cyrilzakka/clinical-trials huggingface dataset:
Development and Clinical Validation of Early-stage Lung Cancer Prognostic Kit

Lung cancer is the leading cause of cancer mortality worldwide in spite of the advanced progresses in medication and low-dose CT screening. The early-stage lung cancer accounts for less than 50% of newly diagnosed lung cancer in Taiwan, even in stage IB patients proximately 30% still suffer from recurrence and metastasis.

The International Cancer Moonshot Project recently established the first comprehensive proteogenomics profiling of early-stage lung cancer patients in East Asia, revealing a proteomics-informed classification to identify a new "late like" subtype, which can identify a subgroup of early-stage patients with worse clinicopathological features (Cell, Cover story, 2020). This study has been featured in prestigious journals (Nat Rev Clin Oncol; Cancer Discov, 2020) and led to two provisional US patents. In this proposal, taking the discovery from the Cancer Moonshot multiomics database, the investigators aim to translate these findings into clinical utilities. Two subprojects are proposed. (1) Validation of "late-like" protein markers for identifying high-risk early-stage lung cancer: Two IVD kits will be developed, including high-risk early-stage lung cancer IHC prediction kit for tumor staining and high-risk early lung cancer ELISA prediction kit for noninvasive diagnosis. (2) Conducting a prospective clinical trial to evaluate the accuracy of high-risk early-stage lung cancer IHC prediction kit and high-risk early-stage lung cancer ELISA prediction kit.


Eligibility Criteria:
Inclusion Criteria:

* Willing to sign and provide subject consent.
* Male or female of age 20 or older.
* Patients diagnosed with lung adenocarcinoma by tumor pathology.
* Lung cancer with the pathological stage of IA/IB/II/IIIA according to the American Joint Committee on Cancer Staging Manual (8th Edition).
* Complete tumor resection (R0 resection).
* The East Coast Cancer Clinical Research Collaborative (ECOG) performance status was 0 or 1 at the time of grouping.
* Those willing to provide tumor tissue or cytology specimens (including surgical specimens, tissue biopsy specimens, or cytology specimens), blood and body fluid specimens (for follow-up or disease recurrence, such as urine, malignant pleural effusion, ascites, pericardial fluid, etc.).

Exclusion Criteria:

* Not primary lung cancer patients.
* Lung cancer patients whose pathological stage is not IA/IB/II/IIIA according to the American Joint Committee on Cancer Staging Manual (8th Edition) after surgery.
* Patients with uncontrolled malignant tumors other than lung cancer.
* Uncontrolled systemic disease (such as diabetes, hypertension, active infection, etc.) (determined by the principal investigator )
* Pregnant women.
* Any condition may put the patient at serious risk, may affect the interpretation of the trial results, or may seriously interfere with the patient's participation in the trial.
Exploring the Effects of Social Media Use and Environmental Factors

In this protocol, the investigators propose a randomised controlled trail to explore the effects of environmental factors and the use of technology on eating behaviours. The investigators have planned two studies to investigate these effects, one on high school students from Raffles Institution, and the other on the university population in the National University of Singapore.

Participants will be told a cover story that the study explores technological distraction on taste, and asked to complete a taste-evaluation taste of common snacks. One group (intervention group) will be asked to use their personal smartphones to engage in their pre-existing Whatsapp chats while doing the taste test. For the two control conditions, one group will be tasked with reading a neutral article on their personal smartphones while they complete the taste test, while the other group will be asked to complete the taste test without any use of smartphones.

Eligibility Criteria:
Inclusion Criteria:

* Normal weight: Body mass index of 18 to 25
* Have at least occasional breakfast meals (≥ 3 times a week of self-reported consumption of a breakfast meal)

Exclusion Criteria:

* Symptoms / history of any medical or psychiatric conditions
* Allergies to food products
* History of eating disorders
* Excessive exercise (≥ 5 times a week of self-reported exercise)
* Currently on a special diet or deliberating restricting caloric intake
* Currently on a weight loss program
* Smoking or substance abuse
NeVa ONE Registry Study

A prospective, open label study designed to assess the safety, performance and efficacy of thrombus removal in subjects presenting with acute ischemic stroke with the NeVa stent retrievers.

This is a prospective, open label, multi-center registry designed to assess the safety, performance and efficacy of the NeVa stent retriever in the treatment of large vessel occlusion strokes. Up to 600 subjects will be enrolled at up 30 sites.

Eligibility Criteria:
Inclusion Criteria:

Only subjects already treated with the NeVa thrombectomy devices can be considered for enrollment.

1. Age ≥18
2. NIHSS score ≥ 6
3. Pre-stroke mRS score ≤ 1
4. Intracranial arterial occlusion of the distal intracranial carotid artery or middle cerebral artery (M1/M2), anterior cerebral artery (ACA), posterior cerebral artery (PCA), basilar artery, or vertebral artery demonstrated with DSA.
5. Thrombectomy procedure can be initiated within 24 hours from symptom onset (defined as time last known well \[TLKW\])
6. Imaging Inclusion Criteria:

   The patient should have confirmed LVO and salvageable penumbra. Any automated software for determine the volume of viable tissue is acceptable. patient selection should follow the following guidelines:
   * ASPECTS 6-10 if treatment started 0-6 hours from TLKW
   * ASPECTS 8-10 if treatment started 6-24 hours from TLKW
   * Ischemic core ≤ 50 cc
7. Subject or legal representative is able and willing to give informed consent within 72 hours after the intervention (may use independent physician consent in this timeframe and gain subject or legal representative consent later than 72 hours).

Exclusion Criteria:

1. Pre-existing medical neurological or psychiatric disease that would confound the neurological or functional evaluations, e.g. dementia with prescribed anti-cholinesterase inhibitor (e.g. Aricept).
2. Cardiopulmonary resuscitation, significant cardiac arrhythmia, evidence of ongoing myocardial infarction, concern for pre- treatment pulmonary aspiration.
3. Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories
4. Cerebral vasculitis
5. History of severe allergy to contrast medium.
6. Known allergy to NeVa materials (nitinol, stainless steel)
7. Suspicion of aortic dissection, septic embolus, or bacterial endocarditis
8. Systemic infection
9. Significant mass effect with midline shift
10. Evidence of intracranial tumor (except small meningioma)
11. Inability to deploy NeVA device for at least one pass for any other reason
12. Life expectancy less than 6 months
13. Any other condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the subject if an endovascular procedure was performed.
A Study of JNJ-86974680 in Participants With Advanced Non-small Cell Lung Cancer

The purpose of this study is to determine a safe and tolerable dose(s) of JNJ-86974680 for further research in combination with cetrelimab and radiation therapy.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with histologically or cytologically confirmed stage IIIB-IV non-small cell lung cancer (NSCLC)
* Part 1: NSCLC with a known actionable genetic mutation (for example, epidermal growth factor receptor \[EGFR\], anaplastic lymphoma kinase \[ALK\], c-ros oncogene 1 \[ROS1\], v-raf murine sarcoma viral oncogene homolog B1 \[BRAF\]) must have received all approved targeted therapies and have progressed
* Part 2: No targetable mutations (for example, EGFR \[epidermal growth factor receptor\], ALK \[anaplastic lymphoma kinase\], ROS1\[c-ros oncogene 1\], and BRAF \[B-Raf proto-oncogene, serine/threonine kinase\])
* Part 1 and Cohort A of part 2: Must have been treated with (a) anti-programmed death protein 1 (anti-PD-1) or programmed cell death ligand 1 (PD-L1) therapy and (b) platinum-based chemotherapy
* For Cohort B of Part 2: Previously treated with anti-PD-1/PD-L1 therapy for metastatic disease as the prior line of therapy
* For Cohort C of Part 2: Treatment naïve
* Adequate organ function

Exclusion Criteria:

* Active central nervous system (CNS) disease involvement
* Active autoimmune disease
* Active infection
* History of solid organ or hematologic stem cell transplantation
AutoSet for Her Quality of Life Clinical Trial

Obstructive sleep apnea (OSA) has detrimental effects on the health and quality of life of suffers. Recent literature has shown that females may be particularly susceptible to adverse the quality of life effects, and that female obstructive sleep apnea manifests differently than male obstructive sleep apnea. A new AutoSetting Positive Airway Pressure (PAP) device has been designed specifically to treat female OSA. In this Cohort study, female patients who are newly diagnosed with OSA will be asked to complete various questionnaires relating to their quality of life. Patients will then use the AutoSet for Her for three months. At the completion of the three months the questionnaires will be repeated. Before treatment and after treatment quality of life will be compared to determine if treating female specific OSA in these patients improves quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Females aged ≥ 18 years
* Diagnostic PG/ PSG showing at least moderate OSA (AHI ≥ 15)
* Indication for PAP
* Participants willing and able to give written informed consent
* Ability to tolerate PAP therapy

Exclusion Criteria:

* Participants currently using CPAP or who have previous experience with CPAP
* Participants currently using supplemental oxygen
* Participants who are pregnant or planning to become pregnant in the next 3 months
Early Functional Proprioceptive Stimulation Post-stroke

The main objective of our study is to evaluate the impact of the use of Functional Proprioceptive Stimulation (FPS) on the recovery of the postural and motor functional capacities of the patient in the subacute phase of a stroke.

The hypothesis is that the use of FPS has a positive impact on the recovery of the patient's functional abilities, as well as on the duration of treatment until the sit/stand transfers are completed.

To evaluate this potential effect,there will be a randomization with two groups : one will have 5 sessions a week for 6 weeks maximum of SPF and the other groupe will have the same sessions but with the device stettled but not activated.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient hospitalized at Cimiez University Hospital;
* Ischemic or hemorrhagic cerebrovascular accident (CVA) of less than two weeks;
* Hemiparesis requiring rehabilitation treatment;
* Patient with a SFPASS score ≤ 6;
* Patient affiliated to or beneficiary of a social security scheme;
* Signature of informed consent

Exclusion criteria :

* NIHSS \> 20;
* Muscle spasticity of the lower limbs requiring botulinum toxin injection
* Inability to understand rehabilitation instructions;
* Vulnerable people
* Pregnant women, parturients and breastfeeding mothers, persons deprived of their liberty by a judicial or administrative decision, persons hospitalized without consent and persons admitted to a health or social establishment for purposes other than research,
* Adults who are subject to a legal protection measure or who are unable to express their consent.
Optimal Dosage of Ticagrelor in Korean Patients With AMI

East Asian patients will be required optimal dose of newer P2Y12 inhibitor (ticagrelor) to determine the safer treatment and better outcome. Whether low dose of ticagrelorI is more adequate for clinical practice in Korea is unclear. Therefore, the investigators aim to evaluate efficacy and safety of low dose of ticagrelor in Acute Myocardial Infarction (AMI) undergoing percutaneous coronary intervention(PCI).

In recent years, newer oral P2Y12 receptor blocker (ticagrelor) has been strong recommendations for management of patients with AMI undergoing (PCI). This drug provided more profound inhibitory effects than clopidogrel, which could lead to marked reduction in ischemic events, with relatively increase in bleeding complication, specific to low body weight, especially in women and East Asian patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients present with acute myocardial infarction undergoing PCI.
* Patients receiving ticagrelor; Male or female gender; Age 20-75 years.
* Patients provide written informed consent prior to enrollment.

Exclusion Criteria:

* Low body weight (\<60kg).
* History of hemorrhagic stroke.
* History of upper gastrointestinal bleeding in recent 6 months.
* Bleeding tendency.
* Thrombocytopenia defined by platelet \< 100,000/ml.
* Anemia defined by hemoglobin \< 10 g/dl.
* Renal dysfunction defined as serum creatinine \> 2.5 mg/dl.
* Severe hepatic dysfunction defined as serum transaminase \> 3 times normal limit.
* Known severe chronic obstructive pulmonary disease or bradycardia (sick sinus syndrome (SSS) or high degree AV block without pacemaker protection).
* Current treatment with drugs interfering with CYP3A4 metabolism (to avoid interaction with Ticagrelor): Ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and telithromycin.
The Safety, Tolerability and Efficacy of Multiple Subcutaneous Injections of SHR-1209 in Subjects With Hyperlipidemia

This is a randomized, double-blind, placebo- controlled phaseⅠb/Ⅱclinical study. Totally 108 subjects are planned to enrolled with 36 subjects in three low-dose groups (group 1, group 2 and group 3) and 72 subjects in three high-dose groups (group 4, group 5, and group 6).12 subjects with hyperlipidemia who received statin stable treatment for more than 28 days are enrolled in each low-dose group, randomly given SHR-1209 or placebo treatment at a ratio of 5:1. 24 subjects with hyperlipidemia who received statin stable treatment for more than 28 days are enrolled in each high-dose group, randomly given SHR-1209 or placebo treatment at a ratio of 5:1. The primary objective of this study is to evaluate the safety, tolerability, and efficacy of multiple subcutaneous injections of SHR-1209 in hyperlipidemia subjects treated with stabilized dose of statin. Groups detail as follows:

1. SHR-1209 dose 1 /placebo frequence 1
2. SHR-1209 dose 2 /placebo frequence 2
3. SHR-1209 dose 3 /placebo frequence 3
4. SHR-1209 dose 4 /placebo frequence 1
5. SHR-1209 dose 5 /placebo frequence 2
6. SHR-1209 dose 6 /placebo frequence 3


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 and ≤65 years old;
2. Subjects who are receiving statin therapy at the time of screening or who are eligible for statin therapy can randomized to receive a stable dose of statin therapy for more than 28 days and are willing to maintain stable statin therapy in this study;
3. Low-density lipoprotein cholesterol (LDL-C) level ≥2.6mmol/L of subjects who receiving statin and/or other lipid-lowering therapy at the time of screening, or LDL-C≥ 3.4mmol/L of subjects who didn't receive any-lowering therapy at the time of screening, and LDL-C still ≥2.6mmol/L before randomization;
4. Fasting triglycerides ≤4.5 mmol/L;
5. Body mass index (BMI) ≥18 and ≤ 35 kg/m2;
6. Signed informed consent.

Exclusion Criteria:

1. A clinical history of drug allergy or a history of atopic allergic diseases (asthma, urticaria, eczema dermatitis) or a known allergy to experimental or similar experimental drugs;
2. Diagnosis of homozygous familial hypercholesterolemia;
3. New York heart association (NYHA) defined Ⅱ - Ⅳ history of heart failure;
4. History of acute coronary syndrome (e.g. myocardial infarction, hospitalization for unstable angina), or percutaneous coronary intervention, or coronary artery bypass graft, or history of cerebrovascular disease, within 12 months prior to screening;
5. Uncontrolled severe arrhythmias that are not controlled by drugs or other therapy within 12 months prior to enrollment;
6. Uncontrolled hypertension (systolic blood pressure ≥ 160 and/or diastolic blood pressure ≥ 100 mmHg);
7. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or gamma pancreatic acyl transferase (GGT), more than 2.5x ULN;
8. Subjects with previous malignant tumor diseases. etc.
Fractionated Vs Single Dose Injection for Spinal C-Section in Patients With Pregnancy-Induced Hypertension

The aim of this study was to compare haemodynamic changes, total dose of ephedrin requirement, and level of sensory blockade between fractionated dose and single dose spinal anesthesia injection in obstetric patients with pregnancy-induced hypertension who underwent Caesarean section

Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study and randomized into two groups; single dose (SD) and fractionated dose (FD). All subjects will receive spinal anesthesia with 2,5 ml of 10 mg bupivacaine hyperbaric 0,5% and fentanyl 25 mcg. After IV cannulas (18 - 20 G) were properly placed, premedication with intravenous (IV) ranitidine 50 mg and metoclopramide 10 mg were given. Additional IV access was added if MgSO4 must been continuously administered intravenously perioperatively. Standard monitor device were placed after patients had been transferred to operating room. Additional premedication such as intravenous midazolam 0.02 mg/BW or fentanyl 1 mcg/BW were given if the patients were anxious or in pain. Baseline haemodynamic measurement was done two minutes after premedication. Spinal anesthesia was performed while patients in sitting position at L3-4 or L4-5 level with median or paramedian approach, with total dose 2,5 ml of 10 mg bupivacaine hyperbaric 0,5% and fentanyl 25 mcg. After skin wheal of lidocaine at the intended spinous interspace were placed, spinal needle (SpinocanR, B Braun, 27 G) were inserted and advanced until subarachnoid space were reached. In group FD, 1,5 ml of total dose followed by 1 ml remaining dose after 90 s interval were given. In SD group, 2,5 ml total dose were given with 0.2 ml/second rate, and subjects were asked to remain sitted for 90 seconds. If there were more than three injection attempts, the patients were excluded from the study. Co-loading 5 - 10 ml/kg ringer lactate in 20 minutes were given for all subjects.

Eligibility Criteria:
Inclusion Criteria:

* with hypertension in pregnancy (gestational hypertension or preeclampsia)
* ASA II-III
* aged 18 - 40 years
* BMI 18.5 - 35 kg/m2
* singleton pregnancy
* would undergo spinal anesthesia for emergency or semi-emergency caesarean section

Exclusion Criteria:

* chronic hypertension
* eclampsia
* pulmonary edema
* cerebrovascular diseases
* type-2 diabetes mellitus and gestational diabetes
* placental abruption/previa/accreta
* umbilical cord prolapse
* gestational age \<34 weeks
* estimated fetal weight \<=2.300 gram and \>=4.000 gram
* polyhydramnios
* fetal distress
Efficacy of Doxycycline in the Treatment of Early Stages of Mycosis Fungoides

Current study aims at assessing the efficacy of doxycycline as a potential treatment modality for early stages of MF.

Objectives

Objective is to evaluate the efficacy of doxycycline in treatment of early stages of mycosis fungoides (IA, IB and IIA) and to assess its apoptotic enhancing effect by studying the expression of BCL2 by the T lymphocytes.

Study Design

Randomized controlled trial

Population of study \& disease condition

30 patients with early stage mycosis fungoides (Stage Ia,Ib and IIa)

Methodology in details

After signing an informed consent, each participant will be subjected to:

I. Baseline evaluation:

1. Baseline biopsy to document the current state of the disease and to assess immunohistochemically the expression of CD3 and Bcl2 by the lymphocytes.
2. Detailed history taking including onset, course, duration of the disease and history of any previous treatments used.
3. Detailed examination of skin lesions and scoring using:

   * Modified Severity of Index Weighted Assessment (mSWAT)
   * Composite Assessment of Index Lesion Severity (CAILS)
4. Pruritus scoring using a visual analog scale from 0-10, where 0=no pruritus and 10=worst imaginable pruritus
5. Photography

II. Treatment and dosing protocol:

Participants will be randomly allocated in either one of the treatment groups:

Group A: Will receive oral doxycycline in a dose of 200 mg daily for three months.

Group B: Will receive PUVA with dosing \& increments according to the standard protocols of the Phototherapy Unit, Dermatology Department, Cairo University; 3 sessions per week for 3 months.

III. Timings of follow up visits and clinical assessments done:

Patients will be regularly assessed at weeks 4, 8, and 12. Patients continuing for another three months, as mentioned above, will be assessed at weeks 16, 20 and 24. The following will be done at these follow up visits: mSWAT, CAILS, pruritus scoring and photography. Side effects will be monitored and managed accordingly.

IV. Follow up biopsies:

A repeat biopsy will be taken at initial improvement in CAILS (or at week 12) for immunohistochemical re-assessment of the expression of CD3 and Bcl2 by the lymphocytes.

Eligibility Criteria:
Inclusion Criteria:

* Adults (above 18) of either sex with established diagnosis of classic MF

Exclusion Criteria:

* Any variant of MF other than the classic variant.
* Advanced stages of classic MF: Stage IIb, III or IV.
* Pregnant and lactating females.
* Patients with autoimmune diseases e.g. SLE
* Patients with solid or hematological malignancies e.g. breast cancer, leukemia, etc.
* Patients with any contraindications for doxycycline (eg: liver disease, kidney disease, photosensitivity, peptic ulcer or patients receiving systemic retinoids).
* Patients with any contraindication to phototherapy (eg: any other skin cancers or photosensitivity); or to psoralen (eg: liver disease)
A Digital Balance Program With Comparison Group

This research study evaluates a digital musculoskeletal care program specifically focused on balance improvement and falls prevention. The primary goal is to determine if the program results in fewer falls compared to a comparison condition where people will get educational/information articles on falls prevention. Study participants are asked to participate in their assigned condition and complete surveys throughout the study.

The digital Balance Program is accessible through a smartphone or tablet and includes tailored exercise therapy, educational content spanning a variety of topics related to balance improvement and fall prevention, a personalized clinical approach to improving balance, and access to a board-certified health coach and physical therapist. The comparison group consists of a series of emailed articles on falls prevention. In addition to participating in the assigned condition, participants are asked to answer surveys that ask questions related to your balance, mental health, demographic information, and lifestyle. The surveys are sent before, during and at the end of the program.

Eligibility Criteria:
Inclusion Criteria:

* had an email account and owned a smartphone
* had a moderate-high fall risk based on the Stopping Elderly Accidents, Deaths, and Injuries (STEADI) questionnaire (≥ 4 points)

Exclusion Criteria:

* undergone musculoskeletal surgery within three months prior to recruitment
* a history of opioid, alcohol, or drug abuse within the last year
* a diagnosis of cognitive, behavioral, neurologic, or psychiatric disorders
* any contraindication for light physical activity as directed by the prospective participant's doctor