cyrilzakka/clinical-trials huggingface dataset:
Double Filtration Plasmapheresis Combined With Chemotherapy

Evaluation of double filtration plasmapheresis combined with chemotherapy for the treatment of abnormalities of M protein or renal function due to the multiple myeloma.


Eligibility Criteria:
Inclusion Criteria:

* Multiple myeloma patients who are diagnosed by bone marrow morphology and immunology
* Patients with stable condition after conventional treatment
* Patients with renal insufficiency or abnormal M protein
* Patients over 18 years of age
* Liver function: blood bilirubin ≤ 35μmol/L, enzymes aspartate transaminase (AST)/aka alanine aminotransferase (ALT) is less than 2 times the upper limit of normal
* Normal heart function
* Physical condition score 0-2 level (ECOG score)
* Obtain an informed consent form signed by the patient or family member

Exclusion Criteria:

* Allergies or obvious contraindications to any of the drugs involved in the plan
* Severe heart disease, including myocardial infarction and cardiac insufficiency.
* Suffering from other organ malignancies
* Active tuberculosis patients and HIV-positive patients
* At the same time suffering from other blood system diseases
* Pregnant or lactating women
* Able to understand or follow the research plan
* Past history of intolerance or allergy to similar drugs
* Patients under 18 years of age
* Participating in other clinical researchers at the same time
* There are any other circumstances that hinder the progress of the research
Comfortage - AD Prevention Strategies

Study is Interventional, cross-sectional, clinical trial without drug and without device


Eligibility Criteria:
Inclusion Criteria:

* subjective cognitive decline, defined as self-experienced persistent decline in cognitive capacity in comparison with a previously normal status and unrelated to an acute event; normal performance on standardised cognitive tests adjusted for age, sex, and education; decline cannot be explained by psychiatric or other neurologic disease, medical disorder, medication, or substance use; no functional impact on daily life activities
* mild cognitive decline, defined as persistent decline in cognitive performance (in comparison with a previous status) reported by the subject or by an informed caregiver; or observed by change on longitudinal cognitive testing; cognitive performance below expected range for that individual based on cognitive test performance (adjusted for age, sex, and education); performs daily life activities independently (but cognitive difficulty may result in detectable but minimal functional impact on the more complex activities of daily life, either self-reported or corroborated by a study partner); Clinical Dementia Rating Scale = 0.5
* Ability to sign and understand the informed consent form

Exclusion Criteria:

* Age under 50 or over 85 years
* Non-native Italian speakers
* Non degenerative and secondary forms of dementia
* Previous or current participation in clinical trials with anti-amyloid agents
Transcranial Direct Current Stimulation Combined With Intermittent Oral to Esophageal Tube on Dysphagia

The study is a double-blind randomized controlled trial, lasting for 15 days for each participant. Patients with post-stroke dysphagia who receive treatment at the Rehabilitation Department are selected as the study subjects. The patients are randomly assigned to either the experimental group or the placebo group. All patients receive routine rehabilitation therapy and swallowing rehabilitation training, along with enteral nutrition support using Intermittent Oro-esophageal Tube. In addition to these interventions, patients in the experimental group receive transcranial direct current stimulation, while the instruments used for patients in the placebo group only illuminate an indicator light without any actual effect.

Transcranial direct current stimulation is currently very popular. The study is a double-blind randomized controlled trial, lasting for 15 days for each participant. Patients with post-stroke dysphagia who receive treatment at the Rehabilitation Department are selected as the study subjects. The patients are randomly assigned to either the experimental group or the placebo group. All patients receive routine rehabilitation therapy and swallowing rehabilitation training, along with enteral nutrition support using Intermittent Oro-esophageal Tube. In addition to these interventions, patients in the experimental group receive transcranial direct current stimulation, while the instruments used for patients in the placebo group only illuminate an indicator light without any actual effect.

Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnostic criteria for ischemic stroke confirmed by MRI or CT;
* Age \> 18 years;
* First-time stroke;
* Swallowing disorder confirmed by swallowing contrast study or flexible endoscopic evaluation of swallowing;
* Requires enteral nutrition support;
* Stable vital signs, no severe cognitive impairment or aphasia, able to cooperate with treatment;
* Transferred to the rehabilitation department within fifteen days of onset;
* Stable vital signs.

Exclusion Criteria:

* Presence of contraindications for invasive oral endoscopy;
* Concurrent presence of other neurodegenerative diseases that may cause swallowing disorders, such as neurodegenerative diseases;
* Concurrent presence of other neurological disorders;
* Tracheostomized patients;
* Concurrent liver, kidney failure, tumor, or hematological disorders;
* Pregnancy;
* Presence of contraindications for transcranial direct current stimulation, such as epilepsy, cerebral edema;
* Recent use of centrally acting drugs that interfere with the effects of transcranial direct current stimulation, such as carbamazepine, phenytoin, valproic acid, etc.
Suberoylanilide Hydroxamic Acid in Advanced Solid Tumors

The purpose of this investigational study is to determine the safety and tolerability of oral suberoylanilide hydroxamic acid when administered in combination with standard doses of pemetrexed and cisplatin for the treatment of advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Patient must be 18 years or older with confirmed diagnosis of a solid tumor for which pemetrexed and cisplatin is acceptable treatment and have received no more than 2 prior systemic therapies
* Has at least 1 measurable lesion
* Has adequate blood, liver, and kidney functions
* Has not received any chemotherapy for at least 4 weeks prior to entry in this study
* Agrees to take adequate measures to prevent pregnancy as outlined in the protocol

Exclusion Criteria:

* Patient has been treated with other investigational agents with a similar anti-tumor mechanism
* Patient from Cohorts A and B has received pemetrexed or cisplatin within the past 6 months and from Cohorts C and D have received pemetrexed within the past 6 months
* Patient from Cohorts A and B has preexisting Grade 2 or higher neuropathy and from Cohorts C and D have Grade 3 or higher neuropathy
* Patient has active infection or had received IV (intravenous) antibiotic, antiviral, or antifungal medications within 2 weeks of the start of study drugs
* Patient has HIV, hepatitis B or hepatitis C infection
* Patient is pregnant or breast feeding
* Patient has allergy to any component of the study drugs
* Patient has history of GI (gastrointestinal) surgery or conditions
Lateral Ankle Ligament Reconstruction With InternalBrace™ Augmentation

Lateral ankle ligament stabilization procedures are well described in the orthopaedic literature. Although success rates are high, the incidence of recurrent instability is well documented. In addition, with standard rehabilitation protocols, the timeline to return to sport and functional activities may be prolonged. The InternalBrace Ligament Augmentation Repair is a safe and reproducible technique using FiberTape® and BioComposite SwiveLock® as an augmentation to a Brostrom procedure. The InternalBrace Ligament Augmentation repair consists of a FiberTape bridge between two Knotless Swivelock anchors providing a protective reinforcement and allows the surgeon to repair lateral or medial ankle instability and the pain associated with it. This type of repair can be utilized in acute and chronic ankle sprains.

It is hypothesized that use of InternalBrace Ligament Augmentation in addition to standard anatomic modified Brostrum repair allows for earlier return to pre-injury level compared to a standard Brostrum procedure. It is also secondarily hypothesized that intermediate and long term incidence of recurrent instability will be lower with use of internal brace augmentation of standard modified Brostrum lateral ankle ligament reconstruction.

Eligibility Criteria:
Inclusion criteria

* Subjects that consent to the study
* Ages 18 and older
* Subjects who are candidates for primary ankle instability reconstruction utilizing a standard Brostrum technique
* Able to understand, complete and sign/date the Informed Consent Form (ICF)

Exclusion criteria

* Subjects that are pregnant or planning to become pregnant within 58 weeks after surgery
* Persons with a mental or cognitive disability deemed significant enough that they would not be capable of completing the outcome measures
* Systemic laxity
* Bony correction (i.e. calcaneal osteotomy)
* Major additional tendon surgery such as tenodesis or repair of the peroneal tendon (synovectomy is allowable)
* Major arthroscopic surgery such as treatment of chondral defects, including microfracture (arthroscopic synovectomy and arthroscopically treated osteophyte resection are allowable)
* Revision surgery
* Inadequate tissue for standard Brostrum reconstruction
* Neuropathy
Étude de l'efficacité du Pansement Rigide Amovible Sous Vide à Titre de modalité de Pansement Post-amputation Tibiale

The present study will measure the efficiency of a new modality for trans-tibial amputations in Quebec's health system, to reduce the time before prosthesis fitting, compared to the usual modality. The present study will evaluate the feasability of implantation of this new modality in Quebec and demonstrate its superiority in comparison to the usual modality (shorter time before fitting and reduction of costs).

The main objective of the present study is to obtain an estimation of the efficiency of a Removable Rigid Dressing (RRD) -type compression modality immediately following a tibial amputation as an alternative to the elastic bandage, which is the usually-used modality. This pilot study will verify the feasability of implantation of this type of dressing, and to collect data on the main dependant variables of this research projet in order to eventually estimate the expected effect on a larger population.

The main objectives of this study are:

1. To explore the efficacy of the RRD in comparison to the elastic bandage on the size of the stump, associated complications and necessary time to fitting of the prosthesis.
2. Verify the facilitators and obstacles to implantation of the RRD as a post tibial ambutation dressing modality as an alternative to the elastic bandage.

Eligibility Criteria:
Inclusion Criteria:

* Need of a trans-tibial amputation of atraumatic cause
* Between 40 and 75 years of age

Exclusion Criteria:

- Having a medical condition that could significantly affect the healing process
Neurotrophic Factors, Tight Junction Proteins, and Cytokines in IBS

To evaluate the role of neurotrophic factors (NGF, GDNF, TRPV-1), to quantity tight junction proteins (ZO-1, occludin, claudin) and cytokines (IL-8, TNF-a, IL-1b) in the colonic mucosa of IBS patients and also clarify sex differences in the pathophysiology of IBS.


Eligibility Criteria:
Inclusion Criteria:

* Control group Those who were between 18 and 80 years old and did not have any abnormalities in colonoscopy
* Irritable bowel syndrome group Patients who diagnosed as irritable bowel syndrome according to the ROME III criteria

Exclusion Criteria:

* history of IBD
* abdominal operation
* severe systemic disease
* malignancy,
Effects of Exercise Training on Left Ventricular Function in Type 2 Diabetic Patients Post Coronary Artery Bypass Graft

The purpose of this study is to investigate the changes of cardiorespiratory fitness and left ventricular function in type 2 diabetes after uncomplicated coronary artery bypass graft (CABG) surgery.

We hypothesize that exercise capacity, left ventricular diastolic function, and biochemical data improves after 12-wk exercise training in patients with type 2 diabetes underwent CABG.

Patients with type 2 diabetes mellitus have higher incidence of coronary artery disease or left ventricular dysfunction, particularly diastolic dysfunction. Coronary artery bypass surgery is known to decrease the mortality rate in diabetes. Further exercise training can improve their cardiorespiratory fitness and the control of risk factors in these patients. However, the extent of improvement and the mechanism, especially the changes in left ventricular function, in diabetes after exercise training have not been fully explored.

Subjects will be assigned to the intervention or control group by randomization. Subjects in the intervention group will receive 60% VO2 max moderate aerobic exercise training, twice per week under supervision and three times per week at home, for 12 weeks. All subjects receive left ventricular function test by echocardiography and impedance cardiography, graded maximal exercise test, and biochemical analyses of sugar and lipid before and after 12 weeks. Their dietary intake and physical activity will be inquired every 4 weeks by questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* well-controlled diabetes
* no history of myocardial infarction
* stable post CABG for at least 3 months

Exclusion Criteria:

* heart failure
* valvular disease
* abnormal kidney or liver function
* cerebrovascular disease
* primary pulmonary disease
* other systemic or acute illness that may impede the testing or training
GI-270384 Study In Patients With Mild To Moderate Ulcerative Colitis

The aim of this double blind, placebo controlled, study is to evaluate activity consistent with efficacy provided by 14 days administration of GI270384X, and to provide preliminary pharmacokinetics and safety/tolerability of 14 days administration of GI270384X in patients with mild to moderate active ulcerative colitis (UC).


Eligibility Criteria:
Inclusion criteria:

* Females can be of childbearing or non-childbearing potential
* Subjects who have relapsing (relapsed = 6 weeks ago; this being at least a second episode) mild to moderate UC (score of 4 - 11 on the MTWI at Screening and with an endoscopy score of = 2). Diagnosis of UC originally must be established by sigmoidoscopy or colonoscopy, and have compatible histology.
* As confirmed through signed informed consent, the subject must understand and be able, willing and likely to fully comply with study procedures and restrictions

Exclusion criteria:

* Subjects with severe UC according to the MTWI (score \>11) and subjects who have been in relapse for \> 6 weeks.
* Subjects are not eligible for this study if they have Crohn's Disease, proctitis (where the extent of inflammation = 15 cm), bleeding disorders, or active ulcer disease.
* Positive stool culture for enteric pathogens (including Salmonella, Shigella, Yersinia, Aeromonas, Plesiomonas or Campylobacter).
* Presence of Clostridium difficile toxin present or with ova or parasites as detected by microscopy.
Artemether-Lumefantrine (AL) Unit Dose Pre-packs Versus Blister Packs

The purpose of this study is to determine if adherence and effectiveness of AL in the treatment of uncomplicated malaria in children aged under five years using blister packs with pictorial leaflets can be at levels comparable to those with unit dosed age specific pre-packs.

Prompt and adequate treatment of clinical malaria episodes remains one of the key elements of malaria control and this partly depends on patients' compliance to treatment. Uganda adopted Artemether-Lumefantrine (AL) as first line treatment for uncomplicated malaria. This is available at the health facilities in form of 6 dose pre-packs with different doze strengths in different packages. However, concerns about the costs and stock-outs of these packages have been raised and alternative equally efficacious alternatives need to be determined in order to reduce these problems. This study will assess if AL blister-packs can act as alternatives to the unit dose age specific pre-packs in the public sector

Eligibility Criteria:
Inclusion Criteria:

* Reported history of fever within last 48 hours and or an axillary temperature greater than or equal to 37.50C.
* Weight between 5 kg and 25 kg
* Positive malaria smear results for P. falciparum
* No history of intake of AL in the preceding two weeks
* Able to tolerate oral therapy
* Caregiver has given written informed consent to participate in the study
* If they reside within the designated catchment area of the health facility

Exclusion Criteria:

* Features of life threatening illness including severe malaria
Safety, Tolerability and Efficacy of ACTIMMUNE® Dose Escalation in Friedreich's Ataxia Study

The purpose of this phase 3 multi-center, open-label extension study is to evaluate the long-term safety of ACTIMMUNE® (interferon-γ 1b) in participants with Friedreich's Ataxia.

Participants who complete 26 weeks of blinded treatment in HZNP-ACT-301 (NCT02415127), will be eligible to enter this 6-month study. All participants will receive ACTIMMUNE® 3 times a week (TIW) for 26 weeks. In order to maintain the study blind in HZNP-ACT-301 (NCT02415127), all participants in this open-label extension study will undergo ACTIMMUNE® titration, regardless if they received ACTIMMUNE® or placebo in HZNP-ACT-301 (NCT02415127). The Week 26 Visit from HZNP-ACT-301 (NCT02415127) will serve as the Baseline Visit (Day 1) for this study. During the treatment period, additional clinic visits are scheduled at Weeks 4, 13, and 26; in between clinic visits, participants (and/or caregivers) will be monitored via emails/phone calls on a weekly basis until participants reach their maximum tolerated dose, and on a monthly basis thereafter.

Study with completed results acquired from Horizon in 2024.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent and child assent, if applicable.
* Completed 26 weeks of blinded treatment in Study HZNP-ACT-301 (NCT02415127).
* If female, the subject is not pregnant or lactating or intending to become pregnant during the study, or within 30 days after the last dose of study drug. Female subjects of child-bearing potential must have a negative urine pregnancy test result at Baseline/Day 1 (Week 26 of Study HZNP-ACT-301 \[NCT02415127\]), and agree to use a reliable method of contraception throughout the study and for 30 days after the last dose of study drug.

Exclusion Criteria:

* Subjects will be ineligible if, in the opinion of the Investigator, they are unlikely to comply with the study protocol or have a concomitant disease or condition that could interfere with the conduct of the study or potentially put the subject at unacceptable risk.

NOTE: Additional inclusion/exclusion criteria may apply.
A Study to Determine the Effect of Itraconazole on the Pharmacokinetics of Divarasib in Healthy Participants

This is a Phase 1, open-label, two-period, fixed sequence drug-drug interaction study to evaluate the impact of multiple doses of Itraconazole on the pharmacokinetics (PK) and safety of Divarasib in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Males or females of non-childbearing potential
* Within body mass index (BMI) range of 18.0 to 32.0 kg/m2, inclusive

Exclusion Criteria:

* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI), neurological, or psychiatric disorder
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator
* Poor peripheral venous access
Remote Ischemic Preconditioning in Septic Patients

Acute kidney injury is a well-recognized complication in critically ill patients. Up to date there is no clinically established method to reduce the incidence or the severity of acute kidney injury.

Remote ischemic preconditioning (RIPC) will be induced by three cycles of upper limb ischemia.

The aim of the study is to reduce the incidence of AKI by implementing remote ischemic preconditioning (identified by the urinary biomarkers tissue inhibitor of metalloproteinases-2 (TIMP-2) and insulin-like growth factor-binding protein 7(IGFBP7)

Acute kidney injury (AKI) is a common complication in critically ill patients with sepsis. To date, there is no pharmacological option to treat or prevent AKI.

Ischemic conditioning is an innate tissue adaptation elicited by ischemia that mediates local and remote organ protection against subsequent exposure to the same or other injury.

The aim of this trial is to evaluate the effects of remote ischemic conditioning in critically ill patients on acute kidney injury.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age ≥18 years)
* Critically ill patients with sepsis \< 12 hours
* Invasive ventilation for at least 24 hours (propofol-free-sedation) and/or vasopressor therapy
* Unrestricted intensive care for at least 72 hours
* Written informed consent

Exclusion Criteria:

* Pre-existing AKI
* (Glomerulo-)nephritis, interstitial nephritis, vasculitis
* Chronic kidney disease with estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73m²
* Chronic dialysis dependency
* Kidney transplant in the last 12 months
* Oral antidiabetics, sulfonamides or nicorandil
* Pregnancy or breastfeeding
* Do-not-reanimate order
* Participation in another interventional trial involving kidney outcomes within the last 3 months
* Dependency on the investigator or center