cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Safety, Tolerability and Drug Levels of BMS-986447 in Healthy Participants

The purpose of the study is to evaluate the safety, tolerability and drug levels of single, oral doses of BMS-986447 in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index between 18 and 30 kilograms per metered square (kg/m\^2), inclusive.
* Healthy male and female participants without clinically significant deviation from normal in medical history, physical examination, ECG, and clinical laboratory determinations.
* A negative COVID-19 test, which will be performed in the manner mandated by the clinical side where the study is being conducted, at screening and check-in Day -2.

Exclusion Criteria:

* Participant has any condition that confounds the ability to interpret data from the study.
* Participant has any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if the participant was to participate in the study.
* Any major surgery or planned surgery (except gastrointestinal \[GI\] surgery, as described below) within 12 weeks of study intervention administration.

Note: Other protocol-defined inclusion/exclusion criteria apply.
The Effects of Pregnancy Classes and Contributing Factors to Postpartum Depression

It is recommended by the American College of Obstetricians and Gynecologists' Committee on Obstetric Practice that all obstetricians screen each women for postpartum depression and anxiety with a validated instrument. Although much effort is made, the contributing factors still lack in the literature due to its multi-factorial nature and complexity.

In addition, the effects of prenatal education classes remain understudied. Therefore, this study aims to demonstrate the prevalence, characteristics and contributing factors of the postpartum depression. In addition, the change in prevalence and characteristics of the postpartum depression among women who had prenatal classes and not will also be assessed.

Specific and validated instruments will be performed to women in their 8th week of postpartum period.

Those instruments are:

Edinburgh Postpartum Depression Scale (EPDS) Female genital self-image scale (FGSIS) Insomnia Severity Index (ISI) Breast-feeding efficacy scale short form (BSES-SF) Beck Depression Scale

Eligibility Criteria:
Inclusion Criteria:

* All women in the puerpera period (who gave consent)

Exclusion Criteria:

* None.
Survey on Epidemiology of Hypoparathyroidism in France

Very few data has been published on the epidemiology of hypoparathyroidism worldwide: none exists specifically for France. Hypoparathyroidism could led to complications. Here, the investigators plan to collect data about both epidemiology, medication and complication of hypoparathyroidism in France.

Very few data has been published on the epidemiology of hypoparathyroidism worldwide. None exists specifically in France. Hypoparathyroidism could led to complications: e.g. symptomatic hypocalcemia, calcifications (brain, eye and other soft tissues), nephrolithiasis/nephrocalcinosis, renal insufficiency. Here,the investigators plan to collect data about both epidemiology, medication and complication of hypoparathyroidism in France.

Eligibility Criteria:
Inclusion Criteria:

* patient fro whom chronic hypoparathyroidism is diagnosed
* patient living in France

Exclusion Criteria:

* patient who does not want his data to be collected in this registry
* pseudo-hypoparathyroidism
* acute hypoparathyroidism
Parent Psychoeducation and Cognitive Behavior Therapy for Latino Adolescents With Depression

This study will determine the effectiveness of adding a parent-involved intervention to cognitive behavior therapy in reducing depressive symptoms among Latino adolescents with depression.

Adolescent depression can have a devastating impact on social, emotional, and family functioning. Cognitive behavior therapy (CBT) is the most common treatment for depression; however, not all patients respond adequately to CBT. In addition, data on the effects of CBT among ethnic minorities are limited. Because Latinos are the largest minority group in the United States, the development of treatments specifically designed for depressed Latino youth are needed. This study will determine whether adding a psychoeducation intervention with parent involvement will be more effective in reducing depressive symptoms among Latino adolescents than treatment with CBT alone.

The treatment phase of this study will last 12 weeks. Participants will be randomly assigned to receive 12 weeks of either CBT alone or CBT with psychoeducation. The psychoeducation will consist of 8 sessions over the 12-week treatment period. During the sessions, participants and their parents will be given detailed information about depression and ways the condition can be treated. They will also be taught coping skills and ways to recognize a relapse. CBT sessions will take place weekly during the study. During the sessions, a therapist will work with participants to modify the behavior and thinking patterns that cause and are associated with their depressive symptoms. Both participants and their parents will undergo interviews at study start, study completion, and 3, 9, and 15 months after study completion. During the interviews, participants' depressive symptoms, school attendance, and overall functional status will be assessed. Parents' stress levels and work attendance will also be assessed. At Months 6 and 12 after study completion, participants and their parents will complete questionnaires to assess any relapses in depressive symptoms.

Study hypothesis: Active treatment with psychoeducation will be superior to no psychoeducation in reducing depression post-treatment. Because the psychoeducation intervention is designed to involve parents and thus impact other aspects of the family system, the treatment is expected to produce better outcomes in several functional domains.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of depression
* Parent or guardian willing to provide informed consent

Exclusion Criteria:

* Psychiatric conditions other than depression
PET Imaging Using 64Cu-Tz-SarAr and hu5B1-TCO in People With Pancreatic, Colorectal, Bladder Cancer or Cancers With Elevated CA19.9

The purpose of this study is to find the highest safe dose of hu5B1-TCO and the best dosing schedule of hu5B1-TCO and 64Cu-Tz-SarAr for finding cancer cells that are CA19-9 positive. This study will also help to find out how much radiation the body is exposed to when 64Cu-Tz-SarAr is used, and provide information on the way the body absorbs, distributes, and gets rid of 64Cu-Tz-SarAr.


Eligibility Criteria:
Inclusion Criteria:

Patients will be eligible for enrollment if they fulfill the following criteria:

1. Signed informed consent
2. 18 years of age or older
3. Histologically confirmed primary or metastatic pancreatic ductal adenocarcinoma/bladder carcinoma / gastrointestinal tumor reviewed at MSK - includes patients with biopsy-proven or high suspicion on imaging for pancreatic ductal adenocarcinoma (PDAC) or histologically confirmed, locally-advanced, or metastatic pancreatic ductal adenocarcinoma (PDAC) of

Patient with solid tumors increased serum CA19-9 serum level greater than ULN or CA19-9 positive biopsy

4. At least one lesion by CT or MRI ≥ 2 cm unless determined otherwise for presurgery subjects 5. ECOG performance status of 0 to 2 6. Adequate laboratory parameters including: i. Absolute neutrophil count (ANC) ≥1.5 x 109/L ii. Hemoglobin ≥ 9.0 g/dL iii. Platelet count \>75,000/ mm3 iv. AST/SGOT, ALT/SGPT ≤2.5 x ULN, unless liver metastases are clearly present, then ≤5.0 x ULN v. Total bilirubin ≤ 1.5x the upper limit of normal unless considered due to Gilbert's syndrome in which case, ≤3x the upper limit of normal vi. Creatinine clearance (CLcr) (\> 60 mL/min) estimated by the Cockcroft-Gault (C-G) equation or estimated glomerular filtration rate (eGFR) 10. Willingness to participate in collection of pharmacokinetic samples

Exclusion Criteria:

Patients will be excluded from the study if they fulfill any of the following criteria:

1. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
2. Major surgery other than diagnostic surgery within 4 weeks of Study Day 1
3. History of anaphylactic reaction to human, or humanized, antibody
4. Other on-going cancer therapy with investigational agents
5. Known history of HIV
6. Pregnant or currently breast-feeding

   a. Subjects and their partners with reproductive potential must agree to use an effective form of contraception during the study and for 1 week following the study treatment.
7. Psychiatric illness/social situations that would interfere with compliance with study requirements.
Context Sensitivity in Emotion Regulation in Post-Traumatic Stress Disorder

This study will examine context sensitivity, composed of two sequential elements: (a) accurate classification of changing affective contextual demands, followed by (b) flexible selection of regulatory strategies that matches changing contextual demands, among complex PTSD vs. Healthy controls.

The study will recruit adults with posttraumatic stress disorder (PTSD) due to a repetitive inter-personal trauma and healthy adult controls which do not meet DSM-5 criteria for PTSD and do not meet the clinical cutoff of Anxiety and Depression screening questionnaires.

A compatibility check, filtering, verification of exclusion criteria and informed consent will occur via online self-report questionnaires.

Clinical questioners include:

Life event Checklist (LEC) - PTSD criteria A Post-trauma Checklist for DSM-5 (PCL) - PTSD symptoms Patient Health Questionnaire (PHQ-9) - Depression Symptoms General Anxiety Disorder Questioner (GAD-7) - Anxiety Symptoms

Participants who pass the initial filtering, will be called and provided with an explanation about the study following which they received the online experiment.

Modified regulatory selection flexibility paradigm- included 3 blocks:

(A) Stimuli Classification- 80 emotional words (equally distributed between high or low intensities) are presented and participants are asked classify each emotional word to high or low intensity.

(B) Regulatory Selection- 40 emotional words (out of the 80 presented in block A) are presented and participants are instructed to behaviorally choose between distraction and reappraisal.

(B) Regulatory Selection- 40 emotional words (the 40 remaining from block A) are presented, prior to regulatory selection, participants received accurate normed intensity classification of the word and then participants are instructed to behaviorally choose between distraction and reappraisal.

Eligibility Criteria:
Inclusion Criteria:

* Native Hebrew speakers
* age between 18 - 65
* normal or corrected to normal vision
* computer and internet access
* Group 1: Diagnosis of PTSD according to the DSM-5
* Group 2: GAD and PHQ scores (score\<10), no diagnosis of PTSD according to the DSM-5

Exclusion Criteria:

* Psychosis
* substance dependence or abuse other than nicotine
* Neurological condition
Evaluation of the Cost-Effectiveness and Sensitivity of Automatic Analysis Versus Manual Analysis of Polygraphy in the Diagnosis of Obstructive Sleep Apnea.

Obstructive sleep apnea (OSA) is a chronic pathology that affects more than 20% of the adult population. It is one of the main sleep disorders with great clinical, economic and social repercussions.

To assess the impact and severity of obstructive sleep apnea, the number of apneas and hypopneas per hour (AHI) is counted. To define that a person has OAS, a sleep study must have an AHI ≥15/h, predominantly obstructive, or the presence of an AHI ≥5/h accompanied by symptoms.

The diagnosis of certainty or exclusion, as well as the severity, is established with a sleep study. Polysomnography (PSG) continues to be the gold standard for the diagnosis of OSA, it encompasses the recording of cardiorespiratory and neurophysiological variables, which makes it possible to analyze sleep time and structure, the presence of different respiratory episodes and their repercussions. Respiratory polygraphy (RP) includes recording from a flow sensor, respiratory effort, oxygen saturation, heart rate, and also position but not EEG. There are several studies that have explored the diagnostic agreement of RP versus PSG, being a validated, useful and necessary test for the diagnosis of OSA in different clinical situations. Being cheaper and more accessible.

When talking about the diagnosis of OSA, it refers to establishing whether or not there is, the severity and the therapeutic decision that will greatly affect the quality of life, prognosis and day-to-day life of the patient, since it is a chronic disease.

It must be borne in mind that most studies are carried out in a field specialized in dream interpretation, so caution must be exercised in interpreting results in another field. PR teams incorporate increasingly better developed software that allows automatic analysis of records, but the technology and algorithms used vary depending on the device, and up to now the AASM continues to recommend manual analysis based on existing evidence. Several studies have examined the agreement between automatic and manual analysis of the PR record or between automatic analysis of PR and PSG. It seems that this agreement is reached above all in the highest AHIs, above 25-30, which may limit its use in clinical practice.

For this reason, it is important to carry out a study with a large number of patients to achieve statistical significance, and strong conclusions that support normal clinical practice, and to disable a study that does not meet the scientific requirements when interpreting and reading.


Eligibility Criteria:
Inclusion Criteria:

* Respiratory polygraphs carried out at the San Pedro Hospital in the period of time between 2014-2020.
* Polygraphs corresponding to patients over 18 years of age.

Exclusion Criteria:

* Poor technical quality of polygraphy
* Patients with \>50% central apnea or presence of Cheyne-Stokes respiration (CSResp).
* Lack of automatic and/or manual analysis of the polygraph.
Investigating Program of Food Preparation on Diet Improvement for Patients With Stroke

This is a randomized controlled behavioral intervention trial to assess the efficacy of investigating program of food preparation on diet improve patients with stroke.

This is a randomized controlled behavioral intervention trial to assess the efficacy of investigating program of food preparation on diet improve patients with stroke. Subjects will be randomized to intervention group and control group.The primary outcome included seven measures, Functional oral intake scale, Mini Nutritional Assessment, Council on Nutrition Appetite Questionnaire, Dietary Well-Being Scale, Swallowing Quality of Life questionnaire, WHO Quality of Life-BREF and Eating Assessment Tool-10.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis is stroke
* EAT-10 ≥ 3
* Aged \> 20 years
* Capability of following instructions
* Willing to participants to the study

Exclusion Criteria:

* Non-stroke neurological diseases ( ex: traumatic brain injury, brain tumor, neurodegenerative disease and Parkinson's disease )
* Dysphagia by neck injury or surgery
* During the study, he/she was hospitalized again due to disease.
Autologous Tenocyte Implantation in Patients With Chronic Achilles Tendinopathy

This study is designed to compare the treatment of 2 groups in patients with Achilles tendinopathy: autologous tenocytes injection in combination with exercises versus saline injection in combination with exercises

Overuse injury of the Achilles tendon is a common entity. When the exact origin of tendon pain is unclear, the term tendinopathy is preferred. Most accepted treatment at this moment is an eccentric exercise programme, according to the Dutch guidelines. However, a recent systematic review on the effectiveness of eccentric exercises to treat lower extremity tendinoses concluded that it is unclear whether eccentric exercises are more effective than other forms of treatment. Recent studies described new treatment strategies in tendinopathies, such as the use autologous Tenocyte Implantation (ATI). This treatment option can participate actively in tissue repair processes on cell level. The only published clinical pilot study in tendon research reported 60% improvement in all scores after 6 months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Pain on palpation 2-7 cm proximal from the tendon insertion ("midportion")
* Symptoms \> 2 months
* Age 18-55 years

Exclusion Criteria:

* Clinical suspicion of insertional disorders , Achilles tendon rupture, plantar flexor tenosynovitis, sural nerve pathology, peroneal subluxation
* Condition of the Achilles tendon caused by medications such as quinolones and statins
* Known to have the following disorders: spondylarthropathy, gout, hyperlipidemia, rheumatoid arthritis and sarcoidosis.
* Antibiotics allergy (aminoglycoside group)
* A condition that prevents the patients from executing an active rehabilitation programme
* Patient has received an injection for this injury
* Patient has received surgical intervention for this injury
* Patient has already one site (left or right) included in this study
* Patient does not wish, for whatever reason, to undergo one of the two treatments
* Known pregnancy
* Nursing women
Changes in Cerebral Blood Flow in Patients Treated With Spinal Cord Stimulation for Low Back and Leg Pain

The primary objective of this study is to identify the brain regions in which activity is affected by SCS. Baseline cerebral blood flow scans with the device turned off will be generated compared to scans produced with the device operating at parameters which produce optimal coverage of the painful areas. The relationship between cerebral blood flow and pain rating scores will be evaluated in both conditions.

Spinal Cord Stimulation (SCS) is known to be effective in pain management. Some evidence exists that SCS may cause changes in cerebral blood flow. This study will be a novel PET examination of activity in brain regions affected by SCS. This activity will be compared with the pain intensity and distribution. Further, by examining cerebral blood flow at different doses of stimulation, relationships between SCS, brain perfusion, and pain relief can be drawn. This study will contribute to the elucidation of the mechanism of action of SCS.

Eligibility Criteria:
Inclusion Criteria:

* Have had one or more back surgery procedures.
* Have used an active Precision SCS device for chronic low back and bilateral leg pain for at least 6 weeks.
* Have bilateral leg pain.
* Have a baseline VAS of \>4 (without stimulation).
* Have greater than 50% reduction in pain with SCS at optimal settings
* Be 18 years of age or older.
* Have the cognitive and functional capability to operate the controls for the device, to comply with directions during the study, and willing to participate in all study activities.
* Be capable of reading and understanding patient information materials and giving written informed consent.

Exclusion Criteria:

* Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.
* Have undergone a surgical lead revision or had any Precision components replaced after initial implantation.
* Are allergic to any of the injected media.
* Are pregnant or lactating.
* Have any contraindication to the PET scan procedure itself or exposure to the intravenous radioactive tracer (H215O).
* Have participated in any drug or device trial in the last 4 weeks or are currently participating in another drug or device trial.
Prevalence of Familial Hypercholesterolaemia (FH) in Italian Patients With Coronary Artery Disease

Evaluate the prevalence of familial hypercholesterolemia (FH) in patients with documented coronary artery disease (CAD) event \[acute myocardial infarction (AMI), acute coronary syndrome (ACS), coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI)\] followed by 100 cardiological centers representative of the whole Italian territory

Familial hypercholesterolemia (FH) is a disease that causes exposure to elevated plasma levels of LDL cholesterol (LDL-C, low-density lipoprotein) and increasing the risk of premature coronary heart disease (coronary artery disease, CAD). The FH is a co-dominant genetic disease and can occur in heterozygous and homozygous form, with different severity. The prevalence in whites is estimated to be 1.500 for heterozygous familial hypercholesterolemia (HeFH) and 1.1000000 for homozygous familial hypercholesterolemia (HoFH). This prevalence is probably an underestimate, as it is based on prevalence rates in in-patient and disease registries, and is influenced by the early mortality of patients with FH. The situation does not improve if we consider patients admitted for acute coronary event (myocardial infarction - AMI and / or unstable angina, - ACS). If we consider LDL cholesterol cumulative load in a person affected by FH, the best approach intervention to reduce cardiovascular mortality is an early diagnosis and treatment.

The primary aim of the study is to evaluate the prevalence of FH in patients with documented CAD event (AMI, ACS, CABG or PCI) followed by 100 cardiologic centers representative of the whole Italian territory. The results will also permit to increase the cardiologists awareness of FH. Secondary objective will be the validation of Dutch Lipid Clinic Network (DLCN) criteria (annex 1), in the Italian CAD population (12). The characterization of the patients, carried out during the study, will allow to identify the priorities for health inteventions aimed at improving the FH diagnosis in the general population through the a cascade screening in the relatives of the genetically characterized subjects.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a documented coronary artery disease, more precisely:

ACS PCI CABG The index event must be occurred between 15 days and 8 weeks preceding the enrollment.

- Written informed consent to participate to the study

Exclusion Criteria:

* Patients unwilling to give their written informed consent.
A Study to Evaluate the Efficacy and Safety of PF-06700841 in Subjects With Active Psoriatic Arthritis

This is a 52 week Phase 2b study designed to evaluate the efficacy at 16 weeks and to evaluate the safety and efficacy up to 1 year in subjects with active psoriatic arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Active arthritis at screening/baseline as indicated by \>/= 3 tender/painful and 3 swollen joints.
* Active plaque psoriasis at screening and baseline.

Exclusion Criteria:

* Non-plaque forms of psoriasis (with exception of nail psoriasis).
* History of autoimmune rheumatic disease other than PsA; also prior history of or current, rheumatic inflammatory disease other than PsA.
Eptinezumab in Healthy Japanese Subjects

The purpose of this study is to investigate how eptinezumab enters, moves through and exits the body. Safety and tolerability will also be investigated.

The study will consist of 18 healthy Japanese subjects, divided into two single dose cohorts with 9 subjects in each cohort.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese subjects with a BMI of ≥ 18.5 and ≤ 25 kg/m2

Other in- and exclusion criteria may apply