cyrilzakka/clinical-trials huggingface dataset:
Response of Preterm Infants to Multisensory Stimuli

The aim of this study is to measure the variation of oxytocin and cortisol levels in the saliva of premature neonates and their mother after sensorial stimuli.

The aim of this study is to measure the variation of oxytocin and cortisol levels in the saliva of neonates with gestational age ranging from 32 to 34 completed weeks and in the saliva of their mothers. The measurements are taken before and after sensorial stimuli including mother voice exposure +/- tactile distraction for 10 minutes. The two interventions are performed between day 5 and day 12 after birth and 24 to 48 hours apart. Each child is randomised in a group depending on order of the two interventions.

Investigators hypothesize that an increase in the oxytocin/cortisol ratio will be occurred in neonates after hearing their mothers and that simultaneous tactile stimulation will mitigate that effect.

Concomitantly, the neonate's vital signs and his facial expressions are recorded during interventions. The mothers anxiety level is assessed PSS-NICU questionnaire given before the first and after the second intervention.

Eligibility Criteria:
Inclusion Criteria:

* Newborn gestational age 32 0/7 weeks to 34 6/7 weeks
* Born at university hospital Geneva
* French speaking parents
* Out of incubator
* Signed consent

Exclusion Criteria:

* Newborn with one of the above conditions:
* Congenital malformation
* intraventricular hemorrhage grade III or IV
* white matter abnormality
* anti-epileptic or sedative drugs
* altered consciousness level
* Infant requiring respiratory support
* psychiatric disorders in the mother or antenatal use of psychoactive drugs
* Bilateral absent otoacoustic emissions and/or auditory evoked potential
* Parents refusal to participate
Interest of Maintenance Chemotherapy After Induction Treatment for Inflammatory Breast Cancer

To evaluate the benefit of adding docetaxel-5 fluorouracile (D-5FU) regimen after pre-operative epirubicin-cyclophosphamide (EC) and loco-regional treatment in inflammatory breast cancer (IBC).


Eligibility Criteria:
Inclusion Criteria:

* histologically proven breast cancer
* inflammatory breast cancer
* no metastatic site
* age \> or = 18 and \< or = 60
* OMS score: 0, 1, 2
* life expectancy \> or = 3 months
* Normal (isotopic or ultrasonography) left ventricular ejection fraction
* Normal haematological, liver, and kidney functions
* patients who gave their written informed consent.

Exclusion Criteria:

* non inflammatory breast tumour with a cutaneous permeation nodule
* presence of a metastatic site
* medical history of a cancerous tumour except for carcinoma in situ of the uterine cervix, a basal cell skin cancer, or a breast carcinoma on the contralateral side
* patients having already had a chemotherapy, a radiotherapy, or an hormone therapy for this breast tumour
* medical history of congestive heart failure even medically controlled
* medical history of myocardial infarction during the 6 months before the inclusion in the study
* active infection or other severe underlying pathology which could possibly prevent the patient from receiving treatments
* administration of another chemotherapy during the study
* pregnant or breast feeding patients (the patients of childbearing age must be placed under efficient contraception)
* patients whose social or psychological state does not allow to consider a correct adherence to the treatment and to the required medical follow-up
* WHO score 3,4
* unbalanced diabetes
* polysorbate 80 allergy
The Effects of Manual and Automatic Lancets on Pain and Stress in Newborn Capillary Heel Blood Collection

Heel blood sampling is a routine but painful procedure for newborns. A limited number of international studies have shown that automatic lancets are more effective with less pain and tissue damage than manual lancets.

In line with this information, this study was planned to investigate the effects of manual and automatic lancets on pain and stress in newborn capillary heel blood collection.


Eligibility Criteria:
Inclusion Criteria:

* Postnatal age zero day
* Term newborn
* No congenital anomalies
* No advanced medical intervention at birth
* Infants not receiving oxygen or respiratory support

Exclusion Criteria:

* Legal guardian not giving consent to research
An Extended Feasibility Phase I/II Study of Methylenetetrahydrofolate (Arfolitixorin) and Pemetrexed Single Agent, Given as Neoadjuvant Treatment in Patients With Resectable Rectal Cancer

The purpose of this study is to determine whether an optimal dose of \[6R\] 5,10-methylenetetrahydrofolate (arfolitixorin) in combination with pemetrexed are effective in pre-operative treatment of patients with resectable rectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Pathological/ cytological diagnosis of adenocarcinoma of the rectum. Patients must have operable rectal cancer that is amenable to surgery.
* No prior therapy for rectal cancer
* Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1
* Adequate organ function
* Patient compliance and geographic proximity that allow adequate follow-up
* For women: Must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen during and for 3 months after treatment; must have a negative serum or urine pregnancy test and must not be lactating.
* For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 3 months after treatment.
* Estimated life expectancy of at least 12 weeks
* Signed informed consent
* At least 18 years of age

Exclusion Criteria:

* Concurrent administration of any other anti-tumor therapy.
* Treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
* Serious concomitant systemic disorders (e.g., active infection including HIV, cardiac disease) that in the opinion of the investigator would compromise the patient's ability to complete the study.
* Have previously completed or withdrawn from this study or any other study investigating pemetrexed.
* Are pregnant or breast-feeding.
* Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
* History of significant neurological or mental disorder, including seizures or dementia.
* Inability to interrupt aspirin or other nonsteroidal anto-inflammatory drugs (NSAIDs)
* Presence of clinically relevant third-space fluid collection that cannot be controlled by drainage or other procedures prior to study entry.
* Inability or unwillingness to be given 5,10-methylenetetrahydrofolate, vitamin B12 or dexamethasone.
Effect of BMS-914392 on Pharmacokinetics of Metoprolol

The purpose of the study is to assess the effects of BMS-914392 administration on the pharmacokinetics of a single-dose of metoprolol in healthy subjects.

Protocol designed to evaluate the potential for a drug-drug-interaction

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
* Subjects genotyped as Intermediate, Extensive or Ultra-rapid CYP2D6 metabolizers
* Women of childbearing potential (WOCBP) and men must be using an acceptable method of contraception to avoid pregnancy

Exclusion Criteria:

* Any significant acute or chronic medical illness.
* Current or recent (within 3 months of study drug administration) gastrointestinal disease.
* Current or history of neurological diseases or psychiatric disorders, cardiovascular diseases, and bronchospastic diseases.
* CYP2D6 poor metabolizers based on genotype
Study of NGM707 As Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies

Study of NGM707 as Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented locally advanced or metastatic solid tumor malignancy.
* Progressed or was intolerant to all available therapies known to confer clinical benefit appropriate for their tumor type, and for which the patient was eligible and willing to receive, or refused SOC treatments that are perceived to have marginal clinical benefit.
* Adequate bone marrow, kidney and liver function.
* Performance status of 0 or 1.
* Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade 1 except for AEs not constituting a safety risk by Investigator judgement.

Exclusion Criteria:

* Prior treatment targeting ILT2 and/or ILT4 or targeting HLA-G.
Prenatal Steroids for Treatment of Congenital Cystic Adenomatoid Malformations (CCAM)

Congenital cystic adenomatoid malformations (CCAMs) are theorized to be growing immature lung tissue. Administration of maternal steroids in the mid-trimester may stop the growth or decrease the size of the CCAM, thus increasing normal lung tissue and improving survival in fetuses with large CCAMs. This is a prospective, blinded, randomized trial comparing administration of a single course of antenatal steroids (Betamethasone) to control (i.e., placebo). The primary outcome variable will be incidence of hydrops. One month postnatal survival and relative size of the CCAM as determined by CCAM volume:head circumference ratio (CVR) between treatment/no treatment groups will be secondary outcome variables. Change in size of CCAM will be serially followed for both groups with individual growth curves being plotted prenatally and these will be compared with pathology weigh and volume to evaluate treatment effect. Other prenatal data collected will include: incidence of polyhydramnios, incidence of premature rupture of membranes, incidence of material complications. We will also compare mode of delivery, postnatal respiratory compromise, need for resection in the first week of life, and occurrence of complications during newborn administration


Eligibility Criteria:
Inclusion Criteria:

* GA \< 26 weeks
* Maternal age \> 18 years of age
* Singleton pregnancy
* Normal chromosomes
* CCAM volume to head circumference ratio (CVR) \> 1.4
* No maternal medical/surgical contraindications
* No evidence of hydrops
* Not previously randomization

Exclusion Criteria:

* Maternal diabetes or use of insulin
* Preterm labor
* Multiple congenital anomalies with CCAM
* Chromosomal anomaly with CCAM
* Multiple gestation pregnancy with CCAM
* Not willing to be randomized
* Unable or unwilling to return to UCSF for second dose of drug or placebo
* CVR \< 1.4
French National Registry of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator

National french registry of patients with tetralogy of Fallot and implantable cardioverter defibrillator.

Inclusion criteria:

* patient with tetralogy of Fallot \> 18 years
* implantable cardioverter defibrillator (ICD)
* primary or secondary prevention

All french centers performing ICD implantation are annually contacted to include all patients with tetralogy of Fallot and ICD.

Retrospective inclusion of cases before 2010 and prospective inclusion after 2010 with prospective follow up and annual update.

All events are centrally adjudicated with collection of all baseline ECG and reviewing of endocavitary EGM.

Eligibility Criteria:
Inclusion Criteria:

* tetralogy of Fallot
* implantable cardioverter defibrillator

Exclusion Criteria:

* age \< 18 years
Magnetic Resonance Imaging-Transrectal Ultrasound Fusion Image-Guided Prostate Biopsy Following Radical Prostatectomy in Patients With Prostate Cancer

This pilot clinical trial studies magnetic resonance imaging (MRI)-transrectal ultrasound (TRUS) fusion image-guided prostate biopsy following radical prostatectomy in patients with prostate cancer. Diagnostic procedures, such as MRI-TRUS fusion image-guided prostate biopsy may help find and diagnose prostate cancer

PRIMARY OBJECTIVES:

I. To evaluate accuracy of the new image-guided targeted needle biopsy using the ex-vivo human prostate as obtained from fresh radical prostatectomy specimens.

OUTLINE: Patients undergo robotic radical prostatectomy, followed by 3 MRI-TRUS fusion image-guided prostate biopsies.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have biopsy-proven prostate cancer, or prostate-specific antigen (PSA) \>= 4 ng/ml or an abnormal digital rectal examination (DRE) if consented before prostate biopsy
* Subjects must have at least 2, preferably 3, pre-operative magnetic resonance imaging (MRI)-identified malignant or benign lesions that measure between 10 mm and 15 mm in diameter within the prostate
* Subjects must have decided to have their prostate surgically removed

Exclusion Criteria:

* Patients who do not give informed consent
* Patients with extracapsular extension of their prostate cancer
Subgroups of Older Adults With Back Pain and Multiple Chronic Conditions

The overall goal of this study is to use the National Health and Aging Trends Study (NHATS) data to gain an understanding of how multiple chronic conditions impact the health outcomes of older adults with back pain.

This study seeks to gain knowledge regarding how multiple chronic conditions affect the health and function of older adults with back pain. The investigators will perform a retrospective cohort study using secondary analysis of the National Health and Aging Trends Study (NHATS) data. NHATS collected longitudinal data on Medicare beneficiaries over 65 for six years, from 2011-2017. This set of data is comprehensive and includes self-reported survey data as well as physical performance data, both of which this study will utilize.

The specific aims include to 1) Estimate the longitudinal associations of the number of chronic conditions, using a standard classification scheme, with long-term physical performance, function, and recurrent falls, 2) Identify specific combinations of chronic conditions that are most strongly associated with long-term physical performance, function, and recurrent falls, 3) Determine the association of the number and type of chronic conditions with rehabilitation service use. The investigator will test a corresponding hypothesis for each aim: 1) Medicare beneficiaries reporting back pain with a greater number of chronic conditions will have worse physical performance, lower functional status, and be more likely to experience recurrent falls over 6 years, 2) Medicare beneficiaries reporting back pain with common and potentially modifiable conditions of anxiety, depression, and arthritis (individually and combined as dyads or a triad) will have worse physical performance, lower functional capacity, and be more likely to experience recurrent falls over 6 years, 3) Medicare beneficiaries with back pain and multiple chronic conditions will report lower use of rehabilitation services in the past one year compared to those with back pain alone or one additional chronic condition.

Eligibility Criteria:
Inclusion Criteria:

* This study will include community-dwelling participants in the NHATS study who indicated that in the last month they had been bothered by pain in the last month and indicated that the site of pain was the lower back.

Exclusion Criteria:

* This study will exclude participants who are non-ambulatory (requires wheelchair or scooter).
Comparative Efficacy of Lipid Based Artificial Tears vs Aqueous Based Artificial Tears in Managing EDE

This randomized clinical trial aims to compare the efficacy of lipid-based (Recuro) versus aqueous-based (Softeal) artificial tears in managing Evaporative Dry Eye (EDE) over six weeks. Conducted in a hospital or ophthalmology clinic, the study includes 60 participants (aged 18-55, both genders) diagnosed with EDE.

Participants are randomly assigned to receive either lipid-based or aqueous-based artificial tears, following a block randomization method (block size of 4) generated using Research Randomizer. The primary objectives are to assess symptom reduction and improvement in quality of life, measured by the Ocular Surface Disease Index (OSDI) and the SANDE questionnaire. Objective assessments include tear film stability, Meibomian gland function, tear volume, and ocular surface health.

Eligibility Criteria:
Inclusion Criteria:

* Adults (both genders) aged 18-55 years diagnosed with evaporative dry eye (EDE).
* Willingness to adhere to the prescribed treatment regimen (lipid-based or aqueous-based artificial tears).
* Include patients with a history of dry eye symptoms for at least 1-3 months.
* Ocular Surface Disease Index (OSDI) score ≥13, indicating the presence of mild to severe dry eye symptoms.
* Patients with tear break-up time (TBUT) \<10 seconds, indicating tear film instability.(16)

Exclusion Criteria:

* Use of any topical ophthalmic medications (e.g., lubricants, anti-inflammatory drugs, or cyclosporine) for dry eye within the last 1 month.
* Active ocular infection or inflammation (e.g., conjunctivitis, uveitis).
* History of ocular surgery or trauma within the past 6 months.
* Participants currently wearing contact lenses or those who have worn contact lenses in the past three months.
* Systemic conditions known to impact ocular surface health, such as uncontrolled diabetes, autoimmune disorders, or Sjögren's syndrome.
Ultrasound-Guided Internal Superior Laryngeal Nerve Block for Double-Lumen Bronchial Tube

investigate the effectiveness and safety of ultrasound-guided bilateral internal branch of the SLN (iSLN) block for alleviating POST immediately after the operation.


Eligibility Criteria:
Inclusion Criteria:

* ASA 1 to 3

Exclusion Criteria:

* patients who did not provide consent
* with a pre-existing sore throat, hoarseness and upper respiratory tract infection
* tracheal pathology, tracheostomy
* a history of psychosis, diabetes and thyroid, oral cavity or pharynx surgery
* known or suspected allergy to ropivacaine
* chronic opioid use
* use of nonsteroidal anti-inflammatory drug medication within 24 hours
* known or suspected difficult airway
* patients who will be supported by tube ventilator after the operation.
Vegan and Omnivorous Diets and Skeletal Muscle Turnover in Healthy Older Adults

Dietary protein intake and physical activity are key to minimise the age-related loss of skeletal muscle mass. While animal-derived protein sources are considered high-quality anabolic foods, it remains unclear whether non-animal-derived (vegan) protein sources support skeletal muscle maintenance and healthy ageing. The aim of the present study is to assess the effect of a vegan diet on daily muscle protein synthesis rates compared to a protein-matched omnivorous diet where the majority of protein is derived from high-quality animal-based protein sources.

Background: The age-related loss of muscle mass and strength is (partly) explained by a blunted responsiveness of skeletal muscle to the anabolic properties of dietary protein and muscle contraction. Therefore, sufficient dietary protein intake and physical activity are required to minimise age-related muscle atrophy. It remains unknown whether this can be achieved utilising non-animal-derived (vegan) protein sources.

Objective: To assess daily muscle protein synthesis rates when adopting a vegan or protein-matched omnivorous control diet.

Methods: Healthy older adults (aged 60-80 years) will be randomly allocated to a completely controlled 1-week vegan (providing 0.8 g/kg BW/day protein) or protein-matched omnivorous diet. During this week, participants will perform a set of unilateral leg resistance exercise on day 1, 3, and 5. Deuterium oxide in combination with saliva and muscle sample (from the m. vastus lateralis) collection will be used to measure daily muscle protein synthesis rates in resting and exercised tissue.

Value: This will be the first study assessing daily muscle protein turnover in healthy older adults adopting a 1-week vegan diet. This will contribute to the understanding and viability of vegan protein to support active and healthy ageing.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 18.5 - 30
* Active (not very sedentary and not master athlete; assessed via IPAQ)
* Women only: post menopause

Exclusion Criteria:

* Hypertension (\>150/90 mmHg)
* Any diagnosed metabolic impairment
* Any diagnosed cardiovascular disease
* Any diagnosed gastrointestinal disease
* Diagnosed cancer
* Any medication known to affect muscle metabolism (e.g. hormone replacement therapy)
* Severe food allergies or intolerances (e.g. celiac, lactose intolerance, allergic to fungi or algae foods)
* Smoking
Active Surveillance for Limited GGNs

This study is a single-arm, multi-center, phase III trial conducted under the Eastern Cooperative Thoracic Oncoloy Project (ECTOP) . The primary objective of the study is to assess the 5-year overall survival of patients with one or two ground-glass opacities by employing an active surveillance approach rather than immediate surgical resection.

The trial aims to confirm the hypotheses that delaying surgery until GGO nodules exhibit progression or meet certain criteria offers a prognosis equivalent to those undergoing immediate surgical resection, potentially allowing many of these patients to avoid surgery altogether.

Eligibility Criteria:
Patients eligible for enrollment in the study are required to meet all the following criteria.

1. Demonstrates the following on thin-section computed tomography (TSCT) scan:

   1. Presence of one or two GGNs (bilateral lesions are permitted).
   2. All lesions have remained stable without regression or enlargement for at least 3 months.
   3. The dominant lesion (the lesion with the largest maximum tumor diameter) has a maximum tumor diameter ≥0.6cm and ≤2cm.
   4. CTR ≤0.25 in lesions.
   5. No lymph node with a diameter \>1cm in the mediastinal view.
   6. Not adjacent to the pleura in dominant lesion and no sign of pleural retraction in any lesions.
2. Has not previously undergo any anti-tumor drug or radiation therapy for the lung lesions.
3. Aged 18-75 years.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
5. Written informed consent.

Patients will be excluded if they meet any of the following criteria.

1. History of any prior malignancies within the past 5 years.
2. History of lung surgery.
3. History of interstitial pneumonia, pulmonary fibrosis or other severe pulmonary diseases.
4. Presence of severe or uncontrolled diseases that may possibly reduce the 10-year life expectancy.