cyrilzakka/clinical-trials huggingface dataset:
Psychosocial Factors a Prognostic Study of Pain in Patients With CMC Osteoarthritis

In this clinical trial, females with a diagnosis of thumb CMC OA, will be recruited. The primary outcome of potential risk factors of osteoarthritis, pain and function will be measured using the demographic data, visual analog scale (VAS) and Disabilities of the Arm, Shoulder and Hand (QuickDASH). Secondary out-comes will include the Pain Self-Efficacy Questionnaire (PSEQ), Tampa Scale of Kinesiophobia (TSK), Fear Avoidance Beliefs Questionnaire (FABQ), Hospital Anxiety and Depression Scale (HADS) and Impairment and Functioning Inventory (IFI). Measurements will be taken at the baseline, three, six and 12 months follow up.

The study will start recruitment in April 2019.In this clinical trial, 50-100 females, aged 50 to 90 years of age, with a diagnosis of thumb CMC OA, will be recruited. The primary outcome of potential risk factors of osteoarthritis, pain and function will be measured using the demographic data, visual analog scale (VAS) and Disabilities of the Arm, Shoulder and Hand (QuickDASH). Secondary out-comes will include the Pain Self-Efficacy Questionnaire (PSEQ), Tampa Scale of Kinesiophobia (TSK), Fear Avoidance Beliefs Questionnaire (FABQ), Hospital Anxiety and Depression Scale (HADS) and Impairment and Functioning Inventory (IFI). Measurements will be tak-en at the baseline, three, six and 12 months follow up.

Eligibility Criteria:
Inclusion Criteria:

* women older than 18 years
* diagnosed with bilateral thumb CMC OA
* a reported pain intensity during activities of daily living (ADLs) of up to 4 of 10 on the visual analog scale (VAS)
* The referring hand surgeon will made the diagnosis of CMC OA based on radiographs and clinical exploration.

Exclusion Criteria:

* neurologic disorder affecting the upper limb
* had received previous treatment for their hand problem in the last 6 months including an intra-articular joint injection to wrist, fingers, or thumb
* had fractures or a significant hand injury or previous surgery to the wrist or hand
* had hand or finger tenosynovitis and/or Dupuytren disease
* patients who did not complete any questionnaire or if they did not sign the informed consent.
SAS-J Compared to OAGB and LSG as a Treatment for Morbid Obesity

150 morbidly obese patients divided into to equal groups, group A underwent single anastomosis sleeve jejunal bypass and group B underwent mini gastric bypass, group C underwent sleeve gastrectomy. All patients were followed for at least one year. all cases were evaluated as regard BMI, complications, nutritional status and obesity-related comorbidities.

150 morbidly obese patients divided into to equal groups, group A underwent single anastomosis sleeve jejunal bypass and group B underwent mini gastric bypass, group C underwent sleeve gastrectomy. All patients were followed for at least one year. all cases were evaluated as regard BMI, complications, nutritional status and obesity-related comorbidities. the minimal follow up period is one year

Eligibility Criteria:
Inclusion Criteria:

* obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity
* patients fit for laparoscopic surgery
* give approval to share in the study

Exclusion Criteria:

* patients refused to share in the study
* patients unfit for surgery
* patients aged less than 18 and older than 60
* patient with previous upper abdominal surgery either for obesity or other diseases
* revisional bariatric procedures
A Study to Determine the Effect of Bi-Ventricular Pacing on Cardiac Hemodynamics After Coronary Artery Bypass Graft

The purpose of this study is to determine, using echocardiography, whether bi-ventricular pacing improves the contractile force by resynchronizing both ventricles, thereby improving and/or correcting the paradoxical septal movement.

Primary Hypothesis:

* Bi-ventricular pacing post cardiac surgery will result in at least a 10% increase in cardiac index (CI) as compared with standard atrio-right ventricular pacing.

Secondary Hypothesis:

* Bi-ventricular pacing post cardiac surgery will result in at least a 10% increase in cardiac index (CI) as compared with atrio-left ventricular pacing and right atrium pacing.

Clinical trials done to date have focused on the efficacy of biventricular pacing (BVP) in the treatment of patients with congestive heart failure, Intraventricular conduction delay, dilated cardiomyopathies, and post cardiac surgery. However, studies done in post cardiac surgery patients are limited by their small sample size (4-22 patients with overall of 51 patients), non-randomized pacing protocol and by their inability to determine a definitive mechanism for the improved hemodynamics observed with BVP. Therefore, we propose to complete a pilot study aimed at determining both the magnitude of the hemodynamic benefit associated with BVP, if any. In addition, we will investigate changes in intra-ventricular septal motion as a possible mechanism for the previously observed changes in cardiac hemodynamics.

Eligibility Criteria:
Inclusion Criteria:

* All elective/emergent patients requiring isolated coronary artery bypass graft (CABG) at St. Michael's Hospital.

Exclusion Criteria:

* Patient's age \< 18 years.
* Known atrial fibrillation.
* Sinus tachycardia \> 100 beats per minute (bpm).
* Post-operative CI \< 2.
* High inotrope dosage post-operation:

  * Dopamine (Intropin) if \> 10 µg/kg/min.
  * Dobutamine (Dobutrex) if \> 10 µg/kg/min.
  * Norepinephrine (Levophed) if \> 0.1 µg/kg/min.
  * Epinephrine if \> 0.1 µg/kg/min.
* Need for intraaortic balloon pump (IABP).
* Unable or unwilling to give informed consent.
* Already participating in another clinical trial.
Efficacy and Safety of Vaccination Against Influenza H1N1 in Patients With Inflammatory Bowel Diseases (IBD) Treated Immunomodulators and Biologics

The spread of Influenza H1N1 has prompted the development of vaccines against this virus. IBD patients are at increased risk of developing complications of Influenza H1N1. The efficacy and safety of H1N1 vaccination have not been evaluated in this population of patients. We would like to estimate the efficacy and safety of vaccination against influenza H1N1 in patients with IBD who treated with immunomodulatory drugs.

200 patients with IBD and 200 healthy subjects will participate in the study. All the subjects will be vaccinated with Focetria (Novartis) and will be evaluated the day of vaccination and 4 weeks later.

The evaluation will include:

Efficacy of the vaccine: Blood will be drawn on day 0 and 4 weeks later and tested for the presence of antibodies against A/California17/2009/H1N1 by hemagglutination inhibition test.

Safety of the vaccine:

* Records of adverse event
* Assessment of disease activity : CDAI and MAYO score

Eligibility Criteria:
Inclusion Criteria:

1. Patients suffering from IBD (inflammatory bowel disease): UC/ CD
2. Able to firm an informed consent
3. Aged - 18-65
4. Candidates to receive vaccination against H1N1, according to the recommendation of the Ministry of Health
5. patients who treated with immunomodulators and biologics

Exclusion Criteria:

1. Allergy to eggs
2. Known allergy to seasonal influenza vaccine
3. Pregnant women
4. Patients who inoculate another vaccine in the past 3 weeks (except vaccine fot seasonal influenza
5. Patients without worsening in their disease condition (stable condition)
TMS and Body Image Treatment for Anorexia Nervosa

To evaluate if TMS together with a body image intervention is an efficacious treatment for anorexia nervosa compared to treatment as usual.


Eligibility Criteria:
Inclusion Criteria:

* Being enrolled as a patient at the eating disorder unit of the Child and adolescent psychiatric clinic and Psychiatric clinic in Linköping
* Having a DSM-5 diagnosis of anorexia nervosa, atypical anorexia (restrictive type)
* Being at least 18 years of age
* Having a BMI of 20 or under.
* Being free of psychotropic medications or on stable (at least three months on the same dose) medication.

Exclusion Criteria:

* Clinical diagnosis of schizophrenia or psychotic disorder
* Clinical diagnosis of bipolar disorder
* Alcohol/drug dependence
* Ongoing treatment with antipsychotics or tricyclic antidepressants
* Previous severe head injury
* Birth before 33 weeks of gestation
* Hearing impairment
* Earlier epilepsy or seizures of other causes
* Having severe claustrophobia
* Being pregnant
* Having a cognitive disability
Predictive Model for PONV for Patient Received Gynecological Laparoscopic Surgery

This is a prospective study to dynamically predict the risk of PONV in patients undergoing gynecologic laparoscopic surgery.


Eligibility Criteria:
Inclusion Criteria:

-All female patients receiving gynecological laparoscopic surgery.

Exclusion Criteria:

-Patients requiring intraoperative open-surgery, requiring other procedures in addition to gynecological laparoscopy, with severe organ dysfunction, unstable postoperative vital signs or requiring transfer to ICU.
Prospective Collection of PillCam SB3 Videos and Raw Data Files for Future Developments (SODA)

Observational, Multicenter, Post-market, Minimal risk, Prospective data collection of PillCam SB3 videos (including PillCam reports) and raw data files and optional collection of Eneteroscopy reports

Up to 8000 PillCam SB3 videos (including PillCam reports) and raw data files will be collected in up to 50 medical centers in the US. Study duration is up to 7 years from IRB approval.

Medical center study sites will provide relevant videos (including PillCam reports) and raw data from patients who underwent SB3 procedures.

Per patient demographic data will be also collected to provide a description of the study population characteristics and disposition.

Additional Standard of care data collection might be performed (optional). This data will include a de-identified Eneteroscopy report, from patients enrolled to the study and referred to Eneteroscopy procedure (all types of Eneteroscopies), following findings identified during the PillCamTM SB procedure, as part of the standard of care procedure. This data might be collected retrospectively for enrolled patients who underwent an Eneteroscopy procedure. The de-identified reports will be used by MDT GI research and development team to further develop and validated SB capsule localization.

Study subjects will not undergo any additional procedures, nor will their diagnosis and subsequent treatment pathway be changed for the purpose of the registry.

The data will be used by MDT GIs research and development team for the development and validation of improved and new detectors in the PillCam software.

The videos (including PillCam reports) and raw data files will be de-identified at the medical center by representatives who are authorized and delegated to review medical records, prior to providing them to the sponsor. All data in the study- videos, reports, raw data files and demographic information will be de-identified in a manner that is untraceable by the sponsor clinical study team members.

Eligibility Criteria:
Inclusion Criteria:

* All SB3 cases collected during standard of care procedures.
* The subject received an explanation and understands the nature of the study and provided oral consenting

Exclusion Criteria:

* None
A Study of INO-1001, an Intravenous PARP (Poly [ADP Ribose] Polymerase) Inhibitor in Acute Heart Attack Patients Undergoing Primary Percutaneous Coronary Intervention

The primary purpose of this study is to assess the safety of INO-1001 in subjects who have experienced a heart attack and are to be treated with coronary angioplasty.

Currently, heart attacks may be treated with clot-dissolving medicines, coronary angioplasty, or a combination of both. Unblocking of blood flow to the heart following coronary angioplasty can cause side effects such as heart tissue and blood vessel damage, abnormal heart rhythms and death of heart muscle cells.

In animal studies, the PARP enzyme has been shown to be involved in damaging heart muscle after the sudden unblocking of coronary arteries. INO-1001 blocks the PARP enzyme, and so it may reduce heart damage in humans who have had their coronary arteries unblocked after a heart attack.

A total of 40 patients will be selected and randomly assigned to either INO-1001 or placebo (sugar water). One dose only of the drug will be given prior to coronary angioplasty. Patients will be followed until 30 days after surgery.

The following information will be gathered: vital signs, symptoms, physical examination, blood and urine tests, electrocardiograms, and other information from medical charts.

The information provided in this listing is disclosed solely to comply with regulatory requirements. The drug INO-1001 has not yet been approved for marketing and is only available to patients who participate in a clinical trial and are chosen for the treatment group.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with acute myocardial infarction (as defined in protocol) with onset within 24 hours prior to randomization.
* Scheduled for primary percutaneous coronary intervention within 3 hours of presentation at a hospital participating in this study.
* Males and non-pregnant, non-lactating females.

Exclusion Criteria:

* Subjects will be required to undergo a full medical review in order to exclude serious medical, or psychological illness prior to inclusion.
* History of a hypersensitivity reaction to more than three drugs or mannitol.
* Participation in any investigational study within 30 days of randomization
* Treatment with certain restricted medications within a specified time prior to participation in the study.
Implementation pRogram to Improve Screening and Management for CKD in Diabetes (Program 1) (IRIS-CKD)

IRIS-CKD is an implementation study to improve guideline-recommended screening of chronic kidney disease (CKD) in individuals with type 2 diabetes (T2D) in the United States.

IRIS-CKD Screening Program: will focus on CKD screening in T2D. We will identify patients with T2D that have not received appropriate screening for CKD within the last 15 months and randomize patients to receive either a home kit to complete CKD screening ("home kit") versus a standard laboratory order ("laboratory order"). The primary objective is to evaluate whether delivery of home testing kits versus standard laboratory testing influences the degree to which patients receive guideline-recommended CKD screening. Patients will complete approximately 3 months of follow-up.

Eligibility Criteria:
Screening Program-

Inclusion Criteria:

* Adults with type 2 diabetes (T2D)
* Receiving primary care within the healthcare system, Primary Care Provider (PCP) visit within the past 24 months (any PCP provider, including APP).
* Lack of estimated glomerular filtration rate (eGFR) and/or urine albumin- creatinine ratio (UACR) measurement in the prior 15 months within the EHR

Exclusion Criteria:

• Chronic kidney disease (CKD) diagnosis
Multidimensional Recovery Patterns and Prognostic Factors After Stroke

This study aims to compare the 1-year recovery trajectories of multidimensional functional recovery among stroke survivors after discharge from hospital care.

To address this purpose, a retrospective analysis will be conducted using clinical data from two independent cohorts derived from previously published prospective observational studies. The study will conduct generalized estimating equations and mixed-effects regression models to assess differences in recovery trends among stroke subgroups.

The findings will provide detailed profiles of longitudinal changes in functional outcomes one year after discharge from hospital care. These results will clarify how stroke subtypes influence long-term functional outcomes and will guide the development of targeted interventions.

Different stroke types have unique pathophysiological mechanisms that likely affect various recovery outcomes. Understanding stroke-subtype-specific functional recovery and outcomes is crucial for effective rehabilitation and discharge planning. However, current evidence does not fully reveal how functional outcomes differ by stroke subtype, leaving gaps in our understanding of how these differences impact post-stroke recovery. Identifying the specific recovery patterns and prognostic factors associated with each stroke subtype can enhance personalized rehabilitation strategies and improve patient care.

To address this purpose, a retrospective study utilizing clinical data from two independent cohorts recruited from collaborative hospitals in Northern Taiwan between 2016 and 2018 will be implemented. The study will employ several outcome measures, including the Participation Measure-3 Domains, 4 Dimensions (PM-3D4D), the Activity Measure for Post-Acute Care (AM-PAC), the modified Rankin Scale (mRS) and other standardized assessment tools. Participants will be assessed from hospital discharge until 12-month follow-up. Data analysis will use generalized estimating equations and mixed-effects regression models to evaluate differences in recovery trends among stroke subgroups.

The findings will offer comprehensive insights into the progression of various functional outcomes of specific stroke subtypes over the course of one year following discharge. The study will also identify factors associated with long-term functional outcomes and investigate how those factors impact the trend of functional recovery. These results will demonstrate the association of stroke subtypes and long-term functional outcomes, facilitating the development of targeted interventions.

Eligibility Criteria:
Inclusion Criteria:

Stroke survivors

1. aged 20 years or older;
2. were diagnosed with a stroke confirmed by physicians;
3. were assessed at least one of the outcomes of interest, including participation (Participation Measure-3 Domains, 4 Dimensions, PM-3D4D), activity limitations (Activity Measure for Post-Acute Care short forms, AM-PAC), HRQoL (EuroQol-5D-3L, EQ-5D-3L), and cognitive impairments (Montreal Cognitive Assessment, MoCA).

Exclusion Criteria: Stroke survivors who missed all follow-up assessments.
Intravitreal Bevacizumab for Neovascular Glaucoma

Several studies have confirmed high levels of vascular endothelial growth factor (VEGF) in eyes with neovascular glaucoma (NVG). The role of VEGF inhibitors in regression of other neovascular disorders such as wet-type age-related macular degeneration and diabetic macular edema has been described. We aim to evaluate the effect of three intravitreal injections of bevacizumab (Avastin) 2.5 mg versus a sham procedure for treatment of NVG. Outcome measures include intraocular pressure and extent of iris neovascularization. Both study arms will receive conventional treatment for NVG.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of NVG
* Vision less than 20/200
* age 10-80 years

Exclusion Criteria:

* Uncontrolled Blood Pressure
* History of thromboembolism
* Congestive Heart Failure
* Renal Failure
* Pregnancy or Lactation
* Active ocular or periocular infection
* No light perception
Neurophysiology of Locomotor Adaptation and Freezing of Gait in Parkinson's Disease

Locomotor adaptation will be studied using an established split-belt treadmill paradigm, consisting of baseline (1:1 speed ratio), split-belt adaptation (2:1) and post-adaptation (1:1) walking. Split-belt walking will be performed under DBS ON and DBS OFF conditions, while off-medication.

We will test the hypotheses that DBS can facilitate split-belt walking adaptation with DBS ON compared with DBS OFF.

Eligibility Criteria:
Inclusion Criteria:

* consensus diagnosis of idiopathic PD by fellowship trained movement disorders neurologists at the Normal Fixel Institute of Neurological Diseases;
* chronically stable DBS, defined as having had DBS for at least 6 months in duration with optimized DBS settings;
* Age between 18 - 80 years old per the FDA data sheet for PD DBS;
* no dementia according to the clinical diagnostic criteria for PD dementia;
* ambulatory without the use of walking aids, or another person's assistance.

Exclusion Criteria:

* other previous neurological surgery;
* suspicion of other neurologic diagnoses such as atypical parkinsonism, or Alzheimer's disease.
Expanded Access Treatment Protocol CA204-143

The objective of this expanded access program is to provide treatment with elotuzumab in combination with lenalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma at U.S. sites where licensed physicians determine clinical need.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria

* Men and women 18 years and older.
* Active, relapsed or refractory multiple myeloma by IMWG (International myeloma Working Group) criteria as assessed by the treating physician and have received one prior line of multiple myeloma therapy.
* Prior lenalidomide exposure is permitted only if they fulfill all of the following:.

  i) Were not refractory to prior lenalidomide defined as no progression while receiving lenalidomide (induction dose) or within 60 days of last dose of lenalidomide. Patients progressing on lenalidomide maintenance dose are eligible for enrolment.

A. Patient did not discontinue lenalidomide due to a Grade ≥ 3 related AE.

Exclusion Criteria

* Active plasma cell leukemia (defined as either 20% of peripheral WBC comprised of plasma/CD138+ cells or an absolute count of 2 x 109/L).
* All Adverse Events of any prior chemotherapy, surgery, or radiotherapy not resolved to NCI CTCAE (v. 3.0) Grade ≤ 2.
* Significant cardiac disease as determined by the treating physician including cardiac amyloidosis.
* HIV infection or active hepatitis A, B, or C.
* History of participation in elotuzumab studies CA204-004, CA204-006 or CA204-009.
* Inadequate recovery from prior surgery or prior myeloma therapy. If prior allogeneic stem cell transplant, history of moderate to severe chronic graft versus host disease (GvHD).
* Any medical conditions that, in the attending physician's opinion, would impose excessive risk to the patient.
* Certain abnormal physical or laboratory findings.
* Hypersensitivity to lenalidomide, dexamethasone, any excipients in the elotuzumab formulation, or recombinant protein.
* Other protocol-defined Inclusion/Exclusion criteria apply.