cyrilzakka/clinical-trials huggingface dataset:
Exercise: A Novel Treatment for Combat Post Traumatic Stress Disorder

The primary objective of this pilot intervention study is to examine the efficacy of exercise for reducing the symptoms of posttraumatic stress disorder (PTSD) and other psychiatric and somatic symptoms. The sample will be composed of veterans aged 18-65 with combat-related PTSD (N = 40). Participants will be randomly assigned to one of two groups. Participants in the exercise training group (n = 20) will receive three 60-75 minute sessions per week of combination aerobic and resistance training for eight weeks. In the control stretching group, participants (n = 20) will receive training in whole-body flexibility three times per week for eight weeks. Secondary objectives include 1) determining feasibility of the intervention (as measured by the percentage of prescribed days of exercise completed by each participant, and percentage of time exercising completed at the prescribed intensity and duration); 2) determining the influence of exercise training on aerobic fitness and strength in the sample; and 3) determining whether psychiatric/somatic symptom improvements are associated with improvements in fitness and strength. Finally, exploratory objectives will include examining whether exercise training can improve early signs of heart disease, and whether certain biomarkers (using MRI and fMRI data and inflammatory markers) are associated with treatment response.


Eligibility Criteria:
Inclusion Criteria:

1. Ages 18-65yr
2. Diagnosis of PTSD
3. CAPS \>30
4. Reported combat exposure per the Deployment Risk and Resilience Inventory (DRRI)
5. Sedentary lifestyle (planned activity for purpose of health \< 2 days/wk)
6. Capability of giving informed consent

Exclusion Criteria:

1. Abuse of alcohol or drugs
2. Homelessness
3. Significant cognitive impairment (e.g., MMSE score of ≤ 26) that would hinder ability to understand the protocol
4. Signs or symptoms of cardiovascular, metabolic or pulmonary disease that would preclude participating in the exercise, including uncontrolled hypertension (\> 159/99 mm Hg)
5. Usage of beta blockers, which could influence the heart rate response to exercise
6. Any physical or mental health condition that would contraindicate participation in the study (e.g., musculoskeletal, orthopedic, and/or neuromuscular disorders)
7. High suicidality
8. Below cutoff on either STAI (\<30) or PCL-M (\<40)
9. Pregnancy or plans to become pregnant in the next 4 months
10. Excessive levels of physical activity assessed via interview and pedometer recording
11. Current treatment for PTSD (drug or counseling) for a duration of less than eight weeks
12. Clinically judged to be unsuitable for participation by the research physician
EffCaMgCit to Prevent Mineral Metabolism and Renal Complications of Chronic PPI Therapy

Proton pump inhibitors (PPIs) are widely used for the control of gastric ulcer-gastritis, erosive esophagitis (gastroesophageal reflux disease), peptic ulcer disease (duodenal ulcer), and heartburn. Despite their efficacy, their use has been implicated in possibly causing fragility fractures (osteoporosis), hypomagnesemia (magnesium deficiency) and increased risk of chronic kidney disease (CKD). The current trial represents the investigators ongoing effort to discern whether these complications could be averted by effervescent calcium magnesium citrate (EffCaMgCit).

In the current proposal, the investigators wish to conduct a 1-year treatment trial, directed at obtaining more definitive evidence that EffCaMgCit overcomes all three complications of PPI.

Aim 1. To test the hypothesis that EffCaMgCit would prevent/treat osteoporosis, by suppressing parathyroid function and bone resorption, thereby stabilizing bone mineral density (BMD). The critical endpoint will be overall change in BMD T-Score and Z-Score from baseline to the end of study. Secondary endpoints will be the change in serum PTH and C-terminal telopeptide (CTX).

Aim 2. To test the hypothesis that EffCaMgCit would prevent/treat hypomagnesemia/magnesium deficiency, by providing bioavailable magnesium. The critical endpoint will be the overall change in the fractional excretion of magnesium (FEMg) and free muscle magnesium by MRS from baseline to the end of study. Secondary endpoints will be the change in serum and urinary magnesium.

Aim 3. To test the hypothesis that EffCaMgCit would reduce the risk of CKD during PPI use by averting putative hypomagnesemia/magnesium deficiency and neutralizing acid load. The investigators propose that PPI causes hypomagnesemia/magnesium deficiency and confers an acid load, - factors implicated for incident CKD and its progression. EffCaMgCit is expected to avert incident CKD by providing bioavailable magnesium and alkali load. Critical endpoints will be the overall change in endogenous creatinine clearance, urinary alpha-1 microglobulin, and a measure of acid-base status.

Eligibility Criteria:
Inclusion Criteria:

* Ambulatory adult subjects (\> 21 years of age) of either gender of any ethnicity
* Must have taken PPI (omeprazole or equivalent ≥ 20 mg/day, ≥ three times per week, for at least 2 months)
* Expected to continue at a similar dosage
* Stage 1 hypertension (with systolic blood pressure \<140 and diastolic \<90)
* Controlled diabetes mellitus Type II with HbA1C less than 7%

Exclusion Criteria:

* End-stage renal failure on dialysis
* Hypercalcemia,
* Hypophosphatemia (serum P \< 2.5 mg/dL)
* Hypertension stage 2 or higher
* Diabetes Type II with HbA1C ≥ 7%
* Treatment with adrenocorticosteroids, diuretics, non-steroidal anti-inflammatory agents - - Regular dose of magnesium supplements, bisphosphonate, teriparatide, denosumab or selective estrogen receptor modulators
* Required to take calcium

Inclusion/exclusion of other drugs or conditions will be considered on an individual basis.
Laryngomalacia Study

Noisy breathing is commonly caused by a floppy voicebox which is a condition called laryngomalacia. The cause of laryngomalacia is not fully understood, but some studies have suggested that it could be due to acid escaping from the stomach and spreading up the swallowing passage to the throat (acid reflux). This affects about 1 in 100 newborns and is therefore one of the most common reasons for infants to see Otolaryngologists at BC Children's Hospital (BCCH). These infants can have a spectrum of distressing symptoms including squeaky breathing, choking, difficulty feeding, failure to gain weight, and episodes of turning blue (due to lack of oxygen).

At present, Otolaryngologists at BCCH will sometimes give children with laryngomalacia medication to reduce the amount of acid they make in their stomachs, in the hope that this will reduce their symptoms of laryngomalacia. It has never been scientifically confirmed whether anti-reflux medication will benefit these children any more than doing nothing at all.


Eligibility Criteria:
Inclusion Criteria:

* children less than 1 years old
* children determined that they have laryngomalacia at the Pediatric Otolaryngology clinic at BC Children's Hospital.

Exclusion Criteria:Children cannot participate in this study if they have:

* those already on anti-reflux medicine and considered medically unsafe to go through the washout period;
* allergy to the trial medications;
* nasogastric or permanent feeding tube;
* other laryngeal abnormalities.
What Are the Effects of Lower Limb Dysmetria on Gluteus Medius and Erector Spinae Musculature?

Gluteus Medius (GM) has also been implicated in the development of Low Back Pain (LBP). GM is one of the main pelvic, where he actively participates in control of motion in the frontal and transverse plane, and hip , improving stability to the lumbopelvic-hip complex.

The aim of present study was to investigate whether modifying lower limb length with a different foot insoles of 0.5, 1 and 1.5 cm in a normal population has an effect on ES and GM activity and as a consequence in LBP. As a secondary objective, in turn, to evaluate whether ES and GM activity has an effect on jumping ability as assessed through CMJ.

Background: Length leg discrepancy (LLD), regardless of its origin, is a very common pathology that can contribute to low back pain. Various authors point out its relationship with the lack of activation of both the gluteus medius (GM) and the ipsilateral erector spinae (ES). The purpose of this study was to identify the activation of Es and GM with different simulated LLD, correlating said activation with the LBP. In turn, to evaluate whether ES and GM activity has an effect on jumping ability as assessed through CMJ. (2) Method: a sample of healthy subjects was selected to whom an artificial LLD was incorporated through a 0.5, 1 and 1.5 cm insole, measuring with EMGs in these 3 moments while walking and performing a counter movement jump (CMJ). The measurement was carried out in random order, in terms of insole height, using a Latin Square. Muscle activation patterns were recorded for 30 seconds at each of the insole heights while walking at 5.7 km/h and compared with the maximum voluntary contraction (MVC), both on the ipsilateral and contra-lateral sides. These muscles were then measured under the same circumstances during the development of the CMJ. (3)

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* The volunteers had no problems in range of motion of joints of the lower limbs
* pelvic obliquity due to a functional leg length discrepancy.
* obesity with body mass index (BMI) 35 \> kg/m²
STRADIVARIUS (Strategy To Reduce Atherosclerosis Development InVolving Administration of Rimonabant - the Intravascular Ultrasound Study)

The purpose of this study is to determine if rimonabant 20 mg once daily (od) administered during 18-20 months will reduce progression of coronary atherosclerosis as assessed by intravascular ultrasound (IVUS) when administered on top of standard behavioral and pharmacological therapy given as needed, in patients with abdominal obesity associated with current smoking and/or metabolic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Written and signed informed consent
* Indication for coronary angiography
* Abdominal obesity defined by waist circumference \> 88 cm in women or \> 102 cm in men
* At least one of the two following conditions: \*a) Metabolic syndrome as defined by the presence of at least two of the following additional risk factors: 1. Triglyceride level \>= 150 mg/dL (1.69 mmol/L); 2. HDL cholesterol \< 40 mg/dL (1.03 mmol/L) \[men\] or 50 mg/dL (1.28 mmol/L) \[women\]; 3. Fasting glucose \>= 110 mg/dL (6.1 mmol/L); 4. High blood pressure (\>= 140 mmHg systolic and/or \>= 90 mmHg diastolic) at Screening visit, or current treatment by anti-hypertensive medication; \*b) Currently smoking (\> 10 cigarettes /day) and willing to stop
* Angiographic evidence of coronary heart disease as defined by at least 1 lesion in a native coronary artery that has \>= 20% reduction in lumen diameter by angiographic visual estimation
* Presence of at least one coronary artery complying with the definition of "target vessel" for IVUS assessment
* Acceptation of the Baseline IVUS tape by the IVUS Core Laboratory

Exclusion Criteria:

* Age \< 18 years
* Pregnant or breast-feeding women
* History of very low-calorie diet or surgical procedures for weight loss (eg, stomach stapling, bypass) within 6 months prior to screening visit
* Obesity of known endocrine origin
* Uncontrolled diabetes with HBA1c \>10%
* Presence of any severe medical or psychological condition, that in the opinion of the Investigator would compromise the subject's safety or successful participation in the study
* Severe congestive heart failure (New York Heart Association \[NYHA\] Class III or IV)
* Clinically significant heart disease which in the opinion of the Investigator is likely to require coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), cardiac transplantation, surgical repair and/or replacement during the course of the study
* Angioplasty of a non-qualifying artery which is considered at high risk of acute complication or restenosis, during baseline catheterization
* \>50% reduction in lumen diameter of the left main coronary artery by visual angiographic estimation
* Recent ST-elevation myocardial infarction (MI) \<= 72 hours prior to randomization
Stress Reduction for Busy Professionals

This is a pre-post intervention pilot study to evaluate the impact of a 30-minute, 8-week mind-body/meditation intervention on self-reported quality of life in individuals employed by Allina Health. Outcomes will include validated questionnaires for depressive symptomology, perceived stress, anxiety, healthy lifestyle, quality of life as well as biological outcomes of salivary cortisol for a sub-sample of employees.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 to 65 years
* Actively-working healthcare professional employed by Allina Health.

Exclusion Criteria:

* Previous participation in an Allina Health stress reduction program
* Non-English speaking
Fidgeting and Attentional and Emotional Regulation in ADHD

This project will study how fidgeting relates to cognitive and emotional functioning in adults with attention-deficit/hyperactivity disorder (ADHD). It will determine, in a laboratory setting, whether movement and access to a "fidget device" providing sensory and motor stimulation can improve cognitive and emotional regulation (including on physiological measures) in adult ADHD. The investigators will also acquire pilot data for machine learning analyses to be used in future, large scale studies to identify gestures and touch characteristics associated with improved cognitive and emotional regulation to see if the data can predict and subsequently develop recommendations to improve performance and emotional control in natural settings (e.g., home, office, college classroom) for adult ADHD.

Fidgeting is a highly common behavior, with excessive fidgeting associated with attention-deficit/hyperactivity disorder (ADHD). Studies from the investigator's laboratory and colleagues suggest physical movement can enhance cognitive performance in children with ADHD. Hyper-sensorimotor behavior may be related to impaired regulation of arousal in the noradrenergic and dopaminergic systems. This project will assess if frequency and characteristics of sensorimotor behavior relates to cognitive and emotional response in adults with ADHD, in a fine-grained manner, unlike other studies. The investigators will test if intrinsic fidgeting (Aim 1) and access to a specially designed fidget device (Aim 2) modulates behavioral and physiological response in cognitively and emotionally-demanding contexts. The hype of the commercially available fidget devices, its competitors and fidget spinners suggest it might, but there is no systematic evidence to inform consumers, a gap, the investigators aim to fill.

Eligibility Criteria:
Inclusion Criteria:

* ADHD
* History of fidgeting

Exclusion Criteria:

* Currently taking psychoactive medication, with the exception of stimulant medication for ADHD or medication that can affect heart rate;
* Presence of significant depression or psychotic disorders, autism, visual or hearing impairment or any other disorder that may interfere with task performance; and IQ below 85
Observational Study to Evaluate the Safety and Efficacy of Zepzelca™ Injection

The purpose of this study is to evaluate the safety and efficacy of Zepzelca™ inj. in real-world practice and to investigate important identified risks and gaps in information related to risk management plans.


Eligibility Criteria:
Inclusion Criteria:

* Patients who voluntarily provide written consent for personal information collection and utilization after receiving an explanation about the objective and methods of the study
* Patients who have received or are scheduled to receive Zepzelca™ inj., according to domestic approval indications
* Patients with metastatic SCLC who have failed first-line platinum-based chemotherapy

Exclusion Criteria:

* Patients with no prior history of platinum-based anticancer chemotherapy for cancer treatment
* Patients with a history of hypersensitivity reactions to this drug or its components
* Pregnant, potentially pregnant, or lactating women
* Patients currently participating in another clinical trial (drug or medical device) or planning to participate in another clinical trial during the study period (except for non-interventional clinical studies or cases where the clinical trial drug administration has ended and only follow-up is remaining)
* Patients who are judged by the principle Investigator or sub-Investigator to be ineligible to participate in the study.
Effects of Triclosan-coated Sutures in Cardiac Surgery

The purpose of this study is to assess if triclosan-coated sutures reduces wound infections after saphenous vein harvesting in CABG patients. Secondary objectives are the effect triclosan-coated sutures on sternal wound infections and a cost analysis.

The role of the suture material for the development of postoperative wound infection has been debated for many years. It has been reported that fewer bacteria adhere to monofilament polypropylene than braided polyester sutures in vitro but the results are opposed by a non-randomized clinical study where the use of monofilament sutures was identified as an independent risk factor for leg wound infections after CABG.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective CABG at Sahlgrenska University Hospital with intended use of saphenous vein graft are included.

Exclusion Criteria:

* Patients with on-going sepsis or septicaemia, bacterial infections or known allergy to triclosan are excluded.
Immunonutrition and Tolerance to Chemoradiotherapy in Patients With Head-neck Cancer

The aim of the present project is to evaluate in a randomised, controlled, open-label, two parallel treatment groups pilot study, the efficacy of oral nutritional supplementation with a high-protein-high calorie mixture containing immunonutrients compared to a standard high-calorie-high-protein nutritional blend, in addition to nutritional counseling, in improving tolerance to chemoradiotherapy (CT-RT) in patients with tumours of the head and neck

In a recent study, we have shown that the systematic use of oral nutritional supplements (ONS) in combination with counseling further favours the maintenance of nutrition status, the recovery of quality of life and, more importantly, improves the practicability of CT-RT. This effect would be substantially attributable to the increase in protein-energy intake associated with ONS use, but also to the possible "nutraceutical" action of omega-3 fatty acids. Therefore, modulation of the inflammatory response could play a role during cancer treatments. In this context, there is an already-known high-calorie-high-protein nutritional blend, enriched in immunonutrients (arginine, nucleotides and omega-3 fatty acids), which could also have an application in this type of patients. This mixture has proven effective in reducing the risk of post-operative complications (e.g. infections, fistulas, etc.) and the length of stay of patients undergoing major cancer surgery (abdominal and head and neck regions). Nevertheless, in oncology, there is a growing therapeutic interest in the modulation of inflammation and immunosuppression at the tumour microenvironment level.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of head-neck cancer
* indication to curative or adjuvant chemoradiotherapy
* availability to planned measurements and to written informed consent.

Exclusion Criteria:

* age \<18 years
* indication to or ongoing artificial nutrition
* refusal
Flavopiridol in Treating Patients With Recurrent Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma or Mantle Cell Lymphoma

Phase II trial to study the effectiveness of flavopiridol in treating patients with recurrent intermediate-grade or high-grade non-Hodgkin's lymphoma or mantle cell lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

OBJECTIVES:

I. Determine the objective response rate to flavopiridol by patients with previously treated intermediate and high grade non-Hodgkin's lymphoma and mantle cell lymphoma.

II. Determine the toxicity of flavopiridol administered as a continuous infusion every 2 weeks in these patients.

III. Study the pharmacokinetics of flavopiridol in these patients.

OUTLINE: This is an open label, multi-institutional study.

Patients receive treatment on an outpatient basis. Flavopiridol is administered as a continuous infusion over 72 hours every 2 weeks. Patients receive a minimum of 4 cycles of therapy unless unacceptable toxicity or disease progression occurs. Patients are followed until death.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed intermediate or high grade non-Hodgkin's lymphoma (NHL) and mantle cell lymphoma with clinical or pathological evidence of recurrent disease
* Measurable or evaluable disease
* CNS metastases not requiring intravenous steroid therapy allowed

PATIENT CHARACTERISTICS:

* Age: 18 and over
* Performance status: CALGB 0-2
* Life expectancy: At least 12 weeks
* Absolute neutrophil count at least 1500/mm3 (unless due to bone marrow involvement by lymphoma)
* Platelet count at least 100,000/mm3 (unless due to bone marrow involvement by lymphoma)
* At least 7 days since platelet transfusion
* Hemoglobin at least 9.0 g/dL
* Bilirubin no greater than 1.5 mg/dL
* Transaminases no greater than 2.5 times upper limit of normal
* Creatinine no greater than 1.5 mg/dL OR creatinine clearance at least 60 mL/min
* No significant uncontrolled medical or psychiatric illness
* No active serious infection
* Not pregnant or lactating
* Fertile patients must use effective contraception
* Central venous catheter required prior to study entry

PRIOR CONCURRENT THERAPY:

* No more than 1 prior chemotherapy regimen
* At least 4 weeks since prior chemotherapy and recovered from all toxic effects Prior chemotherapy must contain anthracycline if intermediate or high-grade NHL other than mantle cell
* No concurrent treatment with other chemotherapeutic or investigational antineoplastic drugs
* At least 4 weeks since prior radiation therapy and recovered (Site of only measurable disease must not be located within prior radiation therapy port)
* No concurrent radiation therapy to any lesion
Short-term Clinical Feasibility of the Provox XtraHMEs for Pulmonary Rehabilitation After Total Laryngectomy

This study is a short term feasibility study that aims to investigate patient satisfaction with and performance of new Provox Xtra HME in 20 laryngectomized patients. Aspects that are considered are for example performance for stoma occlusion, speaking, breathing, appearance, compliance, and short-term impact on pulmonary symptoms.


Eligibility Criteria:
Inclusion Criteria:

* total laryngectomy
* compliant Provox HME user (24/7 use)

Exclusion Criteria:

* current medical problems that might influence HME use
The Effects of Two Induction Means on Emergence After General Anesthesia

This study aims to investigate the effects of different methods of administration on emergence period after laryngeal mask anesthesia in elderly patients undergoing transurethral endoscopic operation


Eligibility Criteria:
Inclusion Criteria:

* ASA level I or II,
* Aged from 65 to 79,
* With a duration of anesthesia \<90 min.

Exclusion Criteria:

* Chronic obstructive pulmonary diseases (COPD),
* Severe heart disease,
* Difficult airway
* Liver and kidney dysfunction,
* Cerebrovascular disease,
* Bleeding volume \>20 ml.