cyrilzakka/clinical-trials huggingface dataset:
Effect of Vibration Therapy on Bone in Persons With Sub-acute Spinal Cord Injury

The purpose of this research study is to determine the effect of mechanical vibrations on bones of persons with spinal cord injury.

One of the major complications in persons with spinal cord injury (SCI) is marked bone loss because it greatly predisposes to skeletal fractures, even after minimal trauma. The use of low magnitude mechanical stimulation has been shown to be both safe and effective in improving bone mass and strength in animal studies. This modality has also been shown a beneficial effect in children with disability and in postmenopausal women. The investigators are interested in obtaining data to determine the possible benefits that mechanical intervention with vibratory stimulation may have on bone in individuals with subacute SCI (e.g., \>1 month after injury but \<1 year). Changes in bone density and mass of the leg and arm will be determined by dual energy X-ray absorptiometry (DXA); bone architecture of the distal leg and distal arm will be determined by peripheral quantitative computed tomography; circulating metabolic markers of bone will also be performed.

OBJECTIVES

In persons with subacute spinal cord injury:

1. To determine differences in bone mineral mass and parameters of bone structural integrity of the stimulated tibia versus the unstimulated tibia.
2. To determine changes in the metabolic markers of bone resorption and formation in persons with subacute spinal cord injury.

Eligibility Criteria:
Inclusion Criteria:

1. Males;
2. Age 18-65;
3. Non-ambulatory SCI, with ASIA level A or B (ASIA A or B at the time of enrollment);
4. Neurological level of injury C3-T10;
5. Duration of injury \>1 month after injury but \<1 year; and 6.25(OH)D levels 30ng/ml (patients with values \<30ng/ml will be supplemented with vitamin D to normalize values prior to study participation).

Exclusion Criteria:

1. Osteoporosis or low bone mass as determined by medical history or DXA at the baseline visit;
2. Pressure ulcer that may be exacerbated by the experimental procedure;
3. Fracture of the lower extremity within the past 5 years;
4. Active heterotopic ossification (HO);
5. History of metabolic bone disease;
6. Knee replacement(s);
7. Metal hardware in the lower extremities;
8. Bisphosphonate administration;
9. Severe underlying chronic illness (cardiac, pulmonary, gastrointestinal, etc.);
10. Renal disease (creatinine clearance \< 40 mL/min);
11. 25(OH)D levels \<30ng/ml;
12. Endocrine disorders known to be associated with osteoporosis (hyperthyroidism, hypercortisolism, and/or hypogonadism);
13. Alcoholism;
14. Seizure disorders;
15. History of kidney stones; and
16. Compliance 85% for every month up to the 4-month time-point
Effect of CBT Microinterventions on Mechanisms of Behavior Change Among Adults With AUD

This proposed R21, Effect of CBT Microinterventions on Mechanisms of Behavior Change among Adults with AUD: Using Eye Tracking to Measure Pre-Post Cognitive Control, uses a translational team science approach to isolate and examine the effect of three different Cognitive Behavioral Therapy (CBT) interventions (functional analysis (FA), cognitive restructuring for alcohol related thoughts (CR), and dealing with cravings (DC)) on specific hypothesized mechanisms (cognitive control, stimulus salience, or craving/arousal, respectively).

This R21 uses an innovative paradigm pairing a "microintervention" design with eye tracking laboratory tasks used successfully to show deficits of cognitive control over cocaine and nicotine cues, and to objectively measure stimulus salience and craving/arousal in response to alcohol cues. To achieve the study's two specific aims, participants with AUD will be assessed with antisaccade (to measure cognitive control) and attentional bias (to measure stimulus salience and pupil diameter) eye tracking tasks.

Specific Aim 1. To isolate and preliminarily assess the impact of specific CBT microinterventions on potentially malleable hypothesized mechanisms of change in drinking using a novel laboratory paradigm and conducted by a translational science team.

Specific Aim 2. To test specificity of CBT interventions' effect on particular Mechanisms of Behavioral Change, the investigators will test each microintervention's effects on all three purported mechanisms (as stated in "Brief Summary".)

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Current Alcohol Use Disorder (AUD) Diagnosis
* Drank Alcohol within 60 days prior to telephone screen
* Able to read and understand English at the 7th grade education level

Exclusion Criteria:

* Participant diagnosed with Schizophrenia or Schizoaffective Disorder
* Participant has a head injury with symptoms in the last 30 days
* Current inpatient or outpatient treatment for AUD or Drug use Disorder (DUD)
Pediatric Liver Fat Quantification (LFQ) Phase 2 Pilot Study

This clinical study will involve performing a series of medical imaging procedures of the abdomen using both ultrasound and MRI modalities in subjects at risk for or already diagnosed with Nonalcoholic Fatty Liver Disease (NAFLD). The primary objective of this clinical study is to evaluate the clinical feasibility of an investigational ultrasound technique for quantifying liver fat by comparing specific ultrasound-derived biomarkers with the liver fat percentage obtained from MRI Proton Density Fat Fraction (MRI-PDFF) measurements. All subjects enrolled in this study will undergo one investigational abdominal ultrasound examination using the Philips EPIQ Ultrasound System and one MRI PDFF examination according to the clinical standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Subjects at least 5 years old up through and including 21 years old who are able to provide informed consent to participate or have a legal representative/parent/legal guardian who is able to provide informed consent for the subject to participate.
* Subjects must be eligible for a standard abdominal ultrasound examination and standard non-contrast MRI examination.

In addition, at least one of the following criteria must also be met:

* Overweight or obese (BMI-for-age ≥ 85th percentile).
* Diagnosed with Type 2 diabetes per standard clinical guidelines.
* Diagnosed with hypercholesterolemia per standard clinical guidelines.
* Diagnosed with or clinically suspected of having NAFLD/NASH based on previous medical record, medical imaging, liver biopsy, and/or laboratory testing.

Exclusion Criteria:

* History of moderate/heavy/binge alcohol consumption exceeding NIAAA guidelines.
* Evidence of hepatotoxicity or cirrhosis in the clinical judgment of the investigator.
* History of chronic liver disease other than NAFLD (e.g., viral, cholestatic, or autoimmune).
* Use of drugs associated with hepatic steatosis:

  * Amiodarone
  * Methotrexate
  * Nucleoside reverse transcriptase inhibitors (didanosine, stavudine)
  * Valproic acid
  * Dexamethasone
  * Tamoxifen
  * 5-FU-based adjuvant chemotherapy
  * Apo-B inhibitors (mipomersen, lomitapide)
  * Tetracycline exceeding 2 g/day
  * Acetylsalicylic acid exceeding 150 mg/kg
Evaluating the Role of Cystatin C and Creatinine as Markers of Renal Recovery in Critically Ill Patients After Acute Kidney Injury.

This is a cohort study in which patients who survive Acute Kidney Injury (AKI) during intensive care unit (ICU) admission are recalled at 3-6 months and renal function tests are performed.

The purpose of the study is describe renal function in AKI survivors at follow-up.

Additional aims are to determine how well admission values of renal function markers perform as predictors of renal function at follow-up and whether estimates of renal function at follow-up differ depending on which renal function marker is used.

Type of study: Cohort study with prospectively collected clinical data cross-matched with local \& national databases.

Source population: Patients suffering from AKI on a mixed intensive care unit, at the Karolinska University Hospital, Solna.

Setting: Single centre, Central Intensive Care unit Karolinska University hospital, Solna, Stockholm from September 2008 and May 2011.

Exposure: AKI on ICU and grade of AKI according to the RIFLE criteria Intervention: none

Outcome: Renal function 3 months after ICU discharge according to creatinine and Cystatin C measurements.

Parameters: Co-morbidities, ICU diagnoses, disease severity score, daily physiological and laboratory parameters, medications administered, interventions RRT (Renal replacement therapy), mechanical intervention, inotropes, surgery.

Data is crossmatched with national registries including the Swedish cause of death register (to obtain dates of death), the Swedish renal register (to obtain details of patients receiving chronic dialysis and with pre-existing Chronic Kidney Disease (CKD) diagnoses. Data is also cross matched with a large local ICU register (Clinisoft) to obtain physiological parameters\& intervention details. Clinisoft is also used to obtain risk of death for all ICU patients and all AKI patients (from the source population). Ethical approval has been granted by Stockholm Regional ethical review body (2008-408-32 2008/443-31/1-3, 2010/1780-31-2, 2011-408-32 and 2016-1801-32).

Aims:

1. Describe the incidence of renal dysfunction in terms of Glomerular filtration rate (GFR) under 60ml/min/173m² at 3-6 months follow-up after AKI. According to serum Cystatin C and Creatinine values.
2. Describe the incidence of Acute Kidney Disease (AKD) at 3 month follow-up.
3. Produce a predictive model using comorbidities and admission data to CKD (Chronic Kidney Disease) and AKD 3-6 after AKI in intensive care patients.
4. Examine how estimated GFR using creatinine and Cystatin C differ from measured Iohexol GFR at 6 month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Adults treated on Intensive care with AKI (RIFLE criteria)
* Survival 3 months after discharge.
* Admission during September 2008-May 2011

Exclusion Criteria:

* Under 18 years
* Unable to give consent.
* Admission during a time when study staff not working.
* Death before 3 month follow-up
* No Swedish personal identification number
A Social Media Intervention for Risky Drinking

This study is being completed to pilot prevention methods to promote wellness and reduce risky behaviors, including the use of substances such as alcohol and other drugs. This study will help the study team learn about ways of delivering this information that is both appealing and helpful to young adults.


Eligibility Criteria:
Inclusion Criteria:

* Reside in the United States of America (USA)
* Be able to read English, view, and click on a social media advertisement.
* Self-reported past-month high-intensity drinking (HID)
* Regular Snapchat use (at least 3 days/week).

Exclusion Criteria:

* If they fail identity verification based on: 1) internet protocol address (IP), 2) survey time completion, 3) repeat attempts, and 4) survey responses.
Evaluation of Peripheral Blood Protein Biomarkers for Colorectal Cancer Screening

The aim of the study is to validate the value of value of peripheral blood protein biomarkers in colorectal cancer screening, and to identify new ones


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 50 years or older referred for screening colonoscopy after a positive FIT test or for endoscopic resection of a previously identified suspicious colorectal lesion

Exclusion Criteria:

* Very high risk of colorectal cancer: Lynch syndrome, Familial adenomatous polyposis, Peutz-Jeghers syndrome, Familial polyposis associated with a MutYH gene defect
* Other solid cancers or haematological malignancies that are progressive and/or undergoing treatment (apart from basal cell skin carcinoma)
* Contraindication to total colonoscopy
Self-Criticism Feasibility Study

This uncontrolled pilot seeks to develop a novel intervention based on Compassion Focused Therapy (CFT), that reduces self-criticism and improves psychological wellbeing. The researchers aim to assess the the acceptability and feasibility of providing such an intervention within a primary mental health care service; and a preliminary indication of the the effectiveness of this intervention?

The intervention is based upon recent unpublished doctoral research that developed this novel treatment within students with high levels of self-criticism. This pilot study aims to adapt the intervention for an Improving Access to Psychological Therapies (IAPT) service, a primary mental-health service in the UK.

Self-criticism is a transdiagnostic process across common mental-health disorders and is therefore, a potential target for psychological intervention. Clients at IAPT are likely to present with high levels of self-criticism. This pilot study may help develop an alternative evidence-based intervention that can be routinely offered within IAPT services.

The researchers aim to recruit 20 clients registered at Talking Therapies Southwark, experiencing a significant impact of self-criticism on their daily life, and requesting help for self-criticism. Clients that provide consent to participate in this study would receive 6 sessions of this intervention and a 2-month follow-up telephone session.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent
2. Registered with and opt into the Southwark IAPT service, Talking Therapies Southwark
3. Score at least 10 on the WSAS questionnaire regarding the impact of self-criticism on their daily life
4. Requesting help for their self-criticism.

Exclusion Criteria:

1. Not being sufficiently proficient in English to fully participate in the sessions with English-speaking therapists or process the written study materials for any reason.
2. Being unable to attend six sessions of assessment/treatment.
3. Presenting with high levels of risk requiring monitoring and assistance beyond the weekly intervention focusing on self-criticism.
4. Current serious mental health problem such as bipolar disorder, anorexia nervosa or a moderate / severe substance use disorder.
5. Cognitive impairment or psychomotor retardation of a degree that would prevent completion of the study treatment protocol with the individual. This would be based on a clinical judgement by potential referrers or by the clinician undertaking the screening assessment.
6. Currently experiencing a degree of life stress (e.g. recent bereavement) that is judged by the assessor to be likely to seriously adversely affect their ability to benefit from the intervention
7. New pharmacological interventions for psychological distress - i.e. a change of medication or dosage in the last 4 weeks.
8. Current participation in another clinical (talking therapy or drug) trial or another psychological intervention.
Modified "Providence" Pedi Cast-Sling vs.Cast and Sling

Examining custom made sling vs. off the shelf sling for immobilization following pediatric upper extremity fractures.


Eligibility Criteria:
Inclusion Criteria:

* patients aged 0-18 years old who were evaluated in the pediatric emergency department (ED) by the orthopaedic resident on call
* patients with an upper extremity fracture (wrist, forearm or elbow) that required placement of a long-arm cast.

Exclusion Criteria:

* open fractures
* fractures at multiple levels (e.g. wrist AND elbow fracture)
* fractures requiring immediate/urgent surgery
* patients requiring admission for any reason
* bivalved LAC's for any reason
Study on Gene Evolution in Glioma Under Stress Therapy

Little is known about the evolution of genetic and epigenetic changes that occur in the progression of glioma. We inferred the evolution trajectories of matched pairs of primary tumors and progression tumor in situ fluid (TISF) based on deep whole-genome-sequencing data (ctDNA). A monocentric, Gene grouping controlled trial design was used to select patients. and to compare gene evolution of different subtypes of glioma under therapy. To predict the molecular reaction of bevacizumab treatment, clarify the mechanism of drug resistance of bevacizumab treatment.

Patient: Adult glioma, pathological diagnosis combined with molecular diagnosis (i.e. IDH- mutant glioma, IDH- mutant glioma with 1p/19q- co-deletion, glioblastoma). The patients were divided into three groups: group A (IDH mutant glioma), group B (IDH mutant with 1p/19q co-deletion oligodendroglioma ) and group C (IDH wild glioblastoma). From the first day after surgery, the ctDNA was extracted with TISF before concurrent chemoradiotherapy as the baseline, and the ctDNA was detected again after concurrent chemoradiotherapy. For the third time, ctDNA was detected in temozolomide intensive chemotherapy. ctDNA was detected for the fourth time when the image showed tumor progression. After the progress, temozolomide combined with bevacizumab was used for chemotherapy. ctDNA was detected 6 weeks after the application of bevacizumab, and ctDNA was re-measured every 6 weeks during the treatment of bevacizumab. At the same time, imaging examination was performed to determine the tumor progress. Check and record adverse events and drug use in detail, and evaluate the compliance of subjects; After TISF tissue extraction, the retained blood samples were sent to simcere Company and Beijing Genetron Health Technology Co. Ltd for ctDNA quantification and detection. To study the differences of gene evolution of different subtypes of glioma under pressure therapy, to clarify the differences of molecular responses of different subtypes of glioma to bevacizumab, and to evaluate the therapeutic effect and safety.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 75 years, both male and female (including 18 and 75 years old) glioma;
* Willing to accept treatment and sign informed consent.

Exclusion Criteria:

* Participants with other infection disease or immunodeficiency disease;
* other central infectious diseases;
* malignant tumor of non-nervous system;
* drug abuse;
* severe psychiatric disease;
* uncontrolled diabetes;
AZD1722 Open Label, Absorption Distribution Metabolism and Excretion Study

To assess the absorption, distribution, metabolism and excretion of a single dose of 14C labelled AZD1722 in order to define the rates and routes of elimination of AZD1722 and if formed, metabolites.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers aged ≥50 years
* Regular daily bowel movements.
* Have a body mass index (BMI) between 18 and 32 kg/m2 (inclusive) and weigh at least 50 kg and no more than 110 kg.

Exclusion Criteria:

* History of any clinically significant disease or disorder which, in the opinion of the Principal Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study.
* History or presence of GI, hepatic or renal disease including GI surgery other than appendectomy or any other condition known to interfere with the ADME of drugs.
* Loose stools (Bristol Stool Form Score of 6 or 7) ≥2 days in the past 7 days before admission to the study centre
* Use of medications that are known to affect stool consistency and/or GI motility, including fibre supplements, anti-diarrheals, prokinetic drugs, enemas, probiotic medications or supplements; or salt or electrolyte supplements containing sodium, potassium, chloride, or bicarbonate formulations during the past 7 days before admission to the study centre.
* Volunteers exposed to radiation levels above background (eg, via X-ray examination) of \>5 mSv in the last year, \>10 mSv over the last 5 years or a cumulative total of \>1 mSv per year of life.
* Participation in a previously radiolabelled study within the last 5 years
The Effect of Respiratory Muscle Warm-up on Pulmonary Diffusion Capacity in Athletes

Several studies suggest that inspiratory muscle warm-up (IMW) could potentially affect exercise performance; however, its mechanistic basis is still unclear. The aim of this study was to examine the effect of IMW on lung diffusing capacity for carbon monoxide, cardiorespiratory, perceptual and performance outcomes in elite athletes from different disciplines.

The aim of this study is to evaluate the effects of IMW on diffusion capacity for carbon monoxide, cardiorespiratory, perceptual and performance outcomes during high-intensity exercise in elite athletes from different disciplines. The study will be conducted using a randomized, placebo-controlled, double-blind and crossover study experimental design involving 35 athletes from various sports disciplines, including endurance, strength, skill-based, and mixed disciplines.

Participants will attend the laboratory on four separate occasions. During the first visit, they will be informed about the study and familiarized with the application and measurement procedures. In the second visit, a general warm-up will be performed. During the third and fourth visits, IMW (IMW40% or IMW placebo) protocols will be applied in addition to the general warm-up. Measurements of DLCO, pulmonary function tests, respiratory muscle strength, and gas analysis during maximal aerobic exercise will be collected both before and after the warm-up protocols.

A. STUDY DESING This study will employ a placebo-controlled, randomized, crossover, and double-blind research design to evaluate the effects of three warm-up conditions: Control, Placebo 15%, and IMW 40%. Athletes will be randomly assigned to the conditions using a crossover approach, ensuring that all participants will experience each protocol on separate days.

The warm-up protocols will include:

General Warm-up (Control): A standard warm-up without resistance. IMW 40%: A general warm-up combined with respiratory muscle exercise at 40% resistance.

Placebo 15%: A general warm-up combined with placebo respiratory muscle exercise at 15% resistance.

Blinding will be maintained for both participants and researchers. Participants will be informed that the study aims to investigate various warm-up types, while the true purpose will remain concealed. This design will ensure reliability and minimize bias in the data to be collected.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-24 years.
* A training history of at least six years.
* Regular training frequency of at least four sessions per week.

Exclusion Criteria:

* History of smoking.
* History of physical disability or acute respiratory or cardiovascular disease within the past three months.
* Diagnosis of SARS-CoV-2 within the past three months.
* Pulmonary function measurements outside the normal clinical range (≤ 80%).
A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD)

This is an outpatient, 2-arm, Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of REL-1017 once daily (QD) as an adjunctive treatment of Major Depressive Disorder. Study participants will continue to take their current antidepressant therapy in addition to the study drug or placebo for the duration of the treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 18.0 and 35.0 kg/m2.
* Diagnosed with Major Depressive Disorder (MDD) based on Structured Clinical Interview for DSM-5 (SCID-5) for MDD.
* Current Major Depressive Episode (MDE).
* Treated on approved, stable first-line anti-depressant therapy with inadequate response to 1 to 3 valid courses of treatment with a depressant medication in the current MDE.

Exclusion Criteria:

* Any current and primary psychiatric disorder other than Major Depressive Disorder.
* Severe alcohol or substance use disorder.
* History of bipolar I and II disorder, psychosis, and/or mania.
* Poorly controlled diabetes as defined by HbA1c \> 7.5%, despite standard care. Subjects with HbA1c \>7.5% may continue in the study if approved by the Relmada Medical Monitor.
* Having received ketamine or esketamine within 60 days prior to Screening.