cyrilzakka/clinical-trials huggingface dataset:
Assessing the Japet.W+ Lumbar Traction Device in Rehabilitation for Patients With Non-specific Mechanical Low Back Pain

The study will include patients suffering from nonspecific mechanical low back pain for more than 6 weeks. Two groups will be compared. A Control group and an Experimental group with the exoskeleton JAPET.W

The study will include patients suffering from nonspecific mechanical low back pain for more than 6 weeks. The study will consist of two groups: a control group (Group CTRL) and an experimental group (Group EXP). Participants will be categorized into two categories: "workers," patients on temporary work leave due to low back pain, and "non-workers," patients unable to work due to this condition after exhausting all available therapeutic solutions.

Monitoring period (30 physiotherapy sessions): evaluations will be conducted at sessions 1, 15 and 30, on the two groups. Evaluation session 3 months after the end of the physiotherapy sessions.

Eligibility Criteria:
Inclusion Criteria:

* Nonspecific mechanical low back pain for more than 6 weeks,
* 18 years ≤ Age \< 80 years,
* Patient affiliated to the health social security system,
* Patient able to understand the information relating to the study and to sign the informed consent form

Exclusion Criteria:

* Specific low back pain (infectious, inflammatory, tumorous, or traumatic origin),
* Motor neurological deficits (peripheral or central),
* Extrapyramidal syndrome,
* Treatment with implanted neurostimulation,
* Cardiac or circulatory diseases or serious respiratory problems,
* Previous recent arthrodesis or recent lumbar prosthesis surgery,
* Surgery for herniated disc (\<3 months),
* Fracture of the dorsolumbar spine or rib (\<3 months),
* Skin lesions, contusions and stretching injuries of the trunk,
* Pregnancy,
* Individuals not tolerating the JAPET.W+ device during an initial trial,
* Under guardianship, curatorship or legal protection
GDF-15 Levels in Risk Stratification in Acute Pulmonary Embolism

Prospective observational study evaluating serum GDF-15 levels in patients with acute pulmonary embolism.

Prospective observational study evaluating serum GDF-15 levels in patients with acute pulmonary embolism (APE).

In APE right ventricle failure developing due to ischemia and myocarditis is considered the primary cause of death, however, its pathomechanism has not been fully established yet. Growth differentiation factor 15 (GDF-15) is a chemokine secreted by activated macrophages in response to oxidative stress. It has now been shown that ischemic injury, mechanical stretch, and pro-inflammatory cytokines also stimulate the expression of GDF-15 in cardiac myocytes. The objective of this project is to describe the role of GDF-15 in the pathomechanism of acute right ventricle failure in the setting of acute pulmonary embolism and to verify the hypothesis that higher serum concentrations of GDF-15 are associated with more advanced right ventricle dysfunction and failure.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with APE hospitalized who give written consent.

Exclusion Criteria:

* lack of informed consent
* APE with symptoms lasting above 14 days before the admission
* acute coronary syndrome, diagnosed pulmonary hypertension
* severe valve disease
* sepsis
* active malignancy
* diagnosed mitochondrial diseases
* chronic kidney disease at least stage 4 (KDIGO)
* pregnancy.
Diaphragmatic Myofascial Release in Gastroesophageal Reflux Disease

This study is a double blinded randomized clinical trial with two arms which aims to study the effects of diaphragmatic myofascial release in patients with gastroesophageal reflux disease (GERD).

GERD has become in the last decades a common disease at the occidental world affecting between 10 to 15% of this population. That implies a high socio-health cost and the decline of the quality of life of those patients.

The diaphragm muscle surrounds the lower esophageal sphincter, and helps to prevent gastroesophageal reflux. If one or both structures become incompetent, it may appear GERD. Until the moment, the treatment for GERD begins by lifestyle modification, and if it fails, the treatment becomes medical and, in selected cases, surgical.

It exists some studies that have demonstrate that diaphragmatic breathing training can have a positive effect in GERD and the need of drug usage. But until the moment, the effects of a myofascial release of the diaphragm haven't been explored on these patients.

Thirty patients with GERD referred from different hospitals of Valencia will be randomized into two groups:

* Intervention with myofascial release for the diaphragm
* Sham treatment group which is going to receive the same number of session treatments with the same manual techniques, but without the myofascial stimulus The protocol that will be applied consists of 4 identical sessions of myofascial release techniques aimed to normalize the myofascial tension of the diaphragmatic muscle. These sessions will be distributed in two weeks.

The study focuses on the analysis of the following variables:

* Frequency and intensity of the symptoms of GERD: Reflux Disease Questionnaire (RDQ)
* Specific quality of life for gastrointestinal disease: Gastrointestinal Quality of life Index (GIQLI)
* Drug usage: weekly milligrams usage of proton pomp inhibitors (PPI) The results of these pre-intervention and post-intervention variables will be compared between the two groups at baseline (first session), at week 3 and at week 6.


Eligibility Criteria:
Inclusion Criteria:

* Patients with the diagnostic of GERD

Exclusion Criteria:

* hiatal hernia \>2 cm
* previous operation at the LES
* actual erosive esophagitis
* Congenital or acquired immune disorders.
* Allergic status of any kind.
* Systemic diseases (rheumatic, infectious conditions, febrile state, vascular alterations, endocrine including diabetes, metabolic and neoplastic).
* Leukemia.
* Severe psychiatric disorders.
* Neuromuscular or neurological injuries.
* Aneurysms.
* Abdominal or spine surgery.
* Vertebral fractures.
* Osteoporosis (advanced stage).
* Acute lesions of soft tissues or in an inflammatory state.
* Open wounds.
* Pregnancy.
* Intrauterine device.
* Patients with corticosteroid therapy.
* Hemophilia or treatment with anticoagulant therapy.
* Hypersensitivity of the skin or dermatological diseases in the trunk that impossibilities the application of the techniques.
* Rejection of manual contact.
* Non-Spanish speaking patients.
* Patients who have previously received some treatment of myofascial release.
Multicenter Postmarket Surveillance Registry Evaluating Performance and Long Term Safety of the Presillion Stent

The purpose of this study is: To evaluate the safety and performance of the Presillion stent in routine clinical practice.

Primary endpoint: Composite of Major Adverse Cardiac Events (MACE), which includes cardiac death, myocardial infarction (Q-wave and non Q-wave) and clinically driven target lesion revascularization (TLR) at 12 months follow-up.

Data will be collected on 400 patients (from 14 hospitals in Spain and Portugal) treated with the Presillion stent in up to 2 de novo native coronary artery lesions

Study design: multicenter, prospective, observational

Eligibility Criteria:
Inclusion Criteria:

* All subjects treated with Presillion stent up to two de novo coronary artery lesions

Exclusion Criteria:

* No specified
Study on Pharmacokinetics of Single Injection of Ciprofol in Patients With Moderate to Severe Hypoproteinemia

Blood concentrations of Ciprofol were measured at different time points after single injection in patients with hypoproteinemia

This study was a single-center, interventional clinical study. Patients with different plasma albumin levels were selected before surgery and induced by a single injection of Ciprofol at a depth of 0.3 mg/kg. 2ml of venous blood was collected before and 0.5, 1, 2, 3, 5, 8, 15, 30min, 1h, 2h and 4h after administration. The pharmacokinetics of Ciprofol were studied by measuring the concentration of Ciprofol in blood.

Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate to severe hypoproteinemia (albumin \< 30g/L, protein detection time uniformly within three days before surgery）
* Weight greater than 45kg, BMI20-24
* The ASA rating is Class I or Class II

Exclusion Criteria:

* Severe liver dysfunction
* Severe renal dysfunction
* Patients with ASA grade III and above
* Known allergy to eggs, soy products, opioids and their relief drugs, propofol
* Emergency surgery
The Use of Medicinal Cannabinoids as Adjunctive Treatment for Medically Refractory Epilepsy

Many families of children with medically refractory epilepsy are choosing to use medicinal cannabinoids (MCBD) as an adjunctive alternative treatment option. The safety, tolerability and efficacy of these products are not known. The primary objective of this study is to determine how the use of MCBD affects children with medically refractory epilepsy in an observational study. Measures of evaluation to be used will include: laboratory values, developmental measures, seizure diaries and serial electroencephalographic (EEG) recordings.

This is an observational study of a family's choice to use MCBD and the effect of this substance on medically refractory epilepsy in children. The risks associated with this use are not well known. There have recently been reports of stroke, liver dysfunction and altered anticonvulsant levels. In addition, there have been long term risks reported of decreased memory function, cognitive problems and executive function abnormalities. This study does not condone or advocate the use of the substance but merely seeks to document the short term effects of the use in this population. It should be noted that providers at Children's Hospital Colorado are not registered providers for medicinal cannabis; therefore, this will be an observational study of effects of this substance as prescribed by other physicians outside of our institution.

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female \>1 month of age
2. Documentation of a diagnosis of medically refractory epilepsy as evidenced by medical records, genetic testing and/or the following clinical features:

   * Failure to control seizures despite an appropriate trial of two anticonvulsant medications at therapeutic doses
3. Baseline seizure frequency of at least 2 per week of the any of the following types:

   * Generalized tonic-clonic
   * Clonic
   * Tonic
   * Hemiconvulsive
   * Drop attacks
   * Focal motor
   * Epileptic spasms
4. 1-3 baseline anti-seizure medications at stable doses for a minimum of 4 weeks prior to enrollment.
5. Written informed consent obtained from the patient or the patient's legal representative.

Exclusion Criteria:

1. Epilepsies associated with rapidly progressing neurodegenerative diseases ex: Rasmussen encephalitis, and tumors.
2. Epilepsies associated with treatable inborn errors of metabolism
3. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
4. Non-epileptic events.
5. Current use of MCBD products (Note: Patient is eligible if currently using MCBD but will be switching to a different product).
A Study to Evaluate the Tolerance and Pharmacokinetics of TQB3602 Capsule

This is a study to evaluate the tolerance, dose-limiting toxicity (DLT), phase II recommended dose (RP2D), and maximum tolerated dose (MTD) of single and multiple oral doses of TQB3474 in patients with advanced malignant tumors.


Eligibility Criteria:
Inclusion Criteria:

* 1.Understood and signed an informed consent form. 2.18 and 75 years old , male or female. 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.

  4. Life expectancy ≥12 weeks. 5. Relapsed/refractory multiple myeloma had received at least two treatment methods.

  6. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ；No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization.

Exclusion Criteria:

* 1. Hypersensitivity to TQB3602 or its excipient. 2. Has peripheral nerve diseases ≥ grade 2. 3. Has diarrhea grade \> 1 during screening period. 4. Has received chemotherapy, radiotherapy, targeted therapy, immunotherapy, or other systemic antitumor therapies within 14 days before the first dose.

  5. Has received ixazomib and less than 5 half-life before the first dose. 6. Has received allogeneic stem cell transplant. 7. Pregnant or lactating women. 8. Has participated in other clinical trials within 4 weeks before participating in this trial.

  9. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
BIP Foley in Prevention of CAUTI at Rehab Station

This is a prospective, cross-over, randomized, controlled, partly blinded study evaluating safety and performance of noble metal alloy urinary Catheters (BIP Foley, Bactiguard AB) of both latex and silicone. The included patients are permanently catheterized spinal cord injured patients at the Spinalis clinic at Rehab station in Stockholm, Sweden.

Primary Outcome Measures:

• The primary objective is to evaluate the efficacy of long term suprapubic use of BIP Foley catheters, compared to the use of standard catheters for the same time period, on re-current symptomatic catheter associated urinary tract infection (CAUTIs).

Secondary Outcome Measures:

• to evaluate safety/performance of the catheter, i.e. antibiotic use, bacteriuria, bacteremia, urosepsis and ICU stay.

Exploratory Outcome Measures:

• assessment of levels of immunological markers in urine, urinary bacterial type and resistance pattern, catheter comfort, stability of the coating, and bacterial biofilm on the catheter surface after use.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years)
* Patients with permanent suprapubic urethral catheter (Foley catheter) of latex or silicone
* At least 3 documented CAUTI infections during last year
* Spinal Cord Injured, changing catheters at Rehab Station every 10 weeks (+/- 2 weeks)

Exclusion Criteria:

* Children (˂18 years)
* Participating in other clinical trial(s) with exposure/treatment that could affect the outcome of the present study
* Stones (calculi) in the urinary tract (these patients can be included after the stones have been removed)
* Patients on antibiotic treatment (these patients can be included after the treatment is completed (+10 days of expectance))
Recording of Physiological Data Via an Optical Sensor At the Fingertip Alongside with Double Auscultatory and Pulse Oximetry to Evaluate the Effectiveness of an Optical Blood Pressure Monitoring (OBPM)

The present study, OBPM_Calfree2024, with N = 85 participants minimum over 1 visit (lasting around 1h), has been designed to collect raw optical data with Aktiia.product-G2C Clinical investigational system together with several reference systems within a cohort of subjects characterized by a wide variety of phenotypes.


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 21 to 85yo
* Subjects fluent in written and spoken French
* Subjects agreeing to attend the study visit and follow study procedures
* Subjects that have signed the informed consent form.

Exclusion Criteria:

* Amputated index fingers
* Damaged/injured skin at index fingers
* Damaged/injured skin at wrists
* Subjects suffering from sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including tachycardia (heart rate at rest \> 120bpm) and atrial fibrillation
* Subjects suffering from pathologies that systematically reduce peripheral perfusion including Raynaud's disease, diabetes, renal dysfunctions (eGFR \< 30mL/min/1.73 m2), hyper-/hypothyroidism, pheochromocytoma or arteriovenous fistula
* Pregnant women
* Polyneuropathy
Mesenchymal Stem Cells for Treatment of Poor Graft Function After Allogeneic Hematopoietic Stem Cell Transplantation

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an effective approach for treating both benign and malignant blood disorders. It primarily involves high-dose chemotherapy to eliminate tumor cells within the patient's body, as well as to suppress the recipient's hematopoiesis and immune function. The transplantation replaces the recipient's original hematopoietic stem cells (HSCs) with donor-derived HSCs, thereby reconstructing the donor's hematopoietic and immune functions to achieve disease cure.

Poor graft function (PGF) following transplantation, which refers to inadequate engraftment of the transplanted hematopoietic stem cells, is one of the major factors limiting the effectiveness of allo-HSCT. Mesenchymal stromal cells (MSCs), identified within the bone marrow stroma, are a type of non-hematopoietic multipotent stem cells. Several studies, including previous research by our research team, suggest that MSCs can improve the bone marrow hematopoietic microenvironment by secreting various cytokines. This leads to the promotion of hematopoietic stem cell proliferation and differentiation, enhancement of hematopoietic function, and support for hematopoiesis as well as direct or indirect promotion of vascular regeneration in damaged tissues and organs.

Therefore, exploring the efficacy of umbilical cord-derived MSCs in treating poor graft function after allo-HSCT, observing the recovery of blood parameters in patients with poor engraftment, monitoring transplantation-related complications and immune reconstitution, and conducting preliminary investigations into the underlying mechanisms can contribute to the exploration of new clinical techniques for the treatment of PGF following allo-HSCT.


Eligibility Criteria:
Inclusion Criteria:

1. Screening patients for allogeneic hematopoietic stem cell transplantation;
2. No gender limit, age ≥18 years old and ≤60 years old;
3. KPS score \>60 points, expected survival period \>3 months;
4. Those without serious functional damage to important organs throughout the body;
5. The patient has no other contraindications to hematopoietic stem cell transplantation
6. Voluntary test and informed consent.

Exclusion Criteria:

1. Have severe heart, kidney or liver dysfunction;
2. Those combined with other malignant tumors need treatment;
3. There are clinical symptoms of brain dysfunction or severe mental illness and the inability to understand or follow the research protocol;
4. Patients who cannot be guaranteed to complete the necessary treatment plan and follow-up observation;
5. Patients with severe acute allergic reactions;
6. Clinically uncontrolled active infection;
7. Patients who are participating in other clinical trials;
8. Researchers believe that the subject is not suitable for clinical trials for other reasons.
The Purpose of the Study is to Continue to Provide Pemigatinib to Patients With Advanced Malignancies.

Safety and tolerability of pemigatinib.in monotherapy or combination in patients that have participated in a previous parent study to treat advanced malignancies.

A Phase 2 Open-Label, Multicenter, Rollover Study to evaluate the long term safety and tolerability of Pemigatinib and to provide Continued Treatment for Participants With Advanced Malignancies Previously Enrolled in Studies of Pemigatinib

Eligibility Criteria:
Inclusion Criteria:

* Currently enrolled and receiving treatment in an Incyte-sponsored clinical study (parent protocol) of pemigatinib as monotherapy or combination therapy.
* Currently benefiting from and tolerating treatment with pemigatinib, as determined by the investigator.
* Demonstrated compliance, as assessed by the investigator, with the parent protocol requirements.
* Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures.
* Currently have no evidence of progressive disease, as determined by the investigator, following treatment with pemigatinib as monotherapy or combination therapy.
* Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

* Able to access pemigatinib commercially or outside of a clinical trial.
* Permanently discontinued from the parent protocol for any reason.
* No longer meet the inclusion/exclusion criteria from the parent protocol if still receiving treatment.
* Women who are pregnant or breastfeeding or participants expecting to conceive or father children within the projected duration of the study.
Validation of the Ellume® Respirio Flu Test and the Ellume® eLab Flu Test for the Rapid Identification of Influenza A/B

The primary purpose of this study is to validate the sensitivity and specificity of the Respirio Flu Test and the eLab Flu Test in detecting Influenza A as compared to the gold standard for detection, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).

The secondary aims are to:

Validate the sensitivity and specificity of the Respirio Flu Test and the eLab Flu Test in detecting Influenza B as compared to the gold standard for detection, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR); Evaluate the correct interpretation of the Respirio Flu Test by subjects with influenza-like symptoms; Evaluate the subjects' satisfaction with the convenience, comfort and ease of use of the Respirio Flu Test.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged ≥ 1 year;
* Rhinorrhea;
* ≤ 5 days from onset of influenza-like illness symptoms;
* Subject (or parent/legal guardian) capable and willing to give informed consent/assent;
* Subject (or parent/legal guardian) able to read and write English.

Exclusion Criteria:

* Has undergone treatment with antivirals within the previous 7 days;
* Has been vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7 days;
* Recent craniofacial injury or surgery, including surgery to correct deviation of the nasal septum, within the previous 6 months;
* Currently enrolled in another clinical trial or used any investigational device within 90 days preceding informed consent;
* Has had prior exposure to the Respirio Flu Test or eLab Flu Test.
Evaluation of Safety & Efficacy of Synbiotic on the Incidence and Recurrence of Spontaneous Bacterial Peritonitis (SBP) in Cirrhotics

Background: Spontaneous bacterial peritonitis (SBP) is a serious complication in patients of cirrhosis with ascites and may occur despite antibiotic prophylaxis. Small bowel dysmotility and bacterial overgrowth have been documented to be related to SBP. Aims: To investigate whether addition of prebiotic plus probiotics (synbiotics) to norfloxacin enhances the efficacy of norfloxacin in prevention of SBP in high risk patients with ascites.

Methods: A prospective, double blind, randomized controlled trial was conducted in consecutive high-risk cirrhotic patients with ascites who had either recovered from an episode of SBP (secondary prophylaxis) or who never had SBP but were at high risk for development of SBP (low ascitic fluid protein or serum bilirubin ≥2.5 mg/dL; primary prophylaxis). Norfloxacin 400 mg once daily with synbiotic capsules (Streptococcus faecalis JPC 30 million, Clostridium butyricum 2 million, Bacillus mesentericus JPC 1 million, Lactobacillus sporogenes 50 million spores) 2 t.i.d. (group I) or norfloxacin 400 mg once daily with placebo (group II) was given and occurrence of SBP within a period of 6 months (primary endpoint) or side-effects of therapy and mortality (secondary endpoints) were recorded. Every patient received IV albumin to maintain a serum albumin level of \>3.2 g/dl. SBP was treated with intravenous antibiotics with albumin.


Eligibility Criteria:
Inclusion Criteria:

* Cirrhosis with ascites with any one of following:

  * History of at least one episode of SBP, or
  * Ascitic fluid protein less than or equal to 1g/dL, or
  * Serum bilirubin more than or equal to 2.5 mg/dL

Exclusion Criteria:

* Renal failure
* HCC
* Hepatic encephalopathy
* No consent