cyrilzakka/clinical-trials huggingface dataset:
Study of Personalized Tumour Vaccines and a PD-L1 Blocker in Patients With Surgically Resected Pancreatic Adenocarcino

This is a phase 1, open-label study to evaluate the safety and tolerability of neoantigen personalized mRNA tumour vaccine combined with Adebrelimab (a PD-L1 humanized monoclonal antibody) in patients with surgically resected pancreatic adenocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily signed the informed consent form and complied with protocols requirements.
2. Patients with radiographically resectable primary pancreatic tumors with histopathology or cytology confirmed resected ductal pancreatic adenocarcinoma (PDAC) with macroscopic complete resection (R0 and R1).
3. Pancreatic cancer surgical staging per AJCC 8th edition staging: T 1-3, N0-2, M0.
4. Tumour specimen availability.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
6. Life expectancy ≥ 6 months.
7. Surgical complications have recovered, or complications lower than Clavien-Dindo complication grade 3.
8. Adequate marrow and organ function.
9. Patients with fertility are willing to use an adequate method of contraception.

Exclusion Criteria:

1. Prior anti-PDAC therapy (e.g., chemotherapy, radiotherapy, targeted therapy, immunotherapy and therapeutic tumor vaccines) prior to initiation of study treatment.
2. Unsuitable for immunotherapy assessed by the investigator.
3. Plan to receive a live-attenuated vaccine within 28 days prior to initiation of study treatment or during the study treatment or within 90 days after the end of study treatment.
4. Have any active autoimmune disease, or have a history of autoimmune disease and have received systemic therapy in the past 2 years.
5. Active tuberculosis or a history of active tuberculosis infection within 28 days prior to initiation of study treatment.
6. Known or highly suspected history of interstitial pneumonia.
7. Allergic to research drug ingredients, or have a history of severe allergic reactions to other vaccines.
8. Prior malignancy within 5 years prior to study entry.
9. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
10. Known splenectomy history.
11. Concurrent severe infection within 28 days prior to initiation of study treatment.
12. Congenital or acquired immune deficiency.
13. Active hepatitis B (HBV-DNA≥1000IU/ml), hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the lower limit of assay).
14. Uncontrolled or severe cardiovascular disease.
15. Other situations that are not suitable for inclusion in this study judged by investigator.
Restoring Black Triangle With Bioclear Matrix Versus Celluloid Conventional Matrix Method

Assessment of bioclear matrix and injection molding technique against conventional celluloid matrix technique in management of black triangle.

Patients with black triangle defect in anterior teeth (Cl I and Cl II according to Nordland and Tarnow classification) managed by Bioclear matrix with injection molding technique and conventional celluloid matrix technique.

Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for the trial must comply with all of the following:

  * Cl I and cl II according to Nordland and Tarnow classification
  * Good oral hygiene
  * Good general health
  * Cooperative patient
  * Subjects who signed the informed consent
  * Patient compliance

Exclusion Criteria:

* Cl III according to Nordland and Tarnow classification
* Uncontrolled parafunction.
* Insufficient oral hygiene
* Periodontal and gingival diseases
* Pregnant and nursing
* Disabilities
* Systemic disease or severe medical complications
* Lack of compliance
IOP Lowering Efficacy of Travoprost/Brinzolamide Fixed Combination Ophthalmic Suspension in Patients With Open-Angle Glaucoma or Ocular Hypertension

The purpose of this study is to compare the safety and IOP-lowering efficacy of a fixed combination of Travoprost/Brinzolamide Ophthalmuc Suspension dosed BID and QD, to TRAVATAN dosed QD and a Vehicle dosed BID in patients with open-angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older of either sex and any race with diagnosed open-angle glaucoma or confirmed ocular hypertension

Exclusion Criteria:

* Age (Under 18)
Language and Music, Speech and the Human Beatbox: Theoretical Issues for Research in General and Applied Linguistics

Beatboxing is a form of vocal percussion primarily involving the art of mimicking drum machines, using one's mouth, lips, tongue, and voice. It may also involve vocal imitation of turntablism, and other musical instruments. To produces the different sounds, the Beatboxers use their vocal apparatus in a much wider and more complex way than its use in speech. This allows them to acquire a panel of rich and varied sounds. The Human Beatbox (HBB) is a very recent subject of study in phonetics. This study offers an exploratory study of pharyngolaryngeal articulatory behaviors using nasofibroscopy and electroglottography and an aerodynamic study in order to better understand the articulatory capacities and limits of the vocal tract.

HBB is characterized by two very interesting aspects (1) the complexity of the oro-pharyngo-laryngeal joints and the articulatory precision of the beatboxers and (2) the respiratory management which allows the artists to beatbox continuously without interrupting their performance. These two points, very characteristic of this technique, allow them to best imitate diverse and varied musical tones.

The Human Beatbox is still little studied and the literature on this subject is quite limited. Percussive sounds (for example imitations of bass drums, hi-hat or snare) seem to be characterized by articulatory strategies, melodic sounds (for example wind instruments, strings) seem to be based on both articulatory and phonatory strategies, and finally, electronic sounds seem to mainly use complex phonatory strategies.

Our objectives are to better understand the articulatory capacities and limits of the vocal tract at different levels (articulation capacities, sound production mechanisms, muscular and acoustic temporal relationships, strategies of efficiency...).

It is possible to find clinical applications of the Human Beatbox in the context of congenital speech disorders (for example dyspraxia) or acquired (for example oro-pharyngo-laryngeal surgery of the partial glossectomy type).

Eligibility Criteria:
Inclusion Criteria:

* Healthy subject aged 18 or over
* Beatboxer subject (singer specializing in Beatboxing)
* Absence of language impairment
* Absence of vocal pathology
* Have signed a consent form
* Be affiliated with a Health Insurance plan.

Exclusion Criteria:

* Pregnant, parturient or lactating women
* Persons deprived of their liberty: minors or adults subject to legal protection measures or out of state to express their consent
* Subjects under guardianship or under curators
An Evaluation of a Culturally- and Linguistically-Appropriate Online Diet Program for U.S Hispanics

The purpose of this study is to conduct a randomized trial to rigorously test the efficacy of the MiDieta eHealth portal for weight loss among overweight, though otherwise healthy, members of the Hispanic community, many of whom may be members of collaborating managed care organizations.

Obesity is a major and growing problem among U.S. Hispanics with serious implications for diabetes and other chronic disease risks. Current trends among youth suggest that disparities in obesity between minorities and non-Hispanic whites will amplify. Reducing such health disparities is a priority for federal, state and local governmental bodies and communities. Attaining these objectives will require interventions that are culturally- and linguistically appropriate. U.S. healthcare providers, however, have few culturally-appropriate tools and inadequate numbers of bilingual, trained healthcare professionals to address these challenges.

A culturally-appropriate weight-management portal, supported by bilingual Latina dietitians available for remote email counseling, offers an attractive mechanism for efficiently serving the underserved. MiDieta/MyDiet is the leading online diet, fitness and weight management portal for U.S. Hispanic/Latinos. MiDieta is bilingual (Spanish/English), based on Latino foods \& habits and already available through dozens of media, hospital, and health plan websites. Thousands of Hispanics access MiDieta each week. Tommy Thompson recently selected MiDieta as one of the "20 most innovative health promotion and disease prevention applications" in the U.S.

Eligibility Criteria:
Inclusion Criteria:

* Women and men of Hispanic/Latino origin born in Mexico, Central or South America, the Caribbean, Spain or the United States
* Between 18 and 75 years of age
* BMI \>/= 24.85
* Otherwise "healthy" individuals (lack of major medical/psychiatric/ or chronic problems/disease - with the exception of Type 2 diabetes and controlled hypertension)
* Not participating in other weight loss treatment programs and not planning on it for at least 12-16 more months
* Internet access at least once per week
* The participant has the ability to engage in at least light activity (walking, etc)

Exclusion Criteria:

* The participant has a continuous history of major medical or psychiatric problems (requiring continuous medication and/or close physician supervision)
* Diagnosis with Type 1 diabetes
* The participant is pregnant or planning a pregnancy within the next 16 months
* The participant is unable to participate in any exercise regimen
* The participant is currently participating in MiDieta
* The participant is currently participating in other weight loss programs or plans to in the next 12-16 months
A Study of AK104/Placebo Combined With Chemoradiotherapy For The Treatment of Locally Advanced Cervical Cancer

This study is to evaluate the efficacy and safety of AK104 plus concurrent chemoradiotherapy compared to placebo plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer


Eligibility Criteria:
Inclusion Criteria:

1. signs the written informed consent form
2. ECOG 0-1
3. Life expectancy ≥ 3 months.
4. The histological types include squamous cell carcinoma,adenocarcinoma, or adenosquamous cell carcinoma;
5. Locally advanced cervical cancer (LACC): The International Federation of Gynecology and Obstetrics (FIGO) 2018 Stage 3A-4A
6. At least one measurable tumor lesion per RECIST v1.1
7. Adequate organ function as assessed in the laboratory tests

Exclusion Criteria:

1. Subjects with other histopathological types of cervical cancer, such as small cell carcinoma, sarcoma, etc.
2. FIGO 2018 IVB
3. Subjects who had previously undergone total hysterectomy
4. Subjects who cannot receive brachytherapy
5. Subjects with other active malignancies within 2 years prior to randomization
6. Clinically significant hydronephrosis that cannot be relieved by nephrostomy or ureteral stenting as judged by the Investigator
7. Any prior treatments targeting the mechanism of tumor immunity, such as immune checkpoint inhibitors (e.g., anti-PD-1 antibody, anti-PDL1 antibody, anti-CTLA-4 antibody, etc.), or therapy against immune costimulatory factors (e.g., antibodies directed against ICOS, CD40,CD137, GITR, OX40 targets, etc).
8. Subjects who require systemic treatment with glucocorticoid (\>10 mg/day of prednisone or equivalent glucocorticoid) or other immunosuppressive agents within 14 days prior to randomization;
9. Major surgical treatment, open biopsy or significant trauma within 4 weeks prior to randomization; or elective major surgical treatment required during the study
10. Use of live vaccines within 4 weeks prior to randomization
11. Active or potentially recurrent autoimmune disease
12. Known primary or secondary immunodeficiencies, including testing positive for human immunodeficiency virus (HIV) antibodies
13. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
14. Known history of interstitial lung disease or non-infectious pneumonitis
15. Pregnant or lactating women.
16. Any condition that, in the opinion of the Investigator, may result in a risk when receiving the study drug.
Exogenous Ketone Supplementation in Females with Polycystic Ovary Syndrome

Polycystic ovary syndrome (PCOS) affects 1 in 5 females of reproductive age. Commonly characterized as a disorder of infertility, PCOS is often accompanied by 3 potent cardiovascular disease (CVD) risk factors: insulin resistance, endothelial dysfunction, and elevated blood pressure. Accordingly, PCOS is associated with the development of CVD, the second leading cause of death in females in Canada. However, effective treatments to improve cardiovascular health in PCOS are lacking.

Exogenous ketone monoester (KME) ingestion has been shown to improves outcomes associated with insulin resistance, endothelial function, and blood pressure regulation in healthy individuals and individuals predisposed to CVD. Therefore, oral ketone supplements offer a practical and effective strategy for improving cardiovascular health; however, this treatment has yet to be evaluated in PCOS.

Therefore, the overall goal of this project is to employ KME ingestion to improve markers of cardiovascular health in females with PCOS.

On two different days, participants will consume either a beverage containing a ketone supplement or a beverage containing a placebo supplement. The objectives are to compare responses between KME and placebo ingestion, and examine all outcomes related to cardiovascular health in females with PCOS in comparison with female controls of similar age and body mass index. The effects of KME ingestion will be quantified on: 1) glycemic control during an oral glucose tolerance test; 2) endothelial function using the flow-mediated dilation test; 3) blood pressure and acute blood pressure regulation; and 4) hemodynamic responses to acute exercise.


Eligibility Criteria:
Inclusion Criteria:

* All female participants will report female sex assigned at birth
* All participants will be aged 18 to 40
* PCOS diagnosis

Exclusion Criteria:

* Current smokers or a prolonged history of smoking
* Presence or history of overt cardiometabolic disease (e.g., stage 2 hypertension, diabetes, heart disease), neurologic disease, or endocrinopathy (with the exception of PCOS)
* Current pregnancy or currently breastfeeding
* Current use of medications which may affect our outcomes of interest (e.g., anti-hypertensives, anti-androgens, metformin)
Study Of Eltrombopag in Healthy Subjects and Volunteers With Mild, Moderate or Severe Hepatic Impairment

The main purpose of this study is to compare how one 50mg tablet of SB-497115 is broken down in the body by healthy subjects versus subjects with mild, moderate or severe liver problems. The study is also being done to 1) check on how well the study drug is tolerated by healthy subjects versus those with liver problems and 2) to check if liver impairment affects how the study drug binds to protein in the blood.


Eligibility Criteria:
Inclusion criteria:

* Healthy or have liver impairment
* Females(the following requirement applies only if able to have children): agree to doctor approved birth control methods, or partner has had a vasectomy.
* Body mass index (BMI-within acceptable range)
* Negative drug, alcohol, and HIV tests

Exclusion criteria:

* Taking a medication or therapy not approved by the study doctor
* Rapidly changing liver function
* Kidneys not working well
* Drug or alcohol abuse within past 6 months
* Used an investigational drug in the past 30 days
* Females that are pregnant or nursing
* Have active hepatitis B or C
* History of blood disorders
* History of various heart conditions (as noted by study doctor)
* Blood clotting problems or blood abnormalities
Imfinzi/Imjudo NSCLC Japan PMS_Japan Post-Marketing Surveillance (PMS) Study - CEI/SCEI

To collect information of safety in patients with unresectable advanced or recurrent non-small cell lung cancer who receive combination therapy of IMJUDO, IMFINZI and other platinum-based anti-cancer agents under actual use in the postmarketing setting.

This investigation will be conducted to collect information of safety in patients with unresectable advanced or recurrent non-small cell lung cancer (NSCLC) who receive combination therapy of IMJUDO Intravenous Infusion 25mg, IMFINZI Intravenous Infusion 120mg, 500mg and other platinum-based anti-cancer agents under actual use in the postmarketing setting.

The investigation will be conducted as one of the additional pharmacovigilance activities in the Japan Risk Management Plan of IMJUDO and IMFINZI in compliance with the Ministerial Ordinance on Good Postmarketing Study Practice (GPSP Ordinance) and for the purpose of application for reexamination under Article 14-4 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.

Among the safety specifications defined in the Japan Risk Management Plan of IMJUDO and IMFINZI, the following items are set as the safety specifications for this study.

Interstitial lung disease, Colitis/Severe diarrhoea/Gastrointestinal perforation, Hepatic function disorder/Hepatitis/Cholangitis sclerosing, Endocrine disorders (Dysfunction thyroid, Adrenal dysfunction, Pituitary dysfunction), Type 1 diabetes mellitus, Renal disorder (interstitial nephritis, etc.), Myositis, Myocarditis, Myasthenia gravis, Immune thrombocytopenic purpura, Encephalitis, Severe skin disorder, Nerve disorder (including guillain-barre syndrome), Infusion reaction, Pancreatitis, Rhabdomyolysis, Meningitis, Febrile neutropenia during combination treatment with chemotherapy, Embryo-fetal toxicity, Use in patients with a history of organ transplant (including haematopoietic stem cell transplant)

Eligibility Criteria:
Inclusion Criteria:

* All patients who receive IMJUDO, IMFINZI and other platinum-based anti-cancer agents for their unresectable advanced or recurrent NSCLC

Exclusion Criteria:

-
LMA Placement Techniques and Airway in Children and Oropharyngeal Leak Pressure

Our study aimed to compare the manual placement, direct laryngoscopy and video laryngoscopy assisted placement techniques of LMA Proseal, a new generation laryngeal mask (LMA), and to find an effective placement technique that does not allow airway leakage in one go.

LMA is an airway device frequently used in pediatric anesthesia. It is preferred for short interventions because it is less invasive compared to intubation. However, problems such as not being fully seated, slipping, and leakage can be encountered during placement. Multiple attempts after unsuccessful placement may cause undesirable results such as edema and sore throat. The aim in this study is to reveal the most accurate placement technique and to transfer this method to clinical applications.

Our research is a prospective, randomized controlled method study.

Patients will be divided into 3 groups.

Group 1:(Standard technique)

Group 2:(Placement with direct laryngoscopy)

Group 3:(Placement with the aid of video laryngoscopy)

After LMA Proseal placement, airway sealing pressures will be measured with appropriate technique. Airway tightness pressure measurement will be made with the technique accepted in the literature through the sensors in the anesthesia machine.

Eligibility Criteria:
Inclusion Criteria:

* 1-10 years old
* Between 5-40 kg
* ASA (American Society of Anesthesiologists) physical score I/II
* Cases undergoing elective surgery lasting less than 90 minutes

Exclusion Criteria:

* Patients who are expected to have a difficult airway
* Those with potential regurgitation risk (severe GER, presence of hiatal hernia)
* Those who will undergo head and neck surgery, laparoscopic surgery
* Those who will undergo surgery in the prone position
* Emergency surgical interventions
* Those who need muscle relaxants
* Presence of intraoral abscess, pharyngeal pathology
* Those who have had an upper or lower respiratory tract infection in the last 4 weeks
* History of allergy to the drugs to be used
* Failure of patients and their relatives to give consent
A Trial of N-Acetylcysteine (an Over-the-Counter Medicine) in Adolescents Who Smoke Marijuana

This study is investigating how N-Acetylcysteine (NAC), an over-the-counter medication, will reduce marijuana use when combined with Contingency Management, a behavioral treatment. It is hypothesized that marijuana dependent adolescents who are treated with NAC will use less marijuana during treatment when compared to adolescents who receive a placebo.

This protocol involves investigation of N-Acetylcysteine (NAC) as a pharmacological treatment for cannabis dependence in adolescents. While recent advances have been made in psychosocial treatments for cannabis dependent adolescents, minimal work has been done to investigate the potential adjunctive role for pharmacotherapy in treatment. NAC is an inexpensive, over-the-counter agent with a favorable tolerability profile in adults and children, in common use since FDA approval in 1963. Preclinical and preliminary clinical research in adults suggests a role for NAC in addiction treatment via glutamate modulation.

Eligibility Criteria:
Inclusion Criteria:

* Age 13-21 years
* Regular Marijuana smoker meeting DSM-IV criteria for cannabis dependence and seeking marijuana cessation treatment

Exclusion Criteria:

* Allergy or intolerance to NAC
* Pregnancy or lactation
* Use of carbamazepine or nitroglycerine (or any other drug deemed to be hazardous if taken with NAC) within 14 days of study participation
* Current enrollment in treatment for cannabis dependence
* Current substance dependence, other than cannabis or nicotine
* Significant medical or psychiatric illness that may place the participant at increased risk in the judgement of the study physician
Intra-arterial Tenecteplase During First Thrombectomy Attempt for Acute Stroke (BRETIS-TNK II)

A recent pilot study suggests intra-arterial tenecteplase (TNK) during the first pass of endovascular treatment (EVT) seems safe, may increase first-pass reperfusion and good outcome in acute ischemic stroke (AIS) patients with large vessel occlusion (LVO).

The study aimed to determine the efficacy and safety of intra-arterial TNK administration during EVT in AIS-LVO patients.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years;
* Stroke patient with large vessel occlusion (internal carotid artery, M1 or M2 of middle cerebral artery, basilar artery, or intracranial segment of vertebral artery) who meets criteria for endovascular treatment within 24 hours of stroke onset;
* The modified Rankin Scale (mRS) score before onset ≤ 2;
* ASPECTS 6 or greater on CT
* Signed informed consent.

Exclusion Criteria:

* hemorrhagic stroke;
* Tandem occlusion;
* Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia (\<100000/mm3);
* Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), elevated serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
* Severe uncontrolled hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);
* Patients with contraindication or allergic to any ingredient of drugs in our study;
* Pregnancy, or plan to get pregnant or during active lactation;
* Suspected septic embolus or infective endocarditis
* The estimated life expectancy is less than 6 months due to other serious diseases;
* Other conditions unsuitable for this clinical study as assessed by researcher.