cyrilzakka/clinical-trials huggingface dataset:
Successful Aging and Age-related Decline

Recent studies have shown promising cognitive and physical interventions aimed at slowing down ageing-related declines in quality of life, but they lack strong ecological validity (brief durations, unrealistic goals, no real-world application) and has yet to show robust evidence that such interventions are stable and suitable in the long-term. The investigators aim to examine whether these interventions can, over four years, significantly slow down the normal rate of ageing-related decline.

This is a longitudinal, controlled, cohort study. The overarching aim in this intervention study is three-fold: (1) to test hypotheses derived from ageing-related theories, (2) to provide robust measurable evidence both in the long-term and validate meaningful interventions, and (3) provide quantifiable cost-benefit ratio to suggested solutions. A cohort of Malaysian older adults will be recruited and assigned to one of the groups, either cognitive stimulation, physical activity, combined cognitive stimulation and physical activity, or non-intervention control.

Eligibility Criteria:
Malaysian older adults aged 60 and above who fulfil the following criteria will be recruited:

Inclusion Criteria:

* Healthy and this includes those seeking regular medical attention,
* Have some form of mobility (ability to walk short distances at least 3m),
* Able to communicate in at least one of the following languages: English, Malay, Mandarin, Tamil.

Exclusion Criteria:

* Older adults with a history of stroke,
* Diagnosis of neurodegenerative diseases (such as Alzheimer's disease or Parkinson's) or psychiatric disorders,
* Uncorrected auditory and/or visual impairments,
* Currently on psychiatric medications,
* Immobile,
* Require full-time caregiver assistance,
* With comprehension impediments from the assessment portion of this project,
* A Montreal Cognitive Assessment (MoCA) score of \<13.
Study Comparing the Pharmacokinetic of Biosimilar Eptacog Alfa With Novoseven®, in Patients With Congenital Factor VII Deficiency

The purpose of this multicentre, randomized, double blinded, single dose, two-way cross-over study, is to compare the pharmacokinetics (PK) of biosimilar eptacog alfa (activated) with Novoseven in 24 patients, adult and children (\>12 years), not bleeding, with inherited coagulation factor VII (FVII) deficiency (FVII \<1%). Patients will be randomized to receive either a single dose of eptacog alfa biosimilar 30 μg/kg and one single dose of NovoSeven 30 μg/kg, or vice versa, with doses separated by a washout period. All patients will be followed 12 months and will receive biosimilar eptacog alfa, on demand, for every bleeding episode that should occur - or - for prophylaxis, with the aim of monitoring of inhibiting antibody formation, lack of efficacy and collection of safety data.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a confirmed diagnosis of congenital, severe Factor VII deficiency (FVII \<1%), with \> 2 episodes of bleeding/year requiring treatment with FVII infusions, in non bleeding status.
* Patients for the Additional group for immunogenicity should be enrolled when in a bleeding episode requiring treatment with FVII.
* Male and female subjects
* Adult and children (\>12 years)
* Written informed consent. For minor patients, parent/legal guardian will provide consent and, when possible, patient assent will also be obtained. For compromised patients their designated proxy must provide informed consent.

Exclusion Criteria:

* Any other type of congenital or acquired coagulopathy (except congenital Factor VII deficiency), such as: liver disease (hepatitis), vitamin k deficiency, uremia, malignancy.
* Antibodies against Factor VII
* Patients entering the PK Study Group who have not suspended prophylactic regimen with Novoseven or AryoSeven (biosimilar eptacog alfa) 3 days before starting the trial (receiving first dose of study medication).
* Patients entering the Additional Group for Immunogenicity study, only, who have been exposed to AryoSeven before starting study \[patients who have received Novoseven (on demand or in prophylaxis) before starting study are allowed\]
* Platelet count less than 100.000 platelets/μl (at screening visit)
* Patients who have received routine (prophylactic) treatment with rFVIIa in the period between screening visit (visit 1) and visit 2 of this study (first dose administration)
* Any clinical sign or known history of arterial thrombotic event or deep venous- thrombosis or pulmonary embolism
* HIV positive with current CD4+ count of less than 200/μl
* Liver Cirrhosis
* Known hypersensitivity to the study medication
* Parallel participation in another experimental drug trial.
* Parallel participation in another marketed drug trial that may affect the primary end point of the study.
Evaluation of Allergy to Potato in a Large Cohort

Patients consulting in the Allergy Unit of the Arnaud de Villeneuve Hospital for whatever suspicion of allergy were asked to participate in the study. Besides a standard battery of respiratory allergens, native raw and cooked potato were tested by means of the prick to prick method, using a metal lancet.


Eligibility Criteria:
Inclusion criteria:

* patients aged 2 years or older
* consent obtained from patients or their parents/legal representative

Exclusion criteria:

* refusal to participate in the study
* antihistamine drugs taken before testing
* pregnant women
* vulnerable patients according to French regulation
Study of 'Vascular Competence' Profile and Endothelial Activation in the Hemolytic Uremic Syndrome in Children and Adults

The Hemolytic Uremic Syndrome (HUS) is a rare thrombotic microangiopathy (TMA), affecting both children and adults. HUS is characterized by the abnormal occurrence of diffuse thrombosis in the microcirculation resulting in the occurrence of ischemic events affecting especially the kidneys and is associated with hemolytic anemia. One of the major problems encountered in the management of HUS is the absence of reliable marker of treatment response or relapse; conventional hematological markers being too insensitive to judge therapeutic efficacy or identify early relapse. Data from the literature suggest that the endothelial cell is a major target of this syndrome. Our hypothesis is that an initial micro-endothelial activation plays a critical role in the initiation and / or relapse of the disease.The main objective of this study is to define a "vascular competence" profile in a population of patients with typical or atypical HUS; both in the acute phase and in remission of the disease.

The Hemolytic Uremic Syndrome (HUS) is a rare thrombotic microangiopathy (TMA), affecting both children and adults. HUS is characterized by the abnormal occurrence of diffuse thrombosis in the microcirculation resulting in the occurrence of ischemic events affecting especially the kidneys and is associated with hemolytic anemia.Its prognosis is severe, with a mortality of 1% in children, 10% in adults and the occurrence of renal failure in 50% of cases.In its typical form, HUS occurs in the aftermath of a diarrheic intestinal infection by bacteria which produce a Shiga toxin. In its unusual shape, which affects both children and adults, there are genetic abnormalities alternate way of regulating complement proteins explaining frequent relapses.One of the major problems encountered in the management of HUS is the absence of reliable marker of treatment response or relapse; conventional hematological markers being too insensitive to judge therapeutic efficacy or identify early relapse. Data from the literature suggest that the endothelial cell is a major target of this syndrome. Our hypothesis is that an initial micro-endothelial activation plays a critical role in the initiation and / or relapse of the disease through the sudden release of high molecular weight ultralarge von Willebrand factor (UL-vWHf) and procoagulant endothelial microparticles.The main objective of this study is to define a "vascular competence" profile in a population of patients with typical or atypical HUS; both in the acute phase and in remission of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a clinical diagnosis of typical or atypical HUS in acute phase

Exclusion Criteria:

* Patient with positive serological screening test for infection with the HIV.
* Patients with a history of cancer.
* Patients who have undergone organ transplantation or bone marrow.
* Patient with a vivid picture of autoimmune thrombotic thrombocytopenic purpura
Effects of Music and Comedy Application on Pain and Kinesyophobia in Patients With TKA

Total knee arthroplasty (TKA) is a surgical procedure used to restore painless joint function and increase patients' activities of daily living in patients with progressive knee osteoarthrosis. Kinesiophobia can be seen in patients suffering from pain. It is stated that the incidence of kinesiophobia in TKA patients is 24.4%. Based on this information, this study was planned.

Total knee arthroplasty (TKA) is a surgical procedure used to restore painless joint function and increase patients' activities of daily living in patients with progressive knee osteoarthrosis. Kinesiophobia can be seen in patients suffering from pain. It is stated that the incidence of kinesiophobia in TKA patients is 24.4%. Pain etc. While conditions can be relieved by pharmacological treatment methods, non-pharmacological treatments can be effective in relieving patients' pain. With the relief of pain, it will be possible to eliminate the kinesiophobia experienced by the patients. It is known that humor, which is among the non-pharmacological treatment methods, increases the pain resistance of the patients, reduces the stress hormone, and strengthens the immune system. It is reported in the literature that listening to music, another non-pharmacological treatment, is also effective in relieving pain after TKA. For this reason, the study was planned to determine the effect of postoperative music and comedy films on kinesiophobia and pain in patients undergoing TKA.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 who agreed to participate in the study,
* Patients undergoing TKA
* Patients without a disabling psychiatric disorder

Exclusion Criteria:

* Patients under the age of 18 who do not agree to participate in the study.
* Those who have a psychiatric diagnosis that prevents communication.
AI-Driven Intervention for PrEP Service Utilization Among Chinese MSM: A HAPA and CEI Integrated Model

The goal of this clinical trial is to evaluate the effectiveness of a novel, intelligent intervention platform in bridging the "intention-behavior gap" for pre-exposure prophylaxis (PrEP) uptake among men who have sex with men (MSM) in China, a population at high risk for HIV infection. The study aims to address the following main questions:

* Can the intervention platform, guided by the Health Action Process Approach (HAPA) and Conditional Economic Incentive (CEI) dual-track theoretical framework, significantly increase PrEP initiation rates among MSM?
* What are the key mechanisms and pathways underlying the transition from PrEP intention to actual usage behavior?

Researchers will compare participants receiving the intelligent intervention platform (intervention group) with those receiving basic PrEP information (control group) to determine the platform's impact on PrEP initiation rates. Participants will:

* Use a mobile health platform equipped with personalized HIV risk assessments, PrEP knowledge resources, action planning tools, peer support features, and economic incentives.
* Complete baseline and follow-up surveys at 3 months and 6 months to assess PrEP initiation, adherence, and related behaviors.
* Engage in peer group activities and receive tailored feedback based on their progress.

This study seeks to provide evidence for scalable and sustainable strategies to improve PrEP uptake and contribute to HIV prevention efforts in high-risk populations.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years at enrollment;
* Assigned male at birth with a history of ≥1 male-male sexual encounter (anal or oral intercourse);
* HIV-negative confirmed by antibody testing at baseline;
* No prior use of PrEP;
* Expressed interest in PrEP intervention and commitment to complete scheduled follow-ups and data collection procedures;
* Mentally competent to provide informed consent and participate in decision-making;
* High HIV risk (meeting ≥1 of the following in the past 6 months): (1) Condomless anal/penile-vaginal intercourse; (2)Shared needle use during illicit drug injection; (3) Sexual contact with HIV-positive partner(s); (4) Newly diagnosed STI; (5) Repeated use of PEP for HIV prevention; or (6) Self-identified as PrEP candidate through voluntary request.

Exclusion Criteria:

* Confirmed HIV-positive status or unknown serostatus with refusal of HIV testing;
* Clinically significant health conditions contraindicating PrEP use (e.g., creatinine clearance \<60 mL/min, documented hypersensitivity to PrEP components);
* Severe mental illness or neurological disorders impairing informed consent process.
Study of Adherence Effects and Clinical Outcomes of Kaletra Based HIV Antiviral Therapy

The purpose of this study is to evaluate the effects of adherence on HIV antiviral response to treatment regimens containing Kaletra or other HIV protease inhibitors.


Eligibility Criteria:
Inclusion Criteria:

* Subject is documented HIV positive
* Subject is greater than or equal to 18 years of age.
* Subject currently on a regimen of either NNRTI + 2 Nucleoside Reverse Transcriptase Inhibitors NRTIs), two or three NRTIs who have failed regimen as evidenced by two consecutive viral loads with values over 1,000 copies/mL, the last one within the last three months, or
* Naïve subjects to ARV regimen who are required to begin a PI containing HAART regimen, or
* Subjects who have become intolerant to their current antiretroviral regimen and are required to be changed to a first time PI containing HAART regimen.
* Subject had laboratory testing within the previous three months and the most recent testing demonstrates all of the following: Hemoglobin \>8.0 g/dL; Absolute neutrophil count \>750 cells/mL; Platelet count \>20,000/mL; ALT or AST \<3 x Upper Limit of Normal (ULN); Creatinine \<1.5 x ULN; Triglycerides \<750 mg/dL.
* Subjects have no have evidence of grade III or IV adverse event or laboratory abnormality.

Exclusion Criteria:

-
Mobilization With Movement in Patients With Osteoarthritis of the Hip

The concept of mobilization with movement, also referred to as a Mulligan mobilization, has not been studied in patients with hip osteoarthritis, subsisting questions about the possible effects in this population. The aim of this randomized controlled study is to compare the immediate effects of Mulligan mobilization with movement technique of pain, range of motion and physical function in patients with osteoarthritis of the hip.

Mulligan original theory for the efficacy of a Mobilization With Movement (MWM) is based on the concept associated with a "positional joint failure," which occurs due to injury and may lead to a change in the joint alignment and hence its biomechanical resulting in symptoms such as pain, joint stiffness or weakness. To perform the MWM technique it is required to implement many criteria. During execution is applied an maintained accessory glide in order to correct the positional fault, while a physiological movement or action that usually caused the pain is performed actively or passively. A key component for the MWM is that pain should always be reduced and / or eliminated during application.

All study participants will be submitted to an initial assessment protocol to determine the intensity of pain, the range of motion (ROM) in flexion and internal rotation of the hip and the collection of physical function parameters. After that, the intervention will be performed for each group, and then the re-evaluation will be carried out (final evaluation), pain intensity, ROM and physical function tests..

Eligibility Criteria:
Inclusion Criteria:

clinical criteria for the diagnosis of osteoarthritis of the hip (sensitivity 86% and specificity 75%) are:

* Medial hip rotation ≥15º, pain during medial rotation of the hip, morning fatigue in hip\> 60 minutes and older than 50 years or
* Medial hip rotation \<15, hip flexion ≤ 115

Exclusion Criteria:

* Previous surgery or hip replacement or knee joint
* Another surgery in the lower extremities performed within 6 months, rheumatoid arthritis
* Uncontrolled hypertension or risk (moderate - high) of cardiac complications during exercise
* Disability unrelated to the hip or knee to prevent the safe participation during exercise, appliance of manual therapy or during march: vision problems affecting mobility, body weight equal to or greater than 155 kg, primary neurogenic disorder or significantly limitation of the lumbar level,advanced osteoporosis with manual therapy or other treatment technique that may interfere with the study
* With inability to understand the instructions and complete the study assessments
Cardiac Rehabilitation Mobile-Health Fall Risk Prevention Intervention

The purpose of this research is to see if taking part in a structured exercise plan that is designed to improve balance and muscle strength and one that can done at home helps to improve the ability to perform standard physical tasks, confidence in balance, and health-related quality-of-life

Traditional cardiac rehabilitation programs typically prioritize aerobic exercise (e.g., walking, cycling, etc.) with much less emphasis on improving physical function and strength, which is very important in, for example, decreasing the risk of falling. Through this research, researchers will implement a comprehensive fall risk screening and physical function assessment supported with individualized therapeutic exercise(s). Researchers hope that this will decrease fall risk, enhance rehabilitation experience, and improve ability to perform tasks of daily living.

Eligibility Criteria:
Inclusion Criteria:

* All patients referred to and who undergo early outpatient CR irrespective of diagnosis will be eligible for the study.
* All participants must have access to a smart mobile device.

Exclusion Criteria:

* Advanced dementia.
* Wheelchair bound.
* Vision loss.
* Patients that underwent sternotomy within 12-weeks will be excluded from the upper body muscular strength/power assessment and associated upper body training. At the time of enrollment into CR, balance, upper body muscular fitness, and lower body muscular fitness will be assessed in each subject before they are randomized at a 1:1 allocation ratio into one of two parallel groups:
* Standard early outpatient center-based supervised CR only (control; CR); or
* Early outpatient center-based supervised CR plus individualized, home-based, m-Health delivered physical function training (experimental group; CR+PFt). Balance, upper body muscular fitness, and lower body muscular fitness and gait will be reassessed in each participant after 5-to-6 weeks of CR and again upon completion of the CR program. Patient reported measures of fall risk will be measured at baseline with the Stop Elderly Accidents, Deaths, and Injuries (STEADI) tool kit. Balance confidence, health-related quality of life, physical activity level, and functional capacity will be evaluated before and after CR and CR+PFt using the Activities-Specific Balance Confidence (ABC) Scale, the Dartmouth Primary Care Cooperative Information Project (COOP) charts, and the Duke Activity Status Index (DASI).
Effect of Antibiotics on Penile Microbiome and HIV Susceptibility Study in Ugandan Men

This pilot study will assess the impact of four antimicrobial products (3 topical, one systemic) on the foreskin microbiome and HIV susceptibility of foreskin-derived CD4+ T cells. Participants will include HIV-uninfected Ugandan men presenting for elective male circumcision to reduce their HIV risk.

RATIONALE: The foreskin is the site of most HIV acquisition in uncircumcised heterosexual men, and male circumcision (MC) reduces HIV risk by almost 60%. However, cultural and practical barriers have led to suboptimal uptake. Foreskin inflammation, defined by elevated levels of pro-inflammatory cytokines in the prepuce, is a key determinant of HIV acquisition risk in uncircumcised men, and anaerobic bacteria within the foreskin microbiome may be an important cause of this inflammation.

OBJECTIVES: A pilot in vivo - in vitro clinical study of four potential interventions to reduce HIV susceptibility in the foreskin by altering the microbiome. The study is a collaboration between the University of Toronto, IAVI-UVRI, and the Entebbe General Hospital. We will recruit 125 men presenting for elective MC, along with regular female sexual partners (if applicable). Participants will be randomized (n=25 per group) to immediate MC, or to one of four intervention arms: twice-daily application of topical metronidazole 0.75%; twice-daily application of topical clindamycin 2%; twice daily application of hydrogen peroxide 1%; or oral tinidazole 2g once a day for two days. Swabs for immune and microbiome studies will be collected before and after product. After 4 weeks the MC procedure will be performed; foreskin CD4+ T cell susceptibility to HIV will be quantified using a flow cytometry-based pseudovirus assay, and tissue immunohistochemistry performed. The primary and secondary endpoints are outlined below. A secondary study will assess the impact of penile topical antibiotic application on immunology and the microbiome in the genital tract of female sexual partners.

OUTCOMES: This in vivo - in vitro clinical trial will define the causal role of the penile microbiome in HIV susceptibility, and will assess potential strategies to take forward into HIV efficacy trials in uncircumcised heterosexual men.

Eligibility Criteria:
Enrollment criteria include:

1. Aged 18 years or older
2. Biological male
3. Uncircumcised
4. HIV seronegative
5. Willing to comply with the requirements of the protocol
6. No current sexually transmitted infection (N. gonorrhoeae or C. trachomatis)
7. No clinically relevant genital symptoms / signs
Intrathecal Dexmedetomidine Versus Intrathecal Morphine Inpatients Undergoing Cardiac Valve Replacement Surgeries

Comparison between the effects of intrathecal morphine versus intrathecal dexmedetomidine on analgesia and respiratory function, in open heart surgery.

Postoperative pulmonary dysfunction is a well-recognized complication of open-heart surgeries. About 25% of patients who don't present with any severe impaired cardiac function reported to have significant pulmonary dysfunction for at least one week after operation. Many mechanisms could be accused of this dysfunction as respiratory mechanics failure by diaphragmatic paresis or paralysis, pain and muscle guarding, lung atelectasis, drains discomfort, etc.

although pain is the major concern of patients, but sometimes it may not get the proper attention, pain in open heart surgery origins mainly from the surgical incision which is here a median sternotomy the most commonly used approach and the easiest access to the heart region, however median sternotomy may significantly impedes the pulmonary function by the resultant pain of this procedure and cause morbidity and mortality by itself

Eligibility Criteria:
Inclusion Criteria:

- Cardiac patient scheduled for elective open heart valve replacement surgery.

Exclusion Criteria:

* • Patient refusal

  * Coagulation disorders
  * History of known allergy to the used drugs.
  * Combined procedures (e.gif combined with coronary artery bypass or aortic root surgeries).
  * If thoracotomy or min-sternotomy is planned for the surgery.
  * Re-do and emergency surgeries.
  * History of chronic chest diseases (COPD or IPF).
  * History of thoracotomy, pneumothorax, pneumomediastinum, phrenic nerve injury (as evident by the presence of paralysis of the ipsilateral hemidiaphragm when examined preoperatively).
  * Neuromuscular diseases.
  * Brain injuries.