cyrilzakka/clinical-trials huggingface dataset:
PQR309 and Eribulin in Metastatic HER2 Negative and Triple-negative Breast Cancer (PIQHASSO)

This study is an open-label,non randomized, multi-center, phase 1/2b (dose escalation followed by expansion part) study evaluating clinical safety, efficacy and pharmacokinetics of PQR309 in combination with standard dose of eribulin in patients with locally advanced or metastatic HER2-negative (escalation part) and Triple Negative Breast Cancer (expansion part).

* The primary objective of the escalation part is to assess the maximum tolerated dose (MTD) of PQR309 combined with the standard eribulin dose in patients with HER2 negative breast cancer following a "modified" 3 by 3 design.
* For the expansion part the objective is to evaluate efficacy of PQR309 in combination with eribulin in patients with Triple Negative Breast Cancer
* Once the MTD of continuous daily PQR309 dosing has been established, intermittent schedules of PQR309 ("2 days on/ 5 days off" or "Monday / Thursday") will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Histologically/cytologically confirmed diagnosis of breast cancer. Radiological evidence of inoperable locally advanced or metastatic breast cancer.
* HER2 negative breast cancer (based on the most recent analyzed biopsy) defined as a negative in situ hybridization test or an immunohistochemistry status of 0, 1+ or 2+.
* Received at least 2 and no more than 5 prio chemotherapeutic regimens in locally advanced and/or metastatic setting.
* Prior therapy has to include an anthracycline and a taxane in any combination or order.
* For Expansion part:

Triple-negative breast cancer defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0,1+ or 2+ER abnd PR status \<10% by local laboratory testing.

Exclusion Criteria:

* Previous systemic treatment with PI3K,mTOR or AKT inhibitors (allowed in the escalation part).
* Previous treatment with eribulin (allowed in the escalation part). Known hypersensitivity to any of the excipients of PQR309 or eribulin.Concurrent treatment with other approved or investigational antineoplastic agent.
* Symptomatic Central Nervous System metastases. The patient must have completed any prior local treatment for CNS metastases \> 28 days prior to first dose of the study drug (including radiotherapy and/or surgery).
* Clinically manifested diabetes mellitus(treated and/or clinical signs with fasting glucose \>125mg/dl or HbA1c\>7%), or documented steroid induced diabetes mellitus.
Evaluation of Treatment Satisfaction in Children With an Allergy and Who Received an Antihistamine

This is a non-interventional retrospective data collection study from children aged from 2 to 12 years old diagnosed with an allergy and who received a treatment consisting of an H1-antihistamine. The period of last taken medication will be observed to evaluate the global satisfaction of the parents and physician for this last treatment.


Eligibility Criteria:
Inclusion Criteria:

* Children from 2-12 included
* History of allergy
* Used an Antihistamine within market authorization

Exclusion Criteria:

* Child not yet treated for the presented allergy
ABLE (Arts-Based Exercise Enhancing LongEvity)

Older adults who are referred to home care physiotherapy often only get to see the physiotherapist three to five times and are expected to continue exercising on their own. We have developed an interactive technology called ABLE that helps older adults do exercise in their homes by making it fun and interactive. We want to see if we can help 25 older adults to exercise with ABLE for three months and if exercising with ABLE for three months changes older adults' strength and balance. A physiotherapist will visit the older adults three times in their homes and show them how to use ABLE and which exercises to do. We will measure older adults' strength and balance before and after using the program and ask them and their family members for feedback about using ABLE. The results of our study will help us decide if we can do a bigger study to test the effect of using ABLE in a larger group of older adults, and to see what effect ABLE might have on strength and balance. The study will also help us incorporate feedback from the older adults and their families to improve ABLE for the next study.


Eligibility Criteria:
Inclusion Criteria:

* able to stand and walk independently with or without an assistive aid (e.g., walker, cane)
* may have a diagnosis of dementia or cognitive impairment (MoCA \< 25, MMSE \<24, Mini-Cog \<3) if they have caregiver willing to assist with exercises and consent

Exclusion Criteria:

* have a diagnosis of dementia or cognitive impairment (MoCA \< 25, MMSE \<24, Mini-Cog \<3) and have no family member to assist with exercises and consent
* documented absolute contraindications to exercise
Efficacy and Safety of Rectally Administered BBT-401-1S in Subjects With Ulcerative Colitis

This is an open label, single-arm, proof of mechanism study to explore the efficacy and safety of rectally administered BBT-401-1S in subjects with ulcerative colitis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, of any race, ≥18 and ≤60 years of age on Day 1.
* Have been diagnosed with active distal UC for ≥3 months prior to Day 1, as determined by clinical and endoscopic evidence and documented in a histopathology evaluation.
* Have UC that is restricted to between the descending colon and the rectum (ie, left sided distal colitis), with demarcation of the lesion confirmed by endoscopy.
* Have a total Mayo score ≥6, an endoscopic subscore ≥2, rectal bleeding subscore ≥1, and a stool frequency subscore ≥1.

Exclusion Criteria:

* Have used any biologics or Janus kinase (JAK) inhibitors including, but not limited to, anti TNF α biologics or tofacitinib for the treatment of UC.
* Have used any purine analogues (azathioprine, mercaptopurine, or thiopurines) or immunosuppressants (methotrexate or cyclosporine) for the treatment of UC within 12 weeks or have any history of nonresponse to these medications.
* Have used any rectal therapy for the treatment of UC with exception of rectal suppository of 5-aminosalicylic acid, or any intravenous corticosteroids within 2 weeks prior to Day 1.
* Have received oral and/or rectal suppository 5-aminosalicylic acid, oral sulphasalazine, or low-dose oral corticosteroids that have been stable for \<4 weeks. Doses of the drugs must remain stable until the last dose of study drug.
* Have received any other concomitant medications for UC that have been stable (ie, have not started dosing with a new drug or had a change to their dosing regimen) for \<7 days or 5 half lives, whichever is longer, prior to Day 1.
* Have Crohn's disease, indeterminate colitis, ischaemic colitis, fulminant colitis, toxic megacolon, chronic pancolitis, or symptomatic intestinal stenosis.
* Have a history of extensive colonic resection (subtotal or total colectomy) or are anticipated to require surgical intervention for UC.
* Have an ileostomy or colostomy.
* Have evidence of treatment for Clostridium difficile infection or other pathogenic bowel infection within 60 days or for another intestinal pathogen within 30 days prior to Day 1.
Phase 1, Open-label, Dose-escalation Trial with CD38-SADA:177 Lu-DOTA Drug Complex in Subjects with Relapsed or Refractory Non-Hodgkin Lymphoma

Patients with non-Hodgkin Lymphoma will be treated with CD38-SADA:177Lu-DOTA complex (The IMP is a two-step radioimmunotherapy, delivered as two separate products CD38-SADA and 177Lu-DOTA) to establish optimal and safe therapeutic doses and dosing schedule of CD38-SADA, and 177Lu-DOTA.


Eligibility Criteria:
Inclusion Criteria:

* Target population must have relapsed, progressive or refractory non-hodgkin lymphoma and be ineligible for or have exhausted standard therapeutic options that may prolong survival
* The subject must have fluoro-deoxyglucose (FDG)-avid lymphoma with measurable disease
* CD38 positive tumor at most recent biopsy (new or archival) documented at central laboratory
* Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
* Each subject must sign an ICF indicating that he or she understands the purpose of, and procedures required for the trial and is willing to participate in the trial.

Exclusion Criteria:

* Primary central nervous system lymphoma or known central nervous system involvement with lymphoma
* Systemic chemotherapy, radiotherapy, immunotherapy, or major surgery administered within 3 weeks (for nitrosoureas within 6 weeks) prior to the first dose of CD38-SADA
* Radioimmunotherapy within 100 days prior to the first dose of CD38-SADA
* Autologous stem cell transplantation within 42 days prior to the first dose of CD38-SADA
* Treatment with approved CAR-T within 100 days prior to the first dose of CD38-SADA
* \>40% lymphoma bone marrow involvement
Multicenter Study of EasyTube® Compared to Endotracheal Tube in General Anesthesia

Evaluation of the EzT in comparison with the endotracheal tube (ETT) for its use during general anesthesia.

There is a recent paper suggesting that general anesthesia with the EzT is feasible and by no means worse than anesthesia with a conventional ETT, and there is little but growing evidence that narcosis with this SAD can be continued during general anesthesia. This brings up several potential benefits: The larger balloons of the EzT are less traumatic to the mucosal tissue compared to a conventional ETT or to a laryngeal mask. Since the insertion of the EzT can be performed without using a laryngoscope, this also reduces tissue damage and tooth injuries caused by a laryngoscope. Also, It has been demonstrated that a similar SAD - the Combitube - can be placed by anesthesiologists with relatively little formal training and that ventilation during elective surgery is feasible. However, such detailed data are missing for the EzT, with only smaller, monocenter-studies available. The next logical step was therefore to systematically evaluate the EzT beyond its purpose as a rescue device in a prospective, randomized multicenter-study to evaluate the use of the EzT in comparison with the ETT during general anesthesia.

Methods 400 patients with ASA status I-II scheduled for elective surgery in 4 centers were randomized to either the EzT group (n=200) or the ETT group (n=200).

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I or II and were scheduled for an elective surgery requiring general anesthesia

Exclusion Criteria:

* Age \< 18 years
* Acute or chronic lung disease
* Patients presenting with sore throat
* Known esophageal disease
* Oropharyngeal abnormalities
* Patients with a cervical spine disease
Improved Motivation for Physical Activity in an Institutionalized Geriatric Population Through a Virtual Environment

The purpose of this study is to test the interest of a virtual environment with cycling to increase the motivation of physical activity practice in institutionalized older adults.

The World Health Organization (WHO) recommends for people aged 65 years and over a weekly practice of at least 150 minutes of moderate-intensity endurance activities or at least 75 minutes of activity. endurance of sustained intensity, or an equivalent combination of moderate and sustained activity. However, the attractiveness for physical activity fades over the years limiting the practice of physical activity. Several types of unconventional approaches have already shown their effectiveness in the prevention of falls in the elderly but these practices find their limits in the lack of adherence to this type of exercise, especially in nursing homes. New virtual reality and gaming technologies have recently emerged and are being used as tools to prevent the risk of falling. The use of these new tools has advantages over conventional exercises: motivating.

The investigators aimed to test the interest of a virtual environment with cycling to increase the motivation of physical activity practice in institutionalized older adults.

Eligibility Criteria:
Inclusion Criteria:

* age over 65
* ability to cycle

Exclusion Criteria:

* unstable cardiopathy
* New York Heart Association classification III or IV
* severe cognitive disorders with inability to follow simple orders (follow investigator, ride on the ergometric bicycles, pedal)
* visual disturbance preventing counting fingers at 5m
Hormones and Cognition in the Menopausal Transition

The purpose of this study is to determine if the menopausal transition is associated with subjective and objective cognitive declines that ameliorate in menopause. The investigators hypothesize that perimenopause is associated with both subjective memory complaints and objective declines in attentionally mediated cognitive tasks. The investigators also hypothesize that this is time-limited. The investigators predict that as women transition from early perimenopause to late perimenopause their performance on attentionally mediated and verbal memory tasks will decline, and that as they transition from late perimenopause to menopause, their performance will improve.

Two groups of women will be recruited, those in early perimenopause and those in mid to late perimenopause. Tests of attention, working memory, mental flexibility, processing speed, and retentive memory will be administered to each subject at 6 month intervals for 5 years. Additionally, women will be asked to fill out questionnaires about their mood, memory functioning, health, and quality of life. The investigators will also calculate each subject's Body Mass Index (BMI) and waist circumference at each visit. Finally, serum levels of reproductive hormones will be taken. Measures of interest will be the percentage of women in each group with absolute and relative cognitive deficits, change over time in performance on neuropsychological tests and scores on depression and anxiety scales, and correlations between cognitive function, mood and hormone level.

Eligibility Criteria:
Inclusion Criteria:

Menopausal status will be based on self-report of menstrual cycles over the past 12 months. Early perimenopause is defined as the presence of irregular periods (cycle length differs by 7 days from usual). Late perimenopause is defined as at least 2 skipped periods over the past 12 months (cycle double usual length) and one period of amenorrhea (over 60 days without a period), with at least one menstrual cycle over the past 12 months, according to the Stages of Reproductive Aging Workshop criteria.

Exclusion Criteria:

- history of neurological disease known to affect cognitive function (i.e., stroke, MS, etc) and major psychiatric illness. The investigators will exclude women who are currently pregnant or breast-feeding, have undergone surgical menopause, or who have used exogenous hormone preparations affecting ovarian or pituitary function in the past 3 months. The investigators will also exclude women who have had hysterectomies, but intact ovaries, or oophorectomies. Women who choose to initiate HRT at some point during the study will continue to be followed, but their data obtained after HRT is initiated will be analyzed separately.
Evaluation of a Decision Aid About Life-sustaining Therapies

Introduction: Clinical practice guidelines recommend shared decision making (SDM) to facilitate goals-of-care discussions. This study will train clinicians about how to use a context-adapted decision aid (DA) and SDM to conduct goals-of-care discussions with the elderly. The objectives of this study are to: 1) determine if the use of the DA and SDM training program: a) increase clinicians' engagement of patients in decision making regarding their goals of care; b) increase adoption of evidence-based behaviours regarding goals-of-care decision making; and 2) identify patients' most frequent incomprehension, concerns, questions and clinicians' opportunities to improve the skills in goals-of-care decision making.

Methods: This study will have three phases. Phase I (May-June 2017) will be a baseline evaluation of the current goals-of-care decision making process with elderly patients in a single ICU setting (Levis, Quebec). Phase II (July-August 2017) will be an evaluation of the goals-of-care decision making process in the same ICU using a DA. Phase III (September-December 2017) will be the delivery of an online and in-person training session about the use of the DA and about how to conduct discussions about goals-of-care. The study will then evaluate the goals-of-care decision making process after completion of the training program and using the DA. The investigators will observe and audio- or video-record all eligible elderly-intensivist dyads discussing goals of care during each phase. Two investigators will analyse the recordings using the OPTION 12 scale (measuring the extent that clinicians engage patients in SDM) and the ACCEPT quality indicators (measuring the extent to which intensivists engage in best practice goals-of-care discussions). The investigators will conduct qualitative content analysis of the video and audio records to identify patients' most frequent incomprehension, concerns, questions and clinicians' opportunities to improve the goals-of-care decision-making skills.

Deliverables: This study will produce evidence regarding the impact of a context-adapted DA and training program on clinicians' adoption of SDM and other best practice behaviors regarding goals-of-care decision making with the elderly, and evidence regarding the most frequent patients' incomprehension, concerns, questions and clinicians' opportunities to improve the goals-of-care decision-making skills.


Eligibility Criteria:
Inclusion Criteria:

1. aged 65 and older,
2. capable of making their own healthcare decisions as determined by the attending intensivist's clinical judgment,
3. in need of a discussion about goals of care as determined by the attending intensivist's clinical judgment.

Exclusion Criteria:

1. intubated patients,
2. patients facing urgent decisions,
3. patients cared by the principal investigator,
4. patients who do not read or speak French.
A Study to Test the Efficacy, Safety, and Tolerability of Bepranemab (UCB0107) in Patients With Mild Cognitive Impairment or Mild Alzheimer's Disease (AD)

The purpose of the study is to investigate the effect of bepranemab versus (vs) placebo on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) up to Week 80 in study participants with prodromal or mild Alzheimer's Disease (AD).


Eligibility Criteria:
Inclusion Criteria:

* 50 to 80 years of age
* Diagnosis of prodromal/mild cognitive impairment (MCI) due to Alzheimer's Disease (AD) or mild AD according to National Institute of Aging-Alzheimer's Association (NIA-AA)
* A global Clinical Dementia Rating (CDR) score of 0.5 to 1.0 and CDR-Memory Box (CDRMB) score ≥0.5 at Screening and Baseline
* Score of ≤85 for the delayed recall domain of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) at Screening
* Mini-Mental State Examination (MMSE) score ≥20 at Screening
* Participant has an identified informant that has and will maintain sufficient contact (minimum of 5 hours per week) with the participant to be able to provide accurate information on the participant's cognitive, functional, and emotional states and of the participant's personal care
* At least 6 years of formal education after the age of 5 or work experience to exclude mental deficits other than prodromal or mild AD dementia
* Evidence of cerebral Aβ accumulation by either positive amyloid assessment by either positron emission tomography (PET) scan or cerebrospinal fluid pTau181/Aβ1-42 ratio assessment

Exclusion Criteria:

* Any evidence of a condition that may affect cognition other than AD
* Contraindications to PET imaging
* Inability to tolerate or contraindication to magnetic resonance imaging
* Any serious medical condition or abnormality that in the opinion of the investigator would preclude safe participation in and completion of the study or interfere with study assessments and/or study interpretation
* Alcohol or drug abuse within 2 years of screening
* Use of any experimental therapy within the past 6 months (or 5 half lives) prior to screening
* Previous treatment with medication intended to treat a neurodegenerative disorder (other than AD) within 1 year of screening
* Chronic daily treatment with atypical antipsychotics, opiates or opioids, benzodiazepines, barbiturates, hypnotics, or any medication with clinically significant centrally acting antihistamine or anticholinergic activitiy
* Received treatment with monoclonal antibodies (mAbs), cytokines, immunoglobulins, or other blood products within 3 months or 5 half-lives (whichever is longer) prior to first dosing
Comparison of Effect of Virtual Reality and Kinetic Chain Exercises in Knee Osteoarthritis

It is necessary to explore the novel rehabilitation strategies to treat knee osteoarthritis. Although kinetic chain exercises have shown efficacy but there is growing interest in Virtual Reality training using Xbox Kinect because it has the potential to enhance motivation and patient's adherence to Rehabilitation. The aim of this study is to compare the effectiveness of both interventions and provide a valuable insight to optimize the therapeutic strategies for treating knee osteoarthritis.

Knee osteoarthritis (OA) is a prevalent musculoskeletal condition that impacts the quality of life. Despite various treatment options, managing knee OA is still a challenge for healthcare professionals. However, there is growing interest in exploring the innovative interventions to decrease symptoms and improve functional outcome in patients with knee OA.The project will be a Randomized control trial conducted to check the effect of Virtual Reality and Kinetic chain exercises in patients with knee osteoarthritis.so that we can have best treatment option. Duration of this study will be of 8 weeks , convenient sampling will be done, subjects following eligibility criteria from IIMCT Pakistan Railway general Hospital will be randomly allocated in two groups, baseline assessment will be done, Group A will be given Xbox kinetic training and Group B will be given Kinetic chain exercises . Outcome measures if this research will be pain , Range if Motion , function and disability. Post intervention assessment will be done via NPRS , WOMAC , KOOS_PS and goniometric measurements of Knee ranges .Data was analyzed by using SPSS software. There is lack of research comparing the effectiveness of Virtual Reality Xbox Kinect and kinetic chain exercises in patients with knee osteoarthritis. There are studies that have explored the effectiveness of these interventions separately. In past, few researches support the fact that virtual reality rehabilitation is more effective than conventional physical therapy and few researches are in support of kinetic chain exercises being more effective for knee osteoarthritis. However there is no study that has compared these both interventions. Therefore there is a need for further research to compare both of these interventions which in future will provide optimal, more personalized and effective rehabilitation strategy for individuals with knee osteoarthritis

Eligibility Criteria:
Inclusion Criteria:

* Both male \& female

  * Age 50 or older.
  * Body mass index (BMI) between 18.9kg/m2 and 29.9 kg/m2.
  * Diagnosed with Grade II knee OA
  * Have knee pain \> 4 on NPRS
  * Ability to engage in moderate physical activity.

Exclusion Criteria:

* Severe comorbidities limiting physical activity.

  * History of Hip and Knee arthroplasty.
  * Cognitive impairments affecting comprehension