cyrilzakka/clinical-trials huggingface dataset:
Peer Partners to Improve Physical Activity in Older Latino and Latina Adults With Parkinson's Disease.

The goal of this interventional study is to culturally adapt and determine feasibility of the peer partner training program and the peer-supported mobile health physical activity intervention in older Latin/Hispanic people with Parkinson's disease.

The main question\[s\] it aims to answer are:

* What is the feasibility of the peer partner training program?
* What is the feasibility of the peer-supported mobile health physical activity intervention?
* What are the effects of the peer-supported mobile health physical activity intervention on physical activity, motivation, depression, apathy and self-efficacy?

Participants will be asked to:

* Wear a research-grade activity monitor, Actigraph GT9X device for 10 days at the beginning and end of the study.
* Watch 11 educational videos about Parkinson´s disease and exercise and attend two virtual educational sessions.
* Connect with another person with Parkinson´s disease one time a week on a virtual meeting platform for 8 weeks.
* Use Fitbit activity monitors and connect with other participants through the Fitbit application for 8 weeks.
* Attend a weekly online exercise class for 8 weeks with other people with Parkinon´s disease.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinson disease,
* Able to walk without the assistance of another person for 10 minutes

  -≥ 29 on Telephone Interview for Cognitive Status (TICS)
* To have a close friend/family member over the age of 18 that would support the participant during the intervention

  -≥ 50 years of age
* Hispanic
* To be willing to use an activity monitor and use a Fitbit and Fitbit application
* To be on a stable course of PD medications without any plans for change over the next 3 months
* To be able to speak, read and write in Spanish or English

Exclusion Criteria:

* Unstable cardiopulmonary, orthopedic, psychological or metabolic condition
* Atypical Parkinsonism Disorders
* A fall in the last 6 months (that was unrelated to an external force)
* Currently engaging in 150 minutes of mod-vigorous physical activity/week
A Study to Assess Long-term Safety, Tolerability and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy

The purpose of the study is to assess long-term safety and tolerability of weekly doses of rozanolixizumab in subjects with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).


Eligibility Criteria:
Inclusion Criteria:

* Subject who has completed one of the previous rozanolixizumab study(ies) that allow access to the present study (e.g. study CIDP01)
* Female subjects of childbearing potential must agree to use a highly effective method of birth control, during the study and for a period of 3 months after their final dose of investigational medicinal product (IMP)
* Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active during the study and for 3 months after the final administration of IMP

Exclusion Criteria:

* Subject has any medical (acute or chronic illness) or psychiatric condition that, in the opinion of the investigator, could harm the subject or would compromise the subject's ability to participate in this study
* Subject has a clinically relevant active infection (eg, sepsis, pneumonia, abscess)
* Subject has a known hypersensitivity to any components of rozanolixizumab
* Subject intends to have a live vaccination during the course of the study or within 7 weeks following the final dose of rozanolixizumab
* Subject has an ongoing serious adverse event (SAE) or a medical condition in the parent study that the investigator considers to put the subject at a significantly increased risk of participating in CIDP04
* Subject has any planned elective surgery due to occur during the study dosing period which in the opinion of the investigator could interfere with study procedures
A Study in Patients With Asthma

The purpose of the present study is to demonstrate the higher efficacy of Foster® NEXThaler® 100/6 extra fine (two inhalations b.i.d.) versus Seretide® Accuhaler® 250/50 (one inhalation b.i.d.), in terms of pulmonary function (change from baseline to the end of treatment in post-dose peripheral airway resistance) in patients with asthma.

Asthma is a chronic inflammatory disease characterised by variable airflow obstruction and bronchial hyper responsiveness. Asthma affects both the large and the small airways and there is a growing body of evidence that small airways impairment is an important contributor to the pathogenesis and clinical expression of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients aged ≥ 18, who have signed an Informed Consent form prior to initiation of any study-related procedure.
* Clinical diagnosis of asthma for a minimum of 12 months prior to screening confirmed by a chest physician according to international guidelines (GINA). The evidence of asthma must be confirmed through a documented (in the last three years) positive response to the reversibility test, defined as ΔFEV1 ≥ 12% and ≥ 200 mL over baseline, within 30 minutes after administration of 400 μg of salbutamol pMDI or through a documented (in the last three years) positive response to methacholine challenge test (PC20 \< 8 mg/mL or PD20 \< 1 mg).
* Baseline FEV1 \> 80% of the predicted normal value after appropriate washout from bronchodilators (to be checked at screening and at randomisation visits).
* Asthma Control Test score ≥ 20 and \< 25 (to be checked at screening and at randomisation visits).
* Impaired small airways function defined as baseline peripheral airway resistance \[R(5Hz)-R(20Hz)\] ≥ 0.07 kPa/L/s (to be checked at screening and at randomisation visits).
* Patients on previous regular treatment with Seretide® Accuhaler® (fluticasone propionate 250 μg plus salmeterol xinafoate 50 μg per actuation, daily dose of fluticasone 500 μg plus salmeterol 100 μg) at a stable dose for at least 2 months prior to inclusion.
* A cooperative attitude and ability to be trained to the proper use of DPI.

Main Exclusion Criteria:

* Patients with a diagnosis of COPD according to GOLD guidelines.
* Current smokers with a smoking history of \> 10 pack/year.
* Patients who have a clinical or functional uncontrolled respiratory, haematological, immunologic, renal, neurologic, hepatic, endocrinal or other disease, or any condition that might, in the judgment of the investigator, represent for the patients an undue risk or that could compromise the results or interpretation of the study.
* History or current evidence of uncontrolled heart failure, clinically relevant coronary artery disease, recent myocardial infarction, severe hypertension, uncontrolled cardiac arrhythmias.
* Patients treated with LABA or ICS/LABA fixed combination in the 24 hours before the screening visit.
* Severe asthma exacerbation leading to intake of systemic corticosteroids (\> 10 days) in the month before the screening visit.
Comparative Clinical Evaluation Between a Novel Self Adhesive and Conventional Bulk-fill Composites

This study aimed to evaluate the clinical performance of a novel, tooth-colored, self-adhesive bulk-fill restorative, and a conventional bulk-fill composite, for restoring class II cavities.


Eligibility Criteria:
Inclusion Criteria:

* Patients in need of restorative treatment on at least two class II Cavities in premolars or molars.
* Presence of proximal caries in digital x-ray with code 2 to 4 according to the radiographic International Caries Detection and Assessment System (ICDAS I).
* Presence of proximal caries in initial or moderate stage according to the International Caries Classification and Management System (ICCMS™).
* Only posterior teeth with class II cavities that have antagonistic contact and at least one proximal contact.
* Absence of parafunctional habits.
* Good general health

Exclusion Criteria:

* Serious medical disorders
* Clinical signs of bruxism, traumatic malocclusion
* Pregnant or breast feeding at the time of restoration placement
* Intolerance or allergy toward the applied restorative materials
Neotech RAM Cannula Versus Conventional Binasal Prong Continuous Positive Airway Pressure (CPAP) to Treat Respiratory Distress in Low Birth Weight Neonates

The purpose of this study is to determine if the RAM cannula is as effective as conventional binasal prongs to deliver CPAP to low birth weight infants with respiratory distress.


Eligibility Criteria:
Inclusion Criteria:

* Low Birth Weight Infant
* Currently on continuous positive aireway pressure of 5-7 cm water pressure
* Receiving continuous positive airway pressure support for \> 24 hrs prior to enrollment
* Fraction of inspired oxygen requirement of 23-50%

Exclusion Criteria:

* Fraction of inspired oxygen \> 50%
* Congenital defects of head, pulmonary or cardiovascular systems
* Chromosomal abnormalities/genetic syndromes
* Invasive Surgical Procedure within 24 hrs prior to enrollment
* Enrollment in separate clinical trial that has ongoing data collection
Primary Wound Closure Using a Limberg Flap Versus Secondary Wound Healing Following Pilonidal Sinus Excision

To compare primary wound closure using a limberg flap with secondary (p.s.) wound healing following excision of a pilonidal sinus.

Patients who gave their informed consent who had excision of pilonidal sinus were randomly assigned to group A (primary wound closure with a Limberg flap) or to group B (open wound and p.s.wound healing).

Eligibility Criteria:
Inclusion Criteria:

* indication for excision of pilonidal sinus given

Exclusion Criteria:

* limberg flap not possible for surgical reasons
Safety of Sticker Pad Containing Essential Oil Containing Lavender and Ylang-ylang Oil

The aims of the study were to evaluate safety of sticker pads containing lavender and ylang ylang oil in healthy volunteers.

The lavender and ylang ylang oil pad was attached to the shirts of healthy volunteers for 2 hours. The outcomes were evaluated before, during and 30 minutes after removal of the pad. Adverse reactions, irritation score, and quality of life were assessed. Blood pressure and pulse rate were also measured

Eligibility Criteria:
Inclusion Criteria:

* age 18 to 60 years
* no allergic history of lavender and ylang ylang oil
* no dermatological diseases, immunocompromised diseases, seizures, asthma, or respiratory diseases.

Exclusion Criteria:

* an unstable condition of other diseases
* olfactory problems
* pregnancy
* lactation
Dose-related Effects of Vitamin D3 on Immune Responses in Patients With Clinically Isolated Syndrome

The primary purpose of this study is to assess the immune response to vitamin D supplementation at two doses (5,000 IU and 10,000 IU daily) in both healthy controls and patients with clinically isolated syndrome compared to placebo. Secondary endpoints include (1) disease outcome in the clinically isolated syndrome in terms of clinical relapses and evidence of new lesions on MRI (McDonald's MS), 2) Safety of doses used

Primary endpoint: To determine the effects of vitamin D supplementation at two doses a) 5,000 IU daily b) 10,000 IU daily compared to c) placebo a 24 weeks period on the change from baseline in frequency of CD4 T cell subsets and cytokine responses by peripheral blood mononuclear cells in 1) patients with the clinically isolated syndrome. 2) healthy control participants.

Secondary endpoints:

1. To determine whether there is a dose response effect of supplementation using 5,000 IU and 10,000 IU of vitamin D versus placebo over 24 weeks on the change from baseline in the frequency of CD4 T cell subsets and cytokine responses by PBMC in 1) patients with the clinically isolated syndrome (CIS) 2) healthy control participants
2. To establish whether there is a clinical response to vitamin D measured by a) change in the number of T2 lesions and Gadolinium enhancing lesions on MRI scanning at 24 weeks compared to baseline b) reduction in relapses over 24 weeks in treated (both 5,000 IU and 10,000 IU) CIS patients versus CIS patients receiving placebo.

Eligibility Criteria:
Inclusion Criteria: To be eligible for inclusion, each subject must meet each of the following criteria at Screening (Visit 1) and must continue to fulfil these criteria at Baseline (Visit 2).

* CIS: Patients with a clinically isolated syndrome with onset relapse within the previous three months and two or more than two asymptomatic T2 lesions on MRI brain scan.
* Aged 18-55yrs.
* Not receiving any disease modifying therapy.

Exclusion Criteria:

* Patients in whom any disease other than demyelination could explain their signs and symptoms.
* Participants with known disease of the parathyroids, a history of vitamin D intolerance, sarcoidosis, a history of hypercalcaemia of any cause.
* Participants with a baseline abnormality in serum urea, creatinine, calcium, parathormone.
* Participants on thiazide diuretics (hypercalcaemia risk).
* Patients with occurrence of a relapse less than six weeks prior to entry to study.
* Previous treatment with beta-interferons or glatiramer acetate or steroids in the last three months.
* Any previous treatment with mitoxantrone or other immunosuppressant.
* Participants already taking supplemental vitamin D.
Physical Activity Intervention for Patients Following Lumbar Spine Surgery

There is a critical need to target physical activity during postoperative management to optimize long-term recovery after lumbar spine surgery. The overall objective of this study is to conduct a two-group randomized control trial (RCT) to examine the feasibility and acceptability of a physical activity telehealth intervention delivered by a physical therapist for improving disability, physical function, pain, and physical activity compared to usual care after spine surgery for a degenerative lumbar condition. The physical activity intervention will include wearable technology and remote physical therapist support to counsel patients on a realistic progression of physical activity (steps per day). The central hypothesis is that this 8-week physical activity intervention performed at two weeks after surgery will be feasible and acceptable. The results of our randomized trial will be used to support a large multi-site clinical trial to test the effectiveness and implementation of this intervention


Eligibility Criteria:
Inclusion Criteria:

1. Adults age 18 years or older, of both sexes and all races
2. Scheduled for surgical treatment of a lumbar degenerative condition (spinal stenosis, spondylosis with or without myelopathy, and degenerative spondylolisthesis) using laminectomy with or without arthrodesis (i.e., fusion) procedures.
3. Participants will be English speaking due to the feasibility of employing study personnel to deliver and assess the study intervention.

Exclusion Criteria:

1. Patients having microsurgical techniques as the primary procedure, such as an isolated laminotomy or microdiscectomy will be excluded because individuals having these minimally invasive surgical techniques tend to have a less severe case of lumbar degeneration.
2. Patients having surgery for spinal deformity as the primary indication or surgery secondary to pseudarthrosis, trauma, infection, or tumor
3. Prior history of lumbar spine surgery
4. Presence of back and/or lower extremity pain \< 3 month
5. History of neurological disorder, resulting in moderate to severe movement dysfunction
6. Unable to provide stable address and access to a telephone indicating the inability to participate in the intervention.
Study of AMG531(Romiplostim) in Patients With Aplastic Anemia

To evaluate the hematological responses based on the response assessment criteria when AMG531 is subcutaneous (SC)-administered with anti-human thymocyte immunoglobulin (ATG) + ciclosporin A (CsA) therapy for 6 months in patients with aplastic anemia (AA) who were previously untreated with immunosuppressive therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntary signed informed consent to participate in the study;
2. A diagnosis of AA confirmed by blood and bone-marrow examinations, etc.;
3. Considered to require new treatment with ATG and CsA provided that NSAA must be platelet or erythrocyte transfusion-dependent.
4. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 1at screening

Exclusion Criteria:

1. Previously treated with ATG, CsA, or Alemtuzumab;
2. Diagnosed as having congenital AA (Fanconi anemia, congenital dyskeratosis, etc.);
3. Diagnosed as having AML or chronic myelomonocytic leukemia;
4. Concurrent thrombocytopenia of other etiologies (e.g., MDS, ITP, cirrhosis);
5. Concurrent active infection not adequately responding to appropriate therapy;
6. Concurrent clinically significant illness(es) items which are deemed by the Investigator to be likely to affect the study conduct and assessments.
7. Having active malignancies, or having a history of treatment of malignancies within 5 years prior to informed consent.
8. Concurrent PNH
9. Having Grade 2 or higher bone marrow reticulin based on Bone Marrow Pathology (2nd edition) ;
10. History of chromosome aberrations discovered in bone marrow cells.
11. Having blast cells \> 2% in bone marrow;
12. Positive for anti-human immunodeficiency virus (HIV) antibody;
13. Receiving prophylactic or therapeutic treatment for hepatitis type B
14. Positive for hepatitis C virus (HCV) antibody, and HCV infection being confirmed
15. Planned hematopoietic stem cell transplantation during the study;
16. Systemic treatment with any of the following medication for the treatment of AA within 4 weeks before Day 1, however, excluding their use as premedication:

    * Anabolic steroids
    * Corticosteroids;
17. Pregnant or breastfeeding women, or women willing to become pregnant;
18. Other conditions unsuitable for participation in the study in the opinion of the Investigator.
Group Toilet Training of Healthy Children, in Daycare Centers (CRCT)

Evaluation of a new method of toilet training (TT), meaning TT in group in daycare centers, guided by a TT expert. Children are included based on signs of readiness for TT.

A cluster randomized controlled trial (CRCT) was established in daycare centers. Clusters of participants (per daycare center) were randomly allocated to an Intervention group or a Control group.

Evolution of the TT process was monitored in the daycare center until the child was considered to be fully toilet trained (or 'clean') during the day (this means wearing undergarments, conscious of the need to void and initiating toilet behavior without reminder of the parents with a maximum of one leakage a day \[9\]).

Daycare workers evaluated the TT process of all participating children on a weekly basis. Parents were asked to fill in an online questionnaire when their child was completely toilet trained.

Eligibility Criteria:
Inclusion Criteria:

* knowledge of the Dutch language
* aged between 18 and 30 months
* not yet toilet trained during the day and night (diaper dependent)
* Parents of the children had to be motivated to participate in the study and willing to invest time and effort in continuing the TT at home
* Children met at least two of the following three signs of readiness: the child expresses a need to evacuate and shows awareness of the need to void or to have a bowel movement; the child insists on completing tasks without help and is proud of new skills; or the child can pull clothes up and down in a TT related context

Exclusion Criteria:

* Children with urological, neurological, organical or behavior problems
Regorafenib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Patients With Advanced Colorectal Cancer

This is a multicenter observational study aimed to describe the efficacy and safety of regorafenib plus programmed cell death-1 (PD-1) inhibitors in Chinese patients with advanced colorectal cancer in routine clinical practice. The primary end point is overall survival. The secondary endpoints include progression-free survival, objective response rate, disease control rate and the incidence of treatment-related adverse events.

The investigators retrospectively identify patients with advanced colorectal adenocarcinoma who received at least one dose of PD-1 inhibitors plus regorafenib from 5/2019 to 2/2021 in 14 Chinese medical centers. Patients received the study treatment as part of routine medical care based on the consensus of clinicians and patients. In addition to the primary and secondary outcomes, other patient and treatment characteristics including baseline microsatellite instability status, metastatic sites, previous treatment regimens, post-treatment regimens, are collected in order to describe the real-world treatment patterns.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age and older
2. Histologically or cytologically confirmed advanced or metastatic colorectal adenocarcinoma
3. Disease progression on standard of care therapy
4. Patients must have received at least one dose of PD-1 inhibitors in combination with regorafenib
5. At least one available laboratory or vital sign measurement obtained subsequent to at least one dose of study treatment for safety analysis
6. Confirmed treatment discontinuation/disease progression/available radiological evaluation or at least eight weeks of follow-up subsequent to the first dose of study treatment for efficacy analysis
7. Prior exposure to regorafenib monotherapy or a PD-1 inhibitor monotherapy was allowed

Exclusion Criteria:

1. Other malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinoma of the skin
2. Participation in other interventional studies while receiving regorafenib plus a PD-1 inhibitor
Safety Study of XL147 (SAR245408), in Combination With Paclitaxel and Carboplatin in Adults With Solid Tumors

The purpose of this study is to evaluate the safety and tolerability of XL147 in combination with paclitaxel and carboplatin in adults with solid tumors. XL147 is a new chemical entity that inhibits PI3 Kinase. Inactivation of PI3K has been shown to inhibit growth and induce apoptosis (programmed cell death) in tumor cells. In clinical practice, the combination of paclitaxel and carboplatin is an accepted treatment regimen for various solid tumors, including ovarian cancer, endometrial cancer and non-small cell lung cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of:

  * Advanced solid tumor that is no longer responding to therapies OR
  * Advanced or recurrent endometrial carcinoma OR
  * Advanced or recurrent ovarian carcinoma OR
  * Unresectable (Stage IIIB or IV) NSCLC
* ECOG Performance Status 0-1 (ECOG status of 2 may be considered following discussion and agreement with sponsor)
* Adequate organ and bone marrow function as defined by hematological and serum chemistry limits
* At least 18 years old
* Both men and women must practice adequate contraception
* Informed consent

Exclusion Criteria:

* Restriction of some therapies/medications within specific timeframes prior to enrollment and during the study including prior therapy with PI3K, AKT, or mTOR inhibitors, cytotoxic chemotherapy, biologic agents, nitrosoureas or mitomycin C, small-molecule kinase inhibitors, non-cytotoxic hormonal agents
* Known allergy or hypersensitivity to any of the components of the treatment formulations
* Taking oral corticosteroids chronically or \> 1 mg/day warfarin
* Not recovered from the toxic effects of prior therapy
* History of diabetes mellitus.
* Uncontrolled intercurrent illness
* Pregnant or breastfeeding
* Congestive heart failure, unstable angina, or a myocardial infarction within 3 months of entering the study.
* HIV positive
* Diagnosis of another malignancy may exclude subject from study