cyrilzakka/clinical-trials huggingface dataset:
A Randomized Study of Amplimexon (Imexon) With Gemcitabine in Pancreatic Cancer

The purpose of this study is to determine if imexon in combination with gemcitabine could improve overall survival as compared to gemcitabine alone in subjects with pancreatic cancer that has spread to other organs such as the liver or lungs. The study will also look at the safety of the combination as compared to gemcitabine alone. Participants in the study will be randomly assigned to either treatment and neither the participant or their doctors will know which treatment they will be receiving.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically or cytologically confirmed, chemotherapy naive, metastatic pancreatic adenocarcinoma (Stage IV). This does not include patients with only locally advanced pancreatic cancer.
2. At least one unidimensional measurable metastatic lesion by contrast enhanced CT scan (or MRI in patients ineligible for contrast enhanced CT) that are outside any prior radiation port.
3. Age at least 18 years.
4. ECOG performance status 0 or 1.
5. No prior chemotherapy or radiation therapy.
6. Projected life expectancy at least 2 months.
7. If female, neither pregnant nor lactating.
8. If of child bearing potential must agree to, and be able to use adequate contraception.
9. Concomitant disease: No respiratory insufficiency requiring oxygen therapy; no angina at rest; no myocardial infarction in previous 3 months; no life threatening ventricular arrhythmias. No uncompensated CHF or NY Heart Association class 3 or 4 cardiac disease.
10. No other concurrent active malignancy.
11. No infection requiring parenteral antibiotic therapy at the start of protocol treatment.
12. Laboratory values within the following criteria:

    Hgb greater than or equal to 9 gm/dL WBC greater than or equal 3,500/mm\^3 ANC greater than or equal 1,500/mm\^3 Platelet count greater than or equal 100,000/mm\^3 Creatinine greater than or equal 2.0 Bilirubin less than or equal to 2.0 Hepatic enzymes (AST, ALT) less than or equal 3 times upper limit of normal (ULN)
13. G6PD level greater than or equal lower limit of normal (LLN).
14. Able to render informed consent and follow protocol requirements.

Exclusion Criteria:

1. Patients with locally advanced, non-metastatic pancreas cancer (Stage III or below).
2. Age less than 18 years.
3. ECOG performance status 2 or greater.
4. Prior anticancer drug therapy for metastatic disease.
5. Ascites.
6. Prior abdominal or thoracic surgery \< 4 weeks before the start of therapy.
7. Current or prior brain metastases. Brain MRI or CT required pre-registration only if the patient has CNS symptoms indicating a need for evaluation.
8. Life expectancy projected less than 2 months.
9. Pregnancy or lactation.
10. Unable or unwilling to utilize medically acceptable contraception if of childbearing potential.
11. Laboratory parameters outside of specified ranges, (see above).
12. Infection requiring parenteral antibiotics.
13. NY Heart Association stage 3 or 4 heart disease.
14. Unable to render informed consent.
15. Failure to meet any of the eligibility criteria as outlined above.
Haemochromatosis:Phlebotomy Versus Erythrocytapheresis Therapy

In this project we plan to evaluate the effectiveness of erythrocytapheresis against phlebotomy, both regarding the impact on the reduction in iron overload as well as reduction in patient "burden". Aspects of cost effectiveness will be included in the final analysis. Results of the study would allow decision-making based on Evidence Based Medicine on the "best" therapeutic options available for newly-diagnosed as well as existing primary hemochromatosis patients.

In this project we plan to evaluate the effectiveness of erythrocytapheresis against phlebotomy, both regarding the impact on the reduction in iron overload as well as reduction in patient "burden". Aspects of cost effectiveness will be included in the final analysis. The results of the study would allow decision-making based on Evidence Based Medicine on the "best" therapeutic options available for newly-diagnosed as well as existing primary hemochromatosis patients.

Eligibility Criteria:
Inclusion Criteria:

* Hereditary haemochromatosis patients

Exclusion Criteria:

* Malignancies, severe arrhythmias, congestive heart failure and/or recent angina, severe liver disease, epileptic seizures preceding in last 3 months before planned treatment
Docosahexaenoic Acid (DHA) Administration and Length of Gestation: a Feasibility Study

This is a feasibility study to determine if it will be possible to conduct a larger study of the effect of docosahexaenoic acid (DHA), an omega fatty acid, on increased length of gestation among women who have had a previous preterm delivery.

We propose to conduct an 18-month feasibility study to determine (a) how many women we could approach during a 4-month period, (b) how many of these women would be eligible for a future RCT, (c) how many would consent to participate in the RCT, and (d) how many would be subsequently rendered ineligible due to poor compliance. Women enrolled during the 4-month recruitment period would be followed until 1 month after delivery using telephone contact (for assessing compliance) and scanning of KPMCP electronic databases (for quantifying outcomes). We hope to enroll 50 to 75 women during our fixed time (4 months) recruitment period. Half of these 50-75 women would receive DHA; half would receive placebo.

We will identify potential subjects based on their response to the Preterm Birth Prevention Program questionnaire (a screening instrument administered by the Regional Perinatal Service Center \[RPSC\] to all women in the KPMCP entering prenatal care). Eligible women are those pregnant women entering prenatal care who, based on their response to the abovementioned RPSC questionnaire, are identified as having had a previous preterm delivery (delivery prior to 37 completed weeks of gestation).

Results of this study will (a) permit us to determine whether an RCT is feasible at a reasonable cost, and (b) assuming the answer to (a) is positive, it would then be possible for us to design an RCT that could address our primary study question.

Eligibility Criteria:
Inclusion Criteria:

* Previous preterm delivery (delivery prior to 37 completed weeks of gestation)

Exclusion Criteria:

* None
Clozapine Versus Olanzapine as Treatment for Comorbid Psychotic Disorder and Substance Use Disorder

The purpose of this trial is to determine if patients with comorbid psychotic disorder and substance use disorder will continue in treatment longer if treated with clozapine than with olanzapine, and will have greater reductions in psychosis and in substance use if treated with clozapine than treated with olanzapine. The specific aims and hypotheses of this trial are: 1. To compare the enduring effectiveness and tolerability of clozapine and olanzapine, as measured by time to all-cause treatment discontinuation, over 12 weeks of follow-up; The investigators hypothesize that patients assigned to clozapine treatment will have significantly longer times to all cause treatment discontinuation, 2. To compare the total psychosis items scores between patients treated with clozapine and patients treated with olanzapine over 12 weeks of follow-up; The investigators hypothesize that patients treated with clozapine will have significantly lower total psychosis items scores than patients treated with olanzapine, and 3. To compare the frequencies of positive urine drug screens and blood alcohol levels (obtained weekly throughout 12 weeks of follow-up) between patients treated with clozapine and patients treated with olanzapine; The investigators hypothesize that patients treated with clozapine will have significantly fewer positive urine drug screens and blood alcohol levels than patients treated with olanzapine.


Eligibility Criteria:
Inclusion Criteria:

* 18-60 years of age, male or female (post-menopausal, surgically sterilized, or receiving either one of the listed contraception - depot contraceptive, Intrauterine device, or implanted hormonal contraceptive),
* who meet DSM-V criteria for schizophrenia, schizoaffective disorder, bipolar disorder with psychotic features, depression with psychotic features, or delusional disorder, and have ratings of Moderate or greater on at least one of the Brief Psychiatric Rating Scale psychosis items,
* who meet DSM-V criteria for at least one of alcohol, marijuana, cocaine, stimulant, or opioid use disorder, and have an admission urine drug screen positive for at least one of these substances,
* who have a stable living situation (family or supervised living, e.g. personal care home) to return to after release into the community,
* and who provide signed informed consent to participate (after testing for comprehension).

Exclusion Criteria:

* Prior failure to respond or tolerate clozapine or olanzapine
* Logistics that prevent outpatient follow-up at Serenity Behavioral Health Adult Outpatient services
Effect of Chitosan-N-Acetylcysteine on IOL-power Prior to Cataract Surgery

Aim of this study is to evaluate the effect of treatment with Lacrimera® on calculated IOL power prior to cataract surgery and on the stability of ocular surface parameters compared to preservative-free, Hyaluronic-acid containing eyedrops (Hylo-Vision® sine).

The present study seeks to investigate the effect of treatment with Lacrimera® on the calculated IOL power prior to cataract surgery and on the stability of ocular surface parameters compared to preservative-free, Hyaluronic-acid containing eyedrops (Hylo-Vision® sine).

Eligibility Criteria:
Inclusion Criteria:

* Age older than 18 years
* Corneal staining (marked to severe; NEI grading scale \>=10)

Exclusion Criteria:

* Usage of eye drops other than lubricants (e.g. antibiotics, steroids, cyclosporin-A)
* Usage of systemic antibiotic therapy 7
* Any pathology of the ocular surface except dry eye disease (e.g. corneal scarring, cornea ectasia)
* Ocular surgery within prior 3 months
* Preceding refractive surgery (e.g. LASIK)
* Ocular injury within prior 3 months
* Ocular herpes of eye or eyelid within prior 3 months
* Active ocular infection
* Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months
* Eyelid abnormalities that affect lid function
* Ocular surface abnormality that may compromise corneal integrity
* Pregnancy and nursing women (in women of childbearing age a pregnancy test will be performed before inclusion into the study)
Art Therapy to Promote Wellbeing and Self-care in Resident Physicians.

This study evaluates if an art therapy intervention could lower resident physician's work-related stress and if it could promote their self-care.

The objective of this study is to determine if an art therapy intervention could promote the well-being of resident physicians of an university tertiary hospital, as specialized physicians trainees exposed to the risk of burnout.

Using a cycle of 6 bimonthly sessions of group art therapy, the intervention stimulates the creative activity of the participants through various art materials and techniques. Next, they are invited to share their reflexions about the artworks produced, with the group and in presence of the art therapist.

The study mainly evaluates the work-related stress and the self-care grade of the participants, before the intervention, just after it and after a follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* belonging to the resident physicians collective of the Santa Creu i Sant Pau Hospital.

Exclusion Criteria:

* being with a diagnostic of major depression
* receiving psychotherapy o similar
A Phase 1 Safety Study in Adults With Schizophrenia

This study will determine the safety, tolerability, and pharmacokinetics (PK) of olanzapine and samidorphan in adults with schizophrenia following 14 consecutive days of oral administration of ALKS 3831.


Eligibility Criteria:
Inclusion Criteria:

* Has a body mass index (BMI) of 18.0-35.0 kg/m\^2, inclusive
* Has a primary diagnosis of schizophrenia
* Capable of understanding and complying with the procedures, requirements, and restrictions of the protocol.
* Appropriate for outpatient treatment
* Agrees to abide by the contraception requirements specified in the protocol for the duration of the study or is surgically sterile
* Willing and able to provide government-issued identification
* Is in good physical health
* Agrees to maintain normal tobacco use as well as normal activities/exercise throughout the study
* Additional criteria may apply

Exclusion Criteria:

* Is currently pregnant or breastfeeding
* Initiated first antipsychotic treatment within the past 12 months, or \<1 year has elapsed since the initial onset of active-phase schizophrenia symptoms
* Poses a current suicide risk at Visits 1 or 2
* Has a history of poor or inadequate response to treatment with olanzapine
* Has used a long-acting injectable antipsychotic medication in the last 6 months with the exception of 3-month paliperidone, which must not have been received within the past 12 months.
* Requires or has had electroconvulsive therapy (ECT) treatment in the 6-month period prior to Visit 1
* Has a diagnosis of alcohol or drug use disorder (with the exception of nicotine)
* Has taken opioid agonists (codeine, oxycodone, tramadol, or morphine) within the 14 days prior to Visit 1 and/or anticipates a need to take opioid medication during the study period.
* Has taken opioid antagonists including naltrexone (any formulations) and naloxone within 60 days prior to Visit 1, or has used any extended-release formulation of an opioid antagonist within 2 months prior to screening
* Tests positive for amphetamines/methamphetamine, cocaine, barbiturates, opioids (codeine, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and buprenorphine), phencyclidine and benzodiazepines.
* Has a known or suspected intolerance, allergy or hypersensitivity to olanzapine or opioid antagonists.
* Additional criteria may apply
Study of the Effect of Etavopivat on Cerebral Hemodynamic Response in Children With Sickle Cell Disease

An open-label, single arm study in patients 12 to 21 years of age with SCD to evaluate the effects of etavopivat on cerebral and muscle hemodynamics.

This study is a pilot, open-label, single-arm study to evaluate the effect of etavopivat on cerebral hemodynamics, as measured by frequency domain near-infrared spectroscopy/diffuse correlation spectroscopy (FDNIRS/DCS) in participants 12 to 21 years of age with sickle cell disease (SCD). Cerebral blood flow (CBF), oxygen ejection fraction (OEF), and cerebral metabolic rate of oxygen (CMRO2) will be assessed FDNIRS/DCS in participants prior to, periodically throughout, and after 24 weeks of treatment with etavopivat. Approximately 12 participants will be enrolled.

The duration of study treatment will be 24 weeks. The study duration for individual participants may last up to 36 to 38 weeks and includes the Screening Period (up to 4 weeks before study treatment), the 24-week treatment period, a Safety Follow-up Visit at 4 weeks (+ 7 days) after the last dose of study drug, and an End of Study (EOS) visit approximately 8 weeks (± 7 days) after the last dose of study drug. A participant is considered to have completed the study if he or she has completed all phases of the study including the last visit or the last scheduled procedure shown in the Schedule of Events.

Eligibility Criteria:
Inclusion Criteria:

* Homozygous hemoglobin SS (HbSS) or hemoglobin S/beta0 thalassemia (HbS/β0 thal)
* Hemoglobin (Hb): Hb ≤ 9.0 g/dL at baseline
* Concomitant hydroxyurea (HU) therapy is allowed if the dose has been stable for at least 3 months with no anticipated need for dose adjustments during the study and no sign of hematological toxicity

Exclusion Criteria:

* Any one of the following requiring a medical facility visit within 14 days prior to signing the informed consent form:

  * Vaso-occlusive crisis (VOC)
  * Acute chest syndrome (ACS)
  * Splenic sequestration
  * Dactylitis
* Requires chronic transfusion therapy
* Abnormal TCD in the last 12 months
* RBC transfusion within 60 days of screening
* Severe renal dysfunction at the Screening Visit or on chronic dialysis
* Hepatic dysfunction
* Clinically relevant cardiac or pulmonary disease- e.g., congenital heart defect, uncompensated heart failure, or any unstable cardiac condition, arrhythmic heart condition, pulmonary fibrosis, pulmonary hypertension
* Major surgery involving the stomach or small intestine
* Chemotherapy or radiation within the past 2 years
* History of overt clinical stroke within previous 2 years or any history of an intracranial hemorrhage
* Clinically significant bacterial, fungal, parasitic, or viral infection currently receiving or that will require therapy
* Female who is breast feeding or pregnant
Technology Supported Education Program Based on Human Care Theory

Hematopoietic stem cell transplantation is applied in the childhood age group for many reasons such as hematological malignancies, immune deficiencies, hemoglobinopathies, bone marrow failures and congenital metabolic diseases. The transplantation process, which requires a long hospitalization process, is an experience that causes anxiety for the child and the caregiver.

It is known that during the home care process after discharge, parents experience anxiety because they are away from health professionals, and they need information and support in their care needs. This research has two purposes. 1; Developing a technology-supported home care education program (IBK-EBP) (supported by face-to-face education and mobile application) based on Human Theory of Care (IBK) for home care of children with hematopoietic stem cell transplantation. 2; It is to determine the effect of IBK-EBP education program on parents' knowledge, self-efficacy, anxiety level and quality of life. The study was planned in a single-center, follow-up, double-blind, randomized controlled design. The research sample was planned to be composed of 40 parents, 20 of which were interventions and 20 of which were controls. The home care training program, which will be prepared with up-to-date information in line with the literature; It includes face-to-face training sessions and ensuring the continuity of education at home with the mobile application to be developed. The content of the home care training program to be prepared in this context; regulation of the home environment, compliance with treatment, food safety, personal hygiene and care, social environment, planning of school life and progressive relaxation exercises. As part of the training program, parents will be shown a CD of progressive relaxation exercises before the training. Research data will be collected by a nurse other than the researchers, who was not involved in the study. Research data will be collected using the "Parent and Child Identification Form", "Parent's Knowledge Level of Care Assessment Form", "General Self-Efficacy Scale", "Quality of Life Scale for Caregivers of Cancer Patients" and "Spielberger State and Trait Anxiety Inventory". With a technology-supported home care education program to be developed based on the Human Care Theory it is predicted that the knowledge, self-efficacy, quality of life of the parents will increase and the level of anxiety will decrease, by ensuring the ease and continuity of access to information.

Eligibility Criteria:
Inclusion Criteria:

* Primary care parent of the child (0-18 years old) after HSCT
* Having mobile internet access
* Discharge planned

Exclusion Criteria:

* Parent's failure to attend at least 3 sessions of the training program
Long Term Follow-up for Hypospadias

Hypospadias is a frequent malformation. The definition of hypospadias is a ventral tissues hypoplasia, with an abnormal position of the urethral meatus, a chordee of the penis and an open foreskin. It can be associate with other genital malformation; in that case it can be classified in the wider field of the disorder of sex development (DSD). There is a lot of surgical technics for those malformations.

In the pediatric surgical department, in Lyon, three technics are the most used because of their reliability and their good outcomes in short and mid term.

This is essential for investigator to have a long term evaluation, with a physical exam and paraclinical exams, after the puberty, to assess the outcomes after the changes especially at the puberty.


Eligibility Criteria:
Inclusion Criteria:

* Male patients
* with previous hypospadias surgery,
* Birthday before December the 31th 2009.
* The surgery was performed by one operator, with the following surgical technics: Koff, Onlay and Koyanagi.
* The patients are informed by an official surgery department letter, to assure they agree to participate.
* if the patient is still an infant, the parental agreement will be necessary.

Exclusion Criteria:

* Patient deceased
* Non- agreement from the patient or his parents
* Language difficulties
Seroprevalence Study to Evaluate the Persistence of Anti-leptospira Antibody in Subjects Vaccinated With Spirolept® Vaccine

The study aims to assess antibody persistence induced by Spirolept® vaccination in subjects who received at least 4 doses (2 doses two weeks apart and 2 booster doses) and no more than a total of 8 doses (2 doses two weeks apart and 6 booster doses).

This is a seroprevalence, phase IV, multi -center study to evaluate anti-Leptospira antibody persistence in subjects who have received at least the 2nd booster (4 vaccine doses) and no more than the 6th booster (8 vaccine doses) of Spirolept® vaccine.

The study will be conducted at the Occupational Health Centre of companies employing workers at risk of leptospirosis for their occupational activities. Study participants will be selected from the company Occupational Health Centre database where each employee is registered. All workers are regularly followed-up and their medical and vaccination history recorded. Subjects selection will occur according the number of booster doses received (having received at least the 2nd booster and no more than the 6th booster). After they have signed the informed consent form, subjects will be recruited into the study and if all inclusion and exclusion criteria are met they will be taken a blood sample.

Anti-leptospira IgG antibody will be measured by a validated ELISA. Other assay may be performed to further characterize anti-leptospira antibodies. Data on subject demographics, relevant medical history, vaccination dates, and blood collection will be recorded in an appropriate Case Report Form.

The study does not include any vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Adults of both genders aged 18 to 65 years
* High risk occupational subjects to leptospirosis having received at least 4 (2 initial doses and 2 booster doses) and no more than 8 (2 first doses and 6 booster doses) doses of Spirolept®
* Previous Spirolept® vaccination dates documented
* To be affiliated to a health insurance plan
* Having signed the informed consent form

Exclusion Criteria:

* Had an acute infection during the 3 weeks before study enrollment
* Subject with documented HIV or hepatitis A, B, C
* Immunosuppressive treatment (chemotherapy, corticosteroids \> 20mg/day, biological agents)
* Subject with progressive malignancy requiring specific treatment
* Previous documented Leptospirosis