cyrilzakka/clinical-trials huggingface dataset:
Intraoperative Monitoring to Predict Postoperative Complications After Thyroidectomy

The goal of this study is to evaluate the role of intraoperative continous and intermittent neuromonitoring and intraoperative parathormone (PTH) to predict postoperative nerve morbidity and hypocalcemia.

Intraoperative PTH values and intraoperative continuous neuromonitoring will be collected prospectively in consecutive patients who undergo total thyroidectomy.

Postoperative parathyroid morbidity and recurrent laryngeal nerve morbidity will be evaluated within 1 week after total thyroidectomy and at 1 year postoperatively.

Other postoperative morbidity will be evaluated at 1 year postoperatively using validated classification.

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for total thyroidectomy in university of Nancy (University Hospital)

Exclusion Criteria:

* refusal to participate
A Phase I, Dose-Escalation Study to Assess the Safety and Drug Levels in Blood of AZD4877 in Japanese Adult Patients

The primary purpose of this study is to evaluate the safety and tolerability of AZD4877 on a weekly schedule in Japanese patients with advanced solid malignancies


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with solid tumour but which have no standard treatment or did not respond to previous treatments.
* Patients who usually have mild symptoms capable of walking and light and sedentary work.
* Patients who can stay in hospital at least during 4 weeks.

Exclusion Criteria:

* Patients who have received treatment with anti-cancer agent within 4 weeks prior to first dose of study treatment; 6 weeks if the anti-cancer agent is mitomycin.
* Patients with abnormally low levels of neutrophil count, platelet count, or haemoglobin, indicators of bone marrow function.
* Patients who received therapeutic radiotherapy at central nervous system within 3 months prior to first dose of study treatment; the other sites within 4 weeks; or local site within 2 weeks.
A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination with Venetoclax/Azacitidine, Venetoclax, or 7+3 in Patients with AML

This Phase 1 study will assess the safety, tolerability, and preliminary antileukemic activity of ziftomenib in combination with venetoclax and azacitidine (ven/aza), ven, and 7+3 for two different molecularly-defined arms, NPM1-m and KMT2A-r.


Eligibility Criteria:
Key Inclusion Criteria:

* Patients must have a documented NPM1 mutation or KMT2A rearrangement and have either newly diagnosed or relapsed/refractory AML
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Adequate liver, renal, and cardiac function according to protocol defined criteria
* A female of childbearing potential must agree to use adequate contraception from the time of screening through 180 days following the last dose of study intervention. A male of childbearing potential must agree to use abstinence or adequate contraception from the time of screening through 90 days following the last dose of study intervention

Key Exclusion Criteria:

* Diagnosis of either acute promyelocytic leukemia or blast chronic myelomonocytic leukemia
* Known history of BCR-ABL alteration
* Advanced malignant hepatic tumor \[for patients receiving ven/aza combination\]
* Administration of live attenuated vaccines within 14 days prior to, during, or after treatment until B-cell recovery
* Active central nervous system (CNS) involvement by AML.
* Clinical signs/symptoms of leukostasis or WBC \> 25,000 / microliter. Hydroxyurea and/or leukapheresis are permitted to meet this criterion
* Not recovered to Grade ≤1 (NCI-CTCAE v5.0) from all nonhematological toxicities except for alopecia
* Known clinically active human immunodeficiency virus, active hepatitis B or active hepatitis C infection
* For newly diagnosed cohorts: received prior chemotherapy for leukemia, except hydroxyurea and/or leukapheresis to control leukocytosis, prior treatment with all-transretinoic acid for initially suspected acute promyelocytic leukemia, or non-HMA therapy for prior myelodysplastic syndrome
* For relapsed/refractory cohorts: received chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy that is considered to be investigational \< 14 days prior to the first dose of ziftomenib or within 5 drug half-lives prior to the first dose of study drug
* Uncontrolled intercurrent illness including, but not limited to, cardiac illness as defined in the protocol
* Mean corrected QT interval corrected for heart rate by Fredericia's formula (QTcF) \>480 ms on triplicate ECGs
* Uncontrolled infection
* Women who are pregnant or lactating
* An active malignancy and currently receiving chemotherapy for that malignancy or disease that is uncontrolled/progressing
A Study to Assess Efficacy and Safety of Filgotinib in Ankylosing Spondylitis

This is a multicenter, Phase 2, double-blind, placebo-controlled study in subjects with active Ankylosing Spondylitis (AS). A total of approximately 100 subjects will be randomized to one of 2 treatment arms in a 1:1 ratio: oral filgotinib tablets q.d. or matching placebo q.d. Treatment duration will be 12 weeks. Each subject will stay in the study for a maximum of 20 weeks (from Screening visit to Follow-up visit).


Eligibility Criteria:
Key Inclusion Criteria:

* Male or female subjects who are ≥18 years of age on the day of signing informed consent.
* Diagnosis of moderate to severe ankylosing spondylitis with documented evidence of fulfilling the Modified New York (NY) criteria
* Have active ankylosing spondylitis with a BASDAI ≥4 (numeric rating scale \[NRS\] 0-10) and spinal pain ≥4 (0-10 NRS) (based on BASDAI question 2, see protocol) at screening and baseline.
* Have had a documented inadequate response to NSAIDs including cyclooxygenase-2 (COX-2) inhibitors.
* If using cDMARD therapy, stable dose for at lead 4 weeks prior to Baseline.
* If using non-drug therapies (including physical therapies), these should be kept stable during screening.
* Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use highly effective methods of contraception as described in the protocol.

Key Exclusion Criteria:

* Use of JAK inhibitors, investigational or approved, at any time, including filgotinib;
* Prior use of more than one TNF inhibitor, at any time.
* Use of oral steroids at a dose \>10 mg/day of prednisone or prednisone equivalent or at a dose that hasn't been stable for at least 4 weeks prior to baseline;
* Any therapy by intra-articular injections (e.g. corticosteroid, hyaluronate) within 4 weeks prior to screening;
* Use of more than 1 NSAID or COX-2 inhibitor.
* Contraindication to MRI.
* History of known or suspected complete ankylosis of the spine.
* Presence of very poor functional status or unable to perform self-care.
* Have undergone surgical treatment for ankylosing spondylitis within the last 12 weeks prior to screening.
* Administration of a live or attenuated vaccine within 12 weeks prior to baseline.
A Study to Evaluate ATP150/ATP152, VSV-GP154 and Ezabenlimab in Patients With KRAS G12D/G12V Mutated PDAC (KISIMA-02)

The goal of this clinical trial is to test an experimental treatment (immunotherapy) in pancreatic cancer patients. The main research objectives are:

* to evaluate if the KISIMA-02 treatment is safe and well-tolerated (first part)
* to evaluate if the KISIMA-02 treatment has an impact on the time to observe a possible reappearance of the tumor (second part)

Participants will receive:

i) a therapeutic protein vaccine ATP150 or ATP 152 ii) a viral vector VSV-GP154 iii) an immune checkpoint inhibitor Ezabenlimab In the second part of the study, researchers will compare treatment group versus observational group.

This is an open-label, phase 1b study to evaluate the safety, tolerability, immunogenicity and preliminary efficacy of a heterologous prime-boost vaccine (protein and viral vector) regimen without/with the PD-1 inhibitor Ezabenlimab.

COMPLETED - Part A (metastatic and locally advanced PDAC patients) Cohort A: ATP150/ATP152 and VSV-GP154 treatment

ONGOING - Part B (locally advanced and resected PDAC patients) Cohort B: ATP150/ATP152, Ezabenlimab and VSV-GP154 treatment Cohort B1, B2, B3: dose escalation

NOT STARTED YET - Part C (resected PDAC patients) Cohort C: ATP150/ATP152, Ezabenlimab and VSV-GP154 treatment (treatment versus observational arm)

Eligibility Criteria:
Key inclusion criteria

* Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC) with KRAS G12D or KRAS G12V mutation.
* ECOG performance status of 0 or 1.
* Patients with advanced or metastatic disease who completed at least 16 weeks of standard systemic chem-/chemoradiotherapy and achieved a partial response or stable disease.
* Patients who underwent confirmed R0 or R1 resection and completed at least 3 months of combined peri-adjuvant multiagent chemotherapy.
* No evidence of disease progression or recurrence.
* Start of study treatment within 12 weeks from the last curative treatment (resected PDAC).
* Life expectancy at least 12 months (resected PDAC), or at least 6 months (advanced/metastatic PDAC).
* Archival tumor tissue availability for central KRAS analysis.

Key exclusion criteria

* Not yet recovered from surgery (resected PDAC).
* Gastro-intestinal bowel obstruction.
* Other malignancy within the last 3 years.
* Prior chemotherapy or targeted small molecule therapy within 14 (locally advanced/metastatic PDAC) or 28 (resected PDAC) days from initiation of study treatment.
* Prior radiotherapy within 14 (advanced/metastatic PDAC) or 28 (resected PDAC) days from initiation of study treatment.
* Prior use of immunotherapeutic agents, including but not limited to checkpoint inhibitors or VSV-based agents.
* Diagnosis of immunodeficiency.
* Chronic systemic treatment with steroids or other immunosuppressive medications.
* Active autoimmune disease requiring systemic treatment within the last 2 years.
* Use of Tamoxifen within 1 month prior to start of study treatment
Characterization of Adipose Derived Regenerative Cells (ADRCs) From Patients With Chronic Heart Disease

Human adipose tissue is now recognized as an acceptable, highly abundant source of adipose-derived regenerative cells (ADRCs). ADRCs are a heterogeneous or mixed population of cells found in adipose tissue including adult stem cells, leukocytes, connective tissue and vessel-associated cells. Autologous adult regenerative cells are thought to promote healing of scarred or injured tissue. While the investigators are learning more about the exact mechanisms every day, it is believed that this heterogeneous population of cells influences the local environment via cell-to-cell signaling, immune modulation, and differentiation into other cell types. The use of ADRCs in the treatment of many different medical conditions (including cardiovascular disease, soft tissue defects, wound healing, and many more) is being evaluated in numerous clinical and preclinical studies around the world. While there is a considerable amount of information regarding the cellular composition of ADRCs isolated from healthy donors, basically there is no much data regarding the ADRC composition from cardiac patients. In this study, adipose tissue or cells from chronic heart ischemia patients, that would otherwise be thrown away in waste, will be provided to researchers who will study these cells with the objective to characterize ADRCs derived from patients with a heart disease and to compare if a heart disease state does impact ADRC cell composition.


Eligibility Criteria:
Inclusion Criteria:

* Patients enrolled in the ATHENA clinical trial that donated their leftover material to be studied.

Exclusion Criteria:

-
Phosphodiesterase Type 5 Inhibitors in Patients With Group 2 Pulmonary Hypertension

The goal of this clinical trial is to test the efficacy of tadalafil in patients with group II pulmonary hypertension with elevated pulmonary vascular resistance (PVR). The main question it aims to answer is:

• Can tadalafil improve patients with group II pulmonary hypertension with elevated PVR? Participants will undergo right heart catheterization (RHC) to make sure they are fulfilling the inclusion criteria, then will be asked to take tadalafil 20 mg for two weeks then 40 mg if tolerated for 12 weeks, then participants will be followed up. Investigators will compare the drug group with another age- and sex- matched control placebo group.

The study aims at studying the efficacy of tadalafil in patients with group 2 pulmonary hypertension with elevated pulmonary vascular resistance guided by RHC. After fulfilling the inclusion criteria, investigators will recruit 48 patients, and do baseline echocardiography for comprehensive right ventricular (RV) study and 6 minute walk test, and then start tadalafil 20 mg then 4mg if tolerated, for 24 patients (drug group). After three months follow up, investigators will follow up the patients regarding RV function and the functional capacity, compared to matched control group.

Eligibility Criteria:
Inclusion Criteria:

* group 2 pulmonary hypertension with precapillary component with PVR more than 4 by RHC
* Patients should be on HF medical therapy 90 days before enrollment in the study.

Exclusion Criteria:

* Anticipated cardiac resynchronization therapy within 3 months of enrollment.
* Hypersensitivity, allergy, or intolerable side effects of PDE-5 inhibitors.
* Contraindication to PDE-5 inhibitors, including current nitrate therapy.
* All groups of PH, other than group 2 PH (isolated post capillary pulmonary hypertension).
* History of heart transplant, ventricular-assist device, or any other solid-organ transplant
* Likely to have solid-organ transplant or any other major surgery during study enrollment/treatment period.
* Female subject who is pregnant, breast-feeding, or unwilling to practice an acceptable method of birth control unless postmenopausal or sterile.
* Unreliability as a study participant, based on the investigator's (or designee's) knowledge of the subject (e.g., alcohol or other substance abuse, inability or unwillingness to adhere to the protocol, documented noncompliance, or vulnerable population)
* Current enrollment, or enrollment completed \<30 days previously, in another investigational drug or device clinical study.
* Undergoing dialysis for end-stage renal disease.
* End-stage liver disease comorbidities, limiting exercise tolerance.
* Morbid obesity (body mass index \> 40).
* Severe peripheral vascular disease with intermittent claudication.
* Status after amputation of lower extremity(s) at any level.
* Severe degenerative joint disease preventing normal walking.
* Cerebrovascular accident with long-term sequelae affecting ability to walk.
A Study of EXP039 Treatment in Subjects With r/r NHL Subjects

This is a single-center, non-randomized study to evaluate the safety and efficacy of EXP039 in relapsed and/or refractory NHL patients.

The study will include the following sequential phases: Screening, Apheresis, Baseline, Pre-Treatment (Cell Product Preparation, Lymphodepleting Chemotherapy), EXP039 infusion and Follow-up Visit.

Eligibility Criteria:
Inclusion Criteria:

1. The patient volunteered to participate in the study and signed the Informed Consent
2. Age ≥18 years old ≤70 Years old, male or female
3. Expected survival ≥ 12 weeks
4. ECOG score 0-2
5. CD19 or CD20 positive B-NHL confirmed by cytology or histology according to WHO2016 criteria
6. Patients with a clear diagnosis of relapsed and/or refractory B-NHL, including DLBCL, FL and MCL
7. For CD20-positive subjects, they should have received at least one regimen containing anti-CD20-targeted therapy (such as rituximab). If they do not complete the regimen due to intolerance, the cause of intolerance should be recorded
8. No contraindications of apheresis
9. At least one measurable lesion according to Lugano 2014 criteria
10. Adequate organ function and adequate bone marrow reserve

Exclusion Criteria:

1. Malignant tumors other than B-NHL within 5 years prior to screening, except cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery
2. Active HIV, HBV, HCV or treponema pallidum infection
3. Any instability of systemic disease, including but not limited to active infection (except local infection), severe cardiac, liver, kidney, or metabolic disease need therapy
4. Female subjects who have been pregnant or breastfeeding, or who plan to conceive during or within 1 year after treatment, or male subjects' partner plans to conceive within 1 year after their cell transfusion
5. Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment
6. Patients who have been previously infected with tuberculosis
7. Administered Corticosteroids and/or other immunosuppressants within 7 days before apheresis. and 5 days before the infusion of EXP039
8. Patients with central nervous system involvement
9. Any systemic antitumor therapy performed within 2 weeks before enrollment
10. Previous use of any CAR T cell product or other genetically modified T cell therapy
Trial of Preoperative Hepatic and Regional Arterial Chemotherapy (PHRAC) to Prevent Postoperative Liver Metastasis of Colorectal Cancer

The purpose of this study is to investigate whether preoperative hepatic and regional arterial chemotherapy are able to prevent liver metastasis and improve overall survival in patients receiving curative colorectal cancer resection.

We administered FUDR, MMC and Oxaliplatin as preoperative hepatic and regional arterial chemotherapy (PHRAC) to patients with Stage II or Stage III colorectal cancer without apparent liver metastasis based on a thorough preoperative evaluation. The study endpoints were disease-free survival, overall survival, and liver metastasis-free survival as evaluated by intent-to-treat analysis.

Eligibility Criteria:
Inclusion Criteria:

* age \< 75 years with histologically proven adenocarcinoma of the colon or rectum
* no severe major organ dysfunction
* WHO performance status of 0 or 1
* no prior cancer therapy
* Stage II (T3-4, N0, M0) or Stage III (T0-4, N1-2, M0) disease (according to the 1997 revision of the International Union Against Cancer TNM staging system) as determined by a preoperative evaluation that included colonoscopy and an abdominal computed tomography (CT) scan

Exclusion Criteria:

* age \>= 75
* severe major organ dysfunction
* WHO performance status of \>1
* prior cancer therapy
* Stage I or Stage IV
Paediatric Safety Study in Cat-PAD

Study to Assess the Safety of Cat-PAD in Cat Allergic Paediatric Subjects


Eligibility Criteria:
* Inclusion Criteria

  * Male or female, aged 5-12 years.
  * Moderate to severe rhinoconjunctivitis on exposure to cats for at least 2 years.
  * Subjects may optionally also have GINA Step 1 controlled asthma.
  * Positive skin prick test to cat hair.
  * Cat dander specific IgE ≥0.35 kU/L.
* Exclusion Criteria

  * Asthma falling under the GINA definitions "partly controlled" and "uncontrolled" or Steps 2 to 5.
  * FEV1 \<80% of predicted.
  * Clinically relevant abnormalities detected on physical examination.
  * History of severe drug allergy, severe angioedema or anaphylactic reaction to food.
Heart TIMING - Heart Transplantation IMagING

The cardiac allograft rejection (CAR) and cardiac allograft vasculopathy (CAV) significantly affect the prognosis of patients after heart transplantation. The aim of the present study is to investigate and differentiate the adaptive and pathological cardiovascular changes after heart transplantation using different modalities. The investigator's main purpose is to define the role of the cardiovascular imaging methods and biomarkers in the early diagnosis of CAR and CAV.

1. 12-lead ECG - Resting standard 12-lead digital ECG will be recorded. Extended analysis will be performed according to the latest recommendations.
2. Holter ECG - 24 hour Holter ECG will be recorded. Extended Holter ECG analysis will be performed.
3. Life quality questionnaire, patient history - Detailed questionnaire about personal and family history, general symptoms and life quality.
4. Laboratory biochemical examination - Besides the regular routine laboratory parameters, several specific parameters are planned to be measured, such as cardiac biomarkers.
5. Endomyocardial biopsy
6. Detailed transthoracic echocardiography including strain analysis and 3D measurement
7. Detailed cardiac magnetic resonance (CMR) examination
8. Coronary imaging - invasive coronarography and intravascular ultrasound (IVUS) and/or optical coherence tomography (OCT)
9. Invasive pressure measurement - Measurement of coronary flow reserve (CFR) and microcirculation resistance index (IMR)

Eligibility Criteria:
Inclusion Criteria:

* First heart transplantation

Exclusion Criteria:

* Cardiogenic shock on/after day 28 after heart transplantation
* Lack of consent
* Lack of cooperation
Adipose Tissue in Crohn´s Disease Fistulas

Present study investigated the efficacy of injection of freshly collected autologous adipose tissue into perianal fistulas in patients with Crohn's disease. Adipose tissue collected by liposuction was injected into the perianal fistulas. Primary objective was complete clinical healing six months after treatment. Secondary objectives were reduced or ceased fistula secretion and complications to the treatment.

Investigators prospectively registered symptoms, complications and results of treatment in 21 patients with Crohn´s Disease who underwent treatment with freshly harvested autologous adipose tissue for perianal fistulas between March 2015 and June 2018. Inclusion criteria consisted of the following: the presence of complex CD fistulas refractory to standard surgical intervention, including long-term seton and regular curettage, and/or medical treatment. Pelvic magnetic resonance imaging (MRI) was performed to describe the location and extent of the fistula. Clinical examinations of the patients were performed at intervals of six weeks, three months and six months following adipose tissue injection. Primary endpoint was complete fistula healing at clinical examination six months after the last injection. A fistula was considered completely clinically healed: (i) if the patient had no symptoms of discharge; (ii) if there was no visible external fistula opening in the perineum; and (iii) if no internal opening could be palpated with rectal digital examination. Secondary endpoints included either reduced or ceased fistula secretion. If clinical healing of the fistula was not obtained six weeks after the first treatment, patients were offered a second adipose injection within two weeks. A third injection was offered to patients who did not have complete healing within six weeks of the first two injections.Pelvic MRI was repeated in all patients with transsphincteric and intersphincteric fistulas who, upon clinical examination, demonstrated complete healing at 6 months after the last injection.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Crohn´s Disease
* presence of complex Crohn´s Disease fistulas
* fistulas refractory to standard surgical intervention, including long-term seton and regular curettage, and/or medical treatment.

Exclusion Criteria:

- Fistulas developed following proctectomy were excluded.