cyrilzakka/clinical-trials huggingface dataset:
Pre-procedural Anxiety and Sedation.

Colonoscopy is an outpatient procedure performed frequently as a screening test for diagnosis and treatment of a wide range of gastrointestinal problems. It is often viewed as an invasive procedure with the potential for embarrassment, discomfort, and worry. Such fears can result in anxiety that may decrease the tolerance and cooperation of the patient, limit the success of the procedure, and increase the likelihood of complications. Therefore, colonoscopy is frequently performed under sedation. The anxiety level of the patient before the procedure may increase the requirement for sedation. It is important for the anesthesiologist to predict the effective dosages of sedation before the procedure to ensure rapid and comfortable sedation as well as prompt recovery and discharge of the patient.

This prospective cohort study is planned to evaluate the effects of pre-procedural anxiety level on the dose of propofol needed for patient and surgeon satisfaction during colonoscopy.

Patients scheduled for elective colonoscopy for screening are enrolled. On the day of the procedure, demographic data are collected and all patients are asked to complete the Spielberger State-trait Anxiety Inventory (STAI-I and STAI-II) in an isolated, calm room before being transferred to the procedure room.

All patients are monitored with electrocardiogram, pulse oximetry, noninvasive blood pressure and bispectral index measurement at 5-min intervals.

Oxygen is administered at 4 L/min via a face mask, Propofol 2% infusion is started via an effect-site target controlled infusion system (Marsh model).

Once the patient reaches the desired level of sedation as determined by BIS value of 60, the procedure is started.

This monitorization and sedation protocol is the routine management of outpatient colonoscopies and gastroscopies in our institution.

For this study the patients' anxiety levels are evaluated with the STAI score. This is not an intervention but an evaluation of the patients. Drug dosing or sedation management are not adjusted according to the anxiety scores but are calculated with the patients' weight.

During the procedure:

* hemodynamic parameters
* the total propofol dosage
* the number of TCI interventions
* complications (respiratory depression, need for ventilation, nausea, vomiting, laryngospasm, and agitation)
* the procedure duration
* surgeon satisfaction with sedation instrument scores are recorded.

These collected data are studies to determine a correlation between the propofol dose and the pre-procedural anxiety of the patients.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anaesthesiology Physiologic assessment score I-II patients
* 18-65 years old
* planned elective colonoscopy under sedation

Exclusion Criteria:

* the use of anxiolytic medications
* history of colonic resection or any intraabdominal surgery
* predicted allergy to propofol
* patients refusing sedation
A Net Ultrafiltration Challenge to Predict Preload-dependence (UF CHALLENGE)

Hemodynamic instability episodes are a frequent complication of renal replacement therapies in critically ill patients, and their incidence is associated with worse survival. Hypovolemia, identified by the existence of biventricular preload dependence, is responsible for one episode out of two, and may justify a decrease in or cessation of fluid removal by net ultrafiltration (UF). To date, preload dependence is most frequently identified by evaluating the effects on cardiac output of postural changes (passive leg raising), impact of cardio-pulmonary interactions in ventilated patients, or fluid challenge. However, none of these tests may help identify a patient whose cardiac output is at risk of becoming preload dependent, that is situated at the inflexion point of the Frank Starling curve.

Our study aims to evaluate the effects on cardiac output (measured by a transpulmonary thermodilution technique) of 2 net ultrafiltration challenges, consisting fast removal of 250 ml of ultrafiltrate over 15 and 30 minutes respectively, and compare their diagnostic performance to the reference technique of preload dependence assessed by postural changes (passive leg raising) performed after the UF challenge.

Enrolled participants will undergo both UF challenges, following a randomized crossover design, in which the order of UF challenge duration (15 or 30 minutes) is randomized, separated by a washout period of 24 hours.


Eligibility Criteria:
Inclusion Criteria:

* adult patient, aged 18 year or older
* under mechanical ventilation and continuous general anesthesia, with a positive end-expiratory pressure of 5 cmH2O or more
* with stage 3 KDIGO acute kidney injury
* treated with continuous renal replacement therapy for less than 14 days
* ongoing continuous cardiac output monitoring
* with a predicted intensive care length of stay of 24 hours or more at time of screening

Exclusion Criteria:

* High arterial lactate concentration, \> 4.0 mmol/L at time of screening
* Calibrated cardiac index \< 2.0 L/min/m2 or \> 4.0 L/min/m2 at time of screening
* Positive postural change maneuver in the last 2 hours preceding screening
* Patient under extracorporeal membrane oxygenation
* Patient with active bleeding requiring emergent transfusion
* Patient under chronic maintenance dialysis or renal transplant recipient
* Acute ischemic or hemorrhagic stroke complicated with coma and requiring mechanical ventilation
* Fulminant hepatitis (acute liver injury, hepatic encephalopathy, icterus and a drop in prothrombin \< 50% in less that 15 days
* Impossible postural change maneuver
* Pregnant or lactating patient
* Imminent death
* Patient under legal protection measures as by French regulation
* Patient already enrolled in the present study
* Patient already participates in a study with protocolized net ultrafiltration, ongoing at time of screening
Effect of Postoperative Ketorolac on Bone Healing After Joint Fusion

In the midst of the opioid crisis, the use of non-narcotic pain medication has garnered increased interest, particularly in the field of orthopaedic surgery, where narcotic medications are routinely prescribed postoperatively. Nonsteroidal anti-inflammatory drugs (NSAIDs) have the potential to serve as an adjunct analgesic, but many orthopaedic surgeons have viewed NSAIDs with hesitancy because of evidence that they can lead to delayed bone healing.

When evaluating bone healing across different NSAID formulas, ketorolac was found to cause no delay and lead to better union rates when compared to controls and other NSAIDs, respectively. Previous studies in the orthopaedic spine and trauma literature have suggested a detrimental effect of NSAIDs, specifically ketorolac, with regards to bone healing, while others have reported no delay in healing. A recent study from our institution found no detrimental effects on the healing of ankle fractures with the use of ketorolac in the immediate postoperative period. Additionally, the use of ketorolac was associated with less reliance on narcotic pain medications.

The purpose of this prospective randomized study is to evaluate the use of ketorolac on postoperative pain, opioid requirements, patient satisfaction, complication/reoperation rates, and delayed and/or nonunion rates in patients undergoing fusion of their first metatarsophalangeal joint (1st MTPJ) for treatment of end-stage arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 undergoing outpatient primary 1st MTPJ fusion by a fellowship-trained foot and ankle orthopaedic surgeon at the Rothman Orthopaedic Institute

Exclusion Criteria:

* Patients undergoing revision 1st MTPJ fusion;
* Patients with any allergies to any study medication;
* Patients with documented chronic narcotic use;
* Patients with renal insufficiency, as defined by history and preoperative creatinine level (Cr ≥ 2.1 mg/dl);
* Patients who are pregnant;
* Patients undergoing inpatient procedure.
Identifying and Treating Physical Function Impairment in Elders

Sedentary older adults are more likely to develop physical function impairments than active older adults. Physical function measured by slow usual gait speed predicts the risk of future falls, disability, institutionalization and mortality. Behavioral physical activity interventions have improved physical activity and physical function, but have not generally been implemented where they may have the most impact -- primary care settings. In part, this is due to the limited time and training for clinical staff to screen for physical function impairment and to treat with physical activity counseling. The proposed scientific goal is to overcome these barriers by adapting an evidence-based screening tool and telephone-based physical activity intervention into primary care settings.

Aim1: Among older adults who screen positive for physical function impairment, to determine the estimated intervention effect size of a 12-week behavioral intervention on physical activity and physical function.

Hypothesis 1a: Physical activity levels will increase more in the intervention vs. usual care group.

Hypothesis 1b: Physical function will increase more in the intervention vs. usual care group.

Aim 2: Among Aim 1 participants and clinical staff who deliver the functional screening and Aim 1 intervention, to evaluate standard implementation science process metrics of reach, acceptability, and implementation


Eligibility Criteria:
Inclusion Criteria:

* Sedentary patients aged 65-85 years who screen positive for physical function impairment (Physical function impairment includes any of the following: time to complete 4-meter walk ≥4.82 seconds (i.e., ≥0.83 meters/second); a reported fall in the past 3 months; or a reported fear of falling)

Exclusion Criteria:

* Inability to walk ≥30 feet without human assistance7
* Dementia, as assessed by either a Folstein Mini-Mental Status Examination \<24 or by patient's primary care provider's assessment
* Severe vision loss (legally blind)
* Severe hearing loss
* Medical condition that precludes increasing physical activity per primary care provider's assessment
* Terminal diagnosis per primary care provider's assessment
Search Tolerance Signature in Vascularised Composite Allograft

Composite tissue allotransplants (CTA) involve transplantation of various tissues including vessels, nerves, skin, bones, and immune cells and entail a significant antigenic load. The large majority of recipients have been maintained on immunosuppression therapy similar to that used in solid organ transplantation that is associated with the complications usually reported in solid organ transplantation. The question whether risks associated with indefinite immunosuppressive are justified for a non-lifesaving procedure still remains unanswered. At present no CTA recipient proved to be spontaneously tolerant with any immunosuppressive protocol; indeed, until now all recipients who discontinued the immunosuppressive therapy rejected their graft. On the other hand CTA recipients showed a low incidence of chronic rejection despite the high incidence of acute rejection episodes.

For all these reasons it should be of great interest to minimize the immunosuppression in CTA patients knowing their immunologic "risk". The main outcome of this study is to search for the signature of tolerance in recipients of hand or face allotransplantation testing biomarkers previously identified in operational tolerant kidney transplant recipients.

These markers have been developed studying tolerant kidney recipients and they were already tested in five bilateral hand transplantations and one face transplantation.

The present study will include hand and face allograft recipients transplanted at least one year in several European institutions (Innsbruck, Lyon, Monza, Valencia): 11 bilateral hand transplantations, 4 single hand transplantations and 3 face transplantations. All the patients will undergo B cell phenotyping, TCR repertoire, molecular signature from operational tolerance and a skin biopsy with immunohistochemical staining of the specimens in order to show signs of acute or chronic rejection.

The results could provide a valid tool to detect operationally tolerant recipients as well as recipients prone to develop chronic rejection.


Eligibility Criteria:
Inclusion Criteria:

* Patient with Hand (unilateral/bilateral) or face allotransplantation for at least one year
* Patient without clinical sign of acute rejection at inclusion
* Patient who signed the informed protocol consent
* Patient older than 18 years old
* Patient covered by an health insurance
* Patient without legal protection

Exclusion Criteria:

* Patient with Hand or face allotransplantation for less than one year
* Patient with clinical sign of acute rejection at inclusion
* Unsigned protocol consent
* Patient under the age of 18 years old
Tranexamic Acid as an Intervention in Placenta Previa

Antepartum hemorrhage (APH) due to placenta previa is an important cause of worldwide perinatal mortality and maternal morbidity in pregnant women

Antepartum hemorrhage (APH) due to placenta previa is an important cause of worldwide perinatal mortality and maternal morbidity in pregnant women. No medication is of specific benefit to a patient with placenta previa. Tocolysis may be cautiously considered in some circumstances in order to administer antenatal corticosteroids. A review article concluded that there is no improvement in perinatal outcome with prolonged tocolytics, and tocolysis beyond 48 hours is not clinically indicated.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant at 28 weeks gestation and more
* Vaginal bleeding due to placenta previa
* Stable hemodynamically
* Accept to participate in the trial

Exclusion Criteria:

* Hypersensitivity to tranexamic acid
* Acquired defective color vision
* History of venous thromboembolism
* Pre-existing medical conditions (diabetes mellitus, hypertension, renal disease)
* Smokers
* Refused to participate in the trial
Effects of Transcutaneous Electrical Nerve Stimulation on Cognitive Function and Upper Limb Motor Function in People With Chronic Stroke

Upper limb impairment is present in more than 85% of people with stroke, which greatly affect the quality of life, social participation, and performance of daily activities of people with stroke. Previous study also revealed that 53.4% of people after stroke experienced cognitive impairment. Different cognitive domains might be affected following stroke, such as attention, memory, language, and orientation, and the problems with memory are often prominent. Yet, there is no effective treatment for the post-stroke cognitive impairment.

Transcutaneous electrical nerve stimulation (TENS) applied on thoracic region and transcutaneous vagus nerve stimulation (tVNS) are simple and non-invasive treatment to improve upper limb motor function and cognitive function. However, no existing studies have explored on the effects of TENS and tVNS on cognitive function in people with stroke. Therefore, the purpose of this study is to evaluate the effectiveness of TENS on improving upper limb function and cognitive function in people with chronic stroke. Also, this study will investigate the cortical response of people with stroke during TENS by using EEG power spectrum analysis.

This study aims to investigate the effects of three intervention protocols in people with stroke. The participants in Group A will receive TENS on C6 and T5 level of the spine with upper limb exercises. The participants in Group B will receive tVNS on the cymba conchae of left outer ear with upper limb exercises. The participants in Group C will receive placebo tVNS with upper limb exercises.

Eligibility Criteria:
Inclusion Criteria:

1. aged between 50 and 80;
2. have suffered from a single stroke at least 1 year;
3. had volitional control of the non-paretic arm and at least minimal antigravity movement in the paretic shoulder;
4. scored 7 or above in the Abbreviated Mental Test.

Exclusion Criteria:

1. have cardiac pacemaker or cochlear implant;
2. have other neurological diseases;
3. are taking medication that may affect measured outcomes;
4. have skin lesions, infection, or inflammation near selected position;
5. are participating in other drug/treatment programs.
Single-Patient Expanded Access Protocol for Tradipitant In A Single Patient With Gastroparesis

Primary Objective: To treat a single patient with gastroparesis who has requested expanded access with tradipitant

This is a single-patient extended access treatment protocol to be conducted in the United States. Investigator-Physician has determined patient satisfies expanded access inclusion criteria and has requested expanded access to tradipitant.

Patient will be given open label tradipitant 85 mg to be taken twice daily at 12 hour intervals for long term treatment. Patient can fill out daily web-based symptom diaries on a voluntary basis and report any adverse events to Investigator-Physician.

Primary Objective:

-To treat a single patient with gastroparesis who has requested expanded access with tradipitant

Secondary Objectives:

* To monitor the efficacy of tradipitant in reducing individual symptoms associated with gastroparesis in this single patient
* To monitor the safety of tradipitant in a patient with gastroparesis by assessing adverse events in this single patient

Eligibility Criteria:
Inclusion Criteria:

* Identified subject who requested expanded access
* Diagnosed with gastroparesis
* Demonstrated delayed gastric emptying
* Presence of moderate to severe nausea
* Patient does not qualify for or does not have access to other clinical trials with tradipitant;

Exclusion Criteria:

* Another active disorder or treatment which could explain or contribute to symptoms of gastroparesis
* A positive test for drugs of abuse at the screening or evaluation visits;
* Exposure to any investigational medication in the past 60 days other than tradipitant
* Gastrectomy, fundoplication, vagotomy, pyloroplasty, bariatric surgery, or gastric stimulation device surgically implanted within the last year
* Any other reason as determined by the Investigator which may lead to an unfavorable risk-benefit ratio to treatment;
Study to Help Understand the Action of the Drug Etanercept for the Adult Patient With Psoriasis

The investigator's laboratory is studying a skin disease known as psoriasis. The purpose of this protocol is to study the action and the effects of Etanercept, on psoriasis. This medication has been studied extensively and has been found to be effective and safe in the treatment of psoriasis. The eligible patient will have 10% of his/her body surface area involved with psoriasis vulgaris. This trial is a phase III study to help understand the action of the drug etanercept, trade name Enbrel, for the adult patient with moderate to severe plaque psoriasis and who is a candidate for internal medications.

The eligible patient will receive the drug Etanercept (Enbrel), and will self inject with Etanercept twice a week for the first 12 weeks. The patient will be taught to self inject the medication at home and will be seen in the clinic weekly, for the first four weeks and then once a month.

During the second 12 weeks of the study, patients will be placed in one of two groups by the drug company participating. One group of patients will be randomized to either continue receiving the medication and will self inject once a week. A second group will be randomized to not receive the medication but will continue to be followed and examined at monthly visits. The drug company will do the randomization or choice of group, and each patient has a one in two chance of being placed in one group or the other.

At the clinic visits, the patient can expect that a physical exam and skin exam will be done. At specific weeks, blood work will be drawn, clinical photography taken and a skin biopsy done. Two types of skin biopsies will be done after local anesthesia has been administered. One is a punch biopsy where a small piece of skin will be taken, the approximate size of a pencil eraser. The second type of skin biopsy is a shave biopsy, where a postage sized piece of skin will be taken.

Eligibility Criteria:
Inclusion Criteria:

* Gender: Male and Female
* Minimum Age: 18
* Maximum Age: 70

Exclusion Criteria:

* Healthy Volunteers
Symbicort Single Inhaler Therapy vs Conventional Best Practice for the Treatment of Persistent Asthma in Adults

This study is intended to extend the knowledge of Symbicort Single Inhaler Therapy into a more general setting in order to assess the real-life impact of introducing this new treatment concept. The study will compare the Symbicort Single Inhaler Therapy concept with a conventional stepwise treatment regimen according to the investigator's judgement in patients who present with symptoms on inhaled glucocorticosteroids (GCS) treatment or who require and are already on treatment with a combination of inhaled and long-acting B2 agonists (LABA).


Eligibility Criteria:
Inclusion Criteria:

* Minimum of 3 months history of asthma, diagnosed according to the American Thoracic Society (ATS) definition (9).
* Prescribed inhaled GCS at a dose of 400μg/day of budesonide (or equivalents)and within the approved label for the relevant drug during the last 3 months prior to Visit 1.
* Either daily maintenance treatment with both inhaled GCS and LABA or daily treatment with inhaled GCS alone (i.e. without LABA)
* A history of suboptimal asthma control the month prior to enrolment as judged by the investigator
* Use of ≥3 inhalations of as needed medication for symptom relief during the last 7 days before enrolment

Exclusion Criteria:

* Previous treatment with Symbicort Single Inhaler;
* Use of any b-blocking agent, including eye-drops and oral GCS as maintenance treatment.
* Known or suspected hypersensitivity to study therapy or excipients.
* A history of smoking ≥ 10 pack years.
* Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to or at Visit 1.
Esophageal Motility Disease Screening in Patient With Suspicion or Diagnosis of IBD

Aims: Prospective evaluation of patients with a suspicion or diagnosis of Inflammatory bowel disease (IBD) to evaluate osophageal motility before and during therapy

Material and methods: The investigators prospectively perform manometry in patients with or with symptoms consistent with IBD. The investigators evaluate esophageal motility with high resolution manometry before, during and after IBD therapy. Clinical data are also collected to find possible correlations. The study do not modify the planned IBD therapy, but observe motility findings.

Oesophageal motility is measured with the high resolution manometry in order to detect pathologic peristaltic amplitude values among patient before and after therapy (mesalazine, steroids, biologicals) compared to the standard values detected among the normal population. Diagnosic intervention like oesophagoduodenoscopy, colonoscopy and stenosis ballon dilation are allowed as are part of the IBD therapy and follow up.

No other interventions are administered to participants during this study.

Eligibility Criteria:
Inclusion Criteria:

* Inflammatory bowel disease
* Suspicion of inflammatory bowel disease

Exclusion Criteria:

* Pregnancy