cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema

This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of diabetes mellitus (Type 1 or Type 2)
* Hemoglobin A1c (HbA1c) of less than or equal to (≤)10% within 2 months prior to Day 1
* Macular thickening secondary to diabetic macular edema (DME) involving the center of the fovea
* Decreased visual acuity attributable primarily to DME
* Ability and willingness to undertake all scheduled visits and assessments
* For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods that result in a failure rate of \<1% per year during the treatment period and for at least 3 months after the final dose of study treatment

Exclusion Criteria:

* Currently untreated diabetes mellitus or previously untreated patients who initiated oral or injectable anti-diabetic medication within 3 months prior to Day 1
* Uncontrolled blood pressure, defined as a systolic value greater than (\>)180 millimeters of mercury (mmHg) and/or a diastolic value \>100 mmHg while a patient is at rest
* Currently pregnant or breastfeeding, or intend to become pregnant during the study
* Treatment with panretinal photocoagulation or macular laser within 3 months prior to Day 1 to the study eye
* Any intraocular or periocular corticosteroid treatment within 6 months prior to Day 1 to the study eye
* Prior administration of IVT faricimab in either eye
* Active intraocular or periocular infection or active intraocular inflammation in the study eye
* Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye
* Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than DME in the study eye
* Other protocol-specified inclusion/exclusion criteria may apply
Neoadjuvant Immunotherapy Plus Chemotherapy in Borrmann Type 4 and Large Type 3 Gastric Cancer

The aim of this study is to test the efficacy and safety of immunotherapy plus chemotherapy on people with a relatively rare type of gastric cancer. Participants will take the anti-PD-1 inhibitor (Tislelizumab) and platinum-based chemotherapy (oxaliplatin + capecitabine or oxaliplatin + S-1) in a 3-week cycle, followed by a radical operation after 6 cycles.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed gastric adenocarcinoma,cT1-2N+M0 or cT3-4NanyM0;
* Males or females, aged 18-70 years;
* Gastroscopy and abdominal computed tomography (CT) scan-confirmed typical scirrhous gastric cancer (borrmann type 4) or large type 3 (over 8 cm);
* No peritoneal metastasis confirmed by laparoscopic exploration and with cytological examination of peritoneal washing of the Douglas pouch;
* ECOG performance status 0 or 1;
* Sufficient organ function:

  * white blood cell count \> 4\*10\^9/L, neutrophil cell count \> 1.5\*10\^9/L, hemoglobin \> 90 g/L, platelet count \> 100\*10\^9 /L
  * Serum bilirubin ≤ 1.5×upper limit of normal (ULN), AST, ALT ≤ 2.5×ULN
  * Creatinine ≤ 1.5 ×ULN or serum clearance \> 60 ml/min
  * INR and aPTT ≤ 1.5 × ULN, only for subjects not receiving anticoagulant therapy;Subjects undergoing coagulation therapy should use a stable dose
* No prior anti-tumor therapy;
* Have signed informed consent before the beginning of treatment.

Exclusion Criteria:

* History of another malignancy within the last five years;
* Previous cytotoxic chemotherapy, radiotherapy or immunotherapy
* Unable to take drugs orally
* Allergic to to any drug of the study regimen;
* Women who are pregnant or breastfeeding or may be pregnant
Randomized Controlled Clinical Trial of Cinnamon to Lower Hemoglobin A1c

This study will randomize diabetics with hemoglobin A1c greater than 7.0 to receive either cinnamon plus usual care or usual care alone. Hemoglobin A1c will be measured at intake and after 90 days.

As the worldwide incidence of diabetes increases, the search for dietary adjuncts to treat this life-altering disease becomes far ranging. Cinnamon is purported to be a natural insulin sensitizer without any known adverse events. Both in vitro and in vivo animal studies have shown that cinnamon is an insulin sensitizer1. Several compounds within cinnamon have been identified as possible sources of this sensitization process.

To-date, three small randomized trials studying cinnamon in human diabetics have been published. Khan et al. reported that fasting serum glucose could be reduced by 18-29% after 40 days of supplementation with 1, 3, or 6 g of cinnamon (Cinnamomum cassia) in type 2 diabetics. 2 This study had several limitations that included failure to measure hemoglobin A1C, all patients were Pakistani, and no power analysis was documented. Vanschoonbeek, et al.3 report a small RCT of postmenopausal women with well-controlled type 2 diabetes which showed no change in HbA1C or fasting glucose. Once again no power analysis is reported. Mang et al. 4 conducted a RCT of type 2 diabetics treated with aqueous extract of cinnamon for 4 months. They report a 15% decrease in fasting glucose and no change in HbA1C over the duration of this trial. Subjects had HbA1C less than 7% and again no power analysis was included in this study.

This study will address whether cinnamon at the dose of 1g daily in addition to usual care lowers hemoglobin A1c compared to usual care. Power analysis indicates that 63 per group are needed and we will recruit 70 patients.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetics greater tahn 18 years of age

Exclusion Criteria:

* allergy to cinnamon pregnancy
Safety of Cream Containing Sericin and Turmeric in Healthy Volunteers

The object of this study was to evaluate safety of cream containing sericin and turmeric in healthy volunteers.

There are 106 healthy volunteers in this study. Upper left arm is divided into 2 parts (2x2 cm) which are A and B area. Upper right arm is divided into 2 parts (2x2 cm) which are C and D area. Four area (A, B, C, and D) are randomized to receive cream containing 2.5% sericin and 2%turmeric, cream containing 5%sericin and 2%turmeric, cream containing 10%sericin and 2%turmeric, and cream base (Control group). Samples are applied 2 times/day for 6 days (Induction phase). Then, the volunteers will stop applying samples for 7 to 10 days (Free period). After that, Samples are applied 2 times/day for 3 days (Challenge phase). Erythema, melanin, humidity, transepidermal water loss, skin adverse reaction, and satisfaction are evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 60 years
* No skin diseases
* No allergy to sericin and turmeric
* No immunocompromised disease or using steroid for 2 weeks before participated in this study
* Willing to participate in this study

Exclusion Criteria:

* Uncontrolled disease, cancer, and heart disease
* Cannot follow the protocol
* Pregnancy and lactation
* Participated in other studies
Impact of Therapeutic Drug Monitoring on Anti-Infective Agents Amongst Severely Burned Patients Requiring ICU Admission

Sepsis is the major cause of morbidity and mortality amongst burn patients. Burn shock and respiratory failure that used to be the major cause of mortality have progressively been replaced by sepsis and multiple organ failure. It is not rare that treatment failures occurs several weeks, or even months after injury as a consequence of sepsis usually caused by multi-drug resistant (MDR) microorganisms. Introduction of early surgery combined with topical and systemic antibiotherapy dramatically enhanced survival from sepsis after burn trauma, but further improvement is impaired by the rapid development of hard-to-treat MDR bacteria.

Correct prescription of anti-infective agents could be one way to curb the steadily increasing development of multidrug resistance. Administration of antibiotic to burn patient is complex: they frequently suffer from kidney dysfunction, they usually experience tremendous shifts of liquids between intra-vascular - inter-cellular and intra-cellular compartments, they often are hypo-albumin and protein-emic, and finally they present with a profoundly modified metabolism. All those aspects make this particular population of patients at high risk of both under or over prescription.

Monitoring of drug concentrations in the plasma of patients, so-called TDM for Therapeutic Drug Monitoring, has been introduced to clinical practice for several decades primarily to avoid toxicity of a small number of drugs with narrow therapeutic windows. However, with the increasing availability of detection techniques, the number of drugs that can be measured in the plasma of patients has grown tremendously over the last decade. As a consequence, it is currently possible to monitor drug concentrations not only to prevent toxicity, but also to improve efficacy. For instance, several studies demonstrated that TDM improved antibiotic prescription in different populations of hospitalized patients, including critically ill patients, with a direct impact on outcome.

Such studies amongst burn patients are however lacking, although this particular population is at high risk to suffer from mis-prescription. We thus hypothesize that systematic TDM could improve antibiotic prescription in this peculiar population. To this end, we propose to implement a 3-year prospective, randomized, mono-centric, clinical trial that will analyze the impact of systematic TDM on anti-infective agent prescription amongst burned patients.


Eligibility Criteria:
Inclusion Criteria:

* All adult burn patients (≥ 18 years) admitted to the University Hospital of Lausanne during the study period receiving systemic anti-infectives agents for which TDM is available will be included.

Exclusion Criteria:

* Patients not receiving systemic anti-infective agents therapy
* Patients with length of hospital stay \<72 hours
* Patients refusing to give their written consent (or for which the therapeutic representative refuses) or incapable of understanding and lack of legal representative
* Pregnant or breastfeeding women
* Children \<18 years
Closed-loop Control of Glucose Levels (Artificial Pancreas) for 5 Days in Adults With Type 1 Diabetes

Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings.

The main objective of this project is to compare the efficacy of single-hormone closed-loop strategy and sensor-augmented pump therapy to regulate glucose levels in outpatient settings for 5 consecutive days in adults with type 1 diabetes.

The investigators hypothesized that single-hormone closed-loop strategy will increase the time spent in the target range compared to sensor-augmented pump therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females ≥ 18 years of old.
2. Clinical diagnosis of type 1 diabetes for at least one year.
3. The subject will have been on insulin pump therapy for at least 3 months.
4. HbA1c ≤ 10%.
5. Live in the area of Montreal.

Exclusion Criteria:

1. Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
2. Recent (\< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
3. Warfarin chronic treatment if INR monitoring cannot be evaluated (can increase the risk of bleeding)
4. Pregnancy (ongoing or current attempt to become pregnant).
5. Severe hypoglycemic episode within two weeks of screening.
6. Current use of glucocorticoid medication (except low stable dose and inhaled steroids).
7. Known or suspected allergy to the trial products
8. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
9. Anticipating a significant change in exercise regimen between admissions (i.e. starting or stopping an organized sport).
Study of Autologous T-cells in Patients With Metastatic Pancreatic Cancer

This is a study in which pancreatic cancer patients receive a immunotherapy with CART-meso cells administered at 3 days after one dose of cyclophosphamide. CART-meso cells are patients' own T cells lentivirally transduced to express anti-mesothelin scFv fused to TCRζ and 4-1BB costimulatory domains.The lymphodepletion with cyclophosphamide may prolong the persistence of CART cells.

This study is being conducted to assess the safety and efficacy of immunotherapy with CART-meso cells in dose escalation design. The trial will begin in Cohort 1 and progress to Cohorts 2, depending upon dose limiting toxicity (DLT) assessment .

Subjects will be enrolled serially, but infusions will be staggered to allow assessment of DLTs for determination of cohort progression, expansion, or dose de-escalation.

Cohort 1 subjects will receive a single dose of 1-3x10\^7 /m\^2 lentiviral transduced CART-meso cells after conditioning chemotherapeutic regimen.

Cohort 2 subjects will receive a single dose of 1-3x10\^8 /m\^2 lentiviral transduced CART-meso cells cells after conditioning chemotherapeutic regimen.

Dose limiting toxicity is defined as any adverse reactions at level 3 or above that may be associated with CART-meso within 4 weeks after infusion.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Unresectable or metastatic pancreatic cancer
* Persistent cancer after at least one prior standard of care chemotherapy for advanced stage disease
* 18 - 70 years of age
* ECOG performance status of 0 or 1
* Life expectancy greater than 3 months
* Satisfactory organ and bone marrow function
* Meets blood coagulation parameters
* Male and Female subjects of reproductive potential agree to use approved contraceptive methods

Exclusion Criteria:

* Participation in a therapeutic investigational study within 4 weeks prior to the screening visit
* Anticipated need for systemic chemotherapy within 2 weeks before apheresis and infusion
* Active invasive cancer other than pancreatic cancer
* HIV, HCV, or HBV infections
* Active autoimmune disease requiring immunosuppressive therapy within 4 weeks prior to screening visit, with exception of thyroid replacement
* Ongoing or active infection
* Planned concurrent treatment with systemic high dose corticosteroids
* Patients requiring supplemental oxygen therapy
* Prior therapy with gene modified cells
* Previous experimental therapy with SS1 moiety, murine or chimeric antibodies
* History of allergy to murine proteins
* History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40)
* Clinically significant pericardial effusion, CHF, or cardiovascular condition that would preclude assessment of mesothelin induced pericarditis or that may worsen as a result of toxicities expected for this study
* Pregnant or breastfeeding women
Behavioral Treatment for Children With Conduct Problems and Callous-Unemotional Traits

The purpose of this study is to modify behavior therapy so that it is optimized for children with conduct problems and callous-unemotional traits by emphasizing reward components and de-emphasizing punishment components.

Several studies have demonstrated that standard behavioral treatments do not appear to be sufficient for children with conduct problems (CP) and callous-unemotional (CU) traits. Other research suggests that children with CPCU are less responsive to punishments as evaluated using controlled laboratory tasks. Based on these two sets of findings, it was hypothesized that behavioral treatment modified to emphasize reward and de-emphasize punishments would be advantageous when used to treat children with CPCU. This hypothesis was tested in a treatment development study that had three phases. During phase 1, which occurred in 2010, the intervention was planned and treatment procedures and manuals were developed. During phase 2, which occurred in 2011, a pilot study was conducted in which the intervention was tested in an iterative manner in a group of 12 children with conduct problems and callous-unemotional traits. In phase 3, a larger trial was conducted using a cross over design, with one-half of participants getting standard behavioral treatment for four weeks followed by modified behavioral treatment for four weeks and remaining participants receiving treatments in the reverse order.Treatments were evaluated using parent ratings, counselor ratings, and frequency counts of behavior during treatments.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of oppositional defiant disorder or conduct disorder
* Ages 7 to 12 years old
* t-score of 65 or above on CU scale of Antisocial Process Screening Device as rated by parents or teacher
* at least parent/caregiver fluent in English
* able to participate in vigorous outdoor activities
* parent/caregiver agreement to keep psychoactive medication treatment constant throughout the study

Exclusion Criteria:

* Full scale intelligence quotient (IQ) of less than 75
* medical conditions that contra-indicate participation in treatment
* current or past clinical diagnosis of pervasive developmental disorder, schizophrenia or other psychotic disorders, sexual disorder, organic mental disorder, or eating disorder
* lack of functional impairment
* current or past seizures or other neurological disorders
Aneurysm Diameter and Surgical Outcome

Aneurysm diameter is an important risk for rupture and related death in affected patients.

This study will evaluate whether aneurysms size may even influence post procedural outcomes both in open surgical repair and in end-vascular aneurysm repair.

We will retrospectively review clinical data of operated patients with abdominal aortic aneurysm. We will consider both open surgical repair and endovascular aneurysm repair procedures in order to assess the influence of aneurysm size at the time of intervention.

Since the publication by Szilagyi et al, size of aneurysms has been recognized as the predominant risk factor for rupture. In fact, a low risk is associated with small aneurysms, an intermediate risk with medium-sized aneurysms, and dramatically an increased risk with large aneurysms. Current guidelines suggest that the threshold diameter for aneurysm surgery being 5.5 cm for male patients and 5.0 cm for female patients, as measured on the largest section of the aneurysm.

The correlation aneurysm diameter may also have an impact on early and late postoperative outcomes both for open surgery and endovascular surgery. The study by Peppelenbosch N et al. showed that size differences were strongly associated with adverse outcomes during follow-up of patients that underwent endovascular aneurysm repair.

The aim of this is to assess the influence of aneurysm size on the early and late outcomes of open surgical repair (OSR) and endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAA).

Preoperative patient characteristics, comorbid conditions, aneurysm anatomy and diameters will be retrospectively reviewed in order to correlate with the results of the procedures (OSR and EVAR) and with adverse outcome that may have been occurred during follow up.

Eligibility Criteria:
Inclusion Criteria:

* patients with abdominal aortic aneurysm who underwent open surgery or endovascular procedures with complete anatomic data of aneurysms and clinical data with a minimus of 5 years of follow up.

Exclusion Criteria:

* none
A Trial to Evaluate a Device for the Treatment of OSA and Snoring

To evaluate the safety and efficacy of the Tongue Advancement Retainer Device in treating subjects with Obstructive Sleep Apnea (OSA) and snoring.

The Tongue Advancement Retainer Device is a device that was developed to treat subjects with OSA and snoring. The purpose of this study is to evaluate initial safety and effectiveness of this device in treating one or both conditions.

Eligibility Criteria:
Inclusion Criteria:

* • Aged 18-65

  * AHI greater than or equal to 10 but less than or equal to 60 (\<10 AHI \<60/hr)
  * Complete set of lower anterior incisors with no evidence of periodontal disease or mobility and the ability to floss between teeth

Additionally subjects will in the screening phase must:

* Tolerate the device when being fitted
* Used the device for \>4 hours on at least two consecutive nights during the screening period.
* Be able to reliably demonstrate proper installation of the device after fitting.
* Be willing to trial the device for a 4 week period

Exclusion Criteria:

* • Central sleep apnea events \>10% of the total events

  * Evidence of Cheyne stokes breathing
  * Currently on treatment for OSA or OSA treatment discontinued less than 3 months prior.
  * Currently on regular treatment with prescription hypnosedatives or prescription stimulants
  * Very severe OSA, defined as AHI\>60/hour and/or minimum oxygen saturation \<75%
  * Need for immediate initiation of treatment as assessed by physician (e.g. Excessive sleepiness posing driving risk)
  * Previous surgery to treat OSA (other than nasal surgery)
  * Evidence of periodontal disease or tooth mobility
  * Severe nasal obstruction or enlarged tonsils based on clinical assessment
  * Unstable cardiovascular disease (untreated hypertension acceptable).
  * Inability to tolerate oral device due to oral condition or claustrophobia as determined by the study investigator
  * Pregnant/Breast Feeding
  * Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as co-existent other sleep disorder, psychiatric disease, history of non compliance to medical regimens, or unwillingness to comply with study requirements.