cyrilzakka/clinical-trials huggingface dataset:
Comparison of Mood Disorders Screening Scales in Geriatric Oncology

The objective of this study is to evaluate the scales commonly used in geriatrics and oncology distress thermometer ( analogue scale rated from 0 to 1 for the emotional distress ) , the GDS15 (15 issues closed binary response seeking signs of depression ) the HADS (14 questions assessing the intensity of anxiety signs and signs of depression listed 0-3 ).

The prospective observational study will be conducted in parallel on two sites ( University Hospital Centre and François Baclesse ) after informed patient information.

It will be offered to patients 70 years and over with a new diagnosis or relapse of cancer or haematological malignancies in the hospital to meet the mood disorder screening questionnaires .

There are various tools validated and recommended by the SiO and SFPO for screening mood disorders in geriatric oncology . The choice among them depends on the usual practices of the various teams , only some scales assessing depressive signs and other signs of anxiety too. None were assessed in a population aged diagnosis of cancer or hematologic malignancy in pre- therapeutic situation.

The objective of this study is to evaluate the scales commonly used in geriatrics and oncology distress thermometer ( analogue scale rated from 0 to 1 for the emotional distress ) , the GDS15 (15 issues closed binary response seeking signs of depression ) the HADS (14 questions assessing the intensity of anxiety signs and signs of depression listed 0-3 ) The prospective observational study will be conducted in parallel on two sites ( University Hospital Centre and François Baclesse ) after informed patient information.

It will be offered to patients 70 years and over with a new diagnosis or relapse of cancer or haematological malignancies in the hospital to meet the mood disorder screening questionnaires .

If one test is abnormal , a clinical psychological care will be offered . When returning home : telephone contact will be made the same day with the doctor , asking him to please make thymic revaluation within 2 weeks ( informed patient). It will be sent to the doctor by post a rubric of Major Depressive Episode criteria of the DSM V to return . If the patient remains hospitalized , the doctor taking care of patient will be contacted to obtain the same information .

In addition, the investigators will study the impact on the management (change or introduction of an antidepressant and / or anxiolytic use of psychotherapy or psychological counseling ... ) to 5 weeks

Eligibility Criteria:
Inclusion Criteria:

* Patient 70 years and older with diagnosis of cancer or haematological malignancies ,
* New diagnosis or relapse announced
* Supported in the 2 c among : in consultation , or hospital geriatric or oncology / hematology specialty
* Affiliated Health Insurance

Exclusion Criteria:

* Cognitive problems preventing self
MR-Linac for Head and Neck SBRT

This study will evaluate the feasibility and safety of using MR-guided adaptive Head and Neck stereotactic radiotherapy (SBRT) at each fraction on the 1.5T MR-Linac.

At the Sunnybrook Odette Cancer Centre (OCC), stereotactic body radiation therapy (SBRT) (35- 50 Gy in 5 fractions delivered 2x/week) has been employed in a subgroup of palliative Head and Neck cancer (HNC) patients, as part of an institutional protocol, when greater tumor response is desirable when compared to more palliative regimens.

The MR-Linac has been approved by Health Canada for radiation treatment. With superior soft tissue contrast and the possibility for daily plan adaptation, it allows for higher treatment precision delivery, improved target coverage and greater normal tissue sparing.

As a first step, this study will evaluate the feasibility and safety of using the 1.5T MR-Linac on patients with HNC who are treated with SBRT.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and older
* Karnofsky performance status score of ≥70
* Biopsy-proven oligometastatic cancer to the HN
* Biopsy-proven primary HN cancer (either mucosal, nodal, skin)
* Patients deemed unsuitable by the treating radiation oncologist for radiation treatment with curative intent owing to advanced age, significant comorbidities, poor performance status, distant metastatic disease.
* ≥ 1 site amenable to HN SBRT
* Capable of providing informed consent
* Required to complete any systemic therapy ≥ 10 days prior to planned start of HN SBRT, with no plans to initiate systemic therapy ≥10 days following completion of HN SBRT.

Exclusion Criteria:

* History of radiation within the projected treatment field
* Contraindications to MR imaging per institutional policy
* Patients with connective tissue disorders
* History of severe claustrophobia
* Pregnant and or breastfeeding females
* Having an estimated glomerular filtration rate (GFR) \<40 ml/min/1.73m2
Efficacy of Surface Landmark Palpation for Identification of the Cricoid Cartilage in Obstetric Patients

Rapid Sequence Induction (RSI), with cricoid pressure is advocated for all obstetric patients undergoing general anesthesia. Applying cricoid pressure correctly is crucial to prevent aspiration. Using Ultrasound guidance we will be assessing the ability of different disciplines of caregivers to correctly localize the cricoid cartilage in obstetric patients by anatomical landmark palpation.

Obstetric patients coming for elective cesarean delivery will be recruited for the study. Informed consent will be obtained from the patient. The participant (anesthesiologist, resident, nurse, or RT) will mark the center of the cricoid cartilage with the patient in the sniffing position, using fluorescent "invisible" ink. Another anesthesiologist who is expert in using ultrasound will find the proximal and distal margins of the cricoid cartilage an will draw a line at the middle of the 2 margins. Evaluation of the participant's assessment will be considered accurate if it falls within 5 mm from the ultrasound's measured line .The assessor will also be asked to score the ease of cricoid cartilage palpation between 1 to 10 using a visual analog scoring (VAS) scale. Total time taken for palpation will also be measured.

Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years and older
* ASA 1-2•Having singleton pregnancy.
* Gestational age \>37.
* Elective cesarean section

Exclusion Criteria:

* Patient refusal.
* Renal failure.
* Severe preeclampsia.
* Non- scheduled caesarean delivery (urgent).
* Twin pregnancy.
Study of Sequentially Applied Repetitive Transcranial Magnetic Stimulation in Obsessive- Compulsive Disorders

The purpose of study was to investigate possible therapeutic effects and safety of sequentially combined low-frequency repetitive transcranial magnetic stimulation (rTMS) to the right dorsolateral prefrontal cortex (DLPFC) and supplementary motor area (SMA) in patients with treatment-resistant obsessive-compulsive disorder (OCD).

Obsessive-compulsive disorder (OCD) is a relatively common psychiatric disorder characterized by repetitive, intrusive thoughts and time-consuming behavioral or mental acts. Many OCD patients who do not respond to conventional treatments experience severe distress and disruptions in their daily activities. Novel approaches including psychopharmacological therapy and surgical techniques for treatment-resistant OCD have been proposed. With recent advances in non-invasive technique for stimulating the cerebral cortex, repetitive transcranial magnetic stimulation (rTMS) has been proposed as a potential therapeutic approach for various psychiatric illnesses including OCD.

Because of contradictory findings and a lack of controlled trials in OCD, rTMS cannot be yet recommended as routine therapy for OCD. However, it may have a potential clinical effect as a putative add-on treatment for OCD and an alternative therapy for treatment-resistant OCD.

For useful clinical applications, it is very important to develop methods to enhance the efficacy of rTMS. There are a number of putative ways to do this, and one of them is sequentially combining two forms of stimulation which are considered to have potential therapeutic effects. More recently, the sequential application of two stimulation regimens (high-frequency left-side rTMS and low-frequency right-side rTMS to the prefrontal cortex) has been found to have a substantial therapeutic effect in patients with treatment-resistant major depression. Therefore, the investigation for a sequentially combining effect of both the right prefrontal and the SMA stimulation would be worthwhile in OCD patients.

Eligibility Criteria:
Inclusion Criteria:

* OCD patients who had failed adequate trials (a lack of at least a 25% reduction in the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) 15 after at least eight weeks of treatment) of at least two serotonin re-uptake inhibitors (SRI) and behavioral therapy.

Exclusion Criteria:

* Subjects were excluded if:

  * they presented with a movement disorder other than a tic
  * any psychotic symptoms
  * other anxiety disorders
  * mental retardation
  * alcohol or other substance abuse within the last six months
  * a history of psychosurgery, encephalitis or significant head trauma
Functional Assessment in Liver Transplantation

This will be a prospective cohort study of patients with liver disease. Subjects will undergo geriatric assessments of frailty, functional status, and disability using functional status measures at baseline and at every clinic visit in the pre-transplant setting. Subjects will also answer questions regarding quality of life, personality, and/or cognitive function. Subjects will again undergo assessments at every clinic visit through 12 months after transplant. Then, they will be followed annually.

Patients will be asked to perform the following study procedures:

1. Assessment of cognitive function, quality of life, and/or personality using cognitive tests and questionnaires.
2. Measures of frailty and disability selected to capture the multi-dimensional aspects of frailty including functional status and physiologic reserve:

   Fried Frailty Score: weakness (test of grip strength), exhaustion (patient interview), slowness (gait speed), low activity (patient interview) Short Physical Performance Battery: repeated chair stands, balance testing with feet together, 13-foot walk
3. Laboratory tests will all be obtained from the medical record: creatinine, total bilirubin, INR, sodium, albumin. All of these tests are necessary for listing for liver transplantation.
4. Blood draw, urine and stool samples will be collected for a sub-group of 1000 patients.
5. Adipose, muscle, liver tissue, and blood will be collected during the liver transplant surgery for a sub-group of 1000 patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18 years old)
* Are seen for the treatment of liver disease
Mechanisms of Ultra-acute Hyperglycemia After Successful Resuscitation From Out-of-hospital Cardiac Arrest

The aim of the study is to describe the mechanisms of ultra-acute hyperglycemic response after return of spontaneous circulation (ROSC) in patients suffering out-of-hospital cardiac arrest. The investigators hypothesize that ischemia and reperfusion injury leads decreased secretion of insulin and glucose-like peptide 1 (GLP-1).

Two blood samples will be drawn: (1.) Immediately after ROSC and (2.) 60 minutes after first sample. Concentrations of glucose, insulin, glucagon and GLP-1 will be compared between the samples.

Metabolic profile will be compared between: (1.) diabetic and non-diabetic patients and (2.) survivors and non-survivors.


Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years
* witnessed cardiac arrest
* interval form emergency call to return of spontaneous circulation 10-45 minutes

Exclusion Criteria:

* severe pre-arrest disability leading to withdrawing treatment in prehospital phase
* no concent from next of kin
Fecal Incontinence and Rectal Static Disorder

This study evaluate the rate of occurrence of fecal incontinence in patients who had surgery for posterior pelvic static disorder versus those with medical management.

The aim is also to assess the natural history of constipation symptoms and quality of life in patients with posterior pelvic static disorder.

Data of all patients with posterior pelvic static disorder are collected prospectively and consecutively in the Fondamentum database since 2005, secured and hosted by the Rennes University Hospital.

The data from initial functional assessment, carried out as part of routine care between 2005 and 2019, include a clinical examination of pelvic static disorders, anorectal manometry, defecography, collection of symptoms by questioning and by a systematic questionnaire completed by the patient during the routine care consultation.

Patients identified from this database and meeting the selection criteria will receive an information letter along with a questionnaire and a stamped envelope for returning the questionnaire. The self-questionnaires will focus on collecting symptoms related to static disorders (incontinence, constipation, quality of life). Regarding the management of pelvic static disorder, we will detail whether it was operated or not, and what were the proposed medical care.

Upon receipt of the questionnaire, the new data will be entered into the research-specific database and will complete the clinical data resulting from the extraction of the care base The self-administered questionnaire sent to patients includes validated constipation (score of kess) and fecal incontinence (Cleveland) questionnaires, and quality of life questions from the validated SF36 questionnaire. It also includes a visual scale ranging from -5 to +5.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age
* Having a disorder of posterior pelvic statics
* Diagnosed during the period 2005 - 2019
* Having a functional assessment in proctology between 2005 and 2019 in the proctology department of the Rennes University Hospital Center (CHU)
* This complete functional assessment was carried out in consultation with proctology, as part of routine care, and included :

  * Data from the interrogation
  * Reported symptoms: incontinence, constipation and quality of life (collected through questioning and through a questionnaire systematically completed by the patient during the routine care consultation),
  * A clinical examination
  * Anorectal manometry
  * A defecography
* no one who does not object to participation in the research

Exclusion Criteria:

* persons of full age subject to legal protection (safeguard of justice, guardianship, trusteeship), persons deprived of liberty
Use of r-hLH (Luveris) in Donors Previously Treated With r-hFSH (Gonal F)

The purpose of the study is to compare the safety and efficacy of r-hLH to r-hFSH in the late follicular phase of young women undergoing controlled ovarian stimulation for oocyte donation.

While the role of FSH is considered the fundamental driver of folliculogenesis, the role of LH in this process is more controversial. FSH is associated with stimulating growth and recruitment of follicles while LH is associated with the selection of dominant follicles destined for ovulation. We will use an open, prospective, cross-over study to compare the safety and efficacy of two different treatment protocols for controlled ovarian stimulation in egg donors.

20 participants will undergo two cycles of stimulation. The first one will be with r-hFSH though the cycle and the second with r-hFSH then r-hLH. The participants will have 1 month rest cycle between the treatment cycles. r-hFSH doses will be adjusted according to patient response. r-hLH dosing will begin when there are 2 follicles greater than or equal to 14mm in diameter. The does will be 300IU/day and continue until the day of r-hCG administration.

Eligibility Criteria:
Inclusion Criteria:

1. Age less than or equal to 32 years old
2. BMI\<35
3. Eligible for controlled ovarian simulation
4. No PCO-type ovaries (PCO by USS image, \>2.1 LH;FSH ratio on cycle day 3, insulin resistance, increase of testosterone over free testosterone)
5. Meet all requirements for becoming an egg donor
6. Willingness and ability to participate and comply with study protocol for the duration of the study
7. Baseline FSH\<11

Exclusion Criteria:

1. Clinically significant systemic disease
2. Any contraindication to gonadotropin therapy
3. LH:FSH ratio greater than 3
4. Pregnancy in the past 3 months
5. Any medical condition which, in the judgment of the investigator may interfere with the absorption, distribution, metabolism or excretion of the drug
6. Simultaneous participation in another clinical trial
7. Known active substance abuse, including tobacco and alcohol (\>10 cigarettes/day)
8. Refusal or inability to comply with protocol
9. Known poor ovarian response
A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Opicapone in Subjects With Parkinson's Disease Taking Levodopa.

This is a phase 1, open-label study to assess the pharmacokinetics, pharmacodynamics, safety, and tolerability of opicapone when administered orally once daily for 14 days as adjunctive therapy to carbidopa/levodopa in subjects with Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

1. Have a clinical diagnosis of idiopathic Parkinson's Disease (PD) for at least 3 years with clear improvement with levodopa treatment
2. Be at a stable dose of maintenance medication(s) for PD, including stable doses of CD/LD
3. Subjects of childbearing potential who do not practice total abstinence must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment and follow-up periods of the study
4. Have a body mass index (BMI) of 18 to 40 kg/m2
5. Have a modified Hoehn and Yahr stage of ≤4 in the OFF state
6. Be able to tolerate an overnight period of 12 hours without CD/LD
7. Be in good general health and expected to complete the clinical study as designed

Exclusion Criteria:

1. Are currently pregnant or breastfeeding
2. More than 2 alcoholic beverages daily or more than 14 alcoholic beverages weekly within 7 days of Day -1 or consume any alcohol within 48 hours of Day -1.
3. Have motor fluctuations during the day (ie, effect of levodopa "wearing off" or having unpredictable "off" periods), or severe or intolerable levodopa-induced dyskinesia
4. Have had previous exposure to opicapone, or have an allergy, hypersensitivity, or intolerance to opicapone or other COMT inhibitor.
5. Have a history of a medical condition or surgical procedure that might interfere with absorption or metabolism.
6. Have a known history of neuroleptic malignant syndrome
7. Have an unstable medical condition or chronic disease
8. Have taken certain prohibited medications within 28 days of Day -1.
9. Have a known or suspected diagnosis of AIDS, or have tested seropositive for HIV
10. Have hepatitis A or B
11. Have a significant risk of suicidal or violent behavior
Feasibility Assessment of Neurophysiological Measurement in Veterans With LBP

This is study testing the feasibility of collecting neurophysiological measures of outcome related to body-based interventions for low back pain. The investigators will collect fMRI and psychophysical data about pain sensitivity before and after the interventions. Participants will be randomly assigned to either spinal manipulation or therapeutic touch groups. Participants will attend two practice sessions prior to the first data collection. There will be two follow-up assessments.

Participants will be enrolled from VA pain clinical at the North Florida/South George VA Medical Center.

The investigators will collect functional magnetic resonance imaging data of resting state and pain-related events (i.i. during thermal pain sensitivity testing, as well as psychophysical data to determine pain sensitivity. Pain sensitivity will be measured using thermal and mechanical stimuli. These data will be collected before and after the interventions, in addition to two follow-up sessions after intervention.

In addition, clinical measures of pain intensity in the low back, as well as trunk range of motion and strength will also be collected.

Eligibility Criteria:
Inclusion Criteria:

* complaints of current back pain that they rate at least 40 on a 101-point numeric rating scale
* Participants must able to understand written and spoken English

Exclusion Criteria:

* currently receiving treatment for LBP or have received SMT for LBP in the past year
* Quebec Task Force on Spinal Disorders (QTFSD) to identify patients with pre-existing nerve root compression, spinal stenosis, or post-surgery
* any chronic medical conditions that may affect pain perception (e.g., diabetes, high blood pressure, fibromyalgia, headaches)
* any contraindication to MRI
Move and Moderate in Balance

H1: The increase in body mass index between baseline and two year follow-up among intervention worksites will be lower than that among control worksites, such that the differential change will be negative on average.

Our overall objective is to develop and evaluate an intervention that will maintain or decrease body mass index; specifically, we will recruit and randomize 30 worksites to a two year intervention in which we will:

* Influence the worksite environment, including policies and procedures, by increasing worksite access to healthy foods and physical activity opportunities
* Promote individual behavior change, through increasing awareness of energy balance; building a physical activity intervention that will promote increased levels of energy expenditure through the combination of increased daily physical activity and regular, structured exercise; and building a dietary intervention that will promote decreased calorie intake.

Our primary aim is to:

1) Evaluate the effectiveness of the intervention in reducing or maintaining body mass index in a randomized controlled trial of worksites.

Our secondary aims are to:

1. Assess changes in worksite environment in access to healthy foods and physical activity opportunities attributable to the intervention
2. Assess changes in individual level physical activity and energy intake attributable to the intervention
3. Assess the changes in sequalae of weight loss including biomarkers of metabolic effects, and weight loss quality of life and symptom measures; and
4. Estimate the cost-effectiveness of the intervention in controlling weight.

Eligibility Criteria:
Inclusion Criteria:

* Employees of the enrolled worksite who are 18 years or older and work at the company at least 50% FTE (20 hrs per week)

Exclusion Criteria:

* Any employees of the enrolled worksite who are interns or seasonal workers or employees who work less than 50% FTE (20 hrs per week)