cyrilzakka/clinical-trials huggingface dataset:
Phase IV EORTC Quality of Life Module for Patients With Chronic Myeloid Leukemia

The objective of this study is to test the scale structure, reliability, validity and responsiveness to change of the QLQ-CML24 in conjuction with the QLQ-C30 for patients diagnosed with CML, and to investigate longitudinal relationship between satisfaction with information provision and QoL outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Above 18 years of age.
* Patient with confirmed diagnosis of Philadelphia chromosome positive and/or BCR-ABL positive chronic myeloid leukemia (CML).
* Written informed consent.
* Patients enrolled in investigational drug-trials or other type of clinical trials are also eligible.

Exclusion Criteria:

* Patients with a psychiatric condition or major cognitive impairment (as evaluated by their treating physician) that would hinder completion of self-reported health-related QoL questionnaires.
* Patients who are unable to speak and read the language of the questionnaire.
Efficacy and Safety of Enzyme Replacement Therapy in Patients with Fabry Disease

The goal of this observational study is to learn how enzyme replacement therapy works in patients with Fabry disease. The main question it aims to answer is:

What medical problems do participants have?

Participants already on enzyme replacement therapy as part of their regular medical care for Fabry disease will be observed as usual. Their data will be collected by their doctor.

All patients on enzyme replacement therapy could be enrolled in the study. Three medicines are currently available in Russia (Fabagal®, Fabrazyme®, Replagal®) so the patients form three cohorts.

For all patients retrospective data are collected for 12 months prior enrollment.

All patients are observed prospectively for 6 months. At the point of 6 months patients taking Fabrazyme or Replagal at the moment finish the study.

Patients on Fabagal are observed for 12 more months (up to 18 months after enrollment).

Eligibility Criteria:
Inclusion Criteria:

* Men and women with a confirmed diagnosis of Fabry disease;
* Prescribed course of enzyme replacement therapy with any drug (FABAGAL, FABRAZIM, REPLAGAL);
* Age 8 - 65 years;
* Signed informed consent of the patient and/or his/her legal representative for participation in the study and processing of personal data.

Exclusion Criteria:

* Renal replacement therapy or kidney transplantation;
* Critical illness unrelated to Fabry disease;
* Pregnancy or breastfeeding;
* Refusal of the patient (or his/her legal representative) from further participation in the study or medical care.
Assessing the Effects of HbA1c Reduction on Alleviating Nonspecific Back Pain

Prediabetes, characterized by elevated HbA1c levels, is a common precursor to type 2 diabetes mellitus. Recent studies have suggested a potential link between prediabetes and nonspecific back pain. This randomized controlled trial aimed to assess whether reducing HbA1c levels through lifestyle interventions and, along with the correction of vitamin D and magnesium, can alleviate nonspecific back pain in prediabetic patients.

The study included 40 patients from an outpatient clinic in Baghdad, evenly divided into intervention and control groups. The intervention group underwent a 6-month lifestyle modification program, focusing on diet, sleep, exercise, and vitamin D and magnesium correction. HbA1c levels were measured, and back pain severity was assessed (through what assessment method ?). The control group received standard care with NSAIDs and acetaminophen for pain management. Assessments were conducted at baseline and at various intervals over a total period of 6 months to evaluate changes in HbA1c levels and back pain intensity.

This randomized controlled trial provides evidence that reducing HbA1c levels through lifestyle modifications, along with the correction of vitamin D and magnesium, can lead to a reduction in nonspecific back pain intensity and improved functional outcomes in prediabetic patients.

Eligibility Criteria:
Inclusion Criteria:

* Poor sleep (less than 6 hours per day)
* chronic back pain
* Multiple joint pain
* non-specific back pain
* HBA1C more than 5.7
* ability to record the data

Exclusion Criteria:

* Not able to record data
* previous spine surgeries
* severe OA in knee
* Spinal stenosis
* Peripheral vascular diseases
* Rheumatological diseases
* Lumbar disc prolapse
* uncooperative patient
Electromyographic Analysis And Body Balance In The Use Of Athletes After Cryotherapy By Immersion Ankle

The influence of cryotherapy on ankle motor control and balance of athletes is controversial. The aim of this study is to assess the neuromuscular response of the dominant leg and body balance basketball athletes after application of cryotherapy. The sample is distributed into two groups. Group one will consist of 20 basketball players without a history of ankle sprains in the past 12 months and no complaints of instability in this joint, and group two, 20 non-athletes, active, no complaints in the lower limb in the last 12 months. Will perform the inversion movements and single-leg hop for the analysis of the electromyographic signal of anterior tibial, peroneal, gastrocnemius (lateral), rectus femoris, hamstrings and gluteus medius. Will also be performed kinematic analysis in search of body balance and range of motion of the joints of the lower limbs. And yet, the analysis of the plantar support and ground reaction force. After the initial collection of the data subjects will be submitted to the application of cryotherapy by immersion in a time of 20 minutes, with a temperature of 6 ± 2 degrees Celsius. Data collection will be held in pre, 0, 10, 20 and 30 minutes after application of cryotherapy. The data will be statistically analyzed to compare the results in collection times within and between groups. The significance level is set at 5%. The data support the intended use of cryotherapy in motor control of the inversion movement, jump and balance of athletes.

Forty male subjects, aged 21.6 (±3.2) yr, 177.9 (±7.9) cm tall, 82.8 (±19.3) Kg body weight and 25.9 (±4.8) Kg.m-2 body mass index (BMI) were evaluated. Skin surface temperature before and after cold-water immersion was 27.7(±3)°C and 7.1 (±1)°C, respectively (p=0,0001).

Eligibility Criteria:
Inclusion Criteria:Healthy, active individuals and athletes basketball. -

Exclusion Criteria:patients with muscle or joint injuries in the lower limbs in the last six months; metabolic diseases, rheumatic and orthopedic disabling; patients with balance disorders or cognitive; individuals to submit complaints of muscle fatigue at the time of the tests or they needed the use of stabilizers to realize them; subjects with skin lesions of the lower extremities, hypersensitivity to cold and suffering from Diabetes Mellitus.

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Long-term Impact of Inhaled Tobramycin for Pseudomonas Aeruginosa Eradication in Bronchiectasis (ERASE II)

The ERASE II study is a prospective follow-up study designed to assess the long-term impact of successful eradication of Pseudomonas aeruginosa (PA) in patients with bronchiectasis. Building on the findings of the initial ERASE study, which evaluated the efficacy and safety of Tobramycin Inhalation Solution, ERASE II aims to determine whether successful PA eradication influences patient prognosis over an extended period.

The study will involve a total observation period of 36 months, consisting of the initial 9 months of the ERASE study followed by an additional 27 months of comprehensive follow-up. Key outcomes to be assessed include patients' quality of life, lung function, frequency of pulmonary exacerbations, frequency of hospitalization, and overall treatment costs. Additionally, the study will examine the timing and incidence of any potential reinfections with Pseudomonas aeruginosa.

Individuals with bronchiectasis are particularly susceptible to infections from Pseudomonas aeruginosa (PA), which can become chronic and lead to increased mortality and disease severity. To address this critical issue, we have designed a multi-center, 2×2 factorial randomized, double-blind, placebo-controlled trial known as the ERASE study. This trial aims to evaluate the efficacy and safety of Tobramycin Inhalation Solution in the eradication of Pseudomonas aeruginosa in bronchiectasis patients with newly or firstly isolated PA.

Building upon the findings of the ERASE study, the ERASE II study seeks to investigate whether successful eradication of PA influences the long-term prognosis of patients after the completion of the randomized controlled trial. To achieve this, we plan to extend the observation period to a total of 36 months, comprising the initial 9 months of the ERASE study, followed by an additional 27 months of comprehensive follow-up.

This extended observation period will enable us to assess the long-term impact of eradication therapy on various clinical outcomes, including patients' quality of life, lung function, frequency of pulmonary exacerbations, frequency of hospitalization, and overall economic treatment costs. Additionally, we will evaluate the timing of any potential reinfections/relapse with Pseudomonas aeruginosa, thereby providing valuable insights into the long-term benefits of eradication strategies in patients with bronchiectasis.

Eligibility Criteria:
Inclusion Criteria:

* all patients who participate the ERSE study
* write the informed consent form.

Exclusion Criteria:

* patients who were lost of follow up in the ERASE study
* ineligible for inclusion at the discretion of the researcher for other reasons.
From Short-term Surgical Missions Towards Sustainable Partnerships

Introduction: Recently, the devastating consequences of neglected surgical care in global health became apparent with an estimated five billion people lacking access to safe surgical and anesthesia care. Traditionally, short-term surgical missions were the predominant strategy how surgical care was supported in Low- and Middle-Income Countries. Although surgical missions have been criticized in recent literature they are still being performed on a large scale. The aim of this study is to provide recommendations for persons and organizations involved in surgical mission on how to strengthen surgical care in LMICs in the future.

Method: An online survey was developed for members of foreign teams. Data was collected on 5 topics, consisting of: 1) basic characteristics of the missions, 2) main activities, 2) follow-up and reporting, 3) the local registration process for foreign teams and 4) collaboration with local stakeholders.


Eligibility Criteria:
Inclusion Criteria:

Members of foreign teams, that did participate in at least one short-term surgical mission in a hospital in a LMIC

Exclusion Criteria:

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Study of Rebamipide Eye Drops to Treat Dry Eye

The purpose of this study is to determine the potential safety and effectiveness of rebamipide eye drops, an investigational eye drop being developed for the treatment of keratoconjunctivitis sicca (dry eye).

There is a need for effective therapy for dry eye that treats the underlying cause of the syndrome. The goal of this study is to assess the impact of rebamipide on dry eye symptoms.

Eligibility Criteria:
Inclusion Criteria:

* must have symptoms of dry eye for a minimum of 6 months
* must be able to sign and date an informed consent

Exclusion Criteria:

* presence of anterior segment disease
* glaucoma or ocular hypertension
* using Restasis
* use of topically instilled ocular medications during study
* use of contact lenses
* history of ocular surgery within 12 months
* females who are pregnant, breast feeding, or child-bearing potential and not willing to remain abstinent or use contraception
* presence of Stevens-Johnson syndrome
* any anticipated change in medication through-out study
* concurrent involvement in another study or previous receipt of this drug
* cannot be safely be weaned off of ocular medications
Utility of Single-dose Oral Antibiotic Prophylaxis in Prevention of Surgical Site Infection in Dermatologic Surgery

The purpose of the study is to assess the effectiveness of a single dose of preoperative antibiotic in reducing surgical site infections in certain dermatological procedures. Patients will undergo surgical excision or Mohs surgery as is clinically indicated and part of usual care. The study will be a double blinded, placebo-controlled clinical trial. Patients meeting inclusion criteria will be assigned to one of three participant categories: 1) patients undergoing repair with skin flap or graft on the nose, 2) patients undergoing repair with skin graft, flap, or wedge resection on the ear, or 3) patients undergoing Mohs surgery with closure or partial closure or surgical excision on the lower extremity below the knee. Within each category, participants will be randomized into one of two groups: group one will receive a preoperative placebo pill and group two will receive preoperative antibiotic prophylaxis (either a single dose of Cephalexin 2g PO or single dose of Clindamycin hydrochloride 600 mg PO if allergy to penicillin or cephalosporin).

Patients will followed for 30 days +/- 7 after surgery to evaluate for any surgical site infection.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* presenting to Carilion Clinic Dermatology and Mohs surgery in Roanoke, VA at Riverside 1
* suspected to undergo a single-staged repair including a skin flap or graft on the nose
* OR suspected to undergo single-staged repair including a skin graft or flap or wedge resection 1 on the ear
* OR undergoing Mohs with closure or partial closure or surgical excision on the lower extremity below the knee

Exclusion Criteria:

* patients with intellectual or mental impairment affecting ability to give informed consent
* use of any antibiotic (other than intervention) within 48 hours of the surgery suspected infection at time of surgery
* inability to take cephalexin or clindamycin hydrochloride due to allergy or intolerance current inflammatory skin disease affecting the surgical site
* Patients undergoing concurrent surgery to oral or nasal mucosa
* Patients who have had a recent prosthetic joint surgery within two years and have been told they require antibiotic prophylaxis.
* Patients who are currently pregnant, concerned they could be pregnant, actively trying to conceive, or missed last menstrual period that is not explainable by a birth control method.
A Proof of Concept Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS)

The primary study objective is to assess the safety of afamelanotide while the secondary objective is to assess whether the therapy affects the size of the penumbra, by increasing blood flow, restoring oxygen supply to the brain, and reducing the amount of cerebral oedema (fluid) which is seen as a result of the stroke. Positive findings would indicate that the drug is able to support brain tissue-at-risk and provide overall neuroprotection and benefit to stroke patients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects with a diagnosis of first AIS due to distal \[M2 segment and beyond\] occlusion or perforator occlusion
* Perfusion abnormalities observed on Computed Tomography Perfusion (CTP)
* Mild to moderate stroke severity
* Pre-stroke mRS \<4
* Written informed consent obtained from patient and/or medical treatment decision maker prior to study-start (upon admission).

Exclusion Criteria:

* Administration of intravenous thrombolytic therapy in distal occlusion as etiology of AIS
* Intervention by endovascular thrombectomy (EVT)
* Known allergy or anaphylaxis to adrenocorticotropic hormone (ACTH) or melanocortins or any of the excipients listed in the Investigator's Brochure
* Any evidence of hepatic (defined as three times standard range) or renal impairment (defined as estimated glomerular filtration rate (eGFR) \<50 mL/min/1.73 m²)
* Any other medical condition which may interfere with the study protocol
* Female who is pregnant (confirmed by positive serum beta human chorionic gonadotropin (β-HCG) pregnancy test prior to baseline) or lactating
* Females of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide, intrauterine device) or a lifestyle excluding pregnancy
* Unable to undergo MRI brain evaluation
* Not suitable for trial participation according to judgment of the Principal Investigator (PI)
* Patients starting afamelanotide 24 hours or more from ictus.
Bioequivalence Study of Metformin Hydrochloride 500 mg Film-Coated Tablets in Indonesia Healthy Subject

The objective of this present study was to investigate whether Glufor® 500 (metformin hydrochloride 500 mg) film-coated tablets manufactured by PT. Pyridam Farma Tbk is bioequivalent to its reference product, Glucophage® 500 mg film-coated tablets manufactured by PT. Merck Tbk, Indonesia under licensed Merck Sante SAS, France.

Twenty-four subjects were given a single dose of 500 mg Metformin film-coated tablet of either formulation (test or reference) with 240 mL of a 20% glucose solution in water.

Eligibility Criteria:
The inclusion criterias were healthy male or female subjects who/with:

* had read the subject information and signed informed consent documents
* age range from 18 - 55 years
* body mass index between 18 - 25 kg/m2
* had a normal electrocardiogram
* had the blood pressure within normal range (systolic 90-120 mmHg and diastolic 60-80 mmHg)
* had the heart rate within normal range (60 - 100 bpm)
* had absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening.

Exclusion criterias

The subjects' exclusion criterias for the study were:

* those who were pregnant and/or nursing women.
* those with history of contraindication or hypersensitivity to metformin or other antidiabetic agent or other ingredients in the study products or a history of serious allergic reaction to any drug, a significant allergic disease, or allergic reaction.
* those with a history or presence of medical condition which might significantly influence the pharmacokinetic of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease.
* those with a history or presence of any coagulation disorder or clinically significant hematology abnormalities.
* those who were using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetic of the study drug, within one week prior to the drug administration day.
* those who had participated in any clinical study within 3 months prior to the study (\<90 days).
* those who had donated or lost 300 ml (or more) of blood within 3 months prior to the study.
* those who smoked more than 10 cigarettes a day
* those with a history of travelling to another city within the last 14 days
* those with a history of direct contact with a COVID-19 positive person in the subject's neighbourhood
* those with a history or present of sore throat, fever (with temperature more than 37°C) or dyspnea with in the last 14 days
* those who are positive to SARS CoV-2 antigen test
* those who were positive to HIV, HBsAg, and HCV tests (to be kept confidential).
* those with a history of drug or alcohol abuse within 12 months prior to screening for this study.
* those who were unlikely to comply with the protocol, e.g uncooperative attitude, inability to return for follow up visits, poor venous access.
An Open-label Study on the Clinical Efficacy of rTMS Intervention in PD

To demonstrate that intervention targeting the supplementary motor area (SMA) using precise navigation positioning can effectively improve motor symptoms in patients with Parkinson's disease.

As an innovative non-invasive neuromodulation technology, repetitive transcranial magnetic stimulation (rTMS) has demonstrated efficacy in improving motor symptoms in patients with Parkinson's disease (PD). The supplementary motor area (SMA) has been identified as a brain region significantly associated with motor symptoms in PD patients. However, no large-sample clinical studies have yet established the clinical efficacy of rTMS, guided by neuroimaging navigation, targeting the SMA in patients with Parkinson's disease.

We describe a open-lable study designed to recruit 20 patients with idiopathic Parkinson's disease. Participants will be randomly assigned to receive either real stimulation or sham stimulation, with the left SMA undergoing 7 days of continuous theta burst stimulation (cTBS). The primary outcome measure is the change in the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III scores from baseline to post-treatment and follow-up. Secondary outcomes include changes in scores on other clinical symptom scales.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥40 years old
2. Meet Movement Disorder Society standards;
3. Have no history of drug adjustment within 4 weeks before and during treatment;
4. The MDS-UPDRS Ⅲ score ≥8, and the Hoehn-Yahr rating is 1-4
5. MMSE ≥24，able to cooperate with the completion of behavioral tests and transcranial magnetic stimulation therapy.

Exclusion Criteria:

1. Head MRI/CT ruled out focal brain injury or severe leukoencephalopathy (Fazekas grade 3);
2. Various secondary parkinsonism syndromes (vascular parkinsonism, Parkinsonism combined with parkinsonism, drug parkinsonism, etc.);
3. Severe craniocerebral trauma, received craniocerebral surgery or deep brain stimulation treatment;
4. There are ferromagnetic implants in the body, such as cochlear implants, cardiac pacemakers, etc.
5. The person or first-degree relatives have a history of epilepsy, unexplained loss of consciousness, or are taking anticonvulsant drugs to treat epileptic seizures;
6. Diagnosed with a neuropsychiatric disorder other than PD
7. Have a history of drug abuse or drug use;
8. Participants in any clinical trial within the previous 6 month;
9. Pregnant/lactating women or subjects (including men) who have a birth plan within 6 months;
10. Other conditions deemed unsuitable for inclusion by the investigator.
HPV Genotype Attribution and Disease Burden of Anal Cancer in China

To demonstrate HPV prevalence and its genotype distributions in anal cancer in China and to describe demographic and clinical features of HPV-related anal cancer in China; To describe the epidemiological characteristics ,trends and of disease burden of anal cancer in China


Eligibility Criteria:
Inclusion Criteria:

* (1) Patients diagnosed with anal cancers, (2) Patients without radiation or chemotherapy prior to specimen collection;

Exclusion Criteria:

* (1) Patients with HIV infection, (2) Patients with immunosuppression after solid organ transplantation, (3) Those who do not agree to specimen collection and testing, (4) For retrospective study cases, those who without specimen.
Effects of Immunosuppression on HCV Recurrence After Living Donor Liver Transplantation - Comparative Study Between Tacrolimus + MMF and Tacrolimus + Steroid

The aim of this study is to compare immunosuppression protocol of tacrolimus + MMF with that of tacrolimus + steroid for preventing recurrence of hepatitis C after living donor liver transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Recipient of living donor liver transplantation for HCV-related cirrhosis

Exclusion Criteria:

* ABO blood type incompatible transplant case
* Renal dysfunction (serum creatinine \>2.0 mg/dL)
* WBC \< 1,000/mm3
* Hemoglobin \< 8 g/dL
* Platelet \<30,000 /mm3