cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Drug Combinations Against Schistosomiasis

This randomised, controlled, double-blinded clinical study investigates the safety and efficacy of MBD in combination with PZQ in the treatment of SCH and STH in children aged 1-15 years of age.


Eligibility Criteria:
Inclusion Criteria:

* Those with an age of 1-15 years of age
* Are infected with schistosomiasis and soil-transmitted helminthiasis
* Whose parent consent and who are willing to participate

Exclusion Criteria:

* Those with acute and chronic diseases other than schistosomiasis and soil-transmitted helminthiasis
* Those with a history of any serious adverse drug reactions
Feasibility and Effectiveness of a Ring-type Blood Pressure Measurement Device

The goal of this clinical trial is to evaluate the feasibility and effectiveness of a ring-type blood pressure measurement device compared to a 24-hour ambulatory blood pressure monitoring device in patients with hypertension or suspected hypertension. The main question it aims to answer is whether the 24-hour blood pressure measurement accuracy of the ring-type blood pressure monitor is similar to that of the 24-hour ambulatory blood pressure monitor. To participate, subjects must wear a ring blood pressure monitor and an ambulatory blood pressure monitor simultaneously for 24 hours.


Eligibility Criteria:
Inclusion Criteria:

1. Patients scheduled for 24-hour ambulatory blood pressure monitoring for diagnostic purposes among those suspected of having hypertension
2. Confirmed hypertensive patients scheduled for 24-hour ambulatory blood pressure monitoring for treatment purposes

   * Either criterion 1 or 2 are planned to be selected as study participants.

Exclusion Criteria:

* Participants who do not consent to the study
* Individuals with a Body Mass Index of 30 or above (there's a concern of measurement errors as the standard 24-hour ambulatory blood pressure cuffs may not fit well)
* Pregnancy
* Baseline heart disease patients: individuals with a history of hospitalization due to heart failure, valvular disease, or myocardial infarction
* Patients diagnosed with atrial fibrillation on a 12 lead EKG within the past 6 months
* End-stage renal disease (patients undergoing dialysis)
* Users of mobile phones that are not compatible with the test device (CART-I plus) used in the study
Intraoperative Laser Speckle Contrast Imaging of Cerebral Blood Flow

The purpose of this research study is to evaluate the ability of laser speckle contrast imaging to visualize blood flow in real time during neurosurgery. Real-time blood flow visualization during surgery could help neurosurgeons better understand the consequences of vascular occlusion events during surgery, recognize potential adverse complications, and thus prompt timely intervention to reduce the risk of stroke. The current standard for visualizing cerebral blood flow during surgery is indocyanine green angiography (ICGA), which involves administering a bolus of fluorescent dye intravenously and imaging the wash-in of the dye to determine which vessels are perfused. Unfortunately, ICGA can only be used a few times during a surgery due to the need to inject a fluorescent dye, and provides only an instantaneous view of perfusion rather than a continuous view. Laser speckle contrast imaging does not require any dyes or tissue contact and has the potential to provide complementary information to ICGA. In this study we plant to collect blood flow images with laser speckle contrast imaging and to compare the images with ICGA that is performed as part of routine care during neurovascular surgical procedures such as aneurysm clipping.


Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years or older).
* Size of craniotomy at least 2 cm.
* Possibility of intraoperative ICGA.
* Able to render written informed consent.

Exclusion Criteria:

* Patients unable to legally consent.
* Patients with impaired cognitive function.
Assessment of Neural Inspiratory Time Through sEMG and EMGdi

The onset and offset of the neural inspiratory time are fundamentally important measurements in studies of patientventilator interaction, where the level of assistance delivered by the ventilator is controlled by the patient's demand. The onset of neural inspiratory time can be determined in esophageal pressure, transdiaphragmatic pressure, and EMG signals. The investigator compare the onset measured by EMG, esophageal and transdiaphragmatic pressure, and consider that the correlation between them is well in different conditions.

The onset and offset of the neural inspiratory time are fundamentally important measurements in studies of patien-tventilator interaction, where the level of assistance delivered by the ventilator is controlled by the patient's demand. Patient-ventilator asynchrony evaluated using the time lag between onset of the neural inspiratory time and the onset of a mechanical ventilation signal. The onset of neural inspiratory time can be determined in esophageal pressure, transdiaphragmatic pressure, and EMG signals. The investigator compare the onset measured by EMG, esophageal and transdiaphragmatic pressure, and consider that the correlation between them is well in three different conditions.

Eligibility Criteria:
Inclusion Criteria:

* normal cardio-pulmonary function
* without low inspiratory muscle strength
* non-smoker
* without history of the nervous system and respiratory system disease
* sever to very severe stable stage

Exclusion Criteria:

* systemic application of corticosteroids nearly 4 weeks
Clavicular Shortening Post-fracture - Does it Change? - a Prospective Study of 70 Patients

In an attempt to answer if clavicular length changes after a fracture e.g. that any shortening becomes worse or better, 70 patients will be followed 3 times over 21 days using a novel ultrasound method.


Eligibility Criteria:
Inclusion Criteria:

All patients who sustain a displaced medial, mid and lateral clavicle fracture from March 2014 to August 2015 referred from Slagelse and Holbæk emergency departments are eligible. The last patients are seen end of mid-July 2015 given the 21 days of follow up.

Exclusion Criteria:

Patients that have bilateral clavicle fractures and/or prior operations involving the clavicle are excluded. Malignant diagnoses are excluded.
Sodium Chloride vs. Glucose Solute as a Volume Replacement Therapy During Decongestion in Acute Heart Failure

The aim of the study is to compare the differences in diuretic, natriuretic and clinical response to decongestion in patients receiving different replacement fluid regimens (0.9% sodium chloride vs 5% glucose) in acute heart failure.


Eligibility Criteria:
Inclusion Criteria:

* patients \>18 years old who sign the informed consent
* the primary cause of hospitalization is Acute Heart Failure with a need for intravenous Furosemide
* the start of the study within 24h of hospital admission

Exclusion Criteria:

* need for inotropic support
* end stage renal disease on dialysis
* serum sodium \> 148mmol/l or \< 130 mmol/l.
Pharmacogenetic Testing on an Outpatient Population With a Depression Diagnosis

This is a randomized, control group design of pharmacogenetic implementation in a mental health population of subjects taking anti-depressants and/or anti-psychotics with a new or current primary or secondary diagnosis of Major Depressive Disorder (MDD) or Depressive Disorder Not Otherwise Specified (DDNOS).

Mental illness affects one in four adults in the United States; approximately 61.5 million Americans experience mental illness in a given year. According to the National Alliance for the Mentally Ill, the impact of serious mental illness costs Americans $193.2 billion in lost earnings per year. In addition, mental illness patients have an increased risk of having chronic medical conditions, leading to increased costs and emergency service utilization for those conditions. In addition to substantial costs, patients with psychiatric illness are difficult to treat. More than two-thirds of patients with depression do not respond to first line therapy. Treatment often involves numerous trials of individual agents and combinations of medications in order to achieve optimal response. Pharmacogenetic testing is being used in more settings to guide treatment decisions.

Eligibility Criteria:
Inclusion Criteria:

* Current primary or secondary diagnosis of Major Depressive Disorder or Depressive Disorder Not Otherwise Specified
* Have moderate to severe depression as identified by PHQ-9 scoring of 10 or greater
* Taking or be newly prescribed an anti-depressant or anti-psychotic medication
* Able to provide informed consent

Exclusion Criteria:

* Pregnant or breastfeeding
* Active and/or unstable diagnosis of substance abuse, excluding nicotine
* Primary diagnosis of dementia, bipolar disorder (any type), schizophrenia, schioaffective disorder, or personality disorder
SARC037: A Phase I/II Study to Evaluate the Safety of Trabectedin in Combination With Irinotecan in Ewing Sarcoma Patients

This study evaluates the trabectedin and irinotecan in the treatment of Ewings sarcoma, with a EWS-FLI1 mutation. Patients will also receive an infusion of 18F-FLT in combination with a Positron Emission Tomography (PET) scan to help evaluate the effect of treatment.

Phase I was completed on 11/16/2022. Phase II is actively recruiting.

Trabectedin and Irinotecan may inhibit the activity of this Ewing sarcoma mutation. Trabectedin may suppress the proliferation of the gene involved in DNA damage response. It blocks EWS-FLI1 by inactivating the fusion protein and silences the target genes.

Irinotecan also suppresses the genes regulating the tumor cells, generating DNA damage. Together, these drugs work in combination to suppress the gene regulating the tumor cells. This combination may suppress the activity of the tumor regulating genes, disrupting the activity of the genes. The infusion of 18F-FLT in combination with a Positron Emission Tomography (PET) scan will demonstrate whether the target cells have been suppressed.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of relapsed and refractory Ewing sarcoma with EWS-FLI1 fusion type for which there is no known therapy proving to prolong survival
* measurable disease
* ECOG Performance Status of 0-2 or Lansky of 50
* adequate organ function
* written, voluntary consent
* willing to undergo tumor biopsy
* negative hepatitis infection

Exclusion Criteria:

* prior therapy with trabectedin or lurbinectedin
* known history of hypersensitivity to irinotecan or topotecan or their excipients.
* known brain metastases
* known bleeding diathesis
* pregnant or breastfeeding
* currently receiving other investigational drugs or anticancer agents
* clinically significant unrelated illness or uncontrolled infection
* unable to comply with the safety monitoring requirements
Multidrug Blister Pack Study

The purpose of this study is to determine the benefit of patients using a multidrug blister packs after discharged from an university hospital to their homes.

Typical adherence rates for oral prescription medications are approximately 50-76%. Insufficient adherence causes an increase in morbidity, mortality, and costs, and decreases quality of life of patients. Multidrug blister packs are recommended to improve adherence and are widely used in Switzerland. However, evidence is poor and patient-relevant endpoints are seldom measured. This study was designed to compare patient-relevant outcomes in patients with medication repackaged in multidrug blister packs versus patients with medication dispensed in commercially available packages. Adherence of the intervention group will be monitored electronically and feedback will be given to the patients. The intervention will take place in a study pharmacy. Follow-up visits will take place at the study pharmacy at 3, 6, and 12 months for all patients. Study duration will be 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Prescription of 4 or more different oral solid drugs
* Capable to understand german (verbally and written)
* Capable to give informed consent
* Insured by a Swiss health insurance
* Manages his/her pharmacotherapy without external support
* Obtains his/her medication from a community pharmacy
* Accepts to use an electronic multidrug blister pack
* Place of domicile in Basel-Stadt or Basel-Land

Exclusion Criteria:

* Pregnancy
* \> 2 drugs that cannot be packed into a multidrug blister pack (e.g. fluids)
* Dementia, or evaluated as cognitively impaired by the responsible nurse
* Transplanted patient
* Anticoagulation with oral vitamin K antagonists
* Has already used a multidrug blister pack of Pharmis or a Medifilm® single dose system
* is visually impaired (blind)
* cannot push drugs through a blister
* refuses to allow contact to his/her regular pharmacy and GP
* is referred to a nursing home or to rehabilitation or another hospital at discharge
* is included in other clinical trial
Health in Smart Rurality: Impact on Coordination of Care of Telemonitoring and Data Centralization of Frailty Patients

Chronic diseases are frequent (around 10% of the total population and 30% after 60 years) and accelerate age-related functional decline. Concerning cross-border patients, use of health services can be delayed given the distances, the lack of rapid road access and the limited availability of public transport and the complex organization of coordinated care.

One of the ways to reduce acute exacerbations and preserve the quality of life of patients is to detect warning signs early. One of the ways to do this is to use new communication technologies.

The aim of the study is to assess feasibility of using a connected tablet to assess clinical parameters with an alert system in frailty patients aged over 60, living at home, with heart failure and / or chronic obstructive pulmonary disease, potentially requiring care cross-border (France and Belgium).

Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 60
* Patients living at home
* Patients with heart failure and / or chronic obstructive pulmonary disease,
* Patients potentially requiring care cross-border (France and Belgium).
* Patients agreeing to participate to the study

Exclusion Criteria:

* Patients who do not speak French
* Patients with severe cognitive impairment
Brief Strategic Family Therapy for Adolescent Drug Abusers

The purpose of this study is to compare Brief Strategic Family Therapy (BSFT) for Adolescent Drug Abusers to treatment as usual (TAU).

An additional follow up assessment, funded by an American Recovery \& Reinvestment Act (ARRA) grant, was completed 5 years post randomization in order to examine the long term effects of outpatient treatments for illicit drug using adolescents.

Adolescent drug abuse continues to be one of the most pressing public health issues in the United States-our nation's teenagers continue to use illicit drugs at a worrisome rate. Broad reviews of the treatment outcome literature indicate that family interventions in general, and Brief Strategic Family Therapy (BSFT) in particular, are effective with drug using youth. This study is designed to compare BSFT to treatment as usual (TAU). The researchers believe that BSFT will be much more effective than TAU in reducing adolescent drug use. They will also examine which of these treatment approaches does a better job of engaging adolescents and family members in treatment, decreasing problem behaviors, decreasing sexually risky behaviors, increasing pro-social activities (e.g., school, work), and improving the functioning of the family.

With the addition of the extended follow up, we have the opportunity to examine the sustainability of study outcomes into early adulthood, filling a gap in the treatment research literature about the long-term effects of adolescent substance abuse treatment. The follow up study examined the long term effectiveness of BSFT compared to TAU in the rates of substance use, number of arrests and externalizing behaviors, in youth who received study treatments at the time when they were adolescents.

Eligibility Criteria:
Main Study:

Inclusion Criteria:

* adolescents ages 12 to 17
* used any illicit drugs (other than alcohol and tobacco) in the 30-day period
* live with or intend to live with a formal or informal family

Exclusion Criteria:

* suicidal or homicidal ideation.

Follow Up Study:

Inclusion Criteria:

* youth must have signed consent during the main study to be approached for future research
* currently 18 years old or older
A Quality of Life and Safety Study With Pimecrolimus Cream, 1% in Children (Age 2-12 Years) With Atopic Dermatitis

The study will evaluate the safety and effect of pimecrolimus cream 1% on quality of life of caregivers of South African children with mild to moderate atopic dermatitis (AD).


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age ≥2 years ≤12 years of age
* Atopic dermatitis on sensitive skin areas only ( i.e. face , neck and flexures )
* Subjects in whom other treatment modalities are inadvisable according to the investigator's clinical opinion or have failed on other treatment modalities due to intolerance or inadequate response.
* Patients with a history of mild to moderate AD
* Subjects should present at visit 1 with a clear clinical diagnosis of mild to moderate AD.
* Subject's parents or legal guardian must have been informed of the study procedures and must have signed the Informed Consent form approved for the study prior to any study related procedures

Exclusion Criteria:

* Subjects who have active viral infections at the site(s) of treatment. In the presence of other dermatological infections, the use of appropriate antimicrobial agents should be instituted.
* Subjects who present with systemic malignancy or active lymphoproliferative diseases/disorders (e.g., lymphoma, neoplastic disease, chronic lymphoproliferation).
* Subjects who present with clinical conditions other than AD that can, in the opinion of the investigator, interfere with the evaluation
* Subjects who are receiving photo-therapy (e.g., PUVA, UVB) or immunosuppressive therapy (e.g., cyclosporine, FK-506 \[tacrolimus\]).
* Subjects who have used investigational drugs within 8 weeks prior to first application of study medication or intended use of other investigational drugs during the course of this study.
* Subjects who have used, or are using 0.03% or 0.1% tacrolimus ointment.
* Pimecrolimus cream 1% is contraindicated in subjects who have known or suspected hypersensitivity to pimecrolimus or any components of the cream
* Subjects not medically stable or subjects with any condition which, in the opinion of the investigator, should render the subject ineligible for the study.
* Pregnancy and lactation (if applicable)
* Pimecrolimus cream 1% should not be used during pregnancy or lactation

Other protocol-defined inclusion/exclusion criteria may apply
Phrenic Nerve Stimulation-Induced Lung ReAeration Trial

The Lungpacer PROTECT Diaphragm Pacing Therapy System (DPTS) is a temporary, percutaneously-placed, transvenous, phrenic nerve-stimulating device intended to stimulate the diaphragm to preserve and improve inspiratory muscle strength in mechanically ventilated patients. The purpose of the PROTECT DPTS is to improve gas exchange, regional lung ventilation, and hemodynamics, and decrease atelectasis in patients presenting with acute respiratory distress syndrome (ARDS).

The PIRAT clinical study is intended to assess the feasibility, safety and effectiveness of transvenous phrenic-nerve-stimulating diaphragm pacing on clinical outcomes in mechanically ventilated patients. By delivering electrical stimulation to the phrenic nerves, which in turn causes the diaphragm muscle to contract, the PROTECT DPTS is intended to protect the diaphragm from atrophy and preserve lung mechanics to reduce lung inflammation and injury associated with short-term mechanical ventilation. Sustained lung and diaphragm health during early mechanical ventilation is expected to reduce the risk of comorbidities, improve clinical outcomes such as weaning success, and thereby reduce the number of patients who require prolonged mechanical ventilation.

Eligibility Criteria:
Inclusion Criteria:

* Are 18 years or older
* Have been mechanically ventilated due to moderate ARDS for 48-120h
* Have a PaO2/FiO2 ratio \< 200 and \> 100 at the time of screening with PEEP ≥ 5 cmH2O
* Are expected to remain on mechanical ventilation ≥ 48 hours
* Are under continuous sedation with Richmond Agitation Sedation Scale (RASS) ≤ -3

Exclusion Criteria:

* Septic shock with hemodynamic instability (norepinephrine or epinephrine \< 0.5 gamma/kg/min)
* Catheter access to left subclavian vein deemed impossible
* Use of neuromuscular blocking agents within last 12 hours
* Bacteremia within the last 48 hours or uncontrolled source of infection
* Currently on ECMO
* Enrolled in any other study of an investigational drug or device, which may affect the outcomes of the current study
* Pre-existing neurological, neuromuscular or muscular disorder that could affect the respiratory muscles
* BMI \>45 kg/m2
* Known or suspected phrenic nerve paralysis
* Any electrical device (implanted or external) that may be prone to interaction with or interference from the Lungpacer PROTECT DPTS, including neurological pacing/stimulator devices and cardiac pacemakers and defibrillators
* No affiliation to the French health insurance system
* Under curatorship
* Imprisoned
* Known or suspected to be pregnant or lactating
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old

Evaluate the feasibility and safety, obtaining initial efficacy data, of expanded allogeneic mesenchymal stem cells derived from adipose tissue (HC106) for the treatment of urinary incontinence in women over 50 years of age.

It's a controlled trial, in phase I, proof of concept, safety and preliminary analysis of efficacy. It is planned to make 2 cohorts of patients, one with a single dose of 40 million HC016 and another group with saline solution (control).

Eligibility Criteria:
Inclusion Criteria:

* Women over 50 years old
* Women with a clinical diagnosis of genuine or mixed stress urinary incontinence (SUI) with at least 6 months of evolution. Using the definitions of urinary incontinence internationally accepted by the ICS (International Continence Society): to. SUI: any involuntary loss of urine, immediately preceded by exertion. b. Mixed UI: any involuntary loss of urine, immediately preceded by exertion or an uncontrollable desire to urinate.

The predominance of effort will be assessed when more than 50% of the patient's daily losses occur preceded by effort.

* Women in whom rehabilitative treatment has failed or patients who refuse to undergo rehabilitative or surgical treatment
* Patients without active urinary tract infection (negative urine culture) at the time of recruitment and treatment
* Signing of the informed consent form

Exclusion Criteria:

* Patients with a medical history of previous surgery for incontinence, prolapse or urological/gynecological/colorectal surgery
* Major surgery or serious trauma of the subject in the previous semester
* Women with mixed urinary incontinence, with predominant symptoms of urgency
* History of high-pressure detrusor overactivity
* Present infravesical obstruction, vesico-ureteral reflux or clinical history of urinary fistula (it will be ruled out depending on the case by urethrocystoscopy, urethrocystography and flowmetry).
* Present any malignant neoplasm, unless it is basal cell or squamous cell carcinoma of the skin, or present a history of malignant tumors, unless they have been in remission during the previous 5 years.
* Cardiopulmonary disease that, in the opinion of the investigator, is unstable or serious enough to exclude the patient from the study.
* Medical or psychiatric illness of any type that, in the opinion of the researcher, may be a reason for exclusion from the study.
* History of alcohol or other addictive substance abuse in the 6 months prior to inclusion
* Subject's allergy to anesthetics