cyrilzakka/clinical-trials huggingface dataset:
Predictive Factors of Response to Somatostatin Analogues in Acromegalic Patients With Persistent Disease Following Surgery

The objective of this study is to evaluate, in acromegalic patients with disease persistence after surgery who are treated with somatostatin analogues, the histopathological, clinical, morphological and biochemical factors which are predictive of hormonal control.


Eligibility Criteria:
Inclusion Criteria:

* Acromegalic patients with persistent disease (growth hormone ≥ 1ng/ml following oral glucose tolerance test and/or insulin like growth factor 1 above the normal range for sex and age) 3 to 6 months after transsphenoidal or transfrontal surgery

Exclusion Criteria:

* Patients not contributing enough material for a tumour histopathological study
* Patients who have received radiation therapy or will receive it during the observational study period
* Patients who are being treated, or in whom treatment is anticipated, with either a dopaminergic agonist or a growth hormone receptor antagonist
* Patients with a history of hypersensitivity to somatostatin analogues
Repetition Improves Precision and Trueness of Digital Intraoral Scans

The objectives of this study were to compare the precision of two digital intraoral scanners from a series of repeat scan images, and to investigate the effect of the learning curve on changes in trueness when scanning the full arch of the oral cavity in actual patients.

Study Participants: This study was approved by the institutional review board of Ehwa Womans University Medical Center Mokdong Hospital, and dental hygienists who were suitable for the purpose of the study were selected (ECT14-02A-27). Participants were assigned one of four patients, and subsequently scanned the oral cavity of a single patient 10 times repeatedly over 4 days.

Study Design: The participants visited the dental clinic and performed scanning for 4 days. In order to investigate the difference in the precision and trueness of two types of intraoral scanners, the participants scanned the dental arch of a single patient 10 times using an assigned digital intraoral scanner. On the first day, either of the two types of scanners (iTero and Trios), and a patient were assigned. Then, the participants were trained in theory and practices of the assigned scanner, and subsequently, using it, scanned the dental arch of the assigned patient twice. On the second and third days, the dental arch of the same patient was scanned 3 times respectively, and on the fourth day, the experiment was finished after scanning the same patient twice.

Statistical Analyses: Collected data were analyzed using the SPSS Ver. 20.0 statistical package. For the determination of differences in the deviations according to the scanner, the independent two-sample t-test was conducted to examine the significance of the precision data. For comparisons of trueness according to repeated learning, the repeated measure ANOVA was used to test for differences between the scanners, clinical experience of the participants, and the scanning region within the same scanner group. The significance of time-dependent changes, and the interaction between the scanner group and time variables, were examined by within-subject tests. Differences between the scanner groups were examined by between-subject tests. The significance of the 10 consecutive scans and four visits within the scanner group, and the difference between the scanner groups at each time point, were examined by the post-hoc test, which was performed using the Bonferroni method as a multiple comparison (α= 0.05).

Eligibility Criteria:
Inclusion Criteria:

* The selection criteria for the participants were as follows: they had the clinical experiences between 3 - 11 years, understood the purpose of the study well, gave their consent, and were able to carry out a 4-day learning course. Those who were inadequate to carry out the study mentally or physically.

Exclusion Criteria:

* Applicant who was considered inappropriate .for this study by the principal investigator was excluded from the selection
Sargramostim for Myeloid Dendritic Cell Deficiency

Previous studies have demonstrated a deficiency of blood dendritic cells in patients with kidney disease that is associated with the development of viral infections after kidney transplantation. We plan to test the ability of sargramostim to increase blood dendritic cell levels in patients with kidney disease in the hopes of developing new therapies to prevent viral infections after kidney transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years \< 80 years with diagnosis of end stage renal disease and currently undergoing outpatient hemodialysis (HD) at one of the Johns Hopkins University-affiliated HD units

Exclusion Criteria:

* Age\<18or\>80years
* History of non-adherence to prescribed HD treatment
* Active drug or heavy alcohol use (defined as \> 4 drinks/day)
* Pregnancy or breast feeding
* Active infection (bacterial or viral) or clinically significant infections within the past three months (e.g. those requiring hospitalization, or as judged by the PI)
* Active malignancy (with the exception of excised non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin, or adequately treated pre- invasive cervical cancer in situ)
* Unstable cardiovascular status (angina, arrhythmias, congestive heart failure etc...)
* History of liver disease (as defined by a diagnosis of uncompensated cirrhosis) • History of lung disease (including moderate-severe chronic obstructive pulmonary disease, interstitial lung disease, or asthma)
* Known hypersensitivity to yeast-derived products
* Hemoglobin \< 10 g/dL and hematocrit \< 30%.
* Abnormal white blood cell (WBC) count at baseline (\< 3 or \> 12 x 10 cells/mm )
* Treatment with WBC growth factors (G-CSF or GM-CSF) or immunosuppressive medications (tacrolimus, cyclosporine, mycophenolate, azathioprine, corticosteroids, chlorambucil, cyclophosphamide) within 4 weeks of study (erythropoiesis-stimulating agents will be allowed)
* Treatment with lithium within 4 weeks of study
Effect of Hepatic Impairment on LDE225..

This study is to evaluate the pharmacokinetics and safety of 800 mg of LDE225 in subjects with impaired hepatic function and healthy subjects with normal hepatic function.


Eligibility Criteria:
Inclusion Criteria (all groups):

* Male and sterile or postmenopausal female age ≥18 to ≤70 years old.
* Normal Vital signs

Inclusion (group mild, moderate and severe hepatic impairment):

-Subjects with confirmed cirrhosis

Exclusion (all groups):

* Woman of childbearing potential and pregnant or lactating females or male not using condom
* Risk factors for torsades de pointes
* Clinically significant cardio-vascular disease
* severe or uncontrolled medical conditions
* Smokers consuming greater than 10 cigarettes or equivalent nicotine containing products per day.
* Use of investigational drugs (i.e. participation in any clinical investigation)

Exclusion for moderate, mild and severe groups:

* Symptoms or history of encephalopathy
* Clinical evidence of severe ascites

Exclusion Criteria:

-
Atherectomy By Laser Ablation With Turbo-Elite

The primary objective for this study is to prove the safety and effectiveness of the Spectranetics Turbo-Elite catheter in atherectomy treatment for infrainguinal arteries with catheter to vessel sizing of at least 50%.


Eligibility Criteria:
Inclusion Criteria:

* PAD with Rutherford Class 1-4
* Patient is able to walk unassisted or with non-motorized assistive devices.
* Documented PAD by ABI \<0.9 or previous intervention with reoccurrence of symptoms
* Documented stenosis by duplex ≥50%

Exclusion Criteria:

* Patient is pregnant or breast feeding.
* Evidence of Acute Limb Ischemia within 7 days prior to procedure.
* CVA \< 60 days prior to procedure.
* MI \< 60 days prior to procedure.
* Known contraindication to aspirin, antiplatelet/anti-coagulant therapies required for procedure/follow up.
* Known allergy to contrast media that cannot adequately be pre-medicated prior to study procedure.
* Uncontrolled hypercoagulability or history of HIT or HITTS syndrome.
* Serum creatinine ≥ 2.5 mg/dL (unless dialysis-dependent) within one day prior to procedure.
* Patient is simultaneously participating in another investigational drug or device study that will interfere with the 30 day Safety Endpoint.
* Previously identified severe calcium in the vessel.
Follow-up of Patients After 4-row Arthrodesis or Proximal Row Carpectomy

The purpose of this trial is to follow-up on patients who underwent different types of wrist surgery: 4-row arthrodesis or proximal row carpectomy.


Eligibility Criteria:
Inclusion Criteria:

* All patients who underwent wrist surgery (4-row arthrodesis or proximal row carpectomy) between 1998 and 2004
Optimized Camera-based Patient Positioning in CT

To evaluate the effect on radiation dose using intelligent camera positioning in comparison to manual positioning by the radiology assistant.

The positioning of the patient at the beginning of every CT examination has an major influence on the image quality and especially on the respective effective patient dose in the CT scan. If the patient position is closer to the X-ray tube, the patient dose increases significantly and if the vertical patient position is chosen too far away from the X-ray tube, the applied dose decreases, but also the image quality.

In a retrospective observational study, patients were examined on the CT scanner Somatom X.Cite and divided into two groups, one group was with intelligent camera positioning and the other with manual positioning.

The patients received their CT scan at the Institute Radiology and Nuclear Medicine at the Nuremberg North Hospital strictly according to the clinical indication and without influence of the study.

Eligibility Criteria:
Inclusion Criteria:

Only patients with a clinical indication for a CT Scan

Exclusion Criteria:

renal insufficiency, manifest hyperthyroidism and pregnancy
Recurrence Rate of Mini-SLET vs. Limbal-Conjunctival Autograft in Primary Pterygium Excision

To study the efficacy and safety of amniotic membrane transplantation as an adjunctive therapy after surgical excision of primary pterygium and compare the clinical outcomes with conjunctival autograft

Prospective Randomized Blind Clinical Trial

Sixty-four eyes of 64 patients with primary nasal pterygium have been operated by two surgeons (E. G-H, A. N-C). All patients are randomized to undergo Mini-SLET or limbal-conjunctival autograft transplantation as an adjuvant therapy after pterygium excision.

Four eyes were treated with Mini-SLET(group 1), and 26 eyes have been operated with conjunctival autograft (group 2). Patients will be followed up at 1 day, 1 week, 1, 3, 6, 9 and 12 months postoperation. The main outcome measurement was a recurrence rate after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary nasal pterygium \> 2mm

Exclusion Criteria:

* Pregnant
* Previous ocular surgery
Reconstructions With Back Donor Site Flaps and Validation of Quality of Life Scales

The latissimus dorsi flap is the oldest and most used technique for breast reconstruction. Nonetheless, there are few studies evaluation the long-term effect of harvesting one of the muscles of the back. This project has four parts.

1. Validation of scales/instrument for Swedish.
2. Long-term results after reconstruction with latissimus dorsi- a ten year retrospective follow-up.
3. Thoracodorsal artery perforator flap (TDAP) vs latissimus dorsi flap- a randomized controlled trial - breast reconstruction.
4. TDAP vs Limber flap - a randomized controlled trial- reconstruction of axillary hidradenitis suppurativa.


Eligibility Criteria:
Inclusion criteria:

* Patients eligible for breast reconstruction following mastectomy and radiation
* Non-smokers or ex-smokers (\>6 weeks)
* BMI \< 30

Exclusion Criteria:

* Inability to leave informed consent
* Inability to understand Swedish
* Previous surgery with scaring on back
Tightrope or Screw Fixation of Acute Tibiofibular Syndesmotic Injury

Syndesmotic injuries are common and often associated with unstable ankle fractures. The most common treatment is with a syndesmotic screw through the fibula and tibia which is later removed, usually after 10-12 weeks. The Tightrope Syndesmosis Repair Kit (Arthrex; Naples, Florida). is used for the same indication, it consists of a heavy suture placed across the syndesmosis which has been looped and tightened through cortical button anchors on either side of the ankle. It does not need removal and thus avoids subsequent surgery. This trial compares these two treatment methods for syndesmotic injuries of the ankle.

Patients 18-70 years presenting to one of the two hospitals with an acute syndesmotic injury are eligible for inclusion. 50 patients are randomised to two treatment groups: One group receives a Tightrope (R) fixation and the other receives a quadricortical screw fixation which is removed after 12 weeks. Follow-up intervals are at 6 weeks, 6, 12 and 24 months with standardised CT scans postoperatively and at 12, 24 months and 5 years clinical end-ponts/scores.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 70 years
* Acute syndesmotic injury with or without Weber type C fracture

Exclusion Criteria:

* Prior injury of the same ankle
* Severe injury of same leg affecting rehabilitation
* Symptomatic osteoarthritis of same ankle
* Open injury
* Decubital injury affecting surgical site
* Dementia or unable to sign informed consent
* Neuropathic conditions affecting same leg
Clinical Trial in China

The purpose of this clinical study is to evaluate the effectiveness and safety of the transcatheter aortic valve system in the treatment of patients with severe aortic regurgitation disease who are at high or prohibitive surgical risk.

This study is a prospective, multicenter, single-arm, clinical study.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 65;
2. Patients with symptomatic aortic valve regurgitation diseases, and New York Heart Association (NYHA) ≥ II;
3. Subject must have Society of Thoracic Surgeons (STS) score ≥8% or have been evaluated as inoperable by the surgical team \[defined as rate of death \>50% within 30 d post-surgery or accompanied with irreversible occasions of other factors prevent surgeries (such as heavily calcified (porcelain) ascending aorta, weakness, chest malformation, liver dysfunction, pulmonary dysfunction and so on ); (Note: age of inoperable patients can be expanded to ≥ 50);
4. Aortic valve anatomy is suitable for TAVR evaluated by the investigators;
5. Patients who can sign informed consent form, and are willing to accept relevant examinations and clinical follow-ups.

Exclusion Criteria:

1. Active endocarditis;
2. Acute myocardial infarction or coronary revascularization occurred within 1 month before procedure;
3. Cerebrovascular accident (CVA) occurred within 30 days before procedure;
4. The echocardiogram indicates the presence of mass, thrombus or vegetation in left ventricle and left atrium;
5. Hypertrophic obstructive cardiomyopathy;
6. Other valve diseases that need interventions;
7. Previous aortic valve implantation (mechanical or biological);
8. Allergic to Nickel-titanium alloys or contrast agents or cattle-originated products;
9. Known allergy or contraindication to all anticoagulation, or anticoagulation can not be used during the TAVR;
10. In presence one of the following (from selection to the day of procedure index):

    a other diseases that may shorten life expectancy to less than 12 months (recurrent or metastatic cancer, congestive heart failure); b drug abuse (such as cocaine, heroin and so on); c planned additional operations that may result in incompliance or data confusion;
11. Stenosis of common carotid artery, internal carotid artery or vertebral artery \>70%;
12. Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) \<20%;
13. Hepatic encephalopathy or acute active hepatitis;
14. Receiving hemodialysis;
15. Bleeding tendency or history of coagulopathy or refuse to receive transfusion;
16. Active gastrointestinal (GI) ulcer or bleeding;
17. Severe dementia;
18. Patients who need emergency surgery for any reason;
19. Patients are participating in other drugs or medical devices clinical trial;
20. Pregnant or plan to be pregnant, or are taking estrogen or estrogen-like drugs (Women suspected of pregnancy must have a negative serum or urine test for human villous gonadotropin prior to enrollment in the study);
21. Other inappropriate occasions according to the investigators.
RELAXaHEAD for Headache Patients (Phase III)

This study is a fully powered, remote randomized control trial to evaluate RELAXaHEAD in people with migraine.

Patients with migraine seen across diverse primary care practices (through three different affiliated hospitals and one of the largest family health center groups in the country) will be identified via an electronic medical record system. The investigators will randomize 356 participants and examine the potential benefits to two different smartphone based interventions between baseline and weeks 3-6. The investigators will also examine the persistence of effects up to 26 weeks post-treatment, mediators to explore mechanisms, and moderators to identify subgroups of patients for whom the intervention seems most effective.

Eligibility Criteria:
Inclusion Criteria:

* English speaking. (At this time, the validated app is only available in English.)
* ≥16 years of age
* Meets International Classification of Headache Disorder (ICHD)-3 migraine criteria based on Information in the Study Manual
* Headaches for ≥1 year with a stable pattern for the past \>3 months
* Agreement to not make any preventive medication changes for the 3 months before the start of the trial and then the 6 weeks of the intervention part of the study
* 4-29 headache days a month (so that we include those in whom we typically offer preventive treatment (\>4 headache days/month and those with more frequent migraines including chronic migraine but exclude those with continuous headaches (30 days/month))
* MSQv2 score \<75 for role restrictive function to ensure participants have sufficient reduced quality of life to potentially benefit from the intervention (see if there is a positive effect of the intervention)

Exclusion Criteria:

* Patients who have had CBT, Biofeedback, or other Relaxation Therapy for migraine in the past year
* Alcohol or other substance abuse as determined by self-report or prior documentation in the medical record
* Diagnosis of medication overuse headache and/or opioid or barbiturate use
* PHQ-8 scores greater than 15, indicate a conservative score of moderately severe depressive symptoms based on the PHQ-9 12-14 (in those with PHQ-8 scores \>15, more intense intervention targeted to the depression may be needed, as depression is a significant predictor of migraine chronification and people with migraine and comorbid depression are more likely to be refractory to migraine treatments and to suffer from medication overuse)
* Unable or unwilling to follow a treatment program that relies on written and audio-taped materials
* Not having a smartphone (we do not believe this exclusion criterion will adversely affect equitable subject selection because the subject population specific to our research question would only be able to access this application via smartphone if it were to become publicly available, including subjects without smartphones would not be pertinent to our research question and overall study goals).
* Pregnant (because hormonal fluctuations in pregnancy can affect migraine outcomes)
The Effect of Health Literacy Education in Adults (HELP-e-Pulse)

The world's elderly population is increasing. It is possible to prepare for the old age period by starting to develop the level of Health Literacy (HL) in the 45-64 age group. In this context, this study is planned to be conducted as a randomized controlled study with an active control group in order to compare the effect of European Health Literacy-based education and e-Pulse education (HELP) on the level of health literacy in adults aged 45-64 with insufficient-limited health literacy. The study was planned to include a total of 140 participants from the intervention group (HELP) (n:70) and the active control group (e-Pulse) (n:70). Interactive group training consisting of six modules and 90 minutes each will be given to the HELP group. Individual e-Pulse instruction will be given to the active control group. European Health Literacy Scale scores will be considered as the primary outcome of the research. Scores from the eHealth Literacy Scale will be considered as the secondary outcome of the research.


Eligibility Criteria:
Inclusion Criteria:

* Being aged 45-64 and above and being literate,
* Having a score of 33 or less on the European Health Literacy Scale (insufficient, limited and problematic health literacy)
* Being able to use a smart phone, tablet or computer,
* Having agreed to voluntarily participate in the study.

Exclusion Criteria:

• Those who do not speak Turkish
Integrated Cognitive, Sensory, and Motor Rehabilitation of Hand Functions

This study evaulates the addition to the standard theraphy of enriched sensorimotor training by means of robotic glove therapy, or functional electrical stimulation in the treatment of chronic stroke patients with upper limb motor impairments. All the patients receive the conventional physiotherapic treatment. Supplemental to the conventional treatment, patients are evenly split in four groups to provide different treatments for an equivalent amount of time. Patient in the first group receive supplemental conventional therapy; patients in the second group receive robotic glove therapy; patients in the third group receive functional electrical stimulation; patients in the fourth group receive robotic glove treatment and functional electrical stimulation in different sessions.

Stroke very frequently impacts on patients' motor function, and particularly on upper limb movements. Limited hand functionality is a major negative outcome after stroke, negatively affecting patients' recovery and independence, with major impact on rehabilitation.However, standard motor rehabilitation outcome is often suboptimal, because insufficient or non-specific treatment is provided. Robotic hand mobilization and functiona electrical stimulation grasp rehabilitation each improve motor capabilities in grasp impaired patients, but they do so by different mechanisms.

Robotic hand mobilization achieves grasp rehabilitation by providing passive mobilization of the affected limb if the subject does not react to the designed task.

Functional electrical stimulation achieves grasp rehabilitation by inducing localized muscle contraction, that is by providing an electrical field able to stimulate both sensory afferent pathways and lower motor neurons in the targeted volume.

Eligibility Criteria:
Inclusion Criteria:

* Adults male and/or female, older than 18 years
* Patients who have suffered one or more strokes with major unilateral functional impairment
* Hemiplegic, left and right unilateral lesion
* Chronic phase of stroke at least six months before study enrollment
* Level of impairment: hand and/or arm
* No left handed
* Mini-Mental State Examination \> 20

Exclusion Criteria:

* Limitation for using the device due to impairment of Passive Range of Motion and/or
* Pain due to Spasticity evaluated using Modified Ashworth Scale (\>=3)
* Previous history of major neurological or psychiatric disorders
* allergy to electrodes