cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Platinum-based Chemotherapy Plus Immune Checkpoint Inhibitors for EGFR/ALK/ROS1 Mutant Lung Cancer

The investigators want to evaluate the Efficay and Safety of Platinum-based Chemotherapy with or without immune checkpoint inhibitors for EGFR/ALK/ROS1 Positive NSCLC who Failed from First-Line Standard Treatment.

The investigators want to evaluate the Efficacy and Safety of Platinum-based Chemotherapy with or without immune checkpoint inhibitors for EGFR/ALK/ROS1 Positive NSCLC who Failed from First-Line Standard Treatment.

This study will be divided into three cohorts. Cohort A for EGFR mutation NSCLC, Patient with NGS identified EGFR sensitive mutation NSCLC who failed from first line Osimertinib will be included.

Cohort B for ALK fusion NSCLC, Patient with NGS identified ALK fusion NSCLC who failed from first line Alectinib/Lorlatinib/Ceritinib/Ensartinib/Brigatinib will be included. All the patients will be divided two group,3'ALK and 3'ALK with retention of 5'ALK.

Cohort C for ROS1 fusion NSCLC, Patient with NGS identified ROS1 fusion NSCLC who failed from first line Crizotinib/Entrectinib/Ensartinib/Brigatinib will be included.

The investigators will collect the safety and efficacy data for all the patients.

The tissue and blood samples will be collected under the permission of the participate.

Single cell sequencing, DSP, RNA-seq and IHC will be performed to evaluate the TME.

Eligibility Criteria:
Inclusion Criteria:

1. Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.
2. Age ≥ 18 years.
3. Histologically or cytologically confirmed, Stage IV NSCLC.
4. EGFR/ALK/ROS1-sensitive mutations confirmed by an accredited local laboratory, progressed from first line systematic therapy.
5. ECOG 0-1.
6. Predicted survival ≥ 12 weeks.
7. Adequate bone marrow hematopoiesis and organ function
8. Presence of measurable lesions according to RECIST 1.1.

Exclusion Criteria:

Cancer-Specific Exclusions:

* Active or untreated central nervous system metastases.
* Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome.

General Medical Exclusions:

* Pregnant or lactating women.
* History of autoimmune disease.
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
* Positive test for human immunodeficiency virus.
* Active hepatitis B or hepatitis C.
* Severe infection within 4 weeks prior to randomization.
* Significant cardiovascular disease.
* Illness or condition that interferes with the participant's capacity to understand, follow and/or comply with study procedures.

Exclusion Criteria Related to Medications:

• Prior treatment with cluster of differentiation 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1, and anti-PD-L1 therapeutic antibodies.
Irrigation Endoscopic Decompressive Laminotomy

The classic laminectomy for surgical treatment of spinal stenosis has considerable morbidity .This is further magnified by the disease being more common in elderly with associated medical comorbidities and being usually global involving multiple levels.The purpose of this study is to present and to evaluate a new endoscopic technique named Irrigation Endoscopic Decompressive Laminotomy (IEDL) for lumbar spinal canal decompression.

In the IEDL group,2 portals 0.5cm were used one for the endoscope and the other for instruments. For every additional level one portal is added. The endoscope and instruments are directly placed over the surface of lamina without any dissection and saline under pump pressure is used to open a potential working space. Unilateral laminotomy and bilateral decompression under endoscopic vision is performed. In the microsurgical group, bilateral fenestration is performed in the usual manner

Eligibility Criteria:
Inclusion Criteria:

* neurogenic claudication,that correlated with moderate to severe spinal canal stenosis as shown on MRI and resistant to 3 months of conservative management .

Exclusion Criteria:

* predominant back pain or instability
Mask Usage and Physical Performance During COVID-19 Pandemic in Geriatrics

In the COVID-19 pandemic, the use of masks in daily life has become an important issue. The most important measure taken to prevent contagion is the use of masks. The aim of the study is to determine the effects of surgical masks used in every moment of life on physical performance in elderly individuals.

Physical performance measurements were carried out by a physiotherapist using the Senior Fitness Test (SFT). Participants were informed about the procedure of the test. All participants performed two evaluation sessions by the SFT with and without using a surgical mask. The participants were randomly selected to perform the test whether with or without the surgical mask at first. The sessions were held at least 24 hours apart to prevent fatigue.

Eligibility Criteria:
Inclusion Criteria:

* geriatrics who had a score of ≥24 in the Mini Mental Test
* which evaluates the cognitive levels of individuals over the age of 65
* who were sufficient to perform physical function tests
* who had not been diagnosed with COVID-19 before

Exclusion Criteria:

* participants with severe respiratory disease (tuberculosis, severe COPD or bronchiectasis),
* uncontrolled cardiac arrhythmia, unstable angina, heart failure, severe kidney disease, neurological disorders that could cause consciousness change
* whose disease could not be controlled with medication
Anesthesia for Dental Treatment in Cardiac Patients: Lidocaine Comparative Study

Prospective, randomized double-blinded study to investigate hemodynamic changes in valvular cardiac patients during dental treatment with the use of a local anesthesia containing epinephrine.

Patients with valvular disease constitute a group in which local anesthesia must be effective to avoid higher release of endogenous catecholamines that could trigger hemodynamic. The study was conducted in the Dental Department of the Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (Brazil). Patients were allocated into two groups through an aleatory numbered table: PL (plain 2% lidocaine, n= 31) and LE (2% lidocaine with 1:100.000 epinephrine, n= 28). The anesthetic amount was registered. DIXTAL monitor (São Paulo- Brazil) captured blood pressure, heart rate, oxygenation and electrocardiogram records.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acquired valvular disease

Exclusion Criteria:

* Patients having platelets counting lower than 70.000 or INR \> 3
Phase I/II Study of Avelumab in Pediatric Cancer Participants

This is a multi-center, open-label, international study to evaluate the dose, safety and tolerability, antitumor activity, pharmacokinetic and pharmacodynamics of avelumab in pediatric subjects 0 to less than 18 years of age with refractory or relapsed malignant solid tumors (including central nervous system tumors) and lymphoma for which no standard therapy is available or for which the subject is not eligible for the existing therapy.

The study was planned to be conducted in 2 parts: the dose-finding part (Phase I) and the tumor-specified expansion part (Phase II). However, Phase II was cancelled due to limited clinical benefit of PD-L1 monotherapy in pediatric participants.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects 0 to less than 18 years of age at the time of first treatment dose with histologically or cytologically confirmed solid malignant tumors (including CNS tumors) or lymphoma for which no standard therapy is available
* Confirmed progression on or refractory to standard therapy or no standard therapy available.
* Availability of archival formalin-fixed, paraffin-embedded block containing tumor tissue, or slides, or a fresh/recent tumor biopsy prior to avelumab treatment for subjects in Phase 2
* Adequate bone marrow, kidney, and liver function
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Prior therapy with any antibody or drug targeting T-cell coregulatory proteins
* Concurrent anticancer treatment or immunosuppressive agents
* Prior organ transplantation
* Significant acute or chronic infections
* Other significant diseases or conditions that might impair the subject's tolerance of trial treatment
* Other protocol defined exclusion criteria could apply
Effect of Administration of Combined Enteral Lactoferrin and Probiotic On Invasive Fungal Infections In Preterm Neonates

The risk for invasive fungal infections is high in very low birth weight (VLBW) infants (\< 1500 g) and highest for infants born at the youngest gestational ages who survive past the immediate postnatal period.

Invasive fungal infections (IFIs) represent an increasing cause of severe morbidity and mortality in most neonatal intensive care units.

Lactoferrin (LF) is secreted by epithelial cells into exocrine fluids: seminal fluid, tears, saliva, uterine secretions, and milk. LF is involved in innate immunity mechanisms with several documented anti-infective properties, including antifungal activity.

Probiotics are microorganisms that are believed to provide health benefits when consumed.

It is possible to adopt measures to modify the flora in our bodies and to replace the harmful microbes by useful microbes.

There are certain commercially available strains of probiotic bacteria from the Bifido bacterium and Lactobacillus genera when taken by mouth in daily doses possess treatment efficacy

Bovine LF alone or in combination of probiotics (Lactobacillus Delbrueckii and Lactobacillus Fermentum) can be used in prevention of invasive fungal infection in preterm neonates admitted to the NICU. So, this randomized interventional study aimed at evaluation of the efficacy and safety of enterally administered bovine LF alone or in combination of probiotics (Lactobacillus Delbrueckii and Lactobacillus Fermentum) in comparison to placebo in preterm neonates, through studying blood culture for fungal infection at enrollment, day 7, 14, 21 and 28 using Sabouraud agar for detecting Candida species and Hichrome agar to detect other fungal types ( primary outcome), and to compare length of hospital stay (LOS), use and duration of drug intake as antibiotics and inotropes, use and duration of mechanical ventilation, rate of increase of enteral feeding, time to reach full enteral intake, signs of feeding intolerance, complete blood count (CBC), C reactive protein (CRP), packed red blood cell transfusion (PRBCs) and mortality between the 3 groups as (secondary outcome).

Eligibility Criteria:
Inclusion Criteria:

* 80 preterm
* ≤ 36 weeks gestational age
* \>/ = 72 hours of life

Exclusion Criteria:

1. Nothing per os
2. Congenital anomalies.
3. Suspected inborn error of metabolism.
4. Prophylaxis antifungal drugs
Safety And Efficacy Investigation Of The Effects Of ClearLift Q-Switched Nd:Yag 1064nm Laser Module In The Treatment Of Facial Skin Wrinkles

Alma Lasers ClearLift is a fractional non-ablative Q-Switched laser, allowing practitioners to use the benefits of a high intensity QS laser for the treatment of aged skin. Alma Harmony ClearLift uses a fractional QS laser to achieve a deep mechanical effect beneath the epidermis via a photoacustic effect. This creates a controlled dermal wound while leaving the epidermis intact. The wound healing process stimulates growth of new collagen, skin contracture and tightening. This procedure is virtually painless with no downtime and is safe for all skin types.

Based on this background, we have considered an interest to design a study aimed at assessing the efficacy and safety of a treatment course with ClearLift Module in patients with facial skin wrinkles


Eligibility Criteria:
Inclusion Criteria:

* Female subjects aged ≥ 35 and ≤ 55 years
* Presence of type 1-3 facial skin wrinkles, according to the Glogau scale;
* Subjects in reasonably good general health, according to Investigator's judgment;
* Subjects who agree to avoid tanning during the entire investigational period;
* Subjects who agree to avoid any other facial procedure during the entire investigational period; including but not limited to: injectables or threads, peeling of any kind, dermabrasion, facial hair removal or application of any cosmoceutical/pharmaceutical without the consent from the PI only.
* Subjects able to understand the full nature and the purpose of the investigation, including possible risks and side effects, able to cooperate with the Investigator and to comply with the requirements of the entire investigation (ability to attend all the planned investigation visits according to the time limits included) based on Investigator's judgement.
* Subjects willing to sign an informed consent, consent to use their photos for future scientific or marketing purposes, according to the sponsor's needs.

Exclusion Criteria:

* Subjects with active infections;
* Subjects with history of keloid scarring or hypertrophic scar formation;
* Subjects with previous medical treatment of the area, or oral retinoid drug prescribed within the past six months;
* Subjects who have been tanning within the past 30 days;
* Previous surgical treatment of the area selected for the treatment with the investigational device;
* Subjects with any inflammatory skin condition e.g., eczema, active herpes simplex, etc. at the treatment site;
* Subjects with presence of tattoos at the treatment site;
* Subjects with skin cancer or any other cancer and/or any cancer drug therapy (such as ducabaxine, fluorouracil, methotrexate, etc.);
* Subjects with history of autoimmune disorder or evidence of immunosuppression;
* Subjects with cellulitis;
* Subjects with collagen vascular diseases;
* Subjects with thrombocytopenia;
* Subjects with peripheral vascular disease;
* Subjects with Melasma;
* Pregnant or lactating subjects.
Pain Modulatory Profiles in Stretching

The purpose of this study is to characterize immediate changes in pain sensitivity during stretching to the point of pain, stretching in a pain free range, and a cold water immersion task. Participants will attend three sessions during which they will undergo pain sensitivity assessment and complete the assigned intervention.


Eligibility Criteria:
Inclusion Criteria:

* Pain Free

Exclusion Criteria:

* Non-English speaking
* Regular use of prescription pain medications
* Current or history of chronic pain condition
* Currently taking blood-thinning medication
* Any blood clotting disorder, such as hemophilia
* Systemic medical condition known to affect sensation, such as uncontrolled diabetes or neurological conditions
* Any contraindication to the application of ice, such as: uncontrolled hypertension, cold urticaria, cryoglobulinemia, paroxysmal cold hemoglobinuria, circulatory compromise
* Not physically ready to exercise without a medical exam as indicated by the Physical Activity Readiness Questionnaire Plus (PAR-Q+)
* Surgery, injury, or fracture to the neck or upper extremity within the past 6 months
* Unable to perform the stretch
* Unable to attend all three sessions
Study of SU011248 in Patients With Advanced Kidney Cancer

To determine the objective tumor response of single-agent SU011248 at a dose of 50 mg orally once daily for 4 consecutive weeks and 2 weeks rest, repeated every 6 weeks in patients with metastatic Renal Cell Cancer (RCC).


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven renal cell carcinoma with metastases with a component of clear cell histology

Exclusion Criteria:

* Any cellular therapy (LAK, TIL, DC), any vaccine therapy, mini-transplantation, or systemic molecular-targeting therapy for RCC.
Chinese Medicine for Treating Chronic Pharyngolaryngitis

A randomized, double-blinded, placebo-controlled clinical trial using a Chinese Medicine formula in treating Chronic pharyngolaryngitis. Subjects will be randomized into a treatment group or placebo group for 8 weeks, and then followed by an 8-week post-treatment visit.

Chronic pharyngolaryngitis (CP), also known as chronic pharyngitis, is defined as the inflammation of the pharynx, which is at the back of the throat. CP is a common disease characterized by dry throat, sore throat, pharyngeal itching, dry cough, and difficulty in swallowing. In Western medicine, common treatment regimens for CP include lozenges, antibiotics, lasers, and cryotherapy. However, the above treatment modalities may not be effective, and the disease is likely to bounce back repeatedly.

Chinese medicine has been used for the treatment of CP for a long time. Many studies have shown that treatment using Chinese herbal medicine is effective in relieving the symptoms of CP.

This study is to evaluate the efficacy and safety of oral Qingyan Lihou Decoction in relieving the clinical symptoms of patients with CP.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or above (Chinese subjects only);
* Persistent symptoms of pharyngitis (sore throat, globus, dry throat, dry cough, throat irritation) for more than 3 weeks;
* Determined to be the following Chinese medicine syndromes by Registered Chinese Medicine Practitioners (RCMPs): Wind-heat invading the upper-jiao, or phlegm heat or Yin deficiency;
* Visual analog scale (VAS) score for pain ≥ 50 mm;
* Numeric rating scale (NRS) ≥ 6; and
* Be able to give voluntary written informed consent.

Exclusion Criteria:

* Known severe medical conditions, such as cardiovascular, liver or renal dysfunction, diabetes mellitus, cancers, cerebrovascular diseases, blood system diseases;
* Concomitant use of steroids, nonsteroidal anti-inflammatory drugs (NSAIDs), anticoagulants, and immunotherapy within the past week;
* Impaired hematological profile and liver / renal function exceed the upper limit of the reference value by 2 times;
* Known Allergic rhinitis;
* Known Gastroesophageal Reflux Disease (GERD);
* Known cancer or suspected cancer of throat/oesophagus;
* Mechanical obstruction of the throat accountable for the symptoms;
* Known alcohol and/or drug abuse;
* Known allergic history to any Chinese herbal medicines; and
* Subjects who are known pregnant or lactating.
Capillary And Venous Accuracy: LifeScan Products vs Hospital Reference and YSI

This study is to evaluate accuracy between product platforms in the hands of users, comparing capillary to venous response vs YSI reference instrument as well as the local hospital analyser.

This study will gather data to:

* Determine if extreme bias can be observed between 3 candidate products for user accuracy.
* Assess the offset between venous blood samples versus capillary blood samples.
* Determine if there are measurable donor factors which influence the product bias.
* Assess any offset between YSI 2300 reference instruments and hospital laboratory analyser and impact on bias difference between BGM product types.

Eligibility Criteria:
Summary of Inclusion Criteria:

* Male or Female subjects with T1DM or T2DM.
* Must be able to read and sign the approved consent form.
* Registered into the LifeScan patient registry.
* Currently performing self monitoring of blood glucose ( SMBG)

Summary of Exclusion Criteria:

* Conflict of Interest - Prospective Participants will be excluded from enrollment if they are currently working for, have previously worked for, or have an immediate family member working for a company that manufactures or markets the type of products tested under the scope of this procedure.
The Lóa Study: a Brief Digital Intervention for Women with Intrusive Memories in the SAGA Cohort

Intrusive memories are sensory memories of a traumatic event(s) that spring to mind involuntarily, and can evoke strong emotions and disrupt functioning in daily life. Previous research has indicated that a brief cognitive intervention can prevent the development of intrusive memories as well as reduce the number of intrusive memories of long-standing trauma. Initial pilot work (using case studies and a pilot study, ClinicalTrials.gov identifier: NCT05089058) with women in Iceland indicates that the intervention is acceptable and feasible.

This randomised controlled trial will compare 3 arms to investigate if access to a cognitive task - either a brief self-guided imagery-competing task or a brief self-guided psychoeducation and signposting task - versus treatment as usual, can reduce the number of intrusive memories in week 5 (i.e., between-groups comparison), controlling for the number of intrusive memories in the baseline week.

The effect on the number of intrusive memories in week 5 (primary outcome), and other symptoms of post-traumatic stress, sleep and cognitive functioning will be tested.

This study is funded by the Icelandic Research Fund (11709-0270) and (200095-5601) and The Oak Foundation (OCAY-18-442).

Participants will be recruited from the Stress and Gene Analysis (SAGA) Cohort, a population-based, longitudinal study of Icelandic women (www.afallasaga.is, see selected publications in the reference box below).

A statistical analysis plan will be prepared prior to the first interim analysis using both frequentist and Bayesian analyses for statistical inference.

Regular monitoring will be performed by Vistor to verify that the study is conducted, and data are generated, documented and reported in compliance with the protocol, good clinical practice (GCP) and the applicable regulatory guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Part of the SAGA cohort
* Aged 18 or above.
* Able to read, write and speak in Icelandic.
* Have internet access.
* Willing to be contacted remotely and having access to a smartphone or computer
* Experience 3 or more intrusive memories in the past week
* Willing to monitor intrusive memories in everyday life
* Willing and able to provide informed consent and complete study procedures
* Willing and able to be contacted by the research team during the study period.
* Have not taken part in a previous study of this intervention from this research team (e.g., the Loa case series, feasibility trial or pilot RCT).

Exclusion Criteria:

* Have fewer than three intrusive memories during the baseline week.
* Suicide risk in the initial assessment (response of 'nearly every day' to item 9 on PHQ-9).
* Those undergoing other treatments for post-traumatic stress disorder (PTSD) or its symptoms will not be excluded, so the study will be as inclusive as possible.