cyrilzakka/clinical-trials huggingface dataset:
Comparative Study of Two Tetanus Toxoid Vaccination Strategies: Cold Chain Versus Controlled Temperature Chain

The purpose of this study is to determine the effectiveness, safety and feasibility of a tetanus toxoid (TT) vaccination strategy relying on the maintenance of vaccines in a controlled temperature chain (CTC). The CTC is defined as the storage and transport of vaccines within a temperature range appropriate to the heat stability profile of TT vaccine. In this study vaccines are transported and stored in the cold chain up to district level. From district to beneficiary level vaccines are exposed to ambient temperatures during a limited period of time.

In an initial phase, the stability of 3 lots of TT vaccine kept in CTC is determined. For this, the potency, safety, pH and adsorption of vaccines maintained in CTC will be tested in the laboratory and compared to vaccines that have been maintained in cold chain. If all parameters (i.e. potency, safety, pH and adsorption) are above WHO specifications the strategy in CTC will be used.

Only if the laboratory results are adequate, villages will be assigned to one of the vaccination strategies. All women between 14 to 49 years of age in the selected villages who fulfill the inclusion criteria will be invited to participate.

In order to determine the baseline anti-tetanus protection, TT vaccination history will be collected from all participants using a standardized questionnaire. Women who have already received at least 2 doses of TT vaccine will be excluded from the study. Moreover, blood will be collected from all participants to later verify in laboratory the baseline protection.

A first dose of TT vaccine will be given according to the assigned strategy (CTC or cold chain). Four weeks after the 1st vaccination, a second TT vaccine will be given using the same strategy employed for the first dose. Finally, four weeks after the second dose, a blood sample will be collected from all participants who received two doses of vaccine. The serological responses will be compared in the group that received two doses of TT vaccine maintained in cold chain ant the group that received two doses of vaccine maintained in CTC.


Eligibility Criteria:
Inclusion Criteria:

* Women aged between 14 to 49 years of age
* Living in the district of Moïssala, Chad
* Have no proof of previous vaccination or previous vaccination is not greater than 1 dose of vaccine
* Previous dose received more than 1 month before
* Consented to be included in the study

Exclusion Criteria:

* Allergic reaction to previous tetanus vaccination
* Severe febrile illness
* Have received a tetanus vaccine within the previous month
* Refuses vaccination or does not consent
* Nomadic population travelling before the end of the study
* Pregnant women due to deliver within 2 weeks
Sirolimus Therapy for Poor Prognosis Immunoglobulin A Nephropathy

The purpose of this study is to test in a pilot trial the efficacy and tolerance of sirolimus oral (at low doses) in patient to treat poor-prognosis IgA Nephropathy.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 70 and with capacity to grant informed consent
* Biopsy-proven IgA nephropathy by means of standard immunohistochemical and morphological criteria
* Renal biopsy in the in the 3 months prior to randomization date
* Absence of known hepatic, cardiac, pulmonary or intestinal disease
* Glomerular filtrate estimated by Cockcroft-Gault, more than 30 ml/min
* Any of the following clinical states: a) High blood pressure defined as systolic blood pressure higher than 140 mmHg or diastolic blood pressure higher than 90 mmHg associated with proteinuria between 0.3-1 g/day and/or microhematuria. b) Proteinuria higher than 1g/day
* Women of child-bearing age will follow a suitable contraceptive method, and a negative pregnancy test will be needed before inclusion in the study

Exclusion Criteria:

* Serology positive for HIV or hepatitis B infection (defined as positive for the HbsAg antigen) or hepatitis C infection (defined as viral RNA detection)
* Treatment with steroids or immunosuppressors in the two previous years
* Evidence of active infection at the time of inclusion in the study
* Pregnancy or breastfeeding at the time of inclusion in the study
* Estimated glomerular filtration \< 30 ml/min, bilirubin \> 2 mg/dl, or ALT or AST two times higher than the normal upper limit
* Diabetes Mellitus, defined as patients treated with insulin or oral antidiabetics or glycemias higher than 140 mg/dl in two or more episodes
* Poor control of high blood pressure (defined as systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg, taking 3 or more antihypertensives) or evidence or suspicion of renovascular disease
* Thrombocytopenia less than 100,000 /mm3 or total neutrophil value lower than 2000 /mm3 or triglycerides value \> 400 mg/dL (4.6 mmol/L) or cholesterol \> 300 mg/dL (7.8 mmol/L) or LDL \> 200 mg/dL
* IgA nephropathy systemic forms, i.e., Schönlein-Henoch purpura, IgA nephropathy secondary forms, post-renal transplant IgA nephropathy recurrences, cases presented in the form of rapidly progressive renal failure and cases with the presence of cellular crescents in more than 50% of the glomeruli will be excluded
* History of cancer in the previous 5 years,exception of skin basocellular carcinoma and uterine in situ carcinoma (completely removed both of them)
* Know intolerance to Sirolimus or macrolides
Primary Patency in Post-angioplasty Dysfunctional Arteriovenous Fistula in Renal Dialysis: Paclitaxel-releasing PTA Balloon Catheter vs PTA Balloon

In recent years the use of paclitaxel releasing percutaneous transluminal angioplastic (PTA) balloon catheter is spreading in vascular pathology, mainly in stenosis infrainguinal arteries. This device combined the mechanical action of PTA balloon with the antiproliferative effects of paclitaxel. The use of these devices in venous pathology is limited. This devices could improve the treatment of renal dialysis arteriovenous fistula stenosis.


Eligibility Criteria:
Inclusion Criteria:

* Patient with renal dialysis with arteriovenous fistula (AVF) at least 3 months before.
* Patient diagnosed with AVF stenosis by clinical and radiological criteria
* Sign informed consent

Exclusion Criteria:

* Pregnant or breastfeeding
* Patients with AVF stenosis not could be treated with PTA catheter
* Paclitaxel allergy
* Iodinated contrast allergy
* Local or systemic active infection
* Life expectancy less than 12 moths
Evaluation of the Efficacy of OMK2 in Recovering Corneal Neural Damage in Patients With Diabetes

This will be a single-centre, randomized, pilot study. 30 patients with diabetes who previously had received Argon laser photocoagulation will be enrolled.

This will be a single-centre, randomized, pilot study. 30 patients with diabetes who previously had received Argon laser photocoagulation will be enrolled. These patients will receive corneal esthesiometry and will be divided in those with esthesiometry \< 45 mm \[6\] (clinically detectable corneal neuropathy, CDCN) and not (NCDCN).

Patients will be randomized to the two treatment arms: 20 patients will be treated with active treatment (OMK2) and 10 patients will be treated with placebo (lubricant eye drops) given three times daily (8 am, 2 pm, 8 pm) for 18 months. Stratification for (1) CDCN, (2) duration of the disease, and (3) insulin-dependent diabetes will be adopted.

The randomization will be operator-masked.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Type 1 or type 2 diabetic patients who received Argon Laser Photocoagulation

Exclusion Criteria:

* Neuropathy of any other cause than diabetes
* A history of conditions known to affect corneal sensitivity
* Coexisting other corneal diseases
* Autoimmune diseases
* Sjogren syndrome
* History of corneal trauma
* Contact lenses users
* Patients needing eye surgery or who received eye surgery at least 180 days before study beginning.
* contraindications to the use of any active substances and/or excipients
* pregnant and lactating women
* pediatric patients or adolescents under 18 years
Percutaneous Electrical Stimulation on Radial Nerve in Patients With Lateral Epicondylalgia

Lateral epicondylalgia is a common musculoskeletal condition that approximately affects 1-3% of the general population. Several authors have found greater mechanical pain sensitivity in the radial nerve when compared with healthy subjects. Radial tunnel syndrome exhibits a similar clinical presentation to lateral epicondylalgia. Percutaneous electrical stimulation has shown reduce pain in several conditions. Percutaneous electrical stimulation on the radial nerve could cause an important relief in lateral epicondylalgia.

Hypothesis: Percutaneous electrical stimulation on radial nerve plus exercise therapy in patients with lateral epicondylalgia is better than sham percutaneous electrical stimulation plus exercise.

Randomized, double-blind, placebo controlled clinical trial, using Percutaneous Electrical Nerve Stimulation (PENS). PENS is technique to provide a transcutaneous electrical nerve stimulation current throughout needling filaments place close to the nerve.

Study Aims:

Aim #1: The primary aim of the study is to compare the effect of the immediate, short, medium and long-term of PENS on intensity of pain as measured by visual analogue scale (VAS) in patients with lateral epicondylalgia with random assignment to two treatments: PENS plus exercise program or Sham PENS plus exercise program.

Aim #2: The secondary aim of the study is to compare the effect of the immediate, short, medium and long-term of PENS on pain free grip strength, disability as measured by Patient Rated Tennis Elbow Evaluation (PRTEE) and DASH questionnaire and pressure pain threshold (PPT) and area and distribution of pain in patients with lateral epicondylalgia with random assignment to two treatments: PENS plus exercise program or Sham PENS plus exercise program, and determine if psychological factors (fear and avoidance and catastrophism) change with any of the treatments and if is related with the primary and secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Lateral epicondylalgia symptoms confirmed with at least 2 of the 4 following test:

  1. pain during palpation of lateral epicondyle
  2. pain on resisted wrist extension
  3. pain on resisted middle finger extension
  4. pain during hand-grip.

Exclusion Criteria:

* History of fractures, luxations, surgery and/or musculoskeletal disorders in upper limb.
* Neurological disorders, inflammatory and/or degenerative diseases.
* Having received as treatment techniques that involve needles on the previous 6 months to study enrollment, or having received percutaneous electrical stimulation as a treatment before.
* Cervical pathology, fibromyalgia, unstable cardiovascular diseases, pregnant women or under suspect of pregnancy.
* Contraindications of needle's insertions: anticoagulant therapy, needle phobia, diabetes, hypothyroidism, lymphoedema, muscular diseases).
* Contraindications of electrical current application.
Assessing Response to Treatment in Non-Hodgkin's Lymphoma Patients Using 64Cu-DOTA-Rituximab PET/CT

Rituximab is an antibody targeted against the CD20 antigen found primarily on B-cells. Therefore, an imaging agent targeting CD20 expression may provide a more accurate evaluation of extent of disease and response to therapy than the current standard of care, F-18 FDG PET/CT.

The main purpose of the study is to investigate a new PET/CT imaging probe for detection and follow up of lymphoma. Following are the 3 aims of the study: a) Phase I testing in lymphoma patients of Cu-64 labelled Rituxan for defining normal tracer biodistribution, stability, pharmacokinetics and radiation dosimetry; b) comparison of Cu-64 Rituxan and F-18 FDG PET/CT in lymphoma patients; c) evaluation of changes in uptake of Cu-64 Rituxan in response to rituximab-based treatment in CD20-positive B-cell NHL


Eligibility Criteria:
Inclusion Criteria:

* Patients must have a diagnosis of CD20-positive B-cell NHL and a staging 18F FDG PET/CT prior to the 64Cu-DOTA-Rituximab PET/CT
* Patients must understand and voluntarily sign an Informed Consent form after the contents have been fully explained to them
* Patients must be scheduled for rituximab-based therapy
* Patients must be older than 18-year-old

Exclusion Criteria:

* Patients who cannot complete a PET/CT scan
* Pregnant women
* Patients participating in other research protocols will be excluded from this study
The Role of Cytomegalovirus and Inflammation on Patient Symptoms and Outcomes in Ovarian Cancer

Cytomegalovirus (CMV), a widely prevalent virus in the general US population, has been shown to be associated with increased inflammation and mortality. Previous small pilot studies have demonstrated that latent CMV may be reactivated during chemotherapy in cancer patients, and may be associated with unfavorable cancer outcomes such as fatigue and increased mortality.

The central research idea for this study, supported by previous preliminary data, is that CMV reactivation is an unrecognized complicating factor in the treatment of ovarian cancer that impacts patient outcomes. The overarching goals of this observational study are:

* To assess how CMV infection is associated with ovarian cancer symptoms over the course of the disease and its treatment.
* To describe the relationship between CMV reactivation in ovarian cancer patients, survival, fatigue, and other QOL outcomes, both cross-sectionally and longitudinally.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18
* Ability to read and write in English
* women with newly diagnosed with ovarian, primary peritoneal, or fallopian tube cancer
* Treatment plan includes chemotherapy
* Able to provide written voluntary consent before performance of any study related procedure.
* Cohort 1 only: within 2 years of completing initial chemotherapy treatment
* Cohort 2 only: prior to starting chemotherapy

Exclusion Criteria:

* Inability to provide informed written consent
* Previous exposure to chemotherapy
* Life expectancy \< 3 months or in hospice care or nursing home
Clinical Study of Magnetic Resonance Imaging and Deep Learning of Joint Synovial Disease

Through the high-throughput feature extraction of magnetic resonance images, the deep learning prediction model of joint synovial lesions is constructed used for the diagnosis, differential diagnosis and curative effect monitoring of joint synovial lesions.

The study applies magnetic resonance and deep learning (DL) to the diagnosis of joint synovial lesions, aims to have a more comprehensive understanding of the pathophysiology of the occurrence and development of joint synovial lesions. As a non-invasive imaging method to assess the condition of the disease, DL methods excavates the deep features contained in the image, quantifies the joint synovial lesions, and then gives more information to the clinician in the diagnosis and differential diagnosis of the joint synovial lesions, provide important information for the planning of individualized treatment plans for patients with joint synovial diseases.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with joint synovial disease through radiological examination, arthroscopy or pathological biopsy of the joint, or whose clinical manifestations meet the diagnostic criteria of the American College of Rheumatology (ACR) for joint synovial disease.
2. Patients received pre-treatment MR.

Exclusion Criteria:

1. Patients who have received surgery, medication or other systemic treatment before standardized MRI scan.
2. Poor image quality.
3. Articular hemorrhage.
Ultrasound Guided - Incisionless Threaded Carpal Tunnel Release

The overarching long-term goal is to develop a CTS Treatment Center within the Hand Clinic that offers a variety of established and emerging treatment options in a multidisciplinary program. The ultra-minimally invasive carpal tunnel release would be one component of the program. Furthering the knowledge with regard to ultra-minimally invasive carpal tunnel release outcomes would facilitate the Hand Clinics ability to offer this procedure as a component of individualized care in the CTS Treatment Center to facilitate delivery of the appropriate level of care to the right patient.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of CTS with symptoms including pain, paresthesia's, and weakness of the hand in the median nerve distribution for minimum of 3 months
* Age 18-65 years old
* Persistence of symptoms after 6 weeks of conservative treatment such as splinting, activity modification, and/or injection therapy.
* Electromyographic evidence of mild, moderate, moderately severe, or severe median nerve neuropathy at the wrist
* Ability to complete all follow up appointments

Exclusion Criteria:

* Previous CTS surgical release on affected side
* Diabetes mellitus
* Hypothyroidism
* Hand arthritis (rheumatologic or osteoarthritis)
* Pregnancy
* Electromyographic evidence of any condition other than CTS affecting the hand
* Workman's compensation
* Participants not willing to make follow-up visits
Evaluating the Effect of Food on Absorption of Megace ES

To evaluate the effect of food on the rate and extent of absorption of megestrol acetate 625 mg/5 mL , and determine the safety and tolerability of megestrol acetate 625 mg/5 mL in healthy individuals.


Eligibility Criteria:
Inclusion Criteria:

* Body weight ranging from 60-100 kg (132-220 lbs) and body mass index ≥18 and ≤32
* Healthy

Exclusion Criteria:

* History of or any current medical conditions that could interfere with drug consumption, absorption, distribution, metabolism (eg. CYP450 inducers or inhibitors), or excretion of study drug
* History of or any current medical conditions that could affect subject safety
* History of frequent nausea or emesis, regardless of etiology
* Participation in a clinical drug study during the 30 days preceding the initial dose
* Significant illness during the 4 weeks preceding study entry
* Use of any medication, including vitamins/herbal/mineral supplements, during the 7 days preceding the initial dose
* Refusal or inability to abstain from food 10 hours proceeding and 4 hours following study drug administration, to consume the FDA high fat meal as directed, and to abstain from caffeine- or xanthine-containing beverages entirely during each confinement
* Any history of or current drug or alcohol abuse
* Prior alcohol intake exceeding the equivalent of 14 units/week (12 oz beer = 4 oz wine = 1.5 oz shot = 1 unit) on average, or consumption of any alcoholic beverages within 48 hours of study drug administration
* History of smoking\>25 cigarettes/day within 45 days of study drug administration
* Blood or blood products donated within 30 days prior to study drug administration, or anytime during the study, except as required by this protocol
* Positive results of urine drug screen, blood alcohol by a Breathalyzer test, hepatitis B surface antigen, hepatitis B surface antibody (unless immunized), or anti-HCV
Influence of Static Distal Locking of a Short Proximal Femoral Nail

Prospective, comparative, randomized, double-blind study to evaluate the outcomes of trochanteric nailing in unstable hip fractures with and without a distal interlocking screw.

Due to the lack of first-level evidence, this study aims to evaluate the effectiveness and safety of surgical treatment for unstable hip fractures, with or without the inclusion of a distal interlocking screw in the hip nail.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 50 years old
* With unstable intertrochanteric hip fracture
* Operated in the first 48 hours after hospital admission

Exclusion Criteria:

* Simultaneous associated fractures
* Fractures with subtrochanteric line
* Non-acute fractures
Observational Study of Musculoskeletal Patients in an Emergency Department in France

The purpose of this study is to estimate the number of patients who come to the emergency department with a musculoskeletal referral, to describe the different types of diagnosis for these patients and their treatment and discharge.

There is a crisis in the emergency department (ED) in France, as their number of consultations have constantly increased over the past ten years . Musculoskeletal disorders (MSK) are the most common cause of consultations in ED, as an example there is an average of 30% of ED consultations being for traumatic issues . Moreover, 90% of all patients coming in ED in France have a favourable prognosis of evolution (no risk of seriousness). In this situation, one of the propositions to help to reduce the ED burden is to allow a direct access to physiotherapists. They are the recommended profession to treat patients for musculoskeletal conditions and several studies showed physiotherapy assessment and treatment in an emergency service is safe and beneficial both for the patients and the hospital teams. They have reported to increase satisfaction, to reduce medications and requirement for expensive imaging on one hand, and to reduce the costs and to give more time to the medical team on the other hand This role does not exist yet in France, although more than 48 countries across the world have implemented it, and French physiotherapists are advocating for it. A recent text has been adopted by the French government allowing patients with recent ankle sprain or low back pain to self-refer to physiotherapists working in hospitals or in care home. . However, this access is very restricted, which will make the implementation difficult as it might not be sufficient to assist the ED. Moreover, there is a lack of information on the number and the type of diagnostic of patients with a MSK label coming to the ED, which makes it difficult to assess the impact this role could have on French ED.

In this context, a retrospective survey, describing how many patients with a musculoskeletal label are coming to the ED, and how they are managed, could help to estimate the worthiness of physiotherapist direct access in French ED.

Question : What is the proportion, the type of diagnostic and the management of musculoskeletal disorder in emergency department in one hospital in France?

Eligibility Criteria:
Inclusion Criteria :

* Patients aged between 18 and 68
* Patients admitted to emergency with a triage by the Reception and Referral Nurse of 0, 1 or 2
* Patients who consulted for one of the following reasons:

Lower limb pain (T13.9) Lower limb trauma (M79.61) Upper limb pain (T11.9) Upper limb trauma (M79.60) Spinal pain (M54.9) Lumbar or flank pain (R10.3) Diffuse/unspecific pain (R52.9) Loss of sensitivity/paraesthesia

- Patients informed of the study and who did not object

Exclusion Criteria :

* Patients with another reason for consultation associated with the first
* Patients under guardianship / curatorship and patients under safeguard of justice.