cyrilzakka/clinical-trials huggingface dataset:
CAMS-RAS: for Suicide Prevention

This Phase I feasibility study endeavors to create a prototype of a tool to determine its feasibility with suicidal patients in emergency departments (EDs). This is not a clinical trial. The overarching goal of this research is to create a tool that could reduce suicide rates, increase delivery of efficacious suicide interventions, and decrease overall costs associated with suicidal behaviors. SBIR Phase I project aims include: (1) creating an advisory board to guide the development of CAMS-RAS; (2) iteratively design and develop relational agent ("Dr. Dave") modeled after the gestures, expressions, and mannerisms of CAMS treatment developer, David Jobes, PhD; and (3) conduct feasibility tests to determine whether CAMS-RAS is acceptable, easy to use, and liked by target end-users: acutely suicidal patients admitted to hospital EDs, psychiatric inpatient units, and medical floors for treatment of injuries sustained during a suicide attempt; hospital medical personnel, administrators, and other stakeholders including peer advocates; and outpatient suicidal patients, clinicians and administrators.


Eligibility Criteria:
Patient Inclusion Criteria:

* English fluency
* 18 years or older
* receiving clinical care in a hospital or outpatient clinic for suicidality
* Suicidal patients currently admitted to EDs, psychiatric inpatient units, and medical floors, or patient with past (last 6 months) suicidality receiving outpatient treatment

Patient Exclusion Criteria:

* Acutely psychotic
* severely agitated (as determined by care team)
Maintaining Fitness During Neo-adjuvant Chemotherapy for Oesophago-gastric Cancer: a Feasibility Study

Feasibility study to investigate the utility of a simple, home-based, exercise intervention during and after neo-adjuvant chemotherapy but prior to surgery for esophageal and gastric adenocarcinoma.

The principle aim of this study is to test the feasibility of utilising a home-based 'prehabilitation' exercise regimen in oesophago-gastric patients during preoperative chemotherapy and the period leading up to surgical resection. The investigators also hope to explore secondary outcomes of such a regimen, such as maintenance of fitness, the incidence of sarcopenia, muscle function and the outcomes of therapy. The investigators will explore the added value of blood-borne frailty biomarkers to objectively measure changes in physiology during neo-adjuvant chemotherapy (NAC). This will be tested using CPET, CT measured sarcopenia, grip strength and a small panel of biomarkers as secondary outcome and exploratory measures. Thus the main question is: 'Will patients participate in a home-based exercise programme during and after NAC for oesophago-gastric cancer?'

Eligibility Criteria:
Inclusion Criteria:

* Operable adenocarcinoma of the oesophagus, oesophago-gastric junction and stomach (locally advanced adenocarcinoma with planned preoperative chemotherapy, T3+, T1/2 N+)
* Planned preoperative chemotherapy with ECX, ECX variant or FLOT chemotherapy
* Age \>18
* Ability to complete CPET
* Ability to consent to study and carry out the planned intervention.

Exclusion Criteria:

* Standard contraindications to CPET testing as defined by ATS Guidance
* Orthopaedic limitations to CPET and / or daily exercise, for example, amputation, severe knee or hip disease.
* Inoperable cancer at initial screening MDT
* Planned non-surgical treatment with either radiotherapy or combined chemoradiotherapy
Sleep, Physical Activity and Multiple Sclerosis Symptoms in Pediatric Multiple Sclerosis

Most youth with MS experience symptoms such as depression and fatigue. In addition, cognitive issues, especially with attention and memory occur frequently. However, little is known about interventions that might work to improve these symptoms. In other work, the investigators have shown that higher levels of physical activity are associated with lower levels of depression and fatigue. Importantly, sleep problems are frequently encountered in youth with MS, and were seen in 60% of surveyed youth with MS in the investigators preliminary work. Modifiable lifestyle factors such as sleep and physical activity (PA) may play a key role in ameliorating common symptoms in pediatric MS. However, sleep has not been objectively described in pediatric MS, and the relationship between PA and sleep is poorly understood. This study aims to address these gaps.


Eligibility Criteria:
Inclusion Criteria:

1. Children ages 10 to 17 years, 11 months;
2. MS diagnosis following standard definitions (IPMSSG);
3. Healthy controls will include any child without a history of disease or disability

Exclusion Criteria:

1. Inability to communicate or understand English;
2. Those within 30 days of a relapse;
3. Children who exhibit severe respiratory problems at baseline (e.g. use of tracheotomy)
Development of Stimulator Pneumatic for Realization of Evoked Potential Allodynic/Somatosensory

The stimuli used in the evoked potentials are electrical or laser. They are started and synchronized with the collection of the EEG by signals TTL (transistor-transistor logic). Investigators propose to validate a pneumatic stimulator delivering the compressed air sync with the EEG. It has two advantages over existing stimuli: Is capable of inducing in patients an allodynic response, excessive, painful, in response to a stimulation painless rarely obtained with laser or electrical stimuli. Therefore, the pneumatic stimulation is a means to study allodynic evoked potentials unknown to date.

It must be possible with a single stimulator to explore non-painful sensations and allodynic sensation , compare them with one device. The differences are the abnormal responses. This validation assumes evoked potential recording 1. somatosensory (low stimulation) then 2. allodynic (only in patients). The study therefore provides for the registration 100 potential for each of these two modalities in patients and only for the painless pneumatic modality in volunteers.


Eligibility Criteria:
Inclusion Criteria of patients :

* Major Patient
* Patient affiliated or entitled to a social security scheme
* Patient with neuropathic pain authenticated by the neurologist, with the presence of allodynia.
* Patient has given its written consent to participate in the study

Exclusion Criteria of patients :

* Diseases affecting the nervous system,
* Diabetes,
* Patients who received chemotherapy
* Pregnant woman
* Nobody in emergencies
* A person unable to give consent

Inclusion Criteria of healthy volunteers :

* Major subject
* Subject affiliated or entitled to a social security scheme
* Subject has given its consent to participate in the study

Exclusion Criteria of healthy volunteers :

* Diseases affecting the nervous system,
* Diabetes,
* Patients who received chemotherapy
* Pregnant woman
* Nobody in emergencies
* A person unable to give consent
AcoArt IV / SFA in China:Drug-eluting Balloon for SFA Angioplasty Evaluation in China

The registry is a prospective, multicenter, single arm post-market real-world registry in China assessing the clinical use, safety and outcomes of the Orchid 035 DCB Catheter in the Superficial Femoral Artery (SFA) and Popliteal Arteries (PA).

PTA is an established alternative to open surgical bypass for the treatment of infrainginual disease of critical limb ischemia.

DEBs are designed to promote arterial patency by reducing neointimal proliferation.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 80 years
* Patients with peripheral artery disease (PAD), with Rutherford classification between 2 and 5
* an occlusion or a minimum grade of stenosisPrimary over 70% in the superficial femoral artery an /or the popliteal artery
* Total length of treat lesion(s)is less or equal to 20cm
* signed Patient informed consent form

Exclusion Criteria:

* plasma Cr level greater than 150 umol/L in patients
* patients with acute thrombosis requiring lysis or thrombectomy
* 2 or more than 2 stenosis lesions in traget vessel
* patient with a lysis or an lower limb intervention as a therapy within the last 6 weeks
* patient requiring intervention in both lower limbs at the same time
* have \>30% residual stenosis or blood-limited dissection after predilation
* distal outflow through less than one lower leg vessel
* known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc.
* patients participating in another clinical trials with interfere with this trial in the past 3 months
* pregnancy and lactating woman
* untreatable bleeding diatheses
* other diseases, such as cancer, liver disease, or cardiac insufficiency, which may lead to protocol violations or markedly shorten a patients's life expectancy(less than 1 years)
* patients unable or unwilling to participate this trial
In Vivo Confocal Microscopy of Cutaneous Neoplasms and Normal Skin

The purpose of this study is to investigate new non-invasive imaging techniques for the evaluation of skin lesions, as well as normal skin. Our primary goal is to collect and study these images of different skin lesions along with matching biopsy specimens. The long-term goal is to develop a technique that will improve the early detection of skin cancer and eliminate the need for many skin biopsies.

The High-resolution OCT (Apollo Medical Optics) device can provide both cross-sectional and en-face images with cellular information. Real-time color images through the same objective with OCT are also provided to show the OCT imaging location of lesion. The color image can be registered simultaneously on a larger dermoscopic image obtained by an external dermoscope. The imaging mode of cross-sectional, en-face and color image can be switched arbitrarily to align the lesion and obtain high-resolution images efficiently. The total imaging time is around 10 to 15 minutes depending on the number of images to be obtained.

To help identify more diagnostic features of optical imaging and better understand their histology correlation, we have developed a novel technique called "precision biopsy". Precision biopsy is an optical imaging guided, feature-targeted mini-biopsy. Once the feature of interest is identified and isolated by the optical imaging, a 2.0 mm punch biopsy is performed. Besides cosmetic benefit of minimal scarring, this tissue sparing biopsy captures the "feature of interest" for histology revelation.

Additionally, the histologic features of precision biopsy will be compared to images gathered by multi-modal optical imaging. The precision biopsy will also be compared to the traditional shave biopsy or shave excision, to determine whether the diagnostic information is comparable between the two methods.

For live remote control (LRC) imaging consultation, MSK dermatologist will based on his clinical examination. An imaging technician will perform the clinical and dermoscopic imaging, while the expert reader will perform confocal imaging remotely via a HIPPA compliant Webex platform.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than or equal to 10 years of age.
* Patients with a skin lesion with anticipated epidermal and superficial dermal histologic alterations amenable to visualization by surface confocal microscopy.
* Healthy volunteer subjects older than or equal to 10 years old.
* Ability to give informed consent.

Exclusion Criteria:

* Patients who are allergic to fluorescein sodium.
Platelet Products Tested With the ThromboLUX® Platelet Quality Test

The planned minimal risk study is a blinded study on consecutive transfusable platelet products. The aim of the study is to evaluate the quality of platelet components sampled prior to transfusion.

The primary patient transfusion outcome in this study is the 1-hour corrected count increment (1 hr CCI), which is a widely accepted clinical outcome measure. Platelet products will be sampled for ThromboLUX testing before being sent from the blood bank to the treatment center. After receipt at the treatment center, the platelet products will be used as per regular clinical practice, and the outcome data from each patient will be collected. At the end of the study, TLX Scores will be compared to the transfusion outcomes to determine if a low TLX Score is associated with a poor transfusion outcome.

During the course of the study, the TLX Score will not be known to the clinicians, or utilized in any way to decide if the platelet product should be transfused.


Eligibility Criteria:
Inclusion Criteria:

* adult hematology-oncology outpatients
* stable and thrombocytopenic

Exclusion Criteria:

* age \<18 yrs
* splenomegaly
* unable to provide informed consent
* pregnancy
* acute promyelocytic leukemia
* ITP (Idiopathic thrombocytopenic purpura)
* HUS
The NORDSTEN Studies/ The Spinal Stenosis Study

Lumbar Spinal Stenosis (LSS) is a clinical entity were narrowing of the spinal canal gives a compression of the the neural and vascular structures in the spinal canal. This often gives neurogenic claudication and sometimes severe Low Back Pain (LBP). Surgery for LSS is today the most often performed procedure in the adult lumbar spine. Beneficial effect of surgical treatment is well documented by several clinical trials, and a Cochrane review article from 2005 concludes that surgical treatment is superior to non-surgical treatment. The surgical solution is to decompress the stenotic part of the lumbar spine. There is no consensus in the literature of which surgical method that gives best long term clinical results. The investigators are therefore planning a Randomized Controlled Trial, where they will compare clinical and radiological results of three different surgical methods for LSS. The main outcome of this study is to answer which surgical method that gives the best long term clinical results. And, secondary outcome is to find out how much increase of the Dural Sac Cross Sectional Area is needed to give a long time relief of the patients' symptoms.


Eligibility Criteria:
Inclusion Criteria:

* have clinical symptoms of spinal stenosis as neurogenic claudication or radiating pain into the bilaterally to the lower limbs, not responding to at least 3 months of conservative treatment.
* Radiological findings corresponding to the clinical symptoms of LSS. Central -stenosis, or lateral recess-stenosis.
* be able to give informed consent and to answer the questionnaires.
* over 18 years of age-have -not responding to at least 3 months of non-surgical treatment.
* be able to understand Norwegian language, spoken and in writing

Exclusion Criteria:

* have a degenerative lumbar spondylolisthesis, with a slip ≥ 3 mm verified on standing plain x-rays in lateral view.
* are not willing to give written consent.
* have former surgery in the level of stenosis.
* fracture, or former fusion of the thoracolumbal region.
* cauda equina syndrome (bowel or bladder dysfunction) or fixed complete motor deficit.
* are ASA- classified 4 or 5.
* are older than 80 years
* have a lumbosacral scoliosis more than 20 degrees verified on AP-view
* have distinct symptoms in one or both of their legs due to other diseases, e.g. polyneuropaty, vascular claudication or osteoarthtris.
* LSS in 4 or more levels.
* not able to comply fully with the protocol, including treatment, follow-up or study procedures (psychosocially, mentally and physical).
* the patient is participating in another clinical trial that may interfere with this trial
Gestational Diabetes: Insulin or Oral Hypoglycemic Agents?

Gestational diabetes mellitus takes place in 2 steps. First, it is the consequence of insulin resistance due to the modifications of the pregnancy hormonal environment, and second, of the deficiency of the beta cells of the pancreas to respond by a sufficient insulin secretion. This physiopathology is closely connected to the one of type 2 diabetes. Insulin, indeed, can remedy these 2 etiologies, but it is logical to think about using oral hypoglycemic agents which have been created to treat them: they are a natural choice because they improve insulin sensitivity (metformin, a biguanide) or insulin secretion (glyburide, a sulfonylurea). It also seems natural to use them in combination, glyburide being added to metformin if needed.

OUR GENERAL RESEARCH HYPOTHESIS IS THAT: in pregnant women with gestational diabetes mellitus, using both oral hypoglycemic agents (glyburide added to metformin if needed) allows a glycemic control comparable to the one obtained with insulin, but with a better acceptability from women and a better health status, diabetes treatment satisfaction and well-being and a reduced postnatal depression.


Eligibility Criteria:
Inclusion Criteria:

* women,
* age ≥ 18 yrs,
* with gestational diabetes at 24-28 weeks (Canadian Diabetes Association (CDA) criteria),
* who need a pharmacological treatment following the failure of the diet and exercise,
* to understand and read French or English.

Exclusion Criteria:

* known type 1 or type 2 diabetes,
* treatment interfering with glucose metabolism,
* allergies to one of the components of the treatment,
* hepatic or hematologic diseases.
Clinical Investigation to Evaluate the Ability of MammoWave in Breast Lesions Detection

This is a multicentric, single arm, prospective, stratified by breast density clinical investigation using Mammowave that is a device, which uses microwaves instead of ionizing radiation (X-ray)for breast lesions(BL) detection. Specifically, Mammowave employs a novel technique which generates images by processing very low power (\<1 mW) microwaves. The exam takes few minutes per breast and is performed with the patient lying in a comfortable facing down position. Mammowave is safe to be used at any age, in any condition (pregnancy, specific illness) and for unlimited number of times.

The number of participants will be 500 (for all the sites). The Study will be composed of two phases: a preliminary phase to 'optimize the imaging algorithm for each apparatus installed at each centre', where 15 healthy volunteers in each centre will be examined by MammoWave. In the second phase, the remaining people will be enrolled (Breast Lesions pts will be about 70% of total) and examined by MammoWave by the clinical investigator, and results will be compared with the effective diagnosis already obtained by standard clinical methods. BL includes malignant lesions (BC) and benign lesions, and may be palpable or non-palpable lesions. BL includes also isolated clustered microcalcifications.

At the end of the study, in each centre the clinical investigators will compare MammoWave output against the radiologist study output obtained using conventional exams.

In addition, at the end of the study, the MammoWave output will be centrally reviewed in blind by an independent radiologist in order to confirm the data and confirm centrally the comparisons performed locally. The primary goal of the clinical study is to assess Mammowave's ability in BL detection and differentiation.

Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed consent Form
2. Women
3. Adult ≥18 years old
4. Having a radiologist study output obtained using conventional exams (such as breast specialist visit and mammography and/or ultrasound and/or magnetic resonance imaging) within the last month.
5. Patients willing to comply with study protocol and recommendations.
6. Patients with intact breast skin (i.e. without bleeding lesion, scar).

Exclusion Criteria:

1. Patients that are enrolled in another clinical study
2. Patients who belong to any vulnerable group.
3. Patients with implanted electronics.
4. Patients who have undergone biopsy less than one week before MammoWave scan
5. Patients with breast implants
6. Patients with nipple piercings (unless they are removed before MammoWave exam).
7. Participation in other studies in the last month before screening
8. Pregnancy or breastfeeding
Randomized Controlled and Prospective Trial of a Cohort of People Who Made a Suicide Attempt

The prevention of recurrent suicidal about people who have made a suicide attempt is a major strand in the prevention of suicide. It is estimated that 10-15 % of people who made a suicide attempt die by suicide. Recidivism rate of suicide increases even faster than the subject is close to the index suicide attempt. A one month recurrence rate is 5 %, 12-25 % at one year. Most people who made a suicide attempt receive ambulatory monitoring. On this population, there is a low adherence to care.

The main objective of the study is to test the effectiveness of a prevention program of recurrent suicidal acts for people who made a suicide attempt.

The secondary objectives of this study are the assessment of adherence to care; the identification of sub - populations benefiting most from this program; the evaluation of the possible generalization level of the program (eligibles persons rate) and its feasibility level.

This is a randomized, controlled and prospective trial comparing an experimental group (usual treatment + interventions) to a control group (usual treatment only). All participants are evaluated after one year of monitoring. The search duration is 2 years (one inclusion year and one year of follow-up). It is planned to include 330 patients, 165 patients in each group.

The program (experimental group) includes three interventions:

* A series of three telephone calls ( the second week , one month and three months after discharge from hospital )
* A systematic telephone contact with the referring physician
* A telephone helpline for people who made a suicide attempt and referring physicians.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years.
* Patients admitted to the emergency department for a suicide attempt.
* Patients referred to outpatient care.
* Patients who have given their written consent.

Exclusion Criteria:

* Patients not affiliated to social security.
* Patients do not have the faculties needed to be evaluated (cognitive or delusional disorder).
* Patients hospitalized for longer than 72 hours.
* Patients can not be recalled by phone (no phone, homeless, incarcerated)
* Patients who do not speak French.
The Role of Microsurgery in Surgical Treatment of Varicocele.

This study is to set the place of microsurgery in surgical treatment od varicocele in infertile male. Fourty patients will undergo microsurgical subinguinal varicocelectomy while the control group consisting of 20 patients wil undergo laparoscopic varicocelectomy.


Eligibility Criteria:
Inclusion Criteria:

* clinical varicocele
* infertility duration of min one year
* poor semen quality
* otherwise unexplained infertility in the couple

Exclusion Criteria:

* female infertility
Lifestyle Guidance Methods in NAFLD

To determine the efficiency of lifestyle modification (due to a dietitian or digital application) compared to standard of care.


Eligibility Criteria:
Inclusion Criteria:

* NAFLD based in FibroScan measurements

Exclusion Criteria:

* excessive alcohol use
* other causes of liver disease
* secondary causes of liver steatosis
Stage-Specific Recovery Changes in the International Classification of Functioning Components Following Conservative Rehabilitation of Trigger Finger

The aim of this study was to determine the effectiveness of conservative rehabilitation on the multi-dimensional health components based on WHO ICF model in Stage 1, Stage 2 and Stage 3 trigger finger and to determine the functional recovery patterns of each dimension during a three-month rehabilitation period. Thirty-four patients were participated in the study.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Stage 1, Stage 2 and Stage 3 trigger finger based on the Froimson Classification

Exclusion Criteria:

* Paediatric trigger finger, trigger thumb, concomitant de'Quervain tenosynovitis, carpal tunnel syndrome, or Dupuytren's contracture, neurological or rheumatological diseases, chronic pain syndromes, pregnancy and patients with treatment history of related finger/fingers.