cyrilzakka/clinical-trials huggingface dataset:
First-in-human Study of M4076 in Advanced Solid Tumors (DDRiver Solid Tumors 410)

The purpose of this study was to determine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), maximum tolerated dose (MTD) (if reached) and early signs of efficacy of M4076 monotherapy in participants with solid tumors in dose escalation (Part 1A). Once the recommended dose for expansion (RDE) was declared in Part 1A, a preliminary food effect cohort, Part 1B, will follow at the RDE determined from Part 1A.


Eligibility Criteria:
Inclusion Criteria:

* Participants with advanced solid tumors, for whom no standard of care therapy exists or for whom is not considered sufficiently effective, or who cannot tolerate standard of care
* Participants with Eastern Cooperative Oncology Group Performance status 0 or 1
* Adequate hematological, hepatic, and renal function as defined in the protocol
* Participants in Part 1B (the preliminary food effect assessment) must agree to provide paired tumor biopsies if not contraindicated for medical reasons
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Clinically significant (i.e., active) uncontrolled intercurrent illness including, but not limited to:

  1. Active infection (i.e., requiring systemic antibiotics or antifungals)
  2. Uncontrolled arterial hypertension
  3. Severe cardiac arrhythmia requiring medication
  4. Cerebral vascular accident/stroke
* Has known ataxia telangiectasia
* Participants with tumors harboring previously identified ATM mutations
* Participants with hypersensitivity to the active substance or to any of the excipients of M4076
* Other protocol defined exclusion criteria could apply
OSsIRIS Study - A Post-market Clinical Follow-up Investigation.

This is a prospective, observational, non-randomized, multicenter, international post-market clinical follow-up investigation aiming to confirm the performance and safety of the bone substitute b.Bone after implantation in patients in isolation or as a graft expander requiring bone grafting for the treatment of surgically created bone defects or bone defects/voids resulting from traumatic injury to promote healing in the pelvis, upper and lower extremities. Patients enrolled in this clinical investigation will undergo orthopaedic surgery with b.Bone as recommended by the specialist and according to orthopaedic standard procedures. Patients will be evaluated preoperatively and at different time points after the surgery according to the standard practice of the sites. The expected schedule is at month 3, month 6 and month 12. Patients who require longer follow-up and could be subjected to metalwork removal will be evaluated up to 24 months. All safety data will be collected from patient inclusion to the end of the clinical investigation.

All study visits will coincide with any of the patient's routine clinical visits, without interfering with the investigator's clinical duties.

It is planned to enroll 135-193 patients from approximately 15 EU and UK sites.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is undergoing a standard of care bone grafting with b.Bone for the treatment of surgically created bone defects or bone defects resulting from traumatic injury in the extremities and pelvis according to the approved IFU.
2. Male or female patient ≥ 18 years old.
3. Patients willing and able to attend the standard of care follow-up visits and procedures.
4. Patients who have provided consent to participate in the clinical investigation and to the processing of personal data.

Exclusion Criteria:

1. Patients with any conditions in which b.Bone is not indicated according to the contraindications defined in the IFU of b.Bone
2. Patients who are currently enrolled in another clinical investigation/study that would directly interfere with the current clinical investigation, except when the patient is participating in a purely observational study with no associated treatments.
3. Woman who is pregnant or breast-feeding.
4. Patients who, in the opinion of the Investigator, have an existing condition that could affect their ability to complete patient reported questionnaires or be compliant with the standard of care follow-up visits and examinations for the duration of the clinical investigation.
Impaired Immunity in Patients With Cancer: Influence of Cancer Stage, Chemotherapy, and Cytomegalovirus Infection

According to a survey from Department of Health in 2004, cancer has been the leading cause of death in the Taiwan area. In 2004, people died of cancer, accounting for 27.2 percent of all deaths. The major reason of the superior grade is that cancer has the ability to escape the surveillance of immune system. It is also a main issue to address in medical research.

Dendritic cells (DCs), the most potent APC, are located at sites of pathogen entry, acquire antigens from pathogens or pathogen-infected cells, and process these antigens for both class I and class II presentation. Upon antigen encounter, they termed immature DCs, undergo a maturation process, they are capable to present captured antigens to T cells. This maturation step allows DC migration to trigger adaptive immune responses. These features make DCs very good candidates for therapy against various pathological conditions including malignancies.

Therefore, two concepts in this project will be concerned: one is enhancement of T cell immunity and the other is improvement of the efficiency of DC-tumor fusion. The strategy of enhance T cell is using well-known cytokines, such as IL2, and IL7 to expand the tumor-specific CD4 and CD8 T cells before DC-vaccine treatment. In the past, scientists utilized polyethyleneglycol to fuse cancer cells and dendritic cells. However, the results were devastating. Two new approaches of the DC vaccine will be applied to this study: DC-tumor fusion and DC phagocytosed apoptosed tumor cells. Whole tumor cells will be fused with DCs by combining hypotonic buffer and electrical-based fusion protocols. The safety of hybrid cell vaccination has been shown in clinical trials with some encouraging anti-tumour effects. However, data are as yet insufficient to assess a clear therapeutic benefit. Hopefully, the combination of two strategies will improve the efficiency of DC vaccine and boost survival of cancer patients.

As we have gained a clearer understanding of the cellular and molecular events that modulate antigen presentation and T cell activation in vivo, new strategies have emerged, allowing the development of more potent second generation DC vaccines.


Eligibility Criteria:
Inclusion Criteria:

* For observational study: health volunteers and cancer patients
* For DC vaccine: patients with solid tumor

Exclusion Criteria:

* leukemia
Application of Warm Water and Warm Salt Water to Patients With Rheumatoid Arthritis

This pretest-posttest randomized controlled study aimed to determine the effect of warm salt water and warm water bath applied to the hands and feet on pain, fatigue, sleep quality, and functional capacity in patients with rheumatoid arthritis.

The study consisted of three groups. These groups consisted of two intervention groups and one control group. As a result of the power analysis, it was determined that 54 people should be reached. Visual Analog Scale, Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire, Pittsburgh Sleep Quality Index, and Health Assessment Questionnaire were used in the study. Patients in intervention groups applied a 41°C warm salt and warm water bath three times a week for six weeks in line with the training given. The patients in the control group did not undergo any intervention other than routine treatment and care.

The study was conducted at Gulhane Training and Research Hospital Rheumatology Polyclinic, in Turkey. The sample of the study consisted of 54 patients. Eighteen patients in the warm saltwater group were trained using the video demonstration method to make the intervention. Eighteen patients in the lukewarm water group were trained using the video demonstration method to make the intervention. Eighteen patients in the control group were not given any training other than their routine treatment and care. Each patient's pain, fatigue, sleep quality, and functional capacities were measured 24 hours before the intervention. The study lasted six weeks for each patient. The patients in the intervention group performed their interventions three times a week, every other day. The patients were checked by calling every week by phone. Pain, fatigue, sleep quality, and functional capacity of each patient were measured within one week at the latest, after the end of the practices.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older,
* Followed up with a diagnosis of RA for at least 1 year,
* VAS pain score of 5 and above,
* Volunteer to participate in the research,
* Disease activity score is low-moderate (DAS28 \< 5.1),
* Patients receiving active treatment (corticosteroid, non-steroidal anti-inflammatory, disease-modifying antirheumatic drugs) for the last 3 months were included in the study.

Exclusion Criteria:

* - Comorbidity (active malignancy, heart failure or symptomatic ischemic heart disease, severe lung disease, neurologic disease that impairs mobility, uncontrolled thyroid disease, diabetes mellitus)
* Recent injury or major surgery (within 6 months prior to enrollment)
* E-joint replacement surgery is planned,
* Acute infection, fever or vascular disease in the lower and upper extremities,
* The integrity of the skin on the hands and feet is impaired,
* Participating in a regular physical therapy or exercise program,
* pregnant,
* Diagnosed with sleep apnea
* VAS pain score below 5,
* Disease activity score ≥ 5.1,
* Patients who did not agree to participate in the study were not included in the study.
Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation (POPular PAUSE TAVI)

Transcatheter aortic valve implantation (TAVI) is a rapidly growing treatment option for patients with aortic valve stenosis. Stroke is a feared complication of TAVI, with an incidence of around 4-5% in the first 30 days. Up to 50% of patients undergoing TAVI have an indication for oral anticoagulants (OAC) mostly for atrial fibrillation. OAC use during TAVI could increase bleeding complications, but interruption during TAVI may increase the risk for thromboembolic events (i.e. stroke, systemic embolism, myocardial infarction). Recent observational data suggest that periprocedural continuation of OAC is safe and might decrease the risk of stroke. Beside the potential reduction of thromboembolic events, continuation of OAC is associated with an evident clinical ancillary benefit for patients and staff. Since periprocedural OAC interruption not infrequently leads to misunderstanding and potentially dangerous situations, when patients are not properly informed before hospital admission or may experience difficulties with the interruption regimen.

Hypothesis:

Periprocedural continuation of oral anticoagulants is safe and might decrease thromboembolic complications without an increase in bleeding complications at 30 days


Eligibility Criteria:
Inclusion Criteria:

* Planned transfemoral or transsubclavian transcatheter aortic valve implantation procedure
* Uses oral anticoagulation at screening
* Provided written informed consent

Exclusion Criteria:

Patients at high risk for thromboembolism for whom interruption of oral anticoagulants is no option, i.e.:

* Mechanical heart valve prosthesis
* Intracardiac thrombus
* \< 3 months after venous thromboembolism
* \< 6 months after transient ischemic attack or stroke in patients with atrial fibrillation
Live Stream of Prehospital Emergency Ultrasound in Patients with Acute Dyspnoea

Background: Acute dyspnoea is a common symptom in prehospital emergency medicine. As ultrasound gained in importance for diagnosis in patients with acute respiratory distress, it plays even a role in the prehospital setting. However, prehospital emergency ultrasound (PEU) remains challenging and requires knowledge and skills. New prehospital ultrasound devices offer the possibility for tele-supervision. The impact of tele-supervision of PEU in patients with acute dyspnoea is unclear.

Objective: This prospective observational study aims to evaluate the effect of PEU with tele-supervision on diagnosis, treatment strategies and cognitive load in comparison to PEU without tele-supervision in patients with acute dyspnoea.

Methods: In total 350 prehospital emergency patients with acute dyspnoea will be included in this study. Patients will be observed in two groups. In group 1 PEU will be performed with tele-supervision, whereas in group 2 PEU will be performed without tele-supervision (tele-supervision not available).


Eligibility Criteria:
Inclusion Criteria:

Patients will be included, if they suffer from acute dyspnoea and at least one of the two following signs of respiratory failure:

* Respiratory rate \>20 breaths per minute
* Peripheral oxygen saturation without oxygen supplementation \<90%

Exclusion Criteria:

* under the age of 18
* if PEU will lead to a delay of live-saving treatment or transportation
* if patient rejects the PEU, the patient will be excluded
Autologous Multipotent Mesenchymal Stromal Cells in the Treatment of Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis (ALS) is a progressive neurodegenerative disease that targets motor neurons. Prognosis is invariably fatal within 3-5 years since manifestation of the disease. Despite improved understanding of the mechanisms underlying ALS, the treatment remains essentially only supportive and focused on symptoms relief. Over the past few years, stem cell research has expanded greatly as a tool for developing new therapies to treat incurable diseases. Stem cell therapy has been shown as promising in several animal ALS models and human clinical trials.

Subjects will be assigned to autologous mesenchymal stromal cell (AMSC) treatment according to inclusion and exclusion criteria (see below) screened four times prior to administration. Then the subjects will be observed for three consecutive yearsAfter a half year of screening period, the autologous multipotent mesenchymal stromal cells from bone marrow will be isolated. The cells will be cultivated for 3 passages (3 - 4 weeks) in order to get sufficient amount for therapy, cell suspension for intrathecal application will be prepared and introduced intrathecally through lumbar puncture. Subsequently, all the subjects will be observed at the range of standard medical care used at these types of interventions.

Eligibility Criteria:
Inclusion Criteria:

1. established diagnosis of definite ALS according to El Escorial criteria
2. riluzole naive or stable dose for at least 2 months,
3. life expectancy more than 2 years
4. patients able to provide written informed consent.

Exclusion Criteria:

1. FVC less than 70%
2. in case of primary bulbar paralysis less than 15 points on Norris bulbar scale,
3. less than 15 points on Norris spinal scale,
4. pregnancy, breastfeeding
5. coagulopathy,
6. skin infection at the site of bone marrow aspiration or application of the cell product,
7. gastrostomy,
8. any significant medical condition that would compromise the safety of the patient (e.g. recent myocardial infarction, congestive heart failure, renal failure, liver failure, cancer, systemic infection, recurrent thromboembolic disease .....),
9. alcohol or drug abuse
10. cancer.
11. women of childbearing potential not using effective contraception (established oral contraception, intrauterine device, ligation of the uterine tube) including proven contraceptive measures taken by their sexual partners
12. fertile men not using proven contraceptive measures including effective contraception of their partner (established oral contraception, intrauterine device, ligation of the uterine tube)
Inpatient Single Dose Interventions for Alcohol Use Disorder

Every year, alcohol use disorder (AUD) generates millions of emergency department (ED) visits and hospital admissions, costing the U.S. health sector over $90 billion. These hospital admissions are critical opportunities to start patients on addiction pharmacotherapy, but factors like medication non-adherence and post-discharge relapse contribute to frequent re-admissions. Two single-dose interventions are well suited to facilitate treatment retention and prevent re-admissions due to their prolonged, adherence-independent effects: extended-release (XR) naltrexone injection and intravenous (IV) ketamine infusion. These have not been thoroughly investigated in the hospital setting among high-utilizer, safety-net populations. Therefore, the investigators aim to:

1. Test the feasibility of randomizing hospitalized patients (n=45-60, age 18-65) with multiple AUD-related admissions to treatment with either extended-release (XR) naltrexone, intravenous (IV) ketamine, or no single-dose medication, all with enhanced linkage to care. Feasibility outcomes such as recruitment rate, patient acceptability, post-discharge follow-up rate, and adverse events will help to identify key lessons for a future comparative effectiveness study.
2. Estimate the 30-day re-admission rate for patients randomized to treatment with XR naltrexone, with IV ketamine, or no single-dose medication, all with enhanced linkage to care. The investigators hypothesize that the re-admission rate will be lower for each of the two single-dose medication groups than for the "linkage-alone" group.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* 1+ alcohol-related\* admission(s) or emergency department visit(s) in past 12 mo.
* Has insurance (public or private)
* Seen by inpatient addiction consult service

Exclusion Criteria:

* Known or suspected active COVID-19 infection
* Hepatic: AST/ALT \>5x upper-limit of normal, decompensated liver failure
* Renal: Glomerular filtration rate \<30ml/min
* Cardiovascular: History of acute coronary syndrome, cerebrovascular event, hypertensive crisis, known cardiomyopathy
* Known elevated intracranial pressure
* Thrombocytopenia (\<50/microliter)
* Active moderate/severe withdrawal (based on hospital withdrawal protocol)
* Active delirium (alcohol-related or otherwise)
* Already enrolled in study
* XR naltrexone or IV ketamine in last 30 days
* Known intolerance to naltrexone or ketamine
* Other active severe substance use disorder (tobacco, cannabis excluded)
* Pregnant or breast-feeding, or planning.
* Opioids: chronic, recent (\<24h), or anticipated
* Unstable psychiatric illness (active psychosis, active suicidality)
* Moving from region within 30-days of discharge
* Discharge to acute/residential treatment
* Involuntary hold
Identification of Risk Phenotypes for Sarcopenia Using DXA WBC, Anthropometric and MA Among Young Adults

This cross-sectional study aims to identify risk phenotypes for sarcopenia among young adults using Dual-energy X-ray Absorptiometry (DXA) for whole-body composition analysis, along with anthropometric and musculoskeletal assessments. Sarcopenia, characterized by the loss of muscle mass and strength, is a growing concern, particularly among the aging population.

However, early identification in young adults can allow for preventive strategies to improve long-term health outcomes. This study, involving 221 participants aged 15 to 35, focuses on assessing the correlation between DXA-derived body composition, musculoskeletal fitness, and anthropometric measurements with sarcopenia risk. Primary outcome measures include DXA imaging and dynamometry for body composition and strength evaluation, while secondary outcomes focus on detailed anthropometric and musculoskeletal analyses. By addressing early risk factors in younger populations, this research hopes to enhance understanding of sarcopenia's development and support early intervention strategies. Data collection is conducted at the Center of Nuclear Medicine in Lahore, Pakistan.

Eligibility Criteria:
Inclusion Criteria:

* Young Adults ( between 15-35) (7)

Exclusion Criteria:

* Elderly Patients
* Children below the age of 18 Years
* Diagnosed Malignancy
* Diagnosed Patients
* Diseased Individuals such as Chronic Illness and Malignancies
Cognitive Training to Improve Cognitive Function Following Chemotherapy

The purpose of this study is to improve cognitive dysfunction following chemotherapy, the investigators investigated to see whether a cognitive training for memory and concentration skills can improve cognitive performance in patients following cancer treatment.

Patients following chemotherapy invited for a cognitive training. Before and after cognitive function will evaluate.

Eligibility Criteria:
Inclusion Criteria:

* patients with cancer 6 weeks after chemotherapy

Exclusion Criteria:

* patients with neurological or psychiatric disorders
* patients without compliance
PK of MMF in Cadaveric vs Living Donor Liver Transplant Recipients

The purpose of this study is to measure the amount of MMF and tacrolimus concentration in the blood at a given time. Currently MMF is ordered as a set dose and tacrolimus is given based on body weight. While the deceased donor transplant receives the complete liver, in the live donor just over half of the liver is given (about 60%). The way these different types of transplants break down drugs could be different. Measuring the drug levels allows us to know what happens to the medication in between the morning and the evening dose.

The purpose of this study is to measure the amount of MMF and tacrolimus concentration in the blood at a given time. Currently MMF is ordered as a set dose and tacrolimus is given based on body weight. While the deceased donor transplant receives the complete liver, in the live donor just over half of the liver is given (about 60%). The way these different types of transplants break down drugs could be different. Measuring the drug levels allows us to know what happens to the medication in between the morning and the evening dose.

12 subjects with live liver donors and 12 subjects with deceased donors will be included in the study.

Each patient will have 12 (twelve) blood samples (half a teaspoon) drawn at 0,1, 2, 3, 4, 4½; 5, 6, 7, 8, 10 and 12 hours from an intravenous line placed during the operation. At the same time, 24-hour urine will be collected to measure your kidney function. After 4 to 6 days post transplant when the will be switched to oral MMF, again 10 (ten) blood samples a half teaspoon each will be drawn at 0, 1, 2, 3, 4, 5, 6, 8, 10, 12 hours. Blood will be drawn with the routine daily blood work for the first 14 days and then at 1 and 3 months after transplant. Total blood drawn over 3 months will be about 7 tablespoons. A 24-hour urine will be collected in a container given to you starting one day before the routine clinic visit (as a standard of care). The 24-hour urine will be collected at 1 and 3 months after transplant as well.

If a woman, who could become pregnant, a pregnancy test will be done before your transplant. They would also have to use birth control during the study period and 6 months after the completion of study.

Eligibility Criteria:
Inclusion Criteria:

* Adult
* Female patients
* Negative pregnancy test
* Willing for contraception during the study period and 6 weeks after study

Exclusion Criteria:

* Serum Creatinine \> 2.5 mg/dl
* On Dialysis
* HIV +ve
* Re-transplantation
* On Ventilator
* Multi-organ Transplant
* Platelets \< 50,000
* WBC \< 2,500
A Comparative Study Between PF-06410293 and Humira® in Combination With Methotrexate in Participants With Active Rheumatoid Arthritis

The study will assess the impact of pharmacokinetics (PK), safety and immunogenicity after switches between PF-06410293 and adalimumab and with continuous dosing with adalimumab in combination with methotrexate in subjects with moderately to severely active rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of RA based on 2010 ACR/EULAR for RA for at least a 4 month duration.
* Moderately to severely active RA based on local standard of care.

Exclusion Criteria:

-Evidence of untreated or inadequately treated latent or active TB.