cyrilzakka/clinical-trials huggingface dataset:
Influence of Mucosa Tissue Thickness on Marginal Bone Loss of Implants With Smooth Collars

The primary objective of this study is to compare the amount of implant marginal bone loss radiographically and probing depth in between thin and thick mucosa group that will receive a machined collar implant.

Null hypothesis is mucosa thickness does not affect implant marginal bone loss on implant with smooth collar.

Twenty eight adult patients who fulfill the inclusion criteria will be divided into 2 groups based upon the mucosa thickness (\<2 mm and ≥2 mm). A signed written informed consent will be obtained from all subjects. Subjects will not be screened or treated until an informed consent has been obtained. Patient information will be protected according to the privacy regulations of the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA).

The enrolled patients will receive implants with 1 mm polished collar. Implants will be restored at 4 (±1) months after placement. Outcome analyses will be performed until 1 (±1 month) year after loading and clinical and radiographic parameters will be evaluated to compare clinical outcomes between groups. The primary outcome is implant marginal bone loss and probing depth from clinical and radiographic measurements.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* Aged ≥18
* In need of one dental implant in the Maxillary or Mandibular area, can be an anterior, premolar, or 1st molar tooth
* Natural adjacent teeth
* Bone height of ≥10mm
* Bone width of ≥5mm
* Good oral hygiene
* Stable periodontium
* Willingness to fulfill all study requirements

Exclusion Criteria:

* Need bone augmentation
* Need one dental implant that is a 2nd or 3rd molar tooth
* Current smoker or quit smoking less than one year
* Pregnant or plan to get pregnant
* Uncontrolled diabetes (HbA1C \> 7)
* Medical conditions that may influence the outcome of the study (neurologic or psychiatric disorders, systemic infections )
* Current use of oral bisphosphonates
* History of IV bisphosphonates
* History of radiation therapy in the head and neck area within 4 years
* Poor oral hygiene (plaque score more than 40% based on O'Leary plaque score)
* Once a group has been filled, subjects who meet the criteria of that group will be excluded
Genistein in Treating Patients With Prostate Cancer

RATIONALE: Genistein may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This randomized phase II trial is studying how well genistein works in treating patients with prostate cancer.

PRIMARY OBJECTIVES:

I. Determine whether genistein treatment will decrease the number of circulating prostate cells (CPCs) in the peripheral blood as measured by qRT-PCR for PSA performed on RNA extracted from peripheral blood mononuclear cells (PBMNCs).

SECONDARY OBJECTIVES:

I. Determine the natural history of circulating prostate cells (CPCs) in a cohort of subjects prior to and post radical prostatectomy.

II. Compare the measurement of PSA between three separate methods: in CPCs by qRT-PCR, in serum by the standard clinical chemistry assay (i.e., ELISA), and in plasma and serum by the nano-PSA assay.

III. Measure the effect of genistein on gene and protein expression in prostate tissue by qRT-PCR and immunohistochemistry, respectively, for the following genes and their respective protein products: HSP27, MMP-2, ALK-2, BASP1, and HCF2.

OUTLINE:

Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive oral genistein once daily for 3 months beginning at least 1 month prior to radical prostatectomy.

ARM II: Patients receive oral placebo once daily for 3 months beginning at least 1 month prior to radical prostatectomy.

All patients undergo radical prostatectomy at least 2 weeks, but not more than 3 months following the start of therapy.

After completion of study treatment, patients are followed at 1, 6, and 12 months.

Eligibility Criteria:
Inclusion

* Participants must have a pathologic diagnosis of prostate cancer within the past 6 months, have clinical stage T1-3 disease, PSA \>= 10, Gleason score \>= 8, and have elected to undergo radical prostatectomy; those found to have detectable circulating prostate cancer cells in the blood as detected by qRT-PCR for PSA will be eligible to proceed onto the treatment phase of the protocol; pathology slides used for diagnosis will be submitted to the SPORE tissue pathology core for review
* ECOG performance status 0-1
* Hemoglobin \> 9.0gm/dl
* Platelets \>= 100 K/uL
* ANC \> 1000/uL
* AST (SGOT)/ALT (SGPT) \< 3X upper limit of normal
* Creatinine \< 2.0 mg/dl
* Total bilirubin \< 2 mg/dl (Note: Subjects with a higher level of bilirubin due to a familial defect in bilirubin metabolism will be considered on an individual basis)
* Participants must agree not to take soy supplements
* Ability to understand and the willingness to sign a written informed consent document
* Willingness to take study agent for at least 2 weeks prior to radical prostatectomy

Exclusion

* History of venous thrombosis within past year
* Participants must not be receiving active therapy for neoplastic disorders (including hormone or radiation therapy for prostate cancer)
* Participants may not be receiving any other investigational agents
* Known soy intolerance
* Medical conditions that, in the opinion of the investigators, would jeopardize either the patient or the integrity of the data obtained
ET-01 in Subjects With Lateral Canthal Lines, LCL-209

This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A, topical, in lateral canthal lines (LCL).

This product is being tested for its ability to reduce lateral canthal lines (LCL), also known as Crow's Feet.

Eligibility Criteria:
Inclusion Criteria:

* females 25 - 65 years of age
* minimal to moderate Crow's Feet wrinkles at rest
* moderate to severe Crow's Feet on contraction
* adequate vision to assess facial wrinkles in a mirror
* willingness to refrain from products affecting skin remodeling
* female subjects must be not pregnant and non-lactating
* subjects should be in good general health

Exclusion Criteria:

* history of adverse reactions to any prior botulinum toxin treatments
* history of vaccination or non-response to any prior botulinum toxin treatments
* botulinum toxin treatment in the prior 6 months
* present or history of neuromuscular disease, eyelid ptosis, muscle weakness, paralysis, or "dry eye"
* history of peri-ocular surgery, brow lift or related procedures
* procedures affecting the lateral canthal region in the prior 12 months
* application of topical prescription medication to the treatment area
* female subjects who are pregnant or are nursing a child
FMRI Brain Activation of Aripiprazole Treatment in Autism Spectrum Disorders

This is an 8 week research study of aripiprazole (abilify) which is used to reduce irritable behaviors in autism spectrum disorders. All participants will receive active study medication. Participants will also receive diagnostic and cognitive evaluations at no cost. Participants will be required to undergo two fMRI (functional magnetic resonance imaging scans) where we will take pictures of your brain while performing simple tasks.


Eligibility Criteria:
Inclusion Criteria:

* male or female of any race or ethnicity
* ambulatory status (outpatient) at time of consent
* age 10-55 inclusive at time of consent
* clinical diagnosis of autism spectrum disorder and meets screening criteria on the Social Communication Questionnaire as well as either the Autism Diagnostic Observation Schedule (ADOS) or the Autism Diagnostic Interview-Revised (ADI-R) administered by raters trained to research reliability.
* estimated IQ greater than 70 and capable of making an informed decision based on assessment of their understanding and judgment
* Children's Yale-Brown Obsessive Compulsive Scale: Modified for Pervasive Developmental Disorders (PDD-CYBOCS) \> 8 as assessed during telephone screening.
* Free of psychoactive medication for at least: one month for fluoxetine; two weeks for other SSRIs and neuroleptics; and five days for stimulants prior to MRI scanning \[excepting stable doses (greater than three months duration) of anticonvulsant medication for seizure disorder\]
* Currently taking psychoactive medication that is not providing sufficient relief of repetitive behaviors and willing to discontinue all psychoactive medication for the duration of the study.
* Judged reliable for medication compliance and agreeing to keep follow-up study appointments.

Exclusion Criteria:

* Age less than 10 years or greater than 55 years at time of consent
* Estimated IQ less than 70
* Uncontrolled epilepsy (seizure within 6 months prior to consent)
* Presence of medical conditions that might interfere with participation, or where participation would be contraindicated.
* History of neurological injury: head trauma, poorly-controlled seizure disorder (seizure within the preceding six months), stroke, prior neurosurgery, or under the care of a neurologist or neurosurgeon as determined by interview
* History of claustrophobia
* Implanted or irremovable metal in the body (including certain tattoos and permanent make-up).
* Current pregnancy in females
* Inability to communicate satisfactorily and directly (without a translator) in English
* Medical contraindications to aripiprazole therapy as determined by history (including induction of neuroleptic malignant syndrome, dystonic reaction, or known drug allergy)
* Ongoing need for psychoactive medication other than study medication \[excepting stable doses (greater than 3 months duration) of anticonvulsant medication for seizure disorder or diphenhydramine for sleep
* prior history of aripiprazole treatment failure at appropriate doses and duration
* clinically significant low white blood cell count at baseline
Air Versus Saline Solution for the Localization of the Epidural Space in Labour Analgesia

Epidural space localization using loss of resistance technique with air (ALOR) is controversial in obstetric analgesia due to a minor efficacy and risk of complications, compared with loss of resistance technique with saline (SLOR). This randomized prospective study will compare the efficacy and incidence of most common complications of both techniques in obstetric analgesia.

A local ethics committee has approved the study. A statistical power calculation was performed and 177 patients per group will be necessary to confirm a 20% difference of efficacy of the block at 30 minutes (α=0,05; β=0,1). Epidural catheter will be inserted and a standardized analgesic protocol will initiate. The efficacy of the block will be assessed after 30 minutes and at delivery. The apparition of adverse effects during puncture and labour will be annotated. The need for repuncture of the block and the repercussion of the technique on the delivery and the fetus will be recorded as well. At 24 hours, investigators will assess the incidence of pain at the site of puncture (PSP) and the level of maternal satisfaction on a 0 to10 numeric scale.

Eligibility Criteria:
Inclusion criteria:

* Parturients asking for epidural analgesia during labour .
* Age between 18 and 45 years.
* Spontaneous or induced.
* Cervical dilatation inferior to 6 cm.
* Written informed consent.

Exclusion criteria:

* Infection in the puncture site.
* Refusal of the patient.
* Coagulopathy.
* Severe hypovolaemia.
* Intracranial hypertension.
* Severe aortic or mitral stenosis.
* Systemic infection.
* Non collaborating patient.
* Incapacity of communicating or lack of comprehension of the study by the parturient
* Prior neurological symptoms or demyelinising lesions.
* Valvular stenosis.
* Severe spinal deviation.
* Patient previously operated of spinal surgery in the site of puncture.
Removal of Beta Blocker Drugs by Hemodialysis

Eight maintenance hemodialysis patients are given one of four beta blocker drugs (atenolol, bisoprolol, carvedilol, metoprolol) three hours prior to a hemodialysis session. Blood samples and spent dialysate are collected during dialysis. On separate dialysis sessions, patients received the other study drugs until they have taken each of the four study drugs. Dialytic clearance is calculated.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age, receiving hemodialysis three times per week for at least 90 days.

Exclusion Criteria:

* gastrointestinal or liver disease, body mass index greater than 40 kg/m2, contraindications for receiving a beta blocker (treatment with contraindicated medications, prior adverse reaction, severe reactive airway disease, hemodynamic instability during dialysis).
Placental Transfusion and Cord Clamping

To compare the evolution of the infant's weight before delayed cord clamping (2 minutes after birth) as an indirect measure of the volume of placental transfusion in a group of healthy and fullterm newborns, placed at the level of the introitus versus another group placed on the abdomen of the mother.

No inferiority, Randomized controlled trial not blind, Multicenter. Informed consent will be obtained during pregnancy or admittance and previous to birth.

Hypothesis: Placing the infant on the maternal abdomen without cord clamping during the first 2 minutes after birth does not change significantly the transfusion volume as compared to infants whose cord is clamped after 2 minutes but who are placed at the level of the introitus

Term newborns by vaginal delivery and without complications will be included. Study subjects will be assigned to two groups, both with delayed clamping,according to a sequence of random numbers generated by computer. The assignment will be done through opaque, sealed, easy opening envelopes, opening the envelope at the moment the mother enters the delivery room. Both parents and obstetric group will be then informed about which group the infant will be assigned to.

In both groups: The newborn will be immediately placed on a scale, previously set at the level of the maternal introitus to record his/her weight.

Group 1: Clamping at level of introitus: The infant will be held by the neonatologist at introitus level,immediately after the initial weight Group 2: Clamping on Maternal Abdomen: The newborn will be placed on the abdomen of the mother immediately after the first weight measurement.

In both groups:A plastic clamp will be put at approximately 1cm from the cutaneous insertion of the umbilical cord at 120 seconds after birth and then a new Weight will be obtained after clamping.

Weight differences will be evaluated when positioning the infant at the level of the introitus or on the maternal abdominal-thoracic level (at or over placental level).

Eligibility Criteria:
Inclusion Criteria:

* Term newborns
* vigorous born by vaginal delivery
* informed consent Signed.

Exclusion Criteria:

* History of Placenta previa,
* postpartum hemorrhage background,
* Multiple gestation.
* Background of IUGR prenatally diagnosed.
* Major congenital malformations diagnosed previous to delivery.
* Maternal diseases such as: eclampsia, Rh incompatibility, congestive cardiac failure.
* Extraction of blood sample for bank of umbilical cord stem cells.

Elimination criteria:

* Need for immediate assistance of the newborn,
* Birth weight less than 2500 g,
* Nuchal cord wrapped too tight,
* Major congenital malformations not diagnosed during prenatal period,
* Delivery surgically finished Short umbilical cord which might prevent placing the infant in the assigned place .
Pregabalin Reduce the Sevoflurane Requirement

Preoperative administration of pregabalin would reduce the end tidal concentration of sevoflurane during laparoscopic cholecystectomy with added beneficial improving of the quality of postoperative analgesia.

laparoscopic cholecystectomy is a painful and stressful surgical procedure. Pregabalin is a lipophilic structural analogue of the inhibitory γ-aminobutyric acid by binding to the presynaptic voltage-gated calcium channels that are widely distributed throughout the central and peripheral nervous system. Pregabalin has anticonvulsant, anxiolytic, sleep-modulating, anti-hyperalgesic, opioid-sparing6 and anti-allodynic properties through inhibition of the release of excitatory neurotransmitters such as glutamate, norepinephrine, serotonin, dopamine and substance P. These unique characteristics make pregabalin as a useful therapeutic for treating neuropathic pain and acute postoperative pain in several models of incisional injury and inflammatory conditions including laparoscopic cholecystectomy.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists class I and II
* scheduled for elective laparoscopic cholecystectomy
* under sevoflurane anesthesia

Exclusion Criteria:

* communication barriers
* cardiovascular diseases
* renal diseases
* hepatic diseases
* endocrinal diseases
* neuropsychiatric diseases
* prolonged P-R interval
* pregnancy
* nursing
* hypersensitivity
* treated by pregabalin, antidepressant, anticonvulsants, opiates or benzodiazepines during the last week
Investigation of Hyperhidrosis Treatment Using the Nd: YAG 1440nm Wavelength Laser

The purpose of this study is to evaluate the safety and efficacy of the Nd:YAG 1440 nm wavelength laser for the treatment of primary hyperhidrosis of the axilla.


Eligibility Criteria:
Inclusion Criteria:

* A healthy non-smoking male or female between 18-56 years of age
* Understand/accept obligation not to receive any other procedures in anatomical areas exhibiting axillary hyperhidrosis through 3 months prior to treatment
* Understand and accept the obligation and is logistically able to present for all scheduled follow-up visits
* Clinically diagnosed for primary hyperhidrosis of the axilla.
* A self assessed Hyperhidrosis Disease Severity Scale (HDSS) score of three (3) or four (4)

Exclusion Criteria:

* Clinical diagnosis of secondary hyperhidrosis
* Uncontrolled systemic disease
* Concurrent use of any hyperhidrosis treatments other than over the counter antiperspirants or deodorants
* Receipt of Botox or Dysport within the past six months
* Patients who refuse to stop using over the counter antiperspirants 24 hours prior to the day of surgery and each of the follow-up visits at 3 months and 6 months that Minors starch iodine tests may be performed.
* Patients using or having used within 7 days of baseline visit: cholinomimetic agents, anticholinergic agents, prescription antiperspirants, any herbal medicine treatments or any other treatments for hyperhidrosis except over the counter antiperspirant or planning to use such agents during the course of the study.
* Any previous liposuction/liposculpture or any type of surgery for hyperhidrosis; OR any other types of treatments for hyperhidrosis in the area to be treated in the past 6 months or planning to have any treatments for hyperhidrosis or surgery within the treatment area during the course of the study.
* Allergies to medication or local anesthesia required for the procedure
* A history of thrombophlebitis
* A history of acute infections
* A history of heart failure
* Received or is anticipated to receive antiplatelets, anticoagulants, thrombolytics, vitamin E or anti inflammatories within 2 weeks pre treatment
* An intolerance to anesthesia
* Any medical condition, that, in the investigator's opinion would interfere with the patient's participation in the study
* Taking medications that are photosensitive
* A history of keloid formation
* Is pregnant or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the course of the study
* Study subjects that can not maintain their pre-study exercise and diet routine over the course of the study
Surgery for Primary Congenital Glaucoma in Neonates

The current study aimed to compare between the long-term surgical outcomes of 3 surgical options (viscotrabeculotomy (VT), visco-circumferential-suture-trabeculotomy (VCST) or combined VT-Trabeculectomy with MMC (VT-Trab) in treatment of infants with (Primary Congenital Glaucoma (PCG)) below 1 month of age.

This is a prospective, randomised controlled trial. We plan to recruit 60 infants with primary congenital glaucoma and younger than 1 month of age at the outpatient clinic of Mansoura Ophthalmic Center of Mansoura University in Mansoura, Egypt. Eyes will be randomly assigned to undergo one of 3 surgical interventions: viscotrabeculotomy (VT), visco-circumferential-suture-trabeculotomy (VCST) or combined VT-Trabeculectomy with MMC (VT-Trab).

The primary outcome of this study is compare the success rate in lowering IOP between the 3 surgical options in infants with Primary Congenital Glaucoma (PCG) below 1 month of age. The secondary clinical outcomes will include Intraocular pressure (IOP), horizontal corneal diameter, axial length, cup-disc ratio, refractive error and postoperative complications in these 3 surgical procedures. Data will be analysed. Complete success was defined as an IOP from 5 to 16 mmHg (under general anesthesia), without antiglaucoma drugs (AGD) or further surgical interventions, without progression of corneal diameter or disk cupping, and without serious visual complications. Qualified success was defined as fulfilling the same criteria but with the use of AGD.

Eligibility Criteria:
Inclusion Criteria:

Primary Congenital Glaucoma in Neonates

Exclusion Criteria:

secondary Congenital Glaucoma in Neonates. Congenital Glaucoma presented after 1 month of age.
Australian Genomics Of Chronic Allograft Dysfunction Study

The goal of the Australian Genomics of Chronic Allograft Dysfunction (AUSCAD) study is a single centre (Westmead Hospital), prospective, observational study, which enrols patients at time of kidney (or kidney-transplant) transplant and tracks the post transplant course. The AUSCAD study aims to generate new knowledge and improve outcomes following kidney transplantation. The primary aim is to determine whether important outcomes (including chronic rejection and graft loss) are correlated with patterns of allograft reactivity, gene expression and susceptibility profiles.


Eligibility Criteria:
Inclusion Criteria:

* Living or deceased donor kidney transplant candidate.
* Biological sex: any
* Ages: 18-75 years.
* Subject must be able to understand and provide informed consent.
* Deceased donor individuals where Research Consent has been obtained from the person consenting to organ donation at the time of organ retrieval.
* Identifiable living donors who have received informed consent and have consented to participate in the project.

Exclusion Criteria:

* Presensitization in living donor recipients prior to transplantation, as determined by site-specific standards, OR positive cross match according to site specific technique in cadaveric donor recipients.
* Recipients of multiple organ transplants, with the exception of kidney/pancreas transplants.
* Inability or unwillingness of a participant to give written informed consent or comply with study protocol
* High risk populations including pregnant women, children less than 18 years and prisoners will not be included in the study.
* Non English speaking potential participants who do not understand the requirements of the study will not be included.