cyrilzakka/clinical-trials huggingface dataset:
Use of Ultrasonic Bone Scalpel in Adolescent Idiopathic Scoliosis

The primary purpose of this randomized trial is to compare the efficacy of an ultrasonic bone scalpel (or osteotome device) with standard of care surgical instruments during posterior spine fusion with instrumentation.


Eligibility Criteria:
Inclusion Criteria:

1. 10-18 years of age
2. Diagnosis of Adolescent Idiopathic Scoliosis (AIS)
3. Scheduled for a posterior spinal fusion (without Schwab Grade II or higher osteotomy)

Exclusion Criteria:

1. Plan for a posterior column osteotomy of Schwab Grade II or higher
2. Prior spinal surgery
3. Magnetic Resonance Imaging (MRI) abnormalities (such as syrinx and/or chiari malformations)
4. Subjects with medical comorbidities (e.g. heart, lung, kidney disease)
5. Subjects with bleeding diatheses
6. Non-idiopathic etiology for scoliosis
Hyperglycemia and Effects of Daily 100 mg Versus 200 mg of Hydrocortisone Therapy in Patients With Septic Shock

The purpose of this study is to compare hyperglycemia and other effects, include 28-day mortality and time to reversal of shock between 100 milligrams and 200 milligrams of hydrocortisone as initial dosage in patients with septic shock.

The intervention group will be received 100 milligrams per day of hydrocortisone on the first three day the taper off, whereas the control group will be received 200 milligrams per day of hydrocortisone on the first three day the taper off. Hyperglycemia rate will be monitored every 6 hours after hydrocortisone is started until 24 hours after it is stopped.

Also, 28-day mortality will be follow after hydrocortisone is started.

Eligibility Criteria:
Inclusion Criteria:

* Septic shock
* Adequate fluid resuscitation and vasopressor therapy are unable to maintain hemodynamic stability

Exclusion Criteria:

* Receive systemic steroid in past 3 months
* Established adrenal insufficiency
* Currently used in chemotherapy or immunosuppressive agents
* Radiotherapy currently received
* Known HIV infection
* Pregnancy
MACE and PE in Elective Primary TKA & THA

This study ought to identify the occurence of the major adverse cardiovascular events (MACE) and the pumonary emoblism (PE) in patients undergoing elective primary THA \& TKA

The study included 220 consecutive patients undergoing elective primary THA \& TKA from January 2018 to December 2018. The occcurence of major adverse cardiovascular events (MACE) and the pumonary emoblism (PE) were recorder. Under the term MACE the following were included; non fatal cardiac arrest acute myocardial infraction congestive cardiac failure cardiac arrhythmia agnina stroke cardiovascular death cerebrovascular death

Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients age 18 years or older, with a diagnosis of primary osteoarthritis of the hip or knee, who underwent elective, primary, unilateral TKA or THA.

Exclusion Criteria:

* previous TKA or THA within 3 months
* Revision surgery
* Surgical procedures related to a previous complication
* ASA PS IV
* recent history (6 months) of unstable acute coronary syndrome or decompensated heart failure
Cutaneous JAK in Vitiligo and Acne Vulgaris.

The Janus kinase/signal transducer and activator of transcription (JAK-STAT) cytokine signaling pathway is an emerging area of interest in dermatology, and emerging evidence suggests that this pathway may play a crucial role in pathogenesis of inflammatory skin disorders.

Recent advances on the role of cytokines in the pathophysiology of immune mediated inflammatory diseases lead to the understanding that many pro inflammatory interleukins use JAK/STAT components for signal transduction .

The JAK/STAT signaling pathway transmits information from extracellular chemical signals to the nucleus resulting in DNA transcription. Binding of ligands, such as interferon and interleukins, to their specific transmembrane receptors activate associated JAKs. Phosphorylation of STAT follows, and the phosphorylated STAT translocates to the cell nucleus and activates transcription or suppression of target genes .

The JAK family of non-receptor intracellular tyrosine kinases is comprised of four members, JAK1, JAK2, JAK3 and tyrosine kinase (TyK)2. The JAKs are selectively activated by different receptors and have, therefore, distinct in vivo roles. JAK1 is mainly activated by type II cytokine receptors. JAK2 is crucial in transducing signals for cytokine receptors involved in hematopoiesis (erythropoietin, thrombopoietin and haematopoietic cell development cytokines). JAK3 is mainly expressed in B and T lymphocytes, and TYK2 associates commonly with other JAKs.

Cutaneous JAK overexpression has already been demonstrated in a number of inflammatory skin diseases (ISDs) including psoriasis, lichen planus (LP), atopic dermatitis (AD), pyoderma gangrenosum (PG) and alopecia areata (AA); indicating its crucial role in inflammatory keratinocytes.

Furthermore, the recent discovery of the JAK/STAT signaling pathway opened a new window of opportunity for the treatment of ISDs and promoted the development of drugs that block JAK activation.

JAK inhibitors in oral and topical formulations have shown beneficial results in psoriasis and alopecia areata. Patients suffering from vitiligo might also benefit from JAK inhibition. Recently, significant repigmentation was reported in a patient with vitiligo after treatment with tofacitinib, an oral JAK 1/3 inhibitor . However, the knowledge of the cutaneous JAK involvement in vitiligo is scarce. Similarly, little is known about cutaneous JAK expression in acne vulgaris.

Considering the previous findings, there is a need for further elucidation of the JAK signaling in other skin diseases as vitiligo and acne vulgaris.

Eligibility Criteria:
Inclusion Criteria:

* patients with vitiligo and acne vulgaris.

Exclusion Criteria:

* patients below 12 years of age, or receiving systemic treatments in the last month
Efficacy Study of PAD and TAD in Newly Diagnosed Multiple Myeloma

The primary purpose of this study is to evaluate the efficacy of PAD-regimen and TAD-regimen in newly diagnosed multiple myeloma(MM).

Multiple myeloma (MM) is a malignant tumor with abnormal proliferation of monoclonal plasma cells in bone marrow. Bone damage is one of the characteristic clinical manifestations. Myeloma plasma cells and bone marrow microenvironment are the targets of thalidomide and bortezomib. The regimens based on them as first-line treatments of MM have greatly improved efficacy and prolonged the survival of MM patients. But whether the regimens can prevent and treat bone complications of MM patients or improve the quality of life is not clear. By evaluating the efficacy of PAD-regimen(Bortezomib,Pirarubicin and Dexamethasone) and TAD-regimen(Thalidomide,Pirarubicin and Dexamethasone) in MM and the effect of them on bone lesions, this study can provide evidence of evidence-based medicine for MM treatment.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with symptomatic and measurable newly diagnosed Multiple Myeloma.
* Age \> 18 years, KPS ≥ 60, and life expectancy of at least 3 months.
* Subjects must meet all of the following criteria within 14 days before starting therapy:

PLT≥50×109/L, Hb≥70 g/L, ANC≥0.75×109/L

* Subjects (or their legally acceptable representatives) must signed an informed consent document.

Exclusion Criteria:

* Severe cardiovascular disease ; HIV infection, or positive HBsAg, or active hepatitis C; HBV-DNA\>104; hepatic functional parameter\>2.5 times the upper limit of institutional laboratory normal.
* Grade 2 or more severe peripheral neuropathy or neuropathic pain; Grade 2 or more severe impaired hepatic and kidney function.
* Patient has radiotherapy or major surgery within 30 days before enrollment.
* Patient has hypersensitivity to boron, mannitol or thalidomide.
* Pregnant or breastfeeding women, or subject unwilling to use a method for contraception during the study.
Assessment of the Predictors and Moderators of Health Behavior Change

This study will investigate three interventions-values clarification, planning, or combined (values clarification + planning)-for increasing goal-consistent health behavior (e.g., exercise or dieting). The investigators will also examine how intervention effects differ based on various psychological and neuropsychological factors, to better understand how interventions can be tailored to specific individuals.

The investigators hypothesize a) that the combined intervention will increase goal-consistent exercise behavior more than the other interventions; and b) that individuals scoring higher on self-concordance or goal-commitment will benefit more from planning, whereas those with more positive expectancies or scoring higher on neuropsychological measures (e.g., working memory) will benefit more from values clarification.

The study will be a repeated measures design examining the between-subjects effect of intervention condition (values clarification, planning, and combined) on self-reported health goal progress and related outcomes at 1-week and 4-week follow-up, relative to baseline. Based on this design, participants will first be instructed to generate a health-related goal on which they want to make progress over the course of the next month (following procedures adapted from Little, 1993, and Sheldon \& Kasser, 1998; see details below). Participants will then be randomly assigned (using a random number table) to one of three intervention conditions: (1) values clarification, (2) planning, and (3) combined (values clarification + planning). All conditions are described in more detail below. Fifty-three participants will be randomized to each condition. Questionnaire measures assessing a variety of psychological variables as well as neuropsychological measures will be modeled as between-subject predictor and/or moderator variables of goal-consistent health behavior. Additionally, differences in self-concordance, goal commitment, and expectancies of success will be modeled as potential moderator and/or mediator variables.

Eligibility Criteria:
Inclusion Criteria:

* Boston University Psychology 101 students at least 18 years of age
* Able to provide informed consent for the study
* Sufficient command of the English language
* Have experience using a computer and mouse

Exclusion Criteria:

* None
Evaluation of Non-Invasive Assessment for Post RFAL Procedure Monitoring Using the Nanowear Wearable Multiple Sensor Vest

The objective of this study is to evaluate an experience of post-operative monitoring using the Nanowear wearable multiple sensor vest in plastic surgery


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent to participate in the study.
* Female and male subjects, at least 18 years of age at the time of enrolment
* The patient is scheduled to undergo BodyTite and/or FaceTite procedures.
* The patients should be willing to comply with the study procedure and schedule.

Exclusion Criteria:

* Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
* Pregnancy and nursing.
* Subject unwilling or unable to comply with wearing the Nanowear System 12 hours daily for at least 48 hours Up to 7 days
* As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient
Cannabidiol for Graft Versus Host Disease (GVHD) Prophylaxis in Allogeneic Stem Cell Transplantation

Graft versus host disease (GVHD) is one of the major causes of death in patients undergoing allogeneic hematopoietic cell transplantation. Despite prophylactic measures, the incidence of acute GVHD is estimated at 40-60% among patients receiving transplant from HLA-identical sibling donors, and may even reach 75% in patients receiving HLA-matched unrelated transplants. More effective prevention and treatment strategies are needed.

The immunomodulatory and anti-inflammatory properties of Cannabinoids have been shown in animal models of various inflammatory diseases including multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.

Cannabidiol is a major non-psychoactive cannabinoid, which has potent anti-inflammatory and immunosuppressive effects.

As such, it may reduce the incidence and severity of GVHD after allogeneic stem cell transplantation.


Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing allogeneic stem cell transplantation.
2. No previous history of psychosis. -

Exclusion Criteria:

1. Previous history of psychosis.
2. Consumption of cannabis during the last 2 moths before transplantation. -
Immediate Implant Placement With Provisionalization Using Different Bone Grafts as a Space Filling Material in the Maxillary Esthetic Zone

compare autogenous bone graft, xenograft and nanohydroxyapatite in immediate implant w placement in maxillary esthetic zone with provisionalization

Placement of implants into extraction sockets targets the maintenance of peri implant hard and soft tissue structures and the support of a natural and esthetic contour. The main advantages of immediate implant insertion in comparison with delayed implant placement protocols are as follows: a reduced treatment time, less number of sessions, and, thus, the less invasive procedure. This study examines the clinical performance (survival rate, marginal bone levels and Pink Esthetic Score \[PES\]) of OsseoSpeed™ implants placed into extraction sockets with immediate provisionalization in the anterior maxilla after a follow-up of at least 12 months.

The removal of teeth results inevitably in both horizontal and vertical changes of hard and soft tissue dimensions.

Clinical research has shown that the loss of volume in the extraction sockets is high: the biggest bone volumetric changes take place during the first 12 months from the dental extraction, with a reduction of bone volume of 50%, of which 2/3 (30%) are within the first 3 months.

Nowadays to get success in postextraction implantology means managing the early and irreversible alveolar bone dimensional changes following tooth extraction, in order to minimize the negative effects on the aesthetics final.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with badly broken teeth in upper esthetic zone indicated for extraction
* Both sexes.
* No intraoral soft and hard tissue pathology
* No systemic condition that contraindicate implant placemen

Exclusion Criteria:

* Heavy smokers more than 20 cigarettes per day.
* Patients with systemic disease that may affect normal healing.
* Psychiatric problems
* Disorders to implant are related to history of radiation therapy to the head and neck neoplasia
Supportive Care Needs of Caregivers of People With Erdheim-Chester Disease and Other Histiocytic Diseases

This study is being done to answer the following question: What are the supportive care needs of informal caregivers of people with Erdheim-Chester disease and other histiocytic diseases?


Eligibility Criteria:
Inclusion Criteria:

* Self-identified informal caregiver (family member or friend who provides unpaid support) for a patient with Erdheim-Chester Disease (or LCH, RDD, or JXG for the exploratory aim).
* Proficiency to complete study assessments in English, evaluated at the time of consent.
* Age 18 or over.

Exclusion Criteria:

* Participant unwilling to sign consent.
* Participant unable to complete web-based assessments.
Combination of Radiotherapy and SHR-1210 to Treat Patients With ESCC

SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. This is an open-label，single center ，non-randomized ，Single Arm Exploratory Study . This clinical study is an investigator-initiatedclini-cal trial（IIT ）.The objective of this study is to evaluate the efficacy and safety of radiation therapy combined with anti-PD-1 antibody SHR-1210 in patients with Locally Advanced Esophageal Squamous Cell Carcinomas。


Eligibility Criteria:
Inclusion Criteria:

1. age:18-75 years, male or femal.
2. Histologically confirmed primary Squamous Cell Carcinoma of the Esophagus,Local advanced esophageal cancer diagnosed by pathology and imaging,clinical stage T3-4N0M0, T1-4N+M0,Ⅱ-Ⅳa.
3. Pre-treatment evaluation can not tolerate concurrent radiochemotherapy or rejection of the concurrent use of chemotherapy with radiotherapy.
4. Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
5. ECOG 0-1.
6. Adequate organ function.
7. Life expectancy of greater than 6 months.
8. Patient has given written informed consent.

Exclusion Criteria:

1. Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
2. Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR- 1210 formulation.
3. Subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ);
4. Subjects with any active autoimmune disease or history of autoimmune disease
5. Uncontrolled clinically significant heart disease, including but not limited to the following: (1) \> NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;
6. Active infection or an unexplained fever \> 38.5°C during screening or before the first scheduled day of dosing (subjects with tumor fever may be enrolled at the discretion of the investigator);
7. Received a live vaccine within 4 weeks of the first dose of study medication.
8. Pregnancy or breast feeding.
9. Decision of unsuitableness by principal investigator or physician-in-charge.
Efficacy Study of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery

Efficacy study of Bromfenac Ophthalmic Solution in cataract surgery


Eligibility Criteria:
Inclusion Criteria:

* Male or female at least 18 years of age who are scheduled for unilateral cataract surgery

Exclusion Criteria:

* Have known hypersensitivity to bromfenac or to any component of the investigational product
Methadone in Ambulatory Surgery

The μ-opioid receptor agonist methadone is frequently used in adult anesthesia and adult pain therapy. Methadone has an extremely long half-life, which confers therapeutic advantage by providing more stable plasma concentrations and long-lasting pain relief. Methadone perioperative pharmacokinetics and effectiveness in perioperative pain relief in inpatients is well characterized. There is, however, no information on methadone use in an ambulatory surgery setting and outpatient procedures. This pilot investigation will determine effectiveness of intraoperative methadone in reducing postoperative opioid consumption and providing improved pain relief in patients undergoing moderately painful, ambulatory surgical procedures.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* Undergoing general anesthesia and moderately painful, ambulatory surgical procedures with anticipated overnight, postop hospital stay of \< 24 hours
* Signed, written, informed consent

Exclusion Criteria:

* History of or known liver or kidney disease.
* Females who are pregnant or nursing.
* Opioid tolerant patients (e.g. preoperative methadone therapy or use of fentanyl transdermal patches)
* History of allergy to methadone
Scaling Community-Clinical Linkage Models to Address Diabetes and Hypertension Disparities in the Southeast United States

The purpose of this study is to work with primary care physicians and their staff, and with community health workers (CHWs) to improve diabetes and hypertension management, health behaviors and improve blood pressure for South Asian patients with uncontrolled diabetes and hypertension in primary care clinics in Atlanta, Georgia. The CHWs are community members who are trained to work with patients to address health needs holistically by providing information on wellness, nutrition, stress relief, and blood pressure management in a culturally-appropriate and language-appropriate manner.

The study will provide research training, technical assistance, and capacity-building to community and clinical sites in Georgia for implementation of culturally tailored, evidenced-based CHW programs to improve HTN and diabetes management for South Asians. In addition, the use a multi-theoretical framework to test the effectiveness of a CHW-led intervention compared to usual care among South Asian individuals with diabetes and uncontrolled HTN in Atlanta. The primary outcome is blood pressure control, defined as 130/80 mmHg. It is hypothesized that, compared to usual care, individuals receiving the CHW intervention will be 20% more likely to achieve blood pressure control at 6 months.

And to apply RE-AIM and CFIR frameworks to delineate factors influencing appropriateness, fidelity, adoption, and maintenance of the intervention within clinical and community settings to optimize intervention replication.

In addition, this study will serve as a national information and dissemination resource in the adaptation of evidence-based strategies to reduce geographic disparities in HTN and diabetes across Asian American groups.

Eligibility Criteria:
CHW intervention:

Inclusion Criteria:

* identified as of South Asian ethnicity
* are at least 21 years of age and younger than age 80
* had an appointment with a physician or mid-level clinician for routine non-emergent primary care in the last 12 months
* a diagnosis of diabetes
* a diagnosis of hypertension
* an uncontrolled BP reading (\>130/80mmHg) in the last 6 months

Provider Surveys Inclusion criteria

* clinicians employed by the clinic
* have enrolled into the study.

Key Informant Interviews Inclusion criteria

* must be a provider, clinic manager, or community health worker.

CHW intervention

Exclusion Criteria:

* under the age of 21 and older than 80
* pregnant
* Type 1 diabetes or diabetes secondary to other conditions
* malignancy or life threatening illness with life expectancy of \<5 years
* inability to perform unsupervised physical activity
* diagnosed cognitive deficits or limited decision-making capacity

Provider Surveys Inclusion criteria

* clinicians who are unable to complete the survey in the English language.

Key Informant Interviews Inclusion criteria

* who are unable to participate in the interview conducted in the English language.
Homeopathic Drug Proving Trial

The main aim of the study is to determine whether a homeopathic drug in the potency C12 provokes more characteristic homeopathic proving symptoms after three weeks compared to a placebo in healthy volunteers.

Secondary aims are to develop and to test a qualitative analysis methodology on which to base a definition for drug-specific (characteristic) symptoms and to compile a profile of characteristic homeopathic proving symptoms of the drug being trialled for therapeutic purposes.

This study protocol adapts the traditional homeopathic drug proving methodology to a modern clinical trial design.


Eligibility Criteria:
Inclusion Criteria:

* Medical doctors or medical students
* Not being treated for any acute or chronic diseases on the day of inclusion
* Written informed consent.

Exclusion Criteria:

* Pregnant women or nursing mothers
* Homeopathic treatment over the previous six weeks
* Participation in another clinical trial during the last six months
* Anyone with a personal or professional dependence on the study physician or sponsor
* Anyone who has been placed in hospital or other institution by authorities or decree