cyrilzakka/clinical-trials huggingface dataset:
Effects of Parenteral Nutrition in HSCT

Nutritional therapy implementation in hematopoietic stem cell transplantation (HSCT) have undergone changes recently due to new conditioning regimen and graft versus disease prophylaxis, novel enteral and parenteral nutrition solutions: the value of enteral nutrition is increasing, the indications for parenteral nutrition are becoming more strict. The study aims to identify the role of parenteral nutrition in the context of rapidly changing supportive care approaches in HSCT

The study is interventional: in children and adolescents (2-17 years), adults with blood malignancy and inherited diseases who underwent autologous or allogeneic HSCT, nutritional status, parenteral nutrition tolerability and effectiveness will be assessed before and one month after HSCT. All patients who require parenteral nutrition will pass randomization via envelope technique - solutions containing glucose/amino acids or glucose/amino acids/lipid emulsions. The results will be compared with a control group which will not receive additional nutritional support. The methods used for measurement of nutritional status are: weight, body mass index, bioimpedance and hand grip strength (for adults only), blood tests, diet amount record.

Eligibility Criteria:
Inclusion Criteria:

* Autologous HSCT
* Allogeneic HSCT
* Patients with indications for parenteral nutrition defined as unable to eat more than 50% of oral food intake due to posttransplant complications which leads to malnutrition and malabsorption
* Signed informed consent
* Age \> 2 years

Exclusion Criteria:

- Secondary HSCT
Phase 1 Study of ONO-7475 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid Tumors

To evaluate the tolerability and safety of ONO-7475 monotherapy and combinations with ONO-4538 in patients with advanced or metastatic solid tumors


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically or cytologically confirmed advanced or metastatic solid tumors
* ECOG Performance Status 0～1
* Patients with life expectancy of at least 3 months

Exclusion Criteria:

* Patients with history of severe allergy
* Patients with multiple cancers
Right Ventricular Dysfunction in Septic Shock Patients in ICU

Assesment of right ventricular dysfunction in septic shock patients in intensive care unit.

Over the last decade, a few studies have highlighted the crucial role of right ventricular (RV) function in hemodynamic and respiratory diseases in critical care 1,2. However, RV failure is difficult to define in the critical care setting. A recent consensual definition proposed by different groups of experts characterizes RV failure as the association of a significant RV dilatation associated with systemic congestion 3-5. This definition is mainly physiologically based, not strictly validated, and the experts did not propose any threshold for RV size or congestion using critical care echocardiography (CCE) and central venous pressure (CVP), respectively.

Fluid management in septic shock is crucial for prognosis, as fluid overload and high CVP are associated with a worse outcome 6. Septic shock is expected to impair RV function through the development of septic cardiomyopathy, but the incidence of RV failure is unknown.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with septic shock.
2. Patients will be evaluated within 24 h after diagnosis.

Exclusion Criteria:

1. Patients diagnosed more than 24 hours.
2. Patients with associated ischemic heart failure .
Continuous Glucose Monitoring by Subcutaneous Measurement Compared to Frequent Point of Care Measurement by Accu Chek in Critically Ill Patients

The purpose of this study is to evaluate the accuracy and reliability of the continuous glucose monitoring system the FreeStyle Navigator® (Abbott, Diabetes Care) in critically ill patients by comparing subcutaneous measuring with the current standard of arterial measuring by a point of care glucometer.

Most patients admitted to the ICU are treated with intensive insulin therapy, according to a locally developed glucose treatment protocol. The use of a continuous glucose monitoring in critically ill patients could have the following advantages:

* Better insight in the alterations of the blood glucose levels
* Early detection of hypoglycemia's or hyperglycaemia's, and subsequently more stable glycemic levels.
* Fewer blood samples
* Decreased workload for the nursing staff

In this study, patients will be randomized in: 1. The Freestyle group or 2. The AccuChek Group.

Patients in both groups will receive a Freestyle Navigator device, which will stay on the patient up to 5 days, or until discharge from the ICU.

The medical treatment of both study groups will be equal, except for the frequency of the glucose level measurements and the resulting adjustments according to the treatment protocol. In the Freestyle group extra glucose level measurements will be made in response to alarms from the device.

In both groups, every 4 hours blood glucose values will be obtained using a blood gas analyzer (BGA). When a control measurement by BGA results in a glucose level of \<2.2 or \>25 mmol/l, the value will be transmitted to the Patient Data Management System (PDMS) and gives an alarm. Otherwise, the value will be blinded in the PDMS.

Freestyle Navigator data will be downloaded from the device. Blood glucose values obtained in the course of usual care will be compared with time-matched Freestyle Navigator values to assess device accuracy.

Eligibility Criteria:
Inclusion Criteria:

* ICU-patients \> 18 years
* Expected length of stay on the ICU \> 24 hours
* Indication for glucose regulation with insulin (according to the current glucose treatment protocol)
* Availability of the Freestyle Navigator

Exclusion Criteria:

* Participation in another trial subject to the WMO
* Lack of informed consent
* Contraindication for the use of the Accu Chek (for example peritoneal dialysis, Ht \<0,20 of \> 0,65; paracetamol intoxication)
* Contraindication for placement of the subcutaneous glucose sensor
* Participation in this trial during previous ICU admittance
A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia

This 2 arm study will evaluate the efficacy and safety of oral Bonviva 150mg once monthly compared with placebo in post-menopausal women with osteopenia. Patients will be randomized to receive either Bonviva 150mg po monthly, or placebo monthly. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* women 45-60 years of age;
* post-menopausal;
* ambulatory.

Exclusion Criteria:

* vertebral fracture (except traumatic fracture such as in a motor vehicle accident);
* low-trauma osteoporotic fracture in any other bone;
* breast cancer diagnosed within last 20 years;
* other malignancy diagnosed within last 10 years, except successfully resected basal cell cancer;
* treatment with any bisphosphonate within last 2 years;
* treatment with other drugs affecting bone metabolism within last 6 months.
Suicide in People Aged 45-60: A Case-control Psychological Autopsy Study

The purpose of this study is to learn about the possible causes of the negative trend in suicide rates in both males and females aged 45-60 in Flanders, Belgium. This will be carried out using a psychological autopsy study.

A case-control psychological autopsy study will be carried out to identify what risk factors are related to suicide in people aged 45-60. People close to the person who died by suicide (next of kin or close friends) will be interviewed. To increase the validity of our findings, a control group will also be interviewed. The control group will be someone who is very close to someone with mental health problems.

Eligibility Criteria:
Inclusion Criteria:

* close to suicide victim or person who has mental health problems
* suicide victim or person with mental health problems was/is 45-60 years old
* the suicide happened more than 3 months and less than 5 years ago

Exclusion Criteria:

* not Dutch-speaking
Single-Port Versus Multi-Port Robotic Radical Prostatectomy

The purpose of this study is to compare two different techniques to perform the standard of care surgery to treat prostate cancer. This surgery is called robotic radical prostatectomy. There are two robotic surgical systems approved by the Food and Drug Administration (FDA) to perform this surgery. First system is called the Da Vinci ® Xi system. With this system, six small incisions are made during the surgery. Second system is called the Da Vinci ® SP system. With this system a single incision is made during the surgery. Same surgery is done with each surgical system. This study aims to understand whether a single incision surgery ends up with better recovery after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have histologically or cytologically confirmed prostate cancer, stage T1a, T2a or T2b prostate cancer using MRI staging.
* Life expectancy greater than 10 years.
* Participants must have ability to understand and the willingness to sign a written informed consent document or have a surrogate with the ability to understand and the willingness to sign a written informed consent for radical prostatectomy.

Exclusion Criteria:

* Participants with any prior extensive pelvic surgery or pelvic fractures.
* Prior treatment for prostate cancer such as radiotherapy or focal therapy.
* Uncorrected coagulopathy.
* Active soft tissue or urinary infection.
* Poor surgical risk (defined as American Society of Anesthesiology score \> 3)
* Any condition or history of illness or surgery that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient (e.g. significant cardiovascular conditions that significantly affect the life expectancy, chronic opiate use, pain syndrome, or drug abuse.)
* Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Analgesic Effect of an Injection of Botulinum Toxin Type A in the Ganglion Impar in Patients With Chronic Proctalgia

The main objective is to evaluate the analgesic efficacy of botulinum toxin type A in refractory chronic proctalgia one month after a bilateral injection of 50 units of Botox ® in the ganglion Impar (total dose = 100 units)


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Patient with chronic proctalgia according to the criteria of Rome III
* Chronic or recurrent rectal pain
* Pains evolve over periods of at least 20 minutes
* With the exclusion of other causes of rectal pain: ischemic, inflammatory bowel disease, cryptic lesions, intramuscular abscess, anal fissure, hemorrhoids, prostatitis and isolated coccydynia
* Pains evolve in a regular way since more than 3 months and the symptoms started since at least 6 months
* These chronic proctalgia include syndromes of anus elevator and nonspecific functional anorectal pains
* Patient with positive anesthetic block of ganglion Impar (minimum of 30 days before D0 and maximum of 270 days before D0)
* Main score (SP) ≥ 4 before infiltration of botulinum toxin type A
* Signed informed consent
* Subjects affiliated with an appropriate social security system

Exclusion Criteria:

* Pain related malignancy
* Patients with bleeding risk and recent anticoagulant therapy
* Surgery within 3 months
* Pre-existing anal incontinence
* Intolerance of botulinum toxin A, local anesthetics and radio contrast medium
* Injection of botulinum toxin in any place whatsoever in the previous 3 months
* Pregnancy and breast feeding
* Antibiotic treatment by aminoglycosides
* Recent anti-inflammatory treatment
* Severe myasthenia
* Lambert-Eaton syndrome
* Patients with neurological disorders, dysphagia, food choking or inhalation pneumonia
Case Series to Evaluate Patient Specific Implants (PSI) in Polyether Ether Ketone (PEEK) Performance After 2 Years

The primary objective of this retrospective study is to evaluate the percentage of patients with device related adverse events (infection, rejection, dislocation, fracture of the implant) in the first 24 months after implantation.


Eligibility Criteria:
Inclusion Criteria:

* Males or females age 18 years or over at the time of inclusion into the study
* Received a Synthes PSI® made of PEEK intended for replacement of bony voids in the cranial/craniofacial skeleton at least 24 months before inclusion in the study
* Ability to obtain written informed consent from the recipient or the recipient's legal guardian
* Ability to comply with the procedures described in the protocol, including responding to simple questionnaires either by the recipient in person or by a next relative (spouse, parent) who lives with the recipient

Exclusion Criteria:

* Patient was contraindicated to receive a PSI made of PEEK at the time of implantation
The Effect of Ingesting or Rinsing Sucrose and Sucralose on Self-control, Cognitive Performance, and Blood Glucose

The purpose of this study is to examine the effects of ingesting or mouth rinsing a sucrose (carbohydrate) versus a sucralose (carbohydrate-free) drink on self control, cognitive performance, and blood glucose level.


Eligibility Criteria:
Inclusion Criteria:

* BMI 18 - 29 kg/m2

Exclusion Criteria:

* Dementia
* Depression
* Type 2 diabetes
* Phenylketonuria
* Intake of medication known to affect glucose metabolism
* Fasting blood glucose \> 7.8 mmol/L
Efficacy and Safety of DA-3002 in Short Children Borns SGA.

A study demonstrates the non-inferiority of DA-3002 when compared with Genotropin® in short children born small for gestational age.


Eligibility Criteria:
Inclusion Criteria:

* Chronological Age ≥ 4
* Before the adolescence, Tuner stage I (breast)
* Height \<3rd percentile for age
* Normal thyroid function

Exclusion Criteria:

* Growth hormone was administered for 12 months or longer in the past
* Treated with estrogen or adrenal androgens for 12 months or longer in the past
* Malignancy, CNS Trauma, Psychiatric Disorder
* endocrine and/or metabolic disorders
* growth failure caused by other disorders
Mass Response of Tumor Cells As a Biomarker for Rapid Therapy Guidance (TraveraRTGx)

The primary objective of this study, sponsored by Travera Inc. in Massachusetts, is to validate whether the mass response biomarker has potential to predict response of patients to specific therapies or therapeutic combinations using isolated tumor cells from various specimen formats including malignant fluids such as pleural effusions and ascites, core needle biopsies, fine needle aspirates, or resections.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is ≥18 years of age
2. Written Informed Consent provided by patient
3. Diagnosis of any kind of carcinoma
4. Malignant fluid (e.g. pleural effusion or ascites) drainage OR tumor tissue resection OR tumor tissue needle biopsy is clinically indicated as part of SOC
5. Proceeding onto therapy for treatment
6. Informed consent obtained for the XCELSIOR longitudinal outcomes registry (NCT03793088)

Exclusion Criteria:

1. Lack of informed consent
2. Unable to obtain sufficient sample
Assessment of Antibody Persistence in Children Previously Vaccinated With Pneumococcal Conjugate Vaccine

This protocol posting deals with objectives \& outcome measures of the extension phase up to 48-50 months post booster vaccination, to assess long-term antibody persistence in children at around 30, 42 and 66 months of age, who received previously 4 doses of pneumococcal conjugate vaccine. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = 00307554). This Protocol posting has been updated in order to comply with the FDA AA (Sep 2007).

This study consists in a serological follow-up study to evaluate persistence 12, 24 and 48 months after the booster vaccination study (107046). No study vaccines will be administered within this study.

Eligibility Criteria:
Inclusion Criteria:

* Male or female between, and including, 28-30 months of age at the time of first blood sampling.
* Subjects who previously participated in the 105553 and 107046 studies and who received a full four dose regimen of pneumococcal conjugate vaccine during the primary and booster studies.
* Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
* Written informed consent, covering visits 1, 2 and 3, obtained from the parent or guardian of the subject.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the blood sampling
* Administration of any additional pneumococcal vaccine since end of 107046 study.
* Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the blood sampling.
* Administration of immunoglobulins and/or any blood products less than 6 months prior to blood sampling.
* Any confirmed or suspected immunosuppressive or immunodeficient condition since the end of the 107046 study, based on medical history and physical examination.
Open-Label Extension of Other SZ1839 (Iressa) Trials

A trial to assess patients who have been treated with Iressa in a previous clinical trial and may benefit from continued treatment with Iressa.


Eligibility Criteria:
Inclusion Criteria:

* Received treatment in a previous Iressa clinical trial
* Provided Informed Consent to participate in the trial
* 30 days or less since completing the previous Iressa trial.

Exclusion Criteria:

* Radiotherapy completed more than 14 days before starting treatment in this trial
* Incomplete healing from prior surgery
* Withdrawal from previous Iressa trial due to unacceptable toxicity to major organs
Visual Inspection With Acetic Acid Compared to Lugol's Iodine in HIV-infected Women

The clinical trial is part of a larger study to evaluate the safety and efficacy of screening techniques for cervical cancer among HIV-infected women. The investigators randomized women to undergo screening with Visual Inspection with Acetic Acid (VIA) or Visual Inspection with Lugol's Iodine (VILI), along with a colposcopy. All outcome and treatment decisions were based on the colposcopy exam done at the study visit. The investigators then compared outcomes between the two groups to assess the test characteristics of both VIA and VILI.

Cervical cancer and HIV are intersecting epidemics that both disproportionately affect low-income women; the impact of the socioeconomic disparity and biologic synergy of these two diseases is seen dramatically in Kenya, where cervical cancer is the most common cancer killer. HIV-infected women are at increased risk for the development of cervical precancer and cancer, develop more aggressive lesions and are affected at younger ages. Although screening for and treatment of precancer has reduced the incidence of cervical cancer to close to zero in resource-rich countries, strategies are costly and not available in most resource-limited countries. Novel testing and treatment methods that can be carried out in low-resource settings are urgently needed to prevent cervical cancer in these settings, especially among HIV-infected women. Using a cross-sectional study design, the investigators tested two potentially low-cost and effective cervical cancer screening methods: visual inspection with acetic acid (VIA) and protein biomarkers expressed in the presence of cervical dysplasia, neither of which have been well-studied in HIV-infected women. Investigators also randomized a small subset of women to undergo VIA compared to Visual Inspection with Lugol's Iodine (VILI) to compare the test characteristics of these two screening exams. In addition, remarkably little is known about the potential impact of the presence, diagnosis and treatment of human papillomavirus-related dysplasia on HIV genital shedding, a major risk factor for HIV transmission. To explore the impact of the presence, diagnosis and treatment of human papillomavirus-related cervical dysplasia on HIV-1 in genital secretions, investigators compared the levels of HIV-1 RNA found in the cervicovaginal secretions of women with no evidence of cervical dysplasia to levels in women with high-grade cervical dysplasia. They also compared the levels of HIV-1 RNA prior to and after cervical biopsy as well as up to 14 weeks after standard treatment for cervical dysplasia using loop electrosurgical excision procedure (LEEP). Results from this study will inform the prioritization and design of safe, effective and low-cost cervical cancer screening and prevention programs for HIV-infected

Eligibility Criteria:
Inclusion Criteria:

* 23-59
* Intact cervix/uterus
* no evidence of infection
* ability to provide informed consent

Exclusion Criteria:

* pregnant
Sulfur Colloid SPECT/CT in Measuring Liver Function in Patients With Primary or Metastatic Liver Cancer Undergoing Radiation Therapy or Surgery

This pilot trial studies how well single photon emission computed tomography (SPECT)/computed tomography (CT) with technetium Tc-99m sulfur colloid works in measuring liver function in patients with liver cancer that has or has not spread to other place in the body who are undergoing radiation therapy or surgery. Diagnostic procedures, such as sulfur colloid SPECT/CT scans, may measure normal liver tissue before, during and after treatment and help doctors plan better treatment for liver cancer patients.

OUTLINE: Patients are assigned to 1 of 2 cohorts depending on which standard of care they are receiving outside of this study, as part of their cancer treatment: RT or surgery.

All patients have a total of 3 SPECT/CT imaging with 99mTc-SC. The first scan in both cohorts is routine medical care (not experimental) and takes place prior to initiation of RT or surgery. Two follow up scans are part of the protocol.

COHORT A (patients receiving radiation therapy per standard cancer treatment): The first follow up scan occurs at mid-RT, and the second one at 1 month post-RT.

COHORT B (patients undergoing surgery per standard cancer treatment): The first follow-up scan occurs 3-5 days postoperatively, and the second one at 1 month post-operatively. An additional intravenous (IV) contrast enhanced CT scan (70 second delay) will be obtained immediately following the SPECT/CT scan for all 3 SPECT/CT scans.

After completion of study, patients are followed up at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma, or metastatic liver cancer planned to receive definitive doses of radiation or surgical resection are eligible
* Measurable hepatic disease and/or presence of vascular tumor thrombosis
* Diagnostic CT or magnetic resonance imaging (MRI) scan within 2 months of study entry
* There are no limits on prior therapy; patients are allowed to have prior systemic therapy, radiation therapy, radiofrequency ablation, catheter-based therapies, and surgery; patients are allowed to have concurrent chemotherapy with radiation treatment
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Patients unable to tolerate a SPECT/CT 99mTc-SC scan
* Patients who are not planning to adhere to the required follow up schedule as outlined in this protocol
* Pregnant women
* Women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
* Patients unable to provide informed consent