cyrilzakka/clinical-trials huggingface dataset:
Comparative Study of Amniotic Membrane Wound Graft In the Management of Diabetic Foot Ulcers

The purpose of this study is to determine whether the EpiFix human amniotic membrane is effective in the treatment of diabetic foot ulcers.


Eligibility Criteria:
Inclusion Criteria:

* Male or female age 18 or older
* Informed consent must be obtained
* Patient's ulcer must be diabetic in origin and larger than 1cm2. Debridement will be done prior to randomization. Subject's informed consent for participating in this study, must be obtained prior to proceeding with sharp debridement.
* Patients with Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA).
* Ulcer must be present for a minimum of four weeks direction, with documented failure of prior treatment to heal the wound.
* Patient's ulcer must exhibit no clinical signs of infection.
* Patient is of legal consenting age.
* Patient is willing to provide informed consent and is willing to participate in all procedures and follow up evaluations necessary to complete the study.
* Serum Creatine less then 3.0mg/dl
* HbA1c less than 12%
* Patient has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days:

  * Dorsum transcutaneous oxygen test (TcPO2) with results ≥30mmHg, OR
  * ABIs with results of ≥0.7 and ≤1.2, OR
  * Doppler arterial waveforms, which are triphasic or biphasic at the ankle of affected leg

Exclusion Criteria:

* Patients presenting with an ulcer probing to bone (UT Grade IIIA-D). A positive probe-to-bone will be confirmed when bone or joint can be felt with a sterile, ophthalmological probe.
* Patients whose index diabetic foot ulcers are greater than 25cm2.
* Patients considered not in reasonable metabolic control, confirmed by an HbA1c greater than 12% within previous 90 days,
* Patients whose serum creatinine levels are 3.0mg/dl or greater.
* Patients with a known history of poor compliance with medical treatments.
* Patients who have been previously randomized into this study, or are presently participating in another clinical trial.
* Patients who are currently receiving radiation therapy or chemotherapy.
* Patients with known or suspected local skin malignancy to the index diabetic ulcer.
* Patients on anticoagulant medication will as in any surgical procedure, be monitored according to the protocols employed at the enrolling center.
* Patients diagnosed with autoimmune connective tissues diseases.
* Non-revascularizable surgical sites.
* Active infection at site.
* Any pathology that would limit the blood supply and compromise healing.
* Patients that have received a biomedical or topical growth factor for their wound within the previous 30 days.
* Patient who are pregnant or breast feeding.
* Patient who are taking medications that are considered immune system modulator which could affect graft incorporation.
* Allergy to Gentamycin or Streptomycin.
Efficacy of Bortezomib (Velcade(R)) in Patients With Advanced Waldenström Macroglobulinemia

This trial is designed to evaluate the efficacy and toxicity of Bortezomib , an inhibitor of proteasome used in multiple myeloma, in patients with advanced Waldenström's Macroglobulinemia disease.

Open, prospective, multicenter, non controlled phase IIA trial

Primary objectives Evaluation of the efficacy and safety of Velcade in monotherapy for patients with advanced stage Waldenström Macroglobulinemia.

Secondary objectives Evaluation of the activity of the association of High Dose Dexamethasone (HD DXM) with Velcade for patients resistant to Velcade Alone For all patients

* Overall survival
* Safety
* Quality of life
* Duration of response

sample size: With type I error alpha of 5% and type II error beta of 20% and a two-sided test, the number of patients needed in this study is 34 Number of centers: 28 Centers participating to the French cooperative group CLL/WM

Eligibility Criteria:
Inclusion Criteria:

● Established diagnosis of Waldenström macroglobulinemia (the 2nd Workshop on Waldenstrom's macroglobulinemia)

Patient must have had 1 (or 2) lines of chemotherapy containing alkylating agent and/or Fludarabine :and /or monoclonal antibody and must have :

* Life expectancy \> 3 months
* Age \> 18 years
* ECOG performance status 0-1-2
* ANC \> 1 x 109/L
* Creatinine clearance, calculated according to the formula of cockcroft and Gault \> 40 ml/min
* Total bilirubin \< 2x ULN
* ASAT, ALAT \< 2x ULN
* A negative serum pregnancy test one week prior to treatment must be available both for pre-menopausal women and for women who are \< 2 years after the onset of menopause
* Adequate contraceptive methods for males and pre-menopausal females for 6 months after treatment discontinuation.
* Written informed consent
* Platelets\> 100X 109

Exclusion Criteria:

* Active secondary malignancy or chemotherapy/radiotherapy for any neoplastic disease other than Waldenström macroglobulinemia prior to the study
* Medical condition requiring the long-term (estimated to be more than one month) use of oral corticosteroids
* Patients with active bacterial, viral or fungal infection
* Known infection with HIV, Hepatitis B (except post vaccinal profile) or C
* Treatment with any, other investigational agent or participating in another trial within 30 days prior to entering this study
* Lactation/pregnancy
* Concurrent severe diseases which exclude the administration of therapy heart insufficiency NYHA grade III/IV, LEVF \< 50% and or RF \< 30%, myocardial infarction within the past 6 months prior to study
* Severe pulmonary or heart problems (acute diffuse pulmonary and pericardial disease)
* Severe chronic obstructive lung disease with hypoxemia
* Severe diabetes mellitus
* Hypertension difficult to control
* Impaired renal function with creatinine clearance \< 40 ml/min according to the formula of Cockcroft and Gault
* Cerebral dysfunction
* Richter's syndrome
* Neuropathy\> grade 1
* Positive Beta HCG
* Severe Hepato cellular alteration
Dynamics of Colonization and Infection by Multidrug-Resistant Pathogens in Immunocompromised and Critically Ill Patients

The goal of this observational study is to investigate how bacterial populations from the intestine and mouth of patients change during the hospitalization period and evaluate if some populations of specific bacteria increase or decrease the risk of acquiring an infection or becoming colonized by pathogenic bacteria. Participants will have the following samples collected during enrollment: stool samples (maximum 2x/week), blood draws (1x/week), oral swab (1x/week).

The objectives of this study are to dissect the main microbial, clinical, and antimicrobial resistance determinants that impact colonization and infection by vancomycin-resistant enterococci (VRE), extended-spectrum beta-lactamase producing Enterobacterales (ESBL-E), carbapenem-resistant Enterobacterales (CRE), and Clostridium difficile; to evaluate the role of commensal microbiota in VRE, ESBL-E/CRE, and C. difficile colonization, and to define the functional aspects of keystone microbiota and mechanisms of protection against colonization/infection.

Patients will be recruited from both intensive care units (n=500) and stem cell transplant units (n=500) and will be followed until discharge from these units, or for a maximum of four weeks. In addition to stool, blood, and oral samples, enrolled patients will have clinical data collected by chart review to evaluate colonization/infection-related clinical status, microbiological laboratory information, exposure to antibiotics, and clinical outcomes. Positive clinical cultures taken during the course of hospitalization will also be collected for analysis.

Eligibility Criteria:
Inclusion Criteria:

* Admission to an intensive care unit or stem cell transplant unit (for allogeneic stem cell transplantation) within previous 24 hours

Exclusion Criteria:

* \<18 years of age
* Pregnancy
* History of inflammatory bowel disease (Crohn's disease, ulcerative colitis)
* Gastrointestinal derivation (colostomy, ileostomy, etc.)
Hormonal and Metabolic Effects of Weight Loss

The investigators here propose to evaluate the hormonal and metabolic effects of weight loss, including evaluation of changes in several tissues.


Eligibility Criteria:
Inclusion Criteria:

* BMI \> 27 kg/m2 (adults)

Exclusion Criteria:

* pregnancy, breastfeeding
* patients with:

  * heart failure
  * impaired hepatic or renal function
  * anaemia
  * disturbed coagulation
  * infection, malabsorption
  * severe hypertension
  * any other endocrine disorder
Effect of Tolvaptan on Cognitive Function in Cirrhosis

Hypothesis: Tolvaptan will improve cognitive function, brain edema and health-related quality of life in cirrhotic patients with hyponatremia

Baseline assessment will include a

1. battery of eight cognitive tests
2. Health related quality of life
3. MRI head evaluating MR spectroscopy and diffusion tensor imaging

Patients will then be given tolvaptan 15-30mg qd for 14 days after which the tests will be repeated. During the first 3 days of tolvaptan administration, patients will be admitted and serum sodium will be drawn every 8 hours. 24 hr urine collection will also be performed.

Between the initiation and end of tolvaptan, patients will be seen at least every 3-5 days in between.

Participation will be terminated in case patients get transplanted or develop overt HE in between.

Eligibility Criteria:
Inclusion Criteria:

* Cirrhosis diagnosed by liver biopsy or radiological evidence of nodular cirrhotic liver or varices on endoscopy or laboratory features (platelet count \<150,000 with an AST/ALT ratio \>1).
* History of HE controlled on lactulose and/or rifaximin
* Last HE episode \>2 months prior to enrollment and \<2 episodes within 6 months
* Mini-mental status exam score ≥25
* Serum sodium \<130mg/dl within the last 14 days and the day of enrollment
* Availability of a caregiver
* Able to undergo MR of the head

Exclusion Criteria:

* Uncontrolled HE manifested by MMSE \<25
* Alcohol abuse within 3 months
* Illicit drug use within 3 months
* Psychoactive drug use other than regularly scheduled anti-depressants or methadone.
* Contraindication to MR examination (see attached MRI Safety Form)
* Placement of a transjugular intra-hepatic portosystemic shunt (TIPS)
* Creatinine Clearance less than 10 ml/min or undergoing hemodialysis
* HIV infection
* Use of azole medications
* Pregnancy
* Current use of tolvaptan, hypertonic saline or other medical therapies for hyponatremia
Carbohydrates and Children

This study will evaluate the impact of test carbohydrate blends on fat and carbohydrate oxidation, glucose, insulin and hunger scores in pre-adolescent boys and girls.


Eligibility Criteria:
Inclusion Criteria:

* Male 9 -13 years of age, or female 9- 10 years of age
* Tanner stage 1
* Subject was born full term
* Subject was born normal weight
* Subject passes the Physical Activity Readiness Questionnaire
* Body mass index \>5th percentile and \<95th percentile for age and gender
* Subject has voluntarily signed and dated a youth assent document

Exclusion Criteria:

* History of metabolic. endocrine, or hyperactivity disorders
* Allergy or intolerance to any ingredient found in the study products
* Participation in a concomitant trial of a non-registered drug or that otherwise conflicts with this study
Car Safety Seat and Gastroesophageal Reflux Disease

What's known? Prone position is no longer a treatment option for GERD because of the association with SIDS. Originally, positioning in an infant seat was recommended for infants with GERD. However, Orenstein proved this position has a detrimental effect on GER, compared to prone positioning.

What's new? Positioning in an infant seat caused no increase in GER, compared with the supine 15 degrees anti-Trendelenburg position. Except for the number of long reflux episodes, which was significantly higher in the car safety seat. Larger trials are needed for decisive conclusions.

OBJECTIVE - Over the past few decades, an increase in gastroesophageal reflux disease (GERD) has been seen in infants. This increase may be due to a continuous growth in the use of car safety seats. The objective of this study was to evaluate this hypothesis by comparing positioning in a car safety seat with the supine 15 degrees anti-Trendelenburg position.

PATIENTS AND METHODS - From October 2008 till August 2010 a crossover, randomized, controlled trial was performed on 31 infants, aged two weeks to six months old, who were suspected to have GERD. Twenty hour continuous esophageal pH monitoring was used to compare both positions.

RESULTS - The results of this trial demonstrated no differences between positioning in a car safety seat and in supine 15 degrees anti-Trendelenburg position for the reflux index, the duration of the longest reflux episode and number of reflux episodes (PRI = NS; PLRE = NS respectively PNRE = NS). Only the difference between the number of reflux episodes lasting longer than five minutes was significant (PNRE5 = 0,05).

CONCLUSIONS - The results of this study suggest that an increase in GERD is not caused by a growing use of car safety seats in infants. As the sample size was limited, larger trials are needed.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria were: healthy term-born infants between two weeks and six months old suspected to have GERD, in general good health. The infants did not need to meet the criteria for GERD to be eligible.

Exclusion Criteria:

* Exclusion criteria were infants with psychomotor retardation, acute illness or contra-indication for pH monitoring.
Study Evaluating the Safety and Efficacy of a Once-daily Dose of Tigecycline vs Ertapenem in Diabetic Foot Infections (DFI) With a Substudy in Patients With Diabetic Foot Infections Complicated by Osteomyelitis.

The purpose of this study was to look at the safety and effectiveness of a once-daily dose of tigecycline compared to ertapenem for the treatment of diabetic foot infections. The co-primary efficacy endpoints were not met.


Eligibility Criteria:
Main inclusion criteria:

* Men and women aged 18 or older with diabetes and a qualifying foot infection. People with evidence of a diabetic foot infection with osteomyelitis may qualify for the osteomyelitis substudy arm.

Main exclusion criteria:

* People with additional significant disease, infection with resistant pathogens, contraindication, or hypersensitivity to any test article or related antibiotic.
PNE With Therapeutic Exercises on Pain Intensity in Lumbar Radiculopathy

There is lack of structured pain neuroscience education in patients with lumber radiculopathy. Previously researches were done on pain neuroscience education before surgery of lumber radiculopathy. However this study will provide structured educational plan about pain neuroscience education along with therapeutic exercises to positively influence pain knowledge, dysfunction, and fear avoidance, limitation in movement and healthcare utilization in patients who have diagnosed with lumbar radiculopathy and don't want to undergo surgery.

Radicular pain or radiculopathy, defined as spinal nerve root dysfunction causing dermatomal discomfort and paresthesia's, myotome weakness, and/or reduced deep tendon reflexes, is frequently associated with axial spine pain. It affects both men and women and is believed to impact 3 to 5 percent of the population. Radiculopathy is pain that radiates down the legs and is described as electric, burning, and acute pain. Radiculopathy is most caused by irritation of a specific nerve, which can occur anywhere along the nerve and is most often caused by a compressive force. It could be caused by bulging or herniated discs, facet or ligamentous hypertrophy, spondylolisthesis, or even neoplastic or infectious diseases.

LR is the second leading cause of disability according to a research published by Global Burden of Disease (GBD).Pain neuroscience education (PNE), also known as therapeutic neuroscience education (TNE), is a series of instructional sessions for patients that cover the neurobiology and neurophysiology of pain, as well as how the nervous system processes pain. PNE alters the way a patient perceives pain at first. For example, a patient may have assumed that damaged tissues were the source of their pain; yet, after learning more about pain neurophysiology, the patient realises that pain may not accurately reflect tissue health and instead be caused by extra-sensitive nerves.

Eligibility Criteria:
Inclusion Criteria:

* Presence of lumbar radiculopathy ( disc bulge , disc herniation , lumbar stenosis, disk dehydration(13)
* Medication. (Patient already on prescriptions, using medicines)
* Duration of low back pain as the main symptom for at least 3 months

Exclusion Criteria:

* The presence of chronic-pain-related conditions (e.g. fibromyalgia, chronic fatigue syndrome.)
* Pregnancy
* Patients on treatment with alternative therapies.
* Patients with associated pathologies that make it impossible to perform a physical exercise program (myopathies, neurological diseases with significant impairment of functionality
Vojta Therapy in Multiple Sclerosis.

This Study evaluates the effectiveness of a Vojta locomotion reflex program as short-term automatic postural control in patients with Multiple sclerosis

In two consecutive weeks two interventions will be conducted: Vojta group(A) and standard therapy group(B). The last one is based on balance exercises targeting core stability, Bobath concept and sensory strategies. In the Vojta group 5 sessions will be conducted for a duration of 2 weeks and the same will be realised on the standard group. In addition, during the study, a daily activity shall be prescribed in both groups: Vojta exercise during 20 minutes for group A and walking for 20 minutes in group B.

Eligibility Criteria:
Inclusion Criteria:

* Final diagnosis of MS according to McDonald criteria.
* Walkability with or without assistance (4.0 to 6.5 in EDSS) and dysfunctions defined by the inability to hold the tandem position for 30 seconds with the arms close to body.
* Older than 18 years-old.
* Escorted sessions, a family member or close person.

Exclusion Criteria:

* Phase outbreak or outbreak in the 3 months before the study.
* Medication that prevents or limits the performance of the Locomotion reflex.
* Participation in other studies during the conduct of this study.
* Score inferior to 6 in the Abbreviated Mental Test that prevents understanding of the study consent or that limits the understanding of the test during its realisation.
Phase I-IIa, to Evaluate the Safety, Feasibility, and Efficacy of the Use of BIOCLEFT in the Treatment of Cleft Palate.

Phase I/II, controlled, open-label, randomized, single site clinical trial to assess the safety and feasibility, as well as hint efficacy evidence of a bioengineered palate mucosa substitute on nanostructured fibrin-agarose scaffolds with autologous mucosa tissue-specific cells (culture-expanded fibroblasts and keratinocytes), for tissue replacement and repair of donor area after the reconstruction of palate cleft defects (staphylorraphy), in comparison with standard care for donor mucosa.

The initial phase of the trial is non-randomized, and involves the sequential recruitment of 5 eligible subjects with a minimum safety period of 30 days between them. All of them will be implanted with the autologous human palatal mucosa substitute of nanostructured fibrin-agarose generated by tissue engineering (BIOCLEFT), after reconstruction of the palate. Once the 5th treated patient has reached 1.5 months of follow-up after the intervention (Visit 8), the safety and feasibility data analysis will be carried out by the Independent Data Safety and Monitoring Committee (interim analysis), after which will allow continuation to the randomized phase of the trial, if the results allow it.

In the second phase, the rest of the patients (10) will be recruited, who will be randomized 1:1, such that 5 of these patients will be implanted with the investigational medication while undergoing standard surgical reconstruction. (uranostaphyllorrhaphy), while the other 5 will only undergo standard surgical reconstruction and will constitute the control group.

The total number of patients to be included in the study will be 15, who will be followed for 24 months according to a protocolized scheme that includes 2 pre-implant visits, 1 implant visit and 9 post-implant evaluation visits.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients, of both sexes.
* Diagnosis of total unilateral non-syndromic cleft lip and palate (FLPNS) that will undergo surgery for correction.
* Children who have previously donated a sample of oral mucosa during the cleft lip repair procedure (cheiloplasty).
* Informed consent signed by one or both parents (or legal guardian) adequately informed of the study and willing to follow the trial procedures and instructions.

Exclusion Criteria:

* Active infectious diseases.
* Allergies or hypersensitivity to any of the components/excipients of the Investigational Product.
* Severe hematological disorders/blood dyscrasias.
* Severe hepatic or renal dysfunction/failure.
* Serious endocrine disorders/dysfunctions.
* Malignant neoplasms
* Active HIV, HBV or HCV infection.
* Metabolic bone diseases (Paget's disease, hypercalcemia, etc.).
* Children with cleft lip and palate who present other congenital malformations that, in the opinion of the researcher, could affect the result of the study or the interpretation of the results of the study.
* Any other pathology that in the opinion of the investigator should not be included in the study for other medical or social reasons.
Internet-CBT for Parkinsons Disease

The aim of the study is to investigate if an Internet-based psychological treatment based on principles from Cognitive Behavioral Therapy can increase function and quality of life for patients with Parkinson disease.

The Internet-based Cognitive Behavioral Therapy (ICBT) will be given as an adjunct to the Standard Medical Treatment. ICBT will be compared to Standard Medical Treatment alone (SMT).

A secondary aim is make a preliminary evaluation of the ICBT-program with less and less active therapist support. It is hypothesized that both active treatments will be superior to SMT in improving quality of life and functioning and that ICBT with full therapist support will be superior to ICBT with lower level of therapist support.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed Parkinson disease
* WSAS score of over 17
* Access to a internet connected device and a mobile phone capable of receiving SMS

Exclusion Criteria:

* Substance or alcohol abuse
* Psychotic Disorder or Bipolar disorder
* Other psychiatric disorder that requires immediate attention or hinders the offered ICBT treatment
* Practical obstacles such as difficulties using the technology required to participate in the study, not having the time to actively wok with the treatment, or having symptoms from Parkinson to severe to be able to actively participate in the study
* High suicide risk, defined as:
* 5 or 6 points on the question about Suicidal thoughts on the Montgomery-Asberg Depression Scale (MADRS)
* A standardized clinical interview on suicidal thoughts if the score on the above question is 4