cyrilzakka/clinical-trials huggingface dataset:
Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation

This is Phase Ib/II, multicenter, open-label adaptive platform study of JDQ443 with select therapies in patients with advanced solid tumors harboring the KRAS G12C mutation.

JDQ443 will be considered "backbone" treatment in this trial and combined with selected therapies, or "partner(s)". The combination of a backbone and a partner will constitute a treatment arm. After dose escalation, treatment arms that reach a maximum tolerated dose /recommended dose and are determined to be safe may, but are not required to, proceed to Phase II to further explore safety, tolerability, and anti-tumor activity.

Eligibility Criteria:
Inclusion Criteria:

Dose Escalation:

- Patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors who have received standard of care therapy or are ineligible to receive such therapy.

Phase II:

* Patients with advanced (metastatic or unresectable) KRAS G12C mutant non-small cell lung cancer who have received platinum-based chemotherapy regimen and immune checkpoint inhibitor therapy, unless patient was ineligible to receive such therapy
* Patients with advanced (metastatic or unresectable) KRAS G12C mutant colorectal cancer who have received fluropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, unless patient was ineligible to such therapy.

All patients:

* ECOG performance status of 0 or 1.
* Patients must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the treating institution's guidelines.

Exclusion Criteria:

* Tumors harboring driver mutations that have approved targeted therapies, with the exception of KRAS G12C mutations
* Prior treatment with a KRAS G12C inhibitor is excluded for patients in a subset of groups in Phase II.
* Active brain metastases, including symptomatic brain metastases or known leptomeningeal disease
* Clinically significant cardiac disease or risk factors at screening
* Insufficient bone marrow, hepatic or renal function at screening Other protocol-defined inclusion/exclusion criteria may apply
Sleep, Autonomic Nervous System and Cardiorespiratory Capacity in Autism Spectrum Disorders Children (APAUTRES)

Autism Spectrum Disorders (ASD) is a neurodevelopmental disorder which involves social and behavioural impairments. Autonomic dysfunctions and disturbed sleep were often associated to ASD. The investigators proposed to explore the impact of physical activity on these disorders. In this context, it is necessary to characterize the cardiorespiratory capacities of ASD children in order to promote physical activity for this population. To examine potential differences between ASD and control children, some explorations were proposed: a maximal treadmill test, motor evaluation, and orthostatic test (for the evaluation of autonomic nervous system).

An actimetry during one week (evaluation of physical activity and sleep) completed this study in order to specify sleep characteristic and established the possible link between physical activity sleep characteristics and physical fitness in ASD children.


Eligibility Criteria:
Inclusion Criteria:

* children physically active
* children with an intellectual quotient \>70
* for autism children a diagnosis of autism in accordance to DSMV

Exclusion Criteria:

* history of cardio-vascular disease
* history of asthma or respiratory disease
* Behavior disorders.
* medical treatment by neuroleptic or melatonin or antiepileptic
Efficacy and Safety of a 7.5% Icodextrin Peritoneal Dialysis Solution in Once-Daily Long Dwell Exchange

The purpose of this study is to evaluate the efficacy and safety of a 7.5% Icodextrin peritoneal dialysis solution for once-daily long dwell exchange in patients undergoing Continuous Ambulatory Peritoneal Dialysis (CAPD) in Chinese uremic patients.Patients were divided into Dianeal group or Extraneal group for long dwell time. Net ultrafiltration, small solute clearance and relationship between different transport group were used to evaluate efficacy of Icodextrin. Physical examination, vital signs and laboratory tests were used to evaluate safety of Icodextrin.

A prospective, multicenter, randomized, double blind, parallel controlled study has been conducted for 5 weeks in 201 CAPD patients. These patients were randomized from 7 centers with 98 allocated to the Icodextrin group and 103 to the Dextrose group. Before study, conventional glucose-based solution was the only dialysate which can available in China. Extraneal® is one of peritoneal dialysate produced by Baxter which contains 7.5% Icodextrin. Patients involved the study were allocated to Dianeal group and Extraneal group in randomize. In Dianeal group, prescription was unchanged, while in Extraneal group, Extraneal dialysate was used instead of 2.5% Dianeal. Assessments at baseline, week 2, and week 4 included drain volume and levels of glucose, creatinine, and urea in the dialysate drained from the long dwell; physical examination; vital signs; drained body weight; laboratory analyses. Daily net peritoneal ultrafiltration, daily peritoneal creatine clearance and daily peritoneal urea nitrogen clearance were recorded prior to and 2 week, 4 week after commencing Extraneal.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing continuous ambulatory peritoneal dialysis (CAPD) for more than 90 days were included in the study.
2. Over the age of 18
3. Received a minimum of 6-8 liters of dialysis fluid per day and nighttime must lasted for 8-16 hours with 2.5% Dianeal® PD-2 or PD-4 dialysate, dwell volume was 2.0 liters before 30 days of screen visit
4. No acute/chronic exit infection or tunnel infection accompany with peritonitis infection before 30 days of screen visit

Exclusion Criteria:

1. Be sensitive to Icodextrin
2. Suffer from other serious disease
3. Attended other invention research which was approved by Ethics Committee
4. Used other drugs in trial 30 days before screen visit.
Clinical Study of Balloon Pulmonary Angioplasty for Patients With Chronic Thromboembolic Pulmonary Hypertension

Chronic thromboembolic pulmonary hypertension (CTEPH) is the fourth group of pulmonary hypertension (PH) according to clinical classification. Pulmonary endarterectomy（PEA) is the preferred treatment for patients with CTEPH, however, PEA has its limitations, it only applies to the thrombi in the main, lobar, or segmental pulmonary arteries for patients with CTEPH, and the postoperative residual PH is found to be of high percentage. With the development of interventional techniques, balloon pulmonary angioplasty (BPA) has been used to treat chronic thrombotic pulmonary hypertension (CTEPH) with favorable results and has been identified as an effective and safe treatment for technically inoperable CTEPH. Balloon pulmonary angioplasty (BPA) has been accepted as a therapeutic strategy in accordance with the 2015 ESC/ESR guidelines, especially for patients with technically inoperable, an unfavorable risk-to-benefit ratio of the PEA. This study was a single-center prospective study that collects 3 time points data (before BPA, after final BPA, and follow-up ) to verify long-term safety and efficacy of BPA, as well as comparing the efficacy with targeted medical therapy, evaluating the complications of BPA, the survival of patients, and the postoperative quality of life.


Eligibility Criteria:
Inclusion Criteria:

* technically inoperable for PEA in patients with CTEPH
* unfavorable risk/benefit ratio for PEA
* residual or recurrent PH after PEA
* aged over 18 years old

Exclusion Criteria:

* other groups of PH except for CTEPH
* severe renal insufficiency(eGFR\<30ml/min·1.73mˆ2)
* severe infectious diseases
* severe hemorrhagic tendency
* severe anaphylaxis of contrast
* pregnancy and lactation
* expected survival time is less than half a year due to tumor or other disease
Utility of Severity Scales in Clinical Practice in Children Hospitalized Due to Bronchiolitis.

Prospective observational study of patients hospitalized with bronchiolitis. The objective of our study is to compare the accuracy of commonly used clinical scales for bronchiolitis to predict relevant outcomes.


Eligibility Criteria:
Inclusion Criteria:

Children eligible for the trial must fulfil all of the following criteria:

1. Children admitted to the hospital with the clinical diagnosis of acute bronchiolitis, which is defined as an apparent viral respiratory tract infection associated with airway obstruction manifested by at least one of following symptoms:

* Tachypnoea (WHO definition).
* Increased respiratory effort manifested as follows:

  1. Nasal flaring;
  2. Grunting;
  3. Use of accessory muscles;
  4. Intercostal and/or subcostal chest wall retractions;
  5. Apnoe.
* Crackles and/or wheezing. 2. Aged 5 weeks - 24 months old.

Exclusion Criteria:

1. Diagnosis or suspicion of asthma.
Effects of Cyclic Variations in Altitude Conditioning (CVAC) on Wellness and Activity Measures

Cyclic Variation in Altitude Conditioning (CVAC) is a new technique that uses a pod-like device to expose users to controlled fluctuations in air pressure. It is designed to promote quicker altitude acclimatization, thus promoting improvements in exercise capacity at altitude and, possibly, at sea level. However, over the past few years, anecdotal stories from users of the device suggest that the CVAC treatments might be causing changes beyond the expected endurance exercise performance benefits. Therefore, the purpose of the study is to obtain data on some of the previous anecdotal claims regarding the device (e.g. increases in strength, improved glucose tolerance, reduction of neuropathic pain and decreased joint swelling) as well as to obtain broad questionnaire data in order to identify more specific variables to investigate in future studies.


Eligibility Criteria:
Inclusion Criteria:

* Healthy middle aged men at risk for metabolic syndrome

Exclusion Criteria:

* Uncontrolled hypertension,
* sensitive ears,
* anything that would preclude person from sustaining rapid pressure changes
Impact of Poplar Propolis on Metabolic Disturbances of Insulin Resistance

Propolis, a natural resinous mixture rich in polyphenols, produced by bees from a variety of plant sources, has shown significant therapeutic effects and may prevent the development of certain chronic diseases. Current evidence supports the beneficial effect of these bioactive phytochemicals on the management of type 2 diabetes mellitus (T2DM) and other chronic diseases. The objective of this study is to evaluate the effect of poplar propolis extract powder (PPEP) on glucose homeostasis and other clinical parameters in insulin-resistant patients (diagnosed by HOMA-IR index \> 1.85 for men and \> 2.07 for women).

Backgroud: Propolis, a natural resinous mixture rich in polyphenols, produced by bees from a variety of plant sources, has shown significant therapeutic effects and may prevent the development of certain chronic diseases. Current evidence supports the beneficial effect of these bioactive phytochemicals on the management of type 2 diabetes mellitus (T2DM) and other chronic diseases. The objective of this study is to evaluate the effect of poplar propolis extract powder (PPEP) on glucose homeostasis and other clinical parameters in insulin-resistant patients (diagnosed by HOMA-IR index \> 1.85 for men and \> 2.07 for women).

Methods: The trial was a randomized, controlled, crossover, intervention study. Insulin-resistant patients (n=9) (8 women, 1 man), with a mean ± SD age 49 ± 7, were subjected to two periods of supplementation (propolis and placebo) for 3-months, separated by a 2-week washout period. The quantity of propolis administered was determined individually to reach 6 mg of polyphenols/kg. Fasting blood test and oral glucose tolerance test (OGTT) were performed before and after each treatment.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) ≥ 30 kg/m2
* Insulin resistance defined as a HOMA-IR index \> 1.85 for men and \> 2.07 for women

Exclusion Criteria:

* Presence of diabetes
* Recent weight change (≥ 5% in the last 3 months)
* Documented allergy to bee products and/or fish products
* Positive serology for human immunodeficiency virus or hepatitis
* High blood pressure
* Elevated transaminases (AST \> 40 IU/L ; ALT \> 45 IU/L)
* Low creatine clearance (estimated glomerular filtration rate \< 90 ml/min)
* Interfering treatment (cholesterol-lowering treatment, intestinal absorption modulating treatment, absorption modulating treatment and/or insulin sensitivity)
* Gastrointestinal tract surgery
* Pregnancy and / or lactation.
SNAP: Study Nutrients in Adult PKU

Phenylketonuria (PKU) is a rare inherited metabolic disorder, where subjects are born with a genetic deficiency in the phenylalanine hydroxylase enzyme (PAH), which leaves them unable to convert Phenylalanine (Phe) into Tyrosine (Tyr). PKU patients have specific dietary needs and must follow a restrictive diet in the aim of preventing toxic levels of the amino acid phenylalanine (Phe) accumulation.

The aim of this explorative cross-sectional study is to gain quantitative insights on blood nutrient levels of adult PKU patients on a protein substitute.

Eligibility Criteria:
- Inclusion Criteria:

Both PKU and Non-PKU comparison subjects:

1. Age ≥18 years
2. Willing and able to provide signed informed consent PKU specific inclusion criteria
3. PKU patients identified by newborn screening and started low Phe diet before 1 month age
4. Usage of at least one Phe-free protein substitute (i.e. an amino acid mixture including micronutrients) on a daily basis for at least 26 consecutive weeks up to Visit 1

   Non-PKU comparison subjects specific inclusion criteria:
5. Same age- (±3 years) and sex as an included PKU subject

   * Exclusion Criteria:

Both PKU and Non-PKU comparison subjects:

1. For women: Currently pregnant or lactating
2. Current psychiatric disorders
3. Current Substance Use Disorders (as described in DSM V)
4. Current use of psychotropic and/or inotropic medication
5. Omega-3, antioxidant, (multi)vitamin and/or (multi)mineral supplement use within six weeks prior to entry in the study
6. Severe hepatic, thyroid or renal dysfunction
7. No acute illnesses like flu, diarrhea, or vomiting (subjects should be symptom free for a week prior to V1)
8. Participation in any other clinical intervention studies involving test products concomitantly or within six weeks prior to entry into the study
9. Other family members taking part in this study

   PKU subject specific exclusion criteria:
10. Use of BH4, or drugs that may interfere with main outcomes

    Non-PKU comparison subjects specific exclusion criteria:
11. Any condition or special diet (e.g. vegan or vegetarian diet) that effects the metabolism and/or normal dietary pattern/intake
12. A first or second degree relative with inborn errors of metabolism
13. Living together with someone with inborn errors of metabolism (e.g. partner, spouse or roommate)
Prediction of Response to Treatment With Immunotherapy + Chemotherapy in Non-Small Cell Lung Cancer

This study seeks to evaluate a multiparametric test including 6 immunohistochemical markers (PD-L1, CD8, FoxP3, PD1, CD163, CD15) to predict the cumulative incidence of death or progression on treatment with pembrolizumab+first line chemotherapy in metastatic non-small cell lung cancer, regardless of the PD-L1 status and in the absence of ALK, ROS1 or EGFR alteration.


Eligibility Criteria:
Inclusion Criteria:

* 18 years at time of diagnosis
* Affiliation to a social insurance
* Obtaining the patient's non opposition
* Patients with non-small cell lung carcinoma, confirmed by anatomopathological, metastatic or locally advanced unresectable, not eligible for local curative treatment
* Cellular or tissue FFPE available
* Indication of treatment with pembrolizumab + first line chemotherapy in multidisciplinary consultation meeting
* No mutation of the EGFR gene, no rearrangement of ALK and ROS,
* At least one measurable tumor according to RECIST criteria

Exclusion Criteria:

* Tissue or cellular FFPE not available
* Systemic anti-neoplastic or immunotherapy previously received except neoadjuvant or adjuvant treatment completed 6 months or more
Benzodiazepine Taper with Cognitive Behavioral Therapy in Patients Using Prescription Opioids

Taking prescription opioids for pain together with benzodiazepines for the treatment of anxiety disorders is not recommended by the U.S. Food and Drug Administration (FDA) because of the elevated risk of serious complications, including fatal overdose. However, this concurrent prescription use continues to be prevalent, likely due to the high comorbidity between pain and anxiety disorders. Efforts are urgently needed to reduce benzodiazepine use among patients taking opioids. Cognitive behavioral therapy (CBT) is a first-line treatment for anxiety disorders, and represents a safer and more effective treatment for anxiety disorders compared to benzodiazepines. The proposed study aims to make minor adaptations to a CBT protocol to facilitate benzodiazepine tapering and to then conduct a 2-arm randomized clinical trial with primary care patients who receive benzodiazepine and opioid prescriptions. Participants will be randomized to receive a telehealth-delivered intervention consisting of a gentle, 12-week benzodiazepine taper (BZT) with either CBT or a health education control (HE). Participants will be assessed at baseline, several points throughout treatment, at post-treatment, and at a 2-month follow-up assessment on benzodiazepine use, opioid use, and anxiety symptoms. Should CBT + BZT outperform HE + BZT, this intervention could make a significant impact by reducing major consequences of concurrent use of opioids and benzodiazepines, including mortality.


Eligibility Criteria:
Inclusion Criteria:

* taking prescribed BZs for at least 3 months prior to baseline and have a positive UDS for BZs at baseline
* currently experiencing significant distress or impairment due to their anxiety symptoms (i.e., score ≥ 6 on the OASIS during screening
* have been prescribed opioids for at least 3 months for pain management and have a positive UDS for prescribed opioids at baseline
* are between 18-85 years old
* are fluent in English
* have access to a digital device with internet access for telehealth
* are willing to reduce BZ use.

Exclusion Criteria:

* pregnancy
* psychiatric symptoms requiring a higher level of care (i.e., severe suicidality, manic or psychotic symptoms not stabilized on medication)
* presence of any SUD other than tobacco use disorder, OUD (co-occurring with pain condition) or sedative/hypnotic use disorder)
* medical conditions that require ongoing treatment with benzodiazepines (e.g., certain seizure disorders)
* use of drugs other than BZs and opioids in the past 30 days (as indicated by UDS and self-report), with the exception of intermittent cannabis use (not meeting criteria for CUD) and use of alcohol above at-risk drinking cutoffs per US Dietary Guidelines
* marked cognitive impairment.
Effects of Balance Training With Gaze Stabilization Exercises in Elderly Patients With Chronic Dizziness

Effects of balance training with and without gaze stabilization exercises on clinical outcomes in elderly patients with chronic dizziness: A Randomized Controlled Trial

In older adults dizziness is a common condition which is associated with repeated falls, fear of falling, depression, anxiety and ultimately loss of independence during activities of daily living. The main objective of this research was to compare the effects of balance training with and without Gaze Stabilization exercises on clinical outcomes in elderly patient with chronic dizziness.Total 64 participants after referral from neurologist were recruited in this study. These participants were randomly assigned into two groups i.e. Group A (Gaze group) and Group B (control group) with 32 participants in each group by sealed envelope method. Gaze group performed balance exercises with gaze stability exercises. Gaze stability exercises are further classified as adaptation and substitution exercises. Adaptation exercises support long term changes with a purpose of decreasing symptoms and maintain postural stability. On the other hand the substitution exercises improving central preprogrammed movement of eyes. Basically gaze stability exercises are defined as habituation exercises which reduce the symptoms of provoking stimulus by continuous exposure to it whereas, group B performed balance exercises with saccade eye exercises.Balance training includes both static and dynamic balance exercises, aimed to improved balance and postural stability with gradually increasing to challenging task. Exercises in balance training included a) single leg balance on firm surface b) heel stand c) marching on firm surface d) toe stand e) tandem walk f) forward and backward walking from normal base of support to weekly progression and training from eyes open to eye close from stable to unstable surface. Berg Balance Scale, Disability Handicapped inventory and Activity Specific Balance Confidence Scale were used to measure outcome variables.

Eligibility Criteria:
Inclusion Criteria:

* Geriatric population
* Both Gender
* H/O chronic dizziness with normal vestibular function
* H/O age related balance impairment
* H/O impaired balance having a Berg Balance Scale (BBS) score between 35-45
* Participant have sufficient cognitive and communication skills

Exclusion Criteria:

* H/O insufficient communication skills to follow instructions
* H/O impaired vestibular function
* H/O Visual impairment
* H/O Severe hearing loss
* H/O mental disorder that could restrains the ability to concentrate during therapy
* H/O Other systematic diseases
* Any history of marked musculoskeletal impairment, lower limb injury, surgery other than age related changes and balance disorder due to other neurological conditions like Parkinsonism, stroke, multiple sclerosis etc. were excluded from the study
Gemcitabine and Carboplatin for Elderly Patient With Lung Cancer

A comparison of biweekly combination chemotherapy (gemcitabine plus carboplatin) with weekly gemcitabine in elder patients (\> 75) with previously untreated advanced non-small cell lung cancer. Primary objective is to determine the objective response rate (CR+PR by RECIST criteria) for biweekly gemcitabine and carboplatin combination chemotherapy versus weekly single gemcitabine as first-line therapy in elder advanced non-small lung cancer patients (\> 76 years) who have received no prior treatment for non-small lung cancer. As secondary objectives, adverse event profile, tolerability of biweekly gemcitabine and carboplatin combination chemotherapy, progression-free survival and overall survival will be evaluated in both patients with biweekly gemcitabine and carboplatin combination chemotherapy and weekly single gemcitabine.

The study hypothesis is that biweekly combination chemotherapy of gemcitabine plus carboplatin may improve the efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of histologically confirmed stage IIIB or IV non-small cell lung cancer
* Good performance status (ECOG 0-1)
* No previous treatment
* Age 76 years and older
* Adequate bone marrow, liver and renal functions
* No pregnant
* Measurable disease, defined as at least one lesion whose longest diameter can be accurately measured as \>=1.0 cm by spiral CT scan
* Provided written informed consent

Exclusion Criteria:

* Severe complications or a concomitant malignancy
* Prior and other concurrent radiotherapy, chemotherapy, immunotherapy, EGFR tyrosine kinase inhibitors
* Interstitial pneumonia or lung fibrosis
* Contraindicated gemcitabine or carboplatin
* Inappropriate patients for entry to this study, judged by the physicians