cyrilzakka/clinical-trials huggingface dataset:
Safety Study of Pelvic and Prostatic SIB-IMRT With Long-term Androgen Deprivation for High Risk Localized Prostate Cancer

The purpose of this study is to evaluate the incidence of urinary and rectal acute side effects of a pelvic and prostatic intensity-modulated arctherapy with simultaneous integrated boost (SIB-IMRT)combined with long-term androgen deprivation for patients with high risk localized prostate cancer


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed adenocarcinoma of the prostate
2. High risk localized adenocarcinoma defined by at least one of the following criteria:

   * Clinical stage T2c, T3 or T4
   * Gleason score ≥ 8
   * Prostate-specific antigen (PSA)≥ 20 ng/ml and ≤ 100 ng/ml
3. Patient cN0, pN0 or Nx (negative lymphadenectomy or no lymphadenectomy)
4. No pelvic adenopathy ≥ 15 mm on CT or MRI,
5. Absence of bone and/or visceral metastasis
6. Androgen deprivation beginning no later than the day of radiotherapy and up to six months before irradiation
7. Absence of prior pelvic radiotherapy,
8. Absence of surgical treatment of prostate cancer except transurethral resection performed within 4 months minimum before radiotherapy,
9. Age ≥ 18 years and ≤ 85 years
10. ECOG performance status ≤ 1,
11. Estimated life expectancy \> 5 years
12. Membership of a social security system,
13. Signed informed consent.

Exclusion Criteria:

1. Prostate cancer histology other than adenocarcinoma,
2. pN1 patients (lymph node dissection after histologically proven)
3. PSA \> 100 ng/ml
4. History of cancer within 5 years prior to trial entry (with the exception of basal cell carcinoma skin)
5. Patient with severe hypertension uncontrolled by appropriate treatment (≥ 160 mm Hg systolic and / or ≥ 90 mm Hg diastolic)
6. Contra-indication for pelvic irradiation (eg scleroderma, chronic inflammatory disease of the digestive tract, etc ...)
7. Contra-indication to agonists or antagonists of LH-RH
8. Bilateral hip prosthesis,
9. Patients already included in another clinical trial with an experimental molecule,
10. Persons deprived of liberty or under guardianship
11. Unable to undergo medical test for geographical, social or psychological.
Quality of Life During Different Regimens of Combined Hormonal Contraceptives in Women of Reproductive Age

The aim of the present study is to investigate the psychosexual effects of combined hormonal contraception regimens, comparing them in terms of estrogen type and dosage, hormonal combination regimen and different routes of administration, in women seeking a hormonal contraception method to prevent unwanted pregnancies. In particular, the study focuses on the incidence of mood disorders and sexual dysfunctions associated with distress in the entire study population using combined hormonal contraception. It will also examine the incidence of these conditions under the influence of specific combined hormonal contraceptives, as well as whether different types of progestins and the route of administration (oral, vaginal or transdermal) may affect the occurrence of mood disorders and sexual dysfunctions.


Eligibility Criteria:
Inclusion Criteria:

* women of childbearing age (aged 18-40) who seek advice for use of combined hormonal contraception (CHC).
* stable relationship
Fructose Malabsorption in Northern Norway

Different published studies has shown a possible co-variation between leakage of fructose to the great bowel and exacerbation of irritable bowel syndrome (IBS) symptoms.

The aim of the FINN trial is to study the role of fructose malabsorption in patients with IBS in order to evaluate different diagnostic criteria for fructose malabsorption and at the same time study the effect of diet treatment in this cohort of patients and estimate the prevalence of fructose malabsorption.


Eligibility Criteria:
Inclusion Criteria:

* IBS patients satisfying ROME 2 diagnostic criteria

Exclusion Criteria:

* Seriously ill
* Organic abdominal disease
* Other functional bowel disease
The Effects of Orchiectomy and Age on Vascular and Metabolic Health in Older Versus Younger Transgender Women

This study plans to learn more about differences in heart disease risk after gender-affirming orchiectomy (i.e., testes removal) in older transgender (trans) women compared to younger trans women.

The global aim of this study is to characterize cardiometabolic risk (measured by vascular, metabolic and biochemical factors-which have not been extensively studied prospectively) in trans women before and after orchiectomy. Trans women appear to be at greater risk for cardiovascular disease (CVD) and blood clots compared to non-trans adults. The effect of orchiectomy on CVD risk among trans women is unknown, but orchiectomy may change blood vessel function and metabolic health. The investigators will examine blood vessel function and metabolic profiles of trans women before and at several timepoints after orchiectomy to identify age-related differences in CVD risk factors. This knowledge may lead to new approaches to prevent CVD in trans women as well as all people regardless of gender identity.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years and older
* Identify as a transgender woman
* Have taken estradiol and spironolactone for at least one year
* Currently taking oral or transdermal or injectable estradiol
* Have not yet undergone but desire orchiectomy

Exclusion Criteria:

* Under 18 years of age
* Don't identify as a transgender woman
* Not currently taking estradiol or spironolactone
* Have been on estradiol and spironolactone for less than one year
* History of orchiectomy
* Not deemed a candidate for orchiectomy
* Current tobacco smoker
* Current illicit drug use
* History of prior or active estrogen-dependent neoplasms
* Acute liver or gallbladder disease
* Venous thromboembolism
* Hypertriglyceridemia \>500 mg/dL
* Fasted plasma glucose \>7.0 mmol/L or previously treated diabetes
* Resting blood pressure \>140/90 mmHg
Therapeutic Massage for Generalized Anxiety Disorder

The purpose of this study is to compare the relative effectiveness of three relaxation treatments (therapeutic massage, thermotherapy, and time in a relaxing environment) in reducing anxiety in persons with Generalized Anxiety Disorder.

Anxiety and stress are costly problems that afflict millions of American adults. Together, they are among the most common reasons for which adults use complementary and alternative medical (CAM) therapies as well as more conventional relaxation therapies. Although massage is one of the most popular CAM treatments for anxiety, its effectiveness for this problem has never been rigorously evaluated. This study is designed to evaluate the effectiveness of massage as a treatment for a diagnosed anxiety disorder. Massage will be compared with two other relaxing treatments: thermotherapy and time in a relaxing environment, which reflect the types of activities that persons with anxiety might try to relieve their symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Member of Group Health, Seattle metropolitan area
* Generalized Anxiety Disorder confirmed by SCID
* At least moderate anxiety

Exclusion Criteria:

* Serious mental health co-morbidity
* Any life threatening condition
* Currently receiving psychotherapy
* Substantial alcohol use
* Contraindications for massage
A Study of the Safety and Pharmacokinetics of AGS-8M4 Given in Combination With Chemotherapy in Women With Ovarian Cancer

This is a parallel arm study to evaluate AGS-8M4 administered in combination with chemotherapy in subjects with ovarian cancer. AGS-8M4 will be administered as an IV infusion until disease worsens.

All Subjects will receive AGS-8M4 treatment. Subjects will be enrolled into 1 of 2 treatment arms according to their disease status. A disease assessment will be performed every 8 or 9 weeks (± 3 days) depending on the treatment arm assignment. The assessment will be based both on changes in clinical symptoms, and radiographic images. Subjects without evidence of disease progression may continue to receive treatment based on their original treatment assignment until disease progression or intolerability. A safety follow-up visit will occur 4 weeks after the last dose infusion of AGS-8M4.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with recurrent disease Stage III/IV diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma
* Subjects with either platinum resistant or platinum sensitive ovarian cancer
* At least 14 days of previous cytotoxic chemotherapy and have recovered from all toxicities
* Left ventricular ejection fraction (LVEF) equal to or greater than the institutional lower limit of normal as measured by echocardiogram or MUGA (ONLY required for platinum resistant patients)

Exclusion Criteria:

* Active infection requiring treatment with systemic (intravenous or oral) anti-infectives (antibiotic, antifungal, or antiviral agent) within 72 hours of screening
* Use of any investigational drug within 30 days prior to screening
* Prior monoclonal antibody therapy other than Avastin
* Avastin administration within 90 days of screening
* History of thromboembolic events and bleeding disorders ≤ 3 months (e.g.,DVT or PE)
The Usability and Injection Time of the Physiolis Syringe and Autoinjector in Rheumatoid Arthritis Patients

This was an open-label, Phase 2 study designed to obtain user experience data (Phase A) and injection time data (Phase B) in experienced adalimumab patients injected with the Physiolis pre-filled syringe and autoinjector used to administer adalimumab.

This was a Phase 2, open-label study consisting of 2 study phases with a total of 3 study visits, each visit occurring 2 weeks apart from each other. Phase A (User Experience) was a randomized, 2-period, cross-over phase in which single subcutaneous (SC) dose injections were administered using either the Physiolis autoinjector and current autoinjector or the Physiolis syringe and current syringe in a 1:1 ratio. Phase B (Injection Time) was a randomized, single-visit, parallel-arm phase, with injection into a test tube, and one SC injection given to participants using the Physiolis autoinjector or current autoinjector administered at 2 different temperature ranges (2° to 8°C \[storage temperature\] and 20° to 27°C \[room temperature\]). If a participant only completed Visit 1 and Visit 2, then the participant was to be replaced for Visit 3. If the participant only completed Visit 1, the participant was to be replaced for all study visits.

Eligibility Criteria:
Inclusion Criteria:

* Subject was judged to be in good health as determined by the investigator based upon the results of medical history, laboratory profile, physical examination, chest x-ray, and a 12-lead electrocardiogram performed during Screening.
* Subject had a negative purified protein derivative (PPD) test (or equivalent) and chest x-ray (posterior-anterior and lateral view) at Screening.
* Subject has a diagnosis of moderate to severe rheumatoid arthritis and is treated with adalimumab in accordance with the FDA-approved Humira prescribing information.
* Subject must have self-administered adalimumab subcutaneous (SC) 40 mg injections every other week (eow) without interruption for at least 3 months prior to Screening.
* For the Phase A portion of the study, the subject must be able and willing to self administer SC injections in the thigh or abdomen (administration by another person was not permissible).

Exclusion Criteria:

* Subject has been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) of the drug prior to the Visit 1, with the exception of adalimumab.
* Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to the Visit 1 or oral anti-infectives within 14 days prior to Visit 1.
* Prior exposure to natalizumab (Tysabri®) or efalizumab (Raptiva®).
* Known hypersensitivity to adalimumab or its excipients.
* Regular use of any SC medications, with the exception of adalimumab.
The CO2RE® System for Vulvar Lichen Sclerosus

Subjects with vulvar lichen sclerosus (VLS) will undergo fractional carbon dioxide (CO2) laser treatment to the vulvar area. Subjects will be evaluated for changes in clinical signs and architectural changes associated with VLS at designated follow-ups to 1-year post treatment series.

This study is a prospective, non-randomized, single-group assignment, interventional clinical trial. Female subjects with vulvar lichen sclerosus (VLS) supported by histologic findings on biopsy and/or clinical signs on physical examination and recalcitrant to mid- to high-potency steroid therapy, will undergo up to 5 monthly treatments to the vulva with a fractional CO2 laser.

Investigators will assess clinical signs and architectural changes associated with VLS. Baseline measurements will be compared to follow-up at 6 weeks, 3 months, 6 months and 12 months after the final treatment.

Subjects will self report sexual function using a validated FSFI Questionnaire at baseline and at the 3- and 6-month follow-ups.

Eligibility Criteria:
Inclusion Criteria:

1. Able to read, understand and sign informed consent for study participation;
2. Female subjects with age 18-80 years;
3. Biopsy demonstrates biopsy-proven lichen sclerosus and/or there are characteristic changes for vulvar lichen sclerosus on physical examination;
4. Treatment of LS has been recalcitrant to mid to high-potent topical corticosteroid treatment or subject refuses topical corticosteroid treatment. Recalcitrance to therapy is defined as no response to topical corticosteroids of an adequate potency (i.e. clobetasol propionate 0.05% ointment or other steroids) and a sufficient duration (12 weeks of use) or lack of symptomatic control of the disease with a maintenance therapy;
5. Topical corticosteroid treatment, if any, will be continued during the study period;
6. Exogenous hormone treatment, if any, will be continued during the study period (type and dose must stay consistent throughout the study);
7. One or more of the following symptoms: itch; pain unrelated to intercourse; pain, skin tearing or bleeding with intercourse; changes/decrease in sexual function;
8. No breaks, tears or lesions, malodorous discharge or strawberry cervix present on gynecological exam.

Exclusion Criteria:

1. Presence of clinically atypical appearing nevi in the area to be treated;
2. Unexplained vaginal bleeding;
3. Active infection, specifically: urinary tract infection, vulvar or vaginal infection (candidiasis, genital herpes/herpes simplex virus, bacterial vaginosis, trichomonas);
4. History of vulvar or any gynecological malignancy, as well as history of pelvic radiation therapy or stem cell transplant;
5. Pelvic organ prolapse \> stage 2;
6. Pregnancy or planning pregnancy during the study;
7. Systemic treatment with immuno-modulatory drugs.
8. Use of vaginal dilators during study.
Detection and Characterization of Pulmonary Disease by Transthoracic Doppler (TTD)

The study seeks to characterize data obtained from patients with a variety of lung diseases using ultrasound Doppler signals obtained from lung tissue. A standard ultrasound device in a Doppler mode is placed on the chest wall and the unique software the investigators have developed analyzes the signals reflected from within the lung. On the basis of of pilot studies performed previously the investigators expect to receive different signals from different diseases that will enable diagnosis of different lung diseases.


Eligibility Criteria:
Inclusion Criteria:

* Able and willing to provide informed consent
* Age 18 years or older
* Clinic and hospital records including additional background medical data such as results of echocardiograms, cardiac catheterization pathology reports etc., available and accessible.
* Evaluation by a physician who determines that a High Resolution Computed Tomography (HRCT) of the Thorax and pulmonary function tests, including spirometry, lung volumes and diffusion capacity, are indicated as part of the standard clinical care.
* If full lung function tests are normal imaging with a regular chest x-ray is sufficient.

  * Study Population - subjects will be grouped based on the following criteria after obtaining pulmonary function tests and HRCT of the thorax -

    1. COPD based on clinical assessment and spirometry showing airflow limitation i.e., (FEV1/FVC \< 0.70).
    2. Interstitial lung disease (ILD) diagnosed by HRCT.
    3. Control subjects presenting with pulmonary complaints evaluated by full PFTs (spirometry, lung volume and DLCO) and a chest x-ray and/or HRCT , all found to be within normal limits, .

       Exclusion Criteria:
  * Primary or metastatic lung cancer.
  * Acute pneumonia.
  * Concomitant or previous diagnosis of Bronchial Asthma.
  * Patients with severe chest wall deformity
  * Decompensated heart failure or volume overload.
  * Significant right-sided pleural effusion.
Trial of Afatinib in Pediatric Tumours

Open-label, dose escalation, monotherapy, basket trial with biomarker specific MTD expansion cohort/Phase II part.

The trial will consist of 2 parts:

1. Dose finding part to determine the MTD
2. Biomarker specific MTD expansion cohort/Phase II part to assess clinical anti-tumour activity in included tumour types


Eligibility Criteria:
Inclusion criteria:

* Paediatric patients aged 1 year to \<18 years at the time of informed consent
* diagnosis of HGG, DIPG, low grade astrocytoma, medulloblastoma/PNET, ependymoma, neuroblastoma, RMS and tumours with ErbB deregulation
* recurrent/refractory disease after they received at least one prior standard treatment regimen
* no effective conventional therapy exists
* Performance status \>= 50% (Lansky for =\<12ys; Karnofsky for \>12ys)
* Further inclusion criteria apply

Exclusion criteria:

* relevant toxicity from previous treatment
* known pre-existing relevant cardiac , hepatic, renal, bone marrow dysfunction, ILD, keratitis
* Further exclusion criteria apply
The Relation Between Plasma Irisin Level and Endothelial Dysfunction in Type 2 Diabetes

Irisin is a signaling protein that is released into the blood from skeletal muscle after proteolysis of the membrane protein FNDC5 . FNDC5, encoded by the Fndc5 gene. Irisin activity on subcutaneous white adipose tissue, both in culture and in vivo, stimulated UCP1 expression and induction of brown adipocytes in white adipose tissue depots, a process known as white fat ''browning''. Irisin increases total energy expenditure in animal models, and irisin expression in mice fed a high fat diet resulted in a significant improvement in glucose tolerance and a reduction in fasting insulin levels. Collectively, these data suggest that decreased serum irisin levels may be associated with the development of insulin resistance and Type 2 diabetes. Indeed, some studies showed that irisin levels were decreased in newly diagnosed Type 2 diabetes.

Endothelial dysfunction is an early physiological event in atherosclerosis. However, to date, no data are available on the relationship between circulating irisin and endothelial dysfunction in diabetes. Therefore, the investigators hypothesized that circulating irisin level is associated with endothelial dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed type 2 diabetic patients
* aged 40～70 years

Exclusion Criteria:

* Patients with hypertension and those with micro- and macroangiopathy, including nephropathy \[urinary albumin excretion rate (UAER) \> 20 μg/min\], retinopathy (at least one microaneurysm or hemorrhage or exudates in either eye), neuropathy (pain in extremities, paresthesias, and absent tendon reﬂexes and/or absent vibration sense), coronary artery disease (myocardial infarction, ischemia electrocardiogram changes, and angina), cerebrovascular disease (transient ischemic attack or stroke), and peripheral vascular disease (the abolition of one or more peripheral arterial pulse and/or intermittent claudication and/or a past history of revascularization of the lower limbs) were excluded from the study.
PD-1 Inhibitor and Nab-paclitaxel and Bevacizumab in CUP

This trial is a single-center, prospective, single-arm Phase II clinical study. The purpose is to evaluate the efficacy and safety of recombinant humanized anti-PD-1 monoclonal antibody combined with albumin paclitaxel and bevacizumab in the second-line treatment of patients with unknown primary tumors.

Recombinant humanized anti-PD-1 monoclonal antibody combined with albumin paclitaxel and bevacizumab treatment, once every 3 weeks, treatment until disease progression, intolerable adverse reactions, patient death or withdrawal informed agree.After treatment, the patients was followed up every 9 weeks for follow-up treatment and survival.

Eligibility Criteria:
Inclusion Criteria:

1. The histopathologically confirmed metastasis is adenocarcinoma, squamous cell carcinoma, poorly differentiated carcinoma, poorly differentiated malignant tumor or neuroendocrine carcinoma;
2. Patients whose primary lesions cannot be found after standard evaluation prior to treatment: detailed history, physical examination, blood test, chest and pelvic CT, PET/CT (optional), endoscopy of symptomatic sites, and pathological examination;
3. Measurable lesions (RECIST 1.1 criteria);
4. Patients who have progressed after receiving first-line treatment for Carcinoma of Unknown Primary. For example, those who have received paclitaxel or docetaxel in the first-line treatment and progressed more than three months after the end of last treatment;
5. ECOG of 0-2;
6. Life expectancy\>3 months;
7. Within 7 days (including 7 days) before screening, the laboratory test data requirements: neutrophil count ≥1.5×10\^9/L, platelet count ≥90×10\^9/L, hemoglobin ≥90g/L (No blood transfusion in 14 days), serum total bilirubin ≤1.25 times the upper limit of normal (ULN); ALT and AST≤2.5 x ULN (patients with liver metastases ≤5x ULN); serum creatinine ≤1.25 x ULN

Exclusion Criteria:

1. Patients who have previously been treated with albumin paclitaxel or bevacizumab or PD-1 monoclonal antibody;
2. Received any experimental drugs or anti-tumor drugs within 4 weeks prior to enrollment;
3. A history of other tumors in the past 5 years, except for cervix or basal cell carcinoma of the skin that has been cured;
4. Symptomatic brain or meningeal metastases (unless the patient receives treatment for\> 6 months, the imaging results are negative within 4 weeks before entering the study, and the clinical symptoms related to the tumor are stable at the time of entering the study).

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Efficacy of Honan Balloon in Intraocular Pressure Reduction Before Phacoemulsification

-Does Honan balloon reduce intraocular pressure preoperatively?

-Does Honan balloon improve surgeon's satisfaction and patients' pain score when compared to no honan group?

Eligibility Criteria:
Inclusion Criteria:

* cataract patient,who plan to undergo phacoemulsification
* no previous ocular surgery

Exclusion Criteria:

* one eye
* high myopia
* Use ASA or anticoagulants
* History of glaucoma or ocular hypertension
* uncooperative patients
Long Term Effects of Awake Prone Positioning in COVID-19 ICU Patients

Long term follow up of patients included in a randomized controlled trial evaluating awake prone positioning among patients suffering SARS-CoV2 pneumonia (NCT04358939)

All patients included in the initial trial who survived and were not lost to follow up at 28 days will be invited for a telephone interview to collect data on long term quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Patients included in the randomized meta-trial evaluating awake prone position versus control among COVID-19 patients on high-flow nasal oxygen therapy (Ehrmann 2021).
* Patients alive at D28
* No opposition to participate in the research which evaluates mortality and quality of life by telephone interview.

Exclusion Criteria:

* Patients lost to follow-up after 28 days.
* Withdrawal of consent from randomized meta-trial by patient
* Vulnerable person: safeguard of justice, curatorship, or guardianship
* Patients refusing to answer telephone questionnaire.