cyrilzakka/clinical-trials huggingface dataset:
Depression and Anxiety in Rheumatoid Arthritis

The primary endpoint of this study is to evaluate the prevalence of anxiety and depressive disorders, and their relationship with disease activity, in patients with rheumatoid arthritis treated with biological drugs

The prevalence of anxiety and depressive disorders will be assesed with the HADS questionnaire at the time of the visit

Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* diagnosis of rheumatoid arthritis according to 2010 Classification American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Criteria
* being able to compile questionnaire
* current treatment with biological disease-modifying antirheumatic drug

Exclusion Criteria:

* Current treatment for anxiety or depressive disorder
Clinical Trial of Uterine Artery Embolization for Uterine Leiomyoma

The efficacy and safety of uterine artery embolization, as compared with standard surgical methods, for the treatment of symptomatic uterine fibroids remain uncertain. The purpose of this trial is to evaluate the uterine volume and tumor size reduction, symptomatic relief, complication, fertility, ovarian function and quality of life with uterine artery embolization for uterine fibroids comparing with standard surgical methods.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of symptomatic uterine leiomyoma

Exclusion Criteria:

* pregnancy
* iodine agent allergy
* patient refuse to take part in this trial
* tumour size is less than 3cm or beyond 10cm
* with endometriosis
* with malignant diseases
* with abnormal coagulation function which can't restore
* with acute inflammatory diseases or acute episode of chronic inflammatory diseases
* with severe heart, lung, liver and kidney, et al. organ diseases.
First-in-human Single and Multiple Dose Trial of ATR-258

This is a single-site, randomized, double-blinded, placebo-controlled, First-in-Human trial, conducted in 3 parts.


Eligibility Criteria:
Inclusion Criteria Phase A and B:

* Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
* Body mass index (BMI) within the range 18.5 - 29.9 kg/m2 (inclusive) at screening.
* Male

Inclusion Criteria Phase C:

* Participant must be 30 to 75 years of age inclusive, at the time of signing the informed consent.
* BMI within the range 25.0 to 45.0 kg/m2 and body weight from 80 to 160 kg (inclusive) at screening.
* Male

Exclusion Criteria Phase C:

* Type 1 diabetes mellitus (T1DM) or ketosis-prone T2D based on diagnosis
Vitamin D Levels in Residents in Medicine

the study aims to messure the vitamin D levels in medical staff in the hospital. The physicians in the course of their internship who work indoors and work many night shifts have limited sun exposure in all seasons. Nursing staff who work shifts and work indoors are at the same risk of liltle sun exposure. The study addresses the amount of sun exposure, assessed by a sun exposure questioner, age, gender,work load related to number of shifts in the physicien group and in nursing group the job percentile we also adress religion (clothing cover)as a factor.

The population in Israel is heterogeneous in the aspect of skin exposure to the sun. Women in the Moslem community with traditional long sleeve dress code whose sun exposure to the sun even in the summer months is limited.

The physicians in the course of their internship who work indoors and work many night shifts and nurses with their shift work have limited sun exposure in all seasons.

The study addresses the amount of sun exposure, assessed by a sun exposure questioner, age, gender,number of shifts in the physicien group and in nursing group the job percentile religion (clothing cover).

The standard for measuring vitamin D status is 25(OH) D levels in the serum. The staff members from which blood will be drawn will be have an explanation about the aim of the study and will sign an informed consent.

Eligibility Criteria:
Inclusion Criteria:medical staff Exclusion Criteria:pregnancy
Risperidone for the Treatment of Cocaine Dependence - 7

The purpose of this study is to evaluate clinical safety and pharmacological efficacy in the treatment of cocaine dependence, to evaluate impact of treatment on craving, and to correlate evidence of baseline neurotoxic damage of cocaine with treatment outcome and clinical side-effects.


Eligibility Criteria:
Inclusion Criteria:

M/F ages 21-50. Meet DSM-IV criteria for cocaine dependence. Agree to conditions of the study and sign informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nursing women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.
A Study of the Combination of Multiple Doses of RO5285119 With a Single Dose of Risperidone in Healthy Volunteers

This single-center, randomized, double-blind, two-period crossover study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effects of the combination of multiple doses of RO5285119 with a single dose of risperidone in healthy volunteers. Subjects will be randomized to one of 4 treatment sequences of two periods to receive multiple doses of RO5285119 plus a single dose of risperidone or risperidone placebo or multiple doses of RO5285119 placebo plus a single dose of risperidone or risperidone placebo, with a washout period of approximately 3 weeks between treatment periods. Anticipated time on study is up to 12 weeks (from screening through study completion).


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female adults, 18 - 50 years of age inclusive Healthy status is defined by absence of evidence of any active or chronic disease following detailed medical and surgical history and a physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology and urinalysis
* Body mass index (BMI) 18 to 30 kg/m2 inclusive
* Women have to be postmenopausal or surgically sterile
* Male subjects must use a barrier method of contraception for the duration of the study and for 3 months after last dosing

Exclusion Criteria:

* Suspicion of regular consumption of drug of abuse, or history of drug or alcohol abuse
* Positive for hepatitis B, hepatitis C or HIV infection
* History of clinically significant hypersensitivity or allergic reactions
* Disorders of the central nervous system, including psychiatric disorders, behavioural disturbances, cerebrovascular events, depression, bipolar disorder, migraine, Parkinson
* Regular smoker (\>5 cigarettes, \>3 pipe-fulls, \>3 cigars per day)
* Administration of an investigational drug or device within 3 months prior to first dosing

  * Hypersensitivity to risperidone or any of its excipients
* Any other known contraindications to risperidone as stated in the SmPC
Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients

Intra-dialytic hypotensive (IDH) events can be defined as an abrupt decline in blood pressure that cause symptoms and/or require an intervention. They are common, affecting up to one third of maintenance HD sessions. Detrimental associations include: development of myocardial stunning, cerebral hypo-perfusion, vascular access thrombosis and greater mortality.

Rapid solute removal by HD generates temporary osmotic gradients between the intra-vascular and intra-cellular compartments, promoting trans-cellular fluid movement and resultant hypotension. Manipulation of osmotic gradients, e.g. using higher dialysate sodium (DNa), may ameliorate excess SBP decline during HD.

This study aims to assess the effects of higher (142 mmol/L) versus lower (138 mmol/L) dialysate sodium (DNa) use in adult chronic hemodialysis patients admitted to hospital on intra-dialytic blood pressure and biomarkers of cardiac ischemia.

The investigators will randomly assign subjects to higher versus lower DNa during their hospital stay, up to a maximum of six HD sessions.


Eligibility Criteria:
Inclusion Criteria:

* Chronic HD (\>90 days)
* Age ≥18y
* Informed consent
* First admission during study period.

Exclusion Criteria:

* Use of pressors
* Pre-dialysis serum sodium \<=128mmol/L or \> 145 mmol/L
* Pre-dialysis SBP \>180 mmHg
* Intensive care stay earlier in admission
* Expected length of stay \<24 hours (e.g. admission for HD access procedure)
* Acute coronary syndrome within seven days
* Acute stroke
* Institutionalized individuals
* Pregnancy
Improving Maternal Cardiovascular Outcomes Through the Implementation of a Hypertensive Disorders of Pregnancy Bundle in Nigeria

The goal of this interventional study is to learn from patients and healthcare providers at 4 health institutions (study sites) in Abuja and Kano in Nigeria what ways to best develop the content of a Hypertensive Disorders of Pregnancy ( HDP) Management package for pregnant women, and evaluate the effectiveness of implementing this package in improving cardiovascular health of pregnant women. The main question it aims to answer is:

Will a contextualized home BP monitoring program lead to better BP control among patients with HDP in Nigeria?

This study aims to contextualize, implement, and evaluate the feasibility, fidelity, and acceptability and effectiveness of: 1) postpartum remote blood pressure monitoring, 2) patient education, 3) development of a standardized postpartum follow-up protocol, and 4) provision of free and/or subsidized antihypertensive medications for patients with HDP in University of Abuja, Murtala Muhammad Specialist Hospital, National Hospital, Abuja and Aminu Kano Teaching Hospital all in Nigeria. These components collectively make up a contextualized postpartum BP monitoring program called the HDP Implementation Bundle. The long-term objective is to implement a contextualized and acceptable evidence-based postpartum home BP monitoring program with supporting services and components, at 4 tertiary care institutions in Nigeria, to improve postpartum BP control in patients with HDP using a multilevel approach.

Eligibility Criteria:
Inclusion Criteria:

* Postpartum adults (\>18 years)
* postpartum emancipated minors (in accordance with the Nigerian guidelines for young persons' participation in research and reproductive health services)
* with diagnosis of HDP prior to delivery delivered at one of the participating sites able to provide informed consent.

Exclusion Criteria:

* unable to provide consent.
Lung Impedetiometric Modification in SBT and Extubation Failure

Weaning is the entire process aimed at liberating patients from mechanical ventilation and endotracheal intubation. Weaning should be considered as early as possible in order to reduce the time spent in invasive mechanical ventilation (iMV), which is associated with morbidity and mortality. To verify if patients are ready to be extubated, a spontaneous breathing trial (SBT) is performed. At this stage some clinical indices and objective parameters are evaluated, such as the breathing pattern, gas exchange, haemodynamic stability and patient's comfort. In case of SBT success, the patient can be extubated. However, a post-extubation respiratory failure can occur within the first 48 hours after extubation, thus making extubation unsuccessful. Some patients considered at risk for post-extubation respiratory failure benefit from the application of non-invasive ventilation (NIV) after extubation. Early characterization of these patients is crucial to improve their clinical outcomes.

Electrical Impedance Tomography (EIT) has been introduced in clinical practice as a non-invasive bedside monitoring tool to evaluate the aeration and ventilation of different lung regions. EIT has been proposed to guide ventilator settings adjustments in critically ill patients and to monitor prolonged weaning. However, the potential of EIT to assess SBT and after extubation in a general ICU population has never been evaluated insofar.

The present study aims to describe the modifications of lung aeration, ventilation and inhomogeneity occurring during SBT and after extubation in a general population of critically ill patients at the first SBT attempt.


Eligibility Criteria:
Inclusion Criteria:

* Glasgow Coma Scale ≥8
* presence of clearly audible cough during suctioning with need for tracheal suctioning ≤2/hour
* normal sodium blood values
* core temperature \<38.5° during the previous 8 hours
* Arterial partial pressure of oxygen to inspired oxygen fraction (PaO2/FiO2) ≥200 mmHg, with a Positive End Expiratory Pressure ≤5 cmH2O and FiO2 ≤0.4
* stable cardiovascular status (i.e., HR ≤140 beats/min, sBP between 90 and 160 mmHg without need for vasopressin, epinephrine or norepinephrine infusion, or with dopamine or dobutamine infusion ≤5 mcg/kg/min)
* cuff leak volume \>110 mL

Exclusion Criteria:

* major heart arrhythmias or cardiac ischemia
* pneumothorax or emphysema
* recent (1 week) thoracic surgery
* presence of chest burns
* pregnancy
* inclusion in other research protocols
Vasomotor Symptoms (VMS) Progesterone Study: Vasomotor Symptoms and Endothelial Function - Trial of Oral Micronized Progesterone

The primary purpose of this study is to determine the effects of a full dose (300 mg at hs) of oral micronized progesterone (OMP) on vasomotor symptoms \[VMS\] (hot flushes/night sweats), on forearm blood flow and on lipid levels and blood pressure in menopausal women without cardiovascular disease and with moderate to severe VMS.

The hypotheses are that progesterone will improve hot flushes, increase endothelium-dependent forearm blood flow and will decrease blood pressure without change in lipid levels.

In this 4-month study, menopausal women are randomized to either placebo or oral micronized progesterone (Prometrium®). Participants maintain a daily diary to keep track of their vasomotor symptoms and other factors. Forearm blood flow will be assessed by venous occlusion plethysmography at baseline and after three months of therapy. Screening tests at baseline to rule out heart disease include measurement of blood pressure and heart rate, electrocardiogram (ECG) and blood tests - fasting blood glucose and lipid profile.

Collection of serum and plasma samples at baseline and end of therapy for analysis of cardiovascular markers (e.g., c-reactive protein) and clotting and fibrinolytic markers. Continued daily diary collection for one month after therapy discontinuation to look for possible rebound effects. Analysis of outcomes will be by analysis of covariates, with final value as the outcome, therapy as factor and baseline values as covariate.

Eligibility Criteria:
Inclusion Criteria:

1. Menopausal women (final menstrual period one or more but less than 10 years before)
2. No evidence of vascular disease (normal BP; without diabetes mellitus; normal cholesterol levels and non-smoker for at least a year; and normal ECG.)
3. Moderate to severe VMS during the day and night.

Exclusion Criteria:

1. Any menstruation in the preceding year.
2. History of hysterectomy without ovariectomy unless 60 years of age.
3. Use of ovarian hormone therapy (estrogen, progestin, progesterone or androgen) or selective estrogen receptor modulator (SERM) therapy (raloxifene or tamoxifen) in the preceding six months.
4. Body mass index (BMI) over 35 or less than 20.
5. Mean of several pre-treatment blood pressures over 145/95.
6. Documented abnormal cholesterol; abnormal fasting capillary glucose; abnormal angiogram; ECG or exercise stress tests or a diagnosis of diabetes mellitus; or any history suggestive of angina.
Preoperative and Intraoperative Sonographic Assessment of Lower Uterine Segment Thickness at Term in Women With Previous Cesarean Delivery - a Ultrasound Method Comparison Study

This prospective, clinical, observational study compares preoperative and intraoperative sonographic assessment of lower uterine segment of women who underwent ≥ second cesarean section.

It is the purpose of the study to assess transabdominal (linear/convex ultrasound probe) and transvaginal approach versus intraoperative sonographic assessment of lower uterine segment.

In 1991, 126.297 (15.3%) women delivered by caesarean section in Germany. Since then, the rate of caesarean section increased steadily over the next 20 years, reaching up to 32.2% in 2011 \[https://www.destatis.de\]. The absolute risk of uterine rupture in vaginal birth after Caesarean section is 1 in 100 deliveries. The risk of perinatal death or the outcome of extremely neurological impairment is 1 in 1000 deliveries \[Cunningham et al., 2009\].

Statistically more than 300 pregnant women with a prior caesarean delivery visit daily ultrasound departments of german hospitals to investigate the C-section scar before delivery. They have one important question: Is it possible to predict successful trial of labor after cesarean delivery? \[AQUA-Institut\] The information for the risk of uterine rupture remains insufficient based only on ultrasonography assessment \[Varner et al., 2012\].

The measurement technique for lower uterine segment (myometrial) thicknesses in the third trimester have been described by several authors. Using a combination of preoperative transvaginal and transabdominal (linear/convex probe) ultrasound, we compare with intraoperative sonographic assessment of lower uterine segment of women who underwent ≥ second cesarean section.

The aim of the present study is to assess transabdominal (linear/convex ultrasound probe) and transvaginal approach versus intraoperative sonographic assessment of lower uterine segment.

This will allow the investigators to draw conclusions regarding the best method to assessment of lower uterine segment (myometrial) thickness in the third trimester to predict successful trial of labor after cesarean delivery.

Eligibility Criteria:
Inclusion Criteria:

* pregnancy after previous cesarean section
* pregnancy between 37 0/7 and 42 0/7 weeks of gestation
* primary or secondary indication for cesarean section
* ability to give informed consent in german or english

Exclusion Criteria:

* emergency caesarean section
* \<18 years old
Explaining the Invisible Using the PEARL System

Radiotherapy uses high doses of x-rays directed at tumours to kill them, an unfortunate side effect is healthy surrounding tissue will receive some of the x-ray dose and is damaged. Approximately 22% of radiotherapy patients receive treatment to cure prostate cancer. The technique used requires patients to maintain full bladder and empty bowel because they are next to the prostate, the aim of radiotherapy planning is to minimise the radiation dose received to healthy organs and tissues as this will reduce side effects. PEARL is commercial interactive PC software that shows realistic and functional 3D models of Linac's (machines that deliver radiotherapy treatment). Using PEARL it's possible to display realistic patient treatments including how an individual would be laid on a treatment couch and how the machine will move and sound during treatment. Additionally PEARL provides the opportunity to look inside the body to view internal anatomy and show where the radiotherapy treatment is directed.

Information prior to treatment in radiotherapy is normally given verbally one to one. The investigators believe this information can be more easily understood if PEARL is used in conjunction with this verbal exchange. PEARL gives visual and audio representation of the treatment experience, and demonstrates the reasons behind required preparations.

Research aim is to demonstrate patients who receive information using PEARL have greater understanding, reduced anxiety and reduced radiation dose. This will be tested using two groups of patients receiving radiotherapy to the prostate. Group A - Verbal information, Group B - Verbal information and PEARL demonstration. Data collection is via patient questionnaires and review of Cone Beam Computer Tomography (CBCT) images that are taken prior to each radiotherapy treatment as standard practice. CBCT's are used to locate the treatment area and assess bladder and bowel status and ensure all of these are suitable to deliver treatment accurately.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with cancer of the prostate of the following staging: T1-3b, N0-1, M0.
* Clinical intention to treat using external radiotherapy based on three local departmental protocols: TP-CP-97, TP-CP-98 and TP-CP-99. These protocols dictate that the patients receive VMAT planned treatment, require a full bladder and empty rectum and require daily localisation using kV cone beam CT (CBCT).
* Patients consented to the study.

Exclusion Criteria:

* Patients who do not fulfil the inclusion criteria.
* Patients diagnosed with depression.
* Blind patients or patients with severe visual impairment.
* Patients with reduced understanding due to mental impairment.
* Patients not willing to consent to the study.
* Prisoners and young offenders.
* Patients who are unable to understand verbal explanations given in English.
Pharmacokinetics of Melatonin Administered in Oral, Lotion, and Bubble Bath Formulations

Melatonin is a hormone that promotes sleep that is available without a prescription in the United States. In addition to oral supplements, melatonin can be purchased in the form of lotions and bubble baths with unknown dosage and no frequency or age recommendations. In this study, researchers will examine how quickly melatonin in lotion and bubble bath is absorbed compared to oral tablets, as well as how long the melatonin lasts in the body.

Melatonin is a hormone that promotes sleep that is available without a prescription in the United States. In addition to oral supplements, melatonin can be purchased in the form of lotions and bubble baths with unknown dosage and no frequency or age recommendations. A previous study (unpublished) has shown that a small amount of an over-the-counter lotion increases salivary melatonin levels by up to 1000 fold, a startling amount. Researchers will characterize the time course of the absorption and metabolism of lotion- and bubble bath-based melatonin compared to oral tablets in healthy 18-22 year olds.

The peak level, time to peak level and half-life of melatonin will be compared between the administration routes using a within-person (repeated measures) design and saliva sampling over 48 hours. Participants can choose specific days to participate within a one-month window, with a maximum of four sampling periods. All participants will collect control saliva samples (no melatonin treatment) one night at 10 PM and 4 AM. Participants will be asked to have two treatments 1) oral melatonin and 2) either lotion melatonin or bubble-bath melatonin. Participants can indicate if they have a preference for lotion vs. bubble bath or if they are willing to undergo both lotion and bubble bath treatments (adding a fourth sampling period). Order will be randomized.

For the treatments, saliva sampling times are as follows: Prior to melatonin administration (10 AM), then 15 min, 30 min, 45 min, 60 min, 90 min, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours (10 PM), 18 hours (4 AM), 24 hours, 36 hours, and 48 hours after administration. Samples will be frozen at the participant's home until returned to the researchers at a later date. Melatonin in saliva samples will be quantitated via Enzyme Linked Immunosorbent Assay.

Eligibility Criteria:
Inclusion Criteria:

* University of Redlands student

Exclusion Criteria:

* Allergies or sensitivities to scented lotions or bath products
* Pregnancy