cyrilzakka/clinical-trials huggingface dataset:
Comparative Study Between Porcine and Autologous Cortical Plates

The aim of this study is to evaluate the outcome of three-dimensional bone regeneration procedures using thin cortical porcine xenograft plates in combination with autogenous bone chips compared with thin autogenous cortical plates and autogenous bone chips.

Materials and methods: 16 patients referred for implant placement and with insufficient bucco-lingual (BL) alveolar bone width (\<4 mm) were included in the study. Patients received autogenous cortical plates (ACP) of either porcine xenogeneic (XCP). The aforementioned groups were compared in regards to bone augmentation using General Estimating Equations (GEE) and logistic regression. Demographic data, trabecular bone density, graft site, postoperative pain, and time consuming were also analyzed

Eligibility Criteria:
Inclusion Criteria:

- Patients were enrolled in the study on the basis of having insufficient bone height (\<6mm), width (\<3mm) or both, in either maxilla or mandible

Exclusion Criteria:

Patients with severe systemic disease (American Society of Anesthesiology III or IV) were excluded from the study.

In addition, patients who were pregnant, or patients with diseases affecting bone, such as:Paget's disease, osteomalacia, diabetes, vitamin D deficiency, alcoholism, hyperthyroidism cancer or osteoporosis as well as those on medications that might affect bone metabolism, such as bisphosphonates, corticosteroids or antiepileptic medicaments were also excluded from the study.
Radiofrequency Ablation Assisted Hepatectomy Versus Hepatectomy Alone for Advanced Hepatocellular Carcinoma

RFA has become a standard method in the treatment of small HCC(≤2 cm) due to its ease of use, safety, cost-effectiveness, and minimal invasiveness. It can ablated and blocked the small vessels while destroyed the tumor cell in situ. Surgical resection is the most widely accepted treatment for the patients with advanced hepatocellular carcinoma in the Asian countries. But the effectiveness of hepatectomy was depressed because of the high recurrence rate. The spreading of the cancer cell along the portal vein or the hepatic vein system during the operation account for the tumor recurrence. Using RFA to ablate and block the small vessels around the tumor before resection will reduce the spreading of the cancer cell. Investigators hypothesized that the RFA assisted hepatectomy might result in lower recurrence rate than hepatectomy alone in the treatment of advanced HCC. Thus, the purpose of this study was to prospectively compare the effects of RFA assisted hepatectomy with hepatectomy alone for the treatment of advanced HCC.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of HCC confirmed at our hospital.
2. Intrahepatic tumor count no higher than 3 and a minimum tumor diameter \> 3 cm, but no more than 8cm.
3. Liver function of Child-Pugh Class A or B.
4. Tumors lacked intrahepatic and extrahepatic metastasis.
5. Tumors had not invaded the portal vein, the hepatic vein trunk or the secondary branches.
6. Indocyanine green retention at 15 minutes (ICG-15) of \<10%.
7. No evidence of coagulopathy: platelet count \> 50 × 109/L and a prolonged prothrombin time of \< 5 seconds.
8. No other anti-tumor therapy received before the treatment. -

Exclusion Criteria:

1. Patients met the inclusion criteria but declined to participate.
2. Patients with severe portal hypertension, a history of esophageal variceal hemorrhage, severe hypersplenism syndrome, or refractory ascites.
3. Patients whose permanent pathology after treatment suggested metastatic liver cancer or primary liver cancer of another tissue type.
VIRTUAL COMMUNITY for PREGNANT WOMEN

The study aimed to investigate the effect of exclusive peer-to-peer virtual support on pregnant women's well-being including physical symptoms, depression, social support, maternal attachment, and pregnancy adaptation.

The pregnancy period is marked by not only the joy and excitement of bonding with her baby but also dramatic changes in her body. The Internet's convenience and anonymity provide great possibilities for pregnant women to create a social network for sharing personal stories, seeking information and asking questions, and expressing own emotions and concerns.

Although health-related online communities are emerging rapidly around the globe, little is known about the impact of a virtual peer community on pregnant women's well-being.

The study enrolled 138 pregnant women, who were assigned to either the experimental or control groups. After obtaining informed consent from participants, we asked them to fill out the baseline questionnaires (Time 1). The first and second follow-ups (Times 2 and 3) were conducted at 22-24 and 36-38 weeks of pregnancy, respectively. Participants in the experimental group received ordinary prenatal care in addition to virtual community participation, and those in the control group received only ordinary prenatal care.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women were older than 20 years old
2. Had at least 9 years of education.

Exclusion Criteria:

1. Had complications in this pregnancy
2. Had underlying medical problems with pregnancy.
Operations Research to Address Unmet Need for Contraception in the Postpartum Period in Sylhet District, Bangladesh

The proposed operations research study is designed to evaluate a package of family planning services and related behavior change interventions aimed at addressing the unmet need for family planning in postpartum women, integrated with an ongoing maternal and newborn health program, and to assess the program's impact (1) on knowledge of healthy fertility practices, (2) on contraceptive use prevalence in women during the postpartum period, (3) on postpartum birth spacing, and (4) to examine the feasibility and sustainability of the proposed integrated service delivery approach. The study will have a quasi-experimental design, with evaluation primarily through household surveys in four intervention unions and four comparison unions (unions are lowest local government entities with an average population of about 20,000) in rural Sylhet District, Bangladesh.

The specific objectives of this operations research are:

1. Integrated Family Planning/Maternal Neonatal Health Intervention: To develop and test an integrated Family Planning and Maternal and Neonatal Health (FP/MNH) service delivery approach in the Bangladesh setting, building on the ongoing Projahnmo study. Intervention activities will include behaviour change communications on healthy timing and spacing of pregnancy, couples counseling, social networking and expansion of contraceptive options for postpartum women, including provision of oral contraceptive pills and condoms in the home.
2. Integrated Service Delivery Approach: To assess the strengths and limitations of integrating family planning into an ongoing community-based maternal and newborn care program.

   1. To compare the quality of counseling provided by CHWs in the integrated (MNH+FP) intervention arm versus regular (MNH) control arm in Sylhet district, Bangladesh
   2. To assess the knowledge of CHWs providing integrated (MNH+FP) counseling in the intervention arm versus CHWs providing regular MNH counseling in the control arm in Sylhet district, Bangladesh
   3. To determine factors that affect the quality of care provided by CHWs in both the intervention and control arms in Sylhet district, Bangladesh

Eligibility Criteria:
Inclusion Criteria:

* Unions have been selected by the following criteria: 1) currently implementing Projahnmo MNH program; 2) Similar demographics between intervention and comparison unions; 3) Input from local health officials regarding the most suitable Unions to work in; and 4) Capacity and demonstrated willingness of health workers at the Union level based in Union Health and Family Welfare Centers to collaborate with the project and work to achieve its objectives.

Recently delivered women Infants Community providers Husbands Mothers-in-law Community providers

Exclusion Criteria:

* Unions not adhering to inclusion criteria.
* Women not of reproductive age (unless they fall under other category)
* Infants- over age 1
Outcomes and Prognostic Factors in Hepatopancreatoduodenectomy

1. In biliary tract malignancies, achieving a microscopically clear resection margin (R0) is considered the only treatment for a cure.
2. Hepatopancreatoduodenectomy(HPD) has been considered a surgical option for patients with extensive bile duct or gallbladder cancer to achieve an R0 resection.
3. The associated high morbidity and mortality rates have prevented HPD from becoming a standard surgical procedure worldwide.
4. Over the past few decades, the understanding of the bile duct anatomy has significantly improved, and many methods have been developed to assess liver function and future remnant liver volume.
5. We aimed to evaluate the short- and long-term outcomes of HPD and to assess risk factors associated with survival, early recurrence, and major complications to better evaluate the potential of the procedure as a standard treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients who received hepatopancreatoduodenectomy between January 2000 and December 2023.

Exclusion Criteria:

* Patients who had R2 resection
Virtual Reality Behavioral Activation: An Intervention for Major Depressive Disorder

The primary purpose of this study is to test the safety and feasibility of virtual reality (VR) technology in the use of behavioral activation (BA) as a treatment for major depressive disorder (MDD). The secondary purpose of this study is to examine whether any evidence of clinical efficacy exists for VR delivered BA.

This is a treatment development trial. Participants will be randomly assigned to BA in VR, BA in real-life, or a waitlist control group. The former two groups will follow a BA protocol developed for primary care settings over a four-week treatment period. This study is taking place over Zoom, due to COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* Patient must meet DSM V criteria for MDD
* Patient must be at least 18 years of age
* Patient must be English speaking

Exclusion Criteria:

* Substance Use Disorders in past year
* Any psychosis or bipolar I disorder
* Any seizure in the last 6 months or untreated epilepsy
* Current nonsuicidal self-injury or parasuicidal behavior
* Current suicidal urges and intent
DYNAMic Renal Assessment: NOvel Methods to Assess KIDNEY Functional Reserve

This is a feasibility study to assess new, more practical ways of measuring renal reserve.

Quantification of glomerular filtration rate (GFR) over time is the standard assessment of kidney function. In clinical practice, the endogenous marker, 'serum creatinine' concentration, is used as a static assessment of kidney function to estimate GFR. However, serum creatinine fails to increase until at least 50% of kidney tissue is lost,\[2\] thus is an inadequate indicator of early CKD.

GFR like many other physiological processes is not static and augments temporarily to stimuli such as exercise and protein intake, by up to 25% from baseline in healthy individuals.\[3\] Similar to cardiac function stress tests which predict adverse outcomes, inability to respond to renal stressors or 'reduced renal reserve' has been demonstrated to occur prior to development of CKD (e.g. in patients with diabetes and previous acute kidney injury (AKI)) and is associated with vulnerability to future AKI, despite the presence of apparently normal kidney function measured by serum creatinine concentration.\[4\] Renal reserve is lost with progressive CKD,\[4\] and has also been demonstrated to relate to severity of histological lesions.\[5\]

Current measurements of renal reserve (stimulated increase in GFR due to augmented renal blood flow above basal fasting values) involve administration of a compound that is freely filtered by the glomerulus, unaffected by tubular function and is physiologically inert, with assessment before and after an oral protein load or amino acid infusion which induces arterial vasodilation, increasing renal blood flow and GFR

The study proposes a comparison of two novel methods of 'dynamic renal function testing' with renal reserve testing.

Eligibility Criteria:
Inclusion:

Patients with sickle cell nephropathy, diagnosed clinically or histologically. Sickle Cell patients will be confirmed Hb SS and eGFR (CKD-EPI) ≥ 135 ml/min/1.73m2 OR Previous living kidney donation Age ≥ 4No contraindication or known allergy to any trial medications. Willing and able to provide written informed consent

Exclusion:

Aged \< 40 Unable or unwilling to provide informed consent Breastfeeding or pregnant women Patients involved in other interventional research studies.
Home Care Medication Management Program for the Frail Elderly

The purpose of this study is to determine whether a home care medication management program which includes nurse coordination and use of the MD.2 medication-dispensing machine will affect older adults' health outcomes, satisfaction, use of health care services, and health care costs over a one year period. The investigators propose a longitudinal three group repeated measures design, enrolling, and randomly assigning, clients who are discharged from a home health care agency with documented problems in medication management. One group will receive the MD.2 medication dispensing device and nurse coordination, the second group will receive a Medplanner: a simple box that has separate compartments for individual medication times over the course of a week plus nurse coordination, and the final group will receive Usual Care.

The study hypotheses are the following:

H1: With respect to health status outcomes, the MD.2 group will exhibit a more positive trajectory in physical and mental health status, functional status, cognitive status and depressive symptoms over the course of a year than will the Medplanner Group.

H2: With respect to health status outcomes, the Medplanner Group will exhibit a more positive trajectory in physical and mental health status, functional status, cognitive status and depressive symptoms over the course of a year than will the Usual Care Group.

H3: The rate of hospitalization, hospital days and emergency department visits will be significantly lower for the MD.2 Group as compared to the Medplanner Group.

H4: The rate of hospitalization, hospital days and emergency department visits will be significantly lower for the Medplanner Group as compared to the Usual Care Group.

H5: The nursing home admission rate will be significantly lower for the MD.2 Group as compared to the Medplanner Group.

H6: The nursing home admission rate will be significantly lower for the Medplanner Group as compared to the Usual Care Group.

H7: The total cost of care will be significantly lower for the MD.2 Group as compared to the Medplanner Group.

H8: The total cost of care will be significantly lower for the Medplanner Group as compared to The Usual Care Group.

H9: There will be incremental savings in terms of costs per quality adjusted life year (QALY) gained in the MD.2 group compared with the Medplanner Group.

H10: There will be incremental savings in terms of costs per QALY gained in the Medplanner group compared with the Usual Care Group.


Eligibility Criteria:
Inclusion Criteria:

* Age 60 and older
* Medicare Primary Payer
* Impaired Medication Management ability as indicated by a score of 1 or higher on OASIS discharge assessment item M0780
* Impaired Cognitive Functioning but able to follow directions with prompting as indicated by a score of 1 or 2 on OASIS discharge assessment item M0560
* working telephone line
* Discharge from home health care

Exclusion Criteria:

* Not English speaking
* Terminal diagnosis or hospice care
* Use of other device for medications
* Medicare via managed care
* Use of private home care agency for medication management
VZV PCR Sampling Validation Study

This study will evaluate and compare various methods for collecting lesion samples from subjects with clinically diagnosed herpes zoster for the laboratory confirmation of herpes zoster. The samples will be tested by polymerase chain reaction (PCR) to detect VZV DNA. Multiple samples from each type of herpes zoster lesion will be collected in order to determine whether the analysis of duplicate samples enhances the sensitivity of VZV DNA detection for the diagnosis of herpes zoster. In addition, blood will be collected for the evaluation of VZV immunity at the time of the initial herpes zoster sample collection (after herpes zoster has been clinically diagnosed) and one month later in order to establish the range of cellular and humoral immune responses during natural herpes zoster in adults ≥50 years old.

This non-prophylactic, non-therapeutic study involves NO treatment of study participants.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed with herpes zoster by the investigator including the presence of a typical herpes zoster rash.
* A male or female aged 50 years or older at the time of the subject's enrolment.
* Written informed consent obtained from the subject.
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.

Exclusion Criteria:

* Any malignancy for which the subject is receiving active treatment, or any haematological malignancy.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccination, including corticosteroids, except inhaled and topical steroids are allowed.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
* Previous vaccination against herpes zoster.
* Confirmed or suspected immunosuppression, based on medical history or physical examination (no laboratory testing required).
* A family history of congenital or hereditary immunodeficiency.
* History of or chronic alcohol or drug abuse.
Rhythmic Reading Training: Comparing the Rhythmic and Visual Contributions to Reading Improvement

The main objective of the study is to evaluate the specific effect of the sub-components of the reading training program Rhythmic Reading Training (RRT) on reading speed and accuracy in a sample of Italian students with developmental dyslexia (DD). More precisely, in order to better understand the neuropsychological mechanisms involved in reading improvements following RRT, the specific contribution of the visual component of the training (presence of a visual cue) will be investigated in a study with between-groups design.


Eligibility Criteria:
Inclusion Criteria:

* having been diagnosed with DD (ICD-10 code: F81.0) on the basis of standard inclusion and exclusion criteria (ICD-10: World Health Organization, 1992) and of the diagnosis procedure followed in the Italian practice

Exclusion Criteria:

* presence of comorbidity with other neuropsychiatric or psychopathological conditions
* having been involved in previous reading intervention programs in the previous 3 months
Population Pharmacokinetics of Anti-tuberculosis Drugs in Children With Tuberculosis

This study is based on the hypothesis that the pharmacokinetics of anti-tuberculosis drugs in TB children are different from adults. The investigators aim to study the population pharmacokinetics of children receiving the anti-tuberculsis drugs for treatment of TB. In this study, the investigators will detect drug concentration in plasma by using residual blood samples of blood gas analysis and other clinical tests and employ computers for constructing population pharmacokinetic models. In addition, the investigators also want to correlate use of anti-tuberculsis drugs with treatment effectiveness and incidence of adverse effects in children. This novel knowledge will allow better and more rational approaches to the treatment of TB in children. It will also set the foundation for further studies to improve anti-tuberculosis drug therapies for children.

1.Establish population pharmacokinetic (PPK) models of each anti-tuberculsis drug in children by nonlinear mixed effect modeling (NONMEM).

1. At different timepoint after anti-tuberculsis drug administration, plasma samples of 100 children will be collected from neonatal intensive care unit (NICU) and pneumology department for each drug. The clinical information includes demography, medication, concentration data, blood biochemical parameters and so on .
2. Plasma samples will be tested by high performance liquid chromatography (HPLC).
3. PPK models of anti-tuberculsis drug will be established by NONMEM program.
4. The reliability and stability of the PPK model will be evaluated by 1000 times of Bootstrap procedure and normalized predictive distribution error (NPDE).

2.Evaluation of the clinical feasibility and safety of individualized dosing.

1. According the results of PPK models, the investigators will use dosages recommended in models to cure TB children in prospective studies. For anti-tuberculsis drug, 50 children will be collected.
2. The investigators will compare the therapeutic effects and safety between children with conventional therapies and children with individualized therapies, including proportions of children with effective drug concentration, improvement speed of of children, liver and kidney functions of of children, adverse reactions of drugs and so on.

Eligibility Criteria:
Inclusion Criteria:

* Children (0-18 years old) with anti-tuberculosis therapy against TB.
* The anti-tuberculsis therapy includes drugs commonly used in children infectious diseases
* Informed consent signed by the parents and/or guardians.

Exclusion Criteria:

* Anti-tuberculosis drugs aren't involved in the therapies of children.
* It is unable to provide complete medical records or the current condition cannot accept the study process.
* Patients are allergic to anti-tuberculsis drugs.
* Parents and/or guardians do not agree to participate in this study.