cyrilzakka/clinical-trials huggingface dataset:
Study in Patients With Solid Tumor Regarding Access to Dermo-cosmetics and Aesthetic Solutions

Cancer treatments can trigger cutaneous side-effects, as well as nail and hair toxicities. When related to drug treatment, this iatrogeny depends on the type of drug, its dosage and individual susceptibility. Although these dermatological adverse events are rarely serious, they can significantly alter patients' quality of life, and may even necessitate the introduction of curative treatment.

The impact of these side effects can be mitigated by the use of dermo-cosmetic products and aesthetic solutions. However, most of this supportive care is not reimbursed by the health insurance system, representing a source of inequalities in access to healthcare for cancer patients.

This study aims at establishing, in a cohort of patients with solid tumors, the state of their knowledges, given information and their financial capacities regarding access to dermo-cosmetics and aesthetic solutions, that are used in the attenuation of cancer treatments' side-effects.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Patients with solid tumors (eligible localization include: digestive system, Head and Neck, Breast, Brain, Lung Tumors, Urological and Gynecologic cancers)
* Patients able to read and understand French
* Patients that has expressed their consent and with signed consent form

Exclusion Criteria:

* Minor or patients placed under guardianship or supervision
* Patients unable to read French
* Patients placed under judicial protection
Phase 2a Study of HPG1860 in Subjects With NASH

This is a Phase 2a, randomized, double-blind, placebo-controlled, parallel group, multiple arm, multicenter study of 3 different doses of HPG1860 versus placebo in subjects with biopsy-confirmed or phenotypic NASH.

This is a Phase 2a, randomized, double-blind, placebo-controlled, parallel group, multiple arm, multicenter study of 3 different doses of HPG1860 versus placebo in subjects with biopsy-confirmed or phenotypic NASH. Screening will occur up to 5 weeks prior to randomization; all eligible subjects will have baseline hepatic imaging during Screening, prior to randomization. Approximately 80 eligible subjects will be randomized 1:1:1:1 on Day 1/Week 0 (T1) to receive either HPG1860 3 mg (n = 20), or 5 mg (n = 20), or 8 mg (n = 20), or placebo (n = 20) for 12 weeks. Following a preplanned interim analysis, a dose cohort may be dropped and/or added.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of written informed consent prior to any study-specific procedure.
2. Males and females between 18 and 75 years of age
3. Nonpregnant, nonlactating women.
4. Male subjects must agree to utilize a highly effective method of contraception.
5. Body mass index (BMI) of ≥25 kg/m2 at Screening.
6. Non-cirrhotic NASH subjects.
7. NASH subjects with hepatic fat assessed by a central reader
8. Willing and able to adhere to study restrictions and agree to comply with study protocol.

Exclusion Criteria:

1. Pregnant or lactating females
2. Current significant alcohol consumption
3. Elevated LDL-C with stable dose of statin an or PCSK9 inhibitor
4. Renal dysfunction or nephritic syndrome or a history of nephritis
5. Recent infarction, unstable angina leading to hospitalization, uncontrolled, symptomatic cardiac arrhythmia
6. Uncontrolled hypertension
7. Type 1 diabetes or uncontrolled T2DM
8. Uncontrolled hypothyroidism
9. Liver transplant and/or other significant liver disease or dysfunction
10. HIV antibody positive
11. Known hypersensitivity or formulation excipient
12. Gastrointestinal conditions or procedures that may affect drug absorption
13. Hematologic or coagulation disorders
14. Unstable weight within the last 3 months
15. Active malignancy
16. Unexplained creatine kinase (CK) \>3 × ULN
17. Blood donation, blood transfusion
18. Unable to undergo or contraindication to MRI procedure
19. A medical or situational finding that in the investigator's opinion may compromise the subject's safety or ability to complete the study.
Estrogen Receptor Gene Mutations

We propose to analyze a DNA sample for mutations in the estrogen receptor gene from a patient who appears insensitive to estrogen hormone treatment.

We propose to analyze a DNA sample for mutations in the estrogen receptor gene from a patient who appears insensitive to estrogen hormone treatment.

Eligibility Criteria:
* INCLUSION CRITERIA:

Patient is individual with estrogen insensitivity.
Tracheobronchial Bioengineering Using Aortic Matrices for Airway Reconstruction

A technic of tracheal, carinal or bronchial transplantation using a stented cryopreserved aortic has been implemented by Pr E. Martinod in his thoracic surgery dept. The purpose of this study is to analyze the records of all the patients who have benefited from this treatment.

In the context of end-stage tracheobronchial disease (in particular tracheal or carinal indication) this technic propose a therapeutic alternative, in the context of bronchial replacement it allows to avoid pneumonectomy.

The advantages are to reduce mortality at 90 days, functional consequences and long-term complications.

In this observationnel study, data were collected prospectively in the medical records of all patients who have undergone a trachea or artificial bronchus transplant.

Eligibility Criteria:
Inclusion Criteria:Eligible patients were treated by human cryopreserved (-80°C) aortic allograft after undergoing a standard preoperative evaluation and cardiopulmonary tests. A multidisciplinary team approve d the treatment based on the following criteria: Patients (1) had proximal lung tumors requiring a surgical resection (pneumonectomy, carinal resection, or sleeve lobectomy) that may or may not have been treated with neoadjuvant chemotherapy and had adequate or compromised preoperative lung function tests; or (2) had significant major malignant or benign lesions of the trachea and bronchi untreated with conventional therapeutic approaches, and (3) have signed an informed consent form for this specific surgical intervention.

Exclusion Criteria:Patients were not treated by human cryopreserved (-80°C) aortic allograft if they :

(1) had a lung tumor requiring a standard lobectomy; (2) had nonresectable major locally invasive tumors; (3) had contralateral lymph node invasion; (4) had metastatic disease with the exception of a unique resectable brain metastasis; (5) had tracheal lesions requiring standard resection with direct anastomosis; (6) had an iodine allergy; or (7) received a preoperative evaluation indicating an inability to undergo a standard lobectomy.
Diffusion of Use of Low Molecular Weight Heparin for Thrombosis on the Medicine Services

The purpose of this research is to gain insight into the way in which physicians adopt new practice techniques. In particular, we are interested in how medical innovations diffuse throughout social networks. We wish to examine the diffusion of Low Molecular Weight Heparin (LMWH) use for Deep Vein Thrombosis (DVT) throughout the social network of general internal medicine interns, residents, and attendings at the University of Chicago Hospital. In numerous clinical trials, LMWH has been demonstrated to be as effective as unfractionated heparin as a bridge to long-term anticoagulation therapy with Coumadin, with the added benefit of early discharge from the hospital with easy dosing, no need for monitoring, and home therapy. A DVT critical pathway was established at the U of C in 1998, and LMWH was used off-label for that purpose beginning in 1997. However, it is unclear how quickly the use of LMWH was adopted by the physicians on the general medicine services, or whether there exists a pattern for this adoption.

The design of our study is retrospective in nature. We are interested primarily in the use of LMWH in patients admitted to the general medicine services between January 1, 1997 and February 1, 2001 with a primary and secondary diagnosis related to Venous Thromboembolism, including specific ICD-9 codes.

Using a data abstraction form, we gather the following information: 1) patient demographics, 2) identity of the attending, resident, and interns caring for the patient, 3) whether the patient had any absolute or relative contraindications for receiving LMWH, as delineated by the DVT critical pathway, including insurance status and 4)how the patient was treated for his/her condition. To examine whether the identity of the primary care physician affects whether LMWH is given, we also collect the name of the primary care physician if it is listed on the chart.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to General Medicine Services with a primary or secondary diagnosis related to venous thromboembolism

Exclusion Criteria:

* Non-General Medicine Services patients
CtDNA as a Novel Biomarker of Treatment Efficacy in Patients With Ovarian Cancer

This study is a prospective observational clinical trial. Patients who were diagnosed and treated for the first time were enrolled and their surgical pathology was confirmed to be high-grade serous ovarian cancer. At the same time, these patients will receive first-line maintenance treatment with PARP inhibitors after traditional chemotherapy. During the trial period, patients' plasma will be collected before surgery, after chemotherapy, during targeted maintenance therapy, and during disease progression, and ctDNA-specific genomes will be detected, and clinical data will be collected over the same period. It is expected that specific ctDNA can be used to predict the efficacy of PARP inhibitors in patients with ovarian cancer, and to detect the recurrence of the disease early.


Eligibility Criteria:
Inclusion Criteria:

1. Ovarian cancer first diagnosed and treated;
2. Pathologically confirmed as epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer;
3. The stage of the disease is II-IV, and surgery will be performed after evaluation;
4. Age ≥ 18 years old;
5. Subjects and their families fully understand the research plan and sign an informed consent form.

Exclusion Criteria:

1. Pathologically confirmed as non-epithelial ovarian cancer;
2. Surgical treatment cannot be performed after evaluation;
3. Malignant tumors found in other parts of the study were found within five years before enrollment or at the time of enrollment;
4. Patients who do not agree to use clinical first-line targeted drugs;
5. Severe mental illness;
6. Severe cardiovascular disease, uncontrollable infection, or other uncontrollable comorbid diseases.
CINtec PLUS Triage in HPV Primary Screening

Prospective study which will recruit participants when they attend for a routine cervical screening. The study will evaluate the use of CINtec PLUS for triage of human papillomavirus (HPV) positive participants in HPV primary screening.

The study will recruit participants (9800) prospectively by verbal invitation from the sample taker when they attend for their cervical screening test. Recruitment will take up to one year to complete. Participants in the study will undergo primary HPV testing. This will be followed by cervical cytology testing as per the normal National Health Service Cervical Screening Programme (NHSCSP) screening invitation pathway. Participants testing HPV negative will have reached their end point and will exit the study. Participants who test HPV positive will be triaged by cytology (the cytology screening result, available through the NHSCSP screen will be used). Participants with moderate or severe dyskaryosis (high-grade disease) will be immediately referred to colposcopy (as per NHSCSP guidelines) without further testing. Participants with borderline or mild dyskaryosis (low-grade findings) will undergo CINtec PLUS Cytology triage simulation; however, regardless of the CINtec PLUS result, all participants will also be referred to colposcopy as per NHSCSP guidelines. Participants with negative cytology will undergo CINtec PLUS Cytology triage and those testing positive (an indication of increased risk of CIN2+ \[high-grade disease\]) will be referred to colposcopy. Participants with negative cytology who also test CINtec PLUS negative will only be referred to colposcopy if they have tested positive for HPV16 or HPV18 as these 2 genotypes have been shown to confer an elevated risk for CIN2+ compared with the other HPV types. Participants with negative cytology who also test CINtec PLUS negative and have tested positive for non HPV16 and HPV18 types will undergo repeat HPV testing at 12 months as the low risk of CIN2+ associated with these participants does not justify immediate colposcopy referral and is unlikely to be granted ethical approval.

Clinical outcomes based on colposcopy and/or histology and/or cervical cytology will be recorded. All biopsies will have one slide stained with CINtec Histology (p16). The risk of CIN2+ will be evaluated for all participants in the study. Subsequently, clinical performance of CINtec PLUS Cytology will be evaluated.

This work will also include a cost analysis.

Eligibility Criteria:
Inclusion Criteria:

* Consenting women aged 25y-64y attending for cervical screening

Exclusion Criteria:

* Women aged \<25y and \>64y
Trivalent rHA Dose Escalation Study in Elderly Subjects

This study will compare the safety and immunogenicity of three different dose levels of an experimental recombinant influenza HA protein vaccine to a standard inactivated influenza vaccine in heallthy elderly subjects ages 65-80. Blood and nasal secretions for assessment of antibody responses will be obtained from all subjects prior to and one month after vaccination.

Approximately 400 healthy, ambulatory adults ages 65-80 will be randomized into one of four study groups to receive a single immunization of a licensed trivalent inactivated influenza vaccine or one of three dose levels of an investigatioanl trivalent recombinant influenza HA protein vaccine. The study will be conducted in 2 stages. In the first stage, 80 subjects will be randomized (20 per group) and receive one vaccination on Day 0. Safety will be evaluated after Stage 1 subjects have completed a 7 day follow-up. Enrollment of Stage 2 subjects will begin after the safety data for Stage 1 has been reviewed. In Stage 2, 320 subjects will be randomized (80 per group) and receive one vaccination on Day 0. Blood and nasal secretions will be collected prior to an approximately one month after vaccination to assess antibody responses.

Eligibility Criteria:
Inclusion Criteria:

* Medically stable adult age 65 -80.
* Able to give informed consent.
* Able to comply with all study procedures.
* Community dwelling.

Exclusion Criteria:

* History of immunodeficiency or treatment with immunosuppressive medications. (use of inhaled steroids or of topical steroids is not considered immunosuppressive).
* Allergy to eggs, egg proteins, thimerosal, or other vaccine components.
* Acute febrile illness or upper respiratory tract illness within 72 hours of vaccination.
* Life expectancy less than 6 months.
* Use of experimental vaccines or medications within one month of study entry.
* Receipt of parenteral immunoglobulin within one month of study entry.
* Any acute or chronic condition which in the opinion of the investigator would render vaccination unsafe or interfere with the evaluation of response.
The First-In-Man Pilot Study of Firehawk

This is a small-scale pilot clinical study of the Rapamycin-Eluting Coronary Stent System of Microport for the first time to assess the preliminary safety and feasibility used in the human body. And provide evidence for subsequent large-scale, multi-center, randomized controlled clinical trials, then provide the basis for the formal application of the product in China.


Eligibility Criteria:
Inclusion Criteria:

1. 18-75 years of age, males or non-pregnant females;
2. With silent ischemia evidence, patients with stable or unstable angina, or in patients with old myocardial infarction;
3. Total number of target lesion is 1;
4. Target lesion length ≤ 30mm (Visual); target lesion diameter between 2.25mm to 4.0mm;
5. Visual assessment of target lesion diameter stenosis ≥ 70%,TIMI blood flow≥1;
6. Each target lesion may be covered by a single stent;
7. Patients with indications for coronary artery bypass graft surgery;
8. To understand the purpose of testing, voluntary and informed consent, patients undergoing invasive imaging follow-up.

Exclusion Criteria:

1. Within 1 month of any acute myocardial infarction;
2. Chronic total occlusion (TIMI grade 0 flow before surgery), left main coronary artery disease, mouth lesions, multiple-vessel lesions, branch diameter ≥ 2.5mm bifurcation lesions and vascular lesions of the bridge;
3. Severe calcified lesions that cannot be successfully expanded and distorting lesions not suitable for stent delivery;
4. In-stent Restenosis lesions;
5. Intracoronary implantation of any branding stents within 1 year;
6. Severe congestive heart failure (NYHA class III and above) ,left ventricular ejection fraction or \<40% (ultrasound or left ventricular angiography);
7. Preoperative renal function serum creatinine \>2.0mg/DL;
8. Bleeding, active gastrointestinal ulcers, brain hemorrhage or subarachnoid hemorrhage and half year history of ischemic stroke, antiplatelet agents and would not allow an anticoagulant therapy contraindications patients undergoing antithrombotic therapy;
9. Aspirin, clopidogrel, heparin, contrast agent, poly lactic acid polymer and rapamycin allergies;
10. The patient's life expectancy is less than 12 months;
11. Top participated in other drug or medical device and does not meet the primary study endpoint in clinical trials time frame;
12. Researchers determine patient compliance is poor, unable to complete the study in accordance with the requirements;
13. Heart transplantation patients.
Study Evaluating Safety and Tolerability of Vabicaserin in Patients With Sudden Worsening of Schizophrenia

This study will evaluate the clinical safety and tolerability of vabicaserin in Japanese subjects that have a sudden worsening of their symptoms of schizophrenia. The study will also assess the efficacy of vabicaserin and compare it to risperidone.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects between \>=20 and =\<65 years of age
* Current diagnosis and DSM-IV-TR diagnosis of schizophrenia type (295.10, 295.30 and 295.90)
* Total PANSS score \>=70 and =\< 120

Exclusion Criteria:

* Subjects who are hospitalized against their will
* Current Axis I primary psychiatric diagnosis other than schizophrenia
* A score of 3 on CDSS question 8 which pertains to suicide
The Effect of Hormonal Add-Back Therapy in Adolescents Treated With a GnRH Agonist for Endometriosis: A Randomized Trial

The purpose of this study is to determine whether a regimen of norethindrone acetate + placebo or norethindrone acetate + conjugated estrogens is superior in maintaining skeletal health and quality of life in adolescents treated with a GnRH agonist for endometriosis.

Endometriosis has become increasingly recognized as a chronic illness which begins during adolescence. Untreated endometriosis may lead to chronic pain and infertility. As recognition of the need for prompt therapy increases, so does the length of time patients will be exposed to treatments. As a result, there exists a pressing need to evaluate adjunctive measures that may limit the associated negative health consequences of treatment.

A gonadotropin-releasing hormone (GnRH) agonist is one medication utilized for patients who have failed other treatments. While GnRH-agonists are effective in relieving symptoms, their long-term use is problematic. GnRH agonists induce a low-estrogen state, causing deleterious effects on bone mineralization. These negative consequences are especially important for our pediatric patients. Adolescence is the critical period in a woman's life for bone acquisition and attainment of peak bone mass. Anything that interferes with this process puts patients at risk for lifelong low bone density and future fracture.

"Add-back" therapy appears to be a promising adjunct to treatment for prevention of this bone loss. Daily therapy with low-doses of hormones preserves bone density in adult patients, without altering the efficacy of the GnRH-agonist. However, no data exist on the effect of add-back therapy in adolescents.

The aim of the current study is to evaluate the safety and efficacy of two add-back regimens, norethindrone acetate + placebo or norethindrone acetate + conjugated estrogens, for the preservation of skeletal health and quality of life in adolescents with endometriosis treated with a GnRH-agonist.

Eligibility Criteria:
Inclusion Criteria:

* Age 13-22 years, at least two years post-menarche
* Body mass index (BMI, kg/m2) between 18 -30 kg/m2
* Surgical diagnosis of endometriosis
* Clinical decision to treat with a GnRH agonist, leuprolide depot (Lupron Depot®; TAP Pharmaceuticals, Inc.) 11.25 mg intra-muscular every 3 months

Exclusion Criteria:

* Concomitant chronic diseases which affect bone health, such as cystic fibrosis, inflammatory bowel disease, renal disease, or diabetes mellitus
* Markedly impaired liver function or liver failure
* Personal history of thromboembolic event (such as deep venous thrombosis)
* Medication use known to affect bone metabolism:

  * Glucocorticoid therapy (including inhaled steroids) or anticonvulsants used in the last 6 months
The Incidence of the Intravascular Injection During S1 Transforaminal Epidural Steroid Injection in Two Approaches: Anteroposterior Versus Oblique

Lumbosacral transforaminal epidural steroid injection (TFESI) is helpful for the treatment of lumbosacral radicular pain, but in case of intravascular injection, infrequently serious complication can be developed. Against this backdrop, if there is any difference of frequency of intravascular injection incidence during S1 TFESI between method in anteroposterior view and method in oblique view using Scotty dog, the result can be crucial factor in selecting the approach. In addition, appropriate volume of injection will be checked in each approach.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (20-80 years of age) who were scheduled to receive S1 transforaminal epidural steroid injection for lumbosacral radicular pain at our pain management clinic

Exclusion Criteria:

* pregnancy
* coagulopathy
* systemic infection
* any active infection at the injection site
* history of allergy to contrast media, local anesthetics, corticosteroid
* patients unable to communicate or patients with cognitive dysfunction