cyrilzakka/clinical-trials huggingface dataset:
SHP2 Inhibitor BBP-398 in Combination With Sotorasib in Patients With Advanced Solid Tumors and a KRAS-G12C Mutation

This is a Phase 1 study of BBP-398, a SHP2 inhibitor, in combination with sotorasib, a KRAS-G12C inhibitor (KRAS-G12Ci), in patients with a KRAS-G12C mutation.

The study involves 2 parts: Phase 1a Dose Escalation and Phase 1b Dose Expansion/Optimization.

The primary objectives for Phase 1a Dose Escalation are to evaluate safety and tolerability, and recommend a phase 1b dose (RP1bD) of the combination.

The primary objectives for Phase 1b Dose Expansion/Optimization are to evaluate safety and tolerability, and the antitumor activity (defined by the ORR assessed by the investigator according to RECIST v1.1) of BBP-398 when used in combination with sotorasib across two dose regimens in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a KRAS-G12C mutation and who are KRAS-G12Ci naïve, and recommend a phase 2 dose (RP2D) of the combination.

Eligibility Criteria:
Key Inclusion Criteria:

* Patients must have histologically documented, locally advanced and unresectable, or metastatic solid tumor with documentation of a KRAS-G12C mutation within 2 years prior to screening.
* Patients must have measurable disease by RECIST v1.1.
* Patients must have a minimum life expectancy of \>12 weeks after start of study treatment.
* Patients must have progression or disease recurrence on or after all available standard of care therapies.
* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
* Patients must have adequate organ function.

Key Exclusion Criteria:

* Patients that have participated in an interventional clinical study within the last 4 weeks.
* Patients that have received radiotherapy or proton therapy with a limited field of radiation for palliation within 1 week of the start of study treatment, OR radiation to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the start of study treatment.
* Patients with untreated and/or active CNS metastases.
* Patients that have a history of allogenic bone marrow transplant.
Antimicrobial Stewardship in Community Pharmacy

Acute otitis media (AOM) is the most common indication for antibiotics for Canadian paediatric patients. As the gatekeepers of safe and effective prescription pharmacotherapy, community pharmacists are well positioned to influence and optimize antibiotic use. The purpose of this project is to develop, implement, and evaluate an antimicrobial stewardship program in the community pharmacy setting that aims to optimize antibiotic use for AOM. This nonrandomized pre-post study includes children aged 6 months to 12 years presenting with an antibiotic prescription for AOM at two community pharmacies in Toronto, Ontario. Participants are excluded if they exhibit signs/symptoms of mastoiditis, have an additional indication for systemic antibiotics, or parents/guardians cannot consent in English. The multifaceted AMS intervention includes pharmacist education, a clinical decision support tool, a parent/guardian questionnaire, and individualized monthly audit and feedback with each pharmacist. Prescriptions are reviewed and adapted by the pharmacist to optimize congruence with 2016 Canadian Paediatric Society AOM guidelines. The primary outcome is the percentage change in guideline congruence attributable to pharmacist intervention. This study will provide insight into the opportunities and barriers of developing large-scale antimicrobial stewardship programs for community pharmacies.


Eligibility Criteria:
Inclusion Criteria:

* Prescribed systemic oral antibiotic therapy
* Antibiotics are indicated for the treatment of acute otitis media (AOM) as reported verbally or in writing by parent/guardian or prescriber

Exclusion Criteria:

* signs/symptoms of mastoiditis
* a diagnosis in addition to AOM for which systemic antibiotics are indicated
* parents/guardians cannot consent to the study in English
Impact of Motor and Oral Motor Function on Quality of Life in Children With SMA

The aim of this study is to investigate the impact of motor and oral motor functions on the quality of life in children aged 2-4 years diagnosed with Spinal Muscular Atrophy (SMA) Type I. In the study, the Neuro-Sensory-Motor Developmental Assessment (NSMDA) was used to evaluate motor functions, the Functional Oral Intake Scale (FOIS) to assess oral motor function, the Behavioral Pediatric Feeding Assessment Scale (BPFAS) to evaluate children's attitudes towards feeding, and the Pediatric Quality of Life Inventory (PedsQL) Neuromuscular Module to assess quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Spinal Muscular Atrophy Type I
* Being between the ages of 2-4
* Families volunteering to participate in the study

Exclusion Criteria:

* Accompanied by another chronic disease other than SMA
* The mother or father has a cognitive problem that prevents them from expressing themselves
* The mother or father is illiterate
Aromatherapy as Treatment for n/v of Pregnancy

A double-blinded randomized controlled trial comparing essential oil aromatherapy versus placebo for treatment of first trimester nausea and vomiting of pregnancy.

This is a double-blinded randomized controlled trial investigating the utility of essential oils for aromatherapy, compared to placebo, for treatment of nausea and vomiting in the first trimester of pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Pregnancy at \<14 weeks gestation
* English-speaking
* Baseline PUQE score \>=6

Exclusion Criteria:

* Non-compliant with prenatal care or study procedures
* Hyperemesis gravidarum
* Allergies to perfumes, essential oils or cosmetics
* Abnormal sense of smell
* Known acute or chronic GI disease
* Asthma
* Use of prescription anti-emetics
Effect of a High-fat Meal on the Pharmacokinetics of Hetrombopag and Mass Balance Study in Healthy Subjects

This open-label, randomized, two-period, two-treatment (single doses of 7.5 mg hetrombopag fasted or fed), crossover study was conducted to evaluate the effect of a high-fat meal on the pharmacokinetics of hetrombopag and mass balance study in 12 healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy.
* Weight≥50 kg，19≤BMI≤28 kg/m2.
* Platelet count is within normal range

Exclusion Criteria:

* History of clinically significant illness.
* History of alcohol or drug abuse.
Monitoring Pregnant Women for Antimalarial Drug Resistance

Annually, malaria affects an estimated 229 million people, causing 409,000 deaths (WHO 2019) mostly in Africa. Despite a substantial decline in malaria-related maternal and child deaths in recent years, progress in controlling malaria has been slower than anticipated and uneven across countries. COVID-19-related disruption of malaria control activities will likely further slow the pace and lead to an even greater burden in the near future.

One of the greatest challenges delaying progress in malaria elimination is antimalarial drug resistance. Recent reports of the emergence of artemisinin-resistant parasites in parts of Africa are the cause of even greater concern, since the loss of frontline treatment efficacy could bring about a dramatic reversal of progress.

Large-scale genetic surveillance of Plasmodium is an effective tool for rapid detection of changes in drug efficacy, enabling countries to switch to effective preventive and curative treatments when necessary. The implementation of genetic surveillance has proven very successful in small, low malaria burden countries. However, in large, high malaria burden countries such implementation is operationally and economically more complex.

Screening pregnant women attending Antenatal Care (ANC) services can be a practical and economical strategy for estimating malariometric parameters, with fewer limitations and challenges than conventional survey methodologies in children. The present study aims to demonstrate that this is also true for the genetic surveillance of antimalarial drug resistance.


Eligibility Criteria:
Inclusion Criteria:

* Pregnancy OR for children age \<14 years old and in primary school

Exclusion Criteria:

* Refusal to participate (i.e., consent is not given by the participant for women or by the parents in the case of children)
Study of VX-661 Alone and in Combination With Ivacaftor in Subjects Homozygous or Heterozygous to the F508del-Cystic Fibrosis Transmembrane Conductance Regulator(CFTR) Mutation

The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) effects of VX-661 alone and when coadministered with ivacaftor in participants with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del-CFTR mutation.

This is a Phase 2, randomized, multicenter, double-blinded, placebo-controlled, study of VX-661 monotherapy, and VX-661/ivacaftor co-therapy in participants with CF who are homozygous or heterozygous for the F508del CFTR mutation.

This study is separated into seven groups: Group 1-7, respectively. Approximately 180 participants were randomized in a ratio of 4:1; active drug to matching placebo in each group.

Eligibility Criteria:
Inclusion Criteria:

* Male or female with confirmed diagnosis of CF
* Must have the F508del-CFTR gene mutation in both alleles (Groups 1, 2, 3, 4, 5, 6). Group 7 participants must have the F508del-CFTR mutation on 1 allele, and gating mutation G551D on the second allele and have been on their physician prescribed 150 mg KalydecoTM q12h (commercially available ivacaftor) for at least 28 days at the Screening Visit.
* Forced expiratory volume in 1 second(FEV1) 40% to 90% (inclusive) of predicted normal for age, gender, and height (Knudson standards) at screening
* Weight \>40 kg and BMI \>18.5
* Participants of child-bearing potential and who are sexually active must meet the contraception requirements.

Exclusion Criteria:

* History of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant.
* An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 4 weeks before Study Day 1.
* History of solid organ or hematological transplantation
* Participation in a clinical study involving administration of either an investigational or a marketed drug within 30 days or 5 terminal half-lives (whichever is longer) before screening
* History of alcohol, medication, or illicit drug abuse within 1 year prior to screening
* Pregnant, breast-feeding, or not willing to follow contraception requirements
Dose-Ranging Efficacy and Safety Study of Topical Rapamycin Cream for Facial Angiofibroma Associated With Tuberous Sclerosis Complex

The study aims to compare the safety and efficacy of two different strengths of Rapamycin cream, topical and placebo over 26 weeks in the treatment of facial angiofibroma (FA) associated with Tuberous Sclerosis Complex (TSC).

Topical rapamycin has previously been used to treat FA associated with TSC, reducing erythema, papule size, while flattening lesions and improving skin texture. Topical rapamycin has been reported to be well tolerated.

The efficacy and safety of a topical rapamycin cream at two strengths (0.5% and 1.0%) will be assessed during a 26 week double-blind treatment phase with assessments made at clinical visits at baseline, 2, 8, 14, 20 and 26 weeks, and at follow-up (4 weeks after the last dose of study drug).

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients aged ≥ 6 years and ≤ 65 years on the day informed consent is obtained
2. Patients diagnosed with TSC based on the clinical diagnostic criteria of International Tuberous Sclerosis Complex Consensus Conference 2012 and presenting visible facial angiofibroma
3. An FA severity score of 2 or 3 on the IGA scale
4. Patients or their legal representatives capable of understanding the explanation of the clinical trial and who give written informed consent for participation
5. Patients or their legal representatives able to maintain patient diaries following the instructions of the investigator or sub-investigator

Exclusion Criteria:

1. Patients who cannot carry out the treatment plan or follow-up assessment
2. Patients with serious skin lesions such as erosions or ulcers
3. Patients with known hypersensitivity to any component of the study product
4. Patients who have received rapamycin/sirolimus, everolimus, or temsirolimus within 3 months of enrolment
5. Patients who received laser therapy or surgical therapy within 6 months prior to trial enrolment
6. Patients who participated in any other clinical trial within 3 months prior to the day of enrolment
7. Patients judged unsuitable for this clinical trial by the investigator or sub-investigator
8. Pregnant or lactating females
9. Sexually active females of childbearing potential not using adequate contraception and sexually active males not using adequate contraception
10. Patients with immune dysfunction or receiving any form of immunosuppression
11. Patients with severe FA, with a score of 4 on the IGA scale
12. Patients with an FA severity score of less than 2 on the IGA scale
Effects of Riboflavin in Mitigating Muscle Soreness in Ultra-marathon Athletes

The aim of this project is to investigate the effects of riboflavin, also known as vitamin B2, on preventing delayed onset muscle soreness (DOMS) in ultramarathon athletes through a randomized placebo-controlled study.

The riboflavin 100 mg capsules will be self-dosed by the participant, one capsule prior to the long stage of the race followed by a second dose at the end of the long stage. Historically, long-stage finish times have ranged between 8 and 24 hours. The placebo will also be dosed as one capsule on the morning of the long stage, prior to the race start, and one capsule at the end of the long stage.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 18 or over
4. In good general health as evidenced by readiness to participate in an ultramarathon
5. Ability to take oral medication and be willing to adhere to the study regimen
6. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening.

Exclusion Criteria:

1. Unable to read or understand English
2. Under 18 years of age
3. Pregnancy or lactation
4. Known allergic reactions to components of the investigational drugs
Comparison of Karydakis and Limberg Flap Treatment of Pilonidal Sinus in Adolescent. a Prospective, Randomised Study

Pilonidal sinus disease (PSD) is a chronic inflammation and infection of the sacrococcygeal region. Produces clinic findings with abscess and discharge in the sacrococcygeal region or painful sinus tract in the natal cleft. Its incidence rate among Turkish servicemen is reported to be 8.8% in a study. Although pilonidal sinus disease is common in men, this is the opposite in adolescence. Because adolescent girls are 2 or 3 times more.

Karydakis flap and Limberg flap operations widely preferred in recent years in the surgical treatment of PSD. In our study, we aim to compare these two techniques prospectively and randomly.

The best treatment technique for pilonidal sinus disease (PSD) is still controversial. While some researchers prefer minimally invasive methods, some researchers prefer surgical treatment. The most important concern in surgical treatment options is the prolongation of the disease recovery time and recurrence of the disease. Complications that may develop after treatment prolong the treatment period. The aim of this prospective, randomized study was to compare the results of the widely used Limberg and Karydakis flap operations in recent years. The parameters that will be used in the comparison will be an infection, recurrence and wound decomposition.

Eligibility Criteria:
Inclusion Criteria:

* Pilonidal sinus disease

Exclusion Criteria:

* Other disease than pilonidal sinus disease.
DNA Analysis From Isolated Cardiomyocytes in the Molecular Diagnosis of Arrhythmogenic Right Ventricular Cardiomyopathy/Dysplasia

The main objective of this study is to assess if it is possible, at the end of endocardial voltage mapping, to accurately collect intact cardiomyocytes and to isolate high quality DNA allowing molecular testing of selected genes involved in arrhythmogenic right ventricular cardiomyopathy/dysplasia.

Arrhythmogenic right ventricular cardiomyopathy/dysplasia is associated with mutations in genes encoding proteins from desmosomes and is characterized by a large expression variability. The classical molecular diagnosis from blood cells fails to identify mutations in around 30% of patients. Probes used for endocardial voltage mapping allow to collect some cardiomyocytes which could be used for DNA analysis.

The aim of this project is to investigate if cardiomyocytes can efficiently be collected during endocardial voltage mapping in patients with arrhythmogenic right ventricular cardiomyopathy/dysplasia. Thirty patients suffering from arrhythmogenic right ventricular cardiomyopathy/dysplasia cardiac and needing endocardial voltage mapping for disease diagnosis and/or prognosis assessment will be included. The main outcome will be the percentage of patients in whom mapping will allow to collect intact cardiomyocytes from which high quality DNA extraction will be achieved. Other outcomes include the identification of new mutational mechanisms as somatic mosaicism in selected genes (PKP2, DSCG2 DSP) and the feasibility of epigenetic analysis of these genes.

Eligibility Criteria:
Inclusion Criteria:

* patients needing endocardial voltage mapping in the context of arrhythmogenic right ventricular cardiomyopathy/dysplasia diagnosed using current criteria

Exclusion Criteria:

* Patient under 18 years, pregnant women and patients under legal protection
Zero-ischemia Robot-assisted Partial Nephrectomy Using Near-infrared Fluorescence

Patients with renal cancer are commonly treated by robot-assisted partial nephrectomy. Renal artery clamping is commonly required inducing kidney ischemia during surgery. It impacts parenchymal and renal function. This study aims to compare a new surgical procedure in order to reduce ischemia effect and preserve renal function after partial nephrectomy for renal tumour.


Eligibility Criteria:
Inclusion Criteria:

* candidate for a robot-assisted partial nephrectomy for renal tumour
* patient affiliated to social security
* signature of the informed consent

Exclusion Criteria:

* proven or suspected allergy to the indocyanine green
* coagulation disorder contraindicating robot assistance in the partial nephrectomy
* medical pathology contraindicating pneumo-peritoneum
* multiple tumors
* horseshoe kidney
* exclusion period of another interventionnal study
* protected person referred to in Articles L1121-5 to L1121-8 of the Code of Public Health
Prospective Observational Study of SynCone® Concept

The aim of this prospective observational study will be to evaluate patient-related outcomes, clinical, microbiological and peri-implant immunoinflammatory mediators in completely edentulous patients rehabilitated with delayed loaded overdentures prostheses. The investigators hypothetize that this system could restore edentulous patients with healthier mucosal concerning clinical, microbiological and immunoinflammatory parameters, besides to promote improvement in patient satisfaction and quality of life.

This prospective observational study will include fifteen edentulous patients rehabilitated with conventional dentures. Patients will receive four to six maxillary implants loaded three months after surgery. Clinical, microbiological and immunoinflammatory parameters will be evaluated at baseline, three, and six months following overdenture prosthesis. Patient-centered/reported outcomes concerning general satisfaction with the prostheses as well as comfort, ability to speak, stability, esthetics, ease of cleaning and occlusion, will be evaluated at baseline (conventional denture evaluation) and after 6 months (overdenture evaluation).

Eligibility Criteria:
Inclusion Criteria:

* subject has total edentulous maxilla.
* subject whose dental extractions occurred at least 6 months before treatment.

Exclusion Criteria:

* pregnancy, lactation, smoking or ex-smokers, systemic conditions that could affect bone metabolism (e.g., immunologic disorders, diabetes), use of anti-inflammatory, biphosphonate, and immunosuppressive medications, subjects that required bone grafts before/during implant surgery.
A Clinical Trial of Decitabine in Patients With Myelodysplastic Syndrome

The purpose of this study was to determine which of the doses of decitabine maximizes genomic demethylation in patients with Myelodysplastic Syndrome (MDS).

Phase I: The purpose of this study was to determine which of the subcutaneous doses of decitabine administered twice daily for 5 days maximizes genomic demethylation in patients with MDS

Phase II: To evaluate hematological responses at the dose selected in the Phase I portion of the study.

Note: This study was planned as Phase 1/2 study but only the Phase 1 part was conducted due to a change in product development strategy

Eligibility Criteria:
Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
2. Confirmed diagnosis of MDS or non-proliferative chronic myelomonocytic leukemia (CMML).

Exclusion Criteria:

1. Prior therapy with decitabine or azacytidine (Vidaza).
2. Experimental or standard drugs for the treatment of MDS within 28 days of the first day of study drug treatment.
3. Clinically significant anemia.
4. Prior history of malignancy other than MDS.
5. Any active infection.
6. Radiotherapy within 14 days prior to study enrollment.
iLookOut for Child Abuse -Online Learning Module for Early Childcare Providers

Phase 1 was a randomized control trial that used a test-retest model to evaluate the impact of iLook Out for Child Abuse, an online, interactive learning module about reporting suspected child abuse. Delivered via a learning management system to early childhood professionals who work with infants and young children, this study assessed iLookOut's effect on 1) knowledge about reporting suspected child abuse; 2) attitudes toward reporting suspected child abuse; and 3) preparedness to protect children at risk.

Findings from Phase 1 were that iLookOut will improved knowledge, changed attitudes, and increase self-reported preparedness of early childhood providers to report suspected child abuse.

Phase 2 of this trial is an open-enrollment study that records pre-/post- data on the same measurements as Phase 1, and is available for use (free of charge) for all childcare providers in Pennsylvania at https://www.ilookoutforchildabuse.com.

Despite their daily interactions with young children, little research has been conducted into early childhood professionals' (ECPs') knowledge of, and attitudes towards, reporting of child abuse/neglect. This study:

1. Evaluates the effectiveness of the online learning module, iLook Out for Child Abuse, created to train and inform early childhood providers about reporting suspected child abuse;
2. Identifies early childhood providers' current knowledge regarding Pennsylvania law on mandated reporting of suspected child abuse;
3. Explores the factors influencing early childhood providers' current knowledge and attitudes;
4. Evaluates the impact of an online educational program on early childhood providers' knowledge, attitudes, and patterns of decision-making regarding mandated reporting of suspected child abuse;
5. To explores the factors influencing the impact of an online educational program on early childhood providers' knowledge and attitudes regarding mandated reporting of suspected child abuse

Eligibility Criteria:
Inclusion Criteria:

* Paid or volunteer staff at childcare facility

Exclusion Criteria:

* Younger than 18 years of age