cyrilzakka/clinical-trials huggingface dataset:
Study of the Integration Success of an Implant System With a Novel Abutment Attachment Design in Immediate Loading Cases

Integration success rates measured by lack of implant mobility and crestal bone regression measurement will be higher for the experimental implant design than for the control implants.

In this study patients are randomized to receive either the experimental implant system or the control Nanotite Certain Tapered (standard abutment connection) and assessed for integration success measured by cumulative success rate in cases that are loaded immediately

Eligibility Criteria:
Inclusion Criteria:

* patients of either sex and older than 18 years of age
* patients needing at least one dental implant to treat partial edentulism
* patients physically able to tolerate surgical and restorative dental procedures
* patients agreeing to all protocol visits

Exclusion Criteria:

* patients with infection or severe inflammation at the intended treatment sites
* patients smoking greater than 10 cigarettes per day
* patients with uncontrolled diabetes mellitus
* patients with uncontrolled metabolic diseases
* patients who received radiation treatment to the head in the past 12 months
* patients needing bone grafting at the intended treatment sites
* patients known to be pregnant at screening visit
* patients with para-functional habits like bruxing and clenching
Three Types of Nucleotide/Nucleoside Analogues Therapy in Patients With Chronic Hepatitis b

This study is to investigate the clinical efficacy and safety of three types of nucleotide/nucleoside analogues in treatment of chronic hepatitis b

Chronic hepatitis b (CHB) remains a serious public health problem in China. Nucleotide/nucleoside analogues are used for anti-virus treatment in these patients. Entecavir, Tenofovir Disoproxil Fumarate and Tenofovir Alafenamide are first line drug in China. But there still lacks of data of Tenofovir Alafenamide in treatment of CHB. This study is to investigate the clinical efficacy and safety of three types of nucleotide/nucleoside analogues in treatment of CHB.

Eligibility Criteria:
Inclusion Criteria:

1. Positive hepatitis b surface antigen or hepatitis b virus DNA \> 0.5 year;
2. Age from 18 to 65 years old;
3. HBeAg-positive: HBV DNA≥20000IU/ml，HBeAg-negative: HBV DNA≥2000IU/ml；
4. ALT≥2×ULN；
5. Do not receive nucleotide/nucleoside analogues treatment in the past half year.

Exclusion Criteria:

1. Other active liver diseases;
2. Hepatocellular carcinoma or other malignancy;
3. Pregnancy or lactation;
4. Human immunodeficiency virus infection or congenital immune deficiency diseases;
5. Severe diabetes, autoimmune diseases;
6. Other important organ dysfunctions;
7. Using glucocorticoid;
8. Patients can not follow-up;
9. Investigator considering inappropriate.
To Evaluate Adenosine Monophosphate and Allergen Challenge in Allergic Rhinitis

Allergic rhinitis is a common condition characterize by inflammation of the upper airways. Third generation antihistamines have been demonstrated effective in the treatment of this condition. Allergen challenge can be use to assess the effects of drugs in allergic rhinitis, adenosine monophosphate may also be used as a means to investigate these effects but as yet its effects have yet to be compared to allergen challenge. We intend to compare the effects of levocetirizine at a single dose of 5mg on allergen and AMP challenge compared to placebo in a double blind cross-over study. The study will include 20 patients with allergic rhinitis. Each patient will have allergen and AMP challenge on placebo and active treatment. The primary outcome variable will be the change in concentration of AMP/Allergen required to produce a 20% drop in nasal flow as manifest by peak nasal inspiratory flow. A 1 doubling dose change in concentration of challenge medium to cause a 20% drop in nasal flow will be deemed significant. We will also measure time to recovery after both challenges. AMP challenge is a safe alternative to allergen challenge and does not have the risk of anaphylaxis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 16-75
* Patients with persistent rhinitis must be skin prick positive to house dust mite with perennial symptoms
* Patients with seasonal rhinitis should be skin prick positive to grass/tree pollen with seasonal symptoms
* Concomitant asthma is permitted in those with rhinitis if FEV1 \>60%
* No recent exacerbations of asthma or chest infections if asthmatic
* Able to perform all of the techniques necessary to carry out challenge testing
* Must be compliant to study medication
* Must give informed consent

Exclusion Criteria:

* Male or female outwith the above age range
* Negative skin prick testing
* Patients with concomitant asthma with FEV1 less than 60% predicted
* Patients with asthma with recent chest infection or exacerbation
* Pregnant females, those at risk of becoming pregnant or breast feeding. Females must be on adequate contraception for the whole study period
Analysis of the Availability of the Treatments for ACE-I and ARB-induced Angioedema

Specific treatments for angiotensin-converting-enzyme inhibitor (ACE-I) and angiotensin-receptor-blocker (ARB)-induced angioedema exist. Early access to these treatments is challenging because they are expensive and have short shelf lives making it illusory that all emergency department (ED) stock them. The aim of this retrospective study was to define, for each patient with a confirmed ACE-I or ARB-induced angioedema, at which step of the care, the specific treatment was administered. The second objective was to analyse the availability of these treatment in the area around Lyon, France and the factors that may influence it.


Eligibility Criteria:
Inclusion Criteria:

* Every patient followed for the first time in our reference center for severe confirmed ACE-I or ARB-induced angioedema. Data were analyzed from patients attended either in a specialized angioedema consultation or during a hospitalization in our intensive care unit.
* Severe attack was defined either by its localization over the shoulder or by an severe abdominal attack.

Exclusion Criteria:

- Patients which received no specific treatment (icatibant, C1-inhibitor concentrate) were excluded.
Efficacy of Er: YSGG Laser in Treatment of Peri-implantitis

This study will be carried out to evaluate the efficacy of Er: YSGG laser on oral biofilm removal from implant surface in various peri-implant defect morphology in the treatment of peri-implantitis as a primary objective.

To assess the morphological changes and the biological response (biocompatibility) of implant surface after Er: YSGG laser therapy through Profilometer analysis and cell culture process to detect attachment, differentiation, and mineralization of Isolated rat Bone Marrow Mesenchymal stem cells (rBMMSCs) respectively as secondary objectives.

This study will be carried out to evaluate the efficacy of Er: YSGG laser on oral biofilm removal from implant surface in various peri-implant defect morphology in the treatment of peri-implantitis as a primary objective.

To assess the morphological changes and the biological response (biocompatibility) of implant surface after Er: YSGG laser therapy through Profilometer analysis and cell culture process to detect attachment, differentiation, and mineralization of Isolated rat Bone Marrow Mesenchymal stem cells (rBMMSCs) respectively as secondary objectives.

The study was designed as an Ex Vivo study. Four periodontally and systemically healthy volunteers of both gender are included in this study for the formation of in vivo plaque biofilm. Each volunteer will wear a hard resin splint carrying six rough (machined implant; 3.3mm diameter, 8mm length) for 4 days to accumulate dental plaque naturally on the titanium surfaces of the implants.

Therefore, 24 implants will be assessed for Er: YSGG laser therapy in different bone defect simulators.

Eligibility Criteria:
Inclusion Criteria:

* Sex: female or male.
* Age: 25 - 55 years.
* Medically controlled according to medical coding of review of systems (ROS)

Exclusion Criteria:

* Tobacco smoking for at least 6 months before the study enrollment

  * Participants with ill-fitting restorations in both upper first molars that affect the stability of the stent.
  * Participants not following oral hygiene instructions.
  * Participants on dental treatment during the study period.
  * Participants with a history of drug administration
  * Vulnerable group.
  * Participants with long-term mouthwash administration.
Is COVID-19 Transmitted Through Human Milk? Implications for Breastfeeding and Human Milk Banking-Study 1c

This will be a prospective observational study of lactating mothers who are planning to, have scheduled or have received vaccination against SARS-COV-2 (COVID-19 vaccine). Mothers may have delivered at Mount Sinai Hospital or may be from the general public recruited by social media or word of mouth. As the study participants will be lactating mothers, they will not be under the care of the investigators. Due to lack of information, we are unsure of an appropriate sample size but envision we will recruit at least 10 women each immunized with the approved mRNA vaccines (e.g. Pfizer-BioNTech and Moderna COVID-19 vaccines) and in the future at least two other vaccines (e.g. Oxford-AstraZeneca) as they are approved and become available. Milk samples will be analyzed for the presence of antibody to SARS-CoV-2 using the Anti-SARS-CoV-2 ELISA (IgG and IgA). These analyses will be conducted in the Department of Microbiology at Sinai Health following validation of the procedures in human milk.


Eligibility Criteria:
Inclusion Criteria:

* lactating birthing persons from the general public or Sinai Health System

Exclusion Criteria:

* None
Personalizing Treatment Delivery

Anxiety and anxiety-related disorders frequently co-occur with alcohol use problems resulting in an enormous humanitarian and economic cost to society. The proposed research will use digital technology to examine person-specific risk factors predicting problematic alcohol use in individuals vulnerable to anxiety and anxiety-related disorders and will use this information to design a personalized intervention for individuals seeking psychological treatment. Results from this research will integrate output from novel and innovative digital technology methods into psychotherapy, advancing research on personalized treatment and prevention efforts.


Eligibility Criteria:
Inclusion Criteria:

* Access to a smart phone
* Between 18 and 65 years
* Clinically significant anxiety or trauma-related symptoms
* Alcohol use problems
* Interest in telehealth counseling
* Anticipated New Jersey or New York residence for the duration of the study

Exclusion Criteria:

* Currently receiving counseling
* Psychiatric medication that is not currently at a stable dose (or is not anticipated to remain at a stable dose for the duration of the study)
* Demonstrated indicators of more intensive or acute care
* Temporary residence within the state of New Jersey or New York or out-of-state residence from the state of New Jersey or New York
Integrating Pediatric TB Services Into Child Healthcare Services in Africa

Under-diagnosis of TB in children is a critical gap to address. The INPUT study is a multinational stepped-wedge cluster-randomized intervention study aiming to assess the effect of integrating TB services into child healthcare services on TB diagnosis capacities in children under 5 years of age.

Study clusters (district-level hospitals and their health centers) will start under standard-of-care and transition to the intervention at randomly assigned time points.

In this study two strategies will be compared: i) The standard of care, offering pediatric TB services based on current routine approach; ii) The intervention, with pediatric TB services integrated into child healthcare services.

The primary objective will be to assess the effect of the intervention compared to standard of care on the proportion of TB cases diagnosed among children \<5 years old (that is the number of children who are clinically or bacteriologically diagnosed with TB over the total number of children attending the child healthcare services). Secondary objectives are detailed in the protocol.

Study sites will include six hospital in each participating country (Cameroon and Kenya) along with selected attached health centers.

The study population will be children aged less than five years of age with a presumptive diagnosis of TB.

Study enrollment will start in March 2019, last enrollments until July 2020 and follow up will be completed by August 2021.

Eligibility Criteria:
Inclusion Criteria:

* Children \< 5 years old.
* TB diagnosis investigations initiated.
* Other infectious diseases are not suspected or have already been ruled out.
* Commitment to take treatment in the clinic of enrolment or another INPUT study site.
* Parental/caregiver consent for the child to participate in the study.

Exclusion Criteria:

* Children who are TB contacts but without symptoms or signs of active TB
Neoadjuvant Immunotherapy for T4 dMMR Colon Cancer

Due to dMMR colon cancer patients respond poorly to conventional chemotherapy, but immunotherapy can significantly improve the pCR in this group of patients, this study intends to explore whether neoadjuvant immunotherapy can improve the R0 resection rate with preservation of adjacent organs in T4 colon cancer patients with dMMR.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-75 years;
2. ECOG score 0-2;
3. Adenocarcinoma confirmed by pathology and dMMR confirmed by IHC or PCR;
4. Tumor located in cecum, ascending colon, transverse colon and sigmoid colon;
5. Patients with clinical stage cT4: (1) Loss of space between tumor and adjacent organs or invasion of adjacent organs as assessed by enhanced CT; (2) R0 resection cannot achieve according to intraoperative exploration;
6. No evidence of distant metastasis;
7. Newly treated patients who have not received treatment including chemotherapy and surgery;
8. Liver, kidney and other organs have good function and can tolerate chemotherapy and surgery;
9. Patients and family members can understand the study protocol, voluntarily participate in the study and sign informed consent.

Exclusion Criteria:

1. A history of other malignant tumors (other than cured basal cell carcinoma, cervical carcinoma in situ, surgically treated localized prostate cancer, or surgically resected breast ductal carcinoma in situ) within the past 5 years;
2. Complicated with intestinal obstruction, intestinal perforation, gastrointestinal bleeding and other patients requiring emergency surgery; pregnant or lactating women;
3. Patients with a history of severe mental illness, immune disease, hormone medication;
4. Patients contraindicated by immunotherapy or surgery;
5. Participated in other clinical researchers in the past 3 months;
6. Any other circumstances that the investigator considers inappropriate for inclusion.
Gore Tex Implants in the Treatment of Atrophic Rhinitis

This is a retrospective study, involving patients with atrophic rhinitis, that underwent Gore tex® implants in the nasal fossa.

The Fetid Rhinitis or Atrophic Ozena is a chronic illness characterized by yellowish secretion in the initial phase and the other phases with fetid crusts and atrophy of the mucous bone covering. Diverse theories exist that try to explain the appearance of this pathology, such as: hereditary factors, immunological alterations, viral infection and nutritional lack. Currently, its etiology remains unknown. As there isn't any ideal treatment already established, this technique improves the options of treatment.

All patients have improved after the procedure.

Data about 5 patients that underwent surgery to implant polytetrafluoroethylene in the nasal fossa was collect. The symptoms and complications were described.

Eligibility Criteria:
Inclusion Criteria:

* Symptoms of atrophic rhinitis, with previous clinical treatment without good results

Exclusion Criteria:

* Patients with mental illness
Comparison of Sun Protection Factor 30 Persistence Between Inorganic and Organic Sunscreen in Swimmer

Prolonged sunlight exposure in swimming athletes can cause various changes in the skin; among them is sunburn. The use of sunscreen can reduce sunburn effectively. However, various types of physical activity that can trigger sweating, friction, washing with water, or sun exposure after sunscreen use can interfere with its effectiveness in the form of a decreased SPF level. The purpose of this study is to determine and compare the persistence of organic and inorganic sun protection factor 30 (SPF 30) sunscreens after 1.5 hours of swimming.


Eligibility Criteria:
Inclusion Criteria:

* Female or male swimming athletes aged 18-40 years.
* Practice swimming at least 3 times a week with a duration of 1.5-2 hours per practice in the morning or afternoon.
* Willing to be the subject of research by signing the consent.
* Do not have skin diseases.
* Do not have a history of allergies to sunscreens.

Exclusion Criteria:

* Existence of skin lesion in the test area.
* In the treatment of phototherapy.
* Using drugs with photosensitivity side effects.
* History of skin malignancy, history of photosensitivity reactions or history of disease affected by UV rays.
* Exposure to direct sunlight to the test area 24 hours before the study and during the study period.
* Absence of erythema response 24 hours after the radiation test.
* Erythema occurs in the entire test area box 24 hours after the radiation test.
Comparison of Three Calcium Supplements

The study was conducted to investigate the metabolic effects of three different calcium compounds in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* age 18 - 40 years

Exclusion Criteria:

* diseases of the gastrointestinal tract
* pregnancy
* the intake of any medication (e. g. for thyroid gland)
* intake of dietary supplements
Nasal vs. Oral Intubation for Neonates Requiring Cardiac Surgery

Often, infants struggle to feed orally after surgery for congenital heart disease and may require supplemental feeding interventions at discharge. In this study, the investigators prospectively randomize infants to oral or nasal endotracheal intubation for surgery and assess postoperative feeding success.

Patients who require cardiac surgery in the neonatal period frequently encounter difficulties reaching full volume oral feeds. These difficulties are related to developmental features, perioperative events, and post-operative oral aversion symptoms. Patients who struggle with oral feeding require longer hospitalizations and frequently require invasive devices for stable nutrition at discharge. The investigators hypothesize that nasal intubation for neonatal cardiac surgery may reduce time to full oral feeds and decrease the proportion of patients requiring discharge feeding tubes.

This is a single-center, prospective randomized control trial of patients less than 2 weeks of age who undergo endotracheal intubation at the time of cardiac surgery. The investigators exclude patients who were \<37 weeks corrected gestational age (GA) at surgery, had orofacial or gastrointestinal anomalies, required \>5 days of intubation before surgery, or required ECMO or \>5 minutes of CPR at any time during the hospitalization. Patients are randomized to nasal (NI) or oral intubation (OI) by a trained pediatric cardiac anesthesiologist at the time of their surgery.

Infants are followed post-operatively until the time of discharge and otherwise receive routine care in the intensive care unit and acute cardiology service. Information regarding feeding milestones is obtained from the electronic medical record.

Eligibility Criteria:
Inclusion Criteria:

* Infants who require surgery for congenital heart disease before 2 weeks of age

Exclusion Criteria:

* \< 37 weeks estimated gestational age at the time of surgery
* Orofacial or gastrointestinal anomalies
* Devastating neurologic injury or malformation
* Intubation \> 5 days prior to surgery
* \> 5 minutes of CPR or ECMO at any time
Comparison of Functional Outcome Between BQT and SBHT ACL Reconstruction

ACL rupture has a high morbidity in productive-age population. The increasing incidence and proper management has become a point of interest in the musculoskeletal sport injury. Choosing the best graft has become the main focus in searching for a better outcome regarding ACL reconstruction in these patient population. Currently, single bundle hamstring tendon (SBHT) autograft was preferred in Asian population compared to bone quadriceps tendon (BQT) autograft. However, there are some problems such as smaller size, as well as diameter, of SBHT. This study is focused on evaluation of the clinical outcome between BQT and SBHT in arthroscopic-assisted ACL reconstruction patients.

In this prospective cohort study, 30 subjects were divided into 2 groups (BQT and SBHT). Sampling was taken between February 2016-2017 (1 year) in one orthopaedic center. The instruments used for evaluation are rolimeter and PRO questionnaires (IKDC, Tegner-Lysholm, and KOOS) with data mining between 1 month, 3 months, and 6 months post operation.

To obtain a valid and accountable research data, the investigators collected the information based on 2 parameters and then crosschecked the results.

After clinical data was obtained, the investigators translate the results into a statistical data using SPSS ver.24 and simplified the data for national registry and academic purposes.

According to previous studies, and research hypothesis, functional outcome of patient undergoing arthroscopic-assisted ACL reconstruction is better in BQT group compared to SBHT group, both in subjective and objective parameters given.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral, total rupture of ACL
* Procedure performed by the same surgeon
* Age of subjects between 15-40 years old

Exclusion Criteria:

* Multiligamentous injury
* Bilateral ACL ruptures
* Ligamentous laxity
* Prior knee ligamentous surgery
Pseudoxanthoma Elasticum (PXE) Natural History Biomarkers in PXE Individuals and Their Biological Non-PXE Siblings

This PXE biomarker study aims to characterize the levels of inorganic pyrophosphate (PPi), pyridoxal 5´-phosphate (PLP), and other biomarkers relevant to PXE and ectopic calcification in both PXE patients and their biological siblings who are PXE carriers or normal non-PXE individuals.

This non-interventional PXE study is designed to assess differences in circulation levels of selective biomarkers related to PXE and tissue-nonspecific alkaline phosphatase (TNAP) inhibition, between PXE patients, PXE carriers, and non-PXE normal individuals.

Eligibility Criteria:
Inclusion Criteria:

* Male or female participants aged 18 to 75 years
* Participants (approximately 1 carrier and 1 normal to match proband)

  * Confirmed PXE participants: index PXE/proband with established PXE and ABCC6 mutations identified
  * PXE carrier participants: biological sibling of the PXE index case and confirmed as PXE carrier
  * Non-PXE normal participants: biological sibling of PXE index case and confirmed as non-PXE normal

Exclusion Criteria:

* Unconfirmed ABCC6 mutation status
* Use of bisphosphonate in the preceding 12 months and during the study
* Use of Vitamin B6 and/or Vitamin D supplement in the preceding 1 month and during the study (if the total Vitamin B6 supplementation is \>5 mg/day)
* Recent initiation or dose change of Vitamin D and/or multivitamin supplement in the preceding 1 month and during the study
* Bone fracture within 3 months prior to Screening or active bone disease (excluding osteopenia or osteoporosis)
* History of hyperparathyroidism
* History of moderate to severe renal impairment
* History of hypophosphatasia
* Known history of uncorrected abnormality in calcium (Ca), phosphate, alkaline phosphatase (ALP) or parathyroid hormone
* Other significant condition (medical, psychiatric, social, or medication) that, in the judgment of the Investigator, would prevent full participation or would be inappropriate for the study