cyrilzakka/clinical-trials huggingface dataset:
Supplemental Effects of ELDOA in Addition to Thoracic Manipulation on Upper Back Pain, Thoracic Kyphosis and Forward Head Posture in Thoracic Hypomobility

The purpose of this study is to determine the supplemental effects of ELDOA in addition to thoracic manipulation on upper back pain, thoracic kyphosis and forward head posture in thoracic hypomobility.


Eligibility Criteria:
Inclusion Criteria:

* Both male and females
* Adults (19-44 years)
* Upper back pain or discomfort
* Forward head posture
* Thoracic hypomobility
* Thoracic hyperkyphosis

Exclusion Criteria:

* Ankylosing spondylitis
* History of Spinal Fusion or spinal surgery (discectomy/laminectomy etc.)
* Degenerative disc disorders, Facet joint syndrome
* Cervical radiculopathy, Scoliosis
* Spinal Stenosis or Myelopathy
* Recent fracture or surgery
* TB of spine, Spondylolisthesis
* Not able to attend regular therapy appointments
* Fibromyalgia/myofascial pain syndrome
Observational Study of Disease Severity in Participants Diagnosed With Crohn's Disease and Long Term Impact of Treatment Strategies in Participants With Moderate to Severe Crohn's Disease (Protocol P06484)

This is an observational study to determine the prevalence of moderate to severe Crohn's disease (CD) among patients with active CD and to evaluate existing therapeutic trends in a standard clinical practice.


Eligibility Criteria:
Inclusion Criteria

1. Must have a diagnosis of active Crohn's Disease irrespective of severity,
2. Must be inadequately controlled with their current therapy and for whom physician

   decides to switch treatment.
3. Must be between 18 and 65 years of age, of either sex,
4. Must demonstrate willingness to participate in the study by signing the written informed consent.

Exclusion Criteria

* No specific exclusion criteria will be applied to a participant as long as the participant is eligible for the trial
Effectiveness of Respiratory Muscle Training with a Mobile Application After Lobectomy

It has been observed that there are negative effects on respiratory muscle strength following lobectomy. This has led to the necessity of respiratory muscle training to mitigate these adverse effects. Most studies conducted so far focus on the late postoperative period, and there are only a few studies evaluating the effectiveness of early postoperative inspiratory muscle training (IMT). It is believed that this method could be useful for facilitating patient follow-up and increasing patient motivation through visual feedback.

It has been observed that there are negative effects on respiratory muscle strength following lobectomy. This has led to the necessity of respiratory muscle training to mitigate these adverse effects. Most studies conducted so far focus on the late postoperative period, and there are only a few studies evaluating the effectiveness of early postoperative inspiratory muscle training (IMT). Additionally, there is currently no study assessing the effectiveness of IMT using a smart adapter in patients who have undergone lobectomy. It is believed that this method could be useful for facilitating patient follow-up and increasing patient motivation through visual feedback. The aim of this study is to examine the changes in respiratory muscle strength and exercise capacity in patients after lobectomy via VATS, comparing classical IMT, mobile application-supported IMT, and a control group that does not receive IMT.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study,
* Being clinically stable,
* Being a lung cancer patient with a planned lobectomy with VATS,
* Being between the ages of 18-65,
* Being able to cooperate with the tests to be performed.

Exclusion criteria:

* Having any orthopedic or neurological problem that prevents walking,
* Having undergone any surgery related to the thoracic wall,
* Having diseases that will affect respiratory parameters such as severe heart failure, severe chronic obstructive pulmonary disease (COPD).
Effectiveness of 'Nexpowder' for Hemostatic Treatments of Nonvariceal, Upper Gastrointestinal Bleeding

A prospective, multi-center, randomized controlled trial to evaluate safety and effectiveness of endoscopic hemostatic powder, 'Nexpowder' for hemostatic treatments of nonvariceal upper gastrointestinal bleeding.

This study is a prospective, multi-center, single blind (for patients), controlled investigation planned to evaluate safety and effectiveness of Nexpowder with 352 subject patients.

This investigational study is designed to compare effectiveness of using the standard-of-care hemostatic therapy only, versus the standard-of-care hemostatic therapy plus an additional hemostatic treatment using Nexpower for patients with nonvariceal, upper gastrointestinal bleeding from ulcers with high-risk stigmata (Forrest classification Ia, Ib, or IIa).

The primary end-points will be evaluated by assessing the rates of re-bleeding, which occur over three (3) days following initial hemostasis achieved with the standard-of-care hemostatic therapy.

Secondary end-points consist of evaluating three items: 1) Ease of use of Nexpowder applied for the test group after reaching initial hemostasis, 2) Nexpowder device malfunction and 3) safety follow-up to check occurrence of adverse event(s)/re-bleeding at 30-day (+5) time point.

Only the subjects whose initial hemostasis has been achieved will be registered for this investigation but those who initial hemostasis has failed to be reached with the standard-of-care therapie(s) shall not be registered for this investigation.

Eligibility Criteria:
Inclusion Criteria:

* Adult male or female with age of older than 19 years.
* Patients showing non-variceal upper GI bleeding symptoms
* An endoscopic examination indicates that the patients's ulcer is categorized Class Ia, Ib, or IIa according to the Forrest Classifications.

Exclusion Criteria:

* Pregnant or breast-feeding patients
Effectiveness of Radial Extracorporeal Shockwave Therapy in Patients With Chronic Low Back Pain

Analysis of the effectiveness of radial shock wave therapy as part of a multimodal pain therapy in the inpatient setting. Different therapy protocols are compared in previously non-operated and in previously operated patients.

Radial shock wave therapy is an approved pain therapy procedure that has been used in various degenerative orthopedic diseases for years. There are a few studies on the subject of chronic back pain. Some studies suggest that this method can be used sensibly. A direct comparison of different therapy protocols has not been carried out so far.

As part of inpatient multimodal pain therapy (including infiltration and physiotherapy) in patients with chronic lumbar back pain with or without degenerative surgery in the area of the lumbar spine radial shock wave therapy after a specific protocol is used. Only inpatients will be admitted to the study. All patients are informed verbally and give their written consent. Comprehensive patient information will be provided before the start of the study, handed out and explained as part of the information discussion. There will be 2 groups ((a) patients with previous degenerative surgery in the area of the lumbar spine, (b) patients without such a pre-operation) examined each with 4 sub-groups depending of the different therapy protocols.

Eligibility Criteria:
Inclusion Criteria:

* chronic lumbar back pain of min 3 months duration

Exclusion Criteria:

* radicular pain of higher intensity than chronic low back pain (cLBP)
* new neurologic deficits
* anticoagulant therapy
* new trauma to the lumbar spine
* spine bacterial infection
* spine tumor
* pregnancy
* coagulation disorder
* previous infiltration to the lumbar spine within 6 weeks prior to study inclusion
* fibromyalgia
Corneal Changes in Estrogen-Dependent Breast Cancer After Hormonal Treatment

Aromatase inhibitors (AI) therapy is the treatment of choice for estrogen receptor-positive breast cancer (BC). While AIs effectively suppress tumor growth, estrogen deprivation may have negative impacts on the eyes. This work evaluated the anterior segment changes in estrogen-dependent BC after hormonal treatment.

Aromatase inhibitors (AI) therapy is an important treatment for estrogen receptor-positive breast cancer (BC). This work evaluated the eye anterior segment changes in estrogen-dependent BC after hormonal treatment.

This cross-sectional study was conducted on female patients aged ≥18 who received treatment for BC. Patients were evaluated by a number of tests to determine the effects on the cornea and the lacrimal system

Eligibility Criteria:
Inclusion Criteria:

* Females diagnosed with breast cancer

Exclusion Criteria:

* uncontrolled diabetes , auto immune diseases
Application of Plant Protection Products (PPP) in Apple Orchards

The aim of the aPPPle pilot study is to test feasibility and generate first results in preparation for a main study. The aPPPle study will investigate the exposure of operators, workers and residents to plant protection products (PPP) and potential physiological effects on blood biomarkers. The target plants are apple crops, as application occurs at higher altitudes and therefore higher drift/exposure is expected compared to ground-level application. The substances to be investigated are acetamiprid (an insecticide) and dithianon and dodine (two fungicides).


Eligibility Criteria:
Inclusion Criteria:

* belonging to one of the defined study groups
* over 18 years of age at the time of recruitment
* person can understand the language and content of the study requirements
* person is capable of consenting to participate in the study and has given written consent to participate in the aPPPle study
* person has health insurance

Exclusion Criteria for residents and control:

person has direct professional contact with the tested substances acetamiprid, dithianon or dodine
The Search for Viral and Bacterial Etiology of Varicocele

This study is to answer the question is there any relationship between viral ( HSV 1 , HSV 2 , HPV 6/11, CMV, HHV 6 , HHV 8, BKV) or bacterial (Porphyromonas gingivalis, Treponema denticola, Tannerella forsythia, Fusobacterium nucleatum) infection and occurrence of varicocele in men.


Eligibility Criteria:
Inclusion Criteria:

* in experimental arm - varicocele grade II or III and infertility and/or pain

Exclusion Criteria:

* in control arm: presence of varicocele in ultrasound before surgery
Efficacy and Safety of Immunotherapy in Non-small Cell Lung Cancer With Uncommon Histological Type

This study was designed to explore the efficacy and safety of immune checkpoint inhibitor for advanced uncommon pathological types of lung cancer whether or not it is accompanied by a driver mutationin the real world. Through retrospective collection of clinical data of patients with uncommon pathological types of lung cancer.The patients who are treated with immunosuppressive agents are screened out, and they are divided into immune combination therapy or immune monotherapy, and further evaluate whether there is a difference in efficacy between the two.

This is a research project involving patients in Medical Oncology Department of Affiliated Cancer Hospital of Xiangya School of Medicine Central South University. Retrospective study of 40 patients with advanced uncommon pathological types of lung cancer and observe the efficacy and safety of immune checkpoint inhibitor regimen in the real world. The patients who are treated with immunosuppressive agents are screened out, and they are divided into immune combination therapy or immune monotherapy, and further evaluate whether there is a difference in efficacy between the two. Statistical analysis is used to compare the differences between the two treatments, so that patients can better choose treatment strategies.

Eligibility Criteria:
Inclusion Criteria:

* 18，Advanced uncommon pathological types of lung cancer by histopathology whether or not it is accompanied by a driver mutation Treatment Plan is pembrolizumab 200mg iv q21d

Exclusion Criteria:

- Patients received antitumor treatment before Patients with contraindication of chemotherapy Pregnant or breast feeding women
Myocardial Flow Reserve and 99mTc-DTPA Cardiac Dynamic SPECT

New CZT-based SPECT cameras are potentially capable of dynamic 3-D acquisition. Preliminary results suggested that dynamic acquisitions could allow the assessment of myocardial flow reserve using 99mTc-labelled perfusion tracers. The Flow-Heart study will assess the feasibility of myocardial flow reserve measurement by means of 99mTc-DTPA dynamic cardiac SPECT in 20 patients.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Patient clinically stable with known or suspected coronary disease
* Patient referred to Caen University Hospital for a myocardial perfusion SPECT
* Patient who accept to undergo subsequent additional cardiac dynamic SPECT using 99mTc-DTPA at rest and during pharmacological stress
* Informed consent dated and signed
* Affiliation to a social security system

Exclusion Criteria:

* Contraindication to dipyridamole (asthma, chronic obstructive pulmonary disease , pulmonary hypertension)
* History of poor tolerance of dipyridamole injection
* Cardiac arrhythmia (atrial fibrillation or frequent premature ventricular complex)
* Left bundle branch block, cardiac pacemaker, or implantable automatic defibrillator
* Recent history of myocardial infarction or unstable angina
* Pregnancy or lactating women
* Known obstructive renal or urinary disease
* Age under 18 years or guardianship
* Patient with an acute coronary syndrome or a coronary revascularization occurring between the conventional perfusion SPECT and the subsequent 99mTc-DTPA dynamic SPECT
iStent Inject in OAG Subjects on 2 Pre-op Topical Ocular Hypotensive Medications

The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of iStent inject in eyes of subjects with primary open-angle glaucoma previously on two anti-glaucoma medications.

The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of iStent inject in eyes of subjects with primary open-angle glaucoma previously on two anti-glaucoma medications. Outcomes will be evaluated at 12 and 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with primary open angle glaucoma (POAG)
* Subject on two ocular hypotensive medications

Exclusion Criteria:

* Traumatic, uveitic, neovascular, or angle closure glaucoma
* Fellow eye already enrolled
Pilot Study Investigating the Use of the ReBuilder to Treat Chemotherapy Induced Peripheral Neuropathy in Patients With Breast Cancer

The purpose of this study is to investigate the effect of the ReBuilder in the treatment of individuals with breast cancer and chemotherapy induced peripheral neuropathy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with breast cancer referred to Physical Therapy for CIPN
* Physical Therapy Examination indicates use of Rebuilder for CIPN
* At least 18 years of age
* Signed informed consent for study population
* Willingness to complete study according to protocol

Exclusion Criteria:

* Patients who do not have CIPN
* Patients \<18 years of age
* Inability to or unwilling to sign informed consent
* Unable to read and understand the English language
* Preexisting sensory peripheral neuropathy from other comorbid conditions such as diabetes or alcoholism
* More than three (3) prior ReBuilder treatments; OR ReBuilder within the last 30 days, for sensory peripheral neuropathy
Influence of Variations in Systemic Blood Flow and Blood Pressure on Cerebral Oxygenation Measured by Cerebral Oximetry

This study emphasizes on the influence of changes in systemic flow and systemic mean arterial blood pressure (MAP) during cardiopulmonary bypass (CPB) on cerebral oxygenation assessed by near-infrared spectroscopy (NIRS). The aim of the study is to determine whether variations in systemic flow, in MAP, or in both variables at the same time have the greatest impact on the cerebral oxygen saturation.

Cerebral autoregulation is defined as the whole of regulatory mechanisms that maintains a constant cerebral blood flow (CBF) during changes in cerebral perfusion pressure (CPP). Cerebrovascular resistance adjusts when CPP changes in order to keep CBF constant. In contrast with this concept of pressure-mediated autoregulation, it is suggested that cerebral autoregulation is focused on maintaining homeostasis of the cerebral metabolic rate of oxygen (CMRO2). We assume that both flow and pressure contribute to the regulation of CMRO2.

Assessment of cerebral oxygenation - Cerebral oxygen saturation will be monitored with near-infrared spectroscopy (NIRS). NIRS allows simple, continuous and non-invasive measurement of cerebral oxygen saturation (ScO2)and primarily cerebral venous saturation. Cerebral oxygen saturation will be monitored with a FDA-approved devices: INVOS 5100 (Somanetics Corporation, Troy, MI, USA).

To study the effects of changes in pressure and in flow, we need a condition where we can alter these variables separately and in a controlled manner. Therefore this study will be performed during cardiopulmonary bypass (CPB). Pressure will be varied with the administration of routinely used vasoactive substances, while flow will be varied by altering the pump flow manually. We hypothesize that if we change one parameter (pressure or flow), a compensatory mechanism will preserve the CMRO2 homeostasis, with no change in ScO2. On the other hand, if we change both pressure and flow, we expect a significant effect on cerebral oxygen saturation. With 20 % changes in pressure and/or flow, we expect a change in NIRS values of approximately 5 %. Previous studies showed that this kind of reduction is well tolerated by the brain. This means that the proposed changes are within the normal physiological range, and will have no adverse effects.

Eligibility Criteria:
Inclusion Criteria:

* Age 21-100 years, scheduled for elective cardiac surgery, written informed consent.

Exclusion Criteria:

* History of cerebrovascular disease or symptomatic carotid artery stenosis.
Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Incidence in Patients With Central Versus Peripheral Embolism

Chronic thromboembolic pulmonary hypertension (CTEPH) has been associated with increased morbidity and mortality. Patients with pulmonary embolism (PE) have elevated risk for development of CTEPH. It is not known, whether the location of pulmonary embolism (central vs. peripheral) nor fibrinolysis have an impact of CTEPH incidence. This study has been performed to assess the CTEPH incidence in different populations: in patients with central vs. peripheral PE and in patients with or without fibrinolysis therapy for PE.

The embolus localization during index pulmonary embolism might be of potential relevance for CTEPH development.

In the present study patients with confirmed pulmonary embolism for at least 12 months will be screened for CTEPH. The incidence of CTEPH will be correlated to thrombus location (central vs. peripheral) and the index use of fibrinolysis.

Eligibility Criteria:
Inclusion Criteria:

* acute pulmonary embolism for at least 12 months

Exclusion Criteria:

* known pulmonary hypertension other than CTEPH
fMRI to Examine the Effect of CBTm to Increase Resiliency for PTSD

A substantial proportion of public safety personnel (PSP) develop service-related posttraumatic stress disorder (PTSD). PTSD is associated with a range of negative outcomes and its exact underlying neurophysiological mechanism is still not well understood. Cognitive behavioral therapy (CBT) is commonly prescribed to treat PTSD, and recent studies suggest that it may be effective in preventing the condition. We have developed a 5-session class focused on teaching introductory CBT skills to prevent and manage psychological distress, and we are currently in the process of launching a clinical trial to demonstrate its effectiveness in preventing PTSD and related conditions in PSP. In the proposed adjunctive study to this trial, we will quantitate the brain connectivity signature that is specific to the PTSD-resilience, and examine whether the classes increase this resilience-related brain mechanism.

Our ultimate research goal is to develop and validate a preventive strategy for PTSD. We aim to 1) demonstrate neurophysiological evidence (using fMRI) of preventive CBTm classes for PTSD, and 2) validate the utility of the proposed imaging-based biomarker for PTSD-related resiliency. Emerging evidence suggests that a program such as CBTm classes could promote resiliency to PTSD in healthy individuals at high risk for trauma exposure. Further, our preliminary brain imaging data analysis suggests that we can quantitate the brain connectivity pattern that may reflect resilience to PTSD. We thus hypothesize that CBTm will increase the PTSD resilience-related brain connectivity pattern expression.

In this novel pilot imaging study, we will recruit 40 PSP without PTSD or other mental disorder from 120 participants participating in our larger clinical trial. Twenty will be from each arm (CBTm and wait-list). The effect of CBTm on fMRI-based measures will be compared between arms.

Eligibility Criteria:
Inclusion Criteria:

* Must be enrolled in our on-going parallel study - "Cognitive Behaviour Therapy with Mindfulness Course for Building Workplace Resilience: A Pilot Randomized Controlled Trial"

Exclusion Criteria:

* if they have received psychological or medication treatment for a mental disorder in the past 6 months or if they score above the clinical cutoff on the following self-report symptom measures: Posttraumatic Checklist-5 (PCL-5) score \>37; Patient Health Questionnaire-9 (PHQ-9) score (depression) \>10, Generalized Anxiety Disorder-7 (GAD-7) score \>7, and the presence of suicidal ideation in the past six months. Individuals falling below these cutoff scores will receive further diagnostic assessment by a supervised PhD graduate student in Clinical Psychology. Those meeting criteria for PTSD or other mental disorder in the past 12 months as assessed by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) or the Mini International Neuropsychiatric Interview (MINI v.7.0.2) will also be excluded. Finally, we will exclude individuals with any contraindication to MRI (e.g., claustrophobia and metal implants).
Safety and Effectiveness of NicVAX in Treating Nicotine Dependent Individuals

Nicotine is highly addictive and many individuals are unable to quit smoking even with treatment. The purpose of this study is to determine the effectiveness of various doses of NicVAX in treating nicotine dependent individuals.

Tobacco use is the single leading preventable cause of death in the United States. Nicotine is an alkaloid that is derived from the tobacco plant responsible for the psychoactive and addictive effects of smoking. Immunotherapy may be useful in preventing and treating nicotine dependent individuals. NicVAX is a nicotine vaccine, a type of immunotherapy that may be effective in smoking cessation and preventing relapse to nicotine. The purpose of this study is to evaluate the safety and efficacy of various dosing levels and dosing frequencies of NicVAX in treating nicotine dependent individuals.

Eligibility Criteria:
Inclusion Criteria:

* Current smoker
* Good general health, including mental health
* Alveolar carbon monoxide level greater than or equal to 10 ppm

Exclusion Criteria:

* Prior exposure to NicVAX
* Known allergy to any of the components of NicVAX
* Use of any smoking cessation aide
* Pregnant or breastfeeding