cyrilzakka/clinical-trials huggingface dataset:
Food Rheology and Feeding in Lean and Obese Humans

The 2010 National Health Objectives call for a reduction in the prevalence of obesity. The marked recent increase in overweight and obesity prevalence implicates behavioral factors in the etiology of the epidemic. The present proposal hypothesizes the trend is attributal, in part, to increasing consumption of energy-yeilding beverages since they are a significant and increasing source of dietarty energy and they elicit weaker appetitive and dietary responses than solid foods.

Three human studies are propsed to more fully characterized attributes of liquids and solids that may account for the differential appetitive responses they elicit, potential contributory mechanisms as well as the dietary implications of their consumption. Study 1 will contrast the acute effects of fluid and solid foods varying in macronutrient content on satiation, satiety and feeding. Study 2 will determine if the pattern of fluid and solid ingestion influences satiety and feeding by monitoring appetitive and dietary responses to energy and macronutrient matched fluid and solid loads ingested as meal components or between meal snacks. To better assess the clinical implications ofdiets incorpprating liquid or solid supplements. Study 3 will entail chronic ingestion of matched energy yeilding fluid or solid loads with concurrent measurement of appetite, dietary intake, energy expenditureand body weight/composition.

Eligibility Criteria:
Inclusion Criteria:

* BMI 18-23 or 27-35
* weight stable
* constant habitual activity pattern
* low fruit/vegetable consumer
* non-restrained eater

Exclusion Criteria:

* diabetic
* taking medication known to influence appetite
Fluvoxamine to Augment Olfactory Recovery For Long COVID-19 Parosmia

This study will investigate the efficacy of oral fluvoxamine in olfactory improvement following Covid-19- associated parosmia. This is a randomized, double-blinded, placebo-controlled trial.

The drug will be given over a 14 weeks with six weeks titrating up, six weeks maintaining highest dose, and up to two weeks tapering down. Assessments will be collected following week 12 to measure change in olfactory function from baseline between the two study groups.

Eligibility Criteria:
Inclusion Criteria:

* Men and women between the ages 18 to 70 years
* Residing within the states of Missouri or Illinois
* Complaints of odors of certain things or everything are distorted
* Olfactory dysfunction that has persisted for \>2 months after suspected COVID-19 infection
* Ability to read, write, and understand English

Exclusion Criteria:

* History of olfactory dysfunction prior to COVID-19 infection
* Any use of concomitant therapies specifically for the treatment of olfactory dysfunction
* History of olfactory dysfunction of longer than 12 months
* History of bipolar disorder as SSRIs can theoretically destabilize bipolar disorder
* Participants with symptoms of depression as evidenced by a score of 10 or greater on the Patient Health Questionnaire-9 (PHQ-9).95 The PHQ-9 is a nine-item questionnaire designed to assess and aid in diagnosing patients with depression in clinical and community settings.
* History of neurodegenerative disease (i.e., Alzheimer's dementia, Parkinson's disease, Lewy body dementia, frontotemporal dementia)
* History of chronic rhinosinusitis or sinus surgery
* Pregnant or breastfeeding mothers.
* Already enrolled in another COVID 19 medication trial or receipt of monoclonal antibody infusion.
* Taking donepezil or fluoxetine (rationale: these drugs are S1R agonists) or sertraline (a S1R antagonist).
* Participants taking theophylline, tizanidine, clozapine, or olanzapine (drugs with a narrow therapeutic index that are primarily metabolized by CYP 1A2, which is inhibited by fluvoxamine.
* Taking another SSRI, unless at a low dose (e.g., escitalopram 5mg) such that adding fluvoxamine would not put patient at risk for serotonin syndrome.
* Taking coumadin based on theoretical risk of increased bleeding with fluvoxamine.
* Unable to provide informed consent.
* Unable to perform the study procedures.
International Multicentric Study ARON-1

The ARON-1 Study is designed as an International Multicentric Retrospective Study to collect global experiences with the use of immuno-combinations in patients with metastatic RCC.

Two Supplementary Studies (ARON-1α and ARON-1β) have been designed. The ARON-1α Supplementary Study has been designed to investigate for the presence of genomic signatures from tumor samples of patients treated with first-line immuno-combinations for advanced RCC. The ARON-1β Supplementary Study has been designed to charaterize the immune cell populations and assess their relationship with the clinical outcome of mRCC patients treated with first-line immuno-combinations


Eligibility Criteria:
Inclusion Criteria:

* Patients aged \>18y
* Cytological or Histologically confirmed diagnosis of clear cell or non-clear cell RCC
* Histologically or radiologically confirmed diagnosis of metastatic disease
* First-line treatment with nivolumab plus ipilimumab or nivolumab plus cabozantinib or pembrolizumab plus axitinib or pembrolizumab plus lenvatinib or avelumab plus axitinib or atezolizumab plus bevacizumab

Exclusion Criteria:

* Patients without histologically confirmed diagnosis of RCC
* Patients without histologically or radiologically confirmed metastatic disease
* Patients treated with immuno-combinations not included in the list reported in the Inclusion Criteria Section
Observational Monocentric Study on Biliary Tract Cancer (BABEL)

BABEL is an observational, single-center, prospective study about patients affected by biliary tract cancers (BTC) treated at the Medical Oncology Unit of the FPUAG - IRCCS.

BABEL is an observational, single-center, prospective study with an historical cohort. Study population is represented by patients affected by biliary tract cancers (BTC) treated at the Medical Oncology Unit of the FPUAG - IRCCS. The study involves an historical cohort and a prospective cohort. Primary aim of the study is to associate BTC patients' overall survival with IDH1/2 mutations, in order to confirm the prognostic role of these genes both metastatic and resectable disease setting. The secondary aims are to correlate FGFR mutations and overall survival of BTC patients and to find new clinical and molecular characteristics linked with survival and response to treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with biliary tract cancer;
* Patients with radiological evident disease;
* Patients \>18 anni;
* Written informed consent;
* Patients with at least one oncological visit.

Exclusion Criteria:

* Patients without available clinical data;
* Patients without histological diagnosis of BTC;
* Patients without written informed consent.
Galileo-Hip Whole Body Vibration /Conventional Physiotherapy /Coxarthrosis

Osteoarthritis (OA) is the most common degenerative arthropathy. Load-bearing joints such as knee and hip are more often affected than spine or hands. The prevalence of gonarthrosis is generally higher than that of coxarthrosis.

Because no cure for OA exists, the main emphasis of therapy is analgesic treatment through either mobility or medication. Non-pharmacologic treatment is the first step, followed by the addition of analgesic medication, and ultimately by surgery.

The goal of non-pharmacologic and non-invasive therapy is to improve neuromuscular function, which in turn both prevents formation of and delays progression of OA. A modification of conventional physiotherapy, whole body vibration has been successfully employed for several years. Since its introduction, this therapy is in wide use at our facility not only for gonarthrosis, but also coxarthrosis and other diseases leading to muscular imbalance.

This study is a randomized, therapy-controlled trial in a primary care setting at a university hospital. Patients presenting to our outpatient clinic with initial symptoms of coxarthrosis will be assessed against inclusion and exclusion criteria. After patient consent, 6 weeks of treatment will ensue. During the six weeks of treatment, patients will receive one of two treatments, conventional physiotherapy or whole-body-vibration exercises of one hour three times a week. Follow-up examinations will be performed immediately after treatment and after another 6 and 20 weeks, for a total study duration of 6 months. 20 patients will be included in each therapy group.

Eligibility Criteria:
Inclusion Criteria:

* Age 30 - 80 years
* Body weight less than or equal to 160 kg
* Body-Mass-Index less than 40 kg/m²
* Outpatient
* Legal competence
* Signed informed consent
* Uni- or bilateral Coxarthrosis according to ACR criteria
* WOMAC-pain index (visual analogue scale) of 30-70 mm
* Coxarthrosis stage II-III according to Kellgren and Lawrence

Exclusion Criteria:

* Participation in parallel interventional studies
* Bilateral Coxarthrosis with WOMAC Pain index more than 70 mm
* Previous surgery during the past 6 months at the Index Joint
* Injury of the study joint during the last 6 months
* Secondary rheumatoid or septic arthrosis or systemic diseases affecting the study joint
* Activated coxarthrosis with intraarticular effusion
* Body weight \> 160 kg or body mass index \> 40 kg/m²
* Analgesic therapy with steroidal drugs
* Physiotherapy of the lower extremities during the past 6 weeks
* Existing endoprosthetics in the lower extremities
Life Quality Determinant Assessment of Fibromyalgia Patients

The primary purpose is the evaluation of life quality of Fibromyalgia patients. The investigators' main hypothesis includes the role of geographical, sociological, psychological and physical activity on life quality.


Eligibility Criteria:
Inclusion criteria:

* Age group : 20 to 60
* Male or female
* American College of Rheumatology criteria
* Social Security beneficiary
* Informed consent of the patient
* Patient informed of the medical examination prior to inclusion
* Patient residing in the Bas-Rhin area

Exclusion Criteria:

* No medical objections to performing a stress test
* Any cardio-respiratory and musculoskeletal affection preventing physical activity
* Any particular clinical form disease
* Patient in situation of exclusion
* Subject incapacity to understand informed consent
* Patient deprived of freedom or under the protection of a conservator
* Pregnancy or breast-feeding
Sustained Lung Inflation in Preterm Infants

This is a randomized controlled study to investigate the effect of application of sustained lung inflation (SLI) at birth on the respiratory outcome of preterm infants with respiratory distress syndrome.

Enrolled infants (n=160) were randomized before birth into 2 groups (intervention and control group) in a ratio 1:1. Randomization was done through an online randomizer (www.graphpad.com), and sealed envelopes were used to assign the infant to one of the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age ≥ 27 weeks and ≤ 32 weeks
* Appropriate for gestational age
* Weight \>800 grams

Exclusion Criteria:

* Major congenital anomalies (congenital heart, cerebral, lung or abdominal malformations)
* Fetal hydrops
Near Infrared Photobiomodulation Treatment for Diabetic Macular Oedema

This pilot study aims to establish that treatment with near infrared light (NIR) reduces diabetic macular oedema in patients suffering diabetic retinopathy by exerting a positive beneficial effect at retinal cellular level.

This pilot study aims to establish that treatment with near infrared light (NIR) reduces diabetic macular oedema in patients suffering diabetic retinopathy by exerting a positive beneficial effect at retinal cellular level.

Diabetic retinopathy is a common cause of severe loss of vision and the most common cause of blindness in individuals between the ages of 20 and 65 years in developed countries.Swelling of the central retina or "macular oedema". Patients will be treated in an office clinic,three times a week for a treatment duration of 2 minutes per session, a total of 12 times over the duration of 4 weeks and will be assessed at 8 weeks to establish any change induced in retinal oedema. Safety follow up will be assessed at 3 and 6 months post treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Diabetic Macular Oedema with centre involving thickness of \>300µm
2. Age \>= 18 years
3. Diagnosis of diabetes mellitus
4. Best corrected visual acuity of 6/9 to 6/60 (letters 77- 33)
5. Intraocular pressure 6 to 25 mmHg
6. Written informed consent has been obtained.

Exclusion Criteria:a) Known allergy to agents used in the study eg. fluorescein b) Women who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using reliable means of contraception. A woman is considered of childbearing potential unless she is postmenopausal and without menses for 12 months or is surgically sterilised c) Loss of vision due to other causes (e.g. age related macular degeneration, myopic macular degeneration, retinal vein occlusion) d) Macular oedema due to other causes e) An ocular condition that would prevent visual acuity improvement despite resolution of oedema (such as foveal atrophy or substantial premacular fibrosis) f) Treatment with intravitreal triamcinolone acetonide (IVTA) within the last 6 months or peribulbar triamcinolone within the last 3 months, or anti vascular endothelial growth factor (VEGF) drugs: ranibizumab and aflibercept, within the last 2 months.

g) Cataract surgery within the last 3 months h) Retinal laser treatment within the last 4 months i) Media opacity including cataract that already precludes adequate macular photography or cataract that is likely to require surgery within 6 months j) Intercurrent severe disease such as septicaemia, any condition which would affect follow-up or photographic documentation (e.g. geographical, psycho-social) k) History of chronic renal failure requiring dialysis or renal transplant l) Blood pressure \>180/100 m) Patient has a condition or is in a situation that in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study

-
Study of Enteric-coated Mycophenolate Sodium (EC-MPS) With Cyclosporine Microemulsion and Steroids in Pediatric de Novo Renal Transplant Patients

The aim of this pilot study is to evaluate efficacy and tolerability of EC-MPS b.i.d, with Cyclosporine microemulsion and steroids in pediatric de novo renal transplant patients. Safety and doses variations are also evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Recipients of a primary renal transplantation
* Recipients of a renal transplantation only

Exclusion Criteria:

* Recipients of a multi-organ transplantation
* Unable to take an oral medication
* Requiring an induction therapy with polyclonal, monoclonal antibodies (OKT3, ATG, ALG).

Other protocol-defined inclusion / exclusion criteria may apply
Study of Adalimumab in Participants With Peripheral Spondyloarthritis (SpA)

The objective of this study was to evaluate the efficacy and safety of adalimumab 40 mg administered every other week (eow) subcutaneously (SC) compared to placebo for 12 weeks followed by open label (OL) safety and efficacy assessments in participants with non-ankylosing spondylitis (AS), non-psoriatic arthritis (PsA) active peripheral spondyloarthritis (SpA) who have had an inadequate response to \>= 2 non-steroidal anti-inflammatory drugs (NSAIDs), or are intolerant to, or have a contraindication for, NSAIDs.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants who had inadequate response to \>= 2 non-steroidal anti-inflammatories (NSAIDs)
* Participants who had arthritis or enthesitis or dactylitis plus: met spondyloarthritis clinical criteria
* Negative purified protein derivative (PPD) test and Chest X-Ray performed at Baseline Visit were Negative
* Ability to administer subcutaneous injections
* General good health

Exclusion Criteria:

* Prior anti-tumor necrosis factor (TNF) therapy
* Psoriasis or Psoriatic Arthritis
* Fulfillment of modified New York criteria for Ankylosing Spondylitis
* Recent infection requiring treatment
* Significant medical events or conditions that had put patients at risk for participation
* Female participants who were pregnant or breast-feeding or considering becoming pregnant during the study
* History of cancer, except successfully treated skin cancer
* Recent history of drug or alcohol abuse
OurSleepKit to Support CPAP Adherence

The goal of this clinical trial is to learn if a couple-focused mobile health intervention will improve the use of continuous positive airway pressure (CPAP), the primary treatment option for obstructive sleep apnea (OSA). Participants include newly diagnosed patients with OSA who are candidates for CPAP treatment and their partners. The couples will received supportive information and resources on their mobile devices before CPAP begins and continuing for 6 months into CPAP treatment. Their interaction with the resources is self-paced and the time sent engaging with the information is up to them. Participants will be asked to answer questions independently at five points: before CPAP, and after using CPAP for 1-week, 1-month, 3-months and 6-months. Those questions are about their experience of using CPAP, how the partner is involved in CPAP treatment, and symptoms and quality of life. At the end of the study, some couples may be contacted for a virtual discussion about your experience regarding study participation which lasts approximately 1 hour.


Eligibility Criteria:
Inclusion Criteria:

* patients should be males or females (age≥18 years) with diagnosed OSA and candidates for CPAP therapy (with any type of pressure delivery mode), and are cohabiting with their partner for at least one year
* The partners of eligible patients will be recruited if they are not diagnosed with OSA and not using CPAP
* both partners should have their own mobile devices with access to the internet

Exclusion Criteria:

* have a diagnosis of a sleep disorder other than OSA based on a polysomnogram (e.g., central sleep apnea, narcolepsy, or periodic limb movement disorder)
* have planned bariatric surgery (as they typically quit CPAP after surgery)
* have a partner using CPAP
* are pregnant because the changes in respiration and sleep quality occurring with pregnancy may confound the results.
* couples with one or both partners doing regular overnight shift work or those unable to speak or write in English will be excluded.
Short Versus Standard Post-operative Stay After Elective Cesarean Delivery

After major open abdominal surgery, transient paralytic ileus usually follows. It has been suggested that stimulation of pain fibers, excessive sympathetic tone, and the release of inhibitory neurotransmitters from bowel wall associated with bowel manipulation and peritoneal irritation are responsible mechanisms. There have been concerns that early postoperative oral feeding would lead to vomiting with subsequent aspiration pneumonia, anastomotic leakage, and wound dehiscence.


Eligibility Criteria:
Inclusion Criteria:

1. Women is sure of her last menstrual period or documented early pregnancy ultrasound.
2. Women aged 20-35 years.
3. Women with Body mass index18-22 kg/m2.
4. Estimated gestational age is ranging between 37-40 weeks gestation.
5. Accepting to participate in the study.

Exclusion Criteria:

1. Smoker ≥ 11 cigarettes/day.
2. Caesarean hysterectomy .
3. Surgical management of severe postpartum haemorrhage .
4. History of bowel obstruction , inflammatory bowel disease .
5. Previous abdominal or pelvic radiation
A Study to Explore Treatment Patterns, Treatment Outcomes, Healthcare Resource Utilization in Adult Participants With Acute Myeloid Leukemia (AML) Receiving Venetoclax Through Chart Review

Acute myeloid leukemia (AML), also referred to as acute myelogenous leukemia or acute non-lymphocytic leukemia, is a relatively rare, yet aggressive, type of cancer. This study will evaluate treatment patterns, treatment outcomes, healthcare resource utilization in adult participants with AML receiving venetoclax.

Data from up to 700 participants will be collected. No participants will be enrolled in this study.

Participants' charts will be reviewed. No drug will be administered as a part of this study. The duration of the observation period is up to 10 months.

There is no additional burden for participants in this trial. All visits must be completed prior to data extraction and participants will be followed for up to 10 months.


Eligibility Criteria:
Inclusion Criteria:

* The participant received a diagnosis for acute myeloid leukemia (AML).
* The participant was initiated on the studied line of therapy for previously untreated AML, as noted in the protocol.
* The participant was treated with the studied line of therapy at least 28 days prior to date of data collection.
* Information on the participant's treatments, selected (or important) clinical characteristics, and outcomes is available from the start of the studied line of therapy onwards.

Exclusion Criteria:

* The participant received the studied line of therapy as part of a clinical trial.
* Participant received prior lines of therapy for AML.
* The participant has a history of malignancies within 2 years prior to the studied line of therapy, other than AML, and with the exception of what is noted in the protocol.
Frailty Score and Postoperative Morbidity in Colorectal Cancer Surgery

This prospective observational study aims to evaluate the independent predictive value of the Edmonton Frailty Index (EFI) in estimating postoperative morbidity among older patients undergoing elective colorectal cancer surgery. Frailty, characterized by a decline in physiological reserves and increased vulnerability to stressors, has been recognized as a stronger predictor of adverse postoperative outcomes than chronological age alone. While the relationship between frailty and surgical outcomes has been extensively investigated in general surgical populations, data specifically focusing on patients with colorectal cancer remain limited.

In this study, patients aged 65 years and older scheduled for elective colorectal cancer surgery will undergo preoperative frailty assessment using the validated Edmonton Frailty Index (EFI). Postoperative complications, length of intensive care unit (ICU) stay, total hospital stay, and 30-day adverse outcomes, including mortality, myocardial infarction, pulmonary embolism, sepsis, and the need for reoperation, will be recorded and analyzed.

The primary objective is to determine whether frailty, as measured by the Edmonton Frailty Index, serves as an independent predictor of postoperative morbidity in this specific patient population. Secondary objectives include exploring associations between frailty and intraoperative variables such as blood loss, fluid administration, and vasopressor requirements.

By addressing this gap, the study aims to contribute to the growing body of evidence supporting the routine incorporation of frailty assessment into preoperative risk stratification protocols for older patients with colorectal cancer. The ultimate goal is to enhance perioperative risk assessment, optimize perioperative care, and improve patient outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 65 years and older
* Patients undergoing surgery for colorectal cancer
* Patients scheduled for elective (non-emergency) surgery
* Individuals eligible for preoperative frailty assessment using the Edmonton Frailty Scale (EFS)
* Patients who can be followed for at least 30 days postoperatively
* Patients able to provide informed consent

Exclusion Criteria:

* Patients requiring emergency surgery
* Neurological or psychiatric disorders that prevent the assessment of consciousness level
* Severe comorbidities (Patients with extremely high surgical risk due to severe cardiovascular, respiratory, or other systemic diseases)
* Patients who do not or cannot provide informed consent