cyrilzakka/clinical-trials huggingface dataset:
Case Series of New Alloplastic Bone Graft Material

A case series to compare the handling and effectiveness of two different treatment approaches using a new alloplastic bone graft material in ridge preservation compared to allograft existing historical data.


Eligibility Criteria:
Inclusion Criteria:

* Must have read, understood and signed a consent form.
* 18-75 years of age
* Diagnosis with a need of extraction of single tooth (with intact extraction socket at the time of extraction) with adjacent teeth present.

Exclusion Criteria:

* Active caries or endodontic lesions in adjacent teeth
* Any systemic disease or condition that would compromise the normal healing. (e.g., uncontrolled diabetes)
* Taking any medication known for gingival hyperplasia for past 3 months.
* Any systemic contraindications to surgery
* Subject smokes \> 10 cigarettes per day.
Trajectories of Chronic Multimorbidity Patterns in Older Patients

Following the MRisk-COVID project, MTOP (Multimorbidity Trajectories in Older Patients) study was developed. It is a retrospective observational study using Real World Data that aims to identify patterns of chronic multimorbidity in patients aged ≥65 years and their evolution and trajectories in the previous 10 years. The secondary objective is to identify the relationship between the trajectories of multimorbidity patterns in the previous 10 years and the severity of the infection by COVID-19.

Multimorbidity is associated with negative results and presents difficulties in clinical management. Recently, new methodologies are emerging based on the hypothesis that chronic conditions are associated in a non-random way forming multimorbidity patterns. However, there are few studies that study the temporal evolution and trajectories of these multimorbidity patterns, which could be associated with different prognoses and could allow better forecasting and planning. The primary objective of this analysis is to identify patterns of chronic multimorbidity in patients aged ≥65 years and their evolution and trajectories in the previous 10 years, using part of the MRisk-COVID project data. As a secondary objective, the investigators want to identify the relationship between the trajectories of multimorbidity patterns in the previous 10 years and the severity of the COVID-19 infection. This retrospective observational study has a historical cohort of 3958 patients ≥65 years of age suspected and confirmed of COVID-19 infection from February 1 to June 15, 2020 in the reference area of Parc Taulí University Hospital. The available data (real-world data) are socio-demographic and diagnostic variables provided by the Data Analytics Program for Research and Innovation in Health (PADRIS), which include sex, age and primary care diagnoses. To identify patterns of multimorbidity, the Clinical Classification Software, Chronic Condition Indicator, multiple correspondence analysis and cluster analysis using the fuzzy c-means algorithm will be used. Then, a clinical consensus process (Delphi-like) will be made of the clusters obtained. To identify the most probable trajectories along the three time points, each patient will be assigned to the cluster with the highest probability of membership. Descriptive and bivariate statistics will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Positive results of COVID-19 laboratory tests
* COVID-19 related clinical profile verified by healthcare professionals

Exclusion Criteria:

* Males \>90 years (re-identification risk)
Effects of OAGB and DJB-SG on 10-year and Lifetime Risks of MACE

Metabolic bariatric surgery (MBS) has demonstrated its efficacy in achieving sustainable weight loss and alleviating associated comorbidities. The primary objective of our investigation is to assess the long-term impact and sustainability of weight loss, the remission of T2D as well as risk prediction of cardiovascular events following MBS concerning one-anastomosis gastric bypass (OAGB) and duodenojejunal bypass with sleeve gastrectomy (DJB-SG).

Metabolic bariatric surgery (MBS) offers enduring weight reduction and alleviation of obesity-related comorbidities, including dyslipidemia, type 2 diabetes (T2D), hypertension (HTN), and major adverse cardiovascular events (MACE). Long-term data on one anastomosis gastric bypass (OAGB) and duodenal-jejunal bypass with sleeve gastrectomy (DJB-SG) is lacking, necessitating this investigation. In this multicenter prospectively-collected retrospective observational study, patients with complete follow-up data at various intervals up to 3 years after surgery were included in the final analysis. The study's primary focus was to evaluate the long-term safety, efficacy, and durability of OAGB and DJB-SG in promoting weight loss and T2D remission. Additionally, changes in 10-year and lifetime risks of MACE before and 3-year after surgery were assessed using the Taiwan MACE risk prediction model and the China-PAR project model based on Taiwan national electronic health records and a large Chinese participant dataset, respectively.

Hypothesis: This study contributes to providing valuable information in terms of the impacts of OAGB and DJB-SG on patients with obesity and associated diseases.

Eligibility Criteria:
Inclusion Criteria:

* Patients whose BMI≧37.5 kg/m2 or patients whose BMI≧32.5 kg/m2 and have concurrent high-risk comorbidities, such as hypertension, obstructive sleep apnea, HbA1c≧7.5% after anti-diabetic medication treatment, etc;
* The patients have been treated with lifestyle intervention, including increase in physical activity and change in diet, for more than 6 months;
* Age between 20 and 65 years old;
* Patients without other endocrinological causes that result in morbid obesity;
* Patients without substance use, alcohol use and other psychiatric disorders;
* The integrity of the patient's mental status is approved by the psychiatrist.

Exclusion Criteria:

* Patients who did not complete 3-year follow-up
* Patients who are not eligible for surgery
Salvage of Infected Cardiovascular Implantable Electronic Devices (CIED) by Localized High-dose Antibiotics

Following previous positive experience with regulated CITA-RNPT of infected CIEDs, we suggest increasing the number of recruited patients and that CITA-RNPT can be administered prophylactically to patients prior to replacement of previously treated CIEDs, immuno-compromised patients, and others.


Eligibility Criteria:
Inclusion Criteria:

* High-risk patients for CIED infections
* CIED infections

Exclusion Criteria:

* Systematic infection
DNI Values After Periodontal Treatment

The study included 70 systemically healthy individuals, as a test group of 35 patients with Stage 3, Grade A periodontitis and a control group of 35 individuals with no periodontal disease. Blood samples were taken for the examination of DNI, white blood cells (WBC), immature granulocytes (IG), procalcitonin, C-reactive protein (CRP), lymphocyte count and neutrophil count. For the patients with periodontitis, blood sample assays were repeated 3 months after NSPT.

The role of the Delta Neutrophil Index (DNI) in the pathogenesis and follow-up of periodontal disease has not been comprehensively documented. The study included 70 systemically healthy individuals, as a test group of 35 patients with Stage 3, Grade A periodontitis and a control group of 35 individuals with no periodontal disease. Blood samples were taken for the examination of DNI, white blood cells (WBC), immature granulocytes (IG), procalcitonin, C-reactive protein (CRP), lymphocyte count and neutrophil count. For the patients with periodontitis, blood sample assays were repeated 3 months after NSPT.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with periodontitis
* Patients have more than 20 teeth in the mouth
* Minimum age 18
* Maximum age 65

Exclusion Criteria:

* Patients with any systemic disease
* Active smokers
* Pregnant or breastfeeding
* Patients have used any antibiotic or anti-inflammatory drug in the last 6 months
* Patients have received any periodontal treatment in the last 6 months.
Study of Zatolmilast (BPN14770) in Participants With PPP2R5D Neurodevelopmental Disorder (Jordan's Syndrome [JS])

The primary objective of this study is to assess the safety and tolerability of BPN14770 in participants aged 9 to 45 years with JS.


Eligibility Criteria:
Inclusion Criteria:

1. Participant is aged 9 to 45 years, inclusive.
2. Participant has confirmed/documented history of PPP2R5D Neurodevelopmental Disorder.
3. Current treatment with no more than 3 prescribed psychotropic medications.
4. Participant has a parent, legal authorized guardian or consistent caregiver.

Exclusion Criteria:

1. Participant has body weight less than 25 kilograms (kg).
2. Clinically significant abnormalities, in the investigator's judgment, in safety laboratory tests, vital signs, or electrocardiogram (ECG), as measured during Screening.
3. Concurrent major psychiatric condition (e.g., Major Depressive Disorder, Schizophrenia or Bipolar Disorder) as diagnosed by the investigator. Participants with additional diagnosis of Autism Spectrum Disorder or Anxiety Disorder will be allowed.
4. Participant is planning to commence psychotherapy or cognitive behavior therapy (CBT) during the period of the study or had begun psychotherapy or CBT within 4 weeks prior to Screening.
The Impact of Psychological Interventions on Psychometric and Immunological Measures in Patients With Major Depression

The objective of this study is to compare the impact of i) Cognitive Behavioral Therapy (CBT) combined with exercise, ii)CBT combined with euthymic therapy, and iii) 'Cognitive Behavioral Analysis System of Psychotherapy' (CBASP) on psychometric and immunological measures in patients with major depression.

The interest of the investigation is to compare the impact of CBT combined with exercise, CBT combined with euthymic therapy and CBASP on depression and further psychopathological variables (assessed at 5 points).

Previous findings indicate increased concentration of pro-inflammatory cytokines in depression. A bidirectional relationship between depression and immunological alterations has been suggested: On the one hand pro-inflammatory cytokines may contribute to depression, on the other hand depression-linked changes (e.g. a reduction of activity, increased stress-sensitivity) may lead to increased secretion of pro-inflammatory cytokines. Therefore, this study is also supposed to investigate the influence of above mentioned interventions on pro-inflammatory cytokines. Using a waiting group, potential changes in psychometric and biological parameters without any intervention are controlled. Assessments take place at baseline, after 4 weeks of treatment, after 8 weeks of treatment, after 16 weeks of treatment and 6 months follow up.

200 patients with Major Depression (DSM IV, BDI II at baseline ≥18) will be included. Patients will be randomized and assigned to one of the 4 groups.

Eligibility Criteria:
Inclusion Criteria:

* patients with Major Depression (DSM IV), BDI \>=18
* age:18-65 years
* patients with and without antidepressive medication
* comorbidity with other psychiatric disorders is permitted, as far as depressive symptoms are dominating

Exclusion Criteria:

* current psychotherapy
* psychotic disorder
* serious drug-addiction
* drugs which seriously affect immune status (except contraceptives) or central nervous system functions (except antidepressants)
* infections during the last 2 weeks
* injuries during the last 2 weeks
* neurological disorders
* diseases which affect immune status or central nervous system functions (e.g. rheumatoid arthritis, CVD,etc.)
Impact of Three Different Education Methods on Oral Hygiene

In the present study, 144 children (72 males and 72 females), whose ages ranged between 8-13, were divided into 12 equal experimental groups according to their ages and gender. They were all considered to have poor hygiene. Only one out of the three different education methods (brochure, model or video) was applied to each group. The percentage change in PI, GI, BOP and theoretical test points from the baseline to the 6th months were evaluated.

Aim: The aim the present study was to evaluate the impact of three different education methods on the oral hygiene levels of school children using clinical and theoretical findings.

Methods: In the present study, 144 children (72 males and 72 females), whose ages ranged between 8-13, were divided into 12 equal experimental groups according to their ages and gender. They were all considered to have poor hygiene. Only one out of the three different education methods (brochure, model or video) was applied to each group. The percentage change in PI, GI, BOP and theoretical test points from the baseline to the 6th months were evaluated. The data was statistically analysed by using Kolmogorov-Smirnov and One-way ANOVA tests.

Eligibility Criteria:
Inclusion Criteria:

* According to the Simplified Oral Hygiene Index, the patients having the score of 2 and over were accepted.

Exclusion Criteria:

* According to the Simplified Oral Hygiene Index, the patients having the score under 2 were not included in the study
Phase II Randomized Study of Alendronate Sodium for Osteopenia in Patients With Gaucher's Disease

OBJECTIVES:

I. Determine the efficacy of alendronate sodium in treating osteopenia (generalized bone density and focal bone lesions) in patients with Gaucher's disease.

PROTOCOL OUTLINE:

This is a randomized, double blind, placebo controlled study.

All patients receive oral calcium carbonate and cholecalciferol daily. Patients are randomized to receive oral alendronate sodium or placebo daily for 24 months.

Patients are followed every 6 months for 2 years.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of type 1 Gaucher's disease enzymatically proven to have acid beta glucosidase deficiency

Must have been on stable dose (8-60 U/kg/every 2 weeks) of alglucerase enzyme therapy (Cerezyme or Ceredase) for at least 24 months

Lumbar spine bone density below the mean for age, sex, and race

--Prior/Concurrent Therapy--

At least 6 months since prior medications that directly affect skeletal metabolism including, but not limited to, bisphosphonates, calcitonin, parathyroid hormone, or estrogen

--Patient Characteristics--

Renal: No chronic renal failure; No recurrent renal stones

Esophageal: No history of dysphagia; No frequent heartburn; No esophagitis requiring treatment

Other: No untreated hyperthyroidism or hypothyroidism; No concurrent hyperparathyroidism; No concurrent malignancy; No history of alcohol or drug abuse; Not pregnant; Negative pregnancy test; Fertile patients must use effective contraception
Pilot Study to Determine the Effectiveness of Antimicrobial Healthcare Worker's (HCW) Hands and Clothing

This is a pilot study to determine the effectiveness of antimicrobial scrubs on bacterial burden of HCW's hands and clothing in a clinical setting.

Goals of the pilot study:

* Compare CFU counts on antimicrobial vs standard scrubs in a clinical setting
* Assess CFU counts on the hands of HCWs wearing antimicrobial vs non-antimicrobial scrubs
* Assess HCW hand hygiene compliance during the study protocol
* Correlate device associated infection rates during protocol to historical controls
* Assess feasibility of applying protocol to a longer,12-24 month, prospective crossover-trial to definitively study and assess the impact of antimicrobial scrubs on HCW apparel and hand colonization, control of multi-drug resistance organisms, hand hygiene compliance, and device associated hospital acquired infection rates.

II. Design

Cross-over trial in an ICU or Hospital Ward

III. Outcome Measures

1. CFU count on participants

   1. Hands
   2. Scrubs
   3. Antimicrobial scrubs vs standard scrubs
2. Hand Hygiene Compliance
3. Device associated nosocomial infections rates

Eligibility Criteria:
Inclusion Criteria:

* HCWs in the MRICU

Exclusion Criteria:

* Under the age of 18 who is not a healthcare worker in the MRICU
COVID-19 and Pregnancy Outcomes

This is a multicenter prospective study that aims to investigate the clinical impact of SARS-CoV-2 infection in pregnant women, pregnancy outcomes and perinatal transmission.

This is a cohort study of pregnant women confirmed positive for SARS-CoV-2 infection. Data will be collected in Portuguese maternities that agreed to collaborate in this study.

Pregnant women are tested during hospital admission by using nasopharyngeal/oral swabs for SARS-CoV-2 RT PCR as part of a universal testing policy. Maternal demographic data (age, comorbidities, parity, smoking habits), COVID-19 related data (symptoms, diagnostic tests, therapy used and ICU admission), gestational age at SARS-CoV-2 confirmed infection, pregnancy outcomes (gestational complications, gestational age at birth, mode of delivery) and neonatal outcome (birthweight and Apgar score, RT PCR neonate results) and breastfeeding strategies will be evaluated.

Eligibility Criteria:
Inclusion Criteria: Pregnant women infected with Sars-Cov-2. Delivery at Portuguese maternities.

Exclusion Criteria: RT PCR SARS-CoV-2 negative.

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A Study of the Safety and Pharmacokinetics of Apixaban Versus Vitamin K Antagonist (VKA) or Low Molecular Weight Heparin (LMWH) in Pediatric Subjects With Congenital or Acquired Heart Disease Requiring Anticoagulation

To investigate the safety and pharmacokinetics of apixaban in children with congenital or acquired heart disease who have a need for anticoagulation.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Males and Females, 28 days to \< 18 years of age, inclusive
* Congenital or acquired heart diseases requiring chronic anticoagulation for thromboprophylaxis (eg, single ventricle physiology including all 3 stages of palliation, dilated cardiomyopathy, Kawasaki disease with coronary aneurysms, and pulmonary hypertension)
* Eligible participants include those who newly start anticoagulants and those who are currently on VKA or LMWH or other anticoagulants for thromboprophylaxis
* Able to tolerate enteral medication \[eg, by mouth, nasogastric tube, or gastric tube\]
* Participants 28 days to \< 3 months must be able to tolerate oral/nasogastric tube (NGT)/gastric tube (GT) feeds for at least 5 days prior to randomization

Exclusion Criteria:

* Recent thromboembolic events less than 6 months prior to enrollment
* Weight \< 3 kg
* Use of aggressive life-saving therapies such as ventricular assist devices (VAD) or extracorporeal membrane oxygenation (ECMO) at the time of enrollment
* Artificial heart valves and mechanical heart valves
* Known inherited bleeding disorder or coagulopathy (e.g. hemophilia, von Willebrand disease, etc.)
* Active bleeding at the time of enrollment
* Any major bleeding other than perioperative in the preceding 3 months
* Known intracranial congenital vascular malformation or tumor
* Confirmed diagnosis of a GI ulcer
* Known antiphospholipid syndrome (APS).

Other protocol defined inclusion/exclusion criteria apply
The Effects of Light Therapy on Circadian Rhythms, Sleep, and Mood in Postpartum Depression

The proposed study aims to establish the feasibility of light therapy for postpartum depression delivered via Re-Timer, demonstrate its preliminary efficacy, and illuminate relationships between circadian shifts and mood changes using a novel, home-based circadian biomarker assessment paradigm (salivary dim light melatonin onset; DLMO).


Eligibility Criteria:
Inclusion Criteria:

* Within 6 months postpartum
* Meet DSM-V diagnostic criteria for MDD
* Score ≥ 20 on the Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder version (SIGH-SAD).

Exclusion Criteria:

* current diagnosis of bipolar disorder, posttraumatic stress disorder, schizophrenia or psychosis, dissociative disorders, eating disorder, obsessive-compulsive disorder, somatic symptom and related disorders, substance use disorder, panic disorder, agoraphobia per DSM-V
* past history of mania/hypomania,
* chronic medical conditions associated with depression (e.g., thyroid conditions)
* ocular or retinal pathology
* history of seizures or epilepsy
* color blindness
* Lupus
* currently taking an antibiotic, medication that contains hydrochlorothiazide, or isotretinoin (Accutane).
Zinc Supplementation to Improve Prognosis in Patients With Compensated Advanced Chronic Liver Disease.

Zinc homeostasis could play a role in advanced chronic liver disease (cACLD) and its supplementation has been linked with improvement in liver function, decrease of hepatic complications and reduction in hepatocellular carcinoma (HCC) incidence. cACLD encompasses a heterogeneous group of patients with a variable risk of clinically significant portal hypertension (CSPH) and clinical events. The ANTICIPATE model is a validated model for stratifying these risks. Our aim is to demonstrate that the administration of zinc can reduce the rate and risk of presenting clinical events (first decompensation, HCC, death and liver transplantation). This study protocol describes an ongoing phase III, national, multicentre, randomized, double-blind clinical trial that will enroll 300 patients to receive either the trial treatment (zinc acexamate) or placebo. An inclusion period of 42 months is planned, with a minimal duration of follow up of 2 years. Our principal hypothesis is that zinc could modify the natural history of cACLD patients, with an overall improvement in prognosis


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes with diagnosed compensated advanced chronic liver disease (cACLD) determined by hepatic stiffness on transient elastography \>15 kPa.
* Age between 18 and 80 years, inclusive.
* Absence of prior or current decompensation.
* For women of childbearing age, a possible pregnancy will be ruled out by a pregnancy test prior to the start of the study. Following the test, the woman must use an effective contraceptive method during sexual intercourse (see Appendix I) in the days leading up to the start of treatment, and continue to use it throughout the treatment period, as well as for several days after its completion.
* Signing of informed consent.

Exclusion Criteria:

* History or current presence of hepatocellular carcinoma.
* Concomitant systemic disease with a short-term poor prognosis.
* Pregnancy, breastfeeding, or refusal to use contraceptive measures during participation in the study.
* Patients with compensated advanced chronic liver disease (cACLD) due to hepatitis B virus (HBV) under antiviral treatment, and those with cACLD due to hepatitis C virus (HCV) cured with antiviral treatment.