cyrilzakka/clinical-trials huggingface dataset:
Safety, Tolerability and Pharmacokinetics of CSL360 in the Treatment of Acute Myeloid Leukemia

Acute myeloid leukemia (AML) is a heterogeneous group of diseases characterized by uncontrolled proliferation of the myeloid line of white blood cells and impaired production of normal blood cells. If untreated, patients die of infection or bleeding usually in a matter of weeks. CSL360 is a neutralising monoclonal antibody which is believed to target the cells that are thought to drive AML but that are not effectively killed by standard treatment. The aims of the study are to determine a biologically active dose of CSL360 and generate understanding of a rational schedule of administration for future studies.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of acute myeloid leukemia
* Recent bone marrow biopsy
* Prior treatment or medically unfit for standard therapy

Exclusion Criteria:

* Peripheral blood blast count \> 30 x 109/L, or rapidly progressive AML
* Previous solid organ transplant
* Active GvHD or immunosuppression
* Concurrent treatment with other anti-cancer therapy
* Active infections
Weekly Antepartum Testing in Women With BMI 30-40 and Neonatal Outcomes

The purpose of study is to evaluate whether weekly antenatal testing in pregnant women with body mass index (BMI) 30-40 in the third trimester is associated with earlier delivery when compared to growth ultrasounds every 4 weeks. The investigators will also assess the differences in maternal and neonatal outcomes between the groups.

Over the last decade, the prevalence of obesity has dramatically increased in women in reproductive age. It is well known that obesity has been associated with increased risk of antenatal complications, maternal and perinatal morbidity, including higher risk of stillbirth. Studies including obese women without other antepartum comorbidities have shown that up to 11% of pregnancies are complicated with fluid and fetal growth abnormalities. According to American College of Obstetricians and Gynecologists (ACOG) guidelines, antepartum surveillance has not been proven to improve pregnancy outcomes in such cases and no specific recommendations for antepartum surveillance in obese women have been established.

Eligibility Criteria:
Inclusion Criteria:

* Women at or over 18 years of age
* Singleton pregnancy with no major fetal anomalies
* Pregnancies and gestational age will be well dated
* Obese with BMI 30-40kg/m2

Exclusion Criteria:

* Women with any complications at time of randomization that would require antenatal testing in the third trimester as per ACOG guidelines including: hypertension, systemic lupus erythematosus, chronic renal disease, antiphospholipid syndromes, hyperthyroidism poorly controlled, hemoglobinopathies, cyanotic heart disease, gestational hypertension, pre-eclampsia, gestational diabetes medication controlled, oligohydramnios, intrauterine growth restriction before randomization, isoimmunization, history of fetal demise
* Women with indication for weekly testing as per local protocol
Validation of PRISM-5-Op, Measure Of Addiction To Prescription Opioid Medication

The purpose is to validate the PRISM-5-Op as a measurement of prescription opioid substance use disorder.

"Based on a review of the literature, the Food and Drug Administration (FDA) concluded that more data are needed regarding the serious risks of misuse, abuse, addiction, overdose, and death associated with the long-term use of extended release/long acting (ER/LA) opioid analgesics. Thus, the FDA is requiring that ER/LA opioid analgesic drug sponsors conduct post-marketing studies to assess these risks. The present study, PMR Study #2065-2, focuses on addiction, and addresses the FDA requirement to conduct a validation study of the measure of addiction that will be used in PMR Study #2065-1.

The primary objective for Study 2b is to validate PRISM-5-Op measures of DSM-5 prescription opioid SUD/addiction in patients who have, or have had, a prescription for opioids for at least 30 days to treat chronic pain"

Eligibility Criteria:
Inclusion Criteria:

1. Has or has had a prescription for opioids for chronic pain for at least 30 days
2. Age 18 years or older and English-speaking
3. Willing and able to provide informed consent"

Exclusion Criteria:

1. Patient has a hearing or vision impairment that would preclude an interview or completion of self-administered questionnaires
2. Patient too cognitively impaired to give informed consent or participate in the evaluations.
Predicting Complications of Hepatolithiasis After Hepatectomy

Postoperative complications seriously affect the recovery of patients undergoing hepatectomy. Identifying risk factors and develop predictive models of complications for patients with hepatolithiasis undergoing hepatectomy is important for clinical practice.

Along with the change of lifestyle and dietary habits, many people are diagnosed with hepatolithiasis that is especially prevalent in Asia. Liver resection remains the favorable curative therapy for hepatolithiasis with a relatively low recurrence rate. Although there have been great improvements in surgical techniques and perioperative management, postoperative complications remain commonplace and seriously threat the recovery of patients undergoing hepatectomy. Therefore, it is important to identify risk factors of complications to improve the overall prognosis of patients. We want to collect the clinical information of patients with hepatolithiasis undergoing hepatectomy, including demographic data , laboratory index, histological features and postoperative complications. Patients are followed up at a interval of 3 month after treatment, and the survival data and recurrence rate are recorded. Then the relationship between clinical data and short-term outcomes after surgery are explored. Then models based on clinical features are developed to predict short-term outcomes after hepatectomy.

Eligibility Criteria:
Inclusion Criteria:

* pathologically diagnosed hepatolithiasis
* without malignancies
* receiving liver resection
* Eastern Cooperative Oncology Group performance status (ECOG-PS) 0-2
* Child-Pugh score of ≤7
* complete clinical and follow-up information
* age between 18-80 years old

Exclusion Criteria:

* with malignancies
* receiving other treatments
* Eastern Cooperative Oncology Group performance status (ECOG-PS) \>2
* Child-Pugh score of \>7
* incomplete clinical data
* lost to follow up
* age \<18 years old or \>80 years old
Impact of FOLFIRINOX Chemotherapy in IV Stage Colorectal Cancer Patients Previously Exposed to Irinotecan, Fluoropyrimidine and Oxaliplatin

The purpose of this work is to verify prospectively what the rate of response after triple chemotherapy with mFOLFIRINOX in patients in IV stage of Colorectal Cancer who have already failed after at least two lines of dual combinations with fluoropyrimidine, oxaliplatin, irinotecan and anti-EGFR if wild-type RAS.

Currently at ICESP, patients are frequently re-exposed in third line to double combinations.

Single-arm phase II study. The chemotherapy regimen with mFOLFIRINOX will be administered every 14 for 4 cycles, after evaluation of tumor response, you can maintain treatment until disease progression.

The FOLFIRINOX regimen, as well as the drugs used (oxaliplatin, 5-Fluorouracil, leucovorin and irinotecan) is already indicated in the package insert for the treatment of colorectal cancer.

If treatment is discontinued after cycle 4 with the patient responding, for response maximum or unmanageable toxicity, it is suggested to maintain imaging control every 60 days (7-day window) until disease progression. This interval is already commonly used for patients with metastatic disease who are on treatment pause. Treatment in progression of illness will be at the discretion of the treating physician. Cancer patients undergoing chemotherapy routinely perform evaluation of organ functions and CEA, as well as clinical evaluation before each cycle of treatment

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of metastatic colon/rectal adenocarcinoma, with measurable by RECIST v. 1.1
* Disease progression to at least two lines of chemotherapy with chemotherapy regimens that contain fluoropyrimidine, irinotecan and oxaliplatin
* Patients with RAS research in tumor sample with result wild animals must have previously received anti-EFGR therapy.
* ECOG (Eastern Cooperative Oncology Group) 0 or 1
* Availability of tumor material for molecular analysis
* Hb \> 8, neutrophils \> 1,500 and PLQ \> 100,000
* Adequate kidney and liver function

Exclusion Criteria:

* Active neoplasm with other primary site, except in situ tumors
* Contraindication to treatment with fluoropyrimidine, oxaliplatin and irinotecan, including previous unmanageable G3 or greater toxicities, in previous exhibitions.
* Presence of comorbidities that, according to the investigator's assessment, may compromise participant safety
* Prior exposure to the FOLFIRINOX regimen
* Pregnant or lactating women
* Total bilirubin above 1.5mg/dL
* Hepatic transaminases greater than 3 times the upper limit of normality
Transcranial Treatments in Eating Disorders

The primary aim of this study is to study how Repetitive Transcranial Magnetic Stimulation (rTMS) tailored to specific anorexia nervosa (AN) or bulimia nervosa (BN) brain activation alterations will promote recovery and to study how inhibitory tDCS (Transcranial Direct Current Stimulation) will reduce symptoms of body image distortion in a second sample of AN and BN groups.


Eligibility Criteria:
Inclusion Criteria:

* Anorexia Nervosa subjects:
* Meets DSM-5 criteria for anorexia nervosa (AN) either binge-eating/purging type or restricting-type:
* Intense fear of gaining weight or becoming fat, even though underweight.
* The ability to undergo an MRI, fMRI or other similar procedure requiring spending time in an enclosed space
* Bulimia Nervosa subjects:
* Meet DSM-5 criteria for bulimia nervosa (BN):
* Self-induced vomiting; misuse of laxatives, diuretics, enemas, medication, fasting, excessive exercise.

Exclusion Criteria:

* Electrolyte, blood count or kidney or liver function abnormalities.
* No symptoms of alcohol or other substance abuse or dependence in the past 3 months,
* No previous or current organic brain syndromes, dementia, psychotic disorders, somatization disorders, or conversion disorder, head trauma, indication of mental retardation or pervasive developmental disorder.
* No antipsychotics, tricyclic antidepressants or Wellbutrin or other medication that may lower the seizure threshold.
* Claustrophobia.
A Non-Interventional Pilot Study to Explore the Skin Microbes in Skin Cancer

This study seeks to correlate microbial sequencing data from a punch biopsy in patients with skin cancer both melanoma and non-melanoma.

The human Skin microbiome is a complex, interconnected web of microbes, living in a symbiotic relationship with their host. There are greater than ten times more bacteria on our bodies than there are human cells, all in a delicate and ever-changing balance to maintain a healthy skin microbiome. When this balance is disrupted, a condition known as dysbiosis, disease can occur. There is still a debate over whether dysbiosis is a cause of disease or a symptom of it. Naturally, since the microbiome has such a profound impact on human health, we want to study and learn as much about the microbiome as possible. By correlating this data with medical records for the patient's skin cancer, connections may begin to be drawn between organisms present in the microbiome of the skin microbiome, and skin cancer. Much like fingerprints, no microbiome is identical therefore the only chance we have at understanding disease is by looking at the skin microbiome and comparing the microorganisms on a patient with skin cancer biopsy and non-skin cancer biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* 18 years of age or older
* Diagnosis of skin cancer, both melanoma and non-melanoma
* Able/willing to have a skin punch biopsy in a non-cancerous location

Exclusion Criteria:

* Unable/unwilling to sign informed consent
* Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study.
Improving Glycemic Control on GMS: A Quality Improvement Study

This study will examine whether new processes and technologies for monitoring diabetic patients' insulin levels improves patient care at Brigham and Women's Hospital.

This study will examine whether new processed and technologies for monitoring diabetic patients' insulin levels improves patient care. Patients at Brigham and Women's Hospital (BWH), staying on the General Medicine Service, who have Type 2 diabetes and who are not on IV insulin can participate in this study. Physicians and nurses will be taught new rules to care for diabetic patients, while in the hospital. Also, the BWH computer system will be updated to include these new rules for administering insulin. Patients who participate in the study will be randomly placed into one of two groups: one group that will be cared for by physicians and nurses who have learned these new rules for administering insulin; or the second group, who will receive diabetes care at BWH before the new rules were adopted. The study will last approximately 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will include all type 2 diabetic patients on the General Medicine Service (GMS) of Brigham and Women's Hospital (BWH) who do not have an indication for IV insulin.

Exclusion Criteria:

* Type 2 diabetic patients on the General Medicine Service (GMS) of Brigham and Women's Hospital (BWH) who have an indication for IV insulin.
Prospective Study of the Natural History of Patients With Type 2 and 3 Spinal Muscular Atrophy

NatHis-SMA is a prospective, longitudinal and interventional study of the natural history of patients with type 2 and 3 Spinal Muscular Atrophy (SMA). The purpose of this study is to characterize the disease course over 2 years and identify prognostic variables of the disease and biomarkers of SMA progression, as well as determine the best outcome measures for further therapeutics approaches.


Eligibility Criteria:
INCLUSION CRITERIA

* Type 2 or 3 spinal muscular atrophy genetically confirmed
* Age superior or equal to 2 years old up to 30 years of age included
* For patients older than 6 years old, willing and able to comply with all protocol requirements and procedures.
* For non-ambulant patients, able to sit upright in a wheelchair for at least three hours
* Patients over 18 years of age and parent(s)/legal guardian(s) of patients \< 18 years of age must provide written informed consent prior to participating in the study and informed assent will be obtained from minors at least 7 years of age when required by regulation.
* In France only: Affiliated to or a beneficiary of a social security category

EXCLUSION CRITERIA

* Previously treated with an investigational drug within 6 months prior the recruitment in this study.
* Other condition which may significantly interfere with the assessment of the SMA and is clearly not related to the disease
* Current or anticipated participation in any therapeutic investigational clinical studies.
* Patients with specific contraindication to MRI (i.e. metallic foreign body, claustrophobia, and others deemed to be prohibitive by the investigators) will be allowed to participate, but MRI will not be performed.
* For women : pregnancy or current breastfeeding
A Comparative Safety and Activity Study With Ferroquine Associated With Artesunate Versus Amodiaquine Associated With Artesunate in African Adult Patients With Uncomplicated Malaria

The primary objective is to assess the safety of different doses of ferroquine with artesunate (AS) in adult African patients with uncomplicated malaria.

The secondary objectives are to assess activity in reducing parasitemia and the pharmacokinetics of ferroquine and its metabolites.

The study duration is 30 days including a 2 day screening period, a 3 day treatment period with a follow-up period of 25 days. Patients remain hospitalized 4 days.

Eligibility Criteria:
Inclusion Criteria:

* Body weight between 50 kg and 90 kg with Body Mass Index \>18 kg/m²
* Presence of body temperature ≥ 37.5°C or history of fever within the last 24 hours
* Monoinfection with Plasmodium falciparum and parasitemia within the 100 to 200,000/microL

Exclusion Criteria:

* Hypersensitivity to quinoleines or artesunate
* History or presence of any clinically significant disease or symptoms which, in the judgment of the investigator, might confuse the interpretation of the safety and efficacy information
* Splenectomized patients
* Laboratory parameters outside normal ranges
* Presence of HBs antigen, anti-HCV antibodies and anti-HIV 1\&2 antibodies
* Cardio vascular and Electrocardiogram parameters outside normal values
* Presence of criteria of complicated malaria
* Permanent vomiting
* Previous treatment within 5 times the elimination half-life of any anti-malaria agents or with any marketed or investigational drugs (including St John's Wort) within 14 days before administration, or within 5 times the elimination half-life of that drug, whichever the longest, especially CYP3A and 2D6 main substrates
* Positive results on urine drug screen for anti-malaria agents (aminoquinolines)
* History of drug or alcohol abuse (alcohol consumption \> 40 grams/day ; i. e. 2.5 beers of 33cl with 5 degrees of alcohol)
* Intention to use herbal medicine during the study period
* Immunization injection within last 15 days

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Expanded Access Program of Taletrectinib in Patients with Advanced or Metastatic ROS1-Positive NSCLC

This Expanded Access Program will provide access of taletrectinib therapy to patients with locally advanced or metastatic ROS1-positive NSCLC who are not an appropriate candidate for an approved therapy, for any ongoing taletrectinib clinical trial and who, in the opinion of their oncologist, may benefit from treatment.

This Expanded Access Program will provide access of taletrectinib therapy to patients with locally advanced or metastatic c-ros-oncogene 1 (ROS1)-positive non-small cell lung cancer (NSCLC). These patients are not an appropriate candidate for an approved therapy, including crizotinib, entrectinib, or repotrectinib, for participating in ongoing Nuvation Bio clinical trial AB-106-G208 and who, in the opinion of their oncologist, may benefit from treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Histologically or cytologically confirmed diagnosis of locally advanced (including inoperable Stage IIIA or IIIB NSCLC) or metastatic NSCLC.
* Evidence of ROS1 gene fusion.
* Adequate bone marrow and organ function
* Ineligible for participation in ongoing Nuvation Bio clinical trial AB-106-G208. Exception may be granted by the Sponsor/Supplier if they have a restriction or hardships that prevent them from participating in a clinical trial.
* Failed approved therapy or are not an appropriate candidate for an approved therapy including crizotinib, entrectinib, or repotrectinib.

Exclusion Criteria:

* Prior systemic anticancer therapy washout of 5 half-lives or 2 weeks, whichever is sooner.
* Patients who develop acute medical conditions which require immediate treatment or stabilization (e.g., new diagnosis of pulmonary embolism that requires anti-coagulation; acute and symptomatic spinal cord compression that requires immediate spinal radiotherapy). Note: patients may enroll after starting treatment for these acute conditions and the patients are considered stabilized.
* History or evidence of interstitial fibrosis, interstitial lung disease or drug-induced pneumonitis that did not resolve prior to screening.
* Active and untreated hepatitis B or C. Exception is chronic stable hepatitis B and C with stable liver function at screening.
* Ongoing cardiac dysrhythmias of Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 2, uncontrolled atrial fibrillation of any grade, or QT interval corrected for heart rate by Fridericia's formula \>470 milliseconds, or symptomatic bradycardia \<45 beats per minute; patient has family or medical history of long QT syndrome.
Construct Validity and Reliability SCALE

The aim of the study was to determine construct validity, discriminant validity and intra- and interrater reliability of the Selective Control Assessment of the Lower Extremity ( SCALE).


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of spastic cerebral palsy,
* age between 4 and 18 years,
* ability to follow simple instructions.
* ability to walk (GMFCS levels I-IV),

Exclusion Criteria:

* unstable situation regarding their tonus-regulating medications
* orthopedic intervention or surgical correction within the last year,
* botulinum toxin injection within the last 6 months
Outcomes After Laparotomy for Penetrating Abdominal Trauma

The purpose of this study is to evaluate outcomes of adult patients hospitalised due to penetrating abdominal trauma at a tertiary trauma hospital in South Africa. Our primary objective is to study the association between waiting time to surgery and outcome (mortality, complications, and length of hospital stay) in normotensive patients treated with laparotomy for penetrating abdominal trauma.


Eligibility Criteria:
Inclusion Criteria:

* Patients that are admitted due to penetrating abdominal injuries, irrespective of injury mechanism, time from injury and prior treatment.
* Patients that are treated with laparotomy.

Exclusion Criteria:

* Patients that are admitted due to blunt trauma or combinations of blunt and penetrating trauma.
* Patients who are dead on arrival.
* Patients that are only re-admitted during the study period, i.e. patients that received primary treatment by TBH before study initiation.
Systematic Intervention to Improve Sexual Dysfunction

The aim of this clinical trial is to compare the benefit of early, systematic, multidisciplinary oncosexological care versus on-demand care on the sexual health of women with breast cancer.

The aim of the study is to evaluate the effectiveness of early, systematized oncosexology care on perceived sexual health at 18 months, compared with oncosexology care on demand.

All included patients are evaluated at Baseline and M18 following initiation of antineoplastic treatments associated with surgery. Patients who accepted additional oncosexological care were also assessed at M4, M8 and M12. The content of support care is detailed in section "arms and interventions".

Oncosexology consultations with the sexologist and the medical support care of any organic disorders remain accessible to all patients, on request, including the group of patients who do not wish to participate in early and systematic oncosexology care.

Eligibility Criteria:
Inclusion Criteria:

* Women ≥ 18 years (menopausal or not),
* Localized breast cancer with or without lymph node involvement,
* Initial treatment starting with surgical resection, whatever the associated therapy (chemotherapy, radiotherapy, hormone therapy, monoclonal antibody, conjugated drug antibody, targeted therapy such as cyclin and anti-PARP inhibitors, etc.),
* Patient affiliated or benefiting from the social security system,
* Patient informed and informed consent signed.

Exclusion Criteria:

* History of cancer (except squamous cell carcinoma or basal cell carcinoma) in the last five years,
* Pregnant or breast-feeding women,
* Patients deprived of their liberty, under guardianship or curatorship and all other administrative safeguards,
* Patients unable to comply with the study schedule for social, medical or psychological reasons.