cyrilzakka/clinical-trials huggingface dataset:
A Prospective Study of Conventional Bone Marrow Biopsy Versus Portomar(TM) Biopsy

This is a self-controlled, prospective trial. The objective of this trial is to evaluate the efficacy and safety of the Portomar(TM) device for bone marrow biopsy.

This is a self-controlled, prospective trial. Subjects will undergo conventional bone marrow biopsy compared to bone marrow biopsy with the Portomar(TM) device. Subjects will be evaluated at multiple time points comparing the two biopsies. Data through the 6 month time point will be used for Regulatory Submission to the FDA. Additionally subjects will be followed for two years post enrollment.

Eligibility Criteria:
Inclusion Criteria:

* • Patients with a previous bone marrow disorder diagnosis who will require multiple bone marrow biopsies over the course of their treatment, for example patients with plasma cell dyscrasia or leukemia.

  * Men and non-pregnant women of age ≥ 21 years with ECOG performance status ≤ 2.
  * Any hematologic (platelets above 50, ANC \> 1.0, hemoglobin \> 7), renal (patients not on dialysis), or hepatic (patients with bilirubin below 2.5) function status suitable to undergo port implantation and subsequent bone marrow biopsies.
  * Patients must be able to understand and be willing to sign a voluntary informed consent form and agree to compliance with the protocol schedule; with the knowledge that they may withdraw consent at any time without impact on future medical care.

Exclusion Criteria:

* • Patients with any other ongoing, concomitant, comorbid illness including but not limited to uncontrolled diabetes, NYHA class III or worse heart failure, uncontrolled coronary artery disease/arrhythmia.

  * Patients unable to comply with the study schema.
  * Confirmed pregnancy at time of screening or on implantation day prior to anesthesia/sedation.
  * Patients unable to come off of anticoagulation medications for their procedure.
  * Patients with active infection.
  * Patients with \< 0.5 cm or \> 2.5 cm of soft tissue between screw head and skin at the target site of implantation. This is based on the patient's prior imaging studies (i.e. CT/MR or ultrasound imaging).
  * Patient has contra-indication to conscious sedation or anesthesia services
  * Patients who have had prior bone marrow biopsy within 2 weeks of the study biopsy.
  * Patients with coagulopathy such that INR cannot be corrected \< 2.0.
  * Patients who are prisoners or wards of the court.
  * Patients with alcohol or substance abuse disorder defined by DSM V criteria.
  * Patients with the diagnosis of a major psychiatric disorder such as schizophrenia or major depression defined by the DSM-V criteria.
  * Patients with osteoporosis defined as L1 vertebrae bone density lower than 90 Hounsfield units
Altered and Conventional Fractionated Radiotherapy in Patients With Head and Neck Cancer

The aim of our study was to evaluate the value of two different altered fractionation schedules - hyperfractionation and accelerated fractionation with concomitant boost - in comparison with conventional fractionation in primary definitive radiotherapy for squamous cell carcinomas of the larynx, oropharynx or hypopharynx. The study began and was conducted while the only teletherapy unit in our department was the cobalt-60 machine. During that period we were expecting the installation of new sophisticated equipment. We assumed that the results of this study would be also able to show whether or not it would be rational to use the altered fractionation regimens on the new machines.

Eligible patients admitted from March 1999 to December 2000 were treated with conventionally fractionated radiotherapy. These patients represented the retrospective part of the study. Patients admitted between January 2001 and June 2004 were included in the prospective part of the study. Following the confirmation of their eligibility, altered fractionation schedule assignment was made after stratifying by site of origin (larynx vs oropharynx vs hypopharynx), Karnofsky performance score (60%-70% vs 80%-100%), and stage of disease (I and II vs III and IV). Patients were randomized to receive radiotherapy delivered using either hyperfractionation or accelerated fractionation with concomitant boost as a late accelerating component. Exceptions occurred when patients either refused treatment with two daily fractions or were not offered twice-a-day irradiation because of lack of machine time.

Radiotherapy Scheduling and Technique The conventionally fractionated radiotherapy schedule was 66-70 Gy in 6½ -7 weeks (one fraction of 2 Gy per day, 5 fractions per week), whereas the hyperfractionation treatment schedule was 74.4-79.2 Gy in 6.2-7 weeks (two fractions of 1.2 Gy per day, 10 fractions per week with interfraction interval of at least 6 hours; Figure 1). The treatment schedule in accelerated fractionation using concomitant boost consisted of daily fraction of 1.8 Gy, 5 days a week, up to 32.4 Gy including all sites of disease and electively irradiated areas of the neck, followed by two daily fractions for the last 11-12 days. The first daily fraction encompassed all sites of the disease and electively irradiated neck nodes using a dose of 1.8 Gy, and the second daily fraction was the concomitant boost delivered through reduced fields to encompass the gross disease only, using a fraction of 1.5 Gy up to total doses of 68.7-72 Gy in 6 weeks (Figure 1). The interval between the two daily fractions was at least 6 hours.

Eligibility Criteria:
Inclusion Criteria:The inclusion criteria were age 18-75 years, Karnofsky performance score equal or more then 60%, and all stages of disease except stage IVC (TNM classification according to International Union Against Cancer and American Joint Committee of Cancer (UICC and AJCC) from 1997). -

Exclusion Criteria:Patients with previous or concurrent malignancy other then basal cell carcinoma were excluded.

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Behavioral Economics in Provider Incentive Design

The shift towards value-based reimbursement in U.S. healthcare is accelerating. Payment reform initiatives have taken many shapes-accountable care organizations, bundled payments, value-based purchasing, medical homes, global payment-but all share the common strategy of tying provider (physician, hospital, health system) reimbursement to performance on costs, outcomes, or both. Yet, pay-for-performance has demonstrated little effect on physician behavior and patient outcomes. Payers and provider groups are in need of novel approaches to structure provider incentives-both financial and non-financial-to better promote the delivery of quality, cost-effective care. In this project, the study team plans to study how behavioral economic principles can improve the effectiveness of physician incentives to deliver higher quality and lower cost care. They will test the application of specific behavioral economic principles including immediacy, social pressure, and loss aversion in incentive design and implementation. The study will contribute to an empirical foundation for re-design of existing physician incentive programs and implementation of new policies through secondary data analyses and a multi-arm experiment that evaluate the impact of promising behavioral economics principles on the effectiveness of provider financial and nonfinancial incentives.

The key goal of this project is to demonstrate how using behavioral economic principles to inform the structure of provider incentives and the practice environment can improve provider performance, especially in settings that are moving away from fee-for-service reimbursement and fragmented care towards new payment and delivery models that emphasize coordination of care and provider accountability. The project will build upon the recently completed 'Phase 1' project in which a set of behavioral economic approaches to provider performance were identified that could meaningfully improve provider performance, a focused research agenda of high-priority tests of these concepts (i.e., content of this proposal) was developed; and information on how behavioral economics can be used to improve incentives for physicians was disseminated. For this phase, an experimental evaluation will be conducted of the impact of social pressure by varying individual and group incentives and the comparative effectiveness of two loss aversion framing methods (endowment versus performance gap) on provider performance via a multi-arm experiment. We will complement the quantitative evaluations with pre- and post-intervention qualitative surveys of physicians and patients to better understand the influence on behavior change, culture, acceptability of the incentive program, and patient reported outcomes on health and experience.

Eligibility Criteria:
Inclusion Criteria:

* Physician at participating provider organization (PCP and specific specialties)

Exclusion Criteria:

* N/A
Reengineering Methadone Treatment Study of Patient-centered Methadone Treatment

The purpose of the study is to determine whether a change in the rules and staff roles in methadone treatment programs will result in greater lengths of stay in treatment and lower rates of heroin and cocaine use, crime and HIV-risk behavior as compared to methadone treatment as usual.

Early drop-out and premature discharge from methadone treatment is common in the United States and may be associated with drug use and its associated problems. The purpose of this study is to evaluate the effectiveness of a novel approach to the organization methadone treatment in which the patient rules and staff roles of the clinic will be modified for study participants as compared to patients receiving standard methadone treatment.

Eligibility Criteria:
Inclusion Criteria:

* opiate dependence
* newly admitted to methadone treatment

Exclusion Criteria:

* pregnancy
The Effect of Post-Cesarean Section Acupressure on the Severity of Pain and First Mobilization Distance

This randomized controlled trial evaluates the effect of acupressure application on cesareans' pain and the number of steps in the first mobilization. This study hypothesizes that acupressure reduces pain and improves number of steps.

Methods: In the study, 64 cesareans will randomly assigned to acupressure and placebo acupressure groups. To the acupressure group (n = 32), an average of 15 minutes will be applied to the LI4 (liver), P6 (pericardium) and the Sanyinjia points on the splenic meridian (SP6) located on the inner side of the lower leg, four fingers above the ankle and behind the tibia. In the placebo acupressure group (n = 32), the points 1.5 cm away from the LI4, P6 and SP6 points (four points in total) will be applied for an average of 15 minutes. The primary outcome of the research is the effect of acupressure on the pain of cesareans. The secondary outcome of the study is to determine the effect of acupressure on the number of steps. The pain will be collected before and 1 minute, 2nd and 4th hour after acupressure and placebo acupressure administration. The number of steps will be collected 4th hour after acupressure and placebo acupressure administration.

Eligibility Criteria:
Inclusion Criteria:

* Being conscious,
* The mother tongue is Turkish,
* To be oriented and cooperative,
* be between 18-45 years old,
* To voluntarily agree to participate in the study (signing the Informed Consent Form),
* Repeated cesarean section,
* Cesarean section under spinal anesthesia,
* Not having a risky pregnancy (preeclampsia, gestational diabetes etc.),
* No health problems of the fetus,
* To have given birth by cesarean section between 37-40 weeks,
* To be in the second hour of the postpartum period,
* Not receiving post-op patient-controlled analgesia,
* Not to have smoked or used alcohol during pregnancy,
* No complications in the mother and/or newborn after cesarean section,
* No sensitivity in the area where acupressure will be applied,
* Absence of any systemic or psychiatric diagnosis,
* Absence of active COVID-19 infection.

Exclusion Criteria:

* Lack of consciousness,
* The mother tongue is not Turkish,
* Not oriented and cooperative,
* Not to be between the ages of 18-45,
* Refusal to voluntarily participate in the study (those who did not sign the Informed Consent Form),
* Normal birth or cesarean delivery under general anesthesia,
* Cesarean delivery due to the risk of deterioration of maternal or fetal health,
* Not having had a risky pregnancy (preeclampsia, gestational diabetes, etc.),
* Not giving birth outside 37-40 weeks and by cesarean section,
* Not in the second hour of the postpartum period,
* Receiving post-op patient-controlled analgesia,
* To have used cigarettes and alcohol during pregnancy,
* Sensitivity in the area where acupressure will be applied,
* Presence of any systemic or psychiatric diagnosis,
* Active COVID-19 infection.
Psychotrauma Prevention Algorithm : Randomized, Controlled Pilot Study

A randomized pilot study which proposes to patients having suffered a traumatic event to have either only the standard care or the standard care associated with adaptated psychotrauma watch and prevention system.


Eligibility Criteria:
Inclusion Criteria:

* Person who the vital prognosis has or could have been committed or having felt a threat to his physical and/or psychological integrity
* After a potentially traumatic event dating from a minimum of 72 hours to a maximum of 1 week
* for which the CUMP or the psychotrauma regulation platform has been requested
* having lived or being a direct witness of the event
* knowing how to read and write
* affiliate or beneficiary of a social security scheme
* having signed a consent

Non-inclusion Criteria:

* guardianship or curatorship
* unable to receive phone calls
* unable to go to a place for consultation
hsTnT After Elective Coronary Angiography

A prospective Study, aiming to understand and analyse the key role of the novel High Sensitivity Troponin T (hsTnT) within a group of patients undergoing an uncomplicated coronary angiography without receiving any additional intervention. The peri-procedural elevation of the hsTnT indicates some other factors being responsible for the elevation of the hsTnT in absence of an acute coronary syndrome, such as physiological components or micro-injuries. A one year follow-up has been collected.


Eligibility Criteria:
Inclusion Criteria:

- Stable or unknown CAD

Exclusion Criteria:

- Acute Coronary Syndrome
Reducing Prescription Opioid Misuse: ROPEs Pilot Trial

This is a randomized controlled pilot trial to establish methodological feasibility and determine whether a web-based, continuing dental education intervention regarding opioid prescribing risk mitigation strategies - consistent with ADA guidelines - produces pre-to-post changes in knowledge, motivation, and behavioral skills pertaining to the use of risk mitigation strategies when prescribing opioids in dental practice. The current study involves completion of a self-report pre-test (dentists), randomization to complete ROPEs or attention control intervention, completion of a self-report post-test (immediately following intervention/control completion), and completion of 1-month self-report follow-up assessment.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female; any race or ethnicity; age 21-85 years.
2. Able to comprehend English.
3. Be either a licensed dental practitioner currently practicing or a Resident enrolled in the College of Dental Medicine at the Medical University of South Carolina or a practicing dentist in the Charleston-county area or a licensed dental practitioner currently participating in the National Dental Practice Based Research Network (NDPBRN).
4. Report having ever prescribed an opioid analgesic to a patient
5. Must have Internet access
6. Must have a valid, usable email account
7. Must agree to complete all study measurements.

Exclusion Criteria:

1. Unable to provide informed consent due to mental or physical limitations.
2. Participation in ROPEs intervention development focus groups.
Pilot Study for the Development of an Activity and Quality of Life Questionnaire for the Follow-up of Patients With Non-dystrophic Myotonia

Non-dystrophic myotonias (MND) are rare neuromuscular diseases caused by mutations in the voltage-dependent channels of skeletal muscles, resulting in delayed muscle relaxation after voluntary contraction. They include various conditions such as congenital myotonia, congenital paramyotonia and sodium channel myotonia. The main characteristic is myotonia, muscle stiffness accompanied by pain, fatigue and weakness. Symptoms vary in intensity, and fluctuation complicates clinical assessment.

Until now, no validated scale to assess the severity of myotonia is the subject of a consensus among neurologists. It therefore seems necessary to establish a scale to simply and quickly assess the severity of myotonia to fill this need.

The areas of this future scale were identified by the study coordinator based on existing questionnaires and scales. These areas have been validated by a scientific committee composed of expert neurologists.

The main objective of the study is to validate the adequacy and formulation of the scale questions by involving 10 patients who will complete the questionnaire twice to assess its fidelity. At the end of the study, the committee will exclude inappropriate questions. The goal is to create a reliable scale to assess the severity of myotonia.


Eligibility Criteria:
Inclusion criteria:

* Male or female, over 18 years of age;
* With genetically diagnosed non-dystrophic myotonia;
* Affiliated with a Social Security system;
* Able to read, understand and speak French
* Having expressed his non-opposition

Exclusion criteria:

* Subject participating in an interventional study with experimental drug or in the exclusion period of an interventional study;
* Pregnant or lactating women for women of childbearing age;
* Patient protected by law under guardianship or curators, or who cannot participate in a clinical study under Article L. 1121-16 of the French Public Health Code
Acute Effects of Continuous Verses Interval Aerobic Training in Spinal Cord Injury Patient

To determine the Acute effects of continuous verses interval aerobic training on autonomic dysreflexia in Spinal Cord injury Patient. To Determine the Acute effects of these training on, Exercise Self efficacy and pain.


Eligibility Criteria:
Inclusion Criteria:

* Spinal cord injury Patients with level of injury below T 10
* Acute Spinal Cord Injury (Usually Acute phase lasts 8-12 weeks)
* Patients Had experience of Syncope or Postural Hypotension

Exclusion Criteria:

* Neurological disease,
* Cognitive impairment (Mini-Mental State Examination \< 22) ,
* Acute and chronic infections
The Relationship Between the Response to Mental Stress and Vascular Endothelial Function

The aim of this study is to measure how different people respond to mental stress. The investigators will measure if there are differences in cardiovascular responses to mental stress among different groups of subjects. In one part of the study the investigators will compare the cardiovascular responses to mental stress between healthy women and healthy men. In another part of the study, the investigators will compare the cardiovascular responses to mental stress between women with apical ballooning syndrome and healthy post-menopausal women. The investigators hypothesize that healthy men will have an increased vascular response to and decreased endothelial function in response to to mental stress, compared to health women. Furthermore, the investigators hypothesize that women with apical ballooning syndrome will have an increased vascular response to and decreased endothelial function in response to mental stress.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be identified in one of the four groups outlined in "study population description."

Exclusion Criteria:

* Other co-morbidities that would make the testing not possible.
* Women who have had a mastectomy and would not have an arm that could be occluded during the reactive hyperemia portion of the Peripheral arterial tonometry testing.
Pharmacotherapy and Intensive Treatment - 2

The purpose of this study is to evaluate desipramine and carbamazepine in reducing cocaine craving; increase outpatient treatment capacity and evaluate their incidence of psychiatric disorders.


Eligibility Criteria:
Please contact site for information.
Selecting a Favorable KIR Donor in Unrelated HCT for AML

Donors with favorable KIR B haplotype gene content have yielded reduced relapse risk and improved leukemia free survival (LFS) in retrospective analyses of unrelated donor (URD) hematopoietic cell transplantation (HCT) for acute myelogenous leukemia (AML). Specifically, donors with more KIR B gene content and those who are homozygous for the centromeric (Cen) B haplotype genes (as opposed to the telomeric (Tel) genes confer the most protective effect. This study proposes to prospectively test and validate the utility and effectiveness of further informing URD identification and selection by KIR genotyping as a supplement to HLA matching and the other variables known or suspected to indicate the best URD for a patient.

Hypotheses:

1. Favorable KIR donors will improve protection against relapse and improve leukemia free survival (LFS) after URD HCT for AML.
2. Directed study procedures for rapid KIR genotyping and reporting to searching Transplant Centers (TC) can inform donor search and selection without delay in donor availability for HCT.

Transplant Centers will select the best HLA matched, and as appropriate, preferred KIR donor.

Eligibility Criteria:
Inclusion Criteria:

* Patient with acute myeloid leukemia (AML) undergoing screening for potential URD HCT
* Potential URD undergoing screening to provide a HCT graft to a patient with acute myeloid leukemia (AML) at a participating institution
* Provides written consent

Exclusion Criteria:

Transplant Centers will select the best HLA matched, and as appropriate, preferred KIR donor. In situations where the preferred (best \> better \> neutral) KIR donor is not selected in favor of a less favorable KIR genotype donor, the center will report one or more defined reasons (donor age; gender; parity; CMV status; ABO status; availability/logistics; other) for the choice (among equivalently HLA matched donors).
Effectiveness of Group Psychotherapy in Patients With Fibromyalgia Syndrome

The hypothesis of the study is that group therapy in fibromyalgia patients can provide significant improvement in pain, fatigue, anxiety and depression levels and emotional expressions.

The purpose of our study; to determine the effectiveness of group psychotherapy in the treatment of Fibromyalgia Syndrome.

Patients who received 9 weeks of group therapy and those who did not, at the beginning of treatment, at the end of 9 weeks and 6 months after treatment will be evaluated using The Short Form-36, Fibromyalgia Impact Questionnaire, Revised Fibromyalgia Impact Questionnaire, Hospital Anxiety and Depression Scale, Fatigue Severity Scale, Beck Depression Inventory, Beck Anxiety Inventory, Pain Beliefs Scale, Emotional Expression Questionnaire, Visual Analogue Scale, Childhood Trauma Questionnaire, 2016 Fibromyalgia Diagnostic Criteria.

At the end of the study, individuals are expected to show less depressive symptoms and anxiety symptoms compared to the beginning of the study, and it is thought that their complaints about pain will decrease.

Eligibility Criteria:
Inclusion Criteria:

* Fibromyalgia Syndrome diagnosed according to 2016 Fibromyalgia Syndrome diagnostic criteria
* Volunteers between the ages of 18-65
* Literate volunteers
* Volunteering to participate in group work
* There is no obstacle to attend the sessions regularly every week

Exclusion Criteria:

* Who cannot participate in 9-week group therapy
* Under 18, over 65 years old
* Confused enough to not be able to complete and understand the scales given cognitively
* Having serious mental illness (eg Psychotic disorder, Mental Retardation etc.)
* Illiterate individuals