cyrilzakka/clinical-trials huggingface dataset:
Exercise in Patients With Hypermobile Joints and Knee Pain

Pain associated with knee joint hypermobility is common in the adult population, but evidence on treatment is sparse. This study investigates if high-load resistance training is superior to usual care in improving activity-related pain in young patients (18-45 years) with hypermobile joints and knee pain.

Knee joint hypermobility is common in the adult population. Patients with knee joint hypermobility and knee pain are typically managed with low intensity resistance training and proprioceptive training to reduce knee pain and improve function, but many patients do not respond well to these treatment strategies. High-load resistance training offers additional benefits to low intensity resistance training, including marked increase in muscle cross-sectional area, neural drive, and increased tendon stiffness, all important components of acquiring active knee joint stability during movement tasks and daily life. Therefore, the primary aim of this randomised controlled trial (RCT) is to investigate if high-load resistance training is superior to usual care in reducing activity-related pain in young patients (18-45 years) with hypermobile joints and knee pain.

Eligibility Criteria:
Inclusion criteria

* Persistent knee pain for ≥ 3 months (self-reported)
* Knee pain ≥ 30mm during the last week using a 0-100 mm visual analogue scale (VAS; 0=no pain and 100=worst imaginable pain) (self-reported)
* Generalised joint hypermobility assessed with the Five-Part Hypermobility Questionnaire (positive ≥ 2/5) (self-reported)
* Local knee joint hypermobility using the passive hyperextension of the knee in standing (positive \> 10 degrees of hyperextension) and confirmed in supine lying (heel resting on 20 cm high block on the bench surface), with passive knee hyperextension (positive \> 10 degrees) (objectively measured)

Exclusion criteria

* Diagnosed with patellar tendinopathy
* Pregnancy or childbirth within the past year (due to increased levels of relaxin that could affect joint stability)
* Knee surgery within the past year
* Participation in regular structured resistance training within the past six months
* Inability to speak and understand Danish.
* All types of Ehlers-Danlos syndrome
* Other heritable connective tissue disorders such as Marfan syndrome, osteogenesis imperfecta, Loeys-Dietz syndrome, Stickler syndrome, skeletal dysplasias
* Autoimmune rheumatic connective tissue disorders such as lupus, rheumatoid arthritis; Chromosomal conditions such as Fragile X syndrome, Kabuki syndrome, Down syndrome
* Neuromuscular disorders that can cause joints to become unstable, such as multiple sclerosis
Stem Cell and Conditioned Medium for Cerebral Palsy

The aim of this study was to compare the effectiveness of umbilical cord mesenchymal stem cells (UCMSCs) and conditioned medium (CM) administration, UCMSCs only and control with standard therapy.

Hypothesis: UCMSCs + CM therapy resulting in higher improvement in cognitive function, gross motor function and chemical factors than UCMSCs and standard therapy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as Cerebral palsy with total body involvement type
* Age between 6 month - 3 years old
* Parents requesting for cell therapy
* The parents give sign in informed consent form do to examination, therapy, blood sampling collection and observation for their child

Exclusion Criteria:

* Head circumference less than -3 SD (more than 3 cm) Nellhaus standard
* Have diagnosed meningitis and encephalitis
* Have diagnosed congenital infection i.e. toxoplasmosis, rubella congenital, cytomegalovirus
* Have diagnosed metabolic disorder, chromosome disorder, congenital malformation or neuroregeneratif disease
* Progressive disorder
* Regressive development disorder
* Severe anatomical abnormalities in Brain MRI
Macrowire for IntracraNial Thrombectomy

The aim of this study is to develop a multicenter database of patient data and outcomes for patients undergoing intracranial thrombectomy for acute ischemic stroke secondary to emergent large vessel occlusion with delivery of reperfusion catheter over a novel macrowire (Aristotle Colossus) to perform intracranial mechanical thrombectomy.


Eligibility Criteria:
Inclusion Criteria:

Age \>18-85 years Time of onset \< 24 hours Acute stroke patient with NIHSS \>6 CT-ASPECTS ≥ 6 Proven intracranial occlusion - (ICA-T, M1) Modified Rankin score: 0-2

Exclusion Criteria:

Age \<18 years or \>85 years Unknown time of onset NIHSS \< 5 CT ASPECTS \<5 Pre-stroke morbidity, modified Rankin score \> 2 Tandem occlusion
Evaluate the Safety and Tolerability of INCB019602 When Administered With Metformin in Patients With Type 2 Diabetes

Determine the effect of treatment with INCB019602 administered as an add-on to stable dose metformin therapy in type 2 diabetic subjects on safety and glycemic control.


Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of T2D
* Currently taking metformin monotherapy at a stable dose level
* FPG between 150 and 270 mg/dL

Exclusion Criteria:

* History or clinical manifestations of renal impairment
* Hyperglycemia \> 270 mg/dL
* Receiving thiazolidenediones, Exenatide or sulfonylureas within 90 days prior to screening
* Prior use of Acipimox which is known under the name Olbetam within 90 days prior to screening.
* Diagnosed major depression within the last 2 years requiring hospitalization
* History of chronic insulin therapy for glycemic control
The Effects of Different Ventilator Strategies on Inflammation and Injury in Normal Lungs

This research is being done to determine if there is a way the investigators can improve the techniques that they use to assist patients with their breathing during surgery. The majority of surgeries require patients to concurrently undergo general anesthesia. This usually includes a breathing tube and a machine that breathes for the patient during the duration of the surgery. The doctors would like to investigate the effects of this type of anesthesia to healthy adult patients and whether they can improve the way they give general anesthesia to patients. The investigators plan to ask approximately 200 patients to participate. If the patients decide to participate in the study,some additions will be made to the standard anesthetic care they receive. The patients will additionally be monitored for adequate oxygenation in their blood as well as level of inflammation in their blood and lungs. The patients' breathing tube will be bathed with warm normal saline and suctioned twice during the operation. When these procedures are done the patients will be asleep and not be aware of what is happening.

The ability to provide mechanical ventilation that will not injure and may protect normal lungs during major surgical procedures of long duration may improve postoperative outcomes and decrease morbidity and mortality. The aim of the current study was to identify ventilator strategies that are less damaging to normal lungs. The investigators plan to compare three ventilation strategies commonly utilized in the operating room in normal lungs. One group will be ventilated with high tidal volume (15 mL/kg PBW) and low PEEP (3 cm H2O), another group ventilated with low tidal volume (6 mL/kg PBW) and low PEEP (3 cm H2O) and the final group ventilated with low tidal volume (6 mL/kg PBW) and high PEEP (10 cm H2O). This study will show the effects of these commonly used methods of ventilation on pulmonary mechanics, systemic and pulmonary inflammatory markers and outcomes in patients with normal lungs undergoing surgery of long duration.

Eligibility Criteria:
Inclusion Criteria:

* Elective surgery under general anesthesia expected to take 4 hours or more positioned supine for surgery

Exclusion Criteria:

* Subjects who have HIV or who have had Radiation or chemotherapy for cancer
* Subjects undergoing surgery on chest or lings
* Subjects who have obstructive sleep apnea (OSA), asthma, tuberculosis, chronic obstructive pulmonary disease
Immunogenicity of COVID-19 Vaccination in Immunocompromised Patients (Auto-COVID-VACC)

This multicenter, prospective, non-interventional study aims to evaluate data on humoral and cellular immune response generated within the COVID-19 vaccination standard in immunocompromised patients.

This study aims to analyze the immune response data generated within the procedures of the standard-of-care COVID-19 vaccination. for immunocompromised patients.

Additional blood will be drawn from the patients at each visit defined within the vaccination standard by using the same vein puncture as used for blood drawings of routine blood samples. Study related blood samples will be used for evaluation of T and B cell response to COVID-19 vaccinations.

For this study, no additional visits or invasive procedures will be performed in addition to the standard interventions.

Eligibility Criteria:
Inclusion criteria:

* Patient is vaccinated according to the recent version of the COVID-19 vaccination standard for immunocompromised patients.
* Patient is 18 years of age or older at enrollment.
* Written informed consent from patient has been obtained prior to any study related procedures

Exclusion criteria:

• Patient is not vaccinated according to the recent version of the COVID-19 vaccination standard. Patient has a positive SARS-CoV-2 antigen test at the first visit.
Exercise as Alcohol Use Disorders Intervention for Non-Treatment Seeking Adults

Alcohol use disorders are common and few individuals with the disorder ever seek help. This study proposes to intervene in a novel way - exercise, as it has many mental and physical health benefits and is an activity that is incompatible with simultaneous alcohol use. If effective, this non-stigmatizing intervention may increase the utility and acceptability of interventions for alcohol use disorders and ultimately increase the number of individuals effectively treated.

About 26 million Americans (8.5%) meet criteria for an alcohol use disorder (AUD; i.e., abuse or dependence), and most with an AUD will not ever seek help. A variety of reasons exist for not seeking help, with stigma and desire to handle the problem on one's own being primary among them. Therefore, offering interventions for AUD that do not stigmatize or require an individual to see a mental health professional may increase the utility and acceptability of AUD interventions and ultimately increase the number of individuals effectively treated. This pilot study evaluates exercise as an AUD intervention. Exercise has been proposed as a potential treatment for AUD due to its numerous mental and physical health benefits. Thirty sedentary non-treatment seeking AUD individuals to be recruited from the community via advertisements. Participants will be given a four month YMCA gym membership and will be randomized to one of two conditions: (1) assessment only (AO), or (2) a combination of two motivational enhancement therapy (MET) sessions focused on increasing exercise spaced two months apart and four months of weekly contingency management (CM) for adhering to specific exercise activities. MET is a client-centered, directive method of enhancing intrinsic motivation to change by exploring and resolving ambivalence, and CM is a behavioral treatment offering individuals tangible reinforcers such as prizes for completion of specific target behaviors. Assessments of all participants will take place at baseline, 2-months (mid-treatment), and 4-months (post-treatment. Results from this pilot study will guide future investigations of exercise as a method for intervening with non-treatment seeking AUD individuals.

Eligibility Criteria:
Inclusion Criteria:

* Age 21-55 years
* English speaking
* Sedentary
* Alcohol-related problems
* Recent heavy drinking episodes
* Blood pressure \<165/95 mmHg

Exclusion Criteria:

* Currently receiving or desiring treatment for alcohol problems
* Contraindications for exercise
* Acute psychiatric problems that require immediate treatment
* Obese - class II
* Pregnant or desire to become so in the next several months
* Other substance dependence
* In recovery for pathological gambling
Study of Efficacy and Safety of Reinfusion of Tisagenlecleucel in Pediatric and Young Adult Patients With Acute Lymphoblastic Leukemia (ALL)

This was a multi-center Phase II study investigating the efficacy and safety of reinfusion of tisagenlecleucel in pediatric and young adult patients with acute lymphoblastic leukemia (ALL) who were treated with tisagenlecleucel and experience B cell recovery.

This trial was a phase II, open label, multi-center trial to determine the efficacy and safety of tisagenlecleucel re-infusion in pediatric and adolescent young adult (AYA) patients with acute lymphoblastic leukemia (ALL) experiencing loss of B cell aplasia. Loss of B-cell aplasia is defined as: peripheral blood (PB) absolute B lymphocyte count ≥ 50/µL, OR PB B lymphocyte ≥ 10% of the total lymphocytes. B-cell aplasia is defined as PB absolute B lymphocyte count \<50/µL.

The study had the following phases for all patients: Screening, Treatment and Follow-up. The total duration of the study was about 12 months. After tisagenlecleucel re-infusion, efficacy was assessed at months 1, 3, 6, and End of Study at which time blood samples were obtained.

The study stopped early due to slow enrollment into the trial. The rate of enrollment made the trial no longer feasible to continue.

The patients were able to voluntarily withdraw from the study for any reason, at any time. Patients who received commercial tisagenlecleucel had to be followed for up to 15 years post-infusion. Patients could have been followed under the Center for International Blood and Marrow Transplant Research (CIBMTR) cellular therapy registry if consented for participation. For patients who do not provide consent for participation in the Center for International Blood and Marrow Transplant Research (CIBMTR) registry, adverse events were to be reported for 15 years or until the patient enrolls in the registry.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent must be obtained prior to participation in the study
* Must have an additional dose of unexpired, commercial tisagenlecleucel available and prescribed by a physician in the course of medical practice
* Age up to and including 25 years
* Patients must have CD-19+ Leukemia
* Patients who were previously treated with tisagenlecleucel and present with evidence of B-cell recovery as defined by: Peripheral blood (PB) absolute B lymphocyte count ≥ 50/µL, OR PB B lymphocyte ≥ 10% of the total lymphocytes

Exclusion Criteria:

* Prior gene therapy other than tisagenlecleucel
* Prior adoptive T cell therapy other than tisagenlecleucel
* Active CNS involvement by malignancy
* Active or latent hepatitis B or active hepatitis C, or any uncontrolled infection at screening
* HIV positive test within 8 weeks of screening
NC/TMD Ratio As a Difficult Airway Predictor in Obese Patients

To assess accuracy of NC/TM distance ratio in terms of sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV) for predicting difficult intubation in obese patient with Intubation difficulty score (IDS) as gold standard.

At Preanaesthesia clinic patients , neck circumference to Thyromental distance ratios of obese patients with BMI \>30Kg/m2 will be calculated and patients will be divided into two groups on the basis of Nc/TMD ratio as anticipated easy intubation ( NC/TMD\<5) And anticipated difficult intubation ( NC/TMD ≥5).

Intra-operatively, patients Intubation difficulty scale score will calculated and the data obtained from IDS score will be compared with NC/TMD ratio as a predictor of difficult Intubation and diagnostic accuracy of NC/TMD as a reliable indicator of difficult intubation in obese patients will be calculated by statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

1. ASA physical status I to III
2. Body Mass Index (BMI) of 30kg/m2 or more
3. age 18-65 years

Exclusion Criteria:

1. non consenting
2. ASA class greater than III,
3. patients undergoing general anesthesia without tracheal intubation or under regional anesthesia,
4. patients with upper airway pathology such as maxillofacial fractures, upper airway tumors or cervical spine fracture, obstetric patients, refusal of the patient, previous head and neck surgery or radiotherapy.
WIBOFA - Validation of SCT02 With ECG-App for Detection of AF

The aim of the study is to evaluate the performance of Withings SCT02 with embedded Withings ECG-app in the automatic detection of atrial fibrillation


Eligibility Criteria:
Inclusion Criteria:

* Male or female who are 22 years of age or older
* Subject able to read, understand, and provide written informed consent
* Subject willing and able to participate in the study procedures as described in the consent form
* Subject able to communicate effectively with and willing to follow instructions from the study staff

Exclusion Criteria:

* Subject with an implanted electrical device (i.e. pacemaker, ICD ...), whether active or inactive
* Pathologic disorders that may affect motricity resulting in significant hands tremor that prevents subject from being able to hold still (e.g. Parkinson disease)
* Myocardial Infarction (MI) within 90 days prior to the enrollment
* Pulmonary embolism or pulmonary infarction within 90 days prior to the enrollment
* Stroke or Transient Ischemic Attack (TIA) within 90 days prior to the enrollment
* Active or history of life-threatening rhythms as determined by investigators (e.g. ventricular tachycardia, ventricular fibrillation, 3rd degree heart block)
* Any cardiovascular disease that investigators would consider as a risk to subject or renders data uninterpretable (e.g. recent or ongoing unstable angina, decompensated heart failure, active myocarditis or pericarditis)
* Active or symptomatic skin disease on Schiller electrode attachment sites or fingertips which would be in contact with BeamO electrodes (e.g. eczema, rosacea, impetigo, dermatomyositis or allergic contact dermatitis)
* Known sensitivity to medical adhesives, isopropyl alcohol,, electrocardiogram (ECG) electrodes, including known allergy or sensitivity to stainless steel (used in BeamO electrodes).
Effect of Metal Skin Sensitivity on Restenosis After Stent Implantation

This trial is intended to find wether there is a connection between allergy to metals and reooclusion of stents in the coronary arteries


Eligibility Criteria:
Inclusion Criteria:

Patients with 2 cardiac catheterization in one years time and in the first one stent implantation

Exclusion Criteria:

None
Immunogenicity and Safety Study of NBP606 in Healthy Toddlers

This study will assess the immunogenicity and safety of booster vaccination with NBP606 compared to the existing commercial vaccine, when given concomitantly with routine pediatric vaccinations.


Eligibility Criteria:
Inclusion Criteria:

* Healthy infants who completed 3 doses of primary vaccination (NBP606_PCVI_III_2013), available for follow-ups during the study period.
* The LAR (Legally Authorized Representative) who understand the requirements of the study and voluntarily consent to participate in the study.

Exclusion Criteria:

* Administration of other vaccines, except the ones provided in this study, within 1month prior to booster study
* Known hypersensitivity to any components of the pneumococcal vaccine
* Any confirmed or suspected immunosuppressive or immunodeficient conditions
* Coagulation disorder contraindicating IM(intramuscular) vaccination
* Participation to another study
A Study to Evaluate the Safety and Immunogenicity of V710 in Adults With Kidney Disease on Hemodialysis (V710-005)(COMPLETED)

This is a study to evaluate the safety and immunogenicity of V710 with and without Merck Aluminum Adjuvant (MAA) in adult participants with end-stage kidney disease who are on hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with end stage kidney disease and is on hemodialysis
* Female patients who are able to have children must have a negative urine pregnancy tests

Exclusion Criteria:

* Developed a serious infection within the past 12 months; allergy to the components of the vaccine
* Has been vaccinated with a live virus within the past 30 days or are scheduled to be vaccinated with a live virus in the next 60 days
* Received V710 vaccine before
Interfascial Pressure Into Ultrasound Guided Anterior Quadratus Lumborum Block Application

The block has been shown to be the result of abdominal analgesia as a result of application between the quadratus lumborum (QL) muscle and the leaves in the thoracolumbar fascia.

In this block, local anesthetic drugs are administered between the quadratus lumborum (QL) muscle and the anterior leaf in the thoracolumbar fascia.

In this way, it has been reported that it provides a good analgesia as it relieves somatic pain better in upper and lower abdominal surgeries.

The mechanism of QLB analgesic contains many theories. This study includes the research relationship between the effect of fascial pressure and the success of the association block. We will use the ultrasound guided anterior Quadratus Lumborum Block. A peripheral nerve block catheter will be placed between the quadratus lumborum muscle and the psoas muscle with ultrasound.The pressure between the fascia and the pressure line added to the catheter tip will be measured.A peripheral nerve block catheter will be placed between the quadratus lumborum muscle and the psoas muscle with ultrasound. The pressure between the fascia and the pressure line added to the catheter tip will be measured.

Eligibility Criteria:
Inclusion Criteria:

Patients who were in the American Society of Anesthesiologists (ASA) I-III class

• Underwent laparoscopic cholecystectomy

Exclusion Criteria:

* Previous history of preoperative opioid use,
* Allergy to local anesthetics,
* The presence of any systemic infection,
* Uncontrolled arterial hypertension,
* Uncontrolled diabetes mellitus
* Presence of infection in the block area,
Concentration of MitoQ in Human Skeletal Muscle

The purpose of this study is to determine mitoquinone mesylate concentration levels in skeletal muscle samples obtained after intake of an acute oral dose of MitoQ.


Eligibility Criteria:
Inclusion Criteria:

* Healthy,
* Male
* 18-40 years of age

Exclusion Criteria:

* Previous use of MitoQ or CoQ-10 within 30 days of screening appointment
* Ongoing use of MitoQ
* Smoking
* Ongoing treatment with medications
* Disease deemed by the MD to infer a risk to participate in the trial