cyrilzakka/clinical-trials huggingface dataset:
Tenting Screws Versus Autogenous Ring Block Grafts During Horizontal Ridge Augmentation

After administering local anesthesia,. A full-thickness mucoperiosteal flap will be incised and be reflected to expose the alveolar bone. The dimensions of the defect will be measured using a periodontal probe to determine the appropriate size of the block graft or the quantity of particle bone graft required.

In the non screw group, the blocks will be adapted to fit the recipient sites and secured to the alveolar bone using titanium bone fixation screws. Following the placement of the blocks, bovine particles will be applied over the graft and into any remaining gaps between the block and the recipient site, a resorbable collagen membrane (CM) will be shaped and placed over the graft and fixed using subperiosteal sutures.

In Tenting screw cases, the screws will be placed in suitable positions and depths, blocks will be crushed into particulates which will then be mixed with equal amount of bovine particles. the mixture will be applied to the recipient site all around the tenting screws a resorbable collagen membrane (CM) will be shaped and placed over the graft and fixed using subperiosteal sutures.

The flaps will then be sutured


Eligibility Criteria:
Inclusion Criteria:

* Patient has anterior maxillary horizontal defect less than 4mm in the alveolar ridge and (classified as class III or IV atrophy according to Cawood and Howell classification). (Cawood \& Howell, 1988require horizontal bone augmentation in anterior maxilla before dental implant placement and in need of an implant-supported restoration in at least one site,
* Adult individuals aged 18 years or older
* Satisfactory oral hygiene,
* No previous history of bone augmentation procedures at the site to be treated in the study,
* The ability to comprehend and provide informed consent.

Exclusion Criteria:

* Uncontrolled systemic disorders,
* Prior irradiation in the head and neck region,
* Immunosuppression or compromised immune system,
* Oral disorders such as lichen planus, ongoing or recent treatment with intravenous amino- bisphosphonates, untreated periodontitis,
* Poor oral hygiene and motivation,
* Parafunctional habits, pregnancy or lactation,
* Substance abuse involving drugs or alcohol, psychiatric disorders, a history (within the last 3 months) of regular use of smokeless chewing tobacco, smoking a pipe, cigar, or more than 10 cigarettes per day, acute or chronic infection or inflammation in the area, or
* Extraction with less than 3 months of healing.
Catheter Dysfunction Rate in Patients Undergoing Kidney Replacement Therapy. Evaluation of the Safety and Efficacy of Anti-reflux Valves Without Heparin Lock Solution

Catheter dysfunction and infections are the most common complications observed among patients with dialysis catheters for long-term dialysis ( CDLD ) . They are causing a worsening of the morbidity and mortality of patients , loss of quality of renal replacement therapy , a reduction in the duration of catheterization , as well as increased spending related to health care.

The use of anti- reflux ( Tego ® , ICU Medical , USA, distributed by the Laboratory Hemotech , FRANCE ) valves reduces the rate of dysfunction and infections CDLD( catheters for long-term dialysis ). Unpublished preliminary data suggest that these valves allow parallel use of interdialytic saline locks without increasing the risk of dysfunction. This strategy would therefore achieve significant savings usual interdialytic CDLD( catheters for long-term dialysis )locks ( including heparin) whose use is not devoid of potentially serious adverse events and whose health care costs have increased dramatically in recent years . Moreover, this would also produce savings in fibrinolytic treatment.

A randomized controlled trial is needed to assess the effectiveness of TEGO ® valves in combination with saline locks on the risk of dysfunction CDLD(catheters for long-term dialysis ) .

Interventional prospective, multicenter (8 dialysis units) , randomized, controlled, open study. Two strategies are compared in a parallel plan : a "valve arm " (implementation of TEGO ® valve associated with interdialytic saline locks) and a "control arm" ( standard care ). Rate of dialysis session with dysfunctions during the first six months of the study is the primary endpoint. It will be analyzed " per protocol ". The total duration of patient follow-up is 12 months.

After the first 6 months, patients in the "valve arm" retain the same type of care until the end of the study. The control patients continue to receive the usual concentrated heparin locks . The secondary endpoints of the study will be analyzed to 12 months. Training of health care teams is expected before the start of the study .

Eligibility Criteria:
Inclusion Criteria:

* Haemodialysis patients

Exclusion Criteria:

-
The Impact of Online Educator Mircoskill Training and Parent Microskill Training on Student Sexual-Health Related Outcomes

The goal of this clinical trial is to evaluate the impact of SkillTalk among educators, parents, and students. The main question\[s\] it aims to answer are:

* What is the impact of SkillTalk on student sexual-health related outcomes?
* What is the impact of SkillTalk on educator microskills?

Educator participants will use an online microskills training platform for one week. Parent participants will be asked to use a parent-specific online microskills training platform for one week. Youth participants will not be asked to do anything outside of "business as usual." Researchers will compare the treatment groups to the control groups to measure the impact of SkillTalk.


Eligibility Criteria:
Inclusion Criteria for Educators:

* Have fewer than three years teaching
* Teach youth in a class with at least 8 students
* Be able to obtain supervisor's or administration permission before beginning study
* Agree to be in compliance with district/school regulations about teaching sexual health and participating in a research study
* Agree to administer the assent/consent forms and student surveys.\\

Inclusion Criteria for Students:

* Being in class of teacher who has agreed to participate
* Parental consent
* Assent to participate

Inclusion Criteria for Parents:

* Be the parent/guardian of a youth who has assented to participate
* Consent to their youth's participation
* Consent to view SkillTalk Parent site
* Need to speak English or Spanish
* Access to internet
Treatment of Sebaceous Hyperplasia with PDL and Nd:YAG Versus Erbium:YAG: a Randomized Controlled Trial

The purpose of this study is to compare treatment of sebaceous hyperplasia with pulsed dye laser (PDL) plus neodymium doped yttrium aluminum garnet laser (Nd:YAG) versus erbium doped yttrium aluminum garnet (erbium:YAG) laser versus electrodesiccation and curettage (ED\&C).

This is a randomized clinical trial. Approximately 18 participants will enrolled. Each participant will have their sebaceous hyperplasia lesions randomized to receive either Erbium:YAG, PDL plus Nd:YAG, or ED\&C treatment. Solitary lesions will be randomized to a group, thus, a patient may receive all three treatments, each on different lesions. Lesions will be treated twice, 2-6 weeks after the first treatment. Lesion size and count will be measured before treatment and at follow-up 4-12 weeks after the first treatment. This study is a pilot study designed to determine the feasibility of these procedures.

Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.


Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years of age
2. Receiving cosmetic treatment for sebaceous hyperplasia
3. In good general health as assessed by the investigator
4. Participants must have the ability to understand and the willingness to sign a written informed consent prior to registration on study

Exclusion Criteria:

1. Patient pregnant or nursing
2. Patient with history of poor wound healing that would result in hypertrophic scar or keloid at the discretion of the physician
3. Patient with recent sun exposure that would result in pigment changes at the discretion of the physician
4. Subject unwilling to sign an IRB approved consent form
5. Participants who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function are not eligible
An Open-label Study of the Effects of Elagolix in Adult Premenopausal Females

This is an open-label Phase 1 study in healthy premenopausal females evaluating the effects of different dosing regimens of elagolix on ovarian activity, ovulation, and ovarian reserve and to assess the effect of elagolix on selected endocrine/hormone levels.

This is an open-label, multiple-dose, Phase 1 study in premenopausal subjects aged 18 years to 40 years, with a history of regular menstrual cycles (24 to 32 days long) and no evidence of significant gynecological disorders. The objective of the study is to determine the effects of different dosing regimens of elagolix on ovulation, ovarian activity, and ovarian reserve. The study consists of 3 periods: a Screening Period of up to 50 days prior to the first dose, a Treatment Period of 3 months duration (Cycles 1-3), and a Follow-up Period of up to 60 days. During the Screening and Treatment menstrual cycles, serial transvaginal ultrasounds and determination of serum levels of luteinizing hormone, follicle-stimulating hormone, estradiol, progesterone, and inhibin B will be performed three times weekly. Subjects will maintain a daily diary of uterine bleeding. Pregnancy testing will be performed frequently throughout the study. Subjects will be required to use nonhormonal dual contraception consistently during the study, and will be counseled on appropriate and effective forms of birth control to promote pregnancy prevention.

Eligibility Criteria:
Inclusion Criteria:

- Premenopausal female, between 18 and 40 years of age, inclusive - History of regular menstrual cycles - Endocrine and ultrasonographic evidence of ovulation and normal ovulatory cycle during the screening period - Follicle-stimulating hormone level of \<35 mIU/mL - Agrees to use required birth control methods during the entire length of participation in the study

Exclusion Criteria:

- Screening ultrasound results show a clinically significant gynecological disorder - Surgical history of hysterectomy without oophorectomy, unilateral or bilateral oophorectomy, removal of ovarian cysts - Less than 6 months postpartum or post-lactation at the start of study drug dosing - Pregnant or breast feeding or is planning a pregnancy within the next 12 months - Testosterone concentration \>120 ng/dL at screening
Autologous Platelet Rich Plasma Combined to Hyaluronic Acid Obtained With Regen-Kit BCT-HA in Aesthetic Medicine

The aim of this prospective study is to assess the efficacy of autologous Platelet Rich Plasma combined with Hyaluronic Acid prepared with RegenKit-BCT HA Cellular Matrix on skin rejuvenation. Thirty-one patients were included and received three PRP-AH injection sessions 4 weeks apart into the cheeks. The outcomes were assessed at baseline, 1, 3 and 6 months after the last injection session. Safety was assessed by reported adverse event analysis.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 40 years with chronological aging
* Completed informed consent form

Exclusion Criteria:

* Pregnancy or breastfeeding
* Patients younger than 40 years
* Use of product or treatment aimed to improve skin rejuvenation over the last six months before study start,
* patients with known hypersensitivity to HA,
* patients with eczema flare-up,
* patients with active skin disorder infection including herpes virus infection, active hepatitis or human infection virus infection.
* Dermatological diseases affecting the face
* Auto-immune disease such as Hashimoto, rheumatoid arthritis.
* Malignancy with or without metastatic disease
* Chemotherapy
* Anticoagulant therapy
Effects of 5-Methyltetrahydrofolate and Vitamin B12 Supplemetation on Red Cell Membrane in Children With Cystic Fibrosis

The purpose of this study is to determine whether 5 - methyltetrahydrofolate and vitamin B12 supplementation can ameliorate cell plasma membrane features in pediatric patients with cystic fibrosis

Cystic fibrosis (CF) is one of the most common fatal autosomal recessive disorders in the Caucasian population caused by mutations of gene for the cystic fibrosis transmembrane conductance regulator (CFTR). New experimental therapeutic strategies for CF propose a diet supplementation to affect the plasma membrane fluidity and to modulate the cellular amplified inflammatory response in CF target organs. Red blood cells (RBCs) were used to investigate plasma membrane, because RBCs share lipid, protein composition and organization with other cell types.

Eligibility Criteria:
Inclusion Criteria:

* cystic fibrosis

Exclusion Criteria:

* diabetes
* chronic infections of the airways
* regular antibiotics intake
Study of Niacin and Rosiglitazone in Dysmetabolic Dyslipidemia

Lipid abnormalities in people with the Metabolic Syndrome (the Insulin Resistance Syndrome) are characterized by elevations in triglycerides and LDL cholesterol; low levels of HDL cholesterol; and small, dense LDL particles. Statins generally do not change LDL particle size, so often fenofibrate is added. This combination may still not be sufficient. Niacin is a common third drug added to the treatment regimen, but niacin can increase insulin resistance. This study compares niacin as a third drug to rosiglitazone, an insulin sensitizer.

The Metabolic Syndrome is characterized by an atherogenic dyslipidemia consisting of hypertriglyceridemia, modest elevations of LDL cholesterol, low levels of HDL cholesterol, and LDL phenotype pattern B (small, dense LDL particles). Statins are first line therapy, and reduce LDL cholesterol levels without affecting LDL particle size. Fenofibrate addresses the triglycerides, HDL cholesterol levels, and LDL phenotype, so is recommended as second level therapy. The third element is niacin, but for insulin resistant patients, a question has been whether niacin might be exacerbating the underlying pathophysiology of Metabolic Syndrome patients. In SNARED, niacin was compared to the insulin sensitizer rosiglitazone in study subjects already on statin and fenofibrate.

All volunteers participating in SNARED exhibit LDL phenotype pattern B despite statin therapy at the time of recruitment. Comparisons of LDL phenotype at baseline are to be compared to measurements made after 4 months of statin + fenofibrate. If the LDL phenotype converts to pattern A (large LDL particles), this is a study endpoint. Otherwise, study subjcts are randomized to receive statin+fenofibrate+niacin, or statin+fenofibrate+rosiglitazone for six months, at which time lipid phenotype will again be determined..

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years Fasting triglycerides \> 100 mg/dL Fasting plasma glucose 110-128 mg/dL Non-pattern A LDL phenotype

Exclusion Criteria:

* Overt diabetes mellitus Current therapy with hypoglycemic agents Secondary causes of dyslipidemia (e.g. HRT, thyroid disease) Serum creatinine \> 2.5 mg/dL or nephrotic syndrome AST/ALT \> 3X upper limits of normal Known gallbladder disease History of gout or hyperuricemia History of peptic ulcer disease Hypersensitivity or intolerance to any of the study drugs Women who are pregnant or nursing
The Patient Experience of a Paramedic-Pharmacist Referral Pathway for Clinical Medication Reviews

This study seeks to understand how patients feel about their medicines before and after receiving a clinical medication review.

Falls in people aged 65 years and over are a common reason for calling the emergency ambulance service. Falls can be serious, with about 1 in 20 people having to be taken to hospital because they have been injured. Thankfully, in more than 4 out of 10 cases, people are not seriously injured and can be left at home. However, it is important that the reason for the fall is found and future falls are prevented where possible.

Yorkshire Ambulance Service can already make a referral to another local service to get specialist practical help for falls prevention when people are left at home after a fall. Research has shown that the safe use of medicines can prevent future falls, but that did not form. Now a new service has been set up for Yorkshire Ambulance Service to refer patients to the Leeds GP Confederation. A pharmacist working in the patients GP surgery will undertake a review of the patient's use of their medicines.

We would like to find out about how patients feel about using their medicines before and after the medicines review by a pharmacist. We would also like to know how they feel about the medicines review itself, to help decide whether this scheme should continue or be expanded to other areas. To do this, we are going to send a questionnaire to patients who receive a medicines review. The questionnaire will be sent by post, take about 10 minutes to fill out and include a stamped addressed envelope so people who take part will not have to pay for postage.

Eligibility Criteria:
Inclusion Criteria:

* Received a pharmacist-led clinical medication review following a falls referral made by a paramedic from Yorkshire Ambulance
* Registered with a GP in the Leeds area
* Has capacity to consent to take part in the study

Exclusion Criteria:

* Did not receive a pharmacist-led clinical medication review after a Yorkshire Ambulance Service paramedic made a falls referral
* Not registered with a GP in the Leeds area
* Does not have capacity to consent to take part in the study
Adult Autoimmune Myopathies (MAIA)

This study corresponds to a monocentric prospective cohort of adult patients presenting a suspicion of idiopathic inflammatory myopathy. It will allows the constitution of an organized collection of longitudinal clinical data as well as collection of biological samples, including blood sample, urine, stool and muscle specimen.


Eligibility Criteria:
Inclusion Criteria:

* Clinical suspicion of Adult Inflammatory Myopathy
* Social security affiliation

Exclusion Criteria:

* Pregnant and lactating women
* Patients unable to consent
* Patients refusing to participate in the research.
* Patients under legal protection
Enhanced Virologic Monitoring for Pregnant and Postpartum Women With HIV

The goal of this study is to learn about supporting pregnant and postpartum women living with HIV with treatment adherence. The investigators will conduct a pilot study of an intervention that includes peer counseling about viral load levels and rapid delivery of viral load results. The investigators will evaluate the feasibility of the intervention, and will assess whether it improves viral suppression 6 months following the intervention, compared to historical controls.

The investigators will examine the use of more frequent virologic monitoring with enhanced communication around low-level viremia as a strategy to identify and support pregnant and postpartum women at risk of virologic failure. Virologic monitoring itself can reinforce adherence in stable patients, and more frequent monitoring can detect potential adherence challenges early. Notably, low-level viremia is a strong predictor of subsequent virologic failure, and the lowest level associated with perinatal transmission is not known.

The pilot study will run for 6 months at 4 Ministry of Health facilities in Kisumu County, Kenya; 275 participants will be enrolled. Prior to the pilot study, 125 controls will be enrolled prospectively, and 150 controls will be abstracted from records from the prior year.

Eligibility Criteria:
Inclusion Criteria:

* Women living with HIV
* On antiretroviral treatment
* Either pregnant in the 3rd trimester, OR, postpartum within 6 months of delivery

Exclusion Criteria:

* n/a
The INSPIRE-Lung Study

LungTalk and leveraging Facebook-targeted Advertisement (FBTA) addresses the call to develop and test multi-level, cancer communication interventions using innovative methods and designs. The study's long term goal is to increase lung cancer screening uptake among appropriate, high-risk individuals nationwide.


Eligibility Criteria:
Inclusion Criteria:

* ≥20-pack-year smoking history;
* Individuals who currently smoke or quit smoking within the past 15 years

Exclusion Criteria:

* Previously undergone LDCT for early detection of lung cancer, have a lung nodule or nodules that are currently being followed
* Has ever been diagnosed with lung cancer
* Individuals with impaired decision-making (because our primary outcome is decision-making, we will not include individuals with impaired decision-making)
Expanded Access to Upadacitinib

This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to upadacitinib prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility Criteria:
Inclusion Criteria:

- The participant must not be eligible for upadacitinib clinical trial.
Laparoscopic Tubal Preservation Surgery

Traditionally, salpingectomy has been the standard procedure for managing ectopic pregnancy. We would like to evaluate the safety and efficacy of laparoscopic tubal preservation surgery in treating ectopic pregnancies (salpingostomy or salpingotomy) while preserving the fertility outcome of the patients, as well as to identify the factors predicting the presence of persistent ectopic pregnancy after the surgery.

All surgically-treated ectopic pregnancies in women aged 20 and above between 01 January 2009 and 31 December 2016 were identified. Cases receiving laparoscopic salpingostomy or laparoscopic salpingotomy were extracted from the database, patient characteristics and surgical outcomes (changes of serumβ-hcg, presence of persistent ectopic pregnancy and subsequent management, subsequent pregnancy) were reviewed from their medical records. Univariate and multivariate logistic regression analysis were employed to predict the presence of persistent ectopic pregnancy after laparoscopic tubal preservation surgery.

Eligibility Criteria:
Inclusion Criteria:

* women who had laparoscopic tubal preservation surgery (including salpingostomy and salpingotomy) for ectopic pregnancy between January 2009 and November 2016

Exclusion Criteria:

* women with ectopic pregnancy at sites other than fallopian tube (i.e. interstitial, ovary, abdomen)
A Study to Evaluate the Photoirritation Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy Volunteers

This Phase 1 study is designed to determine the photoirritation potential of PEP005 Gel, 0.01% when application is followed by light exposure.


Eligibility Criteria:
Inclusion Criteria:

* healthy males or females;
* in the case of females of childbearing potential, must be using effective contraception and must provide a negative pregnancy test;
* must read, understand and provide signed informed consent.

Exclusion Criteria:

* are not willing to refrain from using topical/systemic analgesics within 72 hours prior to and during the study;
* are using systemic/locally-acting medications during the study and within 2 weeks prior to the beginning of the study;
* are using systemic/locally-acting anti-inflammatories during the study and within 72 hours prior to the beginning of the study;
* have participated in any clinical testing of an investigational drug within 28 days or any clinical patch application within 14 days prior to enrollment or are currently participating in any clinical testing.