cyrilzakka/clinical-trials huggingface dataset:
Immunogenicity and Safety of Rabies Vaccine, Administered With Two Different Simulated Post Exposure Schedules

This study was planned to establish the non-inferiority of Rabipur administered as simulated post exposure Zagreb schedule as compared to Essen schedule, in healthy Indian adult subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females of age ≥ 18 years.
2. Individuals who had given written consent.
3. Individuals in good health and available for all the visits scheduled in the study.

Exclusion Criteria:

1. Pregnancy or unwillingness to practice acceptable contraception.
2. A history of Rabies vaccination.
3. History of allergy to egg protein.
4. Known hypersensitivity to neomycin, tetracycline, amphotericin-B or any other vaccine component.
5. A significant acute or chronic infectious disease or use of antibiotics that may impact the subject's safety and /or immunogenicity in the Investigators opinion at the time of enrolment.
6. Body temperature ≥38.0°C (≥ 100.4°F) within 3 days of study vaccination.
7. Treatment with an anti-malarial drug, up to two months prior to the study.
8. Individuals who received any other vaccines within 28 days prior to enrollment.
9. Subjects who have received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks.
10. Any planned surgery during the study period.
11. Subjects who have cancer disorders excluding nonmelanotic skin cancer.
Treatment in Patients Hospitalized With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Chronic obstructive pulmonary disease has become a serious global health care and public health problems due to its high prevalence, high morbidity and heavy economic burden. Acute exacerbation of chronic obstructive pulmonary disease is one of the most important causes of death in patients with COPD. Systemic corticosteroids therapy is recommended in COPD exacerbations. In clinical practice for the treatment of acute exacerbation of COPD， antibiotic application is still controversial. Evidence from current guideline is based on strict criteria from randomized controlled trials, thus the given condition is simplified. Patients meet the criteria account for the minority in the real world. Therefore, it is still not clear whether most patients benefit from the recommended treatment. In our design, hospitalized patients with acute exacerbation of COPD will be enrolled, with their treatment, arterial hypoxemia, recovery time and length of hospitalization being observed. The main purpose is to evaluate the benefit effect of current recommended treatment of acute exacerbation of COPD in the real world.

Chronic obstructive pulmonary disease has become a serious global health care and public health problems due to its high prevalence, high morbidity and heavy economic burden. Acute exacerbation of COPD is one of the most important causes of death in patients with COPD. The global strategy for the diagnosis, management, and prevention of COPD recommends systemic corticosteroids therapy in COPD exacerbations as it can shorten recovery time, reduce treatment failure, improve lung function and arterial hypoxemia. In clinical practice for the treatment of acute exacerbation of COPD， antibiotic application is still controversial. Evidence from current guideline is based on strict criteria from randomized controlled trials, thus the given condition is simplified. Patients meet the criteria account for the minority in the real world. Therefore, it is still not clear whether most patients benefit from the recommended treatment. In our design, hospitalized patients with acute exacerbation of COPD will be enrolled, with their treatment, arterial hypoxemia, recovery time and length of hospitalization being observed. The main purpose is to evaluate the benefit effect of current recommended treatment of acute exacerbation of COPD in the real world.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients with acute exacerbation of chronic obstructive pulmonary disease
* Age≥ 40years old

Exclusion Criteria:

* The first diagnosis which caused hospitalization is not acute exacerbation of chronic obstructive pulmonary disease
* Chest radiography shows congestive heart failure
* Chest CT shows lung cancer, active pulmonary tuberculosis, pulmonary thromboembolism or interstitial lung diseases
* Serious cardiac failure, renal insufficiency or hepatic dysfunction
Bemiparin Randomized Trial on Bridging Oral Anticoagulants in Invasive Procedures (BERTA Study)

Often it is necessary to temporarily discontinue OAT when surgical or other invasive procedures are required. However, there is no consensus on the optimal management in these situations, and heparin bridging therapy is the current usual practice in these situations. No large randomized, controlled clinical trials have been yet performed to evaluate the efficacy and safety of a low molecular weight heparins (LMWH) as bridging therapy.

THE MAIN OBJECTIVE of this study is to evaluate the efficacy and safety of the subcutaneous administration of Bemiparin 3,500 IU, for the peri-operative procedural management of patients requiring temporary interruption of oral anticoagulation therapy (OAT).

PRIMARY EFFICACY ENDPOINT: combined incidence of arterial and venous thromboembolic events and deaths from any causes within 3 months after the invasive procedure.

PRIMARY SAFETY ENDPOINT: incidence of major bleeding within 10 days after the invasive procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Patients over 18 years who have given their informed consent to participate in the study.
2. Patients receiving oral anticogulants during at least 3 months and who require outpatient surgery, laparoscopy surgery or invasive procedures
3. Procedures must be performed from 8 am to 15 pm.

Exclusion Criteria:

1. Patients with severe renal failure (creatinine clearance \<30 ml/min) or hepatic insufficiency (AST and/or ALT\>5 times the normal value established by the reference range of the local hospital laboratory).
2. Patients who have shown thromboembolic events with an appropriate INR.
3. Known hypersensitivity to LMWH, heparin or substances of porcine origin.
4. Patients with organic lesions susceptible to bleeding (e.g. active peptic ulcer, stroke, aneurysms).
5. Patients with a history of heparin-induced thrombocytopenia.
6. Patients with suspected inability/or inability to comply with treatment and/or complete the study.
7. Patients who are participating in another clinical trial or have been participated in the past 30 days.
8. Patients with antithrombin deficit and C and S protein deficit
9. Women who are pregnant or breast-feeding, or with the possibility of becoming pregnant during the study.
10. Acute bacterial endocarditis or slow endocarditis.
11. Severe arterial hypertension (systolic blood pressure over 200 mmHg and/or diastolic blood pressure over 120 mmHg).
12. Patients with antiplatelet therapy
13. Patients with mechanical cardiac valves in mitral position and body weight 90 Kg with/or bone mass index (BMI) \> 30 or 50 kg
14. Patients with Starr-Edwards valves.
Pharmacokinetics of Doxorubicin in cTACE of Liver Cancer

Patients with primary and secondary liver cancer may participate in this study. The purpose is to perform an analysis of the effects of doxorubicin and its metabolite doxorubicinol on the body (doxorubicin pharmacokinetics ) after conventional transarterial chemoembolization (cTACE). cTACE is a procedure in which chemotherapy drugs are injected, followed by an injection of small beads to block the tumor-feeding arteries. Doxorubicin is a chemotherapeutic agent used in the cTACE procedure. This study will examine doxorubicin pharmacokinetics in patients who: 1) receive whole liver cTACE; and 2) receive super-selective CTACE (i.e., delivered in close proximity to the tumor).

Patients with primary and secondary liver cancer may participate in this study. The purpose is to perform an analysis of the effects of doxorubicin and its metabolite doxorubicinol on the body (doxorubicin pharmacokinetics ) after conventional transarterial chemoembolization (cTACE). A pharmacokinetics profile (PK profile) will be constructed and will include peak of plasma concentration (Cmax), time of maximum concentration (TMax), and area under the concentration curve (AUC). This composite measure will be used to compare patients in cTACE lobar administration and cTACE superselective administration. In addition, the PK profile will be correlated with toxicity, tumor burden, body surface area, and gender. Feasibility and safety will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. Histologically, cytologically, or radiologically confirmed liver dominant or liver only malignancy.
3. Preserved liver function (Child-Pugh A-B class) without significant liver decompensation.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 at study entry.
5. Measurable or evaluable disease that will be directly treated with intrahepatic therapy (as defined by Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1).
6. Suitable for TACE based on blood parameters such as platelet count, bilirubin, and international normalized ratio.
7. May be enrolled with a history of prior liver directed intra-arterial therapy if intra-arterial therapy to the target lesion occured \> 1 year prior to enrollment date. Intra-arterial therapy to different targets within 1 year prior to enrollment date will not exclude subjects.

Exclusion Criteria:

1. Serum total bilirubin \> 3.0 mg/dL
2. Creatinine \> 2.0 mg/dL
3. Platelets \< 50000/µL
4. Complete portal vein thrombosis with reversal of flow
5. Ascites (trace ascites on imaging is acceptable)
Daily Duration of Compression Treatment in Patients With Symptomatic Chronic Venous Disease

Aim of study is to investigate the optimal duration and daily regimen of compression treatment in patients with chronic venous disease


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic chronic venous disease
* C0-C4 according to CEAP-classification

Exclusion Criteria:

* C5-C6 according to CEAP-classification
* Intolerance to compression socks
* Patient's unwillingness to use compression socks
* Inability to use compression socks
The Health Impact of Mindfulness Based Stress Reduction on Total Knee Arthroplasty

Despite surgical success of total knee arthroplasty (TKA), reports of dissatisfaction and poor outcomes including increased pain, reduced function for daily activities, and compromised psychological health are common. Interventions to improve TKA outcomes are primarily education-focused, however there is little support for efficacy. Evidence suggests that mindfulness based stress reduction (MBSR) is effective for improving both physical and mental health, which are factors implicated in negative post-operative TKA outcomes. The efficacy of this empirically supported intervention on TKA outcomes has not been assessed. The proposed pilot study will conduct a randomized controlled trial to evaluate the feasibility and efficacy of pre-surgical MBSR on post-surgical outcomes. Post-operative pain (severity and catastrophizing), functioning (interference and illness impact), quality of life, emotional distress (anxiety and depression) and sleep will be assessed in pre-surgical MBSR and compared to treatment as usual. This pilot will provide an opportunity for TKA patients to receive an intervention that may improve outcomes. Further, it will provide insight into the relationship between pre-surgical MBSR and post-operative TKA outcomes, which will assist in the development of MBSR adaptations to less time intensive, and potentially more accessible, future offerings.

Forty-five participants on the waitlist for a TKA will be recruited from Concordia Hospital Hip and Knee Institute - a facility that performs 800 TKA's per year. Participants will be divided into two groups: the pre-operative MBSR group (30 participants, divided into two MBSR groups), and the treatment-as-usual (TAU;15 participants). The individuals in the pre-operative MBSR group will receive a pre-operative 8-week community-based MBSR course taught by a certified instructor, which includes group classes lasting 2.5 hours a week, 45-minutes of home practice 6 days per week, a 1-hour orientation session at the beginning, and a full-day silent retreat at the end. During the orientation, participants will complete the study measures for this study. Two weeks prior to the surgery at the pre-anesthesia clinic, all patients will receive another set of short self-reported questionnaires. All patients will subsequently receive post-operative questionnaires at the following regularly scheduled post-operative appointments: 6-8 weeks after surgery, and at 6 month and 1 year follow-ups. Clinic personnel, who are blinded to assignment, will administer these measures with all other regularly distributed clinical measures. Clinic personnel will also review the chart to inform researchers as to what physical condition contributed to the need for a TKA. The TAU group will have the opportunity to enroll in an MBSR course following the completion of the study (after approximately 1 year), at no cost.

Eligibility Criteria:
Inclusion Criteria:

* on waitlist for first TKA

Exclusion Criteria:

* on waitlist for revision TKA
* taken a mindfulness course in the past 2 years
* not able to read or understand English
fMRI Study of the Cerebal Bases of the Spatialization Process in Working Memory

The present neuroimaging study investigates cerebral and behavioral markers of spatialization. Spatialization in memory corresponds to a mental representation of successive items from left to right in Westerners. A simple task to detect spatialization consists in presenting a series of stimuli sequentially. All stimuli are centered on the screen, so there is no spatial information during the task. After the presentation of the sequence, there is a recognition phase in which the participant is requested to take a decision as to whether a memory probe belongs to the sequence maintained in memory. The decision is made by pressing a key with the left or the right hand, depending on the instruction. The main measure is the difference in response times between the two hands. The standard spatialization effect in working memory in Westerners is that left-key responses are faster when retrieving the first items of the sequence whereas later items elicit faster right-key responses. To date, the factors that can influence this spatialization process in working memory as well as the brain structures involved remain largely unknown. Participants need to complete three experimental conditions associated with fMRI recording of brain activity. In task A (Visual Spatial), participants will see the sequences presented from left to right; in task B (Visual No Spatial), participants will see sequences of items presented in the middle of the screen; and in task C (Auditory), the sequences will be presented in an auditory format. When comparing tasks, A and B, we will be able to investigate if seeing information from left to right (spatialization is provided through the spatial coordinates of the items) is comparable to spatializing information from left to right (spatialization is not provided, all items have the same spatial coordinates). The comparison between task B and C will allow us to investigate the effect of seeing items (spatialization is not provided, all items have the same spatial coordinates) versus hearing them (spatialization is not provided and items have no spatial coordinates).


Eligibility Criteria:
Inclusion Criteria:

* right-handed adult subjects
* between 18 and 35 years of age,
* affiliated to or benefiting from a social security system
* having signed a prior informed consent.

Exclusion Criteria:

* minors
* subjects aged 36 years and older,
* left-handed,
* neurological disorders contraindicating fMRI examinations,
* protected by law under guardianship or curatorship, or unable to participate in a clinical study under Article L. 1121-16 of the French Public Health Code.
A Study of Safety and Efficacy of PET-adapted Treatment With Nivolumab at the Fixed Dose 40 mg, Ifosfamide, Carboplatin, Etoposide (NICE-40) in Patients With Relapsed/Refractory Hodgkin Lymphoma

Nivolumab is an anti-PD-1 antibody highly effective in patients with relapsed/refractory classical Hodgkin lymphoma. A PET-adapted regimen of Nivo combined with ICE as first salvage therapy was shown to induce high response rates and favorable progression-free survival as a bridge to autologous stem cell transplantation, allowing to omit salvage chemotherapy in a substantial proportion of r\\r cHL patients. This study evaluates the safety and efficacy of PET-adapted treatment of nivolumab at the fixed dose of 40 mg in combination with ifosfamide, carboplatin, and etoposide (NICE-40) in patients with relapsed/refractory Hodgkin Lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis: Histologically confirmed Hodgkins lymphoma
* Relapsed or refractory disease after the first line of treatment
* Age 18-70 years old
* Ejection fraction greater than 50%
* ECOG 0-2 status
* Signed informed consent
* No severe concurrent illness

Exclusion Criteria:

* Uncontrolled bacterial or fungal infection at the time of enrollment
* Requirement for vasopressor support at the time of enrollment
* Severe organ failure: creatinine more than 2 norms; ALT, AST more than 5 norms; bilirubin more than 1.5 norms
* Karnofsky index \<30%
* Pregnancy
* Somatic or psychiatric disorder making the patient unable to sign an informed consent
* Active or prior documented autoimmune disease requiring systemic treatment.
Vitamin D Supplementation in Healthy Adolescents

This double blind, randomized controlled trial compares two supplemental doses of vitamin D in health adolescents.

Vitamin D deficiency is a common problem. Currently, data do not support a recommended vitamin D supplementation dose for health adolescents to maintain normal vitamin D levels. This double blind, randomized controlled 12 week trial compares the use of two supplemental doses of vitamin D in this population.

Eligibility Criteria:
Inclusion Criteria:

* 11-18 years old
* healthy

Exclusion Criteria:

* chronic disease
* use of medication known to effect bone or vitamin D metabolism
* abnormal vitamin D or calcium at screening
* pregnant
* body mass index \<5% or \>95%
Performance Characteristics and Safety Assessment of a Non-invasive Glucose Monitoring Device

This clinical study has been launched to collect spectral raman data paired with validated glucose reference values in private homes of subjects.

Subjects will collect spectral raman data on device every 15 minutes for 10 hours a day for five days. The five days will be distributes with in a timeframe of ten days. A Flash Glucose Monitor will be used as a comparator. In addition to this, four daily capillary Blood Glucose readings will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects 18 years of age or older
* Diabetic patients (all types)

Exclusion Criteria:

* Pregnant women
* Subjects not able to understand and read Danish
* In investigator's opinion, subject is not able to follow instructions as specified in the protocol
* Subjects not able to hold hand/arm steadily
* Extensive skin changes, tattoos or diseases on probe application site
* Known allergy to medical grade alcohol used to disinfect skin
The Beneficial Effect of TJ-134 for Patients With Symptomatic Pneumatosis Cystoides Intestinalis

The traditional Japanese medicine, Keishi-ka-shakuyaku-daio-to is administered to patients with symptomatic pneumatosis cystoides intestinalis (PCI) as compared with lactomin for 8 weeks.

1. Based on endoscopic finding, patients with symptomatic PCI are recruited.
2. After enrollment, abdominal symptoms are evaluated and abdominal CT is performed.
3. Patients were randomized in a 1:1 ratio in blocks of 4 to undergo either the traditional Japanese medicine or lactomin (control). Randomization was carried out by computer-generated random sequences.
4. The traditional Japanese medicine, Keishi-ka-shakuyaku-daio-to（TJ-134, 7.5g/day), which consists of a mixture of a compound of peony root (6 g), cinnamon bark (4 g), jujube (4 g), glycyrrhiza (2 g), rhubarb (2 g), and ginger (1 g) or lactomin (3g/day) is administered to enrolled patients for 8 weeks.
5. After the administration of each drug for 8 weeks, abdominal symptoms are evaluated and abdominal CT is performed again.

Eligibility Criteria:
Inclusion Criteria:

* typical findings of PCI on colonoscopy; Line or pebble like sessile cysts are distributed around the colon with normal overlying mucosa

Exclusion Criteria:

* patients can not take Keishi-ka-shakuyaku-daio-to（TJ-134）
Scoring System of Structural Damage for the Hip in Juvenile Idiopathic Arthritis

Juvenile idiopathic arthritis (JIA) is a chronic inflammatory disease in children affecting mobility and physical function. The hip involvement represents a frequent complication in JIA patients. The assessment of hip damage becomes a mandatory step in disease monitoring. However, radiological scoring was not standardized. This study aimed to compare the two scoring systems previously proposed, examine their repeatability and their intra and inter agreement.


Eligibility Criteria:
Inclusion Criteria:

* All included patient followed the ILAR criteria of JIA and have a hip involvement. This later was defined as the presence of rang motion limitation, and abnormal findings in pelvic radiographic, or ultrasound or MRI in the coxo-femoral joint.

Exclusion Criteria:

* The presence of a contraindication to the performance of conventional radiography any disease affecting cognition Patients who have had surgery on the hip