cyrilzakka/clinical-trials huggingface dataset:
Soft Tissue Evaluation Around Implants Using Prf or a Palatal Pedicle

Clinical Evaluation of Peri-Implant Soft Tissue Around Immediately Placed Implants Using PRF Membrane Versus The Palatal Pedicle Soft Tissue Graft: A Randomized Controlled Clinical Trial.

Immediate implant will be place and followed by soft tissue augmentation by PRF or palatal pedicle and the primary outcome is the pink esthetic score

Eligibility Criteria:
Inclusion criteria

1. Absence of periodontal disease or a periapical infection
2. Adequate native bone to achieve implant primary stability
3. The need for a single-tooth replacement in the anterior maxilla (from the second bicuspid to the second bicuspid), subsequent to an inevitable tooth extraction.

Exclusion criteria

1. Systemic conditions/disease that contraindicated surgery
2. Radiation therapy in the head and neck region or chemotherapy during the 12 months prior to surgery.
3. Patients who have any habits that might jeopardize the osseointegration process, such as current smokers.
4. Patients with parafunctional habits that produce overload on implant, such as bruxism and clenching.
5. Patients who have inadequate interarch space for the prosthetic part.
A Randomized Study to Evaluate the Effects of CTP-543 on the QT/QTc Intervals in Health Volunteers

This is a four-arm, randomized, crossover, placebo and active controlled study to evaluate of the effect of therapeutic and supratherapeutic doses of CTP-543 on the QT/QTc intervals in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-smoking, adult males or females aged 18-60
* Body mass index of 18 to 32 mg/m2 at Screening
* Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or Electrocardiograms (ECGs)
* If of reproductive age, willing and able to use a medically highly effective form of birth control 30 days prior to first dose, during the study and for 30 days following last dose of study medication
* Understands the study procedures in the informed consent form and be willing and able to comply with the protocol

Exclusion Criteria:

* History or presence of clinically significant medical or psychiatric condition or disease
* History of any illness that might confound the results of the study or poses an additional risk to the subject by their participation in the study
* History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing
* History of prolonged QT syndrome or a Corrected QT-interval (QTc) with Fridericia's correction (QTcF) \> 450 msec for males or QTcF \> 470 msec for females obtained at Screening visit or prior to the first dosing
* Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug
* Positive results at Screening for human immunodeficiency virus, hepatitis B surface antigen or hepatitis C virus
* A positive test or history of incompletely treated or untreated tuberculosis
Detection of miRNAs in HPA Axis Function in Healthy Subjects

The proposed study will test dexamethasone effect on miRNA profile in healthy humans. As our data indicate that miRNA levels change over time, the investigators will study the time course of miRNA response to 1 mg IV dexamethasone within 60 minutes after injection. Dexamethasone is used routinely in human subjects for the treatment of inflammatory conditions and as a diagnostic tool in the evaluation of excess cortisol secretion (Cushing's syndrome). For the latter, 1 mg dexamethasone is given orally at midnight. Oral formula absorption in the gut can range from 20 to 60 minutes due to the presence of food and other factors. IV administration will bypass this variability and ensure an accurate and reproducible time-course study. The investigators will compare miRNA expression before and after dexamethasone treatment. The investigators will follow miRNA expression dynamics over a 1-hour time course to identify peak expression levels and to correlate miRNA expression with circulating dexamethasone levels. Dexamethasone and miRNA levels will be checked at baseline just before injection and then at 15, 30, 45, and 60 minutes after injection. Dexamethasone level is taken to verify treatment and to correlate it with miRNA expression.


Eligibility Criteria:
Inclusion Criteria:

* Adults age ≥ 18

Exclusion Criteria:

* Pregnancy
* Presence of a disease that affects HPA axis function
* Current use of medications that affect cortisol secretion, such as opioid pain medication, anti-fungal agents, anti-epileptic agents, and glucocorticoids, including hydrocortisone, prednisone, dexamethasone, steroid-containing inhalers, and steroid injected into the joints
* History of adverse event related to use of glucocorticoids
Essix Retainer vs Hawley Retainer

There are several factors involved in the decision and the retention plan, such as occlusion, patient age, etiology of malocclusion, the speed of the correction, the length of the cusps and health of the tissues involved, relationships inclined planes, size of the arches, harmony of the arches, muscle pressure, interdental proximal contact, cell metabolism and atmospheric pressure. Given these concepts, we need to find grounds to enable decision making with respect to the retainer that offers the best features of containment and stability.

This study aims to assess the stability of tooth position and occlusal retention during treatment with two types of retainers, Essix type retainer and the retainer plate type Hawley in individuals who have completed their growth ending orthodontic treatment at the Faculty of Dentistry University of Antioquia and CES University Medellín

Eligibility Criteria:
Inclusion Criteria:

* Patients who have stabilized their growth between 16 and 40 who have completed orthodontic treatment and initiate retention treatment
* Who have agreed to participate in the study if elected and to sign informed consent
* Residing in the metropolitan area of Medellin and have the opportunity to attend recall appointments

Exclusion Criteria:

* Periodontal status deteriorated
* missing teeth
* Cleft lip and palate
* History of orthognathic surgery
* History of dental or skeletal open bite
* Presence of some habit oral tongue thrusting, mouth breathing, thumb sucking even after termination of orthodontic treatment
Electromagnetic Field Therapy to Improve Healing of Chronically Venous Ulcer

Chronically venous ulcer in lower extremities is a permanent and disabling disease. Venous insufficience is the main cause of chronic ulcer. There is a high prevalence and frequency of the disease, primarily among elderly people. Recently, electromagnetic field therapy has been tested on various diseases in musculoskeletal system with a beneficial effect. In recent years, there has been an increasing interest in using electromagnetic field therapy to treat chronically venous ulcer.

The hypothesis of the investigators is that the electronic magnetic field therapy improves the healing process and reduces pain for patients suffering from chronically venous ulcer. The investigators assume that the bioactivity is affected by a cellular response which affects the DNA synthesis, transcription og protein synthesis.


Eligibility Criteria:
Inclusion Criteria:

* Patients who suffer from ulcer in lower extremities
* Patients who suffer from venous insufficience detected by duplex scanning or by a pressure on digits \> 40 mmHg
* Patients with a regular need of compression stockings
* Age \> 18 years

Exclusion Criteria:

* Age \< 18 years
* Unability to read or understand Danish
* Patients who suffer from manifest neoplastic disorder
Study of Retinal Oxygenation in Central Retinal Vein Occlusion

The purpose of the study is to test if oxygen saturation in retinal vessels is correlated with clinical parameters, such as visual acuity, central retinal thickness and presence of neovascularization. Retinal oximetry is performed with fundus camera based oximeters. The study will not entail change in treatment of the disease.


Eligibility Criteria:
Inclusion Criteria:

* Suspected central retinal vein occlusion.
* Informed consent for participation.
* No treatment before the first oximetry measurement.

Exclusion Criteria:

* History of other retinal disease. Glaucoma and diabetes without retinopathy are not exclusion criteria but should be registered.
* History of cardiovascular or respiratory diseases that can be expected to influence systemic or retinal oxygen saturation. Examples: Known COPD or carotid stenosis. Subjects with high blood pressure will not be excluded but blood pressure should be registered.
* Poor quality images will be excluded based on the images themselves. Therefore, grading of cataract or other media opacities is not strictly necessary for the purpose of the study.
Utility of High Flow Nasal Cannula in CO Toxicity

determination of the half-life of COHb in CO-poisoned patients with high flow nasal oxygen therapy in the ED.

Carbon monoxide (CO) poisoning is common and potentially fatal environmental emergency which requires immediate attention. It is responsible for up to 40,000 emergency department (ED) visits and 5000 to 6000 deaths per year, making it one of the leading causes of poisoning death in the United States. The management options for CO poisoning are limited to high flow oxygen by face mask or hyperbaric oxygen treatment. While half-life of carboxyhemoglobin (COHb) in a patient treating with high flow oxygen via a nonbreathing face mask is 90 minutes, it becomes 30 minutes with hyperbaric oxygen treatment (HBO).

The hypothesis of this study is using high flow nasal oxygen therapy in the CO poisoning may be more effective and safer treatment method comparing to standard oxygen therapy in the ED. Also, it may be a safe promising alternative of hyperbaric oxygen therapy.

The aim of the study is to determine the half-life of COHb in CO-poisoned patients with high flow nasal oxygen therapy in the ED.

Eligibility Criteria:
Inclusion Criteria:

* The patients who are admitted to the emergency department with CO poisoning with a CoHB level of \>10%.
* The patients who accept to participate in the study.

Exclusion Criteria:

* The patients who are \<18 years old.
* The patients who need mechanical ventilation
* The patients who are implemented oxygen more than 30 minutes before the ED admission
* The patients who will be transferred to the hyperbaric oxygen center before the CoHB levels are decreased to the half.
A Study to Examine the Use of Zemplar to Increase Serum Calcium Levels in ICU Subjects

A study to determine the effect of Zemplar on the regulation of serum calcium levels and the need for administration of elemental calcium in hypocalcemic intensive care patients


Eligibility Criteria:
Inclusion Criteria:

* ICU patients APACHE III score between 70 - 150 at screening and within 24 hours of enrollment and a whole blood ionized calcium level less than 0.90 mmol/L or corrected whole blood calcium level less than or equal to 7.5 mg/dL.

Exclusion Criteria:

* Serum creatinine greater than 2.5 mg/dL
Hypofractionation And Ultra-Hypofractionation In Adjuvant Radiotherapy For Breast Cancer

Prospective randomized study comparing 5 fractions in alternative days to standard 15 fractions regarding effectiveness and feasibility during adjuvant treatment in breast caner patients aged above 50 years

In Alexandria, the number of working linear machines are limited with overcrowded waiting list which lead to prolongation of overall treatment time and delay in starting radiotherapy. Providing the available data, Principle investigator is conducting this study in parallel with fast forward protocol to provide an alternative cost effective approach to patients.

The rationale behind hypofractionation depends mainly on the alpha beta ratio (α/β) and the overall treatment time. In Breast cancer the ratio is around 4 which is slightly lower than other tumors such as head and neck. The lower the ratio the higher the dose per fraction is needed to compensate slower proliferating tumors. Also, the overall treatment time could affect the local recurrence of breast cancer which is increased with long duration of treatment.

This study will include at least 100 patients with non metastatic histologically proved breast cancer who are indicated for adjuvant radiotherapy.

The patients will be randomized into two arms:

* Control arm: will include 50 patients who will receive standard 40.05 Gray (2.67 Gy/fx) over 15 fractions with or without boost over 3 weeks biologically effective dose (BED) for early and late effect equal 50.74.Gy10 and 75.69 Gy3 respectively.
* Experimental arm: will include 50 patients who will receive 26 Gray (5.2 Gy/fx) over 5 fractions over 1.5 weeks with BED for early and late effect equal 39.52 Gy10 and 71.07 Gy3 respectively

Eligibility Criteria:
Inclusion Criteria:

* Age ≥50 years old.
* Informed consent.
* Either breast conservative surgery or mastectomy.
* Invasive breast cancer with p T1-3, p N0-2.
* Non metastatic breast cancer proven by clinical examinations and imaging (X-ray chest and ultrasound or CT scan chest and abdomen).

Exclusion Criteria:

* Evidence of distant metastases.
* Prior irradiation.
* Inflammatory breast cancer.
* Tumor with T4 (skin nodules or fixed to chest wall or ulceration).
* Tumor with positive margins.
Pelvic Girdle Pain in a Pregnant Population in Western Norway.

The objectives in this study are

1. to explore the incidence and cumulative prevalence of pelvic girdle pain (PGP) and its subgroups in a prospective longitudinal study during pregnancy, from 18 weeks until 6 weeks after delivery.
2. to examine the outcome of chiropractic management for a dominating one-sided PGP subgroup of pregnant women in a single-blinded controlled study, and to use efficacy measures that include pain, functional impairment, and sick-leave frequency.
3. to investigate possible predictors for treatment outcome in one-sided PGP in pregnant women.


Eligibility Criteria:
Inclusion Criteria:

* Lumbopelvic pain
* Pelvic pain
* Performed ultrasound examination at 18th pregnancy week
* Expected normal pregnancy without complications
* Good competency in Norwegian language
Study of Trifluridine/Tipiracil (TAS-102) in Patients With Metastatic Colorectal Cancer in Asia

To compare the effects of TAS-102 with placebo in patients with metastatic colorectal cancer refractory or intolerable to standard chemotherapies.

This is a multinational, double-blind, two-arm, parallel, randomized Phase 3 comparison study evaluating the efficacy and safety of TAS-102 versus placebo in patients with refractory metastatic colorectal cancer. Patients will be randomly assigned (2:1) to TAS-102 (experimental arm) or placebo (control arm).

Eligibility Criteria:
Inclusion Criteria:

* Has provided written informed consent
* Has adenocarcinoma of the colon or rectum
* Has failed at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Is able to take medication orally
* Has adequate organ function (bone marrow, kidney and liver)
* Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.
Complete Clinical Responders to Definite Chemoradiation in Esophageal Cancer : a Survival Analysis

The aim of this study is to identify prognostic factors for outcome in patients being complete clinical responders with chemoradiation or radiation for esophageal cancer


Eligibility Criteria:
Inclusion Criteria:

* localized or locally advanced esophageal cancer
* patient who underwent definite chemoradiation or radiation
* patient with complete clinical response

Exclusion Criteria:

* metastatic disease
A Clinical Study on the Efficacy and Safety of ABCD in the Treatment of Patients With Invasive Fungal Disease

This study is a prospective, multicenter, single-arm study, that aims to evaluate the efficacy and safety of amphotericin B cholesterol-sulfate complex (ABCD) for injection in the first-line treatment of patients with invasive fungal diseases, hoping to provide a reference for the clinical treatment of invasive fungal diseases. Patients with hematologic diseases who meet the criteria for inclusion and discharge with febrile neutropenia and suspected fungal infection were treated with ABCD antifungal therapy for 14 days while receiving treatment for underlying diseases, and the response rate of treatment was observed.


Eligibility Criteria:
Inclusion Criteria:

1. Age≥ 18 years old, gender is not limited;
2. Patients with hematologic malignancies such as leukemia and lymphoma who have undergone chemotherapy or hematopoietic stem cell transplantation;
3. Peripheral blood absolute neutrophil count (ANC) \< 0.5×109/L, or expected ANC \< 0.5×109/L after 48 h;
4. Within 48 hours before the screening, at least 2 oral temperature measurements (with an interval of more than 30 minutes) ≥ 38.3°C (axillary temperature≥38.0°C), or ≥ 38°C (axillary temperature≥37.7°C) for more than 1h;
5. Received broad-spectrum antimicrobial therapy for at least 96 hours before screening but still had recurrent or persistent fever and suspected fungal infection;
6. The patient or his/her legal representative signs the informed consent form.

Exclusion Criteria:

1. Those who are allergic to amphotericin class B drugs or any component of the cholesterol-sulfate complex;
2. Patients with clinical suspicion of invasive fungal disease who have received antifungal therapy;
3. Patients with clinically diagnosed or confirmed invasive fungal disease (IFD) during the screening period;
4. Patients with abnormal liver function, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 5 times the upper limit of normal (ULN), or ALT or AST \> 3 times ULN and total bilirubin \> 1.5 times ULN;
5. Patients with reduced renal function, who need or are currently undergoing hemodialysis or peritoneal dialysis;
6. Clinically significant hypokalemia (defined as serum potassium \< 3.2 mmol/L, or blood potassium lower than the lower limit of normal while receiving digitalis therapy), and hypokalemia cannot be corrected before starting trial treatment;
7. Expected survival time\< 3 months;
8. Pregnant women, lactating women, or women of childbearing age who have not taken contraceptive measures and are planning to become pregnant;
9. Other investigators believe that it is not appropriate to participate in clinical trials.
Metabolic and Endocrine Effects of Repeated Epidural and Sacroiliac Joint Corticosteroid Injections

Corticosteroid injections into the epidural space or sacroiliac joint are increasingly used for the treatment of chronic neck, low back, and leg pain. These injections may have several side effects, including suppression of the body's adrenal glands to produce steroids (adrenal suppression) and negative effects on metabolism (weight gain, increased blood pressure, and high blood sugar levels).

The purpose of this study is to determine the time course and predictors of adrenal suppression and the metabolic effects of corticosteroid injections for chronic pain.

The investigators hypothesize normalization of adrenal function to occur within three weeks of injection in most individuals. An increased frequency of injections is predicted to lead to prolonged adrenal suppression. Corticosteroid injections are also hypothesized to lead to increases in body weight, blood pressure, and blood sugar levels, particularly in diabetic individuals.

Interventional pain procedures using corticosteroid injections (CIs), such as epidural steroid injections (ESIs) and sacroiliac joint injections (SIJIs), may have adverse metabolic and endocrine effects, including suppression of the hypothalamic-pituitary-adrenal axis (HPAA), hypertension, weight gain, and hyperglycemia. Based on sparse data on these adverse effects following repeated, long-term CIs, current guidelines suggest a maximum frequency of four to six injections annually, even though patients may benefit from more frequent treatments.

This prospective cohort study will follow first-time or repeat ESI or SIJI patients receiving injections with 0.5 mL bupivacaine 0.25% and 15 mg dexamethasone sodium phosphate at a maximum frequency of once every six weeks in order to:

* determine the frequency and duration of HPAA suppression;
* determine the incidence and predictors of prolonged (≥ 3 weeks) HPAA suppression;
* determine the baseline incidence and predictors of HPAA suppression in chronic pain patients presenting for their first CI; and
* determine the effect of CIs on body weight, resting blood pressure, and glycemic control over a six-month period.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving SI joint or epidural corticosteroid injections
* At least 18 years of age

Exclusion Criteria:

* Contraindication to corticosteroid injection (infection; pregnancy; uncontrolled diabetes mellitus \[per patient's report\]; active congestive heart failure; coagulopathy; medical conditions that prohibit holding anticoagulant or antiplatelet therapy, with the exception of aspirin, for at least two weeks prior to injection; and allergy to iodinated contrast dye, corticosteroids, or amide local anesthetics)
* Known disorder of the hypothalamic-pituitary-adrenal axis
* Corticosteroid injection within 6 weeks of study enrollment
NAION Treatment With Oral Prednisolone and Erythropoietin Injection

This randomized double-blind clinical trial is performed on all recent (within the last 5 days) NAION patients referred to hospitals affiliated to the Shahid Beheshti University of Medical Sciences, Iran. The patients will be equally and randomly assigned into two experimental groups and a control group. The first experimental group will receive 1000 units of erythropoietin every 12 hours for three days. The second experimental group will receive 50 mg of oral prednisolone from the onset of the disease for 1 week, with the dose gradually reduced within 2 weeks and then discontinued. In addition, the subjects in the second experimental group will receive 300 mg of ranitidine daily. The third group will receive placebo. Eye examination with color vision, perimetry, and peripapillary optical coherence tomography (to measure the thickness of the retinal nerve fiber layer) will be performed before the intervention, and 1, 3 and 6 months after the intervention. SITA standard visual field testing will be done using the Visual Field Analyzer Humphrey 750 Field (Carl Zeiss, USA). The thickness of the retinal nerve fiber layer will be measured by optical coherence tomography (Cirrus Zeiss Cirrus HD-OCT, Carl Zeiss, USA). The q-q plot and Kolmogorov-Smirnov tests will be performed to test normal distribution of data. Descriptive statistics including frequency, percentages, standard deviation, median and range will be used. Other statistical test including ANOVA, Kruskal-Wallis, Chi-Square, and Fischer's exact tests will be performed. All statistical analyses will be performed in SPSS (version 20) at significance level of 0.05.


Eligibility Criteria:
Inclusion criteria:

- All NAION patients (maximum time of disease occurrence: 5 days) referred to emergency department of Labbafinejad, Torfeh and Imam Hossein hospitals

Exclusion criteria:

1. Glaucoma or any ocular, neurologic or systemic disease affecting the vision
2. Abnormal laboratory test results such as ESR and CRP
3. History of ocular surgery
4. History of receiving medication for NAION
5. Uncontrolled systemic disease such as diabetes or hypertension
6. Contraindications of systemic steroids including active infection, active gastric ulcer, immunosuppression
7. Contraindications of erythropoietin administration, such as polycythemia
8. Unwillingness to participate in the study