cyrilzakka/clinical-trials huggingface dataset:
Eribulin [Halaven] Use For the Treatment of Advanced Breast Cancer

The purpose of this study was to evaluate the efficacy and safety of eribulin in standard clinical practice in patients with locally recurrent or metastatic advanced breast cancer.

This was an observational, cross-sectional, retrospective, multicenter study conducted in Spain. During the year after authorization of the drug by the European Medicines Agency (EMA), patients in the compassionate use program (public sites) and patients treated in private sites (no purchase restrictions) who received at least 1 dose of treatment with eribulin per approved label at any of the 17 Spanish sites with the highest numbers of treated cases during that period (minimum 3 patients/site) were enrolled in this observational study. Approximately 112 patients will be enrolled in the study.

Eligibility Criteria:
Inclusion criteria:

1. Patients diagnosed with locally recurrent or metastatic advanced breast cancer, previously treated with taxanes and anthracyclines, unless these were not indicated.
2. Clinical and/or radiological documentation of location and extension of the disease at the time of starting treatment with eribulin. Patients with measurable diseases and those patients who only have non-measurable lesions are eligible.
3. Medical history documentation including analytical control data (blood count and serum chemistry including hepatic and renal functions) carried out at least one week before starting treatment with eribulin. (Determining the CA15-3 tumor marker is not indispensable).
4. Eribulin monotherapy (at least 1 dose) between April 2011 and March 2012, both inclusive.
5. Availability of a medical history allowing monitoring of clinical progression of the patients during and after treatment with eribulin.

Exclusion criteria:

1. Diagnosis of any type of cancer in the last 5 years, except for non-melanoma skin cancer, cervical intraepithelial neoplasia or contralateral breast cancer.
2. Patients having received any other anti-tumor treatment, whether conventional or experimental, during the week prior to starting treatment with eribulin. Treatment with bisphosphonate and corticoids is allowed if they are clinically indicated and started 28 days before treatment with eribulin.
3. Lack of clinical status documentation after completing treatment with eribulin or, at least, after having been administered 3 initial cycles. This can arise in any of the following cases (they are not excluding):

   1. Patients whose Medical History does not state the reason and date for interruption of treatment with eribulin and their subsequent clinical progression.
   2. Patients still undergoing treatment with eribulin on March 31, 2012, for whom there is no data for at least the first 3 cycles.
Acamprosate in Youth With Fragile X Syndrome

Fragile X syndrome (FXS) is the most common inherited form of developmental disability. FXS is inherited from the carrier parent, most often the mothers. FXS is associated with severe interfering behavioral symptoms which include anxiety related symptoms, attention deficit hyperactivity, and aggressive behaviors. Approximately 25-33% of individuals with FXS also meet criteria for autistic disorder. The hypothesis of this study is that treatment with acamprosate will reduce inattention/hyperactivity, language impairment, irritability, social deficits, and cognitive delay in youth with FXS. The purpose of this study is to investigate the effectiveness and tolerability of acamprosate in youth with Fragile X Syndrome and to assess the potential psychophysiological differences between FXS and autism spectrum disorders.


Eligibility Criteria:
Inclusion Criteria:

* Male and female outpatients between the ages of 5 and 17 years.
* Confirmed diagnosis of Fragile X Syndrome based upon genetic testing.
* Stable dosing of all psychotropic medications for at least 2 weeks prior to baseline.
* Subjects with a stable seizure disorder or history of only childhood febrile seizures will be included.
* Clinical Global Impression-Severity Score of 4 (Moderately Ill) or greater.
* Must be in good physical health.
* Subjects of child bearing age of both genders will be required to utilize birth control as applicable.

Exclusion Criteria:

* Diagnosis of schizophrenia, another psychotic disorder, bipolar disorder or alcohol or other substance abuse based on Diagnostic and Statistical Manual Fourth Edition-Text Revised (DSM-IV-TR).
* A significant medical condition such as heart, liver, renal or pulmonary disease or unstable seizure disorder.
* Females with a positive urine pregnancy test
* Creatinine clearance of less than 30.
* Concomitant use of another glutamatergic agent (memantine,riluzole, d-cycloserine, amantadine topiramate, gabapentin, among others.
* Evidence of hypersensitivity to acamprosate or potentially serious adverse effect.
* Subjects who, in the opinion of the investigator, are unsuitable in any other way to participate in this study including being unable to comply with the requirements of the study for any reason.
Safety and Efficacy Study of NVC-422 on Bacteriuria in Catheterized Patients

The purpose of this clinical trial is to study the effects of NVC-422 instilled into the bladder in reducing bacteria in the urine.

Catheter-associated urinary tract infection (CAUTI) is a major healthcare problem in the U.S., accounting for approximately 40% of all hospital acquired infections. Microorganisms can colonize the catheter extraluminally or intraluminally, and are often protected in a biofilm environment. Nearly all patients catherized for 30 days or longer will develop bacteriuria, or the presence of bacteria in normally sterile urine. Ten to twenty percent of these patients will develop a symptomatic CAUTI. In a further 1-4%, the infection will spread into the kidneys or bloodstream, leading to potentially lethal bacteremia.

Currently, there is no bladder irrigation solution that can reduce or eliminate CAUTI. A bladder instillation solution that can keep the bladder and catheter substantially free of bacteria and biofilm is expected to provide a practical and cost-effective means of minimizing CAUTIs.

NVC-422 is a topical, non-antibiotic, fast acting, broad spectrum anti-microbial, which exhibits potential for the rapid decolonization of a range of urologic pathogens, including Escherichia Coli (E. coli), Enterococcus spp., P. mirabilis and others. In vitro studies with NVC-422 have also shown that it is capable of penetrating a biofilm and effectively killing the contained microbes.

Eligibility Criteria:
Inclusion Criteria:

* Patients or their guardians are willing and able to provide informed consent
* Age \> 18 years
* Condition requiring chronic transurethral catheterization for at least 1 month prior to enrollment
* Indwelling transurethral catheter not scheduled for exchange for at least 1 week from first treatment
* Documented asymptomatic bacteriuria as defined in the protocol
* Vital signs within the following limits: blood pressure 90 to 160 mm Hg systolic and 50 to100 mm Hg diastolic, pulse rate 45 to 100 bpm, respiratory rate 8 to 24 respirations per minute, oral body temperature 35.5ºC to 38.0ºC
* Screening must occur within 14 days of enrollment into the study

Exclusion Criteria:

* Unwillingness/inability to fulfill the requirements of the study
* History of hepatitis B or C, HIV, AIDS, or other immunodeficiency disease
* Systemic antibiotics within 7 days of enrollment
* Any condition that, in the opinion of the principal investigator, would make the subject unsuitable for the study or place the subject at additional risk.
* Any investigational drug or investigational device within 30 days of enrollment in the study
* Women who are pregnant or lactating; or of child-bearing potential unless using highly effective birth control method for 1 month prior to and during the study
Cyclosporine in Patients With Moderate COVID-19

Phase 1 safety study to determine the tolerability, clinical effects, and changes in laboratory parameters of short course oral or IV cyclosporine (CSA) administration in patients with COVID-19 disease requiring oxygen supplementation but not requiring ventilator support.

Our overall hypothesis is that CSA is safe in this patient population and that it will have antiviral and anti-cytokine effects as measured in laboratory tests.

The initial dose will be 9 mg/kg/day oral divided q12h or 3 mg/kg/day by continuous IV infusion. Oral administration is generally preferred, however IV administration can be used if oral administration is not feasible or cannot be tolerated, or at the physician-investigator's clinical discretion. The dose will be adjusted to target a trough level of 200 to 300 ng/ml, which is in alignment with common clinical practice. The planned duration of CSA treatment is up to 14 days, with planned discontinuation upon discharge from the hospital. Dose reduction of 25% to 50% can be made for patients who experience adverse events such as hypertension or serum creatinine elevation.

The end of study will be study day 30 for those patients who have been discharged from the hospital. If the patient remains in the hospital, the subject will still complete the end of study visit at day 30 as planned, but will continue to be followed until date of discharge.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged \>18.
4. Admitted to hospital with laboratory confirmation of SARS-CoV-2 infection.
5. Estimated creatinine clearance \>50 ml/min using standard Cockcroft-Gault formula.

Exclusion Criteria:

1. Are admitted to the ICU at time of enrollment.
2. Have an active uncontrolled infection with a non-COVID-19 agent.
3. Have an active malignancy, not including non-melanoma skin cancer, superficial cervical or bladder cancer, MGUS, or prostate cancer with PSA \<1.0.
4. Are on chronic immune suppressive medications, including
5. corticosteroid therapy at a prednisone equivalent dose of 10 mg per day or higher; therapy with calcineurin inhibitors or mTOR inhibitors.
6. Are pregnant
7. Are lactating
8. Have a known allergic reaction to components of the CSA or its diluents.
9. Are receiving investigational vaccine for SARS-CoV-2.
Hepatocellular Carcinoma Treated With Iodine-125 Implantation

To prospectively evaluate whether use of combined radiofrequency ablation (RFA) and percutaneous iodine-125 (125I) seeds implantation results in better survival compared with use of RFA alone in patients with hepatocellular carcinoma.

This study was local ethical committee approved; all patients gave written informed consent. A total of 136 patients were randomly assigned to undergo RFA-125I (n = 68; 42 men, 26 women; mean age, 50.7 years; age range, 29-73 years) or RFA alone (n = 68; 47 men, 21 women; mean age, 48.9 years; age range, 30-74 years). Patients with viable tumors at computed tomography (CT) 4 weeks after treatment received additional treatment. Rates of local tumor progression and overall survival were evaluated by using Kaplan-Meier and log-rank tests, respectively. The relative prognostic significance of variables in predicting overall survival and the time to tumor recurrence or metastasis were assessed with multivariate Cox proportional hazards regression and logistic regression analyses, respectively.

Eligibility Criteria:
Inclusion Criteria:

(a) age 18-75 years and refusal to undergo surgery; (b) a solitary HCC 7.0 cm in diameter or smaller or multiple (up to three) HCCs 3.0 cm in diameter or smaller; (c) lesions visible at ultrasonography (US), with an acceptable and safe path between the lesion and the skin seen on the US scan; (d) no extrahepatic metastasis; (e) no imaging evidence of tumor invasion into the major portal or hepatic vein branches; (f) no history of encephalopathy, ascites refractory to diuretics, or variceal bleeding; (g) a platelet count of more than 40 000 cells/mm3 and (h) no previous treatment for HCC except liver resection.

Exclusion Criteria:

Exclusion criteria included active thyroid disease, serious concurrent medical illnesses, extrahepatic diseases, previous anticancer treatment before surgery, histologically proved non-HCC tumors and women who were pregnant or breastfeeding.
Evaluating the Effectiveness of Ondansetron Versus Dexamethasone Versus Placebo for the Control of Intraoperative Nausea and Vomiting in Patients Undergoing Lower-segment Caesarean Section Under Spinal Anesthesia

The goal of this randomized controlled trial is to evaluate the effectiveness of Ondansetron, Dexamethasone, and Placebo for intraoperative nausea and vomiting in patients undergoing caesarian section under spinal anesthesia. The main question it aims to answer are:

Which drug is the best at reducing the incidence of intraoperative nausea and vomiting.

Which drug is the best at reducing intraoperative pain.

Participants will be randomly divided into three groups, each will be given a different drug labelled A, B, or C.

A rating scale will be used to evaluate the severity of intraoperative nausea and pain. Episodes of vomiting will be recorded.

Data collected from the three groups will be analyzed using SPSS software.


Eligibility Criteria:
Inclusion Criteria:

* Age above 20 but less than 35 years old
* Given informed consent
* No contraindication to spinal anesthesia
* ASA I or II

Exclusion Criteria:

* Age less than 20 or more than 35 years old
* Non-consenting
* Contraindication to spinal anesthesia
* ASA III or IV
Oral Manifestations in Chronic Kidney Disease.

The goal of this observational study is to investigate oral manifestations in patients with Chronic Kidney Disease (CKD) for early detection, that alterations play an important point for dental guide during the progression and type of treatment of CKD .

An oral exam was performed for detection oral manifestations, age, smoking, alcoholic and oral hygiene habits were collected.

The study has 3 groups under study: hemodialysis (HD), peritoneal dialysis (PD) and pre-dialysis (P-D)


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years and ≤ 80 years;
* No change of medication in the last 3 months;
* History of CKD comported by data laboratory (GRF\<60 ml/min/1.73m²).

Exclusion Criteria:

* Age ≤ 18 years and ≥ 80 years;
* Patients undergoing orthodontic therapy;
* Patients taking drugs;
* Patients changes the medication or introduced a new medication.
VICO-trial: Video Consultations in the Follow-up of Children With Functional Abdominal Pain Disorders

The goal of this non-inferiority randomized controlled multi-center trial is to investigate the use of video consultations in the follow-up care of children aged 4 - 18 years old with functional abdominal pain disorders (FAPDs). Video consultations will be compared to face-to-face consultations. Clinical outcomes and patients' and parents' healthcare experience will be compared between both groups.

Primary outcome is adequate relief after 12 weeks: the hypothesis is that video consultations are not inferior to face-to-face consultations regarding clinical outcomes and that adequate relief will be the same for both groups.

Participants and/or parents will be asked to complete a diary for 1 week and a questionnaire after every consultation: at baseline, after 6 weeks and after 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 4 years to 17 years
* Meeting the Rome IV criteria for one of the four types of Functional Abdominal Pain Disorders (FAPD's): functional dyspepsia, irritable bowel syndrome, abdominal migraine, functional abdominal pain - not otherwise specified.
* Being able to conduct a video consultation

Exclusion Criteria:

* If no follow-up consultation is indicated
* If it is necessary that the follow-up consultations are face to face
Real-life Observational Study of Cancer Pain Management With Methadone

Study rational. Methadone is a distinctive opioid because of its pharmacological characteristics and its multiple modes of action, reinforcing its therapeutic value in managing advanced cancer pain, particularly in cases with a neuropathic component. However, the complex pharmacodynamics of methadone makes its prescription sometimes challenging. There is a wide inter-individual variability of its half-life. This long half-life is a valued characteristic for the management of patients treated for an addictive disorder. However, in the context of pain management, it greatly complicates the switch from and to another opioid, accentuating the risk of overdose. This is the reason why LBR, willing to improve his knowledge about Methadone in real life clinical practice wants to performe this study.

We anticipate that most patients will receive one of the above-described protocols, but we must anticipate that other protocols may be used in clinical practice in the absence of specific recommendations. Therefore it is of utmost relevance to describe the safety when initiating treatment with Zoryon® during the crucial period from D1 until the day of optimal dosage is determined (DOD) as the clinical practice may vary from a practician to another, and then until the routine follow-up visit one month after initiation of the treatment (D28).

To describe the occurrence of overdose and QTc prolongation in patients initiating a treatment with Zoryon® for intractable cancer pain not adequately relieved from other level 3 opioids, from the day of instauration (D1) to the day of determination of the optimal dose for the patient (DOD: Day of Optimal Dosage (DOD): the dosage of Zoryon® will be considered optimal after two consecutive days without modification to the posology (usually within the first week) AND pain relief for the patient.

Eligibility Criteria:
Inclusion Criteria:

* Patients with intractable cancer pain inadequately relieved by other opioids (ineffective and/or excessive adverse events) AND for whom switching from opioid to Zoryon® has been prescribed.
* be aged 15 years or older;
* suffer from cancer pain;
* be treated with a level 3 opioid with inadequate pain relief, i.e., ineffective, excessive adverse effects, or both;
* have a prescription to initiate Zoryon® treatment.

Exclusion Criteria:

* patients participating, or having participated within the previous month, in a clinical trial evaluating a new pain management treatment will be excluded, except for patients participating in the French experimentation of the use of therapeutical cannabis
IV Insulin Protocol in Diabetes and Renal Transplantation

Purpose: The purpose of this study is to provide tight blood sugar control using insulin given through the veins at the time of kidney transplantation and up to 3 days after surgery. After release from the hospital, the patient will control blood sugar with subcutaneous insulin injections or pills. With this approach, outcomes should improve for diabetic transplant patients such as longer life of the new kidney, fewer hospital readmissions, decreased associated infections, and other advantages.

Hypothesis: It is hypothesized that intensive glycemic control will lead to better clinical and biochemical outcomes and improved long-term graft survival.

Research Design: A randomized control trial comparing intensive intravenous insulin (IVI) for use in the hospital followed by intensive subcutaneous (sc) insulin use for in-patient and out-patient glycemic control will be conducted.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and greater,
* Diabetes diagnosis (Type 1 and Type 2, awaiting a living or cadaveric renal transplant, renal transplant candidates admitted to MUSC medical center for a donor kidney, FBG \>100 mg/dL per admission screening labs, random BG \>120mg/dL per admission screening labs, and
* Willing and able to provide informed consent

Exclusion Criteria:

* History of an active GI bleed in the previous 3 mos,
* Scheduled to receive a simultaneous pancreas transplant,
* History of a functioning pancreatic transplant,
* Patient currently managed on an insulin pump,
* Unable or unwilling to provide informed consent, and
* Unable to commit to the study protocol including the outpatient follow-up phase of care
The Different Response of Endocrine Hormones to Hypoglycemia in Patients With Type 1 or Type 2 Diabetes

Endocrine hormones, not only blood glucose responsive hormones, but also sexual hormones, thyroid hormones, growth hormones and so on, may have response and activites in hypoglycemia. However, the different responses of endocrine hormones to hypoglycemia in patients With diabetes remain unclear.

This study will observe the changes of insulin, C-peptide, glucagon, growth hormone, IGF-1, ACTH, cortisol, thyroid function, sexual hormone in newly diagnosed men with type 2 and type 1 diabetes mellitus using hyperinsulinaemic hypoglycaemic clamp technique

Eligibility Criteria:
Inclusion Criteria:

- Patients

* newly diagnosed male patients with type 1 or type 2 diabetes (diagnostic criteria of World Health Organization)
* aged 18-50 years
* has not been treated with any hypoglycemic drugs
* HbA1c\>9% Normal subjects: healthy and had no known illness

Exclusion Criteria:

* patients with insulin allergy.
* any history of hypoglycemic agent intake or were presently taking hypoglycemic agents
* any abnormality in liver or kidney function on blood and urine investigations
* any history of systemic corticosteroid use in 3 months
* any recent infections or acute medical events
* any other obvious conditions or associated diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors and other diseases, other pancreatic diseases, history of mental diseases.
Verification of Correct Positioning of a Gastric Tube by Ultrasonography

There are several ways to verify the correct positioning of a gastric tube. Radiography is considered the reference method. The use of ultrasonography could diminish the number of radiographies necessary. The hypothesis of this research is that gastric ultrasonography performed during insertion of the tube is a reliable examination to check the correct positioning of gastric tubes in intensive care.


Eligibility Criteria:
Inclusion Criteria:

* Patients, or their persons of trust, in cases of coma or sedated patients) who have given informed oral consent
* All patients hospitalized in the surgery intensive care unit of Dijon CHU, who are intubated and require a gastric tube

Exclusion Criteria:

* Adults under guardianship, patients under 18 years of age
* Patients without national health insurance cover
* Pregnant women
* Wound or dressing preventing gastric ultrasonography (laparotomy is not an exclusion criterion if the dressing does not prevent ultrasonography being performed)
* result of the radiographic verification seen before the gastric ultrasonography is done