cyrilzakka/clinical-trials huggingface dataset:
Soft Tissue Integration of Different Abutment Surfaces

Objective of the present study was to assess the peri-implant soft tissue profiles between argon plasma pre-treated (PT) and non-treated (NPT) abutments by comparing clinical and histological parameters 2 months after abutment placement.

Patients that need implant supported restoration were recruited for this study. At baseline a specific abutment was screwed at 20 N.Two months following healing abutment placement clinical measurements were evaluated.

Endopoints of the study:

Histological outcomes at 2 using traditional histological staining (ematossilin/eosin) Immunohistological outcomes at 2 using different stainings. Postoperative complications. Comparison between the histological outcomes and the preoperative clinical evaluation of the sites

Eligibility Criteria:
Inclusion Criteria:

1. Patient requiring implant supported restoration.
2. Residual alveolar bone width of edentulous jaw of \> 8mm.
3. Keratinized mucosa width of \>6mm
4. Males and females between 18-80 years old
5. Patients with healthy periodontal conditions (Treated periodontitis, PI\<25%, BoP\<25%)
6. Patients that are willing to sign an informed consent and participate in a clinical study
7. Generally fit and healthy and able to undergo oral surgical procedures under local anesthesia.
8. Teeth at the surgical site which required removal were extracted a minimum of 12 weeks prior to sinus floor elevation

Exclusion Criteria:

1. Patients who smoke over 10 cigarettes/day
2. Pregnancy (confirmed by verbal inquiry)
3. Chronic systemic pathologies (e.g. diabetes) and neoplastic of the Oro-Facial District 4.
4. Patients taking bisphosphonates
5. Any sites where an implant already failed sites
6. Untreated Periodontitis
7. Dental sites with acute infections
8. Chronic inflammatory diseases of the oral cavity
9. Autoimmune diseases (cortisone intake)
10. Allergy declared to one or more medicaments to be used during treatment
11. Alcoholics patients and/or drug addicts.
12. History or malignant tumours of the maxillary sinus
13. History of local radiation therapy
Child With Anomalous Drainage of IVC to Left Atrium

The purpose is to see if any conclusions can be drawn about the uncommon heart defect: anomalous drainage of the inferior vena cava to the left atrium.

Dr. Kogon would like to do a case-report and review of the literature regarding children with the diagnosis of anomalous drainage of the inferior vena cava to the left atrium. At Children's Healthcare of Atlanta, we have seen a single patient with this diagnosis in 2004 and Dr. Kogon would like to discuss this patient in combination with the others already in the literature to see if any conclusions can be drawn about this uncommon heart defect. Currently there are about 20 cases reported in the literature and Dr. Kogon will be reporting on this one case seen in 2004.

The case report of our patient will utilize his medical chart. We hope to provide a brief summary of his clinical presentation, his radiographic evaluation, his operative findings, and his outcome. The only PHI that will be collected will be dates (i.e. date of birth, dates of procedures).

Eligibility Criteria:
Inclusion Criteria:

* single case
* child with anomalous drainage of the inferior vena cava to the left atrium
* at Children's Healthcare of Atlanta

Exclusion Criteria:

-
Improving Neuroprotective Strategy for Ischemic Stroke After Thrombectomy Followed by DELP (INSIST-DELP)

Delipid Extracorporeal Lipoprotein filter from Plasma (DELP) has been found to improve neurological function and life ability of AIS patients and approved for the treatment of AIS by China Food and Drug Administration (CFDA). Our recent study imply that the neuroprotective effect of DELP involved multiple neuroprotective mechanism such as anti-inflammation, free radical scavenging, and decreasing MMP-9. Based on the multiple mechanisms, DELP was used to investigate the effect on acute ischemic stroke receiving endovascular treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years;
* acute anterior circulatory cerebral infarction with large vessel occlusion;
* NIHSS≥6 before endovascular treatment;
* good recanalization (TICI 2b-3);
* time from onset to groin puncture is less than 8 hours;
* time from recanalization to DELP is less than 2 hours;
* Premorbid mRS 0 or 1;
* Signed informed consent.

Exclusion Criteria:

* poor recanalization (TICI 1-2a);
* Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia （ \<100000/mm3;
* Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
* Severe hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);
* Previous allergy to heparin or calcium;
* hypoproteinemia;
* Unsuitable for this clinical studies assessed by researcher.
A Clinical Trial to Examine the Efficacy of a Supplement to Support Hormone Regulation in Women

This randomized, triple-blind, placebo-controlled trial will evaluate the efficacy of Live Conscious's Beyond Hormone supplement in regulating hormone production in women. The study involves 50 generally healthy female participants aged 25-45 who are not menopausal. The trial spans three menstrual cycles and assesses both objective hormone levels and subjective well-being through blood tests and questionnaires, respectively.


Eligibility Criteria:
Inclusion Criteria:

* Female at-birth, aged 25-45.
* Not menopausal or perimenopausal.
* Regularly menstruating.
* Not taking any medication, supplement, or vitamin affecting hormone levels.
* Generally healthy and not living with any uncontrolled chronic disease.

Exclusion Criteria:

* Medical conditions or treatments affecting hormonal regulation.
* Endocrine disorders, gynecological or reproductive health conditions.
* Use of hormonal contraceptives or hormone therapy.
* Recent major illness or surgery.
* Severe allergies or hypersensitivities.
Evaluation of Wound Biofilm in Acute and Chronic Wounds

Patients who present to a wound care center for management of their wounds will be evaluated clinically to establish if their wounds are chronic or acute. These patients will undergo standard of care management of their wounds. If debridement is indicated for the patient, the patient will be asked to participate in a study. Once the standard of care debridement is complete, the material debrided from the wound, instead of being discarded into a biohazard bag, will be prepared for shipment. The samples will then be shipped to the Center for Biofilm Engineering where microscopic evaluation will be conducted on the material. Conclusion will be made from that analysis.

A planktonic concept of the bacteria present on the surface of a chronic wound is no longer viable. Microscopic studies show that biofilm is present on chronic wounds yet does not seem to be prominent on the surface of acute wounds. Biofilm is able to neutralize our host defenses and commandeer host systems, and possesses an impressive array of defenses and virulence factors. Clinically we see a significant difference in the healing behavior between chronic and acute wounds. Also, suppression of biofilm using multiple simultaneous strategies including debridement, anti-biofilm agents, specific biocides, antibiotics and advanced technologies improves wound healing. This suggests biofilm plays an important role in delayed wound healing.

Eligibility Criteria:
Measurements of Displacement Amplitude and Angular Velocities During Passive Extension of the Wrist and Hand Complex in Stroke Patients

The main objective of this monocentric prospective study is to evaluate the amplitudes and angular velocities of extension of the hand and wrist joints during passive mobilization by a physiotherapist in healthy subjects and stroke patients with spastic hands.

Secondary objectives:

* To compare amplitude and angular velocity values between the group of stroke patients and the group of healthy volunteers,
* To compare amplitude and angular velocity values according to the two types of mobilization (i,e, thumb or fifth finger),
* To assess pain due to mobilization in stroke patients.

Conduct of research:

The realization of the measures will take place at the GHRMSA rehabilitation department.

After receiving the written consent of the study participant, the physiotherapist will proceed with the passive mobilization of the spastic hand of the stroke patient or the dominant hand for healthy volunteers. Videos of the hand will be made using the Darfish system which will allow analysis of the primary endpoint.

Two mobilizations will be performed for each participant, i.e. one for each type of medial or lateral grip. The order of mobilization will be determined by randomization.

Eligibility Criteria:
Eligibility criteria of stroke patients with hand spasticity:

Inclusion Criteria:

* Age ≥ 18 years old
* First stroke diagnosed less than 3 months ago
* Non-functional wrist defined by the Fugl-Meyer Assesment (FMA-EU) upper limb motor subscale with a score ≤45
* Wrist flexor spasticity defined by the Modified Tardieu Scale (MTS) with a rating ≥1
* Written informed consent

Exclusion Criteria:

- None

Eligibility criteria of healthy volunteers:

Inclusion criteria:

* Age ≥ 18 years old
* Written informed consent

Exclusion Criteria:

- None
Positive Airway Pressure Treatment of Obstructive Sleep-disordered Breathing in Hypertensive Disorders of Pregnancy

The purpose of this study is to conduct a pilot randomized, controlled trial to evaluate the feasibility and obtain pilot outcome data for a subsequent definitive trial evaluating the effects of postitive airway pressure (PAP) treatment of obstructive sleep-disordered breathing (OSDB) on blood pressure control and maternal and fetal outcomes in hypertensive disorders of pregnancy. The primary aim of the pilot study is to assess feasibility measured as the rates of subject recruitment, adequate (\>4h/night) PAP adherence (primary outcome measure) and protocol completion. Secondary aims will be to obtain preliminary data on the effects of PAP on maternal blood pressure, complications of hypertension, arterial stiffness and vascular biomarkers, course of labor and delivery and fetal outcomes including growth restriction, prematurity, and neonatal distress.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 y with a singleton pregnancy, ≥ 12 weeks' gestation
* diagnosis of hypertensive disorder of pregnancy, including pre-existing hypertension, gestational hypertension and pre-eclampsia, as defined by Canadian Hypertensive Disorders of Pregnancy Working Group Criteria (Magee et al; Best Practice and Research Clinical obstetrics \& Gynaecology. 2015;29(5):643-657)
* presence of obstructive sleep-disordered breathing (OSDB) on a single night in-home complete (Level 2) polysomnogram defined by an apnea-hypopnea index (AHI) ≥ 5 events/h and/or the presence of inspiratory flow limitation on ≥ 30% of breaths.

Exclusion Criteria:

* severe pre-eclampsia/eclampsia requiring urgent delivery
* chronic kidney disease or other secondary cause of hypertension
* known cardiac disease, transient ischemic attack/stroke
* malignancy or other chronic medical or psychiatric condition
* smoking, alcohol use, illicit drugs
* current/recent treatment for sleep-disordered breathing
* severe sleep-disordered breathing defined as an apnea-hypopnea index (AHI) ≥ 30/h with either severe sleepiness (Epworth sleepiness score ≥ 15) or hypoxemia (4% Oxygen Desaturation Index ≥30/h or arterial oxygen saturation (SpO2) \<80% for \>10% of Total Sleep Time)
Fluid Management Guided by Bioimpedance Analysis in Peritoneal Dialysis(PD) Patients.

1. Purpose: to investigate the effect of bioimpedance analysis(BIA) guided fluid management versus experiential way on clinical outcome in peritoneal dialysis patients.
2. Design: prospective,randomized,controlled,single center study
3. Study hypothesis: Patients on peritoneal dialysis are frequently hypervolemic, which is associated with increasing hazard of death and cardiovascular events. Bioimpedance analysis is a safe, and easy way, which appears to be more useful and sensitive than other techniques for assessing volume status in dialysis patients. Therefore we hypothesize that more concise and strict fluid management guided by BIA may help to improve patients' survival, decrease cardiovascular events and hospitalization rate.
4. Objects: incident and prevalent patients with overhydration status.

   1. anticipated cases:240
   2. arms: all the patients are randomized into two arms.(BIA group/clinical group)
   3. observational time:12 months
5. Primary Outcome: all cause mortality. Secondary Outcomes: technique survival, cardiovascular events, peritonitis, residual renal function.


Eligibility Criteria:
Inclusion Criteria:

* patients who are undergoing peritoneal dialysis and clinically stable for at least 3 months;
* 18 Years and older;
* ratio extracellular water (ECW)/total body water(TBW)≧0.4;
* signed the informed consent

Exclusion Criteria:

* patients who have mental graft;
* amputation;
* patients who is unable to accomplish the BIA measurement in standing position for 3 minutes;
* patients whose heart function are class IV estimated by New York Heart Association (NYHA) standard;
* Patients who have acute complications within 30 days prior to study enrollment;
* patients whose life expectancy is within 6 months;
* patients who are pregnant;
* patients who are unable to give consent.
High-field Brain Magnetic Resonance Spectroscopy

Magnetic resonance spectroscopy (MRS) allows non-invasive measurement of the concentration of up to 18 metabolites in the brain ("neurochemical profile").

The objective of this proposal is to develop new methods for high-field brain MRS (3 to 7 Tesla).

Our main hypothesis is that higher magnetic fields lead to improved spatial and temporal resolution and improved quantification precision.

Aims

1. To obtain improved "neurochemical profiles" in the brain using single voxel proton MRS at very high field (3 Tesla to 7 Tesla).
2. To develop new methods for proton magnetic resonance spectroscopic imaging (MRSI) to obtain metabolic maps at very high field (3 Tesla to 7 Tesla).

Since this project is focused on technical development, only healthy volunteers will be recruited (no patients).


Eligibility Criteria:
Inclusion Criteria:

* over 18 years old

Exclusion Criteria:

* no metallic implant or other MRI-incompatible device
Implementing OSCE in Team Based Learning Format for Teaching Clinical Skills to Undergraduate Medical Students

The goal of this clinical trial is to evaluate the effectiveness of using OSCE(objective structured clinical exam) on principles of TBL (team based learning) in teaching clinical skills to undergraduate medical students. The main question it aims to answer is whether using OSCE on TBL format is an effective role for teaching clinical skills in undergraduate medical students.

4th year MBBS students included in study after informed written consent. By simple random sampling students divided into two groups i.e. Experimental and control group.

Control group was named Group A while the interventional group was Group B. Control group (Group A) underwent traditional teaching of skills as routinely carried out in gynecology department during clinical clerkship of three weeks. Group B underwent intervention in the form of learning session where OSCE was implemented on principles of Team-based learning. Both groups had pre-test at start of study in the form of two OSCE stations with pre-validated checklists, to check their baseline knowledge. Post-test on same stations was taken after traditional teaching for group A and intervention for group B. The groups were later crossed over so no student was devoid of the learning experience.


Eligibility Criteria:
Inclusion Criteria:

* Willing students of 4th year MBBS HITEC-IMS Taxila who passed their professional exam

Exclusion Criteria:

* • Dropouts and students not willing to participate

  * Students who failed in professional exam and have to appear in supplementary exam.
Baricitinib Plus Glucocorticoid for Eosinophilia in IgG4-RD

Evaluation of efficacy and safety of Baricitinib combined with glucocorticoid in patients of IgG4-related disease with eosinophilia.

This is a multicenter, 52-week prospective, randomized controlled study to compare the efficacy and safety of Baricitinib combined with glucocorticoid and glucocorticoid monotherapy in proliferative IgG4-RD patients with eosinophilia.

Eligibility Criteria:
Inclusion Criteria:

1. All patients must meet the following diagnostic criteria of IgG4RD (2020): 1) and radiological features: One or more organs show diffuse or localized swelling or a mass or nodule characteristic of IgG4-RD. In single organ involvement, lymph node swelling is omitted. 2) serological diagnosis: Serum IgG4 levels greater than 135 mg/dl. 3) diagnosis diagnosis: Positivity for two of the following three criteria: a. Dense lymphocyte and plasma cell infiltration with fibrosis. b. Ratio of IgG4-positive plasma cells /IgG-positive cells greater than 40% and the number of IgG4-positive plasma cells greater than 10 per high powered field. c. Typical tissue fibrosis, particularly storiform fibrosis, or obliterative phlebitis.

   Patients fulfill (1) + (2) + (3) are diagnosed as definite IgD4RD; (1) + (2): possible IgG4RD; (1) + (3): probable IgG4RD. exclusion of other diseases.
2. Active IgG4-RD (Responder Index ≥ 2 points for each involved organ)
3. The counts of peripheral blood eosinophil cells ≥0.75×109/L

Exclusion Criteria:

1. Patients who is not able to discontinue GC
2. Pregnancy or breastfeeding or planning to get pregnant within 2 years
3. Received glucocorticoids, immunosuppressants, biological agents or JAK inhibitors within 3 months
4. Allergic to Baricitinib
5. Concomitant other autoimmune diseases
6. Malignancy
7. Chronic HBV infection, latent tuberculosis, or active infection
8. Server liver or renal dysfunction, or heart failure.
Duke COVID-19 Shared Data and Specimen Repository

The purpose of this data repository is to provide a secure and centralized storage location and resource for the collection of essential data and medical specimens, across COVID-19 related protocols at Duke.

The aim of this data repository is to provide a secure and centralized storage location and resource for the collection of core variables of interest, as well as the retaining of relevant patient samples, across COVID-19 related protocols at Duke. The core data variables were in-part selected to specifically match those agreed upon by Academic Medical Centers across the U.S., with the intention of aiding the efficiency and effectiveness of de-identified data reuse for population-level research. An additional benefit is that centralized, shared data storage of demographic and longitudinal variables will reduce subject burden, as many questions will now only need to be asked once, rather than each time a given subject joins another COVID-19 related study at Duke.

This shared data and bio-repository project will house all the core data for all patients with COVID-19 (or suspected cases), as well as individual participants ICFs for all other participating COVID-19 studies enrolling Duke patients. Each participating study will have its own separate IRB approved protocol. Samples may be either collected specifically by the protocol, or include left-over clinical samples from the testing and treatment of patients with COVID-19 at Duke.

Eligibility Criteria:
Subjects will be included in this data repository if they meet the enrollment criteria of any linked/participating IRB-approved protocol, or if they are not enrolled in another COVID-related study but meet one of the following inclusion criteria:

1. Suspected novel Coronavirus (nCoV) infection (Person Under Investigation) and/or
2. Laboratory proven acute novel Coronavirus (nCoV) infection and/or
3. Primary admitting diagnosis of nCoV infection

Studies will include:

* Any COVID-19 clinical research studies recruiting Duke patients
* Excludes: protocols sharing non-consented EHR data with national/international repositories and studies that are recruiting community participants
Clinical Trial Evaluating Efficacy and Safety of One Dose Versus Two Doses of Influenza Vaccination

Randomized, multicenter, open label trial to compare safety and efficacy of two doses stationary flu vaccination vs one doses in Solid Organ Transplant Recipients.

The purposes of this study are:

1. Evaluate the efficacy and safety of a double dose of seasonal flu vaccine compared to a single dose.
2. Determine the specific cellular immune response produced after the first and second vaccine doses of seasonal flu vaccine by in vitro stimulation of specific memory cells (A and B flu viruses).
3. Evaluate the humoral immune response produced after one dose vs two doses of seasonal flu vaccine by the measure of serum antibody levels.
4. Evaluate clinical efficacy of stationary flu vaccine in solid organ transplant recipients.
5. Evaluate a long term cellular and humoral response(1 year) of seasonal flu vaccine.
6. Characterize the genetic expression profile of immune response after the flu vaccine in solid organ transplant recipients by means of a genetic sub-study.
7. Characterize the flu vaccine effect (one dose and two doses) through the antibody anti-HLA(human leukocyte antigen), and its influence on the rejection rate in solid organ transplant recipients, by means of immunologic sub-study.

Eligibility Criteria:
Inclusion Criteria:

1. Solid organ transplant recipient.
2. 16 years or older.
3. More than 30 days after transplantation.
4. Negative pregnancy test for women of childbearing potential
5. The patient must give informed consent

Exclusion Criteria:

1. No written informed consent.
2. Acute rejection within 15 days prior to vaccination.
3. Pregnancy.
4. Hypersensitivity to the active substance, any of the excipients and waste, for example: eggs, egg albumin, chicken proteins.
5. History of a previous serious reaction to immunization (eg Guillain-Barré syndrome).
Body Constitution Classification Based Comprehensive Health Management Intervention on Obese Population

This study aims to explore the effectiveness of body constitution classification based comprehensive health management intervention on obese population.

This study aims to explore the effectiveness of body constitution classification based comprehensive health management intervention on obese population, compare the differences in effectiveness between body constitution classification based management vs usual health management, and explore the influence of different food composition on the effectiveness of body constitution classification based comprehensive health management intervention on obese population.

Eligibility Criteria:
Inclusion Criteria:

* Social characteristics:

  * 20-55 year old,
  * had lived in a city for more than one year,
  * kept a watchful eye on losing weight or bodybuilding,
  * practitioner engaged in non- sensitive sectors.
* Physiological characteristics:

  * met the obesity diagnostic criteria suggested by "Prevention and control Guidelines for overweight and obesity of Chinese adults in 2006". Subjects with a BMI between 24 to 28 kg/m2 were defined as overweight, while those with a BMI greater than 28kg/m2 were obese.
  * met the constitution classification standards of Traditional Chinese Medicine. According to the constitution questionnaire formulated on the base of the Chinese Medical Association standard "Chinese constitution classification and determination" (ZYYXH/T157-2009), the subjects were divided into phlegm-damp type, qi deficiency type and phlegm stasis block type.

Exclusion Criteria:

* with the following major organic disease,
* secondary obesity caused by diseases,
* none of phlegm-damp type, qi deficiency type or phlegm stasis block type,
* women who were planning to become pregnant, pregnant or lactating.