cyrilzakka/clinical-trials huggingface dataset:
Nipple Neurotization

A retrospective chart review will be conducted to identify patients receiving breast reconstruction and simultaneous breast neurotization. Their reconstructed breasts will be included as study group. Patients receiving breast reconstruction without neurotization will be included as negative control group. Their contralateral normal breasts in the study and the negative control group will be included as positive control. Patients' demographic data, their breast cancer treatment parameters, such as the staging, previous radiotherapy history, postmastectomy radiotherapy, neoadjuvant and adjuvant chemotherapy will be included. The reconstruction results will be evaluated as well.

Statistics Data will be analyzed using graphing and statistical analysis software. Independent t test will be applied to calculate continuous variables in demographic values, while Chi-square will be applied to calculate categorical variables such as postoperative complications. A probability of less than 0.05 will be considered significant.

Potential risks: No

Confidentiality:

All the patient identifiable information, which includes name, chart number and birthday, involved in the study will be strictly confidential.


Eligibility Criteria:
Inclusion Criteria:

* patients who received breast reconstruction and neurotization from July 2019 to August 2022 from a single breast reconstruction surgeon.
* patients who received breast reconstruction without neurotization were included as the non-neurotized group.

Exclusion Criteria:

* patients unable to complete the follow-up were excluded from the study
Induction Chemotherapy in Young Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

1. To see the effect if a combination of induction chemotherapy followed by chemoradiotherapy works in treating children with advanced nasopharyngeal carcinoma(NPC).

This phase II trial is studying how well radiation therapy and chemotherapy work in treating young patients with newly diagnosed nasopharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin and fluorouracil and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type).
* Original clinical staged as T4N0-3 M0 or any T、N3M0（according to the American Joint Committee on Cancer(AJCC) 7th edition）
* No evidence of distant metastasis (M0).
* Age ≤ 18 years old.
* Satisfactory performance status: Karnofsky scale (KPS) \> 70.
* Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
* Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) \<1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.
* Adequate renal function: creatinine clearance ≥60 ml/min.
* Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria:

* WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
* Age \>18 years.
* Treatment with palliative intent.
* Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
* Pregnancy or lactation.
* History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
* Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
* Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×ULN), and emotional disturbance.
Effects of Iron and/or Zinc Supplementation in Mexican School Children Exposed to Lead

Lead is negatively linked to nutritional status, behavior and cognition in children. Despite extensive knowledge of its toxicity and efforts to reduce exposure, lead continues to be a problem in developed and developing countries. When lead exposure is unavoidable due to its pervasive nature, effective means of protecting or disrupting that exposure need to be developed. Nutritional interventions are one such option. We conducted a 2x2 factorial, placebo-controlled trial of 6-month iron and zinc supplementation among lead-exposed children in Torreón, Mexico (altitude 1060 m). Nine schools were selected based on proximity to a lead smelter and first-graders were individually randomized to daily treatment with 30 mg iron, 30 mg zinc, both, or placebo. In addition to biochemical indicators, cognitive functions and behavior were evaluated at baseline, after the 6-month supplementation period, and again after another 6 months (without supplementation).

At baseline, 602 children ages 6.2-8.5 years were enrolled.

We conducted a 2x2 factorial, placebo-controlled trial of 6-month iron and zinc supplementation among lead-exposed children in Torreón, Mexico (altitude 1060 m) to test the hypothesis that supplementation with iron, zinc or both will reduce blood lead concentrations of the children and improve their cognition and behavior. Nine schools were selected based on proximity to a lead smelter and first-graders were individually randomized to daily treatment with 30 mg iron, 30 mg zinc, both, or placebo. In addition to biochemical indicators (blood lead, serum ferritin, CRP, serum zinc, urinary arsenic concentrations), cognitive functions and behavior were measured. Assessments were conducted at three time points: at baseline, after the 6 month treatment, and again after another 6 months without treatment. At baseline, 602 children ages 6.2-8.5 years were enrolled.

Eligibility Criteria:
Inclusion Criteria:

* 1st grade child

Exclusion Criteria:

* Blood lead concentration =\>45 ug/dL
* Hemoglobin concentration \< 9 g/dL
Assess the Long-term Effectiveness and Safety of Amevive (Alefacept) in Subjects With Moderate to Severe Chronic Plaque Psoriasis

The study is a prospective, multi-centre, observational study designed to assess the long-term effectiveness and safety of alefacept in subjects with moderate to severe chronic plaque psoriasis.

Study includes a bio-marker sub-study to determine differences in responders vs. non-responders. Additional consent is required for the sub-study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with moderate to severe chronic plaque psoriasis who receive a new prescription for alefacept

Exclusion Criteria:

* Subjects with a contraindication to alefacept
* Subjects with a history of cancer except for adequately treated basal cell carcinoma (maximum of 2 lesions)
* Subjects with any active cancer, including skin cancer
* Subjects having a serious local infection (eg. cellulitis, abscess) or serious systemic infection (eg. pneumonia, septicemia, tuberculosis), within the 3 months prior to the first dose of alefacept.
* Subjects known to be infected with the AIDS virus
Comparative Study of the Outcome of Partial and Full Pulpotomy in Irreversible Pulpits

This study aims at comparing the outcome of partial pulpotomy and full pulpotomy in the management of carious pulp exposures in permanent teeth with a clinical diagnosis of irreversible pulpits. The primary outcome is resolution of symptoms and the secondary outcome is clinical and radiographic normality at 1 and 2 years follow up.

The study design will be a double blind randomized clinical trial.

Aim: to compare the outcome of partial and full pulpotomy in managing carious pulp exposures in mature permanent teeth with symptoms of irreversible pulpitis

Methods: Assuming a 10% difference in the success rate in favor of pulpotomy, with 80% power and accounting for possible 10% attrition, the minimum sample size required is estimated to be 80 teeth in 80 patients in every arm.

Patients referred to the postgraduate Endodontic clinic for management of deep carious lesions with symptoms of irreversible pulpits will be assessed for inclusion in the study according to preset inclusion criteria. After a written informed consent baseline demographics of patients and teeth will be recorded.

Pulpotomy (partial or full using block randomization) will be performed under aseptic procedures and the tooth will be permanently restored. Post operative baseline radiographs will be taken.

Primary outcome will be assessed after 48 hours. secondary outcome will be assessed at 6 months, 1 year and 2 years post operatively.

Data of outcome and effect of preoperative and intraoperative variables on the outcome will be compared statistically using appropriate tests

Eligibility Criteria:
Inclusion Criteria:

* Mature permanent tooth
* Deep caries extending more than two thirds of dentine or exposing the pulp
* Tooth responds positively to cold test
* Clinical symptoms of irreversible pulpits
* Tooth is restorable and can be restored with coronal restoration
* Bleeding normally is confirmed after pulp exposure
* hemostasis could be achieved within 8 minutes

Exclusion Criteria:

* Non restorable teeth
* necrotic teeth
* hemostasis could not be achieved within 8 minutes
Tooth Roots for Lateral Alveolar Ridge Augmentation

A deficient alveolar ridge segment in prepara¬tion for implant placement can be regenerated by several techniques. The type of graft material for each patient depends on many factors such as the anatomy, the morphology of the bone defect, type of prosthodontic rehabilitation and patient or clinician preferences. Bone graft material should have three properties that made it ideal: a) osteoconduction, it provides scaffolds for bone regeneration; b) osteoinduction, it promotes the recruitment of bone-forming cells and formation of bone and c) osteogenesis, induction of cells in the graft to promote regeneration of the bone.

Despite of the development of different types of graft material, autogenous bone is still the gold standard for bone augmentation because it exhibits these three mentioned properties. Although it has many advantages, autologous bone has some disadvantages such as high resorption rate up to 50 %, limited source and donor site morbidity. Allografts, xenografts and alloplastic bone graft are materials that are used in everyday practice and over long period, but their disadvantages are numerous in comparison with autologous bone. Allografts can be carrier of some disease and show lack of osteoproliferation, while alloplasts and xenografts show only osteoconduction. According to these facts, it is obvious that there is a need for development an alternative graft material that will surpass these disadvantages.The reconstruction of deficient alveolar ridge defect by the lateral bone augmentation prior to the dental implant placement is predictable and commonly used method. Except animal studies, recent clinical studies showed that there is no difference in the osseointegration of titanium implants in deficient alveolar ridges reconstructed with autogenous cortical bone blocks or autogenous teeth.


Eligibility Criteria:
Inclusion Criteria:

* age 18 to 60 years
* candidate for lateral ridge augmentation
* insufficient bone ridge width at the recipient site for implant placement
* sufficient bone height at the recipient site for implant placement and (e)
* healthy oral mucosa
* at least 2 mm keratinized tissue

Exclusion Criteria:

* general contraindications for dental and/or surgical treatments
* inflammatory and autoimmune disease of the oral cavity,
* uncontrolled diabetes (HbA1c \> 7%)
* history of chemotherapy or radiotherapy within the past five years,
* previous immunosuppressant, bisphosphonate or high- dose corticosteroid therapy
* smokers
* pregnant or lactating women
Clinical Utility of the Addition of a SNP-based NIPT Zygosity Determination in Twin Pregnancy Management.

The ZTWINS registry study is an observational, prospective, multi-center study observing women carrying a twin pregnancy who receive snp-based non-invasive prenatal screening and zygosity assessment as part of their medical care.

This observational data collection study will include subjects with ultrasound-confirmed twin pregnancy and planned NIPS zygosity assessment as a part of their clinical care. Initial chorionicity assessment and, when available, planned twin pregnancy management (e.g., frequency of prenatal ultrasounds, maternal fetal medicine (MFM) referral etc) will be recorded in the study database. Following zygosity results being returned through clinical care NIPS, updated chorionicity \& amnionicity will again be recorded in the study database. Other clinical data in the medical record as part of clinical care, including monochorionic twin pregnancy complications (TTTS, FTC referral, etc), placenta pathology findings, and delivery and neonatal outcomes will also be recorded in the study database. There will be no study blood sample collection or other study procedures performed as part of this study.

Eligibility Criteria:
Inclusion Criteria:

* Women with an ultrasound confirmation of twin pregnancy

Exclusion Criteria:

* Singleton or non-twin multiple pregnancy
The Alzheimer's Companion Engagement (ACE) Project.

Black family caregivers of older adults with Alzheimer's disease and/or related dementias (ADRD), have an increased mortality risk related to pre-existing health conditions and stress. Targeted, culturally responsive, health interventions that help Black ADRD caregivers to effectively manage their own health and use community preferenced ways of coping, can improve caregivers' overall health, perceived ability to provide care for a person with ADRD (self-efficacy), and increases the likelihood that they will experience benefits from caregiving. This clinical trial pilot will test the feasibility of a community based intervention designed to improve health outcomes for Black family caregivers of persons with ADRD.

The proposed intervention is a peer-supportive and facilitator-led video teleconference program that will engage small groups of caregivers weekly over 6 weeks. Each week participants (n = 36, 2-5/group) will receive a different culturally relevant caregiving or personal health strategy to practice. During the support calls, a facilitator will provide an overview of the content covered and each participant will have the opportunity to discuss their past week and how they engaged the weekly strategy, or challenges that came up for them during the week. The format will be structured to ensure that core content is reviewed, and everyone can be equally engaged while flexible enough that caregivers can receive support in the areas they need. A battery of assessment measures will be taken at weeks 1 and 8.

Eligibility Criteria:
Inclusion criteria for participation are as follows:

Self-identified as Black/ African American At least 18 years old Able to speak, understand, and hear spoken English Related to, or has a close personal relationship to a person over the age of 55 that has an ADRD diagnosis or evidence of cognitive impairment Regular access to a smartphone, tablet or computer with internet access that will allow video conferencing engagement.

Provides monitoring, and assistance in activities of daily living and or other care tasks for the care recipient.

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Serum Ferritin as a Non-invasive Marker in Prediction of Hepatic Fibrosis Among NAFLD Patients

This study was designed to assess the relation between serum ferritin and hepatic fibrosis in patients with NAFLD. It included 83 patients with NAFLD with or without hepatic fibrosis, in addition to 30 healthy subjects included as controls. Measurement of serum ferritin and its correlation with steatosis and fibrosis was done.

Background: many studies have found a relationship between hepatic iron, serum ferritin and NAFLD or its progress. Aim of the work: is to assess the value of serum ferritin as a non-invasive marker in prediction of hepatic fibrosis in NAFLD. Methods: This study included 113 subjects who were classified into 3 groups. Group I: included 30 healthy subjects as control with no evidence of NAFLD by liver biopsy. Group II: included 31 NAFLD patients without fibrosis proved by liver biopsy. Group III: included 52 patients with hepatic fibrosis on top of NAFLD proved by liver biopsy. Serum ferritin was determined using Ferritin ELISA kit. FIB4 was calculated and liver biopsy was done for all patients.

Eligibility Criteria:
Inclusion Criteria:

* adult patients with NAFLD with or without hepatic fibrosis

Exclusion Criteria:

* Significant alcohol consumption, other causes of liver disease such as viral hepatitis, schistosomiasis, autoimmune, hereditary, drug induced, or decompensated liver cirrhosis.
A 3-Part Study to Evaluate the Safety, Tolerability, PK, and Food Effect of BMB-101 in Healthy Volunteers

This study is designed as a single centre, double blind, placebo controlled, randomized, SAD/FE/MAD, safety, tolerance and PK study of BMB-101 in healthy adult subjects. The study will be conducted as a 3-part study.

This study is designed as a 3-part study:

Part 1 is designed as single ascending dose (SAD) escalation study investigating 4 dose levels. Each cohort will consist of participants to be randomly assigned to receive a blinded oral dose of BMB-101 or placebo.

Part 2 is designed as a randomized, orally administered, single-dose, two-treatment (fed vs fasted), two-period, two-sequence crossover to assess the effects of a standard high-fat breakfast on PK of BMB-101.

Part 3 is designed as a multiple ascending dose (MAD) escalation study investigating up to 4 dose levels. Subjects will be randomized to receive double-blind treatment of BMB-101 or matching placebo twice daily for 7 days.

Eligibility Criteria:
Key Inclusion Criteria:

1. Subject must be aged between 18 and 55 years (both inclusive).
2. Healthy subjects with no clinically significant screening results.
3. Body mass index (BMI) 18.0 to 32.0 kg/m².
4. Males and non pregnant females willing to use contraceptives consistent with local regulations from screening through 3 months after the last dose of study medication.
5. Agree to frequent blood and urine sampling during the course of the study.
6. Agree to be confined in the study unit and follow study procedures.

Key Exclusion Criteria:

1. Subjects with unstable or severe illness as indicated on medical history, physical examination, or clinical laboratory, vital signs, and electrocardiograms (ECGs) evaluations, or in the opinion of the Investigator.
2. Subjects with reported history within past 6 months of, or current treatment for, any GI disease that may impact the absorption of an oral drug for example gastroesophageal reflux disorder, peptic ulcer disease, inflammatory bowel disease.
3. Subjects with a history of seizures other than febrile seizures as a child.
4. Subjects with history of or current glucose intolerance; or with history of gestational diabetes.
5. Subjects with lifetime history of suicidal behavior or with lifetime history of suicidal ideation as indicated by the Columbia-Suicide Severity Rating Scale (C-SSRS)
6. Subjects with any use of or intent to use any medications, including prescription, over-the-counter (OTC), herbal preparations, or vitamin/mineral supplementation, other than study medications, from 7 days prior to first dose through follow-up visit.
7. Female subjects with a positive pregnancy test at Screening or Day -1 or who are breastfeeding.
8. Subjects who have used more than 5 cigarettes, cigars, or nicotine-containing products per month within 6 months prior to first study dose, or plan to use them through completion of the follow-up visit.
9. Subjects with a positive drug screen for illegal drugs including cannabis at Screening or Day -1.
Inflammatory and Fibrotic Markers and Atrial Fibrillation

Inflammatory and Fibrotic protein markers in patients with atrial fibrillation


Eligibility Criteria:
Inclusion Criteria:

* Patients with atrial fibrillation

Exclusion Criteria:

* Patients with atrial fibrillation who are reluctant for the study
Registry of Patients With Acute Dyspnea in the Emergency Department

This is a prospective registry of patients presenting with acute dyspnea to the emergency department of the city hospital in Nuremberg. There is evidence that acute dyspnea is associated with a mortality rate of 10%, however acute dyspnea is not perceived as a life-threatening condition, both in public and in health care providers. Our aim is to describe the patient collective concerning their demographics, baseline characteristics, type of referral and disposition, medical care processes and prognosis. Secondly, we want to evaluate if the subjective risk assessment of emergency department personnel matches with objective risk stratification tools and the actual outcome of the studied patients.

This is a prospective registry of patients presenting with acute dyspnea to the emergency department of the city hospital in Nuremberg during May 23th 2013 and October 31th 2013. To be included into the registry the patient has to express acute dyspnea. Minor patients are not included. The admission documents of the studied patients are accompanied by a questionnaire that has to be completed by the triage nurse and the attending physician. The questionnaire includes items like professional experience and subjective assessment of patient's prognosis. In addition the attending physician has to state if the evaluation of medical history was difficult, if previous medication is known and how likely the presence of heart failure as underlying condition is. Data of the questionnaire, the patient record and the follow up contacts are entered in a SPSS database. Finally, we measure the OPTIMIZE-HF score (Abraham et al. 2008) and the PRIDE mortality score (Baggish et al. 2007) in a retrospective manner in order to compare the subjective assessments with objective criteria.

Eligibility Criteria:
Inclusion Criteria:

* expression of acute dyspnea in the emergency department

Exclusion Criteria:

* age \< 18 years
Color Stability of Two Different Resin Matrix Ceramics

This is in vivo study aimed to evaluate the color stability of the newly introduced resin ceramic matrix (cerasmart )\& (vita-enamic ) after a one year

This is in vivo randomized clinical trial aimed to evaluate the color stability and patient satisfaction of the newly introduced resin ceramic matrix (cerasmart )\& (vita-enamic ) in posterior endodontically treated teeth through one year follow-up

Eligibility Criteria:
Inclusion Criteria:

* diagnose need for restoration in endo treated posterior teeth
* good general health and oral health
* occlusal stability

Exclusion Criteria:

* smoking
* pregnancy
* use drugs that affect oral health
* Para functional habits