cyrilzakka/clinical-trials huggingface dataset:
An Intervention Delivered by Text Message to Increase the Acceptability of Effective Contraception Among Young Women in Palestine

This randomised controlled trial will establish the effect a contraceptive intervention delivered by mobile phone text message on the acceptability of effective contraception in Palestine. Woman aged 18-24 will be randomised to receive 0-3 text messages a day for 4 months (intervention) or a monthly text message not about contraception (control). Participants will complete a questionnaire at baseline and 4 month follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-24 years
* Own a personal mobile phone
* Not using the pill, implant, injection, intrauterine device or patch
* Live in the West Bank

Exclusion Criteria:

* Cannot read Arabic
Effect of Statins on Lipid Levels Following the First Acute Coronary Event (MK-0000-204)

The current study is proposed to investigate the pattern of dyslipidemia and of lipid treatment practices in patients in India experiencing their first acute cardiovascular event and the extent of residual dyslipidemia after 12 weeks of treatment with statins. Dyslipidemia definitions are per the National Cholesterol Education Program - Adult Treatment Panel III (NCEP-ATP III).


Eligibility Criteria:
Inclusion Criteria:

* Currently admitted with a confirmed diagnosis of first acute coronary event (STEMI/NSTEMI/Unstable Angina)
* Access to medical records covering the entire study period, and availability of data required for the study
* Potential to collect blood sample within 24 hours of onset for symptoms
* Considered for initiation/maintenance/modification of statin therapy before discharge from hospital
* Willing to comply with the study requirements

Exclusion Criteria:

* Participating in a clinical trial or any type of other clinical study involving therapeutic intervention or otherwise failing to consent to interview
* Known inherited disorder of lipoprotein metabolism
* History of hypothyroidism, nephrotic syndrome, chronic alcoholism, Cushing syndrome
Intensive Adjuvant Therapy for TNBC with BRCA Gene Mutation

Evaluation of the efficacy and safety of different adjuvant intensification regimens in early-stage BRCA1/2 mutant triple-negative breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* ECOG score 0-1
* TNBC
* BRCA1/2 mutation
* No distant metastases assessed by imaging after surgical treatment
* Breast cancer that is non-pCR after neoadjuvant therapy, or postoperative pathology suggestive of ≥pT2, or ≥pN1
* Have completed postoperative adjuvant chemotherapy and/or radiotherapy
* No major organ dysfunction

Exclusion Criteria:

* Patients who are unable to take oral medication, or who refuse this medication regimen
* Already enrolled in another study, or less than or equal to 4 weeks from discontinuation of another medication
* Presence of severe dysfunction of vital organs
* Patients with other malignancies (with the exception of cured non-melanoma skin cancers, carcinoma in situ of the cervix and other tumours that have been cured for at least 5 years)
* Acute infectious disease or active chronic infectious disease
* History of uncontrolled epilepsy, central nervous system disease or mental disorder
Efficacy and Safety Evaluation of Acupoint Application in the Treatment of Knee Osteoarthritis Joint Pain

To evaluate the efficacy and safety of acupoint application of Traditional Chinese medicine in the treatment of KOA joint pain through a prospective, randomized, double-blind, placebo-controlled clinical study.


Eligibility Criteria:
Inclusion Criteria:

1. Western medicine diagnosed as knee osteoarthritis, clinical classification is primary, and conforms to the TCM syndrome of cold and wet obstruction;
2. Guidelines for the diagnosis and treatment of osteoarthritis 2018 criteria and Kellgren -Lawrence\<Ⅲ;
3. VAS pain score ≥40mm (select the limb with the most obvious pain symptom);
4. For patients taking nonsteroidal drugs or other disease-improving drugs (such as cartilage protectants), the dose has been stable for at least 4 weeks;
5. Signed informed consent.

Exclusion Criteria:

1. Patients who underwent intra-articular therapy within 3 months prior to the trial or required relevant surgical treatment within 1 year；
2. Glucocorticoid and joint cavity injection were used 4 weeks before treatment;
3. swelling and heat of knee joint;
4. other diseases causing knee pain; Such as acute joint injury, tuberculous arthritis, rheumatoid arthritis, rheumatoid arthritis, suppurative arthritis, osteomyelitis, psoriatic arthritis, gout, villi nodular synovitis.
5. History or evidence of any of the following diseases during the screening period: serious cardiovascular and cerebrovascular diseases, active or recurrent ulcer of digestive system or other diseases at risk of bleeding, other serious diseases of digestive system, combined with malignant tumor, serious or progressive diseases of blood system or other systems.
6. Patients with other mental diseases who are unable to cooperate or unwilling to cooperate.
7. Before screening, any of the laboratory test indicators met the following criteria: ALT and AST \> 1.5 times the upper limit of normal value, Cr \> 1.2 times the upper limit of normal value, and other clinically significant laboratory test abnormalities, which were determined by the investigator to be unsuitable for inclusion in the group.
8. allergic constitution or allergic to test drugs, excipients or similar ingredients.
9. Suspected or confirmed history of alcohol or drug abuse;
10. pregnant or lactating women or those who have planned pregnancy recently and do not want to use contraception;
11. Participants in other clinical trials within 3 months prior to enrollment;
12. The investigator considered that the patients should not participate in the clinical trial.Other requirements for inclusion are willingness to participate for the duration of the trial. All patients will receive verbal and written information about the trial and sign a consent form before inclusion. The researcher obtains written consent before inclusion and randomisation.
Efficacy of Aquamantys for Reducing Transfusions With Anterior Supine Intermuscular Approach Total Hip Arthroplasty

The purpose of this study is to establish whether or not there is a clinical advantage to the use of Aquamantys® System from Medtronic Advanced Energy (formerly Salient Surgical Technologies) in patients undergoing primary total hip arthroplasty via the anterior supine intermuscular surgical approach in terms of blood loss, transfusion and wound healing. Wound healing will be assessed by a blinded observer and based upon a simple and subjective criteria: a) as expected, b) better than expected or c) worse than expected. The blinded observer is experienced in the care of the surgical patient and wound evaluation.

To establish in a randomized, blinded study whether or not there is a clinical advantage to the use of Aquamantys® System from Medtronic Advanced Energy (formerly Salient Surgical Technologies) in patients undergoing primary total hip arthroplasty via the anterior supine intermuscular surgical approach in terms of blood loss, transfusion and wound healing based on early collected data. Data will be analyzed using StatsDirect in standard fashion to elucidate any difference between control and treatment groups. Wound healing will be assessed by a blinded observer and based upon a simple and subjective criteria: a) as expected, b) better than expected or c) worse than expected. The blinded observer is experienced in the care of the surgical patient and wound evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing primary unilateral total hip arthroplasty via the anterior supine intermuscular approach
* Patient is willing and able to complete all follow-up visits at 6 weeks and 1 year

Exclusion Criteria:

* Patients with pre-existing known coagulopathy
* Patients on chronic Coumadin (Warfarin) therapy
* Patients receiving erythropoietin therapy for anemia
Efficiency of the "medidux" Smartphone App for Demission Management in Patients Medicated in Acute Admission Unit (AAU)

The goal of this clinical trial is to evaluate whether the use of the medidux™ smartphone app can optimize post-discharge management for patients admitted to Acute Admission Units (AAU) with non-urgent health complaints. This trial includes adult patients (age ≥ 18) in Emergency Severity Index (ESI) triage system groups 4 (standard) or 5 (non-urgent), presenting with primary symptoms such as cough, back pain, or abdominal discomfort.

The main question it aims to answer is:

Can the medidux™ app reduce the incidence of AAU readmissions, emergency hospitalizations, or consultations with other medical providers within 7 days after initial admission?

Researchers will compare participants using the medidux™ app (intervention arm) with those receiving standard care (control arm) to observe potential differences in the rates of readmissions, emergency hospitalizations, and medical consultations.

Participants will:

* use the medidux™ app to monitor their symptoms and vital parameters for 7 days after discharge (intervention arm).
* receive follow-up consultations at day 7 and at day 28 to assess symptom progression and any healthcare interactions (both arms).


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form (ICF)
* Age ≥ 18 years
* (Self-)admission to the involved Acute Admissions Unit (AAU)
* "Lead symptom" identified as coughing, back pain or abdominal discomfort
* Participant within ESI triage system group 4 (standard) and 5 (non-urgent)
* German-speaking
* Ownership of a smartphone or other mobile device with iOS or Android operating system

Exclusion Criteria:

* Age \< 18 years
* Participant whose compliance to the study's protocol, e.g. due to mental health problems, physical problems, or the private life situation, can be justifiably doubted
* Participant with insufficient knowledge about the use of a smartphone or other mobile device with iOS or Android operating system
* Participant already using or planning to use another comparable electronic patient-reported symptom monitoring system (e.g. CANKADO) during this trial
Assessing the Clinical Benefits of a Pharmacogenetics-Guided Dosing Regiment for Calculating Warfarin Maintenance Dose

Interethnic differences in warfarin dose requirements in the Asian population have been well described. Our previous studies showed that warfarin maintenance doses in our multi-ethnic population were closely related to patient demographics and genetic polymorphisms in cytochrome(CYP)P4502C9 and vitamin K epoxide reductase complex subunit 1(VKORC1). A retrospective regression model combining these predictors accounts for 57.8% of the variability in warfarin dose.

Hypothesis: We hypothesize that warfarin dose requirement could be more accurately predicted using a simplified genotyping procedure requiring the identification of a single CYP2C9 allele and a single nucleotide polymorphism of VKORC1 to discern between the 2 major haplotypes H1 and H7.

Aims: The aim is to compare the clinical benefits of genetics-guided dosing versus traditional trial and error dosing with protocol guided-adjustments. Two secondary objectives are (1) to prospectively evaluate a dosing algorithm built on demographics and genetic predictors; (2) to assess the feasibility of a simplified test for CYP2C9\*3 and VKORC1 SNP in clinical practice.

Methodology: A randomized controlled trial targeted at accruing 100 patients with indication for wafarin therapy. The endpoint for comparing genetics-guided dosing against traditional dosing method at the anticoagulant clinic is the number of dosage titrations to achieve targeted International Normalized Ratio (INR) at 1, 2 and 3 months of initializing warfarin. Upon reaching steady-state, pharmacokinetics of warfarin R- and S-isomers will be assessed for correlation with dose requirements based. An assay for easy identification of genetic polymorphisms required in this dosing regimen in a clinic setting will also be validated.

Significance: This concerted, multi-disciplinary effort to bring pharmacogenetics-based therapy from bench to bedside has the potential to reduce the efforts incurred with multiple dose titrations of the most commonly prescribed oral anticoagulant. With the aid of mathematical modeling, a simplified and more cost-effective genotyping method could be implementation for the future treatment and prophylaxis of thromboembolic diseases.

Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age
2. New indication for warfarin therapy
3. No previous history of liver disease; transaminases must be less than 3 times upper limit of normal and bilirubin within normal range
4. No previous history of malabsorption syndrome or chronic diarrheal conditions
5. Written, informed consent

Exclusion Criteria:

1. Uncontrolled hypertension
2. Peptic ulcer disease
3. Any other medical conditions as deemed unfit for warfarin therapy based on clinical judgement of primary physician
Investigating the Brain's Physiological Responses in Depression and Autism, Using Transcranial Magnetic Stimulation and Electroencephalography

The goal of this observational study is to investigate the brain physiological responses in depression and autism. The main questions aim to answer are:

1. Comparing the ratios of cortical excitation and inhibition among four groups: autism group, autism with depression group, depression group, and normal control group using Transcranial magnetic stimulation and electroencephalography (TMS-EEG). This study explores the relationship between the ratios of cortical excitation and inhibition and the severity of clinical symptoms.
2. Comparing the brain inflammation among four groups: autism group, autism with depression group, depression group, and normal control group using Positron emission tomography (PET). This study investigates the relationship between brain inflammation and the severity of clinical symptoms.
3. The mutual influence between the severity of brain inflammation and Excitatory/inhibitory imbalance (E/I imbalance).

Participants will receive clinical assessment, neurocognitive function tests, TMS-EEG, gamma oscillation, and PET examinations.


Eligibility Criteria:
Inclusion Criteria:

* Autism group : Adults aged 20-50 diagnosed with autism spectrum disorder。Intelligence Quotient(IQ) \> 70, with autonomous abilities.
* Autism group with comorbid depression : Adults aged 20-50 diagnosed with autism spectrum disorder. Diagnosed with depression. IQ \> 70. Not on antidepressants for at least one week, with autonomous abilities.
* Major depression disorder group : Adults aged 20-50. Diagnosed with major depressive disorder according to Diagnostic and Statistical Manual of Mental Disorders-IV-TR(DSM-IV-TR). IQ \> 70. Not on antidepressants for at least one week, with autonomous abilities.
* Typically developing control group : Adults aged 20-50. Never diagnosed with autism spectrum disorder. Never diagnosed with depression. IQ \> 70, with autonomous abilities.

Exclusion Criteria:

* Previously diagnosed with bipolar disorder, schizophrenia, attention deficit hyperactivity disorder (ADHD), or substance use disorder according to DSM-IV.
* Previously suffered from major medical or neurological diseases.
* Brain structural abnormalities (e.g., brain tumor or arteriovenous malformations) or neurological diseases (e.g., meningitis, encephalitis, stroke, or epilepsy).
* Previously undergone or soon to undergo brain surgery, or have metal implants in the head or neck area, such as neuro-stimulators or cochlear implants.
* Have a cardiac pacemaker.
* Pregnant participants.
* Participants with strong suicidal intentions.
* Other conditions that render the patient unable to cooperate, such as unsuitability after screening, unstable physical illness, or refusal to sign the informed consent.
* Claustrophobia, unable to undergo positron emission tomography(PET) and functional magnetic resonance imaging (fMRI) scans.
* Taking medications that may affect Excitatory/inhibitory balance (E/I balance).
Enhancing Strength Gains With the Power of the Mind

The goal of this clinical trial is to determine the effect of maximal mental effort combined with elastic band training on strength and neuromuscular function in healthy, older females. The main questions it aims to answer are:

* Does elastic band training in combination with maximal mental effort increase strength more than elastic band training alone?
* Does elastic band training in combination with maximal mental effort improve neuromuscular function more than elastic band training alone?

Participants will be randomly assigned to 1 of 3 groups:

* Elastic band training
* Elastic band training with maximal mental effort
* Control

Researchers will compare groups to determine differences in changes in strength, neuromuscular function, and body composition.

Participants in both training groups will perform 6 weeks of moderate intensity, whole-body elastic band training. Participants in the control group will participate in all testing procedures but not perform any training. Participants from both groups will be instructed to maintain their normal physical activity levels and dietary habits.

All training sessions will be home-based and virtually supervised by research personnel. Participants will complete 2 training sessions in the first week and 3 training sessions per week for the remaining 5 weeks. Each training session will last about 45-60 minutes and consist of 7 exercises performed in the same order by each participant, including both multi-joint (chair squat, chest press, leg press, back row) and single-joint (knee extension, knee flexion, elbow flexion) exercises. Participants will perform 12 repetitions for each exercise for the first 3 weeks, then volume will be increased by progressing to 4 sets for the remaining 3 weeks. There will be a 60-second rest interval between sets and a similar tempo will be used between groups.

Both training groups will perform the same training protocol, but participants in the maximal mental effort group will mentally urge their muscles to contract maximally during each repetition. That is, despite using a moderate intensity, participants will imagine the feeling of maximal muscle contraction of the primary muscles during each repetition.

Several measures of strength, neuromuscular function, physical function, and body composition will be measured before and after the training or control period.

Eligibility Criteria:
Inclusion Criteria:

* Between 65-79 years of age
* Female
* Have not engaged in structured exercise for 3 years
* Are not reliant upon a walking aid
* Be able to rise from a chair unassisted
* BMI between 25-33 kg/m²
* Have access to the internet and access to a smartphone or computer with a camera at home

Exclusion Criteria:

* Any history of cardiovascular, cerebrovascular, or metabolic diseases
* Musculoskeletal injury within the past 6 months
* Any condition affecting muscle function
* Uncontrolled hypertension
* Score less than 23 on the Mini-mental State Exam
* Upon starting study, missing more than 2 training session
The Role of Gut Leakage Markers and Microbiota Signature in Coronary Artery Disease.

Define a signature of gut microbiota composition and related metabolites in patients with ST-elevation myocardial infarction, non ST-elevation myocardial infarction and chronic coronary disease (CAD).

A total of 200 patients, allocated to 50 patients with chronic coronary syndrome, 75 patients with non-ST elevation myocardial infarction and 75 patients with ST- elevation myocardial infarction will be included. Clinical information, blood samples and fecal samples will be collected. Fecal and blood samples will be collected once in patients With chronic disease and in patients with acute coronary syndrome; in the acute phase and after 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Coronary heart disease verified by coronary angiography

Exclusion Criteria:

* Current infection requiring intravenous antibiotics
* Inflammatory bowel disease
* Renal failure with creatinine \> 200µmol/L
* Hepatic impairment
* Pregnancy
* Previous bariatric surgery
* Colostomy
* Active malignant disease
Image Quality and Radiation Dose Associated With Cardiac Scans in Modern CT Scanners

The main objective of this study is to evaluate the dose efficiency of coronary CT angiography (CTA) using a photon counting detector CT (PCD-CT) with the dose efficiency of coronary CT angiography of prior CT generations. 100 patients with a clinical indication for coronary CT angiography will be prospectively enrolled and undergo coronary CTA on a PCD-CT. For comparison, a matched retrospective cohort of 100 patients will be created who had undergone on a prior scanner generation (retrospective cohort).


Eligibility Criteria:
Inclusion Criteria:

* indication for coronary CTA confirmed by board-certified radiologist ('justified indication' according to German/European radiation protection law) AND
* patient (is able to give informed consent and) has given informed consent.

Exclusion Criteria:

* contraindications to (iodine based) iv contrast material: known allergy to iodine-based iv contrast, acute or high-grade chronic kidney insufficiency with an estimated glomerular filtration rate \< 30 ml/min/1.73 m², latent or manifest hyperthyroidism
* known or suspected pregnancy
* lactating mothers
DISCO: A Patient Intervention to Reduce the Financial Burden of Cancer

The DISCO App is designed to improve, during the interaction, patient active participation and patient-initiated oncologist treatment cost discussions, and, in the short term, patient's treatment cost knowledge, self-efficacy for managing both cost and physician interactions, referrals, perceived financial toxicity (i.e., distress and material hardship); in turn, these will affect longer-term outcomes of financial toxicity and adherence.

This work is based on the core scientific premise - that increasing patient active participation and the frequency and quality of treatment cost discussions will decrease the short- and longer-term burdens of financial toxicity through their influence on self-efficacy for managing treatment cost. The focus is on patient self-efficacy for managing treatment cost because it is expected that improved treatment cost education and patient-oncologist treatment cost discussions prompted by the DISCO App will directly improve the self-efficacy needed for patients to proactively manage treatment costs, thus reducing the material and psychological burden of financial toxicity. The DISCO App is not designed to increase patients' ability to pay or reduce the cost of treatment, but it may benefit patients by increasing: their knowledge of treatment costs, their self-efficacy for managing cost, and the likelihood they receive financial and psychological assistance and support. This research is significant because, if successful, reducing the material and psychological burden of financial toxicity will improve the quality of care and work toward achieving health equity. The DISCO App has already been tested for its feasibility and acceptability. The DISCO App will now be tested for its effectiveness in a diverse population of people with solid tumors treated with IV and oral chemotherapies.

Eligibility Criteria:
Inclusion Criteria:

* Oncologists are eligible if they treat patients with breast, prostate, lung, or colorectal cancers at Karmanos Cancer Institute. Data from oncologists will include their self-report data and video-recorded treatment discussions with participating patients.
* Patients: Must be able to read and write in English; have an email account; and are newly diagnosed with breast, prostate, lung or colorectal cancer (stage I-IV) for which systemic therapy is a likely recommended treatment. Data from patients will include their self-report data, video-recorded treatment discussions with participating oncologists, and medical record data

Exclusion Criteria:

-