cyrilzakka/clinical-trials huggingface dataset:
Contacting Authors to Retrieve Individual Patient Data

The objective of this study is to examine the impact of incentivizing authors of RCTs that are eligible for a systematic review and meta-analysis, versus usual contact strategies to obtain original IPD


Eligibility Criteria:
Inclusion Criteria:

* Corresponding authors of RCTs included in our previous and updated systematic reviews

Exclusion Criteria:
Associative Memory in Autism Spectrum Disorder

The aim of this study is to investigate the neural substrates of associative memory in Autism Spectrum Disorder using both behavioural and EEG assessments.


Eligibility Criteria:
Inclusion Criteria:

* Right handed children from 10 to 18 years old
* Informed consent signed by the legal representative and adolescent himself.
* Medical Examinations, psychopathology, and cognitive examination in accordance with inclusion and exclusion criteria specific to each population:

  * People with ASD:

    * Participants with ASD without mental retardation with a diagnosis in reference to the DSM V criteria
  * Controls : Participants without ASD

Main exclusion criteria:

* mental retardation,
* schizophrenia,
* ADHD,
* head injury with lost of consciousness
Study of the ICG Distribution in the Margins of Breast Cancer After Tumorectomy

We will observe if ICG fluorescence correlates with margins of breast tumours after iv injection of the contrast agent

In the operating room:

ICG 0.25 mg/kg will be given as an iv injection at least 20 minutes before the beginning of the operation.

The surgeon will remove the tumour (and the axillary lymph nodes) as usual.

Optionally, peroperative "in vivo" imaging of the dissection of the tumour using the PDE camera will be performed.

In the Laboratory of Pathology:

The "fresh" tumorectomy piece will be processed as usual, and the thick sections for the evaluation of the margins as well as the tissues samples from each margins will be imaged using the PDE in comparison with the fluorescence in the mid part of the tumour and the fluorescent areas will be so delimited (and later analyzed in comparison with standards of known fluorescence intensity).

After fixation, the tumoral tissues will be thereafter processed "as usual".

If fluorescent foci are identified at the level of the axillary piece (in case of CALND), they will be dissected and processed as other lymph nodes. Additionally, metastatic lymph nodes -if present- will also be controlled for their microscopic fluorescence or not.

Using the near-infrared fluorescence microscope, the slides corresponding to the macroscopically fluorescent structures will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histopathological diagnosis of mammary cancer who are candidate for tumorectomy, either with SLN selective lymphadenectomy, or with complete axillary node dissection,
* Informed consent form signed.

Exclusion Criteria:

* Diagnosis of mammary cancer established by "gross" biopsy,
* Age less than18 years old.
* Inability to give informed consent.
* History of allergy or hypersensitivity against the investigational product (its active substance or ingredients), to iodine or to shellfish.
* Apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or disseminated autonomies of the thyroid gland.
* Documented coronary disease.
* Advanced renal impairment (creatinine \> 1,5mg/dl).
* During the 2 weeks before the enrolment, concurrent medication which reduces or increases the extinction of ICG (i.e. anticonvulsants, haloperidol and Heparin).
* Pregnancy, breastfeeding
Preoperative Intravenous Omega 3 Fatty Acids Administration in Elderly Patients Undergoing Hip Surgery

The perioperative administration of n-3 fatty acids has been shown to lead to favorable effects on outcome in patients with severe surgical interventions by lowering the magnitude of inflammatory response and by modulating the immune response. No study with preoperative administration of IV omega 3 fatty acids as a part of total parenteral nutrition (TPN) or monotherapy with it to demonstrate its effects on inflammatory and immune response has been conducted. So, this study has been planned to judge the inflammatory response of preoperative monotherapy with IV omega 3 fatty acids in elderly patients undergoing hip surgery considering the hyper-inflammation associated with this type of surgery in elderly patients.


Eligibility Criteria:
Inclusion Criteria:

1. Elderly male or female patients undergoing hip surgeries
2. Age \> 60 years
3. The patients who give written informed consent

Exclusion Criteria:

1. Refusal to participate in the study
2. Allergy to any of the constituents of nutritional products
3. HIV positive patients, patients with primary diagnosis of hypertriglyceridemia, patients on long term steroid therapy and cyclooxygenase inhibitors (more than 3 months)
4. Severe cardiac disease, hepatic disorders (total bilirubin \> 1.5 times the upper limit of normal), psychiatric disorders likely to affect compliance, severe hemorrhagic disorders, stroke, embolism
5. Uncontrolled severe renal failure (Serum creatinine \> 2 mg/dL) without dialysis/hemofiltration
6. Participation in any other clinical trial within the last 2 months
Photodynamic Therapy With LUZ11 in Advanced Head and Neck Cancer

This study will investigate the tolerability, recommended dose and pharmacokinetics of LUZ11 following photodynamic therapy (PDT) of patients with advanced head and neck cancer.

LUZ11 is a new photosensitizer for use in photodynamic therapy (PDT) of solid tumors, such as head and neck cancer. PDT with LUZ11 involves the intravenous administration of LUZ11 followed by irradiation of the target tumor with laser light of an appropriate wavelength. The light causes the drug to react with oxygen, which forms reactive oxygen species (ROS) locally and induces tumor cells death and damages the blood vessels of the tumor thus preventing it from receiving nutrients.

The primary objective of this study is to assess the tolerability of LUZ11 following single ascending doses of LUZ11. The secondary objectives of this study are to explore the LUZ11 dose that has anti-tumor effect following photoactivation and to determine LUZ11 pharmacokinetics.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Men or non-pregnant, non-breast feeding women
* Karnofsky performance status of 60% or greater
* Histologically confirmed recurrent/refractory squamous cell carcinoma of the head and neck
* Clearly visible tumor on the oral cavity or cutaneous surface

Exclusion Criteria:

* Known hypersensitivity to any of the formulation ingredients
* Known hypersensitivity to porphyrins
* Porphyria or other diseases exacerbated by light
* Tumors known to be eroding into a major blood vessel in or adjacent to the irradiation site
* Planned skin phototherapy session(s) within the study timeframe
* Planned surgical procedure within the study timeframe
* Coexisting ophthalmic disease likely to require slit-lamp examination within the study timeframe
* Existing therapy with a photosensitizing agent
* Unstable angina and/or congestive heart failure requiring hospitalization within 6 months prior to screening
* Myocardial infarction within 6 months prior to screening
* Contraindication to MRI with gadolinium
* Unacceptable laboratory abnormalities
* Clinically relevant 12-lead ECG abnormalities
GIP Receptor Antagonist Studies in Humans

Antagonizing GIP effects during hyperglycaemia in healthy subjects and measurements of insulin secretion.

Aim: To evaluate the GIP receptor antagonizing effect of peptide-based competitive GIP receptor antagonist GIP-A (vs. saline (placebo)) in 10 healthy subjects during 1 hour hyperglycaemic clamps with and without concomitant iv infusion of GIP\[1-42\]. The intention is to establish GIP-A as a tool to eliminate glucose-dependent insulinotropic GIP signalling.

The study consists of four experimental days (A-D) with assessment of beta cell function during 12 mM-hyperglycaemic clamps with concomitant infusions of A) GIP\[1-42\], B) GIP-A, C) GIP\[1-42\] + GIP-A, or D) saline (placebo).

Eligibility Criteria:
Inclusion Criteria:

* Normal kidney function, liver function and hemoglobin levels.

Exclusion Criteria:

* Medication, Diabetes type 1 or 2, BMI \> 25, first degree relatives with Type 2 Diabetes
Minimally INvasive Colon Cancer Surgery Through IMmunomics and Optical Mapping of the Sentinel Lymph Node.

The project investigates the feasibility of laparoscopic fluorescent imaging for the intraoperative detection of the sentinel lymph node (SLN) in colon cancer patients. In addition, the topology of immunological and microenvironmental changes in normal and invaded lymph nodes (LN's) will be correlated to the LN location (anatomical mapping).


Eligibility Criteria:
Inclusion Criteria:

* Tumor type: proven adenocarcinoma of the colon
* Extent of disease (AJCC 7th edition): clinically node negative (stage II) non-metastatic colon cancer
* Locally resectable disease
* Adequate mental faculty, allowing to understand the proposed treatment protocol and provide informed consent
* Laboratory data

  * Serum creatinine ≤ 1.5 mg/dl or a calculated GFR ≥ 60 mL/min/1.73 m2
  * Serum total bilirubin ≤ 1.5 mg/dl, except for known Gilbert's disease
  * Platelet count \> 100,000/µl
  * Hemoglobin \> 9g/dl
  * Neutrophil granulocytes \> 1,500/ml
  * International Normalized Ratio (INR) ≤ 2
* Absence of alcohol and/or drug abuse
* No inclusion in other clinical trials interfering with the study protocol
* No concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy
* Absence of any severe organ insufficiency
* No pregnancy or breast feeding
* Adequate contraception in fertile patients
* Written informed consent

Exclusion Criteria:

* Node positive and/or metastatic disease
* Locally unresectable disease
* Medically unfit patients (Karnofsky index \< 70%)
* Allergies to any of the procedural substances (allergy to iodides, hypersensitivity to products containing human albumin)
Urinary 8-isoprostane is Elevated in Acute Childhood Asthma

Oxidative stress is seen in children with asthma, but is hard to measure. The investigators exploring the utility of using a commercially available assay to measure oxidative stress in the urine in asthmatics. Additionally, the investigators will attempt to prove that oxidative stress is higher in children with acute asthma compared to those with stable asthma and that this stress is also higher in children with more severe clinical asthma exacerbations compared to less severe ones.


Eligibility Criteria:
Inclusion Criteria:

Group 1

1. Patients aged 4-18 years
2. Known stable asthmatics on no medications or with no medication changes in 3 weeks prior to enrollment
3. No asthma hospitalizations in past 3 months
4. Parent available to consent

Group 2

1. Patients aged 4-18
2. Known asthmatic, admitted to Stony Brook University Hospital for status asthmaticus
3. Parent available to consent

Exclusion Criteria:

1. Any child with documented fever within 24 hours of study entry
2. Any child with a known current history of tracheo- or bronchomalacia
3. Any child with known clinical or laboratory evidence of shock (see below)
4. Any child with history of documented immunodeficiency, rheumatologic disease, cystic fibrosis, or renal dysfunction (see below)
5. Any child with a current or recent (less than 1 year) history of tracheostomy
6. Any child with a known genetic abnormality
7. Any pregnant child
8. Any child with a history of autism
9. Any child whose parent/caregiver is unable to give informed consent
Acute Appendicitis: Active Observation With and Without Antibiotics

This study evaluates if early provision of antibiotics is a superior treatment compared to "traditional wait and see" with regard to symptom relief for suspected acute uncomplicated appendicitis.

Recent long-term follow up results of antibiotic treatment of acute appendicitis in unselected populations indicate that approximately 70-80 % of patients respond to antibiotics, while the remaining 20-25% need an operation. Antibiotic treatment was associated with significantly fewer severe and non-severe complications compared to surgery. Therefore, antibiotic treatment can be regarded as safe and effective initial treatment of acute appendicitis based on evidence.

However, it remains to be evaluated to what extent antibiotic treatment is more effective compared to the most conservative application of procedures in the care of patients with acute appendicitis. A well- recognized approach in Sweden is watchful waiting at in-hospital conditions. A certain number of patients with suspected uncomplicated appendicitis will likely recover without any active treatment, but controlled evidence are lacking to what extent such recoveries may occur in the short- and long-term perspective.

The hypothesis is that antibiotic treatment is superior to active observation with regard to symptom relief at suspected acute appendicitis in selected patient groups.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with suspected appendicitis.
* Age\<60 years.
* C-reactive protein \< 60 mg/L.
* White blod cell Count (leucocytes) \< 13 e9 /L.

Exclusion criteria:

* Pregnant
High Speed Circuit Training and Cognition

The purpose of this research study is to see if a weight training program can make a positive change in participant fitness as measured by the ability to use oxygen and help the participant remember things.

The purpose of this research study is to see if a weight training program can make a positive change in cardiac fitness, that is a person's ability to use oxygen; and, if the program can help a person's memory, as measured by some standard tests. The researchers will also ask the participant to attend two sessions with researchers at the Bascom-Palmer Eye Institute so they can take pictures of the participants' eyes to see how training changes the number of blood vessels. This can be used by doctors and other clinicians to evaluate improvements blood flow to the brain due to training.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women between 60 and 85 years of age (inclusive)
2. Ability to provide informed consent
3. No medical contraindication to participation in an exercise program including unstable or active untreated major medical illness (i.e., cardiovascular disease, neurological or neuromuscular diseases, stroke, cancer, etc.).

Exclusion Criteria:

1. Existing muscle-skeletal injury
2. Mini-mental score \<18
3. Enrolled in another exercise program
4. Unstable or active major medical illness
5. Answer "Yes" to any questions on the Elder PAR-Q
6. Pregnancy
Validation Study for Disability Assessment Functional of Patients With Inflammatory Diseases Intestinal Chronic (VALIDate)

Inflammatory Bowel Diseases (IBD) often affect psychological, family, social and professional dimensions of patients' life, leading to disability which is essential to quantify as part of Patient-Reported Outcomes (PROs) newly included in the therapeutic targets to reach in IBD patients. Up to now, the IBD-Disability Index (IBD-DI) was the only validated tool to assess functional status, but it is not appropriate for use in clinical practice. The IBD Disk was then developed, a shortened and self-administered tool, adapted from the IBD-DI, in order to give immediate representation of patient-reported disability. However, the IBD Disk has not been validated yet in clinical practice. The aims of the VALIDate study is to validate this tool in a large population of French IBD patients and to compare it to the already validated IBD-DI.

The IBD-Disk has not been evaluated in clinical practice and has not yet been validated. but the interest of rapid assessment of the disease led the physicians in University Hospital of Nantes' department, some of whom had participated in the construction of this tool, to use it in routine practice for consultations of patients with IBD, joined by many gastroenterologists from other hospitals including the University Hospitals of Rennes and Angers.

The objective of this study is to validate this tool and prove its effectiveness by comparing it to the gold standard represented by the IBD-DI, in the same way that the PsoDisk has been validated prospectively compared to other tools for evaluating the quality of life and activity of psoriatic disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes
* aged over 18 with an established diagnosis of IBD (Crohn's Disease, Ulcerative Colitis or IBD unclassified)

Exclusion Criteria:

* ongoing pregnancy or breast feeding woman
* vulnerable people i.e. Adults under a legal protection regime (guardianship, trusteeship, judicial safeguard )
* insufficient command of French language and relevant psychiatric comorbidities (both of them making the self-questionnaire difficult to fill in)
* uncertain IBD diagnosis
Point-of-Care Echocardiography With Assistance Technology

Establish the effectiveness of the Bay Labs, Inc. EchoGPS software in enabling RNs to acquire echocardiograms. In this study an echocardiogram protocol using the EchoGPS interface with the Terason uSmart 3200t, an FDA 510(k)-cleared, commercially available ultrasound device will be performed. Participants will have two scans, one by a registered nurse (RN) using the Terason uSmart 3200t with EchoGPS (Study Exam) and one by a sonographer using the Reference Device without EchoGPS guidance (Control Exam), under the same protocol. Study is non-significant risk (NSR).

To validate clinical use of Bay Labs, Inc. EchoGPS guidance software by registered nurses (RNs) with no prior scanning experience to acquire limited two-dimensional echocardiograms. In this study an echocardiogram protocol using the EchoGPS interface with the Terason uSmart 3200t, an FDA 510(k)-cleared, commercially available ultrasound device will be performed. Participants will have two scans, one by a registered nurse (RN) using the Terason uSmart 3200t with EchoGPS (Study Exam) and one by a sonographer using the Reference Device without EchoGPS guidance (Control Exam), under the same protocol. Study is non-significant risk (NSR).

Eligibility Criteria:
Inclusion Criteria:

All patients must meet the following inclusion criteria to participate in the study:

* Patients scheduled for an echocardiographic examination
* Patients ≥18 years old

Exclusion Criteria:

Patients must NOT meet any of the following exclusion criteria to participate in the trial:

* Unable to lie flat for study
* Patients experiencing a known or suspected acute cardiac event
* Patients with severe chest wall abnormalities
* Patients who have undergone pneumonectomy
* Patients unwilling or unable to give written informed consent
Brain Activity Changes Following Neuroproprioceptive Physiotherapy in Multiple Sclerosis

Imaging methods bring new possibilities for describing the brain plasticity processes that underly the improvement of clinical function after physiotherapy in people with multiple sclerosis (pwMS). The study determined whether facilitation physiotherapy could enhance brain plasticity, compared two facilitation methods, and looked for any relation to clinical improvement in pwMS.

The study was designed as parallel group randomized comparison of two kinds of physiotherapeutic interventions referred to healthy controls.

MS patients were examined by fMRI (primary outcomes) and clinical tests (secondary outcomes) at the beginning of study. Then, they were randomly divided into two groups (by drawing lots in a 1:1 ratio). The first group underwent Vojta reflex locomotion (VRL), and the second Motor Program Activating Physiotherapy (MPAT). The length and intensity of treatment was the same in both groups (two months, one hour twice a week). After the treatment, a clinical and fMRI examination was performed. Healthy volunteers underwent an fMRI examination that was considered to be a control.

Eligibility Criteria:
Inclusion Criteria:

* definite MS
* stable clinical status in the preceding 3 months
* imuno-modulatory treatment for at least two years (including glatiramer acetate, interferon beta-1a, 1b, mitoxantrone, fingolimod, natulizumab)
* Expanded Disability Status Scale (EDSS)≤6
* predominant motor impartment
* six months or more without any physiotherapy
* ability to undergo ambulatory physiotherapy

Exlusion criteria:

-other neurological disease or conditions disabling movement
Efficacy and Safety of Garamycin® Sponge in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection

The purpose of this study is to determine whether Garamycin Sponge (Gentamicin-Collagen sponge) in combination with antibiotics is safe and effective in treating moderate and severe diabetic foot infections.

Infected skin ulcers with diabetes can be very debilitating because they are difficult to heal. Diabetic ulcers are responsible for frequent health care visits, and are a major predictor of amputation. Diabetic ulcers can be caused by a patient's inability to sense pain or warmth as well as peripheral vascular disease, which causes diminished blood flow to the foot. Early aggressive treatment is necessary to treat infection and ultimately prevent the need for amputation.

Gentamicin is an antibiotic that is effective in treating certain kinds of infection. Collagen is a protein that is found in all mammals. The gentamicin sponge being used in this study is commercially available in Switzerland as Garamycin® Sponge. The Garamycin Sponge is a thin flat sponge made out of collagen that comes from bovine tendons and containing gentamicin. When applied to an open ulcer, the collagen breaks down and the gentamicin is released into the ulcer, but very little is absorbed into the blood stream. The high levels of gentamicin in the open infected ulcer may help treat the infection.

All subjects will be given the necessary supplies and taught how to take care their foot ulcer. All subjects will also receive oral an antibiotic. Additionally, subjects who are randomly assigned to receive the gentamicin-collagen sponge will place a gentamicin-collagen sponge on their ulcer during daily wound care.

Eligibility Criteria:
Inclusion Criteria:

* Is aged ≥ 18.
* Has diabetes mellitus, according to the American Diabetes Association (ADA) criteria.
* Has an open foot wound with visible inflammation, namely at least 1 skin ulcer located on or below the malleolus that presents with the following clinical manifestations of a moderate or severe infection based on the Infectious Disease Society of America (IDSA).
* Has received appropriate surgical intervention to remove all necrotic and infected bone if diagnosed with osteomyelitis
* Meets certain minimal laboratory criteria.

Exclusion Criteria:

* Has an ulcer infection which, based upon the patient's known history of hypersensitivity cannot be appropriately treated with at least one of the empiric systemic antibiotic regimens per protocol.
* Has received \> 48 hours of potentially effective antibiotic therapy and the wounds are clinically improving. If a patient has received an antibiotic within 72 hours, but is not improving or deep-tissue culture results indicate that the infecting pathogen is not susceptible to that antibiotic, the patient may be enrolled.
* Requires or is likely to require treatment with any concomitant topical product or wound therapy during the study period.