cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Safety and Efficacy of a Tacrolimus New Oral Formulation (MR4) in BMT Patients-Extension-

To assess safety and efficacy of the patients with MR4 therapy in GVHD prophylaxis study who are eligible for the administration after 100 days post transplant (up to 1 year)


Eligibility Criteria:
Inclusion Criteria:

* Patient had enrolled in GVHD prophylaxis study.
* Patient had been fully informed.

Exclusion Criteria:

* The patient had been not eligible for the administration after 100 days post transplant in the investigator's judgement.
Benefit of IQP-VV-102 in Reducing Postprandial Glucose Level in Overweight Caucasian Subjects

In this trial, the investigational product , the active ingredients which has been proven to reduce postprandial glucose in healthy and diabetic patients, will be tested. The primary aim of this clinical study is to evaluate the possibility of the investigational product to reduce the rise of postprandial glucose AUC level in overweight Caucasian subjects with normal to prediabetic biomarkers (IFG/HbA1C), without prompting a disproportionate rise in insulin levels.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian
* BMI between ≥ 25 and \< 30 kg/m2
* Normal to prediabetic biomarkers: FBG 3.9-6.9 mmol/L / 70-125mg/dL and HbA1c 4-6.4%
* Willing to take test meal and adhere to consumptions of pre-prepared meals supplied (controlled by subject diary)
* Willing to maintain same level of physical activity during the study
* Willing to arrive at the study site with the same, non-strenuous means of transportation during the study
* Negative pregnancy testing (beta hCG) for women of childbearing potential during screening
* Women of child-bearing potential have to agree to use appropriate birth control methods during the study period
* Written informed consent of the subject to participate is a prerequisite for study participation

Exclusion Criteria:

* Known sensitivity to L-arabinose and grape marc extracts, or any sources of the active ingredients and excipients
* Use of medications or dietary supplements that may influence body weight 4 weeks, and gastrointestinal functions 2 weeks prior to enrolment and during the study
* Use of anti-diabetic medication
* Strenuous exercise within one day prior to blood glucose sampling (including screening).
* History of bariatric surgery, small bowel resection, or extensive bowel resection
* Difficult veins
* Recent blood donation in the last 1 month prior to study
* Pregnancy or nursing
* Clinically relevant excursions of safety parameters
* Any other serious condition or disease that renders subjects ineligible
* Smoking
* Exceeding safe alcohol consumption (men: ≥ 21 units/week; women: ≥ 14 units/week) and any alcohol consumption within 24 hours before venous blood glucose sampling
* All vegetarians and subjects with self-reported diet high in fat or protein
* Subjects are not able to communicate with local study staff
* Recent antibiotic and cortisone use up to one week and during the study
* Participation in another study during the last 30 days of the screening visit (V1)
A Prospective Study of Diet and Cancer in Members of the American Association of Retired Persons

This is a prospective cohort study of diet and cancer in relation to several major cancers, especially breast, prostate, and colorectal malignancies. The cohort comprises 50-69 year-old male and female members of the American Association of Retired Persons (AARP). In 1995-6 we mailed baseline questionnaires to 3.5 million AARP members. Over 615,000 AARP members responded, with over 540,000 providing adequate dietary data. Preliminary analysis indicates that the cohort, both men and women, has the desired wide distributions of percent calories from fat, dietary fiber, fruits and vegetables, and red meat. Approximately 330,000 of the initial respondents (with satisfactory data) returned a second questionnaire containing questions on exposures not assessed in the first instrument.

In terms of field activities, the study has been relatively quiescent over the past year. At the end of the five-year period of observation, we will mail to cohort members a brief follow-up questionnaire primarily targeted to endpoint assessment. (Because of cancer registry lag-time, we do not expect to mail this questionnaire until early 2002.) Follow-up will be largely passive, through established state registries. The initial questionnaire mailing will be to AARP members in those states selected on the basis of having registries with adequate coverage and quality. We will use active follow-up, with record retrieval, for the small percentage of cohort members who have moved out of the cancer registry areas. The buccal cell collection pilot study has been completed; over 50% of those pilot study partricipants who had completed the baseline and risk factor questionnaires returned buccal cell speciments. Preliminary data from a pilot study of the end point ascertainment procedure indicate that cohort incidence rates for major cancers, determined from registry data, are consistent with SEER rates.

This is a prospective cohort study to investigate relations among diet, lifestyle and cancer. The cohort comprises 50-69 year-old male and female members of the American Association of Retired Persons (AARP). In 1995-96 we mailed baseline questionnaires to 3.5 million AARP members. Over 615,000 AARP members responded, with over 540,000 providing adequate dietary data. Preliminary analysis indicates that the cohort, both men and women, has the desired wide distributions of percent calories from fat, dietary fiber, fruits and vegetables, and red meat. Approximately 330,000 of the initial respondents (with satisfactory data) returned a second questionnaire containing questions on exposures not assessed in the first instrument. In 2004-2006 we mailed a follow-up questionnaire to all living participants to assess non-cancer endpoints and lifestyle factors.

Eligibility Criteria:
* INCLUSION CRITERIA:

Patients participating will be selected from the American Association of Retired Persons age 50-69 living in one of the following state and metropolitan areas: California (minus Los Angeles county), Florida, Pennsylvania, New Jersey, Louisiana, North Carolina, Detroit, and Atlanta.
Steroid-induced Reduction of Surgical Stress Study

The stress response as induced by myocardial cellular damage during cardiac surgery may lead to myocardial stunning and apoptosis, and could therefore impair postoperative patient recovery. Surgical trauma typically induces the liberation of cytokines. Some of these cytokines are strongly associated with the initiation of intracellular proapoptotic pathways through activation of tyrosine kinases and integrins. The latter are known for their deteriorating effects on cardiac function and are strongly involved in cardiac remodeling. Dexamethasone is typically administered prior to cardiac surgery in order to especially reduce the release of proinflammatory cytokines. It has however never been investigated whether this additionally reduces proapoptotic signaling in the human heart, thereby eliminating risk factors for the induction of cardiac dysfunction. In the present study, the investigators therefore aim to investigate whether dexamethasone inhibits proapoptotic pathways in patients undergoing cardiac surgery. Furthermore, the investigators would like to elucidate whether this proposed effect of dexamethasone is related to the reduction of the stress response in the heart or indirectly by suppression of cytokine release. For this purpose the investigators will obtain cardiac biopsies and plasma from patients, who are randomly assigned to placebo or dexamethasone treatment and undergo on and off-pump coronary artery bypass grafting (CABG) surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing coronary artery bypass surgery (CABG)
* Age 18-75 years
* Informed consent

Exclusion Criteria:

* Re-operations and emergency operations
* Patient with anemia (Hb \< 5.0)
* Emergency operation
* Patients receiving blood transfusions \< 3 months before operation
* Insulin depended diabetes mellitus
* Hepatic or renal failure
* Pregnancy
* Use of steroids
A Dose Determination and Safety Study of X4P-001 (Mavorixafor) in Participants With Warts, Hypogammaglobulinemia, Infections, and Myelokathexis (WHIM) Syndrome

This is a Phase 2 study with an initial 24-week Treatment Period and an Extension Phase. The primary objectives of this Phase 2 study are to determine the safety, tolerability, and dose selection of mavorixafor in participants with WHIM syndrome. Participants may continue treatment in an Extension Phase, if regionally applicable, until mavorixafor becomes available via an alternative mechanism (for example, drug is commercially available, an expanded access program, etc.) or until the study is terminated by the Sponsor for any reason.


Eligibility Criteria:
Inclusion Criteria:

Participants with a clinical diagnosis of WHIM syndrome must meet all of the following criteria to be eligible for study participation:

1. Be at least 18 years of age.
2. Has signed the current approved informed consent form.
3. Has a genotype-confirmed mutation of chemokine receptor type 4 (CXCR4) consistent with WHIM syndrome.
4. Agree to use effective contraception.
5. Be willing and able to comply with this protocol.
6. Has confirmed ANC less than or equal to (≤) 400/µL or ALC ≤650/µL or both.

Exclusion Criteria:

Participants with any of the following will be excluded from participation in the study:

1. Has known systemic hypersensitivity to the mavorixafor drug substance or its inactive ingredients.
2. Is pregnant or nursing.
3. Has a known history of a positive serology or viral load for human immunodeficiency virus (HIV) or a known history of acquired immunodeficiency syndrome (AIDS).
4. Has, at Screening, laboratory tests meeting one or more of the following criteria:

   * A positive antibody test for hepatitis C virus (HCV), unless documented to have no detectable viral load on 2 independent samples.
   * A positive test for hepatitis B surface antigen (HBsAg).
5. Has any medical or personal condition that, in the opinion of the Investigator, may potentially compromise the safety or compliance of the participant, or may preclude the participant's successful completion of the clinical study.
Safety and Efficacy of Longterm HPN With Two Lipid Emulsions

It is the purpose of this trial to provide evidence for safety and efficacy of long term home parenteral nutrition with either Lipofundin MCT or Lipoplus in patients with proven insufficient enteral resorption.

Long term parenteral nutrition is indicated in the home care setting of patients who are unable to completely cover their daily caloric requirements by oral/enteral nutrition due to e.g. pre existing malnutrition or compromised intestinal absorption.

An appropriate nutritional supplementation ensuring the provision of patients basic requirement of amino acids, glucose, lipids, micronutrients and electrolytes is therefore required to stop weight loss, increase quality of life and to reduce unfavorable consequences of malnutrition in those patients.

Major causes for malnutrition and compromised intestinal absorption are malignant processes. Tumor cachexia, weight loss due to insufficient nutrition of \< 60 -80 % of the calculated substrate need for \> 14 days, antineoplastic therapy and surgical intervention are consequences of the malignant disease and lead to catabolic processes.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Age: 18-80 years
* Male and female patients
* Patients with a newly indicated need of long-term home parenteral nutrition (HPN) for at least 8 weeks
* Patients with an insufficient resorption capacity of the colon that may not be compensated by enteral nutrition
* mentally and physically able to adhere to study procedures.
* Females agree to apply adequate contraception

Exclusion Criteria:

* Participation in a clinical study with an investigational drug within one month prior to the start of study
* Patients with sepsis, severe sepsis and septic shock
* Known or suspected drug abuse
* General contra indications for infusion therapy such as acute pulmonary edema, hyperhydration and decompensated cardiac insufficiency
* Pregnancy and lactation
* Autoimmune disease as e.g. HIV
* Known hypersensitivity to egg-, soy-, and fish proteins or any of the ingredients
* Hemodynamic failure of any origin (hemorrhagic shock, myocardial infarction, cardiac failure)
* Alterations of coagulation (thrombocytes \<150.000 mm3), PT \< 50%, PTT \> 40 sec
* Diabetes mellitus with known ketoacidosis within 7 days before onset of study
* Renal insufficiency with serum creatinine \> 1.4 mg/dL(\>124 mmol/L)
* Patients with severe liver dysfunction with bilirubin \>2.5 mg/dL (\> 43 µmol/L)
* Lipid disorders, in particular fasting serum triglycerides \> 250 mg/dL (\>2.86 mmol/L)
* necrotizing pancreatitis
A Clinical Study of SHP674 (Pegaspargase) in Participants With Newly Diagnosed, Untreated Acute Lymphoblastic Leukemia

The objectives of the study are to assess the safety and tolerability of a single dose of SHP674 in Japanese participants (dose confirmation) in the tolerability assessment period of Part 1 and to assess the safety, pharmacokinetics and efficacy of SHP674 dose in Part 2 (found to be tolerated in Part 1) in the treatment of newly diagnosed untreated acute lymphoblastic leukemia (ALL) in Japanese participants.


Eligibility Criteria:
Inclusion Criteria:

* Age 1 to ≤21 years at the time of informed consent;
* Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 2;
* Newly diagnosed, untreated precursor B-cell ALL
* No prior therapy for malignant tumor such as chemotherapy and radiation therapy before signing the informed consent;
* Life expectancy of at least 6 months from the date of enrollment;

Exclusion Criteria:

* Mature B-cell ALL ; Philadelphia chromosome-positive (Ph+) or BCR-ABL1-positive ALL
* Preexisting known coagulopathy ;
* History of pancreatitis;
* Continuous use of corticosteroids;
* Prior treatment or possible prior treatment with an L-asparaginase preparation;
* History of sensitivity to polyethylene glycol (PEG) or PEG-based drugs;
* Pregnant
Additional Effect of Forward Head Posture Correction on Temporomandibular Dysfunction

The goal of this clinical trial is to test the additional correction effect of nerd neck on damaged jaw in people who suffers from jaw problems and nerd neck at the same time. The main question it aims to answer:

• whether the additional correction of nerd neck impact the jaw features of pain and function.

Participants will:

* participants will be given the consent to sign first.
* participants will be assessed to check jaw pain and function.
* participants will be divided randomly into 2 groups.
* Each group will be given the treatment sessions for 6 weeks.
* participants will come back after 6 weeks for another last assessment. Researchers will compare regular treatment for Jaw with new device, regular only and dental treatment groups to see if there is improvement in jaw characteristics.

The relationship between the two conditions of forward head posture (FHP) and temporomandibular joint dysfunction (TMD) have been previously stated with comparing the craniocervical angle (CVA) of TMD patients to the healthy individuals, still a clear relationship couldn't be drawn due to different study limitations such as the lack of subdivision in the TMD patients based on their diagnostic subcategories in addition to, patients' posture might have been altered while the photo was captured. Ever since, multiple researchers deliberately investigated the two conditions association and inferred the following: 1. FHP can be a risk factor resulting in TMD where any alteration in the head position produces more tension on the masticatory muscles by changing the mandible position 2. TMD origins from muscular component is more significant than articular component yet the correlation between head posture and TMD is still not clear enough, however, if FHP and myogenic TMD were linked preventive measures can be taken. recently, multiple studies established a relation between the occurrence of FHP in TMD patients which supported the suspected relation between them but without a clear association. Till present, no study has investigated the additional effect of FHP DCTO correction impact on myogenic TMD, and this is where the purpose of this study arises from.

Eligibility Criteria:
Inclusion Criteria:

* The participant experiencing one or more of TMD signs or symptoms and has been diagnosed with TMD beside having forward head posture with craniocervical (CVA) angle \< 50.
* The study will be limited to the patients in the dental clinic of the university of Sharjah.
* Participants experiencing mild to moderate myogenic TMD with symptoms of orofacial pain and limited range of jaw opening.

Exclusion Criteria:

* Previous head, neck or TMJ traumas.
* History of temporomandibular joint surgery.
Deep-learning For Ultrasound Classification of Anterior Talofibular Ligament Injury

Ultrasound (US) is a more cost-effective, accessible, and available imaging technique to assess anterior talofibular ligament (ATFL) injuries compared with magnetic resonance imaging (MRI). However, challenges in using this technique and increasing demand on qualified musculoskeletal (MSK) radiologists delay the diagnosis. Using datasets from multiple clinical centers, the investigators aimed to develop and validate a deep convolutional network (DCNN) model that automates classification of ATFL injuries using US images with the goal of providing interpretable assistance to radiologists and facilitating a more accurate diagnosis of ATFL injuries.

The investigators collected US images of ATFL injuries which had arthroscopic surgery results as reference standard form 13 hospitals across China;Then the investigators divided the images into training dataset, internal validation dataset, and external validation dataset in a ratio of 8:1:1; the investigators chose an optimal DCNN model to test its diagnostic performance of the model, including the diagnostic accuracy, sensitivity, specificity, F1 score. At last, the investigators compared the diagnostic performance of the model with 12 radiologists at different levels of expertise.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years old
* patients who had experienced an first-episode, acute ankle sprain and received US examination within 14 days post injury
* patients who had a corresponding arthroscopic surgery result for classification of the ATFL injury.

Exclusion Criteria:

* patients who had a previous history of ankle open trauma or ankle joint surgery
* there were any soft-tissue or bone tumors in the ankle
* there was concurrent with any other rheumatoid arthritis
* the image quality was low or there were severe artifacts (eg, anisotropic artifacts)
Retrospective Observational Study on Prediction of Response to PD-1 Immunotherapy in Patients with NSCLC

Therapeutic antibodies that block the programmed death-ligand 1 (PD-L1)/programmed death-1 (PD-1) pathway have revolutionized immuno-oncology by inducing robust and durable responses in patients with various cancer including advanced non-small-cell lung cancer (NSCLC). However, these responses only occur in a subset of patients, even in case of PD-L1 overexpression. Elucidating the determinants of response and resistance but also of severe immune-mediated adverse events is key to improving outcomes and developing new treatment strategies. Biomarkers that predict immune checkpoint inhibitors efficacy and toxicity are urgently needed and could emerge from characterization of tumor microenvironment.

The purpose of PREDICTION project is to elucidate response and toxicity predictive immunophenotypic signatures using a new in situ multiplexed strategy with imaging mass cytometry Hyperion. Patients treated with anti-PD-1 pembrolizumab will be selected on their response and toxicity profiles. Then, tumor samples will be analysed with Hyperion technology, allowing delineation of cell subpopulations and cell-cell interactions, highlighting tumor heterogeneity and to determine correlations between response and toxicity features. The number of co-analysable markers enables global vision on the same tissue section. A better understanding of the tumor microenvironment complex system will lead to discover new predictive biomarkers potentially transferable to current practice.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Advanced NSCLC with PD-L1 TPS of 50% or greater
* Administration of first line pembrolizumab between January 2017 \& December 2019

Exclusion Criteria:

* Auto-immune disease
* Prior exposure to immunotherapy
* First dose pembrolizumab administered after December 2019
Comparison of Dentin Hypersensitivity Reduction Over a 1-month Period

Here we assessed the clinical effectiveness of Gluma, fluoride varnish, and the Tetric N-Bond one-step self-etch system in alleviating DH instantly and over 1 month, after a single topical application.A randomized, double-blind, clinical trial was conducted on 55 patients (25 males, 30 females; age: 20-49 years). Seventy teeth were randomly assigned to three groups: Gluma (n = 24); fluoride varnish (n = 23); and Tetric N-Bond adhesive (n = 23). Sensitivity to tactile, air blast, and cold stimuli were investigated.. A visual analogue scale was used to assess tactile stimuli, and the Schiff Cold Scale to assess air blast and cold stimuli. DH was evaluated immediately post-treatment, and at the 2-week and 1-month follow-up. Between-group and within-group comparisons were made.


Eligibility Criteria:
Inclusion Criteria:

* Middle-aged adult population who usually complains of Dentin Hypersensitivity.
* Age range 20-49 years, that visit the dental hospital at King Abdul-Aziz university (KAUDH) who would have at least one or two teeth with DH
* Those with recession of the gingiva, teeth erosion or abrasion.
* Patients agreed to participate in the study.

Exclusion Criteria:

* Patients going through professional desensitizing treatment during the previous three months; Using desensitizing tooth paste in the last two months
* Chronic; far on progress periodontal disease; treatment for periodontal disease;
* Teeth with ICDAS (International Caries Detection and Assessment System) score 4
* Teeth diagnosed for irreversible pulpitis; root canal treated teeth
* Teeth covered with crowns; bridge
* Teeth with cervical restorations interfering with the evaluation
* Medically compromised patients currently using medications like anticonvulsants, antihistamines, antidepressants, sedatives or daily analgesics.
* Pregnant or lactating women; were also excluded.