cyrilzakka/clinical-trials huggingface dataset:
A Clinical Trial of a New Combination Treatment, Domvanalimab and Zimberelimab, Plus Chemotherapy, for People With an Upper Gastrointestinal Tract Cancer That Cannot be Removed With Surgery That Has Spread to Other Parts of the Body

This randomized Phase 3 open-label study will compare the efficacy of the T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif (ITIM) domain (TIGIT) monoclonal antibody domvanalimab, the anti programmed cell death protein 1 (PD-1) monoclonal antibody zimberelimab, and multiagent chemotherapy versus the anti PD-1 monoclonal antibody nivolumab and multiagent chemotherapy in the first-line treatment of participants with locally advanced unresectable or metastatic gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma.


Eligibility Criteria:
Key Inclusion Criteria:

* Capable of giving signed informed consent which is in compliance with the requirements and restrictions listed in the informed consent form (ICF) and in protocol.
* Histologically confirmed diagnosis of locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* At least one measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Key Exclusion Criteria:

* Underlying medical or psychiatric conditions that, in the investigator's or sponsor's opinion, will make the administration of study-specified therapy hazardous, including but not limited to:
* Interstitial lung disease, including history of interstitial lung disease or non-infectious pneumonitis. Active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of randomization.
* Clinically significant cardiovascular disease, such as New York Heart Association Class II or greater cardiac disease or cerebrovascular accident within 3 months prior to randomization, unstable angina, or new onset angina within 3 months prior to randomization, myocardial infarction within 6 months prior to randomization, or unstable arrhythmia within 3 months prior to randomization.
* History of prior solid-organ transplantation, including allogenic bone marrow transplantation.
* Dementia, psychiatric, or substance abuse disorders that would interfere with satisfying the requirements of the trial.
* Known human epidermal growth factor receptor 2 (HER-2) positive tumor.
* Known untreated, symptomatic, or actively progressing central nervous system (CNS) (brain) metastases. Participants with leptomeningeal metastases are excluded from enrollment.
* Received prior systemic treatment for locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma.
* Disease progression within 6 months of completion of neoadjuvant or adjuvant therapy.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Validation of the Italian Version of the PRO-CTCAE

The aim of this study is to complete the validation process by testing the remaining two psychometric properties (validity and responsiveness) of the Italian version of the PRO-CTCAE in a large group of patients. In particular, for the first time this study will validate the tool for individual types of cancer and will provide information on psychometric properties based on the type of treatment used in clinical practice.

This is a prospective observational study, conducted in Italian cancer centers located Nationwide.

The investigators plan to consider for validation 21tumor sites, which correspond to the conditions for which a specific EORTC module has been produced, plus all remaining cancer types classified as "other setting".

The study will take place during two planned visits, one the first the day of enrollment, the second after 3-6 weeks. Enrolled patients will be asked to complete a subset of the PRO-CTCAE items based on cancer type, and the following instruments used as anchors to measure psychometric properties:

* EORTC Quality of Life disease-specific module, if a linguistically validated Italian version exists, or the General QLQ-C30, if the Italian version is not available.
* the Hospital Anxiety and Depression Scale (HADS)
* The Patients' Global Impression of Change (PGIC) Scale

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of any type of cancer

  •≥18 years of age.
* Female or male
* With at least two planned clinic visits (a return visit within 3-6 weeks) to avoid the need of extra visits
* Actively receiving treatment for cancer (going to receive the second or further cycle)
* Any ECOG performance status (PS)
* Able to complete questionnaire by themselves or with assistance, by using a tablet
* Able to speak and understand Italian
* Providing informed written consent

Exclusion Criteria:

* Having any kind of psychiatric disorder or major cognitive dysfunction hampering the provision of informed consent.
* Having received more than 5lines of therapies
* Currently participating in other trials which imply the completion of Patient Reported Outcomes (PROs) in the same period
* Other important acute medical conditions.
Exploring Clinical Trial Experiences of Patients With Migraine

Clinical study participation has historically been heavily biased toward specific demographics.

This study will invite several participants to gather a wide range of information on clinical trial experiences for migraine patients. The aim of the study is to identify the factors that limit the ability of a person to enroll in, as well as complete a clinical trial for treatment of migraine.

People with migraine who are invited to take part in medical research will benefit from the analysis of the data.


Eligibility Criteria:
Inclusion Criteria:

* Patient is a minimum of 18 years of age
* Patient has been diagnosed with a type of migraine
* Patient plans to participate in an interventional clinical trial for the condition of migraine
* Patient has access to a home internet connection in order to provide regular updates through the course of the study

Exclusion Criteria:

* Patient has an ECOG score of 4 or higher
* Patient is not able to provide consistent digital updates as per study requirements
* Patient does not complete or agree to terms outlined in the Informed Consent Form
New Treatment Perspectives in Eating Disorders: the Efficacy of Non-invasive Brain-directed Treatment

The present study grounds on the possible role of hemispheric lateralization in Eating disorders (ED): specifically, hyperactivity of the right frontal regions in Anorexia Nervosa (AN), and hypoactivity of the right frontal regions in Binge Eating Disorder (BED) and food craving behaviors.

Therefore, the investigators hypothesized that active excitatory tDCS over left prefrontal cortex (PFC) (Anode left/cathode right) may aid in altering/resetting inter-hemispheric balance in AN patients, re-establish control over eating behaviors. On the contrary, active excitatory tDCS over right PFC (Anode right/cathode left) may aid in altering/resetting inter-hemispheric balance in BED patients and people with frequent food cravings, decreasing cravings/appetite binge eating behaviors.

The study design is randomized stratified, double blind, add-on, placebo-controlled.

A group of children and adolescents with AN will be selected and randomly assigned to two different conditions: treatment "as usual" plus experimental treatment (active tDCS); treatment "as usual" plus placebo treatment (sham tDCS).

Similarly, a group of children and adolescents with Over-weight/Obesity (OW/OB) and BED will be selected and assigned with randomized stratified sampling to the following conditions: treatment "as usual" plus experimental treatment (active tDCS); treatment "as usual" plus placebo treatment (sham tDCS).

In this project, the investigators will work to understand whether a brain-based treatment, with the use of tDCS, can improve the outcome of patients with eating disorders.

The investigators will test whether tDCS treatment produces improvements in under-eating and over-eating diseases, such us AN and OW/OB with BED and food craving.

Our overarching goal is to provide a scientific foundation for devising new rehabilitation strategies in ED.

Eligibility Criteria:
Inclusion Criteria:

* Under-weight (BMI less than 5th percentile)1 with Clinical diagnosis of AN as described in the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
* Over-weight/Obesity (OW/OB) (BMI above the 85th percentile)1 with diagnosis of BED, or with food craving behaviors
* Ability to give informed consent under parents' surveillance and guidance

Exclusion Criteria:

* Having a comorbidity with an important medical condition;
* Having neurological diseases
* Having Epilepsy o family history of epilepsy
* Pregnant or planning to become pregnant;
* Suicide risk;
* Receiving counseling or psychological therapies during the study;
* Receiving a treatment for an eating disorder in the previous three months before the baseline screening visit.
A Trial of Single Dose Corifollitropin Alfa's Ability to Induce Multiple Follicular Growth During the First Week of Controlled Ovarian Stimulation for IVF or ICSI (38833)(P05788)

To evaluate the induction of multiple follicular growth after single dose administration of 100 μg or 150 μg Org 36286 in a long protocol of GnRH agonist.

In this trial, all subjects were (pre)treated daily with subcutaneous triptorelin, a GnRH agonist which is known to provide profound suppression of endogenous LH and FSH. It was evaluated whether these down-regulated subjects show an appropriate ovarian response to 100 μg or 150 μg Org 36286 during the first week of stimulation. To evaluate this, follicular growth was measured by USS, and serum inhibin-B and E2 levels were assessed.

Eligibility Criteria:
Inclusion Criteria:

* Females of couples with an indication for controlled ovarian stimulation (COS) and IVF or ICSI that have had at least one previous COS cycle with proven normal ovarian response;
* \>=18 and \<= 39 years of age at the time of signing informed consent;
* a. First group: Body weight \>= 50 kg and BMI \>= 18 and \<= 29 kg/m\^2; b. Second group: Body weight \<= 60 kg and BMI \<= 29 kg/m\^2;
* Normal menstrual cycle length: 24-35 days;
* Ejaculatory sperm (use of donated and/or cryopreserved sperm is allowed);
* Normal routine diagnostic hysteroscopy and endometrial biopsy;
* Willing and able to sign informed consent.

Exclusion Criteria:

* History of or any current (treated) endocrine abnormality;
* History of ovarian hyper-response1 or history of ovarian hyperstimulation

syndrome (OHSS);

* History of or current polycystic ovary syndrome (PCOS);
* A basal antral follicle count \> 20 (size \< 11 mm, both ovaries combined) on USS during the early follicular phase (menstrual cycle day 2-5);
* Less than 2 ovaries or any other ovarian abnormality;
* Presence of unilateral or bilateral hydrosalpinx (visible on USS);
* Presence of unilateral or bilateral endometriomas (\>10 mm; visible on USS);
* More than three unsuccessful COS cycles since the last established ongoing

pregnancy (if applicable);

* History of non- or low ovarian response to FSH/hMG treatment;
* FSH or LH \> 12 IU/L as measured by the local laboratory (sample taken during the early follicular phase: menstrual cycle day 2-5);
* Any clinically relevant abnormal laboratory value based on a sample taken during the screening phase;
* Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts) or GnRH analogues (e.g. hypersensitivity, pregnancy/lactation);
* Recent history of or current epilepsy, diabetes or cardiovascular, gastro-intestinal, hepatic, renal or pulmonary disease;
* History or presence of alcohol or drug abuse within 12 months prior to signing informed consent;
* Previous use of Org 36286;
* Use of hormonal preparations within 1 month prior to screening;
* Administration of investigational drugs within three months prior to signing

informed consent.
Safety and Pharmacokinetics of Extrato De Cannabis Sativa GreenCare

The goal of this Phase I clinical trial is to assess the pharmacokinetic availability and safety and tolerability profile of Extrato de Cannabis sativa GreenCare 79.14 mg/mL. The main question it aims to answer is:

• Is the Extrato de Cannabis sativa GreenCare 79,14 mg/mL safe?


Eligibility Criteria:
Inclusion Criteria:

* Men and women from 18 to 65 years, inclusive;
* Body weight ≥ 50 kg and BMI between 18.5 and 30 kg/m2, inclusive;
* Be healthy according to medical history, i.e., have laboratory test results within normal ranges and/or any deviations from normal classified as clinically insignificant;
* Be exclusively participating in this clinical study during the research period;
* Understand and comply with the protocol requirements and consent to participate in the study by signing the Informed Consent Form (ICF) approved by an Ethics Committee (EC).

Exclusion Criteria:

Having participated in any experimental study or ingested any experimental drug within 1 (one) year prior to the start of this study;

* Inability to use oral medication and/or cooperate with investigators due to cognitive impairment or mental state;
* Reported allergy to any component of Cannabis sativa extract 79.14 mg/mL;
* Personal or first-degree family history of schizophrenia, bipolar affective disorder, psychotic symptoms, suicidal ideation, planning and/or attempt, and/or severe uncontrolled psychiatric comorbidities, at the discretion of the principal investigator;
* Donated blood within four (4) months prior to signing the Informed Consent Form (ICF);
* Being pregnant, breastfeeding, intending to become pregnant during the study period, or having a positive result for urinary β-HCG testing;
* Reported use of Cannabis and/or its derivatives for any purpose in the past 6 months;
* Personal history of Cannabis use disorder and/or other illicit drug use disorder;
* Personal history of alcohol, tobacco, opioid, benzodiazepine, barbiturate, and/or other substance use disorders, such as St. John's Wort;
* Smokers or ex-smokers who quit less than 6 months ago;
* Consumed alcoholic beverages within 24 hours before the study confinement period;
* Any condition that prevents participation at the discretion of the investigator;
* Dietary habits that prevent ingestion of the diet provided during the study;
* Any clinical or laboratory finding or therapy that, at the investigator's discretion, may place the participant at risk or interfere with study objectives or outcomes;
* Non-compliance with the complete ingestion of the diet provided - determination at the discretion of the responsible physician.
CALM: Managing Distress in Malignant Brain Cancer

The purpose of this study is to test an empirically supported psychotherapeutic intervention, Managing Cancer and Living Meaningfully (CALM), compared to treatment as usual (TAU) in those with malignant brain cancer diagnoses.


Eligibility Criteria:
Inclusion Criteria:

* Self-reported diagnosis of brain metastasis (bMET) or a malignant primary brain tumor (PBT; specifically grade III or IV and CNS diffuse large B cell lymphomas)\*
* At least 2-weeks post-surgical resection or biopsy of the brain (if applicable)
* Score \> 20 on the TICS
* Reported elevated depression (PHQ-9 score ≥ 10) OR death anxiety symptoms (DADDS score ≥ 15)
* Ability to read, speak, and understand English
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Major communication difficulties which would prohibit the psychotherapeutic interaction
* Inability to meet with the interventionist via an electronic device for telehealth intervention sessions
* Inability to understand and provide informed consent
* Prisoners
* Medical, psychological, or social condition that, in the opinion of the principal investigator, may increase the participant's risk of adverse events and/or prohibit the individual's participation in the intervention.
Respiratory and Hemodynamic Changes Induced in Mechanically Ventilated Patients for COVID-19

In the present context, it seems necessary to try to describe as precisely as possible the physiological alterations due to COVID-19. From these observations, therapeutic proposals adapted to this new disease may then be developed, particularly in the symptomatic management of the critically ill patient. It therefore seems essential to rigorously study these modifications, as they have been studied in the past for ARDS.

The aim of this non-interventional study is to describe precisely the respiratory and hemodynamic changes induced by COVID-19 in mechanically ventilated patients

.


Eligibility Criteria:
Inclusion Criteria:

* hospitalized in intensive care for a SARS-CoV2 infection
* requiring invasive ventilation,
* intubated for less than 72 hours with PaO2/FiO2 ratio \< 200 mmHg

Exclusion Criteria:

* Patient mechanically ventilated for 72 hours or more
* Patient with documented respiratory co-infection
* Patient with a contraindication to pulmonary artery catheter insertion: High risk of bleeding, pre-existing high degree of atrioventricular heart block , Pace Maker
* Patient with spontaneous ventilation
* Patient with severe ARDS with static compliance of the respiratory system \< 20 mL/cmH2O
* Patient with severe ARDS with indication of prone positioning at inclusion.
* Patient with a cardiac condition that renders the measurement of pulmonary artery occlusion pressure uninterpretable as a surrogate for left ventricle end diastolic pressure (severe mitral insufficiency, severe mitral stricture, severe aortic insufficiency).
* Patient with intracardiac shunt
* Patient with ECMO
* Minors and pregnant women.
* Person not affiliated to or not benefiting from a social security scheme.
To Evaluate the Efficacy and Tolerability of Sodium Bicarbonate Toothpaste

The primary objectives of this study will be to compare the Gingival Bleeding and Gingival Inflammation following twice daily use of a sodium bicarbonate experimental dentifrice compared to a 0% sodium bicarbonate toothpaste after 24 weeks of use. The study will be conducted at Silverstone Research Group. Participants will be recruited from their database and by use of an external recruitment agency.


Eligibility Criteria:
Inclusion Criteria:

* Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral/dental examination.
* A minimum of 20 permanent gradable teeth
* Moderate gingivitis present at the screening visit in the opinion of the investigator
* A total of 20 bleeding sites or greater at baseline visit
* Positive response to bleeding on brushing present at the screening visit

Exclusion Criteria:

* Pregnant or breast feeding women
* Tobacco chewers
* Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any other medical condition (e.g. Diabetes Mellitus) that would make the participant unlikely to fully complete the study or any that increases the risk to the participants or undermines the data validity.
* Recent history (within the last year) of alcohol or other substance abuse
* Participants requiring prophylactic antibiotic treatment prior to dental therapy
* Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
* Have current active caries or any medical conditions which may directly influence gingival bleeding
* Use of concomitant or any systemic medication that, in the opinion of the investigator, might interfere with the outcome of the study or have an effect on gingival conditions within 14 days of gingival examinations
* Excessive calculus present that interferes with the probing examination for Gingival Bleeding Index
* Participation in another clinical study or receipt of an investigational drug or oral care product within 30 days of the screening visit
* An employee of the sponsor or the study site or members or their immediate family.
Eliminate Risk of Cardiac Surgical Site Events

The purpose of the study is to see if using 2% Chlorhexidine cloths will reduce surgical site infections in patients having elective cardiac surgery.

A randomized, prospective study utilizing 2% Chlorhexidine cloths to evaluate the product's effectiveness in reducing surgical site infections in elective cardiothoracic surgery patients. Sage 2% chlorhexidine cloths are approved by the Food and Drug Administration (FDA) for preparation of skin prior to surgery.

The study hypothesis is that the preoperative surgical preparation with 2% chlorhexidine cloths, which leaves chlorhexidine on the skin, will reduce surgical site infections by 50% as compared to current standard procedure.

Eligibility Criteria:
Inclusion Criteria:

* Elective cardiothoracic surgery patients \> 18 years old.
* Informed consent obtained

Exclusion Criteria:

* Any current known allergies to chlorhexidine gluconate
* Currently taking any oral or topical antibiotics
* Any active skin rashes or breaks in the skin on areas to be treated with chlorhexidine gluconate
* A current active skin disease or inflammatory skin condition, known pre-existing skin infection, including contact dermatitis that is currently being treated with an antibiotic
* Any medical condition or use of any medications that in the opinion of the Principal Investigator preclude participation.
* Unwillingness or failure to fulfill requirements of the study
Feeding Progression in Preterm Infants

Preterm infants face many feeding challenges during hospitalization which can prolong hospitalization, raise parental anxiety and can lead to medical instability. The Feeding Progression study will randomize preterm infants to one of two currently accepted oral feeding schedules; oral feed attempts every 3 hours or every 6 hours. The study will collect data on oral feeding success, milk transfer, sucking strength, growth and medical complications.

Preterm infants are at high risk for feeding issues. Feeding difficulties lead to prolonged hospitalization, increase medical complications and raise parental anxiety. The transition from tube feeding to oral feeding is an especially important step in a preterm infant's early life. Currently, there is limited evidence to guide this transition. There are two commonly used schedules for transitioning preterm infants to oral feeding: an every 6 hour schedule and an every 3 hour schedule. However, there is currently no evidence to guide providers in their choice of oral feeding schedule.

The primary objective of this study is to explore whether an every 6 (q6) hour oral feeding schedule will improve time to full oral feedings as compared to an every 3 (q3) hour oral feeding schedule. The secondary objectives are to test whether every 6 hour feeding allows for improved medical stability and oral-motor coordination as compared to the other commonly used q3 hour schedule. Each infant will be randomly assigned to a q6 hour or q3 hour oral feeding schedule. Data on oral feeding progression, respiratory status and oral motor proficiency will be collected and compared. The study will collect data on how long it takes each infant to get to full oral feeds, respiratory status throughout their time of oral feeding, whether there were any episodes of medical complications, measures of oral motor feeding skills, and the time to discharge from the hospital. This study is a crucial first step towards determining which feeding schedule is optimal for preterm infants to ensure timely attainment of full oral feeds and hospital discharge without compromising medical stability.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age between 23 0/7-33 0/7 weeks
* Eligible for oral (PO) feeding as determined by the attending Neonatologist

Exclusion Criteria:

* Infants with major congenital malformations
* Infants with chromosomal defects
* Diagnosis of Neonatal Abstinence Syndrome or opiate withdrawal
* Grade 3 or 4 Intraventricular Hemorrhage