cyrilzakka/clinical-trials huggingface dataset:
Study of E7777 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma and Cutaneous T-cell Lymphoma

The purpose of this study is to evaluate the objective response rate (ORR) of E7777 in participants with relapsed or refractory peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL).

This is a multicenter, single-arm, open label, Phase 2 to evaluate efficacy, safety, pharmacokinetics and immunogenicity of E7777 in participants with relapsed or refractory PTCL and CTCL.

Eligibility Criteria:
Inclusion Criteria:

1. Participants who have histological diagnosis as peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL).
2. Participant who have measurable disease.
3. Participant who had previous systemic chemotherapy.
4. Participant who had disease progression (PD) or did not have response (complete response (CR) or partial response (PR)) in systemic chemotherapy, or relapsed or progressed after systemic chemotherapy.
5. Participant with Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
6. Participant with adequate renal, liver and bone marrow function.
7. Male and female participants ≥20 years of age at the time of informed consent.
8. Participants who have provided written consent to participate in the study.

Exclusion Criteria:

1. Participant with serious complications or histories.
2. Participant with history of hypersensitivity to protein therapeutics.
3. Participant who is positive for Human immunodeficiency virus (HIV) antibody, Hepatitis C virus (HCV) antibody, or Hepatitis B Surface (HBs) antigen.
4. Participant with malignancy of activity other than PTCL or CTCL within 36 months before informed consent.
5. Women of childbearing potential or man of impregnate potential who don't agree to use a medically effective method for contraception.
6. Woman who is pregnant or lactating.
7. Participant with allogeneic stem cell transplantation.
8. Participant who were decided as inappropriate to participate in the study by the investigator or sub-investigator.
Mobile Smoking Cessation Intervention in Enhancing Cancer Outreach in Low-Income Adult Smokers

This trial studies how well a mobile smoking cessation intervention works in enhancing cancer outreach in low-income adult smokers. Mobile smoking cessation intervention may help smokers quit or cut back on smoking, and help increase the range of cancer prevention services provided to low-income adult smokers.

PRIMARY OBJECTIVES:

I. Compare the efficacy of three smoking cessation interventions targeting community based low-income uninsured and underinsured individuals in a group-randomized trial.

II. Evaluate the role of quit motivation, nicotine withdrawal, risk perception, self-efficacy, social support, and negative affect as potential mediators of smoking abstinence.

III. Compare the cost-effectiveness of the three treatment conditions.

OUTLINE: Participants are randomized to 1 of 3 groups.

GROUP I (STANDARD CARE): Participants undergo standard of care smoking cessation intervention consisting of brief advice to quit smoking, nicotine replacement therapy (NRT), and self-help written materials.

GROUP II (ENHANCED CARE): Participants undergo standard of care smoking cessation intervention as in Group I and attend a health feedback counseling session at baseline. Participants also receive access to a smoking cessation hotline telephone number and supportive text messages daily for 12 weeks.

GROUP III (INTENSIVE CARE): Participants undergo standard of care smoking cessation intervention as in Group I and attend a health feedback counseling session at baseline. Participants also receive access to a smoking cessation hotline telephone number, supportive text messages daily for 12 weeks, and a smoking cessation telephone call over 15 minutes weekly for 12 weeks.

After completion of study, participants are followed up at 3, 6, and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Smoked at least 100 cigarettes in lifetime
* English or Spanish speaking
* Currently smoking at least 5 cigarettes a day, on average
* Willing to set a quit smoking date within a week of the enrollment

Exclusion Criteria:

* Positive history of a medical condition that precludes use of the nicotine patch
* Current use of nicotine replacement therapy (NRT)
* Current use of other smoking cessation medications (e.g., Chantix or Zyban)
* Pregnant or nursing
* Enrolled in another smoking cessation study
Drugs for the Treatment of Multiple Sclerosis and Risk of Cancer: a Pharmacovigilance Analysis in Vigibase

Even though the therapeutic panel for multiple sclerosis (MS) treatment has improved in the last 20 years, safety data especially for the second-line and innovative treatments are lacking. The association between MS and cancer has long been investigated but has led to conflicting results. No studies have reported an increased risk of cancer after long-term exposure to immuno-modulators. The present study will assess whether drugs for the treatment of MS are associated with an increased risk of cancer by analyzing the disproportionality of reports in the World Health Organization (WHO) pharmacovigilance database.

A case non-case study using Vigibase®, the World Health Organization Global Individual Case Safety Reports (ICSRs) database which includesreports forwarded to the WHO Uppsala Monitoring Center by national pharmacovigilance systems from over 130 countries around the world since 1967. Information on the adverse effects reported include patient demographics and medical relevant history, drugs recorded according to the WHO Drug dictionary and adverse drug reactions coded with Medical Dictionary for Regulatory Activities (MedDRA) terms will be perform.

Eligibility Criteria:
Inclusion Criteria:

* Serious cases reported in the World Health Organization (WHO) database of individual safety case report from 2000 to September 2019
* Cancer overall reported by a term included in the Standardized MedDRA query (SMQ) "Malignant tumours"

Exclusion Criteria:

- Non serious cases
Induction Chemotherapy and Toripalimab for Larynx Preservation in Resectable Laryngeal/Hypopharyngeal Carcinoma

The aim of this study is to define whether combination of induction chemotherapy and PD-1 inhibitor (Toripalimab) improve the rate of larynx preservation, for patients with resectable laryngeal/hypopharyngeal carcinoma.

Historically, induction chemotherapy could provide a chance of larynx preservation for approximate 60-70% of patients with locally advanced laryngeal/hypopharyngeal carcinoma. Recently, phase I-II clinical studies demonstrated excellent pathological response of induction PD-1 inhibitor with/without chemotherapy for locally advanced head and neck cancer. The aim of this study is to define whether combination of induction chemotherapy and PD-1 inhibitor (Toripalimab) improve the rate of larynx preservation, for patients with resectable laryngeal/hypopharyngeal carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed, resectable locally advanced laryngeal/hypopharyngeal squamous cell carcinoma (T2-4a, N0-resectable N3, M0);
* Age between 18-75 years;
* Signed inform consent;
* Had at least one measurable lesion according to RECIST 1.1 criteria
* Anticipated overall survival more than 3 months;
* Satisfactory performance status: ECOG (Eastern Cooperative Oncology Group) scale 0-1;
* Normal organ function;
* HBV DNA\<500 IU/mL（or 2500 copies/mL）and HCV RNA negative ;
* Male and no pregnant female, able to adapt birth control methods during treatment.

Exclusion Criteria:

* Hypersensitivity to Toripalimab, Paclitaxel, Nab-Paclitaxel and Cisplatin;
* Suffered from malignant tumors, except cervical carcinoma in situ, papillary thyroid carcinoma, or skin cancer (non- melanoma) within five years;
* Severe, uncontrolled heart disease;
* Receive vaccine or live vaccine within 28 days prior to signing the informed consent;
* Equivalent dose more than prednisone 10mg/d or other immunosuppressive treatments within 28 days prior to signing the informed consent;
* Surgery or trauma within 28 days prior to signing the informed consent;
* Received other immune checkpoint inhibitors previously;
* Severe, uncontrolled infections within 28 days of prior to signing the informed consent;
* Active, known or suspected autoimmune disease; Type I Diabetes, hypothyroidism those only need hormone replacement therapy, vitiligo or inactive asthma who don't need systemic therapy can recruit;
* History of interstitial lung disease;
* HIV positive;
* Hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥500IU/ml, or 2500cps/ml; Positive HCV RNA;
* Other diseases which may influence the safety or compliance of the clinical trial, such as mental illness, or their family and society factors;
* Women of child-bearing potential who are pregnant or breastfeeding.
an Istitution Experience on Parosteal OsTeosarcoma

single institution cases series review of histological and clinical data

Investigators will review all the cases with a diagnosis of primary parosteal osteosarcoma treated at the Rizzoli Institute from 1900 up to 31 July 2018, retrospectively.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients treated at Rizzoli Institute from 01 Jan 1900 to 31 Jul 2018
* Diagnosis of parosteal osteosarcoma
* Written informed consent prior to any study-specific analysis and/or data collection

Exclusion Criteria:

• Patients with histological diagnosis different from parosteal osteosarcoma
Study to Determine the Efficacy, Safety, Tolerability & Pharmacokinetics of RO 205-2349 in Patients With Type 2 Diabetes Mellitus

The objective of the study is to determine the dose(s) of Ro 205-2349 which, when compared to placebo, are efficacious, safe and tolerable in improving glycemic control in patients with type 2 diabetes. Doses of 2 to 5 mg/day will be studied.


Eligibility Criteria:
Inclusion Criteria:

* Age 35 to 75
* Type 2 diabetes for longer than 3 months
* HbA1c (glycosylated hemoglobin A1c) greater than 7.0% at screening
* FPG (fasting plasma glucose) greater than 126 mg/dL at screening
* BMI (body mass index) less than 40 kg/square meter

Exclusion Criteria:

* Type I diabetes
* Type 2 diabetes patients currently treated with insulin
* Type 2 diabetes patients currently or previously treated with Actos, Avandia or Rezulin
* FPG (fasting plasma glucose) greater than 270 mg/dL at baseline
* Impaired liver or kidney function
* Triglycerides greater than 600 mg/dL
* Uncontrolled hypertension
* Pregnant or lactating women
* Women not using adequate contraception
Study of Iguratimod in Sjögren's Syndrome

A single-center, self-control, open-label study of efficacy and safety of Iguratimod in patients with Sjögren's Syndrome

In this study, patients with Sjögren's Syndrome are enrolled and received Iguratimod 25 mg twice a day for 24 weeks. The differences of ESSPRI (EULAR Sjogren's Syndrome Patient Reported Index) score, ESSPRI(EULAR Sjogren's Syndrome Patient Reported Index) score, unstimulated salivary flow rate, Schirmer's test SF-36 score and HAQ score between baseline and week 24 are evaluated to determine the efficacy of Iguratimod in patients with Sjögren's Syndrome.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of Sjogren's syndrome according to the revised American-European Consensus Group (AECG) criteria
* Positive dry eyes and (or) dry mouth symptoms
* Hyperglobulinemia

Exclusion Criteria:

* Complicated with other systemic autoimmune diseases
* Severe complications of Sjogren's syndrome
* Glucocorticosteroid therapy, systemic immunosuppressant therapy, or biological agents therapy within 3 months prior to the screening visit
* Active infections or chronic infectious diseases
* A history of malignancies
* Pregnancy or breathfeeding
* Inability to comply with the study protocol for any other reason
Efficacy of Corticosteroids to Treat Outpatients With Acute Exacerbations of COPD

Primary objective:

The aim of this study is to determine the efficacy and safety of five days of oral corticosteroids (40 mg / day) for the treatment of acute exacerbations of COPD (AECOPD) in outpatients.

COPD is a major and growing public health issue. The vast majority of cases are cared for in primary care, both for follow-up in stable state and for treatment of exacerbations, which represent major events in the natural history of the disease.

Systemic corticosteroid treatment is often proposed for exacerbations treatment, although guidelines in this area are heterogeneous regarding precise indications of this treatment. The latest data from the literature, seems to show efficacy of oral corticosteroids but involved only patients seen at the hospital. General practitioners need evidence-base informations to choose whether or not they have to give oral corticosteroids to their patients ; therefore it is very important to better define the benefit-risk ratio and precise indications of oral corticosteroids as part of the care for COPD exacerbations.

The investigators built a randomized double-blind controlled trial to answer this question.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 40 years and over
* Smoking ≥ 10 pack-years
* Patients with suspected acute exacerbation of COPD
* Patients who gave their written informed consent to participate in the study

Exclusion Criteria:

* Known or suspected chronic respiratory disease other than COPD (asthma, bronchiectasis ...)
* Suspected pneumonia or pulmonary oedema
* Decision of hospitalization
* Patients taking oral corticosteroids running or stopped for less than a week before inclusion
* Pathology compromising compliance
* Fever unexplained by the current AECOPD
* Uncontrolled hypertension
* Uncontrolled diabetes
* Deep infectious disease
* History of ancient untreated tuberculosis
* Untreated peptic ulcer
* Unhealed wound
* Ulcerative Colitis
* Allergy to steroids
* Any severe or uncontrolled infections who are not specified as therapeutic indication in the SPC (Summary of Product Characteristics)
* Hepatitis, acute genital herpes, varicella, acute zoster
* Live attenuated vaccine, recent or planned
* Psychoses not controlled by treatment
* Hypersensitivity to prednisone or any of the excipients of Cortancyl®, including lactose intolerance
* Patients who have already been included in BECOMEG
* Patients who have to move within 8 weeks after inclusion in the study
* Patients who are not affiliated to the national health insurance
Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke

The study is designed to examine the safety, tolerability, and activity of a combination of microbubbles (perflutren lipid microsphere \[Definity®\]) and continuous monitoring with 2 MHz transcranial Doppler ultrasound (TCD) as an adjunctive therapy to tissue plasminogen activator (tPA) treatment in subjects with acute ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

* Measurable focal neurological deficit (National Institutes of Health Stroke Scale \[NIHSS\] score \> 4 points)
* tPA eligible
* Occlusion of the middle cerebral artery

Exclusion Criteria:

* Right to left cardiac shunt
* Uncontrolled hypertension
* Absent temporal windows
Effectiveness of Neurodinamic Techniques on Radial Nerve for the Treatment of Lateral Epicondylalgia

Lateral elbow pain is a prevalent musculoskeletal disorder in the working population due to overuse of the upper limb. This pathology has serious consequences for health, work performance and overall health burden.

In this injury, as in any musculoskeletal disorder, the peripheral nervous system is involved. Because of its course and corresponding motor and sensory innervation in the area, the radial nerve should be taken into consideration as a structure involved in elbow pain.

The aim of the present study is to demonstrate which of the neurodynamic techniques is more effective in lateral epicondylalgia, neural tension techniques or neural mobilization techniques.

The aim of the present study is to demonstrate which is more effective among the neurodynamic techniques for lateral epicondylalgia, neural tension techniques or neural mobilization techniques.

A total of 60 subjects will be recruited and divided into 2 groups. 30 in Group 1 where they will receive a neural mobilization technique on the radial nerve and 30 in Group 2 where they will be subjected to a neural tension technique on the radial nerve.

The data to be collected will be grip strength, pain on pressure, pain and quality of life dash questionnaire, these data will be measured pre, post treatment and a re-evaluation at 4 weeks and 24 weeks after the intervention.

The duration of the treatment is 6 weeks, performing two sessions per week with 72 hours of rest between sessions. A total of 12 sessions will be carried out.

Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed with lateral epicondylalgia.
* Experiencing elbow pain of 2 to 6 months duration.
* Age between 30 and 60 years old.
* Radial humeral joint tenderness to palpation.
* Positive Cozen\&#39;s test

Exclusion Criteria:

* - Bilateral symptoms.
* Rheumatologic disease involving the elbow and wrist
* Musculoskeletal disorder due to connective tissue pathology
* Cervical radiculopathy
* Nerve compression including the upper extremity
* Operation on the affected arm
* Having received treatment for epicondylalgia in the last 6 months
* Radiating pain from the cervical spine
* Instability of the external ligamentous complex of the elbow(3).
* Not having received any physiotherapy session in the month prior to the start of the study.
* Neural clinical manifestations (electric shock-like pain, tingling, tingling, numbness and/or burning).
A Study to Evaluate the Safety of FluMist in Healthy Children and Healthy Adults

The purpose of this study was to expand the data describing the safety profile of FluMist in the indicated populations (5-8, 9-17, and 18-49 years of age) and to assess the safety of annual revaccination in those who received FluMist in 2 or more consecutive years.

The primary objective of this study was to assess the safety of FluMist vaccination by comparing the rates of medically attended events (MAEs) (including serious adverse events \[SAEs\], anaphylaxis, urticaria, asthma, wheezing, pre-specified grouped diagnoses, and rare events potentially related to wild-type influenza) in FluMist recipients to rates in multiple non-randomized control groups.

Eligibility Criteria:
Inclusion Criteria:

* 5-49 years of age
* Members of the Kaiser Permanente (KP) Health Care Plan within KP of Northern California, KP of Colorado, and KP of Hawaii

Exclusion Criteria:

* Must not have had any high risk underlying medical conditions, includig asthma
Effectiveness of Core-Needle US Guided Biopsy as Primary Tool For Diagnosis of Thyroid Nodules

The study aimed to determine the best intervention between Core biopsy and Fine needle aspiration in diagnosis of thyroid malignancy.


Eligibility Criteria:
Inclusion Criteria:

* patients with nodules larger than 1 cm in diameter and suspicious ultrasound criteria with TIRADS category III or higher.

Exclusion Criteria:

* Patients with a history of hemodynamic instability or inadequate coagulation profile were excluded
Effects of Breathing Exercises Combined With Endurance and Strength Training in Patients With Cystic Fibrosis.

Cystic fibrosis (CF) is a multi-system inherited disease. It's a common autosomal recessive illness. It mostly affects the lungs, liver, and pancreatic exocrine glands, as well as the intestines. The production of viscous mucus and an environment prone to chronic airway blockage. This allows harmful microorganisms to infect the lungs. The role of Exercise as a prognostic indicator or therapeutic aid is important in CF research around the world. The objective of this study is to find out the Effects of Breathing Exercises Combined with Endurance and Strength Training on Dyspnea and Quality of Life of patients with Cystic Fibrosis. It will be Quasi Experimental study. Treatment will be given to all participants 3 sessions in a week for 4 weeks. Pre and Post treat-meant evaluation will be checked by CFQ-R+14. All patients will be treated with exercise program of Active cycle breathing techniques(ACBT), Pursed lip breathing, Endurance Exercise 20 to 30 min ( walking, cycling) and strength training with Thera-Bands (Bilateral arm raising, Bilateral knee extension). Exercise capacity will be measured with 6MWT. Dyspnea and fatigue will be measured with Borg scale.


Eligibility Criteria:
Inclusion Criteria:

* Age 14-50 years
* Male and female both will be included
* clinically stable
* Shortness of breath on effort

Exclusion Criteria:

* smoking history \>10 years
* clinical diagnosis of asthma
* Physical and psychological disability preventing participation
* medical condition which could place individuals at risk during exercise training
PROARTE -PROstate ARTery to Reduce the Symptoms of Benign Prostatic Hyperplasia

This is a trial to demonstrate the superiority of prostate artery embolization (PAE) over sham procedure in men with benign prostatic hyperplasia (BPH) induced lower urinary tract symptoms (LUTS). The trial will aim to enroll 108 patients at a 2:1 allocation over a 2 year period.


Eligibility Criteria:
Inclusion Criteria:

* • Men ≥45 and ≤90 years presenting with benign prostatic hyperplasia with symptoms for at least 6 months that are refractory to medical management or in whom medications are contraindicated, not tolerated, or refused.

  * International Prostate Symptom Score (I-PSS) score 14 or greater.
  * Quality of Life (QoL) score ≥ 3
  * Peak urinary flow (Qmax) less than or equal to 12 mL/s with void volume \>125mL.
  * Prostate volume greater than 30 cc as determined by ultrasound, MRI, or CT.
  * Personal risk \<40% based on the University of Texas San Antonio prostate cancer risk calculator or having a negative prostate biopsy for cancer within the last 24 months.
  * Able to provide written consent.
  * Not participating in any other investigational drug or device studies.

Exclusion Criteria:

* • History of biopsy-proven prostate cancer

  * Renal insufficiency (glomerular filtration rates (GFR) less than 40mL/min/1.73 m2 who are not already on dialysis)
  * Prior prostate surgery or intervention, including trans-urethral resection of the prostate, balloon dilation, stent implantation, laser prostatectomy, radiation, UroLift®, or hyperthermia
  * Other bladder or urethral pathology requiring therapy, either in the past or currently, including neurogenic bladder, sphincteric abnormalities, bladder cancer, or other causes of bladder atonia.
  * Other causes of urinary obstruction, such as strictures of urethra or ureters, not related to BPH
  * Current decompensated congestive heart failure, uncontrolled diabetes mellitus, significant respiratory disease, or known immunosuppression.
  * Neurological disease, including multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease, and previous spinal nerve surgery
  * Patients with platelet count \<50,000/μL or International Normalized Ratio (INR) \>1.8, unless corrected for the procedure
  * Active urinary tract infection. Patients must have a negative culture within 7 days of the procedure.
  * Allergy to iodinated contrast agents unless pre-treated by corticosteroids.
  * Acute urinary retention.
  * Post void residual (PVR) \> 250 mL with urodynamic evidence of atonic bladder. Patients with a PVR \>250 but urodynamic testing consistent with obstruction will be allowed.
  * Bladder stone within three months prior to the procedure.
  * Hematuria not evaluated by Urologist for causes other than BPH.
  * Previous rectal surgery (excluding hemorrhoidectomy) or history of rectal disease.
  * Prior pelvic irradiation or radical pelvic surgery.

Imaging exclusion criteria:

• Internal iliac artery occlusion as determined by either CT or MRI.