cyrilzakka/clinical-trials huggingface dataset:
Gene-activated Matrix for Bone Tissue Repair in Maxillofacial Surgery

The purpose of this study is to evaluate safety and efficacy of gene-activated matrix ("Nucleostim") for regeneration of bone tissue in maxillofacial area. Patients with congenital and acquired maxillofacial defects (sockets of extracted teeth, bone defects after injuries, surgeries, excision of benign neoplasms and pseudotumors, etc.) or alveolar bone atrophy will be included into the study.

All patients enrolled into the study will receive standard surgery procedures indicated in accordance with medical care standards for the certain disease. Maxillofacial bone defects (formed after injuries, surgeries, excision of benign neoplasms and pseudotumors, teeth extraction, etc.) or areas of alveolar bone atrophy will be the filled by gene-activated matrix "Nucleostim". Safety and efficacy of implanted osteoplastic material will be assessed by physical examination, comprehensive laboratory tests, X-ray examination within 60 days after operation.

Eligibility Criteria:
Inclusion Criteria:

* obtained voluntary informed consent for participation in the clinical study;
* congenital and acquired maxillofacial bone defects (sockets of extracted teeth, bone defects after injuries, surgeries, excision of benign neoplasms and pseudotumors, etc.) or alveolar bone atrophy.

Exclusion Criteria:

* not able or unwilling to give voluntary informed consent for the study or follow requirements of the clinical study;
* decompensated chronic visceral diseases;
* clinically significant laboratory abnormalities;
* HIV, HBV and HCV antibodies in serum;
* alcohol consumption within 4 days prior the study;
* history of drug addiction;
* participation in other clinical studies (or administration of study products) within 3 months prior the study;
* conditions limiting study compliance (dementia, psycho-neurological diseases, drug addiction, alcoholism, etc.);
* malignancies including post-surgical period with chemo- and (or) radiation therapy);
* vascular malformations;
* pregnancy or lactation.
Compassionate Use of Stiripentol in Dravet Syndrome

Compassionate use of Stiripentol in Dravet Syndrome. This is a treatment protocol, not a research study, therefore children will only be monitored on a clinical basis for seizure improvement predominantly by parent and caregiver report.

This is a treatment protocol for compassionate use, not a research study, therefore children will only be monitored on a clinical basis for seizure improvement predominantly by parent and caregiver report.

Eligibility Criteria:
Children with genetic confirmation of Dravet syndrome (a documented sodium channel, voltage-gated, type I, alpha subunit (SCN1A) mutation) or clinical confirmation of Dravet syndrome by two pediatric neurologist will be considered to have Dravet syndrome. In order to enter the treatment protocol there will be documented treatment failure of at least two therapeutic anticonvulsants excluding Na channel blockers. Anticonvulsants that are Na channel blockers such as carbamazepine and lamotrigine as known to provoke seizures in this patient population.
Evaluation of a Smartphone-based Screening Tool for Neonatal Jaundice in a Ugandan Population

The general objective of this study is to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns at HICH Mbarara.

The general objective of this study is to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns at HICH Mbarara.

The specific objectives for this study are:

To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin measurements in serum in newborns with varying degree of jaundice To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin estimates from a standard transcutaneous device in newborns with varying degree of jaundice To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns with varying degree of jaundice

Eligibility Criteria:
Inclusion Criteria:

* Infants born with gestational age ≥37 weeks
* Birth weight ≥2000g and ≤4500g
* Age 1 - 14 days
* Infants requiring a blood sample (newborn screening / clinically suspected jaundice)

Exclusion Criteria:

* Infants transferred to the paediatric ward for advanced treatment.
* Infants with a skin rash or other disease that affects the skin where measurements are performed.
* Infants that receive or have received phototherapy in the last 24 hours.
* Infants with an inborn disease
Evaluation of NETs in Patients With Solid Cancers Associated With a High Risk of Venous Thromboembolic Events

Venous Thromboembolic Events (ETVs) are the second leading cause of death (9.2% of causes of death) in cancer patients after tumor progression (1). Indeed, cancer is associated with a 4 to 7-fold risk of ETV during chemotherapy (2). This complication is observed in 20% of cancer patients (3), and is sometimes an inaugural manifestation of cancer. This risk is particularly increased during the first 3 months after cancer diagnosis (4).

A biomarker correlated with the occurrence of ETVs would make it possible to target patients at high risk of thrombosis who could benefit from primary thromboprophylaxis, thus avoiding the complications, particularly haemorrhagic, and the additional costs associated with the long-term diagnostic and therapeutic management of ETVs. The investigator has implemented in the laboratory an innovative approach to the detection and quantification of circulating NETs by flow cytometry (FCM) allowing the routine determination of NETs. Therefore the investigator propose to assess NETs by CMF in a cohort of cancer patients with a very high risk of ETVs (pancreatic cancer, gastric cancer and colon cancer).

The NETs will be detected and quantified by CMF on the remaining EDTA tube collected to perform the blood count (NFS), using the method in place in the laboratory, adapted from the method initially described by Gavillet et al. The analyses will be carried out on a Fortessa LSR cytometer (Becton Dickinson), the antibodies used are specific to NET components: citrullinated H3 anti-histone in indirect labelling coupled APC, PE myeloperoxidase and Hoescht 34580 as DNA marker. The level will be measured in NETs/µL of whole blood as a function of the white blood cell count (Sysmex XN-3000). In parallel, other parameters associated with ETV risk will be evaluated: NFS on Sysmex-XN PLC, D-dimers, FVIII and MP. The assays of PM, D-dimers and FVIII will be performed specifically as part of the project, the other parameters will be measured as part of routine patient management and will not result in any additional constraints or costs. Biomarker assays will be performed at the time of cancer diagnosis on the EDTA and citrate tubes collected for NFS and TP/TCA respectively as part of routine care.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female over 18 years of age (≥18),
* Patient with pancreatic, gastric or colorectal cancer,
* Patient with a high risk of ETV,
* Patient on the first line of treatment or relapsing after a period of complete remission,
* Patient affiliated to a social security system or CMU.

Exclusion Criteria:

* Patient who has had an ETV in the 3 months prior to inclusion,
* Patient with a life expectancy of less than 3 months,
* Patient with an anticoagulation placement,
* Known pregnant or breastfeeding woman,
* Patient under guardianship or curatorship.
The Incidence and Progression of Myopia: Cohort Study

A cohort study on incidence and progression of myopia in a group of medical students

A prospective cohort study to investigate the refractive error development, progression and their risk factors in young adult population comprises a group of medical students in China for two years

Eligibility Criteria:
Inclusion Criteria:

* Volunteer subject, , willing to follow the protocol and able to read, comprehend and sign the informed consent form,
* Age between 17 and 23 years

Exclusion Criteria:

* Vulnerability of the subject,
* Participation in another study which might have an influence on vision or interfere with study assessments,
* Aphakic or pseudophakic (intraocular lens)
* Participants who are wearing ortho-K lenses, or undergone any kind of myopia control treatments or undergone refractive surgery.
* Any current or evolving pathology manifested in the eye or the appendages which might have an influence on vision, or interfere with study assessments (e.g. AMD, glaucoma...),
* Any previous ocular surgery which might have an influence on vision or interfere with study assessments (e.g. iridectomy, refractive surgery...),
* Any untreated and/or uncontrolled systemic condition which might have an influence on vision, or interfere with study assessments (e.g. uncontrolled diabetes, uncontrolled high blood pressure...),
* Any medical treatment or medication which might have an influence on vision or interfere with study assessments (e.g. antidepressants, drugs with atropinic effects...),
IVIG Treatment for Asthmatic Patients With IgG Subclass Deficiency

Immunoglobulin G deficiency subtypes in patients with asthma six months once a month intravenous immunoglobulin (400mg/kg/4weeks) infection in treatment-related effect on reducing the frequency of asthma exacerbations appreciate.

Patients Registration

•It is required to ensure that the patients meet the inclusion criteria for this clinical trial, are free from any items of exclusion criteria, are explained about the participation in the clinical trial along with the informed consent forms.

Procedure

•six months once a month intravenous immunoglobulin (400mg/kg/4weeks)

Eligibility Criteria:
Inclusion Criteria:

* The patient from over 16 years to under 75 years
* Patients diagnosed with asthma over six months ago
* immunoglobulin G subtypes who were diagnosed with immune deficiency
* more than 2 years Upper and lower respiratory tract infections

  , and asthma exacerbations in this regard.
* ① calculated creatinine clearance ≧ 50ml/min

  * ALT and AST \<x 3 times the upper limit of normal

    * ALP \<x 3 times the upper limit of normal

      * total bilirubin \<x 1.5 times the upper limit of normal

Exclusion Criteria:

* within six months of the onset of the experiment who received immunoglobulin therapy
* immune globulin for those with a history of hypersensitivity reactions
* six months ago, another clinical trial participants.
* Systemic steroids and immunomodulators, such as asthma control that may affect the resources required drug administration.
* pregnant or lactating women.
Weight Changes Among Martinican Prisoners

Assessment of body weight change among prisoners in Martinique between admission in jail and 3 months later expressed as a percentage of admission weight. Intensity of physical activities, nutrition intakes and psychological state are also studied to describe associated factors to body weight change.

Several studies described how weight of prisoners may vary during incarceration. Taking or losing weight both have health consequences but are also a warning signal for several pathologies. Female prisoners are more likely getting fat, data are rare and contradictory about male prisoners. A single study was conducted in mainland France and including few men. Furthermore, Martinique is a department where the prevalence of overweight and diabetes in the general population are higher than the national average. Prisoners most often have socio-demographic featuring and morbidity different from the general population (more men, some over-represented age groups, addictive behaviors and more frequent mental health problems ...). Aspects nutritional information is less often documented. What about the weight variation of people held in Martinique? Is incarceration always accompanied by weight gain? What are factors associated with weight variation? This study aims to answer to those questions by including all men newly admit in the only martinican jail aged from 18 to 44 years and consenting. During admission medical consultation, prisoners will fill guided by the investigator doctor of self-questionnaires of the evaluation of the level of physical activity, assessment of nutritional intakes and psychological state before incarceration. Measurement of weight and other anthropometrics data will be done, investigator doctor will collect data about socio-economic featuring, medical history and treatment. Three months later, a research technician will interview included prisoners in their life place and guide them to fill new self-questionnaires of the evaluation of the level of physical activity, assessment of nutritional intakes and psychological state during incarceration. Measure weight and other anthropometrics data and collecting data about new treatment, stopping tobacco will be done during this interview.

Eligibility Criteria:
Inclusion Criteria:

* all men newly incarcerated in martinican jail during inclusion period
* age between 18 and 44 years old
* having given his consent

Exclusion Criteria:

* female
* 44 years old and up
* not understanding or speaking French or English
A Study to Collect and Evaluate the Safety and Efficacy Information of Korean Multiple Myeloma Patients Treated With REVLIMID®, After Approval of Marketing Authorization for New Drug in Korea

The main purpose of REVLIMID® DUE (Drug Use Examination) is to collect and evaluate the safety information of Korean Multiple Myeloma patients treated with REVLIMID® according to the approved package insert, after approval of marketing authorization for new drug in Korea. In addition, the efficacy information of REVLIMID® in clinical practice is collected and evaluated. This DUE is a multi-centre, observational and non-interventional post-marketing surveillance.

The patients can be recruited through both Drug Use Examination after the initiation of Post Marketing Surveillance(contract with institution) and Patient Access Program(PAP) that was performed before REVLIMID® reimbursement.

Total 624 patient has enrolled in PMS by 07Sep2016. Validation process for eligibility for safety assessment has been conducted by site monitoring process by 07Dec2016.

REVLIMID® DUE is to investigate frequency and change of Adverse Events(AEs) /Adverse Drug Reactions(ADRs), Serious Adverse Events(SAEs)/Serious Adverse Drug Reactions(SADRs), unexpected AE/ADR and unexpected SAE/SADR, and to scrutinize factors influencing safety \& efficacy of the drug.

It is necessary to examine patients' demographics and baseline characteristics, medical history, status of REVLIMID® treatment, concomitant medication and evaluation of safety and final efficacy (best response) assessment.


Eligibility Criteria:
Inclusion Criteria:

* Korean male or female who are diagnosed with Multiple Myeloma
* In-patients or out patients during the REVLIMID® Drug Use Examination period who are intended to be treated with REVLIMID ®
* Patients who are registered for Risk Management Program of Celgene

Exclusion Criteria:

* There's no exclusion criteria
Debate on Progesterone Elevation on the Day of Triggering

The association between serum progesterone (P) levels, measured on the day of ovulation trigger, and the outcome of in vitro fertilization cycles, has been one of the major controversies in the field of ovarian stimulation endocrinology.

This is a single-center retrospective cohort study. Study duration period is from January 2012 to December 2016.

All fresh embryo transfer (ET) both at cleavage stage and blastocyst stage, performed in Humanitas Fertility Center during the study period, were included.


Eligibility Criteria:
Inclusion Criteria:

* All fresh embryo transfers both at cleavage stage (Day 2 and Day3) and blastocyst stage (Day 5)
* Thawed embryo transfer deriving from supernumerary embryos cycles, by P increase, by OHSS, by other reasons (i.e inadequate endometrium, medical complications, etc)

Exclusion Criteria:

* thawed embryo transfers deriving from PGTA.
Study of AOC 1001 in Adult Myotonic Dystrophy Type 1 (DM1) Patients

AOC 1001-CS1 is a randomized, double-blind, placebo-controlled, Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple-doses of AOC 1001 Administered Intravenously to Adult Myotonic Dystrophy Type 1 (DM1) patients (MARINA).

Part A is a single dose design with 1 cohort (dose level). In Part A, the patient duration is 6 months as the treatment period is 1 day followed by a 6 month follow-up period.

Part B is a multiple-ascending dose design with 2 cohorts (dose levels). In Part B, the patient duration is 6 months as the treatment period is 3 months followed by a 3 month follow-up period.


Eligibility Criteria:
Key Inclusion Criteria:

* Genetic diagnosis of DM1 (CTG repeat length ≥ 100)
* Clinician assessed signs of DM1
* Ability to walk independently (orthoses and ankle braces allowed) for at least 10 meters at screening

Key Exclusion Criteria:

* Diabetes that is not adequately controlled
* BMI \> 35 kg/m2
* Uncontrolled hypertension
* Congenital DM1
* History of tibialis anterior (TA) biopsy within 3 months of Day 1 or planning to undergo TA biopsies during study period
* Recently treated with an investigational drug
* Treatment with anti-myotonic medication within 14 days of Day 1

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Protocol for The Lipid Registry of Africa

The Lipid Registry of Africa (LIPRA) aims to understand why some individuals in Africa experience heart issues at a younger age than others. The study investigates factors causing heart problems in younger adults, particularly acute coronary syndrome (ACS). Acute coronary syndrome (ACS) includes various heart conditions like unstable angina and heart attacks. Researchers from multiple African countries collaborate to gather information from hospitals across the region. They focus on patients under 55 years (men) or 65 years (women) with heart issues.

Additionally, the study wants to compare different groups-men and women, urban and rural residents-to see if there are specific differences in how heart problems develop among them.


Eligibility Criteria:
Inclusion Criteria:

* Individuals diagnosed with premature Acute Coronary Syndrome (ACS) within the defined age range (≤55 years in men and ≤65 years in women).
* Patients admitted to designated cardiac facilities in Africa (Urban and rural).
* Diagnosed cases of ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction/unstable angina pectoris (NSTEMI/UAP) based on predetermined criteria including symptoms, electrocardiogram (ECG) alterations, and biomarker levels.
* Patients exhibiting an increase (above the 95th percentile) or decrease in serum troponin levels as per admission standards.

Exclusion Criteria:

* Individuals outside the defined age range for premature Acute Coronary Syndrome (ACS) diagnosis.
* Patients not admitted to designated cardiac facilities in Africa.
* Diagnosed cases not meeting the specified criteria for Acute Coronary Syndrome (ACS) subtypes (STEMI, NSTEMI/UAP) based on symptoms, electrocardiogram (ECG), and biomarker levels.
Coagulation in Cirrhosis

Out of fear of bleeding, liver cirrhosis patients are often treated prophylactically with blood and coagulation products before minor interventions. The COUCH study will examine whether these patients benefit from a restrictive administration of coagulation products.

Patients with cirrhosis commonly have deranged coagulation parameters, in particular thrombocytopenia and/or an increased INR. However, these laboratory findings do not necessarily correlate with an increased tendency of bleeding. In fact, the reduced synthesis of both pro- and anticoagulant factors often equates to a new equilibrium in the coagulation system. Nevertheless, out of fear of bleeding, liver cirrhosis patients with deviated laboratory coagulation parameters are often aggressively treated with coagulation products (such as platelet concentrates and prothrombin complex concentrate (PCC)) before minor interventions and punctures. Since these products can also have procoagulant side effects, we will investigate whether patients with liver cirrhosis without a history of bleeding or clinical bleeding signs benefit from a restrictive substitution regime. The study will be carried out monocentrically at the General Hospital of Vienna, and will include 400 patients divided into two groups (liberal vs. restrictive substitution of thrombocytes and/or PCC) over an est. period of 4 years.

Eligibility Criteria:
Inclusion Criteria:

Patients at the University Hospital of Vienna with diagnosed liver cirrhosis and deranged coagulation parameters (INR \>1,5 AND/ OR platelet count \<50 G/L) who are scheduled for one of the following elective invasive interventions of the liver

* Biopsy or puncture
* Microwave ablation (MWA) or radiofrequency ablation (RFA)
* Transjugular intrahepatic portosystemic shunt (TIPS)
* Percutaneous transhepatic cholangiography drain (PTCD)

Exclusion Criteria:

* Missing informed consent or inability to consent
* Age \< 18 years
* Pregnancy or breastfeeding
* Manifest ascites
* Chronic kidney injury stage G4 or G5, KDIGO
* Uninterrupted anticoagulant therapy, except for acetylsalicylic acid (ASA)
* History of bleeding or clinical signs of a hemorrhagic diathesis in the physical examination (e.g., petechia, ecchymosis, mucosal bleeding, hemorrhagic diathesis within the family, menorrhagia, prolonged bleeding after surgery)
Evaluation to Assess the Long Term Safety of Tacrolimus Ointment for Atopic Dermatitis

To assess the long-term safety of tacrolimus ointment

To assess the long-term safety of tacrolimus ointment 0.03% or 0.1% in the treatment of subjects with atopic dermatitis under actual use conditions, including the risk of developing cutaneous or systemic malignancies. The FDA and EMEA approved Tacrolimus ointment, 0.03% in children and 0.1% and 0.03% in adults, for the treatment of atopic dermatitis. As part of the approval process, the FDA and EMEA requested a post-marketing commitment regarding the safety of long-term use of Tacrolimus ointment in pediatric atopic dermatitis subjects.

Eligibility Criteria:
Inclusion Criteria:

* Subject has/had atopic dermatitis.
* Subject has applied tacrolimus ointment 0.03% or 0.1% for at least 6 weeks, continuously or intermittently. This may include subjects who have been enrolled in previous tacrolimus ointment studies and/or subjects with commercial product exposure prior to study enrollment.
* Subject age at the first tacrolimus ointment exposure is/was \<16 years of age.
* Subject/Caregiver has given written informed consent and assent as required by state and/or governmental laws, including access to all relevant clinical and medication data, and the storage and analysis of these data.
* Subject/Caregiver agrees to comply with the program requirements including an annual physical exam and biennial dermatological exam and agrees to be contacted and provide information as described in this document to Primary Investigator Dr. Lamb and Covance Periapproval Services, Inc.

Exclusion Criteria:

* Subjects who do not have/ have not had Atopic Dermatitis.
* Subjects must have used Tacrolimus ointment prior to age 16.