cyrilzakka/clinical-trials huggingface dataset:
Impact of Increased Immunoglobulin E to Anti-herpes Simplex Virus -1 Innate Immune Responses in Atopic Dermatitis Patients With Eczema Herpeticum

This study investigates whether blood monocytes' surface bound- immunoglobulin E affects the innate immune responses against herpes simplex viruses in atopic dermatitis patients with eczema herpeticum.

Some of atopic dermatitis patients (AD) have severe herpes simplex viral (HSV) infections, which could cause erosive skin lesions all over the body. This condition is termed as eczema herpeticum (ADEH+). Scientists have found that ADEH+ patients have significantly increased blood immunoglobulin (Ig) E compared to AD patients without eczema herpeticum and healthy people. Increased IgE in blood could bound to immune cells' surface, such as monocytes. Since monocytes serve as the first line defense to fight viral infection, their surface-bound IgE may interfere their anti-viral immune responses, and consequently results in more severe viral infections. The purpose of this study is to learn more about how increased IgE affect body's immune ability to fight herpes simplex viruses. This study includes three groups: AD patient without eczema herpeticum complication(ADEH-); AD patient with eczema herpeticum complication(ADEH+) and healthy controls. Study results will be compared between groups.

Eligibility Criteria:
Inclusion Criteria:

* Age 16-65 years old, age, sex and race match among non-atopic, ADEH- and ADEH+.
* Participant and/or parent guardian must be able to understand and provide informed consent, and fits in one of the following conditions:

  1. A history of AD with a history of eczema herpeticum, ADEH+, as diagnosed using the Atopic Dermatitis Research Network Standard Diagnostic Criteria.
  2. A history of AD without a history of eczema herpeticum, ADEH-, as diagnosed using Atopic Dermatitis Research Network Standard Diagnostic Criteria, and no first degree relatives with a history of EH.
  3. Non-atopic as diagnosed using Atopic Dermatitis Research Network Standard Diagnostic Criteria.

Exclusion Criteria:

* Inability or unwillingness of a participant to give written informed consent or comply with study protocol
* Known or suspected immunosuppression
* Severe concomitant illness(es)
* Women of childbearing potential not using the contraception method(s) specified in this study (specify), as well as women who are breastfeeding
* Known sensitivity to study drug(s) or class of study drug(s)
* Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required)
* Use of any other investigational agent in the last 30 days
JAYDESS Drug Utilization Study in Sweden

* To describe characteristics (demographic, clinical, social) of first time users of Jaydess
* To estimate the duration of use of Jaydess
* To study switching patterns, e.g. what are the hormonal contraceptive methods used before and what are the methods after discontinuing Jaydess
* To study off-label use of Jaydess


Eligibility Criteria:
Inclusion Criteria:

* Swedish women who were dispensed a JAYDESS from a Swedish Pharmacy anytime 2014-2017

Exclusion Criteria:

No exclusion criteria
Pharmacokinetic Interactions of Candesartan Cilexetil and Amlodipine Besylate

This study is designated to evaluate the pharmacokinetic interactions of candesartan cilexetil and amlodipine besylate in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Male volunteers in the age between 20 and 55 years old(inclusive)
* Body mass index (BMI) in the range of 18.5 to 27 kg/m2(inclusive)
* Available for the entire study period
* Understand the requirements of the study and voluntarily consent to participate in the study

Exclusion Criteria:

* Subjects with a history of gastrointestinal diseases which might significantly change ADME of medicines
* Systolic blood pressure outside the range of 100 to 150 mmHg or diastolic blood pressure outside the range of 60 to 1000 mmHg for male subjects. when screening period
* Subject with symptoms of acute disease within 14days prior to study medication dosing
* Subjects with a history of clinically significant allergies
* Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
* Subjects whose clinical laboratory test values are outside the accepted normal range(Especially,AST or ALT \>1.5 times to normal range or total bilirubin \> 1.5times to normal range)
* History of drug abuse
* History of caffeine, alcohol, smoking abuse

  * caffeine(coffee,tea,coke) or grapefruit juice \> 4cups/day
  * smoking \> 20 cigarettes/day
  * alcohol \> 140g/week
* Positive test results for HBs Ab, HCV Ab, Syphilis regain test
* Participation in any clinical investigation within 30days prior to study medication dosing
* Subjects with whole blood donation within 60days, component blood donation within 30days and blood transfusion within 30days prior to study medication dosing
* Subjects considered as unsuitable based on medical judgement by investigators
T&B Depletion Non Malignant

• The primary aim of the present trial is to assess in a randomized fashion the benefit on standard graft-versus-host disease (GVHD) prophylaxis of the addition of ATG-Fresenius S ® in transplants from matched related donors (MRD) and of anti-CD20 rituximab in transplants from matched unrelated donors (MUD). Both safety and efficacy of the treatment will be assessed, in particular in respect to the clinical status of the patient, i.e. prevention of graft failure and chronic GvHD and of Ebstein Barr virus (EBV) viremia for MUD patients.

The conditioning proposed combines myeloablative drugs with a favorable safety profile such as treosulfan, thiotepa (Tepadina®) and fludarabine with the intent to reduce the traditional immediate and late toxicity of busulfan and cyclophosphamide.

For patients transplanted from a MRD

The primary end-point is the cumulative incidence of a combined end-point defined as the time from randomization to:

* primary and secondary graft failure,
* aGVHD II-IV,
* cGVHD,
* death, whichever occurs first.

For patients transplanted from a MUD

The primary end-point is the cumulative incidence of a combined end-point defined as the time from randomization to:

* aGVHD II-IV,
* EBV viremia, whichever occurs first.

Eligibility Criteria:
Inclusion Criteria:

* non malignant haematological and inherited metabolic disorders benefiting from an allogeneic HSCT conditioned with a myeloablative regimen
* Availability of a matched related donor (MRD) or Matched Unrelated Donor (MUD)
* Lansky or Karnofsky Index ≥ 60
* Inherited metabolic disorders: DQ ≥ 70 (+ MRI Loes score ≤ 9 for adrenoleukodystrophy)
* Adequate cardiac, renal, hepatic and pulmonary functions as evidenced by:
* Serum creatinine ≤ 1.5 × upper limit of normal (ULN)
* Heart shortening fraction (left-ventricle) \> 28 % or LVEF \> 55%
* Serum bilirubin ≤ 1.5 × ULN (except for Wolman disease),
* AST and ALT ≤ 2.5 × ULN (except for thalassemic syndromes and Wolman disease)
* Pulmonary function: if cooperative: FEV1 and FVC on pulmonary function testing \> 60 %; if non cooperative: pulse oximetry \> 95 % in room air
* Availability of autologous back up marrow (\> 2 x 108 TNC+ cells/kg or \> 2 x 106 CD34+ cells/kg) for MUD
* Adequate contraception in female patients of child-bearing potential
* Signed informed consent

Exclusion Criteria:

* Any malignancy
* Liver cirrhosis evidenced on liver histology (performed in suspicious cases or in case of Wolman disease)
* HIV- positivity
* Clinically significant pleural effusion or ascites
* Pregnancy or lactation
* Known hypersensitivity to trial drugs
* Participation in another experimental drug trial in the 2 months preceding enrollment
* Non-cooperative behaviour or non-compliance
* Previous HSCT
Clinical Evaluation of Two Daily Disposable Lenses in Sphere Design

This was a single-blind, interventional, prospective, direct refit, bilateral wear, fixed-sequence crossover study.

The aim of this study was to evaluate the visual performance and subjective experiences of daily disposable hydrogel lens (DDH) when compared to daily disposable silicone hydrogel lens (DDSH) after 15 minutes of daily wear each.

Eligibility Criteria:
Inclusion Criteria:

* Is at least 18 years of age and has full legal capacity to volunteer.
* Has read and signed an information consent letter.
* Self-reports having a full eye examination in the previous two years.
* Anticipates being able to wear the study lenses for the required time of the study.
* Is willing and able to follow instructions and maintain the appointment schedule.
* Has refractive astigmatism no higher than -0.75 DC.
* Can be fit with the available lens parameters (sphere +8.00 to -10.00D).
* Can achieve binocular distance vision of at least 20/30 Snellen (logMAR 0.18) with the study contact lenses.

Exclusion Criteria:

* Is participating in any concurrent clinical or research study.
* Has any known active ocular disease and/or infection that contraindicates contact lens wear.
* Has a systemic condition that in the opinion of the investigator may affect a study outcome variable.
* Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable.
* Has known sensitivity to the diagnostic sodium fluorescein used in the study.
* Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment.
* Has undergone refractive error surgery or intraocular surgery.
Impact of Corpus Luteum Presence or Absence in the Incidence of Preeclampsia After Frozen Embryo Transfer

Identifying modifiable factors that contribute to preeclampsia risk associated with assisted reproduction can improve maternal health. Recent studies have shown an increased risk for hypertensive disorders of pregnancy after in vitro fertilization, particularly for pregnancies occurring during a hormone replacement therapy such a donor egg recipient and a frozen embryo transfer. This risk may be partly attributable to the degree by which the assisted reproductive treatment affects the maternal hormonal environment, when the corpus luteum is a major source of reproductive hormones. On the other hand, cryopreserved embryos are usually thawed and replaced in in a natural or hormonally manipulated cycle; on this point, frozen embryo transfer is associated with better perinatal outcome regarding preterm birth and low birth weight yet higher risk of large for gestational age and macrosomia compared to fresh transfer. The objective of our study is to investigate whether the absence of corpus luteum adversely affects pregnancy and to analyse if there are differences in the perinatal outcomes due to differences in the endometrial preparation protocol for a frozen embryo transfer.


Eligibility Criteria:
Inclusion criteria

* All patients who, after IVF-PGT-A treatment with their own oocytes, present a euploid embryo for transfer.
* Transfer of a single euploid embryo

Exclusion criteria:

* Moderate or high smoking (\> 5 cigarettes/day)
* BMI ≥30 kg/m2
* Chronic hypertension
* History of preeclampsia in previous pregnancies
* History of delayed uterine growth and placental insufficiency in previous pregnancies
* Use of donor sperm
* Woman's age ≥44 years
* Women with menstrual cycles longer than 35 days
Descriptive Study of Multiligamentary Reconstruction of the Knee

Evaluation of clinical results and postoperative laxity after single-stage reconstruction of multiligamentous lesions of the knee. Comparison of two types of transplant: allograft versus autograft.

There is currently little data in the clinical outcome literature after allograft reconstruction. There is one study reporting postoperative laxity assessed by dynamic radiography in the four planes (anterior, posterior, varus, valgus). No study compares postoperative laxity after allograft versus autograft reconstruction.


Eligibility Criteria:
Inclusion Criteria:

* Patients operated for one-time allograft or autograft reconstruction of multiligamentous knee injury
* \>18 years old

Exclusion Criteria:

* Neurological or vascular injury during trauma.
* Fracture of the femur or both bones of the leg.
* Ligamentous lesion on the contralateral knee.
* History of surgery on the affected knee.
Safety and Efficacy of Triple Combination Therapy in Patients With Glaucoma or Ocular Hypertension

This study will investigate the safety and efficacy of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) in patients with glaucoma or ocular hypertension who have elevated intraocular pressure (IOP) on brimonidine/timolol ophthalmic solution.


Eligibility Criteria:
Inclusion Criteria:

* Glaucoma and/or ocular hypertension in both eyes
* Requires IOP-lowering treatment in both eyes

Exclusion Criteria:

* Other active ocular disease other than glaucoma or ocular hypertension (eg, uveitis, ocular infections or severe dry eye)
* Current or anticipated use of ocular medications other than study medications, except for intermittent use of artificial tears
* Use of oral, injectable or topical corticosteroids within 21 days
* Iridectomy or laser peripheral iridotomy in the study eye within 3 months
* Uncomplicated cataract surgery in the study eye within 6 months
* Incisional glaucoma surgery in the study eye within 12 months
Surgical Treatment of Hydatid Liver Disease

The goal of this observational study is to show that cyst extraction with pericyst reduction and omentopexy is a suitable treatment for liver hydatid disease caused by E.Granulossus with a low rate of complication and recurrence.


Eligibility Criteria:
Inclusion Criteria:

* hydatid liver disease

Exclusion Criteria:

* hydatid disease present outside the liver
A Clinical Study on LM103 Injection for the Treatment of Advanced Solid Tumors

This study is an open exploratory clinical study to evaluate the safety, tolerance, immune response, and initial efficacy of autologous tumor infiltrating lymphocyte LM103 injection in advanced solid tumor patients. The research treatment includes fludarabine and cyclophosphamide, autologous tumor infiltrating lymphocytes (TILs) infusion, and Interleukin-2 therapy.


Eligibility Criteria:
Inclusion Criteria:

1. The expected survival time is not less than 6 months.
2. Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0-1.
3. Patients with advanced solid tumors confirmed by histology or cytology: advanced Melanoma, head and neck squamous cell cancer, soft tissue sarcoma and other solid tumors that have failed standard treatment regimens, cannot tolerate standard treatment, refuse or do not have standard treatment regimens available.
4. The patient has lesions that can be used for surgical resection (\>1.5 cm\^3) or biopsy puncture (no less than 6 lesions) for TILs collection.
5. At least one measurable lesion as the target lesion after collecting tumor tissue from the patient (RECIST v1.1 criteria).
6. Laboratory tests results during the screening period indicate that the subjects have sufficient organ function.

Exclusion Criteria:

1. Have a medical history of other malignant tumors other than the disease under study in the past 5 years, except for malignant tumors that can be expected to recover after treatment (including but not limited to thyroid cancer, cervical Carcinoma in situ, basal or squamous cell skin cancer or Ductal carcinoma in situ of the breast treated by radical surgery).
2. LM103 received systematic Sex therapy of antineoplastic drugs (including chemotherapy, small molecule targeted drug therapy, Hormone replacement therapy, etc.), or local antineoplastic therapy (such as radiotherapy, palliative radiotherapy for bone metastases\>2 weeks before the start of the study and intracranial stereotactic radiotherapy or resection of a single brain metastasis\>3 weeks before the start of the study were acceptable) within 4 weeks before LM103 infusion; Or received clinical investigational drugs or equipment treatment.
3. Adverse reactions caused by previous treatment have not recovered to CTCAE (version 5.0) level 1 or below (excluding hair loss and neurotoxicity, which have been determined by the researchers to be irreparable and level 2 hypothyroidism for a long time).
4. Previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
A Study of SPY002-091 in Healthy Volunteers

This is a Phase 1, randomized, double-blind, placebo-controlled, single- dose, first in human safety, tolerability, and pharmacokinetic study of SPY002-091 in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* Willing and able to attend the necessary visits to the CRU, comply with all testing requirements, remain at the study site unit for the duration of the confinement period and return for the outpatient visits

Exclusion Criteria:

* Participation in more than one cohort
* Evidence of clinically significant abnormality or disease
* Known history of illicit drug use or drug abuse, harmful alcohol use or alcoholism, and/or smoking or nicotine-containing product use within 3 months prior to the first dose of study drug
* History of severe allergic reactions or hypersensitivity
* Donation or loss of \>1 unit of whole blood within 1 month prior to dosing
Using Continuous Glucose Monitoring to Quantify the Effects of NOURISH's Culturally Modified Meals on Asian Americans With Type 2 Diabetes

The investigators are hoping to determine whether tailoring the diet of someone with type 2 diabetes to their ethnic group while following American Diabetes Association guidelines can make a significant difference in their blood sugar controls. Participants will be required to wear a Continuous Glucose Monitor (CGM) for 1-month so that the investigators can compare blood sugar levels when participants are eating their routine diet vs. the culturally tailored diabetes diet.

This clinical trial evaluates the impact of culturally tailored, American Diabetes Association (ADA)-compliant meals on the glycemic control of Asian Indian and Filipino individuals with Type 2 Diabetes Mellitus (T2DM). This study leverages a crossover design to compare glycemic responses during two distinct dietary phases: a self-selected diet phase (baseline/control/routine diet) and an intervention phase featuring NOURISH meals. NOURISH Meals will be delivered to designated pick-up points on the Stanford campus and Stanford clinics. Participants will be equipped with Continuous Glucose Monitors (CGMs) to track glucose trends across the study and will be required to keep a food log through Tastermonial, enabling detailed analysis of postprandial glucose responses and key metrics.

Eligibility Criteria:
Inclusion Criteria:

* Self-identification as Asian Indian or Filipino
* Diagnosed with T2DM
* Can pick up meals from a designated area on the Stanford Campus
* Willing to wear a CGM for 30 days

Exclusion Criteria:

* Currently taking insulin, GLP -1 and SGLT 2
* Known severe allergic reactions and/or food intolerances that would interfere with the ability to eat
* Those who, in the opinion of the investigators, cannot reliably complete the study protocol.
A Comparative Study of LY900014 With Insulin Lispro (Humalog) in Participants With Type 2 Diabetes Mellitus (T2DM)

The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which is a drug that lowers blood sugar. The study will look at how the body processes LY900014, and the effect of LY900014 on blood sugar levels following a standard meal. For each participant, the study will consist of 4 periods and will last approximately 12 weeks from screening to final study follow up.


Eligibility Criteria:
Inclusion Criteria:

* Have a body mass index (BMI) of 18.5 kilogram per meter square (kg/m²) to 40.0 kg/m²
* Have a glycated hemoglobin (HbA1c) less than or equal to (≤)9.0%
* Have a fasting C-peptide ≤1.0 nanomole per liter (nmol/L)
* Are on stable prandial insulin and basal insulin (neutral protamine Hagedorn \[NPH\] insulin, insulin glargine or insulin detemir) with or without a stable dose of metformin for at least 3 months before screening

Exclusion Criteria:

* Are currently enrolled, or have participated within the last 30 days, in a clinical trial or any other type of medical research
* Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate in the study
* Have donated blood of more than 450 millilitre (mL) or more in the last 3 months or provided any blood donation within the last month before screening
* Any significant changes in insulin regimen and/or unstable blood glucose control within the past 3 months prior to screening as assessed by the investigator
* Are treated with a CSII (insulin pump)
* Require daily insulin treatment greater than (\>)1.2 units per kilogram per body weight (U/kg/body weight)
Duodenal tIssue ResEction aCquisiTion (DIRECT) Study

To evaluate the quality of cold snare resection specimens of duodenal mucosa tissue in patients undergoing an upper gastrointestinal interventional endoscopy in order to improve the processing of histological samples and its assessment in general and for future duodenal ablation studies.

The duodenum plays an important role in metabolic health. There is evidence that the duodenal mucosa undergoes certain histological changes in the development of features of the metabolic syndrome and ultimately type 2 diabetes (T2D). To date, it is not known exactly what type of histological changes the duodenal mucosa undergoes in T2D, so elucidating these changes may lead to a better understanding and potentially new treatment options for metabolic syndrome and T2D.

The assessment of histological changes in tissue obtained from duodenal biopsies has proven to be very difficult due to the lack of orientation in the histological slides obtained. The investigators have learned that duodenal biopsies are too small and superficial to reliably assess histological changes in the duodenal mucosa and submucosa. Currently, the investigators are taking small cold snare resections from the duodenum to try to fully assess the duodenal (sub)mucosa. However, the investigators still have problems with the orientation of these resections. When slides are made, the specimens are curled, cut tangentially and artefacts occurr. As a result, it is still not possible to make a proper assessment of the duodenal (sub)mucosa.

Therefore, the investigators aim to optimise the process of obtaining, storing, processing and staining the duodenal mucosal tissue samples from cold snare resections. The investigators plan to optimise this process in patients who have already undergone upper gastrointestinal interventional endoscopy, including ablation therapy, endoscopic submucosal dissection (ESD) or endoscopic mucosal resection (EMR) for Barrett's neoplasia and squamous cell carcinoma of the oesophagus or small gastric neoplasia, or oesophageal dilatations, as the endoscopist performing DMR in the Netherlands also specialises in these endoscopic treatments. By studying the process of obtaining duodenal mucosal tissue samples in this specific patient population, there is no need to expose other patients to an upper gastrointestinal endoscopy with the associated propofol sedation.

Eligibility Criteria:
Inclusion Criteria:

* Already scheduled to undergo an upper gastrointestinal interventional endoscopy
* Endoscopy under deep sedation (propofol) in Amsterdam UMC

Exclusion Criteria:

* Previous GI surgery that could affect the ability to reach the duodenum via endoscopy, such as Bilroth 2, Roux-en-Y gastric bypass, or other similar procedures or condition
* History of duodenal inflammatory diseases including Crohn's Disease and Celiac Disease