cyrilzakka/clinical-trials huggingface dataset:
The Occurrence of MACE in Patients With AMI Receiving Pitavastatin/Valsartan Treatment

Prospective Observation study to identify the rate of MACE in AMI with Livalo V(Pitavastatin/Valsartan) for 12 month in Korea

Following subjects with AMI event within 1 month will be assessed MACE event for 1year

* Essential hypertension or heart failure
* Idiopathic hypercholesterolemia (heterogeneous familial and non-familial hypercholesterolemia, Fredrickson classification type IIa)
* Mixed-type hypercholesterolemia (Fredrickson classification type IIb) with acute myocardial infarction (STEMI, NSTEMI),

Eligibility Criteria:
Inclusion Criteria:

* idiopathic hypercholesterolemia (heterogeneous familial and non-familial, Fredrickson type IIa) or mixed-type (Fredrickson type IIb) with AMI (STEMI, NSTEMI), including essential hypertension or heart failure
* diagnosed AMI (STEMI, NSTEMI) 1 months ago
* more than 19 years old and more than 2 years of life expectancy at screening
* informed consent

Exclusion Criteria:

* cardiogenic shock or corresponding clinical events
* contraindicated to the IP
* unsuitable to this study judged by investigators
Assessment of the C8 Dermatomal Block with Photoplethysmographic Amplitude After Interscalene Brachial Plexus Block

The goal of this clinical trial is to investigate the effectiveness of photoplethysmographic amplitude in assessing the extent of anesthesia in the 8th cervical dermatome in patients undergoing interscalene brachial plexus block (ISBPB). The main question it aims to answer is

* Is there any difference in the post-block changes in photoplethysmographic amplitude measured from the ipsilateral 5th finger (supplied by the 8th cervical nerve root) between ISBPBs targeting the C5-to-C6 nerve roots and the C5-to-C8 nerve roots?
* Do the changes in photoplethysmographic amplitude represent the extent of anesthesia in the 8th cervical dermatome? Participants will receive either ISBPB targeting the C5-to-C6 nerve roots or the C5-to-C8 nerve roots, and then the changes in photoplethysmographic amplitude will be measured from the 5th finger ipsilateral to ISBPB.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status 1 or 2
* Schedule to receive interscalene brachial plexus block for arthroscopic shoulder surgery

Exclusion Criteria:

* Coagulopathy
* Peripheral vascular diseases
* Arrhythmias
* Cardiac conduction abnormalities
* A history of medication affecting cardiac conduction
* Ischemic heart disease
* Hypertension
* Diabetes mellitus
* Thyroid dysfunction
* Other medical conditions affecting autonomic nervous activity
* Infection at the skin area for interscalene brachial plexus block
* Peripheral neuropathy or neurologic sequelae in the upper limb ipsilateral to the surgery
* Allergy to local anesthetics or a history of allergic shock
* Contralateral vocal cord palsy, hemidiaphragmatic paresis/paralysis or pneumo/hemo thorax
* Severe restrictive pulmonary disorder
* Electrolyte imbalance
* Difficulty in communicating with medical personnel
* Patients refusal
Safer Still (Exploratory Project 3)

The long-term goal is to decrease suicide and suicidal behaviors in at-risk youth through preventative interventions. Investigators propose to develop an interactive intervention ("Safer Still") to help promote safe storage of firearms during the critical period immediately following high-risk care transitions. The objective of this study is to develop and test the Safer Still intervention as an efficient adjunct to traditional care for adolescents aged 12-17 years who are discharged from psychiatric hospitals and living in households where firearms are stored unsafely.

The objective of this study is to develop and test the Safer Still intervention as an efficient adjunct to traditional care for adolescents aged 12-17 years who are discharged from psychiatric hospitals and living in households where firearms are stored unsafely. Exploratory aims of the study are as follows: (1) Evaluate parental motivation to change firearm storage behavior as a potential mediator of the three-month intervention effect. Investigators hypothesize that higher change scores in the "action" stage of the readiness to change model1 at one month will mediate the intervention effect at three months; (2) Identify whether the response to the Safer Still intervention varies by adolescent history of suicide attempt and parental primary reason for firearm ownership at one and three months; and (3) Ascertain common parental reasons for declining to safely store firearms.

Eligibility Criteria:
Inclusion Criteria:

* Parent or legal guardian of an adolescent aged 12 to 17 years at time of consent
* Have a child who is receiving psychiatric inpatient, crisis, or emergency treatment at Nationwide Children's Hospital
* Indicate that at least one firearm is located in or around the residence of the adolescent and is stored unlocked, loaded, or both unlocked and loaded.
* Only one parent per household is permitted to participate to avoid contamination across the two study conditions.

Exclusion Criteria:

* Inability to speak/read English
* Lack access to a digital device (smartphone, iPad, tablet computer, desktop, laptop PC).
Multimedia Self-Management Intervention for Lung Cancer Surgery Family Caregivers and Patients

This randomized phase III trial studies how well a multimedia self-management intervention works in preparing family caregivers and patients with stage I-III lung cancer for lung cancer surgery. The multimedia self-management intervention, Preparing for your Lung Cancer Surgery, is a nurse-led, caregiver-based, multimedia intervention that may improve patient recovery after surgery, lower caregiving burden, and improve distress and quality of life.

PRIMARY OBJECTIVES:

I. Test the effects of the multimedia self-management (MSM) intervention on family caregivers (FCG) outcomes and cancer support services use at discharge and 3-month post-discharge, comparing intervention and attention control groups.

II. Test the effects of the MSM intervention on patient outcomes and healthcare resource use at discharge and 3-months post-discharge, comparing intervention and attention control groups.

III. Test the effects of the MSM intervention on outcome mediators at discharge and 3-months post-discharge, comparing intervention and attention control groups.

SECONDARY OBJECTIVES:

I. Explore moderators (age, sex, marital status, caregiver relationship to patient, caregiver employment status, co-morbidities) of FCG and patient outcomes and reciprocal relationships.

II. Determine, through exit interviews, participant's experience with the MSM intervention.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients and FCGs receive the MSM intervention consisting of videos, a handbook, and research nurse coaching over 40-60 minutes, approximately 3-7 days before surgery and within 24 hours of planned discharge. Patients and FCGs also receive research nurse support by telephone (separate sessions for FCGs and patients) over 20-30 minutes at 2 and 7 days, and 2 months post-discharge.

GROUP II: Patients and FCGs receive attention control intervention consisting of videos (American Cancer Society video on "Clinical Trials"), American Cancer Society print materials, and assistance from a clinical research associate (CRA) approximately 3-7 days before surgery and within 24 hours of planned discharge. Patients and FCGs also receive assistance from CRAs via telephone calls at 2 and 7 days, and 2 months post-discharge.

Eligibility Criteria:
Family Caregiver Inclusion Criteria:

* A family member or friend identified by the patient as being the primary care provider before and after surgery
* A patient/care recipient enrolled in the study
* Age 21 years or older
* Able to read or understand English

Patient Inclusion Criteria:

* Diagnosis of Stage I-III non-small cell lung cancer
* Scheduled to undergo surgery for treatment
* A family caregiver enrolled in the study
* Age 21 years or older
* Able to read or understand English.
Study of Psychopathological Characteristics of Patient Smoking in Thoracic Oncology

Persistent smoking after lung cancer has been the subject of medical, therapeutic and epidemiological publications for twenty years of research. Continued persistent smoking is all the more a problem for oncologists as there is evidence that smoking cessation, with lung cancer, gives therapeutic benefit. Quitting smoking can improve the response to treatments (chemotherapy, radiotherapy, surgery), quality of life and overall survival. However many patients refuse adhesion to tobacco cessation. Daily practice leads us to the hypothesis that adhesion differences aren't related to the denial of medical information, nor to resignation or to nicotine dependence. Patients who continue smoking seem to face a form of impossibility to wean. Cigarette seems to be felt as a part of their body in their narration and description of their body image.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 years or older
* Patient affiliated to a social security system
* Patient who has signed and dated informed consent, written before all procedures related to the study
* Patient who has received the results of the previous mandatory medical examination
* Patient who has been diagnosed with lung cancer, regardless of the histological type of the cancer
* Patient who maintains an active smoking at the time of inclusion
* Patient who has smoked at least one cigarette in the previous year of inclusion
* Patient who is being treated for lung cancer (surgery, chemotherapy, radiotherapy) and not another form of cancer
* Tobacco consumer's only by smoke inhalation
* Tobacco consumer's or tobacco associated with cannabis

Exclusion Criteria:

* Major patient under guardianship or curatorship or maintenance of justice
* Patient deprived of his liberty or in an emergency situation
* Patient with a Performance Statut(OMS) higher than 2 and/or with a psychiatric disorder like " schizophrenia and other psychotic disorders " (DSM IV)
* A palliative care patient
* Patient who began smoking during his diagnostic examination or after the diagnosis of cancer
* A pregnant or breastfeeding woman
* Patient in an exclusion period
Intracerebral Autologous Stem Cell Therapy for Chronic Stroke Patients

The goal of this clinical trial is to evaluate if autologous mesenchymal stem cell (HUNS001-01) transplantation therapy can provide neurological recovery in patients with chronic stage of stroke resulting in moderate to severe neurological sequelae. The main questions it aims to answer are:

Can HUNS001-01 intracerebral transplantation demonstrate improvement in the mRS of disability for 1 year after intervention? Can HUNS001-01 intracerebral transplantation can be performed without any adverse events for 1 year after intervention?

Participants will receive the below interventions.

* Screening for the eligibility to enroll the clinical trial (interview, blood test, imaging)
* Harvest of platelet concentrates (PC)
* Harvest of bone marrows (BM)
* Receive intracerebral transplantation surgery of HUNS001-01
* Post-operative rehabilitation
* Follow-up studies (until 1 year or termination of the trial)


Eligibility Criteria:
Inclusion criteria

1. Age between 20 and 70 years
2. Clinical diagnosis of ischemic stroke between 6 months and 5 years ago
3. Ischemic area in the territory of unilateral interanal cerebral artery
4. Moderate to severe neurological symptoms; mRS 3 or 4, and Brunnstrom stage Ⅲ or IV
5. Subjects with a DTI-RAINBOW (R-DTI) value of more than 70% at screening MR imaging
6. No significant neurological impairment before the stroke (Pre-stroke mRS of 0 or 1)
7. Subjects who can give informed consent by its self

Exclusion criteria

1. Subject showing severe lower extremity contracture (Maximum knee extension less than -15 degrees, Maximum ankle flexion less than 0 degree)"
2. Anaemia (Hg \< 10·0 g/dL)
3. Thrombocytopaenia (platelet count \< 100,000/mm3)
4. Severe heart disease (ischaemic heart disease, heart failure)
5. Severe Systemic organ failure ALT \<3·0× upper limit of normal Total bilirubin \< 1·5× upper limit of normal Serum creatinine \< 1·5× upper limit of normal
6. History of malignancy
7. Carriers of infectious disease: syphilis, HBV, HCV, HIV-1/HIV-2, HTLV-1, parvovirus B19
8. Pregnant or lactating or expecting to become pregnant during the study
9. Known serious allergy to any agents used in the study
10. Contraindication for magnetic resonance imaging
11. History of seizure within 2 years
12. Subject's body weight less than 45 kg for male and 40kg for female "13. Participating in another clinical trial within 90 days, or planning to participate in another clinical trial in the future"

14. Any condition that in the judgement of the investigator would place the patient at undue risk
Prevention of Postpartum Haemorrhage

Use of Tranexamic Acid for prevention of Postpartum hemorrhage in high risk patients: Randomized Control Trial

This study aims to assess the efficacy of administration of Tranexamic Acid in preventing Postpartum haemorrhage \& reducing intraoperative and postoperative blood loss in high risk women for Postpartum Hemorrhage undergoing caesarean section. Studying its benefit to transfusion-sparing and hysterectomy-sparing. \& reduction of hemorrhage-related mortality when Postpartum hemorrhage is expected.

Eligibility Criteria:
Inclusion Criteria:

* Women at high risk for postpartum hemorrhage after cesarean section

Exclusion Criteria:

* women who are not at high risk for postpartum hemorrhage , or attending for normal vaginal delivery.
Safety of Anal Curcumin

The purpose of this study is to see if curcumin can reverse anal high-grade squamous intraepithelial lesions (aHSIL) (high-grade anal precancerous cells or high-grade abnormal cells) in people living with HIV to avoid current treatments such as ablation (destroying abnormal cells with heat or surgical excision (cutting out the abnormal cells)), which have potential short- and long-term side effects.

This proposal suggests conducting a Phase I clinical trial using a 3 + 3 dose escalation approach to assess the safety and determine the maximum tolerated dose of intra-anal curcumin in individuals with HIV who have anal high-grade squamous intraepithelial lesions (aHSIL/AIN 2-3). Currently, there is a significant need for non-surgical treatments for pre-malignant anal diseases in people with HIV, aiming to reduce risks and complications associated with existing surgical and topical interventions.

Curcumin, a compound derived from turmeric, is known for its anti-inflammatory and anti-infectious properties. While previous research has shown its anticancer effects in oral doses, its bioavailability is limited, and intra-anal administration has not been studied in humans. This trial aims to explore the potential of intra-anal curcumin as an alternative treatment for aHSIL in people with HIV.

The study will involve enrolling participants with aHSIL and administering increasing doses of curcumin intra-anally for 14 days, following the 3 + 3 dose escalation model. The trial will continue until the dose-limiting toxicity (DLT) level is reached, and participants report symptoms necessitating a dose reduction.

To enhance future studies, the researchers will also evaluate patient and male partner acceptability through questionnaires. The insights gained from this trial will guide the design of subsequent efficacy and safety studies for individuals with AIN 2 and 3 neoplasia.

Eligibility Criteria:
Major Inclusion Criteria:

* 30 and older
* Have biopsy-proven anal intraepithelial neoplasia (AIN) 2, AIN 3 without previous treatment
* Or cytology results for ASC-H or HSIL
* Able and willing to complete Study Diary
* Other inclusion criteria apply

Exclusion Criteria:

* Have a clinically significant chronic medical condition that is considered progressive, such as but not limited to coronary disease, congestive heart failure, chronic obstructive lung disease, and diabetes mellitus. Chronic nonprogressive or intermittent syndromes are not excluded, including migraine headaches, mild reactive airway disease, controlled hypertension, stable pain syndromes, or benign gastric reflux.
* Have any history of anal cancer malignancy.
* Pregnant or planning to become pregnant in the next three months.
* Have a history of sensitivity or allergy to any compound used in this study.
* Have Grade 2 or higher renal or hematology abnormality,
* Are currently using, or in the last year have used intravenous drugs (except for therapeutic use), recreational drugs, or alcohol abuse.
* Other exclusion criteria apply
A Post-approval LAP-BAND® Lower Body Mass Index (LBMI) Study

This is a post-approval, multicenter, prospective, non-randomized, open-label, clinical study to evaluate the safety and effectiveness of the LAP-BAND® AP System in a lower obese population (BMI ≥ 30 kg/m2 and \< 40 kg/m2) with one or more obesity-related comorbidity up to 10 years after implantation.

The reason your study has been terminated is based on the availability of long-term safety and effectiveness data from the OSB Lead-HERo-002 study and published literature.

FDA post-approval study designed to collect prospective data in a real-world setting to evaluate long-term safety and effectiveness of the LAP BAND® System in patients with a BMI of ≥ 30 kg/m2 and \< 40 kg/m2 and one or more comorbid conditions. The Apollo-001 Study is a prospective, 10 year, multicenter study of patients who have decide to undergo implantation of the LAP-BAND AP® system. Outcomes include device explants, changes in weight, comorbid condition status, device- and procedure-related AEs, and reoperations.

The LBMI study was part of the condition of approval (CoA) for the Lap-Band device. It was terminated because it was no longer required to fulfill the condition of approval for the device. Apollo was able to fulfill the condition of approval (CoA) for the Lap-Band device by using data from published literature and another recently completed study (OSB Lead-Hero-002 study) which had long-term safety and effectiveness data addressing the conditions of approval.

Eligibility Criteria:
Inclusion Criteria:

1. LAP-BAND® System placed in a facility in the United States
2. BMI ≥ 30 kg/m2 and \< 40 kg/m2 prior to LAP-BAND® placement
3. Presence of 1 or more obesity-related comorbidities prior to LAP-BAND® placement
4. Aged 18 or older

Exclusion Criteria:

1. Prior bariatric surgery.
2. Participating in another ongoing clinical study in which concomitant diagnostic or therapeutic intervention that would reasonably be expected to alter patterns of care, use of medications or the outcomes under study.
3. Vulnerable patients or those unable to exercise free informed consent.
4. Inability to complete the questionnaires.
5. Patients who are addicted to alcohol and/or drugs.
A Study of Different Titration Schedules of ALKS 5461 in Adults With Major Depressive Disorder (MDD)

This is a Phase 3 study designed to evaluate the safety and tolerability of two titration schedules for ALKS 5461.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index of 18-40 kg/m2
* Have a diagnosis of MDD
* Have a current major depressive episode (MDE) lasting 8 weeks to 24 months
* Have been treated with an adequate dose of an approved antidepressant during the current MDE for at least 8 weeks
* Have an inadequate response to current antidepressant treatment
* Agree to use an approved method of birth control for the duration of the study
* Additional criteria may apply

Exclusion Criteria:

* Currently pregnant or breastfeeding
* History of or current infection with Hepatitis B Virus, Hepatitis C Virus or Human Immunodeficiency Virus (HIV)
* Have experienced hallucinations, delusions, or any psychotic symptoms in the current MDE
* Have used opioid agonists (eg, codeine, oxycodone, tramadol, or morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days
* Have received electroconvulsive therapy treatment within the last 5 years
* Have attempted suicide within the past 2 years
* Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone)
* Have had a significant blood loss or blood donation with 60 days of screening
* Additional criteria may apply
Intravenous Tranexamic Acid in Diabetic Macular TRD Surgeries

The goal of this observational study is to learn about safety and results of peroperative and intraoperative intravenous Tranexamic acid for diabetic macular tractional detachment eye surgeries . The main question it aims to answer is:

Adverse events and their frequency? immediate postoperative bleeding incidence? effective vitrectomy time?

all Patients who agreed and gave informed consent forsurgery as well as to be included in study were included

Patients injected INTRAVENOUS TRANEXAMIC ACID 500 mg diluted to 10 ml with normal saline slowly in immediate preoperative period Accordingly, whenever bleeding was anticipated before removing active taut membranes or when bleeder was noted TXA 0.5 g was added upto maximum of 2 g. In Chronic kidney Disease patients dose was kept as maximum of 1.5 g

data analysis pack of microsoft excel will be used for statistical analysis. descriptive statistics will be applied. wherever mean of continuous variables is to be compared among subgroups, unpaired students t test will be used. To find any relationship among continuous variables , pearsons correlation or multiple regression will be used from data analysis pack of microsoft excel.

Eligibility Criteria:
Inclusion Criteria:

* Eyes of Diabetic patients having Macular Tractional Retinal detachment confirmed on Indirect Ophthalmoscope or B scan when associated with Vitreous hemorrhage or Optical Coherence Tomography

Exclusion Criteria:

* Pregnancy, lactation, Oral Contraceptive use, within 6 months thromboembolic disease ,Underlying cardiac arrhythmia where anticoagulation is indicated ,Seizures Severe liver disease,previous history of variceal bleeding ,Allergic history to Tranexamic acid

Ophthalmic exclusion criteria Previous vitreoretinal surgery Combination of tractional and rhegmatogenous retinal detachment Coexisting macular hole Macular dystrophies Arterial or venous occlusions Age related macular degeneration Extensive macular scarring Posterior segment inflammation