cyrilzakka/clinical-trials huggingface dataset:
Dextroamphetamine as Adjunct in Cocaine/Opiate Dependent Patients - 3

The purpose of this study is to evaluate dextroamphetamine sulfate (sustained release) as an adjunct in concurrent cocaine and opiate dependent patients.

This 27-week double-blind, placebo controlled treatment is designed to evaluate dextroamphetamine sulfate (sustained release) as an adjunct in concurrent cocaine and opiate dependent patients. All subjects will receive methadone. For the treatment of cocaine dependence, subjects will receive one of 2 doses of dextroamphetamine (15 or 30mg) or placebo. After 4 weeks of treatment the dose level of dextroamphetamine is doubled (30 or 60mg). This dose is maintained for 20 weeks; during which subjects attend twice weekly visits to the clinic and receive weekly cognitive behavioral therapy. Follow up evaluations will be conducted out to 3 months post treatment. Subjects will be assisted in transferring to Houston area methadone clinics to maintain treatment for opiate dependence following treatment completion.

Eligibility Criteria:
Inclusion Criteria- Subject must:

* Exhibit cocaine and opiate dependence through a DSM-IV diagnosis as determined by SCID.
* Be between 18 and 45 years old
* Women must agree to use contraception
* Have an EKG that has been confirmed by a cardiologist
* Give a cocaine positive urine during screening - Present with evidence of opiate withdrawal

Exclusion Criteria- Subject must not:

• Have a serious medical illness including, but not limited to the following: Hypertension Significant heart disease Clinically significant cardiovascular abnormality Angina Hepatic, renal, or gastrointestinal disorders that could result in an altered metabolism or excretion of study agent

* Have any Axis I disorder that is not related to drug use
* Have current dependence on any psychoactive disorder other than nicotine
* Be on probation or parole for reasons other than those related to drug charges (ASI)
* Be pregnant or lactating
* Have been in any outside treatment in 3 months
Serum Preptin Level and Its Relationship with Bone Mineral Disease in Chronic Kidney Disease Patients

Aim of the research:To identify preptin level and relationship with bone disease in chronic kidney disease patients.

Preptin is a 34-aminoacid peptide derived from the E-peptide of pro-insulin-like growth factor 2 (pro-IGF2) that is co-secreted with insulin and upregulates glucose-mediated insulin secretion. High serum preptin levels were described in conditions associated with insulin resistance, such as polycystic ovary syndrome and type 2 diabetes mellitus (T2M). Insulin and also IGF2 are known to be anabolic bone hormones .

Preptin stimulates osteoblastic proliferation and increases mineralization in a concentration-independent manner in osteoblast precursor cell , Despite being associated with insulin resistance, an increased fat mass has beneficial bone effects . While the increased mechanical loading favors bone formation, adipokines and also pancreatic and gut hormones were also proposed to mediate the relationship between fat and bone. The importance of nutritional hormones in maintaining bone mass was, thus, recognized. Insulin has anabolic bone effects, and hyperinsulinemia contributes to increased bone mineral density (BMD). Similar to insulin, insulin-like growth factor 1 (IGF1) and IGF2, preptin was recently proposed to have anabolic bone activity .

End-stage renal disease (ESRD) patients present with specific bone and mineral metabolism disturbances. Chronic kidney disease-associated mineral and bone disorder accounts for increased morbidity and mortality in those patients. Biochemical markers known thus far do not effectively predict the complex bone changes that are observed in ESRD patients .

Eligibility Criteria:
Inclusion Criteria:

* both sex groups of patients with age between 18-50 years . pre end stage renal disease and end stage renal disease patients .

Exclusion Criteria:

* type 2 diabetic patients
Comparison of Efficacy and Tolerability of APD Treatment With Different PD Cyclers

The study has been designed in order to investigate the performance and safety of the new Silencia PD cycler including the Silencia tubing system in comparison to the PD-Night and Homechoice PD cycler which are both well-established PD cyclers.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed and dated by study patient and investigator/authorised physician
* CKD patients being treated with APD for at least 3 months
* Minimum age of 18 years
* Body weight ≥ 40 kg
* Fluid status regularly monitored with Body Composition Monitor (BCM)
* Patients planned to change to the Silencia PD cycler
* Proper functioning catheter
* Intraperitoneal Pressure (IPP) ≤ 18 cm H2O for the maximum of TAVO parameter "permitted patient volume"
* Ability to understand the nature and requirements of the study

Exclusion Criteria:

* Patients who have any condition prohibiting the use of BCM, like patients with major amputations (e.g. lower leg)
* Patients receiving polyglucose containing PD solution
* Any conditions which could interfere with the patient's ability to comply with the study
* Patients who suffer from peritonitis/exit site infection during the last 4 weeks
* Women of childbearing age without effective means of contraception, pregnancy (pregnancy test will be conducted at start and end of study) or lactation period
* Life expectancy \< 3 months
* Participation in an interventional clinical study during the preceding 30 days
* Previous participation in the same study
Efficacy of Monthly Ibandronate in Women With RA and Reduced Bone Mineral Density Receiving Long-term Steroids

This study was to investigate the efficacy of oral monthly ibandronate in the management of glucocorticoid induced osteoporosis in women with rheumatoid arthritis.

Glucocorticoid therapy is associated with a number of significant side effects, of which bone loss resulting in glucocorticoid-induced osteoporosis and an increase in fracture risk is the most serious. However studies show that many patients treated with glucocorticoids do not receive treatment to prevent bone loss. There exist 5 large randomized controlled clinical trials providing evidence that the bisphosphonates etidronate, alendronate, and risedronate are effective in both the prevention and the treatment of glucocorticoid-induced osteoporosis. Significant increases in BMD with bisphosphonate treatment, most consistently observed in lumbar spine, were seen in patients with many different glucocorticoid-treated disorders; most often RA and polymyalgia rheumatica, and occurred generally irrespective of patient age, sex and menopausal status in women. In addition, statically significant reductions in the absolute risk and relative risk of incident radiographic vertebral fractures were demonstrated after 1 year of treatment with risedronate. A similar significant reduction in the risk of incident radiographic vertebral fractures was seen in alendronate treated patients who completed 2 years of a study of alendronate in the prevention and treatment of glucocorticoid-induced osteoporosis. There exists a data about Ibandronate which reported that intermittent intravenous ibandronate reduced vertebral fracture risk in corticosteroid-induced osteoporosis. However, there is no report about oral monthly ibandronate. Current oral bisphosphonates, which are given either daily or weekly, are associated with stringent, inconvenient dosing schedules. Less frequent dosing may provide great acceptability. The objective of this study was to investigate the efficacy of oral monthly ibandronate in women receiving long-term glucocorticoids.

Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid arthritis fulfilling the 1987 ACR criteria
* Women equal and above 18 years, less than 75 years old
* L1-4 T score less than -1.0 and equal or above -3.0 SD measured by DXA (Dual Energy X-ray Absorptiometry)
* Patient must have taken prednisolone 5mg or its equivalent for more than 3 consecutive months within 1 year
* Patient who would be taking glucocorticoids for more than 3 months after enrollment

Exclusion Criteria:

* Patient with vertebral fractures or nonvertebral fractures associated with osteoporosis
* Patient diagnosed with malignancy within 5 years
* Patient with endocrine dysfunction
* RA functional class 4
* Patient who took bisphosphonates within 6 months
* Patient on medication affecting bone mineral metabolism
Acetyl-L-Carnitine Supplementation During HCV Therapy With Pegylated Interferon-α2b Plus Ribavirin

To assess the effects of Acetyl-L-Carnitine administration on work productivity, daily activity, and fatigue in subjects with chronic hepatitis C treated with Pegylated-Interferon-α2b and Ribavirin.


Eligibility Criteria:
Inclusion Criteria:

* workers who were 18 years of age or older
* Workers who were infected by HCV and had a quantifiable serum HCV RNA level (as determined by polimerase chain reaction, COBAS AmpliPrep/COBAS TaqMan - ROCHE)
* Cirrhotic workers with a Child-Pugh score less than 7

Exclusion Criteria:

* workers who had other liver diseases
* cancer
* severe jaundice
* pulmonary and renal chronic diseases,
* prostatic diseases
* autoimmune diseases
* diabetes mellitus
* decompensated cirrhosis
* pregnancy
* cardiopathy
* hemoglobinopathies
* hemocromatosis
* major depression
* severe psychiatric pathological conditions
Epidural Analgesia Versus IV Meperidine for Labor Pain Control

60 female that care for pain control during second stage of delivery, will choose between epidural or systemic analgesia. Continuous ECG (3 lead)monitoring will be recorded during the second stage for 10 minutes. 30 minutes after administration of either pain relief, a second recording of maternal ECG will take place for 10 minutes.

Population 60 female during second stage of delivery

* Inclusion criteria : all parturients requiring pain relief will choose between systemic or epidural analgesia.
* Exclusion Criteria: all parturients with cardiac disease, neurological disease, endocrine disease, diabetes, hypertension or any parturients being treated with medications that might effect the cardiovascular autonomic system.
* Method: A 10 minute recording of a 3 lead ECG will be performed during the second stage of the delivery (3-7 CM opening).

the parturient will be lying on her left side for that period.

* 30 minutes after administration of either epidural or systemic Meperidine for pain relief, a second recording of maternal ECG will take place for 10 minutes.
* estimated duration of the procedure about one hour per woman.

Eligibility Criteria:
Inclusion Criteria: all parturients requiring pain relief will choose between systemic or epidural analgesia.

Exclusion Criteria: all parturients with cardiac disease, neurological disease, endocrine disease, diabetes, hypertension or any parturients being treated with medications that might effect the cardiovascular or autonomic system.

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Distance Savvy: Testing Tele-Savvy, a Distance Dementia Family Caregiver Education Program

The purpose of this study is to refine and test the web-based delivery of a well-established in-person group program that provides information and education to informal caregivers (family and friends) of persons with Alzheimer's disease (or related illnesses).

The pilot project proposed will allow the investigators to use telehealth methods to deliver the Savvy Caregiver, an evidence-based dementia caregiver psychoeducation program, to family caregivers of community-dwelling persons with dementing illnesses (PWD) for whom attending in-person meetings poses difficulties. The program - named Tele-Savvy - uses iPad and PC technology and on-line conferencing capacity to deliver the program through daily asynchronous self-learning modules and weekly, hour-long synchronous group meetings with program facilitators. Tele-Savvy addresses all of the learning objectives of the current in-person Savvy program (Savvy entails in-person participation in six weekly two-hour group sessions).

Eligibility Criteria:
Inclusion Criteria:

* an informal caregiver for a person with a dementing disorder, such as Alzheimer's disease
* able to speak, read, and understand English
* has access to a computer with internet connection
* lives in the US

Exclusion Criteria:

* unwilling to participate in data gathering
Effects of Vibration Stimulation Combined With Task-oriented Training on Hand Motor Function in Chronic Stroke

There is a lack of effective therapies for hand and finger function recovery in people with chronic stroke. This study assessed the effects of combining vibration stimulation with task-oriented training on functional recovery, and treatment persistence. Participants with chronic stroke underwent 24 sessions of vibration stimulation combined with task-oriented training over 12 weeks, in addition to regular therapy. Functional recovery was assessed using the Fugl-Meyer assessment for motor function (FMA-wrist and hand), the Box and Blocks Test (BBT) for hand dexterity, and the Motor Activity Log (MAL) for daily functional activities. Minimal detectable change (MDC) and minimal important difference (MID) criteria were applied to interpret changes in assessment scores.


Eligibility Criteria:
Inclusion Criteria:

* Hemiparesis after stroke
* At least 6 months post-stroke
* Aged between 20 and 80 years
* Upper extremity Brunnstrom stage IV or V
* In stable medical condition
* No cognitive deficits (able to understand and follow the instructions)

Exclusion Criteria:

* Sensory impairment which may limit the participation in vibration stimulation treatment
* Other neurological or musculoskeletal impairments
* More than 2 by the Modified Ashworth Scale (0-5)
* Skin problems that prohibit participants from wearing the vibratory gloves
* Aphasia
* Apraxia
* Received other treatments which may influence motor or sensory abilities
* Participating in other studies in the past 6 months
RD13-01 for Patients With r/r CD7+ T-ALL/T-LBL

This study is designed to explore the safety of RD13-01 for patients with CD7+ relapsed and/or refractory T cell acute lymphoblastic leukemia or lymphoblastic lymphoma. And to evaluate the efficacy and pharmacokinetics of RD13-01 in patients.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 3 to 70 years.
2. Diagnosis of r/r T-ALL/T-LBL.
3. ECOG: 0-2.
4. Life expectancy greater than 12 weeks.
5. Cardiac left ventricle ejection fraction ≥50%.
6. Informed consent explained to, understood by and signed by the patient/ guardian. Patient/guardian is given a copy of informed consent.

Exclusion Criteria:

1. Pregnant or lactating.
2. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal range; hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C Viral (HCV) RNA positive; human immunodeficiency virus (HIV) antibody positive; cytomegalovirus (CMV) DNA positive; syphilis positive.
3. Patients with graft-versus-host disease (GVHD) or who need to use immunosuppressive drugs.
4. Participated in other clinical studies within 2 weeks prior to screening.
5. History of alcoholism, drug abuse or mental illness.
6. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Parent-Adolescent Training on Neurofeedback and Synchrony

The study will test a real-time functional magnetic resonance imaging (fMRI) hyperscanning neurofeedback protocol for feasibility with ten mothers and their psychiatrically healthy adolescent daughters, with the eventual goal to test this in a sample of depressed adolescents in a future study.

This study will utilize a rigorous multi-method, multi-informant design to examine the effects of dyadic neurofeedback (dnf) on adolescent brain activation with fMRI hyperscanning. Parents and adolescents will also report on emotion regulation, depressive symptoms, and parenting practices. Data collection procedures will take place at the Laureate Institute for Brain Research (LIBR), which is equipped with two identical scanners that have advanced real-time fMRI systems capable of conducting parallel fMRI hyperscanning, including the capacity for neurofeedback. Parents will complete a phone screen to determine initial eligibility. If initial study criteria are met, a 2-hour in-person lab visit will be scheduled where mothers and daughters will complete consent/assent; diagnostic interviews; surveys on emotion regulation, parenting practices, depression, and anxiety; and additional screening. Survey data will be used for preliminary exploratory analyses. Based on data collected from the screening visit, participants will be invited to participate in the full study: a 4-hour visit where mothers and daughters will complete emotion ratings, mock scanner training, and fMRI tasks individually and together using hyperscanning (scan time = 16 min resting-state \[2 runs\], 7 min structural MRI, 40 min fMRI tasks, 10 min clinical MRI scans).

Eligibility Criteria:
Inclusion Criteria:

* Eligible for fMRI
* Sufficient English fluency to complete tasks
* BMI ≦ 40.0
* Right-handed
* Biological female
* Co-residing at least 4 days/week
* Adult participants: Biological mother of adolescent participant
* Adult participants:Primary caregiver \> 50% of child's lifespan
* Adult participants:BMI ≧ 18.0
* Adolescent participants: Age 13-17 years
* Adolescent participants: BMI ≧ 16.0

Exclusion Criteria:

* Current psychiatric diagnosis
* Medications influencing fMRI
* Medical conditions influencing fMRI
* Alcohol or psychoactive drug on scan day
* Adolescent participants: Neurodevelopmental delay
* Adolescent participants: History of mood or psychotic disorder
* Adolescent participants: History of obsessive-compulsive disorder (OCD) or attention-deficit/hyperactivity disorder (ADHD)
Study of Efficacy and Safety of Investigational Treatment in Patients With Hidradenitis Suppurativa

This is a randomized, double-blind, placebo-controlled, parallel-group phase 1b study to evaluate AT193 in approximately 44 participants with HS. The treatment period will be 8 weeks followed by a 2-week nontreatment follow-up. The primary objective of this study is to evaluate the safety and tolerability of AT193. The secondary objectives of this study are to evaluate the preliminary efficacy in the treatment of HS.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of HS or signs and symptoms consistent with HS for at least 3 months before screening in the judgment of the investigator.
* Stable disease for at least 2 months before screening in the judgment of the investigator.
* A woman of childbearing potential must use appropriate contraceptive measures during the study period.
* A woman of childbearing potential must have a negative urine pregnancy test result at screening.
* Written informed consent must be obtained before any study procedure is performed.

Exclusion Criteria:

* Pregnant or breastfeeding.
* Any active skin disease that may interfere with evaluation of study drug or outcome assessment.
* History or evidence of a clinically significant disorder, condition, or disease that would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion in the judgment of the investigator.
* Change in smoking or marijuana history within 3 months before Day 1 or planned during study period.
Sciatic Nerve Block, Adductor Canal Block, or IPACK Block

Comparison between local anesthetic infiltration between the popliteal artery and the capsule of the knee (IPACK) versus adductor canal block (ACB) or sciatic nerve block (anterior approach) in combination with femoral nerve block for postoperative analgesia in major knee surgeries.


Eligibility Criteria:
Inclusion Criteria:

* ASA I or II physical status
* undergoing elective major knee surgery

Exclusion Criteria:

* refusal of the patients to give informed consent,
* preexisting coagulation disorders,
* known allergies to aminoamide local anesthetics,
* local infection at the site of the block,
* morbid obesity,
* hepatic and renal diseases
* patients with psychological disorders
Characteristics of Patients With Recessive Dystrophic Epidermolysis Bullosa

Recessive dystrophic epidermolysis bullosa (RDEB) is a disease caused by genetic mutations in the gene for type VII collagen. Patients with RDEB develop large, severely painful blisters and open wounds from minor trauma to their skin. We are screening subjects with RDEB to evaluate characteristics of the subjects and their cells in order to develop new strategies of therapy and determine whether subjects could be candidates for treatment studies.

We will obtain a detailed medical history and will perform a skin examination and brief physical exam. Photographs may be taken. We will ask questions about the size and duration wounds.

LAB TESTS We will draw blood to determine overall health status to include Hepatitis B, Hepatitis C, and Human Immunodeficiency Virus (HIV) testing. Genetic testing may also be performed.

BIOPSIES Biopsies may be collected to check for Collagen 7 and for antibodies to Collagen 7.

Based on the results obtained, it may be possible to identify patients who would qualify to participate in current or future clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of RDEB by local dermatologist
* 7 years of age or older

Exclusion Criteria:

-Medical instability limiting ability to travel to Stanford University Medical Center
Duloxetine as an Analgesic Agent in Patients Undergoing Elective Spine Surgery

Duloxetine as an analgesic agent in patients undergoing elective spine surgery: evaluation with fentanyl demand controlled by the patient. The primary objective is to evaluate the efficacy of duloxetine in fentanyl consumption during the postoperative period of patients undergoing elective spine surgery by intervertebral disc degeneration . Secondary endpoints were pain scores and the presence or absence of adverse effects such as headache, nausea, vomiting, itching, dizziness and drowsiness.

Multimodal analgesia is widely advocated for the control of perioperative pain in an attempt to reduce the use of opioids and their side effects. Duloxetine is a selective inhibitor of serotonin and norepinephrine reuptake with demonstrated efficacy in chronic pain such as painful diabetic neuropathy and postherpetic neuralgia. The primary objective is to evaluate the efficacy of duloxetine in fentanyl consumption during the postoperative period of patients undergoing elective spine surgery by intervertebral disc degeneration . Duloxetine as an analgesic agent in patients undergoing elective spine surgery: evaluation with fentanyl demand controlled by the patient. The primary objective is to evaluate the efficacy of duloxetine in fentanyl consumption during the postoperative period of patients undergoing elective spine surgery by degenerative disc disease. Secondary endpoints were pain scores and the presence or absence of adverse effects such as headache, nausea, vomiting, itching, dizziness and drowsiness.

Eligibility Criteria:
Inclusion Criteria:

* Patients were included, of both genders, aged between 18 and 70 years and American Society of Anesthesiologists (ASA) physical status 1-3 and were eligible for the study

Exclusion Criteria:

* Patients allergics to duloxetine, ketoralac or fentanyl, pre-existing history of use of illegal substances or alcohol in an abusive manner and abnormal kidney or liver function tests.