cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety Study of Intra-Articular Injections of Autologous Peripheral Blood Stem Cells Following Subchondral Drilling Surgery for the Treatment of Articular Cartilage Injury in the Knee

This is a 24-month, multicenter, randomized, open-label, standard treatment-controlled, parallel-group, Phase 2 study for adults with large or complicated knee articular cartilage lesions and are candidates for knee joint cartilage repair surgery. The safety and efficacy of intra-articular injections of peripheral blood stem cells (PBSCs) together with hyaluronic acid (HA) after subchondral drilling surgery will be evaluated to determine whether PBSC therapy can improve functional outcome and reduce pain of the knee joint better than a standard treatment (HA injections and physiotherapy regimen).

This is a 24-month, multicenter, randomized, open-label, standard treatment-controlled, parallel-group, Phase 2 study for adults with large or complicated knee articular cartilage lesions and are candidates for knee joint cartilage repair surgery. The safety and efficacy of intra-articular injections of peripheral blood stem cells (PBSCs) together with hyaluronic acid (HA) after subchondral drilling surgery will be evaluated to determine whether PBSC therapy can improve functional outcome and reduce pain of the knee joint better than a standard treatment (HA injections and physiotherapy regimen).

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 to 55 years at screening (20 to 57 years for the open-label extension)
* Present for evaluation and treatment of knee pain, knee swelling, or knee mechanical symptoms due to cartilage lesions
* Provide written informed consent
* International Cartilage Repair Society (ICRS) Grade 3 or 4 lesions diagnosis from MRI scans of the target knee
* All subjects must also satisfy at least 1 of the following inclusion criteria:

  * Isolated knee articular cartilage lesion (single lesion) estimated to be ≥3 cm2 as demonstrated on MRI scanning. Multiple knee articular cartilage lesions (multiple lesions) with at least 1 lesion estimated to be ≥3 cm2 as demonstrated on MRI scanning. Bipolar cartilage defects demonstrated on MRI scanning with at least 1 articular surface lesion to be ≥3 cm2. One or more cartilage defects involving the patello-femoral joint as demonstrated on MRI scanning with at least 1 lesion ≥3 cm2. One or more cartilage defects involving the tibio-femoral joint as demonstrated on MRI scanning with at least 1 lesion to be ≥3 cm2. Previously failed cartilage repair procedures (i.e., microfracture, osteochondral autograft transplantation surgery (OATS), ACI)

Exclusion Criteria:

* Three or more previous surgical interventions on the knee in question.
* Preoperative flexion deformity greater than 10 degrees.
* Presence of ligamentous injury which would require reconstruction, varus or valgus deformity requiring osteotomy, or cases that require complex surgery prior to cartilage regeneration
Thoracic Spine Manipulation on Pressure Pain Sensitivity of Active Myofascial Trigger Points in Rhomboid Muscle

This study intends to determine the effects of thoracic manipulation on pressure pain sensitivity in patients with rhomboid active trigger points.

This is a single blinded controlled trial and will be conducted at physiotherapy clinic of women institute of rehabilitation sciences Abbottabad. The "screw" manipulation is a fairly aggressive manipulative technique in which the transverse processes are forced into a posterior to anterior direction Individual will be screened out according to inclusion criteria. Individuals will be allocated randomly into two groups, 30 in thoracic manipulation group and 30 in conventional physiotherapy protocol group by sealed envelope method. Both groups will receive conventional physiotherapy protocol (manual pressure release technique and muscle imbalances exercises) for rhomboid trigger points in common and the experimental group will receive thoracic manipulation in addition to conventional protocol.

Assessment will be done on baseline and after 3 weeks. Data will be analyzed on SPSS version 21.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 to 30 years
* Participants presented with interscapular pain
* Forward head posture with active trigger points in rhomboid muscle
* Segmental hypomobility in upper thoracic identified with positive springing test

Exclusion Criteria:

* Participants who demonstrated contraindication to manipulation
* Open wounds or Trauma to the area which occurred less than two months prior treatment
* Any neurological compromise
* Mid scapular pain due to degenerative process or osteoporosis
Conservative Versus Aggressive Revascularization in Patients With Intermediate Lesions Undergoing Percutaneous Coronary Intervention With Angiography Guidance Alone

The aim of this study was to compare conservative versus aggressive strategy in patients with intermediate lesions with angiography guidance alone.

To investigate whether conservative revascularization using criteria of 70% diameter stenosis would be non-inferior to aggressive revascularization using criteria of 50% diameter stenosis in coronary intermediate lesions, we conducted the Conservative Revascularization versus Aggressive Revascularization for Coronary Stenting with Everolimus-Eluting Stents (SMART-CASE) trial.

Eligibility Criteria:
Inclusion Criteria:

* Intermediate coronary lesion(s) (diameter stenosis between 50% and 70% by quantitative coronary analysis)
* Target lesion(s) must be located in a native coronary artery with diameter of ≥2.25 mm and ≤4.25 mm

Exclusion Criteria:

* cardiogenic shock
* myocardial infarction (MI) within 48 hours
* left main lesion
* drug-eluting stent implantation in the target vessel prior to enrollment
* ≥2 chronic total occlusions in major coronary territories
* history of bleeding diathesis or known coagulopathy
* gastrointestinal or genitourinary bleeding within 3 months or major surgery within 2 months
* platelet count \<100,000 cells/mm3
* planned elective surgical procedure that would necessitate interruption of thienopyridine during the first 6 months after enrollment
* non-cardiac co-morbid conditions with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
Serious Games for Parkinson's Disease

IMPORTANCE: Rehabilitation games have been shown to improve cognitive function among people with various disorders but they have not been explored in home settings for patients with Parkinson's disease.

OBJECTIVE: To collect pilot data regarding the therapeutic benefits of self-administered rehabilitation games among patients with Parkinson's disease.

METHODS: The investigators will recruit 20 patients with Parkinson's disease into a pilot randomized controlled trial. Patients will be asked to perform two 30-minute sessions per week of training using serious games over a 3-month period in addition to conventional care or undergo only usual care. Patients will be evaluated at baseline, after 12 weeks of treatment, and at 24 weeks. Improvements in cognitive function, depression, quality of life, and mobility will be assessed.

RELEVANCE: Identifying whether self-administered rehabilitation games can lead to clinical improvements could have significant implications for the management of the disease.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of mild to moderate PD (Hoehn \& Yahr 1-3)
2. baseline MoCA score \<26
3. ≥ 18 years-old
4. ability to communicate and read in English
5. have self-reported technological literacy (ie answer yes to the question asking if they are comfortable using technological devices)

Exclusion Criteria:

1. comorbid conditions that could affect the performance of the tasks (e.g. severe uncorrected vision impairment)
2. severe cognitive impairment that would prevent the patient from understanding the tasks (MoCA\<16)
3. if the subject does not want to be video recorded during the assessments or interview sessions
4. if the subject does not have access to WiFi
Single Arm Pilot Trial of Letermovir for CMV Prophy in CAR T Cell

The goal of this clinical research study is to learn if a drug called Letermovir can help to prevent CMV reactivation.

Primary Objective:

Estimate the probabilities at days d = +28 and +98 following CAR T cell infusion, among patients alive at the day of evaluation, of CMV reactivation in CMV seropositive patients receiving letermovir for CMV prophylaxis after standard of care (SOC) axicabtagene ciloleucel (AXI-CEL) therapy, using the cutoff CMV DNA qPCR \> c for c = 400 and 1000 IU/mL to define CMV reactivation, for a total of four (d, c) combinations.

Secondary Objectives:

Estimate overall survival probabilities at days+28, +98, and +364 following CAR T cell infusion of CMV seropositive patients receiving letermovir for CMV prophylaxis after SOC AXI-CEL therapy.

Describe the tolerability of letermovir during the period of CMV prophylaxis after SOC AXI-CEL therapy in CMV seropositive patients at high risk for CMV reactivation.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years of age.
2. Have an ECOG performance status of 0 or 1.
3. The participant must be scheduled for SOC AXI-CEL.
4. The participant must be seropositive for CMV (defined as having anti-CMV IgG antibodies)
5. Creatinine clearance \> 10 mL/min
6. Child Pugh class A or B if liver disease is present.
7. Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform the treating physician immediately.
8. Participant must understand the investigational nature of this study and sign an Institutional Review Board approved written informed consent form prior to receiving any study related procedure.

Exclusion Criteria:

1. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection not responding to treatment, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
2. Female participants who are pregnant or breastfeeding.
3. Unwilling or unable to follow protocol requirements.
4. Planned to receive any other anti-CMV therapy such as high dose acyclovir (500 mg/m2/dose intravenously every 8 hours or 800 mg orally 4 times a day) or high dose valacyclovir (2 grams three to four times daily or 2 grams three times daily) for the prophylaxis of CMV reactivation. Acyclovir or valacyclovir at lower doses for the prevention of HSV and VZV are allowed.
5. Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug.
6. Evidence for CMV infection defined as any positive CMV DNA qPCR test within 1 week prior to starting letermovir.
7. Child Pugh class C liver disease.
Tranexamic Acid Versus Adrenaline for Controlling Iatrogenic Endobronchial Bleeding

Endobronchial bleeding is a relatively common complication of diagnostic bronchoscopy. Both tranexamic acid and adrenaline are used topically for the control of endobronchial bleeding. The aim of this study is to compare the efficacy of tranexamic acid with adrenaline in controlling iatrogenic endobronchial bleeding after diagnostic bronchoscopy.


Eligibility Criteria:
Inclusion Criteria:

* patients with endobronchial bleeding during diagnostic bronchoscopy that was not successfully controlled with cold (4°C) normal saline (3 aliquots of 5ml during 60sec)

Exclusion Criteria:

* Any patient with a contraindication for diagnostic flexible bronchoscopy
* Coagulopathy (PV INR \>1.3)
* Thrombocytopenia (\<50x10\^9) or anemia (hgb \<80 g/L)
* Direct oral anticoagulant, low molecular weight heparin or antiplatelet drug therapy
* Thrombophilia, history of pulmonary embolism or deep vein thrombosis
* Contraindication for endobronchial application of adrenaline
* Coronary heart disease, cerebrovascular disease, history of tachyarrhythmia
* Uncontrolled pulmonary hypertension
* Cardiovascular decompensation
* Severe hypoxia (PaO2 \<60mmHg, SaO2 \<90% with an FiO2 \>=60%)
Priorities Aligned Deprescribing for Persons Living With Dementia and Their Caregiver

The purpose of this study is to compare patient priorities care (PPC) and usual care (UC) patients to identify differences in post-encounter medication changes, treatment burden (TBQ), and shared decision making in Older Patient Assessment of Chronic Illness Care (OPACIC), to understand PPC participant's sense-making and communication approaches related to deprescribing decisions in relation to the identified health priorities and to identify and categorize adverse drug withdrawal events (ADWEs)


Eligibility Criteria:
Inclusion Criteria:

* Dementia listed as an active problem in the medical record, including Alzheimer's disease, vascular dementia, frontotemporal dementia, Parkinson's dementia, Lewy body disease.
* The functional assessment staging tool (FAST) score of 5 or lower (This will be established by the patient's clinician).
* 2 or more additional chronic conditions
* Takes 5 or more regular medications and
* A caregiver present during visits. Caregivers may include family members or unrelated caregivers and will be identified through chart review and confirmed by clinician, patient, and surrogate decision maker if necessary. Identified caregivers must be involved in decisions and care of People living with dementia (PLWD) and routinely attend clinic visits with patient

Exclusion Criteria:

* FAST score of 6 or more (This will be established by the patient's clinician).
* Significant hearing, vision, or advanced cognitive impairment that limits ability to participate in PPC encounters,
* Caregiver is unwilling or able to participate in visits, or
* Deemed ineligible by their Primary care physician (PCP)
Safety & Efficacy of Pilocarpine Ophthalmic Spray for Temporary Improvement of Near Vision in Presbyopic Adults

Volunteer participants are evaluated for eligibility during a Screening Visit; those meeting study inclusion/exclusion criteria are scheduled for 2 treatment visits. At each treatment visit, 1 of the 2 study treatments is self-administered to both eyes. Afterwards, efficacy and safety assessments are performed over a 3-hour period.


Eligibility Criteria:
Primary Inclusion Criteria:

* Poor near vision impacting daily living that requires near correction
* Best-corrected distance visual acuity (BCDVA) of 0.0 logMar or better
* Manifest refraction spherical equivalent ≥ -2.00 Diopters (D) and ≤ +2.00 D
* Monocular DCNVA between 0.4 and 0.7 logMAR, inclusive
* In need of near addition power \< +2.00 D to achieve BCNVA of 0.0 logMAR

Primary Exclusion Criteria:

* Diagnosis of glaucoma or ocular hypertension
* Narrow iridocorneal angles
* History of intraocular surgery, refractive surgery, laser treatment, or iris surgery
* Clinically significant abnormality of cornea, lens, retina, ciliary body, or iris
* Presence/history of a severe/serious ocular condition or any other unstable medical condition
* Presence or history of manifest strabismus, amblyopia, or nystagmus
* Current active eye disease for which topical or systemic ophthalmic medication is necessary, except for dry eye syndrome managed using artificial tears
* Clinically significant external ocular inflammation within 30 days of Screening Visit
* Current use or history of rigid gas permeable (RGP) contact lens use within 30 days of Screening Visit
* Known pilocarpine allergy or contraindication to use of pilocarpine
* Presence or history of congenital heart anomaly, valve disease, or other cardiac disease
* Disabling arthritis or limited motor coordination that would limit the subject's ability to self-administer study solution using the Optejet
Efficacy of Omega-3 Fatty Acids on Borderline Personality Disorder

Borderline Personality Disorder (BDP) is a serious mental disorder that affects about 1-2% of the general population, and it is characterized by severe psychosocial impairment and a high mortality rate due to suicide. Currently, the most effective treatments for BPD are psychotherapy (cognitive behavior therapy - CBT -) and pharmacotherapy (often as an important adjunctive role, especially for diminution of symptoms such as affective instability, impulsivity, psychotic-like symptoms and self-destructive behavior). Nevertheless, although several drugs are used in these patients, these drugs induce an improvement of some symptoms but do not cause the remission of BPD. Thus, identification of novel treatments is needed.

The objective of this study is to examine the efficacy of Omacor® ( a mixture of omega-3-acid ethyl esters: eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) ) for BDP patients receiving CBT. Patients with BDP will be randomly allocated to the three arms of the study: 1- CBT+placebo, 2- CBT+Omacor 1680 mg/d, 3- CBT+Omacor 3360 mg/d. Follow up will last for 12 weeks. Assessment of affective symptoms, impulsivity and aggressivity will be carried out at baseline and at 2, 4, 6, 8, 10 and 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Meet DSM-IV criteria for BPD assessed by the Structured Clinical Interview for DSM-IV Personality Disorders (SCID-II).
2. Clinical Global Impression of Severity for BDP \> 3.
3. Age between 18 and 65 years.
4. Be able to give informed consent for participation.
5. Place of residency compatible with the assistance to the center.
6. If woman, use of effective contraception.

Exclusion Criteria:

1. Have a serious medical illness.
2. History of omacor® allergy.
3. Current diagnostic unipolar depression, bipolar disorder type I, Obsessive-Compulsive Disorder, schizophrenia and other psychotic disorders.
4. DIB-R \> 8.
5. Suicidal thinking that requires hospital admission.
6. Meet DSM-IV criteria for alcohol, benzodiazepine, opioid or psychostimulant dependence in the six months prior to trial entry.
7. Transaminase elevation within three times the upper limits of normality.
8. Treatment with stable doses of antidepressants or mood stabilizers for less than six weeks.
9. Treatment with stable doses of antipsychotics for more than 1 week in the last three months.
10. Have received electroconvulsive therapy for the six months prior to trial entry.
11. Have received DBT in the last 12 months prior to trial entry.
12. Are pregnant or nursing.
13. Have participated in any other investigational study in the last 6 months prior to trial entry.
14. Current treatment or expectation to start any treatment with drugs that may interact with the study.
Infrared Ray Heat Treatment in Liver Cirrhosis Patients With Refractory Ascites

The objective of this study is to evaluate the therapeutic efficacy of Infrared ray heat treatment in hepatic area in cirrhosis patients with refractory ascites. The evaluation of the efficacy includes the ascites pressure, portal vein velocity，SAAG before and after the treatment. Clinical symptoms were also observed simultaneously.


Eligibility Criteria:
Inclusion Criteria:

* Male
* aged 18\~60 years
* inpatient
* Diagnosed with liver cirrhosis and liver stubborn ascites.

Exclusion Criteria:

* Severe problems in other vital organs(e.g.the heart,renal or lungs).
* combined with malignant tumour.
* combined with endocrine diseases.
* combined with high fever.
* infected with the AIDS virus
Sensory Attention Focused Exercise in Parkinson's Disease

The purpose of this study is 1.) to determine if sensory attention focused exercise is an effective management strategy for Parkinson's disease, and 2.) to identify if the benefits are a result of strength gains.

Currently, there is no cure for Parkinson's disease (PD) and although medication offers symptom reduction, there are many negative side effects associated with medication use. Thus, there has been an increased emphasis on exercise interventions for symptom reduction. Recent research has shown that both sensory attention focused exercise (SAFEx) and strength training interventions improved disease severity more so than other exercise interventions (such as aerobic, aquatic and no exercise). Upon closer examination, SAFEx showed further symptom improvements than the strength training program. Thus exists the need to further examine SAFEx using a standardized protocol - a single-blind randomized double-crossover trial - that has been used sparingly in exercise interventions. In addition, the 30-second chair stand has been implemented into the testing protocol, as it has been shown to be a reliable measurement of functional strength for older adults. This test was implemented in order to identify the functional strength gains, if any, that are associated with SAFEx. It is hypothesized that the SAFEx intervention will improve disease symptoms in PD, and that the results will not be due to strength gains.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of PD by a clinician/neurologist
* absence of mentation
* established medication schedule and dosage

Exclusion Criteria:

* mentation
* change in medication during period of study
* change in exercise level during period of study
* inability to complete the exercise program
* absence of 5 or more classes, or absence of 3 or more classes in sequence
Replacing Protein Via Enteral Nutrition in Critically Ill Patients

The investigator will investigate the effect of supplemental enteral protein (1.2 g/kg/day) added to standard formula to achieve high amount of enteral protein (range 2-2.4 g/kg/day) given from ICU day 5 until ICU discharge up to ICU day 90 as compared to no supplemental enteral protein to achieve moderate amount enteral protein (0.8-1.2 g/kg/day), given in conjunction with similar amounts of stepwise caloric administration in the two groups on all-cause 90-day mortality.

The REPLENISH is a multicentric, international, open label, randomized controlled trial which will enroll subjects in intensive care unit. Patients will be randomized on day 4 of ICU admission. Until ICU day 4, protein requirement will be provided according to the local practice as long as no intravenous amino acids are given and the average protein intake in the first 4 days does not exceed 0.8 g/kg/day. On ICU day 4, patients will be randomized to one of the two treatment groups: one with standard prescription without supplemental proteins (maximum1.2 g/kg/day) from the primary polymeric formula and another group will receive the standard amount of proteins (maximum 1.2 g/kg/day) from the primary polymeric formula AND supplemental protein at 1.2 g/kg/day.

Randomization will be stratified by suspected COVID-19 and then by site and the use of renal replacement therapy at the time of randomization (intermittent hemodialysis or continuous renal replacement therapy.

Eligibility Criteria:
Inclusion Criteria(on ICU calendar day 4 or the morning of day 5)

1. Age ≥18-years old
2. Patient started on enteral nutrition (EN) via nasogastric/orogastric or duodenal or percutaneous endoscopic gastrostomy (PEG) or jejunostomy tubes.
3. The patient is on invasive mechanical ventilation and unlikely to be discharged from ICU next day.

Exclusion Criteria:

1. Lack of commitment to full life support or brain death. Patients with "Do Not Resuscitate" order but with commitment to ongoing life support can be enrolled.
2. Patients on any amount of parenteral nutrition (PN) in ICU at the time of screening, whether PN is used alone or in combination with enteral nutrition. Non-nutritional calories (dextrose, propofol, citrate) not considered as PN.
3. Patients who received an average protein of more than 0.8g/kg/day in the first 4 ICU days.
4. Patients being fed entirely through oral route - i.e. those who are eating.
5. Pregnancy.
6. Burn patients.
7. Prisoners or those undergoing forced treatment.
8. Patients with hepatic encephalopathy or Child C liver cirrhosis
9. Inherited defect of amino acid metabolism.
10. Allergies to protein supplement