cyrilzakka/clinical-trials huggingface dataset:
Battlefield Acupuncture for Low Back Pain

The purpose of this study is to determine the effect of Battlefield Acupuncture (BFA) on outcomes for pain, sleep, and physical activity level in an active duty military sample with subacute or chronic lower back pain (LBP). BFA is a form of auricular acupuncture (AA) that has been implemented in many Department of Defense (DoD)/Veterans Affairs (VA) medical settings to alleviate acute or chronic pain. BFA uses five predetermined locations in a defined sequence to place semi-permanent needles in the ear. Subacute lower back pain is pain that has persistently lasted from four to twelve weeks. Chronic lower back pain is pain that lasts more than 12 weeks.

Hypothesis 1: Participants with subacute or chronic LBP will have reduced pain using BFA as compared to placebo.

Hypothesis 2: Participants with subacute or chronic LBP will have improved physical activity using BFA as compared to placebo.

Hypothesis 3: Participants with subacute or chronic LBP will have improved sleep quality as compared to placebo.

The secondary study aims are:

1. To explore the effects of BFA two weeks following the treatment for LBP.

   1. Do positive outcomes appreciated with BFA persist over two weeks?
   2. What is the pain medication usage during and after intervention treatments?
2. To explore the effectiveness of BFA on trunk flexion mobility and balance.

   1. Does pain reduction improve trunk flexion and balance?
   2. Does improved truck flexion mobility and balance contribute to increased physical activity?


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of LBP (pain for \> 4 weeks, with or without radiating nerve pain
* Age 18 to 50 years
* Active duty military, Public Health Service, or Coast Guard (guard and reserve on active orders)
* Pain score 3/10 or higher as patient reported on the DVPRS
* mODI score ≥ 20%
* No anticipated prolonged temporary duty, deployment, or vacation within the next month.

Exclusion Criteria:

* Any severe comorbidity
* LBP neurologic "red flags" indicating serious spinal pathology (i.e. bowel or bladder dysfunction)
* Auricular acupuncture in the past 6 months
* Use of steroids in the month prior to the study
* Hemorrhagic disorders
* Malignancy
* Unexplained weight loss
* Severe scoliosis or congenital spine disorder
* Back pain because of a visceral problem (e.g. endometriosis)
* Under surgeon's care for back surgery within the last 12 months
* Balance disorder
* Pregnancy or suspected pregnancy (last menstrual period will be reported by the patient)
* Aversion to needles
* Previous keloid scar formation
* Active infection on the ear
* Bleeding disorder
* Metal allergy
* Mental health diagnosis requiring medication (depression, PTSD, etc)
* Untreated sleep apnea or other sleep disorders
Patient Controlled Analgesia Pump Cues on Patient Satisfaction

To examine whether providing patients with a cue to the availability of pain medication affects patient satisfaction, patient anxiety, PCA efficacy, and safety.

Post-operative pain is primarily managed via Patient-Controlled Analgesia (PCA). The newest PCA pumps can be programmed so that the button is backlit with a green light at the end of the lockout period, and the green light flashes when the medication is being dispensed. No studies have examined whether this type of visual cue would influence satisfaction or other patient outcomes (such as opioid consumption, PCA safety and patient anxiety) in children and adolescents, and no studies have examined whether pediatric patients' perspectives would be similar to those of adults.

Eligibility Criteria:
Inclusion Criteria:

* 7-18 years
* Opioid naïve
* Scheduled for a surgery for which a PCA is routinely used for post-operative pain management
* At least 1 parent speaks English

Exclusion Criteria:

* Prior experience with PCA
* Cognitive delay precluding independent use of the PCA button
* Current use of anxiolytics or antidepressants
* Patients receiving epidural analgesia
Dara-BCD for Rare MGRS

This is an open-label, multicenter, phase 2 study in subjects with newly diagnosed proliferative glomerulonephritis with monoclonal immunoglobulin deposits (PGNMIDs), OR light chain proximal tubulopathy (LCPT), OR thrombotic Microangiopathy (TMA), OR cryoglobulinemic glomerulonephritis, (CGGN), treated with daratumumab, bortezomib, cyclophosphamide, and dexamethasone.

The current study aims to investigate daratumumab, bortezomib, cyclophosphamide, and dexamethasone regimen in patients with newly diagnosed PGNMIDs, LCPT, TMA, CGGN. Approximately 10 subjects will receive primary therapy with daratumumab-CyBorD. The primary endpoint is overall complete hematologic response (CHR) rate at 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of PGNMIDs, OR LCPT, OR TMA, OR CGGN.
2. Evidence of clonal plasma cell in bone marrow.
3. ECOG 0,1,2
4. Neu≥ 1.0\*10\^9/L, HGB ≥70g/L, PLT ≥ 50\*10\^9/L.
5. Total bilirubin (TBil) ≤3×upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN;
6. Informed consent explained to, understood by and signed by the patient.

Exclusion Criteria:

1. Prior therapy for MGRS, with the exception of equal or less than 160 mg dexamethasone (or equivalent corticosteroid)
2. Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.
3. Presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis;
4. Severe or persistent infection that cannot be effectively controlled;
5. Presence of severe autoimmune diseases or immunodeficiency disease;
6. Patients with active hepatitis B or hepatitis C (\[HBVDNA+\] or \[HCVRNA+\]); Patients with HIV infection or syphilis infection;
7. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.
Anxiety Reduction in TAVI Using Virtual Reality Trial

The ART-VR Trial is an international multi-center, open label, randomized controlled trial evaluating the effect of an immersive VR environment on procedural anxiety in patients undergoing transfemoral aortic valve replacement (TAVR) under local anaesthesia.

Virtual reality (VR) allows patients to be fully immerged in an engaging, interactive 3D environment. Its applications are broad and include treatment of phobias, stress-disorders, pain reduction. Recently, VR has been adopted in various medical procedures to reduce pre- and per-procedural anxiety. In TAVR, per-procedural VR immersion could potentially reduce patient anxiety leading to increased overall patient satisfaction. However, contemporary large scale, randomized evidence on VR application in TAVR is lacking.

The objective of this trial is to evaluate the effect of an immersive VR environment on procedural anxiety in patients undergoing TAVR under local anaesthesia in a randomized controlled setting. A total of 150 patients with severe aortic stenosis (AS) who undergo transfemoral TAVR under local aneasthesia will be included. The main study endpoint is procedural anxiety assessed on a visual analogue scale (VAS) directly post-procedure.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Symptomatic severe aortic stenosis
* Indication for transfemoral TAVI under local anaesthesia per local heart team consensus
* Patient is able to understand and sign written informed consent
* Patient speaks Dutch, German or English

Exclusion Criteria:

* Need for emergent TAVI
* Need for planned concomitant cardiac intervention during index procedure
* History of TAVI under local anesthesia/conscious sedation
* Chronic use of benzodiapines, opioids, pregabalin or antidepressants
* History of opioid use (within 8-30 days prior to randomization)
* Claustrophobia
* Any psychiatric illness diagnosed by a psychiatrist or psychologist
* Blindness or severe visual impairment despite visual aid (glasses, contact lenses)
* Epilepsy
* Extensive cognitive impairment (MMSE \<21 or as diagnosed by geriatrician)
Improving Knowledge of Medication in Ulcerative Colitis With an Iphone Application

The purpose of this study is to assess an iPhone application to increase adherence to maintenance medications in subjects with ulcerative colitis.

Inflammatory bowel disease is a chronic condition that requires maintenance medication to maintain clinical remission. During clinical remission patient can be free of symptoms for long periods of time. Inflammatory bowel disease patients have been shown to have adherence rates around 40-60%. Non-adherence in patients in clinical remission is high with rates around 60%. Non adherence in patients in clinical remission can have significant impact because it can lead to higher rates of clinical flares and increased health care cost.

This will be a single-blinded randomized controlled trial to evaluate if patients randomized to an iPphone application vs. control can increase the adherence of their maintenance medication. The trial will last three months and we hope to enroll 99 patients.

The primary outcome will be adherence measured by the medication possession ratio. The secondary objective will be to evaluate if a validated adherence questionnaire can predict adherence in patients with inflammatory bowel disease.

Having an intervention that can increase adherence can provide better care for patients. Also having a validated survey tool can accurately identify non-adherence in inflammatory bowel disease patient would be a valuable tool for patient care.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 -65 years of age.
* Diagnosed with ulcerative colitis established by history and biopsy confirmed by gastroenterology.
* On a stable dose of mesalamine for at least two months prior to entering the study
* Have an iPhone (personal iPhone)
* Patient may receive steroid or mesalamine enemas during the study only on an as needed basis

Exclusion Criteria:

• Are on more than one medication for their inflammatory bowel disease
The Effects of Continuous Passive Motion on Hypertonia of Soleus in Individuals With Cerebral Palsy

Cerebral palsy (CP) is a group of disorders of the development of movement and posture but often changing motor impairment syndromes. The spastic subtypes are the most common manifestations of cerebral palsy who perform movement difficultly due to hypertonia. Decease of spinal cord pathway, hyperactivity of alpha and gamma motoneuron and reduction of presynaptic inhibition may cause tendon reflex increase and hypertonia in individuals with CP. There are many ways to improve the hypertonia. In the past studies, the fast repeated range of motion could reduce muscle's activation effectively. The polyarticular movement training might increase joint range of motion and reduce the muscle activation. But the polyarticular movement training is difficulty for some individuals with CP. The single joint movement training may achieve the same effect as the polyarticular movement training. The purpose of this study was to investigate the effects of continuation passive range of motion (CPM) training whether could get the improvement of soleus hypertonia in individuals with CP.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Spastic CP
* Modified Ashworth scale of Soleus \> 1
* Ankle range of motion \> 10 degrees

Exclusion Criteria:

* Fracture on lower Lower extremities
* BOTOX on ankle \< 5 mouths
Escitalopram Treatment of Major Depression in Patients With Temporal Lobe Epilepsy

This is a research study evaluating the use of escitalopram (Lexapro®) for the treatment of major depression in subjects with temporal lobe epilepsy. The purpose of the study is to measure the severity and change in depressive and anxiety symptoms after 10 weeks of study treatment with escitalopram or placebo as measured by certain rating scales and questionnaires. In addition, the study will measure the frequency of seizures using a patient diary during the study. Finally, the study will assess the change in the quality of life using rating scales.


Eligibility Criteria:
Inclusion Criteria:

1. Subject has a confirmed diagnosis of temporal lobe epilepsy
2. Subject meets DSM-IV criteria for Major Depression
3. MADRS greater than or equal to 15 at screening and baseline
4. Subject between ages of 18 and 65
5. Female subjects of childbearing potential must take adequate contraceptive precautions (methods with a published failure rate of less than 1% per year, or condom/diaphragm, or diaphragm/spermicide)
6. Subject must provide voluntary signed informed consent approved by the Institutional Review Board of LSU Health Sciences Center

Exclusion Criteria:

1. Any other primary axis I diagnosis other than Major Depression
2. The presence of psychogenic, non-epileptic seizures
3. A history of non-response to two or more antidepressants given for an adequate therapeutic trial
4. The presence of substance abuse or dependence in past six months
5. The presence of clinically significant malnutrition, cardiac, hepatic or renal disease that might endanger the safety of the subject
6. Pregnancy or nursing
7. Any subjects with suspected mental retardation, psychotic disorder or dementia
8. Subjects whose anticonvulsant medication regimen includes phenobarbital
9. Individuals who will require psychotropic medications such as benzodiazepines or medications likely to cause significant effects on mood or anxiety as outlined in section 5.4
10. Cognitive-behavioral therapy will not be allowed during the course of the study. Other psychotherapeutic modalities (supportive, psychoanalytic, etc.) will be allowed only if the individual has been in therapy for the previous 12 weeks and plans to remain in therapy throughout the duration of the study.
11. Individuals who in the opinion of the investigator would not be able to understand or comply with study requirements
12. Individuals with a known hypersensitivity to escitalopram or any of its ingredients
13. Individuals who in the opinion of the investigator present a significant risk of suicide, or have had a significant suicide attempt in the past two years.
COVID-19 Infections and Mortality in Long-term Care Facilities During the First Wave

The medical charts of all COVID-19 cases (n=1200) from 17 long-term care facilities in Montreal, Canada will be reviewed, to compare patients who survived to patients who did not survive. Through multilevel logistic regression, the risk of death will be estimated for institutional predictors of mortality, while controlling for individual risk factors.

Individual covariates include clinical features (age, sex, Charlston comorbidity index, SMAF autonomy score, severity criteria) and medical treatments (IV fluids, anticoagulation, oxygen, regular opiates, corticosteroids). Aggregate covariates include epidemiological data (attack rates, timing of outbreak) and institutional characteristics (number of beds, air exchange per hour, presence of a dedicated COVID-19 unit at the time of outbreak, staff compliance to infection control measures, staff infection rates, understaffing, proportion of semi-private rooms, proportion of wandering wards and other special units).

A lot has been written about individual risk factors for COVID-19 death, mostly in the hospitalized population. However, even though most deaths around the world have occurred among the frail and elderly, little is known about the risk factors specific to the long-term care population.

In this retrospective cohort study, the investigators will review the medical charts of all COVID-19 cases (n=1200) from 17 long-term care facilities in Montreal, Canada, to compare patients who survived to patients who did not survive. Through multilevel logistic regression, the risk of death will be estimated for institutional predictors of mortality, while controlling for individual risk factors. The objective is to influence local and national policies in long-term care facilities, in the hopes of avoiding the tragic spring 2020 outcomes during subsequent waves of COVID-19 or future pandemics.

Covariates in the models will be drawn from a review of the medical literature and known risk factors for COVID-19 death. Individual-level covariates include clinical features (age, sex, Charlston comorbidity index, SMAF autonomy score, severity criteria) as well as medical treatments (IV fluids, anticoagulation, oxygen, regular opiates, corticosteroids). Aggregate-level covariates include epidemiological data (attack rates, timing of outbreak) and institutional characteristics (number of beds, air exchange per hour, presence of a dedicated COVID-19 unit at the time of outbreak, staff compliance to infection control measures, staff infection rates, understaffing, proportion of semi-private rooms, proportion of wandering wards and other special units).

Eligibility Criteria:
Inclusion Criteria:

* Resident of a long-term care facility within the CIUSSS Centre-Sud-de-l'Île-de-Montréal
* Nosocomial COVID-19 infection diagnosis between March 23rd and July 11th 2020

Exclusion Criteria:

* Admission to the long-term care facility after July 11th 2020
* COVID-19 infection which was not acquired within the long-term care facility
Escalating Doses of PM01183 in Combination With Gemcitabine in Patients With Specific Unresectable Solid Tumors

Phase I multicenter, open-label, clinical and pharmacokinetic study of PM01183 in combination with gemcitabine in non-heavily pretreated patients with selected advanced solid tumors to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183 in combination with gemcitabine, to characterize the safety profile and feasibility of this combination in patients with selected advanced solid tumors, to characterize the pharmacokinetics (PK), to obtain preliminary information on the clinical antitumor activity in non-heavily pretreated selected solid tumor patients and to evaluate the pharmacogenomics (PGx) in tumor samples of patients exposed, in order to assess potential markers of response and/or resistance.


Eligibility Criteria:
Inclusion Criteria:

* Voluntarily written informed consent
* Age: between 18 and 75 years (both inclusive)
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1
* Life expectancy ≥ 3 months
* Patients with a histologically/cytologically confirmed diagnosis of advanced disease of any of the following tumors:

  1. Breast cancer
  2. Epithelial ovarian cancer (including primary peritoneal disease and/or fallopian tube carcinomas and/or endometrial adenocarcinomas)
  3. Stromal uterine sarcomas
  4. Non-small cell lung cancer (NSCLC)
  5. Platinum-refractory or relapsed germ cell tumors
  6. Adenocarcinoma of the exocrine pancreas
  7. Biliary tract adenocarcinoma
  8. Adenocarcinoma or carcinoma of unknown primary site
  9. Advanced or unresectable mesothelioma
* At least three weeks since the last anticancer therapy,including radiation therapy (RT)
* Adequate bone marrow, renal, hepatic, and metabolic function
* Left ventricular ejection fraction (LVEF) by echocardiography (ECHO) or multiple-gated acquisition (MUGA) within normal range (according to institutional standards).
* Women of childbearing potential must have a negative serum pregnancy test before study entry. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for six weeks after discontinuation of treatment.

Exclusion Criteria:

* Concomitant diseases/conditions:

  * History or presence of unstable angina, myocardial infarction, congestive heart failure, or clinically significant valvular heart disease within last year.
  * Symptomatic or any uncontrolled arrhythmia
  * Ongoing chronic alcohol consumption, or cirrhosis
  * Active uncontrolled infection.
  * Known human immunodeficiency virus (HIV) infection.
  * Any other major illness that, in the Investigator's judgment
* Brain metastases or leptomeningeal disease involvement
* Men or women of childbearing potential who are not using an effective method of contraception
* Patients who have had radiation therapy in more than 35% of the bone marrow
* History of previous bone marrow and/or stem cell transplantation
* Prior treatment with gemcitabine-containing therapy for advanced disease
Observational Study on the Use of IV (Intravenous) Iron Therapy Among Subjects With Iron Deficiency Anemia

The primary objective of this study is to compare the total costs to sites and payers of administering IV iron over the 30-day observation period for subjects with IDA who receive Ferric Carboxymaltose (FCM) relative to those who receive iron sucrose, iron dextran, and ferumoxytol.

The primary objective of this study is to compare the total costs to sites and payers of administering IV iron over the 30-day observation period for subjects with IDA who receive Ferric Carboxymaltose (FCM) relative to those who receive iron sucrose, iron dextran, and ferumoxytol.

Eligibility Criteria:
Inclusion Criteria:

* Must present for the first dose of a current cycle of IV treatment for IDA
* Must be over 18 years of age
* Must be willing and able to provide informed consent, including permission to obtain information from their medical records.
* Must be able to read and understand English.

Exclusion Criteria:

* Subjects not diagnosed with IDA.
* Subjects requiring more than one treatment cycle within 30 days.
* Subjects receiving maintenance IV iron therapy.
* Subjects treated with IV iron within the 30-day period prior to study enrollment.
* Subjects who received investigational medication in the six months prior to the study.