cyrilzakka/clinical-trials huggingface dataset:
NEIVATECH Virtual Reality-based System for Amblyopia

The NEIVATECH system has been designed to provide binocular vision training to 7-15 year old amblyopic children by discriminating Gabor patches presented with different contrast to each eye as a perceptual learning task.

Due to the global impact of amblyopia, there is a medical and social need, and at the same time, a clear market niche, for the design and development of new therapies that can improve recurrence rates and non-compliance with conventional treatments. In this sense, the aim of this single-arm, multicentre, prospective pilot study is to examine the safety, acceptability and clinical efficacy of a novel Virtual Reality-based system designed to provide binocular vision training to 7-15 year old amblyopic children complementing the concepts of perceptual learning and dichoptic training with a gamification approach.

Eligibility Criteria:
Inclusion Criteria:

* Children aged between 7 and 15 years.
* VA in the amblyopic eye \< 0.1 logMAR units.
* Interocular difference in VA ≥ 1 logMAR line.
* Interocular difference in espherical equivalent ≥ 1 D.
* Interpupillary distance (IPD) between 60.7 and 73.5 mm.
* Use of best refractive correction for at least 2 months prior to inclusion.
* Lack of response or therapeutic adherence to conventional occlusion therapy.
* Willingness to attend all the active vision therapy sessions and/or visits of the study.
* No history of previous treatment for amblyopia other than optimal refractive correction for at least 2 months prior to inclusion.

Exclusion Criteria:

* Active eye disease.
* Previous ocular surgery.
* BCVA in the amblyopic eye of ≥ 0.70 logMAR.
* Presence of cognitive impairment or neurological or psychiatric disorders.
* Presence of irregular cornea due to astigmatism or ectatic corneal disease.
An Open-Label, Non-Randomized Trial to Evaluate the Tolerability and Safety of Viramune (Nevirapine) in Adult and Pediatric Patients With Progressive HIV Disease

To provide access to Viramune and to evaluate the tolerance and safety of Viramune in patients with progressive, symptomatic HIV disease who failed or are intolerant to currently approved treatment for HIV-1 infection and who are unable to participate in another Viramune controlled clinical trial and have a compelling need for anti-HIV treatment.

Eligible adult patients (\>= 13 years of age) will receive treatment with Viramune once daily for 2 weeks and then twice daily. Eligible pediatric patients (\< 13 years of age) will receive a lower dose of Viramune once daily for 2 weeks and then twice daily. All patients will receive Viramune with or without concomitant antiretroviral therapy. Patients will be evaluated at weeks 2, 4, 8, 16, 24, 32 and every 8 weeks thereafter.

PER AMENDMENT 01/31/97: Enrollment closed to adult patients. As of 1/31/97 only enrolling pediatric patients.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Patients \> 18 months of age with history of positive serology for HIV-1 infection or patients \<= 18 months of age with history of positive viral culture, detectable p24 antigen, or positive peripheral blood mononuclear cell macro culture.
* Patients \>= 13 years of age with a CD4+ cell count \<= 200 cells/mm3. Patients \< 13 years of age with a CD4% \<= 14% or a 50% decrease in CD4% in the past 6 months if the previous CD4% was \>=20%.
* Patient has failed or is intolerant to currently approved treatments for HIV-1 infection and is unable to participate in a controlled viramune clinical trial.
* Written and informed consent from a parent or guardian for patients \< 18 years of age.
* Patient or guardian is willing and able to follow protocol requirements. (PER AMENDMENT 1/29/97:
* Enrollment is closed to adults, as of Jan. 29th only pediatric patients will be enrolled.)

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

Patient qualifies for participation in an actively accruing Viramune controlled clinical trial.

Concurrent Medication:

Excluded:

* Dicumarol, Warfarin, and other anticoagulant medications.
* Tolbutamide.
* Investigational drugs, all protease inhibitors, and all other non-nucleoside transcriptase inhibitors.
* Neurotoxic drugs.
* Cimetidine.
* Erythromycin.

Required:

Patient has failed or is intolerant to currently approved treatments for HIV-1 infection.
Efficacy and Safety Study of Fluticasone/Salmeterol Administered With Elpenhaler

The aim of this study is to establish the therapeutic equivalence between the test (Fluticasone/Salmeterol administered with Elpenhaler®db, Rolenium®) and the reference formulation (Seretide®, administered with Diskus®), both containing 250/50μg of the Fluticasone/Salmeterol combination.

In case of inhaled products, it is not possible to follow the classic scheme, based on similarity of plasma concentration-time behavior of parent drug in assessing bioequivalence.

A pharmacodynamic study was designed in order to assess the therapeutic equivalence of the new formulation of Fluticasone/Salmeterol with the innovative one. The test and reference Fluticasone/Salmeterol formulations will be compared in terms of their bronchodilator effects in lung function. Forced Expiratory Volume in 1 second (FEV1) will be the primary efficacy measure and will be measured in such a way that a similar time-dependent increase in pulmonary function can be demonstrated for both Fluticasone/Salmeterol formulations in patients with asthma. In terms of safety comparison, repeated measurements of adverse events, vital signs, heart rate, blood hematology and biochemistry as well as ECG changes will enable the establishment of the similar safety profile of the test and reference Fluticasone/Salmeterol combinations.

The study will be conducted in a randomized, double-blind, double-dummy, placebo-controlled, 3x3 crossover fashion.

Eligibility Criteria:
Inclusion Criteria:

* age 18-65 years,
* diagnosis of asthma of 6 months,
* FEV1 ≥ 50% and ≤ 80% predicted, reversibility of at least 12%,
* stable asthma for at least 4 weeks,
* inhaled steroids (ICS) at a stable dose within the previous 30 days,
* PIF 30 - 90 lt/min and
* informed consent.

Exclusion Criteria:

* history of other pulmonary disease, asthma exacerbation or respiratory infection within the previous 4 weeks,
* hospitalization for acute asthmatic symptoms requiring parenteral steroids or oral steroid dose increase within the previous 30 days,
* heavy smokers,
* change of asthma medication within the previous 4 weeks, seasonal asthma alone,
* history of severe heart disease,
* pregnancy or lactation,
* use of a β-blocker, of a NSAID or an antiallergic/antihistaminic medication within 2 weeks prior to screening visit.
Mindfulness-based "STOP (Stop, Take a Breath, Observe, Proceed) Touching Your Face" Intervention

This single-blind, randomized, controlled, trial is to assess the efficasy of a brief mindfulness-based "STOP touching your face" training program to reduce or avoid face-touching to low people's chances of catching infectious diseases like COVID-19.

Background Face-touching behavior often happens frequently and automatically, and poses potential risk for spreading infectious disease. Mindfulness-based interventions (MBIs) have shown its efficacy in the treatment of behavior disorders. This study aims to evaluate an online mindfulness-based brief intervention skill named "STOP (Stop, Take a Breath, Observe, Proceed) touching your face" in reducing face-touching behavior.

Methods This will be a single-blind, randomized, controlled, trial. We will recruit 1,000 participants, and will randomize and allocate participants 1:1 to the "STOP touching your face" intervention group (n=500) and the control group (n=500). All participants will be asked to monitor and record their face-touching behavior. The intervention group will receive the brief online mindfulness-based "STOP touching your face" program, and the control group will receive control intervention. Primary outcome will be the efficacy of short-term mindfulness-based "STOP touching your face" intervention for reducing the frequency of face-touching. The secondary outcomes will be the reduction of the duration of face-touching after intervention; the correlation between the psychological traits of mindfulness and face-touching behavior; and the differences of face-touching behavior between left-handers and right-handers. We will recruit 1000 participants from April to June 2020 or until the recruitment process is complete. The follow-up will be completed in June 2020. We expect all trial results to be available by the end of June 2020.

Discussion This is the first RCT to evaluate the efficacy of brief mindfulness intervention to reduce face-touching behavior. We expect that "STOP touching your face" has a significantly greater reduction the frequency of face-touching behavior than the control intervention. As "STOP touching your face" is a brief and simple skill, the public health impact of its expansion world-wide could be enormous, helping us to manage any face-touching spread infectious diseases, like Coronavirus disease 2019 (COVID-19).

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Being able to access online services
3. Being able to read and write in Chinese
4. Expressing an interest in participant this study
5. Willing to provide informed consent to participate in the study

Exclusion Criteria:

1. Under 18 years of age
2. Unable to access online services
3. Unable to read and write in Chinese
Effect of Medicago Sativa on Oral Glucose Tolerance in Healthy Adults

Previous preclinical investigations have found that Medicago sativa promotes the decrease of glucose concentrations. To evaluate the acute effect of Medicago sativa administration on glucose tolerance, insulin secretion, and insulin sensitivity in healthy individuals.

A randomized, double-blind, placebo-controlled, two-period, cross-over clinical trail will be carrie out in 15 healthy, sedentary individuals of both genders, who meet the following inclusion criteria: 25 to 40 years of age, normal fasting plasma glucose (≤ 5.5 mm/L), blood pressure (\<130/90 mmHg), body mass index of 25 to 29.9 kg/m2, no taking any medication known to affect glucose tolerance, nondrinkers and nonsmokers. No pregnant, and lactation estate for female participants. They will be select from the same neighborhood and socioeconomic status.

After a fasting blood sample patients will be assigned at random-order through a closed-envelope selection, to receive one of two possible sequences during which they received either single oral doses of Medicago sativa or homologated placebo in 1,500 mg and were crossover with a difference of at least 7 days washout interval. Thirty minutes after each intervention patients underwent a 75-g oral glucose tolerant test (OGTT). Area under the curve of glucose and insulin, phases of insulin secretion, and insulin sensitivity will be calculate for each treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Fasting plasma glucose ≤99 mg/dL.
* Two hours postload plasma glucose (100 a 139 mg/dL).
* Body mass Index: 25 -39.9 kg/m2.
* body weight stable over the last 3 months.
* Women in follicular phase of the menstrual cycle (days 3 to 8 of the cycle) at the time of laboratory tests.
* Sedentary.
* Nonsmokers.
* Body weight unchanged upper to 5% for at least 3 moths before the study.

Exclusion Criteria:

* Women in pregnancy and/or breastfeeding
* Physical or mental disability that makes it impossible to perform the intervention.
* Diagnosis of hypertension or heart failure.
* Untreated thyroid disease.
* Consumption of oral agents or other medications or supplements with proven properties that modify the behavior of glucose and lipids (oral hypoglycemic agents, insulin, lipid-lowering).
* Diagnosis of liver disease or elevation twice of the upper normal value of liver enzymes.
* Diagnosis of renal disease or creatinine \>1.5 mg/dL.
* Diagnosis of prediabetes: Fasting plasma glucose ≥100 mg/dL and/or 2h-OGTT ≥140mg/dL and/or glycated hemoglobin A1c (A1C) between 5.7 - 6-4 %.
* Diagnosis of Type 2 Diabetes Mellitus (T2DM): Fasting glucose ≥ 126 mg / dL and/or 2h-OGTT ≥ 200 mg/dL .
* Total Cholesterol ≥ 280 mg/dL.
* Triglycerides ≥ 300 mg/dL.
* Known allergy to calcined magnesia or Medicago sativa.
CATCH-R: A Rollover Study to Provide Continued Access to Rucaparib

This protocol is designed to provide participants currently benefiting from rucaparib treatment in a Clovis-sponsored clinical study with continued access to treatment for as long as they continue to benefit. Participants in long-term follow-up (LTFU) in a parent study may also enroll in this study for continued data collection, as applicable based on parent study objectives.

Participants enrolled in this study are required to have completed an End-of-Treatment (EOT) Visit with associated assessments as specified in the Clovis-sponsored parent study (NCT01891344; NCT01968213; NCT02855944). Participants who are no longer receiving treatment and are in LTFU in the parent study (NCT02855944) may enroll into the LTFU portion of this study, as applicable based on parent study objectives, without repeating the EOT visit.

The starting dose of rucaparib administered at initiation of this study will be the same as the last dose received in the parent study, or as deemed appropriate by the investigator and based on available dose strength tablets. The first treatment in the rollover study will begin at the next scheduled treatment visit following the EOT Visit in the parent study.

Participants enrolled to receive continued rucaparib may be treated until disease progression, as assessed by the investigator, unacceptable toxicity, withdrawal of consent, death, loss to follow-up, or study closure by the sponsor. If a participant demonstrates disease progression per investigator assessment while receiving treatment with rucaparib but continues to derive clinical benefit, then continuation of treatment beyond progression is permitted based on investigator decision and participant consent. If a participant continues treatment post-progression, all study assessments should be continued per institutional standard of care. The participant should be discontinued from treatment once it is clear that no further clinical benefit can be achieved.

Eligibility Criteria:
Inclusion Criteria:

* Currently enrolled in a Clovis-sponsored study of rucaparib that is being closed
* Either: (a) Is currently tolerating a rucaparib treatment regimen in the parent study with evidence of clinical benefit, as assessed by the investigator, or (b) Has discontinued treatment and is being followed for collection of LTFU data in the parent study
* Demonstrated compliance with the parent study requirements, as assessed by the investigator, and participant is able and willing to comply with the necessary study visits and assessments as part of the rollover study
* Provided written informed consent prior to enrolling in this rollover study

Exclusion Criteria (applicable only to participants considered for continuation of rucaparib treatment):

* Participant has been permanently discontinued from study treatment in the parent study for any reason
* Pregnant or breastfeeding female patients
* Presence of any other condition that may, in the opinion of the investigator, make the participant inappropriate for continuation of rucaparib treatment.
Patients With Low-Grade Non-Hodgkin's Lymphoma Previously Treated With Tositumomab and/or Iodine I 131 Tositumomab

This is a study for the long-term follow-up of patients who completed at least two years of follow-up after treatment with Tositumomab and/or Iodine I 131 Tositumomab (BEXXAR)on Study RIT-I-000, RIT-II-001, RIT-II-002, RIT-II-004 or CP-97-012. All patients will be assessed for survival and disease status, including subsequent therapy for NHL, and for long term safety. Laboratory evaluations consisting of a TSH level (for all patients) and a complete blood cell (CBC) count with a differential and platelet count (for patients in continuing response only) will be obtained annually through Year 10 post treatment with Tositumomab and/or Iodine I 131 Tositumomab.

Patients that remain in response to their previous treatment with BEXXAR, will additionally be followed radiographically for response and progression.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have enrolled in one of the following Corixa sponsored clinical trials: RIT-I-000, RIT-II-001, RIT-II-002, RIT II-004 or CP-97-012 and are \>2 years post Tositumomab and/or Iodine I 131 Tositumomab administration.
* Patients must give written informed consent by signing an IRB/ethics committee approved consent form prior to entry on this follow-up study.

Exclusion Criteria:

* Inability to meet the above referenced inclusion criteria.
Bi-Ventricular Pacing in Patients With Atrial Fibrillation and Heart Failure (BIFF-Study)

Cardiac resynchronization therapy (CRT) is used to treat dilated heart failure with discoordinate contraction. Dyssynchrony typically stems from electrical delay leading to mechanical delay between the septal and lateral walls. Right ventricular apical pacing might be associated with long-term adverse effects on left ventricular function, and alternative pacing sites such as high septal or RVOT has been suggested. Previous studies have however been conflicting. The aim of this study is to determine if bi-ventricular pacing from RVOT + LV is better than RVapex+LV. To avoid influence from possible atrial delay only patients with chronic atrial fibrillation are included. All patients will receive a bi-ventricular pacemaker with 3 leads placed in RVapex, RVOT and via coronary sinus to pace the left ventricle. After a run in period (to determine if AV-junction ablation is necessary) the patients are randomised to one of the following pacing configurations: RVOT+LV or RVapex+LV with cross-over after 3 month.


Eligibility Criteria:
Inclusion Criteria:

* Heart failure NYHA III-IV
* LVEF\<35%
* QRS duration\>150 ms
* Chronic atrial fibrillation.

Exclusion Criteria:

* Heart failure not related to systolic function
* Unstable angina pectoris, AMI, PCI or CABG within 2 month
* Inclusion in other studies
HeadPulse Large Vessel Occlusion Validation Study

Acute ischemic stroke (AIS) is a treatable disease if patients can be transported and treated at stroke centers. MindRhythm, Inc (sponsor) has developed an investigational medical device that is designed for prehospital field use to differentiate the two major forms of acute ischemic stroke, namely Large Vessel Occlusion (LVO) stroke and non-large vessel occlusion stroke. The intended use is for paramedics to decide which destination hospital is best for the patient based on the device result. Large vessel occlusion stroke patients should be brought directly to comprehensive stroke centers which can perform thrombectomy, and non-large vessel occlusion stroke should be brought to primary stroke centers. Use of the device will save time getting the patient to thrombectomy and all others to intravenous thrombolytics or blood thinners that clear clots improves outcomes for all patients.

The Harmony 5000 device manufactured by MindRhythm has been tested in the pre-hospital environment, but because large vessel occlusion stroke is less common than non-large vessel occlusion stroke, the sponsor wants to obtain additional recordings from patients with large vessel occlusion to better refine their algorithms. Investigators will perform acute recordings on patients who arrive at the medical center who have computed tomography angiography studies showing the presence of large vessel occlusion stroke stroke, and on patients transferred to the angiography suite for thrombectomy. Recordings are performed in parallel to standard workflow of large vessel occlusion stroke patients so the research will not delay treatments.

Eligible participants will be 18 years of age plus with known large vessel occlusion who have been transferred to the emergency department. Recordings can be made just prior to the thrombectomy or within 2 hours of computed tomography angiography and no thrombectomy performed.

Participants will be excluded if they have an open wound on the scalp or are prisoners.

The MindRhythm Harmony headset will be placed on the subject (a total of 50 subjects) along with ECG leads and a 3 minute recording of the HeadPulse (cranial waveform) will be performed while the subject remains as still as possible. The data will then be transferred to MindRhythm for analysis and ultimate improvement of the diagnostic stroke algorithm.

Eligibility Criteria:
Inclusion Criteria:

* adult patient Known LVO (transferred or arrived at our ED) ICA-T, M1, M2 or Basilar Artery Recording can be made just prior to thrombectomy, or within 2 hours of CTA and no thrombectomy performed

Exclusion Criteria:

* Prisoner Open scalp wound
A Comparison of Aerius Continuous Treatment Versus Aerius PRN for Chronic Idiopathic Urticaria (Study P03147)

This double-blind pilot study was conducted to establish the best way of using desloratadine treatment to protect quality of life of chronic idiopathic urticaria (CIU) patients, after an initial 4-weeks of daily treatment: prolonging systematic daily treatment or as needed (PRN; in the case of symptoms).


Eligibility Criteria:
Inclusion Criteria:

* Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
* Subjects must be \>= 18 years of age
* Women of childbearing potential must have a negative urine pregnancy test at Visit 1 (Day 1) and must be using an acceptable method of birth control during the study.
* Subjects must be in general good health; ie, they must be free of any clinically significant disease (other than CIU) that would interfere with study evaluations.
* Subjects must understand and be able to adhere to visit schedules, and agree to complete the questionnaires and a diary.
* Subjects must have at least a 6-week history of CIU (pruritus and hives) prior to Visit 1.

Exclusion Criteria:

* Women who are pregnant or nursing.
* Subjects who used any investigational drug in the last 30 days prior to Visit 1
* Subjects with asthma requiring chronic use of inhaled or systemic corticosteroids.
* Subjects who have been treated with any investigational antibodies for asthma or allergic rhinitis in the 90 days prior to Baseline.
* Subjects who have been treated with intra-muscular or intra-articular corticosteroids in the 90 days prior to Baseline.
* Subjects with urticaria that is primarily due to physical urticaria or other known etiology, except dermographism.
* Subjects treated by immunosuppressive drugs.
* Subjects who have been hospitalized (including an emergency department visit) because of deterioration in their CIU within 3 months prior to Visit 1.
* Subjects with a history of hypersensitivity to desloratadine or any of its excipients.
* Subjects previously randomized into this study.
* Subjects who have any clinically significant metabolic, cardiovascular, immunological, neurological, hematological, gastrointestinal, cerebrovascular, or respiratory disease, or any other disorder which, in the judgment of the investigator, may interfere with the study evaluations or affect subject safety.
* Subjects with a history of psychosis, antagonistic personality, poor motivation, hypochondriasis, or any other emotional or intellectual problems that are likely to limit the validity of consent to participate in the study.
* Subjects with a history of noncompliance with medications or treatment protocols.