cyrilzakka/clinical-trials huggingface dataset:
Study of NMDA Antagonists and Neuropathic Pain

The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity.

In clinical, after ketamine cure, clinicians have often difficulties to treat patients in order to maintain analgesia or suggest another treatment if analgesia induced by ketamine was not effective, which occurs in one quarter of patients. It will be very useful for monitoring of painful patients evaluate if memantine or dextromethorphan could be an effective therapeutic alternative in neuropathic pain treatment.

The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity.

In clinical, after ketamine cure, clinicians have often difficulties to treat patients in order to maintain analgesia or suggest another treatment if analgesia induced by ketamine was not effective, which occurs in one quarter of patients. It will be very useful for monitoring of painful patients evaluate if memantine or dextromethorphan could be an effective therapeutic alternative in neuropathic pain treatment.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old
* patient suffering chronic neuropathic pain
* All chronic pain is retained except central or diabetic pain
* Answering patient at ketamine in pain treatment by investigator, and having already received ketamine
* Patient who completed before ketamine the following evaluation :

DN4, QCD, QDSA, PGIC questionnaires, HAD scale, Leed's sleep evaluation and SF36.

* Patient who completed at the end of treatment the following evaluation : numerical scale and PGIC
* Sufficient cooperation and understanding to comply to the requirements of study
* Acceptance to give a written concert
* Affiliation at system of French social security
* Inscription or acceptation of inscription at national register of voluntaries participant at research

Exclusion Criteria:

* Against-indication at memantine or dextromethorphan administration : hypersensitivity at active substance or excipients, hypertension, antecedent cerebrovascular accident, severe cardiac insufficiency
* Patient with medical or surgical antecedents
* Patient with progressive disease at balance of inclusion
* Patient treated by an IMAO
* Woman in childbearing age not using effective contraceptive method, pregnant or lactating woman
* Patient who participated in another clinical trial, located in exclusion period or received benefits \> 4500 euros during 12 months before the beginning of trial
* Patient with cooperation and understanding insufficiency to comply to the requirements of protocol
* Patient with social protection
* No affiliation at system of French social security
Persistent Readiness Through Early Prediction Immunization Study

This study will enroll volunteers in an open-format (outside hospital) setting, to complete novel data collection/analysis of biomarkers, facial images, and audio-recording to establish an optimal set of parameters to predict emergent cases of infection via an early warning score, along with actionable personalized information.

The objective of the study is to collect data from participants for a period of 4 weeks. These data will be used for developing and testing an algorithm for early detection of infection.

At the end of week two, subjects will receive an immunization in a double-blind randomized placebo-controlled fashion. Vaccines to be administered will be pneumococcal (PPSV23), typhoid (inactivated), or saline. Administration of these vaccines often cause mild 'infection-like' inflammation response. Pneumococcal infection causes pneumonia and can lead to sepsis and the PPSV23 vaccination will induce mild symptoms related to the immune system activation including local reaction in 50% of the cases and fever and malaise in 1% of the cases. Typhoid fever is caused by salmonella Typhi bacteria and its effects can range from gastrointestinal symptoms to sepsis. Injectable typhoid vaccine (inactivated) side effects will induce mild symptoms related to the immune system activation and can include local reaction in 6% of the cases and fever, malaise, headache and sometimes diarrhea in 1% of the cases.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-40 (inclusive)
* Subject is judged to be in satisfactory health based on medical history, physical examination
* Ability to walk, sit down and stand up independently
* Willingness and ability to comply with the protocol
* ownership and use of smartphone
* ownership and use of laptop

Exclusion Criteria:

* Subject has planned elective surgery requiring 2 or more days of hospitalization during the entire study
* Active dependence of alcohol or drugs (self-reported)
* Known allergy to any of the following:
* Components of the vaccine/placebo
* Diagnosed and active treatment of chronic disease:
* Diabetes (Type 1 or 2)
* Active malignancy
* Heart disease
* Kidney disease
* Liver disease
* HIV/AIDS
* Hepatitis A, B, or C
* Asthma (moderate to severe)
* (possible/desire to be) pregnancy (confirmed via urine pregnancy test)
* Subject is currently enrolled in a study with an investigational compound or device
* Subject has already received the pneumococcal (PPSV23) vaccine
* Subject has already received the typhoid (inactivated) vaccine
* Subject has received any other investigational vaccination within 4 weeks of enrollment
* Any other condition that interfere with the definition 'healthy" based on self-report and according to the PI/study physician's judgement based on medical history, use of medication, and physical exam.
Use of Accessory Device AmplifEYE During Average Risk Screening Colonoscopy to Increase Adenoma Detection Rate

The purpose of this investigator-initiated study is to determine whether the use of an accessory device called AmplifEYE can improve colonoscopy quality in patients who are undergoing average risk colorectal cancer screening. Primary end point is adenoma detection rates.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients greater than or at 50 years of age who are referred for average risk screening colonoscopy.

Exclusion Criteria:

* Any pregnant patient
* Patient's that are unable to provide consent for themselves
* Any patient undergoing diagnostic colonoscopy (IBD, rectal bleeding, recent change in bowel habits, etc.)
* Any patient undergoing surveillance (prior history of polyps or colorectal cancer)
* Any patient undergoing high risk screening colonoscopy (family history of colon cancer in first degree family member \<65 years of age, or co-existing conditions that pre-dispose to colon cancer such as polyposis syndromes, PSC or IBD)
* Prior history of any cancer
* Current or past immunosuppression (due to either infection or medications)
* Coagulation disorder OR use of anti-coagulation or anti-platelet therapy other than aspirin within 5-7 days of procedure
* Colonic strictures
* suspected intestinal obstruction or colonic pseudo-obstruction
* history of colon resection
* active infection
* active inflammation (including diverticulitis)
Pharmacokinetic Study of Iron Isomaltoside 1000 Administered by 250 mg IV Bolus Injection or 500 mg Intravenous Infusion to Patients With Non-hematological Malignancies Associated With Chemotherapy Induced Anaemia

The purpose of this study is to assess Pharmakokinetic properties of iron isomaltoside 1000 (Monofer®) in doses of 250 mg and 500 mg in patients suffering from Chemotherapy Induced anemia.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women, aged more than 18 years.
2. Weight above 50 kg.
3. Subjects diagnosed with non-hematological malignancies (solid tumors only) receiving chemotherapy at least 1 day prior to screening and who are going to receive at least two more chemotherapy cycles.
4. Hb \< 12 g/dL.
5. TfS \<20%.
6. Serum Ferritin \<800 ng/ml.
7. An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
8. Willingness to participate after informed consent.

Exclusion Criteria:

1. Anaemia caused primarily by other factors than CIA.
2. IV or oral iron treatment within 4 weeks prior to screening visit.
3. Erythropoietin treatment within 4 weeks prior to screening visit.
4. Blood transfusion within 4 weeks prior to screening visit.
5. Imminent expectation of blood transfusion on part of treating physician.
6. Iron overload or disturbances in utilization of iron (e.g. haemochromatosis and haemosiderosis).
7. Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes).
8. Known hypersensitivity to any excipients in the investigational drug products.
9. Subjects with a history of multiple allergies.
10. Decompensated liver cirrhosis and hepatitis (alanine aminotransferase (ALAT) \> 3 times upper normal limit).
11. History of Immunocompromise and/or history of Hepatitis B and/or C.
12. Active acute or chronic infections (assessed by clinical judgement and if deemed necessary by investigator supplied with white blood cells (WBC) and C-reactive protein (CRP)).
13. Rheumatoid arthritis with symptoms or signs of active joint inflammation.
14. Pregnant or breast feeding women.
15. Women of child bearing potential who are not using safe contraceptive methods (e.g. intrauterine device, oral contraceptives or surgically sterilized) or who are planning to become pregnant within the study period.
16. Planned elective surgery during the study.
17. Participation in any other clinical study (except chemotherapy protocol) within 3 months prior to screening.
18. Untreated B12 or folate deficiency.
19. Any other medical condition that, in the opinion of Principal Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study. Example, Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus.
Comparison of Retention of Self-etch Sealants and Flowable Composite in Permanent Molars

Comparison of Retention of Self-etch sealants and Flowable Composite in permanent Molars.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged between 8 to 18 years.
2. Patients with completely erupted maxillary and mandibular molars with deep pits and fissures having a score of 0 or 1 according to ICDAS classification -

Exclusion Criteria:

1. Patients with a history of any medical conditions such as Sjogren's syndrome , renal failure or have immunocompromised state (juvenile diabetes).
2. Patients with history of prolonged medication such as steroids, chemotherapy or TB medication.
3. Teeth with carious lesion extending to dentino-enamel junction/dentin.
4. Patients with poor oral hygiene.
5. Patients with bruxism or parafunctional habits.
6. Permanent molars with developmental defects or restorations.
7. Teeth with poor prognosis and having periodontal diseases.
Castleman Disease Collaborative Network Biobank

The purpose of this study is to create a biobank, which collects, stores, and distributes samples of human tissues, blood, and related health information to qualified scientists, in order to help doctors and researchers better understand why Castleman Disease occurs and develop ways to better treat and prevent it.

The CDCN proposes to establish a biobank and associated clinical data for Castleman disease. Tissue and fluid (blood and saliva) samples will be collected both prospectively and retrospectively. Blood or saliva samples may also be collected from relatives of Castleman patients. Because of the scarcity of these samples, it will be necessary to make efforts to access all available cases. Many cases will occur at hospitals that do not have an existing relationship with the CDCN and may not have experience with tissue procurement; however, this is the only way to obtain the vast majority of samples. Samples may be used immediately, banked for future use, or further processed into DNA, cell lines, tissue microarrays, etc.

The samples will be stored at Precision for Medicine, a biorepository company that specializes in collection, processing, storage and distribution of biospecimens. Only researchers (US or international) who have applied to the CDCN and have been approved by the Biobank Advisory Board will be eligible to access biospecimens and/or data. The Biobank Advisory Board will be comprised of clinicians and scientists with experience in clinical and investigational practices in Castleman Disease.

Eligibility Criteria:
Inclusion Criteria

* Potential study participants may be of any age, gender, or ethnicity who have been diagnosed with Castleman disease

Exclusion Criteria

* None
Fatty Acids and Attention Deficit and Hyperactivity Disorder Symptoms

This study aimed to evaluate the longitudinal association between n-6:n-3 LCPUFAs ratio in cord blood and child ADHD symptoms at 4 and 7 years old. This study was based on the INMA project, a population-based birth cohort in Spain. Higher cord blood n-6:n-3 ratio was associated with higher subclinical ADHD symptoms during early and mid-childhood.


Eligibility Criteria:
Inclusion criteria:

* Age 16 years or older
* Singleton pregnancy
* No use of assisted reproductive techniques
* Intention to deliver at the reference hospital
* Ability to speak and understand Spanish or a local language
CBCT Vs OPT on the Oral Health Status At 12 Months of Patients Hospitalized for Infective Endocarditis.

1. Infective Endocarditis (IE) is a rare and serious disease with high morbidity and mortality; 2. Streptoccoci of oral origin are the second more frequent microorganisms responsible for IE; 3. Oral Infectious Foci (OIF) are underdetected using the current recommended clinical examination/Orthopantomogram (OPT) approach; 4. Cone Beam Computed Tomography (CBCT) has a better sensitivity and sensibility to detect OIF than OPT; 5. To date, no study has been performed to assess the potential benefit of a clinical examination/CBCT approach on the oral health status in IE patients.

Thus, conducting a randomized controlled trial is highly desirable to assess the potential impact of a clinical examination/CBCT approach on the oral health status of patients hospitalized for IE and potentially to reduce IE new episodes.


Eligibility Criteria:
Inclusion Criteria:

1. Patients hospitalized for definite IE according to the 2015 ESC classification, whatever the IE responsible microorganism;
2. Patients with a stable clinical state compatible with the performance of an OPT and a CBCT during his/her initial hospitalization for acute IE management;
3. Patients whose life expectancy is expected to be longer than 6 months;
4. Patients who agree to visit the dental department of the hospital to carry out OIF eradication or at his/her personal dentist;
5. Patients over 18 years old;
6. Patients affiliated to a Social Security or a health insurance scheme;
7. Patients who have given informed consent to participate to the study.

Exclusion Criteria:

1. OPT or CBCT already performed before the inclusion of the patients in the study and available for the investigator during the patient's hospitalization.
2. Medical contraindications to perform OPT or CBCT imaging;
3. Absence of microbiologic identification of the IE responsible microorganism;
4. Pregnant or breastfeeding women;
5. Patients unable to give informed consent to participate to the study (under trusteeship, guardianship and legal protection).
ROTATEQ Reexamination Study (V260-037)

This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of Rotateq through collecting the safety information according to the Re-examination Regulation for New Drugs.


Eligibility Criteria:
Inclusion Criteria:

* Infants Who Are Vaccinated With Rotateq For The Prevention Of Rotavirus Gastroenteritis Within Local Labeling Will Be Included

Exclusion Criteria:

* Participants who are vaccinated with Rotateq before study start
* Participant who has a contraindication to Rotateq according to the local label
An Explorative Randomized Controlled Investigation Evaluating Newly Developed Ostomy Products

The primary objective of the investigation is to explore the acceptance of a newly developed adhesive.


Eligibility Criteria:
Inclusion Criteria:

* Have given written informed consent and letter of authority
* Be at least 18 years of age and have full legal capacity
* Be able to handle the products her/himself
* Have an ileostomy with a diameter between 10 and 30 mm
* Willing to follow the product change schedule (one change per day)
* Have had their ostomy for at least three months
* Willing to use 1 piece open ostomy products during the test period
* Must be able to use a custom cut product
* Have intact skin
* Negative result of a pregnancy test for women of childbearing age

Exclusion Criteria:

* Currently receiving or have within the past 2 months received radio- and/or chemotherapy
* Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/ injection) treatment
* Is pregnant or breastfeeding.
* Is participating in other interventional clinical investigations or have previously participated in this investigation
* Have a loop ileostomy
* Known hypersensitivity towards any of the test products
Nordic Hamstring and Repeated-sprint Ability in Football (Soccer) Players

The purpose of the study is to investigate the efficacy of a 10-week intervention, using the Nordic Hamstring exercise, on repeated-sprint ability in male sub-elite football players. The primary outcome measure is total sprint time during 4x6 sprint of 10 meters measured using dual-beam photoelectric cells. Additionally, eccentric knee flexor strength is measured using the Nordbord hamstring strength measure. The hypothesis is that strength training of the knee flexor muscles elicited by the Nordic Hamstring exercise will result in enhanced repetitive sprint-ability expressed as a decrease in total sprint time. Furthermore, baseline data is used to assess to correlation between eccentric hamstring strength and active hamstring flexibility AND sprint performance.


Eligibility Criteria:
Inclusion Criteria:

* Sub-elite Danish football player
* Age 17-35.
* Able to participate fully in competitive football activities at the time of testing

Exclusion Criteria:

* Hamstring pain resulting in loss of training and matches 2 months prior to study initiation.
* Specific systematic strength training of the hamstring muscles (\>1/week) in the preceding 2 months before study initiation.
* Specific systematic sprint training (\>1/week) in the preceding 2 months before study initiation.
* Longstanding injury (\>6 weeks) in the lower extremities in the preceding 6 months to study initiation.
A Study Of Gastrointestinal Tolerability Of PF05212389 In Obese Subjects

This study examines whether a gradual increase of dose improves the gastrointestinal tolerability (nausea and vomiting) of PF05212389


Eligibility Criteria:
Inclusion Criteria:

Obesity

Exclusion Criteria:

Diabetes mellitus (type 1 or type 2) Heart failure Eating disorders Psychiatric disorders History of suicide attempt History of pancreatitis
Cleft Palate Surgery and Speech Development

Compare the outcome of two primary surgeries techniques (von Langenbeck and Furlow double z-plasty) performed on children with cleft lip/palate to determine if one results in significantly better velopharyngeal competency for speech.

This study is conducted with patients with complete unilateral cleft lip and palate. The subjects will have their palatal clefts surgically repaired by either the von Langenbeck or the Furlow double z-plasty palatoplasty. Patients will be randomly assigned to four groups, to have with the von Langenbeck palatoplasty with intravelar veloplasty or the Furlow double opposing z-plasty palatoplasty between 9 and 12 months of age or between 15 and 18 months of age. Lip repair will be randomized to either the Spina or Millard method and will be accomplished by six months prior to palatoplasty. The major emphasis will focus on assessment of the near and long term outcomes of the palatal surgeries on velopharyngeal function for speech.

Eligibility Criteria:
Inclusion Criteria:

* Unrepaired unilateral cleft lip and palate
* Lip repair surgery to be accomplished by 3-6 months of age
* Able to return to research site at least once a year for follow-up

Exclusion Criteria:

* Patients with concomitant conditions (ie. mental retardation, deafness)
* Patients with Simonart Band of the cleft
* Patients who could not return to research site on a yearly basis
Enhanced Recovery After Surgery (ERAS) in Coronary Artery Bypass Graft / Off Pump Coronary Artery Bypass (CABG/OPCAB)

It has been assumed that some elements of the ERAS protocol may contribute to the reduction of complications and improve the satisfaction of patients undergoing coronary artery bypass surgery.

Elements of the ERAS strategy will be tested in this study. The elements that prove to be feasible and have a positive effect on the treatment process will be introduced into everyday clinical practice.

In the next stage of the research, we are planning to investigate whether the introduction of the ERAS strategy has had a long-term positive effect on the quality of life after treatment (a survey 1 month and 6 months after leaving the hospital).

Evaluation of the impact of implemented elements of the ERAS strategy on the results of surgical treatment of coronary artery disease in the aspect of:

* preoperative preparation (comprehensive information, premedication, hydration),
* haemodynamic stability (discontinuation of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers immediately before surgery), optimal pre- and intraoperative fluid therapy,
* occurrence of respiratory complications (assessment of the duration of mechanical ventilation and passive oxygen therapy),
* demand for painkillers in the postoperative period, after introducing the preemptive strategy,
* incidence of postoperative delirium,
* time to recovery of the normal bowel function (nausea, vomiting),
* possibility of early mobilisation on the first day after surgery,
* patient's satisfaction with treatment assessed on the basis of a survey carried out on the day before leaving the hospital.

Eligibility Criteria:
Inclusion Criteria:

* CABG/OPCAB (Coronary Artery Bypass Surgery/Off Pump Coronary Bypass Surgery).
* Left ventricular ejection fraction above 35% (EF ≥ 35%).
* The operation was performed in a planned mode.

Exclusion Criteria:

* Haematological diseases and the associated increased risk of bleeding in the early postoperative period. Patients taking anticoagulants until the day of surgery with the exception of aspirin.
* Neurological disorders, stroke with persistent symptoms, dementia.
* Chronic lung disease with hypoxia and the need for regular medication.
* Inability to move independently, disability preventing efficient rehabilitation, prolonged use of painkillers.
* Emergency surgery, reoperation.
* Return to the operating room regardless of the reason (resternotomy).
* Perioperative infarction with circulatory destabilization.
Investigation of Memantine in the Treatment of Memory, Concentration or Attention Problems

In this study, memantine will be tested in a new indication: in the treatment of subjective memory, concentration, or attention problems (subjective cognitive impairment) in the absence of dementia.


Eligibility Criteria:
Inclusion Criteria:

* Subjective worsening of memory, concentration or attention problems for longer than 6 months
* Subject can confirm that a relative or friend has noticed the memory, concentration or attention problems of the subject
* Experience of the memory, concentration or attention problems at least four times per week

Exclusion Criteria:

* Significant neurological disease or major psychiatric disorder (e.g. diagnosis of psychosis or dementia)
* Significant systemic illness, such as cancer, heart or kidney failure, uncontrolled diabetes
* History of stroke or seizure, or myocardial infarction within the last year (e.g. by inclusion questionnaire, physician interview)