cyrilzakka/clinical-trials huggingface dataset:
Acute Effects of a Flutter Device and Chest Wall Compression on Respiratory System Impedance in Bronchiectasis Patients

Bronchiectasis is characterized pathologically by the abnormal and permanent dilation of bronchi caused mainly by the perpetuation of inflammation and impaired clearance of secretions. Physical therapy is essential in the treatment of these patients, using its various techniques and devices. The aim of this study is to evaluate the impedance of the respiratory system, by impulse oscillometry, after breathing exercises with chest compression or flutter in patients with bronchiectasis, considering that there are no results in the literature on the effect of these techniques in the small airways of these patients.

Bronchiectasis patients and healthy subjects will be evaluated before and after a 30 minutes session of control, breathing exercises with flutter valve, that is a device that produces oscillation and positive pressure during the expiratory phase, or chest compression, that is a manual manoeuvre in the right and left sides of the lower chest, all of them in a sitting position. The main outcome will be obtained by impulse oscillometry, that is a method to access large and small airways, to evaluate the resistance (R), reactance (X), reactance area (AX) and resonant frequency (Fres) of respiratory system for the whole breath and for inspiratory and expiratory phase. Additionally, will be analysed the dyspnea using the Medical Research Council scale; acceptability and tolerability scale; pulse oxymetry; difficulty of expectoration score; and volume, adhesivity and purulence of sputum.

Eligibility Criteria:
Inclusion Criteria:

* aged between 30 and 80 years
* diagnosed with bronchiectasis not resulting from cystic fibrosis, defined by history and full clinical examination and confirmed by computed tomography.

Exclusion Criteria:

* Chest pain
* acute hemoptysis
* recent history rib fracture and pneumothorax
* respiratory infection in the last 4 weeks prior to study
* cystic fibrosis
* asthma
* fistula.
* chronic obstructive pulmonary disease
Paracervical Block Before Intrauterine Device (IUD) Insertion

The purpose of this study is to evaluate if a paracervical block containing 1% lidocaine administered prior to IUD insertion reduces insertion pain. The hypothesis is that women receiving paracervical analgesia will experience less pain during IUD insertion than those who do not receive such analgesia.


Eligibility Criteria:
Inclusion Criteria:

* Women age 18 -50 years
* A negative urine pregnancy test and clinically unlikely to be pregnant
* Seeking an intrauterine device for any indication
* Willing and able to sign an informed consent in English

Exclusion Criteria:

* History of a prior IUD successful insertion
* Previous failed insertion of an IUD
* Known copper allergy
* Known levonorgestrel allergy
* Known lidocaine allergy
* Current cervicitis
* Pelvic Inflammatory Disease (PID) within 3 months
* Pregnancy within six weeks prior to IUD insertion
* Uterine anomaly or distortion of the uterine cavity
* Use of any other pain medication within 6 hours prior to IUD insertion
* Use of misoprostol within 24 hours prior to IUD insertion
Pre-Sleep Creatine Enhances Anaerobic Power in Recreationally Active Females

This study is a randomized, double-blind, placebo-controlled trial designed to examine the effects of pre-sleep creatine monohydrate supplementation on anaerobic performance and muscle damage markers in recreationally active females. Participants will be randomly assigned to receive either 5 grams of creatine monohydrate or a placebo 30 minutes before sleep for seven consecutive days. Anaerobic performance will be assessed using the Wingate Anaerobic Test, evaluating peak and average power output and fatigue index. Blood samples will be collected before and after the supplementation period to analyze markers of muscle damage, including creatine kinase and lactate dehydrogenase. This study aims to provide insight into the efficacy of short-term, time-specific creatine supplementation for enhancing performance and recovery.


Eligibility Criteria:
Inclusion Criteria:

Female, aged 18 to 25 years

Recreationally active (engaging in structured resistance training 3-4 times per week for the past 6 months)

Regular menstrual cycles (used for scheduling purposes)

Able and willing to provide informed consent

Agreement to maintain normal diet and training routines throughout the study

Exclusion Criteria:

History of musculoskeletal injury affecting lower or upper limbs within the past 6 months

Known allergy or intolerance to creatine or maltodextrin

Use of performance-enhancing substances or supplements within the last 30 days

Use of recovery modalities such as massage, cryotherapy, or compression garments during the study period

Current use of anti-inflammatory medication

Pregnancy or breastfeeding

Inability to comply with study protocol or scheduled assessments
Decreasing Rates of Intraurethral Catheterization Postoperatively in Spine Surgery

Randomization (1:1) of male patients, over age 50, undergoing elective spine surgery to tamsulosin versus a placebo.

Postoperative urinary retention (POUR) is a common complication following certain surgical operations. While much is known about the innervation and neural regulation of bladder emptying and storage, the cause of urinary retention after surgery is not fully understood. Early research has indicated that a small dose of tamsulosin (Flomax®), a commonly used medication approved to treat urinary symptoms in men with benign prostatic hypertrophy, may reduce the incidence of POUR. Urinary retention is a prevalent issue in patients undergoing spinal surgery, leading to patient discomfort and prolonged length of stay. We hypothesize that the use of perioperative tamsulosin in patients undergoing spinal surgery will decrease the incidence of POUR.

The study is a prospective, double-blind, randomized, placebo-controlled trial. Subjects will be randomized 1:1 to receive either oral tamsulosin 0.4 mg or placebo, taken once each evening, beginning 5 days prior to surgery and continuing through the first postoperative day. The primary endpoint is met when the patient is able to spontaneously empty their bladder post-operatively, or needs to be catheterized with either a straight or indwelling urinary catheter for post-operative urinary retention, whichever occurs first.

Eligibility Criteria:
Inclusion Criteria

* Male patient age 50 - 85 years
* Undergoing elective spine surgery at least 5 days after enrollment
* Preop visit done at office practice

Exclusion Criteria:

* Currently on tamsulosin or other alpha-adrenergic blocking drug
* Allergy to tamsulosin
* Allergy to lactose
* Serious or life-threatening allergy to sulfa drugs
* Emergent procedure
* History of spinal trauma, spinal infection or spinal cord tumor
* Pre-existing indwelling urinary catheter
* History of orthostatic hypotension or current orthostatic hypotension
* History of prostate, urethral or bladder surgery
* Renal failure
* Non-English speaking
* Unable to provide informed consent
Diabetes-Obstructive Sleep Apnea Treatment Trial

Diabetes self-management is important to help adults with type 2 diabetes achieve glucose control. Obstructive sleep apnea often co-exists with type 2 diabetes and may act as a barrier to diabetes self-management and glucose control. We will examine if treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP), combined with diabetes education, results in improved diabetes self-management and glucose control.

While diabetes self-management has been improved and refined over the last 30 years, many persons with T2DM continue to have difficulty in achieving glycemic goals. Obstructive sleep apnea (OSA) has a high prevalence among adults with type 2 diabetes (T2DM) and is associated with excessive daytime sleepiness, impaired mood, decreased vigilance, and reduced functional outcomes. The degree that OSA affects diabetes self-management, a known determinant of glycemic control, remains unstudied.

The most effective treatment for OSA, continuous positive airway pressure (CPAP), results in improved self-reported daytime functioning. However, the effect of CPAP treatment on reception of diabetes education remains unknown. The underlying premise of the proposed study from this new investigator is that OSA hinders diabetes self-management in adults with T2DM.

Our goal is to improve understanding of the effect of OSA on diabetes self-management and to determine the efficacy of CPAP treatment in improving diabetes outcomes in adults treated with CPAP compared to those on sham-CPAP. Expanding our understanding of the effect of sleep disturbances on diabetes self-management may lead to improved guidelines for screening and treatment of OSA in the increasingly large portion of the population with diabetes

Eligibility Criteria:
Inclusion Criteria:

* Suboptimal glucose control (A1C ≥ 6.5%)
* Moderate-to-severe obstructive sleep apnea (apnea + hypopnea index \>= 10/hour)
* age 18 years and older

Exclusion Criteria:

* Poor glucose control (A1C \> 11)
* Type 1 or gestational diabetes
* Sleep duration \< 4 hrs
* Acute medical or surgical conditions or hospitalization ≤ 3 months
* Oxygen or bi-level PAP required
* Prior CPAP or persons in household with CPAP
* Employed in safety sensitive job
* Pregnant
Safety Study of LiRIS in Interstitial Cystitis (IC) Patients

The purpose of this study is primarily to evaluate the safety and tolerability of two dose levels of an investigational drug-delivery system (LiRIS) in patients who have moderate to severe symptoms of interstitial cystitis.

Approximately 20 female patients with interstitial cystitis will be enrolled in this study at multiple centers in Canada. LiRIS is being developed to provide drug therapy directly into the urinary bladder. LiRIS contains Lidocaine, a marketed drug (approved by Health Canada) which is commonly used for local (skin or oral)anaesthesia. LiRIS is designed to release a controlled amount of lidocaine while in the bladder over a 2 week period.

Two dose groups of approximately 10 patients per group will be enrolled into the study; the first group of patients will receive low dose LiRIS, and the second group will receive high dose LiRIS. All patients receive LiRIS treatment for 14 days, and clinic follow-up at 7 and 14 days after treatment. Additional telephone follow-up occurs at approximately 6 and 10 weeks after LiRIS treatment. The maximum duration of participation, including a screening period of up to 14 days, will be 104 days.

Eligibility Criteria:
Inclusion Criteria:

* Female patients ≥ 18 years of age
* If of child-bearing potential, agrees to use effective contraception defined by protocol
* Capable of understanding and completing symptom diaries and questionnaires as required in the study
* Diagnosed with IC, as defined by protocol criteria

Exclusion Criteria:

* Bladder or urethra anatomical feature that, in the opinion of the investigator, might prevent the safe placement, indwelling use, or removal of LiRIS
* History or presence of any medical condition that would interfere with ability to assess symptoms
* Pregnant or lactating patients
The Use of Portable Wireless Monitor in Patient Vital Sign Monitoring

This clinical investigation assesses the performance of PaMo patient monitor system (PaMo) and its wearable sensing devices that combines continuous IP, ECG and PPG in detecting developing respiratory depression episodes. PaMo patient monitor system consists of a wearable measurement unit worn on a patient, bedside mobile unit that receives the data from the wearable unit through Bluetooth Low Energy connection, visualises it, and can be relayed further to the central unit through WiFi network.

Monitoring of voluntary subjects undergoing major surgery requiring postoperative intensive care treatment with PaMo patient monitoring device that includes continuous ECG, respiration and PPG monitoring.

The monitoring device is connected during anaesthesia preparation before induction of general anaesthesia and monitoring is continued throughout the surgery and in the intensive care unit (ICU) for total of 24 hours. For reference data, GE Carescape B850 patient monitors are used continuously for oxygen saturation, ECG and respiration signals. The data are collected from the reference patient monitor using a S/5 collect software and a study computer. In addition, to obtain a gold standard reference for SpO2 with blood gas analyzer arterial samples are taken every two hours during anesthesia and in the ICU concurrently with the routine checkups. During the surgery, an arterial cannula collects continuous blood pressure data and can be used for taking blood samples. The data collected with PaMo device and reference monitor are analyzed in Tampere University by researchers and used in device, software and algorithm development.

User experience information and usability feedback are collected at the end of the study from the medical staff with an interview form.

The study does not include a control group. All subjects are using the devices in similar way and the parameters collected from the same individual using two different methods are compared.

Eligibility Criteria:
Inclusion Criteria:

* Age: minimum of 18 years
* Undergoing pancreatic or ENT tumour surgery
* Ability to give informed consent
* Volunteering to the study

Exclusion Criteria:

* Age under 18 years
* Insufficient knowledge in Finnish
* Cardiac pacemaker
* Inability to give informed consent
* Denial
Celecoxib for the Treatment of Non-muscle Invasive Bladder Cancer

The treatment of non-muscle invasive bladder cancer (NMIBC) is problematic given the variable natural history of the disease. Although contemporary treatment options are limited, new targets and new approaches are under investigation for preventing bladder cancer recurrence and progression. Among those, COX-2 is a promising target since plays an important role in urothelial carcinogenesis and iCOX-2 selective inhibitors, like celecoxib, effectively inhibit tumor development and growth and enhances survival, in bladder cancer in vitro and in vivo models.

Therefore, the investigators conducted a pilot study of celecoxib to prevent recurrence in patients with intermediate risk NMIBC.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven urothelial bladder cancer
* Intermediate risk NMIBC
* ECOG Performance Status ≤ 2 or Karnofsky Score ≥ 60%
* Imaging study excluding upper urinary tract TCC

Exclusion Criteria:

* Pregnant and lactating women;
* Advanced co-existing medical or psychiatric disorders;
* Positive history of gastro-intestinal disease (peptic ulcer, inflammatory disease), intestinal bleeding;
* History of allergy to sulfonamide drugs;
* Concomitant investigational medications.
Irinotecan and Docetaxel With or Without Cetuximab in Treating Patients With Metastatic Pancreatic Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with cetuximab may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying giving irinotecan and docetaxel together with cetuximab to see how well it works compared to irinotecan and docetaxel alone in treating patients with metastatic pancreatic cancer .

OBJECTIVES:

* Determine the efficacy of irinotecan and docetaxel with or without cetuximab, in terms of objective response rate, in patients with metastatic adenocarcinoma of the pancreas.
* Determine the time to progression and overall survival of patients treated with these regimens.
* Determine the proportion of patients with tumors that overexpress epidermal growth factor receptor.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

* Arm A: Patients receive docetaxel IV over 1 hour and irinotecan IV over 30 minutes weekly on days 1, 8, 15, and 22.
* Arm B: Patients receive docetaxel and irinotecan as in arm A. Patients also receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36.

Courses repeat in both arms every 6 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 1 year, and then periodically thereafter.

PROJECTED ACCRUAL: A total of 92 patients (46 per treatment arm)

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed metastatic adenocarcinoma of the pancreas
* Sufficient tumor tissue from fine needle aspiration, core biopsy, or open biopsy available for epidermal growth factor receptor testing
* At least 1 unidimensionally measurable primary or metastatic lesionge
* Age of 18 and over
* ECOG performance status 0-1
* Negative pregnancy test
* Fertile patients must use effective contraception
* Creatinine clearance \> 60 mL/min
* LVEF normal
* Absolute neutrophil count \> 1,500/mm\^3
* Platelet count \> 100,000/mm\^3
* Bilirubin ≤ upper limit of normal (ULN)\*
* SGOT or SGPT and alkaline phosphatase must meet the criteria for 1 of the following\*:

  * SGOT or SGPT ≤ 2.5 times ULN AND alkaline phosphatase ≤ ULN
  * SGOT or SGPT ≤ 1.5 times ULN AND alkaline phosphatase \> ULN but ≤ 2.5 times ULN
  * SGOT or SGPT ≤ ULN AND alkaline phosphatase \> 2.5 but ≤ 4 times ULN

NOTE: \*Percutaneous stenting or endoscopic retrograde cholangiopancreatography may be used to normalize liver function tests

Exclusion Criteria:

* History of uncontrolled arrhythmias
* History of congestive heart failure
* History of uncontrolled angina pectoris
* Prior chemotherapy
* Pre-existing neuropathy ≥ grade 2
* Prior hypersensitivity to polysorbate 80
* Pregnant or nursing
Airway Involvement In Inflammatory Bowel Disease

To estimate prevalence of subclinical airway injuries among IBD patients. To investigate relationship between activity of IBD and airways

Airway diseases are the most commonly described lung manifestations of inflammatory bowel disease (IBD). However, the similarities in disease pathogenesis and the sharing of important environmental risk factors and genetic susceptibility suggest that there is a complex interplay between IBD and airway diseases.Extraintestinal manifestations (EIM) commonly occur in inflammatory bowel diseases (IBD), with a prevalence rate between 21%-41% reported in various series. Crohn's disease (CD) presents with EIM more frequently than ulcerative colitis (UC). Pulmonary involvement complicating IBD was originally considered rare (with a frequency rate \< 1%), but the first case series published in 1976 assisted in better recognition, evaluation and description of IBD related respiratory disease. Pulmonary involvement is often asymptomatic and may be detected solely on the basis of abnormal screening tests. This review will focus on the involvement of the airways in the context of IBD. Although IBD related PM were originally considered rare, certain population-based studies have revealed significant interrelationships between the lungs and IBD. Bernstein and colleagues in a large population-based study in North America in 2005 reported that airway disorders in general (including asthma and bronchitis) were the most common extraintestinal manifestation in subjects with CD and the second most common in subjects with UC, with the prevalence of asthma in this population between 7%-8%. In another retrospective study from the opposite view, Birring reported that IBD was 4 times more prevalent among patients with airway diseases, particularly non-asthmatic patients with productive cough, than in the general population.

Eligibility Criteria:
Inclusion Criteria:

* Patients attended to IBD clinic at Tropical Department

Exclusion Criteria:

1. Age: less than 18 years
2. Unstable patients or need for ICU admission
Clinical Pharmacology of p38 MAP Kinase Inhibitor, VX-745, in Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or Mild AD

This study will assess the effects of VX-745 on markers of disease in the central nervous system of patients with MCI due to AD or with mild AD. The study will also evaluate the safety and tolerability of VX-745 in these patients during 6 weeks of dosing, as well as the plasma and cerebrospinal fluid concentrations of VX-745 during dosing.


Eligibility Criteria:
Inclusion Criteria:

* Age 60 - 85 (inclusive)
* Willing and able to provide informed consent
* Clinical presentation consistent with MCI due to AD or of mild AD

  * Gradual progressive decline in memory function over \>6 months
  * Amnestic presentation on neuropsychological testing with rapid forgetting (% reduction 1.5 standard deviations below the mean)
  * Clinical Dementia Rating (CDR) Sum of Box (SOB) score ≥0.5
  * Mini-Mental State Examination (MMSE) range: 20 to 30
* Brain hypometabolism by 18F-2-fluoro-2-deoxyglucose (FDG)-PET
* Participants may be taking medications for AD, provided that the dose of these medications has been stable for \>3 months.

Exclusion Criteria:

* Evidence of neurodegenerative disease other than AD
* Inability for any reason to undergo MRI scans (e.g. pacemaker, vascular stent or stent graft). Patients who require sedation for screening procedures such as MRI may receive a short-acting sedative.
* Psychiatric disorder that would compromise ability to comply with study requirements
* History of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with no significant progression over the past 2 years
* Significant cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder or metabolic/endocrine disorders or other disease that would preclude treatment with p38 MAP kinase inhibitor and/or assessment of drug safety and efficacy
* Recent (\<90 days) changes to AD medications prescribed for cognitive reasons or with the potential to impact cognition
* Psychotropic drugs taken within 1 month. Anticoagulant drugs taken within 1 week.
* Participation in a study of an investigational drug less than 6 months or 5 half-lives of the investigational drug, whichever is longer, before enrollment in the study
* Male subjects with female partner of child-bearing potential who are unwilling or unable to adhere to contraception requirements
* Female subjects who have not reached menopause or have not had a hysterectomy or bilateral oophorectomy/salpingoophorectomy
* Positive urine or serum pregnancy test or plans desires to become pregnant during the course of the trial
* Donation of \>500 mL of blood or blood products within 2 months
* History of alcohol and/or illicit drug abuse within 6 months.
* Infection with hepatitis A, B or C or HIV.
* Any factor deemed by the investigator to be likely to interfere with study conduction
COugh Among Hypertensive Patients Treated With Telmisartan, Who Had to Stop previoUs ACE-I Treatment Due to couGH in Poland

In the light of ONTARGET and TRANSCEND studies results, it would be interesting to investigate the real-life telmisartan treatment tolerability. It is well known and accepted that the Real-life setting is much more adequate to reflect the antihypertensive and safety properties of the drug in comparison to the organized and scheduled setting of the clinical trial. Because there are not much data on the cough in relation to telmisartan, therefore it would we worth to observe the cough frequency and general treatment tolerance in patients treated with telmisartan, who had to stop their previous ACE-I treatment due to cough.


Eligibility Criteria:
Inclusion Criteria: - hypertension

* age \> 18
* ACE-I related cough Exclusion Criteria: - Current treatment with telmisartan
* Cholestatic disorders and severe hepatic failure
* Allergy to telmisartan
* Pregnancy and lactation period