cyrilzakka/clinical-trials huggingface dataset:
A Trial Comparing the Efficacy, Patient-reported Outcomes and Safety of Insulin Degludec 200 U/mL vs Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Requiring High-dose Insulin

This trial is conducted in the United States of America (USA). The aim of the trial is to confirm the efficacy of IDeg (insulin degludec) versus IGlar (insulin glargine) in controlling glycaemia. Subjects are to continue their pre-trial metformin treatment.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Current treatment with once daily insulin glargine in vials with a daily dose equal to or above 65 U and equal to or below 100 U
* Current treatment with a stable dose of metformin plus/minus one additional oral antidiabetic drug (OAD) for at least 12 weeks
* Glycosylated haemoglobin (HbA1c) equal to or above 7.5%

Exclusion Criteria:

* Current treatment with insulin other than insulin glargine in vials
* Treatment with thiazolidinediones or glucagon-like peptide-1 (GLP-1) receptor agonists within 12 weeks
* Stroke; heart failure; myocardial infarction; unstable angina pectoris; coronary arterial bypass graft or angioplasty
* Suffer from cancer (except basal cell skin cancer and squamous-cell cancer)
Use of Tendon Vibration and Mirror for the Improvement of Upper Limb Function and Pain Reduction

Upper limb paralysis following stroke is a very common problem. Only 30% of stroke patients who suffer from upper limb paresis experience a full recovery of function. There is a need for the development of more efficient rehabilitation methods for the improvement of the paralysed upper limb function.

It has been shown that the use of mirror therapy after a stroke induces the activation of motor, sensory and associative regions in the affected hemisphere and is associated with an improvement in the function of the affected limb. Mirror therapy is a treatment modality in which the affected arm is hidden from the patient's sight; the patient is instructed to watch the reflection of his healthy hand on a mirror while he performs movements with his healthy hand and tries to move simultaneously his affected hand. This induces the illusion that his affected hand moves well.

It has also been shown that applying vibration to a muscle tendon at frequencies between 50-100 Hz induces an illusion of elongation of the vibrated muscle, if visual feedback is prevented. For instance, vibrating the triceps will induce a strong illusion of elbow flexion.

In the present study the investigators will couple the use of a mirror with the application of vibration to tendons, in order to obtain a multisensorial and strong illusion of movement in the paralyzed limb.

The study hypothesis is that the administration of mirror therapy together with vibration will induce the activation of multiple motor, sensory and associative areas in the affected brain hemisphere, resulting in improvement of the affected upper limb function, compared to the administration of mirror therapy alone or sham therapy.


Eligibility Criteria:
Inclusion Criteria:

* Stroke onset 1 month-1 year ago
* NIH Stroke Scale 3-15 on admission to study
* Affected Upper limb function 10-90% on Fugl-Meyer scale
* Ability to understand instructions and to move freely the unaffected upper limb

Exclusion Criteria:

* Severe cognitive impairment- severe Aphasia or severe Neglect that impair ability to understand instructions or to execute tasks
Nutritional Enhancement in Chronic Obstructive Pulmonary Disease (COPD)

Chronic obstructive pulmonary disease (COPD) is characterized by increased oxidative stress which aggravates airway and systemic inflammation. Previous studies suggested that dietary factors such as ample consumption of antioxidants might have beneficial effects in lung function in COPD patients.

The investigators' primary aim is therefore to investigate prospectively whether a nutritional intervention consisted of diet rich in antioxidants such as fresh fruits and vegetables, would significantly affect lung function decline in COPD patients compared to a free diet.

Methods: This is a 3-year prospective study, incorporating a run-in period of six months and outpatient clinic visits, scheduled every 6 months. Consecutive sampling was used to recruit 120 patients with COPD. At baseline and at each visit all patients were evaluated for respiratory symptoms, dietary habits, medication used and pulmonary function. Patients will be randomized either to a diet based on increased consumption of foods containing antioxidants (fresh fruits and vegetables), intervention group (IG) or, to a free diet, control group (CG).

The investigators hypothesize that the results from the study will suggest that a diet rich in antioxidants may be associated with improvement in lung function in COPD patients. In this respect dietary interventions should be considered in the management of COPD.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD according to the GOLD definition\*
* Ability to perform spirometry.

(\*Pauwels RA, Buist AS, Calverley PM, et al. Global strategy for the diagnosis, management and prevention of Chronic Obstructive Pulmonary disease. NHLBI/WHO Global initiative for Chronic Obstructive Lung Disease (GOLD). Workshop summary. Am J Respir Crit Care Med 2001; 163(5):1256-1276.)

Exclusion Criteria:

* A history of lung cancer, bronchial asthma or other respiratory disease
* Continuous use of systemic steroids more than 30 days prior was used as exclusion criteria
Study of Sacituzumab Govitecan Combinations in First-line Treatment of Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC)

The goal of this clinical study is to learn more about the study drug, sacituzumab govitecan-hziy (SG), and its dosing in combination with pembrolizumab or pembrolizumab and a platinum agent (carboplatin or cisplatin), in participants with advanced or metastatic (cancer that has spread) non-small-cell lung cancer (NSCLC).


Eligibility Criteria:
Key Inclusion Criteria:

* Individuals with pathologically documented evidence of Stage IV non-small cell lung Cancer (NSCLC) disease at the time of enrollment
* Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per RECIST Version 1.1 criteria by investigator
* No prior systemic treatment for metastatic NSCLC
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
* Adequate hematologic counts
* Adequate hepatic function

Key Exclusion Criteria:

* Mixed SCLC and NSCLC histology
* Active second malignancy
* NSCLC that is eligible for definitive local therapy alone
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
* Has an active autoimmune disease that has required systemic treatment in past 2 years
* Has had an allogenic tissue/solid organ transplant.
* Has severe (≥ Grade 3) hypersensitivity to SG, pembrolizumab, carboplatin, or cisplatin, their metabolites, or formulation excipient
* Has received radiation therapy to the lung
* Individuals may not have received systemic anticancer treatment within the previous 6 months
* Is currently participating in or has participated in a study of an investigational agent
* Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
* Known active central nervous system (CNS) metastases
* History of cardiac disease
* Active chronic inflammatory bowel disease
* Active serious infection requiring antibiotics
* Active or chronic hepatitis B infection
* Positive hepatitis C antibody
* Positive serum pregnancy test or women who are lactating

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Optimizing Care for Older Adults Through Thyroid Hormone Deprescribing

The proposed study focuses on testing a novel adapted evidence-based multilevel intervention, Deprescribing Thyroid Hormone In Older Adults (D-THIO), to support thyroid hormone deprescribing (dose de-escalation and/or discontinuation) in older adults with thyroid hormone overtreatment and/or misuse and reduce patient harm. Findings from this study will lay the groundwork for broad implementation of D-THIO and serve as a model for deprescribing inappropriate medications for other endocrine conditions and conditions with biochemical monitoring.

The proposed study is the first multi-site trial to evaluate a novel evidence-based adapted multilevel intervention, D-THIO (Deprescribing Thyroid Hormone In Older Adults), consisting of evidence-based pharmaceutical opinion to providers, education brochures to patients and facilitated by clinical champions, to support thyroid hormone deprescribing in older adults. We will conduct a type 1 hybrid effectiveness-implementation trial of D-THIO vs. enhanced usual care (American Thyroid Association \[ATA\] provider abbreviated guidelines, ATA patient brochure) at 3 sites (University of Michigan, Henry Ford, University of California San Francisco) in 150 providers (primary care, endocrinologists, geriatricians, advance practice providers) and 750 of their patients 65 years and older who are overtreated with thyroid hormone. We will randomize 1:1 at the provider level within each site. The aims of the study are: 1) to assess the effectiveness of D-THIO on thyroid hormone deprescribing by providers and on reducing overtreatment and misuse with thyroid hormone via EMR, 2) to assess the effectiveness of D-THIO on provider and patient knowledge and attitudes regarding thyroid hormone deprescribing via surveys, and 3) to identify factors related to the implementation of D-THIO across diverse general care settings via post-trial interviews with key stakeholders.

Eligibility Criteria:
Patient Eligibility:

Inclusion Criteria:

1. age 65 years and older
2. on thyroid hormone therapy and have a serum Thyroid-stimulating hormone (TSH) \<0.5 mIU/L or are on thyroid hormone therapy for an inappropriate indication
3. English speaking
4. without cognitive impairment

Exclusion Criteria:

1) Patients with a diagnosis of thyroid cancer, secondary hypothyroidism, history of total thyroidectomy or hospitalization in the past 3 months will be excluded.

Provider eligibility:

Inclusion: Primary care physicians, endocrinologists, geriatricians, and Advanced Practice Providers (APPs) who practice at University of Michigan, Henry Ford Health System or University of California San Fransico (UCSF) and who prescribe thyroid hormone for eligible patients identified above will be eligible for study participation.

Exclusion: Providers who don't prescribe thyroid hormone.
Interexaminer Reliability, Outcomes for Manipulation of Cervical Dysfunction, 3-D Kinematics

The purpose of this project is to quantify 3-dimensional (3-D) cervical motion pattern changes that result from osteopathic manipulation treatment (OMT) in an experimental subject group diagnosed with somatic dysfunction. The kinematic data will include the entire 3-D motion trajectories of the head, resulting in range of motion (ROM) and angular data for the primary and secondary motions.

Our primary hypothesis is that kinematic changes will be detected after OMT for motions in the primary direction of the passive diagnostic test motions (cervical side-bending right and left), as well as angular rotations (deviations) occurring around these motions. Our secondary hypothesis is that examination of the kinematic data will provide objective inter- and intra-examiner data to assess similarities/differences occurring during the passive clinical exam before and after OMT. Lastly, we hypothesize that significant differences in the kinematic patterns will result between the two subject groups.

This experiment is designed for the following clinical and biomechanical observations:

* comparisons of diagnostic data between three osteopathic physicians,
* comparisons of within-subject kinematic profiles pre- and post-treatment,
* inter-examiner comparisons of kinematic motion paths occurring during diagnostic motions,
* evaluate kinematic patterns between the two subject groups, and assess between group similarities/differences,
* evaluate diagnostic and kinematic data relative to VAS, cervical disability, health status information, and SNF,
* re-classify aspects of the kinematic data using a cluster (statistical) analysis procedure to compare with initial and secondary physician diagnostic data, and
* to assess the stability of changes made by the OMT procedures and the kinematic response three days post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Cervical motion symmetry and asymmetry

Exclusion Criteria:

* Under 18 years of age
A Post-Market Clinical Performance and Safety Evaluation of GamCath HighFlow Dolphin Protect Catheter

The goal of this retrospective chart review is to obtain clinical safety and performance data for the GamCath HighFlow Dolphin Protect Catheter in patients with acute kidney injury, acute renal failure, or chronic kidney disease.

The main questions to answer are:

1. Duration of catheter use (survival)
2. Reason(s) for catheter removal

The objective of this retrospective chart review is to obtain clinical safety and performance data for the GamCath HighFlow Dolphin Protect Catheter related to the duration of use (catheter survival) throughout its lifetime.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age at the time of catheter insertion.
* Patients diagnosed with AKI, ARF, and/or CKD (including end-stage renal disease \[ESRD\]).
* Patients who required vascular access to perform extracorporeal blood purification using GamCath HighFlow Dolphin Protect Catheter inserted by a physician in the subclavian, jugular, or femoral veins.

Exclusion Criteria:

* Patients who required the GamCath HighFlow Dolphin Protect Catheter for any indication other than extracorporeal blood purification.
* Patients who had a local infection at the vascular access site prior to catheter insertion.
* Patients who required surgical intervention (e.g., cutdown procedure) for GamCath HighFlow Dolphin Protect Catheter placement.
* Patients who had a prior catheter in place at the same vascular access site (i.e., R/L jugular vein, R/L femoral vein, R/L subclavian vein) within the last 7 days.
* Patients who do not have complete patient records to support the primary endpoint analyses.
Safety and Efficacy of Acupressure Applied Through ForgTin© in Patients With Tinnitus

The main objective of this clinical trial is to evaluate the effectiveness and safety of the medical product ForgTin with regard to the impairment and change in the sensation of tinnitus (volume, frequency, psychological stress).


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients (aged \> 18 years)
* Subjective tinnitus in one or both ears with intermittent or continuous symptoms with a duration of \> 6 months
* Tinnitus of Grade II, III or IV according to Mini-Tinnitus-Questionnaire (Mini-TF12):

  * Grade II (score of 8-12): moderately distressed
  * Grade III (score of 13-18): severely distressed
  * Grade III (score of 19-24): most severely distressed
* If a drug therapy with psychoactive substances (e.g. antidepressants, anticonvulsants) exists at the beginning of the therapeutic intervention, it must have been stable for at least 30 days. The therapy should remain constant during the duration of the study, but a necessary change is not an exclusion criterion. Any change in medication is documented in the CRF.
* Provides written informed consent

Exclusion Criteria:

* Vestibular schwannoma (acoustic neuroma)
* Objective tinnitus
* Any other tinnitus-related treatment
* Ménière's Disease
* Acute infections of the hearing system (acute otitis media, otitis externa, acute sinusitis)
* Acute infections (acute otitis media, otitis externa, acute sinusitis)
* Hearing aids or Cochlear Implants (CI)
* Any current treatment with anticonvulsants, cortisone, tricyclic antidepressants
* Other lesions (glomus tumors, meningiomas, adenomas, vascular lesions or neuro-vascular conflicts) detected by clinical assessment
* Serious, concomitant disorder, including major depression, anxiety
* Any condition that, in the judgment of the investigator, might prevent safe participation in the study or interfere with study objectives
* Inability to comply with the protocol requirements
Fludarabine Based Conditioning for Allogeneic Transplantation for Advanced Hematologic Malignancies

New conditioning regimens are still needed to maximize efficacy and limit treatment-related deaths of allogeneic transplantation for advanced hematologic malignancies. Over the past several years, the investigators have evaluated several new conditioning regimens that incorporate fludarabine, a novel immunosuppressant that has limited toxicity and that has synergistic activity with alkylating agents. Recent data have suggested that fludarabine may be used in combination with standard doses of oral or IV busulfan, thus reducing the toxicity previously observed with cyclophosphamide/ busulfan regimens.

Treatment-related mortality and recurrence of disease account for the majority of treatment failures in allogeneic transplantation for advanced hematologic malignancies. The most commonly utilized conditioning regimens consist of cyclophosphamide and total-body irradiation or busulfan and cyclophosphamide. Other agents such as etoposide or thiotepa are sometimes added to maximize the antileukemic effect. New conditioning regimens are however still needed to maximize efficacy and limit treatment-related deaths. Over the past several years, the investigators have evaluated several new conditioning regimens that incorporate fludarabine, a novel immunosuppressant that has limited toxicity and that has synergistic activity with alkylating agents. Recent data have suggested that fludarabine may be used in combination with standard doses of oral or IV busulfan, thus reducing the toxicity previously observed with cyclophosphamide/ busulfan regimens.

Eligibility Criteria:
Inclusion Criteria:

* Patients with the following diseases:

  * Acute myeloid or lymphocytic leukemia in first remission at standard or high-risk for recurrence.
  * Acute leukemia in greater than or equal to second remission, or with early relapse, or partial remission.
  * Chronic myelogenous leukemia in accelerated phase or blast-crisis.
  * Chronic myelogenous leukemia in chronic phase
  * Recurrent or refractory malignant lymphoma or Hodgkin's disease
  * Multiple myeloma.
  * Chronic lymphocytic leukemia, relapsed or with poor prognostic features.
  * Myeloproliferative disorder (polycythemia vera, myelofibrosis) with poor prognostic features.
  * Severe aplastic anemia after failure of immunosuppressive therapy.
* Age 10-65 years.
* Zubrod performance status less than or equal to 2.
* Adequate cardiac and pulmonary function. Patients with decreased LVEF \< 40% or DLCO \< 50% of predicted will be evaluated by cardiology or pulmonary prior to enrollment on this protocol.
* Patient or guardian able to sign informed consent.

Exclusion Criteria:

* Life expectancy is severely limited by concomitant illness.
* Serum creatinine greater than 1.5 mg/dL or Creatinine Clearance less than 50 ml/min .
* Serum bilirubin greater than or equal to 2.0 mg/dl, SGPT greater than 3 x upper limit of normal
* Evidence of chronic active hepatitis or cirrhosis
* HIV-positive
* Patient is pregnant
Adequate Insertion Depth of Dilator During Central Venous Catheterization

For safe central catheterization, clinicians must be aware of adequate dilator insertion depth not to directly dilate the venous wall. The purpose of the study is to find out adequate insertion depth of the dilator during central venous catheterization through the internal jugular vein with the aid of real-time ultrasonography.

This randomized controlled trial is to compare the distance between the skin puncture site and the outside of anterior wall of the internal jugular vein measured by real-time ultrasonography with the conventional method which is routinely used in common clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* adult patients requiring central venous catheterization through the right internal jugular vein

Exclusion Criteria:

* suspicion for infection of the right neck site
Tube Tip Position in Orally Intubated 0-4year Old Children: Assessment of the Precision of Two Clinical Techniques

In pediatric anesthesia it is very important to place the endotracheal tube into the right position. This study compares two clinical location methods. The hypothesis means that the two techniques have the same precision of the location of the tip position of a cuffed MICROCUFF (Kimberly-Clark)endotracheal tube.

Appropriate location of the tip of an endotracheal tube (TET), in relation to the carina and vocal cords, is of great importance in pediatric anesthesia. A not optimal laying tube causes life threatening consequences. Therefore, it is very essential to have reliable methods how to place the tube tip in regard of the precision of the localisation. There are no standardized methods how to accomplish a precise position. The study compares two most applied techniques. The first one is the cuff palpation technique (CPT), the second one the deliberate right mainstem intubation technique (RMT).

Eligibility Criteria:
Inclusion Criteria:

* Age 0-4 years
* ASA I-II
* requiring endotracheal tube for surgical/diagnostic procedures

Exclusion Criteria:

* patients with abnormal airway anatomy
* kyphoscoliosis
* syndromes known to affect airway anatomy
Pharmacokinetic Pilot Study on Budesonide/Formoterol

The aim of the study is to assess and compare the Pharmacokinetic (PK) of Budesonide and Formoterol after administration of 3 different product variants of Budesonide/Formoterol Easyhalers and Symbicort turbuhaler.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females, 18-55 years of age.
* Normal weight at least 50 kg.

Exclusion Criteria:

* Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
* Any condition requiring concomitant treatment (including vitamins and herbal products)or likely to need any concomitant treatment during the study
* Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of test results or cause a health risk for the subject if he/she participates in the study.
* Known hypersensitivity to the active substance(s) or to any of the excipients of the drug.
* Pregnant or lactating females.