cyrilzakka/clinical-trials huggingface dataset:
Monitoring of Non-invasive Ventilation During Sleep in ALS

Non-invasive ventilation (NIV) has already shown to improve survival and quality of life in patients with amyotrophic lateral sclerosis (ALS). Quality of sleep seems already to be impaired in patients with preserved diaphragmatic dysfunction. Until now, only few research has been performed on the quality of sleep in patients with ALS when using NIV, and these data are mainly based on patient reported outcomes.Further on, only very little research has been done on patient-ventilator interaction.

Our study would like to perform research on quality of sleep before and after NIV use by using full polysomnography with incorporation of transcutaneous carbon dioxide measurement and built-in ventilator software.


Eligibility Criteria:
Inclusion Criteria:

* Patients with ALS (according to El Escorial criteria) who are planned to start to use NIV, objectivated by a decreased inspiratory muscle force with a restrictive pulmonary function and

  1. symptoms of nocturnal alveolar hypoventilation or
  2. increased daytime arterial carbon dioxide partial pressure (PCO2)(\> 45 mmHg) or
  3. a ≥ 10 mmHg increase in transcutaneous PCO2 during sleep in comparison to a normal awake supine value

Exclusion Criteria:

* Patients \< 18 years
* Patients not willing to start NIV
A Study in Healthy Volunteers to Compare Different Tablet Formulations of the Test Medicine, GLPG1972, Against the Current Tablet Formulation, and to Assess the Effect Food Has on One of the Test Medicines

The sponsor wants to investigate two new tablet formulations (recipes) of the test medicine, and how they are taken up by the body in comparison to the current tablet formulation (study periods 1 to 3). If one of the 2 new tablets has a more favourable profile than the current tablet in periods 1 to 3, the sponsor will then investigate the effect that food has on this new tablet in study period 4. However, if the new tablets do not have a more favourable profile than the current tablet, the food effect does not need to be investigated and study period 4 will not be needed.


Eligibility Criteria:
Inclusion Criteria:

* Male between 18-55 years of age (extremes included), on the date of signing the informed consent form
* A body mass index (BMI) between 18.0-30.0 kg/m2, inclusive
* Judged to be in good health by the investigator based upon the results of medical history, physical examination, vital signs, 12-lead ECG, and fasting clinical laboratory safety tests. Clinical laboratory safety test results must be within the reference ranges or considered not clinically significant in the opinion of the investigator
* Subject must be able and willing to comply with restrictions on prior medication as described in the protocol
* Negative screen for drugs (amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, opiates, methadone, tricyclic antidepressants) and alcohol

Exclusion Criteria:

* Known hypersensitivity to IMP ingredients or history of a significant allergic reaction to the investigational medicinal product (IMP) ingredients as determined by the investigator, and/or known sensitivity to IMP or the excipients (e.g. lactose). Hay fever is allowed unless active.
* Positive serology for hepatitis B virus surface antigen or hepatitis C virus or history of hepatitis from any cause with the exception of hepatitis A that was resolved at least 3 months prior to first IMP administration.
* History of or a current immunosuppressive condition (e.g. human immunodeficiency virus infection)
* Having any illness, judged by the investigator as clinically significant, in the 3 months prior to first IMP administration.
* Presence or sequelae of gastrointestinal, liver, kidney (creatinine clearance ≤80 mL/min, using the Cockcroft-Gault formula: if calculated result is ≤80 mL/min, a 24-hour urine collection can be done) or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
Comparison of Radiofrequency, Vein Stripping and CHIVA for Venous Insufficency

Randomized controlled clinical trial aimed to compare the effectiveness and safety of radiofrequency, saphenous vein stripping and conservative hemodynamic treatment of venous insufficiency (CHIVA) in the treatment of saphenous varicose veins, in terms of absence of saphenous vein reflux, patient quality of life and post-surgical complications.

A randomized controlled trial will compare three surgical techniques (stripping, CHIVA and radiofrequency) for the treatment of varicose veins which are currently considered interchangeable standards of care.

The trial will include symptomatic patients with chronic venous insufficiency and saphenous vein insufficiency confirmed by Doppler with diameter greater than 4 mm.

Clinical assessments will be made on first and seventh day after surgery, and then at months 1, 6, 12 and 24. The primary endpoint of the study is the absence of venous reflux in the great saphenous vein segment above-knee. Secondary variables will include VAS for pain and quality of life as assessed by the SF 36 and CIVIQ questionnaires validated in Spanish language. Ultrasound scans will be done the first week and after 1, 6, 12 and 24 months. Intra- and postoperative complications will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Insufficiency of internal major saphenous vein, confirmed by diameter greater than or equal to 4 mm, assessed by Eco- Dupplex.
* Age \> 18 years
* Informed consent

Exclusion Criteria:

* Recurrent varicose veins
* Post-thrombotic syndrome.
* Patients with active malignancies or severe ischemic heart disease.
* Serious liver disease
* Thrombophilia.
* Serious psychiatric diseases
To Observe the Impacts of Anti-Tumor Necrosis Factor (TNF) Effectiveness on Improvement in Work Place and Household Productivity for Patients With Psoriatic Arthritis (PsA)

This post marketing observational study is designed to provide the initial data on work impairment of PsA patients in Turkey, as well as changes in work impairment, life quality and clinical response during treatment with anti-TNF agents.


Eligibility Criteria:
Inclusion Criteria:

* Actively working, either full-time or part-time
* Previous confirmed diagnosis of PsA by a rheumatologist
* Patients for whom the physician has initiated PsA treatment with an Anti-TNF in accordance with Turkish Ministry of Health regulations and reimbursement criteria
* Able to provide authorization to use and disclose their health related information

Exclusion Criteria:

* Patients with a history of an allergic reaction or significant sensitivity to anti-TNF agents
* Patients with possible follow-up problems during the planned study period or patients who may not be compliant to treatment as evaluated by the investigator/treating physician
* Patients participating in any clinical trial of an experimental drug 30 days prior to the baseline visit
Study of Trimethoprim/Sulfamethoxazole as PCP Prophylaxis in CTD Patients

Evaluation the efficacy and safety profile of trimethoprim/sulfamethoxazole as Pneumocystis carinii pneumonia (PCP) prophylaxis in Patients With Connective Tissue Diseases (CTD) treated with high-dose glucocorticoids and immunosuppressive agents.

Open-labeled, randomized, prospective single-center clinical trial. Observation period of 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years with informed consent
* SLE, Sjögren syndrome, Polymyositis or Dermatomyositis, defined by consensus classification criteria
* concomitant high dose glucocorticoid, defined as \>1mg/kg/d prednisone or equivalent
* concomitant cyclophosphamide, cyclosporine or mycophenolate mofetil

Exclusion Criteria:

* Pregnant or lactating
* WBC\< 4×10\^9/L，PLT\<100×10\^9/L
* Serum ALT or AST \> 2 times upper limit of normal
* Serum creatinine \> 1.5 mg/dL
* Severe hepatic, hematological, gastrointestinal, pulmonary, cardiovascular, neurological, endocrine or cerebral disease
* Active infection, including HIV, HCV, HBV, tuberculosis or PCP
* concomitant antibiotics other than trimethoprim/sulfamethoxazole
* Patient with malignancy
* Drug allergy, especially trimethoprim/sulfamethoxazole
Assessing the Use of Nicotine Gum to Decrease Betel Nut Chewing in Saipan

The study will include a prospective, randomized, double-blinded trial, with a total of 45 subjects enrolled. Research subjects will be recruited from a population of adult patients (current patients at Commonwealth Healthcare Corporation) 18 years or older who are daily betel nut chewers who add tobacco to their chew. One of the study team members will be traveling to Commonwealth of Northern Mariana Islands and a letter of support has been obtained in order to conduct the study.

Eligible patients must be non-tobacco smokers, be actively interested in betel nut reduction or cessation, and chew at least four times a day on average. Subjects will be randomized equally into three distinct groups for the purpose of this study:

* non-medicated regular chewing gum
* nicotine 2 mg gum
* nicotine 4 mg gum

Objectives include:

A. Assess the efficacy of nicotine gum as a replacement therapy in reducing betel nut usage among adult betel nut chewers in Saipan.

B. Determine if larger doses of nicotine in gum are associated with statistically significantly greater reductions in betel nut usage.

C. Leverage results from this study as a means to explore further if nicotine gum would be helpful in decreasing betel nut consumption.

Eligibility Criteria:
Inclusion Criteria:

* Daily betel nut chewers who use betel nut and tobacco in their chews.
* Interested in betel nut reduction or cessation when they are informed of the study.
* Must chew greater than or equal to 4 times a day.
* Must have an appointment with a provider at the Commonwealth Healthcare Corporation

Exclusion Criteria:

* Tobacco smokers
* Under the age of 18 years old
* Potential subjects unable to accurately estimate the number of average betel nut chews per day (will be able to re-present for enrollment if they are able to make an accurate estimate of chews per day after keeping a personal record chew for one week or more)
* Pregnant patients
* Established diagnosis of oropharyngeal cancer
Vestibular Function Using Mitochondrial Antioxidant Therapy

To determine if supplementation with known mitochondrial antioxidants (alpha lipoic acid (ALA) and CoQ-10) will stabilize or improve vestibular function in older adults.

The subjects will be divided into two groups, half will be given daily supplementation with ALA and CoQ-10. The second group will only receive standard of care treatment, with no study drug intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Community dwelling non-gender specific aged 65-90 years of age
2. For female subjects, confirm that they are post-menopausal
3. Diagnosed with vestibular dysfunction
4. Able to provide informed consent
5. Prepared to adhere to study drug regimen and attend all study visits

Exclusion Criteria:

1. Unable to provide informed consent
2. Allergy/sensitivity to the study drugs or any of their ingredients
3. Unable to adhere to study drug regimen or to attend study visits.
4. Current or past participation within a specified timeframe in another clinical trial, as warranted by the administration of this intervention.
5. Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
6. Anticoagulant drugs: Anisindione (Miradon), dicumarol and warfarin (Coumadin and Jantoven)
7. Participants who are currently undergoing treatment with Insulin, Levothyroxine or chemotherapy drugs.
8. Participants who are undergoing treatment with theophylline.
Messaging Therapy for Depression and Anxiety: A Longitudinal Effectiveness Study

Therapies delivered via technology have been developed to improve accessibility, however, there is limited research regarding messaging therapy in particular, and none that we know of utilizing a longitudinal effectiveness design. The aim of this study was to investigate the overall effectiveness of messaging therapy, identify any contributors to its effectiveness, and to evaluate a dosage effect for this type of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed Depression and/or Anxiety Disorder

Exclusion Criteria:

* Any psychosis related symptoms or disorders
Effectiveness of Thyme in the Management of Clinical Symptoms in Patients with Irritable Bowel Syndrome

The goal of this clinical trial is to learn if thyme supplement enhances the effects of a low FODAMP diet on reducing clinical symptoms and improving the quality of life of patients with irritable bowel syndrome or not.

The main questions it aims to answer are:

1. Does consumption of thyme reduce the severity score of clinical symptoms in patients with irritable bowel syndrome?
2. Does consumption of thyme increase the quality of life score in patients with irritable bowel syndrome? Researchers will compare thyme supplementation with placebo to see if thyme supplement enhances the effects of a low FODAMP diet on clinical symptoms and quality of life in patients with irritable bowel syndrome.

Participants will:

1. Receive thyme supplement plus a low FODMAP diet or placebo with low FODMAP diet for 8 weeks.
2. Recorde 3 days (1weekend and 2 workday) dietary recalls at week 4 and week 8 to assess adherence to the low FODMP diet.
3. Visit the clinic at the beginning of the study and the end of the study for a check-up and score record


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-65;
* Patients with irritable bowel syndrome;
* Body Mass Index in the range of 18-25 kg/m2

Exclusion Criteria:

* Any organic intestinal disease;
* Medical history of chronic gastrointestinal and colorectal disease;
* Any major bowel surgery;
* Medical history of liver and kidney disorders;
* Regular use of laxative, anti-diarrhea and anti inflammatory medications.
Exploring the Volume-Outcome Relationship for PCI Procedures Undertaken in a UK Context: A NICOR Study

The relationship between annual procedural volume and patient outcome remains a debated issue in the field of interventional medicine. An under-explored issue in a UK context is whether or not such a relationship exists for percutaneous coronary interventions (PCI). In recent years, this procedure has replaced thrombolysis as the standard intervention method used in UK hospitals for widening patients' obstructed coronary arteries. However, the actual number of such procedures currently undertaken annually remains variable across hospitals where these interventions are performed. The UK's National Institute for Health and Care Excellence has consequently called for research into whether such differences in volume play any role in patient outcome for this particular procedure. The current study is intended to address that research need, and will do so by looking at whether the annual number of PCI procedures undertaken by individual hospitals is predictive of patient mortality post-procedure.

Using data collected as part of a UK national audit of percutaneous coronary interventions, this study will:

* Establish whether annual hospital volume is a clinically important novel risk factor for 30-day mortality post-PCI when examined relative to a newly developed risk model intended for use in clinical practice.
* Establish whether the nature of this volume-outcome relationship is best fit as a linear or non-linear model.
* Establish whether annual hospital volume is a clinically important novel risk factor for 30-day mortality post-primary PCI when examined relative to a newly developed risk model intended for use in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* are aged between 18 and 100 (inclusive) on the date of their procedure;
* do not have pre-operative ventilation;
* undergo a PCI procedure in a UK hospital that contributes data to the National Audit of Percutaneous Coronary Intervention; and
* have a tracked mortality status at 30 days' post-procedure.

To account for potential dependencies in the data, patients' non-index (i.e. follow-up) PCI procedures occurring during the data collection period will be excluded from the study sample.
mGlide-Care: A Partnership With Caregivers

Hypertension (HTN) is the most significant stroke, cardiovascular disease and dementia risk factor and is substantially under-treated especially in older persons. In this study the investigators will develop mGlide-Care to address uncontrolled HTN in people with mild cognitive impairment (MCI) and early stage Alzheimer's Disease and Alzheimer's Disease Related Dementia (AD/ADRD). mGlide-Care is adapted from mGlide which is a mHealth (mobile health technology) mediated care model for HTN care. Aim 1 will engage stakeholders to study the acceptability of mHealth mediated HTN care and will use their input to develop mGlide-Care. Stakeholders are persons with early stage AD/ADRD and MCI, unpaid family caregivers, primary care providers, geriatricians and clinical pharmacists. Aim 2 is a feasibility pilot to test mGlide-Care vs. usual care in 75 participants with uncontrolled HTN and early stage AD/ADRD or MCI. Caregivers will assist participants. Outcomes will include HTN control and participant and caregiver reported measures.


Eligibility Criteria:
Inclusion Criteria: Must meet all criteria

* Diagnosed with early stage AD/ADRD or MCI
* Have uncontrolled hypertension (HTN)
* Have an unpaid, family caregiver
* Have established medical diagnosis of hypertension (HTN)
* English speaking
* Participant or caregiver must have a smartphone or mobile device (e.g. iPad) that can transmit blood pressure (BP) from the BP monitor
* Participant and caregiver capable and willing to comply with the entire study protocol
* Able to give voluntary written informed consent.

Exclusion Criteria: Any of the following will be an exclusion.

* Severe comorbid illness including end-stage kidney disease, end-stage liver disease, and life expectancy \<1 year, or if medical complexity of the patient precludes clinical trial participation
* Active illicit drug use (e.g. cocaine, methamphetamines, opioids, phencyclidine) since this will interfere with HTN management
* Participant and caregiver unable to complete study tasks, including are homeless, will leave the country, or will relocate in the next 12 months
* Serious psychiatric illness that could interfere with treatment, assessment, or compliance including significant delusional disorders such as schizophrenia and bipolar illness
* Unable or unwilling to give consent.
Group Cognitive Processing Therapy for Combat-related Posttraumatic Stress Disorder (PTSD)

The purpose of this study is to compare group-administered Cognitive Processing Therapy-Cognitive-only version (CPT-C), an evidence based treatment for posttraumatic stress disorder (PTSD), to Present Centered Therapy (PCT) in order to determine whether the results of CPT exceed those of receiving a therapy that focuses on current problems rather than past trauma in a group format.

Estimates indicate that between 100,000 and 300,000 Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF) veterans are at significant risk for chronic post-traumatic stress disorder (PTSD), which can become a chronic disorder that impacts all areas of a person's life. PTSD treatment programs are being developed throughout the Department of Defense (DoD) and the Veterans Affairs (VA), but because of the large number of Service Members returning from deployment with PTSD, it is often necessary to provide psychotherapy in groups. Cognitive Processing Therapy (CPT), an evidence-based treatment for PTSD, was originally developed as a group-based intervention. However, group-based CPT treatment has never been systematically compared to other forms of group treatment. The public policy implications of the results of this trial are significant. If group treatment is found to be effective, then group treatment would be a more efficient and cost-effective therapy modality in most cases. The purpose of this study is to compare group-administered CPT-Cognitive-only version (CPT-C) to Present Centered Therapy (PCT) in order to determine whether the results of CPT exceed those of receiving a therapy that focuses on current problems rather than past trauma in a group format. One hundred (100) adult male and female active-duty OIF/OEF military personnel over 18 years of age will be enrolled into this study. Participants will be randomized to receive either group PCT or group CPT-C.

Eligibility Criteria:
Inclusion Criteria:

* Adult male and female active duty, activated Reservist, or activated National Guard OIF/OEF military personnel or OIF/OEF veterans seeking treatment for PTSD
* diagnosis of PTSD determined by a clinician-administered Posttraumatic Stress Scale (PSSI)
* person has experienced a Criterion A event that is a specific combat-related event or high magnitude operational experience that occurred during a military deployment in support of OIF/OEF. The diagnosis of PTSD may be indexed to that event or to another Criterion A event.
* be over the age of 18
* speak and read English
* be stable on any psychotropic medications they may be taking.

Exclusion Criteria:

* current suicide or homicide risk meriting crisis intervention
* active psychosis
* moderate to severe brain damage (as determined by the inability to comprehend the baseline screening questionnaires)
Surfactant for Neonatal Respiratory Distress Syndrome(NRDS) and Neonatal Acute Respiratory Distress Syndrome(NARDS)

In preterm infants with neonatal respiratory distress syndrome (NRDS), exogenous pulmonary surfactant(PS) replacement therapy is one of the most important therapeutic breakthrough to reduce neonatal mortality. Nowadays, PS is commonly used in newborn infants with respiratory distress, but the incidences of bronchopulmonary dysplasia(BPD) and/or death are inconsistent. The result indicates that not all preterm infants with respiratory distress can be beneficial from PS.

In 2017, the international neonatal ARDS (NARDS) collaborative group provides the first consensus definition for NARDS. And whether or not PS being beneficial for preterm infants with NARDS remains unknown.

To date, PS is not recommended to adult and pediatric ARDS. Meantime, systematic review indicates that PS does not demonstrate statistically significant beneficial effects on reducing the mortality and the rate of BPD in term and late preterm infants with meconium aspiration syndrome(MAS). Therefore, a reasonable speculation is that preterm infants with NARDS do not benefit from one dose of PS. And the speculation can explain why not all preterm infants with respiratory distress can be beneficial from PS. In the era of pre-NARDS, the preterm infants fulfilling the definition of NARDS may have been considered as NRDS in the first three days after birth.

According to the diagnostic criteria of NARDS, a key procedure for diagnosis of NARDS is to exclude the newborn infants with NRDS. But no detailed procedures are available to differentiate NRDS from NARDS.

Eligibility Criteria:
Inclusion Criteria:

Eligibility requirements for neonates were as follows:

* The gestational age is less than 37 weeks and admitted to neonatal intensive care unit(NICU) in 24 h after birth
* The neonates will be diagnosed with NRDS or NARDS
* The neonates will be at least administrated one dose of surfactant

Exclusion Criteria:

one of the following criteria will be needed

* major congenital anomalies
* chromosomal abnormalities
* upper respiratory tract abnormalities