cyrilzakka/clinical-trials huggingface dataset:
Effect of BM-MSCs on Chronic AMR After Kidney Transplantation

This study is designed to investigate the efficacy and safety of allogeneic bone marrow-derived mesenchymal stem cells (BM-MSCs) on chronic antibody-mediated rejection (cAMR) after kidney transplantation. Chronic AMR is diagnosed according to Banff criteria 2013 based on renal graft biopsy and donor specific antibodies (DSA) examination. cAMR patients are assigned to MSCs group or control group. Patients in control group are prescribed to current desensitization therapy including at least one of the following treatments: plasmapheresis (PP), intravenous immunoglobulin (IVIG), rituximab or Bortezomib, depending on individual pathological and immunological features (eg. DSA type and titer) of each study subjects. Patients in MSCs group receive additional BM-MSCs therapy besides desensitization treatments as in control group. Allogeneic BM-MSCs (1\*10\^6/kg) are intravenously administered every two weeks for four consecutive doses. All cAMR patients are followed up for one year. Renal function, DSA level, pathological features, patient/graft survival, and severe adverse events are monitored during the follow-up period. Immunological features of patients in both groups are consecutively examined.


Eligibility Criteria:
Inclusion Criteria:

* kidney transplantation
* cAMR diagnosis is determined based on renal graft biopsy and DSA examination
* Patient is willing and capable of giving written informed consent for study participation and able to participate in the study for 12 months

Exclusion Criteria:

* Combined or multi-organ transplantation
* Women who are pregnant, intend to become pregnant in the next 1 years, breastfeeding, or have a positive pregnancy test on enrollment or prior to study medication administration
* Donors or recipients are known hepatitis C antibody-positive or polymerase chain reaction (PCR) positive for hepatitis C
* Donors or recipients are known hepatitis B surface antigen-positive or PCR positive for hepatitis B
* Donors or recipients are known human immunodeficiency virus (HIV) infection
* Patients with active infection
* Recipients with a history of substance abuse (drugs or alcohol) within the past 6 months, or psychotic disorders that are not capable with adequate study follow- up
* Patients with severe cardiovascular dysfunction
* WBC\<3\*10\^9/L or RBC \<5g/dL
* Highly allergic constitution or having severe history of allergies
* Patients with active peptic ulcer disease, chronic diarrhea, or gastrointestinal problem affect absorption
* Patients with a history of cancer within the last 5 years
* Prisoner or patients compulsorily detained (involuntarily incarcerated) for treatment or either a psychiatric or physical (e.g. infectious disease) illness
* Renal graft function deteriorates due to non-immunological complication, such as surgical issues or drug nephrotoxicity
The Posttraumatic Elbow Stiffness Treatment

This study compares patients with post traumatic elbow stiffness and evaluate the range of motion improvement with two types of treatment: surgical release versus non-surgical rehabilitation protocol with orthoses.

The study of the treatment of post-traumatic stiffness of the elbow presents numerous challenges. Due to the great variability of the types of lesions, causes and symptomatology, there are great difficulties in the homogenization of protocols and in the comparison of results between the different treatments. Patients with different levels of severity and time of stiffness, presence of arthrosis or not, and significant symptoms such as pain.

For patients with elbow stiffness without vicious consolidation, pseudoarthrosis, intra-articular synthesis material or heterotopic ossification, and who have already failed conventional therapy, basically have two treatment options. Which will be the subject of this study: surgical release or non-surgical rehabilitation protocols with orthoses.

In meta-analysis, evaluating the elbow range of motion gain with rehabilitation protocols associated with orthoses, the mean gain varies from 20º to 40º, depending on the type of orthosis used. On the other hand a systematic review evaluated movement gain with different surgical techniques. Observed a mean gain of 51º for open releases, but with higher complication rates. However, there are no comparative studies in the literature comparing this 2 types of treatment for post traumatic elbow stiffness: surgical release and non-surgical rehabilitation protocol with orthoses in patients who have already performed conventional physiotherapy with no success.

Eligibility Criteria:
Inclusion Criteria:

* Previous history of trauma that evolved with joint stiffness at the elbow
* Range of movement of the elbow less than 100º or extension deficit greater than 30º or flexion less than 130º
* More than six months from the initial trauma;
* Skeletal maturity;
* Have had previous physical therapy without the use of orthotics or continuous passive motion for at least 4 months;
* Absence of the following findings:
* Joint block, with range of motion equal to 0º;
* Neurological limb injury;
* Mental illness or inability to understand preoperative questionnaires;
* Active infection;
* Anterior infection at the elbow;
* Systemic autoimmune diseases. (Eg, systemic lupus erythematosus, rheumatoid arthritis, joint psoriasis, etc.).
* Absence of the following radiographic changes:
* Intra-articular synthesis material;
* Presence of vicious consolidation of the distal articular surface of the humerus and proximal ulna;
* Heterotopic ossification;
* Pseudoarthrosis of previous elbow fracture;
* Elbow incongruity;
* Grade III and IV arthrosis

Exclusion Criteria:

* Non-collaboration with rehabilitation program and postoperative follow-up;
* Need to use external fixator after surgical release due to joint instability;
* Death from non-intervention causes or loss of follow-up before the first functional evaluation (3 months).
RCT Study of Levosimendan Improving Prognosis of Cardiac Arrest

This study is intended to use a multicenter, double-blind, superior effect, placebo controlled randomized controlled clinical trial to explore the therapeutic effect of Levosimendan (within 6 hours after the recovery of spontaneous circulation) on mortality and multiple organ dysfunction such as heart and brain in patients with cardiac arrest who have recovered from active Cardiopulmonary resuscitation but have low cardiac output syndrome and coma, and the impact of 30-day mortality and neurological function after cardiac arrest.


Eligibility Criteria:
Inclusion Criteria:

* 1: Age\>18 years old

  2: After active Cardiopulmonary resuscitation, patients with cardiac arrest obtain the recovery of spontaneous circulation (ROSC), which is defined as having palpable arterial pulse lasting for more than 20 minutes

  3: Patients with witnessed cardiac arrest

  4: ROSC lasts for less than 60 minutes

  5: Low cardiac output syndrome after ROSC (LVEF\<40%)

  6: Still in a coma after ROSC, Glasgow score\<8 points

  7: Complete enrollment within 180 minutes after ROSC

Exclusion Criteria:

* 1: Patients receiving extracorporeal Cardiopulmonary resuscitation

  2: Patients with severe neurological deficits prior to cardiac arrest

  3: Patients with severe renal dysfunction (creatinine clearance rate\<30ml/min)

  4: Patients with confirmed or suspected pregnancy

  5: Patients with Intracranial hemorrhage

  6: Patients with end-stage diseases, such as advanced malignant tumors or other severe wasting diseases

  7: Patients who are unwilling to participate in the study
Behavioral Intervention Trial for HIV-infected Injection Drug Users

The purpose of this study is to test whether a ten-session behavioral intervention for HIV-infected injection drug users is effective in reducing sex and injection risk behaviors that put others at risk for HIV infection, increasing access to or utilization of HIV primary health care, and increasing adherence to HIV medications.

INSPIRE is a four-site (Baltimore, Miami, New York and San Francisco) randomized control trial to develop and evaluate the efficacy of a ten-session intervention for HIV-positive injection drug users. The primary goals of the intervention are to:

1. decrease sex and injection risk behaviors that put others at risk for HIV infection,
2. increase access to or utilization of HIV primary health care, and
3. increase adherence to HIV medications.

The intervention arm consists of 7 group sessions, 2 individual sessions, and one community experience. The control arm consists of 8 group sessions, aiming at controlling for demand (1st session) and attention (8 group sessions). Behavioral assessments and blood draws (for viral load and CD4 testing) occur at baseline, 6, and 12 month follow-up; a 3 month assessment involves behavioral assessment only. 1161 participants took baseline. Of these, 966 were randomized into the study, and 840, 807, and 821 participants took 3, 6, and 12 month follow-up assessments, respectively.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* self-identify as a person who has injected drugs in the last 12 months
* self-identify as a person who has had sex with at least one opposite sex partner within the last 3 months
* self-identify as HIV-seropositive
* be confirmed as HIV seropositive through oral fluid (saliva) HIV testing
* live in the geographic region under study,
* agree to have their blood drawn for CD4 count and viral load testing
* be willing to provide basic contact information (for follow-up)
* be able to communicate in English
* not have participated in the full-pilot of this intervention and not have enrolled previously in the present study.

Exclusion Criteria:

-
Efficacy and Safety of Different Doses of Indacaterol

This study compared the 14-day bronchodilator efficacy of indacaterol with that of placebo and salmeterol


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of asthma, and:

  1. Receiving daily treatment with inhaled corticosteroid in a regimen that has been stable for at least a month prior to screening
  2. Prebronchodilator forced expiratory volume in 1 second (FEV1) at screening ≥50 and ≤90% of predicted normal
  3. An increase of ≥12% and ≥200 mL in FEV1 over prebronchodilator value within 30 minutes after inhaling albuterol

Exclusion Criteria:

* Smoking history \>10 pack-years
* Patients with a diagnosis of chronic obstructive pulmonary disease (COPD)
* Patients with seasonal allergy whose asthma is likely to deteriorate during the study period
* Patients who have experienced a severe asthma attack/exacerbation requiring hospitalization in the 6 months prior to screening
* Patients who have had an intubation for a severe asthma exacerbation
* Patients who have had an emergency room visit for an asthma attack/asthma exacerbation within 6 weeks prior to screening
* Patients who have had a respiratory tract infection within 6 weeks prior to screening
* Patients with concomitant pulmonary disease
* Patients with diabetes Type I or uncontrolled diabetes Type II
* Any patient with lung cancer or a history of lung cancer
* Patients with a history of certain cardiovascular comorbid conditions
* Patients who have ever received or are currently receiving omalizumab or chronic oral corticosteroid therapy

Other protocol-defined inclusion/exclusion criteria may apply
fMRI of Active DBS Stimulation in Epilepsy

Researchers are trying to incorporate a process known as Functional MRI (fMRI) scanning to reveal a pattern in brain activity during Deep Brain Stimulation (DBS), which will correlate to possible seizure freedom.


Eligibility Criteria:
Inclusion Criteria

* Patients selected to undergo anterior thalamic nucleus DBS for refractory epilepsy

Exclusion Criteria

* Contraindication to MRI
E-NOSE for Breath Gas Analysis Under Microgravity Conditions

The main goal of the study is demonstrate that e-Nose system function is not altered in weightlessness and more specifically that gas concentration measurements are the same in weightlessness and normal gravity.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers (men or women)
* Aged from 20 to 65
* Affiliated to a French Social Security system or, for people living abroad, holding a European Health Insurance Card (EHIC)
* Who accepted to take part in the study
* Who has given their written stated consent
* Who has passed a medical examination similar to a standard aviation medical examination for private pilot aptitude (JAR FCL3 Class 2 medical examination). There will be no additional test performed for subject selection

Exclusion Criteria:

* Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated
* Pregnant women
Interdisciplinary Mobility Approach To Reduction Of Facility-Acquired Pressure Ulcers

Musical reminder will raise compliance with mobility in the long-term care setting and reduce facility-acquired pressure ulcers.


Eligibility Criteria:
Inclusion Criteria:

* Long-term care resident
* MDS qualified

Exclusion Criteria:

* Self pay long-term care residents
Neonatal Hypoxic Ischemic Encephalopathy : Safety and Feasibility Study of a Curative Treatment With Autologous Cord Blood Stem Cells

Neonatal hypoxic-ischaemic encephalopathy is a dramatic perinatal complication due to brain asphyxia. Neurological and neurosensory sequelae are frequent in survivors, due to neuronal damage and loss.

Currently, only total or partial body hypothermia can partially prevent cell loss. However, no treatment exists to restore neuronal functions.

Cord blood stem cells are a promising treatment for the near future.

The primary objective of this study is to test the safety and feasibility of a curative treatment with autologous cord blood stem cell in neonatal hypoxic-ischaemic encephalopathy.

The secondary objectives are to test the efficacy of this curative treatment with cell with neurogenic potential on the prevention of neurologic sequelae, as well as to test the optimum timing of cell preparation administration


Eligibility Criteria:
Inclusion Criteria:

Term ≥ 36 weeks of gestation

* and (2) :
* a blood pH \< 7 with base deficit \> 12 mmol/l (at birth or within 60 minutes of age)
* or a blood pH between 7,01 and 7,15, with additionnal criteria:
* a history of acute perinatal event (e.g : abnormal fetal cardiac rate, cord prolapse, uterine rupture, maternal hemorrhage)
* and a 5 minutes Apgar score ≤ 5, or a continued need for resuscitation, including endotracheal or mask ventilation at 5 min after birth.
* signs of encephalopathy within 12 hours of age (Sarnat and Sarnat classification, score ≥ 2)
* ± abnormal electroencephalogram or aEEG within 12 hours of age
* therapeutic hypothermia.
* no maternal infection with VIH, HTLV 1 or 2, Hepatitis B or C virus.
* maternal negative serology for syphilis
* written parental consent

Exclusion Criteria:

* presence of known chromosomal anomaly.
* presence of major congenital anomalies. severe intrauterine growth restriction (weight \<1800g)
* infants in extremis for whom no additional intensive therapy will be offered by attending neonatologist.
Sonographic Diaphragm Function in AECOPD

The study will be conducted as a single-center, prospective cohort study. The primary objective of this study is to investigate the responsiveness of sonographic parameters of diaphragm to detect change in Borg score for dyspnea during hospitalisation for AECOPD without respiratory acidosis.

To investigate the responsiveness of sonographic parameters to detect change in Borg score for dyspnea during hospitalisation for AECOPD without respiratory acidosis, we propose a prospective cohort design.

After inclusion, participants will have assessment of diaphragm function (excursion, thickness, thickening fraction) using ultrasound within 48 hours of admission to the emergency ward, striving to assessment within 24 hours of admission. Additionally, dyspnea grade will be assessed using validated questionnaires.

Further diagnostic work-up and treatment for AECOPD is performed at the discretion of the treating physician.

Both ultrasound measurements and dyspnea grade questionnaires will be repeated when the participant is reported suitable for hospital discharge by the treating physician.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalisation primarily because of severe acute exacerbation of COPD
* COPD, according to GOLD 2018 definition
* Post-bronchodilator FEV1/FVC \< 0,70 and FEV1% \< 80%pred. within last 5 years

Exclusion Criteria:

* Respiratory acidosis (pH \< 7.35 ánd PaCO2 \> 6 kPA)
* Need for (non-)invasive ventilation based on other criteria (e.g. severe hypoxia) upon presentation.
* Established diagnosis of diaphragm diaphragm paralysis.
* Inability for diaphragm imaging (e.g. mechanical ventilation, or unable to follow vocal instructions).
* Those not able or unwilling to give written informed consent.
* Pregnant women
Active MMP-8 in Oral Fluid for the Detection of Oral and Oropharyngeal Cancer

The goal of this observational study is to evaluate whether the active-matrix metalloproteinase-8 (aMMP-8) mouth-rinse test can help detect oral and oropharyngeal cancers. Researchers measured aMMP-8 levels in mouth-rinse samples collected from 77 cancer participants and 50 non-cancer participants in a clinical setting.

The main question this study seeks to answer:

Can the aMMP-8 mouth-rinse test accurately identify and differentiate cancer participants from non-cancer participants in real-time?

The goal of this prospective study is to evaluate whether the active-matrix metalloproteinase-8 (aMMP-8) mouth-rinse test can detect and differentiate 72 oral and oropharyngeal cancers from 50 control participants.

In sampling process patients were asked to pre-rinse with tap water for 30 s. After one-minute wait, they were asked to rinse their mouth 30 s with 5 mL of distilled water provided in the test kit and to spit it out in a sterile measuring cup.

The sample solution were poured into the opening of the test cassette placed on the test system (ORALyzer®) for quantitative results. After obtaining the quantitative results in 5-6 min, the cassette was promptly removed to conduct the qualitative evaluation (Periosafe®).

The expression of aMMP-8 was compared with various factors, including age, sex, smoking status, periodontitis, tumor size, nodal or distal metastases, cancer stage, histological grade, and tumor site. Statistical analysis was performed to evaluate these relationships.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy-confirmed oral or oropharyngeal cancer identified by the following International Classification of Diseases (ICD-10) codes: C00-C06, C08-C10, C13, and C32 according to the American Joint Committee on Cancer (AJCC) 8th Edition
* Adult

Exclusion Criteria:

* In-situ cancer
* Previous cancer diagnosis within five years prior to the examination
* Use of tetracyclines at the time of sampling
* Did not follow the manufacturer's instructions prior to the mouth-rinse sample (i.e. brushing teeth before sampling)
Reproductive Life Plan-based Counseling With Men

Many women and men in fertile age are at risk for sexual transmitted infections and unwanted pregnancies, and have insufficient knowledge of health promoting lifestyle prior to conception. There is a need to increase awareness among people in fertile age about how sexual risk-taking and unhealthy lifestyle can negatively affect fertility and pregnancy outcomes. Previous studies on preconception health and care have mainly focused on women. The aim of our study was to investigate if Reproductive Life Plan-based counseling with a midwife could increase men's reproductive knowledge. The second aim was to evaluate men's experiences of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Visitors at drop-in hours at two clinics testing for sexually transmitted infections

Exclusion Criteria:

* Non-Swedish speaking
* Female gender identity
Closed-loop FiO2 Controller During High Flow Oxygen Treatment In Pediatric Patients (COFICOHFOT)

Recently, high flow oxygen therapy (HFOT) is becoming more popular in the treatment of any kind of respiratory failure. Pediatric mechanical ventilation consensus conference (PEMVECC) guidelines suggest measuring oxygen saturation by pulse oximetry (SpO2) in all ventilated children and furthermore to measure partial arterial oxygen pressure (PaO2) in moderate-to-severe disease in order to prevent excessive use of oxygen while preventing hypoxemia and hyperoxemia. This study aims to compare the safety and efficacy of a closed-loop FiO2 controller (CLOC) with conventional control of FiO2 during HFOT of pediatric patients in a pediatric intensive care unit (PICU). The hypothesis of this study is: Close-loop FiO2 controller increases the time spent within clinically targeted SpO2 ranges and decreases the time spent outside clinical target SpO2 ranges as compared to manual oxygen control in PICU patients treated with HFOT.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients older than 1 month and younger than18 years of age; hospitalized at the PICU with the intention of treatment with HFOT at least for the upcoming 5 hours
* Requiring FiO2 ≥ 25% to keep SpO2 in the target ranges defined by the clinician
* Written informed consent signed and dated by the patient or one relative in case that the patient is unable to consent, after full explanation of the study by the investigator and prior to study participation

Exclusion Criteria:

* Patient with indication for immediate noninvasive ventilation (NIMV), or invasive mechanical ventilation (IMV)
* Hemodynamic instability defined as a need of continuous infusion of epinephrine or norepinephrine \> 1 mg/h
* Low quality on the SpO2 measurement using finger and ear sensor (quality index below 60% on the SpO2 sensor, which is displayed by a red or orange colour bar)
* Severe acidosis (pH ≤ 7.25)
* Pregnant woman
* Patients deemed at high risk for the need of mechanical ventilation within the next 5 hours
* Patients deemed at high risk for the need of transportation from PICU to another ward, diagnostic unit or any other hospital
* Diseases or conditions which may affect transcutaneous SpO2 measurement such as chronic or acute dyshemoglobinemia: methemoglobinemia, carbon monoxide (CO) poisoning, sickle cell disease
* Formalized ethical decision to withhold or withdraw life support
* Patient included in another interventional research study under consent
* Patient already enrolled in the present study in a previous episode of acute respiratory failure
Study on the Safety, Tolerability, and Preliminary Efficacy of 161Tb-NYM032 in Patients with Metastatic Castration-Resistant Prostate Cancer

161Tb-NYM032 is a radiopharmaceutical labeled with a PSMA ligand, used for the treatment of metastatic castration-resistant prostate cancer, which is needed for clinical trial to be conducted.


Eligibility Criteria:
\*\*1. Inclusion Criteria\*\*

1. The participant voluntarily signs the informed consent form and is able to complete the trial according to the protocol requirements.
2. Male, aged 18 years or older.
3. Diagnosed with metastatic castration-resistant prostate cancer (mCRPC) as per PCWG3 criteria.
4. Positive results on 68Ga-NYM032 positron emission tomography (PET)/computed tomography (CT) scan.
5. Must have received at least one NAAD treatment (e.g., enzalutamide and/or abiraterone) or at least one taxane-based treatment regimen, or be intolerant to or refuse taxane therapy for metastatic castration-resistant prostate cancer.
6. ECOG performance status of 0-2.
7. Expected survival of ≥6 months.
8. Laboratory parameters must meet the following:

   1. ALT and AST must not exceed 3 times the upper limit of normal (ULN); BUN and Cr must not exceed 1.5 times the ULN.
   2. Blood counts: WBC ≥3.5×10\^9/L, PLT ≥100×10\^9/L, Hb ≥90 g/L.