cyrilzakka/clinical-trials huggingface dataset:
Q-GAIN (Using Qpop to Predict Treatment for GAstroIntestinal caNcer)

This is a multi-cohort proof of concept study involving patients with metastatic gastrointestinal cancers. In the first cohort of treatment-naïve patients, the investigators intend to create cancer organoids for 100 subjects. Then, the investigators intend to evaluate ex-vivo prediction of treatment outcomes using QPOP (see section 4.0 for detailed sample size calculation).

Patients enrolled on study will undergo a fresh biopsy of tumour lesion to obtain cells that will be used to generate patient-derived tumour organoids. These patients will go on to receive standard of care first-line chemotherapy +/- targeted therapy. Organoids will then be subjected to up to a 14-drug panel screening. The drugs in the respective drug panel have been shown to have activity in the respective cancers and would be used in the standard-of-care setting by treating physicians.

Hypothesis: Ex-vivo sensitivity testing on patient derived tumour organoids using QPOP can identify drug combinations which may have clinical efficacy against metastatic gastrointestinal cancer.

Specific aim 1: To grow patients' gastrointestinal tumour-derived organoids.

Specific aim 2: To perform ex-vivo drug sensitivity testing on patient derived tumour organoids using QPOP for metastatic gastrointestinal cancers.

Specific aim 3: Asses the efficacy of phenotype directed therapy using QPOP to assign treatment after progression of standard of chemo for gastric cancer.

Eligibility Criteria:
Inclusion Criteria:

-

Patients may be included in the study only if they meet the following criteria:

1. Treatment naïve patient with gastrointestinal cancers (i.e. oesophageal, gastro-oesophgeal, gastric, small bowel, colorectal, hepatocellular, pancreatic and biliary tract) fit and planned for first line treatment, OR
2. Chemo-refractory patients with GI cancers deemed by investigator to be fit for clinical trial
3. Age ≥ 21 years
4. ECOG PS 0-1
5. At least 1 tumour lesion amenable to fresh biopsy
6. At least 1 measurable tumour lesion based on RECIST v 1.1 criteria
7. Estimated life expectancy of at least 24 weeks
8. Adequate organ function , including:

   1. Pre-biopsy

      o Bone marrow:
      * Absolute neutrophil (segmented and bands) count (ANC) ≥1.5 x 109/L
      * Platelets ≥ 100 x 109/L
      * Pro-Thrombin within ULN
      * Hemoglobin ≥ 8 x 109/L
   2. Pre-treatment

      * Bone marrow:

        * Absolute neutrophil (segmented and bands) count (ANC) ≥1.5 x 109/L
        * Platelets ≥ 100 x 109/L
        * Hemoglobin ≥ 8 x 109/L
      * Hepatic:

        * Bilirubin ≤ 1.5 x upper limit of normal (ULN),
        * ALT or AST ≤ 2.5x ULN, (or ≤ 5 X with liver metastases)
      * Renal:

        * Creatinine ≤ 1.5x ULN
9. Signed informed consent from patient or legal representative
10. Able to comply with study-related procedures.
11. Recovery from prior toxicity to G1, excluding alopecia.

Exclusion Criteria:

* There are no specific exclusion criteria if patients meet the inclusion criteria
Clinical Efficacy of Combination Therapy Based on High-dose Biapenem in CRKP Infections

Carbapenem resistance is a high mortality rate of Klebsiella pneumoniae infection. It has been proved that high-dose carbapenem can reduce mortality and has a certain clinical effect. In this study, a high dose of biapenem was compared to determine whether it had a similar effect than meropenem.


Eligibility Criteria:
Inclusion Criteria:

* ICU hospitalized for more than 3 days;
* Biapenem used for more than 3 days

Exclusion Criteria:

* Patients who refuse to be included in the group or pregnant women or under the age of 14 or ICU hospitalized for less than 3 days
Erectile Dysfunction/Prostate/RT/Androgen

The optimal duration of hormonal therapy is yet to be determined in the treatment of locally advanced carcinoma of the prostate. The RTOG performed a trial of 4 months of neoadjuvant and concurrent hormones(consisting of Goserelin and Flutamide) compared to radiation alone, and found that there was an improvement in local control and progression-free survival, but no improvement in overall survival. The EORTC performed a similar trial, but used Goserelin alone for a period of 3 years. This trial showed an improvement in local control, disease-free survival, and in contrast to the RTOG trial, an improvement in overall survival.

The rate of erectile dysfunction in men who receive a prolonged period of Gosereline (i.e. 2 yrs) is not known, but suspected according to expert opinion, to be significantly higher than a shorter course of hormonal ablation. Therefore the price of of a survival advantage in locally advanced prostate cancer maybe at a cost of increased rates of erectile dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical stage T1-T4 carcinoma of the prostate
* Must have undergone radical radiation and at least 2 years of Pharmacological androgen ablation.Pharmacological androgen ablation may include: LHRH-agonists with or without Non-steroidal androgen ablation, Steroidal Anti-androgens, Progestational agents, and Cypoterone (Androcur).
* Must be currently 6 months or more after their last injection of LHRH-agonists if it was being given every 3 months or 4 months or more after their last injection, if it was being given monthly. If the patient was on oral androgen ablation agent, they must be off this medication for a period of at least 4 months.
* currently off hormonal therapy
* Able to sign the consent form and fill out questionnaire used in the study.

Exclusion Criteria:

* No patients who have been treated, or are currently being treated with Bicalutamide
* no previous orchidectomy.
Acute Effects of Oxygen Supplementation Among IPF Patients

Idiopathic pulmonary fibrosis (IPF) is a disease characterised with significant morbidity and poor prognosis. Dyspnoea and impaired exercise capacity are very common manifestations of the disease, and result in significant impairment of patients' quality of life. Although hypoxemia is common among subjects with IPF, published data on the effects of supplementary oxygen therapy on specific clinical outcomes among these patients are currently few, while the existing data on the potential benefits of oxygen supplementation to treat exercise-induced hypoxemia, in this patient population, are even more controversial.

Based on the aforementioned, the purpose of this prospective, cross-over clinical trial is to investigate the acute effects of supplemental oxygen administration on the: a) exercise capacity, b) severity of dyspnea, c) cerebral oxygenation, b) muscle oxygenation, and e) hemodynamic profile, as compared to delivery of medical air (sham oxygen), in a group of patients with IPF, without resting hypoxemia, during steady state cardiopulmonary exercise testing (CPET).


Eligibility Criteria:
Inclusion Criteria:

Stable IPF patients with no hospitalization, exacerbation or change in regular IPF medication during the last month, who do not present with resting hypoxemia, but manifest exercise induced hypoxemia

Exclusion Criteria:

1. Major contraindications for CPET conduction
2. Not provision of informed consent -
Application to Predict Neonatal Apnea with Bradycardia

This purpose of this study is to reduce or stop apneas and bradycardias in pre-term infants, before they occur using gentle stimulation.

This will be a randomized cross-over trial that will use additional ECG leads connected to a novel device and laptop to determine the accuracy and efficacy of an algorithm to predict, detect, and interrupt episodes of bradycardia for two 4-hour periods. There will be a 4-hour period without vibro-tactile stimulation and a 4-hour period with vibro-tactile stimulation when episodes are predicted or detected.

Eligibility Criteria:
Inclusion Criteria:

* Documented episodes of apnea with bradycardia over the previous 24 hours.
* Off ventilatory support/NCPAP for \> 48 hours prior to study entry
* Gestational age \< 32 0/7 weeks' gestation at birth
* Parents/legal guardians have provided consent for enrollment

Exclusion Criteria:

* a major malformation or a neuromuscular condition that affects respiration or causes apnea, or terminal illness or decision to withhold or limit support.
A Phase II/III Study of Sargramostim

This is a randomized, placebo-controlled, double-blind, group comparison, multicenter study to evaluate the efficacy and safety of inhalation administration of sargramostim for 5 days, in principle (up to 10 days) as Add-on treatment to the standard treatment in COVID-19 patients.


Eligibility Criteria:
Inclusion Criteria:

Japanese male or female subjects who have been confirmed to meet all the following criteria.

1. Hospitalized patients under treatment who were severe acute respiratory syndrome coronavirus 2 \[SARS-CoV-2\] positive by polymerase chain reaction (PCR) test.
2. Patients with clinically diagnosed pneumonia and a percutaneous oxygen saturation \[SpO2\] of 93% or less on breathing of room air at bed rest.
3. Patients for whom written informed consent has been obtained from those themselves or the legally acceptable representatives.
4. Patients aged 20 years or older and younger than 85 years at the time of obtaining informed consent.

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded. Unless otherwise stated, the following criteria refer to those at the time of screening.

1. Patients who have been participating in other intervention studies, such as studies on unapproved pharmacotherapy, within 90 days prior to screening.
2. Patients who have experienced off-label use of approved drugs (including those for COVID-19 treatment other than steroids as standard treatment) within 7 days prior to screening.
3. Patients who are not expected to survive longer than 24 hours after commencement of study drug administration.
4. Patients who are using invasive ventilator or extracorporeal membrane oxygenation (ECMO).
5. Patients who have a chronic respiratory disease requiring continuous home oxygen therapy or ventilator use.
6. Patients with an underlying condition that is considered very unlikely to withdraw ventilator (e.g., motor neuron disease, Duchenne muscular dystrophy, rapidly progressive interstitial pulmonary fibrosis).
7. Patients who have a disease including bronchial asthma, lower respiratory tract infections, and interstitial lung diseases that may affect the assessment of the clinical study, since before the symptom onset of COVID-19.
8. Patients who have a disease including leukemia and leukocytosis that causes leukocytosis.
9. Patients who have a chronic kidney disease requiring dialysis.
10. Patients who have severe liver failure (Child Pugh grade C).
11. Patients aged 80 years or older with any of heart failure, cerebrovascular disease, obesity (BMI 30 or higher), dyslipidemia, hypertension or diabetes.
Treatment of Primary Peritoneal Carcinosis of Digestive Origin Using Cytoreductive Surgery and Hyperthermic Intraoperative Peritoneal Chemotherapy With Mitomycin C and Irinotecan

This is an open, non-randomized, phase I-II, pilot study, which evaluates the combination of optimum cytoreductive surgery and hyperthermic intraoperative peritoneal chemotherapy (HIPEC) with mitomycin C (MMC) and irinotecan. The latter drug will be administered in escalating doses to patients with gastric, colorectal, appendicular, or primary peritoneal carcinosis (PC).


Eligibility Criteria:
Inclusion Criteria:

* Patients with a peritoneal carcinosis (PC) either of digestive origin or primary: a colorectal or gastric carcinosis, a peritoneal pseudomyxoma or mesothelioma, or a primary carcinosis of the peritoneum regardless the number of prior treatment lines.
* A PC and primary tumor considered to be resectable according to preoperative clinical and paraclinical data: absence of mesenteric retraction and absence of bladder invasion.
* Patients in good general health (ASA ≤ 2).
* Absence of cardiorespiratory failure (PaO2 \> 60 mmHg in a stable condition, dyspnea ≤ NYHA stage 1, left ventricular ejection fraction \> 60%.).
* Prothrombin level \>70 %, total bilirubin \< 2 x the normal level, ASAT and ALAT \< 2.5 x normal levels, and alkaline phosphatases \< 5 x normal levels.
* Creatinine clearance \> 60 ml/min, polynuclear neutrophils \> 1500/mm3, and a white blood cell count \> 4000 /mm3.
* Patients who give written, informed consent.
* Patients affiliated with the French universal healthcare system.

Exclusion Criteria:

* Patients with a PC with ovarian, mammary, biliary, pancreatic, or bronchial origin.
* Evolutive patients after systemic chemotherapy.
* Patients with a PC considered to be irresectable according to preoperative clinical and paraclinical data: mesenteric retraction or bladder invasion.
* Patients in poor general health (ASA \> 2).
* Cardiorespiratory failure (dyspnea \> NYHA stage 1, PaO2 \< 60 mmHg in a stable condition)
* Prothrombin level \< 70 %.
* Any brain abnormality showing on the head scan.
* Signs of heart failure and especially left ventricular ejection fraction \< 60% on the cardiac ultrasound.
* Thrombocytopenia \< 100 000 / mm3
* Visceral metastases other than a single resectable liver metastasis.
* Pregnancy or breast feeding.
* Chronic inflammatory intestinal disease and/or an intestinal obstruction.
* History of severe hypersensitivity to irinotecan hydrochloride trihydrate or one of the excipients of Campto.
* Bilirubinemia \> 3 times the normal upper limit
* Yellow fever vaccine.
* Prophylactic treatment with phenytoin.
* Severe medullary insufficiency.
Evaluation of a Peer Counseling Breastfeeding Support Program for Mother-preterm Infant Dyads

Breastfeeding has a fundamental impact on the short-, medium- and long-term health of children and has an important impact on women's health. Breastfeeding protects against gastrointestinal and respiratory illnesses and is associated with better cognitive development in childhood, particularly in preterm infants. Despite these potential benefits, preterm infants experience lower rates of breastfeeding initiation and continuation compared to term infants.

The use of breastfeeding peer support initiatives, in which advice is given by experienced and trained peer counselors, is an effective way to promote and support breastfeeding, regardless of a woman's socioeconomic status. Several small studies have shown that breastfeeding peer support initiatives were effective for preterm infants and that this efficacy was increased by the co-intervention of lactation consultants.

The purpose of this study is to develop and to evaluate the effectiveness of a breastfeeding support program among mother-preterm infant dyads in Europe, by evaluating the impact of the intervention on 1) breastfeeding rates, 2) morbidity and mortality during the hospitalization, 3) children's cognitive development and behavior 4) mothers' mental health, 4) costs benefits.

The breastfeeding support program will include peer counselors under the supervision of lactation consultants. Breastfeeding counselors will be voluntary mothers who have had a positive breastfeeding experience with at least one preterm infant. After a training course, they will meet the future or new mothers by face-to-face and share their experiences at least once a week during hospitalization and provide phone support up to 1 month after discharge from hospital.

The study design will be a stepped wedge cluster trial conducted in 8 NICU in Europe (France, Switzerland and Belgium). Infants and mothers will be followed up from the time of hospitalization in the maternity and NICU up to 6 months after the discharge. The cost analysis will be performed in a subgroup of mother-preterm infant dyads that will be followed up at 24-months after their discharge


Eligibility Criteria:
Inclusion Criteria:

* any infant born \<35 weeks' gestation,
* hospitalised in NICU before 24 hours old
* and younger than 168 hours (7 days) old.

Exclusion Criteria:

* infant with foetal malformation that is life-threatening
* infant with medical contraindication for breastfeeding
* parent(s)' non-consent to be involved in the study
* mother with prolonged medical contraindication for breastfeeding
* mother with psychiatric disorders making breastfeeding support impossible
* if no communication is possible with the mother
* if the level of communication with the mother does not allow breastfeeding support, with or without a third party
Safety and Efficacy of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroid in Moderate-to-Severe Atopic Dermatitis.

This is a randomized, double-blind, placebo-controlled, parallel-group study which is 16 weeks in duration. The study is designed to evaluate the safety and efficacy of lebrikizumab when used in combination with topical corticosteroid (TCS) treatment compared with placebo in combination with TCS treatment for moderate-to-severe atopic dermatitis.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female adult and adolescents (≥12 years to \<18 years, and weighing ≥40 kg).
2. Chronic AD (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before the screening visit.
3. Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit.
4. Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline visit
5. ≥10% body surface area (BSA) of AD involvement at the baseline visit.
6. History of inadequate response to treatment with topical medications.

Exclusion Criteria:

1. Participation in a prior lebrikizumab clinical study.
2. Treatment with the following prior to the baseline visit:

   1. An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer.
   2. Dupilumab within 8 weeks.
   3. B-cell-depleting biologics, including to rituximab, within 6 months.
   4. Other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer.
3. Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study.
4. Uncontrolled chronic disease that might require bursts of oral corticosteroids.
5. Evidence of active acute or chronic hepatitis
6. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
7. History of malignancy, including mycosis fungoides, within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.
8. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
Patient Decision Aid for Antidepressant Use in Pregnancy

The purpose of this pilot study is to examine the feasibility of conducting a multi-site randomized controlled trial whose aim will be to evaluate the effectiveness of a Patient Decision Aid (PDA) for antidepressant use in pregnancy.

Depression in pregnancy is common, affecting up to 10% of women and represents serious risk to mother and infant. Unfortunately, antidepressant medication, a first-line treatment for depression in pregnancy, also comes with risks, making this a complex decision. Clinical care appears to be insufficient for ensuring that women make decisions that are consistent with their own values and with which they feel satisfied. Patient decision support tools can address such barriers. We have created a patient decision aid (PDA) that has the potential to improve the decision-making process for women regarding antidepressant use in pregnancy in conjunction with clinical care. The overall objective of this project is to inform the development of a larger, international RCT to assess the efficacy of our PDA for antidepressant use in pregnancy. To achieve this objective, we will assess the feasibility of our clinical trial protocol to evaluate the PDA and determine the preliminary effect size for a larger multi-site efficacy study. The primary outcome for this pilot study is the feasibility of conducting a large randomized controlled trial to evaluate the efficacy of the PDA. This includes feasibility (how well the trial protocol can be implemented), acceptability (usability and tolerability of the intervention) and adherence (the degree to which the trial protocol is followed). We hypothesize that our protocol will be feasible, that the PDA will have a high degree of acceptability, and that adherence to the protocol will be high.

Eligibility Criteria:
Inclusion criteria:

1. Are females aged \>18 years old, and
2. Are either planning a pregnancy OR are \<30 weeks gestation at enrollment, and
3. Have been offered to start or continue SSRI or SNRI anti-depressant medication as a treatment option for depression by their clinical provider at one of the study sites, and
4. Have moderate-to-high decisional conflict (score of \>25 on the Decisional Conflict Scale)

Exclusion criteria:

1. Have had alcohol or substance abuse or dependence in the previous 12 months, or
2. Have active suicidal ideation or psychosis, or
3. Are incapable of consenting to participation, or
4. Have any major obstetrical complications or fetal cardiac anomaly in the current or in a past pregnancy (as this changes the risk/benefit ratio discussion in regards to antidepressant use), or
5. Are unable to read or unable to speak or understand English and do not have someone that can read the PDA to them, or
6. Have a visual impairment that would prevent them from being able to view the website.