cyrilzakka/clinical-trials huggingface dataset:
Describing Patient With DME, Their Patient Journey and Disease Progression

This study aims to characterize patients with diabetic macular edema (DME), their progression, the treatment received and associate the functional and physiological outcomes related to the treatment.


Eligibility Criteria:
Inclusion Criteria:

All patients ≥18 years, with a DME diagnosis in at least one eye, included in the Vestrum database identified during the study period (January 2015 to April 2023)

Exclusion Criteria:

Patients without the information of laterality will be excluded.
SHAPE AND MOTION - Medical Accompanied Slimming

Background: Overweight and obesity affect health, quality of life and ability to work. Therefore, the scientifically evaluated program "SHAPE AND MOTION - medically ◦ accompanied ◦ slimming" was developed to support overweight and obese people in weight loss.

Method: In a randomized controlled clinical trial, the effect of a lifestyle intervention with meal replacement by formula diet, exercise stimulation, and telemedicine coaching is examined compared to a control group with routine care. The learning contents are taught in 7 group trainings, a practical unit with shopping and cooking training, as well as in 4 individual telephone conversations. The state of health is examined at the beginning, after 12 and 26 weeks.

Objective: The aim is to develop a training and counseling program for overweight or obese individuals with diabetes risk or type 2 diabetes, which can be used both for primary and for tertiary prevention of overweight-related diseases.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index ≥ 25 kg/m2

Exclusion Criteria:

* acute diseases such as respiratory or gastrointestinal infections
* severe diseases such as tumors, chronic obstructive pulmonary disease (COPD), asthma, dementia, chronic bowel disease, psychosis, liver cirrhosis, (macro) nephropathy, renal insufficiency with glomerular filtration rate (GFR) \<30
* ongoing chemotherapy, chron. Cortisone treatment
PASS Study To Evaluate The Potential Of Zithromax To Cause Ocular Problems In Pediatric Patients

This Post-Authorization Safety Study (PASS) is intended to fulfill a regulatory post-marketing requirement to provide data regarding visual abilities in children taking azithromycin (immediate-release formulation) for acute pharyngitis/tonsillitis. The primary objective of the study is to examine the incidence of clinically significant worsening in any of the following ophthalmic exams: best corrected visual acuity (distance), color vision, Amsler grid testing, anterior segment biomicroscopy, and fundus examination, in a group of approximately 30 pediatric patients taking azithromycin oral solution for treatment of an authorized indication of use (pharyngitis/ tonsillitis).

Study was terminated prematurely on October 16, 2015 following FDA decision to release Sponsor from post-marketing commitment. No safety and/or efficacy concerns identified.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patient, aged 12 to 17 years.
* Requires outpatient treatment for acute pharyngitis/tonsillitis infection.
* Appropriate to treat with oral azithromycin as an alternative to intramuscular penicillin, in the opinion of the investigator.
* Positive rapid antigen detection test.

Exclusion Criteria:

* History of clinically significant eye disorder that would interfere with protocol test procedures.
* Hypersensitivity to azithromycin, erythromycin, any macrolide, or ketolide antibiotic.
* Increased risk of QT prolongation.
* Pregnant or breastfeeding.
Surgery for Primary Hyperparathyroidism (pHPT) in Patients Older Than 65 Years Compared With Follow-up

General consensus and contemporary guidelines, recommend surgery for primary hyperparathyroidism (pHPT)for all patients below the age of 50, for patients with pronounced hypercalcemia and for patients with organ complications to the disease (osteoporosis and decreased renal function).

The purpose of this study is to determine if surgery for pHPT, is appropriate for patients with moderate to mild hypercalcemia older than 65 years of age.

The hypothesis of the study is that surgery for pHPT in patients older than 65 years of age, and with mild hypercalcemia, will increase bone density and hence decrease future risk for fragility fractures compared to patients with follow-up only.

The majority of patients diagnosed and operated due to primary HPT in Scandinavia are older than 65 years of age. The vast majority of the patients have mild aberrations of serum calcium (\< 1.50 mmol/l ionized calcium), and some patients may even be asymptomatic. The present trial is designed to clarify the indications for surgical treatment in this large subgroup of patients.

Eligibility Criteria:
Inclusion Criteria:

* Primary Hyperparathyroidism
* No previous parathyroid surgery
* Sporadic disease

Exclusion Criteria:

* Z-score of Bone density \< -2.5 SD (regardless of site)
* Serum level of ionized calcium \> 1.50 mmol/L
* Inability to understand given information or to comply with scheduled follow-up
* Symptoms of hypercalcaemia for which specific medical treatment has been prescribed
A Single-center Clinical Trial of Bortezomib in Management of Immune Thrombocytopenia (ITP)

Primary immune thrombocytopenia (ITP) is a disorder caused by autoantibody-mediated platelet destruction and decreased platelet production. It has been reported that refractory ITP is closely related to long-lived plasma cells (PCs), which are resistant to glucocorticoids, conventional immunosuppressive and cytotoxic drugs, irradiation and B-cell depletion therapies.

Proteasome inhibition bortezomib is one of the most promising therapeutic approaches to target PCs, since this strategy has been shown to efficiently eliminate multiple myeloma cells, that is, transformed PCs. It also has been successfully used in SLE-like mice, experimental autoimmune MG rats and experimental hemophilia-A mice that develop anti-factor VIII antibodies in preclinical models by depleting both short-lived and long-lived PCs. Additionally, treatment with bortezomib resulted in a rapid clinical response in a patient with refractory thrombotic thrombocytopenic purpura associated with the depletion of inhibitory autoantibodies against ADAMTS13, a metalloproteinase that cleaves the von Wille-brand factor, which is produced by plasma cells. Hence, the elimination of autoreactive PCs by proteasome inhibitors might represent a new treatment strategy for autoantibody-mediated diseases.

To date, refractory ITP is lacking of effective treatments and these findings encouraged us to conduct a study of bortezomib in management of ITP with high anti-platelet antibodies level. Data from this study may provide some idea of bortezomib in the treatment of ITP.

The investigators are undertaking a single-center, single-arm study of 20 primary ITP adult patients from Shandong University Qilu Hospital

. All the participants are selected to receive bortezomib treatment (given intravenously at a dose of 1.3mg/m2 on days 1,4,8,11). Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* failure to achieve at least Response
* need of treatment(s) (including, but not limited to, low dose of corticosteroids) to minimize the risk of clinically significant bleeding. Need of on-demand or adjunctive therapy alone does not qualify the patient as refractory
* primary ITP confirmed by excluding other supervened causes of thrombocytopenia

Exclusion Criteria:

* pregnancy
* hypertension
* cardiovascular disease
* diabetes
* liver and kidney function impairment
* HCV, HIV, HBsAg seropositive status
* patients with systemic lupus erythematosus and/or antiphospholipid syndrome
Supplemental Thyroxine Treatment for Preterm Infants With Hypothyroxinemia

In order to determine the efficacy and safety of thyroxine replacement, a randomized clinical trial of thyroxine supplementation for VLBW infant with hypothyroxinemia during the first month of age is conducted.

A prospective randomized unmasked controlled trial is conducted. Newborn infants with birth weight less than 1500g are randomized into thyroxine treatment or un-treatment group.

Eligibility Criteria:
Inclusion Criteria:

* Birth weight: less than 1500g
* Gestation: 22 weeks 0 day ≤
* Serum free thyroxine level lower than 0.8 ng/dl
* Serum thyrotropin lower than 10 μU/ml
* Age of between 2 and 4 weeks after birth
* Informed consent

Exclusion Criteria:

* any known thyroid disease in mother
Persistent Pulmonary Hypertension of the Newborn (PPHN) Observational Study

This study was an observational study to estimate the prevalence of Persistent pulmonary hypertension of the newborn (PPHN) among term or near-term infants with severe respiratory disease.

The optimal approach to the treatment of PPHN remains controversial. In 1978, hyperventilation was advocated for the treatment of PPHN. Newer therapies such as alkali infusion have been introduced without the support of randomized trial. In addition, in 1993, large controlled trials of inhaled nitric oxide were in the planning stages. There is a lack of knowledge about how these diverse management styles impact patient outcome.

Given the large number of treatments used in neonates with PPHN, we wished to document treatment of PPHN and outcomes of those treatments. Therefore, we performed a prospective, observational study to document prevalence of PPHN, the treatments and outcomes in a large population of infants treated at the 12 centers of the National Institute of Child Health and Human Development (NICHD) Neonatal Research Network. Further, we sought to compare treatment with hyperventilation to treatment with alkali infusion.

Eligibility Criteria:
Inclusion Criteria:

* \>= 34 weeks gestational age
* On mechanical ventilation and/or fraction of inspired oxygen \>0.50; and
* Had documented pulmonary artery hypertension as defined by either two-dimensional echocardiographic evidence of elevated pulmonary pressure (judged by right to left or bidirectional shunt), or a preductal to postductal oxygen gradient \>20 mm Hg

Exclusion Criteria:

* \>7 days of age
Training Executive Functions to Facilitate Recovery Following Traumatic Brain Injury

The purpose of this research study is to investigate different types of task training to determine if training improves thinking processes following traumatic brain injury.


Eligibility Criteria:
Inclusion Criteria:

* If you have had a Traumatic Brain Injury (TBI)or no history of neurological disease/damage.
* If you are between the ages of 19 and 65.

Exclusion Criteria:

For participants with Traumatic Brain Injury:

* If you have a history of prior neurological disorders (e.g., stroke, seizures, or brain tumor).
* If your Brain injury is less than 6 months ago.

For healthy participants:

-If you have a history of prior neurological disorders (e.g., head injury, stroke, seizures, or brain tumor).

For All participants:

* If you have significant psychiatric history (such as schizophrenia or bipolar disorder.)
* If you have a alcohol or drug abuse history.
* If you are currently taking certain types of medications, which the study doctor will review.
* If you do not have a working knowledge of the English Language.
Retroclavicular Versus Costoclavicular Approach for Infraclavicular Brachial Plexus Block

The primary aim of this study is to compare needle shaft visibility between the retroclavicular approach and costoclavicular approach for infraclavicular brachial plexus block in patients undergoing elective upper limb surgery. Secondary aim is to investigate the differences between the two groups in sensorial block success rate, block performance time, block performance related pain, motor block success rate, surgical success rate, complications, patient satisfaction, use of supplemental local anesthetic, use of analgesic.

Infraclavicular blocks are performed with different approaches. This study evaluated the effectiveness, safety and feasibility of a retroclavicular brachial plexus block as compared with costoclavicular approach for infraclavicular brachial plexus block. 60 patients scheduled for elective upper limb surgery were recruited and randomized into two groups: Retroclavicular approach for infraclavicular block (Group I), costoclavicular approach for infraclavicular block (Group R). Sensory block, adverse effects and complications were evaluated and recorded every 5 minutes until 30 min after local anesthetic injection. Success rate of each nerve sensory block, complications, rate of satisfaction, rate of failure and incidence rate of adverse effects, the needle shaft visibility, procedure time,duration of the block's effect, use of supplemental local anesthetic, use of analgesic are compared with both groups.

Eligibility Criteria:
Inclusion Criteria:

* patients who undergo elective forearm or hand surgery under infraclavicular brachial plexus block
* American Society of Anesthesiologists class 1 to 3
* Ability to consent

Exclusion Criteria:

* History of allergic reaction to local anaesthetics
* Peripheral neuropathy
* Renal or hepatic insufficiency
* Coagulation disorders
The Effect of Different Exercise Programs in Coronary Artery Patients: A Randomized Controlled Study

There are studies showing the superiority of HIIT protocols in patients with CAD in the literature, however there is no consensus on the use of HIIT protocols in CAD patients. In addition, in these studies, the HIIT protocols differ in severity and duration and there is no optimal HIIT protocol. Therefore, this study was planed to investigate of two different HIIT protocols and one MICT protocols, which are more commonly used in patients with CAD in the literature on exercise capacity, quality of life, body composition, physical activity level and fear of movement.


Eligibility Criteria:
Inclusion Criteria:

* Have undergone percutaneous transluminal coronary angioplasty or coronary artery bypass graft surgery,
* Nonobstructive CAD registered by angiography
* Left ventricular ejection fraction above 50%,
* Clinically stable for more than 2 weeks in terms of symptoms and medical treatment.

Exclusion Criteria:

* Ischemia symptoms,
* Being in Class III-IV according to the New York Heart Classification,
* Obtaining significant left ventricular outflow obstruction,
* Ventricular arrhythmia,
* Being marked valvular heart disease,
* Failure to comply with exercise testing and training rules,
* To have significant orthopedic or neurological comorbidity that prevents full participation.
A Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder

The objective of this proof-of-concept study to evaluate mazdutide in participants with alcohol use disorder (AUD).

For any individual participant, the maximum duration of study participation is approximately 36 weeks, including screening and posttreatment follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Current AUD diagnosis as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria.

Exclusion Criteria:

* Have a history of significant active or unstable major depressive disorder, suicidal ideation, or other severe psychiatric disorder within the last 12 months.
* Have initiated psychotherapy, changed the intensity of psychotherapy, or other nondrug therapies (for example, acupuncture or hypnosis) within 8 weeks prior to enrollment.
* Have received any medication for AUD in the last 30 days including but not limited to, disulfiram, acamprosate, naltrexone, gabapentin, baclofen, or topiramate.
* Other protocol-specific inclusion and exclusion criteria may apply.
Class II Correction Study Using the Invisalign System

To demonstrate that growing teenagers which present up to full cusp Class II malocclusions can be treated using the Invisalign System.

The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for about two weeks, then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.

Eligibility Criteria:
Inclusion Criteria:

* Subject must have fully erupted dentition excluding 2nd and 3rd molars
* Age range 11-19 years old
* Subject that requires bilateral Class II correction and must require at least 3mm of correction as measured by first molar relationship

Exclusion Criteria:

* Subject who has unerupted, erupting, partially erupted dentition (except for 2nd and 3rd molars)
* Subject who has spaces between adjacent teeth larger than 3mm
* Subject with active caries
* Subject with periodontal disease
* Subject does not have at least 1st molar fully captured in PVS (polyvinyl siloxane material ) impression or intraoral scan.
* Subject with TMD (Temporomandibular joint dysfunction) symptoms
* Subject has undergone pre-treatment with any orthodontic appliance (any previous treatment prior to study)
* Subject has known allergy to latex and plastic
* Subjects who are pregnant or will become pregnant during treatment
Cohort Study of Patients With Type 1 Diabetes

This study aims to clarify the underlying hereditary and autoimmune factors that contribute to clinical type 1 diabetes and gain a better understanding of the natural history of the disease.


Eligibility Criteria:
Inclusion Criteria:

1. diabetes diagnosed according to the report of WHO (World Health Organization) in 1999;
2. insulin dependence from disease onset,thus diagnosed with type 1 diabetes;
3. all patients gave informed consent to participate in the study and the protocol was approved by the Research Ethics Committee in second Xiangya hospital, Central South University.

Exclusion Criteria:

1. secondary diabetes mellitus;
2. pregnant women;
3. malignant disease.
The Effect of Metformin on Reducing Lupus Flares

This is a multicenter, randomised, double-blind placebo controlled trial on the efficacy and safety of add-on metformin to conventional immunosuppressants in systemic lupus erythematosus (SLE).

The purpose of this study is to evaluate: 1) the effect of metformin on reducing disease flares; 2) the influence of metformin on corticosteroid sparing effect; 3) the influence of metformin on body mass index (BMI); 4) the safety of metformin.


Eligibility Criteria:
Inclusion Criteria:

* Willingness of the subject to participate in the study, proven by signing the informed consent;
* Systemic lupus erythematosus (SLE), as defined by meeting at least 4 of 11 classification criteria of American College of Rheumatology for the classification of systemic lupus erythematosus, either sequentially or coincidentally. The 4 criteria doesn't need to be present at the time of study enrollment;
* The course of SLE longer than1 year; and there is a clear record of disease flares in the past 1 year with prednisone more than 20mg/day;
* Patients with mild/moderate disease activity (score≤ 6 at screening on SLEDAI); no British Isles Lupus Assessment Group (BILAG) A or no more than one B;
* A stable treatment regimen with fixed doses of prednisone (≤ 20mg/day), antimalarial, or immunosuppressive drugs (azathioprine/ mycophenolate mofetil/ methotrexate/ ciclosporin/ leflunomide/ thalidomide) for at least 30 days.

Exclusion Criteria:

* Patients who are unwilling to sign the inform consent;
* Alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) \> 2 times upper normal limits; creatinine clearance rate \< 60ml/min;
* Patients who used cyclophosphamide 6-months before screening; used biological agents 12-months before screening;
* Previous exposure of metformin within 30 days before screening; or previous history of intolerant to metformin;
* Patients who diagnosed of diabetes mellitus;
* Pregnancy or lactation.
Traumatic Characteristics of the Forensic Cases Admitted to Emergency Department and Errors in the Forensic Reports

Objectives: to detect the mistakes and deficiencies of the forensic reports which was written and to detect the injury characteristics of the forensic cases applied to emergency service of a tertiary hospital.

All patients who applied for reasons such as crushing, traffic accidents, firearms and explosive injuries, assault, all kinds of injuries, burns, electric shock, asphyxia, torture, child abuse, falls and other injuries, poisoning and suicide attempt are a forensic case.Traumatic forensic cases are often confronted in emergency departments, Aim to this study is to detect the mistakes and deficiencies of the forensic reports which was written and also aimed to detect the injury characteristics of the forensic cases applied to emergency department which is the most important center in region at a tertiary hospital.

Eligibility Criteria:
Inclusion Criteria:

* Traumatic forensic cases which written a forensic report were included in study.

Exclusion Criteria:

* The forensic cases which can not be reached the forensic report and patients' emergency department chart
Validation of a Tolerability Questionnaire in Rheumatoid Arthritis

The purpose of the present study is to assess the measurement properties of a tolerability questionnaire. The results obtained in patients with Rheumatoid Arthritis (RA) being treated will be robust and will assess the patient's tolerability to the treatment. Patients with greater tolerability will be more satisfied with their treatment.

Clinicians do not have any standardized questionnaire to assess the tolerability from the patient's perspective. The tolerability assessment of the different pharmacological strategies for Rheumatoid Arthritis, from the patient's perspective, would provide additional information, improve doctor-patient communication and improve both adherence to and efficacy of treatment. For these reasons, the development and validation of a new tool is necessary not only for future researches, but for use in standard clinical practice.

The first phase of the development of the questionnaire has already been completed. The second phase of the development of the questionnaire has been designed at to validate the tool in the Spanish population.

This study aims to assess the measurement properties of a new tool which assesses the impact of daily life in Rheumatoid Arthritis.

Eligibility Criteria:
Inclusion Criteria:

1. Patients over 18 years old.
2. Patients with RA diagnosed according to the standards of the ACR (American College of Rheumatology) in 1987 or to the ACR/EULAR in 2010
3. Patients on treatment with any Rheumatoid Arthritis drug for at least 3 months before their inclusion in the study \*
4. Patients who have provided informed consent prior to taking part in the study.

   * It's not necessary for patients to be treated in first-line at the moment of the inclusion in the study.

Exclusion Criteria:

1. Patients with rheumatic disease other than Rheumatoid Arthritis. Will be exclude patients with the following concomitant diseases: Rheumatic autoimmune disease other than RA; Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis; Diagnosis of juvenile idiopathic arthritis; inflammatory joint disease other than Rheumatoid Arthritis.
2. Patients with any other concomitant disease or treatment that, under clinical criteria, could affect the results of the study or any major episode of infection or disease requiring hospitalization.
3. Patients with any other medical or physiological condition that, in the view of the investigator, could compromise the ability of the patient to answer the study questions.
4. Patients who participated in interviews of the Phase I (development of the questionnaire)