cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate Safety & Efficacy of Topical ATx201 OINTMENT in Adolescents and Adults With Mild to Moderate AD

This is a Phase 2 randomized, double-blind, parallel group, vehicle-controlled study to evaluate the safety and efficacy of topical ATx201 OINTMENT in adolescents and adults with mild to moderate Atopic Dermatitis

This is a Phase 2 randomized, double-blind, parallel group, vehicle-controlled study to evaluate the safety and efficacy of topical ATx201 OINTMENT in adolescents and adults with mild to moderate Atopic Dermatitis.

Approximately 210 subjects will be randomly assigned to receive ATx201 OINTMENT 4%, ATx201 OINTMENT 7%, or OINTMENT vehicle for 6 weeks. Treatments will be balanced into consecutive blocks in 1:1:1 ratio for the active groups and vehicle.

Sixteen additional subjects (adults and adolescents) will be enrolled in a 2-week open label substudy of twice-daily ATx201 OINTMENT 7% to evaluate the PK profile of ATx201.

Eligibility Criteria:
Inclusion Criteria (main ones):

1. Diagnosis of AD using the Hanifin and Rajka criteria and minimum 1-year history with a current IGA score of 2 or 3 and treatable BSA ≥5% but ≤36% (treatable BSA includes all lesions present at screening except scalp)
2. Age ≥12 and \<60 years
3. Male or nonpregnant and nonlactating female who is abstinent or agrees to use effective contraceptive methods throughout the course of the study. Females must have a negative urine beta-human chorionic gonadotropin hormone (hCG) pregnancy test at Day 1.
4. Subject or LAR able to understand and provide signed informed consent. Assent is also required of adolescents.
5. Normally active and otherwise in good health by medical history and physical examination

Exclusion Criteria (main ones):

1. Actively infected AD (ie, requiring antimicrobial therapy as determined by the investigator)
2. Acute exacerbation or flare in the 4 weeks prior to the Day 1 visit that necessitates treatment with a high potency corticosteroid (such as clobetasol propionate or betamethasone dipropionate), or antibiotics, or prednisolone
3. Enrollment in an ATx201 study in the previous 6 months
4. Allergy or history of significant adverse reaction to ATx201 or related compounds, or to any of the excipients used
5. Underlying skin condition that may interfere with the placement of study treatment or impede clinical evaluations (including active Herpes simplex)
6. Current acute or chronic condition unless considered clinically irrelevant and stable by the investigator
7. The presence of a condition the investigator believes would interfere with the ability to provide informed consent or assent, or comply with study instructions, or that might confound the interpretation of the study results or put the subject at undue risk
8. Unable or unwilling to comply with study procedures
9. Exposure to any IP within 30 days prior to randomization

There are also some specific criteria related to prior or concomitant therapy
Effect of Cryotherapy and Laser Application on Post-Operative Pain in Single Visit Endodontically Treated Symptomatic Apical Periodontitis Cases

This study compare the effect of applying ice after single visit endodontic treatment with lasers to reduce post operative pain .

one of the most popular complications after single visit endodontic treatment is pain either spontaneous or on biting so in this study we choose one of the most difficult and challenging cases " Hot tooth " to compare lasers and cryotherapy different applications to reduce post operative pain after single visit endodontic treatment

Eligibility Criteria:
Inclusion Criteria:

* • Vital teeth display symptomatic apical periodontitis (Symptomatic apical periodontitis was determined based on the clinical symptoms of severe preoperative pain (visual analogue scale \[VAS\] \> 60) and severe percussion pain (VAS \> 60).

  * Teeth, with a periapical index score (PAI) of 2 or 3 indicating small changes in bone structure and slight mineral loss respectively.
  * Mobility less than 1 mm in either direction.
  * Absence of periodontal pocket around the tooth.
  * Symptomatic pulpitis with spontaneous pain or lingered by cold or heat.
  * Teeth without pus or inflammatory exudates draining through the canal.
  * Teeth without anatomic variations

Exclusion Criteria:

* • Patient with any systemic disease.

  * Immunocompromised patients.
  * Pregnant or lactating patients.
  * Apparently narrow roots in which apical preparation with the #40 file would be overzealous.
  * Retreatment cases.
  * Necrotic painful teeth with absence of sinus tract for drainage.
  * Patients on analgesics or sedative medication up to 6 hours before treatment
Effects of Tan Tui Exercises on Strength and Performance of Football Players.

Randomized controlled trial (RCT) to investigate the effects of Tan Tui exercises on the strength and performance of football players. Tan Tui can provide football players with a well-rounded approach to physical and mental development, which can contribute to enhanced performance, injury prevention, and personal improvement both on and off the field there is limited study available on the effectiveness of Tan Tui exercises.

Tan Tui training develops mental fortitude, focus, and discipline. Football players can benefit from better concentration, emotional resilience, and the capacity to remain calm under pressure. While football generally focuses on offensive and defensive strategies, mastering Tan Tui self-defense techniques can teach players with real abilities for personal protection off the field. Tan Tui can help with injury prevention by increasing flexibility and body awareness. Tan Tui practitioners are frequently more equipped to avoid strains and sprains. The meditative aspects of Tan Tui training can help football players manage stress and anxiety, improving their mental well-being and overall quality of life.

Eligibility Criteria:
Inclusion Criteria Male Player

* Player of academy from last 1 year
* Aged 18-35 years.
* BMI (19-29)

Exclusion Criteria:

* • Surgical History

  * Fracture History
  * Meniscal pathology
  * Knee injury due to trauma
DCB Versus Primary Selective Stenting in TASC C/D Femoropopliteal Artery Disease

This study aims to compare the mid- and long-term outcomes between paclitaxel-coated balloon and primary selective stenting in the treatment of TASC C/D femoropopliteal artery occlusive disease.


Eligibility Criteria:
Inclusion Criteria:

* Subject age 18-85yrs.
* Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved consent form.
* Subject understands the duration of the study, agrees to attend follow-up visits, and agrees to complete the required testing.
* Rutherford category 2-5.
* Subject has a de novo TASC C/D femoropopliteal artery lesions which does not exceed to the segment P1 of popliteal artery.
* The total length of target lesion ≤30cm.
* Reference vessel diameter \>4 mm and \<6.5 mm by visual assessment.
* Patent inflow artery with stenosis \<30% and at least 1 infrapopliteal artery to the ankle (\<50% diameter stenosis).
* A guidewire has successfully traversed the target treatment segment.

Exclusion Criteria:

* Acute thrombus in the target vessels.
* Vessel stenosis or occlusion due to Buerger's disease or autoimmune arteritis.
* Subject received prior stents implantation with in-stent restenosis or occlusion.
* Reintervention of the target lesion \<90 days before the study procedure.
* Acquired thrombophilia or uncontrolled hypercoagulation states.
* Life expectancy \<12 months.
* Severe renal（SCr≥2.5 mg/dl）or hemodialysis dependence.
* Pregnancy, suspected pregnancy, or breastfeeding during study period.
* Contraindication to contrast media or any study-required medication (antiplatelet, anticoagulant, or thrombolytic agents, etc.).
* Hypersensitivity to nitinol and/or paclitaxel.
Rituximab in Treating Patients Undergoing Donor Peripheral Blood Stem Cell Transplant for Relapsed or Refractory B-cell Lymphoma

This phase II trial studies giving rituximab before and after a donor peripheral blood stem cell transplant in patients with B-cell lymphoma that does not respond to treatment (refractory) or has come back after a period of improvement (relapsed). Monoclonal antibodies, such as rituximab, can interfere with the ability of cancer cells to grow and spread. Giving rituximab before and after a donor peripheral blood stem cell transplant may help stop cancer from coming back and may help keep the patient's immune system from rejecting the donor's stem cells.

PRIMARY OBJECTIVES:

I. To determine the effect of addition of peri-transplant rituximab on relapse rate at 18 months after non-myeloablative allogeneic hematopoietic cell transplant (HCT) for cluster of differentiation (CD)20+ B-cell malignancies.

SECONDARY OBJECTIVES:

I. To determine overall and progression-free survival and non-relapse mortality.

II. To determine the incidence and severity of acute and chronic graft-versus-host disease (GVHD).

III. To determine the rate of graft rejection and graft failure.

IV. To determine the time to engraftment.

V. To determine the incidence of serious adverse events with the addition of rituximab.

VI. To evaluate the pharmacokinetics of rituximab in the setting of non-myeloablative allogeneic HCT.

VII. To describe donor and host polymorphisms of the FC gamma receptor IIIa (FCg RIIIA) and CD32 and evaluate their impact on disease response and relapse.

OUTLINE:

Patients receive rituximab intravenously (IV), pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically for 18 months and then annually for 5 years.

Eligibility Criteria:
Inclusion Criteria:

* With a diagnosis of CD20-expressing B-cell malignancy of any histologic type or grade for whom non-myeloablative allogeneic transplant is considered an appropriate treatment option
* Who are enrolled on a non-myeloablative allogeneic HCT protocol employing total-body irradiation (TBI)-based conditioning of =\< 4.5 Gy, with or without fludarabine; this protocol may be used as an adjunct to the allogeneic arm of a tandem autologous/allogeneic transplant protocol, provided the allogeneic conditioning meets the above criteria
* Receiving unmodified peripheral blood mononuclear cell graft products
* With an appropriate related or unrelated donor; human leukocyte antigen (HLA)-haploidentical donors are excluded
* Able to give informed consent (if \>= 18 years of age), or with a legal guardian capable of giving consent (if \< 18 years of age)

Exclusion Criteria:

* Ineligible for non-myeloablative allogeneic HCT
* Receiving an HLA-haploidentical allograft
* Who are fertile but unwilling to use contraception during and for at least 12 months after HCT
* Females who are pregnant or breast-feeding
Optimizing Ankle Exoskeleton Assistance for Walking Across the Life Span

The investigators seek to determine whether ankle exoskeletons can reduce metabolic energy expenditure during walking for users across the age-spectrum.

Older adults walk with greater metabolic rates than young adults. Growing evidence suggests that the greater older adult metabolic rates are related to the structural properties of their lower leg tissues. The tendons of the leg of older adults are more compliant than that of young adults. Accordingly, older adult leg tendons stretch more under a given load, such as during walking, causing their muscles to operate at shorter, less optimal lengths, and higher activity levels than the muscles of young adults - a less economical way to produces force.

Thus, the investigators seek to examine whether wearing wearable robotic boots (i.e., ankle exoskeletons) could enable muscles to produce force more economically. By adding an exoskeleton in-parallel to the ankle, the investigators hypothesize that older adults will walk with lower whole-body metabolic rate than without the exoskeleton assistance.

In this study, the investigators will have both young and older adult participants walk on a treadmill with a commercially available ankle exoskeleton set in multiple assistance modes. During these trials, the investigators will measure the metabolic cost of walking in young and older adults and also take many physiological and biomechanical measurements to help assess how exoskeletons work to reduce walking effort.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be able to walk for 60 minutes in a 90-minute time frame.
* Subjects are apparently free of cardiovascular, metabolic, and renal disease, which includes no signs or symptoms suggestive of cardiovascular, metabolic or renal disease.
* Subjects have no current musculoskeletal injury.
* Subjects need to be either 18-45 or 65+ years old.

These criteria meet the American College of Sports Medicine's 2015 guidelines for participant health screening prior to joining a moderate or moderate-to-vigorous exercise protocol. (Riebe et al., 2015).

Exclusion Criteria:

* Have dementia or an inability to give informed consent
* Have a musculoskeletal injury or feel pain while walking
* Have a history of dizziness and/or balance problems
* Have cardiovascular, heart, metabolic, or renal disease, or respiratory problems
* Smoke cigarettes
* Asthma
* Feel pain or discomfort in the chest, neck, jaw, arms during rest or exercise
* Have orthopnea or paroxysmal nocturnal dyspnea
* Have ankle edema
* Have palpitations or tachycardia
* Have a heart murmur
* Have had a heart attack
* Have diabetes
* Have a pace maker
* Have unusual shortness of breath with usual activities
* Are \<18 or 46-64 years of age
* Do not speak or understand English
Tivozanib in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Triple Negative Breast Cancer

This is a phase 2 multicenter, double-blind, randomized, placebo-controlled, two-arm study for subjects with locally recurrent or metastatic triple negative breast cancer.

This is a phase 2 multicenter, double-blind, randomized, placebo-controlled, two-arm study for subjects with locally recurrent or metastatic triple negative breast cancer.

Patients will be randomized 2:1 to either tivozanib hydrochloride and weekly paclitaxel or placebo and weekly paclitaxel.

Subjects will be stratified based on Eastern Cooperative Oncology Group (ECOG) performance score (0 vs 1) and line of treatment (first vs second).

All subjects will be evaluated for progression free survival and overall survival as well as safety and tolerability. Biomarker and pharmacokinetic (PK) analysis are also included in study. This study will determine whether tivozanib hydrocholoride combined with weekly paclitaxel improves clinical outcomes in patients with triple negative breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Locally recurrent or metastatic TNBC, defined as ER/PR \<1%, HER2 0-1+, or 2+ with negative FISH
* Measurable disease per RECIST version 1.1
* ECOG performance status of 0 or 1
* Confirmed available archival tumor tissue.

Exclusion Criteria:

* More than 1 prior systemic chemotherapy for treatment of locally recurrent or metastatic breast cancer (neoadjuvant and adjuvant therapy is allowed provided the subject did not progress within 12 months of taxane based therapy
* Prior treatment with VEGF pathway targeted agent
* Major surgery within 4 weeks or minor surgery or radiotherapy within 2 weeks of first dose of study drug
* Known history of central nervous system metastasis (subjects with previously treated (radiotherapy or surgery) brain metastasis that have been stable off steroids or enzyme-inducing antiepileptic drugs for at least 3 months following prior treatment may be enrolled)
* Significant hematologic, gastrointestinal, thromboembolic, vascular, bleeding, or coagulation disorders
* Significant serum chemistry or urinalysis abnormalities
* Significant cardiovascular disease, including: uncontrolled hypertension; myocardial infarction or unstable angina within 6 months prior to administration of first dose of study drug; and symptomatic left ventricular dysfunction or baseline left ventricular ejection fraction (LVEF) by multigated acquisition scan (MUGA) or ECHO.
* Severe peripheral neuropathy ≥ Grade 2
* Currently active second primary malignancy
Intravitreal Injection Site and Perceived Pain

The objective of this study is to explore the perception of pain during intravitreal injection related to the distance of the entry site from the limbus.

In this pilot cross-over study, the investigators aim at exploring a factor not studied yet on the perception of pain during the injection procedure, and that is the distance of the entry site from the limbus.

Study population: Pseudophakic patients needing multiple intravitreal injections. In case of bilateral eligibility, one eye per patient will be included (randomly- based on a random chart).

Intervention: two injections per eye, will be included in the study. All steps of the technique will be similar between the two injections except for the entry site distance from the limbus, which will be 3.5 in one and 4.00 mm in the other. To prevent bias, the first injection entry distance will be randomly selected (based on a randomized chart).

The patient is blind to the entry distance, and a questionnaire with a visual analog pain scale will be given to the patient by a technician (to prevent any bias) to be filled after the injection. The analog pain scale is a scale of numbers from 0 to 10 representing the degree of patient's perceived pain. A score of 0 indicates no perception of pain; a score of 10 indicates a perception of the worst pain possible. The scale is also illustrated with face emojis corresponding to a written description of pain perception from no perception of pain, represented by a green, fully smiling face to perception of the worst pain possible, represented by a red, crying, fully frowning face.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 -100 years
* Diagnosis of diabetic macular edema, age related macular degeneration, or retinal vein occlusion
* Treated with bevacizumab, ranibizumab, aflibercept
* The need for at least two intravitreal injections
* Pseudophakia

Exclusion Criteria:

* Texas Department of Corrections medical records
* Under 18 years-of-age
* First intravitreal injection experience of patient
Role of Matrix Metalloproteinases (MMPs) and Tissue Inhibitors of Metalloproteinases (TIMPs) in Children With Myocarditis

Children can have or develop certain problems with their heart function, specifically with the heart muscle or myocardium. This problem can be caused by many things specifically by infection resulting in myocarditis (inflammation of the heart muscle) or dilated cardiomyopathy (caused by many factors including high blood pressure and heart attacks). The body goes through many processes to repair the injured tissue including using proteins that cause the muscle mass to increase called matrix metalloproteinases (MMPs). The body also uses proteins that direct the MMPs to stop increasing the muscle mass called tissue inhibitory of metalloproteinases (TIMPs). Currently, there are no published studies that explain or evaluate the relationship that MMPs and TIMPs have in myocarditis and dilated cardiomyopathy in children.

The investigator wishes to perform a prospective study of the serum levels of these proteins and their regulators in children with myocarditis and/or dilated cardiomyopathy and compare them with children that have no heart disease.

All children who present with signs and symptoms of myocarditis and have laboratory findings consistent with cardiomyopathy will be eligible. After prospective consent, all subjects will receive: (1) a complete physical examination, (2) complete transthoracic echocardiogram to better characterize the disease process. Follow-up echocardiograms will be performed at 24-72 hours after admission into the protocol and at discharge from the hospital. Approximately 2 teaspoons of blood will be drawn at: (1) enrollment, (2) 24 hours after, (3) 72 hours after, (4) and at hospital discharge. Those subjects that receive a heart transplant will have blood drawn at the time of transplantation. For those that have a cardiac catheterization or have a muscle biopsy as part of their standard of care, will also have a biopsy of their right ventricle performed.

Data to be collected: Minimum patient demographic data (age, sex, ethnic origin), vital signs, clinical course events/data (i.e. need for dialysis, length of stay, surgical time points, etc), diagnostic test results (EKGs, ECHOs, etc), significant medical history data, and standard of care laboratory results.

The investigator wishes to evaluate the relationship of this data with the patient's diagnosis, clinical course, and serum levels of MMP and TIMP proteinases.

Eligibility Criteria:
Inclusion Criteria:

1. Evidence from diagnostic tests and physical exam that confirm inflammatory cardiomyopathy.

Exclusion Criteria:

1. Patients with structural heart disease other than septal defects or patent ductus arteriosus
2. Patients with history of arrhythmia
3. Patients with history of ventricular dysfunction diagnosed by echocardiograms
4. Patients with history of chronic systemic illness
Fascial Manipulation in Patients With Hip Osteoarthritis

The study will test the efficacy of the treatment of soft tissues for osteoarthritis patients that are waiting for total hip arthroplasty. The fascial manipulation provides a deep pressure of specific points of the muscle fascia. The aims of this treatment are the improve of pain before the surgery and the improve of functional performance after the surgery.


Eligibility Criteria:
Inclusion Criteria:

* patients age 40-80, with primary coxarthrosis waiting for total hip arthroplasty that complain a pain measured by Numeric Rating Scale ≥ 5 and that live in Bologna

Exclusion Criteria:

* arthroplasty revision or substitution. Patient with cognitive deficiency and severe comorbidity (rheumatic, neurological or cardiovascular pathology)
Clinical Practice of Inhalation Anesthesia With Sevoflurane in China

Until recently, there was a lack of understanding and consensus among Chinese anesthesiologists how they should practice general anesthesia with volatile anesthetics, since there was no standard of inhalation practice. In August 2011, the Anesthesiology branch of the Chinese Medical Association launched the first version of Chinese Consensus of Standard Clinical Practice for Inhalation Anesthesia (Consensus) in order to standardize the practice in China.

The proposed registry is aimed to evaluate the current inhalation practice one year after the Consensus has been released, and related patient outcome. This registry evaluated sevoflurane anesthesia, including screening, induction, maintenance, emergence, and follow-up within 24 hours post-operation.


Eligibility Criteria:
Inclusion Criteria:

1. Man or woman, aged from 18 to 70 years old.
2. American Society of Anesthesiologists (ASA) physical status: I, II and III.
3. Surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA).
4. The type of surgery is either general surgery, or orthopedics, or gynecology.
5. The duration of anesthesia ranges from 1 to 5 hours.

Exclusion Criteria:

1. History of clinically significant cardiovascular, pulmonary, renal, hepatic or central nervous system or muscle disease.
2. Known hypersensitivity or history of unusual response to any halogenated anesthetics.
3. Personal or familial history of malignant hyperthermia.
4. Female patients who are either pregnant or breast feeding.
5. General anesthesia is administered with total intravenous anesthesia (TIVA) of propofol or sevoflurane maintenance combined with propofol continuous infusion during maintenance.