cyrilzakka/clinical-trials huggingface dataset:
Vaccine Therapy for Multiple Myeloma Utilizing Idiotype-Pulsed Allogeneic Dendritic Cells

Patients with Multiple myeloma who have undergone non-myeloablative allogeneic stem cell transplant will receive 6 vaccinations of donor derived dendritic cells combined with specific protein produced by multiple myeloma.

To evaluate feasibility and safety of vaccination with allogeneic idiotype-pulsed dendritic cells following mixed chimeric allogeneic transplantation for multiple myeloma.

Eligibility Criteria:
Inclusion Criteria:1. For specimen collection and idiotype protein development:

* Must be secretory myeloma with at least .5g/dl serum IgG protein
* Clinically stage 2 or 3 multiple myeloma
* Karnofsky performance status of 70 or greater

  2. For Vaccination:
* Eligible patients must have completed tandem autologous and nonmyeloablative allogeneic transplant for multiple myeloma at Stanford University Medical Center with stable disease or complete response to prevaccine therapy
* Karnofsky performance status of 70 or greater.
* ALT and AST must be \<2X upper limit of normal. Total bilirubin \< 1.5X upper limit of normal.
* Serum creatinine \<1.5X upper limit of normal.
* Hemoglobin \>9g/dl
* Patients must be HIV negative.
* Patients must provide signed, informed consent

Donor Inclusion Criteria (allo donor is the same donor used for non-myeloablative transplant)

* Age \>17 years
* HIV negative
* Must provide signed, informed consent Exclusion Criteria:1. For specimen collection and idiotype protein development:
* Patients with non-secretory myeloma
* Severe psychological or medical illness
* Pregnant or lactating women
* Subjects with \> Grade I toxicity by NCI-CTC v 3.0
* Subjects with prognosis \< 6 months

  2. For Vaccination:
* \< 75 mg of idiotype protein purified from the patients serum
* \< 25 million allogeneic idiotype-pulsed dendritic cells produced for vaccination
* Evidence of grade II-IV acute GVHD (defined in section 5E)
* Patients with evidence of myeloma disease progression as (defined below)
* Severe psychological or medical illness or concomitant medications which may interfere with the study as determined by the clinical investigator
* Patients on any other investigational agents
* Pregnant or lactating women
* Patients on any therapy for multiple myeloma or any chemotherapy drug, or immunomodulatory agent for treatment of multiple myeloma (e.g. thalidomide)
* Any patient on more than two of the following immunosuppressive agents or at a dose greater than that indicated for a single immunosuppressive agent:

  1. Mycophenolate Mofetil (MMF)- no greater than 1000mg twice a day
  2. Prednisone- no greater than .5mg/kg/day
  3. Cyclosporine- no greater than 300mg/day
  4. Tacrolimus (FK506)- no greater than 4mg/day
Most Preventable Surgical Option to Reduce Primary Spontaneous Pneumothorax Patients' Postoperative Recurrence: A Prospective Cohort Study

To investigate the most preventable option to reduce primary spontaneous postoperative recurrence.

Pneumothorax is a disease in which air in the lungs leaks into the pleural cavity. It is a disease that occurs most often in young people with active social activities, and it occurs in about 100,000 people in 14 cases. The recurrence rate is as high as 17% to 54%, and the delay of the rehabilitation by the ambulatory with the treatment and prolongation of the hospitalization becomes a problem. It becomes a large failure for the youth who requires early rehabilitation. According to the latest report from the Japanese Society of Surgery, approximately 12,000 pneumothorax surgeries are performed annually in Japan. Many of them applied absorbent material to the surgical stump (coverage technique). However, there are no prospective studies, and efficacy does not appear adequately tested. It is necessary to accumulate prospective data from multiple centers to investigate the coverage technique's real effect.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who have spontaneous pneumothorax diagnosed by radiography and plan to underwent initial VATS bullectomy.
2. Patients who receive informed consent to attend this study, and the agreements are provided in a document.

The consent of parents is also required, in case patients are under 20-years old.

Exclusion Criteria:

1. History of ipsilateral chest surgery.
2. Patients who only underwent exploratory surgery.
3. Patients who are judged ineligible by the investigator and the attending surgeon.
Dual Transversus Abdominis Plane Block in Pediatric Renal Transplant: Effect on Pain Control

Alleviating pain in children undergoing renal transplant is extremely challenging. Large incisions as those of renal transplant (Gibson's incision) require special techniques of pain control that don't affect hemodynamics or renal function. Since the transplant incision doesn't cross midline; a dual-TAP block is thought to be effective in providing pain control in such procedure as it will anesthetize the dermatomes T6-T12, the muscles of the anterior abdominal wall together with the underlying parietal peritoneum.


Eligibility Criteria:
Inclusion Criteria:

* 3-16 years
* end stage renal disease
* no known allergy to bupivacaine
* both sexes

Exclusion Criteria:

* known allergy to bupivacaine
Knowledge of Predicting Increased Risk for an Overuse Injury in Runners

The purpose of this study is to examine the skeleton of the legs and the running style in order to predict a possible overuse injury.

The running style and the training composition and the body composition are thought to have major effect on the development of overuse injuries.

To define a prevention strategy, one must have the knowledge about risk factors and causation. The training composition is very relevant clinically but the underlying factors have not been studied yet. For the present there is no scientifical evidence of a possible relation between the body composition such as the mutual length and width of femur and tibia and the development of overuse injuries.

Thus, the aim of this study is to achieve evidence-based knowledge of these factors in order to advice runners about the precautions and to avoid that people get a sedentary lifestyle.

Eligibility Criteria:
Inclusion Criteria:

* Men between 18 and 60 years
* Access to an e-mail
* Two years running experience as a minimum
* Exercises three times weekly as a minimum, on annual average or until any excessive load on the body occurs
* Experience with running machines
* A written signed statement of consent

Exclusion Criteria:

* Lack of a written signed statement of consent
* Unwillingness to keep a journal during the running exercises
* Unwillingness to register data during the follow-up period
* Injury in the lower extremities within 3 months before baseline
* The runner uses insoles or he has been through a surgical procedure in the lower extremities
* A mental disability for example dementia or challenging behaviour
* The runner plays heavy sport, cf. American College of Sports Medicine
* Unability to read or understand Danish
* Unability to cooperate
Using MRI to Identify Areas to Receive Lower Doses of Radiation Treatment in Men With Prostate Cancerdose Mapping to Preserve Quality of Life

The purpose of this research is to gather information on the safety and effectiveness of using an imaging technique called magnetic resonance imaging (MRI) to decrease radiation dose to the uninvolved prostate (areas of the prostate that do not clearly have cancer cells) while increasing radiation dose to the nodules (hardened areas of the prostate that have cancer cells).


Eligibility Criteria:
Inclusion Criteria:

* Adult (≥ 18 years old) male patients with an ECOG Performance Status 0-2
* Histologically-confirmed, MRI-visible prostate adenocarcinoma with NCCN intermediate- or high-risk disease1 without extra-pelvic metastasis.

Exclusion Criteria:

* Distant metastases
* Prior active treatment for prostate cancer including radical prostatectomy, high-intensity focused ultrasound (HIFU), cryosurgery, ADT, or cytotoxic chemotherapy for treatment of prostate cancer. Patients with prostate cancer on active surveillance prior to the study are not excluded if they have not received active treatment.
* Prior pelvic radiotherapy including brachytherapy.
* Additional active concurrent malignancies (except localized cutaneous squamous or basal cell carcinomas).
* Comorbid conditions that, in the opinion of the treating radiation oncologist, preclude the patient from safely receiving the protocol-specified treatment including RT and/or ADT.
* Patients with contraindications to MRI including patients with ferromagnetic materials in their body (e.g. bioimplants, surgical hardware, shrapnel), patients who are unable to receive contrast due to history of allergy or impaired renal function (glomerular filtration rate \< 30 mil/min), and patients unable to tolerate MRI for other reasons (e.g. significant claustrophobia).
* Patients for whom hydrogel or hyaluronic acid spacer will be placed.
* Patients incapable of giving informed consent.
* Patients who are unable to adhere to the experimental protocols for any reason.
A Study to Determine an Effective Dose of Epoetin Alfa to Decrease the Number of Units of Blood Required to be Transfused During Hip Replacement Surgery.

The purpose of this study is to determine an effective dose of epoetin alfa to be administered prior to surgery, to decrease the need for blood transfusions during hip replacement. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.

Major surgical procedures may require blood transfusions both during and after the operation. Agents that can increase the rate of red blood cell production would reduce the need for blood transfusions. Epoetin alfa is a genetically engineered form of a natural hormone, erythropoietin, that stimulates red blood cell production. This is a randomized, double-blind, multicenter study in patients scheduled for first time hip replacement surgery. The study compares the effectiveness of 2 different doses of epoetin alfa (20,000 units or 40,000 units per week) for reducing the need for blood transfusions during the surgery. Eligible patients will be randomly assigned to one of three treatment groups: epoetin alfa 20,000 units per week, epoetin alfa 40,000 units per week, or placebo. Patients will be treated with study medication once a week for 4 weeks before their scheduled surgery. Effectiveness will be determined by the number of transfusions required during surgery. Other factors that determine effectiveness will be: the level of hemoglobin (the oxygen-carrying component of red blood cells) and the percentage of red blood cells in the patient's blood (hematocrit) prior to surgery; the number of developing red blood cells (reticulocytes); the iron stores in the patient's blood prior to surgery; the patient's quality of life after the surgery; and the time that elapses after surgery before the patient is discharged from the hospital. Safety evaluations will include the incidence of blood clots in the deep veins, the incidence and severity of other adverse events, and changes in clinical laboratory tests, vital signs, and physical examination findings throughout the study. The study hypothesis is that patients treated with epoetin alfa before hip replacement surgery will require fewer blood transfusions during the surgery compared with patients treated with placebo, and that the lower epoetin alfa dose (20,000 units per week) is as effective as the higher epoetin alfa dose (40,000 units per week). Patients will receive 20,000 units or 40,000 units of epoetin alfa injected under the skin once weekly for 4 weeks, or a matching placebo injection containing human serum albumin.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for first-time hip replacement surgery
* having no major medical conditions
* having a hemoglobin level of 98 - 137 grams per liter
* having adequate iron stores
* not participating in a self-donated blood program

Exclusion Criteria:

* Patients with a history of rheumatoid arthritis, blood disorders, recent bleeding episodes or an iron deficiency
* or having a history of seizures or uncontrolled high blood pressure (diastolic blood pressure \> 100 mmHg)
Further Psychometric Data for the Reliability and the Diagnostic Validity of CRS-R

This study aims to provide, in a large sample, further psychometric data as regards the internal consistency, the test-retest reliability and the diagnostic validity of the Coma Recovery Scale-Revised (CRS-R).

Recently, a report of the American Congress of Rehabilitation Medicine aiming to provide a systematic review of behavioral assessment scales for DOC has indicated that, when compared to other scales, the CRS-R meets the highest psychometric standards for the evaluation of severely brain-injured patients and may be used to assess DOC with minor reservations. However, that report mentions few evidences or studies with small sample sizes for some aspects of its reliability and validity such as its internal consistency and its test-retest reliability.The report also states that the diagnostic validity of the CRS-R remains unproven. In this study, the investigators will therefore aim to provide further psychometric data as regards those variables in a large sample of patients with DOC

Eligibility Criteria:
Inclusion Criteria:

* age above 18 years old
* any etiology
* pre-screening performed by the referent physician comforting the presence of a disorder of consciousness in accordance with international diagnostic criteria for VS, MCS or emergence from MCS (EMCS)

Exclusion Criteria:

* neuromuscular blocking agents or sedative drugs administered within the prior 24 hours
* no documented history of a prior coma
* critical illness or unstable medical condition
Muscular and Joint Symptoms in COVID-19 Patients: Insights From Syria

Observation study, shows the relation between musckeloskeletal symptoms with during and post Covid-19 infection, by asking participants questions about there age,job,which vaccination covid participants took, residual area, social status, number of time of covid-19 infection, number of joint affected and duration of joint pain and asking if there any malaise or fatigue


Eligibility Criteria:
Inclusion Criteria:

* Participants aged ≥ 18 years with a prior COVID-19 infection or suspicious COVID-19 infection and currently residing in Damascus.

Exclusion Criteria:

* Participants below 18 years, those unwilling to give consent, individuals with joint surgery history, pregnant women, or those who had taken immunosuppressive drugs before the study.
Effectiveness of Microcurrent for Treatment of Tennis Elbow

Tennis elbow is a relatively common musculoskeletal disorder that can cause significant pain and disability. Treatment of the disorder is not always successful, and it often recurs or becomes chronic. More effective management options are required. There is evidence that electric microcurrent can promote tissue healing and symptom resolution in various chronic hard and soft tissue disorders, but few human studies investigating its use with chronic tendon problems. It is an easily applied therapy with very few reports of side effects. It can be applied at home using a portable unit and, if it is clinically effective, may also prove more cost effective than other therapies.

A clinical trial is planned to evaluate the therapy but, in the absence of relevant published evidence, a preliminary study is required to look for a treatment effect and inform a power calculation for sample size, The study will also allow some investigation of dose-dependence, which is a key issue in many forms of electrotherapy. Finally it will enable evaluation of elements of the full trial protocol so that any weaknesses can be addressed before it begins.


Eligibility Criteria:
Inclusion Criteria:

* symptoms of tennis elbow for at least 3 months
* clinical diagnosis of tennis elbow

Exclusion Criteria:

* significant symptom improvement in previous month
* receipt of any active treatment for the condition in the previous month
* currently under the care of another health professional for tennis elbow
* current cervical radiculopathy
* other pathology affecting distal upper limb
Effects of Manualized Treatment in a Seamless System

The specific aims of this project are:

1. To conduct a randomized block experiment to test the effectiveness of different models of the seamless supervision/treatment system and traditional criminal justice supervision on reducing recidivism and drug use, and improving social adjustment among offenders;
2. To understand the differential impacts based on offender risk factors (e.g., propensity to engage in further criminal behavior) on criminal justice outcomes and to determine whether differences found between seamless and traditional system participants are moderated by offender risk level;
3. To understand differential treatment and social adjustment outcomes (e.g., treatment progress, employment status) of different types of offenders participating in various treatment services; and
4. To examine levels of systems and service integration between the supervision and treatment systems pre- and post-intervention and to measure the impact of integration on outcomes over time.


Eligibility Criteria:
Inclusion Criteria:

* Substance abusers

  * men and women
  * treatment

Exclusion Criteria:

* Parolees

  * Low threshold substance abuse
  * violent offenders
Prospective Clinical Trial of the Hemopatch Topic Hemostatic in Cardiac Surgery

A new topical hemostatic agent composed of a specifically-formulated porous collagen matrix, coated on one side with a thin protein bonding layer (known as NHS-PEG) has been reported to be extremely effective, in addition to traditional means, in terminating bleeding during cardiac operations with control rates as high as 97,5%. The investigators compared such hemostatic agent (Hemopatch; Baxter Inc, Deerfield, IL) with traditional optimized hemostasis routine.

Following sample size calculation, in a prospective randomized study design, 100 patients will be treated with Hemopatch and 100 patients will receive traditional optimized hemostasis routine (comparison group).

To make the two cohorts as comparable as possible enrollment will be restricted to moderately bleeding vascular anastomosis of Dacron grafts to ascending aorta or moderately bleeding transversal aortotomy.

Study endpoints are the following: rate of successful intraoperative hemostasis (identified by cessation of bleeding in less than 3 minutes from application) and time required for hemostasis; overall postoperative bleeding; rate of transfusion of blood products; rate of surgical revision for bleeding; postoperative morbidity; and intensive care unit stay.


Eligibility Criteria:
Inclusion Criteria:

* Surgery on Ascending Aorta with Dacron Graft or transverse Aortotomy
* Moderate bleeding

Exclusion Criteria:

* None
Influence of Lumbar Ultrasound on Resident Learning Curve for Lateral Labor Epidural Placement

The aim of this study is to evaluate the impact of lumbar spine ultrasound on the success rate and efficiency of labor epidural placement in the lateral position. The investigators hypothesize that ultrasound imaging of the lumbar spine of women in early labor will yield similar ultrasound results when done immediately prior to epidural placement. The investigators also hypothesize that the use of ultrasound with landmarks marked and depth to the epidural space estimated will facilitate epidural placement in terms of both efficiency (time required for placement) and efficacy of pain relief.

Several studies have demonstrated a significant benefit in pre-procedural ultrasound for epidural placement by anesthesia residents, particularly when performed in the obese population. To the investigators knowledge, however, no studies have evaluated this teaching modality for the lumber epidural technique in the lateral position. Formalizing the educational process for this less frequently performed, highly technical and critical skill may have a profound impact on trainee learning curves, and may enhance the overall success and efficiency of epidural placement, quality of analgesia provided, and safety of the procedure.

Eligibility Criteria:
Pregnant Subjects

Inclusion Criteria:

* pregnant women
* 18 years or older
* in early labor (cervix dilated \< 5 cm
* pain visual analog score (VAS) \< 3, or both) requesting consultation by the anesthesia team for anticipated epidural pain relief.

Exclusion Criteria:

* absolute contraindications of neuraxial anesthesia including patient refusal
* uncorrected coagulopathy
* infection at the skin site of epidural placement
* increased intracranial pressure, or untreated hemodynamic instability.
* In addition, patients with a history of scoliosis or spine surgery
* body mass index (BMI) \>40 kg/m2
* allergy to local anesthetic, or allergy to opioids will be excluded.

Anesthesiologists

Inclusion criteria:

* Anesthesia residents or fellows who are performing the epidural technique in pregnant subjects who agree to be part of the study.
* Anesthesia residents or fellows with prior experience in the lumbar epidural technique, defined as having placed 20 or greater lumbar epidurals during their residency and prior to enrollment.

Exclusion criteria:

* individuals who do not want to participate in the study.
Effect of Two Different Dosages of Ethinyl-estradiol in Association With Drospirenone in Women With Polycystic Ovary Syndrome.

The estrogenic component of estro-progestin (EP) is responsible for a negative impact on the metabolic and lipid assessment in women with polycystic ovary syndrome (PCOS).

The objective of this study is to compare the effects of a long term administration of two EP combinations, containing the same progestin (3 mg drospirenone) and a different dose of ethinyl-estradiol (EE) (20 vs 30 μg ) on the clinical and endocrine-metabolic parameters in normal weight PCOS women. The investigators enrolled 30 patients, randomly allocated to group A (20 µg EE - 3 mg DRSP) and 15 to group B (30 µg EE - 3 mg DRSP). Hirsutism score evaluation, hormonal assays, oral glucose tolerance test, euglycaemic hyperinsulinaemic clamp and lipid profile were performed at baseline and after 6 and 12 months of therapy.


Eligibility Criteria:
Inclusion Criteria:

* normal weight women with Polycystic ovary syndrome, diagnosed in accordance with Rotterdam Consensus Conference Criteria 2003.

Exclusion Criteria:

* pregnancy
* past history of cardiovascular disease, diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 g oral glucose tolerance test), hypertension
* significant liver or renal impairment
* other hormonal dysfunction (hypothalamic, pituitary, thyroidal or adrenal causes for the clinical signs)
* neoplasms
* unstable mental illness