cyrilzakka/clinical-trials huggingface dataset:
Effect of LASER Photobiomodulation Therapy on Chronic Pain and Opioid Weaning

This study will examine the effect of LASER photobiomodulation therapy on pain and opioid pain medication weaning on patients who are undergoing opioid pain medication weaning.

The primary objective of this study is to determine if treatment with LASER photobiomodulation therapy reduces pain and facilitates opioid pain medication (OPM) reduction (weaning). The subject group includes patients with chronic pain who are undergoing OPM weaning and are candidates for LASER photobiomodulation therapy. This is a prospective interventional study using a double-blind 4-period crossover design to assess the efficacy of HIGH POWER LASER photobiomodulation therapy compared to sham (LOW POWER LASER) therapy in reducing pain and improving compliance with OPM weaning.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older.
* Taking prescribed opioid pain medications in an amount in excess of 30 Morphine Equivalent Dose (MED) for 6 months or longer.
* Have been recommended to wean or reduce their MED.
* Medically stable such that subject does not have unstable angina, COPD requiring supplemental oxygen, untreated or active cancer or similar conditions that would make participation difficult or unsafe.
* Compliant with all physician recommendations relating to medication usage.
* Ambulatory and able to use the toilet independently.
* Negative pregnancy test in subjects of childbearing potential
* Willing to attempt opioid pain medication taper.
* Competent to provide informed consent.
* Capable of understanding and completing study questionnaires.
* Subject willing to participate in the study for up to 12 weeks.

Exclusion Criteria:

* Not capable of understanding or completing study questionnaires.
* Lacking capacity to provide fully informed consent.
* Substance use disorder not in remission.
* Considering surgery or other invasive procedures that would take place during the study.
* Used isotretinoin (Accutane) within 6 months prior to study enrollment
* Cancer not in remission.
* Need of ongoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy, massage therapy, chiropractic care or other treatments intended to remediate pain other than treatment in the Sharp Pain Program.
* A female who is pregnant or lactating, or of childbearing potential unless a medically acceptable method of birth control is in use.
* Any use of light-activated drugs (photodynamic therapy) or heat sensitive medications within 30 days of first treatment.
* Used an investigational drug/device therapy or participated in any clinical investigation relating to pain within 4 weeks prior to study enrollment.
* A psychiatric or psychological condition that would place undo stress on the subject, prevent full participation or compromise data collection.
* The subject is otherwise determined, based on the opinion of the Investigator, to be an unsuitable candidate for enrollment in this study
Study to Define Optimal IGF-1 Monitoring in Children Treated With NutropinAq

The main purpose of this study is to establish an optimal monitoring regimen in NutropinAq treated children, using newly developed capillary blood spot IGF-1 measurement technology.


Eligibility Criteria:
Inclusion Criteria:

* Children under 18 with growth failure associated with inadequate growth hormone secretion, or Turner syndrome or chronic renal insufficiency.

Exclusion Criteria:

* Children with closed epiphyses
* Children with active neoplasm
* Children with acute critical illness
The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure

Coronavirus disease (COVID-19) can result in severe hypoxemic respiratory failure that ultimately may require invasive mechanical ventilation in the Intensive Care Unit (ICU). Although lifesaving, invasive mechanical ventilation is associated with high mortality, severe discomfort for patient, long-term sequelae, stress to loved-ones and high costs for society. During the ongoing pandemic high number of invasively ventilated COVID-19 patients overwhelmed ICU capacity.

Non-invasive respiratory support, such as high flow nasal oxygen (HFNO) or non-invasive ventilation (NIV) have the potential to reduce the risk for invasive mechanical ventilation and in selected cases ICU admission. However, data from different studies are conflicting and studies performed in COVID-19 patients are of limited quality. Furthermore, identification of early predictors of HFNO/NIV treatment failure may prevent unnecessary delay of initiation of invasive ventilation, which may be associated with adverse clinical outcome. The development and validation of a prediction model, that incorporates readily available clinically data may prove pivotal to fine-tune non-invasive respiratory support.

The overall aim of the NORMO2 project is to investigate the role and risks of HFNO and NIV to improve outcome in hospitalized hypoxemic COVID-19 patients.


Eligibility Criteria:
Inclusion Criteria:

* Sars-Cov-2 infection
* hospital admission (emergency department, inpatient or ICU)
* hypoxemic respiratory failure, defined as P/F ratio below or including 200

Exclusion Criteria:

* hypercapnia (PCO2 \> 45 mmHG in combination with acidemia (pH \< 7.35))
* pregnancy
* do not resuscitate order
A Study to Evaluate AP-101 in Familial and Sporadic Amyotrophic Lateral Sclerosis (ALS)

Single ascending doses of AP-101 will be administered by intravenous (IV) infusion


Eligibility Criteria:
Inclusion Criteria:

* All participants must adhere to contraception restrictions
* Female patients of non-childbearing potential due to:

  1. Menopause: spontaneous amenorrhea for at least 12 months not induced by a medical conditions such as anorexia nervosa and not taking medications that induced the amenorrhea (e.g., oral contraceptives, hormones, gonadotropin releasing hormones, anti-estrogens, selective estrogen receptor modulators, or chemotherapy)
  2. Surgical sterilization
* Have possible, probable, probable laboratory supported or definite and definite familial laboratory-supported ALS in accordance with the El-Escorial criteria
* Have familial or sporadic ALS.
* With onset of ALS symptoms, specifically onset of muscle weakness within past 48 months
* Have slow vital capacity (SVC) of (greater than or equal to) ≥60%
* If on riluzole, must be on a stable dose
* If on edaravone, must have completed 2 cycles and are expected to remain on the same dose throughout the study
* Able to provide informed consent. If the patient is not able to provide written consent due to aggravation of disease condition, written informed consent may be provided by a legally authorized representative
* Have venous access sufficient to allow for blood sampling
* Have clinical laboratory test results within normal reference range for the population or study site, or results with acceptable deviations that are judged to be not clinically significant

Exclusion Criteria:

* Are currently enrolled in, or discontinued from, within the last 30 days, a clinical trial involving an investigational drug or device or off-label use of a drug or device, or any other type of medical research judged not to be scientifically or medically compatible with this study
* Have previously completed or withdrawn from this study
* Have a history or presence of medical illness including, but not limited to, any cognitive, cardiovascular, hepatic, hematological, renal, endocrine, or psychiatric, or any clinically significant laboratory abnormality that indicates a medical problem that would preclude study participation
* Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
* Show evidence of hepatitis C and/or positive hepatitis C antibody
* Show evidence of hepatitis B and/or positive hepatitis B surface antigen
* Are women who are lactating.
* Have undergone a tracheostomy unless it was removed at least 6 months prior
* Are on feeding tube, unless the insertion of a feeding tube is considered prophylactic
* Are on nasal intermittent positive pressure ventilation (NIPPV) \>4 hours per day or at the discretion of the medical monitor
* Have undergone stem cell therapy
Percutaneous Kyphoplasty Using Rotary Cutter in Osteoporotic Vertebral Fractures

Kyphoplasty(PKP) is performed under general anaesthesia in patients with osteoporotic vertebral compression fracture. The balloon is first placed into the fractured vertebra and inflated with contrast agent for height restoration. Then, the cement is injected into the cavity created by the balloon. As the diffusion of cement can be interfered by closely barriers formed by surrounding cancellous bones, refractures are often found in patients with conventional PKP. Furthermore, the loss of restored height of surgical vertebrae due to refracture in PKP. The investigators will applied a rotary cutter to destroy the structure of the cavity created by the balloon. Finally, the cement is injected, which may effectively interdigitates with the surrounding cancellous bone.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is able to undergo the vertebroplasty or balloon kyphoplasty procedure
2. Patient has read and sign the informed consent
3. Male or female, 50 years or older
4. Compressive and burst vertebral body fractures without any neurological deficit.
5. Persistent pain despite medical treatment according to VAS ≥ 5 or a last resort to morphine treatment

Exclusion Criteria:

1. Neurological signs related to the vertebral fracture to treat
2. Unmanageable bleeding disorder
3. History of surgical or percutaneous spine treatment except simple discectomy at a single or multiple vertebral levels with no residual pain.
4. Known allergy to bone cement
5. Local or generalized infection
6. Improvement of the symptoms of the patient with conservative management
The Effect of 1L Polyethylene Glycol Plus Ascorbic Acid With Prepackaged Low-Residue Diet for Bowel Preparation

Background 2L polyethylene glycol plus ascorbic acid (PEGA) is known to be as effective as standard 4L polyethylene glycol for bowel preparation. However, the volume of this regimen is still large. Therefore, the present investigators evaluated the potential of 1L PEGA with prepackaged low-residue diet (PLD) for an alternative to 2L PEGA.

Aim: To evaluate efficacy of 1L PEG with ascorbic acid combined with prepackaged low-residue diet as bowel preparation for colonoscopy.

Methods: The subjects were randomly assigned to either groups. PEGA group received 2L PEGA split regimen. PLD group received PLD on the day preceding colonoscopy and 1L PEGA on the morning of colonoscopy. One blinded physician performed colonoscopy and evaluated the degree of bowel preparation using Boston bowel preparation score (BBPS). A questionnaire regarding tolerability and safety were also gathered.


Eligibility Criteria:
Inclusion Criteria:

* anyone who were scheduled for an outpatient colonoscopy below indication

  1. patient who need colonic polyp screening
  2. patient who have hematochezia
  3. patient who have fecal occult blood test positive result

Exclusion Criteria:

* ileus
* inflammatory bowel disease-
* gastrointestinal malignancy
* severe cardiac disease (heart failure beyond NYHA Class III)
* chronic obstructive pulmonary disease,
* decompensated liver cirrhosis; coagulopathy
* Female patients with pregnant or breastfeeding.
* who use long-term use of sedative, anti-spasmodic, prokinetic, laxative or anti-diarrheal medications
Safety Study of Mini-dystrophin Gene to Treat Duchenne Muscular Dystrophy

The purpose of this study is to determine the safety of a miniature dystrophin gene in the treatment of progressive muscle weakness due to Duchenne Muscular Dystrophy (DMD).

This phase I randomized double blind dose escalation study investigates the safety and efficacy of the mini-dystrophin gene transferred to the biceps muscle for Duchenne muscular dystrophy patients, ages 5 to 12 years of age, using a recombinant adeno-associated virus. Eligible participants must have a known dystrophin gene mutation and may be concurrently treated with corticoid steroids. The mini-dystrophin gene or a placebo agent (normal saline or empty viral capsids) are injected directly into both biceps muscles while under conscious sedation. Following the gene transfer, patients are admitted to the hospital for 48 hours of observation followed by weekly outpatient visits at the Columbus Children's Hospital Neuromuscular Clinic. A bilateral muscle biopsy is preformed following 6 weeks with long term follow up will consisting of bi-annual visits for the next 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Known null mutation of the Dystrophin gene
* Male age of 5 years or older
* If taking corticosteroids, must have dose unchanged for the past 3 months
* Serum creatine kinase elevation greater than 10x normal value (established by Children's Hospital)
* Progressive, symmetrical proximal muscle weakness of arms and legs

Exclusion Criteria:

* Unable to cooperate for muscle strength testing
* Joint contractures that prohibit muscle strength testing
* Concomitant illness
* Individuals predisposed to excessive vagal responses (bradyarrhythmia or hypotension)
* Controlled substance abuse
Measurement of Tissue Oxygen Saturation in Chronic Critical Limb Ischemia

Near-infrared spectroscopy can be used to determine the relative oxygen saturation in tissues up to 2cm below the skin. It has been investigated, with success, in cerebral, gastrointestinal, and muscle tissue, and shows promise in numerous indications involving tissue ischemia. In the current study, we propose to examine one hundred patients requiring either bypass or angioplasty due to chronic critical limb ischemia resulting from peripheral arterial disease. We intend to challenge patients before and after the intervention, using either an inflated blood pressure cuff or toe raises, to determine if oxygen saturation recovery time in the affected limb is correlated with symptom resolution (i.e. treatment success). Near-infrared spectroscopy will be performed using the ODISsey tissue oximeter developed by ViOptix, Inc. The proposed study will take approximately one year to complete enrolment, and has a follow-up period of 6 months post-intervention.

Study Hypothesis: Knowledge of tissue oxygen saturation enhances clinical decision making in patients with chronic critical limb ischemia.


Eligibility Criteria:
Inclusion Criteria:

* \>= 18 years old
* PAD
* Chronic Critical Limb Ischemia
* requiring surgical intervention
* able to give informed consent

Exclusion Criteria:

* emergent/urgent requirement for surgical intervention
* requiring surgical intervention due to acute traumatic injury
Walking Exercise on Memory, Subjective Cognitive Complaint, and Brain-derived Neurotrophic Factor for Hypertension

The purpose of this study is to determine the effect of 6-month aerobic walking program on memory, subjective cognitive complaints, and brain-derived neurotrophic factor for older hypertensive women. Participants will be randomly assigned to the experimental group and the control group. The intervention group will last for 24 weeks. The outcome measurements included memory, subjective cognitive complaints, and brain-derived neurotrophic factor.

The purpose of this study is to explore an aerobic walking program on memory, subjective cognitive complaints, and brain-derived neurotrophic factor. In quantitative study with experimental design, qualified subjects will be randomly assigned to experimental or control group. Experimental subjects will perform six-month aerobic walking program and control group receive routine care. The outcome measurements included memory, subjective cognitive complaints, and brain-derived neurotrophic factor. Data will be collected at baseline, the end of the six-month intervention. Data will be analyzed using Generalized Estimation Equation evaluate the effect of the intervention program.

Eligibility Criteria:
Inclusion Criteria:

1. aged 60-80 years old,
2. a diagnosed of hypertension ≥ 6 months
3. self-reporting the signs of memory or thinking skills problems

Exclusion Criteria:

1. probable cognitive impairment as assessed by Montreal Cognitive Assessment ( \< 24 points),
2. significant conditions limiting walking ability (e.g. musculoskeletal problems, visual impairment, etc.),
3. already participating in 30 minutes or more of moderate-intensity exercise five times a week
4. a history of severe cardiovascular disease,
5. a history of neurologic or psychiatric disorder such as stroke, head injury dementia, Parkinson disease, and depression.
Audio Distraction for Traction Pin Placement

Traction pin placement is a common way to temporarily manage femur fractures and unstable acetabular fractures while awaiting surgery. Skeletal traction is thought to reduce patient discomfort by improving fracture alignment as well as relaxing muscle spasm pain felt from the broken bone by stretching out the leg. Skeletal traction may also help prevent articular surface damage in the hip by decreasing joint pressure. Despite the benefits of skeletal traction, insertion of the traction pin can be a painful and unpleasant experience for the patient. Our study hopes to see if listening to music with headphones during insertion of the traction pin decrease patient pain and anxiety.

Given that skeletal traction is the current standard of care at our institution; our study will focus on the use of audio distraction during placement of skeletal traction and the effect on patient discomfort. There have been multiple studies examining the use of various distraction techniques for pain and anxiety, mainly with patients undergoing GI procedures, such as colonoscopy. The goal of our study is to investigate the use audio distraction with music from an mp3 player and headphones, and the effect on patient anxiety and pain during the placement of a skeletal traction pin. Provider-perceived patient cooperation and procedure difficulty will also be assessed.

This is a prospective randomized controlled trial at Regions Hospital in Saint Paul, MN and Jackson Memorial Hospital in Miami, Florida to compare primary outcomes of subjects between audio distraction and no audio distraction groups during traction pin placement. Recruitment of patients for inclusion in this study will be completed by the orthopedic resident placing the skeletal traction pin. Patients will be recruited for inclusion in this study after determining the medical need for placement of a skeletal traction pin. Routine care will be provided by the orthopedic resident for skeletal traction pin placement. Those included in this study and randomized into the treatment arm will be given an mp3 device and headphones to listen to a genre of music of their choosing in addition to being treated to the current routine care. Those randomized into the control arm will be treated to the current routine care without any use of music. Patients will be randomized into 2 groups; audio distraction with music versus control group with no music.

Eligibility Criteria:
Inclusion Criteria:

* Conscious, oriented, able to give informed consent
* Medical need for distal femoral or proximal tibial skeletal traction pin placement

Exclusion Criteria:

* Medical contraindication to skeletal traction
* Endotracheal intubation
* Unable to participate in verbal communication throughout the procedure and in the recovery phase
* Sensory impairment to pain
* Inability to make accurate mark on VAS 2/2 cognitive, motor or visual deficiencies.
Randomized Study on Adjuvant Chemotherapy and Adjuvant Chemo-Immunotherapy in Colon Carcinoma Dukes C

This clinical investigation examined the effectivity 5-fluorouracil, of adding levamisol or interferon to 5-fluorouracil, and of a 5-fluorouracil/levamisol/interferon triple combination, in terms of recurrence-free and overall survival in curatively operable colon carcinoma Stage III.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically verified, curatively operated colon carcinoma Stage III (R0, T1-4, N1-3, M0)
* Age: less than 80 years
* WHO Performace Status \> 2
* Adequate bone marrow reserve
* Informed consent

Exclusion Criteria:

* Rectal cancer
* R1, R2, carcinosis peritonei
* Start of chemo- or chemo-immunotherapy \> 42 days postop; other adjuvant radiotherapy, chemotherapy or immunotherapy
* Serious concomitant disease, in particular chronically inflammatory large intestine, cardiopathic disease, malignant second carcinoma
Brain Changes During Social Reward Psychotherapy for Mid- and Late-Life Suicidality

The investigators hypothesized that during the 9-week course of Engage \& Connect treatment there will be an increase in brain functions of the Positive Valence System which in turn will lead to reduction in suicidality.

Social disconnection peaks in middle and late life and leads to an increased risk of suicide, persistent depression, and poor response to psychosocial interventions. There is a critical need to develop a mechanistic understanding of the link between social disconnection and suicidality, identify biological targets, and address targets with scalable interventions. The investigators developed a novel psychotherapy, Engage \& Connect, aimed to improve functions of the Positive Valence System (PVS) that are impaired in suicidality through increased engagement in rewarding social activities. This study will use state-of-the-art precision imaging methods and clinical measures to evaluate brain- and behavioral changes in the PVS during psychotherapy.

Participants will:

* Be randomly assigned to 9-weekly sessions of either Engage \& Connect therapy or Symptom Review and Psychoeducation
* Complete 4 research assessments
* Complete 3 MRI scans

Eligibility Criteria:
Inclusion Criteria:

* Ages aged 50-80 \[stratified so that 50% are older than 65\]
* Endorsement of Suicidal Ideation \[Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders-5 (SCID-5) Suicide Item (Item 9) with a score of 2
* Major Depressive Disorder as determined by the SCID-5
* Depression Rating Scale \[Montgomery-Åsberg Depression Rating Scale (MADRS)\] score of 16 or greater.
* Mini Mental Status Exam (MMSE) equal or greater than a score of 23
* Off antidepressants or on a stable dose of an antidepressant for 8 weeks and do not intend to change the dose in the next 10 weeks, without individual psychotherapy services during the study period.
* Capacity to provide consent for research assessment and treatment.

Exclusion Criteria:

* Intent or plan to attempt suicide in the near future.
* History or presence of psychiatric diagnoses other than major depressive disorder without psychotic features, generalized anxiety disorder, or specific phobia.
* Use of psychotropic drugs or cholinesterase inhibitors other than use of 0.5 mg or less of lorazepam daily up to seven times per week.
* Neurological disorders (dementias, amnestic and multidomain Mild Cognitive Impairment, Parkinson's disease, epilepsy, etc.).
* Acute or severe medical illness in the past 3 months (metastatic cancer, multiple sclerosis, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction, cardiac, renal, or respiratory failure; severe chronic obstructive pulmonary disease, etc.) that may be the primary cause depressive symptoms, influence brain systems of interest, or impact ability to participate in the study.
* Contraindications to MRI scanning including cardiac pacemaker, heart valve replacement, vascular stent, insulin pump, cochlear implant, any other metallic biomedical implant contraindicating to MRI, and claustrophobia.