cyrilzakka/clinical-trials huggingface dataset:
Non-Invasive Mechanical Ventilation in Elderly Patients

The efficacy of NIMV to treat HARF has been widely demonstrated. However, in most of the studies performed in ICUs and in another facilities the mean age of the patients is usually less than 70 years.

A multicentric, randomized-controlled trial conduced in a group of "ELDERLY" patients with the mean age higher than 76 years, to compare the use of NIMV with Standard Medical Treatment (SMT) in the treatment of an episode of Acute Hypercapnic Respiratory Failure.

Non-invasive mechanical ventilation (NIMV) has been successfully used in Hypercapnic Acute Respiratory Failure (HARF) since endotracheal intubation (ETI) and invasive ventilation are associated to high morbidity and mortality rate.

because of the lack of beds in most Intensive Care Units (ICUs) and the high mortality and cost associated with the increased of age, the "Elderly" patients affected by ARF due to chronic diseases are not always considered for ETI.

The efficacy of NIMV to treat HARF has been widely demonstrated. However, in most of the studies performed in ICUs and in another facilities the mean age of the patients is usually less than 70 years (see tab1).

Authors MEAN AGE

(yrs) TYPE of STUDY

Bott \<80 COPD NIV vs Medical Therapy

Brochard71±9 COPD NIV vs Medical Therapy

Kramer 66±7 COPD NIV vs Medical Therapy

Andeev 63±4 COPD NIV vs Medical Therapy

Barbe 70±2 COPD NIV vs Medical Therapy

Bardi 68±8 COPD NIV vs Medical Therapy

Plant 69±8 COPD NIV vs Medical Therapy

Thys 71±8 COPD NIV vs sham NIV

Nava 68±8 COPD NIV in weaning

Girault 63±14 NIV in weaning

Ferrer 70±7 NIV in weaning

Hill 71±3 COPD PAV vs PSV

Confalonieri 66±14 PNEUMONIA NIV vs Medical Therapy

Martin 64±17 Miscellaneous NIV vs Medical Therapy

Conti 72±7 COPD NIV vs EI

A multicentric, randomized-controlled trial conducted in a group of "ELDERLY" patients with the mean age higher than 76 years, to compare the use of NIMV with Standard Medical Treatment (SMT) in the treatment of an episode of Acute Hypercapnic Respiratory Failure.

Eligibility Criteria:
Inclusion Criteria:

* Age higher 75 years old
* Hypercapnic acute respiratory failure (PaCO2 greater 50 mmHg and pH lower than 7.35)
* Respiratory rate (RR) higher 25 bpm after 12 hours of standard medical therapy.

Exclusion Criteria:

* Respiratory failure due to pulmonary oedema
* Kelly's score equal or higher than 4
* Cardio-respiratory arrest
* Systolic arterial blood pressure greater than 90 mmHg or severe arrhythmia
* Recent facial, oesophageal and gastric surgery
Platelet Agregation in Patients on ECMO

An observational study in which investigators will observe platelet inhibition in patients on VA ECMO acorrding to treatment with P2Y12 inhibitor.

Investigators will perform an observational study in which platelet inhibition in patients on VA ECMO acorrding to treatment with P2Y12 inhibitor will be observed.

Participants will be divided into three groups:

A: patients on V-A ECMO without P2Y12 inhibitors B patients on V-A ECMO with P2Y12 inhibitors with administration of P2Y12 inhibitor at the time of ECMO insertion C: patients on V-A ECMO already recieving P2Y12 inhibitors at the time of ECMO insertion.

Blood samples will be taken prior to and at 2, 4, 12, 22, 48, 72 after ECMO insertion and after removal of an ECMO. VerifyNow System will be used to measure platelet agregation (PRU test).

Eligibility Criteria:
Inclusion Criteria:

* all patients on VA ECMO

Exclusion Criteria:

* known P2Y12 alergy
* thrombocitopenic patents (\< 50\*109/L),
* patients treated with eptifibatide ali bivalirudin
* patients younger than 18 years
* pregnant patients
Dynamic Contrast-enhanced MRI Combined With IVIM-DWI for Early Prediction of Chemosensitivity in Liver MBC

The purpose of this study is to further use DCE-MRI and ivim-dwi to predict the chemotherapy sensitivity of liver metastasis of breast cancer at an early stage, and to predict the treatment response of tumor at an early stage by using the changes of their functional parameters, and to compare the efficacy and advantages of IVIM functional parameters and DCE-MRI parameters in predicting the efficacy.To explore the efficacy of "perfusion" and "diffusion" parameters of magnetic resonance imaging as "biomarkers" for early prediction of chemotherapy response and prognosis of breast cancer patients with liver metastasis. And to provide guidance for optimizing the clinical treatment scheme of breast cancer patients with liver metastasis.

At the same time, this study will use the method of artificial intelligence to deeply mine the images, and further find out the indicators for early prediction of the therapeutic effect of liver metastasis of breast cancer.

The first MR examination was arranged within 7 days before treatment (baseline). The MRI scanning sequence included conventional T1, T2 weighted imaging, T1+dynamic contrast enhanced imaging, and IVIM-DWI imaging.The second and third MR examinations were arranged within 7 days after the first chemotherapy and the second chemotherapy. The examination steps and parameters were the same as those of the first examination.

Eligibility Criteria:
Inclusion Criteria:

1. The primary lesion was pathologically confirmed to be breast cancer, and the patients diagnosed by two imaging methods or pathologically confirmed to be liver metastasis of breast cancer had at least one liver metastasis with the longest diameter ≥ 10mm;
2. No second primary malignant tumor;
3. ECOG score, 0-2 ;
4. The organ function is normal and can tolerate chemotherapy and other anti-tumor treatments;
5. The patient plans to receive systemic chemotherapy or systemic anti-tumor treatment, and the whole process of cooperative treatment. The patient has good compliance with the planned treatment and follow-up, can understand the research process of this study and sign a written informed consent；
6. Contraception during the study period and within 6 months after treatment, non lactation period.

Exclusion Criteria:

1. For patients contraindicated to MR examination, such as built-in metal instruments and allergy to contrast agents;
2. The patient had diffuse liver metastasis or the number of liver metastatic tumors was more than 5;
3. Patients who cannot complete 2 cycles of chemotherapy or systemic anti-tumor treatment;
4. Unable to cooperate with follow-up；
5. Patients who are not suitable for the study according to the investigator.
Spoton Trial Evaluating the Efficacy on BAlance Disorder sYmptoms (STEADY)

A Randomized, Double Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of SpotOn specs for the Treatment of Chronic Dizziness \& Imbalance.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18≤ years ≤70
* DHI score of at least 36 (moderate to severe handicap)
* One or more symptoms of unsteadiness, dizziness or vertigo are present on most days. Symptoms could vary in intensity however lasts for 3 months or more
* Ability to perform all tests (including computerized test) and interviews
* At least three months after the last Vestibular Balanced Rehabilitation Therapy - (if applicable)
* Gave informed consent for participation in the study

Exclusion Criteria:

* Dizziness disease with fluctuating symptoms
* Any active or non-controlled disease that might cause dizziness and imbalance, unless well controlled for at least 3 months
* Moderate-Severe Depression or Anxiety
* Known related eye disease
* Pregnant women
* Currently taken part in a clinical trial or within 30 days prior to screening
* Concomitant use of any medications that might affect the balance system
HIV Point-of-Care Test Evaluation in Infants

HIV Point-of-Care tests in Babies Study (BABY) - Operational evaluation of HIV Point-of-Care tests for very early infant HIV diagnostics in infants born to HIV infected mothers in Mbeya, Tanzania.

This in-vitro diagnostic (IVD) study in infants born to HIV infected mothers evaluates the reliability and operational feasibility of an HIV Point-of-Care (PoC) test for HIV early infant diagnosis (EID) in a public health setting at obstetric clinics in Mbeya, Tanzania.

Recruitment is planned to take place at 4 obstetric/maternity study sites in and around Mbeya over a time period of 12 months. The HIV PoC test will be validated against the Standard-of-Care diagnostic test, i.e. Dried Blood Spot (DBS) analyses.

The PoC test under investigation is the Xpert HIV-1 Qual produced by Cepheid, Sunnyvale, USA.

Eligibility Criteria:
Inclusion Criteria:

1. Voluntary and informed consent of the mother for her own study participation (if applicable).
2. Voluntary and informed consent of the legal guardian of the child for participation of the child in the study.
3. Mothers/legal guardians ≥18 years of age.
4. Documented maternal HIV infection.
5. Willingness to consent to HIV testing for the child and herself (if applicable).
6. Willing to consent to active tracing including home tracing.

Exclusion Criteria:

1. Deficiency in the mother, rendering it difficult, if not impossible, for her or her infant to take part in the study or understand the information provided to her. This includes alcoholism, drug dependency as well as psychiatric illnesses, suicidal tendencies or any other inability.
2. Having delivered more than 48h ago
3. Prisoners
4. Women presenting with an emergency requiring immediate medical assistance if not resolved at study inclusion.
5. Stillbirths
6. Infant requiring emergency care or born with severe malformation.
7. If within the discretion of the investigator based on recommendation of the gynaecologist or paediatrician in charge study participation would possibly add not acceptable risk or burden to the mother or infant (e.g. significant congenital malformation, health deficiencies, very low birth weight less than 1500g)
8. Unlikely to comply with protocol as judged by the principal investigator or his designate
Effectivity and Safety of Ultrasound-guided Percutaneously Laser Ablation for Refractory Neoplasms

The purpose of this study is to evaluate the safety and efficacy of ultrasonography (US) -guided laser ablation liver, kidney, pancreas, lung and retroperitoneal tumors, the investigators used preoperative and postoperative US/CEUS/CT/MRI to assess lesions, and laboratory tests including the tumor markers to evaluate the general condition of patients. Intraoperative US/CEUS/CT would be applied to monitor ablation lesions.


Eligibility Criteria:
Inclusion Criteria:

* Patients with small hepatocellular carcinoma (single or multiple nodules of less than 3 cm in diameter),
* Patients with Child-Pugh A/B,
* Patients with PLT ≥ 50\*10E9/L and PT ≤ 20s.

Exclusion Criteria:

* Patients with blood coagulation dysfunction, ChildPugh ≥3, severe cardiopulmonary disease, intolerant anesthesia and upper gastrointestinal bleeding in shock.
Drug-drug Interaction Study of Digoxin and AT-527 (R07496998)

Drug-drug interaction study of Digoxin and AT-527 (R07496998)


Eligibility Criteria:
Inclusion Criteria:

* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
* Females must have a negative pregnancy test at Screening and prior to dosing
* Minimum body weight of 50 kg and body mass index (BMI) of 18-32 kg/m2
* Willing to comply with the study requirements and to provide written informed consent

Exclusion Criteria:

* Infected with hepatitis B virus, hepatitis C virus, HIV or SARS-CoV-2
* Abuse of alcohol or drugs
* Use of other investigational drugs within 28 days of dosing
* Concomitant use of prescription medications, or systemic over-the-counter medications
* Other clinically significant medical conditions or laboratory abnormalities
A Study in Healthy Male Volunteers to Investigate a New Drug for the Treatment of Parkinson's Disease

The main purpose of the study is to identify the best dose of V81444 to use in future trials in patients with Parkinson's disease. The study will also explore the effects of V81444 on brain activity and blood flow with tests of mental ability ("cognitive function tests"). It will also check how safe V81444 is and how well it is tolerated after dosing.

In this Phase I, single-centre, open-label, adaptive, single-dose study at multiple dose levels, the relationship between dose and plasma concentration of orally administered V81444 to brain A2A RO was investigated in 6 healthy male volunteers. In addition, the effects of V81444 on regional brain activity and perfusion during tests of cognitive function, and the safety and tolerability of V81444 were assessed. For each subject, the study consisted of a screening visit, a baseline visit, a treatment period, and a safety follow-up visit. The dose of V81444 and timing of scans performed were defined in the protocol for the first 2 subjects only. The dose, nature and timings of assessments for subsequent subjects were determined based on review of emerging receptor binding, pharmacokinetic (PK), pharmacodynamic (PD) and safety information.

In each treatment period, subjects were admitted to the unit on the day before dosing (Day -1), received a single oral dose of V81444 on Day 1 and, subject to satisfactory medical review, were discharged a minimum of 12 h after dosing. Overall, 3 doses of V81444 were assessed (250 mg, 50 mg, and 100 mg), with 2 subjects included at each dose level. PD assessments were performed at baseline and after each dose of V81444 using PET (with the A2A radioligand, to measure brain A2A RO, as well as MRI techniques to investigate the effects of V81444 on regional brain activity and perfusion during cognitive function tests. PK parameters were assessed by assay of V81444 concentration in plasma. Safety and tolerability were assessed by monitoring physical examination findings, adverse events (AEs), vital signs, 12 lead electrocardiogram (ECG) and clinical laboratory safety tests.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers: aged 25 to 55 years, in good general health as determined by medical history, physical examination and screening investigations, and taking no regular medication.
* Confirmation to be sought for all volunteers that their general practitioner has provided an acceptable medical history.

Exclusion Criteria:

* Any significant medical condition or a history of such a condition that the Investigator considers should exclude the subject from the study.

Specific exclusion criteria relate to

* usual caffeine intake and willingness to abstain from caffeine
* history or evidence of clinically significant gastro-intestinal disease
* presence of structural brain abnormality
* contraindications or cautions for MRI scanning
* clotting test results
* exposure to significant levels of ionising radiation in the past
Exercise Intolerance in Post-COVID Patients

The post-COVID syndrome poses an unprecedented challenge to modern society, affecting millions of people worldwide. Persistent fatigue and exercise intolerance are among the most common complaints of these subjects. The mechanisms of exercise intolerance in post-COVID subjects are remained yet unknown, which make the rehabilitation efforts complex and challenging. The overall goals of this project are to: 1) improve physiological understanding of symptoms in this clinical condition, 2) elucidate plausible mechanisms to explain exercise intolerance/symptom exacerbation, and finally 3) provide knowledge that can be directly applied in the clinical setting to improve diagnosis, care, and individualized rehabilitation of subjects with post-COVID syndrome. Post-COVID subjects and age/sex matched healthy controls will undertake a comprehensive set of physiological and functional assessments, followed by 3 experimental visits (in a randomized order), where acute exercise responses will be assessed in either continuous moderate intensity aerobic exercise, high intensity interval exercise, or strength training. The same set of physiological assessments will also be performed after 1 year in both post-COVID subjects and healthy-matched controls to better understand the time course of the syndrome. It is hypothesized that the mechanism responsible for exercise intolerance is linked to specific symptoms and will vary across subjects. However, it is expected that most post-COVID subjects will respond well to at least one type of exercise.


Eligibility Criteria:
Inclusion Criteria:

* Verified test of covid-19 infection (PCR, or antigen or antibody before vaccination) (mandatory only for post-COVID group)
* Symptoms persisting for at least 3 months (validaded with DSQ-PEM questionnarie) (only for post-COVID group)

Exclusion Criteria:

* Subject's complaints may have been present before March 2020
* Previous history cardiovascular, respiratory disease or other autoimmune disease
* History of general anxiety syndrome or somatic symptom disorder
A Prospective, Comparative Study to Explore the Efficacy and Safety of the Five Channels Multiway Deep Transcranial Magnetic Stimulation (TMS) Device in Subjects With Major Depression Disorder (MDD)

The Multiway stimulator is a novel TMS stimulator with several new and unique properties. Currently standard TMS devices include a single channel, and can operate only a single coil. The Multiway stimulator includes five channels which can operate up to five independent TMS coils, either simultaneously or sequentially.

The Multiway device may be used to obtain a differential activation of various brain regions. For instance it can be used to induce high frequency stimulation of a certain brain region, thus inducing facilitation, while simultaneously stimulate at low frequency in another brain region, leading to inhibition.

The purpose of the study is to explore the efficacy and safety of Multiway deep TMS in comparison to a single channel DTMS treatment in subjects with MDD.

Subjects will be treated with one of two designs of the study device (the Multiway Coil TMS Device):

1. Single Channel with a coil placed over the left PFC (10 Hz).
2. Four channels: a. 10 Hz over the left PFC. b. 1 Hz over the right PFC. c. 10 Hz over the left parietal cortex. d. 1 Hz over the right parietal cortex.


Eligibility Criteria:
Inclusion Criteria:

* Outpatient
* Diagnosed by senior psychiatrist as suffering from major depression episode according to DSM IV using the Structured Clinical Interview for DSM-4 (SCID).
* Rating on HDRS-21\>20.
* Age: 18-68 years.
* Treated for the current depressive episode, at least four weeks, with at least one antidepressant in accepted dose, without improvement, according to their medical chart and ATHF ( antidepressant treatment history form) instruction guidelines .
* Gave informed consent for participation in the study.
* Negative answers on safety screening questionnaire for transcranial magnetic stimulation.

Exclusion Criteria:

* Diagnosis as suffering from other diagnosis on axis 1 ( like: schizophrenia, bipolar disorder, psychotic depression, geriatric depression).
* Diagnosis as suffering from Severe Borderline Personality Disorder or hospitalized due to exacerbation related to of borderline personality disorder.
* Substantial suicidal risk as judged by the treating psychiatrist.
* Attempted suicide in the past year.
* Any current unstable medical or surgical illness.
* History of seizure or heat convulsion.
* History of epilepsy or seizure in first degree relatives.
* History of head injury.
* History of any metal in the head (outside the mouth).
* Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips, cochlear implants or any medical pumps.
* History of hearing loss.
* History of drug abuse or alcoholism in the last 6 month.
* Pregnancy or not using a reliable method of birth control.
* Systematic and metabolic unstable disorders.
* Inadequate communication with the patient.
* Under custodial care.
* Participation in current clinical study or clinical study within 30 days prior to this study.
"ACT" for Parents of Children With Autism Spectrum Disorder

The investigators will develop and pilot test an intervention called "ACT for Parents" which aims to decrease stress and improve quality of life in parents of children \< 15 years who have a diagnosis of autism spectrum disorder. A small randomized trial testing phase will be conducted to gather initial data on the treatment feasibility and acceptability, detect treatment effects between groups (ACT for Parents versus Treatment as Usual), and to refine the treatment design for a future clinical trial.

Acceptance and Commitment Therapy (ACT) is an intervention that fosters acceptance of uncomfortable thoughts and emotions as a coping strategy, and encourages engagement in valued behavior in the presence of these emotions. ACT has been successfully applied to parents with similar mental health presentations. Using a randomized controlled study design, investigators seek to gather initial data on the treatment feasibility and acceptability, detect treatment effects in a cohort of parents who have a child (under the age of 15) with autism spectrum disorder.

Eligibility Criteria:
Inclusion Criteria:

* A parent with a child (under the age of 15) with a diagnosis of Pervasive Developmental Disorder-NOS, Asperger's Disorder or Autistic Disorder
* Child with ASD diagnosed by a mental health or medical professional
* Must be comfortable speaking and reading and understanding English

Exclusion Criteria:

* Inability to attend sessions in person on the specified date/time/location of the intervention sessions
* unwillingness to be audio-taped should randomization into the experimental (ACT) group occur.
Investigating the Impact of a Patient-directed Coronary Artery Calcium Score Report

The goal of this study is to examine if communication of image-based cardiovascular risk to patients undergoing coronary artery calcium scoring (CAC) improves patient understanding of their risk for cardiovascular disease when compared with usual care (physician-only report).


Eligibility Criteria:
Inclusion Criteria:

* Age range: from 40 to 89
* Referred for CAC at UHHS

Exclusion Criteria:

* Less than 40 years of age or over 89 years old.
* Underwent CAC at other locations besides UHHS.
Sagittal Plane Correction With Pass-LP Device in Adult Deformity Patients

The purpose of this study is to evaluate the correlation between the restoration of the sagittal balance and the improvement of the Quality of Life for patients with adult scoliosis, treated with a polyaxial system (PASS® LP system) during the 2 years after a spinal fusion surgery.


Eligibility Criteria:
Inclusion criteria

* Lumbar or thoraco-lumbar Adult Deformity requiring posterior spinal instrumentation and fusion like:

  * Scoliosis
  * Kyphosis
  * Kyphoscoliosis
* Patient with a Cobb angle ≥ 30° and/or confirmed sagittal imbalance defined as sagittal vertical axis (SVA) more or equal to 5cm and/or a loss of lumbar lordosis versus the pelvic incidence
* Patient ≥ 21 years old
* Surgery that requires 4 or more levels to be operated
* Patient with complete pre-operative radiographic data: antero-posterior and lateral standing full spine x-rays (from hips to C2) and lateral bending x-rays (standing)
* Patient able to complete a self-administered questionnaire
* Patient able to sign a consent form

Exclusion criteria

* Patient operated with posterior spinal fusion without PASS LP device
* Patients who required a Vertebral Column Resection technique surgery
* Neuromuscular scoliosis or diseases and any neuro-related pathology
* Spinal cord abnormalities with any neurologic symptoms or signs
* Primary abnormalities of bones (e.g. osteogenesis imperfecta)
* Recent significant trauma
* Patient is involved in current medical litigation
* Metabolic spinal pathology
* Pathologic obesity (BMI \> 40)
* Patients with infection (in particularly osteomyelitis)
* Patient \< 21 years old
* Pregnancy or intended to get pregnant during the next 3 years
* Insulin-dependent diabetes
* All other contra-indications given in the PASS® LP System instructions for use
* Patient unable to sign an informed consent form
* Patient unable to complete a self-administered questionnaire