cyrilzakka/clinical-trials huggingface dataset:
Long-term Safety and Efficacy Study of Fitusiran in Patients With Hemophilia A or B, With or Without Inhibitory Antibodies to Factor VIII or IX

Primary Objective:

To characterize the long-term safety and tolerability of fitusiran

Secondary Objectives:

* To characterize the efficacy and long-term efficacy of fitusiran as assessed by the frequency of:

  * Bleeding episodes
  * Spontaneous bleeding episodes
  * Joint bleeding episodes
* To characterize the effects of fitusiran on health-related quality of life (HRQOL) measures in participants ≥17 years of age

The estimated total time on the study for a participant is up to 90 months (including screening, treatment period and safety follow up period).

Eligibility Criteria:
Inclusion criteria :

* Participant must be at least 12 years of age inclusive, at the time of signing the informed consent
* Participants with severe hemophilia A or B who have completed a Phase 3 fitusiran clinical trial
* Male
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol. In countries where legal age of majority is above 18 years, a specific ICF must also be signed by the participant's legally authorized representative

Exclusion criteria:

* Completion of a surgical procedure within 14 days prior to screening, or currently receiving additional factor concentrate or BPA infusion for postoperative hemostasis
* Current participation in immune tolerance induction treatment (ITI)
* Current use of factor concentrates or bypassing agents (BPAs) as regularly administered prophylaxis designed to prevent spontaneous bleeding episodes except for participants requiring factor concentrates or BPAs prophylaxis during the study dosing pause period
* Use of compounds other than factor concentrates or BPAs for hemophilia treatment
* Current or prior participation in a gene therapy trial
* Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) \>1.5 × upper limit of normal reference range (ULN) for patients who are naïve to fitusiran at study start; ALT and/or AST \> 5 x ULN for patients who were in the fitusiran arm in the parent study
* Additional exclusions for participants not currently participating in a fitusiran trial at the time of enrollment in the lower dose cohort:

  * Clinically significant liver disease
  * History of arterial or venous thromboembolism

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Prospective and Retrospective Cohort Study to Find New Prognostic Factors and Therapeutic Targets in Patients With Newly Diagnosed or Relapsed Malignant Hematologic Disorder Excluding Acute Leukemia

The purpose of this study is to elucidate the factors which are associated with the diagnosis and predict prognosis and therapeutic targets by collecting specimens of tissue sample, peripheral blood, and bone marrow aspirates at the time of diagnosis or relapse/refractory in patients with malignant hematologic disorders except acute leukemia. This study is eligible for patients who are diagnosed with malignant hematologic disorders except acute leukemia or who will have diagnostic procedure with suspicion of having hematologic malignancy. Prospective cohort is for patients who are not in treatment for hematologic malignancy. Retrospective cohort is for patients who are diagnosed and in treatment.


Eligibility Criteria:
Inclusion Criteria:

* The patients with malignant hematologic disorders except acute leukemia who are diagnosed pathologically according to the revised 2008 WHO classification of tumours of haematopoietic and lymphoid tissue or who will have diagnostic procedure with suspicion of having hematologic malignancy.
* Any gender and age ≥ 19 years
* Written informed consent
* Diagnosed after 2005-01-01 in retrospective cohort group.

Exclusion Criteria:

* Patients who cannot understand or disagree the informed consent
* Patients who diagnosed with acute leukemia
Multimodal Prehabilitation for Resectable Gastric Cancer

Surgical resection is the mainstay for gastric cancer. Surgical stress response, like insulin resistance and catabolism, is inevitable and is a risk factor for postoperative outcome. To cope with this stress, the enhanced recovery protocol has been proposed and successfully implemented in clinical practice. Recently, prehabilitation have attracted increasingly attention, which is the preoperative part of enhanced recovery pathway. Prehabtilitation are bundles of evidenced elements in order to improve patient's functional capacity. Patients with gastric cancer are usually suffered from nutritional risk, anxiety and frailty. In this trial, we investigate whether multimodal prehabilitation (exercise, nutrition and psychological support) could improve patient's functional status to better tolerate surgical trauma.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed gastric cancer, clinical I-III TNM stage (AJCC 8th edition);
* Will receive curative-intent surgery;
* Life expectance \> 6 months;

Exclusion Criteria:

* Gastric stump cancer or combined with other malignances;
* NYHA III, NYHA IV;
* Inability to swallow, with gastrostomy, or inability to move because of orthopedic disease or neuromuscular disease;
* Psychiatric disorders, COPD, end-stage hepatic or renal disease, uncontrolled cardiac arhythmia or uncontrolled hypertention;
* Receiving immunosuppressive therapy;
* Emergency surgery because of tumor bleeding or tumor perforation;
Different Glycemic Index (GI) Values in 7 Food Products

This study is initiated to investigate the glycemic index value of seven food products.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or non-pregnant females at least 6 weeks postpartum, non-lactating and aged 21-60yrs old in both groups.
* They should not suffer from any chronic diseases.
* no known food allergy or intolerance.
* no medications known to affect glucose tolerance(excluding oral contraceptives). Note: stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable.

Exclusion Criteria:

* Age less than 21 years old and greater than 60 years old.
* known history of diabetes mellitus or the use of antihyperglycemic drugs or insulin to treat diabetes and related conditions.
* known history of AIDS, hepatitis, renal or heart disease or any other serious complications that may interfere with glucose metabolism.
* subjects using any medication (eg steroids, protease inhibitors or antipsychotics, etc.) that would interfere with the digestion and nutrient absorption.,
* subjects having gastrointestinal diseases that may interfere with nutrient absorption, distribution, metabolism, excretion and have no known food allergies.
* a major medical or surgical event requiring hospitalisation within the preceding 3 months.
Cancer Genome Study Using Samples From Patients With Stage I or Stage II Non-Small Cell Lung Cancer Treated on Clinical Trial ACOSOG-Z0030

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at the cancer genome using tumor samples from patients with stage I or stage II non-small cell lung cancer treated on clinical trial ACOSOG-Z0030.

OBJECTIVES:

* To investigate the clinical relevance of conducting comprehensive molecular analyses on clinically annotated high-quality tumor biospecimens from patients with stage I or II, N0 or N1 (less than hilar) non-small cell lung cancer.

OUTLINE: This is a multicenter study.

Biological specimens are collected from participating clinical sites and analyzed by transcription profiling of RNA and microRNA; detection of DNA copy number changes and chromosomal rearrangements; epigenetic modifications analyses; and sequencing of genomic segments, genes, and regulatory regions to assess sequence variation. Clinical information associated with each specimen donor is also collected.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of non-small cell carcinoma

  * Primary, untreated disease
  * Stage I or II (T1 or T2, N0 or non-hilar N1, M0) disease
  * Any of the following histologies allowed:

    * Squamous cell carcinoma
    * Adenocarcinoma (\< 10%)
    * Large cell carcinoma (high-grade)
* Available tumor tissue samples collected on clinical trial ACOSOG-Z0030 and meeting the following criteria:

  * Snap-frozen and stored at a temperature of -80°C or lower
  * Specimens may come from any site within the lung or one that is involved by direct regional extension of tumor from the originating site in the lung
* No regional lymph node or distant metastases
* No recurrent or persistent disease after prior neoadjuvant or adjuvant treatment for lung cancer
* Must have matching frozen samples of normal tissue and blood
A Church Based Intervention to Improve Diabetes Care

The purpose of this study it to determine if a culturally appropriate, church based intervention for African Americans with type 2 diabetes, will lead to improved glycemic (blood sugar) control.

African Americans suffer disproportionately from diabetes and its complications. To reduce this burden of suffering, innovative interventions are needed to improve self-care behaviors including: dietary intake, physical activity (PA), self-monitoring, and medication adherence. The goal of this study (A New DAWN) was to develop and test a culturally appropriate, church-based intervention to improve diabetes self-management and glycemic control.

Twenty-four African American churches in central NC were recruited and randomized to receive the special intervention (SI-13 churches, 117 participants) or the delayed intervention (DI-11 churches, 84 participants). The SI included an 8-month intensive phase consisting of: 1 individual dietary assessment and counseling visit; 12 group sessions; monthly phone contact with a peer counselor (church diabetes advisor (CDA)); and 3 printed encouragement messages from the primary care clinician. This was followed by a 4-month reinforcement phase including monthly phone contacts from the CDA. At 8- and 12-month follow-up, HbA1c was assessed by high-performance liquid chromatography.

At baseline, 64% of participants were female and means were: age 59, years with diabetes 9, HbA1c 7.8%, Systolic Blood Pressure 139, Diastolic Blood Pressure 76, and BMI 35.0. A total of 174 (87%) participants returned for 8-month measures. Adjusting for baseline values and randomization by church, the mean HbA1c level was 7.4% for the SI and 7.8% for the DI (difference 0.4%, 95% Confidence Interval (CI) 0.1-0.6, p = 0.009). There were no statistically significant differences between groups for BP or BMI. Of 82 (70%) SI participants completing an 8-month follow-up questionnaire, 65 (79%) were very satisfied with the nutritional component, 63 (77%) were very satisfied with the PA component, and 72 (88%) considered the program to be very helpful overall.

In A New DAWN, the SI was acceptable and produced a modest, but clinically significant, reduction in HbA1c. These findings support the acceptability and effectiveness of self-management interventions given in a church setting for African Americans with type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* age 20 or older
* diagnosis of type 2 diabetes (diagnosis at age 20 or greater and no history of ketoacidosis)
* clinical care provided by primary care clinician
* plans to reside within 50 miles of church for 1 year
* has home phone or easy access to one

Exclusion Criteria:

* diabetes secondary to another condition
* pregnancy/lactation
* inability to speak English
Text Message Safety Behavior Fading for Appearance Concerns

The current study aims to explore the efficacy of a text message based safety behavior fadinig intervention compared to an unhealthy behavior fading intervention for appearance concerns.

Description: Appearance-related safety behavior fading intervention procedures will follow methodology previously used in the Cougle Lab. The safety behavior fading intervention is designed to target a decrease or elimination of appearance-related safety behaviors.

Individuals randomly assigned to the safety behavior fading condition will receive instructions to decrease or eliminate their endorsed appearance-related safety behaviors. In addition, they will receive daily reminders via text message to decrease these behaviors, along with a safety behavior monitoring checklist in which the participant indicates the extent to which they decreased and/or eliminated each safety behavior over the previous day.

Individuals randomly assigned to the unhealthy behavior fading condition will receive instructions to decrease or eliminate unhealthy behaviors. They will also receive daily reminders via text message to decrease these behaviors, along with a safety behavior monitoring checklist in which the participant indicates the extent to which they decreased and/or eliminated each safety behavior over the previous day.

Eligibility Criteria:
Inclusion Criteria:

* elevated appearance concerns as defined by a score of 53 or higher on the SAAS
* Being female

Exclusion Criteria:

* being male
* Score of 52 or lower on the SAAS
* Currently receiving treatment (therapy, counseling, etc.) for anxiety, depression, eating disorder, or body image/appearance concerns
* If applicable, unstable psychiatric medication usage any time over the past 4 weeks
Platelet Rich Plasma for Carpal Tunnel Syndrome

Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with involving compression of the median nerve in the carpal tunnel. Although many conservative managements of CTS, the effectiveness of these methods is insignificant or only persist for a short duration. The platelet rich plasma (PRP) is a new and potential treatment for patients with kinds of musculoskeletal disorders and recent reports showed being beneficial for peripheral neuropathy in animal studies. Since 2014, four small clinical trials showed the positive effect of PRP in peripheral neuropathy. Among these studies, two small trials showed beneficial effect of PRP for patients with mild CTS. However, the definite clinical effect of PRP for peripheral neuropathy from currently published studies is unclarified because these studies enrolled a few patients and lacked long-term follow-up (no more than 6 months follow-up).

After obtaining written informed consent, patients of clinically diagnosed with bilateral CTS were randomized into intervention and control side. Intervention group received one-dose ultrasound-guided PRP injection and control group received one-dose ultrasound-guided normal saline injection. No additional treatment after injection through the study period. The primary outcome is Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and secondary outcomes include visual analog scale (VAS), cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of the median nerve, and finger pinch strength. The evaluation was performed pretreatment as well as on the 2nd week, 1st, 3rd, 6th month and one year after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20-80 year-old.
* Diagnosis was confirmed using an electrophysiological study

Exclusion Criteria:

* Cancer
* Coagulopathy
* Pregnancy
* Inflammation status
* Polyneuropathy, brachial plexopathy
* Thoracic outlet syndrome
* Previously undergone wrist surgery or steroid injection for CTS
Growth Evaluation, Health Promotion, and Clinical Management in Children and Adolescents With Thalassemia

There are nearly 300,000 patients with severe or intermediate thalassemia in China. Growth retardation is the most significant health issue for children and adolescents with transfusion-dependent thalassemia (TDT), placing a substantial economic burden on their families and a serious social strain on the labor force. Investigating the growth and development of these children and adolescents, and establishing targeted intervention plans, holds significant social value for public health practice.

1. To screen and identify pediatric patients with growth problems by conducting growth and development assessments in high-incidence areas of China, including physical development, endocrine function, nutritional status, brain function and lifestyle behaviors.
2. Implement the MENBS clinical interventions for pediatric patients with growth problems, concentrating on the following areas:

   * Monitor: Continuously monitor health-related indicators through regular follow-up.
   * Education: Provide health education to improve the cognition of patients and their families.
   * Nutrition: Assess patients' nutritional risks and develop personalized diet plans.
   * Behavior: Recommend appropriate exercise plans to promote physical development.
   * Support: Conduct home visits, offer free clinics and establish a support network.
3. Repeat growth assessment for pediatric patients with growth problems after 1-year clinical interventions.
4. Evaluate the effectiveness of MENBS interventions by comparing changes in growth and development indicators.


Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed with transfusion-dependent thalassemia (TDT)
* Male or female age ≤18 years
* Subjects who are willing and able to provide written informed consent

Exclusion Criteria:

* Not applicable
Comparison of Cardiac Resynchronisation Therapy (CRT) Response Using High Frequency (HF) - ECG or Q-LV Guided Optimisation for Left Ventricular, Pacing Site.

The research aims to compare the response of Cardiac Resynchronisation Therapy (CRT) using HF ECG guided or the conventional method of Q-LV measurement guided optimisation for left ventricular, pacing site.

The study aims to demonstrate that left ventricular (LV) pacing site optimisation using high frequency (HF) ECG improves LV reverse remodeling response to Cardiac Resynchronization Therapy (CRT), compared with Q-LV (Q-wave on the surface ECG to LV Electrogram) measurement after 6 months of treatment.

Participants will be implanted with a Cardiac Resynchronisation Therapy device with either pacemaker or defibrillator function.

The study is a single-Centre, randomized, prospective trial. One hundred and eighty participants will be assigned to either the treatment (HF-ECG guided LV pacing site optimisation) or control (Q-LV guided LV pacing site optimisation) arm, employing a 1:1 randomization. The participants will be followed up for a period of 6 months.

Eligibility Criteria:
Inclusion Criteria:

* • Eligible for implantation of a CRT-D device according to published relevant ESC and CCS guidelines;

  * In sinus rhythm;
  * NYHA class II, III or IV
  * Have reviewed, signed and dated an informed consent.
  * Age 18

Exclusion Criteria:

* Previous implant with a pacemaker, an ICD or a CRT device. (except upgrade from single chamber ICD with a fully functional defibrillation lead) not under recall or surveillance);
* Persistent atrial arrhythmias (or cardioversion for atrial fibrillation) within the past month;
* Ventricular tachyarrhythmia of transient or reversible causes such as acute myocardial infarction (MI), digitalis intoxication, drowning, electrocution, electrolyte imbalance, hypoxia or sepsis, uncorrected at the time of the enrolment;
* Incessant ventricular tachyarrhythmia;
* Unstable angina, or acute MI, Coronary Artery Bypass-Grafting (CABG), or Percutaneous Coronary Intervention (PCI) within the past 4 weeks;
* Correctable valvular disease that is the primary cause of heart failure;
* Indication for valve repair or replacement;
* Recent Cerebro-Vascular Accident (CVA) or Transient Ischemic Attack (TIA) (within the previous 3 months);
* On transplant waiting list;
* Previous heart transplant;
* Already included in another clinical study that could confound the results of this study;
* Life expectancy less than 1 year;
* Inability to understand the purpose of the study;
* Unavailability for scheduled follow-up or refusal to cooperate;
* Age of less than 18 years;
* Pregnancy;
* Drug addiction or abuse;
* Under guardianship.
Genetic Sources of Variability of the Adaptation of the Ventricular Repolarisation

The main objective is to research for genetic factors involved in the extreme modifications of the QT interval of the electrocardiogram in answer to a pharmacological stimulation (sotalol) and physiological stimulation in the apparently normal general population.

The phenotypic characterization, based on the ventricular repolarisation dynamics will be used aiming at term of the predictive genetic factors of the acquired long QT syndrome

Study of 1000 apparently healthy subjects which will receive an unique dose of Sotalol and will have an effort test on ergonomic bicycle, an auditive stimulation and a taking of DNA.

Eligibility Criteria:
Inclusion Criteria:

* Both sexes
* Age between 18 and 60 years
* European or North African Origin
* Body mass index between 19 and 29 kg / m ²
* Obtaining informed and written consent

Exclusion Criteria:

* Asthma
* Heart rate \< 50 bpm
* Systolic blood pressure \< 100 mm Hg
* Atrioventricular block
* Known chronic illness with chronic treatment
* Raynaud phenomenon
* QT prolonging drug
* Family or personal history of the congenital long QT syndrome
* QT/QTc Fridericia (QTcf) \> 450 ms
* Pregnancy
Beta-glucan and Immune Response to Influenza Vaccine

This trial in healthy adults will determine the effects of beta-glucan, a dietary fiber supplement isolated from baker's yeast, on immune response to the influenza vaccine.

Beta-glucans have been shown to enhance the innate and adaptive immune responses in cell cultures, animal models, and humans, thus adults over the age of 50 years receiving the influenza vaccination may benefit in terms of their immune response from supplementation with beta-glucans. This is a 6-week randomized, double-blind, placebo-controlled, 2-arm parallel study designed to evaluate the adjuvant effect of beta-glucan dietary supplementation during influenza vaccination. Participants will consume either the beta-glucan or placebo capsules for 42 days. Participants will complete an online Qualtrics daily questionnaire of compliance, fatigue, and cold and flu symptoms throughout the 42-day study. Influenza vaccine will be administered on or about day 14. The Gastrointestinal Symptom Rating Scale (GSRS) and the Mood and Feelings Questionnaire (MFQ) will be completed at baseline, 2 weeks and 6 weeks. Blood draws for antibody and cytokine response will be completed at baseline, and on or about days 14 and 15, and on day 42.

Eligibility Criteria:
Inclusion Criteria:

1. Adult volunteers ≥ 50 years of age.
2. Planning to be vaccinated for influenza
3. Have been immunized for COVID-19
4. Willing and able to provide written informed consent in English.
5. Willing and able to comply with all the study-related procedures, including attending to study visits for blood draw, taking the influenza vaccine, intake of the study supplement, and completing study questionnaires.

Exclusion Criteria:

1. Demonstrate an inability to comply with the study-related procedures.
2. Have a history of a severe reaction or hypersensitivity following vaccination with influenza vaccine, vaccination with any other vaccine containing the same substances, or intake of the study product.
3. Have an immune system alteration because of an underlying illness (e.g., autoimmune disease) or immune-suppressing treatment (e.g., steroids (last 30 days); cytotoxic drugs, medical surgery, or radiation therapy during the 6 months, previous to enrollment).
4. Be concurrently participating in a clinical trial that, in the judgement of the investigator, would interfere with the evaluation of the study outcomes.