cyrilzakka/clinical-trials huggingface dataset:
Study of Lamotrigine 2×25 mg IR Tablets of Torrent Pharmaceuticals Limited, India and Lamictal® (Lamotrigine) 2×25 mg Tablets of GlaxoSmithKline, USA, in Healthy Human Adult Subjects, Under Fasting Conditions.

* Objective:

  * A randomized, open label, two treatment, two period, two sequence, single dose, crossover, bioequivalence study of Lamotrigine 2 x 25mg IR tablets of Torrent Pharmaceuticals Limited, India and Lamictal ® (Lamotrigine) 2 x 25 mg tablets of Glaxo-SmithKline, USA, in healthy human adult subjects, under fasting conditions.
* Study Design:

  * Randomized, open label, two treatment, two period, two sequence, single dose, crossover, in 24+2 healthy human adult subjects to compare the single dose bioavailability of Torrent's Lamotrigine Tablets 2 × 25 mg and Lamictal® Tablets 2 × 25 mg of GlaxoSmithKline. Dosing periods were separated by a washout period of at least 21 days.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult subjects of either sex between 18-55 years of age (inclusive), having a body mass index (BMI) between 18 and 27 kg/m2.
* Subjects who have no evidence of underlying disease during screening and whose physical examination is performed within 21 days prior to commencement of the study.
* Subjects whose screening laboratory values are within normal limits or values outside normal limits considered by the physician/Principal Investigator to be of no clinical significance.
* Informed consent given in written form according to section 11.3 of the protocol.
* Female Subjects:

  1. of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence.
  2. postmenopausal for at least 1 year.
  3. surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).

Exclusion Criteria:

* Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
* Alcohol dependence, alcohol abuse or drug abuse within past one year.
* Moderate to heavy smoking (\> 10 cigarettes/day) or consumption of tobacco products.
* History of difficulty in swallowing tablet.
* Clinically significant illness within 4 weeks before the start of the study
* Asthma, urticaria or other allergic type reactions after taking any medication.
* Positive urine drug screening, HIV, Hepatitis B \& C tests.
* Any history of hypersensitivity to Lamotrigine.
* Existence of any surgical or medical condition, which, in the judgment of clinical investigator might interfere with the pharmacokinetics of the drug or likely to compromise the safety of the subject.
* Inability to communicate or co-operate with the investigator due to language problem, attitude, poor mental development/impaired cerebral function.
Individualized Dose Study of ATG in Haploidentical Hematopoietic Stem Cell Transplantation

The purpose of this study is to determine the response and toxicity rate of two different dosages (Individualized dosage VS. fixed dosage) of ATG as a prophylaxis for acute GVHD in haploidentical peripheral blood stem cell transplantation (haplo-PBSCT).

Acute graft-versus-host disease (aGvHD) is an important complication of haploHSCT. The Seattle group initially introduced the use of ATG as a treatment for acute graft-versus-host disease (aGVHD) in allogeneic hematopoietic stem cell transplantation (haplo-PBSCT) recipients. Presently, in both myeloablative and reduced-intensity conditioning (RIC) haplo-PBSCT, ATG is part of post engraftment immunosuppressive regimens. The regimens for prophylaxis of GVHD based on 10mg/kg rabbit anti-human thymocyte immunoglobin (ATG, Thymoglobin®, Genzyme Polyclonals S.A.S) effectively reduced the occurrence of grade II-IV aGvHD. Howevre, the incidence of cytomegalovirus (CMV) and EB virus (EBV) reactivation were higher due to a slower immune reconstitution. The 100-day cumulative incidence of CMV and EBV viremia were both over 70% in our unmanipulated haplo-PBSCT program. The optimal dose of ATG balancing the efficacy of GVHD prophylaxis and the risk of virus reactivation in haplo-PBSCT remains unknown.

Reports on the pharmacokinetics of Thymoglobulin in allo-HSCT revealed a high variability. Recent pharmacokinetic studies have shown that the half-life of total ATG after transplant is longer than the active ATG (which is available to bind to human lymphocytes and causes the desired immunological effects). And active ATG appears more associated with pharmacodynamics effects. In our previous cohort study, we found that virus reactivation and acute GVHD were highly affected by ATG exposure (area under the curve, AUC). We have found an optimal range of active ATG range is 110-148.5UE/ml.day the efficacy of GVHD prophylaxis and the risk of virus reactivation. The cumulative incidence of CMV reactivation and persistent CMV hyperemia at 180 days after transplantation in the optimal total AUC group was 60.57% and 31.52% respectively. Significantly lower than 77.08% and 56.25% in the non-optimal total AUC group.

The results suggested that Individualized dosing of ATG has a potential advantage in balancing the efficacy of GVHD prophylaxis and the risk of virus reactivation in haplo-PBSCT. This may improve the survival and quality of life of patients undergoing haplo-PBSCT. A prospective randomized trial is required to compare the efficacy of Individualized dosage of ATG as a prophylaxis for acute GVHD in haplo-PBSCT.

Eligibility Criteria:
Inclusion Criteria:

* 1. All patients should have the indication of Haploidentical hematopoietic stem cell transplant.
* 2. All patients should sign an informed consent document indicating that they understand the purpose of and procedures required for the study and be willing to participate in the study.

Exclusion Criteria:

1.Patients with any conditions not suitable for the trial (investigators' decision).
A Study To Characterize Mass Balance Of [14C] HDM1002 in Chinese Healthy Subjects

In this study, a single dose of \[14C\] radiolabelled HDM1002 will be administered orally. The main purpose of this study is to find out how much of HDM1002 and its metabolites pass from blood into urine and feces, and characterize the metabolic profile and routes of excretion of oral \[14C\] HDM002.


Eligibility Criteria:
Inclusion Criteria:

1. Male, healthy adult;
2. Age of 18 to 45 years old (both inclusive);
3. Body mass index (BMI) between 19.0- 32.0 kg/m2 (both inclusive) and body weight no less than 50.0 kg.

Exclusion Criteria:

1. Clinically significant diseases at the time of screening;
2. History or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2), or calcitonin ≥ 35 ng/L during the screening period;
3. History of chronic pancreatitis or acute pancreatitis within 3 months prior to screening;
4. History of acute cholecystitis attack within 3 months prior to screening;
5. Participant judged by investigator has dysphagia, diseases or conditions that affect gastric emptying or affect the absorption of nutrients in the gastrointestinal tract, such as bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, etc.;
6. Any of the following: habitual constipation or diarrhea, hemorrhoids or accompanied by perianal disease, irritable bowel syndrome, inflammatory bowel disease, etc;
7. Use of any prescription medication, over-the-counter medication, Chinese herbal medicine or food supplement within 14 days or 5 half-lives (whichever is longer) prior to the screening period;
8. Patients with any abnormal and clinically significant examinations in given comprehensive physical examination;
9. History of drug abuse (e.g., morphine, ketamine, tetrahydrocannabinolic acid, metham phetamine, methylenedioxyamphetamine, cocaine) or positive urine drug test during the screening period;
10. Positive for hepatitis B surface antigen or E antigen, hepatitis C virus antibody IgG (Anti-HCV IgG), human immunodeficiency virus antigen/antibody combination test (HIV-Ag/Ab) and Treponema pallidum antibody during the screening period.
11. Engaged in working conditions requiring long-term exposure to radioactivity; or significant radioactive exposure ( ≥ 2 CT chest/abdomen tests, or ≥ 3 all other types of X-rays test) within 1 year prior to the trail, or participated in radio-label trails;
A Randomized Clinical Trial of Hydrocortisone Augmentation of Prolonged Exposure

This study seeks to examine the efficacy of hydrocortisone administration in the augmentation of the therapeutic effects of Prolonged Exposure (PE) therapy, an empirically tested treatment shown to be effective in the the treatment of posttraumatic stress disorder (PTSD). The augmentation builds on both the translation of neuroscience findings demonstrating the effects of glucocorticoids (GCs) on learning, and on empirical clinical findings from other investigators demonstrating beneficial effects of GCs in reducing traumatic memories in trauma-exposed persons.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 89
* Capable of understanding, reading, and writing in English
* OIF/OEF veteran with criterion-A trauma while deployed
* Minimum PTSD severity of 60 (CAPS)
* Unmedicated or on a stable psychotropic regimen (i.e., 1 or more months on the same regimen)

Exclusion Criteria:

* Lifetime history of psychotropic disorder, bipolar disorder, or obsessive compulsive disorder
* Moderate or severe traumatic brain injury (TBI)
* A medical or mental health problem other than PTSD that requires immediate clinical attention
* Substance abuse or dependence within the last 3 months
* Suicidal risk (as determined by response of 5 or 6 on the suicidality items of the Montgomery-Asberg Depression Rating Scale (MADRS)) and/or assessed suicide risk on the basis of clinical judgment
* Persons on a psychotropic medication regimen that has not been consistent for one month
* Presence of diabetes mellitus or any current unstable medical illness or condition that represents a contraindication to taking glucocorticoids (this will be determined by history and/or abnormal laboratory findings at medical clearance)
* Unwillingness to discontinue other specialized psychotherapy for PTSD during the 11 weeks of study treatment and the 3 month follow-up (Self-help (non-trauma focused) groups or supportive counseling can be continued but not initiated)
* Pregnant women or those planning to become pregnant within the study period will not be enrolled. Female participants must agree to use an effective method of birth control (i.e., oral contraceptive, Norplant, diaphragm, condom, or spermicide, abstinence) during the course of the study to ensure they do not become pregnant during the course of the study
A Study of LY2510924 and Durvalumab in Participants With Solid Tumors

The main purpose of this study is to evaluate the safety and tolerability of chemokine (C-X-C Motif) receptor 4 (CXCR4) peptide antagonist LY2510924 and durvalumab for phase 1a and 1b in participants with advanced refractory solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Phase 1a: Have histologic or cytologic confirmation of advanced solid tumor
* Have at least 1 measurable lesion assessable using standard techniques by Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
* Have adequate organ function
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
* Have provided tissue from a newly obtained core or excisional biopsy of a tumor lesion or a recent biopsy defined by ≤3 years since last documented progression of disease
* Have an estimated life expectancy of ≥12 weeks, in the judgment of the investigator

Exclusion Criteria:

* Have a serious concomitant systemic disorder including human immunodeficiency virus (HIV), active hepatitis B virus (HBV), active HCV, active autoimmune disorder or disease requiring high dose of steroids

  * Have a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection or chronic diarrhea
  * Have evidence of interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity or active, noninfectious pneumonitis
  * Have an active infection requiring systemic therapy
* Have had prior therapy with an anti-programmed cell death 1 (PD-1), anti-PD-L1, anti-PD-L2, or anticytotoxic T lymphocyte-associated antigen-4 antibody
* Moderate or severe cardiovascular disease
* Have symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment
* Have received a live vaccine within 30 days before the first dose of study treatment
An Efficacy and Safety Study of Ustekinumab in Participants With Active Nonradiographic Axial Spondyloarthritis

The purpose of this study is to assess the efficacy and safety of ustekinumab in adult participants with active nonradiographic axial spondyloarthritis (nr-AxSpA) measured by the reduction in signs and symptoms of nonradiographic axial spondyloarthritis (nr-AxSpA).

This is a phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of ustekinumab in the treatment of participants with active non-radiographic axial spondylo arthritis. Participants will receive either placebo or ustekinumab 45 or 90 milligram (mg). Participants will primarily be assessed for Assessment of Spondylo Arthritis (ASAS) International Society criteria 20 at Week 24. Safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be classified as having nonradiographic axial spondyloarthritis (nr-AxSpA) based on 2009 Assessment of SpondyloArthritis International Society (ASAS) criteria
* Must have an age at nr-AxSpA onset of \<= 45 years
* Must have at screening or active inflammation on magnetic resonance imaging (MRI) as evidenced by the central readers and no radiographic sacroiliitis that fulfills the 1984 modified New York Criteria
* Must have symptoms of active disease at screening and at baseline, as evidenced by both a BASDAI score of \>= 4 and a visual analogue scale (VAS) score for total back pain of more than or equal to (\>=) 4, each on a scale of 0 to 10

Exclusion Criteria:

* Have radiographic sacroiliitis fulfilling the 1984 modified New York Criteria
* Have other inflammatory diseases that might confound the evaluations of benefit from the ustekinumab therapy
* Have received any systemic immunosuppressives or disease-modifying anti-rheumatic drug (DMARDs) other than methotrexate (MTX), sulfasalazine (SSZ), or hydroxychloroquine (HCQ) within 4 weeks prior to first administration of study agent
* Have received epidural, intra-articular, intramuscular (IM), or intravenous (IV) corticosteroids, including adrenocorticotropic hormone during the 4 weeks prior to first administration of study agent
* Have received prior biologic therapy other than anti-TNFα
* Have received more than 1 prior anti-TNFα agent
Audit of the Response Time of the Anaesthetic and Surgical Techniques for Crash Caesarean Section

A decision-to-delivery interval of 30 minutes for category-1 Caesarean section deliveries is the standard of practice recommended by clinical guidelines.

Our institution established a protocol for category-1 ('crash') CS to expedite deliveries. This retrospective audit evaluated all women who underwent category-1 CS in KK Women's and Children's Hospital from 2010 to 2013.

Eligibility Criteria:
Inclusion Criteria:

* Category One Caesarean Section at KK Women's and Children's Hospital, Singapore between 2010 to 2013.

Exclusion Criteria:

* No specific exclusion criteria, retrospective audit
Evaluating Patient Satisfaction After Cataract Surgery With Multifocal Intraocular Lens

Multifocal lens allow most patients to be spectacle-free after cataract surgery. Most studies published up-to-date have focused on visual acuity, but not on patient-reported outcomes. Since some patients with very good postoperative visual acuity report being very uncomfortable after surgery, the aim of this study is to evaluate if patient satisfaction is correlated with other outcomes, such as low-contrast visual acuity, contrast sensitivity, photic phenomena and ability to tolerate defocus. Patients who have undergone surgery with bilateral multifocal intraocular lens implantation will be carefully evaluated 3 months after surgery to try to determine the factors that correlate with patient reported outcomes as evaluated with the Catquest SF-9 questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Previous bilateral cataract surgery
* Bilateral implantation of multifocal intraocular lens

Exclusion Criteria:

* Presence of ocular pathologies
* Intra- or postoperative complications
Neoadjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer

This is a prospective, open label study to evaluate the efficacy and safety of neoadjuvant pyrotinib in early breast cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Female, Aged ≥18 and ≤70 years
* Histologically confirmed invasive HER2 positive breast cancer, early disease(Stage ⅡA-Ⅲ)
* Subjects with at least one evaluable lesion
* ECOG 0-1
* Adequate organ function

Exclusion Criteria:

* Metastatic disease (Stage IV)
* Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption
* Treated or treating with T-DM1, lapatinib and neratinib before study entry
* History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation
* Subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any heart diseases judged by investigator as unsuitable to participate in the trial
* Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test. Female patients of childbearing age that are reluctant to take effective contraceptive measures throughout the trial period
* Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study
Iodine Nutrition Status and Clinical Characteristics of Thyroid Cancer

The effect of iodine nutritional status on thyroid cancer has been controversial for many years. We designed a prospective cohort study that recruiting patients in different iodine areas who underwent thyroid cancer surgery in branch hospitals from 2012 to 2019，and follow up their clinical outcomes. We aimed to analyse the relationship between regional iodine nutrition level and pathological types, clinical features, and prognosis of thyroid cancer.

Three sub centers were selected in high iodine (Jining/Liaocheng/Heze) and moderate iodine (Jinan/Shenyang/Haerbin) areas respectively. Patients lived in the above-mentioned regions for at least 5 years and diagnosed as thyroid cancer and underwent thyroid surgery in branch hospitals from 2012 to 2019 were recruited.

Eligibility Criteria:
Inclusion Criteria:

1. Age range: 18\~65 years old, gender not limited;
2. Living in the selected region for at least 5 years;
3. Patients who underwent thyroid surgery at various research centers were pathologically diagnosed with thyroid cancer;
4. The clinical data （general information、surgical scope 、pathological report、utrasonic report, etc ）of the case is complete.

Exclusion Criteria:

1. Diagnosed as other types of cancer or thyroid metastatic cancer;
2. There are serious comorbidities such as heart, liver, and kidney diseases present;
3. Unable to follow up on prognostic information.
Effect of a Decision Aid on Decision Making for the Treatment of Pelvic Organ Prolapse

Pelvic organ prolapse is a common condition that affects millions of women every year. There are many options for treatment and it can be difficult to make a decision as how best to proceed. Previous studies have shown that decisional aids (DAs) may improve knowledge, physician-patient communication, decisional conflict, and patient satisfaction. However, no study has evaluated the role of a decisional aid among women presenting for evaluation and management of prolapse. We would like to determine if a decision aid for prolapse decreases the amount of decisional conflict women face when choosing a plan of care.

We hypothesize that there will be a difference in the level/amount of decisional conflict between women who receive a DA and those who do not. Specifically, we anticipate that women randomized to receiving standard counseling and a DA with have less decisional conflict than the cohort receiving standard counseling alone.

Women scheduled for the evaluation and management of pelvic organ prolapse at Hartford Hospital will be contacted via telephone prior to the initial consultation visit to ascertain interest for this study. If they are interested, they will be randomized to one of two groups: those that receive a DA and those that do not.

This study requires you to answer some questions about the information packet you received in the mail. We routinely send a packet to all of our new patients. Half of the participants received a decision aid to supplement their information packet and the other half received our routine informational packet. You will be asked to complete a set of 2 questionnaires. It will take less than 10 minutes to complete these questions.

All data will be extracted and used by only the investigators on this study. The data will be stored on a restricted-access network drive and results will be reported in aggregate and no personal health history will be disclosed. Our primary outcome for this analysis is decisional conflict differences in those who receive a DA and those who do not.

Eligibility Criteria:
Inclusion Criteria:

* Female
* ≥18 years old
* Scheduled for consultation visit for pelvic organ prolapse of any type (cystocele, rectocele, enterocele, uterine prolapse, and/or uterovaginal prolapse)

Exclusion Criteria:

* \<18 years old
* Non-English speaking
* Any patient who declines, or expresses unwillingness to being contacted for participation in the study
* Planned concomitant non-gynecologic procedure
* Established patient in the practice