cyrilzakka/clinical-trials huggingface dataset:
The Use of Electrical Stimulation for Determination of Epidural Catheter Placement

The aim of this study is to address the problem of epidural failure. The investigators theorize epidural failure can be due to inappropriate catheter movement and this may be related to the length of which the epidural catheter is inserted. The investigators will use electrical stimulation to determine if the catheter moved in the sacral direction with insertion.

The research participants will be pregnant women in Labor and Delivery ward of Stanford University hospital who request an epidural for labor analgesia.

In this study the patients will receive an epidural catheter in the same way as standard of care. The catheter will be inserted to 20cm and then electrically stimulated to document where it is placed by looking at the muscles effected. The catheter is then pulled back in 5cm increments and stimulated until the standard distance is achieved. For example, if loss of resistance happened at 5cm, the catheter would be inserted to 20cm, stimulated, pulled back to 15cm and stimulated, and finally to 10cm and stimulated.

Electrical stimulation of epidural catheters for confirmation of placement is a published and accepted technique. In this study, the investigators will perform electrical stimulation at incremental points during catheter pull back with documentation of where stimulation was seen.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant female requesting epidural for labor analgesia.
* Must meet standard inclusion criteria for safe epidural placement.
* Platelet count over 70,000, INR under 1.3.

Exclusion Criteria:

* Unable to safely place epidural catheter due to commonly accepted patient factors.
Massage in Treating Painful Shoulder

The purpose of this study is to compare classical massage and massage based on the tensegrity rule in treating people with painful shoulder.

The joint system of the shoulder girdle is exposed to frequent overloading, which can cause painful shoulder. The therapeutic methods applied in the treatment of painful shoulder syndrome include among others oral pharmacotherapy, joint injections, kinesitherapy, ultrasound, electrotherapy, laser. Manual therapy, chiropractic and surgery could also be used. Attempts have also been made to apply classical massage in treating painful shoulder, although it is not often used due to its low effectiveness.This study compares classical massage and massage based on the tensegrity rule which is not commonly known.

Eligibility Criteria:
Inclusion Criteria:

* painful shoulder syndrome

Exclusion Criteria:

* acute pain
* previous bones fracture
* bone relocations in the area of the shoulder girdle
* neck spondylosis
* hemiparesis
* rheumatoid arthritis
* any neurological symptoms
Trustworthy, Integrated Artificial Intelligence Tools for Predicting High-risk CORonary PlaqueS

Coronary artery disease (CAD) is among the leading cause of death and disability. Identification of patients at high risk of cardiovascular events is pivotal. However, current risk stratification based on imaging and known biomarkers is suboptimal. The objective of this proposal is to develop a multicriteria decision model for non-invasive assessment of vulnerable atherosclerotic patients and to evaluate its ability to predict the occurrence of an adverse event in intermediate-to-high risk patients with suspected or known CAD. The planned workflow includes a first step using a retrospective cohort of patients undergoing clinically indicated coronary angiography (CCTA) to develop an integrated application for automatic coronary artery segmentation, quantitative plaque analysis, biomechanics and fluid dynamics, based on machine learning, radiomics and computational analysis approaches and validated against the reference standard for each tool. The second step will apply this new methodology to a larger retrospective cohort of patients with the integration of genomic biomarker assessment to derive the most accurate risk stratification model to properly identify vulnerable patients and vulnerable plaques with respect to outcome. Finally, in the third step, the derived predictive model will be prospectively validated in an independent cohort of patients from an ongoing study (CTP-PRO study) to assess the robustness and accuracy of the proposed solution.


Eligibility Criteria:
Inclusion Criteria:

* patients (age ≥ 18 years) with known or suspected CAD referred for clinically indicated diagnostic evaluation;
* CCTA performed with state-of-the-art scanner technology, i.e., scanners with more than 64 slices.

Exclusion Criteria:

* performance of any non-invasive diagnostic test within 90 days before enrolment;
* low-to-intermediate pre-test likelihood of CAD according to the updated Diamond-Forrester risk model score;
* acute coronary syndrome;
* evidence of clinical instability;
* contraindication to contrast agent administration and/or impaired renal function;
* inability to sustain a breath hold;
* pregnancy;
* cardiac arrhythmias;- presence of a pacemaker or implantable cardioverter defibrillator;
* contraindications to the administration of sublingual nitrates, β-blockers or adenosine;
* structural cardiomyopathy
Efficacy/Safety of Octreotide Acetate in Patients With Uncontrolled Acromegaly

This study evaluated the safety and efficacy of an increased frequency of octreotide acetate injections or an increase in dose in partially responsive acromegalic patients with persistently uncontrolled disease.


Eligibility Criteria:
Inclusion Criteria:

* Written voluntary informed consent.
* Patients with biochemically documented active acromegaly who are currently receiving somatostatin-analogues in a conventional treatment regimen (octreotide up to 30 mg/28 days; lanreotide up to 120 mg/28 days) for at least 6 months.
* Patients with uncontrolled disease defined as patients with a decrease of baseline levels of growth hormone (GH) ≥ 50% during treatment with somatostatin-analogues in a conventional regimen (sandostatin up to 30 mg/28 days; lanreotide up to 120 mg/28 days) for at least 6 months.
* Baseline (mean of 3 samples) GH level \> 2 µg/L.
* Insulin-like Growth Factor I (IGF-I) levels above the upper limits of normal for age and gender.

Other protocol-defined inclusion/exclusion criteria applied to the study.
Safety and Efficacy of an Ophthalmic Solution in Dry Eye Disease

The purpose of this study is to investigate the safety and efficacy of an ophthalmic solution in dry eye disease.


Eligibility Criteria:
Inclusion Criteria:

* Subjects 18 years of age or older

Exclusion Criteria:

* No active ocular conditions of disease
Analgesia After Total Knee Arthroplasty: Peri-Articular Injection Versus Epidural + Femoral Nerve Blockade

There are 2 common ways to manage pain after total knee arthroplasty at our institution. Some patients receive an epidural analgesia, a femoral nerve block and pills for pain. More recently, some surgeons have replaced femoral nerve blockade with peri-articular injections. These patients receive a peri-articular injection (injection of pain medication around the knee), pills for pain and a pain patch on the skin. The purpose of this research project is to find out if one of these ways to treat pain is better than the other. The investigators will look at this question in many ways, but the main way is how long it takes for you to be judged ready for discharge from the hospital.


Eligibility Criteria:
Inclusion Criteria:

* Patients with osteoarthritis scheduled for primary bicompartmental total knee arthroplasty with a participating surgeon
* Age 18 to 85 years old
* Planned use of regional anesthesia
* Ability to follow study protocol
* Up to 15 degrees varus, up to 15 degrees flexion and up to 15 degrees valgus

Exclusion Criteria:

* Patients younger than 18 years old and older than 85
* Patients intending to receive general anesthesia
* Allergy or intolerance to one of the study medications
* Patients with an ASA of IV
* Patients with insulin-dependent diabetes
* Patients with hepatic (liver) failure
* Patients with chronic renal (kidney) failure
* Chronic opioid use (taking opioids for longer than 3 months)
* Patients with any prior major ipsilateral open knee surgery.
* Patients with flexion contracture of knee \> 15 degrees
* Patients with varus deformity \> 15 degrees
* Patients with valgus deformity \> 15 degrees
* Patients with a contraindication to use of epinephrine
A Study of Cebranopadol for the Treatment of Acute Pain After Abdominoplasty

The purpose of this study is to evaluate the efficacy and safety of Cebranopadol for acute pain after a Abdominoplasty.

This study is a Phase 3, multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Cebranopadol for the Treatment of Moderate to Severe Acute Pain after Full Abdominoplasty. This study will be conducted in 3 phases: Screening, Treatment, and Follow-up.

Eligibility Criteria:
Key Inclusion Criteria:

* Scheduled to undergo full abdominoplasty procedure without liposuction or other collateral procedures, using anesthesiologic and surgical procedures planned as described in this protocol.
* Must be able to adhere to the visit schedule, complete all study assessments, and protocol requirements including self-reported questionnaires.

Key Exclusion Criteria:

* Any clinically significant disease, medical condition or laboratory finding that in the investigator's opinion may interfere with the study procedures or data integrity or compromise the safety of the subject.
* Subject has a current painful condition that could confound the interpretation of efficacy, safety or tolerability data in the study, in the opinion of the investigator.
* History of allergy, hypersensitivity or intolerance to any opioid analgesics or anesthetics, including opioid-induced nausea or vomiting.
Cardiovascular Impairments and Obstructive Sleep Apnea Syndrome

Which are the anthropometric parameters and/or of severity of the syndrome of apnea of sleep (SAS) which make it possible to anticipate occurred of vascular anomalies, anatomical and/or functional precociously found among patients SAS? Secondary objectives:

1. Which are the anthropometric parameters and/or of severity of SAS allowing to anticipate occurred of early of the cardiac function and/or rhythmic anomalies found among patients SAS?
2. Do there exist biological markers who allow to anticipate the early vascular lesions or the anomalies beginners of the cardiac function?
3. Which are the cardiovascular effects of a treatment of SAS by Continuous Positive Pressure (PC) after 3 to 6 months of treatment?
4. Do the identified early cardiovascular attacks and/or the biological anomalies make it possible to predict occurred of cardiovascular events in this population of patients carrying SAS (followed longitudinal at 5 years)?


Eligibility Criteria:
Inclusion Criteria:

* Male or female from 18 to 78 years old
* Patients with obstructive sleep apnea syndrome (Apnea/Hypopnea index \> 15)
* ambulatory patients
* patients who have signed the inform consent form
* patients with health insurance

Exclusion Criteria:

* Body Mass Index upper or equal to 30
* cardiovascular pathology except blood pressure hypertension
* known or treated diabetes
* pathologies with consequence on blood pressure regulation
* drugs intakes with consequence on blood pressure regulation
* patient with chronic obstructive pulmonary disease
* atrial fibrillation or more than 10/minute extrasystoles
* bedridden patients or patients with decreased mobility
* patients working at night or with shift work
* patients with carotid stenting or surgery history
* patients unable to sign the inform consent form
* patients already treated by cPAP or dental appliance for OSAS in the last 6 months
* pregnant or suckling female
* patients under supervision or trusteeship
* patients taking part in another clinical trial
A Trial of SHR-1802 in Patients With Failure of Standard Treatment for Advanced Malignant Tumours

This is the first study to test SHR-1802 in humans. The primary purpose of this study is to see if SHR-1802 is safe and tolerable for patients with locally advanced/unresectable or metastatic malignancies that are refractory to available therapy or for which no standard therapy is available.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntary participation and written informed consent;
2. Aged 18-75 years (inclusive), males and females;
3. Patient must have histologically or clinically confirmed advanced and/or metastatic malignancies for which failure of standard treatment or lack of effective standard treatment;
4. At least one measurable lesion according to RECIST v1.1;
5. ECOG score of 0-1;
6. Expected survival ≥ 12 weeks;
7. Adequate bone marrow reserve and organ function were confirmed by baseline examination
8. For female patients of childbearing potential or male patients with partners of childbearing potential who are not sterilized by surgical operations, they are required to use a medically approved contraceptive measure during the study treatment period and within 3 months after the end of the study treatment; For female patients of childbearing potential who are not sterilized by surgical operations, they must have a negative serum HCG test result within 72 h prior to study enrollment; and they must not be in the lactation period;

Exclusion Criteria:

1. The presence of any active, known, or suspected autoimmune disease. Type 1 diabetes, which was admitted to receive stable dose of insulin, hypothyroidism, which required only hormone replacement therapy, skin disease with no need to systemic treatment and no acute exacerbation within 1 year before the screening period;
2. Subjects who had received systemic treatment with corticosteroids or other immunosuppressive agents within 28 days prior to initial administration.
3. Known and untreated central nervous system (CNS) or leptomeningeal metastases;
4. Uncontrolled pleural effusion,or ascites requiring recurrent drainage procedures;
5. Uncontrolled cardiac diseases or symptoms;
6. Known hereditary or acquired bleeding and thrombotic tendencies;
7. Patients who have previously received chemotherapy, radiotherapy or surgery which ended within 4 weeks prior to the start of this study; oral molecular targeted therapy with \< 5 drug half-lives from the first study dose; or patients with AEs caused by previous treatment (except for alopecia) that have not returned to CTCAE Grade ≤ 1;
8. Known active infection,;
9. Congenital and acquired immune deficiency;
10. HBsAg-positive and HBV DNA \> 2000 IU/mL(or 104 copies/mL); HCV RNA copies \> ULN;
11. Patients with other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring concomitant treatment, serious laboratory abnormalities, or family or social factors that could affect the safety of the patients.
Comparison of Pain Therapeutic Effects After Benign Mastectomy

With the incremental trend of benign breast tumor, the surgical process of mastectomy was proceeded too much every day, especially in the Maternal Health Care Hospital, but whether the investigators can find another way to relieve the postoperative pain after such an operation is still unknown. The investigators hypothesized that the pain from the relatively small surgery may not be significant compared to different treatments, even if no drug was delivered to them. The investigators are enrolling patients who underwent mastectomy from benign breast tumor, and are observing the analgesic effects of different drugs.


Eligibility Criteria:
Inclusion Criteria:

* Chinese
* No cardiac and pulmonary diseases
* ASA I-II
* No alcohol drinking.

Exclusion Criteria:

* \<19yrs, and \>65yrs
* History of central active drugs administration
* Drug abuse
* Hypertension
* Diabetes
* Any other chronic diseases.
Capecitabine and Oxaliplatin in Treating Older Patients With Metastatic Colorectal Cancer

RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well giving capecitabine together with oxaliplatin works in treating older patients with metastatic colorectal cancer.

OBJECTIVES:

Primary

* Determine the efficacy of capecitabine and oxaliplatin as first-line treatment, as defined by stabilization or improvement by 1 point on Katz's Activities of Daily Living scale, in older patients with metastatic colorectal adenocarcinoma.

Secondary

* Determine the toxicity of this regimen in these patients.
* Determine the percentage of patients who receive the first 3 courses of this regimen (at lower doses) and the percentage of patients who receive all 6 courses of this regimen (at both lower and higher doses).
* Determine efficacy of this regimen, as defined by RECIST criteria, in these patients.
* Determine the pharmacokinetics of this regimen in these patients.

OUTLINE: This is a multicenter, open-label, nonrandomized study.

Patients receive oral capecitabine\* once daily on days 1-14 and oxaliplatin\* IV on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

NOTE: \*The doses of both capecitabine and oxaliplatin are increased in courses 4-6 in the absence of unacceptable toxicity

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of colorectal adenocarcinoma

  * Metastatic disease
* Requires first-line therapy for metastatic disease

PATIENT CHARACTERISTICS:

Age

* Over 70

Performance status

* Katz's Activities of Daily Living scale \< 6 (≤ 6 for patients ≥ 80 years of age)

Life expectancy

* More than 3 months

Hematopoietic

* Absolute neutrophil count \> 1,500/mm\^3
* Platelet count \> 100,000/mm\^3

Hepatic

* AST and ALT \< 2 times normal (5 times normal if due to hepatic metastases)
* Bilirubin \< 2 times normal (5 times normal if due to hepatic metastases)

Renal

* Creatinine clearance \> 30 mL/min

Other

* No clinical neuropathy

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* More than 6 months since prior adjuvant chemotherapy
* No prior chemotherapy for metastatic disease

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified
Generalized Fear Extinction to Untreated Fear Stimuli in Specific Phobias After Exposure

This study investigates whether a one-session exposure treatment for spider-related stimuli can lead to a generalization of extinguished fear to height-related stimuli in individuals with comorbid fear of spiders and fear of heights.

Exposure therapy has been proven to be effective in the treatment of specific phobias and in a variety of fear evoking situations and stimuli. However, since there is a high prevalence of comorbid fears, therapeutic interventions can get very extensive when each fearful situation and / or stimuli needs to be treated separately and over a repeated number of times. It has recently been shown, that exposure to one fearful stimuli (i.e., a spider), can also lead to a reduction of fear to another, perceptually and conceptually related, but untreated fearful stimulus (i.e., a cockroach) (Preusser, Margraf \& Zlomuzica, 2017). Potentially, this generalization of exposure effects might also be relevant for coexisting fears that do not share conceptually related fearful stimuli (e.g., fear of spiders and fear of heights). The present study aims to investigate whether successful exposure treatment to one fearful stimulus (i.e., a spider) can also lead to a reduction of fear to an untreated fear evoking stimulus (i.e., height).

Participants will be randomly assigned to the treatment or no-treatment condition. The entire experimental procedure will take place in three sessions. The first session incorporates spider and height fear related questionnaires and two Behavioral Approach Tests (BATs): One that involves a spider and one that involves height. These BATs are counterbalanced in each group with half of participants receiving the spider BAT first and the height BAT second, and vice versa. The second session takes place approximately seven days later. The treatment group receives a seven-step in vivo exposure with spiders (duration: 1,5 hours). Twenty-four hours later, session 3 takes place and involves the same measures that were applied in session 1. The treatment and no-treatment group receive an identical set of measures except that the no-treatment group will not be subjected to exposure. The effects of exposure-based anxiety reductions toward spiders (treated fear stimulus) and heights (untreated fear stimulus to assess generalization of treatment outcome) are assessed on the behavioral and subjective level at pretreatment and posttreatment (24 hours after exposure).

Eligibility Criteria:
Inclusion Criteria:

* Comorbid presence of fear of spiders and fear of heights \[Potential diagnosis of specific phobias (arachnophobia and acrophobia) assessed by application of the Diagnostic Short-Interview for Mental Disorders (Mini-Dips)\].

Exclusion Criteria:

* Any acute or chronic mental and / or somatic disease
* Psychological, psychiatric, neurological or pharmacological treatment (Application of the Mini-DIPS to screen for the presence of a psychological condition)
* Drug or alcohol abuse
* Pregnancy
Whole Body MRI to Identify Atypical Neurofibromas in Patients With NF1

This study is being conducted to determine if Whole Body MRI (WBMRI) can be used to identify Atypical Neurofibromas (ANF) in Neurofibromatosis Type 1 (NF1) patients with high tumor burden. Each enrolled participant will have two (2) WBMRIs without sedation during the study period. Eligible participants must be Male or Female between the ages of 8-30 with diagnosed NF1; with one or more PN greater than 3cm in diameter and willing to comply with study procedures.

This is a study to determine the feasibility of using Whole Body MRI (WBMRI) to detect Atypical Plexiform Neurofibromas (ANF) among Neurofibromatosis Type 1 (NF1) patients who are at highest risk for developing these tumors. In order to do this, the investigators will prospectively obtain WBMRI scans on patients with high plexiform tumor burden (which investigators will define as \>=1 plexiform neurofibroma (PN) that is \>3cm in diameter on MRI) at the same time as their regularly scheduled MRI to allow for radiographic comparison of the identified PNs. In this study, the investigators will plan to establish a method that effectively characterizes PNs in terms of their volume, radiographic appearance on WBMRI and association with clinical characteristics.

As an exploratory aim, the investigators plan to collect blood samples from each patient at the same time as the MRI to determine the feasibility of isolating cfDNA (circulating free DNA) from plasma of patients with high plexiform tumor burden.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females between 8-30 years of age
2. Confirmed diagnosis of NF1
3. Stated willingness to comply with all study procedures and availability for the duration of the study
4. Prior MRI documentation confirming \>=1 PN that is \>3cm in diameter

Exclusion Criteria:

1. Unable to undergo MRI without sedation
2. Presence of metal or other devices that are contraindicated for MRI