cyrilzakka/clinical-trials huggingface dataset:
Study of Pembrolizumab With or Without Defactinib Following Chemotherapy as a Neoadjuvant and Adjuvant Treatment for Resectable Pancreatic Ductal Adenocarcinoma

This study will test the effectiveness (anti-tumor activity), safety, and ability to increase the body's immune system to fight pancreatic cancer by combining standard chemotherapy before and after surgery, with study drug PD-1 antibody, pembrolizumab, with and without study drug, focal adhesion kinase inhibitor (FAK), defactinib, in people with "high risk" resectable (surgically removable) pancreatic cancer. The purpose of this study is to evaluate if reprograming the tumor microenvironment by targeting FAK following chemotherapy can potentiate anti-programmed death-1 (PD-1) antibody.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years.
* Has pancreatic ductal adenocarcinoma
* Has resectable disease at the time of diagnosis
* Has not received any systemic therapy for pancreatic ductal adenocarcinoma
* Has stage ≤ IIb disease at time of diagnosis and enrollment
* Elevated tumor marker, CA (carbohydrate antigen) 19-9 \>200
* ECOG performance status 0 or 1
* Patient must have adequate organ function defined by the study-specified laboratory tests.
* Must use acceptable form of birth control while on study.
* Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

Patients who have received any prior chemotherapy, radiotherapy or investigational agents for pancreatic cancer.

* Patients who have received prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).
* Has received prior therapy with FAK inhibitor.
* Woman who are pregnant or breastfeeding.
* Have received a live vaccine or live-attenuated vaccine within 30 days prior to study drug.
* Is currently or has participated in another investigational study within 4 weeks prior to receiving study drug.
* History or current use of immunosuppressive medications within 7 days prior to study medications.
* Has a known additional malignancy that is progressing or has required active treatment within the past 2 years or that is expected to require active treatment within two years.
* Has active autoimmune disease that has required systemic treatment in the past 2 years.
* Has a history of (non-infectious) pneumonitis/interstitial lung disease or current pneumonitis.
* Has an active infection requiring systemic therapy.
* Infection with HIV or hepatitis B or C.
* Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Known allergy or hypersensitivity to the study drugs.
* Received any growth factors including, but not limited to, granulocyte-colony stimulating factor (G-CSF), GM-CSF, erythropoietin, within 14 days of study drug administration.
* Has history of any organ transplant, including corneal transplants.
Pediatric Anxiety Intervention With an Entertaining Video Game: Feasibility Study

This research study aims to test the feasibility and effectiveness of using an entertaining video game as an addition to traditional therapy for the treatment of anxiety disorders in youth, particularly those youth who may have limited access to mental health treatment in the traditional clinical setting.

The purpose of this research is to learn whether or not youth with social anxiety find a therapeutic video game engaging and useful. Children between the ages of 7 \& 17 who have been diagnosed with a social anxiety disorder will be invited to participate in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Age 7 to 17
2. Primary diagnosis of:

   1. social phobia,
   2. separation anxiety disorder
3. A parent or other primary care giver available to participate with the child in all assessment and treatment activities
4. Estimated average intelligence
5. English speaking
6. Received les than 3 treatment sessions for social anxiety disorder

Exclusion Criteria:

1. History of and/or current diagnosis of:

   1. psychosis,
   2. autism,
   3. bipolar disorder,
   4. mental retardation,
   5. oppositional defiant disorder,
   6. PTSD,
   7. selective mutism, or
   8. major depressive disorder
2. Current suicidality or recent suicidal behavior
3. Parent to be involved in study who is unable to adequately participate due to intellectual or psychiatric difficulties
4. Starting or changing the dosage of a psychiatric medication in the last two months
Retrospective and Prospective Evaluation of Scapulohumeral Comfort, Aesthetic Result and Quality of Life

The dorsalis major flap is an interesting therapeutic option in breast reconstruction because of reliability and reproducibility.

In recent years, the minimal flap technique has been developed, which consists of removing only a portion of the of the large dorsal muscle to reduce the painful and functional sequelae of this surgery.

The objective of this prospective study is to evaluate the functional and aesthetic results in patients who have undergone who have undergone this procedure (prospective cohort) or who will undergo this procedure or prosthetic reconstruction (prospective cohort).

The investigators also wish to evaluate the quality of life of patients after reconstruction with a minimal harvest dorsalis flap or a prosthesis or prosthesis in the prospective cohort.

Retrospective Cohort :

* Clinical data reconstruction and follow-up up to 1 year
* DASH questionnaire
* Breast Q
* aesthetic evaluation (patient and surgeon and other health professional)

Prospective Cohort :

* Clinical data reconstruction and follow-up up to 1 year
* DASH questionnaire (pre-op, at 6 month and at 12 month)
* Breast Q(pre-op, at 6 month and at 12 month)
* aesthetic evaluation (patient and surgeon and other health professional) (at 6 month and at 12 month)

Eligibility Criteria:
Inclusion Criteria:

1. Patients with a desire for breast reconstruction
2. Indication for mastectomy or with a history of mastectomy, with or without preservation of the skin skin,
3. Breast reconstruction procedure by LDPM performed between January 2017 and September2021, (retrospective cohort )
4. Breast reconstruction procedure by LDPM or by prosthesis performed from February 2022 (prospective cohort)
5. Information to the patient and collection of her non-opposition
6. Affiliation to a social security system, or beneficiary of such a system

Exclusion Criteria:

1. Performance of a breast reconstruction by a technique other than LDPM or prosthesis
2. Patient opposed to the use of her data for research
3. Person in an emergency situation, adult subject to a legal protection measure (adult under guardianship, curatorship or safeguard of justice), or unable to express his consent,
4. Impossibility to submit to the medical follow-up of the trial for geographical, social or psychological psychological reasons.
Acute Porphyria Biomarkers for Disease Activity

The long term objective of the research is to identify new biomarkers of disease activity in the human acute porphyrias. This pilot study is intended to provide pilot and feasibility data needed to plan larger and more definitive future studies.

This translational pilot research is based on preliminary results using animal models. The investigators will collect samples of blood, urine and feces from up to 50 participants with well documented acute porphyrias, at 2 expert sites that are members of the Porphyrias Consortium. Collection and analysis of these samples will be used to assess feasibility of performing such studies in humans with acute porphyrias, recognizing that these disorders are more heterogeneous than reproduced in animal models, and affect individuals who cannot all be studied simultaneously and in large groups. Therefore, we will assess the feasibility of methods for collecting, processing, storing and shipping samples at multiple study sites for later biomarker analysis. Larger and more definitive studies of biomarkers will be designed and implemented based on data and experience from this pilot-feasibility study.

Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of acute porphyria.

  1. For AIP: Elevation in urine PBG, with normal or only slight increases in plasma and fecal porphyrins. Most (\~90%) will have deficient activity of erythrocyte PBGD.
  2. For HCP: Elevation in urine PBG, with substantial increases in fecal porphyrins (almost entirely coproporphyrin III). In the absence of skin photosensitivity, most will have normal or only slight increases in plasma porphyrins.
  3. For VP: Elevation in PBG, with substantial increases in fecal porphyrins (mostly coproporphyrin III and protoporphyrin), increased plasma total porphyrins and a fluorescence emission maximum of diluted plasma at neutral pH near 626 nm.

Exclusion Criteria:

* Another medical condition that might confound the results, as judged by the investigator
Mycophenolate Mofetil Versus Cyclosporin A in the Treatment of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Due to Nonresponse to Standard Therapy

Biochemical response of primary biliary cholangitis-autoimmune hepatitis overlap syndrome induced by mycophenolate mofetil versus cyclosporin A


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18-70 years;
2. Diagnosed with PBC-AIH overlap syndrome according to Paris criteria;
3. Patients have a nonresponse to azathioprine;
4. The WBC count ≥2.5x10\^9/L and platelet count ≥50x10\^9/L.
5. Agreed to participate in the trial, and assigned informed consent;

Exclusion Criteria:

1. The presence of hepatitis A, B, C, D, or E virus infection;
2. Patients with presence of serious decompensated cirrhosis;
3. Patients have a history of glucocorticoid or immunosuppressant medication before enrollment;
4. Liver damage caused by other reasons: such as primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver disease or Wilson's disease.
5. Pregnant and breeding women and women of childbearing age in need of reproduction
6. Severe disorders of other vital organs, such as severe heart failure, cancer;
7. Patients with presence of renal insufficiency;
8. Parenteral administration of blood or blood products within 6 months before screening;
9. Recent treatment with drugs having known liver toxicity;
10. Taken part in other clinic trials within 6 months before enrollment.
11. Patients who are allergic to these drugs;
12. Uncontrolled infection and hypertension ;
Prolonged Popliteal Fossa Nerve Blockade (Prolonged Pop)

This study looks at addition of medications to the local anesthetic for the nerve blockade.

Following major foot and ankle surgery patients complain of severe pain. Currently, Hospital for Special Surgery (HSS) usually uses nerve blocks (injections of local anesthetic near nerves supplying the lower leg) to help manage pain after this type of surgery. Patients also receive additional pain pills, including narcotics as needed. This study looks at addition of medications to the local anesthetic for the nerve blockade. The investigators hope that these medications (dexamethasone and buprenorphine) will prolong the pain relief from the nerve block. There are 3 groups in the study. One group is a control, and receives usual therapy: nerve block + pain pills. This is typically what the patient would receive as standard care if they were not in the study. One group uses a nerve block with additives (+ pain pills). One group gets a nerve block (local anesthetic only) + pain pills + intravenous buprenorphine - this is meant to see if the buprenorphine acts directly on the nerve that was blocked, or indirectly acts on the brain.

Patients will be followed while in the hospital, and contacted by telephone and/or email after discharge for 2-3 days. Patients will be asked about their pain levels and the duration of their block. The investigators will enroll 90 patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients of Dr. Levine or Dr. Roberts at Hospital for Special Surgery
* Patients aged 18-75
* Patients scheduled for discharge from HSS after foot or ankle surgery
* A single-injection popliteal fossa nerve block is judged appropriate
* Surgery confined to foot and ankle (no iliac crest bone graft planned - iliac aspirate is not an exclusion criterion)

Exclusion Criteria:

* \< 18 and \> 75
* Surgery that will cause pain at sites outside the distal lower extremity (e.g. iliac crest bone graft)
* Bilateral surgery
* Chronic pain (defined as regular use of opioid analgesics for \> 3 months)
* Chronic use of steroids (defined as regular use of steroids for \> 3 months)
* Contraindication to performance of the popliteal fossa nerve block with 30 cc 0.25% bupivacaine (e.g. alleged bupivacaine sensitivity, low body weight, etc.)
* Contraindications to dexamethasone or buprenorphine (e.g. allergy, insulin dependent diabetes mellitus, etc.)
* Patients who have been diagnosed with altered pain perception or have lack of sensation
* Inability of the patient to describe postoperative pain (e.g. psychiatric disorder, dementia)
* Non-English speaking patients (the questionnaire is in English, and translations would have to be separately validated)
French Language Validation of the 5-minutes Montreal Cognitive Assessment (MoCA)

The aim of the study is to validate a french version of the 5 minutes version of the Montreal Cognitive Assessment as compared to the french full version of this test.

The Montreal Cognitive Assessment (MOCA) is a test used to detect cognitive impairments. This test is available in different languages including french. A short version (the 5 minutes MOCA) has also been validated through a phone call use that allows to develop some epidemiological approaches. Nevertheless, this short version has not been validated in french.

The main aim of the study is to validate the french translation of the short version of the MOCA as compared the the full french version of the test.

To validate the short version, several groups of subjects will be included : healthy subjects, Alzheimer disease patients, Parkinson or Huntington diseases patients as well as diabetic patients.

The inclusion of both healthy subjects and patients with different types of cognitive impairments will allow to validate the short version of the test.

All subjects and patients will first be submitted to the full version of the MOCA during a face to face procedure. Thirty to forty days later, they will be submitted to the short version of the test through a phone call performed by an independent rater.

Subgroups of healthy subjects and patients will also be used to determine the test-retest and inter-rater reliability of the short version of the MOCA.

Eligibility Criteria:
Inclusion Criteria:

Healthy Volunteers

* Volunteers, BMI \<26
* free from neurological, psychiatric, metabolic or cardiac pathologies;
* Absence of active metabolic or cardiac diseases, unstabilized under treatment
* Pregnant test negative

Patients

* Patients suffering from pathologies that may be accompanied by cognitive decline or dementia (Alzheimer's disease, Parkinson's and Huntington's disease, diabetes) that meet the usual diagnostic criteria for these diseases;
* Patients should not start treatment of a new therapeutic class under test

Exclusion Criteria:

* Pregnant or nursing women.
* Illiterate subjects
* Presence of uncorrected visual or auditory disturbances
* "Alcohol use disorder" observed at the Mini International Neuropsychiatric Inventory (MINI);
* "Substance use disorder" observed at the MINI;
* Participation in a therapeutic trial or in an exclusion period from a previous clinical trial;
* Patient whose physical or mental condition does not allow them to pass the study tests;
* Persons under guardianship or under trusteeship;
* Recent cognitive assessment (less than 6 months) by the classic MoCA
Ameliorating the Obstacle of Pap Smear

To reduce the procedural pain of Pap smear, this study expects to apply the peak-end rule to Pap smear by prolonging the insertion of speculum after samples are obtained from the cervix. This study aims to conduct a randomized controlled study at a tertiary center, National Taiwan University Hospital (NTUH). The investigators expect to compare the recalled pain intensity of the intervention and control groups.

Purpose: In order to reduce the procedural pain, this study expects to apply the peak-end rule to Pap smear by prolonging the insertion of speculum after samples are obtained from the cervix. Methods: This study aims to conduct a randomized controlled study at NTUH. Approximately 200 subjects are expected to be recruited. The investigators will utilize the peak-end rule by adding a non-painful step right after the most uncomfortable phase in the intervention group. All study subjects are requested to score on a numeric pain scale during the Pap test. All operators experienced in techniques for performing a Pap test should attend workshops for a standard operating procedure. A well-trained research assistant is also responsible for ensuring standardization of procedures to eliminate interoperator variability. The primary outcome was the recalled pain intensity at five minutes after the Pap smear test.

Eligibility Criteria:
Inclusion Criteria:

* Biological female
* Aged 30-70
* Provision of written informed consent

Exclusion Criteria:

* Pregnancy
* Active vaginal or uterus infection
* Incapable of understanding the numeric pain scales
* Prior cervical cancer diagnosis
* Prior hysterectomy, pelvic or vaginal surgery
* Ongoing menstruation
* Use of painkillers within 24 hours
Single Dose Escalation Study of PF-04360365 In Subjects With Mild To Moderate Alzheimer's Disease

The purpose of this study is to determine whether single doses of PF-04360365 is safe and well tolerated in patients with Alzheimer's Disease.


Eligibility Criteria:
Inclusion Criteria:

* Male or female (of non-child bearing potential) subjects ages ≥50 years of age.
* Diagnosis of probable AD (of mild to moderate severity), consistent with criteria from both: NINCDS-Alzheimer's Disease and Related Disorders Association (ADRDA) and DSM-IV-TR.
* MMSE score of 16-26 inclusive.
* Rosen-Modified Hachinski Ischemia Score ≤4.
* On a stable dose of background cholinesterase inhibitors or memantine for at least 60 days prior to dosing.

Exclusion Criteria:

* Diagnosis or history of other dementia or neurodegenerative disorders.
* Diagnosis or history of clinically significant cerebrovascular disease.
* Specific findings on magnetic resonance imaging (MRI); cortical infarct, micro hemorrhage, multiple white matter lacunes.
* History of allergic or anaphylactic reactions.
Study to Evaluate the Safety and Preliminary Efficacy of IDCT, a Treatment for Symptomatic Lumbar Disc Degeneration

The purpose of this study is to compare the safety and preliminary efficacy of intradiscal injections of two doses of IDCT (Discogenic Cells + Sodium Hyaluronate vehicle) and one sham control in subjects with chronic low back pain due to Degenerative Disc Disease (DDD) at one lumbar level from L3 to S1.

This is a Phase I/II, randomized, double-blind, sham-controlled, parallel-group, multi-center study in subjects with single-level, symptomatic lumbar intervertebral disc degeneration (\>6 months) and unresponsive to conservative therapy for at least 3 months. The study will compare single intradiscal injections of high and low dose IDCT with one sham control group.

6 study visits will be completed by all subjects; screening, day 1 (injection day), week 4, week 12, week 26 and week 52. The subject will be assessed for safety and efficacy utilizing VAS, ODI and JOABPEQ questionnaires alongside radiographic evaluations. The study will have a 6 month follow-up and a 6 month extension period (total 1 year).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of early to moderate degenerative disc disease (DDD), Modified Pfirrmann Grade 3-7.
* Chronic low-back pain for at least 6 months prior to screening; unresponsive to at least 3 months of conservative care.
* Low-back pain of 40 to 90 mm on the VAS
* ODI score of 30 to 90.

Exclusion Criteria:

* Symptomatic involvement of more than one lumbar disc.
* Other persistent pain/nerve issues including, for example, radiculopathy, leg pain, Cauda Equine syndrome, etc.
* Fracture of the spine, previous lumbar spine surgery or previous treatment of the target disc.
* Evidence of dynamic instability on lumbar flexion-extension radiographs.
* Grade 2 or higher spondylolisthesis at the target disc, lumbar spondylitis or other undifferentiated spondyloarthropathy, or Type III Modic changes around the target disc.
* Clinical suspicion of a full thickness annular tear at the target disc or other abnormal disc morphology.
* Subjects who test positive for communicable disease, have significant systemic disease, or are prone to infection.
* Patients who are deemed unsuitable for clinical study participation by the investigator.
Efficacy of Intra-articular Injection of Human Amniotic Suspension Allograft and Platelet-rich Plasma in the Treatment of Knee Osteoarthritis.

A double-blind, randomized controlled trial designed to evaluate the symptomatic modulating efficacy of amniotic suspension allograft (ASA) in comparison to platelet-rich plasma (PRP), hyaluronic acid (HA) and normal saline (NS) in the injection treatment of knee osteoarthritis. The hypothesis is that ASA would provide the greatest functional improvement.

At least 150 subjects with osteoarthritic knee will be recruited and computer randomized 1:1:1:1 to single injection of ASA (40mg), ASA (20mg), PRP + HA, and NS groups. Both subjects and evaluaters were blinded to allocations. Functional and radiologic outcomes were measured at baseline, and 1 week, 1, 3, 6, 12 months postinjection.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 80 years
* Ability to provide informed consent
* Unilateral or bilateral knee VAS pain score ≥ 4 of 10 (worst possible pain) for more than 4 months
* Diagnosis of OA Kellgren-Lawrence I-III by radiography (triple-film of bilateral lower limb, standard knee anterior-posterior view in full extension, lateral view in 30-degrees flexion, and 45°Merchant views)
* No prior PRP injection of knee
* No prior surgical procedure of the participating knee
* BMI\<40 kg/m2

Exclusion Criteria:

* Lawrence stage IV
* Major axial deviation (varus\> 5°, valgus \> 5°)
* Any concomitant symptomatic knee disorder (i.e. ligamentous/ meniscal injury)
* Systemic inflammatory arthropathy
* Hematologic diseases
* Severe cardiovascular disease
* Neurological disorders
* Active infection
* Immuno-compromised
* Therapy with anticoagulants or antiaggregants
* Use of NSAIDs and/or chondroprotective supplements, such as glucosamines and chondroitin sulfates, within 7 days prior to trial
* Recent intra-articular injection of corticosteroids (within 30 days)
* Prior treatment with HA in past 6 monthsHb\< 11 g/dL
* Platelet count \< 150,000/mm3