cyrilzakka/clinical-trials huggingface dataset:
Ph I Safety and Efficacy of ODSH in Patients Receiving Induction or Consolidation Therapy for Acute Myeloid Leukemia

This is an open-label pilot study evaluating the safety and preliminary evidence of a therapeutic effect of ODSH (2-0, 3-0 desulfated heparin) in conjunction with standard induction and consolidation therapy for acute myeloid leukemia.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed, previously untreated acute myeloid leukemia. Acute promyelocytic leukemia is excluded.
* No prior chemotherapy for acute myeloid leukemia; however, prior hydroxyurea to control white blood cell count is allowed.
* No prior chemotherapy or lenalinomide for treatment of myelodysplastic syndrome.
* Age: 18-70.
* ECOG Performance status 0-2
* Cardiac ejection fraction ≥ 50% (echocardiography or MUGA \[multigated acquisition\])
* Adequate hepatic and renal function (AST \[aminotransferase\], ALT \[alanine aminotransferase\], bilirubin and creatinine \< 2.5 x upper normal limit).
* Able to provide informed consent and have signed an approved consent form that conforms to federal and institutional guidelines.

Exclusion Criteria:

* Patients with acute promyelocytic leukemia
* Patients with acute megakaryoblastic leukemia
* Patients with CNS (central nervous system) leukemia
* Presence of significant active infection or uncontrolled bleeding
* Any coexisting major illness or organ failure which contraindicates the dose-intensive chemotherapy regimen prescribed by this protocol
* Pre-existing liver disease that might impair ODSH clearance
* History of other active malignant disease within 5 years, other than cured basal cell carcinoma of the skin, cured in situ carcinoma of the cervix, or localized prostate cancer that has received definitive therapy. Such prostate cancer patients who are receiving hormonal therapy are eligible
* Use of recreational drugs or history of drug addiction, within the prior 6 months
* Known history of positive hepatitis B surface antigens or hepatitis C antibodies
* Known history of positive test for HIV (Human immunodeficiency virus) antibodies
* Psychiatric or neurologic conditions that could impair ability to give proper informed consent
* Presence of symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia
* Presence of uncontrolled thrombotic or hemorrhagic disorder
* A medical condition that requires the need to be on chronic anticoagulation
* Presence of any other serious uncontrolled medical disorder
* Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to study entry
* Pregnant or breast-feeding patients
* Patient with childbearing potential not using adequate contraception
* Hemorrhage risk that requires maintenance of platelet counts at 50,000/uL or higher.
* Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results
Thromboelastogram in Postdelivery Preeclamptic Patients

There are no studies evaluating the effect of aging on hemostasis of preeclamptic patients. Additionally, although there are some studies that establish normal reference values for TEG profiles in healthy term pregnant patients, conflicting results have been found in preeclampsia. Reference values are important to establish baseline parameters in cases of pre-eclampsia complicated by postpartum hemorrhage. The investigators will evaluate reference values for TEG in postdelivery preeclamptic patients and the difference between vaginal delivery and cesarean section.

After approval by the Institutional Review Board and informed consent from participants, the investigators are obtaining blood samples for TEG processing, from pregnant patients admitted to the maternity unit of Augusta University Medical Center. Patients are being classified in 2 groups: term pregnant patients with diagnosis of pre-eclampsia who undergo cesarean section and those having spontaneous vaginal delivery. Each group will be divided into subgroups according to maternal age: 18-25 years, 26-35 years, \>36 years. Pre-eclampsia is defined and classified according to the definitions of the American College of Obstetricians and Gynecologists published in 2013.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years Mental competence Gestational age \> 37-week Informed consent Diagnosis of preeclampsia (with or without features of severity)

Exclusion Criteria:

Gestational age \< 37-week Known bleeding or thrombotic diathesis Use of aspirin or unfractionated or low-molecular weight heparin within the last 48 hours BMI \> 35 Maternal comorbid conditions other than preeclampsia
Oocyte Survival After Vitrification in an Open or Closed Device With Closed Storage.

The survival rate (and embryo quality) of donor oocytes with two commercially available devices.

Donor sibling oocytes will be vitrified with two commercially available devices. The first device is closed vitrification with closed storage and the second device is open vitrification with closed storage. Oocyte acceptors receive oocytes from both devices. With the increase in cooling rate generated by the open vitrification (second device), we expect to get an increase in survival rate of 10%. Besides this, embryo quality will be assessed with oocytes obtained from both devices.

Eligibility Criteria:
Inclusion Criteria:

* Donor: ≤36 years old on day of oocyte retrieval
* Donor: ≥ 6 mature oocytes

Exclusion Criteria:

* Donor: \< 6 mature oocytes
Assessment of DNA Damage Due to Ionizing Radiation

detection of DNA damage due to occupational exposure to low dose ionizing radiation using comet assay technique and genotyping of certain DNA repair genes to detect inherited polymorphism.


Eligibility Criteria:
Inclusion Criteria:

* • The radiation exposed workers will include nurses, technicians and physicians.

These persons will be occupationally exposed to different radiation sources.

Exclusion Criteria:

* History of diagnostic X-rays, radiotherapy and/or chemotherapy 12 months prior to sampling.
Measured Hypocretin Levels and Recovery After Hip Surgery

A specific group of neurons in the brain produces hypocretin, a peptide which has been established as an important regulator of sleep and wakefulness. Activation of these neurons (increased hypocretin) stabilizes wakefulness; impairing or blocking these neurons (decreased hypocretin) promotes sleep. Evidence suggests that these neurons may be involved in the hypnotic properties of several anesthetics, and play a role in the induction and emergence from anesthesia. In humans there is a considerable inter-individual variability in hypocretin levels. This study aims to investigate how hypocretin levels affect the anesthetic care and recovery of patients undergoing elective hip surgery.


Eligibility Criteria:
Inclusion Criteria:- Adult (18 years of age or older)

* Male or female
* Scheduled for elective total hip arthroplasty at the Stanford Orthopedic Clinic.
* Comprehend spoken and written English Exclusion Criteria:- ASA physical status \> III (patients with severe systemic disease)
* Diagnosed psychiatric disease (except mild depression)
* Any diagnoses CNS disease or dementia
* History of stroke
* History of untreated thyroid disease
* Difficulty in airway management (ventilation and/or intubation)
* Body Mass Index (BMI) \> 35 kg/m2
Robust Intelligent Keyboard for Quadraplegic Patients

This is multi-center prospective randomized trial evaluating the effectiveness of a new brain-computer interface for communication of quadriplegic patients in a clinical context. This performance of this will compared to traditional assistive technology (scanning system) and to performance of a healthy volunteer population.

The evaluation aims to estimate the performance of BCIs in patient and healthy subjects in a clinical setting (primary objective) and to compare this performance with an existing assitive technology adapted to the target population of this study (scanning system). A quadriplegic patient population (n = 10) evaluated the two techniques and a population of healthy subjects (n = 10) evaluated the BCI only.

When a subject meets all the eligibility criteria and is not discarded by any non-inclusion criteria, he is included in the study. The order of the two techniques to be compared is randomized.

Eligibility Criteria:
Inclusion Criteria:

Healthy volunteers:

* Informed consent
* Adults aged more than 18yo
* Passed complete medical check-up (heart-rate, blood pressure,...)
* Negative pregnancy test

Quadripleagic patients:

* Informed consent
* Adults aged more than 18years
* Passed medical exam
* Negative pregnancy test
* Full medical checkup
* haemodynamic stability

Exclusion Criteria:

Healthy volunteers:

* history of epilepsy or seizure
* auditory or visual deficit
* atopic scalp dermatitis
* hypersensitivity to gold
* curator/guardianship/under protection of judicial authority
* unable to understand the information note and/or to cooperate
* no social security
* can't read

Quadripleagic patients:

* history of epilepsy or seizure
* auditory or visual deficit
* cerebral lesion
* atopic scalp dermatitis
* hypersensitivity to gold
* curator/guardianship/under protection of judicial authority
* unable to understand the information note and/or to cooperate
* no social security
* can't read
* included in a different clinical trial with exclusion period
Cost of Long Term Disability in Patients With Chronic Non-Specific Low Back Pain

The purpose of the study was to determine the cost-effectiveness of a function-centred treatment (FCT) compared with a pain-centred treatment (PCT) in patients with chronic low back pain (LBP) in an in-patient setting. Follow-up lasted three years. Direct and indirect costs were recorded by questionnaires sent to health insurances, employers and Swiss Disability Insurance Company.


Eligibility Criteria:
Inclusion Criteria:

* Chronic low back pain, sick leave of 6 weeks during the last 6 months

Exclusion Criteria:

* not able to perform a training program
Observational Database on Deep Brain Stimulation in Tourette Syndrome

Within an ongoing deep brain stimulation (DBS) program for Tourette syndrome (TS) at the Department of Neurology, Pitié-Salpêtrière Hospital, Paris/France, the investigator team plans to evaluate patients pre-operatively and then at one year intervals post-operatively until the 5-year mark has been achieved. The investigator team will investigate tic severity, psychiatric co-morbidities, quality of life, and neuropsychological measures.

Since the completion of the STIC trial in 2017, the french team continues to offer DBS of the globus pallidus internus (GPi) to selected, treatment-refractory patients with TS. On average, three to four patients undergo surgery every year. Even though a first follow-up of the STIC cohort up to four years post-op indicates ongoing improvement of tic severity, many questions remains regarding the efficacy of GPi DBS in TS. These questions include frequent comorbidities of TS, quality of life, evolution of medication and stimulation parameters, as well as neuropsychological functioning. Therefore, the investigator proposes to evaluate all patients undergoing GPi DBS for TS to be evaluated comprehensively pre-operatively and once yearly after surgery until reaching the 5-year mark. The investigator team hopes these data may help to plan for future international multicenter trials, and provide indications on prognostic factors concerning response to GPi DBS in TS.

Eligibility Criteria:
Inclusion Criteria:

* Tourette syndrome severe and drug-resistant eligible for bilateral deep brain stimulation
* Person who voluntarily and knowledgeably agreed to participate in the study

Exclusion Criteria:

* Non affiliation to a French social security system (recipient or assign) excluding AME
Safety and Efficacy of AN2728 Topical Ointment, 2% in Children, Adolescents, and Adults (Aged 2 Years and Older) With Atopic Dermatitis

The purpose of this study is to investigate the safety and efficacy of AN2728 Topical Ointment, 2% in children, adolescents, and adults (ages 2 years and older) with atopic dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Males or females 2 years and older
* Has a clinical diagnosis of Atopic Dermatitis (AD) according to the criteria of Hanifin and Rajka
* Has AD involvement ≥ 5% Treatable %BSA (excluding the scalp)
* Has an ISGA score of Mild (2) or Moderate (3) at Baseline/Day 1
* All female subjects of childbearing potential must use acceptable methods of contraception from the Screening Visit continuously until 30 days after stopping study drug

Exclusion Criteria:

* As determined by the study doctor, a medical history that may interfere with study objectives
* Unstable AD or any consistent requirement for high potency topical corticosteroids
* History of use of biologic therapy (including intravenous immunoglobulin)
* Recent or anticipated concomitant use of systemic or topical therapies that might alter the course of AD
* Recent or current participation in another research study
* Females who are breastfeeding, pregnant, or with plans to get pregnant during the participation in the study
* Participation in a previous AN2728 clinical trial
Effect of Galactooligosaccharides on Incidence of Atopic Manifestations in Infants

Addition of prebiotic galactooligosaccharides to hypoallergenic starter formula would lead to decreased allergic (atopic) symptoms in nonbreastfed infants with a positive history of allergy in family


Eligibility Criteria:
Inclusion Criteria:

* nonbreastfed eutrophic infants of corresponding gestational age
* presence of a positive family allergic anamnesis in parents or siblings (atopic eczema, allergic rhinitis or bronchial asthma)

Exclusion Criteria:

* children with serious disease,
* breastfed children
* children fed another formula then the ones used
Survival Rate of All Ceramic Restorations Treated With Air-Water-Blasting Protocol

This study evaluates retrospectively the survival rate of all-ceramic restorations, cemented using AWB technique (test) compared to those cemented with conventional technique (control)

A retrospective study on ceramic restorations, placed in the period 2003-2014, will be performed to assess the survival rate of all-ceramic restorations cemented adhesively. The effectiveness of cementation largely depend on the method used. The Air-Water-blasting performed prior to conventional acid-etch of dental tissues offers an increase in bond strength compared to the conventional etching technique.

Eligibility Criteria:
Inclusion Criteria:

* patients who received at least one ceramic restoration

Exclusion Criteria:

* patients who received feldspathic ceramic restorations
Tuberculosis in HIV Infected Patients in Uganda

This was a clinical trial in HIV infected patients with tuberculosis. The study assessed whether the addition of prednisolone, a type of steroid medication, to the standard treatment for tuberculosis improved immune and viral outcomes in the patients. The study demonstrated that prednisolone increased the CD4 cell count as was hoped, but the beneficial effect was short-lived and was gone within 4 months of stopping therapy. Therefore, the use of prednisolone for tuberculosis in HIV infected patients is not recommended at this time.

Recent observations from retrospective cohort studies indicate that HIV-associated tuberculosis (TB) is associated with reduced survival and increased rate of opportunistic infections compared to CD4-matched controls. Mounting evidence from immunologic and virologic studies supports the concept of co-pathogenesis, in which cytokines such as tumor necrosis factor alpha (TNF alpha) are over-expressed during the course of TB and stimulate viral replication in latently infected cells, possibly leading to greater viral load.

Glucocorticoids are potent inhibitors of cytokines, including TNF, and clinicians have extensive experiences with their use in HIV infection. Although corticosteroid use in HIV infection has a record of safety, the safety and bioavailability of corticosteroids in HIV/TB coinfection has not been established.

This study evaluated the change in viral load and CD4 count in HIV infected patients with TB who were treated with oral prednisolone. The study found that the viral load increased slightly when prednisolone was administered and that patients receiving prednisolone cleared their tuberculosis more rapidly. Although there was some benefit to using prednisolone in these patients, the benefit was short-lived and was gone within 4 months of stopping therapy.

Eligibility Criteria:
Inclusion Criteria

* Pulmonary TB (smear positive)
* HIV infected
* Residence within 20 km of Kampala city
* Allows frequent blood specimens to be drawn
Developing an US-MRI Biomarker Fusion Model for Endometriosis

Single centre, prospective, observational, cohort study looking to develop a database representing the variability of disease and imaging seen in women with clinically diagnosed endometriosis, awaiting laparoscopic surgery.

In the United Kingdom (UK), endometriosis is one of the most common gynaecological diseases needing treatment. The prevalence of disease is often underestimated, however it is believed to affect at least 1 in 10 women in the UK. Within the NHS, endometriosis costs the UK economy approximately £8.2 billion a year in treatment, loss of work and healthcare costs.

Currently, the first diagnostic recommendation for endometriosis is and Ultrasound (US) scan or a MRI, followed by a diagnostic surgery called laparoscopy. Accurate diagnoses is usually limited to specialist tertiary centres, therefore a delayed diagnosis is a significant problem for women with endometriosis. Limited experience in the disease area can also lead to misdiagnosis and the latest report from the National Institute of Clinical Excellence (NICE) reports a time delay of around 7.5 years before a confirmed diagnosis of endometriosis. A model that could accurately predict surgical findings of endometriosis would be of significant clinical and economical benefit.

The main aim of this study is to curate a database of patients with varying levels of endometriosis. This database will contain fully anonymised MR and US images alongside clinical data for further use in research. There will be no intervention outside of standard of care. US and clinical data will be collected during routine visits and patients will be offered an additional visit to have a MRI. The ultimate aim is to then use this data to develop a widely available diagnostic tool based on MRI and US imaging modalities using computer modelling. Validating the predictive model with surgical findings will increase confidence and access to advanced imaging for non-experts, allowing clinicians to accurately predict surgical findings as well as reduce time to diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Women aged between 18-40 years
* Clinically diagnosed endometriosis and awaiting surgery
* BMI 20-35 kg/m2
* No past abdominal surgical history
* Participant willing and able to give informed consent for participation in the study

Exclusion Criteria:

* Previous surgery in 12 months prior to consent:

  * abdominal surgery
  * surgery for endometriosis
* The participant may not enter the study if they have any contraindication to magnetic resonance imaging (standard MR exclusion criteria including pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia).
* Any other cause, including a significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the participant's ability to participate in the study.
Expanded Access for IMMU-132

This is an expanded access program (EAP) for eligible participants designed to provide access to IMMU-132.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
Validation of a New Simplified Scoring System for Acute Calculous Cholecystitis

Acute calculous cholecystitis (ACC) is the second most frequent surgical condition in emergency departments. The recommended treatment is surgical treatment (ST) and the accepted mortality is \<1%, but in severe and/or fragile patients is higher. Despite the Tokyo Guidelines, there no consensus on who is the unfit patient for ST. A recent study has identified 4 risk factors that predicts the mortality in a 92% of patients (ACME) and could help to develop new guidelines in ACC. The aim of this study is this validation of the new simplified scoring system for mortality in ACC.

This is a retrospective single-center observational study of 387 adults with ACC during 2 non-consecutive years (2017/2021), including baseline demographic characteristics, comorbidity severity defined as Charlson Comorbidity Index (CCI), ASA Score, Tokyo Guidelines' severity classification and the new ACME Score. The primary outcome is to study the prediction of mortality of ACME score. Secondary outcomes include complications following Clavien-Dindo's classification, C-statistic, and ROC Curves.

Eligibility Criteria:
Inclusion Criteria:

* The selected patients were among those who had acute cholecystitis according to the TG18 or received a diagnosis of ACC in the histopathological report.

Exclusion Criteria:

* The study case definition was a "Pure ACC", therefore, patients with any other concomitant diagnosis potentially influencing outcome such as acute pancreatitis, acalculous cholecystitis, chronic cholecystitis, acute cholangitis, postoperative cholecystitis, gallbladder adenocarcinoma and those who had undergone cholecystectomy as a prophylactic measure in another intervention were excluded from the study.
Peptide Vaccine and Temozolomide for Metastatic Melanoma Patients

The aim of the study is to assess if treatment with IDO/Survivin peptide vaccine can enhance the efficacy of temozolomide chemotherapy in patients with metastatic malignant melanoma.

Secondarily to studying the efficacy of the treatment; the investigators examine if treatment with IDO/Survivin peptide can induce a measurable cellular T-cell response when the vaccine is given in combination with temozolomide treatment for melanoma patients.

Eligibility Criteria:
Inclusion Criteria:

1. Histological verified malignant melanoma
2. Metastatic disease (brain metastasis allowed if asymptomatic)
3. Evaluable disease recording to RECIST v. 1.1
4. Age \> 18 years
5. Performance status, PS=0, PS=1 or PS=2
6. Life expectancy \> 3 months
7. Adequate bone marrow function
8. Leucocyte count \> 2,5 \* 109/L
9. Granulocyte count \> 1,5 \* 109/L
10. Thrombocyte count \> 100 \* 109/l
11. Creatinine \< 2,5 \* UNL 130 micromol/L
12. Adequate liver function
13. ASAT \< 100 U/L
14. Bilirubin \< 300 U/L
15. S-hCG negative (fertile women)
16. Written informed consent
17. Inclusion at least 4 weeks after major abdominal surgery
18. If radiotherapy for brain metastases prior to inclusion, then progressive disease proven by new brain MR-scan before inclusion

Exclusion Criteria:

1. Treatment with immune suppressors (ie. prednisone) not allowed
2. Other malignancies 3 years prior to inclusion except benign skin lesions
3. Severe medical condition, severe asthma, severe COL, severe heart- or diabetic disease
4. Acute/Chronic infection with HIV, hepatitis or tuberculosis
5. Known severe allergic reactions
6. Former anaphylactic reactions
7. Active autoimmune diseases
8. Pregnant or nourishing women
9. Psychiatric disease resulting in non-compliance
10. Known allergic reactions towards Montanide, Imiquimod, Temozolomide or Leukine
11. Simultaneously treatment with other experimental drugs

Patients cannot be treated with chemotherapy, radiotherapy (except locally) or immunotherapy 14 days within inclusion.