cyrilzakka/clinical-trials huggingface dataset:
Arsenic Trioxide for Structural p53 Mutations

TP53 is the most frequently mutated gene in cancer, but these mutations remain therapeutically non-actionable. Previous study reported arsenic trioxide could rescue structural p53 mutations, endowing p53 mutations with thermostability and transcriptional activity. Under Vivo and Vitro experiments, arsenic trioxide could reactivate mutated p53 to inhibit tumor. This trial aimed to explore the efficacy and safety of arsenic trioxide in refractory cancer patients with structural p53 mutations.


Eligibility Criteria:
Inclusion Criteria:

* Malignant solid tumors diagnosed histologically;
* Solid tumor patients have no any standard choice after multiple line of therapy;
* Next-generation Sequence showed TP53 mutation;
* Expected survival ≥ 1 month;
* ECOG / PS score: 0-2, and the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL \<1.5 times the upper limit of normal (ULN); Liver ALT and AST \<2.5 × ULN and if liver metastases, ALT and AST \<5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min
* normal cardiac function
* obtain informed consent

Exclusion Criteria:

* Patient still has standard treatment therapy based on NCCN guidance;
* Patient can not comply with research program requirements or follow-up;
* woman who are pregnant or breastfeeding;
* allergic to any drug in protocol or with contraindications;
* cannot understand or obey the protocol;
* with a history of allergies or intolerability;
* participate in other clinical trials meanwhile;
* any situations that hinder trial existed;
Biomarkers in Patients With Head and Neck Cancer and in Healthy Volunteers

RATIONALE: Studying samples of blood, tissue, and saliva in the laboratory from patients with cancer and from healthy volunteers may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This laboratory study is looking at biomarkers in patients with head and neck cancer and in healthy volunteers.

OBJECTIVES:

* Correlate the differences in serum protein profiles with the differences in the number of peptide matches in patients with squamous cell carcinoma of the head and neck and in healthy volunteers.
* Correlate protein levels with the largest difference in peptide matches in sera in these participants.

OUTLINE: This is a prospective study.

Participants undergo blood, tissue, and saliva collection for biological studies. Samples are analyzed for albumin-bound and non-albumin-bound proteins or IgG via liquid chromatography and tandem mass spectrometry (LC-MS-MS), ELISA, proteomic profiling, and protein expression.

PROJECTED ACCRUAL: A total of 50 patients and 50 healthy volunteers will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets one of the following criteria:

  * Diagnosis of squamous cell carcinoma of the head and neck
  * Healthy volunteer matched by sex, race, birth decade, or smoking status (e.g., current smoker, former smoker, or nonsmoker)

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Insulinotropic Effect of GIP and GLP-1 Before and After Reduced Glucose Tolerance

The incretin effect in patients with type two diabetes is reduced. The investigators have previously shown that it is possible to induce a defect in the incretin effect in healthy individuals. The purpose of this study is to evaluate the insulinotropic affect of the incretin hormones in healthy individuals before and after a deterioration of the glucose homeostasis.

The incretin effect in patients with type two diabetes is reduced. The investigators have previously shown that it is possible to induce a defect in the incretin effect in healthy individuals. The purpose of this study is to evaluate the insulinotropic affect of the incretin hormones in healthy individuals before and after a deterioration of the glucose homeostasis. The evaluation is done by infusing GIP, GLP-1 or saline during hyperglycemic clamps.

Eligibility Criteria:
Inclusion Criteria:

* Caucasians without type 2 diabetes mellitus
* Normal OGTT (75 g of glucose) according to WHO's criteria
* BMI 20-30
* Hemoglobin \> 8.0 mmol/l
* Informed consent

Exclusion Criteria:

* Liver disease (ALAT \> 2 x normal level)
* Nephropathy (s-creatinin \> 130 µM or albuminuria)
* Relatives (parents/siblings) with T2DM
* Medical treatment witch cannot be stopped for 12 hours
Multicenter Study Comparing Taxotere Plus Curcumin Versus Taxotere Plus Placebo Combination in First-line Treatment of Prostate Cancer Metastatic Castration Resistant (CURTAXEL)

Multicenter randomized phase II study, double-blind, comparing Taxotere plus curcumin versus Taxotere plus placebo combination in first-line treatment of prostate cancer metastatic castration resistant. Assess time to progression (time to progression) of metastatic disease (from first day of treatment in the trial).


Eligibility Criteria:
Inclusion Criteria:

* Patient older than 18 years.
* Performance status ≤ 2 according to the WHO criteria.
* Life expectancy\> 3 months.
* Patient in hormonal blockade based on surgical castration by orchiectomy or pulpectomy, medical or agonist or antagonists of LHRH associated or not with anti-androgens or any other treatment that blocks the fraction of non-gonadal testosterone, resulting in a testosterone \<0.5 ng / mL.
* Patient with adenocarcinoma of the prostate and histologically proven metastatic castration-resistant stage, defined by: objective progression of at least one measurable tumor target and / or assessable by RECIST, and / or increase in PSA ("rising PSA").
* Satisfactory biological functions (renal, hepatic and hematologic)
* Patient who signed the consent for participation before entering the study.
* Affiliation to a social security scheme (or be the beneficiary of such a plan) under the terms of the law of 9 August 2004.

Exclusion Criteria:

* Age \<18 years.
* Performance status\> 2 according to the WHO criteria.
* Patient deprived of liberty or under guardianship, patient with (the) condition (s) psychological, family, social or geographic may interfere with the proper conduct of the study.
* Diagnosis of a second malignancy in the past 5 years, with the exception of a basal cell skin cancer considered cured.
* Patient with brain metastases at initial assessment.
* Patient with another pathology deemed incompatible with the inclusion in the protocol.
* Laboratory tests inadequate.
* History of malabsorption syndrome or extensive resection of the upper digestive tract.
* Uncontrolled intercurrent infection.
* Pathology autoimmune and / or chronic active inflammation.
* peripheral neuropathy grade 2 according to the criteria of the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE, version 4.0).
* History of allergy to polysorbate 80.
* Treatment with nonsteroidal anti-inflammatory and / or cyclooxygenase-2 dated within three weeks.
* Concomitant with a drug test or participation in another clinical trial within \<30 days treatment.
* Regular Taking dietary supplements.
SPAD in Adult Patients

The DETECT study aims to demonstrate the importance of detecting SPAD in adult patients with recurrent benign and/or severe unexplained bacterial upper/lower respiratory tract infections. Unlike children in whom the deficit may be transient, long-term strategies are warranted in SPAD adult patients to prevent severe infections and lung disability. Beyond the diagnosis of this still unrecognized PID in adult patients, we want to assess the impact of prophylactic antibiotics or IgRT on infections prevention and on quality of life in adult patients with the most severe clinical phenotypes, recurrent infections with high frequency of antibiotics take and/or recurrent infections with complications like bronchiectasis and/or severe infections requiring hospitalizations.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 year old patients
* With a history of recurrent bacterial infections of upper and/or lower respiratory tract for at least 2 years, and fulfilling the specific following criteria:
* Recurrent benign infections currently requiring 6 courses of antibiotics /year or more, or Bilateral bronchiectasis/bronchiolitis (after exclusion of cystic fibrosis and ciliary dyskinesia) AND recurrent benign infections currently requiring 3 courses of antibiotics /year or more or A history of severe upper/lower respiratory tract bacterial infection, and/or invasive infection with Streptococcus pneumonia, Streptococcus pyogenes or Haemophilus influenzae, which required hospitalization in the last 2 years, AND recurrent benign infections currently requiring 3 courses of antibiotics /year.
* Normal serum IgG, IgA, IgM and IgG subclasses levels, normal CH50 and serum complement C3 and C4 proteins levels, normal T cells count
* Normal B cell count, normal serum protein electrophoresis and immunofixation. (\* excepted for Pseudomonas aeruginosa colonization)

Exclusion Criteria:

* Any general condition that predisposes to infections: solid or hematological malignancies, diabetes mellitus, severe alcohol or intravenous drug abuse, chronic liver or kidney failure, human immunodeficiency virus infection, anatomic or functional asplenia, drug-induced 1 neutropenia, or solid organ or hematopoietic stem cell transplantation;
* Any local predisposing factor to infections: cigarette smoking (\> 10 pack-year and/or 5 cigarettes/day), underlying infection (tuberculosis, influenza...), chronic obstructive pulmonary disease, oral, dental or skin conditions favorizing infections, streptococcal skin infections
* Any other SID or PID diagnosed before inclusion
* Pregnancy
* PPV23 administration in the last 2 years (risk of hyporesponsiveness)
The Use of Music in Reducing Pain During Outpatient Hysteroscopy

The aim of this study is to demonstrate the value of music in outpatient hysteroscopy on patients' level of pain and satisfaction. This may have a role in our daily practice in providing a better patient care in outpatient hysteroscopy.

Outpatient hysteroscopy is nowadays a commonly used procedure in Gynaecology in order to evaluate the uterine cavity and to diagnose different intrauterine diseases. It is a safe, convenient and cost-effective procedure in aiding the management of abnormal uterine bleeding. However, outpatient hysteroscopy can be associated with significant pain which would have impact on the woman's satisfaction and pain is one of the most common reasons for failure of the procedure.

Listening to music could be an easy and non-invasive way to reduce pain. A meta-analysis conducted on the effects of music on pain revealed that music interventions had statistically significant effects in decreasing pain on 0-10 pain scales. Researches on this topic in gynaecological office procedures, however, showed variation in the results. Some showed no positive effect of music on patient's level of pain, anxiety or satisfaction of patient or doctor for office hysteroscopy and colposcopy. On the other hand, some studies showed a positive effect of the use of music with a reduction of pain and anxiety during office hysteroscopy.

Eligibility Criteria:
Inclusion Criteria:

* indication for hysteroscopy (abnormal uterine bleeding, abnormal findings on ultrasound, and infertility)
* signed informed consent
* ability to read Chinese or English.

Exclusion Criteria:

* hearing impairment
* known anatomical abnormalities which would make performing the procedure more difficult
* use of premedication for cervical ripening
A Study to Assess the Safety and Efficacy of MUC1 Peptide Vaccine and hGM-CSF in Patients With MUC1-positive Tumor Malignancies

The scientific approach behind this study is to develop novel anti-cancer therapeutic vaccine to induce a robust cellular immune response mediated via both CD4+ and CD8+ T lymphocytes populations and can be be applicable to the majority of the target population.


Eligibility Criteria:
Inclusion Criteria:

1. All\* patients must have a histological or cytological diagnosis of metastatic disease or hematological malignancies expressing the MUC1. Patients must have metastatic disease, and have failed at least one regimen of standard based chemotherapy for metastatic disease as indicated in the following table. Patients must have disease considered to be incurable by surgical or radiological intervention.
2. Patients must be \> 18 years of age, consenting to participate in the study.
3. Patients must have at least one site of measurable tumor or measurable tumor marker.
4. Radiological and other relevant imaging studies, such as CT scans, must be performed within 4 weeks of the first treatment as a baseline to document extent of disease.
5. Patients should be at least 4 weeks beyond any major surgery or chemoradiotherapy and have recovered from drug induced toxicity.
6. Patients must have a performance status of 70% or greater on the Karnofsky scale (ECOG 0-2) and a minimal life expectancy of 12 months.
7. Patients must sign an informed consent, and be mentally responsible.

   * In Multiple Myeloma, MUC1 expression will be tested after confirming that all inclusion/exclusion criteria are met and within the screening period.

Exclusion Criteria:

1. Patients not fulfilling the above criteria.
2. Patients with a significant concurrent medical complication that in the judgment of the Principal Investigator could affect the patient's ability to tolerate or complete this study.
3. Patients receiving any immunosuppressive treatment that could negate development of an effective immune response to the vaccine. (First vaccination should be at least 30 days from end of immunosuppressive treatment)
4. Subjects with prior irradiation to a field that includes more than 25% of their lymph nodes and bone marrow likely to be immunosuppressed will be excluded. However, patients who had standard pelvic field radiation as adjuvant therapy for rectal cancer are not excluded.
5. Pregnant and breast feeding women will be excluded. Premenopausal women who are not practicing or willing to practice adequate birth control methods for a period of 3 months after treatment will be excluded.
6. Patients with brain metastasis.
7. Patients with active infection.
8. Patients with HIV HBSAg and HCV positive.
A Real-world Study in Participants With Smoldering Multiple Myeloma

The purpose of this study is to evaluate the real-world characteristics and outcomes of participants with smoldering multiple myeloma (SMM) overall and by high-risk and non-high-risk SMM according to (AQUILA study criteria \[NCT03301220\], Mayo 20-2-20 and international myeloma working group (IMWG) 2020 risk classification models), and to evaluate the risk of progressing of SMM to multiple myeloma (MM) and outcomes in participants after progressing to MM.


Eligibility Criteria:
Inclusion Criteria:

* Have a documented diagnosis of smoldering multiple myeloma (SMM). SMM is defined as: (a) Clonal bone marrow plasma cells (BMPCs) greater than or equal to (\>=) 10 percent (%) and/or serum M-protein \>= 3 grams per deciliter (g/dL) and/or urine M-protein \>= 500 milligram per 24 hours (mg/24hrs). (b) Absence of SLiM-CRAB criteria: \>= 60 % clonal BMPCs, involved/uninvolved free light chain (FLC) ratio \>= 100 and involved FLC \>= 10 and magnetic resonance imaging (MRI) lesions; calcium elevation, renal insufficiency, anemia, and bone lesions (AB) criteria
* Informed consent obtained prior to retrospective data collection in accordance with local requirements, either an informed consent form (ICF) indicating that the participants signed a consent for data collection for this research and agrees to have their data collected and analyzed, with source data verification (SDV), or the country does accept the ICF waiver for such type of studies
* Data recorded in participants' medical charts from date of SMM diagnosis and at least 2 years after should be available in the participant's medical chart at the participating site. However, participants who died within the 2 years from SMM diagnosis are eligible

Exclusion Criteria:

* Therapy for multiple myeloma (MM) initiated within 90 days of SMM diagnosis
* Date of SMM diagnosis is missing
* Participants who have participated/are participating in any SMM interventional (either active treatment or control arm) study are not eligible. Participation in observational studies is allowed. Participants who have participated/are participating in any MM study after evolution to MM are eligible
Sleep Quality and Pain Medication Use Following Arthroscopic Rotator Cuff Repair

The purpose of this study is to investigate if oral melatonin reduces postoperative sleep 18 disturbances and narcotics use. We will enroll patients undergoing primary arthroscopic rotator 19 cuff repair (ARCR) at the Rothman Institute.


Eligibility Criteria:
Inclusion Criteria:

* Patients who undergo primary ARCR
* Patient willing and able to complete postoperative surveys

Exclusion Criteria:

* Daily melatonin use for \> 1 week during the last 3 months
* Irreparable tears
* Revision rotator cuff repairs
* Severe glenohumeral arthritis
* Concurrent adhesive capsulitis
* Age less than 18
* Pregnancy
* History of substance abuse (drug or alcohol)
* Workman's comp patient or patient has current litigation pending
* Allergy to melatonin
* History of delirium/psychiatric/depression/ on antidepressants
* History of insomnia/ on sleep aid medication
* Use of prescription sedatives
* use of Zelboraf (vemurafenib)
* Use of all blood thinning medications besides aspirin (warfarin, plavix, lovenox, etc.)
* Sleep apnea
Effect of Health Diary on Self-management in Adolescent Patients With Fixed Orthodontic Appliance

This study aims to use two-arm randomized clinical trials to evaluate the effectiveness of the health diary in helping adolescents wearing fixed orthodontic appliances improve their oral hygiene status, self-management skills, oral health-related quality of life, self-efficacy, intention，number of breakages, and on-time and return visit status.


Eligibility Criteria:
Inclusion Criteria:

* Patients with malocclusion eligible for fixed appliance orthodontic treatment;
* The age of patients ranged from 12 to 18 years;
* The patients received orthodontic treatment for the first time;
* The patient was alert and had no cognitive or psychiatric impairment;
* The patient was able to read and fill out the questionnaires, and had good listening, speaking and understanding skills in Chinese.

Exclusion Criteria:

* The patient's disease was diagnosed as jaw deformity associated with other diseases. Malocclusion secondary to trauma, tumor, cleft lip and palate;
* Patients treated with orthodontic-orthognathic surgery;
* The patient currently participating in other oral related intervention studies.
Contraceptive Use and Respiratory Conditions Among Scottish Women

Studies examining the sex differences in the epidemiology and morbidity patterns of asthma show that the rates of disease severity, healthcare utilisation, and poor quality of life are considerably higher in women than in men, and this has been attributed to endogenous and exogenous sex hormonal factors. Studies examining the impact of use of hormonal contraceptives on the risk of asthma and asthma-related conditions are few, yet findings are conflicting.

In the present study, the investigators utilize data from the Scottish Health Survey, a national representative sample, to investigate the associations between current use of hormonal contraceptives and the prevalence of self-reported doctor-diagnosed current asthma and wheezing symptoms in Scottish women. The investigators hypothesize that while current use of any hormonal contraceptives and combined oral pills are associated with higher prevalence of asthma and asthma outcomes, current use of progesterone-only contraceptives is not associated with asthma. A secondary aim of the current study is to examine whether there is evidence of any biological interaction between use of hormonal contraceptives and BMI in relation to the risk of asthma and asthma outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Non-pregnant
* Woman
* 16-45 years old

Exclusion Criteria:

* Pregnant
* Man
* Younger than 16 years or older than 45 years old
Atrial Imaging and Cardiac Rhythm In Embolic Stroke

The ARIES study is an observational study in which patients with a recent acute ischemic stroke of cryptogenic aetiology are consecutively enrolled in order to perform a extensive cardiologic work-up. The main objective is to study parameters that could predict arrythmias on prolonged monitoring and also echocardiographic parameters of left atrial disfunction that could predict the presence of a hidden atrial fibrilation and recurrent ischemic events in patients with cryptogenic stroke.

Cerebrovascular diseases are the second most frequent cause of death in the general population, representing a 10% of global death. In order to prevent recurrent strokes, it is crucial to identify the underlying cause to administrate the best treatment in secondary prevention. Cryptogenic strokes are those in which the etiology remains unknown despite performing an extensive work-up; they represent between 20-62% of strokes. Occult atrial fibrilation is thought underlie up to 40% of cryptogenic strokes; it has also reciently been postulated that other left atrial arrythmias (parafibrilatory status) and left atrial markers of disfunction could represent a cardiac source of emboli.

Tha hypothesis of the ARIES study is that an extensive cardiologic work-up (advanced echocardiography measuring strain /stain rate and 3D echo and a 30 day continuos ECG monitoring) would detect atrial disfunction, parafibrilatory status and atrial fibrilation in patients with cryptogenic stroke, and that patients with these findings could have more stroke recurrences. This study is designed as a prospective observational unicentric study that includes patients with cryptogenic stroke in a consecutive matter in La Paz University Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Patients addmitted to the Neurology service at La Paz University Hospital with a recent diagnosis of cryptogenic stroke considered non-lacunar and where no other reasonable diagnosis is suspected.
* Signed informed consent.

Exclusion Criteria:

* Presence of large vessel atheromatosis with \>50% estenosis, or \<50% but with two or more vascular risk factors (age \> 50 years old, hipertension, diabetes mellitus, dyslipidemia, smoker).
* Patients with a un favorable clinical situation or dependance who will not benefit from the study or those that could not fullfill study visits and procedures.
* Patients in which an embolic arrythmia has already been demonstrated