cyrilzakka/clinical-trials huggingface dataset:
Multi-Center Molecular Diagnosis and Host Response of Respiratory Viral Infections in Pediatric Transplant Recipients

The participants are being asked to take part in this clinical trial, a type of research study, because the participants are scheduled to receive or have recently received a hematopoietic cell transplant (HCT) or a solid organ transplant (SOT).

Primary Objective

To determine if pre-transplant screening for respiratory viral load predicts RVI within 1- year post-transplant among survivors.

Secondary Objectives:

* To develop and validate a classifier based on pre-transplant immunological profile predictive of developing an acute respiratory viral infection (aRVI), with RSV/PIV3/HMPV/SARS-CoV-2 through one-year post-transplant among survivors.
* To develop and validate a classifier based on Day +100 post-transplant immunological profiles predictive of developing an acute respiratory viral infection (aRVI),with RSV/PIV3/HMPV/SARS-CoV-2 through one-year post-transplant among survivors .

The investigators will collect a nasal swab and blood sample from the participant when the participant is enrolled on the study and if the participant develops a RVI in the first year after transplant. The investigators will collect a blood sample 100 days after the participant's transplant.

Eligibility Criteria:
Recipient Inclusion Criteria

* Less than 18 years at the time of anticipated transplant
* Participant meets one of the following criteria:

  1. scheduled to receive allogeneic hematopoietic cell transplant within 14 days of enrollment or
  2. Scheduled to or received solid organ transplant within 7 days before or after enrollment
* Participant is receiving care at the time of enrollment at one of the study participating institutions.
* Parent/guardian willing and able to provide informed consent, and if appropriate, child willing and able to provide informed assent.

Donor Inclusion Criteria

* Donor for HCT recipient enrolled on the VIPER study.
* Willing and able to provide informed consent.

Exclusion Criteria:

Recipient Exclusion Criteria

None

Donor Exclusion Criteria

* Is not an HCT donor for a participant enrolled on the VIPER study.
* Not available to provide pre-transplant research blood sample.
"All Comers" Post Market Clinical Follow-up (PMCF) With Multi-LOC for flOw liMiting Outcomes (LOCOMOTIVE Extended)

The aim of the study is to assess the safety and efficacy of the Multi-LOC® peripheral stent system to treat de novo and restenotic lesions (no in-stent restenosis (ISR), no restenosis post drug coated balloon (DCB) after flow limiting plain old balloon angioplasty (POBA) and/or DCB dilatations in the superficial femoral artery (SFA) and popliteal segments (P1, P2 \& P3)

This study is an non-randomized, prospective, multi-center, non-interventional study (registry, for Germany: §23b MPG)

Eligibility Criteria:
Inclusion Criteria:

* Willingness to treat flow-limiting dissections/recoil after plain old balloon angioplasty (POBA)/drug coated balloon (DCB) interventions
* Patients in Rutherford classes 2 through 5
* Patients eligible for peripheral revascularization by means of percutaneous transluminal angioplasty (PTA) and stenting
* Patients must be at least 18 years of age
* Patient with a life expectance of at least 12 months
* Patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in the following study protocol
* Patients must agree to undergo at least the 6-month clinical follow-up
* Patient is able to verbally acknowledge an understanding of the associated risks, benefits, and treatment alternatives to therapeutic options of this trial, e.g. balloon angioplasty by means of other suitable stent devices. Patients, by providing their informed consent, agree to these risks and benefits as stated in the patient informed consent document.
* Lesions with unsatisfying angiographic results due to recoil and/or dissections after POBA/DCB interventions
* Infra-inguinal lesions in the superficial femoral artery (SFA) and popliteal segments (P1,P2 \& P3) reference vessel diameters between 4 and 7.0 mm, lesion length suitable for the release of at least 2 Stent (up to 6) segments implanted with a minimum inter-stent distance of 1 cm
* Diameter stenosis pre-procedure must be larger or equal to 70%
* Vessels must have adequate distal run-off with at least one vessel to the foot or with collaterals in the calf supplying sufficient flow to the foot.

(Lesions separated by less than 2 cm are considered as one lesion)

Exclusion Criteria:

* Patient not suitable for revascularization by interventional means
Safety Study of a Vaccine Against Meningitis in Infants (2,4 & 6 Months Age) After a Birth Dose of Hepatitis B.

The purpose of this study is to compare the reactogenicity \& safety of Tritanrix™-HepB/Hib-MenAC vaccine to the international standard of care, Tritanrix™-HepB/Hiberix™.

Randomized study with four groups to receive one of the following vaccination regimens after a dose of hepatitis B vaccine given at birth:

* One of the 3 lots of GSK Biologicals' Hib-MenAC mixed with GSK Biologicals' Tritanrix™-HepB (3 different groups)
* GSK Biologicals' Tritanrix™-HepB/Hiberix™

Eligibility Criteria:
Inclusion criteria:

• Healthy infants 56-83 days of age at the time of the first vaccine dose, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks \& has received a birth dose of hepatitis B vaccine within the first 3 days of life.

Exclusion criteria:

* Any confirmed immunodeficient condition, based on medical history and physical examination.
* Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of study vaccine, or planned administration during the study period with the exception of oral polio vaccine (OPV).
* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
* Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
* Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, and/or meningococcal disease.
* History of diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or meningococcal disease or known exposure to these diseases since birth.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Comparison of Operated Ruptured and Non-ruptured Endometriomas

Ruptured endometrioma cases were compared with unruptured endometrioma cases.

This study aims to compare the findings in patients who had surgery for ruptured endometrioma with the patients who had an unruptured endometrioma.

This study was conducted at Republic of Turkey Ministry of Health, Health Science University Etlik Zübeyde Hanım Gynecology Training and Research Hospital Infertility Clinic and all patients who were operated for endometrioma and had a histopathology report confirming the presence of endometrioma between January 2014 and December 2020 were included.

In this study, demographic characteristics, intraoperative findings, laboratory values and follow-up recommendations of two groups compared. The patients' age, presence of sexual activity and/or infertility, gravidity, parity, abortion, history of ectopic pregnancy, accompanying systemic disease, previous operations, drug use, and symptoms were recorded. Preoperative and postoperative complete blood count, Cancer antigen 125 (CA 125), Cancer antigen 19-9 (CA19-9), Cancer antigen 15-3 (CA 15-3), Carcinoembryonic antigen (CEA), alpha fetoprotein (AFP), anti mullerian hormone (AMH), fibrinogen, C-reactive protein (CRP) values of the patients were obtained. Patient files, operation notes and laboratory values of the electronic recording system database and the two groups were compared.

Eligibility Criteria:
Inclusion Criteria:

* All patients who were operated on in Republic of Turkey Ministry of Health, Health Science University Etlik Zübeyde Hanım Gynecology Training and Research Hospital Infertility Clinic, whose histopathological diagnosis was confirmed as endometrioma, and who did not meet the exclusion criteria, were included in the study.

Exclusion Criteria:

* Patients who were operated with a prediagnosis of endometrioma and whose pathological diagnosis was different
* Patients with smoking, alcohol, substance abuse
* Patients receiving pelvic radiotherapy/chemotherapy
* Patients with suspected or confirmed malignancies
A Study of IMC-001 on Improved Atherosclerotic Plaque Stability in Patients of ACS

This study is an IIT clinical study to evaluate the efficacy and safety of IMC-001 for injection on improved atherosclerotic plaque stability in patients receiving optimal medical therapy after a recent acute coronary syndrome (ACS). The study was a single-center, simple randomized, controlled study, in which the experimental group was given IMC-001 and the best drug treatment, and 8 subjects were included, and the control group was given only the best drug treatment, and 6 subjects were included.


Eligibility Criteria:
Inclusion Criteria:

1. Aged between 18 and 75 years old, male or female;
2. Patients with recent (within 30 days prior to enrollment) who have had acute coronary syndrome;
3. CTA examination of the presence of at least one measurable target vessel segment in the coronary artery, and the following two conditions must be met at the same time: the total volume of plaques with calcified volume accounting for \<50%, and the presence of low-density attenuated plaques (LAP) that meet the definition of CTA;
4. Subjects understand and comply with the study procedures, participate voluntarily, and sign the informed consent form.

Exclusion Criteria:

Subjects who meet any of the following criteria cannot enter this study:

1. CTA shows complete occlusion of any section of blood vessel.
2. Those who have had cerebral infarction or TIA in the past 12 months.
3. Myocardial infarction within the past 12 months.
4. Patients who have received CABG, heart transplantation, SAVR/TAVR, etc. (patients who have undergone PCI in the past can be included); or patients who plan to undergo treatment such as CABG, PCI, heart transplantation, SAVR/TAVR, etc. during the study.
5. Recurrent episodes, severe symptoms, and cardiac arrhythmias that do not respond to drug therapy within the past 3 months, such as ventricular tachycardia, atrial fibrillation with rapid ventricular rate, and paroxysmal supraventricular tachycardia.
6. Subjects who, in the opinion of the investigator, are not suitable to participate in the study.
Study of VAY736 as Single Agent and in Combination With Select Antineoplastic Agents in Patients With Non-Hodgkin Lymphoma

The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), immunogenicity and preliminary efficacy of VAY736 alone or in combination with other therapies in patients with NHL in a platform trial.

The primary objective of the study is to evaluate the safety and tolerability in patients with NHL and identify a maximum tolerated dose (MTD) and/or recommended dose (RD) of VAY736 single agent and in combination with other anti-cancer therapies.

This is a phase I/Ib, multi-center, open-label study with multiple treatment arms in an adaptive study design. The study is comprised of a dose escalation part and dose expansion part.

In dose escalation, the investigational drug VAY736 was explored alone or in combination with lenalidomide. Increasing doses of VAY736 alone or in combination were given to small groups of patients to identify the maximum tolerated dose/recommended dose (MTD/RD) in patients with NHL. In dose expansion, some or all the treatments from dose escalation could be tested at the recommended doses in patients with NHL. The study was expected to last approximately 4 years (from the enrollment of the first patient to the discontinuation of the last patient), but it was terminated early due to a business decision, not because of any safety or tolerability concerns. Consequently, the dose expansion part was not conducted.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with confirmed diagnosis of relapsed/refractory B-cell NHL with all subtypes of DLBCL, follicular lymphoma (FL), marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL) per WHO 2016 criteria. Patients in subtype arm e.g. DLBCL must have confirmed diagnosis of relapsed/refractory DLBCL.
* Received and failed or be intolerant to standard of care therapy (at least two prior lines, including an anti-CD20 therapy for NHL)
* Must have measurable disease and ECOG of 0 to 2

Exclusion Criteria:

* Baseline laboratory results outside of protocol defined ranges
* Patients with primary CNS lymphoma
* History of hypersensitivity to VAY736 or any drugs in similar chemical classes (e.g. monoclonal antibodies)
* Impaired cardiac function or clinically significant cardiac disease
* History of or current interstitial lung disease or pneumonitis grade 2 or higher
* HIV infection
* Active hepatitis C infection and/or hepatitis B infection
* Pregnant or nursing (lactating) women
* Women of child-bearing potential unless they are using highly effective methods of contraception

Other Inclusion/Exclusion criteria may apply
Peripheral Magnetic Stimulation (PMS) Effects on Somatosensory Perception in Patients with Upper Limb Amputation

The study investigates the capabilities of peripheral magnetic stimulation (PMS) as a tool for creating somatosensory sensations of various submodalities and analyzing the dynamics of bioelectric signals of the brain (using encephalography (EEG)) in healthy participants and participants with upper limb amputations. During the experiment, the participants' subjective sensations and EEG activity are recorded in response to magnetic pulses of varying intensity. In addition, the continuous PMS stimulation protocol and its effect on phantom sensations in participants with amputations will be tested for subsequent implementation in clinical practice.


Eligibility Criteria:
For Healthy Volunteers:

Inclusion Criteria:

1. Availability of signed written informed consent.
2. Absence of somatic and psychiatric diseases (more details in the exclusion criteria)
3. Ability and willingness to comply with the requirements of this protocol. Inclusion Criteria

Exclusion Criteria:

1. History of epilepsy (participant, participant's close relatives)
2. Presence of metal or/and electric stimulators and/or implants in participant's body
3. Presence of psychiatric disorders (including a history of), severe depression, suicidal tendencies, or a history of suicide attempts.
4. History of cancer.
5. Complicated traumatic brain injury (TBI) or a history of stroke.
6. Drug addiction (including a history of).
7. Congenital anomaly of upper limb development.
8. Anomalies in the development of the central and peripheral nervous systems.
9. Pregnancy

For stroke patients:

1. History of epilepsy (participant, participant's close relatives)
2. Presence of metal or/and electric stimulators and/or implants in participant's body
3. Presence of psychiatric disorders (including a history of), severe depression, suicidal tendencies, or a history of suicide attempts.
4. History of cancer.
5. Complicated traumatic brain injury (TBI) or a history of stroke.
6. Drug addiction (including a history of).
7. Congenital anomaly of upper limb development.
8. Anomalies in the development of the central and peripheral nervous systems.
9. Pregnancy
10. Presence of severe somatic pathology
11. Presence of severe orthopedic deformity in the limb above the level of amputation.
12. Purulent-septic pathology.
AssesSment of Early-deteCtion basEd oN liquiD Biopsy in Hepatobiliary Cancer Malignancies

This study is a prospective, multicenter study aimed to develop and validate the performance of combined assays for cfDNA methylation markers and serum tumor markers in early hepatobiliary malignancies detection. Circulating tumor DNA (ctDNA) mutation, blood RNA markers and tissue will also be evaluated. The study will enroll approximately 496 participants, including participants with malignant or benign diseases of the hepatobiliary system.


Eligibility Criteria:
Inclusion Criteria for All the Participants:

* 40-75 years old
* Ability to comply with study procedures
* Ability to provide a written informed consent

Exclusion Criteria for All the Participants:

* Pregnancy or lactating women
* Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant
* Recipients of blood transfusion within 7 days prior to study blood draw
* Recipients of anti-microbial therapy within 14 days prior to study blood draw
* Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancer

Inclusion Criteria for Cancer Arm Participants:

* Confirmed diagnosis or highly suspicious cases of hepatobiliary malignancies
* No prior or ongoing anti-cancer therapy (local or systematic) prior to study blood draw

Exclusion Criteria for Cancer Arm Participants:

* Current diagnosis of other malignancies or multiple primary tumors
* Diagnosis of benign diseases by histopathological assessments
* Inability to characterize whether the lesion is malignant or benign
* Prior or ongoing treatment of cancer

Inclusion Criteria for Benign Diseases Arm Participants:

* Confirmed diagnosis of benign diseases of the hepatobiliary system
* No prior radical treatment of the benign diseases prior to study blood draw

Exclusion Criteria for Benign Diseases Arm Participants:

* Current or history of malignancies or precancerous lesions
* No confirmed diagnosis or inability to characterize a benign disease
The Effect of Single Task vs. Dual Task Assessment in Individuals With Knee Osteoarthritis

Osteoarthritis is characterized by progressive degeneration of articular cartilage, weakening of subchondral bone, synovial inflammation, meniscal degeneration, and intra-articular osteophytes.

Dual tasking is when two tasks can be done simultaneously. A dual task may involve two different simultaneous motor tasks, or it may include a cognitive task in addition to the motor task. Following the additional task given, there may be a decrease in the performance of the main task or in the performance of both tasks.

Decreased balance control can lead to fall injuries that result in serious physical, psychological and social losses. Before the management of this condition, an effective evaluation of balance control in patients with knee osteoarthritis is required.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 40-65
* A diagnosis of knee osteoarthritis in at least one of the knees clinically and radiographically according to the criteria of the American Society of Rheumatology
* Findings consistent with stage II-III osteoarthritis
* Pain is between 2 and 7 according to the visual analog scale.

Exclusion Criteria:

* Acute osteoarthritis in the knee
* Comorbid diseases (advanced osteoporosis, vertigo, neurological diseases, etc.), injuries and surgeries for which exercise is contraindicated
* NSAID and similar disease-modifying drug use (Diaserein, Glucosamine, etc.)
* Having exercised regularly in the last 6 months (more than 1 day per week)
* Having undergone arthroplasty surgery
* Intra-articular injection (hyaluronic acid/steroid) administration in the last 6 months
Prospective Evaluation of Predictors for Organ Failure Following Liver Transplantation

Early organ failure occurs frequently and is difficult to predict. The study aims to define a predictive score for early transplant failure.

Patients will be monitored 7 days following liver transplantation, including clinical scores, clinical chemistry, ultrasound findings and indocyaninegreen-clearance.

Eligibility Criteria:
Inclusion Criteria:

* orthotopic liver transplantation
* age \> 18 years

Exclusion Criteria:

* allergy to indocyangreen
Hematotoxicity in Maintenance Therapy of Children With Acute Lymphoblastic Leukemia

Subjects who are recruited in this study are LLA patient, who are treated for routine control to Cipto Mangunkusumo Hospital, who meet the inclusion criteria and do not meet the exclusion criteria.

On the day of the control patient, (usually the patient is asked for routine control at week 3 on mercaptopurin) routine blood tests are performed. Patients and parents were given an explanation of this study. If patients and parents are willing to take part in the study, they are asked to sign informed consent. Patients who meet the inclusion criteria and do not meet the exclusion criteria, are recorded for demographic data and 5 ml of blood taking. The blood is directly divided into three, 2 mL for hematologic examination and albumin level, 1 mL for genotyping, and 2 mL for examination of drug levels. Routine hematologic examination and albumin levels were performed in the Cipto Mangunkusumo hospital laboratory. For genotypic examination, blood samples were stored at -80C, until they were used for analysis. For examination of the drug levels the blood sample is centrifuged and the erythrocyte preparation is then stored at -80C, until it is used for analysis.

Eligibility Criteria:
Inclusion Criteria:

* Acute lymphoblastic leukemia (ALL) patients, 1 until 18 years old, male or female, who come to Cipto Mangunkusumo Hospital, Jakarta, Indonesia
* Received 6MP chemotherapy at least 1 month maintenance phase
* Received maintenance phase treatment regimen
* Willing to participate in research, signed informed consent and obtained parental consent to participate in research

Exclusion Criteria:

* Patients are experiencing severe infections
* Patients receiving colony stimulating factor (CSF), allopurinol, mesalazine, olsalazine, and sulfasalazine
Starvation in the Treatment of Diabetic Ketoacidosis

Diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state (HHS) are common, but serious metabolic disorders are often encountered in intensive care. In the intensive care setting, it is common to withhold food from patients during treatment of DKA. However, there is no evidence or current literature supporting this practice. The following proposed research investigates the initiation of an early diet versus withholding food during the treatment of diabetic ketoacidosis.


Eligibility Criteria:
Inclusion Criteria:

* Males and females with the diagnosis of diabetic ketoacidosis (defined as blood glucose greater than 250 mg/dL, arterial pH less than 7.3, serum bicarbonate less than 15 mEq/L, and the presence of ketonemia or ketonuria)
* Age between 18-89
* Admission to the Medical Intensive Care Unit
* Able to provide informed consent

Exclusion Criteria:

* Pregnant and breast-feeding women
* Institutionalized patients or prisoners
* Patients unable to eat by mouth, including intubation, presence of any tube used for enteral feeding (nasogastric tube, orogastric tube, PEG tube, etc.), medical conditions requiring parenteral feeding, and a history of a medical condition that prevented oral intake prior to admission, including achalasia, esophageal cancer, stroke with residual deficits preventing oral intake, amyotrophic lateral sclerosis, or head and neck trauma.