cyrilzakka/clinical-trials huggingface dataset:
A Post-Marketing Safety Study of Dorzagliatin in Patients With Type 2 Diabetes

The primary objective of this study is to evaluate the long-term safety of Dorzagliatin in a larger population of type 2 diabetes mellitus patients by collecting the post-marketing clinical safety data of Dorzagliatin.

This study adopts a multicenter, prospective, and observational cohort study design and does not involve randomization, control, and blinding. Patients with type 2 diabetes mellitus who were prescribed Dorzagliatin according to the package insert and physician's judgment in routine medical practice setting will be included, and the data of these patients during 52-week Dorzagliatin treatment will be collected to evaluate the safety of long-term medication.

Eligibility Criteria:
Inclusion Criteria:

-

Patients must meet all of the following inclusion criteria to be eligible for this study:

1. Male or female ≥ 18 years of age at the time of signing the informed consent form;
2. Patients with type 2 diabetes mellitus diagnosed at screening;
3. Patients who have been prescribed Dorzagliatin according to the package insert and physician's judgment (the prescription should be made before enrolling the patient in this study and is independent of the enrollment decision);
4. Willingness to participate in the study and sign written informed consent.

Exclusion Criteria:

-

Patients will not be eligible if they meet any of the following criteria:

1. Other types of clinically diagnosed diabetes, such as type 1 diabetes or other special types of diabetes;
2. Patients who, in the opinion of the investigator, are at risk of allergy or intolerance to any component of Dorzagliatin;
3. Patients who, in the judgment of the investigator, cannot complete or are not suitable for this study.
Red Light Intervention on Myopic Progression

To explore the effectiveness of using repeated low-level red-light therapy to slow myopia progression.


Eligibility Criteria:
Inclusion Criteria:

1. Age at enrolment: 6-12 years;
2. At least one eye with spherical equivalent refractions (SERs): -1.00 to -5.00 diopters (D), and stigmatism of 1.50 D or less;
3. Anisometropia of 1.5 D or less;
4. The BCVA of distant vision is at least 0.8;
5. Myopia progressed more than 0.5D in the past year;
6. Have normal thinking and language communication skills, and be able to actively cooperate with the treatment as required;
7. Written informed consent of guardian and child.

Exclusion Criteria:

1. Strabismus, amblyopia or other ocular abnormalities;
2. Other systemic abnormalities;
3. Prior treatment of myopia control in 6 months, e.g. drugs, orthokeratology, progressive addition lenses, bifocal lenses, etc in either eye;
4. Atropine allergy;
5. Other situations that not suitable for participating in the trial as judged by the researcher.
A Registered Cohort Study on Wilson's Disease

The aim of this study is to determine the clinical spectrum and natural progression of Wilson's Disease in a prospective multicenter natural history study, to assess the clinical, genetic, epigenetic features and biomarkers of patients with Wilson's Disease to optimize clinical management.


Eligibility Criteria:
Inclusion Criteria:

* Patients with the genetic diagnosis of Wilson's Disease
* Asymptomatic Wilson's Disease carriers
* Relatives of Wilson's Disease patients or carriers
* Unrelated healthy controls
* Participants or Parent(s)/legal guardian(s) willing and able to complete the informed consent process

Exclusion Criteria:

\* Participants are unable to comply with study procedures and visit schedule
Study of the Safety of Intravenous Artesunate

The purpose of this study is to establish the safety, tolerability and pharmacokinetics of a single dose of the antimalarial drug artesunate.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult males and non-pregnant, non-lactating females
* Have a normal ECG that may include benign PAC's and PVC's, 1st degree AV block, 2nd degree AV block, Wenckebach
* Have a normal blood pressure (BP) and heart rate (HR). These will be measured after resting supine for about 3 minutes. Normal BP is defined as less than 140 mm Hg systolic and less than 90 mm Hg diastolic. Normal baseline HR is 50 to 90 bpm without symptoms.
* Body mass index between 18 and 29 kg/m\*\*2 or, if out of range, not clinically significant (within 15% of their ideal body weight).
* Be able to verbalize understanding of the consent form, provide written informed consent and verbalize willingness to complete study procedures
* Have a brief physical examination that demonstrates no clinically significant contraindication for participating in the study.
* If female, have a negative serum pregnancy test at screening and urine pregnancy at admission or be postmenopausal, had a hysterectomy, been sterilized, or agrees to practice effective contraception for the duration fo the study and for a period of 12 weeks after stopping study drug.

Exclusion Criteria:

* Have received any investigational drug or vaccine in the period 0 to 16 weeks before entry to the study.
* Have been on a liquid protein diet in the last year
* Have any clinically significant abnormal physical findings at the screening examination
* Have any clinically significant abnormalities in the results of laboratory screening evaluation
* Have used any prescription drugs within 14 days prior to admission or non-prescription drugs (including herbals or dietary supplements) within 7 days prior to admission
* Existence of any surgical or medical condition that, in the judgement of the clinical investigator, might interfere with the distribution, metabolism or excretion of the drug
* Presence of history of drug allergy requiring treatment. Hay fever is allowed unless it is active or has required treatment within the previous 2 months
* Donation or loss of greater than 400 ml of blood in the period 0 to 12 weeks before entry to the study.
* Serious adverse reaction or hypersensitivity to any drug, particularly artemisinins
* CAGE (screening test for alcoholism) positive (2 out of 4 criteria) or has a history of recent alcohol abuse
* Use of illicit drugs
* Family history of sudden cardiac death or prolonged QT syndrome (defined as 500 msec noted in repeat tracings)
* History of seizure, syncope, or trouble with hearing or balance or other neurological disorder
* History of severe psychiatric disorder or hospitalization for severe psychiatric disorder
* Current job or personal habit of reversed sleep-wake cycle
* History of cardiac disease to include cardiomyopathy, valvular disease, arrhythmia, ischemia, or enlarged heart
* Presence of hepatitis B surface antigen (Hbs-Ag), hepatitis C antibody (antiHCV) or HIV type 1 at screening
* Pregnancy
Self-adherent Absorbent Silver Dressing in Adults After Hip or Knee Arthroplasty

The overall rationale for this investigation is to evaluate the clinical performance potential for Mepilex Border Post-Op Ag in the ability to minimize the risk of skin related post-operative wound complications such as blistering, maceration and redness at the incision and surrounding skin.

This was a descriptive, open, prospective, non-controlled clinical investigation conducted on 21 enrolled subjects at one site in the United states of America (USA).

The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty with a possibility to participate in a follow-up visit 7 days after surgery. The primary purpose was to investigate if there was any skin damage under the dressing from operation day to last visit. Performance of the dressing as well as comfort, conformability, acceptability and pain at dressing removal was also followed-up until post-op day 7.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Available for a follow-up visit including dressing change 7 days after surgery
3. Plan for elective primary hip or knee arthroplasty
4. Plan for incision size ≤18 cm
5. Provision of informed consent i.e. subject must be able to understand and sign the Patient Information and Consent Form
6. Undergoing elective primary arthroplasty of the hip or knee.

Exclusion Criteria

1. Known allergy/hypersensitivity to any of the components of the dressing
2. Multi-trauma
3. Undergoing arthroplasty due to tumor
4. Previous incision at the same knee or same side of the hip
5. Wound at the surgical site prior to surgery
6. Neurological deficit of operated side (hemiplegia, etc.)
7. Documented skin disease at time of enrollment, as judged by the investigator
8. Previously enrolled in the present investigation
9. Inclusion in other ongoing investigations at present that would preclude the subject from participating in this investigation as judged by the investigator
10. Involvement in the planning and conduct of the clinical investigation (applies to all MHC staff, investigational site staff and third party vendor)
11. Dressing size does not fit the incision area (\>18 cm)
12. Complications that would increase wound risks if investigational dressing is applied
Combining Registry Data in Haemophilia: TARGET H

This is an investigator-initiated, multinational, retrospective, non-interventional pilot study conducted in five haemophilia treatment centres from different geographical regions that maintain a local (Algeria, Malaysia) or national (India, Iran, South Africa) haemophilia registry. Data from a randomly selected sample of patients from national or local registries are anonymously collated and analysed.The aims are to determine the feasibility of combining data from national and local registries in countries with developing healthcare systems and to assess how existing registries implemented current recommendations for data collection in terms of available fields and their completion.

The study is conducted in five haemophilia treatment centres (HTCs) from different geographical regions (Algeria, India, Iran, Malaysia and South Africa) that maintain a local or national haemophilia registry. Data will be collected from 20 randomly selected, active patient records from each participating registry/country. In countries with national registries, data from local registries will not be permitted for inclusion to allow adequate assessment of the possibility of registry harmonisation across various regions. Participating centres will report data as available in the data source without seeking additional information to fill source data gaps at the time of data collection. In addition, each investigator will complete a basic questionnaire on feasibility parameters to confirm the source and accuracy of the data, as well as challenges experienced during data collection. Analysed parameters will be grouped into three categories: sociodemographic, disease, and treatment and disease outcome parameters. Feasibility assessment will be performed for all study variables and the percentage availability of each study variable recorded in the participating registries wii be determined, as well as the proportion of missing data for existing variables.

Eligibility Criteria:
Inclusion Criteria:

* male
* diagnosis of haemophilia A or B
* with or without inhibitors
* no other inherited bleeding disorder
* active patient record
* willing and able to provide written consent

Exclusion Criteria:

- unwilling or unable to provide written consent
Transversal, Controlled and Not Randomized Study, Laying on the Desire of Children and Eating Disorders in a Population of Infertile Women

In France , 15% of couples seek help for problems conceiving . In 10% of cases, infertility remains " unexplained" . Among the causes of female infertility , there are the eating disorders, as well as sexual disorders , these two cases may be linked. In addition, data from the literature seem to suggest that beyond a diagnosis of eating disorders, the feeding behavior of infertile women is more often disturbed than the general population. Moreover, the notions of desire for a child and maternal representations seem essential to address in the comprehensive care of women with infertility but also TCA integrating all conflicting issues reactivated at the time of motherhood. However, little work has been done on this subject. Thus, we propose a study on the desire for children and the eating disorders to infertile women, to update epidemiological data, but also to better characterize this particular patient population. Perspectives of this work are to improve screening measures and support through a joint work of doctors reproductive and psychiatrists.


Eligibility Criteria:
Inclusion Criteria:

* Women
* Major
* In a relationship
* Infertile (WHO criteria)
* Consultant in the Department of infertility (BMDR) for AMP
* Understanding of French, literate
* Agree to participate in the study

Exclusion Criteria:

* Man
* Minor
* Pregnancy at the time of assessment
* Exclusive Infertility spouse
* Disorders of higher functions (severe cognitive impairment or confusion) or psychosis (hallucinations, delusional syndrome)
* Major protected
Silver Agri Age: Longevity, Intrinsic Capacity and Cognitive Impairment Into Farmlands and Natural Environments: Updating Contexts Following the "Montessori" Action

This project aims to enhance the intrinsic capacities of elderly individuals with mild cognitive impairment by promoting innovative activities based on the Montessori approach within the context of agricultural multifunctionality.

By selecting a rural environment with educational characteristics, we aim to involve individuals with mild cognitive deficits and their families in a personalized therapeutic journey. Through various activities, including horticulture, pet therapy, occupational therapies, sensory and food laboratories, we stimulate cognitive and motor skills, promoting a healthy and balanced lifestyle

Promoting innovative activities following the "Montessori" action in the context of the agricultural multifunctionality, in order to leverage the intrinsic capacity in older people with cognitive impairment.

* Identifying a rural environment with educational features.
* Identifying individuals with mild cognitive impairments and relations with their families.
* Outlining individual therapeutic goals for each participant through different activities:

horticulture, pet therapy, occupational therapies, sensory laboratories, functional food laboratories for a healthy and balanced diet suitable for the first symptoms of dementia, physical activity and continuous social activity between different generations.

* Horticulture, pet therapy, occupational therapy, sensory labs, physical activity, and social activities IN CONTINUITY between different generations.
* Spreading the results to a wide National and International audience.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of mild cognitive impairment (MCI);
* Mini Mental State Examination ≥ 24;
* ability and willingness to sign informed consent

Exclusion Criteria:

* Mini Mental State Examination \< 24;
* severe visual impairment;
* inability to walk without help or assistance, Tinetti's scale \<20
Using Infrared Spectroscopy to Analyze Volatile Organic Compounds (VOCs) in the Breath of Patients With Lung Cancer

The goal of this clinical trial is to compare breath samples from patients with lung cancer, those with stable lung nodules, and individuals without lung cancer. The main questions it aims to answer are whether breath patterns are different in these groups and to see if breath patterns change after treatment in patients with lung cancer.

Participants will be asked to provide one breath sample, and two if they get treated. They will also be asked to fill out a questionnaire about their background and medical history.

Globally, lung cancer accounts for the most cancer deaths in both sexes combined. It is believed to develop slowly through progressive accumulation of genetic mutations, hence the disease allows time for diagnosis and curative surgical treatment. Five year survival rates for non-small-cell lung carcinoma (NSCLC) can range from 57-61% when detected in the early stages of disease. This is compared with a survival rate of approximately 6% once distant metastases are present. However, disease diagnosis typically occurs when it has progressed to an advanced stage when patients present with signs and symptoms. Therefore, technologies capable of asymptomatic disease detection will significantly impact lung cancer specific mortality. Metabolomic profiling of cancer measures compounds produced as a result of cellular activity including volatile organic compounds (VOCs) in exhaled breath. Infrared spectroscopy is a proven technique for breath analysis that can measure chemical concentrations in the parts per trillion range for certain VOCs. When coupled with machine learning techniques, this has the potential to be a novel approach for disease detection using exhaled breath.

Eligibility Criteria:
Inclusion Criteria:

Study participants in the lung cancer and control cohorts must meet lung cancer screening criteria as defined by the PLCOm2012 and/or US Preventative Services Task Force (USPSTF) risk criteria.

Exclusion Criteria:

* Patients are not eligible if they are currently receiving treatment for lung cancer.
* Patients are not eligible for a second breath sample if it has been less than 6 months since last application of treatment.

Note: Breath sampling technology is sensitive to chemicals produced by tobacco, cannabis and e-cigarettes as well as alcohol (consumed by the subject or used by the operator around the equipment). We ask participants to refrain from:

* Smoking (tobacco, cannabis or e-cigarettes) at least 4 hours before breath sampling;
* Consume alcohol (including mouthwash) at least 8 hours before breath sampling.
Covid -19 Pandemic: Economic Burden on Patients Operated for Traumatic Close Fractures

Covid-19 has adversely impacted the health care organizations by over burdening with Covid patients and suspending the elective surgeries and clinics A single center retrospective study was conducted to quantify losses due to postponement of elective surgeries and extra cost for procurement of PPEs. The secondary objective was to see the effect of Covid -19 on the total costs of inpatient care during Covid era.

Covid-19 has impacted adversely the economy of Pakistan that has already poor and challenged socioeconomic conditions This is a single hospital retrospective cross sectional study conducted to quantify losses due postponement of elective surgeries and procurement of PPEs and see the effect of Covid -19 on the total costs of inpatient care during Covid era.

We included all the patients admitted in orthopedic section for operative intervention of fractures and elective procedures from January 1, 2020 to May 31, 2020. We divided this period into two halves; the first half was from January first to March 15 named as PreCovid Era and second half was from March 16, to May 31, 2020, termed as Covid Era. The total number of trauma procedures and elective procedures were compared in both eras. We compared six procedures each from upper and lower limit for cost analysis and length of stay. We also analyzed the extra cost for procurement of PPEs.

Eligibility Criteria:
Inclusion Criteria:

* All the patients admitted in orthopedic section for operative intervention of fractures and elective procedures from January 1, 2020 to May 31, 2020.

Exclusion Criteria:

* Patients presenting with other bone morbidities that did not require surgical interventions including rickets, osteomalacia, osteogenesis imperfecta, marble bone disease (osteopetrosis), Paget disease of bone, and fibrous dysplasia, patients with incomplete medical records were excluded from the study.
A Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)

The primary objective of this study is to describe the long-term safety and tolerability of rocatinlimab in participants with moderate-to-severe AD.


Eligibility Criteria:
Inclusion Criteria:

* Completion of an end of treatment duration visit (Week 24 or Week 52 visit for adult or adolescent studies, respectively) in a rocatinlimab parent study (ROCKET-IGNITE, ROCKET-HORIZON, ROCKET-SHUTTLE, ROCKET-ASTRO, ROCKET-ORBIT, OR ROCKET-VOYAGER) within the past 28 days.
* Participants from the parent study ROCKET-ORBIT must achieve an improvement in EASI score at week 52 of at least 60% compared to parent study baseline (EASI 60).

Exclusion Criteria:

* Permanent investigational product discontinuation due to safety-related reasons, protocol-defined stopping rules or conditions/reasons unrelated to efficacy during the rocatinlimab parent study (ROCKET-IGNITE, ROCKET-HORIZON, ROCKET-SHUTTLE, ROCKET-ASTRO, ROCKET-ORBIT, OR ROCKET-VOYAGER), or at the time of Screening or Day 1.
Recovery After Total Hip Arthroplasty

This is an observational prospective study aimed to assess the lower limbs motor and functional recovery in patients who underwent to unilateral THA respect to simultaneous bilateral THA, in early postoperative phase.

Introduction: Total hip arthroplasty (THA) represents a successful treatment for several hip joint pathologies. In case of bilateral hip joint involvement, the advancements in surgical techniques have made the development of bilateral THA surgery possible through one-stage procedure. This approach seems to be as safe as unilateral THA and safer than two-stage bilateral THA, but few studies considering functional outcomes in these patients without exploring outcomes linked to their motor and functional performance.

Objective: the aim of the study is to assess the lower limbs motor and functional recovery in patients who underwent to unilateral THA respect to simultaneous bilateral THA, in early postoperative phase.

Methods: 20 patients underwent to unilateral THA and 20 patients underwent to simultaneous bilateral THA will be recruited in the study. The partecipants will be aged from 40 to 65 years old, they will be undergone to primary THA for arthritis and the will be able to walk for 50 m without aids. Patients with severe dysplasia (Crowe III and IV), anchylosis, sub-anchylosis or surgical fusion of the coxophemoral joint, with traumatic event, or previous femoral and / or pelvic osteotomy, will be excluded from the study. Weight distribution and postural stability will be evaluated asking to participants to stay on two stabilometric platform with open eyes and closed eyes for 45 seconds. Gait analysis will be used to evaluate the spatio-temporal gait parametres and the ankle, knee, hip and pelvic kinematic. Pain during walking and patients' walking ability will be also evaluated throught Numeric Rating Scale (NRS) and Timed Up and Go test (TUG). Outcome measures will be collected the day before surgery, after three, seven and about forty days after surgery, except for gait analysis and Time Up and Go tests, which will not be recorded after three days.

Statistical analysis: normality and homogeneity of demographic variables and outcome measures at the baseline will be verified. Intergroup and intra-group post-intervention differences related to outcome measures will be investigated through ANOVA for repeated measurements including post hoc analysis.

Eligibility Criteria:
Inclusion Criteria:

* from 40 to 65 years old
* primary THA for osteoarthritis
* ability to walk for 50 m without aids

Exclusion Criteria:

* severe dysplasia (Crowe III and IV)
* anchylosis, sub-anchylosis or surgical fusion of the coxophemoral joint
* traumatic event
* previous femoral and / or pelvic osteotomy