cyrilzakka/clinical-trials huggingface dataset:
Comparative Study (Double-Blind) of MRA for Rheumatoid Arthritis (RA)

The purpose of this study is to investigate the clinical efficacy and safety of MRA in a double-blind, parallel-group, controlled study using MRA or methotrexate (MTX) in rheumatoid arthritis (RA) patients with MTX administered.


Eligibility Criteria:
Inclusion criteria

* Diagnosis of RA based on the 1987 classification criteria of the American College of Rheumatology (ACR)
* Disease duration of 6 months or more
* Treated with 8 mg/week of MTX for at least 8 weeks immediately preceding enrollment, and continued on this treatment up to initiation of the study drug
* Active disease at enrollment (less than 2 weeks before initiating treatment with a study drug), Which is defined as having at least 6 tender and 6 swollen joints among 49 and 46 joints stipulated by the Japanese Rheumatism Foundation's Drug Evaluation Committee and ESR at least 30 mm/hr and CRP not less than 1.0 mg/dL

Exclusion criteria

* Assessed as having Class IV Steinbrocker functional activity in the 4 weeks preceding treatment with the study drug
* Treated with infliximab, etanercept or leflunomide in the 12 weeks preceding treatment with the study drug
* Received any of the following therapies in the 2 weeks preceding initiation of treatment with the study drug.

  1. Administration of any DMARD or immunosuppressant other than MTX
  2. Administration of corticosteroids exceeding 10 mg/day as prednisolone
  3. Dose escalation or initiation of corticosteroids
* Received any of the following therapies in the 4 weeks preceding treatment with the study drug

  1. Plasma exchange therapy
  2. Surgical treatment (operation, etc.)
Persistent Postpartum Hypertension Pilot Trial

This study is a pilot, open-label, randomized controlled trial of postpartum women with hypertensive disorders pregnancy and persistent non-severe blood pressure. The purpose of the study to provide data that may provide guidance regarding blood pressure management of patients with non-severe postpartum hypertension. There are limited guidelines for best practice with persistent, non-severe hypertension, and treatment in this situation is usually at the provider's discretion.

Study groups will include a treatment with nifedipine extended release or no treatment. Subjects will be randomized 1:1. Subjects randomized to the treatment group will be provided the study drug (nifedipine extended release) at an initial dose of 30mg daily in 1-month supply. The control group will not receive any drug for blood pressure control. the primary outcome is systolic blood pressure at 1 week postpartum.

Subjects in both groups will be scheduled for a 1-week postpartum blood pressure check and routine 4 week postpartum visit. Medication compliance in the treatment group will be assessed via validated questionnaire. The primary outcome of this study is average systolic blood pressure at 1 week postpartum. Patients will be given instructions on blood pressure ranges and specific symptoms when they should contact study staff.

Eligibility Criteria:
Inclusion Criteria:

* Antepartum diagnosis of gestational hypertension
* preeclampsia
* superimposed preeclampsia without antepartum chronic hypertension medication
* Delivery at 23 weeks or greater
* Persistent elevation in BP \>24 hours postpartum (\>140/90 mm Hg) (2 or more BP \>4 hours apart)
* 18 years or older
* English speaking

Exclusion Criteria:

* Need for continuation of antepartum antihypertensive medication
* Contraindication of calcium channel blocker use
* Severe range (160/110 mm Hg) blood pressure requiring treatment \>24 hours after delivery
* Requires a 2nd oral antihypertensive medication for blood pressure control inpatient
* Acute cardiomyopathy or heart failure
* Creatinine ≥1.5
* Blood pressure \<90/60 within 24 hours of discharge
Treatment of Ectopic Calcification / Ossification With Sodium Thiosulfate (CATSSO)

Ectopic calcification and ossification complicate many diseases, which are rare for the most part. These calcifications (or ossifications) are generally classified according to their apparent formation mechanism. Even if very different diseases can be at the origin, these calcifications (or ossifications) have as common points: an unknown physiopathology, a composition of calcium pyrophosphate for the most part and l no curative treatment validated to date.

Indeed, although several reported cases suggest the potential efficacy of different treatments , none of these treatments is currently recognized as effective because of the absence of confirmation data or because of contradictory results.

Sodium thiosulfate (STS) has been used for a long time as an antidote to cyanide poisoning and as a protective agent against cytotoxic side effects such as ifosphamide. More recently, STS has been reported in the treatment of renal calcification. vascular or even subcutaneous. First prospective studies on animal models and in humans seem to confirm the interest of this product in the treatment of these abnormal calcifications.

For several months, a magistral preparation in the form of ointment based on STS has been developed by the pharmacy of Limoges University Hospital in order to combine the local effect of STS while avoiding the side effects of an administration of this treatment by systemic way. The first uses of this preparation appear promising and some preliminary results have already been published. The benefit / risk ratio of this approach seems to be advantageous for clinicians since preparations whose composition is close are currently validated by the FDA and the World Health Organisation for the treatment of benign pathologies such as cutaneous dermatophytes or pityriasis versicolor.


Eligibility Criteria:
Inclusion Criteria:

* any patient treated with sodium thiosulfate dermally provided by the pharmacy of Limoges University Hospital.
* availability of an objective imaging evaluation to compare the volume or surface of calcifications (or ossifications) treated (on two orthogonal incidences) before and after 6 months of treatment application.
* consent to participation in the study signed by the patient or by one of the holders of parental authority in the case of a minor patient.

Exclusion Criteria:

* calcification with concomitant cutaneous rupture which can allow an externalization of the calcium material by mechanical effects.
* Patient with calcification secondary to one of the following pathologies:
* diabetes
* chronic renal failure
* iatrogenic origin
Colonoscopy-related Pain Predicts the Treatment Response of Amitriptyline in Patients With Irritable Bowel Syndrome

Irritable bowel syndrome (IBS) is a functional bowel disorder with recurrent abdominal pain and disordered defecation and is one of the most common gastrointestinal problems. In practice, IBS was frequently diagnosed as an exclusion diagnosis for patients with recurrent abdominal pain without an organic cause. Visceral hypersensitivity is the major contributing factor of abdominal pain in IBS. Accordingly, tricyclic antidepressants (TCAs) are widely used for IBS, especially if abdominal pain is a prominent symptom. Indeed, meta-analysis also exhibits the clinically significant efficacy of low dose TCAs in IBS. Nevertheless, over 40% of IBS patients receiving TCAs had no improvement in symptoms after treatment. Theoretically, if TCAs are used for IBS patients with hypersensitivity, its efficacy could be increased.

Although rectal distension test might be used to identify hypersensitive patients with IBS, it has been used only for clinical research because it is painful for the patient. On the contrary, colonoscopy is frequently performed in IBS patients to rule out organic disease and for the purpose of colorectal cancer screening. In a study by Kim and colleagues, IBS patients reported higher pain score after colonoscopy than non-IBS patients. This has prompted the hypothesis that pain scoring during/after colonoscopy could also segregate IBS patients with visceral hypersensitivity showing better treatment response of TCA than those without.

The aims of the present study were to evaluate the colonoscopy-related pain perception and the treatment response of amitriptyline in IBS patients and to investigate the predictive values of the colonoscopy-related pain scale in identifying IBS patients with a response to amitriptyline treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with IBS according to the Rome III criteria

Exclusion Criteria:

* Inflammatory bowel disease or malignancy on colonoscopy.
* Previous abdominal surgery other than appendectomy or cesarean delivery,
* Major psychiatric disorders or Beck Depression Inventory-II score of ≥19
* Significant cardiopulmonary diseases or any malignancies
* Taking pain modulators including selective serotonin reuptake inhibitors (SSRI) or tricyclic antidepressants
* Polypectomy during colonoscopy.
The Anti-inflammatory Effects of High-fat Nutrition; Towards a Clinical Application

Patients undergoing major surgery, trauma and burns are prone to develop an exacerbated inflammatory response, which is potentially lethal to the individual. Recently our group demonstrated that administration of high fat feeding prior to hemorrhagic shock attenuates severe inflammation, gut barrier loss and hepatic damage. High fat feeding releases cholecystokinin in the gut, which stimulates the autonomous nervous system and subsequently activates the efferent vagus nerve. The activated efferent fibers inhibit tissue macrophages via binding of acetylcholine to the alpha7-nicotinergic receptor.

In this study the cholecystokinin release in healthy volunteers is monitored in response to low fat and high fat food products.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females
* 45 \> age \<55

Exclusion Criteria:

* Gastrointestinal diseases
* Inflammatory conditions
Low-Level Laser Effects on Orthodontic Tooth Movement of Periodontally Compromised Patients.

To investigate the effect of Low Level Laser therapy on orthodontic tooth movement of periodontally compromised patients by evaluating the rate of orthodontic tooth movement and the level of Osteocalcin in the gingival crevicular fluid.

Low-Level laser therapy has been reported as an effective adjunct to non surgical periodontal treatment for inflammation control and tissue reparation in patients with periodontitis. Previous studies have shown that application of low-level laser therapy reduced pocket depth and decreased the inflammatory process through regulatory control of inflammatory cytokines level, therefore this study will investigate the effect of low-level laser on the periodontal tissue .Accelerating orthodontic tooth movement is one of the primary demand in orthodontics to prevent side effects as root resorption, caries and decreased patient compliance . Numerous researchers have also studied the use of LLLT in accelerating orthodontic tooth movement and have considered the laser to be effective while others achieved the opposite . Hence, This study is aiming to investigate the effects of LLLT in accelerating tooth movement.

Eligibility Criteria:
Inclusion Criteria:

* No systemic disease.
* No history medication (antibiotics and/or anti inflammatory) in the previous 4 months.
* Self motivated patients with acceptable oral hygien.

Exclusion Criteria:

* Previous orthodontic treatment
* Aggressive periodontitis
* Smokers
* pregnant patients
Biological Standarization of Cupressus Arizonica Allergen Extract to Determine the Biological Activity in Histamine Equivalent Units (HEP)

Biological Standardization of Cupressus arizonica Allergen Extract.

This is an open, unblinded and non-randomized biological assay. The study design is a slight modification of the recommendations proposed by the Nordic Guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Subject has provided written informed consent, appropriately signed and dated by subject.
* Subject can be male or female of any race and ethinic group.
* Age 18 years and 60 years ata the study inclusión day.
* Positive clinical history of inhalatory allergy to Cupressus arizonica.
* A positive prick test with a standarices commercially Cupressus arizonica allergen extract.
* A positive prick test with positive control of histamine 10 mg/ml.
* A positive test for specific IgE to Cupressus arizonica.

Exclusion Criteria:

* Immunotherapy in the past 5 years with an allergen extract Cupressus arizonca or other allergen extract than may interfere with the allergene to be tested.
* Use of drugs that may interfere before and after with the skin reactions.
* Treatment with certain drugs.
Analysis of Risk Factors Associated With the Development of Toxic Encephalopathy in Acute Diquat Poisoning

This study aims to analyze the risk factors associated with the development of toxic encephalopathy in acute diquat poisoning.


Eligibility Criteria:
Inclusion criteria:

1. history of oral exposure to DQ solution reported by patient or proxy;
2. a specimen for the DQ plasma concentration collected immediately upon admission;
3. documentation that patients or, in case of unconsciousness of the patient, legal proxies were aware of and agreed to treatment plans.

Exclusion critera:

1. they had ingested other toxicants in addition to DQ;
2. DQ was not detected in biological samples;
3. patients with over half of incomplete information;
4. patients with an exposure time (time from exposure to presentation at ED) longer than 48 hours.
Osimertinib for NSCLC With Uncommon EGFR Mutations

This is a multi-center, retrospective study of ucEGFRmut (exon 20 insertions excluded) metastatic NSCLC osimertinib-treated as first EGFR inhibitor. RECIST and RANO-BM brain objective response rate (ORR) were evaluated by investigators. mPFS, mOS and mDOR were calculated from osimertinib initiation. Mutations found at resistance were collected.

The epidermal growth factor receptor ( EGFR) is the most common targetable driver in non-small cell lung cancer (NSCLC). Approximately 90% of the EGFR mutations include an exon 19 deletion and a L858R point mutation at exon 21. Less common mutations include, among others, G719X in exon 18, L861Q in exon 21, exon 20 insertions, S768I in exon 20, and T790M in exon 20. Osimertinib is an EGFR TKI that has been developed as non-competitive inhibitor targeting a range of EGFR mutant molecules, currently regarded as the first-line treatment of choice to EGFR mutant (EGFRm) patients. Inhibition of the less common EGFR mutant by osimertinib has been demonstrated.

Real-world data showed lower response rate (RR) and progression free survival (PFS) in patients harboring uncommon EGFR mutations compared to the ones with common mutations treated with EGFR TKIs. Osimertinib as treatment for patients with rare mutations has been assessed in a single arm phase II study in Korea. RR was 50%, PFS was 8.2 months, mOS was not reached. Osimertinib activity in patients with uncommon mutations was assessed also in a retrospective US study, time on treatment ranged from 7.7 months to 19.3 months.

This is a multi-centric, retrospective, real-world study. Study goal is to collect high quality data regarding the efficacy of osimertinib in TKI naive NSCLC patients with uncommon EGFR mutations. The primary endpoints are progression-free survival and overall survival, from osimertinib start. Secondary endpoints would be RECIST response, adverse events, time on treatment and time to CNS progression, CNS response and mechanisms of resistance if tested.

The study includes researchers from Belgium, Denmark, Israel, Switzerland, Netherlands, Germany, France, Italy and USA. Data collection will be conducted at each participating site, following ethics approval. No patient identifying information will leave each of the participating centers. Data will be collected centrally by the lead investigators and analyzed for the entire study cohort and for subgroups if deemed appropriate.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. NSCLC by histologic or cytologic diagnosis
3. Stage IV or stage III not amendable to curative treatment (i.e., advanced disease)
4. Uncommon mutation of EGFR (exon 20 insertion excluded)
5. Treated with osimertinib for advanced disease as first TKI
6. Osimertinib initiated not later than end of January 2021

Exclusion criteria:

1. Lack of any follow-up data
2. Lack of consent for data collection or ethics committee approval for the waiver of informed consent (i.e. for deceased patients)
Psoriatic Arthritis Research Collaborative: Biologic Sub-Study

Psoriatic arthritis (PsA) is an inflammatory arthritis with substantial variation in clinical features. We propose a multicenter collaborative approach to better understand the phenotypes and current management of PsA in the United States.The central goal of this proposal is to obtain the data necessary to design a pragmatic trial in PsA.

Psoriatic arthritis (PsA) is a chronic inflammatory arthritis that can be associated with devastating outcomes including irreversible joint damage. The management of a patient with PsA is extremely challenging due to the high degree of phenotypic heterogeneity. The ultimate goal of this proposal is to prepare pragmatic trials in PsA trials that will encompass all relevant subgroups of patients. The aims of this study specifically focus on responses to biologic therapy among patients with PsA and determining the optimal set of outcome measures for PsA trials.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-89
* Active PsA (at least one swollen joint or enthesitis) -Meet CASPAR criteria (Table 2) (103) -Initiation of TNFi (etanercept, adalimumab, infliximab, certolizumab, golimumab) (At the time of the submission, TNFi biosimilars have been approved by the FDA but are not available on the US market. Once available, patients starting TNFi biosimilars will similarly be eligible for participation. Patients may have been on the medication in the past but must have had greater than 2 months off the medication.Patients may be taking other traditional DMARDs. A washout period is not required.)

Exclusion Criteria:

* Unable to give informed consent
* Out of the age range
* Switching therapies for skin psoriasis in the setting of well controlled joint and enthesis symptoms.
* Patients with only active PsA
Quality Initiative to Improve Glucose Control in Type 2 Diabetic Patients

The goal of the Twine / University of Michigan Diabetes Quality Improvement Initiative is to improve diabetes care quality using real time feedback with continuous glucose monitoring (CGM) and dietary coaching for lower carbohydrate consumption in a high-risk sub-cohort of outpatients with type 2 diabetes (T2D).


Eligibility Criteria:
Inclusion Criteria:

* Michigan Medicine patient treated by a physician in the Family Medicine Department at the Chelsea Health Center
* Diagnosis of T2D as recorded in the patient's problem list or as documented by medication list and lab results
* HbA1C \>8 for the high-risk sub-cohort

Exclusion Criteria:

* Individuals for whom tight control (ie A1C \< 8) is not safe or recommended, including but not limited to older frail individuals at high-risk of hypoglycemia and falls or those with a life expectancy of less than 6 months due to a comorbid condition
* Individuals with cognitive or psychological diagnoses that might make CGM or low carbohydrate dieting risky, such as patients with eating disorders, uncontrolled psychotic - mental illness or those patients with dementia
* Women who are pregnant or breast feeding
* Individuals who had previous bariatric surgery
A Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer

To evaluate the efficacy of Surufatnib combined withcamrelizumab, nab-paclitaxel, and gemcitabine versus nab-paclitaxel plus gemcitabine as the first-line treatment in metastatic pancreatic cancer

This is a multicenter, randomized, open-label, active-controlled, phase II/III trial to evaluate the efficacy and safety of surufatinib combined with camrelizumab, nab-paclitaxel, and gemcitabine versus nab-paclitaxel plus gemcitabine as the first-line treatment in metastatic pancreatic cancer

Eligibility Criteria:
Inclusion Criteria:

1. Fully understand and voluntarily sign an informed consent form, willing and able to follow the study process;
2. Age range is 18-75 years old (inclusive);
3. Pancreatic cancer confirmed by histology or cytology;
4. Stage IV metastasis Pancreatic cancer patients;
5. Have not received previous systematic anti-tumor treatment in the stage of metastatic pancreatic cancer;
6. According to RECIST 1.1, there is at least one measurable lesion;
7. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1;
8. Expected survival time ≥ 12 weeks;

Exclusion Criteria:

1. Use of systematic anti-tumor therapy within 4 weeks prior to the first dose；
2. Presence of other malignancies in the past 3 years;
3. Received major surgical surgery within 60 days before the first dose;
4. Have received any surgery or invasive treatment within 4 weeks before the first use of the drug;
5. Received palliative radiotherapy within 1 week before the first dose; received radical radiotherapy within 4 weeks before the first dose;
6. Any known allergy to surufatinib or its components, camrelizumab, nab-paclitaxel, or gemcitabine;
7. Received inducers or inhibitors of cytochrome P450 (CYP) 3A and CYP2C8 within 2 weeks or 5 half-lives (whichever is longer) before the first dose;
8. Use of immunosuppressive drugs within 4 weeks before first dose;
9. Known history of clinically significant liver disease, including active viral hepatitis infection or other active hepatitis or clinically significant moderate to severe cirrhosis;
10. Patients who currently have hypertension that cannot be controlled by medication;
Study About Preventive Treatment of Folliculitis Induced by Epidermal Growth Factor Receptor Inhibitors

Patients will receive local prophylactic treatment (Diprosone cream) during 8 weeks from the beginning of the EGF-R inhibitors treatment, on the areas of the body susceptible to be affected by folliculitis.


Eligibility Criteria:
Inclusion Criteria:

* Indication of Cetuximab in patients with metastatic colorectal cancer in association or not with irinotecan, after failure of a chemotherapy treatment with Irinotecan OR
* Indication of Erlotinib, in patients with metastatic Non-Small-Cell Lung Carcinoma, after failure of at least one chemotherapy treatment
* No pre-existing cutaneous toxicity

Exclusion Criteria:

* Contraindication to local corticotherapy
* Previous history of severe hypersensibility reactions (Grade III or IV) due to Cetuximab, Irinotecan or Erlotinib
* Betamethasone or one of excipient product allergy