cyrilzakka/clinical-trials huggingface dataset:
Cervical Spinal Cord Metabolism and Microstructure in Amyotrophic Lateral Sclerosis(ALS)

The investigators want to know if magnetic resonance imaging can accurately provide an early diagnosis of amyotrophic lateral sclerosis (ALS).

Currently there is no definitive diagnostic test for amyotrophic lateral sclerosis (ALS). The investigators' goal is to determine if magnetic resonance imaging can provide an accurate diagnosis of ALS by looking at chemical concentrations in the spinal cord at the neck level which show up in MRI imaging and compare these chemical concentrations to corresponding measures in healthy control subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Adults age 18 to 80 years of age.

Exclusion Criteria:

1. Do not have active substance abuse
2. Do not have co-morbid psychiatric disease
3. Do not have opportunistic central nervous system infection
4. Do not have cerebrovascular disease
5. Do not have a contraindication for magnetic resonance imaging(MRI)(e.g. cardiac pacemaker, ferromagnetic or metallic implants).
6. Are not pregnant
7. Have not had cervical spinal surgery(neck) -
Chronic Dorzagliatin on Insulin and Incretin Function in Intermediate Hyperglycemia and Type 2 Diabetes

A total of 30 subjects will be recruited 15 with intermediate hyperglycemia and 15 in the tyep 2 diabetes group respectively. Eligible participants will undergo hyperglycemic-clamp/oral glucose tolerance at baseline and after 4 weeks of dorzagliatin treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Individuals aged ≥ 18 years but \< 70 years
2. Male or female
3. Body mass index of over 18 kg/m2 and \< 35 kg/m2

Additional inclusion criteria for IH group

* Fasting plasma glucose \<7.0 mmol/L and HbA1c \< 6.5%
* 1 hour plasma glucose ≥8.6 and \<11.6 mmol/L on 75g oral glucose tolerance test (OGTT)
* No use of glucose lowering drugs in past 6 months

Additional inclusion criteria for T2D group

* HbA1c 6.5 to 10% at screening
* On diet control, or stable dose of oral glucose lowering drugs metformin for at least 8 weeks

Exclusion Criteria:

* 1. Subjects who do not agree to participate in this study. 2. Country of birth is unknown. 3. Body weight less than 45kg. 4. Acute phase of cerebrovascular and cardiovascular diseases (within 6 months of recruitment).

  5. Subjects with severe renal dysfunction as defined by eGFR \<30 ml/min/1.73m2 or patients receiving renal dialysis (such as haemodialysis or continuous ambulatory peritoneal dialysis).

  6. Severe hepatic dysfunction as defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 3 times upper limit of normal.

  7. Severe cardiovascular disease, history of stroke, heart failure (NYHA III or IV) or history of myocardial infarction within last 12 months.

  8. History of drug abuse or excessive alcohol intake based on investigator judgment.

  9. Dehydration, diarrhoea or vomiting at the time of recruitment. 10. Subjects with severe infection, in perioperative period or with serious injury at the time of recruitment.

  11. Subjects with anaemia (Haemoglobin \<9.0mg/dL). 12. Pregnant or lactating or intending to become pregnant within 30 days after last dose of study drug.

  13. Participation in a clinical trial with investigational product within 30 days before enrolment.

  14. Donation or loss of blood (excluding the volume of blood that will be drawn during screening procedures) as follows: ≥300 mL of blood within 30 days prior to study drug administration.

  15. Subjects judged unsuitable for the study based on investigator judgment. 16. Use of strong or moderate CYP3A4 inhibitors or inducers and cannot be discontinued.

  17. Unwilling or unable to follow protocol requirements.
Early Cancer Detection Test - Lung Cancer Scotland

HYPOTHESIS In a high risk population the EarlyCDT-Lung test reduces the incidence of late stage tumours;3 / 4 / Unclassified (U) at diagnosis compared to normal clinical practice.

AIMS To assess the effectiveness of EarlyCDT-Lung test in increasing early stage lung cancer detection, thereby reducing the rate of late stage (3 / 4 / U) presentation, compared to normal clinical practice; to assess the cost-effectiveness of EarlyCDT-Lung test compared to normal clinical practice; to assess the effectiveness of EarlyCDT-Lung test in reducing adverse outcomes including potential psychological and behavioural consequences.

Eligibility Criteria:
Inclusion Criteria:

1. Participant is willing and able to give informed consent for participation in the study
2. Male or female aged 50 years to 75 years
3. Current or Ex-smoker with at least 20 year pack history
4. or Less than 20 year pack history but with family history of lung cancer in a 1st degree relative (mother, father, sister, brother, child)
5. ECOG Status: 0, 1 and 2 (Eastern Co-operative Oncology Group) Grade ECOG 0 Fully active, able to carry on all pre-disease performance without restriction 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2 Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours
6. Geographical postal sectors of:

NHS Geographical Area Eligible Postcodes Tayside DD1 - DD11, PH1-PH3 , PH6-PH8, PH10, PH11, PH13, PH15 \& PH16 Greater Glasgow \& Clyde G1-G5, G11 -G15, G20-G22, G31-34, G40 -G46, G51- G53, G60-G62 \&G64, G66 \& G69, G72 \& G73, G76-G78, G81-G83 PA1-PA8 (except PA6), PA11-PA16 \& PA19

Exclusion Criteria:

1. History of any cancer other than non-melanomatous skin cancer, cervical cancer in situ.
2. Symptoms suggestive of lung cancer within past 6 months (haemoptysis, unintentional weight loss (at least 5% in preceding 6 months).
3. Patients for whom the GP considers invitation to the study would cause undue distress.
4. Patients with other terminal disease.
5. Patients on prolonged / continuous use (\> 3months) of cytotoxic/ immuno-suppressant drugs eg: Cyclophosphamide. Monotherapy using glucocorticoids/ steroids eg prednisolone is NOT an exclusion criteria.
Collecting Recorded Videos of Colonoscopy Tests

The study shall mainly help to better evaluate the performance the APDS device and secondly it may help to assess the potential of the future alpha version of the device to be a useful and effective for the detection of colon Polyps.

Primary objectives: To evaluate, in objective way, the usability of the future alpha version of the APDS device by testing the sensitivity and specificity of its results achieved from running it on the collected recorded videos of Colonoscopy screening tests of the general population.

Secondary objectives: When the APDS would be ready for field installation (Beta Version), to install it in the Gastroenterology institute of the medical center, in order to evaluate, as part of a continuation study, the physicians satisfaction from the APDS performance.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must meet all the - criteria related to regular colonoscopy according to the standard of care at the Gastroenterology Department of the selected center, _In addition the following - criteria have to be met to be eligible for the study:

  1. Able to read, understand and provide written Informed Consent;
  2. Females or males - older than 18 years old

     Exclusion Criteria:
* Any of the following colonoscopy related exclusion criteria will exclude the subject from the study:

  1. Bleeding disorder or unacceptable risk of bleeding
  2. Terminal illness or life threatening malignancy
Orally Fludarabine, Adriamycin and Dexamethasone (FAD) in Newly Diagnosed Peripheral T-cell Lymphomas (PTCL)

The primary objective of this study is to evaluate the efficacy of Fludarabine, Adriamycin and Dexamethasone (FAD) as first line therapy in patients with Peripheral T-cell lymphomas (PTCL). 30 patients will be treated into this study.

Doxorubicin is often used to treat Peripheral T-cell lymphomas (PTCL). However, patients with PTCL have an especially poor outcome with a 5-year overall survival rate of only 26% following treatment with standard doxorubicin containing regimens. There is general agreement that results with conventional chemotherapy are so poor in patients with most PTCL that new approaches are warranted.The nucleoside analogs are Fludarabine being combined with other agents in PTCL (excluding ALK positive ALCL and primary cutaneous ALCL) is reported by others.We conduct a II stage clinical trials to evaluate the efficacy of Orally Fludarabine, Adriamycin and Dexamethasone (FAD) as first line therapy in patients with in Newly Diagnosed PTCL.

Eligibility Criteria:
Inclusion Criteria:

1. The diagnosis of peripheral T cell lymphoma must established by histological biopsy, and immunochemistry analysis and cytogenetic assessment should be done as well. The patients with peripheral T cell lymphoma (PTCL), PTCL-unspecified type(PTCL-u), angioimmunoblastic lymphoma (AILT) and non-skin type anaplastic large cell lymphoma (ALCL, ALK-).
2. Aged 18\~75.
3. Good performance status, ECOG score≤2. Estimated survival span \>3 months
4. Previously untreated.
5. At least 1 assessable disease (maximal diameter \>1.0cm, the disease foci located within the irradiated area are excluded) evaluated by CT or MRI, PET is also permitted.
6. Good compliance and inform consenting
7. Fit for the following criteria:

   * Absolute neutrophil count (ANC)≥1.5×109/L
   * Platelet（PLT）≥80×109/L
   * Total bilirubin (TBI) ≤upper normal limit (UNL)
   * Serum creatine (Cr) ≤UNL
   * Alanine aminotransferase (ALT) and Aspartate transaminase（AST）≤1.5 UNL

Exclusion Criteria:

1. Severe cardiac, renal or hepatic incompetence: serum direct bilirubin, indirect bilirubin, ALT, AST and Cr greater than 1.5 UNL; cardiac function greater than grade II. 28 days within the major surgical operation.
2. Other malignancy history (skin basement cell carcinoma and cervical carcinoma are excluded)
3. Severe uncontrolled underlying diseases
4. Pregnancy or lactation
5. Autoimmune disease history
6. Severe infection or metabolic diseases
7. Known allergic to multiple agents, including sulphanilamide.
8. Severe peptic ulceration or bleeding, contra-indicative for corticosteroids
9. Lymphoma involving central nervous system
Safety and Performance of 032-11 Haemostat in Cardiac and Thoracic Aortic Surgery

The effectiveness objective of this study is to evaluate whether 032-11 is non-inferior to Floseal as an adjunct to achieving haemostasis during surgical procedures involving cardiac and aortic thoracic surgery.


Eligibility Criteria:
Inclusion Criteria:

* The patient must be equal or greater than 18 years old
* The patient must have elective or non-elective urgent cardiac surgery or thoracic aortic surgery
* The patient must have no childbearing potential or have a negative serum or urine pregnancy test within 7 days of the planned surgery or in the opinion of the Investigator performs adequate contraception
* The patient is willing and able to be contacted for the follow-up visit at 6- 8 weeks
* The patient must provide written informed consent using a form that is reviewed and approved by the IEC

Exclusion Criteria:

* The patient is currently enrolled in this or another investigational device or drug trial that has not completed the required follow up period.
* The patient has a known hypersensitivity to materials of bovine origin
* The patient does not wish to receive materials of bovine or shellfish origin for any reason
Biocell Natural Killer Mixture in Diffuse Large B Cell Lymphoma (DLBCL) Patients

Primary objective:

* To compare the event free survival for 3years of R-CHOP plus Biocell Natural Killer Cell to R-CHOP therapy with DLBCL patients.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women of the age between 20 and 70
2. The patients who have measurable lesion using radiograph and have not received chemotherapy and radiation therapy after confirming DCBCL.
3. The patients with Ann arbor Ⅰ, Ⅱ, Ⅲ, Ⅳ
4. The patients who have not received NK / T-Cell lymphocyte therapy.
5. The patients who are expected to survive for at least 3 months.
6. The patients who or whose representative voluntary have written informed consent before performance of any study-related procedure.
7. Women of child bearing potential must have a negative pregnancy test within 7 days prior to study registration and agree to use adequate birth control during study treatment.
8. The patients with ADL classification (ECOG) scale 0, 1, 2
9. Patients who satisfy following hematologic criteria

   * WBC ≥ 3,000 / ㎕
   * platelet count ≥ 75,000 / ㎕
   * serum total bilirubin ≤ two times of upper limit of normal values of each laboratory
   * serum creatinine ≤ two times of upper limit of normal values of each laboratory
10. lymphoma patients who satisfy the following criteria

    * good renal function (GFR\> 50)
    * good hepatic function (total bilirubin level ≤ three times of upper limit of normal values of each test laboratory transaminases ≤ 5 times of the upper limit of normal value of each testing laboratory)
11. The patients with negative HIV surface antigen
12. The patients with negative HBV
13. The patients with negative HCV
14. The patients who have not received immunotherapy.
15. The patients who have not experienced tuberculosis infection within recent 6 months.

Exclusion Criteria:

1. The minors under 20 years of age (In accordance with Civil Code)
2. The patients diagnosed with other types of lymphoma
3. The patients who have central nervous system or meningeal involvement by lymphoma.
4. The patients who have contraindication of chemotherapy regimen
5. The patients with another active severe disease.
6. The patients who have history of cancer within 5 years
7. Uncontrolled hypertension patients
8. The patients who have hypersensitivity to Erythropoietin.
9. The patients who have the following diseases or the experience to have following disease within 3 months.

   * Myocardial infarction
   * Unstable coronary disease
   * Uncontrolled cardiac insufficiency.
   * Venous thrombosis
   * Pulmonary embolism
10. The patients who have experience to be treated with the pharmaceutical for clinical trials.
11. Pregnant and lactating women or women of childbearing age not using adequate contraceptive method.
12. The patients with clinically serious bacterial, viral or fungal infection
13. The patients of the test group who have the problem in NK cell cultures (Investigator will decide on this criteria with basis generated during NK cell culture)
14. Patients with autoimmune diseases
15. The patients who underwent visceral resection related with Lymphoma.
CO2 Laser vs Lidocaine for Vestibulodynia in Premenopausal Women

CO2 laser energy is currently used widely for the treatment of postmenopausal women who have vaginal atrophy due to the lack of estrogen. However, its effect on premenopausal women with hormonally-mediated vulvar vestibulodynia is unknown. This study seeks to evaluate the effect of CO2 laser on young women and compare it to topical lidocaine.

The purpose of this study is to see if vaginal laser therapy with MonaLisa Touch® will be more effective in treating vestibulodynia than current treatment with a topical lidocaine ointment. Vestibulodynia is a common bothersome condition and is more likely to occur in women on hormonal contraceptive treatment. To date, there are no effective treatments that address the underlying causes of the disease. MonaLisa Touch® is a laser procedure that delivers CO2 laser energy to the vaginal wall tissue. This energy causes the patient's own body to regenerate collagen and blood vessels, changing the tissue to make it healthier. The MonaLisa Touch® technology may help vestibulodynia by potentially fixing the underlying cause. This may be more effective than using the topical lidocaine which makes the tissue numb.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years to 40 years
* Hormonal contraceptive therapy for at least one year consecutive duration
* Vestibulodynia diagnosis meeting the following criteria:

  * Localized vulvar pain to vaginal vestibule
  * At least 3 months duration
  * Without clear identifiable cause

Exclusion Criteria:

* Suspected primary cause to vestibular pain that warrants directed treatment
* History of chronic infection or autoimmune disease
* Prior pelvic surgery including mesh placement for incontinence or prolapse, vestibulectomy, vulvectomy, or labiaplasty
* Active vulvar or vaginal infection
* Allergy or contraindication to topical lidocaine treatment
* Prior diagnosis or treatment of vulvar intraepithelial neoplasia or vulvar malignancy
The Influence of Endurance Sports Activity on the Oral Microbiota of Young Adults.

The oral cavity is an easily accessible anatomical site that accurately reflects the health of the individual. The mouth is considered an early indicator of biological aging, leading to the identification of oral biomarkers predictive of future alterations. Current data show that the oral health of high level athletes is globally altered with an increase in cariogenic indexes, an increased incidence of periodontitis, dental trauma and dry mouth syndromes. Few studies have focused on the oral microbiota compared to mouthguards used in rugby or boxing which seem to induce dysbiosis, a recent study shows an effect of ketogenic diet on bacterial changes in the mouth of endurance athletes. This project focuses on the impact of intensive sport practice on oral health and the identification of oral biomarkers associated with physical activity. The objective of this study is to investigate the impact of the amount of endurance sport practice on oral microbiota and oral health in young adults. the hypothesis is that a sedentary lifestyle and high-level sport induce depletion and/or changes in the oral microbiota compared to regular physical activity.


Eligibility Criteria:
Inclusion Criteria:

* Be between 18 and 30 years old
* If practicing sports, it must be an endurance sport as main activity (cycling or running)

Exclusion Criteria:

* Practice more than 3 hours of swimming per week
* Have taken anti-inflammatory drugs, less than 48 hours before the study
* Have taken antibiotics and/or probiotics, less than 3 weeks before the study
Bimodal, CROS and Severe Profound Hearing Loss Study

The study will involve the comparison of three groups with severe-profound hearing loss. Patients with a Cochlear Implant only, patients with a cochlear implant and Hearing Aid, and finally patients with two hearing aids.

This will enable a comparison of standard fitting protocols against the new rationale using the same devices. Devices used for patients in all 3 groups are now available in standard of care, and can be kept afterwards should the patients wish.

The study will involve three groups of 20 patients per group. This first is experienced adult bimodal users of the AB system who have usable contralateral residual hearing. A clinical baseline and three research conditions will be evaluated.

The Naida CI Link HA (Link) will be fitted, tested and then optimised using a special bimodal fitting formula. Subjects will be allowed three months to acclimatize and will then be retested. The second research condition will evaluate the fully integrated bimodal system, where the microphone signals from CI and HA are shared and a bilateral beamformer is formed. A third intervention will involve modifying the CI settings to minimize the mis-match between frequencies delivered via the CI.

A second group with no aidable hearing on their non-implanted ear will also be studied. A contralateral routing of signal (CROS) device will send sounds on the non-implanted side. Tests will be made with and without CROS, as well as with directional microphone settings.

Finally as a control group, bilateral HA users will be tested with the similar HA fitting as used for the bimodal group.

This will enable a comparison of standard fitting protocols against the new rationale using the same devices.

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18 years or above.
* Consistent unilateral user of an Advanced Bionics cochlear implant and a contralateral hearing aid for at least 6 months, ideally 12 months, and Bilateral severe to profound hearing loss (meeting NICE criteria for implantation-2009). (group 1)
* Consistent unilateral user of an Advanced Bionics cochlear implant for at least 6 months and ideally 12 months, with no useful contralateral hearing (group 2)
* Consistent user of bilateral hearing aids for at least six months (group 3) and bilateral severe profound hearing loss (80dB or worse at 2000 and 4000 Hz with speech discrimination of at least 50% IHR sentences live voice at 60dBA)
* First language English
* Post-lingual onset of severe to profound hearing loss
* No other handicaps that would interfere with participation in the study in the opinion of the Principle Investigator

Exclusion Criteria:

* Unstable cochlear implant or hearing aid fitting
* Using medication in an intermittent manner that might influence hearing levels
* Cognitive or psychological challenges that might lead to variations in attention