cyrilzakka/clinical-trials huggingface dataset:
High Dose of Erythropoietin Analogue After Cardiac Arrest

The investigators hypothesised that the neuroprotective effects of erythropoietin and its analogues could lead to an improve outcome after cardiac arrest. To test this hypotheses, the investigators designed a randomized, multicentre, simple blind trial in which all participating patients will be receive usual treatments and 50% of them will also receive a high dose of epoetin alpha (an analogue of erythropoietin) in an "add on" fashion. The main end point will be the proportion of patients in each arm who will reach at day 60 the best level of recovery, using a 5 level score.

Rationale:

A recent pilot study showed encouraging results regarding the potentially beneficial effects of high dose epoetin alpha (an analogue of erythropoietin) when administered early after cardiac arrest. In this open label and non randomized trial, a high proportion of patients survived without significant cerebral disability and without experiencing severe adverse events (CARIOU et al. Resuscitation 2008). Efficiency of this treatment should now be evaluated in a randomized trial.

Hypotheses:

An early administration of a high dose of epoetin alpha (Epo) after cardiac arrest resuscitation could improve the neurological outcome of these patients by comparison with standard treatment. The proportion of patients reaching the level 1 of the Pittsburgh CPC scale (i.e., no or minor cerebral disability) at day 60 could attain 45% in the interventional group versus 30% as expected in the control group.

Design:

Multicentre, randomised, controlled, simple blind trial ("add on study").

Main goal:

To test the efficiency of a high dose of Epo administered at the early stage of the post-cardiac arrest period regarding its ability to improve the neurological outcome of these patients, when compared with standard care (including hypothermia when indicated).

Eligibility Criteria:
Inclusion criteria:

* Age between 18 and 80
* Witnessed out-of-hospital cardiac arrest, presumed of cardiac origin (non asphyxic)
* Time from cardiac arrest and recovery of circulatory activity less than 60 minutes
* Persistent coma after ROSC (Coma Glasgow Scale \< 7)

Exclusion criteria:

* Out-of-hospital cardiac arrest with evidence of extra-cardiac cause (trauma, sepsis, acute respiratory insufficiency, asphyxia)
* Previous or chronic treatment with erythropoietin or analogues
* Pregnancy
* Rapidly fatal underlying disease (expected life duration \< 6 months)
* No social security
Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-Cel) Out-of-Specification (OOS) in Participants With Multiple Myeloma

The purpose of this expanded access program (EAP) is to provide ciltacabtagene autoleucel (cilta-cel) that does not meet the commercial release specifications of CARVYKTI and is not available via the local health care system in the country where the treatment is requested.


Eligibility Criteria:
Inclusion Criteria:

* Eligible for treatment with cilta-cel per United States Prescribing Information (USPI)
* Has serious or life-threatening multiple myeloma per USPI, and where re-apheresis, re-manufacturing, or other anti-myeloma directed therapy is not considered feasible or adequate per treating physician discretion
* Favorable participant benefit/risk assessment determined by Janssen medical review
* Treating physician confirms the favorable risk benefit profile, and that proceeding with this treatment is in the best interest of the participant
* Able to provide informed consent indicating they understand the purpose of this expanded access program (EAP)
* A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) pregnancy test during screening and prior to the first dose of cyclophosphamide and fludarabine
A Pilot Study of Minocycline in Intracerebral Hemorrhage Patients

The MACH Trial is a pilot study of 400mg minocycline over five days in acute intracerebral hemorrhage patients. The study will evaluation the safety and efficacy of minocycline in intracerebral hemorrhage patients.

MACH is a randomized trial of minocycline in intracerebral hemorrhage. 24 total subjects will be randomly assigned to minocycline or control (1:1). The first dose will be given intravenously. Subsequent doses will be given orally every 24 hours for a total of five doses. The study will test to see if the medication is safe in intracerebral hemorrhage. The pharmacokinetics of minocycline in intracerebral hemorrhage will be determined and the impact of minocycline on blood biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* Intracerebral hemorrhage documented by CT scan
* The first dose of the drug can be administered within 12 hours of time last known to be at baseline

Exclusion Criteria:

* Allergy to tetracycline antibiotics
* Pregnancy or suspected pregnancy (pregnancy test will be done on women of child-bearing potential)
* Hepatic and/or renal insufficiency (LFT's \>3x upper limit of normal; Creatinine \>2mg/dL)
* History of intolerance to minocycline
* National Institutes of Health Stroke Scale score of 4 or less
* Glasgow Coma Scale score of 5 or less
* Surgical evacuation of hematoma planned within 24 hours
* Secondary intracerebral hemorrhage resulting from trauma, arteriovenous malformation, aneurysm, tumor or other causes
* Thrombocytopenia (platelet count \<75,000/mm3) or coagulopathy (INR \>1.4)
* Previously not independent (prestroke modified Rankin scale score \>2)
* Suspected of not being able to comply with the study protocol
* Unlikely to be available for 90 day follow-up
* Pre-existing Do Not Resuscitate (DNR) order or indication that a new DNR order will be implemented within the first 48 hours of hospitalization
Efficacy of a Brain-Computer Interface Controlled Functional Electrical Stimulation Therapy for Spinal Cord Injury Neurorehabilitation

The study's main goal is to determine the efficacy of a therapy with brain-computer interface controlled functional electrical stimulation for neurorehabilitation of spinal cord injury patients' upper limbs. For this purpose, a randomized controlled trial will be performed to compare the clinical and physiological effects of the brain-computer interface therapy with those of a sham intervention comprised by the application of functional electrical stimulation independently of brain-computer interface control.


Eligibility Criteria:
Inclusion Criteria:

* Spinal Cord Injury at neurological levels C6 or C7
* American Spinal Injury Association (ASIA) classification A, B, C or D
* Upper limb spasticity of less or equal to +1 measured with the Modified Ashworth Scale
* Time since disease onset of more than 6 months and less than 60 months
* Normal or corrected to normal vision

Exclusion Criteria:

* Severe attention deficits
* Previous diagnosis of traumatic brain injury
* Previous diagnosis of peripheral nerve injury
* Previous stroke diagnosis
* Previous diagnosis of neurodegenerative diseases
* History of fractures in upper extremities
* Skin lesions
* Contractures in upper extremities that hamper mobility
* Excessive muscle spasms
Renal Anemia Refractory to Erythropoietin

This study evaluates the renal anemia refractory to Epo . in hemodialysis patients. all of participants will receive Epo. and identify various factors contributing to etiology of renal anemia in Epo- resistant patients.

Chronic kidney disease (CKD) is considered a public health problem worldwide with high incidence and prevalence rates.Anemia is one of the most frequent early complication of CKD. The main cause is erythropoietin (EPO) deficiency due to impaired kidney function However, other causes should be considered when the severity of anemia is inconsistent with the decrease in renal function; when there is evidence of iron deficiency or matching decreases in hemoglobin, leukopenia and/or thrombocytopenia are also found

Eligibility Criteria:
Inclusion Criteria:

* Patients greater than or equal to 18 years old with CKD on hemodialysis

Exclusion Criteria:

1. - Evidence of infections especial of vascular access .
2. - malnutrition and manifestation of iron, B12, folate and protein deficiency .
3. - any underling cause as;

   * Hematologic malignances -Hemolytic anemia -
   * Aplastic anemia (infection and/or bleeding with anemia)
   * Solid tumors
   * Bleeding (skin ,mucosal ,orificial)
   * Evidence of mineral bone disease (CKD-MBD)
   * Others
Percutaneous Renal Tumor Cryoablation Followed by Biopsy

This study is being done to test how effective cryoablation is in killing cancer cells. Cryoablation uses freezing temperatures to treat cancer. Cryoablation works by creating freezing temperatures within a needle probe. When this probe is inserted into a cancer, the freezing temperatures are used to try and kill the cancer. Unfortunately, the investigators don't know how well cryoablation works at destroying the cancer. This study will allow us to check to see how well cryoablation works for kidney cancers. After the investigators destroy the kidney cancers using cryoablation, the investigators will followup with you every 5-7 months to make sure the cryoablation worked and that the cancer was destroyed.


Eligibility Criteria:
Inclusion Criteria:

* Presence of at least one renal cancer smaller than or equal to 3.0 cm
* Adequate baseline imaging studies (CT/MRI) within 8 weeks of treatment or as clinically indicated.
* The following laboratory results should be within the following limits within the last 30 days prior to study day 1. Repeat blood work will be necessary if too much time has elapsed prior to the interventions.:
* Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
* Platelet count ≥ 100 x 109/L
* Serum bilirubin ≤ 2.0 mg/dL
* Aspartate aminotransaminase (AST) ≤ 2.5 x ULN
* Alanine aminotransferase (ALT) ≤ 2.5 x ULN
* Serum creatinine ≤ 2.0 mg/dL
* GFR \>30 mL/min/m2
* International Normalized Ratio \< 1.5 (INR)
* Partial Thromboplastin Time (PTT) \<45 seconds
* Recovered from toxicity of any prior therapy
* Tumor accessible to probe placement without risk to adjacent critical structures.
* Tumor visible on non-contrast CT
* Patient willing and able to undergo imaging and percutaneous biopsy at 5-7 month intervals for 2 years and then at the discretion of the patient's physicians.

Exclusion Criteria:

* Intercurrent medical condition that renders the patient ineligible for cryoablation
* Women who are pregnant or breastfeeding.
* Tumor less than 5 mm to the renal pelvis, main renal vessel, ureter, or other vital structure
* Contraindication to MRI in patients in which it is required.
* Coagulopathy as defined above (Inclusion Criteria).
* Patients unwilling to return for follow-up biopsy and imaging.
Pirfenidone, an Antifibrotic and Antiinflammatory Drug

The aim of this study was to assess whether two-year treatment with Pirfenidone influence necro-inflammation, fibrosis and steatosis in patients with chronic hepatitis C.


Eligibility Criteria:
Inclusion Criteria:

* Patients with established advanced liver disease caused by hepatitis C virus (HCV) chronic infection defined by a positive test for anti-HCV antibodies and detectable serum HCV RNA (Amplicor HCV 2.0 polymerase chain reaction (PCR) assay).
* Sign an informed consent form to allow the collection of liver biopsies before and after treatment.
* No antifibrotic, antiviral or immunosuppressive drugs for at least 6 months before starting pirfenidone therapy.
* No alcohol intake for at least 6 months before nor during Pirfenidone (PFD) treatment.

Exclusion Criteria:

* Patients with clinical contraindications to hepatic biopsy
Low-Intensity Focused Ultrasound Pulsation (LIFUP) for the Treatment of Generalized Anxiety Disorder (GAD)

There are few treatment options available for patients once they have failed standard psychopharmacological therapy for generalized anxiety disorder. Existing brain stimulation methods such as rTMS fail to target deep brain structures associated with anxiety disorders; structures such as the amygdala. In this double-blind sham-controlled clinical trial, the investigators propose to establish baseline severity of anxiety in 48 patients, then deliver eight treatments over four sessions of focused ultrasound stimulation to the amygdala. Anxiety severity will be assessed using standard psychometric scales after each session, and at follow-ups.

Anxiety disorders have tremendous disease burden in the United States. Up to 1 in 3 Americans will be diagnosed with an anxiety disorder in their lifetimes. Anxiety treatment is typically consisting of psychotherapy (e.g. cognitive behavioral therapy) and medication management (e.g. benzodiazepines, selective serotonin reuptake inhibitors, etc). With major depressive disorder, rTMS is a suitable alternative treatment for refractory depression, rTMS is not approved for treatment of anxiety, nor can rTMS stimulate deep enough to reach those brain circuits involved in anxiety (e.g. the amygdala). Focused ultrasound is a new treatment modality being developed for several different neuropsychiatric conditions. In this study, the investigators propose to randomize 48 individuals to either active or sham treatment. Each participant will be evaluated to establish a baseline diagnose of generalized anxiety disorder, and then will be reassessed after each treatment session (of which there are four). One week and one month after the last treatment session, the investigators will conduct follow-up evaluations.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female
2. Age 18-65
3. Normal or corrected-to normal vision and hearing
4. Primary diagnosis of generalized anxiety disorder, moderate/severe per DSM-5. (HAM-A\>17) 4a) The duration of the illness must exceed one year.
5. Must be medically stable as determined by investigator
6. Patient must have attempted and failed treatment with at least 2 SSRI and 1 augmentation
7. History of rTMS is permitted, but not required.

Exclusion Criteria:

1. Diagnosis of primary DSM-5 anxiety disorder other than GAD 1a) Affective disorders such as unipolar or bipolar depression are permitted as long as GAD is primary
2. Current use of any non-prescribed psychoactive medications or drugs (aside from medications for treatment of GAD)
3. Contraindication to enter the MRI environment
4. Pregnancy (or suspected/possible pregnancy or plan to become pregnant in the short-term)
5. Inability to adhere to treatment schedule
6. Initiation of new anxiolytic treatment at the time of study randomization
Fluid Administration in Ketoacidosis (DRINK)

Management of severe diabetic ketoacidosis is based on insulin therapy, correction of metabolic disorders and fluid resuscitation. Current recommendations recommend the first-line use of isotonic saline, whose composition is unbalanced, rich in chloride and sodium compared with plasma. Administration of large volumes of isotonic saline is associated with a risk of hyperchloremic metabolic acidosis and acute renal failure. Balanced solutions (e.g. Ringer Lactate) are solutions with a more balanced electrolyte composition close to that of plasma. They could therefore enable diabetic ketoacidosis to be resolved more quickly than isotonic saline, due to a lower risk of hyperchloremic acidosis. Preliminary data suggest a potential benefit of balanced solutions for fluid resuscitation of patients with severe diabetic ketoacidosis in terms of resolution of diabetic ketoacidosis, but no randomized controlled double-blind study to date has compared balanced solution vs. isotonic saline in this context.


Eligibility Criteria:
Inclusion Criteria:

* Admission to emergency department or direct admission to ICU
* Diagnosis of severe diabetic ketoacidosis requiring all the following criteria:
* Blood or capillary glucose \> 11 mmol/L
* Ketonemia or ketonuria \> 0
* Venous or arterial pH \< 7.30 or venous or arterial bicarbonate \< 15 mmol/L
* Volume of fluid administered before inclusion \<1L

Exclusion Criteria:

* Patients \<18 years
* Pregnant women
* Patients under protection
* Patients with a decision to withdraw life-sustaining therapy
* Contraindication to isotonic saline or Ringer Lactate
* Non-affiliation to social security
Determination of Metal Ion Serum Levels and Cytokines in Total Hip Replacement

The goal of the study is the analysis of metal ion serum concentrations and of the cytokine production in the blood of patients with a conventional cementless total hip replacement. The rationale is that a) the bearing wear releases particles respectively metal ions into the joint and the blood which will differ in quantity and composition; b) the cytokine production of peripheral blood mononuclear cells (PBMC) might be influenced to a varying degree by the metal and the ceramic particles.

The patients from whom the respective samples will be analyzed are randomized in one of the following three groups: metal-on-metal, ceramic-on-ceramic or ceramic-on-metal. A 36mm bearing is used in all patients. In this separate study, follow-up data of the clinical and radiographic examinations of the patients are available.


Eligibility Criteria:
Inclusion Criteria:

* age over 18 years, necessity of hip replacement, informed consent

Exclusion Criteria:

* acute inflammatory disease, renal disease, other cobalt-chromium implant, ager over 75 years
HPA Axis Study in Japanese Adults

A multicenter, open-label study to evaluate the adrenal suppression potential of Mapracorat 0.1% ointment in Japanese adults with atopic dermatitis.

Assessment of the adrenal suppression potential, safety, efficacy and pharmacokinetics of Mapracorat 0.1% ointment in Japanese adults with atopic dermatitis.

Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Male or female subject aged \>= 20 years
* Diagnosis of atopic dermatitis according to the Hanifin and Rajka criteria
* Investigator's Global Assessment (IGA) score of 3 (moderate) to 4 (severe) at baseline
* Normal ACTH response before start of treatment

Exclusion Criteria:

* Pregnancy or lactation
* Clinically relevant disease, which could interfere with the study conduct or the evaluation and interpretation of the study results
* Concomitant medical or dermatological disorder(s), which could interfere with the investigator's ability to evaluate the subject's response to the investigational product
* Clinically manifest immunosuppressive disorder or known history of malignant disease
Clinical Study on the Efficacy and Safety of RC48-ADC in the Treatment of Metastatic Castration Resistant Prostate Cancer (mCRPC)

This is a single-arm, open, single-center clinical study to evaluate the efficacy and safety of RC48-ADC in patients with mCRPC who have progressed after NHT. A total of 40 patients with mCRPC with immunohistochemically confirmed HER2 expression who had progressed after treatment with at least one novel endocrine therapy will be included in this study.

This is a single-arm, open, single-center clinical study to evaluate the efficacy and safety of RC48-ADC in patients with mCRPC who have progressed after NHT. A total of 40 patients with mCRPC with immunohistochemically confirmed HER2 expression who had progressed after treatment with at least one novel endocrine therapy will be included in this study. Participants will receive RC48-ADC intravenous injection (2.0 mg/kg, Q2W) until disease progression or death. During the treatment, participants will evaluate every 4 weeks, including PSA testing every 4 weeks and tumor evaluation according to PCWG3 standards every 8 weeks. If the patient develops disease progression, the treatment will be discontinued and survival follow-up will be conducted every 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* 1) Prostate cancer confirmed by histology;
* 2) ≥ 18 years old;
* 3) The presence of metastatic lesions confirmed by bone scan and/or CT/MRI and/or PET-CT;
* 4) ECOG score 0-2;
* 5) Continuously maintain ADT treatment and maintain testosterone levels ≤ 50ng/dL; The progression of prostate cancer recorded within 6 months prior to screening;
* 6) Having received at least one NHT in the past before progressing;
* 7) HER2 IHC 1+, 2+, or 3+;
* 8) Inability to or refusal docetaxel chemotherapy;
* 9) Voluntarily join the study;
* 10) Expected survival time ≥ 6 months;
* 11) Normal function of main organs;

Exclusion Criteria:

* 1)Have a history of malignant tumors other than prostate cancer;
* 2)Previously received allogeneic stem cell or parenchymal organ transplantation;
* 3) Previously or currently suffering from congenital or acquired immunodeficiency diseases;
* 4) The patient have a history of allergy to RC48 or paclitaxel, or a history of Hypersensitivity to chimeric or humanized antibodies or fusion proteins, or allergy to excipients of the study drug;
* 5) Other significant clinical and laboratory abnormalities that affect safety evaluation;
* 6) Those who are unwilling or unable to take effective contraceptive measures;
* 7) Subjects with active brain metastasis;
Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction

This study tested the hypothesis that vardenafil was both clinically effective and well-tolerated compared to placebo in men diagnosed as being unresponsive to sildenafil.


Eligibility Criteria:
Inclusion Criteria:

* Men \>/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement,
* History of unresponsiveness to sildenafil
* Stable sexual relationship for \> 6 month

Exclusion Criteria:

* Primary hypoactive sexual desire
* History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
* Nitrate therapy
A Safety and Immunogenicity Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31)

The study has the following objectives:

Primary objective To evaluate the safety profile of an adjuvanted TB subunit vaccine administered in different antigen/adjuvant formulations at 0 and 2 months Secondary objective To determine the immunogenicity profile of an adjuvanted TB subunit vaccine administered in different antigen/adjuvant formulations at 0 and 2 months.

Number of trial subjects=48 Investigational product=Ag85B - ESAT-6 + IC31 Dosage Group 1: TST negative, 50 µg antigen Group 2: TST negative, 50 µg antigen + fixed adjuvant Group 3: BCG vaccinated, 50 µg antigen + fixed adjuvant Group 4 : Latent TB, 50 µg antigen + fixed adjuvant Dosage volume 0.5 ml Administration Intramuscularly into deltoid muscle, alternate arms at day 0 (right) and day 56 (left).

Eligibility Criteria:
Inclusion Criteria:

* Male between 18 and 40 years old
* TST negative groups: TST- and negative QuantiFERON-TB Gold In tube test
* BCG group: known to be BCG-vaccinated \> 2 years before(scar, vaccination card), TST+ (\> 6 or any documented value \> 6 mm on medical file in the past), with no active, chronic or past TB disease as confirmed by chest X ray, negative QuantiFERON-TB Gold In Tube test and negative 6-day lymphocyte tests.
* Infection group: latent TB, TST+ ( = or \> 10 mm or documented = or \> 10 mm positive on medical file in the past), previously TB infected but with no active disease confirmed by chest X ray, may have received chemoprophylaxis but with no TB treatment/chemoprophylaxis within the preceding 2 years, positive QuantiFERON-TB Gold In Tube test and/or positive 6-day lymphocyte test.
* Healthy based on medical examination/history at the inclusion
* Signed informed consent
* Prepared to grant authorized persons access to the medical records
* The volunteer is likely to comply with instructions

Exclusion Criteria:

* Confirmed active TB based on clinical evaluation(history, physical findings and investigations)
* Vaccinated with any vaccine 3 months before first vaccination
* Administration of immune modulating drugs (steroids, immunosuppressive drugs or immunoglobulins)
* HBV, HCV or HIV sero-positive
* Participation in other clinical trials
* Known hypersensitivity to any of the vaccine components
* Laboratory parameters outside of normal range considered clinically relevant