cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of a Condensed Functional Restoration Program for Patients With Chronic Low Back Pain: a Study of 193 Patients

The aim was to assess the effectiveness of a condensed functional restoration program (CFRP) for patients with chronic low back pain and professional activity.

Methods: Longitudinal 1 to 3 months study of patients with non-specific chronic low back pain in one tertiary care hospital, participating in a CFRP (complex interprofessional intervention over 4 days). The primary outcome was the Oswestry Disability Index (ODI) (0-100 scale). Secondary outcomes included pain, quality of life (EQ5D), patient acceptable symptom state, presenteeism, absenteeism and psychological distress (Hospital Anxiety and Depression scale). Outcomes were compared using paired sample Student's t-test or Chi2 between baseline and last follow-up. Logistic regression was used to identify factors associated with better response (improvement of ODI higher than 12.8) and included baseline demographic, psychological and physical assessment variables.


Eligibility Criteria:
Inclusion Criteria:

* non-specific cLBP (\>3 months) with or without radicular pain, not currently in prolonged sick leave, no current indication for surgery, fluent in French, difficulties to maintain daily physical activity due to LBP with Oswestry Disability Index and lumbar and radicular pain at baseline and at end of intervention or 3-month follow-up available.

Exclusion Criteria:

* specific LBP and organic contraindication to physical exercise.
Treatment for Depression in the Primary Care Setting

This study will compare a brief form of counseling to usual care for the treatment of minor depression in the primary care setting.

Minor depression is one of the most common types of depressive disorders seen in primary care. The effectiveness and tolerability of antidepressants in patients with minor depression is unclear, and the development of alternative treatments is necessary.

In the first phase of this study, participants are observed for 4 weeks to identify those most in need of depression-specific treatment. Participants are then exposed to the Problem-Solving Treatment for Primary Care (PST-PC), a six-session behavioral treatment for depression. After 4 weeks, patients who do not respond adequately to the treatment are randomly assigned to either continued PST-PC or to usual care for 9 weeks. Participants are followed for 6 months after the study.

Eligibility Criteria:
Inclusion Criteria:

* Primary care patient at Dartmouth-Hitchcock Medical Center (DHMC)
* Hamilton Depression Score \>= 10 and minor depression at time of entry and after 4 weeks of observation

Exclusion Criteria:

* Psychosis, Obsessive Compulsive Disorder (OCD), or Post Traumatic Stress Disorder (PTSD)
* Active substance abuse
* Receiving treatment for depression
Use of Morphine Gel Topically in Patients With Stage 2-3 Wounds

Morphine gel applied topically to wounds will reduce wound pain and decrease patients use of oral and intravenous pain medications, therefore reducing side effects.

Patients will be randomized to receive either placebo (versa base gel) or morphine gel to wound. Patients receiving morphine gel will have a decrease in pain score and use less oral/intravenous pain medications.

Eligibility Criteria:
Inclusion Criteria:

* Signed and dated consent form \& HIPAA
* \> 18 yo
* Single stage 2-3 wound
* No allergy to morphine
* Alert and oriented (thinking ability clear and intact, physician approval)
* English language proficiency

Exclusion Criteria:

* Allergy to morphine, codeine, or versa base, pts taking medications for acute condition, other than for the wound pain
* Patients with neuropathies
* Patients with respiratory conditions
Body Surface Area-based vs Concentration-based Dosing of Cisplatin for Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Women With Advanced Ovarian Cancer

Cytoreductive surgery (CRS) with the addition of hyperthermic intraperitoneal chemotherapy (HIPEC) is used in current clinical practice in selected patients with advanced ovarian cancer. Clinical evidence for the benefit of HIPEC in ovarian cancer comes from the pivotal phase 3 OVHIPEC trial. Worldwide, two established strategies exist for dosing of HIPEC protocols, which follow either a body surface area (BSA)-based or a concentration-based approach. Since both strategies result in different exposure to intra-peritoneal chemotherapy, we aim to compare the pharmacokinetics and safety of both strategies.


Eligibility Criteria:
Inclusion Criteria:

1. signed and written informed consent
2. age ≥ 18 years
3. patients eligible for interval cytoreductive surgery

   1. histological proven FIGO stage III primary high grade serous ovarian, fallopian tube, or extra-ovarian cancer
   2. when only cytology is performed to confirm the diagnosis ovarian carcinoma, immunohistochemistry should be performed including keratin 7, keratin 20, p53, PAX8
   3. neo-adjuvant chemotherapy consists of (at least) 3 courses of carboplatin/paclitaxel
   4. following 2 cycles of chemotherapy no progression should occur
4. treated with optimal or complete interval cytoreductive surgery
5. fit for major surgery, WHO performance status 0-2
6. adequate bone marrow function (hemoglobin level \>5.5 mmol/L; leukocytes \>3 x 109/L; platelets \>100 x 109 /L)
7. adequate hepatic function (ALT, AST and bilirubin \<2.5 times upper limit of normal)
8. adequate renal function (creatinine clearance ≥ 60 ml/min using Cockcroft-Gault formula or 24-hour measurement or ml/min/1,73 m2 using MDRD or CKD-EPI)
9. able to understand the patient information

Exclusion Criteria:

1. history of previous malignancy treated with chemotherapy
2. opting for fertility-sparing surgery
Chemo-embolization for Head and Neck Cancer

The study will evaluate whether adjuvant chemo-embolization increases progression free and/or overall survival relative to standard of care radiation and chemo- and/or immunotherapy in cisplatin-ineligible head and neck cancer patients with an acceptable morbidity rate.

This is a single site, single arm Phase II trial pilot study to explore if chemo-embolization increases progression free and/or overall survival in a subpopulation of cisplatin-ineligible head and neck cancer patients with an acceptable morbidity rate in the U.S. Chemo-embolization will serve as adjuvant therapy performed in addition to standard of care radiation and chemo- and/or immunotherapy. Within UAB, the Investigators plan to recruit 48 patients to implement the intervention, within a two-year period. Progression free survival will be assessed at 3, 6 and 24 months (if available) after intervention, which is determined based upon the results of follow-up Head and Neck imaging (CT or MRI) interpreted by a Radiologist not involved in the study, per standard of care. Overall survival will be reported by the patients' Oncology team on a monthly basis. The trial endpoints will form the basis of how PFS and OS compare to historical outcomes in a similar cohort of patients.

Eligibility Criteria:
Inclusion Criteria:

* 1. Provision of signed and dated informed consent form
* 2.Stated willingness to comply with all study procedures and availability for the duration of the study
* 3.Male or female, aged 18 or older
* 4.Diagnosed with squamous cell carcinoma of the Head and Neck
* 5.Ability to undergo chemo-embolization
* 6.For females of reproductive potential: Negative pregnancy test at time of chemo-embolization
* 7.Platinum-ineligible as determined by presence of CTS grade I nephropathy, neuropathy or otopathy, and/or ECOG 2+ performance status.
* 8.Plan to undergo standard of care radiation and chemo- and/or immunotherapy.

Exclusion Criteria:

* 1. Medically unfit to undergo chemo-embolization
* 2. Treatment with a competing investigational drug or intervention trial that does not allow adjuvant chemo-embolization.
Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells in Patients With Alzheimer's Disease

The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the disease pathology of patients with Alzheimer's Disease and clinical outcomes?

Autologous Adipose-derived Stromal Vascular Fraction (AD-SVF) will be infused intra-venous and Intra nasal. The therapy is composed of cells derived from a patients' own adipose tissue that are isolated within approximately 1 hour and immediately delivered back to the patient.

Eligibility Criteria:
Inclusion Criteria:

* Males or females, age 55 or older
* Diagnosis of probable Alzheimer's disease, consistent with criteria from both: 1) National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and 2) Diagnostic and Statistical Manual of Mental Disorders (DSM IV)
* Up to date on all age and gender appropriate cancer screening per American Cancer Society (Refer to section 9.3 for more details).

Exclusion Criteria:

* Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
* Life expectancy \< 6 months due to concomitant illnesses.
* Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
* Active infectious disease. For patients who have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM \> IgG) and/or syphilis ,then an expert will be consulted as to patient eligibility based on the patient's infectious status
* Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
* Patients on chronic immunosuppressive transplant therapy
* Systolic blood pressure (supine) ≤90 mmHg;
* Resting heart rate \> 100 bpm;
* Active clinical infection.
* Cerebrovascular accident within 6 months prior to study entry
* Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
* History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
* Patient or legal guardian if applicable us unwilling and/or not able to give written informed consent.
* Dementia due to any condition other than AD, including vascular dementia
Implicit Versus Explicit Motor Training for Upper Extremity Rehabilitation in Chronic Stroke Patients

Training methods that improve proprioception of the shoulder joint involve specific tasks targeting joint position sense, kinesthesia, or sense of force. These exercises can involve explicit or implicit motor learning. Explicit learning involves verbal knowledge of movement performance, while implicit learning involves minimal verbal knowledge and learning in a less conscious manner. The purpose of the study is to identify the efficacy and difference between implicit and explicit motor training in improving upper extremity functions in chronic stroke patients. The study will use laser pointer pattern tracking exercises and precise repositioning tasks for explicit motor training and a cognitive-motor dual-task training for implicit motor training. The laser-pointer assisted angle reproduction test, Wolf Motor Function Test and Arm Motor Ability Test will be used for evaluation.


Eligibility Criteria:
Inclusion Criteria:

1. Age is ranging between 50 to 65 years
2. Diagnosis of a single stroke 6 months to 2 years prior to study entry confirmed by neuroimaging reports (to minimize the chance that improvements occur because of spontaneous recovery).
3. Sufficient cognitive and language abilities to understand and follow multiple-step instructions (a score of 24 or more on the mini mental state examination).
4. Adequate vision to track the laser beam.
5. Muscle strength of ≥ 3/5 for all upper extremity joints on manual muscle testing.
6. Subjects are able at least to partially move outside of synergies at the affected elbow (Brunnstrom recovery stage in the upper limb following stroke is 4 or greater)
7. Spasticity at the paretic elbow, wrist, or fingers, defined as a score less than 2 on the modified Ashworth scale.

Exclusion Criteria:

1. Uncontrolled seizure disorders.
2. Additional neurological impairments, for example, Parkinson disease that (severely) influence their upper limb functions.
3. Excessive spasticity at the paretic upper limb muscles defined as a score equal or more than 2 on the modified Ashworth scale.
4. Excessive pain in the affected UE, as measured by a score of 5 or higher on a 10-point visual analog scale.
5. Patients with musculoskeletal disorders of upper limb joints, such as severe arthritis, fractures, or fixed deformities.
6. Patients with cognitive, visual, or auditory impairments.
Tocotrienols for School-going Children With ADHD

The purpose of this study is to determine if tocotrienol supplementation given to school going children with ADHD will result in reduction of their ADHD symptoms.

The main objective of the study is to:

a. Determine if supplementation of tocotrienol compared to placebo has an effect on the symptoms of school going children with ADHD.

The secondary objective is to:

1. Determine if supplementation of tocotrienol compared to placebo has an effect on the dose of current medication used in school going children with ADHD.
2. Determine the safety of tocotrienol in the study population.
3. Determine if tocotrienol levels in children with ADHD correlate with their symptom scores.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with ADHD in accordance with the Diagnostic and Statistical Manual (DSM) IV criteria.
* Be able to swallow soft gel capsules.
* If already on medication for ADHD, the dose of the medication must be stable for the last 3months
* Be able to attend all follow up visits.
* Be agreeable to have their teacher score the National Initiative for Children's Healthcare Quality (NICHQ) Vanderbilt Assessment Scale - Teacher Informant
* Be willing to have their blood taken 3 times during the study.

Exclusion Criteria:

* ADHD caused by syndromes, inborn errors of metabolism, or structural brain lesions.
* Co-existing chronic liver disease
* Current use of anticoagulant or antiplatelet drugs.
Understanding Value in Metastatic Breast Cancer

The overall objective of this project is to gain knowledge about out-of-pocket (OOP) expenses and lost opportunity costs among metastatic breast cancer (MBC) patients. To achieve this objective, MBC patients will be asked to participate in a short, 37-question survey asking questions about the financial burden, OOP expenses, and opportunity costs related to their cancer care

The treating physician, PI or study coordinator will inform eligible MBC patients about the study via a letter (Appendix B) during or prior to their regular clinic visits in a waiting area. Prior to the survey administration, study coordinator will obtain all necessary signatures on the ICF from interested study participants in the private clinic room or infusion area. The survey (Appendix A) will consist of 37 survey questions, which should take patients less than 30 minutes to complete during their regularly scheduled clinic visit. Study participants will have the option of taking incomplete surveys home, completing, and mailing it back to us using stamped, self-addressed envelopes provided during their clinic visit. All consented participants will also be given the option to complete the survey over the phone with a study coordinator. Participants will be requested to provide their preferable times and days for a phone call with a coordinator. The study coordinator will call the patient and administer the same survey that would be given during a clinic visit. If participants prefer completing the survey in the clinic a research coordinator will remain in the room and will verbally facilitate the completion of the survey. Participants will be compensated in the form of merchandise at the time they agree to participate (the photo of sample merchandise is attached). Surveys will be collected by the study coordinator and stored in secure, locked rooms at the UAB Comprehensive Cancer Center, where the study coordinators will double-key enter de-identified survey responses into an encrypted, password protected, electronic database.

Eligibility Criteria:
Inclusion Criteria:

* All female MBC patients 18 years of age and older who have received treatment within the past two years at UAB

Exclusion Criteria:

* Non-English speakers, patients residing in nursing homes or receiving hospice care
Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)

A double-blind, phase 3 study to determine the efficacy of SPL7013 Gel when administered on alternate days for 16 weeks, compared to placebo gel in preventing the recurrence of BV in women with a history of recurrent BV.

Eligible participants, with both a history of recurrent BV and a current episode of BV, will receive a seven-day course of oral metronidazole. Participants who are successfully treated for their BV, and continue to be eligible, will be randomly assigned to receive either 1% SPL7013 Gel or placebo gel on alternate days at bed-time for 16 consecutive weeks.

The primary endpoint will be determined at the conclusion of this 16 week treatment phase.

Participants who experience a BV recurrence will be considered to have completed the study. Such participants will receive BV treatment in line with local practice and will not attend any further study visits.

Participants who successfully reach Week 16 without a BV recurrence will enter a 12-week follow-up phase to Week 28.

Participants will attend a study visit at 4-weekly intervals throughout the duration of the study to Week 28 (or up to the point of BV recurrence) to assess recurrence of BV and adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Current active episode of BV (diagnosis defined as: at least 3 Amsel criteria; Nugent score of at least 4; presence of BV-related symptoms)
* History of recurrent BV (at least 3 episodes in previous year including current episode)
* Using an effective method of contraception

Exclusion Criteria:

* Test positive for a sexually transmitted infection
* Presence of genital Herpes Simplex Virus (HSV) lesions or Human Papilloma Virus (HPV) lesions requiring treatment
* Abnormal pelvic exam, including presence of other vaginal or urinary tract infections
* Pregnancy
Assessing the Clinical Utility of Adding Pentoxifylline to Neoadjuvant Chemotherapy Protocols in Breast Cancer Patients"

Breast cancer, a leading cause of cancer-related mortality in women worldwide, has spurred the investigation of novel therapeutic approaches. Pentoxifylline (PTX), a synthetic methylxanthine derivative, has shown promise in preclinical studies when combined with conventional anticancer drugs. This study aims to assess PTX's impact when added to neoadjuvant chemotherapy protocols in breast cancer patients, with the goal of improving treatment outcomes and reducing associated toxicities.


Eligibility Criteria:
Inclusion Criteria:

* Adult female patients \>18 years old with histologic confirmation of invasive breast cancer
* Planned to administer neoadjuvant chemotherapy protocol comprised of doxorubicin/ cyclophosphamide followed by paclitaxel (AC/T)
* Adequate hepatic, renal, and bone marrow functions

Exclusion Criteria:

* Patients on treatment regimen of phosphodiesterase inhibitors
* Patients who are taking antiplatelet or anticoagulant treatment
* Patients who are allergic to phosphodiesterase inhibitors
* History of recent hemorrhagic events
* Active peptic ulcer
Ultra Low Iodine Loaded Spectral CT Angiography (CTA)

The objectives of this study are:

Evaluation of ultra-low iodine load CTA protocols of the aorta and lower extremities.

To investigate whether dual-layer in combination with with virtual monoenergetic imaging (VMI) allows for reduction of contrast medium (CM) in CTA of the aorta and lower limbs i with sustained objective and subjective image quality parameters.

CT angiography (CTA) of the aorta and the lower limb is one of the most important tools for diagnostic, evaluation of the severity of the peripheral arterial disease, decision making, treatment planning and follow-up; but usually requires the use of iodine contrast medium.

Due to the high prevalence of renal impairment (eGFR \< 90 ml/min/1.73m) in the elderly hospitalized population (more than 90% among inpatients aged over 60 years) contrast-medium-induced nephropathy is a major concern in this population.

The recently introduced spectral CT technique utilizes x-rays covering a spectrum of energy-levels as opposed to conventional CT in which x-rays are set to one specific energy level.

This technology offers many possibilities, such as "boosting" the x-ray contrast effect of iodine. This improves the vascular enhancement of the contrast medium using low-energy, virtual monoenergetic imaging (VNI).

The objectives of this study are:

Evaluation of ultra-low iodine load CTA protocols of the aorta and lower extremities.

To investigate whether dual-layer in combination with with virtual monoenergetic imaging (VMI) allows for reduction of contrast medium (CM) in CTA of the aorta and lower limbs i with sustained objective and subjective image quality parameters.

Eligibility Criteria:
Inclusion Criteria:

* Inpatients and outpatients with kidney function (eGFR) allowing for safe administration of standard contrast dose (as calculated with the OmniVis calculator).
* Patients with clinical suspicion of disease of the aorta and/or arteries in the lower limb.
* Referral to CTA diagnosis, treatment planning or follow-up.

Exclusion Criteria:

* Iodine contrast medium allergy
* Age \< 18 years
* Lack of informed consent
* Critical ischemia of the lower extremities
Rumination-focused CBT Training for the Prevention of Depression and Anxiety

Depression and anxiety disorders are highly prevalent and associated with reduced quality of life for patients and enormous economic costs for society. Although effective treatments are available, a substantial number of patients fail to respond, and the time between disorder onset and treatment is typically long. The development of prevention programs therefore appears promising. The current project aims to prevent depression and anxiety by targeting excessive levels of worry and rumination, two important risk factors for emotional disorders. Participants will be selected on the basis of a high score on two validated questionnaires on worry and rumination. They will be randomly assigned to a rumination-focused cognitive-behavioral training delivered in a group format, a rumination-focused cognitive-behavioral training delivered via internet, or a no-training control condition. It is expected that both versions of the rumination-focused training will reduce symptoms of depression and anxiety, will reduce the incidence of major depressive episodes and generalized anxiety disorder, and will reduce symptom levels of other emotional disorders.

see above

Eligibility Criteria:
Inclusion Criteria:

* A score above the 75% and 66.7% percentile on two validated self-report measures of rumination and worry, the Ruminative Response Scale of the Response Style Questionnaire (RSQ; Nolen-Hoeksema \& Morrow, 1991), and the Penn State Worry Questionnaire (PSWQ; Meyer et al. 1990).

Exclusion Criteria:

* A score indicating fulfillment of DSM-IV criteria for depression or generalized anxiety disorder according to the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, \& Williams, 2001) or the Generalized Anxiety Disorder Questionnaire-IV (GADQ-IV; Newman et al., 2002)