cyrilzakka/clinical-trials huggingface dataset:
Panitumumab Regimen Evaluation in Colorectal Cancer to Estimate Primary Response to Treatment

The primary objective is to estimate the effect of the human homolog of the Kirsten rat sarcoma-2 virus oncogene (KRAS) mutation status (wild type versus mutant) from tumor tissue on efficacy endpoints in patients with metastatic colorectal cancer (mCRC) receiving second-line chemotherapy with panitumumab after failing first-line treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of metastatic adenocarcinoma of the colon or rectum
* Available paraffin-embedded tumor tissue
* Failure of first line treatment containing fluoropyrimidine and oxaliplatin based chemotherapy with bevacizumab for mCRC
* Measurable disease
* Adequate hematologic, renal, hepatic and metabolic function

Exclusion Criteria:

* Radiotherapy ≤ 2 weeks prior to Day 1 of Cycle 1
* Unresolved toxicity(ies) from prior anti cancer therapy that, in the opinion of the investigator, precludes the subject from study enrollment
* Prior irinotecan therapy, anti epidermal growth factor receptor (EGFr) therapy, or vaccine for the treatment of mCRC
* CYP3A4 enzyme inducers, inhibitors, and substrates (eg, phenytoin, phenobarbital, carbamazepine, ketoconazole, rifampin, rifabutin, and St. John's Wort) ≤ 2 weeks prior to Day 1 of Cycle 1
* Infection requiring systemic anti infectives completed ≤ 2 weeks prior to Day 1 of Cycle 1
* Clinically significant cardiovascular disease
* History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis)
* Pulmonary embolism, deep vein thrombosis, or other significant thromboembolic event ≤ 8 weeks prior to Day 1 of Cycle 1
* Any significant bleeding ≤ 6 weeks prior to Day 1 of Cycle 1, per the investigator's judgement
* Gastroduodenal ulcer(s) determined by endoscopy to be active or uncontrolled gastrointestinal ulcer ≤ 4 weeks prior to Day1 of Cycle 1
* Any co-morbid disease or condition that could increase the risk of toxicity (eg, dihydropyrimidine deficiency, significant ascites, or pleural effusion)
* Major surgery (requiring general anesthesia), open biopsy, or significant traumatic injury ≤ 4 weeks prior to Day1 of Cycle 1. Subjects must have recovered from surgery and have no significant complications
Hemodiafiltration With Endogenous Reinfusion on Uremic Toxins Clearance of Maintenance Hemodialysis Patients

1.1Primary Objective To evaluate the clearance rate of uremic toxin β2-microglobulin (β2-MG), indoxyl sulfate and λ-free light chain (λFLC) by HFR.

1.2Secondary Objectives 1.1.1 To evaluate the clearance of low molecular weight uremic toxin urea (spKt/V, URR).

1.1.2 To evaluate the clearance of other middle molecules and macromolecular uremic toxins, including α1-microglobulin (α1-MG), κ-free light chain (κFLC), homocysteine (Hcy), interleukin-6 (IL-6), p-cresol, YKL-40, complement factor D (CFD), leptin, hippuric acid, trimethylamine oxide (TMAO), asymmetric dimethylarginine (ADMA), tumor necrosis factor-α (TNF- α), myoglobin, fibroblast growth factor 23 (FGF23) and intact parathyroid hormone (iPTH).

1.1.3 To evaluate the clearance of serum albumin, branched chain amino acids and vitamins A, C, E.

1.1.4 To evaluate the comfort of HFR treatment for MHD patients.


Eligibility Criteria:
Inclusion Criteria:

* 18-75 years old, regardless of gender.
* MHD for at least 3 months, and blood purification treatment for 3 times per week.
* The vascular access is autogenous arteriovenous fistula or artificial blood vessels，with a blood flow ≥200mL/min.
* spKt/V≥1.2.
* Patients who signed the informed consent form (ICF) voluntarily.

Exclusion Criteria:

* Patients who have participated in other interventional clinical trials within a month.
* Pregnant or lactating women.
* Patients of NYHA class IV or occurred acute coronary syndrome or myocardial infarction in 3 months before the start of the study.
* Patients with active hemorrhage in 2 weeks (e.g., cerebral hemorrhage, gastrointestinal hemorrhage, fundus hemorrhage, etc.).
* Patients with unstable blood pressure (pre-dialysis systolic blood pressure ≥180 or ≤90mmHg, pre-dialysis diastolic blood pressure ≥100 or ≤60mmHg), severe anemia (hemoglobin ≤60g/L), and high risk of blood coagulation (e.g., albumin ≤25g/L or hemoglobin ≥140g/L).
* Patients with severe infection (the level of hypersensitive C-reactive protein(hsCRP) ≥ 10×upper limit of normal).
* Patients with a history of drug addiction or severe mental disorders.
* Other conditions in which the investigators reject patients to participate in this study.
Nexavar as First Targeted Therapy in Patients With Advanced Renal Cell Carcinoma

This is an observational study which will investigate the use of Nexavar as first targeted therapy in patients with advanced renal cell carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of advanced Renal cell carcinoma (RCC) for whom the decision has been taken by the investigator to prescribe Nexavar.
* Patients who failed cytokine therapy or who are not suitable for cytokines for whom Nexavar is the first targeted drug treatment.

Exclusion Criteria:

* Prior targeted therapy for RCC
* Contraindications of Nexavar described in the Summary of Product Characteristics (SPC).
Effectiveness of Play-Based Training on Executive Functioning in Pre-School Children

The aim of this study is to examine the effectiveness of a play-based intervention designed to support the development of executive functioning in 3-5-year-old children. The intervention is implemented in the day care setting as a part of early childhood education in collaboration with parents and local healthcare and social welfare workers. The study hypothesizes that the intervention as an add-on to normal early childhood education brings added benefits to the development of children's executive functioning in comparison to early childhood education without the add-on.

This cluster-randomized controlled trial examines the effectiveness of a play-based intervention, added as a component to normal early childhood education, in supporting the development of executive functioning in 3-5-year-old children in comparison to early childhood education without such a component. 12 day care centers in Finland have been randomized to intervention (n = 6) and control (n = 6) groups. The children in the intervention group will receive the intervention in the spring of 2021, and the children in the control group will be on the wait list and receive the intervention in the fall of 2021 after measurements. In the day care centers belonging to the intervention group, play sessions supporting the development of children's executive functioning will be arranged as a part of normal early childhood education. The pre-selected games target children's executive functions and self-regulatory abilities, e.g. inhibition, attention, working memory and emotion regulation. The first phase of the intervention (6 weeks) includes play sessions for all children as well as a parents' evening. In the second phase (8 weeks), more individualized play sessions are arranged for the children that exhibit difficulties in executive functions after the first phase. Also, a parents' group is arranged in this phase, which will expand the daily play activities to homes. Day care education personnel and parents fill out questionnaires concerning children's behavior at 4 time points, and the children participating in the second phase (small group activity) will complete two iPad tasks before and after the small group activity. The study takes place in Finland.

Eligibility Criteria:
Inclusion Criteria:

* Children born between 4.6.2015 - 11.1.2018
* For the second phase (small group activity): children must exhibit problems in executive functions (e.g. inattention, hyperactivity, impulsivity) and be considered as potentially benefitting from additional practice as assessed by early childhood educators

Exclusion Criteria:

-
Evaluation of Atuna Racemosa Toxicity

For thousands of years people in the South Pacific have used Atuna racemosa extract as a topical anti-inflammatory. We, the researchers at the Mayo Clinic, have shown this extract to also have antibacterial properties. While this extract has been used for decades in the South Pacific, a controlled clinical trial to evaluate toxicity has never been performed.


Eligibility Criteria:
The subjects will be 20 healthy male and non-pregnant, non-lactating, female volunteers of ages 18 - 65. No subject will be excluded based on minority status.
Improving Neuroprotective Strategy for Ischemic Stroke With Sufficient Recanalization After Thrombectomy by Intra-arterial Cocktail Therapy (INSIST-CT)

Thrombolysis and endovascular thrombectomy are the most efficient treatments for acute ischemic stroke patients in time window. Although sufficient recanalization after thrombectomy is more than 80%, HERMES study indicated that nearly half of the ischemic stroke patients under thrombectomy suffered obvious disability. Artery reocclusion, hemorrhagic transformation, and no-reflow phenomenon are among the most important reasons of poor prognosis of acute ischemic stroke patients. The investigators speculate that a combination of argatroban, edaravone, and glucocorticoid may be helpful in preventing artery reocclusion, hemorrhagic transformation, and no-reflow phenomenon. This study intends to explore the safety, feasibility and efficacy of thrombectomy with sufficient recanalization bridged by intra-arterial cocktail therapy in acute ischemic stroke patients.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years.
2. Patients who presented with acute ischemic stroke and a large vessel occlusion in the anterior circulation and met the criteria of mechanical thrombectomy.
3. Sufficient recanalization （TICI 2b-3）within 7 hours of stroke onset.
4. The availability of informed consent.

Exclusion Criteria:

1. insufficient recanalization（TICI \< 2a）after endovascular treatment;
2. Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage.

4. Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia （ \<100000/mm3）.

5. Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis.

6. Severe uncontrolled hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg).

7. Patients with contraindication or allergic to any ingredient of drugs in our study.

8. Unsuitable for this clinical studies assessed by researcher.
Piezosurgical vs Conventional Exodontia Surgery in Healthy and Patients With Diabetes Mellitus Type 2

This study will evaluateand compare intraoperative and postoperative clinical parameters related to discomfort and wound heeling, as well as laboratory wound healing parameters after piezosurgical and conventional surgery approach during complex exodontia in healthy and patients with Diabetes Mellitus Type 2


Eligibility Criteria:
Inclusion Criteria:

* multiple multi-rooted teeth indicated for extraction
* controlled DMT2

Exclusion Criteria:

* HbA1c \>7%
* chronic orofacial pain and infection in orofacial region
* alcohol and tobacco consumption
* pregnant women and nursing mothers
Interferon-alpha As Maintenance Therapy for Favorable-risk Acute Myeloid Leukemia

This research focuses on a prospective, randomized, controlled trial of "Interferon-alpha as maintenance therapy for favorable-risk acute myeloid leukemia." By fully utilizing prospective, randomized, controlled clinical trial and studying the negative conversion of MRD and the survival of favorable-risk AML patients, it aims to explore the efficacy and safety of Interferon-alpha in the maintenance treatment of favorable-risk AML and identify effective measures to prevent relapse, thereby improving the survival of favorable-risk AML patients. The primary endpoint is the negative conversion of MRD at 6 months. The secondary endpoints include the 2-year cumulative incidence of relapse, 2-year event-free survival (EFS), 2-year overall survival (OS), and safety.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-70 years old (including 18 and 70 years old) with newly diagnosed favorable-risk AML (2022 ELN risk group classification).
* Achieved CR1 after 1-2 cycles of standard chemotherapy.
* Completed 4-6 cycles of consolidation chemotherapy (including at least 2 cycles of high-dose Cytarabine HDAC regimem).
* At the end of consolidation treatment, bone marrow examination confirmed in CR1, flow cytometry MRD negative, but molecular MRD genes (RUNX1:: RUNX1T1, NPM1, and CBFb:: MYH11) decreased by \> 3 log, but still detectable.
* Performance status score of 0-2 (ECOG).
* Liver function: ALT and AST ≤ 2.5 times the upper limit of normal, bilirubin ≤ 2 times the upper limit of normal.
* Kidney function: Creatinine ≤ 1.5 times the upper limit of normal.

Exclusion Criteria:

* Acute promyelocytic leukemia (APL).
* AML with normal karyotype and bZIP intramolecular mutations in CEBPA.
* ≥ CR2 status.
* Patients strongly demanding transplantation, and with indications for transplantation but not eligible for transplantation.
* Uncontrolled active infection.
* Severe organ dysfunction.
* Pregnancy.
* Unwillingness to undergo interferon treatment.
* Previous hyperthyroidism or hypothyroidism.
* Participation in other clinical trials within one month.
Microbiome Analysis of Skin and Airway Samples and Effect of Face Masks

The goal of this study is to optimize two methods for microbiome analysis of skin and upper airway samples (16S amplicon sequencing and Shotgun sequencing). In addition, the researchers will investigate whether there is an effect of wearing a face mask on the microbial communities of the skin and upper airways. The volunteers will self-collect swabs of the skin and upper airways (nose and/or throat). Bacterial DNA and/or total RNA will be isolated and the microbial communities will be investigated with 16S amplicon sequencing and shotgun metagenomic sequencing.


Eligibility Criteria:
Inclusion Criteria:

* Adult age 18 at the start of the study

Exclusion Criteria:

* Pregnant women
Familial Partial Lipodystrophy Study

Studying patients with rare adipose tissue disorders may help the investigators to better understand the pathophysiology of diabetes and dyslipidemia in relation to adiposity, and thus have an enormous impact on public health.

A systematic study of body fat distribution is necessary to better define the phenotypic spectrum of FPL, and to better recognize FPL in patients with Metabolic Syndrome. Similarly, genetic studies in these patients will not only help better characterize the genotype-phenotype relationship, but is also likely to help identify other genes involved in regulation of lipid homeostasis, as some patients may not have any of the known mutations.

The Investigators will systematically study mitochondrial protein quality and function under fasting and fed state in relation to intramyocellular and circulating plasma lipid levels, and compare with age, sex and BMI-matched individuals. The Investigators will also study the rate of de-novo protein synthesis to determine if hyperinsulinemia affects both muscle protein anabolism and catabolism.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of lipodystrophy (decreased subcutaneous fat)
2. Family history of lipodystrophy
3. Normal control subject

Exclusion Criteria:

1. Inability to provide informed consent
2. Hemoglobin \< 10g%
Efficacy and Tolerance of JAK Inhibitors in ATU for Atopic Dermatitis

The aim is to assess effectiveness (EASI, SCORAD, IGA, DLQI, pruritus, sleep loss) and safety (clinical and biological adverse events) of JAK inhibitors in adults with moderate-to-severe atopic dermatitis in a real-life French multicenter retrospective cohort


Eligibility Criteria:
Inclusion Criteria:

* Adults
* moderate to severe atopic dermatitis
* treated by JAK inhibitors between december 2020 and september 2021
* inefficiency, loss of efficiency or contra-indication of previous systemic agent, DUPILUMAB or phototherapy
* ineligibility to French ongoing clinical trials

Exclusion Criteria:

* Children
* mild atopic dermatitis
* eligibility to CICLOSPORINE, METHOTREXATE, DUPILUMAB, phototherapy
* eligibility to French ongoing clinical trials
* patients' opposition for the use of their records
* follow up \<3 months
IDENTIFICATION OF SENTINEL NODE(S) IN BREAST CANCER

The study is based on the identification of sentinel node(s) by SENTIMAG / SIENNA + in addition to the usual method (blue and /or radioactive product). This is a feasibility study

* Identification of Sentinel node(s)

  1. Step 1: Identification using the technique Nanocis Sub-areolar injection of Tc99m-Nanocis ® the day before or the day of surgery
  2. Step 2: Identification using the technique SentiMag ® / Sienna+ Injection Sienna + ™ should be done just after induction of anesthesia and before the injection of Patent Blue dye
  3. Step 3: Identification using the technique of Patent Blue Dye or Lymphotropic dye injection or Patent Blue is performed after induction of anesthesia, the injection and production Sienna + ™, the operating theater by the surgeon
* Detection of Sentinel node(s)

  1. Step 1: probe SentiMag ® (study)
  2. Step 2: hand probe gamma radiation detection and / or colorimetric detection (standard)
* Sentinel node's excision of radioactive and / or blue and / or magnetic (colored brown-brown)
* After the procedure:

Characterization of the size and weight of lymph nodes, histological and / or molecular OSNA and linking nodal status with the detection rate of sentinel nodes for each technique.

NB: In case of synchronous bilateral cancer, 2 records are possible

Eligibility Criteria:
Inclusion Criteria:

* Patient with invasive breast cancer or microinfiltrant proven by cytology and histo-or whatever the histological type
* cT0/cT1/cT2 (up to 5 cm) CN0 clinical and / or ultrasound and without prior treatment (chemotherapy or neoadjuvant hormone )
* Age greater than or equal to 18
* Reporting of breast surgery and axillary staging of sentinel lymph node
* Using effective contraception (BHCG negative)
* Patient affiliated with a health insurance
* Consent signed by the patient

Exclusion Criteria:

* T3 or T4 tumors (\> 5 cm, cutaneous or muscle inflammation or cancer)
* Presence of a clinically suspicious axillary adenopathy or imaging
* Tumors bifocal or multifocal known before Surgery
* History of breast surgery or axillary
* Patient metastatic
* Patient with a cons-indication anesthesia and / or surgery
* Intolerance or hypersensitivity to the compounds or iron dextran or superparamagnetic iron oxide or to Patent blue dye in centers where it is commonly used
* Patient can not receive a radioactive isotope to the sentinel lymph node resection
* Allergy radioactive product
* Chronic iron overload
* Pacemaker or other implantable device in the chest wall
* Failure to submit to medical study for geographical, social or psychological
* Patient deprived of liberty or under guardianship
* Pregnant or lactating
Ezetimibe and Atorvastatin vs. Atorvastatin in Patients Age 65 and Older at High Risk for Coronary Heart Disease (CHD)(0653-112)

A 12 week clinical trial in patients 65 years of age and older with hypercholesterolemia at high risk for coronary heart disease to study the effects of atorvastatin and ezetimibe given in combination and two higher doses of atorvastatin on lipid lowering.


Eligibility Criteria:
Inclusion Criteria:

* Patient is age 65 or older
* Patient is willing to maintain cholesterol lowering diet
* Patient has hyperlipidemia with LDL level greater than 70 mg/dl or 100 mg/dl depending on their CHD risk category

Exclusion Criteria:

* A condition which, in the opinion of the investigator, would pose a risk to the patient or interfere with participation in the study
* Patient is unlikely to be compliant in taking study medication
* Patient with chronic or unstable medical condition
* Patient is taking unstable doses of medication
* Patient drinks more than 2 alcoholic drinks per day
* Patient has elevations in certain laboratory values (CK, AST, ALT)
Knee Osteoarthritis and Kinesiophobia

Kinesiophobia after total knee arthroplasty is an important parameter affecting recovery. However, the relationship between kinesiophobia and the factors it may cause is not clear. Therefore, this study aimed to examine the relationship between kinesiophobia, pain, fear of falling, mobility and proprioception in the early period after total knee arthroplasty.

Various biopsychosocial factors affect the recovery process and quality of life after total knee arthroplasty. This situation reaches a level that can affect the daily life activities of patients, especially in the long term. Especially kinesiophobia is one of these factors. This condition also affects the proprioceptive sense in the knee, the capacity to move and the fear of falling. However, studies have generally examined long-term effects after total knee arthroplasty. Early studies are limited in number. More studies are needed to better understand the relationship between kinesiophobia and biopsychosocial factors. Additionally, the lack of relationship between the patients' kinesiophobia level, fear of falling, and proprioception in the early period after TKA draws attention. Therefore, this study aimed to examine the relationship between kinesiophobia, pain, fear of falling, mobility and proprioception in the early period after TKA.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-80
* Total knee arthroplasty surgery due to knee osteoarthritis
* Volunteering to participate in the study

Exclusion Criteria:

* Previously had knee surgery or fracture
* Diagnosed with rheumatoid arthritis
* Those with severe obesity (BMI \> 40 kg/m2)
* Those with sensory and motor impairments
* Revision knee arthroplasty planned
* Venous thromboembolism
* Neurological diseases (MS, Parkinson, etc.)
* Early post-surgical complications
Evaluating the Efficacy of Ragweed-SPIRE Following Exposure to Ragweed Allergen in an Environmental Exposure Chamber

The purpose of this study is to determine whether Ragweed-SPIRE is safe and effective at reducing allergy symptoms in people who suffer from allergy to Ragweed pollen


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18-65 years.
* Reliable history consistent with moderate to severe rhinoconjunctivitis on exposure to ragweed for at least the previous two seasons.
* Minimum qualifying rhinoconjunctivitis symptom scores
* Ragweed-specific Immunoglobulin E (IgE) \> 0.70 kU/L.

Exclusion Criteria:

* Subjects with a history of ragweed pollen induced asthma
* A history of anaphylaxis to ragweed allergen.
* FEV1 \< 80 % of predicted.
* Subjects who cannot tolerate Baseline Challenge in the EEC.
* Subjects for whom administration of epinephrine is contraindicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).
* History of immunopathological diseases (e.g. multiple sclerosis) that in the opinion of the Investigator or the Sponsor could interfere with the results obtained from the study.
* A history of severe drug allergy, severe angioedema or anaphylactic reaction to food.
* A history of any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment)