cyrilzakka/clinical-trials huggingface dataset:
Development and Evaluation of a Cognitive Rehabilitation Program for Persons With Multiple Sclerosis

Multiple sclerosis (MS) is a progressive neurological disease that affects over 2.5 million people worldwide. Up to 50% of persons with MS (PwMS) will experience some form of cognitive impairment as a result of the disease including disturbances in memory, attention, concentration, information processing, and executive functions such as problem solving, and self-monitoring. MS-related cognitive impairments negatively affect many aspects of functioning and independent participation in everyday life. Thus, PwMS who experience cognitive impairments face a wide array of recurring barriers that pose grave challenges to carrying out everyday activities while trying to maintain multiple life roles and as they age.

Management of cognitive symptoms can be addressed through rehabilitation which has the potential to reduce disability, prevent complications of the disease, and enhance participation, independence, and quality of life. Considering the high frequency of cognitive impairments in MS and their significant, complex impact on functioning and independence, it is critical that cognitive interventions be an essential component of MS rehabilitation.

The overarching goal of this study is to develop and test a self-management, group-based cognitive rehabilitation program designed specifically for PwMS.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MS
* 18 years of age or older
* Self-report of cognitive difficulties

Exclusion Criteria:

* Exacerbation of symptoms in past 3 months
* History of TBI, CVA, epilepsy, Psychiatric condition, drug/alcohol abuse
Mesh Type in Ventral Hernia Repair

Ventral hernias are common following abdominal surgery. Currently, there is no equipoise on when synthetic and biologic meshes should be used. Among open ventral hernia repairs, half are repaired using biologic mesh while half are repaired using synthetic mesh. The investigators hypothesize that biologic mesh as opposed to synthetic mesh repair of open ventral hernia repair is associated with decreased risk of major complications one year after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled for open ventral hernia repair at LBJ General Hospital

Exclusion Criteria:

* Active infection
* Patient unlikely to survive with the next 2 years based upon surgeon judgment (i.e. metastatic cancer, end-stage cirrhosis)
* Patient surgeon would not normally place a prosthetic (e.g. planned second surgery such as ostomy takedown)
* Patient unlikely to follow-up (i.e. no phone)
Pharmacokinetics of Sugammadex in Reversal of Vecuronium-induced Neuromuscular Blockade in Patients During Laparoscopic Surgery

The purpose of this study is to illustrate pharmacokinetics of sugammadex in reversal of vecuronium-induced neuromuscular blockade in patients during laparoscopic surgery

48 patients undergoing laparoscopic surgery were divided into 3 groups according to body mass index (BMI), including normal weight group(A group,n=16,18.5kg/m² ≤ BMI ≤ 24.9kg/m²),obese group (B group, n=16, 25≤BMI≤39.9kg/m²) and morbidly obese group (C group, n=16, BMI≥40kg/m²).

Vecuronium was continuous infusing to maintain moderate neuromuscular blockade during the laparoscopic surgery and stopped infusing after the laparoscopic procedure. A single dose administration of sugammadex (Sug) 2.0mg/kg according to ideal body weight (IBW) was given at the reappearance of the second twitch of the train-of-four (TOF) response.

On one hand, venous blood samples were obtained before administration of Sug and at 2, 3, 5, 10, 15, 20, 30, 60 minutes and 2, 4, 6, 8 hours after administration of Sug to determine plasma concentration of Sug using HPLC-MS. On the other hand, time from start of administration of Sug to recovery of TOF ratio to 0.9 and other clinical indicators were also recorded.

Eligibility Criteria:
Inclusion Criteria:

1. ASA: Ⅰ\~Ⅲ
2. BMI≥25kg/m²
3. Patients receiving bariatric surgery.

Exclusion Criteria:

1. Pregnant or lactating women
2. Neuromuscular diseases
3. Malignant hyperthermia or allergic history during general anesthesia
4. Drugs that react with rocuronium and vecuronium were taken
A Study of SHR-A1811 Combined With Capecitabine in Treatment of Unresectable or Metastatic Breast Cancer With Low HER2 Expression.

The study is being conducted to evaluate the safety, tolerability， preliminary efficacy, pharmacokinetics, and immunogenicity of SHR-A1811 combined with capecitabine in treatment of unresectable or metastatic breast cancer with low HER2 expression.


Eligibility Criteria:
Inclusion Criteria:

1. Women aged 18 to 75 (inclusive).
2. HER2 low expression unresectable or metastatic breast cancer confirmed by histology or cytology.
3. ECOG score is 0 or 1.
4. An expected survival of ≥ 12 weeks.
5. At least one measurable lesion according to RECIST v1.1 criteria.
6. Women of childbearing potential (WOCBP) subjects must agree to use highly effective contraception for 7 months from the start of study screening until the last study medication and agree not to breastfeeding.
7. Patients voluntarily joined the study and signed informed consent, had good compliance and willingness to cooperate with the visit and study related procedures.

Exclusion Criteria:

1. Have other malignancies within the past 5 years.
2. Presence with uncontrollable third space effusion.
3. Have surgical treatment, radiotherapy, chemotherapy, immunotherapy, molecular targeted therapy, biological therapy or other drug clinical studies within 4 weeks before the first medication.
4. Accepted antibody drug conjugates containing etoisomercan derivative topoisomerase I inhibitor.
5. Clinically significant cardiovascular disorders.
6. Presence of active hepatitis B, hepatitis C, cirrhosis,or serious infected persons requiring antibiotic, antiviral or antifungal control.
7. The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I.
8. Known to be allergic to any study drug or any of its excipients, or to humanized monoclonal antibody products.
9. Failure to swallow, chronic diarrhea, intestinal obstruction, or presence of other factors affecting drug administration and absorption.
10. Presence of other serious physical or mental diseases or laboratory abnormalities.
E-Health Literacy and Health Seeking Behavior in the Elderly

The purpose of this clinical trial is to determine the effect of an educational intervention on the use of digital health services for elderly individuals on e-health literacy and health seeking behavior.

The main questions it aims to answer are:

H 0 : There is no difference in terms of the total score of the e-health literacy scale.

H 0 : There is no difference in terms of the total score of the health seeking behavior scale.

The control group will continue their routine life. The researchers will conduct a 4-week intervention for the intervention group participants.

Technology Use Basic Information Training, MHRS and e-pulse Systems Usage Training Health literacy, mobile health application usage training Counseling Applications will be made at the end of the training.

Electronic health (eHealth) is the use of information and communication technology in support of health and health-related areas and is increasingly integrated into health resources and service delivery (WHO, 2019). The World Health Organization (WHO) also recognizes that digital technologies have the potential to accelerate the achievement of the Sustainable Development Goals by improving health services (WHO, 2021). However, not everyone has sufficient access or skills to use digital technology to benefit from the benefits of eHealth. This situation cannot be ignored, especially for the elderly, who are a vulnerable group (Chang et al., 2021). Elderly health and reducing health inequalities are important issues among the Sustainable Development Goals 2030 (UNDP, 2023). In order to minimize inequalities, it is very important for the individual to adapt to the innovations of the age and develop technology use skills. (Akyazı, 2018; Tuna Uysal, 2020).

The sample size was determined by Power analysis. The sample was calculated as 29 elderly individuals for each group with a power of 90%, with an effect size of 0.88 in an experimental study (Xie 2011). Considering the 10% loss probability for the study group, the sample was determined as 32 for each group (experimental and control). Before randomization, elderly individuals who meet the inclusion criteria will be given general information about the study, their informed consent will be obtained for participation in the study, and a pre-test will be administered. Then, the block randomization method will be used for randomization, and opaque envelopes will be given by an independent researcher to conceal the assignment.

At the end of the study, the training given to the experimental group will also be given to the control group.

Eligibility Criteria:
Inclusion Criteria:

At least literate Having a smart phone Elderly individuals aged 60 and over Having internet access at home or at work

Exclusion Criteria:

Illiterate Not having a smart phone Individuals under the age of 60 Not having internet access at home or at work
Clinical Trial to Compare ReJoinTM to Sodium Hyaluronate Injection for Knee Osteoarthritis Cartilage Defects

The purpose of this study is to evaluate the effectiveness of ReJoinTM for the Knee Osteoarthritis patients with Cartilage Defects comparing to Sodium Hyaluronate Injection.

This is a randomized, single-blind,phase II clinical trial.

At least 28 subjects who are with a clinical diagnosis of knee osteoarthritis cartilage defects will be randomly distributed 1:1 to the treatment group or the control group after signing the ICF and screening tests.The treatment will accept ReJoinTM at the first and fourth week,and Sodium Hyaluronate Injection at the second and third week.The control group will accept Sodium Hyaluronate Injection weekly ,and four injections in total.The duration of the therapy is 48 weeks.

In addition, external control will be added if necessary.

Eligibility Criteria:
Inclusion Criteria:

* 18-70 years old, KOA couse ≤ 10 years
* Kellgren-Lawrence Ⅰ-Ⅲ
* VAS core \>6， more than 4 months
* Signed informed consent from the subject
* cartilage defect 2-6cm2

Exclusion Criteria:

* Pregnancy test positive.
* Subject infected with hepatitis C, HIV or syphilis.
* Subject enrolled in any other cell therapy studies within the past 30 days.
* Subject deemed to be not suitable for the study by the investigator
A Study to Evaluate Satisfaction With Care in Patients With Cancer Receiving Immunotherapy Treatment at Home

The purpose of this observational study in France is to evaluate changes in satisfaction with care in participants with solid tumors who transitioned from receiving immunotherapy treatment in the hospital outpatient setting to receiving treatment at home


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 years old
* Participants whose oncology specialist has already initiated treatment with immune checkpoint inhibitors (ICIs) in the outpatient hospital setting for an advanced solid tumor (as monotherapy or in combination) or as adjuvant therapy, in an indication approved and reimbursed in France
* Participants whose oncology specialist has independently of the study defined their eligibility for hospital at home (HAH) before contacting the HAH unit for final admission
* Participants who provide oral informed consent to participate in the study

Exclusion Criteria:

* Participants who have expressed an opposition to their data collection
* Participants under guardianship
* Participants taking part in an interventional study for cancer treatment with at least one ICI as an investigational drug
Development of Domiciliary Program on Improving Activities of Daily Living Program for Patients With Stroke

The purpose of this study was to investigate the effects of the Domiciliary care- Activities of Daily Living program on activities of daily living (ADL), motor, cognition, perception, sensory, quality of life, and depression for patients with stroke.

Administering ADL and recovery of ADL functions are the primary efficacy indicators in long-term care and the main treatment goals in rehabilitation for patients with stroke. Residential rehabilitation is a direct way to observe patients' living environment and provides feasible ADL treatment plans for patients with stroke living at home or in the community. The purpose of this study was to investigate the effects of the Domiciliary care- Activities of Daily Living program on activities of daily living, motor, cognition, perception, sensory, quality of life, and depression. The eligible participants were recruited and assigned into two groups: ADL home program and control group who received traditional rehabilitation in hospital. The primary outcome measures were the Canadian Occupational Performance Measure, the Barthel Index-based Supplementary Scales, the Frenchay Activities Index, and ADL domain of the Stroke Impact Scale. The secondary outcome measures were the Fugl-Meyer Assessment, the Mini Mental State Examination, the Test of Visual Perceptual Skills-Third Edition, and the Center of Epidemiological Study-Depression.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of stroke
* Aged \> 20 years
* Score 2-4 of the modified Rankin Scale
* Capability of following instructions
* Willing to participants to the study

Exclusion Criteria:

* Diagnoses of dementia and Parkinson's disease
* Physical limitations because of orthopedics diseases
* Peripheral nerve injury
Comparison of Vasopressin and Other Pressors in Septic Shock

The purpose of this study is to compare the classical tactics in the treatment of septic shock (dopamine, noradrenalin and dobutamine) to the use of vasopressin as first choice pressor.

Vasopressin seems to be an interesting alternative in the treatment of septic shock. To this date, available studies have showed that it could correct hyperkinetic syndrome and vasoplegia in septic shocks without noticeable side effect. It as been demonstrated that vasopressin improves renal function, as no effect on digestive organs and as no metabolic effect.


Eligibility Criteria:
Inclusion Criteria:

* Legally major patient presenting a septic shock.

The time window between beginning of symptoms and onset of treatment is established at 12 hours.

The patient must be intubated and mechanically ventilated.

Patient presenting a mean arterial blood pressure of less than 60 mm Hg after adequate fluid resuscitation (at least 1 L of colloid or crystalloid) and 10 ug/Kg/min of dopamine.

Patient presenting a cardiac index of at least 3 L/min/m2

Exclusion Criteria:

* Shock other than septic
* cardiac hypokinesia
* a pre-existing organic renal failure that needs hemodyalisis
* oesophagal or gastric phatology that would lead to a naso-gastric tube contraindication
Acceptability of Social Risk Screening

Social risk screening asks patients to provide information on health-related social needs that are non-medical but affect health. These include housing stability, food security, reliable medical transportation, consistent utilities service (heat, light, water), and interpersonal safety. This research will determine the acceptability of such screening in adult patients who attend a primary care clinic in-person or via a telemedicine visit, the level of social need in patients, and how to flag such information for care, planning, and follow up.

This study will evaluate the acceptability of social risk screening among adult patients seen in the General Internal Medicine Offices (GIMO) at Montefiore Hospital. The research will enroll patients using the resident clinic, which provides medical care to lower-income patients as well as other patients. The study will be limited to new patients or patients receiving routine follow-up care.

Acceptability will be assessed by (i) the proportion of patients completing the screen among those approached; (ii) the proportion of screening questions completed; and (iii) the proportion of patients willing to complete the screening over the phone (a) by interviewer or (b) on via website using Qualtrics.

The representativeness of the sample will be assessed by comparing the participant sample to aggregate clinic demographic characteristics and deidentified Epic EHR indicators using an honest broker.

The survey instrument is the CMS Accountable Care Communities instrument. It includes patient indicators (demography) and appraisals of care (e.g., trust) that will allow assessment of correlates of social need and acceptability of screening in the clinical setting.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18+
2. New patient or routine physical exam, GIMO clinic, Montefiore Hospital

Exclusion Criteria:

1. Unable to provide verbal informed consent
2. Unable to complete questionnaire
Michigan SPARC Trial

Unhealthy alcohol use is a major contributor to morbidity and mortality in the US. Although effective prevention for unhealthy alcohol use and medication treatment for alcohol use disorders (AUDs) can be provided in primary care (PC), they have historically not been included in routine services. As a result, most patients do not receive evidence-based prevention or treatment for unhealthy alcohol use. Several efforts have successfully implemented alcohol-related preventive care-referred to as screening and brief intervention (SBI), but efforts to increase treatment of AUDs with medications have been less successful. Moreover, implementation efforts have usually neglected smaller PC practices, in which most PC is provided.

The Michigan SPARC trial is a partnership between Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle, bringing extensive expertise implementing evidence-based alcohol-related care, and Altarum Institute in Ann Arbor, Michigan, bringing demonstrated success engaging over 500 small to medium Michigan-based PC practices in effective quality improvement (QI) efforts. The project builds on Altarum's innovative approach to implementing new or improved clinical care using practice facilitators to provide continuing medical education and maintenance of certification (CME/MOC) programs to PC providers, along with ongoing support for QI using evidence-based implementation strategies. The KPWHRI team recently finished the highly successful AHRQ-funded Sustained Patient-centered Alcohol-Related Care (SPARC) trial using similar implementation strategies in KP Washington, including use of electronic health records and performance monitoring and feedback, and also developed a patient decision aid to support shared decision-making between patients with high-risk drinking and/or AUDs and their PC providers.

The Michigan SPARC trial combines Altarum's expertise in QI in small-medium PC practices in Michigan with KPWHRI's expertise implementing evidence-based prevention and treatment of unhealthy alcohol use-specifically alcohol SBI and medication treatment for AUDs.

Specific Aims of the Michigan SPARC trial had to be markedly modified due to the trial beginning in March 2020 at the same time as the COVID pandemic. A trial was not possible. The revised aims were to describe alcohol screening, brief intervention, AUD diagnosis and initiation of medication treatment for AUD, before and after the Michigan SPARC model was implemented, in small to medium PC practices in Michigan.


Eligibility Criteria:
Inclusion Criteria:

* Adults age 18 years and older
* Seen in primary care at a study practice during the practice's study period

Exclusion Criteria:

• None
Pirfenidone Use in Asbestosis Patients: Efficacy and Prognosis

This study aims at determining the the efficiency and prognosis of using pirfenidone drug among asbestosis patients.

Asbestos exposure is associated with pleural and lung fibrosis and lung cancer. It has pathomechanisms and clinical similarities to interstitial pulmonary fibrosis disease. There is no definite cure for asbestosis. Pirfenidone has antifibrotic and anti-inflammatory effects.The safety and effectiveness of pirfenidone for the treatment of non-interstitial pulmonary fibrosis progressive fibrotic interstitial lung diseases remain unclear including asbestosis. Only few studies for pirfenidone use in asbestosis.

Eligibility Criteria:
Inclusion Criteria:

* Male patients aged ≥ 18 years old
* Patients who fulfilled investigations according the study protocol.
* Patients who kept on follow up for the entire study.
* All patients fulfilling the clinical and radiological criteria of asbestosis (Existence of asbestos-specific pleural changes in high resolution computed topography HRCT (pleural plaques), Reticular changes in HRCT and restrictive lung function pattern, History of asbestos exposure, Absence of an alternative explanation for fibrotic lung disease )
* Clinically stable patients.
* Patients who signed informed consent
* Patients with mild-to-moderate IPF \[forced vita capacity (FVC) ≥50% of predicted and diffusion capacity of carbon monoxide (DLCO) ≥30% of predicted\].
* Duration since diagnosis (at least one year before the study)

Exclusion Criteria:

* Patients with peptic ulcer,
* Severe hepatic disease, hepatitis C infection or any of the following liver function test criteria above specified limits: aspartate or alanine aminotransferase (AST or ALT) \>2.5 u above upper limit of normal level.
* Severe kidney disease, Cardiac disease, and Patients with other chronic pulmonary diseases, lung cancer
* Presence of coexisting respiratory infection
* History of alcohol or drugs abuse
* Patients with neuromuscular disease,
* Chronic renal failure,
* Patient on oxygen therapy,
* Life expectancy less than 6 months,
* History of malignancy.
Tadalafil for the Treatment of Raynaud's

The investigators propose that tadalafil will increase digital blood flow and improve the symptoms and signs of secondary Raynaud's phenomenon.

The primary goal of our study is to decrease the frequency, duration and severity of vasospastic attacks in patients with secondary Raynaud's. The secondary goal is to document increased blood flow and lessened capillary dysfunction in these patients. Both of these goals are to be achieved using a course of treatment with Tadalafil.We anticipate a decrease in the frequency, duration and severity of Raynaud's attacks. Improved digital blood flow and digital blood pressures, and a decrease in digital capillary dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* active Raynaud's Phenomenon
* stable disease and medication requirements over the previous 2 months
* subjects willing and able to participate in study assessments
* ability to understand and sign informed consent
* ages 18 to 65, both sexes
* a diagnosis of diffuse or limited cutaneous sclerosis, MCTD using the American College Rheumatology criteria

Exclusion Criteria:

* uncontrolled HTN, DM, unstable disease, angina or using oral nitrates
* smoking, active alcoholism, drug abuse within 5 years
* abnormal renal function
* ulnar arterial occlusive disease as shown by a positive Allen Test
* Pregnant or breast feeding or considering preg. in next 4 months
* past or present major psych. illness
* allergy or sensitivity to tadalafil
* subject unable to understand protocol or give informed consent
* part. in another study trial within 30 days
* taking sildenafil