cyrilzakka/clinical-trials huggingface dataset:
Pre-Operative Pembrolizumab + Chemoradiation in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma

To investigate the safety and activity of preoperative pembrolizumab combined with chemoradiotherapy for resectable esophageal squamous cell carcinoma (ESCC) ,20 patients enrolled in Phase Ib PALACE-1(NCT03792347).The results showed that preoperative pembrolizumab with concurrent chemoradiotherapy was safe, did not delay surgery and induced a pCR in 55.6% of resected tumors. In this multicentre prospective study(PALACE-2),the investigators will evaluate the efficacy of preoperative pembrolizumab with concurrent chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma.

For locally advanced esophageal squamous cell carcinoma (ESCC), neoadjuvant chemoradiotherapy followed by surgery has been recommended as the optimal therapeutic strategy.Patients who achieved pathologic complete response(pCR) after receiving neoadjuvant therapy were more likely to have better survival. And the pCR rates was 43.2% reported in NEOCRTEC5010 trial, 49% with ESCC in the CROSS trial and 33.3% in FFCD 990130.

In Phase Ib PALACE-1(NCT03792347), the investigators firstly present that preoperative pembrolizumab combined with chemoradiotherapy followed by surgery is safe.All 20 patients have received PPCT successfully, except 1 patient who missed the last dose of chemotherapy due to leukopenia. Grade 3 and higher adverse events (AEs) were observed in 13 patients (13/20, 65%), and 1 patient had a grade 5 AE. The most frequent grade 3 AE was lymphopenia (12/13, 92%). Eighteen patients underwent surgery within 4-9 weeks after PPCT and the pCR rate was 55.6% (10/18).

This study (PALACE-2) will evaluate the efficacy of preoperative pembrolizumab with concurrent chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma in multicentres.

Eligibility Criteria:
Inclusion Criteria:

A patient will be eligible for inclusion in this study only if ALL of the following criteria apply:

1. Histologically confirmed cT2-T4a,N0-N+,M0 resectable esophageal squamous cell carcinoma.
2. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
3. Patients approve and sign the informed consent

Exclusion Criteria:

1. Patients with active autoimmune disease or history of autoimmune disease.
2. Patients who have a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications.
3. Subjects with a history of symptomatic interstitial lung disease.
4. History of allergy to study drug components.
5. Women must not be pregnant or breast-feeding.
6. Men with female partners (WOCBP) that are not willing to use contraception.
7. Patient has received prior chemotherapy, radiotherapy, target therapy and immune therapy for this malignancy or for any other past malignancy.
8. Underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events
Feasibility of a Youth-led NCD Risk Reduction Initiative in Selected Schools of Slums in Karachi, Pakistan: a Mixed-methods, pre-and Post-intervention Study

The study will occur in ten selected schools within Azam Basti and Mehmoodabad, organized into five sequential phases. Phase I involves identifying NCD modifiable risk factors among younger peers (Classes 5 and 6 students) using structured diaries. Phase II includes qualitative interviews with youth (Classes 9 and 10 students), parents, and stakeholders to discuss intervention material and delivery. Phase III comprises a one-day workshop to co-create an intervention. Phase IV involves three-day training for youth to understand and deliver the intervention to their peers. Finally, Phase V assesses the intervention's feasibility using a pre-and post-test design approach.


Eligibility Criteria:
Inclusion Criteria:

1. Both government and private schools
2. Schools that have classes 1 to 10 in one boundary
3. Schools who agree to take part in the qualitative interviews
4. Schools that permit to engage youth, their parents, and younger peers in the study for ten months
5. For youth: Students of classes 9 and 10 (aged 14 to 16 years)
6. For younger peers: Students of classes 5 and 6 (9 to 12 years)
7. Students who provide written informed assent followed by parental consent
8. Parents of youth and other stakeholders, including head teachers, schoolteachers, and canteen staff who provide written informed consent

Exclusion Criteria:

1. Schools currently enrolled in any NCD-related intervention program or any similar program during the last six months
2. For youth: Having any severe or chronic medical condition or disability that restricts active participation of students in the intervention co-creation and delivery
Early Saline Irrigation to Decrease Post-operative Endoscopic Debridement

Nasal saline is a common treatment adjunct in the post-operative setting for endoscopic sinus surgery. However, the ideal timing and quantity of irrigation in the early post-operative period remains unknown. Proposed benefits of early, large volume irrigation include removal and softening of crusts, resulting in improved mucociliary clearance. The potential benefit of early large volume saline irrigation on post-operative day three to ease or reduce the need for early post-operative debridement has not been studied.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Diagnosis of CRS with or without polyposis
* Undergoing bilateral endoscopic sinus surgery
* Availability of pre-operative CT paranasal sinuses

Exclusion Criteria:

Patients with diagnosis of:

* Primary ciliary dyskinesia
* Immunodeficiency
* Cystic fibrosis
Continuos Body Temperature Monitoring

This is a nonrandomized, diagnostic, single-center, pilot study, with one group of participants. The aim is to examine the effectiveness and safety of telemedicine system for continuous measurement of body temperature in adults. Up to 40 subjects will participate in this phase of the clinical trial. No stratification, nor randomization of subjects will be performed. Respondents who meet the inclusion criteria will be monitored for up to 72 hours plus 72 hours after removing the device. Namely, the device will be placed on their body and will be there until upt to 72 hours, and then it will be removed. The respondent will be monitored by the team for an additional 72 hours by the person in charge of the examination, for possible side effects.

Sensor will be placed in the axilar joint or a little below on the side. The device will be connected to a mobile phone. Member of the research team (principal researcher/co-researcher/ nurse in charge of examination) measures the temperature of the skin in the opposite armpit manually, ie with a gallium thermometer and records every 30-60 minutes. When body temperature starts to rise, a member of the research team measures the body temperature every 15-30 minutes. After reaching a stable temperature, the temperature is measured every 30-60 minutes. If the subject is given drugs to lower body temperature, the temperature is measured again every 15-30 minutes until the temperature stabilizes to a normal subfebrile state.


Eligibility Criteria:
Inclusion Criteria:

* A person of male or female sex
* Age 18 and over
* Ability to measure the patient's body temperature frequently
* People who are hospitalized due to any type of infection or any other diseases that result in variations in body temperature (rise, fall)
* Completed all potential diagnostics of the hospitalized patient (no interrupting the measurement of the telemedicine device)

Exclusion Criteria:

* Allergic to contact with plastic or silver
* Anatomical anomalies that prevent the placement of the system
* High-risk health conditions, intensive care and the like
* A pacemaker or other device on the skin or implanted in the body that emits light electromagnetic radiation
Study of WNT974 in Combination With LGX818 and Cetuximab in Patients With BRAF-mutant Metastatic Colorectal Cancer (mCRC) and Wnt Pathway Mutations

The purpose of this study is to assess the safety and anti-tumor activity of the triple combination of WNT974, LGX818 and cetuximab in BRAFV600-mutant mCRC with RNF43 mutations or RSPO fusions.

The design of this study is based upon the translational and pre-clinical data that suggest that Wnt pathway signals, increased due to RNF43 mutations or RSPO fusions, cooperate with the EGFR and BRAF signals to maintain the growth of BRAFV600 CRCs. Inhibition of these signals with the triple combination of WNT974, LGX818 and cetuximab may result in anti-tumor activity.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged ≥ 18 years
* Histological or cytological confirmed metastatic colorectal cancer
* Written documentation of KRAS wild-type status and BRAFV600-mutation with RNF43 mutation and/or RSPO fusion
* Progression of disease after at least one prior standard of care regimen or intolerant to irinotecan based regimens
* Availability of a representative tumor specimen (primary or metastatic, archival or newly obtained)
* Measurable disease as per RECIST v1.1
* Eastern cooperative oncology group (ECOG) performance status ≤ 2

Exclusion Criteria:

* Phase II only: Prior treatment with RAF inhibitors, Wnt pathway inhibitors, cetuximab, panitumumab, and/or other EGFR inhibitors
* Symptomatic brain metastasis. Patients previously treated or untreated for these conditions that are asymptomatic in the absence of corticosteroid and anti-epileptic therapy are allowed to enroll
* Current treatment with medications or consuming foods that are strong inhibitors or inducers of CYP3A4/5 or herbal medications and that cannot be discontinued at least one week prior to the start of treatment.
* Symptomatic or untreated leptomeningeal disease
* Acute or chronic pancreatitis
* Clinically significant cardiac disease
* Patients with any of the following laboratory values at Screening/baseline

  * Absolute neutrophil count (ANC) \<1,500/mm3
  * Platelets \< 100,000/mm3
  * Hemoglobin \< 9.0 g/dL
  * Serum creatinine \>1.5 x ULN or calculated or directly measured CrCl \< 50% lower limit of normal
  * Serum total bilirubin \>1.5 x ULN
  * AST/SGOT and/or ALT/SGPT \> 2.5 x ULN, (\> 5 x ULN if liver metastases present)
* Patients with impaired hepatic function as defined by Childs-Pugh class B or C
* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral WNT974/LGX818

Other protocol-defined inclusion/exclusion criteria may apply
Study of Choline Chloride for Injection in Adolescent and Adult Patients With Intestinal Failure Receiving Long Term Parenteral Support

TARA-001-301 is a Phase 2b/3 randomized Open-Label Dose-Selection study with an Open-Label Extension and randomized Double-Blind, Placebo-Controlled Study with Open-Label Extension to investigate the safety and efficacy of Choline Chloride for Injection (Low Dose and High Dose) versus Placebo in adolescents (ages 12 to \< 18 years of age) and adults (≥ 18 years of age) with intestinal failure receiving long-term PS when oral or enteral nutrition is not possible, insufficient, or contraindicated.

Participants will be enrolled in one of 2 parts, each part will be followed by an open-label extension period of approximately a year.

Part 1: Open-Label Dose-Selection Phase Part 2: Double-Blind, Placebo-Controlled Phase

The purpose of the Open-Label Dose-Selection Phase is to evaluate the safety, tolerability, how Choline Chloride for Injection (study drug) is distributed in the body, and to select 2 of 3 doses for testing in the Double-Blind, Placebo-Controlled Phase.

The purpose of the Double-Blind, Placebo-Controlled Phase is to assess the safety of the study drug and how well the study drug works at the 2 selected dose levels.


Eligibility Criteria:
Key Inclusion Criteria:

* Male or female 12 years of age or older at the time of signing the informed consent
* Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements, prior to study entry.
* Individuals with intestinal failure receiving long-term PS when oral or enteral nutrition is not possible, insufficient, or contraindicated who are receiving stable PS at time of screening and for the duration of the study; Note: Long-Term PS = Participant must have been receiving PS for at least 6 months prior to screening and requiring PS at least 3 times per week
* Females of childbearing potential must have a negative urine pregnancy test at screening

Key Exclusion Criteria:

* Patients taking steatogenic medications for ≥ 12 weeks in the past 12 months; those taking any medicine that could affect the measurement of hepatic steatosis within 12 weeks prior to study entry
* Evidence of systemic active infection at the time of dosing
* Participants intending to take non-study drug choline supplements or choline-containing multivitamins during the course of the study
* Participants unwilling to limit alcohol intake to no more than 20/g a day for 24 hours prior to their screening visit and for the duration of the study
* Active malignancy (excluding basal cell skin tumor, low or very low risk prostate cancer, cervical carcinoma in situ and local resected cervical cancer)
* Clinically significant renal disease
* Low B12 or low serum folic acid levels that are less than the normal range
* Fulminant liver failure, with active bleeding and/or encephalopathy
Correlation of Pupillary Diameter Changewith Age and Anterior Chamber Depth After Cataract Surgery

PURPOSE: To assess the correlation between the change in pupil diameter, age and depth of the anterior chamber after 3 months of cataract surgery both in photopic and mesopic conditions. And study the changes of the pupillary diameter at 3 months after surgery in the two light conditions

Healthy patients who are going to be operated on for cataracts are expected to take part in the study. If during the clinical study the minimum number of patients established in the protocol is exceeded, new samples will continue to be registered until the end of the established period.

The sample selection mechanism is by consecutive recruitment during the study period (in order of arrival at the medical office). Patients are operated bilaterally in a period not exceeding 15 days and it will get the variables of both eyes. A simple random sampling will be used for the choice of single eye data per patient.

Eligibility Criteria:
Inclusion Criteria:

* Both sexes with age equal to or greater than 45 years
* Diagnosed cataract N1, C1, P1 or worse in some eye.
* Patients who will be operated on both eyes.
* Patients who have not been diagnosed with diabetes mellitus.
* Patients who have given their informed consent to take part in the study.

Exclusion Criteria:

* Age under 45 years.
* Patients with anisocoria, neurological disorders, diagnosed with diabetes mellitus, glaucoma or another eye disease.
* Patients with complications during and after cataract surgery.
The Fundamentals of Communication in Surgery

The goal of this observational study is to evaluate the impact of the FCS curriculum on achieving the learning objectives and resident reported self-efficacy with communication skills and determine the scalability of the training across a range of general surgery training programs

The researchers have developed a 5-year curriculum for surgical trainees called the Fundamentals of Communication in Surgery (FCS). The training includes core communication skills, e.g., expressing empathy, and frameworks to support informed consent and serious illness conversations, specifically Best Case/Worst Case and Better Conversations. The curriculum provides one developmentally appropriate two-hour session for each of the five years of surgical training. Because the training is skills based (e.g., scenario planning) and not procedure based (e.g., goals of care conversations) exercises are focused on specific techniques that build over subsequent sessions.

Researchers will invite 1-3 surgical attendings per site with an interest in surgical education to serve as trainers for the FCS curriculum.

All general surgery trainees at each institution will have access to the training program as part of their regularly scheduled educational curriculum, regardless of training year or status as a categorical resident. If there is interest, researchers will provide access to the curriculum to fellows and residents in affiliated programs, e.g., plastic surgery.

Researchers will invite site personnel who have roles related to surgical education including the program director and associate program director (if applicable), 2 to 3 attending surgeons who have high contact with residents in urgent care settings (e.g., emergency general surgery), 1 to 2 members of the education coordination team.

Eligibility Criteria:
Inclusion Criteria:

* surgical attendings with an interest in surgical education
* surgery trainees

Exclusion Criteria:

* none
Study of Proton Versus Photon Beam Radiotherapy in the Treatment of Head and Neck Cancer

Compared to IMRT, PBRT is thought to give less radiation exposure to the surrounding healthy tissues. It is possible that side effect rates with PBRT will be lower or the same compared to IMRT, but this has not been well studied to date. Although both of these radiation therapies have been used in the past to treat head and neck cancer, this research study will compare the effects of these two different radiation treatment modalities with each other to see whether PBRT is better, the same or worse than IMRT.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18.
* Histopathologically confirmed diagnosis of one the following cancer types:

  * Salivary gland cancer
  * Skin cancer
  * Melanoma
* HNSCC that require ipsilateral radiation
* Patients must be a candidate for ipsilateral radiation therapy.
* Karnofsky performance status ≥70.
* Negative pregnancy test for women of childbearing potential (\<51 years of age) as per institutional policy.

Exclusion Criteria:

* Any prior head or neck irradiation.
* Physician recommendation of bilateral neck radiation.
* Non-resectable disease
* Physician recommendation of mucosal radiation
CEST in Low-grade Glioma Study

Low grade gliomas (LGGs) are malignant, infiltrative and incurable brain tumours that typically present in the younger population. This project proposes to use non-contrast metabolic "Saturation Transfer" (ST)-MRI to evaluate LGG tumour progression and aims to predict early changes in LGG. Early identification of LGG patients whose tumours will progress will permit early interventions. ST-MRI does not involve any intravenous injection of contrast and which acquires metabolic information not seen by standard MRI.

Please see trial details below:

Eligibility Criteria:
Inclusion Criteria:

1. Be at least 12 years of age;
2. Diagnosed with:

   1. Cohort A (pre-surgical): Suspected LGG (oligodendroglioma or astrocytoma), based on any combination of histological, molecular, radiological, and/or clinical findings; or
   2. Cohort B (post-surgical): IDH1/2-mutant or IDH-wildtype (WT) low-grade glioma candidate for observation
3. No contraindications to MRI;
4. eGFR \> 30 ml/min;
5. No prior chemotherapy or radiation therapy;
6. No need for upfront treatment (surgery, chemotherapy, and/or radiation therapy)
7. Followed at either Sunnybrook Health Sciences Centre or at St Michael's Hospital

Exclusion Criteria:

1. Need for upfront post-surgical treatment with either chemotherapy and/or radiation therapy
2. Pregnancy
The Effects of Intravenous Anesthetics and Inhaled Anesthetics on Patients' Postoperative Sleep

Adequate sleep is necessary for physical and mental health of human being. Although surgery and anesthesia techniques have improved in resent years, postoperative sleep disturbance remains a challenging problem in surgical procedures1. Postoperative sleep fragmentation and poor sleep quality can not only result in hyperalgesia and a delay in postoperative recovery2, lack of sleep after surgery can also bring many potential adverse effects such as cognitive disorders (such as delusions, delirium), chronic pain, mood disorders, metabolic disorders, and pro-inflammatory changes3-5. Previous studies have reported that age, preoperative comorbidity and severity of surgical trauma were independent factors that associated with postoperative sleep disturbance6,7. Our prior studies have also found that patients are more likely to experience decreased sleep quality after receiving general anesthesia, which was characterized by a decrease in each sleep stage8. Propofol and sevoflurane are commonly used general anesthetics in clinical practice. The choice of anesthetic may also affect the cognitive outcome after surgery, but the results of clinical studies have always been contradictory. Some studies report that the cognitive results after inhalation are worse than those after intravenous anesthesia. And the incidence of dreaming was significantly higher in the sevoflurane anesthesia group compared to the propofol group9-11. Another study conduct among infants proved that compared with propofol-remifentanil, sevoflurane appears to be associated with less sleep disturbances in the first weeks after surgery12. Based on these conflicts, the aim of the current study was to compare the effect of propofol vs sevoflurane on early postoperative sleep quality and complications of patients receiving laparoscopic surgery after general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

ASA : GradeⅠtoⅡ Laparoscopic surgery

Exclusion Criteria:

history of sleep apnea; severe neuropsychiatric disorders; long-term use of sedatives or sleeping pills; can not implement multi-lead sleep monitoring and other sleep disorders