cyrilzakka/clinical-trials huggingface dataset:
Pulmonary Hypertension SOLAR

The main goal of this study is to develop a noninvasive signature for pulmonary vascular remodeling in Group 3 PH patients, using hyperpolarized 129Xe magnetic resonance imaging (129Xe MRI). Such a signature may identify Group 3 PH responders to PAH-specific therapies. PAH's unique 129Xe MRI signature has been shown in previous studies. Past studies have lacked a pathologic "ground truth" correlate of these signatures, which could be provided by comparing them with the pathology of lung explant tissue from patients who have undergone a lung transplant. This signature could be validated in a cohort of patients with Group 3 PH in future studies.

The objective of this study is to identify a 129Xe MRI signature associated with PAH-like pulmonary vascular remodeling, consisting of plexiform arteriopathy, smooth muscle cell proliferation, and vascular fibrosis, in IPF and COPD that could be used to identify potential responders vs non-responders to PAH-specific therapies. The central hypothesis is that similar mechanisms and pathways underlie pulmonary vascular remodeling in IPF-PH, COPD-PH, and PAH. However, only a subset of Group 3 PH patients display remodeling consistent with PAH, resulting in responder vs. non-responder phenotypes when treated with PAH-specific therapies. In preliminary studies of subjects treated with Tyvaso, The study team has observed distinct 129Xe MRI signatures at baseline and with therapy depending on patients' underlying lung function. Consistent with this, recent studies using single-cell RNA sequencing (scRNAseq) of the pulmonary vasculature in IPF have demonstrated changes consistent with vascular remodeling.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years' old
2. Be on the lung transplant waiting list at Duke University Medical Center.
3. PH as defined by RHC - mPAP \> 20 mmHg, PVR \> 3 WU, PCWP \< 15 mmHg
4. Groups defined as:

   PAH: Clinical diagnosis of PAH (Group 1 PH) in the absence of severe chronic lung disease, left heart disease, chronic thromboembolism, sarcoidosis, sickle cell disease, or other causes of non-Group 1 PH.

   COPD-noPH: Clinical diagnosis of COPD in the absence of precapillary PH.

   COPD-PH: Clinical diagnosis of COPD with precapillary PH.

   IPF-noPH: Clinical diagnosis of IPF in the absence of precapillary PH.

   IPF-PH: Clinical diagnosis of IPF with precapillary PH.
5. Willing and able to give informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed).

Exclusion Criteria:

1. Moderate to severe heart disease (LVEF \< 45% or severe LV Hypertrophy).
2. Sarcoidosis.
3. Active cancer.
4. Sickle cell anemia.
5. Liver disease (Childs-Pugh class C).
6. Prisoners and pregnant women will not be approached for the study.
7. Inability to obtain consent.
8. Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine).
9. Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements
3K3A-APC for Treatment of Amyotrophic Lateral Sclerosis (ALS)

Phase 2 open label trial to investigate the safety and potentially efficacy of 3K3A-APC in patients with Amyotrophic Lateral Sclerosis (ALS).

This Phase 2 open label trial seeks to investigate whether a novel therapy named 3K3A-APC is safe and potentially effective in patients with Amyotrophic Lateral Sclerosis (ALS). A total of 16 patients with ALS will be enrolled into 2 dose cohorts with five doses of 15mg or 30mg doses given 12 hours apart in each cohort. The primary study outcomes are to ensure the safety and tolerability of 3K3AAPC in ALS patients, and to determine whether 3K3A-APC is able to reduce the pathological changes that might possibly cause ALS.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have clinically definite ALS (Awaji Criteria)
2. Male or female age 18 years and less than 75 years at time of ALS study
3. Symptom onset less than 36 months before screening
4. Diagnosis of ALS less than 24 months before screening
5. Clinically definite Upper Motor Neuron signs

Exclusion Criteria:

1. Current treatment with anticoagulants (e.g., warfarin, novel oral anticoagulants, heparin) that might preclude safe completion of the lumbar puncture
2. Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia
3. Use of investigational drugs or devices within 60 days prior to Baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10)
4. Prolonged prothrombin time or activated partial thromboplastin time \>2xULN
5. Severe hypertension or hypotension
6. Glomerular filtration rate (GFR) \<35 mL/min
7. Forced vital capacity (FVC) at screening of \<50% of predicted
8. Prior exposure to any exogenous form of APC
9. Inability to lie flat for procedures (MRI, PET, LP)
10. Pregnant or lactating during the study period
BCMA CAR-T for Dynamic High-risk Multiple Myeloma

This is a single-arm, open-label study to evaluate the efficacy and safety of BCMA CAR-T in dynamic high-risk patients with multiple myeloma

The study is a prospective, single-arm, single-centre, phase II study designed to evaluate the efficacy and safety of BCMA CAR-T in dynamic high-risk patients with multiple myeloma. Patients received BCMA CAR-T cells infusion after standard FC lymphoma deletion therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Be informed and voluntarily sign the Informed Consent Form (ICF).
2. Age between 18 and 75 years (inclusive).
3. Have measurable disease meeting at least one of the following criteria: Serum M-protein ≥1 g/dL (\>10 g/L) as detected by serum protein electrophoresis (SPEP), or quantifiable IgA or IgD levels for IgA or IgD-type myeloma; Urine M-protein ≥200 mg/24 hours; In cases where serum and urine M-protein do not meet the above thresholds, an abnormal free light chain (FLC) ratio (normal range: 0.26 to 1.65) and involved serum FLC ≥100 mg/L.
4. Have received only one line of standard anti-myeloma therapy, including: Induction therapy with at least one proteasome inhibitor, one immunomodulatory agent, and corticosteroids; Sequential autologous hematopoietic stem cell transplantation or consolidation therapy; Maintenance therapy based on either a proteasome inhibitor or an immunomodulatory agent.
5. Meet at least one of the following dynamic high-risk criteria: Early relapse: Disease progression or relapse within 18 months of starting first-line therapy, including progression or relapse within 12 months post-autologous hematopoietic stem cell transplantation; Primary refractory disease: Failure to achieve at least minimal response (MR) after four cycles of induction therapy; Relapse with new genetic abnormalities: Gain(1q), del(17p), or TP53 mutation.
6. Confirmed expression of the BCMA target antigen on MM cells by flow cytometry or bone marrow immunohistochemistry.

Exclusion Criteria:

1. Primary plasma cell leukemia.
2. Concurrent amyloidosis.
3. Involvement of the central nervous system (CNS).
4. Previous treatment with BCMA-targeted therapy or CAR-T cell therapy.
5. Disease progression or relapse within 3 months of autologous hematopoietic stem cell transplantation.
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Austria

This is a National, Multicentre, Observational Registry to study adherence and long term outcomes of therapy in paediatric subjects using Easypod™ electromechanical device for growth hormone treatment from hospitals in Austria and to assess the level of adherence of subjects receiving SAIZEN® via Easypod™.

Subjects will be enrolled in a multicenter, longitudinal observational registry. Parents/subjects will provide their Informed Consent/assent to upload their data for populationbased analyses and optionally to adhere to a patient adherence support program designed to improve their adherence and, ultimately, clinical outcomes. Adherence data will be primarily derived from the Easypod™ device combined with physician data entry of outcome measures. Data will be collected retrospectively and prospectively. This will allow the establishment of adherence profiles and explore the hypothesis that patient adherence support programs improve adherence and subsequent clinical outcomes. Collected data will be also analyzed in a multinational pooled analysis of comparable national studies.

Primary Objective:

- To assess the level of adherence of subjects receiving SAIZEN® via Easypod™

Secondary Objectives:

* To identify adherence subject profiling
* To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN® via Easypod™
* To asses the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (i.e. above, below or within normal ranges)

Eligibility Criteria:
Inclusion Criteria:

* Administered growth hormone via the Easypod™ electromechanical device according to the Austrian Summary of Product Characteristics (SmPC)
* Over the age of \>2 years
* Under \<18 years of age, or over 18 without fusion of growth plates
* Parent's or guardian's written informed consent, given before entering data into the registry, with the understanding that the subject or parent/guardian may withdraw consent at any time without prejudice to future medical care. If the child is old enough to read and write, a separate assent form will be given as defined in the appropriate jurisdiction of each country.

Exclusion Criteria:

* Subjects taking growth hormone in whom growth plates have fused (i.e. for taking growth hormone for it's metabolic effects)
* Contra-indications to SAIZEN® as defined in the SmPC
* Use of an investigational drug or participation in another interventional clinical study
Study of Calcium Plus Vitamin D Supplementation in Prevention of Colorectal Adenomas Recurrence

Calcium plus vitamin D may be effective in the prevention of colorectal adenoma recurrence. The aim of this study is to investigate the effect of supplementation with calcium plus vitamin D on the recurrence of colorectal adenomas.

Colorectal adenomas are well-known to be precancerous lesions that develop into colorectal cancers on the basis of the adenoma-carcinoma sequence. The effects of screening for colorectal adenomas and removing precancerous lesions on the prevention of colorectal cancer have been established. Because of the high recurrence rates of colorectal adenomas in patients who have undergone polypectomy, the potential chemopreventive agents that may reduce the risk of colorectal adenoma recurrence need to be investigated. Since laboratory and epidemiologic evidence suggests that calcium or vitamin D may help prevent colorectal adenomas, we conduct a randomized, placebo-controlled, prospective clinical trial to study the effect and safety of calcium plus vitamin D supplementation in prevention of colorectal adenomas recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18-65years
* Individuals who had at least one histologically confirmed colorectal adenoma removed within three months before recruitment
* Individuals without a history of familial polyposis
* Those who voluntarily sign the consent form after being fully informed and understanding the purpose and procedures of the study , characters of the disease, effect of medications, methods of related examinations, and potential risk/benefits of the study

Exclusion Criteria:

* Patients who are hypersensitive or intolerant to the drugs
* Patients who are intolerant to another colonoscopy examination
* Patients with hypercalcemia or urolithiasis
* Pregnant women, women during breast-feeding period, or women with expect pregnancy
* Patients with diabetes mellitus, severe heart or renal disease, or cancer history
* Patients with a history of subtotal gastrectomy or partial bowel resection
* Patients who are not able to cooperate
* Individual who are involved in designing, planning or performing this clinical trial
* Patients with medical conditions who are not appropriate to participate the study
* Patients who are taking aspirin, NSAIDs or COX2 inhibitors
* Patients who are taking folic acid or Butyrate.
* Patients with IBD
The Effect of Laughter Therapy in Women

Migraine: An episodic disorder consisting of severe headache, usually with photophobia (sensitivity to light), phonophobia (sensitivity to sound), and/or nausea (occasionally vomiting). Migraine is predominantly a female disease. The incidence of migraine was found to in women (18.2/1000 person-years) and between the ages of 15-19 in men (6.2/1000 person-years). The incidence of migraine was found to peak between the ages of 20-24 in women (18.2/1000 person-years) and between the ages of 15-19 in men (6.2/1000 person-years). Migraine treatments are generally classified as pharmacological (treatment with medication) and non-pharmacological (treatment with no medication). Laughter therapy has recently come to the fore as a non-pharmacological and alternative treatment in chronic pain management. In a randomized controlled study, 30 minutes of laughter therapy was applied to women on the 2nd and 6th days after mastectomy surgery and it was determined that women who received laughter therapy had a significant decrease in pain and anxiety levels. This study was planned to determine the effect of laughter therapy on women with migraine.

The research will be carried out with young girls who are studying at the Faculty of Health Sciences of Sinop University in the 2022-2023 academic spring semester. Inclusion criteria for the research: Faculty of Health Sciences, to study in the 2022-2023 academic spring semester, to have been diagnosed with migraine, to be young girls and to volunteer to participate in the research. Exclusion criteria from the study; Not studying at the Faculty of Health Sciences and not volunteering to participate in the research. The application and control group will be determined on random.org among the group that constitutes the sample of the study. Laughter therapy sessions will be applied online for 25-30 minutes once a week for 2 months by the researcher who has the Laughter therapy certificate to the application group. At the end of two months, the Personal Information Form and Psychological Well-Being Scale will be administered again to both the application group and the control group.

Eligibility Criteria:
Inclusion Criteria:

* Being a nursing student,
* Being a female student,
* Volunteering to participate in the study.
* Being a woman
* Being diagnosed with migraine

Exclusion Criteria:

* Not to study as a nursing student

  * Being a male student
  * Not to volunteer to participate in the study
  * Not being a woman between the ages of 18 and 30
Evaluation of Meningococcal C Vaccine Programmes in Canadian Children

The purpose of the study is to see which of the three current provincial Meningococcal C Conjugate vaccine schedules in Canada provide the longest lasting protection against Meningococcal C disease and to see if a booster vaccination is needed.

In 2002-2005, Canada introduced universal MenC programmes consisting of 1,2 or 3 infant doses. Most are one (12 mth) dose. High rates of serogroupC disease in 2000 and 2001 prompted some provinces to launch universal MenC vaccination programmes in 2002. The goal was to provide protection in infancy and early childhood (the time of most risk) with the hope that the protection would extend throughout adolescence (the second highest risk). It is unclear if early multi-dosing or 1 dose programmes would offer better protection (lack of data). Each province in Canada has chosen different Meningococcal C Conjugate vaccine provision schedules for the primary vaccinations.

This study will look at short term protection after the differing provincial series of vaccinations has been given and compare those who do not get primary vaccination under 1 year of age (NS) with two schedules of primary immunization (BC at 2 and 4 mths and Alberta at 2 months). A blood sample will be collected at 12-13 mths for this comparison. A booster vaccination of the current provincial Men C vaccine will be provided at 12 months. Another blood sample will be collected 1 mth later to look at the difference in responses between the groups (different provincial primary vaccination schedule). 2 years and 4 years later (at age 3 and age 5), another blood sample will be collected to look at the difference in long term protection of the groups where the primary schedule was different.

Eligibility Criteria:
Inclusion Criteria:

* 12-13 mths of age
* over 34 weeks gestation
* healthy children
* having had all vaccinations of Meningococcal C vaccine per the recommended schedule for their respective province within a month of the recommended age - documented.
* Communication in English

Exclusion Criteria:

* No contraindication to receiving 12 mth dose of MenC vaccine
* No other MenC vaccine or MenC disease
Mindfulness and Yoga Training for Athletes With Concussion (MYTAC)

The purpose of this study is to establish the tolerability of mindfulness and yoga therapy in the post-concussion period.

Athletes and patients aged 15 - 60 will receive standard sports concussion evaluations at the Duke Sports Science Institute (SSI) and will learn about the study by the primary clinicians evaluating sports concussion at the SSI. Subjects will receive yoga training either at their home or at the Center for Living Campus at Duke. Subjects will complete their yoga assignments for 5 consecutive days, along with a symptom checklist. On the 6th day, subjects will complete the symptom checklist and mail all checklists to the study team in a stamped envelope. We expect to enroll 20 subjects.

If a subject has significant worsening of their symptoms and wishes to discontinue the study, they are requested to contact the study PI, Joel Morgenlander, MD. At that time, Dr. Morgenlander will document the specific reasons for discontinuation of the protocol. All follow-up care for their concussion will be through the provider they are already seeing for concussion. There is no significant risk to the athlete for participation except possible transient increase in their concussion symptoms. Benefits include possible hastening of recovery from their concussive symptoms and receiving training in mindfulness and yoga from a certified yoga instructor.

Eligibility Criteria:
Inclusion Criteria:

* Injury sustained within 30 days of enrollment
* Being seen for concussion at the Sports Science Institute (SSI) at Duke University Medical Center
* living in a 30 mile radius of the SSI
* SCAT5 (Sport Concussion Assessment Tool 5) modified symptom checklist score of greater than 12
Cetuximab+mFOLFOX6 VS. mFOLFOX6 Alone in RAS/BRAF Wild Type Patients With High-Risk Resectable CRLM

For patients with initially resectable colorectal cancer liver metastases who have high-risk factors, neoadjuvant therapy is currently considered a consensus approach. However, there is ongoing debate regarding the optimal treatment strategy. Our study aims to investigate whether the addition of cetuximab to neoadjuvant chemotherapy improves outcomes compared to neoadjuvant chemotherapy alone. The objective of this phase III clinical trial is to determine whether the combination of cetuximab and mFOLFOX6 chemotherapy is superior to neoadjuvant mFOLFOX6 chemotherapy alone for patients with initially resectable colorectal cancer liver metastases who have wild-type RAS/BRAF and high-risk factors.

Primary

• To determine whether the addition of cetuximab to neoadjuvant mFOLFOX6 chemotherapy results in improved event-free survival when compared with neoadjuvant mFOLFOX6 chemotherapy alone in patients with high-risk \& RAS/BRAF-wild-type \& resectable colorectal liver metastases.

Secondary

* To evaluate the overall survival of patients treated with these regimens.
* To evaluate the quality of life of patients treated with these regimens.
* To evaluate the preoperative remission rate, safety, surgical complications, actual resection rate, pathological resection status of patients treated with these regimens.

Eligibility Criteria:
Inclusion Criteria:

1. Histological proof of colorectal adenocarcinoma;
2. Age ≥ 18 years and ≤75 years;
3. RAS wild type；
4. CRS≥3；
5. Simultaneous liver-limited metastases;
6. At least one measurable liver metastases;
7. World Health Organization (WHO) performance status 0-1;
8. Life expectancy ≥ 3 months;
9. Adequate hematologic function: absolute neutrophil count (ANC)≥1.5×109/l, platelets≥100×109/l, and hemoglobin(HB) ≥ 9g/dl;
10. Adequate liver and renal function: total bilirubin ≤2.0 mg/dl, serum transaminases ≤ 5x upper limit of normal(ULN), and serum creatinine ≤ 1.5x ULN and creatinine clearance ≥ 30 ml/min;
11. Written informed consent.

Exclusion Criteria:

1. Previous systemic treatment for metastatic disease;
2. Previous surgery for metastatic disease;
3. Extrahepatic metastases;
4. Unresectable primary tumor;
5. Major cardiovascular events (myocardial infarction, severe/unstable angina, congestive heart failure, CVA) within 12 months before randomisation;
6. Acute or subacute intestinal obstruction;
7. Second primary malignancy within the past 5 years;
8. Drug or alcohol abuse;
9. No legal capacity or limited legal capacity;
10. Pregnant or lactating women;
11. Uncontrolled hypertension, or unsatisfactory blood pressure control with ≥3 antihypertensive drugs;
12. Peripheral neuropathy;
Characterizing Breast Cancer With 68Ga-FAPI PET/CT (PFB-01)

Fibroblast activation protein (FAP) is overexpressed in cancer-associated fibroblasts (CAFs), which constitute a major proportion of cells within the tumor microenvironment, especially in breast cancer. 68Ga-FAPI has been developed as a tumor-targeting agent. This prospective study is going to investigate the performance and value of 68Ga-FAPI PET/CT in patients with breast cancer.

Breast cancer is a complex, heterogeneous disease comprising numerous distinct biological subtypes characterized by variant pathobiological features and clinical behaviors. 18F-fluorodeoxyglucose (18F-FDG) PET/CT, an essential imaging modality in the characterization of metabolism within the tumor, has successfully evolved in the diagnosis, staging, and assessment of treatment response in patients with breast cancer. Cancer-associated fibroblasts (CAFs) are a crucial component of the tumor stroma with diverse functions. Fibroblast activation protein (FAP), a type II membrane-bound glycoprotein from the dipeptidyl peptidase-4 family, is highly expressed in the CAFs of several epithelial carcinomas, including breast cancer, coupled with relatively low expression in normal tissue. Gallium-68 (68Ga)-conjugated FAP inhibitor (FAPI), a new radiotracer targeting FAP, has been developed for targeting FAP and tumor-stromal visualization. With its fast renal clearance and high tumor-to-background ratio, 68Ga-FAPI has been successfully validated in multi-types of tumors. This study aims to evaluate the performance and value of 68Ga- FAPI PET/CT in patients with breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* age 18-80 years old;
* newly diagnosed BC confirmed by biopsy or with BI-RADS category 4C or 5 lesions by US or MG;
* BC clinical stagecT1-3 cN0-3 M0;
* no prior treatment for BC.

Exclusion Criteria:

* pregnancy;
* breastfeeding;
* patients who were unwilling to undergo PET/CT scans.