cyrilzakka/clinical-trials huggingface dataset:
Does Omega-3 Fatty Acid Supplementation in Pregnancy and During Lactation Protect the Child From Allergic Disease?

The incidence of allergic diseases has increased and a relation between allergy and dietary fatty acids has been proposed. Modulation of the maternal immune function during pregnancy may have an impact on future clinical outcomes in the child. The aim of this study was to determine the effects of omega (ω) - 3 long-chain polyunsaturated fatty acid (LCPUFA) supplementation during pregnancy and lactation on the development of allergic disease (i.e., allergic eczema) in the child at 2 years of age. Pregnant women with allergic disease in their immediate family were supplemented daily with 2.7 g ω-3 LCPUFA (n=70) or 2.8 g soybean-oil as placebo (n=75) from gestational week (gw) 25 until the third month of breastfeeding. Skin prick tests, detection of circulating specific IgE antibodies and clinical examinations of the infants were performed at 3, 6, 12 and 24 months of age. The mothers and children were monitored regarding immune modulatory effects during the entire study period.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman, at 25 weeks of gestation, with allergic symptoms (rhinitis, conjunctivitis, eczema, asthma or food allergy) herself or the father to be or an older sibling

Exclusion Criteria:

* Soy allergy
* Fish allergy
* Treatment with anti-coagulation
* Commercial omega-3 supplementation
Efficacy and Safety Study of Total Glucosides of Paeony Combined With Acitretin to Treat Psoriasis

This is a randomized, double blind, placebo parallel-controlled, multi-center clinical trial. Patients with psoriasis vulgaris were randomly divided into the experiment group （treated with TGP combined with acitretin capsules) and control group （treated with placebo combined with acitretin capsules）.The treatment lasted 12 weeks. The efficacy and safety were evaluated at the baseline, as well as 2, 4, 8 and 12 weeks after the beginning of treatment.The investigator's hypothesis TGP combined with Acitretin Capsulesin is more safe and effective than Acitretin Capsulesin to treat Psoriasis Vulgaris.


Eligibility Criteria:
Inclusion Criteria:Meet the following conditions

1. Diagnosed according to Classification criteria for Psoriasis vulgaris;
2. Patients aged 18 to 65 years (to the date of screening);
3. PASI grade\>7point\<20 point;
4. Not treatment in the Topical corticosteroids、Immunosuppresso、Biologicals agents or Tretinoin cream、Phototherapy nearly one months before enrolled.
5. Understanding the whole process of the study, voluntary participation and signed the informed consent;
6. Patient compliance is good, can guarantee in course of observation.

Exclusion Criteria:One of the following is not included in this study:

1. Pregnant women, ready to pregnant or lactating women;
2. Known to root of herbaceous peony total glycosides (TGP) drug allergy;
3. Have a serious heart, lung, kidney and other vital organs and endocrine system lesions and the history
4. Patients is liver function abnormal persons (ALT above the center laboratory normal limit) or hepatitis b patient grain carriers;
5. Need insulin control of diabetes; High blood pressure did not get good controller ;
6. Patients with white blood cells \<4.0 × 109 / L, or a definite anemia (hemoglobin less than 100g / L), or platelets \<100 × 109 / L, or other blood disease;
7. Patients with chronic diarrhea, or peptic ulcer nearly 1 year;
8. Patients suffering from malignant tumor;
9. Patients suffering from acute and chronic infectious diseases;
10. Mental disorders, history of alcohol abuse, drug or other substance abuse; 11. Other cases which researchers believe that can not enroll.
Transcriptome Assessment After Cardiac Arrest

The purpose of this study is to determine whether the blood transcriptome of patients resuscitated after out-of-hospital could be an early predictor of the neurological outcome.

Assessing the prognosis of the patients resuscitated after out-of-hospital cardiac arrest (OHCA) is still highly challenging. Beyond usual neurological markers, experimental and clinical studies have also shown that blood levels of several cytokines or miRNA could be significantly different after cardiac arrest in subjects prematurely died as compared to survivors with a good neurological recovery. Here the investigators propose to investigate a screening approach assessing simultaneously multiple targets of the post-cardiac arrest syndrome through analysis of the whole transcriptome of patients after OHCA. For this purpose, the investigators will collect blood samples from 60 patients after admission at hospital and then 1 and 3 days later. The Pittsburgh Cerebral Performance Category of each patient will be evaluated for each patient at day 60 after cardiac arrest. At the end of the collection period, the blood samples will be prepared for whole genome analysis and RNA sequencing. The primary analysis of the investigators will be the comparison of the transcriptome at day 0 after cardiac arrest in patients reaching Cerebral Performance Category (CPC) 1 at day 60 as compared to all other patients.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 80 years
* Delay between patients collapse and resumption of spontaneous circulation (ROSC) \< 60 minutes
* Comatose patients ROSC with Glasgow score \< 7
* Patient already registered in the social security system
* Consent of a family member, if able to understand in the emergency context, or attestation of emergency situation with a follow-up information notice

Exclusion Criteria:

* Cardiac arrest supposed to be provoked by trauma or sepsis
Pilot Study of Intervention to Reduce Sunburns in Melanoma Survivors

This project will pilot test whether a wearable device that tracks sun exposure and provides alerts regarding sun exposure and protection behaviors will reduce sunburns in melanoma survivors. The use of wearable technology devices has grown quickly over the last decade and studies using these devices to promote physical activity and weight loss have been promising. The investigators will pilot test the technology device versus a similar control device in 80 melanoma survivors and compare sunburns between the two groups after the three month intervention.


Eligibility Criteria:
Inclusion Criteria:

* 18-75 years old
* Diagnosed with stage I-III cutaneous invasive melanoma between 2009 and 2017 and treated at the University of Minnesota
* Able to read/write in English
* Own a smartphone
* Able to provide voluntary informed consent

Exclusion Criteria:

-Patients currently undergoing adjuvant therapy.
Post-thrombotic Syndrome After Deep Venous Thrombosis (DVT) in Patients Treated According to the NOPHO ALL2008 Protocol

Acute lymphoblastic leukemia (ALL) is the most common malignant disease in childhood. Today more than 90% of children and 75% of adults (18-45 years) survive ALL. The enzyme Asparaginase (Asp) is an indispensable part of the multiagent treatment of ALL.

Treatment related severe acute toxicities are common. Especially in teenagers and adults, thromboembolism is one of the most common acute toxicities and may result in post thrombotic syndrome (PTS) or pulmonary hypertension. The knowledge about these late effects is limited, including for ALL patients.


Eligibility Criteria:
Inclusion Criteria:

* Treated on the ALL2008 protocol for ALL. Had a DVT on treatment.

Exclusion Criteria:

* Death
Comparison of the Efficacy of Inflexal V With a Commercially Available Influenza Vaccine in Young Children

A study to assess whether the Northern Hemisphere 2009/2010 season influenza vaccine Inflexal V is as immunogenic as a locally sourced competitor vaccine in young children.


Eligibility Criteria:
Inclusion Criteria:

* ≥6months to ≤35 months-old healthy children (male or female) born at term after normal pregnancy
* Recording of medical history and physical examination reveal no abnormality
* The parent/legal guardian of the participating child must sign the written informed consent and agree to provide a blood sample taken from the child pre- and post-immunization

Exclusion criteria:

* Hypersensitivity to eggs, chicken proteins, polymyxin B, neomycin or any component of the vaccine
* Previous vaccination against influenza
* At time of enrollment, presentation of clinical symptoms of active infection and/or body temperature ≥38°C
* Confirmation or suspicion of immunosuppressed status (including cancer), or confirmation of immunodeficiency disease (congenital or acquired including HIV)
* Medical treatment (\>2 weeks) with immune suppressant or immune modulating drugs including systemic steroids during the last 3 months before immunization or at present, as follows: long-term oral prednisone or other equivalent steroid: ≥0.5mg/kg/day (note: administration of local or inhaled steroids before or during the study is allowed)
* Treatment with immunoglobulins or blood products during the last 3 months before immunization or such treatment scheduled during the study
* Participation in other clinical trials during the last 3 months before immunization or intention to participate during this study period
* At present or during the last 6 months before immunization: radiotherapy or treatment with cytotoxic drugs
* Other vaccination with a killed vaccine within 14 days before immunization or with an attenuated vaccine within 28 days before immunization (note: after subject inclusion vaccines of the immunization program for children are allowed upon the physician's discretion. However, immunization on the same day must be avoided)
* Family history of Guillain-Barré Syndrome
* Severe congenital deficiency or disease
* Antecedent of neurological disease or epileptic attack
* Severe cardiopulmonary disease with possibility to influence the study result
* Disturbance of coagulation or under anticoagulant treatment, likely to be contraindicated to i.m. injection
* Suspected non-compliance
Labial Frenulum Surgery - a Comparative Study of Conventional Scalpel and Er-Yag Laser Technique

The aim of the study was to compare the outcome in terms of wound healing time, surgery time, bleeding and patient experience of the ectomy of frenulum when performed with laser technology versus conventional scalpel technique. A prospective, single-blind, randomized and controlled study was performed. Wound healing was assessed five and ten days after after surgery. The long-term outcome were assessed blinded by a dentist not earlier involved in the study.

Children referred to a pediatric clinic to surgically remove a labial frenulum were randomized to treatment with conventional scalpel or laser treatment technology after parents and children had given consent to participate. During the surgery the time required for the procedure and the amount of bleeding the different techniques caused were measured. Wound healing was assessed five and ten days after surgery by a clinical judgement and by analysing photos. Three months after surgery an independent dentist assessed the long-term outcome by a clinical examination. The patients´ view of the treatment were assessed directly after the surgery and five days, ten days and three months after the surgery.

Eligibility Criteria:
Inclusion Criteria:

* patients in need of frenulum labials surgery

Exclusion Criteria:

* patients with severe general diseases (ASA\>2)
* patients who required general anaesthesia for treatment
Incidence and Clinical Burden of Erythropoietin Hyporesponsiveness - a Retrospective Database Analysis

This study consists of two phases. The purpose of phase 1 is to identify incidence and patterns of erythropoiesis-stimulating agent (ESA) hyporesponsiveness and its associated factors in ESA treated patients. The purpose of phase 2 to identify outcomes associated with ESA hyporesponsiveness. Key aspects of the phase 2 study design will entirely depend on the results from phase 1.

This is a retrospective database analysis of patients with anemia associated with chronic kidney disease (CKD) treated with ESAs from January 1st 2015 - December 31st 2021. Data will be derived from European Clinical Database (EuCliD).

Eligibility Criteria:
Inclusion Criteria:

All patients

* Patient has a diagnosis of chronic kidney disease valid between January 1st, 2015, and December 31st, 2021 and is documented in the EuCliD database (incident and prevalent patients)
* Patient who is treated with renal replacement therapy (RRT) (CKD Stage 5) during the study period
* Patient receiving erythropoiesis-stimulating agent (ESA) therapy, within the data collection period having EuCliD data available for a period of the previous 30 days before Index Date but not strictly limited to patients that enter the study period as ESA naïve patients
* Patient having provided consent for secondary use of their data for research purposes
* Patient has a known ESA administration route (intravenous/subcutaneous)
* Patient with a hemoglobin value available at baseline (+/- 20 days allowed) and at least one valid hemoglobin value afterwards
* Patient having at least one body weight value available

Hyporesponsive Cohort

* Patients meeting the hyporesponsive criteria on at least one occasion. The criteria for ESA hyporesponsive will follow the National Institute for Health and Care Excellence, UK (NICE) guidelines:

  * for epoetin alfa, 300 IU/kg/week or more of subcutaneous epoetin or 450 IU/kg/week or more of intravenous epoetin
  * for darbepoetin, dose ≥ 1.5 μg/kg per week

Responsive Cohort

* Patients with all ESA doses lower than those defined by the hyporesponsive criteria

Exclusion Criteria:

* Patient with evidence of hereditary hemolytic anemia (International Classification of Diseases 10th Revision \[ICD-10\] code D58.9)
* Patient receiving transplant within 6 months prior to Index Date
Phase I Study of JWCAR029 in Subjects With R/R CLL/SLL

This is a Phase I, open-label, single-arm, single center study to assess the safety and efficacy of JWCAR029 in subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Upon the successful product generation of Relmacabtagene Autoleucel, subjects will enter the treatment phase of the study. Treatment will include lymphodepleting chemotherapy followed by Relmacabtagene Autoleucel administration. Subjects will then enter the post-treatment follow-up phase of the study and will be followed for approximately 24 months for safety, disease status, and survival. Long-term follow-up will continue under a separate long-term follow-up protocol, currently up to 15 years after the last Relmacabtagene Autoleucel administration.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old and ≤ 75 years old;
* Sign on the informed consent;
* Diagnosis of:

  1. CLL with an indication for treatment based on iwCLL 2018 and measurable disease, or
  2. SLL (lymphadenopathy and/or splenomegaly and \< 5×10\^9 CD19+ CD5+ clonal B lymphocytes/L \[\< 5000/µL\] in the peripheral blood at diagnosis with measurable disease that is biopsy-proven SLL);
* Relapsed/refractory patients, Subjects must have received and failed Bruton tyrosine kinase inhibitor (BTKi) treatment or have been deemed ineligible for BTKi therapy;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
* Expected survival is greater than 12 weeks;
* Adequate organ function;
* Adequate vascular access for leukapheresis procedure;
* Women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of JWCAR029; Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 1 year after the last dose of JWCAR029.

Exclusion Criteria:

* Central nervous system (CNS) only involvement by malignancy or primary CNS lymphoma;
* History of another primary malignancy that has not been in remission for at least 2 years;
* Subjects has HBV, HCV, HIV or syphilis infection at the time of screening;
* Deep venous thrombosis (DVT)/Pulmonary embolism (PE), or DVT/PE requires anti-coagulation within 3 months prior to signing the ICF;
* Subjects with uncontrolled systemic fungal, bacterial, viral or other infection;
* Presence of acute or chronic graft-versus-host disease (GVHD);
* History of any serious cardiovascular disease or presence of clinically relevant CNS pathology;
* Pregnant or nursing women;
* Subjects using of any chemotherapy, corticosteriod, experiment agents, GVHD therapies, radiation or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis;
* Received allo-hematopoietic stem cell transplantation therapy previously.
* Uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol;
* Received CAR T-cell or other genetically-modified T-cell therapy previously.
The Metabolic Road to Diastolic Heart Failure: Diastolic Heart Failure Study

The main objective is to replicate the validation of omics biomarkers of left ventricular diastolic dysfunction in patients with metabolic syndrome.

The aim was to recruit overall 750 patients in Europe (100 for France). Currently, 625 patients were enrolled in Europe and 47 in France.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older
* Signs or symptoms of HF
* Able and willing to provide freely given written informed consent including analysis of genomics

Exclusion Criteria:

* Patients with acute myocardial infarction
* Recent trauma or surgery (\< 3 months)
* Hemodynamically significant valvular disease
* Serious cerebrovascular disease or stroke in the last 3 months
* Chronic dialysis
* Chronic liver disease
* Chronic infectious (bacterial or viral) disease
* Any malignant concomitant diseases or a malignant disease in the last 5 years
* Systemic inflammatory diseases, such as autoimmune diseases, connective tissue diseases or collagenoses
* Pregnant women
A Study To Evaluate The Effect Of Topiramate On Clinical And Electrophysiological Parameters In Subjects With Diabetic Peripheral Polyneuropathy

The purpose of the study is to evaluate the effect of topiramate on clinical and electrophysiological parameters in patients with diabetic peripheral polyneuropathy. The study will also evaluate the safety of topiramate in this patient population.

This is a multicenter, double-blind, placebo-controlled study to evaluate the effect of topiramate on clinical and electrophysiological parameters in patients with diabetic peripheral polyneuropathy. Patients will undergo the Baseline Phase when they are tapered off other pain medications, have diabetes controlled and eligibility reassessed. Patients will then be randomized to receive either topiramate or placebo and enter the Double-Blind Phase, which consists of Titration Period (topiramate dose will be titrated from 25mg/day to 200mg/day over 42 days) and Maintenance Period (study medication will be continued for 12 weeks). After the Double-Blind Phase, study medication will be tapered off during the Taper Phase, whose duration will vary depending on each patient. The evaluations include electrophysiological assessment, quantitative sensory assessment, and clinical assessment such as subjective pain scales. Safety evaluations (vital signs, clinical laboratory evaluations, physical and neurological examination, and evaluations of adverse events) will be conducted during the trial. During the first 42 days, doses of topiramate gradually increase to achieve the target dose (200mg daily by mouth), and then the dose is maintained for 12 weeks, after which the dose is slowly reduced and stopped over 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2 diabetes mellitus
* Pain for at least 6 months prior to randomization that the investigator attributes to diabetic peripheral polyneuropathy
* Two sets of baseline nerve conduction studies and Quantitative Sensory Testing
* HbA1c =\< 9%
* Diabetes controlled on stable regimen
* Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test)

Exclusion Criteria:

* Diagnosis of Type 1 diabetes mellitus
* Polyneuropathy due to other underlying causes
* Hospitalization within the past 3 months due to episodes of hyper/hypoglycemia
* Other unstable medical conditions
* History of suicidal attempts
* Exposure to any other experimental drugs or device within the past 30 days
Adherence in Patients Receiving PegIntron and Rebetol for Hepatitis C in Conjunction With a Patient Assistance Program (Study P04206)

Patients receiving a patient assistance program during therapy for Hepatitis C will be enrolled into this study. All patients will receive PegIntron and Rebetol (according to the label) and the patient assistance program, which includes (1) medications used for treatment (psychiatric medications); (2) other interventions (nurse support); and (3) educational literature. This study will be compared to similar studies from other clinics using various patient support programs for the purpose of designing future comparative phase IV studies.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic hepatitis C naive to treatment

Exclusion Criteria:

* None
Optic Nerve Sheath Diameter in Urologic Surgery

The investigators aimed to determine intracranial pressure changes during spinal and general anesthesia by using optic nerve sheath diameter and near infrared spectrometer in urologic surgery patients in lithotomy position. Also the investigators plan to evaluate to measure intrathoracic pressure effects to intracranial pressure.

The patients will be divided into 2 groups as those who underwent general anesthesia and spinal anesthesia.Both groups at the specified times.

(The patient is supine for both groups before the start of the anesthesia procedure.) position T0, for group G, T1G 2 minutes after intubation, T1S 2 minutes after spinal anesthesia for group S, two T2, lithotomy 5 minutes after the lithotomy position for the group lithotomy to T3 30 minutes after the T4, T5 in PACU ) 60 minutes after optic nerve sheath diameter (OSC) values and lung assessment (LUS), cerebral cerebral palsy with Near-infrared spectroscopy (NIRS) oxygenation, mean arterial pressure, peripheral oxygen saturation, serum sodium, arterial carbon dioxide values and heart rate values will be recorded and significant statistical differences will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1-2-3, patients
* over 18 years of age who will undergo urological surgery

Exclusion Criteria:

* Existing disease that causes an increase in intracranial pressure
* Patients with optic nerve pathology,
* Ophthalmologic diseases
THOR Study: A Study of Continued Herceptin (Trastuzumab) in Combination With Second Line Chemotherapy in Patients With HER2 Positive Metastatic Breast Cancer.

This 2 arm study will compare the efficacy and safety of continuation or discontinuation of Herceptin treatment in combination with 2nd line chemotherapy, in patients with HER2 positive metastatic breast cancer whose condition has progressed on 1st line chemotherapy plus Herceptin. Patients will be randomized either to continue or discontinue Herceptin treatment (2mg/kg iv infusion weekly, or 6mg/kg iv infusion every 3 weeks) while receiving 2nd line chemotherapy of the investigator's choice. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* female patients, \>=18 years of age;
* metastatic breast cancer;
* HER2 overexpression (IHC 3+ and/or FISH positive);
* disease progression during or after previous 1st line chemotherapy plus Herceptin;
* scheduled to receive 2nd line chemotherapy.

Exclusion Criteria:

* incompatibility with previous Herceptin therapy;
* pregnancy.