cyrilzakka/clinical-trials huggingface dataset:
Robotic Surgery in Pulmonary Metastasectomy

The study is observational, multicenter retrospective and will involve multiple research centers. The aim is to outline the indications for surgical management with robot-assisted pulmonary metastasectomy through a confrontation of robot-assisted thoracoscopic surgery (RATS) with video-assisted thoracoscopic surgery (VATS) and thoracotomy. The study will focus on pulmonary metastasectomies from any primary solid tumor (with the exception of lung cancer). There are no risks for the patients, as this is a retrospective data collection.

The investigators will identify selection criteria according to ASA score (American Society of Anaesthesiologists physical status classification system ) and co-morbidities, respiratory function, control and staging of the primary pathology, number and position of metastases. The investigators will assess the robotic approach performance in the different anatomical resections (lobectomies, bilobectomies, segmentectomies,pneumectomies) considering potential intra- and post-operative complications, over than rates of positive margins.

It analyses cases of pulmonary metastasectomy performed with a minimally invasive approach such as robot-assisted thoracoscopic surgery (RATS) and video-assisted thoracoscopic surgery (VATS), or with a traditional open approach. More precisely, it will compare RATS vs VATS as well as RATS vs open.

It was decided to exclude simple wedge resections since, in light of the minimal resection of parenchyma and the costs sustained for the equipment, they are preferably carried out by VATS.

Criteria for the inclusion of patients:

1. The patient can be candidate in terms of ASA score, cardiac, kidney, liver and respiratory function
2. The primary pathology is under control or controllable
3. Absence of extrapulmonary metastases that are not controlled or controllable

Exclusion criteria:

* Age \>/=; then 18 years at the moment of surgery
* Patients who cannot undergo surgery, as they do not meet the conditions outlined above.

Eligibility Criteria:
Inclusion Criteria:

* The patient can be candidate in terms of ASA score, cardiac, kidney, liver and respiratory function
* The primary pathology is under control or controllable
* Absence of extrapulmonary metastases that are not controlled or controllable

Exclusion Criteria:

* Age \>/= ; then 18 years at the moment of surgery
* Patients who cannot undergo surgery, as they do not meet the conditions outlined above.
Relationship Between Sensory Processing and Motor Development

The aim of this study is to analyse correlation between the sensory processing and motor development in preterm infants.

The aim of this study is to analyse correlation between the sensory processing and motor development in preterm infants. A total of 60 infants who were born preterm (n=30) and term (n=30), the corrected and chronological ages between 10-12 months, were included in this study. Test of Sensory Function in Infants was used to evaluate sensory processing, and Alberta Infant Motor Scale was used to evaluate motor development.Spearman correlation test indicated strong positive relation between sensory processing and motor development in preterm infants. Given the relationship between sensory processing and motor development in preterm group, for effective implementation of physiotherapy assessments and interventions, it was thought that it is necessary to evaluate the sensory processing as well as the motor development in preterm infants.

Eligibility Criteria:
Inclusion Criteria:

* gestational age lower than 37 month
* corrected age within 10-12 months
* without congenital anomaly or systemic disease
* stay in Neonatal Intensive Care Unit (NICU) at least 2 weeks

Exclusion Criteria:

* taken physiotherapy or sensory integration therapy in any rehabilitation center
* having newborn retinopathy
Nebulized Ketamine for the Treatment of Major Depressive Disorder in an Inpatient Setting

This is a double blind active placebo controlled clinical trial for individuals within an inpatient setting with moderate to severe depression. The purpose of this study is to assess if nebulized ketamine can reduce depressive symptoms.

The objective of this study is to evaluate the effect of ketamine formalized to be dispensed via inhalation, as an adjunct to concomitant medications and therapies on those with moderate to severe depression currently in an inpatient psychiatric unit. Investigators will examine the effects of nebulized ketamine on depressive symptoms.

This is a prospective double-blind placebo controlled study in which an active placebo, Midazolam, will be used. Participants will commit to either 4 visits or 5 visits depending on which treatment arm they are randomized into. All visits can be done remotely, however, days in which the participant will be dosed will have to be in person. During dosing days, the participant will be monitored for a minimum of two hours. Study participant's vitals will be collected at regular intervals during the observation period.

Adult psychiatry inpatients who are 18 years and older with a diagnosis of moderate to severe depression will be screened for enrollment by the study.

Eligibility Criteria:
Inclusion Criteria:

* All individuals 18 years and older within the Institution's inpatient Psychiatry Unit with a Montgomery-Asberg Depression Rating Scale score ≥ 20
* Must have a diagnosis of moderate to severe Major Depressive Disorder
* Structured Clinical Interview for DSM-5 (SCID-5) will be performed to confirm MDD diagnosis

Exclusion Criteria:

* Adult patients with an allergy to ketamine
* Adult patients with an allergy to Midazolam
* Individuals with a history of mania/hypomania or diagnosis of of bipolar disorder
* Patients on lithium and/or lamotrigine therapy
* Recent or current homicidal ideation with an intent to act
* MDD with psychotic features or current or past diagnosis of a psychotic disorder
* No substance use disorder in the preceding 3 months except nicotine or caffeine or a positive urine screen for substances (except cannabis)
* Diagnosis of obsessive-compulsive disorder, antisocial personality disorder, borderline personality disorder, posttraumatic stress disorder, intellectual disability, altered mental status, pregnant or breastfeeding patients,
* Patients on \> 2 medications for hypertension
* Patients with uncontrolled hypertension (BP \>140 mm Hg systolic and/or \>90 mm Hg diastolic on two separate readings at the time of screening)
* Body weight of \> 150kg
* Patients with history of congestive cardiac failure
* Day of presentation, patients with unstable vital signs (systolic blood pressure \<90 or\>160 mm Hg, pulse rate \<50 or \>150 beats/min, and respiration rate \<10 or \>30 breaths/min)
* Consumption of opioids within 24 hours of drug administration
* Acutely intoxicated patients will also be excluded
Safety of the EnvPro HIV Vaccine in Healthy Volunteers

The purpose of this study is to determine the safety of a new HIV vaccine. The vaccine in this study is mixed with a chemical called alum to improve the body's response to the vaccine. Healthy adults who are not infected with HIV may participate in the study.

EnvPro is a recombinant, purified envelope protein vaccine with an aluminum hydroxide (alum) adjuvant. Aluminum hydroxide is licensed as an adjuvant in other vaccines, such as the hepatitis B vaccine. This study will examine the safety and tolerability of EnvPro with alum adjuvant in healthy, HIV uninfected adults.

All participants in this study will receive vaccine injections in the upper arm muscle. Participants will receive a second vaccine injection eight weeks after the first injection. Blood tests will be performed at study visits before the vaccine is given, during the eight weeks between injections, and at selected times for up to three years after the vaccine is given.

Eligibility Criteria:
Inclusion Criteria:

* HIV uninfected
* Normal medical history and physical exam
* Normal complete blood count
* Normal liver function
* Normal renal function
* Normal serum creatine phosphokinase (CPK)
* Availability for at least 1 year follow-up

Exclusion Criteria:

* History of immunosuppressive illness, chronic illness, or use of any immunosuppressive medications
* Medical or psychiatric condition or occupational responsibilities which preclude compliance with the study
* Live attenuated vaccines within 60 days of study entry
* Use of experimental agents within 30 days of study entry
Comparison of Dual-lumen Catheter-guided Mini-forceps Biopsy and Brush Cytology with Vacuum Aspiration in Suspicious Biliary Strictures

In this randomized crossover trial involving patients with indeterminate biliary strictures, we aimed to compare the diagnostic performance of the dual-lumen catheter-guided miniforceps biopsy (CMB) device with that of brush cytology under aspiration (BCA).


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18-88 years old.
* Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
* Biliary obstructive symptoms,or indeterminate biliary stricture suspected to be intrinsic based on prior imaging.

Exclusion Criteria:

* Any contraindications to ERCP.
* Severe cardiopulmonary disease or coagulopathy.
* Biliary strictures caused by extrinsic compression.
* Unwillingness or inability to provide consent.
* Pregnant or breastfeeding women.
Acupuncture for Women's Health Conditions

The purpose of this study is to evaluate the safety and effectiveness of acupuncture in treating women's health conditions.

This trial comprises three studies. In the first two studies, women will be randomly assigned to receive either real or sham acupuncture therapy. Study 1 will include women with various forms of cancer. White blood cell counts will be used to assess the effects of acupuncture on participants' immune responses. Study 2 will include women with unspecified pelvic pain and endometriosis; a self-report pain scale will be used to assess the effects of acupuncture on participants' symptoms. Study 3 will evaluate the validity and reliability of diagnoses made by Chinese medicine practitioners. In this study, a group of Chinese medicine practitioners will diagnose the same group of patients; consistency of the diagnoses will be evaluated.

Eligibility Criteria:
Inclusion Criteria for Study 1:

* Newly diagnosed ovarian cancer; primary peritoneal cancer; papillary serous cancer of the endometrium; or mixed mesodermal tumor of the uterus, ovary, or fallopian tube
* Currently undergoing chemotherapy
* Meet certain laboratory test requirements

Inclusion Criteria for Study 2:

Currently closed to recruitment

* Diagnosed with endometriosis or unspecified pelvic pain

Exclusion Criteria for Studies 1 and 2:

* Use of white blood cell boosters
* Prior radiotherapy with the exception of whole-breast irradiation for breast cancer
* Prior myelotoxic chemotherapy
* History of symptomatic cardiac or psychiatric disorder
* Use of a pacemaker
* Use of herbs or herbal supplements
* Prior use of acupuncture
* Enrollment in other research studies
Effect of Noninvasive Ventilation on Lung Function in Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis (ALS), or "Lou Gehrig's Disease", is a fatal disorder that causes progressive degeneration and weakening of the muscles of breathing, leading to breathing insufficiency and eventually breathing failure. This breathing insufficiency is commonly treated with a breathing assistance device, known as noninvasive positive pressure ventilation (NIPPV). While generally well tolerated and accepted, it is not clear whether or to what extent NIPPV in fact helps breathing function: some data suggest that NIPPV preserves breathing function over time, whereas other data suggest that it actually causes breathing function to decline more quickly. No studies have shown what the acute effect of NIPPV is on breathing muscle function in ALS patients.

This study will test the hypothesis that the acute use of NIPPV, at pressure levels that are in common clinical use, will cause measurable changes in tests of breathing function, compared to baseline and to lower levels of NIPPV. We expect that the results of this study will help to clarify whether and to what extent NIPPV assists respiratory muscle function in patients with ALS.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of amyotrophic lateral sclerosis
* clinical indication to start noninvasive ventilation (forced vital capacity \< 50% predicted or signs/symptoms of respiratory insufficiency)
* age 18 to 80 years old

Exclusion Criteria:

* prior institution of NIPPV
* inability to safely use NIPPV
* indications for tracheostomy assisted ventilation because of inability to clear secretions from the airway
* inability or unwillingness to perform pulmonary function testing
* presence of advanced dementia.
Multimodal Haptic Feedback for Plantar Sensory Substitution

The study will explore the use of a haptic device for sensory substitution in individuals with a movement disorder that has caused loss of plantar sensation. The haptic device consists of two components. The first element is a flexible insole with embedded pressure-sensing elements that transmit the spatial patterns of applied foot pressure over time. The second element is a haptic receiver with embedded actuators that vibrate or heat up in proportion to the transmitted pressure patterns, thus substituting the patient's lost plantar sensation.

OBJECTIVES:

1. Identify a systematic, methodical approach to determine whether different users of our haptic device can perceive and use vibrational and thermal feedback in order to correct their posture in real-time.
2. Evaluate whether a haptic device can be used to guide users to maintain a prescribed pattern of pressure on their feet during standing and walking.
3. Investigate whether a haptic device can improve outcomes on motor evaluation tasks.

Eligibility Criteria:
Inclusion Criteria:

* Able to ambulate 10 meters with or without assistance
* Able and willing to give written consent and comply with study procedures

Exclusion Criteria:

* Unable to give written consent or comply with study procedures
* Unable to perceive unsafe levels of heat in relevant areas
* Has a motor complete spinal cord injury
* Have transfemoral (above knee) amputation
* Any condition that would prevent the safe completion of study activities, as determined by the Principal Investigator
Carotid Atherosclerosis: MEtformin for Insulin ResistAnce Study

Hypothesis: Treatment with metformin in overweight non-diabetic individuals with coronary heart disease and on standard cardiovascular risk reducing agents including statins will have a beneficial impact on carotid artery atherosclerosis compared to placebo.

Rationale: Once subjects have a heart attack, they remain at much higher than average risk of another heart attack and stroke, despite the best current therapies to lower their cholesterol and blood pressure and thin their blood. Many subjects with heart disease also have problems metabolising (i.e. processing) sugar even if they do not have diabetes. There is some evidence that metformin, a drug which improves sugar metabolism, decreases the risk of future heart attacks in diabetic patients. However, whether metformin further reduces the risk of heart disease beyond established treatments in people without diabetes is unknown.

Method: The investigators will test the ability metformin, a drug with proven safety, to slow the progression of furring up (known as atherosclerosis) of blood vessels in non-diabetic subjects with heart disease. This will be achieved by treating 2 groups of subjects with metformin and placebo pills respectively. To measure atherosclerosis, the investigators will carry out ultrasound scans of the big blood vessels in the neck at the start of the study, after 1 year and after 1.5 years of therapy.The investigators will then be able to assess whether metformin has had a beneficial impact.


Eligibility Criteria:
Inclusion Criteria:

* Proven coronary heart disease (prior acute coronary syndrome, prior CABG or angiographically proven CHD)
* Aged 35-75 years
* Elevated waist circumference as per the International Diabetes Foundation criteria (94 cm in men and 80 cm in women)
* All patients will be on statin

Exclusion Criteria:

* Pregnancy and/or lactation at screening
* Premenopausal woman not on contraception
* Known or newly diagnosed diabetes mellitus on oral glucose tolerance testing (OGTT will be performed on subjects with HbA1C 6.0-6.9% and fasting plasma glucose \[FPG\] \< 7.0 mmol/L at screening18)
* Screening results: HbA1C ≥ 7.0% and/or fasting plasma glucose ≥ 7.0 mmol/L
* Patients with Acute Coronary Syndrome within the last 3 months
* Clinically unstable heart failure
* Uncontrolled angina
* Contraindications to metformin
Immune Durability After VSV-EBOV Vaccination

This prospective observational cohort study will follow the roughly 100 adults who received the VSV-ZEBOV vaccine in the Geneva phase 1 randomized controlled trial in 2014-2015 in order to determine their long-term (5-year) immune response to vaccination.

Background: During the Ebola epidemic of 2014-5, there was no proven therapy or prevention available beyond horizontal infection control measures. After the Canadian government donated 800 vials of the vaccine candidate VSV-EBOV to World Health Organization (WHO), the University Hospitals of Geneva agreed to perform a WHO-coordinated phase I/II double-blind, placebo-controlled randomized trial to assess the candidate's safety and immunogenicity healthy adult volunteers. The doses of 10 E7 pfu and 5 x 10 E7 pfu were tested in 35 and 16 volunteers, respectively, before a safety-driven study hold in late 2014. At trial resumption in early 2015, the remaining volunteers (n=51) received 3 x 10 E5 pfu. Thirteen volunteers received placebo. Among vaccinees, early immune responses were impressive, even at the lowest dose of 3 x 10 E5 pfu, and persisted well up to 6 months (last time point assessed). The trial successfully ended 12 months after injection. This prospective observational study will assess immune durability in this group of vaccinees at yearly time points up to five years post-vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Participated and was vaccinated with a single injection of VSV-EBOV at a dose of either 3 x 10E5 pfu, 10E7 pfu or 5 x 10E7 pfu in the Geneva phase I VSV-EBOV vaccine trial (NCT02287480).
* Able to provide written, informed consent for this observational study.

Exclusion Criteria:

* Received additional vaccination with VSV-EBOV at similar or differing doses.
* Was lost to follow-up in the Geneva phase I VSV-EBOV vaccine trial
A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)

This study will investigate different donanemab dosing regimens and their effect on the frequency and severity of ARIA-E in adults with early symptomatic Alzheimer's disease (AD) and explore participant characteristics that might predict risk of ARIA.


Eligibility Criteria:
Inclusion Criteria:

* Gradual and progressive change in memory function reported by the participant or informant for ≥6 months.
* A mini mental state examination (MMSE) score of 20 to 28 (inclusive) at screening.
* Have an amyloid PET scan result from central read, consistent with the presence of amyloid pathology.

Exclusion Criteria:

* Have significant neurological disease affecting the central nervous system other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson's disease, multiple concussions, or epilepsy or recurrent seizures, except febrile childhood seizures.
* Has current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in this study.
* A life expectancy of \<24 months.
* Have a presence or history of malignant neoplasms within the past 5 years prior to Visit 1.

Exceptions:

* non-metastatic basal- or squamous-cell skin cancer
* Stage 0 non-invasive carcinoma of the cervix
* Stage 0 non-invasive prostate cancer, or
* other cancers with low risk of recurrence or spread

  * Contraindication to MRI or PET scans
  * Have had prior treatment with a passive anti-amyloid immunotherapy.
Perineuraxial Anesthesia Fluid Management and Infant Neurobehaviors

Early change in neurobehavior is strongly associated with the intelligence development of children. Previous studies reported that cesarean section itself could influence the later development of children. In addition, neuraxial anesthesia including epidural, spinal and combined spinal epidural anesthesia (CSEA) are the major forms used during cesarean delivery, and these anesthesia techniques will undoubtedly evoke hypotension and corresponding hemodynamic alteration, of which would result in decreasing in umbilical placental insufficiency and fetus hypoxia leading to early abnormality of neurobehaviors in infants. Fluid management, such as crystalloid and colloid, is the common ones given before or / and after neuraxial anesthesia to prevent or reverse hypotension. However, it is still unknown whether the perineuraxial anesthesia fluid resuscitation could improve the neurobehavior scorings, and could produce positive effect on later intelligence development. Herein the investigators hypothesized that effective perineuraxial anesthesia fluid management during cesarean section would prevent the occurrence of hypotension and improve infant's neurobehavior scorings.


Eligibility Criteria:
Inclusion Criteria:

* 21-40 yr
* First time of delivery
* ASA status I-II
* No premature
* No genetic and infectious diseases
* Chinese

Exclusion Criteria:

* \< 21 yr
* \> 40 yr
* Subjects with cardiac and pulmonary disorders
* Dislocation of placenta
* Pregnant hypertension
* Allergy to local anesthetics
* Unwilling to cooperation
* With significant delivery side effects
Efficacy and Safety of LEO 152020 Tablets for the Treatment of Adults With Moderate to Severe Atopic Dermatitis

This is an up to 22-week clinical study in adult participants with moderate to severe atopic dermatitis (AD).

The purpose of the study is to test a new tablet (LEO 152020) to see if it improves AD and what the side effects are when compared with a placebo tablet with no medical ingredient.

During the study, there will be a 16-week treatment period during which the participants will be asked to take the tablets. The participants will regularly visit the clinic for tests and the study doctor will evaluate their AD. The participants will also be asked to answer questions about their AD symptoms, itch, sleep, and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Adult, age 18 years or older at screening.
* Diagnosis of chronic atopic dermatitis (AD).
* History of AD ≥1 year prior to baseline.
* Recent (within 6 months prior to baseline) documented history of inadequate response to topical AD treatments or subject for whom topical AD treatments are medically inadvisable.
* 7.1≤ Eczema Area and Severity Index (EASI) ≤50 at baseline.
* Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score ≥3 at baseline.

Exclusion Criteria:

* Previous treatment with an oral histidine 4 receptor (H4R) antagonist (including LEO 152020) within 6 months prior to baseline.
* Previous treatment with 3 or more systemic AD treatments prior to screening.
* Women who are pregnant, intend to become pregnant, or are lactating.