cyrilzakka/clinical-trials huggingface dataset:
Self Biophysical Profile Using a Home Ultrasound Device Proof of Concept

The objective of this study is to assess if patients presenting for antenatal testing can complete a Bio Physical Score (BPP) with a home-use ultrasound with remote clinician guidance.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Singleton pregnancy
* Gestational age ≥ 24 0/7 weeks
* No known major fetal or genetic anomalies (may include: isolated pyelectasis, isolated --VSD, multicystic dysplastic kidney, cleft lip/palate, club foot, etc.)
* Ability to understand and sign informed consent in English
* Ability to read and understand instructions in English
* Ability to hold an ultrasound probe and respond to clinician instructions
* BMI less than 40 at initial prenatal visit
* Scheduled biophysical profile (BPP)
* Any maternal/pregnancy complications requiring antenatal testing, including but not limited to intrauterine growth restriction, chronic or gestational hypertension, preexisting or gestational diabetes, autoimmune disorder, etc.

Exclusion Criteria:

* Multiple gestation
* Known major fetal structural anomaly or aneuploidy
* Known fetal or genetic anomalies
* Ruptured membranes
* Uterine complaints, such as painful contractions
* Maternal concern for decreased fetal movement
* Not evaluated vaginal bleeding (not including spotting)
* Fetal or maternal criteria that require urgent delivery
* BMI ≥ 40 at initial prenatal visit
A Clinical Trial on Safety and Efficacy of CBT-001 in Patients With Pterygium

The objective is to evaluate the safety and efficacy of low dose and high dose CBT-001 eye drop dosed twice daily for 24 months compared to vehicle in reducing conjunctival hyperemia and preventing pterygium progression in eyes with pterygia.

Clinical Hypotheses:

1. CBT-001 dosed twice daily is more effective than vehicle in:

   * Reducing conjunctival hyperemia by demonstrating a statistically significant difference and clinically relevant improvement in the mean severity grade change from baseline.
   * Preventing pterygium progression, by demonstrating a statistically significant and clinically relevant improvement on drug vs vehicle mean difference in the change in pterygium length from baseline.
2. CBT-001 dosed twice daily maintains the above efficacies and has an acceptable ocular and systemic safety and tolerability profile when administered topically.

Eligibility Criteria:
Inclusion Criteria:

Pterygium with conjunctival hyperemia

Exclusion Criteria:

Pterygium removal within the last 6 months
Feasibility and Impact of Malaria Rapid Diagnostic Tests in the African Retail Sector

The purpose of this study is to assess the feasibility and impact of introducing subsidized malaria rapid diagnostic tests (RDTs) into retail sector drug shops in Uganda. This is a randomized controlled trial at the village level, taking place in 6 districts in Eastern Uganda. Licensed drug shops in selected villages were trained in proper RDT storage, administration, interpretation and disposal and were given access to subsidized RDTs for sale. This study explores whether drug shop owners--when given access to training and subsidized RDTs--will choose to promote and sell RDTs to customers and, if so, at what volume and what price. The investigators also explore whether shops will safely store, administer, interpret and dispose of RDTs and to what extent they will use RDT results to guide treatment recommendations. Finally, the study explores whether making RDTs available for sale in local drug shops has a community level impact on diagnostic testing and appropriate treatment for malaria.


Eligibility Criteria:
Inclusion Criteria:

Drug Shops:

* Licensed and registered as a Drug Shop with the Ugandan National Drug Authority

Households:

* Live in the village of participating drug shop
* Female household head is 18 or over

Exclusion Criteria:

Drug Shops:

* Drug Shop not registered with Ugandan National Drug Authority
* Female household head is under 18
Acupuncture for the Treatment of Rheumatoid Arthritis

To study the efficacy of acupuncture used as an adjunct measure for patients with refractory RA

The study employs a randomized, prospective, double-blind, placebo-controlled trial to evaluate the effect of electroacupuncture, traditional Chinese acupuncture and sham acupuncture in patients with refractory RA. All patients received 20 sessions over a period of 10 weeks. Six acupuncture points were chosen. Primary outcome is the changes in the pain score. Secondary outcomes included the changes in the ACR core disease measures, DAS 28 score and the number of patients who achieved ACR 20 at week 10.

Eligibility Criteria:
Inclusion Criteria:

* Fulfilled The American College of Rheumatology (ACR)\[10\] criteria of RA
* Active disease affecting the hands and wrists defined as having at least 4 tender joints and 2 swollen joints
* Early morning stiffness of greater than 45 minutes
* ESR \> 28 mmHg or CRP \> 10
* Patients taking disease modifying anti-rheumatic drugs (DMARDs) were eligible if they were on a stable dose for at least 3 months before screening.
* Patients on stable doses of one non-steroidal anti-inflammatory drug (NSAID) or up to 10 mg daily prednisone were also included.

Exclusion Criteria:

* Under the age of 18 years
* Pregnancy
* Previously had acupuncture
* Localized skin infections
* Anticoagulated
* Bleeding diathesis
* Intra-articular corticosteroid within 4 weeks preceding the study
* Any severe chronic or uncontrolled co-morbid disease
* Fear of needles
Genetic Analysis of Patients With Pseudoxanthoma Elasticum

This study will characterize the gene mutations responsible for pseudoxanthoma elasticum (PXE) and correlate them with disease manifestations in males and females. PXE is an inherited disorder that affects the connective tissue in some parts of the body. Calcium and other minerals are deposited in the connective tissue, causing changes in the skin, eyes, cardiovascular system and gastrointestinal system. Some effects of PXE can cause serious medical problems, while others have less impact. Symptoms often appear earlier and are more severe in females than in males, but there is no way to predict how the disorder will progress in any given individual.

Candidates for this study are recruited through PXE International, an organization that provides patient support and supports research on the disease. The organization collects biological samples and medical information on patients and family members to help further research on the disease. Families that have samples from the patient, both parents, and at least one sibling may be eligible for this study. Grandparents and extended family members may be included in certain instances.

Participants provide a blood sample, a sample of cells scraped from the inside of the cheek (buccal cells) and a medical history. The samples are analyzed for gene variants and the findings are correlated with disease signs and symptoms.

...

Background:

* Pseudoxanthoma elasticum (PXE) is an autosomal recessive genetic disorder characterized by mutations in the ATP-binding cassette transporter, ABCC6.
* PXE while it is known that patients have two mutated alleles of the ABCC6 gene, significant questions remain about the segregation of the disease, the presentation in males versus females and the correlation of mutation to clinical phenotype.

Objectives:

- The objective is to examine the role of variants in the ABCC6 gene in PXE.

Eligibility:

* Samples from study participants were obtained through the PXE International BioBank.
* Families were selected that have samples from both parents and at least one sibling in addition to the proband.

Design:

- Participants DNA was sequenced to identify variants and genotyped for linked markers to follow the segregation of mutant alleles and compare the results with the clinical outcomes.

Eligibility Criteria:
* INCLUSION/EXCLUSION CRITERIA:

A representative set of collected families will be studied. No subjects within these families will be excluded.

Families will be selected that have samples from both parents and at least one sibling in addition to the proband.

The siblings will include both affected and unaffected.

If grandparents are available they will also be typed to help in phase determination.

Extended relatives will only be selected in multiple generation families.
A Gene Transfer Single Dose Study to Evaluate the Safety, Tolerability and Efficacy of SRP-9003 in Non-Ambulatory and Ambulatory Participants With Limb Girdle Muscular Dystrophy, Type 2E/R4 (Beta-Sarcoglycan [β-SG] Deficiency)

The primary purpose of this study is to evaluate the safety of SRP-9003 and to quantify expression of β-SG in the skeletal muscle of participants with limb-girdle muscular dystrophy, type 2E/R4 (LGMD2E/R4). The study will include both ambulatory (Cohort 1) and non-ambulatory (Cohort 2) participants.


Eligibility Criteria:
Inclusion Criteria:

* Cohort 1 only: Ambulatory per protocol specified criteria. - Cohort 2 only: Non-ambulatory per protocol specified criteria and 4 to 50 years of age.
* Possesses 1 homozygous or 2 heterozygous pathogenic and/or likely pathogenic β-sarcoglycan gene Deoxyribonucleic acid (DNA) (SGCB) gene mutations based on documented clinical findings.
* Ability to cooperate with muscle testing.

Exclusion Criteria:

* Presence of any other clinically significant illness or medical condition, including cardiac, pulmonary, hepatic, renal, hematologic, immunologic, neuromuscular (other than LGMD2E/R4), or behavioral disease, or infection or malignancy or concomitant illness or requirement for chronic drug treatment that in the opinion of the Investigator creates unnecessary risks for gene transfer or a medical condition or extenuating circumstance that, in the opinion of the Investigator, might compromise the participant's ability to comply with the protocol required testing or procedures or compromise the participant's wellbeing, safety, or clinical interpretability.
* Exposure to gene therapy, investigational medication, or other protocol-specified treatment within the protocol specified time limits.
* Any contraindication to use of corticosteroid.

Note: Other inclusion or exclusion criteria could apply.
A Drug-Drug Interaction (DDI) Study of HDM1002 With Rifampicin and Itraconazole in Healthy Subjects

The purpose of this study is to characterize the effect of rifampicin and itraconazole on the PK of single dose of HDM1002 in healthy adult subjects. The safety and tolerability of HDM1002 and rifampicin or itraconazole when given separately or together will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

1. According to the medical history, clinical laboratory test results, vital sign measurements, 12 lead ECG results, and physical examination results during the screening period, the investigator considers the subject to be in good general health.
2. Age range of 18-45 years old (including range), no limit to gender.
3. Eligible male participant weighed ≥50.0 kg, eligible female participant weighed ≥45.0 kg, and had a body mass index (BMI) within the range of 19.0 - 32.0 kg/m2 (including cut-off values).

Exclusion Criteria:

1. Participant has a history or family history of medullary thyroid cancer, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2), or calcitonin≥50 ng/L during the screening period.
2. History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening.
3. History of acute cholecystitis within 3 month prior to initiation of screening period.
4. Participant judged by investigator has dysphagia, diseases or conditions that affect gastric emptying, or affect the absorption of gastrointestinal nutrients, such as bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, etc.
5. History of previous surgery that will affect the absorption, distribution, metabolism, and excretion of drugs or plan to undergo surgery during the study period.
6. During screening period, any abnormalities in physical examination, electrocardiogram, laboratory tests, and vital signs which are of clinically significant .
7. Taken or planned to take any drug that effect liver enzyme or transporter activity within 28 days prior to taking the investigational drug.
8. History of clinically significant cardiovascular and cerebrovascular disease within 6 months prior to screening or at the time of admission.
9. Presence of clinically significant ECG results judged by the investigator at screening.
Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis

This is a multi-center, prospective, controlled study. MS patients (1° group: 30 patients in relapse; 2° group: 30 patients in remission) and age/sex-matched healthy controls (3° group: 30 subjects) will be enrolled in the study. Patients' disability level will be evaluated by EDSS and MSFC.

Patients and controls will be tested for either coagulation/complement (C3, C4, C4a, C9, fibrinogen, factor VIII and X, D-dimer, protein C, protein S, antithrombin, factor II, aPTT, von-Willebrand factor), soluble markers of endothelial damage (thrombomodulin, Endothelial Protein C Receptor), antiphospholipid antibodies, lupus anticoagulant, complete blood count, viral serological assays or microRNA microarray.

Patients will undergo dynamic susceptibility contrast-enhanced MRI using a 3.0-T scanner to evaluate CBF, CBV, MTT, lesion number and volume.


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with relapsing-remitting multiple sclerosis, untreated or treated with only immunomodulatory therapy, in relapse o in remission

Exclusion Criteria:

* pregnant, with any neoplastic, hematologic, thyroid, metabolic, thrombotic or autoimmune disease, drug or alcohol addicted, treated with immunosuppressive drugs, steroids o any medication interfering with coagulation.
Diagnostic Performance of Contrast-Enhanced Mammography

Contrast-Enhanced Mammography (CEM) is a functional breast imaging technology. Like magnetic resonance imaging (MRI), CEM neovascularization enhancement can improve cancer detection rates, while lack of enhancement may lead to benign determination. The advantages of CEM are dramatically apparent in women with dense breasts. The purpose of this study was to investigate the additional diagnostic value of CEM added to the standard practice of mammography plus ultrasonography(US) in patients with suspicious breast lesions.

This study was a single-center prospective-retrospective combined observational study. In the prospective part, women with suspected breast abnormalities undergo prospective CEM evaluation, including acquisition of low energy (LE) images and recombined images (RI) showing enhancement, concurrently with breast US. The retrospective part selected the mammography and breast US data of female patients with suspected breast abnormalities who had previous baseline matching.


Eligibility Criteria:
Inclusion Criteria:

* Breast ultrasound or/and general mammography suggest that the lesion is BI-RADS 4 or above;
* Willing to undergo enhanced mammography examination;
* Agree to perform tumor core needle biopsy or excisional biopsy to confirm pathological diagnosis when necessary.

Exclusion Criteria:

* Allergy to iodinated contrast;
* Pregnant and lactating women;
* Suffering from kidney disease or abnormal kidney function, or undergoing renal dialysis;
* The breast is too large to be completely included in the full-field mammography examination at one time; ○5 Those with breast implants.
Incidence of Chronic Pain After Thoracic Surgery

Thoracotomy and video-assisted thoracic surgery procedures are frequently performed in thoracic surgery. It is widely accepted that thoracotomy causes severe acute pain. This prolongs the discharge time of the patients, and increases the frequency of postoperative pulmonary complications and postoperative morbidity. Postoperative acute pain may cause chronic thoracotomy pain in the later period, and may adversely affect the quality of life of the patients. Video-assisted thoracic surgery (VATS) has become the standard procedure in minor and major lung surgeries. Postoperative pain is seen in patients undergoing VATS, although it is not as severe as after thoracotomy. As in thoracotomy, this affects the postoperative pulmonary complications and the discharge time of the patients. Likewise, this pain can cause chronic pain.

In this study, it was aimed to analyze the symptoms of chronic pain in the 3rd and 6th months postoperatively in patients who had undergone thoracic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years
* American Society of Anesthesiologists physical status I-II-III
* Body mass index between 18-35 kg/m2
* Patients undergoing elective thoracic surgery

Exclusion Criteria:

* Advanced cancer
* History of chronic analgesic therapy
* Patients with previous thoracic surgery
* Patients who were operated under emergency conditions
Rapid Prototyping Models for Patient Education

Pre-made rapid prototyping models will be used to increase patient education versus current methodologies.

Post-partum women and their co-parent will have a medical condition explained to them first verbally, followed by a questionnaire, and then with the use of anatomical models created by rapid prototyping, followed by a questionnaire. The two questionnaires will then be compared.

Eligibility Criteria:
Inclusion Criteria:

* Mother
* Post-partum
* Atraumatic delivery of healthy, live infant at HMC
* Age \> 18

Co-parent

* Co-parent
* Atraumatic delivery of healthy, live infant at HMC
* Age \> 18

Exclusion Criteria:

* any pregnancy related issues
* fetal loss
* NICU stay \> 6 hours
* Emergent cesarean section
* Post-partum hemorrhage
* Hysterectomy
* Any other condition requiring unplanned, medical intervention during labor and delivery
* Prior fetal loss or anomaly
* Inability to read or write English
* those who do not consent
Study Protocol for Rosiglitazone Versus Gliclazide in Diabetics With Angina

The principle objective of the trial is to compare rosiglitazone to gliclazide in patients with type 2 diabetes mellitus and chronic stable angina to see how the subjects' angina status changes.

Angina status will be measured via exercise tolerance testing, 24-hour ECG testing and angina quality of life questionnaire.

Ischaemic heart disease is one of the main complications of type 2 diabetes mellitus, both in terms of morbidity and mortality. Reducing plasma glucose with hypoglycaemic agents has not been shown to improve cardiovascular mortality or morbidity. Chronic stable angina is a common problem in patients with type 2 diabetes mellitus.

We postulate that in subjects with uncontrolled type 2 diabetes mellitus (Hba1c \>7.5%), on metformin therapy, and chronic stable angina that the addition of the insulin sensitiser, rosiglitazone to control their diabetes will improve their angina when compared to the addition of the hypoglycaemic agent gliclazide. This hypothesis is based on the fact that insulin resistance is an upstream mechanism common to both conditions.

We will randomise such patients to 3 months therapy of rosiglitazone or gliclazide for 3 months, comparing angina status before and after by way of full Bruce protocol exercise testing, 24 hour ST segment analysis and angina questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Chronic stable angina with ongoing symptoms. (The treatment goal being an improvement in symptoms)
* Participants will have uncontrolled diabetes (Hba1c\>7.5) on metformin monotherapy (so the diabetes is not over treated)
* Participants will be diabetic for less than 8 years.

Exclusion Criteria:

* Renal impairment (creatinine \>130mmol/l)
* Hepatic Impairment (ALT\>70U/l, AST\>80U/l)
* Any clinical signs of heart failure
* Physical disability precluding treadmill exercise tolerance testing
* Abnormal resting ECG (left or right bundle-branch block, left or right ventricular hypertrophy, ventricular preexcitation, Q-wave myocardial infarction, digitalis therapy)
* Women of childbearing potential
* Women who are breastfeeding
Identification of Multiple Pulmonary Diseases Using Volatile Organic Compounds Biomarkers in Human Exhaled Breath

The goal of this observational study is to develop an advanced expiratory algorithm model utilizing exhaled breath volatile organic compound (VOC) marker molecules. This model aims to accurately diagnose mutiple pulmonary diseases. The primary objectives it strives to accomplish are:

1. To assess the diagnostic accuracy of an exhaled breath VOC-assisted diagnostic artificial intelligence (AI) model in diagnose several common pulmonary diseases.
2. To assess the diagnostic accuracy of an exhaled breath VOC-assisted diagnostic artificial intelligence (AI) model in diagnose more pulmonary diseases.

This is a prospective, cross-sectional, observational cohort study aimed at recruiting 10,000 participants with multiple pulmonary disease, including lung cancer, lung infection, chronic obstructive pulmonary disease (COPD), bronchitis, pulmonary fibrosis, pulmonary embolism, pulmonary arterial hypertension, tuberculosis, lung abscess, emphysema, radioactive lung injury, cystic fibrosis of the lung, Bronchial Asthma, Bronchiectasis, interstitial lung disease (ILD), preserved ratio impaired spirometry (PRISm) etc . Exhaled breath samples from these participants will be collected and analyzed using Gas chromatography-mass spectrometry(GC-MS) and micro Gas Chromatography-photoionisation detector (μGC-PID) system. Upon obtaining the μGC-PID results, a comprehensive evaluation of the diagnostic capabilities of exhaled breath samples in differentiating various pulmonary diseases will be performed, leveraging clinical diagnostic results, CT examination data, and clinical data.

Eligibility Criteria:
Inclusion Criteria:

* Males or females, age must be 18 years old or above.
* Patients must meet the CT imaging diagnostic criteria for different lung diseases, and patients must be able to provide electronic versions of CT image data.
* Patients must have a clear clinical diagnosis.
* All participants must sign a written informed consent form.

Exclusion Criteria:

* Pregnant women.
* Individuals with a history of cancer other than lung disease.
* Individuals who have undergone organ transplants or non-autologous (allogeneic) bone marrow or stem cell transplants.
* Individuals with other severe organic diseases or mental illnesses.
* Individuals with metabolic diseases such as diabetes, hyperlipidemia, etc.
* Any other condition that researchers deem unsuitable for participation in this clinical trial.
The Longitudinal Study of Low Anterior Resection Syndrome in Patients with Newly Diagnosed Rectal Cancer.

The aims are to identify the trajectory of LAR Syndrome and explore the adaptation process and coping strategies of LAR Syndrome in patients newly diagnosed with rectal cancer. The participants will recruit from a CRC surgical outpatient department of a medical center in northern Taiwan.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with stage I to III rectal cancer.
2. Patients already know their condition.

4. Aged 20 years and older. 5. Consciously communicate in Mandarin or Taiwanese. 6. Agreed with the interview and had signed the permit.

Exclusion Criteria:

1. Patients with Stage IV rectal cancer.
2. Recurred rectal cancer.