cyrilzakka/clinical-trials huggingface dataset:
Safety Study to Evaluate Induction and Consolidation Treatment in Patients With Mantle Cell Lymphoma (LCM-04-02)

Mantle Cell Lymphoma (MCL) is a malignancy with a poor response to treatment and with a median survival of 2- 4 years since diagnosis. Although histology is similar to that of an indolent lymphoma, MCL is currently considered an aggressive tumour. Few prospective therapeutic trials have been reported in MCL, and results are difficult to interpret due to treatment heterogeneity. It is known that standard chemotherapy for other clinically aggressive lymphomas yields poor results. Recently, better results have been communicated with intense induction chemotherapy treatments or consolidating the response with high dose chemotherapy with stem cell support. Keeping in mind these considerations, we will use and intensive induction treatment with Hyper-CVAD/MTX-AraC associated with anti-CD20 in order to increase the overall response rate followed by consolidation treatment with Ibritumomab -tiuxetan (Zevalin) with the aim of eradicate the minimal residual disease, responsible of relapse.

Study Design:

* The Patients will receive 6 cycles of induction chemotherapy as follows: Anti-CD20/Hyper -CVAD chemotherapy will be alternated with anti-CD20 +MTX/Ara-C chemotherapy. After 4 cycles (2 x2), response will be evaluated. If response (complete or partial) is observed, 2 additional cycles will be administrated. If less than a partial response is observed, the patient will be out of the study.
* Consolidation treatment will be a single dose of Y90Ibritumomab -Tiuxetan (Zevalin) will be administered after 12 weeks after completion of induction chemotherapy. The initial dose of Zevalin will be 0.3 mCi/kg, to be further escalated to 0.4 mCi/Kg if unacceptable toxicity does not occur.

Eligibility Criteria:
Inclusion Criteria:

* All histologic MCL subtypes (WHO classification)
* Age between 18 and 70 years old
* Performance status 0 to 2 (ECOG)
* Cardiac ejection fraction \>50%
* Adequate organ (hepatic, cardiac and renal) and marrow function: Hb\> 10g/dl, neutrophil counts\> 1500/ µl, platelet\> 100000/ µl. Creatinine \< 2,5xULN, bilirubin, AST or ALT\<2,5xULN.
* For Y90-ibritumomab tiuxetan administration: Bone Marrow Infiltration by lymphoma cells \< than 25% ; platelet count \>100,000/µl and neutrophil counts \>1500/µl
* Informed consent should be obtained

Exclusion Criteria:

* Ann Arbor stages I or II without B symptoms or bulky disease (\>10 cm).
* Previous chemotherapy or radiotherapy treatment.
* Uncontrolled current illness: Hepatic, renal, cardiovascular, neurological or metabolic illness.
* Symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia.
* HIV, HBV or HCV positive serology.
* Limitation of the patient´s ability to comply with the treatment or follow-up protocol.
* Men and women with reproductive potential who are not using effective contraceptive methods during and at least 12 months after the end of the study
* Acute or chronic active infection.
* Known hypersensitivity to some of the drugs or other related compounds
* No informed consent obtained
Effect of Incidental Findings Information on Lung Cancer Screening Intent

This online randomized controlled trial seeks to determine if inclusion of incidental findings information in a lung cancer screening decision aid affects screening intent among screening-eligible individuals. Participants will view either a decision aid with incidental findings information or without and indicate their intent to pursue lung cancer screening.

Hypothesis: Inclusion of incidental findings in a decision aid will decrease intent to screen among participants.


Eligibility Criteria:
Inclusion Criteria:

* 55-80 year old male or female
* Current or former smoker who quit within the last 15 years
* At least 30 pack years of smoking

Exclusion Criteria:

* N/A
A Study of the Elopement Prevention and Safety Training Program

The purpose of this study is to demonstrate the feasibility of the Elopement Prevention Safety (EPST) program in children with autism spectrum disorder (ASD) who have engaged in eloping. This is a program created by the Behavior Treatment Clinics to help caregivers come up with a safety plan to prevent their children from running away or wandering off.

A large number of children with autism spectrum disorder (ASD) have a current or past history of elopement. For parents of a child with ASD, having their child go missing is potentially dangerous and far more likely compared to typically developing children. This behavior interferes with household routines, engenders vigilance, and restricts the family's participation in their community. Such restrictions contribute to the family's isolation and hinders development of community supports. Elopement can result in injuries and deaths of children with ASD.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females, ages 4 to 12 inclusive
2. Diagnosis of ASD as determined by clinical interview and supported by standardized measures (i.e., Autism Diagnostic Observation Schedule-2, Vineland, Stanford-Binet V)
3. Engages in elopement in the form of bolting or wandering, as determined by structured interview
4. A caregiver who expresses a willingness to participate in treatment and complete baseline/outcome assessments.

Exclusion Criteria:

1. Unmanaged psychopathology or problem behavior other than elopement that warrants immediate clinical care, determined by clinical interview and Aberrant Behavior Checklist (ABC)
2. Child and family currently in therapy that is likely to be redundant with the treatment program or interfere with proposed treatment
3. Presence of both of the types of elopement under investigation (i.e., both bolting and wandering).
Dose Escalation of Icotinib in Advanced Non-small Cell Lung Carcinoma (NSCLC) Patients Evaluated as Stable Disease

The primary purposes of this study are to assess the safety and efficacy of using high doses of the drug Icotinib (Conmana) as a way to treat patients with non-small cell lung cancer that achieve stable disease after 8 weeks routine therapy.

This is a multi-center phase II randomized controlled study to assess the safety and efficacy of using high doses of the drug Icotinib (Conmana) as a way to treat patients with non-small cell lung cancer that achieve stable disease after 8 weeks routine therapy by PFS, as well as OS and DCR. The adverse events and adverse reaction are evaluated as well.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients confirmed by sputum cytology)
* No previous targeted treatment such as gefitinib, erlotinib.
* With a measurable disease(longest diameters \>=10mm with Spiral computed tomography (CT)and \>=20mm with conventional CT) at least according to RECIST Criteria
* WHO performance status(PS)\<= 2
* N\>=1.5×109/L, Plt\>=1.0×109/L,Hb\>=10g/dL;AST\&ALT should \<3ULN(without liver metastasis) or \<5ULN(with liver metastasis).TBIL\<=1.5ULN.
* Signed and dated informed consent before the start of specific protocol procedures.

Exclusion Criteria:

* Allergic to icotinib
* Patients with metastatic brain tumors with symptoms.
* Experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as gefitinib, erlotinib or Cetuximab.
* Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
A Repeated Instruction by Telephone on the Day Before Colonoscopy to Patients Undergoing Colonoscopy

Cell phone retell the instruction of bowel preparation on the day before colonoscopy would help patient to prepare for colonoscopy and improve the quality of the bowel preparation.

Colonoscopy is the gold standard in the diagnosis of colorectal disease. The success of colonoscopy depends on high-quality bowel preparation by patients. Inadequate bowel cleansing reduces the speed, the cecal intubation rate, and the number of polyps detected. It also increases costs, mostly due to repeated procedures. The quality of bowel cleansing has remained suboptimal even though numerous different products and regimens have been tested and compared in no fewer than six meta-analyses. Therefore, a completely different approach to improve precolonoscopy bowel cleansing is welcome.

There are many factors effect the bowel preparation such as age, cirrhosis diabetes, drug compliance, cerebral infarction, dementia, history of major surgery. 20% of patients with poor bowel preparation were due to bad compliance. Studies found that addressing patient perceptions with an inexpensive and simple booklet based on the Health Belief Model improved preparation quality. We assume that doctor retelling the instruction of bowel preparation by cell phone on the day before colonoscopy would help patient to prepare for colonoscopy and improve the quality of the bowel preparation.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing colonoscopy

Exclusion Criteria:

* disturbance of water and electrolyte
* history of colorectal surgery
* severe colonic stricture or obstructing tumor
* known or suspected bowel obstruction or perforation
* toxic colitis or megacolon
* dysphagia
* compromised swallowing reflex or mental status
* significant gastroparesis or gastric outlet obstruction or ileus
* severe chronic renal failure (creatinine clearance \<30 mL/minute)
* severe congestive heart failure (New York Heart Association class III or IV)
* uncontrolled hypertension (average systolic blood pressure \>170 mm Hg, average diastolic blood pressure \>100 mm Hg)
* pregnant or lactating women
* patients who cannot give informed consent
Effectiveness of Vedolizumab in CD Patients Naïve to Anti-TNF

Anti-cytokine antibodies, such as Infliximab (an anti TNF alfa chimeric antibody) and Adalimumab (an anti TNF alfa humanize antibody), have been developed and used in clinical practice for the treatment of patients with Crohn disease (CD). Unfortunately, their efficacy is limited. Based on these concepts, a new drug has been developed for IBD treatment. Vedolizumab (VDZ) is able to recognize the α4β7 heterodimer, and selectively blocks gut lymphocyte trafficking.

The hypothesis of this study is that VDZ therapy may be to halt CD disease progression during time and modifying its natural history, using Lemann Index.

All patients who will enter in the study will be follow-up at weeks 2-6-14-22-30-38-46 or before in case of relapse. A relapse will be defined by an Harvey Bradshaw Index ≥ 5 for 2 consecutive weeks. The following data are to be recorded:

1. Physical examination
2. Adverse Event Review
3. Weight in Kg
4. Full blood count
5. Biochemical series including serum iron, serum ferritin, C reactive protein (PCR), ESR (eritrosedimatation rate)
6. Fecal Calprotectin
7. VDZ fecal loos
8. VDZ trough levels and antidrug antibodies
9. Current treatments

The last visit will be performed at week 54. The following data are to be recorded:

1. Physical examination
2. Adverse Event Review
3. Weight in Kg
4. Full blood count
5. Biochemical series including serum iron, serum ferritin, C reactive protein (PCR), ESR (eritrosedimatation rate)
6. Fecal Calprotectin
7. VDZ fecal loos
8. VDZ trough levels and antidrug antibodies
9. Current treatments
10. Routine lower and upper gastrointestinal endoscopy and magnetic resonance imaging or computed tomography of the small bowel
11. SES-CD
12. Lemann Index

Eligibility Criteria:
Inclusion Criteria:

* Have given written informed consent to participate
* Be aged between 18 and 80
* Have a moderate/severe CD defined by an HBI \>7 CD

Exclusion Criteria:

* previous treatment with anti-TNF drugs,
* concomitant use of immune-modulator drugs for CD (azathioprine/6-mercaptopurine, methotrexate)
* ulcerative colitis (UC) or inflammatory bowel disease undetermined (IBD-U) diagnosis
* symptomatic obstructive disease
* bowel resection within the past 6 months
* ileostomy
* extensive small bowel resection (as determined by the investigator) or a short bowel syndrome
* patients who are currently receiving total parenteral nutrition
* history of cancer in the past 5 years
* pregnancy known at the study inclusion
* positive Clostridium difficile stool assay
* Listeria, human immunodeficiency virus, central nervous system demyelinating disease, untreated tuberculosis
Improving Nighttime Access to Care and Treatment; Part 2- Ghana

Globally, leading causes of death among children one month to 5 years old are pneumonia, diarrheal disease and malaria which are treatable early in the disease-course with low-cost medications. However, these diseases can progress to emergencies when access to care is delayed. In response, a telemedicine and medication delivery service (TMDS) was designed to improve nighttime access to pediatric care and treatment. The TMDS will be implemented in three distinct Ghanaian community to evaluate the clinical safety, operational feasibility of implementing,and scalability of the service.

Globally, leading causes of death among children one month to 5 years old are pneumonia, diarrheal disease and malaria which are treatable early in the disease-course with low-cost medications. However, these diseases can progress to emergencies when access to care is delayed. In response, a telemedicine and medication delivery service (TMDS) called MotoMeds was designed to overcome barriers to seeking care. MotoMeds targets the nighttime period when barriers to accessing care are highest. The TMDS was initially deployed in Haiti and will now be evaluated for generalizability and portability in Ghana.

The study objectives are to assess clinical safety and logistical feasibility of the TMDS. The study population is children in Accra and Tamale. The workflow consists of parents/guardians calling the TMDS on their child's behalf, Emergency Medical Technicians (EMTs) referring severe cases to emergency services, EMTs performing a phone assessment for non-severe cases, and EMTs traveling to the child's household to perform an in-person exam, rapid diagnostic testing for malaria where indicated as per protocol, and to deliver protocolized medications for cases within a predefined delivery zone.

EMTs and the protocols/guidelines used are supervised by Ghanaian and US physicians.

Clinical safety and feasibility of the TMDS will be evaluated using patient and logistical metrics.

Eligibility Criteria:
Child Participant Inclusion Criteria:

* Child ≤ 10 years
* Has an acute medical problem
* Provides written assent (if 10 years and receives a household visit)

Child Participant Exclusion Criteria:

* Child \> 10 years
* Child does not have an acute medical problem
* Medical problem involves physical trauma or mental health
* Refusal of written assent (if 10 years and receives a household visit)

Parent/Guardian Participant Inclusion Criteria:

* Calls MotoMeds during operating hours
* Parent/guardian of a patient participant meeting inclusion criteria
* Adult (18 years or older)
* Provides written consent (household visit) or a waiver of documentation of consent (no household visit)

Parent/Guardian Participant Exclusion Criteria:

* Age \< 18 years
* No written consent or waiver of documentation of consent
* Corresponding child does not meet inclusion criteria
Use of Different Diagnostic Coronary Catheters Over the Radial Access - the UDDC - Radial Trial

There is no evidence from prospective randomized clinical trials regarding the performance of conventional (two-catheter-concept; TCC) versus one-catheter-concepts (OCC) for invasive coronary angiography over the radial access.

The aim of the present trial is to evaluate the efficacy and safety of different one-catheter concepts by use of the BLK and Tiger catheter compared to a TCC using standard Judkins catheters in diagnostic coronary angiography via transradial access. Patients with stable angina pectoris will be randomly assigned to coronary angiography performed with the BLK or Tiger (OCC) or Judkins catheters (TCC). The primary endpoint is coronary angiography duration.

The aim of the present trial is to evaluate the efficacy and safety of a one-catheter concept using the BLK (Terumo, Somerset, USA) or the Tiger catheter (Terumo, Somerset, USA) compared to the standard Judkins catheters in diagnostic coronary angiography by the transradial access. Patients with stable angina pectoris will be randomly assigned to coronary angiography performed with the BLK (Group I), Tiger (Group II) or Judkins catheters (Group III). Primary endpoint is the time duration (sec) that is necessary to perform complete coronary angiography including 6 different projections for the left-coronary system and 3 different projections of the right-coronary-system. Secondary endpoints will cover safety and imaging quality of the different catheter systems.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years and ≤ 95 years
* Body weight \> 60kg

Exclusion Criteria:

* Acute coronary syndrome or cardiogenic shock
* Contraindications for transracial access such as absence of radial pulse or abnormal Allen test
* Prior unsuccessful transradial coronary angiography
* Estimated glomerular filtration rate \<40 ml/kg/min
* Patients not able to give informed consent
* Participation in another trial
A Study to Evaluate Glucose and Insulin Response to Nutralin

The purpose of this study is to evaluate how an investigational food product affects a healthy person's blood sugar and insulin levels.

The investigational food product has helped decrease the amount of insulin needed in treating diabetic dogs and has improved the dogs' longevity and quality of life. Observational analysis by trained veterinarians has indicated that the natural fluctuations in blood glucose levels do not exist in dogs using the product. The hypothesis for this study is that healthy human subjects will have an increase in insulin levels after consuming the investigational food product.

Eligibility Criteria:
Inclusion Criteria:

* Men and women who are at least 18 years of age
* Non-diabetic

Exclusion Criteria:

* Diabetes
* Women who are pregnant, breastfeeding or planning to become pregnant
* Current and active liver or kidney disease
* Any food allergies
* Celiac disease
Can a 6-minute Walking or Resting Break Improve Executive Function in Gamers.

This study will ask ranked first person shooters in esports to participate on three separate days from their home computer to test executive function prior tp play and following two hours of play. One testing day will incorporate a 6 minute walk break, another day will incorporate a 6 minute rest break, and the third day will be continuous play. Executive tests will be administered electronically prior to game play and post game play.

A ranked first person shooter player will play for two hours each session, and on separate days will take a 6 minute walking break or a 6 minute resting break within 2 hours of game play. This study is virtual and you may play from your regular home gaming computer. The third day will be continuous play.

The study will take place on 3 separate days. Preferably 2 -3 days in -between testing days.

* Participants will sign an electronic consent form to sign and agree to participate. It will explain the study in detail.
* Participants will then be asked to take two executive function tests online. These test will be sent electronically through email. This is for practice. These tests take approximately 6-7 minutes.
* We will schedule one day where the participant will play a first -person shooter game. Prior to playing the participants will be take to take the two executive function tests.
* On one day the participant will be asked to stop after the first hour (they will be allowed to finish the test) they will either walk for 6 minutes near their computer or rest for 6 minutes. Participants will be contacted through cell phones or discord.
* Game play will resume normally for another hour. When that hour is completed the participant will be asked to take the two online tests again.
* This will be 2 days. The third day the participant will take the online tests and play continuous for 2 hours with no break and then repeat the online tests.

Eligibility Criteria:
Inclusion Criteria:1. Women or men 18-25 years of age 2. Play first-person shooter games with a ranking of "gold" or higher (self reported).

-

Exclusion Criteria:1. Any participants that do not have a competitive ranking 2. Any participants that are colorblind (self reported) 3. Any participants that have sustained previous hand injuries within the last year, or suffer from chronic wrist pain.

-
A Study to Evaluate the Effectiveness of Cosopt® as First Line Therapy (MK-0507A-153)

Evaluate the effectiveness of dorzolamide-timolol (Cosopt®) as first line therapy in reducing intraocular pressure in patients with untreated Open angle glaucoma (OAG) or Ocular hypertension (OH).


Eligibility Criteria:
Inclusion Criteria:

* Patient has been recently diagnosed and is presently untreated for Open-Angle Glaucoma Or Ocular Hypertension With An iop of at least 27 mmhg in at least one eye (patient's worse eye)
* Patient Already Diagnosed With Open-Angle Glaucoma Or Ocular Hypertension And Untreated For At Least 30 Days Are Eligible For The Study If They Have An Iop Of 27 Mmhg Or More In At Least One Eye

Exclusion Criteria:

* A History Of Any Illness That, In The Opinion Of The Investigator, Might Confound The Results Of The Study Or Pose Additional Risk By Administering Dorzolamide-Timolol (Cosopt®) Or Prostaglandins
* The Presence Of Any Fundus Pathology Likely To Change During The Study Or To Influence Iop (Background Of Diabetic Retinopathy Is Permitted)
* Any Contraindication To The Use Of Cosopt® Including: - Bronchospasm, Including Bronchial Asthma Or A History Of Bronchial Asthma Or Chronic Obstructive Pulmonary Disease. - Sinus Bradycardia, Second Or Third Degree Av Block, Cardiac Failure (Grade Iii And Iv), Cardiogenic Shock
* Patient On Oral Carbonic Anhydrase Inhibitor, Concomitant Systemic Or Dermatological Medication Known To Affect The Iop, E.G. Clonidine, Corticosteroids, Oral Beta-Blocking Agents
* Pregnant Woman Or A Woman Of Childbearing Potential Who Is Sexually Active And Not Using An Acceptable Method Of Contraception (For Ex: Oral Contraceptive, Diaphragm, Contraceptive Sponge, Intra-Uterine Device, Long-Acting Contraceptive Injections, Double-Barrier Methods) Beginning At Least 7 Days Prior To Treatment And Continuing At Least 14 Days After The Last Visit Or The Discontinuation Visit. (Women Who Are Postmenopausal Or Have Received A Hysterectomy Or Have Undergone Tubal Ligature Are Considered As Not Having Childbearing Potential.)
* Severe Renal Impairment (Serum Creatinine \> 150 umol/L Or Creatinine Clearance \< 30 ml/min)