cyrilzakka/clinical-trials huggingface dataset:
Phase I/II Safety Study of IPI-504 in Relapsed/Refractory Stage IIIb, or Stage IV Non-small Cell Lung Cancer (NSCLC)

The purpose of this study is to determine the safety, tolerability and maximum tolerated dose of IPI-504 in patients with non-small cell lung cancer (NSCLC). The study will examine how IPI-504 is absorbed, distributed, metabolized and eliminated by the body. The study will also evaluate the anti-tumor activity of IPI-504.

IPI-504 is a novel small molecule inhibitor of heat shock protein 90 (Hsp90), an emerging and recently identified target for cancer therapy. Hsp90 is a protein chaperone that plays a central role in maintaining the proper folding, function and viability of various "client proteins". Many of the client proteins stabilized by Hsp90 are oncoproteins and cell-signaling proteins important in cancer cell proliferation and cancer cell survival. This clinical trial will study the effects of IPI-504 in a molecularly defined sub-group of patients who carry client proteins found in non-small cell lung cancer.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed diagnosis of a Stage IIIb (with malignant pleural or pericardial effusion) or Stage IV NSCLC
* Measurable disease by RECIST criteria.

Exclusion Criteria:

* Treatment for NSCLC with any approved or investigational product within 2 weeks of the start of IPI-504 treatment for any small molecule therapy; within 4 weeks of the start of IPI-504 treatment for any biologic or any conventional chemotherapy.
* Inadequate hematologic or renal or hepatic function
* Previous treatment with 17-AAG, DMAG or other known Hsp90 inhibitor.
Clavulanic Acid for the Treatment of Cocaine Use Disorder

A dose escalation study to assess the efficacy and safety of Clavulanic Acid (CLAV) vs. placebo (PBO) for the treatment of cocaine use disorder (CUD)

This pilot study is indicated for treatment of moderate to severe cocaine use disorder. It is a randomized, placebo-controlled, parallel group, multi-center pilot study to compare the efficacy of 500-750mg/day clavulanic acid vs. placebo in addition to weekly medication management therapy. Subjective, cognitive, and adverse effect assessments, blood pressure and pulse will be performed 1-3 times weekly.

Eligibility Criteria:
Inclusion Criteria:

* Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures
* Be male or female adult volunteers ages 18-70 inclusive.
* Have a Diagnostic and Statistical Manual (DSM-V) diagnosis of cocaine use disorder, moderate to severe in early remission with a duration of regular (weekly or more) cocaine (either snorted, smoked or injected) for at least one year.
* Have a history and brief physical examination that demonstrate no clinically significant contraindication for participating in the study, and/ or significant or unstable medical or psychiatric illness.

Exclusion Criteria:

* Meets DSM-V criteria for dependence on any substance other than cocaine and mild to moderate alcohol or marijuana (except nicotine or caffeine), determined by the structured clinical interview for DSM-V.
* Allergy to clavulanic acid, penicillin, or any beta-lactam drug.
* Meets current or lifetime DSM-V criteria for schizophrenia or any psychotic disorder or organic mental disorder. Subject meets current DSM-V diagnosis of any other clinically significant psychiatric disorder that will interfere with study participation.
* Severe physical or medical illnesses such as AIDS or active hepatitis.
* If female, tests positive on a pregnancy test, is contemplating pregnancy in the next 6 months, is nursing, or is not using an effective contraceptive method (if relevant)
Patient-reported Outcomes After Percutaneous Coronary Intervention

The main objective is to investigate i) continuity of care, ii) health literacy and self-management, iii) adherence to treatment, and iv) patient preferences, healthcare utilization and costs, and to determine associations with future short- and long-term health outcomes in patients after percutaneous coronary intervention.

CONCARD will use multiple designs. (1) An inductive exploratory design including in-depth interviews on patients' experiences of healthcare delivery will provide a context for the quantitative data to develop the content of the cohort study and trial intervention. (2) A prospective cohort design with a 1-year follow-up period will include data on patient-reported outcomes, and a 10-year follow-up for adverse events. In translation and adaptation of patient-reported outcome measures, a methodological design will be applied. (3) A discrete choice experiment will investigate patient preferences for aftercare and cardiac rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing percutaneous coronary intervention
* ≥ 18 years of age
* Living at home at the time of inclusion.

Exclusion Criteria:

* Patients who do not speak Norwegian/Danish
* Patients who are unable to fill in the questionnaires due to reduced capacities
* Institutionalized patients
* Patients with expected lifetime less than one year
* Percutaneous coronary intervention without stent implantation
* Patients undergoing percutaneous coronary intervention related to Transcatheter Aortic Valve Implantation or Mitraclip examination
* Previous enrollment in CONCARD (readmissions).
Amyotrophic Lateral Sclerosis (ALS) Families Project

This program provides family members of individuals with familial ALS the opportunity to contribute to research focused on learning more about why motor neuron degeneration begins and how or why it progresses. This study provides genetic counseling and testing to help participants understand and manage their risk and determine if they want to learn their genetic status. This study will follow unaffected ALS gene mutation carriers on an annual basis to gather essential information that will ultimately help researchers develop novel therapies for the prevention and treatment of ALS.

Approximately 10% of people with amyotrophic lateral sclerosis (ALS), or Lou Gehrig's Disease, have a family history of ALS or a related condition called frontotemporal dementia (FTD). In most of these familial cases, and a significant number of "sporadic" patients with no family history, a mutation is present in one of a growing number of genes that have been associated with ALS and/or FTD.

The ALS Families Project will study unaffected carriers of ALS/FTD-associated gene mutations to investigate the first steps in the disease process that leads to motor neuron degeneration, with the goal of identifying early disease targets and points of intervention to slow or stop disease onset and progression.

Unaffected individuals who have either a family member with a known ALS/FTD-associated gene mutation or have a strong family history of ALS and FTD are invited to participate in the ALS Families Project. For those who enroll, research visits will occur every 6-12 months.

Eligibility Criteria:
Inclusion Criteria:

* Men or women of any race or ethnicity aged 18 or older
* No symptoms of ALS or fronto-temporal dementia at enrollment
* Scenario 1: has already had genetic testing that identified an ALS-spectrum gene mutation.
* Scenario 2: has a first degree relative who was/is an obligate carrier of a familial ALS-spectrum gene mutation.
* Scenario 3: has a first degree relative who has/had an ALS-spectrum diagnosis who had a confirmed ALS-spectrum gene mutation or comes from a family with a high burden of ALS-spectrum diagnoses and a known ALS-spectrum gene mutation.
* Scenario 4: is deemed to be at high risk for carrying an ALS-spectrum gene mutation as judged by a review of the family structure and genetic information by the study team.
* Willing to undergo genetic analysis, with option of whether or not to learn results
* Willing to travel to Columbia University Irving Medical Center (CUIMC) every 6-24 months for study procedures
* Capable of providing informed consent and following study procedures, or has a legally authorized representative who is able to consent for the subject.

Exclusion Criteria for participation in biosample portion of the study:

* Known HIV
* Known hepatitis B
* Known hepatitis C
Acupoint Massage Combined With Ear Point Pressing Beans

Objective: To explore the application effect of acupoint massage combined with ear point pressing beans in the remission stage of asthma. Methods: 120 children with asthma in remission who were treated in pediatric outpatient department from January 2016 to October 2022 were randomly divided into experimental group and control group, with 60 cases in each group.The patients in both groups were treated with salmeterol and fluticasone inhalation powder once a day, twice a day. The patients in the control group were treated with acupoint massage on this basis. Acupoint massage once a day from Monday to Friday, lasting for 30 minutes each time.The patients in the experimental group were treated with ear point pressing beans on the basis of the control group. The ear point pressing beans is performed once a day from Monday to Friday. Changes in pulmonary function and asthma control were observed before and after treatment in the two groups were observed, and forced expiratory volume 1 second (FEV1),forced expiratory vital capacity (FVC), FEV1/FVC, asthma control test scale (ACT) score were compared.


Eligibility Criteria:
Inclusion Criteria:

* The patient met the diagnostic criteria of asthma remission in the Guidelines for prevention and treatment of bronchial asthma；
* 1\~18 years old, course of disease \> 1 year;
* Patients with complete clinical data and able to cooperate with treatment.

Exclusion Criteria:

* Patients with other cardiopulmonary system diseases or myasthenia gravis;
* Eczema, ulcer or other symptoms in the auricle or skin;
* Illiteracy, cognitive, language or communication disorders;
* The patient has taken medication for asthma treatment within 3 months.
Confirmatory Study of OPC-12759 Ophthalmic Solution

The purpose of this study is to verify whether OPC-12759 ophthalmic solution is effective compared with placebo in dry eye patients. OPC-12759 ophthalmic suspension will be used as a reference drug.


Eligibility Criteria:
Inclusion Criteria:

1. Out patient
2. Subjective complaint of dry eye that has been present for minimum 20 months
3. Ocular discomfort severity is moderate to severe
4. Corneal - conjunctival damage is moderate to severe
5. Unanesthetized Schirmer's test score of 5mm/5minutes or less
6. Best corrected visual acuity of 0.2 or better in both eyes

Exclusion Criteria:

1. Presence of anterior segment disease or disorder other than that associated with dry eye
2. Ocular hypertension patient or glaucoma patient with ophthalmic solution
3. Anticipated use of any topically-instilled ocular medications or patients who cannot discontinue the use during the study
4. Anticipated use of contact lens during the study
5. Patient with punctal plug
6. Any history of ocular surgery within 12 months
7. Female patients who are pregnant,possibly pregnant or breast feeding
8. Known hypersensitivity to any component of the study drug or procedural medications
9. Receipt of any investigational product within 4 months.
OPtimal stEnt Deployment stRategy oF Contemporary sTents - Registry to Evaluate Percutaneous Coronary Intervention Using Bioresorbable Scaffolds With Thinner-strut Construction and Guidance by intracOronary Imaging to REduce Scaffold Failure

Implantation of a metallic drug-eluting stent (DES) is currently the gold standard in percutaneous coronary intervention (PCI). However, a DES has several limitations on the long-term, such as chronic local inflammation which may lead to in-stent restenosis, absence of physiological coronary vasomotion and vessel caging which makes future coronary artery bypass grafting (CABG) impossible. A bioresorbable scaffold (BRS) is designed to overcome these limitations. The first generation BRS was shown to be clinically inferior to DES due to a slightly higher rate of stent thrombosis. To overcome this problem, several scientific developments have been achieved in the past few years, such as thinner BRS strut construction and improved implantation technique by using intracoronary imaging guidance with optical coherence tomography (OCT) or intravasculair ultrasound (IVUS). The investigators hypothesize that combining the use of a second generation thin-strut BRS and a protocolized implantation technique with intracoronary imaging guidance leads to favourable clinical outcomes. The aim of this study is to evaluate clinical outcome after protocolized intracoronary imaging-guided PCI with implantation of a second generation thin-struts BRS.


Eligibility Criteria:
Inclusion Criteria:

1. Stable coronary artery disease with one or more significant epicardial stenosis in native coronary arteries suitable for OCT or IVUS-guided PCI with BRS implantation.
2. Subject must be at least 18 years of age
3. Written consent to participate in the study

Exclusion Criteria:

1. Culprit lesions in the setting of acute coronary syndrome.
2. Lesions with severe calcification.
3. Lesions in a coronary artery with severe tortuosity.
4. Left main coronary artery lesions.
5. Bifurcation lesions.
6. Ostial lesions.
7. Lesions with a difference in proximal and distal reference diameter of \>0.5 mm by visual judgement of the coronary angiogram by the treating operator.
8. Treatment of in-stent restenosis or stent thrombosis.
9. History of definite stent thrombosis.
10. Lesions in coronary artery bypass grafts.
11. Lesions not suitable for OCT or IVUS catheter delivery and imaging, e.g. due to tortuosity or distal localisation.
12. Creatinine Clearance ≤ 30 ml/min/1.73 m2 as calculated by MDRD formula for estimated GFR.
13. Contraindication to dual antiplatelet therapy with aspirin and a P2Y12 inhibitor or (if indicated) NOAC and P2Y12 inhibitor.
14. Planned non-deferrable major surgery after PCI.
15. Known comorbidity associated with a life expectancy \<1 year.
16. Unable to understand and follow study-related instructions or unable to comply with study protocol.
Clinical Study to Evaluate the Blood Triglyceride Decreasing Effect and Safety of Korean Post-Fermented Tea Extracts

This study was conducted to investigate the effects of daily supplementation of Korean Post-Fermented Tea(Heukcha) Extracts on improvement of Blood Triglyceride Level.

This study was a 8 week, randomized, multicenter, double-blind, placebo-controlled, parallel-design human trial.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects older than 19 years old
* Who has fasting blood triglyceride levels ≥ 150 mg/dL
* Who voluntarily agreed to participate in the study and signed an informed consent form

Exclusion Criteria:

* Those who are taking functional food designed for dyslipidemia reduction within 4 weeks before study participation
* Those who have been diagnosed and are on medication with dyslipidemia, cardiovascular disease, kidney disease, liver disease or thyroid disease within 4 weeks before study participation
* Fasting plasma glucose \>126 mg/dL or treatment with medications including oral hypoglycemic agents or insulin
* Who has used or is expected to inevitably use prohibited concomitant medications during the study
* Women who is pregnant /breast-feeding, or who has childbearing potential and does not use available contraceptives
* Who has dosed other study medications within 30 days before screening
* Who is determined ineligible for study participation by investigators for any other reasons
Lesion Network MApping Navigated Continuous Theta-burst STimulation for Motor REcovery in Acute Ischemic Stroke

This is a multicenter, sham-controlled, double-blind, randomized clinical trial to evaluate the efficacy and safety of lesion network mapping navigated cTBS in improving motor function in patients with acute ischemic stroke at 3-14 days after onset.

The target population of this study was patients with acute ischemic stroke. Lesion network mapping and navigation were used to select individual stimulation targets. Enrolled patients were randomly assigned in a 1:1 ratio to the "cTBS group" or the "Sham stimulation group" and received:

cTBS group: Based on the map, an 8-shaped coil was used to stimulate the motor function-related targets. The stimulation intensity was RMT80%, 600 pulses, 50Hz, 40s per target, and the stimulation interval was more than 2 hours. The total course of treatment lasted 7 days.

Sham stimulation group: A Sham stimulation coil was used to stimulate based on the map. The sound and duration were the same as the cTBS group, ensuring no effective stimulation. The total course of treatment lasted 7 days.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-80 years old.
2. Acute ischemic stroke confirmed by CT or MRI at 3-14 days after onset.
3. Pre-stroke modified Rankin scale (mRS) score≤1.
4. 4≤NIHSS score≤ 25, 1a≤1, NIHSS5a/5b/6a/6b≥2 at least.
5. Moderate or severe motor dysfunction (Fugl-Meyer motor score \< 80).
6. Written informed consent from patients or their legally authorized representatives.

Exclusion Criteria:

1. TMS contraindications include metallic foreign bodies in the head, pacemaker, implantable drug pumps, cochlear implants, etc.
2. Epilepsy or history of epilepsy, intracranial hypertension, tumor and other serious neurological disorders;
3. Midline displacement and brain parenchymal mass effect seen in head CT and other images;
4. Head CT or MRI showed bilateral acute cerebral infarction;
5. Evidence of acute intracranial hemorrhage;
6. A history of congenital or acquired hemorrhagic disease, coagulation factor deficiency, or thrombocytopenia disease;
7. After blood pressure control, the systolic blood pressure was still ≥180 mmHg or the diastolic blood pressure was ≥110 mmHg;
8. Patients during pregnancy or lactation and within 90 days of planned pregnancy;
9. Patients with severe mental disorders or dementia who can not cooperate with informed consent and follow-up;
10. Patients with malignancy or severe systemic disease and expected survival of less than 90 days;
11. Participants in other clinical intervention studies within 30 days before randomization or who were participating in other clinical intervention studies.
12. Patients with ataxia (NIHSS 7 ≥ 1) and aphasia (NIHSS 9 ≥ 2).
Confirm Rx Insertable Cardiac Monitor SMART Registry

The purpose of the Confirm Rx SMART Registry is to collect real world data to assess the safety and performance of the Confirm Rx Insertable Cardiac Monitor (ICM) and system over a 12 month period. A sub-set of subjects enrolled in the Confirm Rx SMART Registry will meet the Post Market Clinical Follow-Up (PMCF) requirement for CE mark.


Eligibility Criteria:
Inclusion Criteria:

* Have an approved indication for continuous arrhythmia monitoring with an ICM
* Have a cellular phone or the ability or willing to use a St. Jude Medical mobile transmitter that is compatible with the MyMerlin App and able to communicate with the Confirm Rx ICM device.
* Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
* Are 18 years of age or older, or of legal age to give informed consent specific to state and national law.

Exclusion Criteria:

* Subject is implanted with or indicated for implant with a pacemaker, implantable cardioverter defibrillator (ICD), or cardiac resynchronization therapy (CRT) device.
* Enrolled or intend to participate in a clinical drug and/or device study, which could confound the results of this trial as determined by the sponsor, during the course of this clinical study.
* Have a life expectancy of less than 1 year due to any condition.
* Have a previous ICM placement.
An Interventional Study to Compare the Efficacy and Tolerability With Targin® in Non-malignant Chronic Pain (GLORY)

Objectives:

1. Objective of main interest

   - To assess the drop-out rate caused by adverse event\* after 6 weeks treatment
2. Further objectives

   * To assess the drop-out rate caused by adverse event\* after 1 week treatment
   * To assess the pain reduction rate after 6 weeks treatment from baseline
   * To assess the Euroquol (EQ-5D) quality of life
   * To assess physician's overall satisfaction
   * To assess subject's overall satisfaction
   * To assess safety

Study Design (Methodology):

This will be a single center, open-label, randomised, phase IV, exploratory interventional study to compare the efficacy and tolerability of current titration patterns and slow titration pattern with Targin® (Oxycodone/Naloxone) in the treatment of moderate to severe non-malignant chronic pain patients who are dissatisfied with their current analgesic medication World Health Organisation (WHO) step II analgesics).

Upon providing written informed consent, subject will be screened in the study and assessment will be performed at that time such as safety laboratory assessments, physical examination, vital sign, medical history taking, 24 hours pain intensity score. If the patient is eligible in inclusion/exclusion criteria at the time of visit 1, the patient will be randomized in a 1:1 ratio to allocate in Group A or Group B. Re-screening, study drug dose interruption is not allowed.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 20 and \<80 years of age
* Patients who have non-malignant chronic pain(≥90 days)
* Patients who have moderate to severe pain intensity which is not controlled with non-strong opioid
* Naïve patients for Oxycodone/Naloxone (Naïve patient defined as who did not treated for 90 days)
* Naïve patients for strong opioid (Naïve patient defined as who did not treated for 90 days)
* Patients who signed a written informed consent form

Exclusion Criteria:

* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine pregnancy test
* Patients with known hypersensitivity to Oxycodone/Naloxone or to any of the excipients
* Patient who needs acute dose titration or whose pain intensity fluctuate significantly in a short period according to investigator's judgment
* Having used other investigational drugs at the time of enrollment, or within 30 days of enrollment
Hemp Oil + User Experience Study

Presented as an online survey, this study seeks to better understand how Thorne customers are using and experiencing the new Hemp Oil + product and how they feel it compares in the marketplace. Hemp Oil + is a combination product with a proprietary blend of hemp, clove, black pepper, hops, and rosemary extracts. People who have independently elected to purchase and use Hemp Oil + before the study starts will be invited to voluntarily participate. If they meet study requirements and give consent they will answer questions online about their experience with Hemp Oil +. Questions address general demographics and wellness, general impressions of the product, how it compares to other products, and any effect it has had on their gastrointestinal health, physical discomfort, sleep, and mood. The survey is expected to take 15-30 min of participant time. Data will be analyzed to determine whether the customer experience with Hemp Oil + is as favorable as it seems from anecdotal reports. Analysis will also be conducted to find patterns that can inform future studies, marketing, and customer education efforts.


Eligibility Criteria:
Inclusion Criteria:

* Has personally used at least one bottle (30 gelcaps) of Hemp Oil +
* Provides consent to participate in the study

Exclusion Criteria:

* Cannot access or use the electronic survey for any reason
* Was pregnant or nursing when taking Hemp Oil +
* Is a Thorne employee not willing to participate without compensation