cyrilzakka/clinical-trials huggingface dataset:
The Effect of Lateral Wedge Insole for Knee Osteoarthritis Patient in Plantar Pressure, Quadriceps Thickness, Gait and Walking Speed

Investigators would let knee osteoarthritis patient dressing lateral wedge insole and evaluate the effect for foot pressure modification, quadriceps thickness detected with ultrasound and gait. Investigators would made the patient in control group dressing ordinary insole.

Knee osteoarthritis is one of the most popular disease affected elderly people and made them discomfort. There was no study using foot pressure as a parameter about lateral wedge insole intervention for the knee osteoarthritis patient. The purpose of this study was to investigate the effect of lateral wedge insole for the patient of knee osteoarthritis. During total period of 12 weeks for the study, investigators randomized the patient into experimental and control group. Then investigators evaluated the patient's foot pressure, quadriceps thickness, stride length, stride width, walking speed, pain scale and daily function before intervention, 4th weeks, 8th weeks and 12th weeks. Investigators would use pressure insole designed in the Industrial Technology Research Institute in Taiwan. The portable device used in this study maybe suitable for evaluation of other lower limb disease. There were studies evaluating elderly people dysfunction, critical illness muscle atrophy or knee joint disease with ultrasound detected quadriceps thickness. But there was no study about the correlation between foot pressure and quadriceps thickness for evaluating the effect of lateral wedge insole. Investigators hoped to make a new model for evaluating lower limbs disorder in the future.

Eligibility Criteria:
Inclusion Criteria:

* Knee osteoarthritis patients
* Medial knee pain

Exclusion Criteria:

* Unable to walk independently
* Ambulation with device
* Any neurologic disease
* Rheumatoid arthritis, gouty arthritis
* History of lower limbs fracture
* History of operation for lower limbs
* Any infectious disease
Comparison of Hepatic Intraarterial Versus Systemic Intravenous 68Ga-PSMA PET/CT for Detection of Hepatocellular Carcinoma

This phase 0/1 study evaluates intraarterial administration of gallium Ga 68 gozetotide (68Ga-PSMA) for the detection of prostate-specific membrane antigen (PSMA) positive liver cancer by positron emission tomography (PET)/computed tomography (CT). 68Ga-PSMA is an imaging agent used with PET/CT scans to locate PSMA positive lesions. This study evaluates intraarterial administration of this agent, compared to intravenous administration.

PRIMARY OBJECTIVE:

I. To determine the tumor radiotracer uptake (first pass effect or regional advantage) of direct hepatic intraarterial (I.A.) versus systemic intravenous (I.V.) 68Ga-PSMA in patients with PSMA+ hepatocellular carcinoma (HCC) by PET/CT.

OUTLINE:

Patients undergoing clinically indicated hepatic artery embolization will receive 68Ga-PSMA intraarterially (IA) over 5 minutes. After 60-90 minutes, patients undergo PET/CT scan over 1 hour.

Eligibility Criteria:
Inclusion Criteria:

* Patients with either an imaging diagnosis of HCC by CT or magnetic resonance imaging (MRI) (Liver Imaging and Reporting Data System 5 \[LI-RADS 5\]) confirmed by a board-certified abdominal radiologist, or with biopsy-proven HCC
* Already enrolled in ongoing Transform the Practice or Department of Defense 68Ga-PSMA studies
* PSMA avid HCC detected by 68Ga-PSMA PET/CT after intravenous administration of 68Ga-PSMA confirmed by a board certified nuclear radiologist
* Undergoing planned hepatic artery embolization (HAE) per standard clinical care
* Male or female with age greater than 18 years, with the capacity and willingness to provide a written informed consent

Exclusion Criteria:

* Subjects requiring emergent surgery for a ruptured/bleeding HCC
* Pregnant and/or breast-feeding subjects. A negative pregnancy test within 48 hours of the PET scan
* Subjects with higher than the weight/size limitations of PET/CT scanner
Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir and Ribavirin for Hepatitis C Virus Genotype 4 Patients

enrolled participants were treated orally with SOF plus a fixed dose combination of OBV/PTV/r plus RBV.

Enrolled participants were treated orally with SOF plus a fixed dose combination of Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir plus Ribavirin (OBV/PTV/r plus RBV), which was administered orally based on the participants' tolerability. The primary end point was a sustained virological response (HCV RNA level \< 15 IU/ mL), observed 12 weeks after the end of the treatment (SVR12).

Eligibility Criteria:
Inclusion Criteria:

* The experienced participants who were treated previously with (SOF/DCV) , (SOF/SMV), (SOF/RBV), or (SOF/pegINF/RBV).
* The presence of compensated liver cirrhosis was documented by ultrasonographic examination, liver biopsy, results of Fibroscan or FIB-4 score, and laboratory markers, like FIB-4 \> 3.25 (advanced fibrosis or cirrhosis), albumin \< 3.5, total bilirubin \> 1.2, and also confirmed by clinical characteristics such as lower limb edema, splenomegaly, esophageal varices.

Exclusion Criteria:

* liver disease of non-HCV GT4 etiology, coinfection with hepatitis B or HIV
* poorly controlled diabetes (HbA1C \> 8)
* participants, hepatocellular carcinoma, a history of extrahepatic malignancy in the 5 years prior to the study
* renal failure
* evidence of hepatic decompensation
* blood picture abnormalities such as anemia (hemoglobin concentration of \< 10 g/dL)
* thrombocytopenia (platelets count \< 50,000 cells/mm3).
* major severe illness such as congestive heart failure and respiratory failure.
Effect of the LumbaCure® Intervention on Elderly Patients Suffering From cLBP.

The goal of this investigation is to evaluate the safety and efficacy of the LumbaCure® device in elderly people suffering from low back pain. The study is being carried out at several sites, in nursing homes, in order to reach the elderly patients most at risk of a sedentary lifestyle.


Eligibility Criteria:
Inclusion Criteria:

* Chronic or sub-acute low back pain (without "red flag")
* The subject, a resident or worker at the investigation site (nursing home), over 60 years of age
* Ability to communicate with the physiotherapist.
* Ability to remain in a sitting position for at least 10 minutes.
* A level of back pain \> 2 on the numerical pain rating scale

Exclusion Criteria:

* Suspected or confirmed serious pathology (infection, fracture, cancer, inflammatory arthritis, ....) related to the back/spine.
* Body weight \> 120 kg
* Subject is non-ambulatory or has severely reduced mobility.
* Dominant component of radicular pain (common lumbago with distal radiation below the knee)
* Radiculopathy
* Severe cardiorespiratory disease
* Dementia or significant cognitive impairment that prevents the participant from giving consent, completing study questionnaires or complying with recommendations.
* Fracture or operation less than 3 months old of the spine, pelvis, hip or leg bones.
* Known vertebral pathology other than osteoarthritis.
* Major neurological disease, movement or motor neuron disorders
* Fibromyalgia or other systemic rheumatic disease
* Recent history of stroke or heart failure, unstable heart condition
* Uncontrolled substance abuse disorders
* Invasive procedures to relieve pain in the last 3 months
* Acute or terminal illness
* Any other medical condition considered by the study team to be a contraindication to the study.
Comparison of 7-day and 14-day Bismuth Based Quadruple Therapy for Secondary Helicobacter Pylori Eradication

At present, triple therapy are recommended by various guidelines for the treatment of Helicobacter pylori (H. pylori) infection. Recent studies have shown worldwide high treatment failure rates with one week first line clarithromycin based triple therapy necessitating salvage strategy to eradicate H. pylori in primary treatment failure. However, the exact duration of bismuth based second line treatment is not determined. Therefore, the investigators performed this study to evaluate the eradication rate of 1 or 2-week quadruple regimen as a second-line therapy.


Eligibility Criteria:
Inclusion Criteria:

* H. pylori infection
* Aged between 18-80 years
* Are willing to received eradication therapy for H. pylori

Exclusion Criteria:

* Children and teenagers aged less than 18 years or over 80 years
* Previous eradication therapy for H. pylori
* History of gastrectomy
* Previous allergic reaction to antibiotics
* Use of prompt pump inhibitors and antibiotics in the recent 4 weeks
* Active upper GI bleeding in the recent 1 week
* Contraindication to treatment drugs
* Pregnant or lactating women
* Severe concurrent disease or malignancy
Expansion of the T1DES Pilot to a Public Hospital

Diabetes distress has been identified as one of the largest contributors to the racial disparity in glycemic control that disproportionately burdens Black patients ages 18-30 years with type 1 diabetes (T1D). In order to combat this issue, this study assesses the feasibility of the culturally tailored intervention T1DES and evaluates the effect of the T1DES intervention on diabetes outcomes in a pilot randomized clinical trial among Black young adults with T1D.

This research focuses on the unique needs of Black young adults aged 18-30 years to address a critical gap in the research and clinical care. The goal is to test the feasibility and preliminary efficacy of a culturally adapted and tailored intervention to enhance diabetes management strategies among Black young adults with T1D, addressing the pervasive racial disparity in health outcomes for this population.

The specific aims for this study are to:

Aim 1: Assess feasibility of the culturally tailored intervention T1DES by measuring intervention acceptability, demand (retention, completed \> 80% of sessions), practicality, and implementation fidelity through participant surveys and key informant interviews with participants and the health care delivery team.

Aim 2: Evaluate the effect of the T1DES intervention on diabetes outcomes in a pilot randomized clinical trial among N=40 Black young adults age 18-30 years with T1D and elevated HbA1c (\>7.5%) by comparing changes in HbA1c, diabetes distress, and self-management from baseline to 6-months postbaseline among participants randomized to T1DES compared to the diabetes education-only control condition.

The goal of this study is to provide diabetes education and emotion regulation support tailored for Black young adults' experiences that will result in sustained glycemic control and can be incorporated into adult endocrinology practices.

Eligibility Criteria:
Inclusion Criteria:

* Grady Health System Patient
* Aged 18 - 30 years
* Confirmed diagnosis of Type 1 diabetes
* Hemoglobin A1c \> 7.5 at time of enrollment
* a cell phone able to send/receive text messages
* Self-reported race of Black or African American
* Ability to read in English and provide informed consent

Exclusion Criteria:

* Developmental delay or other cognitive impairment that would render the participant unable to provide informed consent
* Subjects with visual impairment or have severe hearing or other physical disabilities that would be a barrier for participating in-group or web sessions
* Diabetes complications that would preclude participation in the study
Sevoflurane Decreases the Risk of Postoperative Delirium After Cerebral Hypoxemia During Surgery

The aim of this study is to distinguish possible differences in frequency of delirium after Volatile Induction and Maintenance of Anesthesia and Total Intravenous Anesthesia in case of undeliberate cerebral desaturation during non-cardiac surgery.

The aim of the present study is to investigate whether in non-cardiac surgery the frequency of POD after intraoperative undeliberate cerebral saturation could be modulated by the choice of the anesthetic strategy (Volatile Induction and Maintenance of Anesthesia \[VIMA\] and Total Intravenous Anesthesia \[TIVA\]). Based on our previous data we hypothesized that incidence of POD would be lower with VIMA compared to TIVA.

Eligibility Criteria:
Inclusion Criteria:

* class III-IV by physical status classification system of American Society of Anesthesiologist (ASA)
* history of arterial vascular disease (arterial hypertension, myocardial ischemia and/or cerebral vascular disease)
* undergoing elective non-cardiac surgery (hemicolectomy, hernioplasty, laparoscopic cholecystectomy and laparoscopic hysterectomy)

Exclusion Criteria:

* dementia
* stroke or myocardial infarction ≤ 6 months before surgery
* oncological disease of T2-4N3M1 stage
Effect of Chinese Herb on Chronic Constipation for Residents in Long-Term Care Units

The purpose of our study is to improve the problem of constipation and increase the quality of long-term care by the regimen of Chinese herb prescribed by professional doctors of Chinese medicine.

Although many people regard regular defecation as important factor to maintain healthy, constipation is still a common problem in general population. According to some surveys, constipation affects approximately 50% to 73% of nursing home residents. Because the symptoms cause serious impairment of life quality, laxatives are commonly prescribed for people and over-prescribing of laxatives is also common. Despite the large sums spent on laxatives, there have been few advances in laxative treatment in the last 50 years and there have been minimal research addressing the problem. Therefore constipation was labeled as "the neglected symptoms".

There is unsatisfactory effect by currently pharmacologic therapies and preventive strategies for constipation. Contrarily, they had abundant clinical experiences and medical records for constipation in traditional Chinese medicine. So we follow the worldly trend to do the research of integrative Chinese medicine and western medicine since WHO launched the first global strategy on traditional and complementary/alternative medicine (TM/CAM) to assist countries to create a stronger evidence base on the safety, efficacy and quality of the TM/CAM products and practices. The aim of our study is to improve the problem of constipation and increase the quality of long-term care by the regimen of Chinese herb prescribed by professional doctors of Chinese medicine.

The study will be performed under randomized, double-blind, placebo controlled, parallel design. The object of this study is the residents in nursing homes. After intake of Chinese herb, improving constipation and life quality, decreasing the frequency of enema or digital maneuver, minimizing the dosage of laxatives and saving the medical expenditure will be expected.

Eligibility Criteria:
Inclusion Criteria:

* men and non-pregnant women who are at least 20 years of age;
* patients who have been adequately informed of the nature and risks of the study and who have given written informed consent prior to receiving study medication
* residents in long-term care units who meet one of the following criteria in past one month: 1. MgO \>= 1 tab tid 2.Dulcolax \>=1 tab qd 3.concurrent use of at least two categories of laxatives 4.at least once a week of enema 5.less than three times a week of bowel movement

Exclusion Criteria:

* known renal or hepatic insufficiency;
* known colorectal cancer, anal abscess, anal fistula, anal fissure, rectocele, inflammatory bowel diseases, or gastrointestinal obstruction;
* unknown cause of gastrointestinal bleeding or acute infection
* history of alcohol or drug abuser
* history of psychiatric disorders
* women who are pregnant, as determined by a urine pregnancy test
* use of an investigational drug (within 30days prior to enrollment)
* known allergies to the component of study medication
Enhancing Cognitive Control in Mild Cognitive Impairment Via Non-invasive Brain Stimulation

The overall goal of this project is to improve cognitive control abilities in adults with mild cognitive impairment (MCI) through a form of non-invasive brain stimulation, transcranial alternating current stimulation (tACS).

30 older adults aged 60-80 years with md-aMCI were randomized to 8 sessions of transcranial alternating current stimulation (tACS) with simultaneous cognitive control training (CCT). The intervention took place within the participant's home without direct researcher assistance. Half of the participants received prefrontal theta tACS during CCT and the other half received control tACS. Outcomes were assessed pre and post intervention.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Grade 12 or more education
* Normal or corrected to normal vision and hearing
* Ability to complete cognitive tasks
* Ability to cooperate and comply with all study procedures
* Ability to tolerate tACS
* Montreal Cognitive Assessment score: 17-28
* -1 z-score on immediate memory, delayed memory, fluency, processing speed, or task switch
* Self-reported memory complaint

Exclusion Criteria:

* Neurological or psychiatric disorders other than mild cognitive impairment
* Receiving investigational medications or have participated in a trial with investigational medications within last 30 days
* Family history of epilepsy
* Implanted electronic devices (e.g., pacemaker)
* Prior head trauma
* Pregnant
* IQ \< 80
* Taking cholinesterase inhibitory, memantine, or psychotropic medication
* Taking anti-depressants or anti-anxiety medication
* Color blind
* Substance abuse
* Glaucoma
* Macular degeneration
* Amblyopia (lazy eye)
* Strabismus (crossed eyes)
The Double Factor Technique: a Computer-guided Implant Surgery Technique for Fully Edentulous Patients

To overcome the limitations of the current dynamic and static Computer Assisted surgery protocols in fully edentulous patients, and combine the advantages of both approaches, a new technique has been developed, referred to as the "double factor" technique.

This study consists in a single arm observational prospective clinical study and the aim was to assess the accuracy and patient's perception and quality of life of the "double factor" technique in treating fully edentulous patients.

This is a prospective observational clinical study. Each patient enrolled in this study will be treated using the "all on four concept" using the double factor technique.

Preoperative virtual planification of dental implants on a pre-acquired cone beam computed tomography (CBCT) will be performed for each patient using the same system.

During the surgical phase, four dental implant will be placed in a fully guided approach using "the double factor technique. This technique merges the static and dynamic computer-guided surgical approach in the same surgery.

Then after the surgical procedure a PROMs questionnaire will be asked to the patients.

Finally, a postoperative CBCT will be performed and overlapped with the preoperative CBCT (with the implants planification) and implant position deviations between the planned and final position will be measured.

The study devices are CE- (Conformité Européenne, meaning European Conformity) marked products and used within their intended use.

Eligibility Criteria:
Inclusion Criteria:

* Fully edentulous patients or with terminal dentition that requires an implant supported rehabilitation
* Healthy patients ASA I and II (American Society of Anesthesiologists classification)
* Over 18 years old patients

Exclusion Criteria:

* Partially edentulous patients
* Systemic or local conditions that contraindicates dental implant surgery
The Safety and Effectiveness of ISIS 2922 in Patients With AIDS Who Have Cytomegalovirus (CMV) of the Eyes

To evaluate the efficacy and safety of ISIS 2922 in AIDS patients with Cytomegalovirus ( CMV ) retinitis who are unresponsive or intolerant to ganciclovir and/or foscarnet but are otherwise ineligible for ISIS Pharmaceuticals' controlled trials OR who have failed ISIS 2922 therapy on another controlled clinical trial.

PER 2/8/96 AMENDMENT: Patients must rollover from another ISIS 2922 controlled trial.

Patients receive intravitreal injections of ISIS 2922 at doses of either 150 or 300 mcg, depending on CMV retinitis location and extent of retinal involvement. There is a 3-week Induction period followed by at least 18 weeks of Maintenance. Induction is given on days 1, 8, and 15, and Maintenance doses are given every 14 days, beginning on day 29.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* AIDS.
* CMV retinitis in one or both eyes that was previously treated but is presently uncontrolled.
* Intolerance or resistance to other therapies.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Eligibility to participate in a controlled clinical trial of ISIS 2922.
* External ocular infection in eye to be treated.
* Other herpetic infections of the retina, toxoplasma retinochoroiditis, or other diseases of the fundus in eye to be treated.
* Ocular condition that would obstruct visualization of the posterior ocular structures in eye to be treated.
* Retinal detachment in eye to be treated.
* Known or suspected allergy to phosphorothioate oligonucleotides.
* Silicone oil in eye to be treated.
* Syphilis.
* Clinical evidence of retinal pigment epithelial stippling.
* Pseudoretinitis pigmentosa.

Concurrent Medication:

Excluded:

* Foscarnet.
* Mellaril, Stelazine, Thorazine, and Clofazimine.
* Ethambutol / fluconazole combination.
* Other investigational drugs for CMV retinitis.

Patients with the following prior conditions are excluded:

* History of surgery to correct retinal detachment in eye to be treated.
* History of ganciclovir implant for treatment of CMV retinitis.
* History of intolerance to ISIS 2922.
* History of syphilis.

Required:

* Prior CMV retinitis therapy with ganciclovir, foscarnet, or ISIS 2922.