cyrilzakka/clinical-trials huggingface dataset:
PBM or Dry Float Therapy on Sleep Quality in Middle-aged and Elderly

The main objective of this study is to assess the impact of implementing photobiomodulation (PBM) therapy, either localized or whole body, or dry float on sleep quality in middle-aged and elderly individuals experiencing sleep disturbance. As a secondary objective we will analyze the effect of the treatments on other indices of recovery (subjective and objective) via physiological monitoring in middle-aged and elderly individuals experiencing sleep disturbance.

The study will have 2 phases: Phase 1 will last 5 weeks and will serve as baseline data collection of sleep quality. Phase 2 contains the experimental conditions and will last 13 weeks. Cognitive, behavioral, and physiological tests will be done at baseline (week 1) and at the end of experimental period (week 18). Sleep tracking data will be collected daily.

In summary the study participants are expected to:

* Wear a study provided smart ring (OURA Ring) through the end of the study period (at least 75% of the total study time) which measures sleep quantity/quality.
* Keep their smart phones nearby and charged while wearing their devices.
* Complete monthly surveys with questions about general well-being until the end of the study period.
* Complete a testing battery consisting of cognitive tests, behavioral and mood questionnaires, qEEG and physical assessments, in the beginning and at the end of the study period.
* Complete the designated experimental condition 2- 3x/week for 12 weeks (at least 75% of the total sessions), if applicable.

Eligibility Criteria:
Inclusion Criteria:

* Male or female between 50-85 years of age
* Able and willing to give informed consent
* No significant untreated medical history

Exclusion Criteria:

* Have no mental or physical conditions that are deemed inappropriate for study participation at investigator's discretion.
Interaction Between Cocaine and Quetiapine - 1

The purpose of this study is to assess the safety of intravenous (IV) cocaine in subjects taking quetiapine at 3 dosage levels.

A placebo-controlled, double-blind, inpatient assessment of interaction between intravenous cocaine and quetiapine (seroquel) in cocaine-experienced subjects. To assess the safety of IV cocaine in subjects taking quetiapine at 3 dosage levels.

Eligibility Criteria:
Inclusion Criteria:

Includes but is not limited to: non-treatment seeking individuals. Must meet DSM-IV criteria for cocaine abuse or dependence. Must be able to verbalize understanding of consent and provide written informed consent and verbalize willingness to complete study procedures. Site will provide further details.

Exclusion Criteria:

Please contact site for further information
Innovating CBT-I for Cancer Survivors: An Optimization Trial

The overall goal of this project is to conduct a factorial, randomized controlled trial to optimize synchronous, virtual delivery of CBT-I for cancer survivors. The proposed project will yield multiple deliverables to innovate cancer survivorship care, chiefly an optimized, scalable, virtually-delivered intervention that addresses chronic insomnia, one of the most deleterious concerns among the growing demographic of cancer survivors in the U.S. Findings will inform future considerations for delivering CBT-I to cancer survivors.

Insomnia is a significant issue in 30-50% of cancer survivors. Our pilot randomized controlled trial of synchronous, virtual cognitive behavioral therapy for insomnia (CBT-I) for cancer survivors suggested that a group format or booster sessions may optimize effects on insomnia and daytime functioning. The goal of this project is to conduct a factorial, randomized controlled trial to optimize synchronous, virtual delivery of CBT-I for cancer survivors. We will conduct a 2×2 factorial trial (N=80) to evaluate the optimal combination of two intervention design components: delivery (individual vs. group) and booster sessions (0 vs 3). The primary outcome is change in insomnia severity (insomnia severity index) from T0 (week 0) to T2 (week 8). The secondary outcomes are acute (T0-T1, week 4) and sustained (T0-T3, week 16) changes in insomnia severity, emotional distress, work-related functioning, use of sleep medications, and subjective and objective sleep metrics (measured with sleep diaries and Fitbit). Exploratory aim 1 is to characterize study participation and sleep outcomes among cancer survivors with insomnia. Exploratory aim 2 is to characterize the acceptability of design components using Likert ratings (very low=1 to very high=5, benchmarks=4 or higher) and exit interviews with open-ended responses with probes. This project will yield multiple deliverables to innovate cancer survivorship care, chiefly an optimized, scalable, virtually delivered intervention that addresses chronic insomnia, one of the most deleterious concerns among the among the steadily increasing number of cancer survivors.

Eligibility Criteria:
Inclusion Criteria:

* History of nonmetastatic, localized, or regional solid or blood malignancy(ies)
* Completion of primary cancer treatment (radiation, surgery, and/or chemotherapy). Use of hormonal, maintenance, oral, and immunotherapies is permitted.
* Chronic insomnia (DSM-5 criteria)
* 18 years of age or older

Exclusion Criteria:

* Self-reported inability to speak and write in English
* Undertreated noninsomnia sleep disorder (e.g., sleep apnea)
* Undertreated epilepsy, undertreated serious mental illness, undertreated suicidality, and/or psychiatric hospitalization in the past year
* Unwilling or unable to discontinue night shift work
Piroxicam Premedication for Postendodontic Pain in Non-vital Mandibular Molars

The aim of the study is to evaluate the effect of piroxicam (20mg) compared to placebo on post-endodontic pain of single-visit endodontic treatment of non-vital mandibular molars.

* Patients will be clinically and radiographically examined and their eligibility will be assessed. Eligible patients will be treated in one visit.
* Patients will be randomly assigned to one of 2 groups: experimental group (premedication with 20 mg of piroxicam) and the control group (premedication with placebo). Each participant will receive a standard inferior alveolar nerve block injection. After endodontic treatment, patients will be given postoperative instructions and informed, in case of pain, to receive ibuprofen 200 mg as rescue medication.
* Postendodontic pain intensity and incidence at the different pain categories (No, mild, moderate, severe) will be assessed 6, 12, 24, 48, 72 hours and 7 days postoperatively using a 0-10 numerical rate scale (NRS). Analgesic intake throughout the 7 days will be recorded.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aging between 18-50 years old
2. Patients with mandibular molar with non-vital pulp.
3. Systemically- healthy patients (ASA I or II).
4. Patients who agree to attend for recall appointments and provide a written consent.

Exclusion Criteria:

1. Pregnant or lactating female patients.
2. Patients allergic to piroxicam.
3. History of peptic ulceration.
4. Periapical abscess, fistula.
5. Non-restorable teeth.
6. Moderate or severe marginal periodontitis i.e. pocket probe\>3mm.
Understanding the Role of Gender Inequality and Food Insecurity on Maternal and Child Health

To pilot test a group intervention for newly married women and their households to improve nutrition, pregnancy and delivery knowledge, and intrahousehold communication

Aim: To test the feasibility of an empowerment and food insecurity intervention for newly married women and others in their households to improve maternal and child health outcomes. The investigators will pilot an intervention consisting of groups of newly married women, their husbands and mothers-in-law. Each household will be enrolled for 4 months in weekly sessions. Topics discussed will include behavioral messaging crafted specifically for newly married households (including husbands and in-laws) to address the perceptions of different family members about food consumption, gender inequality, and the relationship between women's nutrition, food consumption, maternal health, and birth outcomes. Behavioral messaging at the household level: Based on findings from preliminary studies, key barriers to newly married women receiving needed nutrition/food and potential mechanisms to address those barriers were identified, as well as informational messages that could be used to address specific barriers. Particular attention was paid to how household dynamics and decision-making relate to gender inequality and food insecurity. Thirty randomly selected newly married households will be recruited to participate in testing the feasibility and acceptability of the intervention. Acceptability will be assessed from women, husbands, and mothers-in-law through surveys at the end of 4 months with questions on relevance to their needs, information gained, and interest in participating further. Enrollment and retention at 4 months will also be used to measure acceptability. Preliminary changes in knowledge, attitudes and behaviors will be assessed through a comparison of pre and post survey data. The investigators will also conduct semi structured interviews with 15 participants and 5 stakeholders. If necessary, the intervention will then be refined.

Eligibility Criteria:
Inclusion Criteria:

* the household has a newly married couple (married in the last 3 months)
* a living mother-in-law
* both the woman and man being over the age of 18

Exclusion Criteria:

* Under 18
* not recently married
Use of Bedside Imaging and Community Health Workers for Early Screening and Referral of Pre-symptomatic Stage B Heart Failure in the Emergency Department

The goal of this clinical trial is to learn if using point-of-care ultrasound (POCUS) can increase participant engagement and changes in behavior among adults with risk factors for pre-symptomatic heart failure presenting to the emergency department. The main questions it aims to answer are:

1. Does POCUS increase understanding of heart failure and the likelihood to improve diet, exercise, and follow up?
2. Does POCUS improve diet, exercise, follow up, and self-efficacy at three months post-intervention?

Researchers will compare an educational intervention with versus without POCUS to see if POCUS works to improve outcomes.

Participants will:

Receive either the educational intervention alone or an educational intervention plus POCUS. They will report the difference in their understanding and likelihood to improve diet, exercise, and follow up immediately post-intervention. They will also report changes in diet, exercise, follow up, and self-efficacy at three months post-intervention.


Eligibility Criteria:
Inclusion Criteria:

* Must be 45 years of age or older
* Must have high blood pressure, diabetes mellitus, or obesity (body mass index ≥30 kg/m2)

Exclusion Criteria:

* Symptoms of acute heart failure (difficulty breathing, leg swelling)
* History of heart failure
* Unable to tolerate an ultrasound examination
* No access to a phone for follow up
Family ICU Delirium Detection Study

To evaluate the validity, reliability, and acceptability of employing family-administered delirium detection tools in the critically ill. The ultimate goal of this project is to improve the care of critically ill patients by creating valid, earlier, and patient and family-centered prevention, recognition, and management of delirium.

Delirium is a major problem in critically ill patients, affecting almost half of this population. Delirium is associated with substantial persistent impaired cognition and psychiatric comorbidity, attributable mortality, and increased healthcare costs. Family members of critically ill patients are also at risk for developing adverse consequences including anxiety and depression. One strategy that may help both patients and families is to engage family members in the detection of delirium. The Facilitated Sensemaking model (of family member/patient engagement in critical care) is the theoretical framework underpinning the proposed work. Facilitated Sensemaking engages families by providing opportunities to participate in communication, decision-making, and bedside care, with the understanding that a sense of purpose derived from active participation in care can serve as a protective mechanism to reduce stress-related complications among families of critically ill patients, known as Post-Intensive Care Syndrome-Family. Family delirium detection may result in earlier and more accurate recognition of delirium and meaningful family involvement, and therein the potential for better patient and family outcomes. Family-administered tools to measure delirium exist, but they have not been explored in the intensive care unit (ICU) context; the ICU is unique in terms of the patient population served and the invasiveness of therapies employed. We propose to evaluate the validity and reliability of using family-administered tools to detect delirium in critically ill patients and to explore perceptions and experiences of family members' participation in the detection of delirium.

Aim 1: To assess the validity and reliability of the Family Confusion Assessment Method (FAM-CAM) and Sour Seven to detect delirium in critically ill patients (Phase 1).

Aim 2: To explore stakeholder (former ICU patients and family members, nurse, physician) perceptions and experiences of family-administered delirium detection in critically ill patients (Phase 2).

Eligibility Criteria:
Inclusion Criteria:

* Richmond Agitation Sedation Scale (RASS) ≥-3
* able to communicate with study team (understand English, no significant hearing impairment)
* located in ICU

Exclusion Criteria:

* Significant primary direct brain injury with a Glasgow Coma Score (GCS) of \<9
A Brief Cognitive Intervention After Intrusive Memories of Trauma With Young Refugees

This research study is designed to investigate the use of a simple cognitive task (a memory cue and 10 minute time gap, followed by playing the computer game "Tetris") for decreasing the number of intrusive memories of trauma among young refugees and asylum seekers. The design is a single case experimental AB design with or without optional replication (ABAB). Participants will aim to complete a no-intervention phase ('A': baseline phase) of one week followed by a one-week intervention phase ('B'), including a one-session intervention with a researcher comprising the simple cognitive task, followed by instructions to continue to use the technique self-guided in the subsequent week. Follow ups are conducted after each week to monitor the occurrence of intrusive memories of trauma in a pen-and-paper diary. It is predicted that participants will report fewer intrusive memories during the intervention phase than during the preceding baseline phase.


Eligibility Criteria:
Inclusion Criteria:

* Refugee or asylum seeker
* Experiencing intrusive memories of trauma
* Have access to a smartphone
* Able to speak or read the study material in Swedish, English or Arabic
* Able to attend three meetings with a researcher

Exclusion Criteria:

* Exhibit psychotic symptoms or other symptoms of severe mental illness
Study to Assess Adverse Events, Change in Disease Activity and How Oral ABBV-552 Capsules Moves Through the Body of Participants Aged 50 to 90 Years With Mild Alzheimer's Disease

Alzheimer's disease (AD) is a progressive, irreversible neurological disorder and is the most common cause of dementia in the elderly population. Clinical symptoms of the disease may begin with occasional forgetfulness such as misplacement of items, forgetting important dates or events, and may progress to noticeable memory loss, increased confusion and agitation, and eventually, loss of independence and non-responsiveness. This study will assess how safe and effective ABBV-552 is in treating symptoms of early AD. Adverse events, change in disease activity, how ABBV-552 moves through body of participants and the body response to ABBV-552 will be assessed.

ABBV-552 is an investigational drug being developed for the treatment of Alzheimer's disease (AD). Study doctors put the participants in 1 of 4 groups (3 active dose groups and a placebo group), called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to placebo. Approximately 240 participants aged 50-90 years with mild AD will be enrolled in approximately 60 sites across the world.

Participants will receive oral ABBV-552 or placebo capsules once daily for 12 weeks and followed for 30 days after the last dose of study drug.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of probable Alzheimer's disease according to the National Institute of Aging-Alzheimer's Association (NIA-AA) (2011) criteria.
* Mini-Mental State Examination (MMSE) score of 20 to 26, a Clinical Dementia Rating (CDR) global score of 0.5 or 1.0, with a CDR memory score of 0.5 or higher, and at least 1 CDR functional domain (community affairs, home and hobbies, or personal care) score of 0.5 or higher at Screening Visit 1.

Exclusion Criteria:

- Clinically significant and/or unstable medical conditions or any other reason that the investigator determines would interfere with participation in this study (e.g., unlikely to adhere to the study or procedures, keep appointments, or is planning to relocate during the study) or would make the participant an unsuitable candidate to receive ABBV-552.
The Association Between Pain Catastrophizing Scale Score and Postspinal Headache

This study is aimed to elucidate the association between Pain Catastrophizing Scale Score and Postspinal Headache in Patients Underwent Cesarean Section With Spinal Anesthesia.

This study is aimed to elucidate the association between Pain Catastrophizing Scale Score and Postspinal Headache in Patients Underwent Cesarean Section With Spinal Anesthesia. Patients were asked to fill the questionnaire booklet including Pain Catastrophizing Scale, Beck Depression Inventory and Beck Anxiety Inventory before elective cesarean section in preoperative room in operating theater. In postoperative second and fourth day, patients will call by phone and be asked to have headache or any complaints. The intensity of headache will evaluate by using visual analog scale. Age, gender, and visual analog scale scores will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists score of I, II, III
* without a history of cerebrovascular diseases
* without any presence of psychiatric diseases

Exclusion Criteria:

* severe liver, kidney and cardiovascular diseases
* peripheral arterial diseases
* a history of allergy to local anesthetics
* patients without cooperation
* not to participate in the study
* presence of neurologic or neuromuscular diseases
Qidong Hepatitis B Intervention Study

During 1983-1990 in the Jiangsu province of China, 80,000 infants were randomised by area of birth between control, standard Hepatitis B vaccination (at 0, 1 and 6 months of age) and standard vaccination plus a booster dose at about 2 to 3 years of age. The aim is to prevent establishment of chronic HBV infection in early childhood, hence to prevent the morbidity of chronic hepatitis B in young adolescents and the incidence/mortality several decades later from liver cancer and other HBV related chronic liver diseases. Long-term follow-up through central registries will determine the impact of vaccination on liver cancer incidence and mortality.


Eligibility Criteria:
Inclusion Criteria:

all infants born in Qidong between September 1983 and November 1990

Exclusion Criteria:

-
Macrolane for Enhancement of the Shape and Fullness of the Female Breast

The study evaluates treatment procedure, efficacy and safety of Macrolane for female breast enhancement.

This study evaluates the injection technique and treatment outcome by stepwise inclusion and treatment of Macrolane for female breast enhancement.

Eligibility Criteria:
Inclusion Criteria:

* Female between 25 and 50 years of age with small breasts seeking enhancement of the shape and fullness of the breast

Exclusion Criteria:

* Unreasonable expectations
* Any medical condition that may interfere with the treatment
Study of Efficacy and Safety of Seroquel (Quetiapine Fumarate) as Mono-Therapy for Acute Schizophrenic

The primary objective of the study is to evaluate the efficacy of quetiapine fumarate (Seroquel) with daily dose 600mg-750mg used as mono-therapy in the treatment of acute schizophrenic patients by evaluation of the change from baseline in PANSS total score at Day 56 using the last observation carried forward (LOCF) method.


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent for study participation before initiation of any study related procedures, signed by the patient's legal guardian
* Female and/or male, aged between 18 and 60 years (inclusive)
* Is hospitalised in a psychiatric unit with an acute episode of schizophrenia defined by CCMD-3 criteria as one of the following: \[20.1\] paranoid schizophrenia, \[20.2\] hebephrenic schizophrenia, \[20.3\] catatonic schizophrenia, \[20.5\] undifferentiated schizophrenia

Exclusion Criteria:

* CCMD-3 diagnosis of mental retardation
* Psychosis judged to be the direct physiological effect of an abused medication or substance
Reducing High School Athletes' Prescription Opioids Misuse and Diversion Through the Student Athlete Wellness Portal

The goal of this study is to prevent prescription opioid misuse among high school athletes by developing, demonstrating the feasibility, and evaluating the outcomes of an innovative digital intervention.

The goal of this proposal is to prevent prescription opioid misuse among high school athletes by developing, demonstrating the feasibility, and evaluating the outcomes of an innovative digital intervention. The new program, the Student Athlete Wellness Portal (SAWP), will be a brief, web- and smartphone-based curriculum, and will encourage resistance to cultural influences to misuse prescription opioids. This portal, which was created based on formative interviews with athletes, coaches, athletic trainers, and school administrators, will be tested in a feasibility trial. One hundred and two high school athletes completed a pretest, participated in the treatment (the SAWP) and completed posttest assess their knowledge, perceptions, and behaviors relating to opioid medication.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking male and female adolescents
* Ages 13-19
* Attending middle or high school
* Playing at last one interscholastic sport
* Parental consent

Exclusion Criteria:

* No parental consent
* outside the age range
* not participating in interscholastic sports
* not in middle or high school
* participated in the Phase I research