cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device Compared to BiPAP S/T Device

This study is being undertaken to collect data from Respironics, Inc's BiPAP autoSV3 and compare with data from Respironics, Inc's BiPAP S/T device, to confirm that the algorithms in the BiPAP autoSV3 device can safely and effectively treat participants experiencing Comp SAS no worse than the BiPAP S/T device. This will be determined using a comparative, randomized design with the participants blinded to the therapy. Additionally, attempts will be made to blind the central scorer(s) with respect to which device is in use.

Primary Hypothesis and end-point:

The use of the BiPAP autoSV3 device in participants with Comp SAS will treat those participants no worse than when compared to the BiPAP S/T device with respect to:

* Apnea-Hypopnea Index (AHI)

Secondary Hypothesis and end-points:

The use of the BiPAP autoSV3 device in participants with Comp SAS will treat those participants no worse than the BiPAP S/T device, with respect to:

* Sleep Variables
* REM, NREM and Total Sleep Time (TST) Indices
* Apnea Hypopnea Index (AHI)
* Center Apnea Index(CAI)
* Obstructive Apnea Index (OAI)
* Mixed Apnea Index (MAI)
* Hypopnea Index (HI)
* Sleep Onset Latency (SOL)
* REM Onset Latency (ROL)
* Wake After Sleep Onset (WASO)
* Total Sleep Time (TST)
* Sleep Efficiency (SE %)
* Wake (W), Stages N1,N2,N3 (NREM), and REM (R) sleep (in minutes)
* Wake (W), Stages N1,N2,N3 (NREM), and REM (R) sleep (% TST)
* Arousal Index \[total, AH-related, PLM-related, 'spontaneous'\]
* Nocturnal oxygenation (measured by continuous pulse oximetry during sleep study)
* AHI (REM, NREM and TST) using modified hypopnea rule.
* AHI (REM, NREM and TST) during epochs for which leak is determined to exist within acceptable limits

Eligibility Criteria:
Inclusion Criteria:

* Age 21-80.
* Ability to provide consent.
* Documentation of medical stability by investigator.
* Currently using BiPAP S/T (At least 4 weeks on therapy).
* Participants who previously demonstrated Complex Sleep Apnea (CSA), with a central apnea index (CAI) ≥5 during Diagnosis study or on Positive Airway Pressure (PAP) titration.

Exclusion Criteria:

* Participants, who are acutely ill, medically complicated or who are medically unstable.
* Participants in whom PAP therapy is otherwise medically contraindicated.
* Participants who are unwilling to wear PAP.
* Participants who are currently prescribed oxygen therapy.
* Participants with previously diagnosed respiratory failure or respiratory insufficiency and who are known to have chronically elevated arterial carbon dioxide levels while awake (PaCO2 ≥ 45mmHg).
* Participants who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days.
* Participants with untreated, non-obstructive sleep apnea (OSA)/CSA sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome Periodic Limb Movement (PLM) Arousal Index \> 15).
* Participants who are unwilling to participate in the study.
Effect of Core Stability Excercises Program on Reaching in Children With Cerebral Palsy

Purpose of the study:

To evaluate effect of core stability exercises program on upper limb reaching in children with spastic hemiparetic cerebral palsy.

Thirty spastic hemiparetic cerebral palsied children of both sexes will be selected from General hospitals and private centers in El-Minia government with the following criteria:

1. The age of the selected children ranged from 3 To 6 years old.
2. Degree of spasticity is ranging from 1 to 1+, according to modified Ashworth scale
3. Children in study group will be treated using core stability exercises program in addition to traditional program and children in the control group will be treated using traditional physical therapy program.
4. Trunk control measurement scale and pediatric reach test will be used to evaluate each child individually before and after 6 successive weeks of treatment, three times per week.

Eligibility Criteria:
Inclusion Criteria:

1. The age of the selected children ranged from 3 To 6 years old.
2. Degree of spasticity is ranging from 1 to 1+, according to modified Ashworth scale(Bohannon and Smith, 1987).
3. Children with hemiparetic cerebral palsy

Exclusion Criteria:

1. Fructures and fixed deformities
Improved Sensitivity Detection of Serum HBsAg and HBsAg Reversion

The goal of this observational study is to learn about the HBsAg reversion rate at 48 weeks off treatment in HBsAg-negative patients by HBsAg NEXT assay which has improved sensitivity compared to current ARCHITECT HBsAg Assay.

The main question it aims to answer is:

What's the HBsAg reversion rate at 48 weeks off treatment in HBsAg-negative patients by HBsAg NEXT assay? HBsAg NEXT assay technology (lower limit of detection for HBsAg is 0.005 IU/ml) and current ARCHITECT HBsAg assay (lower limit of detection for HBsAg is 0.05 IU/ml) are applied for HBsAg detection in patients achieving functional cure, and to compare the difference in HBsAg reversion rate 48 weeks off treatment under the two types of criteria.

In this study, chronic hepatitis B patients who achieved HBsAg loss by current ARCHITECT HBsAg testing (lower limit of detection for HBsAg is 0.05 IU/ml) under interferon therapy and received consolidation therapy for 3 month after that were screened for eligibility. Those who are willing to discontinue were enrolled in the study. Patients were divided in two groups according to HBsAg levels，one with patients who were HBsAg-negative （HBsAg\<0.005 IU/mL）by HBsAg next assay , and the other with patients who had HBsAg levels between 0.005 IU/mL and 0.05IU/mL. Patients were followed up for 48 weeks after discontinuation after HBsAg loss and HBsAg reversion rates in the two groups were analyzed and compared.

Eligibility Criteria:
Inclusion Criteria:

* HBsAg-negative by Abbott's HBsAg Test and HBeAg-negative;
* Having serum specimens retained at baseline and at 48 weeks off treatment follow up;
* Being willing to follow up regularly for 1 year.

Exclusion Criteria:

* Patients with hepatitis B cirrhosis in the compensated and decompensated stages: this includes patients with a clear history of cirrhosis (imaging or histological evidence) or Child-Pugh score ≥5 prior to NUC treatment, or who have had complications of the decompensated stage of cirrhosis, such as ascites, hepatic encephalopathy, or ruptured oesophago-gastric fundal varices bleeding;
* Combined HAV, HCV, HDV, HEV, HIV infections, alcoholic liver disease, inherited metabolic liver disease, pharmacological liver disease, non-alcoholic fatty liver disease, autoimmune liver disease and other chronic liver diseases;
* Primary hepatocellular carcinoma or those with AFP greater than 100 ng/ml at screening and imaging suggestive of possible malignant hepatic occupancy; or patients with AFP greater than 100 ng/ml for a sustained period of 3 months;
* Patients with a combination of other malignant tumours (excluding those who have been cured);
* Patients with severe diseases or uncontrolled disease
* Those who are also participating in other clinical studies;
* Patients deemed unsuitable by the investigator to participate in this study.
Ontogenesis of the P-Glycoprotein in Human Lymphocytes Influence of HIV and Antiretroviral Therapeutics

The P-glycoprotein (P-gp) is a membranous transporter that modulates the intracellular concentrations of many drugs and plays thus a major role in the efficacy of the therapeutics that act within the lymphocytes, such as antiretroviral drugs. We aim at studying the evolution of this transporter's expression and activity on lymphocytes in relation with the human development from newborns to adults. We also aim at studying the influence of HIV and antiretroviral treatments on this transporter, especially anti-protease drugs, within the children population.

Several groups of drugs involved in the treatment of major pathologies act within the lymphocyte, such as anticancer, immunosuppressive and antiretroviral drugs. These molecules depend on membranous transporters to get inside the lymphocyte and be effective. Among those transporters, the P-glycoprotein (P-gp) plays a major role, especially because of the variety of its substrates among therapeutic molecules. Its expression and activity are well known within the adult population, as well as its modulations mediated by certain groups of drugs, such as protease inhibitors in the treatment of HIV. Yet, there is very little data on children, even though they are exposed to the same therapeutic molecules as the adults. Therefore, we aim at studying the evolution of this transporter's expression and activity on the different lymphocyte populations, in relation to the human development from newborns to adults. We also aim at studying the influence of HIV and antiretroviral treatments on this transporter, especially anti-protease drugs, within the children population. P-gp activity is quantified by flow cytometry, through the efflux of a fluorescent substrate, in the presence or absence of a P-gp inhibitor. P-gp expression is measured on isolated motonucleus cells with the quantification of mRNA encoded for the transporter by RT-PCR (Reverse Transcription - Polymerase Chain Reaction). Patients of every age, from newborns to adults, are recruited within eight different age groups and three HIV status groups (HIV non infected, HIV infected untreated, HIV infected treated). The objective is to recruit ten patients in each age group for each HIV status. Blood samples are obtained from hospitalized children and adults with their consent. The patients will be recruited for one year. Our objective is to determine whether the P-gp expression and/or activity are influenced by age, HIV status and antiretroviral treatments, in order to prevent, depending on developmental stages, ineffectiveness or toxicity due to inadequate intracellular concentrations.

After the first evaluations, principal investigators decided to add one year more for three groups on eight.

For two groups of these three, genetic polymorphism of Mdr1 will be done.

Eligibility Criteria:
Inclusion Criteria:

* age, HIV status

Exclusion Criteria:

* None
BI 836826 Dose Escalation in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma (NHL)

The purpose is to investigate the maximum tolerated dose (MTD), safety and tolerability, pharmacokinetics and efficacy of BI 836826 monotherapy in patients with relapsed or refractory non-Hodgkin lymphoma with at least prior treatments.


Eligibility Criteria:
Inclusion criteria:

1. Patients with relapsed or refractory non-Hodgkin lymphoma of B cell origin (mature B cell lymphoma according to WHO) not considered candidates for intensive anti-lymphoma therapy
2. Patients must have either aggressive NHL and received at least one prior anti-CD20 containing immunochemotherapy or indolent NHL and received anti-CD20 therapy and at least two prior therapies
3. Measurable disease on computed tomography (CT) scan with involvement of one clearly demarcated lesion =2 cm or two or more clearly demarcated lesions of \>1.5 cm at longest diameter (this criterion applies only for the expansion cohort)
4. Relapse or progression of disease with an indication for therapy as per investigator's judgement
5. Life expectancy of =3 months
6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

Exclusion criteria:

1. Primary central nervous system (CNS) lymphoma or known CNS involvement
2. Prior history of malignancy other than a mature B cell neoplasm according to WHO classification (except basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the uterine cervix or breast treated with curative therapy) unless the subject has been free of disease and without treatment for at least 5 years
3. Last chemotherapy \<4 weeks prior to visit 1
4. Last anti-CD20 therapy (non-radiolabelled) \<4 weeks prior to visit 1
5. Last corticosteroid \<2 weeks prior to visit 1 unless the dose is less or equal of 10 mg/day prednisolone or equivalent
6. High-dose therapy with stem cell support \<6 months prior to visit 1
7. Radio-immunotherapy \<3 months prior to visit 1
Effect of an Investigational Multi-Purpose Solution on Lens Moisture

The purpose of the study is to evaluate the effect of an investigational multi-purpose disinfecting solution (MPDS) compared to a marketed multi-purpose solution on the moisture of silicone hydrogel contact lenses.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* Wears silicone hydrogel contact lenses on a daily wear basis i.e. disinfects lenses every night).
* Has successfully worn contact lenses for 5 days, 8 hours per day, prior to baseline visit.
* Vision is correctable to 20/30 or better in each eye at distance with study lenses at baseline visit.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Known sensitivity or intolerance to contact lens multi-purpose solutions.
* Use of any topical ocular OTC or prescribed topical ocular medications.
* History or current ocular infections or ocular inflammatory events.
* Ocular surgery within the past year.
* Medical condition or use of medication that cause ocular side effects.
* Participation in any investigational study within the past 30 days.
* Other protocol-defined exclusion criteria may apply.
A Study Of Different Doses Of TBC3711 In Patients With Uncontrolled High Blood Pressure Already Taking Medications For High Blood Pressure.

The study was to determine the safe and effective dose of TBC3711 in patients with uncontrolled high blood pressure while already taking blood pressure medications.

The study was stopped due to Pfizer (sponsor) decision that the compound would not be involved in any further clinical development for the indication of resistant hypertension on 05 August 2008. This decision was not based on any safety or efficacy concern.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of resistant hypertension.
* A stable anti-hypertensive drug regimen for at least 30 days.

Exclusion Criteria:

* Sustained blood pressure greater than or equal to 180/120 mmHg.
* Required use of thigh cuff for blood pressure readings.
* Uncontrolled diabetes mellitus.
Efficacy Comparison Between Different Management Strategies for Consistent OAB in Patients With SVMs After Surgery

The investigators' goal is to compare the efficacy of three different management strategies (sacral neuromodulation, botulinum toxin, M receptor antagonist) in treating consistent OAB in patients with SVMs after surgery.

Spinal Vascular malformations (SVMs) are complex neurosurgical lesions and account for 3%-4% of all intradural spinal cord mass lesions, which can influence the function of bladder. The investigators' goal is to compare the efficacy of three different management strategies (sacral neuromodulation, botulinum toxin, M receptor antagonist) in treating consistent OAB (Overactive Bladder) in patients with SVMs after surgery.

Eligibility Criteria:
Inclusion Criteria:

* •Patient diagnosed with spinal vascular diseases including Intradural arteriovenous malformation,Intradural arteriovenous fistula,Dural arteriovenous fistula,Extradural arteriovenous malformation,Paravertebral arteriovenous malformation,Paravertebral arteriovenous fistula,cobbs' syndrome,and other spinal arteriovenous metameric syndromes involve the spinal cord.

  * patient not received surgical or interventional treatment before
  * patient with normal cardiac, renal and hepatic function
  * patient capable of understanding the content of the patient information / Informed Consent Form
  * patient willing and able to participate in the registry
  * patients have consistent OAB after surgery

Exclusion Criteria:

* •patient received surgical treatment or interventional treatment before

  * patient is pregnant
  * patient allergic to iodine
  * patient unable to complete follow-up
  * patient with cerebral lesions
  * patient with other spinal lesions
  * patient with cardiac, renal or hepatic dysfunction
Non-Invasive Chromosomal Evaluation of 22q11.2

This study is being conducted to develop and evaluate a cell-free fetal DNA test (Harmony) for non-invasive prenatal detection of 22q11.2 chromosomal deletion or duplication.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is ≥18 years of age and able to provide consent or, if under the age of 18, the patient has parental consent and child assent provided as required by the governing ethics committee.
2. If pregnant, patients must have a singleton pregnancy and be at least 10 weeks gestation at the time of the study blood draw.
3. Patients must meet at least one of the following conditions at the time of enrollment:

   1. are pregnant with abnormal fetal cardiac findings on ultrasound and is undergoing evaluation with prenatal genetic testing or planned post-natal genetic testing in the immediate newborn period;
   2. are pregnant with fetal ultrasound findings consistent with a 22q11.2 deletion/duplication phenotype and is undergoing evaluation with prenatal genetic testing or planned post-natal genetic testing in the immediate newborn period;
   3. are pregnant with a fetus known to have a 22q11.2 deletion/duplication confirmed by genetic testing with documentation is available;
   4. are biologically related parent of an enrolled child has chromosomal deletion/duplication in the region of 22q11.2;
4. If the site is selected to enroll control patients, they must be pregnant women undergoing prenatal genetic evaluation for 22q11.2 deletion/duplication.

Exclusion Criteria

Patients meeting any of the following criteria will be excluded from the study:

1. Patient has history of malignancy treated with chemotherapy and/or major surgery, or bone marrow transplant.
Effectiveness of Text Messaging Intervention to Improve Dietary Behaviors Among Patients with Type 2 Diabetes Mellitus in Low Resource Area of Sabah (DTEXT-SBH)

The goal of this clinical trial is to learn if sending three (3) text messages per week over a six (6) months period to people with Type 2 Diabetes in areas with lack access to dietitian could help them stick to a healthier diet. The main questions it aims to answer are:

* Does a mobile phone text-message intervention improve dietary adherence among T2DM patients?
* Does a mobile phone text-message intervention improve HbA1c and self-management among T2DM patients? Researchers will compare dietary adherence, HbA1c changes and self-management behaviors between the usual care group and intervention group.

Participants will:

* Be given three (3) text messages per week over a six (6) months period for the intervention group
* Both usual care and intervention group will be given standard medical nutrition therapy at baseline, 3rd and 6th months visits to the clinic


Eligibility Criteria:
Inclusion Criteria:

* have type 2 diabetes.
* own a mobile phone.
* able to use WhatsApp.
* able to read and speak Bahasa Malaysia.
* have an HbA1c level above 7.0%.
* have not seen a dietitian in the previous 6 months.

Exclusion Criteria:

* individuals with type 1 diabetes mellitus and gestational diabetes mellitus.
* patients with cognitive impairment affecting memory, attention, language, and problem-solving skills.
* those with advanced diabetic complications, such as kidney failure and neuropathy.
* individuals lacking regular access to a mobile phone or with poor network connectivity.
* pregnant individuals or those planning to get pregnant in the next 6 months, as well as those currently nursing.
* individuals with major illnesses like cancer or advanced heart disease.
* those planning major surgery or gastric bypass in the next 6 months.
* institutionalized individuals, such as those in nursing homes, old folks\&#39; homes, or imprisoned.
Fractional Exhaled Nitric Oxide (FeNO) Result Prediction Factors in Children With Allergic Diseases

In about 800 children with allergic diseases (asthma, allergic rhinitis, atopic dermatitis) the investigators will retrospectively and cross-sectionally analyze the influence/correlation of diagnosis, treatment methods, allergy status (skin prick test results), lung function tests results on/with the concentration of nitric oxide in exhaled breath.

In about 800 children with allergic diseases from our Outpatient Clinic (asthma, allergic rhinitis, atopic dermatitis) we will retrospectively and cross-sectionally analyse the influence/correlation of diagnosis, treatment methods, allergy status (skin prick test results), lung function tests results on/with the concentration of nitric oxide in exhaled breath.

Eligibility Criteria:
Inclusion Criteria:

* Children with asthma (allergic), and/or allergic rhinitis and/or atopic dermatitis

Exclusion Criteria:

* Other chronic diseases
* Asthma exacerbation
* Pregnancy
Effectiveness of Children Experiencing Nitrous Oxide/Oxygen Inhalation Sedation at an Assessment Visit Before Having Treatment.

The purpose of this study is to find out the effect of experience of dental sedation at assessment on children's anxiety before the actual treatment session.

Title: Effectiveness of children experiencing nitrous oxide/oxygen inhalation sedation at an assessment visit before having treatment.

Background: Dental anxiety is a common problem, affecting people of all ages, but predominantly children and adolescents. Inhalation sedation (IHS) using nitrous oxide/oxygen (N2O/O2) mixture is a pharmacological behaviour management technique that is widely used to manage dental anxiety in children. It is suggested that the use of an acclimatisation would increase the acceptability and the efficacy of N2O/O2 success. Even though the introductory appointment has been widely proposed, there have not been any studies conducted to measure the effectiveness of this appointment in improving the success of N2O/O2 sedation in children.

Aims: This study aimed to investigate the effect of experience of nitrous oxide/oxygen sedation at assessment prior to dental inhalation sedation on children's anxiety.

Methods: The study was a parallel randomised non blinded control clinical trial. Children aged five to fifteen years who were seen at the Leeds Dental Institute for dental treatment under inhalation sedation were recruited on the assessment appointment (1st visit). Both two groups received an assessment appointment, however participants of the study group tried on the mask and the nitrous oxide/oxygen sedation while the ones of the control group tried on the mask without the nitrous oxide/oxygen sedation. Following the assessment appointment, both groups received a second appointment for treatment. Dental anxiety was measured through two different methods. Primarily through the MCDASf questionnaire, which was completed once at the beginning of the assessment visit and twice at the beginning and end of the treatment visit. Secondarily anxiety was measured though the E4 wristband which participants of both groups wore throughout both appointments and recorded their Heart Rate (HR) and Skin Temperature (ST). At the end of the treatment visit, participants and their parents/legal guardians were asked to complete a feedback questionnaire related to the E4 wristband and the experience of N2O/O2 sedation at the assessment visit.

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Eligibility Criteria:
Inclusion Criteria:

Patients attending the Sedation Unit for dental treatment under inhalation sedation.

* Children aged 5 to 15 years.
* ASA Class I or II.
* First time having inhalation sedation.

Exclusion Criteria:

* Participants who refuse to wear the mask.

  * Language barriers where no interpreter was available
  * Parents/Carer who refused to sign consent or children who did not assent.