cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy Study to Determine Anti-Asthmatic Effect of Esomeprazole Magnesium; Nexium Reflux Asthma

The purpose of this study is to determine whether treatment with esomeprazole for 6 months will improve asthma in adult patients with moderate to severe asthma and symptoms of gastroesophageal reflux disease.


Eligibility Criteria:
Inclusion Criteria:

* Adults with diagnosis of asthma since at least 6 months.
* Symptoms of asthma during run-in.
* At least 3 months history and present symptoms of 1 or more of the following: burning feeling behind breastbone, pain behind breastbone, acid taste in the mouth.

Exclusion Criteria:

* Patients with clinically relevant abnormalities.
* Patients with a smoking history of ≥10 pack-year.
* Patients who have had previous surgery on the esophagus or the stomach.
Phase III General Clinical Study of NPO-11 in Patients Undergoing Gastric Endoscopy

Patients who require gastric endoscopy, including the patient population\* excluded from the phase III controlled clinical study of NPO-11, will receive an intragastric single dose of NPO-11 20 mL. The efficacy of NPO-11 as a premedication for endoscopy will be evaluated based on the percentage of patients having no gastric peristalsis at both 2 minutes post-dose and the end of endoscopy (primary outcome measure).

The safety of NPO-11 will be evaluated based on adverse events and adverse drug reactions (ADRs) observed between administration and seven days after administration.

Patient population excluded from the phase III controlled clinical study of NPO-11

* Patients with reflux esophagitis
* Patients with active gastric or duodenal ulcers
* Patients who undergo endoscopy under sedation
* Patients who undergo endoscopy with a scope of \<9 mm in diameter


Eligibility Criteria:
Inclusion Criteria:

Inpatients or outpatients of either sex who meet criteria (1) and (2) below will be enrolled in the study. Patients have to provide written informed consent for voluntary participation in the study.

1. Patients who require gastric endoscopy (except for emergency endoscopy or endoscopy for comprehensive medical examination)
2. Patients who are older than 20 years at the time of consent

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from the study. The criteria (2) and (3) will be confirmed during endoscopy. Patients who meet any of these criteria will be withdrawn from the study at the time of confirmation.

1. Patients with a history of surgery to the stomach
2. Patients with severe gastric stenosis or deformation which makes observation of gastric peristalsis difficult
3. Patients with upper gastrointestinal bleeding which requires hemostasis
4. Patients on cancer treatment (chemotherapy or radiotherapy)
5. Patients with a history of shock or hypersensitivity to l-menthol or peppermint oil (mint oil)
6. Patients with a history of shock or hypersensitivity to lidocaine hydrochloride
7. Pregnant or lactating women, women of childbearing potential, or women who plan to become pregnant during the study
8. Patients who have been exposed to NPO-11
9. Patients who have received other investigational drugs within four months before consent or who are participating in other clinical studies
10. Patients otherwise ineligible for participation in the study in the investigator's or subinvestigator's opinion
Safety and Efficacy Study of Transplantation of EPCs to Treat Idiopathic Pulmonary Arterial Hypertension

Experimental data suggest that transplantation of endothelial progenitor cells (EPCs) attenuates monocrotaline-induced pulmonary hypertension in rats and dogs. In addition, clinical studies suggest that autogolous progenitor cells transplantation is feasible and safe in patients with ischemic disease. This study will investigate the feasibility, safety, and initial clinical outcome of intravenous infusion of autologous EPCs in patients with idiopathic pulmonary arterial hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of idiopathic pulmonary arterial hypertension
* in New York Heart Association (NYHA) functional class II to III
* a mean pulmonary artery pressure more than 30 mmHg on right heart catheterization
* the ability to walk ≥50 m during a standardized 6-minute walk test.

Exclusion Criteria:

* Pulmonary hypertension as a result of heart disease, pulmonary disease, sleep-associated disorders, chronic thromboembolic disease, autoimmune or collagen vascular disease, HIV infection, liver disease, NYHA functional class IV, major bleeding requiring blood transfusion, diabetes, renal dysfunction, and evidence for malignant diseases were excluded
Dacomitinib (PF-00299804) in Advanced/Metastatic Squamous Cell Carcinoma of the Penis

Penile squamous cell carcinoma (SCC) is a very rare disease and prognosis depends primarily on regional lymph-node involvement. Despite the fact that cure can be obtained in patients with low metastatic load (pN1) by monotherapy, combination therapy is required for more advanced cases. Medical treatment options only for advanced or metastatic penile SCC are not very effective so far and the few chances for cure are solely dependent on multimodality treatment, either with surgery or radiation. Based on the observation that the epidermal growth factor receptor (EGFR) is almost invariably expressed in penile SCC and assuming similarities to the SCC of head and neck district, anti-EGFR targeted monotherapy has been investigated with promising early results at Istituto Tumori Milan and University of Texas MD Andreson Cancer Center. These premises lend support to the use of the pan-HER inhibitor dacomitinib for advanced or metastatic penile SCC.


Eligibility Criteria:
Inclusion Criteria:

* Patients must provide written informed consent
* Eastern Cooperative Oncology Group performance status of at least 1
* Cytologically or histologically proven diagnosis of SCC of the penis
* Uni- or bidimensionally measurable disease as defined by RECIST v1.1 criteria
* Clinical stage N2-3 and/or M1 (TNM 2002)
* Locoregional relapse after prior major surgery/ies (either single or multiple)
* No prior systemic therapy except for the administration of vincristine-bleomycin-methotrexate (VBM) chemotherapy for superficial disease if administered at least 6 months prior to study enrollment
* Adequate bone marrow, liver and renal function

Exclusion Criteria:

* Central nervous system (CNS) metastases or leptomeningeal carcinomatosis
* History of active serious cardiovascular, cerebrovascular, pulmonary co-morbidities
* Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma or any cancer curatively treated \> 5 years prior to study entry.
Anti-hypertensive Medication Dosing Regimen in Effective Blood Pressure Control

A randomised crossover trial of anti-hypertensive medication dosing regimen in effective blood pressure control.

To investigate whether there is a difference in 24 hour blood pressure (BP) control when antihypertensive medications are taken in the morning compared with the evening.

The identification of any significant difference could lead to more effective therapeutic management of arterial hypertension, which in turn would result in a reduced cardiovascular burden, lower costs and a better quality of life for hypertensive patients.

Eligibility Criteria:
Inclusion Criteria:

* Caucasian patients aged 18-80 years;
* History of any grade of hypertension for at least 1 year, including at least 3 months of constant antihypertensive medication (consisting of ≥ 1 antihypertensive drugs, each administered in one dose daily), with reasonably controlled BP (≤150/90 mmHg and ≥ 115/75 mmHg on usual medication) based on previous clinic records, in the last 3 months.

Exclusion Criteria:

* BP levels \> 150/90 mmHg or \< 115/75 mmHg in the last 3 months.
* Postural hypotension, defined as symptoms resulting from a \> 20 mm Hg drop of systolic BP or a \> 10 mm Hg drop of diastolic BP or both between 1 and 3 min after standing from the sitting position.
* Known Extreme dippers at baseline (fall of mean night time SBP \> 20% of mean day time SBP)
* Individuals with jobs which require night-time shift work.
* Pregnant women or those planning to become pregnant.
Impact of Medication Therapy Management Intervention on Treatment Outcomes and Medication Adherence Among Adult Patients Comorbid With Diabetes Mellitus and Hypertension at Outpatient Clinics

The goal of this interventional study was to assess the impact of medication therapy management on treatment outcomes and medication adherence among adult patients comorbid with diabetes mellitus and hypertension at outpatient clinics in Southwest Ethiopia. The patients attending hospitals assigned to interventional group received medication therapy management services in addition to usual care.

This study aimed to assess the impact of medication therapy management intervention on treatment outcomes and medication adherence among patients comorbid with diabetes mellitus and hypertension at outpatient clinics in Southwest Ethiopia. A cluster randomized controlled trial was conducted at outpatient clinics of public hospitals in Southwest Ethiopia from March to December, 2022. Hospitals were randomly assigned to either the interventional or the control group. The patients attending hospitals assigned to interventional group received medication therapy management services in addition to usual care and those attended hospital assigned to control group received the usual care only. A systematic random sampling technique was used to select the study participants from each hospital. The differences in proportion between the groups was determined using the Pearson chi-square. The independent sample t-test was be done to compare means between groups and paired t-test was used to compare means in between intervention and controlled group. The p-value of \< 0.05 was used as a cut-off point to declare statistical significance.

Eligibility Criteria:
Inclusion Criteria:

* age is greater than or equal to 18 years
* diagnosed with both diabetes mellitus and hypertension

Exclusion Criteria:

* unwillingness to participate
* mentally disabled
* lost to follow-up
* change follow up site
* pregnant women
Steroid Withdrawal in Pediatric Renal Transplant Recipients Under Cyclosporine (CyA) and Mycophenolate Mofetil (MMF)

The present study investigates the safety and efficacy of steroid withdrawal in pediatric renal transplant recipients with stable graft function under concomitant immunosuppression with cyclosporine and mycophenolate mofetil.

The present protocol aims to investigate the steroid-saving potential of MMF in pediatric patients after NTx. Over a 2-year period, two treatment regimes will be compared in randomized form in patients with a stable renal transplant function in the course of 12 - 24 months after transplantation (controlled first study phase):

Branch A: CyA + MMF + withdrawal of steroids over a three-month period following randomization

Branch B: CyA + MMF + 4 mg/m² methylprednisolone (or prednisolone equivalent)/day

After two years of observation, steroids in the control group (branch B) can be withdrawn optionally in conformity with the same protocol as in branch A (uncontrolled second study phase). It is to be expected that part of the patients will decide in favour of a withdrawal of steroids. In the uncontrolled second study phase, a comparison will thus be drawn among three therapy groups over a period of another 15 months (altogether 3.5 years beginning with randomization), in order to throw some light on the medium-term effect of steroid-free immunosuppression on length growth and transplant function.

Eligibility Criteria:
Inclusion Criteria:

* Age \< 18.0 years
* Bone age of boys \< 15 years, of girls \< 13 years
* Patients 12-24 months after renal transplantation with stable transplant function
* First or second kidney transplant, living or cadaver kidney donation
* Triple immunosuppression with cyclosporine (CyA), MMF, and daily steroids at study entry
* Patients and parents, respectively, have given their written consent after enlightenment (informed consent)

Exclusion Criteria:

* Irreversible rejection of former transplant within 6 months
* Highly reactive (\> 80%) lymphocytotoxic antibodies within 12 months prior to transplantation
* Anamnestically steroid-resistant rejection of current transplant
* More than 2 acute rejection reactions prior to study entry (i.e., in the first 12-24 months after kidney transplantation) or 1 acute rejection reaction during the last 6 months before study entry
* Glomerular filtration rate (GFR) \< 40 ml/min/1.73 m² (Schwartz formula) at study entry
* Acute rejection reaction or unstable transplant function (increase of serum creatinine \> 20%) during the last 6 months before study entry or histologically confirmed chronic rejection reaction
* Suspected insufficient medication compliance
* Patients receiving a basic immunosuppression other than that prescribed in this protocol
* Simultaneous therapy with growth hormone after renal transplantation
Non-invasive Hemoglobin Monitoring in Congenital Heart Diseased Children

The investigators will evaluate the accuracy of non-invasive hemoglobin monitor (Sp-Hb) compared to traditional laboratory hemoglobin (Lab-Hb) in children with congenital heart disease. The investigators will also compare the accuracy of Sp-Hb in cyanotic children to acyanotic children.

Blood hemoglobin is measured daily in clinical practice. Laboratory measurement (Lab-Hb) of is the gold standard for assessment of blood hemoglobin. Recently, non-invasive monitors had been introduced. Non-invasive measurement of hemoglobin (Sp-Hb) would save time and minimize the risk of infection. Blood sampling in children is usually more difficult and stressful; moreover, it also carries the risk of iatrogenic anemia.

Radical-7 (Masimo corporation, Irvine, CA) is a device that operates using the principle of co-oximetry . Radical-7 had been validated in various clinical purposes. Measurement of blood hemoglobin is an important application for Radical-7 device. Non-invasive hemoglobin (Sp-Hb) measurement has been frequently validated in adults; as well as in pediatric patients; however, its accuracy in children with congenital heart disease was not investigated. Congenital heart disease infants usually undergo major operations and frequently need transfusion of blood. Moreover, these patients have special circulatory physiology that might impact the device accuracy. It had been recently reported that the performance of co-oximetry in congenital heart disease children is poor in measurement of oxygen saturation specially at oxygen saturation under 75%; however, its accuracy in measurement of hemoglobin was not investigated yet. In this study, the investigators will evaluate the accuracy of Sp-Hb compared to traditional Lab-Hb in children with congenital heart disease. the investigators will also compare the accuracy of Sp-Hb in cyanotic children to acyanotic children.

Eligibility Criteria:
Inclusion Criteria:

* infants and children less than 8 years
* with congenital heart disease

Exclusion Criteria:

* refusal of the patient surrogate to share in the study
Pain Management Using Mobile Technology in Veterans With PTSD and TBI

Up to half of military veterans with traumatic brain injury (TBI) also suffer from co-occurring posttraumatic stress disorder (PTSD). Both are linked to higher risk of chronic pain, one of the most common health complaints among U.S. veterans who served in Operation Enduring Freedom (Afghanistan), Operation Iraqi Freedom (Iraq), and Operation New Dawn (OEF/OIF/OND). However, pain medications elevate risk of opioid abuse, and studies indicate that veterans perceive barriers to traditional mental health treatments. Little research exists regarding non-pharmacological, technology-based interventions designed to reduce pain in veterans with PTSD and TBI. Mobile technology used to implement neurofeedback (EEG biofeedback) shows promise in providing a portable, low-cost intervention for reducing pain in veterans with co-occurring disorders. We aim to test the feasibility and effectiveness of using mobile neurofeedback devices for reducing pain symptoms in veterans with PTSD and TBI. Veterans with PTSD, TBI, and chronic pain will receive a NeuroSky headset (which reads EEG brain waves) and an iPod Touch with an app called Mobile Neurofeedback (which provides neurofeedback to induce relaxation). Veterans are taught how to use these together to do neurofeedback themselves at home for 12 weeks. Guided by existing research and preliminary data, we hypothesize that participants will show high levels of adherence to the NeuroSky + Mobile Neurofeedback intervention for the 3-month study duration and that participants will show statistically significant reduction in pain symptoms at 3 months compared to baseline. Given links between pain and other outcomes in veterans, we will also explore effects on drug abuse, violence, and suicidality. When the research is complete, the field will be changed because we will know whether new technology reading EEG brainwaves can be used to treat symptoms among individuals suffering from chronic pain. We will also know whether neurofeedback shows promise as an effective intervention for veterans with PTSD and TBI to reduce pain and related outcomes. If this program of research is successful, its impact will be to shift approaches to managing pain in clinical practice, for both veterans and civilians


Eligibility Criteria:
Inclusion Criteria:

* Military veteran who served during Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), and/or Operation New Dawn (OND)
* Posttraumatic Stress Disorder (PTSD)
* Traumatic Brain Injury (TBI)
* Chronic pain

Exclusion Criteria:

* History of epilepsy, seizure disorder, or have ever had a seizure or epileptic fit
* Pregnancy or breastfeeding
Influence of PESF on Oxygen Saturation, Quality of Life and Exercise Capacity in COPD

The effect of PESF (Pulsating Electrostatic Field) on the oxygen saturation, quality of life and the exercise capacity will be studied in a randomized, dubbel blind, placebo-controlled parallel design with 32 COPD patients GOLD III and IV with a oxygen saturation below or equal to 90%.

The patients will be treated with three 30-minute PESF- or placebo-sessions distributed over 5 days.

Directly before the first session, oxygen saturation, quality of life (CCQuestionnaire), exercise capacity (6-MWT and grip strength) and phase angle (BIA) will be measured and compared to the results directly after the third session. Oxygen saturation is also monitored during 24 hours after each session.


Eligibility Criteria:
Inclusion Criteria:

* COPD patients, post-bronchodilator FEV1/FVC \<70% and FEV1 \<50% predicted
* oxygen saturation without suppletion \<=90% (home use of oxygen suppletion is allowed, but will be stopped during PESF-treatment)
* Stable medication (no foreseeable need to change therapy)
* Able to understand the purpose and method of research after adequate information and the ability to decide on participation
* Signed informed consent

Exclusion Criteria:

* Known malignant condition with limited life expectancy
* Carrier of electrical equipment (pacemaker, ICD etc)
* COPD exacerbation in the last 3 weeks
* Woman who are pregnant or of childbearing age without effective contraception
* Manifest acute infection
* Patients with manifest decompensatio cordis
* Rehabilitation/reactivation program within 2 months before or during the study
Evaluation of the Cosmetic Performance of AIR OPTIX® COLORS

The purpose of this study was to evaluate the cosmetic performance of AIR OPTIX® COLORS contact lenses compared to FRESHLOOK® COLORBLENDS contact lenses in habitual FRESHLOOK® COLORBLENDS contact lens wearers.

In this non-dispensing trial, each participant wore 4 pairs of color contact lenses (gray, blue, green, hazel) sequentially for less than 10 minutes each in a contralateral fashion (test lens in one eye, control lens in the other eye). Randomization took place for each of the 4 pairs of lenses as to which eye (left or right) wore the test and which wore the control. Participants were selected based on eye color (dark vs light/medium). The primary analysis population (AP1) was pre-specified as participants of any eye color who habitually wore FRESHLOOK® COLORBLENDS lenses in one of the four colors tested in this trial. Pair 1 lenses were dispensed per the participant's habitual lens color.

Eligibility Criteria:
Inclusion Criteria:

* Sign written Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document.
* Have spectacles that provide acceptable near vision to wear over study lenses as needed to evaluate cosmetics of the lenses.
* Habitually wear FRESHLOOK® COLORBLENDS lenses at least two days per week.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Eye injury or surgery within twelve weeks of enrollment in this trial.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Currently enrolled in any clinical trial.
* Evidence of systematic or ocular abnormality, infection, or disease which is likely to affect successful wear of contact lenses or use of accessory solutions as determined by the investigator.
* Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
* Other protocol-defined exclusion criteria may apply.
Postoperative Recovery After Thoracic Surgery

A questionaire specifically developed using in depth interviews with patients that has undergone surgery has been developed. This questionaire will be used for longterm follow in patients undergoing thoracic surgery. 200 patients will be asked to fill in this questionaire preoperatively as well as 3 and 12 months after surgery to assess symptomburden after surgery with specific aim to study postoperative pain as well as other physical, mental and cognitive problems that may affect the patient and their daily activities, health, return to work, family life and economy.

In Sweden around 400 000 patients under go surgical operations in hospitals. A large proportion, around 20%, develop persistent postoperative pain which affects their quality of life and their recovery towards a normal life.

A questionaire specifically developed using in depth interviews with patients that has undergone surgery has been developed. This questionaire will be used for longterm follow in patients undergoing thoracic surgery. 200 patients will be asked to fill in this questionaire preoperatively as well as 3 and 12 months after surgery to assess symptomburden after surgery with specific aim to study postoperative pain as well as other physical, mental and cognitive problems that may affect the patient and their daily activities, health, return to work, family life and economy.

Eligibility Criteria:
Inclusion Criteria:

Patients undergoing thoracic surgery (thoracotomy or thoracoscopy) who accept to participate in the study

Exclusion Criteria:

None