cyrilzakka/clinical-trials huggingface dataset:
Oral Contraceptive Therapy and Sexuality

Oral contraceptives (OCs) ameliorate hyperandrogenism and regulate menstrual cycles. To reduce androgenic side effects of first- and second-generation progestins, several new progestins derived from progesterone or spironolactone have been developed in the last few decades. These progestins, such as drospirenone, cyproterone acetate and NOMAC, are designed to bind specifically to the progesterone receptor and to have no androgenic, estrogenic or glucocorticoid actions.

However, OCs with a more pronounced anti-androgenic effects are more likely to induce sexual dysfunction, mainly hypoactive sexual desire disorder, which can highly impact patient and partner's quality of life. Moreover, available data indicate that OC use might increase adiposity in adolescents and might be associated with central redistribution of body fat in young women with Polycystic ovary syndrome (PCOS) without a recognizable difference in clinical anthropometric measurements, including body mass index and waist circumference.

In this context, it would be worth to evaluate the effects of combined OCs on metabolic and sexual health (sexual desire, arousal, and other parameters of sexual health), body image and mood.

Primary study objective Evaluation, in a sample of female outpatient subjects, of the effect of oral contraceptives (OCs) on sexual function and distress, evaluated with the FSFI (Female Sexual Function Index) and FSDS (Female Sexual Distress Scale Revised) questionnaires and through clitoris artery hemodynamic parameters.

Secondary study objectives

Evaluation, in a sample of female outpatient subjects, of the effect of OCs on:

* body image perception, evaluated with the BUT (Body Uneasiness Test) questionnaire;
* mood and mental status, evaluated with the MHQ (Middlesex Hospital questionnaire);
* hormonal and metabolic parameters.

Exploratory Objectives: evaluation of the relationships between hormonal parameters, clinical scores and sexual function, body image, mood in the study population.

Eligibility Criteria:
Inclusion Criteria:

* Female subjects aged =/\> 18 years and of reproductive age.
* Capacity to give consent for study participation, after being adequately informed of the aims, benefits, risks, time and motion of the study.

Exclusion Criteria:

* Participation in another clinical trial.
* Known or suspected (or history of) malignancy or chronic illness.
* Serious organic or mental disease diagnosed by a psychiatrist (e.g., major depression currently treated with antidepressant medication) suspected on the basis of the medical history and/or clinical examination.
* Conditions that may affect the compliance to the study.
* Contraindications to therapy with the study drug or hypersensitivity to the study drug (active ingredient or excipients of the formulation).
Application of ROTEM Technology in Aortic Surgery

Comparison of the diagnostic capabilities of rotational thromboelastometry (ROTEM) and standard coagulogram in the detection of disorder and correction of the hemostasis system in the perioperative period in patients who underwent surgical intervention on the aorta under cardiopulmonary bypass and or circulatory arrest.

The patient is monitored in the intensive care unit according to the following scheme: ROTEM (NATEM, INTEM, EXTEM, FIBTEM; with high clotting time (CT) values in INTEM - HEPTEM is done) and a coagulogram (activated coagulation time (ACT), activated partial thromboplastin time (APTT), prothrombin time (PT), thrombin time (TT), fibrinogen, antithrombin III, platelet aggregation) are done on admission and after 6 hours - with a smooth course of the perioperative period. If it is necessary or the development of disorders in the form of bleeding or thrombosis that require correction, ROTEM and a coagulogram are done, treatment is carried out, and after elimination of the causes, ROTEM and a coagulogram are examined in dynamics to assess the effectiveness of the therapy.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 80 years.
* Patients after surgical interventions on the aorta with cardiopulmonary bypass and/or circulatory arrest (operations on the ascending aorta, aortic arch and thoracoabdominal aorta).

Exclusion Criteria:

* Patients with other cardiac surgery, including isolated endovascular interventions on the aorta.
Combination of AUY922 With Trastuzumab in HER2+ Advanced Breast Cancer Patients Previously Treated With Trastuzumab

The phase Ib part of the trial will assess the MTD of AUY922 in combination with Trastuzumab in patients with Trastuzumab-refractory locally advanced or metastatic HER2+. The MTD is defined as the highest drug dosage not causing in the first cycle of treatment (28 days) medically unacceptable dose limiting toxicity (DLT).

The phase II part of the trial will assess any potential effect on efficacy of adding AUY922 to Trastuzumab in patients with Trastuzumab-refractory locally advanced or metastatic HER2+ breast cancer.

Both AUY922 and Trastuzumab will be administered as a weekly IV infusion. Treatment should be continued as long as the patient does not have disease progression and tolerates the treatment. The following reasons are examples of acceptable reasons for discontinuing the study; tumor progression (by RECIST, as assessed by the investigator), unacceptable toxicity, death, or discontinuation from the study for any other reason, such as patient refusal, withdrawn consent, lost to follow-up or investigator decision.


Eligibility Criteria:
Inclusion Criteria:

* Female patients with confirmed HER-2 positive , non-operable locally advanced or metastatic breast cancer
* All patients must have received at least 1 but no more than 2 prior anti HER2 based regimens including at least 1 regimen containing Trastuzumab.
* All patients must have at least one measurable lesion as defined by RECIST criteria.
* All patients must have documented progressive disease following the last line of therapy before entering the study
* ECOG Performance status ≤ 1

Exclusion Criteria:

* Patients with known CNS metastasis which are: symptomatic or require treatment for symptom control and/or growing
* Prior treatment with any HSP90 or HDAC inhibitor
* Impaired cardiac function
* Acute or chronic liver or renal disease
* Patients who are currently receiving treatment with any medication which has a relative risk of prolonging the QTc interval or inducing Torsades de Pointes and cannot be switched or discontinued to an alternative drug prior to commencing AUY922
* Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention
* Patients who do not have either an archival tumor sample available or are unwilling to have a fresh tumor sample collected at baseline.

Other protocol-defined inclusion/exclusion criteria may apply
Effects of AffronEye®/ Crocuvis+® on Dry Eye Syndrome

Previous research has demonstrated the effectiveness of AFFRONEYE® / CROCUVIS+® dietary supplement, based on saffron extract, in the proper functioning of visual health, for example, against the development of glaucoma. The main objective of this study is to compare the results of clinical tests that evaluate signs and symptoms for the diagnosis of dry eye, between two groups (some that take the dietary supplement and others a placebo), in a sample of university workers and students who suffer from dry eye.


Eligibility Criteria:
Inclusion Criteria:

* Have dry eye according to the diagnostic criteria established by the Tear Film and Ocular Surface Society (TFOS) Dry Eye Workshop (DEWS).

Exclusion Criteria:

* Pathology of the anterior ocular surface under treatment (such as conjunctivitis, keratitis, among others).
* Take any type of dietary supplements, with or without botanical components in the last month.
* Pregnancy or breastfeeding (also excludes recent pregnancy within the last 3 months) and women planning to become pregnant.
Third Generation Cognitive Behavioural Therapy vs Treatment-as-usual for ADHD

The investigators hypothesize that the mindfulness Cognitive Behavioral Therapy program will lead to a reduction in attention deficit and hyperactivity disorder symptoms, anxiety and depression, and improve self-confidence, emotional control, social integration and school results.


Eligibility Criteria:
Inclusion Criteria:

* If deemed able, the patient must have given his/her informed and signed consent
* The parents (or legal guardian) of minor patients must have given their informed and signed consent.
* The patient and participating parents must be insured or beneficiary of a health insurance plan
* The patient is equal to or greater than 7 years old and less than or equal to 15 years old
* The patient presents with attention deficit and hyperactivity disorder with an ADHDRS-PI score \> 27
* The patient is currently not under treatment - OR - is treated with methylphenidate with a stable posology (not expected to vary in the near future) but remains symptomatic

Exclusion Criteria:

* The patient is participating in, or has participated in over the past three months, another trial or another study that may interfere with the results or conclusion of the present study
* The patient is in an exclusion period determined by a previous study
* The participating parent(s) is(are) under judicial protection, or is an adult under guardianship
* It is impossible to correctly inform the patient or his/her parent or legal guardian
* Patients or parents refusing participation, signature of the signed consent or follow-up procedures
* Previously documented mental retardation (IQ \< 70) or suspicion thereof by the investigator
* The patient has already participated in cognitive behavioural therapy (individual or group) in the six months preceding inclusion
* Patients diagnosed with autism spectrum disorder, psychotic disorder or bipolar disorder
* The family has participated in a parental guidance programme in the last 6 months.
* The family has already participated in the present study
The Effect of Xolair (Omalizumab) on Allergy Blood Cells

We are studying Xolair (omalizumab) to see it's effect on allergic blood cells. The blood tests will be done in a test tube to see if they react differently before and after treatment. The blood cells will be mixed with to whatever the person is allergic.

Must be allergic-asthma with IgE between 30 and 700 IU/ml.

Eligibility Criteria:
Inclusion Criteria:

* 2 year history of ragweed allergic rhinitis
* positive skin prick tests to ragweed \>5 mm wheal diameter
* serum IgE \<700 iU/m

Exclusion Criteria:

* Use of prohibited medications (e.g. antihistamine in past 7 days and topical or oral corticosteroids in past 1 month, beta-agonist or theophylline for 1 week
* History of immunotherapy in the past 2 years
* Exposure to Omalizumab in the past 2 years
* Clinically significant non-allergic or perennial rhinitis to avoid mediator release due to environmental allergens
* Asthma other than mild intermittent
* Women of childbearing potential who are not on an accepted form of birth control, as well as women who are breastfeeding
* Known sensitivity to study drug Xolair
* Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
* Patients with a previous history of cancer
* Use of any other investigational agent in the last 30 days
Study of CHOP + Campath for T-Cell, Null Cell, or Natural Killer (NK)-Cell Lymphoma

Primary Objective:

* To determine the toxicity profile and tolerability of alemtuzumab (Campath) when administered in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy (C-CHOP) in patients with T-cell, null-cell and NK-cell lymphomas.

Secondary Objectives:

* To evaluate response rate, overall survival, and disease-free survival in patients with T-cell, null-cell, and NK-cell lymphomas treated with Campath + CHOP chemotherapy.
* To assess the incidence of cytomegalovirus (CMV) reactivation in patients with these lymphomas treated with the Campath + CHOP combination.
* To determine features which might be predictive of resistance to treatment or predictive of relapse, including the absence of glycosylphosphatidylinositol (GPI)-linked proteins.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have a diagnosis of non-B-cell, non-Hodgkin's lymphoma (including T-cell, null-cell, or NK-cell lymphoma, but excluding lymphoblastic lymphoma)
* Stage II, III, or IV disease requiring chemotherapy
* At least one site of measurable disease, 1.5 cm in diameter or greater
* Age \> or = 18 years
* Absolute granulocyte count of at least 1500 cells/mm3, unless neutropenia is due to marrow infiltration by the tumor
* Platelet count of at least 100,000 cells/mm3 unless thrombocytopenia is due to marrow infiltration by tumor
* Creatinine less than 2 x upper limits of normal (ULN)
* Total bilirubin less than 2 x ULN (dose reduced vincristine and adriamycin required for bilirubin \> 1.2 mg/dL)
* Echocardiogram (Echo) or multiple gate acquisition scan (MUGA) documenting a normal ejection fraction prior to chemotherapy
* Able to give informed consent

Exclusion Criteria:

* Known central nervous system (CNS) involvement
* Known HIV disease
* Patients who are pregnant or nursing
* Any factor which might limit the patient's ability to provide informed consent
* Life expectancy \< 3 months
* Patients who are unwilling to agree to use an effective means of birth control while on treatment
CBD (Cannabidiol) Intraoral Application and TMD (Temporomandibular Disorders)

The aim of the project is to assess the effectiveness of reducing the masseter muscles tension and hyperactivity in patients with a painful form of TMD by using polymers containing CBD compared to placebo polymers.

Since the healing properties of CBD have been known for a long time, the assumption of the proposed research is to reduce the tension of the masseter muscles, reduce the bruxism index and occlusal strength, as well as reduce pain, from which patients with TMD suffer.

CBD intraoral application therapy seems promising in that field. Patients attending The Department of TMD in Zabrze, Polska will be randomly divided into two groups: experimental and placebo. sEMG activity values will be compared during 14 and 30 days therapy with polymers. the efficacy of the cannabis cream used in the study. Positive results will confirm the efficacy of CBD relaxing properties used in the study, compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

* Patient agreement to participate into the research study
* Age ≥18 and ≤ 60
* Good general health,
* Temporomandibular disorder-positive RDC/TMD examination for group Ia and Ib
* Presence of all teeth (with the exception of the third molars)

Exclusion Criteria:

* Cannabis cream/ placebo cream allergy
* Hypersensitivity to substances to be used in the study
* Wounds intra oral cavity
* Addiction to cannabis
* Patients being treated with analgesic drugs and/or drugs that affect muscle function
Correlative Biomarker Study in Patients With Myeloproliferative Disorders

Researchers will use abnormal blood and/or bone marrow cells, or materials derived from these abnormal cells, like DNA, RNA, protein or plasma, in laboratory studies. Toenail clippings will provide normal material like DNA for comparison with the abnormal material derived from the blood and/or bone marrow. The results of these studies will be correlated with subjects' disease symptoms and response to their experimental treatment. The MPD-RC researchers are interested in studying molecules from the blood and bone marrow, the exact molecules changing over time with the investigators choosing only the most promising for investigation.

The investigators are attempting to better understand the causes of MPD and to develop improved methods for the diagnosis and treatment of these diseases. These syndromes carry a high risk of developing leukemia. It is important to continue to learn more about these blood cancers and to learn more about the effectiveness and potential side effects of various treatments. It is believed that further basic knowledge about these cancer cells as well as the effects of treatment will lead to the improvement of current therapies and the development of entirely new treatments for these diseases. The MPD-RC is hoping to determine if a number of laboratory tests (biomarkers) will allow for the prediction of response in future patients to the treatment they would receive.


Eligibility Criteria:
Inclusion Criteria:

* Patients are to be registered to this study if they meet the eligibility criteria for one of the MPD-RC treatment protocols linked to this study.
* Patients diagnosed with the following Myeloproliferative disorders including: polycythemia vera (PV), idiopathic myelofibrosis (IM), and essential thrombocythemia (ET) who are participating in treatment protocols of the MPD-RC are eligible.
* Patients must have signed an informed consent to participate in a Myeloproliferative Disorders Research Consortium (MPD-RC) treatment study to which this protocol is a companion study. The subject must also have signed a consent to participate in this mandatory companion study.

Exclusion Criteria:

See inclusion criteria.
Eye Shields for Infants After Dilated Exam

The eyes of hospitalized infants are often assessed by dilated exam, and there is evidence that infants experience post-exam stress. Investigators will evaluate whether eye shields for infants after dilated eye exam lessen stress and discomfort.

Neonatal eye examinations are the standard of best practice in pediatrics. In the acute clinical setting, infants' eyes are inspected for eye development, defect, and disease. There is anecdotal and clinical evidence that infants experience stress after eye dilation. Investigators will evaluate whether eye shields for infants after dilated eye exam lessen stress and discomfort.

Eligibility Criteria:
Inclusion Criteria:

* Chronological age 0-12 months
* Infants who require dilated eye exams
* Parent or legal guardian consent/permission granted

Exclusion Criteria:

* More than a two-week interval between dilated eye exams
* Prior or ongoing medical treatment or therapy for the eye(s)
* Functional blindness diagnosed by eye exam
Study of XL820 in Adults With Solid Tumors

The purpose of this study is to assess the safety and tolerability of XL820 when given orally to adults with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Advanced solid tumor
* Cancer for which standard therapies do not exist or are no longer effective
* Life expectancy of \> 3 months
* Adequate bone marrow, liver, and kidney function
* Willing to use accepted method of contraception during the course of the study
* Negative pregnancy test (females)
* Written informed consent

Exclusion Criteria:

* Chemotherapy within 4-6 weeks of the start of treatment (depending on the therapy)
* Radiotherapy to more than 25% of bone marrow within 4 weeks of the start of treatment
* Investigational drug within 30 days of the start of treatment
* Subjects with known brain metastasis
* Uncontrolled medical disorder such as infection or cardiovascular disease
* Subjects known to be HIV positive
* Pregnant or breastfeeding women
Project EMPOWERING: Evidence-based PrEP for Justice-Involved Women and Their Risk Networks

This study has two components. The first component is designed to assess and compare the awareness, attitudes and clinical eligibility of Pre-exposure Prophylaxis (PrEP) in criminal justice (CJ) involved women. The second component is designed to evaluate the acceptability and feasibility of strategically delivering PrEP to CJ involved women and their risk network members.

Risk networks can be leveraged to maximally disseminate effective interventions to women, including PrEP, and thereby potentially avert some of the 50,000 annual incident HIV infections in the U.S. Few studies to date have capitalized on risk networks as a way to identify and engage high-risk individuals, like CJ-involved women, who could markedly benefit from PrEP. This study advances the field by: 1) Using an innovative network-based framework (a non-traditional model of care delivery) to engage a high risk population in PrEP dissemination as HIV prevention; 2) Incorporating a syndemic approach to PrEP that addresses HIV prevention in the context of substance use, psychiatric comorbidities, IPV, and stigma; and 3) Recruiting, enrolling, and retaining high risk networks of CJ-involved women who are difficult to reach by other means. In doing so, this proposal addresses key funding priorities of the Gilead Investigator Sponsored Research program, which includes research on PrEP implementation targeted to high risk populations and delivered in non-traditional clinical settings.

Eligibility Criteria:
Inclusion Criteria:

* Index participants reside in, or planning to reside in New Haven or Hartford, Connecticut,.
* Criminal justice-involved (anticipate release or have been released from prison or jail within 6 months, and/or are under or anticipating transfer to correctional community supervision (i.e. probation or parole)).
* Self-reported HIV negative.

Eligible and enrolled women will then recruit risk network members through respondent driven sampling, using vouchers.

Risk network members must:

* have a unique and valid referral coupon (from Index participant).
* Reside or planning to reside in New Haven or Hartford, Connecticut.
* Self-reported HIV negative
* 18 years of age or older

Exclusion Criteria:

* They are unable or unwilling to provide informed consent.
* Are threatening to staff.
Comparison of Laparoscopic Hill and Laparoscopic Nissen Anti-Reflux Procedures

The purpose of this study is to compare the effects (good and bad) of the Laparoscopic Hill anti-reflux procedure with the Laparoscopic Nissen anti-reflux surgical procedure to see whether one is better than the other.

The design is a two-armed prospective single-blinded comparison between the two procedures, performed and randomized independently at the Swedish Medical Center Cancer Institute in Seattle, WA, and at Legacy Health Systems in Portland, OR, in adult patients with uncomplicated gastroesophageal reflux failing medical management. A standardized operative technique for each procedures will be utilized at both institutions, and will include intraoperative manometrics and intraoperative photographic documentation of the gastroesophageal valve, as well as placement of clips at the GE junction to accurately identify its location post-operatively. To eliminate "expertise" bias, the investigator from each institution will participate in up to 50 of the first of each of the two procedures.

Eligibility Criteria:
Inclusion Criteria:

* abnormal levels of gastroesophageal reflux documented by pH monitoring who are failing medical management or are requiring maximal medical therapy for control
* \> 18 years of age and \< 75 years of age

Exclusion Criteria:

* hiatal hernias measuring \> 7 cm
* esophageal body amplitude \< 30 or in two or more segments
* \< 40% propagated peristaltic waves
* GE junction \> 5 cm above the esophageal hiatus
* dense fibrotic esophageal strictures which do not markedly improve with pre-operative medical therapy
* body mass index \> 40