cyrilzakka/clinical-trials huggingface dataset:
A Study of Baricitinib (LY3009104) in Participants With Moderate-to-Severe Atopic Dermatitis

The purpose of this study is to evaluate the safety and effectiveness of Baricitinib in eczema.


Eligibility Criteria:
Inclusion Criteria:

* Have moderate-to-severe Atopic Dermatitis (AD), as determined by all of the following:

  1. EASI of 12 or more
  2. Greater than or equal to 10% of body surface area involvement
  3. Diagnosed with AD at least 2 years prior
* Have a history of inadequate clinical response to other eczema treatments

Exclusion Criteria:

* Females who are pregnant or nursing
* Participants who do not agree to use adequate contraception
* Are currently experiencing or have a history of:

  * Skin conditions such as psoriasis or lupus erythematosus
  * Skin disease that requires frequent hospitalizations or intravenous treatment
  * Compromised immunity
* Serious illness that could interfere with study participation, or a clinically important deviation in physical examination, vital sign measurements, electrocardiograms, or abnormalities on laboratory tests
* Currently experiencing or have a history of:

  * Active or latent Tuberculosis or specific immunity disorders and infections
  * Malignancy or lymphoproliferative diseases in the last 5 years (or cervical, basal or squamous skin cancer re-occurrence in the last 3 years)
  * Human Immunodeficiency Virus (HIV)
  * Hepatitis B, Hepatitis C, or chronic liver disease
* Have received certain types of vaccinations
Phase 2b Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group Study to Assess the PD Response and Safety of Three Dose Levels of (PB1023) Injection Following 20 Weeks of Weekly SC Dosing in Adults With T2DM

Primary objective:

The primary objective of this study is to define the dose response of Glymera as measured as the change from baseline in hemoglobin A1c (HbA1c) following 20 weeks of once-weekly dosing.

Secondary objectives:

The secondary objectives are to:

* Describe incidence, severity, and duration of reported gastrointestinal side effects of Glymera compared to active comparator;
* Compare change from baseline in HbA1c following 20 weeks of dosing compared to placebo and active comparator;
* Compare change from baseline in fasting plasma glucose (FPG) following 20 weeks of dosing compared to placebo and active comparator;
* Describe the frequencies of adverse events in the treatment groups; and
* Describe the above endpoints for the following subgroups of subjects according to baseline type 2 diabetes mellitus (T2DM) therapy: diet and exercise only, metformin only, sulfonylurea only, or metformin and sulfonylurea combination therapy.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects 18 to 75 years of age, inclusive;
* Body mass index ≤45 kg/m2;
* Diagnosed with T2DM with HbA1c of ≥7.0% and ≤11.0% and treated with diet and exercise alone, or with stable doses of metformin alone, sulfonylurea alone or metformin and sulfonylurea.

Exclusion Criteria:

* Currently taking or have taken within the last 6 months non-oral antihyperglycemic agents (eg, insulin, Byetta®, Bydureon®, or Victoza). Short-term use of insulin within this period will not be cause for exclusion if insulin was used during the treatment of an acute intercurrent illness;
* Known allergy to or serious adverse effect caused by an approved or investigational glucagon-like peptide-1 (GLP-1) receptor analog/agonist;
* Unstable cardiovascular disease;
* History of weight loss surgery or other gastrointestinal surgical procedures that could possibly interfere with the mechanism of action of GLP-1 receptor agonists;
* Based on contraindications/warnings identified with other GLP-1 receptor agonists, subjects will be excluded if they have: History, symptoms, or signs of pancreatitis or severe gastrointestinal disease (ie, gastroparesis) or Personal or family history of medullary thyroid tumors or history of Multiple Endocrine Neoplasia Syndrome Type 2;
* Clinically significant renal and/or hepatic dysfunction;
* Pregnant or lactating female subjects.
Probiotics in IgA Nephropathy

Recent studies have shown an increased gastrointestinal reactivity and increased intestinal permeability in IgA nephropathy (IgAN). Probiotic supplementation is known to impact the gastrointestinal immune system possibly by improvement of both the immunologic and the non-immunologic intestinal barrier. Probiotic supplementation should thus theoretically have an effect on IgAN. In this study the investigators will study the efficacy and safety of Lactobacillus reuteri.


Eligibility Criteria:
Inclusion Criteria:

* Above 18 years
* Primary IgAN, verified by biopsy
* Albuminuria \> 0.75 g/24 h (verified by at least four sample results within a two years period prior to inclusion)
* Serum creatinine less than 200 umol/L (verified by at least four sample results within a two years period prior to inclusion)
* Having signed informed consent form

Exclusion Criteria:

* Participation in another clinical intervention trial
* Patients with celiac disease
* Patients with secondary IgAN
* Creatinine clearance below 30 ml/min (mean of 3 measurements)
* Introduction of an ACE inhibitor or angiotensin II receptor blocker during the last three months prior to inclusion
* Patients treated with immunosuppressive or systemic corticosteroid drugs within the last twelve months
* Patients using probiotic products within the last three months (includes probiotic milk products)
* Known allergy or intolerance to any of the ingredients in the probiotic product
Study of Acalabrutinib in Chinese Adult Subjects With Relapsed or Refractory Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia or Other B-cell Malignancies

This is an open-label, two-part study to assess the safety, tolerability, pharmacokinetics and clinical efficacy of acalabrutinib in Chinese adult subjects with R/R MCL, CLL and other B-cell malignancies. The study is divided into 2 parts: Phase 1 portion and Phase 2 portion.


Eligibility Criteria:
Inclusion Criteria

1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
2. Chinese subjects at least 18 years of age at the time of study entry.
3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
4. Adequate hematological and organ function.
5. Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy.
6. Pathologically confirmed MCL, with documentation of chromosome translocation t(11;14) (q13;q32) and/or overexpression of cyclin D1 in association with other relevant markers (eg, CD5, CD19, CD20, PAX5). Disease had relapsed after or been refractory to previous treatment.
7. Diagnosis of CLL that meets published diagnostic criteria. Must have received ≥ 1 prior systemic therapies for CLL.
8. Active disease per iwCLL 2018 criteria that requires treatment. (CLL only)
9. Other relapsed/refractory B-cell malignancies without stand of care (phase 1 only).

Exclusion criteria

1. Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject had been disease free for ≥2 years or which would not have limited survival to \<2 years.
2. Significant cardiovascular disease.
3. Known central nervous system involvement of lymphoma/leukemia or leptomeningeal disease.
4. Known history of HIV, serologic status reflecting active hepatitis B or C infection.
5. Major surgery within 4 weeks before first dose of study drugs.
6. Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura.
7. Required or received anticoagulation with warfarin or equivalent vitamin K antagonist (eg, phenprocoumon).
8. Prior exposure to a BCR or BCL-2 inhibitor.
9. Use of a strong inhibitor or inducer of CYP3A.
10. Breastfeeding or pregnant.
Epidemiological Investigation of Helicobacter Pylori-infected Patients and the Effect of Eradication Treatment on Dyspepsia Symptoms

The objectives of this multicenter, prospective, observational study were to investigate the incidence of dyspeptic symptoms in patients with Helicobacter pylori (H. pylori) infection and to continuously follow up the remission of dyspeptic symptoms after H. pylori eradication, so as to provide reference for the clinical diagnosis and treatment strategies of patients with H. pylori infection and dyspeptic symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged 18-80 years
* H. pylori infection diagnosed by 13C/ 14C-UBT (\> 2 times the cutoff value) and/or gastroscopy (rapid urease strong positive and histological positive)
* Treatment-naive patients with Helicobacter pylori
* Ability and willingness to participate in the study and to sign and give informed consent

Exclusion Criteria:

* Under 18 or over 80 years old
* Organic digestive diseases, such as active peptic ulcer, gastroesophageal reflux, gastrointestinal bleeding, acute/chronic pancreatitis, acute/chronic cholecystitis, gallstones, intestinal obstruction, inflammatory bowel disease, etc.
* Combined with melena, hematemesis, anemia, emaciation and other alarm symptoms
* Pregnant and lactating women
* History of cancer
* History of subtotal gastrectomy
* Severe organ dysfunction of heart, liver, kidney, lung and other important organs and congenital diseases, such as grade IV heart failure, liver failure, uremia, respiratory failure, hemophilia, Wilson's disease, etc.
Dyadic Life Review Intervention for Older Patients with Advanced Cancer) and Their Caregivers

The purpose of this study is to test the feasibility of a pilot Randomized Controlled Trial (RCT) comparing Dyadic Life Review (DLR) intervention in older adults with advanced cancer and their caregivers to Care-as-Usual (CAU) group, which involves a referral to social work.

The purpose of this study is to test the feasibility of a pilot Randomized Controlled Trial (RCT) comparing Dyadic Life Review (DLR) intervention in older adults with advanced cancer and their caregivers to Care-as-Usual (CAU) group, which involves a referral to social work. The study will enroll dyads (pairs) of caregivers and older patients with advanced cancer and dyads of caregivers and patients with advanced cancer. A previous single-arm study was performed testing the feasibility of the adapted DLR intervention in older adults with advanced cancer and their caregivers. The single-arm pilot demonstrated DLR was feasible and acceptable by both patients and caregivers. This innovative pilot study will gather data to test the feasibility of a pilot and examine pre-post intervention changes in caregiver psychological distress.

Eligibility Criteria:
Patient Inclusion Criteria:

* Age ≥ 65
* Within 180 days of Stage III or IV advanced cancer diagnosis, any type of cancer
* Score of 4 or more on National Comprehensive Cancer Network (NCCN) Distress Thermometer (DT)\*
* Able to read and understand English

Patient Exclusion Criteria:

• Unable to identify caregiver to participate in study

Caregiver Inclusion Criteria:

* One caregiver for each patient will be eligible and must be chosen by the patient. For the purposes of this study, a caregiver is defined as a valued and trusted person in a patient's life who is supportive in health care matters by providing valuable social support and/or direct assistive care.
* Caregivers will be selected by the patient when asked if there is a "significant other, spouse, or romantic partner with whom you discuss or who can be helpful in health-related matters;" patients who cannot identify such a person ("caregiver") will remain eligible for the study.
* Age 50 or older
* Able to read and understand English

Caregiver Exclusion Criteria:

• Caregivers unable to provide consent
Cortisol and the Formation of Intrusive Memories

Intrusive memories of traumatic events are core features of posttraumatic stress disorder (PTSD) but little is known about the neurobiological formation of intrusions. The aim of this study was to determine whether cortisol levels during an intrusion-inducing stressor influence subsequent intrusive memories.

The investigators conducted an experimental, double-blind, placebo-controlled study in 60 healthy women. Prior to watching an established trauma film paradigm that induces short lasting intrusions, participants received a single dose of either 10 mg hydrocortisone or placebo. The number of consecutive intrusions of the trauma film, the mean vividness of the intrusions and the mean degree of distress evoked by the intrusions were assessed during the following seven days. Salivary cortisol and alpha-amylase were collected at seven time points prior to, and after the trauma film.

Eligibility Criteria:
Inclusion Criteria:

* healthy participants
* German on a native level

Exclusion Criteria:

* former or present DSM IV Axis I disorders
* physical illnesses
* any medication intake (except oral contraceptive)
* history of sexual abuse or rape
* pregnancy or lactation period
Responses of People With Neck Pain Being Treated With Varying Doses of Manual Therapy: A Pilot Study

The purpose of this pilot project is to determine the feasibility of a study design to investigate how many sessions of manual therapy and exercise produce the best results for people with whiplash injuries. Also, this study will help us determine the best way to measure the effect of treatment. Finally, the investigators will study how closely the physiotherapists follow the treatment instruction provided in the study protocol and training. In order to achieve these objectives, 12 people will receive manual therapy and exercise at one of twelve different doses. the investigators will have each of these people fill out questionnaires, measure sensation changes, and measure changes in the way people move their necks while walking. This study will help us determine if the study protocol can be carried out as planned. This includes: the training of all people involved in carrying out the assessments and treatments, the willingness and ability of participants to take part in all of the treatment and measures involved. This will provide us with important information to help us plan a larger study with 226 people with whiplash injuries.


Eligibility Criteria:
Inclusion Criteria:

* adults ≥ 21 years
* main complaint must be neck pain, but we expect some patients will also report symptoms that radiate to the shoulder and arm regions or have an associated headache.
* pain intensity must be ≥ 12/40 on the 4-item pain scale (P4).

Exclusion Criteria:

* non-mechanical sources of neck pain or over-riding comorbidity listed below:
* rheumatoid arthritis
* neurological diseases
* fractures
* dislocation
* rheumatoid arthritis
* upper motor neuron dysfunction or malignancy
* pregnant women
* closed head injury
* on steroid-based medications within the past 6 months.
A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE)

The reason for this long term study is to see how safe and effective the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE) who have completed the final treatment visit of study I4V-MC-JAHZ (NCT03616912) or study I4V-MC-JAIA (NCT03616964).


Eligibility Criteria:
Inclusion Criteria:

* Have completed the final treatment study visit of an originating study, such as study JAHZ (NCT03616912) or Study JAIA (NCT03616964).
Flow-flow ECCO2-R and 4 ml/kg Tidal Volume vs. 6 ml/kg Tidal Volume to Enhance Protection From VILI in Acute Lung Injury

The main objective of this randomized multicenter clinical trial is to test the hypothesis that further reduction of VT to 4mL/kg may enhance lung protection in patients with ARDS as compared to the conventional "ARDS-Net" ventilation. Control of PaCO2 in the \~4 ml/kg arm would be accomplished by LFPPV- ECCO2-R.

The trial will test the hypothesis that a VT of 4 ml/kg PBW combined with low flow CO2 removal improves outcome in patients with severe ARDS (PFs ≤ 200 and PEEP ≥ 10) compared to ventilation with a VT of 6 ml/kg PBW. The study will accrue a maximum of 230 patients over approximately 12-18 months.

PRIMARY END-POINT: Number of ventilator-free days (VFDs) during the 28 days immediately after randomization

SECONDARY END-POINTS: 28 and 90-day all-cause mortality; number of ICU-free days during the 28 days immediately after randomization; cumulative incidence of: first episode of refractory hypoxemia (during 28 days after randomization), use of rescue therapies, first day that meet criteria for weaning, SOFA-free and severe adverse events.

Patients in CONTROL will be treated according to a modified, simplified version of The ARDS-Network lung protective lower tidal volume. Patients in TREATMENT group will be treated according to the ARDS-Net protocol modified (VT reduced by 1 ml/kg PBW at intervals ≤ 2 hours until VT = 4ml/kg PBW and the use of low-flow CO2 removal with a Plateau Pressure Goal: ≤ 25 cm H2O).

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* are on invasive assisted breathing less then 48 hours
* less than 24 hours since diagnosis for ARDS: with PF\<=200 and PEEP\>=10, bilateral infiltrate on chest X-Ray and no clinical evidence of left atrial hypertension
* have a commitment to full support

Exclusion Criteria:

* intubation and mechanical ventilation (any form) for \> 48 hours
* risk of systemic bleeding with anticoagulation
* acute brain injury
* body mass index \> 40
* neuromuscular disease that impairs ability to ventilate without assistance
* severe chronic respiratory disease
* burns \> 40% total body surface area
* malignancy or other irreversible disease or condition for which 6- month mortality is estimated to be greater than 50%
* allogeneic bone marrow transplant within the last 5 years
* chronic respiratory condition making patient respirator dependent
* patient, surrogate, or physician not committed to full support
* acute myocardial infarction or acute coronary syndrome within 30 days
* moribund patient: not expected to survive 24 hours
* no consent/inability to obtain consent
* patients receiving high frequency ventilation
A Preliminary Study on Digital Learning Aids for Special Children With TRIZ and 3D Printing Technology

During the transition phase from early intervention to primary education (4.5 years to 8.11 years), children with special needs may encounter difficulties in using digital learning media. The investigators intend to apply the TRIZ analysis method to enhance children's participation in learning. Additionally, the investigators plan to design a preliminary model of learning aids and conduct a trial.

The design of digital learning aids for early childhood education for special children to participate in classroom learning is based on the principle of TRIZ analysis combined with the design of 3D printing technology to explore the needs and design of digital apparatus for early childhood education for special children to participate in classroom learning.

A exploratory study. Part 1: Analysis of Systematic Questionnaires. Thirty questionnaires were collected from users of learning devices based on the theoretical basis of ACCESS-FM.The results of the questionnaire are based on the theoretical concept analysis of TRIZ and are used for the preliminary design of learning aids.Part 2: Analysis of Assistive Device Trial. Five school-age children were recruited from the questionnaires for the preliminary design of learning aids. The results are collected for the digital platform performance (writing and typing tests), the ABILHAND-Kids, the Berry-Buktenica Developmental Test of Visual-Motor Integration, Motor Coordination, and the Children's Learning Devices. Motor Integration, Motor Coordination), the Movement Assessment Battery for Children for Children, Second Edition, the Quebec User Evaluation of Satisfaction with Assistive Technology; QUEST) and side effects.

Data Analysis: The performance and side effects of the digital platform operations before and after training were compared using Wilcoxon Signed Ranked Test. SPSS 20.0 was used and the level of statistically significant difference was set at Alpha\<0.05.

Eligibility Criteria:
Inclusion Criteria:

Analysis of Systematic Questionnaires part

* the caregiver of a child with special needs in early care;
* the caregiver or child has trouble using electronic devices or needs;
* the child can cooperate with the full questionnaire;
* the child with special needs in early care attends school. Analysis of Assistive Device Trial part
* Special children aged 6 to 9 years who are currently receiving early intervention;
* Children who experience difficulties or have needs related to using electronic devices;
* Participants who are able to complete the trial sessions;
* Special children receiving early intervention who are attending school.

Exclusion Criteria:

Analysis of Systematic Questionnaires part

* The child is younger than 4.5 years old or older than 9 years old;
* The caregiver is unable to communicate and read in Chinese.

Analysis of Assistive Device Trial part

* Children younger than 6 years or older than 9 years of age;
* Children who are unable to recognize Zhuyin (Bopomofo) phonetic symbols.
Does Knowing One's Estimated Colorectal Cancer Risk Influence Screening Behavior?

This study is designed to examine the impact of telephone-based colorectal cancer risk assessment on colorectal screening attitudes and behavior among previously unscreened adults ages 50 to 75.

Colorectal cancer (CRC) remains the 3rd most common cancer in the US. Most CRCs are preventable, but screening participation remains suboptimal. Several factors have been associated with screening compliance, such as perception of CRC risk. Here we study the impact of telephone-based administration of the National Cancer Institute Colorectal Cancer Risk Assessment Tool (CCRAT) compared to usual care.

Eligibility Criteria:
Inclusion Criteria:

* Patient of any participating physician
* Not having had any colorectal cancer screening test prior
* Able to speak English

Exclusion Criteria:

* Personal history of inflammatory bowel disease
* Personal history of colorectal cancer
* Personal history of Lynch syndrome or Familial Adenomatous Polyposis
* Have already received colorectal cancer screening
Study Of PF-03084014 In Combination With Gemcitabine And Nab-Paclitaxel In Patients With Metastatic Pancreatic Adenocarcinoma Not Previously Treated With Anticancer Therapies

This study consists of a Phase 1b portion aimed to determine the maximum tolerated dose and the safety profile of PF-03084014 in combination with gemcitabine and nab-paclitaxel followed by a Phase 2 portion to evaluate the efficacy of the triple combination in terms of overall survival in patients with metastatic pancreatic ductal adenocarcinoma not previously treated with anticancer therapies.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically diagnosis of metastatic ductal adenocarcinoma of the pancreas.
* No prior radiotherapy, surgery chemotherapy or investigational therapy for metastatic disease. Prior adjuvant therapy with 5-FU or gemcitabine (± gemcitabine post radiation) administered as radiosensitizer allowed, provided at least 6 months have elapsed between the last dose and study registration
* Tumor tissue available (Archival 6 months old or de novo biopsy)
* Measurable disease as per RECIST 1.1
* Performance Status (ECOG) 0 or 1

Exclusion Criteria:

* Symptomatic brain metastases requiring steroids
* Prior therapy with gamma secretase inhibitors or other Notch pathway inhibitor
* Major surgery within 4 weeks of registration in the current study
* Known hypersensitivity to gemcitabine or nab-paclitaxel or any of the excipients
* Current or anticipated need for food or drugs that are strong/moderate CYP3A4 inhibitors or inducers
* Diagnosis of any second malignancy within 3 years prior to registration