cyrilzakka/clinical-trials huggingface dataset:
Effects of Music Therapy and White Noise on Pre-procedural Fear, Anxiety by Elderly Colonoscopy Patients

The aim of the study was to examine the effect of two different interventions (music therapy and white noise listening) on anxiety, fear and vital signs in elderly patients undergoing colonoscopy.

The study was a double-blind, pre-test and post-test

Colonoscopy patients experience high levels of fear and anxiety due to the procedure. Fear and anxiety can activate the patient's autonomic nervous system, leading to increased sweating, increased heart rate, blood pressure and respiratory rate, and procedure-related complications. Reducing fear and anxiety and relaxing the patient not only prevents potential harm to the patient due to the procedure, but also facilitates the work of the healthcare team performing the procedure and ensures accurate results. In this context, this study aimed to investigate the effects of music therapy and white noise listening on the fear, anxiety and vital signs of patients undergoing colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

1. The one to be colonoscoped,
2. 65 years of age or older,
3. Participated in the research voluntarily
4. No vision, hearing and perception problems,
5. No communication problems (able to speak Turkish),
6. Those who are hemodynamically stable before colonoscopy,
7. No psychiatric diagnosis, no use of antidepressants, anxiolytics and sedative agents,
8. No analgesic or anesthetic medication 24 hours before the procedure.

Exclusion Criteria:

1. Developing complications during the procedure,
2. Removing the headset during the procedure,
3. Participants with visual and hearing impairment or a medical history of dementia, cognitive impairments or psychiatric disorders
4. The general condition deteriorated during the procedure or a different intervention was performed with anesthesia,
5. Who wants to leave the study on their own accord.
HALOS: A Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Multiple Ascending Doses of ION582 in Participants With Angelman Syndrome

The purpose of this study is to evaluate the safety and tolerability of ascending doses of ION582 administered intrathecally in participants with Angelman syndrome.

This is a Phase 1-2a, open-label study consisting of 3 parts. Part 1 is a multiple ascending dose (MAD) study, consisting of a 13-week MAD Treatment Period and a minimum 12-week but up to 32-week Post-MAD Follow-Up Period. Part 2 is a multi-center 49-week study where participants who completed Part 1 will receive IT bolus doses of ION582 followed by a minimum 12-week Part 2 follow up period. Part 3 extends the treatment period for participants who completed Part 2 for up to an additional 3 years followed by a 32-week post-LTE follow up period. The study will enroll approximately 44, and up to 55, participants.

Eligibility Criteria:
Inclusion Criteria:

1. Participant has a documented and certified diagnosis of Angelman syndrome (AS) (ubiquitin-protein ligase E3A \[UBE3A\] deletion or UBE3A mutation)
2. Male or female between the ages of 2-50 years of age, with signed informed consent from parent(s) or legal guardian(s)
3. Currently receiving stable standard of care treatments such as, stable doses of anti-epileptic medication, behavioral management medications, sleep medications, gabapentin, cannabidiol, and including special diets, supplements or nutritional support for at least 3 months prior to first dose.
4. Follow good study practice and not participate in the sharing of personal or study information on social media platforms, such as any website or social media site (e.g., Facebook, Instagram, Twitter, YouTube, etc.) until notified that the study is completed.

Exclusion Criteria:

1. Has documented molecular AS confirmation of paternal uniparental disomy (UPD) or imprinting defect (ID).
2. Any clinically significant (CS) cardiovascular, endocrine, hepatic, renal, pulmonary, gastrointestinal, neurologic, malignant, metabolic, psychiatric, or other condition that, in the judgment of the Investigator, will pose a safety risk, will make the patient unsuitable for participation in, and/or unable to complete the study procedures. Has poorly controlled seizures as determined by the Investigator or has documented Status Epilepticus in the past 6 months that could pose a safety risk while on study.
3. Known bone, spine, bleeding, or other disorder that exposes the patient to risk of injury or unsuccessful lumbar puncture. Previous treatment with an oligonucleotide (including small interfering ribonucleic acid, antisense oligonucleotide \[ASOs\]). COVID-19 vaccinations are allowed.
4. Any prior use of gene therapy. Have any other conditions, which, in the opinion of the Investigator would make the participant unsuitable for inclusion or could interfere with the participant taking part in or completing the study.
Non-surgical Treatment of Peri-implant Mucositis: FMUD vs FMUD and Air-Flow Master Piezon®

The aim of the present study is to evaluate the adjunctive effect of glycine-powder air-polishing (GPAP) to full-mouth ultrasonic debridement (Fm-UD) in the treatment of peri-implant mucositis, and to determine the predictive role of implant and patient-level variables for disease resolution. Both treatments are described in the literature, but few studies are available on their comparison.

52 patients (132 implants) with peri-implant mucositis were included in this randomized parallel arm clinical study. Following baseline variables assessment, participants received Fm-UD. Implants allocated to the test group (n=64) were additionally treated with GPAP. Clinical outcomes were evaluated at 3 and 12 months following intervention. Complete and partial disease resolution were defined as absence of BoP (DR1) or \<2 BoP+ sites (DR2), respectively.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 70 years old;
* presence of one implant loaded at least one year before;
* bleeding on probing and/or suppuration of the peri-implant mucosa;
* pain and/or tenderness of the peri-implant mucosa;
* good general health conditions.

Exclusion Criteria:

* radiographic bone loss ≥ 2mm;
* intake of anticoagulants, antiplatelet, antibiotic or cortisone drugs;
* inability to perform oral hygiene maneuvers.
PSA Levels and Biopsy Samples After Implant Radiation and Hormone Therapy in Patients With Stage I or Stage II Prostate Cancer

RATIONALE: Studying samples of blood and tissue from patients with prostate cancer after receiving implant radiation therapy and luteinizing hormone-releasing hormone agonist may help doctors identify biomarkers related to cancer and help doctors predict how patients will respond to treatment.

PURPOSE: This laboratory study is looking at PSA levels and biopsy samples after undergoing implant radiation therapy and luteinizing hormone-releasing hormone agonist therapy in patients with stage I or stage II prostate cancer.

OBJECTIVES:

* To analyze biopsy results at 36 months after permanent iodine I 125 implantation therapy and luteinizing hormone-releasing hormone (LHRH) agonist therapy for patients with untreated intermediate-risk prostate cancer.

OUTLINE: Patients received luteinizing hormone releasing-hormone (LHRH) agonist therapy and permanent iodine I 125 implantation on protocol JUSMH-BRI-GU05-01.

Patients undergo blood sample collection and tissue biopsy for biomarker/laboratory analysis at 36 months after receiving brachytherapy and releasing-hormone agonist therapy. PSA levels and biopsy results are compared.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed prostate cancer

  * Previously untreated disease prior to participation on protocol JUSMH-BRI-GU05-01
* Intermediate-risk disease as defined by the following:

  * Clinical stage \< T2c
  * Prostate-specific antigen (PSA) ≤ 20 ng/mL
  * Gleason score \< 8
* Previously enrolled on protocol JUSMH-BRI-GU05-01

PATIENT CHARACTERISTICS:

* ECOG performance status 0-1
* Life expectancy ≥ 3 months
* WBC ≥ 2,000/μL
* Hemoglobin ≥ 10.0 g/dL
* Platelet count ≥ 100,000/μL
* Serum creatine level ≤ 2.0 mg/dL
* ALT and AST ≤ 100 IU/L
* No other cancer requiring treatment
* No poorly controlled hypertension (i.e., diastolic blood pressure ≥ 120 mm Hg)
* No severe psychiatric disorders, including schizophrenia or dementia
* No poorly controlled diabetes
* Considered appropriate for study participation, as determined by the Principal Investigator or Clinical Investigator

PRIOR CONCURRENT THERAPY:

* No prior drugs for benign prostatic hyperplasia (other than antiandrogen therapy)
* No prior surgery for prostate cancer
* No concurrent steroid drugs (except for ointment)
* No other concurrent antiandrogen therapy
Study on Benefits of Therapy With Nifurtimox in Chagas Disease, a Parasitic Illness Mostly Transmitted to Humans by a Bug, Using Information From Patient Medical Records in Argentina

The researchers in this trial want to analyze prerecorded patient data which provide information on benefits of the drug nifurtimox in patients with a sudden (acute) and long lasting (chronic) Chagas´ disease an illness caused by parasites mostly transmitted to humans by a bug. They also want to learn how often organs, especially the heart, are affected by the illness in treated and untreated chronic Chaga's patients. In order to find this out medical records of adult and pediatric patients in Argentina will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged ≥0 years at time of diagnosis with Chagas' disease
* Diagnosis of Chagas' disease confirmed by parasitological and/or serological method(s) before start of antitrypanosomal treatment or during the course of this antitrypanosomal treatment cycle for the first episode recorded.

Exclusion Criteria:

* Treatment with antitrypanosomal agent(s) other than nifurtimox, including experimental investigational products for Chagas' disease or antitrypanosomal combination treatment
* Patients with known evidence of organ manifestation of chronic Chagas' disease, e.g.Chagas' disease-related cardiomyopathy/heart disease, Chagas' disease-related digestive disease at time of primary diagnosis.
Multilevel Intervention for Precision Oncology

The investigators are rolling out a 3 level intervention designed to improve the use of Precision Oncology at 8 VA medical centers. The 3 components of the intervention are 1: a short educational video for patients, 2: audit and feedback to providers on their Precision Oncology practice patterns, and 3: a change in the electronic medical record to make it easier to order and review results of Precision Oncology tests.

Background: Precision oncology (PO), the use of molecular testing to identify tumor specific abnormalities which facilitate targeted therapy, is proven to extend lives and improve quality of life for patients with cancer. Extensive study, however, documents that up to 50% of patients in the VA, especially those with adverse social determinants of health (older age, rural), do not receive guideline recommended PO.

Methodology: Building on our previous analyses, and the Theoretical Domains Framework, we designed a mixed-methods type I hybrid effectiveness-implementation study of a multilevel intervention (MLI) to improve the use of PO. The MLI will be instituted for veterans with advanced cancers of the colon, lung, and prostate, as well as providers at 8 sites, chosen to represent diversity at the level of rurality, geographic region, cancer volume, and mode of delivery (virtual/in-person). The patient intervention is a 5-minute educational module accessible by QR code. The provider intervention is a 45-minute academic detailing session, as well as individualized audit and feedback on practice patterns. The facility level intervention is a previously piloted integration of PO ordering, interdepartmental communication, and results return into the primary electronic medical record via a consult function. The primary efficacy outcome is the rate of molecular testing/eligible veterans. Validated survey measures will be used for stakeholder engagement. The process evaluation employs a mixed methods approach based in the RE-AIM framework, which includes quantitative analyses of collected data, and interviews of patients and providers. The statistical design is a randomized stepped-wedge trial over 3 years which retains control data from across all sites.

Eligibility Criteria:
Inclusion Criteria:

* Patients in the VA with cancer of the lung or prostate who are seen in the oncology clinic

Exclusion Criteria:

* Cancer that did not originate in the prostate or the lung
A Clinical Study to Evaluate CAR-T Cell-based Medicinal Product in the Treatment of Advanced Solid Tumors

This is a prospective, single-arm, open-label Phase 1 dose-finding and expansion study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy profiles of the cell-based LCAR-C18S (hereinafter "LCAR-C18S") in subjects with Claudin18.2-positive advanced solid Tumors.

This is a prospective, single-arm, open-label Phase 1 dose-finding and expansion study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy profiles of the cell-based LCAR-C18S (hereinafter "LCAR-C18S") in subjects with Claudin18.2-positive advanced solid Tumors. Patients who meet the eligibility criteria will receive LCAR-C18S infusion. The study will include the following sequential phases: screening, pre-treatment , treatment and follow up

Eligibility Criteria:
Inclusion Criteria:

1. The subjects have been fully informed of the possible risks and benefits of participating in the study and have signed the informed consent form;
2. Age 18-70 years;
3. Immunohistochemistry of tumor tissue samples indicates Claudin18.2 positive ;
4. Recurrent or metastatic advanced solid tumors (including advanced gastric cancers and non-gastric cancers) and have been failed to prior lines of systemic treatment
5. According to the RECIST v1.1, at least one measuable tumor lesion;
6. ECOG performance status score of 0-1;
7. Expected survival ≥ 3 months;
8. Subjects should have adequate organ functions before screening and treatment.
9. Women of childbearing age must have a negative blood pregnancy test; subjects of childbearing potential must use effective contraception for ≥ 1 year after the final study treatment.

Exclusion Criteria:

1. Previous CAR-T cell therapy or other cell therapies or therapeutic tumor vaccination against any target;
2. Any previous therapy targeting Claudin18.2;
3. Prior antitumor therapy with insufficient washout period;
4. Pregnant or lactating women;
5. Brain metastases with central nervous system symptoms;
6. Uncontrolled diabetes;
7. Oxygen is required to maintain adequate blood oxygen saturation;
8. Gastric perforation, pyloric obstruction, complete biliary obstruction, complete or incomplete intestinal obstruction requiring clinical intervention, or pleural effusion or peritoneal effusion requiring clinical intervention;
9. Clinically significant liver disorders (including liver cirrhosis, active viral hepatitis or other hepatitis);
10. HIV, Treponema pallidum or HCV serologically positive;
11. Severe underlying disease
12. New York Heart Association (NYHA) Class III or IV congestive heart failure or left ventricular ejection fraction (LVEF) \< 50%; unstable angina, myocardial infarction or coronary artery bypass grafting (CABG) in the past 6 months; history of severe non-ischemic cardiomyopathy; or severe uncontrolled arrhythmia;
13. Any condition that, in the opinion of the investigator, will make the subject unsuitable for participation in this study.
Effect of Acupuncture on Patients With Mild Hypertension

This is a large scale, open-label, multicenter, randomized controlled clinical trial with four parallel arms. This trial aims to evaluate the effectiveness of affected meridian acupuncture for patients with mild hypertension,with respect to decreasing their blood pressure, safety of acupuncture ,and improving their quality of life as well.

Investigators plan to recruit 428 hypertensive patients. Eligible patients will be randomized to four different groups.ⅰ. the affected meridian acupuncture group (AMA, n=107) will be treated with acupoints on affected meridians.ⅱ.the non-affected meridian acupuncture group (NMA, n=107) will be treated with acupoints on non-affected meridians.ⅲ.invasive sham acupuncture group(ISA, n=107)will be provided with sham acupoints treatment.ⅳ.waiting-list group(WL, n=107)will not be given any intervention.

Eligibility Criteria:
Inclusion Criteria：

1. Patients whose age between 40 and 75 years old, male and female;
2. Patients who meet the diagnostic criteria of mild hypertension according to JNC-7 and China's prevention and cure guide of hypertension. mild hypertension (WHO/ISH criteria stage I) Systolic blood pressure 159≥(SBP) ≥140 and/or diastolic blood pressure 99≥(DBP) ≥90 .
3. Patients who are initially diagnosed as mild hypertension or have been diagnosed as mild hypertension before but have not taken any antihypertensive drugs.
4. Patients who are diagnosed as yue-yin style (yin-deficiency accompany with hyperactivity of yang) or yang-ming style (obstruction of phlegm and dampness) according to meridian syndrome differentiation
5. Patients who have a good understanding of our study. and willing to comply with our study protocol.
6. Informed consent form must be signed by patient or lineal relative.
7. All the tips are matched will be included.

Exclusion Criteria:

1. Patients who have been diagnosed as secondary hypertension or malignant hypertension(e.g. Cushing's syndrome, coarctation of the aorta，phaeochromocytoma, renal parenchymal disease，primary aldosteronism， renovascular hypertension, obstructive sleep apnoea，drug induced hypertension et al )
2. Patients who accompany with other severe medical conditions (e.g. endocrine disorders, cardiovascular disease. Digestive disease. hepatic dysfunction，cerebral vascular disease. renal disease. haematologic disease et al). Who may be not safe to join our study.
3. Patients with a chronic disease which might not suitable for our study. e.g: epilepsy ,severe depression or anxiety (SAS≥70,SDS≥70) ,psychosis, allergic constitution, accompany with any infection.
4. Pregnant women or women in lactation or women of child bearing potential plan to conceive in the recent six months.
5. Patients who currently participate in another clinical trial.
6. Patients who Had been treated with acupuncture during the previous three months
7. If one of the tips mentioned above is matched will be excluded.
ED50 and ED95 of Remifentanil for Intubation Without NOL Variation

Our aim, in this study, is to elucidate the optimal dosing range (ED50 and ED95) of bolus remifentanil in order to counter the painful stimuli resulting from direct laryngoscopy and tracheal intubation by using the NOL index. In order to maximize the clinical relevance of our findings, induction of general anesthesia will be done with standard medications and doses and laryngoscopy will be done with the Macintosh laryngoscope, the most common tool used for intubation in the operating room

Background: There are no study so far that determined the ED50 and ED95 of remifentanil to perform tracheal intubation by using the NOL index as the criterion measured to determine the failure (painful intubation) or the success (pain free intubation) of the assessed procedure.

Objectives: To determine the ED50 and ED95 of remifentanil bolus to perform tracheal intubation without NOL index variating over threshold for nociceptive response (determined as a NOL index going over 20 - peak value of maximum 20) using the Macintosh blade when obtaining good conditions of intubation in anesthetized patients. Good conditions of intubation will be determined as obtaining a Cormack-Lehane grade I and II.

Eligibility Criteria:
Inclusion Criteria:

* ASA status I or II
* Mallampati class I or II
* Patients \> 18 years old and \<65 years (defining elderly patients)
* Elective general, gynecological, orthopedic, plastic or urological surgery under general anesthesia
* Type of surgery that usually necessitate endotracheal intubation and controlled ventilation

Exclusion Criteria:

* Patient refusal
* History of psychiatric diseases or psychological problems (including mental retardation); inability to give consent; language barrier.
* Anticipated difficult airway (Mallampati class III and IV, thyromental distance \< 6 cm, mouth opening \< 3 cm, neck extension \<80° and neck flexion \<35°, inability to prognath, meaning bringing lower mandibular before the upper maxilla)
* Patient with history of neck rigidity or instability
* BMI \> 30 kg/m2
* Anticipated difficult ventilation (patients with beard, obesity with BMI more than 30 kg/m2)
* Patient with history of oropharyngeal or tracheal surgery (excluding adenoidectomy, tonsillectomy and teeth removal)
* Severe coronary artery disease
* Serious cardiac arrhythmias (including atrial fibrillation)
* Use of β-blockers (all types)
* History of opioid or illicit drug substance abuse
* Chronic use of psychotropic and/or opioid drugs
* Allergy to remifentanil or propofol
* Pregnancy
* Contraindications to mask ventilation (gastrointestinal tract obstruction, pregnancy, active not-treated gastroesophageal reflux disease, non-fasting patients)
* Unexpected difficult airway requesting excessive, possibly painful airway manipulations
* Requiring hemodynamic support with vasopressors or inotropes 2 min before laryngoscopy to 5 min after insertion of endotracheal tube
Does Fish Oil Prevent Depression in Pregnancy and Postpartum?

This study is designed to test whether an alternative medicine treatment, fish oil, will prevent depressive symptoms in pregnant and postpartum women who have been found to be at risk for depression. Epidemiologists have observed that people who live in countries where people on average eat a diet high in fish have a lower risk of depression than people who live in populations that eat less fish. Postpartum depression is also less common in these countries. The omega-3 fatty acids found in fish oil are thought to be responsible for this beneficial effect of eating fish. The two major omega-3 fatty acids found in fish are eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). DHA is an essential building block of the brain and nerve tissue. EPA may act to optimize the electrical signals between nerve cells and brain cells and may help the immune system to function well.

Some researchers have treated people who are already suffering from depression with fish oil. Some of these studies have shown a benefit for the fish oil treatment and others have not. These studies have tested EPA and DHA alone and in various combinations. Currently, it is not known whether EPA or DHA is more effective in preventing and treating depression. Some of the researchers involved in this study have learned how to identify mothers who are most at risk for developing depression during and after pregnancy. This study is designed to learn whether EPA-rich and DHA-rich fish oil supplements will prevent depressive symptoms in women who are at risk to develop depression.


Eligibility Criteria:
Inclusion Criteria:

* Women who are more than 12 weeks pregnant but less than 20 weeks pregnant
* Women who are found to be at risk for depression
* Women who have been treated for depression in the past
* Women with depression after a previous pregnancy
* Women planning to deliver at University of Michigan Hospital

Exclusion Criteria:

* Women who have major depression or other psychiatric disorders (current substance abuse, schizophrenia, bipolar disorder) at the time of screening
* Women who are currently taking anti-depressant or other psychiatric medications
* Women who routinely eat more than 2 fish meals per week
* Women on anticoagulants (blood thinners)
* Women currently taking omega-3 fatty acid dietary supplements (fish oil, flaxseed oil or cod liver oil)
* Women with bleeding disorders such as von Willebrand's disease
* Women under the age of 18
* Women with a multiple gestation (twins, for example)
* Women planning to deliver at another hospital
* Women planning to move away before 6 weeks after delivery