cyrilzakka/clinical-trials huggingface dataset:
Sex Difference in Preemptive Analgesic Effects With Flurbiprofen Axetil on Postoperative Pain and Sleep Quality

In humans and animals, circadian rhythm sleep cycle plays an important role on maintaining and regulating basic physiological homeostasis, such as cognitive function, glucose metabolism, memory consolidation, immune function and growth hormone secretion. The induction of general anesthesia leads to a state of reduced responsiveness, which is often described by anesthesiologists and patients as "sleep". This seems to be a common problem in the case of patients under general anesthesia, besides surgery trauma and general anesthetics may change sleep function and sleep cycle perioperatively, the postoperative complications such as pain, nausea and vomiting etc after general anesthesia may also reduce postoperative sleep quality.Flurbiprofen axetil is a new non-steroidal anti infection analgesic(NSAIDs), which is widely used for analgesia to reduce the dose of opioids and the occurrence of adverse reactions, such as declined sleep quality, respiratory depression, nausea and vomiting . Preemptive analgesia is an analgesic intervention that begins before surgery to prevent the nervous system from becoming sensitive to subsequent stimuli that may aggravate pain. A large number of experimental studies have shown that use flurbiprofen axetil preoperatively is better than use it postoperatively. However, limited information was reported before on the effect of factors such as age, gender, preoperative negative mood such as anxiety and depression, type and length of surgery, which could influence postoperative pain and analgesic consumption and the association between postoperative sleep quality and postoperative pain intensity. At present, there has been less previous evidence for how preemptive analgesic with flurbiprofen axetil affect postoperative sleep quality through its effect on postoperative pain of patients with different sex under general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

1. age between 18 and 80 years;
2. American Society of Anaesthesiologists (ASA) physical status I-Ⅲ.

Exclusion Criteria:

1. patients with central nervous system and mental illness;
2. patients with preoperative sleep disorders;
3. patients with a history of sedation, analgesia or antidepressants;
4. patients with sleep apnea or obstructive sleep apnea hypopnea syndrome;
5. patients with chronic gastritis and gastric ulcer
6. patients who are allergic to flurbiprofen axetil.
Immediate Effect of Ankle Mobilization on Active Range of Motion and Gait in Subacute Stroke

The goal of this observational study is to determine the effect of ankle joint mobilization on active range of motion and gait in subacute first-time stroke. The main questions it aims to answer are:

* What is the effect of ankle joint mobilization on active range of motion in the ankle and gait qualities?
* What is the effect of ankle joint mobilization on self-perceived gait ability?

Participants will receive physical therapy interventions of:

* Grade III ankle joint mobilization
* stretching of ankle plantarflexor muscles
* ankle muscle activation training
* assisted gait as part of assessment

Study design is to measure conditions before and after the intervention to determine effect(s) of one treatment dose, completed within one session of 90 minutes.

Initial passive and active ankle range of motion measured by goniometer. Initial gait quality will be measured by walking with splinting for frontal plane ankle stability if indicated, assistive device for body weight support if needed, and manual assistance from an experienced physical therapist, on a Zeno Walkway pressure-sensitive mat for five complete stride cycles, taking 3 to 5 minutes. Data collected from the mat will be electronically captured using ProtoKinetics software. Participant initial self-rated perception of ability to walk will be marked on a 0-10 scale, on paper. Treatment intervention follows. With participant lying on the back, paretic ankle moderate-force grade III anterior to posterior-directed manual joint mobilizations will be performed by therapist; three sets of fifteen oscillations. Ankle plantarflexor muscles will be stretched for 75 seconds in supported standing. Ankle dorsiflexion muscle activation training will be performed for three minutes while in a seated position. Post-intervention measurements will proceed in the same sequence as initial measurements listed above: Ankle passive and active range of motion and walking ability will be reassessed, and self-perceived ability to walk will be rated again.

Eligibility Criteria:
Inclusion Criteria:

* First stroke
* subacute phase after stroke
* able to follow one-step commands
* paretic passive ankle dorsiflexion less than 5 degrees

Exclusion Criteria: referring to paretic ankle;

* ankle pain of undetermined cause at rest
* fracture in paretic lower extremity
* muscle or ligament tear
* recent ankle sprain
* skin tear or wound
* joint fusion or implanted hardware
Development of Software to Provide the SpeechVive Device Via the Internet

Telehealth, increasingly recognized in the neurology field as a solution to access issues for people with Parkinson's disease, improves access to speech therapy, particularly those living in rural areas or with travel barriers. The SpeechVive device, developed by SpeechVive, Inc., is a treatment solution that is easy to use and effective. In an NIH funded study, the SpeechVive device improved communication in 90% of individuals with PD by improving volume, articulation, and speech rate. The investigators propose to eliminate the one drawback of the SpeechVive device, namely that it currently must be programmed by a speech-language pathologist for each patient in person. The overall goal of this project is to develop a telehealth platform for the SpeechVive device that will enable video conferencing for treatment and remote programming of the SpeechVive device for each patient. Once the platform has been developed, the investigators will conduct a study to examine effectiveness and the patient and caregiver satisfaction with telepractice using the SpeechVive device.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinson's disease
* Difficulty communicating
* Is currently being seen, or agrees to be seen, by a speech pathologist who fits the SpeechVive device and also has agreed to participate in the study
* Has a regular caregiver living with him/her

Exclusion Criteria:

* Neurological diagnoses (except Parkinson's disease)
* Bilateral hearing aids (since one free ear is required for use of the SpeechVive device)
A Study to Assess Efficacy and Safety of GLPG1972/S201086 in Participants With Knee Osteoarthritis

This study is a phase 2, 52-week international, multi-regional, multi-center, randomized, double-blind, placebo-controlled dose-ranging study for the treatment of osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Male participants or female participants of non-childbearing potential and not breastfeeding.
* Body weight \> 40 kg, body mass index (BMI) \< 40 kg/m\^2.
* Diagnosed for knee osteoarthritis based on clinical and radiological criteria of the American College of Rheumatology.
* History of knee pain for at least 6 months and on the majority of days (\> 50%) during the preceding month.
* Symptom severity defined by a pain ≥ 40 mm and ≤ 90 mm on visual analogue scale (VAS, 100 mm) at screening and inclusion visits.
* Documented need for symptomatic as needed-treatment for osteoarthritis (OA) in the target knee with systemic non-steroidal anti-inflammatory drugs (NSAIDs) and/or other analgesics

Exclusion Criteria:

* Severe clinical knee malalignment according to the investigator.
* Knee prosthesis already implanted (\< 1 year) or not well-tolerated (contralateral side).
* Knee prosthesis already foreseen within the study period (whichever side).
* Hip prosthesis recently implanted (\< 1 year) or foreseen within the study period (whichever side).
* Previous osteotomy on the inferior limbs (whichever side).
* Surgical operation on the target knee within the 12 months prior to the screening visit or planned during the study.
* Diagnostic arthroscopy of the target knee within the 6 months prior to the screening visit or planned during the study.
* Other pathologies affecting the target knee.
* Any contraindication to magnetic resonance imaging (MRI) including the inability to undergo a knee MRI exam because of inability to fit in the scanner or knee coil.
PRESERVE-MITRAL Post-Market Registry

The objective of this registry is to gather data on the clinical outcomes of Medtronic mitral repair products (Profile 3D™ and CG Future® annuloplasty systems) in the approved intended use up to 12 months from the day of procedure

There is limited local evidence on mitral repair products in South Asia and a prospective post market registry will provide real world data on clinical outcomes.

Patients suffering from mitral valve disease and indicated for a mitral valve repair procedure with Profile 3D™ and CG Future® annuloplasty system as part of standard of care, in accordance with the product label indications (instructions for use), contraindications, and warnings will be considered for study participation.

PRESERVE-Mitral Registry is a prospective non-randomized, non-interventional, post-market registry

The objective of this registry is to gather data on the clinical outcomes of Medtronic mitral repair products (Profile 3D™ and CG Future® annuloplasty systems) in the approved intended use up to 12 months from the day of procedure

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trail was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Heath Service Act or 42 CRF 11.24 and 11.44.)

Eligibility Criteria:
Inclusion Criteria:

1. Patients with valvular insufficiency and/or stenosis and indicated for the reconstruction and/or remodeling of pathological mitral valves with Profile 3D™ and CG Future® annuloplasty systems
2. Indications and contraindications provided in the product Instructions for Use
3. Subject is 18 years of age or older
4. The patient or his/her Legally Authorized Representative (LAR) has been informed about the nature of the registry and the patient informed consent for study participation has been obtained prior to performing any study-related procedures from the subject or Legally Authorized Representative, as per applicable local requirements

Exclusion Criteria:

1. Contraindications as per instructions-for-use (IFU):

   1. Heavily calcified valves
   2. Valvular retraction with severely reduced mobility
   3. Active bacterial endocarditis
2. Aortic valve replacement as concomitant procedure
3. Already participating in another clinical study, possibly leading to bias and jeopardizing the scientific appropriate assessment of the study endpoints
Testing Spectrosense EVA System for Detection of Pancreatic Cancer by Analyzing Volatile Organic Compounds (VOCs) in Exhaled Air

Volatile Organic Compounds (VOC) in human breath are captured and analyzed by the Spectrosense EVA system, which is combination of a gas chromatography (GC) and software algorithm. The objective is to obtain a set or sets of VOC bio-markers that will provide the best discrimination between Pancreatic Cancer sick population and healthy population. The gold standard for identifying sick/healthy population is biopsy proven Pancreatic cancer.


Eligibility Criteria:
Pancreatic cancer Group

Inclusion Criteria:

* Age from 18 years old
* Pancreatic cancer positive biopsy
* Before any treatment
* Signed Informed Patient Consent

Exclusion Criteria:

* Age under 18 years old
* Neoadjovant treatment
* Post surgery for Pancreatic cancer
* A history of any other cancer type, except skin cancer that is not melanoma

Healthy Group

Inclusion Criteria:

* Healthy patients
* No history of Pancreatic cancer
* Signed Informed Patient Consent

Exclusion Criteria:

* History of Pancreatic cancer
* Pancreatic cancer background in the family
* A history of any other cancer type, except skin cancer that is not melanoma
Acamprosate Safe to Use in Individuals With Liver Disease.

Is acamprosate safe to use in individuals with liver disease.

Adult patients aged 21 or over with a diagnosis of alcohol-related liver disease and alcohol use disorder (AUD) and abstinent from alcohol for at least 2 weeks (but not more than 6 months) prior to initiating acamprosate treatment.

Eligibility Criteria:
Inclusion criteria:

* Aged 21 or over
* Diagnosis of alcohol-related liver disease and AUD.

  * The diagnosis of alcohol-related liver disease will be determined by a hepatologist based on history of regular and excessive alcohol consumption in the absence of other causes of liver cirrhosis or acute hepatitis, compatible clinical, imaging and laboratory findings and typical histology on liver biopsy, if performed. Underlying liver disease may include alcoholic hepatitis, advanced (F3-F4) fibrosis, and/or portal hypertension.
  * The diagnosis of AUD will be determined by a hepatologist and/or addiction psychiatrist based on history obtained that is consistent with DSM-5 diagnostic criteria for AUD (all categories of mild, moderate and severe considered eligible) (American Psychiatric Association, 2013; questions from NIH, 2016).
* Abstinent from alcohol for at least 2 weeks (but not more than 6 months) prior to initiating acamprosate treatment.
* At study enrollment, initial MELD-Na score must be less than 20 for the five individuals enrolling in the first phase of the pilot safety assessment. The second phase of the pilot safety assessment will include individuals with a MELD-Na of 20 or more at enrollment.
* Have capacity to provide consent themselves

Exclusion criteria:

* Individuals with a glomerular filtration rate (GFR) of less than 30 ml/min
* Congestive heart failure (NYHA class II or higher)
* Hypotension, requiring the use of vasoconstrictors (i.e. midodrine)
* Pregnancy, lactation or refusal to use a reliable method of birth control if a sexually active female of childbearing potential. Although no human trial data is available, animal studies suggest possible teratogenic effects of acamprosate (Merck, 2005).
Adult Congenital Heart Disease International EValuation of the Effectiveness of SGLT2i Registry

This real-world, international registry aims to evaluate the current experience with sodium-glucose cotransporter 2 inhibitors (SGLT2i) in adult congenital heart disease (ACHD) patients by investigating the prescription patterns, safety, tolerability, and potential beneficial effects on heart failure-related outcomes.

In the adult congenital heart disease (ACHD) population, heart failure currently represents the main cause of morbidity and mortality. The etiology of ACHD-related heart failure is heterogenous, and there is limited evidence for pharmacological treatment options for this population.

Sodium-glucose cotransporter 2 inhibitors (SGLT2i) are a novel pillar in the treatment of conventional LV heart failure. SGLT2i have been shown to reduce the risk of worsening heart failure and cardiovascular-related death in patients with LV heart failure.

While the exact mechanisms of action are still to be elucidated, SGLT2i seem to address heart failure by targeting several pathways. These include but are not limited to; a decrease in renin-angiotensin and sympathetic nervous system activation, a decrease in pressure overload-induced myocardial fibrosis, reverse cardiac remodeling, and improvement in myocardial energetics.

Given the compelling evidence on the effectiveness of SGLT2i over a broad range of cardiac dysfunction and initial promising reports of its utilization in the field of ACHD, SGLT2i deserve further exploration in the group of ACHD patients.

This real-world, international registry aims to evaluate the current experience with SGLT2i in ACHD patients by investigating the prescription patterns, safety, tolerability, and potential beneficial effects on heart failure-related outcomes.

Project design:

Data of all ACHD patients who were started on an SGLT2i will be collected in a real-world, international registry. Only data resulting from routine clinical care will be collected from the electronic health records at the participating centers, and participants will not undergo any interventions for this project. Data will be collected from 1 year before starting with the SGLT2i to most recent follow-up after starting with the SGLT2i, to evaluate if SGLT2i therapy halts the progression of clinical deterioration in ACHD patients with heart failure and can improve heart failure-related outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Congenital heart defect.
* Age ≥ 18 years.
* Initiated on treatment with an SGLT2i.

Exclusion Criteria:

- No consent for data collection.
Zoledronic Acid for the Prevention of TDF-sparing ART-induced Bone Mass Density Loss in Treatment-naive HIV Positive Individuals

The goal of this clinical trial is to learn if zolendric acid can prevent the anticipated deterioration of bone mass after antiviral treatment initiation for people that were recently diagnosed with HIV.

The main questions it aims to answer are:

1. Is bone mass deterioration is significant even with the new medication currently used to treat HIV?
2. Can one dose of Zolendric acid protect from deterioration of bone mass.

Researchers will compare one dose of zolendric acid to follow-up only

Participant will:

1. Provide blood samples for bone markers before antiviral treatment initiation and at 6M,12M,24M and 48M after treatment initiation
2. Perform DXA scan soon after antiviral treatment initiation and after 12M ,24 M and 48 months
3. Half of the patients with moderate reduction in bone mass will be treated with one dose of zolendric acid in the clinical trial, the other participants will be followed without intervention.
4. Patients with substantial osteoporosis will be treated according to standard of care by their HMO, but will continue followup in the study.


Eligibility Criteria:
Inclusion Criteria:

* Adults over age of 18 years old of any gender, social, religious or racial background.
* Confirmed positive result for HIV infection.

Exclusion Criteria:

Patients who received previous pharmacological agents for the prevention of HIV infection.

* Women who are pregnant, lactating or those who plan to become pregnant within the trial timeframe.
* Past history of severe drug-induced reaction (including atypical femur fractures or osteonecrosis of the jaw) or documented hypersensitivity to a bisphosphanate agent.
* Patients with untreated hypocalcemia at screening.
* Severe dental status
The Relationship of Orthodontic Malocclusions With Temporomandibular Joint Disorders

The patients who applied to the hospital for orthodontic treatment were asked various questions to evaluate their oral health related quality of life, malocclusions and self reported temporomandibular joint problems.

The patients who applied to the hospital for orthodontic treatment were asked various questions to evaluate their oral health related quality of life, malocclusions and self reported temporomandibular joint problems. For this purposes Oral Health Impact Profile-14, and Helkimo's indexes were used.The relationship between these results were investigated.

Eligibility Criteria:
Inclusion Criteria:

* wish to receive orthodontic treatment in our clinic.

Exclusion Criteria:

* The absence of willingness for the temporomandibular joint and clinical examination or answering the survey questions.
Replication of the ISAR-REACT 5 Antiplatelet Trial in Healthcare Claims Data

Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates through standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.

Eligibility Criteria:
Criteria:

Please see https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions.

Inclusion Criteria:

* Hospitalization for unstable angina or acute MI AND age \>= 18 years Days \[ACS admission\]
* STEMI OR NSTEMI/unstable angina (during admission) + 1 of the following

  * \>= 60 years old Days \[ACS\]
  * \>= 3 risk factors for coronary artery disease
  * Diabetes mellitus
  * Chronic renal disease
  * Carotid stenosis \>= 50% or cerebral revascularization
  * Peripheral artery disease Days \[-365, ACS\]
  * Aspirin use
  * Angina Days \[-7, ACS\]
  * Prior MI or CABG any time prior

Exclusion Criteria:

* Acute complication PCI Days \[-30, ACS admission\]
* History of any stroke or TIA Days \[all available data, 0\]
* Intracranial neoplasm, intracranial AVM, intracranial neoplasm Days \[-180, 0\]
* Active bleeding Days \[-180, 0\]
* Platelet count \< 100.000/uL Days \[-180, 0\]
* Anemia (hemoglobin \< 10 g/dL) Days \[-180, 0\]
* Chronic renal insufficiency requiring dialysis Days \[-180, 0\]
* Moderate to severe hepatic dysfunction Days \[-180, 0\]
* Increased risk of bradycardia events Days \[-180, 0\]
* Life expectancy, 1 year Days \[-180, 0\]
* Pregnancy Days \[-180, 0\]
* Concomitant therapy CYP3A inhibitors, CYP3A substrates, or strong CYP3A inducers Days \[-14, 0\]