cyrilzakka/clinical-trials huggingface dataset:
Acupuncture for Blunt Chest Trauma

Introduction:

Chest blunt trauma accounts in up to 65% of polytrauma patients. In patients with 0-2 rib fracture, the treatment is relatively limited to oral pain killer and breathing exercise. The patients will suffer two weeks of severe pain accompanied with poor sleep and inability to preform simple daily live activities. In this double blind randomized control study, the investigators offer acupuncture as an additional treatment option.

Methods:

The study is a double blind randomized control trial. the study will include the press needle acupuncture (Acu) and placebo (Con) group. Both groups will receive one treatment, following the first visit to the clinic after chest trauma accident.

Introduction:

Chest blunt trauma accounts in up to 65% of polytrauma patients. In patients with 0-2 rib fracture, the treatment is relatively limited to oral pain killer and breathing exercise. The patients will suffer two weeks of severe pain accompanied with poor sleep and inability to preform simple daily live activities. In this double blind randomized control study, the investigators offer acupuncture as an additional treatment option.

Methods:

The study is a double blind randomized control trial. the study goal is to examine the effect of acupuncture on patients with chest trauma. the study will include totally 72 patients and divide them to two group; the press needle acupuncture (Acu) and placebo (Con) group. Both groups will receive one treatment, following the first visit to the clinic after chest trauma accident. Follow up time will be 3 months.

Expected outcome:

The results of this study can potentially provide a simple and cost effective provide analgesic solution to blunt chest trauma patients. The study design can serve as supporting evidence for future double blind studies in acupuncture.

Other information:

The study will be conducted in thoracic surgical department and acupuncture department in China medical university hospital, Taichung, Taiwan. The study is conducted on blunt chest injury patients and is anticipated to have minimum risk for adverse events. Enrollment of the patients and data collection will start after March 2020. The study expected completion time will be March 2022.

Keywords: blunt chest trauma, acupuncture, press tack needle, rib fracture

Eligibility Criteria:
Inclusion Criteria:

* Age 20-80 year-old
* Patients have chest trauma described by themselves or medical chart record within one week
* Injury Severity Score (ISS) is less than 18 points
* Body Mass Index(BMI)\<30

Exclusion Criteria:

* Sternal fracture
* Injury Severity Score (ISS) is equal or more than 18 points
* History of intercostal nerve injury
* History of cardiovascular disease
* History of chronic lung disease
* Significant lung mass or chest deformity noted in the chest plain film
Neural Mechanisms of Tactile Priming on Social Perceptions - Pilot Study

The investigators measure brain responses of healthy participants while they perform evaluation tasks inside the fMRI. For each task the participants were primed with tactile stimuli. Results should demonstrate engagement of sensorimotor brain regions after priming, hence confirming embodiment theories.

Brain responses of healthy participants were recorded with functional magnetic resonance imaging (fMRI). While being scanned participants were asked to recommend punishments similar to judges or juries for perpetrators across different scenarios. In addition, participants were primed before reading the scenario by using different materials. Based on recent theories about "embodied cognition" and extralegal factors investigators hypothesize that those primes may influence the harshness of punishments recommended by the participants. If those processes engage sensorimotor cortices, the results would strongly support theories of embodied cognition.

The results would help the investigators to understand the neural correlates of priming processes. These unconscious complex processes of perception may be important for hospital patients. Thus, beneficial haptic experiences during the hospital stay may contribute to successful recovery.

Eligibility Criteria:
Inclusion Criteria:

* male or female healthy participants
* age 18 - 40 years

Exclusion Criteria:

* cardiac pacemaker
* metallic implants
* ferromagnetic parts in / at the body
* tatoos
* vessel surgery
* tinnitus
* epilepsia
* claustrophobia
* pregnancy
Reinforcement of Placebo Response in Knee Osteoarthritis: A Randomised Trial

Saline intra-articular injections used as placebo treatments have been shown to provide pain relief in knee osteoarthritis (OA) It has further been shown that beneficial effects can be induced merely by having a conversation with a health professional.

The aim of this study is to determine whether an individual conversation based on the individual's illness perception related to knee OA affects the response to an intra-articular treatment with saline in individuals with knee OA.

Despite many years of research, there is still considerable uncertainty on what causes placebo effects and how these are mediated. Saline is a pharmacologically inert agent frequently used as placebo comparator in clinical trials of intra-articular (IA) treatments for knee osteoarthritis (OA) and patients often experience a significant pain improvement from this treatment even when it is administered as an open label placebo treatment.

It has further been shown that beneficial effects can be induced merely by having a conversation with a health professional and several studies have found the alliance between therapist and patient to have a positive effect on treatment outcome in physical rehabilitation indicating that positive attention by itself leads to beneficial treatment outcomes. Still it is unclear wether the effect of an open label placebo treatment can be influenced by a conversation and if the extent of this infleuence depends on the focus of the conversation.

The aim of this study is to determine whether a conversation about the individual's illness perception related to knee OA affects the response to a placebo treatment (saline injection) in individuals with knee OA.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥50 years
* A clinical diagnosis of tibiofemoral OA in the target knee according to the American College of Rheumatology
* Average knee pain in the last week during weight bearing activities of at least 4 on a 0 to 10 points scale (0=no pain; 10=worst possible pain).

Exclusion Criteria:

* Not able to speak or understand Danish
* Scheduled surgery during study participation
* History of target knee surgery within 12 months
* History of arthroplasty in the target knee
* Injection therapy in either knee within 3 months
* Current use of oral glucocorticoids
* Current use of synthetic or non-synthetic opioids
* Contraindications to intra-articular injections, such as wounds or skin rash over injection site.
* Planning to start or discontinue other treatment for knee OA in the study participation period
* Inflammatory arthritis, such as rheumatoid arthritis or psoriatic arthritis.
* Regional pain syndromes
* Generalised pain syndromes such as fibromyalgia
* Lumbar or cervical nerve root compression syndromes
* Any other condition or impairment that, in the opinion of the investigator, makes a potential participant unsuitable for participation or which obstruct participation, such as large knee joint effusion, uncontrolled diabetes, psychiatric and/or neurological disorders, or opiate dependency
HyperHAES Versus Placebo - Effect on Intracranial Pressure in SAH Patients

The purpose of this study is to determine whether 7.2% NaCl in 6% hydroxyethyl starch will lower intracranial pressure (ICP) in SAH-patients with normal or moderately elevated ICP in a placebo controlled study, and to describe the haemodynamic effects.

In the acute phase after a SAH, many patients need intensive care treatment to control the development of fatally increased intracranial pressure. One type of treatment used is osmotherapy. Traditionally mannitol has been the preferred drug, but the use of hypertonic saline solutions has gained more and more acceptance. The immediate effect seems to be equivalent or better than with mannitol, and there seem to be less adverse effects, such as hypovolemia, acute renal failure, hyponatremia, and rebound increase of ICP.

Most clinical studies in patients with life-threatening increase in ICP are observational, and show a predictable effect of hypertonic saline. We wanted to strengthen our own findings from such a study by applying the same study model but with a placebo control group in patients with only moderately elevated ICP.

We also wanted to document the haemodynamic effects, measuring cardiac output, intrathorasic blood volume and extravascular lung water.

Eligibility Criteria:
Inclusion criteria:

* Subarachnoid Hemorrhage, source of bleeding radiologically or surgically secured
* Age \> 18 years
* Mechanically ventilated
* Sedated
* Stable hemodynamics
* Stable intracranial pressure between 10 - 20 mmHg

Exclusion criteria:

- Serum sodium \> 160 mmol/l
Locally Applied Antibiotics for Infection Prophylaxis in Treatment of Open Fractures

The primary objective of this study is to investigate the effectiveness of local antibiotic versus placebo in the prevention of infections in open fractures. The study will assess whether local treatment of open fractures with the antibiotic tobramycin (in addition to standard systemic antibiotics) will decrease the risk and rate of infection, and rate of re-operation. This will be studied using a randomized controlled clinical trial design in adult population of age 18-70 years who present with open fractures. About 133 subjects will be recruited in this study at UVA.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18 - 70 years
* Gustilo Type I,II,IIIa open fracture (s)
* Ability to provide informed consent (or proxy consent in cases where subject is temporarily impaired when intubated and sedated)
* Subject should be able to follow up at the scheduled times following surgery
* Subjects who may have compartment syndrome, renal insufficiency, and those who are immunosuppressed regardless of antibiotic administration will also be included in the study

Exclusion Criteria:

* Closed fracture
* Severe injury requiring flap coverage or vascular reconstruction (Gustilo-Anderson Type IIIB and C respectively)
* Aminoglycoside allergy
* Presentation greater than 48 hours after injury
* Pathologic fracture
* Preexisting infection in bone with an open fracture
* Patients with multiple trauma involving liver, kidney, or brain
* Pregnancy (self-reported)
* Current status as prisoner
Healthy Living in Pregnancy

Multicenter and multidisciplinary public health project in 10 regions of Bavaria, a federal state of Germany, targeting maternal and fetal health. The objective of this trial is to evaluate the efficacy of a lifestyle intervention program focusing on diet, physical activity and weight monitoring during pregnancy. The intervention comprises 4 individual counseling sessions addressing healthy living. Primary outcome: gestational weight gain. Secondary outcomes are pregnancy and obstetric complications like gestational diabetes and rate of caesarean sections as well as offspring health.

The lifestyle intervention program is adapted to the German health care system to allow an immediate implementation after successful evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age ≤ 12th week of gestation
* Age: 18 years to 43 years
* Prepregnancy BMI ≥ 18.5 kg/m2 and ≤ 40.0 kg/m2
* Sufficient German language skills
* Written informed consent

Exclusion Criteria:

* Multiple pregnancy
* Any condition preventing physical activity such as placenta praevia, persistent bleeding, cervical incompetence
* Prepregnancy diabetes or early diagnosed gestational diabetes
* Uncontrolled chronic diseases (e.g. thyroid dysfunction)
* Psychiatric or psychosomatic diseases
* Any condition that may interfere with the study protocol
Recovery Group Pilot

The purpose of this study is to develop and evaluate a low-cost, joint consumer/counselor-led, health education and support intervention that will foster self-care and recovery among adults with serious mental illness. Results from the study will indicate how well the workbook and the overall program were received by individuals with serious mental illness, and whether participating in the program appeared to improve recovery and functioning.

Recent research suggests that many individuals with serious mental illnesses may recover from these conditions and become fully integrated into their communities. Although improved medications may be most responsible for these developments, self-help groups, social support, and empowerment have been identified as important facilitators of the recovery process. Recovery-oriented, consumer-led approaches are gaining in popularity, but few of these interventions have been evaluated scientifically.

This pilot study proposes to develop and evaluate a recovery-oriented program that centers on the use of a self-help workbook. Results from the study will indicate how well the workbook and the overall program were received by individuals with serious mental illness, and whether participating in the program appeared to improve recovery and functioning.

Objectives:

1. To develop group-facilitator materials to complement the self-help workbook.
2. To conduct a randomized trial of the intervention with kaiser Permanente Northwest (KPNW) members with bipolar disorder or schizophrenia/schizoaffective disorder, using a delayed control group design and 6- and 12-month post-intervention follow-up.
3. To assess participant attendance and satisfaction with the group sessions;
4. To assess whether participating in the group intervention was associated with improvements in short-term recovery and functioning.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of bipolar disorder or schizophrenia/schizoaffective disorder
* current membership in KPNW
* age 18 or over

Exclusion Criteria:

* having a guardian
* psychotic symptoms that interfere with group interactions
* dementia, mental retardation (other than mild) or other organic brain conditions that affect an individual's ability to participate in an interview, a group intervention, or complete questionnaires
Safety Skills Training For Parents of Preschool Children

As the leading cause of death and disability in children in America, unintentional injuries are a critical public health issue. Most injuries can be prevented by parents implementing effective child safety practices. This project produced an interactive multimedia (IMM) program delivered via Internet/Intranet that taught injury prevention skills to parents of children aged 2 through 5 years, with the ultimate goal of reducing mortality and disability from unintentional injury in this population.

This project produced a comprehensive, interactive multimedia (IMM) program called Family Safety 123 to teach childhood injury prevention skills to parents of children 2 to 5 years of age. The program contained 40 high-quality video clips, each 2 to 5 minutes in length, depicting injury prevention strategies in 13 content areas: supervision, preventing airway obstructions, poison awareness, preventing burns, preventing falls, firearm safety, motor vehicle safety, pedestrian awareness, sports, playgrounds, water safety, bike safety, and other safety concerns. Each content area contained 1 to 6 videos comprised of short video presentations, modeling vignettes demonstrating desired behaviors, supportive testimonials, and suggestions for modifications to home and recreational environments. Family Safety 123 video content is derived from The Injury Prevention Program (TIPP) sheets developed by the American Academy of Pediatrics, which recognizes injury prevention as a primary topic for parents.

Eligibility Criteria:
Inclusion Criteria:

* Parents of children aged 2-5 potentially were as young as 18 years old. Parents or legal guardians could potentially be as old as 65 or older.

Exclusion Criteria:

* Only English-speaking participants were accepted because the program was developed only for English speakers. All English-speaking parents of children aged 2-5 years old who wished to participate were included. Online Survey: parents under 18 years of age were excluded because we were unable to obtain parental consent online.
The Effects of VR Interactive Games on Balance and Quality of Life Enhancement for Elderly in the Community

The goal of this clinical trial is to learn about the effectiveness of the incorporating VR interactive games into exercise courses of the elderly in the community.The main questions It aims to answer are: can It improve their balance ability and the quality of life.

Participants will receive a Twelve-week intervention of 36 sessions using VR interactive games in their exercise prescription, While the control group will follow the original iInstructor-led exercise intervention as the course content.

Both groups will undergo three sessions per week, one hour per session, for a total of 12 weeks and 36 sessions of intervention. Before and after competing all sessions, the effectiveness of this intervention will be assessed.

Some physical assessments will be done by all participants such as 2-minute step, right chair sit and reach, left chair sit and reach to compare if any difference between two groups. and participants will do a questionaire to evaluate the psychological and environmental quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 65 or above
2. Capable of communicating in Mandarin or Taiwanese, and willing to participate in interviews or complete questionnaires
3. Free of mobility impairments

Exclusion Criteria:

1. Stroke with sequelae of mobility impairments
2. Parkinson's disease
3. Motor neurone disease
4. Severe Cardio-vascular disease
5. Degenerative joint disease with flare-ups in past three months
6. With a lower limb joint surgery in past 3 months
7. Vertigo
Effects of Morningness on Night Split Shift Performance

The goal is to investigate if the morningness-eveningness dimension mediates sleep and function on spilt night shifts (midnight-4am and 4am-8am).

Does those with high score of morningness function relatively better on the last compared to the first split shift?

Participants will:

Record their sleep from 2 days prior to 2 days following the split shift During the shifts complete questionnaires assessing mood, sleepiness and perceived performance as well as complete cognitive tests: Psychomotor vigilance test, digit symbol substitution test, working memory scanning test, reversal learning test, and visual search test

A sample of 28 students will be recruited and exposed to two conditions in a randomized, controlled, crossover study. They will be assessed with subjective (sleep diary) and objective sleep measures (sleep radar) for 2 days before the night shift, during the night shift and 2 days following the night shift. The simulated night shifts will last from midnight to 8am and will be divided into two halves (midnight-4am and 4am-8am), denoted as split-shift, and for each participant separated by at least 1 week. Based on the Horne-Östberg Morningness-Eveningness Questionnaire (median spilt) two groups are created, from which participants will be randomized to the two orders of the spilt-shift.

Each hour on each shift the participants will complete: Positive and Negative Affect Schedule (PANAS), Karolinska Sleepiness Scale, perceived performance and the following cognitive tests: Psychomotor vigilance test, Digit symbol substitution test, Working memory scanning test, Reversal learning test, and Visual search test.

Data will be analyzed with linear mixed models with three fixed factors: Group (low vs. high morningness), shift (midnight-4am vs. 4am-8am), and hour and one random factor (participant).

Eligibility Criteria:
Inclusion Criteria:

* 18-40 years old
* no incorrectable vision problems

Exclusion Criteria:

\* regular use of sleep medication
Transcriptomic Profile of Adipose Tissue Following n-3 Polyunsaturated Fatty Acid (PUFA) Supplementation

Adipose tissue is a central organ involved in mediating metabolic health, and so the investigation of treatments which improve adipose tissue function is warranted. LC n-3 polyunsaturated fatty acid (PUFA) have been shown to exert positive effects on adipose tissue gene expression in previous studies. However this has not been investigated in women with polycystic ovary syndrome (PCOS), a population shown to display a degree of adipose tissue dysfunction. The aim of this study was to determine the impact of LC n-3 PUFA supplementation on gene expression profiles of women with PCOS.


Eligibility Criteria:
Inclusion Criteria:

* Had a positive diagnosis of PCOS as defined according to the NIH criteria as chronic oligomenorrhoea (\< 9 menstrual cycles per year) and clinical and/or biochemical evidence of hyperandrogenism, in the absence of other disorders causing the same phenotype. Clinical criteria included hirsutism with a Ferriman-Galwey score greater than 9, acne or male pattern alopecia; biochemical criteria included total-testosterone, androstenedione or dehydroepiandrosterone sulphate (DHEAS) greater than the laboratory reference range.
* Were between the ages of 18 and 40

Exclusion Criteria:

* Were under 18 years or greater than 40 years old,
* Were non-Caucasian
* Were pregnant, lactating or trying to conceive
* Had a body mass index (BMI) \<18kg/m2 or \>50kg/m2
* Had a recent illness or any chronic illness likely to influence results
* Were taking any medications likely to influence the results including hormonal contraception, antihypertensives, lipid lowering medications, antiplatelet agents, anti-inflammatory agents
* Were taking nutritional supplements
* Consumed greater than 2 portions of oily fish per week
Outcome Study of Double Bare Stent for Malignant Gastric Outlet Obstruction

Self-expandable metallic stents provide effective palliation of malignant gastric outlet obstruction. However, uncovered stent are often associated with re-stenosis caused by tumor in-growth through the stent mesh. The Self-expandable metallic stents which has the design of smaller wire mesh size (double bare stent) were developed and used in Korea. This new design was developed to minimize the re-stenosis of uncovered stent, but the outcome is unknown. The end point of this study is the 8-weeks patency rate after placement of double bare as well as technical and clinical success rates.


Eligibility Criteria:
Inclusion Criteria:

* Malignant gastric outlet obstruction
* Symptoms compatible with gastric outlet obstruction
* An inoperable condition because of extent of disease or patient's conditions

Exclusion Criteria:

* History of enteral stent placement, undergone gastric surgery.
* Additional small bowel stenosis distal to gastric outlet obstruction.
* Refuse to be enrolled to study.