cyrilzakka/clinical-trials huggingface dataset:
Surveillance and Tracking the Outcomes of Chronic Latent EBV Infection

Immunocompetent subjects with high load of Epstein-Barr virus DNA (EBV-DNA) in peripheral blood will be enrolled and prospectively followed up to track the natural histories of the chronic high load of EBV virus. The primary goal of this study is to explore the association of peripheral high load of EBV with the hematological malignancies, and second goal is to investigate the genetic mechanisms of immune escape and tumorigenesis of chronic EBV infection.

Epstein-Barr virus (EBV) is an oncogenic virus implicated in the pathogenesis of a variety of human hematological malignancies such as lymphomas, hemophagocytic lymphohistiocytosis and chronic active EBV disease. While chronic latent EBV infection（especially carriers with persistent high load of EBV-DNA copy number）is the gray zone between the primary infection and the hematological malignancies, which is rarely concerned. Previous work has prompted the heterogeneities of EBV infection, such as racial heterogeneity, viral load heterogeneity and heterogeneity of infected target cells. It is of great significance to prospectively track the transforming process and elucidate the association of chronic EBV infection and hemophagocytic lymphohistiocytosis. Healthy subjects who was found to have high EBV-DNA load （\>1×103 copies/ml）in peripheral blood during the physical examination were enrolled and followed up by telephone or face-to-face interview periodically. The primary outcome is hematological malignancies including Burkitt lymphoma, EBV+ B-cell lymphoproliferative diseases, extranodal NK/T-cell lymphoma of nasal type (ENKL), aggressive NK-cell leukemia (ANKL), classic Hodgkin lymphoma,EBV-associated hemophagocytic lymphohistiocytosis and Chronic active Epstein-Barr virus infection (CAEBV). The Exploratory purpose of this study is to investigate of genetic mechanisms of immune escape and tumorigenesis of EBV infection. Subgroup analysis will performed in subjects with mild high load (\>1×103 copies/ml and \<1×104 copies/ml) and severe high load (\>1×104 copies/ml) of EBV-DNA copies.

Eligibility Criteria:
Inclusion Criteria:

1. immunocompetent subjects who was found to have high EBV-DNA load （\>1×103 copies/ml）in peripheral blood during the physical examination
2. Willing to be followed up by telephone or face-to-face interview

Exclusion Criteria:

1. Subjects with defined immunodeficiency
2. Subjects who have taken or are going to take immunosuppressive drugs.
3. Subjects Diagnosed a validated hematopathy
4. Subjects diagnosis as precancerous lesion or malignant tumor and the life expectancy is less than 1 year.
5. psychological illness which does not allow subjects to understand the study and participate following his own free will
6. Pregnant woman
7. no written informed consent
A Pharmacokinetics Study Comparing PF-06438179 and Infliximab in Healthy Volunteers (REFLECTIONS B537-01)

In this study, healthy volunteers will receive a single intravenous dose of either PF-06438179 or infliximab (United States) or infliximab (European Union). During the course of the study, the pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms of PF-06438179 and the licensed infliximab products. Safety, tolerability, and immunologic response will also be evaluated throughout.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female subjects of non-childbearing potential and healthy male subjects (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 32.0 kg/m2; and a total body weight \>50kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant infectious, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, autoimmune, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Previous exposure to a monoclonal antibody, or current use of other biologics.
* History of hypersensitivity reaction to inactive components of the study drugs or any murine proteins or anaphylactic reactions to therapeutic drugs.
* History of tuberculosis (TB) or a positive latent TB test at Screening.
Role of Positron Emission Mammography (PEM) Flex Solo II Positron Emission Tomography (PET) Scanner in Evaluating Neoadjuvant Chemotherapy Response in Patients With Breast Cancer

The purpose of this study is:

1. To evaluate the hypothesis: Can PEM Flex Solo II PET scanner ascertain response to neoadjuvant chemotherapy in patients with breast cancer?
2. To compare the results from the PEM Flex Solo II PET scanner to the standard of care bilateral breast MRI.

Subjects will receive bilateral (both sides) breast and axillary PEM scans. All recruited subjects chosen for the study will have biopsy proven breast cancer and are eligible for chemotherapy. They will undergo bilateral breast MRI for staging which is considered standard of care. Breast MRI and PEM scans will be performed at at baseline (phase 0 or pre-operative phase), 2nd MRI and PEM after 1 to 2 weeks of NAC (phase 1) and 3rd MRI and PEM after 1 to 2 weeks of phase 1 (phase 2). DCE-MRI and PEM will be performed not more than 14 days apart within each phase. Cranio-Caudal (CC) and Medial Lateral Oblique (MLO) PEM views will be performed of both the ipsilateral and contralateral breast and axillae by a Mammography Technologist trained in mammographic positioning.

Eligibility Criteria:
Inclusion Criteria:

* Women 18-75 years old with newly diagnosed breast cancer who are considered candidates for breast conserving surgery (i.e., lumpectomy)

Exclusion Criteria:

* Children (\< 18 years old)
* Pregnant or Lactating women
* Diabetic patients (Type I or II)
* Patients who are scheduled for a sentinel node procedure using radioactive Tc-99m within 24 hours of PEM
* Patients who have NOT undergone a standard of care bilateral breast MRI
Take-home Functional Electrical Stimulation for MDD

The purpose of this study is to learn whether Functional Electrical Stimulation (FES) of the facial muscles is effective in treating major depressive disorder (MDD) and to develop a model for take-home delivery.

A potential novel intervention for major depressive disorder (MDD) is bilateral functional electrical stimulation (FES) of the facial muscles. The portable FES stimulator delivers electrical current to excitable tissues. Based on the preliminary work, FES can elevate mood in healthy subjects and reduce anxiety symptoms in MDD patients. The proposed study will develop a viable prototype for a "take-home" FES device and evaluate the feasibility, tolerability, and safety of FES for participants with MDD.

This is a single-site, pilot, double-blind, randomized, sham-controlled clinical trial. The trial will evaluate the feasibility, tolerability, and safety of 20 FES sessions (over 4 weeks) for MDD. Additionally, data on the preliminary therapeutic effects of 20 FES sessions for the symptoms of MDD and associated anxiety, quality of life, and sleep will be collected.

Eligible participants enrolled in this clinical trial will have a total of 28 visits. There will be 1 screening visit which will take place over the phone, 3 on-site visits (including 1 mask development visit, 1 mask delivery visit, and the last follow-up visit), and 24 Online visits (to take place over videoconference on the Zoom platform); One baseline Visit, 20 days of the FES treatment sessions, and three post-stimulation visits.

Eligibility Criteria:
Inclusion Criteria:

1. Meet the DSM-5 criteria for unipolar MDD with a current major depressive episode (MDE) without psychotic features, with ≤ 2 failed treatment trials (non-treatment-resistant depression), as determined by a physician and validated by a MINI done by a trained research assistant
2. No change in the medication regimen or other forms of treatments (e.g., psychotherapy) for at least 4 weeks (28 days) prior to beginning the study, during the 20-session treatment period, and the 4-week post-treatment observation period. This will be established through self-report, in combination with the Antidepressant Treatment History Form (ATHF) form filled out by the participant.
3. Men and non-pregnant women aged \> 18 years

Exclusion Criteria:

* 1. Paralysis of facial nerves

  2. Metallic implants or metal braces near the potential sites of electrical stimulation and any type of implanted electronic device

  3. Current fibromyalgia or currently receiving or have received repetitive transcranial magnetic stimulation (rTMS) within the last month (28 days) before screening

  4. Past or current symptoms of mania, hypomania, mixed episodes, psychotic disorders, active substance abuse, or dependence (excluding nicotine and caffeine) which will be confirmed on the MINI done by a trained research assistant

  5. Current suicidal intent or plan as demonstrated by a score of ≥ 2 on MADRS item 10
A Randomized, Double-Blind, Placebo-Controlled Trial of Flumazenil for the Treatment of Obsessive Compulsive Disorder

The purpose of this study is to evaluate the efficacy of flumazenil in the outpatient treatment of Obsessive Compulsive Disorder (OCD).


Eligibility Criteria:
Inclusion Criteria:

* Able to understand and provide written informed consent.
* Age 19-60, inclusive.
* Diagnosis documented according to DSM-IV of OCD.
* Exhibits moderate to severe OCD symptoms and a minimum score of 16 or greater -YBOCS at screening.
* Willing and able to discontinue current medications taken for the treatment of OCD.
* Able to attend and participate in all study visits.
* Agree to continue if in current psychosocial therapy throughout the remainder of the study.
* If female and of child-bearing potential, willing to use an acceptable method of birth control for the duration of the study.
* If male, willing to use barrier method of birth control or had previous vasectomy.

Exclusion Criteria:

* Have other DSM-IV Axis I diagnoses.
* Pregnant as confirmed by urine analysis, or lactating, or unwilling to comply with use of contraception.
* Unwilling or unable to washout (discontinue) from prohibited medications such as antidepressants (See Appendix 2).
* Depression symptoms with a score of 15 or greater on the MADRS at screening.
* Current suicidal ideation or plan within the last 30 days.
* Have a medical condition which, in the opinion of the investigator, makes study participation unsafe or noncompliant.
* Abnormal physical exam or laboratory values which, in the opinion of the investigator, makes study participation unsafe or may require introduction of concomitant medications during the course of the study.
* Benzodiazepine and/or similar sedative-hypnotic or anxiolytic use or abuse within 15 days of potential flumazenil treatment: patients must not be habituated to benzodiazepines and must provide a urine sample that is negative for benzodiazepines, must not be taking supra-therapeutic doses of zolpidem (AmbienTM) or zaleplon (SonataTM ). (See Appendix 2).
* Patients who are taking Phenobarbital for a documented seizure disorder can be admitted. Patients with a seizure disorder being managed with clonazepam (KlonopinTM ) or other benzodiazepine cannot participate, patients must not be taking TCA, lithium, methylxanthines, isoniazid, propoxyphene, monoamine oxidase inhibitors, bupropion HCL, and cyclosporine. (See Appendix 2).
* Previously treated with flumazenil for OCD.
* AIDS as determined by self-report.
"Quick-starting" of a Quadriphasic Contraceptive Pills, 1 - 3 mg Estradiol Valerate/ 2 - 3 mg Dienogest VS 20 mcg Ethinylestradiol/75 mcg Gestodene Focusing on Ovulation Inhibition

The goal of this clinical trial is to learn if Estetrol/Drospirenone inhibit ovulation in quick-starting method. It will also learn about the safety of Estetrol/Drospirenone. The main questions it aims to answer are:

Does Estradiol valerate/Dienogest inhibit ovulation inferior to Ethinyl estradiol/Gestodene when starting on Day 7-9 of menstrual cycle? What are the impacts of Estradiol valerate/Dienogest on ovarian activities when starting on Day 7-9 of menstrual cycle? How does the cervical mucus change when starting Estradiol valerate/Dienogest on Day 7-9 of menstrual cycle? What are the adverse effects when starting Estradiol valerate/Dienogest on Day 7-9 of menstrual cycle? Researchers will compare Estradiol valerate/Dienogest to Ethinyl estradiol/Gestodene to see if Estradiol valerate/Dienogest inhibit ovulation in quick-starting method.

Take Estradiol valerate/Dienogest or Ethinyl estradiol/Gestodene starting on day 7-9 of menstrual cycle then every day for 1 pack of the pills.

Visit the clinic on day 1-2, day 7-9, and then every 2-7 days according to ultrasound finding (ovarian activities) until completing of pills to investigate

* Transvaginal ultrasound
* Cervical mucus
* Serum hormonal profiles.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 - 45 years old
* Body mass index 18-30 kg/m²
* Menstrual interval within 24 - 38 days
* Absence of history of estrogen or progestin allergy and Absence of these compatibles with U.S. medical eligibility criteria category 3 - 4
* Consent to use condom as contraception or have been sterilized

Exclusion Criteria:

* History of estrogen, progestin or testosterone use within 3 months
* Current pregnant or within 3 months of breastfeeding
* Having ovarian cyst(s) or tumor(s)
* Being a cervical cancer patient or having precancerous cervical lesion
Motor Cortex Stimulation for Chronic Neuropathic Pain

The purpose of this study is to evaluate the efficacy of cortical stimulation (CS) as an adjunctive treatment for chronic neuropathic pain.

Prospective, controlled, double blind, randomized, crossover study with endpoint evaluations at the end of each 3-month treatment period.

An interim analysis will be conducted by a blinded committee when approximately half of the patients have finished the study.

Eligibility Criteria:
Inclusion Criteria:

* Men and women (non-pregnant) age 21-70 years;
* Able to give informed consent in accordance with institutional policies;
* Diagnosis of chronic neuropathic pain according to the DN4 Neuropathic Pain Diagnosis scale (score ≥ 4).
* Documented pain for at least 12 months;
* Documented previous or current treatment for neuropathic pain with medications from at least two of the following groups at adequate doses: antidepressants, anticonvulsants, and/or gabapentinoids;
* VAS scores of at least 6 during baselines #1 and 2.
* Documented clinical diagnosis of neuropathic pain associated with one of the following conditions: facial pain, post-stroke pain, brachial plexus avulsion, or phantom limb pain of the upper extremities.
* In the group with post-stroke pain, only patients with predominant face and upper extremity pain will be included. This will be defined as a difference of ≥ 30% or ≥ 2 points in VAS scores between these regions and lower extremity (in patients who also have pain in the leg).
* No change in current neuropathic pain medication regimen for at least 4 weeks prior to study enrollment.
* Able to comply with all testing and follow-up requirements as defined by the study protocol.
* Must be determined medically stable by surgeon to undergo cortical stimulation surgical procedure.

Exclusion Criteria:

* Alcohol, medication, or illegal substance dependence or abuse within last 12 months;
* Trigeminal neuralgia or atypical facial pain.
* Post-stroke pain predominantly in the lower extremity.
* Advanced cardiovascular disease which renders anesthesia and surgery as unsafe as determined by neurosurgeon;
* Clinically relevant abnormality (e.g. tumor) on study MRI;
* Has cardiac pacemaker/defibrillator or other implanted active stimulator;
* Has a medical condition requiring a repetitive MRI body scan;
* Requires chemotherapy for the treatment of malignancy or requiring chronic oral or intravenous, immunosuppressive, or steroid therapy;
* Is unable to comply with study visit schedule and timeline;
* Past ablative or relevant intracranial surgery;
* A female lactating or of child bearing potential, with a positive pregnancy test or not using adequate contraception;
* Other medical conditions likely to require hospitalization within the next year.
Appointment Intervals and Orthodontic Tooth Movement

The purpose of this study is to investigate rapidity of tooth alignment in a randomised clinical trial of orthodontic patients allocated randomly into two different appointment intervals groups. First group will be reviewed every two weeks to adjust their braces while the second group will be reviewed every 8 weeks.

Orthodontics is a branch of dentistry concerned primarily with the correction of dental crowding or tooth malalignment. The first phase of fixed appliance orthodontic treatment is concerned with tooth alignment and relies upon a rapid and predictable response of the appliance system to the forces applied by the aligning archwire. The appropriate length of time between orthodontic appointments, generally called the 'appointment interval', has been the subject of debate for many years. Doctors all have their own preferences, based either on what they were taught in their orthodontic specialty programs or on community norms. Little evidence has been presented in the orthodontic literature to support these biases. The appointment interval may influence tooth alignment rates and treatment time along with other variables, such as periodontal status. Accelerating orthodontic tooth movement can significantly reduce treatment duration and the risk of side-effects.

Eligibility Criteria:
Inclusion Criteria:

Subjects should:

1. be aged 12-18 years old;
2. present with a crowded lower arch that requires orthodontic tooth alignment with a fixed appliance;
3. be medically fit and healthy (absence of systemic diseases);
4. have normal weight (according to body mass index measurements BMI);
5. have permanent dentition;
6. have lower incisor irregularity of 5-12 mm;
7. not having complete overbite;
8. be either extraction or non-extraction cases;
9. be able to give informed consent.

Exclusion Criteria:

1. Subjects who have received fixed orthodontic treatment before.
2. Subjects who will be participating in any other intervention trials.
3. Subjects with reported nickel allergy.
4. Subjects who have received antibiotic therapy in the previous six months, or who have any history of juvenile periodontal disease.
5. Subjects who have lower incisor extracted tooth.
Use of Screening Colonoscopy Among Minority Women and Men

Colorectal cancer is a cancer in the colon or rectum. Routine screening can find it at an early stage, when it has a much higher chance of cure. Screening can also help to find polyps. These are mushroom shaped growths that could turn into cancer. A polyp can be removed before it turns into cancer. Even though screening can save lives, not enough people in the country are having it. This is especially true in Harlem. Harlem has a higher rate of deaths from this cancer than other places in the U.S. because too many people do not get screened. By the time a person has symptoms, the cancer may be at a late stage, when it is much harder to cure.

We are doing this study to see if we can increase the number of people in Harlem who get screened. We plan to tell women about the screening when they have a mammogram or pap test. We will also ask them what they know and think about colorectal cancer. And, we will see if they get other members of their household to be screened.


Eligibility Criteria:
Inclusion Criteria:

* Age \> or equal to 50
* Availability by telephone

Exclusion Criteria:

* History of colorectal cancer screening (fecal occult blood testing annually for last 3 years; colonoscopy within the last 10 years)
* History of colorectal cancer
* Serious illness which precludes colonoscopy (severe heart disease; severe pulmonary disease; uncontrolled diabetes; uncontrolled hypertension; other medical contraindication)
Comparing Minimal Invasive Surgery en Conventional Total Knee Arthroplasty

Randomized clinical trial comparing minimal invasive operating technique to conventional operating technique for placement of total knee prosthesis.

Clinical evaluations, patient questionnaires, X-rays and CT scans were done to compare these two techniques.

Study executed with 3 centers and 69 patients.

Eligibility Criteria:
Inclusion Criteria:

* patient requiring Total Knee Arthroplasty (TKA)
* patients with Osteo arthritis
* intact collateral ligaments and patella tendon
* patients willing and able to comply with the post-operative schedule

Exclusion Criteria:

* patients who require a revision TKA
* patients with TKA contralateral knee within 6 months with bad outcomes
* patients who need a TKA on contralateral side within 2 years
* intraoperative resurfacing of patella
* intraoperative eversion of patella
* patients who had prior procedure of involved knee such as high tibial osteotomy, cruciate ligament recontruction, knee fusion or patellectomy
* BMI \> 30
* patients with fixed flexion contracture\> 15 degrees
* patients with deformity greater than 20 degrees of varus or 15 degrees of valgus
* Patient with Mediolateral stability \> 10 degrees patient with active or suspected malignancy
* patient with Rheumatoid arthritis
* patient with systemic disease that would effect subject's wellfare or overall outcome of the study
* patient with other severe concurrent joint involvement which can effect their outcome
* patients with an immobile hip
* patient with a history of Pulmonary embolism or Deep venous thrombosis
Pilot Study of a New Medical Food in the Management of Ulcerative Colitis

The goal of this clinical trial is to determine at how well a new medical food works in managing inflammation associated with ulcerative colitis in children. The main question it aims to answer is:

1) How well does the new medical food lower an inflammatory biomarker known as fecal calprotectin (fCal) in ulcerative colitis as compared to the historical active therapy levels of fCal? Participants will take a specified dose of the medical food in water each day for 12 weeks. The level of fCal will be measured through a stool sample at baseline, one during the 12 weeks, at the end of 12 weeks, and once more at 16 weeks. The levels of fCal will be compared across the 16 weeks and compared with levels before the new medical food was taken.

The objective of this clinical trial is to assess the physiological response to a biologic food substance in maintenance therapy for ulcerative colitis in children. This will be measured through the measurement of fecal calprotectin (fCal) levels across the study period as well as in comparison to historical active therapy levels. Secondary endpoints will include a variety of biologic markers (inflammatory, microbial, metabolic) as well as clinical scores including patient reported outcomes and serum-based biomarkers such as ferritin and hemoglobin. The aim is to evaluate the effectiveness of the medical food as a safe and well-tolerated non-pharmacologic approach for reducing dependence on drug therapies and their associated side effects in the treatment of ulcerative colitis.

Eligibility Criteria:
Inclusion Criteria:

Pediatric patients with a confirmed diagnosis of ulcerative colitis on stable maintenance therapy.

Exclusion Criteria:

Pediatric patients with a confirmed diagnosis of ulcerative colitis who utilize oral or topical corticosteroids in maintenance therapy.