cyrilzakka/clinical-trials huggingface dataset:
Treatment of Chronic Subdural Hematoma by Corticosteroids

Chronic subdural hematomas are a frequent neurosurgical pathology in the elderly. Gold standard is surgical evacuation of these hematomas. Physiopathology of chronic subdural hematoma involves numerous inflammatory processes which could be inhibited by steroids.

The primary objective is to evaluate the efficacy of corticosteroids treatment in patients with Chronic subdural hematomas without clinical or radiological signs of severity.

Secondary objectives are to assess the effect of methylprednisolone on:

* quality of life evolution,
* morbidity and mortality,
* radiological evolution of the lesions.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years old,
* With chronic or subacute, uni or bilateral subdural hematoma,
* Confirmed by cerebral scan without contrast enhancement,
* Without clinical and radiological signs of severity,
* Written informed consent from patients or their next of kin according to the patients cognitive status.

Exclusion Criteria:

* Diabetics patients,
* Contraindication for methylprednisolone,
* Previous surgery for chronic subdural hematoma during the past 6 months,
* Pre-existing severe dementia related to other etiology than the Chronic subdural hematomas,
* Existing neurological pathology that can be associated with dementia,
* Patients treated with corticosteroids,
* Protected person (adults legally protected (under judicial protection, guardianship or supervision), person deprived of their liberty, pregnant woman, lactating woman and minor),
* Participating in other concomitant research.
Study Comparing Cyclosporine With Infliximab in Steroid-refractory Severe Attacks of Ulcerative Colitis

PHASE: IV

TYPE OF STUDY: With direct benefit.

DESCRIPTIVE: Multicenter, randomized, open label study.

INCLUSION CRITERIA: Steroid-refractory ulcerative colitis.

OBJECTIVES: To compare the efficacy of cyclosporine with infliximab in steroid- refractory attacks of ulcerative colitis.

STUDY TREATMENTS:Cyclosporine 2mg/kg/day intravenous(IV)for 7days then Neoral 4mg/kg/day orally for 3 months. Infliximab 5mg/kg at Weeks 0, 2 and 6.

NUMBER OF PATIENTS: 50 patients in each group i.e. a total of 100 patients.

INCLUSION PERIOD: 24 months.

STUDY DURATION: 27 months.

MAIN EVALUATION CRITERIA:

Clinical response at D7 according to the Lichtiger Index score AND Clinical Remission at D98 according to the Mayo Disease Activity Index score

SECONDARY EVALUATION CRITERIA:

Clinical remission at D98 (according to the Mayo Disease Activity Index score) Endoscopic response Colectomy rate Tolerance


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* Diagnosis of UC according to Lennard-Jones criteria (Appendix 1).
* Endoscopically demonstrated colorectal lesions localized above the anal margin and extending at least up to 15cm proximally.
* Severe acute flare of UC with a Lichtiger Index score \> 10.
* Refractoriness to high dose intravenous steroid therapy (≥ 0.8 mg/kg/d of methylprednisolone or equivalent) given for at least 5 days.
* Adequate contraception for male or female subjects of childbearing potential, which will be continued throughout the study and at least 3 months after study termination.

Exclusion Criteria:

* Pregnant or breast-feeding woman.
* Previous treatment with cyclosporine or infliximab.
* Azathioprine or 6-mercaptopurine treatment initiated more than 4 weeks before inclusion.
* Indication for immediate surgery.
* History of colorectal dysplasia.
* Diagnosis of Crohn's disease.
* Positive stool tests for amoebiasis and/or positive bacteriological culture for Salmonella, Shigella, Yersinia and Campylobacter and/or presence of Clostridium difficile B toxin in the stools.
* Renal failure (creatininemia \> upper limit of normal laboratory value).
* Uncontrolled high blood pressure.
* HIV, HBV viral infection (except the presence of positive anti-HBs antibodies) with serology not older than 3 months.
* Uncontrolled bacterial or active viral infection.
* Past medical history of malignant condition in the last 5 years (including leukaemia, lymphoma and myelodysplasia) except for baso-cellular cutaneous cancers.
* Past medical history of myocardial infarction or heart failure.
* Intradermal reaction to Tuberculin (Tubertest® 5 units) \> 5mm.
* Active tuberculosis
* Untreated latent tuberculosis (see national recommendations. Appendix 2).
* Abnormal blood count with polynuclear neutrophils \< 1,500 G/L or white cells \< 3,000, or platelets \< 100,000 G/L.
* Unexplained rise higher than 3 times the normal level for transaminases, alkaline phosphatases and/or higher than twice the normal level for bilirubin.
* Non-compliant subjects.
* Participation in another therapeutic study.
Analysis of the Aetiological Factors of Malnutrition

Disease-related malnutrition (DRM) is a frequent syndrome in clinical practice, in which the mutual relationship between disease and malnutrition is observed. Inflammation, anorexia, changes in body composition or in energy and protein requirements, contribute to the development of DRM. The Global Leadership Initiative on Malnutrition (GLIM criteria) provides a diagnostic system of malnutrition that has been accepted by the main international scientific societies in the field of clinical nutrition.

The GLIM criteria proposes an algorithm that includes phenotypic criteria (weight loss, underweight and low muscle mass), with their corresponding severity thresholds, and aetiological criteria (decreased oral intake, nutrient malabsorption and the presence of an inflammatory component). The diagnosis of malnutrition is established when an aetiological and a phenotypic criterion are met.

The aim of the study is to determine the diagnostic and prognostic value of aetiological factors of malnutrition based on GLIM criteria, presence and degree of inflammation and dietary intake, in patients diagnosed with DRM.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of DRM based on GLIM criteria with the presence of the aetiological criterion of inflammatory component and candidate for medical nutritional treatment according to current regulations.
* Agreeing to voluntarily participate in the study and sign the informed consent form, after having read the participant information sheet.
* Presence of an inflammatory response (CRP\>3 mg/dl)
* Having an adequate cultural level and understanding of the clinical study.

Exclusion Criteria:

* Pregnant or breastfeeding women
* Patients with advanced liver cirrhosis or chronic hepatitis (Child=C scale)
* Patients with advanced neoplastic disease with life expectancy \<6 months
* Patients with renal insufficiency with creatinine clearance less than 45 ml/min
* Severe infection in the last 3 weeks
* Taking antibiotic therapy at the time of inclusion, with the exception of prophylactic treatments
* Taking corticosteroids at the current time or one month prior to inclusion
* Treatment with biological therapies (antibodies) at the current time or one month in advance
* Taking non-steroidal anti-inflammatory drugs at the time of inclusion
* Taking omega 3 supplements for any concomitant pathology at the time of inclusion
* Undergoing surgery during the follow-up phase of the study
* Initiation of any drug during the study phase that may modify the patient's inflammatory pattern at the investigator's discretion
* Any criterion that, in the opinion of the principal investigator, could condition the conduct of the study.
Finnish Trial on Practices of Anterior Cervical Decompression (FACADE) Comparing Outpatient vs. Inpatient Care

FACADE is a prospective, randomized, controlled, parallel group non-inferiority trial comparing the traditional hospital surveillance (inpatient, patients staying in the hospital for 1-3 nights after surgery) to outpatient care (discharge on the day of the surgery, usually within 6-8 hours after procedure) in patients who have undergone anterior cervical decompression and fusion (ACDF) procedure.

To determine whether early discharge (outpatient care) is noninferior to inpatient care, the investigators will randomize 104 patients to these two groups and follow them for 6 months using the Neck Disability Index (NDI) as the primary outcome. The investigators expect that early discharge is not significantly worse (inferior) than the current care in terms of change in NDI. Noninferiority will be declared if the mean improvement for outpatient care is no worse than the mean improvement for inpatient care, within statistical variability, by a margin of 17.3%. The investigators hypothesize that a shorter hospital stay results in more rapid return to normal daily activities, shorter duration of sick leave and decreased secondary costs to health care system. Secondary outcomes in the study are arm pain and neck pain using the Numeric Rating Scale, operative success (Odom's criteria), patient's satisfaction to treatment, general quality of life (EQ-5D-5L), work ability score (WAS), sickness absence days, return to previous leisure activities, and complications.

Patients who are eligible for the trial, but are not willing to undergo randomization, will be asked to be included in a simultaneous, pragmatic follow-up cohort.

Eligibility Criteria:
Inclusion Criteria:

1. Cervical radiculopathy syndrome (CRS) unresponsive to non-operative treatment for at least six weeks or with severe progressive signs and symptoms of nerve root compression during conservative treatment of shorter duration.
2. CRS is defined as pain, paresis or paresthesia in corresponding nerve root distribution areas of C5, C6, C7 or C8.
3. Nerve root stenosis determined by magnetic resonance imaging at treatment level correlating to CRS/symptoms
4. Neck Disability Index score ≥30 out of 100
5. Age between 18 to 62 years
6. No previous cervical operations
7. Currently employed
8. No co-morbidities causing a need for a sick leave
9. Provision of informed consent from the participant
10. No contraindication for randomization in postoperative check (see below)

Exclusion Criteria:

1. MRI finding inconsistent with patient's symptoms
2. Diagnosed osteoporosis or permanent use of oral corticosteroids
3. ACDF operation requiring plate or cage fixation with screws
4. Active malignancy
5. American Society of Anesthesiologists Physical Status Classification system (ASA) 4 and 5 patients (seriously ill patients)
6. Pregnancy
7. Abundant use of alcohol, drugs or narcotics
8. No possibility to be accompanied by an adult person over the first postoperative night after the surgery
9. Insufficient Finnish language skills
10. Distance to the closest hospital emergency more than 60 min
Management of Peyronie's Disease With Adipose Tissue Stem Cell

Erectile dysfunction is growing in prevalence all over the world and one of the most existing disease in old age patients There is many lines of treatment concerning the status of patient like psychosexual, medical, and surgical treatment But Pyronie's disease is common now among people especially diabetics, and the role of treatment still controversial in results We can start conservative treatment and then surgical treatment if fail but the outcome still not convinced Many patients refuse to fix penile prosthesis and to make operation like nesbite for probability of shortening of penis We start to use stem cell in patients have erectile dysfunction and Peyronie's disease The injection of stem cell will be at corpora cavernosa and intra dorsal penile artery under Doppler device guidance

Peyronie's disease associated with erectile dysfunction nan be treated by different methods We start to treat such patients with adipose tissue stem cell Harvesting stem cell from adipose tissue and injected into corpora cavernosa and penile artery and we assess quality of erection through patient history and penile duplex and also assess plaque size and other symptoms related to Peyronie's disease

Eligibility Criteria:
Inclusion Criteria:

* erectile dysfunction associated with Peyroni's diseas

Exclusion Criteria:

* nil
DWI MR-enterography Without or With Bowel Cleansing to Assess Intestinal Inflammatory Activity in the Follow-up of Crohn's Disease

Since 2009, many studies tend to prove the effectiveness of diffusion-weighted MR-enterography in the assessment of inflammatory activity in IBD compared to standard MR-enterography, with the emergence of new radiological scores such as the Clermont score. Diffusion-weighted MRI (DWI) is a faster technique and does not require the injection of gadoline contrast medium, which is a desirable in view of recent data on their long-term adverse effects (intracerebral deposits, nephrogenic systemic fibrosis).

The advent of 3T MRI, which provides a better signal, a better spatial resolution or the same examination quality in a shorter time, seems promising for the future of DWI.

However, to date, there are still few studies carried out at 3T in this field or even few studies on the possibility of doing away with bowel cleansing, although this is one of the main demands of patients. All patients will undergo a simplified MR-enterography, which includes four sequences, without bowel cleansing or injection. On the same day, the standard MR-enterography will be performed as in clinical practice, after ingestion of the usual oral preparation.

Three reading sessions of the examination will be organized at intervals of at least one month by two radiologists specialized in digestive imaging, blinded to the clinical and


Eligibility Criteria:
Inclusion Criteria:

* Any patient diagnosed with Crohn's disease with bowel involvement for whom a MR-enterography was ordered as part of their follow-up
* Age ≥ 18
* Subject's ability to understand and express opposition
* Affiliation to French social security system

Exclusion Criteria:

* Any contraindication to MRI
* Allergy to gadolinium chelates
* Claustrophobia
* Major obesity that does not allow the patient to enter the machine's tunnel (whose diameter is 70 cm)
* Pregnant woman
* Person under curators or guardianship
Study of Mechanisms of Anovulation in Polycystic Ovary Syndrome

We previously hypothesized that the excess of Anti-Mullerian Hormone (AMH) at the level of ovarian selectable follicles could be involved in the follicular arrest of Polycystic Ovary Syndrome (PCOS), mainly through inhibition of FSH effect on aromatase expression.In this study, we plan to investigate whether a drop in the serum AMH level would be concomitant to the appearance of a dominant follicle induced by administration of mild amounts of exogenous FSH in women with PCOS.

Women with PCOS (Rotterdam definition) whom anovulation is resistant to clomiphene citrate will receive recombinant FSH using the low-dose step-up protocol during only one cycle. Serum levels of estradiol, AMH, LH, FSH, inhibin B and ultrasound (U/S) parameters will be assessed twice a week until 3 days after appearance of \> 1 dominant follicle(s).The starting dose of recFSH will be 50 IU/day. In the absence of criteria for dominance (see below) after 14 days at 50 IU/day, recFSH dose will be increased by 25 IU/day every 7 days until dominance is achieved. Dominance will be defined by the appearance of at least one follicle \>10 mm growing at least 2 mm/day and serum E2\> 100 pg/L. Ultrsound examination will performed with a 7-MHz transvaginal transducer (Sonoline Elegra, Siemens), in real time, according to a standardized protocol.Serum AMH levels will be assessed using the second-generation enzyme immunoassay AMH-EIA.

Eligibility Criteria:
Inclusion Criteria:

* normal sperm analysis in the partners and normal hysterosalpingography in all patients
* PCOS defined by Rotterdam criteria
* resistance to clomiphene citrate, i.e. no ovulation at 150 mg/day or no pregnancy after 6 ovulatory cycles
* informed consent before inclusion

Exclusion Criteria:

* on-going pregnancy
* age\<18 or \>40 yr.
* unability to understand the treatment protocol
* other medications
* any co-existent morbid condition contra-indicating a pregnancy
rhBMP-2/CRM/CD HORIZON® Spinal System Pivotal Study

The purpose of this study was to evaluate the rhBMP-2/CRM/CD HORIZON® Spinal System as a method of facilitating spinal fusion in patients with degenerative disc disease.

This clinical trial was conducted to evaluate the rhBMP-2/CRM/CD HORIZON® Spinal System for posterolateral fusion treatment of patients with symptomatic degenerative disc disease versus the control group of autogenous bone with the CD HORIZON® Spinal System.

The investigational treatment was the open bilateral posterolateral implantation of the rhBMP-2/CRM/CD HORIZON® Spinal System. One investigational implant was placed across two adjacent transverse processes on each side of the spine during the spinal fusion procedure.

The control treatment was the bilateral posterolateral implantation of the autogenous bone harvested from the iliac crest with the CD HORIZON® Spinal System.

Eligibility Criteria:
Inclusion Criteria:

Each patient participating in this clinical trial must meet all of the following inclusion criteria:

1. Has degenerative disc disease as noted by back pain of discogenic origin, with or without leg pain, with degeneration of the disc confirmed by patient history of pain and radiographic studies:
2. Requires fusion of a single level disc space from L1 to S1.
3. Has not responded to non-operative treatment (e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS) for a period of 6 months.
4. If of child-bearing potential, patient is non-pregnant, non-nursing, and agrees to use adequate contraception for 1 year following surgery.

Exclusion Criteria:

A patient meeting any of the following criteria is to be excluded from this clinical trial:

1. Has primary diagnosis of a spinal disorder other than degenerative disc disease with Grade 1 or less spondylolisthesis at the involved level.
2. Had previous spinal fusion surgical procedure at the involved level.
3. Requires spinal fusion at more than one lumbar level.
4. Has been previously diagnosed with osteopenia.
5. Has presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).
6. Has a history of autoimmune disease (e.g. Systemic Lupus Erythematosus or dermatomyositis).
7. Has a history of exposure to injectable collagen or silicone implants.
8. Has received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following rhBMP 2/CRM implantation.
9. Has received any previous exposure to any/all BMP's of either human or animal extraction.
Postoperative Stress Response in Patients Following Fast Track vs Conventional Protocol After Hepatectomy or Pancreatectomy

A prospective randomized clinical study, with cross-sectional comparisons and correlations was conducted from May 2012 to July 2015 with a sample of 231 patients who have undergone hepatectomy or pancreatectomy, randomized into 2 groups. In group A was applied postoperatively the protocol Fast-track, while in group B the conventional postoperative care. Demographic and clinical data were collected. In 170 patients, Neuropeptide Y (NPY), Adrenocorticotropic hormone (ACTH)/Cortisol plasma levels were measured by ELISA method: a) at the day of patient's admission, b) the operation day, c) the 3rd postoperative day or prior to discharge.

Pain levels were assessed by Puntillo scale (behavioral observation scale) which has ranges; 0-1 "no pain", 2-4 "aching" 5-7 "moderate pain" 8-10 and "severe pain".

Patient stress levels were evaluated by: a) scale I.C.U.E.S.S. which evaluated environmental stress during their stay in hospital and takes values; 40-80 "no environmental stress" 81-120 "mild to moderate environmental stress," 121-160 " Moderate to severe environmental stress ", b) three questions of self- experienced feelings (with a score of 0 = None and 10 = Completely) like "How sad you feel right now?" "How stress do you feel right now?" "How optimist do you feel right now about the future?" The data collected in three phases: a) the day of hospitalization, b) the day of surgery, and c) the third postoperative day or before discharge.

Depression levels were evaluated with Zung scale (Zung self-rating depression scale), which assesses depression levels with a score 25-49 for "normal level mood," 50-59 for "mild depression", 60-69 for "moderate depression" and 70 + for "severe depression".

Eligibility Criteria:
Inclusion Criteria:

* patients with American Society of Anesthesiologists (ASA) PHYSICAL STATUS CLASSIFICATION SYSTEM I-III
* age 30-82 years,
* with normal level of consciousness and communication

Exclusion Criteria:

* the presence of chronic pain,
* kidney disease, neuropathy,
* systemic as well as chronic treatment with analgesics
Early Versus Interval Appendectomy for Ruptured Appendicitis in Children

The purpose of this randomized trial is to compare two commonly utilized surgical treatments for children with ruptured appendicitis: early appendectomy, versus interval appendectomy. The primary outcome measure is time away from normal activities.

There are two surgical treatment options for children with ruptured appendicitis. Early appendectomy is one option and typically involves removing the ruptured appendix after several hours of optimizing the patient medically with intravenous fluids and intravenous antibiotics. Another option, interval appendectomy, uses the same initial fluid and antibiotic management, but delays removing the appendix until 6-8 weeks later. The rationale for delaying the appendectomy is to perform the operation at a time when the patient is perhaps more stable and the abdominal cavity is free from contamination. Both of these treatment options are currently used by many pediatric surgeons across the United States and both appear to work well. The two treatment have never been compared in any prospective study. The primary outcome of the study is the time that a patient (and family) is away from normal activities, due to the disease and its treatment. Secondary outcome measures include complication rates, quality of life measures (SF10), hospital cost analysis, and others.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of ruptured appendicitis

Exclusion Criteria:

* Inability to have usual follow up care (e.g. transient to area)
Double Balloon Catheter Versus Dinoprostone Vaginal Insert for Cervical Ripening.

To compare the efficacy of transcervical double balloon catheters versus controlled release dinoprostone vaginal inserts for pre-induction cervical ripening in term women with unfavourable cervices.


Eligibility Criteria:
Inclusion Criteria:

* singleton gestation
* gestational age greater than 34 weeks
* cephalic presentation
* intact membranes
* Bishop score of ≤4
* reactive fetal heart rate (FHR) pattern on admission

Exclusion Criteria:

* any condition precluding vaginal delivery
* any contraindication to receiving prostaglandins, including history of asthma, glaucoma, or cardiac or cardiovascular disease
* previous cesarean section or other uterine incision