cyrilzakka/clinical-trials huggingface dataset:
The Use of a Forecasting System for Predicting Exacerbations of COPD

People with Chronic Obstructive Pulmonary Disease (COPD) often have periods during the year when their symptoms become worse. These are often due to an infection and are called "exacerbations" by doctors. Exacerbations are more common in the winter and also seem to be related to particular types of weather. As well as forecasting the weather the UK Met Office has developed a system to try to predict when exacerbations are likely to occur. The main purpose of this research study is to find out whether the Met Office forecasting service can predict when exacerbations are more likely to occur and whether the advice given during the predicted higher risk periods leads to fewer patients having an exacerbation or if it reduces the impact of the exacerbation. The study will also assess if there is a link between viral or bacterial infection and breathing problems that occur during the study period. The study will also collect information about possible causes of the breathing problems and what happens to the person afterwards. The results of this study will help us learn more about breathing problems which may lead to new research studies that would aim to improve the care of people with COPD.


Eligibility Criteria:
Inclusion Criteria:

* Current or former smokers with a diagnosis of COPD
* Having impaired lung function as measured by spirometry

Exclusion Criteria:

* History of asthma or nasal symptoms caused by hayfever
* No telephone
* Inability to record symptoms in an electronic diary (PDA)
Effects of Transcranial Direct Current Stimulation on Fine Motor Skills in Parkinson's Disease: a Pilot Study

The purpose of this pilot study is to determine the effect of transcranial direct current stimulation (tDCS) on brain activity and fine motor skills in patients with Parkinson's disease compared to healthy controls.

The pilot study will involve a double-blind, sham controlled cross-over design where participants will receive anodal and sham tDCS stimulation in a randomized order. Differences in brain activity and fine motor skill performance between groups and after tDCS stimulation will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with idiopathic PD, according to the UK Brain Bank criteria
* Hoehn and Yahr (H\&Y) stage II in the 'on'-phase of the medication cycle
* Right dominant PD

Exclusion Criteria:

* Cognitive impairment (MMSE \< 23)
* Visuo-spatial deficits (measured by the Rey-Osterrieth Complex Figure (ROCF) test)
* Left-handedness (evaluated by the Edinburgh Handedness scale)
* Depression
* Pregnancy
* Alcohol abuse
* Aneurysm clips
* Pacemaker
* Neurostimulator
* Implemented defibrillator
* Magnetically activated implant or device
* Implemented pump
* Spinal cord simulator
* Implemented hearing aid
* Artificial or prosthetic limb
* Metal parts in the body
* Any external or internal metal
* Artificial heart valve
* Other implants
* History of brain surgery
* Migraine
* Family history of Epilepsy
* Other contra-indications for tDCS and Transcranial Magnetic Stimulation (TMS)
* Other neurological, psychiatric or interfering upper limb problems
A Study to Examine the Pharmacokinetics, Safety and Tolerability of Multiple Oral Doses of TMC435 in Healthy Chinese Participants

The purpose of this study is to determine the pharmacokinetics (what the body does to a medication) of TMC435 after multiple oral doses of 100 and 150 mg TMC435 once daily for 7 days in healthy Chinese participants.

This is an open-label (both \[participants and investigator\] know what treatment participants will receive) and randomized (study medication is assigned by chance) study. The study consists of 3 phases: a screening phase (within 21 days prior to administration of study medication), a treatment phase (from day -1 \[1 days before the administration of study medication\] to Day 10 including pharmacokinetics sample collection), and follow-up phase (up to 16 days after the last dose of study medication or after dropout \[other than withdrawal of consent\]). Approximately 32 healthy participants will be equally divided into 2 groups (Group 1 and Group 2) to receive TMC435 for 7 days. Safety will be evaluated by the assessment of adverse events, clinical laboratory tests, vital signs, and physical examination which will be monitored at various timepoints throughout the study. The total duration of study participation for each participant will be approximately 47 days.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Chinese participants on the basis of physical examination, medical history, vital signs, 12-lead electrocardiogram, and clinical laboratory tests performed at screening
* Must be non-smoking for at least 3 months prior to screening as confirmed by a urine cotinine test
* A Body Mass Index (BMI) of 18.0 to 30.0 kg/square meter, extremes included (BMI is calculated as BMI = body weight in kg divided by the square of height in meters)
* Participants must agree to use one of the contraception methods defined in the protocol

Exclusion Criteria:

* Positive human immunodeficiency virus - type 1 and 2; syphilis; hepatitis A, B or C infection at screening
* History or presence of liver or renal clearance insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances
* History or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic medicines use
* Any history of significant skin disease such as but not limited to, rash or eruptions, allergies, dermatitis, eczema (inflammation of the skin), psoriasis (an inflammatory skin disease), or urticarial (a raised and itchy rash that appears on the skin)
* Female participants who are breastfeeding at screening
Therapeutic Vaccine Based on aDC1 Dendritic Cells for the Control of Viremia After ATI in HIV Infected Individuals

The goal of this interventional study is to validate the strategy of adjuvant therapy with dendritic cells in HIV infection in chronically infected individuals. The main questions it aims to answer are related to the safety and tolerance of the intervention and the virological and immunological impact of immunotherapy with aDC1 in HIV-infected individuals. The study will include 30 diagnosed HIV-infected patients, using antiretroviral therapy, who will be immunized with aDC1 or placebo according to the arms of this study: G1) placebo; G2) aDC1immunization; G3) aDC1 immunization with analytical treatment interruption of ART.

Dendritic cell based immunotherapy is a potential tool to stimulate a specific immune response, as a complementary treatment for HIV-infected individuals using ART. Polarizing DCs are capable to produce high levels of IL-12p70 and induce a strong cytotoxic response that is very useful in viral infections. In this context, we propose to study aDC1 pulsed with relevant HIV peptides for treatment of HIV infected individuals.

The study will include 30 diagnosed HIV-infected patients, using antiretroviral therapy, who will be immunized with aDC1 or placebo according to the arms of this study: G1) placebo; G2) aDC1immunization; G3) aDC1 immunization with analytical treatment interruption of ART. Autologous PBMCs will be collected for baseline parameters and vaccine will be inoculated in 3 doses (with 4 week interval). Three weeks after 3th vaccine inoculation, patients will be followed for 6 months and blood and biopsis samples will be collected for different parameters measurement as immune activation, immunogenicity, humoral response, mucosal cellular immunity and virologic profile and viral reservoir analysis.

Eligibility Criteria:
Inclusion Criteria:

* HIV infection confirmed according to the criteria of the Department of Chronic Diseases and Sexually Transmitted Infections of the Brazilian Health Ministry;
* Absence of the use of antineoplastic or corticosteroid therapies for a minimum period of six months prior to study entry;
* Absence of comorbidities considered uncontrolled by researchers;
* Viral load ≤ 40 copies/mL, stable (i.e., no \> 0.5 log) in the six months prior to the start of the study;
* Blood count of CD4 T lymphocytes ≥ 500 cells/μL, stable (i.e., \>25%) in the six months prior to the start of the study;
* Informed consent

Exclusion Criteria:

* Individuals without adequate venous access to the blood collection and apheresis procedure;
* Use of drugs or alcohol in a way that interferes with patients' ability to follow the study requirements;
* Pregnancy, breastfeeding or interest in becoming pregnant during the study period;
* Presence of any other condition that, in the evaluation of researchers is able to promote alteration of the immune system, as well as any disorders that could affect understanding in the process of informed consent.
Feasibility of Translumenal Endoscopic Omental Patch Closure of Perforated Viscus

This study is being done to see if a new approach to repair perforated ulcers in the stomach (holes in the stomach) or the first part of the intestine is possible. Traditionally, either open operations (large single incision) or laparoscopic operations (multiple small camera-guided incisions) have been used to repair perforated ulcers. Over the last ten years, some surgeons have used endoscopic equipment to assist them with performing the procedure. It is unknown if perforated ulcer repair can be done using an endoscope as the main instrument (a flexible tube with a video camera inserted into the stomach through your esophagus) to "patch" or plug the perforation. We will patch the perforation using a standard method which uses tissue from outside the stomach. A laparoscopic camera will also be used to assist our view. This study is intended to be a feasibility study to demonstrate the endoscopic technique can be safely performed

Hypothesis: The primary outcome is successful completion of the procedure.

Perforation is the most dangerous complication of gastroduodenal ulcer disease. It accounts for more than 70% of deaths associated with peptic ulcer disease. In addition to age and concomitant disease, intervention related complications are statistically significant predictors of death after hospital stay. Age, time to presentation and comorbidities are not factors that can be influenced. If it would be possible to reduce the impact of procedure related complications or the "second hit", that may lead to decreased morbidity and mortality.

This will be a pilot clinical study to evaluate the safety and feasibility of endoscopic translumenal omental patch closure. Patients with the clinical diagnosis of a perforated viscus who are scheduled to undergo surgical exploration will be recruited. Endoscopic translumenal omental patch will be attempted first if the patient has no contraindication. Should this prove unsuccessful, the surgical team will proceed with conversion to laparoscopic or open standard surgical therapy as indicated.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with clinical diagnosis of a perforated viscus who are scheduled to undergo surgical intervention
* Surgical candidate for endoscopic, laparoscopic, or open procedure
* Age \> 21
* Informed written consent

Exclusion Criteria:

* Prior gastric or duodenal surgery
* Prior total abdominal colectomy or transverse colectomy
* Prior omentectomy or omental flaps
* Known perforation site other than stomach or duodenum
* Patients with contra-indications for laparoscopy
* Patients with contraindications for endoscopy
* Upper gastrointestinal anatomy that would preclude endoscopic therapy
* Coagulopathy or thrombocytopenia
* Pregnant patients
* Patients \<21 years of age
* Prisoners
* Patients found at surgery to have disease processes other than perforated peptic ulcer disease will be asked for permission to record their data for comparison
Change of Gastric Fluid Volume After Oral Hydration in Fasted Objects

This study aims to evaluate the permissive amount and time limit of clear fluid intake for preoperative fasting.

Observations of two kinds of liquids (water, carbohydrate drink) in five different volumes (10ml, 50ml, 100ml, 200ml, 400ml) will be performed on different days. Subjects prepare for investigation, a 4-hour fast excluding water, followed by 1 hour of fasting including water, and then 10 ml or 50 ml or 100 ml or 200 ml or 400 ml of clear water in a pre-randomized order and then the cross-sectional area of the stomach antrum will be measured via ultrasound every 10-minute until the contents are no longer visible. The same observation will be performed with a noNPO drink beverage containing 50 g of carbohydrate, again in a randomized order, and then 10 ml, 50 ml, 100 ml, 200 ml or 400 ml, and then every 10 minutes until the contents are no longer visible. One dose of one type of fluid will be ingested and observed at each visit, and repeated visits will be made until observations for all doses have been completed (10 visits in total, with 5 doses of water and carbohydrate drinks). During measurement, the stomach will be checked for contents supine position and then turned to the right decubitus.

Eligibility Criteria:
Inclusion Criteria:

* age ≥19 yrs

Exclusion Criteria:

* history of abdominal surgery
The Effect of Patient Education on Fatigue and Quality of Life in Inflammatory Bowel Disease

Introduction: Fatigue is a serious symptom that is seen in a significant portion of IBD patients and negatively affects the patient's quality of life. The aim of this study is to evaluate the effect of patient education on the management of fatigue, which is common in inflammatory bowel diseases.

Material and methods: This study will be planned with nonrandomized control group, pretest-posttest design. It is planned that the sample group will consist of at least 84 patients, 42 of which are in the intervention group and 42 in the control group. The patients in the intervention group will be evaluated in terms of fatigue and factors that may affect it, and an individualized education program will be offered according to the needs of the patient.For the patients in the control group, only the scales used in data collection will be filled, and no education will be planned. One month after the first interviews, both groups will fill in the scales again.

The aim of this study is to evaluate the effect of patient education on the management of fatigue, which is common in inflammatory bowel diseases.This study will be conducted in IBD outpatient clinic in Eskisehir Osmangazi University Hospital. This study will be planned with a nonrandomized control group, pretest-posttest design. Patients who meet the criteria will be assigned to the intervention or control group. It is planned that the sample group will consist of at least 84 patients, 42 of which are in the intervention group and 42 in the control group. The patients in the intervention group will be evaluated in terms of fatigue and factors that may affect it, and an individualized education program will be offered according to the needs of the patient. All patients will be assessed at baseline by use of following tools: Patient Information Form, Crohn's Disease Harvey-Bradshaw Activity Index (HBI), Simple Colitis Clinical Activity Index (SCCAI), Inflammatory Bowel Diseases Fatigue (IBD-F) Scale, Inflammatory Bowel Diseases Quality of Life Assessment Questionnaire. Patients in the intervention group will be applied one-session individualized patient education by the researcher. The control group will be applied usual care. Two groups will be compared at baseline and at the 1st month after the intervention with the same scales

Eligibility Criteria:
Inclusion Criteria:

* Disease in remission
* Diagnosis of inflammatory bowel disease with endoscopic procedures
* Being over 18 years old,
* Patient's volunteering to participate in the research

Exclusion Criteria:

* Having a psychiatric illness,
* Having a diagnosis of chronic fatigue syndrome,
* Difficulty in communicating (speech, perception, understanding problem),
* Having an advanced chronic disease
Effect of rFVIIa on Peri-operative Blood Loss in Patients Undergoing Major Burn

The purpose of the study is to see if a medication (Recombinant Coagulation Factor VIIa or NovoSeven), normally used to stop bleeding in persons with a bleeding disorder, will lower the amount of blood lost during burn surgery.

To identify the clinical use for Factor VIIa in the operating room to reduce blood loss and blood transfusion , determine the Recombinant Factor VIIa (rFVIIa) pharmacokinetics in burned patients, determine if fFVIIa should be used to reduce peri-operative blood loss in patients undergoing excision greater than or equal to 20 percent of the total body surface area, determine the efficacy of the drug in burned patients undergoing excision of burn wounds.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Burn wounds
* 18-65 years of age
* Scheduled excision of burn wound of at least 20 percent TBSA

Exclusion Criteria:

* Age greater than 65 years
* History of blood coagulation disorders
* Taking anti-coagulation medication
* Contraindication for heparin therapy
* Pregnant or nursing females
* Unstable angina
* MI within the last 6 months
* Recent of diagnosis of DVT, stroke within the last 6 months
* Renal failure requiring dialysis or creatinine clearance less than 25 ml/min
* Religious prohibition to blood transfusion
* Have received rFVIIa during current hospitalization
* Previous enrollment in this study
ANKLE TRAUMA Diagnostic Value of Ultrasound Compared to Standard Radiography in the Detection of Fractures

To investigate the diagnostic value of ultrasound performed by a lay experimenter compared to standard radiographic imaging (or standard x-ray) in the detection of fractures in patients with closed acute ankle trauma and positive Ottawa ankle rules

Selection of patients is according to the criteria detailed below. If the patient is deemed eligible for the study, he will be asked to read and sign the informed consent. Besides standard history taking, physical examination and radiographic imaging, a standardized ultrasound examination of the ankle joint will be performed by a lay experimenter.

Care will be provided by the attending physician and, according to "standard of care", treatment decisions will be based on history taking, physical examination and conventional ankle x-ray series. Sonographic results will not be used for this purpose. All ankle x-ray series will be reviewed by a senior resident radiologist.

Eligibility Criteria:
Inclusion Criteria:

Any adult patient with acute ankle trauma

+ one or more criteria of the Ottawa ankle rules :

* Inability to walk 4 steps immediately after the trauma or in the emergency room,
* pain at the level of the internal or external malleolus (the distal 6 cm) or the base of the 5th metatarsal bone.

Exclusion Criteria:

* Any patient under the age of 18 years
* Any patient unable to sign the informed consent
* Skin lesions contraindicating sonography (e.g. open fracture wound, ... )
* An unstable patient whose inclusion in the study would delay vital treatment
Effects of Systemic NO-Inhibition on Renal Hemodynamics in Patiens With Polycystic Kidney Disease and Chronic Glomerulonephritis

The study tests the hypothesis that systemic and renal nitric oxide availability is changed in polycystic kidney disease and chronic glomerulonephritis.

In a randomized, placebo controlled design, the effects of systemic treatment with monomethyl-L-arginine are studied on:

1. renal hemodynamics
2. renal sodium excretion and lithium clearance
3. blood pressure and heart rate
4. plasma levels of vasoactive hormones

in patients with adult polycystic kidney disease and chronic glomerulonephrits. The results are compared with a group of healthy control subjects

Eligibility Criteria:
Inclusion Criteria:

Healthy controls

* Age 20 to 60 years
* Both men and women
* Weight below 100 kg
* Normal clinical examination and laboratory screening
* Fertile women only if using contraception
* Informed consent according to the regulations of the local etics committee

Chronic glomerulonephritis

* Biopsy veryfied chronic glomerulonephritis
* P-creatinine \< 250 µmol/L
* Weight below 100 kg
* Age 20 to 60 years
* Both men and women
* Informed consent according to the regulations of the local etics committee

Adult polycystic kidney disease (APKD)

* Diagnosis of APKD by family history and renal ultrasound or renal angiography
* P-creatinine \< 250 µmol/L
* Weight below 100 kg
* Age 20 to 60 years
* Both men and women
* Informed consent according to the regulations of the local etics committee

Exclusion Criteria:

Healthy controls

* History or clinical evidence of diseases of the heart and blood vessels, kidneys, liver and pancreas, endocrine organs, lungs, neoplastic disease, myocardial infarction or cerebrovascular insult as evaluated by clinical examination and laboratory screening
* Current medication
* Drugs or alcohol abuse
* Pregnancy
* Previously within one year received more than 0.2 mSV radioactive treatment or diagnostic substances
* Donation of blood less than 1 month before the experiments

Chronic glomerulonephritis

* Apart from chronic glomerulonephritis and hypertension no history of diseases of the heart and blood vessels, liver and pancreas, endocrine organs, lungs, myocardial infarction, cerebrovascular insult or neoplastic disease.
* Patients with nephrotic syndrome or secondary glomerulonephritis
* Current medication other than antihypertensive therapy
* Drugs or alcohol abuse
* Pregnancy
* Previously within one year received more than 0.2 mSV radioactive treatment or diagnostic substances

Adult polycystic kidney disease

* Apart from APKD and hypertension no history of diseases of the heart and blood vessels, liver and pancreas, endocrine organs, lungs, myocardial infarction, cerebrovascular insult or neoplastic disease.
* Current medication other than antihypertensive therapy
* Drugs or alcohol abuse
* Pregnancy
* Previously within one year received more than 0.2 mSV radioactive treatment or diagnostic substances