cyrilzakka/clinical-trials huggingface dataset:
Tricaprilin Liquid Formulation PK Study

The purpose of this study is to evaluate the pharmacokinetics, safety, and tolerability of new liquid formulations of tricaprilin, with the aim of finding a suitable formulation to advance in development. This is a three-part, part-randomised study that include single-dose, food effect, and titration tolerability in up to 80 healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
* Participants who are overtly healthy (in the opinion of the Investigator) as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
* Body weight ≥45 kg and body mass index (BMI) within the range 18.0 - 32.0 kg/m2 (inclusive).
* Male and female
* Agrees to comply with study procedures including blood draws, confinement to clinic, meal requirements
* Continuous non-smoker or infrequent smoker (no more than 10 cigarettes per week for at least 3 months prior to Screening)

Exclusion Criteria:

* History of, or current gastrointestinal (GI) conditions constituting a risk when taking the study treatment; or interfering with the interpretation of data, based on the Investigator's judgement
* Past or intended use of over-the-counter or prescription medication including herbal medications within 7 days prior to dosing (paracetamol/acetaminophen \[up to 2 g per day\], hormone replacement therapy and hormonal contraception are permitted).
* Participants on a ketogenic diet, low-fat diet or actively using medium chain triglycerides, ketone esters, or other ketogenic products.
Intensive Monitoring and Preemptive Intervention in the Maintenance of AVF

Whether intensive monitoring and preemptive intervention has an positive clinical effect on arterio-venous fistula (AVF) maintenance is a new issue in hemodialysis (HD) patient management. This study aims to explore the clinical value of intensive monitoring and preemptive intervention on AVF, so to decide the best follow-up items and frequency.


Eligibility Criteria:
Inclusion Criteria:

* patients on HD with AVF in Zhongshan Hospital, Fudan University

Exclusion Criteria:

* with malignancies
Clinical Trial of Dipyridamole in Schizophrenia

This is a 6-week, randomized, double blind, parallel groups designed, olanzapine-controlled trial of oral dipyridamole in symptomatic patients with a (DSM IV) diagnosis of schizophrenia, schizoaffective or schizophreniform disorder. This pilot study aims to provide preliminary estimates of whether the effect sizes of dipyridamole on positive symptoms, negative symptoms, and cognitive deficits differ between schizophrenia patients treated with dipyridamole, and schizophrenia patients treated with olanzapine. A total of 30 subjects will be recruited locally.

Since the demonstrated success of chlorpromazine in treating psychosis in the1950's, the pharmacotherapy of schizophrenia has focused mainly on drugs with antidopaminergic actions. These drugs have robust effects on reality distortion and disorganization symptom complexes, but minimal effect on cognitive impairment, negative symptoms, and functional outcome and quality of life measures. Newer generation antipsychotic drugs have a similar profile of effects, with some advantages on the course of depression, hostility, suicide, hospital readmission rates and motor side effect measures. Side effects such as weight gain, increase in cardiovascular stress and diabetes risk are associated with some new generation drugs. A new class of drugs is needed to address the inadequate effectiveness and the side-effect disadvantages of the currently available pharmacological agents for the treatment of schizophrenia. Recently, new treatment strategies using nicotinergic drugs or agonists at the glycine modulatory site of the glutamatergic N-methyl-D-aspartate (NMDA) receptor have been employed in clinical trials with mixed results. Our proposal focuses on a clinically available adenosine agonist, dipyridamole, in a 6-week clinical trial. Published data suggest effectiveness of dipyridamole in treating psychosis when added to haloperidol treatment. The effectiveness of dipyridamole alone in treating schizophrenia symptoms, although indirectly suggested by several lines of evidence, has not been tested.

Eligibility Criteria:
Inclusion Criteria:

* Subjects between ages 18-65, both males and nonpregnant females (on birth control) Diagnosis of schizophrenia, schizoaffective or schizophreniform disorder Ability to give written informed consent Total BPRS score \> 27 Psychosis subscale scores \> 7

Exclusion Criteria:

* Patients with coagulative disorders, bleeding diathesis or currently on anticoagulants, and patients with major medical illnesses (including hypertension, angina, and cardiovascular diseases) or an abnormal baseline ECG.

Patients with moderate to severe mental retardation.

Inability to sign informed consent.

Patients with a history of serious violence (e.g., suicide attempts, or assaultive behavior).

Patients on clozapine treatment within the 6 weeks leading to the double-blind phase.

Patients with a history of olanzapine non-response

Positive Urine Toxicology Screen
Safety of Magnetic Resonance Imaging in Non-MRI Conditional Pacemakers and ICD Devices

The primary objective of the study is to determine the safety of MRI in patients with non-MRI conditional pacemakers. The secondary objective is to determine if there are clinically relevant parameter changes in the devices.


Eligibility Criteria:
Inclusion Criteria. All patients with non-MRI conditional pacemakers and ICDs between the ages of 18-85 will be eligible to participate. Medical records will be reviewed to confirm the date and make/model of device implanted. Ordering physician discusses the MRI request with radiologist, documenting that there is no appropriate alternate imaging test. Patient must have an appointment with a cardiologist/electrophysiologist prior to MRI. Banner Health policy for standard of care guidelines involving patients receiving MRI's will be followed.

Exclusion Criteria. Patients will be excluded from MRI based on the Department of Radiology protocol. Additional exclusion criteria include: ICD and pacemaker dependent, Pacemaker inserted before 2002, Epicardial leads, fractured leads, abandoned leads, or temporary pacemakers (post-coronary artery bypass graft temporary epicardial pacing wires are acceptable), Patient not awake or unable communicate, Battery voltage at elective replacement interval, implanted non-MRI conditional device (other than pacemaker/ICD).
Autologous Bone Marrow Mononuclear Cells in Liver Cirrhosis

This is a phase I clinical study to evaluate feasibility, safety and kinetics of cellular therapy with autologous bone marrow-derived mononuclear cells (BMMC) in patients with liver cirrhosis due to virus C hepatitis. Another aim is to study liver tissue changes induced by the BMMC presence. All the patients have moderate liver disfunction and will be submitted to a liver biopsy before BMMC injection. The cells will be labeled with 99mTc and infused through a peripheral vein. Scintigraphy will be performed 24 hours after infusion.

Patients will be submitted to frequent clinical, laboratorial and image evaluation during a one-year follow-up. A second liver biopsy will be done in the 3rd month after infusion to check histological, cellular and molecular evolutive changes.


Eligibility Criteria:
Inclusion Criteria:

* Chronic virus C hepatitis
* Liver cirrhosis
* Moderate liver disfunction

Exclusion Criteria:

* Malignant disease
* Pregnancy
* Significant comorbidity
* Portal vein thrombosis
Rhinovirus Study With Lactobacillus Rhamnosus GG

The purpose of this study is to evaluate the symptom impact of probiotic Lactobacillus rhamnosus GG during rhinovirus infection.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female in general good health (stabilized chronic illnesses and regular medications are accepted, if not otherwise mentioned in the exclusion criteria)
2. Age 18-65 years
3. Serum neutralizing antibody titer of 1:4 or less for the challenge rhinovirus
4. No clinically significant finding on the pre-study nasal examination
5. Females must have a negative urine pregnancy test, and women of child-bearing potential must be using an effective method of birth control such as, but not limited to birth control pills, contraceptive foam, diaphragm, IUD, surgical sterilization, abstinence, or condoms
6. Written informed consent must be obtained at enrollment into the study

Exclusion Criteria:

1. Suffer from or have a history of significant allergic rhinitis at the time of study
2. Bronchial asthma or other lower respiratory tract diseases, such as chronic obstructive lung disease or emphysema
3. Nasal abnormalities or other nasal pathology, such as irreversible nasal mucosal hypertrophy or severe nasal septum derivation
4. Pregnancy or lactation
5. History of alcohol abuse (regularly consumes 5 or more alcohol drinks per day) and/or drug abuse during the 12 month period immediately preceding study enrollment
6. Daily smoking within the past 2 years
7. Use of investigational product or participation in a device trial during the 30 day period immediately preceding study enrollment
8. Previous participation in an experimental study with rhinovirus 39
9. Allergy to any ingredient in the study product
10. Have, as determined by the investigator and/or the sponsor's medical monitor, any surgical or medical condition or take any medication or dietary supplement that could interfere with the interpretation of study results or jeopardize the safety of the subject
Psychiatric Problems in Thalassemic Children

Aims of the study :

1. Assessment the prevalence of psychiatric problems in thalassemic children .
2. Assessment the prevalence of cognitive problems in thalassemic children .
3. Determine factors associated with psychiatric and cognitive problems in thalassemic children .

Sociodemographic information, other associated factors , CBCL (Child Behaviour Check List) and Children's Sleep Habits Questionnaire will be collected by thalassemic child's caregiver interview at Assiut university ,Children hospital , pediatric hematology unit .

Raven´s Colored Progressive Matrices will be solved by thalassemic patient at Assiut university , Children hospital , pediatric hematology unit .

Beta-thalassemia is a chronic and genetically determined hematological disorder characterized by severe hemolytic anemia as a result of deficient synthesis of β chains of hemoglobin.

β-Thalassemia major is considered the commonest hemoglobinopathy in the Mediterranean area particularly Egypt with an estimated carrier rate of 9-10.2 % . From about registered β-thalassemia cases ; 95% of them are β-thalassemia major, and 5% are thalassemia intermediate.

It demands frequent blood transfusions to maintain life, while haemosiderosis and other complications of the disease require a continuous and distressing treatment regimen that includes parenteral iron chelation treatment and regular medical supervision.

The drawbacks of the disease in many aspects of life become strongly evident during the school age when children ask for independence . It has been related with psychosocial aspect and a significant negative effect on areas of school functioning because of the likelihood of physical deformity, growth retardation and delayed puberty besides the difficulty of management (such as regular transfusion and time-consuming iron chelation treatment) Social stigma associated with having thalassaemia have significant psychosocial and emotional impact on patients and their families(3) , so The affected children become more liable to emotional, social, psychological and behavioural problems .

No available studies about psychiatric problems among thalassemic children in Egypt . Also study that were conducted in the age \&amp;lt; 12 years are few .

Eligibility Criteria:
Inclusion Criteria:

* 1. Age between 6 to \&lt; 12 years.

Exclusion Criteria:

1. Patients who had bone marrow transplant and were cured of thalassemia .
2. Neurological illness preventing them from expressing themselves and not able to communicate well
Nonmyeloablative Allo SCT for the Treatment of Hematologic Disorders

The purpose of this study is to provide allogeneic stem cell transplantation to patients who have not traditionally undergone this procedure because of it high incidence of treatment related side effects. We hope to decrease these side effects by decreasing the chemotherapy dose prior to transplant (non-myeloablative, smaller dose of chemotherapy given so bone marrow is not completely eliminated) and by using donated stem cells to treat cancer of the blood.


Eligibility Criteria:
Inclusion Criteria - Patient:

* AML, ALL,CML Chronic Phase, Accelerated Phase, or Blast Crisis, CLL, MDS, RELAPSED NON-HODGKIN'S OR HODGKIN'S LYMPHOMA, Aplastic Anemia, Multiple Myeloma, MYELOPROLIFERATIVE DISORDER (P Vera, CMML, ET
* Age less than 65 years
* Patients must have a healthy family member who is HLA-identical to the recipient or has 1 antigen mismatch and who is willing to receive a course of G-CSF and undergo 2-4 daily leukaphereses
* Each patient must sign an informed consent and be willing to participate as a research subject after having been advised of the nature and risk of the study prior to entering protocol

Inclusion Criteria - Donor:

* Absence of hematologic or marrow function related diseases that interferes with the collection of sufficient numbers of normal progenitor cells
* Absence of any medical condition that would pose a serious health risk by undergoing peripheral blood stem cell harvest
* Negative HIV, HTLV-1, Hepatitis B surface antigen and Hepatitis C
* The donor must be blood relation. A prospective related donor must be at least genotypically HLA-A, B, DR identical to the patient, but can differ for 1 HLA-locus.

Exclusion Criteria - Patient:

* Active CNS involvement
* Females who are pregnant or breast feeding
* ECOG performance status \> 1. Karnofsky performance status \< 80%
* LVEF \< 40%
* Active viral, bacterial, or fungal infection
* Patients seropositive for HIV; HTLV -1
* Patients not providing informed consent
* Patients with known hypersensitivity to E. Coli derived product

Exclusion Criteria - Donor:

* A positive HIv infection or HTLV - 1 test or evidence of active/persistent viral hepatitis infection. Presence of any medical condition that would pose a serious health risk by undergoing peripheral blood stem cell harvest. Donors with known hypersensitivity to E. Coli derived products.
First Aid by Laypersons - Effect on Mortality and Length of Stay

The study aims to assess the effect of first aid from bystanders on survival, admission length, and need of ICU-stay for trauma victims.

All ambulance services in Norway will be invited to participate. In the participating ambulance services, the personnel of first unit to reach the scene of accident for any emergency response to trauma will register what first aid measures (if any) are indicated and have been performed by the bystanders on the scene up til the point where the ambulance arrives. Hospital data for each case will be retrieved. Those patients who did receive correct first aid will then be compared to those patients who did not receive first aid, and those where first aid was attempted but not correct for differences in share of survivors, length of hospital stay, and need for admission to ICU.

Eligibility Criteria:
Inclusion Criteria:

* All emergency response calls to trauma (drownings and hangings included)

Exclusion Criteria:

* No injury to patient
* Non-traumatic condition
* Poisonings
Fibtem Predicts Postoperative Bleeding

Retrospective study to evaluate if FIBTEM predicts the amount of postoperative bleeding in total knee replacement patients.

This retrospective study evaluate patients who underwent total knee replacement arthroplasty. Laboratory coagulation parameters, including FIBTEM, before anesthesia induction and after admission to the post-anesthetic care unit and decrement of postoperative haemoglobin and amount of transfusion were reviewed.

A correlation coefficient of ρ = 0.4 was calculated from a pilot study. We need at least 44 subjects with an α value of 0.05 and a power of 0.8.

Eligibility Criteria:
Inclusion Criteria:

* patients who underwent primany unilateral total knee replacement arthroplasty under general anesthesia
* patients who had FIBTEM performed

Exclusion Criteria:

* surgery under regional anaesthesia
* a simultaneous bilateral total knee replacement arthroplasty
* the second surgery of staged total knee replacement arthroplasty
* revision of total knee replacement arthroplasty
* patients who received intraoperative transfusion
* patients who use tranexamic acid
* patients who received fibrinolytic agents because of perioperative thromboembolic event
* patients who refused transfusion because of religious belief of personal causes
"Red Morphine Drops" for Symptomatic Treatment of Dyspnoea in Lung Cancer

The purpose of this study is to test whether "red morphine drops" applied in the mouth are superior to an equivalent amount of morphine applied as subcutaneous injection for the relief of breathlessness in terminal patients suffering from primary lung cancer or lung metastases.

Breathlessness or dyspnea in terminal cancer patients with lung cancer is common and opioids such as morphine is the mainstay of symptomatic treatment. Subcutaneous administration of morphine provides fast symptomatic relief, but it has been the impression in our institution that "red morphine drops" applied orally may have equal or better efficacy and faster onset time.

Comparison: Patients with lung cancer or lung metastases with moderate to severe dyspnea at rest are treated with either orally applied "red morphine drops" or an equivalent amount of morphine applied subcutaneously.

Eligibility Criteria:
Inclusion Criteria:

* Primary lung cancer or lung metastases and
* Moderate to severe dyspnea at rest (VAS equal to or more than 30)

Exclusion Criteria:

* Causal treatment of dyspnea possible and indicated
* Not receiving opioids on a regular basis
* Methadone treatment
* Intolerance to morphine
* Without understanding of patient information
* Depressed consciousness
* Oxygen treatment, if changed with-in 20 min before start
* Short-acting opioids with-in 4 h before start
* Inhalation therapy for bronchodilation with-in 20 min before start
Electrophysiological Evaluation of Voluntary Attention

Aim : To assess the ability of healthy subjects and patients with a severe motor disability to voluntary control their attention

Material and Methods:

Population: healthy subjects, patients with brain injury Electroencephalographic study to research attentional modulation during different kind of stimulation (visual, auditory, tactile)

Sudy 1: passive recording.

Study 2: active recording (instruction of attentional control given to the subject).

Study 3: active recording with a feedback obtained after a processing of the brain activity.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for patients :

* Adults, man or woman, left or right-handed, from 18 years old to 80 years-old ;
* Diagnosis :

  * Locked-in syndrome :

\< Brainstem injury, without any evolution for at least 3 week, etiology : vascular, traumatic \< Amyotrophic Lateral Sclerosis \< Following damage to the central or peripheral nervous system

* Or Minimal conscious state or Unresponsive Wakefulness Syndrome consecutive to a severe acquired brain injury for at least one month
* Or with a severe brain injury, since birth or acquired, for at least one month
* Or with Guillain-Barré syndrome

  * Subjects affiliated to social security;
  * Signature of consent form by the patient or by a relative (family member or "the trusted person") if obtaining a consent is impossible

Inclusion criteria of Healthy subjects

* Adults, man or woman, left or right-handed, from 18 years old to 80 years-old ;
* Without known auditory impairment
* Subjects able to understand the experimental instructions
* Subjects affiliated to social security;
* Signature of consent form

Exclusion criteria of patients and healthy subjects

* Medical history : psychiatric disorders (except if due to brain injury), neurologic disorders (except if due to brain injury)
* For healthy subjects : history of brain injury
* Pregnant women or breastfeeding women
* Person under legal protection
* Medico-legal conflicts
* Absence of consent by the subject or the patient or his/her representant
Goal-directed Intraoperative Fluid Therapy in High-risk Surgery

This study is aim to assess the effect of goal-directed intraoperative fluid therapy on patient's postoperative incidence rates of complications, length of hospitalization and hospitalization cost.

This is an observational study followed cohort study design, due to the two therapies were not randomized assigned to the two cohorts. The details are described as follow.

The study will be conducted in patients undergoing either elective laparotomy of gynecological malignancies or elective major orthopaedic surgery under prone position in Peking Union Medical College Hospital. The study included two stages.

In the first stage, one cohort of 300 participants with conventional fluid therapy will be involved, in which 150 patients will be selected with laparotomy of gynecological malignancies and150 patients will be selected with orthopedic surgery. All the participants in this stage will follow conventional fluid therapy to direct the amount of intraoperative fluid. Specifically, the fluid will be administered based on the principle crystalloid solution (colloid solution =2-3:1). The total volume of fluid will be adjusted in accordance with blood pressure, heart rate and urine output of each patient. It is a standard procedure in Peking Union Medical College Hospital. Then, the incidence of postoperative complications of each group will be recorded. In addition, sample size will be estimated based on above study's results (estimated 100 participants).

In the second stage, goal-directed therapy will be applied to another cohort of 300 participants, in which 150 patients undergoing laparotomy of gynecological malignancies and 150 patients undergoing orthopedic surgery. Specifically, the fluid will be administered based upon real-time monitoring stroke volume variation and cardiac output achieved by the Flo-Trac monitoring system. The incidence of postoperative complications of each group will be recorded.

Eligibility Criteria:
Inclusion Criteria:

1. Receiving elective laparotomy of gynecological malignancies (LGM): including cytoreductive surgery of ovarian cancer, radical hysterectomy and staging surgery of endometrial cancer ;
2. Major elective orthopedic surgery (OS): including spinal surgery, revision surgery of hip joints ;
3. Age ≥18 years, American Society of Anesthesiologists physical status I ～IV;
4. No arrhythmia;
5. Receiving general anesthesia;
6. Requiring monitoring of direct blood pressure due to the comorbidities of patients and the nature of surgical procedures.

Exclusion Criteria:

1. Emergent surgery;
2. Patients with aortic regurgitation;
3. Patients with aortic stenosis, peripheral arterial diseases or other diseases contradicting to arterial canalizations;
4. Patients with mental disorders or low intelligence quotient; patients who cannot cooperate or refuse to sign the consent.