cyrilzakka/clinical-trials huggingface dataset:
LYNG21: Ably LYNG Clinical Demonstration in Operative Environment

The study main objective will be to compare measurements of heart rate, respiration rate, blood pressure and movement done by LYNG by Ably Medical with the corresponding measurements made by standard equipment in a patient sample in a hospital setting. The comparison will show the degree of agreement between LYNG and the existing current standard equipment. Data from the study will support Ably Medical in optimizing the LYNG product and measurement precision.

The LYNG sensor mat is placed beneath a regular bed matrass and captures data without direct patient contact. Data collected by the LYNG sensor is transmitted via cables to the bed-side connectivity box for initial local analysis and storage. Data will be extracted and formatted for post-analysis in additional software for verification and validation purposes.

Specifically, the LYNG study objectives are as follows:

1. collect sensor data from LYNG Solution to optimize the LYNG data algorithms to further improve parameter estimations of patient heart rate, respiratory rate, blood pressure and movement indicators.
2. Compare parameter estimation by LYNG against current and relevant standard of care measurement methods

The study design is a within-subjects comparison in parameter estimation with Ably LYNG as comparator to standard of care. Patients will take part in 60-minute sessions where measurements are collected in accidence to standard procedure for the standard equipment while the LYNG system collects the same data non- intrusively. The data will not be part of any clinical decision making or have any impact of the patient care. The study will take place during Q2-Q3/2021 with estimated 8-12 weeks duration including logistics, setup, data collection, study closure.

Eligibility Criteria:
Inclusion Criteria:

* For patients:

  * Admitted to hospital,
  * Able to provide voluntary, informed consent.

Exclusion Criteria:

* For patients:

  * Health condition that endangers patient by participation due to pain, rehabilitation, and/or negative impact on treatment or care, as evaluated by medical personnel,
  * Pregnancy,
  * Significantly reduced mobility that implies substantial strain for moving in and out of bed, as evaluated by medical personnel
  * Unable to provide informed, voluntary consent personally or by legal guardian, \* below 18 years old,
  * Patients with implantable devices such as pacemakers, baclofen pumps, insulin pumps, etc, or
  * Any way identified as 'vulnerable'

The nurse handing recruitment will explicitly check for inclusion/exclusion criteria alignment and document this in the study Enrolment Form. The routine will be to check for formal criteria and to describe the study in such a manner that the patient understands content, and make sure the patient understands before consenting
A Study to Evaluate the Safety and Efficacy of TS-121 as an Adjunctive Treatment for Major Depressive Disorder

The purpose of this study is to evaluate the safety, tolerability, and efficacy of TS-121 as an adjunctive treatment for patients with major depressive disorder with an inadequate response to current antidepressant Treatment (SSRI, SNRI or bupropion).


Eligibility Criteria:
Inclusion Criteria:

1. Adult males and females between 18 and 65 years of age inclusive (at time of initial informed consent)
2. Patients with a current diagnosis of MDD by DSM-5, confirmed through a structured interview using MINI
3. Patients who receive the same antidepressant (SSRI, SNRI or bupropion monotherapy) for at least 6 weeks of continuous treatment with at least 4 weeks on a fixed dose
4. Patients who willing to remain on the same primary SSRI, SNRI or bupropion and fixed dose throughout the course of the study
5. Patients who meet the total score on the HAM-D as listed below

   1. HAM-D ≥ 18 at Screening
   2. HAM-D ≥ 18 at Baseline
6. Body Mass Index (BMI) ≥ 18 and ≤ 38 kg/m2

Exclusion Criteria:

1. Patients with inadequate response to ≥2 prior antidepressant treatments (not including current antidepressant) of at least 4 weeks duration each for the current episode
2. Patients whose current depressive episode is diagnosed with psychotic features, catatonic features, post-partum (primary onset), or is secondary to a general medical disorder
3. Patients with a diagnosis of any of the following DSM-5 class disorders

   1. Schizophrenia spectrum and other psychotic disorders
   2. Bipolar and related disorders
   3. Anxiety disorders \[Co-morbid GAD and SAD will be allowed in the study if the primary diagnosis is MDD, and if in the opinion of the investigator, the comorbid anxiety is not likely to interfere with the subject's ability to participate in the trial or affect study outcome\]
   4. Obsessive-compulsive and related disorders
   5. Trauma- and Stressor-related disorders
4. Patients who received electroconvulsive therapy (ECT) within 12 months of Screening, received more than one course of ECT in their lifetime or plan to receive ECT during the study
5. Patients who received repetitive transcranial magnetic stimulation (rTMS) within 12 months of Screening or plan to receive rTMS during the study
6. Patients who plan to initiate or terminate cognitive or behavioral psychotherapy or alter the frequency of ongoing therapy during this study
7. Patients who have attempted suicide within the past 6 months
8. Patients with history or presence of intellectual disability, pervasive developmental disorder, cognitive disorder, neurodegenerative disorder, or brain injury
9. Patients with any history or complication of convulsive disorder
10. Patients who are undergoing treatment with psychotropic medications, benzodiazepines, metyrapone, lithium and/or corticosteroids
11. Patients who are taking moderate to strong CYP3A4 inhibitors/inducers
ClearUP Longitudinal Pilot Study

Single arm, open label pilot study assessing the longitudinal home use of ClearUp Sinus Pain Relief for four weeks.


Eligibility Criteria:
Inclusion Criteria:

* 18-71 years of age (inclusive)
* Present with symptoms of sinus pain or facial pain in the forehead, periorbital, facial, or nasal region
* Current pain score ≥ 5 (Numeric Rating Scale 0-10)
* Frequency of sinus/facial pain at least twice weekly for 1 month
* Able to read and understand English
* Agree to participate in the study
* Able and willing to provide Informed Consent

Exclusion Criteria:

* Do not meet Inclusion Criteria
* Currently taking or recently taken any oral steroid medications in the last 90 days
* Sinus surgery in previous 90 days
* History of Chronic Migraine (≥ 15 headache days per month)
* Pain location in the vertex, occiput, or temporal region of the skull or in mandibular region
* Purulent rhinorrhea
Telephone Counseling for Pregnant Smokers

This purpose of the study was to investigate the efficacy of telephone counseling to help pregnant women quit smoking. The investigators tested two hypotheses: 1) telephone counseling increases the overall cessation rate during pregnancy, and 2) the counseling effects can be maintained postpartum.

Smoking during pregnancy increases the risk of low birth weight, premature delivery, fetal and infant death, and children's developmental problems. It is also associated with significant economic costs. Telephone cessation quitlines have been suggested as one good way to reach pregnant smokers.

This randomized controlled trial was embedded into a free statewide telephone cessation quitline in California. The primary component of the intervention was telephone counseling using a structured protocol developed specifically for the pregnant population. The counseling consisted of nine counseling sessions.

A secondary component of the intervention was the mailed materials. Following enrollment in the study all subjects (control and intervention) received a self-help quit kit for pregnant smokers and fact sheets on second-hand smoke and additional tips for quitting while pregnant. Subjects in the counseling intervention group received five additional mailings. These mailings were designed to remind them of their commitment to quitting and of the presence of counseling support if they needed help.

Prior to 36 weeks gestation (in the third trimester), 2-months postpartum, and 6-months postpartum we conducted a brief telephone survey to assess smoking status. The information obtained allowed us to determine 30-day prolonged abstinence rates.

Prior to 36 weeks gestation (in the third trimester), the investigators sent a kit and requested saliva samples be mailed back to biochemically verify smoking status by testing for cotinine and nicotine byproducts.

Eligibility Criteria:
Inclusion Criteria:

* Current smoker willing to quit within one month
* Recent quitters
* First time quitline caller
* Less than 27 weeks gestation
* English and/or Spanish speaking
* Valid phone number
* Valid address
* Gave consent to participate in study and evaluation

Exclusion Criteria:

* Active psychiatric disorder
* Substance or alcohol abuse
* Had been in recovery from alcohol or other substances for less than 6 months
* Planned to use pharmacotherapy
* Insufficient contact information
Effect of Fingolimod on the Cardiac Autonomic Regulation in Patients With Multiple Sclerosis

The purpose of this study is to study the effect of fingolimod on cardiac autonomic regulation in patients with relapse-remitting multiple sclerosis.

This will be done by measuring heart rate variability from the 24-hour Holter recording and myocardial ventricular repolarisation patterns from the 12-lead electrocardiogram tracings.

The fingolimod treatment is prescribed according to the accepted drug label.

The study will include 30 relapse-remitting multiple sclerosis patients. Assessments of heart rate variability and myocardial ventricular repolarisation pattern will be done 1) before fingolimod, 2) first day of fingolimod 3) after 3 months use and 4) after 12 months use of fingolimod.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 65 years
* Understands the proposed research and actions to be taken
* The written informed consent has given
* clinical indication to fingolimod-treatment

Exclusion Criteria:

* Patient refuses
* Patient takes or has taken part in other clinical drug trial during the last month
* No clinical indication to the use of fingolimod
* Contraindication to the use of fingolimod
A Research Study Looking at How a Single Dose of the Study Medicine NNC0194-0499 Behaves in Participants With Reduced Liver Function Compared to Participants With Normal Liver Function

The study medicine NNC0194-0499 is under development for non-alcoholic fatty liver disease (NAFLD) including non-alcoholic steatohepatitis (NASH). All participants will receive a single dose of 30 milligram (mg) of the study medicine. The study medicine will be given in the form of an injection of 0.6 millilitres in a skinfold of the thigh (subcutaneous). The study will last for up to 64 days. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period. Women who are able to become pregnant must use highly effective contraception and will be counselled on the use of contraception. Participants with impaired liver function will undergo an ultrasound of the belly and measurement of brain activity.


Eligibility Criteria:
Inclusion Criteria:

* Male or female.
* Aged 18-80 years (both inclusive) at the time of signing informed consent.
* Body mass index (BMI) between 18.5-39.9 kilogram per square meter (kg/m\^2) (both inclusive). Specific inclusion criterion only for participants with hepatic impairment:
* Participants with stable hepatic impairment classified as Child-Pugh grade A, B or C as assessed by the investigator. Stable hepatic impairment is defined as no clinically significant change in disease status, as judged by the investigator.

Exclusion Criteria:

* Known or suspected hypersensitivity to study intervention(s) or related products.
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.
Safety of Single and Repeat Treatments of DaxibotulinumtoxinA for Injection for Treatment of Moderate to Severe Glabellar Lines

This is a long term safety study of DaxibotulinumtoxinA for Injection for the treatment of moderate to severe glabellar lines following single and repeat administration.


Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent including authorization to release health information
* Moderate (2) or severe (3) glabellar lines during maximum frown based on the Investigator Global Assessment Frown Wrinkle Severity (IGA-FWS) scale
* Moderate (2) or severe (3) glabellar lines during maximum frown based on the Patient Frown Wrinkle Severity (PFWS) scale
* Willing and able to follow all trial procedures, attend all scheduled visits, and successfully complete the trial

Exclusion Criteria:

* Any neurological condition that may place the subject at increased risk with exposure to botulinum toxin type A, including peripheral motor neuropathic diseases such as amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders such as Lambert-Eaton syndrome and myasthenia gravis
* Active skin disease, infections or inflammation at the injection sites
* Plan to receive botulinum toxin type A anywhere in the face through the duration of the study
* History of allergy or sensitivity to any botulinum toxin preparations or to any component of the test article
* Current enrollment in an investigational drug or device trial or participation in such a trial within the last 30 days prior to screening through end of trial
Healthy Life for Frail Malnourished Seniors Performed Together With Trained Lay Buddies

Background: In elderly subjects frailty and malnutrition are very common and can lead to serious health hazards, increase mortality, morbidity, dependency, institutionalization and a reduced quality of life. In Austria, the prevalence of frailty and malnutrition are increasing steadily and are becoming a challenge for our social system. Physical training and adequate nutrition can invert it.

Methods/Design: In this randomized, controlled trial 80 malnourished, frail, community-dwelling patients (≥ 65 years) are recruited. Additionally, 80 lay volunteers (≥ 50 years) named buddies are recruited and subsequently trained regarding health enhancing physical activity and nutrition in three standardized training sessions. These buddies visit the malnourished, frail subjects at home twice a week for about one hour during an initial period of 10-12 weeks. While participants allocated to the intervention group (n=40) conduct intervention to improve their fluid intake, their protein and energy intake, perform strength training and try to increase their baseline activities, the control group (n=40) only gets home visits without any special intervention. After 10-12 weeks, both, the intervention and the control group, receive the nutrition intervention and the physical training. Health, nutrition and frailty status, physical fitness and body composition and chronic inflammation of buddies and frails are recorded before the intervention, after 10-12 weeks, and after 6 and 12 months.

Discussion: To the investigators knowledge this trial is the first of its kind to provide nutrition and physical activity intervention to malnourished, frail, community-dwelling subjects by trained lay buddies, in which the health status of buddies is also expected to improve. This study assesses the effectiveness of such an intervention. If successful, the intervention offers new perspectives for the management of frailty and malnutrition.


Eligibility Criteria:
Inclusion Criteria frail, malnourished subjects:

* 65 years or older
* Living in Vienna
* Hospital discharged planned for the next 14 days
* Malnutrition or at risk of malnutrition according to the MNA-SF
* Frail or pre-frail according to the SHARE-FI
* Community-dwelling
* No medical contraindication for the performance of physical strength training
* Able to walk (with or without a walking aid)
* Capability to consent

Exclusion Criteria frail, malnourished subjects:

* 65 years or younger
* Admission to nursing home is planned
* Nursing level 6 or 7
* Cancer according to the medical charts
* Insulin treated diabetes mellitus according to the medical charts
* COPD stage III or IV
* Dialysis patient
* Cannot understand the German language
* Impaired cognitive function according to the MMSE (≤ 17 points)

Inclusion Criteria buddies:

* 50 years or older
* Signed informed consent
* Readiness to participate in the study as well in the intervention as in the control group
* Commitment to keep to the protocol for at least 6 months
Anterior Glenoid Nerve Block Versus Pericapsular Nerve Group Block Versus Interscalene Brachial Plexus Block for Postoperative Pain Management in Shoulder Arthroscopic Surgeries

This study aims to compare between Anterior glenoid nerve block, pericapsular nerve group (PENG) block and Interscalene brachial plexus (ISB) block for post-operative pain management in shoulder arthroscopic surgeries

Major surgeries of the shoulder constitute some of the most commonly performed orthopedic procedures. They often result in moderate to severe postoperative pain thereby requiring a multimodal analgesic approach centered around peripheral nerve blocks.

Postoperative pain management is the part of shoulder surgery to improve patient satisfaction, start rehabilitation process rapidly and decrease for hospital stay.

Interscalene blocks (ISB) are well-studied and established means of providing analgesia following shoulder surgery and are considered the gold standard mode of regional anesthesia and post-operative pain management in shoulder surgeries.

A novel technique: pericapsular nerve group (PENG) block can be effectively and safely applied under ultrasound guidance in shoulder surgery cases for postoperative analgesia. In addition, PENG block targets articular branches with less motor effect compared with interscalene brachial plexus block providing anesthetic and analgesic effect with less complication and better and sooner ambulation.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 70 years.
* No sex predilection.
* American Society of Anesthesiology (ASA) physical status I-II.
* Undergoing shoulder arthroscopic surgeries.

Exclusion Criteria:

* Patient's refusal.
* Patients with a history of drug allergies to study drugs.
* Evidence of local infection at the site of injection.
* Inability to cooperate
* Neuromuscular pathology (example: - Multiple Sclerosis)
* Previous trauma or surgery to the shoulder
Vistusertib (AZD2014) Monotherapy in Relapsed Small Cell Lung Cancer Patients Harboring RICTOR Amplification

\[Study Design\] This study is a single arm, multi-center phase II study of vistusertib monotherapy in patients with relapsed small cell lung cancer (SCLC) harboring RICTOR amplification. Patients will receive vistusertib monotherapy (50 mg BID per os every 12 hours) until they demonstrate objective disease progression or they meet any other discontinuation criteria.

\[Primary Objective\] To investigate the efficacy of vistusertib monotherapy in patients with relapsed SCLC patients harboring RICTOR amplification as 2nd or 3rd line therapy


Eligibility Criteria:
\[Inclusion Criteria\]

* Provision of informed consent prior to any study specific procedures
* Men and women aged at least 18 years
* Small cell lung cancer harboring RICTOR amplification
* Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no deterioration over the previous 2 weeks
* Minimum life expectancy of 12 weeks
* Patients must have acceptable bone marrow, liver and renal function measured within 14 days prior to administration of study treatment as defined below:
* At least one measurable lesion that can be accurately assessed by imaging or physical examination at baseline and follow up visits.
* No history of non-autologous bone marrow transplant.

Exclusion Criteria:

* Participation in another clinical study with an investigational product during the last 21 days.
* Prior chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents within 21 days of starting study treatment. Prior use of an investigational monoclonal antibody therapy within 3 months.
* Major surgery within 4 weeks prior to study entry (excluding placement of vascular access), or minor surgery (excluding tumour biopsies) within 14 days of first dose of study treatment.
* Exposure to strong or moderate inhibitors or inducers of CYP3A4/5, Pgp (MDR1) and BCRP if taken within the stated washout periods before the first dose of study treatment (see Appendix 1)
* Exposure to specific substrates of the drug transporters OATP1B1, OATP1B3, MATE1 and MATE2K within the appropriate wash-out period
* Any haemopoietic growth factors within 14 days prior to receiving study treatment.
* Pre-treatment with other PI3K, AKT, dual PI3K/mTRO and mTOR inhibitors
* Spinal cord compression and/or brain metastases unless asymptomatic or treated and stable off steroids for at least 4 weeks prior to start of study treatment.
The Effect of Neurodynamic Mobilization Exercise on Lower Limb Pain in Patients With Rheumatoid Arthritis.

This clinical trial is the first study to apply neurodynamic mobilization, a nervous system specific therapeutic exercise, on patients with rheumatoid arthritis(RA). Objective of the study is to find out the effect of neurodynamic mobilization for joint inflammation in patients with RA.

Rheumatoid arthritis (RA) is a chronic autoimmune disorder characterized by generalized joints inflammation. With increasing investigation on the pathology, the treatment focus on the conditions shifted from a musculoskeletal point of view to a systemic approach. The awareness of holistic treatment was also increased.

Latest studies have found out the neurogenic inflammatory mechanism played an important role in the inflammatory process of RA, the pathological changes of neural tissues in RA were also noted.

This clinical trial is the first study to apply neurodynamic mobilization, a nervous system specific therapeutic exercise, on patients with RA. Objective of the study is to find out the effect of neurodynamic mobilization for joint inflammation in patients with RA.

Population Adults who are diagnosed with Rheumatoid Arthritis.

Intervention Neurodynamic Exercise

Comparison Standard conservative physiotherapy protocol

Outcome Rheumatoid Arthritis Pain Scale (RAPS) C-reactive protein (CRP) test

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria was considered as patients with rheumatoid arthritis; presence of inflammatory condition on the joints on upper and / or lower limbs; Rheumatoid Arthritis Pain Scale (RAPS) at least 10 points during activities of daily living; and adults (\> 18 years of age) in either gender.

Exclusion Criteria:

* The exclusion criteria are: acute joint pain, physiotherapy or joint injections in the previous 3 months; change in corticosteroids in the previous month; and change in disease-modifying antirheumatic drugs in the previous 3 months; subjects with poor balance or significant pain which neurodynamic mobilization is unable to perform.
Impact of the Profession on Parenthood

Professional constraints can have major causes on personal and couple life. In particular, some professions with major professional constraints that can be particularly impacted, such as doctors and healthcare workers.

The main objective was to demonstrate the impact of work on the desire and the fact to have children

This is an observational study by questionnaire via an internet link. The self-questionnaire will assess parenthood, socio-demographic parameters, and the perception of the profession.

Eligibility Criteria:
Inclusion Criteria:

* All volunteers
* Workers or retirees

Exclusion Criteria:

* none