cyrilzakka/clinical-trials huggingface dataset:
Effect of Edaravone on Radiation-induced Temporal Lobe Necrosis

It is hypothesized that excessive generation of free radicals involves in the pathogenesis of radiation-induced brain necrosis. This study therefore evaluated the effect of free radical scavenger, edaravone, on radiation-induced temporal lobe necrosis (TLN) in patients with nasopharyngeal carcinoma (NPC) after radiotherapy.

Radiation-induced temporal lobe necrosis (TLN) is the most serious sequelae of radiotherapy and impairs the patients' quality of life profoundly. Steroid is one of the conventional treatment methods for TLN. However, its response rate was still not so satisfactory (about 30%-35%).The mechanism of TLN is under exploring and not completely understood. It has been proposed recently that chronic oxidative stress and inflammation involve in the pathogenesis of radiation-induced late normal tissue injury.

Edaravone(3-methyl-1-phenyl-2-pyrazolin-5-one), which is proved to be an excellent free radical scavenger, has been applied to a wide range of oxidative stress-related diseases.Thus, it may exert a therapeutic effect on radiation-induced temporal lobe necrosis. To support this hypothesis, the investigators carried out a randomized study of combining edaravone with common fundamental management versus common fundamental therapy in patients with TLN, and analyzed the Late Effects of Normal Tissues -Subjective, Objective, Management, Analytic (LENT/SOMA) scale before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* ①Patients must have received radiation therapy for histologically confirmed nasopharyngeal carcinoma.

  * Prior irradiation \>/= 6 months prior to study entry.

    * Radiographic evidence to support the diagnosis of radiation-induced temporal lobe necrosis without tumor recurrence(15).

      * Age\>/= 18 years.

        * No evidence of very high intracranial pressure that suggests brain hernia and need surgery.

          * Fertile women who are willing to take contraception during the trial.

            * Routine laboratory studies with bilirubin \</=2 \* upper limits of normal (ULN), aspartate aminotransferase (AST or SGOT) \< 2 \* ULN, creatinine \<1.5 \* ULN, red-cell count \>/= 4,000 per cubic millimeter; white-cell count \>/=1500 per cubic millimeter, platelets \>/= 75,000 per cubic millimeter; Hb \>/=9.0. prothrombin time(PT), activated partial thromboplastin time(APTT),international normalized ratio(INR) in a normal range.

              * Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

* ①Tumor recurrence or metastases.

  * Diseases of central nervous system, such as cerebral vascular events, inflammatory, degenerative disease, and significant cardiovascular diseases.

    * Severe systemic diseases.

      * History of anaphylactic response to edaravone.
Spinal Manipulation With Laser Therapy Versus Dry Needling in Chronic Lower Backache

To determine the effectiveness of spinal manipulation with laser therapy versus dry needling for pain, disability and fear of movement in chronic low backache


Eligibility Criteria:
Inclusion Criteria:

* Those patients will be included in the study who have chronic low back pain (12 week duration).

both genders aged 18-60 years low back pain

Exclusion Criteria:

* Those patients will be excluded in the study who have needle phobia, any infection, cancer, dermal changings, heart transplant, pregnancy, rheumatic fever(25)fracture, cauda equina syndrome, arrhythmia, sensory deficiency, mental illness, surgery, osteoporosis, low term use of steroid
Evaluation of the Performance of AIR OPTIX® COLORS

The purpose of this study was to assess the ocular response to and performance of the cosmetically printed silicone hydrogel contact lens AIR OPTIX® COLORS compared to FRESHLOOK® COLORBLENDS.

The study was conducted in two phases. Phase 1 was an adaptation phase where participants wore AIR OPTIX® AQUA contact lenses bilaterally (same product in both eyes) on a daily wear basis for 1 week. In Phase 2, participants wore AIR OPTIX® COLORS and FRESHLOOK® COLORBLENDS contact lenses contralaterally (different product in each eye) on a daily wear basis for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Full legal capacity to volunteer;
* Read and sign information and consent letter;
* Willing and able to follow instructions and maintain the appointment schedule;
* Ocular examination in the last two years;
* Currently wears soft contact lenses on a daily wear basis;
* Contact lens prescription between -1.50 diopters and -5.00 diopters;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any ocular disease;
* Any systemic condition that may affect a study outcome variable;
* Any systemic or topical medications that may affect ocular health;
* Known sensitivity to the diagnostic pharmaceuticals used in the study;
* Unable to achieve an acceptable fit with the study lenses;
* Anisometropia \>1.00 diopter or astigmatism \>0.75 diopter;
* Use of lubricating/rewetting eye drops.
* Other protocol-defined exclusion criteria may apply.
Evaluating Clinical Acceptance of a NPWT Wound Care System

Determine if use of the Medela Invia Motion NPWT system supports acceptable progress towards the goal of therapy when treating patients with a variety of wound types during the evaluation period.

The primary objective of this study is to determine acceptable progress towards the goal of therapy for a diabetic foot ulcers (DFU) and pressure Injuries/ulcers (PI/PU) wounds when using the Medela Invia Motion Endure NPWT system during 4-week study duration.

Goal of therapy will be defined by the physician according to initial assessment:

Endpoints (dependent on goal of therapy):

* Decrease in wound volume
* Decrease in size of the tunneling area
* Decrease in size of undermining
* Decrease in amount of slough
* Increase in granulation tissue
* The wound bed is progressing acceptably towards a transition to another treatment modality such as Moist Wound Healing (MWH), surgical closure, or a flap or graft.

\*\*Study endpoint will be determined by physician at the time of enrollment, when the goal of therapy is documented\*\*

B. Secondary Objectives

* To evaluate the ease of use from clinicians.
* To evaluate overall satisfaction from clinicians. C. Tertiary Objectives
* Adequate management of the exudate

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects ≥18 years of age.
* Signed, informed consent by patient or LAR within 72 hours of admission to burn center.
* Patient is determined to be in need of NPWT for treatment of a diabetic foot ulcer, pressure injuries/pressure ulcer.
* Patient is comfortable (e.g. not in pain)
* Patient is willing and able to adhere to treatment protocol.

Exclusion Criteria:

* Patient not willing to comply with f/u clinic visits.
* Subjects with

  * Necrotic tissue with eschar present
  * Untreated osteomyelitis
  * Non-enteric and unexplored fistulas
  * Malignancy in wound
  * Exposed vasculature
  * Exposed nerves
  * Exposed anastomotic site of blood vessels or bypasses
  * Exposed organs
* Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
* Patients with concurrent conditions or co-morbidities that in the opinion of the investigator may compromise patient safety or study objectives.
The BWH Wellness Project

The investigators propose a 24 week program to provide proof-of-principle evidence that financial incentives stimulate Brigham and Women's Hospital (BWH) employees to be more physically active.

Participants wear a Fitbit Flex accelerometer for at least six months. During the first two weeks, they are paid simply for wearing the Fitbit. After that, they are regularly paid for either meeting CDC guidelines for moderate physical activity (PA) or increasing their PA by at least 10% from the preceding week. Moderate PA is defined as walking for at least 100 steps per minute for at least 10 minutes at a time. One minute of vigorous PA, over 175 steps/minute, counts as two minutes of moderate PA.

In addition to weekly bonuses, there are also bonuses for achieving all goals in 1 month, 3 month, and 6 month intervals. In cases where all three team members received a bonus, their bonuses are doubled. Individuals also fill out weekly questionnaires about their work attendance, as well as longer questionnaires at baseline, three months, and six months.

Eligibility Criteria:
Inclusion Criteria:

* Brigham and Women's Hospital employee
* Reported less than 30 minutes of exercise per week
* Use a computer daily at work or home
* Willing to wear a pedometer, undergo health screening, and complete occasional questionnaires

Exclusion Criteria:

* Occupation: Physician, nurse or other clinician
* Self-reported pregnancy at baseline
Efficacy and Safety of 8-weeks of Glecaprevir/Pibrentasvir in Treatment-Naïve Adults With HCV Genotype 1-6 and Aspartate Aminotransferase to Platelet Ratio Index (APRI) ≤1

A study to evaluate the efficacy and safety of glecaprevir(GLE)/pibrentasvir(PIB) in treatment-naïve participants with chronic hepatitis C virus (HCV) genotypes 1-6 infection and with an aspartate aminotransferase to platelet ratio index (APRI) of less than or equal to 1.


Eligibility Criteria:
Inclusion Criteria:

* Hepatitis C virus (HCV) genotype (GT) 1, 2, 3, 4, 5, or 6 infection. Mixed GT and indeterminate GT may be acceptable.
* Aspartate aminotransferase (AST) to platelet ratio index (APRI) score of less than or equal to 1, at time of screening.
* Does not have current active hepatitis B virus infection defined as:

  * positive hepatitis B surface antigen (HBsAg), OR
  * hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \> lower limit of quantification (LLOQ) in subjects with isolated positive anti-hepatitis B core (HBc) (i.e., negative HBsAg and anti-hepatitis B surface\[HBs\])
* Platelets ≥ 150,000 cells/mm³
* Albumin ≥ lower limit of normal (LLN)
* Positive anti-HCV antibody (Ab) AND plasma HCV ribonucleic acid (RNA) viral load ≥ 1,000 IU/mL at Screening and for at least 6 months before Screening.
* No past history/evidence of cirrhosis.
* No history of hepatocellular carcinoma.
* Hepatitis C virus treatment-naïve (had not received a single dose of any approved or investigational anti-HCV medication).
* If female, the subject must not be pregnant, breastfeeding, or considering becoming pregnant during the study and for 30 days after the last dose of study drug.
Effect of Intervention With Diet and Physical Activity in Obese Pregnant Women

Purpose: To evaluate if lifestyle intervention (diet and exercise) can reduce maternal weight gain, the incidence of pregnancy complications and minimize the number of macrosomic infants.

Obese pregnant women with a BMI\>30 are randomized to Diet + Exercise, Exercise or control (1:1:1) in order to reduce maternal weight gain to less than 5 kg during pregnancy.

The effect on the children of mothers in this study is evaluated in the study: Is it possible to reduce the Number of Macrosomic Infants With Abundant Fat Tissue by Lifestyle Intervention during Pregnancy (NCT01235676)

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* BMI \> 30
* Singleton pregnancy
* Must speak and understand Danish

Exclusion Criteria:

* Alcohol or drug abuse
* Diabetes type I or other critical medical disease.
Study of Whole-brain Irradiation With Chloroquine for Brain Metastases

Background and purposes:Chloroquine (CLQ), an antimalarial drug, has a lysosomatrophic effect associate with increase the sensibility of Radiation through leakage of hidroliticenzimes, increase of apoptosis, autophagy mediated by lysosomalhidrolases and increase of oxidative stress "in vitro". In this phase II study we evaluated the efficacy and safety as radiosensitizing of the Chloroquine plus concomitant 30 Gray (Gy) of Whole-brain irradiation (WBI)in patients with brain metastases (BM) from solid tumors.

Seventy-three eligible patients were randomized. Thirty-nine patients received WBI (30 Gy in 10 fractions over 2 weeks) concomitant with 150 mg of CLQ for 4 weeks (the CLQ group). Thirty-four patients received the same schedule of WBI concomitant with a placebo for 4 weeks (the control arm). All the patients were evaluated for quality of life (QoL) using the EORTC QLQ-C30 questionnaire (Mexican version) before beginning radiotherapy and one month later.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 80 years of age
* At leat one brain metastasis MRI
* KPS 70 or more
* RTOG-RPA I or II
* Basic Laboratory requirements

Exclusion Criteria:

* Candidates for radiosurgery, neurosurgery
* Patients treated with radiotherapy before entered to the study
Comparison of Denervation Techniques for the Treatment of Knee Osteoarthritis: Continuous Ablative Radiofrequency Vs. Chemical Denervation with Absolute Alcohol

This randomized clinical trial compares two minimally invasive treatments for knee osteoarthritis pain that has not responded to conventional therapies. The study evaluates the effectiveness and safety of continuous ablative radiofrequency, which uses heat energy to disrupt pain signals, and chemical denervation with absolute alcohol, which involves an injection to reduce pain transmission. Participants will be randomly assigned to one of the treatments, and their pain levels, mobility, and quality of life will be monitored over time to determine which method provides better pain relief.

This randomized clinical trial compares continuous ablative radiofrequency and chemical denervation with absolute alcohol for pain relief in patients with knee osteoarthritis refractory to conventional treatments. Participants will be randomly assigned to one of the two procedures, with outcomes assessed based on pain reduction, functional improvement, quality of life, and safety. Follow-ups will be conducted for up to six months to evaluate the durability of pain relief, providing evidence to guide clinical management of chronic knee osteoarthritis pain.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged ≥ 18 years.
* Knee pain for more than 3 months.
* Clinical and imaging-confirmed diagnosis of knee osteoarthritis, based on X-ray, ultrasound, or magnetic resonance imaging (MRI).

Exclusion Criteria:

* History of major joint interventions, such as previous knee surgery or arthroplasty.
* Severe joint effusion.
* Coagulation disorders or other clinical contraindications for the procedure.
* Uncontrolled comorbidities that increase procedural risk.
* Body mass index (BMI) \> 35.
* Cognitive impairment that affects the ability to understand and respond to pain assessment instruments.
A Novel Selective Block of the Suprascapular Nerve

Patients who receive the lateral and sagittal infraclavicular block (LSIB) tend to supinate their hand and forearm which may hamper optimal positioning for surgery of the dorsal side of the hand. The investigators think that this supination is caused by lateral rotation in the shoulder. The main lateral rotator of the shoulder is the infraspinatus muscle, which is innervated by the suprascapular nerve (SSN).The investigators hypothesized that optimal positioning of the hand for surgery on the dorsal side of the hand may be achieved by performing a SSN block (SSNB) in addition to the LSIB.

According to the hypothesis the investigators will perform a double blind , placebo controlled study to answer the research question above.

Eligibility Criteria:
Inclusion Criteria:

* Patients with American Society of Anesthesiologists physical status (ASA) I- III
* age between 18 and 70 years
* body mass index between 20 and 36 kg/m2 scheduled for elective hand surgery.

Exclusion Criteria:

We will measure the angle between wrist and horizontal plane while the patient is supine and the extended arm 75° abducted.

* Patient who are not able to pronate the hand ≤15° before block performance, will be excluded from the study.
* Patients will also be excluded if they are pregnant, have contraindications to regional anesthesia, coagulation disorder, allergy to local anesthetics (LA), atrioventricular block, peripheral neuropathy or drug-treated diabetes.
* Patients using other anticoagulation drugs than acetylsalicylic acids or dipyridamol will be excluded.
Extension to a Pivotal Study of Sensory Stimulation in Alzheimer's Disease (OLE Hope Study, CA-0015)

This is an open-label extension for a multicenter, randomized, double-blind, sham-controlled, adaptive design pivotal study.

Participants who complete the Hope Study (CA-0011) will be eligible to consent for screening to enroll in the OLE Hope Study (CA-0015). All participants will be treated with an Active Sensory Stimulation System (GS120) for 60 minutes daily for up to 12 months. There will be no Sham treatment group or randomization involved in this study.

This is an open-label extension for a multicenter, randomized, double-blind, sham-controlled, adaptive design pivotal study. Participants who complete the Hope Study (CA-0011) will be eligible to consent for screening to enroll in the OLE Hope Study (CA-0015). All participants will be treated with an Active Sensory Stimulation System (GS120) for 60 minutes daily for up to 12 months. There will be no Sham treatment group or randomization involved in this study.

Up to approximately 402 participants will complete the Hope Study and be offered participation in the OLE Hope Study at up to approximately 70 clinical sites.

The objective of the study will be to assess efficacy of gamma sensory stimulation (visual and audio) in slowing disease progression in the Active-Active group versus Active-Sham group for subjects with mild to moderate AD as measured functionally by the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) assessment and a combined statistical test (CST) for ADCS-ADL and the Mini-Mental State Exam (MMSE).

Participants will be treated with the Sensory Stimulation System (GS120) for 60 minutes daily for up to 12 months with Active device settings. Each participant will be involved in the study for up to 13 months: approximately 12 months of treatment and 1 month of safety follow-up.The visits in the study include: a Screening/Enrollment visit (Day 0), followed by telephone training on device receipt, a clinic visit at 12 months and a telephone visit at 6 and 13 months.

Eligibility Criteria:
Inclusion Criteria:

* Randomized and completed 12-months of participation in the Hope Study (CA-0011)
* Non-childbearing potential or using adequate birth control
* Available/consenting Study Partner

Exclusion Criteria:

* Insufficient adherence to treatment in the Hope Study (CA-0011)
* Living in continuous care nursing home (assisted living permitted)
* Initiating or ongoing treatment with any of the following during study participation:

  * Immunomodulators or passive immunotherapies for AD (ie, monoclonal antibodies)
  * Memantine (Namenda or Namzaric)
  * Nootropic drugs except stable acetylcholinesterase inhibitors

For more information about the Hope Study (CA-0011) that participants in this study complete first, please see: https://www.hopestudyforad.com/

or the Hope Study ClinicalTrials.gov posting here: https://clinicaltrials.gov/study/NCT05637801
Time of Intravenous Acetaminophen Administration

The purpose of the study is to examine the effects of timing of administration of intravenous (IV) acetaminophen and how timing relates to analgesic efficacy as measured by postoperative pain scores. A maximum of 138 patients meeting inclusion criteria who present for a scheduled total hip replacement under general anesthesia will be randomized into one of two arms: 1) the pre-closure group will receive the first dose administered upon onset of skin closure, 2) the preemptive group will receive the first dose administered within 60 minutes prior to incision. Both groups will receive subsequent doses every 6 hours x 24 hours.

The purpose of the study is to examine the effects of timing of administration of intravenous (IV) acetaminophen and how timing relates to analgesic efficacy as measured by postoperative pain scores. A maximum of 138 patients meeting inclusion criteria who present for a scheduled total hip replacement under general anesthesia will be randomized into one of two arms: 1) the closure group will receive the first dose of one gram of intravenous acetaminophen administered upon onset of skin closure, 2) the preemptive group will receive the first dose of one gram of intravenous acetaminophen administered within 60 minutes prior to incision. Both groups will receive subsequent doses of one gram of intravenous acetaminophen every 6 hours x 24 hours. The maximum dose in a 24 hour period will not exceed 4 grams according to FDA recommendations.

Eligibility Criteria:
Inclusion Criteria:

* Patients 30-75 years of age weighing ≥55 kg scheduled for elective total hip arthroplasty performed under general anesthesia will be included. As determined by the anesthesia team assigned to the case, eligible patients will also be assigned ASA physical status of I, II, or III and deemed capable of reporting their perceived pain using numeric pain scales and capable of operating a patient controlled anesthesia (PCA) device.

Exclusion Criteria:

* Exclusion criteria include known allergy, hypersensitivity, or contraindication to acetaminophen, history of alcohol or drug abuse, prisoners, emergency THAs, patients with chronic malnutrition or a body mass index (BMI) \< 18 kg/m2 and non-English speaking patients. Additional exclusion criteria include impaired liver function defined as AST and ALT each ≥ twice normal limits and renal dysfunction (creatinine \>2.0 mg/dl).
A Cone Beam Computed Tomographic Evaluation of Healing of Apicomarginal Defects Using Autologous Platelet Aggregates

This study will evaluate the effect of PRF (platelet rich fibrin) on the healing of apicomarginal defects. Healing of the defects will be assessed 2 dimensionaly by periapical radiograph and 3 dimensionaly using CBCT.

Patients with apicomarginal defects as per the inclusion criteria will be randomly divided into two groups - (1) Test group - The denuded root surface will be covered by PRF (Choukron's method) and (2) Control group -No use of autologous platelet aggregate during periapical surgery. Radiographic and clinical healing will be assessed after 12 months, 2D healing will be assessed by Rud and Molven criteria and 3D healing will be assessed by Modified Penn 3D criteria.The clinical parameters recorded including periodontal pocket depth (PD), clinical attachment level (CAL) and gingival margin position (GMP) will be measured on buccal aspect of the interproximal space and mid buccal aspect of the involved teeth using Williams 'O' periodontal probe.Routine examination procedure will be used to evaluate any evidence of signs and/or symptoms.

Eligibility Criteria:
Inclusion Criteria:

* A negative response to vitality tests with radiographic evidence of periapical radiolucency with no general medical contraindications for oral surgical procedures.
* Apicomarginal communication having probing depth \> 6mm.
* Patients with no general medical contraindications for oral surgical procedures.
* Recurrent episodes of purulent discharge.
* Failed previous root canal treatment.
* Failed previous surgery with persistent bony lesion.
* Adequate final restoration with no clinical evidence of coronal leakage.

Exclusion Criteria:

* Clinical or radiographic evidence of root fracture.
* Resorptive processes involving more than apical third of the root.
* Any systemic disease contraindicating oral surgery including uncontrolled diabetes and pregnancy.
* Any condition effecting rate of healing like smoking.