cyrilzakka/clinical-trials huggingface dataset:
Advanced Refractory Solid Tumors With TP53 Mutations Register Study

The efficacy and safety of the PARP inhibitor in combination with the VEGFR inhibitor will be investigated in advanced refractory solid tumors patients with TP53 mutation .

TP53 is a well-known tumor suppressor gene. Multiple studies have demonstrated that TP53 mutations are poor prognostic factor in advanced solid tumor, the TP53 gene is frequently inactivated by mutation in a majority of human tumors. However, no effective TP53 -based therapy has been successfully translated into clinical cancer treatment. So, investigators intend to review and evaluate the efficacy and safety of the PARP inhibitor in combination with the VEGFR inhibitor for TP53 mutation in advanced refractory solid tumors patients from a real-world population.

Eligibility Criteria:
Inclusion Criteria:

1. Is equal to or greater than 18 years of age.
2. Histologic or cytologic confirmation of advanced refractory solid tumors with no standard treatment options, including some patients with advanced disease in reduced general condition (Eastern Cooperative Oncology Group (ECOG) 3 and 4).
3. Patients with measurable or evaluable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
4. Patients must be able to provide blood samples or tissue samples for NGS (Next Generation Sequencing) testing for understanding the TP53 gene status. The amount of blood and tissue samples should be able to meet the requirements of DNA extraction and quality control.
5. Adequate baseline organ system function.
6. Patients could receive treatment program from MTB (Molecular Tumor Board).
7. No prior treatment with PARP combined with VEGFR inhibitions.
8. Ability to understand and the willingness to provide a written informed consent document.

Exclusion Criteria:

1. Women who are pregnant or breastfeeding.
2. Prior anti-cancer therapy or radiation therapy within 2 weeks prior to enrolment. Palliative radiotherapy to metastatic lesion(s) permitted providing that it has been completed at least 2 days prior to enrolment and no significant toxicity are expected.
3. Clinically significant (active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months prior to study enrollment; unstable angina, congestive heart failure or a serious cardiac arrhythmia requiring medication.
4. Active infection requiring systemic therapy.
5. Patients unable to swallow orally administered medication.
6. Prior treatment with PARP or VEGFR inhibitions.
7. According to the investigator'judgment, there are serious, uncontrollable risks to patients'safety, or associated diseases (such as severe diabetes, thyroid disease, infection, spinal cord compression, superior vena cava syndrome, neurological or psychiatric disorders and so on) that affect the patients completion of the study.
Inflammatory Markers in Exhaled Breath Condensates From Asthmatic Patients

This study aims to compare the inflammatory mediators in exhaled breathe condensates from allergic and non-allergic asthmatic patients.


Eligibility Criteria:
Inclusion Criteria:

1. Have been diagnosed as asthma at least 6 months before enrolled to the study
2. Known skin prick test results to aeroallergens ; either positive or negative
3. 15-65 years of age

Exclusion Criteria:

1. On oral or inhaled corticosteroids within 1 month before the study
2. Having asthma exacerbation
3. Being pregnant
4. Suffering from severe systemic disease/ in bad health
Single and Multiple Ascending Dose Safety Study of XPF-001 in Healthy Volunteers

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of single and multiple doses of XPF-001 in healthy volunteers.

The effect of food on the pharmacokinetics of XPF-001 will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects (Females of non-childbearing potential) with normal or clinically insignificant laboratory results, ECGs and physical examinations.

Exclusion Criteria:

* Subjects with a presence or history of any clinically significant disease.
* Subjects who have participated in and investigational drug trial within 60 days of admission.
* Subjects who have used tobacco or nictoine products in the 1 month prior to admission
* Females who are pregnant or breastfeeding
A Study of Saquinavir/Ritonavir in Liver-Impaired Patients With HIV Infection.

This 2 arm study will assess the effect of moderate liver impairment on the pharmacokinetics of saquinavir and ritonavir at steady state following administration of saquinavir/ritonavir 1000mg/100mg po bid in HIV patients. Saquinavir/ritonavir will be administered concomitantly with 2 to 3 active nucleoside reverse transcriptase inhibitors. The study will compare a group of HIV patients without known liver disease and a group with moderate liver disease. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-65 years of age;
* HIV infection;
* normal liver function, or moderate liver disease (Child-Pugh grade B);
* antiretroviral therapy naive and eligible to take antiretroviral treatment as per treatment guidelines, or treatment experienced for at least 4 weeks prior to first dosing.

Exclusion Criteria:

* severe ascites at screening, or Child-Pugh grade C;
* acute infection or current malignancy requiring treatment;
* taking any inhibitor of CYP3A4 (with the exception of anti-HIV drugs) within 14 days prior to first dosing;
* taking any inducer of CYP3A4 (with the exception of anti-HIV drugs) within 4 weeks prior to pharmacokinetic evaluation (day 14 or 28);
* evidence of resistance to saquinavir.
Effects of Changes in Fluid Status on Right Ventricular Volumes and Function

The purpose of this study is to evaluate the correlation between fluid volume status and right ventricular volume and function, in those with free pulmonary valve insufficiency after Tetralogy of Fallot (TOF) repair.

The purpose of this study is to measure the changes in Right Ventricular size and function with changes in preload, using cardiovascular magnetic resonance (CMR). Based on an intensive research and clinical observations the investigators hypothesize that changes in volume status cause a statistically significant difference in the Cardiovascular magnetic resonance (CMR) measured RV End Diastolic Volume (EDV), end-systolic volume (ESV), ejection fraction (EF) and pulmonary regurgitation (PR). The investigator hypothesizes that smaller changes will occur in left ventricular LV EDV, ESV, and EF.

1. To establish a correlation between the changes in preload volume status and RV size and function in patients with free pulmonary insufficiency (PI) after TOF repair using CMRI.
2. To assess the effects of preload status on the measured severity of pulmonary regurgitation (PR).
3. To assess the effects of preload status on the left ventricular (LV) size

This study will be conducted in compliance with this protocol, good clinical practice and the applicable regulatory requirements.

Eligibility Criteria:
Inclusion Criteria:

1. TOF patients who have had repair using a transannular patch.
2. Patients that present with free pulmonary insufficiency.
3. Are older than 18 years.

Exclusion Criteria:

1. Patients who have lesions predisposing to chronic volume overload (i.e. patients with significant residual postoperative ventricular septal defects (VSD), or large aorto-pulmonary collaterals or more than moderate tricuspid insufficiency) since all these hemodynamic conditions can influence the late function of the right ventricle and potentially affect the response of the right side of the heart in changes in volume status
2. Patients who had a valve sparing TOF repair and have less than free pulmonary insufficiency.
3. Patients who have significant residual right-sided obstruction (i.e. patients who have residual RVOT obstruction or significant residual branch pulmonary artery stenosis), as it is shown that residual pulmonary stenosis may protect from RV dilation and from deterioration of the RV function.
4. Patients who cannot be reconstructed with a transannular patch and/or require a right ventricle to pulmonary artery homograft for reconstruction including:

   * pulmonary atresia and VSD
   * patients with anomalous coronary crossing the right ventricular outflow tract (RVOT) and
   * patients with TOF-absent pulmonary valve syndrome.
5. Patients with renal failure and renal insufficiency
6. Patients with uncompensated heart failure
7. Cancer patients
8. Latex allergic patients
9. Patients with diabetes
10. Pregnant females
11. Prisoners
12. Individuals who lack consent capacity
Measurement and Assessment of Prolonged Grief Disorder in Asia

The overall project includes three sub-studies. Sub-Study I aims to develop the content of a new cultural sensitive grief questionnaire (International Prolonged Grief Disorder Scale, IPGDS Killikelly and Maercker, 2018) through interviews and focus groups with key (expert) informants and bereaved participants from Japan, Switzerland and China. The content will be piloted in paper and mobile app format. Sub - Study II aims to validate the new paper and mobile questionnaire in 200 participants from each culture using a battery of questionnaires and psychometric assessment. Sub-Study III will explore the relationship between grief and the cultural expression or repression of emotion. This will involve a battery of questionnaires about emotional expression and a short idiographic interview task administered to Swiss, Japanese and Chinese bereaved participants in paper and online format.

Objectives of the project:

The overall aim of this project is to develop three culturally sensitive measures of grief for use in Switzerland, China and Japan. Three sub-aims are described below:

Substudy 1: Development of the questionnaire Substudy 2: Psychometric Validation of the questionnaire Substudy 3: Relationship between emotional expression and grief The relationship between grief and the expression of emotion will be explored within and across the three cultures.

Outcomes of the project:

Sub-study 1:

1. Three new culturally sensitive versions of a Prolonged grief disorder measure (IPGDS) 1) Swiss 2) Japanese 3) Chinese versions: the structure and item content of this measure
2. Beta draft of a mobile app version of the IPGDS questionnaire

   Sub-study 2:
3. Psychometric properties of the IPGDs: specific outcomes including statistical confirmation of the reliability (interrater reliability, test/retest, internal consistency) and validity (criterion, content validity, construct validity) of the IPGDs

   Sub-study 3:
4. Identification and documentation of emotional expression differences in Chinese, Japanese and Swiss culture that may impact on assessment of grief and could inform clinical assessment procedure.

Eligibility Criteria:
Inclusion Criteria:

* Swiss, Japanese, Chinese nationality or identity

  * English, German, Japanese, Cantonese or Mandarin speaking
  * Male and Female subjects 18 years to 75 years of age
  * Written informed consent by the participant after information about the project
  * Loss of a loved one (family or friend) at least 6 months prior, at most 10 years prior

Exclusion Criteria:

* • Severe mental health disorder (e.g. Major depression, suicidality, current schizophrenia),

  * currently in-patient,
Effect of Laser Acupuncture Alone or Combined With Pranayama Exercise on Inflammation in Allergic Rhinitis in Geriatrics

Allergic rhinitis (AR) represents one of the most common global health problems with seriously increasing incidence over the last decades.The goal of the treatment of rhinitis is to prevent or reduce the symptoms through reduction of the inflammation of affected tissues. Acupuncture and pranayama yoga exercises had reported a significant improvement in daily symptoms and an increase of symptom-free days in many studies enrolling geriatric patients.

Sixty Egyptian geriatrics with allergic rhinitis, after randomization, will be divided to 2 groups; the first 30-geriatric group will receive 3-session per-week laser stimulation for 8 weeks to some selected acupoints and daily pranyama exercises (nearly every session will be one hour, for 8 weeks), the second group will receive 3-session per-week laser stimulation for eight weeks to some bilateral selected acupoints. the stimulated points will be (LI 19, LI 20, ST2, and ST4. ST6, ST7, ST17, ST36, SI18, BL2, GB14, GV24 and EXHN5). Every acupoint will be stimulated with laser power of 100 mw that will be used on a spot area of 1 cm2 for 1 minute.

Eligibility Criteria:
Inclusion Criteria:

* geriatrics with allergic rhinitis

Exclusion Criteria:

* chest disease or heart disease or local congenital nose deformities participants received within-previous-eight-months self-prescribed or by-therapist prescribed complementary therapies
A Study of LY3415244 in Participants With Advanced Solid Tumors

The goal of this study is to evaluate the safety of LY3415244, a PD-L1/TIM-3 bispecific antibody, administered as monotherapy to participants with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* For Phase 1a/b, histologic or cytologic confirmation of advanced solid tumor.
* For Phase 1a/b, biopsy of tumor samples are required. Newly obtained core or excisional biopsy of a tumor lesion prior to study enrollment and undergo a biopsy procedure during the study.
* Phase 1a, prior anti-PD-1 or anti-PD-L1 therapy or other immunotherapy is allowed.
* Phase 1b, prior anti-PD-1 or anti-PD-L1 therapy is required where anti-PD-1 or anti-PD-L1 is standard of care in respective tumor types if the following criteria are met:

  * Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy
  * Must have completely recovered to baseline level prior to screening from any adverse events (AEs) that occurred from receiving prior immunotherapy
  * Must not have experienced a Grade ≥3 immune-related AE or immune related neurologic or ocular AE, pneumonitis or cardiomyopathy of any grade while receiving prior immunotherapy
  * Must not have required immunosuppressive agent, other than corticosteroids for the management of an adverse event and not currently require maintenance doses of \>10 milligrams (mg) prednisone (or equivalent) per day
* Must have at least 1 measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
* Have adequate organ function.
* Have an estimated life expectancy ≥12 weeks, in the judgement of the investigator.

Exclusion Criteria:

* Have symptomatic central nervous system (CNS) malignancy or metastasis not requiring concurrent treatment, including but not limited to surgery, radiation, corticosteroids and/or anticonvulsants to treat CNS metastases, and their disease is asymptomatic and radiographically stable for at least 30 days.
* Have received a live vaccine within 30 days before the first dose of study treatment.
* If female, is pregnant, breastfeeding, or planning to become pregnant.
* Have a history or current evidence of any condition, therapy, or laboratory abnormality that might interfere with the participant's participation.
* Have moderate or severe cardiovascular disease.
* Have a serious concomitant systemic disorder that would compromise the participant's ability to adhere to the protocol, including known infection with human immunodeficiency virus (HIV), active hepatitis B virus (HBV), active hepatitis C virus (HCV), active autoimmune disorders, or prior documented severe autoimmune or inflammatory disorders requiring immunosuppressive treatment.
* Use of escalating or chronic supraphysiologic doses of corticosteroids or immunosuppressive agents (such as, cyclosporine). \[Use of topical, ophthalmic, inhaled, and intranasal corticosteroids permitted\].
* Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection.
* Evidence of interstitial lung disease or noninfectious pneumonitis.
Sweet Corn and Carotenoids

This study will assess the effect of daily yellow and white sweet corn intake on serum lutein and zeaxanthin concentrations. Skin carotenoid levels using the Veggie Meter will be assessed, and gastrointestinal symptoms and changes in fecal microbiota during a 4-week intervention period will be monitored.


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years of age
* Able to provide written consent in English
* Baseline Veggie Meter score of ≤ 250 (Scale from 0 to 850)
* Willing to adhere to study procedures

Exclusion Criteria:

* Baseline Veggie Meter score of \>250
* Corn allergy
* Current use of laxatives or antidiarrheal medications
* Previously or currently being treated for intestinal disease, including irritable bowel syndrome, Crohn's disease, ulcerative colitis, celiac disease, or gastrointestinal cancer
* Previous gastrointestinal surgery (e.g., gastric bypass, fundoplication, bowel resection)
* Current cancer treatment
* Current pregnancy
* Vegetarian diet
* Elite athletes or long-distance runners.
* Use of antibiotic drugs within 1 month of the screening visit.
Hemodynamic Estimation of the Result of the MitraClip Technique: Interest of the Ratio of Mean Arterial Pressure (MAP) to Pressure of the Mean Left Atrium (POG) (MitraPOG)

this research is based on the hypothesis that the measurement of the ratio of mean arterial pressure to mean left atrium pressure and of its evolution during the procedure, would make it possible to assess the immediate success of the procedure by supplementing the results of the ultrasound.

The main objective of this research is to define the percentage of improvement in the mean arterial pressure / mean left atrium pressure ratio at the end of the procedure to validate the success of the MitraClip procedure.


Eligibility Criteria:
Inclusion Criteria:

* Woman or man over 18 years old
* Patient with symptomatic mitral leakage (grade 3+ or 4+) at high surgical risk defined as:

  * Age ≥ 75 years and an STS score ≥ 6%, or, according to MVARC, at least 1 fragility index or at least 1 organ fragility criterion or at least 1 operative risk criterion. MVARC recommendations are defined in the appendix.
  * Age \<75 years and an STS score\> 8%, or, according to MVARC, at least 1 fragility index or at least 1 organ fragility criterion or at least 1 operative risk criterion. MVARC recommendations are defined in the appendix.
  * Patient rejected for surgery.
* Patient with a life expectancy of over 1 year.
* Patient affiliated or beneficiary of a social security scheme.
* Patient having been informed and having signed a written consent.

Exclusion Criteria:

* Patient with unfavorable ultrasound parameters (for example: patient with insufficient mitral surface).
* Patient with recent or active infection.
* Patient with a contraindication to the transseptal puncture.
* Patient with valve anatomy incompatible with the placement of the device.
* Patient with an anomaly of the tricuspid valve justifying a surgical intervention.
* Patient who has had a percutaneous cardiovascular procedure within the previous 30 days.
* Patient who had heart surgery in the previous 30 days.
* Patient with a history of surgery on the mitral valve.
* Patient having had a stroke in the previous 30 days.
* Patient participating in another clinical study.
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
* Pregnant, breastfeeding or parturient woman.
* Patient hospitalized without consent.
Comprehensive Acupuncture for Depressive Disorder With Comorbid Psychogenic Pain

Experimental and clinical studies have indicated that acupuncture has a good effect for depression and comorbid pain. The purpose of this research is to compare the effect of comprehensive electro-acupuncture therapy and western medicine citalopram for for depressive disorder with comorbid psychogenic pain. This research is a assessor blinded, randomized controlled trials. 60 patients will be randomly divided into comprehensive electro-acupuncture group and western medicine citalopram for 8 weeks treatment and the therapeutic effect is done at the end of 1,2,4,6,8 week.


Eligibility Criteria:
Inclusion Criteria:

* Conform with the diagnostic criteria of depression according to DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS (DSM-5TM)
* Age from 18 to 50 year-old
* Patients with the first onset depression
* Patients with mild-to-moderate depression scored 12-30 by Montgomery scale
* Patients with one psychogenic pain at least, and the degree of VAS is 3 or more
* Volunteer participants willing to cooperate and obeying the treatment

Exclusion Criteria:

* Pregnant woman
* Patients with severe primary diseases and acute diseases of heart, brain, liver, kidney and hematopoietic systems and infectious disease, malignant tumor
* Patients who can't stop taking drugs according to the requirement in the treatment period
* Patients with a history of schizophrenia and other mental disorders
* Patients with cognitive impairment or personality disorders
* Patients have serious suicide idea or suicidal behavior
Pulsed Radiofrequency Treatment Of the Gasserian Ganglion for tRigeminal nEuralgia: a retroSpective Study

With the Pulsed Radiofrequency treatment (PRF) Of the Gasserian ganglion for tRigeminal nEuralgia: a retroSpective Study (PROGRESS) the objective is to document the outcome of PRF (Pulsed Radiofrequency treatment) for patients with TN (Trigeminal Neuralgia), unresponsive to conservative treatment.

Primary objective:

To determine the proportion of patients in which PRF (pulsed radiofrequency) of the Gasserian ganglion for trigeminal neuralgia (TN) provides acute pain relief of at least 50% on the GPE (Global perceived effect) score (six weeks after treatment)

Secondary objectives:

- To determine the duration during which PRF of the Gasserian ganglion for trigeminal neuralgia provides a reduction of at least 50% on the GPE (Grade Point Equivalent) score.

Eligibility Criteria:
Inclusion Criteria:

* Patients with trigeminal neuralgia who underwent their first PRF of the Gasserian ganglion between 01/09/2013 and 31/08/2021

Exclusion Criteria:

* None