cyrilzakka/clinical-trials huggingface dataset:
Real-world Clinical Outcomes of Patients With Early-stage Lung Cancer After the Surgery

The goal of this observational study is to evaluate the efficacy and long-term clinical outcomes of early-stage lung cancer patients who have received surgery using the real-world data. The main questions it aims to answer are:

* What is the best surgical strategy for patients with early-stage lung cancer?
* What are the risk factors for early-stage lung cancer? Participants will receive surgery and the study will analyze the real-world data.

This observational study aims to comprehensively evaluate the effectiveness and long-term clinical outcomes of surgical interventions in early-stage lung cancer patients, utilizing real-world data.

Central to this investigation are two key questions:

* What is the optimal surgical approach for managing early-stage lung cancer?
* What are the primary risk factors associated with the development of early-stage lung cancer? Participants will undergo surgical procedures, and through rigorous analysis of real-world data, this study endeavors to provide nuanced insights into these fundamental queries, fostering advancements in clinical decision-making and patient management strategies.

Eligibility Criteria:
Inclusion Criteria:

1. Aged between 18 and 85;
2. Did not receive neoadjuvant therapy before surgery;
3. No history of radiation therapy;
4. Eastern Cooperative Oncology Group (ECOG) score is 0-1;
5. Have complete clinically relevant information including imaging data;
6. All patients underwent relevant preoperative examinations;
7. Stage I lung cancer (International Association for the Study of Lung Cancer/The Union for International Cancer Control staging eighth edition);

Exclusion Criteria:

1. Have previously received chemotherapy, radiotherapy and other anti-tumor therapy;
2. Data loss and error in medical records due to human/objective reasons.
"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Narcolepsy"

This trial is a 12-week, randomized, double-blind, placebo controlled, multicenter, 4-treatment parallel group study of the safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with narcolepsy.


Eligibility Criteria:
Major Inclusion Criteria:

1. Males and females between 18 and 75 years of age, inclusive
2. Diagnosis of narcolepsy according to ICSD-3 or DSM-5 criteria
3. Body mass index from 18 to \<45 kg/m2
4. Consent to use a medically acceptable method of contraception
5. Willing and able to provide written informed consent

Major Exclusion Criteria:

1. Female subjects who are pregnant, nursing, or lactating
2. Moderate or severe sleep apnea on the baseline PSG.
3. Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness
4. History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
5. History or presence of any acutely unstable medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or surgical history that could affect the safety of the subject or interfere with study efficacy, safety, PK assessments, or the ability of the subject to complete the trial per the judgment of the Investigator
6. History of bariatric surgery within the past year or a history of any gastic bypass procedure
7. Presence or history of significant cardiovascular disease
8. Use of any over-the-counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness
9. Use of any medications that could affect the evaluation of cataplexy
10. Received an investigational drug in the past 30 days or five half-lives (whichever is longer)
11. Previous exposure to or participation in a previous clinical trial of JZP-110 (ADX-N05, R228060, YKP10A)
12. History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products
Stigma, Social Support and Quality of Life

The primary goal of this observational study is to investigate the relationship between perceived stigma and social support in HIV+ patients. The secondary objective is to measure mental health indicators (depression, anxiety, and stress) and quality of life to assess whether they are affected by the relationship between perceived stigma and social support.

The main questions it aims to answer are:

* Measuring perceived stigma and social support to understand the health status and behaviour of people living with HIV.
* Monitor the mental state of people living with HIV in order to be able to implement, there where necessary, a psychological support strategy in order to promote proper adherence to treatment and care services.

Participants will fill out an online cross-sectional survey. The online questionnairesurvey will collect:

* sociodemographic and clinical data related to HIV infection,
* perceived stigma,
* social support,
* mental health,
* quality of life.


Eligibility Criteria:
Inclusion Criteria:

* HIV diagnosis.
* Being treated at the Infectious Diseases Outpatient Clinic of Policlinico Gemelli in Rome.
* Ongoing antiretroviral therapy.
* Age \> 18 years.
* Native Italian speaker.
* Informed consent to participate in the study.

Exclusion Criteria:

* Absence of an HIV diagnosis.
* Not being treated at the Infectious Diseases Outpatient Clinic of Policlinico Gemelli in Rome.
* Absence of ongoing antiretroviral therapy.
* Age \> 18 years.
* Not being a native Italian speaker.
* Refusal to sign informed consent
Anti-mullerian Hormone (AMH) After Treatment of Endometriomas With Alcohol Sclerotherapy Versus Surgery: Clinical Trial

The purpose of this multicenter study is to compare the ovarian reserve after alcohol sclerosis of the endometriomas against conventional surgery (AMH, follicle stimulating hormone (FSH) and antral follicles count) as well as the complications and costs between the 2 procedures.

Clinical Trial Phase III, Multicenter, National, open, parallel-group assignment 1: 1, stratified by age, previous oophorectomy and uni- or bilateral ovarian involvement. Patients with suspected ovarian endometrioma by ultrasound will be randomized into 2 groups: (a) Study Group: echoguided aspiration plus sclerosis with alcohol; (B) Control group: Laparoscopic Cystectomy. Pre-treatment, and 6 months after treatment, AMH values will be determined. Complications, recurrences and costs from each treatment will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Uni- or bilocular endometrioma according ultrasounds
* Endometrioma size: 30-100 mm when symptoms were present and 50-100 mm if asymptomatics
* \> 3 months from diagnosis
* Ca125 \<200 IU/mL and human epididymis protein 4 (HE4) \< 70,

Exclusion Criteria:

* Previous gynecological cancer
* Symptomatic severe extraovarian endometriosis
* Dermoid or high risk of malignancy cysts
* Pregnancy
* Mental disability
Comparison of Two Diagnostic Tests in Patients With Suspected Invasive Candidiasis in Internal Medicine Wards and Who Are Currently Timely Treated With Micafungin

EPICA-1 is a multicenter, open label, interventional study which will involve about 30 Internal Medicine Units throughout Italy, enrolling globally at least 100 hospitalised patients with suspicion of invasive candidiasis. These patients will be treated with an echinocandin (micafungin) as timely as possible, and they will continue the antifungal treatment according to international guidelines when diagnosis is confirmed by positive 1,3-β-D-glucan test: this will allow collection of information on patients outcome. At the same time, patients will be also evaluated by means of blood culture, so that comparison will be possible between the two diagnostic tests (primary end-point of the study).


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years
* Patients giving their informed consent to participate to the study and to the use of their health data
* Patients with two or more SIRS criteria (hyperthermia, or hypothermia, tachycardia, tachypnea, leucocytosis or leukopenia )
* Patients treated with antibiotic therapy in the last 4 weeks and with central venous catheter
* Patients with at least one of these conditions ( cortisone therapy/ immunosuppressive agents, total parenteral nutrition, urinary catheter, anticancer chemotherapy and major surgery in the last 3 weeks, acute pancreatitis, diabetes mellitus, liver diseases, dialysis)

Exclusion Criteria:

* Patients with ALT, AST, bilirubin \> 3 times the upper limit of normal
* Patients enrolled in other interventional clinical studies
* Patients treated with echinocandin or azolic or polyene at the time of the enrolment
* Pregnancy or breastfeeding
* Neutropenic patients
* HIV positive patients
* Central nervous system events
Lengthening Temporalis Myoplasty and Improvement of Primary Swallowing Disorders in Facial Paralysis

The facial paralysis is a frequent disease causing important functionals swallowing dysfunctions. The purpose of our study was to evaluate the improvement of the swallowing disorders after surgery by lengthening temporalis myoplasty (LTM) in the facial paralysis.

This prospective study has realised on the following of patients affected by facial paralysis treated by LTM. Self-administered questionnaires and clinics tests had realized to analyze three components oh the oral phase of the swallowing ( drooling, mastication and handicap). The evaluations was realized before the surgery and at 3 and 6 months after .


Eligibility Criteria:
Inclusion Criteria:

* Chronic peripheral facial paralysis
* Freyss score inferior at 15
* Benefiting of a lengthening temporalis myoplasty

Exclusion Criteria:

* Malformative syndrome
* Other swallowing trouble
* Psychiatric trouble
* Opposed at this study
A Study to Evaluate the Effect of a Topical Retinol on Epigenetic Changes and Expression of Certain Genes in the Skin Using Non-invasive Measurements

This study is being conducted to confirm whether skin tape stripping methodology can identify changes in gene expression (i.e. whether different genes are turned on to make proteins) in aged skin after use of a retinoid.

This is a randomized study. Participants will be randomly assigned to either the intervention cell and receive a cleanser, a sunscreen serum, and a night cream or the control cell and receive a cleanser and a sunscreen serum to use at home for 10 weeks. Participants will be randomized and receive products at Visit 1 (Screening/Baseline) conducted at Day 0 and return to the clinical site at Day 28 for Visit 2, and at Day 71 for Visit 3.

Eligibility Criteria:
Inclusion Criteria:

1. Has clinically determined moderate photodamage (defined as a score of 4 - 6 on a 0- 9-point scale) on the face at Visit 1.
2. Is able to read, write, speak, and understand English.
3. Generally in good health.
4. Intends to complete the study and is willing and able to follow all study instructions

Exclusion Criteria:

1. Has known allergies or negative reactions to common topical skincare products, adhesives, latex, or ingredients in the study products.
2. Has clinically active bacterial, fungi, or viral skin infection or has frequent skin infections.
3. Presents with a skin condition that may increase risk to the subject, influence study results, or interfere with study evaluations (e.g. acne, psoriasis, eczema, atopic dermatitis, cutaneous xerosis, erythema, active skin cancer, tattoos, scarring, scratches/broken skin, sunburn, excessive hair growth, or very uneven skin tone) as determined by the principal investigator (PI).
4. Has self-perceived sensitive skin
5. Is a regular (occasional to daily) smoker of cigarettes or user of electronic cigarettes (vaping pens).
6. Is a regular (occasional or frequent) user of tanning beds and/or self-tanning products.
7. Has had a surgical or aesthetic procedure in the last 3 months that can affect facial wrinkles or facial pigmentation (e.g. botulinum toxin (Botox) injections, chemical peels, laser-based therapies to the face, or face lift surgery).
8. Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti- diabetic medication.
9. Is taking a medication that could mask a negative reaction or influence study results, as determined by the PI.
10. Is self-reported to be breastfeeding, pregnant or planning to become pregnant during the study.
11. Has a history of or a current health/other condition/situation which may put the individual at significant risk, influence the study results, or interfere significantly with the individual's participation in the study.
12. Is currently participating in any other clinical study or has participated in any product-use study within 30 days prior to the study visit.
13. Is an employee/contractor or immediate family member of the PI, study site, or Sponsor.
Contact Allergies to Dental Metal as a Possible Risk Factor for Oral Cancer

RATIONALE: Gathering information about allergies to metals may help doctors learn whether having an allergy to metal used in dental work increases the risk of developing oral cancer.

PURPOSE: This clinical trial is studying contact allergies to dental metal as a possible risk factor for oral cancer.

OBJECTIVES:

* Identify the relationship between intraoral metal contact allergy and epithelial carcinogenesis in patients with newly or previously diagnosed intraoral squamous cell carcinoma.
* Compare the prevalence of metal contact allergy in these patients with control data from other existing study populations.

OUTLINE: This is a multicenter study.

* Participants undergo metal patch testing using 27 metals\* commonly used in dental repairs that are part of the Mayo metal series. Metal patches are applied to the patient's back for 3 days and the back is read on days 3 and 5. Relevant patient data obtained from their medical and dental history, physical exam, laboratory values and treatment are documented.

NOTE: \*Healthy volunteers (control) undergo metal patch testing using 8 metals most commonly positive for contact allergens.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * Newly or previously diagnosed oral squamous cell carcinoma

    * Recruited from the otorhinolaryngology departments of Mayo Clinic Rochester and Mayo Clinic Arizona
  * Healthy volunteer (control)

    * No history of intraoral squamous cell carcinoma
    * Employed at Mayo Clinic Rochester or Mayo Clinic Arizona

PATIENT CHARACTERISTICS:

* No immunosuppression
* No other conditions that interfere with patch testing

PRIOR CONCURRENT THERAPY:

* Not specified
Reveal LINQ™ Heart Failure

The purpose of the LINQ™ HF study is to characterize Reveal LINQ™ derived data from patients with heart failure by assessing the relationship between changes in LINQ™ derived data and other physiologic parameters with subsequent acute decompensated heart failure (ADHF) events.

The study is a prospective, non-randomized, multi-center, observational, pre-market clinical study. The study is expected to be conducted at up to 30 centers in the United States. Up to 300 subjects will be enrolled to achieve approximately 40 heart failure events (no more than two per subject will contribute to the cumulative total). Study subjects will be followed for up to 3 years post-insertion or until official study closure defined as when Medtronic and/or regulatory requirements have been satisfied per the Clinical Investigation Plan and/or by a decision by Medtronic or regulatory authority, whichever occurs first. The expected study duration is approximately 4 years representing 1.5 years of enrollments and 2.5 years of follow-up.

The LINQ™ HF study is a Non-Significant Risk Investigational Device Exemption (IDE) study. The study is utilizing the Reveal LINQ™ device with an investigational LINQ™ HF RAMware download.

Eligibility Criteria:
Inclusion Criteria:

* Patient is 18 years of age or older
* Patient (or patient's legally authorized representative) is willing and able to provide written informed consent
* Patient is willing and able to comply with the protocol, including follow-up visits and CareLink transmissions
* Patient is NYHA Class III, per most recent assessment or at any time within 30 days prior to enrollment
* Patient had a HF event (HF event defined as meeting any one of the following three criteria):

  1. Admission with primary diagnosis of HF within the last 6 months, OR
  2. Intravenous HF therapy (e.g. IV diuretics/vasodilators) or ultrafiltration at any one of the following settings within the last 6 months:

     * Admission with secondary/tertiary diagnosis of HF
     * Emergency Department
     * Ambulance
     * Observation Unit
     * Urgent Care
     * HF/Cardiology Clinic
     * Patient's Home, OR
  3. Patient had the following BNP/NTpro-BNP within the last 3 months: If EF ≥ 50%, then BNP\> 200 pg/ml or NTpro-BNP \> 400 pg/ml OR If EF \<50%, then BNP\> 400 pg/ml or NTpro-BNP \> 800 pg/ml

Exclusion Criteria:

* Patient is pregnant (all females of child-bearing potential must have a negative pregnancy test within 1 week of enrollment)
* Patient is enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager
* Patient has severe valvular heart disease as defined by hemodynamically significant valve stenosis and/or prosthetic heart valve
* Patient has existing IPG, ICD, CRT-D or CRT-P device
* Patient has severe renal impairment (eGFR \<25mL/min)
Biventricular Versus Right Ventricular Pacing in Heart Failure Patients With Atrioventricular Block (BLOCK HF)

Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heartbeat, sometimes a pacemaker is used to control the rate and rhythm of the heartbeat. In this trial, the researchers will test if pacing both the left and right lower half of the heart (ventricles) will:

* decrease the number of hospital and clinic visits due to heart failure symptoms
* extend life
* delay heart failure symptoms as compared to those who are paced in only one ventricle (the right ventricle)


Eligibility Criteria:
Inclusion Criteria:

* Subject has standard class I or class IIa indication for pacemaker implantation in accordance with ACC/AHA/HRS guidelines
* Subjects diagnosed with atrioventricular (AV) block. An AV block is a disturbance when the heart's natural pacemaker sends a message from the atrium (top part of heart) to the ventricle (bottom part of heart) and the message is partially or totally blocked
* Subject is receiving first time implant
* Subjects with heart failure but no symptoms of it (New York Heart Association \[NYHA\] Class I), or subjects with mild heart failure that only sometimes interferes with their daily activities (NYHA Class II), or subjects with heart failure that severely limits daily activities (NYHA Class III)
* Subjects with documented reduced heart pumping function (left ventricular ejection fraction ≤ 50%) within past 90 days
* Subject is at least 18 years old
* Subject or authorized legal guardian or representative has signed and dated the Informed Consent
* Subject is able to receive a pectoral implant
* Subject is expected to remain available for follow-up visits at the study center
* Subject is willing and able to comply with the protocol

Exclusion Criteria:

* Subject has ever had a previous or has an existing device implant
* Subjects with some forms of chest pain or myocardial infarction (heart attack) within the past 30 days
* Subjects with coronary bypass within the past 30 days
* Subjects with stent within the past 30 days
* Subjects with valve repair or replacement within the past 6 months or is indicated for repair or replacement
* Subjects with a mechanical right heart valve
* Subject is indicated for a biventricular pacing device (CRT-P or CRT-D devices)
* Subject is enrolled in a concurrent study which may confound the results of this study (co-enrollment in any concurrent clinical study requires approval of the study manager)
* Subject is pregnant, or of child bearing potential and not on a reliable form of birth control
* Subjects with a previous heart transplant
* Subjects has been classified as NHYA Functional Class IV within prior 90 days (subjects with severe heart failure and should always be resting)
* Subject, legal guardian or authorized representative is unable or unwilling to cooperate or give written informed consent
Study of the Incidence of Cilioretinal Arteries in the Hungarian Population

The purpose of this study is to analyze the retinal arteries, to investigate the incidence, number, types, distribution and localization of cilioretinal arteries in the Hungarian Caucasian population.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian race
* Signed informed consent

Exclusion Criteria:

* Optical media opacities of the eye
TRUST-2: Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH)

This was an open-label extension of Study RIV-PH-402, TRUST-1: Treprostinil for Untreated Symptomatic Pulmonary Arterial Hypertension (PAH) Trial. Subjects who completed Study RIV-PH-402 were eligible to enroll.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who were enrolled in and completed Study RIV-PH-402 (TRUST-1)

Exclusion Criteria:

* Subjects who were unblinded for potential rescue therapy in Study RIV-PH-402 and were found to be allocated to the Remodulin treatment group were not eligible to participate in this study.
Repeat Antenatal Corticosteroids

This study will review records of women who broke their water early who received a repeat course of antenatal steroids.

Antenatal corticosteroids (ANCS) administered to a mother at risk of preterm delivery have been shown to decrease morbidity of prematurity if preterm birth occurs. Although early animal studies found that many repeated doses led to growth restriction a single repeat dose was found to benefit human neonates without a significant decrease in birth weight.

Current guidelines recommend two doses of ANCS administered 24 hours apart as a single "course." A repeat course of steroids is administered no less than 1-2 weeks after the first course if the mother remains at risk of preterm delivery. However, the main studies supporting the repeat course of ANCS excluded women with preterm premature rupture of membranes (PPROM). These authors designed exclusion criteria this way because of a theoretical increased risk of chorioamnionitis with administration of a glucocorticoid, which may have immunosuppressant effects. As a result, there is insufficient data to recommend a repeat dose of ANCS in women with PPROM.

One study and its follow up publication did include women with PPROM. It did not find an increased incidence of chorioamnionitis between the treatment and the placebo groups, although women with PPROM were not analyzed separately.

The combination of no increased incidence of chorioamnionitis but no clearly studied populations creates an opportunity for a randomized controlled trial of repeat doses of ANCS including only women with PPROM.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women with preterm premature rupture of membranes

Exclusion Criteria:

* Women who did not have preterm premature rupture of membranes