cyrilzakka/clinical-trials huggingface dataset:
The Clinical Therapeutic Effects and Safety of Tissue-engineered Bone

The purpose of this study is to compare use of a tissue-engineered bone to use of a standard allograft bone to treat bone defect in patients. The hypothesis is that use of the tissue-engineered bone is effective and safe to treat the bone defect in patients.

Patients with the bone defect without infection and sever system diseases will be recruited.

The material selected as the scaffold for this study will be a porous β-tricalcium phosphate scaffold (β-TCP) scaffold and scaffold is custom-made according to the size and shape of bone defect after three-dimensional CT scan. Human BMSCs will be obtained and cultured before operation and 3.4×106 cells in 10ml serum-free medium will be seeded onto scaffold to construct the tissue engineered bone graft and co-cultured for two weeks.

The implant operation will be carried out under the general anesthesia. The tissue engineered bone graft will be implanted into the bone defect area. The bone defect area will be covered with surrounding soft tissue and muscle to close the wound. Anti-inflammatory, repercussive and analgesic drugs will be used for 1 week.

Patient will be hospitalized for 1 to 2 weeks after surgery. Blood routine examination, erythrocyte sedimentation rate, immunoglobulin, autoantibodies and clinical examination will be carried out for signs of pain, swelling, immune rejection and infection. Patient will be evaluated at 3 days，3, 6, 12, 18 and 22 months after operation by radiography; Three-dimensional CT scan will be also performed at regular intervals. The function of the body will be evaluated at regular intervals.

Eligibility Criteria:
Inclusion Criteria:

* the patients with bone defect and bone nonunion caused by tumor or trauma
* the length of bone defect in long diaphysis is more than 4cm or more than half of the shaft diameter
* the size of bone defect is more than 5cmx5cm
* the patients are unable to use autologous bone graft or other treatments
* the patients request to use the treatment of tissue-engineered bone
* Supportive family with willingness to participate in completing questionnaires

Exclusion Criteria:

* Patients with serious diseases such as hemorrhagic disorders, infection, tumor, contagion and so on.
* Patients who are pregnant
* Patients with serious abnormal cardiopulmonary function
* Patients disagree to use the tissue-engineered bone
* Patients are older than 60 years
* Patients who are regarded to be unqualified by investigator
Individually Tailored Prophylaxis in Patients With Severe Hemophilia A

Patients with severe haemophilia A lack clotting factor FVIII and suffer from spontaneous and traumatic bleeds. In the absence of treatment, frequent bleeds in joints lead to severe joint destruction. In 1960s, prophylactic therapy was developed involving the infusion of clotting factor on a regular schedule in order to keep clotting levels sufficiently high to prevent spontaneous bleeding episodes. Prophylaxis is started at an early age before the age of 2 years or after the first joint bleed. The Malmö experience indicates that treatment is most effective when administered in large doses at least 3 times weekly. However, such an intensive treatment in young boys may be very difficult to carry out for home treatment. Currently, there is no international recommendation on prophylactic therapy regimens. Because of the high cost and limited availability of factor concentrates, dosing is an important issue in prophylaxis therapy. It was recently shown that 24 hours after FVIII concentrate administration, in patients presenting similar FVIIII levels, thrombin generation capacity may be significantly different. In addition, independently of the FVIII level, a correlation was found between severe clinical bleeding phenotype and thrombin generating capacity. The aim of the present clinical study is to assess the thrombin generation test as the main surrogate marker to evaluate the coagulating capacity of haemophiliacs on prophylaxis regimen. Optimizing prophylactic therapy to patient's phenotype with no loss of clinical effectiveness can significantly improve patients' quality of life, protect haemophilic children against arthropathy and possibly limit the cost of the prophylaxis therapy.


Eligibility Criteria:
Inclusion Criteria:

* Severe haemophilia A (FVIII \< 1 IU/dl)
* Currently on prophylactic therapy administered at least 3 times per week with a clinical efficiency
* Age: 6 - 45 years
* Adequate venous access in adults and children i.e. presence of 2 or more good quality peripheral veins, in order to avoid the need for a central venous device. One peripheral vein for FVIII infusions and one other for blood sampling are required.
* Competent in home treatment and infusion therapy (patient or parents)
* Ability of patient or family (for minors) to give informed consent
* Patient affiliated to French Social Insurance System.

Exclusion Criteria:

* Age \< 6 years and \> 45 years
* Hemophilia A with documented history of inhibitor
* Clinically symptomatic liver disease (supported by e.g. diagnosis of cirrhosis, portal hypertension, ascites, PT \> 5 seconds above upper limit of normal)
* Platelet count \< 100x109/l
* Planned elective surgery within 13 months
* Poor venous access according inclusion criteria
* Presence of a documented target joint
Effects of a Finishing Protocol Implementation in Orthodontic Patients

This study evaluates the effects of a finishing protocol in orthodontic outcomes using ABO-OGS scores. Patients who finish orthodontic treatment and fulfill the inclusion and exclusion criteria receive a treatment using a finishing protocol and their scores are compare with 40 patients who don't receive a finishing protocol

The phase of finishing is the most demanding and detailed of all phases of the orthodontic treatment. American Board of Orthodontics- Objective Grading system is a detailed and objective method that evaluates the quality of the final outcome of orthodontic treatment. In order to evaluate and compare the effects of a protocol implementation on the ABO-OGS scores, standardize cast models and Pan X-Ray from by convenience patients of Orthodontic Postgraduate Program of University of Antioquia who finish orthodontic treatment and receive the protocol are digitized, eight variables are evaluate and ABO-OGS score is calculate. A comparison with 40 no-protocol ABO-OGS scores by convenience-selected patients is done. The protocol includes an educate residents program about finishing problems , an standardized clinical and X-ray assessment , brackets reposition and frequent clinical evaluation. The percentage of the protocol implementation is calculate in every patient and reliability test is make . The descriptive analysis and the ABO-OGS score comparison is done by Pearson or Spearman correlation.

Eligibility Criteria:
Inclusion Criteria:

* Patients who finish orthodontic treatment by orthodontic criteria
* Receive finishing protocol
* Accept and sign inform consent
* Records ( Panoramic Xray and cast models) taken immediately or 7 days after orthodontic appliances are remove

Exclusion Criteria:

* Patients who don't accept being at the study
* Bad quality records
* Prosthodontic, periodontic and surgical needs treatment after orthodontic treatment
Evaluation of the Clinical Effectiveness of Upper Gastrointestinal Endoscopy Reporting System

The objective of this study is to assess the effectiveness of an AI-based reporting system for upper gastrointestinal endoscopy. The primary question that this study aims to address is whether the reporting system can enhance the completeness and accuracy of endoscopic reports when assisted by AI, as drafted by endoscopists. Patients will be randomly assigned to either the experimental group or the control group. In the experimental group, physicians will draft EGD reports with the assistance of the AI-based reporting system, while in the control group, physicians will use the conventional reporting system to draft EGD reports. At the same time, the AI-based reporting system will automatically generate a report of the EGD examination.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years
2. Aim to undergo screening, surveillance, and diagnosis
3. Undergo sedated EGD
4. Able to read, understand, and sign informed consent

Exclusion Criteria:

1. EGD contraindications
2. Not suitable for sedated endoscopy after anaesthesia evaluation
3. Biopsy contraindications
4. Active upper gastrointestinal bleeding or emergency oesophagogastroduodenoscopy (EGD)
5. Pregnancy
6. Upper gastrointestinal surgery or residual stomach
7. Not suitable for recruitment after investigator evaluation because of other high-risk conditions
Emotional Regulation in People With Co-occurring Posttraumatic Stress Disorder and Substance Use Disorder

The aim of this project is to look at emotional regulation in people with posttraumatic stress disorder (PTSD) and substance use disorder (SUD). This study will explore how people with PTSD-SUD regulate their emotions and how this might explain the relationship between these two disorders. In turn, this may inform effective treatment strategies for people with comorbid PTSD-SUD.

Emotional regulation refers to the way in which people process and respond to their emotions. PTSD and SUD commonly cooccur and this is associated with adverse outcomes including high rates of relapse, overdose, and suicide. We therefore need effective treatments to address this clinical concern. Evidence suggests emotional regulation might be important in the development and maintenance of PTSD and SUD and therefore it might be a useful target for treatment. However, most research in this area has been quantitative and has not considered how gender, social circumstances and trauma or substance type might affect the way people regulate their emotions. This study will recruit 40 adults with trauma histories and PTSD who are currently receiving treatment in a community drug and alcohol service for their substance use. Participants will be interviewed to explore how they regulate their emotions and how this relates to their social circumstances. This study will also explore whether gender, substance or trauma type affect the way people regulate their emotions. We hope this will help to improve treatment for people with PTSD and SUD.


Eligibility Criteria:
Inclusion Criteria:

* • Adults aged 18+

  * Receiving treatment from a community substance use service at the time of the study.
  * Experienced, witnessed or been confronted with at least one traumatic event (according to PTSD Diagnostic Scale for DSM-5) (PDS-5) (Foa, 2016).
  * Participant endorses at least 3 PTSD symptoms from criterion B-E, measured using the PDS-5.
  * Able to communicate and understand English sufficiently to engage in a qualitative interview.

Exclusion Criteria:

* • Staff recommend the individual should not take part in the study

  * The individual is unable to provide informed consent
Changes in Plasma Osmolality Related to the Use of Cardiopulmonary Bypass With Hyperosmolar Prime.

During the use of Cardiopulmonary Bypass (CPB) for cardiac surgery there is an instant mixture of the patient's blood and the fluid needed to fill the extracorporeal circuit before use. This will change the composition of the body fluids. This study aims to plot these changes in regard to particle concentration (osmolality).

During the use of CPB for cardiac surgery there is an instant mixture of the patient's blood and the fluid needed to prime the extracorporeal circuit. Many studies have pointed to the benefits of using a hyperosmolar prime to counteract formation of tissue oedema. Rapid changes in osmolality may as a serious consequence lead to osmotic demyelination syndrome. At the Heart Centre of Umeå University Hospital, Sweden, there is a tradition of using a hyperosmolar prime. This study aims to explore changes in osmolality during coronary artery bypass grafting surgery by repeated measurements of osmolality and concentration shifts of sodium, glucose and urea in plasma.

Eligibility Criteria:
Inclusion Criteria:

* Age 60-80 yr
* New York Heart Association Functional Classification(NYHA) I-III
* Body Surface Area(BSA) 1.8-2.5 m2

Exclusion Criteria:

* Diabetes
* Estimated Glomerular Filtration Rate(eGFR)\<50ml/min/1,73 m2
Evaluation of Reliability and Validity of a Smart-phone Postural Control Assessment Application

The purpose of this study is to evaluate the reliability and validity of smart-phone based system in postural control ability assessment on subjects with chronic ankle instability.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of ankle functional instability

Exclusion Criteria:

* any other condition would affect postural control performance
Effects of Gender-affirming Hormone Therapy on Transgender People

This prospective cohort study aims to assess the impact of gender-affirming hormone therapy (GAHT) on transgender individuals' physical, psychological, social, and quality of life aspects. Based on gender minority stress theory, the research recruits 150 individuals each of those starting GAHT and those not yet undergoing it. Data collection involves questionnaires and physiological measurements. Statistical analyses will explore correlations and group differences. Findings can guide transgender individuals considering hormone therapy and enhance care guidelines to improve their overall well-being.

The willingness and proportion of transgender persons diagnosed with gender dysphoria to receive gender-affirming hormone therapy (GAHT) is relatively high, so as to conform to their internal gender identity. However, there are limited studies on the prospectively observation of the influences and effectiveness of GAHT on physical, psychological, social and quality of life of transgender people. This study is a cross-sectional research prospective cohort study design, and the research framework is developed based on gender minority stress theory. It is expected to recruit a group of 150 transgender people, including trans male, trans female, and non-binary person, who have just started using GAHT, and a group of 150 who has not yet received GAHT. The data collection time is about 40-50 minutes each time. The questionnaires will be applied to collect basic demographic information, basic hormonal information, body changes, body image, sexual wellbeing, sexual risk, depression, social support, and quality of life. The instruments will be applied to measure participants' physiological parameters, including weight, body fat, and muscle mass, hand grip strength, and blood pressure. In the statistical part, correlation and regression will be used to analyze the degree of correlation between variables, and multivariate analysis of covariance will be used to detect whether there was a significant difference between the variables of the two groups. A well understanding of the experiences and reactions of transgender people receiving hormone therapy can provide a reference for transgender people before deciding to accept hormone therapy, and can be used as an important reference for formulating care guidelines for gender-affirming hormone therapy to improve the care quality for the gender minority population.

Eligibility Criteria:
Inclusion Criteria:

* transgender

Exclusion Criteria:

-
Rapid Kidney Function Decline in Older Adults

This observational study investigates whether a single set of GFR and urine albumin-to-creatinine ratio (ACR) thresholds can accurately screen for rapid kidney function decline in different elderly groups.


Eligibility Criteria:
Inclusion Criteria:

1. Age greater than 70 years;
2. GFR data measured at least twice (two years apart) and ACR data measured once (at baseline);
3. A clear record of the cause of the previous visit; from this, people diagnosed with kidney disease were selected, and kidney disease was defined as various primary nephritis, secondary nephropathy, acute kidney injury (AKI), chronic kidney disease, kidney tumors, or a diagnosis of proteinuria alone.
4. Signed informed consent form.

Exclusion Criteria:

1. People with missing baseline biochemical data;
2. Outliers in the population indicators, i.e., data deviating from the mean ± three times the standard deviation;
3. Data with significantly abnormal baseline renal function follow-up (abnormally elevated GFR by more than 10% within 2 years or abnormal ACR value as determined by consultation with a senior nephrologist).
Calcitriol, Mitoxantrone, and Prednisone in Treating Patients With Metastatic Prostate Cancer

RATIONALE: Calcitriol may cause prostate cancer cells to look more like normal cells, and to grow and spread more slowly. Drugs used in chemotherapy, such as mitoxantrone and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well giving calcitriol together with mitoxantrone and prednisone works in treating patients with metastatic prostate cancer.

OBJECTIVES:

Primary

* Determine the prostate-specific antigen (PSA) response rate, defined as the fraction of patients with 50% reduction in PSA level over 3 weeks' time, in patients with androgen-independent metastatic prostate cancer treated with high-dose pulse calcitriol, mitoxantrone, and prednisone.

Secondary

* Determine the safety and tolerability of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral high dose pulse calcitriol on day 1, mitoxantrone IV on day 2, and oral prednisone on days 1-21. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed prostate cancer

  * Androgen-independent disease, defined as disease progression while on standard hormonal management, including antiandrogen withdrawal

    * Patients must continue primary hormonal therapy during study treatment
  * Regional or distant metastases
* Prostate-specific antigen \> 5 ng/mL
* No brain metastases

PATIENT CHARACTERISTICS:

Age

* 18 to 100

Performance status

* ECOG 0-3

Life expectancy

* Not specified

Hematopoietic

* Adequate hematologic function

Hepatic

* Adequate hepatic function

Renal

* Adequate renal function
* No calcium-salt kidney stones within the past 5 years
* No hypercalcemia

Cardiovascular

* Adequate cardiac function
* No significant cardiac disease
* No atrial fibrillation

Other

* Fertile patients must use effective barrier contraception during and for 2 months after completion of study treatment
* No other serious medical illness
* No other active malignancy except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

* More than 28 days since prior biologic therapy

Chemotherapy

* No prior chemotherapy

Endocrine therapy

* See Disease Characteristics

Radiotherapy

* No prior strontium chloride Sr 89
* More than 28 days since prior radiotherapy
* More than 56 days since prior samarium Sm 153 lexidronam pentasodium

Surgery

* Prior prostatectomy and/or orchiectomy allowed

Other

* More than 28 days since prior investigational therapy
Rubidium-82 Position Emission Computed Tomography (PET) Versus Gated, Rest / Stress Technetium 99-m SPECT

Many stress tests being done today have two parts, the stress test and the pictures of your heart. The investigators are comparing a newer technique to obtain the pictures (PET imaging) to the standard method (SPECT imaging). However, it is not known if the new test is better than the old test. It is important to have a standard to compare these tests to, and that is why people who will be getting a cardiac catheterization are being asked to participate. The information about your arteries from the cardiac catheterization will be used to judge which stress test is better. The investigators hypothesize that the newer method (PET imaging) will be more accurate than the old method (SPECT) in detecting heart disease.

A SPECT rest image will be obtained using a technetium based isotope. On a separate day, a Rubidium rest PET image will be obtained prior to a Dipyridamole stress test. Subjects will receive both Rubidium and technetium isotopes following the Dipyridamole stress, and will undergo first PET imaging and later SPECT imaging following the stress test. Patients will then go for cardiac catheterization as clinically ordered by their physician.

Eligibility Criteria:
Inclusion Criteria:

* referred for clinical cardiac catheterization

Exclusion Criteria:

* previous CABG
* previous MI
* Asthma or obstructive airway disease
* Intolerance to Dipyridamole
* Moderate to severe valvular disease
* Cardiomyopathy - (ejection fraction less than 45%)
Crestor RUSH (The Efficacy of RosUvaStatin for Korean Dyslipidemia Patients With Hypertension )

To evaluate the efficacy of rosuvastatin in Korean dyslipidemia patients with hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Hyperlipidemia patients who are prescribed with rosuvastatin 10mg, based on clinical grounds and fulfil the following criteria

  1. Over 18 years of age
  2. Currently or previously diagnosed with hypertension and receiving medical care

Exclusion Criteria:

1. Patients already taking other hyperlipidemic agents
2. Patients who do not fulfil the indication criteria for statin therapy
3. Patients who do not have baseline and/or follow-up lipid data to verify the efficacy data
Caries Sealing Using Giomer and Glass Ionomer Cement With or Without Silver Diamine Fluoride

The purpose of this study is to evaluate and compare the clinical performance of Giomer and GIC restorations with and without SDF on caries sealing of primary molar teeth

Restorations will be placed on four primary molar teeth with occlusal caries, in a split mouth design. 100 patients will be included in the study. The teeth will be randomized into four groups according to the restorative materials.

Group 1: SDF (Riva Star) + Giomer (Beautifil II, (Shofu Dental, Tokyo, Japan) Group 2: Giomer (Beautifil II, (Shofu Dental, Tokyo, Japan) Group 3: SDF (Riva Star) + GIC (Equia Forte, GC, Japan) Group 4: GIC (Equia Forte, GC, Japan)

The restorations will be evaluated clinically at baseline and 6., 12., 18., 24. months and radiologically at 6., 12. and 24. months. The modified US Public Health Service criteria (secondary caries, marginal integrity, marginal discoloration and retention) will be used for clinical evaluation of restorations. Intra-oral photos will be taken directly after treatment and at control appointments.

The data will be analysed statistically using Wilcoxon test, chi square test and the Kaplan-Meier survival method will be used to estimate survival percentages.

Eligibility Criteria:
Inclusion Criteria:

* Patients and parents of the patients who accept to participate and sign the informed consent.
* Patients who have at least four first and/or second primary molars that require class I restorations
* Teeth that have healthy lamina dura and periodontal ligament
* Teeth that have caries lesions not extending to the pulp radiographically
* Patients whose first molar teeth are in occlusion

Exclusion Criteria:

* Patients and parents of the patients who does not accept to participate and sign the informed consent
* Teeth which need endodontic treatment
* Teeth that have caries more than one surface
* Teeth that are previously restored
* Patients who are not cooperative for the dental procedure
* Teeth that doesn't have proximal or occlusal contacts with adjacent healthy teeth
* Patients who have bruxism, skeletal or dental malocclusion
* Teeth that have developmental defects/anomalies or discoloration
* Patients who have allergies to resin based restorative materials