cyrilzakka/clinical-trials huggingface dataset:
An Observational Study Using Multimodal Sensors to Measure Cognitive Health in Adults and Distinguish Mild Cognitive Impairment From Normal Aging

The primary objectives are to develop and validate a classifier using multimodal passive sensor data and metrics derived from normal iPhone and Apple Watch usage to distinguish individuals with normal cognition from those with mild cognitive impairment (MCI) and to develop and validate a cognitive wellness score that tracks fluctuations in cognitive performance over time using multimodal passive sensor data and metrics derived from normal iPhone and Apple Watch usage.


Eligibility Criteria:
Key Inclusion Criteria:

* Fluent in spoken and written English
* Minimum 8 years of education or 8th grade equivalent.
* Willing to authorize the use of confidential health information in accordance with applicable privacy regulations.
* Willing to wear an Apple Watch for daily use for the duration of the study.
* Willing to use their personal iPhone for routine daily use for the duration of the study.
* Technical requirements:

iPhone models: iPhone 8 or newer iOS versions: current publicly available iOS version

* Access to one of the following personal computing devices. Microsoft Windows based personal computers (laptops and desktops) Mac personal computers (laptops and desktops) Apple iPad tablets
* Access to WiFi or hardwired internet access in participant's place of residence.
* Active email address for enrollment account creation and for use in relaying study information.
* Active mobile telephone number for use in relaying study information when appropriate.
* Primary address within the United States (50 states and Washington, DC; not a post office (PO) box).

Key Exclusion Criteria:

* Inability to comply with study requirements.
* Any self-reported medical history of dementia (such as Alzheimer's disease, frontotemporal dementia, dementia with Lewy body, vascular dementia, rapidly progressive dementia, or Parkinson's disease dementia).
* Self-reported dependence on others to perform core activities of daily living, including feeding, dressing, bathing, toileting, or grooming.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
An Observational Study of the Impact of RoActemra/Actemra on Fatigue in Patients With Rheumatoid Arthritis (PEPS)

This prospective, observational study will assess the effect of RoActemra/Actemra (tocilizumab) on fatigue in patients with moderate to severe rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs (DMARDS) or anti tumor necrosis factor (anti-TNF) drugs. Eligible patients receiving RoActemra/Actemra according to the standard of care will be followed for 4 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Moderate to severe rheumatoid arthritis
* Inadequate response to disease-modifying antirheumatic drugs (DMARDS) or anti-TNF (tumor necrosis factor) drugs

Exclusion Criteria:

* Hypersensitivity to RoActemra/Actemra or any component
* Active infection
* Participation in a clinical trial in rheumatoid arthritis
Measurement of Eye Movements While Reading a German Text

To establish normative value for reading parameters in healthy children of primary school age and in grades 2-5.

Following initial assessment of feasibility, recruitment is expanded to children attending grades 2-5 recruited from 4 different primary schools in German speaking Switzerland. Two texts of The New International Reading Speed Test (IReST) of similar difficulty are presented on a laptop in randomized order. Children are asked to read the text aloud while eye movements are recorded with an eye tracking bar. The following parameters are analysed: reading speed (words/minute), number of saccades, number of fixations.

Eligibility Criteria:
Inclusion Criteria:

* 8-13 years
* child consent
* parental consent

Exclusion Criteria:

* unability to read
Echo: Optimizing a Group-based School Intervention for Children With Emotional Problems

The present study (Echo) will promote much needed research and innovation that optimize service provision in first line health services for the alarmingly high number of school children who suffer from clinical and subthreshold levels of anxiety and depression. The effect of different versions of an evidence-based intervention for this group of children will be tested using a cluster randomized design involving 40 schools across Norway. The aim is to create a framework that allows more evidence-based psychosocial interventions to be provided at a lower cost to society. Echo will provide knowledge about three main evidence gaps for children: (1) The effect of school-based preventive interventions on anxiety and depression; (2) The effect of feedback informed systems, and; (3) the effect and cost-effectiveness of digital health interventions using online sessions and virtual reality technology.


Eligibility Criteria:
Inclusion Criteria:

• Children scoring one standard deviation or more above population mean using established measures for anxiety and/or depression

Exclusion Criteria:

* Retardation or language problems
* Developmental conditions
* Individual considerations approved by the local PI
Discovery of the Impact of Targeted Lung Denervation (TLD) on the Severe and Very Severe COPD Population

The DISCOVER TLD study is a multicenter, prospective, single-arm study designed to record the clinical outcomes of the CE-marked Nuvaira™ Lung Denervation System, in a subset of its CE-marked approved indication. This study is being conducted in Europe.

The purpose of this study is to evaluate the overall COPD patient experience with the Nuvaira™ Lung Denervation System and allow for the continued collection of safety and effectiveness data on the CE-marked product. The study is a multicenter, prospective, single-arm study designed to include patients, on average, who fall within a more severe stage of COPD, defined as 20-45% FEV1 percent predicted. Subjects will remain on respiratory medications per their standard of care and will be followed and tested per standard of care throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD with 20% ≤ FEV1 ≤ 45% and FEV1/FVC \< 70% (post-bronchodilator)
* History of long-term smoking, but non-smoking for a minimum of 2 months prior to study consent
* Patient is a candidate for bronchoscopy
* Patient agrees to all follow-up and provides written informed consent.

Exclusion Criteria:

* Presence of lung or chest implants (eg. metal stent, valves, coils)
* Pregnancy
* Pre-existing pulmonary hypertension
* Patient has a pacemaker, internal defibrillator, or other implantable electronic device
* Inappropriate bronchial anatomy for procedure (per CT scan)
* Previous abdominal surgical procedures on stomach, esophagus or pancreas
* Previous treatment with TLD Therapy (in same areas)
* Known allergy to bronchoscopy or general anesthesia medications
* Inability to tolerate single lung ventilation for at least 2 min, 30 sec
* Patient has a GCSI score of ≥ 18 at time of screening visit
Prospective, Randomized, Multicenter, Control Study to Assess the Efficacy and Safety of Tacrolimus in Induction and Maintenance Phase Treatment in Lupus Nephritis

The purpose of this study is to compare the efficacy and safety of tacrolimus vs intravenous cyclophosphamide pulses treatment for the induction therapy of LN(III,IV,V).

To compare the efficacy and safety of tacrolimus vs Azathioprine for the maintenance therapy of LN(III,IV,V).


Eligibility Criteria:
Inclusion Criteria:

1. Subjects of either sex, 14-65 years of age;
2. Diagnosis of SLE according to the ACR criteria(1997);
3. Kidney biopsy within the 6 months prior to first randomization with a histologic diagnosis (ISN/RPS 2003 classification of LN) class III, IV, V;
4. Class IV LN: proteinuria \>1g/24hr or Scr\>115umol/L;
5. Class III or V LN: proteinuria \>2g/24hr or Scr\>115umol/L;
6. Provision of written informed consent by subject or guardian.

Exclusion Criteria:

1. Inability or unwillingness to provide written informed consent ;
2. Known hypersensitivity or contraindication to tacrolimus, cyclophosphamide , azathioprine, corticosteroids;
3. Usage of immunosuppression therapy (MMF, CTX, CysA, MTX ect) for more than 1 week within 1 month prior to first randomization;
4. Pregnancy, nursing or use of a non-reliable method of contraception;
5. Continuous dialysis starting more than 2 weeks before randomization into the induction phase and/or continuous dialysis with an anticipated duration of more than 8 weeks;
6. Previous kidney transplant or planted transplant;
7. Scr \> 4mg/dl (353umol/L);
8. Active hepatitis, with liver dysfunction;
9. Diagnosed DM;
10. Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening .
A Phase 1 Single Dose Study of E6011 in Japanese Healthy Adult Male Subjects (Study E6011-J081-001)

To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single ascending dose (SAD) administration of E6011 in Japanese healthy volunteers.


Eligibility Criteria:
Inclusion criteria;

1. Non-smoking Japanese male subjects aged \>= 20 to less than 45 years
2. BMI at screening is \>= 18.5 kg/m2 to less than 25.0 kg/m\^2
3. Males who have not had a successful vasectomy and their female partners must agree to practice highly effective contraception throughout the study period.

Exclusion criteria;

1. Has been treated with biologic products (except for immunoglobulin preparation)
2. Have received immunoglobulin or blood preparation within 6 months before the study drug administration
3. Received inoculation within 4 weeks before the study drug administration
4. Has a history of autoimmune disease or immunodeficiency
5. Has a clinically significant angioedema, hematemesis, anal hemorrhage, or hemoptysis
6. Has a history of acute myocardial infarction, cerebral infarction, cerebral hemorrhage, or arteriosclerosis obliterate
7. With gross hematuria, occult bleeding in urine (\>=1+) and urine protein (\>=1+) , or either of (\>=2+) at screening
8. Has a clinically significant vasculitis (e.g., multiple mononeuropathy)
9. Known to be positive for human immunodeficiency virus (HIV antigen and antibody), hepatitis B virus surface antigen (HBs antigen), hepatitis B virus surface antibody (HBs antibody), hepatitis B virus (HBV) DNA, hepatitis C virus (HCV) antibody, or syphilis serology test
10. Known to be positive for human T-cell lymphotropic virus type 1 (HTVL-1) antibody at screening
11. Known to be positive for QuantiFERON-TB Gold Test
12. Treated with ethical drug(s) within 4 weeks before the study drug administration (except for disinfectants, eye drops)
13. Treated with non-prescription drug(s) within 2 weeks before the study drug administration (except for disinfectants, eye drops)
14. Has participated in another clinical trial and received an investigational drug or device within 6 months before the study drug administration
15. Received blood transfusion within 1 year, 400 mL or more whole blood donation within 12 weeks, or 200 mL or more whole blood donation within 4 weeks, or blood constituent donation within 2 weeks before the study drug administration.
Trial to Compare MRI-guided Precision Prone Irradiation (PPI) Versus CT-guided Breast Irradiation

The Investigators are investigating the potential role of MRI-guided Radiation Therapy for patients receiving breast radiotherapy in the prone position with a MRI-Linac radiotherapy system, the Precision Prone Irradiation (PPI) technique.

Hypothesis: The investigators would like to hypothesize that breast radiation therapy using MRI-guided system including the MRI-Linac (Arm 2) is comparable to the current standard of treatment using conventional CT-based system (Arm 1), in terms of local control of the disease at 2 year time point.

Breast conserving surgery and adjuvant whole breast radiotherapy is a standard treatment option for most patients with early-stage invasive breast cancer. Recent technological advances in radiotherapy have enabled shorter treatment courses, smaller radiation fields, prone positioning, and fewer side effects associated with breast cancer treatment. To further improve target accuracy in breast radiation delivery, an emerging radiotherapy technology takes advantage of on-table MRI imaging and daily adaptive planning during the radiation delivery process.

The objectives of the study are to compare side effects in patients treated under either of these treatment settings and to compare recurrence (if the cancer comes back) rates at a 2-year time point. Patients will have annual follow ups up to 10 years and recurrence rates will be measured at 5-year and at 10-year time points.

Eligibility Criteria:
Patients ≥ 50 yrs with histologically confirmed unilateral DCIS or Stage I invasive breast cancer; received breast conserving surgery (pN0 or pNx) with tumor pathology ≤ 2 cm and excision margin ≥ 1 mm

Inclusion Criteria:

* Women status post segmental mastectomy
* If unilateral, pT1 breast cancer excised with negative margins AND/OR pTis excised with negative margins.
* If bilateral, pT1 breast cancer excised with negative margins AND/OR pTis excised with negative margins.
* Clinically N0 or pN0 or sentinel node negative
* Ductal carcinoma in situ DCIS with negative margins (no DCIS on inked margins).

Exclusion Criteria:

* Previous radiation therapy to the ipsilateral breast.
* \> 90 days from last surgery, unless s/p adjuvant chemotherapy
* \> 60 days from last chemotherapy
* Patients unable to tolerate MRI or are otherwise unsuitable for MRI-based RT treatment
* Metastatic disease
Bandebereho 6 Year Follow up RCT in Rwanda

This study seeks to conduct a six-year follow-up of the Bandebereho randomized control trial (RCT) to assess the longer-term impact of the gender-transformative Bandebereho couples intervention on participating men, women, and their children. The Bandebereho program was implemented by the Rwanda Men's Resource Centre (RWAMREC) and Promundo-US, in collaboration with the Rwanda Ministry of Health and local authorities between 2013 and 2015. A two-arm RCT collected three rounds of data from 1,199 couples (575 treatment; 624 control) starting in 2015-16: baseline (pre-intervention), 9 month follow-up, and 21-month follow-up. The findings at 21-months demonstrated significant impacts of the intervention on multiple gender and health-related outcomes. This study will conduct surveys with men enrolled in the RCT and their female partners 6 years after the intervention, to assess its long-term impact on reproductive and maternal health, gender attitudes and household dynamics, intimate partner violence, mental health and wellbeing, parenting, and child development. In addition, child assessments will be conducted with a sub-sample of 800 children aged 4 to 7 years to directly assess early childhood development outcomes.

This study seeks to conduct a six-year follow-up of the Bandebereho randomized controlled trial (RCT) to assess the longer-term impact of the gender-transformative Bandebereho couples intervention on participating men, women, and their children. The Bandebereho program being assessed was first implemented by the Rwanda Men's Resource Center (RWAMREC) and Promundo-US, in collaboration with the Rwanda Ministry of Health and local authorities in Karongi, Musanze, Nyaruguru and Nyaruguru districts between 2013 and 2015. A two-arm RCT was conducted with 1,199 couples (575 treatment; 624 control) in 2015-16. Three rounds of data were collected: baseline (pre-intervention), 9 month follow-up (4 months post-intervention), and 21-month follow-up (16 months post-intervention). The findings at 21-months demonstrated significant impacts of the intervention on multiple gender and health-related outcomes. The proposed study will conduct surveys with men enrolled in the RCT and their female partners, to assess the longer-term impact of the intervention on reproductive and maternal health, gender attitudes and household dynamics, intimate partner violence, mental health and wellbeing, parenting, and child development. In addition, child assessments will be conducted with a sub-sample of 800 children aged 4 to 7 years to directly assess early childhood development outcomes.

Eligibility Criteria:
Inclusion Criteria at baseline:

* Men aged 21-35 years
* Living with a partner
* Expectant (or soon to be) father or father of young children under-5
* Living in an area with a group facilitator

Exclusion Criteria at baseline:

- Participated in previous cycles of the same intervention
Isometric Intervention for Lateral Elbow Tendinopathy

This study will be looking at people with lateral elbow tendinopathy (elbow pain). The goal is to determine if a one-time isometric intervention will positively change the level of pain and strength as compared to baseline measurements. After determining baseline strength and pain level, an intervention consisting of several trials of isometric hand/wrist contractions will be performed by the participant. Pain and strength will again be assessed immediately after the intervention.

Participants will be randomized into two different groups in 10 participant blocks, meaning after every 10 participants eligible and completing the study, there will be 5 participants assigned to each group. Group 1 will complete a protocol with 10 sets of 10 second isometric holds followed by 10 second rest intervals between sets. Each repetition will be performed as closely to the targeted 30%-40% value. Group 2 will complete a protocol with 5 sets of 20 second isometric holds followed by 20 second rest intervals between sets. Each repetition will be performed as closely to the targeted 30% value. Resistance for both testing conditions will be performed against the examiner's external resistance/against the Microfet hand held dynamometer. Immediately after the intervention, all participants will again repeat their maximal grip on their affected arm using the Jamar hand held dynamometer and will grade their pain level. (The protocol will be identical to the pre testing procedure from above). The pain score and force output will be obtained and documented. Once these steps are complete, testing will cease. All participants will be instructed to follow their referring provider's treatment intervention.

Eligibility Criteria:
Inclusion Criteria:

* - 18 years old or older
* Currently has lateral elbow pain
* If bilateral lateral elbow pain is present, the more symptomatic side will be assessed
* At the time of presentation, individuals have been evaluated as having clinical diagnosed LET for at least 4 weeks
* AND: Positive pain response to at least two of the following tests:

  * Pain with palpation on the affected elbow
  * Pain with resisted wrist or middle finger extension
  * Pain while stretching the lateral forearm muscles (Mills Test)
  * At least 30% deficit of pain-free grip compared with the unaffected side

Exclusion Criteria:

* - Radicular/Cervical conditions reproducing elbow symptoms
* rheumatoid arthritis
* Other elbow pathologies: bursitis, medial epicondylalgia, radial nerve entrapment, posterolateral rotary instability
* History of fracture to the radius, ulna, or humerus with resultant deformity of the involved extremity
* History of an injection within 6 months
* Inability to place the shoulder, elbow and wrist in the required testing position
* The affected elbow had been operated on
QuickVue Influenza A + B Test Field Study

Demonstrate improved clinical performance of visually read QuickVue Influenza A+B test.

The objective of this study is to demonstrate an improved clinical performance of the visually read QuickVue Influenza A+B test with nasal and nasopharyngeal swab specimens. Clinical performance will be based on comparison of QuickVue results to either cell culture or an FDA-cleared molecular test at one or more Reference Laboratories.

Eligibility Criteria:
Inclusion Criteria:

Subjects will be recruited from the general population as they present to the clinical facility. Subjects must have had a fever within the last two days and exhibiting one or more symptoms characteristic of influenza. They must meet the following criteria to be eligible for enrollment:

1. Male or Female of all ages (with appropriate consent).
2. The subject must have had of a fever, ≥ 37.8º C (100º F), within the last two days.
3. Must also be currently exhibiting one or more of the following symptoms characteristic of influenza-like-illness (ILI).

   1. Nasal congestion
   2. Rhinorrhea
   3. Sore throat
   4. Cough
   5. Headache
   6. Myalgia
   7. Malaise

Exclusion Criteria:

* 1. Has undergone treatment with anti-influenza antivirals within the previous 7 days, to include but not be limited to, Amantadine, Rimantadine, Ribavirin, Oseltamivir, Zanamivir or any other antiviral currently available in these classes.

  2. Has been vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7 days.

  3. Unable to understand and consent to participation; for minors this includes parent or legal guardian.
Enhanced Perioperative Mobilization (EPM) Trial

Randomized Controlled Trial to monitor and increase the postoperative mobilization of the patients undergoing major visceral surgery by giving a continuous autofeedback of the step count using activity tracking wristbands.

Patients undergoing elective open and laparoscopic surgery of colon, rectum, stomach, pancreas and liver for any indication will be included. Further inclusion criteria are: age between 18-75 years, ASA score \< 4, and a signed informed consent. Patients are stratified into two subgroups (laparoscopic and open surgery) and will be randomized 1:1 for an autofeedback of their step-count using an activity tracker wristband or for the control group without autofeedback. Sample size (n = 29 patients in each of the four groups, overall n = 119) is calculated on an assumed difference in step-count of 250 steps daily (intervention versus control group). The primary study endpoint is the step-count during the first five postoperative days; secondary endpoints are the percentage of patients in the two groups, who master the predefined mobilization (step-count) targets, the assessment of additional activity data from the devices, the assessment of the preoperative mobility, length of hospital and intensive care unit stay, number of patients who receive physiotherapy, 30-day mortality, and the overall 30-day morbidity.

Eligibility Criteria:
Inclusion Criteria:

* elective laparoscopic and open surgery of the colon and rectum (colectomy, hemicolectomy, segment resection, rectum extirpation, deep anterior rectum resection, sigmoid resection, proctocolectomy), of the stomach (total, subtotal and atypical gastric resections), of the pancreas (any kind of pancreatic resections), and of the liver (hemihepatectomy, atypical resection, anatomical segment resection)
* ASA score \< IV
* completed informed consent.

Exclusion Criteria:

* emergency surgery
* mental inability to complete postoperative assessment protocols
* preoperatively immobile patients