cyrilzakka/clinical-trials huggingface dataset:
Vitamin D Supplementation on in Major Orthopedic Surgery

Prospective, monocentric study in open, aimed at evaluating the effects of supplementation with calcifediol on left ventricular function parameters in cardiopathic subjects undergoing major orthopedic surgery.

Population of the study: 47 cardiopathic patients with hypovitaminosis D supplemented with calcifediol to reach vitamin D levels\> 30 ng / ml within 6 months. The purpose of this study is to evaluate the improvement of the ejection fraction or GLS (global longitudinal strain) calculated by speckle tracking at 6 months in cardiopathic patients with vitamin D deficiency during functional recovery after major orthopedic surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age: \> or equal to 55 years, \< or equal to 85 years
* cardiopathic patients (including hypertension) who must undergo major orthopedic surgery at our site
* patients with diagnosis: hypovitaminosis d

Exclusion Criteria:

* presence of neoplasm
* endocrinological pathologies excluding diabetes mellitus
* advanced chronic renal failure (GFR \< 35 ml/min)
* pregnant women
* impossibility to participate to the rehabilitation protocol or to perform the established controls
Safety and Efficacy Study of AMG 073 in Hemodialysis Subjects

Subjects on Hemodialysis will be randomized to AMG 073 or placebo. The screening period is a maximum of 30 days followed by a 26-week treatment period. Lab assessments will be completed throughout the study along with PRO assessments.


Eligibility Criteria:
Inclusion Criteria:

* Men and Women greater than or equal to 18 years of age
* Using effective contraceptive measures
* Mean iPTH during screening of greater than or equal to 300 pg/mL
* Mean calcium during screening of greater than or equal to 8.4 mg/dL
* Stable on hemodialysis

Exclusion Criteria:

* Unstable medical conditions
* Parathyroidectomy within 3 months
* Change in Vitamin D therapy
* Receiving antidepressants
* Experienced an MI within 3 months
* Inability to swallow tablets
* Previously received AMG 073
Low Level Laser Therapy for Hyposalivation

The aim of this study was to compare the effects of different wave lengths of LLLT on salivation in participants suffering from hyposalivation.

This study included 30 participants whose major salivary glands were treated with low intensity diode laser BTL2000 (Medical Technologies, s.r.o., Czech Republic) during 10 consecutive days. Patients were randomly assigned in two groups, each of 15 patients, and treated with LLLT of 830 nm and LLLT of 685 nm, respectively. The whole unstimulated and stimulated saliva was measured each day during 10 days, before and after laser treatment and 10th day after treatment was ended.

Low level laser treatment has proved to be effective for a wide range of oral pathologies including oral dryness, but the literature still lacks reports of clinical trials and protocols. The aim of this study was to evaluate the effects of two different laser wave lengths on salivation of patients suffering from hyposalivation. This with purpose to possibly find the optimum laser wavelength for the treatment, and to determine the better protocol for the patients suffering from hyposalivation. This study included 30 patients whose major salivary glands were treated with low intensity diode laser BTL2000 (Medical Technologies, s.r.o., Czech Republic) during 10 consecutive days. Patients were randomly assigned in two groups, each of 15 patients, and treated with LLLT of 830 nm and LLLT of 685 nm, respectively. The whole unstimulated and stimulated saliva was measured in graduated tubes each day during 10 days, before and after laser treatment and 10th day after treatment was ended.

Eligibility Criteria:
Inclusion Criteria:

* patients suffering from hyposalivation, with medical histories free of radiotherapy and Sjögren's syndrome

Exclusion Criteria:

* medical histories of radiotherapy and Sjögren's syndrome
Role of Autologous Platelet Rich Plasma(PRP) Injection and Platelet Rich Fibrin Glue(PRFG) Interposition for Treatment of Anal Fistula

To evaluate the autologous platelet rich plasma and platelet rich fibrin glue effect on the treatment of anal fistula

To asses role of platelet rich plasma and platelet rich fibrin glue in decreasing recurrence of perianal fistula

An anal fistula (AF) is a tunnel connecting the anal canal or rectum (internal opening) with the skin (external opening) around the anus. Patients who have a perianal abscess have symptoms include discomfort, trouble sitting, and pus or blood discharge. Simple and complicated anal fistulas are the two types that exist. A complex fistula is difficult to manage, has a higher risk of recurrence rates, and poses a greater threat to continence after surgery. AF was associated with significant morbidity which is a devastating condition with profound effects on both the physical and psychological health of the patient.

Fibrin glue (also called fibrin sealant) is a surgical formulation used to create a fibrin clot for hemostasis, cartilage repair surgeries or wound healing. It contains separately packaged human fibrinogen and human thrombin. New procedures were published in the scientific literature, each with advantages and disadvantages. According to reports, an effective therapy option is the autologous fibrin glue that is rich in platelets.

PRP began to be used in surgery as a regenerative tissue factor

The tract fistula was cleaned with betadine 10% before PRP and PRFP were applied. Then, 2 ml of PRP was injected around the fistula into the tissue (the penetration depth in injection was 5-6 mm), and 4 ml PRFP was mixed with 1 m thrombin and interpositioned into the tract. 2 ml of PRP was injected around the fistula into the tissue (the penetration depth in injection was 5-6 mm), and 4 ml PRFP was mixed with 1 m thrombin and interpositioned into the tract. The operation time was about 20-30 minutes, the clot formation usually takes about 8 minutes, but the anesthesia was extended to 20 minutes to make sure a complete clot in the place of fistula

Eligibility Criteria:
Inclusion Criteria:

* 60 patients with perianal fistula were in the age group between 20 to 60 years old

Exclusion Criteria:

* Thrombocytopenia
* Patient with rectovaginal fistula
* fistula with chronic cavities
* Acute sepsis and patient were not willing undergo this type of treatment
Evaluation of the Safety, Tolerability, Pharmacokinetics (PK) and Effects on Liver Iron Concentration of ICL670 Relative to Deferoxamine(DFO).

The safety, tolerability, effects on liver iron concentration and pharmacokinetics of ICL670 is studied in sickle cell disease patients with transfusional hemosiderosis.

The treatment period started once the patient completed the core study and signed informed consent. It is continued for up to 4 years. Safety parameters were assessed every 4 weeks. Eye and Ear examinations were performed on a yearly basis. To further investigate the extent of iron overload, serum ferritin, iron, and transferrin were monitored every four weeks. The Program Safety Board monitored the safety of ICL670 during the study to evaluate and categorize any serious case reported in association with ICL670.

Eligibility Criteria:
Inclusion Criteria:

Patients were included who met the following criteria:

* Completion of the core \[Study 0109\]
* Serum ferritin greater than or equal to 500 µg/L
* Ability to comply with all study-related procedures, medications, and evaluations
* Sexually active post-menarche female patients must use double-barrier contraception, oral contraceptive plus barrier contraceptive, or must have undergone clinically documented total hysterectomy and/or oophorectomy, tubal ligation or be postmenopausal defined by amenorrhea for at least 12 months.
* Written informed consent and assent by the patient and or their parents or legal guardian.

Additional inclusion criteria for pediatric patients The definition of the term 'pediatric' for enrollment and study conduct was in accordance with local law. Parents or the legal guardians were fully informed by the investigator as to the requirements of the study. The pediatric patients themselves were informed according to their capabilities in a language and terms that they were able to understand. Written informed consent was obtained from their legal guardian on the patient's behalf in accordance with national legislation. If capable, all patients had to also personally sign their written informed consent.

Exclusion Criteria:

Patients who met the following criteria were to be excluded:

* History of non-compliance to medical regimens and patients who are considered potentially unreliable and/or not cooperative
* Serum creatinine above the age-appropriate upper limit of normal within one week prior to entry
* Patients with ALT ≥ 500 U/L within one week prior to entry
* Evidence of chelation-related cataracts or hearing loss within 4 weeks prior to baseline
* Pregnancy (as indicated by serum β-HCG pregnancy test for all female patients with the potential to become pregnant) and patients who are breastfeeding
* Patients treated with systemic investigational drug within 4 weeks prior to or with topical investigational drug within 7 days prior to the baseline visit

Other protocol-defined inclusion/exclusion criteria may apply
Xenon-enhanced Ventilation CT-guided Radiotherapy for Lung Cancer Treatment

The investigators aim to use xenon-enhanced ventilation computed tomography (CT) to design personalized functional lung avoidance radiotherapy for lung cancer patients who are scheduled to receive lung radiation therapy. The investigators' goal is to optimally protect the lung function of the patients and reduce the incidence of radiation pneumonitis.

There has been an increase in the application of radiation therapy in the treatment of lung tumors; however, the associated side effect, called radiation pneumonitis, can significantly reduce lung function and the quality of life of patients, eventually leading to fatal consequences. The investigators aim to use xenon-enhanced ventilation computed tomography (CT) to design personalized functional lung avoidance radiotherapy for lung cancer patients who are scheduled to receive lung radiation therapy. The investigators' goal is to optimally protect the lung function of the patients and reduce the incidence of radiation pneumonitis.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 20-80 years, with lung cancer receiving thoracic radiotherapy in NTUH, from February 2020 to December 2024.

Exclusion Criteria:

* The age is less than 20 years old or older than 80 years old.
* Unstable clinical condition, unable to maintain apnea for 15 second, and history of prior adverse reaction to xenon.
* Renal insufficiency patients.
* Claustrophobia
* Those who are pregnant.
Effectiveness of Intratympanic Dexamethasone With Ligmocaine for Alleviation of Tinnitus

Objective: To determine the effectiveness of Intratympanic dexamethasone with lignocaine in control of idiopathic tinnitus.

Methodology: 264 consenting patients with idiopathic unilateral tinnitus presenting at ENT Department were assessed for tinnitus severity using Modified Tinnitus Handicap Inventory and the scores recorded and subsequently administered intratympanically 2.0 ml (milliliter's) of dexamethasone and lignocaine (1.5 ml dexamethasone + 0.5 ml 1% lignocaine). The dose was repeated twice at weekly intervals. All patients were re assessed on Modified Tinnitus Handicap Inventory two weeks after third Intratympanic administration.


Eligibility Criteria:
Inclusion Criteria:

* score 20 or above on modified tinnitus handicap inventory

Exclusion Criteria:

* head trauma, tympanic membrane perforation, depression, ear surgery
Effect of Doxepin and Nortriptyline on Irritable Bowel Syndrome

The objective of this randomized triple blind controlled trial is to compare the effects of Doxepin and Nortriptyline on diarrhea predominant irritable bowel syndrome. In this stuy, 75 patients with IBS are randomly assigned to receive Doxepin , Nortriptyline or placebo, a tablet per day, orally, for two months. Abdominal pain, mucus in the stool, incomplete evacuation, and bloating are measured and compared between groups at the baseline and one and two month after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Presence of diarrhea predominant irritable bowel syndrome according to ROME criteria

Exclusion Criteria:

* Gastrointestinal bleeding
* More than 5% weight loss in the last 6 months
* Presence of any finding in favor of organic disorders in the lab tests or organic disorder in colonoscopy of high risk patients
Erythropoietin Resistance in Anemia of Chronic Kidney Disease

Our goal of this pilot project is to identify inflammatory biomarkers that correlate with epo-resistance among CKD patients.


Eligibility Criteria:
Inclusion Criteria:

* prevalent patients greater than or equal to 18 years old with CKD defined as a glomerular filtration rate \< 60 cc/min

Exclusion Criteria:

* active GI bleeding or history of GI bleed in the prior 3 months
* uncontrolled hyperparathyroidism (PTH\>500)
* untreated iron deficiency (transferrin saturation \< 20% and ferritin \< 100
* overt infection
* active hemolysis
* hemoglobinopathies
* known adverse response to erythropoietin
* prior kidney transplant
* aluminum toxicity
12-Month, Open-Label, Extension Study of LCP-AtorFen in Dyslipidemia

The current study is designed to test the long-term (12-month) safety and efficacy of LCP-AtorFen, a combination of atorvastatin and fenofibrate, in patients with dyslipidemia

POPULATION:

Subjects with mixed dyslipidemia (non-HDL cholesterol \> 130 mg/dL and TG ≥ 150 mg/dL and ≤ 500 mg/dL) who completed the double-blind study (LCP-AtorFen-2001; NCT00504829), met the enrollment criteria (all of the inclusion criteria and none of the exclusion criteria), and elected to enter the open-label extension study.

STUDY DESIGN AND DURATION:

This is a 52-week, open-label, single-treatment arm with 8 visits (Weeks 0, 4, 8, 12, 24, 36, 48 and 52). A maximum of approximately 200 subjects will enter this open-label safety and efficacy extension study from the LCP AtorFen-2001 double-blind study. All subjects enrolled in this study will receive open-label LCP-AtorFen combination therapy. Visit 1 of the extension study corresponds to the last visit of the double-blind study (Visit 6 or Week 12).

Eligibility Criteria:
Inclusion Criteria:

1. Subject has successfully completed the double-blind study (LCP-AtorFen-2001; NCT00504829).
2. Subject has confirmed his or her willingness to participate in this study after being informed of all aspects of the study by voluntarily signing and dating an informed consent form in accordance with Good Clinical Practice (GCP).

Exclusion Criteria:

1. Study drug compliance \<70% in the double-blind study.
2. Any ongoing serious adverse event, or any ongoing non-serious moderate or severe adverse event from the double-blind study that is rated as possibly, probably or definitely related to study drug.
3. Resting blood pressure \>/=160 mm Hg systolic and/or \>/=100 mm Hg diastolic.
4. Symptoms of unexplained muscle pain, tenderness or weakness (i.e., signs indicative of possible myopathy), or any diagnosis of myopathy or rhabdomyolysis.
5. Any clinically significant change in physical exam or electrocardiogram from Visit 2 to Visit 6 of the double-blind study.
6. Any clinically significant change from Visit 1 to Visit 6 of the double-blind study in medical history including, but not limited to: a diagnosis of insulin-dependent diabetes mellitus (DM); poorly controlled DM; poorly controlled hypertension; significant renal, pulmonary, hepatic, biliary, or gastrointestinal disease; cancer (except non-melanoma skin cancer); and epilepsy.
7. Unwilling to abstain from medications, supplements, ingredients and herbal therapies that were excluded in the double-blind study and continue to be excluded in the open-label study.
8. Women who are pregnant, planning to be pregnant during the study period, lactating, or women of childbearing potential (not surgically sterilized between menarche and menopause) who are not using a medically approved method of contraception.
9. Other exclusion conditions might apply.
Effect of Airseal System Valve-less Trocar on the Ventilatory Parameters During Robotic-assisted Radical Cystectomy

The aim of the investigators' study is to investigate if the use of the AirSeal insufflation system impairs ventilatory parameters of patients less than a conventional system in patients undergoing robot-assisted laparoscopic cystectomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for robotic-assisted Radical Cystectomy
* Written informed consent
* - ≥ 18 years of age

Exclusion Criteria:

* Patients who refuse participating in the study
* ejection fraction \< 40%
* history of retinal vascular occlusion and ischaemic optic neuropathy
Is There Any Relation Between Pain and Stone Location in Retrograde Intrarenal Surgery?

We want to serach the relationship between the pain degree and stone localisation in kidney in Retrograde intrarenal surgery


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing RIRS Age between 18 and 90 years

Exclusion Criteria:

* Patients who have congenital urogenital abnormalities 2)Patients who have previous surgery history
Effects of Different Area of Internal Limiting Membrane Peeling (ILM) Peeling on Anatomical Outcomes in Macular Hole Surgery

The purpose of this study is to determine the effects of two different internal limiting membrane (ILM) peeling area on anatomical closure outcomes after macular hole surgery measured by optical coherence tomography (OCT).


Eligibility Criteria:
Inclusion Criteria:

* patients with IMH
* patients signed the informed consent form (ICF)
* patients with course of IMH less than 3 years

Exclusion Criteria:

* patients with hyper myopia
* patients with traumatic macular hole
* accompanied or secondary of other fundus disease
* open or reopen after receiving MH surgery
* patients with retinal detachment
* received vitrectomy due to other diseases
* glaucoma cannot be controled by medication
* patients with other retinal or choroidal disease that may affect VA
* poor patients compliance
* poor condition that cannot undertake the surgery
* dioptric media opacities which make it difficult to exam fundus or measure on OCT
Long Term Follow up of Toe-to-hand Transfers

Toe transfers are perceived to have changed the landscape of the injured hand over the last half century, yet there are limited validated data that unequivocally support the functional role of toe transfers after traumatic digital amputation. There also remain unanswered questions about what factors critically influence functional outcomes, be it sensory recovery, grip strength or other modality. Furthermore, the use of validated patient reported outcome measures (PROMs) in large series of toe transfers with long term follow up, is lacking.

Finger amputations are associated with profound impacts on physical, socio-economic, vocational and mental well-being. Thumb amputations account for the greatest burden of disability globally amongst hand trauma.

The multi-centre FRANCHISE study and a recent large prospective multi-centre study have demonstrated that finger replantation outperforms equivalent amputations in nearly all digits at all levels, except for the little finger. However, one crucial question in hand surgery is whether toe transfers can provide a similar functional benefit to replantation.

Finger amputations are frequently not replantable even with timely access to specialized reconstructive care. A review of replantation in the USA found that of 3,417 digital amputations, only 631 replantations were attempted (18%), and of these 30% failed. Therefore nearly 90% of patients with finger amputations will ultimately live without the amputated digit.

Microvascular toe-to-hand transfer, first described in the 1960s, has a success rate close to 100% in high volume centres. There are few validated data that support the functional benefits of toe transfer, with the majority of outcome studies focusing on operative survival rates, physical measurements such as grip strength, or employ unvalidated scales and self-created questionnaires. More data, in larger more representative populations, using validated PROMs, is required.

Here, we aim to demonstrate using PROMS that the role of toe transfers has equivalent or improved functional benefits, with comparison to finger replantation. Additionally, this study aims to identify physical factors that have the greatest influence on patient reported outcomes. This may answer fundamental questions regarding optimum strategies for the design of toe transfers.

Eligibility Criteria:
Inclusion Criteria:

* Toe transfers
* minimum 5 year follow up

Exclusion Criteria:

* partial toe transfers including toenail, toe pulp or vascularised joint
* under 5 year follow up
A Clinical Evaluation of an Esterified Hyaluronic Acid Matrix in Burn Patients for STSG

Burn patients meeting inclusion criteria will receive the esterified hyaluronic acid matrix as the matrix for their wound, in conjunction with the standard of care for managing these types of wounds. The study will be divided into two phases. Phase I will entail intervention with the wound matrix and will continue until one of the following occur, sufficient granulation has occurred and the patient can receive a STSG and proceed to Phase II, the patient's physician determines an STSG is no longer necessary or two applications with the wound matrix occur and no STSG is approved. Phase II will begin following the STSG procedure. In this phase, the wound will be monitored and proportion of STSG take will be evaluated but no application of the wound matrix device will take place. This phase will continue for 28 days or if the physician deems the patient no longer needs regular care to monitor the wound, whichever occurs earlier.


Eligibility Criteria:
Inclusion Criteria:

* Has a wound originating from a thermal or electrical burn
* Target burn area is less than 20% of TBSA
* Target burn wound is greater than 0.5% of TBSA
* Patient has undergone escharectomy procedure or will undergo escharectomy on the target burn and resulting wound will likely need a split thickness skin graft, but wound site is not immediately ready for grafting
* For patients with diabetes, an A1C hemoglobin level between 11 percent (taken within 90 days)

Exclusion Criteria:

* Current active diagnosis of substance abuse, per the Investigator
* Patient currently taking non-inhaled corticosteroids
* Patient needs or is likely to need negative pressure wound therapy of the target wound after application of Hyalomatrix Wound Device
* Patient is pregnant, planning to become pregnant during study period, or breastfeeding
* Unstable medical condition as determined by the site investigator
* Patients with known sensitivities to hyaluronan, hyaluronan derivatives, silicone, or any other ingredients of the Hyalomatrix Wound Device