cyrilzakka/clinical-trials huggingface dataset:
Lumbar Plexus Block for Postoperative Pain Control After Hip Arthroscopy. A Randomized Controlled Trial

The purpose of this study is to determine whether the use of a lumbar plexus block for arthroscopic hip surgery is superior to oral and intravenous opioid pain medications alone in treating pain. In addition, the study will examine whether lumbar plexus blocks reduce the total amount of pain medication needed, and therefore reduce the side effects of these medicines and increase patient satisfaction. It is hypothesized that addition of the lumbar plexus block will significantly reduce patients' postoperative pain.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) Class 1-3
* Patients aged 18 to 65 years
* Patients scheduled for primary, unilateral arthroscopic hip surgery by Dr. Kelly, Dr. Coleman, or Dr. Anil Ranawat
* Planned use of neuraxial anesthesia
* Body Mass Index less than 35
* Ability to follow study protocol

Exclusion Criteria:

* Chronic opioid use (defined as daily or almost daily use of opioids for \>3 months)
* Contraindication to combined spinal-epidural anesthesia including but not limited to bleeding disorder, use of clinically relevant anticoagulant or antiplatelet medications, and anatomic abnormalities.
* Contraindication to lumbar plexus block including but not limited to bleeding disorder, use of clinically relevant anticoagulant or antiplatelet medications, and anatomic abnormalities.
* Infection at the injection site(s)
* Allergy to any of the study medications
* Contraindication to a short course of NSAIDs (renal failure, intolerance)
* ASA Class 4-5
* Patient refusal
* Patients younger than 18 years old and older than 65
* Patients with any known indwelling hardware of the lumbar spine.
* Patients with a peripheral neuropathy of the surgical extremity
* Non-English speaking patients
Safety and Effectiveness of the Yaari Extractor for Management of Shoulder Dystocia

Prospective, multi-center, single arm with historical control, to verify the safety and effectiveness of the Yaari Extractor used by board certified or board eligible U.S. OB/GYN physicians in the management of shoulder dystocia.


Eligibility Criteria:
Inclusion Criteria:

1. Subject 18 years of age or older at time of consent.
2. Subject planning on vaginal birth.
3. Singleton pregnancy in vertex presentation.
4. Full-term pregnancy having completed 37 weeks or more gestational weeks.
5. Able and willing to provide written informed consent prior to enrollment.
6. In the opinion of the Investigator, the subject has sufficient mental capacity to understand the informed consent form (ICF).
7. Subject with fetus experiencing shoulder dystocia as defined by ACOG Practice Bulletin 178 "Shoulder dystocia is most commonly diagnosed as failure to deliver the fetal shoulder(s) with gentle downward traction on the fetal head, requiring additional maneuvers to effect delivery."

Exclusion Criteria:

1. Patients who have undergone ancillary standard of care maneuvers, to include first-line maneuvers (McRoberts/suprapubic pressure), prior to use of the Yaari Extractor.
2. Cesarean section is planned for the patient.
3. Obstetric contraindications to vaginal birth.
4. Subject carrying fetus with known significant chromosomal or structural anomalies.
5. Clinically estimated fetal weight ≥5kg in non-diabetic subjects.
6. Clinically estimated fetal weight ≥4.5kg in subjects with diabetes.
7. Subject has any general health condition or systemic disease that may represent, in the opinion of the Investigator, a potential increased risk associated with device use or pregnancy.
8. Bleeding disorders, such as thrombocytopenia, von Willebrand's disease, bleeding disorder currently using anticoagulation medication, etc.
9. Any maternal disease or disorder that precludes the subject from pushing effectively.
10. If the maternal cervix is not fully dilated.
11. If the fetal head is not completely out of the birth canal.
12. In the presence of a non-reducible nuchal cord.
Inflammation and Clotting Abnormalities in Aneurysmal Coronary Artery Disease

The main objective of the CARE-ANEURYSM project is to evaluate inflammation and clotting abnormalities in patients with aneurysmal coronary artery disease in relation to patients with abdominal aortic aneurysm or coronary artery disease (acting as controls).

The trial will enrol 180 patients, 60 in each of three groups: 1) aneurysmal coronary artery disease; 2) abdominal aortic aneurysm; 3) coronary artery disease. In addition, up to 250 patients with aneurysmal coronary disease will be follow for clinical outcomes in relation to controls (prognosis group).

The primary research question of this project is to evaluate wheter the inflammation and clotting abnormalities in patients with aneurysmal coronary artery disease differ from ones in abdominal aortic aneurysm or coronary artery diseases. Study endpoints include the level of inflammation biomarkers and fibrin clot properties in each cohort.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-85 years old
* Angiographically confirmed coronary artery ectasia or aneurysm (Arm I)
* Abdominal aortic aneurysm (Arm II)
* Angiographically confirmed coronary artery disease (Arm III)

Exclusion Criteria:

* Less than 12 months from ACS
* Actual oral anticoagulant therapy
* Actual antiplatelet therapy other than aspirin
* Heart failure NYHA IV
* Untreated hyperthyroidism or hypothyroidism
* Severe comorbidities
* Lack of consent
Neurobiological Markers of Treatment Response for Anxiety and OCD

Obsessive-compulsive disorder (OCD) and anxiety disorders are common and debilitating conditions which are often chronic when treatment is not provided. International guidelines recommend cognitive behavioral therapy (CBT) as the first-line treatment, and research has shown that CBT can be delivered over a concentrated period of time. The Bergen 4-Day Treatment (B4DT) is an exposure-based treatment which is delivered over four consecutive days. B4DT has been shown to induce rapid and long-lasting remission in around 70% of patients. This provides a platform for studying psychological and neurobiological changes associated with treatment response and non-response. The present study will investigate longitudinal changes in psychological measures and DNA methylation in patients who receive the B4DT, as well as a subset will also undergo multimodal brain imaging.

The primary study will include 500 OCD patients who will receive the B4DT. Symptom severity will be prospectively measured before treatment, approximately 10 days after treatment and three months after treatment. Saliva samples will be collected for later extraction of DNA methylation during the first day of treatment, the last day of treatment, and three months after treatment. A substudy will use multimodal magnetic resonance imaging (MRI) before treatment, approximately 10 days after treatment and three months after treatment. The substudy will also 100 patients with social anxiety disorder or panic disorder for DNA methylation and MRI, as well as 50 healthy controls for MRI. Clinical data will be collected from a consent-based quality register ("Kvalitetsregister for konsentrerte behandlingsformat").

The aim of the study is to investigate changes in DNA methylation as well as functional and structural brain networks that occur in patients undergoing B4DT, and to correlate these changes with immediate and long-term response to treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with obsessive-compulsive disorder, panic disorder or social anxiety disorder using DSM-5 criteria
* Referred to National Clinic for 4-Day Treatment, Haukeland University Hospital, Bergen, Norway
* Consented to participate in the "Kvalitetsregister for konsentrerte behandlingsformat"

Exclusion Criteria:

* Suicidal, ongoing mania, primary eating disorder, intellectual disability, ongoing psychosis, ongoing substance abuse

For MRI substudy:

Inclusion Criteria:

- For the healthy controls, no previous or current psychiatric disorders as detected by the Mini International Neuropsychiatric Interview (MINI)

Exclusion Criteria:

- MRI incompatibility (e.g. pregnancy, metal implants)
Research of Endobronchial Optical Coherence Tomography in Pre-COPD

The pre-stage of Chronic Obstructive Pulmonary Disease (Pre-COPD) is challenging to diagnose. However, identifying Pre-COPD is a crucial step in the prevention and management of COPD. Endobronchial optical coherence tomography showed the value of diagnosis in Pre-COPD and COPD in previous researchs.

We recruited COPD patients (stage I-II, n=15; stage III-IV, n= 15), Pre-COPD (n= 20) and healthy never-smokers (healthy human, n=21). Age,gender,BMI, smoking history, spirometry, chest computed tomography (CT), bronchoscopy and EB-OCT were performed. Inner luminal area (Ai) and airway wall area (Aw) of bronchi which inner perimeter was 10mm, 20mm and 30mm were measured using EB-OCT respectively. By analyzing and studying the above situation, we aim to discover the application value of OCT in Pre-COPD

Eligibility Criteria:
Inclusion Criteria:

* non-smoking with normal lung function, no other pulmonary diseases besides pulmonary nodule as indicated by chest computed tomography (CT).

Exclusion Criteria:

* (1) patients with contraindication of bronchoscopy, (2) patients who are participating in other clinical studies, (3) patients with poor compliance who are believed by the researchers to be unable to cooperate for the completion of the examination and follow-up, and (4) women who were pregnant.
Evaluation of Efficacy and Safety of a Single Dose of Exa-cel in Participants With Severe Sickle Cell Disease, βS/βC Genotype

The purpose of the study is to evaluate the efficacy and safety of CTX001 (exa-cel) in adolescent and adult participants with severe sickle cell disease (SCD), βS/βC genotype (HbSC).


Eligibility Criteria:
Key Inclusion Criteria:

* Participants with documented βS/βC (HbSC) genotype
* Participants must be eligible for autologous stem cell transplant as per investigator's judgment

Key Exclusion Criteria:

* A willing and healthy 10/10 human leukocyte antigen (HLA)-matched related donor is available per investigator's judgement
* Participants with prior hematopoietic stem cell transplant (HSCT)
* Treatment with regular RBC transfusions that, in the opinion of the investigator, cannot be interrupted after engraftment.

Other protocol defined Inclusion/Exclusion criteria may apply.
Efficacy of CPAP Treatment on Blood Pressure of Resistant Hypertension Patients With Obstructive Sleep Apnea Syndrome

The aim is to evaluate the effect of treatment with Continuous Positive Airway Pressure (CPAP) device on clinic and ambulatory blood pressures (BP) of 200 resistant hypertensive patients with moderate-severe obstructive sleep apnea syndrome (OSAS).

Obstructive sleep apnea syndromes (OSAS) have been demonstrated to be highly prevalent in patients with resistant hypertension (defined as uncontrolled clinic BP despite being on anti-hypertensive treatment with at least 3 drugs in optimal doses and including a diuretic). Nevertheless, the effect of treating OSAS with Continuous Positive Airway Pressure (CPAP) device on clinic and ambulatory BPs in patients with resistant hypertension is largely unknown. Hence, the primary aim of this randomized clinical trial is to evaluate the effect of CPAP on BP levels in resistant hypertensive patients with moderate-severe OSAS (defined as an apnea-hypopnea index \[AHI\] greater than 15 on a full polysomnographic examination). Two-hundred patients will be randomly allocated either to treatment with CPAP device plus their usual anti-hypertensive treatment or to continue their usual treatment alone for 6 months. Clinic and 24-hour ambulatory BP monitoring, laboratory evaluation (including microalbuminuria and aldosterone-to-renin ratio), 24-hour Holter monitoring, ergospirometric treadmill test, and carotid-femoral pulse wave velocity measurement will be performed before and after the 6-month treatment, with the observers blinded to the allocation group.

Eligibility Criteria:
Inclusion Criteria:

* Patients with resistant hypertension and moderate-severe obstructive sleep apnea syndrome

Exclusion Criteria:

* Older than 80 years
* Pregnant women
* Non-adherent to anti-hypertensive treatment
* Severe cognitive deficits
Spanish Retrospective Study to Evaluate the Efficacy and Safety of Targeted Therapies After Pazopanib as First-line Therapy

The purpose of this retrospective observational study was to analyze the effect of targeted therapies administered as second-line treatment after failure of pazopanib as well as increase the amount of information available on efficacy and safety of pazopanib as a first-line therapy in practice usual for the clinical treatment of metastatic Renal Carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18.
* Metastatic renal cell cancer of any histology.
* Patients treated with pazopanib for metastatic cell renal cancer outside the context of clinical trials (clinical practice) in Spanish centers from 1 April 2011 until 30 June 2014. shall be included all patients who received pazopanib as first-line treatment in each participating center, whether had experienced treatment failure with pazopanib or were still in first-line treatment. The inclusion of patients who are also allowed received cytokine as first-line treatment followed by pazopanib as well as patients who received sunitinib as first-line treatment and have changed pazopanib for toxicity or intolerance, provided they have not received more a cycle of sunitinib.
* Centers that agree to participate must commit to: · Include all patients meeting the inclusion criteria to reduce by possible selection bias. Because it supplies only pazopanib Hospital pharmacy service (not outside hospitals), the identification of patients will be performed at the hospital pharmacy records in each participating center.

Exclusion Criteria:

* Patients who received pazopanib in clinical trials or treatment second line, with the exceptions noted above.
* Patients with the diagnosis and / or treatment of malignancies of importance other than Cell renal cancer.
Hepatic Fibrosis Assessment Using Multiparametric Magnetic Resonance Imaging

The purpose of this study is to assess degree of hepatic fibrosis using multiparametric MRI for investigating difference between normal or early fibrosis and advanced fibrosis.

In patients with liver parenchymal disease or normal liver parenchyma who are scheduled to undergo either liver resection or liver biopsy are included.

Referred patients undergo multiparametric MRI including perfusion, diffusion, elastography and fat quantification before surgery or biopsy.

The pathophysiologic changes are evaluated using multiparametric MRI, and compared between normal/early fibrosis and advanced fibrosis.

Eligibility Criteria:
Inclusion Criteria:

* patients who are scheduled to undergo liver resection for focal liver lesion
* patients who are scheduled to undergo liver resection or percutaneous biopsy for diffuse parenchymal disease
* liver donor candidate who are scheduled to undergo preoperative liver biopsy or liver resection
* AND patients/living donor candidates who sign informed consent

Exclusion Criteria: Patients who have at least one of followings are excluded.

* Patients who are contraindication for MRI contrast enhanced MRI.
* Premenopausal female patients who are pregnant.
* Patients who are physically compromised to acquire liver MRI
Effect of Vestibular Rehabilitation Therapy on Patients With Brain Radiological Findings That Affect Balance Functions

Occurrence of cerebrovascular diseases, particularly of cerebral small vessel disease (SVD), appears to play some role in the development of gait and balance impairment . Beside small vessel disease , stroke is one of the most common cause of long-term adult disability leading to cognitive and motor function impairments. Particularly, gait and balance disorders that may contribute to immobility and falls.

The design of personalized rehabilitation protocols, focused on the recovery of dynamic balance ability would be fundamental to reduce these deficits and consequently, the risk of falling, thus improving patients' quality of life. Vestibular rehabilitation therapy (VRT) is an exercise-based treatment program designed to promote vestibular adaptation and substitution. The goals of VRT are to enhance gaze stability, to enhance postural stability, to improve vertigo, and to improve activities of daily living. VRT facilitates vestibular recovery mechanisms: vestibular adaptation, substitution by the other eye-movement systems, substitution by vision, somatosensory cues, other postural strategies, and habituation .


Eligibility Criteria:
Inclusion Criteria:

* Age: from 40 years to 60 years old.
* Sex: males and females.
* Can withstand and willing to undergo repeated CDP trials.
* No evidence of orthopedic problems, neurological or cardiovascular diseases. - No history of any disease required to give treatment that could affect results.

Exclusion Criteria:

* Geriatric population , above age 60 years old.
* Patients with orthopedic problems , neurological or cardiovascular diseases.
Efficacy and Safety of Tulobuterol Patch Combined With Tiotropium Bromide for Relieving Dyspnea Symptom of Chronic Obstructive Pulmonary Disease

Phrase: IV

Indication: dyspnea symptom of chronic obstructive pulmonary disease (COPD)

Objective: to evaluate efficacy and safety of tulobuterol patch combined with Tiotropium bromide for relieving dyspnea symptom of COPD

Design: a multi-centre randomized parallel blank control study

Case number: test group 80, control group 80, totally 160

Site number:7

Study period: 2010.9 - 2011.8


Eligibility Criteria:
Inclusion Criteria:

* people aging from 40 to 80 with self ability of judgment
* out-patients diagnosed as stable COPD according to "diagnosing and treatment guideline of COPD (2007 edition)" by Respiratory Department of Chinese Medical Association
* PFT value at screen phase meet the standard as follows: FEV1/FVC \< 70% and FEV1% among 30%-80% 15 mins after inhalation of 400ug Ventolin (i.e., moderate and severe COPD patients ).
* people who can use Tiotropium Bromide powder inhalation device
* people who join the study voluntarily and sign ICF (Informed Consent Form)

Exclusion Criteria:

* people who have other acute or chronic respiratory diseases which may cause impairment of pulmonary function such as asthma
* AECOPD （acute exacerbation of COPD）
* people who got respiratory failure 1 month before the study
* people who received oral corticoid treatment 1 month before the study
* people who undergo oxygen therapy at home because of respiratory failure
* people who are allergic to β2 receptor agonist such as tulobuterol
* patients with Skin diseases such as atopic dermatitis, who are not appropriate to use transdermal patch
* patients of hyperthyroidism, hypertension, heart disease and severe arrhythmia, diabetes mellitus, who are not appropriate to useβ2 receptor agonist
* patients who have undergone pulmonary lobectomy or have tumor
* active tuberculosis patients
* people who got acute respiratory tract infection in a month or during screening phase
* allergic rhinitis patients
* glaucoma patients
* people who have diseases which may cause dysuria such as prostatic hypertrophy or bladder neck occlusion
* gestation, lactation and child-bearing age women who don't agree to take contraceptive measures during the study
* people with abnormal live or kidney function, people with nervous system diseases, malignant tumor, neutropenia or other progressive basic diseases.
* People who are mental retardation, mentally ill, deaf-mute or uncooperative, who cannot correctly describe their disease or do corresponding respiratory questionnaire.
* People who are allergic to atropine and its derivatives (including tiotropium bromide and ipratropium bromide), lactose or any inhalant components.
* people who have taken part in other medical clinical trial
* other conditions that investigators think not appropriate for the study
e-Nature VR: Evaluation of the Impact of Virtual Reality During Breast Biopsy

Randomized clinical trial about the evaluation of the impact of the virtual reality intervention on the experience of pain, physical and psychological discomfort, well-being and anxiety of women during breast biopsy use of nature virtual reality video.

Breast biopsy is one of the main tests for the diagnosis of cancer, which generates emotional distress and can be a painful procedure. Distraction has considerable efficacy among mild psychological methods for reducing pain perception. Virtual Reality is the most advanced technology of distraction, with the highest level of immersion in virtual worlds and effective results as a non-pharmacological measure in pain perception. However, audiovisual resources related to nature have not yet been investigated in this clinical setting.

This clinical trial aims to verify the impact of the virtual reality intervention on the experience of pain, physical and psychological discomfort, well-being and anxiety of women during breast biopsy; its influence on the time of the examination; the degree of recommendation of the intervention; and if the connection with nature interferes in the results obtained on the studied variables. The Immersive Reality intervention will be provided during the breast biopsy and the variables will be evaluated using Likert-type scales and pain using the Analog Virtual Scale. Our study hypothesis is that this intervention reduce the perception of pain / discomfort during the biopsy by connecting with nature, reducing anxiety, exam time, and increasing the sense of well-being.

Eligibility Criteria:
Inclusion Criteria:

* Voluntary participation;
* Signed in the Informed Consent Form;
* Patients with clinical conditions and preserved communication function, in other words, lucid patients;
* Patients in breast biopsy procedure.

Exclusion Criteria:

* Blind patients;
* Patients without the capacity for judgment, in other words, with dementia;
* Patients who have their clinical condition changed during the breast biopsy. Patients with history of nauseas vertigo and labyrinthitis