cyrilzakka/clinical-trials huggingface dataset:
A 52-Week Study of Bicifadine in Patients With Chronic Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

This study is to evaluate the long-term efficacy and safety of two dosages of bicifadine SR (600 mg/day and 1200 mg/day) for up to 52 weeks in reducing chronic peripheral neuropathy pain due to diabetes in adult outpatients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* 18 years or older
* Diagnosis of type 1 or type 2 non-insulin dependent diabetes mellitus
* Chronic bilateral pain due to diabetic neuropathy, pain for at least six months.
* Primary pain is located in the feet.
* Subject participated in and completed the XTL 07-001 clinical trial.

Contact site for additional information.

Exclusion Criteria:

* Symptoms of other painful conditions
* Presence of amputations other than toes
* Clinically significant psychiatric or other neuropsychological disorder
* Use of certain medications
* Clinically important other diseases
* Pregnancy
* History of alcohol or narcotic abuse within two years.

Contact site for additional information.
Maxera Large Cups - Canada

This study is monocentric, retrospective and prospective, non-controlled, consecutive series Post-Market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Largest Zimmer® Maxera™ Cup (Implants and Instrumentation)

The Zimmer Maxera Cup is a monoblock construct that consists of a preassembled shell and liner. The ceramic liner articulates with a ceramic femoral head for a ceramic-on-ceramic large diameter head articulation.

The BIOLOX® delta ceramic liner (insert) is preassembled to lock into the tapered shell's cavity and articulate with BIOLOX OPTION ceramic femoral heads, sizes 32, 36, 40, 44, and 48 mm and standard BIOLOX delta ceramic femoral head sizes 32, 36, and 40 mm.

This is a single center post-market clinical evaluation. A consecutive series of 32 patients treated with a Maxera Cup (outer diameter 64 mm or 66 mm) between Nov 2011 and Feb 2018 will be identified and invited to participate in the study.

Eligibility Criteria:
Inclusion Criteria:

* Patient received a Maxera Cup with an outer diameter of 64 mm or 66 mm.
* The Zimmer Maxera Cup is indicated for non-cemented use in skeletally mature individuals undergoing primary surgery for rehabilitating hips damaged as a result of non-inflammatory degenerative joint disease (NIDJD) including but not limited to osteoarthritis, avascular necrosis, post-traumatic arthritis, congenital hip dysplasia, and inflammatory joint disease (IJD), e.g. rheumatoid arthritis if bone quality is adequate.

Exclusion Criteria:

* Active, old, or remote infection of the hip.
* Osteoradionecrosis.
* Local bone tumors and/or cysts.
* Patients with poor bone quality, where there is inadequate bone to support the implant(s).
* Neuromuscular compromise, vascular deficiency or other conditions in the affected limb that may lead to inadequate skeletal fixation.
* Allergy to the implanted material.
* Patient's physical conditions that would eliminate or tend to eliminate adequate implant support or prevent the use of an appropriately sized implant, e.g. previous surgery, insufficient quality or quantity of bone resulting from conditions such as cancer or congenital dislocation, metabolic bone disease of the upper femur or pelvis, femoral osteotomy revision, girdle stone revision, osteoporosis, osteomyelitis, neuromuscular compromise or vascular deficiency in the affected limb in sufficient degree to render the procedure unjustifiable (e.g. absence of musculoligamentous supporting structures, joint neuropathy) or other conditions that may lead to inadequate skeletal fixation
* Do not use ceramic femoral heads which are not BIOLOX delta or BIOLOX OPTION with Maxera components.
* Use of this device when a less invasive procedure would be sufficient.
* Skeletal immaturity.
* Any nerve or muscle disease that may have a negative effect on gait or weight bearing
* Loss of abductor musculature in the affected limb.
* Poor skin coverage around the hip joint.
* Rapid disease progression as obvious by joint destruction or bone absorption seen on x-ray.
A Randomized, Double Blind, Placebo Controlled Trial L-carnitine and Piracetam in the Treatment of Weakness, Muscle Fatigue and Muscle Pain in the Postpoliomyelitis Syndrome

This protocol aims to assess of L-carnitine and piracetam to relieve weakness, muscle fatigue and muscle pain in patients with Postpoliomyelitis Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Postpoliomyelitis Syndrome diagnosis confirmed over a year;
* Electromyography test compatible with poliomyelitis;
* Preserved ability to swallow medication;
* Oral communication ability preserved;
* Preserved ability to perform pedaling test in at least one lower limb affected by Postpoliomyelitis Syndrome;
* Ability to understand information about the study and to document the decision about participating in the trial by signing the Informed Consent Form.

Exclusion Criteria:

* History of intolerance to L-carnitine or piracetam;
* Treatment with L-carnitine during the past 3 months;
* Treatment with piracetam or any other nootropics pyrrolidone derivatives, during the past three months;
* Anemia (hemoglobin reference range - men 13 to 17 g/dL and women 12 to 15 g/dL);
* High level of glycated hemoglobin (\> 7.0%);
* Electrolyte imbalance (hypokalaemia - reference potassium concentration range: 3.5 to 5.6 mmol / L);
* Renal failure (creatinine reference range: 0.70 to 1.50 mg/dL);
* Urinary tract infection;
* Thyroid dysfunction (reference range: free T4: 0.54 to 0.67 mg/dL and TSH reference range: 0.5 to 5.5 μUI/mL) or usual treatment with thyroid hormone supplementation;
* Cardiomyopathy;
* Uncontrolled hypertension;
* Known or suspected autoimmune disease;
* Confirmed pregnancy, or plans to get pregnant during the trial;
* Depression or bipolar affective disorders with moderate to severe episodes within the last twelve months;
* Insulin-dependent diabetes mellitus;
* Treatment with anticoagulant drugs over two weeks (including non-steroidal anti-inflammatory drugs (NSAIDs), warfarin, phenprocoumon, heparin);
* Usual cocaine or alcohol use;
* Any other condition judged by the investigator as a possibility to interfere on the participant's decision to be part of the study or to accomplish investigation procedures.
High Tone Therapy for Chemotherapy Induced Neuropathy

Chemotherapy-induced peripheral neuropathy (CIPN), a side effect of antineoplastic medication, was reported to occur in about 68% of the patients receiving chemotherapy. CIPN does not only limit quality of life due to neuropathic symptoms but also may lead to dose reductions or premature interruption of therapy and thus to suboptimal cancer treatment.

Patients with neuropathy suffer from sensory disturbances as tingling, numbness, burning pain or sleep disturbances and even though numerous drugs are available, it is still difficult to sufficiently control these Symptoms.

High tone therapy / high tone external muscle stimulation (HTEMS) seems to be an effective treatment for neuropathic symptoms. Previous studies observed promising results in diabetics and chronic kidney disease (CKD) patients.

To date, there is no investigation on HTEMS in patients with chemotherapy induced neuropathy.

Therefore, this aim of this project is to test if HTEMS would bring about a stronger decrease in neuropathic symptoms in this specific patient group, compared to a placebo treatment.

The primary objective is the alleviation of paresthesias. The secondary objective focuses on detailed symptoms of neuropathiy as well as on health-related quality of life.


Eligibility Criteria:
Inclusion criteria:

* Patients with histologically verified colorectal cancer and adjuvant treatment with a platin derivate (e.g., cisplatin, oxaliplatin): This group was chosen due to relatively high risk of neuropathy due to this special therapeutic agent 1,9.
* Cumulative dose of at least 3 cycles
* Interval of 2 weeks since the last chemotherapeutic cycle in order to prevent false worsenings due to delayed neurotoxic effects
* Life expectancy of at least 3 months
* Stable medication (no changes of especially pain medication during the study)
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2 (that is, the capability to walk and to spend less than 50% of waking hours sitting or lying)
* Ability to walk (with or without aids)
* European Organisation for Research and Treatment of Cancer (EORTC) common toxicity criteria (CTC) peripheral sensory neuropathy grade 1 or 2
* Intensity of paresthesias of 3/10 or higher on the Numeric Rating Scale (NRS)

Exclusion criteria:

* Prevalent neuropathy of different etiology
* Serious central-neurological or psychiatric disorder that would interfer with a proper order of the study, according to the judgement of the investigators
* Epilepsy
* Minors or persons unable to give informed consent
* Current neurotoxic medication
* Implanted pacemakers or defibrillators
* Pregnancy
* Wounds in the area to be treated, acute local or systemic infection
* Peripheral arterial occlusive disease \> grade 2
Use of a Family Navigator in Families With Children Newly Diagnosed With Autism Spectrum Disorder

The purpose of this study is to see whether or not Family Navigators, who 1 ) help families after their child is diagnosed with autism and help them get autism specific services for their child 2) help families identify barriers to obtaining these services and 3) help families problem solve to overcome these barrier, are helpful to parents of a child newly diagnosed with an Autism Spectrum Disorder.


Eligibility Criteria:
Inclusion Criteria:

* Child with a new confirmed diagnosis of Autism Spectrum Disorder
* Child is under 8 years of age
* Parent is the mother, father and/or legal guardian of the child and identifies themselves as the primary caregiver
* Primary caregiver speaks English, Spanish, Haitian Creole, Somali, Vietnamese, Portuguese or Chinese

Exclusion Criteria:

* Parent or legal guardian has psychosis
* Parent or legal guardian endorses suicidal ideation
* Parent or legal guardian actively using illicit drugs
* Parent or legal guardian expected to leave area within 6 months
Auris Robotic Endoscopy System for Bronchoscopy

In this study, the performance related to the use of the novel Robotic Endoscopy Platform during bronchoscopic procedures will be evaluated.

The early and accurate diagnosis of lung cancer is critical. However, many peripheral lung lesions are beyond the reach of conventional bronchoscopes. Additionally, alternative techniques, such as CT-guided or surgical biopsy, can carry increased risks to the patient. Diagnostic yield of flexible bronchoscopy is limited by its inability to guide biopsy instruments directly to the lesion. Varying technologies have been proposed to guide endobronchial biopsies, such as electromagnetic navigation, endobronchial ultrasound (EBUS) and computed tomography fluoroscopy. However, the correlation of real-time guidance and the ability to precisely direct a biopsy instrument is critical to biopsy success.

In this study , the novel Robotic Endoscopy Platform and its accessories will be used to provide bronchoscopic visualization of and access to patient airways for diagnostic procedures. Commercially available biopsy instruments will be used to acquire tissue for diagnostic purposes.

Eligibility Criteria:
Inclusion Criteria:

1. 18 to 80 years of age;
2. Capable and willing to give informed consent;
3. Acceptable candidate for an elective, non-emergent bronchoscopic procedure;
4. Solid peripheral lung lesions suspected of malignancy, between 1.5-7cm in size identified on thin slice CT scan with 30 days of the intended bronchoscopy

Exclusion Criteria:

1. Medical contraindication to bronchoscopy;
2. Ground glass opacity lesions on pre-procedure CT
3. Participation in any other clinical trial 30 days before and throughout the duration of the study;
4. Uncontrolled or irreversible coagulopathy;
5. Female subjects who are pregnant or nursing or those of child-bearing potential refusing a pregnancy test;
6. CT scan done over a month before the bronchoscopy procedure.

Intra-Procedure Exclusion Criteria: Any presenting condition discovered intra-procedurally that in the opinion of the investigator would make participating in this study not in the patient's best interest.
Physical Activity Program and Nutrition Therapeutic Education During Treatment of Head and Neck Cancer Population

The purpose of this study is to examine the feasibility of resistance training and physical functioning associated with nutrition therapeutic education in head and neck cancer patients, during their treatment (chemotherapy with or without radiotherapy).

The loss of muscle mass (i.e., sarcopenia) has been identified as a negative prognosis descriptor, disregarding the type of cancer. It is also a predictive descriptor for treatment-related toxicity. Therefore it appears crucial to save muscle mass of patients, following an adequate physical training together with a personalised diet program. The latter point is of major importance as malnutrition concerns 45% patients having head and neck cancer cancer, who stop physical activity due to extreme tiredness and decrease of quality of life. In the present project, we plan a physical activity program that would be adapted to each patient, accompanied by the rethought diet over a 3-month period. The adapted physical activity (APA) is constituted of two aerobic stages and one resistance training stage per a week. The evaluation will then proceed at three different moments, namely (i) at T0 i.e., beginning of the program, (ii) at 3 months i.e., when the program will be stopped, and (iii) at 6 months i.e., three months after the program stop. This evaluation will include the success rate, the level of satisfaction, the physiological parameters (VO2max, muscle mass and strength, BMI) and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years
* Written informed consent provided before any study specific procedures
* Consent to cooperate for clinical assessments
* Affiliation to a social security regime or beneficiary of equivalent social protection
* Performance status between 0 and 2
* Squamous cell carcinoma of oral cavity, oropharynx or hypopharynx
* Stage III - IV (T1-T4, N0-N3, M)(UICC 2002)
* Indication of radiotherapy and chemotherapy post-operative or first-line metastatic chemotherapy or in inoperable condition
* Ability to understand the nature, goal and study methodology

Exclusion Criteria:

* Prior neoadjuvant chemotherapy
* timed vital capacity\< 70%
* Presence of another severe pathology including:
* severe or chronic cardiac, pulmonary, renal and/or hepatic insufficiencies
* Cons-indication to physical activity practice, at discretion of the investigator
* Patient under guardianship
* Psychological, social, geographical, or familial reasons prohibiting physical activity and follow-up
* Any other primary tumor during the last 5 years
* Pregnant or nursing
Management of the Patient at High Risk Hemorrhagic in Cardiac Surgery by Monitoring Viscoelastic Hemostasis.

Evaluation and following of a protocol using viscoelastic test for the management of high risk patients in cardiac surgery

Haemorragy is a frequent issue in cardiac surgery due to multiple contributing factors. Excessive bleeding as well as transfusion are associated with increased morbidity and mortality.

Haemostatic blood products (Fibrinogen, fresh frozen plasma, platelets) transfusion had historically been guided by routine coagulation tests (aPTT, PT, platelets and fibrinogen). However, the delay (Up to 60 minutes) often leads to an empirical use of blood products in a context where clinical judgment is unreliable due to the multiples mechanisms contributing to haemostatic failure.

Using viscoelastic tests (VET) in this context has several advantages :

* A quicker response (with first results from 10 minutes)
* An overall evaluation of haemostatic from the clot formation to its dissolution.

The use of VET has mainly been evaluated in cardiac surgery, with several recent meta-analysis : The use of transfusion algorithms based on VET is associated with less transfusions of red blood cell concentrates, plasma and platelets and also with less mortality, less re-interventions due to excessive bleeding and less post operative renal failure.

These data led the international society for the study of hemostasis and thrombosis (ISTH) to recommend their use of VET in cardiac surgery. In France, the proposals of the peri operative hemostatis group of interest (GIHP) also support their use, specifying that there is no unique consensual algorithm.

Considering this, the investigator established a transfusion algorithm based on the Quantra, a viscoelastic device using sonorrheometry, to guide transfusion in high-risk of bleeding cardiac surgery patients.

Eligibility Criteria:
Inclusion Criteria :

* Adult patients
* Elective or non-elective high risk of bleeding heart surgery
* Non-opposition

Exclusion Criteria:

* Pregnant women
* Age \< 18 years
* Patients under guardianship
* Opposition
Evaluation of the Effect of Duration of Stabilising Tapes on Skin Damage in Neonates

The research was conducted to evaluate the relationship between the duration of the fixing tapes of the probes attached to the chest, abdominal and lower extremity regions of newborns for temperature monitoring and skin damage.

Aim: The research was conducted to evaluate the relationship between the duration of the fixing tapes of the probes attached to the chest, abdominal and lower extremity regions of newborns for temperature monitoring and skin damage.

Materials and Methods: The research was conducted in a randomized controlled experimental design between August 2023 and December 2023. The 37th-40th year is being treated in the Neonatal Intensive Care Unit of Gynecology Training and Research Hospital. It was done with 60 newborns between weeks. Newborns were assigned to the experimental group (n = 30) and control group (n = 30) by simple randomization. In the experimental group, the duration of the fixative tapes to stay on the skin was 2 hours, and in the control group, the duration of the fixative tapes to stay on the skin was 4 hours, which is applied in the clinical routine. Stabilizer tapes were adhered to three different areas on the skin and changed clockwise. Data were collected using the Newborn Information Form, Newborn Skin Condition Assessment Scale (NSCS) and Newborn Skin Risk Assessment Scale (NSRAS). Descriptive statistics, repeated measures ANOVA, Pearson Correlation test and Pearson Chi Square test statistics were used in data analysis. p\<0.05 level was considered statistically significant.

Key Words: Newborn, Skin Damage, Epidermis, Stabilization Tapes, Newborn Nurse

Eligibility Criteria:
Inclusion Criteria:

* Newborns between 37th and 40th week
* Use of a temperature monitoring probe
* Parents volunteering their infants to participate in the study and signing the consent form

Exclusion Criteria:

* Presence of conditions that may make skin condition assessment difficult (presence of any laceration, fracture or genetic dermatological disease that disrupts skin integrity, congenital skin damage, hydrops, anomalies of the anterior abdominal wall, scleroderma)
* Parents not volunteering for the study
Better Life by Nutrition During Adulthood

BELINDA is a follow'up of subjects included 10 years ago in HELENA study which was a cross-sectional study carried out from 2006 to 2007 in more than 3500 adolescents aged from 12.5 to 17.5 years old through 10 Europeans towns from 9 countries.

BELINDA main objective is to assess CV risk using PDAY score (Pathobiological Determinants of Atherosclerosis in Youth) during young adulthood (20 to 31 years) and analyze lifestyle risk factors from adolescence (12 to 18 years). This analyze may define new CV risk factors and risk population cluster.

BELINDA subjects from Lille, Ghent , Zaragoza and Roma will be re-tested using a part of HELENA test battery and some new evaluation criteria.

Eligibility Criteria:
Inclusion Criteria:

* Women of men participating to HELENA study 2006-2007
* Aged from 20 to 35 years.
* Signed informed consent

Exclusion Criteria:

* Pregnant or lactating women
Effect of Quercetin on Prophylaxis and Treatment of COVID-19

Novel Coronavirus is defined to be the cause of COVID-19, recently. It's known that COVID-19 goes with excessive immune reaction of human body in severe cases. The investigators hypothesize that quercetin, as a strong scavenger and anti-inflammatory agent, can be effective on both prophylaxis and treatment of COVID-19 cases. Therefore, the aim of this study to evaluate the possible role of quercetin on prophylaxis and treatment of COVID-19.

Novel Coronavirus is defined to be the cause of COVID-19, recently. It's known that COVID-19 goes with excessive immune reaction of human body in severe cases. Quercetin is reported to be effective on treatment and prophylaxis of other SARS like coronavirus infections, as a strong antioxidant and scavenger flavonoid without any adverse events. Upon this data, the investigators hypothesize that quercetin can be effective on both prophylaxis and treatment of COVID-19 cases. Therefore, the aim of this study to evaluate the possible role of quercetin on prophylaxis and treatment of COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* moderate-high risk for COVID-19
* obtained informed consent

Exclusion Criteria:

* declined to participate
* genetic/chromosomal abnormalities
* any kind of sensitivity or allergy for quercetin
* history of previous hypersensitivity with quercetin
Narrowband UVB Treatment in Patients With Vitiligo

The study offers narrowband UVB light therapy to patients who have 5% of their body involved with vitiligo.

The hypothesis is that Narrowband UVB promotes melanocyte proliferation in vitiligo lesions.

All patients will receive phototherapy, with narrowband UVB, three times a week for six months, or a total of 78 treatments. 6mm punch skin biopsies (2) will be done prior to starting therapy, once during treatment (2) and at the completion of the study (2). Clinical assessments and photography will be done parallel to the skin biopsies. Results (clinically and histologically) will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years of age or greater
* Vitiligo with extensive skin involvement (\>5% body surface affected).

Exclusion Criteria:

* No treatment with topical steroids, calcineurin inhibitors or vitamin D analogs for at least 4 weeks prior to entering the study.
* No treatment with systemic therapies, including methotrexate, etretinate, PUVA, or cyclosporine 4 weeks prior to entering the study.