cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients With Bullous Pemphigoid

The main purpose of this study is to investigate whether dupilumab is effective and safe for the treatment of bullous pemphigoid. Dupilumab is a type of drug called a "monoclonal antibody". An antibody is a special kind of protein that the immune (defense) system normally makes to fight bacteria and viruses. Bullous pemphigoid is an autoimmune subepidermal blistering disease, predominately affecting the elderly (typical onset after age 60).

The study is looking at several other research questions, including:

* Side effects that may be experienced by people taking dupilumab
* How dupilumab works in the body and affects the body
* How dupilumab affects quality of life
* How much dupilumab is present in the blood
* To see if dupilumab works to wean the patient off oral corticosteroids


Eligibility Criteria:
Key Inclusion Criteria:

* Patients must have characteristic clinical features of bullous pemphigoid (BP) (eg, urticarial or eczematous or erythematous plaques, bullae, pruritus) at the screening and baseline visits.
* Study participants are required to have a confirmed diagnosis of BP based on histopathology, immunopathology, and serology at the baseline visit, as defined in the protocol.
* Bullous Pemphigoid Disease Area Index (BPDAI) activity score ≥24 at baseline and screening visits.
* Baseline peak pruritus NRS score for maximum itch intensity ≥4
* Karnofsky performance status score ≥50% at the screening visit.

Key Exclusion Criteria:

* Forms of pemphigoid other than classic BP (eg, Brunsting-Perry cicatricial pemphigoid, anti-p200 pemphigoid, epidermolysis bullosa acquisita, or BP with concomitant pemphigus vulgaris)
* Patients who are receiving treatments known to cause or exacerbate BP (eg, angiotensin converting enzyme inhibitors, penicillamine, furosemide, phenacetin, dipeptidyl peptidase 4 inhibitor) who have not been on a stable dose of these medications for at least 4 weeks prior to the screening visit
* Have ever received treatment with an IL-4 or IL-13 antagonist such as dupilumab, tralokinumab, or lebrikizumab.
* Treatment with systemic corticosteroids within 7 days before the baseline visit
* Treatment with topical corticosteroids of medium potency or higher, topical calcineurin inhibitor, or topical crisaborole within 7 days before the baseline visit
* Treatment with non-steroidal immunosuppressive/immunomodulating drug(s) (eg, mycophenolate mofetil, azathioprine, or methotrexate) within 4 weeks before the baseline visit.
* Treatment with BP-directed biologics as follows:
* Any cell-depleting agents including but not limited to rituximab: within 12 months before the baseline visit, or until lymphocyte and CD 19+ lymphocyte count returns to normal, whichever is longer
* Other biologics (such as IL-5 inhibitors benralizumab or mepolizumab): within 5 half-lives (if known) or 16 weeks prior to the baseline visit, whichever is longer
* Intravenous immunoglobulin within 16 weeks prior to the baseline visit

NOTE: Other Protocol Defined Inclusion/Exclusion Criteria Apply
Paricalcitol Effect on Anemia in CKD

Current activated Vitamin D therapies are approved for treating secondary hyperparathyroidism in chronic kidney disease (CKD), and a large body of experimental data in animals confirms the effects of Vitamin D that extend beyond mineral metabolism. Several studies show that the benefits are greater with the newer vitamin D analog paricalcitol when compared with calcitriol. A large gap exists in our knowledge between epidemiological studies in human that demonstrate improved outcomes with vitamin D use and observations in preclinical studies demonstrating the pleiotropic effects of Vitamin D. To explore the provenance of epidemiological outcomes in CKD, we conducted a pilot randomized trial to determine whether the use of paricalcitol, compared to calcitriol, leads to improvement in anemia, a marker associated with worse outcomes in chronic kidney disease, and whether this effect not only reflects the hyperparathyroidism correction, but is also dependent on the direct effects of paricalcitol on erythroid progenitor cells.

To better understand the direct effects of paricalcitol on anemia in patients with chronic kidney disease (stage 3-5), we conducted a pilot trial in 60 patients who were randomly allocated equally to 2 groups to receive or not paricalcitol orally for 6 months.

Eligibility Criteria:
Inclusion criteria:

* age \> 18
* written informed consent
* CKD stage 3-5 (eGFR \<60 ml/min/1,73 m2)
* PTH 30-300 pg/ml
* Hb \<10 g/dl \>3 consecutive months
* Ferritin \> 100 ng/ml
* transferrin saturation (TSAT) 20-40%
* mean corpuscular volume (MCV) 85-95%
* for patients treated with Ace-inhibitors or angiotensin receptor blockers, dose stable \>3 months
* for patients treated with erythropoiesis-stimulating agents (ESA), dose stable \>3 months

Exclusion criteria:

* anemia due to non renal cause
* presence of malignancies, inflammatory or infectious disease \>3 months
* pregnancy
* bleeding \>6 months
* C-reactive protein (CRP) \>1 mg/dl
* poorly controlled hypertension (PAS \> 170 mmHG and PAD \>100 mmHg)
* severe malnutrition
* hypercalcemia (\>10,5 mg/dl)
* hyperphosphatemia (\>5,5 mg/dl)
* surgical interventions \>3 months
* acute myocardial infarction, unstable angina, stroke or transitory ischemic attack, deep venous or pulmonary thromboembolism, congestive heart failure \>3 months
To Determine the Activity and Mechanisms of Cranberries to Attenuate Skin Photoaging and Improve Skin Health in Women

Previous studies have shown that cranberry phytochemicals scavenge reactive carbonyls. Cranberry polyphenols have been reported to attenuate collagen degradation and inhibit oxidative stress in human cells. We hypothesize that cranberry juice consumption will attenuate skin photoaging and improve skin health in women via alleviate oxidative stress.

One of the causative factors of skin ageing is cumulative oxidative damages due to aerobic metabolism and UV irradiation. Cumulation of reactive oxygen species (ROS) causes collagen glycation and crosslinking which are direct causes of skin ageing. Previous studies have shown that cranberry phytochemicals scavenge reactive carbonyls. Cranberry polyphenols have been reported to attenuate collagen degradation and inhibit oxidative stress in human cells. It is unknown whether cranberry juice consumption could protect against UV -induced erythema and improve overall skin health. Furthermore, if it does have effect, what will be the mechanism? This human intervention study will be conducted to answer these questions. We hypothesize that cranberry juice consumption will attenuate skin photoaging and improve skin health in women via alleviate oxidative stress.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* BMI (18.5-29.9)
* Body weight ≥110 pounds

Exclusion Criteria:

* Skin Cancer
* Smokers and frequent alcohol use
* Pregnancy
* Breast-feeding
* intake of medication that might influence the outcome of the study
* sunbathing or the use of tanning bed
* intake of vitamin/mineral supplements
The Effect of Motivational Interviewing on Self-Efficacy and Quality of Life in Gestational Diabetes Mellitus

This study is a randomized controlled experimental study planned to investigate the effect of motivational interviewing on health management self-efficacy and quality of life in pregnant women with gestational diabetes mellitus.

This study is a randomized controlled experimental study planned to investigate the effect of motivational interviewing on health management self-efficacy and quality of life in pregnant women with gestational diabetes mellitus. 24-26 weeks for pregnant women diagnosed with gestational diabetes mellitus. A total of motivational interviews will be held for 4 weeks with the pregnant women. Personal Information Form, Health Management Self-Efficacy Scale and Quality of Life Scale will be administered before the motivational interview, and the Health Management Self-Efficacy Scale and Quality of Life Scale will be administered at the end of the motivational interview.

Eligibility Criteria:
Inclusion Criteria:

Being pregnant for the first time

* Being diagnosed with gestational diabetes mellitus
* 24-28. Being in the pregnancy week
* Being able to speak and understand Turkish
* Being 18 years or older
* Having a single and viable fetus
* Volunteering to participate in research
* Having and being able to use a mobile phone
* Having all check-ups at the same hospital and regularly throughout pregnancy,

Exclusion Criteria:

* Being diagnosed with diabetes mellitus (type 1, type 2 diabetes) before pregnancy
* Having a psychiatric diagnosis,
* Having a chronic disease
* Having risk factors such as threat of premature birth, placenta previa, premature rupture of membranes
* Having any disability that would prevent communication (deafness, hearing impairment, etc., use of languages other than Turkish),
* Pregnant women who do not want to continue the study and give birth before the 37th week of pregnancy will be excluded from the study.
Enhancing Support for Women With Type 2 Diabetes: Follow-Up

This study is a 5-year continuation of "The Mediterranean Lifestyle Program." The purpose of this follow-up study is to determine the long-term effects from prior participation in an intervention promoting healthful eating, exercise, quitting smoking, stress management, and social support. Participants are post-menopausal women with type 2 diabetes.

Coronary heart disease (CHD) is the leading cause of death and functional limitations among women in the U.S. Postmenopausal women with diabetes are at especially high risk of CHD, but CHD research with this population is very limited. This project addresses the poorly understood "natural history" of long-term maintenance of change in multiple behaviors (i.e., dietary, physical activity, social support, smoking cessation, and stress management) related to CHD risk, as well as the effects of theoretically important mediating variables on relapse and maintenance. The study is a continuation of a research project that has already demonstrated significant and consistent positive effects of a lifestyle change intervention on reduction of behavioral CHD risk factors. This research relies on a framework that synthesizes social-cognitive, social-ecologic, and goal-systems theories.

Eligibility Criteria:
Inclusion Criteria: All participants in the original study are eligible. The inclusion criteria for the original study were:

* diagnosis of type 2 diabetes for at least 6 months
* being post-menopausal
* living independently (e.g., not in an institution or nursing home)
* having a telephone
* ability to read English
* not being developmentally disabled, and
* living within 30 miles of the Eugene-Springfield metropolitan area.

Exclusion Criteria: Exclusion criteria for the original study included:

* being older than 75 years of age
* having life-threatening illnesses, or
* planning to move from the local area within the time span of the study.
Cognition in Motion

The purpose of this study is to evaluate the effect of low-intensity exercise on cognitive functioning during activity. Evaluation was accomplished by having participants perform standardized cognitive tests while in three forms of low-intensity exercise and then comparing results to performance when sitting.

While studies have demonstrated the beneficial effects of exercise, even when low-intensity, on physical health, investigations into cognitive performance during these periods of activity are increasing in number. For changes in the workplace to occur, data needs to show that mental processing is not compromised while engaging in low-intensity exercise.

In this current study, participants, after giving written consent, performed quantitative, computer-based cognitive tests to evaluate for differences in performance between active and sedentary conditions. The participants engaged in four activity modalities: sitting, standing, biking slowly on a stationary bicycle, and walking at 1mph. The validated tests used were immediate and delayed verbal recall, the color-word test based on the Stroop test, and the "n-back" test. Responses were scored according to both the speed in answering along with accuracy on each test. From the scores generated, effect sizes were calculated for sitting and compared to effect sizes for cumulative activity stations for statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Student at Baylor College of Medicine
* Able to perform low-intensity exercise

Exclusion Criteria:

* Not a student at Baylor College of Medicine
Study of VI-0521 Compared to Placebo in Treatment of Obesity in Adults

The purpose of this study is to evaluate the efficacy and safety of two doses of VI-0521 compared to placebo in treatment of obesity in an adult population with BMI ≥ 35.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) ≥ 35 kg/m2
* Informed consent
* 70 years of age or less
* Triglyceride level ≤ 200 mg/dL with treatment of 0 or 1 medications
* Blood pressure of ≤ 140/90 mmHg with treatment of 0-2 medications for hypertension
* Fasting blood glucose level of ≤ 110 mg/dL

Exclusion Criteria:

* Stroke/myocardial infarction (MI)/unstable cardiovascular disease within 6 months
* Clinically significant renal, hepatic or psychiatric disease
* Unstable thyroid disease or replacement therapy
* Nephrolithiasis
* Obesity of known genetic or endocrine origin
* Participation in a formal weight loss program or lifestyle intervention
* History of glaucoma or intraocular pressure
* Pregnancy or breastfeeding
* Alcohol abuse
* Smoking cessation within previous 3 months or plans to quit smoking during study
* Eating disorders
* Cholelithiasis within past 6 months
* Excluded medications
* Type 2 diabetes
* Previous bariatric surgery
* History of bipolar disorder or psychosis
Study to Investigate the Absorption, Metabolism and Excretion of [14C] Anlotinib in Patients With Advanced Cancer Patients

The purpose of this study is to Investigate the Absorption, Metabolism and Excretion of \[14C\] Anlotinib in Patients With Advanced Cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* signed and dated informed consent
* histologically or cytologically confirmed diagnosis of advanced solid tumor (including RCC、NSCLC、STS and CRC)
* failed to the treatment of line 1 or 2
* ECOG PS:0-1,Life expectancy of more than 3 months
* main organs function is normal

Exclusion Criteria:

* prior treatment with Anlotinib or Allergic to drug or its formulation ingredients
* subjects with the gastrointestinal tract, liver and kidney disease of affect drug absorption and metabolism
* CTCAE(4.0) Grade 1 or higher non-remission toxicity induced by any other previous treatments
* patients with pleural effusion or ascites, causing respiratory syndrome (CTCAE Grade 2 or higher dyspnea \[Grade 2 dyspnea refers to Shortness of breath with a small amount of activities, affecting Instrumental activities of daily life\])
* patients underwent major surgical treatment，open biopsy or significant traumatic injury within 28 days prior to assignment
Comparison the Postoperative Quality of Recovery Between Neostigmine and Sugammadex in Elderly Patients Undergoing Trans Pars Plana Vitrectomy With General Anesthesia -Randomized Controlled Trial-

Sugammadex has been approved as the first targeted reversal binding agent providing predictable and complete reversal of neuromuscular blockade induced by rocuronium or vecuronium, and achieving so with a favourable safety profile.

Its benefits over traditional acetylcholinesterase inhibitors have been widely demonstrated in many studies. The scope of such studies has been mostly related to the efficacy of NMB reversal and safety. However, the clinical use of sugammadex led some anaesthesiologists to observe that following the use of this agent, patients seemed to recover consciousness faster and look like they were feeling better. To present, there is little information on the effect of sugammadex on awakening from anaesthesia.

The quality of postoperative recovery focused around patient-oriented endpoints has raised new interest as a measure of the quality of anaesthesia and a target towards which improvement can be directed.

On the other hand, there is no single prospective study performed to address a possible effect of sugammadex on recovery from anaesthesia.

The objective of this study was to compare the effect of sugammadex and neostigmine on the quality of postoperative recovery using the PQRS in elderly patients undergoing trans pars plana vitrectomy with general anesthesia


Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged over 60 years who are scheduled for trans pars plana vitrectomy with general anesthesia

Exclusion Criteria:

* Neuromuscular disease
* History of malignant hyperthermia
* Significant renal or hepatic dysfunction
* Allergy to sugammadex or rocuronium
* BMI \> 30kg/m2
* History of medication which affect neuromuscular blocker such as anti-convulsants, magnesium
SCLERoderma et Adipose-DErived Stroma Cells

Systemic sclerosis (SSc) is an auto-immune orphan disease mainly characterized by an alteration of the microvascular network, and by cutaneous and visceral fibrosis. Hands are frequently affected, as a consequence of ischemic phenomena and cutaneous fibrosis. As a result, patients suffer from everyday disability, with consequences on their occupational activities and social contact, sometimes severely altering their quality of life. To date, no anti-fibrosis treatment has proven effective; existing vasodilation treatments are unfortunately not very effective, and are associated with adverse effects or restrictions. It is consequently of utmost importance that an effective treatment for sclerodermic hands be developed. The injection of adipose autologous tissue is a common practice in plastic surgery, and has been known for over a century. Adipose tissue, originally used to increase volume, is also characterized by trophic properties associated to stromal vascular fraction (SVF), which contain multipotent stem cells, capable of tissue repair. Interestingly, some SVF cells can be angiogenic and anti-inflammatory, which could improve damage seen with SSc. The injection of SVF into the fingers would also make it possible to control the production of the extracellular matrix and to improve the balance between fibrosis and fibrolysis, resulting in an improvement of cutaneous sclerosis

The main purpose is to evaluate the efficacy of SVF injections in the fingers of patients suffering from SSc on the Cochin hand functional scale evaluated at 12 months, in comparison to the control group.


Eligibility Criteria:
Inclusion Criteria:

* Systemic Sclerosis ( limited or diffuse cutaneous shape)
* Men and women of more than 18 years old
* Patients wishing for a therapeutic alternative
* Functional Disability of the dominant hand authenticated by a functional index of the hand of Cochin functional scale upper to 20

Exclusion Criteria:

* Body mass index (weight in kilograms divided by height in meters squared) lower than 18
* Finger infection (including infected ulcer, ulcer with signs of local inflammation and clinical suspicion of osteitis)
* Contraindication to surgery
* Prescription of a new systemic treatment for SSc in the month before the inclusion Subjects infected with HIV, HCV ( hepatitis C virus) , HBV (hepatitis B virus), HTLV ( human T-cell leukemia virus) and syphilis
* Pre-menopausal women of reproductive age, taking no contraceptive method
* Patients receiving immunosuppressive therapy not including corticosteroid therapy \< 10 mg/D and methotrexate
Efficacy of a Novel Fluoride Varnish in Preventing WSL During/After Treatment With Fixed Orthodontic Appliances

The aim of the present study is to evaluate the efficacy of a novel fluoride varnish (NFV) in preventing white spot lesion development in adolescents during and after treatment with fixed orthodontic appliances.

The study will employ a double-blind, randomized placebo-controlled design with two parallel groups. The intervention will start at onset of the fixed appliances and will be finalized one year after debonding. The primary outcome will be incidence of white spot lesions on the labial surfaces of the maxillary incisors, canines and premolars, as assessed from high-resolution digital photos. The secondary outcome is the prevalence of WSLs at debonding.

During the course of the orthodontic treatment, the patients are regularly checked every 6th week. At the end of each such occasion, the clinical staff will apply either the test or the placebo varnish with a small brush in a thin layer around the base of the braces on the maxillary teeth.

The pre- and post-treatment photos are projected on a screen (Hewlett Packard ProBook 6650b, Palo Alto CA, USA) in a dark room and the incidence and severity of enamel demineralization will be registered independently by two experienced and calibrated orthodontists according to the index of Gorelick et al. (1982).

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criterion is a scheduled treatment with fixed maxillary appliances according a standard straight-wire concept (McLaughlin et al., 2001) during a period of at least 12 months

Exclusion Criteria:

* In the event of long-term prescriptions of general antibiotics during the course of the study, this should be recorded separately
Safety and Efficacy of Clopidogrel for Cerebral Infarction Treatment

The primary objective is to compare the safety of clopidogrel 50mg and 75mg in cerebral infarction with respect to incidence of bleeding adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Patients with an episode of cerebral infarction (excluding cardiogenic cerebral thromboembolism) occurring at least 8 days prior to randomization and for whom the clinical course up to randomization is well-documented
* Patients with a cerebral infarct confirmed by Computed Tomography or Magnetic Resonance Image
* Body weight : \> 50 kg

Exclusion Criteria:

* Patients with cardiogenic cerebral thromboembolism or disease that could precipitate cardiogenic cerebral thromboembolism, such as atrial fibrillation or valvular hear disease (including valve replacement)
* Patients with Transient Ischemic Attack occuring after the last episode of cerebral infarction
* Patients with serious impairment that would hinder detection of new ischemic event
* Patients with bleeding diathesis, coagulopathy, or hemorrhagic disease
* Patients with history of intracranial hemorrhage
* Patients with diabetic retinopathy
* Hypertensive patients with a persistent increase of blood pressure.
PRESERVE-Zenith® Iliac Branch System Clinical Extended Study

The PRESERVE-Zenith® Iliac Branch System Clinical Study is a clinical trial to collect confirmatory safety and effectiveness data on the Zenith® Branch Endovascular Graft-Iliac Bifurcation System. This system is made up of two devices: the Zenith® Branch Endovascular Graft-Iliac Bifurcation and the ConnectSX™ covered stent in the treatment of aorto-iliac and iliac aneurysms


Eligibility Criteria:
Inclusion Criteria:

* An aortioiliac or iliac aneurysm
* An unsuitable distal sealing site for a traditional Zenith iliac leg graft within the common lilac artery

Exclusion Criteria:

* Less than 18 years of age
* Inability or refusal to give informed consent
* Disease considerations that would compromise patient safety or study outcomes
* Unsuitable arterial anatomy