cyrilzakka/clinical-trials huggingface dataset:
Effects of Platelet-rich Fibrin and Vitamin Dꝫ Injections on Root Resorption

This study aims to investigate and compare the effect of PRF and vitamin Dꝫ injections on root resorption by using CBCT

* Participants will be recruited from the Faculty of Dentistry, Beni-Suef University. All subjects will be informed of the treatment procedures and will sign a consent form.
* Subjects will be randomly divided into two groups:

Group 1 (PRF group): upper canine retraction will be facilitated by PRF injection that will be randomly assigned to one side (experimental side). The contralateral side will serve as the control one.

Group II (Vitamin Dꝫ group): canine retraction will be facilitated by Vitamin Dꝫ injection that will be randomly assigned to one side (experimental side). The contralateral side will serve as the control one.

* The predicted sample size (n) was a total of (28) cases (i.e. 14 cases per group). Sample size calculation was performed using G\*Power version 3.1.9.7
* Randomization:

Simple randomization will be designed with the aid of a computer-generated schedule with 1:1 allocation ratio. Allocation concealment will be achieved using identical opaque, sealed envelopes. Randomization and allocation concealment will be performed by one of the academic staff who will not be involved in the study and will keep the allocation table away from the operators. The operator will shuffle the sealed envelopes and will ask the patient to pick one envelope at the time of recruitment. In each group, a randomly selected side will act as the experimental side while the contralateral side will serve as the control. Blinding of the operators will not be applicable and so blinding will be limited to the outcome assessment.

- Methodology: All patients will be treated with a 0.022-inch MBT bracket system. Leveling and alignment phase will be completed until a 0.017 X 0.025'' stainless steel wire will be inserted passively into the bracket slot. Before canine retraction, the subject will be randomly assigned to one of the groups (PRF or Vitamin Dꝫ group). In both groups, canine retraction will be performed with closed Ni-Ti coil springs with a force of 150 g per side that will be adjusted by the use of a force gauge.

Eligibility Criteria:
IInclusion criteria:

1. Age: 18- 40 years old.
2. Angle Class I or Class II dental malocclusion that required bilateral maxillary first premolar extraction and upper canine retraction as a part of the treatment plan.
3. Good to fair oral hygiene.
4. Normal probing depth.

Exclusion criteria:

1. Active periodontal disease.
2. Poor oral hygiene.
3. Systemic diseases or medications that alter bone metabolism or tooth movement.
4. Craniofacial anomalies
Ischemic Post-conditioning in Acute Ischemic Stroke Thrombectomy

Ischemic post-conditioning is a neuroprotective strategy that has been proven to attenuate reperfusion injury in animal models of stroke. The purpose of this proof-of-concept study is to determine the safety and tolerability of ischemic post-conditioning in patients with acute ischemic stroke who are treated with mechanical thrombectomy.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years;
* Acute ischemic stroke caused by middle cerebral artery M1 segment occlusion;
* Successful recanalization (mTICI 2b/3) after endovascular thrombectomy that confirmed by digital subtraction angiography;
* Written informed consent provided by the patients or their legal relatives.

Exclusion Criteria:

* Known diagnosis or clinical suspicion of cerebral vasculitis or fibromuscular dysplasia;
* Difficulty in reaching the designated position of the balloon used for ischemic post-conditioning;
* Stenting in the middle cerebral artery as rescue therapy during the thrombectomy procedures;
* \> 2 times of balloon dilations as rescue therapy due to angioplasty during the thrombectomy procedures;
* Moderate or severe residual stenosis (≥ 50%) of the culprit artery after recanalization;
* Difficulty in complying with ischemic post-conditioning or other conditions that the investigator considered inappropriate for inclusion.
Perioperative Use of Gabapentin To Decrease Narcotic Requirements in Spinal Fusion

Blinded study using oral gabapentin in load pre-operative (15mg/kg) and maintenance 5mg/kg three times a day (TID) for 5 days or discharge, Patient Controlled Analgesia (PCA) morphine and placebo group with similar pills, also PCA morphine. The goal is to measure morphine usage and incidence of morphine side effects (pruritis, days foley, days to first stool, sedation, pain scores, PCA use).

Healthy, American Society of Anesthesia (ASA) 1-2 Idiopathic Scoliosis patients for spinal fusion.

Blinded, drug only known by hospital pharmacist. Study group 1- Gabapentin 15mg/kg with premed, 5/kg TID for 5 days of discharge, standard PCA morphine with dose and basal Study Group 2- Capsules resembling neurontin, with standard PCA morphine

No remifentanil, clonidine, ketamine

N=60 First patient enrolled 6/06 Last patient enrolled 7/15/08

Eligibility Criteria:
Inclusion Criteria:

* ASA 1-2, Idiopathic Scoliosis

Exclusion Criteria:

* ASA 3 or greater
* Neuromuscular scoliosis
* On narcotics baseline
Combination of Serum Measurements of Molecular Biomarkers and Serum Protein Profiling Can be Used to Predict Which Patients Undergoing Prostatic Biopsy Will be Diagnosed With Cancer

This is a prospective, serum proteomics study of men who are to undergo prostate biopsy. The purpose is to determine if proteomic profiles can be used to distinguish between men with prostate cancer on biopsy from men with no cancer on biopsy.


Eligibility Criteria:
Inclusion Criteria:

* Men aged 18 years or older
* Have a PSA level between 2 and 10 ng/ml
* May or may not have an abnormal digital rectal examination
* Scheduled for trans-rectal ultrasound (TRUS) guided systematic prostate biopsy as part of routine medical care. All sites (Department of Urology at SUNY Downstate Medical Center, Brooklyn, the Department of Urology, New York Presbyterian Hospital, Weill Medical College of Cornell University, Manhattan and the Department of Urology, Kings County Hospital) will perform a standardized 14 core biopsy protocol.
* Signed, informed consent
* Patient must be able to attend the pre-biopsy blood draw

Exclusion Criteria:

* Any period of prior/current treatment with hormonal therapy (LHRH agonist/antagonist,antiandrogen, 5-alpha-reductase inhibitor)
* Prior pelvic radiation
* A period of less than 6 months prior/current treatment with an alpha-blocker
* Previous diagnosis of prostate cancer
Tacrolimus Minimization in Kidney Transplant Recipients Selected According to the AGORA Algorithm for Their Low Immunological Risk and Medium-term Graft Failure

The goal of this clinical trial is that validation of the non-invasive biomarkers of the AGORA algorithm should make it possible to select patients with a very low immunological risk of graft failure to authorize safe minimization of their immunosuppression for adult patients at one-year post kidney transplantation.

The main question of the AGORAC trial is to demonstrate the impact of TACROLIMUS minimization using AGORA algorithm compared to standard of care on the kidney function 18 months after the minimization period.


Eligibility Criteria:
Inclusion Criteria:

* First kidney transplantation
* Living or brain death or
* Donation after circulatory death (Maastricht 3) donor,Compatible for ABO group with the donor,
* cPRA (Panel Reactive Antibody Calculated ) (or TGI: Incompatible Graft Rate )\<20% on the day of the transplantation and no DSA (MFI \<500) at pre transplant and at the time of the inclusion at one-year post transplantation (between 350 and 515 days after the transplantation.
* Normal or IFTA 1-2 histology on one-year surveillance biopsy.
* Patient insured under a health insurance scheme, according to national regulation.
* Patient (of childbearing age) with effective contraception.
* Patients treated with Tacrolimus (Prograf® or Advagraf®) and MMF / MPS (Mycophenolate Sodium) +/- Corticosteroid (CS)

Exclusion Criteria:

* Donation after circulatory death maastricht 2 (uncontrolled) and maastricht 1
* Pregnant women (serum or urine test), breastfeeding women
* Patient under legal protection (incl. under guardianship or trusteeship)
* Participation to a drug interventional study within 1 month prior to the inclusion
* Any retransplantation and combined transplantations and also other organ previous transplantations
* History of lymphoproliferative disorders
* Diagnosis of a malignant disease (according to the type of malignancy)
* Hepatitis C antibody or hepatitis B surface antigen (HbsAg) positive patient or HIV infection
Study of Aprepitant (MK-0869) for Chemotherapy-Induced Nausea and Vomiting (CINV) in Adolescent Participants (MK-0869-097)

This study is being conducted to demonstrate that aprepitant (MK-0869) prevents nausea and vomiting caused by emetogenic cancer chemotherapy in adolescent participants. Participants treated with emetogenic cancer chemotherapies that include either cisplatin, cyclophosphamide, or carboplatin, or participants who experienced nausea and/or vomiting when treated with a previously administered chemotherapy regimen that is planned to be repeated will be enrolled in this study. In the double-blind Part 1 of this study, enrolled participants will be randomized to receive either aprepitant or standard therapy. In Part 2 of this study, enrolled participants will receive open-label aprepitant.

The duration of treatment is the first 4 days of one 28-day cycle (Cycle 1). Participants who successfully complete Cycle 1 may be eligible to participate for 9 subsequent optional, open-label, 28-day cycles.

Eligibility Criteria:
Inclusion Criteria:

* Cycle 1: Participant is to be treated with an emetogenic chemotherapy regimen that includes either cisplatin, cyclophosphamide, or carboplatin, for a documented malignancy. OR Participant did not tolerate a previously administered chemotherapy regimen, for a documented malignancy, secondary to nausea and/or vomiting that is planned to be repeated.
* Cycle 1: Participant has Karnofsky score ≥60
* Cycle 1: Participant has a predicted life expectancy of ≥3 months

Exclusion Criteria:

* Cycle 1: Participant will receive stem cell rescue therapy in conjunction with course of chemotherapy.
A Real World Study of Anti-PD-1/PD-L1 Antibodies for the Treatment of Advanced Solid Tumors

The study was designed to analyze the efficacy and safety of anti-PD-1/PD-L1 antibodies for the treatment of advanced solid tumors.

The study is a real-world study and the case records of patients with advanced solid tumors who visited Department of Medical Oncology, Chinese PLA General Hospital from 2015 to 2019 and received anti-PD-1/PD-L1 antibody therapy will be collected in this study. The medical data including patient demographic, tumor characteristics, laboratory examination, history of treatments, adverse reactions, and so on will be extracted to analyze the effectivity and safety of anti-PD-1/PD-L1 antibodies and explore the prognosis-relevant factors of advanced solid tumors.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically or cytologically confirmed advanced solid tumors;
* Received anti-PD-1/PD-L1 antibody therapy.

Exclusion Criteria:

* No specific exclusion criteria in this real world study.
A Study of the Antioxidant Probucol Combined With Valsartan in Patients With IgA Nephropathy

a statement of the study hypothesis:the effect of valsartan in patients with IgA nephropathy have been proved,and the efficacy of probucol in combination with valsartan is to be proved in patients with IgA nephropathy.

This is a prospective randomized controlled, double blinded pilot study to identify the efficacy of probucol in combination with valsartan in patients with IgA nephropathy. The renal function deterioration will be the primary outcome studied. The expected study duration will be 36 months.


Eligibility Criteria:
Inclusion Criteria:

* Patients who fulfill the clinical and pathological criteria for IgA nephropathy
* Age: 18-60 years
* Renal biopsy diagnostic for IgA nephropathy based on immunohistologic staining for IgA that is greater than or equal to staining for IgG and IgM
* Urinary protein excretion rate is within the range of 1-2.5g/day
* Serum creatinine \<265.2umol/L at the time of randomization

Exclusion Criteria:

* Patients who refuse to be randomized for treatment
* Patients who prefer treatment with conventional agents
* Patients who are pregnant or plan for pregnancy
* Patients who are pathologically proven severely or diffusely proliferative IgA nephropathy or crescent glomerulonephritis with \>= 50% segmental involvement of the glomeruli and should be treated with other agents,such as immunosuppressive agents or steroid
* Clinical and histologic evidence of:

  * systemic lupus erythematosus
  * Henoch-Schonlein purpura
  * cirrhosis
  * chronic active liver disease
  * hepatitis B
  * hepatitis C
  * severe chronic diarrhea
  * active peptic ulcer disease
  * HIV
  * acute renal failure
  * malignant hypertension
  * severe heart diseases
  * malignant tumor
  * any systemic infection
  * pregnancy
  * Known contraindication to the administration of probucol and valsartan
Risk Factors for Refeeding Syndrome in the Surgical Intensive Care Unit

Refeeding Syndrome is a condition that occurs when patients who are undernourished or undernourished suddenly start overfeeding, causing electrolyte disturbances and vitamin deficiencies, resulting in neurological and cardiac problems. It may even result in death. It is aimed to prevent the development of Refeeding Syndrome with nutrition in accordance with the guidelines. The aim of this study is to determine the risk factors for Refeeding Syndrome in Intensive Care Unit (ICU).

Nutritional support is an important part of treatment in intensive care patients. Especially existing comorbidities and developing acute problems before intensive care admission can cause serious malnutrition for patients. Refeeding syndrome is a serious, life-threatening condition accompanied by electrolyte and metabolic disorders as a result of rapid re-feeding following prolonged starvation or malnutrition. The condition may be accompanied by electrolyte disorders such as hypophosphatemia, hypokalemia and hypomagnesemia, as well as decrease in vitamin levels (especially vitamin B1), fluid imbalance and salt retention. The resulting imbalances can cause cardiac and neurological side effects, impaired organ functions and even death. The refeeding protocol should be individualized to each patient's clinical situation. In this study, although nutritional protocols in accordance with the guidelines are applied in patients with risk factors for the development of Refeeding Syndrome, whether Refeeding Syndrome develops and the facilitating factors will be investigated in ICU.

Eligibility Criteria:
Inclusion Criteria:

1. Patients are intensive care patients
2. Patients' age \> 18 -

Exclusion Criteria:

1. Diabetic ketoacidosis
2. Other risk factors for hypophosphatemia (patients on continuous hemodialysis, hyperphosphatemia treatment, parathyroidectomy)
3. Patients with pre-study hypophosphatemia (\< 0.65 mmol/L)
4. Patients with hyperparathyroidism
5. Terminal stage cancer patients
6. Patients with Glasgow Coma Scale ≤5
7. Patients with respiratory and metabolic alkalosis -
A Study of Fabrazyme in Pediatric Patients With Fabry Disease

People with Fabry disease have an alteration in their genetic material (DNA) which causes a deficiency of the a-galactosidase A enzyme. This enzyme helps to break down and remove certain types of fatty substances called "glycolipids". These glycolipids are normally present within the body in most cells. In people with Fabry disease, glycolipids build up in various tissues such as the liver, kidney, skin, and blood vessels because a-galactosidase A is not present, or is present in small quantities. The build up of glycolipid levels (also referred to as "globotriaosylceramide" or "GL-3") in these tissues is thought to cause the clinical symptoms that are common to Fabry disease. Symptoms commonly appear during childhood with pain in the hands and feet. This study explored the safety, efficacy and pharmacokinetics of Fabrazyme in pediatric patients aged between 7 and 15 years.


Eligibility Criteria:
Inclusion criteria:

* Patient or legal guardian must provide written informed consent
* Patients must have a clinical diagnosis of Fabry disease and active Fabry disease (clinical signs and symptoms)
* Patients must be at least 7 years of age but no older than 15 years of age at time of enrollment
* Patients must be Tanner Stage ≤ III
* Female patients must have a negative pregnancy test prior to each infusion and use a medically accepted form of contraception throughout the study

Exclusion Criteria:

* Patient has a clinically significant organic disease (with the exception of symptoms relating to Fabry disease) that in the opinion of the investigator would preclude participation in the trial
* Patient has participated in a study employing investigational drug within 30 days of the start of this study
* Patient has received prior treatment with enzyme replacement therapy
* Patient is unable to comply with the clinical protocol
A Two Arm, Multi-Centre Clinical Evaluation of the NxTAG Respiratory Pathogen Panel

xTAG RPP assay is a PCR-based assay to detect the presence or absence of viral and bacterial DNA / RNA in clinical specimens (nasopharyngeal swabs).

The objective of this study is to establish diagnostic accuracy of the xTAG RPP.


Eligibility Criteria:
Inclusion Criteria:

* The specimen is a nasopharyngeal swab.
* The specimen is from a pediatric or adult, male or female subject who is either hospitalized, admitted to a hospital emergency department, visiting an outpatient clinic or resident of a long-term care facility.
* The specimen is from a patient exhibiting clinical signs and symptoms of respiratory tract infection such as fever, sore throat, shortness of breath, bronchitis, bronchiolitis and pneumonia.

Exclusion Criteria:

* The specimen is not a nasopharyngeal swab.
* The specimen is from an individual who does not exhibit clinical signs and symptoms of respiratory tract infection.
Evolution of Proteomic Profiles of Intestinal Microbiota in Patients With Locally Advanced or Metastatic Urothelial Carcinomas

Immunotherapy has become an essential therapeutic weapon against many cancers. Control point inhibitors (CPI, PD-1/PD-L1) have shown efficacy in the therapeutic management of tumors in the bladder in progression after administering platinum derivatives. But only 20% of patients get any clinical benefit from these heavy treatments in the long term.

Treating metastatic patients without distinction means taking a considerable risk of toxicity and generates major costs. It is therefore urgent and important to exceed the current criteria for using immunotherapy. Recent studies have shown the interest of studying intestinal microbiota as a marker of the efficacy of immunotherapy.

The investigators hypothesized that the proteomic signature of the intestinal microbiota in patients with locally advanced or metastatic urothelial carcinomas who responded to immunotherapies was special, and has very different characteristics from that of patients with the same pathology who do not respond to immunotherapy.


Eligibility Criteria:
Inclusion Criteria:

For the "controls" group:

* Patients undergoing treatment for a locally advanced or metastatic urothelial tumor
* Patients who have been on immunotherapy and 2nd-line monotherapy treatment for at least 6 months for a non-operable disease
* Patients whose immunotherapy has been interrupted due to progression of the disease

For the "cases" group:

* patients being treated in the context of a temporary authorization for use delivered for atezolizumab for the management of locally advanced or metastatic urothelial carcinomas following treatment based on platinum salts and still on treatment or patients being treated with pembrolizumab in the context of a donation for compassionate reasons (and still on treatment).

Exclusion Criteria:

* Patients who do not speak or read the French language.
* Patients in an exclusion period determined by another study.
* Patients under legal guardianship or curatorship.
* Patients for whom it is impossible to give clear information to.
The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UTTR1147A in Participants With Neuropathic Non-Healing Diabetic Foot Ulcers

This trial will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of repeat dosing of UTTR1147A in participants with neuropathic diabetic foot ulcers that do not respond adequately to standard wound care. Participants across multiple sites will be assigned to one of five cohorts (Cohort A, B, C, D, and E) based on the eligibility criteria and randomized to receive subcutaneous (SC) injections of either UTTR1147A or placebo over 12 weeks in addition to standard wound care.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of Type 1 or Type 2 diabetes and confirmed peripheral neuropathy
* Have adequate circulation to the foot
* Have an ulcer area at screening up to 6 cm\^2
* Up to date on all age-appropriate cancer screenings per local standards

Exclusion Criteria:

* Have current evidence of osteomyelitis, cellulitis, or evidence of systemic infection
* Have gangrene present on any part of the affected foot
* Known peripheral arterial disease requiring revascularization
* Have a glycated hemoglobin A1C level of greater than (\>) 15% assessed at screening
* Are receiving oral or parenteral corticosteroids, immunosuppressive, or cytotoxic agents
* Have active malignancy or any history of a malignancy
* Use of oral antibiotics at the time of randomization for any reason in participants to be enrolled in Cohorts A, B, E, and any additional uninfected patient cohorts