cyrilzakka/clinical-trials huggingface dataset:
Comparison of the Effects of Apixaban on Thrombin Generation in Patients With de Novo Multiple Myeloma

Patients with multiple myeloma (MM) are at high risk of venous thromboembolism (VTE) and these patients require adequate thromboprophylaxis. Following the publication of the AVERT clinical study, Apixaban is strongly recommended as a prophylactic treatment option for patients with cancer, based on high quality of evidence and a favorable efficacy/safety profile. A multicenter and ancillary study - APIXABOR - that measured the plasmatic concentration of Apixaban in patients with MM and treated with preventive dose has been conducted. The peak drug concentration was superior in MM plasma, as compared to non-myeloma patients under prophylaxis. Therefore, the present study evaluated whether differences in pharmacokinetics have an impact on pharmacodynamics (i.e. decrease in coagulability in MM patients as compared to non-MM patients undergoing a surgery for total knee replacement who also have VTE prophylaxis). In fine, this study may inform to better manage thromboprophylaxis in MM patients.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old,
* Signed informed consent,
* Patient covered by a social security scheme.
* Group 1 : patient with a diagnosis of de novo multiple myeloma, with an indication of thromboprophylaxis with Apixaban,
* Group 2 : patient requiring a surgery for total knee replacement, , with an indication of thromboprophylaxis with Apixaban.

Exclusion Criteria:

* Curative doses of anticoagulation treatment,
* Contra-indication to Apixaban,
* Pregnant or breastfeeding woman,
* Refusal to sign consent,
* Patient under legal protection.
Effects of Physical Exercise Timing On Strength and Cardiometabolic Health

Physical exercise is well known to improve human health. Current guidelines provide recommendations on the frequency, intensity, type and duration of exercise. However, they do not provide recommendations for the time of day, exercise should be performed. This is surprising considering that the influence of timing of behaviors such as sleep or nutrition as well as the impact of the circadian timing system on health are well documented. Further, there is evidence for diurnal variation in maximum performance which enables individuals to exercise with different intensities at different times of day, which in the long term might affect physical adaptations to exercise. Thus, this research study investigates if exercise timing impacts human health.


Eligibility Criteria:
Inclusion Criteria:

* BMI 18.5 - 30 kg/m2

Exclusion Criteria:

* Structured resistance training within the last six months
* Ongoing shift work
* Irregular bedtime (\> 2 hours variation in habitual bed time)
* Smoking
* Travels across more than two time zones within the last four weeks
* Inability to follow the study procedures (e.g. due to language barriers, psychological disorders, dementia, etc.)
* Known pregnancy or lactating women
* Participation in any other clinical trial within the last four weeks
* Medical condition that is a contra indicator for resistance training, endurance training, or exercising until maximum exhaustion including insufficiently controlled blood pressure (systolic \> 170 mmHg, diastolic \> 100 mmHg), ongoing cancer treatment, unstable angina pectoris, uncontrolled bradyarrhythmia or tachyarrhythmia, severe uncorrected valvular heart disease, clinically relevant acute infection, any form of musculoskeletal injury, orthopedic problems or decompensated cardiovascular disease
* Insulin dependent diabetes
* Participants using metformin
Does Implant Design Improve Postoperative Flexion?

This study will evaluate whether design features of one implant design allows more knee bend than the other. Patients will have 1 design in the left knee and 1 design in their right knee. Both knee surgeries will be on the same day.

The primary objective of this study is to determine whether the passive, non-weight-bearing flexion is superior with the posterior-stabilized PFC® Sigma™ RP-F compared to the posterior-stabilized PFC® Sigma™ RP in bilateral Subjects receiving both implants and if this difference is a function of implant design.

Eligibility Criteria:
Inclusion Criteria:

* Non-Inflammatory Arthritis
* Age = 40-70 years
* Male or female
* Suitable for devices in study
* Needing primary simultaneous bilateral knee replacements
* Willing to consent and authorize release of personal health information
* Subjects who are able to understand this clinical investigation, co-operate with investigational procedures and are willing to return to the clinic, hospital and predefined physical therapy centers for all the required postoperative follow-ups,

Exclusion Criteria:

* Existing conditions that would compromise participation
* Multiple joint involvement
* Pregnant/lactating women
* Inflammatory arthritis
* Fixed flexion contracture greater than 20 degrees
* Previous knee replacement of any type
* Needing device(s) not specified in protocol
* The Subject is a known drug or alcohol abuser or has a psychological disorder that would compromise follow-up
* Those who have participated in an investigation in the last 3 months
* Those involved in personal injury litigation, medical-legal or workers compensation claims
* Failure to follow surgical technique details specified in the protocol
A Within Subject Comparison of Opioid Withdrawal in Opioid Dependent Individuals

Buprenorphine is an approved medication for the treatment of opioid dependence. It is typically administered once daily as a sublingual tablet combined with naloxone (i.e., Suboxone). Evidence suggests buprenorphine produces relatively low levels of physical dependence. In addition, some research suggests there is relatively little withdrawal following cessation of chronically administered buprenorphine. This study will examine the spontaneous withdrawal associated with abrupt cessation of buprenorphine compared to morphine in opioid dependent individuals. This study will assess the characteristics and time course of withdrawal using subject-rated and observer-rated measures of opioid withdrawal. Physiologic measures and psychomotor performance will be collected during chronic opioid administration and during placebo administration (i.e., during spontaneous withdrawal). Particular attention will be paid to the differences (if any) in sleep disturbances and withdrawal associated hyperalgesia.


Eligibility Criteria:
Inclusion Criteria:

* Be adults ranging in age from 21-55 years old.
* Be dependent on opioids.
* Be willing to accept or desiring of opioid detoxification.
* He healthy as determined by medical screen, history, and vitals.
* Be without significant psychiatric illness besides drug dependence.
* Be without chronic pain.
* Fluent in English (speaking, writing, and reading).
* Be willing and able to participate.

Exclusion Criteria:

* Previous documented allergy to buprenorphine or morphine.
* Are dependent on other drugs besides opioids and tobacco.
* Have current history of significant use of alcohol or sedative/hypnotics.
* Have evidence of significant medical (e.g., insulin dependent diabetes mellitus) or psychiatric (e.g., schizophrenia) illness.
* Are pregnant (female volunteers will receive a pregnancy test before participation in the study and routinely during the study).
* Have an abnormal or prolongation of the corrected QT interval (QTc) on a baseline electrocardiogram (ECG).
* Are seeking treatment for their substance dependence.
Associations of Fecal Bile Acid Profile and Intestinal Flora With Chronic Radiation Enteritis

To explore the fecal bile acid profile of patients with radiation enteritis, to clarify the types of bile acids that are closely related to the occurrence of radiation enteritis; to explore the interaction between fecal bile acids and intestinal flora in patients with radiation enteritis, and to lay the foundation for further elucidation of the pathogenesis of radiation enteritis.


Eligibility Criteria:
Inclusion Criteria:

1. . non-surgical cervical cancer patients aged 18 to 75 years who received radiotherapy;
2. . Patients who can fully understand the content of informed consent for this trial and voluntarily sign the written informed consent;
3. . able to receive follow-up examinations, follow-up examinations, and specimen retention on time;
4. . The case group met the diagnostic criteria for chronic radiation enteritis in the "Expert Consensus on the Diagnosis and Treatment of Radiation Proctitis in China (2018 edition)"; Control group 1: Non-surgical cervical cancer patients without chronic radiation enteritis after radiotherapy; Control group 2: Patients with cervical cancer who did not receive any treatment.

Exclusion Criteria;

1. . Presence of diseases affecting bile acid metabolism, such as hepatitis and cirrhosis of the liver from various causes, gallstones, etc;
2. . Patients who have previously undergone cholecystectomy or partial resection of the intestine;
3. . Taking drugs affecting bile acid metabolism due to other diseases, such as cholestyramine, anti-inflammatory and Xiaoyan lidan tablets, Danshu capsules, ursodeoxycholic acid, obeticholic acid, and proprietary Chinese medicines such as schisandrin B, Tanshinone IIA, and Yinjiazhuang;
4. . Recent use of drugs that affect gastrointestinal motility;
5. . Patients with moderate or severe renal impairment (blood creatinine \> 2 mg/dL or 177 mmol/L), or abnormal liver function (ALT \> 2 times the upper limit of normal value); moderate or severe chronic obstructive pulmonary disease; patients with severe hypertension, patients with cerebrovascular accidents; patients with congestive heart failure, unstable angina pectoris;
6. . Patients with mental or legal disabilities;
7. . Suspected or confirmed history of alcohol/substance abuse or other pathology that, in the judgment of the investigator, reduces the likelihood of enrollment or complicates enrollment;
8. . Refuse to sign informed consent;
Montessori Intervention for Individuals With Dementia: A Feasibility Study From Pakistan

The study has both quantitative and qualitative components.

The objective of the quantitative study is:

1. To culturally adapt and refine Montessori activities for people living with dementia in Pakistan.
2. To determine the feasibility and acceptability of culturally-adapted group based Montessori intervention for people with dementia in Pakistan.
3. To build capacity and capability in dementia research (researcher training)

The objective of the qualitative study is:

To explore views on perceived effectiveness and sustainability of the study.

Pakistan is the sixth most populous country in the world. Mental health services are limited in Pakistan particularly older adults mental health services are almost nonexistent. According to a recent report in Pakistan currently 8 million people are of age 65 and above who have long term physical and psychological health conditions. This is a tough challenge for the country due to its poor economic condition.Hence, there is a need to develop programs that can help and improve the health-related quality of life of this population in low resource settings.We need to do a lot more work to address this issue.

One possible low-cost, accessible, non-pharmacological intervention for BPSD (Behavioral Psychiatric symptoms of dementia) is the Montessori approach which is evidence based.The aim of the proposed project is to explore the feasibility and acceptability of using the Montessori intervention for people with dementia in Pakistan.

Eligibility Criteria:
Inclusion Criteria:

* Participants with the following characteristics will be invited to participate in the study;

  * Diagnosed with any type of dementia according to DSM V.
  * Montreal Cognitive Examination Scale with a cutoff score 10
  * Age 60 years or older
  * Residents of study catchment area
  * Able to communicate in Urdu or English
  * Not having any serious visual or hearing impairment
  * Capacity to consent to study participation
  * Willing to come to (care home, hospitals, research centre) for session.
  * Willing to participate in up to 60 minutes session of the intervention, twice a week.
  * Having a study partner (spouse or adult child caregiver) who agrees to participate in the study

Exclusion Criteria:

* Participants with the following characteristics will not be eligible for the study;

  * Advanced stage dementia
  * Participants diagnosed with severe mental or physical illness which, in the judgement of the PI, precludes them from safely participating in the study.
  * Unable to give consent to take part in the study
A Study of STRO4 in Patients Amyotrophic Lateral Sclerosis (ALS)

This study intends to evaluate the safety and efficacy of STR04 administered intravenously in participants with Amyotrophic Lateral Sclerosis.

This study is a 69 week open label study of autologous bone-marrow-derived mesenchymal stem cells (STR04) in participants with ALS.

Participants will undergo a screening visit, followed by collection of peripheral blood and bone marrow for the manufacture of STR04. Once manufacturing is successfully completed, participants will have a Baseline visit followed by 4 doses of STR04, one dose every 12 weeks. Participants will have a final assessments 12 weeks after the 4th dose.

Eligibility Criteria:
Inclusion:

* "Definite" or "Probable" ALS according to the Revised El Escorial criteria (Airlie House)
* ALS severity grade 1 or 2 according to the Japan ALS severity classification.
* ALSFRS-R scores of 2 or more for all items, with scores of 4 for all breathing- related items (i.e., dyspnea, orthopnea, respiratory insufficiency).
* Within 2 years of ALS onset.
* %FVC of 80% or more.
* Aged 18 to ≤75 years at the time of informed consent.

Exclusion:

* Current Viral Infection (e.g. HBV, HCV, HIV, HTLV-1, HPVB19, syphilis, COVID- 19).
* Current low blood cell counts
* History of cancer, congenital malformations, or chromosomal abnormalities
* History of allergy to penicillin or streptomycin, or other serious allergies.
* Current poor medical condition, due to endocrine disease, metabolic disease, immune disease, blood disease, psychiatric disorders, neurological diseases, cardiovascular diseases, respiratory diseases, gastrointestinal diseases, musculoskeletal or connective tissue diseases, renal or urogenital diseases.
* History of intracranial lesions, or stenosis, dissection or severe atherosclerotic disease of a blood vessel in the head or neck.
* Current uncontrolled hypertension.
* Prior treatment with a cell or gene therapy.
* Currently participating in any other clinical trial.
* Women who are pregnant, breastfeeding, or plan to become pregnant during study participation
* Men with plan for their partner to become pregnant during study participation.
PreHospital Air Medical Plasma Trial

To determine the effect of the prehospital infusion during air transport of 2 units of AB plasma on 30 day mortality in patients with hemorrhagic shock as compared to conventional care.

Background: Although advances in the care of the severely injured patient have occurred over the last decade, patients continue to be plagued with uncontrolled hemorrhage resulting in significant early mortality and the development of multiple organ failure and associated complications. A primary driving force for this unbridled hemorrhage has been shown to be the early coagulopathy which complicates severe injury. Increasing evidence suggests that blood component transfusion protocols that address this early coagulopathy, once a patient arrives at a trauma center, are associated with lower mortality and a reduction in blood component transfusion requirements. Prehospital interventions which quell this early coagulopathy in an earlier setting have the potential to minimize or even prevent this vicious hemorrhagic cascade, further lowering blood component transfusion requirements and reducing the resultant morbid sequelae which complicates severe injury.

Objective/Hypothesis: The primary hypothesis will be that prehospital infusion of plasma during air medical transport in patients with hemorrhagic shock will lower 30 day mortality. The secondary hypotheses include that prehospital infusion of plasma will reduce 24 hour blood transfusion, multiple organ failure, nosocomial infection, and acute lung injury, reduce or prevent the early coagulopathy as demonstrated by improving presenting coagulation and thromboelastography parameters, and reduce the early inflammatory cytokine response, thrombomodulin and increase protein C levels.

Eligibility Criteria:
Inclusion Criteria: Hemorrhagic shock not responsive to crystalloid infusion -

Exclusion Criteria: Isolated Fall, Cervical cord injury, prisoner, pregnant patient, traumatic arrest

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Comparison of Different Tools Inserted Nasal Endotracheal Tube

Nasotracheal intubation (NTI) is usually required in patients undergoing maxillofacial surgery. Though video-scopes have been demonstrated to well perform in oral endotracheal intubation, limited information presents in NTI. The aim of the study is to compare the efficacy of video-scopes in NTI and compared with the traditional direct laryngoscope.


Eligibility Criteria:
Inclusion Criteria:

* patients with American Society of Anesthesiologists physical status I-III
* aged 20-65 years
* Requiring Nasotracheal Intubation under general anesthesia

Exclusion Criteria:

* mouth open \< 3 cm
* limited neck extension \< 25 degree
* Ankylosing arthritis patients.
* BMI≧35 kg/m2
Botanical/Drug Interactions in HIV: Glucuronidation

A series of clinical studies will be conducted in normal, healthy adult volunteers to evaluate the potential for alterations in the pharmacokinetics of anti HIV drugs when botanicals/nutriceuticals are given concurrently via the oral route. Both the drugs and botanicals are known to rely upon or to modulate, respectively, metabolism via glucuronidation.

As per Brief Summary

Eligibility Criteria:
Inclusion criteria:

* Absence of HIV-1 infections

  * Body mass index less than or equal to 30 kg/m2 and weigh at least 50 kg.
* Laboratory values obtained within 7 days of study entry within normal range for healthy volunteers.
* Able to be compliant with dosing schedules and diary record keeping.
* Able to follow dietary restrictions associated with the protocol.
* Ability and willingness to provide informed consent
* All women of reproductive potential must have a negative pregnancy test
* All women of reproductive potential to use contraception methods as defined by protocol
* All study subjects (male and female) must agree to not participate in a conception process

Exclusion Criteria:

* History of any acute or chronic illness that requires current medical therapy including active gastrointestinal conditions that might interfere with drug absorption.
* History of hepatic, renal, cardiovascular, gastrointestinal diseases.
* Current gastrointestinal disturbance.
* Receipt of any prescribed or over the counter medication or ingested CAM during the 30 days prior to study entry except: Over the counter acetaminophen or ibuprofen at doses not exceeding package labeling guidelines.
* Any medical condition that, in the opinion of the investigator, would interfere with the subject's ability to participate in this protocol.
* Pregnancy or breastfeeding.
* Allergy/sensitivity to study agent(s) or their formulations.
* Active drug or alcohol abuse or dependence, which in the opinion of the investigator would interfere with adherence to study requirements or would endanger the subject's health while on study.
* Before entering the study, subjects must agree not to consume alcohol for 48 hours prior to PK sampling days.
* Participation in any investigational drug studies within 30 days prior to study entry and during study.
The Impact of Obesity on Short Stem Total Hip Arthroplasty

The purpose of this study is to review the impact of obesity on subsidence and clinical outcome after short stem total hip arthroplasty.

Short stem total hip arthroplasty (THA) has gained popularity due to its bone-sparing technique, but its outcomes in obese patients remain uncertain.

While studies on the mid-term outcome in a general patient cohort provide excellent results in terms of the clinical and radiological outcome as well as the complication rate of short stem THA, data on its use in obese patients is still rare and not sufficiently conclusive. Some studies have found no evidence of increased subsidence in obese patients, while other studies have shown contrary trends.

In this context, the aim of this study was to investigate the relationship between BMI, postoperative subsidence and clinical outcomes in the setting of short stem THA.

Eligibility Criteria:
Inclusion Criteria:

1. patients who underwent primary short stem hip arthroplasty with Mathys Optimys short stem between 01.01.2018 and 31.12.2020
2. availability of preoperative and postoperative radiographs for assessment of subsidence
3. a minimum BMI of 30kg/m2 for the obese group
4. a minimum follow-up of 24 months.

Exclusion Criteria:

1. former surgeries of the hip in question
2. incomplete clinical data
3. incomplete radiological data
Improving Medication-taking After Liver Transplant

The specific aim is to pilot-test our developed intervention manual's ability to improve patients' adherence to medications and medical outcomes (rejection rate, liver enzyme levels) in participating centers.

Nonadherence (not taking the medications as prescribed) is the most common cause of late acute rejection in children who have had a liver transplant, and thus is associated with graft loss, increased expenditures on care, and ultimately death. Researchers in this application developed a biomarker to identify nonadherence, calculating the standard deviation (SD) of consecutive immunosuppressant blood levels for each patient to capture the degree of variability between individual levels (higher SD = less consistent levels). By applying a threshold, this marker identifies nonadherent patients. A consortium of transplant centers is currently testing this marker through the MALT (Medication Adherence in children who had a Liver Transplant) study. MALT investigators now propose to take advantage of this existing collaboration to pilot-test an intervention to improve adherence in patients who are identified by this marker.

Eligibility Criteria:
Inclusion Criteria:

* The patient is between 11-19 years of age at enrollment.
* Guardian's consent, child assent (in accordance with each institution's IRB policies).
* The patient is prescribed tacrolimus (either brand or generic formulation).
* The patient has been seen in the enrolling center's clinic at least once in the last two years.
* The patient's SD of tacrolimus was \> 2.0 in the year prior to enrollment, with at least 3 levels present to make this determination.
* The patient and at least one guardian speaks English or Spanish at a level that allows her / him to understand the study procedures and consent to the study.

Exclusion Criteria:

* The patient received a liver transplant less than 1 year prior to enrollment.
* The patient has had more than one transplant (including marrow replacement).
* The patient has had biopsy-proven rejection within the past six months.
* The patient has been diagnosed with Hepatitis C.
* The treating physician has instructed the patient not to obtain tacrolimus levels for at least one year in the past year.
* The guardian or child (in a developmentally-appropriate manner) do not understand the study procedures. This will be verified by asking both guardian and child to repeat the study procedures.
* The patient is only seen for consultation - most or all of the child's routine care is provided at another center (or in a community clinic).
* Either the patient or the guardian is actively psychotic or severely disoriented due to any cause, including hepatic encephalopathy (temporary exclusion) or severely mentally retarded as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV).
* The patient is not medically stable or is hospitalized.