cyrilzakka/clinical-trials huggingface dataset:
Prospective Study of Safety and Efficacy of InQu® Bone Graft Extender in Lumbar Interbody Fusion Surgery

The purpose of this study is to collect on-label safety and efficacy data where InQu Bone Graft Extender is applied to transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF).

It is expected that this study will contribute to the compilation of clinical data required to demonstrate the ability of InQu to promote safe, effective and timely spine fusion in patients who undergo PLIF or TLIF surgery. The results of this study will lead to further analysis (i.e. comparison to historical data of other marketed bone graft products, as well as, to local bone alone).

The purpose of this study is to collect on-label safety and efficacy data where InQu Bone Graft Extender is applied to transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF) at multiple clinical sites.

Adverse events, time to fusion and Patient Reported Outcomes(PROs) will be recorded through 12 months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* A subject may be included if s/he meets the following criteria:

  1. ≥18 years of age;
  2. Able to give appropriate informed consent;
  3. Willing and able to meet the proposed follow-up schedule;
  4. Has documented diagnosis of up to, and including, Grade 1 spondylolisthesis and/or degenerative disc disease;
  5. Has given appropriate consent for, and undergoes, standard-of-care transforminal or posterior lumber interbody fusion;
  6. Use of InQu Bone Graft Extender on-label.

Exclusion Criteria:

1. Any prior lumbar fusion surgery;
2. Requires fusion surgery of more than two adjacent levels;
3. Has fusion surgery requiring titanium cages;
4. Has a systemic infection or has infection at the site of surgery;
5. Has a medical condition or requires post-operative medication that, in the opinion of the investigator, may interfere with bony/soft tissue healing;
6. Has any physical, social, psychological or economic condition that, in the opinion of the investigator, may preclude accurate data collection or evaluation.
Evaluation of the Safety of Relaxin in Preeclampsia

The purpose of this study is to determine whether different doses of recombinant human relaxin is safe when given to women with severe preeclampsia

The effects of relaxin may be beneficial in the treatment of women with preeclampsia. This study will preliminarily evaluate the maternal, fetal and neonatal safety and tolerability of an IV infusion of relaxin compared with placebo given to women with severe preeclampsia.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of preeclampsia
* Hospital admission for expectant management

Exclusion Criteria:

* Eclampsia or history of seizures
* Vaginal bleeding
* Multifetal gestation
* Requirement for immediate delivery
Oral Corticotherapy in Megadoses to Treat Multiple Sclerosis During Relapse

This is a phase IV, multicenter, randomized, double blind clinical trial. The investigators will study 48 patients with remitting relapsing multiple sclerosis (MS) experiencing moderate or severe attack receiving immunomodulatory therapy or not. Patients will be randomly assigned to one of the two groups.

This is a multicenter, randomized, double blind clinical trial to test whether oral methylprednisolone (MP) is not inferior to intravenous methylprednisolone for the treatment of multiple sclerosis (MS) relapse in terms of clinical and radiological efficacy.

Patients will be randomly assigned to one of the following two groups.

Group A: methylprednisolone 1.000 mg/day intravenous administered during three days + placebo of methylprednisolone orally administered

Group B: methylprednisolone 1.250 mg/day orally administered during three days + placebo of methylprednisolone intravenously administered.

Clinical visits will be conducted at 7, 28 and 90 days after treatment starting.

Eligibility Criteria:
Inclusion Criteria:

1. To have been diagnosed MS Remittent Recurrent according to Mc Donald 20052 criteria.
2. To have an EDSS between 0 and 5 before the relapse.
3. The symptoms have begun after at least one month of previous stability.
4. The symptoms have started maximum 15 days before the inclusion.
5. The patient is capable of having an adequate communication with the investigator and to carry out with the clinical trial requisites.
6. To be or not to be with allowed immunomodulatory therapy (IFN-B /AG).
7. To be capable and to be willing to ingest the medication.

Exclusion Criteria:

1. First inflammatory neurological episode (relapse).
2. Multiple sclerosis secondary progressive or primary progressive.
3. The symptoms have gone on for less than 24 hours.
4. To be in treatment or have been treated with corticoids during the three months before.
5. Patients in treatment with immunosuppressors (azathioprine, mitoxantrone, ciclofosfamide...)
6. Pregnancy or breastfeeding or women in fertile age who don't use contraceptives measurements.
7. Illnesses with contraindication treatment with corticoids.
8. Antecedents of serious adverse effects or hypersensitive to related study medication.
9. Patients who wouldn´t be able to perform periodic RMN explorations, patients who are not collaborative or who need anesthesia.
10. Patients with intolerance to lactose.
11. Patients with allergy to contrast used in RMN.
12. Patients with chronic kidney disease.
13. Patients in treatment with natalizumab.
Modified Constrained - Induced Movement Therapy Compared to Intensive Bimanual Training

The purpose of the study is to evaluate the benefit of two different treatment approaches for the hemiplegic arm, modified Constraint-Induced Movement Therapy and task-related bimanual training.

Detailed description:

Constrained-Induced Movement Therapy seems to be an efficacious treatment approach for a certain subgroup of patients with moderate to mild hemiparesis after stroke. Still it remains unclear whether the training intensity or restriction of the better arm plays the bigger role. CIMT or mCIMT is usually compared to standard care of lower intensity with no constraint of the better arm, or other treatments that do not focus on functional (task-specific) training for the hemiplegic arm. Bimanual training, implying training of activities requiring use of both arms, may however, be even more effective than mCIMT, provided that the training is of similar intensity. The purposes of this study are:

1. To compare the functional effect of mCIMT to bimanual training of equal intensity in order to examine if one of the treatment approaches is superior to the other regarding the regaining of motor abilities.
2. Based on fMRI scans of a subgroup of patients, to examine whether cortical reorganization after stroke differs depending on the type of treatment received (mCIMT vs bimanual training).
3. To examine the rationale for implementing new treatment approaches in primary- and secondary health care, and thereby contribute to improved coordination between specialist and municipal health care systems.

Patients in both groups will participate in a 4 week training program, either mCIMT or bimanual. In both groups cognitive techniques will be used to increase adherence. The patients will be examined when screening, before and after the intervention, and 3 months after completed intervention.

Eligibility Criteria:
Inclusion Criteria:

* Upper extremity hemiparesis
* Between 2 and 16 weeks post-stroke
* At least 10º active extension of the wrist and at least 10º active extension of the thumb and at least 2 additional fingers

Exclusion Criteria:

* Cognitive problems, Mini Mental Status \< 24
* Excessive pain in the paretic extremity
* Major medical problems
Bio-Repository of High Risk Cohorts for the Early Detection of Pancreas Cancer

Bio-repository to collect bio-specimens from patients with 1) pancreatic cysts and 2) patients at high risk, defined by family history and/or genetic mutations, for pancreatic cancer.

Observational study to collect bio-specimens from 2 separate patient cohorts identified to be at high risk for subsequent development of pancreas cancer.

1. Patients diagnosed with a pancreatic cyst undergoing either endoscopic ultrasound or surgery. Bio-specimens collected include pancreatic cyst fluid and blood. These will be collected using a standard operating protocol.
2. Patients defined as a high risk individual for pancreas cancer by family history and/or known genetic mutations. Bio-specimens collected include blood. This will be collected using a standard operating protocol.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 with pancreas cyst
* Older than 18 at high risk for Pancreas cancer

Exclusion Criteria:

* Unable to provide consent
* Not willing to provide bio-specimens
Pelvic Fractures in the Elderly

The aim of the project is to predict the patient under conservative therapy as a function of the patient Classification of Rommens and Hofmann and other potential prognostic factors. A corresponding prognostic score may be used in the future by patients and attending physicians support joint decision between surgical and conservative treatment.


Eligibility Criteria:
Inclusion Criteria:

* Pelvic fracture after low-energy trauma
* Treatment in the years 2006 to 2016
* patients equal to or older than 60 years

Exclusion Criteria:

* Pelvic fracture after a high-energy space
* Pathological fracture in the area of a tumor or a bony metastasis
* Existence of a documented refusal
Prediction of Adverse Perinatal Outcome for Preeclampsia in Sichuan Province of China

The purpose of this study is to build a model for the prediction of adverse perinatal outcome for preeclampsia in china


Eligibility Criteria:
Inclusion Criteria:

* admitted with preeclampsia or had developed preeclampsia after admission

Exclusion Criteria:

* admitted in spontaneous labour or had achieved any component of the maternal outcome before either fulfilling eligibility criteria or collection of predictor data
Pharmacogenomics of antiVEGF in Patients With Age-Associated Macular Degeneration (AMD)

This is a phase III, multicenter, randomized double-blinded clinical trial with two parallel groups (ranibizumab and bevacizumab) and an observational follow-up of patients who meet elegibility criteria and decline participation due to treatment randomization. It will be performed involving 630 eyes from patients with wet age-related macular degeneration (wAMD) diagnosis without another eye disease. This clinical trial compares the treatment response for 3 years, considering genetic variants already studied between the eyes treated with one of the first options of anti-VEGF used in patients with wAMD, (ranibizumab) and the most cost-effective anti-VEGF (bevacizumab; off-label use)


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with neovascular Age-related Macular Degeneration
* Age of 50 years or older.
* That at the discretion of the ophthalmologist has an indication of receiving treatment with an anti-VEGF agent as usual in clinical practice.
* Without previous treatment in the eye under study (no previous treatment for AMD).

Exclusion Criteria:

* Participate or have participated in another clinical trial with an experimental drug in the last 6 months.
* Patients with other eye diseases, p. eg, advanced glaucoma or visually significant cataracts, which are likely to require surgery during the follow-up period in the eye under study.
* Concomitant, ocular or systemic, administration of drugs up to 3 months before the treatment with another anti-VEGF in the contralateral eye.
* High cardiovascular risk: poorly controlled arterial hypertension, history or risk of arterial thromboembolic events, history of stroke or acute myocardial infarction, anticoagulant treatment, proteinuria or major elective surgery within 3 months.
* Ophthalmological risk with the intraocular injection (all intravitreal treatments): active or suspected ocular or periocular infection, severe blepharitis, history of endophthalmitis, history of retinal detachment, myopathy, glaucoma.
* Hypersensitivity to the active substance or to the excipients.
* Diabetic retinopathy documented.
* Pregnant or nursing (lactating) women.

Patients who meet elegibility criteria and decline participation due to treatment randomization, will participate in an observational follow-up, collecting saliva for the analysis of genetic polymorphisms and clinical data related to antiVEGF received out of the clinical trial and AV, OCT results and adverse events registered in medical records at 6m, 12m, 24m, 36m.
Visual Impairment, Oscillopsia and Multiple Sclerosis

This study consists of two parts. The first part is a survey to examine vision-specific health-related quality of life in a cohort of patients with multiple sclerosis. We test visual impairment like visual acuity, visual field, colour discrimination, contrast sensitivity, eye movement. The aim of this part is to examine the association between responses to the quality of life scale and objective measures of visual impairment.

The second part is an open controlled study, in which we measure motion detection threshold in MS patients with oscillopsia due to pendular nystagmus and in a group of control subjects. The objective of this part is to determine whether patients with pendular nystagmus develop adaptation to oscillopsia using increased threshold of motion detection. We plan to test the effect of visuo-motor rehabilitation on this threshold in patients with oscillopsia due to pendular nystagmus.

In the first part, 100 patients with multiple sclerosis are included. A vision-specific health-related quality of life scale and neuro-ophthalmological tests are administered. The duration of intervention is about 3 hours by patient and one year to finish this part.

In the second part, we include about 40 of 100 MS patients who present an oscillopsia due to pendular nystagmus and a group of 20 control subjects. The patients and subject will perform a motion detection task and the vision-specific health-related quality of life, the intervention lasting 1 hour. Then the patients will be randomized in one group treated by rehabilitation (one 30 mn session per week during 3 months) and the other one without treatment. A motion detection task and the vision-specific health-related quality of life scale will be performed at the end of the treatment for both groups.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 90
* Patients with established multiple sclerosis
* Visual impairment recovering from MS
* Understanding rules task
* Patient can stay set a long time
* Patient's agreement
* Membership to the Social Security
* No relapsing since three months

Exclusion Criteria:

* Brain damage
* Cognitive or behaviour disorder
* Patients with peripheral vestibular, otologic or ophthalmologic pathology antecedent
* Not stabilized disease (other one than MS)
* Patient under guardianship
Effect of the Intake of Corbella Extra Virgin Olive Oil on the Microbiota-gut-brain Axis in Healthy Adults (HEVOOC)

The consumption of the improved extra virgin olive oil (EVOO) of the Corbella variety could have a beneficial effect on the microbiota-intestine-brain axis (MGBA). Olive oil contains polyphenols that are not present in other oils, notably oleocanthal and oleacein, which behave similarly to ibuprofen and have a protective effect on some neurodegenerative diseases. The polyphenols of the oil present prebiotic characteristics, at the level of the intestinal microbiota, which metabolizes them forming bioactive metabolites that can have a modulating effect on the MGBA, improving brain health. In this study, the researchers seek to identify the benefits of the consumption of Corbella variety EVOO on MGBA in healthy participants. The overall benefit of the study would be to achieve knowledge that would allow its future applicability to prevent and improve certain diseases and in general contribute to optimal health.

To evaluate possible effects on MGBA, a randomized, controlled, crossover nutritional trial will be conducted. Thirty healthy adult participants (between 18 and 35 years of age, with 50% male and 50% female) will be included according to the estimated sample size. Participants will consume a daily amount of 0.7 g Corbella EVOO/kg body weight plus their normal diet (experimental intervention) and 0.7 g refined olive oil (ROO)/kg body weight plus their normal diet (control intervention) for 1 month. Biological samples (plasma, peripheral blood mononuclear cells, serum, 24-hour urine, feces and saliva) will be obtained at baseline and at the end of each trial arm.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult with Body mass index (BMI) \< 30 kg/m2
* Signed informed consent

Exclusion Criteria:

* Any chronic disease (e.g. cardiovascular disease, cancer or diabetes)
* Mental disorders (e.g. depression, dementia, autism, etc.)
* Cardiovascular alterations in cholesterol,triglycerides, glucose, etc.
* Current smokers
* Repeated use of antibiotics
* Frequent use of corticoids, nonsteroidal anti-inflammatory drugs
* Repeated use of vitamins
* Volunteers with extreme eating habits (i.e. Atkins diet, very high protein diets, etc.)
* Excessive alcohol consumption (\>30 g/d for males and \>20 g/d for females),
* Pregnant, lactating, and postmenopausal women
Open Lung Approach During General Anaesthesia to Prevent Post-Operative Pulmonary Complications

The hypothesis of this study is that the "Open lung approach" ( recruitment and PEEP) during general anaesthesia reduces atelectasis formation and improves respiratory function in the immediate post-operative period after major abdominal surgery.

This is a prospective, randomized, controlled clinical-trial,performed in patients undergoing major abdominal surgery, to compare the effects on the post-operative pulmonary complications of two different intraoperative ventilatory strategies during general anaesthesia: 1- Control Group: PEEP 0 cmH2O without recruitment manoeuvre; 2- Treatment Group:recruitment manoeuvre (after intubation and before extubation) and PEEP 10 cmH2O In the post-operative period the following variables will be recorded at the first, third and fifth postoperative day: 1- Gas-exchange in air; 2- Chest X-ray for atelectasis evaluation; 3- signs of pulmonary complication (cough, secretions, dyspnea, thoracic pain)


Eligibility Criteria:
Inclusion Criteria:

* Patients with ASA 1, 2 and 3
* Age higher than 18 years
* Major abdominal surgery
* General anesthesia

Exclusion Criteria:

* COPD with FEV1 lower than 50%
* Ischemic cardiopathy
* Loco-regional anesthesia alone
* Minor abdominal surgery
* Laparoscopic surgery
Topiramate Treatment for Patients With Epilepsy and Learning Disability : A Prospective Observational Study

It has been estimated that 22 - 32% of people with mental retardation or learning disability have co-existing epilepsy. Despite such high prevalence and although there may be particular concerns over the effects of treatment on behaviour and cognition in this population, few studies have specifically addressed these concerns. Topiramate (TPM) is one of the modern antiepileptic drugs that has been approved for the treatment of a broad range of seizure types in both children and adults. There is evidence of associated improvement in behaviour with treatment but data is conflicting. The investigators aim to further study the effect of TPM on seizure control and behaviour using the Scales of Independent Behavior-Revised (SIB-R) which has been applied in similar patient populations and is widely adopted locally to assess the behaviour of people with mental retardation. This is a naturalistic, open label, single arm prospective study of 16-week in duration. Eligible adult patients will be initiated on TPM. Patients will be evaluated at baseline, end of weeks 4, 10 and 16. At each visit seizure control and any adverse events will be assessed. Behaviour will be assessed using SIB-R (Chinese version) at baseline and each study visit. At the end of the study period the patient's overall improvement will be rated by the investigator and the caregiver using global evaluation scales. Patients with improvement will be maintained on TPM after the end of the study period Titration schedule Topiramate will be administered orally as per usual clinical practice. Treatment will be initiated at 25 mg daily for 1 week, and increased in 25- to 50-mg increments at one- to two-weekly intervals, to an initial target dose of 100 - 200 mg daily in 2 divided doses according to each individual's response. Further dose adjustment can be made in response to further seizures or emergence of adverse events..


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or above
* Patients mental retardation and with newly diagnosed epilepsy requiring treatment, or with chronic epilepsy that is unsatisfactorily controlled (defined as at least 2 seizures during an 8-week retrospective baseline).

Exclusion Criteria:

* History of nephrolithiasis or renal impairment
* Patients with absence seizures only
* History of status epilepticus in the previous 3 months while receiving appropriate antiepileptic drug therapy
* History of suicidal attempts or psychotic illness, psychiatric or mood disorders in the previous 6 months that required hospitalisation
* History of alcohol or drug abuse in the previous year
* Patients with progressive neurological conditions or terminal medical conditions.
* Patients whose seizures are thought to be of alcoholic, metabolic, neoplastic, infectious, or non-epileptic in origin (including psychogenic seizures).
* Chronic use of antacids, calcium supplements or high dose vitamin C.
* Women who are pregnant, lactating or without adequate contraception if they have child bearing potential.
Hyaluronic Matrix Efficacy for Maxillary Sinus Augmentation

Sinus augmentation is a predictable method when alveolar bone height is not sufficient for dental implant placement in posterior maxillary alveolar region..The aim of this prospective, randomized, controlled clinical study is comparison of hyaluronic acid originated matrix and equine derived xenograft with only xenograft use in sinus augmentation by micro computed tomography and histomorphometry.


Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy patients
* Requiring bilateral maxillary sinus augmentation (residual crest height ≤ 4 mm)

Exclusion Criteria:

* Advanced systemic diseases
* Chronic medication use
* Maxillary sinus disease
* Current pregnancy
* Lactation
* Smoking habit
ATAC - Bone Density Sub-Protocol

To assess and quantify the changes in bone mineral density between the ARIMIDEX and ARIMIDEX plus NOLVADEX groups when compared to the NOLVADEX alone treatment group whilst receiving trial therapy.


Eligibility Criteria:
Inclusion Criteria:

* Eligible for entry into the main ATAC trial 1033IL/0029
* Women defined as post-menopausal
* Patients with histologically proven operable invasive breast cancer
* Who following primary surgery have a good prognosis and would be ethically suitable to remain untreated

Exclusion Criteria:

* Excluded from entry into the main ATAC trial (1033IL/0029)
* Patients who have received hormone replacement therapy within the previous 12 months prior to randomisation
* Patients who have received bisphosphonate therapy within the previous 12 months prior to randomisation
* Patients who have had a bone fracture within the previous 6 months prior to randomisation