cyrilzakka/clinical-trials huggingface dataset:
Do the SPPB and 4-metre Gait Speed Predict Hospital Readmission in Patients Hospitalised for Acute Exacerbation if COPD?

This study aims to evaluate simple tests of physical function in hospitalised patients with chronic obstructive pulmonary disease (COPD) and to assess whether they can predict future hospital readmission. The Short Physical Performance Battery (SPPB) is a simple test of standing balance, usual walking speed (4-metre gait speed) and ability to stand from a chair, which reflects global physical functioning and frailty.

We hypothesise that the SPPB or 4-metre gait speed can predict future hospital readmissions.


Eligibility Criteria:
Inclusion Criteria:

* Hospital admission with an exacerbation of COPD
* Must have capacity to consent
* Able to walk

Exclusion Criteria:

* Co-morbibities that limit walking ability
* Co-morbidities that make walking unsafe
Return to Performance Criteria Following Shoulder Instability Surgery in the Athlete.

The purpose of this study is to determine whether certain criteria for returning to the field can be predictive of a return of the athlete to a level of performance similar to that of before his shoulder injury. In this context, these different criteria will be tested at 6 months in post-surgery while performance monitoring will be carried out at 12, 18 and 24 months.


Eligibility Criteria:
Inclusion Criteria:

* Athletes playing sports soliciting the upper limb (\> 3 hours per week)
* Athletes between 18 and 35 years of age
* Patients with recent Bankart or Latarjet shoulder surgery (less than 4 months ago)
* Patients accepting the study protocol

Exclusion Criteria:

* Patients with other pathologies that interfere with planned physical activity.
A Study on the Status Quo of Physical Exercise for the Elderly

Through interview, taking the elderly community in Beijing as an example, this study will try to further understand the current physical exercise situation of the elderly in the community, and analyze the factors influencing their participation degree. By this way, we will try to provide constructive suggestions for the development and design of universal community physical exercise programs for the elderly.


Eligibility Criteria:
Inclusion Criteria:

1. Regardless of gender, age ≥ 65 years old
2. Lived in Beijing for a long time
3. Normal listening, speaking, and comprehension skills

Exclusion Criteria:

1. Accompanied by significant cognitive dysfunction
2. Diseases that seriously affect their participation in sports, such as fractures, tumors, neurological diseases, etc.
Osseous Resective Surgery Vs Conservative Surgery with or Without Papilla Preservation Technique

The primary aim of the study is to evaluate the efficacy of either fibre retention osseous resective surgery (FibReORS) or conservative surgery with or without PPT in the treatment of deep residual pockets ≥ 6 mm in stage III-IV periodontitis patients after cause related therapy (step II) in terms of endpoints of therapy and other secondary outcomes at different time intervals (1, 3 and 5 years). Moreover, the study aims to evaluate the stability of the results obtained for the different surgical approaches over a 5 years follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of stage III/IV periodontitis.
* Completed steps I-II periodontal therapy at least 6 weeks before.
* Full Mouth Plaque Score less than 15% at re-evaluation.
* Full Mouth Bleeding Score less than 15% at re-evaluation.
* Posterior sextant with residual PPD ≥ 6 mm at ≥ 2 natural teeth (third molars excluded).
* Signed informed consent.

Exclusion Criteria:

* Compromised general health which contraindicates the study procedures (ASA III-VI patients).
* Systemic diseases/medications which could influence the outcome of the therapy (e.g. uncontrolled diabetes mellitus, non-plaque-induced gingival diseases, antiepileptic drugs (phenytoin and sodium valproate), certain calcium channel-blocking drugs (e.g., nifedipine, verapamil, diltiazem, amlodipine, felodipine), immunoregulating drugs (e.g., ciclosporine), and high-dose oral contraceptives).
* Pregnant or nursing women.
* Presence of tooth mobility ≥ class 2.
* Presence of furcation involvement ≥ II degree (Hamp 1975) at the affected teeth.
* Presence of deep infrabony defects (≥ 3 mm) at the involved sextant.
A Dose Escalation and Dose Expansion Study of NOX66 in the Treatment of COVID-19

Phase Ib, open-label, multicenter, study of NOX66, given rectally to hospitalized patients with moderate systemic illness due to COVID-19 infection at high risk of developing severe sepsis / septic shock.


Eligibility Criteria:
Key Inclusion Criteria:

1. Hospitalized patient with clinically diagnosis of SARS-CoV-2 virus infection per World Health Organization criteria including positive nucleic acid test of any specimen (e.g., respiratory, blood, or other bodily fluid) within 2 weeks prior to screening.{Other confirmatory test results will be accepted upon approval from Sponsor/CRO Medical Monitor prior to enrolment}.
2. Symptoms suggestive of moderate systemic illness with COVID-19, which could include any of the following symptoms: fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath at rest, or respiratory distress.
3. Clinical signs indicative of moderate systemic COVID-19 illness (with high risk of developing severe ARDS/septic shock) with an aggregate of NEWS-2 score of 4-6 or 3 in one single parameter.

Key Exclusion Criteria:

Patients who meet any of the following criteria will be disqualified from entering the study:

1. Patients who require endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates \>20 L/min with fraction of delivered oxygen ≥ 0.5), non-invasive positive pressure ventilation, ECMO, or clinical diagnosis of respiratory failure.
2. Presence of any of the following abnormal laboratory values at screening: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>5 x upper limit of normal (ULN), platelets \<50,000/µL.
3. Treatment with anti-IL 6, anti-IL-6R antagonists, or with Janus kinase inhibitors in the past 30 days or plans to receive during the study period.
4. Current treatment with conventional synthetic disease-modifying antirheumatic drugs (DMARDs)/immunosuppressive agents.
5. Use of chronic oral corticosteroids for a non-COVID-19-related condition in a dose higher than prednisone 10 mg or equivalent per day.
6. History of, or current autoimmune or inflammatory systemic or localized disease(s) other than rheumatoid arthritis.
Recruitment Maneuver Using Lung Ultrasound in Trauma Patients

In trauma patients, the incidence of pulmonary contusion is frequent. Recruit maneuver using lung ultrasound could be improve oxygenation in trauma populatioin, howevere, there is no previous study. The aim of this study is evaluation of the efficacy of lung recruitment using ultrasound in perioperative period in trauma patients.

In trauma patients, the incidence of pulmonary contusion is 17-75%. Pulmonary contusioin leads to atelectasis, lung consolidatioin. Finally it could results acute respiratory distress syndrome.

Lung ultrasound is non-invasive and available in anytime even during surgery. Previous studies showed recruitment maneuver using ultrasound improved postoperative oxygenation in pediatric cardiac surgery. In adults, recruitment maneuver not using ultrasound improved oxygenation after cardiopulmonary bypass. There is no study in adult trauma population.

The aim of this study is evaluation of the efficacy of lung recruitment using ultrasound in perioperative period in trauma patients.

Eligibility Criteria:
Inclusion Criteria:

* Who need surgery under general anesthesia due to trauma
* The position of the surgery is supine

Exclusion Criteria:

* Who has been ventilator care before the surgery
* Thoracic surgery
* Who had cardiopulmonary resuscitation
* Who has acute respiratory distress syndrome
Evaluating the Pulmonary Nodule With Imaging and Biomarkers

The study aims to determine if there are defining EBUS and confocal endoscopy features as well as exhaled alveolar gas VOC that can discriminate malignant pulmonary nodules or masses from benign etiology, thereby obviating unnecessary thoracotomy. Directly sampled alveolar gas VOC from patients with lung cancer will be compared against exhaled breath VOC for signature compounds that may complement CT in screening the population at risk.

AIMS

1. To improve diagnostic yield of pulmonary nodule or mass by using combined approach of navigation bronchoscopy and EBUS.
2. To determine if characteristic features of EBUS and confocal microendoscopy exist as well as VOC patterns in alveolar and exhaled gas that can aid in discriminating malignant pulmonary nodule or mass from benign etiology by correlating with pathology.
3. To identify VOC patterns specific for lung cancer by correlating VOC from directly sampled alveolar gas and exhaled breath with pathology. Exhaled breath VOC signature may complement CT in screening population at risk.

Eligibility Criteria:
Inclusion Criteria:

* All patients aged above 21 years, capable of giving consent and suspected of lung cancer with radiological lung nodules and masses.

Exclusion Criteria:

* Patients with contra-indications to bronchoscopy and CT-TTNA that include active myocardial ischemia, uncorrected coagulopathy, severe respiratory distress, uncontrollable cough, and pregnancy will be excluded. Before females in the reproductive age are recruited, urine pregnancy test will be performed and confirmed negative.
An Observational, Retrospective Multicentre Medical Record Review to Describe the Post-authorisation Early Clinical Experience of Dupilumab in the Treatment of Adult Severe Asthma

The purpose of this retrospective medical record review is to describe the real-world clinical effectiveness of dupilumab with patients in the United Kingdom with severe asthma.

Participants initiating treatment with dupilumab in the UK between 5th July 2019 and 12th August 2021 will be included in the study record review, permitting participation in research and if medical records are available for review. No intervention will be administered in this clinical trial. Data will be collected from hospital medical records and other hospital databases.

Eligibility Criteria:
Inclusion Criteria:

• Adult participants (aged ≥18 years at index) with severe asthma, initiated with dupilumab treatment (≥1 dose) between 07/05/2019 (EU licence) and 08/12/2021 • Participants with ≥1 routine asthma clinic visit recorded within 6 months prior to or on the date of dupilumab initiation and ≥1 routine asthma clinic visit recorded between 9 and 16 months post-dupilumab initiation

Exclusion Criteria:

• Participants known to have opted out of participation in research • Participants whose medical records are not available for review The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Routine Lymphadenectomy for Intrahepatic Cholangiocarcinoma

The role of routine lymphadenectomy (LND) in the surgical treatment of intrahepatic cholangiocarcinoma (ICC) remains controversial. The investigators' multi-institutional retrospective study have showed an increasing adoption of LND among patients undergoing curative resection for ICC during the last decade. The current prospective and randomized study based on a multi-institutional collaboration would investigate whether routine LND would benefit patients in short- and long-term survival remains.

Intrahepatic cholangiocarcinoma (ICC) is the second most common primary liver cancer and its incidence is increasing worldwide.Resection of the primary ICC tumor site within the liver represents the best curative treatment option. However, the role of lymphadenectomy (LND) at the time of surgery remains controversial with some centers considering it standard while other surgeons perform LND only in select circumstances. The utilization of LND may not only vary among different institutions, but also by geographic region. Specifically, data from East and West centers have noted a variation in the utilization of LND ranging 27%-100%.While several case series from Asia have noted that most centers do not regularly perform LND,other data from the West suggest that LND may be becoming more routine. Despite the lack of consensus among surgeons, the American Joint Committee on Cancer (AJCC) Staging manual recommends that the nodal basin be staged. Disease-specific staging for ICC was first introduced in the 7th edition of the AJCC staging manual published in 2010. The newly updated 8th edition of the AJCC staging system now recommends that 6 lymph nodes be evaluated to stage a patient with ICC.

The previous multi-institutional retrospective study from the investigators have showed an increasing adoption of LND among patients undergoing curative resection for ICC during the last decade. The current prospective and randomized study based on a multi-institutional collaboration would investigate whether routine LND would benefit patients in short- and long-term survival remains.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with intrahepatic cholangiocarcinoma by imaging or biopsy
* The tumor is limited in the liver with no distant metastasis, and the primary disease is resectable
* Preoperative imaging (e.g. CT, MRI, PET-CT, etc.) and intraoperative exploration found no nodal swelling or enlargement

Exclusion Criteria:

* The primary disease is unresectable with or without distant metastasis
* The liver function or general condition of patients does not permit surgery
* Preoperative imaging (e.g. CT, MRI, PET-CT, etc.) and intraoperative exploration found obvious nodal swelling or enlargement, which indicates lymphadenectomy should be performed
* Patients aged below 18 or older than 65 would be excluded
* Pregnant women would not be enrolled
Effectiveness of Manual Myofascial Release Versus Instrument Assisted Soft Tissue Mobilization (IASTM) in Patients With Chronic Neck Pain"

Neck pain has a global prevalence of 30%, being the fourth leading cause of disability among general population and is more prevalent among females than males, as per concluded by evidence. It is undoubtedly the need of time, to address its proper treatment and to hinder its recurrence amongst the general population. The current physical therapy management of neck pain is more focused towards achieving the short term goals for the patient rather than addressing and amending the actual cause of its relapse. Manual Myofascial Release is one of the very effective treatment used to release soft tissue and fascial adhesions over the myofascia inorder to relieve chronic neck pain. The study aims to compare this manual treatment against Instrument Assisted soft tissue mobilization in order to determine which of the two provides improved outcome in terms of pain, neck disability and cervical Range of motion.


Eligibility Criteria:
Inclusion Criteria:

* Male and Female participants belonging to the age group of 18 to 40 years
* Participants suffering from neck pain for more than 3months.

Exclusion Criteria:

* Recent history of Whiplash Injury.
* Recent traumatic history of head, cervical spine, shoulder girdle or fractures of the cervical spine or shoulder complex.
* History of Cervical Radiculopathy, spondylosis, spondylolisthesis, disc prolapse, any other systemic disease or vascular syndrome such as vertebro-basilar Insufficiency.
* Diagnosed Fibromyalgia, myopathy or myelopathy
* Sensory/Motor dysfunction owing to any neurological pathology in the mid or upper back.
Zinc Sulfate in Preventing Loss of Sense of Taste in Patients Undergoing Radiation Therapy for Head and Neck Cancer

RATIONALE: It is not yet known whether zinc sulfate is effective in preventing the loss of ability to taste food in cancer patients who are undergoing radiation therapy for head and neck cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of zinc sulfate in preventing loss of sense of taste in patients who are undergoing radiation therapy for head and neck cancer.

OBJECTIVES:

* Determine whether zinc sulfate prolongs the time to onset of altered taste in patients with head and neck cancer undergoing radiotherapy.
* Determine whether this drug decreases the overall incidence of altered taste in these patients.
* Determine whether this drug results in fewer radiotherapy treatment interruptions in these patients.
* Assess the quality of life of patients treated with this drug.
* Determine the toxic effects of this drug in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to planned radiotherapy dose (less than 6,000 cGy vs at least 6,000 cGy), estimated amount of oral mucosa in the radiation field (60% or less vs more than 60%), age (under 50 vs 50 and over), concurrent chemotherapy (yes vs no), and smoking (yes vs no). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral zinc sulfate 3 times daily beginning the first week of radiotherapy.
* Arm II: Patients receive oral placebo 3 times daily beginning the first week of radiotherapy.

Treatment in both arms continues daily during and for 1 month after radiotherapy in the absence of unacceptable toxicity.

Quality of life is assessed at baseline, weekly during treatment, and then at 1, 2, 3, and 6 months after the completion of treatment.

Patients are followed at 1, 2, 3, and 6 months after the completion of treatment and then every 6 months for 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of head and neck cancer
* No stage I laryngeal cancer
* Planned treatment with at least 2,000 cGy of external beam radiotherapy to at least 30% of the oral cavity

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-2

Life expectancy:

* At least 3 months

Gastrointestinal:

* Able to tolerate oral medication
* No known mechanical obstruction of the alimentary tract
* No malabsorption
* No intractable vomiting (more than 5 episodes per week)

Other:

* No known intolerance to zinc sulfate
* No known, untreated oral thrush
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Surgery:

* No prior surgery that included ablation or removal of the olfactory component of taste

Other:

* No concurrent zinc supplements

  * Concurrent standard multivitamins allowed
Bioavailability of Doravirine (MK-1439) Experimental Nano Formulations in Healthy Adults (MK-1439-046)

This study aims to evaluate and compare the relative bioavailability of different doravirine (MK-1439) experimental nano formulations (NFs) with that of a doravirine film coated tablet.


Eligibility Criteria:
Inclusion Criteria:

* healthy participants
* have been a non-smoker and/or have not used nicotine or nicotine-containing products for at least approximately 3 months

Exclusion Criteria:

* is a pregnant or a nursing female
* has a history of stroke, chronic seizures or major neurological disorder
* has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
* has a history of neoplastic disease (including leukemia, lymphoma, malignant melanoma), or myeloproliferative disease
Psychological Well-being of Patients Awaiting for Cardiac Surgery During the COVID-19 Pandemic

The effect and impact of postponing cardiac surgery / creating a waiting list as a result of COVID-19 on patients, both psychologically and symptomatically on three groups of patients:

1. The degree of anxiety and/or depression induced by their altered medical care trajectory.
2. The incidence of medical problems induced by deferred elective surgery or delayed postoperative ambulatory visit
3. The occurrence of reduced access to medical and psychological help

A prospective study by means of a questionnaire, specifically designed for each of the three groups.

1. Adult patients whose operation date has been deferred
2. Patients who did not have had an operation date
3. Patients who have been operating on during the month before

Each group will receive a twofold questionnaire:

Part I: Hospital Anxiety and Depression Scale (HADS), a robust questionnaire used for hospitalized and non-hospitalized patients gauging the degree of anxiety and/or depression, irrespective of their specific medical condition. All three groups receive the same list of questions.

-Part II: a questionnaire made up specifically for issues concerning the medical/psychological/access aspects during the COVID-19 outbreak. Each of the three groups will receive a questionnaire, adapted to the group they are assigned to.

The questionnaires will be delivered by the use of Qualtrics or on paper. Timing and mode of presentation (Qualtrics or fill-in paper on admission) of the questionnaire will depend on the length of the quarantine measures.

Eligibility Criteria:
Inclusion Criteria:

All adult patients whose operation date has been deferred due to the pandemic COVID-19.

All patients who did not have had an operation date before the pandemic COVID-19.

All patients who have been operating on during the month before the pandemic COVID-19.

Exclusion Criteria:

N/A
A Study in Healthy Men to Test How BI 690517 is Taken up and Handled by the Body

The trial is intended to investigate the basic pharmacokinetics, excretion pathways and metabolism of BI 690517 and its metabolites.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests.
* Age of 18 to 55 years (inclusive).
* Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive).
* Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.

Exclusion Criteria:

Subjects will not be allowed to participate, if any of the following general criteria apply:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator.
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 45 to 90 mmHg, or pulse rate outside the range of 40 to 100 beats per minute (bpm).
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance.
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator.
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair).
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders.
* History of relevant orthostatic hypotension (including but not limited to a reduction in systolic BP of ≥20 mm Hg or in diastolic BP of ≥10 mm Hg within 3 minutes of standing during screening measurement associated with clinical symptoms), fainting spells, or blackouts.

Further exclusion criteria apply.