cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Long-term Safety of QVA149

The study is designed to provide long-term safety data for QVA149 in patients with moderate to severe chronic obstructive pulmonary disease (COPD).


Eligibility Criteria:
Inclusion Criteria:

* Male or female adults aged ≥40 yrs
* Smoking history of at least 10 pack years
* Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008)
* Post-bronchodilator FEV1 \< 80% and ≥ 30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) \<70%

Exclusion Criteria:

* Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1
* Patients with concomitant pulmonary disease
* Patients with a history of asthma
* Any patient with lung cancer or a history of lung cancer
* Patients with a history of certain cardiovascular co-morbid conditions
* Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
* Patients in the active phase of a supervised pulmonary rehabilitation program
* Patients contraindicated for inhaled anticholinergic agents and β2 agonists
* Other protocol-defined inclusion/exclusion criteria may apply
Chest Pain Unit II Register

Multicentric, prospective, non-interventional observational study with two parts:

1. A register of quality assurance within the recertification of clinics
2. An extended register with scientific protocol.

1. Quality assurance

   As a quality-assuring basic register, the CPU II register checks the extent to which certified Chest Pain Units fulfill the criteria published by the DGK. In particular, the following quality dimensions are evaluated:
   * Indication quality
   * Diagnostic quality
   * Therapeutic quality
   * Structural quality / networking
2. Platform for projects with a scientific focus

The CPU II register and the infrastructure provided are a platform for further projects with scientific questions (scientific protocol = WP):

WP: Clinical history after CPU (PCI data / discharge / 12-month FUP) in patients with leading cardiac diagnosis

Eligibility Criteria:
Inclusion Criteria:

* CPU patient
* \> 18 years
* Written consent of the patient

Exclusion Criteria:

* Denied consent
An Effectiveness And Safety Study Of PD 0299685 For The Treatment Of Symptoms Associated With Interstitial Cystitis

The purpose of this study is to determine whether PD 0299685 is effective in the treatment of symptoms associated with interstitial cystitis/painful bladder syndrome, such as pain, urinary urgency and frequency. At the same time assess the drug's safety and tolerability.


Eligibility Criteria:
Inclusion Criteria:

* Men and women over 18 years of age with moderate to severe interstitial cystitis defined by pain score.
* Women must not be pregnant or lactating, They may be post-menopausal, surgically sterilized or using an appropriate method of contraception.

Exclusion Criteria:

* History of interstitial cystitis less than 6 months
* History of current or recurrent urinary tract infections, or genitourinary cancer
* Any previous urinary diversion procedure with or without bladder removal, bladder augmentation
* Use of certain drugs given into the bladder up to 1 month prior to study entry
Lifestyle Changes in Patients With Type 2 Diabetes Mellitus and Hypertension

Data obtained in hypertensive patients without diabetes suggest that increased association of non-pharmacological treatment in patients with diabetes and hypertension may be associated with an improvement in blood pressure control. Despite the beneficial results found, is not yet known the magnitude of the effect of a DASH diet associated with the stimulus of physical activity on BP in patients with type 2 diabetes. The beneficial effects on blood pressure of an additional non-pharmacological intervention to drug therapy may have an even greater impact in patients with treatment-resistant hypertension The aim of this study is to evaluate the effect of changes in lifestyle on blood pressure in patients with type 2 diabetes and hypertension resistant to treatment.

The aim of this study is to evaluate the effect of changes in lifestyle on blood pressure in patients with type 2 diabetes and hypertension. Secondary objectives are: Assess whether the prescription of a DASH-type diet and encouragement for physical activity through use of pedometers, can improve blood pressure control in patients with type 2 diabetes and hypertension resistant to treatment.

Forty type 2 diabetic with resistant hypertension outpatients were included in a randomized clinical trial: treatment 1- DASH diet + encouragement for physical activity through use of pedometer; treatment 2- ADA diet + usual exercises. The duration of each treatment are four weeks. The patients included should have performed Ambulatory Blood Pressure Monitoring (ABPM) to exclude white-coat effect, ie when there are abnormal in the measurement of office blood pressure (equal to or above 140/90 mm Hg) and normal blood pressure by ABPM during the awake period (equal to or below 135/85 mm Hg). Twenty-four hour records with concurrent 24h urinary collections (protein intake estimative), clinical and laboratory evaluation were performed at baseline and after 4 weeks. Serum fatty acids were measured in total lipids by gas chromatography.

Eligibility Criteria:
Patients

Inclusion Criteria:

* type 2 diabetes
* Blood pressure ≥140/90 mm Hg
* ABMP ≥ 135/85 mm Hg

Exclusion Criteria:

* digestive disease with malabsorption
* diabetic neuropathy with gastroparesis
* BMI ≥ 40 kg/m²
Proof of Concept Study of Cognitive Improvement in Patients With Schizophrenia

The purpose of this study is to demonstrate that AZD3480 improves cognition in patients with stable schizophrenia who are being treated with an atypical antipsychotic and who are active cigarette smokers, to assess the safety and tolerability of AZD3480 and to define the optimal dose(s) to be used in future trials.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia
* Outpatient at the time of screening and randomization
* Stable housing defined as having a place to live in the community (ie, not in a hospital or nursing home)
* Active cigarette smoking (10 or more cigarettes per day

Exclusion Criteria:

* Any significant psychiatric or neurological disease other than schizophrenia, or current diagnosis of major depressive disorder
* Known or suspected drug or alcohol abuse within the 6 months or urine toxicology test positive for illegal or non-prescribed substances
* Impaired vision and/or hearing making cognitive testing difficult
Effects of FSH on Endothelial Function (FEND)

Purpose of the study will be to evaluate the effects of the s.c. administration of 300 IU of FSH in 16 healthy males. The endothelial function will be evaluated by the measurement with ecographic approach of the flow mediated dilation (FMD) of the brachial artery. The FMD will be measured before and 6, 12, 24 or 48 hours after FSH or placebo adiministration in the same subjects studied 2 weeks apart. The results will help to clarify whether perturbation of FSH, similar to the one observed in women after the menopause, affect endothelial function.

The effects of follicle-stimulating hormone (FSH) have been poorly studied. In women, FSH is involved in estrogen production, while in men regulates spermatogenesis. On the other hand, in women, menopause is associated with an increase in the risk of cardiovascular disease and the concentration of FSH rises. It is unclear whether such an increase has any effect on the development of atherosclerosis. Endothelial dysfunction represents an early trigger of atherosclerosis. Since estrogens can directly stimulate endothelial function and increase in response to FSH administration, males might represent a potential model to study the effcts of FSH independent from estrogens.Purpose of the study will be to evaluate the effects of the s.c. administration of 300 IU of FSH in 16 healthy males. The endothelial function will be evaluated by the measurement with ecographic approach of the flow mediated dilation (FMD) of the brachial artery. The FMD will be measured before and 6, 12, 24 or 48 hours after FSH or placebo adiministration in the same subjects studied 2 weeks apart. The results will help to clarify whether perturbation of FSH, similar to the one observed in women after the menopause, affects endothelial function.

Eligibility Criteria:
Inclusion Criteria: Healthy volunteers -

Exclusion Criteria:

-
Optimal Protein Supplementation for Critically Ill Patients

It is well accepted that during critical illness there is an increase in protein breakdown and loss of lean body mass. Previous studies have shown that during critical illness muscle breakdown increases dramatically. The aim of our study is to test the hypothesis that critically ill patients have improved outcomes with higher protein supplementation.


Eligibility Criteria:
Inclusion Criteria:

* • Medical or surgical patients who are admitted or transferred to the ICU with an APACHE II score greater than or equal to 18 and who are candidates for enteral nutrition within 48 hours of admission.

Exclusion Criteria:

* • Patients who cannot tolerate enteral nutrition

  * Patients who have a contraindication for enteral nutrition per American Society of Enteral and Parenteral Nutrition guidelines (GI obstruction, intractable nausea and/or vomiting, short bowel syndrome, distal GI fistula, GI bleeding that will require endoscopy, malabsorption that requires TPN, inability to access the GI tract
  * Patients with chronic stage III or IV kidney disease and/or patients receiving dialysis within six months of this hospital admission as these patients are known to require specific protein diets as an outpatient. Patients with acute kidney injury will not be excluded as there is no evidence to suggest these patients require a specific protein diet secondary to their acute kidney injury.
  * Patients with refractory hypotension unresponsive to vasoactive medications
  * Patients who are unlikely to survive the next 48 hours at the time of enrollment (this will be judged by the treating physician)
  * Patients who are unable to give consent and do not have a family member able to give consent on his/her behalf.
  * Patients with end stage liver disease or undergoing liver transplant or liver resection surgery
  * Patients whose physician thinks he/she should not participate
  * Prisoners
  * Pregnant women (all female of childbearing age will have a urine pregnancy test prior to randomization)
Study in Healthy Volunteers to Assess the Pharmacokinetics of Midazolam Administered Alone and in Combination With Vandetanib

The purpose of this study in healthy volunteers is to assess the Pharmacokinetics (PK) of Midazolam administered alone and in combination with Vandetanib.

A Phase I, Open-label, Single-center Study to Assess the Pharmacokinetics of Midazolam, a CYP3A4 Substrate, in Healthy Subjects When Administered Alone and in Combination with a Single Dose of 800-mg Vandetanib (CAPRELSA)

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study
* specific procedures:

  * Volunteers must be males or females aged 18 to 50 years and with a weight of at least 50 kg and body mass index (BMI) between 18 and 30 kg/m2, inclusive
  * Females must have a negative pregnancy test at screening and on admission to the study center.
  * Females must not be lactating and must be of non-childbearing potential defined as postmenopausal or documentation of irreversible surgical sterilization.

Exclusion Criteria:

* History of any clinically significant disease or disorder such as gastrointestinal, hepatic, renal or skin disease.
* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity,
* Volunteers who smoke more than 5 cigarettes per day or are unable to refrain from smoking while resident in the study center
* Screening blood pressure of greater than 140/90 mmHg and/or a resting heart rate of less than 45 beats per minute (repeat test allowed at the Investigator's discretion)
* Clinically significant abnormal12-lead ECG as assessed by the Investigator,
* QTcF interval greater than 450 ms
* Any positive result on screening for:

  * serum hepatitis B surface antigen,
  * hepatitis C antibody, and
  * human immunodeficiency virus (HIV), or
* Positive screen for drugs of abuse.
Biomarkers in Patients Hospitalized With Suspected Acute Myocardial Infarction

The concentration of troponins in plasma is used for diagnosing acute myocardial infarction. Different types of heart-specific troponins can be measured and with different analytical methods. The primary aim of this study is to evaluate the diagnostic characteristics of a new analytical method for measuring troponin I in diagnosing acute myocardial infarction.


Eligibility Criteria:
Inclusion Criteria:

* hospitalized at St. Olavs hospital
* blood sampled for troponin analysis due to suspicion of acute myocardial infarction without ST-elevations on ECG less than 4 hours after admitted to the hospital

Exclusion Criteria:

* residency outside Norway
* does not understand Norwegian
A Study of BBI503 in Advanced Solid Tumors, or BBI503/ Sorafenib in Advanced Hepatocellular Carcinoma

This is an open-label, multicenter, phase 1 dose escalation study of BBI503 monotherapy, or BBI503 in combination with Sorafenib. This study population is adult patients with advanced solid tumors in monotherapy, or adult patients with advanced hepatocellular carcinoma in combination therapy.


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent.
* ≥ 20 years of age
* Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last BBI503 dose
* Females of childbearing potential must have a negative serum pregnancy test
* Adequate organ function
* Life expectancy ≥ 3 months

Exclusion Criteria:

* Any known symptomatic or untreated brain metastases
* Pregnant or breastfeeding
* Crohn's disease, ulcerative colitis extensive gastric and small intestine resection
* Unable or unwilling to swallow BBI503 daily
* Uncontrolled concurrent disease
* Received other investigational drugs within 4 weeks prior to first dose
* Prior treatment with BBI503
Comparison of the Efficacy of Ultrasound-guided Greater Occipital Nerve Block and Pulsed Radiofrequency Therapy in Chronic Migraine Patients

Chronic migraine (CM) is related to headache-related disability and reduced quality of life. Therefore, patients with CM require preventive treatment. The aim of this double-blind, comparative-effectiveness study was to compare ultrasound-guided great occipital nerve (GON) block and pulsed radiofrequency (PRF) application in CM patients.

The study consisted of 2 groups: GON block (group GONB) and GON block + pulsed RF (group GONB+PRF). Each group had 16 patients. Ultrasound-guided GONB was performed to locate the nerve more accurately. With 0.5 Hz sensorial stimulation, a 5-cm-long radiofrequency needle was advanced under ultrasound guidance in both groups. GON block was performed in all patients by administering 5mg bupivacaine through a PRF needle. After the GON block, the PRF neuromodulation was applied at 42 degrees for 4 minutes in the GONB-PRF group. In the GONB group, no pulse was given. The patients were examined for follow-ups at the 1st, 2nd, 3rd, and 6th months after the procedure. The severity and the number of migraine attacks, and the number of analgesic drugs were noted.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65;
* ICHD-3 defined chronic migraine

Exclusion Criteria:

* Patients who had been started on an effective preventive medication within the past three months;
* Medication-overuse headache;
* Treatment with peripheral nerve blocks, trigger point injections or botulinum toxin injections within the past three months;
* Known allergic reaction to local anaesthetics;
* Pregnancy or nursing;
* History of another headaches;
* History of chronic medical conditions (e.g. cardiovascular, hepatic, renal, endocrine);
* History of other chronic pain syndromes (e.g. low back pain and fibromyalgia).
Randomized Trial of In-Home Cervical Cancer Screening in Underscreened Women

The purpose of this trial is to determine whether mailing in-home human papillomavirus (HPV) screening kits is effective in increasing uptake of cervical cancer screening and early detection and treatment of cervical neoplasia in underscreened women.

Over half of all cervical cancers in the U.S. are diagnosed in unscreened or underscreened women. New national guidelines identify increasing screening uptake as the number one priority for reducing cervical cancer-related morbidity and mortality. Innovative screening strategies that eliminate the need for clinic-based screening could be highly effective in improving screening compliance while maintaining high-quality care. We propose a large, pragmatic randomized controlled trial within Group Health (a large integrated health care delivery system in Washington State) to compare effectiveness of two programmatic approaches to increasing cervical cancer screening among overdue women. The first approach (control arm) is usual care at Group Health, which consists of patient- and provider-level services to promote adherence to Pap screening, and the second approach (intervention arm) includes usual care plus a mailed in-home high-risk human papillomavirus (hrHPV) screening kit. We will randomize eligible women to the in-home hrHPV screening arm or the usual care arm. Compared to usual care, we hypothesize that in-home hrHPV screening will enhance early detection and treatment of cervical neoplasia and improve compliance with screening. The trial will provide definitive evidence-based data on the impact of an in-home hrHPV screening program in a real-world clinical setting.

Eligibility Criteria:
Inclusion Criteria:

* Female
* 30 to 64 years of age
* Have a primary care provider at Group Health
* Received annual "birthday letter" with Pap screening reminder 5 months earlier
* No Pap test in the past 3.4 years
* Continuously enrolled at Group Health for at least 3.4 years
* No hysterectomy

Exclusion Criteria:

* Currently pregnant
* Language interpreter needed
* On "do not contact list" for research studies
EUS-RFA PANCARDINAL-1 Trial

The objectives of this study are to determine the feasibility, tolerability, and treatment effect of endoscopic ultrasound (EUS) radiofrequency ablation (RFA) plus standard-of-care neoadjuvant chemotherapy (NAC) in the treatment of pancreatic ductal adenocarcinoma (PDAC). Endoscopic ultrasound (EUS) radiofrequency ablation (RFA) and neoadjuvant chemotherapy (NAC) will be performed before tumor resection surgery, with the goal of shrinking a tumor or stopping the spread of cancer so that surgery might be less invasive and more effective.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed and histologically-confirmed PDAC by biopsy
* Permanent street address
* Consent to study participation
* Axial CT scan consistent with PDAC
* No prior chemotherapy or less than 2 months of pre-operative chemotherapy for PDAC
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Exclusion Criteria:

* Male or female patients \< 18 years of age
* No permanent street address or telephone number
* Pregnant patients
* Inmates or prisoners
* Unable to provide informed consent
Observational Real-world Evidence (RWE) Study to Assess Patient-reported Wellbeing Using Tildrakizumab in Live Setting - POSITIVE Study

This is an ethics-approved, multi-national, multi-site Phase IV, 1-cohort prospective observational study. The main purpose of this study is to assess the effect of tildrakizumab on the overall wellbeing in patients with moderate-to-severe psoriasis using the 5-item World Health Organization Wellbeing Index (WHO-5) questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Patient with diagnosis of moderate-to-severe chronic plaque psoriasis documented in the medical chart.
* Patient who need systemic biologic therapy and qualify for treatment with an IL-23p19 inhibitor. Tildrakizumab must be the anti-IL-23p19 selected therapy before including the patient in the study.
* Patient aged 18 years or older at the time of patient recruitment.
* Patient who have provided written informed consent (if required by country regulations).

Exclusion Criteria:

* Patients unable to comply with the requirements of the study (fulfilling of the study questionnaires) or who, in the opinion of the study physician, should not participate in the study.
* Patients included in a clinical trial.
Mental Stress & Diesel Exhaust on Cardiovascular Health

This study uses an experimental design to conduct a double-blind, randomized, crossover study where participants receive both diesel exhaust and a mental stress test in a controlled setting. My hypothesis is that the synergistic effect of stress and air pollution will result in higher levels of stress and inflammation (measured via biological markers) as well as poorer cardiovascular disease related outcomes compared to the independent effect of each exposure separately.


Eligibility Criteria:
Inclusion Criteria:

Non-smokers without history of high blood pressure, asthma, diabetes, high cholesterol, post-traumatic stress disorder (PTSD) or any other chronic condition that requires ongoing care.

Exclusion Criteria:

1. Smoking: We rule out active smoking by checking urine cotinine during our study.
2. History of high blood pressure: We objectively measure BP during in-person screening and exclude those with blood pressure (\>130/85 mmHg).
3. Asthmatic: Spirometry is done at screening to rule out asthma.
4. Diabetic: We obtain fasting blood sugar to rule out diabetes at screening (\>125 mg/dL)
5. Cholesterol: We obtain fasting blood lipid levels to rule out hypercholesterolemia at screening (\>200 mg/dL).
6. History of PTSD: Subjects will be asked about prior PTSD diagnosis during the phone and in person screen.
7. Any other chronic condition requiring ongoing care based on medication use.
8. A body mass index (weight in kilograms divided by height in meters squared) greater than 26 and less than 18.5
9. A female of childbearing age with a positive pregnancy test
10. A female of childbearing age who is unwilling to use effective contraception during the study