cyrilzakka/clinical-trials huggingface dataset:
Multicenter, Uncontrolled Pilot Study Evaluating the Efficacy of Eculizumab in the Treatment of Gemcitabine-induced Thrombotic Microangiopathies

The main objective of this prospective multisite trial is to study the evolution of TMA (thrombotic microangiopathy) induced by gemcitabin and treated by eculizumab.


Eligibility Criteria:
Inclusion Criteria:

* 1. Age ≥ 18 years old 2. Previous treatment with gemcitabine within the last 18 months (duration of treatment ≥ 3 consecutive months and cumulative dose should be ≥ 10 grams). 3. Neoplasia in remission or not in remission but with an estimated life expectancy \> 6 months 4. Acute renal failure defined by 1 of the following 2 criteria : Creatinine \> 2 times baseline creatinine and/or diuresis \< 0.5 ml/kg/h for 12 hours. 5. Clinical and biological criteria for thrombotic microangiopathy: mechanical hemolytic anemia and/or tThrombocytopeniaPatient affiliated with a social security system, 6. Adult patient or representative of the adult patient who has read and understood the information letter and signed the consent form. 7. Woman of childbearing age with effective contraception as defined by the WHO (estrogen-progestin or intrauterine device or tubal ligation) for more than one month and a negative -HCG pregnancy test at baseline, for the duration of the study and for at least 5 months after the end of the treatment, or Postmenopausal woman (non-medically induced amenorrhea for at least 12 months prior to the baseline visit) or For men, use of protection during sexual intercourse for the duration of the study and for at least 60 days after the end of study treatment

Exclusion Criteria:

* 1. Progressive neoplasia with a life expectancy of \<6 months 2. Patient with a contraindication to the administration of the treatment experienced: SOLIRIS® 300 mg concentrate for solution for infusion 3. Contraindication to antibiotic prophylaxis 4. Thrombotic microangiopathy associated with cancer (metastatic adenocarcinoma with bone marrow invasion, erythromyelemia, disseminated intravascular coagulation) 5. Active systemic bacterial infection, untreated or confirmed sepsis (positive blood cultures within 7 days of patient inclusion and not treated with effective antibiotic therapy) 6. Unresolved meningococcal infection 7. Patient not vaccinated against meningococcal infection 8. Pregnant or breastfeeding woman or proven lack of contraception 9. Known systemic lupus erythematosus 10. Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection, under guardianship or curatorship 11. Patient participating in another interventional clinical trial / having participated in another interventional clinical trial within 1 month
Physical Therapy Treatments, Including Neural Mobilization and Hip/Back Stretches for People Between 50-89 With Lumbar Spinal Stenosis and Leg Pain Provoked by Walking

Aging of the back is common in the older people and can result in difficulties standing and walking. Conservative treatment is recommended before considering surgery. Some recommended exercises involve the use of expensive equipment. The present study plans to evaluate if specifically moving the nerves in the legs/back and improving flexibility of the hip and back can benefit patients. These exercises require no equipment, are simple to perform, and can provide patients a way to continue to perform these exercises at home. The purposes of this study are to (1) observe the benefit of a treatment program involving moving the nerves of the leg/back, stretching the legs and low back in patients with low back pain and difficulties walking; and (2) determine if benefits received remain at a 3-month follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged between 50-89 years old
* Intermittent unilateral or bilateral leg pain occurring with walking and standing activities that is relieved only with sitting or by assuming flexed positions
* Magnetic Resonance Imaging (MRI) confirmation of lumbar spinal stenosis
* Leg symptoms greater than 4/10 and provoked within 15 minutes of walking

Exclusion Criteria:

* Prior lumbar surgery
* Spinal injection in last 6 weeks
* Impaired walking tolerance due to factors other than neurogenic claudication
* Inability to follow the rater's instructions
* Any medical contra-indication for hip mobilizations in extension or flexion
* Current medico-legal issues
Comparing Manual Versus Stapled Side to Side Ileocolic Anastomosis in Crohn's Disease

RESEARCH QUESTION Are handsewn (end to end and Kono S side to side) anastomoses superior to side to side stapled anastomosis after ileocolic resection for Crohn's disease with respect to endoscopic recurrence, gastrointestinal function and costs.

HYPOTHESIS Stapled side anastomosis advised in ECCO guidelines heal with ulcerations on the staple line causing systematic over scoring of endoscopic recurrence leading to unjustified restarting of expensive drugs reducing QOL and increasing costs. Side to side saccular configuration causes stasis affecting recurrence and dysfunction.

DESIGN Randomised superiority study

POPULATION Patients with Crohn requiring (re)resection of the (neo)terminal ileum

INTERVENTION Kono S and end to end hand sewn anastomosis

USUAL CARE Side to side stapled anastomosis

OUTCOME Endoscopic recurrence (local and central reading) at 6 months

SAMPLE 25% reduction in 2:1 ratio -\> 126 + 63 = 189 patients

KEYWORDS Crohn, ileocolic resection, recurrence


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged \>18 years
* Ileocolic disease or disease of the neoterminal ileum with an indication for resection
* Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, and anti-TNF therapy are permitted.
* All patients should have undergone a colonoscopy and MR enterography (or CT enterography if MR contraindicated) in last 3 months to assess extent of disease.
* Ability to comply with protocol.
* Competent and able to provide written informed consent.
* Patient must have been discussed in the local MDT

Exclusion Criteria:

* Inability to give informed consent.
* Patients less than 16 years of age.
* Patients undergoing repeated ileocolic resection.
* History of cancer \< 5 years which might influence patients prognosis
* Emergent operation. Pregnant or breast feeding.
The Different Design of Orthokeratology

In this study, we intend to enroll orthokeratology subjects aged 8-18 years old with binocular myopia up to and including -4.00 D. They were randomly selected to wear both orthokeratology of different designs, one with an aspheric wide inversion zone design in the optical zone and the other with a traditional spherical curved segment design, and to investigate the differences between these two lenses in terms of their effectiveness in myopia retardation, defocus, and aberration.


Eligibility Criteria:
Inclusion Criteria:

* The age is greater than 8 years and less than 18 years
* The myopia was within -4.00D (including -4.00D), and the astigmatism was within 1.50D (including 1.50D) in both eyes.
* Be able to complete 12 months of follow-up
* They were able to understand the purpose of the trial, volunteered to participate, and signed informed consent by the subjects themselves or their legal guardians

Exclusion Criteria:

* One eye met the inclusion criteria
* Patients with systemic diseases causing immunocompromised or affecting orthokeratology
* There are other eye diseases that affect orthokeratology lens wearing, such as dacryocystitis, blepharitis, various inflammation, glaucoma, etc
* Abnormal cornea
* Previous corneal surgery or corneal trauma history
* Active keratitis (e.g., corneal infection)
* Patients with best corrected distance visual acuity of less than 5.0
* Patients with corneal flat curvature lower than 39.00D, or higher than 48.00D
* Patients with refractive instability
* Patients with overt strabismus
* The corneal epithelium showed obvious fluorescent staining, which was not suitable for patients wearing orthokeratology lenses
* Patients with dry eye are not suitable for orthokeratology
* Patients with corneal endothelial cell density less than 2000 cells /mm2
* Patients who had worn rigid contact lenses (including orthokeratology lenses) within the previous 30 days
Effectiveness of Different Hypopressive Exercises in Pelvic Floor Dysfunction

The purpose of the study is to compare the efficacy of different modalities of hypopressive exercises and biofeedback with ultrasound in women with pelvic floor dysfunctions, considering the efficacy of the treatment as improving the specific quality of life related to pelvic floor dysfunctions and improvement of the muscular properties of the pelvic floor muscles.

Female 18-65 years old

Inclusion Criteria:

Women diagnosed with pelvic floor dysfunction by their doctor. With minimum strength of the pelvic floor muscles of 3 according to Modified Oxford Score

Exclusion Criteria:

Women who are pregnant or women who have had a vaginal or caesarean birth in the past six months.

Women whose PFD is severe and the first indication is surgical (POP-Q grade III-IV prolapses).

Women with only urinary incontinence or fecal urgency. Women with pain in the pelvic-perineal region of 3 cm in the visual analog scale, where a score of 0 cm means no pain, and a score of 10cm, the maximum pain that the participant can imagine.

Women who have received pelvic floor physiotherapy treatment in the last 12 months.

Women who are unable to voluntarily contract the pelvic floor muscles, quantified by the Modified Oxford Score by a score less than or equal to 2.

Women with any pathology that may affect the treatment (neurological, gynecological or urological), or with recurrent urinary infection or hematuria.

Women with cognitive limitations to understand the information, answer the questionnaires, consent and / or participate in the study.

Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with pelvic floor dysfunction by their doctor.
* With minimum strength of the pelvic floor muscles of 3 according to Modified Oxford Score

Exclusion Criteria:

* Women who are pregnant or women who have had a vaginal or caesarean birth in the past six months.
* Women whose PFD is severe and the first indication is surgical (POP-Q grade III-IV prolapses).
* Women with only urinary incontinence or fecal urgency.
* Women with pain in the pelvic-perineal region of 3 cm in the visual analog scale, where a score of 0 cm means no pain, and a score of 10cm, the maximum pain that the participant can imagine.
* Women who have received pelvic floor physiotherapy treatment in the last 12 months.
* Women who are unable to voluntarily contract the pelvic floor muscles, quantified by the Modified Oxford Score by a score less than or equal to 2.
* Women with any pathology that may affect the treatment (neurological, gynecological or urological), or with recurrent urinary infection or hematuria.
* Women with cognitive limitations to understand the information, answer the questionnaires, consent and / or participate in the study.
Protein Expression in Tumor Tissue Samples From Patients With Cancer of the Oropharynx

RATIONALE: Studying the proteins expressed in samples of tumor tissue from patients with cancer may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors plan better treatment for patients with cancer of the oropharynx.

PURPOSE: This laboratory study is looking at protein expression in tumor tissue samples from patients with cancer of the oropharynx.

OBJECTIVES:

* To investigate if some of the differences in gene expression are also reflected at the protein level.
* To determine whether differences in gene expression that are also reflected at the protein level can be used to develop markers for early detection and disease surveillance.
* To identify targets for therapy.

OUTLINE: Archived tumor tissue samples are analyzed for expression of standard immunohistological markers (e.g., p16, p53, and Ki-67) as well as expression of genes identified in a previous gene expression study. Protein expression data are tested for clinical and demographic correlates and compared with gene expression data.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of squamous cell carcinoma of the oropharynx
* Tumor tissue samples available from Vanderbilt Head and Neck Tumor Repository and Vanderbilt Pathology archives

Exclusion Criteria:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Cod Liver Oil for Covid-19 Prevention Study

A randomized, parallel-group treatment, quadruple masked, two-arm study to assess the effectiveness of cod liver oil compared to placebo in the prevention of Covid-19 and airway infections in healthy adults.

In this study, the investigators will investigate whether daily cod liver oil can prevent Covid-19 infections and reduce the severity of such infections. The investigators will also examine whether cod liver oil prevents other airway infections in healthy adults.

Preliminary evidence from literature and an ongoing study in the investigators' lab suggests that cod liver oil may prevent Covid-19 and complications of Covid-19. In the present study, the investigators will examine whether this is actually the case by randomizing volunteers to take cod liver oil or placebo (corn oil) during the winter months of 2020-2021. The investigators also aim to explore whether cod liver oil can prevent other respiratory tract infections, as well as explore and confirm already known health effects and possible new health effects, in particular rare adverse events associated with cod liver oil use.

Cod liver oil is a traditional source of vitamin A, D, and E and omega-3 fatty acids and the dose administered in the study will contain 250 ug vitamin A, 10 ug vitamin D, 10 mg vitamin E, and 1,2 g omega-3 fatty acids.

Eligibility Criteria:
Inclusion Criteria:

* Any person \>18 years with a Norwegian Personal Identity Number

Exclusion Criteria:

* History of renal failure or dialysis, hypercalcemia, severe liver disease (cirrhosis), sarcoidosis or other granulomatous diseases (Wegener)
* Allergy to fish or corn oil.
* Pregnancy or planned pregnancy before summer 2021
* Vegan diet
* Age \>75 years old at inclusion based on the Norwegian Personal Identity Number
* Difficulty in swallowing cod liver oil or other oils
* Previous Covid-19 disease
* For Caucasians only: Use of any supplement containing more than trace amounts of vitamin D or omega-3 fatty acids at inclusion (Vitamin D levels in non-Caucasians living in Norway are frequently low even among those self-reporting using dietary supplements). This criterion will be relaxed if too few participants volunteer for the study and only Caucasians that use cod liver oil or an equivalent dietary supplement (with omega 3 and vitamin D) more than 5-7 times per week will be excluded.
Bioburden Reduction of Diabetic Foot Ulcer

Study to see if a laser can get rid of bacateria called MRSA in your diabetic ulcer


Eligibility Criteria:
Inclusion Criteria:

* 18 and older
* Diabetic foot ulcer
* MRSA positive

Exclusion Criteria:osteomylelitis pregnancy allery to e mycin

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A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Hepatitis Be Antigen (HBeAg) Positive Chronic Hepatitis B (CHB).

This 4 arm study will compare the efficacy and safety of PEGASYS given for 24 or 48 weeks, and at doses of 90 or 180 micrograms weekly, in the treatment of HBeAg positive patients with chronic hepatitis B. Patients will be randomized to one of 4 treatment groups: a)PEGASYS 90 micrograms subcutaneous (sc) weekly for 24 weeks, b)PEGASYS 180 micrograms sc weekly for 24 weeks, c)PEGASYS 90 micrograms sc weekly for 48 weeks or d)PEGASYS 180 micrograms sc weekly for 48 weeks. Following treatment there will be a 24 week period of treatment-free follow-up in all treatment groups for the primary endpoint. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* positive Hepatitis B surface antigen (HBsAg) for \>6 months, positive HBeAg, HBV DNA \>500,000 copies/mL, and anti-HBs negative;
* liver disease consistent with Chronic Hepatitis B.

Exclusion Criteria:

* antiviral therapy for CHB within previous 6 months;
* co-infection with Hepatitis A virus (HAV), Hepatitis C virus (HCV), Hepatitis D virus (HDV) or Human immuno deficiency virus (HIV);
* evidence of decompensated liver disease;
* medical condition associated with chronic liver disease.
A Study That Will Look at the Impact of Immunosuppression on Antibody Production in Kidney Transplant Recipients.

This study is being done to collect blood and bone marrow samples for biologic studies of antibody producing cells. Donor specific antibodies can cause damage to the kidneys after they are transplanted. The study will look at the impact of immunosuppression on antibody production by antibody producing cells.

Bone marrow and blood samples from both non-sensitized kidney transplant recipients and sensitized kidney transplant recipients will be collected. The samples will be used to compare the effect immunosuppression has on the antibody producing cells from both of these kinds of transplant recipients. Bone marrow will be collected from sensitized kidney transplant recipients before desensitization therapy prior to transplantation and at the time of kidney transplant surgery. Non-sensitized patients will have bone marrow collected only at the time of kidney transplant surgery. Blood will be collected at the same time point that the marrow is collected in both kinds of patients.

Eligibility Criteria:
Participants must be between the ages of 18 and 70 years of age and undergoing a kidney transplant.
The Relationship Between Lower Extremity Selective Motor Control and Gait in Children With Cerebral Palsy

The aim of this study is to examine the relationship between lower extremity selectivity and gait in children with cerebral palsy. 32 volunteer children with CP between the ages of 5-20 will participate in the study. The Selective Control Assessment of the Lower Extremity (SCALE) questionnaire will be used to assess lower extremity selectivity, and the Edinburgh observational gait scale will be used to assess gait. Both assessments are observational.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 5-20
* Diagnosed with CP

Exclusion Criteria:

* Medical complications that limit participation in assessments (for example, severe visual impairment)
* Lower extremity surgery or botox surgery in the last 6 months
* Mental problems that cannot understand the commands given
CLE for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia

This study focuses on demonstrating the value of probe-based Confocal Laser Endomicroscopy (pCLE) in guiding endoscopic therapeutic procedures in Barrett's Esophagus (BE).

It is a randomized controlled outcomes study including patients already treated for Barrett's Esophagus lesion(s) and undergoing high definition white light endoscopy follow up procedure, with or without pCLE (2 arms will be considered in this study). The procedures will be carried out per standards of practice with appropriately trained physicians.

It is a randomized controlled outcomes study including patients already treated for Barrett's Esophagus lesion(s) and undergoing high definition white light endoscopy follow up procedure, with or without pCLE guided evaluation (2 arms will be considered in this study). The procedures will be carried out per standards of practice with appropriately trained physicians.

Eligibility Criteria:
Inclusion Criteria:

* Patients with BE with Intestinal Metaplasia, Low Grade-IntraEpithelial Neoplasia/High Grade-IntraEpithelial Neoplasia as the original indication for ablative treatment.
* Undergoing any type of endoscopic BE ablation treatment
* \<2cm of circumferential BE and \<5 total islands of BE on prior to last ablation.
* Age \> 18 years
* Ability to provide written, informed consent

Exclusion Criteria:

* Participation in another clinical study
* Circumferential BE
* Complete eradication of BE documented by biopsies
* Inability to obtain biopsies due to anticoagulation, varices, etc.
* Allergy to fluorescein
* Pregnancy
* Renal insufficiency
Atomoxetine, Placebo and Parent Management Training in Autism

The study will evaluate the effectiveness of atomoxetine (Strattera) with and without Parent Management Training (PMT) in children with Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDDNOS) who have symptoms of Attention Deficit Hyperactivity Disorder (ADHD). This is a double-blind placebo, parallel study where the atomoxetine will have a dose titration over a 6 week period. All children will be seen weekly during this titration period, with additional visits at Week 8 and Week 10. Families assigned to the PMT arm will have an additional weekly meeting with a clinician for a total of 9 PMT visits. PMT involves teaching parents to implement behavioral interventions with their children. Subjects who are clinical responders (ADHD Responders and Compliance Responders) from the 10 week study period will be followed every 4 weeks in a 24-week extension study. Subjects who are clinical nonresponders will continue in PMT if they received PMT during the double-blind phase, and they will receive an open trial of atomoxetine if they were on placebo during the double-blind phase. All subjects (responders and nonresponders) will be invited to participate in follow-up assessments every 4 weeks for 24 weeks after the completion of the double-blind phase.


Eligibility Criteria:
Inclusion Criteria:

* Children 5 yrs to 14 years 11 mos with clinical diagnosis of Autism, Asperger's Disorder, or PDDNOS based upon the ADI-R and clinical evaluation by DSM-IV criteria,
* Mental age equal to or greater than 24 months,
* ADHD symptoms based upon the CASI and clinical confirmed diagnosis,
* CGIS-S rating of 4 or grater for ADHD symptoms,
* A mean item score of \>1.5 on both the Parent and Teacher (non-parent caregiver) SNAP-IV 18 ADHD symptoms or the 9-symptom hyperactive-impulsive subscale (symptoms must be cross-situational),
* Reliable care provider available to bring subject to clinic visits and weekly sessions.

Exclusion Criteria:

* DSM-IV diagnosis of schizophrenia, schizoaffective disorder psychotic disorder NOS,bipolar disorder, or major depression (if accompanied by a family history of bipolar disorder) based upon evidence of suicidality, CASI, and clinical interview/history,
* Prior failed adequate trial of atomoxetine,
* Use of other psychotropic medications that produce CNS effects,
* Diagnosis of bipolar disorder, major depression, hypertension, cardiovascular disease, narrow angle glaucoma, other significant physical illness,
* Pregnancy or sexually active females (intercourse in the past 6 months, reported by either the subject or caregiver),
* Currently on effective medication treatment for ADHD,
* Prior involvement in Parent Management Training or other similar program,
* Currently on albuterol or taking beta blockers,
* Taking supplements or other complementary medical treatments where dose cannot be held at current level for duration of study