cyrilzakka/clinical-trials huggingface dataset:
The Effect of Touch on Pain and Anxiety During the Bone Marrow Biopsy Procedure

This study is analyzing the benefit of untrained touch provided during a bone marrow biopsy procedure as compared to performing the procedure without providing it.

Two protocol-identified licensed nursing aides (LNA) will provide an unstructured simple touch intervention that requires no special training other than being oriented to "rub patient's feet" during the procedure. Data will be collected through patient-reported outcomes to determine if "untrained" touch has therapeutic results in managing a patient's pain and anxiety during a bone marrow biopsy procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Patients from Norris Cotton Cancer Center who have been scheduled for a bone marrow biopsy at the Outpatient Surgical Center at Dartmouth-Hitchcock Medical Center.
2. Subjects must be able to read and write in English to provide informed consent and fill out the questionnaires.

Exclusion Criteria:

1. Patients who do not wish to have their feet and lower legs touched during the procedure
2. Open sores on their feet or lower legs.
Efficacy and Safety of Two Anti-T-lymphocyte Immune Globulin (ATG-F) Induction Regimens in Anew Kidney Transplant Patients

To investigate the efficacy and safety of ATG-F induction regimen using a single dose of ATG-F compared with a five-day dose regimen of ATG-F in anew kidney transplant recipients.

To investigate the efficacy and safety of ATG-F induction regimen using a single dose of ATG-F compared with a five-day dose regimen of ATG-F in de novo kidney transplant recipients. The primary analysis of this study is to demonstrate the non-inferiority of the two regimens with regard to efficacy, defined as failure rate.

The secondary objective of the study is the assessment of safety and further efficacy parameters in terms of incidence of acute rejections, graft/patient survival, DGF(delayed graft function) and renal function

Eligibility Criteria:
Inclusion Criteria:

* Patient with end stage kidney disease who is a suitable candidate for primary kidney transplantation.
* Patients scheduled to undergo renal allograft transplantation with compatible ABO blood type.
* Peak PRA \<50%
* Females of childbearing potential must have a negative pregnancy test within 48hrs prior to randomization and reliable methods of contraception should be started 4 weeks prior to and during the whole study.
* Patients capable to understand the purposes and risks of the study, who are willing and able to participate in the study and from whom written and dated informed consent to participate in the study is obtained.

Exclusion Criteria:

* Subject has previously received or is receiving an organ transplant other than kidney
* Subject is receiving double-kidney transplant.
* Subject is receiving an ABO incompatible or T-cells cross match positive transplant.
* Cold ischemia time of allograft is \> 24 hours before kidney transplantation surgery.
* Subject is receiving organ from a Human Leukocyte Antibody (HLA) identical donor.
* Known contraindication to administration of ATG-F, including:

  * Subject has known hypersensitivity to rabbit proteins
  * Subject with severe thrombocytopenia
  * Subject with bacterial, viral or mycotic infections which are not under therapeutically control
* Subject has known hypersensitivity to tacrolimus, macrolide antibiotics, mycophenolate mofetil, or any of the product excipients.
* Subject is unlikely to comply with the visits scheduled in the protocol in the opinion of the investigator or has a history of non-compliance.
* Pregnant women, nursing mothers, lactating women, and women of child-bearing potential who are unwilling to use reliable contraception during the study and for 6 weeks following completion of the study.
* Patients with evidence of active liver disease (liver function tests ≥ 2 times upper limit of normal) or the presence of a chronic active hepatitis B or C.
* Recipient or donor is seropositive for human immunodeficiency virus (HIV).
Evaluating the Safety and Efficacy of Proellex® (CDB-4124) in Premenopausal Women With Symptomatic Uterine Fibroids

Premenopausal women with symptomatic uterine fibroids will be randomized to either Proellex 25mg or 50mg or placebo for one treatment cycle (four months). Safety and effectiveness between 50 mg versus placebo, and between 25mg and placebo will be analyzed.

Subjects with documented uterine fibroids, screening UFS-QOL severity score of at least 40, and meeting other eligibility criteria will be enrolled in the study. Following screening and a pre-treatment endometrial biopsy, subjects will be assessed monthly for the four (4) month double-blinded treatment phase. The study duration is approximately six months, comprised of a one-month screening period, 4 month treatment period and one month follow-up period. Subjects' blood will be drawn in a fasting state to obtain the pre-dose trough (PK) levels of study drug at each study drug dosing/dispensation visit to determine the potential for drug accumulation.

Eligibility Criteria:
Inclusion Criteria:

* Speak, read and understand English or Spanish;
* Not have undergone hysterectomy, uterine arterial embolization or endometrial ablation therapy (previous myomectomy is acceptable) for any cause and no surgical interventions for uterine fibroids (e.g. hysterectomy, myomectomy, uterine arterial embolization) are planned or anticipated during the study;
* One uterine fibroid must be identifiable and measurable by transvaginal ultrasound;
* Menstrual cycle lasting from 24 to 36 days;
* History of excessive menstrual bleeding;
* Negative urine pregnancy test at screening.

Exclusion Criteria:

* Six months or more (immediately prior to Screening Visit) without a menstrual period;
* Prior hysterectomy;
* Prior bilateral oophorectomy;
* Pregnant or lactating females or women who are attempting or expecting to become pregnant at any time during the study;
* Documented endometriosis, active pelvic inflammatory disease (PID), platelet dysfunction, or Von Willebrand's Disease;
* Any history or diagnosis of gynecological cancer or cervical dysplasia of any grade including atypical squamous cells of undetermined significance (ASCUS) associated with Human Papilloma Virus (HPV);
* Subject with diagnosed or suspected carcinoma of the breast, reproductive organs or any other organ system;
* Subject with known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or Chlamydia or previous history of auto-immune disease or positive serum antinuclear antibodies.
Cardiopulmonary Exercise Testing and Oscillometry for the Evaluation of Dyspnea

This study will determine if airway resistance to airflow and pressure, measured by Oscillometry, is associated with abnormal findings on Cardiopulmonary Exercise Testing in subjects who are experiencing shortness of breath.


Eligibility Criteria:
Inclusion Criteria:

* Willingness to perform breathing test
* Must be able to speak and understand English
* Referred for Cardiopulmonary Exercise Testing

Exclusion Criteria:

* Unable to provide consent or perform oscillometry test
Safety of a New Type of Treatment Called Gene Transfer for the Treatment of Severe Hemophilia B

In this study a modified virus called adeno-associated virus (AAV) will be used to transfer a normal gene for human clotting factor IX into patients with severe hemophilia B (AAV human Factor IX vector). Gene therapy is a very new medical technique being used in a number of clinical studies for diseases such as cancer and cystic fibrosis. At this time, the U.S. Food and Drug Administration has approved no gene transfer products for commercial use. To date, 8 subjects have received AAV vector in the muscle for a hemophilia B trial by intramuscular injection, and, to date, 6 subjects have been treated with AAV vector in the current hemophilia B liver trial. Eleven cystic fibrosis subjects have received AAV vector into their nasal sinuses or lungs to date. In this study, AAV human Factor IX vector will be injected into the liver using a catheter inserted into a large blood vessel (called the proper hepatic artery or the right hepatic artery).


Eligibility Criteria:
* Males with severe hemophilia B with Factor IX activity level \< 1% of normal.
* Life expectancy of \> 1 year.
* Age \> 18 years old.
* Ability to give informed consent.
* Greater than twenty exposure days of treatment with Factor IX protein.
* No history or presence of an inhibitor to Factor IX protein.
* Subjects must be able to receive Factor IX protein on a home infusion protocol.
* Subjects must have a normal protime (PT).
* Hepatitis C infected subjects will be evaluated for liver fibrosis based on liver biopsy data graded on a scale of 0-4 (Poynard et. al., 1997). Subjects who are Hepatitis C antibody and RNA positive and have not had a liver biopsy within the last 36 months will be required to have one.
* Subjects must have low AAV titer.
Evaluation of Above the Cuff Suctioning During General Anesthesia

The aim of this prospective, randomized, pilot study is compare ease of tracheal intubation, amount of microaspiration and efficacy of secretion removal using three FDA (Food and Drug Administration)-cleared endotracheal tubes (ETT) after the induction of general anesthesia in the operating room (OR). Studies in the intensive care unit (ICU) have demonstrated a significant reduction in the incidence of ventilator acquired pneumonia when a ETT with suction above the cuff is used to remove secretions that accumulate above the inflated cuff. This will be the first study to evaluate the efficacy of above the cuff suctioning during general anesthesia and surgery.

One hundred and ten adult patients undergoing elective abdominal surgery (general, colorectal or gynecological) requiring general anesthesia with an endotracheal tube and mechanical ventilation will be randomized into 3 groups to receive one of the following three endotracheal tubes:

1. Teleflex ISIS HVT Cuffed Tracheal Tube with Subglottic Secretion Suction Port Endotracheal Tube (Teleflex ISIS ETT).
2. Mallinckrodt TaperGuard Evac Endotracheal Tube (TaperGuard Evac ETT).
3. Mallinckrodt Intermediate Hi-Lo Endotracheal Tube. (Standard ETT)

The first two groups will be compared to standard ETT (third group) regarding easy of tracheal intubation, efficacy of suctioning of secretions, efficacy of sealing the trachea with an inflated ETT cuff by preventing the movement of test dye (methylene blue) from the pharynx into the trachea and incidence of post-operative respiratory complications.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for elective abdominal surgery with an anticipated duration longer than 2 hours.
* ASA (American Society of Anesthesiologists) Physical status Classification 1 to 3. (1 - normal healthy patient, 2 - patients with mild systemic disease, 3 - patients with severe systemic disease)
* Endotracheal intubation anticipated to be routine (not difficult) based upon preoperative airway assessment

Exclusion Criteria:

* Short duration surgery (anticipated \< 2 hours) or emergency (non-elective) surgery
* ASA Physical status Classification 4 to 5. (4 - patients with severe systemic diseases that is a constant threat to life, 5 - Moribund patients who are not expected to survive without the operation)
* Anticipated difficult airway requiring technique other than direct laryngoscopy for intubation of the trachea.
* Pregnancy
* History of allergic reaction to Methylene Blue medication
* Methemoglobinemia, glucose-6-phosphate dehydrogenase (G6PD) deficiency
* History of symptomatic chronic obstructive pulmonary disease (asthma, bronchitis, emphysema) or recent pneumonia (\< 6 months prior to surgery).
* Hypoxemia (hemoglobin oxygen saturation \< 90% room air or on O2 at home or in hospital)
* History of coagulopathy, IV heparin therapy, or coumadin therapy (INR \> 2.5)
Vaginal Bromocriptine for Treatment of Adenomyosis

Adenomyosis is a rare non-malignant disease of the uterus that causes significant symptoms including heavy menstrual bleeding and pelvic pain. The only widely accepted treatment for adenomyosis is hysterectomy. The investigators will use a dopamine agonist, bromocriptine, as a therapy based on animal models of the disease and our prior clinical research to observe any objective improvement in the extent of the disease using Magnetic Resonance Imaging (MRI)and standard measurements for other gynecologic diseases to measure symptomatology.

Women with adenomyosis proven with MRI will be considered for the intervention with bromocriptine. They will be reassessed at 1, 6 and 9 months. Patients will get a stipend for each visit they complete. The study will end for the enrolled subject at 9th month follow-up

Eligibility Criteria:
Inclusion Criteria:

1. Women able to give informed consent and willing and able to attend all study visits
2. Premenopausal women at least 25 years of age
3. No evidence of High Grade SIL by pap smears or HPV testing within institutional guidelines
4. MRI or ultrasound imaging consistent or highly suggestive of adenomyosis
5. Use of barrier contraception, sterilization or sexual abstinence

Exclusion Criteria:

1. Women actively trying for pregnancy, currently pregnant, less than six months postpartum or breastfeeding
2. Uterine size \> 20 weeks
3. Active pelvic infection or current use of intrauterine contraceptive device
4. Current use of GnRH agonists or antagonists, or contraceptive steroids
5. MRI suggestive of malignant disease of uterus, ovary, or cervix
6. Hypersensitivity to bromocriptine or ergot alkaloids
7. History of gastrointestinal ulcers
8. History of syncope, syncopal migraine or seizure
9. Uncontrolled hypertension
10. History of myocardial infarction, uncontrolled hypertension, heart valve disorder or cerebrovascular accident
11. History of diabetes mellitus except gestational diabetes
12. History of Parkinson's Disease
13. History of psychosis
14. History of pleural or pericardial effusion
15. History of pulmonary fibrosis or thickening of the pleura
16. History of lactose intolerance
17. History of Reynaud's Disease
18. Use of opioid pain medications
Major Liver Resection: Early Clotting Disorders and Functional Impairment.

The aim of this study is to evaluate early clotting disorders through thromboelastogram and anticoagulant proteins levels (maybe also endothelial markers) and liver function by indocyanine green clearance after major liver resection and search for a potential relationship between them.

We are prospectively recording data from patients undergoing major liver resection. We obtain a full procoagulant and anticoagulant profile preoperatively and, at first, second and sixth day after surgery. We also measure indocyanine green (ICG) clearance preoperatively and in the first two postoperative days. We are also recording clinical data, focusing on medical and surgical complications. We aim to establish the potential value of ICG clearance and or coagulation profile to predict clinical complications

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing major liver surgery defined as resection of 3 or more hepatic segments

Exclusion Criteria:

* Indocyanin green allergy
* Thyrotoxicosis
* Thrombophilia
* Lupus anticoagulant
* Coagulation factor deficiency
* Venous thromboembolism in the last 3 years
* Pulmonary thromboembolism in the last 3 years
Short-term Safety, Efficacy and Mode of Action of Apremilast in Moderate Suppurative Hidradenitis

Study design: A double-blind randomised placebo-controlled trial

Intervention: Randomized placebo controlled treatment of 20 HS patients of which fifteen patients will be randomized to apremilast and five patients to placebo. The total duration of the treatment period per subject is 16 weeks.

Primary objectives: To evaluate the expression profile of inflammatory cytokines in HS lesional skin at week four (t=4) and week sixteen (t=16):

* of patients receiving apremilast compared to placebo;
* within both groups relative to baseline (t=0).

Secondary objectives:

* To prospectively evaluate the clinical efficacy of apremilast.
* To assess the effect of apremilast on patient reported outcomes measures.
* To assess the short-term safety and tolerability of apremilast in patients with hidradenitis suppurativa.

Rationale:

Hidradenitis suppurativa (HS) is a chronic, inflammatory, recurrent, debilitating skin disease. It is characterized by painful, deep-seated, inflamed boils in the inverse areas of the body, most commonly the axillae, inguinal and anogenital regions.

Systemic therapy with immunosuppressive agents (systemic corticosteroids, dapsone, cyclosporin) has been investigated in the past decades and has shown limited efficacy. The use of the selective immunosuppressant apremilast has not yet been evaluated in HS. The investigators hypothesize a beneficial effect of apremilast in HS patients, similar to the efficacy of apremilast in psoriasis patients. Namely, it has been shown that the immune dysregulation in the pathogenesis of HS shows many similarities with that of psoriasis. Moreover, the TNF-α blocker adalimumab was registered for HS after approval for the treatment in patients with psoriasis.

Eligibility Criteria:
Key inclusion criteria:

* Adult (≥ 18 years of age) male or female patients with moderate HS according to a PGA of 3 on the 5-point HS-Physician Global Assessment (HS-PGA);
* HS of more than 6 months duration; have lesions in at least two anatomical locations.

Key exclusion criteria:

* Contra-indication for apremilast; previous use of apremilast; have any current and/or recurrent clinically significant skin condition in the treatment area other than HS;
* Presence of other uncontrolled major disease;
* Pregnant or lactating women.
Effect-site Concentration of Propofol for I-gel Insertion During Anesthesia Induction With a Single-dose Dexmedetomidine

Before anethetic induction, infuse dexmedetomidine 0.5 mcg/kg for 2 minutes and after injection of lidocaine 30 mg, propofol infusion by using target controlled infusion (TCI) pump. Effect site concentraion of propofol start from 5 and changes the concentration as previous response to i-gel insertion as up and down methods

Before anethetic induction, infuse dexmedetomidine 0.5 mcg/kg for 2 minutes and after injection of lidocaine 30 mg, propofol infusion by using target controlled infusion (TCI) pump. Effect site concentraion of propofol start from 5 and changes the concentration as previous response to i-gel insertion as up and down methods. Failure of previous subjects are defined as difficulty to mouth open, severe nausea and couph and laryngeal spasm, and not loss of consciousness.

Eligibility Criteria:
Inclusion Criteria:

* ASA PS I-II, 20-60 yrs old

Exclusion Criteria:

* predicted difficulty airway, recent URI, BMI \> 30kg/m2, reactive airway disease
Clinical Outcomes From Nalmefene

The purpose of this study is to assess the effectiveness of nalmefene relative to naloxone for the reversal of opioid intoxication in emergency department (ED) settings.


Eligibility Criteria:
Inclusion Criteria:

1. Presumed or known opioid overdose in community settings.
2. Experiencing clinically significant respiratory depression based on appropriate medical judgement.
3. Patient airway is open and unobstructed at the time of enrollment. (Utilization of oral pharyngeal or nasal pharyngeal airway is allowed.)
4. Pre-hospital naloxone administration is allowed.

Exclusion Criteria:

1. Patient age known or estimated to be less than 18 years.
2. Patient has one or more additional documented acute medical, traumatic, toxicologic, or psychiatric conditions that would extend length of treatment or adversely alter the clinical outcome.
3. Cardiac arrest, secondary to opioid intoxication.
4. Arrested, jailed, or imprisoned patients.
5. Inappropriate for the study per judgement of research team.
The Effect of Remote Ischemic Preconditioning on the Ischemic Reperfusion Injury in Infants With Ventricular Septal Defect and Pulmonary Hypertension

Intraoperative myocardial and pulmonary protection is important for better outcome after cardiac surgery. Ischemic preconditioning is one of organ protective strategies against ischemia-reperfusion injury by applying brief ischemia to the target organ before a subsequent critical ischemia, and its effect has been confirmed. However, its clinical application is not easy because ischemic insult may aggravate the function of vulnerable organ.

On the other hand, remote ischemic preconditioning (RIPC) is another protective approach by applying ischemia to other less vulnerable organ such as skeletal muscle before critical ischemia-reperfusion injury to heart. The effect of RIPC has been well demonstrated in adults and children. However, Little is known about the effect of remote ischemic precondition on the pediatric myocardium to ischemia and reperfusion injury. The effect of RIPC on the children remains to be further evaluated because the degree of ischemia-reperfusion injury is different according to age, cardiac pathology and cyanosis. In addition, the previous report on children dealt with a diverse range of congenital heart defects with a wide age range. The purpose of this study was to evaluate the effect of RIPC on myocardial and pulmonary protection in infants with pulmonary hypertension who need repair of simple ventricular septal defect.


Eligibility Criteria:
Inclusion Criteria:

* perimembranous or muscular outlet or muscular inlet ventricular septal defect
* pulmonary hypertension (+)
* infant (\<1 year)

Exclusion Criteria:

* subarterial ventricular defect
* chromosomal defect
* airway or parenchymal lung disease
* blood disorder
* anticipation of cardiac muscle resection
Primary Care and Parenting

The objective of this study to evaluate potential impact of a brief, low-cost primary care-based intervention of parenting self-efficacy, knowledge, and behavior.

Enriching parenting behaviors in early childhood promotes child development and offers a promising strategy to reduce future educational disparities. However, current interventions are limited by cost and have not been widely disseminated. Recognized as a target for research to improve early childhood development and subsequent school readiness skills among at-risk families, the primary care setting offers an ideal opportunity to reach the millions of children living in poverty. However, what remains unknown is how to more efficiently leverage the primary care setting to deliver a sustainable and effective preventive program to promote positive parenting behaviors and encourage early childhood development in low-income families. Therefore, the investigators designed Sit Down and Play (SDP) a brief parent-directed program delivered in the primary care setting. Modeled after the widely disseminated literacy program Reach Out and Read and grounded in social cognitive theory, SDP is intended to take place during each pediatric well-child visit occurring in a child's first two years with the goal of promoting positive parenting behaviors.

Eligibility Criteria:
Inclusion Criteria:

Parent is 18 years or older Child is present for a 6, 9, or 12 month well-child visit who attends University of Illinois at Chicago (UIC) for well-child care Adult present with child at appointment is parent/caregiver of child

Exclusion Criteria:

Parent is non-English speaking Child is acutely sick