cyrilzakka/clinical-trials huggingface dataset:
Xolair (Omalizumab) for Treatment of Drug-induced Acute Tubulointerstitial Nephritis (AIN)

The investigators goal is to evaluate the role of XOLAIR® in treatment of Acute Tubulointerstitial Nephritis (AIN) with the goal of shortening the duration and dose of prednisone for treatment of drug-induced AIN. Currently there is no good treatment for drug-induced AIN. Prednisone is the standard treatment but is associated with many side-effects when used long-term and at high doses.


Eligibility Criteria:
Inclusion Criteria:

1. Adult subjects \> 18 years old of both genders
2. Biopsy proven acute interstitial nephritis in the native kidneys without evidence of ischemic or glomerular pathology in the biopsy
3. Normal baseline creatinine defined as estimated GFR ≥ 60 ml/min/SA based on MDRD calculation within 1 year prior to renal biopsy
4. Serum creatinine elevation of \> 0.3 mg/dL and/or doubling of serum creatinine compared to most recent documented creatinine available (at least within the last year)
5. No immunosuppressants in the last three months including prednisone
6. Women of childbearing potential not using the contraception method can be included as this is a one time dosing and has no known long-term effects.

Exclusion Criteria:

1. Unwillingness to give consent
2. Patients who are Pregnant (positive serum pregnancy test for females) or breast feeding
3. Documented history of an autoimmune disease
4. Inability or unwillingness to take prednisone for the prescribed duration and/or dose
5. Subjects suspected to have non-drug-induced AIN
6. Subjects not meeting the inclusion criteria
7. Subjects with contraindication to administration of omalizumab
8. Prior use of omalizumab
9. Severe hypersensitivity to omalizumab or any component of the product
10. Known elevated IgE level from other disease processes
11. Subjects taking (nonsteroidal antiinflammatory drug) NSAIDs chronically
12. Use of any other investigational agents in the last 30 days
13. Patients with severe medical condition(s) including metastatic cancer, terminal congestive heart failure, severe ischemic heart disease or any other medical condition in which life expectancy is less than 6 months.
Effect of Gymnema Sylvestre on Metabolic Syndrome and Insulin

Gymnema sylvestre has demonstrated promising effects in the treatment of obesity, dyslipidemia, hypertension, insulin secretion, among others. The above mentioned findings show that Gymnema sylvestre has an excellent potential for the prevention and treatment of metabolic syndrome.

A randomized, double-blind, placebo-controlled clinical trial was carried out in 24 patients with a diagnosis of metabolic syndrome in accordance with the modify International Diabetes Federation criteria. The patients received 300 mg capsules of Gymnema sylvestre or placebo, two times daily before breakfast and dinner for 90 days. Before and after intervention the investigators evaluated: The components of metabolic syndrome (waist circumference, triglycerides, high-density lipoprotein, fasting glucose and blood pressure), body weight, body mass index, total cholesterol, low-density lipoprotein, very-low-density lipoprotein, creatinine, aspartate transaminase and alanine transaminase.

Were calculated: Areas under the curve of glucose and insulin were calculated with de Trapezoidal formula. Total insulin secretion was evaluated with the Insulinogenic index and the insulin sensitivity was estimated using the Matsuda index.

Eligibility Criteria:
Inclusion Criteria:

* Letter of consent and release signed by each patient
* Body mass index: 25-34.99 kg/m2
* Body weight without variations above or under 5% during the three months prior to the study
* Diagnostic of metabolic syndrome according to the modified International Diabetes Federation definition: Central obesity (defined as waist circumference ≥ 80 cm in women and ≥ 90 cm in men)

Plus any two of the following four factors:

* Triglycerides: 150-499 mg/dL.
* High density lipoprotein: Woman \< 50 mg/dL, man \< 40 mg/dL.
* Blood pressure systolic:130-139 mmHg and/or Blood pressure diastolic: 85-89 mmHg
* Fasting glucose: 100-125 mg/dL

Exclusion Criteria:

* Type 1 or 2 diabetes mellitus
* Previous pharmacological treatment for components of metabolic syndrome
* Mental or physical illness interfering with the study
* Thyroid or cardiovascular disease
* Pregnant or suspected pregnant women
* Woman breastfeeding
* Index of body mass: ≥ 35 kg/m2
* Treatments known to affect metabolism of glucose, fats and affecting arterial tension
* Patients with hepatic or renal diseases background
* Patients diagnosed with kidneys disease
* Calcined magnesium intolerance
* Gymnema Sylvestre intolerance
Integrated Rehabilitation Program for Fractures

The recovery of range of motion and muscle power after surgical intervention of the fracture will mostly affect patient's daily activities. So postoperative rehabilitation program will play the important role. Correct and effective physical therapy will reduce the functional impairment of limbs after long term casting or surgical fixation, and accelerate to recover the independent daily activities. There is no consensus between immediate or delay and the duration of continue physical therapy will improve the shoulder function、muscle power and degree of satisfaction( physiological function、social function、mental health、 pain、 general health status ) after surgical fixation of fractures. This study will evaluate the patients of the fracture that including of the humeral neck fracture, vertebral fracture, distal radial fracture and hip fractures after surgical fixation, to see the difference of fracture healing time, function recovery and pain sensation after intervention of physical therapy at different time point.

From this study, we hope to discriminate the timing of intervention and duration of physical therapy which is the key factors for postoperative prognosis of fractures fixation, and to set up the perfect rehabilitation program in ChangHua Christian Hospital. The results of this study will improve the discomfort of fracture patient's recovery or reduce the complications rate, and set up the standard treatment policy of our hospital , also was the model of other hospitals.


Eligibility Criteria:
Inclusion Criteria:

* patients with humeral neck fracture, vertebral fracture, distal radial fracture or hip fractures after surgical fixation

Exclusion Criteria:

* no
Study Evaluating the Effects of DVS SR and Duloxetine on the Pharmacokinetics of Desipramine in Healthy Subjects

The purpose of this study is to evaluate the effects of multiple doses of DVS SR and duloxetine on the pharmacokinetics of a single dose of desipramine in healthy subjects.


Eligibility Criteria:
1. Healthy men and women between 18 to 55 years of age.
2. Healthy as determined by the investigator on the basis of medical history and physical examination, laboratory test results, vital signs and a 12-lead electrocardiogram.
3. History of being a nonsmoker for a least 1 year.
Safety and Efficacy of GX-188E DNA Therapeutic Vaccine Administered by Electroporation After Observation

This study is to follow up on the change of immune response by measuring HPV type 16/18 E6 and E7 specific T cell response and lesion condition in subjects who have administered in DNA-based therapeutic vaccine.

This is a follow-up study to investigate the change of immunogenicity and lesion condition in subjects with cervical intraepithelial neoplasia (CIN) 3 who have enrolled and participated GX-188E phase II trial(GX-188E_CIN3_P2).

Subjects will make visits 7 times for about three years from the last visit of GX-188E phase 2 trial (GX-188E_CIN3_P2).

The endpoints are to evaluate the change of immune response, involved lesion and infection status compared to that of the final visit in phase 2 trial (GX-188E_CIN3_P2).

Eligibility Criteria:
Inclusion Criteria:

* Those who voluntarily signed informed consent form
* The subjects who have participated in phase II trial(GX-188E_CIN3_P2)

Exclusion Criteria:

* The subjects who didn't receive GX-188E DNA vaccine during Phase II trial (GX-188E_CIN3_P2)
* The subjects, it is difficult to participate in this study continuously
* Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study
A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis

This is a phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex (interferon beta-1a) controlled dose finding study to evaluate the efficacy as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in participants with Relapsing Remitting Multiple Sclerosis (RRMS).


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent and to be compliant with the schedule of protocol assessments
* Relapsing-remitting multiple sclerosis (MS)
* Ages 18-55 years inclusive
* For sexually active female and male participants of reproductive potential, use of reliable means of contraception

Exclusion Criteria:

* Secondary or primary progressive multiple sclerosis at screening
* Incompatibility with MRI
* Contra-indications to or intolerance of oral or IV corticosteroids
* Known presence of other neurologic disorders
* Pregnancy or lactation
* Lack of peripheral venous access
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
* Significant, uncontrolled disease, such as cardiovascular, pulmonary, renal, hepatic, endocrine or gastrointestinal
* Congestive heart failure
* Known active bacterial, viral, fungal, mycobacterial infection or other infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks prior to screening or oral antibiotics within 2 weeks prior to screening
* History or known presence of recurrent or chronic infection
* History of cancer, including solid tumors and hematological malignancies (except basal cell, in situ squamous cell carcinomas of the skin, and in situ carcinoma of the cervix of the uterus that have been excised and resolved)
* History of alcohol or drug abuse within 24 weeks prior to randomization
* History of or currently active primary or secondary immunodeficiency
* History of coagulation disorders
* Treatment with any investigational agent within 4 weeks of screening
* Receipt of a live vaccine within 6 weeks prior to randomization
* Incompatibility with Avonex use
* Previous treatment with rituximab
* Previous treatment with lymphocyte-depleting therapies except mitoxantrone
* Treatment with lymphocyte trafficking blockers within 24 weeks prior to randomization
* Treatment with beta interferons, glatiramer acetate, IV immunoglobulin, plasmapheresis, or immunosuppressive therapies within 12 weeks prior to randomization
* Systemic corticosteroid therapy within 4 weeks prior to randomization
Propofol Versus Midazolam and Fentanyl for Diagnostic and Screening Colonoscopy in Patients With Advanced Liver Disease

Prospective, randomized-controlled trial (RCT) comparing the use of Propofol and traditional sedation (Midazolam and Fentanyl) for diagnostic and screening endoscopies in patients with liver diseases. The investigators' working hypothesis is that the use of propofol will be translated in a shorter recovery and discharge times with a higher patient satisfaction and a decrease in general complications in the context of patients with advanced liver disease.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients older than 18 and younger than 75 years with advanced liver disease, defined by the presence of liver fibrosis at least F3 and higher in the METAVIR score or with established cirrhosis (Child Pugh A, B and C)

Exclusion Criteria:

* Patients with significant cardiorespiratory disease i.e. advanced respiratory, renal and heart failure (ASA class III or higher except for patients with decompensate liver cirrhosis), obstructive sleep apnea or those with mild degree of liver fibrosis (less than F3)
Care Management for the Effective Use of Opioids

The CAre Management for the Effective use of Opioids (CAMEO) trial is a 2-arm randomized clinical trial to compare the effectiveness of pharmacological vs. behavioral approaches for chronic lower back pain. The study aims are to compare the interventions' (PHARM vs. BEH) effects on pain intensity, pain interference, function, and other pain relevant outcomes over 12 months.

The general purpose of the CAre Management for the Effective use of Opioids (CAMEO) study is to develop, test, and implement novel treatments and care delivery models that address barriers to effective pain management and that can be practicably applied in VA primary care settings for chronic low back pain (CLBP). The CAMEO trial is a 2-arm randomized clinical trial to compare the effectiveness of pharmacological vs. behavioral approaches for CLBP.

The investigators' study sample will target 272 Veterans with moderate to severe CLBP despite long-term opioid therapy. Patients from five primary care clinics at the Roudebush VA Medical Center and two community based outpatient clinics will be recruited to participate in CAMEO and randomized to one of two treatment arms. The pharmacological arm will involve guideline-concordant opioid management coupled with algorithm-based co-analgesic treatment (MED). Patients in the behavioral arm (CBT) will receive pain self-management/coping skills training. The trial will last 12-months and all participants will undergo comprehensive outcome assessments at baseline, 3, 6, 9, and 12 months.

Study Aims: Among Veterans with chronic low back pain refractory to long-term opioid therapy

1. To compare the interventions' (MED vs. CBT) effects on pain intensity and function over 12 months
2. To compare the interventions' effects (MED vs. CBT) on other relevant outcomes

   * Health-related quality of life
   * Pain Catastrophizing
   * Depression
   * Anxiety
   * Disability
   * Opioid misuse and opioid dose

Eligibility Criteria:
Inclusion Criteria:

Veterans will be eligible if they have:

* chronic lower back pain of at least moderate intensity
* pain for 6 months
* on chronic opioid therapy
* and access to a working telephone

Exclusion Criteria:

Exclusion criteria includes:

* severe medical conditions
* active psychosis
* schizophrenia
* active suicidal ideation
* pending back surgery
* moderately severe cognitive impairment
* involvement in ongoing pain trials
* and pregnant or trying to become pregnant

The investigators will exclude Veterans with an active substance use disorder (i.e., those currently in treatment), but to maximize generalizability the investigators will not exclude those with a past history of substance abuse.
The Impact of Dry Eye Syndrome on Metrics of Low Contrast Vision Before and After Meibomian Gland Expression

The study aims to determine the impact of Meibomian Gland Dysfunction (MGD) dry eye on low contrast black/white (luminance) and cone color sensitivity performance and improvement in these functions after in-house non-invasive Meibomian gland (MG) expression.

This study offers possible benefits from gland expression to patients and subjects in terms of clinical measurements and care associated with meibomian gland dysfunction impacting all age ranges. Prior studies show that these interventions improve dry eye symptoms with intent to improve vision, low contrast color, and B/W vision after intervention in this study.

Eligibility Criteria:
Inclusion Criteria:

* Individuals over the age of 18 years
* Healthy individuals with reported symptoms of dry eye such as burning, stinging, fluctuating vision, inappropriate tearing, and feelings of grittiness particularly with prolonged near work

Exclusion Criteria:

* Under the age of 18
* Individuals currently using prescription eye medications for dry eye / MGD / inflammation / Infections or any other treatments.
Genetics of Recurrent Early-Onset Depression

This nationwide study will create a DNA collection to permit qualified scientists to search for depression-related genes.

More than 750 families with at least two siblings who have experienced major depression are needed for the study. Participants will be interviewed about psychiatric and family history, and will be asked to provide a small blood specimen. The identification of predisposing genes can lead to greater understanding of the brain mechanisms involved in severe depression which can in turn lead to the discovery of new treatments.

A Certificate of Confidentiality from the federal government ensures that all information will be strictly confidential. Blood specimens are identified only by code number (not by name).

Reimbursement is provided.

Studies of patterns of major depression in families suggest that 50 to 70% of the predisposition to major depression is caused by genes. People with recurrent depression and earlier ages of onset have more relatives with depression. There are probably at least several interacting genes, rather than a single gene as in some disorders. The identification of predisposing genes is likely to lead to greater understanding of the brain mechanisms involved in severe depression. This could lead to the discovery of new treatments.

This study will create a DNA collection to permit qualified scientists to search for depression-related genes. More than 750 families with at least two siblings who have experienced major depression are needed for the study.

Participants in this study will be interviewed about psychiatric and family history, and will be asked for a small blood specimen. Interviews can be conducted in person or by telephone. For telephone interviews, blood sample collection will be arranged at a location and time convenient for the participant. Participants will also be asked for help in inviting other family members to participate. No family member will be contacted without the permission and assistance of another participating family member.

For information on a related study, please follow this link:

http://clinicaltrials.gov/show/NCT00260182

Eligibility Criteria:
Inclusion Criteria:

* Families that have at least TWO ADULT SIBLINGS (brother/brother; sister/sister; brother/sister) who have experienced major depression.
* Depression must be RECURRENT (more than one episode).
* Depression must have started at age 30 or less in one sibling, and at age 40 or less in the other sibling.

Exclusion Criteria:

* Participants cannot have Bipolar I (manic-depressive) disorder or schizophrenia.
Intern Health Study: 2020 Cohort Micro-Randomized Trial

The aim of this study is to evaluate the efficacy of gamified competition (delivered through a smartphone) for improving the physical activity and sleep of medical interns.

Due to their high-stress workloads, medical interns tend to have lower sleep and decreased physical activity. The goal of this study is to evaluate the efficacy of gamified competition (delivered through a smartphone) for improving the physical activity and sleep of medical interns. During the study, they are teamed up by programs and institutions and competes with other teams, which aim to motivate them to have more physical activity and sleep duration during their internship year.

The primary aim of this study is to investigate whether introducing competition mechanisms into mobile health (mHealth) interventions can improve a medical intern's activity-related behavioral outcomes: daily step counts and sleep duration. The first secondary aim is to assess the time-varying competition effect on their behavioral outcomes. The second secondary aim is to evaluate how social cooperation (competing within the same institution or program) moderates the effect of competition on behavioral outcomes. The first exploratory aim is to assess the competition effect on study engagement and the second exploratory aim is to evaluate the competition effect on mental outcome, mood score.

Eligibility Criteria:
Inclusion Criteria:

* Medical intern during the 2020-2021 internship year
* Downloaded app, completed consent and filled out baseline survey prior to June 16th, 2020

Exclusion Criteria:

* None
Study Assessing Safety and Tolerability of AZD8931 Alone or in Combination With Paclitaxel in Japanese Patients.

The main purpose of this study is to determine if AZD8931 can be safely administered in Japanese patients alone and in combination with weekly paclitaxel. The study will be conducted in two parts: a monotherapy and a combination part, where safe doses of study treatment will be determined.


Eligibility Criteria:
Inclusion Criteria:

* Cancer that is refractory to standard therapies, or for which no standard therapies exist (monotherapy part)
* Patients suitable for Paclitaxel chemotherapy, who are not candidates for hormonal and anthracycline therapy (combination part)
* Life expectancy more than 12 weeks

Exclusion Criteria:

* Inadequate kidney, liver, heart, gastric, lung or eye function
* Brain metastases
* Hypersensitive to paclitaxel (combination part)
Effects Of The Mindfulness Meditation Practices On Cognition

Adults with Attention Deficit Hyperactivity Disorder (ADHD) have impairments in attentional subsystems of alerting and conflict monitoring. Mindfulness meditation may lead to an improvement of these deficits, and reduces symptoms of anxiety and depression. However, the studies that demonstrated these improvements did not use a control group, nor controlled the use of medication. In the present study the investigators will examine the effects of the mindfulness practices (same protocol of 8 weekly sessions used in the study that showed positive effects in this disorder) in the performance of adult patients and healthy people (with ADHD). Cognitive performance, mood, and the quality of life will be assessed by validated questionnaires before and after treatment/standby.


Eligibility Criteria:
Inclusion Criteria:

* Portuguese as their first language;
* minimum of eight years of formal education;
* normal vision or corrected to normal and normal hearing;
* no prior experience with meditation;
* patients should be taking stable doses of methylphenidate (for at least a month) for their disorder as prescribed by their doctors.

Exclusion Criteria:

* patients with neurological and psychiatric disorders such as psychosis, obsessive-compulsive disorder or Tourette's syndrome.