cyrilzakka/clinical-trials huggingface dataset:
Home PT vs FORCE PT

The purpose of this study is to determine if unsupervised, home rehabilitation delivered by a web-based platform or paper manual is a safe and effective alternative to outpatient physical therapy after total knee replacement.


Eligibility Criteria:
Inclusion Criteria:

1. Any patient undergoing unilateral, primary TKA

Exclusion Criteria:

1. Patients without access to the Internet
2. Patients without access to outpatient PT
3. Revision or conversion TKA
4. Patients discharged to a rehabilitation unit or other form of respite care such as a skilled nursing facility, acute rehabilitation center, convalescent home, long-term care facility or nursing home.
Neuromodulation With Transcranial Direct Current Stimulation (tDCS) to Control Excess Weight

The purpose of this study is to examine the effects of noninvasive neuromodulation with transcranial direct current stimulation (tDCS) aimed at enhancing the excitability of the left prefrontal cortex in middle-aged women with excess body weight. This is a randomized, parallel, double-blind study with a duration of 4 weeks. Outcome measures will include changes in performance in a computerized task assessing executive functions, subjective measures of food craving and appetite and changes in body weight.

A total of 40 subjects with overweight or class I obesity will be enrolled and randomized into either Group 1) Active tDCS or Group 2) Sham (control) tDCS. The duration of the study will be 4 weeks. During the first two weeks participants will receive eight sessions of tDCS. At week 2 they will also start a hypocaloric diet. The stimulation sessions (duration: 20 minutes, intensity: 2 mA) will be applied once daily (5 days in a row) during the first week and 3 alternate days (Monday, Wednesday and Friday) during the second week. At week 2 and until the end of the study subjects will also start a hypocaloric diet.

The study aims are:

1. To examine whether anodal tDCS applied over the left prefrontal cortex can improve executive functions/inhibitory control and reduce subjective ratings of food craving and appetite.
2. To study whether anodal tDCS applied over the left prefrontal cortex, in combination with a hypocaloric diet, can facilitate weight reduction and maintenance over time.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 25 and 35 kg/m2

Exclusion Criteria:

* Endocrinology disorder, such as diabetes mellitus or thyroid disease
* Addiction
* Neurological, psychiatric or any other major medical condition
* Hormonal therapy
* Contraindications to receive tDCS (past history of seizures or epilepsy, metallic implants on the head, skin disease or lesions in the area to be stimulated).
Risk of Acute Liver Injury in Users of Antimicrobials

Moxifloxacin is a broad-spectrum antibacterial agent used to treat common community-acquired respiratory tract infections, complicated intra-abdominal infections, and pelvic inflammatory disease. In the clinical development program, moxifloxacin was associated with some hepatic adverse drug reactions. To evaluate further the hepatic safety profile of moxifloxacin, a retrospective cohort study with nested case-control analysis will be conducted to assess the rate of noninfectious acute liver injury among new users of moxifloxacin and of other antimicrobials prescribed for similar indications, including amoxicillin, amoxicillin plus clavulanic acid, cefuroxime, clarithromycin, doxycycline, levofloxacin, and telithromycin.

The study will be implemented in the population included in the HealthCore Integrated Research Database (HIRD). Eligible patients are adults aged 18 years and older with continuous enrollment in the HIRD for at least 6 months before their first claim for a prescription for a study antimicrobial. Follow-up will start at the date of the first prescription until the date of the earliest of the following events: noninfectious acute liver injury, occurrence of an exclusion criterion, end of study period, disenrollment from database, or death. Patients with chronic alcoholism or cirrhosis, infectious hepatitis, HIV/AIDS, or pregnant women will not be included.

Study design is called 'Cohort study with nested case-control analysis"

Eligibility Criteria:
Inclusion Criteria:

* All persons meeting the following criteria during the study period (July 1, 2001, through March 31, 2009) are eligible for study inclusion:
* First insurance claim for a dispensing of one of the study antimicrobials during the study period ("new users")
* Aged 18 years old or older
* Continuous enrollment in the study database for at least 6 months prior to start of follow-up (which is the date of the first claim for any of the study antimicrobials)
* Patient data defined as acceptable for research purposes according to the quality criteria of the HIRD

Exclusion Criteria:

* Pregnant women
* Patients with chronic alcoholism or cirrhosis
* Patients with history of acute and/or chronic infectious hepatitis or HIV/AIDS
Inflammatory Cell Trafficking After Myocardial Infarction

Myocardial infarction (heart attack) is usually the consequence of rupture of a fatty 'plaque' in a heart artery. The presence of this fat and debris causes the propagation of a blood clot and blockage of the artery. The heart muscle normally supplied by the artery becomes deprived of oxygen and, if starved for long enough, this area of muscle dies. Much of the heart muscle damage is caused by overactivation of inflammatory cells. Whilst inflammation can be beneficial in healing processes, there is accumulating evidence that overactivation of inflammatory processes contributes to further muscle damage and cell death during myocardial infarction. We have recently developed a means of labelling human blood cells with 'nanoparticles' of iron oxide which can then safely be reinjected into the blood to allow the cells to be tracked and seen in the body using a conventional magnetic resonance scanner.

In the proposed study we aim to recruit patients with recent heart attacks to perform similar cell labelling and reinjection of labelled cells into the same volunteer's blood stream via the arm to track the fate of the blood cells over the course of days to months. We think that the labelled inflammatory cells will 'home' to the site of the heart attack and will be visible using magnetic resonance imaging (MRI) of the heart. We aim not only to highlight the role of inflammatory cells in myocardial infarction, but also propose that, if successful, this technique could be used in the future to assess the effects of antiinflammatory treatments currently being developed for the treatment of patients with heart attacks. The technique could also be extended to allow labelling of other cell types, including stem cells, to let us further understand how these cells may contribute to repair of damaged organs including the heart.


Eligibility Criteria:
Inclusion Criteria:

* Presentation with acute ST segment elevation myocardial infarction:

  * 1 mm ST elevation in at least two contiguous limb leads, or
  * 2 mm ST elevation in at least two contiguous praecordial leads, or new onset bundle branch block
* Successful treatment with primary percutaneous coronary intervention Restoration of TIMI grade 3 flow in infarct-related artery
* Troponin I ≥10 IU/mL at 12 hours after the onset of chest pain
* Age 18 - 80 years

Exclusion Criteria:

* Left main stem or severe multi-vessel coronary artery disease
* Continued symptoms of angina at rest or minimal exertion
* Atrial fibrillation
* Symptomatic heart failure; Killip Class ≥2.
* Hepatic or renal failure (estimated glomerular filtration rate \<25 mL/min)
* Terminal illness or malignancy
* Anaemia
* Contraindication to magnetic resonance imaging
* Hepatitis B, hepatitis C, HTLV, HIV or syphilis infection
* Patients at risk of allergy to protamine (fish allergy, infertile men, previous vasectomy)
Efficacy of Magnetotherapy in Hand Erosive Osteoarthritis.

Erosive arthritis (EA) is an unusual pathology. There is no definitive treatment and the conventional one has little efficacy. Despite using magnetotherapy (MGT) as a treatment, there is no evidence supporting its use.

The aim of the study is to evaluate the efficacy of MGT in patients suffering from hand EA, compared to placebo, in terms of pain (assessed by Visual Analog Scale (VAS)) and functionality (assessed by The Disabilities of the Arm, Shoulder and Hand (DASH) score) during the treatment and after a 3-months period. Secondarily, rigidity (Modified Kapandji Index), grip strength (JAMAR dynamometry) and quality of life (SF-36 questionnaire) were assessed. Treatment safety will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes older than 18 years with symptomatic hand erosive osteoarthritis for more than 6 months.
* Patients receiving treatment or not for their hand pathology.
* Patients suffering from hand chronic pain due to their pathology and scoring VAS equal or greater than 4/10.
* Patients who voluntarily signed the informed consent and agree to participate in the study.

Exclusion Criteria:

* Pregnancy
* Patients with pacemaker or similar devices
* Pacients with cognitive dysfunction.
* Patients with psychiatric pathologies unable to comply with the treatment and follow-up
* Patients with active oncological and / or infectious pathology
* Patients with previous magnetotherapy or paraffin treatment in the last year
Topotecan Plus Apatinib Versus Topotecan Alone as Second-line Therapy in Small-cell Lung Cancer

The purpose of this study is to determine whether topotecan plus apatinib are superior to topotecan alone as second-line therapy in small-cell lung cancer.

Small-cell lung cancer (SCLC) is an aggressive tumor and most patients experienced relapse or progression after standard chemotherapy. Topotecan is active as second-line therapy for SCLC patients. However, even in sensitive patients, only 20% response rate and a median time to progression of 12 weeks are observed. New therapeutic options in SCLC are needed. Apatinib is a small-molecule tyrosine kinase inhibitor that inhibits vascular endothelial growth factor receptor 2. It has been approved in patients with advanced gastric cancer refractory to two or more lines of prior chemotherapy. The efficacy of apatinib in SCLC is unknown. The purpose of this study is to determine whether topotecan plus apatinib are superior to topotecan alone as second-line therapy in small-cell lung cancer.

Eligibility Criteria:
Inclusion Criteria:

* limited or extensive-stage SCLC who had failed to first-line therapy
* ≥18 years old
* Eastern Cooperative Oncology Group performance status ≤2
* at least one measurable lesion as defined by RECIST (version 1.1)
* at least one measurable lung tumor lesion
* WBC count ≥3,500/μL, neutrophils ≥1,500μL, platelets ≥100,000μL, hemoglobin ≥ 9.0 g/dL
* AST, and ALT ≤2 × the upper limit of normal or ≤5 × the upper limit of normal with liver metastases.

Exclusion Criteria:

* symptomatic CNS metastases
* concomitant or previous malignancies within the last 5 years
* severe comorbidities; prior topotecan therapy
* hypersensitivity or other contraindication to the study drugs.
Artificial Intelligence-Assisted vs Surgeon-Directed Screw Planning in Robotic Femoral Neck Fracture Surgery

The goal of this clinical trial is to compare two different methods of screw path planning-AI-assisted versus surgeon-directed-in robotic-assisted femoral neck fracture fixation surgery. The study will include adult patients diagnosed with femoral neck fractures who are eligible for surgical fixation using a robotic system. The main questions it aims to answer are:

Does AI-assisted screw path planning improve the radiographic accuracy of screw placement? Does AI-assisted planning reduceoperative time, number of intraoperative fluoroscopy exposures, intraoperative blood loss (mL)? Does AI-assisted planning reduce postoperative complications and improve functional outcomes compared to surgeon-directed planning? Researchers will compare the AI-assisted planning group to the surgeon-directed planning group to determine whether AI guidance contributes to enhanced surgical precision, reduced operative risk, and improved recovery outcomes.

Participants will:

Undergo robotic-assisted internal fixation of femoral neck fractures with either AI-assisted or surgeon-directed screw path planning, Receive standardized perioperative care and follow-up at defined intervals, Be evaluated through clinical assessments, imaging studies, and documentation of intraoperative and postoperative metrics over a 6-month follow-up period.

Femoral neck fractures, occurring between the femoral head and neck base, are among the most common hip injuries, particularly in the elderly population. While surgical fixation with closed reduction and cannulated screws is a widely accepted standard, challenges such as suboptimal screw placement, prolonged fluoroscopy exposure, and increased risk of complications like nonunion or avascular necrosis persist-largely influenced by surgeon experience and intraoperative variability.

To address these limitations, this trial investigates the effectiveness and safety of artificial intelligence (AI)-assisted versus surgeon-directed screw path planning in robotic-assisted internal fixation of femoral neck fractures.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Radiologically confirmed diagnosis of femoral neck fracture (displaced or non-displaced);
* Scheduled to undergo robotic-assisted internal fixation with cannulated screws as the initial treatment strategy during the study period;
* Capable of understanding the study procedures and providing informed consent;
* Willing and able to adhere to the prescribed postoperative follow-up schedule and rehabilitation instructions.

Exclusion Criteria:

* Evidence of avascular necrosis of the femoral head on the affected side prior to surgery;
* Inability to tolerate the surgical intervention;
* Severe physical illnesses, cognitive problems (such as memory loss), or mental health conditions that may impair the ability to comply with medical instructions or attending scheduled follow-up appointments.
The Role of the FTO Gene in Reward System Activation in Obese and Healthy Subjects

In order to investigate if individuals, carrying genetic variants predisposing to obesity, respond differently to visual presented food images than non-carriers the investigators aim to screen 500 people for a common risk variant in the FTO gene. From those 500 screened 40 subjects, 20 homozygous for the risk allele and 20 homozygous for a non risk allele will be selected for the second step in the study. This part involves the fMRI technique to visualize the brain response, focus on reward system activation, when food images are visually presented in the scanner. Factors regarding eating behavior, sleep, physical exercise and relation to food are investigated in the first part of the study as well as clinical parameters such as BMI.


Eligibility Criteria:
Inclusion Criteria:

* No medications (except contraceptives including estrogen)
* No metabolic disorders/diseases
* Right handed
* Color vision
* Normal sleep-wake rhythm (eg. shift workers can not participate)

Exclusion Criteria:

* Specific preferences of food, for example vegetarians
* Grandparents originating from country outside the Nordic area
* Metallic implants
A Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Doravirine (MK-1439) (MK-1439-019)

This study aimed to investigate the influence of hepatic insufficiency on the pharmacokinetics (PK) of doravirine (MK-1439). In Part 1, PK of doravirine in participants with moderate hepatic insufficiency was compared with that of healthy control subjects matched with regard to mean age and weight. If a clinically meaningful increase in exposure of doravirine was observed in participants with moderate hepatic insufficiency in Part 1, study Part 2 was to evaluate PK of doravirine in participants with mild hepatic insufficiency.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) between 19 and 40 kg/m\^2
* Continuous non-smoker or moderate smoker of \<20 cigarettes or equivalent per day. Agrees to consume \<=10 cigarettes or equivalent per day from the time of screening through the period of sample collection.
* In good health and with no clinically significant electrocardiogram abnormality
* Hepatic impairment participants: diagnosis of chronic (\>6 months), stable hepatic insufficiency with features of cirrhosis due to any etiology. Part 1 only: score of 7 to 9 on the Child-Pugh scale. Part 2: score of 5 to 6 on the Child-Pugh scale.
* Females of childbearing potential: sexually inactive for \>=14 days before study drug administration and throughout the study, or using 2 acceptable methods of barrier contraception from screening until 14 days after study drug administration.

Exclusion Criteria:

* Mentally or legally incapacitated or has significant emotional problems at the time of screening or expected during the study
* History or presence of clinically significant medical or psychiatric condition or disease
* History or presence of drug abuse within the past 2 years
* History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds
* Female participant who is pregnant or lactating
* Positive results for breath alcohol or urine drug screen (unless due to prescription drug use and is approved by the investigator) at screening
* Positive for HIV at screening
* Unable to refrain from or anticipates the use of any drug known to be a significant inhibitor or inducer of cytochrome oxidase CYP3A or P-glycoprotein, or any medication or substance which cannot be discontinued at least 14 days before study drug administration and throughout the study.
* Donation of \>500 mL of blood or had significant blood loss within 56 days before study drug administration
* Plasma donation within 7 days before study drug administration
* Dosed in another clinical trial within 28 days before study drug administration
* Healthy control participants only: positive for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) at screening;
Facilitating Advance Care Planning Discussions for People With Advance Cancer

The aims of this study are to (1) identify the advance care planning deliberation process among 20 dyads of patients with advanced cancer and family caregivers and (2) conduct usability testing among 9 dyads to refine the content and design of the web-based resilience-building intervention.

Patients with advanced cancer have not fully benefited from advance care planning due to the high levels of anxiety and depression experienced and other barriers that affect their appraisals and coping. Despite the protective effects of resilience, there have been few clinical trials improving the resilience skills of patients with advanced cancer and their family caregivers to help initiate advance care planning discussions and sustain engagement. This research will provide new insights through using a dyadic intervention approach to advance care planning while developing and evaluating a web-based resilience-building intervention to improve the completion of advance directives, resilience, coping, anxiety, and depression for patients with advanced cancer and their family caregivers.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be eligible for the study if they (1) are ≥ 18 years of age; (2) have a cancer diagnosis; (3) are able to read and respond to questions in English with minimal assistance from family caregivers for interpretation; (4) have previously completed an advance directive such as a living will; (5) have a family caregiver who serves as a surrogate in the advance directive and is willing to participate in the study; and (6) have access to the internet on a cell phone, laptop, or computer.
* Family caregivers will be eligible if they (1) are ≥ 18 years of age; (2) are able to read and respond to questions in English with minimal assistance from others for interpretation; (3) are identified by the patient as a family caregiver who serves as a surrogate for health care decisions; and (4) have access to the internet on a cell phone, laptop, or computer.

Exclusion Criteria:

* Patients who have cognitive impairment per a Short Portable Mental Status Questionnaire score \< 8.
Raising Awareness of Online Therapies for Depression: Pilot Study

Web based cognitive behavioural therapy (webCBT) for depression is recommended by NICE but analysis of the geographic distribution of one webCBT site showed 15-fold variation in use across Britain. Such variation is unlikely to be from differences in prevalence. Raising awareness of webCBT could benefit many people with depression but it is not clear how direct-to-patient promotion online or via the media, compares with GP centred methods. This pilot cluster randomised controlled trial will explore the use of online methods to raise awareness in preparation for subsequent study comparing different approaches.

In a pilot cluster randomised trial the investigators will explore the feasibility and likely impact of online methods of raising awareness of webCBT, assessing how many people with depression respond to geographically restricted Google and local website advertisements. The investigators will explore costs of recruitment and define and document the best online methods that might subsequently be used in a definitive trial comparing online with mass media and GP centred methods for raising awareness. The investigators will compare intervention with control areas to estimate impact on registration levels and compare rate of completion of webCBT of these 'additional' registrants with other registrants. Recommendations will be made for a subsequent trial comparing online with other methods.


Eligibility Criteria:
Inclusion Criteria:

* people living in Britain searching for online help for depression

Exclusion Criteria: