cyrilzakka/clinical-trials huggingface dataset:
Position of Esophageal Balloon in Patients With Mechanical Ventilation

Transpulmonary pressure is frequently monitored in patients with mechanical ventilation. Right position of the catheter balloon is the key factor in accurate measurement. A simple method for confirming the balloon position will be validate in this study.

Transpulmonary pressure, which is the pressure at the airway opening minus pleural pressure, is frequently monitored in patients with mechanical ventilation. Because pleural pressure is difficult to measure in most clinical situations, esophageal pressure (Pes) is used as a surrogate. Catheter with air balloon is the most commonly used method to measure the Pes. Right position of the balloon is the key factor in accurate measurement of Pes, and the lower third part of esophagus is recommended as the target position of the balloon. The catheter is usually inserted into the stomach first, and then slowly withdrawn into the esophagus after inflation of the balloon. A negative pressure deflection replacing the positive pressure deflection during inspiration generally indicates the balloon's entering into the esophagus. This confirmation method depends on the normal function of diaphragm. However, it may not always be possible to obtain the standard pressure deflections in patients with mechanical ventilation, especially in those with diaphragmatic paralysis.

In present study, the investigators developed a simple method to confirm the balloon position by using a modified SmartcathG esophageal balloon catheter. The objective was to evaluate the validity of this method and to investigate the relationship between the cardiac artifacts of the Pes tracings and the position of the balloon.

Eligibility Criteria:
Inclusion Criteria:

* adult patients receiving invasive mechanical ventilation

Exclusion Criteria:

* age under 18 years old
* esophageal varices
* evidence of active air leak from the lung, including bronchopleural fistula, pneumothorax, pneumomediastinum, or existing chest tube
* history of chronic obstructive pulmonary disease
* history of lung surgery
* pregnancy
* severe coagulopathy
Assessing the Reliability and Validity of 4-meter and 10-meter Walking Test

The 4-meter walk test and 10-meter walk test is currently applied to assess gait speed.These tools are frequently used in clinical trials and were also shown to be reliable measurement methods. There are ocassions where it is not possible to have a long corridor to measure gait speed. It is necessary to have a tool to evaluate gait speed in a small space as 4-meter walk test.

Walking speed is an important aspect of gait and is commonly used as an objective measure of functional mobility in both clinical and research settings. The majority who have suffered a stroke tend to have gait disturbances. Regaining locomotor ability is one of the primary goals in stroke rehabilitation, and it is most commonly measured using changes in self-selected walking speed. Although many of them can walk independently, they do not do so with enough speed and endurance to allow them to perform their activities of daily living prior to stroke. Not only is self-selected walking speed simple, cost effective, reliable, valid, sensitive, and specific, but it is also highly related to the severity of impairment and predicts functional walking status. It is recommended as a "vital sign" of health. Improvements in walking speed of 0.1 m/s or more have been shown to be a predictor of good health. However, decreased walking speed has been related to worse health outcomes and frailty in older people.

The 4-meter walk test (4 MWT) and 10-meter walk test (10 MWT) is currently applied using various timing protocols and distance covered that may affect data interpretation with a standard value, and comparisons among the studies. There are two protocols to measure walking speed, static and flying start. A static start (i.e., record the time used to cover a total walkway or from the start to stop walking) or a flying start (i.e., measured the time while walking in the middle of the walkway).

The aim of this study is to investigate the test-retest reliability of the 4 MWT and 10 MWT and their correlation with 5-repetition sit-to-stand in chronic stroke survivors.

Eligibility Criteria:
Inclusion Criteria:

* All study participants are clinically diagnosed with stroke
* Adult participants, defined as \>18 years of age
* Have preserved cognitive ability: Achieve a score equal to or greater than 25 points on the Montreal Cognitive Assessment test.
* Have the ability to walk on a flat surface of at least 20 meters, with or without aid.

Exclusion Criteria:

* A history of lower extremities injury or surgery
* A history of botulinum injection within 3 months
* A history of inflammatory arthritis
* A history of inflammatory myopathy or peripheral nervous disease
* A history of other neurological disease as a Parkinson, spinal cord etc.
Evaluation of Novel Biomarkers in Early Recognition of Acute Kidney Injury After Orthopedic Operations.

Surgical treatment of hip fracture may be complicated by acute kidney injury. The aim of this study is to investigate whether the investigators can find a better biomarker than creatinine to recognize this problem at an earlier stage.

Extensive orthopedic surgical procedures may have many postoperative complications. One of those, sometimes overlooked, is acute kidney injury. Classically defined by KDIGO criteria as an increase in creatinine concentration, may go by unnoticed due to a late peak in serum concentration of this marker. There is still need for "nephrological troponin" which could easily and with a low margin of doubt identify acute kidney injury.

The investigators have planned a double-center study, in cooperation with the 'Department of Anesthesiology and Intensive Therapy with the Postoperative Subdivision' of the 'Samodzielny Publiczny Szpital Kliniczny im. prof. Adama Grucy CMKP' in Otwock, concentrating on measuring concentration of biomarkers known to indicate acute kidney injury in different situations: Proenkephalin (PENK), Dickkopf-3 (DKK3), circular RNA (circRNA), Liver-type Fatty Acid-binding Protein (L-FABP), Netrin-1, semaphorin 3a, Tissue Inhibitor of Matrix Metalloproteinase-2 (TIMP-2), Insulin-like Growth Factor-binding Protein 7 (IGFBP-7), Retinol-binding Protein-4 (RBP-4) aiming to find a marker, or group of markers that would allow recognition of renal injury at an early stage to help minimize the effect.

Patients aged at least 18 years, with a hip fracture undergoing, either hip alloplasty, or internal fixation, after providing informed consent, will be included. Patients with end stage renal disease will be excluded. Blood and urine samples will be collected at 5 points of time: 1 - after admission to the operating ward, 2 - following surgery, before leaving the operating ward, 3 - on the 1st postoperative day, 4 - on the 2nd postoperative day, 5 - on the 5th postoperative day, or the day the patient leaves hospital, whichever is first. Additionally patients who will be able to cooperate will have a renal resistive index measured using ultrasonography.

Blood collected from patients, not longer than 8 hours after collection will be tested for PENK concentration (Spingotec GmbH, Berlin, Germany), then plasma obtained from this sample after centrifuging will be frozen together with centrifugated samples of urine in -80 degrees Celsius till analysis.

Additionally, if the concentration of PENK is elevated, the same sample will be tested after 8, 12 and 24 hours of staying at room temperature, to define stability of the test from blood sampling till measurement.

30 days after surgery, an attempt to contact the patient or his/her family is going to be made, to check if the patient has developed need for renal replacement therapy or has required hospitalisation due to kidney dysfunction together with a 30 day mortality evaluation.

Eligibility Criteria:
Inclusion Criteria:

* age at least 18 years
* be able to provide informed consent

Exclusion Criteria:

* end stage renal disease
Efficacy and Safety of K-rod Dynamic Stabilization System in the Repair of Lumbar Degenerative Diseases

To conduct a prospective, single-center, self-controlled, clinical trial to verify the efficacy and safety of K-Rod dynamic stability system in the repair of lumbar degenerative diseases following 2 years follow-up, aiming to provide references for clinical treatment of lumbar degenerative diseases.

Posterior internal fixation and fusion systems are still one of the main methods for the treatment of chronic back pain due to intervertebral disc degeneration, but adverse reactions, such as accelerated regression of adjacent segments, are often inevitable during the treatment.

At present, various pedicle screw-based posterior dynamic stability systems of the lumbar spine have become an alternative fusion therapy for lumbar degenerative diseases. Dynamic stability is defined to reduce the loading on the intervertebral disc/articular surfaces, to maintain movement under mechanical load, to limit the abnormal movement of the spinal segment, and to reduce the stress on the bone-screw interface dynamically and stably. An ideal fixation system will be stable enough to maximize the fusion rate without the need for excessive rigidity, as well as to maintain maximum load and physiological posture of the vertebral segment, thereby reducing the horizontal stress of the adjacent segment.

Eligibility Criteria:
Inclusion Criteria:

* Degenerative lumbar spondylolisthesis (degree I)
* Nerve root canal or central spinal canal stenosis
* Accompanying nerve root pain and/or chronic back pain
* 32-76 years old
* Regardless of gender
* All patients or family members signed the informed consent

Exclusion Criteria:

* Systemic infection;
* Poor compliance and inability to complete the trial
Comparison of Steroid, PRP,and PRP Plus Hyaluronic Acid Injection for Rotator Cuff Lesions.

Rotator cuff tear is a common cause of shoulder pain. Steroids, hyaluronic acid (HA), and platelet-rich plasma (PRP) injections are becoming popular for the treatment of chronic rotator cuff partial tear. The investigators plan to evaluate the effect of the new product of PRP combined with HA on the rotator cuff and prove its benefit of pain control and function recovery.

Rotator cuff tear is a common cause of shoulder pain. Steroids, hyaluronic acid (HA), and platelet-rich plasma (PRP) injections are becoming popular for the treatment of chronic rotator cuff partial tear. The investigators plan to evaluate the effect of the new product of PRP combined with HA on the rotator cuff and prove its benefit of pain control and function recovery.

1. Name: Cellular matrix™ PRP-HA
2. Dosage form: Cellular Matrix A-CP-HA Kit (Ref. A-CP-HA-3)
3. Dose(s): 3 mL of platelet-rich plasma (PRP) combined with 2 mL of hyaluronic acid
4. Dosing schedule: one injection. After collecting 6 mL of blood collection and then centrifugation for 5 minutes, the PRP with a platelet concentration 1.5-1.6 times higher than the baseline in blood, deprived of contamination with red and white blood cells, entrapped in a 3D network of HA
5. Mechanism of action: PRP contains rich growth factors and HA could function as bio-scaffold. They have a synergic effect on tissue repair.
6. Pharmacological category: class III medical device

Eligibility Criteria:
Inclusion Criteria:

* A. Shoulder pain for at least 1 months
* B.partial-thickness tear diagnosed by MRI or Echo
* C.age between 20 and 85 years old

Exclusion Criteria:

* A. inflammatory disease, such as rheumatoid arthritis, SLE, etc.
* B. pregnancy
* C. known malignancy
* D. hematologic disease (or hemoglobin \<10 g/dl, platelet \<150.000 ul)
* E. history of shoulder infection
* F. history of shoulder surgery
* G. prior steroid injection for 3 times or more
* H. full-thickness tear
* I. other shoulder problems, such as osteoarthritis, fracture malunion, etc.
* J. subjects who cannot comply with the protocol of study
* K. The shoulder pain area has been treated with PRP for less than 3 months
Phase I Study of MIK665, a Mcl-1 Inhibitor, in Patients With Refractory or Relapsed Lymphoma or Multiple Myeloma

The purpose of this first in human study is to assess safety, tolerability, PK and preliminary clinical activity and to estimate the MTD(s)/RDE(s) of MIK665 (also referred as S64315) as single agent administered intravenously (i.v.) in adult patients with refractory or relapsed lymphoma or multiple myeloma.

The design of this phase I, open label, dose finding study was chosen in order to characterize the safety and tolerability of MIK665 and to determine the Maximal Tolerated Dose(s) (MTD(s)) and/or Recommended Dose(s) for Expansion (RDE(s)).

This study will utilize a Bayesian Hierarchical model to guide dose escalation and estimate the MTD(s) based on the dose-DLT relationship(s) for MIK665 in the indications.

The expansion part of the study will employ an open-label multiple arm design. The purpose of the expansion part is to further assess safety, tolerability, PK, PD and the anti-tumor activity of MIK665 at the selected RDE/s for Multiple Myeloma (MM) and MYC positive Diffuse large B-Cell Lymphoma (DLBCL) identified in the dose-escalation part.

Eligibility Criteria:
Inclusion Criteria

* Age ≥ 18 years.
* Histologically confirmed lymphoma (WHO classification), or confirmed MM (IMWG), that is relapsed and/or refractory.
* Other Inclusion Criteria May Apply.

Exclusion Criteria

* Known history of chronic liver disease
* History of chronic pancreatitis.
* Prior treatment with Mcl-1 inhibitor.
* Other Exclusion Criteria May Apply.
The Effect of Amputation on Spatial Visual Representation in Peripersonal Space

In this study, we wish to find behavioral evidence for the question whether an amputation of the arm can lead to changes in visual perception or motor responses to objects in peripersonal space. We hypothesize that changes in the motor and somatosensory hand-related cortices following amputation might lead to changes in parietal hand-related areas. The consequence of these parietal changes should be reflected behaviorally in reduced perception/attention/responses to hand-related objects in the space ipsilateral to the amputation. We further hypothesize that the use of prosthetics may provide the necessary visual feedback to maintain an intact hand representation and therefore lead to lesser cortical reorganization in both visual and somatosensory cortical areas.

In a recent fMRI study (Makin TR. et al., J. Neurosci. 2007), we found extended cortical representation for a visual stimulus provided that it is presented close to the hand. It is therefore interesting to ask whether changes in the brain following limb amputation might induce changes in the amputees' perception of the body and consequently it's surrounding. In this study, we wish to find behavioral evidence for the question whether an amputation of the arm can lead to changes in visual perception or motor responses to objects in peripersonal space. We hypothesize that changes in the motor and somatosensory hand-related cortices following amputation might lead to changes in parietal hand-related areas. Consequently, we expect to find reduced perception/attention/responses to hand-related objects in the space ipsilateral to the amputation.

In this experiment we plan to employ a paradigm which is inspired by the affordance effect, originally introduced by Tucker and Elice (1998): we will present subjects with brief images of either manipulable or non manipulable objects in either the left or right visual field. The subjects will be required to determine whether the object contains a metal or not, by moving either their left or their right shoulder. We predict that while the control group of normal subjects would show a congruency effect (that is superior performance (faster and more accurate responses) when the responding shoulder is congruent with the position of the objects, the amputees will show spatial biases towards the non-amputated side. This effect should be more prominent for the manipulable objects.

Eligibility Criteria:
Inclusion Criteria:

* Upper limb amputee, amputation above wrist.
Phase II Study to Investigate the Kinetics of the Immune Response Generated by Influenza Virus Vaccine.

The primary objective of this study was to perform a variety of assays on blood, serum, nasal wash and cell samples obtained from healthy adult subjects for the purposes of developing assays for application in the further investigation of immune responses generated by influenza virus vaccine, trivalent, types A \& B, live, cold-adapted (liquid formulation CAIV-T; Wyeth, Marietta, PA).

This was a randomized, open-label, placebo-controlled, outpatient study carried out in healthy adults 18 to \< 65 years of age. The study was designed to evaluate the kinetics of the immune responses generated by each of the study products in order to determine the best sampling time for future studies. Subjects were randomized in a 1:1:1 ratio to receive a single dose of either CAIV-T, inactivated influenza virus vaccine (TIV), or placebo.

Eligibility Criteria:
Inclusion Criteria:

* Subjects had to have been at least 18 years of age and less than 65 years of age at the time informed consent was obtained;
* Women of child-bearing potential had to use reliable methods of hormonal and/or nonhormonal contraception (which includes cervical cap, diaphragm, condoms with spermicide or IUD) during sexual intercourse throughout the entire study period; a negative urine pregnancy test (with detection limit of less than or equal to 25mIU/mL) no more than 24 hours prior to vaccine administration; and agreed to avoid pregnancy during participation in the study. A urine pregnancy test was also conducted at the completion of study participation. Females who were surgically sterile at time of enrollment were not required to undergo pregnancy testing.
* who were determined by medical history, physical examination and clinical judgement to be eligible for the study.
* who provided written informed consent after the nature of the study has been explained;
* who were available for one month duration of the trial (from enrollment to study completion);
* who could be reached by study staff for the post-vaccination contact \[telephone, clinic or home visit\].

Exclusion Criteria:

* who were perceived to be unavailable or difficult to contact for evaluation or study visits during the study period;
* with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids and intranasal steroids; or cytotoxic agents;
* who had an immunosuppressed or an immunocompromised individual living in the same household;
* who had a documented history of hypersensitivity to egg or egg protein or any other component of the study vaccine or placebo;
* who received any commercially-available or investigational injected influenza vaccine in the 6 months prior to enrollment, or a non-study influenza vaccine since enrollment;
* who previously received an intranasally administered influenza vaccine;
* who had any medical conditions that, in the opinion of the investigator, might interfere with interpretation of the study results;
A Study of The Relative Bioavailability of Ritonavir-Boosted Danoprevir Fixed Dose Combination Tablets in Healthy Volunteers

This randomized, open-label, crossover study will evaluate the relative bioavailability of ritonavir-boosted danoprevir fixed dose combination tablets (FDC) as compared to ad hoc combination of reference tablets of danoprevir and ritonavir in healthy volunteers. Subjects will be randomized to 1 of 6 treatment sequences to receive single oral doses of either an FDC of danoprevir and ritonavir or danoprevir and ritonavir as separate tablets. In a crossover design, subjects will participate in 3 study periods with at least a 7-day washout between periods. In Part 2, single dose administration of film-coated FDCs will be compared to reference tablets.


Eligibility Criteria:
Inclusion Criteria:

* Male and female volunteers, 18 to 55 years of age
* Body weight \>/= 50.0 kg
* Body mass index (BMI) 18.0 - 32.0 kg/m2
* Healthy non-smoking subjects. Healthy status will be defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
* Medical history without major, recent, or ongoing pathology
* Females of childbearing potential and males and their female partners of childbearing potential must agree to use 2 forms of contraception, 1 of which must be a barrier method, during the study and for 90 days after the last drug administration

Exclusion Criteria:

* Pregnant or lactating women or males with female partners who are pregnant or lactating
* Any history of clinically significant cardiovascular or cerebrovascular disease, hypertension, and/or infections
* Positive result for drugs of abuse at screening or prior to admission to the clinical site during any study period
* Positive for hepatitis B, hepatitis C or HIV infection
* Current smokers or subjects who have discontinued smoking less than 6 months prior to first dose of study medication
* Use of hormonal contraceptives (e.g. birth control pills, patches, injectable, implantable devices) within 30 days before the first dose of study medication
* Use of an investigational drug or device within 30 days of the first dose of study medication (6 months for biologic therapies) or 5 half-lives of the investigational drug, whichever is longer
* History of drug-related allergic reactions or hepatotoxicity
* History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average