cyrilzakka/clinical-trials huggingface dataset:
Effect of Homeopathic Remedy Kalium Bichromicum on Viscosity and Amount of Sputum Mechanically Ventilated ICU Patients.

The purpose of this study is to determine whether the homeopathic remedy Kali Bichromium is effective in reducing the amount of tracheal secretions in patients intubated with a conventional endotracheal tube and receiving controlled mechanical ventilation in the ICU setting.

Profuse and tenacious tracheal secretions are a significant factor impeding the weaning process in mechanically ventilated patients in the intensive care unit (ICU). In homeopathy, high dilutions of plant extracts, minerals, and other biological substances are used as remedies for the treatment of illness, which is based on the "Law of Similars" (the higher the dilution, the stronger the effect). Kali Bichromicum (potassium dichromate) is a drug that is commonly used in homeopathy, mostly for conditions involving profuse, stringy, tenacious mucous and tracheal secretions. A recent randomized, double-blind, placebo-controlled study found a statistically significant effect of this remedy on improving the amount of tracheal secretion, timing to extubation and discharge from the ICU among critically ill patients, with no side effects observed.

The proposed study will compare the efficacy of Kali bichromicum 10-60 (C30) versus placebo in reducing the amount of tracheal secretions in patients intubated with a conventional endotracheal tube and receiving controlled mechanical ventilation in the ICU setting. Both the quantity and viscoelasticity (measured by rheometry) of the secretions will be studied, as well as sputum neutrophil count (using direct microscopy). Time to extubation and the need for re-intubation will also be evaluated. 56 patients over the age of 18 years treated with mechanical ventilation for at least 3 days will be recruited from the ICU departments of 4 medical centers in Israel. The preparations will be administered in the form of small pellet-like globules, which will be placed on the mucosa of the mouth, to the side of the endotracheal tube. Patients will be randomly allocated to either verum (n=28) or placebo (n=28) treatment, with the remedies administered twice daily with an interval of 12 hours, for a period of up to 14 days or until the patient is extubated. Any adverse event will be recorded.

Eligibility Criteria:
Inclusion Criteria:

1. any endotracheally intubated ICU patient on mechanical ventilation support for at least 3 days prior to study enrollment.
2. profuse tenacious, stringy tracheal secretions

Exclusion Criteria:

* Unstable septic patients
* Concomitant disease of the larynx and trachea obstructing the airway or inhibiting the extubation process.
* Patients with Tracheostomy
* Concomitant active heart disease.
* Need for catecholamines.
* Pregnancy.
* Patient with underlying neuromuscular disorder or any other condition preventing patient cooperation with voluntary coughing and expectoration of secretions.
* Patients with underlying conditions requiring continuous therapy with bronchorrheic medications (i.e. myasthenia gravis)
* Failure of the patient or legal guardian to give written informed consent.
Influence of Respiratory Gases Conditioning on Aerosol Delivery During Invasive Ventilation

The intention is to enroll a specific sample of intubated patients. To compare the effect of respiratory gas conditioning on lung deposition and considering the well-known influences of lung pathology on lung deposition, intubated patients with healthy lungs will be included. Postoperative neurosurgery ventilated patients respond perfectly to this criteria. A previous study including 17 postoperative neurosurgery patients was performed in 2013 with a perfect collaboration between the ICU and the Department of Neurosurgery and Anesthesiology.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Postoperative neurosurgery intubated patients admitted for brain neurosurgery in the ICU (Intensive care neuro-traumatologic and Toxicologic)- With a healthy lung function.
* Signed and dated informed consent should be obtained in accordance of local regulations.

Exclusion Criteria:

* Spine neurosurgery
* History of cardiovascular and pulmonary disease
* Extubation immediately after surgery
* Modification of the allocated humidification technique before or during the nebulization (heated-humidifier deficiency or safety concern)
* Inaccurate quantification of aerosol deposition (i.e., artifacts or overlap of tracheal and pulmonary deposition).
Effect of a Potent Inducer Rifampicin on the Pharmacokinetics of Deferasirox in Healthy Volunteers

The study will consist of two open-label periods, a Treatment Period I (deferasirox) and a Treatment Period II (rifampicin+deferasirox). At least 18 subjects are expected to complete both treatment periods as per protocol. For all subjects, in addition to the two treatment periods, there will be a 21 day screening period, one baseline evaluation (the day preceding deferasirox administration in Treatment Period I), and an end-of-study evaluation (EOS). Study subjects will be required to remain in the unit from Day -1 until Day 17. EOS evaluation (final safety assessment) will be performed 7-10 days after the last dose of rifampicin.


Eligibility Criteria:
Inclusion criteria

1. Able and willing to provide written informed consent prior to study participation
2. Male subjects from 18 - 45 years of age in good health and no evidence of iron deficiency. Subjects of reproductive potential must use barrier contraception throughout the trial.
3. Able to communicate well with the investigator and comply with the requirements of the study
4. Subjects must have a body mass index (BMI) between 18 and 33.
5. Serum ferritin value ≥20 ng/mL and transferrin saturation (Iron/TIBC) ≥15% at screening

Exclusion criteria

1. History or presence of impaired renal function
2. Abnormal serum electrolytes (e.g. sodium, potassium, chloride, or bicarbonate), magnesium and calcium
3. Evidence of urinary obstruction or difficulty in voiding at screening
4. Anemia (defined as hemoglobin \< 13 g/dL)
5. A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result at screening
6. Subjects with a known history of HIV seropositivity or history of immunocompromise
7. A past medical history of any ECG abnormalities or a family history of a prolonged QT-interval syndrome
8. Donation or loss of 400 mL blood or more within 12 weeks prior to dosing
9. Smokers (use of tobacco products in the previous 3 months). \* Other protocol-defined inclusion/exclusion criteria may apply
Compressive Cryotherapy Versus Conventional Cryotherapy After Total Knee Arthroplasty

In the postoperative period of a total knee arthroplasty, subjects present limitations of articular amplitudes, swelling, pain and functional limitations. Functional rehabilitation is unanimously recommended, including the use of cryotherapy. However, there is no consensus regarding the methods of application of cryotherapy. Thus the objective of the study is to compare 2 cryotherapy techniques associated with a classic rehabilitation on the improvement of mobility, swelling, pain and functional parameters. The 2 cryotherapies were a compressive cryotherapy and a so-called classic cryotherapy by cold pack.


Eligibility Criteria:
Inclusion Criteria:

* Volunteers
* First-line Total Knee Arthroplasty on an indication of knee osteoarthritis diagnosed by radio-clinical examination
* Between D3 and D10 postoperatively
* Age \< 90 years.

Exclusion Criteria:

* Intolerance to cryotherapy or compression,
* Occurrence of complications secondary to surgery,
* Withdrawal of consent,
* Non-compliance with the rehabilitation protocol (content and dosage of sessions).
Impulsivity With Borderline Personality Disorder/tMS

This is a prospective, randomized, double-blind, parallel-group controlled trial. The aim of this research project is to compare the clinical benefits achieved in patients with Borderline Personality Disorder (BPD) following two types of intervention: ccPAS active or ccPAS sham.

Borderline personality disorder (BPD) is a mental disorder characterized by unstable interpersonal relationships, emotional lability and marked impulsivity. The latter manifests itself through risky behaviors such as substance abuse, self-harm and suicidal behavior.

Studies suggest that 1.3% of the general population suffers from BPD. However, in clinical settings, BPD patients represent 20% of all inpatients in psychiatric wards and up to 50% of patients hospitalized in emergency departments following a suicide attempt (SA). Moreover, it is estimated that nearly 84% of BPD patients will make at least one SA in their lifetime and up to 10% of them will die by suicide, a rate 50 times higher than the general population. Impulsivity, reflected in difficulties holding back action or stopping an action that has already begun, is one of the key symptoms of BPD.

Recent advances in non-invasive brain stimulation have led to the emergence of a new stimulation protocol known as Paired Cortico-Cortical Associative Stimulation (ccPAS), which consists of repeating paired stimulations using two TMS coils placed respectively on two cortical regions of interest. Paired stimulations' repetition induces plasticity by strengthening synaptic connectivity between the two targeted regions.

The aim of this project is to test the efficacy of a ccPAS protocol in enhancing effective connectivity between the IFC and pre-SMA in order to reduce impulsivity in BPD patients.

The Sponsor hypothesized that one ccPAS session, using two coils simultaneously, targeting the IFC and pre-SMA with a 'physiological' inter-stimulus interval of 4ms will improve motor inhibition abilities (reduce SSRT), compared to the group receiving 'control' ccPAS (100ms inter-stimulus interval (ccPAS100-ms)).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of BPD (established by a psychiatrist and confirmed in a structured interview using the MINI) based on the Diagnostic and Statistical Manual of Mental Disorders (DSM V).

Exclusion Criteria:

* Contraindications to TMS/MRI (pacemakers or other devices likely to interfere with the magnetic field).
* Pregnant or breast-feeding women.
* Ongoing anxiolytic treatment (benzodiazepines), neuroleptic treatment or anticonvulsants acting on GABAergic transmission ; 24 hours prior to the protocol.
* Diagnosis of other chronic psychiatric pathology including bipolar disorder type I or II and addictions (except tobacco).
* Protective measure (curatorship or guardianship)
Assessment of Endoscopic Tip Control Using a Novel Score Based on the Snare Tip Soft Coagulation of Polypectomy Margin Defects

Colorectal cancer is the third most common malignancy worldwide and the second leading cause of cancer related death with approximately 880 792 deaths every year (9,2% of the global yearly 9.6 million cancer deaths). Screening for polyps is done by colonoscopy, which is considered the gold standard for screening and removal of polyps and has been proven to reduce the global colorectal cancer burden significantly. Endoscopic removal of polyps is preferred because of its efficiency, cost-effectiveness, and safety in comparison to surgery.

Endoscopic tip control is a fundamental component of high quality endoscopy. Endoscopic procedures are complex processes where cognitive processing and motoric output need to be perfectly aligned. This is reflected in endoscopic tip control. It is indispensable in every step of endoscopy: during insertion of the endoscope, where the tip of the endoscope needs to reach the caecum/terminal ileum/duodenum, without discomfort for the patient if under light sedation, during withdrawal of the endoscope in order not to miss any lesions, and also during every endoscopic treatment whether it is a simple polypectomy or a complex therapeutic procedure performed by expert endoscopists.

However, there is currently no tool available to assess endoscopic tip control. And very little is known about educating it.

The investigators developed a new, web-based scoring system to assess tip control. The intent of this study is to validate this novel tool so it can be used to assess endoscopists and evaluate their progress when training in endoscopy.

This study takes place at the University Hospital Ghent, which is a tertiary care center for gastrointestinal endoscopy. The investigators will validate the tool in this study, through assessment of endoscopists of varying experience while they use a technique of snare tip soft coagulation on the margin of a polypectomy defect. This technique has proven its use in preventing recurrence after polypectomy. The technique uses the tip of a snare (used to resect polyps) to deliver thermal energy to the margin of a polypectomy, also called margin ablation. Thermal energy is applied by a hit on a pedal (operated with the foot), every hit needs to be exactly on the margin of the defect (not in the defect, not on normal mucosa around the defect). This requires a very steady and controlled handling of the endoscope and is an ideal technique to assess endoscopist's tip control. The score system will calculate the accuracy (number of correct hits over number of wrong hits) of tip control per second.


Eligibility Criteria:
Inclusion Criteria:

* Endoscopists who perform endoscopic mucosal resections (EMR) at the University Hospital of Ghent, Belgium (UZ Gent)
* Patients, \> 18 years of age, referred for EMR needing snare tip soft coagulation of the defect margins.

Exclusion Criteria:

* Endoscopists who do not consent to the study
* Patients who do not consent to the study
A Study to Assess the Effect of Phenytoin on the Drug Levels of Afimetoran and the Effect of Afimetoran on the Drug Levels of Midazolam

This study will consist of 2 parts. The study will evaluate whether administration of phenytoin impacts the single-dose drug levels of afimetoran and BMT-271199 (Part 1) and will evaluate whether multiple administrations of afimetoran impact the drug levels of midazolam and 1-hydroxymidazolam (Part 2).


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) of 19.0 kilograms per meter squared (kg/m\^2) to 32.0 kg/m2, inclusive, and body weight ≥ 55 kg, at screening.

Exclusion Criteria:

* Any significant acute or chronic medical illness or any other condition listed as a contraindication in the phenytoin (Part 1) or midazolam (Part 2) package inserts.
* History of seizure (including simple febrile seizure), epilepsy, severe head injury (including concussion), multiple sclerosis, or other known neurological condition which the investigator considers to be clinically significant.
* Current or recent (within 3 months of study intervention administration) GI disease that could impact upon the absorption of study intervention.

Other protocol-defined inclusion/exclusion criteria apply.
Cardiorenal Syndrome in End-Stage Kidney Disease

Cardiorenal Syndrome (CRS) is prevalent among end-stage renal disease (ESRD) patients. Recently, its prevalence is rising. There are several different clinical presentations of this syndrome. It has a high rate of morbidity and mortality.

The purpose of this study is to find the connection between the heart pathology and its effect on ESRD patients. This will aid in choosing the appropriate medical therapy for these patients, and hopefully, aid in increasing their quality of life, and decrease their morbidity and mortality.


Eligibility Criteria:
Inclusion Criteria:

* End-stage renal patients

Exclusion Criteria:

* Cancer patients
Treatment In Acute Benign Paroxysmal Positional Vertigo

Benign paroxysmal positional vertigo (BPPV) is a vestibular disorder that manifests itself as a result of dizziness caused by the otoconia in the inner ear coming out of their places and circulating freely in the semicircular canals or by attaching to the cupula and sensitizing the cupula to head movements against gravity. The aim of the study is to compare the effectiveness of pharmacological treatment initiated by the physician and vestibular rehabilitation initiated by physiotherapist in patients with acute benign paroxysmal positional vertigo (BPPV). Thirty patients, aged 18-50 years, who applied to the Bağcılar Safa Hospital, were included in the study. The patients were divided into two groups, 15 pharmacological control group and 15 vestibular rehabilitation group. 8 patients in the pharmacological control group were given the drug containing betahistine by the physician, and 7 patients received the drug containing additional dimenhydrinate to the betahistine. In the rehabilitation group, exercises including head and eye movements and maneuvering were performed according to the direction of the canal after the exercise, and the patients were given a home exercise program. Treatment continued for 4 weeks. Visual Analogue Scale (VAS), dynamic visual acuity test, romberg, semitandem, tandem posture tests with a stopwatch, standing test on one leg with eyes open and closed, and unterberger tests were applied to patients before and after treatment.


Eligibility Criteria:
Inclusion Criteria:

* 18-50 years of age,
* Positive Dix-Hallpike test result, and
* No spontaneous nystagmus.

Exclusion Criteria:

* Patients with Meniere's disease, vestibular neuritis, labyrinthitis, sudden sensory hearing loss, chronic otitis media, non-ambulatory patients, patients with vertigo due to central causes, and patients with cardiac complaints were excluded from the study.
* In addition, patients with conditions contraindicated for canalith repositioning procedures (such as cervical spine stenosis, severe kyphoscoliosis, cervical radiculopathy, ankylosing spondylitis, severe lumbar dysfunction, and spinal injuries) were excluded from the vestibular rehabilitation group.
Development of Continuous Glucose Monitoring System Cohort for Personalized Diabetes Prevention and Management Platform

The purpose of this study is to collect a variety of clinical data and blood glucose changes using a continuous glucose monitoring device for high-risk diabetes patients (prediabetes) in order to develop a personalized diabetes prevention and management platform based on artificial intelligence model using mathematical analysis.

After being informed about the study and potential risks, all patients giving written informed consent wear a continuous glucose monitoring device ("iPro2" professional continuous glucose monitoring, MedtronicⓇ, California, USA) and smart band ("Fitbit Inspire HR", FitbitⓇ, California, USA) for 1 week.

During this period, all patients are tested oral glucose tolerance test and take a standard diet (calorie calculated) at morning.

The patient's data from this study is compared to a predicted values by mathematical analysis model for diabetes prevention.

Eligibility Criteria:
Inclusion Criteria:

* Above 18 years old.
* Prediabetes

  1. Fasting plasma glucose : 100\~125mg/dL, fasting is defined as no caloric intake for at least 8 hours.

     OR
  2. 2-hour plasma glucose during 75g oral glucose tolerance test : 140 \~ 199mg/dL

     OR
  3. Glycated hemoglobin(HbA1c) : 5.7\~6.4% (39-47mmol/mol)

Exclusion Criteria:

* with a history of newly diagnosed and treated cancer within the last 5 years
* with a history of hospitalization for active disease within the last 3 months
* with a history of severe cardiovascular disease within the last 3 months
* with a history of steroid treatment in the last 3 months
* people who have had major surgery planned within the last 3 months or who have had surgery within 3 months
* people who are pregnant or have been in the last 3 months after giving birth
Impact of Physical Activity for Chronic Pelvic Pain

The purpose of this pilot study is to evaluate the impact of an intervention to increase physical activity on pain, function and quality of life in women with chronic pelvic pain.

The primary aim of this pilot study is to evaluate the impact of moderate-intensity physical activity on pelvic pain in women with chronic pelvic pain. We will develop a moderate-intensity physical activity program for patients with chronic pelvic pain in conjunction with exercise physiologists and physical medicine and rehabilitation (PM\&R) physicians. Based on prior research in fibromyalgia and other centralized pain disorders, we hypothesize that eight weeks of moderate-intensity physical activity will reduce pain intensity and pain interference in women with chronic pelvic pain. We will also evaluate the impact of moderate-intensity physical activity on physical function, fatigue, sexual function, sleep, anxiety, depression, catastrophization and patient global impression of change in women with chronic pelvic pain. We hypothesize that eight weeks of moderate-intensity physical activity will result in improvements in these measures of function and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Female
* 18-65 years old
* ≥ 6 months of noncyclic pelvic pain
* Pain that is severe enough to cause functional limitations, defined here as an average self-reported daily pain score of 4 on a 10 point scale
* Willing to attend activity session in Ann Arbor, MI at least 3 times per week
* English speaking

Exclusion Criteria:

* Pelvic surgery within the previous 3 months or plan for pelvic surgery within the following 3 months
* Participation in pelvic floor physical therapy during the 12 week study period
* Medical co-morbidities that prohibit participation in an exercise program, such as significant cardiovascular, pulmonary or orthopedic disease
* Pregnancy
* Documented history of significant dementia
Maraviroc-Based GVHD Prophylaxis in HLA-Unrelated and HLA-Mismatched Related Transplantation

HLA-mismatched unrelated donor (MMUD) and HLA-haploidentical donor (Haplo Donor) hematopoietic stem cell transplantation (HSCT) is associated with increased graft-versus-host-disease (GVHD) and impaired survival. The chemokine receptor 5 (CCR5) antagonist maraviroc has immunomodulatory properties potentially beneficial for GVHD control as it can blockade lymphocyte chemotaxis without impairing T-cell function. The aim of this study is to evaluate the safety and efficacy of maraviroc combined with standard graft-versus-host-disease prophylaxis in patients with hematologic malignancies after allogeneic stem cell transplantation from HLA-Unrelated or HLA-Mismatched Related donors. Based on the results of our previously small sample study with maraviroc combined with cyclosporine/tacrolimus and methotrexate for prophylaxis of GVHD, the investigators plan to perform the clinical trail.


Eligibility Criteria:
Inclusion Criteria:

1. Age 12-65 years (patient is older than 12.0 and less than 66.0 years old)
2. Patients with acute leukemia, myelodysplastic syndrome or lymphoma who scheduled to undergo allogeneic stem-cell transplantation from HLA-Unrelated or HLA-Mismatched Related donors
3. Renal function: estimated creatinine clearance greater than 40 mL/minute (using the Cockcroft-Gault formula and actual body weight)
4. Hepatic function: Baseline direct bilirubin, alanine aminotransferase (ALT) lower than three times the upper limit of normal
5. Pulmonary disease: forced vital capacity (FVC) or forced expiratory volume at one second (FEV1) \> 40% predicted
6. Cardiac ejection fraction \> 40%
7. Signed informed consent

Exclusion Criteria:

1. Patients not expected to be available for follow-up in our institution for at least 100 days after the transplant
2. Prior allogeneic transplant
3. Karnofsky Performance Score \< 70%
4. Patients who are not undergoing standard GVHD prophylaxis with cyclosporine/tacrolimus and methotrexate
5. Patients with uncontrolled bacterial, viral or fungal infections
6. Patients receiving other investigational drugs for GVHD