cyrilzakka/clinical-trials huggingface dataset:
Family-centered Mental Health Promotion Intervention

Goal: The long-term goal of the proposed research program is to test the effectiveness of a preventative behavioral intervention and to scale it up for use with broader immigrant populations to reduce stress and mental health disorders.

Intervention: This study plan to adapt the World Health Organization developed Problem Management Plus (PMP), an evidence based, multi-component, behavioral intervention including breathing, problem solving, behavioral activation, and social support for immigrants.

Hypothesis: Immigrants in the Problem Management Plus for Immigrants (PMP-I) will have significantly lower levels of stress and anxious/depressive symptoms as compared to immigrants in the talk program with Community Support Service pamphlets (CSS).

Objective: The current study aims to pilot test the feasibility and acceptability of PMP-I among Bhutanese immigrants 18 years and older living in the Massachusetts.

Problem Management Plus (PMP) is a low-intensity evidence-based psychological intervention developed by World Health Organization that can be delivered by trained lay people. PMP systematically teaches four strategies: stress management through breathing exercises, problem solving, behavioral activation, and skills to strengthen social support at individual level. The current study plans to adapt PMP to develop the PMP for Immigrants (PMP-I) for a family setting to address immigrant's multiple social and emotional stressors while adjusting into the new multi-cultural environment of the United States. The rationale to adapt PMP is based on our intervention model that demands integration of social and emotional stressors; promising results of PMP; strong evidence of family and community ties in health care process; and growing consensus among community, scientists, and policymakers on the need for family-based care models that are sustainable. PMP-I is a 5-week, peer-led, culturally tailored mental health promotion program that includes psychoeducation, behavioral activation, and problem solving (90 minutes/session/weekly), and breathing exercises and yoga (90 minutes/session/weekly) in a family setting. Participating families will be randomly allocated into two groups (N=116 families (232 participants: two eligible members per family); 58 families per intervention (PMP-I) and control (CSS)) with assessments at baseline, post-intervention, and 3-month post-intervention with trained community facilitators in collaboration with church leaders.

Eligibility Criteria:
Inclusion Criteria:

* Bhutanese adult 18 years or older resettled in Massachusetts
* Have a score of 14 or below on the Patient Health Questionnaire (PHQ-9)

Exclusion Criteria:

* Have a PHQ-9 score of 15 or above
* Clinically diagnosed mental health disorders
* Taking psychiatric medications for any mental health problems
Effect of Clear Aligner Attachment Design on Extrusion of Maxillary Lateral Incisors

The purpose of this research is to test which of four clear aligner attachment types is more efficient in extruding (erupting) maxillary lateral incisors vertically into correct position during orthodontic treatment.

Attachments are small tooth-colored shapes that are bonded (attached) to teeth before or during treatment with clear aligners. They are like handles, giving aligners something to gently push teeth into correct positions. There are 4 different shapes of attachments that are commonly used to extrude lateral incisors (incisally-beveled, gingivally-beveled, optimized and horizontal). All 4 of these attachments are successful in extruding lateral incisors but there is not enough research evidence to know for sure which attachment would be ideal for a specific circumstance.

Eligibility Criteria:
Inclusion Criteria:

1. Patients 16 years or older to be treated with either Comprehensive Invisalign or Invisalign Teen,
2. Maxillary lateral incisor requiring 0.3 mm or more extrusion (as determined by ClinCheck),
3. Maxillary arch with less than 6 mm of crowding or spacing,
4. All teeth present and fully erupted (excluding third molars).

Exclusion Criteria:

1. Presence of anterior crossbite
2. Any missing teeth in the maxillary arch
3. Treatment plan includes surgery or extraction of any maxillary teeth,
4. Maxillary lateral incisors with pathology or large restorations (crowns)
5. Maxillary lateral incisors have a less than 0.3 mm of extrusion prescribed in the Tooth Movement Table on the Invisalign ClinCheck
Chiglitazar/Metformin in Non-obese Women With PCOS

Polycystic ovary syndrome (PCOS) is the most common endocrine and metabolic disorders in women of reproductive age, and its prevalence rate is from 9% (NIH criteria) to 18% (Rotterdamcriteria). It is clinically characterized by hyperandrogenism, persistent anovulation, and polycystic ovarian changes. Moreover it is often accompanied by insulin resistance and obesity. Now, metformin is not only an antihyperglycemic drug, it also corrects insulin resistance and hyperandrogenism in polycystic ovary syndrome. Chiglitazar is a novel peroxisome proliferation activated receptor (PPAR) agonist. Treatment of type 2 diabetes mellitus by moderate activation of PPARα, PPARγ and PPARδ, improving insulin sensitivity, regulating blood glucose, and promoting fatty acid oxidation and utilization. However, there is limited evidence for its treatment of insulin resistance in women with PCOS. Therefore, investigators applied chiglitazar and metformin to two groups of PCOS patients to understand their effects on insulin resistance.


Eligibility Criteria:
Inclusion Criteria:

1. Female aged 18- 45 years old
2. Normal weight BMI 18.5--24
3. Diagnosis of hyperandrogenism T\>0.481ng/ml
4. The diagnosis of PCOS is based on the diagnostic criteria established by the Rotterdam consensus
5. No use of drugs affecting reproductive endocrine in the 3 months prior to the clinic visit

Exclusion Criteria:

1. T level is within the normal range
2. Organ dysfunction
3. Drugs that can affect endocrine such as contraceptives and steroids taken in the past 3 months
4. Confirmed diagnosis of diabetes
5. Are on a diet, use weight-affecting medications, or have experienced a weight change of \>4.5kg within 3 months prior to the start of the study
6. Have other endocrine disorders, such as thyroid dysfunction, adrenal gland disease, hyperprolactinemia, etc.
7. Combined psychiatric disorders and severe primary diseases
8. Allergy to the drug or components of this study
9. Those who do not follow the doctor's instructions during the medication, or discontinue the treatment due to serious adverse reactions
Attenuation of Hemodynamic Response to Laryngoscopy and Endotracheal Intubation With Single Dose of Dexmedetomidine in Hypertensive Patients.

Attenuation of Hemodynamic Response to Laryngoscopy and Endotracheal Intubation With Single Dose of Dexmedetomidine in Hypertensive Patients.


Eligibility Criteria:
Inclusion Criteria:

* - Age group 20-60 years
* ASA grade 1 and 2
* control hypertensive patients.

Exclusion Criteria:

* - Consent not given
* ASA Grade 3 and 4
* history of myocardial ischemia or infarction, or had an abnormal ECG on admission to the hospital
* Patients with cardiovascular, pulmonary, hepatic, and renal disease.
* Patients on B blockers.
* patients with difficult airway; laryngoscopy and intubation time more than 20 s, or requiring more than two attempts will be exclude from the study.
Efficacy and Safety of Nexpowder™ for Non-variceal, Upper Gastrointestinal Bleeding

The purpose of this pilot clinical trial is to confirm the efficacy and safety of Nexpowder™ for hemostasis in pilot cohort of patients with NVUGIB in Singapore

24 subjects with non variceal bleeding will be enrolled. The efficacy and safety of Nexpowder™ as primary technique of endoscopci hemostasis will be assessed in this pi,ot study.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females aged over 21 to 75 years
2. Patients with confirmed nonvariceal, upper gastrointestinal bleeding
3. Patients who voluntarily agree to the clinical trial with informed consent
4. Patients who willing and able to comply with the study protocol

Exclusion Criteria:

1. Patients with an uncorrected coagulation disorder (PLT\<50\*109/L, INR\>2)
2. Patients who are known to be pregnant or in lactation
3. Patients who have received another endoscopic treatment for the same part of the body within the days preceding the study
4. Patients for whom endoscopic treatment is prohibited due to comorbidity
5. Patients for whom the 30-day follow-up period is impossible
6. Patients who have participated within the past month in other related clinical trials that could affect the results of the study
7. Other cases in which participation in the study is judged inappropriate by the investigators
Drug-Drug Interaction Study to Evaluate the Effect of Inhibition of UGTs on the PK of Ecopipam and Its Active Metabolite

This is a single center, open-label, fixed sequence, drug-drug interaction (DDI) study in healthy subjects.

Following a 28-day Screening period, eligible subjects will enter the clinical research unit (CRU) and will be enrolled into either Cohort A or B. Subjects in both cohorts will receive a single dose of ecopipam on Day 1. On Day 7, subjects will begin taking a UGT inhibitor according to their assigned cohort. Subjects in Cohort A will receive mefenamic acid 250 mg every 6 hours for 7 days, while subjects in Cohort B will receive divalproex sodium ER 1250 mg once a day for 10 days. A single oral dose of ecopipam will also be administered to Cohort A on Day 7, 1 hour after the first dose of mefenamic acid, and to Cohort B on Day 10, 1 hour after administration of divalproex sodium ER. Subjects in Cohort A will continue taking mefenamic acid through the evening of Day 13 and will remain in the CRU until discharged on Day 14/ET. Subjects in Cohort B will continue taking divalproex sodium ER through Day 16 and will remain in the CRU until discharge on Day 17/ET.

Eligibility Criteria:
Inclusion Criteria:

* Male subjects or female subjects of non-childbearing potential
* ≥18 and ≤55 years of age at the time of consent
* BMI \>18.5 and \<30 kg/m2 and a weight of ≥50 kg
* Sexually active males must use a double barrier method of contraception during the study and for at least 90 days after the last dose of study drug
* Male subjects must be willing not to donate sperm until 90 days following the last study drug administration

Exclusion Criteria:

* Personal or family History of significant medical illness
* Clinically significant abnormalities on screening tests/exams
* History of or significant risk of committing suicide
* Donation of plasma within 7 days prior to dosing
* Donation or significant loss of blood within 30 days prior to the first dosing
* Major surgery within 3 months or minor surgery within 1 month prior to admission
* Use of prohibited prescription, over-the-counter medications or natural health products
* Alcohol-based products 24 hours prior to admission
* Female subjects who are currently pregnant or lactating
* Use of tobacco or nicotine products within 3 months prior to Screening
* Significant alcohol consumption
* History of drug abuse within the previous 2 years, or a positive drug screen
* History of allergy to study medications
* Not suitable for study in the opinion of the Principal Investigator
Extended Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome

The objective of this study is to verify the relationship between coronary plaque regression and cardiovascular prevention in long term follow up of the Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome (JAPAN-ACS) study \[NCT00242944\]. In addition, the effect of serum lipid levels or different type of statins on cardiovascular prevention will also be examined.

Several previous multicenter studies using intravascular ultrasound (IVUS) imaging have revealed that statins attenuate the progression of atherosclerosis or even provide regression of plaque volume. Indeed, the Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome (JAPAN-ACS) trial \[NCT00242944\] has revealed that early aggressive statin therapy in patients with acute coronary syndrome (ACS) significantly reduces the plaque volume of non-culprit coronary lesions On the other hands, a direct relationship between atheroma progression and regression on IVUS and clinical events has not been clearly defined. To verify that relationship, long term follow up of the JAPAN-ACS study will be performed. Clinical outcome of patients with regressed plaque and progressed plaque will be compared. In addition, the objectives of this study are to evaluate the effect of serum lipid levels or different type of statins on cardiovascular prevention.

Eligibility Criteria:
At the enrollment of original study

Inclusion Criteria:

* Patients with written consent by their own volition after being provided sufficient explanation for their participation in this clinical trial
* Patients 20 years or older at the time of their consent
* Patients with hypercholesterolemia as defined by any of the following criteria:

TC \>= 220 mg/dL; LDL-C \>= 140 mg/dL; Cholesterol-lowering treatment is necessary in accordance with the investigator's judgement when LDL-C \>= 100 mg/dL or TC \>= 180 mg/dL.

* Patients who have been diagnosed with acute coronary syndrome
* Patients with successful percutaneous coronary intervention (PCI) by intravascular ultrasound (IVUS) guidance
* Patients having coronary plaques (\>= 500 µm in thickness or 20% or more in % plaque) at \>= 5 mm from the previously treated area in the same branch of coronary artery

Exclusion Criteria:

* Patients with bypass graft or in-stent restenosis at the site of PCI
* Patients who had received PCI on the lesion in the past where the evaluation of coronary plaque volume is planned
* Patients who had plaques in a non-culprit site and might receive PCI during the treatment period
* Patients receiving lipid-lowering drugs (statins, fibrates, probucol, nicotinic acid or cholesterol absorption inhibitors)
* Patients with familial hypercholesterolemia
* Patients with cardiogenic shock
* Patients receiving cyclosporine
* Patients with any allergy to pitavastatin or atorvastatin
* Patients with hepatobiliary disorders
* Pregnant women, women suspected of being pregnant, or lactating women
* Patients with renal disorders or undergoing dialysis
* Patients who are ineligible in the opinion of the investigator
Commercially Available Cannabis Products for Immune Support

This study will be a prospective observation of the use of commercially available hemp and cannabis products marketed for immune support.

In the era of COVID-19, there has been much speculation about the risks and benefits of cannabis use for immune support. It is well known that the endocannabinoid system plays a role in the regulation of the immune response and its role in inflammation reduction may be useful in terms of a potential adjunctive therapy for acute infection. Cannabis products vary widely in their composition and may have a varying effect based on the strain and the associated terpenes. Here, we aim to track cannabis and hemp usage during an acute infection to understand it's safety and effects in a symptomatic population.

Given the fast and widespread acceptance and use of cannabis products in the US market, commercial use has outpaced randomized controlled trials (RCTs). Thus, carefully designed observational studies are important to understand how these products are affecting consumers. Prospective observational designs allow for real-world examinations of commercialized products with similar effect sizes to RCTs. Although observational designs have some drawbacks, a review covering 1,583 meta-analyses across 228 medical conditions compared the effect sizes from RCTs with those from observational studies for the same medical conditions and found no differences between the two. (1) These data provide evidence that a carefully designed observational study can help us better understand the effects of commonly used products such as cannabis edibles. The aim of this observational study is to evaluate the safety and associated effects of commercially available cannabis products in the US in symptomatic individuals seeking them for immune support.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Able to read and write in English
3. Active participants in the Pennsylvania medical marijuana program (for cannabis product users)
4. Currently experiencing one or more of the following symptoms due to an acute illness:

   1. Fever or chills
   2. Cough
   3. Fatigue
   4. Muscle or body aches
   5. Headache
   6. Sore throat
   7. Congestion or runny nose
   8. Nausea or Vomiting
   9. Diarrhea
5. Agrees to consume their chosen hemp or cannabis product (for the cannabis arm) and to not use a different hemp or cannabis product through the duration of the study
6. Agrees to continue to abstain from using hemp or cannabis (for the non-cannabis/hemp using arm)
7. Must have smart phone or email and access to the internet
8. Be able to comply with study requirements including baseline, completion of electronic questionnaires, and study timeline parameters.

Exclusion Criteria:

1. Women who are pregnant, breastfeeding, or planning to become pregnant.
2. Known allergy to any compounds in hemp or cannabis.
3. Endorses suicidal intent
4. Immunocompromised individuals
5. Unwilling or unable to comply with study procedures
6. Terminal Illness with life expectancy less than 1 year
Insertion Depth Comparison of Tracheal Tubes

There will be a difference of the insertion depth between the types of the endotracheal tube.


Eligibility Criteria:
Inclusion Criteria:

* undergoing surgery under general anesthesia -

Exclusion Criteria:

* upper airway or pulmonary problems
* neck and/or chest distortion
* patients at risk for pulmonary aspiration of gastric content -
Early Access Program With Arimoclomol in US Patients With NPC

NPC is a rare, relentlessly progressive, neurological disease and associated with serious morbidity and shortened life expectancy.

The purpose of this Expanded Access Program is to provide early access to arimoclomol for patients with Niemann-Pick Type C disease who, in the opinion and the clinical judgement of the treating physician, may benefit from treatment with arimoclomol.

Participants will receive treatment with arimoclomol until their doctor finds it does not help them anymore, they withdraw, or the study is stopped for any reason.


Eligibility Criteria:
Inclusion Criteria:

* The patient has a confirmed diagnosis of NPC (NPC1 or NPC2)\* and at least one neurological symptom.
* The patient is two years of age or above.
* The patient is a permanent resident of US.
* If taking miglustat (Zavesca®), the patient must have been on the target dose for the past six weeks.
* If the patient is a sexually active female of child-bearing potential (post-menarche), it is agreed to use highly effective contraception during the EAP and until three weeks after the last dose of arimoclomol.
* Confirmed negative urine pregnancy test for sexually active female of child-bearing potential (post-menarche).
* All sexually active male patients with female partners of child-bearing potential (postmenarche) agree to use a condom in addition to the birth control used by their partners during treatment and until three weeks after the last dose of arimoclomol.
* If the patient has a history of seizures, the condition must be adequately controlled, i.e., the pattern of seizure activity must be stable, and the patient must be on a stable dose and regimen of antiepileptic medication during one month prior to screening.
* Patient or parent/guardian must provide written informed consent to participate in EAP.

  * In line with Patterson et al. 2017

Exclusion Criteria:

* Severe liver insufficiency.
* Renal insufficiency.
* The patient has a known or suspected allergy or intolerance to arimoclomol or its constituents.
* The patient is pregnant, planning to become pregnant (while on the EAP program) or is currently breastfeeding.
* The patient will undergo treatment with another investigational drug\*, whilst participating in the program or in the 4 weeks prior to commencing treatment with arimoclomol.
* The patient is either eligible and able to participate in or is currently participating in an active interventional clinical trial within the indication.
* The patient, in the opinion of the clinician, is unable to comply with the treatment or has a medical condition that would potentially increase the risk to the patient by participation.
* The patient has a medical condition which hinders the clinician's assessment of arimoclomol safety and efficacy (e.g. certain epileptic conditions or severe cataplexy).

  * Including unlicensed product provided under an Early Access Program or equivalent compassionate use programs
EFFICIENCY OF HEMOVIGILANCE MODULE TRAININGS GIVEN TO NURSES

The aim of the present study is to determine the effectiveness of hemovigilance module training given to nurses.

125 nurses from the clinic and intensive care units, who received the most intensive blood transfusion from two different hospitals, were included in the study as the intervention and control groups. The control group was not trained. Only the pretest was administered one week after the posttest. After the pre-test was applied to the nurses in the intervention group, five modules of training, which lasted four hours, were given using interactive methods. Five modules of training were prepared by the researcher. These five modules are the 1st module of training; definition of hemovigilance, its aims, the development of hemovigilance in the world and in Turkey, and legal legislation, Module 2; Donor selection, Blood donation Process, Phlebotomy and Donor reactions, Module 3; blood, blood transfusion, its purpose, properties of blood and blood components, Blood transfusion process, Module 4; acute and delayed transfusion reactions and management, Module 5; It consists of the national hemovigilance system, the organization of the hemovigilance system at the hospital level, Traceability, Trace-back from the Patient to the Donor, and Look-back from the Donor to the Patient. the training was over, the final test was administered. One month later, this test was repeated.

Eligibility Criteria:
Inclusion Criteria:

She/He voluntarily agrees to participate in the research, Working as a nurse in the clinic and intensive care unit where blood transfusions are the most, Working for at least 6 months,

Exclusion Criteria:

Nurses working in the emergency and operating rooms, in clinics where blood transfusion is not performed the most, Being a new nurse, On maternity leave and maternity leave, Having an external assignment, Nurses working in the polyclinic,