cyrilzakka/clinical-trials huggingface dataset:
Automatic Multimodal Assessment of Occurrence and Intensity of Pain for Research and Clinical Use

170 patients with rotator cuff syndrome will be filmed abducting and flexing their arms before learning a simple maneuver that alleviates most of the pain 90% of the time. They will then be filmed performing the same abduction and flexion of their arms. The patients will rate their pain on the common 10-point pain scale after abducting and flexing their arms before and after the maneuver.

Facial expression and truncal metrics correlate strongly with occurrence and intensity of pain. Rotator cuff syndrome almost invariably gives significant pain, especially with abduction and flexion of the arms. A simple maneuver that alleviates that pain 90% of the time, by activating the subscapularis to perform the function of the damaged supraspinatus muscle. This study strives to correlate facial and truncal characteristics with the ten-point pain scale by correlating the filmed changes in facial and truncal characteristics with the variations in patient-rated pain before and after the pain-controlling maneuver.

Once effective, the maneuver may be repeated for a number of days, after which time patients generally remain pain-free permanently.

Eligibility Criteria:
Inclusion Criteria:

Rotator cuff syndrome -

Exclusion Criteria:

Psychological or emotional instability

Other orthopedic conditions of the shoulders

Cosmetic facial surgery

-
Menstrual-phase-dependent Differences in Response to Sleep Loss

This study is designed to assess how healthy premenopausal women respond to different patterns of sleep loss at different times in the menstrual cycle.

During a 1.5-week inpatient laboratory protocol, participants will undergo one of two parallel sleep conditions during either the follicular or luteal phase of the menstrual cycle (4 study arms total). Subjects will be randomly assigned to each study arm. During their time in the laboratory, biological samples (e.g., blood) will be collected for assessment of sex steroid hormones and other analyses. Sleep quantity and quality will be monitored and responses on neurobehavioral tests and surveys will be monitored for differences across conditions.

Eligibility Criteria:
Inclusion Criteria:

* Female
* 18-35 years old
* Regular menstrual cycle between 26-35 days in duration
* Not using any form of hormonal contraception for at least the prior 3 months
* Regular sleep patterns (7-9 hours/night)
* Not taking any medications or supplements
* Weight \>110 lb
* BMI between 18.5 and 29.5 kg/m2

Exclusion Criteria:

* Primary sleep disorder
* History of shift work
* Transmeridian travel in the previous 3 months
* Presence of acute or chronic disease, including but not limited to: diabetes, metabolic disorders, psychiatric illness, reproductive disorders
* Current pregnancy, \< 6 months postpartum, and/or breastfeeding
* Blood donation in the past 8 weeks
* Extreme morning or evening chronotype
Study of OP-3136 in Advanced or Metastatic Solid Tumors

This is a first-in-human, open-label, multicenter phase 1 study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of OP-3136, a lysine acetyltransferases 6A and 6B (KAT6A/B) inhibitor, in participants with advanced solid tumors.

This study consists of 2 parts: a dose escalation part (Part 1) and dose expansion part (Part 2).

Part 1 (Dose Escalation): This part of the study will evaluate the safety, tolerability, and PK in a range of doses of OP-3136, a lysine acetyltransferases 6A and 6B (KAT6A/B) inhibitor, administered orally once daily to participants with ER+ HER2- advanced or metastatic breast cancer (mBC), advanced or metastatic castration resistant prostate cancer (mCRPC), or advanced or metastatic non-small cell lung cancer (mNSCLC), and determine the maximum tolerated dose (MTD) and the recommended dose/regimen for expansion (RDE).

Part 2 (Dose Expansion): This part will evaluate the recommended dose and regimen from Part 1 in the expansion cohorts of participants with ER+ HER2- mBC and participants with mCRPC.

Eligibility Criteria:
Key Inclusion Criteria:

* Participants with advanced or metastatic ER+HER2- breast cancer, mCRPC, or NSCLC (Part 1) or advanced or metastatic ER+HER2- BC or mCRPC (Part 2).
* Part 1 (Dose escalation): Participants must have a tumor that is unresectable or metastatic and for which life prolonging measures do not exist or available therapies are intolerable or no longer effective.
* Part 2 (Dose Expansion in ER+ HER2- mBC): Participants must have received up to 3 prior lines of endocrine therapy (one of which must be in combination with CDK4/6 inhibitor) and up to 1 prior line of chemotherapy or an antibody-drug conjugate.
* Part 2 (Dose Expansion in mCRPC): Participants must have received up to 4 lines of prior systemic therapy for prostate cancer. Prior therapy must include treatment with an androgen receptor pathway inhibitor(s).

Key Exclusion Criteria:

* Prior therapy with KAT6A/B inhibitor in any treatment setting.
* Participants with advanced/metastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term.
* Known active or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require CNS-specific treatment, or participants who did not demonstrate clinical and radiologic stability during the last 2 months prior to the first dose of study treatment or require or are currently on steroid therapy for CNS metastases.
* History of cerebral vascular disease, including transient ischemic attack, within 6 months prior to the first dose of study treatment.
* History of or ongoing impaired cardiac function or clinically significant cardiac disease within 6 months prior to the first dose of study treatment.

Note: Additional inclusion/exclusion criteria may apply.
Measurement of Kidney Blood Flow and Oxygen Levels by MRI

Comparison of renal blood flow measurements by PAH clearance and MRI

The traditional measurement of renal blood flow in ml/min involves the collection of multiple blood and urine samples after an infusion of a drug called para-aminohippurate (PAH) is given. In this study, the investigators determine the ability of MRI to estimate renal blood flow. The primary hypothesis is that renal blood flow as measured by PAH clearance is similar to renal blood flow as estimated by MRI. The measurements by PAH clearance and MRI are both performed on the same day.

Eligibility Criteria:
Inclusion Criteria:

In this study, the investigators will enroll 16 men and women aged ≥ 18 years with Stage II - V chronic kidney disease (CKD). In addition, the investigators will enroll 4 subjects with a glomerular filtration rate (GFR) of greater than 60 ml/min who do not have any evidence of CKD.

Exclusion Criteria:

This study excludes those not suitable for MRI or for the interventional pharmacologic procedures.
Healthcare Costs and Resource Utilization in Aimovig Migraine Patients: a Retrospective Study Using United States Claims Data

The proposed study is a retrospective, non-interventional analysis that uses medical and pharmacy claims data in the US from Komodo Health

The proposed study is a retrospective, non-interventional analysis that uses medical and pharmacy claims data in the US from Komodo Health.

Study data included adjudicated and paid medical and pharmacy claims in the US between November 1, 2017 and September 1, 2019 provided by Komodo Health.

Eligibility Criteria:
Inclusion Criteria:

General Cohort

* Adult (18 years or older)
* Newly initiating on Aimovig (no other claims during a 180-day wash-in period)
* Had continuous medical and pharmacy benefit eligibility from 180 days pre-index of Aimovig through 180-days post-index

Primary \& Secondary Objectives Sub-Cohort

- Had 3 consecutive months with a claim for Aimovig (≤15 days gap between days supply and the subsequent claim to be considered consecutive)

Primary \& Secondary Objectives Cost Sensitivity Analyses Sub-Cohorts

* Had continuous medical and pharmacy benefit eligibility from 180 days pre-index of Aimovig through 270-days post-index to permit assessment of cost outcomes (all-cause and migraine-related) during days 91-270 post-index
* Had continuous medical and pharmacy benefit eligibility from 180 days pre-index of Aimovig to the maximum follow-up time post-index with continuous medical and prescription insurance eligibility until the data end date (September 1, 2019)

Exclusion Criteria:

* Patients with any claim for another CGRP-targeted medication (Ajovy or Emgality) during entire study period
Postpartum Heparin Against Venous Thromboembolism: a Pilot Randomized Controlled Trial

In previous attemps to answer the question of risk-benefit of postpartum thromboprophylaxis, researchers were faced with low recruitement rates. The goal of this pilot feasibility randomized controlled trial of postpartum pharmacological thromboprophylaxis is to examine the feasibility (recruitement rate) and participation rate at the Geneva University Hospitals


Eligibility Criteria:
Inclusion Criteria: adult women within 48h of delivery, with:

* ≥2 of the following risk factors Age ≥35 years Pre-pregnancy BMI 30.0-34.9kg/m2 Current smoking Elective cesarean section Postpartum hemorrhage Antenatal immobility
* and/or ≥1 of the following risk factors: Emergency cesarean section Pre-pregnancy BMI ≥35kg/m2 Known low-risk thrombophilia (heterozygous factor V Leiden; heterozygous G20210 prothrombin mutation) Pre-eclampsia Pre-term delivery (\<37th week of gestation) Peripartum systemic infection (defined as fever with use of antibiotics) Intra-uterine growth restriction (birth weight \<5th percentile)

Exclusion Criteria:

* any indication for therapeutic anticoagulation
* a high-risk of postpartum venous thromboembolism (personal history, high-risk thrombophilia)
* an increased bleeding risk
* a contra-indication to the use of heparin
Regulatory B Cells and Chronic Immune Thrombocytopenia

The chronic immune thrombopenia is an autoimmune disease caused by B cells. These cells produce anti platelets and megakaryocytes antibodies. Some B cells, named regulatory B cells, are known to control other cells. Their action in chronic immune thrombopenia is actually unknown.

The chronic immune thrombopenia is an autoimmune disease caused by B cells. These cells produce anti platelets and megakaryocytes antibodies. Some B cells, named regulatory B cells, are known to control other cells. Their action in chronic immune thrombopenia is actually unknown. In our cohort of chronic immune thrombopenia and controls, we realized a flow cytometry analyze of B and T cells and a co-culture to determine regulatory B cells functionality.

Eligibility Criteria:
Inclusion Criteria:

* Purpura, Thrombocytopenic, Idiopathic, chronic phase (\>12 months)
* no treatment or thrombopoietin receptor agonists

Exclusion Criteria:

* \< 18 years
* Purpura, Thrombocytopenic, Idiopathic, acute phase
* pregnancy
* others causes of thrombopenia
Impact of Treatment of Periodontis on Endothelial Function in Patients With Obstructive Sleep Apnea

Evaluation of the add-on effect on endothelial dysfunction of treatment of periodontitis in patients with chronic periodontitis and severe obstructive sleep apnea treated by CPAP. Patients with and without chronic periodontitis will be treated by CPAP for 20 weeks. At V2 (10 weeks), endothelial dysfunction will be assessed by the Reactive Hyperemia- Peripheral Artery Tone index. The endothelial dysfunction of the patients will be also assessed at V3 (20 weeks) after periodontitis treatment for the group of patients with chronic periodontitis.

At V2, patients with periodontitis will have full-mouth intensive removal of denatl plaque biofilms with the use of scaling and root planing. The add-on effect of the periodontitis treatment on endothelial dysfunction will be assessed ten weeks later (V3) in comparison with V2 by taking into account with the effect of 10 weeks of CPAP in the control group with severe OSA but not periodontitis.

Eligibility Criteria:
Inclusion Criteria:

* severe OSA defined by an apnea hypopnea index \> or = 30 per hour
* with or without chronic parodontitis

Exclusion Criteria:

* non equilibrated diabetes
* obesity (BMI \> or = 40)
* active smoker (\> 1 pack per day (20 cigarettes))
* pregnancy
* antibiotics within the preceding three months
* prophylactic antibiotherapy required for the parodontitis treatment
* acute parodontitis or all parontal pathology requiring immediate therapy
* less than 10 teeth
Promoting Sustainable Return to Work Among Employees on Sick Leave Due to a Mental Health Condition: Evaluation of the HealthyMinds Online Group Intervention

The purpose of this clinical trial is to evaluate the impact of an online group intervention called Healthy Minds in facilitating a sustainable return to work for individuals with a mood disorder. The study aims to answer the following key questions :

* Does receiving the Healthy Minds online intervention lead to a more sustainable return to work compared to not receiving the intervention?
* Are the health outcomes (e.g., depressive symptoms) and work-related outcomes (e.g., work functioning) of individuals who receive the Healthy Minds online intervention better than those who do not receive the intervention in the year following the intervention?

Both experimental and control participants will be recruited at baseline while on sick leave (expected to return to work in less than one month) or recently returned to work (less than one month). Participants will complete a series of online questionnaires at the following time points :

* Baseline
* First follow-up (2 months after baseline)
* Second follow-up (6 months after baseline)
* Third follow-up (12 months after baseline)

The questionnaires will cover the following areas :

* Sociodemographic and biopsychosocial factors
* Symptoms associated with the primary mood disorder
* Cognitive difficulties and biaises
* Self-efficacy related to return to work
* Work accommodations and natural supports
* Relationship with immediate supervisor
* Work functioning
* Return to work time (number of days away from work)

Experimental participants will participate in the 2-month online Healthy Minds group intervention (cohort of 5 participants) between the baseline assessment and the first follow-up. The intervention consists of 8 sessions (one per week for 8 weeks), with each session focusing on a specific aspect of the return-to-work process from a cognitive-behavioral perspective.


Eligibility Criteria:
Inclusion Criteria:

* Be in the process of returning to work after depression, anxiety disorder, adjustment disorder (with depressed mood, or anxious mood).

or

* Been back for less than a month

Exclusion Criteria:

* Inability to communicate in French
* Have a known organic disorder
* Have already received CBT-type intervention (group or individual)
Probiotics Therapy of Mood Disorders

The evaluation of the influence of a probiotics therapy on mood improvement and the reduction of depressive symptoms in women in the perimenopausal age group.

The aim: The evaluation of the influence of a probiotics therapy on mood improvement and the reduction of depressive symptoms in women in the perimenopausal age group.

The study hypothesis: By using periodic probiotics therapy it is possible to positively influence the mood of women with depressive syndromes. These efforts focus on the improvement of the functioning of the gut barrier and gut-brain axis. In practice, such activities should lead to the reduction in the dysfunction of the barrier, the reduction of endotoxemia and the concentration of neurotoxic metabolites of tryptophan (in blood) with the simultaneous increase in the content of butyric acid that has a neuroprotective effect.

The of the trial: intervention, cohort, randomized, double-blind, using placebo. A multi-strain probiotic will also be provided ( Bifidobacterium bifidum W23, Bifidobacterium lactis W52, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus casei W56, Lactobacillus salivarius W24, Lactococcus lactis W19 and Lactococcus lactis W58 or maize starch, maltodextrins and vegetable protein/placebo).

The applied method of study:

1. a controlled dietary intervention that includes probiotics therapy; the verification of the past nutritional pattern (the Food Frequency Questionnaire); anthropometric measurements;
2. psychiatric studies: the evaluation of sleep disorders (the Athens insomnia scale) and mood (the Beck scale), and the worsening of depression (the Hamilton scale);
3. biochemical studies: the content of short chain fatty acids (in the stool);
4. cytometric studies (B-type lymphocytes' panel, T-type lymphocytes' panel, regulatory T cells' panel);
5. genetic (the microbiome of bacteria in the stool, pyrosequencing);
6. chromatographic (the derivatives of tryptophan e.g., kynurenine, anthranilic acid, kynureic acid, 3-hydroxykynurenine, 5-hydroxytryptophan, serotonin).

Currently, there is an urgent problem to develop recommendations regarding the nutrition and probiotics therapy that could complement the therapy of women with mood disorders. If the achieved results confirm the study hypothesis, it will be possible to:

1. better understand the pathomechanism of mood disorders in the perimenopausal period;
2. develop a holistic strategy for depressive disorders in women in the menopause period.

Eligibility Criteria:
Inclusion Criteria:

* must presence of mood disorders confirmed by Beck scale (more than 10 points)
* must be able to swallow tablets

Exclusion Criteria:

* individuals that had prescribed antibiotics, proton pump inhibitors, or probiotics in the 6 months preceding the study (eg. inflammatory bowel syndrome)
* circulatory disorders patients
* diagnosed coagulopathies,
* diagnosed respiratory disease
* inflammatory bowel disease patients
* addicted to alcohol
* addicted to psychoactive substances,
Analysis of Postural Transitions in Subjects Affected by Parkinson Disease

This observational trial aims to evaluate the effect of Rehabilitation on Postural Transfers (PTs) in subjects affected by Parkinson Disease. The PTs are evaluated by an inertial sensor (a device composed by an accelerometer, a gyroscope and a magnetometer) attached to the subjects. The data obtained by the inertial sensor are kinematic (e.g. acceleration and angular speed) and spatiotemporal parameters (e.g. time to completion and velocity). Additional clinical evaluations are carried out at the beginning and end of the rehabilitative intervention.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with Idiopathic Parkinson's Disease;
* Subjects should be in a positive therapeutic window or in the ON phase during the evaluations;
* Subjects must be able to walk at least 10 meters independently with or without any walking aid

Exclusion Criteria:

* Non-clinically stable subjects;
* Subjects in OFF phase during the evaluations;
* Other neurological conditions (e.g. stroke, peripheral neuropathies, etc.);
* Other pathologies that can negatively influence the subject's walking ability (e.g. surgery at the lower limbs in the previous 6 months, important deformities at the lower limbs, etc.)
Open Label Continuation Study of TRC105 for Patients Who Have Completed a Prior TRC105 Trial

Open-label, continuation study

This is a multicenter, open-label, non-randomized, study of TRC105 in patients that have completed a previous TRC105 study and are judged by the investigator to have the potential to benefit from continued TRC105 therapy.

Eligibility Criteria:
Inclusion Criteria:

* Participation in a TRACON Pharmaceuticals sponsored parent TRC105 study and, thought to have potential to derive clinical benefit from continued treatment with TRC105 in the opinion of the parent study investigator.
* Willing and able to consent for self to participate in study
* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
* 18 years of age or older
* ability to begin TRC105 dosing on this protocol within 6 weeks from the subjects last dose of TRC105 in the parent TRC105 study

Exclusion Criteria:

* Any clinical event that would make TRC105 therapy inappropriate under the parent protocol
* Current treatment in another clinical study
* Pregnant or breastfeeding
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator, would make the subject inappropriate for entry into the study
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types

The aim of the project is to demonstrate superior detection ratio of \[18F\]AlF-FAPI-74 PET/CT compared to \[18F\]FDG PET/CT or conventional imaging in treatment-naïve, newly diagnosed patients with oesophagogastric adenocarcinoma (clinical T1-4N0-3M0) and pancreatic ductal adenocarcinoma (clinical T1-4N0-2M0-1) and describe the clinical utility of \[18F\]AlF-FAPI-74 PET/CT in oncological patients with a clinically challenging situation.


Eligibility Criteria:
Inclusion Criteria OGA:

1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
2. Age 18 or older.
3. New histologic or cytologic proven diagnosis of oesophagogastric adenocarcinoma.
4. Patient underwent a \[18F\]FDG PET/CT.
5. TNM classification: cT1-4N0-3M0

Inclusion Criteria PDAC:

1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
2. Age 18 or older.
3. New histologic or cytologic proven diagnosis of pancreatic ductal adenocarcinoma.
4. Patient underwent a \[18F\]FDG PET/CT or conventional staging with CT or MRI.
5. TNM classification: cT1-4N0-2M0-1, with the exception of upfront resectable patients.

Inclusion Criteria Clinically challenging cohort:

1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
2. Age 18 or older.
3. Histologic or cytologic proven diagnosis of a malignancy.
4. Patient underwent a \[18F\]FDG PET/CT.
5. Unexplained symptoms, complaints, biochemical or imaging (scintigraphy, PET, CT, MR) findings.

Exclusion Criteria:

1. Participant is mentally or legally incapacitated, doesn't understand the study design or is not willing or capable to undergo all study-specific procedures.
2. Any disorder or condition, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol.
3. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial.
4. Female who is pregnant (urinary hCG test can be performed in case of doubt), breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive (with a relatively high Pearl Index: natural methods, minipill outside postpartum period, spermicides or condoms in monotherapy or no usage of contraception when sexually active are not accepted).
5. Participation in an interventional Trial with an investigational medicinal product (IMP) or device when the trial designs are not considered compatible by the study team.
6. Participation in a clinical scientific study in the last 12 months with a radiation exposure caused by the experimental procedures greater than 1 mSv.
7. Participant has a known hypersensitivity to \[18F\]AlF-FAPI-74 or the used excipients.