cyrilzakka/clinical-trials huggingface dataset:
A Study to Investigate the Safety and Efficacy of ABBV-105 Alone or in Combination With Upadacitinib (ABBV-599 Combination) in Participants With Active Rheumatoid Arthritis

This was a phase 2 study to evaluate the safety and efficacy of elsubrutinib (ELS) and ABBV-599 (ELS plus upadacitinib \[UPA\]) vs placebo on a background of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) for the treatment of signs and symptoms of rheumatoid arthritis (RA) at 12 weeks in biological disease-modifying anti-rheumatic drugs (bDMARD)-inadequate response (bDMARD-IR) or bDMARD-intolerant participants with moderately to severely active RA and to define optimal dose for further development.

This was a 12-week, randomized, double-blind, parallel-group, Phase 2, dose exploratory, multicenter study. Participants who met eligibility criteria were randomized in a 3:2:2:2:2:1 ratio to 1 of 6 treatment groups: ABBV-599 \[UPA 15 mg/ELS 60 mg\]); ELS 60 mg/UPA placebo; ELS 20 mg/UPA placebo; ELS 5 mg/UPA placebo; UPA 15 mg/ELS placebo; and ELS placebo/UPA placebo. The study included a 35-day maximum screening period and a 12-week treatment period with 30-day follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of rheumatoid arthritis (RA) for ≥ 3 months based on the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for RA
* Participant meets the following minimum disease activity criteria:

  * ≥ 6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits
  * High-sensitivity C-reactive protein (hsCRP) ≥ 3 mg/L (central lab) at Screening Visit
* Participants must have been treated for ≥ 3 months with ≥ 1 biologic disease-modifying anti-rheumatic drug (bDMARD) therapy but continue to exhibit active RA or had to discontinue due to intolerability or toxicity, irrespective of treatment duration
* Participants must have been receiving conventional synthetic disease-modifying anti-rheumatic drug (csDMARD) therapy ≥ 3 months and on a stable dose for ≥ 4 weeks prior to the first dose of study drug
* Participants must have discontinued all bDMARDs prior to the first dose of study drug

Exclusion Criteria:

- Participant has prior exposure to any Janus Kinase (JAK) inhibitor for greater than 2 weeks (including but not limited to upadacitinib, tofacitinib, baricitinib, and filgotinib). A washout period of ≥ 30 days is required for any JAK inhibitor prior to the first dose of study drug.
CARE - Quality Improvement in Asthma Secondary Prevention in Primary Care, Through Delegation of Consultations to the Nurse.

Quality Improvement in Primary Care: delegation of check-ups to nurses in general practice


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with asthma

Exclusion Criteria:

* patients with copd
A Study Evaluating Efficacy of ABT-888 in Combination With Temozolomide in Metastatic Melanoma

The purpose of this study is to evaluate the efficacy of ABT-888 in combination with temozolomide versus temozolomide alone in subjects with metastatic melanoma.


Eligibility Criteria:
Inclusion Criteria:

* Histologically (or cytologically) confirmed metastatic melanoma.
* Unresectable Stage III or Stage IV metastatic melanoma.
* Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
* Subjects with no history of brain metastases demonstrated by a baseline MRI, or subjects with a history of previously treated brain metastases who have history of operable/SRS treatable brain metastases and completed surgical resection/stereotactic radiosurgery with or without adjuvant whole brain radiation at least 28 days prior to Day 1; have baseline MRI that shows no evidence of active intercranial disease; have discontinued taking medications for symptom management of brain metastases at least 7 days prior to Day 1
* 28 days since prior anti-cancer therapy.
* Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1.
* Adequate hematologic, renal and hepatic function.
* Partial Thromboplastin Time (PTT) is \<= 1.5 x upper normal limit of institution's normal range and international normalized ratio (INR) \< 1.5.
* Subject's with significant fluid retention may be allowed at the discretion of the investigator.
* Life expectancy \> 12 weeks.
* Females must not be pregnant.
* Voluntarily signed informed consent.

Exclusion Criteria:

* Lactate Dehydrogenase (LDH) \> 2 x Upper Limit of Normal (ULN).
* Ocular malignant melanoma.
* History of central nervous system metastases or leptomeningeal disease.
* Prior treatment with Dacarbazine (DTIC) or Temozolomide (TMZ).
* Prior DNA damaging agents or cytotoxic chemotherapy.
* Prior Whole Brain Radiation Therapy (with exceptions).
* Received an investigational agent within 28 days of study.
* History of seizure disorder and/or taking medication for seizure disorder.
* Active malignancy within the past 5 years, except cervical cancer in situ, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin.
* Medical condition that would cause a high risk for toxicities.
RFC and MTHFR SNPs & hENT1- dCK Expression as Prognostic Factors in ALL & hENT1- dCK Expression as Prognostic Factors in AML

Results of actual treatment in ALL are not optimal. New prognostic factors, which may determine clinical \& molecular response are required. Hyper-CVAD is an internationally accepted schema for such patients. The objective of this pilot study is to evaluate polymorphisms regarding RFC (reduced folate carrier) and MTHFR enzyme, which may affect the function of these proteins, and therefore the intracellular bioavailability of methotrexate. Also, the expression levels of hENT1 and dCK will be evaluated, since such genes codify for citarabine intracellular transport and activation, respectively. Clinical characteristics will be tabulated and analyzed for responders \& non-responders patients. Uni- \& multivariate analysis will be done to evaluate factors influencing on response and survival.


Eligibility Criteria:
Inclusion Criteria:

* Age: older than 15 years.
* Male, female.
* Normal renal \& liver functions.
* Without previous treatment.
* Candidate to be treated with hyperCVAD Schema (ALL patients).
* Candidate to receive induction remission with cytarabine (AML patients)

Exclusion Criteria:

* Patients not candidate to receive methotrexate or cytarabine.
Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease

This clinical study is a double-blind, randomized, placebo-controlled trial to investigate the effects of melatonin on the sleep disturbance symptoms of Parkinson's disease patients, symptoms which have a significant impact on the quality of life of these patients.

After selecting patients who satisfied the inclusion criteria and were not disqualified by the exclusion criteria, through a double-blind procedure the patients are directed to orally take either the investigational drug melatonin or a placebo(allocation ratio 1:1) for 4 weeks, once daily, before going to sleep. The evaluation of efficacy and safety is performed at the first baseline and immediately after administering the drug for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who meet the clinical criteria for idiopathic Parkinson's disease (United Kingdom Parkinson's Disease Brain Bank Criteria)
2. Patients who complain of sleep disturbances such as insomnia, REM sleep behavior disorder, excessive daytime sleepiness (EDS), etc.
3. Patients who have received drug treatment for at least 6 months since their diagnosis
4. Male or female patient aged 55 or older
5. Patients who have given voluntary consent after understanding the content of the clinical trial (in the case of elderly patients aged 70 or older, consent must be received from both the subject and the his or her legal representative)

Exclusion Criteria:

1. Patients with a serious cognitive disorder, behavioral disorder, or mental illness
2. Patients with a serious medical disease

   * Patients who concomitantly suffer from severe renal impairment, convulsions, stomach ulcers, moderate or more severe liver disease
   * Patients with un-controlled high blood pressure or diabetes
3. Patients who have taken another drug under clinical trial within 4 weeks prior to registering for this clinical trial, or patients who are pregnant or breastfeeding
4. Patients who have a history of hypersensitivity to the investigational drug or a drug similar in component or who have had heavy metal poisoning
5. Patients who are taking drugs which could effect on sleep such as rivotril, quetiapine, lexapro, etc.
Observational Study on the Safety and Efficacy of the Medical Product Fructosin.

Fructosin® is a medical device for use in fructose intolerance. In this uncontrolled posdt market clinical follow up (PMCF) study, the safety and efficacy of oral supplementation of Fructosin® in fructose intolerance will be investigated.

The study participants will be informed about the nature and scope of the study during a preliminary examination (screening) and a declaration of consent will be obtained. In addition, it is determined whether fructose intolerance is present. This is determined by means of the aCPQ test. Subsequently, the patients fill out symptom questionnaires (IBS-SSS, IBS-QoL, 1-week symptom questionnaire).

After the eligibility check, a 14-day phase of monitoring and documentation of symptoms and complaints without taking Fructosin® (observation phase) takes place. At visit 1, the patients receive the Fructosin® capsules, which they take as needed, but no more than 2 x 3 times a day with fruit meals. The intake phase runs over a period of 28 days (4 weeks) during which the study participants observe and evaluate gastrointestinal symptoms with the help of the 1-weekly symptom questionnaire. In addition, the daily fructose consumption (fruit, fruit juices, smoothies) and the amount of Fructosin® capsules taken are documented in a diary.


Eligibility Criteria:
Inclusion Criteria:

* Positive result of the aCPQ test after 25 g fructose ingestion.
* Age: 18 - 80 years; 18 years of age must be completed and the legal capacity must be given.

Exclusion Criteria:

* Pregnancy and breastfeeding
* Congenital (hereditary) fructose intolerance
* Participation in a clinical trial in the past 4 weeks
* At the investigator's discretion: physical findings or previous illness for which a recommendation to take fructosin is not indicated or for which an assessment of the questionnaire by the patient is not possible.
A 4 Week Study of Elidel (Pimecrolimus) for the Treatment of Seborrheic Dermatitis

This is an exploratory study to determine effectiveness of Elidel for the treatment of seborrheic dermatitis

This is a 4 week study for patients 18 and older to compare the efficacy and safety of pimecrolimus cream 1% twice daily and ketaconazole cream 2 % twice daily for the treatment of seborrheic dermatitis.

Eligibility Criteria:
Inclusion Criteria:

* Must be 18 or older and sign written informed consent.
* Must be wiling and able to comply with protocol.
* Must have active seborrheic dermatitis of the face.

Exclusion Criteria:

* No history of overt bacterial, viral or fungal infection of the head/neck.
* No history or presence of compromising dermatosis elsewhere on the skin
* No Parkinson's disease, HIV, infections or disorders of the central nervous system
* No actinically damaged skin
Nexus Compliance Study

Obstructive sleep apnoea (OSA) is characterised by a partial or complete collapse of the upper airway during sleep. The treatment of choice for OSA is Continuous Positive Airway Pressure (CPAP). CPAP acts as a positive airway splint, delivering a fixed positive airway pressure to the upper airway via a tube and mask. Humidification is used during CPAP therapy to improve the comfort of the delivered air and to alleviate nasal dryness/congestion.

The latest design of a CPAP device, known as Nexus (S9), encompasses new features including an improved humidification system (heated tube and climate control), reduced noise, improved comfort of breathing, and a new user interface.

This study will assess whether compliance on CPAP therapy is improved on the Nexus (S9) CPAP, and will assess the usability of the Nexus (S9) CPAP

Obstructive Sleep Apnoea (OSA) is a condition characterised by the partial or complete collapse of the upper airway during sleep. OSA comprises a continuous spectrum of severity ranging from simple snoring and upper airway resistance through mild to severe symptomatic obstructive hypopnoea and apnoea. The prevalence of sleep disordered breathing in the adult population is 24% males and 9% for females. The prevalence of symptomatic OSA in the adult population has been estimated to be 4% in males and 2% in females. These patients demonstrate behavioural and neuropsychological consequences to varying degrees, including excessive daytime sleepiness, intellectual deterioration and depression. More serious consequences include arterial systemic hypertension, arterial pulmonary hypertension and heart disease.

The treatment of choice for OSA is Continuous Positive Airway Pressure (CPAP). CPAP acts as a positive airway splint, delivering a fixed positive airway pressure to the upper airway via a tube and mask. Humidification is used during CPAP therapy to improve comfort of the delivered air and alleviate nasal dryness/congestion.

Compliance with CPAP is a known issue which is affected by many things, including negative side effects and issues with the equipment. The most common complaints involve nasal dryness/congestion and noise from the machine.

The purpose of this study is to assess whether the improved humidification system, reduced noise, improved comfort of breathing and new user interface on the Nexus (S9) CPAP will improve compliance.

Aims:

1. To determine if compliance on the new Nexus (S9) CPAP is improved over the patient's usual CPAP
2. To assess the usability of the Nexus (S9) CPAP.

Eligibility Criteria:
Inclusion Criteria:

* Willingness to provide written informed consent
* Patients who are using a ResMed mask system
* Patients who are at least 18 years of age
* Patients who use a ResMed CPAP device

Exclusion Criteria:

* Patients currently using Bilevel PAP
* Patients who are pregnant
* Patients who the researcher believes are unsuitable for inclusion because either:

  * they do not comprehend English
  * they are unable to provide written informed consent
  * they are physically unable to comply with the protocol
Safety Assessment of T4090 Eye Drops in Ocular Hypertensive or Glaucomatous Patients.

The study purpose is to evaluate the safety of T4090.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent dated and signed.
* Both eyes diagnosed open-angle glaucoma or ocular hypertension

Exclusion Criteria:

* History of trauma, infection, clinically significant inflammation within the previous 6 months
* Known or suspected hypersensitivity to one of the components of the Investigational Medicinal Product(s)
* Pregnancy or breast-feeding
Study on the Myocardial Protective Effect of Upper Limb Ischemic Preconditioning in Patients Undergoing Off-pump Coronary Artery Bypass Grafting

The purpose of the study was to verify the myocardial protective effect of RIPC in patients undergoing OPCABG.

66 patients scheduled for OPCABG are randomly assigned to a RIPC group(n=33) or a control group(n=33). In the RIPC group, 4 cycles of 5-min ischemia(using a blood pressure cuff inflated to 40mmHg over the patient's basic blood pressure) and 5-min repercussion are done on an upper limb before skin incision. Patients in the control group wear the same cuff on an upper limb but no pressure is applied. Anesthetic and surgical techniques are standardized during the trial. Serum inflammatory cytokines and cardiac injury markers will be measured before and after surgery. Internal mammary artery and saphenous vein tissues will be collected during the surgery to assess hypoxia-inducible factor (Hif)-1a and other signalling proteins.

Eligibility Criteria:
Inclusion Criteria:

* serious changes in several coronary arteries that need to receive OPCABG
* NHYA II-III
* ASA II-III

Exclusion Criteria:

* LVEF\< 35%
* acute myocardial infarction
* multiple organ dysfunction
Efficacy Of A PVP-I Fluoride Varnish

The purpose of the study is to determine the efficacy of Advantage Anti-Caries Varnish. Single-center, double-blind, controlled Phase 2 study with parallel groups of children. Subjects will be stratified by early childhood education center and then randomized to receive either test varnish or control varnish topically to the teeth. Treatment will be administered quarterly for up to 24 months. The primary outcome is surface-level primary molar caries increment (d2-4mfs) at 24- months post baseline.

Objectives:

Primary

- To determine if Advantage Anti-Caries Varnish (test varnish) is superior to a control varnish containing only fluoride in the prevention of new caries lesions.

Secondary

* To establish that the response of child participants to the test varnish was not inferior to the control varnish

Eligibility Criteria:
Inclusion Criteria:

1. The subject's parent or legal guardian must provide signed and dated informed consent (parent permission form).
2. The subject's parent or legal guardian of the subject must be willing and able to comply with study requirements.
3. The subject is aged 60-84 months at the time of enrollment.
4. The subject must be in good general health as evidenced by parent report.

Exclusion Criteria:

1. Known allergy to iodine
2. Known allergy to seafood
3. Known hypersensitivity to fluoride varnish
4. Diagnosis of thyroid disease
5. Chronic, prophylactic use of antibiotics
6. Treatment with another investigational drug or other intervention within 30 days preceding the Baseline Visit.
Left Ventricular Function Assessment After Acute Myocardial Infarction: Comparison Between Bi-, Three-dimensional and Cardiac Magnetic Resonance

compare measurements of left ventricular volumes and LVEF obtained by 2DE, 3DE, and CMR after a ST elevation myocardial infarction (STEMI) complicated by systolic left ventricular dysfunction

The assessment of left ventricular ejection fraction (LVEF) is a critical step after a myocardial infarction because it determines the prognosis and the therapeutic management (indication of implantable cardioverter-defibrillators). Three-dimensional echocardiography (3DE) and cardiac magnetic resonance (CMR) are accurate and reproducible techniques to quantify left ventricular volumes and LVEF. However, all the large randomized trials which evaluated the role of the implantable cardioverter-defibrillators (ICD) on survival in primary prevention were based on LVEF values obtained by older techniques like bi-dimensional echocardiography (2DE), angiography or radionuclide scanning. From now, no study has compared the measurements of left ventricular volumes and LVEF obtained by further current techniques after an acute myocardial infarction (AMI) particularly after 1 month when ICD could be indicated.

Eligibility Criteria:
Inclusion Criteria:

* All the patients presenting a first ischemic clinical episode for at least 30 minutes, associated with one known gap will be included in a forward-looking and consecutive way, of at least 0.1mV in at least two peripheral diversions of the same territory or of at least 0.2 mV in at least two precordial diversions of the same territory
* An initial FEVG (measured by echocardiography or ventricular angiography in the daytime of the admittance)

Exclusion Criteria:

* Age \< 18 years
* Antecedents of IDM
* Contraindications in the MRI (claustrophobia, stimulating and defibrillators heart patient implantable, metal intraocular brightness, allergy in the gadolinium, the severe renal insufficiency with clearance in the creatinine ≤30 mL/min)
* Fibrillation little finger
* Pregnancy.
Predictors of Colonoscopy Non-attendance and the Efficacy of a SMS Reminder to Reduce Non-attendance Rate

To conduct a prospective randomized controlled study to identify predictors for colonoscopy non-attendance and examine the efficacy of SMS reminder to improve the non-attendance rate.

Implementation of colorectal screening programs has been shown to decrease, the incidence of colorectal cancer due to the early detection and removal of pre-cancerous colonic polyps. Colonoscopy is therefore one of the most common medical procedures performed in the United States with 14 million procedures performed in 2003. Aside from screening, colonoscopy is also essential for other aspects of colorectal cancer management including post-resection surveillance and palliative treatments. Use of computer simulation models showed that the demand for colonoscopy in the United States exceeds current capacity regardless of screening strategy. The incidence of colorectal cancer has been increasing in Hong Kong and has been associated with progressive increase in the colonoscopy waiting times in the public health care system. The progressive increase in the demand for colonoscopy therefore poses a significant burden on the healthcare systems of all developed countries. Methods to increase the capacity and efficiency of the colonoscopy service are needed.

Non-attendance rates of gastrointestinal endoscopy appointments may range from 12% to 27% 5-6 and results in inefficient use of healthcare resources, delay in diagnosis and an increase in waiting times. Adams et al. conducted a prospective cohort study which showed that younger age, long waiting times and referral from a non-gastroenterologist were significantly associated with non-attendance. In an another prospective cohort study, Sola-Vera et al. also showed that the waiting time and source of referral were independent predictive factors for non-attendance 7. Studies on gynecological endoscopy non-attendance revealed that predictors of non-attendance include unemployment, current smokers, younger age, long follow up periods, lower social class, lower education levels and lack of understanding of the endoscopic procedure 8-10.

Telephone reminders have been used to improve non-attendance rates; Adams et al. had decreased the non-attendance rate from 12.2% to 9% after introduction of telephone reminder 1 week prior to the examination. The Mayo clinic open-access endoscopy system, which incorporates a standard telephone reminder 3-7 days prior to the procedure, has a non-attendance rate of only 4.1%.

Eligibility Criteria:
Inclusion Criteria:

* All patients referred for an outpatient colonoscopy at the Alice Ho Miu Ling Nethersole Hospital Combined Endoscopy Unit

Exclusion Criteria:

* Age ≤ 18
* Lack of informed consent