cyrilzakka/clinical-trials huggingface dataset:
Effect of Physiotherapy Methods on Functional and Respiratory Outcomes in ICU Patients With Respiratory Failure

The aim of the biomedical study is to assess the changes in functional and qualitative indicators of critically ill patients with respiratory failure by applying different physiotherapy methods. By conducting this study and developing the "Physiotherapy Protocol for Critically Ill Patients Treated in the ICU," physiotherapists worldwide could be encouraged to work using a unified and adapted method.

It is expected that the results, conclusions, and practical clinical recommendations derived from this study will be beneficial not only for rehabilitation specialists and intensivists in Lithuania but also for medical professionals working with respiratory diseases, including COVID-19 patients, at various stages of their treatment and consultation.

Implementing an appropriate physiotherapy procedure protocol is anticipated to bring economic benefits, as early physiotherapy is safe and can reduce the incidence of delirium, decrease the duration of patient sedation, shorten the number of days on mechanical ventilation, and minimize hospital stay duration. Additionally, it aims to restore or improve patients' functional and independence levels, help prevent ICU-acquired weakness, and can be easily implemented in intensive care units.


Eligibility Criteria:
Inclusion Criteria:

* Adults (≥18 years of age)
* Hospitalized in the Department of Reanimation and Intensive Therapy at LSMU Kaunas Clinics
* Diagnosis of respiratory failure (KFN) based on the following TLK-10-AM codes: J96.00, J96.01, J96.9, J96.10, J96.11, J96.19, J96.90, J96.91, J96.99
* Signed informed consent obtained from the patient or their legal representative

Exclusion Criteria:

* Conscious patients who refuse to participate in the study
* Unconscious patients whose legal representative does not consent
* Recent episode of myocardial ischemia
* Pregnancy
* Heart rate \< 40 bpm or \> 130 bpm
* Mean arterial pressure \< 60 mmHg or \> 110 mmHg
* Oxygen saturation (SpO₂) ≤ 85%
* Body temperature ≥ 38.5°C or ≤ 36.0°C
A Pilot Study to Evaluate the Clinical Effectiveness and Safety of the VFIX Device as Treatment for Apical Prolapse

The primary objective of this pilot study is to evaluate the safety and effectiveness of the VFIX device in maintaining vaginal apical support for at least 6 months in women with symptomatic apical prolapse (upper vaginal or uterine prolapse).

Assuming success of the VFIX anatomical observational study (protocol 300-08-009), in this pilot study approximately 20 subjects (excluding the Device Run-In (DRI) subjects) will undergo the VFIX procedure to evaluate the safety and effectiveness of the VFIX device in maintaining apical support for at least 6 months, in women with symptomatic apical prolapse.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years
* Subjects of child bearing potential have a negative blood or urine pregnancy test prior to the procedure and subject has completed childbearing
* Subject with apical prolapse at stage II or more and requiring treatment (C should be at least -1 cm)
* On reduction of the apical prolapse, leading edge of prolapse should be at or above the hymen
* If applicable, subject has small/normal size uterus and there is no elongation of the cervix as determined by clinical assessment
* The vaginal apex can reach the Sacrospinous Ligament (SSL) on exam
* Subjects are allowed concurrent incontinence procedure as required
* Concurrent perineal repairs and excision of excess vaginal tissue repairs as required
* Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires, and documents this agreement by signing the Ethics Committee approved informed consent

Exclusion Criteria:

* Additional surgical intervention for POP repairs concurrent to the VFIX procedure (including, but not limited to sacrocolpopexy, paravaginal repair, colporrhaphy, mesh repair, etc)
* Experimental drug or experimental medical device within 3 months prior to the planned procedure
* Active genital, urinary or systemic infection at the time of the surgical procedure. Surgery may be delayed in such subjects until the infection is cleared.
* Previous hysterectomy within 6 months of scheduled surgery.
* Coagulation disorder or on therapeutic anticoagulant therapy (except aspirin) at the time of surgery
* Nursing or pregnant
* Presence of cancers of the vagina, cervix, or uterus
* In the investigator's opinion, any medical condition or psychiatric illness that could potentially be life threatening or affect their ability to complete the study visits according to this protocol
Comparison of Effects of TT With and Without Visual and Auditory Cues for Freezing & Gait Patients With PD

To determine the comparison of effects of treadmill training with and without visual and auditory cues for freezing and gait in patients with Parkinson's disease


Eligibility Criteria:
Inclusion Criteria:

* Patient who are clinically diagnosed with Parkinson Disease. Patients from both genders. Patients with age between 45 years and above. Patient with sufficient visual and auditory capacity to receive given cues will be included

Exclusion Criteria:

* Patients with the history of neurological deficit other than PD. Patients who need assistance for walking will be excluded. Patient with any peripheral vascular disease will be excluded. Patient with history of lower limb fracture.
Efficacy of Application of Myriad Matrix to Split Thickness Skin Graft Sites

To determine if application of Myriad Matrix to split thickness skin graft donor sites improves post-operative pain and appearance of the wound.

In the head and neck practice at UAB, split thickness skin grafts are a commonly used procedure for simple reconstruction. The standard dressing for donor sites is a strip of vaseline gauze which remains on the site the wound dries, and the gauze eventually falls off. Post operative pain and poor wound healing is a well established complication of the donor site, and various methods have been studied in an attempt to reduce these complications for patients in the post operative period. (1, 2, 3)

Myriad matrix is an engineered extracellular matrix (Ovine Forestomach Matrix) used for soft issue repair in complex wounds. This has been sporadically used by some of the faculty members at UAB for split thickness skin graft donor site dressings with anectodal improvement in pain and healing, though this has not yet been studied to our knowledge.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 and over who are undergoing a split thickness skin graft at UAB.

Exclusion Criteria:

* Patients who are not planned to undergo a split thickness skin graft or who are unable or do not plan to attend follow up appointments will not be included.
A Post Market Cohort With the Spinal Modulation Neurostimulator System in Peripheral Neuropathy

10-SMI-2012 is a post market observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of peripheral neuropathy


Eligibility Criteria:
Inclusion Criteria:

1. Subject is at least 18 years old
2. Subject is able and willing to comply with the follow-up schedule and protocol
3. Peripheral neuropathy for at least 6 months
4. Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain
5. Average baseline pain rating of 60 mm on the Visual Analog Scale in the primary region of pain
6. In the opinion of the Investigator, the subject is psychologically appropriate for the implantation for an active implantable medical device
7. Subject is able to provide written informed consent

Exclusion Criteria:

1. Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control
2. Escalating or changing pain condition within the past month as evidenced by investigator examination
3. Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
4. Subject has had radiofrequency treatment of an intended target dorsal root ganglion within the past 3 months
5. Subject currently has an active implantable device including implanted cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump
6. Subject is unable to operate the device
7. Subjects currently has an active infection
8. Subject has, in the opinion of the Investigator, a medical comorbidity that contraindicates placement of an active medical device
9. Subject has participated in another clinical investigation within 30 days that may confound the outcomes of the current study as determined by the investigator
Family Connections

The Family Connections study, is intended to disrupt disparities in mental health treatment access for children at-risk for childhood trauma (ACEs) and/or serious emotional disturbance (SED). "Family Connections" will use mobile clinical and family support teams to improve mental health outcomes. This clinical innovation, nested in an integrated system-of-care will be piloted for children, ages 3-18 yrs., with SED who receive primary care through Cambridge Health Alliance.


Eligibility Criteria:
Inclusion Criteria:

* 3 through 18 years (17½ years maximum at time of enrollment)
* Referred by Primary Care Physician's (PCP) from one of the three Cambridge Health Alliance (CHA) primary care intervention sites to the Family Connections team for an integrated child mental health and/or substance use disorder clinical assessment.
* Positive screen on CHA's standard pediatric mental health and substance use screening instruments, and/or parental concern about possible mental health/substance use needs, and/or PCP concern about possible mental health/substance use needs
* Enrolled in MassHealth

Exclusion Criteria:

* Subjects over 17.5 years (SAMHSA data collection required at 6 and 12 months after enrollment which must occur before age 18 years.)
* Youth who are not enrolled in MassHealth
* CHA patients with PCP located at CHA primary care site other than the identified intervention sites
Video Balance-based Exercise in Persons With Stroke

This study is to compare the effects of Interactive video balance-based exercise (IVBE) intervention and conventional rehabilitation on the balance and functional performance in stroke survivors. Fifteen participants will receive Interactive video balance-based exercise, while the other half will receive conventional rehabilitation.

Thirty individuals with stroke are recruited and allocated to 2 groups in this study. Fifteen participants in group A will undergo 30 minutes a day and 3 days a week interactive video balance-based exercise intervention for four weeks. Another 15 participants allocated to the group B will receive 30 minutes a day and 3 days a week conventional rehabilitation for four weeks. Time up go test (TUG), Berg Balance Scale (BBS), Modified Falls Efficacy Scale (MFES), Motricity Index (MI), Functional Ambulation Category (FAC) were assessed before and after intervention in both groups

Eligibility Criteria:
Inclusion Criteria:

1. patients present with unilateral hemiplegia caused by a first-ever stroke
2. cognitive ability is sufficient to understand the nature of study (Mini-Mental State Examination score\>=23)
3. medical and psychological condition stable

Exclusion Criteria:

1. patients having severe spasticity (Modified Ashworth scale \> 3)
2. severe hearing or eye problem
3. intake of drugs or other medical condition that can affect function or can't tolerate rehabilitation
The Study of Efficacy and Safety of Generic Methylphenidate Prolong-released Comparison With Original

This study is a cross-over trial, design to determine the efficacy and safety of generic and original prolong-release methylphenidate (PR-MPH) in children with ADHD who had received immediate-release methylphenidate treatment

This 4 weeks cross-over study will recruit 78 children, aged 6 to 12 years, with ADHD. They will be randomized to receive generic or original PR-MPH for 4 weeks and then switch to another brand for 4 weeks. Swanson, Nolan and Pelham parent rating scale is used to measure the primary outcome.

Eligibility Criteria:
Inclusion Criteria:

* Ages 6 to 12 years
* Diagnosis of ADHD according to DSM-5 of ICD-10
* Patient who receiving a stable dose of IR-MPH for at least 4 weeks before screening
* Patient who has a stable clinical symptoms.
* Patients or their legal representatives provide informed consent prior to enrollment

Exclusion Criteria:

* Patients who present of a serious obstructive gastrointestinal disease
* Patients cannot swallow the whole tablet
* Patients with depression, schizophrenia, bipolar disorder, and 1-month substance use prior to study
* Patients who present of an unstable co-morbidity: anxiety, seizure, conduct disorder and oppositional defiant disorder
* Patients or patients' family have a history of poor compliance
* Patients who receiving monoamine oxidase inhibitors antidepressant or stop taking not more than 14 days
* Patients who receiving PR-MPH except stop taking more than 7 days
* Patients' parent has a family problem and currently treatment with family therapy or adjust medication
Monoclonal Antibodies in Clostridium Difficile Infection

Immunoglobulin A (IgA), the major mucosal antibody, plays a key role in maintaining diversity of the intestinal microbiota and eliminating intestinal pathogens. Dysbiosis is an important risk factor for Clostridium difficile infection, which is the leading cause of nosocomial diarrhea in industrialized countries. This study aims to develop IgA monoclonal antibodies targeting C. difficile surface proteins.

Immunoglobulin A (IgA), the major mucosal antibody, plays a key role in maintaining the diversity of the intestinal microbiota and eliminating intestinal pathogens. They modulate microbiota composition and also commensal bacteria homeostasis, thus promoting a symbiotic relationship. These observations, derived from mouse studies, open promising therapeutic perspectives: IgA could be used to restore or maintain a healthy microbiota in individuals suffering from intestinal dysbiosis. Specific to a pathogen, IgA can also be considered as an alternative to antibiotics by mimicking a physiological elimination.

Abnormalities in microbial diversity (i.e. dysbiosis) have been associated in humans with various diseases such as Clostridium difficile infection, which is the leading cause of nosocomial diarrhea in industrialized countries. The incidence of CDI has dramatically raised since the early 2000s, with an increasing severity. Current treatments are limited to the administration of antibiotics that unbalance the intestinal microbiota, a risk factor for relapse. These frequent relapses contribute to the severity and chronicity of the infection.

This study aims to generate human IgA-type antibodies targeting C. difficile surface proteins with neutralizing and/or protective activity. These antibodies will be selected against surface proteins involved in the early stages of colonization. After injection or ingestion, these IgA antibodies should reproduce physiological mucosal immunity, treat severe forms and prevent the occurrence of C. difficile relapses while limiting deleterious effects on the intestinal microbiota.

C. difficile-specific B cells will be selected from infected patients. After selection of the most neutralizing IgA antibodies in vitro, these will be administered to C. difficile infected mice.

Eligibility Criteria:
Inclusion Criteria:

* adult patient, 18 years of age
* diarrhea and/or abdominal pain.
* Presence of C. difficile toxins in feces
* Patient having dated and signed informed consent.

Exclusion Criteria:

* pregnant or nursing women
* adult under guardianship
* Ileus
* Peritonitis
* Pseudomembranous colitis
* Hemodynamic instability
* Fever ≥ 38.5°C
* Shivers
* Respiratory failure
* Leukocytosis \> 15x109/L
* Serum creatinin \>50% reference values)
* Serum lactate \> 5mM
* Serum Albumine \< 30g/l
* Other diarrhea cause
* Humoral immunodeficiency
Lung Ultrasound in the Evaluation of Pneumothorax Size

Background

* Assessment of the percentage of lung collapse is crucial in the therapeutic decision-making of pneumothorax.
* The methods normally used to this purpose are radiological. Computerized tomography scan (CT) is highly accurate because it allows the exact evaluation of the volume of the air layer. However, in clinical practice assessment of the volume of pneumothorax mainly relies on the measurement of the inter-pleural distance at conventional chest radiography (CXR). This latter method is inaccurate.
* Lung ultrasound is a new method highly accurate in the first diagnosis of pneumothorax, with a sensitivity superior to CXR and similar to CT in case of traumatic pneumothorax.
* The scientific community is actually debating about the usefulness of lung ultrasound in the quantification of pneumothorax \[\]. Lung ultrasound can assess the superficial extension of the pneumothorax, but cannot evaluate its volume.

Aim

* Main purpose of the study is to compare measurement of the superficial extension of pneumothorax on the chest wall obtained by lung ultrasound, to the evaluation of the air volume performed by CT in patients with pneumothorax.
* The main hypothesis of the study is that the cut-off between small (\<11% of lung collapse) and large (\>11% of lung collapse) pneumothorax can be identified by a lung ultrasound evaluation of the superficial extension of pneumothorax.
* Second purpose of the study is to compare the accuracies of lung ultrasound and CXR in predicting the volume of pneumothorax assessed by CT.
* Secondary hypothesis is that lung ultrasound demonstrates greater accuracy in the prediction of volume of pneumothorax and percentage of lung collapse.

Methods

* Patients with a diagnosis of pneumothorax confirmed at CT are prospectively enrolled and submitted to lung ultrasound within 20 min from the CT study.
* Different locations of the sonographic "lung point" on the chest wall (i.e. the point on the chest wall where the sonographic pattern of the normally aerated lung alternates with the pathologic sonographic pattern of pneumothorax) are compared with different volumes of pneumothorax measured by CT.


Eligibility Criteria:
Inclusion Criteria:

* Radiologic diagnosis of pneumothorax
* Clinical need to perform a CT scan
* Ability to perform the lung ultrasound imaging within 20 minutes from the CT study

Exclusion Criteria:

* age less than 16 years
Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Metformin Extended Release (XR) Compared With Single Tablets

The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combinations (FDC) tablets containing empagliflozin \& metformin XR and the single tablets of empagliflozin and metformin XR when administered singularly


Eligibility Criteria:
Inclusion criteria:

1. Healthy males or females
2. Age 18-50 years (incl.)
3. Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.)
4. Subjects must be able to understand and comply with study requirements

Exclusion criteria:

Any deviation from healthy condition
A Feasibility and Safety Study of Dual Specificity CD38 and BCMA CAR-T Cell Immunotherapy for Relapsed or Refractory Multiple Myeloma

CAR-T cell therapy has shown promising results for the treatment of relapsed or refractory Multiple Myeloma,however, a subset of patients relapse due to the loss of target in tumor cells.Dual Specificity CD38 and BCMA CAR-T cells can recognize and kill the malignant cells through recognition of CD38 or BCMA. This is a phase 1/2 study designed to determine the safety of dual specificity CD38 and BCMA CAR-T cells and the feasibility of making enough to treat patients with relapsed or refractory Multiple Myeloma.

1. PRIMARY OBJECTIVES:

   1. To evaluate the feasibility and safety of dual specificity CD38 and BCMA CAR-T cells in patients with relapsed or refractory Multiple Myeloma.
   2. To evaluate the duration of in vivo persistence of adoptively transferred T cells, and the phenotype of persisting T cells.Real Time polymerase chain receptor (RT-PCR) and Flow cytometry(FCM) analysis of PB,BM and lymph node will be used to detect and quantify survival of universal dual specificity CD38 and BCMA CAR-T cells over time.
2. SECONDARY OBJECTIVES:

1.For patients with detectable disease, measure anti-tumor response due to dual specificity CD38 and BCMA CAR-T cell infusions.

2.The CAR-T cells will be administered by i.v. injection over 20-30 minutes as a using Day 0: 1-5x10e6/kg total dose on day 0.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female participant
2. 12 Years to 70 Years (Child, Adult, Senior)
3. Patient with relapsed or refractory Multiple Myeloma,multiple myeloma cell express CD38(over 50%) and BCMA (over 50%)
4. Estimated life expectancy ≥ 12 weeks (according to investigator's judgement)
5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
6. Adequate organ function

Exclusion Criteria:

1. Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease
2. Diagnosis of Burkitt's leukemia/lymphoma according to WHO classification or chronic myelogenous leukemia lymphoid blast crisis
3. Richter's syndrome
4. Presence of Grade II-IV (Glucksberg) or B-D (IBMTR) acute or extensive chronic GVHD at the time of screening
5. Subjects with any autoimmune disease or any immune deficiency disease or other disease in need of immunosuppressive therapy
6. Severe active infection (uncomplicated urinary tract infections, bacterial pharyngitis is allowed), Prophylactic antibiotic, antiviral and antifungal treatment is permissible
7. Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of screening
8. Patient has an investigational medicinal product within the last 30 days prior to screening
9. Previous treatment with investigational gene or cell therapy medicine products
10. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary
11. Pregnant or nursing women