cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Effect of Cetuximab on Corrected QT (QTc) Interval Changes in Patients With Advanced Malignancies From Solid Tumors

The purpose of this study is to determine whether corrected QT (QTc) interval changes occur on an electrocardiogram (ECG) when cetuximab is administered to the study population.


Eligibility Criteria:
Inclusion criteria:

* Advanced or metastatic malignant disease originating from solid tumors
* Adequate recovery from previous therapy or intervention; at least 21 days since major surgery or prior radiation therapy
* Measurable or evaluable disease

Exclusion criteria:

* Women of childbearing potential (WOCBP) who are breastfeeding, pregnant, or unwilling or unable to use acceptable contraception during the study and for at least 12 weeks after the last on-study dose of cetuximab
* Men unwilling to use acceptable contraception during the study if engaged in sexual relations with a WOCBP
* Symptomatic brain metastasis
* History of myocardial infarction 6 months or less prior to study entry, of severe congestive heart failure, of uncontrolled angina, or of uncontrolled arrhythmias
* Clinically relevant abnormality on screening electrocardiogram (ECG), preventing an accurate measurement of the QT interval
* Congenital long QT syndrome
* History of risk factors for ventricular tachycardia or Torsades de pointes or history of fainting, unexplained loss of consciousness, or convulsions
* Prolonged QTc interval on screening ECG (greater than 470 msec) using Fridericia's correction formula
* Heart rate slower than 50 bpm or faster than 100 bpm at rest during screening ECG measurements
* Implantable pacemaker or automatic implantable cardioverter defibrillator
* Sustained supine systolic blood pressure higher than 150 mmHg or lower than 90 mmHg or a diastolic blood pressure lower than 45 mmHg or higher than 95 mmHg at screening
* Known history of arterial thrombotic events within 6 months prior to study initiation
* Known history of significant peripheral artery disease
* Current participation in a clinical trial with another investigational new drug or device
* Receipt of an investigational new drug or device within 21 days prior to enrollment in this study
A Phase II Study of CRT Combined With QL1706 in ESCC Patients

This is a single arm, multi-center Phase II Study. This clinical study is an investigator-initiated clinical trial（IIT). The objective of this study is to evaluate the efficacy and safety of Chemoradiationtherapy combined with QL1706 (anti-CTLA-4 and PD-1 antibody) in patients with unresectable locally advanced esophageal squamous cell carcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects participate voluntarily and sign informed consent.
2. age:18-75 years, male or female.
3. Histologically confirmed Advanced Unresectable Esophageal Squamous Cell Carcinomas,unresectable of clinical stage II-IVa patients (include unresectable,or surgical contraindication or refuse surgery)(According to AJCC 8th Edition stage , Pre-treatment clinical stage cT1N2-3M0,cT2-4bN0-3M0.
4. At least 1 measurable target lesion and/or unmeasurable target lesion according to Response Evaluation in Solid Tumors (RECIST 1.1).

Exclusion Criteria:

1. Patients who have a history of esophageal cancer surgery.
2. Previous history of fistula caused by primary tumor infiltration.
3. a high risk of gastrointestinal bleeding, esophageal fistula or esophageal perforation.
4. Subjects with poor nutritional status and weight loss of ≥ 10% in the first 2 months of screening have no significant improvement after nursing intervention.
5. Major surgery or serious trauma within 4 weeks before the first use of the study drug.
Effect of Sourdough Bread Consumption on Postprandial Responses, Appetite Regulation and Energy Intake

During this project the effect of yeast bread and sourdough breads consumption on satiety, energy intake at subsequent meal and postprandial metabolic responses, will be investigated.

The primary aim of this study will be to evaluate the impact of an alternative starter culture that produces high levels of lactic acid on appetite regulation (subjective satiety and energy intake at the subsequent meal). The second aim will be to identify mechanistic parameters that may explain the observed effects, including glycaemic and insulin response, and gastric emptying rate. In addition, habitual physical activity levels, and mood and stress levels of the subjects will be evaluated as potential covariates of appetite regulation.

It is hypothesized that:

Sourdough breads fermented with the alternative starter culture that produce high concentrations of lactic acid will reduce glucose response via lower starch digestibility and/or slower gastric emptying rate. The reduced glycaemic response will lead to higher satiety and lower energy intake at the subsequent meal (more than 10%).

Eligibility Criteria:
Inclusion Criteria:

* Female and male participants
* age range 18 - 50
* BMI range 18.5 - 25.0 kg/m2 at screening visit
* Regular eating pattern (3 meals per day on at least 5 days per week)
* Stable body weight for the last 6 months

Exclusion Criteria:

* Currently smoking (has smoked in the last 28 days) or willingness to smoke during the study period
* Pregnancy, lactation or wish to become pregnant during the study period
* Family history of diabetes
* Previous or current gastrointestinal or endocrine disorders
* Previous or current substance/alcohol dependence or abuse (\> 2 units per day/14 units per week)
* Coeliac disease or gluten sensitivity
* Use of pre- or probiotics within one month preceding the study
* Use of antibiotics within 3 months preceding the study
* Excessive concern about eating habits or body weight as evidenced from scores \< 18 on the restraint and disinhibition subscales of the Three-Factor Eating Questionnaire (Stunkard \& Messick, 1985)
Functional Impact of a Memory Intervention Program

Normal aging is associated with decline in some aspects of memory, and this can be a risk factor for reductions in everyday functioning. The Baycrest Memory and Aging Program teaches positive adaptation to age-related memory changes, including strategies for minimizing the everyday impact of normal memory change and positive lifestyle change to maximize brain health. Prior research has shown that the Memory and Aging program is effective in increasing participants' knowledge about memory, use of memory strategies, and confidence in memory function, as well as adoption of healthier lifestyle practices and reduction in intention to use unneeded health care resources.

Although not one of the stated goals of the program, informal feedback from participants suggests that the educational content and skills training in the Memory and Aging Program has led some participants to change behaviours in ways that lead to significant improvements in their everyday functioning. For example, graduating participants often volunteer examples of how they have applied what they have learned to succeed in everyday memory tasks such as learning a new name or keeping track of future plans. Based on this participant feedback, it is hypothesized that the knowledge, skills, and confidence gained by Memory and Aging Program participants may lead to positive behaviour changes that, in turn, lead to improved everyday functioning. The present study will test this hypothesis using a randomized controlled pretest-posttest design.


Eligibility Criteria:
Inclusion Criteria:

* Age 50-90
* Available to participate in all testing and intervention sessions (located in Toronto, Canada)

Exclusion Criteria:

* health conditions with major effects on cognition, including a current or previous history of stroke, brain surgery, or diagnosed neurological disorder
* dependence in instrumental activities of daily living
* cognitive impairment, defined as performance below cutoff for cognitive impairment on a standardized cognitive test, the Telephone Interview for Cognitive Status (Brandt, Spencer, \& Folstein, 1988).
* affective impairment, defined as performance below cutoff for depression on standardized depression screen, the Geriatric Depression Scale (Yesavage et al., 1983)
Relation Between Ethanol Sclerotherapy for Endometrioma Systemic Immune Milieu

Design: Prospective interventional study. 69 women with OE were evaluated clinically and by transvaginal ultrasonography (TUV). AEST procedure was performed and the collected aspirate and pre-procedural blood samples were collected for estimation of cytokines' levels. At 6-m post-procedure, clinical evaluation and TUV were repeated and serum cytokines' levels were re-estimated.


Eligibility Criteria:
Inclusion Criteria:

* Women with OE of a mean diameter of \>3 cm

Exclusion Criteria:

* Women with recurrent OE
* a cyst that was suspicious of being malignant
* diabetes mellitus
* polycystic ovary syndrome
* body mass index (BMI) of \>30 kg/m2
* previous surgical interference that resulted in pelvic adhesions
Comparing Analgesic Effects of Caudal and Erector Spinae Plane Blocks in Pediatrics Undergoing Upper Abdominal Surgery

Upper abdominal surgeries are painful and pediatric patients who undergo these operations require effective postoperative pain control. Epidural and caudal blocks are considered to be the gold standard regional analgesia techniques. Currently, ultrasound guidance is commonly used for caudal block performances to demonstrate the cannula placement and the deposition of local anesthetic. Additionally, erector spinae plane block can be a safer alternative for blocking the similar dermatomes. In this study, the aim is to compare postoperative analgesic effects of these two ultrasound-guided techniques in pediatric patients. The primary outcome of this study is the follow-up of FLACC/VAS pain scores. Secondary outcomes are time to first analgesic requirement, number of patients who require rescue analgesic, possible side effects, time to first mobilization, length of hospital stay and chronic pain due to incision after 2 months.

Upper abdominal surgeries are painful and pediatric patients who undergo these operations require effective postoperative pain control. Blockade of dermatomes between T6 and L1 commonly provides effective postoperative analgesia. Epidural and caudal blocks are considered to be the gold standard regional analgesia techniques as they provide both somatic and visceral analgesia. Currently, ultrasound guidance is commonly used for caudal block performances to demonstrate the cannula placement and the deposition of local anesthetic. Additionally, erector spinae plane block can be a safer alternative for blocking the similar dermatomes. In the present study, the aim is to compare postoperative analgesic effects of these two ultrasound-guided techniques in pediatric patients undergoing upper abdominal surgery. The primary outcome of this study is the follow-up of FLACC/VAS pain scores. Secondary outcomes are time to first analgesic requirement, number of patients who require rescue analgesic, possible side effects (nausea, vomiting, itching, urinary retention, bradycardia, hypotension, respiratory depression), time to first mobilization, length of hospital stay and chronic pain due to incision after 2 months.

Eligibility Criteria:
Inclusion Criteria:

* undergoing upper abdominal surgery
* ASA(American Society of Anesthesiology)1-2

Exclusion Criteria:

* denial of patient or parents
* infection on the local anesthetic application area
* infection in the central nervous system
* coagulopathy
* brain tumors
* known allergy against local anesthetics
* anatomical difficulties
* with preexisting cardiac dysfunction
* with history of renal and/or hepatic dysfunction
Higher Dose of Alglucosidase Alpha for Pompe Disease

This study is aimed to investigate that whether the higher dose ERT improve safety and clinical outcomes of Pompe disease patients. Also, wish to develop a new therapeutic recommendation and hope that it could improve the long-term outcomes of Pompe diesease patients.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Pompe disease
2. Currently receiving ERT with regular clinic visits
3. Agree to sign informed consent

Exclusion Criteria:

1. Lost follow-up for clinical visits
2. Allergy to Myozyme
3. Refuse to sign informed consent
Non-invasive Neurally Adjusted Ventilator Assist or Continuous Positive Airway Pressure in Preterm Infants

Strategies to prevent lung injury, facilitate lung development, and to support the preterm infant's capacity to breathe are decisive. Continuous positive airway pressure (CPAP) is the gold standard in non-invasive breathing support in preterm infants with a positive pressure that keeps the alveoli slightly inflated during expiration. Non-invasive neurally adjusted ventilator assist (NIV NAVA) is a novel method of breathing support and uses the electrical activity from the diaphragm to trigger the ventilator and synchronize with the breathing cycle. During NIV NAVA the preterm infant controls the onset of the inspiration, the respiratory rate, inspiratory time and peak pressure. This method has the potential to improve the positive pressure transmission to the infant's lower airways, accurate synchronization with the breathing pattern and be a comfortable breathing support system for the preterm infant.

The investigators will compare the effect on breathing effort in preterm infants during continuous positive airway pressure and non-invasive neurally adjusted ventilatory assist measured by electrical activity in the diaphragm, respiratory vital signs, systematic clinical scoring of breathing effort and comfort, and parent reported outcomes.

This is a randomized cross-over study with AB/BA sequences. The infants will receive both interventions in 4 hours intervals, a 30 minutes period to change the breathing support and a 30 minutes wash out period between interventions. Initially positive end expiratory pressure are set to 5 cm H2O and can be adjusted up to 7 cm H2O if needed decided by the medical team for both interventions. The neurally adjusted level will be set to obtain average Edi peak \< 15 microvolt. Back-up setting and apnea time in the ventilator assist intervention (NIV NAVA) will be individualized according to clinical parameters in each preterm infant.

Modification approved by ethical committee REK 2021, 6th of August:

After two hours in each intervention, the nurse responsible for the infant will perform the clinical scoring. In addition it will be investigated if there is a difference in respiratory vital signs during skin to skin care and in the incubator. During each intervention period, the preterm infants are placed on the parent's chest skin to skin for at least one hour.

A modified version of the scoring tool will be used, i.e. without the item of nasal flaring and expiratory grunting. The headgear for CPAP and NIV NAVA covers parts of the nose and makes nasal flaring difficult to observe.

Eligibility Criteria:
Inclusion Criteria:

* spontaneously breathing preterm infants 24 to 96 hours old
* gestational age (GA) between week 28+0 and 31+6
* preterm infants with GA \< 28+0 with a postmenstrual age (PMA) \> 28 weeks
* at least 72 hours old treated with CPAP or NIV NAVA

Exclusion Criteria:

* preterm infants with severe congenital malformation
* need for vasopressors
* preterm children in need of a specific respiratory support system due to medical reasons
The Effect of Micellized Food Supplements on Health-related Quality of Life in Patients With Post-acute COVID-19 Syndrome.

Food supplements like curcumin and boswellia serrata have been used traditionally for anti-inflammatory purposes. A well-known problem of these substances in their natural form is the low bioavailability. Micellization of these substances has been shown to increase the bioavailability significantly and thereby the clinical efficacy. The clinical value of these micellized substances has been presented in numerous clinical studies and in particular in patients with acute COVID-19. This study aims to examine the effect of a mixture of micellized curcumin, boswellia serrata and ascorbic acid on patients with long COVID.

The participants will be asked to take the micellized supplements daily, at home for 6 weeks. During this 6 weeks several questionnaires will be taken to asses general health-related quality of life. Follow-up measurements will be done at 14 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed SARS-CoV-2 infection at least 28 days prior to study participation
* Patients who are experiencing symptoms of PACS (with a PCFS of 1 or higher)
* 18 years or older and younger than 85
* Good understanding of written German

Exclusion Criteria:

* Currently under pharmacological treatment for PACS
* Any planned medical surgery or intervention where medication intake is necessary in the coming 14 weeks
* Allergy to curcumin or Boswellia
* Active malignancy
* Medical history of Human Immunodeficiency Virus (HIV) infection, or any serious immunocompromised state.
* Pregnancy (or planned pregnancy in the coming 14 weeks) ( - Patients who are taking anticoagulants or have diabetes type I or II are only allowed to participate if their general practitioner is informed)
A Study to Evaluate the Safety of Paricalcitol Capsules in Pediatric Subjects Ages 10 to 16 With Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis

The objective is to evaluate the safety of paricalcitol capsules in pediatric subjects, ages 10 to 16 years old, with Stage 5 chronic kidney disease (kidney failure) receiving peritoneal dialysis or hemodialysis and being treated for secondary hyperparathyroidism. Subjects will be in the dosing period of the study for 12 weeks in order to evaluate the incidence of hypercalcemia (high calcium levels in blood). Approximately 12 subjects will be enrolled and all 12 will receive paricalcitol capsules.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be receiving peritoneal dialysis or hemodialysis for at least 3 months prior to Screening
* Subject is currently being diagnosed and/or treated for secondary hyperparathyroidism
* For entry into the Dosing Period (for subjects that are naïve to Vitamin D Receptor \[VDR\] Activators or those who have completed a 2 to 12 week washout), the subject must meet the following laboratory criteria prior to enrollment:

  * A corrected calcium value ≥ 8.2 and ≤ 10.4 mg/dL
  * A phosphorus value ≤ 6.5 mg/dL
  * An intact parathyroid hormone (iPTH) value \> 300 pg/mL and less ≤ 2000 pg/mL

Exclusion Criteria:

* Subject is expected or scheduled to receive a living donor kidney transplant within 3 months of Screening or is a kidney transplant patient requiring full immunosuppressant therapy
* Subject is expected to stop peritoneal dialysis or hemodialysis within 4 months of Screening (per investigator discretion)
* Subject has had a parathyroidectomy within 12 weeks prior to Screening
* Subject has had symptomatic or significant hypocalcemia requiring VDR Activator therapy (i.e., calcitriol, paricalcitol, or doxercalciferol) within 2 months prior to Screening
* Subject is taking maintenance calcitonin, bisphosphonates, glucocorticoids in an equivalent dose of greater than 5 mg prednisone daily, or other drugs known to affect calcium or bone metabolism within 4 to 8 weeks prior to Dosing
* Subject is receiving cinacalcet at the time of Screening
A Trial on Clinical Efficacy of 1% Versus 2% Lignocaine in Cough Suppression and Pain Relief in Patients Undergoing Flexible Bronchoscopy

Flexible bronchoscopy is a common procedure performed by pulmonary physicians. The use of topical anesthesia, analgesia, and sedation during flexible bronchoscopy varies among physicians, institutions and geographic locations across the globe. Commonly used topical anesthetic agents before and during bronchoscopy include cocaine (4%),benzocaine (20%), tetracaine (1%), and lignocaine (1%-10%). Topical lignocaine is administered through the flexible bronchoscope in an attempt to reduce excessive coughing and patient discomfort. However, the optimal dosage and strength of topical lignocaine that should be used during fibreoptic bronchoscopy has long been a topic of controversy. In this study we compare the efficacy of 1% versus 2% lignocaine in controlling cough and pain in patients undergoing flexible bronchoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients undergoing flexible bronchoscopy
* Hemodynamic stability

Exclusion Criteria:

* Patients receiving sedatives during the course of their treatment
* Patients undergoing conventional TBNA and/or EBUS-TBNA who are likely to receive sedation
* Patients with known hypersensitivity to lignocaine
* Not willing to provide informed consent
Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis

To evaluate the safety and effectiveness of fluconazole as an intravenous dose as initial treatment for acute cryptococcal meningitis followed by oral therapy in AIDS and non-AIDS patients. Both newly diagnosed and relapsed patients are eligible. The effectiveness of maintenance fluconazole therapy in sustaining a clinical cure in AIDS patients will also be evaluated.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Antivirals such as zidovudine. Prophylaxis for Pneumocystis carinii pneumonia. Aerosolized pentamidine.

Concurrent Treatment:

Allowed:

* Radiation therapy for mucocutaneous Kaposi's sarcoma.

Written informed consent must be obtained for each patient, either from the patient himself or from the patient's legal guardian.

* Patient's treatment status must be one of the following:
* No prior systemic antifungal therapy for cryptococcosis.
* Relapse after prior therapy. The success of prior therapy must have been documented by negative CSF culture at the end of therapy. Following prior therapy, such patients may not have received more than 1 mg/kg/wk amphotericin B in the 4 weeks before entry into the study.

Prior Medication:

Allowed:

* Antivirals such as zidovudine (AZT). Prophylaxis for Pneumocystis carinii pneumonia. Aerosolized pentamidine.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
* A history of allergy to or intolerance of imidazoles or azoles.
* Moderate or severe liver disease defined by specified lab values.
* Life expectancy of \< 2 weeks.

Concurrent Medication:

Excluded:

* Coumarin-type anticoagulants.
* Oral hypoglycemics.
* Barbiturates.
* Phenytoin.
* Immunostimulants.
* Investigational drugs or approved (licensed) drugs for investigational indications except aerosolized pentamidine.

Concurrent Treatment:

Excluded:

* Lymphocyte replacement.

Patients with the following are excluded:

* Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
* A history of allergy to or intolerance of imidazoles or azoles.
* Moderate or severe liver disease defined by specified lab values.
* Life expectancy of \< 2 weeks.

Prior Medication:

Excluded:

* Coumarin-type anticoagulants.
* Oral hypoglycemics.
* Barbiturates.
* Phenytoin.
* Immunostimulants.
* Investigational drugs or approved (licensed) drugs for investigational indications except aerosolized pentamidine.

Prior Treatment:

Excluded:

* Lymphocyte replacement.