cyrilzakka/clinical-trials huggingface dataset:
Military to Civilian: Trial of an Intervention to Promote Postdeployment Reintegration

Veterans returning from combat deployments face the interrelated challenges of processing their combat experiences and transitioning back to civilian life. Unfortunately, many veterans wait years or decades before seeking help for post-deployment problems, if they seek it at all. This study seeks to determine whether Internet-Based Expressive Writing (IB-EW), a brief, low-cost, easily disseminated, and resource-efficient intervention, can reduce psychological symptoms and improve functioning among Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF) veterans as they navigate this transition, while also attempting to reduce barriers to help-seeking. Expressive Writing, a highly private, readily accessible, and non-stigmatizing intervention, has a strong evidence-base in civilian populations, but its efficacy in combat veterans has not been tested. This study therefore seeks to test the efficacy of Expressive Writing in a veteran population while further enhancing its accessibility by delivering it over the internet (Internet-Based Expressive Writing; IB-EW). This study will comprise a randomized controlled trial with three conditions: (a) Internet-Based Expressive Writing, (b) Internet-Based Control Writing, and (c) No Writing/Treatment As Usual, with a total of 1152 OIF/OEF veterans randomized across these groups. Expressive Writing participants will write with feeling about their transition from being a soldier to being a civilian; Control Writing participants will write factually about the information needs of new veterans; and Treatment as Usual participants will complete the assessments but not engage in any writing assignments. Participants will complete standardized self-report measures of psychological symptoms, psychosocial functioning, and life satisfaction at baseline (Session 1) and at three months (Session 6) and six months (Session 7) post-intervention. Participants in writing conditions will write for 20 minutes on four consecutive days (Sessions 2-5) following completion of baseline measures (participants in the TAU condition will not complete Sessions 2-5). The study will also attempt to identify individual difference characteristics related to the efficacy of the treatment, to see who may be most likely to benefit from the treatment. Analyses will primarily entail multivariate analyses of variance. Power is adequate to detect even a small effect.


Eligibility Criteria:
Inclusion Criteria:

* Veteran from current wars in Iraq and Afghanistan
* At least a little difficulty transitioning from soldier to civilian
* Access to computer with internet
* Provide valid contact information
* Available to participate for up to 40 minutes per session
* Interested in participation
* Understand procedures and consent
* Note: participants are recruited by random selection from the target population

Exclusion Criteria:

* Severe depression
Restoration of Physical Function in Patients Following Total Knee Replacement: Comparison Between Resistive Strength Training Exercises & Ankle Weights

Techniques used to restore the physical functions in TKR patients

to restore the physical functions in TKR patients by the use of ankle weights and resistance exercises. Total 40 patients were included in this study and two groups had been formulated one as experimental and other as control. 2 sessions were given to each group for 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age of patients above 40 years with total knee arthroplasty
* 4-6 weeks following TKR

Exclusion Criteria:

* Age less than 40 patients
* Concurrent medical disease that could affect the progress (e.g., uncontrolled hypertension, advanced malignancy, decompensated cardiovascular disease.
* Pain score more than 6/10
Multicenter Study of Chloroprocaine Versus Ropivacaine for Epidural Labor Analgesia

Women requiring epidural labor analgesia were randomized into two groups, one with the local anesthetic chloroprocaine and the other with ropivacaine. The primary outcome was to observe the analgesic scores of the two groups of drugs as well as adverse reactions.

Mothers who met the study criteria vertebrae were included and then divided into two groups. Labor analgesia was provided by epidural anesthesia with a low concentration of local anesthetic (chloroprocaine or ropivacaine) combined with sufentanil. Data related to labor analgesia such as pain scores, motor tissue scores, and body temperature were collected and statistically analyzed to compare the efficacy and adverse effects of the two local anesthetics and to draw conclusions.

Eligibility Criteria:
Inclusion Criteria:

* Primigravid women with full-term pregnancies scheduled for labor analgesia
* Determination of labor onset to cervical dilatation ≤ 5cm;
* Visual analogue scale (VAS) pain score during contractions \>50 mm (0 mm = no pain at all, 100 mm = most intense pain);
* Age ≥20 years;
* American Society of Anesthesiologists (ASA) classification II
* Body mass index (BMI) between 18.5 and 30 kg/m2
* Height \>155 cm
* Signed informed consent.

Exclusion Criteria:

* Twin or multiple pregnancies
* Hypertension
* Severe cardiopulmonary and hepatic or renal disease
* Severe pregnancy comorbidities such as preeclampsia, eclampsia, HELLP syndrome, placenta praevia, placental abruption, etc.
* Cephalopelvic disproportion
* History of allergy to local anesthesia
* Spinal deformity
* Contraindications to intrathecal anesthesia
* Refusal to participate in the stud
Long-term Effect of θ Burst Magnetic Stimulation on Clinical Symptoms of Alzheimer Disease

This was a randomized, single-blind, parallel, placebo-controlled clinical trial assessing the efficacy of neuronavigational TBS among patients with AD. Fourty late-onset AD were included in the study, all the patients were divided into TBS groups and drug treatment group. Drug intervention group AD patients with drug regimen (donepezil 5mg / d) and primary care guidance, once every three months follow-up. TBS group is treated with TBS (a course of treatment every 3 months); after completing 4 treatments/follow-ups a year, evaluate the changes in MoCA, other clinical symptoms and multi-domain cognition tests, and brain Changes in structure and function.


Eligibility Criteria:
Inclusion Criteria:

* Subject diagnosed with early Alzheimer's disease or related diseases according to NINCDS-ACDRADA criteria.
* Subjects must have a MMSE score between 10 and 27,indicating mild cognitive impairment or dementia
* CDR score ≤ 2
* Subject under treatment by IAChE for at least 3 Weeks.
* psychotropic treatments are tolerated if they were administered and unchanged for at least 3 months

Exclusion Criteria:

* CDR \> 2
* Any history or clinical signs of other severe psychiatric illnesses (like major depression,psychosis or obsessive compulsive disorder).

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* History of head injury,stroke,or other neurologic disease.
* Organic brain defects on T1 or T2 images.
* History of seizures or unexplained loss of consciousness.
* Implanted pacemaker,medication pump,vagal stimulator,deep brain stimulator.
* Family history of medication refractory epilepsy.
* History of substance abuse within the last 6 months.
Constraint-induced Movement Therapy (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegic Cerebral Palsy

A randomized control trial of bimanual training. The protocols have been developed at Columbia University to be child friendly and draws upon our experience since 1997 with constraint-induced movement therapy in children with cerebral palsy.

A new treatment involving bimanual (Hand-Arm Bimanual Intensive Therapy (HABIT). The protocols have been developed at Columbia University to be child friendly and draws upon our experience since 1998 with constraint-induced movement therapy in children with cerebral palsy. The interventions are performed in a 15 day day-camp setting with several children and at least one therapist per child. We have conducted 24 day camps to date since 2002, and are now collaborating with clinicians worldwide to expand our treatment availability. The aim is to promote the use of and improve the coordination of movement of both hands together. PARTICIPATION IS FREE. Please check out our website for more information: http://www.tc.edu/centers/cit/.

Eligibility Criteria:
Inclusion Criteria:

willingness to agree to intervention and testing procedures and travel to the University for participation and testing.

Exclusion Criteria:

* health problems not associated with CP
* uncontrollable seizures
* visual problems that would interfere with carrying out the intervention or testing
* botulinum toxin therapy in the upper extremity musculature during the last six months or who wish to receive it within the period of study
Effect of Rollator on Walking Distance in Elderly Patients

To evaluate the effect of a rollator on 6 Minute Walking Test (6MWT) in elderly people.


Eligibility Criteria:
Inclusion Criteria:

* elderly people (older than 60 years)

Exclusion Criteria:

* respiratory diseases
Manual-based Art Therapy for Adolescents With Depression

There is a need to evaluate different interventions in order to meet young people's needs of treatment. The study's goal is to find out if manual-based art therapy is a useful method for young people with depression and thus increase the availability of methods of treatment for adolescents with depression in Child and youth psychiatry in Sweden.

The aim is to investigate whether manual-based art therapy is useful as treatment for adolescents with depression by examining feasibility, acceptability and compliant to treatment. Secondary, preliminary study of adolescent depressive symptoms, quality of life and functional level is affected by the treatment.

Method: Data from youths aged 13-17 years old and their parents will be collected with questionnaires and structured interviews. Measurements are taken before and after treatment. Acceptability and feasibility will be examined by participants' presence, drop out and cancellations and also by checking the art therapists' compliance to the manual and investigate their reasons to diverge from the manual


Eligibility Criteria:
Inclusion Criteria:

* Age 13-17 year
* Depression as main diagnosis

Exclusion Criteria:

* high suicide risk
* ongoing psychosis
* eating disorder
* Untreated PTSD
* Patients are excluded if there is suspicion of violence, abuse, abuse in the home or other vulnerability which requires other interventions to ensure the safety.
A Study to Assess the Pharmacokinetics and Pharmacodynamics of Canagliflozin (JNJ-28431754) in Healthy Indian Volunteers

The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how the drug affects the body) of 2 different doses of canagliflozin (JNJ-28431754) in healthy Indian volunteers.

This study will be an open-label (all volunteers and study staff know the identity of the assigned treatment), randomized (the treatment is assigned by chance), single center, single dose, 2-way cross-over study (all volunteers switch from one treatment to another) to assess the pharmacokinetics and pharmacodynamics of canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus) in healthy Indian volunteers. The study will consist of 3 phases: a single screening phase, a baseline phase of 2 days per period, and an open-label treatment phase that includes 2 treatment periods (Periods 1 and 2). During Period 1, volunteers will be randomly assigned to receive a single dose of either 200 mg (Treatment A) or 300 mg (Treatment B) of canagliflozin on Day 1. During Period 2, volunteers will receive the dose of canagliflozin (Treatment A or B) that they did not receive during Period 1. The duration of each treatment period will be 4 days and each treatment period will be separated by a 14 day washout period (when no medication is given). Each volunteer will participate in the study for approximately 45 days.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers must have a body mass index (BMI = weight in kg/height in m2) between 18 and 35 kg/m2 (inclusive) and body weight not less than 50 kg
* Volunteer must have a glomerular filtration rate (the volume of fluid filtered by the kidney) more than or equal to 90 mL/min/1.73 m2 using the Modification of Diet in Renal Disease calculation
* Fasting blood glucose at screening must be less than 100 mg/dL and the 2 hour plasma glucose following the oral glucose tolerance test (conducted at screening) must be less than 140 mg/dL

Exclusion Criteria:

* History of or currently active illness considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results
* Female volunteer is breast-feeding
* Volunteer has a history of smoking or use of nicotine-containing substances within the previous 2 months
Effect of Raspberry on Gut Microbiota and Metabolic Syndrome

There is growing evidence that nutritional intervention with dietary polyphenols can positively modulate the gut microbiota to improve cardiometabolic health. Whether the beneficial effects of raspberry on obesity and the metabolic syndrome can be linked to their potential impact on the gut microbiota and intestinal integrity remains speculative at this time. Moreover, the mechanisms of action underlying health benefits associated to raspberry consumption are still unknown. The investigators are thus proposing to combine the study of metagenomics, transcriptomics and metabolomics to test whether a prebiotic activity of raspberry can play a role in the prevention of obesity-linked metabolic syndrome in a clinical setting.


Eligibility Criteria:
Inclusion Criteria:

* Men and premenopause women in good health
* Caucasians
* At least one of the following : BMI between 25 and 40 kg/m2 or Waist circumference ≥ 80 cm for women and ≥ 94 cm for men
* At least one of the following : TG ≥ 1.35 mmol/L or fasting insulinemia ≥ 42 pmol/L

Exclusion Criteria:

* Metabolic disorders (hypertension, diabetes, hypercholesterolemia)
* Regular use of medication affecting study parameters
* Use of natural health product in the last 3 months
* Use of antibiotics in the last 3 months
* Nicotine users
* Allergy or intolerance for raspberries
* Raspberry taste aversion
* More than 2 alcohol drinks par day
* Particular dietary habits (vegetarism, gluten-free diet, cetogenic diet...)
* Weight change of more than 5% in the last 3 months
* Surgery in the last 3 months or planed during the study
Chlorhexidine Antiseptic Irrigation of the Bowel Segment During Radical Cystectomy and Urinary Diversion

This is a single arm, interventional pilot study of using chlorhexidine irrigation intra-operatively and post-operatively among patients undergoing radical cystectomy with urinary diversion. The intervention comprises of using irrigation of ileal conduit or ileal neobladder intra-operatively and then for irrigation of either post-surgery with Irrisept ®. The sterilization of urine will be assessed at 10 days after cystectomy. Incidence of symptomatic urinary tract infections within the 30-day post-operative period will be estimated.

Th research team proposes to increase the rate of sterilization of urine from patients with urinary diversion and reduce the incidence of UTI up to 30 ± 7 days post radical cystectomy and urinary diversion using 50 ± 25ml of Irrisept ® irrigation solution lavage of the bowel segment during surgery for a contact time of 2 minutes. For patients who obtain an ileal conduits irrigation using 50 ± 25ml of Irrisept ® will be performed daily for 10 days +/- 3 days and for those patients obtaining ileal neobladders irrigation using 50 ± 25ml of Irrisept ® will continue for 21 days +/- 7 days. The irrigation will continue for the given time described above as this is usually when stents and catheters are removed.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form.
* Stated availability for the duration of the study, and willingness to comply with all study procedures, including willingness to adhere to twice daily irrigation of neobladder or ileal conduit.
* Male or female, ≥ 18 years of age
* Confirmed diagnosis of bladder cancer
* Candidate for radical cystectomy with urinary diversion
* ECOG performance status of 0-2
* Serum creatinine ≤ 1.5 mg/dL

Exclusion Criteria:

* Has undergone or planned to undergo urinary diversion other than ileal conduit or neobladder.
* Pregnancy or lactation.
* Known allergic reactions to components of the Irrisept irrigating system, chlorhexidine.
* Patient must not have any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
Follow-up Gun Study: Can Safety Videos Mitigate Interest in Guns in Children?

The investigators' previous research has shown that children exposed to media characters with guns in movies and video games are more likely to use real guns themselves (e.g., touch them, hold them, pull the trigger). This research tests whether exposure to a gun safety video a week before the study can help counteract dangerous behavior around guns.

Guns are prominent in movies that target children. An analysis of top selling films found that the depiction of guns in violent scenes in PG-13 films that target youth has increased from the level of G and PG files in 1985 when the rating was introduced, to the level of R films by 2005, to exceed the level of R films since 2012, a trend that has continued.

Research in the investigator's lab has shown that children are more likely to use guns (e.g., handle them, pull the trigger) after exposure to movie characters who use guns. The investigators replicated this study using video games, and also found that children who had taken a gun safety course were less likely to engage in dangerous behavior around firearms. However, it is difficult to draw causal inferences about the gun safety course because children were not randomly assigned to take or not take a gun safety course.

The present research will aim to reduce dangerous behavior around firearms by first exposing participants to a gun safety video recorded by The Ohio State University Chief of Police. The control video is about car safety. Children will see the videos about a week before they come into the lab.

In the lab, children will be tested in pairs. They will first watch a film clip from one of two different PG rated films, either in its original form (with guns) or with the guns edited out. After exposure to the film, participants will be placed in a room with toys, including two real unloaded guns that have been modified for safety and include a trigger pull counter.

The study uses 2 (gun safety video vs. car safety video) X 2 (movie with guns vs. movie without guns) between-subjects factorial design.

The investigators predict that children will be less likely to engage in dangerous behavior around real firearms after viewing the gun safety video than those who viewed the car safety video, even if they see a movie with guns in the lab.

Eligibility Criteria:
Inclusion Criteria:

* Age 8-12 yrs
* No prior participation in the study
* Able to schedule participation with a known peer (8-12yo).

Exclusion Criteria:

* Younger than 8 yrs old
* Older than 12 yrs old
* Prior study participation
* Could not schedule participation with a known peer (8-12yo)
Study to Evaluate the Real-World Effectiveness, Safety and Tolerability of Treatment With Apremilast in Psoriatic Arthritis Patients Followed in Canadian Routine Care (APPRAISE)

This will be a Canadian observational study utilizing a prospective cohort design. Patients with active psoriatic arthritis (PsA) for whom the treating physician has decided, prior to and independently of enrollment in the study, to initiate treatment with Otezla® will be considered for participation in the study.

Patients will be enrolled from the practices of predominantly community rheumatologists and will be followed for 12 months from the time of initiation of treatment with Otezla® In line with the observational nature of the study, there will be no protocol imposed tests or assessments. However, recommended follow up visits will be at 4, 8 and 12 months. In addition, patients may be asked to voluntarily complete self-administered questionnaires.

The 24-month assessment will be aimed to determine whether or not treatment with Otezla® has been maintained, and if not, to ascertain the reason for discontinuation and what new treatment was initiated following discontinuation of Otezla®


Eligibility Criteria:
Inclusion Criteria:

* Active psoriatic arthritis (PsA) as per the Classification criteria for Psoriatic Arthritis (CASPAR) criteria, based on the investigator's clinical judgement.
* Adult patients (≥18 years of age) with PsA
* Prescribing physician has decided to initiate treatment with Otezla®, and this decision was prior to and independent of patient enrollment in the study.
* Access to commercially available Otezla®

Exclusion Criteria:

* Patients who are pregnant, breastfeeding, or who are planning on becoming pregnant during the course of the study
* Participation in Investigational Clinical Trial within the last 60 days.
Physical Activity and Chronic Acquired Brain Injury

Most individuals who have survived an acquired brain injury (ABI) present consequences affecting the sensorimotor, cognitive, affective or behavioural components. The conditions can vary from mild to extreme. The consequences of an ABI may have a considerable impact on their functioning, and secondary conditions like depression or sedentary behaviours, so they suffer changes in their Health-Related Quality of Life (HRQoL).

The purpose of this project is to determine the effect of a physical activity group program on HRQoL. As well as to identify factors that facilitate or act as a barrier to practice physical activity.

This study is a quasi experimental pre-post test with nonequivalent group design. There were two groups: 30 subjects with chronic ABI took part in a physical activity group program designed by a Sport Club in Madrid, Spain; and 30 subjects with chronic ABI which did not practice physical activity.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with mild to moderate chronic acquired brain injury from any cause.
* Being over 18 years of age.
* Being practice two or more sessions per week.
* Ability to understand and complete questionnaires in Spanish.
* Voluntary participation in the study.
* Signed informed consent by the patient and/or their primary caregiver.

Exclusion Criteria:

* Return to work
* Aphasia