of caffeine daily (\>2 cups of coffee or 8 oz caffeinated drinks per day) or consume less amounts of caffeine but believe withdrawal symptoms (e.g. headache) are likely if caffeine is stopped
* Unstable weight (\>3% change during the last 2 months before entering the study)
Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation

This is a Phase IV, randomized, double-blind, comparative study of the use of two preparations of ethinyl estradiol and cyproterone acetate in the treatment of menstrual irregularities of hyper-androgenic origin.


Eligibility Criteria:
Inclusion Criteria:

* Female subject
* Premenopausal subject
* 18 years or older
* Medical history of irregular menses lasting at least 3 months
* Signature of informed consent

Exclusion Criteria:

* Pregnancy
* Use of hormonal contraceptives within 3 months of screening
* Primary bilateral oophorectomy
* Chemotherapy and / or radiotherapy within 6 months of screening
* Hysterectomy
* Myotonic dystrophy
* Galactosemia
* Galactorrhea
* History of tuberculosis or schistosomiasis
* Elevated prolactin / other significant laboratory alterations
* Diabetes
* Premature ovarian deficiency
* Sensitivity to any component of the drug formula
Lifestyle Intervention for Treating Systemic Hypertension in Primary Care Setting

The Canadian hypertension education program recommends increased physical activity, adoption of the Dietary Approaches to Stop Hypertension (DASH) diet, and reduction in sodium and alcohol intake for treatment and prevention of hypertension. Objective: To describe patients participating in an interdisciplinary lifestyle intervention to reduce blood pressure in a family medicine primary care setting. Design: Descriptive study. Participants: The study aims to recruit 60 sedentary hypertensive patients to participate in a 6-month randomized-controlled trial. To be eligible, patients must be ≥18 years of age, sedentary (7-day measured steps/day and self-report), hypertensive (based on 24-h ambulatory blood pressure measurements \[ABPM\]), non-smoker, non-diabetic and without dyslipidemia. Intervention: Patients are recruited by health care professionals of the family medicine unit and are thereafter randomized to one of four intervention groups: 1) standard medical care (control), 2) improved diet (DASH diet), 3) physical activity, or 4) both improved diet and physical activity. Patients are evaluated (pre, mid and post intervention), monitored, and educated by the interdisciplinary health care team that includes a physician, a kinesiologist, a nutritionist and a nurse, depending on the intervention group. T-tests and descriptive statistics were used to analyse data. This study will document the efficacy of a primary care lifestyle intervention program on cardiometabolic and hypertension risk factors.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Sedentary (7-day measured steps/day and self-report)
* Arterial hypertensive (based on 24-h ambulatory blood pressure measurements \[ABPM\])

Exclusion Criteria:

* secondary hypertension
* diabetes
* dyslipidemia
* cardiovascular diseases with complications
* smoker
Exploratory Study of ZG-801 for the Treatment of Hyperkalemia

To investigate the efficacy of each ZG-801 starting dose and the titration algorithm of ZG-801 for the treatment of hyperkalemia in Japanese patients.

To evaluate the safety of ZG-801 for the chronic use (total over 52 weeks). In addition, to confirm the safety after the discontinuation of ZG-801 treatment on 1 week follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Males and females ages 18 - 80
* Informed consent given
* Serum Potassium measurement at baseline is 5.1 to \< 6.5 mEq/L (Non-dialysis patients or 5.5 to \< 6.5 mEq/L (Dialysis patients)

Exclusion Criteria:

* Subjects with hospitalization for hyper- or hypoglycemia with Type 2 diabetes or for acute exacerbations of heart failure within the previous 3 months
* Subjects with severe heart failure, defined as NYHA (New York Heart Association) class IV
* Subjects with uncorrected hemodynamically significant primary vascular disease or uncontrolled or hemodynamically unstable arrhythmia
* Subjects with coronary artery bypass graft, percutaneous intervention, or major surgery including thoracic and cardiac, within the previous 3 months or anticipated need during study participation
* Subjects with heart, liver (only Dialysis patients), or kidney transplant recipient, or anticipated need for transplant during the study period
* Subjects with any of the significant cardiovascular or cerebrovascular events within the previous 2 months
* Subjects with a history of or current diagnosis of a severe swallowing disorder, moderate to severe gastroparesis, or history of bariatric surgery, bowel obstruction or severe gastrointestinal disorders or major gastrointestinal surgery
* Subjects who cannot use the oral concomitant medication to be separate 3 hours from ZG-801 medication
* Subjects suspected of transient high potassium levels, such as those caused only by dietary effects
Role of Bandage After FUE Hair Transplantation

The aim of this interventional study is to determine the role of bandage on the follicular donor sites on the scalp after FUE hair transplantation.

A randomized side of the scalp will be covered using bandage, the other side will be left naked. Subjects under study will be evaluated after the procedure is completed, and day 1 and day 7 post-procedure during the healing phase. This will in turn help, answering the importance of bandage in healing of the donor site post-hair transplantation.

In this modern era, hair-transplantation has become very common. Interests in wound healing is not new; with every passing day, different techniques are introduced to get better results for the patients. The current literature available online shows that many hair-transplant centers have stated about using bandage on the donor area post-transplantation, however, there isn't a single study available to augment this use of bandage. On the other hand, data regarding application of antibiotic ointments and silicon gels is available. The punctures made during FUE are only of 9-10mm, requiring no sutures. In addition to this, the blood supply of the scalp also favors quick healing. The process of re-epithelization starts within a few hours of injury and progresses over the first 1 to 3 days. Most of the clinics remove, the bandage after 24hrs, disrupting the healing process of the skin. In the present study, the investigators sought to compare bandage versus no-Bandage donor site in terms of healing. The investigators hypothesize that, compared with bandage site, no-bandage donor site after FUE will have reduce post-procedural downtime and donor site inflammation ultimately, enhancing patient satisfaction with the procedure. The long-term goal of this study is to get evidence-based usage of bandage, if results are in contrast with the hypothesis.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Able to provide informed consent
* Planning to undergo follicular unit extraction hair restoration

Exclusion Criteria:

* Significant medical or surgical conditions
* Unable to give informed consent
* Immunocompromised