cyrilzakka/clinical-trials huggingface dataset:
A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer

The main objective of the Phase 2 part of the study is to evaluate the efficacy of bemarituzumab (FPA144), a targeted antibody, in combination with modified FOLFOX6 compared to placebo in combination with modified FOLFOX6 in participants with advanced gastrointestinal cancer.

Study FPA144-004 is a phase 1/2, multicenter, global, double-blind, randomized, controlled study designed to evaluate the safety, tolerability, efficacy, and pharmacokinetics (PK) of bemarituzumab in combination with mFOLFOX6, compared with placebo in combination with mFOLFOX6, in adults with unresectable, locally advanced, or metastatic gastric cancer including cancer of the gastroesophageal junction (GEJ).

This study includes a Phase 1 safety run-in portion and a Phase 2 portion. The Phase 1 safety run-in is an open-label dose-escalation of bemarituzumab + mFOLFOX6 in patients with GI tumors (not FGFR2 selected) that is reported separately (NCT03343301).

The Phase 2 portion of the study (to follow the Phase 1 safety run-in) is described in this record.

Eligibility Criteria:
Key Inclusion Criteria:

* Histologically documented gastric or gastroesophageal junctional adenocarcinoma (not amenable to curative therapy)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* Adequate hematological, liver and kidney function. Measurable or non-measurable, but evaluable disease using RECIST v1.1
* Fibroblast growth factor receptor 2b (FGFR2b) overexpression as determined by a centrally performed immunohistochemistry tissue test and/or FGFR2 gene amplification as determined by a centrally performed circulating tumor deoxyribonucleic acid (ctDNA) blood based assay
* Candidate for mFOLFOX6 chemotherapy

Key Exclusion Criteria:

* Untreated or symptomatic central nervous system (CNS) metastases
* Clinically significant cardiac disease,
* Peripheral sensory neuropathy \>/= Common Terminology Criteria for Adverse Events (CTCAE) Grade 2
* Active infection requiring systemic treatment
* Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or known active or chronic hepatitis B or C infection
* Prior treatment with any selective inhibitor of the fibroblast growth factor (FGF)-FGFR pathway
* Known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer
* Known positivity for human epidermal growth factor receptor 2 (HER2)
* Women who are pregnant or breastfeeding

Note: Other protocol defined Inclusion/Exclusion criteria may apply
Management of Acutely Symptomatic Hernia

Acutely symptomatic abdominal wall hernia can cause many symptoms and complications. They can be associated with levels of morbidity beyond that seen in emergency laparotomy. There is limited data to guide practice in this field. This observational cohort study will explore variation in practice around assessment, repair and outcomes of hernias treated in the emergency setting.

There are many different types of hernia, with the most common being in the groin or at the umbilicus. Hernias affect a significant proportion of the population and can vary from producing no symptoms at all, to causing a blockage to the bowel that requires urgent surgery. Hernias affect people of all ages and degrees of health, but become increasingly common with age. As our population ages and therefore becomes generally more unwell, the risks of surgery increase. Recent evidence suggests that emergency hernia repair is associated with worse outcomes than planned procedures. At present there are limited guidelines for the management of acutely symptomatic hernias and therefore practice varies between hospitals.

This cohort study will capture information on patients treated in the UK for acutely symptomatic hernia, and will provide information on variation in assessment, and technical aspects of repair. It will also capture health utility data out to 90 days post discharge from hospital.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and over
* Patients admitted directly to the emergency surgery service (via A+E or GP)
* Patients referred to the emergency surgical team by another inpatient specialty
* Patients with a diagnosis of an acutely symptomatic hernia made by a specialist surgical trainee (ST3+) or Consultant Surgeon
* Willing to take part in the study

Exclusion Criteria:

* Patients under 18 years of age
* Pregnant women
* Patients with a symptomatic parastomal, hiatal or diaphragmatic hernia
* Patients with a traumatic hernia
* Unable to consent
Vitamin D for Chronic Sinusitis

The purpose of this study is to examine if vitamin D improves the symptoms of chronic sinusitis.


Eligibility Criteria:
Inclusion Criteria:

* African American (4 grandparents with AA ancestry)
* Age\>18 years
* Diagnosis of chronic sinusitis

Exclusion Criteria:

* Women of childbearing potential not utilizing contraception
* Subjects with contraindications to vitamin D therapy
* History of nephrolithiasis, hypercalcemia, sarcoidosis, recent (3 month) hospitalization
* Use of immunosuppressants/medications that interfere with vitamin D metabolism (e.g., phenytoin and carbamazepine)
* Malignancy
* Kidney, gastrointestinal, or liver disorders
* Immunodeficiency
* Morbid obesity (BMI\>35 kg/m2)
* Changes to medications for 6 months prior to study entry
Axillary Block in Association With Analgesic Truncal Blocks at the Elbow for Wrist Surgery.

Fractures of the forearm bones that occur around the wrist are common in the elderly. Standard anesthesia for its surgical treatment is regional anesthesia (RA): supraclavicular block, infraclavicular block or axillary block (BAX). However, these techniques have some limitations, such as the postoperative pain management and the non-specificity of the analgesia. Indeed analgesia is not specific to the wrist and extends to the elbow and forearm, preventing rapid recovery of elbow flexion and extension when a long-acting local anesthetic (LA) is used. Recently RA techniques associating proximal anesthetic blocks with distal analgesic blocks have been proposed to serve a dual objective: good anesthesia for surgery and specific analgesia.

The hypothesis of this study is that, for the wrist surgery, axillary block using a short-acting LA combined with analgesic blocks at the elbow using a long-acting LA could provide a RA installation time reduction, an optimal surgical comfort, a longer post-operative analgesia duration and a faster recovery from motor block.

This multicenter, prospective, randomized, open-Label study compares two techniques :

* BAX (usual technique) : Axillary brachial plexus block (Axillary block) with a long-acting LA (Ropivacaine)
* BAX-Asso (experimental technique) : Axillary brachial plexus block (Axillary block) with a short-acting local anesthetic (Lidocaine) + Analgesic block at the elbow with a long-acting local anesthetic (Ropivacaine) Every block will be performed under Ultrasound. BAX will be performed using a multi-injection technique at contact with median (nM), radial (nR), ulnar (nU), musculocutaneous (nMC) and medial antebrachial cutaneous (nCMAB) nerves. 15-30 mL of LA will be injected.

Analgesic truncal blocks of the median and radial nerves will be performed at the elbow. 3-7 mL of LA will be injected.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing wrist fracture surgery under regional anesthesia
* Consent for participation
* Affiliation to the French social security system

Exclusion Criteria:

* Chronic use of opiod analgesics
* Chronic pain syndrome or fibromyalgia
* Contraindication for locoregional anesthesia
* Contraindication for opioid
* ASA IV
* Pregnant or breastfeeding women
* Patients under protection of the adults (guardianship, curators or safeguard of justice)
* Communication difficulties or neuropsychiatric disorder
Computer Assisted Vasopressor Titration in Critically Ill Patients

The purpose of this pilot study is to evaluate the performance of a novel closed-loop (automated) vasopressor administration system that delivers norepinephrine using feedback from standard operating room hemodynamic monitor (EV1000 Monitor-Flotrac Edwards Lifesciences, IRVINE, USA) in 10 to 12 critically ill patients in the intensive care unit.

The investigators have developed an automated closed-loop system for vasopressor administration . They will test it in critically ill patients. The investigators want to demonstrate that the closed-loop system can maintain mean arterial pressure ( MAP) within a very narrow range (within +/- 5 mmHg of the predefined MAP target) for more than 85 % of the treatment time.

The Investigators have shown this to be the case in simulation studies and in-vivo animal studies and in surgical patients but not yet in the Intensive care unit (ICU). Investigators will recruit 10 to 12 ICU patients equipped with a mini-invasive cardiac output monitoring and under continuous norepinephrine infusion.

These patients will typically include: septic patients, neuro ICU patients, ARDS patients, trauma patients or postoperative patients.

The target MAP will be determined by the ICU physician in charge of the patient.

Fluids will be given standard of care. The closed loop (automated) system will use an infusion pump (Q-Core and chemyx pump) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments of vasopressor (norepinephrine)

The goal is to register a period of two hours of closed-loop control of MAP.

Eligibility Criteria:
Inclusion Criteria:

- ICU patients under norepinephrine administration and equipped with a advanced hemodynamic monitoring device

Exclusion Criteria:

* Subjects under 18 years of age
* Subjects not requiring cardiac output monitoring or an arterial line
* Subject with Atrial Fibrillation
* Subjects who are pregnant
Plasma Volume Replacement (PVR) Therapy With Colloid and Crystalloid Solutions

The purpose of this study is to investigate the efficacy of target controlled fluid therapy with a hyper-oncotic balanced HES solution compared to an iso-oncotic HES solution in patients undergoing elective surgery of the pancreatic head. A third group receiving a balanced electrolyte solution (without colloidal volume replacement) will serve as a control for descriptive analysis.


Eligibility Criteria:
Inclusion:

* patients scheduled to undergo elective surgery of the pancreatic head
* patients who are willing to give of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Institutional Ethics Committee (IEC) prior to all evaluations.

Exclusion:

* patients of American Society of Anesthesiologists (ASA) class \> III
* heart failure defined as New York Heart Association (NYHA) class\>2
* aneurysm of the ascending and thoracic aorta
* patients with Zenker's diverticle
* local oesophageal disease (oesophageal stricture, oesophageal varices, previous oesophageal surgery in past 6 months before study inclusion, pharyngeal pouch)
* patients receiving haemodialysis
* patients with known bleeding diatheses
* any bleeding disorder known from patient's history
* patients with a haematocrit \<= 25% despite pre-operative transfusion
* renal insufficiency (serum creatinine \> 130 µmol/l or \>1.5 mg/dl) or oliguria or anuria
* impaired hepatic function defined as Mayo End-Stage Liver Disease (MELD) \> 10 or liver cirrhosis Child-Pugh B or C
* additional contra-indications for investigational products
Novel Therapy for Poor Responders Management

Unfortunately for some infertile women, gonadotrophin administration results in a desultory ovarian response. While this is commonly due to diminished ovarian reserve, as indicated by advanced age and/or elevated basal day 3 FSH concentrations, a subset of these patients are \<41 years old and have normal FSH concentrations.

To overcome this problem several strategies have been reported, with limited success.

With approval of the Board, 100 women with a history of previous poor response to vigorous gonadotrophin stimulation. All with AFC ≤3, AMH;≤0.5 and they give only ≤3 oocytes in their previous cycles will be included in this study using this new protocol: clomiphene citrate 150 for 7 days starting on DAY2, associated with HMG 300 IU \& Groth hormone 8 units in alternating days (i.e.; HMG on D2,4,6,8 while GH on D3,5,7,9) then folliculomonitoring will be started on D9, then Antagonist may be added till triggering then will see the response compared to their own ovarian response before

Unfortunately for some infertile women, gonadotrophin administration results in a desultory ovarian response. While this is commonly due to diminished ovarian reserve, as indicated by advanced age and/or elevated basal day 3 FSH concentrations, a subset of these patients are \<41 years old and have normal FSH concentrations.

To overcome this problem several strategies have been reported, with limited success.

With approval of our Board, 100 women with a history of previous poor response to vigorous gonadotrophin stimulation. All with AFC ≤3, AMH;≤0.5 and they give only ≤3 oocytes in their previous cycles will be included in this study using this new protocol: clomiphene citrate 150 for 7 days starting on DAY2, associated with HMG 300 IU \& Groth hormone 8 units in alternating days (i.e.; HMG on D2,4,6,8 while GH on D3,5,7,9) then folliculomonitoring will be started on D9, then Antagonist may be added till triggering then will see the response compared to their own ovarian response before in their previous trials

Eligibility Criteria:
Inclusion Criteria:

* All with AFC ≤3,
* AMH;≤0.5
* and they give only ≤3 oocytes in their previous cycles

Exclusion Criteria:

-
Feasibility Study of a mHealth Platform for Remote Patient Monitoring of CKD and Peritoneal Dialysis Patients

The best treatment of Chronic Kidney Disease (CKD) is facilitated by early detection, when the progression of the disease can be slowed down or stopped. Early treatment focuses on diet, exercise, lifestyle changes, treating risk factors (diabetes, hypertension, etc.) and administration of medications supporting kidney functions. However, once the glomerular filtration rate dropped below 15 ml/min/1.73m2, treatment with dialysis or a kidney transplant is required. Dialysis treatments come with a huge lifestyle management and economic burden to the patients as well as the healthcare systems.

The challenges may be facilitated by usage of mobile applications that help the patients/caregivers and multidisciplinary team to manage the complexity of Peritoneal Dialysis (PD) treatment. Even though several mobile applications currently exist, they focus on certain limited aspects of health monitoring like diet or vitals and medical adherence like medication reminders. An application which would take a comprehensive all-in-one solution approach targeted towards managing kidney health is needed. The platform developed by AWAK Technologies consists of a Admin Portal, web-based Clinic Portal and a Patient Mobile Application. The App would allow patients/caregivers to enter treatment data related to their dialysis therapy, medication, symptoms and vital monitoring. It also allows them to communicate with their healthcare team via messaging and teleconsult.

The study aims to evaluate the feasibility of using this mHealth platform in the clinical setting. Additionally, the clinical investigation seeks to obtain data for further development of the mHealth platform that will better fulfil the needs of patients and healthcare professionals.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with CKD or on PD
* Treated at the Singapore General Hospital's Renal Clinic
* Able to read and understand English language well enough to independently follow instructions in the App and enter data in English
* Cognitively and physically capable and willing to interact with a digital device with internet access and perform self measurements
* Owns a digital device with internet access \[Apple/Android running on at least iPhone operating system (iOS) v13/Android v9\]

Exclusion Criteria:

* Living in an assisted facility, e.g., eldercare facilities, and hospices where their care is done/provided completely by healthcare professionals
* Patients or caregivers who have no access to digital device with internet access
* Patient has a severe comorbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the patient to be a good investigation candidate (i.e., other disease processes, mental capacity, substance abuse, shortened life expectancy, vulnerable patient population)
* The patient is currently involved in another clinical investigation where that participation may conflict or interfere with the treatment, follow-up or results of this clinical investigation
Impact of Urolithin A (Mitopure) on Mitochondrial Quality in Muscle of Frail Older Adults

The study is a single-center, randomized, placebo-control double-blind study in frail older adults over 65yrs. to investigate the impact of Mitopure (Urolithin A) supplementation on muscle mitochondrial quality in frail older adults after 8-weeks of supplementation


Eligibility Criteria:
Inclusion Criteria:

* Frail (as defined by the Fried frailty criteria)nonsmoking participants in the age group of 65 to 85 years old, both male and female.
* A body mass index between 18 to 35 kg/m2.
* Not on any medications/living with medical conditions that would compromise the study outcome or the safety of the research participant.
* Able to participate and willing to give written informed consent and to comply with the study restrictions.
* Willing to be assigned randomly either to the UA or the control group.

Exclusion Criteria:

Participants must not have:

* Participated in a clinical trial within 90 days of screening or more than 4 times in the previous year.
* A history (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol).
* A history or presence of allergy to 5-aminolevulinic acid or porphyrins.
* A history or presence of allergy to lidocaine.
* Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening.
* Unwillingness or inability to refrain from consuming alcohol within 48 hours before each visit until the end of said visit.
* Unwillingness or inability to refrain from consuming 8 or more units of xanthine containing beverages and foods per day during the entire study.
* Unwillingness to not consume other mitochondrial supplements during the course of the study (such as CoQ10, reseveratrol, NR, NMN etc.) and pomegranate juice
* unwillingness to not change diet or physical activity levels during the course of the study
* Unwillingness or inability to undergo a muscle biopsy.
* Underlying chronic disease, which in the opinion of the investigator, would interfere with study participation or the validity of the measurements.
* Unintentional weight loss ≤5% of regular body weight during the last 6 months.
* Medication requirements that may interfere with the interpretation of the results.
* Loss or donation of blood over 500mL three months prior (male subjects) or four months prior (female subjects) to participating in the study.
* Smoked (tobacco and/or marijuana mixed with tobacco (THC)) within 6 months prior to the start of the study;
* Abused drugs, medicine or alcohol within up to 30 days prior to the start of the study (Alcohol: more than 10 drinks a week, with more than 2 drinks a day most days; Drugs: THC, cocaine, opiates, amphetamines/methamphetamines, benzodiazepines, barbiturates, Buprenorphine, Creatin, Methadone metabolite, oxycodone, phencyclidine);
* A positive COVID-19 test taken 1 week to 24h before study start date.
Famotidine in Schizophrenia

Objective of the trial is to study if famotidine add-on treatment is more effective than placebo add-on in reducing symptoms of schizophrenia among patients receiving insufficient response to ongoing antipsychotic treatment.


Eligibility Criteria:
Inclusion Criteria:

* ICD-10 diagnosis of schizophrenia (F20.00-20.39, F20.5, F20.9) who have had the disorder for at least 5 years and who are on disability pension. (This means that their treatment response is not satisfactory and for the purpose of this study, the subjects are potentially treatment resistant).
* Clinical Global Impression (CGI) severity score of at least 3.
* No changes in schizophrenia treatment within 12 weeks before study inclusion.
* Written informed consent
* The subjects must fulfil schizophrenia criteria both according to DSM- IV (295.10, .20, .30, .60, .90) (American Psychiatric association) and the Research Diagnostic Criteria for schizophrenia (RDC) \[40\]. They must also have at least mild residual symptoms (CGI 3 points). The DSM-IV diagnosis will be verified by use of the SCID-I \[41\]. The DSM-IV is clearly the most commonly used in psychiatric research, so this is important to be able to generalize the findings. However, several previous studies have used the RDC, so to be able to compare the results, we will diagnose the patients according to both systems.
* Women of child-bearing age will be included only of they use adequate contraception, or if we can otherwise verify that the subject is not pregnant (s-HCG), the possibility of pregnancy is negligible (e.g. the personnel of the housing facility reports that the person has not had sexual relationships for years) and the subject approves to remain sexually abstinent for the duration of the study.

Exclusion Criteria:

* Epilepsy or a history of unclear seizures, stroke, Parkinson's disease, AIDS
* History of substance addiction or abuse within 3 months prior to enrolment.
* Individuals who are deemed at risk for aggressive behaviour or suicide
* If their laboratory tests, EKG or other clinical observation warrants exclusion, they will be excluded
* Women who are pregnant or breast-feeding subjects will not be included in the study.
* Patients with any serious unstable physical illness will also be excluded
* Patients who have been deemed to be legally incapacitated according to Finnish or Swedish law.
* Regular Uuse of H2-antagonists as prescribed by a physician.
* Known allergy to famotidine or any other component of interventional drug will be excluded.
* Ongoing treatment with clozapine and dixyrazine.
* Clinical condition "very much improved" or "much improved", assessed by CGI, during the placebo lead-in
* Renal insufficiency (P-creatinine not within normal range. Glomerular filtration rate \<30 ml/min according to the Cockcroft-Gault formula. )
* Liver insufficiency (S-ALAT elevated more than 2-fold above the laboratory specific normal range)
Comparison of Insulin Glargine Versus Biphasic Insulin Aspart 30/70 or Biphasic Insulin Aspart 30/70 in Combination With Metformin in Subjects With Type 2 Diabetes.

This trial is conducted in Asia. The aim of the trial is to compare the glycaemic control of Insulin glargine versus Biphasic Insulin Aspart 30/70 or Biphasic Insulin Aspart 30/70 in combination with metformin in subjects with Type 2 Diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Body mass index equal to or lesser than 35.0 kg/m2
* Currently treated with oral hypoglycaemic drug

Exclusion Criteria:

* Known hypoglycaemia unawareness or recurrent major hypoglycaemia as judged by the Investigator
* Any condition that the Investigator and/or the Sponsor feel would interfere with trial participation or evaluation of results