cyrilzakka/clinical-trials huggingface dataset:
Perioperative Hemostasis Management in Liver Transplantation

Liver transplantation (LT) is a surgery with risk of bleeding. Several risk factors have been identified: complex dissection, portal hypertension, history of ascites fluid infections, history of surgical procedures, pre-existing complex hemostatic disorders and those acquired during the procedure. Diffuse bleeding can occur at any time during the 3 phases of surgery: dissection, anhepatic and neohepatic. However, intraoperative bleeding and transfusion requirements remain difficult to predict. Current predictive models are based in particular on preoperative characteristics and do not take into account the course and different phases of the operation.

The need for transfusions has largely decreased over the last 20 years, and currently around 20-25% of patients are transfused (transfusion of at least 1 blood product during LT). However, massive transfusion is necessary in 10% of LT. The European Society of Anaesthesiology (ESA) has issued recommendations on the management of severe bleeding during surgery. However, these recommendations are not specific to LT. Moreover, transfusion strategies vary widely from one center to another. The implementation of protocols within teams dedicated to LT has led to a reduction in bleeding and transfusion, with or without the use of viscoelastic testing.

Intraoperative bleeding and transfusion requirements, as well as postoperative thromboembolic complications, remain difficult to predict. Predictive models of bleeding risk have been developed, but they are based solely on preoperative characteristics and do not take into account the course and various phases of the operation. In addition, new methods such as Bayesian inference or machine learning have been developed, and seem capable of providing different information from that obtained by conventional models.

The overall aim of this prospective multicenter observational study is to investigate the risk factors for bleeding and thrombosis in per- and post-operative LT using different predictive methods, and to describe the management of bleeding and post-operative anticoagulation in metropolitan France.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 or over
* Liver transplant patient

Exclusion Criteria:

* Multi-organ transplantation
* Protected populations: under guardianship or curatorship
* Patients not affiliated to a social security scheme
Safety and Effectiveness Assessment of PeGagen® (Pegfilgrastim) in the Prevention of Chemotherapy-induced FN

The present study was an observational, multicenter, non-interventional, single arm, open label, PMS study conducted in Iran.

The primary objective of this study was safety assessment, including the rate of AEs. The secondary objective was the effectiveness evaluation in the prevention of chemotherapy-induced FN.

The present study was an observational, multicenter, non-interventional, single arm, open label, PMS study conducted in Iran.

Data was gathered in two booklets, each containing information on four cycles of chemotherapy, which was filled by the designated physician. The duration of PegaGen® treatment was at the physicians' discretion based on the patient's condition.

The primary objective of this study was safety assessment, including the rate of AEs. The secondary objective was the effectiveness evaluation in the prevention of chemotherapy-induced FN.

This study was single arm and 654 subjects participated across various tumor types and regimens.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥18 years,
* with the diagnosis of various types of cancers (such as lymphoma, breast, lung, testicular, prostate, ovary and gastrointestinal cancers), receiving first-line chemotherapy regimens with a high FN risk, which PegaGen® is injected due to physician decision.
Appearance of Plasma Amino Acids Following Consumption of an Oral Nutrition Supplement

To assess the effect of consumption of an oral nutrition supplement on Arginine, a blood marker of nutritional intake


Eligibility Criteria:
Inclusion Criteria:

* Healthy subject (absence of metabolic disorder, heart disease, endocrine disease, cancer)
* Discontinued use of omega 3 fatty acid supplements - 10 days prior to testing
* Willing to provide signed informed consent

Exclusion Criteria:

* Smoker
* Patients with potential for non-compliance
* Patients with allergy to ingredients in test products (i.e. milk protein, fish oil)
* Subject who in the Investigator's assessment cannot be expected to comply with study protocol
* Currently participating in another conflicting clinical trial.
Evaluation of an Investigational Blood Glucose Monitoring System

The purpose of this study was to determine if untrained subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females, 18 years of age and older
2. People with type 1 or type 2 diabetes
3. Able to speak, read, and understand English
4. Willing to complete all study procedures

Exclusion Criteria:

1. Hemophilia or any other bleeding disorder
2. Pregnancy
3. Physical, visual, or neurological impairments that would make the person unable to perform testing with the BGM
4. Previously participated in a BG monitor study using the Ninja 3 BGMS
5. Working for a medical laboratory, hospital, or other clinical setting that involves training on and clinical use of blood glucose monitors
6. Working for a competitive medical device company, or having an immediate family member who works for such a company
7. A condition which, in the opinion of the investigator or designee, would put the person or study conduct at risk.

The enrollment criteria for the study population:

1. At least 60% of subjects will be younger than age 65
2. At least 20% of subjects will have type 1 diabetes
3. At least 50% of subjects with type 2 diabetes wil be insulin users.
Study to Investigate the Effect of Formulation and Food on the Pharmacokinetics of GDC-0810

This is a phase 1, randomized, open-label, single center, crossover study to investigate the effect of formulation and food on the pharmacokinetics of GDC-0810 in female healthy participants of non-childbearing potential. This study is divided into three parts. Participants in each part will be randomized to one of three treatment sequences. Part 1 study in 4 periods will investigate the effect of formulation on the pharmacokinetics (PK) of GDC-0810 administered with low-fat food. Each participant in this part will receive a single dose of GDC-0810 dose level A following consumption of a low fat meal (30 minutes after the start of the meal) in each treatment period. Part 2 is an optional Phase I study in 3 periods to investigate the effect of formulation on the PK of GDC-0810 administered with low-fat food in healthy female participants of non-childbearing potential. Part 3 study in three periods will compare the PK of a Phase III prototype tablet formulation selected from Parts 1 and 2 of the study with the Phase II tablet formulation (both administered 30 minutes after the start of a low fat meal) at dose level B and to investigate the PK of the Phase III prototype formulation administered in the fasted state.


Eligibility Criteria:
Inclusion Criteria:

* Female participants of non-childbearing potential including non-pregnant, non-lactating, and either postmenopausal or surgically sterile for at least 45 days post procedure
* Body mass index (BMI) range 18.0 to 32.0 kilograms per square meter (kg/m\^2), inclusive
* In good health, as determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs, and clinical laboratory evaluations
* Receive an explanation of the mandatory pharmacogenomics (PgX) component of the study

Exclusion Criteria:

* Any history of endometrial polyps, endometrial cancer, atypical endometrial hyperplasia, or other endometrial disorders unless subjects have undergone total hysterectomy and there is no evidence of active disease
* Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
* History of any thrombophilic condition, inflammatory bowel disease, active bowel inflammation, chronic diarrhea, short bowel syndrome, and upper gastro-intestinal (GI) surgery including gastric resection
* Any history of venous thrombosis (including pulmonary embolism \[PE\])
* Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 90 days prior to Check-in (Day -1) in Period 1
* Use of systemic hormone replacement therapy within 1 year prior to Check-in (Day -1)
* History of use of tamoxifen, aromatase inhibitors, or any other endocrine agent for the treatment of breast cancer
Meniscus Regeneration After Meniscectomy and Its Clinical Significance

Meniscus injury is common in sports-active population, and partial or total meniscectomy is standard surgery for meniscal tear. Meniscus plays an important role in load transferring, shock absorbing, knee joint stabilizing and chondral protection. Plenty of studies indicate that meniscus-deficiency increases the risk of OA and cause long-term poor outcomes.

Spontaneous human meniscus regeneration is rarely reported and whether regenerated meniscus is chondral-protective and can prevent OA progression remain unknown. During our clinical practice, we have encountered many cases with complete meniscal regeneration under arthroscopy. In this study, we will include all the patients who receiving meniscectomy and ACL reconstruction and knee arthroscopy 2 years after primary surgery. Patients demographic characters will be reviewed. The resected meniscus in the primary surgery and biopsied regenerated meniscus will be analyzed by histological and immunohistochemical method and their ultrastructure will be observed by electron microscope. Patients will be followed at 2-, 5- and 10-year after the primary surgery and the cartilage degeneration and OA progression will be assessed.


Eligibility Criteria:
Inclusion Criteria:

1. Patients intending to undergo single-knee ACL reconstruction at our Institute of Sports Medicine.
2. The age of 18 \~ 50 years old at the time of operation.
3. Both men and women.
4. BMI \< 24.
5. Complete or partial meniscectomy was performed at the same time as ACL reconstruction.
6. Patients willing to undergo a second arthroscopic exploration 2 years postoperatively and to take the portal screws used to fix the ligaments during the initial surgery.
7. Patients with preserved meniscus video during ACL reconstruction.
8. The degree of knee osteoarthritis (KOA) at the time of operation was \< Ⅲ of Kellgren Laurence level.

Exclusion Criteria:

1. Patients with severe knee cartilage injury.
2. Patients with KOA≥KLⅢ at the time of operation.
3. The patients cannot be followed up.
4. Patients who refused the second arthroscopy and the removal of the internal fixation portal screw at the time of surgery.
5. Patients with rheumatoid arthritis or other arthritis.
6. Patients with other systemic diseases who take oral anti-inflammatory analgesics for years.
7. Patients with multiple injections of drugs in the joint due to various reasons.
Yoga Intervention in Supporting Children With Cancer and Their Parents During Chemotherapy Infusion

This trial studies how well Yoga works in supporting children with cancer and their parents during chemotherapy infusion. Pediatric cancer and its treatment is one of life's most stressful events for children and their parents. Yoga is an ancient holistic healing science that incorporates postures, breathing, relaxation, and meditation to facilitate harmony between body, mind, and spirit. Participating in Yoga exercise may improve the negative psychosocial effects in children with cancer and their parents during chemotherapy treatment.

PRIMARY OBJECTIVES:

* To determine the feasibility of Yoga for children with cancer and their parents, specifically
* Identify possible required modifications for safe and feasible practice during infusions.
* Obtain recruitment estimates and determine barriers.
* Assess satisfaction.

SECONDARY OBJECTIVES:

* To determine the feasibility of administering and acceptability of measures to assess preliminary efficacy of Yoga for the following outcomes:
* Child psychological distress (stress, anxiety).
* Parent psychological distress (stress, anxiety, anger, depression).
* Child and parent physiological stress (heart rate, respiratory rate, and blood pressure).
* Parent-child communication.
* Child physical symptoms.

OUTLINE:

Patients and parents participate in up to 8 Yoga sessions consisting of check in, awareness, breathing practices, gentle movement, and relaxation over 30 minutes each.

Eligibility Criteria:
Inclusion Criteria:

* Children: 8-17 years of age, within 4 weeks of: 1) any new cancer diagnosis or newly diagnosed relapsed cancer, and 2) medical clearance who anticipate 3-weeks of continous contact with Monroe Carell Jr. Children's Hospital.
* Parents: 18 years of age and older, child's primary caregiver (planning to attend appointments, infusions visits, or be in hospital rooms/clinics) or secondary caregiver (an as needed back-up to primary).

Children and Parents: able to speak and understand English, absence of cognitive impairment, and willing to engage in Yoga as part of a dyad.

Exclusion Criteria:

* CHILDREN: Medical conditions that would prohibit the safe implementation of a Yoga practice
* PARENTS: Practices Yoga weekly
* PARENTS: Pregnant or plans to become pregnant during next 3 months
* CHILDREN AND PARENTS: Unwilling to work as a dyad.
Emotional Support Messages Following a Cancer Diagnosis

Cancer patients will be randomly shown one of 18 emotional support messages created by the research team that differ based on how much of the message consists of positive statements and how much consists of negative statements. The messages with negative statements also differ based on whether the negative statements occur at the start or end of the message. After viewing the message, participants have the opportunity to rate the effectiveness of the message, to what extent the message made them feel better, and to what extent the message affects how they view the message provider as a useful source of emotional support.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be 18 years of age or older
* Participants with a diagnosis of breast, prostate, thoracic or digestive cancer in the past 3 years
* Participants consented to Moffitt's Total Cancer Care (TCC) protocol and indicating a willingness to be contacted for future research by including an email contact.
* Ability to read and write fluently in English
Comparing High and Low Dose Iron Treatments for People on Peritoneal Dialysis: The PALaDIN Study

Chronic kidney disease affects a significant portion of the UK population, with approximately 3.5 million adults diagnosed. At its most severe stage, end-stage kidney disease, individuals require frequent dialysis treatment. One form of dialysis, known as peritoneal dialysis, involves introducing and removing fluid from the abdominal cavity to help filter out toxins from the body.

The kidneys are involved in various hormonal processes, including those responsible for producing red blood cells, making anaemia a common consequence of kidney failure. When designing a clinical trial to evaluate the effectiveness of any treatment, it is essential to determine the number of suitable and willing participants, as well as those who can complete all required tests and measurements. Identifying the most appropriate measurement to assess the impact of intravenous iron (iron injected directly into veins) is crucial to ensure that any observed changes are meaningful to people with CKD and their carers. To address these considerations, the investigators will conduct a pilot feasibility trial.

In this trial, individuals with kidney disease undergoing peritoneal dialysis will be randomly assigned to receive either high-dose or low-dose intravenous iron, or oral iron therapy. Over twelve months, the investigators will monitor their anaemia response, symptoms of kidney disease, quality of life, physical performance (such as the ability to walk for six minutes), and cognitive function. Additionally, the investigators will assess the impact of each intervention on the frequency of blood transfusions, whether those on oral iron require intravenous iron, and any changes in the dosage of erythropoietin-stimulating agents (drugs that increase blood production).


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged ≥18 years.
* Able to give informed consent
* Serum ferritin \<700ug/L
* Transferrin saturation level \<40%
* No intravenous iron for last 4 weeks before randomisation (patients may be pre-identified and included after 4-week washout period)
* Received maintenance peritoneal dialysis therapy for at least 4 weeks
* Expected to remain on peritoneal dialysis therapy for duration of study

Exclusion Criteria:

* Inadequate dialysis deemed by responsible clinician
* Probability of need for transfusion within 1 week of enrolment
* Anticipated major surgery that the responsible clinician feels will impact response to treatment
* Haemochromatosis / haemosiderosis or ALT \>x3 normal
* Are deemed to be most suited to best-supportive or end-of-life care at time of screening
* Women of childbearing potential not using effective means of contraception
* Have been involved in another medicinal study (CTIMP) within past 4 weeks
* Known allergy or adverse reaction to oral or intravenous iron preparations
* CRP \>50, TSATs \>40%, SF \>700 at time of recruitment
* Active infection, HIV, active Hep B or C
* Are unable or unwilling to consent to or complete the study procedures
Prevention of Neuropathic Pain From Oxaliplatin by Photobiomodulation

Peripheral neuropathy is one of the most common side effects of oxaliplatin (OXA)-based chemotherapy for patients treated for digestive cancers, disabling and dose-limiting. Several strategies have been studied for the treatment of oxaliplatin-related sensory neuropathy. Several pharmacological and non-pharmacological therapeutic strategies have been explored to relieve peripheral neuropathic pain. Non-pharmacological interventions have been shown to be potentially beneficial for patients suffering from chemotherapy-induced neurotoxicity. The objective of this prospective study is to evaluate the effectiveness of photobiomodulation on the reduction of neuropathic pain in patients who developed painful, cumulative peripheral neuropathy that appeared under the effect of the treatment.


Eligibility Criteria:
Inclusion Criteria:

* Recent diagnosis of digestive cancer
* 12 planned cycles of oxaliplatin
* Ability to understand and willingness to sign an informed consent form before starting any study procedures
* Patient benefiting from French health insurance

Exclusion Criteria:

* History of neuropathy before the start of the study,
* Symptomatic treatment of pain (or neuropathic pain),
* Patient with a psychotic disorder,
* Patient with diabetic neuropathy,
* Patient with metastatic cancer
* Patient with renal insufficiency,
* Adults under guardianship or curatorship,
* Vulnerable people
The Effects of Melatonin Treatment on Bone, Marrow, Sleep and Blood Pressure

Melatonin protects your bones while losing fat! This was previously demonstrated by our group. The mechanisms behind these findings are still elusive, and the aim of the present study is to assess the mechanisms.

In a double-blinded randomized controlled trial 40 postmenopausal woman are randomized to receive either 10 mg melatonin or placebo nightly for three months. Changes in gene expression in marrow cells will be assessed through micro array. Markers of bone metabolism will be assessed through biochemical markers. Cardiovascular health will be measured by tonometry and 24h blood pressure.

The results of the study will contribute with important knowledge about the beneficial effects of melatonin making it an interesting supplement to known treatment regimens against osteoporosis and overweight.


Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal women between 55 and 75 years

Exclusion Criteria:

* Severely impaired renal function
* Severely impaired hepatic function
* Coagulation factors PP\<0.6
* Hypercalcemia (p-ion calcium \>1.32 nmol/l)
* Previous or present malignancies (except a treated skin cancer that is not melanoma or treated carcinoma in situ, 2 years since last therapy)
* Diseases affecting the calcium homeostasis including untreated thyroid diseases
* Regular use of medicine affecting the calcium homeostasis, including diuretics, fenemal, lithium, antiepileptica and glucosteroids
* Selective serotonin reuptake inhibitor (SSRI)-products with fluvoxamin
* Treatment with carbamazepin
* Treatment with rifampicin
* Severe malabsorption syndrome including gastric or intestinal resection
* Alcohol or drug abuse
* Smokers
Study Evaluating Effectiveness and Safety of Zimberelimab and Domvanalimab in Lung Cancer

This is a phase 2 study to evaluate zimberelimab (AB122) combined with domvanalimab (AB154) in front-line, PD-L1-high, locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC).


Eligibility Criteria:
Key Inclusion Criteria:

* Histologically confirmed, treatment naïve, locally advanced or metastatic (stage IIIB IV per AJCC version 8), squamous or non-squamous NSCLC with documented high PD L1 expression (TC ≥ 50%) as determined by the VENTANA SP263 IHC assay, as assessed by central laboratories).
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
* Must have at least 1 measurable lesion per RECIST v1.1
* Adequate organ and marrow function
* If a participant has brain or meningeal metastases, the participant must meet the following criteria:

  1. Have no evidence of progression by neurologic symptoms or signs for at least 4 weeks prior to the first dose.
  2. Participants with previously treated brain metastases may participate provided they have stable central nervous system (CNS) disease for at least 4 weeks prior to enrollment. Stable CNS disease is defined as resolution of all neurologic symptoms to baseline, having no evidence of new or enlarging brain metastases, and not requiring use of corticosteroids for CNS disease for at least 14 days prior to the start of study treatment. Participants who have had brain metastases resected or have received whole brain radiotherapy ending at least 4 weeks (or stereotactic radiotherapy ending at least 2 weeks) prior to initiation of study treatment are permitted.
  3. Carcinomatous meningitis is excluded regardless of clinical stability.

Key Exclusion Criteria:

* Presence of any tumor genomic aberration or driver mutation for which a targeted therapy is approved by local health authority and available
* Use of any live vaccines against infectious diseases within 28 days of first dose
* Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy.
* Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or prostate cancer
* Prior treatment with any anti-PD-1, anti-PD-L1 or any other antibody targeting an immune checkpoint.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.