cyrilzakka/clinical-trials huggingface dataset:
PreOPerative Imaging of NeuroEndocrine Tumors

Neuro-endocrine tumours (NET) are the most frequent tumours of the small intestine. In spite of their small size, these tumours have the particularity of forming mesenteric metastasis and ganglionic secondary lesions along the superior mesenteric axis, which is in close proximity to the superior mesenteric artery (SMA).

Surgery is the only curative treatment. The complete resection being a factor for good patient prognosis, risks of subsequent local complications (occlusion, bleeding) must be discussed. The limiting factor for resectability is arterial vascular invasion considering the risk of postoperative small bowel syndrome.

At the moment, the choice of imaging examination and its protocol is not standardized, nor the description of the tumoral mesenteric and ganglionic extension, especially the criteria defining a lymph node as lymphadenopathy. In addition, the complexity of SMA's anatomy and the absence of criteria for arterial invasion defining arterial invasion may lead to a misinterpretation of the preoperative imaging , and thus to an incomplete planning of the surgical procedure.

To correct this absence of radiological standardization, the investigating team has developed a reading grid for Computed Tomography (CT) aimed to facilitate preoperative planning of small bowel NET.

The main objective of the current study is to improve the semiotic description of the mesenteric and ganglionic tumoral extension of small intestine NET using a technically optimized imaging examination and a standardized reading grid in order to plan the best surgical procedure which would allow maintaining a minimal length of small intestine needed to yield a satisfying quality of life and nutritional status.

The secondary objective of this study is to evaluate the reproducibility of the standardized scanner's reading grid.


Eligibility Criteria:
Inclusion Criteria:

* Patients with small intestine neuro-endocrine tumors (NET) operated in the digestive surgical service of the University Edouard Herriot hospital of Lyon (Pr. Gilles Poncet) between the 1st of January 2014 and the 31st of March 2019,
* Having done a preoperative thoraco-abdomino-pelvic scanner with arterial and portal sequences.
* Scanner imaging, operative report and anatomo-pathological report available

Exclusion Criteria:

* no Computerized Tomography (CT) images available
Psilocybin for the Treatment of Cluster Headache

The purpose of this study is to investigate the effects of an oral psilocybin pulse regimen in cluster headache. Subjects will be randomized to receive oral placebo, low dose psilocybin, or high dose psilocybin in three experimental sessions, each separated by 5 days. Subjects will maintain a headache diary prior to, during, and after the pulse regimen in order to document headache frequency and intensity before, during, and after the pulse regimen. After at least 6 months from the last experimental session, subjects may be invited for a second round, in which they will be randomized to receive either low dose or high dose psilocybin.


Eligibility Criteria:
Inclusion Criteria:

* Chronic cluster headache with at least one attack daily
* Episodic cluster headache with periods that are predictable and have a duration of approximately 2 months
* Attacks are managed by means involving no more than twice weekly triptan use (e.g., high-flow oxygen, heat/cold pack)

Exclusion Criteria:

* Axis I psychotic disorder (e.g. schizophrenia, bipolar I, depression with psychosis)
* Axis I psychotic disorder in first degree relative
* Unstable medical condition, severe renal, cardiac or hepatic disease, pacemaker, or serious central nervous system pathology
* Pregnant, breastfeeding, lack of adequate birth control
* History of intolerance to psilocybin, lysergic acid diethylamide (LSD), or related compounds
* Drug or alcohol abuse within the past 3 months (excluding tobacco)
* Urine toxicology positive to drugs of abuse
* Use of vasoconstrictive medications (i.e. sumatriptan, pseudoephedrine, midodrine) within five half-lives of test days
* Use of serotonergic antiemetics (i.e. ondansetron) in the past 2 weeks
* Use of antidepressant medications (i.e. amitriptyline, isocarboxazid, fluoxetine, citalopram) in the past 6 weeks
* Use of steroids or certain other immunomodulatory agents (i.e. azathioprine) in the past 2 weeks
Artoss Prospective Spine Registry Outcomes

This prospective registry was designed as an observational study to ascertain how commercially available NanoBone Bone Graft is being used by surgeons performing spinal fusion as well as determining relevant patient outcomes.

This multicenter prospective patient registry was developed with the aim of documenting how spine and neurosurgeons are utilizing the NanoBone products along with relevant patient outcomes. These outcomes include radiographic measures such as fusion outcome, instrumentation integrity, and clinical outcomes (symptom and function improvement) based on investigator and patient-based outcome assessments.

The primary objective of this study is to document and analyze the use of NanoBone products in spine fusion surgery (as a stand-alone bone graft, or in combination with local bone only, no other BGS or biologic product used) and determine both radiographic success and clinical outcomes. All product related adverse events will be documented, tabulated, and summarized.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 years or older
* Patient is diagnosed with a degenerative spine disorder requiring spinal fusion, has failed conservative treatment, and has decided to undergo surgery.
* The surgeon has determined that a NanoBone product is or was clinically indicated, and will use or have used the product as a stand-alone bone graft substitute or in combination with local autograft only (no iliac crest harvesting, other BGS, or biologic {defined as containing growth factors, cytokines, proteins, or cells} used).
* Patient capable of understanding the content of the Informed Consent Form
* Patient willing and able to participate in the registry protocol including SOC follow-up visits and clinical evaluations.
* Patient who has agreed to participate in the registry by providing consent according to the applicable local law and the Declaration of Helsinki.

Exclusion Criteria:• Severe vascular or neurological disease

* Uncontrolled diabetes
* Severe degenerative disease (other than degenerative disc disease)
* Severely impaired renal function
* Hypercalcemia, abnormal calcium metabolism
* Existing acute or chronic infections, especially at the site of the operation
* Inflammatory bone disease such as osteomyelitis
* Malignant tumors
* Patients who are or plan to become pregnant.
* Uncooperative patients who cannot or will not follow post-operative instruction, including individuals who abuse drugs and/or alcohol.
A Study of Subjects Switched to Lurasidone for the Treatment of Schizophrenia or Schizoaffective Disorder

Lurasidone (lurasidone HCl) is a novel psychotropic agent that is being developed as a potential new antipsychotic treatment for patients with schizophrenia. Switching between antipsychotic medications is common in the treatment of schizophrenia. The purpose of this study is to characterize the long-term safety and tolerability of lurasidone in subjects with schizophrenia or schizoaffective disorder and to allow for continued treatment for subjects completing the core study (D1050289-NCT01143077).


Eligibility Criteria:
Inclusion Criteria:

* Subject has completed 6 weeks of treatment and all required assessments on the final study visit (Visit 8) of Study D1050289 (NCT01143077).

Exclusion Criteria:

* Subject is considered by the investigator to be at imminent risk of suicide or harm to self, others, or damage to property.
* Subject has a body mass index (BMI) greater than 40 or less than 18 kg/m2 (see Appendix 3 for BMI determination).
Study for Consolidation Period of Chronic Hepatitis B

The investigators aim to clarify the issue of adequate duration of consolidation period of Chronic hepatitis B infection with antiviral treatment with Tenofovir which could strike a balance between durable HBeAg seroconversion and avoiding long-term inevitable serological or virological recurrence.

According to practice guidelines of American Association of the Study of Liver Diseases, in patients of HBeAg-positive chronic hepatitis B, treatment should be continued until the patient has achieved HBeAg seroconversion and undetectable serum HBV DNA and completed at least 6 months of additional treatment after appearance of anti-HBe. Also several other current guidelines of anti-viral treatment of chronic hepatitis B infection suggest that nucleos (t) ide analogues treatment can be stopped following 6 to 12 months of consolidation therapy after HBeAg seroconversion. However, there is a paucity of data available about the long-term durability of Tenofovir induced HBeAg seroconversion as well as antiviral treatment associated resistance risk.

2. Primary end points: HBeAg seroconversion was defined as loss of HBeAg with concurrent appearance of HBeAb. Serological recurrence was defined as reappearance of HBeAg. Virological recurrence was defined as an increase of HBV DNA level to greater than 10,000 copies/mL after HBeAg seroconversion with previously HBV DNA levels less than 10,000 copies/mL.

3. Aims: To clarify the issue of adequate duration of consolidation period which could strike a balance between durable HBeAg seroconversion and avoiding long-term inevitable serological or virological recurrence.

4. Study design: A single-center cohort study which randomly allocating two different extended TDF treatment periods after HBeAg seroconversion - 12 months, and 18 months across patient groups. Then data will be collected about outcomes at a specific follow-up time.

Eligibility Criteria:
Inclusion Criteria:

* adult patients with chronic HBV infection (HBsAg-positivity for at least six months and HBeAg-positivity for at least three months) and serum HBV DNA levels ≥1000000 copies/ml (Cobas Amplicor HBV Monitor assay) at screening as well as serum ALT levels \>1.3 times the ULN (43 IU/L) on at least two occasions in the previous 6 months and at screening.

Exclusion Criteria:

* co-infection with HCV, HDV, or HIV and treatment with (pegylated) interferon or other nucleos (t) ide analogues for less than six months before the start of Tenofovir treatment.
Multiple Areas of Pain (MAP)

This study will collect pain-related information from chronic pain patients to gain an understanding of the prevalence of multi-site pain, and how it affects health outcomes like function, quality of life, depression, and anxiety.


Eligibility Criteria:
Key Inclusion Criteria:

* Chronic pain of the trunk and/or limbs lasting at least 6 months
* Overall pain intensity of at least 5 on a 0 to 10 scale
* Subject is able to independently complete all assessments in English
* 18 years of age or older
* Subject signs an Institutional Review Board-approved informed consent form provided in English

Key Exclusion Criteria:

* Currently implanted with an active implantable medical device to treat pain
* Currently exhibits any characteristic that renders the subject ineligible for current or future treatment with spinal cord stimulation for chronic pain of the trunk and/or limbs
* Subject has undergone an interventional pain procedure less than 1 month prior to the study
Occupational Distress in Doctors: The Effect of an Induction Programme

Background: Over 39% of approximately 3,000 doctors (The British Medical Association quarterly survey, 2015) admitted to frequently feeling drained, exhausted, overloaded, tired, low and lacking energy. Such occupational distress may link to psychological and physical difficulties in doctors and have negative outcomes for organization and patients. The aim of the current study is to investigate the impact of an induction programme on occupational distress of doctors.

Methods/design: Doctors will be invited to take part in an online research. Participants will be randomly assigned to the experimental and control groups. Participants in the experimental groups will complete one of the induction topics (about stress at work). Before and after an induction programme participants will be asked to fill in an online survey about their current occupational distress and organizational well-being.

Discussion: The investigators expect that doctors' psychological, physiological and organizational well-being will improve after an induction programme which should serve as a resource for better doctor's own health understanding.


Eligibility Criteria:
Inclusion Criteria:

* Medical doctors across all specialties and professional grades who have a regular contact with patients and works in the United Kingdom.
Evaluation of a New Device "Orthèse Diabète" in the Healing of Foot Ulcers in Diabetic Patients

Multi-center trial, randomized in 2 parallel groups, open label, with a blinded adjudication committee (PROBE methodology), comparing "Orthèse Diabète" with "conventional" removable devices in terms of healing of ulcers.

- Primary objective: Evaluate the efficiency of "Orthèse Diabète" compared to "conventional" removable devices, in terms of the proportion of diabetic patients whose principal ulcer will heal completely at 3 months.

1. Secondary objectives

   1. Proportion of patients whose principal ulcer will heal completely at 1, 2 and 6 months
   2. Proportion of patients in whom all initial plantar ulcers will heal completely at 1, 2, 3 and 6 months
   3. Percentage of area decrease of the plantar ulcers at 1, 2, 3 and 6 months
   4. Time to healing of the principal ulcer
   5. Appearance of new ulcers
   6. Requirement for amputation
   7. Incidence of the infectious complications
   8. Adherence of wearing
   9. Patient's satisfaction with the prescribed device
2. Population

   1. 13 centers/116 patients monitored for a period of 6 months maximum
   2. Experimental Group: "Orthèse Diabète" a plantar off-loading custom-made removable device
   3. Control group: "Conventional" removable off-loading systems among the devices available in France.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 or type 2 diabetic patients diagnosed according to the ADA experts consensus \[ADA 1997\]
* Over 18 years of age
* With a sensory neuropathy (abnormal 10 g monofilament test, i.e. not perceived at least 2 times in 1 of the 3 areas explored : pulp of the great toe, 1st and 5th metatarsal heads)
* Without a severe arteriopathy defined by : ABI \< 0,7 and/or TcPO2 \< 30 mm Hg and/or big toe pressure \< 30 mm Hg
* with one or more plantar ulcerations with an area \> 0,25 cm² or an amputation (toes or transmetatarsal) open or sutured
* not requiring a contralateral off-loading device
* Informed about the study and having given their informed and written consent to participate
* registered with a social security scheme or with the CMU (beneficiary or entitled recipient)
* having undergone a medical exam
* not included in another protocol throughout the study

Exclusion Criteria:

* Severe skin or osteoarticular infection requiring a parenteral antibiotic therapy or surgery
* Large ulcer of the ipsilateral leg \> 20 cm2 of area
* Contralateral above heel amputation
* Intercurrent disease prohibiting participation in the protocol
* Weight over 130 Kg
* Person under tutorship or under curatorship
* Loss of functional and/or neuropsychological autonomy
* Pregnant or likely to be pregnant woman
KeyScope Study in Uganda

KeyScope and KeyLoop (collectively called KeySuite) are laparoscopic prototypes that the investigators have designed for the resources, needs and challenges of low- and middle- income countries (LMICs). KeyScope is a laparoscope that plugs into a laptop computer to display images during surgery. It links to a telementoring application so that experienced surgeons can mentor surgeons in capacity-building partnerships. KeyLoop is a laparoscopic retractor that lifts the abdominal wall during surgery, obviating the need for a constant power supply and medical-grade carbon dioxide.

The investigators will perform a clinical First-in-Human study at the Uganda Cancer Institute. Ugandan surgeons will use the KeySuite devices to perform biopsies of intra-abdominal tumors.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of intra-abdominal mass suspicious for cancer
* body mass index (BMI) of 18-30
* weight 20-100kg
* biopsy necessary to determine cancer diagnosis and classify pathology
* surgeon determine that laproscopic biopsy it technically appropriate

Exclusion Criteria:

* significant comorbidities
* previous major abdominal surgery
* current pregnancy
Assessment Psychological Distress for Cancer Heredity Test

The study of hereditary cancer related syndromes allows reducing the risk of suffering in cancer to patients and close relatives. The objective of this study will be to evaluate the prevelance of psychological morbidity in patients attended at cancer genetic counselling unit, and to determine the socio-demographic and clinical factors that influence it.

A descriptive cross-sectional study will be carried out. Patients attented at the cancer genetic counselling unit, who have criteria for conducting a genetic syndrome test related to hererditary cancer, will be consecutively evaluated.

To knowing the psychological morbidity it is relevant to providing care for these patients.

Nowadays several familial cancer syndromes that confer a high lifetime risk of cancer can be identified with genetic testing. The psychological impact of genetic testing and the rates of psychological distress in patients undergoing genetic testing vary between 6 to 65% depending on socio-demographic or clinical characteristics.

The effect of baseline distress on post-testing assessments tended to decrease or show little change over time, it may be important to target patients with high baseline distress for additional counseling or intervention both pre-testing and over time.The most robust predictor of future distress is baseline distress, additional factors were associated with cancer risk perception considering family history of cancer, patient's affected or unaffected with cancer, etc...

It is relevant to developing and providing care for these patients, it has been demonstrated that enhanced genetic counseling with clinical psychologist to facilitate decision-making process, managing family concerns promoting their communication with and involvement of family members, and attending their emotional distress, can be beneficial. Also, cancer genetic counseling may promote patient use of personal resources and enhance patient health literacy about their syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 80 years
* Factors presumed predictive for hereditary cáncer
* They agreed to participate in the research.

Exclusion Criteria:

* Patients with cognitive impairment
* Patients with difficulties to read and understand Spanish language.
A Diagnosis and Treatment Optimization Study of Depression Based on the Neurological Mechanism of Reward System

Major depressive disorder (MDD) is a high-disabling disease. But its etiology and pathogenesis is not clear, and early recognition, diagnosis and treatment still has many challenges. Among numerous clinical manifestations of MDD, anhedonia is an important core symptom of MDD, especially in patients with melancholic features. Our previous studies and studies abroad have shown that MDD patients had functional abnormality in reward circuit. The abnormalities of reward-related core areas, such as the prefrontal cortex - nucleus accumbens - ventral tegmental area were closely associated with the development of MDD, and is an important neural basis of anhedonia. This study would take the reward circuit as mainline to carry out the etiology, diagnosis and therapeutic intervention studies of MDD. We would collect MDD patients with melancholic features and other populations with reward dysfunction. The neuroimaging techniques, stress assessment, genetic testing and drug intervention methods would be mainly used in this study. The functional connectivity of reward regions, such as the ventral striatum, nucleus accumben, and ventral medial prefrontal cortex, would be analyzed to identify the dysfunction of reward circuit of MDD, and its implication for early recognition, diagnosis and prediction of treatment efficacy of antidepressants. We would also investigate the effect of genetic and environmental factors on reward function of MDD and its biological basis. Finally, through modulating the reward circuit activity using animal experiments, we would verify and investigate reward dysfunction of MDD and its biological mechanisms. The project is expected to provide for new evidence for the establishment of reward mechanism - based objective diagnosis and treatment optimization strategy of MDD.


Eligibility Criteria:
Inclusion Criteria:

* first-episode, drug naive melancholic depression; remitted depression; schizophrenia patients; first-degree relatives of depressed patients.

Exclusion Criteria:

* major somatic diseases; DSM-IV axis I other mental illness; personality disorder, mental retardation; drug and / or alcohol dependence; serious suicidal tendencies or suicidal behavior; pregnant or lactating women; MRI contraindications.
Subcapital and Shaft Fractures of the 5. Metacarpal

The purpose of this study is to find out the best treatment for subcapital and shaft fractures of the 5. metacarpal.

It is a prospective randomized multicenter study. Comparing only fractures dislocated more than 30 degrees.

One group will be operated with intramedullary pins and one group will be treated conservatively with reduction and then Plaster of Paris for 3 weeks.

All patients will be followed up after 3, 6 and 12 months.

See above

Eligibility Criteria:
Inclusion Criteria:

* voluntarily, only isolated subcapital og shaft fracture of the 5. metacarpal,operated/reduction within 10 days of injury,not intoxicated,degree of fracture dislocation minimum 30 degrees measured on the X-ray.

Exclusion Criteria:

* open fractures, fractures of the head of 5. metacarpal/intraarticular fractures, patients who wants to be followed up at Hospitals outside the study area, earlier injury of the hand that might have influence on function.