cyrilzakka/clinical-trials huggingface dataset:
Anxiety and Pain During Intervention for Abortion Under Local Anesthesia

The aim of the study is to retrospectively analyze pain and anxiety assessment data previously collected in routine care in women who had an abortion under local anesthesia in order to identify the predictive factors of pain and anxiety, as well as to compare the results with previously published data. The participants are women who underwent abortion under local anesthesia in the gynecology department of the Pitié Salpêtrière Hospital between May and October 2021.

Voluntary interruption of pregnancy corresponds to a social demand. The French National Authority for Health recommends that any woman wishing to have a surgical abortion should have the choice between general anesthesia and local anesthesia. The advantages of local anesthesia are its simplicity and safety; the disadvantages are that the state of consciousness during the procedure may be associated with anxiety, and the perception of persistent pain despite the local anesthesia.

The majority of patients express pain during the procedure. Anxiety may be a major predictor of pain during the procedure. Moreover, beyond its possible involvement in pain, anxiety is also a factor of patient discomfort in its own right.

The 10-point verbal numerical scale was used for assessing pain and anxiety. The State Trait Anxiety Inventory (STAI), a 20-item anxiety scale, is also used as a reference to measure anxiety. This scale is carried out for patients undergoing an abortion under local anesthesia in the department.

Other factors could have an impact on the level of pain : age, pregnancy term, parity, history of dysmenorrhea, history of domestic violence or sexual violence.

The investigator team conduct a retrospective analysis in a cohort of patients who underwent an abortion under local anaesthesia in the obstetrics gynecology department of La Pitié Salpêtrière, analyzing their level of pain before, during and after the intervention The secondary objective is to analyze their anxiety level. Age, term of pregnancy, parity, history of dysmenorrhea, history of violence will be analyzed as potential predictive factors of pain.

Eligibility Criteria:
Inclusion Criteria:

* patients who need an abortion under local anesthesia
* Women who speak and read French

Exclusion Criteria:

* NA
Assessing Financial Toxicity Using the PROFFIT Questionnaire in Patients Treated With Mini-invasive Approach for Urological Malignancies.

Patients previously treated with robotic surgery for urological cancers such as prostate, bladder and kidney cancer will be enrolled, in particular patients operated in the last twelve months will be included after signing the informed consent.

Within 12 months after mini-invasive procedure, subjects are identified, contacted by phone/email, or invited to attend during the regular scheduled follow-up visit. If this is not possible, patients will be asked to schedule a special interview to assess possible participation in the study. During follow-up or unscheduled visit, the subsequent information will be collected through a questionnaire that contains several socio-demographic and anamnestic questions.

During subsequent visit, PROFFIT and EORTC QLQ-C30 questionnaires will be administered to patients. Post-operative complications are reported using the Clavien-Dindo classification.

Anamnestic and socio-demographic information will be collected through a generic self-designed questionnaire including the following data: age, sex, residence (within or outside the Veneto region), marital status (married, divorced, cohabiting, single, widowed), employment status (employed, unemployed, retired), presence of dependents (yes/no), level of education (defined as primary, middle or high school, university degree), concomitant pathologies.

Additional data on the oncological history are also reported: histology and staging of the disease, presence or absence of metastatic disease, additional treatments before or after surgery (e.g. neoadjuvant treatments, adjuvant treatments, radiotherapy).

The rationale behind the design of this study is to define a snapshot of the impact of robotic surgery performed in uro-oncology patients on financial toxicity assessed through PROFFIT questionnaire. The design of a cross-sectional study allows to define whether minimally invasive surgical treatment can impact financial toxicity in a cohort of patients previously treated with minimally invasive surgery (which may differ for additional treatments received, ease of access to medical care secondary to place of residence/domicile, level of education, employment and family status).

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 years of age;
* ECOG PS 0-1
* Diagnosis of urological neoplasm (prostate, bladder and kidney cancer) treated with robotic surgery (robot-assisted prostatectomy, robot-assisted radical cystectomy, robot-assisted radical or partial nephrectomy) in the last twelve months;
* Subjects willing to sign informed consent.

Exclusion Criteria:

* Patients unable to fill out questionnaires (e.g., severe mental illness or cognitive dysfunction);
* Patients suffering from concomitant malignancies in other sites and in active treatment;
* Patients with a history of cancer not currently on active treatment may be enrolled.
Efficacy and Safety Study of 5 mg and 10 mg Rosuvastatin

The primary objective of the study is to compare the efficacy of Rosuvastatin 5 mg once daily with Rosuvastatin 10 mg once daily by assessment of the number of patients with hypercholesterolemia reaching the LDL-C target goal of \<100 mg/dL after 12 weeks of therapy.

This study will observe the followings:

1. To compare the effect of 5 mg/10 mg Rosuvastatin by assessment of the number of patients reaching LDL-C target goal after 24 weeks of therapy.
2. To compare the effect of 12 weeks therapy with 5 mg/10 mg Rosuvastatin on change in LDL-C (compare change from baseline).
3. To investigate the effect of 12 weeks therapy with 10 mg Rosuvastatin on change in LDL-C (compare values week 0 vs. week 12).
4. To investigate the safety of Rosuvastatin in regards to liver enzyme change, kidney function and muscle toxicity.
5. To compare the effect of 12 weeks therapy with 5 mg/10 mg Rosuvastatin on change in TC, HDL-C, TG, LDL-C density and HbA1c (compare change from baseline).
6. To investigate the effect of 12 weeks therapy with 10 mg Rosuvastatin on change in TC, HDL-C, TG, LDL-C density and HbA1c (compare values week 0 vs. week 12).
7. To investigate the effect of 12 weeks therapy on change in microalbuminuria in each treatment group (compare change from baseline).
8. To investigate the effect of 12 weeks therapy on change in BMI (compare change from baseline).

   The effects of the dose increase and the dose decrease from weeks 12 to 24 will be evaluated as follows:
9. To investigate the change in LDL-C by increasing the dose from 5 mg to 10 mg (compare values week 12 vs. 24).
10. To investigate the change in LDL-C by decreasing the dose from 10 mg to 5 mg (compare values week 12 vs. 24).
11. To investigate the change in TC, HDL-C, TG, LDL-C density and HbA1c by increasing the dose from 5 mg to 10 mg (compare values week 12 vs. 24).
12. To investigate the change in TC, HDL-C, TG, LDL-C density and HbA1c by decreasing the dose from 10 mg to 5 mg (compare values week 12 vs. 24).

Eligibility Criteria:
Inclusion Criteria:

* Age 45 - 75 years
* LDL - C between 130 mg/dL and 250 mg/dL
* TG \< 400 mg/dL
* HbA1c \< 7%
* Written informed consent to participate in the trial

Exclusion Criteria:

* Known hypersensitivity or history of SAE with another HMG-CoA reductase inhibitor, in particular any history of myopathy
* Active liver disease/severe hepatic impairment
* Treatment with cyclosporin or any disallowed drug
* Patients with unstable angina pectoris
Paclitaxel With Trastuzumab and Lapatinib in HER2-Positive Early Stage Breast Cancer

The purpose of this study is to study a new treatment for HER2-positive breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically confirmed adenocarcinoma with HER2/neu immunohistochemistry 3+ or FISH-amplified breast cancer with a ratio of ≥ 2.0
* Tumor size of ≤ 3 cm and node-negative disease. Nodes with single cells or tumor clusters \< 0.2 mm by H\&E or IHC are considered node-negative. Patients with micrometastasis (nodes with tumor clusters between 0.02 and 0.2 cm) are allowed. Further axillary dissection will be determined by the patient's surgeon as per standard of care.
* Patients must be ≥18 years of age.
* Patients must have an ECOG performance status of 0 or 1.
* Treatment should be started within 90 days of the final surgical procedure for breast cancer.
* Patients may have bilateral synchronous breast tumors. Patients may have received hormonal therapy for the purpose of chemoprevention but must be willing to discontinue prior to enrollment and while participating in this trial.
* If patients have peripheral neuropathy, it must be ≤ grade 1.
* Patients must be willing to discontinue sex hormonal therapy e.g., birth control pills, ovarian hormonal replacement therapy, etc., prior to enrollment. Women of childbearing potential must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter.
* Hematologic parameters: absolute neutrophil count (ANC) ≥1500/μL and platelet count ≥100,000/μL.
* Non-hematologic parameters: total bilirubin must be ≤ 1.5 X institutional upper limit of normal (ULN), transaminases (SGOT or SGPT) ≤ 3.0 x ULN.
* Negative HCG pregnancy test for premenopausal women of reproductive capacity and for women less than 12 months after the menopause. LVEF by ECHO (with strain if possible) with LVEF of ≥ 50%. If an ECHO cannot be done, a MUGA may be performed.
* Patients must give written, informed consent indicating their understanding of and willingness to participate in the study.

Exclusion Criteria:

* Patients with stage IV breast cancer or undergoing chemotherapy, radiation therapy, immunotherapy, or biotherapy for current breast cancer.
* Pregnant or breastfeeding patients.
* Patients with a concurrently active second malignancy, other than adequately treated non-melanoma skin cancers or in situ cervical cancer.
* Patients with unstable angina, congestive heart failure, or with a history of a myocardial infarction within 12 months. Patients with high-risk uncontrolled arrhythmias (ventricular tachycardia, high-grade AV block, supraventricular arrhythmias which are not adequately rate-controlled). Patients are excluded if they have grade 3 QT prolongation (Appendix F) (\>500 ms) or require drugs that may prolong the QT.
* Subjects who have current active hepatic (including hepatitis B or C) or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones).
* Patients with active, unresolved infections.
* Patients with a sensitivity to E. coli derived proteins.
RFA for Superficial Lipomas

Lipomas are non-cancerous growths of fatty tissue that develop under the skin in approximately 1 in 1000 people, though this number may be higher. While rarely symptomatic, they often cause emotional distress due to the unappealing appearance of the mass. Treatment of unsightly lipomas is excision with local anesthetic in the office or with sedation in the operating room. The recovery period is short and the procedure is low risk; however, the result of the operation is a visible scar over the site of the lipoma. Many patients defer surgical excision because excision of a lipoma is a cosmetic procedure, but the aesthetic outcome is undesirable.

Radiofrequency ablation (RFA) is a technique that applies heat generated by a high frequency, alternating current to soft tissue. The hyperthermia produced by the current causes tissue necrosis that ablates the tissue into which the energy is directed. RFA has been successfully applied to thyroid nodules, pancreatic lesions, esophageal dysplasia and liver tumors. However, the manufacturers of the RFA technology have been focused on its application in pre-malignant and malignant lesions and have not yet considered its application to benign tumors. This study will test the success of RFA for superficial lipomas as a non-surgical option for treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years old
* Patients with a lipoma \<5 cm, above the fascia on the trunk, abdomen or extremities

Exclusion Criteria:

* Lipomas of the face or neck
* Angiolipomas (identified on exam as a firm, mobile, occasionally discolored mass)
* Patients with history of hereditary retinoblastoma, Li-Fraumeni syndrome, familial adenomatous polyposis, neurofibromatosis, tuberous sclerosis and Werner syndrome
* A history of exposure to herbicides, arsenic and dioxin
* A history of radiation treatment for other cancers
Concurrent Involved-field Radiotherapy and Intrathecal Chemotherapy for Leptomeningeal Metastases From Solid Tumors

It has been proved that concurrent radiotherapy (RT) and intrathecal methotrexate (MTX) for leptomeningeal metastases (LM) from solid tumors with adverse prognostic factors showed great effectiveness and safety. Cytarabine(Ara-C) is another agent which is commonly used for intrathecal chemotherapy. The purpose of the study is to observe the effectiveness and safety of concurrent RT and intrathecal chemotherapy for LM from solid tumors. In addition, the effectiveness of these two types of agents (MTX and Ara-C) in the concurrent chemo-radiotherapy will be compared in this study. This is a randomized controlled, parallel group, and phase II clinical trial. The object of this study is newly diagnosis patients with leptomeningeal metastases from solid tumors, who will accept the treatment of involved-field RT combined with concurrent intrathecal-MTX or intrathecal-Ara-C, respectively. Major endpoint is clinical response rate. Secondary endpoints are time to progression,severe adverse events and overall survival.

The patients were randomly divided into two groups, who will accept the treatment of involved-field RT combined with concurrent intrathecal-MTX or intrathecal-Ara-C, respectively. Concomitant regimen consisted of intrathecal chemotherapy (via lumbar puncture, MTX 15 mg, plus dexamethasone 5 mg, or Ara-C 50mg, plus dexamethasone 5 mg, once per week, 4 weeks in total) and RT. RT consisted of fractionated, conformal radiation given at a daily dose of 2 Gy. The planning volume consisted of sites of symptomatic disease, bulky disease observed on MRI, including the whole brain and basis cranii received 40 Gy in 20 fractions and/or segment of spinal canal received 40-50 Gy. The RANO proposal for response criteria of LM disease was used to assess the clinical response in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who have been definitely diagnosed as leptomeningeal metastasis according to cerebrospinal fluid cytology or neuroimaging, or patients who got the clinical diagnosis by combining with the history of cancer, clinical manifestation, cerebrospinal fluid examination, neuroimaging etc;
2. Patients who have been diagnosed as malignant solid tumor with definite pathologic type, excluding hematological malignancies (e.g., leukemia and lymphoma) or primary brain tumors;
3. No severe abnormal liver and kidney function; WBC≥2500/mm3, Plt≥60000/mm3;
4. No other severe chronic diseases;
5. No history of severe nervous system disease;
6. No severe dyscrasia;
7. Signed informed consent form.

Exclusion Criteria:

1. Patients with leptomeningeal metastasis from unknown primary tumor;
2. Patients who had received radiotherapy to the brain in the past 6 months;
3. Patients who had accepted systemic chemotherapy within one month before the treatment, or molecular targeted therapy less than 3 months;
4. Patients with poor compliance, or for other reasons, the researchers considered unsuitable to participate in this clinical study.
Electrophysiological Effects of Irbesartan in Patients With Paroxysmal Atrial Fibrillation (AF)

The main purpose of the study is to compare the mean AERP between treatment groups based on the hypothesis that in subjects with paroxysmal AF, Irbesartan prevents electrophysiological remodeling resulting in a prolonged atrial effective refractory period relative (AERP) to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Recurrent PAF with indication for catheter ablation

Exclusion Criteria:

* Struct. Cardiopathy
* Mitral valve disease
* VEF\<40%
* Myocardiopathy
* LVH
* cardiac surgery
* AF reversible
* QT c\>450
* Recent MI/stroke, severe HTN
* Requirement of ACEI/ARBs
* Coronary synd., HTA, liver disease
Treatment With Sitagliptin in Non-obese Japanese Patients With Type 2 Diabetes Mellitus

Type 2 diabetes mellitus (T2DM) results from early phase insulin secretory defect and insulin resistance. Studies have shown that most of the populations in which insulin resistance is considered to be the primary pathogenetic cause of diabetes, have a higher degree of obesity than those of primary insulin defect. Meanwhile, defective early insulin secretion plays a predominant role in the non-obese subtype of T2DM which includes majority of Japanese patients.

Sitagliptin is a dipeptidyl peptidase-4 (DPP-IV) inhibitor as indicated for the treatment of T2DM. Sitagliptin increases plasma concentrations of active glucagon-like peptide-1 (GLP-1) and active glucose-dependent insulinotropic peptide (GIP) two- to three-fold in patients with T2DM. The effect of sitagliptin on GLP-1 results in lower fasting and postprandial glucose concentrations through increases in glucose dependent insulin release and suppression of inappropriate glucagon secretion. Namely, several mechanistic studies using standardized meal showed that sitagliptin improved glucose control with decreased glucagon levels and increased insulin concentration in obese or overweight T2DM patients with BMI \> 25 kg/m2. However, how sitagliptin affects islet function, including glucagon secretion in non-obese patients with low insulin secretion are not known. Therefore, the investigators will examine the effect of sitagliptin on glycemic control and the mechanism involved using a standardized test meal in non-obese Japanese patients with T2DM whose BMI levels are \< 25 kg/m2.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patients
* non-obese patients

Exclusion Criteria:

* patients treated with insulin therapy
* patients aged less than 20 years and more than 90 years
Controlled Study of the Effect of Xenaderm® Ointment Vehicle Versus White Petrolatum on Healing

The objective of the study is to compare the healing of wounds induced by cryo-injury when treated with white petrolatum versus an ointment vehicle.


Eligibility Criteria:
Inclusion Criteria:

Subjects will be considered qualified for enrollment if they:

* Provide written informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks and contact information.
* Are male or female, ≥ 18 years of age, of any race.
* Are willing to attend all required study visits, and to comply with study procedures.
* Meet none of the exclusion criteria (any single exclusion criterion which is met by a potential subject will disqualify that subject from participation in this study).

Exclusion Criteria:

Subjects will be considered NOT qualified for enrollment if they:

* Have a history of dermatomyositis, systemic sclerosis, scleroderma, Sjögren's syndrome, systemic lupus erythematosis, discoid lupus, Ehler's Danlos disease, icthyosis vulgaris, vasculitis or bleeding disorders (coagulopathies).
* Have any dermatologic disease which may be aggravated or provoked by the wounding procedure, such as Lichen Planus, Psoriasis or Vitiligo.
* Have Fitzpatrick scale skin type 6 (never sunburns, deeply pigmented).
* Are at risk of keloid or hypertrophic scar formation, based on personal history, family history, or brief skin exam (conducted at the screening visit to look for keloids or hypertrophic scars).
* Have been treated within the last three months for uncontrolled diabetes mellitus, peripheral vascular disease, vitamin C deficiency, connective tissue disorders, or any other disease process that impedes wound healing.
* Are taking concomitant medications at doses which are known to interfere with healing, such as non-steroidal anti-inflammatory drugs, anti-neoplastic drugs, or immunosuppressive drugs.
* Are using topical glycolic acid products, alpha-hydroxy acid products, retinoids or chemical peel agents in the treatment areas.
* Are using systemic steroids or immunosuppressant agents, or have used these drugs within the past three months.
The Effects of Vilazodone on Glutamate in the Anterior Cingulate Cortex in Anxious Unipolar Depressives

The purpose of this study is to determine whether vilazodone is more effective than citalopram for the treatment of anxious depression. We will use neuroimaging to see whether there are changes in the brains of patients receiving the drug vilazodone that are different from those of citalopram. These changes may show that vilazodone affects the brain differently than most other kinds of standard antidepressant medications.

This study proposes to utilize recent advances in magnetic resonance spectroscopy (MRS) techniques that permit reliable measurement of Glu in humans (9) to examine whether Vilazodone and citalopram exert differential effects on Glutamatergic neurotransmission in the ACC of anxious unipolar depressed patients. Functional connectivity as measured by Blood Oxygen Level Dependent (BOLD) MRI will be assessed to determine the relationship between the change in connectivity and the change in Glu levels with treatment. We also propose to examine, in an exploratory fashion, the relative effect of the two drugs on BOLD activation in the insula cortex.

Eligibility Criteria:
Inclusion Criteria:

* Female, aged 18-50 years.
* Meets DSM-IV criteria for unipolar major depression.
* MADRS score \> 20.
* Subject exhibits clinically significant anxiety and HAM-A score \> 15.
* Capable of providing informed consent.
* Has an established residence and phone.

Exclusion Criteria:

* A clinically significant medical condition which could impact the response of the individual to antidepressant treatment (e.g. diabetes, cancer, lupus or other autoimmune illness). Stably treated hypothyroidism (TSH \< 2) will be permitted.
* Beta blockers, antidepressants, antipsychotics, lithium, antiepileptic medications, steroids (oral and inhaled), chronic use of nonsteroidal antinflamatory medications (infrequent sporadic use permitted), or other medications with the potential to interfere with the antidepressant effects of Vilazodone.
* Pregnancy.
* In women of childbearing potential an unwillingness to use reliable methods to prevent pregnancy.
* History of manic or psychotic symptoms.
* History of seizure or epilepsy.
* History of alcohol or drug dependence and active use of substances in the past month.
* Active alcohol or drug abuse.
* Ingestion of 4 or more caffeinated beverages a day, on average.