cyrilzakka/clinical-trials huggingface dataset:
Positive Affect as a Source of Resilience for Adults in Chronic Pain

Fibromyalgia syndrome (FMS) is a chronic musculoskeletal condition characterized by widespread pain and tenderness, and often accompanied by impaired physical functioning, depressed mood, as well as deficits in positive affect (PA).Standard behavioral therapies typically focus on minimizing negative thoughts and emotions associated with pain and yield only modest treatment effects. Efforts are therefore needed to develop more effective psychological treatments for chronic pain by identifying new targets for intervention.

The objectives of this Stage I randomized pilot trial are to evaluate the feasibility, acceptability, and the impact of a previously developed online positive affect (PA) skills intervention -LARKSPUR (Lessons in Affect Regulation to Keep Stress and Pain UndeR control)-in a sample of Hispanic, non-Hispanic other, and non-Hispanic African American patients with fibromyalgia syndrome (FMS).

Specific Aims:

Aim 1: To maximize relevance and acceptability of content and delivery of LARKSPUR intervention among patients with FMS, a chronic pain population with known deficits in PA. This aim will establish the feasibility (recruitment and retention) and acceptability (helpfulness, satisfaction, and impact) of the multicomponent LARKSPUR intervention in Hispanic, non-Hispanic African American and non-Hispanic other patients with FMS.

Aim 2: To conduct a randomized pilot trial to evaluate the impact of the LARKSPUR intervention in FMS pain (primary outcome), as well PA, depressive symptoms, physical functioning, and stress appraisals (secondary outcomes) and Aim 2a: explore racial/ethnic disparities.

For Aim 1, the study team will pilot LARKSPUR to examine feasibility and acceptability of the intervention framework by conducting frequency and descriptive statistics for enrollment rates, number of sessions completed, number of weeks required to complete the intervention, and Likert-scale items assessing satisfaction with the intervention and perceived helpfulness. For Aims 2, FMS patients (target N=90) will be randomized to receive the LARKSPUR content online or to complete daily emotion reports online (control). The researchers hypothesize that intervention participants will report more frequent PA, decreased depressive symptoms, enhanced physical functioning, improved stress appraisals, and reduced FMS pain (intensity and interference) immediately following the intervention (approximately 6-8 wks) and at 1-month post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* Access to daily internet
* ≥ 50 years of age
* Able to read and understand English
* Physician diagnosis confirmation of FMS AND/OR Score ≥ 13 on the 6-item, self-report fibromyalgia screening tool
* Report having pain for at least the last three months

Exclusion Criteria:

* Cognitive impairment
* Current behavioral treatment for pain
* Enrolled in another pain study
Rituximab and Chemotherapy Followed by Ibritumomab Tiuxetan as Treatment for Low Grade Follicular Non-Hodgkin's Lymphoma

In this trial, we will evaluate the feasibility, toxicity, and effectiveness ibritumomab tiuxetan, when incorporated into combination first-line treatment for follicular lymphoma. Addition of the ibritumomab tiuxetan to our previously evaluated, well tolerated combination of rituximab and short course chemotherapy will allow the use of additional active agent with a unique mechanism of cytotoxicity. In addition, "debulking" of lymphoma prior to 90Y Zevalin administration may minimize the myelotoxicity of this agent.

Upon determination of eligibility, patients will be receive:

* Rituxan + CHOP or CVP + Ibritumomab Tiuxetan

Patients who are considered medical candidates for doxorubicin should receive CHOP chemotherapy (Cyclophosphamide, doxorubicin, vincristine and prednisone). Patients who are not considered medical candidates for doxorubicin should receive CVP chemotherapy (Cyclophosphamide, Vincristine, and prednisone)

Eligibility Criteria:
Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Histologic documentation of follicular center, B-cell lymphoma
* Early stage lymphoma (stages I or II) relapsed after radiation therapy alone
* No previous chemotherapy or monoclonal antibody therapy
* Measurable or evaluable disease
* Able to perform activities of daily living with minimal assistance
* Age \> 18 years
* Adequate bone marrow ,liver and kidney function
* Must be accessible for treatment and follow-up.
* Bone marrow examination initial staging and accurate restaging
* All patients must give written informed consent prior to study entry.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Small lymphocytic (CLL type) lymphomas and CLL
* Impaired bone marrow reserve
* Female pregnant or lactating
* Serious active infection at the time of treatment
* Any other serious underlying condition
* Central nervous system involvement (brain or meningeal)
* HIV or AIDS-related lymphoma
* Received prior external beam radiation therapy to \> 25% of active bone marrow
* Pleural effusion
* Received prior murine antibodies or proteins
* History of other neoplasms within five years of diagnosis

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Pregabalin and Radicular Pain Study (PARPS)

This study is designed to investigate the effectiveness of pregabalin (Lyrica) on nerve pain caused by degenerative neck problems. Pregabalin is a new drug registered for use in nerve pain worldwide

The treatment of neuropathic pain is clinically challenging, and pain from cervical spondylosis (CS) is a common variant. This may result from degenerative spinal canal/cord stenosis (cervical spondylotic myelopathy (CSM)) or lateral recesses compromise, leading to nerve root compression (cervical spondylotic radiculopathy (CSR)).

Pregabalin is a newly registered drug for the treatment of neuropathic pain. Its efficacy has been proven in randomised, placebo-controlled trials for post-herpetic neuralgia and diabetic neuropathy. However, its efficacy in CS with underlying CSR or CSM has not been established. Additionally, there are no data to date on its use in Asian patients.

In this study, we prospectively evaluate its efficacy for treating neuropathic pain in degenerative CSR/ CSM 60 patients in an open-labelled, add on fashion. Self-evaluation and investigator rated scoring will be implemented.

The results will be of value in the non-operative management of CS.

Eligibility Criteria:
Inclusion Criteria:

* Clinical \& MRI, or electrophysiological evidence of pain due to radiculopathy
* Patients with CS and CSR or CSM with neuropathic pain due to the above in the neck and upper limbs or lower limbs (including dysesthesia, paresthesia, hyperalgesia).

Exclusion Criteria:

* Diabetic neuropathy or other underlying neuropathic conditions
* Contraindications and allergy to pregabalin
* Previously treated with gabapentin in the last 8 weeks
* Pregnant or breast feeding
* History of renal impairment
* History of other causes of neuropathic pain
The Effect of Subtalar Joint Antipronation Taping on the Dynamic Knee Valgus in Female Volleyball Players with Low Medial Arch

This study aims to investigate the biomechanical mechanisms of dynamic knee valgus and the impact of subtalar pronation, particularly due to decreased medial longitudinal arch, on knee injury risk, highlighting the importance of prevention and intervention strategies for athlete health.

Dynamic knee valgus is an abnormal movement pattern of the lower extremity, formed by the combination of femoral adduction and internal rotation, tibial abduction and internal rotation, and subtalar pronation, and it is a significant risk factor for knee injuries. The foot and ankle represent the first link in the lower extremity kinetic chain, and a mechanical relationship between subtalar joint motion and tibial rotation triggers internal rotation of the tibia during weight-bearing. This is particularly more pronounced in female athletes, as increased foot pronation and medial longitudinal arch (MLA) drop contribute to dynamic knee valgus. Supporting the MLA has become increasingly important in injury prevention, as there is evidence in the literature showing that interventions to reduce foot pronation decrease dynamic knee valgus and help prevent patellofemoral pain and anterior cruciate ligament injuries.

The aim of this study is to investigate the effects of antipronation taping on dynamic knee valgus and knee flexion angle during functional jump tests in female volleyball players with MLA drop. Innovative taping materials, such as Dynamic Tape, when applied correctly, can support the MLA, reduce tibial rotation, and decrease abnormal movements. While there is existing evidence that MLA-supporting orthotics reduce such injury risks, no studies have specifically examined antipronation taping with Dynamic Tape applied to the subtalar joint. This study seeks to explore modifiable risk factors associated with common knee injuries in female athletes from a foot posture perspective and contribute to athlete health.

Eligibility Criteria:
Inclusion Criteria:

Actively playing volleyball for at least 5 years, A drop of 10 mm or more in the navicular drop test, A score of ≥ +4 according to the A foot posture index.

Exclusion Criteria:

A history of lower extremity injury within the last 3 months, A history of ankle and/or knee surgery, Having non-structural instability, A history of congenital or traumatic deformity in the lower extremity.
Effects of Lymph Drainage on Patients With Axillary Web Syndrome

Effects of a physical therapy program combined with manual lymphatic drainage on shoulder pain and function, quality of life, lymphedema incidence in breast cancer patients with axillary web syndrome following axillary dissection: A randomized controlled trial.

This study's objective is to assess the effectiveness of physical therapy (PT) combined with manual lymphatic drainage (MLD) on shoulder pain and function, lymphedema, visible cords, and quality of life (QOL), compared to physical therapy alone, in subjects with breast cancer and suffering of axillary web syndrome (AWS).

Eligibility Criteria:
Inclusion Criteria:

* had a breast cancer dissection with lymphadenectomy and/or sentinel lymph node biopsy and a subsequent appearance of AWS (diagnosed by physical examination and also by using the Screening Test AWS (ST-AWS)) \[35\].

  * suffering of pain that exceeds 6-8 points (measured by the numeric rating scale (NRS)) in the region of the cording on the upper/lower arm, elbow, and dorsum site, and
  * have visible or palpable cords in the arm or breast.

Exclusion Criteria:

* suffering of both acute thrombosis and lymphedema,

  * suffering of skin issues like infections or musculoskeletal conditions like adhesive capsulitis, rheumatoid arthritis, pectoral muscle tightness, and diseases of the rotator cuff, and/or
  * having cording that doesn't involve an arm and only affects the chest or side of the thorax.
Evaluation of Chlorhexidine Gluconate Concentration on Skin of Human Subjects Following Multiple Application Times

This study will evaluate the amount of chlorhexidine gluconate (CHG) present on treated skin of human volunteers following different application times with a test material bathing system. The amount of recovered CHG that resides on the skin following each of the evaluated application times will be evaluated via high performance liquid chromatography with ultraviolet detection (HPLC-UV) and correlated with the MIC values determined separately.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be at least 18 years of age and can be of either sex and of any race.
* Subjects must be able to read and understand English.
* Subjects must possess both forearms and have a minimum forearm length (wrist crease to elbow crease) of 8.25 inches \[21 cm\].
* Subjects must be in good general health (i.e., no current or recent severe illness) and have no medical diagnosis of mitral valve prolapse with heart murmur, congenital heart disease, an organ transplant, medicated or uncontrolled diabetes, hepatitis B or C, an immunocompromised condition such as AIDS (or HIV positive), lupus, fibromyalgia, ulcerative colitis, Crohn's disease, moderate to severe asthma (requiring daily use of medication), or medicated multiple sclerosis.

Exclusion Criteria:

* Participation in a clinical study within 7 days of participating in this study or current participation in another clinical study.
* Presence of tattoos, active skin rashes, dermatoses, or breaks in the skin of the forearms or hands. Subjects must also have no inflammatory skin conditions (such as atopic dermatitis / eczema, contact dermatitis, or psoriasis) anywhere on the body.
* Known allergies or sensitivities to latex (natural rubber), alcohols, sunscreens, deodorants, laundry detergents, inks, metals, topically-applied fragrances (e.g., colognes or perfumes), cleansers, soaps, lotions, or to common antibacterial agents particularly chlorhexidine gluconate (CHG).
* Have experienced hives (raised welts) as a reaction to anything that contacted the skin, with the exception of plants known to cause reactions for most humans (e.g., poison oak or poison ivy).
* Have a history of anaphylactic shock, anaphylactoid reaction, or anaphylactoid shock.
* Any prosthetic device or joint (e.g., pins, screws, plates, or rods) installed in the arms within the last 6 months.
* Any type of indwelling port or Peripherally-Inserted Central Catheter (PICC).
* Subject is pregnant, plans to become pregnant or impregnate a sexual partner within the pre-test and test periods of the study, or is nursing a child.
* Any medical condition or use of any medications that, in the opinion of the Principal Investigator or Consulting Physicians, should preclude participation.
Administration of Human Protein C Concentrates in Patients With Sepsis and Septic Shock.

The purpose of this study is to investigate the effects on systemic hemodynamics, microcirculation and organ function of human Protein C concentrate in patients with sepsis and septic shock.

Sixty septic patients with plasma protein C activity \< 60 % will be enrolled in the study. Patients will be randomly allocated to be treated with either a) a continuous infusion of human Protein C concentrate at 3 UI/Kg/hr for 72 hours to reach plasma protein C activity between 70 and 120 % b)to a continuous infusion of activated protein C at 24 micrograms/Kg/hr for 96 hours, c) a standard teatment(control; each n = 20). In all groups, norepinephrine will be titrated to achieve a mean arterial pressure (MAP) between 65 and 75 mmHg. Data from right heart catheterization, from microcirculation (SDF imaging) and from organ function as well as norepinephrine requirements will be obtained at baseline and after 24, 48, 72 hours.

Eligibility Criteria:
Inclusion Criteria:

* Severe sepsis or septic shock with plasma activity of protein C \< 60 %

Exclusion Criteria:

* Pregnancy
* Risk of Bleeding
* Hemorragia
* age \< 18
Comparison of Propofol Based Versus Volatile Based Anesthesia and Postoperative Sedation

All patients undergoing cardiac surgery require intraoperative anesthesia and short-term postoperative sedation with anesthetic agents after the procedure when patient is in the intensive care unit (ICU). The clinical data obtained so far are concentrating on intraoperative use volatile agents (preconditioning) resulting in better postoperative cardiac function and less release of biochemical markers of myocardial damage. There are no studies investigating whether postoperative use of volatile agents (post conditioning) in cardiac surgical population is improving outcomes. The aim of the present study is to compare total intravenous anesthesia and postoperative sedation versus total volatile anesthesia and postoperative sedation in cardiac surgical population.


Eligibility Criteria:
Inclusion criteria:

* Patients scheduled for coronary artery bypass graft surgery with good ventricular function (grade 1-2 ventricle)
* Signed informed consent

Exclusion criteria:

* Patients undergoing valvular surgery
* Severe kidney or liver disease (creatinine \> 2.5mg.dL-1 and bilirubin \> 2 mg.dL-1)
* Patients with known hypersensitivity to any of the trial drugs (propofol, volatile anesthetics), e.g. propofol allergy or malignant hyperthermia (induced by volatile anesthetics)
* Patient with poorly controlled diabetes or on oral anti-diabetic medication (inhibit preconditioning caused by volatile anesthetics)
Retrospective Study of Outcomes With 3 mm Implant for Percutaneous BAHS Procedures

This retrospective study is conducted to gain more knowledge on use and complications of 3mm long implants used in percutaneous (through the skin) bone-anchored hearing system (BAHS) surgeries in adults. Patients included have already been treated and recieved an implant with the wide diameter (Ø: 4.5 mm) design, either of 3- or 4mm length. The main purpose of the study is to investigate implant survival three months after implantation.

BAHS systems are intended for patients with conductive or mixed hearing loss, and for patients with single-sided deafness. In BAHS surgery, an implant - coupled to a skin-penetrating abutment - is implanted in the bone behind the ear and is later loaded with a sound processor. The sound processor transforms sound waves to sound vibrations that are transferred through the skull bone to the inner ear(s)/cochlea. Thus, sound can be transmitted directly to the cochlea and bypass any problems in the ear canal or middle ear. Today, more than 400,000 implantations have been made around the world and the long-term success rate of BAHS surgery is high, with a low rate of major complications.

Over the years, both implant design and surgical techniques have developed, with improved patient outcomes as a result. Wider diameter implants, 4.5mm in diameter, increased the implant stability and have become standard. The implants exist in two different lengths, 3- and 4mm, to accomodate for different bone thickness. The shorter implant has primarily been used for (young) children and for adults with thinner bone. The aim of this restrospective study is to investigate the outcomes after implantation of a 3mm implant in an adult population.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient (≥19 years) receiving percutaneous BAHS treatment using an implant with the wide diameter (Ø: 4.5 mm) design.

Exclusion Criteria:

* Patient undergoing re-implantation due to previous failure of osseointegration or other spontaneous implant loss.
* Patient undergoing conversions from passive transcutaneous devices (i.e. BAHA Attract) to active percutaneous devices (using an abutment), using the same implant for attachment.
Evaluation of Tele-expertise for Inmates With a Dermatological Lesion

The purpose of this study is to determine whether Tele-expertise would be effective and cost-effective by reducing the number of secure transportations for inmates in need of a dermatological consultation


Eligibility Criteria:
Inclusion Criteria:

* Dermatological expertise required

Exclusion Criteria:

* None
Double-Blind, Randomized, Dose Ranging Study of Alferon LDO (Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived)) in HIV+ Subjects

To conduct a double-blind, randomized, dose ranging study of an orally administered low dose interferon alfa-n3 (IFN-An3) immunomodulator in the treatment of symptomatic HIV+ subjects.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Zidovudine (AZT).
* Didanosine (ddI)

Patients must have:

* Seropositivity to HIV-1 by ELISA and Western blot.
* At least 1 of the HIV-related clinical symptoms or opportunistic infections listed in protocol.
* Written informed consent.
* If already on zidovudine (AZT) or didanosine (ddI), must have been on this therapy for at least 75 of the 90 days prior to study entry.

Prior Medication:

Allowed:

* Zidovudine (AZT).
* Didanosine (ddI)

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Major active opportunistic infection requiring active care within 2 weeks of study entry.
* Evidence of chronic hepatitis with severe liver dysfunction:
* albumin \< 2 g/dl and SGOT or SGPT \> 5 x upper limit of normal prothrombin time \> 1.5 x upper limit of normal).
* Other active gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular, neurologic, or psychiatric disorder.
* Transfusion dependency defined as requiring \> 1 unit of packed red blood cells (RBC) per month within 3 months prior to study entry.

Concurrent Medication:

Excluded:

* Experimental medications other than didanosine (ddI).
* Chronic prophylactic use of any topical or systemic fungal medication such as ketoconazole, fluconazole, or clotrimazole.
* Chronic prophylactic use of any topical or systemic anti-viral medication such as acyclovir or ganciclovir except zidovudine (AZT) or didanosine (ddI).

Patients with the following are excluded:

* Asymptomatic at study entry.
* Presence of antibodies to interferon due to prior therapy.
* Hospitalization within 2 weeks of study entry.
* Transfusion dependency.
* Unwilling or unable to give informed consent.
* Evidence of any concurrent organ dysfunction listed in Exclusion Co-Existing Conditions.
* Unlikely or unable to comply with the requirements of the protocol.

Prior Medication:

Excluded within 6 weeks of study entry:

* Interferons.
* Excluded within 45 days of study entry:
* Immunosuppressive agents.
* Chemotherapy.
* Steroids.
* Immunomodulators.
* Isoprinosine.
* BCG vaccine.

Prior Treatment:

Excluded within 2 weeks of study entry:

* Hospitalization.

Active intravenous (IV) drug abuse.