cyrilzakka/clinical-trials huggingface dataset:
Real-time Intervention for Suicide Risk Reduction

The aim of this study is to determine whether learning three skills for managing negative emotions and receiving reminders via smartphone to practice these skills reduces how often and how intensely one experiences emotional distress and suicidal thoughts.

The present study is a two-arm parallel design RCT to test the efficacy of using ecological momentary intervention (EMI) to deliver therapeutic content based on the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) - an evidence-based transdiagnostic cognitive behavioral therapy (CBT) that focuses on delivering adaptive skills for managing strong emotions. Participants in this study will be 50 adult psychiatric inpatients with recent suicidal thoughts or behaviors (STBs). Participants will be randomized to receive either the control condition, which consists of treatment as usual (TAU; n = 25) and 4x/daily daily ecological momentary assessment (EMA) of emotions and STBs, or the experimental condition, consisting of TAU, 4x/daily EMA, 3 brief sessions to deliver CBT skills (mindful emotion awareness, cognitive flexibility, and changing emotional behaviors, all drawn from the UP), one discretionary skills booster session, and EMI to prompt guided skills practice (n = 25).

Control participants will receive TAU and be prompted to complete 4x/day EMA of emotions and STBs for the duration of their hospital stay and the 28-day post-discharge period. Participants randomized to the experimental conditions will receive TAU plus three brief treatment sessions delivering core UP skills content (during inpatient stays) and a discretionary booster session to reinforce treatment sessions that may be offered after discharge via either phone or telehealth. Those in the experimental condition will also receive training to use the EMI (which prompts guided skills practice), followed by smartphone-based EMA/EMI for the duration of the inpatient stay and the 28-day post-discharge period.

Eligibility Criteria:
Inclusion Criteria:

* adult status (18+ years),
* a recent suicide attempt or any report of current suicidal ideation,
* the ability to speak and write English fluently,
* ownership of and consistent access to an internet-capable smartphone (e.g., an iPhone or Android phone), and
* providing at least one collateral contact in cases where we cannot reach the participant

Exclusion criteria:

- the presence of any factor that impairs an individual's ability to provide informed consent and comprehend and effectively participate in the study including: an inability to speak or write English fluently, the presence of gross cognitive impairment due to florid psychosis, intellectual disability, dementia, acute intoxication, or the presence of extremely agitated or violent behavior.
Transcranial Direct Current Stimulation Therapy for Sleepiness Related to Shift Work Disorder (tDCS-SWORD)

1. To determine the effects of tDCS on subjective measures of sleepiness in night-shift workers with shift work disorder.
2. To determine the effects of transcranial direct current stimulation (tDCS) on vigilance in night-shift workers with shift work disorder.

This is a preliminary single-arm study. The study will last up to 6 weeks including the screening period. Subjects will receive active tDCS for 30 minutes before their scheduled work hours at least 3x/week for two consecutive weeks.

Outcome measures will include: psychomotor vigilance test (PVT) and the Karolinska Sleepiness Scale (KSS)25,26 which will be obtained during the shift work.

Eligibility Criteria:
Inclusion Criteria:

* age 18-65 years
* works 5 or more night shifts per month (each shift lasting at least 10 hours, with ≥6 hours worked between 10 pm and 8 am) with plans to maintain this schedule for the duration of the 3-week trial
* meets the criteria for Shift Work Disorder according to the International Classification of Sleep Disorders24 and evaluation of a sleep medicine provider (physician or nurse practitioner) during a screening evaluation:

  1. affirmative answers to Do you experience excessive sleepiness? (yes/no); "Do you experience difficulties with falling asleep during opportunities for sleep? (yes/no); "Is the sleep or sleepiness problem related to a work schedule where you have to work when you would normally sleep? (yes/no)"; and "Has this sleep or sleepiness problem related to your work schedule persisted for at least three months? (yes/no)
  2. based on the evaluation of the sleep medicine provider, the sleep and/or wake disturbance are not better explained by another current sleep disorder, medical or neurologic disorder, mental disorder, medication use, poor sleep hygiene, or substance abuse disorder.
* Stable medication dosage over previous 4 weeks.
* Able to understand English and give a written informed consent document.

Exclusion Criteria:

* Currently taking stimulant medications such as Modafinil, Armodafinil, Methylphenidate, or Dextroamphetamine.
* History of automobile accident due to falling asleep while driving
* Inability to understand or read English
* Self-reported Substance abuse (current)
* Excessive alcohol consumption defined as:
* More than 3 glasses of wine a day
* More than 3 beers a day
* More than 60 mL of hard liquor a day
* Presence of cardiac pacemaker or automatic implantable cardioverter-defibrillator (AICD).
* Pregnancy, lactation (will be screened with urine pregnancy test)
* Non-removable metal or tattoos around head
* Use of implantable birth control device such as Implanon
* History of frequent severe headaches
* Unstable coronary artery disease
* Uncontrolled Seizure disorder
* Uncontrolled hypertension
* Any other clinically significant condition that, in the opinion of the Investigator, might put the subject at risk of harm during the study or might adversely affect the interpretation of the study data.
Minimal Invasive Surgery in Total Hip Arthroplasty Patients; Short- and Long Term Results

The aim of the present study is to explore the most efficient surgical approach in total hip replacement in short and long term when concerning strength, functionality and postoperative complications.

The objective is to register muscular strength, hip joint functionality/mobilisation and complications after total hip arthroplasty (THA) performed by the direct lateral approach (DLA), the posterior approach (PA) and the anterior approach (AA). The latter is a modified Smith-Petersen approach which follows the principles of minimally invasive surgery (MIS).

The primary working hypothesis is that due to a minimal dissection and reduced trauma in the muscles, patients will tolerate early hospital discharge better after the AA than the PA and the DLA. Patients in the AA group are also thought to be more active and maintain muscular strength and hip joint functionality/mobilisation better than patients in the lateral group.

With total hip replacement surgery, the orthopaedic surgeon's aim is not only pain relief for the patient, but also restoration of hip joint biomechanics resulting in a minimal functional deficit and maximal longevity of the implant. It is not exceptional that these patients still experience mild to moderate long-term impairments postoperatively. These impairments include pain, muscle weakness of the hip abductors, contracture of the hip, gait disorders, as well as weakness of hip extensors and flexors. These problems may in turn lead to complications such as joint instability and loosening of the implant.

MIS is defined as a surgical approach performed through a short skin and muscle incision to avoid injury to muscles and tendons. Following minimally invasive approach reduced muscle trauma has been found. Moreover clinical outcome improved, as the gluteus medius muscle can be spared more successfully. However, it is debated whether or not the overall results of MIS are superior, or even as good as the traditional hip replacement surgery in terms of component placing and time to revision of the prosthesis.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for THA
* Diagnosis of primary osteoarthritis as the main cause for elective THA
* American Society of Anesthesiologists (ASA) score I, II, and stable III

Exclusion Criteria:

* Musculoskeletal diseases
* Current heart/pulmonary- or malignant diseases likely to influence the physical testing performance.
Glycemic Variability: Prognostic Impact on Acute Ischemic Stroke

This is a multicenter observational clinical study in patients with acute ischemic stroke. The main objective is to evaluate the impact of glycemic variability (GV) on stroke outcome (mortality, functional recovery) of patients with acute ischemic stroke. Glycemic variability will be assessed using a subcutaneous device for continuous glycaemia motorization during 96 hours; also capillar glycaemia will be measured every 6 hours.

10 different hospitals in Spain will participate in this study, recruiting a total of 340 patients. Once the informed consent form is signed, the subcutaneous device for continuous glycaemia motorization will be implanted and demographic, comorbidities and treatments of every patient will be registered. During the first 96 hours, capillar glycaemia, NIHSS scale, HbA1C levels, cerebral recanalization treatment and glycaemia correcting treatments will also be reported. In the following days (7, 30 and 90 days after stroke) modified Rankin Scale, NIHSS scale and stroke secondary prevention treatments will be evaluated. At day 90, a new measure of HbA1C will be done.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old
* Inclusion less than 24 hours from ischemic stroke
* Functional independence prior to stroke
* Signed informed consent

Exclusion Criteria:

* Transient cerebral ischemia
* Prevision of need to perform a magnetic resonance within the first 96 hours from inclusion
* Concomitant severe or deadly disease that may interfere with study follow-up during 3 months from stroke
* Current drug or alcohol abuse that may interfere with study follow-up
* Participation in a clinical trial
TDF Long Term Study

This study will assess the safety and efficacy of generic TDF from Governmental Pharmaceutical Organization (GPO) in HIV-infected children

TDF is a nucleotide reverse transcriptase inhibitor (NRTI) which can be taken only once per day and continues to have good efficacy even in patients who have resistance to other NNRTI in the absence of K65R mutation. TDF is a choice for patients with NRTI resistance, or those that require once-daily regimen to improve adherence. Currently, TDF has not been approved by the US FDA for children less than 18 years, but pediatricians has been using TDF in children who have treatment failure because of limitation of a more appropriate pediatric ARV. The Thai national guideline for pediatric 2009 recommend the use of TDF in children who have failed the first line therapy with multi-NRTI mutation and are more than 30 kilograms or have tanner stage 4 or more. However, the problem is that there is no pediatric TDF formulation. The available preparation of 300 mg tear drop tablet, if cut in half, may increase dosing errors, more or less by 18-37%. This will affect the blood level and/or toxicities. Therefore, the Thai Governmental Pharmaceutical Organization (GPO) has produced a generic TDF formulation that can be used in HIV-infected children. This study will assess the safety and efficacy information in children using this generic pediatric TDF formulation.

Eligibility Criteria:
Inclusion Criteria:

* children who are changing to TDF due to adherence problem or treatment failure
* children who are already on TDF due to their clinical indication

Exclusion Criteria:

* child/caretaker refuse to participate in this study
* cannot adhere to the study schedule
The Effect of Music in Alzheimer's Patients

This study was randomized controlled study conducted to determine the effect of Nihavent theme on reducing adjustment difficulties in Alzheimer's patients.

The study was carried out with 30 patients.15 patients constituted the experimental group and 15 patients formed the control group. Before the application, the scale was administered to both groups through face-to-face interviews. The patients in the experimental group were informed about the music session in advance.Instrumental songs in nihavent theme were played with the sound system to the experimental group. The sessions were lasted 12 weeks in total and there were two sessions per week, and each session took approximately 50 minutes to complete. While no intervention was performed for the patients in the control group. One week after the last music session, the the scale was re-administered to both groups.

Adaptation levels of Alzheimer's patients should be determined before planning nursing interventions. Institutions should support healthcare personnel in organizing music sessions for patients. It is believed that further studies examining the effect of the Nihavent theme in decreasing adaptation difficulty in Alzheimer's patients should be conducted with larger sample groups. The effects of verbal and non-verbal music on Alzheimer's patients should also be evaluated and compared to gain further insight on this important matter.

Eligibility Criteria:
Inclusion Criteria:

* 18-90 age range
* Were conscious able to communicate and active

Exclusion Criteria:

* Change in their diagnosis, medications, consciousness, and/or drug dose
* During the study period they a regression in emotional state (crying, sadness)
* Those with complex diseases such as cancer
Veritas Laparoscopic Paraesophageal Hiatal Hernia (PEH) Repair Pilot Trial

This is an investigator initiated pilot study to observe the short-term outcomes (a follow-up period of up to six months) of patients who undergo a laparoscopic paraesophageal Hiatal hernia (PEH) repair using the Veritas® Collagen Matrix brand biological mesh. This is a preliminary study at the University of Washington.

A PEH occurs when the stomach protrudes through the diaphragm next to the esophagus. The chance of recurrence of a Hiatal hernia after laparoscopic PEH repair is between 20-40% within 6 months.During laparoscopic PEH repair, a mesh-type product is used as a scaffold. The mesh serves as a reinforcing material during the surgical repair. It is cut to the appropriate size needed for the hernia and sutured to the surrounding diaphragmatic tissue. There are many different types of meshes available on the market, and vary in the degree of manageability, strength, and adherence.

Although surgical meshes work on the same principal, the variance between materials may affect patient outcomes. There is evidence that a biologic mesh, specifically one derived from Small Intestinal Submucosa (SIS), decreases the short-term (6-month) recurrence rates compared to a synthetic mesh or another type of biologic mesh. A biologic mesh, serving as a scaffold, will be replaced by the patient's own tissue after about 6 months. Theoretically, this would prevent the possible complications associated with synthetic mesh including mesh erosion into the esophagus or stricture of the esophagus.

There are some case series showing similar short-term results between the different biologic meshes, but there is no direct comparative data.


Eligibility Criteria:
Inclusion Criteria:

A. Subjects must have a documented symptomatic paraesophageal hernia that:

* 1. Is greater than 5 cm hiatal hernia on Upper Gastrointestinal (UGI) series
* 2. Has evidence that the stomach or other viscera is present in the hernia and does not spontaneously reduce from the mediastinum
* 3. Has significant symptoms or signs of a paraesophageal hernia: heartburn, dysphagia, chest pain, shortness of breath, post-prandial abdominal pain, early satiety, odynophagia or chronic anemia

B. Consenting adult ≥18 years \~ documentation of informed consent will be recorded in the research records

C. Must be able to participate in follow-up evaluations (subjects must be fully cognitive)

D. Has a telephone

E. Free of cognitive or speech impairment

Exclusion Criteria:

A. Previous operation of the esophagus or stomach

B. Associated gastrointestinal diseases that require extensive medical or surgical intervention that might interfere with quality of life assessment (e.g. Crohn's disease)

C. Emergent operation for acute volvulus (twisting/rotation of the bowel leading to obstruction)
Tele-Harm Reduction

The purpose of this study is to test 2 different methods for offering medications that treat HIV, cure Hepatitis C Virus (HCV) (if applicable) and treat substance use disorder (if desired) to people who inject drugs.


Eligibility Criteria:
Inclusion Criteria:

* age 18 or older
* able to speak English
* enrolled in IDEA Miami or IDEA Tampa SSPs
* injection drug use in past 12 months by self-report
* willing and able to sign informed consent, provide locator information and medical records release
* testing reactive for HIV by rapid test
* HIV RNA\>200 copies/ml as determined by on-site labs or abstracted medical records (result within 3 months of randomization date)

Exclusion Criteria:

* testing HIV negative via rapid test
* receipt of THR intervention in the past 6 months
* inability to provide informed consent
* planning to leave the area within 12 months
* Principal or site investigator discretion
* currently in prison or jail
* Enrollment in Clinical Trials Network 121
Evaluation of Comfort in a Spinal Collar

This is an observational study which aims to assess the comfort of a spinal collar in patients who have them fitted as part of their clinical care due to neck injury.

The study follows the patient journey including long term follow up (up to 120 days following admission). The information gathered will be from the standard clinical care delivered and include demographics, baseline function, the injuries sustained following trauma and prescribed analgesia with records of the most recent time and dose administered. Any scans done of the neck for clinical purposes will be anonymised and analysed for measurements of angulation. In addition to this there will be a survey on the comfort of the collar and of their functional ability at the current time at various points during their inpatient admission.

Eligibility Criteria:
Inclusion Criteria:

1. All patients aged 18yrs and over with a C-spine injury immobilised in a spinal collar
2. Patients must be nursed on Major Trauma Ward
3. Ability to give informed consent to participate in the study.

Exclusion Criteria:

1. Patients under 18yrs age
2. Patients who lack capacity to consent for entry into the study
3. Patients who are receiving level 2( High dependency unit) or level 3 (Intensive care unit) clinical care
4. Patients who are unable to complete the visual analogue score or questionnaire due to having co-existent severe hearing and visual impairment. Severe hearing impairment will be defined as unable to hear the researcher with hearing aids if required. Severe visual impairment will be defined as being unable to read the patient information sheet even with visual aids.
5. Patients unable to understand the patient leaflet in English.
Improving Memory in Patients With Multiple Sclerosis

People with multiple sclerosis (MS) suffer from cognitive and other brain problems. This study will examine the effectiveness of the drug donepezil and of sugar water for enhancing memory in individuals with MS. Donepezil (also known as Aricept) has been FDA approved for improving memory and learning in individuals with Alzheimer's disease.

Cognitive dysfunction is one of the leading causes of disability in people with MS. Memory involving specific words (verbal memory) is particularly affected in individuals with MS. Attempts to rehabilitate cognitive dysfunction in MS have had only limited success.

This study will determine the efficacy of donepezil therapy and glucose administration for enhancing verbal memory functioning in individuals with MS. The study will also measure secondary outcomes assessing other areas of cognitive dysfunction (i.e., nonverbal memory, conceptual thinking, processing speed) which may improve with intervention.

Forty participants with MS will be randomly assigned to receive either donepezil or placebo for 24 weeks. Participants will complete memory and cognitive tests at the beginning and end of the 24 week period.

Twenty participants with MS will be randomly assigned to drink a beverage sweetened with either glucose or saccharin (placebo). Participants will then complete memory and other cognitive tests. Two weeks later, participants will drink a beverage sweetened with the alternative sweetener and again complete the memory and cognitive tests.

Eligibility Criteria:
Inclusion Criteria

* MS as defined by the Poser criteria
* Expanded Disability Status Scale (EDSS) score of 0 to 6.5
* Stable neurologic function for at least 30 days prior to study entry
* Agree to continue all current medications for study duration
* Rey Auditory Verbal Learning Test score in low normal range or below
* Mini-mental status exam score of 26 or higher
* Montgomery-Asberg Depression Scale scaled score of 14 or lower
* Fluent in English

Exclusion Criteria

* Use of anticholinergic or benzodiazepine medication
* Change in dosage of medications judged to have the potential to impact cognitive function (e.g., antispasticity medications) within 2 weeks of study entry
* Current alcohol or substance abuse
* History of neurological or major medical problem that has a known effect on cognitive functioning
* History of noncompliance
* Visual or upper extremity impairment which precludes ability to participate in cognitive assessment