cyrilzakka/clinical-trials huggingface dataset:
The Treatment of Bartholin´s Cyst or Abscess With Silver Nitrate

Silver nitrate treatment of Bartholin's cyst or abscess will be compared to marsupialization treatment.

It is expected that silver nitrate treatment is effective, simple, inexpensive and the least anaesthetic requiring procedure, which can easily be carried out in the outpatient setting.

Background and objective:

Bartholin gland cysts and abscesses are common problems in women of reproductive age. The traditional treatment of Bartholin´s cyst or abscess is marsupialization, which has disadvantages, such as pain of long duration, scarring, risk of general anaesthesia and risk of recurrence. In the present study we use silver nitrate in the treatment of Bartholin's cyst or abscess and compare to marsupialization. We expect lower healing time, lower recurrence rate and less pain with the silver nitrate treatment.

Methods and materials:

30 patients with Bartholin´s cyst or abscess will be investigated. It is prospective randomized study. The silver nitrate treatment is performed under local anaesthesia on an outpatient basis. A simple vertical incision 1 cm in length is made in the vaginal mucosa and the underlying cyst or abscess wall. A crystalloid silver nitrate stick of 5 mm in diameter and 5 mm in length is inserted into the cyst or abscess cavity.

The standard marsupialization treatment is performed under general anaesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Women with a age of 18-60 years
* Should read and understand Danish
* All women inclusive pregnant should have a Bartholins cyst or abscess

Exclusion Criteria:

* Subject who cannot give written informed consent
The Effect of Sihogayonggolmoryeo-tang on the Anxiety of Hwa-byung

In this randomized, double blinded, Placebo-control Trial, the investigators planned to give Sihogayonggolmoryeo-tang extract or controlled medication on the Anxiety of Hwa-byung.


Eligibility Criteria:
Inclusion Criteria:

* male or female aged 20-65
* subjects who meet structured interview criteria for Hwa-Byung Diagnosis
* subjects who have axiety (more than 17 score in HAMA)

Exclusion Criteria:

* duration of illness less than 6 months
* current or past history of delusions, hallucination
* past history of at least one manic episode, hypomanic episode, or mixed episode
* current or past history of alcohol abuse or alcohol dependence history
* taking substances(e.g. steroids) which might affect symptoms
* medical conditions(e.g. hyperthyroidism, hypothyroidism, heart disease) that might affect symptoms
* current with hepatoma, hepatic cirrhosis, chronic renal failure, congestive heart failure
* pregnancy, lactation, women not using medically accepted means of birth control
* considered not apt to carry out clinical trial
Effects of Core Stabilization Exercise Plus Kinesio Taping in Woman With Fibromyalgia

This study aimed to compare the effectiveness of a 6-week core stabilization exercise (CSE) program with and without kinesio taping on pain, fatigue, health status, quality of life, sleep quality and depression in woman with fibromyalgia.

Participants were allocated into two groups as CSE and CSE plus kinesio taping group. Pain, fatigue, health status, quality of life, sleep quality and depression were assessed at the baseline and after 6-weeks treatment.

A 6-weeks prospective randomized controlled trial examined the effects of core stabilization exercise (CSE) plus kinesio taping (KT) compared to CSE alone on pain, fatigue, health status, quality of life, sleep quality and depression in woman with FM. The trial was approved by the Ethics committee of Ankara Yildirim Beyazit University (Approval time and number: 17.01.2018-14). The study was performed in compliance with Helsinki Declaration where applicable. The patient's recruitment started in February 2018. The patients diagnosed with Fibromyalgia according to the criteria of the 1990 American College of Rheumatology participated in the study. Prior to the treatment and after 6-weeks treatment, participants' pain level, fatigue, health status, quality of life (QoL), psychological status and sleep quality were assessed. Assessments were realized by face-to-face interview method.Patients who participated in CSE group performed CSE program alone, whereas patients in CSE+KT group performed CSE program with KT application. The treatment was carried out 2 days a week for 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Fibromyalgia, being woman, having moderate or severe pain according to Visual Analog Scale, 18-65 years of age and being volunteer for the study

Exclusion Criteria:

* having neurologic, infectious, and endocrine diseases, malignancy, being pregnant, severe psychological disorders, any changing of medications during treatment, being allergic to taping, any condition interfering with exercise (advanced cardiac, respiratory or musculoskeletal problems), and intervention including exercise program or physical therapy in the last 6 months.
To Determine Blood Pressure Interaction Between TC-5214 and Anti-Hypertensive Medications (Calcium Channel Blockers, Beta Blockers, and ACE Inhibitors) in Patients With Chronic Hypertension

This is a two part study. Part 1 will determine determine if administration of TC-5214 has an effect on sitting blood pressure in patients with chronic hypertension.

Part 2 will determine any possible interactions between TC-5214 and Anti-Hypertensive Medications (Calcium Channel Blockers, Beta Blockers, and ACE Inhibitors).

A Phase I Randomised, Placebo-Controlled, Double-Blind Study in Hypertensive Patients of the Blood Pressure Interaction between TC-5214 and Anti-Hypertensive Medications (Calcium Channel Blockers, Beta Blockers, and ACE Inhibitors)

Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures
* Male or female patients with chronic, stable hypertension treated for at least 1 month before screening with a calcium channel blocker, a beta blocker, or an ACE inhibitor, either as the only anti-hypertensive medication or concurrently with a diuretic. The patients should have no change in their current anti hypertensive treatment for at least 1 month before dosing
* Patients in Part 1 should have an SBP of ≤140 mmHg at screening and ≤160 mmHg at Visit 1a and pre-dose on Day 1
* Patients in Part 2 should have an SBP of ≤160 mmHg at screening Visit 1 and pre dose on Day 1. Systolic blood pressure and DBP should not vary by more than 8 mmHg and 5 mmHg, respectively, in the pre-dose period (screening, Visit 1a, and pre-dose on Day 1)
* Age 18 to 65 years (inclusive)

Exclusion Criteria:

* Other than having chronic hypertension, the history of any clinically significant medical, neurologic, or psychiatric disease or disorder which, in the opinion of the Investigator and/or the Sponsor, may either put the patient at risk because of participation in the study or influence the results, or the patient's ability to participate in the study. Patients with dyslipidaemia (diet controlled or treated with a statin) and/or metabolic syndrome (diet controlled or treated with metformin) may be entered into the study
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the investigational product
* Patients with a pre-treatment SBP (if known) of \>180 mmHg or a history of accelerated or malignant hypertension based on grade III (hypertensive haemorrhages and/or cotton wool spots) or grade IV (hypertensive papilloedema) retinopathy at any time
* History or presence of gastrointestinal (including irritable bowel disease), hepatic, or renal disease (creatinine clearance of ≤50 mL/minute calculated using the Cockcroft Gault equation) or any other condition known to interfere with the ADME of the investigational product.
* Patients with a history of surgery on the gastrointestinal tract (not including appendectomy or cholecystectomy) should also be excluded
* Any significant ECG abnormality including QTcF prolongation (\>450 ms) or significant arrhythmias, or junctional rhythms
Prevalence Study of Sleep Apnea in Women With Preeclampsia

Hypothesis: The prevalence of sleep apnea is greater in pregnant women with preeclampsia than in pregnant women without preeclampsia.The presence of sleep apnea will be associated with poor blood pressure control, worsening blood pressure during sleep and evidence of fetal distress. The usual treatment for sleep apnea is to have the patient breathe pressurized air through a mask. This is called continuous positive airway pressure (CPAP). In preeclamptic women with sleep apnea, use of CPAP will result in improved blood pressure control and reduced fetal distress.

Sleep apnea is common in the adult population. In middle aged men, the presence of sleep apnea has been correlated with hypertension, cardiovascular disease and mood disorders. Sleep apnea is not as well studied in women and even less is known about sleep apnea in pregnant women. However, preliminary evidence suggests that the incidence is quite high, particularly in women with severe preeclampsia. We propose to perform sleep studies on 30 women with preeclampsia and 30 healthy pregnant controls. In addition to the usual sleep study monitoring, we will also measure beat-to-beat blood pressure through non-invasive monitoring and we will do continuous electronic fetal monitoring. Women found to have sleep apnea will have a repeat study in which CPAP therapy is applied, and be provided CPAP therapy for nightly use at home.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women \>18 years of age

Exclusion Criteria:

* significant medical conditions that would be expected to affect maternal- fetal outcomes
* need for admission to hospital, so that it transfer to the sleep would compromise maternal-fetal safety
Breath Condensate Study in Patients With Cystic Fibrosis.

There is an urgent need for a noninvasive method to diagnose bronchial infections and exacerbations in patients with Cystic Fibrosis (CF). The current method to diagnosed infections involves either collecting a sputum sample or obtaining a bronchoalveolar lavage (BAL). However, some patients cannot produce sputum. At the same time the decision of when a patient has an exacerbation continues to be very subjective. In this exploratory study, we propose a new, noninvasive method to diagnose bronchial infections and to evaluate possible markers of inflammation that can assist in a noninvasive way in the determination of exacerbations.

We hypothesize that it is possible to recover microbial products causing infections in Exhaled Breath Condensate (EBC) samples as well as to measure markers of inflammation like Interleukin (IL)-8, Leukotriene B4 (LTB4), Interleukin IL-6, Interleukin IL-1B, Tumor Necrosis Factor alpha, as well as proteases like neutrophil elastase, matrix metalloproteinase 2 and 9 and antiproteases like secretory leukoprotease inhibitor (SLPI), alpha one antitrypsin and tissue inhibitor of metalloproteinase-1 (TIMP-1). As a way to compare our findings to systemic inflammation we will also measure C-reactive protein in serum.

20 patients with cystic fibrosis who have chronic bronchial infection and 20 controls will be recruited. Their exhaled breath condensate and sputum samples will be collected and analyzed for the presence of bacteria through traditional, molecular and nuclear acid amplification methods as well as Pyrosequencing analysis. We will also measure the above markers of inflammation and follow the CF patients for the following year so we can continue to collect exhaled breath condensate when they have an exacerbation and are admitted to the hospital as well as after treatment for the exacerbation. We will correlate these markers with patient's clinical features including pulmonary function test, Body max index, CF pathogens, and CF genotype. If our hypothesis turns out to be true it will open up a possibility for a new noninvasive diagnostic and follow up method that will benefit cystic fibrosis patients.

2. Hypothesis \& Specific Aims:

A. Microbial products can be recovered from exhaled breath condensate. B. That these microbial products recovered from exhaled breath correlate with that recovered from sputum C. Markers of inflammation can be recovered from exhale breath condensate.

Eligibility Criteria:
Inclusion Criteria:

Any patient with Cystic Fibrosis (CF) in the age range 18-65 years who is known to be chronically infected in their respiratory tract will be eligible as cases. Any other patient or healthy subject in the age range 18-65 years who is not infected with Pseudomonas in their respiratory tract will be eligible as controls.

Exclusion Criteria:

Any study subject, who cannot co-operate with the study, cannot co-ordinate breathing or cannot breathe through a mouthpiece.
Web-based Physical Activity Program

The specific aims of the proposed study are:

* 1. To determine if web-based Motivational Interviewing (MI) is effective, compared to an informational web-based comparison group, in enhancing physical activity (PA) participation; and
* 2. To assess the mechanisms by which web-based MI enhances PA through changes in targeted cognitive mediators.

The specific hypotheses of the study include that:

* Hypothesis 1: Web-based MI will increase PA;
* Hypothesis 2: Web-based MI will lead to stage progression in the direction of increased readiness to participate in PA;
* Hypothesis 3: Web-based MI will influence theoretically identified cognitive variables;
* Hypothesis 4: Cognitive variables will mediate increases in PA participation.

Increasing physical activity (PA) is a public health priority. There is preliminary support for application of Motivational Interviewing (MI) for physical activity (PA), web-applications for PA promotion, web-based MI for behavior change, and finally web-based MI for PA. Based on collective findings in these areas of inquiry, it is necessary to investigate the efficacy of MI as a method that lends readily to practical applications for PA promotion. The current study seeks to investigate whether web-based MI can be applied in an adult population to enhance PA participation using a physician referral scheme. Additionally, mechanisms of behavior change are considered in order to inform future research and intervention.

Eligibility Criteria:
Inclusion Criteria:

* Adults referred through primary care due to insufficient physical activity standards based on Centers for Disease Control (CDC) guidelines for aerobic activity.
* Must have internet access and e-mail.
* Cleared by physician for physical activity participation.

Exclusion Criteria:

* Greater than 10,000 steps per day on average based on baseline pedometer screening over the course of 7 days.
Interest of Day Hospital Care for Patients With Chronic Regional Pain Syndrome Referred to the Chronic Pain Unit for the First Time

Chronic Regional Pain Syndrome (CRPS) is a chronic disabling disease. Patients present a variable picture associating pain localized to an articular or peri-articular region, motor and vasomotor disorders and trophic disorders.

Its pathophysiology, still poorly understood to this day, results from local inflammatory phenomena complicated by peripheral sensitization and central spinal and cerebral sensitization.

The diagnosis is made difficult by the fluctuating nature of the symptoms and the absence of specific complementary examination.

The treatment of CRPS is symptomatic and requires multidisciplinary care. CRPS is responsible for an alteration in the patient's quality of life. This pathology has a global impact because it affects not only the biomedical sphere but also the socio-family, professional and psychological spheres.

The investigators hypothesize that multidisciplinary intervention in the Day Hospital would improve the quality of life of patients with CRPS. The investigators also think that the passage in Day Hospital would make it possible to improve the pains, the functionality of the affected limb as well as the satisfaction of the patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient volunteers over 18 years of age
* Diagnosis of CRPS according to the Budapest criteria
* Referred to pain assessment and treatment center

Exclusion Criteria:

* Patients unable to express their wishes or understand the protocol
* Diagnosis of CRPS not meeting Budapest criteria
* Patients previously seen at pain assessment and treatment center for the care of CRPS
Treatment of Advanced Gastrointestinal Cancer in a Phase I/II Trial With Modified Autologous MSC_apceth_101

To evaluate the safety and tolerability of MSC_apceth_101.


Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced or recurrent or metastatic gastrointestinal adenocarcinoma.
* Premature or scheduled termination of standard therapy
* Progressive disease as clinically assessed by the investigator
* Max. tumour lesion ≤ 5 cm
* Adequate organ function
* Ability of patient to understand character and individual consequences of clinical trial
* Age ≥ 18 years
* Written informed consent must be available before any study specific procedure is performed

Exclusion Criteria:

* Patients with severe heart diseases
* Clinical significant ischemic disease during the last 4 weeks before Visit 1
* Severe lung disease
* Symptomatic peritoneal carcinomatosis
* Symptomatic pleural or pericardial effusion
* Serious uncontrolled acute infections less than 3 weeks before Visit 1
* Known dependency on alcohol or other drugs
* Patients requiring corticoids in doses above the Cushing threshold
* Known liver fibrosis or liver cirrhosis
* Any concomitant severe disease which could compromise the objectives of this study in the judgment of the investigator
* Female patient who is pregnant or breast feeding
* Participation in another clinical trial or observation period, respectively, during the last 4 weeks prior to the first IMP dose
A Study of Tarceva (Erlotinib) to Compare Two Different Doses in in Currently Smoking Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (CURRENTS)

This prospective, double-blind, randomized study will evaluate the safety and efficacy of two dose levels of erlotinib \[Tarceva\] on progression-free survival, response and disease control rates and overall survival in patients with advanced or metastatic non-small cell lung cancer (NSCLC) after failure of first-line platinum-based chemotherapy. Patients must be current smokers and not intending to stop smoking during the study. Patients will be randomized to receive either 150 mg or 300 mg of study drug as single daily oral doses. Treatment will continue until disease progression.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged ≥18 years
* inoperable, locally advanced (stage IIIB/IV) with supraclavicular lymph node metastases or malignant pleural or pericardial effusion) or metastatic (stage IV) non-small cell lung cancer (NSCLC)
* Disease must be characterized according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria
* Patients have received one prior platinum-based chemotherapy regimen for advanced NSCLC, but must have recovered from any treatment-related toxicity
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Life expectancy ≥12 weeks
* Current cigarette smoker (having smoked \>100 cigarettes in entire lifetime and currently smoking on average ≥1 cigarette per day), not intending to stop during the study

Exclusion Criteria:

* Prior antibody or small molecule therapy against Epidermal growth factor receptor (EGFR)
* Radiotherapy within 28 days prior to enrollment
* Received more than one line of chemotherapy for locally advanced/metastatic NSCLC (first-line maintenance chemotherapy after first-line platinum-based chemotherapy is allowed)
Kor PCI - CAD Patients Treated With PCI: Analysis of the Korean Nationwide Health Insurance Database

Current Status and Prognosis of Coronary artery disease patients treated with coronary intervention - Analysis of the Korean Nationwide Health Insurance Database

This is a retrospective study and is conducted for all patients who received percutaneous coronary intervention among cohorts registered with the National Health Insurance Service.

Primary outcome is all cause of mortality. Secondary outcomes are cardiovascular death, ischemic stroke, cerebral hemorrhage, admission due to gastrointestinal bleeding, and admission due to major bleedings.

Eligibility Criteria:
Inclusion Criteria:

* All coronary artery disease patients wih Korean NHIS (National Health Insurance Service)-listed PCI

Exclusion Criteria:

* non-specified
Mild Versus Moderate Therapeutic Hypothermia in Out-of-hospital Cardiac Arrest Patients

This trial is currently a single-center, randomized, double-blind investigator initiated prospective clinical trial initiated at the University of Ottawa Heart Institute (UOHI). The plan is to expand the trial shortly as a multi-center project. The patients for this study will be recruited amongst comatose survivors of out-of-hospital cardiac arrest (OHCA). The aim of this study is to determine whether neurologic outcomes at six months are improved with moderate (31 degrees Celsius) versus mild (34 degrees Celsius) therapeutic hypothermia (TH) following return of spontaneous circulation (ROSC) in patients suffering OHCA, with ROSC defined as the resumption of sustained perfusing cardiac activity.

The primary outcome will be the proportion of patients experiencing death or a poor neurologic outcome at six months after out of hospital cardiac arrest.


Eligibility Criteria:
Inclusion Criteria:

1. Out of hospital cardiac arrest patient
2. Return of spontaneous circulation
3. Glasgow Coma Score equal or lesser than 8.

Exclusion Criteria:

1. Patients residing in a Nursing Home or patients unable to reside independently,
2. Intracranial bleed responsible for the cardiac arrest,
3. Severe coagulopathy with clinical evidence of major bleeding,
4. Coma that is not attributable to cardiac arrest,
5. Pregnancy,
6. Life expectancy of \< one year due to any cause unrelated to the cardiac arrest,
7. Known coagulation disorder (i.e. INR \>2.0, platelets \<100,000 / mm3),
8. Participation in a study with another investigational device or drug \< four weeks,
9. The Endovascular cooling (ZOLL) device is not available.
Atrial Fibrillation Without Hemodynamic Instability in the Intensive Care Unit

Atrial fibrillation (AF) is an abnormal heart rhythm that is common among patients who are admitted to an intensive care unit (ICU) of a hospital. It is usually a transient occurrence that resolves as the patient recovers from their underlying condition. However, patients who develop AF can present with a very rapid heart rate that in some cases can put stress on the heart which can lead to life threatening heart attacks, low blood pressure or breathing problems. Not all patients with AF will have unstable heart function but those who have rapid heart rates can worsen quickly. The goals of treatment for AF with a rapid heart rate but no unstable heart function are two fold. Patients can be treated by controlling the heart rate and/or by attempting to convert the AF to a normal heart rhythm. The heart rate can be controlled by medication and the AF can be converted by either electrical cardioversion (an electric shock that jump-starts the heart) or medication. Currently it is unknown if the goal of treatment should be to simply control the heart rate and wait for the patient to spontaneously convert to a normal heart rhythm or convert the AF with medication for patients who only have the rapid heart rate.

The objective of this project is to conduct a pilot study to determine if it would be feasible to conduct a larger definitive trial that would answer the following question: Should the goal of treatment be to control the rapid heart rate or resolve the abnormal heart rhythm in patients with AF who have a rapid heart rate without unstable heart function.

see above

Eligibility Criteria:
Inclusion Criteria:

* new onset afib

Exclusion Criteria:

* hemodynamically unstable