cyrilzakka/clinical-trials huggingface dataset:
PD-1 Antibody for Reactive EBV After BMT

PD-1 antibody for reactivation of EBV after transplantation in patients with CAEBV/EBV-HLH

Transplantaion is recongnized as a cure for CAEBV and EBV associated HLH，however, many patients undergo the reactivation of EBV after transpaltion, patiens may at high risk for recurrence of the disease. PD-1 is a promising therapy to solve this problem.

The present study was a one-arm clinical study, the main subject is to evaluate the effect of PD-1 antibody on the clearance of EBV

Eligibility Criteria:
Inclusion Criteria:

1. Meet hemophagocytic lymphohistiocytosis (HLH)-04 diagnostic criteria; EBV-DNA in peripheral blood or EBER in tissue were positive, patients were diagnosed with EBV associated HLH (EBV-HLH). Chronic active EBV infection (CAEBV) was diagnosed by WHO criteria.
2. Undergo allo-HCT, have achieved full chimerism
3. Age \>18 years old, gender is not limited.
4. After transplantation, EBV was reactivated and EBV-DNA was positive in blood
5. No secondary graft failure. (After grafted, ANC \<0.5\*10\^9/l,PLT \<10\*10\^9/l)
6. No uncontrollable infection
7. Withdraw immunosuppressor, no graft-versus-host disease was observed.
8. Before the start of the study, aminopherase (ALT/AST) and total bilirubin were normal. Serum creatinine ≤ 1.5 times the upper limit of Normal (ULN); No thyroid dysfunction. The left ventricular ejection fraction (LVEF) was normal.
9. Informed consent.

Exclusion Criteria:

1. Allergic to toripalimab
2. Serious immunoreaction: myocardial damage, hepatitis, pneumonia
3. Central nervous system symptoms
4. Serious mental illness;
5. Active bleeding of the internal organs
6. Pancreatitis history. Patients unable to comply during the trial and/or follow-up phase;
7. Participate in other clinical research at the same time.
Intralesional Injection of Acyclovir Versus Candida Antigen in Treatment of Plantar Warts

This study aims to evaluate the efficacy of intralesional injection of acyclovir versus candida antigen in plantar wart patients will be randomly divided into 2 groups,At least 20 patients will be enrolled in each group.

Group 1: will be treated with intralesional injection of acyclovir 250 mg acyclovir vial diluted with 3.5 ml saline to get approximately 70 mg/ml solution. The base of each wart was injected with 0.1 ml of intralesional acyclovir (70 mg/ml) every 2 weeks until the resolution of warts or for a maximum of 5 sessions Group 2: will be treated by intralesional Candida antigen injection (candida antigen ) at a dose of 0.2 mL. injected into the largest wart every 2 weeks until complete clearance of warts or for a maximum of 5 treatment sessions.

3.Patient evaluation: Assessment of treatment efficacy and side effects will be carried out by clinical examination and comparative photographic evaluation and dermoscopy

patients will be randomly divided into 2 groups, group (1) and group (2). At least 20 patients will be enrolled in each group.

Group 1: will be treated with intralesional injection of acyclovir (Acyclovir 250mg Powder for Solution for Infusion, each vial contains 250mg of acyclovir as the sodium salt, Chandra Bhagat Pharma Pvt. Ltd) 250 mg acyclovir vial diluted with 3.5 ml saline to get approximately 70 mg/ml solution. During the study, the dosage of the drug and frequency of treatment were uniform in all patients. The base of each wart was injected with 0.1 ml of intralesional acyclovir (70 mg/ml) using an insulin syringe (29 Gage × 0.5-in) every 2 weeks until the resolution of warts or for a maximum of 5 sessions

Group 2: will be treated by intralesional Candida antigen injection (candida antigen ) at a dose of 0.2 mL. injected into the largest wart using an insulin syringe (29 Gage × 0.5-in) every 2 weeks until complete clearance of warts or for a maximum of 5 treatment sessions.

patients will be followed up for 3months after treatment.

Eligibility Criteria:
Inclusion Criteria:

* The study will include patients with single or multiple planter wart. Age group 18:50 years old

Exclusion Criteria:

* : patients with history of renal or liver disease, pregnant and lactating females, patients taking immunosuppressant drugs, patients who received any treatment for wart in the last month before the study.
Mediterranean-style Dietary Pattern (MDP), Mood and Anxiety

Observational studies and a limited numbers of RCTs have observed that habitual Mediterranean-style dietary pattern (MDP) consumption is associated with improved mental health and cognition. Yet, its efficacy in a short-term has not been studied in well-controlled intervention settings.

MediMood is a cross-over RCT aiming to test whether a MDP can affect mood and anxiety following a meal (postprandial) and over 5-days in adults over 18 years with mild to moderate mental health problems relative to a Western diet (WD).

Depression, anxiety and age-related cognitive decline are leading global public health problems. A plant-based Mediterranean-style dietary pattern (MDP) includes olive oil as the main source of fat, fresh fruits, vegetables, seafood, legumes and nuts and a low consumption of red and processed meat, confectionary, and high-sugar drinks. A MDP promotes both physical and mental wellbeing and brain function. However, most studies to date have examined the impact of a MDP on health over months or years. As several underpinning biological mechanisms are likely to be responsive within hours or days, examining the short-term effect of a MDP on mental health outcomes is important. The overall goal of the present study is to understand the effects of a MDP on acute/sub-chronic brain health and its underpinning mechanisms.

MediMood is a randomised cross-over efficacy trial. Participants will be assigned to an isocaloric MDP and a Western diet (WD) for 5-days in a random order with a 4-week wash-out period. All foods, meal plans and detailed dietary instructions will be provided. In addition to the primary outcome measures (mood and anxiety), the impact of intervention on cognitive performance, sleep, cerebral blood flow (MRI) and a selection of biomarkers of brain function will be measured in biological samples over five days.

As low mood, anxiety and stress disorders affect daily functioning and reduce the quality of life significantly for many, the investigators believe the findings will have wide public health application.

Eligibility Criteria:
Inclusion Criteria:

* Male and female, aged 18 or above
* Is willing and able to comply with all study procedures, including changes in diets
* Has access to and able to use the internet/computer/tablet device
* Mild to moderate level of anxiety and/or depression symptoms, assessed by Generalised Anxiety disorder (GAD-7) score and Patient Health Questionnaire (PHQ-9), scores 5 to 14 on both questionnaires
* A habitual MEDAS score of ≤ 7/14
* To be fluent in English

Exclusion Criteria:

* MEDAS score \>7
* Vegan/vegetarian
* Allergies to one of the study components i.e. nuts, fish
* On antidepressant or antianxiety medication where dosage is likely to change over the next 3 month
* Factors precluding MRI scanning such as suffers from claustrophobia or has metal implants
* Not fluent in English
* Not agreement for the study team to contact the participants general practitioner about trial participation and screening results
* Not prepared to make changes to the diet for 10 days (2 x 5 day periods)
Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis

The AIR-BX2 study enrolled people with non-cystic fibrosis (non-CF) bronchiectasis and gram-negative airway infection. Participants received two 28-day courses of either Aztreonam for Inhalation Solution (AZLI) or placebo taken 3 times a day. Each course was followed by a 28-day off-drug period. Following the two blinded courses, all participants received a 28-day course of open-label AZLI then were followed for an additional 56 days.


Eligibility Criteria:
Inclusion Criteria:

* Male/Female 18 years or older with non-CF bronchiectasis
* Chronic sputum production on most days
* Positive sputum culture for gram-negative organisms
* Must have met lung function requirements

Exclusion Criteria:

* History of CF
* Hospitalized within 14 days prior to joining the study
* Previous exposure to AZLI
* Pregnant, breastfeeding, or unwilling to follow contraceptive measures for the study
* Must have met liver and kidney function requirements
* Continuous oxygen use of greater than 2 liters per minute (supplemental oxygen with activity and at night was allowed)
* Treatment for nontuberculous mycobacteria infection or active mycobacterium tuberculosis infection within 1 year of enrollment
* Other serious medical conditions.
Infection With Unknown Origin in the Emergency Department

Patients suspected with infection is one of the major groups, who are admitted to the Danish Emergency Departments (ED). Currently, there is no overall description of the distribution of these infections. The aim of this study is to characterize ED patients with a suspected infection whereby the focus of the infection is of an unknown origin.

Bacteria resistant to antibiotics are associated with high antibiotic consumption and are identified by the World Health Organisation as a major public health threat. Despite efforts to optimize antibiotic consumption in Denmark, the total consumption in the hospital sector increased from 2009-2018 and the incidence of multi-resistance bacteria (MRB) is increasing. A Danish multicenter study has shown that every 20th patient in the emergency department has MRB. Patients with an infection of unknown origin tend to be prescribed a broad-spectrum antibiotic, as physicians endeavour to target probable origins in the body. The uncertainty associated with the diagnosis may lead to an overconsumption of antibiotics, which contributes to increased development of resistant bacteria and threatens future treatment options.

The aim of this study is to characterize patients admitted to the ED suspected with infection. The study will have three objectives:

* To describe the distribution of ED infections according to the registered diagnosis in the medical record compared to a clinical expert panel assessment
* To identify clinically relevant information available at admission associated with a patients infection of unknown origin.
* To investigate the association between an adverse event and clinically relevant information for patients with infection of unknown origin

The investigators' hypothesis is that with an improvement of knowledge about patients with an infection of unknown origin, a more accurate diagnosis can be made leading to a more appropriate antibiotic therapy and contributing to the fight against resistance to antibiotics.

Eligibility Criteria:
Inclusion Criteria:

* Adults admitted to the ED will be invited to participate in the study, if the physician, receiving the patient, suspect the patient has an infection (e.g. indication for blood culture).

Exclusion Criteria:

* If the attending physician considers that participation will delay a life-saving treatment or patient needs direct transfer to the intensive care unit.
* Admission within the last 14 days
* Verified COVID-19 disease within 14 days before admission
* Pregnant women
* Severe immunodeficiencies: Primary immunodeficiencies and secondary immunodeficiencies (HIV positive CD4 \<200, Patients receiving immunosuppressive treatment (ATC L04A), Corticosteroid treatment (\>20 mg/day prednisone or equivalent for \>14 days within the last 30 days), Chemotherapy within 30 days)
Brimonidine in Rosacea

Rosacea is a chronic and relapsing inflammatory cutaneous disorder with highly variable prevalence worldwide.

In our study, we will compare the safety, efficacy, and adverse effects of low-dose oral doxycycline alone versus combined with pulsed dye laser or topical brimonidine in treating erythematotelangiectatic rosacea in an attempt to build a treatment strategy in a disease with complex pathogenesis.

Eligibility Criteria:
Inclusion Criteria:

* Patient with current erythematotelangiectatic rosacea

Exclusion Criteria:

- Pregnant females. 2-Patients on systemic steroids. 3-Patients complaining of other dermatological disorders mainly photosensitive cutaneous disorder.

4- Patients receiving any systemic treatment including retinoids for the previous 1 month or any topical treatment for the previous 2 weeks or any laser sessions for the previous 3months for erythematotelangiectatic rosacea at least.
A Study to Evaluate Zilebesiran in Japanese Patients With Mild to Moderate Hypertension

The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacodynamics (PD) and pharmacokinetics (PK) of zilebesiran in Japanese patients with mild to moderate hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Must have been born in Japan, and their biological parents and grandparents must have been of Japanese origin
* Has mean systolic office blood pressure (SBP) of \>130 and \<=165 mmHg by automated office blood pressure measurement, after a minimum of 3 weeks of washout if taking hypertensive medication
* Has 24-hour mean SBP ≥130 mmHg by ambulatory blood pressure monitoring (ABPM), without antihypertensive medication

Exclusion Criteria:

* Has secondary hypertension, symptomatic orthostatic hypotension
* Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2× upper limit of normal (ULN)
* Has elevated serum potassium \>5 mmol/L
* Has estimated glomerular filtration rate (eGFR) of \<60 mL/min/1.73m\^2
* Has received an investigational agent within the last 30 days
* Has Type 1 diabetes mellitus, poorly controlled Type 2 diabetes mellitus or newly diagnosed Type 2 diabetes mellitus
* Has history of intolerance to SC injection(s)
Validity and Reliability of the Dual-task Questionnaire

It is important to increase the independence of Multiple Sclerosis (MS) patients in activities of daily living. Almost all activities of daily living require managing many activities at the same time. For example, walking or standing while talking on the phone. There is a need for easily applicable, reliable and valid scales to evaluate dual-task performance in MS patients. Therefore, the aim of this study is to establish the Turkish cultural adaptation, validity and reliability of the Dual-Task Questionnaire scale in MS patients. This study included a total of 50 patients with MS \[age (18-65) years\]. Dual-task Questionnaire (DTQ), Timed Up and Go test (TUG) with dual-task and Nine Hole Peg test (9-HPT) with dual-task were applied to the patients. The second evaluation (retest) was carried out by the same physiotherapist one week following the first evaluation (test) in order to measure test-retest reliability.

This study included patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS). DTQ was used to assess the frequency of difficulties associated with daily tasks involving the dual-task. Additionally TUG with dual-task and 9-HPT with dual-task were applied to the patients. An experienced physiotherapist applied all these tests. In order to measure test-retest reliability, a retest was carried out by the same physiotherapist one week following the first evaluation. The construct validity of DTQ was tested by Pearson's correlation coefficient.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Multiple Sclerosis
* Must be able to ambulatory status (Expanded Disability Status Scale score ≤ 6 )
* No relapse in the last 3 mounts

Exclusion Criteria:

* Orthopedic problems
* Visual, perception, and hearing problems
A Study of GDC-0575 Alone and in Combination With Gemcitabine in Participants With Refractory Solid Tumors or Lymphoma

This open-label, multicenter, Phase I, dose-escalation study will evaluate the safety, tolerability, and pharmacokinetics (PK) of GDC-0575 administered alone or in combination with gemcitabine in participants with refractory solid tumors or lymphoma. In Stage 1, cohorts of participants will receive multiple ascending oral doses of GDC-0575 alone or in combination with intravenous gemcitabine. In Stage 2, participants will receive GDC-0575 orally in combination with intravenous gemcitabine at or below the maximum tolerated dose determined in Stage 1. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs, up to approximately 5 years.


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Histologically or cytologically documented, locally advanced or metastatic solid tumors or lymphoma for which standard therapy either does not exist or has proven ineffective or intolerable
* Life expectancy greater than or equal to (\>=) 12 weeks, in the opinion of the investigator
* Adequate hematologic, liver, and renal function
* For Stage 2: Participants with human epidermal growth factor receptor 2 (HER2) negative, estrogen-receptor (ER) negative, and progesterone-receptor (PR) negative breast cancer
* For Stage 2: Participants with non-mucinous, platinum-resistant ovarian cancer with documented radiographic progression or relapse according to RECIST within 6 months of receiving platinum-based chemotherapy
* For Stage 2: Participants with histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (NSCLC); mixed histology that is predominantly squamous is acceptable

Exclusion Criteria:

* History of prior significant toxicity from a same class of agents as GDC-0575 or gemcitabine requiring discontinuation of treatment
* All acute toxicities related to prior therapy must have resolved prior to study entry, except for alopecia and mild neuropathy
* Current severe, uncontrolled systemic disease (including but not limited to clinically significant cardiovascular, pulmonary, or renal disease or ongoing or active infection) excluding the cancer under study
* History of significant cardiac dysfunction
* History of malabsorption or other condition that would interfere with enteral absorption
* Known human immunodeficiency virus (HIV) infection
* Pregnancy, lactation or breastfeeding
* Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms
* Current use of alpha-adrenergic receptor blockers

For Combination Arm only:

* Any contraindication to gemcitabine therapy
* More than two regimens of cytotoxic chemotherapy for the treatment of locally advanced or metastatic cancer
* History of receiving high-dose chemotherapy requiring bone marrow or stem cell support
* Irradiation to more than 25% of bone marrow-bearing areas
Safety and Preliminary Effectiveness of the BaroSense Articulating Circular Endoscopic (ACE) Stapler for Plication of Dilated Post-surgical Gastric Anatomy

The BaroSense Articulating Circular Endoscopic (ACE) Stapler is an investigational instrument indicated for endoluminal trans-oral tissue approximation and ligation in the gastrointestinal tract. This study explores the specific application of tissue apposition in dilated post-surgical gastric anatomy such as observed in a dilated Roux-en-Y Gastric Bypass (RYGB) pouch.

The primary objective of this study is to perform an evaluation of the safety of the ACE Stapler for the treatment of dilated post-surgical gastric anatomy.

The secondary objective of this study is to evaluate the preliminary efficacy of the ACE Stapler for the treatment of dilated post-surgical gastric anatomy over a 12 month follow-up period.


Eligibility Criteria:
Inclusion Criteria:

1. Subject, male or female, is age 18 to 60 years of age.
2. Subject must be able to understand and be willing to sign an informed consent document.
3. Subject must be willing and able to participate in all aspects of the study and agree to comply with all study requirements for the duration of the study. This includes availability of reliable transportation and sufficient time to attend all follow-up visits.
4. Subject must be \> 2 years post RYGB surgery.
5. Subject must have documented records indicating an initial achievement of \> 60% EWL (based on an ideal weight of 25 BMI) at some point after RYGB surgery.
6. Subject has a BMI at baseline of \> 30 and \< 50.
7. At time of enrollment, subject must have regained at least 35% of the maximum weight lost following RYGB, and the weight regain must have occurred over a period of not less than 3 months from the point of maximum weight loss.
8. Subject must have a stoma diameter of at least 18 mm.
9. Subject must be fully ambulatory, without chronic reliance on walking aids such as crutches, walkers or a wheelchair.

Exclusion Criteria:

1. Subject has a severe eating disorder.
2. Investigator determines that there is another causal factor for the subject's weight regain other than dilated gastric anatomy.
3. Subject has previously undergone an endoscopic or surgical repair of dilated pouch or stoma (including sclerotherapy treatments).
4. Subject had irreversible or life threatening complications following initial RYGB procedure (cardio or respiratory).
5. Subject has an ongoing severe complication from their initial RYGB procedure (recurrent ventral hernia, pain syndrome, etc.).
6. Subject has an intragastric fistula, anastomotic leak, or staple/suture line disruption.
7. Subject has history of/or signs and/or symptoms of gastro-duodenal ulcer disease.
8. Subject has symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.
9. Subject has pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer.
A Study of LY3819469 in Healthy Participants

This is a 2-part study. In Part A, the main purpose is to evaluate the safety and tolerability of the study drug LY3819469 in healthy participants with high lipoprotein (a) \[Lp(a)\] levels. How the body processes the study drug and the effect of the study drug on blood Lp(a) levels will also be investigated. Part B will mainly evaluate the safety and tolerability of LY3819469 as well as how the body processes the study drug in Japanese participants. The study may last up to 53 and 29 weeks for each participant in Parts A and B, respectively.


Eligibility Criteria:
Inclusion Criteria:

* Female participants must not be able to get pregnant and male participants must agree to adhere to contraception restrictions
* Have a body mass index (BMI) of 18.5 to 40.0 kilograms per square meter (kg/m²)
* For Part B, participants should be of first-generation Japanese origin

Exclusion Criteria:

* Are currently participating in or completed a clinical trial within the last 30 days
* Are heavy alcohol drinkers or heavy cigarette smokers
* Have donated blood of more than 500 milliliters (mL) in the last 3 months