cyrilzakka/clinical-trials huggingface dataset:
CGM (Continuous Glucose Monitoring) Use in Diagnosis of Spontaneous and Reactive Hypoglycaemia

Use of CGM to determine diagnosis in possible spontaneous or reactive hypoglycaemia.

Use of CGM to aid treatment optimisation in spontaneous or reactive hypoglycaemia

The human body's blood sugar levels are tightly controlled by the hormone insulin, produced by the pancreas. If the pancreas produces too much insulin, then the blood sugar will fall to low levels (hypoglycaemia). Insulin overproduction can happen as a result of the body misreading a change in blood sugar levels after eating (such as after obesity surgery) or through tumours of the pancreas which overproduce insulin (insulinomas).

Hypoglycaemia can cause subtle symptoms such as tiredness, poor concentration, or dizziness and if untreated more severe symptoms including fits, coma and death. Low blood sugars can go unnoticed at night and if levels fall frequently, people can lose their ability to notice subtle symptoms.

People suspected of having hypoglycaemia require a series of investigations to try and reproduce a low blood sugar under controlled conditions. This often requires an admission to hospital for a few days and multiple finger pricks to test the blood sugar - which patients often find painful. If low blood sugars caused by too much insulin are confirmed then medical treatment is started in the first instance, with surgery possibly following later. The only way to check whether these medications are working is by home fingerprick glucose measurements. If people have low sugars at night or have lost their ability to notice symptoms of low blood sugar, it is very difficult to be sure that the medical treatment is working.

The investigators plan to use continuous glucose monitoring probes to measure patient's blood sugar prior to and during admission for formal investigation for hypoglycaemia (alongside conventional fingerprick and blood testing). This might allow us to exclude hypoglycaemia as a cause of their symptoms, avoiding lengthy admissions.

The investigators will also use this technology (alongside fingerprick testing) to test how well medical treatment is working in patients with proven hypoglycaemia.

Eligibility Criteria:
Inclusion Criteria:

* phase 1 - under investigation for possible/probable hypoglycaemia
* phase 2 - on medical therapy for established hypoglycaemia
* Must be Able and willing to give informed consent. No vulnerable adults will be included.
* Must be Aged \>18 years

Can be;

* Any ethnicity
* Any socio economic group
* Either conventional gender, or non-binary.

Exclusion Criteria:

* Must not be unwilling or unable to give consent
* Must not be unable to speak sufficient English to give consent and understand study requirements
* Must not be Aged\<18 or \>90 years
* Must not be lack capacity to consent
* Must not have an underlying hepatic condition
* Must not have a current excessive alcohol consumption (men regularly consuming \>50 units/week, women \>35 units/week)
* Must not have Diabetes Mellitus
* Must not be currently using Diabetic medication or insulin
* Must not be currently pregnant
* Must not be on haemo or peritoneal dialysis
Pharmacokinetics and Safety of Single-Dose Telbivudine in Children and Adolescents With Chronic Hepatitis B

This is a Phase I, open-label, single-dose study to evaluate the pharmacokinetics and safety of LDT600 in pediatric and adolescent patients with chronic hepatitis B infection.


Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents patients
* HBsAg seropositive

Exclusion criteria:

* Decompensated liver disease (Child-Turcotte-Pugh (CTP) Score≥7, Class B and C)
* Prior anti-HBV therapy within 30 days of study drug dosing.

Other protocol-defined inclusion/exclusion criteria may apply.
Infusion of Alloreactive nk Cells for Mrd-positive Aml Patients

This is a interventional, transplantation study. The procedure under study is the infusion of alloreactive NK cells in adult AML patients, eligible for ASCT, who achieved CR after conventional chemotherapy, but harbor MRD-positivity.

Haploidentical KIR-L mismatched donors will be included if present at least one allele mismatch at a class I locus among the following ones: HLA-C alleles with Asn77-Lys80, HLA-C alleles with Ser77-Asn80, HLA-Bw4 alleles. KIR-L mismatched donor alloreactive NK cell repertoire will be evaluated in order to determine the functional cell dose to be used for NK cell collection. Phenotypical analysis of KIRs will be correlated to functional tests. NK cells will be selected from a steady-state large volume leukapheresis product from a suitable haploidentical KIR-ligand incompatible donor. NK cell purification will be performed if the donor leukapheresis product contains at least 10x106 NK cells/Kg.

Immunomagnetic enrichment of NK cells will follow two subsequent steps: 1) depletion of CD3+ T cells followed by 2) positive selection of CD56+ NK cells.

Patients will receive immunosuppressive chemotherapy, fludarabine (Flu) 25 mg/mq/ from day -5 to -3 and cyclophosphamide (Cy) 2 g/mq on day -2 (Flu/Cy). Two days after Cy administration, patients will be infused intravenously with a single dose of cryopreserved NK cells (day 0), which will be followed by subcutaneous administration of IL-2 (10 x 106 IU/day, 3 times weekly) for 2 weeks (6 doses total). PB samples will also be collected for biological studies. In particular, PB samples will be collected for molecular assessment of microchimerism and tracking of haploidentical NK cells for 30 days, immunophenotype studies, alloreactive NK cells cloning and functional assays (cytotoxicity). Enrolled patients will be followed up for at least 12 months after NK cell infusion.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of de novo or secondary AML
* Age ≥ 18 years
* Morphologic CR
* Eligibility for ASCT
* MRD-positivity after induction chemotherapy
* Availability of a KIR-L incompatible haploidentical donor
* Performance Status ≥ 70% (Karnofsky score) or ≤ 2 (WHO).
* Adequate renal (serum creatinine \< 2 mg/dl), pulmonary (Sat O2 ≥ 96%) and hepatic (ALT/AST \< 2.5 x N) function.
* Left Ventricular Ejection Fraction (LVEF) of \>50% as determined by Echocardiogram (ECHO).
* Signed informed consent.

Exclusion Criteria:

* Diagnosis of AML FAB M3
* HIV positivity.
* HCV positivity with high viral load.
* Pregnant or nursing females.
* Current uncontrolled infection.
* Signs or symptoms of fluid retention (e.g. pleural effusion).
Bone Marrow Transplant Trial for Patients With Refractory Severe Aplastic Anemia

Patients with severe, refractory aplastic anemia have a severe, life threatening disease in their bone marrow. Refractory disease means that disease has come back or not responded after receiving one or more immunosuppressive treatments. High dose chemotherapy followed by bone marrow transplantation (BMT) has been used to treat blood diseases like aplastic anemia but complications from Graft vs Host disease (GVHD) and graft failure have limited the survival for those patients.

Another study done here at Johns Hopkins has shown that in patients with other diseases (blood cancers) some immunosuppressive drugs given after the BMT has decreased how often patients had complications of GVHD and engraftment failure.

This research is being done to find if this approach will help patients with aplastic anemia who have failed other treatments will have better outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have refractory or relapsed SAA following treatment with one or more immunosuppressive regimens.
* Age 6 months - 70 years
* Patients must meet medical criteria for myeloablative BMT
* Patients or their parents/guardians and donors must be able to sign consent forms.
* Patients must be geographically accessible and willing to participate in all stages of treatment.

Exclusion Criteria:

* Poor cardiac function: left ventricular ejection fraction \<45% as determined by MUGA or ECHO.
* Poor pulmonary function: FEV1 and FVC \<50% predicted.
* Poor renal function
* Positive leukocytotoxic crossmatch
* Women of childbearing potential who currently are pregnant (Β-HCG+) or who are not practicing adequate contraception
* Uncontrolled viral, bacterial, or fungal infections
Better in Better Out Cystectomy.

The current gold standard for non-metastatic muscle-invasive bladder cancer or treatment-refractory high-risk non-muscle-invasive bladder cancer is radical cystectomy (RC). This procedure is associated with high rates of perioperative complications (30-65%) and mortality (1.5-10%). Patients who require radical cystectomy often present with multiple co-morbidities, a certain degree of frailty, functional deficits, and a high level of past or current tobacco use. According to the "better in, better out" principle, it is likely that by improving the physical, nutritional and psychological status, a reduction in morbidity and mortality will be observed.

The literature suggests that multimodal prehabilitation may reduce complications and improve functional recovery after major cancer surgery. Therefore, the prehabilitation programme used in this study includes exercise training, dietary advice, psychological support and smoking cessation advice. Prehabilitation has been offered to a selection of patients with increased risk for postoperative complications since 01/05/2023.

At ZOL Genk, patients receive preparation for RC in one of three ways, depending on a balancing exercise that considers the patient's complexity and frailty, functionality, mobility and other factors. Patient preference and place of residence are also taken into account in determining the most appropriate preparation pathway. 1. The patient is solely encouraged to increase his fitness level by means of independent aerobic exercise. 2. The patient receives a prescription for primary care physiotherapy in his own area. 3. The patient undergoes our full internal prehabilitation program. The primary objective of this study is to compare these three different groups in terms of mortality, ICU length of stay, length of hospital stay, complication rate, type of complications and readmission rate. Finally, patient adherence will be examined.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed primary bladder cancer (cTa-4N0-3M0) who underwent RARC.

Exclusion Criteria:

* Patients who needed a semi-urgent cystectomy.
* Patients with severe cognitive or psychiatric impairment.
* Patients with a contraindication to perform physical exercise training or a cardiopulmonary exercise test (CPET).
* Metastatic or non-primary disease.
Personalizing Window of Implantation During Frozen Embryo Transfer

Embryo implantation is a crucial event in the establishment of a pregnancy. Although the clinical and culture conditions to obtain a "good quality" embryo are well advanced today, endometrial receptivity remains a major barrier in assisted reproductive techniques. Once a high-quality embryo is transferred, impaired uterine receptivity is believed to be one of the major reasons behind failure of the establishment of pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 18 to 40 inclusive at the time of oocyte retrieval
* Prescription of a single frozen embryo transfer - substituted cycle protocol
* Participant has at least 2 vitrified good quality blastocysts

Exclusion Criteria:

* Women undergoing fertility preservation
* Stage IV severe endometriosis
* Severe malformation, adenomyosis or uterine anomaly including fibroids deforming the uterine cavity ≥ 5 cm
* Positive results of screening for either participant or partner for HIV antibodies, Hepatitis B (other than surface antibodies present after vaccination) or Hepatitis C
Impact of Emotional Mimicry and Oxytocin on Frontotemporal Dementia

This study will evaluate the effects on emotions and neural activity of a one time dose of intranasal oxytocin vs. placebo in patients with FTD and healthy controls.

Frontotemporal dementia (FTD) and Pick's disease cause changes in personality, behaviour, and emotional responses. The usual treatments for Frontotemporal dementia focus on reducing agitation and aggressive behaviours. However, these drugs do not help all patients who experience blunting of emotion and loss of empathy. This study will evaluate the effects on emotions and neural activity of a one time dose of intranasal oxytocin vs. placebo in patients with FTD and healthy controls.

Eligibility Criteria:
Inclusion Criteria:

Patients:

* Ages 30-85
* meet consensus criteria for probable behavioural variant FTD (bvFTD)

Controls:

* Age and sex matched with patients
* Mini-Mental State Exam (MMSE) scores \>27

Exclusion Criteria:

Patients:

* history of stroke
* intracranial haemorrhage or other medical or neurological disorder apart from FTD that could affect cognition
* diagnosis of bipolar disorder or schizophrenia not better accounted for by the diagnosis of FTD
* cognitive impairment that precludes comprehension of task instructions
* contraindication to MRI scanning
* severe language or memory deficits that preclude participation in the study visits and measures
* females who are pregnant or breastfeeding (a pregnancy test will be done on females who have not completed menopause).
* uncontrolled hypertension
* bradycardia (rate \<48 bpm) or tachycardia (rate \> 100 bpm)
* current use of prostaglandins

Controls:

* history of stroke
* intracranial haemorrhage or other medical or neurological disorder
* diagnosis of bipolar disorder or schizophrenia
* cognitive impairment that precludes comprehension of task instructions
* contraindication to MRI scanning
* severe language or memory deficits that preclude participation in the study visits and measures
* females who are pregnant or breastfeeding (a pregnancy test will be done on females who have not completed menopause).
* uncontrolled hypertension
* bradycardia (rate \<48 bpm) or tachycardia (rate \> 100 bpm)
* current use of prostaglandins
Determining the Physiological Mechanisms Behind the ObeEnd Device on Factors Regulating Appetite

In Canada, over 60% of adults are classified as overweight and obese resulting in a public health crisis including increasing health care costs and negatively impacting the well-being of many Canadians. To overcome these barriers, the ObeEnd device, manufactured by WAT Medical Enterprise, is a new and innovative wellness technology that uses electrical pulses to stimulate acupressure point PC6 to help control appetite. PC6 stimulation could potentially modulate appetite and restore gastric dysfunction, which are important factors that contribute to obesity. If PC6 electrostimulation facilitates the normalization of appetite and restoration of gastric dysfunction in those with obesity, then the device could be a potentially helpful aid to weight loss.

To measure the change of appetite hormones and enzymes related to appetite regulation after using the ObeEnd device. The investigators hypothesize that, compared to placebo, electrostimulation of PC6 an acupuncture spot on the wrist over a two-week period will result in changes in enterogastic hormones in a direction that decreases appetite. The investigators also hypothesize that these changes will not affect physical activity levels but will correspond to changes in appetite and diet. This study will provide the first evidence of the effects of electrostimulation at PC6 on factors affecting body weight regulation providing insight into the utility of the ObeEnd device for weight control.


Eligibility Criteria:
Inclusion Criteria:

* BMI \>30 kg/m2
* no history of chronic illness or disease
* premenopausal

Exclusion Criteria:

* pregnant, breastfeeding
* medications that may affect outcomes
* chronic disease or conditions that may affect outcomes
* smoking or use of nicotine containing products
MINIject Glaucoma Implant in European Patients

The study will evaluate the efficacy and safety of the MINIject glaucoma implant and Intraocular Pressure (IOP) lowering effects with or without glaucoma medications. The procedure will be a stand-alone surgery. Overall, the patient will be asked to perform several examinations up to 24 months after surgery.

The primary endpoint is the 'qualified success' rate at 6 months after surgery greater than 60%. 'Qualified success' is defined as a diurnal IOP ≤ 21mmHg (millimeter mercury) and \> 5mmHg with a minimum 20% diurnal IOP reduction from baseline with or without the concomitant use of allowed glaucoma hypotensive medication at 6 months after surgery

Eligibility Criteria:
Inclusion Criteria:

* Males or females, 50 years of age or older.
* Diagnosis of primary open angle glaucoma during screening visit or earlier.
* Grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to Shafer Angle Grading System.

Exclusion Criteria:

* Diagnosis of glaucoma other than primary open angle glaucoma (e.g. angle closure glaucoma or secondary open angle glaucoma) in the study eye.
* Grade 2 (narrow, 20 degrees), grade 1 (extremely narrow, less or equal to 10 degrees) and grade 0 (closed or slit) according to Shafer Angle Grading System.
* Neovascular glaucoma in the study eye.
* Corneal opacity or iridocorneal angle not visible through gonioscopy prisma in the study eye, preventing correct placement of the implant.
Post-operative Outcomes in the Pyloromyotomy Procedure Under Spinal Anesthesia

Infantile hypertrophic pyloric stenosis (HPS) is one of the most common gastrointestinal medical emergencies.This retrospective study will review the files of all infants with HPS, who were treated by open pyloromyotomy under spinal anesthesia in the Bnai Zion Medical Center between the years 2006 to 2015.

Infantile hypertrophic pyloric stenosis (HPS) is one of the most common gastrointestinal medical emergencies that occur during the first 2 months of life.

Anesthetic induction and airway management of infants with HPS can be challenging because of the accumulation of significant volumes of gastric content, predisposing these patients to pulmonary aspiration during the induction of general anesthesia Despite the correction of systemic metabolic alkalosis, cerebrospinal fluid can remain alkalotic, and in this context hyperventilation and opioids may increase the risks of post-operative central apnea. All of the above anesthetics risks urged some anesthetists to alternatively use spinal anesthesia (SA) in infants undergoing pyloromyotomy.

This anesthetic technique proved to be both safe and efficient in infants undergoing pyloromyotomy, in addition to decreasing the mentioned risks associated with the other techniques.

This retrospective study will review the files of all infants with HPS, who were treated by open pyloromyotomy under SA in the Bnai Zion Medical Center between the years 2006 to 2015. It is designed to evaluate the postoperative full enteral feeding time, pain management and the incidence of post-operative apnea, the incidence of substantial vomiting episodes and other spinal anesthesia complications as secondary outcomes in infants undergoing pyloromyotomy under spinal anesthesia.

Eligibility Criteria:
Inclusion Criteria:

Infants with Hypertrophic Pylorostenosis, treated by open pyloromyotomy under Spinal Anesthesia

Exclusion Criteria:

Infants with Hypertrophic Pylorostenosis,treated by open pyloromyotomy under General Anesthesia
Postoperative Follow up After Head and Face Reconstructive Surgeries

In this observational follow-up study, patients with type III-IV head and face soft tissue deformities/defects following reconstructive surgeries will be asked to fill out 3 questionnaires, either through phone calls or video calls, in order to evaluate the post-operative outcomes such as morphological and functional recovery, quality of life and patients' return to the community.

The objective of this follow up study is to evaluate the effectiveness and to analyze the limitations of the existing management and treatment of severe burn injuries. Investigation of the factors affecting the recovery and patients' return to the community in patients with severe burn injury may lead to effective amendments of the existing management, and thus aiding in the development of an integrated diagnosis and treatment guidelines.

Eligibility Criteria:
Inclusion Criteria:

1. Preoperative facial soft tissue deformities/defects of type III and IV
2. Major reconstructive surgery of the head and neck (flap transfer with revision at least once) performed before January 1, 2019.
3. Agreed and able to cooperate with the follow-ups, with signed informed consent form or audio recorded informed consent.

Exclusion Criteria:

1. Patients with mental illness, reduced cognitive capacity, unable to consent and unable to cooperate.
2. Minor patients without legal guardian.
3. Not willing to participate; informed consent form not signed.
To Evaluate the Efficacy and Safety of TQC3564 Tablets in the Treatment of Persistent Allergic Rhinitis

A clinical study to evaluate the efficacy and safety of tqc3564 tablets in the treatment of persistent allergic rhinitis. A total of 24 patients will be enrolled.


Eligibility Criteria:
Inclusion Criteria:

* Age 18\~65 years old, male or female;
* Meet the clinical diagnostic criteria for allergic rhinitis, and the diagnosis is based on the "Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2015, Tianjin)" issued by the Rhinology Group of the Otolaryngology Head and Neck Surgery Branch of the Chinese Medical Association:

  1. Symptoms: sneezing 2 or more symptoms, such as watery mucus, nasal itching and nasal congestion, persist or accumulate for more than 1 hour per day, and may be accompanied by eye symptoms such as itching, watering and redness;
  2. Signs: Pale and edema of the nasal mucosa is common. Nasal watery secretions;
  3. Allergen test: at least one allergen SPT and/or serum-specific IgE positive (test results within 12 months before screening);
* Female subjects of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; negative serum pregnancy test within 14 days before study enrollment , and must be non-lactating subjects; male subjects should agree to use contraception during the study period and for 6 months after the end of the study period.
* The subjects voluntarily joined the study, signed the informed consent, and had good compliance.

Exclusion Criteria:

* Patients with non-allergic rhinitis, such as drug-induced rhinitis, vasomotor rhinitis, non-allergic rhinitis eosinophilic rhinitis, etc.; patients with severe nasal septum deviation, sinusitis, nasal polyps, hypertrophic rhinitis Other nasal organic lesions;
* In the nasal examination at the end of the screening period or the introduction period, there is any erosion of the nasal mucosa, septal ulcer or perforation of the nasal septum;
* Those who have undergone sinus surgery within 3 months before the screening period or who have not fully healed the nasal wound;
* The subject has uncontrolled diabetes mellitus, that is, fasting blood glucose (FBG) \> 10mmol/L in the laboratory test during the screening period;
* History of allergy to any study drug or similar chemical drugs (CRTh2 antagonists);
* History of severe allergic reaction to any allergen, such as anaphylactic shock or life-threatening asthma, previous intubation, respiratory arrest, hospitalization for asthma or acute asthma attack within the past 3 months;
* Those who were found to respond to placebo during the lead-in period (with rhinitis symptoms of moderate or above during the screening period, those with mild or no symptoms during the lead-in period, or baseline rTNSS mean \<6 points were defined as placebo responders;
* Women who are pregnant or breastfeeding, or who plan to become pregnant or breastfeeding during the study period;
* Any subject deemed unsuitable for participation in this clinical study by the investigator.