cyrilzakka/clinical-trials huggingface dataset:
A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus

The purpose of this study is to evaluate the efficacy and safety of MEDI-546 compared to placebo in subjects with chronic, moderately-to-severely active systemic lupus erythematosus (SLE) with an inadequate response to standard of care treatment for SLE.

This is a Phase 2, multinational, multicenter, randomized, double-blind, placebo controlled, parallel-group study to evaluate the efficacy and safety of 2 intravenous (IV) treatment regimens in adult participants with chronic, moderately-to-severely active SLE with an inadequate response to SOC SLE. The investigational product (anifrolumab or placebo) will be administered as a fixed dose every 4 weeks (28 days) for a total of 13 doses.

Eligibility Criteria:
Inclusion Criteria:

* Fulfills at least 4 of the 11 American College of Rheumatology (ACR) criteria for systemic lupus erythematosus (SLE) including a positive antinuclear antibody (ANA) greater than or equal to 1:80 or elevated anti-double-stranded DNA or anti-Smith antibody at screening
* Pediatric or adult SLE with chronic disease activity for greater than or equal to 24 weeks
* Weight greater than or equal to 40 kg
* Currently receiving stable dose of oral prednisone (or equivalent) less than or equal to 40 mg/day and/or antimalarials/immunosuppressives
* Active moderate to severe SLE disease based on SLE disease activity score (SLEDAI) and British Isles Lupus Assessment Group Index (BILAG) and Physicians Global Assessment
* No evidence of cervical malignancy on Pap smear within 2 years of randomization
* Female participants must be willing to avoid pregnancy
* Negative tuberculosis (TB) test or newly positive TB test due to latent TB for which treatment must be initiated at or before randomization.

Exclusion Criteria:

* Active severe SLE-driven renal disease or unstable renal disease prior to screening
* Active severe or unstable neuropsychiatric SLE
* Clinically significant active infection including ongoing and chronic infections
* History of human immunodeficiency virus (HIV)
* Confirmed Positive tests for hepatitis B or positive test for hepatitis C
* History of severe herpes infection such as herpes encephalitis, ophthalmic herpes, disseminated herpes
* Live or attenuated vaccine within 4 weeks prior to screening
* Participants with significant hematologic abnormalities.
An Extension Study of ABT-199 in Subjects With Advanced Non-Hodgkin's Lymphoma

This is a Phase 1, open-label, multicenter, extension study. Subjects with non-Hodgkin's lymphoma (NHL) (excluding chronic lymphocytic lymphoma \[CLL\], small lymphocytic lymphoma \[SLL\], and mantle cell lymphoma \[MCL\]) who completed a prior ABT-199 study, or were active and assigned to ABT-199 when the study was completed, may roll over into this extension study. Subjects will receive ABT-199 during this study.


Eligibility Criteria:
Inclusion Criteria:

* Subject has completed a prior ABT-199 study (and had met the criteria for a diagnosis of NHL and all other eligibility criteria for the previous study) and the investigator believes that treatment with ABT-199 is in the best interest of the subject.

Exclusion Criteria:

* Subject discontinued ABT-199 administration before completing the prior study (due to disease progression, toxicity, withdrawn consent, other).
* Subject has any medical condition that in the opinion of the investigator places the subject at an unacceptably high risk for toxicities.
* Subject has not recovered to ≤ Grade 2 clinically significant adverse effect(s)/toxicity(ies) of previous therapy.
* Subject has been diagnosed with Post-Transplant Lymphoproliferative Disease (PTLD), Burkitt's lymphoma, Burkitt-like lymphoma, lymphoblastic lymphoma/leukemia, chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or mantle cell lymphoma (MCL).
A Study to Evaluate the Effectiveness and Safety of IONIS-FB-LRx, an Antisense Inhibitor of Complement Factor B, in Adult Participants With Primary IgA Nephropathy

The purpose of this study is to evaluate the effectiveness and safety of IONIS-FB-LRx, an antisense inhibitor of complement factor B messenger ribonucleic acid (CFB mRNA), and to evaluate the effect of IONIS-FB-LRx on plasma factor B (FB) levels and serum AH50, CH50 activity in participants with primary immunoglobulin A (IgA) nephropathy.

This is a Phase 2, single arm open-label clinical study in up to 25 participants that will consist of a screening period, a 24-week treatment period, an optional treatment extension period of up to an additional 48 weeks, and a 12- week post-treatment follow-up evaluation period.

Eligibility Criteria:
Inclusion Criteria

* Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal OR use a highly effective method of birth control
* Biopsy-proven primary immunoglobulin A (IgA) nephropathy
* Hematuria
* Proteinuria

Exclusion Criteria

* Clinically significant abnormalities in medical history (e.g., dementia, stroke, acute coronary syndrome, thrombocytopenia, or major surgery within 3 months of Screening)
* Diagnosis of primary or secondary immunodeficiencies of B-lymphocyte function, splenectomy, or history of recurrent meningococcal disease
* Active infection 30 days prior to study
* Estimated glomerular filtration rate (eGFR) ≤ 40 milliliters per minute per 1.73 square meters (mL/min/1.73m\^2) using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
* Presence of another renal disease including, but not limited to, diabetes and/or diabetic nephropathy, thin basement membrane disease, Alport's disease, IgA Nephritis (Henoch-Schonlein purpura), lupus nephritis, Minimal Change Disease, post-infectious glomerulonephritis or any other cause of proteinuria or secondary IgA nephropathy (including, but not limited to Celiac disease, Crohn's disease, human immunodeficiency virus (HIV), liver cirrhosis)
* History of renal transplant or another organ transplant
* Treatment with another investigational drug, biological agent, or device within 6 months of screening, or 5 half-lives of investigational agent, whichever is longer
* Administration of immunosuppressive/immunomodulatory medication 12 months prior to study drug administration, except for short-term treatments.
* Other protocol-specified inclusion/exclusion criteria may apply
Ridge Preservation With Moldable Beta-tricalcium Phosphate Bone Substitute on Non-containable Non-Molar Extraction Sites

Purpose of the single arm study is to clinically and histologically evaluate alloplastic in-situ hardening, moldable beta-tricalcium phosphate(TCP) bone graft material and polylactide membrane in alveolar ridge preservation following extraction of non-molar teeth with non-containable extraction sockets.


Eligibility Criteria:
Inclusion Criteria:

* adequate restorative space for a dental implant restoration, if the subject decides previous to study participation that they would like an implant. Note, agreement to implant placement is not a requirement of the study
* minimum of 10-mm vertical bone without impinging on adjacent vital structures (Maxillary sinus, neurovascular bundles)
* single-rooted tooth to be extracted
* American Society of Anesthesiologists (ASA) Physical Status Classification I or II
* age \>18 years old
* subjects who had \>50% of height on any portion on the buccal wall of dehiscence and/or fenestration of the extraction socket following extraction will be included from this study
* adjacent teeth to extraction site will be present during healing period
* willingly sign informed consent and authorization.

Exclusion Criteria:

* do not meet any inclusion criteria
* pregnancy or nursing woman
* subjects with active systemic or localized infection (exclude chronic periodontitis)
* subjects with a history of any medical conditions that contraindicated or weighed against dental implant placement such as history of bisphosphonate drug use, chemotherapeutic or immunosuppressive agents, autoimmune disease, or poorly controlled diabetes (HBA1c\>7%)
* subjects with smoking habit (more than 10 cigarettes per day)
A Real World Experience of Dapagliflozin in Type 2 Diabetes

Type 2 diabetes mellitus (T2DM) is creating a health pandemic globally. Management of type 2 diabetes involves combination of lifestyle intervention and drug intervention, which includes sodium-glucose transporter 2 (SGLT-2) inhibitors, such as dapagliflozin. Dapagliflozin (Forxiga®) was approved by the Malaysian Drug Authority for the treatment of type 2 diabetes in 2014. This study will describe the characteristics of patients who are prescribed dapagliflozin by diabetologists/endocrinologists in a tertiary referral center and describe their glycaemic control, weight, and renal function at baseline and during use of dapagliflozin.

The prevalence of type 2 diabetes among adults \>18 years old is 17.5% in Malaysia, where half of them are undiagnosed. Diabetes also accounts for 14.5% of all-cause mortality worldwide, with close to half of the deaths are in subjects \<60 years old. These highlight the importance of early diagnosis of disease, timely intervention with appropriate therapy, and treating type 2 diabetes patients to goal to prevent the development of complications.

Asian type 2 diabetes phenotypes are different than Caucasians, i.e. significant pancreatic beta-cell dysfunction, higher visceral adiposity, more vulnerable to cardio-renal complications. Although clinical trials of SGLT-2 inhibitors have been published, real-world data on the use of this new class of antidiabetic medication is still lacking, in particularly among Asians.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of T2DM prior to the first prescription of dapagliflozin
* Patients with T2DM who are initiated with dapagliflozin from March 2014 till December 2015
* Patients need to be on dapagliflozin therapy for at least six consecutive months from the index date
* Patients need to have diabetologists/endocrinologists' follow up for at least six months after the initiation of dapagliflozin

Exclusion Criteria:

* Patients with T2DM who are initiated with dapagliflozin after December 2015
* Patients with incomplete electronic medical records
* Patients with Type 1 diabetes
* Patients with latent autoimmune diabetes of adults (LADA)
* Female Patients with T2DM who are found to be pregnant during the treatment period of dapagliflozin
Assessment of Normal Values of Esophagogastric Junction (EGJ) Distensibility in Healthy Volunteers

To assess normal values of EGJ distensibility in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. No history of gastrointestinal disease, especially gastro-esophageal reflux disease
2. BMI = 18-30 kg/m²
3. Caucasian race
4. Subject signed the informed consent form and is able to adhere to study protocol

Exclusion Criteria:

1. Age \< 18 years
2. Previous esophageal or gastric surgery
3. Co-morbidities (including cardiopulmonary disease, collagen diseases, obesity, coagulation disorders and co-morbidity hindering upper gastrointestinal endoscopy)
4. Patients using anticoagulants
5. Patients unable to give informed consent
6. Smoking
7. History of alcohol abuse or current excessive alcohol consumption (\> 2 alcoholic beverages per day or \> 14 alcoholic beverages per week)
The Q-REDUCE Study

The purpose of this study is to design a fast-track pathway for patients referred to the University Hospital of Southern Denmark, Esbjerg, with high probability of having a dislocated hip prosthesis with the primary aim to reduce the time from arrival to reduction and the total hospitalization time. Secondary aims are to

* investigate whether quicker prosthesis reduction influences on hip function and quality of life afterwards
* reduce the pain experience immediately and in the long term
* increase patient satisfaction

without changing the overall complication rate and readmission/mortality


Eligibility Criteria:
Inclusion Criteria:

* a history of either a THA or a HA in combination with at least one of the following terms
* having sustained a sudden, incorrect movement or twist in the hip joint in either a bending, sitting or supine position leading to inability to stand or walk
* misalignment of the concerned lower extremity (typically shortened, with inward/outward rotation)

Exclusion Criteria:

* recurrent dislocations during the same hospital admission (already "in the house")
* anticipated difficult airway by the attending anesthesiologist
* anticipated need for extended respiratory or hemodynamic monitoring by the attending anesthesiologist
* American Society of Anesthesiologists (ASA) score \> 3
* Body Mass Index (BMI) \> 40
* active drug abuse
* contraindication for Propofol or Esketamine
Special Drug Use Investigation for ARIXTRA® (Fondaparinux) Injection

This post-marketing surveillance study was designed to collect and assess the information on proper use of fondaparinux injection, such as the safety and efficacy under actual use conditions, in subjects undergoing orthopedic surgery of the lower limb at high risk of developing venous thromboembolism.

(ARIXTRA® is a trademark of the GlaxoSmithKline group of companies.)


Eligibility Criteria:
Inclusion Criteria:

* Subjects undergo orthopedic surgery of the lower limb at high risk of developing venous thromboembolism

Exclusion Criteria:

* Not applicable
Ambispective Study to Assess the Effect of Pretreatment With a Levonorgestrel-Releasing Intrauterine System Versus Oral Progestin

The study participants' relevant medical records will be collected and reviewed for the retrospective subjects and after obtaining informed consent for the prospective subjects. The study materials that will be used will include blood tests, transvaginal ultrasound and magnetic resonance imaging (MRI). The study will involve two study arms

The study participants' relevant medical records will be collected and reviewed for the retrospective subjects and after obtaining informed consent for the prospective subjects. The study materials that will be used will include blood tests, transvaginal ultrasound and magnetic resonance imaging (MRI). The study will involve two study arms:

Arm 1: Women with adenomyosis pretreated with levonorgestrel-releasing intrauterine device (LNG-IUS) and proceeding with the ICSI Arm 2: Women with adenomyosis pretreated with oral progestin "Dienogest" and proceeding with the ICSI Primary and secondary key measurements will be used in the study.

The primary measures will include:

* Presence of intrauterine gestational sac at 12 weeks
* Presence of fetal heart pulsation at 12 weeks

The secondary key measures will include:

* Occurance of abortion in the 1st trimester
* Appearance of ectopic pregnancy diagnosis by:

Ultrasound Serum β-HCG level Symptoms of pain and bleeding

* Two serum β-HCG levels in 48hrs interval to emphasis biochemical pregnancy
* Recording the the baseline characteristics of the study participants

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed using both the transvaginal ultrasound study (TVS) and MRI criteria

   * Main criteria for sonographic and MRI diagnosis of adenomyosis are:

   The appearance of asymmetrical thickening of the myometrium Irregular cystic areas within the myometrium Linear striations radiating out from the myometrium
2. Patients ≤42 years old at the time of starting ICSI cycle
3. Cryopreserved embryo transfer cycles
4. The presence of at least one good cryopreserved day 3 embryo.

Exclusion Criteria:

1. Transfer of a poor-quality embryo (grades 3 or 4)
2. History of myomectomy
3. Pelvic ultrasound that showed the presence of uterine fibroids, a hydrosalpinx or endometrial polyps (all known causes of implantation failure).
Interventions to Prevent Adolescents With Type 1 Diabetes From Long-term Complications

The purpose of this study is to evaluate the effectiveness of diabetes management training combined with the method of Motivational Interviewing with elements of Cognitive Behaviour Therapy and E-mail support in the treatment of type 1 diabetes in adolescents (age range 13-20 years) compared to a control group. The investigators assess motivational changes and effects on metabolic control.

Diabetes mellitus type1 requires lifelong insulin substitution, aiming at near normal glycaemia. Insufficient metabolic control (HbA1c \> 8 %) leads to micro and macro- vascular complications. Especially in adolescence a lack of compliance leads to deteriorated metabolic control. Motivational factors play a pivotal role in this age-group, however they have neither been studied so far nor considered in interventions with diabetes patients.

Therefore, the aim of this study is to evaluate in a multi-centred randomized controlled trial the effectiveness of diabetes management training with the method of Motivational Interviewing with elements of Cognitive Behaviour Therapy and E-mail support.

Sixty adolescents within the age group of 13-20 years and HbA1c levels \> 8 % will - after a refresher course in diabetes education - be involved to 2-weekly individual interventions sessions including motivational interviewing and CBT-modules with a psychologist and weekly e-mail support for a period of six month in order to improve HbA1c levels, self- efficacy in diabetes management and general quality of life.

As control group sixty adolescents within the age group of 13-20 years and HbA1c levels \> 8 will - after a refresher course in diabetes education - get treatment as usual, including routine medical support visits, unspecific psychological consultations and unspecific e-mail support to match with the intervention group for time bonus.

We assess motivational changes and effects on metabolic control (HbA1c) and define the predictors of positive effects on glycaemic control.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus, type1
* HbA1c\>8
* 1 year of diagnosis
* Access to Internet available

Exclusion Criteria:

* N/A
Comparison of Anesthetic Modalities on Hemodynamic Stability and Postoperative Pain in Diabetic Foot Patients Undergoing Minor Lower Extremity Amputation

Diabetic foot ulcer is the most common cause of non traumatic lower extremity amputations (LEA) associated with diabetes. Traditionally general and spinal anesthesia were the preferred modality of anesthesia. The use of sciatic nerve block has recently gained popularity, however, without the supporting evidence of any benefits. This study was to evaluate the comparison of anesthesia modalities for hemodynamic stability and postoperative pain in diabetic foot patients undergoing minor LEA.


Eligibility Criteria:
Inclusion Criteria:

* diabetic foot patients who underwent minor LEA

Exclusion Criteria:

* emergency cases
* patients who underwent major upper or lower extremity amputations
* patients who received general anesthesia following fail regional or spinal anesthesia
* patients who underwent LEA within 1year, and patients who underwent other concomitant surgeries
The Effects of Therapy With Teriparatide on Vascular Compliance and Osteoprotegerin/RANKL

The purpose of this study is to determine what effect teriparatide will have on vascular (blood vessel) compliance and osteoprotegerin (bone fluid)and RANKL levels (bone cells).

Research subjects participation is about 6 months. Subjects will give themselves daily injections of teriparatide after instruction on technique.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women and men over the age of 40 who are starting therapy with teriparatide

Exclusion Criteria:

* Patients with diabetes mellitus
* current smokers
* patients with a history of organ transplantation
* Patients currently of previously on glucocorticoid therapy within the past year
* Patients with serum creatinine above 1.5 mg/dl, patients with uncontrolled hypertension (BP 140/90 or greater)
* Patients ineligible for teriparatide therapy: History of metabolic bone disease other than osteoporosis
* History of radiation therapy
* Patients pregnant or nursing
* History of bone metastasis or skeletal malignancies
* History of hypercalcemia
Effect of Banning Menthol Flavorant on Cigarette and E-Cigarette Use

In this pilot study, menthol cigarette smokers will be randomized to one of three experimental marketplaces: 1) a condition simulating a ban on menthol cigarettes but not menthol e-cigarettes (condition A); 2) a condition simulating a ban on both menthol cigarettes and menthol e-cigarettes (Condition B); and 3) a condition in which menthol is not banned for either product (Condition C - the control condition). All conditions would have medicinal nicotine available if subjects decide to quit tobacco products entirely. At visits occurring every two weeks over a 6 week period, subjects will receive "credits" that they could exchange for any product available in their randomized marketplace condition. Outcomes include the amount of each tobacco product used.


Eligibility Criteria:
Inclusion Criteria:

* Be between the ages of 18 and 64
* Purchase exclusively menthol cigarettes
* Not currently motivated to quit smoking
* Smoking a minimum number of cigarettes per day

Exclusion Criteria:

* Report a serious, unstable medical or psychiatric condition
* Use any medications that might interfere with measures to be studied (for example, medications known to affect smoking)
* Have used any smoking cessation therapy during the past month
* Regularly use any form of tobacco other than cigarettes
* Are pregnant or breast feeding or planning to become pregnant or breast feed during the study