cyrilzakka/clinical-trials huggingface dataset:
Objective Study in Rheumatoid Arthritis

Primary Objectives

1. To test the feasibility, in patients with active rheumatoid arthritis, of using an 'aggressive' treatment algorithm to bring a short term treatment objective (STO) within the normal or an arbitrarily defined 'desirable' range.
2. To determine whether patients with active rheumatoid arthritis randomly allocated to a particular STO show a reduced rate of Magnetic resonance imaging damage progression at two years compared to those randomly allocated to usual care.

Secondary Objectives

1. To establish the relationship between achieving a given STO or combination of STOs and damage progression.
2. To identify the characteristics of responders and non-responders with respect to STO achievement and predictors of greater and lesser degrees of damage progression.


Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid Arthritis as defined by the American College of Rhemuatology criteria and either
* Active disease: ≥6/28 swollen joints or
* Erythrocyte sedimantation or C-Reactive Protein \> normal
* Disease duration ≤ 15 yrs
* Any therapy
* Females of child-bearing potential must be adequate contraception

Exclusion Criteria:

* Frailty, limiting co-morbidity
* Obesity limiting ability to have MRI
* Geographical difficulty preventing follow-up and visits
* Women at risk of becoming pregnant

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Glycoprotein IIb/IIIa Inhibitors Versus Standard Therapy in Patients with Myocardial Infarction and No-reflow

Aim of the study is to examine the effects of glycoprotein IIb/IIIa inhibitors on reperfusion success assessed by cardiac magnetic resonance imaging in patients with myocardial infarction and angiographic evidence of no-reflow.


Eligibility Criteria:
Inclusion Criteria:

* ST-elevation myocardial infarction and non-ST-elevation myocardial infarction \<48 h after symptom onset
* Angiographic evidence of no-reflow (Thrombolysis in Myocardial Infarction-flow grade ≤2) after primary percutaneous coronary intervention
* Age ≥18 years
* Informed consent

Exclusion Criteria:

* ST-elevation myocardial infarction and non-ST-elevation myocardial infarction patients with Thrombolysis in Myocardial Infarction-flow 3 after primary percutaneous coronary intervention
* Age ≤18 years
* Known pregnancy, breast-feeding or intend to become pregnant during the study period
* Contraindication for treatment with platelet inhibitors
* Known allergy to glycoprotein IIb/IIIa inhibitors, aspirin, or heparin
* Active peptic gastric or duodenal ulcer
* History of major surgery (including intracranial or intraspinal) \<4 weeks
* Active bleeding or bleeding diathesis
* Stroke \<2 years (ischemic and hemorrhagic)
* Known coagulation defect or relevant thrombocytopenia
* Arteriovenous malformations or aneurysm
* Severe liver insufficiency
* Renal insufficiency requiring dialysis
* Uncontrolled hypertension
* Hypertensive retinopathy
* Vasculitis
* Fibrinolysis \<12 hours
* Contraindication for cardiac magnetic resonance imaging at study entry
* Patients without informed consent
* Participation in another trial
Prognosis Assessment of the Increase of GADD34 Gene Expression for Patient Suffering From Systemic Lupus Erythematosus

Given that GADD34 has been described as a potential key regulator of pro-inflammatory cytokine production in human and elevated blood marker in SLE patients, this study aim to prove that the GADD34 RNA level in mononuclear blood cells can be used as a prognostic marker to assess the risk of SLE flare.

Systemic lupus erythematosus (SLE) has a prevalence estimated between 1 and 6 per 10000 individuals and concerns over 30 000 patients in France for example. As of today, there isn't any reliable specific blood analysis that can be used to assess the prognosis of SLE, that means predict a SLE flare. The discovery of such a blood test could allow a better patients' monitoring in order to help doctors to better adapt treatments (lowering background treatments when they are not needed and increase them ahead of a potential flare when the risk assessment raises).

In SLE patients, a recent study shows elevated levels of GADD34 RNA in mononuclear blood cells : higher than twice the control levels for 36 of the 60 SLE patients and ten times higher than the control levels for 13 of the 60 SLE patients.

Given that GADD34 has been described as a potential key regulator of pro-inflammatory cytokine production in human and elevated blood marker in SLE patients, this study aim to prove that the GADD34 RNA level in mononuclear blood cells can be used as a prognostic marker to assess the risk of SLE flare.

Eligibility Criteria:
* Inclusion Criteria:

  * man and women over 18 Years old.
  * suffering from SLE (American College of Rheumatology criteria).
  * without SLE flare for 3 months.
  * with a signed consent and social security affiliation (required in France).
* Exclusion Criteria:

  * Viral infection within 15 days.
  * Other chronic inflammatory disease.
  * People with special protection (defined in articles : L1121- §5-8 et articles L3212-§1-3 of French health care law).
Compassionate Use Ponatinib

The main purpose of this protocol is to provide expanded access to the study drug (Ponatinib/AP24534) for people with imatinib-, dasatinib-, and nilotinib- resistant/intolerant Philadelphia Chromosome Positive (Ph+) Leukemias. The other purpose of this protocol is to monitor the safety of the study drug in people with Ph+ Leukemias that have not responded to prior treatment.


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent
* Cytogenetic or PCR-based diagnosis of any phase of Ph+ acute lymphoblastic leukemia (ALL) and documented resistance or intolerance to imatinib and a second TKI (nilotinib, dasatinib, bosutinib)
* Eastern Cooperative Oncology Group(ECOG) performance status of 0-2
* Washout from prior anti-proliferative or anti-leukemia treatment: 3 days for hydroxyurea/anagrelide and tyrosine kinase inhibitors
* \< Grade 2 or baseline recovery from prior therapy related toxicities (except alopecia)
* At least 3 months post allogeneic stem cell transplantation
* Able to take oral capsules reliably
* AST/ALT less than or equal to 2.5 times ULN, or less than 5 times ULN if attributable to involvement of leukemia
* No active clinical or radiographic pancreatitis
* At least 18 years of age
* Willingness of male and female subjects to use reliable methods of birth control (when applicable)

Exclusion Criteria:

* Subjects with Philadelphia Chromosome and BCR-ABL-negative chronic myeloid leukemia (CML)
* Major surgery or radiotherapy within 7 days before the first dose of Ponatinib (recovery from any previous surgery should be complete before day 1)
* Clinically significant active/uncompensated or uncontrolled cardiac disease (active congestive heart failure; uncontrolled angina or hypertension; myocardial infarction in the past 3 months; clinically significant untreated ventricular arrhythmia; diagnosed or suspected congenital or acquired prolonged QT syndrome; unexplained syncope; history of prolonged QTc)
* Prolonged QTc (\> 0.48 sec)
* Pregnant or breastfeeding women
* Evidence of serious active infection, or significant medical or psychiatric illness
* Known seropositivity to HIV, or current acute or chronic Hepatitis B or Hepatitis C (antigen positive), cirrhosis, or clinically significant abnormal lab finding that would, in the investigator's judgment, make the subject inappropriate for this study
* Prior resistance to Ponatinib
Totally Laparoscopic Distal Gastrectomy for Gastric Cancer

This study was designed as a randomized clinical trial comparing the totally laparoscopic distal gastrectomy with laparoscopy-assisted distal gastroectomy for patients with gastric cancer, in terms of short-term and long-term outcomes.

When one patient was enrolled, he will be randomly divided into experimental group (totally laparoscopic distal gastrectomy) or control group (laparoscopy-assisted distal gastrectomy). When he receives surgery, intraoperative parameters would be recorded. when the patient discharges, the routine follow-up would be regularly performed for the survival.

Eligibility Criteria:
Inclusion Criteria:

* aged 18-80 years old, no gender limitation;
* primary gastric cancer and planed for distal gastrectomy;

Exclusion Criteria:

* patients with total or proximal gastrectomy;
* patients with distant metastasis.
Bone Regeneration With Mesenchymal Stem Cells

Mandible fractures are a common cause of facial injury in adults. The autologous mesenchymal stem cell (AMSC) transplantation, is proposed as an alternative to the conventional graft treatment, improving bone neoformation.The objective was to evaluate the effectiveness of AMSCs application in mandibular fractures to reduce regeneration time and increase bone quality.

Single blinded controlled clinical trial in patients with mandibular angle fracture. The patients were divided into: Study Group (SG): fracture reduction plus application of AMSCs, Control Group (CG): Same procedure without AMSCs. AMSCs were obtained from adipose tissue , 24 hrs before the procedure. Intensity and density were evaluated in normal bone and fractured bone, at 4 and 12 weeks after surgery using panoramic radiography and computed tomography. (CT)

A total of 20 patients, 10 in each group were included. SG with a mean age of 31.2 ± 6.3 years and CG 29.7 ± 7.2 years, all patients were male. Bone quality at week 4 SG 108.82 ± 3.4 vs CG 93.92 ± 2.6 (p = 0.000) by panoramic radiography, SG 123 ± 4.53 vs CG 99.72 ± 5.72 (p = 0.000) by CT. At week 12: SG 153.53±1.83 vs CG 101.81±4.83 (p= 0.000) by panoramic radiography, SG 165.4 ± 4.2 vs CG 112.05±2.1 (p= 0.000) by CT.

The application of AMSCs presented at week 4 similar ossification values compared with normal bone and a 36.48 % higher ossification rate at week 12.

Eligibility Criteria:
Inclusion Criteria:

* Entitled patients to the Mexican Institute of Social Security
* Patients with mandibular condyle fractures associated or not to other initial fracture that required Open reduction and internal fixation
* Ages from 17 to 59 years
* Both female and male gender
* Patients who gave their consent to be part of this trial

Exclusion Criteria:

* Patients younger than 17 years and older than 59 years
* Chronic-degenerative diseases, active smoking, collagen disorders
* Patients with signs of infection in the aimed area to treat and in whom the fracture occurred in a longer period than 10 days before their surgery.
Diaphragmatic Exercises As Treatment of Referred Pain After Total Laparoscopic Hysterectomy: Randomized Clinical Trial.

Through a blinded clinical trial, the aim is to evaluate the efficacy of manual therapy in the treatment of pain referred to after laparoscopic hysterectomy.

Control and intervention groups were randomly established. Informed consent will be requested for participation in the study.


Eligibility Criteria:
Inclusion Criteria:

* • Patients who have given their consent to participate in the project by signing the informed consent.

  * Patient between 18 and 65 years of age.
  * Patients with a hysterectomy scheduled to be performed in less than 3 months at the Women's Hospital in Seville or at the Quirón Sagrado Corazón Clinic in Seville.
  * Who develops pain of intensity greater than 7 points located in the head, neck or upper limbs in the first 24 hours post-hysterectomy.
  * Patients who are able to communicate in Spanish or English.

Exclusion Criteria:

* Neurological Pathology.
* Non-cooperative Subject.
* Severe Psychiatric Illness.
* Loss of Cognitive Capacity.
* Evidence that post-hysterectomy pain is not caused by surgery (eg, presence of fracture or infection in the head, neck or upper limbs.
* Localized pain in areas not considered in this study and that may affect the performance and results of the study.
Aflibercept Intravitreal Injection for Myopic Choroidal Neovascularization

The purpose of this study is to evaluate the clinical results of anti-VEGF intra-vitreal injections (IVT) in CNV secondary

Twenty consecutive patients (30 eyes) with subfoveal PM-CNV, 9 of whom had been unsuccessfully treated with Visudyne PDT, were treated with IVT of 0.5mg ranibizumab. ETDRS best corrected visual acuity, macular thickness on OCT scans, and angiographic features were recorded and evaluated. The aspect of OCT scans passing across the PM-CNV was also analyzed. IVTs were repeated only in case of persistent angiographic leakage and if OCT scans showed retinal thickening or edema and serous retinal detachment. The follow-up period was at least 6 months

Eligibility Criteria:
Inclusion Criteria:

* Myopic and CNVM

Exclusion Criteria:

* Patients with poor compliance
* Patients with uncontrolled diabetes and hypertension or any other medical condition that increase the risk of complications like recent history of Stroke or myocardial infraction (\< one year). (Physician clearance was obtained for all patients).
* Age related macular degeneration with Juxtafoveal and Subfoveal CNVM: Recurrent CNVM following PDT and TTT with IVTA. Patient who could not afford PDT, Macugen or Lucentis which is FDA approved.
* Patients who had undergone major surgery 28 days before, were excluded from the study and it was also suspended prior to elective surgery.
* Refractory macular oedema due to vein occlusion, Pseudophakia, Clinically significant macular oedema (CSME) etc. that affects vision and does not respond adequately to usual treatment methods.
* Proliferative diabetic retinopathy, non-resolving vitreous haemorrhage with PDR.
* Idiopathic CNVM, Inflammatory CNVM and other conditions associated with CNVM.
Perioperative Management in Gynaecological Carcinoma Surgery

This study is to determine the effect of perioperative treatment with intravenous iron and tranexamic acid on the reduction of intraoperative and postoperative RBC transfusions in gynaecological carcinoma patients undergoing abdominal surgery.

Radical abdominal surgery often leads to intraoperative bleeding frequently exceeding 1000 ml and approximately 50% of women undergoing this surgery require blood transfusion. Perioperative blood transfusions have been shown to increase of length of stay, surgical complications, postoperative morbidity and mortality. There are a few data on the reduction in red blood cell count (RBC) transfusions using perioperative management with intravenous iron and tranexamic acid in women with gynaecological carcinoma surgery. This study is to determine the effect of perioperative treatment with intravenous iron and tranexamic acid on the reduction of intraoperative and postoperative RBC transfusions in gynaecological carcinoma patients undergoing abdominal surgery.

Eligibility Criteria:
Inclusion Criteria:

* informed consent as documented by signature
* women with gynaecological carcinoma surgery with hemoglobin level between 90-120 g/I and serum ferritin \< 100 µg/I (or ferritin index \< 3.19) at recruitment
* pregnancy test negative in women younger than 50 years

Exclusion Criteria:

* known hypersensitivity or allergy to ferric carboxymaltose or tranexamic acid
* history or present laboratory signs of bleeding disorders, coagulopathy or thromboembolic events
* history of myocardial infarction within the last year, present unstable angina or severe coronary disease
* increased plasma creatinine levels above 250 µmol/I
* inability to follow the procedures of the study (language problems, severe psychiatric or mental disorders)
* iron overload
* current administration of intravenous iron or previous intravenous iron therapy or blood transfusion within three months
* date of scheduled surgery is outside 28 days after the date of recruitment
* other clinically significant concomitant disease states (e.g., hepatic dysfunction, cardiovascular disease, etc.)
* participation in another study with investigational drug within the 30 days
* enrolment of the investigator, his/her family members, employees and other dependent persons.
Assessment of Heparin Binding Protein for the Prediction of Severe Sepsis

The purpose of this prospective, non-interventional, multi-centre clinical study is to assess the clinical validity of the Heparin Binding Protein (HBP) assay for indicating the presence, or outcome, of severe sepsis (including septic shock), over 72 hours, in patients with suspected infection following emergency department admission.

The primary objective of this study is to use HBP concentration to indicate the presence, or outcome, of severe sepsis (including septic shock) at admission and to predict the outcome of severe sepsis (including septic shock) over 72 hours, in patients with suspected infection following emergency department admission.

The secondary objectives of this study are to separately evaluate the performance of HBP concentration to a) indicate the presence of severe sepsis (including severe sepsis) at admission and b) to predict the outcome of severe sepsis (including septic shock) over 72 hours, in patients with suspected infection following emergency department admission.

Further exploratory objectives include evaluating the use of HBP measurement to indicate the outcome of severe sepsis (including septic shock) in patients with suspected infection 12-24 hours after emergency department admission, to compare the use of HBP to other markers of severe infection and to evaluate whether or not different cut-off values are required for the progression and outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age, suspected infection

Exclusion Criteria:

* None
VR for Preoperative Anxiety in Children

All of the tools currently available for preoperative preparation of children either use a third person approach (i.e., use media whereby they watch a video or look at pictures of another child receiving an anesthetic), provide tours at some time previous to the operation date, or are shown the equipment that they will encounter during their anesthetic. No preoperative programme currently allows the child to experience the entire chain of events from leaving the preoperative preparation area (and their parents), walking to the operating area, being initially prepared for and receiving anesthesia and recovering from anesthesia, in real time and from a first person perspective. As such the investigators are carrying out this study to assess whether virtual reality preoperative preparation is effective in reducing anxiety at induction of anesthesia.

The investigators' goal in this study is to investigate the effects of virtual reality preoperative preparation on anxiety in children at induction of anesthesia. The hypothesis is that utilisation of this novel 1st person immersive preparatory method will lead to an enhanced understanding of what will happen to the child (in addition to what the environment looks and sounds like) when they have their anesthetic. The investigators believe this enhanced understanding and preparation will lead to the reduction in anxiety levels before and during the induction of anesthesia, and will also lead to a reduction in postoperative negative behaviour disorders.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged between 6 -18
2. ASA physical status 1-3
3. Admitted for elective surgery (day case and inpatient cases)
4. Cognitively normal

Exclusion Criteria:

1. ASA physical status 4-5
2. Non-English speaking
3. Significant visual and auditory disorders not allowing them to use the technology
4. Epilepsy
5. Mobility problems that would make using the technology difficult or harmful to them (i.e., reduced movement of neck)
6. Cognitive impairment
7. Postoperative PICU care anticipated
Spinal Muscular Atrophy Neonatal Screening Program

Spinal muscular atrophy (SMA) is a group of disorders caused by the degeneration of the motor neuron cells of the anterior horn of the spinal cord and, in some subtypes, of the bulbar motor neurons. Almost all cases are genetically determined. Most SMAs are autosomal recessive diseases, caused by homozygous deletions of the survival motor neuron (SMN) gene located on the long arm of chromosome 5. The estimated incidence of recessive childhood and juvenile SMA linked to deletion of the SMN gene is 1 in 6000 to 10000 live births, with a carrier frequency of 1 in 35 in the general population, making it a major genetic cause of infant mortality. Up to 95-97% of all childhood cases are due to homozygous deletions of the survival motor neuron 1 (SMN1) gene, or telomeric SMN, located on chromosome 5q11.2-13.3. The remaining 3-5% of cases are due to small mutations in SMN1 (rather than complete deletions).

Until a few years ago, the prognosis of type 1 SMA was poor. In the absence of therapies, the only measures were supportive (ventilation, nutrition) and the prospect, especially in the early forms, was to accompany them towards an early end of life. There are currently three treatment options available: nusinersen, risdiplam, and gene therapy with onasemnogene abeparvovec. The three options were found to be equally effective in reducing the symptoms of the disease, making it possible to reach or safeguard fundamental stages in a child's neuromotor development, starting from the ability to remain seated. At this moment, gene therapy is probably the preferred choice. To date, in Italy, there are approximately 100 patients undergoing gene therapy.

To ensure maximum benefit for affected patients, it is essential that the therapy is administered as soon as possible. Literature shows how the administration of gene therapy in pre-symptomatic subjects made it possible to achieve a better neurological outcome compared to symptomatic patients. From this perspective, the inclusion of spinal muscular atrophy in neonatal screening is of fundamental relevance.


Eligibility Criteria:
INCLUSION CRITERIA

• Live births in the neonatologies and paediatric centers involved in the study.

EXCLUSION CRITERIA

• No consent signed by parents.
A Clinical Trial to Evaluate the Efficacy of an Oral Supplement in Supporting Vision and Eye Health

This study aims to evaluate the efficacy of BioNatureHealth's Eye Empower supplement in supporting vision and eye health. It is a virtual, single-group trial lasting 3 weeks. Participants will take three capsules of the supplement daily and complete questionnaires at Baseline, Week 1, Week 2, and Week 3 to assess visual clarity, dryness, symptoms of inflammation, and sensitivity to blue light.


Eligibility Criteria:
Inclusion Criteria:

* Male or female at birth, aged 40 or over
* Self-reported concerns about at least two of the following symptoms: dry eyes, red/itchy/irritated eyes, sensitivity to blue light, blurred vision (far or near)
* Generally healthy without uncontrolled chronic diseases
* Willing to avoid using new eye health prescriptions, over-the-counter medications, supplements, and herbal remedies for the study duration
* Consistent use of current eye health supplements or herbal remedies for at least 3 months prior to the study
* Willing to maintain current diet, sleep schedule, and activity level during the study

Exclusion Criteria:

* Pre-existing chronic conditions preventing protocol adherence, including oncological and psychiatric disorders
* Diagnosed diabetes (Type I or II)
* Planning to undergo any eye-related procedures during the study
* Recent surgeries or invasive treatments within the last six months
* History of major illness within the last three months
* Recent use of a supplement with active ingredients in the test product
* Severe allergic reactions requiring an EpiPen, including shellfish allergy
* Pregnant, breastfeeding, or planning to conceive
* Use of medications or herbal supplements that impact the blood
* Non-consumption of animal products for religious or personal reasons
* Unwillingness to follow the study protocol
* Anyone with a history of drug or alcohol abuse